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Ultimate Calibration 2nd Edition
Beamex is a technology and service company that develops, manufactures and markets high-quality calibration equipment, software, systems and services for the calibration and maintenance of process instruments. The company is a leading worldwide provider of integrated calibration solutions that meet even the most demanding requirements. Beamex offers a comprehensive range of products and services-from portable calibrators to workstations, calibration accessories, calibration software, industry-specific solutions and professional services. Through Beamex’s global and competent partner network, their products and services are available in more than 60 countries. As a proof of Beamex’s success, there are more than 10,000 companies worldwide utilizing their calibration solutions. Several companies have been Beamex’s customer since the establishment of the company over 30 years ago. For more information about Beamex and its products and services, visit www.beamex.com
Beamex has used reasonable efforts to ensure that this book contains both accurate and comprehensive information. Notwithstanding the foregoing, the content of this book is provided “as is” without any representations, warranties or guarantees of any kind, whether express or implied, in relation to the accuracy, completeness, adequacy, currency, quality, timeliness or fitness for a particular purpose of the content and information provided on this book. The contents of this book are for general informational purposes only. Furthermore, this book provides examples of some of the laws, regulations and standards related to calibration and is not intended to be definitive. It is the responsibility of a company to determine which laws, regulations and standards apply in specific circumstances.
Ultimate Calibration 2nd Edition Copyright © 2009–2012 by Beamex Oy Ab. All rights reserved. No part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without the prior written permission of Beamex Oy Ab. Requests should be directed to firstname.lastname@example.org. Beamex is a trademark of Beamex Oy Ab. All other trademarks or trade names mentioned in this book are the property of their respective holders.
Graphic design: Studio PAP Photos: Mats Sandström and image bank Printed by: Fram in Vaasa 2012, Finland
Contents Preface by the CEO of Beamex Group 7 QUALITY. REGULATIONS AND TRACEABILITY Quality standards and industry regulations 11 A basic quality calibration program 35 Traceable and efficient calibrations in the process industry 57 CALIBRATION MANAGEMENT AND MAINTENANCE Why Calibrate? What is the risk of not calibrating? 73 Why use software for calibration management? 79 How often should instruments be calibrated? 89 How often should calibrators be calibrated? 97 Paperless calibration improves quality and cuts costs 101 Intelligent commissioning 107 Successfully executing a system integration project 115 CALIBRATION IN INDUSTRIAL APPLICATIONS The benefits of using a documenting calibrator 125 Calibration of weighing instruments Part 1 131 Calibration of weighing instruments Part 2 137 Calibrating temperature instruments 143 Calculating total uncertainty of temperature calibration with a dry block 149 Fieldbus transmitters must also be calibrated 157 Configuring and calibrating smart instruments 163 Calibration in hazardous environments 169 The safest way to calibrate to calibrate Fieldbus instruments 175 APPENDIX: Calibration terminology A to Z 181 .
foreword 6 .
I hope this book will assist you in learning new things and in providing fresh. and how to lower the risk of human errors. temperature calibration and configuring. I want to express my special thanks to Pamela at Beamex Marketing. and calibration of smart instruments. who was the key person in organizing and leading the project for the 2nd edition. ceo. systems or work processes within a company or production plant. Presently. All of these challenges can be tackled by improving the level of system integration and automation. Enjoy your reading! raimo ahola. how to eliminate double work. This book is the 2nd edition of Ultimate Calibration. new ideas. A team of experts in industry and calibration worldwide has put forth effort to its creation. Beamex aims to be the benchmark in the industry.preface by the ceo of beamex group Preface C alibrators. The main changes to this edition include numerous new articles and a new grouping of the articles to make it easier to find related topics. Calibration and calibrators can no longer be considered as isolated. calibration software and other related equipment have developed significantly during the past few decades in spite of the fact that calibration of measurement devices as such has existed for several thousands of years. the primary challenges of industrial metrology and calibration include how to simplify and streamline the entire calibration process. The new topics covered in the edition mainly discuss paperless calibration. This book is the result of work that has taken place between 2006 and 2012. stand-alone devices. how to reduce production down-time. I would like to thank all of the people who have contributed to this book. intelligent commissioning. calibration procedures need to be automated to a higher degree and integrated to achieve improvements in quality and efficiency. Just like any other business function. On behalf of Beamex. In this area. beamex group 7 .
Regulations and Traceability .Quality.
K.C. advanced to the stage of science. 1215) When you can measure what you are speaking about and express it in numbers. 1st Baron Kelvin. (Clause 35. the Egyptian unit of length came into being.. Surely it is the better part of thought that relies on measurement and calculation. The Egyptians studied the science of geometry to assist them in the construction of the Pyramids. The “Royal Egyptian Cubit” was decreed to be equal to the length of the forearm from the bent elbow to the tip of the extended middle 11 .A. beer.) There shall be standard measures of wine. OM.1 One of the earliest records of precise measurement is from Egypt. (William Thomson. and the clerk of the scales.C. but you have scarcely. here is a reminder from times past about measurement practices and how important they really are. 360 B. (Plato. but when you cannot express it in numbers. is beautifully restored by measuring. numbering and weighing. and a standard width of dyed russet and cloth. It may be the beginning of knowledge. Magna Carta. your knowledge is of a meager and unsatisfactory kind. thus confused by false appearance. Immersion in water makes the straight seem bent. 26 June 1824–17 December 1907. PRS. A. and corn… throughout the whole of our kingdom.quality standards and industry regulations Calibration requirements according to quality standards and industry regulations B efore going into what the current standards and regulations actually state. but reason. GCVO. It is believed that about 3000 years B. the computer. PC. The Republic. these drive vague notions of greater or less or more or heavier right out of the minds of the surveyor. and there shall be standard weights also. you know something about it. in your thoughts. Lord Kelvin).
a set of guidelines are used to write their quality manual and other standard operating procedures (SOPs) and they show how they comply with the standard.05%. The biggest difference between the two is simple – ISO standards are voluntary. 12 . In Europe.43 centimeters. the Egyptians achieved surprising accuracy.quality standards and industry regulations finger plus the width of the palm of the hand of the Pharaoh or King ruling at that time.36276 meters. etc. Through the use of cubit sticks. Thousands of workers were engaged in building the Great Pyramid of Giza. pyramids. In the case of ISO standards. Failure to do so was punishable by death.Volume 4 of “The rules governing medicinal products in the European Union”. The need for calibration has been around for at least 5000 years. Workers engaged in building tombs. they achieved an accuracy of 0. the Egyptians had anticipated the spirit of the present day system of legal metrology. and regulatory requirements are mandatory. they pay a company to audit them to that standard to ensure they are following their quality manual and are within compliance. Though the punishment prescribed was severe. If an organization volunteers to meet ISO 9000 standards.2 The “Royal Cubit Master” was carved out of a block of granite to endure for all times. detailed information for achieving regulatory compliance is provided in Eudralex . traceability and calibration recall. they are inspected by government inspectors for compliance to federal regulations. if a company is manufacturing a drug that must meet regulatory requirements. they were within 4. On the other hand. there are basically two types of requirements: ISO standards and regulatory requirements. The Royal Architect or Foreman of the construction site was responsible for maintaining & transferring the unit of length to workers instruments. the federal regulations specify in greater detail what a company must do to meet the requirements set forth in the Code of Federal Regulations (CFRs). standards. temples. However.5 inches or 11. With this standardization and uniformity of length. In roughly 756 feet or 230. They were required to bring back their cubit sticks at each full moon to be compared to the Royal Cubit Master. In today’s calibration environment. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) aims to improve harmonisation of Good Manufacturing Practice (GMP) standards and guidance documents. were supplied with cubits made of wood or granite.
Subpart D – Document Controls § 820.5 – Quality system. Subpart G – Production and Process Controls § 820.30 – Design controls. that relate to the calibration of test equipment in different situations and environments. TITLE 21 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H – MEDICAL DEVICES PART 820 QUALITY SYSTEM REGULATION 22 Subpart A – General Provisions § 820.75 – Process validation. and test equipment. Food and Drug Administration (FDA) Following are examples of some of the regulations required by the FDA.20 – Management responsibility. and what they say about calibration and what must be accomplished to meet the CFRs. § 820. 13 . § 820.25 – Personnel. Please note that European standards are similar to FDA requirements. § 820. § 820. Subpart B – Quality System Requirements § 820. Listed below are several different parts of 21CFR.quality standards and industry regulations Calibration requirements according to the U.72 – Inspection. Subpart F – Identification and Traceability § 820. § 820.65 – Traceability.50 – Purchasing controls.3 – Definitions.60 – Identification. S. measuring.1 – Scope. § 820.22 – Quality audit.40 – Document controls. § 820.70 – Production and process controls. Subpart C – Design Controls § 820. Subpart E – Purchasing Controls § 820.
140 – Handling. Subpart I – Nonconforming Product § 820. § 820.120 – Device labeling.130 – Device packaging.80 – Receiving.72] TITLE 2 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H – MEDICAL DEVICES 14 . § 820. Distribution. and finished device acceptance.250 – Statistical techniques.200 – Servicing. Subpart N – Servicing § 820. 2012] [CITE: 21CFR820.160 – Distribution.100 – Corrective and preventive action.86 – Acceptance status.180 – General requirements. Storage. § 820. Subpart L – Handling.90 – Nonconforming product. § 820. [Code of Federal Regulations] [Title 21. Subpart M – Records § 820. in-process. § 820. § 820.170 – Installation.184 – Device history record. Volume 8] [Revised as of April 1. § 820.186 – Quality system record.181 – Device master record. Subpart O – Statistical Techniques § 820. § 820. and Installation § 820.quality standards and industry regulations Subpart H – Acceptance Activities § 820. Subpart J – Corrective and Preventive Action § 820.150 – Storage.198 – Complaint files. Subpart K – Labeling and Packaging Control § 820. § 820.
measuring. the manufacturer shall establish and maintain an in-house standard. automated. If national or international standards are not practical or available. 820. 15 . inspected. so that its accuracy and fitness for use are maintained. and storage of equipment. When accuracy and precision limits are not met. including mechanical. The equipment identification. These activities shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment. calibration dates. The procedures shall include provisions for handling. checked. Each manufacturer shall ensure that all inspection. measuring. These activities shall be documented. Calibration procedures shall include specific directions and limits for accuracy and precision. the individual performing each calibration. (b) Calibration. (2) Calibration records. is suitable for its intended purposes and is capable of producing valid results. (a) Control of inspection. and test equipment. measuring. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated. (1) C alibration standards. and maintained. and test equipment. and test equipment. the manufacturer shall use an independent reproducible standard. Calibration standards used for inspection.quality standards and industry regulations PART 820–QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls Sec. measuring.72 Inspection. or electronic inspection and test equipment. preservation. and the next calibration date shall be documented. there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. and test equipment shall be traceable to national or international standards. If no applicable standard exists.
16 . and holding of a drug product.160 General requirements. including computers. drug product containers. in-process materials. drug product containers. packing. mechanical. closures. Volume 4] [Revised as of April 1. closures. 211.68 Automatic. and electronic equipment. it shall be routinely calibrated. Laboratory controls shall include: (1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components. and purity. or checked according to a written program designed to assure proper performance. sampling plans. processing. and test procedures designed to assure that components. or electronic equipment or other types of equipment. may be used in the manufacture. and drug products conform to appropriate standards of identity. standards. 2012] [CITE: 21CFR211] TITLE 21 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C – DRUGS: GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart D – Equipment Sec. strength. 211. inspected. If such equipment is so used.quality standards and industry regulations [Code of Federal Regulations] [Title 21. Written records of those calibration checks and inspections shall be maintained. mechanical. (b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications. or related systems that will perform a function satisfactorily. quality. labeling. Sec. (a) Automatic.
limits for accuracy and precision. processing. apparatus. packing. and recording devices not meeting established specifications shall not be used. (4) The calibration of instruments. 8. and provisions for remedial action in the event accuracy and/or precision limits are not met. Such procedures shall also require appropriate retesting of any component. apparatus. Samples shall be representative and adequately identified. (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. (d) Complete records shall be maintained of the periodic calibration of laboratory instruments.quality standards and industry regulations and labeling used in the manufacture. [43 FR 45077. Such samples shall be representative and properly identified. Such samples shall be representative and properly identified. or closure that is subject to deterioration. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. 211. schedules. drug product container. and recording devices required by 211. Sept. gauges. apparatus. as amended at 73 FR 51932. gauges. 29. Instruments. Sept. The specifications shall include a description of the sampling and testing procedures used.194 Laboratory records.160(b)(4). 17 . 2008] Sec. 1978. gauges. and recording devices at suitable intervals in accordance with an established written program containing specific directions. or holding of drug products.
quality standards and industry regulations
TITLE 2 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A – GENERAL PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A – General Provisions Sec. 11.1 Scope. (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. (c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997. (d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with 11.2, unless paper records are specifically required.
quality standards and industry regulations
(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection. (f) This part does not apply to records required to be established or maintained by 1.326 through 1.368 of this chapter. Records that satisfy the requirements of part 1, subpart J of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part. [62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004] Sec. 11.2 Implementation. (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. (b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that: (1) The requirements of this part are met; and (2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission. 19
quality standards and industry regulations
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A--GENERAL PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart C – Electronic Signatures Sec. 11.100 General requirements. (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual`s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. (c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 12420 Parklawn Drive, RM 3007 Rockville, MD 20857. (2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer`s handwritten signature.
quality standards and industry regulations
Calibration requirements according to the European Medicines Agency (EMA) Following are examples of some of the regulatory requirements of the EMA, and what they say about calibration and what must be accomplished to meet the GMPs. Eudralex Volume 4 Chapter 3: Premises and Equipment Equipment 3.41 Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained. Chapter 4: Documentation Manufacturing Formula and Processing Instructions Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured. 4.18 The Processing Instructions should include: a) A statement of the processing location and the principal equipment to be used; b) The methods, or reference to the methods, to be used for preparing the critical equipment (e.g. cleaning, assembling, calibrating, sterilising); c) Checks that the equipment and work station are clear of previous products, documents or materials not required for the planned process, and that equipment is clean and suitable for use; d) Detailed stepwise processing instructions [e.g. checks on materials, pre-treatments, sequence for adding materials, critical process parameters (time, temp etc)]; e) The instructions for any in-process controls with their limits; f ) Where necessary, the requirements for bulk storage of the products; including the container, labeling and special storage conditions where applicable; g) Any special precautions to be observed.
cleaning or repair operations. • Maintenance.29 There should be written policies.31 Logbooks should be kept for major or critical analytical testing. as appropriate. • Equipment assembly and calibration. maintenance. reports and the associated records of actions taken or conclusions reached. and areas where product has been processed. • Complaints. • Change control. They should be used to record in chronological order.quality standards and industry regulations Procedures and records Other 4. 22 . • Supplier audits. • Returns. • Pest control. • Personnel matters including signature lists.g. calibrations. production equipment. product quality review). • Investigations into deviations and non-conformances. clothing and hygiene and verification of the effectiveness of training. procedures. • Environmental monitoring. • Recalls. • Internal quality/GMP compliance audits. equipment and systems. for the following examples: • Validation and qualification of processes. where appropriate. • Summaries of records where appropriate (e. equipment/method. 4. cleaning and sanitation. including the dates and identity of people who carried these operations out. any use of the area. training in GMP and technical matters. • Technology transfer. protocols.
services and instrumentation checked to current engineering drawings and specifications.quality standards and industry regulations Chapter 6 Quality Control Good Quality Control Laboratory Practice Documentation 6.7 Laboratory documentation should follow the principles given in Chapter 4. where required. • validation records of test methods. • analytical reports and/or certificates. • data from environmental monitoring. IQ should include. Installation qualification (IQ ) should be performed on new or modified facilities. but not be limited to the following: (a) installation of equipment. (b) icollection and collation of supplier operating and working instructions and maintenance requirements. • sampling procedures. • procedures for and records of the calibration of instruments and maintenance of equipment. (c) icalibration requirements. (d) verification of materials of construction. where applicable. An important part of this documentation deals with Quality Control and the following details should be readily available to the Quality Control Department: • specifications. • testing procedures and records (including analytical worksheets and/ or laboratory notebooks). piping. 12. 23 . systems and equipment. Annex 15 to the EU Guide to Good Manufacturing Practice Title: Qualification and validation QUALIFICATION Installation qualification 11.
(g) additional testing to be carried out. operating procedures and operator training procedures and records should be documented. the calibration. systems and equipment.quality standards and industry regulations Operational qualification 15. operating and cleaning procedures. 24 . Qualification of established (in-use) facilities. with acceptance criteria and analytical validation. (i) methods for recording and evaluating results (j) functions and responsibilities. Evidence should be available to support and verify the operating parameters and limits for the critical variables of the operating equipment. (e) list of analytical methods. systems and equipment 19. It should permit a formal “release” of the facilities. as appropriate. (f) proposed in-process controls with acceptance criteria. as appropriate. Additionally. preventative maintenance. The completion of a successful Operational qualification should allow the finalisation of calibration. (k) proposed timetable. operator training and preventative maintenance requirements. Prospective validation should include. PROCESS VALIDATION Prospective validation 24. (b) summary of the critical processing steps to be investigated. cleaning. but not be limited to the following: (a) short description of the process. (h) sampling plan. (c) list of the equipment/facilities to be used (including measuring/ monitoring/recording equipment) together with its calibration status (d) finished product specifications for release.
Volume 4 Good manufacturing practice (GMP) Guidelines: http://ec.quality standards and industry regulations EU GMP Annex 11 The EU GMP Annex 11 defines EU requirements for computerised systems.eu/health/documents/eudralex/vol-4/index_en.europa. Main page for the EudraLex .europa. This document provides guidance for the interpretation of the principles 25 .pdf EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels. SANCO/C8/AM/sl/ares(2010)1064599 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. and applies to all forms of computerised systems used as part of GMP regulated activities.htm PDF of Annex 11: http://ec.eu/health/files/eudralex/vol-4/annex11_01-2011_ en.
Consequential amendments are also proposed for Chapter 4 of the GMP Guide. Status of the document: revision 1 Reasons for changes: the Annex has been revised in response to the increased use of computerised systems and the increased complexity of these systems. there should be no resultant decrease in product quality. B-1049 Bruxelles / Europese Commissie.Belgium Telephone: (32-2) 299 11 11 Principle This annex applies to all forms of computerised systems used as part of a GMP regulated activities. Further information can be found at the PIC/S Web site (http://www. There should be no increase in the overall risk of the process.). Where a computerised system replaces a manual operation. 26 . A computerised system is a set of software and hardware components which together fulfill certain functionalities. B-1049 Brussel . It aims to promote harmonisation of global regulations for the pharmaceutical industry. The application should be validated. picscheme. Deadline for coming into operation: 30 June 2011 Commission Européenne.quality standards and industry regulations and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.org/. process control or quality assurance. IT infrastructure should be qualified. PIC/S The abbreviation PIC/S describes both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) which operate together.
produce technical content and translate ISPE technical documents. GAMP® Europe. GAMP® Francophone.quality standards and industry regulations GAMP® GAMP® is a Community of Practice (COP) of the International Society for Pharmaceutical Engineering (ISPE).A Companion Volume to GAMP® 5 • GAMP® Good Practice Guide: Electronic Data Archiving • GAMP® Good Practice Guide: Global Information Systems Control and Compliance 27 . COPs provide networking opportunities for people interested in similar topics. There is also a series of related GAMP® guidance on specific topics. The GAMP® COP organizes discussion forums for its members and ISPE organises GAMP® related training courses and educational seminars. Several local GAMP® COPs. Switzerland). They also bring the GAMP® community closer to its members. the organization entered into a partnership with the ISPE and published its first GAMP® guidelines. GAMP® DACH (Germany. GAMP® Nordic. in collaboration with ISPE’s local Affiliates in these regions. GAMP® Italiano and GAMP® Japan. GAMP® Japan. GAMP® itself was founded in 1991 in the United Kingdom to deal with the evolving FDA expectations for Good Manufacturing Practice (GMP) compliance of manufacturing and related systems. Austria. The most well known GAMP® publication is GAMP ® 5 A RiskBased Approach to GxP Computerized Systems. This is the latest major revision and was released in January 2008. and GAMP® Americas support the GAMP® Council which oversee the operation of the COP and is the main link to ISPE. such as GAMP® Americas. Since 1994. Three regional Steering Committees. including: • GAMP ® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) • GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) • GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) • GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems . The GAMP® COP aims to provide guidance and understanding concerning GxP computerized systems.
The Guide describes the principles of calibration and presents guidance in setting up a calibration management system. • Calibrate your monitoring and measuring equipment using a period schedule to ensure that results are valid (you should also perform a yearly evaluation of your calibration results to see if there is a need to increase or decrease your calibration intervals on calibrated test equipment). and select test equipment that can meet those monitoring and measuring needs and requirements. this is what is required according to ISO 9001:2008 7. The scope now includes related industries. calibration program management. • Establish monitoring and measuring processes (calibration procedures and calibration record templates for recording your calibration results). documentation. A set of associated attachments are also available through the ISPE website. it requires periodic calibration). 28 . and corrective actions vital to regulatory compliance. The second edition of the guide has been significantly updated to address the change in regulatory expectations and in associated industry guidance documents. providing a structured approach to instrument risk assessment. laboratory.quality standards and industry regulations • GAMP® Good Practice Guide: IT Infrastructure Control and Compliance • GAMP® Good Practice Guide: Legacy Systems The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (second edition) was developed by ISPE’s GAMP® COP Calibration Special Interest Group (SIG) in conjunction with representatives from the pharmaceutical industry and input from regulatory agencies.6 CONTROL MONITORING AND MEASURING EQUIPMENT • Identify your organization’s monitoring and measuring needs and requirements (if your test instrument makes a quantitative measurement. and analytical instrumentation. All calibrations must be traceable to a national or international standard or artifact. ISO 9001:2008 Basically.
quality standards and industry regulations • Protect your monitoring and measuring equipment (this includes during handling. then you do not have any obligation to meet the ISO 17025 standard. rather it be for compliance to an ISO standard (ISO 9001:2008 or ISO 13485) or an FDA requirement (cGMP. and shipping of all test instruments – to include your customer’s items. Please keep in mind that if your calibration function and/or metrology department fall under the requirements of your company. QSR. and your calibration standards).). preservation. there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality”. You already fall under a quality system that takes care of your calibration requirements. • Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out-ofcalibration (as stated in the FDA regulations. etc. storage. second-. and laboratories where testing and/or calibration forms part of inspection and product certifications. transportation. 29 . especially when the out of tolerance item is a calibration standard. and may have affected numerous items of test equipment over a period of time). this standard is applicable to all organizations performing tests and/or calibrations.3-2006 ANSI/NCSL Z540. According to ISO 17025. this is just as applicable when dealing with ISO as with any other standard or regulation. ISO 17025 ISO 17025 – General requirements for the competence of testing and calibration laboratories. • Confirm that monitoring and measuring software is capable of doing the job you want it to do (your software needs to be validated before being used.3-2006 – American National Standard for Calibration-Requirements for the Calibration of Measuring and Test Equipment. your test instruments may need to be qualified prior to use). ANSI/NCSL Z540. These include first-. and when required. “When accuracy and precision limits are not met. and third-party laboratories.
or purchaser that receives a product or service. Reference to this National Standard may be made by: • customers when specifying products (including services) required. these components are used to manage and assure that the accuracy and reliability of the measuring and test equipment are in accordance with identified performance requirements.quality standards and industry regulations The objective of this National Standard is to establish the technical requirements for the calibration of measuring and test equipment. vendor. • suppliers when specifying products offered. • the compatibility of measurements with the National Measurement System. or information. 30 . In addition. • the suitability of a calibration for its intended application. • applying best practices and experience with related national. In implementing its objective. international.1 (R2002) and Military Standard 45662A. or a provider of a product. this National Standard describes the technical requirements for establishing and maintaining: • the acceptability of the performance of measuring and test equipment. This National Standard is written for both Supplier and Customer. and other evaluations of calibration systems and their components. retailer. client. Collectively. and • assessment organizations in the audit. Part 11 of ANSI/NCSL Z540. enduser. This is done through the use of a system of functional components. industry. In the development of this National Standard attention has been given to: • expressing the technical requirements for a calibration system supporting both government and industry needs. service. each term being interpreted in the broadest sense. The “Supplier may be a producer. and government standards. and • balancing the needs and interests of all stakeholders. certification. The “Customer” may be a consumer. distributor. • agencies or organizations as a contractual condition for procurement. • legislative or regulatory bodies. this National Standard includes and updates the relevant calibration system requirements for measuring and test equipment described by the previous standards. and • the traceability of measurement results to the International System of Units (SI).
quality standards and industry regulations
This National Standard is specific to calibration systems. A calibration system operating in full compliance with this National Standard promotes confidence and facilitates management of the risks associated with measurements, tests, and calibrations.8 Equipment intended for use in potentially explosive atmospheres (ATEX) What are ATEX and IECEx? ATEX (“ATmosphères EXplosibles”, explosive atmospheres in French) is a standard set in the European Union for explosion protection in the industry. ATEX 95 equipment directive 94/9/EC concerns equipment intended for use in potentially explosive areas. Companies in the EU where the risk of explosion is evident must also use the ATEX guidelines for protecting the employees. In addition, the ATEX rules are obligatory for electronic and electrical equipment that will be used in potentially explosive atmospheres sold in the EU as of July 1, 2003. IEC (International Electrotechnical Commission) is a nonprofit international standards organization that prepares and publishes International Standards for electrical technologies. The IEC TC/31 technical committee deals with the standards related to equipment for explosive atmospheres. IECEx is an international scheme for certifying procedures for equipment designed for use in explosive atmospheres. The objective of the IECEx Scheme is to facilitate international trade in equipment and services for use in explosive atmospheres, while maintaining the required level of safety. In most cases, test equipment that is required to be operated in an explosive environment would be qualified and installed by the company’s facility services department and not the calibration personnel. One must also keep in mind that there would be two different avenues for the calibration of those pieces of test equipment: on-site and off-site. If the test instrument that is used in an explosive environment must be calibrated on-site (in the explosive environment), then all the standards used for that calibration must also comply with explosive environment directives. However, if it were possible to remove the test equipment from the explosive environment when due for their period calibration, then there would be no requirement for the standards used for their calibration to meet the explosive
quality standards and industry regulations
environment directives, saving money on expensive standards and possibly expensive training of calibration personnel in order for them to work in those conditions. Having said that, there may be a need for the calibration personnel to be aware of the ATEX regulations. An informative website for information on ATEX can be found by typing in the following link: http://ec.europa.eu/enterprise/atex/indexinfor.htm. Several languages are available for retrieving the information. Another informative website is the International Electrotechnical Commission Scheme for Certification to Standards Relating to Equipment for use in Explosive Atmospheres (IECEx Scheme). The link is: http://www.iecex.com/guides.htm. 1. Bucher, Jay L. 2007. The Quality Calibration Handbook. Milwaukee: ASQ Quality Press. 2. The Story of the Egyptian Cubit. http://www.ncsli.org/misc/ cubit.cfm. (18 October, 2008) 3. 21CFR Part 211.68, 211.160: http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211/ (5 July, 2012) 4. 21CFR Part 11. http://www.fda.gov/downloads/ RegulatoryInformation/Guidances/ucm125125.pdf (5 July, 2012) and http://www.fda.gov/RegulatoryInformation/Guidances/ ucm125067.htm?utm_campaign=Google2&utm_ source=fdaSearch&utm_medium=website&utm_term=21 CFR part 11&utm_content=3 5. GAMP. http://en.wikipedia.org/wiki/Good_Automated_ Manufacturing_Practice (5 July, 2012) 6. NCSL International. 2006. ANSI/NCSL Z540.3-2006. Boulder, CO.
Without calibration. If all test equipment were calibrated to a traceable standard. The amount of drugs confiscated in a raid determines whether the offense is a misdemeanor or a felony. and possibly the ability to stay in business simply because they do not use calibrated test equipment. all of us pay more at the gas pump. Because of poor or incorrect calibration. for food weighed incorrectly at the checkout counter. then repeatable results would ensure that what’s made in one part of the company is also repeated in another part of the company. the cure for cancer is one of them. or even cause illness or death. having the correct measurements throughout any and all industries is critical to national and international trade and commerce. Measurements made by R&D are different than those made by the operations section. Babies are not correctly weighed at birth. Airliners fly into mountaintops and off the ends of runways because they don’t know their altitude and/or speed. or by using incorrect calibrations. money. criminals are either not convicted or are released on bad evidence. and for manufactured goods that do not meet their stated specifications. They are not using calibrated test instruments in the company. their reputation. The cure cannot be replicated with consistent results. Let’s imagine that the Acme Biotech Co. The company loses time. which weight is correct? As one can see. A fairy tale? Not hardly. Incorrect amounts of ingredients in your prescription and over-the-counter (OTC) drugs can cost more.a basic quality calibration program A basic quality calibration program R &D departments are tasked with coming up with the answers to many problems. Their R&D section sends the formula to their operations & manufacturing division. This scenario is repeated every day throughout the world. 35 . has found the cure for cancer. Crime labs cannot identify the remains of victims or wrongly identify victims in the case of mass graves.
align or repair the item. The comparison to a standard that is more accurate. The two examples in figures 1 and 2 are similar. usually national or international standards. Nothing could be further from the truth. When we talk about traceability to a national or international standard. before we go any further. let’s discuss the use of uncertainty budgets. Traceability is the property of the result of a measurement or the value of a standard whereby it can be related to stated references. It does not make any difference if you adjust. It is as simple as that. According to the European cooperation for Accreditation of Laboratories. and that is why it is being calibrated). By definition: Calibration is a comparison of two measurement devices or systems. no matter the circumstances is called calibration. Before we can get any deeper into what traceability is. or certain parts of the world. the purpose of which is to give guidance on the calibration and maintenance of measuring 36 . The calibration of any piece of equipment or system is simply a comparison between the standard being used (with its known uncertainty). so a graphic illustration of these pyramids is important. nor if you cannot adjust or align it. through an unbroken chain of calibrations all having stated uncertainties. we need to clarify two definitions that are critical to this subject – calibration and traceability. and the unit under test (UUT) or test instrument that is being calibrated (the uncertainty is unknown. we should explain two different traceability pyramids. Many people are under the misconception that an item must be adjusted or aligned in order to be calibrated. publication reference (EAL-G12) Traceability of Measuring and Test Equipment to National Standards. However. one of known uncertainty (your standard) and one of unknown uncertainty (your test equipment or instrument). the ‘everyday calibration technician’ is usually situated close to the bottom of the pyramid. but differ depending on where you are in the chain. and using a test uncertainty ratio (TUR) of ≥ 4:1. There are basically two ways to maintain traceability during calibration – the use of an uncertainty budget (performing uncertainty calculations for each measurement).a basic quality calibration program The bottom line is this – all test equipment that make a quantitative measurement require periodic calibration. First.
must measure with the ‘same measure’. 37 . paragraphs 4 and 5 are very specific in their requirements: 4 Why are calibrations and traceability necessary? 4. Secondary standards Reference standards Working standards User’s test equipment Figure 2 Note: NMI = National Metrology Institute equipment in meeting the requirements of the ISO 9000 series of standards for quality systems. supplier firms that make products.a basic quality calibration program BIPM NMIs Reference standards Working metrology labs General purpose calibration labs (inside a company) User’s test equipment Figure 1 SI units Primary stds. and customers who install them with other parts.1 Traceability of measuring and test equipment to national standards by means of calibration is necessitated by the growing national and international demand that manufactured parts be interchangeable. and the EN 45001 standard for the operation of testing laboratories.
by reference to a systematic and fully documented system. failure to meet these requirements means the absence of a warranted quality with considerable consequent liability. e. (f) re-calibrations. if they are used properly. was in proper working order and was used correctly for controlling a product. (e) reference to SI units. is not affected by defects. 4. the chain of comparisons must end at primary standards for the realization of the SI units. 38 . (d) competence.g. 5 Elements of traceability 5. 4.3 If it becomes necessary to prove absence of liability. the results must equally be documented.g. frequency of use. way of use.a basic quality calibration program 4. calibrations must be repeated at appropriate intervals. usually a national or international standard.2 There are legal as well as technical reasons for traceability of measurement. the producer must be able to demonstrate.4 There are similar technical and legal reasons why calibration and testing laboratory operators should have consistent control of measuring and test equipment in the manner described. Note: If binding requirements for the accuracy of measuring and test equipment have been stipulated. Relevant laws and regulations have to be complied with just as much as the contractual provisions agreed with the purchaser of the product (guarantee of product quality) and the obligation to put into circulation only products whose safety. the length of these intervals will depend on a number of variables. stability of the equipment. uncertainty required. the measurement uncertainty for each step in the traceability chain must be calculated according to agreed methods and must be stated so that an overall uncertainty for the whole chain may be calculated. by demonstrating that they are accredited.1 Traceability is characterised by a number of essential elements: (a) an unbroken chain of comparisons going back to a standard acceptable to the parties. (c) documentation. (b) measurement uncertainty. each step in the chain must be performed according to documented and generally acknowledged procedures. the laboratories or bodies performing one or more steps in the chain must supply evidence for their technical competence. e. that adequate measuring and test equipment was chosen.
Where does this ratio of four to one (4:1) come from? It comes from the American National Standard for Calibration – (ANSI/NCSL Z540. a calibration function can easily maintain traceable calibrations for the requirements demanded by their customers and the standard or regulation that their company needs to meet. if a TUR of equal to or greater than 4:1 is maintained.2 By understanding and following both of these documents. the TUR shall be equal to or greater than 4:1. It is equally important that such reference materials are traceable to relevant SI units. This is correct and acceptable.32006) which states: “Where calibrations provide for verification that measurement quantities are within specified tolerances…Where it is not practical to estimate this probability.a basic quality calibration program 5. published by seven international organisations concerned with standardisation and metrology. Keep in mind that a TUR of 4:1 somewhere along the chain of calibrations may not have been feasible. In most circumstances. Expression of the Uncertainty of Measurement in Calibration. As the rules laid down in this document are in compliance with the recommendations of the Guide to the Expression of Uncertainty in Measurement.” So. to set up. where the need to maintain a TUR of 4:1 comes into play. then traceability is assured. To maintain traceability.1 The other document that goes hand-in-hand with this is EA 4/02. the specific demands in reporting uncertainty of measurement on calibration certificates issued by accredited laboratories and to assist accreditation bodies with a coherent assignment of best measurement capability to calibration laboratories accredited by them. reference materials take the position of physical reference standards. in addition to the general requirements of EAL-R1. is at the company or shop level.2 In many fields. Certification of reference materials is a method that is often used to demonstrate traceability to SI units. The purpose of this document is to harmonise evaluation of uncertainty of measurement within EA. the implementation of EA-4/02 will also foster the global acceptance of European results of measurement. without using uncertainty budgets or calculations. where the customer’s test 39 . you must ensure your standards are at least four times (4:1) more accurate than the test equipment being calibrated. and uncertainty calculations were performed and their uncertainty stated on the certificate of calibration.
therefore. The two ‘old timers’ have a reduction in their production and actually cost the company money.a basic quality calibration program equipment is usually used for production or manufacturing purposes only. But they must have their calibration procedure on hand each time they are performing the calibration. They submit a change proposal for the calibration procedure and everyone is briefed and trained on the new technique. One of the four calibration technicians (who are always following the calibration procedures) finds there is a fast. then this would not have happened. This is applicable in every phase of a production and/or manufacturing program. We are not ignorant enough to believe that when calibration technicians have performed a particular calibration hundreds or even thousands of times that they are going to follow calibration procedures word for word. If everyone was using the calibration procedures like they were supposed to. Four of them work in another facility calibrating the same types of equipment as the other two. So how does calibration and traceability fit into the big picture? What does the big picture look like? Why do you need a quality calibration program? You need to establish a quality calibration program to ensure that all operations throughout the metrology department occur in a stable manner.3 Let’s take for example a calibration program that has six calibration technicians on staff. the calibration technician must be trained on the change before they can perform the calibration. Of course not. the other two have far more experience and through no fault of their own do not use the calibration procedures that are required by their quality system. They have calibrated the same items for several years and feel there is nothing new to learn. Once stability and consistency are achieved. However. The four calibration technicians that have been following the calibration procedure improve their production and save the company money. The effective operation of such a system will hopefully result in stable processes and. it is possible to initiate process improvements. and the appropriate documentation completed to show that training 40 . If a change has been made to that procedure. in a consistent output from those processes. Process improvements cannot take place across the department if everyone is not doing the job the same way each and every time they perform a calibration. more economical way to perform a specific calibration. But especially true in a metrology department.
3 “Say what you do” means write in detail how to do your job. “Do what you say” means follow the documented procedures or instructions every time you calibrate.) and regulations throughout most industries that regulate or monitor production and manufacturing of all types of products. One of the most stringent requirements can be found in the current Good Manufacturing Procedures (GMP). and Act on the difference”. accuracies. etc. Record what you did. Do what you say. work instructions and SOPs. Check the results. “Check the results” means make certain the test equipment meets the tolerances. Let’s break these down into simple terms. Here is an example of common formatting for SOPs: 41 . These items are also referred to by other standards (ISO 9000. you’re required to inform the user/owner of the equipment because they may have to re-evaluate manufactured goods. The basic premise and foundation of a quality calibration program is to “Say what you do. including what your standard(s) read or indicated both before and after any adjustments might be made. What is a quality calibration program? A quality calibration program consists of several broad items referred to in the Quality System Regulation (QSR) from the Food and Drug Administration (FDA). change a process. When the proper training is not documented and signed off by the trainer and trainee.a basic quality calibration program was accomplished and signed off. or recall a product. work instructions and standard operating procedures (SOPs). This includes calibration procedures. then it is the same as if the training never happened. All of your calibration procedures should be formatted the same as other SOPs within your company. “Record what you did” means that you must record the results of your measurements and adjustments. or upper/lower limits specified in your procedures or instructions. or perform a function that follows specific written instructions. This includes calibration procedures. “Say what you do” means write in detail how to do your job. “Act on the difference” means if the test equipment is out of tolerance.
This means following published calibration procedures every time you calibrate a piece of test equipment. Forms and Records 8. Then the actual calibration procedure starts in section 5. pressure and vacuum gages. Specific: spectrophotometers. Related Procedures 7. This table should also include the standard’s range and specifications. Procedures 2. two types of calibration procedures: Generic: temperature gages and thermometers. thermal cyclers. A complete calibration must be performed prior to any adjustment or alignment. Specific SOPs are written to show stepby-step procedures for each different type of test instrument within a group of items. Responsibilities 4. generally speaking. along with their range and tolerances. and removes doubt by the calibration technician on what data goes into which data field. There are. or perform a function that follows specific written instructions. After that you should have a list of the standards to be used to calibrate the items. An alignment procedure and/ or preventive maintenance inspection (PMI) may be incorporated into your SOP as long as it is separate from the actual calibration procedure.a basic quality calibration program 1. you should have a table listing all of the instruments or systems that would be calibrated by that procedure. and balances/scales. Procedure 6. pipettes. Possibly. Have the latest edition of the procedure available for use by your calibration technicians. Definitions. Document History After section 4. Definitions 5. micrometers. They should show what standards accomplish the calibration of a specific range and/or function. “Do what you say” means follow the documented procedures or instructions every time you calibrate. Manufacturer’s manuals usually provide an alignment procedure that can be used as a template for writing a calibration procedure. the calibration form is designed to follow specific steps (number wise). Procedures. power supplies and water baths. Scope 3. Have a system in place for updating your 42 . Generic SOPs are written to show how to calibrate a large variety of items in a general context.
prior to alignment.g. as well as the test instrument’s ‘As Found’ and when applicable ‘As Left’ readings.a basic quality calibration program procedures. or update your calibration procedures and/or forms? A formal. There should be a place to show what the standard read. If an out-of-tolerance (OOT) condition is found. 43 . The entire calibration is performed to see any part of the calibration is out of tolerance. A history of each calibration and a traceability statement or uncertainty budget must be included. Of course there are many ways to accomplish this. their part number and range/tolerance. Excel. including: • pen and paper • “do-it-yourself ” databases. The location of where the test instrument can be found should also be on the record. adjustment or repair. to include: • Who can make changes • Who is the final approval authority • A revision tracking system • A process for validating the changes • An archiving system for old procedures • Instructions for posting new/removal of old procedures • A system for training on revisions • A place to document that training was done “Record what you did” means that you must record the results of your measurements and adjustments. e. Access • calibration module of a computerized maintenance management system (CMMS) • calibration software specifically designed for that purpose These include the identification of the test instrument with a unique identification number. Train your technicians on the changes made to your procedures every time the procedure is changed or improved – and document the training. The ‘As Found’ readings are what the test instrument read the first time that a calibration is performed. including what your standard(s) read or indicated both before and after any adjustments are made. What do you do when you need to make an improvement. Certain requirements must be documented in each calibration record. and keep your calibration records in a secure location. written process must be in place. the last time it was calibrated. The date of calibration. and the next time it will be due calibration should be on the form.
collecting the ‘As Left’ readings for the final calibration record. Then. and the temperature standard is used to record the actual reading.a basic quality calibration program record the reading (on the standard and the UUT) and continue with the rest of the calibration to the end of the calibration procedure. it might be metrology department policy to adjust an item if it is more than ½ beyond its in-tolerance range. there is a good possibility that the adjustment affected other ranges or parts of the calibration. “As Left” readings are taken after repair. If the item is found to be out-of-tolerance at that time. 44 . the standard is set at a predetermined output. there would not be a problem since it was found to be in tolerance during the first calibration. Not all UUTs would be considered OOT when “As Left’ readings are taken. make an adjustment. there will be times when this is not possible. or adjustment. then proceed with the calibration. Another example would be when preventive maintenance inspection is going to be performed on an item. The water bath is set to a predetermined temperature. This should be noted in the calibration record. In this type of situation. If one were to stop at the point where an OOT is found. will also be recorded on the calibration form. There will be times when an instrument has a catastrophic failure. alignment or adjustment and that after a final adjustment was completed to bring the unit back into tolerance. while still meeting its specifications. However. a final ‘As Left’ calibration would be performed. from the working or reference standard you are using to calibrate the UUT. after the UUT is adjusted to be as close to optimum as possible. and the UUT is read to see how much it deviates from the standard. In some circumstances. One example when it would not be practical to set the standard and take a reading is during the calibration of water baths. It would be obvious that something happened during the cleaning. a complete calibration is again performed. The calibration is performed. The UUT is treated the same as any OOT unit. Compare this to the calibration of pressure gages where a pressure standard is set to a standard pressure. alignment. This is why the entire calibration is performed prior to adjustment or alignment. but you would not have been able to collect the original “As Found’ readings. Then the PMI is completed. collecting the ‘As Found’ data. The standard reading. and an ‘As Left’ set of data is collected. once the problem is found and repaired. This is a best practice policy that has been in use in the metrology community since calibration started. an ‘As Found’ calibration is performed. It just dies and cannot be calibrated. Usually.
paragraph 5.3-2006. You should include any uncertainty budgets if used. along with the procedure’s revision number. along with their next calibration due date(s).3. Also on the calibration form should be an area to identify the standard(s) that were used. etc. vibration. List environment conditions when appropriate and show if they pass or fail. If this is the case. monitored. paragraph 5. along with the standard.6 Influence factors and conditions: “All factors and conditions of the calibration area that adversely influence the calibration results shall be defined. and compared to the standard to see if they are in or out of tolerance. are placed in a dry block and a particular temperature is set. Note: Influencing factors and conditions may include temperature. just as the calibration of autoclaves.a basic quality calibration program and the gage(s) under test are then read. and a determination is made as to the in or out of tolerance of the UUT. and their pressures recorded on the calibration record. According to NCSL International Calibration Control Systems for the Biomedical and Pharmaceutical Industry – Recommended Practice RP-6. or at least a statement that a TUR of ≥ 4:1 was met. Calibration shall be stopped when the adverse effects of the influence factors ad conditions jeopardize the results of the calibration. electromagnetic interference.”5 If the conditions within the area that calibrations are being performed require monitoring according to the standard or requirements that must be met. dust. they are set to complete a sterilization cycle and a temperature device records all of the temperature readings throughout the cycle and the readings are checked to see if the autoclave met its specifications. The same happens when calibrating thermometers. humidity. then a formal program must be in place for tracking those conditions and reviewing the data. There should also be a place to identify which calibration procedure was used. to NIST. and mitigated to meet calibration process requirements. it is not always possible to set the standard and take a reading from the UUT. or in the case of most companies in the USA. The UUT is compared to the reference after equilibration. then there should be a place in the calibration form for showing that those conditions were 45 . As can be seen by the above examples. or to any artifact that was used as a standard. In other case. They.”4 According to ANSI/NCSL Z540.11: “The calibration environment need be controlled only to the extent required by the most environmentally sensitive measurement performed in the area. plus their specifications and range. There must be a statement showing traceability to your NMI. recorded.
Enough space should be available for the calibration technician to include information about the calibration. draw a single line through the entry. • The user/customer was notified and the UUT was taken out of service and tagged as unusable. must be informed if their test equipment does not meet their specifications. The user/customer. after recording your results. etc. If the UUT had an out-of-tolerance condition.) must review the calibration record and also sign and date that it has been reviewed. There should be an area set aside in the calibration form for making comments or remarks. What do you do if. Notice that in each circumstance that the user/customer must be notified of any and all OOTs. with the following possibilities as an example: • The user/customer was notified and the UUT was adjusted and meets specifications. • The user/customer was notified and the UUT was given a ‘limited calibration’ with their written approval. write the correct data. There should be only one way to file your records. there should be a place on the form for the final reviewer to sign and date. or make a duplicate record from scratch with the correct data and explain in the comments block what happened. or are not applicable to that calibration. even if internal to the company performing the calibrations. the calibration record requires a ‘second set of eyes’. This means that an individual higher up the chain of command (supervisor. and want to correct the error? For hard copy records. you find that you have made an error. etc. You should indicate on the form if the calibration passed or failed. QA inspector. OOT conditions. If this is the case. or inspected before it is considered a completed record. what was accomplished if an OOT was found. and date and sign accordingly. or transposed the wrong numbers. then there should be a place to show what happened to the UUT. or erase the original data. Do not use white-out. and then place your initials and date next to the data using black ink. the calibration record must be signed and dated by the technician performing the calibration. And finally. In some instances. were not met. both hard copy 46 . manager. This is called for in all of the standards and regulations. audited. use whatever tracking system the software uses.a basic quality calibration program either met. For making corrections to electronic records (eRecords).
data lines and storage systems when going entirely electronic with your calibration records and data management. It cannot be emphasized enough the criticality of validating your software. 47 . “Check the results” means make certain the test equipment meets the tolerances. In other cases it is not quite so apparent. calibration certificate number and calibration date • Placed on a secure drive that has regular backup • eRecords are filed within a specified time frame There are many different ways to manage your calibration data since there are a variety of ways to collect that data. accuracies. but also new problems in how to collect. should also be considered.. Is the system validated and instrumentation qualified prior to use? If you are using any type of computerized system. Hard copy records collected during the calibration of test instruments have been discussed in detail already. validation of that software is mandatory. review and store the data. There are various ways to do this. The use of computerized data collection brings with it not only increased productivity and savings in time and effort. But the collection of data by electronic means. manage. or through the use of calibration software. and eventual storage. In some instances it is apparent what the tolerances will be for the items being calibrated. analysis.a basic quality calibration program and eRecords – no matter which system you use. put it into your written procedures. How is the data collected and stored? Is it in its native format or dumped into a spreadsheet for analysis? All of these need to be considered to allow for review. process controllers. An example for filing hard copy records: • Each record is filed by its unique ID number • Records are filed with the newest in the front • Records are filed within a specified time frame An example for filing eRecords: • Filed by ID number. etc. Calibration forms should have the range and their tolerances listed for each piece of test equipment being calibrated. or upper/lower limits specified in your procedures or instructions. and/or compilation into your forms.
change a process or procedure. According to the FDA: “When accuracy and precision limits are not met. • Are there any databases that need to be updated. and a paper trail for historical reference? After owner/user notification. supervisor or manager? • Is a data base maintained on all OOT test equipment? • Is the customer/user required to reply to the OOT notification.” You should have a written procedure in place that explains in detail: • What actions are to be taken by the calibration technician? • What actions to be taken by the department supervisor and/or manager? • What actions to be taken by the responsible owner/user of the OOT test equipment? You should have an SOP that explains the responsibilities of the calibration technician: • Do they have additional form(s) to complete when OOT conditions are found? • Do they require a ‘second set of eyes’ when/if an OOT is found? • Have they been trained and signed off that they know all the proper procedures when an OOT has been found? You should have an SOP that explains the responsibilities of the supervisor/manager: • Who notifies the customer – the technician. or upper management notification in case of ‘in action’? 48 . if so is there a time limit.a basic quality calibration program “Act on the difference” means if the test equipment is out of tolerance. or recall product. is the calibration department responsible for anything else? • Is the final action by the owner/user sent back for filing or archiving? • Usually the department that generates an action item is responsible for final archiving. you must inform the user because they may have to re-evaluate manufactured goods. there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality.
generally 85% of test equipment passes calibration.a basic quality calibration program Do you have a database of all OOT test equipment for various activities? • The database can be used for accessing yearly calibration interval analysis. Here is a hypothetical example: from an historical perspective. • Among the 15% that are found to be OOT some will be due to Start Typical calibration process as shown in a flow chart ‘As found’ test Save ‘As found’ results NO Adjustment required? YES Adjust as needed ‘As Left’ test YES Within limits? NO Save ‘As Left’ results End 49 . • Access to OOT data can assist in determining reliability of test equipment. • During an audit/inspection (both internal and external) access to past OOT data should be easily available.
This can be compared to the person who is trying to drain the swamp while fighting off the alligators. and a visible safety program. along with traceability should be apparent to an auditor or inspector. the unseen portion is what keeps the iceberg afloat and stable in the ocean. Do what you say. The “Say what you do. bad cables/accessories. It is hard to keep your overdue calibrations at a minimum when all of your time is spent reacting to items that keep coming due without your prior knowledge. reverse traceability. and Act on the difference” portion. items that are OOT. From a managerial standpoint. Only about 10% can be easily seen by the casual observer. and other listings that help to manage your department. This can be accomplished using the manufacturer’s 50 . Without any one of these programs. • If a higher fail rate is noticed. Check the results. poorly written calibration procedures. But the different parts that keep a quality calibration program running efficiently consist of elements from a continuous process improvement program. groups of items by location/part number.). bad standards. the ability to see a 30 day schedule of items coming due calibration. scheduling and calibration management software. However. Having an effective calibration management program is usually the difference between being proactive and reactive to performing your routine calibrations. and the ability to see all items that are currently overdue calibration. standards. the calibration management program should also be able to show calibrations and repairs by individual items. By knowing what is coming due calibration. a comprehensive calibration analysis program. before changing calibration intervals. environmental conditions (vibration. an effective training program. Record what you did. any software program used must be validated prior to implementation. Developing a world-class calibration program A quality calibration program might be compared to an iceberg. correct and properly used calibration and equipment labels.a basic quality calibration program operator error. The same can be said of a quality calibration program. According to most standards and regulations. you can schedule your technicians. etc. time and other resources to the best advantage. a quality calibration program would be impossible to maintain. Any calibration management program worth the money should have a few critical areas built into their basic program. check that the proper specifications are being used. Those include: a master inventory list.
say outdoors in severe weather. This would be using your time to the best advantage. Also. Combining the calibration of like items and mixing and matching items could reduce the task of mundane and boring calibrations. if calibrations were to be performed in a ‘clean room’ environment. return to finish the pipette or balance calibrations. you are using your time more efficiently. then scheduling all of the calibrations in that area could increase production and reduce down time from multiple entries and exits. A particular item used in a controlled environment should be more reliable that one used in a harsher situation. An example of this would be to calibrate all pressure gages that were shown to be stored or used in a specific area. By not having to stand around to wait for the water baths to equilibrate. How often should each type of test equipment be calibrated? Should the manufacturer’s recommended interval be the determining factor? Or should the criticality of how the test equipment is used in your particular production or manufacturing line be the deciding vote? Your specific situation should be the driving factor in deciding calibration interval analysis. or floor of a building.a basic quality calibration program system. Most manufacturers recommend a 12 month calibration interval. then perform several pipette or balance calibrations. An example would be to start all temperature calibrations (set water baths up for their initial temperature readings). Calibration interval analysis software can be purchased commercially 51 . Each situation should be considered carefully so that they can be reviewed in the appropriate light. A best practice among experienced calibration practitioners is the calibration of like items. increasing productivity. and the calibration technician is required to gown-up prior to entry every time then go into the clean-room. depending on usage. Another critical yet often times misunderstood program is calibration interval analysis. etc. Also. or by incorporating an in-house validation system. environment. then complete the water baths at their final setting. handling. return to set another temperature in the water baths (doing a few at a time). and using your scheduling software to also perform calibrations in geographical areas or combining calibrations in local areas. Either way. your validation paperwork needs to be available for inspection during audits and inspections. and keeping the calibration technician involved and focused instead of bored. you must consider if the test equipment is used to determine final product where specifications are very tight. or used as an item that is coded as “No Calibration Required” on a loading dock.
Both management and technical information are presented in this RP. then take the result times 100 for the pass rate • Make a risk assessment of each item for your company’s needs. set a cut off for increasing or decreasing calibration intervals • Consider increasing a calibration interval if the pass rate ≥ 95% (by ½ up to double the current calibration interval) • Consider decreasing a calibration interval if the pass rate ≤ 85% (by ¾ to ½ of the current calibration interval) No matter which route you take for calibration interval analysis – ensure you are on the cutting-edge – not on the ragged-edge by extending your intervals too fast without solid data. Also. but 52 . NCSL International has RP-1. or are on a tight budget and are willing to do their own computations. Not only is calibration a requirement.a basic quality calibration program and used to evaluate your test equipment. adjustment and evaluation programs. Here is an example. Establishment & Adjustment of Calibration Intervals. • For each type of equipment. It provides information needed to design. recalls can be very expensive. implement and manage calibration interval determination. industries and even countries. and to your company’s reputation! The cost and risk of not calibrating Are there costs and/or risks associated to not calibrating your test equipment? This is a double edged sword. Several methods of calibration interval analysis and adjustment are presented. On one side we have the requirement of standards and regulations that govern various companies. The advantages and disadvantages of each method are described and guidelines are given to assist in selecting the best method for a requiring organization. collect data over a one year period on: number of calibrations and number of items OOT • Take the number of calibrations minus the number of OOTs. divide result by the number of calibrations. but one of the foundations for any quality system in the 21st century. It isn’t a question of do you have a quality calibration program in place. A company could also do their own analysis if they support a limited number of items. This Recommended Practice (RP) is intended to provide a guide for the establishment and adjustment of calibration intervals for equipment subject to periodic calibration. in time and money.
If a manufacturer produces any type of product or service where repeatable measurements take place then their test equipment/instruments need to have repetitive outputs. In the case of companies that have untraceable calibration in the production of medical devices. The cost is huge in terms of lost production. money. Referring to a double edged sword. so the company would never be able to stay in business long enough to impact their market segment. pharmaceutical drugs and products that impact human safety – the cost could be immeasurable…with the possibility of death among the results. document control procedures. a training program. then it is assumed that to have a quality calibration program. a comprehensive calibration management software package. there can be no repeatability. traceability or documentation. what are the responsibilities of a quality calibration department and also those of their customer? A calibration/metrology department should be responsible for: • Listening to their customers to understand their requirements and needs 53 . calibration interval analysis. time. an out-oftolerance program and procedures. Then you can say you have a quality calibration program. The question that should be asked is: “Do you have a quality calibration program that has traceable results to a national or international standard”? If the answer is yes. and reputation. But it doesn’t end there. Without calibration to a traceable standard (national. traceable documentation. or quantity. The basic belief is this – it is absolutely essential to have a quality calibration program in place to make a quality product. or intrinsic). you must also have all the parts needed to support traceable calibration: calibration procedures.a basic quality calibration program does it comply with all the requirements of the appropriate standard or regulation to which your company must conform? The other side of the double edged sword is having a calibration program in place without any type of quality. So is there cost and risk? Absolutely. This would equate to not having any type of calibration program at all. calibration records. continuous process improvements. no matter the size. shape. international. documented training for all your calibration technicians. and the ability to provide quality customer service in a timely manner. Therefore there can be no quality in the product.
Edition 1. 54 . EA-4/02. malfunctioning. 4. 2006. or in need of calibration As Lord Kelvin was quoted as saying.3-2006. RP-6.” 1. Milwaukee: ASQ Quality Press. CO. Jay L. 2. November 1995. 2007. ANSI/NCSL Z540. Boulder. 1999. you cannot improve it. Traceability of Measurement. The Quality Calibration Handbook. NCSL International. Expression of the Uncertainty of Measurement in Calibration. “If you cannot measure it. CO. December 1999 rev00. EAL-G12. 3. 5. Bucher. contaminating or damaging it under normal operating conditions • Using their work order system for requesting service when equipment is broken.a basic quality calibration program • Translating those requirements to the accuracy and specifications of the test equipment and support services that meet or exceed their quality expectations • Delivering test equipment that consistently meets requirements for reliable performance • Providing knowledgeable and comprehensive test equipment support • Continuously reviewing and improving their services and processes Your customers should be responsible for: • Informing Metrology of their requirements and needs • Getting the proper training in the correct and safe usage of test equipment • Maintaining their test equipment without abusing. Calibration Control Systems for the Biomedical and Pharmaceutical Industry. NCSL. Boulder.
Does this mean that the electricians and instrumentation people should be calibration experts? Not really. i. However. modern calibration techniques and calibration systems have made it easier to fulfill the requirements on instrumentation calibration and maintenance in a productive way. production processes and quality systems. Quality systems. What is calibration and why calibrate Calibration can brief ly be described as an activity where the instrument being tested is compared to a known reference value. but this topic should not be ignored. 1. To be able to answer the question why calibrate. Fortunately. some understanding of the techniques. put new and tight requirements on the accuracy of process instruments and on process control. i. The keywords here are ‘known reference’. traceable calibration certificate. calibrator. calibrator. we must first determine what measurement is and why measuring is necessary. repeatability. with regard to accuracy.e. confidence levels etc.traceable and efficient calibrations Traceable and efficient calibrations in the process industry T oday’s modern process plants.e. which means that the calibrator used should have a valid. 57 . Calibration can briefly be described as an activity where theinstrument being tested is compared to a known reference value. such as the ISO9000 and ISO14000 series of quality standards. uncertainty. call for systematic and well-documented calibrations. terminology and methods involved in calibration must be known and understood in order to perform according to International Quality Systems.
Note: the true value of a quantity is an ideal concept and.” What is then the value of quantity? According to the standards the true value of a quantity is: “The value which characterizes a quantity perfectly defined during the conditions which exist at the moment when the value is observed.” Therefore all instruments display false indications! A set of experimental operations for the purpose of determining the value of a quantity.traceable and efficient calibrations WHAT IS MEASUREMENT? In technical standards terms the word measurement has been defined as: “A set of experimental operations for the purpose of determining the value of a quantity. Departments House and working standards Process instrumentation 58 . it cannot be known. HIERARCHY OF ACCURACY TRUE VALUE International National standard Authorized Laboratories Instr. in general.
EVERYTHING IS BASED ON MEASUREMENTS PROCESS CONTROL SYSTEM MEASUREMENTS CONTROLS INSTRUMENTATION MEASUREMENTS ADJUSTMENTS Production Factors PROCESS Products 59 . energy. they drift and lose their ability to give accurate measurements.traceable and efficient calibrations 2. In practice. Why measure? The purpose of a process plant is to convert raw material. which must be done better than the competitors. the control cannot be better than the quality of measurements from the process. in other words. Anyhow. Why calibrate The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability. manpower and capital into products in the best possible way. The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability. optimization is done by means of process automation. 3. in other words. This conversion always involves optimizing. regardless of how advanced the process automation system is.
which produces uniform quality and minimizes the negative impacts on the environment. Other good reasons for calibration are: • To maintain the credibility of measurements • To maintain the quality of process instruments at a good-as-new level • Safety and environmental regulations • ISO9000. while another performs differently. Even instruments of the same manufacturer. other quality systems and regulations The ISO9000 and ISO14000 can assist in guiding regular. This drift makes recalibration necessary. QUALITY MAINTENANCE QUALITY QP C1 C2 C1–C7 CALIBRATIONS C3 C4 “GOOD AS NEW” C5 C6 C7 QM LOWER TOLERANCE Q1 Q2 Q3 QZM PURCHASE T1 T2 T3 TIME QP – PURCHASED QUALITY QZM – ZERO MAINTAINED QUALITY QM – MAINTAINED QUALITY 60 . Environment conditions. type and range can show varying performance. systematic calibrations. elapsed time and type of application can all affect the stability of an instrument. elapsed time and type of application can all affect the stability of an instrument. Environment conditions.traceable and efficient calibrations they drift and lose their ability to give accurate measurements. One unit can be found to have good stability.
maintenance and storage. to ensure valid results. When used in the monitoring and measurement of specified requirements. 5. Traceability is a declaration stating to which national standard a certain instrument has been compared. Note: See ISO 10012 for further information. Records of the calibration and verification results are then maintained. adjusted or re-adjusted as necessary. SI-UNITS International standards National standards Reference standards Working standards Process standards 61 . The organization establishes the processes for ensuring that measurements and monitoring are carried out and are carried out in a manner consistent with the monitoring and measurement requirements.traceable and efficient calibrations 4.1 ISO9001: 2008 The organization determines the monitoring and measurements to be performed. Regulatory requirements for calibration 5. protected from damage and deterioration during handling. This is done prior to initial use and reconfirmed as necessary. identified for the determining of the calibration status. the basis used for calibration or verification is recorded. If no such standards exist. In addition. Where necessary. Traceability Calibrations must be traceable. the ability of computer software to satisfy the intended application is confirmed. The organization then takes appropriate action on the equipment and any product affected. as well as the measuring devices needed to provide evidence of a product’s conformity to determined standards. measuring equipment is calibrated or verified with measurement standards traceable to national or international standards at specified intervals. the organization assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. safeguarded against adjustments that would invalidate the measurement result.
• All of the above should be implemented in conjunction with following regulations: – 21 CFR Part 211 – “Current Good Manufacturing Practice for Finished Pharmaceuticals” – 21 CFR Part 11 – “Electronic Records. Audit Trail. • All instrumentation should have a unique ID. Audit Trail. process and safety instruments should be physically tagged.S. User Management. • Documented change management system must be in place. U. • Calibration standards must be more accurate than the required accuracy of the equipment being calibrated. Electronic Signatures” Software systems need features such as Electronic Signature. Users must understand their responsibilities once they give an electronic signature. In such a system. • There must be documented evidence that personnel involved in the calibration process have been trained and are competent. Software systems need features such as Electronic Signature. User Management. • All instruments used must be fit for purpose. edit. the Electronic Signature is considered equivalent to a hand-written signature. • Calibration standards should be traceable to national and international standards. Food and Drug Administration) Any pharmaceutical company that sells their products in the USA must comply with FDA regulations. and Security System to be able to comply with these regulations. regardless of where the products are manufactured. • All electronic systems must comply with FDA’s 21 CFR Part 11. and Security System to be able to comply with these regulations. • Calibration records must be maintained. An Audit Trail is required to support change management. which add. • A calibration period and error limits should be defined for each instrument.2 PHARMACEUTICAL (FDA. all product. 62 .traceable and efficient calibrations 5. • There should be a record of the history of each instrument. Audit Trails should record all modifications. • Calibrations must be done in accordance with written. or delete data from an electronic record. approved procedures.
Non-linearity is specified by the Terminal Based method or the Best Fit Straight Line method. regardless of where the products are manufactured. 63 . The requirements for EU GMPs are similar to those of the US FDA. Please note that the definitions listed here are simplified. Non-linearity Non-linearity is the maximum deviation of a transducer’s output from a defined straight line. Quite a few of the following terms are also used on specification sheets for calibrators. Validation Validation of measurement and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use. including Annex 11. DEFINITIONS OF METROLOGICAL TERMS Some metrological terms in association with the concept of calibration are described in this section. as described in Section 5. Validation of measure ment and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use. 6.2.traceable and efficient calibrations 5. Calibration An unknown measured signal is compared to a known reference signal.3 PHARMACEUTICAL (EU GMPs) Any pharmaceutical company that sells their products in the European Union must comply with EU GMPs. Resolution Resolution is the smallest interval that can be read between two readings.
Accuracy is usually expressed % F. . under normal operating conditions. are included in the accuracy figures provided. Drift is usually given as a typical value.S. stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. Hysteresis The deviation in output at any point within the instrument’s sensing range. or % of RDG + adder. Repeatability is often expressed in the form of standard deviation. 64 Stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. The difference between these two expressions is great. usually 90 days to 12 months. / °C or % of RDG/ °C. which can be detected as an output. and then with decreasing values. hysteresis. Accuracy Generally accuracy figures state the closeness of a measured value to a known reference value. temperature effects etc. The accuracy of the reference value is generally not included in the figures.S. Good resolution is required in order to detect sensitivity. Temperature coefficient The change in a calibrator’s accuracy caused by changes in ambient temperature (deviation from reference conditions). when first approaching this point with increasing values. The only way to compare accuracy presented in different ways is to calculate the total error at certain points. It must also be checked if errors like non-linearity. usually 90 days to 12 months. Stability Often referred to as drift.traceable and efficient calibrations Sensitivity Sensitivity is the smallest variation in input. The temperature coefficient is usually expressed as % F. under normal operating conditions. Repeatability Repeatability is the capability of an instrument to give the same output among repeated inputs of the same value over a period of time.
there will be an observable difference in the values measured.traceable and efficient calibrations Uncertainty Uncertainty is an estimate of the limits. Type A involves the statistical analysis of a series of measurements. is used for calculation. Type A uncertainty The type A method of calculation can be applied when several independent measurements have been made under the same conditions. 65 . If there is sufficient resolution in the measurement. at a given cover factor (or confidence level). or the use of inappropriate technology. which can vary in magnitude and in sign. Type B. in general. Values belonging to this category may be derived from: It should be noted that. The other group of components.e. Standard deviation is used as a measure of the dispersion of values. It should be noted that. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. ambient conditions. set-up of the measuring. in general. In this case. which contain the true value. often called the “root-mean-square repeatability error”. Examples of such errors include: errors in recording data. etc. in an unpredictable manner. Systematic errors or effects remain constant during the measurement. could be said to be of a systematic nature. rather than applying statistical analysis of a series of measurements. The standard deviation. It involves the evaluation of uncertainty using scientific judgement based on all available information concerning the possible variables. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. for a series of measurements under the same conditions. Examples of systematic effects include errors in reference value. uncertainty is calculated using Type A uncertainties. Type B uncertainty Type B evaluation of uncertainty involves the use of other means to calculate uncertainty. the effects of these components include measurement errors. i. Uncertainty is evaluated according to either a “Type A” or a “Type B” method. Type B uncertainty is used when the uncertainty of a single measurement is expressed. errors in calculation.
g. In cases where normal (Gaussian) distribution can be assumed. The maintenance management system may alert when calibration is 66 . 7. It is a skill that can be learnt with practice. A well-based Type B evaluation of uncertainty can be as reliable as a Type A evaluation of uncertainty. in ISO9001: 2008.traceable and efficient calibrations • Experience with or general knowledge of the behavior and properties of relevant materials and instruments • Ambient temperature • Humidity • Local gravity • Atmospheric pressure • Uncertainty of the calibration standard • Calibration procedures • Method used to register calibration results • Method to process calibration results The proper use of the available information calls for insight based on experience and general knowledge. there must be a clear statement of cover probability or confidence level. should be used. there must be a clear statement of cover probability or confidence level. CALIBRATION MANAGEMENT Many companies do not pay enough attention to calibration management although it is a requirement e. k=2. The expanded uncertainty corresponds to a coverage probability (or confidence level) of approximately 95%. For uncertainty specifications. especially in a measurement situation where a Type A evaluation is based only on a comparatively small number of statistically independent measurements. the standard coverage factor. Usually one of the following confidence levels are used: 1 s = 68% 2 s = 95% 3 s = 99% For uncertainty specifications. Expanded uncertainty The EA has decided that calibration laboratories accredited by members of the EA shall state an expanded uncertainty of measurement obtained by multiplying the uncertainty by a coverage factor k.
The instrument’s measurement ranges and error limits are defined in the software and also downloaded to the calibrator. If something is documented. the software automatically detects the calibrator that was used. Depending on what process variable is calibrated and how many calibration points are recorded. Calibration records. no printed notes. are needed. The increase in work productivity allows for more calibrations to be carried out within the same period of time as before. finding the sheets requires a lot of effort. Modern calibration management software can be a tool that automates and simplifies calibration work at all levels. using automated tools can be 5 to 10 times faster compared to manual recording. The “As Found” and “As Left” are saved in the calibrator’s memory. it is usually in the form of a hand-written sheet that is then archived. There is no need to make tricky calculations manually in the field. While the calibration results are uploaded onto the database. Thus the calibrator is able to detect if the calibration was passed or failed immediately after the last calibration point was recorded. It automatically creates a list of instruments waiting to be calibrated in the near future. and the traceability chain is documented without requiring any further actions from the user. Unfortunately. An efficient calibration management system consists of calibration management software and documenting calibrators. When the technician is about to calibrate an instrument. including the full calibration history of an The instrument’s measurement ranges and error limits are defined in the software and also downloaded to the calibrator. (s)he simply downloads the instrument details from the calibration management software into the memory of a documenting calibrator. 67 . If the software is able to interface with other systems the scheduling of calibrations can be done in the maintenance system from which the work orders can be automatically loaded into the calibration management software. If the calibration results need to be examined at a later time. etc. Once the job has been done. and there is no need to write down anything with pen.traceable and efficient calibrations needed and then opens up a work order. effort and money. what happens between opening and closing of the work order is not documented very often. Choosing professional tools for maintaining calibration records and doing the calibrations can save a lot of time. the work order will close and the maintenance system will be satisfied. All this saves an extensive amount of time and prevents the user from making mistakes.
and they can be even used for configuring these “smart” transmitters. If paper copies of certificates are preferred. are kept in the database. of course. When an instrument has been calibrated several times. When all calibration related data is located in a single database the software is obviously able to create calibration related reports and documents. Although there is a lot of data involved. printing them must. One of today’s trends is to move towards to a paperless office. Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. In addition to the conventional mA output of a transmitter. the system is easy to learn and use.traceable and efficient calibrations Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. Transferring to a new calibration system may sound like a huge task and it can be a huge task. modern calibrators can also read HART. If a calibrator drifts out of its specifications. instrument. it is possible to use a “reverse traceability report” to get a list of instruments that have been calibrated with that calibrator. it is possible to manage calibration records on computer without producing any papers. QA will find a calibration management system useful. The requested calibration records can be viewed on screen with a couple mouse clicks. temperature and electrical signals including frequency and pulses. Foundation Fieldbus or Profibus output of the transmitters. 68 . It is not very uncommon to have a calibrator that calibrates pressure. Today’s documenting calibrators are capable of calibrating many process signals. which assists in determining whether or not the calibration period should be changed. For instance the maintenance manager can use it as a calibration planning and decision-making tool for tracking and managing all calibration related activities. If the system manufacturer has paid attention usability. it does not mean the job is an enormous one. Good calibration tools help technicians work more efficiently and accurately. When many tasks are automated. be possible. therefore accessing previous results is also possible in just a few seconds. software displays the “History Trend”. There are probably thousands of instruments that need to be entered into the database and all the details must be checked and verified before the system is up and running. When an auditor comes for a visit. If the calibration management software includes the right tools. the users can concentrate on their primary job.
It assists in documenting. References  ISO9001: 2008 “Quality Management Systems.traceable and efficient calibrations Nowadays most companies have instrumentation data in some type of electronic format: as Excel spreadsheets. The vendor of the calibration system is most likely able to import most of the existing data to the calibration database saving months of work. Maintenance databases. Electronic Signatures”  21 CFR Part 211: “Current Good Manufacturing Practice for Finished Pharmaceuticals” A good. scheduling. etc. more accurately and with better results than what could be reached with a manual system. Requirements”  21 CFR Part 11: “Electronic Records. automated calibration system reduces workload. planning. 69 . CONCLUSION A good. analyzing and finally optimizing the calibration work. automated calibration system reduces workload because it carries out tasks faster.
Calibration Management and Maintenance
Why Calibrate? What is the risk of not calibrating?
alibration can be briefly described as an activity where the instrument being tested is compared to a known reference value. At the simplest level, calibration is a comparison between measurements – one of known magnitude or correctness made or set with one device, and another measurement made in as similar a way as possible with a second device. The device with the known or assigned correctness is called the standard. The second device is the unit under test or test instrument. Calibration is often required with a new instrument or when a specified time period or a specified number of operating hours has elapsed. In addition, calibration is usually carried out when an instrument has been subjected to an unexpected shock or vibration that may have put it out of its specified limits. Calibration in industrial applications When a sensor or instrument experiences temperature variations or physical stress over time, its performance will invariably begin to decline, which is known as ‘drift’. This means that measurement data from the sensor becomes unreliable and could even affect the quality of a company’s production. Although drift cannot be completely eliminated, it can be discovered and rectified via calibration. The purpose of calibration is to determine how accurate an instrument or sensor is. Although most instruments provide high accuracy these days, regulatory bodies often need to know just how inaccurate a particular instrument is and whether it drifts in and out of specified tolerance over time.
Although drift cannot be completely eliminated, it can be discovered and rectified via calibration.
chemical and pharmaceutical industries. It is therefore critical that all instruments are calibrated at appropriate intervals. calibration has costs associated with it and in uncertain economic times. neglecting calibration can lead to unscheduled production or machine downtime. energy. this may even lead to a company losing its license to operate due to company not meeting its regulatory requirements. also need to calibrate their weighing instruments. This is particularly true for the food and beverage sector and for pharmaceutical manufacturers. who invoice customers based on the mass of what they supply (fiscal metering). product and process quality issues or even product recalls and rework. this activity can often become neglected or the interval between calibration checks on instruments can be extended in order to cut costs or simply through a lack of resources or manpower. Invoicing in these industries is often based on process measurements. harbors and retail outlets. power. However. Determining the correct mass of a product or material is particularly important for companies that supply steel. In certain situations. aviation companies. paper and pulp. Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. oil and gas. . Why is calibration important? Calibration ensures that instrument drift is minimized. Weighing instruments also need to be calibrated regularly.why calibrate The costs and risks of not calibrating Unfortunately. Product manufacturing also depends on accurate masses and so laboratories and production departments in the food and beverage. Furthermore. These companies need to prove not only that the mass is accurate but also that the equipment producing the readings was correctly calibrated. Fluctuating temperatures. The stability of an instrument very much depends on its application and the environment it operates in. Similarly. harsh 74 Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. if the instrument is critical to a process or is located in a hazardous area. allowing that sensor to drift over time could potentially result in a risk to employee safety. There is therefore a growing need to have the metrological quality of these weighing instruments confirmed by calibration. an end product manufactured by a plant with poorly calibrated instruments could present a risk to both consumers and customers.
6%.” Pharmaceutical manufacturers must follow current Good Manufacturing Practices. Even instruments manufactured by the same supplier can vary in their performance over time. For example. ISO 9002 and ISO 14001 require systematic. by improving the measurement of reactor power parameters from 2% to 0. the quality of the beer is a number one priority. This affects all process manufacturers. enabled the reactor power in each unit to be increased by 1. requires that calibration records are maintained and calibrations have to be carried out in accordance with written. instrument calibration can help to optimize a company’s production process or to increase the plant’s production capacity. The role of calibration is very important to ensure the quality and safety of the processes. Safety is another important reason to calibrate instruments. each instrument has a master history record and a unique ID. energy and utilities industries. In the power generation. a calibration interval and error limits should be defined for each instrument and standards should be traceable to national and international standards. Incorrect measurements in a hazardous area could lead to serious consequences. Calibration also ensures that product or batch quality remains high and consistent over time. He comments: “For Heineken. Quality systems such as ISO 9001. Furthermore. 75 . uncertainty and confidence levels. GMP. We must therefore ensure that all processes correspond to the planned characteristics. process and safety instruments should also be physically tagged. All product.why calibrate manufacturing conditions (dust and dirt) and elapsed time are all contributing factors here. Armando Rivero Rubalcaba is head of Instrumentation at beer producer Heineken (Spain). On the people side. approved procedures. there must be documented evidence that employees involved in the calibration process have been properly trained and competent. Production environments are potentially high risk areas for employees and can involve high temperatures and high pressures. Typically. The company must also have a documented change management system in place. with all electronic systems complying with FDA regulations 21 CFR Part 11. All the plants in Spain have received ISO 9001 and ISO 14001 certifications. repeatability. which has a significant effect on annual production capacity.4%. at the Almaraz Nuclear Power Plant in Spain. The role of calibration is very important to ensure the quality and safety of the processes. in addition to the BRC certificate of food safety. Standards must also be more accurate than the required accuracy of the equipment being calibrated. well-documented calibrations with respect to accuracy.
As Jacek Midera. especially from the viewpoint of production safety and quality of the final product.why calibrate Calibration is of great importance. gas conversion devices must be extremely accurate in measuring delivered gas. This is particularly true if sales invoicing is based on accurate process measurements. Instrument Maintenance Engineer at Shell (Netherlands) explains: “Until recently. calibration was mainly driven by economic motives: even the smallest of errors in delivery quantities are unacceptable in Shell’s operation due to the vast sums of money 76 . Therefore. Proper invoicing is therefore critical to energy and utilities companies. Customers want to pay for the exact amount of gas they’ve received. Similarly.” Today. Measuring instruments that yield wrong values could easily ruin the final product. controlling emissions is another critical factor for many process manufacturers. accurate measurements ensure proper billing. this figure rises dramatically to more than 4 million US dollars per year. As he puts it: “Calibration is of great importance. Preparation of the right rubber mixture is precision work and a sample is taken from each rubber mixture to ensure quality. including sensors used for measuring CO2 and NOX emissions. particularly in the oil and gas. This means that requirements for the calibrators are especially high. Heikki Karhe is a measurement technician at the tyre manufacturer Nokian Tyres. Calibrating instruments can help to make combustion more efficient in industrial ovens and furnaces. The latest Government regulations relating to carbon emissions may also require that companies calibrate specific instruments on a regular basis.” Neglecting to calibrate process instruments can also affect a company’s bottom line profits. according to recent research by Nielsen Research/ ATS Studies. measurement specialist at Mazovian Gas Company states: “Most importantly. manufacturers of food and beverage or pharmaceutical products could put their customers’ lives at risk by neglecting to calibrate their process instruments. petrochemicals and chemicals sectors. The factory is also full of pressure instruments and so it is also important for the safety of the workers that those instruments show the right values.7 million US dollars every year. especially from the viewpoint of production safety and quality of the final product. Indeed. As Ed de Jong. poor quality calibration is on average costing manufacturers more than 1. weighing scales or gas conversion devices. When only large companies with revenues of more than 1 billion US dollars are considered. The impact of even a small measurement error can be tremendous in terms of lost revenue. for example.
” Common misconceptions There are some common misconceptions when it comes to instrument calibration. Just because a sensor is newly installed does not mean that it will perform within the required specifications. For example. The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. some manufacturers claim that they do not need to calibrate their fieldbus instruments because they are digital and so are always accurate and correct. Quality standards may also dictate how often a pressure or temperature sensor needs calibrating. How often they are calibrated depends on a number of factors. for example. The main difference between fieldbus and conventional transmitters is that the output signal is a fully digital fieldbus signal. as well as begin to monitor the stability or drift of the instrument over time. This is simply not true. When to calibrate Due to drift. calibration has an important role especially for the license to operate. The optimal calibration interval for different instruments can only be determined with software-based history trend analysis. In this way. Another common misunderstanding is that new instruments do not require calibration. This interval may be decreased if the instrument is being used in a critical process or application. 77 . Changing the output signal does not change the need for periodic calibration. Government regulations demand that specific instruments must be calibrated. highly stable sensors are not calibrated as often as those sensors that are more susceptible to drift. Nowadays.why calibrate involved for both customers and governments [fiscal metering]. Although fieldbus transmitters have been improved in terms of their measurement accuracy when compared to analogue transmitters. Again. the manufacturer of the instrument will provide a recommended calibration interval. this is not true. a company is able to enter all the necessary instrument data to its calibration database or calibration management software. all instruments require calibrating at set intervals. First. this does not eliminate the need for calibration. By calibrating an instrument before installation. The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. instruments related to CO2 and NOX emissions.
and analysis. Decisions then need to be made regarding the calibration interval for each instrument. followed by the selection of suitable calibration methods and tools for execution of these methods. it is important to consider the typical calibration management tasks that companies have to undertake. comprising of planning and decision-making. Once this has been agreed. Careful planning and decision-making is important. Finally. the calibration range and required tolerances need to be identified. The creation and approval of standard operating procedures (SOPs) for each device is then required. with documentation being a critical part of this. But in order to understand how software can help process plants better manage their instrument calibrations. Calibration software is one such tool that can be used to support and guide calibration management activities. with documentation being a critical part of this. 79 .why use software for calibration management Why use software for calibration management? E very manufacturing plant has some sort of system in place for managing instrument calibration operations and data. different companies from a diverse range of industry sectors use very different methods of managing these calibrations. documentation. There are five main areas here. All plant instruments and measurement devices need to be listed. However. pressure transducers and weighing instruments – require regular calibration to ensure they are performing and measuring to specified tolerances. efficiency. Calibration software is one such tool that can be used to support and guide calibration management activities. organisation. Plant instrumentation devices such as temperature sensors. and accuracy of data and their level of automation. quality. the company must identify current calibration status for every instrument across the plant. execution. then classified into ‘critical’ and ‘non-critical’ devices. These methods differ greatly in terms of cost.
the consequences could be disastrous for the plant. including any associated safety procedures. The next calibration tasks then have to be scheduled. then classified into ‘critical’ and ‘non-critical’ devices. for example. Based on the calibration results. Documentation Documentation is a very important part of a calibration management process. which may then have to be scrapped. ISO 9001:2008 and the FDA both state that calibration records must be maintained and that calibration must be carried out according to written. service engineers. involves training the company’s calibration staff – typically maintenance technicians. companies then have to analyse the data to see if any corrective action needs to be taken. organisation. Staff carrying out these activities must follow the appropriate instructions before calibrating the device. Imagine how long and difficult a task this is if the plant has thousands of instruments that require calibrating on at least a sixmonthly basis? The amount of manual documentation increases almost exponentially! 80 . a safety problem or leading to batches of inferior quality goods being produced. The effectiveness of calibration needs to be reviewed and calibration intervals checked. resulting in costly production downtime. These intervals may need to be adjusted based on archived calibration history. process and quality engineers and managers – in using the chosen tools and how to follow the approved SOPs. The next stage. This means an instrument engineer can spend as much as 50 per cent of his or her time on documentation and paperwork – time that could be better spent on other value-added activities. The calibration is then executed according to the plan. approved procedures. making notes of calibration results in the field. The documentation and storage of calibration results typically involves signing and approving all calibration records that are generated. and documenting and archiving calibration data. The execution stage involves supervising the assigned calibration tasks. This paperwork typically involves preparing calibration instructions to help field engineers. although further instructions may need to be followed after calibration. If. calibration labels need to be created and pasted. Resources then have to be organised and assigned to actually carry out the scheduled calibration tasks.why use software for calibration management All plant instruments and measurement devices need to be listed. then created documents copied and archived. a sensor drifts out of its specification range.
just under a third of companies (with 500+ employees) typically have more than 5.000 calibrations per year. Many other companies said that they relied on generic spreadsheets and/or databases for this. Any type of paper-based calibration system will be prone to human error.000 calibrations each year. but many firms still do this. A significant proportion (almost 20 per cent) of those surveyed said they used a manual.000 instruments that require calibrating. many of these firms said they were doing it without any sort of calibration software to assist them. with 55 per cent of companies performing more than 2. However.why use software for calibration management When it comes to the volume of documentation required. Only a quarter of companies use calibration software In Beamex’s own Calibration Study carried out recently. In a recent survey conducted by Control Magazine. The percentage is still quite high in the food & beverage sector. paper-based system. The figures outlined appear to suggest that companies really do require some sort of software tool to help them manage their instrument calibration processes and all associated documentation. However. Noting down calibration results by hand in the field and then transferring these results into a spreadsheet back at the office may seem archaic. In the Power & Energy sector. for example. where 21 per cent of firms said they calibrated their instruments more than 2. Oil.000 times every year.000 calibrations each year. 81 . 42 per cent of companies perform more than 2. whilst others used a calibration module within an existing Computerised Maintenance Management System (CMMS). a mere 25 per cent of companies with 500+ employees (across the industry sectors mentioned above) said that they did use specialist calibration management software. a massive 75 per cent of companies carry out more than 2. The other 60 per cent of companies determined This means an instrument engineer can spend as much as 50 per cent of his or her time on documentation and paperwork – time that could be better spent on other value-added activities. This equates to a huge amount of paperwork for any process plant. In the highly regulated pharmaceuticals sector. different industry sectors have different requirements and regulations. Gas & Petrochemicals is similarly high. the picture in reality can be very different. Furthermore. 40 per cent of companies surveyed said that they calculated calibration intervals by using historical trend analysis – which is encouraging. let alone time consuming. analysis of paper-based systems and spreadsheets can be almost impossible.
Companies could save so much time and reduce costs by using calibration management software to analyse historical trends and calibration results. easier and more accurate analysis of calibration records and identifying historical trends. Typically. instrument calibration intervals based on either the manufacturer’s own recommendation. Rather than rely on the manufacturer’s recommendation for calibration intervals. paper-based system requires little or no 82 . Using software for calibration management enables faster. this might include engineers using pens and paper to record calibration results while out in the field. there seems to be some general challenges that companies face when it comes to calibration management. Just as important. While using a manual. The number of instruments and the total number of periodic calibrations that these devices require can be several thousand per year. or they used a uniform interval across the plant for all instruments. potentially explosive area of the manufacturing plant. every instrument calibration has to be documented and these documents need to be easily accessible for audit purposes. for improved safety. Instrument ‘drift’ can be monitored closely over a period of time and then decisions taken confidently with respect to amending the calibration interval. How to plan and keep track of each instrument’s calibration procedures means that planning and scheduling is important.why use software for calibration management Using software for calibration management enables faster. after which they are archived as paper documents. a process plant may find it necessary to increase the frequency of some sensors that are located in a hazardous. Regardless of industry sector. saving time and resources. the plant may be able to extend these intervals by looking closely at historical trends provided by calibration management software. Furthermore. easier and more accurate analysis of calibration records and identifying historical trends. by analysing the calibration history of a flow meter that is located in a ‘non-critical’ area of the plant. the company may be able to decrease the frequency of calibration. For example. On returning to the office. these notes are then tidied up or transferred to another paper document. Paper-based systems These systems typically involve hand-written documents. Neither method is ideal in practice. or by increasing the frequency where necessary. Plants can therefore reduce costs and optimise calibration intervals by reducing calibration frequency when this is possible.
The software manages and stores all instrument and calibration data. soaks up a lot of resources and typing errors are commonplace. such as the scheduling of tasks and entry of calibration results. Also. In these systems. Calibration software With specialist calibration management software. FDA) for managing calibration records.g. and Regardless of industry sector. certificates and labels. CMM systems are not designed to manage calibrations and so often only provide the minimum calibration functionality. production of reports. it is very labour-intensive and means that historical trend analysis becomes very difficult to carry out. In addition. the calibration data is not easily accessible. The data is stored in electronic format. there seems to be some general challenges that companies face when it comes to calibration management. Plant hierarchy and works orders can be stored in the CMM system. For example.why use software for calibration management investment. In addition. using an in-house legacy system to manage calibrations has its drawbacks.) Although certainly a step in the right direction. calibration data is typically entered manually into a spreadsheet or database. In-house legacy systems (spreadsheets. etc. users are provided with an easy-to-use Windows Explorer-like interface. but the calibration cannot be automated because the system is not able to communicate with ‘smart’ calibrators. the CMM system may not meet the regulatory requirements (e. but the recording of calibration information is still time-consuming and typing errors are common. Although instrument data can be stored and managed efficiently in the plant’s database. automatic alarms cannot be set up on instruments that are due for calibration. The system is time consuming. 83 . the calibration process itself cannot be automated. databases. Furthermore. This includes the planning and scheduling of calibration work. analysis and optimisation of calibration frequency. Dual effort and re-keying of calibration data are also significant costs here. Calibration module of a CMMS Many plants have already invested in a Computerised Maintenance Management (CMM) system and so continue to use this for calibration management. communication with smart calibrators. the level of automation is still low.
easier and more accurate analysis of calibration records and identifying historical trends. The software generates reports automatically and all calibration data is stored in one database rather than multiple disparate systems. Execution is more efficient and errors are eliminated. such as Change Management. then automatically uploaded back to the calibration software. enabling engineers to optimise calibration intervals using the software’s History Trend function. device and calibrator databases are maintained. Using software-based calibration management systems in conjunction with documenting calibrators means that calibration results can be stored in the calibrator’s memory. Analysis becomes easier too. plant productivity and efficiency. Calibration software has many functions that help in meeting these requirements. Audit Trail and Electronic Signature functions. while automatic alerts for scheduled calibrations can be set up. which improves quality. Also. planning and decisionmaking are improved. automated calibration process. Using software for calibration management enables faster. Regulatory organisations and standards such as FDA and ISO place demanding requirements on the recording of calibration data. reports and labels can all be printed out on paper or sent in electronic format. Procedures and calibration strategies can be planned and all calibration assets managed by the software. calibration software can facilitate both the preparation and the audit itself. when a plant is being audited. These instructions can also be downloaded to a technician’s handheld documenting calibrator while they are in the field.why use software for calibration management easy integration with CMM systems such as SAP and Maximo. Human error is minimised and engineers are freed up to perform more strategic analysis or other important activities. There is no re-keying of calibration results from a notebook to a database or spreadsheet. The Change Management feature in Beamex’s CMX software. Organisation also improves. Calibration certificates. Position. Calibration instructions are created using the software to guide engineers through the calibration process. complies with FDA requirements. Locating records and verifying that the system works is effortless when compared to traditional calibration record keeping. The result is a streamlined. 84 . Benefits of using calibration software With software-based calibration management. for example. The system no longer requires pens and paper. Documentation is also improved.
For relatively small plants. a central calibration management database is often implemented that is used by multiple plants across the world. Engineers can analyse calibration results to see whether the calibration intervals on plant instruments can be altered. implementing software-based calibration management means overall costs will be reduced. which is particularly beneficial if the company is replacing a lot of labour-intensive calibration activities. Benefits for all process plants Beamex’s suite of calibration management software can benefit all sizes of process plant. Beamex’s high-end solution. For example. multilingual users and a very large amount of instruments that require calibration. Beamex CMX Professional is ideal. reduce costs and increase productivity by preventing unnecessary double effort and re-keying of works orders in multiple systems. with no manual documentation procedures. Costly production downtime will also be reduced. Here. as the entire calibration process is now streamlined and automated. calibration management software can be easily integrated to this system. Even if a plant has already implemented a CMM system. Integration also enables the plant to automate its calibration management with smart calibrators. The integration will save time. only a few instruments require calibrating and where regulatory compliance is minimal. If the plant instruments are already defined on a database. These savings come from the now-paperless calibration process. CHECKLIST Choosing the right calibration software • Is it easy to use? • What are the specific requirements in terms of functionality? • Are there any IT requirements or restrictions for choosing the software? • Does the calibration software need to be integrated with the plant’s existing systems? • Is communication with smart calibrators a requirement? • Does the supplier offer training. Plant efficiencies should also improve. support and upgrades? • Does the calibration software need to be scalable? • Can data be imported to the software from the plant’s current systems? • Does the software offer regulatory compliance? • Supplier’s references and experience as a software developer? 85 . validated processes. is suitable for process manufacturers with multiple global sites. implementation. Beamex CMX Light is the most appropriate software.Business benefits For the business. as well as strict regulatory compliance. the calibration management software can utilise the records available in the CMM system database. For medium-to-large sized companies that have multiple users who have to deal with a large amount of instruments and calibration work. those instruments that perform better than expected may well justify a reduction in their calibration frequency. Manual procedures are replaced with automated. which simply is not possible with a standalone CMM system. CMX Enterprise. where calibration data is needed for only one location.
can benefit from implementing specialist calibration management software. Despite these benefits. Compared to traditional. regardless of industry sector. across all industry sectors. Summary Every type of process plant. paper-based systems. in-house built legacy calibration systems or calibration modules with CMM systems. The results showed that 82% of CMX Calibration software customers said that using Beamex products had resulted in cost savings in some part of their operations. The business benefits of using software for calibration management • Cost reduction • Quality improvements • Increase in efficiency 86 . using dedicated calibration management software results in improved quality. only one quarter of companies who need to manage instrument calibrations actually use software designed for that purpose.why use software for calibration management SUMMARY Calibration software improves calibration management tasks in all these areas • Planning & decision-making • Organisation • Execution • Documentation • Analysis Beamex users Beamex conducted recently a survey of its customers. whilst 92% said that using CMX had improved the quality of their calibration system. increased productivity and reduced costs of the entire calibration process. 94% of CMX users stated that using Beamex products had improved the efficiency of their calibration processes.
a plant is able to define which instruments can be calibrated less frequently and which should be calibrated more frequently. resulting in costly production downtime. which then have to be scrapped. If sensors drift out of their specification range. Calibration history trend analysis is only possible with calibration software that provides this functionality. 89 . with increasing demands and cost issues being placed on manufacturers these days. However. which ensures that all instruments used across the site are calibrated at the appropriate times. the time and resources required to carry out these calibration checks are often scarce. safety issues or possibly leading to batches of inferior quality goods being produced. but for other sensors that are deemed less critical to production. a function available within Beamex® CMX calibration software. This can sometimes lead to instruments being prioritised for calibration. pressure transducers. Plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’. Most process manufacturing plants will have some sort of maintenance plan or schedule in place. being calibrated less frequently or not at all. By doing it. flow meters and the like – are performing and measuring to specified tolerances.how often should instruments be calibrated How often should instruments be calibrated P lants can improve their efficiency and reduce costs by performing calibration history trend analysis. Adjusting calibration intervals based on history trend analysis Manufacturing plants need to be absolutely confident that their instrumentation products – temperature sensors. with those deemed critical enough receiving the required regular checks. the consequences can be disastrous for a plant.
the survey showed that from all industry sectors. Second. 59% said they calibrated once a year and 30% said they calibrated twice a year. manufacturing. the plant can analyze whether it should increase or decrease the calibration frequency for all its instruments. Cost savings can be achieved in several ways. how often do process plants actually calibrate their instruments and how does a maintenance manager or engineer know how often to calibrate a particular sensor? In March 2010. But plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’. in the pharmaceuticals sector. The analyses of historical trends and how a pressure sensor. a function available within Beamex® CMX calibration software. oil and gas. the study proved also that the pharmaceuticals sector typically possesses a significantly higher number of instruments per plant that require calibrating. paper and pulp. Interestingly. First. This type of practise is common in companies that employ an effective ‘Preventive Maintenance’ regime. for example.how often should instruments be calibrated Sensors that are found to be highly stable do not need to be re-calibrated as often as sensors that tend to drift. power and energy. ensuring that instruments are checked and corrected before they drift out of tolerance. is only possible with calibration software that provides this type of functionality. food and beverage. by calibrating instruments more often when they are located in critical areas of the plant. With this function. due to it being a highly regulated industry. drifts in and out of tolerance over a given time period. The survey covered all industry sectors. Beamex conducted a survey that asked process manufacturing companies how many instruments in their plant required calibrating and the frequency with which these instruments had to be calibrated. However. by calibrating less frequently where instruments appear to be highly stable according to their calibration history. including pharmaceuticals. 56% of the respondents said they calibrated their instruments no more than once a year. service. In addition. Current practices in process plants But in reality. chemicals. Perhaps unsurprisingly. these plants also calibrate their instruments more frequently than other industry sectors. 90 .
says Mäki. Doing this. without of course sacrificing the quality of the product or process or the safety of the plant and its employees. Calibration software such as CMX can also help with the planning of calibration operations. the historical trend) companies can reduce costs and improve their efficiencies. Sensors that are found to be highly stable do not need to be re-calibrated as often as sensors that tend to drift. in setting up a new process line for example. which helps companies identify the optimal calibration intervals for instruments. As Mäki explains: “When an engineer buys a particular sensor. Pertti Mäki is Area Sales Manager at Beamex. the engineer now has data to present to the supplier to support his findings. he says. or even years of operation and which can be left for longer periods. enables maintenance staff to concentrate their efforts only where they are needed. actually performed within the specified tolerance over a certain time period. the supplier provides a technical specification that includes details on what the maximum drift of that sensor should be over a given time period. Calibration schedules take into account the accuracy required for a particular sensor and the length of time during which it has previously been able to maintain that degree of accuracy. If it hasn’t. But there are other. The function enables users to plan the optimal calibration intervals for their instruments.how often should instruments be calibrated The benefits of analyzing calibration history trends But regardless of the industry sector. therefore eliminating unnecessary calibration effort and time. perhaps less obvious benefits of looking at the historical drift over time of a particular sensor or set of measuring instruments. This makes it an invaluable tool for maintenance or quality personnel who. 91 .” The trick.” But that’s not all. He comments: “The largest savings from using the History Trend Option are in the pharmaceuticals sector. without doubt. He specialises in selling the Beamex® CMX to different customers across all industry sectors. The History Trend function also means that a plant can now compare the quality or performance of different sensors from multiple manufacturers in a given location or set of process conditions. weeks. by analysing an instrument’s drift over time (ie. can use the functionality to compare different sensor types to see which one best suits the new process. is determining which sensors should be recalibrated after a few days. the engineer can now verify that the sensor he or she has purchased. but all industry sectors can benefit from using the software tool. With CMX’s History Trend Option.
Based on this information. the user can get an overview of how a particular device drifts between calibrations and also whether the drift increases with time. The History Trend function enables users to plan the optimal calibration intervals for their instruments. can analyze an instrument’s drift over a certain time period. for example. it is then possible to make decisions and conclusions regarding the optimal calibration interval and the quality of the instruments with respect to measurement performance. The ‘History Trend’ window enables users to view key figures of several calibration events simultaneously. using the ‘Report Design’ tool option. 92 . Reporting is straightforward and the user can even tailor the reports to suit his or her individual needs. Also. For example. the engineer can analyze how different devices are suited for use in a particular area of the plant or process. History Trend displays the instrument’s drift over a given period both numerically and graphically. allowing to evaluate the calibrations of a position or a device for a longer time period compared to the normal calibration result view. maintenance personnel. Once implemented.how often should instruments be calibrated History Trend displays the instrument’s drift over a given period both numerically and graphically.
This helps in comparing differences between devices. HISTORY TREND REPORT HISTORY TREND USER-INTERFACE The graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments. • The Beamex® CMX stores every calibration event into the database.how often should instruments be calibrated CALIBRATION HISTORY TREND ANALYSIS Calibration history trend analysis allows you to analyze the instrument’s drift over a certain time period. the history trend is made automatically without any extra manual work. • The graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments. 93 . • The Beamex® CMX also indicates when new devices have been installed and calibrated.
manual methods • Enables engineers to check that the instruments they have purchased for the plant are performing to their technical specifications and are not drifting out of tolerance regularly • Supplier evaluation: the performance and quality of different sensors from different manufacturers can be compared quickly and easily.how often should instruments be calibrated SUMMARY The benefits of calibration history trend analysis: • Analyzing and determining the optimal calibration interval for instruments • Conclusions can be made regarding the quality of a particular measuring instrument • Time savings: faster analyses is possible when compared to traditional. When calibration frequency can be decreased: • If the instrument has performed to specification and the drift has been insignificant compared to its specified tolerance • If the instrument is deemed to be non-critical or in a low priority location When calibration frequency should be increased: • If the sensor has drifted outside of its specified tolerances during a given time period • If the sensor is located in a critical process or area of the plant and has drifted significantly compared to its specified tolerance over a given time period • When measuring a sensor that is located in an area of the plant that has high economic importance for the plant • Where costly production downtime may occur as a result of a ‘faulty’ sensor • Where a false measurement from a sensor could lead to inferior quality batches or a safety issue 94 .
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. or prior to use. In addition. When used in the monitoring and measurement of specified requirements. against measurement standards traceable to international or national measurement standards. the basis used for calibration or verification shall be recorded. e) be protected from damage and deterioration during handling. Where necessary to ensure valid results. measuring equipment shall a) be calibrated or verified at specified intervals. where no such standards exist. maintenance and storage.4). d) be safeguarded from adjustments that would invalidate the measurement result. b) be adjusted or re-adjusted as necessary. the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. This shall be undertaken prior to initial use and reconfirmed as necessary.2.6 Control of monitoring and measuring devices The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.how often should instruments be calibrated ISO 9001:2008 quality management requirements 7. the ability of computer software to satisfy the intended application shall be confirmed. c) be identified to enable the calibration status to be determined. 95 . The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.
how often should calibrators be calibrated
How often should calibrators be calibrated
s a general rule for Beamex’s documenting MC calibrators, starting with a 1-year calibration period is recommended, because the calibrators has a 1-year uncertainty specified. The calibration period can be changed in the future, once you begin receiving cumulated stability history, which is then compared to the uncertainty requirements. In any case, there are many issues to be considered when deciding a calibrator’s calibration period, or the calibration period for any type of measuring device. This article discusses some of the things to be considered when determining the calibration period, and provides some general guidelines for making this decision. The guidelines that apply to a calibrator, also apply to other measuring equipment in the traceability chain. These guidelines can also be used for process instrumentation. An important aspect to consider when maintaining a traceable calibration system is to determine how often the calibration equipment should be recalibrated. International standards (such as ISO9000, ISO10012, ISO17025, CFRs by FDA, GMP, etc.) require the use of documented calibration programs. This means that measuring equipment should be calibrated traceably at appropriate intervals and that the basis for the calibration intervals should be evaluated and documented. When determining an appropriate calibration period for any measuring equipment, there are several things to be considered. They are discussed below.
Uncertainty need is one of the most important things to consider when determining the calibration period.
how often should calibrators be calibrated
Uncertainty need One of the first things to evaluate is the uncertainty need of the customer for their particular measurement device. Actually, the initial selection of the measurement device should be also done based on this evaluation. Uncertainty need is one of the most important things to consider when determining the calibration period. Stability history
In critical applications, the costs of an outof-tolerance situation can be extremely high (e.g. pharmaceutical applications) and therefore calibrating the equipment more often is safer.
When the customer has evaluated his/her needs and purchased suitable measuring equipment, (s)he should monitor the stability history of the measuring equipment. The stability history is important criteria when deciding upon any changes in the calibration period. Comparing the stability history of measuring equipment to the specified limits and uncertainty needs provides a feasible tool for evaluating the calibration period. Naturally, calibration management software with the history analysis option is a great help in making this type of analysis. The cost of recalibration vs. consequences of an out-of-tolerance situation Optimizing between recalibration costs and the consequences of an outof-tolerance situation is important. In critical applications, the costs of an out-of-tolerance situation can be extremely high (e.g. pharmaceutical applications) and therefore calibrating the equipment more often is safer. However, in some non-critical applications, where the out-oftolerance consequences are not serious, calibration can be made less frequently. Therefore, evaluating of the consequences of an out-oftolerance situation is something to be considered. The corrective actions in such a case should also be made into an operating procedure. Some measurements in a factory typically have more effect on a product quality than others, and therefore some measurements are more acute than others and should be also calibrated more often than others. Initial calibration period When you purchase calibration equipment with which you are not familiar, you still need to decide the initial calibration period. In this
how often should calibrators be calibrated
situation, abiding by the manufacturer’s recommendation is best. For more acute applications, using a shorter calibration period right from the beginning is recommended. Other things to be considered There are also other issues to be considered when determining the calibration period, such as the workload of the equipment, the conditions where the equipment will be used, the amount of transportation and is the equipment look damaged. In some cases, crosschecking with other similar measuring equipment is also feasible for detecting the need for calibration. Crosschecking may be carried out before every measurement in some acute applications. Naturally, only appropriate, metrological, responsible personnel in the company may make changes to the calibration equipment’s calibration period.
In some cases, crosschecking with other similar measuring equipment is also feasible for detecting the need for calibration.
The main issues to be considered when determining the calibration period for measuring equipment should include at least following: • The uncertainty needs of the measurements to be done. • The stability history of the measuring equipment. • Equipment manufacturer’s recommendations. • The risk and consequences of an out-of-tolerance situation. • Acuteness of the measurements.
Global consumption of paper has grown 400% in the last 40 years. which means they are missing out on the benefits of moving towards a paperless calibration system. printer paper. perhaps even a poster on the wall. Whilst out in the field. Today. Globally. a paper-based calibration system involves the use of handwritten documents. significant benefits in minimising the use of paper. 101 . almost 4 billion trees or 35% of the total trees cut down across the world are used in paper industries on every continent (source: www. weighing instruments and pressure transducers. as businesses. especially given that there are technologies. our consumption of paper is far higher than it needs to be. which means they are missing out on the benefits of moving towards a paperless calibration system. there are other. software and electronic devices readily available today which render the use of paper in the workplace unnecessary. ecology. magazines. Other than helping to save our planet and reducing the number of trees cut down each year. As manufacturing companies. Take the calibration of plant instrumentation devices such as temperature sensors. Far too many of these companies still use paper-based calibration systems. amongst the process manufacturing industries. calibrating instruments is an enormous task that consumes vast amounts of paperwork.com).paperless calibration improves quality and cuts costs Paperless calibration improves quality and cuts costs P aper is part of our everyday lives – whether in the workplace or at home. Take a minute to look around the room you are in and you’ll notice how many objects are made from paper: books. a maintenance or service Far too many of these companies still use paper-based calibration systems. Traditional paper-based calibration systems Typically. So let’s not add to this already heavy burden on our forests and the environment.
On returning to the office. Paper systems are time consuming. as those individuals who need to sign off records or calibration 102 . These same companies that use paper-based calibration systems are together generating hundreds of thousands (millions?) of paper calibration certificates each year. paper-based system requires little or no investment in new technology or IT systems. blank calibration certificates. There will be less waiting time. However. So why would these companies generate and store separate paper copies of important records such as works orders. paper records that need approval have to be routed to several individuals. With paperless systems. workflow and making other significant cost savings for the business. which is time-consuming. Furthermore. After all. engineer will typically use a pen and paper to record instrument calibration results. workflow improves dramatically. there are practical reasons why firms should go paperless. important paper records could potentially be lost or damaged in an accident or fire. whilst also improving quality. standard operating procedures (SOPs). every square foot of the business has an associated cost. accessing calibration data quickly is not easy. etc. these organisations can significantly reduce their paper consumption.paperless calibration improves quality and cuts costs With paperless systems. While using a manual. workflow improves dramatically. In addition. it is extremely labourintensive and means that historical trend analysis of calibration results becomes very difficult. after which they are archived as paper documents. these notes are then tidied up and/or transferred to another paper document. Practical benefits of using less paper Aside from the financial benefits of moving towards a paperless calibration system. in industrial environments. when these records can all be combined into a single electronic record? Improved workflow With paper-based systems. they soak up lots of company resources and manual (typing) errors are commonplace. Often. Dual effort and the re-keying of calibration data into multiple databases become significant costs to the business. by utilising the latest software-based calibration management systems from companies like Beamex. it is not practicable to store or carry lots of paperwork.
especially if these paper records need to be typed or transcribed to a computer system or database. Data integrity The integrity of paper-based calibration systems cannot be relied upon. engineers and management will have more confidence in Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. which again has cost reduction benefits to the business. The whole calibration process – from initial recording of calibration data through to historical trend analysis – will take less time. Sometimes users may inappropriately modify the results data due to work pressures or lack of time/resources. whilst mistakes and manual errors will be virtually eliminated. Illegible handwritten notes are also a problem. For example. Just as important. Historical trending becomes easier. faster and more reliable. particularly when using weighscales or other instruments that are open to an individual’s own interpretation of the data. Costly production downtime due to unforeseen instrument failures will also be reduced. those instruments that are performing better than expected may well justify a reduction in their calibration frequency. 103 . particularly calibration results. Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. manual errors such as misreadings can occur. In turn. Paper records may not always reflect the truth. Transcription errors such as these can lead to all sorts of problems for a business and can take months to rectify or to identify the rogue data. this means that operators. electronic records enable easier analysis of data. Business benefits For those more enlightened companies that use software-based calibration systems. The cost and time associated with printing copies of paper documents is also eliminated. When a plant is being audited. calibration software facilitates both the preparation and the audit itself. Calibration intervals can be optimised. Locating records and verifying that the system works becomes effortless when compared to traditional paper-based record keeping. the business benefits are significant.paperless calibration improves quality and cuts costs documents can share or access electronic records simultaneously from a central database. as well as the cost of filing and storing those paper records. For example.
Although handover by commissioning teams that use paper records is straightforward and of universal format. resulting in completely paperless. without needing to collect all the plant data again. end-to-end workflows. electronic records simplify the handover of plant and equipment. data historians. this greater confidence in calibration data leads to a better understanding and analysis of business performance and KPIs (particularly if the calibration software is integrated with other business IT systems such as a CMMS) leading to improved processes. The un-editable electronic data stored on high performance multifunction calibrators can be uploaded to calibration management software for safe storage and asset management. particularly when it comes to plant audits. and for control systems. electronic records are easy to manipulate and can be re-used in different IT systems. In addition. Electronic data also provides an excellent foundation for ongoing plant operation and maintenance. business management systems. often in difficult industrial environments that would make the use of portable office computers impractical. in reality.paperless calibration improves quality and cuts costs the data. end-to-end workflows. A key part of paperless calibration records is the capture of data at point of work. 104 . In other words. increased efficiencies and reduced plant downtime. and the manual entry of calibration results into unintelligent calibration forms on portable industrial computers prone to eye-to-hand data mis-reads and repetitive strain induced error. How paperless should you go? Of course. Commissioning At plant commissioning times. One way to overcome these error prone data capture methods is to use portable documenting calibrators to measure what can be measured and provide intelligent. Companies can go even further than this and use electronic records for works orders. many companies are neither completely paperless nor rely solely on paper-based systems – the process is sometimes a hybrid of the two. resulting in completely paperless. technician friendly interfaces on industrialized PDA or tablet based hardware when manual data entry cannot be avoided. The calibration data is shared with other business IT systems electronically. the calibration data is shared with other business IT systems electronically.
Validation. which may be used to dealing with traditional. it is better to source the data electronically using documenting calibrators that are specifically designed for this task. This includes a functionality check on all of the pressure instrumentation. as this will help companies to overcome the natural resistance to change amongst the workforce. “It’s faster.” says Wright. Senior Instrument Technician David Wright recalls what it was like to perform all of those calibration operations with paper and pencil during the company’s regularly scheduled maintenance shutdowns: “It took us one week to perform the calibrations and a month to put together the necessary paperwork. which may be used to dealing with traditional. Oil Gas & Petrochemicals companies. the Croda plant uses pressurised vessels to purify lanolin for healthcare and beauty products.” Today.” Education and training for users is critical. Power & Energy. Based in East Yorkshire near Goole. Beamex provides comprehensive validation. Each vessel needs to be certified at least once every two years in order to demonstrate that the vessel is safe and structurally sound. Here. Case study Beamex is helping many organisations to implement paperless calibration management systems. paper-based systems. education and training services for customers. including Pharmaceuticals. Chemicals. which coordinates data collection tasks and archives the results. easier and more accurate than our old paper-based procedures. Croda uses the CMX calibration management software system from Beamex. as this will help companies to overcome the natural resistance to change amongst the workforce. Education and training for users is critical. “It’s saving us around 80 manhours per maintenance period and should pay for itself in less than three years.paperless calibration improves quality and cuts costs Suitable hardware Rather than rely on engineers in the field accurately keying in calibration results into suitably robust laptops or PDAs. Amongst these customers is UK firm Croda Chemicals Europe. as well as the sensors that monitor the incoming chemical additives and the outgoing effluent. training & education Paperless systems also need validating in the user’s own environment. paper-based systems. 105 .
Pre-commissioning activities are those which have to be undertaken 107 . or any defined part of a plant. Successful commissioning of process instrumentation is an essential requirement for ideal plant performance. These activities are usually described as ‘cold commissioning’. A plant. This article explains process instrument commissioning and the benefits of calibration during the commissioning phase. calibration of instrumentation. At the completion of commissioning. is ready for commissioning when the plant has achieved mechanical completion. Energizing power systems. commissioning activities are those associated with preparing or operating the plant or any part of the plant prior to the initial start-up and are frequently undertaken by the owner or joint owner/ contractor team. testing of the control systems as well as verification of the operation of all interlocks and other safety systems are also typical commissioning tasks. operational testing of plant equipment. What is process instrument commissioning? Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program.intelligent commissioning Intelligent commissioning C alibration plays a vital role in process plant commissioning and when installing new instruments. In general. the plant will be fully ready for production operation. Commissioning may involve mock operations which are commissioning activities conducted to allow operational testing of the equipment and operator training and familiarization. Plant commissioning involves activities such as checking to ensure plant construction is complete and complies with the documented design or acceptable (authorized and recorded) design changes.
because the funds have been allotted to cover budget overruns. and the re-commissioning activities have been completed to the extent where the owner approves the plant and can begin commissioning activities. and a schedule needs to be established for each task including benchmarks for monitoring purposes. such as adjustments and checks on machinery performed by the construction contractor prior to commissioning and without which the installation cannot be said to be mechanically complete. This can prove to be a worthwhile investment for large plants because it allows for dedicated responsibility and focus in operations and significant improvements to schedules. in fact. connecting to and identifying the field device. Some companies employ specialized commissioning engineers. Commissioning requires a team of people with a background in plant design. these steps must be repeated with every field device that will be installed at the plant. personnel and cost of commissioning Since commissioning takes place toward the end of the project. as the plant owner’s commitments in terms of product marketing and operational costs are likely to be higher. Management. there is a risk that the work may be under-resourced. The rate 108 . plant operation and plant maintenance. it may cost more. An extra day taken for commissioning means the same to the plant owner as an extra day taken during designing or construction. and adverse incidents at the start-up phase can be avoided. prior to operating equipment. physically installing the field device. and ensure this commitment is maintained. detailed planning of commissioning and plant handover are essential elements of the overall project plan and schedule as any other grouping of activities. Each of the commissioning activities must be broken down into a number of manageable tasks. As there are many cost factors in the commissioning process. It is essential to comprehend the scope and length of commissioning activities and include them in the initial project plan and budget allocations. Mechanical completion of a plant or any part of a plant occurs when the plant or a part of the plant has been completed in accordance with the drawings and specifications. Basically. configuring the required parameters and testing the configuration and interface to other systems. The cost of process instrument commissioning is typically affected by the following issues: learning and familiarizing with the field device.intelligent commissioning There are many reasons why instruments should be calibrated during the commissioning phase before start-up.
of commissioning is measurable (e. Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. Good planning. instrument and process engineers.intelligent commissioning Construction Pre-commissioning Mechanical completion Commissioning Trial operation Initial start-up Examine product specification Examine production performance Acceptance of plant The calibration database can be calibration software designed specifically for managing calibration assets and information. communications. such as the Beamex® CMX Calibration Software. documentation. thereby enabling progress to be reviewed regularly. The commissioning team consists of a mixture of specialists. number of loops or sequence of steps tested per day). instruments are often recalibrated upon arrival at the site. Calibration and the commissioning of field instrumentation New process instrumentation is typically configured and calibrated by the manufacturer prior to installation. Sequence of activities leading to commissioning and acceptance of a plant. However. especially if there has been obvious 109 . and the size of the team and composition of specialists depends on the nature and scope of the system. teamwork and training are all essential. coordination.g.
After you have performed this task. The new uninstalled instrument or transmitter may have the correct. Monitoring the quality and stability of a transmitter When calibration procedures are performed for an uninstalled instrument. Reconfiguring a transmitter The trick is determining which sensors should be recalibrated after a few hours. weeks. Entering the necessary transmitter data into a calibration database By calibrating an instrument before installation it is possible to enter all the necessary instrument data into the calibration database. Calibration is therefore a key element in the process of reconfiguring an uninstalled transmitter. Transmitters that are found to be highly stable need not be recalibrated as often as transmitters that tend to drift.intelligent commissioning damage in transit or storage. as was explained in the previous paragraph. specified settings. By calibrating an instrument you can check the settings of the instrument. weeks. You can check the overall quality of the instrument to see if it is defective and to ensure it has the correct. when the initial planned specifications have been changed. the calibration serves also future purposes. The transmitter information is critical in defining the quality of the instrument and for planning the optimal calibration interval of the instrument. it is possible that the original planned settings are not valid anymore and they need to be changed. or years of operation and which can be left as is for 110 . such as the Beamex® CMX Calibration Software. Calibrating a new instrument before installing or using it is a quality assurance task. it is possible to reconfigure the transmitter. By calibrating the transmitter before installation and on a regular basis thereafter. The trick is determining which sensors should be recalibrated after a few hours. the fact that an instrument or transmitter is new does not automatically mean that it is within required specifications. or years of operation and which can be left as is for longer periods without sacrificing quality or safety. Assuring transmitter quality First of all. However. specified settings. There are also many other reasons why instruments should be calibrated during the commissioning phase before start-up. it is possible to monitor the stability of the transmitter. The calibration database can be calibration software designed specifically for managing calibration assets and information. as well as to monitor the instrument’s stability.
which mean that they can be used to replace several individual measurement devices. Engineers performing calibrations no longer have to write down any results on paper. The Beamex® CMX can be used for planning and scheduling calibrations. The Beamex calibrators are all-in-one calibrators. Foundation Fieldbus and Profibus. are they installed and ready for calibration. overlooked or become overdue. Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks do not get forgotten. does anyone perform the calibration (check in/out function) and what is the instrument/position status (pass/fail). Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important. Using the CMX gives always a clear status of the transmitters. The Beamex calibrators support various different transmitter protocols. electrical and frequency signals. the calibration results are stored automatically in the calibrator’s memory during the calibration process. Doing so allows maintenance personnel to concentrate their efforts only where needed. smarter and more accurate management of all calibration assets and procedures. All calibration documentation is Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks do not get forgotten. entering the instrument data into a calibration management system is part of the calibration procedures performed on an instrument before it is installed and in use. thereby eliminating unnecessary calibration work.intelligent commissioning longer periods without sacrificing quality or safety. making the entire process much quicker and reducing costs. overlooked or become overdue. The Beamex® MC series documenting calibrators can be used for calibrating pressure. improves the quality and efficiency of the entire calibration system through faster. Integrated calibration solution by Beamex The Beamex® Integrated Calibration Solution. HART. consisting of calibration software and documenting calibration equipment. Therefore. The Beamex® CMX Calibration Software can be used for improving the quality. for instance. such as analog. Intrinsically safe calibrators for potentially explosive environments are also available. 111 . managing and storing all calibration data as well as analyzing and optimizing the calibration interval. productivity and cost-effectiveness of a plant’s calibration process. By using a documenting calibrator. temperature.
saving time and money. as there are fewer mistakes due to human error. This means that engineers do not spend their time transferring the results from their notepad to final storage on a computer. again. therefore automatically produced when using the Beamex® Integrated Calibration Solution. The quality and accuracy of calibration results also improve. The calibration results are transferred automatically from the calibrator’s memory to the computer/ database. Major time-savings can also be achieved by using Beamex’s documenting MC calibrators HART and/or Fieldbus functionality to enter transmitter data into the calibrators’ memory where the data can be populated to the CMX Calibration Software.intelligent commissioning By using a documenting calibrator. SUMMARY Calibration is beneficial during process plant commissioning for various different reasons: • Transmitter quality assurance • Reconfiguring a transmitter • Monitoring the quality and stability of a transmitter • Entering the necessary transmitter data into a calibration database and defining the optimal calibration interval 112 . instead of typing the data manually into the calibration database. the calibration results are stored automatically in the calibrator’s memory during the calibration process.
especially if the company is part of an asset-intensive industry. For this. nuclear. flow meters and the like – are performing and measuring to specified tolerances. If sensors drift out of their specification range. Manufacturing plants need to be sure that their instrumentation products – temperature sensors. paper. complex and expensive. Maintaining plant assets – whether that includes production line equipment. 115 . special purpose machines. but critical part of a company’s asset management strategy should be the calibration of process instrumentation. safety issues or batches of inferior quality goods being produced. is critical to business efficiency. having a reliable. has proved itself time and time again across many industry sectors. If stoppages to production lines due to equipment breakdowns are costly. which then have to be scrapped. a small. or across multiple sites. perhaps resulting in costly production downtime. the consequences can be disastrous. seamlessly integrated set of IT systems across the plant. Maintenance management has become an issue which deserves enterprise-wide and perhaps multi-site attention. a small. metal processing. where equipment and plant infrastructure is large.successfully executing a system integration project Successfully executing a system integration project F or process manufacturers today. furnaces. In the process industries. conveyor systems or hydraulic pumps – is equally critical for these companies. profitability and growth. including pharmaceuticals. oil and gas. implementing the latest computerized maintenance management systems (CMMS) might save precious time and money. chemicals. boilers. pressure transducers. Beamex® CMX. but critical part of a company’s asset management strategy should be the calibration of process instrumentation. Beamex’s calibration management software. In the process industries.
Beamex® CMX helps companies document. schedule. The integration project involves three main parties: Beamex. 116 . CMX can also download detailed instructions for operation before and after calibrating. Calibration work orders can easily be transferred to CMX Calibration Software.successfully executing a system integration project Seamless communication Today. once the calibration work order has been executed. Integration project A customer may have a large CMM system and a considerable amount of data keying to perform before integration is complete. CMX sends an acknowledgement order of this work back to the customer’s CMM system. in-house software for maintenance management. Integrating CMX with a CMM system means that plant hierarchy and all work orders for process instruments can be generated and maintained in the customer’s CMM system. whether it is a Maximo. plan. most process manufacturers use some sort of computerized maintenance management system (CMMS) that sits alongside their calibration management system. A data exchange module or interface that sits between the two systems is required. Seamless communication between CMX and ‘smart’ calibrators means that companies have the ability to automate predefined calibration procedures. like procedures. CMX also stores the complete calibration history of process instruments and produces fully traceable calibration records. Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems. whether it is a Maximo. the customer and the CMM system software partner. Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems. As well as retrieving and storing calibration data. SAP or Datastream CMM system or even a company’s own. elimination of human error associated with manual recording. All detailed calibration results are stored and available on the CMX database. Seamless communication with calibrators also provides many practical benefits such as a reduction in paperwork. reminders and safety-related information. Then. analyze and optimize their calibration work. in-house software for maintenance management. SAP or Datastream CMM system or even a company’s own. and the ability to speed up the calibration task.
agreement. Moreover. Installation. The project manager is usually responsible for the operative management of the project. project plan or other document annexed to the offer / agreement. 117 . Scope of Work 2. It’s also essential that the main roles and responsibilities of the parties are specified before the project evolves. Each project phase should be approved according to the acceptance procedures defined in the offer. a project steering group may need to be established. The project steering group is responsible for making key decisions during the project. Verification and Training The four main phases are also often divided into sub-phases. A schedule is usually defined for the completion of the entire project as well as for the completion of each project phase. a project organization should be established and include members from both the supplier’s and the customer’s organization. In addition. Development and Implementation 3. Testing 4. the customer and the CMM system software partner. The role. Project phases The integration project is divided into four main phases: 1. as a successful project requires input from both parties. The integration project involves three main parties: Beamex.successfully executing a system integration project Project organization and resourcing In order to have a successful integration. tasks and authority of the project steering group must be defined as well as the decision-making procedures. The role of each member should be defined and project managers appointed. it’s important that the right people and decision-makers are involved and participate right from the beginning of the project.
main roles. This is an urgent but time-consuming matter and can be avoided if the right people and decision-makers participate in the first project phase. The scope of work should include a brief project description. However. as changes to the original scope of work may be necessary and required even in projects where the SOW phase has been done carefully. partner responsibilities and the desired outcome. 118 . The SOW is often developed through pre-studies and workshops. scheduling and costs of the project depend greatly on the scope of work. questions or problems may appear later in the project.successfully executing a system integration project Scope of work To ensure successful integration with a satisfied customer. Defining what is not included in the scope of work is just as important as defining what is included in it. which will direct the project back to phase one where a review of the scope is necessary. services provided. If the scope of work is not defined carefully. as the resourcing. it is important that the supplier and customer agree on change management procedures as early as the starting phase of the project. This means that establishing some framework and limitations for the project are also very important. The scope of work is important to make sure that both the supplier and the customer have understood the project in question and they have similar expectations from it. defining the correct scope of work (SOW) is crucial.
and at the final stage of the project. training and providing training materials. in order to be able to continue the development work to next phase. The supplier will. which is the actual development and implementation of the project deliverables. if required and agreed. The project manager at the buyer’s facility now plays a major role in the success of the integration process. approval procedures and timelines should be defined when agreeing on the project.successfully executing a system integration project Development and implementation When the scope of work has been defined and approved by both parties. • Purpose / needs • Target • Supplier’s responsibilities • Customer’s responsibilities • Project management and project steering group Scope of work (SOW) Speciﬁcations documentation • Change management Development and implementation Implementation documentation • Testing and acceptance procedures Testing Testing documentation • Final approval by customer Installation Veriﬁcation Training Instructional documentation FOLLOW UP CLOSURE OF INTEGRATION PROJECT 119 . the customer has a system that saves time. reduces costs and increases productivity by preventing unnecessary double effort and re-keying of procedures in separate INTEGRATION PROJECT PHASES When the integration is finished. verification and training The final stage in the integration process is the installation and testing at the customer’s facility and taking the system into production use. The testing. Testing Testing occurs both during the project after each partial delivery. the integration can enter the next phase. assist with informing. reduces costs and increases productivity by preventing unnecessary double effort and rekeying of procedures in separate systems. Installation. the customer has a system that saves time. When the integration is finished.
EAM is more than just maintenance management software. This improves the quality of the entire system. Integrating a CMM system with calibration management software is an important step in the right direction when it comes to EAM. a corresponding increase in asset utilization or plant uptime. When there is no need to manually re-key the data. However. more efficient use of maintenance staff. and optimized scheduling of maintenance tasks and resources. typing errors are eliminated. particularly with production teams. the data has to be as close to 100% accurate as possible to get maximum benefit from the system. 120 . Enterprise Asset Management. better management of spare parts and equipment stocks. But the key to success is really the quality of information you put in the software. the most common benefits being: less equipment breakdowns (leading to a reduction in overall plant downtime). It’s about companies taking a business-wide view of all their plant equipment and coordinating maintenance activities and resources with other departments and sites.successfully executing a system integration project Integrating a CMM system with calibration management software is an important step in the right direction when it comes to EAM. Enterprise Asset Management. Savings from EAM are reasonably well-documented and come in various guises. systems. A CMMS integration will enable the customer company to automate its’ management with smart calibrators.
Calibration in Industrial Applications .
Some calibrators can read HART. In plant areas where instrument accuracy is critical to ensure product quality. the key final step in any calibration process – documentation – is often neglected or overlooked because of a lack of resources. The purpose of calibration itself is to determine how accurate an instrument or sensor is. regular calibration of instruments throughout a manufacturing plant is common practice. What is a documenting calibrator? A documenting calibrator is a handheld electronic communication device that is capable of calibrating many different process signals such as pressure. calibration every six months – or even more frequently – is not unusual. 125 .the benefits of using a documenting calibrator The benefits of using a documenting calibrator F or process manufacturers. and then automatically documenting the calibration results by transferring them to a fully integrated calibration management software. Many process plants are under pressure to calibrate instruments quickly but accurately and to ensure that the results are then documented for quality assurance purposes and to provide full traceability. time constraints or the pressure of everyday activities. many process plants are under pressure to calibrate instruments quickly but accurately and to ensure that the results are then documented for quality assurance purposes and to provide full traceability. temperature and electrical signals. Although most instruments are very accurate these days. However. regulatory bodies often need to know just how inaccurate a particular instrument is and whether it drifts in and out of a specified tolerance over time. including frequency and pulses. Foundation Fieldbus or Profibus output of the transmitters and can even be used for configuring ‘smart’ sensors. safety or custody transfer. Indeed.
having an easy-touse documenting calibrator is definitely the way forward. especially if calibration is one of the many tasks that the user has to carry out in his daily maintenance routine. With a documenting calibrator. The engineer does not have to write any results down on paper. Performing the calibration procedure in the same way each time is important for the consistency of results. but which also integrates and automatically transfers this information to some sort of calibration management software. the calibration procedure can be automatically transferred from the computer to the handheld calibrator before going out into the field. By using a documenting calibrator. who are out in the field performing instrument calibrations. the calibration procedure itself is critical.” With a multi-functioning documenting calibrator. again. or stores calibration data from instruments but is not integrated to a calibration management system. “I would define a documenting calibrator as a device that has the dual functionality of being able to save and store calibration results in its memory. are entered once into the calibration management software and then downloaded to the calibrator. which makes the entire process much faster and consequently reduces costs. The calibration results are automatically transferred from the calibrator’s memory to the computer/database. spreadsheet or paper filling system.” A non-documenting calibrator is a device that does not store data. which makes the entire process much faster and consequently reduces costs. As Laurila states. The tolerances and limits for a sensor. “Engineers. such as the 126 . saving time and money. as well as detailed instructions on how to calibrate the transmitter. the calibration results are stored automatically in the calibrator’s memory during the calibration process. This means calibrations are carried out in the same way every time because the calibrator tells the engineer which test point he needs to measure next. The quality and accuracy of calibration results will also improve. Product Manager at Beamex in Finland comments. Calibration results have to be keyed manually into a separate database. receive instant pass or fail messages with a documenting calibrator. Also.the benefits of using a documenting calibrator Heikki Laurila. With instrument calibration. as there will be fewer mistakes due to human error. This means the engineer does not have to spend time transferring the results from his notepad to final storage on a computer. Why use a documenting calibrator? The engineer does not have to write any results down on paper.
Unintentional errors often occur and the whole process is timeconsuming. and the system provides full traceability. The corresponding calibration results for these instruments can be saved in the device without the user having to return to his PC in the office to download/upload data. the field engineer calibrates the instrument. When you’ve got to calibrate instruments throughout a site. handwrites the results onto a paper form and then reenters this information into a database when he returns to the office. such as the MC5 or the MC6. “With a documenting calibrator. Foundation Fieldbus H1 or Profibus PA transmitters. January. the user can download calibration instructions for hundreds of different instruments into the device’s memory before going out into the field. Laurila continues. Both calibrators can be used also to calibrate.” Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important.* Why? Because the devices provide higher accuracy. This means the user can work in the field for several days.the benefits of using a documenting calibrator Beamex® MC5 or MC6. overlooked or overdue. 2004 Calibration software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. ___________________ * Reported to the Industrial Instrumentation and Controls Technology Alliance and presented at the TAMU ISA Symposium. typically with five-point checks on each instrument. Benefits in practice Conventional calibration work relies on manual. overlooked or overdue. the calibration process is much faster. 127 . speed and accuracy are critical. configure and trim HART. Manual calibration takes more time and is more prone to error. the user doesn’t need to carry as much equipment while out in the field. Oftentimes. paper-based systems for documenting. Using the MC6 or MC5 with CMX software means that calibration instructions for an instrument and calibration orders are downloaded to the calibrators and ready to guide the engineer in the field with correct calibration procedures. Using Beamex® CMX Calibration Software and the documenting Beamex® MC6 or MC5 Multifunction Calibrators provides full control of the entire calibration process and reduces costs by up to 50 % .
again. • Calibration results are automatically transferred from the calibrator’s memory to a computer or fully integrated calibration management system. 128 . • The calibration procedure itself is guided by the calibrator. consistency and quality of calibration results. which uploads detailed instructions from the computer or calibration management software. saving time and money and simplifying the process. SUMMARY The benefits of using a documenting calibrator Calibration results are automatically transferred from the calibrator’s memory to a computer or fully integrated calibration management system. • Reduced costs from a faster and more efficient calibration process. • No manual printing or reading of calibration instructions is required. • Calibration results are automatically stored in the calibrator’s on-board memory during the calibration procedure. • A fully traceable calibration system for the entire plant.the benefits of using a documenting calibrator After completing instrument calibrations. This not only ensures full traceability but also reflects full and traceable documentation of the completed work. the system provides a full quality assurance report of all instruments calibrated along with a required calibration certificate. • Less paperwork and fewer manual errors. • Improved accuracy.
From a regulatory point of view. and the user must have the knowledge to apply the information achieved through calibration. Verification and calibration abide by a different philosophy. Using weighing instruments for legal purposes must have legal verification. Calibration depicts the deviation between indication and reference (standard) including tolerance. the quality of a weighing instrument is already defined in OIML regulations. whereas verification depicts the In any case. usually called scales or balances. but in the EU they are the same. should provide the correct weighing results. weighing instruments. How the weighing instrument is used and how reliable the weighing results are can be very different. If a weighing instrument is used in a quality system. (S)He must select the weighing instrument and maintenance procedure to be used to reach the required measurement capability. it is the owner or the user of the instrument that carries the final responsibility of measurement capability and who is also responsible for the processes involved. at least at the stage when the weighing instrument is being introduced into use. In any case. Calibration and legal verification Weighing instruments may also possess special features. at least in Europe. Calibration is a means for the user to obtain evidence of the quality of weighing results. the user must define the measurement capability of it. 131 . for example when invoicing is based on the weight of a solid material. The features may vary slightly from country to country.calibration of weighing instruments part 1 Calibration of weighing instruments Part 1 F rom the point of view of the owner. One of these features includes making measurements for which legal verification is required. it is the owner or the user of the instrument that carries the final responsibility of measurement capability and who is also responsible for the processes involved.
However. Comparing the indication of weighing instruments with a set standard gives the deviation or error. We must remember that the quality of the evaluation of measuring tolerance depends on the collected information through calibration. we need more information about the weighing instrument. such as repeatability. In practice. Confirming the capability of weighing instruments should happen by estimating the quality of the measuring device in the place where it will be used. One calibration provides information on a temporary basis and a series of calibrations provides time-dependent information. The practical work for both methods is very similar and both methods can be used to confirm measurement capability. The method should be precise for achieving comparable results during all calibrations. The terminology and practices used previously for verifying measurement capability. including information for other measuring devices. This is a feasible practice for all weighing. which goes through the same steps for every calibration – calculates deviation and measuring tolerance. etc. and for weighing technology in general. this means investigating the efficiency of the weighing instrument. produces a calibration certificate – is the best way to achieve reliable information to use in comparisons. and it displays the history of calibrations and in this way provides the user with comprehensive information concerning measuring capability. The most important aspect of a calibration program is that it allows the user to select the calibration method that corresponds to the required level of measuring tolerance.calibration of weighing instruments part 1 maximum permissible amount of errors of the indication. Confirmation is the collecting of information We must remember that the quality of the evaluation of measuring tolerance depends on the collected information through calibration. to be able to define the measuring tolerance. hysteresis. 132 . if necessary. eccentric load. Using a calibration program. This type of program is able to store all the history of calibrated weighing instruments. are based on these practices of calibrating and verifying. this operation is known as calibration (or verification). and. The method of calibration should be selected such that it provides sufficient information for evaluating the required measuring tolerance. as long as legal verification is not needed. It is also handy for monitoring measuring systems. even if it was a question of general weighing (non-legal).
Calibration should be carried out using settings based on the parameters for normal use. as well as many other instruments. the idea is that the weighing instrument remains in good working condition until the next calibration.calibration of weighing instruments part 1 The purpose of calibration and complete confirmation Calibration is a process where the user is able to confirm the correct function of the weighing instrument based on selected information. Since there are several parameters in use. The factors in question may include the effect of the environment where the weighing instrument is used and how often the instrument needs to be cleaned. however. 133 . is a short-term process. regular monitoring of the zero point and the indication number with a constant mass. the idea is that the weighing instrument remains in good working condition until the next calibration. the user must determine all of the external factors which may influence the proper functioning of the weighing instrument. The user must define the limits for permitted deviation from a true value and required measuring tolerance. is a short-term process. Calibration itself. However. They possess several possibilities for adjusting parameters in measuring procedures. Therefore. The calibration certificate of a single measuring device is used as a tool for evaluating the process of measuring tolerance and for displaying the traceability of the device in question. as well as calibration personnel. Performing calibrations based on the measuring tolerance is better than doing routine measuring. it is important to always have the manual for using the weighing instrument easily available to the user. is based on microprocessors. It is very important that the users of the weighing instruments. an adjustment or maintenance is necessary. The content of the calibration certificate Very often the calibration certificate is put on file as evidence of a performed calibration to await the auditing of the quality system. are familiar with these parameters and use them as protocol. If these values are exceeded. Calibration itself. For this reason. however. Today. the function of weighing instruments. a quality system is usually concerned with the traceability of measurements and the known measuring tolerance of the measurements made. the user must evaluate the process of measuring tolerance and compare this value with the required measuring tolerance of the process.
The following must be taken into consideration: • the type of procedure to be applied in confirming measuring tolerance • the interpretation of information while abiding by the calibration certificate • changing procedures based on received information Quality calibration methods and data handling systems offer state-of-the-art possibilities to any company. It also assists the user in obtaining the required quality of measurements in a process.calibration of weighing instruments part 1 SUMMARY Calibration (or verification) is a fundamental tool for maintaining a measuring system. 134 .
calibration of weighing instruments part 1 135 .
e. Guidelines on the Calibration of Non-automatic Weighing Instruments. Originally.e. Repeated weighing measurements provide different indications Usually. often need to know just how inaccurate a particular scale may be. the object being weighed is placed on the load receptor and the weighing result is read only once. Weighing instruments are often highly accurate. their customers and/or regulatory bodies. which was prepared by the European Co-operation for Accreditation. and published by the European Collaboration in Measurement and Standards (euromet). often need to know just how inaccurate a particular scale may be. 137 .calibration of weighing instruments part 11 Calibration of weighing instruments Part 2 W eighing is a common form of measurement in commerce. but users. tests for determining minimum weighing capability are also performed. or on the potential consequences of erroneous weighing results. industries and households. Typical scale calibration involves weighing various standard weights in three separate tests: • repeatability test • eccentricity test • weighing test (test for errors of indication) In the pharmaceutical industry in the United States. Typical calibration procedures Calibrating scales involves several different procedures depending on national. the equipment was tested or calibrated on a regular basis. Subsequently. i.and/or industry-specific guidelines or regulations. their customers and/or regulatory bodies. One clear and thorough guide is the EA-10/18. i. this information was obtained by classifying and verifying the equipment for type approval. If you weigh the object Weighing instruments are often highly accurate. but users.
calibration of weighing instruments part 11 repeatedly.73%. This is sometimes difficult due to the shape or construction of the object being weighed. but users. random variation in the indications. You must also know how certain you can be about the error found at each point of calibration. Test for errors in indication The weighing test examines the error of the indication on the scale for several predefined loads. This enables you to correct the errors and definitions for non-linearity and hysteresis. often need to know just how inaccurate a particular scale may be. Typical calibration procedures include the eccentricity test. The repeatability test involves weighing an object several times to determine the repeatability of the scale used. e. you will notice slight. Center of gravity matters The eccentricity test involves placing the object being weighed in the middle of the load receptor as accurately as possible.1% of the weight. There are several sources of uncertainty of the error. suitable substitution mass is used instead.: Weighing instruments are often highly accurate.g. You can determine how much the eccentricity of the load will affect the indication on the scale by weighing the same weight at the corners of the load receptor.e. it may be impractical to use standard weights for calibrating the entire range. with a probability of 99. their customers and/or regulatory bodies. In such a case. If the scale’s maximum load limit is extremely large. which can be assuredly and accurately measured using the scale in question. i. Combined standard uncertainty of the error U(E) Knowing the error of the scale indication at the point of each calibration is not sufficient. Substitution mass should also be used if the construction of the scale does not allow the use of standard weights. A truck scale is unsuitable for weighing letters The purpose of the minimum weight test is to determine the minimum weight. 138 . This condition is met if the measurement error is less than 0.
air temperature and humidity. • Digital scale indications are rounded to the resolution in use.1 g 2.27% as well. is between is between 1.27% U(E) = 2u(E) 95.8 g and 3. • Air convection causes extra force on the load receptor.4 g 1.g.2 g 3.45 % U(E) = 3u(E) 99.5 g ±u(E) 68. • Analogous scales have limited readability. 139 .9 g 4.27%.6 g Example: The calibration error and its uncertainty at the calibration point of 10 kg may be expressed e.27%). • There are random variations in the indications as can be seen in the Repeatability Test.calibration of weighing instruments part 11 • The masses of the weights are only known with a certain uncertainty. • Air buoyancy around the weights varies according to barometric pressure.73 % 3. • The weights are not in the exact middle of the load receptor. 1. with a coverage probability of 68.7 g. • A substitute load is used in calibrating the scale. which correspond to one standard deviation of a normally distributed variable. E = 2. The combined standard uncertainty of the error at a certain point of calibration has a coverage probability of 68.5 g and the actual error.8 g 0. The values of uncertainty determined at each point of calibration are expressed as standard uncertainties (coverage probability: 68.5 g and u(E) = ±0.2 g. which means that the calculated error in the indication is 2.
• The temperature.0039 kg 95.45% of the time.45% by multiplying it with the coverage factor k = 2.0011 kg and 10. This means that the calculated error of the indication is 2. If the distribution of the indicated error cannot be considered normal. • The adjustment of the weighing instrument may have changed. barometric pressure and relative humidity of the air may vary. Typical reasons for this are: • Routine weighing measurements involve random loads. with a coverage probability of 95. • Loading/unloading cycles in calibration and routine weighing may be different. If you are able to use the k = 2 coverage factor. or the reliability of the standard uncertainty value is insufficient. • A load may be situated eccentrically in routine weighing.1 g and 3.5 g and the actual error. then a larger value should be used for the k-factor. As the above-mentioned case indicates. • Finer resolution is often used in calibration. the indication of weighing an object of 10 kilograms will be between 10. at least once. Normally. it is extended to a level of 95. Uncertainty of a weighing result The purpose of calibration is to determine how accurate a weighing instrument is. the uncertainty of the results of later routine weighings is usually larger. then the error and its extended uncertainty at the point of calibration are E = 2.45%. you know that if you repeat the calibration several times. Standard and expanded uncertainties of weighing results are calculated using technical data of the weighing instrument.27% is insufficient. is between 1. a coverage probability of 68.9 g. while calibration is made at certain calibration points. its calibration results. Defining the uncertainty of weighing results is highly recommended.5 g and U(E) = ±1. for all The purpose of calibration is to determine how accurate a weighing instrument is. However.4 g. 140 . • Tare balancing device may be used in routine weighing.calibration of weighing instruments part 11 Expanded uncertainty in calibration U(E) In practice. • Routine weighing measurements are not repeated whereas indications received through calibrations may be averages of repeated weighing measurements. knowledge of its typical behaviour and knowledge of the conditions of the location where the instrument is used.
However. Error limits can be set according to OIML or Handbook-44. 141 . CMX’s versatile calibration certificate and possibility to define a user specific certificate assure that you can fulfill requirements set for your calibration certificates. Calibrating and testing weighing instruments using CMX CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument. determining the uncertainty of weighing results is not part of calibration. CMX calculates combined standard uncertainty and expanded uncertainty at calibration of the weighing instrument. Correspondingly. user-defined uncertainty components in addition to supported uncertainty components. Wide variation in user-specific limits is also possible. Calculating the uncertainty of weighing results assists you in deciding whether or not the accuracy of the weighing instrument is sufficient and how often it should be calibrated. copying configurations from one scale to another is easy.calibration of weighing instruments part 11 typical applications and always for critical applications. It allows you to enter additional. CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument.
The polynoms are specified in ITS 90 table (International Temperature Scale of 1990). Metrology contains mathematic formulas for calculating uncertainty. being a state of equilibrium. and its influence on e. Every temperature measurement is different. It is important to keep in mind an old saying: all meters.calibrating temperature instruments Calibrating temperature instruments T he most commonly and most frequently measurable variable in industry is temperature. RTD) or convert temperature into low voltage (Thermocouples. including sensors. it is necessary to calibrate the instrument and the temperature sensor. RTD’s are based While standards determine accuracy to which manufacturers must comply. 143 . They either convert temperature into resistance (Resistance Temperature Detectors. Temperature. show incorrectly. a model that includes all influencing factors must be created. If temperature is a significant measurable variable from the point of view of the process. For each measurement. they nevertheless do not determine the permanency of accuracy. A temperature measurement consists of several time constants and it is crucial to wait until thermal equilibrium is reached before measuring. T/C). Therefore. While standards determine accuracy to which manufacturers must comply. the user must be sure to verify the permanency of accuracy. they nevertheless do not determine the permanency of accuracy. makes it different from other quantities. which makes the temperature calibration process slow and expensive. calibration will prove by how much. quality. energy consumption and environmental emission is significant. Temperature sensors The most commonly used sensors in the industry used for measuring temperature are temperature sensors. Temperature greatly influences many physical features of matter.g.
Sensors are calibrated either by using temperature dry blocks for industrial field or liquid baths (laboratory). but the difference in temperature. PtRh/Pt/Rh) are used especially in high temperatures for better accuracy and stability. To make comparisons. are also being adopted. but to achieve better accuracy and reliability. The most important criterion in the calibration of temperature sensors is how accurate the sensors are at the same temperature. The most common T/C type is the K-type (NiCr/NiAl). This means that the thermocouple is not measuring the temperature. Temperature transmitters The signal from the temperature sensor cannot be transmitted a longer distance than the plant. Thermocouple consists of two different metal wires connected together. The uncertainty of calibration is not the same as the accuracy of the device. temperature transmitters were developed to convert the sensor signal into a format that can be transmitted easier.calibrating temperature instruments on the fact that the resistance changes with temperature. If the connections (hot junction and cold junction) are at different temperatures. Therefore. Calibrating temperature instruments To calibrate a temperature sensor.or B-type (PtRh/Pt. it also has an impact on the total accuracy. a small temperature dependent voltage difference/current can be detected. A temperature transmitter can be calibrated using a temperature calibrator. while the transmitter converts the sensor signal. and therefore the transmitter must be calibrated on regular basis. such as Fieldbus transmitters. Pt100 is a common RTD type made of platinum and its resistance in 0 ˚C (32 ˚F) is 100∧. an external reference temperature sensor is recommended. The heat source may also have an internal temperature measurement that can be used as reference. we compare the sensor to be calibrated and the reference sensor. and performing calibration is not the least influencing factor. it must be inserted into a known temperature. Many factors influence the total uncertainty. Nowadays. Despite their lower sensitivity (low Seebeck coefficient). the noble thermo-elements S-. transmitters with a digital output signal. All heat 144 . The most important criterion in the calibration of temperature sensors is how accurate the sensors are at the same temperature. the transmitter converts the signal from the temperature sensor into a standard ranging between 4 and 20 mA. R. Most commonly.
Stability Stability means variation of the temperature in the measurement zone over time when the system has reached equilibrium. Loading effect When several sensors are placed in the borings of the heat source. The uncertainty of calibration is not the same as the accuracy of the device. These effects can be quantified to determine the heat source’s contribution to the measurement uncertainty. heat flux along the length of the thermometer stem. Immersion depth To achieve a more stable calibration. The major sources of measurement uncertainty are axial homogeneity. Measurement uncertainty Axial homogeneity Axial homogeneity is the temperature distribution in the measurement zone along the boring (axial temperature distribution). loading effect. 145 . This phenomenon is called loading effect. Thirty minutes is commonly used. stability and immersion depth.calibrating temperature instruments sources show measurement errors due to their mechanical design and thermodynamic properties. Guidelines for minimizing measurement uncertainty should be applied according to Euramet/cg-13/v. they will affect accuracy. Stem conduction. the immersion depth for a probe should be sufficient for the sensor being calibrated. Radial homogeneity Radial homogeneity can be explained as the difference in temperature occurring between the borings.01 (former EA-10/13). affects both the reference sensor and the unit being tested. radial homogeneity.
says Raimo Ahola. However. regular calibration of sensors and traceable calibration as well as calibration documentation. where the computer controls the calibration event. The Beamex® Integrated Calibration Solution concept is the combination of calibrator. CEO of Beamex Group. both in numeric and in graphic form. The ISO quality control system presupposes the quality control of calibration. The level of performance a calibration device needs to have depends on the accuracy requirements determined by each company. The Beamex® FB and MB dry blocks are part of the Beamex® Intergrated Calibration Solution. The dry blocks communicate with the Beamex documenting multifunction calibrators enabling fully automated temperature calibration and documentation. calibration software and PC for online calibration. such as a series of highquality dry blocks for field and laboratory use. The instrument’s calibration information is saved in the calibrator and History Trend reports. It is a complete solution for temperature calibration with various products and services. “This helps the client to follow the condition of the instrument. the calibration device must always be more accurate than the instrument or sensor being calibrated. more accurate and efficient management of all calibration assets and procedures”. the calibration of instruments effecting production. determining service in advance and recalibration. the calibration device must always be more accurate than the instrument or sensor being calibrated. Calibration of instruments and sensors can be carried out either on site or in a laboratory. you can print out a calibration report as well as a traceable. The instrument to be calibrated is connected to the calibrator controlled by a computer. Integrated calibration solution – a smarter way to calibrate temperature Beamex has introduced a smarter. With the CMX Software. The calibration results can then be uploaded from the documenting calibrators to the Beamex® CMX Calibration Software. which is useful in making decisions about purchasing new instruments.calibrating temperature instruments The calibration of instruments and sensors must be performed periodically. a complete calibration solution that enables faster. more efficient and accurate solution for calibrating temperature. smart reference probes and temperature calibration laboratory services. 146 . However. “The temperature products and services we are now introducing form an integral part of the Beamex® Integrated Calibration Solution.
The Beamex® Integrated Calibration Solution concept is the combination of calibrator. eliminates any errors related to manual entry and assures repeatable calibration procedures”. 147 . Mr Ahola adds. calibration software and PC for online calibration.calibrating temperature instruments accredited calibration certificate. Our integrated calibration solution concept saves valuable time.
01. July 2007 [previously EA-10/13]): • The Euramet calibration guide defines a normative way to calibrate There are fast and lightweight dry blocks for industrial field use as well as models that deliver near bath-level stability in laboratory use. 149 . it could even cause a small steam explosion which may splash hot oil on the user. There are also some work safety issues that favor dry blocks in preference to liquid baths. What is a temperature dry block? A temperature dry block consists of a heatable and/or coolable metallic block. in temperatures above 200 °C liquids can produce undesirable fumes or there may be fire safety issues. If a drop of water gets into hot silicon oil. but they don’t necessarily improve performance. This article will focus on models that use interchangeable metallic multi-hole inserts. They may actually even impede the dry block’s performance and damage its internal components. an internal control sensor and optional readout for external reference sensor. controller. It will also present how to calculate the total uncertainty of a calibration performed with a dry block. Heat transfer fluids or pastes are sometimes used around or inside the insert. EURAMET The EURAMET guideline (EURAMET /cg-13/v. Dry blocks are almost without exception meant to be used dry.total uncertainty of temperature calibration Calculating total uncertainty of temperature calibration with a dry block T his article will discuss the various uncertainty components related to temperature calibration using a temperature dry-block. For example. There are fast and lightweight dry blocks for industrial field use as well as models that deliver near bath-level stability in laboratory use.
total uncertainty of temperature calibration dry blocks. It is possible to use a dry block with the block’s internal measurement as the reference (true value). Some manufacturers specify these components and some do not. With dry blocks.0 mm at +660…1 300 °C) Related uncertainty components Uncertainty components that are related to temperature calibration are relevant to all manufacturers’ dry blocks. • Main topics in the EURAMET guideline include: – Display accuracy – Axial uniformity – Radial uniformity – Loading – Stability over time – Hysteresis – Sufficient immersion (15 x diameter) – Stem loss for 6 mm or greater probes – Probe clearance (<= 0. The Euramet calibration guide defines a normative way to calibrate dry blocks. Internal measurement as reference When using a dry block’s internal measurement as reference. the following uncertainty components should be taken into account: • D isplay accuracy (accuracy of the internal measurement) It is important to remember that all of the thermometers based on thermal contact measure their own temperature. whereas the probes to be calibrated are immersed in the insert. As most of the manufacturers nowadays publish their product specifications including the main topics in the Euramet guide. the products are easier to compare.5 mm at –80…660 °C) (<= 1. There is always thermal resistance between the internal sensor and the probes inside the insert and other sources of uncertainty need to be considered. the internal control sensor is typically located inside the actual block. 150 . or to use an external reference temperature probe inserted in the block as a reference measurement.
151 . by the placement of the heaters. The thermocouple typically has its “hot junction” close to the tip of the probe whereas the PRT sensing element may be 30 to 50 mm long. Non-symmetrical loading or probes with significantly different thermal conductivity (for example large diameter probes) may cause additional temperature variation. “dry wells should have a zone of sufficient temperature homogeneity of at least 40 mm in length” at the bottom of the insert. The Euramet calibration guide states. a homogenous zone of at least 60 mm is recommended. thermal properties of materials and alignment of the insert holes. The purpose of this homogenous measurement zone is to cover various sensor constructions. With this in mind. for example. Related uncertainty is caused. • Axial uniformity Axial uniformity refers to the variation in temperature along the vertical length of the insert. • Radial uniformity Radial uniformity refers to the variation in temperature between the holes of the insert.total uncertainty of temperature calibration MAIN PARTS OF THE DRY BLOCK Stem conductance Sensor to be calibrated Reference sensor Axial uniformity Internal sersor Radial uniformity Uncertainty components that are related to temperature calibration are relevant to all manufacturers’ dry blocks.
it should be estimated or evaluated. If some component has not been specified. As the probe constructions vary greatly (sheet material. • Stability over time – Stability describes how well the temperature remains the same during a given time. when the system has reached equilibrium. to use immersion depth of 20 x the diameter. Sufficient immersion depth and dual zone control helps to reduce load-related uncertainties. the more the ambient temperature will affect the measurements. The Euramet calibration guide states that the immersion depth should be at least 15 x the probe’s outer diameter. Stability describes how well the temperature remains the same during a given time.). lead wire thermal conductivity etc. wall thickness. 152 . To minimize the stem conduction error it’s recommended. The loading effect is not visible in the control sensor indication and the controller cannot completely compensate for this shift. The hysteresis is greatest at the mid-point and is proportional to the temperature range. – The Euramet calibration guide defines stability as a temperature variation over a 30-minute period. The specifications for the above uncertainty components should be in the block’s specifications. The more the load. • Immersion Sufficient immersion is important in any temperature measurement. then the uncertainty caused by the insufficient immersion should be estimated/ evaluated. as a rule of thumb. • Hysteresis Hysteresis causes the internal sensor to be dependent on its previous exposure. a test for each individual probe type to be calibrated should be made. This means that the temperature of the dry block may be a bit different depending on the direction from which the set point is approached. plus the length of the sensing element. If sufficient recommended immersion cannot be reached.total uncertainty of temperature calibration • Loading effect Every probe in the insert conducts heat either from or into the insert.
153 . The internal sensor has to deal with quick temperature changes. the reference probe can be drawn out to match the immersion. mechanical robustness is usually inversely proportional to good performance: stability. In many cases. Of course. • Radial uniformity Radial uniformity is still present when using an external reference probe and should be taken into account as specified. the stem conductance has to be taken into account. vibration and possible mechanical shocks so it has to be quite a robust mechanically. Unfortunately. the external reference sensor is within the same calibration volume as the sensors to be calibrated. hysteresis. the following uncertainty components should be taken into account: • Axial uniformity A xial uniformity-related uncertainty can be minimized by aligning the centers of the sensing elements. the external reference enables more accurate measurement of the temperature of the probes to be calibrated. In case the probe to be calibrated is short and won’t reach the measurement zone at the bottom of the insert. The loading effect is usually much less significant with an external reference sensor. Therefore. In the case of using an external reference sensor. If the reference sensor and the sensor to be calibrated are sufficiently similar in diameter and thermal conductivity. The internal sensor is used just to adjust temperature close to the desired calibration point and keep it stable. the user can reduce the axial uniformity well below specification. etc. Using an external reference sensor enables more accurate measurement of the temperature of the probes to be calibrated.total uncertainty of temperature calibration Using an external reference sensor as reference Unlike using the dry block’s internal sensor as a reference. It helps to minimize calibration uncertainty but also provides reliability in measurements. • Loading effect Since the internal sensor cannot completely compensate the load related temperature shift inside the insert. There are many advantages to using a separate reference sensor. the user may obtain good results. the external reference sensor is inside the insert together with the probes to be calibrated. Using an external reference sensor enables smaller total uncertainty of the system.
stem conduction. hysteresis. 154 . using an external reference does not automatically mean better results. drift. for instance. All of the previously mentioned uncertainty factors need to be carefully considered.total uncertainty of temperature calibration • Stability over time The external reference sensor can be used to measure the actual temperature deviation inside the insert. – Uncertainty related to the reference probe components includes the probe’s calibration uncertainty. The external reference sensor can be used to measure the actual temperature deviation inside the insert and it also helps the user to see when the unit has truly stabilized. However. • External reference sensor – The external reference sensor (PRT) is typically much more capable of producing accurate measurements than the internal sensor. the external reference sensor needs a unit that measures the sensor. – Of course. there may still be some difference between the block and the insert temperatures when the indicator shows the unit has stabilized. It also helps the user to see when the unit has truly stabilized. the different loads. and the readout device’s uncertainty. Dry blocks usually have a stability indicator. but depending on. and it may often be smaller than the specification. It can be the block or an external device.
012 0.006 0. MB155R with internal measurement @0 °C Component Display Accuracy Hysteresis Axial Uniformity Radial Uniformity Stability Loading Effect Specification (°C) 0.003 0.total uncertainty of temperature calibration CALCULATION EXAMPLES ■ Here are two examples of total uncertainty calculations. One is done using the internal temperature measurement and the other with a reference probe.029 0.025 0.010 0. Due to the rectangular probability distribution of the specifications.006 Combined Uncertainty: Expanded Uncertainty: Reference Sensor (Beamex RPRT-420) Component Short-term repeatability Drift Hysteresis Calibration uncertainty Specification (°C) 0.01 0. In both cases the MB155R is used as the dry block. The various uncertainty components used in the examples can be found in the specifications in the product brochures. The standard uncertainties are combined as the root sum of the squares.02 0. That is why they are divided by the square root of three to get Standard Uncertainty.058 0.05 Combined Uncertainty: Expanded Uncertainty: Standard Uncertainty (°C) 0.006 0.007 0.005 0.017 0. 155 .01 0.003 0.034 Standard Uncertainty (°C) 0. The temperature in both examples is 0 °C.003 0.10 0. they are divided by the square root of three to get the Standard Uncertainty.135 MB155R with external measurement @0 °C Component Axial Uniformity Radial Uniformity Stability Loading Effect Ref sensor measurement Specification (°C) 0.005 0.014 0.01 0. Finally the combined uncertainty has been multiplied by two to get the expanded uncertainty.01 Combined Uncertainty: Expanded Uncertainty: MB155R and RPRT-420 Combined uncertainty: Expanded Uncertainty: 0.020 Standard Uncertainty (°C) 0.007 0.02 0.012 0.004 0.006 0.004 0.006 0.028 All specifications have a rectangular probability distribution.014 0.005 0.003 0.067 0.034 °C).135 °C). As can be seen in the examples the total expanded uncertainty using the internal reference sensor is 135 mK (0. When using an external reference sensor the total expanded uncertainty is 34 mK (0.
History of fieldbus Back in the 1940s. the mA signal was introduced. During the 1960s. Each transmitter needs a dedicated pair of cables. and I/O subsystems are required to convert the analog mA signal to a digital format for a control system. A standard was finally set in the year 2000 when the IEC61158 standard was approved. computerized control systems began to make their arrival. The Fieldbus transmitters must be calibrated as well. Several transmitters can be connected to the same pair of wires. manufacturers battled to see whose fieldbus would be the one most commonly used. In the 1970s. smart transmitter was introduced in the 1980s. The first fieldbus was introduced in 1988. but how can it be done? Conventional transmitters can deliver only one simultaneous parameter. The first digital. using first proprietary protocols. higher-level fieldbus backbone. Conventional I/O systems are no longer needed because segment controllers connect the instrument segments to the quicker. making things much easier. Fieldbus transmitters are able to deliver a huge amount of information via the quick two-way bus. instruments from any manufacturer can be connected to the same fieldbus as plug-and-play. Being an open standard. instrumentation utilized mainly pneumatic signals to transfer information from transmitters. one way. But what is fieldbus and how does it differ from conventional instrumentation? Fieldbus transmitters must be calibrated as well. but how can it be done? 157 .fieldbus transmitters must also be calibrated Fieldbus transmitters must also be calibrated F ieldbus is becoming more and more common in today’s instrumentation. and throughout the 1990s a number of various fieldbuses were developed. During the 1990s.
one can say that the Foundation Fieldbus is dominating the North American markets and the Profibus is the market leader in Europe. Another big advantage is the on-line self-diagnostics that helps in predictive maintenance and eventually reduces the downtime. were chosen as standards. There are also certain applications that prefer certain fieldbus installations despite the geographical location. Recent co-operation between Foundation Fieldbus and Profibus suppliers will further strengthen the position of these two standards. Critical applications and hazardous areas have also begun to adopt fieldbus. both used in process instrumentation. if it would not offer them benefits compared to alternative systems. A large portion of new projects is currently being carried out using fieldbus. Both Foundation Fieldbus and Profibus have reached such a large market share that both buses will most likely remain also in the future. and no need for conventional I/O subsystems. Fieldbus benefits for industry Obviously process plants would not start utilizing fieldbus. One important reason is the better return on investment. a large number of fieldbus installations already exist and the number is increasing at a huge rate. Although fieldbus hardware may cost the same as conventional. There are also other advantages compared to conventional instrumentation. The development of new fieldbuses has slowed down and it is unlikely that new fieldbus standards will appear in the near future to challenge the position of Foundation Fieldbus or Profibus. Other areas are more divided. lower installation labour cost.fieldbus transmitters must also be calibrated Foundation Fieldbus H1 and the Profibus PA. The improved system performance is important criteria for some plants. the total installation costs for a fieldbus factory is far less than conventional. Future of fieldbus Currently. For the most part. The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus markets. 158 . The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus market. offering maintenance savings. less planning/drawing costs. such as reduction in field wiring. or even a little bit more. Remote configuration also helps to support reduced downtime. This is caused by many reasons.
such as quality systems and regulations. “calibration” is often used to mean the configuration of a transmitter. it is not possible to calibrate a fieldbus transmitter remotely. The other parts of a fieldbus transmitter are mainly comparable to conventional or HART transmitters. Also. In fieldbus terminology. 159 .fieldbus transmitters must also be calibrated Fieldbus transmitters must also be calibrated The main difference between a fieldbus transmitter for pressure or temperature and conventional or HART transmitters is that the output signal is a fully digital fieldbus signal. the total installation costs for a fieldbus factory is far less than conventional. Naturally these two people need to communicate with each other in order to perform and document the calibration. Changing the output signal does not change the need for periodic calibration. In terminology pertaining to metrology. you can have one person in the field to provide and measure the transmitter input while another person is in the control room reading the output. In some cases you can use a portable fieldbus communicator or a laptop computer with dedicated software and hardware. Although fieldbus hardware may cost the same as conventional. When fieldbus is up and running. or even a little bit more. So it is not possible to calibrate a fieldbus transmitter using only a configurator or configuration software. that make the periodic calibrations compulsory. The input is measured with a traceable calibrator. Calibrating fieldbus transmitters The word “calibration” is often misused in the fieldbus terminology when comparing it to the meaning of the word in metrology. it does not eliminate the need for calibration. Reading the digital output is not always an easy thing to do. you need to find other ways to read the transmitter’s output. While your fieldbus and process automation systems are idle. There are also many other reasons. but you also need to have a way to read the output of the fieldbus transmitter. Fieldbus transmitters are calibrated in very much the same way as conventional transmitters – you need to place a physical input into the transmitter and simultaneously read the transmitter output to see that it is measuring correctly. “calibration” means that you compare the transmitter to a traceable measurement standard and document the results. Although modern fieldbus transmitters have been improved compared to older transmitter models.
There is no need for an additional communicator.fieldbus transmitters must also be calibrated Fieldbus instruments are increasing in popularity and calibration can in many cases be cumbersome. The Beamex® MC6 can be used as a communicator for the configuration as well as a calibrator for the calibration of smart instruments with the supported protocols. The calibration results can be automatically stored into the memory of the MC6 or uploaded to calibration software. The Beamex® MC6 will help to overcome these challenges by combining a full field communicator and an extremely accurate multifunctional process calibrator. The Beamex® MC6 can be used as a communicator for the configuration as well as a calibrator for the calibration of smart instruments with the supported protocols. time-consuming and may require an abundance of resources. 160 .
These new smart instruments bring new challenges to the calibration and configuration processes. the Beamex® MC6 –Advanced Field Communicator and Calibrator. in order for a transmitter to be called smart. that will help to overcome these challenges. Engineers can A modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. etc. the digital communication protocol is the biggest difference compared to conventional transmitters. etc. produce diagnostics. Furthermore. In any case. for the engineers who need to configure and calibrate the transmitter. a modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. Generally.configuring and calibrating smart instruments Configuring and calibrating smart instruments S o called “smart” instruments are ever more popular in the process industry. The vast majority of delivered instruments today are smart instruments. There is no standardized technical definition for what smart really means in practice.) and generates an output signal proportional to the measured input. The term “smart” is more of a marketing term than a technical definition. What is a “smart” transmitter? A process transmitter is a device that senses a physical parameter (pressure. temperature. 163 . it will utilize a microprocessor and should also have a digital communication protocol that can be used for reading the transmitter’s measurement values and for configuring various settings in the transmitter. A microprocessorbased smart transmitter has a memory that can perform calculations. But what are these smart instruments and what is the best way to configure and calibrate them? Beamex has recently introduced a new revolutionary tool.
such as Foundation Fieldbus and Profibus.e. you will need to use some form of configuration device. no analog signal. but these seem to be fading out in popularity and favor is being given to protocols based on open standards because of the interoperability that they enable. a non-smart transmitter. That brings a whole new challenge .configuring and calibrating smart instruments no longer simply measure the output analog signal. 164 . Configuration of a smart transmitter refers to the setting of the transmitter parameters. would be a transmitter with a purely analog (or even pneumatic) output signal. The fieldbuses. typically also called a communicator. contain only a digital output. These parameters may include engineering unit. The most common transmitter protocol today is the HART (Highway Addressable Remote Transducer) protocol. Recently the HART protocol seems to be getting more boosts from the newest WirelessHART protocol. Since it also has the analog signal. sensor type. It is crucial to remember that although a communicator can be used for configuration.how can the digital output be read? Thinking of the opposite of a smart transmitter. The configuration needs to be done via the communication protocol. to support the selected protocol. it is not a reference standard and therefore cannot be used for metrological calibration. it is compatible with conventional installations. Configuration One important feature of a smart transmitter is that it can be configured via the digital protocol. Some are proprietary protocols of a certain manufacturer. This article will discuss “smart” transmitters. So in order to do the configuration. Foundation Fieldbus and Profibus are gaining a larger foothold on the process transmitter markets. etc. Smart transmitter protocols There are various digital protocols that exist among transmitters considered smart. i. including HART. Most of the protocols are based on open standards. A HART transmitter contains both a conventional analog mA signal and a digital signal superimposed on top of the analog signal. Foundation Fieldbus and Profibus PA protocols. WirelessHART. but they need to have the possibility to communicate with the transmitter and read the digital signal.
by using a calibrator. which can read the digital output. or to read the digital output signal (if it is used). calibration is a comparison of the device under test against a traceable reference instrument (calibrator) and documenting the comparison. be a very challenging task. to see what the transmitter output is. with output being a digital protocol signal. be calibrated? Obviously the transmitter input still needs to be generated/measured the same way as with a conventional transmitter. it is not a reference standard and therefore cannot be used for metrological calibration. However. Wired HART (as opposed to WirelessHART) is a hybrid protocol that includes digital communication superimposed on a conventional analog 4–20mA output signal. or alternatively two separate singlefunction calibrators.e. by definition a traceable reference standard (calibrator) is always needed. Although the calibration formally does not include any adjustments. a device or software able to read and interpret the digital protocol is needed. Sometimes it is very difficult or even impossible to find a suitable device. analog transmitter. especially a mobile one. For a real metrological calibration. In this case calibration is quite easy and straight forward. it will automatically document the calibration results. 165 . But how can a smart transmitter.e. to do any configuration or trimming. but in order to see what the transmitter output is. To calibrate a conventional. If the calibration is done with a documenting calibrator. The 4–20mA output signal of a wired HART transmitter is calibrated the same way as a conventional transmitter. several types of devices may be needed and several people to do the job. a HART communicator is needed. Configuring the parameters of a smart transmitter with a communicator is not in itself a metrological calibration (although it may be part of an adjustment/trim task) and it does not assure accuracy.configuring and calibrating smart instruments It is crucial to remember that although a communicator can be used for configuration. by using a calibrator. Calibration of a smart transmitter According to international standards. i. potential adjustments are often included when the calibration process is performed. therefore. you need a dual-function calibrator able to process transmitter input and output at the same time. you can generate or measure the transmitter input and at the same time measure the transmitter output. However. The transmitter input needs to be generated/ measured the same way as with a conventional transmitter. i. The calibration may. you will need some device or software able to read and interpret the digital protocol.
the smart transmitter’s input can be generated/ measured at the same time as reading the digital output. There are some other “smart” process calibrators on the market with limited support for different protocols. All required electronics are built-in. energy. About Beamex® MC6 Beamex® MC6 is an advanced. The MC6 is one device with five different operational modes. The usability and ease-of-use are among the main features of the MC6. which means that it is fast and easy to use. It has a large 5. Any additional communicator is therefore not needed. including power supply and required impedances for the protocols. the MC6 includes a full field communicator for HART. When it comes to configuration of the smart transmitters. a separate communicator is needed in any case.7" color touch-screen with a multilingual user interface. high-accuracy field calibrator and communicator. typically only for one protocol (mostly HART) and offering very limited support. With the Beamex® MC6. and you can carry less equipment in the field. ergonomic design and light weight make it an ideal measurement device for field use in various industries. oil and gas. the smart transmitter’s input can be generated/ measured at the same time as reading the digital output. Foundation Fieldbus and Profibus PA instruments. The Beamex® MC6 can be used both as a communicator for the configuration and as a calibrator for the calibration of smart instruments with the supported protocols. The MC6 also contains a full fieldbus communicator for HART. In practice. The results can be automatically stored into the memory of the MC6 or uploaded to calibration software. With the Beamex® MC6. such as the pharmaceutical. It offers calibration capabilities for pressure. The robust IP65-rated dustand water-proof casing. The operation modes are: meter. calibrator. Foundation Fieldbus H1 and Profibus PA protocols.configuring and calibrating smart instruments The solution The new Beamex ® MC6 is a device combining a full field communicator and an extremely accurate multifunctional process calibrator. service as well as the petrochemical and chemical industries. temperature and various electrical signals. The MC6 supports all of the protocol commands according to the transmitter’s device description file. 166 . food and beverage. WirelessHART.
environmental systems. A short summary of the main reasons include. enabling fully automated and paperless calibration and documentation. • To achieve high and consistent product quality and to optimize processes. In conclusion. 167 . data logger and Fieldbus communicator. • Safety reasons.employee safety as well as customer/patient safety. the output protocol of a transmitter does not change the fundamental need for calibration. • Even the best instruments and sensors drift over time. In addition. such as quality systems. Foundation Fieldbus and Profibus PA instruments. standards. The MC6 also contains a full fieldbus communicator for HART. • Environmental reasons. Why calibrate? A modern transmitter is advertised as being smart and extremely accurate and sometimes sales people tell you they don’t need to be calibrated at all because they are so “smart”. So why would you calibrate them? First of all. especially when used in demanding process conditions. • Regulatory requirements. • Economical reasons – any measurement having direct economical effect.configuring and calibrating smart instruments documenting calibrator. the MC6 communicates with Beamex® CMX Calibration Software. etc. safety systems. There are numerous reasons to calibrate instruments initially and periodically. the MC6 is more than a calibrator.
such as natural gas. pharmaceuticals. In addition. and in the home. For example. many materials and fluids used in seemingly “safe” industries are themselves flammable. oil refineries. combustible fuels. Improperly calibrating an instrument in this hazardous environment can be almost as dangerous. For example. pulp/paper. are used in all industries. in many locations. leaks. an external flame would not ignite the hydrocarbons. abnormal conditions. Therefore. However. food. Hydrocarbons and other flammable fluids are not limited to the petroleum and chemical industries. including agriculture. may pose hazards as well. water/ wastewater. 169 . hydrocarbons in mines. Even seemingly safe water treatment systems use combustible materials such as chlorine in their processes. This means that certain areas of a water treatment plant may well be considered hazardous. Similarly. retail. The materials and fluids used in some processes can be hazardous in the sense that they can ignite or explode. it is important for plants to examine their processes and identify hazardous locations so that the proper instruments are Many materials and fluids used in seemingly “safe” industries are themselves flammable. certain areas of food plants. and fluid accumulation may allow hydrocarbons to be present such that the flame could ignite the hydrocarbons with disastrous results. and chemical plants are flammable and are typically contained within vessels and pipes.calibration in hazardous environments Calibration in hazardous environments S triking a match in an environment that contains combustible gas is nothing short of dangerous – personal injury and property damage are likely consequences. power generation. If this were truly the case. universities. such as reactors that hydrogenate oils.
Adding the applicability of IS designs to various hazards in the previous table yields: Zone 0 ia Flammable material present continuously Zone 1 ia. Temperature classes limit the maximum surface temperature between 450˚C (T1) and 85˚C (T6). 170 . ib Flammable material present abnormally In addition. and maintained in accordance with practices that are appropriate for the hazard. ib Flammable material present intermittently Zone 2 ia.calibration in hazardous environments selected. the IS concept is to design the calibrator such that it limits the amount of energy available such that it cannot ignite a combustible gas mixture. and the protection concept applied. Groupings (IEC 60079-10) in order of decreasing ignition energy (with an example of a gas in the group) are: Intrinsic Safety (IS) is the most common protection concept applied to calibrators used in hazardous locations. In general. Group IIC Acetylene Group IIB+H2 Hydrogen Group IIB Ethylene Group IIA Propane The hazardous area classifications (IEC 60079-10) in order of decreasing frequency are: Zone 0 Flammable material present continuously Zone 1 Flammable material present intermittently Zone 2 Flammable material present abnormally Intrinsic Safety (IS) is the most common protection concept applied to calibrators that are used in hazardous locations. installed. Equipment requirements in hazardous locations Protection requirements for hazardous locations vary according to the type of material present. The intensity with which various vapors can combust is generally different. frequency of the hazard. a hot surface temperature on a device can cause ignition.
it is practical to remove these instruments and calibrate them on the workshop with a calibration test bench. current. The Beamex modular calibration system is a test bench and calibration system for workshops and laboratories that incorporates the functionality of the MC5 multifunction calibrator and can measure/generate additional parameters such as precision pressures. The Beamex multifunction IS-calibrators are portable and intrinsically safe and have modules that can accommodate wide ranges and many types of pressure. creates documentation.calibration in hazardous environments Beamex calibrators for hazardous locations are designed and certified for Ex ia IIC T4 hazards per the ATEX Directive and are applicable to all vapor hazards where a temperature class of 135˚C in a 50˚C ambient is acceptable. and other variables designed in hazardous locations are generally used to monitor and control the process. they can be used for the overwhelming majority of applications where a vapor hazard is present. but also automatically takes data. It not only alerts you when to calibrate. and frequency measurements. The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work. This software generally makes calibration work faster and easier and is designed to integrate into management systems such as SAP and Maximo. The ergonomic design and modular construction allow the user to select the necessary functions in a cost-effective manner. The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work. voltage. and tracks calibration history. This is usually not the case. there are calibrators that are specifically designed to operate safely in rugged environments and hazardous locations. temperature. thermocouple. RTD. pressure. Fortunately. 171 . which means that many instruments are calibrated in the field. Calibration solutions for hazardous locations Instruments designed to measure flow. pulse. adheres to GMP regulations (21 CFR 11). In some applications. As such. level.
172 . stores. • Portable Beamex calibrators for hazardous locations are designed to be used in virtually all vapor hazards. and in the home. • Hazardous locations can exist in virtually all industries. installed. and maintained in accordance with requirements for the hazardous location.calibration in hazardous environments A few points to remember • Improper actions in hazardous locations can result in property damage and bodily injury. • Instruments should be specified. Hazardous locations can exist in virtually all industries. and in the home. operated. stores.
calibration in hazardous environments 173 .
such as oil refineries. such as gases. intrinsically safe fieldbus calibrators enter into the picture. mists. vapors or combustible dust. An intrinsically safe calibrator is therefore designed to be incapable of causing ignition in the surrounding environment with flammable materials. intrinsic safety (IS) is a protection technique for safely operating electronic equipment in explosive environments. Zone 2: an explosive gas & air mixture is not likely to occur in normal operation. Intrinsically safe calibrators are designed for potentially explosive environments. a flammable substance and oxygen. An Ex Area also refers to an explosive environment and an Ex calibrator is a device designed for use in the type of environment in question. The concept has been developed for safely operating process control instrumentation in hazardous areas. or “IS calibrators”. Intrinsically safe calibrators are also often referred to being “Ex calibrators”. By definition. When safety becomes a top priority issue in calibration. The idea behind intrinsic safety is to make sure that the available electrical and thermal energy in a system is always low enough that ignition of the hazardous atmosphere cannot occur. Zone 1: an explosive gas & air mixture is likely to occur in normal operation. but also safely. gas Hazardous area classifications in IEC/ European countries are: Zone 0: an explosive gas & air mixture is continuously present or present for a long time. “calibrators for Ex Areas”. There are also industrial environments where the calibration of fieldbus instruments should not only be made accurately and efficiently. Where is intrinsically safe calibration required? Many industries require intrinsically safe calibration equipment. A hazardous atmosphere is an area that contains elements that may cause an explosion: source of ignition. and if it occurs it will exist only for a short time. 175 .the safest way to calibrate fieldbus instruments The safest way to calibrate fieldbus instruments F ieldbus transmitters must also be calibrated just like conventional instruments. rigs and processing plants.
which should be read carefully before using the device. Basically. Basically. the calibrators provide performance and functionality. They can be used for calibration of pressure. it is the safest possible technique. Are intrinsically safe calibrators technically different from regular industrial calibrators? Intrinsically safe calibrators are different from other industrial calibrators in both design and technical features.IS. Safest possible technique Intrinsically safe calibrators are safe for employees. provides additional efficiency improvements with its seamless communication with calibration software. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. A documenting intrinsically safe calibrator. What are the benefits of using intrinsically safe calibrators? There are clear benefits in using intrinsically safe calibration equipment. This eliminates the need of manual recording of calibration data and improves the quality and productivity of the entire calibration process. The product safety note lists all the “do’s and don’ts” for safe calibration. Performance and functionality Multifunctional intrinsically safe calibrators provide the functionality and performance of regular industrial calibration devices. First of all. In addition. such as the Beamex® MC5. as well as pharmaceutical plants. intrinsically safe calibrators are the only technique permitted for Zone 0 environments (explosive gas and air mixture is continuously present or present for a long time). Secondly. as they can be safely used in environments where the risk of an explosion exists. temperature and electrical signals. there are also some guidelines and constraints for how to use them in hazardous areas. In view of safety. petrochemical and chemical plants.the safest way to calibrate fieldbus instruments pipelines and distribution centres. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. 176 . but in a safe way. Every intrinsically safe calibrator is delivered with a product safety note.
. it must be done in a non-Ex area. but they must also be intrinsically safe. The battery of an intrinsically safe calibrator is usually slower to charge and it discharges quicker. IEC (International Electrotechnical Commission) is a nonprofit international standards organization that prepares and publishes international standards for electrical technologies. Companies in the EU where the risk of explosion is evident must also use the ATEX guidelines for protecting the employees. quicker to discharge • Battery must be charged in a non-Ex area • When using external pressure modules. ATEX 95 equipment directive 94/9/EC concerns equipment intended for use in potentially explosive areas. There are also usually small differences with electrical ranges compared to regular industrial calibrators (e. 177 The differences in design and technical features were made with one purpose in mind – to ensure that the device is safe to use and is unable to cause an ignition. The surface of the device is made of conductive material. In addition. 2003. but the Beamex intrinsically safe calibrators operate with chargeable batteries. while maintaining the required level of safety. the ATEX rules are obligatory for electronic and electrical equipment that will be used in potentially explosive atmospheres sold in the EU as of July 1.g. IECEx is an international scheme for certifying procedures for equipment designed for use in explosive atmospheres. maximum is lower). maximum is lower) • Battery slower to charge. The objective of the IECEx Scheme is to facilitate international trade in equipment and services for use in explosive atmospheres. The IEC TC/31 technical committee deals with the standards related to equipment for explosive atmospheres. External pressure modules can be used with IS-calibrators.g. they must be IS-versions What are ATEX and IECEx? ATEX (“ATmosphères EXplosibles”. explosive atmospheres in French) is a standard set in the European Union for explosion protection in the industry. Many times intrinsically safe equipment operate only with dry batteries. Making a calibrator safe and unable to cause ignition – typical technical differences: • Surface made of conductive material • Constraints in using the device (listed in Product Safety Note) • Small differences with electrical ranges (e. When charging the battery.the safest way to calibrate fieldbus instruments The differences in design and technical features were made with one purpose in mind—to ensure that the device is safe to use and is unable to cause an ignition.
temperature. electrical and frequency signals. The MC5-IS can also be used for calibrating Foundation Fieldbus H1 or Profibus PA transmitters. Recalibration can be done by calibration laboratories (still preferably with ISO/IEC 17025 accreditation). The MC5-IS also has HART communication.the safest way to calibrate fieldbus instruments As Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is certified according to ATEX and the IECEx Scheme. Being an all-in-one calibrator. Is service different for intrinsically safe calibrators? There are certain aspects that need special attention when doing service or repair on an intrinsically safe calibrator. all-in-one calibrator for extreme environments. it ensures the calibrator is fit for its intended purpose and that sufficient information is supplied with it to ensure that it can be used safely. The MC5-IS has calibration capabilities for pressure. The best way to do this is to send it to the manufacturer or to an authorized service company for repair. It is a documenting calibrator. which means that it communicates seamlessly with calibration software. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. the MC5-IS replaces many individual measurement devices and calibrators. The MC5-IS is also ATEX and IECEx certified. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. Safe fieldbus calibration with the Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator The Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is a high accuracy. Using documenting calibrators with calibration software can remarkably improve the efficiency and quality of the entire calibration process. 178 . The MC5-IS also has HART communication.
The Metrology Handbook. The technical definitions may be different from the definitions published in common grammar dictionaries. and other publications. If a word is defined in a technical standard. not to standardize the way the words should be used. Definitions of these words are in relevant national. Jay L. However. as well as publications of relevant technical and professional organizations. Many of these definitions are adapted from the references. international and industry standards. NCSL Glossary. 2004.appendix: calibration terminology a to z 1 Calibration terminology A to Z 1 T his glossary is a quick reference to the meaning of common terms. the purpose of common dictionaries is to record the ways that people actually use words. In technical. In technical work. 181 . journals. Bucher. GUM. and the information in the other references listed at the end. Those documents give the intended meaning of the word. scientific and engineering work (such as metrology) it is important to correctly use words that have a technical meaning. In some cases several may be merged to better clarify the meaning or adapt the wording to common metrology usage. It is a supplement to the VIM. ______________ 1. so everyone in the business knows what it is. its definition from a common grammar dictionary should never be used in work where the technical standard can apply. only the technical definitions should be used. Milwaukee: ASQ Quality Press.
CO: NCSL International. 1999. IEC. with the documented measurement parameters and their best uncertainties. NCSL. S. (It is assumed that a calibration or metrology activity owns copies of these as part of its basic reference material.appendix: calibration terminology a to z 1 Terms that are not in this glossary may be found in one of these primary references: 1. Accreditation certificate – Document issued by an accreditation body to a laboratory that has met the conditions and criteria for accreditation. IFCC. Accreditation includes evaluation of both the quality management system and the competence to perform the measurements listed in the scope. Some terms may be listed in this glossary in order to expand on the definition. but should be considered an addition to the references listed above. ANSI/NCSL. NCSL Glossary of metrology-related terms.5) Because the true value is always unknown. 3. IUPAC. 3. accuracy of a measurement is always 182 . Boulder. 1997. U. ANSI/NCSL Z540-2-1997. BIPM. ISO. Geneva: ISO. ISO. (VIM. CO: NCSL International. Accreditation body – An organization that conducts laboratory accreditation evaluations in conformance to ISO Guide 58. Guide to the expression of uncertainty in measurement (called the GUM). The certificate. 1993. Accreditation criteria – Set of requirements used by an accrediting body that a laboratory must meet in order to be accredited. Boulder. 2nd ed. IUPAP. Accuracy (of a measurement) – Accuracy is a qualitative indication of how closely the result of a measurement agrees with the true value of the parameter being measured. not a replacement of them. 2. and OIML.) Glossary Accreditation (of a laboratory) – Formal recognition by an accreditation body that a calibration or testing laboratory is able to competently perform the calibrations or tests listed in the accreditation scope document. serves as proof of accredited status for the time period listed. An accreditation certificate without the documented parameters is incomplete. International vocabulary of basic and general terms in metrology (called the VIM).
realize. An accuracy statement by itself has no meaning other than as an indicator of quality. systematic error Calibration – (1).18) Accuracy is a design specification and may be verified during calibration. conserve. compensates for the bias. 5. See also: correction. Contrast with: accuracy (of a measuring instrument) Accuracy (of a measuring instrument) – Accuracy is a qualitative indication of the ability of a measuring instrument to give responses close to the true value of the parameter being measured. (VIM. which is always the negative of the bias. Calibration is performed with the item being calibrated in 183 .25) The value and direction of the bias is determined by calibration and/or gage R&R studies. It is the process of verifying the capability and performance of an item of measuring and test equipment by comparison to traceable measurement standards. (See VIM 6. 5.) Calibration is a term that has many different – but similar – definitions.11 and NCSL pages 4–5 for primary and secondary definitions. Bias – Bias is the known systematic error of a measuring instrument.appendix: calibration terminology a to z 1 an estimate. or when performing more-or-less routine calibrations of nearly ideal measuring instruments designed for the measurement of that quantity. (VIM.” (EA-4/02) The best measurement capability is based on evaluations of actual measurements using generally accepted methods of evaluating measurement uncertainty. Contrast with: accuracy (of a measurement) Application – Software installed on a defined platform/hardware providing specific functionality Assessment – Examination typically performed on-site of a testing or calibration laboratory to evaluate its conformance to conditions and criteria for accreditation. the best measurement capability for a particular quantity is “the smallest uncertainty of measurement a laboratory can achieve within its scope of accreditation when performing more or less routine calibrations of nearly ideal measurement standards intended to define. It has quantitative value only when accompanied by information about the uncertainty of the measuring system. or reproduce a unit of that quantity or one or more of its values. Adding a correction. Bespoke/Customized computerised system – A computerised system individually designed to suit a specific business process Best measurement capability – For an accredited laboratory.
or artifacts as needed to verify the performance. or is otherwise in an indeterminate state. calculation of correction factors or adjustment of the instrument being compared to reduce the magnitude of the inaccuracy. may be included as part of the calibration.appendix: calibration terminology a to z 1 its normal operating configuration – as the normal operator would use it. measurement standards. Calibration is performed according to a specified documented calibration procedure. report. The calibration process consists of comparing an IM&TE unit with specified tolerances. and with a specified and controlled measurement system. determining or assigning one or more values. • The calibration process may include. minor repair such as replacement of batteries. This may be in the form of a pass/fail decision. See also: performance test. • Calibration does not include any maintenance or repair actions except as just noted. or lamps. • In some cases. or minimize by adjustment any deviations from the tolerance limits or any other variation in the accuracy of the instrument being compared. calibration procedure Contrast with: calibration (2) and repair Calibration – 2 A) Many manufacturers incorrectly use the term calibration to name the process of alignment or adjustment of an item that is either newly manufactured or is known to be out of tolerance. The calibration process uses traceable external stimuli. or minor adjustment such as zero and span. under a set of specified and controlled measurement conditions. to a measurement system or device of specified capability and known uncertainty in order to detect. Calibration provides assurance that the instrument is capable of making measurements to its performance specification when it is correctly used. or the determination of one or more corrections. fuses. Many calibration procedures in manufacturers’ manuals are actually factory alignment procedures that only need to be performed if a UUC is in an indeterminate state because it is being manufactured. 184 . if necessary. but of unverified accuracy. Notes: • A requirement for calibration does not imply that the item being calibrated can or should be adjusted. The result of a calibration is a determination of the performance quality of the instrument with respect to the desired specifications.
or any combination or variation of these. A calibration certificate should provide other information to allow the user to judge the adequacy and quality of the calibration. a certificate often refers to the permanent record of the final result of a calibration. the organization presenting the certificate. or an industry-specific name. Examples include performing a selftest as part of normal operation or performing a self-calibration (normalizing) a measurement system before use. When calibration is used to refer to tasks like this. It may be external or internal. including subsidiary operations of a larger entity. A laboratory database certificate is a record that cannot be changed. or after it is repaired. calibration means the same as alignment or adjustment. the intent is that they are part of the normal work done by a trained user of the system. shop. if it is amended later a new certificate is created. IM&TE instruction manuals may use calibration to describe tasks normally performed by the operator of a measurement system. and the effective date. The certificate identifies the item calibrated. self-calibration. or department. which are repair activities and excluded from the metrological definition of calibration. (2) In a laboratory database program. a metrology laboratory or department. standardization Calibration activity or provider – A laboratory or facility – including personnel – that perform calibrations in an established location or at customer location(s). a means to record 185 . Calibration certificate – (1) A calibration certificate is generally a document that states that a specific item was calibrated by an organization. These and similar tasks are excluded from the metrological definition of calibration. (B) In many cases. It may be called a calibration laboratory. See also: calibration report Calibration procedure – A calibration procedure is a controlled document that provides a validated method for evaluating and verifying the essential performance characteristics. It provides a list of recommended calibration standards to use for the calibration.appendix: calibration terminology a to z 1 is known to be out of tolerance. specifications. or tolerances for a model of measuring or testing equipment. A calibration procedure documents one method of verifying the actual performance of the item being calibrated against its performance specifications. When used this way. Contrast with: calibration (1) See also: normalization.
or label that. Calibration report – A calibration report is a document that provides details of the calibration of an item. clearly indicates tampering. Calibration program – A calibration program is a process of the quality management system that includes management of the use and control of calibrated inspection.13. and 6. and the process of calibrating IM&TE used to determine conformance to requirements or used in supporting activities. 6. artifact. A calibration procedure always starts with the assumption that the unit under test is in good working order and only needs to have its performance verified.appendix: calibration terminology a to z 1 quantitative performance data both before and after adjustments. A calibration program may also be called a measurement management system (ISO 10012:2003). and information sufficient to determine if the unit being calibrated is operating within the necessary performance specifications. In addition to the basic items of a calibration certificate.14. 6. when removed or tampered with. placard. The purpose of a calibration seal is to ensure the integrity of the calibration. Calibration standards generally have lower uncertainty and better resolution than general-purpose items. See also: calibration certificate Calibration seal – A calibration seal is a device. and test and measuring equipment (IM&TE). Note: A calibration seal may also be referred to as a tamper seal. Note: A calibration procedure does not include any maintenance or repair actions. and the actual measurement results and uncertainty.) A calibration standard is an IM&TE item. As calibration standards are used to calibrate other IM&TE items. they are more closely controlled and characterized than the workload items they are used for. Designation as a 186 . and NCSL pages 36–38. A calibration seal is usually imprinted with a legend similar to “Calibration Void if Broken or Removed” or “Calibration Seal – Do Not Break or Remove.” A calibration seal provides a means of deterring the user from tampering with any adjustment point that can affect the calibration of an instrument and detecting an attempt to access controls that can affect the calibration of an instrument. a calibration report includes details of the methods and standards used.9.1 through 6. the parameters checked. standard reference material. or measurement transfer standard that is designated as being used only to perform calibrations of other IM&TE items. and by virtue of its design and material. Calibration standard – (See VIM.
the confidence interval is: p (1 – p) s CI = x ¯ ± t = ––– or CI = p ± ––––––––– n n where CI is the confidence interval.appendix: calibration terminology a to z 1 calibration standard is based on the use of the specific instrument.3. x is the sample mean. For example. standard deviations. 2. Confidence interval – A range of values that is expected to contain the true value of the parameter being evaluated with a specified level of confidence. 187 . whose fitness for use is demonstrated by a broad spectrum of users. lines. since it is a synonym and has more accepted usage in the United States. Note: The word qualification is sometimes used in the personal sense. weighted according to how the measurement result varies with changes in those quantities. the demonstrated ability to apply knowledge and skills. not on any other consideration. The confidence interval is calculated from sample statistics. (GUM. in a group of identical instruments. slopes. For an infinite (or very large compared to the sample) population. and t is the Student’s T value for α ⁄2 and (n – 1) (α is the level of significance). n is the number of items in the sample. For a person. See also: standard (measurement) Combined standard uncertainty – The standard uncertainty of the result of a measurement. Calibration standards are often called measurement standards. The terms are the variances or covariances of these other quantities. Confidence intervals can be calculated for points. the demonstrated ability to perform the tests or calibrations within the accreditation scope and to meet other criteria established by the accreditation body. Competence – For a laboratory. one might be designated as a calibration standard while the others are all general purpose IM&TE items. It is equal to the positive square root of a sum of terms. when that result is obtained from the values of a number of other quantities. and so on. p is the proportion of items of a given type in the population.4) See also: expanded uncertainty Commercial of the shelf software – Software commercially available. s is the sample standard deviation. however.
Departure value – A term used by a few calibration laboratories to refer to bias. The exact meaning can usually be determined from examination of the calibration certificate. and/or accredited organizations within the host country. It is usually given the value 2.10. error (or measurement error) is an estimate of the difference between the measured value and the probable true value of the object of the measurement. 3. (GUM.14. 3. documented determination that a specific instrument or type of instrument is suitable for use in place of the one originally listed. systematic error Gage R&R – Gage repeatability and reproducibility study. including actions taken to prevent reoccurrence of the nonconformance. accreditation bodies. correction (of error). Error (of measurement) – (See VIM. The error can never be known exactly. which 188 .appendix: calibration terminology a to z 1 Correction (of error) – A correction is the value that is added to the raw result of a measurement to compensate for known or estimated systematic error or bias. Error may be systematic and/or random. (B) A formal.6) The coverage factor is identified by the symbol k. it is always an estimate.12–3. Deficiency – Nonfulfillment of conditions and/or criteria for accreditation. for a particular application. random error. which approximately corresponds to a probability of 95 percent for degrees of freedom > 10’. random error. Equivalence – (A) Acceptance of the competence of other national metrology institutes (NMI). See also: bias. error. Compare with: preventive action Coverage factor – A numerical factor used as a multiplier of the combined standard uncertainty in order to obtain an expanded uncertainty. sometimes referred to as a nonconformance. See also: bias.15) Any residual amount is treated as random error.) In metrology. Systematic error (also known as bias) may be corrected. and/or accredited organizations in other countries as being essentially equal to the NMI. and NCSL pages 11–13. error or systematic error. An example is the value calculated to compensate for the calibration difference of a reference thermometer or for the calibrated offset voltage of a thermocouple reference junction.3. accreditation body. (VIM. 2. systematic error Corrective action – Corrective action is something done to correct a nonconformance when it arises. The correction value is equal to the negative of the bias. 3.
pressure. In the United States. or SPETE (special purpose electronic test equipment). U. or after a process. PMET (precision measuring equipment and tooling). Internal audit – A systematic and documented process for obtaining audit evidence and evaluating it objectively to verify that a laboratory’s operations comply with the requirements of its quality system. The mission of ISO is “to promote the development of standardization and 189 . Guide to the Expression of Uncertainty in Measurement. the equivalent document is ANSI/NCSL Z540-2-1997. PME (precision measuring equipment). IM&TE – The acronym IM&TE refers to inspection. measuring. and measurements over a period of time to capture quantitative observations. The data captured are analyzed statistically to obtain best measurement capability. personnel. GUM – An acronym commonly used to identify the ISO Guide to the Expression of Uncertainty in Measurement. measurements. The number of instruments. so it is a first-party audit. Switzerland. and length of time are established to be statistically valid consistent with the size and level of activity of the organization. Some organizations do not include instruments used solely to check for the presence or absence of a condition (such as voltage. TMDE (test. S. Note: Organizations may refer to IM&TE items as MTE (measuring and testing equipment). performance. personnel. International Organization for Standardization (ISO) – An international nongovernmental organization chartered by the United Nations in 1947. IM&TE items are typically used in applications where the measurement results are used to determine conformance to technical or quality requirements before. with headquarters in Geneva. This term includes all items that fall under a calibration or measurement management program. and test equipment. and so on) where a tolerance is not specified and the indication is not critical to safety.appendix: calibration terminology a to z 1 (typically) employs numerous instruments. Interlaboratory comparison – Organization. and diagnostic equipment). and evaluation of tests or calibrations on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions. GPETE (general purpose electronic test equipment). An internal audit is done by or on behalf of the laboratory itself. during. which is expressed as an uncertainty with a coverage factor of k = 2 to approximate 95 percent. measuring.
Effectively. and luminous intensity. formal. ISO – Iso is a Greek word root meaning equal. and to developing cooperation in the spheres of intellectual. 2. thermodynamic temperature.) The name also symbolizes the mission of the organization – to equalize standards worldwide. (The acronym SI is from the French Systéme International. The SI system is popularly known as the metric system. operation. periodic. France. (VIM. Life cycle – All phases in the life of the system from initial requirements until retirement including design. The International Organization for Standardization chose the word as the short form of the name. programming. so it will be a constant in all languages. industry and commerce except electrical and electronic engineering. (The United States is represented by ANSI. In this context. and maintenance.appendix: calibration terminology a to z 1 related activities in the world with a view to facilitating the international exchange of goods and services. which makes it possible for the application to function. time. amount of substance.) SI is international system of measurement for all physical quantities. specification. testing.) See also: ISO International System of Units (SI) – A defined and coherent system of units adopted and used by international treaties. installation. IT Infrastructure – The hardware and software such as networking software and operation systems.” The scope of ISO’s work covers all fields of business. (If the acronym was based on the full name were used. technological and economic activity. and p is the coverage probability or level of confidence of the interval. Measurement – A set of operations performed for the purpose of determining the value of a quantity. (Mass.) SI units are defined and maintained by the International Bureau of Weights and Measures (BIPM) in Paris. length. Management review – The planned. it would be different in each language. scientific. ISO is not an acronym. The members of ISO are the designated national standards bodies of each country. the coverage level expressed as a percent. and scheduled examination of the status and adequacy of the quality management system in relation to its quality policy and objectives by the organization’s top management. electric current.1) 190 . Level of confidence – Defines an interval about the measurement result that encompasses a large fraction p of the probability distribution characterized by that result and its combined standard uncertainty.
For example. Mobile operations may include work from an office space. methods. or commerce. and the base of natural logarithms (e). the ratio of a circle’s circumference to its diameter (p). or the use of a virtual office. commercial and government facilities around the world. education. whose membership is open to any organization with an interest in the science of measurement and its application in research. and the reference junction itself is also in the ice point. associated materials and accessories. the personnel. NCSL was formed in 1961 to “promote cooperative efforts for solving the common problems faced by measurement laboratories. Natural constants are used in the basic theoretical descriptions of the universe. home. people. industrial. conditions.2). Any value other than zero is an offset created by inhomogeneity of the thermocouple wires combined 191 . scientific. instrument calibration. if the thermocouple alloy leads of a reference junction probe are formed into a measurement junction and placed in an ice point cell.appendix: calibration terminology a to z 1 Measurement system – A measurement system is the set of equipment. the gravitational constant (G). Normalize – See: self-calibration Offset – Offset is the difference between a nominal value (for an artifact) or a target value (for a process) and the actual measured value.” Normalization. NCSL promotes technical and managerial excellence in the field of metrology. the triple point of water (273. the procedures used. Metrolog y – Metrology is the science and practice of measurement (VIM. Examples of natural physical constants important in metrology are the speed of light in a vacuum (c). vehicle. the quantum charge ratio (h/e). and other quantifiable factors that combine to determine the success of a measurement process. 2. NCSL has member organizations from academic. development. The measurement system includes at least the test and measuring instruments and devices. NCSL international – Formerly known as the National Conference of Standards Laboratories (NCSL). NCSL is a nonprofit organization.16 K). Natural (physical) constant – A natural constant is a fundamental value that is accepted by the scientific community as valid. and test and measurement. Mobile operations – Operations that are independent of an established calibration laboratory facility. measurement standards. then the theoretical thermoelectric emf measured at the copper wires should be zero. and the physical environment.
See also: procedure Precision – Precision is a property of a measuring system or instrument. Preventive action helps improve the system. Compare with: bias. See also: policy Process owner – The person responsible for the business process. goals. 192 . There may be more than one procedure for a given policy. A procedure has more detail than a policy but less detail than a work instruction. while others may only have a few general guidelines. Policy statements relevant to the quality management system are generally stated in the quality manual. A performance test is done with the item in its normal operating configuration. A policy describes what management intends to have done regarding a given portion of business activity. 3.5) Preventive action – Preventive action is something done to prevent the possible future occurrence of a nonconformance. Contrast with: corrective action Procedure – A procedure describes a specific process for implementing all or a portion of a policy. (NCSL. A performance test is the same as a calibration (1). or general management position on a specific topic. (VIM. This includes climate-controlled mobile laboratories. but actually perform the calibration actions at customer locations. Policies can also be in the organization’s policy/procedure manual. page 26) Precision is not the same as accuracy. vision. even though such an event has not yet happened. error On-site operations – Operations that are based in or directly supported by an established calibration laboratory facility. Precision is a measure of the repeatability of a measuring system – how much agreement there is within a group of repeated measurements of the same quantity under the same conditions. Some policies may be implemented by fairly detailed procedures. See also: calibration (1) Policy – A policy defines and sets out the basic objectives.appendix: calibration terminology a to z 1 with other uncertainties. Calibration: see calibration procedure. Performance Test – A performance test (or performance verification) is the activity of verifying the performance of an item of measuring and test equipment to provide assurance that the instrument is capable of making correct measurements when it is properly used. The level of detail needed should correlate with the level of education and training of the people with the usual qualifications to do the work and the amount of judgment normally allowed to them by management.
The quality manual is generally provided to customers on request. The instrument is opened. Quality manual – The quality manual is the document that describes the quality management policy of an organization with respect to a specified conformance standard. it does not usually contain any detailed policies and never contains any procedures. Passing the calibration test indicates success of the repair. In addition to its regular use by the organization. or replacing one or two in-stock components. The need for repair may be indicated by the results of a calibration. Passing 193 . See also: error Compare with: systematic error Repair – Repair is the process of returning an unserviceable or nonconforming item to serviceable condition. minor repair is always followed by calibration of the item. repair is always followed by calibration of the item. or is removed from its case and may be disassembled to some degree. Random error – Random error is the result of a single measurement of a value. or repairing a broken wire. 3. auditors use the quality manual when they audit the quality management system. Random error is usually evaluated by Type A methods. For calibratable items. or proprietary information. therefore. The quality manual briefly defines the general policies as they apply to the specified conformance standard and affirms the commitment of the organization’s top management to the policy. the GUM specifically does not replace random error with either Type A or Type B methods of evaluation. Examples include replacement of batteries. For calibratable items. Contrast with: calibration (1). or has covers removed.13) Random error causes scatter in the results of a sequence of readings and. (VIM. minus the mean of a large number of measurements of the same value. Note: Contrary to popular belief. Repair includes adjustment or alignment of the item as well as component-level repair. repair (minor) Repair (minor) – Minor repair is the process of quickly and economically returning an unserviceable item to serviceable condition by doing simple work using parts that are in stock in the calibration lab. (Some minor adjustment such as zero and span may be included as part of the calibration. or lamps. Therefore. is a measure of dispersion. but Type B methods are also used in some situations.appendix: calibration terminology a to z 1 Proficiency testing – Determination of laboratory testing performance by means of interlaboratory comparisons. or minor cleaning of switch contacts. fuses. work instructions.) The need for repair may be indicated by the results of a calibration.
• Deviation from the nominal (or reference) value and uncertainty. uncertainty. The uncertainty is usually expanded uncertainty as defined in the GUM. or calibrations and their best measurement. Minor repairs are defined as repairs that take no longer than a short time as defined by laboratory management. The scope document is an attachment to the certificate of accreditation and the certificate is incomplete without it. repair Reported value – One or more numerical results of a calibration process. and where no parts have to be ordered from external suppliers. or once per shift. and where substantial disassembly of the instrument is not required. The specific type and format vary according to the type of measurement being made. with the associated measurement uncertainty. the scope is a documented list of calibration or testing fields. In general. or week of continuous operation.appendix: calibration terminology a to z 1 the calibration test indicates success of the repair. The process may be required at intervals such as every power-on sequence. as recorded on a calibration report or certificate. The uncertainty of the deviation is usually expanded uncertainty as defined in the GUM. Self-calibration – Self-calibration is a process performed by a user for the purpose of making an IM&TE instrument or system ready for use. The reported value is usually the mean of a number of repeat measurements. parameters. • Estimated systematic error and uncertainty. The value may be reported this way when it is known that the instrument is part of a measuring system and the systematic error will be used to calculate a correction that will apply to the measurement system results. The reported value is the difference between the nominal value and the mean of a number of repeat measurements. day. and only the listed areas may be offered as accredited calibrations or tests. Contrast with: calibration (1). or if the ambient temperature changes by a specified 194 . The accreditation body usually defines the format and other details. most reported values will be in one of these formats: • Measurement result and uncertainty. Only the calibration or testing areas that the laboratory is accredited for are listed in the scope document. specific measurements. Round robin – See: Interlaboratory Comparison Scope of accreditation – For an accredited calibration or testing laboratory.
appendix: calibration terminology a to z 1 amount. a specification is a documented statement of the expected performance capabilities of a large group of substantially identical measuring instruments. given in terms of the relevant parameters and including the accuracy or uncertainty. or scrapping. or the methods for evaluation of any of these. repair. The value and uncertainty of the standard define a limit to the measurements that can be made: a laboratory can never have better precision or accuracy than its standards. the process may be performed totally by the instrument or may require user intervention and/or use of external calibrated artifacts. or material that is used as a defined basis for making quantitative measurements. calibration standard. reference standard. a national standard that describes the requirements for the quality management system of a calibration organization and the requirements for calibration and management of the measurement standards used by the organization. a norme) is a document that describes the processes and methods that must be performed in order to achieve a specific technical or management objective. Once initiated. Items with similar uses in a production shop are generally regarded as working-level instruments by the calibration program. if an instrument requires self-calibration before use. Standard (document) – A standard (industry. government.B) Contrast with: calibration (1) Specification – In metrology. Customers use specifications to determine the suitability of a product for their own applications. Selfcalibration may also be called normalization or standardization. or international standard. laboratory standard. Accepted as having the highest metrological 195 . An example is ANSI/NCSL Z540-11994. then that will also be accomplished at the start of a calibration procedure. Self-calibration is not equivalent to periodic calibration (performance verification) because it is not performed using a calibration procedure and does not meet the metrological requirements for calibration. national. Compare with: calibration (2. The usual purpose is accuracy enhancement by characterization of errors inherent in the measurement system before the item to be measured is connected. device. Primary standard. instrument. Also. A product that performs outside the specification limits when tested (calibrated) is rejected for later adjustment. Measurement standards are generally used in calibration laboratories. an étalon) is a system. Standard (measurement) – A standard (measurement standard. artifact.
Systematic error is also called bias when it applies to a measuring instrument.appendix: calibration terminology a to z 1 qualities and whose value is accepted without reference to other standards of the same quantity. Note: Contrary to popular belief. Standard reference material – A standard reference material (SRM) as defined by NIST “is a material or artifact that has had one or more of its property values certified by a technically valid procedure.” Standard uncertainty – The uncertainty of the result of a measurement. A standard that is used for routine calibration of IM&TE. A device used to transfer the value of a measurement quantity (including the associated uncertainty) from a higher level to a lower level standard. Transfer standard. procedures. or work instructions. 3. (VIM. correction (of error) Compare with: random error 196 . (3.3. SRMs represent one of the primary vehicles for disseminating measurement technology to industry. or traceable to. Secondary standard. Also called a reference standard. error.3. note) See also: bias. the GUM specifically does not replace systematic error with either Type A or Type B methods of evaluation. (GUM. are the realizations or representations of SI units. The highest level standards. according to the type of data available. Systematic error may be evaluated by Type A or Type B methods. Systematic error is a measure of magnitude and may be corrected. Working standard.2. The highest accuracy level standards in a particular laboratory generally used only to calibrate working standards. Examples: triple point of water cell and caesium beam frequency standard.14) Systematic error causes the average of the readings to be offset from the true value. 2.1) Standardization – See: self-calibration. See also: calibration standard Standard operating procedure (SOP) – A term used by some organizations to identify policies. expressed as a standard deviation. a certificate or other documentation which is issued by NIST… Standard reference materials are…manufactured according to strict specifications and certified by NIST for one or more quantities of interest. and is accompanied by. Systematic error – A systematic error is the mean of a large number of measurements of the same value minus the (probable) true value of the measured parameter. found in national and international metrology laboratories.
A tolerance is a property of the item being measured. Test accuracy ratio – (1) In a calibration procedure. Tolerances are applied during design and manufacturing. they must be converted to absolute values of the basic measurement units. or another ratio. the test accuracy ratio (TAR) is the ratio of the accuracy tolerance of the unit under calibration to the accuracy tolerance of the calibration standard used. Compare with: specification. Note: The uncertainty of a measurement standard is not necessarily the same as its accuracy specification. or another ratio. page 2) TAR = UUT_tolerance STD_tolerance The TAR must be calculated using identical parameters and units for the UUC and the calibration standard. Third Party – Parties Tolerance – A tolerance is a design feature that defines limits within which a quality characteristic is supposed to be on individual parts. (NCSL. If the accuracy tolerances are expressed as decibels. uncertainty 197 . the test uncertainty ratio (TUR) is the ratio of the accuracy tolerance of the unit under calibration to the uncertainty of the calibration standard used. (2) In the normal use of IM&TE items. page 2) TUR = UUT_tolerance STD_uncert The TUR must be calculated using identical parameters and units for the UUC and the calibration standard. If the accuracy tolerances are expressed as decibels. it represents the maximum allowable deviation from a specified value. Test uncertainty ratio – In a calibration procedure. Note: TAR may also be referred to as the accuracy ratio or (incorrectly) the uncertainty ratio. percentage.appendix: calibration terminology a to z 1 System owner – The person responsible for the availability. the TAR is the ratio of the tolerance of the parameter being measured to the accuracy tolerance of the IM&TE. percentage. (NCSL. and maintenance of a computerised system and for the security of the data residing on that system. they must be converted to absolute values of the basic measurement units.
6. That number is merely a catalog number of the specific service provided by NIST to a customer so it can be identified on a purchase order.10) Traceability is a demonstrated or implied property of the result of a measurement to be consistent with an accepted standard within specified limits of uncertainty. (VIM. Transfer standard – A transfer standard is a measurement standard used as an intermediate device when comparing two other standards. or industry or other accepted consensus reference standards. 6. providing the ability to relate the measurement result to stated references. (NCSL. and singlevalue standard resistors. or from a secondary standard to a working standard in order to create or maintain measurement traceability. Examples of typical transfer standards are DC volt sources (standard cells or zener sources). Only the result of a specific measurement can be said to be traceable. through an unbroken chain of comparisons each having stated uncertainties. but the report alone is not sufficient. Transfer measurement – A transfer measurement is a type of method that enables making a measurement to a higher level of resolution than normally possible with the available equipment. Evidence of traceability includes the calibration report (with values and uncertainty) of calibration standards.appendix: calibration terminology a to z 1 Traceable. provided all of the conditions just listed are met. a measurement system. fundamental or physical natural constants that are reproducible and have defined values. traceability – Traceability is a property of the result of a measurement. capacitors. (VIM. The laboratory must also apply and use the data. Common transfer methods are differential measurements and ratio measurements. pages 42–43) The stated references are normally the base or supplemental SI units as maintained by a national metrology institute. certified standard reference materials. Traceability provides the ability to demonstrate the accuracy of a measurement result in terms of the stated reference. 198 . A calibration laboratory. or any other thing is not and be traceable to a national standard. from a primary standard to a secondary standard. ratio type comparisons. A calibration system operating under a program controls system only implies traceability. a calibration report. or inductors.8) Typical applications of transfer standards are to transfer a measurement parameter from one organization to another. Measurement assurance methods applied to a calibration system include demonstration of traceability. Reference to a NIST test number is specifically not evidence of traceability. a calibrated IM&TE.
range of measurement. the result is a value with a calculated uncertainty. which are used in the text of the calibration procedure for convenience. After an item that has a specified tolerance has been calibrated using an instrument with a known accuracy. UUT – The unit under calibration or the unit under test – the instrument being calibrated.3.2. These are standard generic labels for the IM&TE item that is being calibrated.appendix: calibration terminology a to z 1 Type A evaluation (of uncertainty) – Type A evaluation of measurement uncertainty is the statistical analysis of actual measurement results to produce uncertainty values. Also may be called device under test (DUT) or equipment under test (EUT). (GUM. Type B evaluation Uncertainty budget – The systematic description of known uncertainties relevant to specific measurements or types of measurements. Total uncertainty may consist of components that are evaluated by the statistical probability distribution of experimental data or from assumed probability distributions based on other data. 3.3. effects that contribute to the dispersion may be random or systematic. 2. methods.5) Data for evaluation by Type B methods may come from any source believed to be valid. Both random and systematic error may be evaluated by Type A methods. and/ or other applicable measurement criteria. Verification – Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. and/or procedures are fit for their intended use.3. UUC.3 through 3. categorized by type of measurement. (GUM.3 through 3.5) Uncertainty can only be evaluated by Type A methods if the laboratory actually collects the data. Validation – Substantiation by examination and provision of objective evidence that verified processes. See also: Type A evaluation. with a specified level of confidence. Uncertainty – Uncertainty is a property of a measurement result that defines the range of probable values of the measurand. 3.3. Uncertainty is an estimate of dispersion. Type B evaluation (of uncertainty) – Type B evaluation of measurement uncertainty includes any method except statistical analysis of actual measurement results.3) Uncertainty is an estimate of the range of values that the true value of the measurement is within. Both random and systematic error may be evaluated by Type B methods. (GUM. VIM – An acronym commonly used to identify the ISO International 199 .
a calibration procedure is a type of work instruction. Work instructions are used only where they are needed to ensure the quality of the product or service. The Metrology Handbook. The level of education and training of the people with the usual qualifications to do the work must be considered when writing a work instruction.appendix: calibration terminology a to z 1 Vocabulary of Basic and General Terms in Metrology. Milwaukee: ASQ Quality Press. 200 . Bucher. In a metrology laboratory. 2004.) Work Instruction – In a quality management system. (The acronym comes from the French title. 1. Jay L. a work instruction defines the detailed steps necessary to carry out a procedure.
PORTABLE CALIBRATORS WORKSTATIONS PROFESSIONAL SERVICES CALIBRATION SOFTWARE 202 .
manufacturing.about beamex About Beamex • One of the world’s leading providers of calibration solutions. database conversion. workstations. Help Desk and re-calibration services available. professional services and industryspecific solutions. Integrated calibration solutions Beamex calibrators. contractor engineering. calibration software. They are all delivered with a traceable. • Comprehensive product range includes portable calibrators.000 companies worldwide utilize Beamex’s calibration solutions. accessories. ease-of-use and reliability. efficiency. metal and mining. Why is Beamex better Accuracy assured Accuracy is assured when you decide to purchase a Beamex® calibrator. petrochemical and chemical. High customer satisfaction Constantly improving understanding of customer needs and developing solutions to meet them. Support Installation. and pulp and paper. automated system. pharmaceutical. nuclear. oil and gas. aviation. system integration. food and beverage. such as automotive. power and energy. i. accredited calibration certificate. • Customers from wide range of industries. Industry pioneer with global presence A forerunner in developing high-quality calibration equipment and software. More than 10. calibration software and professional services form an integrated. education. systems and services for the calibration and maintenance of process instruments. marine. software. • Certified in accordance with the ISO 9001:2008 quality standard. 203 . International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum Inc. workstations. • Products and services available in more than 60 countries. training. • Develops and manufactures high-quality calibration equipment. validation. versatility. with global customer base and partner network. (IAF). FINAS is a member of all Multilateral Recognition Agreements / Mutual Recognition Arrangements (MLA/MRA) signed by European and other international organizations. • Beamex’s Accredited Calibration Laboratory is accredited and approved by FINAS (Finnish Accreditation Service). European co-operation for Accreditation (EA).e. • For customers with requirements for accuracy.