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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
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 .Contents Preface by the CEO of Beamex Group 7 QUALITY.
foreword 6 .
The new topics covered in the edition mainly discuss paperless calibration. This book is the 2nd edition of Ultimate Calibration. Presently. and calibration of smart instruments. Enjoy your reading! raimo ahola. Beamex aims to be the benchmark in the industry. and how to lower the risk of human errors. I would like to thank all of the people who have contributed to this book. I hope this book will assist you in learning new things and in providing fresh. On behalf of Beamex. A team of experts in industry and calibration worldwide has put forth effort to its creation. stand-alone devices. new ideas. Just like any other business function. intelligent commissioning. This book is the result of work that has taken place between 2006 and 2012. All of these challenges can be tackled by improving the level of system integration and automation. Calibration and calibrators can no longer be considered as isolated. In this area. how to reduce production down-time. how to eliminate double work. 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. who was the key person in organizing and leading the project for the 2nd edition. I want to express my special thanks to Pamela at Beamex Marketing. calibration procedures need to be automated to a higher degree and integrated to achieve improvements in quality and efficiency. the primary challenges of industrial metrology and calibration include how to simplify and streamline the entire calibration process. beamex group 7 . systems or work processes within a company or production plant.preface by the ceo of beamex group Preface C alibrators. ceo. 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. temperature calibration and configuring.
Regulations and Traceability .Quality.
but reason. 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 . Lord Kelvin). PRS. GCVO. 1215) When you can measure what you are speaking about and express it in numbers.1 One of the earliest records of precise measurement is from Egypt. Surely it is the better part of thought that relies on measurement and calculation.K. and there shall be standard weights also. you know something about it. A. the Egyptian unit of length came into being. The Republic. 360 B.C. (Clause 35. PC. It is believed that about 3000 years B. and a standard width of dyed russet and cloth.C. but you have scarcely. and corn… throughout the whole of our kingdom. The Egyptians studied the science of geometry to assist them in the construction of the Pyramids. but when you cannot express it in numbers. 1st Baron Kelvin. and the clerk of the scales.) There shall be standard measures of wine. 26 June 1824–17 December 1907. these drive vague notions of greater or less or more or heavier right out of the minds of the surveyor. (William Thomson.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. here is a reminder from times past about measurement practices and how important they really are. OM. Magna Carta. in your thoughts. beer. is beautifully restored by measuring. thus confused by false appearance. (Plato. your knowledge is of a meager and unsatisfactory kind.. the computer. It may be the beginning of knowledge.A. numbering and weighing. advanced to the stage of science. Immersion in water makes the straight seem bent.
05%.quality standards and industry regulations finger plus the width of the palm of the hand of the Pharaoh or King ruling at that time. The biggest difference between the two is simple – ISO standards are voluntary. In Europe. etc. there are basically two types of requirements: ISO standards and regulatory requirements. and regulatory requirements are mandatory. traceability and calibration recall. they are inspected by government inspectors for compliance to federal regulations. In roughly 756 feet or 230. The need for calibration has been around for at least 5000 years. 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.5 inches or 11. The Royal Architect or Foreman of the construction site was responsible for maintaining & transferring the unit of length to workers instruments. 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. They were required to bring back their cubit sticks at each full moon to be compared to the Royal Cubit Master. they were within 4.2 The “Royal Cubit Master” was carved out of a block of granite to endure for all times. the Egyptians had anticipated the spirit of the present day system of legal metrology. detailed information for achieving regulatory compliance is provided in Eudralex . 12 . were supplied with cubits made of wood or granite. 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). In the case of ISO standards. However. temples.36276 meters. standards. Thousands of workers were engaged in building the Great Pyramid of Giza.43 centimeters. the Egyptians achieved surprising accuracy.Volume 4 of “The rules governing medicinal products in the European Union”. they achieved an accuracy of 0. On the other hand. if a company is manufacturing a drug that must meet regulatory requirements. In today’s calibration environment. 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. Workers engaged in building tombs. pyramids. With this standardization and uniformity of length. If an organization volunteers to meet ISO 9000 standards. Failure to do so was punishable by death. Through the use of cubit sticks.
Subpart B – Quality System Requirements § 820. S. Subpart D – Document Controls § 820.75 – Process validation.1 – Scope. Subpart E – Purchasing Controls § 820. § 820.3 – Definitions. § 820. § 820.30 – Design controls. measuring. Subpart C – Design Controls § 820.25 – Personnel. and what they say about calibration and what must be accomplished to meet the CFRs. Subpart G – Production and Process Controls § 820. Food and Drug Administration (FDA) Following are examples of some of the regulations required by the FDA. Please note that European standards are similar to FDA requirements.40 – Document controls. § 820. § 820. Subpart F – Identification and Traceability § 820. and test equipment. 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 § 820.72 – Inspection.quality standards and industry regulations Calibration requirements according to the U.22 – Quality audit. § 820. Listed below are several different parts of 21CFR.50 – Purchasing controls.65 – Traceability.60 – Identification.20 – Management responsibility.70 – Production and process controls.5 – Quality system. 13 . § 820. that relate to the calibration of test equipment in different situations and environments.
and finished device acceptance.250 – Statistical techniques. Subpart O – Statistical Techniques § 820. § 820. § 820.90 – Nonconforming product.140 – Handling. Storage. in-process.200 – Servicing. § 820.170 – Installation.80 – Receiving.160 – Distribution.184 – Device history record. Subpart J – Corrective and Preventive Action § 820.181 – Device master record. and Installation § 820.186 – Quality system record.100 – Corrective and preventive action. Subpart L – Handling. Subpart N – Servicing § 820. § 820. § 820.quality standards and industry regulations Subpart H – Acceptance Activities § 820.150 – Storage.86 – Acceptance status. § 820. § 820. [Code of Federal Regulations] [Title 21.198 – Complaint files. Volume 8] [Revised as of April 1. § 820.120 – Device labeling.72] TITLE 2 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H – MEDICAL DEVICES 14 . Subpart K – Labeling and Packaging Control § 820. Subpart I – Nonconforming Product § 820. 2012] [CITE: 21CFR820. § 820. Subpart M – Records § 820. Distribution.130 – Device packaging.180 – General requirements.
automated. When accuracy and precision limits are not met. 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. and test equipment. These activities shall be documented. Each manufacturer shall ensure that all inspection. the manufacturer shall use an independent reproducible standard. the individual performing each calibration. is suitable for its intended purposes and is capable of producing valid results. inspected.72 Inspection. Calibration standards used for inspection. and storage of equipment. 820. (b) Calibration. If no applicable standard exists. preservation. so that its accuracy and fitness for use are maintained. (2) Calibration records. including mechanical. Calibration procedures shall include specific directions and limits for accuracy and precision. or electronic inspection and test equipment. and test equipment shall be traceable to national or international standards. measuring. and the next calibration date shall be documented. and test equipment. If national or international standards are not practical or available. These activities shall be documented. the manufacturer shall establish and maintain an in-house standard. The equipment identification.quality standards and industry regulations PART 820–QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls Sec. 15 . Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated. measuring. (a) Control of inspection. calibration dates. measuring. and test equipment. checked. The procedures shall include provisions for handling. (1) C alibration standards. measuring. and maintained. 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 holding of a drug product. including computers. drug product containers. 211. closures. mechanical. quality.quality standards and industry regulations [Code of Federal Regulations] [Title 21. in-process materials.68 Automatic. and electronic equipment. or related systems that will perform a function satisfactorily. and test procedures designed to assure that components. mechanical. strength. Laboratory controls shall include: (1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components. closures. may be used in the manufacture. labeling. sampling plans. drug product containers. (b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications. Written records of those calibration checks and inspections shall be maintained. packing. 211. it shall be routinely calibrated. 16 . 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. or electronic equipment or other types of equipment. and drug products conform to appropriate standards of identity.160 General requirements. processing. Volume 4] [Revised as of April 1. Sec. standards. inspected. If such equipment is so used. and purity. or checked according to a written program designed to assure proper performance. (a) Automatic.
29. gauges. (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. 2008] Sec. 1978. limits for accuracy and precision. and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments. [43 FR 45077. drug product container. Sept. Samples shall be representative and adequately identified. as amended at 73 FR 51932. and recording devices not meeting established specifications shall not be used. apparatus. Such samples shall be representative and properly identified. and recording devices at suitable intervals in accordance with an established written program containing specific directions. The specifications shall include a description of the sampling and testing procedures used. Sept.194 Laboratory records. schedules. 8. Such procedures shall also require appropriate retesting of any component.quality standards and industry regulations and labeling used in the manufacture. (4) The calibration of instruments. gauges.160(b)(4). and recording devices required by 211. apparatus. gauges. apparatus. or holding of drug products. (d) Complete records shall be maintained of the periodic calibration of laboratory instruments. processing. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. packing. or closure that is subject to deterioration. 17 . 211. Such samples shall be representative and properly identified.
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. cleaning and sanitation.g. equipment and systems.29 There should be written policies. • Technology transfer.31 Logbooks should be kept for major or critical analytical testing. • Internal quality/GMP compliance audits. • Summaries of records where appropriate (e. • Environmental monitoring. • Maintenance. for the following examples: • Validation and qualification of processes. clothing and hygiene and verification of the effectiveness of training. 4. 22 . procedures. • Equipment assembly and calibration. any use of the area. • Change control. maintenance. as appropriate. • Recalls. training in GMP and technical matters. production equipment. reports and the associated records of actions taken or conclusions reached. • Returns. • Complaints. They should be used to record in chronological order. product quality review). protocols. • Personnel matters including signature lists. • Investigations into deviations and non-conformances. • Pest control. where appropriate. equipment/method. • Supplier audits. and areas where product has been processed. including the dates and identity of people who carried these operations out. calibrations.quality standards and industry regulations Procedures and records Other 4.
• data from environmental monitoring. (c) icalibration requirements. • validation records of test methods.quality standards and industry regulations Chapter 6 Quality Control Good Quality Control Laboratory Practice Documentation 6. • sampling procedures. • testing procedures and records (including analytical worksheets and/ or laboratory notebooks). where required. Installation qualification (IQ ) should be performed on new or modified facilities. 23 . IQ should include. 12. An important part of this documentation deals with Quality Control and the following details should be readily available to the Quality Control Department: • specifications. but not be limited to the following: (a) installation of equipment. where applicable. services and instrumentation checked to current engineering drawings and specifications. • analytical reports and/or certificates. piping. (d) verification of materials of construction. Annex 15 to the EU Guide to Good Manufacturing Practice Title: Qualification and validation QUALIFICATION Installation qualification 11. systems and equipment. (b) icollection and collation of supplier operating and working instructions and maintenance requirements. • procedures for and records of the calibration of instruments and maintenance of equipment.7 Laboratory documentation should follow the principles given in Chapter 4.
systems and equipment 19. operating procedures and operator training procedures and records should be documented. (f) proposed in-process controls with acceptance criteria. but not be limited to the following: (a) short description of the process. systems and equipment. Prospective validation should include. (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. operator training and preventative maintenance requirements. as appropriate. The completion of a successful Operational qualification should allow the finalisation of calibration. Additionally. (h) sampling plan. (i) methods for recording and evaluating results (j) functions and responsibilities. 24 . Qualification of established (in-use) facilities. PROCESS VALIDATION Prospective validation 24. (e) list of analytical methods. with acceptance criteria and analytical validation. It should permit a formal “release” of the facilities. (g) additional testing to be carried out. cleaning. (b) summary of the critical processing steps to be investigated. preventative maintenance.quality standards and industry regulations Operational qualification 15. (k) proposed timetable. the calibration. operating and cleaning procedures. as appropriate. Evidence should be available to support and verify the operating parameters and limits for the critical variables of the operating equipment.
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.quality standards and industry regulations EU GMP Annex 11 The EU GMP Annex 11 defines EU requirements for computerised systems.Volume 4 Good manufacturing practice (GMP) Guidelines: http://ec.htm PDF of Annex 11: http://ec.europa. This document provides guidance for the interpretation of the principles 25 .eu/health/documents/eudralex/vol-4/index_en. Main page for the EudraLex .pdf EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_ en.
A computerised system is a set of software and hardware components which together fulfill certain functionalities. 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. picscheme. Consequential amendments are also proposed for Chapter 4 of the GMP Guide. B-1049 Bruxelles / Europese Commissie.org/. process control or quality assurance. 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.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. It aims to promote harmonisation of global regulations for the pharmaceutical industry. Where a computerised system replaces a manual operation. Further information can be found at the PIC/S Web site (http://www.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. The application should be validated. There should be no increase in the overall risk of the process.). IT infrastructure should be qualified. 26 . B-1049 Brussel . Deadline for coming into operation: 30 June 2011 Commission Européenne.
Switzerland). They also bring the GAMP® community closer to its members.quality standards and industry regulations GAMP® GAMP® is a Community of Practice (COP) of the International Society for Pharmaceutical Engineering (ISPE). GAMP® Italiano and GAMP® Japan. This is the latest major revision and was released in January 2008. GAMP® Nordic. 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. Since 1994.A Companion Volume to GAMP® 5 • GAMP® Good Practice Guide: Electronic Data Archiving • GAMP® Good Practice Guide: Global Information Systems Control and Compliance 27 . GAMP® Japan. Austria. such as GAMP® Americas. and GAMP® Americas support the GAMP® Council which oversee the operation of the COP and is the main link to ISPE. the organization entered into a partnership with the ISPE and published its first GAMP® guidelines. GAMP® DACH (Germany. COPs provide networking opportunities for people interested in similar topics. GAMP® Europe. Three regional Steering Committees. produce technical content and translate ISPE technical documents. The GAMP® COP aims to provide guidance and understanding concerning GxP computerized systems. The GAMP® COP organizes discussion forums for its members and ISPE organises GAMP® related training courses and educational seminars. The most well known GAMP® publication is GAMP ® 5 A RiskBased Approach to GxP Computerized Systems. in collaboration with ISPE’s local Affiliates in these regions. Several local GAMP® COPs. GAMP® Francophone. There is also a series of related GAMP® guidance on specific topics. 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 .
and corrective actions vital to regulatory compliance. A set of associated attachments are also available through the ISPE website. it requires periodic calibration). this is what is required according to ISO 9001:2008 7. • Establish monitoring and measuring processes (calibration procedures and calibration record templates for recording your calibration results). The Guide describes the principles of calibration and presents guidance in setting up a calibration management system. and analytical instrumentation. documentation. calibration program management. and select test equipment that can meet those monitoring and measuring needs and requirements. ISO 9001:2008 Basically.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. • 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). The second edition of the guide has been significantly updated to address the change in regulatory expectations and in associated industry guidance documents. The scope now includes related industries. All calibrations must be traceable to a national or international standard or artifact. providing a structured approach to instrument risk assessment.6 CONTROL MONITORING AND MEASURING EQUIPMENT • Identify your organization’s monitoring and measuring needs and requirements (if your test instrument makes a quantitative measurement. 28 . laboratory.
this standard is applicable to all organizations performing tests and/or calibrations. rather it be for compliance to an ISO standard (ISO 9001:2008 or ISO 13485) or an FDA requirement (cGMP. QSR. • 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. your test instruments may need to be qualified prior to use).3-2006 ANSI/NCSL Z540. Please keep in mind that if your calibration function and/or metrology department fall under the requirements of your company. this is just as applicable when dealing with ISO as with any other standard or regulation. and laboratories where testing and/or calibration forms part of inspection and product certifications.). You already fall under a quality system that takes care of your calibration requirements. and may have affected numerous items of test equipment over a period of time).3-2006 – American National Standard for Calibration-Requirements for the Calibration of Measuring and Test Equipment. “When accuracy and precision limits are not met. and your calibration standards). preservation. ISO 17025 ISO 17025 – General requirements for the competence of testing and calibration laboratories. According to ISO 17025. These include first-. especially when the out of tolerance item is a calibration standard. etc. ANSI/NCSL Z540.quality standards and industry regulations • Protect your monitoring and measuring equipment (this includes during handling. second-. and when required. and shipping of all test instruments – to include your customer’s items. transportation. and third-party laboratories. then you do not have any obligation to meet the ISO 17025 standard. 29 . 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”. • Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out-ofcalibration (as stated in the FDA regulations. storage.
and other evaluations of calibration systems and their components. • the compatibility of measurements with the National Measurement System. and • assessment organizations in the audit. Reference to this National Standard may be made by: • customers when specifying products (including services) required. Part 11 of ANSI/NCSL Z540. • the suitability of a calibration for its intended application. each term being interpreted in the broadest sense. • applying best practices and experience with related national. • suppliers when specifying products offered. The “Supplier may be a producer. or information.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. and government standards. • agencies or organizations as a contractual condition for procurement. and • balancing the needs and interests of all stakeholders. This National Standard is written for both Supplier and Customer. vendor. In addition. enduser. or purchaser that receives a product or service.1 (R2002) and Military Standard 45662A. retailer. international. In implementing its objective. or a provider of a product. Collectively. The “Customer” may be a consumer. distributor. this National Standard describes the technical requirements for establishing and maintaining: • the acceptability of the performance of measuring and test equipment. 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. this National Standard includes and updates the relevant calibration system requirements for measuring and test equipment described by the previous standards. certification. service. client. 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. 30 . This is done through the use of a system of functional components. and • the traceability of measurement results to the International System of Units (SI). industry. • legislative or regulatory bodies.
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.
Measurements made by R&D are different than those made by the operations section. Babies are not correctly weighed at birth. has found the cure for cancer. 35 . the cure for cancer is one of them. Incorrect amounts of ingredients in your prescription and over-the-counter (OTC) drugs can cost more. Airliners fly into mountaintops and off the ends of runways because they don’t know their altitude and/or speed. for food weighed incorrectly at the checkout counter. Because of poor or incorrect calibration. If all test equipment were calibrated to a traceable standard. Let’s imagine that the Acme Biotech Co. 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 cannot be replicated with consistent results. The company loses time. The amount of drugs confiscated in a raid determines whether the offense is a misdemeanor or a felony. Their R&D section sends the formula to their operations & manufacturing division. all of us pay more at the gas pump. Without calibration. having the correct measurements throughout any and all industries is critical to national and international trade and commerce. This scenario is repeated every day throughout the world. A fairy tale? Not hardly. money. and possibly the ability to stay in business simply because they do not use calibrated test equipment. or by using incorrect calibrations. and for manufactured goods that do not meet their stated specifications. their reputation. They are not using calibrated test instruments in the company. or even cause illness or death. criminals are either not convicted or are released on bad evidence. which weight is correct? As one can see. Crime labs cannot identify the remains of victims or wrongly identify victims in the case of mass graves.a basic quality calibration program A basic quality calibration program R &D departments are tasked with coming up with the answers to many problems.
Before we can get any deeper into what traceability is. one of known uncertainty (your standard) and one of unknown uncertainty (your test equipment or instrument). However. no matter the circumstances is called calibration. It is as simple as that. By definition: Calibration is a comparison of two measurement devices or systems. 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). the ‘everyday calibration technician’ is usually situated close to the bottom of the pyramid. According to the European cooperation for Accreditation of Laboratories. so a graphic illustration of these pyramids is important. but differ depending on where you are in the chain. let’s discuss the use of uncertainty budgets. First. we need to clarify two definitions that are critical to this subject – calibration and traceability. When we talk about traceability to a national or international standard. The two examples in figures 1 and 2 are similar.a basic quality calibration program The bottom line is this – all test equipment that make a quantitative measurement require periodic calibration. Many people are under the misconception that an item must be adjusted or aligned in order to be calibrated. Nothing could be further from the truth. the purpose of which is to give guidance on the calibration and maintenance of measuring 36 . The comparison to a standard that is more accurate. and that is why it is being calibrated). through an unbroken chain of calibrations all having stated uncertainties. or certain parts of the world. It does not make any difference if you adjust. publication reference (EAL-G12) Traceability of Measuring and Test Equipment to National Standards. nor if you cannot adjust or align it. align or repair the item. The calibration of any piece of equipment or system is simply a comparison between the standard being used (with its known uncertainty). before we go any further. usually national or international standards. we should explain two different traceability pyramids. and the unit under test (UUT) or test instrument that is being calibrated (the uncertainty is unknown. Traceability is the property of the result of a measurement or the value of a standard whereby it can be related to stated references.
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. 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. paragraphs 4 and 5 are very specific in their requirements: 4 Why are calibrations and traceability necessary? 4. 37 . and the EN 45001 standard for the operation of testing laboratories. must measure with the ‘same measure’.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. supplier firms that make products.
(e) reference to SI units. 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. way of use. 38 . the producer must be able to demonstrate. by reference to a systematic and fully documented system.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. frequency of use. the laboratories or bodies performing one or more steps in the chain must supply evidence for their technical competence. if they are used properly. usually a national or international standard. each step in the chain must be performed according to documented and generally acknowledged procedures. 4. uncertainty required. (c) documentation.g. is not affected by defects. the results must equally be documented.a basic quality calibration program 4. failure to meet these requirements means the absence of a warranted quality with considerable consequent liability. e. e.2 There are legal as well as technical reasons for traceability of measurement. was in proper working order and was used correctly for controlling a product. the length of these intervals will depend on a number of variables. calibrations must be repeated at appropriate intervals. 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. (b) measurement uncertainty. 4.1 Traceability is characterised by a number of essential elements: (a) an unbroken chain of comparisons going back to a standard acceptable to the parties. by demonstrating that they are accredited. 5 Elements of traceability 5. stability of the equipment.3 If it becomes necessary to prove absence of liability. (d) competence. Note: If binding requirements for the accuracy of measuring and test equipment have been stipulated. the chain of comparisons must end at primary standards for the realization of the SI units.g. that adequate measuring and test equipment was chosen. (f) re-calibrations.
if a TUR of equal to or greater than 4:1 is maintained. reference materials take the position of physical reference standards.” So. without using uncertainty budgets or calculations. to set up. 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. in addition to the general requirements of EAL-R1.a basic quality calibration program 5. Certification of reference materials is a method that is often used to demonstrate traceability to SI units. and uncertainty calculations were performed and their uncertainty stated on the certificate of calibration.32006) which states: “Where calibrations provide for verification that measurement quantities are within specified tolerances…Where it is not practical to estimate this probability.2 In many fields. the TUR shall be equal to or greater than 4:1. This is correct and acceptable. Keep in mind that a TUR of 4:1 somewhere along the chain of calibrations may not have been feasible. Where does this ratio of four to one (4:1) come from? It comes from the American National Standard for Calibration – (ANSI/NCSL Z540.1 The other document that goes hand-in-hand with this is EA 4/02. As the rules laid down in this document are in compliance with the recommendations of the Guide to the Expression of Uncertainty in Measurement. where the need to maintain a TUR of 4:1 comes into play. The purpose of this document is to harmonise evaluation of uncertainty of measurement within EA. where the customer’s test 39 . It is equally important that such reference materials are traceable to relevant SI units. To maintain traceability. Expression of the Uncertainty of Measurement in Calibration. you must ensure your standards are at least four times (4:1) more accurate than the test equipment being calibrated.2 By understanding and following both of these documents. In most circumstances. published by seven international organisations concerned with standardisation and metrology. the implementation of EA-4/02 will also foster the global acceptance of European results of measurement. then traceability is assured. is at the company or shop level. 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.
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. it is possible to initiate process improvements. This is applicable in every phase of a production and/or manufacturing program. 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. If a change has been made to that procedure. But especially true in a metrology department. They submit a change proposal for the calibration procedure and everyone is briefed and trained on the new technique. The four calibration technicians that have been following the calibration procedure improve their production and save the company money. Once stability and consistency are achieved. The effective operation of such a system will hopefully result in stable processes and. They have calibrated the same items for several years and feel there is nothing new to learn. One of the four calibration technicians (who are always following the calibration procedures) finds there is a fast.3 Let’s take for example a calibration program that has six calibration technicians on staff. The two ‘old timers’ have a reduction in their production and actually cost the company money. then this would not have happened. If everyone was using the calibration procedures like they were supposed to. However. therefore. Of course not.a basic quality calibration program equipment is usually used for production or manufacturing purposes only. 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. and the appropriate documentation completed to show that training 40 . But they must have their calibration procedure on hand each time they are performing the calibration. the calibration technician must be trained on the change before they can perform the calibration. 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. in a consistent output from those processes. more economical way to perform a specific calibration. Four of them work in another facility calibrating the same types of equipment as the other two.
“Record what you did” means that you must record the results of your measurements and adjustments. work instructions and SOPs. This includes calibration procedures. or upper/lower limits specified in your procedures or instructions.) and regulations throughout most industries that regulate or monitor production and manufacturing of all types of products. When the proper training is not documented and signed off by the trainer and trainee. or perform a function that follows specific written instructions. Record what you did. you’re required to inform the user/owner of the equipment because they may have to re-evaluate manufactured goods. This includes calibration procedures. One of the most stringent requirements can be found in the current Good Manufacturing Procedures (GMP). including what your standard(s) read or indicated both before and after any adjustments might be made. Do what you say. “Say what you do” means write in detail how to do your job. work instructions and standard operating procedures (SOPs).a basic quality calibration program was accomplished and signed off. etc. “Act on the difference” means if the test equipment is out of tolerance. and Act on the difference”. Let’s break these down into simple terms. All of your calibration procedures should be formatted the same as other SOPs within your company. Check the results. “Check the results” means make certain the test equipment meets the tolerances. change a process. The basic premise and foundation of a quality calibration program is to “Say what you do. then it is the same as if the training never happened. These items are also referred to by other standards (ISO 9000.3 “Say what you do” means write in detail how to do your job. Here is an example of common formatting for SOPs: 41 . accuracies. 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). or recall a product. “Do what you say” means follow the documented procedures or instructions every time you calibrate.
Definitions. micrometers. Responsibilities 4. Manufacturer’s manuals usually provide an alignment procedure that can be used as a template for writing a calibration procedure. and removes doubt by the calibration technician on what data goes into which data field. Possibly. A complete calibration must be performed prior to any adjustment or alignment. After that you should have a list of the standards to be used to calibrate the items. “Do what you say” means follow the documented procedures or instructions every time you calibrate. Related Procedures 7. Specific SOPs are written to show stepby-step procedures for each different type of test instrument within a group of items. pressure and vacuum gages. 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. two types of calibration procedures: Generic: temperature gages and thermometers. power supplies and water baths. There are. Specific: spectrophotometers. This table should also include the standard’s range and specifications. Have the latest edition of the procedure available for use by your calibration technicians. generally speaking. Forms and Records 8. Procedures. Generic SOPs are written to show how to calibrate a large variety of items in a general context.a basic quality calibration program 1. This means following published calibration procedures every time you calibrate a piece of test equipment. Procedures 2. Scope 3. along with their range and tolerances. Document History After section 4. pipettes. the calibration form is designed to follow specific steps (number wise). Procedure 6. or perform a function that follows specific written instructions. thermal cyclers. Definitions 5. Have a system in place for updating your 42 . They should show what standards accomplish the calibration of a specific range and/or function. and balances/scales. Then the actual calibration procedure starts in section 5. you should have a table listing all of the instruments or systems that would be calibrated by that procedure.
Excel. There should be a place to show what the standard read. What do you do when you need to make an improvement. prior to alignment. or update your calibration procedures and/or forms? A formal. their part number and range/tolerance.g. The date of calibration. Of course there are many ways to accomplish this. the last time it was calibrated. written process must be in place. as well as the test instrument’s ‘As Found’ and when applicable ‘As Left’ readings.a basic quality calibration program procedures. The location of where the test instrument can be found should also be on the record. 43 . e. Certain requirements must be documented in each calibration record. If an out-of-tolerance (OOT) condition is found. 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. A history of each calibration and a traceability statement or uncertainty budget must be included. The entire calibration is performed to see any part of the calibration is out of tolerance. The ‘As Found’ readings are what the test instrument read the first time that a calibration is performed. Train your technicians on the changes made to your procedures every time the procedure is changed or improved – and document the training. and the next time it will be due calibration should be on the form. including: • pen and paper • “do-it-yourself ” databases. including what your standard(s) read or indicated both before and after any adjustments are made. and keep your calibration records in a secure location. 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.
collecting the ‘As Left’ readings for the final calibration record. a final ‘As Left’ calibration would be performed. and the temperature standard is used to record the actual reading. In some circumstances. Then. and an ‘As Left’ set of data is collected. It just dies and cannot be calibrated. The calibration is performed. Another example would be when preventive maintenance inspection is going to be performed on an item. 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. “As Left” readings are taken after repair. an ‘As Found’ calibration is performed. This is a best practice policy that has been in use in the metrology community since calibration started. Usually. will also be recorded on the calibration form. If the item is found to be out-of-tolerance at that time. after the UUT is adjusted to be as close to optimum as possible. collecting the ‘As Found’ data. The water bath is set to a predetermined temperature. then proceed with the calibration. or adjustment. a complete calibration is again performed. there will be times when this is not possible. This should be noted in the calibration record.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. but you would not have been able to collect the original “As Found’ readings. it might be metrology department policy to adjust an item if it is more than ½ beyond its in-tolerance range. once the problem is found and repaired. alignment or adjustment and that after a final adjustment was completed to bring the unit back into tolerance. This is why the entire calibration is performed prior to adjustment or alignment. there would not be a problem since it was found to be in tolerance during the first calibration. Compare this to the calibration of pressure gages where a pressure standard is set to a standard pressure. make an adjustment. The standard reading. The UUT is treated the same as any OOT unit. There will be times when an instrument has a catastrophic failure. and the UUT is read to see how much it deviates from the standard. from the working or reference standard you are using to calibrate the UUT. 44 . Then the PMI is completed. However. In this type of situation. alignment. If one were to stop at the point where an OOT is found. there is a good possibility that the adjustment affected other ranges or parts of the calibration. while still meeting its specifications. the standard is set at a predetermined output. Not all UUTs would be considered OOT when “As Left’ readings are taken.
3. or to any artifact that was used as a standard.6 Influence factors and conditions: “All factors and conditions of the calibration area that adversely influence the calibration results shall be defined. recorded. then there should be a place in the calibration form for showing that those conditions were 45 . humidity. In other case. Note: Influencing factors and conditions may include temperature. plus their specifications and range. or at least a statement that a TUR of ≥ 4:1 was met. The same happens when calibrating thermometers.3-2006. electromagnetic interference. As can be seen by the above examples. to NIST. There must be a statement showing traceability to your NMI. and mitigated to meet calibration process requirements.”4 According to ANSI/NCSL Z540. along with the standard. 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. paragraph 5. The UUT is compared to the reference after equilibration. or in the case of most companies in the USA. along with their next calibration due date(s).”5 If the conditions within the area that calibrations are being performed require monitoring according to the standard or requirements that must be met. along with the procedure’s revision number. There should also be a place to identify which calibration procedure was used. They. dust. and a determination is made as to the in or out of tolerance of the UUT. monitored. it is not always possible to set the standard and take a reading from the UUT. Also on the calibration form should be an area to identify the standard(s) that were used. etc. and their pressures recorded on the calibration record.11: “The calibration environment need be controlled only to the extent required by the most environmentally sensitive measurement performed in the area.a basic quality calibration program and the gage(s) under test are then read. and compared to the standard to see if they are in or out of tolerance. Calibration shall be stopped when the adverse effects of the influence factors ad conditions jeopardize the results of the calibration. According to NCSL International Calibration Control Systems for the Biomedical and Pharmaceutical Industry – Recommended Practice RP-6. then a formal program must be in place for tracking those conditions and reviewing the data. If this is the case. You should include any uncertainty budgets if used. vibration. List environment conditions when appropriate and show if they pass or fail. paragraph 5. just as the calibration of autoclaves. are placed in a dry block and a particular temperature is set.
with the following possibilities as an example: • The user/customer was notified and the UUT was adjusted and meets specifications. Do not use white-out. the calibration record must be signed and dated by the technician performing the calibration. Notice that in each circumstance that the user/customer must be notified of any and all OOTs. You should indicate on the form if the calibration passed or failed. or inspected before it is considered a completed record. etc. etc. And finally. OOT conditions. manager. write the correct data. and want to correct the error? For hard copy records. • The user/customer was notified and the UUT was taken out of service and tagged as unusable. the calibration record requires a ‘second set of eyes’. audited. For making corrections to electronic records (eRecords). This means that an individual higher up the chain of command (supervisor. There should be an area set aside in the calibration form for making comments or remarks. or make a duplicate record from scratch with the correct data and explain in the comments block what happened. what was accomplished if an OOT was found. and then place your initials and date next to the data using black ink. Enough space should be available for the calibration technician to include information about the calibration. use whatever tracking system the software uses. were not met. QA inspector. What do you do if. even if internal to the company performing the calibrations. or are not applicable to that calibration. you find that you have made an error. The user/customer. This is called for in all of the standards and regulations. draw a single line through the entry. both hard copy 46 . after recording your results. There should be only one way to file your records. If the UUT had an out-of-tolerance condition. or transposed the wrong numbers. must be informed if their test equipment does not meet their specifications. • The user/customer was notified and the UUT was given a ‘limited calibration’ with their written approval. there should be a place on the form for the final reviewer to sign and date.) must review the calibration record and also sign and date that it has been reviewed. In some instances. then there should be a place to show what happened to the UUT. or erase the original data.a basic quality calibration program either met. and date and sign accordingly. If this is the case.
47 . But the collection of data by electronic means. but also new problems in how to collect. review and store the data. Hard copy records collected during the calibration of test instruments have been discussed in detail already. put it into your written procedures. 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. and eventual storage. 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. It cannot be emphasized enough the criticality of validating your software. There are various ways to do this. Calibration forms should have the range and their tolerances listed for each piece of test equipment being calibrated. process controllers.a basic quality calibration program and eRecords – no matter which system you use. 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. should also be considered. etc. Is the system validated and instrumentation qualified prior to use? If you are using any type of computerized system. accuracies. analysis. data lines and storage systems when going entirely electronic with your calibration records and data management. manage. In some instances it is apparent what the tolerances will be for the items being calibrated. validation of that software is mandatory. or upper/lower limits specified in your procedures or instructions. In other cases it is not quite so apparent.. or through the use of calibration software. and/or compilation into your forms. “Check the results” means make certain the test equipment meets the tolerances. The use of computerized data collection brings with it not only increased productivity and savings in time and effort.
or recall product. 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. 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. According to the FDA: “When accuracy and precision limits are not met. or upper management notification in case of ‘in action’? 48 . and a paper trail for historical reference? After owner/user notification. • Are there any databases that need to be updated. if so is there a time limit.” 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. supervisor or manager? • Is a data base maintained on all OOT test equipment? • Is the customer/user required to reply to the OOT notification.a basic quality calibration program “Act on the difference” means if the test equipment is out of tolerance. you must inform the user because they may have to re-evaluate manufactured goods. change a process or procedure.
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. • Access to OOT data can assist in determining reliability of test equipment. • 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 . • During an audit/inspection (both internal and external) access to past OOT data should be easily available.
The “Say what you do. Those include: a master inventory list. Only about 10% can be easily seen by the casual observer. along with traceability should be apparent to an auditor or inspector. Having an effective calibration management program is usually the difference between being proactive and reactive to performing your routine calibrations. From a managerial standpoint. According to most standards and regulations. environmental conditions (vibration. But the different parts that keep a quality calibration program running efficiently consist of elements from a continuous process improvement program. and the ability to see all items that are currently overdue calibration. Do what you say. By knowing what is coming due calibration. an effective training program. reverse traceability. groups of items by location/part number. and other listings that help to manage your department. correct and properly used calibration and equipment labels. This can be compared to the person who is trying to drain the swamp while fighting off the alligators. items that are OOT. This can be accomplished using the manufacturer’s 50 . scheduling and calibration management software. Check the results. Any calibration management program worth the money should have a few critical areas built into their basic program. bad cables/accessories. the calibration management program should also be able to show calibrations and repairs by individual items. any software program used must be validated prior to implementation. However. before changing calibration intervals. and Act on the difference” portion. the unseen portion is what keeps the iceberg afloat and stable in the ocean. check that the proper specifications are being used.).a basic quality calibration program operator error. the ability to see a 30 day schedule of items coming due calibration. bad standards. and a visible safety program. • If a higher fail rate is noticed. a quality calibration program would be impossible to maintain. poorly written calibration procedures. a comprehensive calibration analysis program. time and other resources to the best advantage. Record what you did. 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. The same can be said of a quality calibration program. standards. etc. you can schedule your technicians. Without any one of these programs. Developing a world-class calibration program A quality calibration program might be compared to an iceberg.
Also. etc. An example would be to start all temperature calibrations (set water baths up for their initial temperature readings). then complete the water baths at their final setting. then perform several pipette or balance calibrations. and keeping the calibration technician involved and focused instead of bored. A best practice among experienced calibration practitioners is the calibration of like items. environment. Most manufacturers recommend a 12 month calibration interval. handling. and the calibration technician is required to gown-up prior to entry every time then go into the clean-room. An example of this would be to calibrate all pressure gages that were shown to be stored or used in a specific area. A particular item used in a controlled environment should be more reliable that one used in a harsher situation. you must consider if the test equipment is used to determine final product where specifications are very tight. Each situation should be considered carefully so that they can be reviewed in the appropriate light. if calibrations were to be performed in a ‘clean room’ environment. increasing productivity. Calibration interval analysis software can be purchased commercially 51 . Another critical yet often times misunderstood program is calibration interval analysis. This would be using your time to the best advantage. return to finish the pipette or balance calibrations.a basic quality calibration program system. or floor of a building. depending on usage. Combining the calibration of like items and mixing and matching items could reduce the task of mundane and boring calibrations. return to set another temperature in the water baths (doing a few at a time). or used as an item that is coded as “No Calibration Required” on a loading dock. say outdoors in severe weather. you are using your time more efficiently. 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. and using your scheduling software to also perform calibrations in geographical areas or combining calibrations in local areas. By not having to stand around to wait for the water baths to equilibrate. Either way. then scheduling all of the calibrations in that area could increase production and reduce down time from multiple entries and exits. Also. or by incorporating an in-house validation system. your validation paperwork needs to be available for inspection during audits and inspections.
This Recommended Practice (RP) is intended to provide a guide for the establishment and adjustment of calibration intervals for equipment subject to periodic calibration. then take the result times 100 for the pass rate • Make a risk assessment of each item for your company’s needs. industries and even countries. Both management and technical information are presented in this RP. Also. Establishment & Adjustment of Calibration Intervals. in time and money. A company could also do their own analysis if they support a limited number of items. divide result by the number of calibrations. adjustment and evaluation programs.a basic quality calibration program and used to evaluate your test equipment. On one side we have the requirement of standards and regulations that govern various companies. Here is an example. The advantages and disadvantages of each method are described and guidelines are given to assist in selecting the best method for a requiring organization. implement and manage calibration interval determination. It provides information needed to design. 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. but one of the foundations for any quality system in the 21st century. Several methods of calibration interval analysis and adjustment are presented. It isn’t a question of do you have a quality calibration program in place. Not only is calibration a requirement. 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. 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. or are on a tight budget and are willing to do their own computations. recalls can be very expensive. but 52 . NCSL International has RP-1. • For each type of equipment.
international. Therefore there can be no quality in the product. document control procedures. money. shape. no matter the size. So is there cost and risk? Absolutely. calibration interval analysis. traceable documentation. Then you can say you have a quality calibration program.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. Without calibration to a traceable standard (national. continuous process improvements. In the case of companies that have untraceable calibration in the production of medical devices. a training program. there can be no repeatability. so the company would never be able to stay in business long enough to impact their market segment. calibration records. traceability or documentation. The cost is huge in terms of lost production. and reputation. pharmaceutical drugs and products that impact human safety – the cost could be immeasurable…with the possibility of death among the results. 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. and the ability to provide quality customer service in a timely manner. or quantity. 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 . But it doesn’t end there. The basic belief is this – it is absolutely essential to have a quality calibration program in place to make a quality product. you must also have all the parts needed to support traceable calibration: calibration procedures. documented training for all your calibration technicians. time. or intrinsic). then it is assumed that to have a quality calibration program. an out-oftolerance program and procedures. 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. This would equate to not having any type of calibration program at all. Referring to a double edged sword. a comprehensive calibration management software package.
Edition 1. 5.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. 2007. Milwaukee: ASQ Quality Press. NCSL International. CO. “If you cannot measure it. EAL-G12. 4. Calibration Control Systems for the Biomedical and Pharmaceutical Industry. CO. 1999. 2. NCSL. Traceability of Measurement. ANSI/NCSL Z540.” 1. December 1999 rev00. 54 . 2006. Expression of the Uncertainty of Measurement in Calibration. EA-4/02. RP-6. Bucher. Jay L. Boulder. 3. malfunctioning. November 1995.3-2006. contaminating or damaging it under normal operating conditions • Using their work order system for requesting service when equipment is broken. The Quality Calibration Handbook. you cannot improve it. Boulder. or in need of calibration As Lord Kelvin was quoted as saying.
confidence levels etc. To be able to answer the question why calibrate.traceable and efficient calibrations Traceable and efficient calibrations in the process industry T oday’s modern process plants. Does this mean that the electricians and instrumentation people should be calibration experts? Not really. Calibration can briefly be described as an activity where theinstrument being tested is compared to a known reference value. with regard to accuracy. repeatability. some understanding of the techniques. 1. i. we must first determine what measurement is and why measuring is necessary. traceable calibration certificate. 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. such as the ISO9000 and ISO14000 series of quality standards. call for systematic and well-documented calibrations. put new and tight requirements on the accuracy of process instruments and on process control. production processes and quality systems. terminology and methods involved in calibration must be known and understood in order to perform according to International Quality Systems. The keywords here are ‘known reference’.e. which means that the calibrator used should have a valid. Quality systems. but this topic should not be ignored.e. However. i. Fortunately. calibrator. 57 . calibrator. modern calibration techniques and calibration systems have made it easier to fulfill the requirements on instrumentation calibration and maintenance in a productive way. uncertainty.
” 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.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 . HIERARCHY OF ACCURACY TRUE VALUE International National standard Authorized Laboratories Instr. it cannot be known. Note: the true value of a quantity is an ideal concept and. in general.” Therefore all instruments display false indications! A set of experimental operations for the purpose of determining the value of a quantity.
optimization is done by means of process automation. in other words. Why calibrate The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability. The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability. in other words. Why measure? The purpose of a process plant is to convert raw material. they drift and lose their ability to give accurate measurements. 3. manpower and capital into products in the best possible way. Anyhow.traceable and efficient calibrations 2. This conversion always involves optimizing. the control cannot be better than the quality of measurements from the process. which must be done better than the competitors. In practice. energy. EVERYTHING IS BASED ON MEASUREMENTS PROCESS CONTROL SYSTEM MEASUREMENTS CONTROLS INSTRUMENTATION MEASUREMENTS ADJUSTMENTS Production Factors PROCESS Products 59 . regardless of how advanced the process automation system is.
systematic calibrations. elapsed time and type of application can all affect the stability of an instrument. Even instruments of the same manufacturer. other quality systems and regulations The ISO9000 and ISO14000 can assist in guiding regular. which produces uniform quality and minimizes the negative impacts on the environment. One unit can be found to have good stability. 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 . while another performs differently. Environment conditions. Environment conditions.traceable and efficient calibrations they drift and lose their ability to give accurate measurements. 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. This drift makes recalibration necessary. elapsed time and type of application can all affect the stability of an instrument. type and range can show varying performance.
traceable and efficient calibrations 4. safeguarded against adjustments that would invalidate the measurement result. Traceability Calibrations must be traceable. When used in the monitoring and measurement of specified requirements. protected from damage and deterioration during handling. This is done prior to initial use and reconfirmed as necessary. Note: See ISO 10012 for further information. Where necessary. measuring equipment is calibrated or verified with measurement standards traceable to national or international standards at specified intervals. identified for the determining of the calibration status. SI-UNITS International standards National standards Reference standards Working standards Process standards 61 . If no such standards exist. the basis used for calibration or verification is recorded. Records of the calibration and verification results are then maintained. maintenance and storage. 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. to ensure valid results. 5. 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. the organization assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. adjusted or re-adjusted as necessary.1 ISO9001: 2008 The organization determines the monitoring and measurements to be performed. In addition. as well as the measuring devices needed to provide evidence of a product’s conformity to determined standards. Traceability is a declaration stating to which national standard a certain instrument has been compared. Regulatory requirements for calibration 5.
Software systems need features such as Electronic Signature.2 PHARMACEUTICAL (FDA. In such a system. • There must be documented evidence that personnel involved in the calibration process have been trained and are competent. • Calibrations must be done in accordance with written. Food and Drug Administration) Any pharmaceutical company that sells their products in the USA must comply with FDA regulations. • Calibration records must be maintained. • All electronic systems must comply with FDA’s 21 CFR Part 11. Users must understand their responsibilities once they give an electronic signature. • Calibration standards should be traceable to national and international standards.traceable and efficient calibrations 5. • 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. and Security System to be able to comply with these regulations. • There should be a record of the history of each instrument. • Documented change management system must be in place. and Security System to be able to comply with these regulations. • A calibration period and error limits should be defined for each instrument. all product. Audit Trails should record all modifications. process and safety instruments should be physically tagged. or delete data from an electronic record. Audit Trail. • All instrumentation should have a unique ID. which add. the Electronic Signature is considered equivalent to a hand-written signature. User Management. U.S. Audit Trail. • Calibration standards must be more accurate than the required accuracy of the equipment being calibrated. regardless of where the products are manufactured. edit. Electronic Signatures” Software systems need features such as Electronic Signature. 62 . • All instruments used must be fit for purpose. approved procedures. User Management. An Audit Trail is required to support change management.
including Annex 11.traceable and efficient calibrations 5. Validation Validation of measurement and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use. regardless of where the products are manufactured. Quite a few of the following terms are also used on specification sheets for calibrators. Resolution Resolution is the smallest interval that can be read between two readings. 63 . 6.2. Please note that the definitions listed here are simplified. DEFINITIONS OF METROLOGICAL TERMS Some metrological terms in association with the concept of calibration are described in this section. Calibration An unknown measured signal is compared to a known reference signal. The requirements for EU GMPs are similar to those of the US FDA. Non-linearity is specified by the Terminal Based method or the Best Fit Straight Line method. as described in Section 5.3 PHARMACEUTICAL (EU GMPs) Any pharmaceutical company that sells their products in the European Union must comply with EU GMPs. Non-linearity Non-linearity is the maximum deviation of a transducer’s output from a defined straight line. Validation of measure ment and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use.
. which can be detected as an output. under normal operating conditions. and then with decreasing values. 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. Drift is usually given as a typical value. The temperature coefficient is usually expressed as % F. / °C or % of RDG/ °C. usually 90 days to 12 months. are included in the accuracy figures provided. or % of RDG + adder. hysteresis. under normal operating conditions. when first approaching this point with increasing values. stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. Good resolution is required in order to detect sensitivity. temperature effects etc. Hysteresis The deviation in output at any point within the instrument’s sensing range.S. 64 Stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. usually 90 days to 12 months. The difference between these two expressions is great. It must also be checked if errors like non-linearity. The only way to compare accuracy presented in different ways is to calculate the total error at certain points.S. Accuracy Generally accuracy figures state the closeness of a measured value to a known reference value.traceable and efficient calibrations Sensitivity Sensitivity is the smallest variation in input. Repeatability is often expressed in the form of standard deviation. Temperature coefficient The change in a calibrator’s accuracy caused by changes in ambient temperature (deviation from reference conditions). The accuracy of the reference value is generally not included in the figures. Stability Often referred to as drift. Accuracy is usually expressed % F.
Type B uncertainty is used when the uncertainty of a single measurement is expressed. It involves the evaluation of uncertainty using scientific judgement based on all available information concerning the possible variables. Type A involves the statistical analysis of a series of measurements.traceable and efficient calibrations Uncertainty Uncertainty is an estimate of the limits. The standard deviation. at a given cover factor (or confidence level). Standard deviation is used as a measure of the dispersion of values. in an unpredictable manner. often called the “root-mean-square repeatability error”. set-up of the measuring.e. could be said to be of a systematic nature. i. Type B uncertainty Type B evaluation of uncertainty involves the use of other means to calculate uncertainty. in general. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. ambient conditions. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. there will be an observable difference in the values measured. The other group of components. for a series of measurements under the same conditions. errors in calculation. Examples of such errors include: errors in recording data. Examples of systematic effects include errors in reference value. which can vary in magnitude and in sign. the effects of these components include measurement errors. If there is sufficient resolution in the measurement. Uncertainty is evaluated according to either a “Type A” or a “Type B” method. Values belonging to this category may be derived from: It should be noted that. It should be noted that. etc. is used for calculation. or the use of inappropriate technology. Type A uncertainty The type A method of calculation can be applied when several independent measurements have been made under the same conditions. in general. 65 . Systematic errors or effects remain constant during the measurement. Type B. which contain the true value. uncertainty is calculated using Type A uncertainties. rather than applying statistical analysis of a series of measurements. In this case.
7. especially in a measurement situation where a Type A evaluation is based only on a comparatively small number of statistically independent measurements. For uncertainty specifications.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. should be used. The maintenance management system may alert when calibration is 66 . 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. there must be a clear statement of cover probability or confidence level. in ISO9001: 2008. CALIBRATION MANAGEMENT Many companies do not pay enough attention to calibration management although it is a requirement e.g. there must be a clear statement of cover probability or confidence level. It is a skill that can be learnt with practice. k=2. the standard coverage factor. The expanded uncertainty corresponds to a coverage probability (or confidence level) of approximately 95%. Usually one of the following confidence levels are used: 1 s = 68% 2 s = 95% 3 s = 99% For uncertainty specifications. In cases where normal (Gaussian) distribution can be assumed. A well-based Type B evaluation of uncertainty can be as reliable as a Type A evaluation of uncertainty.
etc. the software automatically detects the calibrator that was used. and there is no need to write down anything with pen. The increase in work productivity allows for more calibrations to be carried out within the same period of time as before. Unfortunately. If something is documented. Once the job has been done. it is usually in the form of a hand-written sheet that is then archived. Thus the calibrator is able to detect if the calibration was passed or failed immediately after the last calibration point was recorded. An efficient calibration management system consists of calibration management software and documenting calibrators. It automatically creates a list of instruments waiting to be calibrated in the near future. There is no need to make tricky calculations manually in the field. Choosing professional tools for maintaining calibration records and doing the calibrations can save a lot of time. and the traceability chain is documented without requiring any further actions from the user. no printed notes. finding the sheets requires a lot of effort. are needed. using automated tools can be 5 to 10 times faster compared to manual recording. While the calibration results are uploaded onto the database. 67 . Modern calibration management software can be a tool that automates and simplifies calibration work at all levels. 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. When the technician is about to calibrate an instrument. Depending on what process variable is calibrated and how many calibration points are recorded. Calibration records. the work order will close and the maintenance system will be satisfied. 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. All this saves an extensive amount of time and prevents the user from making mistakes. effort and money.traceable and efficient calibrations needed and then opens up a work order. (s)he simply downloads the instrument details from the calibration management software into the memory of a documenting calibrator. The “As Found” and “As Left” are saved in the calibrator’s memory. If the calibration results need to be examined at a later time. what happens between opening and closing of the work order is not documented very often. The instrument’s measurement ranges and error limits are defined in the software and also downloaded to the calibrator.
Foundation Fieldbus or Profibus output of the transmitters. 68 . If a calibrator drifts out of its specifications. are kept in the database. If the system manufacturer has paid attention usability. In addition to the conventional mA output of a transmitter. the users can concentrate on their primary job. the system is easy to learn and use. Although there is a lot of data involved. When many tasks are automated. If the calibration management software includes the right tools. If paper copies of certificates are preferred. It is not very uncommon to have a calibrator that calibrates pressure. instrument. it does not mean the job is an enormous one. 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. therefore accessing previous results is also possible in just a few seconds. which assists in determining whether or not the calibration period should be changed. 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. of course. When an auditor comes for a visit. software displays the “History Trend”. and they can be even used for configuring these “smart” transmitters. The requested calibration records can be viewed on screen with a couple mouse clicks. QA will find a calibration management system useful. For instance the maintenance manager can use it as a calibration planning and decision-making tool for tracking and managing all calibration related activities. When an instrument has been calibrated several times. Today’s documenting calibrators are capable of calibrating many process signals.traceable and efficient calibrations Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. When all calibration related data is located in a single database the software is obviously able to create calibration related reports and documents. Transferring to a new calibration system may sound like a huge task and it can be a huge task. printing them must. Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. modern calibrators can also read HART. temperature and electrical signals including frequency and pulses. One of today’s trends is to move towards to a paperless office. Good calibration tools help technicians work more efficiently and accurately. be possible.
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. etc. 69 . Maintenance databases. CONCLUSION A good. automated calibration system reduces workload because it carries out tasks faster. References  ISO9001: 2008 “Quality Management Systems. automated calibration system reduces workload. Requirements”  21 CFR Part 11: “Electronic Records. Electronic Signatures”  21 CFR Part 211: “Current Good Manufacturing Practice for Finished Pharmaceuticals” A good. scheduling. It assists in documenting. analyzing and finally optimizing the calibration work. more accurately and with better results than what could be reached with a manual system.traceable and efficient calibrations Nowadays most companies have instrumentation data in some type of electronic format: as Excel spreadsheets. planning.
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.
an end product manufactured by a plant with poorly calibrated instruments could present a risk to both consumers and customers. energy. harsh 74 Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. oil and gas. There is therefore a growing need to have the metrological quality of these weighing instruments confirmed by calibration. who invoice customers based on the mass of what they supply (fiscal metering). neglecting calibration can lead to unscheduled production or machine downtime. aviation companies. These companies need to prove not only that the mass is accurate but also that the equipment producing the readings was correctly calibrated. Invoicing in these industries is often based on process measurements. Why is calibration important? Calibration ensures that instrument drift is minimized. product and process quality issues or even product recalls and rework. Furthermore. It is therefore critical that all instruments are calibrated at appropriate intervals. . calibration has costs associated with it and in uncertain economic times. Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. Determining the correct mass of a product or material is particularly important for companies that supply steel. Similarly. In certain situations. The stability of an instrument very much depends on its application and the environment it operates in. power.why calibrate The costs and risks of not calibrating Unfortunately. also need to calibrate their weighing instruments. Fluctuating temperatures. allowing that sensor to drift over time could potentially result in a risk to employee safety. Weighing instruments also need to be calibrated regularly. chemical and pharmaceutical industries. Product manufacturing also depends on accurate masses and so laboratories and production departments in the food and beverage. However. This is particularly true for the food and beverage sector and for pharmaceutical manufacturers. this may even lead to a company losing its license to operate due to company not meeting its regulatory requirements. if the instrument is critical to a process or is located in a hazardous area. harbors and retail outlets. paper and pulp. 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.
The role of calibration is very important to ensure the quality and safety of the processes. a calibration interval and error limits should be defined for each instrument and standards should be traceable to national and international standards. All product. Furthermore. The company must also have a documented change management system in place. Calibration also ensures that product or batch quality remains high and consistent over time. We must therefore ensure that all processes correspond to the planned characteristics.6%. repeatability. instrument calibration can help to optimize a company’s production process or to increase the plant’s production capacity. uncertainty and confidence levels. All the plants in Spain have received ISO 9001 and ISO 14001 certifications. Standards must also be more accurate than the required accuracy of the equipment being calibrated. 75 . each instrument has a master history record and a unique ID. with all electronic systems complying with FDA regulations 21 CFR Part 11. For example. Quality systems such as ISO 9001. requires that calibration records are maintained and calibrations have to be carried out in accordance with written. This affects all process manufacturers. energy and utilities industries. Even instruments manufactured by the same supplier can vary in their performance over time. well-documented calibrations with respect to accuracy. The role of calibration is very important to ensure the quality and safety of the processes.4%.” Pharmaceutical manufacturers must follow current Good Manufacturing Practices. approved procedures. In the power generation. process and safety instruments should also be physically tagged. enabled the reactor power in each unit to be increased by 1. 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. Incorrect measurements in a hazardous area could lead to serious consequences. Typically. the quality of the beer is a number one priority. which has a significant effect on annual production capacity. in addition to the BRC certificate of food safety. Armando Rivero Rubalcaba is head of Instrumentation at beer producer Heineken (Spain). at the Almaraz Nuclear Power Plant in Spain.why calibrate manufacturing conditions (dust and dirt) and elapsed time are all contributing factors here. On the people side. GMP. ISO 9002 and ISO 14001 require systematic. Safety is another important reason to calibrate instruments. by improving the measurement of reactor power parameters from 2% to 0. He comments: “For Heineken.
especially from the viewpoint of production safety and quality of the final product. Indeed. Therefore. according to recent research by Nielsen Research/ ATS Studies. Heikki Karhe is a measurement technician at the tyre manufacturer Nokian Tyres. Proper invoicing is therefore critical to energy and utilities companies. this figure rises dramatically to more than 4 million US dollars per year. Measuring instruments that yield wrong values could easily ruin the final product. Customers want to pay for the exact amount of gas they’ve received. Preparation of the right rubber mixture is precision work and a sample is taken from each rubber mixture to ensure quality. As Jacek Midera.” Neglecting to calibrate process instruments can also affect a company’s bottom line profits. This is particularly true if sales invoicing is based on accurate process measurements. Calibrating instruments can help to make combustion more efficient in industrial ovens and furnaces. accurate measurements ensure proper billing. The latest Government regulations relating to carbon emissions may also require that companies calibrate specific instruments on a regular basis.why calibrate Calibration is of great importance. gas conversion devices must be extremely accurate in measuring delivered gas. poor quality calibration is on average costing manufacturers more than 1. As Ed de Jong. weighing scales or gas conversion devices. controlling emissions is another critical factor for many process manufacturers. manufacturers of food and beverage or pharmaceutical products could put their customers’ lives at risk by neglecting to calibrate their process instruments. As he puts it: “Calibration is of great importance.7 million US dollars every year. The impact of even a small measurement error can be tremendous in terms of lost revenue. particularly in the oil and gas. When only large companies with revenues of more than 1 billion US dollars are considered. especially from the viewpoint of production safety and quality of the final product. petrochemicals and chemicals sectors. 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 .” Today. 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. including sensors used for measuring CO2 and NOX emissions. Instrument Maintenance Engineer at Shell (Netherlands) explains: “Until recently. Similarly. for example. measurement specialist at Mazovian Gas Company states: “Most importantly. This means that requirements for the calibrators are especially high.
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. The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. highly stable sensors are not calibrated as often as those sensors that are more susceptible to drift. calibration has an important role especially for the license to operate. Changing the output signal does not change the need for periodic calibration.” Common misconceptions There are some common misconceptions when it comes to instrument calibration. some manufacturers claim that they do not need to calibrate their fieldbus instruments because they are digital and so are always accurate and correct. First. How often they are calibrated depends on a number of factors. as well as begin to monitor the stability or drift of the instrument over time. Although fieldbus transmitters have been improved in terms of their measurement accuracy when compared to analogue transmitters. By calibrating an instrument before installation. Quality standards may also dictate how often a pressure or temperature sensor needs calibrating. Again. for example. The optimal calibration interval for different instruments can only be determined with software-based history trend analysis. Government regulations demand that specific instruments must be calibrated. 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. the manufacturer of the instrument will provide a recommended calibration interval. Nowadays. In this way. This is simply not true.why calibrate involved for both customers and governments [fiscal metering]. 77 . instruments related to CO2 and NOX emissions. The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. this is not true. For example. this does not eliminate the need for calibration. When to calibrate Due to drift. The main difference between fieldbus and conventional transmitters is that the output signal is a fully digital fieldbus signal. Just because a sensor is newly installed does not mean that it will perform within the required specifications.
Finally. quality. Careful planning and decision-making is important. These methods differ greatly in terms of cost.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. followed by the selection of suitable calibration methods and tools for execution of these methods. 79 . efficiency. execution. pressure transducers and weighing instruments – require regular calibration to ensure they are performing and measuring to specified tolerances. different companies from a diverse range of industry sectors use very different methods of managing these calibrations. However. Once this has been agreed. the company must identify current calibration status for every instrument across the plant. There are five main areas here. Decisions then need to be made regarding the calibration interval for each instrument. But in order to understand how software can help process plants better manage their instrument calibrations. All plant instruments and measurement devices need to be listed. then classified into ‘critical’ and ‘non-critical’ devices. it is important to consider the typical calibration management tasks that companies have to undertake. with documentation being a critical part of this. and accuracy of data and their level of automation. comprising of planning and decision-making. Plant instrumentation devices such as temperature sensors. the calibration range and required tolerances need to be identified. Calibration software is one such tool that can be used to support and guide calibration management activities. Calibration software is one such tool that can be used to support and guide calibration management activities. documentation. and analysis. with documentation being a critical part of this. The creation and approval of standard operating procedures (SOPs) for each device is then required. organisation.
If. calibration labels need to be created and pasted. These intervals may need to be adjusted based on archived calibration history. including any associated safety procedures. then classified into ‘critical’ and ‘non-critical’ devices. The calibration is then executed according to the plan. companies then have to analyse the data to see if any corrective action needs to be taken. approved procedures. ISO 9001:2008 and the FDA both state that calibration records must be maintained and that calibration must be carried out according to written. for example. Based on the calibration results. 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. Resources then have to be organised and assigned to actually carry out the scheduled calibration tasks. the consequences could be disastrous for the plant. Staff carrying out these activities must follow the appropriate instructions before calibrating the device. 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. which may then have to be scrapped. involves training the company’s calibration staff – typically maintenance technicians. Documentation Documentation is a very important part of a calibration management process. process and quality engineers and managers – in using the chosen tools and how to follow the approved SOPs. and documenting and archiving calibration data. although further instructions may need to be followed after calibration. then created documents copied and archived.why use software for calibration management All plant instruments and measurement devices need to be listed. The next stage. a safety problem or leading to batches of inferior quality goods being produced. This paperwork typically involves preparing calibration instructions to help field engineers. The effectiveness of calibration needs to be reviewed and calibration intervals checked. resulting in costly production downtime. a sensor drifts out of its specification range. service engineers. organisation. The execution stage involves supervising the assigned calibration tasks. The next calibration tasks then have to be scheduled. 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 .
In the highly regulated pharmaceuticals sector. In the Power & Energy sector.000 calibrations per year. just under a third of companies (with 500+ employees) typically have more than 5. analysis of paper-based systems and spreadsheets can be almost impossible. 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. 40 per cent of companies surveyed said that they calculated calibration intervals by using historical trend analysis – which is encouraging. Oil. 81 . 42 per cent of companies perform more than 2. let alone time consuming. However. Only a quarter of companies use calibration software In Beamex’s own Calibration Study carried out recently. Furthermore. but many firms still do this. In a recent survey conducted by Control Magazine. different industry sectors have different requirements and regulations.why use software for calibration management When it comes to the volume of documentation required.000 times every year. many of these firms said they were doing it without any sort of calibration software to assist them. Noting down calibration results by hand in the field and then transferring these results into a spreadsheet back at the office may seem archaic. for example. This equates to a huge amount of paperwork for any process plant. whilst others used a calibration module within an existing Computerised Maintenance Management System (CMMS). A significant proportion (almost 20 per cent) of those surveyed said they used a manual. Many other companies said that they relied on generic spreadsheets and/or databases for this. 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. a massive 75 per cent of companies carry out more than 2. with 55 per cent of companies performing 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. Any type of paper-based calibration system will be prone to human error. paper-based system. where 21 per cent of firms said they calibrated their instruments more than 2.000 calibrations each year. However. The percentage is still quite high in the food & beverage sector. Gas & Petrochemicals is similarly high.000 calibrations each year. the picture in reality can be very different.000 instruments that require calibrating.
the company may be able to decrease the frequency of calibration. Just as important. The number of instruments and the total number of periodic calibrations that these devices require can be several thousand per year. this might include engineers using pens and paper to record calibration results while out in the field. a process plant may find it necessary to increase the frequency of some sensors that are located in a hazardous. On returning to the office. the plant may be able to extend these intervals by looking closely at historical trends provided by calibration management software. For example. Regardless of industry sector. 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. easier and more accurate analysis of calibration records and identifying historical trends. easier and more accurate analysis of calibration records and identifying historical trends. instrument calibration intervals based on either the manufacturer’s own recommendation. there seems to be some general challenges that companies face when it comes to calibration management. Rather than rely on the manufacturer’s recommendation for calibration intervals. paper-based system requires little or no 82 . Furthermore. Neither method is ideal in practice. Plants can therefore reduce costs and optimise calibration intervals by reducing calibration frequency when this is possible. saving time and resources. Companies could save so much time and reduce costs by using calibration management software to analyse historical trends and calibration results. after which they are archived as paper documents. for improved safety. While using a manual. every instrument calibration has to be documented and these documents need to be easily accessible for audit purposes. or by increasing the frequency where necessary. these notes are then tidied up or transferred to another paper document. or they used a uniform interval across the plant for all instruments. potentially explosive area of the manufacturing plant. by analysing the calibration history of a flow meter that is located in a ‘non-critical’ area of the plant. Paper-based systems These systems typically involve hand-written documents.why use software for calibration management Using software for calibration management enables faster. Using software for calibration management enables faster. Typically.
and Regardless of industry sector. 83 . Plant hierarchy and works orders can be stored in the CMM system. The software manages and stores all instrument and calibration data. This includes the planning and scheduling of calibration work. it is very labour-intensive and means that historical trend analysis becomes very difficult to carry out. Although instrument data can be stored and managed efficiently in the plant’s database. etc. In-house legacy systems (spreadsheets. the level of automation is still low. FDA) for managing calibration records.why use software for calibration management investment. calibration data is typically entered manually into a spreadsheet or database. soaks up a lot of resources and typing errors are commonplace. Furthermore. Dual effort and re-keying of calibration data are also significant costs here.) Although certainly a step in the right direction. 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. CMM systems are not designed to manage calibrations and so often only provide the minimum calibration functionality. The data is stored in electronic format. In these systems. the CMM system may not meet the regulatory requirements (e. there seems to be some general challenges that companies face when it comes to calibration management. automatic alarms cannot be set up on instruments that are due for calibration. databases. Also. but the recording of calibration information is still time-consuming and typing errors are common. but the calibration cannot be automated because the system is not able to communicate with ‘smart’ calibrators. analysis and optimisation of calibration frequency. In addition. The system is time consuming. certificates and labels. the calibration data is not easily accessible. users are provided with an easy-to-use Windows Explorer-like interface. For example. Calibration software With specialist calibration management software. such as the scheduling of tasks and entry of calibration results. using an in-house legacy system to manage calibrations has its drawbacks.g. the calibration process itself cannot be automated. production of reports. communication with smart calibrators. In addition.
Locating records and verifying that the system works is effortless when compared to traditional calibration record keeping. such as Change Management. Regulatory organisations and standards such as FDA and ISO place demanding requirements on the recording of calibration data.why use software for calibration management easy integration with CMM systems such as SAP and Maximo. Calibration certificates. which improves quality. reports and labels can all be printed out on paper or sent in electronic format. The software generates reports automatically and all calibration data is stored in one database rather than multiple disparate systems. The result is a streamlined. Using software for calibration management enables faster. then automatically uploaded back to the calibration software. Using software-based calibration management systems in conjunction with documenting calibrators means that calibration results can be stored in the calibrator’s memory. The system no longer requires pens and paper. Organisation also improves. There is no re-keying of calibration results from a notebook to a database or spreadsheet. Documentation is also improved. 84 . automated calibration process. easier and more accurate analysis of calibration records and identifying historical trends. Calibration software has many functions that help in meeting these requirements. complies with FDA requirements. Also. Position. Audit Trail and Electronic Signature functions. planning and decisionmaking are improved. plant productivity and efficiency. Procedures and calibration strategies can be planned and all calibration assets managed by the software. The Change Management feature in Beamex’s CMX software. Human error is minimised and engineers are freed up to perform more strategic analysis or other important activities. for example. calibration software can facilitate both the preparation and the audit itself. while automatic alerts for scheduled calibrations can be set up. device and calibrator databases are maintained. Execution is more efficient and errors are eliminated. Benefits of using calibration software With software-based calibration management. These instructions can also be downloaded to a technician’s handheld documenting calibrator while they are in the field. Calibration instructions are created using the software to guide engineers through the calibration process. Analysis becomes easier too. enabling engineers to optimise calibration intervals using the software’s History Trend function. when a plant is being audited.
Manual procedures are replaced with automated. CMX Enterprise. Beamex’s high-end solution. as the entire calibration process is now streamlined and automated. Here. calibration management software can be easily integrated to this system. reduce costs and increase productivity by preventing unnecessary double effort and re-keying of works orders in multiple systems. Plant efficiencies should also improve. those instruments that perform better than expected may well justify a reduction in their calibration frequency. Costly production downtime will also be reduced. implementation. the calibration management software can utilise the records available in the CMM system database. 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 . a central calibration management database is often implemented that is used by multiple plants across the world. which simply is not possible with a standalone CMM system. Integration also enables the plant to automate its calibration management with smart calibrators. 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. with no manual documentation procedures. For relatively small plants. Beamex CMX Professional is ideal. where calibration data is needed for only one location.Business benefits For the business. validated processes. is suitable for process manufacturers with multiple global sites. For medium-to-large sized companies that have multiple users who have to deal with a large amount of instruments and calibration work. multilingual users and a very large amount of instruments that require calibration. If the plant instruments are already defined on a database. only a few instruments require calibrating and where regulatory compliance is minimal. The integration will save time. implementing software-based calibration management means overall costs will be reduced. as well as strict regulatory compliance. which is particularly beneficial if the company is replacing a lot of labour-intensive calibration activities. Beamex CMX Light is the most appropriate software. For example. Even if a plant has already implemented a CMM system. Engineers can analyse calibration results to see whether the calibration intervals on plant instruments can be altered. These savings come from the now-paperless calibration process. Benefits for all process plants Beamex’s suite of calibration management software can benefit all sizes of process plant.
across all industry sectors. whilst 92% said that using CMX had improved the quality of their calibration system. regardless of industry sector. Compared to traditional. Summary Every type of process plant.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. only one quarter of companies who need to manage instrument calibrations actually use software designed for that purpose. increased productivity and reduced costs of the entire calibration process. can benefit from implementing specialist calibration management software. in-house built legacy calibration systems or calibration modules with CMM systems. The business benefits of using software for calibration management • Cost reduction • Quality improvements • Increase in efficiency 86 . paper-based 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. Despite these benefits. 94% of CMX users stated that using Beamex products had improved the efficiency of their calibration processes. using dedicated calibration management software results in improved quality.
89 . However. being calibrated less frequently or not at all.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. Plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’. the time and resources required to carry out these calibration checks are often scarce. By doing it. the consequences can be disastrous for a plant. flow meters and the like – are performing and measuring to specified tolerances. Calibration history trend analysis is only possible with calibration software that provides this functionality. a function available within Beamex® CMX calibration software. but for other sensors that are deemed less critical to production. resulting in costly production downtime. pressure transducers. which then have to be scrapped. which ensures that all instruments used across the site are calibrated at the appropriate times. Adjusting calibration intervals based on history trend analysis Manufacturing plants need to be absolutely confident that their instrumentation products – temperature sensors. Most process manufacturing plants will have some sort of maintenance plan or schedule in place. with those deemed critical enough receiving the required regular checks. a plant is able to define which instruments can be calibrated less frequently and which should be calibrated more frequently. safety issues or possibly leading to batches of inferior quality goods being produced. If sensors drift out of their specification range. with increasing demands and cost issues being placed on manufacturers these days. This can sometimes lead to instruments being prioritised for calibration.
a function available within Beamex® CMX calibration software. In addition. the plant can analyze whether it should increase or decrease the calibration frequency for all its instruments. oil and gas. ensuring that instruments are checked and corrected before they drift out of tolerance.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. But plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’. power and energy. paper and pulp. This type of practise is common in companies that employ an effective ‘Preventive Maintenance’ regime. With this function. due to it being a highly regulated industry. Perhaps unsurprisingly. in the pharmaceuticals sector. Current practices in process plants But in reality. The survey covered all industry sectors. chemicals. 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. service. However. is only possible with calibration software that provides this type of functionality. manufacturing. for example. Cost savings can be achieved in several ways. food and beverage. including pharmaceuticals. by calibrating instruments more often when they are located in critical areas of the plant. The analyses of historical trends and how a pressure sensor. these plants also calibrate their instruments more frequently than other industry sectors. 90 . Interestingly. Second. 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. 59% said they calibrated once a year and 30% said they calibrated twice a year. the study proved also that the pharmaceuticals sector typically possesses a significantly higher number of instruments per plant that require calibrating. drifts in and out of tolerance over a given time period. the survey showed that from all industry sectors. First. by calibrating less frequently where instruments appear to be highly stable according to their calibration history. 56% of the respondents said they calibrated their instruments no more than once a year.
Sensors that are found to be highly stable do not need to be re-calibrated as often as sensors that tend to drift.” The trick. 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. says Mäki. can use the functionality to compare different sensor types to see which one best suits the new process. As Mäki explains: “When an engineer buys a particular sensor. the engineer now has data to present to the supplier to support his findings. 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. He specialises in selling the Beamex® CMX to different customers across all industry sectors. therefore eliminating unnecessary calibration effort and time. the historical trend) companies can reduce costs and improve their efficiencies. or even years of operation and which can be left for longer periods. Pertti Mäki is Area Sales Manager at Beamex. 91 . without doubt. If it hasn’t. But there are other. Calibration software such as CMX can also help with the planning of calibration operations. is determining which sensors should be recalibrated after a few days. 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. weeks. without of course sacrificing the quality of the product or process or the safety of the plant and its employees. enables maintenance staff to concentrate their efforts only where they are needed. the supplier provides a technical specification that includes details on what the maximum drift of that sensor should be over a given time period. With CMX’s History Trend Option.” But that’s not all. Doing this. he says.how often should instruments be calibrated The benefits of analyzing calibration history trends But regardless of the industry sector. by analysing an instrument’s drift over time (ie. actually performed within the specified tolerance over a certain time period. The function enables users to plan the optimal calibration intervals for their instruments. the engineer can now verify that the sensor he or she has purchased. but all industry sectors can benefit from using the software tool. which helps companies identify the optimal calibration intervals for instruments. He comments: “The largest savings from using the History Trend Option are in the pharmaceuticals sector. in setting up a new process line for example.
Also. the user can get an overview of how a particular device drifts between calibrations and also whether the drift increases with time. 92 . using the ‘Report Design’ tool option. for example. maintenance personnel. The ‘History Trend’ window enables users to view key figures of several calibration events simultaneously. Based on this information. allowing to evaluate the calibrations of a position or a device for a longer time period compared to the normal calibration result view. Once implemented. History Trend displays the instrument’s drift over a given period both numerically and graphically.how often should instruments be calibrated History Trend displays the instrument’s drift over a given period both numerically and graphically. the engineer can analyze how different devices are suited for use in a particular area of the plant or process. Reporting is straightforward and the user can even tailor the reports to suit his or her individual needs. 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 function enables users to plan the optimal calibration intervals for their instruments. can analyze an instrument’s drift over a certain time period.
• The Beamex® CMX stores every calibration event into the database. 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. 93 . This helps in comparing differences between devices.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 graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments. the history trend is made automatically without any extra manual work. • 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 ability of computer software to satisfy the intended application shall be confirmed. Records of the results of calibration and verification shall be maintained (see 4. against measurement standards traceable to international or national measurement standards. e) be protected from damage and deterioration during handling. When used in the monitoring and measurement of specified requirements. Where necessary to ensure valid results. or prior to use.2. measuring equipment shall a) be calibrated or verified at specified intervals. d) be safeguarded from adjustments that would invalidate the measurement result.how often should instruments be calibrated ISO 9001:2008 quality management requirements 7. 95 . the basis used for calibration or verification shall be recorded. c) be identified to enable the calibration status to be determined. the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. 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. maintenance and storage. b) be adjusted or re-adjusted as necessary.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. In addition.4). The organization shall take appropriate action on the equipment and any product affected. This shall be undertaken prior to initial use and reconfirmed as necessary. where no such standards exist.
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.
a maintenance or service Far too many of these companies still use paper-based calibration systems. As manufacturing companies. calibrating instruments is an enormous task that consumes vast amounts of paperwork. perhaps even a poster on the wall. which means they are missing out on the benefits of moving towards a paperless calibration system. weighing instruments and pressure transducers. Whilst out in the field. amongst the process manufacturing industries. Take a minute to look around the room you are in and you’ll notice how many objects are made from paper: books. Other than helping to save our planet and reducing the number of trees cut down each year. our consumption of paper is far higher than it needs to be. a paper-based calibration system involves the use of handwritten documents. Far too many of these companies still use paper-based calibration systems. especially given that there are technologies. Today.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. which means they are missing out on the benefits of moving towards a paperless calibration system. ecology. significant benefits in minimising the use of paper. 101 . Take the calibration of plant instrumentation devices such as temperature sensors. Globally.com). there are other. So let’s not add to this already heavy burden on our forests and the environment. as businesses. magazines. 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. software and electronic devices readily available today which render the use of paper in the workplace unnecessary. Global consumption of paper has grown 400% in the last 40 years. Traditional paper-based calibration systems Typically. printer paper.
these notes are then tidied up and/or transferred to another paper document. paper-based system requires little or no investment in new technology or IT systems. accessing calibration data quickly is not easy. On returning to the office. Often. as those individuals who need to sign off records or calibration 102 . etc. In addition. Dual effort and the re-keying of calibration data into multiple databases become significant costs to the business. after which they are archived as paper documents. engineer will typically use a pen and paper to record instrument calibration results. After all. it is extremely labourintensive and means that historical trend analysis of calibration results becomes very difficult. important paper records could potentially be lost or damaged in an accident or fire. workflow and making other significant cost savings for the business. when these records can all be combined into a single electronic record? Improved workflow With paper-based systems. it is not practicable to store or carry lots of paperwork. So why would these companies generate and store separate paper copies of important records such as works orders. There will be less waiting time. every square foot of the business has an associated cost. by utilising the latest software-based calibration management systems from companies like Beamex. standard operating procedures (SOPs). these organisations can significantly reduce their paper consumption. However. workflow improves dramatically. These same companies that use paper-based calibration systems are together generating hundreds of thousands (millions?) of paper calibration certificates each year. paper records that need approval have to be routed to several individuals. they soak up lots of company resources and manual (typing) errors are commonplace. Practical benefits of using less paper Aside from the financial benefits of moving towards a paperless calibration system. there are practical reasons why firms should go paperless. While using a manual. With paperless systems. Furthermore. in industrial environments. blank calibration certificates. which is time-consuming. Paper systems are time consuming.paperless calibration improves quality and cuts costs With paperless systems. whilst also improving quality. workflow improves dramatically.
Business benefits For those more enlightened companies that use software-based calibration systems. manual errors such as misreadings can occur. Illegible handwritten notes are also a problem. electronic records enable easier analysis of data. the business benefits are significant. Just as important. which again has cost reduction benefits to the business. particularly when using weighscales or other instruments that are open to an individual’s own interpretation of the data. For example. Costly production downtime due to unforeseen instrument failures will also be reduced. Sometimes users may inappropriately modify the results data due to work pressures or lack of time/resources. this means that operators. Calibration intervals can be optimised. particularly calibration results. Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. especially if these paper records need to be typed or transcribed to a computer system or database. whilst mistakes and manual errors will be virtually eliminated. The cost and time associated with printing copies of paper documents is also eliminated. those instruments that are performing better than expected may well justify a reduction in their calibration frequency. engineers and management will have more confidence in Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. calibration software facilitates both the preparation and the audit itself. Historical trending becomes easier. 103 . faster and more reliable. When a plant is being audited. Locating records and verifying that the system works becomes effortless when compared to traditional paper-based record keeping.paperless calibration improves quality and cuts costs documents can share or access electronic records simultaneously from a central database. In turn. Data integrity The integrity of paper-based calibration systems cannot be relied upon. 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. The whole calibration process – from initial recording of calibration data through to historical trend analysis – will take less time. Paper records may not always reflect the truth. For example. as well as the cost of filing and storing those paper records.
resulting in completely paperless. electronic records are easy to manipulate and can be re-used in different IT systems. Electronic data also provides an excellent foundation for ongoing plant operation and maintenance. end-to-end workflows. In addition. A key part of paperless calibration records is the capture of data at point of work. business management systems. without needing to collect all the plant data again. often in difficult industrial environments that would make the use of portable office computers impractical. The un-editable electronic data stored on high performance multifunction calibrators can be uploaded to calibration management software for safe storage and asset management.paperless calibration improves quality and cuts costs the data. technician friendly interfaces on industrialized PDA or tablet based hardware when manual data entry cannot be avoided. 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. In other words. The calibration data is shared with other business IT systems electronically. the calibration data is shared with other business IT systems electronically. data historians. 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. How paperless should you go? Of course. 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. particularly when it comes to plant audits. Commissioning At plant commissioning times. resulting in completely paperless. many companies are neither completely paperless nor rely solely on paper-based systems – the process is sometimes a hybrid of the two. increased efficiencies and reduced plant downtime. Companies can go even further than this and use electronic records for works orders. in reality. and for control systems. electronic records simplify the handover of plant and equipment. Although handover by commissioning teams that use paper records is straightforward and of universal format. end-to-end workflows. 104 .
Croda uses the CMX calibration management software system from Beamex. Amongst these customers is UK firm Croda Chemicals Europe. paper-based systems. Oil Gas & Petrochemicals companies. education and training services for customers. which may be used to dealing with traditional. This includes a functionality check on all of the pressure instrumentation.” Education and training for users is critical. 105 . paper-based systems. as this will help companies to overcome the natural resistance to change amongst the workforce. Power & Energy. 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. Based in East Yorkshire near Goole. as well as the sensors that monitor the incoming chemical additives and the outgoing effluent. the Croda plant uses pressurised vessels to purify lanolin for healthcare and beauty products. Beamex provides comprehensive validation.” says Wright. “It’s faster. Chemicals. “It’s saving us around 80 manhours per maintenance period and should pay for itself in less than three years. training & education Paperless systems also need validating in the user’s own environment. which coordinates data collection tasks and archives the results.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. which may be used to dealing with traditional. including Pharmaceuticals. Case study Beamex is helping many organisations to implement paperless calibration management systems. 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.” Today. Validation. as this will help companies to overcome the natural resistance to change amongst the workforce. it is better to source the data electronically using documenting calibrators that are specifically designed for this task. easier and more accurate than our old paper-based procedures. Education and training for users is critical.
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. What is process instrument commissioning? Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. Successful commissioning of process instrumentation is an essential requirement for ideal plant performance. Energizing power systems. or any defined part of a plant. In general. These activities are usually described as ‘cold commissioning’. This article explains process instrument commissioning and the benefits of calibration during the commissioning phase. is ready for commissioning when the plant has achieved mechanical completion. calibration of instrumentation. A plant.intelligent commissioning Intelligent commissioning C alibration plays a vital role in process plant commissioning and when installing new instruments. 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. the plant will be fully ready for production operation. At the completion of commissioning. operational testing of plant equipment. testing of the control systems as well as verification of the operation of all interlocks and other safety systems are also typical commissioning tasks. Commissioning may involve mock operations which are commissioning activities conducted to allow operational testing of the equipment and operator training and familiarization. Pre-commissioning activities are those which have to be undertaken 107 .
As there are many cost factors in the commissioning process. these steps must be repeated with every field device that will be installed at the plant. configuring the required parameters and testing the configuration and interface to other systems. Basically. and a schedule needs to be established for each task including benchmarks for monitoring purposes. detailed planning of commissioning and plant handover are essential elements of the overall project plan and schedule as any other grouping of activities. 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. The rate 108 . personnel and cost of commissioning Since commissioning takes place toward the end of the project. 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. and the re-commissioning activities have been completed to the extent where the owner approves the plant and can begin commissioning activities. as the plant owner’s commitments in terms of product marketing and operational costs are likely to be higher. Each of the commissioning activities must be broken down into a number of manageable tasks. because the funds have been allotted to cover budget overruns. connecting to and identifying the field device. there is a risk that the work may be under-resourced. It is essential to comprehend the scope and length of commissioning activities and include them in the initial project plan and budget allocations. The cost of process instrument commissioning is typically affected by the following issues: learning and familiarizing with the field device. in fact. Some companies employ specialized commissioning engineers.intelligent commissioning There are many reasons why instruments should be calibrated during the commissioning phase before start-up. plant operation and plant maintenance. and adverse incidents at the start-up phase can be avoided. it may cost more. and ensure this commitment is maintained. An extra day taken for commissioning means the same to the plant owner as an extra day taken during designing or construction. prior to operating equipment. 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. Management. physically installing the field device. Commissioning requires a team of people with a background in plant design.
Good planning. documentation.g. The commissioning team consists of a mixture of specialists. and the size of the team and composition of specialists depends on the nature and scope of the system. Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. of commissioning is measurable (e. number of loops or sequence of steps tested per day). Calibration and the commissioning of field instrumentation New process instrumentation is typically configured and calibrated by the manufacturer prior to installation. such as the Beamex® CMX Calibration Software.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. thereby enabling progress to be reviewed regularly. communications. Sequence of activities leading to commissioning and acceptance of a plant. teamwork and training are all essential. However. instrument and process engineers. coordination. instruments are often recalibrated upon arrival at the site. especially if there has been obvious 109 .
The calibration database can be calibration software designed specifically for managing calibration assets and information. the calibration serves also future purposes. such as the Beamex® CMX Calibration Software. 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. By calibrating an instrument you can check the settings of the instrument. Calibrating a new instrument before installing or using it is a quality assurance task. The trick is determining which sensors should be recalibrated after a few hours. specified settings. as well as to monitor the instrument’s stability. as was explained in the previous paragraph. weeks. the fact that an instrument or transmitter is new does not automatically mean that it is within required specifications. specified settings. it is possible to monitor the stability of the transmitter. After you have performed this task. weeks. There are also many other reasons why instruments should be calibrated during the commissioning phase before start-up. By calibrating the transmitter before installation and on a regular basis thereafter. it is possible to reconfigure the transmitter. or years of operation and which can be left as is for 110 . The transmitter information is critical in defining the quality of the instrument and for planning the optimal calibration interval of the instrument. when the initial planned specifications have been changed. Calibration is therefore a key element in the process of reconfiguring an uninstalled transmitter. You can check the overall quality of the instrument to see if it is defective and to ensure it has the correct. However. 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. Transmitters that are found to be highly stable need not be recalibrated as often as transmitters that tend to drift. Reconfiguring a transmitter The trick is determining which sensors should be recalibrated after a few hours. The new uninstalled instrument or transmitter may have the correct.intelligent commissioning damage in transit or storage. it is possible that the original planned settings are not valid anymore and they need to be changed. Monitoring the quality and stability of a transmitter When calibration procedures are performed for an uninstalled instrument.
Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks do not get forgotten. The Beamex® CMX can be used for planning and scheduling calibrations. Engineers performing calibrations no longer have to write down any results on paper. does anyone perform the calibration (check in/out function) and what is the instrument/position status (pass/fail). managing and storing all calibration data as well as analyzing and optimizing the calibration interval. thereby eliminating unnecessary calibration work. smarter and more accurate management of all calibration assets and procedures. making the entire process much quicker and reducing costs. are they installed and ready for calibration. productivity and cost-effectiveness of a plant’s calibration process. The Beamex calibrators are all-in-one calibrators. such as analog. overlooked or become overdue. Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important. electrical and frequency signals. improves the quality and efficiency of the entire calibration system through faster. The Beamex® MC series documenting calibrators can be used for calibrating pressure. The Beamex® CMX Calibration Software can be used for improving the quality. Integrated calibration solution by Beamex The Beamex® Integrated Calibration Solution. 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. 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. By using a documenting calibrator. the calibration results are stored automatically in the calibrator’s memory during the calibration process. Therefore. Using the CMX gives always a clear status of the transmitters. The Beamex calibrators support various different transmitter protocols. Doing so allows maintenance personnel to concentrate their efforts only where needed. overlooked or become overdue. consisting of calibration software and documenting calibration equipment. 111 . which mean that they can be used to replace several individual measurement devices. Foundation Fieldbus and Profibus. temperature. Intrinsically safe calibrators for potentially explosive environments are also available. for instance.intelligent commissioning longer periods without sacrificing quality or safety. HART.
intelligent commissioning By using a documenting calibrator. 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. as there are fewer mistakes due to human error. 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. again. therefore automatically produced when using the Beamex® Integrated Calibration Solution. The quality and accuracy of calibration results also improve. saving time and money. 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 . This means that engineers do not spend their time transferring the results from their notepad to final storage on a computer.
including pharmaceuticals. especially if the company is part of an asset-intensive industry. perhaps resulting in costly production downtime. Beamex’s calibration management software. metal processing. is critical to business efficiency. If stoppages to production lines due to equipment breakdowns are costly. or across multiple sites. profitability and growth. flow meters and the like – are performing and measuring to specified tolerances. Beamex® CMX. but critical part of a company’s asset management strategy should be the calibration of process instrumentation. In the process industries. a small. which then have to be scrapped. where equipment and plant infrastructure is large. If sensors drift out of their specification range. pressure transducers. conveyor systems or hydraulic pumps – is equally critical for these companies. boilers. special purpose machines. the consequences can be disastrous. complex and expensive. nuclear. Manufacturing plants need to be sure that their instrumentation products – temperature sensors. safety issues or batches of inferior quality goods being produced. chemicals. implementing the latest computerized maintenance management systems (CMMS) might save precious time and money. paper. having a reliable.successfully executing a system integration project Successfully executing a system integration project F or process manufacturers today. has proved itself time and time again across many industry sectors. In the process industries. seamlessly integrated set of IT systems across the plant. furnaces. 115 . For this. oil and gas. Maintenance management has become an issue which deserves enterprise-wide and perhaps multi-site attention. Maintaining plant assets – whether that includes production line equipment. a small. but critical part of a company’s asset management strategy should be the calibration of process instrumentation.
CMX also stores the complete calibration history of process instruments and produces fully traceable calibration records. CMX can also download detailed instructions for operation before and after calibrating. As well as retrieving and storing calibration data. Integration project A customer may have a large CMM system and a considerable amount of data keying to perform before integration is complete. schedule. Then. analyze and optimize their calibration work. like procedures. the customer and the CMM system software partner. most process manufacturers use some sort of computerized maintenance management system (CMMS) that sits alongside their calibration management system.successfully executing a system integration project Seamless communication Today. plan. reminders and safety-related information. in-house software for maintenance management. elimination of human error associated with manual recording. 116 . whether it is a Maximo. in-house software for maintenance management. CMX sends an acknowledgement order of this work back to the customer’s CMM system. Beamex® CMX helps companies document. Calibration work orders can easily be transferred to CMX Calibration Software. The integration project involves three main parties: Beamex. 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. A data exchange module or interface that sits between the two systems is required. Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems. Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems. Seamless communication between CMX and ‘smart’ calibrators means that companies have the ability to automate predefined calibration procedures. once the calibration work order has been executed. All detailed calibration results are stored and available on the CMX database. SAP or Datastream CMM system or even a company’s own. Seamless communication with calibrators also provides many practical benefits such as a reduction in paperwork. whether it is a Maximo. SAP or Datastream CMM system or even a company’s own. and the ability to speed up the calibration task.
a project steering group may need to be established. as a successful project requires input from both parties. the customer and the CMM system software partner. agreement. Development and Implementation 3. it’s important that the right people and decision-makers are involved and participate right from the beginning of the project. In addition.successfully executing a system integration project Project organization and resourcing In order to have a successful integration. Each project phase should be approved according to the acceptance procedures defined in the offer. Verification and Training The four main phases are also often divided into sub-phases. It’s also essential that the main roles and responsibilities of the parties are specified before the project evolves. a project organization should be established and include members from both the supplier’s and the customer’s organization. The project steering group is responsible for making key decisions during the project. Testing 4. The integration project involves three main parties: Beamex. Project phases The integration project is divided into four main phases: 1. Installation. Moreover. 117 . The role. The role of each member should be defined and project managers appointed. The project manager is usually responsible for the operative management of the project. Scope of Work 2. project plan or other document annexed to the offer / agreement. tasks and authority of the project steering group must be defined as well as the decision-making procedures. A schedule is usually defined for the completion of the entire project as well as for the completion of each project phase.
as changes to the original scope of work may be necessary and required even in projects where the SOW phase has been done carefully. which will direct the project back to phase one where a review of the scope is necessary. scheduling and costs of the project depend greatly on the scope of work. partner responsibilities and the desired outcome. The SOW is often developed through pre-studies and workshops. However. main roles. questions or problems may appear later in the project. 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. If the scope of work is not defined carefully. The scope of work should include a brief project description. Defining what is not included in the scope of work is just as important as defining what is included in it. This means that establishing some framework and limitations for the project are also very important. 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. services provided. defining the correct scope of work (SOW) is crucial. 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.successfully executing a system integration project Scope of work To ensure successful integration with a satisfied customer. 118 .
training and providing training materials. the customer has a system that saves time. assist with informing. 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. When the integration is finished. in order to be able to continue the development work to next phase. The testing. Testing Testing occurs both during the project after each partial delivery. the integration can enter the next phase. which is the actual development and implementation of the project deliverables. the customer has a system that saves time. The project manager at the buyer’s facility now plays a major role in the success of the integration process. 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. Installation. and at the final stage of the project. approval procedures and timelines should be defined when agreeing on the project. The supplier will. • 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 . reduces costs and increases productivity by preventing unnecessary double effort and rekeying of procedures in separate systems. if required and agreed.successfully executing a system integration project Development and implementation When the scope of work has been defined and approved by both parties.
and optimized scheduling of maintenance tasks and resources. EAM is more than just maintenance management software. a corresponding increase in asset utilization or plant uptime. typing errors are eliminated. Savings from EAM are reasonably well-documented and come in various guises.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. 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. A CMMS integration will enable the customer company to automate its’ management with smart calibrators. Enterprise Asset Management. 120 . But the key to success is really the quality of information you put in the software. more efficient use of maintenance staff. However. better management of spare parts and equipment stocks. When there is no need to manually re-key the data. Integrating a CMM system with calibration management software is an important step in the right direction when it comes to EAM. particularly with production teams. the data has to be as close to 100% accurate as possible to get maximum benefit from the system. systems. This improves the quality of the entire system. Enterprise Asset Management.
Calibration in Industrial Applications .
Indeed. Foundation Fieldbus or Profibus output of the transmitters and can even be used for configuring ‘smart’ sensors. The purpose of calibration itself is to determine how accurate an instrument or sensor is. temperature and electrical signals. regular calibration of instruments throughout a manufacturing plant is common practice. the key final step in any calibration process – documentation – is often neglected or overlooked because of a lack of resources. 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. and then automatically documenting the calibration results by transferring them to a fully integrated calibration management software. In plant areas where instrument accuracy is critical to ensure product quality. time constraints or the pressure of everyday activities. However. 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. safety or custody transfer. calibration every six months – or even more frequently – is not unusual. 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. Some calibrators can read HART.the benefits of using a documenting calibrator The benefits of using a documenting calibrator F or process manufacturers. including frequency and pulses. 125 . 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. Although most instruments are very accurate these days.
Also. “Engineers.the benefits of using a documenting calibrator Heikki Laurila. Performing the calibration procedure in the same way each time is important for the consistency of results. the calibration results are stored automatically in the calibrator’s memory during the calibration process. spreadsheet or paper filling system. the calibration procedure itself is critical. Why use a documenting calibrator? The engineer does not have to write any results down on paper. “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. which makes the entire process much faster and consequently reduces costs. but which also integrates and automatically transfers this information to some sort of calibration management software. receive instant pass or fail messages with a documenting calibrator. such as the 126 . saving time and money. The quality and accuracy of calibration results will also improve. the calibration procedure can be automatically transferred from the computer to the handheld calibrator before going out into the field.” With a multi-functioning documenting calibrator. or stores calibration data from instruments but is not integrated to a calibration management system. As Laurila states. The calibration results are automatically transferred from the calibrator’s memory to the computer/database. Calibration results have to be keyed manually into a separate database. Product Manager at Beamex in Finland comments. as well as detailed instructions on how to calibrate the transmitter. With instrument calibration. who are out in the field performing instrument calibrations. The engineer does not have to write any results down on paper. again. With a documenting calibrator. The tolerances and limits for a sensor. especially if calibration is one of the many tasks that the user has to carry out in his daily maintenance routine.” A non-documenting calibrator is a device that does not store data. 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. are entered once into the calibration management software and then downloaded to the calibrator. By using a documenting calibrator. having an easy-touse documenting calibrator is definitely the way forward. This means the engineer does not have to spend time transferring the results from his notepad to final storage on a computer. which makes the entire process much faster and consequently reduces costs. as there will be fewer mistakes due to human error.
Oftentimes. Benefits in practice Conventional calibration work relies on manual. the user can download calibration instructions for hundreds of different instruments into the device’s memory before going out into the field. configure and trim HART.the benefits of using a documenting calibrator Beamex® MC5 or MC6. speed and accuracy are critical. Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. the user doesn’t need to carry as much equipment while out in the field. Manual calibration takes more time and is more prone to error. This means the user can work in the field for several days. Foundation Fieldbus H1 or Profibus PA transmitters. handwrites the results onto a paper form and then reenters this information into a database when he returns to the office. 2004 Calibration software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. overlooked or overdue. the calibration process is much faster. 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. Laurila continues. “With a documenting calibrator. ___________________ * Reported to the Industrial Instrumentation and Controls Technology Alliance and presented at the TAMU ISA Symposium. 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 % . such as the MC5 or the MC6.” Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important. 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. overlooked or overdue. When you’ve got to calibrate instruments throughout a site. Unintentional errors often occur and the whole process is timeconsuming. 127 . paper-based systems for documenting. typically with five-point checks on each instrument. and the system provides full traceability.* Why? Because the devices provide higher accuracy. January. Both calibrators can be used also to calibrate. the field engineer calibrates the instrument.
• Less paperwork and fewer manual errors. • No manual printing or reading of calibration instructions is required. This not only ensures full traceability but also reflects full and traceable documentation of the completed work. 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. • Calibration results are automatically stored in the calibrator’s on-board memory during the calibration procedure. saving time and money and simplifying the process. again. • 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. the system provides a full quality assurance report of all instruments calibrated along with a required calibration certificate. • Reduced costs from a faster and more efficient calibration process. 128 .the benefits of using a documenting calibrator After completing instrument calibrations. • A fully traceable calibration system for the entire plant. • Improved accuracy. • Calibration results are automatically transferred from the calibrator’s memory to a computer or fully integrated calibration management system.
and the user must have the knowledge to apply the information achieved through calibration. usually called scales or balances. Verification and calibration abide by a different philosophy. How the weighing instrument is used and how reliable the weighing results are can be very different. 131 . (S)He must select the weighing instrument and maintenance procedure to be used to reach the required measurement capability. Calibration and legal verification Weighing instruments may also possess special features. whereas verification depicts the In any case. Calibration depicts the deviation between indication and reference (standard) including tolerance. for example when invoicing is based on the weight of a solid material. the user must define the measurement capability of it. weighing instruments. but in the EU they are the same. Using weighing instruments for legal purposes must have legal verification. at least at the stage when the weighing instrument is being introduced into use. In any case. 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. The features may vary slightly from country to country. should provide the correct weighing results. If a weighing instrument is used in a quality system.calibration of weighing instruments part 1 Calibration of weighing instruments Part 1 F rom the point of view of the owner. the quality of a weighing instrument is already defined in OIML regulations. at least in Europe. 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. From a regulatory point of view. Calibration is a means for the user to obtain evidence of the quality of weighing results. One of these features includes making measurements for which legal verification is required.
Comparing the indication of weighing instruments with a set standard gives the deviation or error. if necessary. as long as legal verification is not needed. hysteresis.calibration of weighing instruments part 1 maximum permissible amount of errors of the indication. and. produces a calibration certificate – is the best way to achieve reliable information to use in comparisons. In practice. The practical work for both methods is very similar and both methods can be used to confirm measurement capability. 132 . we need more information about the weighing instrument. and it displays the history of calibrations and in this way provides the user with comprehensive information concerning measuring capability. Using a calibration program. We must remember that the quality of the evaluation of measuring tolerance depends on the collected information through calibration. including information for other measuring devices. and for weighing technology in general. This is a feasible practice for all weighing. 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. The method of calibration should be selected such that it provides sufficient information for evaluating the required measuring tolerance. this means investigating the efficiency of the weighing instrument. this operation is known as calibration (or verification). etc. eccentric load. This type of program is able to store all the history of calibrated weighing instruments. even if it was a question of general weighing (non-legal). which goes through the same steps for every calibration – calculates deviation and measuring tolerance. One calibration provides information on a temporary basis and a series of calibrations provides time-dependent information. are based on these practices of calibrating and verifying. The terminology and practices used previously for verifying measurement capability. However. The method should be precise for achieving comparable results during all calibrations. 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. It is also handy for monitoring measuring systems. Confirming the capability of weighing instruments should happen by estimating the quality of the measuring device in the place where it will be used. such as repeatability. to be able to define the measuring tolerance.
an adjustment or maintenance is necessary. 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. a quality system is usually concerned with the traceability of measurements and the known measuring tolerance of the measurements made. are familiar with these parameters and use them as protocol. Calibration itself. Calibration itself. however. They possess several possibilities for adjusting parameters in measuring procedures. as well as calibration personnel. Performing calibrations based on the measuring tolerance is better than doing routine measuring. the idea is that the weighing instrument remains in good working condition until the next calibration. 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. It is very important that the users of the weighing instruments. as well as many other instruments. however. The user must define the limits for permitted deviation from a true value and required measuring tolerance. However.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. Therefore. regular monitoring of the zero point and the indication number with a constant mass. it is important to always have the manual for using the weighing instrument easily available to the user. 133 . 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. Calibration should be carried out using settings based on the parameters for normal use. Today. the function of weighing instruments. If these values are exceeded. Since there are several parameters in use. is based on microprocessors. the idea is that the weighing instrument remains in good working condition until the next calibration. is a short-term process. For this reason. is a short-term process. the user must determine all of the external factors which may influence the proper functioning of the weighing instrument. the user must evaluate the process of measuring tolerance and compare this value with the required measuring tolerance of the process.
134 .calibration of weighing instruments part 1 SUMMARY Calibration (or verification) is a fundamental tool for maintaining a measuring system. 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 1 135 .
often need to know just how inaccurate a particular scale may be. 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. this information was obtained by classifying and verifying the equipment for type approval. tests for determining minimum weighing capability are also performed. i. 137 . which was prepared by the European Co-operation for Accreditation. often need to know just how inaccurate a particular scale may be.e. but users. industries and households.and/or industry-specific guidelines or regulations. Typical calibration procedures Calibrating scales involves several different procedures depending on national. their customers and/or regulatory bodies. Originally. and published by the European Collaboration in Measurement and Standards (euromet). One clear and thorough guide is the EA-10/18. the object being weighed is placed on the load receptor and the weighing result is read only once. If you weigh the object Weighing instruments are often highly accurate. Subsequently. their customers and/or regulatory bodies. i. Repeated weighing measurements provide different indications Usually. but users. the equipment was tested or calibrated on a regular basis. Weighing instruments are often highly accurate. or on the potential consequences of erroneous weighing results. Guidelines on the Calibration of Non-automatic Weighing Instruments.calibration of weighing instruments part 11 Calibration of weighing instruments Part 2 W eighing is a common form of measurement in commerce.e.
Combined standard uncertainty of the error U(E) Knowing the error of the scale indication at the point of each calibration is not sufficient. often need to know just how inaccurate a particular scale may be.e. In such a case. suitable substitution mass is used instead.calibration of weighing instruments part 11 repeatedly. If the scale’s maximum load limit is extremely large. You must also know how certain you can be about the error found at each point of calibration. A truck scale is unsuitable for weighing letters The purpose of the minimum weight test is to determine the minimum weight.g.: Weighing instruments are often highly accurate. Typical calibration procedures include the eccentricity test. with a probability of 99. This is sometimes difficult due to the shape or construction of the object being weighed. The repeatability test involves weighing an object several times to determine the repeatability of the scale used.1% of the weight. Center of gravity matters The eccentricity test involves placing the object being weighed in the middle of the load receptor as accurately as possible. random variation in the indications. 138 . There are several sources of uncertainty of the error. but users. Substitution mass should also be used if the construction of the scale does not allow the use of standard weights. 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.73%. it may be impractical to use standard weights for calibrating the entire range. i. This condition is met if the measurement error is less than 0. their customers and/or regulatory bodies. you will notice slight. 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. which can be assuredly and accurately measured using the scale in question.
which correspond to one standard deviation of a normally distributed variable. • Air convection causes extra force on the load receptor. • There are random variations in the indications as can be seen in the Repeatability Test. 139 .1 g 2. is between is between 1. • Analogous scales have limited readability.5 g ±u(E) 68. with a coverage probability of 68. • Digital scale indications are rounded to the resolution in use.73 % 3.calibration of weighing instruments part 11 • The masses of the weights are only known with a certain uncertainty. The combined standard uncertainty of the error at a certain point of calibration has a coverage probability of 68.27%. air temperature and humidity.9 g 4. • Air buoyancy around the weights varies according to barometric pressure. E = 2. • A substitute load is used in calibrating the scale. The values of uncertainty determined at each point of calibration are expressed as standard uncertainties (coverage probability: 68. • The weights are not in the exact middle of the load receptor. which means that the calculated error in the indication is 2.2 g. 1.7 g.27% as well.27%).8 g and 3.g.6 g Example: The calibration error and its uncertainty at the calibration point of 10 kg may be expressed e.5 g and u(E) = ±0.2 g 3.45 % U(E) = 3u(E) 99.8 g 0.5 g and the actual error.4 g 1.27% U(E) = 2u(E) 95.
• Loading/unloading cycles in calibration and routine weighing may be different. while calibration is made at certain calibration points.45%. then a larger value should be used for the k-factor. • Tare balancing device may be used in routine weighing. This means that the calculated error of the indication is 2. with a coverage probability of 95. • A load may be situated eccentrically in routine weighing. for all The purpose of calibration is to determine how accurate a weighing instrument is. Typical reasons for this are: • Routine weighing measurements involve random loads.27% is insufficient. Standard and expanded uncertainties of weighing results are calculated using technical data of the weighing instrument. If you are able to use the k = 2 coverage factor. it is extended to a level of 95. • The temperature. Uncertainty of a weighing result The purpose of calibration is to determine how accurate a weighing instrument is. then the error and its extended uncertainty at the point of calibration are E = 2. a coverage probability of 68. the indication of weighing an object of 10 kilograms will be between 10. • Routine weighing measurements are not repeated whereas indications received through calibrations may be averages of repeated weighing measurements. Defining the uncertainty of weighing results is highly recommended. barometric pressure and relative humidity of the air may vary.1 g and 3. However. or the reliability of the standard uncertainty value is insufficient. knowledge of its typical behaviour and knowledge of the conditions of the location where the instrument is used. As the above-mentioned case indicates.calibration of weighing instruments part 11 Expanded uncertainty in calibration U(E) In practice. its calibration results.0039 kg 95. is between 1. • The adjustment of the weighing instrument may have changed. • Finer resolution is often used in calibration. Normally. the uncertainty of the results of later routine weighings is usually larger.45% of the time. you know that if you repeat the calibration several times. at least once.0011 kg and 10.5 g and the actual error.4 g.5 g and U(E) = ±1. 140 . If the distribution of the indicated error cannot be considered normal.45% by multiplying it with the coverage factor k = 2.9 g.
141 . Wide variation in user-specific limits is also possible. CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument. However. It allows you to enter additional.calibration of weighing instruments part 11 typical applications and always for critical applications. Correspondingly. copying configurations from one scale to another is easy. CMX’s versatile calibration certificate and possibility to define a user specific certificate assure that you can fulfill requirements set for your calibration certificates. user-defined uncertainty components in addition to supported uncertainty components. 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. determining the uncertainty of weighing results is not part of calibration. Calibrating and testing weighing instruments using CMX CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument. CMX calculates combined standard uncertainty and expanded uncertainty at calibration of the weighing instrument. Error limits can be set according to OIML or Handbook-44.
T/C). Temperature greatly influences many physical features of matter. Every temperature measurement is different. makes it different from other quantities. RTD) or convert temperature into low voltage (Thermocouples. which makes the temperature calibration process slow and expensive. A temperature measurement consists of several time constants and it is crucial to wait until thermal equilibrium is reached before measuring. the user must be sure to verify the permanency of accuracy. and its influence on e. they nevertheless do not determine the permanency of accuracy. show incorrectly. While standards determine accuracy to which manufacturers must comply. It is important to keep in mind an old saying: all meters. it is necessary to calibrate the instrument and the temperature sensor. Temperature. If temperature is a significant measurable variable from the point of view of the process. For each measurement. Metrology contains mathematic formulas for calculating uncertainty. being a state of equilibrium. calibration will prove by how much. Temperature sensors The most commonly used sensors in the industry used for measuring temperature are temperature sensors.g. they nevertheless do not determine the permanency of accuracy. Therefore. energy consumption and environmental emission is significant. a model that includes all influencing factors must be created. RTD’s are based While standards determine accuracy to which manufacturers must comply. 143 . The polynoms are specified in ITS 90 table (International Temperature Scale of 1990).calibrating temperature instruments Calibrating temperature instruments T he most commonly and most frequently measurable variable in industry is temperature. including sensors. They either convert temperature into resistance (Resistance Temperature Detectors. quality.
Many factors influence the total uncertainty. while the transmitter converts the sensor signal. All heat 144 . and therefore the transmitter must be calibrated on regular basis. To make comparisons. an external reference temperature sensor is recommended. the noble thermo-elements S-. it also has an impact on the total accuracy. such as Fieldbus transmitters. the transmitter converts the signal from the temperature sensor into a standard ranging between 4 and 20 mA. The most important criterion in the calibration of temperature sensors is how accurate the sensors are at the same temperature. temperature transmitters were developed to convert the sensor signal into a format that can be transmitted easier. Temperature transmitters The signal from the temperature sensor cannot be transmitted a longer distance than the plant. a small temperature dependent voltage difference/current can be detected.calibrating temperature instruments on the fact that the resistance changes with temperature. PtRh/Pt/Rh) are used especially in high temperatures for better accuracy and stability. R. Thermocouple consists of two different metal wires connected together. The most common T/C type is the K-type (NiCr/NiAl). The heat source may also have an internal temperature measurement that can be used as reference. Therefore. The uncertainty of calibration is not the same as the accuracy of the device. Despite their lower sensitivity (low Seebeck coefficient). This means that the thermocouple is not measuring the temperature. it must be inserted into a known temperature. are also being adopted. A temperature transmitter can be calibrated using a temperature calibrator. Sensors are calibrated either by using temperature dry blocks for industrial field or liquid baths (laboratory). Most commonly. we compare the sensor to be calibrated and the reference sensor. transmitters with a digital output signal. Calibrating temperature instruments To calibrate a temperature sensor. Nowadays. If the connections (hot junction and cold junction) are at different temperatures. but to achieve better accuracy and reliability.or B-type (PtRh/Pt. and performing calibration is not the least influencing factor. but the difference in temperature. The most important criterion in the calibration of temperature sensors is how accurate the sensors are at the same temperature. Pt100 is a common RTD type made of platinum and its resistance in 0 ˚C (32 ˚F) is 100∧.
affects both the reference sensor and the unit being tested. Radial homogeneity Radial homogeneity can be explained as the difference in temperature occurring between the borings. The major sources of measurement uncertainty are axial homogeneity. 145 . Thirty minutes is commonly used.01 (former EA-10/13). loading effect. This phenomenon is called loading effect. Stem conduction. heat flux along the length of the thermometer stem. Measurement uncertainty Axial homogeneity Axial homogeneity is the temperature distribution in the measurement zone along the boring (axial temperature distribution). Stability Stability means variation of the temperature in the measurement zone over time when the system has reached equilibrium. These effects can be quantified to determine the heat source’s contribution to the measurement uncertainty. radial homogeneity. The uncertainty of calibration is not the same as the accuracy of the device. the immersion depth for a probe should be sufficient for the sensor being calibrated. stability and immersion depth. Immersion depth To achieve a more stable calibration.calibrating temperature instruments sources show measurement errors due to their mechanical design and thermodynamic properties. Loading effect When several sensors are placed in the borings of the heat source. they will affect accuracy. Guidelines for minimizing measurement uncertainty should be applied according to Euramet/cg-13/v.
regular calibration of sensors and traceable calibration as well as calibration documentation. says Raimo Ahola. The calibration results can then be uploaded from the documenting calibrators to the Beamex® CMX Calibration Software. However. the calibration device must always be more accurate than the instrument or sensor being calibrated. “The temperature products and services we are now introducing form an integral part of the Beamex® Integrated Calibration Solution. a complete calibration solution that enables faster. The Beamex® Integrated Calibration Solution concept is the combination of calibrator. both in numeric and in graphic form. 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 level of performance a calibration device needs to have depends on the accuracy requirements determined by each company. The dry blocks communicate with the Beamex documenting multifunction calibrators enabling fully automated temperature calibration and documentation. determining service in advance and recalibration. calibration software and PC for online calibration. The ISO quality control system presupposes the quality control of calibration. The instrument’s calibration information is saved in the calibrator and History Trend reports. 146 . more efficient and accurate solution for calibrating temperature. 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. the calibration of instruments effecting production. the calibration device must always be more accurate than the instrument or sensor being calibrated. where the computer controls the calibration event. such as a series of highquality dry blocks for field and laboratory use. With the CMX Software. Integrated calibration solution – a smarter way to calibrate temperature Beamex has introduced a smarter. which is useful in making decisions about purchasing new instruments.calibrating temperature instruments The calibration of instruments and sensors must be performed periodically. smart reference probes and temperature calibration laboratory services. Calibration of instruments and sensors can be carried out either on site or in a laboratory. However. CEO of Beamex Group. more accurate and efficient management of all calibration assets and procedures”. The Beamex® FB and MB dry blocks are part of the Beamex® Intergrated Calibration Solution.
Our integrated calibration solution concept saves valuable time.calibrating temperature instruments accredited calibration certificate. Mr Ahola adds. eliminates any errors related to manual entry and assures repeatable calibration procedures”. calibration software and PC for online calibration. The Beamex® Integrated Calibration Solution concept is the combination of calibrator. 147 .
There are fast and lightweight dry blocks for industrial field use as well as models that deliver near bath-level stability in laboratory use. but they don’t necessarily improve performance. in temperatures above 200 °C liquids can produce undesirable fumes or there may be fire safety issues. 149 .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. They may actually even impede the dry block’s performance and damage its internal components. For example.01. What is a temperature dry block? A temperature dry block consists of a heatable and/or coolable metallic block. it could even cause a small steam explosion which may splash hot oil on the user. Heat transfer fluids or pastes are sometimes used around or inside the insert. 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. an internal control sensor and optional readout for external reference sensor. It will also present how to calculate the total uncertainty of a calibration performed with a dry block. This article will focus on models that use interchangeable metallic multi-hole inserts. There are also some work safety issues that favor dry blocks in preference to liquid baths. If a drop of water gets into hot silicon oil. controller. Dry blocks are almost without exception meant to be used dry. EURAMET The EURAMET guideline (EURAMET /cg-13/v.
total uncertainty of temperature calibration dry blocks. Internal measurement as reference When using a dry block’s internal measurement as reference. the products are easier to compare. 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 Euramet calibration guide defines a normative way to calibrate 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. With dry blocks. Some manufacturers specify these components and some do not. • 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. As most of the manufacturers nowadays publish their product specifications including the main topics in the Euramet guide. the internal control sensor is typically located inside the actual block. whereas the probes to be calibrated are immersed in the insert. 150 . 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.5 mm at –80…660 °C) (<= 1. or to use an external reference temperature probe inserted in the block as a reference measurement. It is possible to use a dry block with the block’s internal measurement as the reference (true value).
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. a homogenous zone of at least 60 mm is recommended. The Euramet calibration guide states. The purpose of this homogenous measurement zone is to cover various sensor constructions. Related uncertainty is caused. “dry wells should have a zone of sufficient temperature homogeneity of at least 40 mm in length” at the bottom of the insert. 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. With this in mind. • Radial uniformity Radial uniformity refers to the variation in temperature between the holes of the insert. Non-symmetrical loading or probes with significantly different thermal conductivity (for example large diameter probes) may cause additional temperature variation. thermal properties of materials and alignment of the insert holes. 151 . for example. • Axial uniformity Axial uniformity refers to the variation in temperature along the vertical length of the insert. by the placement of the heaters.
The Euramet calibration guide states that the immersion depth should be at least 15 x the probe’s outer diameter.). – The Euramet calibration guide defines stability as a temperature variation over a 30-minute period. the more the ambient temperature will affect the measurements. The more the load. to use immersion depth of 20 x the diameter. when the system has reached equilibrium. 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. • Immersion Sufficient immersion is important in any temperature measurement. • Hysteresis Hysteresis causes the internal sensor to be dependent on its previous exposure. • Stability over time – Stability describes how well the temperature remains the same during a given time. wall thickness. The hysteresis is greatest at the mid-point and is proportional to the temperature range. The loading effect is not visible in the control sensor indication and the controller cannot completely compensate for this shift. Sufficient immersion depth and dual zone control helps to reduce load-related uncertainties. If sufficient recommended immersion cannot be reached. a test for each individual probe type to be calibrated should be made.total uncertainty of temperature calibration • Loading effect Every probe in the insert conducts heat either from or into the insert. as a rule of thumb. As the probe constructions vary greatly (sheet material. To minimize the stem conduction error it’s recommended. 152 . then the uncertainty caused by the insufficient immersion should be estimated/ evaluated. If some component has not been specified. Stability describes how well the temperature remains the same during a given time. it should be estimated or evaluated. The specifications for the above uncertainty components should be in the block’s specifications. lead wire thermal conductivity etc.
It helps to minimize calibration uncertainty but also provides reliability in measurements. the external reference sensor is within the same calibration volume as the sensors to be calibrated. the external reference sensor is inside the insert together with the probes to be calibrated. The internal sensor is used just to adjust temperature close to the desired calibration point and keep it stable. the stem conductance has to be taken into account. If the reference sensor and the sensor to be calibrated are sufficiently similar in diameter and thermal conductivity. the user can reduce the axial uniformity well below specification. the reference probe can be drawn out to match the immersion. Using an external reference sensor enables more accurate measurement of the temperature of the probes to be calibrated. the user may obtain good results. the external reference enables more accurate measurement of the temperature of the probes to be calibrated. mechanical robustness is usually inversely proportional to good performance: stability. In case the probe to be calibrated is short and won’t reach the measurement zone at the bottom of the insert. • Loading effect Since the internal sensor cannot completely compensate the load related temperature shift inside the insert. 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. • Radial uniformity Radial uniformity is still present when using an external reference probe and should be taken into account as specified. In many cases. Using an external reference sensor enables smaller total uncertainty of the system. There are many advantages to using a separate reference sensor. etc. Therefore. hysteresis. In the case of using an external reference sensor. Unfortunately. Of course. The internal sensor has to deal with quick temperature changes. vibration and possible mechanical shocks so it has to be quite a robust mechanically. The loading effect is usually much less significant with an external reference sensor.total uncertainty of temperature calibration Using an external reference sensor as reference Unlike using the dry block’s internal sensor as a reference. 153 .
and it may often be smaller than the specification. the different loads. stem conduction. 154 .total uncertainty of temperature calibration • Stability over time The external reference sensor can be used to measure the actual temperature deviation inside the insert. It also helps the user to see when the unit has truly stabilized. but depending on. the external reference sensor needs a unit that measures the sensor. 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. It can be the block or an external device. All of the previously mentioned uncertainty factors need to be carefully considered. – Uncertainty related to the reference probe components includes the probe’s calibration uncertainty. for instance. using an external reference does not automatically mean better results. hysteresis. • External reference sensor – The external reference sensor (PRT) is typically much more capable of producing accurate measurements than the internal sensor. – Of course. and the readout device’s uncertainty. Dry blocks usually have a stability indicator. However. drift. there may still be some difference between the block and the insert temperatures when the indicator shows the unit has stabilized.
As can be seen in the examples the total expanded uncertainty using the internal reference sensor is 135 mK (0.004 0.025 0. The standard uncertainties are combined as the root sum of the squares.010 0.003 0.028 All specifications have a rectangular probability distribution. The temperature in both examples is 0 °C.005 0.006 0.005 0.10 0.135 MB155R with external measurement @0 °C Component Axial Uniformity Radial Uniformity Stability Loading Effect Ref sensor measurement Specification (°C) 0.total uncertainty of temperature calibration CALCULATION EXAMPLES ■ Here are two examples of total uncertainty calculations.007 0.02 0.014 0.007 0.135 °C).014 0.029 0.003 0.005 0.020 Standard Uncertainty (°C) 0.012 0.003 0.01 Combined Uncertainty: Expanded Uncertainty: MB155R and RPRT-420 Combined uncertainty: Expanded Uncertainty: 0.01 0.067 0. they are divided by the square root of three to get the Standard Uncertainty.003 0. In both cases the MB155R is used as the dry block.006 0. Finally the combined uncertainty has been multiplied by two to get the expanded uncertainty.02 0. That is why they are divided by the square root of three to get Standard Uncertainty.012 0.034 °C).034 Standard Uncertainty (°C) 0.006 0.01 0.017 0. The various uncertainty components used in the examples can be found in the specifications in the product brochures. MB155R with internal measurement @0 °C Component Display Accuracy Hysteresis Axial Uniformity Radial Uniformity Stability Loading Effect Specification (°C) 0.058 0. Due to the rectangular probability distribution of the specifications. When using an external reference sensor the total expanded uncertainty is 34 mK (0.006 0. 155 . One is done using the internal temperature measurement and the other with a reference probe.006 Combined Uncertainty: Expanded Uncertainty: Reference Sensor (Beamex RPRT-420) Component Short-term repeatability Drift Hysteresis Calibration uncertainty Specification (°C) 0.004 0.05 Combined Uncertainty: Expanded Uncertainty: Standard Uncertainty (°C) 0.01 0.
The Fieldbus transmitters must be calibrated as well. the mA signal was introduced. Each transmitter needs a dedicated pair of cables. computerized control systems began to make their arrival. manufacturers battled to see whose fieldbus would be the one most commonly used. But what is fieldbus and how does it differ from conventional instrumentation? Fieldbus transmitters must be calibrated as well. During the 1960s. Several transmitters can be connected to the same pair of wires. instrumentation utilized mainly pneumatic signals to transfer information from transmitters. Conventional I/O systems are no longer needed because segment controllers connect the instrument segments to the quicker. smart transmitter was introduced in the 1980s. and throughout the 1990s a number of various fieldbuses were developed. higher-level fieldbus backbone. The first digital. Being an open standard.fieldbus transmitters must also be calibrated Fieldbus transmitters must also be calibrated F ieldbus is becoming more and more common in today’s instrumentation. Fieldbus transmitters are able to deliver a huge amount of information via the quick two-way bus. but how can it be done? Conventional transmitters can deliver only one simultaneous parameter. History of fieldbus Back in the 1940s. one way. During the 1990s. The first fieldbus was introduced in 1988. instruments from any manufacturer can be connected to the same fieldbus as plug-and-play. but how can it be done? 157 . In the 1970s. A standard was finally set in the year 2000 when the IEC61158 standard was approved. using first proprietary protocols. and I/O subsystems are required to convert the analog mA signal to a digital format for a control system. making things much easier.
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. Remote configuration also helps to support reduced downtime. one can say that the Foundation Fieldbus is dominating the North American markets and the Profibus is the market leader in Europe. Future of fieldbus Currently. The improved system performance is important criteria for some plants. lower installation labour cost. This is caused by many reasons. The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus market. Other areas are more divided. One important reason is the better return on investment. the total installation costs for a fieldbus factory is far less than conventional. Recent co-operation between Foundation Fieldbus and Profibus suppliers will further strengthen the position of these two standards. 158 . both used in process instrumentation. and no need for conventional I/O subsystems. There are also certain applications that prefer certain fieldbus installations despite the geographical location. Critical applications and hazardous areas have also begun to adopt fieldbus. were chosen as standards. or even a little bit more. Another big advantage is the on-line self-diagnostics that helps in predictive maintenance and eventually reduces the downtime. There are also other advantages compared to conventional instrumentation. For the most part. less planning/drawing costs.fieldbus transmitters must also be calibrated Foundation Fieldbus H1 and the Profibus PA. if it would not offer them benefits compared to alternative systems. The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus markets. A large portion of new projects is currently being carried out using fieldbus. offering maintenance savings. Fieldbus benefits for industry Obviously process plants would not start utilizing fieldbus. 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. Both Foundation Fieldbus and Profibus have reached such a large market share that both buses will most likely remain also in the future. such as reduction in field wiring.
such as quality systems and regulations. “calibration” is often used to mean the configuration of a transmitter. you need to find other ways to read the transmitter’s output. Also. Naturally these two people need to communicate with each other in order to perform and document the calibration. the total installation costs for a fieldbus factory is far less than conventional. In fieldbus terminology. Although modern fieldbus transmitters have been improved compared to older transmitter models.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. it is not possible to calibrate a fieldbus transmitter remotely. There are also many other reasons. Reading the digital output is not always an easy thing to do. 159 . 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. it does not eliminate the need for calibration. that make the periodic calibrations compulsory. or even a little bit more. 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. Although fieldbus hardware may cost the same as conventional. Changing the output signal does not change the need for periodic calibration. but you also need to have a way to read the output of the fieldbus transmitter. The other parts of a fieldbus transmitter are mainly comparable to conventional or HART transmitters. While your fieldbus and process automation systems are idle. In terminology pertaining to metrology. So it is not possible to calibrate a fieldbus transmitter using only a configurator or configuration software. The input is measured with a traceable calibrator. When fieldbus is up and running. Calibrating fieldbus transmitters The word “calibration” is often misused in the fieldbus terminology when comparing it to the meaning of the word in metrology. “calibration” means that you compare the transmitter to a traceable measurement standard and document the results. In some cases you can use a portable fieldbus communicator or a laptop computer with dedicated software and hardware.
The calibration results can be automatically stored into the memory of the MC6 or uploaded to calibration software. There is no need for an additional communicator. 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. 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.fieldbus transmitters must also be calibrated Fieldbus instruments are increasing in popularity and calibration can in many cases be cumbersome. 160 . The Beamex® MC6 will help to overcome these challenges by combining a full field communicator and an extremely accurate multifunctional process calibrator.
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. The vast majority of delivered instruments today are smart instruments. The term “smart” is more of a marketing term than a technical definition. produce diagnostics. A microprocessorbased smart transmitter has a memory that can perform calculations. etc. temperature. What is a “smart” transmitter? A process transmitter is a device that senses a physical parameter (pressure.) and generates an output signal proportional to the measured input. that will help to overcome these challenges. These new smart instruments bring new challenges to the calibration and configuration processes. There is no standardized technical definition for what smart really means in practice. etc. the digital communication protocol is the biggest difference compared to conventional transmitters. In any case. Furthermore. for the engineers who need to configure and calibrate the transmitter. Engineers can A modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. the Beamex® MC6 –Advanced Field Communicator and Calibrator. a modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. 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. in order for a transmitter to be called smart. Generally. 163 .configuring and calibrating smart instruments Configuring and calibrating smart instruments S o called “smart” instruments are ever more popular in the process industry.
This article will discuss “smart” transmitters. These parameters may include engineering unit. That brings a whole new challenge . The most common transmitter protocol today is the HART (Highway Addressable Remote Transducer) protocol. contain only a digital output. it is compatible with conventional installations. Configuration of a smart transmitter refers to the setting of the transmitter parameters. 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. Some are proprietary protocols of a certain manufacturer. a non-smart transmitter. would be a transmitter with a purely analog (or even pneumatic) output signal. Smart transmitter protocols There are various digital protocols that exist among transmitters considered smart. to support the selected protocol. typically also called a communicator.e. Since it also has the analog signal. etc. WirelessHART. It is crucial to remember that although a communicator can be used for configuration. you will need to use some form of configuration device. Foundation Fieldbus and Profibus are gaining a larger foothold on the process transmitter markets. but they need to have the possibility to communicate with the transmitter and read the digital signal. The configuration needs to be done via the communication protocol. sensor type. Configuration One important feature of a smart transmitter is that it can be configured via the digital protocol. including HART. Most of the protocols are based on open standards. it is not a reference standard and therefore cannot be used for metrological calibration.configuring and calibrating smart instruments no longer simply measure the output analog signal. such as Foundation Fieldbus and Profibus. Foundation Fieldbus and Profibus PA protocols. 164 . So in order to do the configuration.how can the digital output be read? Thinking of the opposite of a smart transmitter. A HART transmitter contains both a conventional analog mA signal and a digital signal superimposed on top of the analog signal. Recently the HART protocol seems to be getting more boosts from the newest WirelessHART protocol. The fieldbuses. i.
by using a calibrator. you will need some device or software able to read and interpret the digital protocol. The calibration may. The transmitter input needs to be generated/ measured the same way as with a conventional transmitter. be a very challenging task. which can read the digital output. it will automatically document the calibration results. Sometimes it is very difficult or even impossible to find a suitable device. you can generate or measure the transmitter input and at the same time measure the transmitter output. If the calibration is done with a documenting calibrator. potential adjustments are often included when the calibration process is performed.e. The 4–20mA output signal of a wired HART transmitter is calibrated the same way as a conventional transmitter. you need a dual-function calibrator able to process transmitter input and output at the same time. 165 .configuring and calibrating smart instruments It is crucial to remember that although a communicator can be used for configuration. To calibrate a conventional. by using a calibrator. but in order to see what the transmitter output is. especially a mobile one. be calibrated? Obviously the transmitter input still needs to be generated/measured the same way as with a conventional transmitter. i. However. For a real metrological calibration. to do any configuration or trimming. Although the calibration formally does not include any adjustments. i.e. calibration is a comparison of the device under test against a traceable reference instrument (calibrator) and documenting the comparison. 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. it is not a reference standard and therefore cannot be used for metrological calibration. or alternatively two separate singlefunction calibrators. a device or software able to read and interpret the digital protocol is needed. But how can a smart transmitter. analog transmitter. by definition a traceable reference standard (calibrator) is always needed. However. Calibration of a smart transmitter According to international standards. to see what the transmitter output is. In this case calibration is quite easy and straight forward. therefore. Wired HART (as opposed to WirelessHART) is a hybrid protocol that includes digital communication superimposed on a conventional analog 4–20mA output signal. with output being a digital protocol signal. several types of devices may be needed and several people to do the job. or to read the digital output signal (if it is used). a HART communicator is needed.
Foundation Fieldbus H1 and Profibus PA protocols. energy. Foundation Fieldbus and Profibus PA instruments. a separate communicator is needed in any case. temperature and various electrical signals. calibrator. It has a large 5. The MC6 also contains a full fieldbus communicator for HART. the smart transmitter’s input can be generated/ measured at the same time as reading the digital output. In practice. The MC6 supports all of the protocol commands according to the transmitter’s device description file. oil and gas. including power supply and required impedances for the protocols. There are some other “smart” process calibrators on the market with limited support for different protocols. The results can be automatically stored into the memory of the MC6 or uploaded to calibration software. All required electronics are built-in. About Beamex® MC6 Beamex® MC6 is an advanced. WirelessHART. The usability and ease-of-use are among the main features of the MC6. Any additional communicator is therefore not needed. the smart transmitter’s input can be generated/ measured at the same time as reading the digital output.7" color touch-screen with a multilingual user interface. and you can carry less equipment in the field. 166 . high-accuracy field calibrator and communicator. With the Beamex® MC6. When it comes to configuration of the smart transmitters. ergonomic design and light weight make it an ideal measurement device for field use in various industries. The operation modes are: meter. 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.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. It offers calibration capabilities for pressure. With the Beamex® MC6. The robust IP65-rated dustand water-proof casing. typically only for one protocol (mostly HART) and offering very limited support. service as well as the petrochemical and chemical industries. food and beverage. the MC6 includes a full field communicator for HART. The MC6 is one device with five different operational modes. such as the pharmaceutical. which means that it is fast and easy to use.
A short summary of the main reasons include. In conclusion. safety systems. environmental systems. • Safety reasons. • To achieve high and consistent product quality and to optimize processes. 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”. The MC6 also contains a full fieldbus communicator for HART. • Economical reasons – any measurement having direct economical effect. • Environmental reasons. data logger and Fieldbus communicator. such as quality systems. Foundation Fieldbus and Profibus PA instruments. the MC6 communicates with Beamex® CMX Calibration Software. There are numerous reasons to calibrate instruments initially and periodically. the MC6 is more than a calibrator. the output protocol of a transmitter does not change the fundamental need for calibration. 167 . standards. etc. • Even the best instruments and sensors drift over time.configuring and calibrating smart instruments documenting calibrator. especially when used in demanding process conditions. So why would you calibrate them? First of all. enabling fully automated and paperless calibration and documentation. In addition.employee safety as well as customer/patient safety. • Regulatory requirements.
However. an external flame would not ignite the hydrocarbons. hydrocarbons in mines. retail. certain areas of food plants. Therefore. such as reactors that hydrogenate oils. pharmaceuticals. For example. leaks. in many locations. water/ wastewater. The materials and fluids used in some processes can be hazardous in the sense that they can ignite or explode. 169 . many materials and fluids used in seemingly “safe” industries are themselves flammable. 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. Even seemingly safe water treatment systems use combustible materials such as chlorine in their processes. including agriculture. abnormal conditions. In addition. This means that certain areas of a water treatment plant may well be considered hazardous. oil refineries. such as natural gas. Hydrocarbons and other flammable fluids are not limited to the petroleum and chemical industries. Similarly. If this were truly the case. may pose hazards as well. For example. universities.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. food. and in the home. are used in all industries. pulp/paper. power generation. Improperly calibrating an instrument in this hazardous environment can be almost as dangerous. 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. combustible fuels.
ib Flammable material present intermittently Zone 2 ia. 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). and the protection concept applied. and maintained in accordance with practices that are appropriate for the hazard. 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. ib Flammable material present abnormally In addition. a hot surface temperature on a device can cause ignition. 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. 170 . 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. 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.calibration in hazardous environments selected. In general. frequency of the hazard. installed.
and other variables designed in hazardous locations are generally used to monitor and control the process. but also automatically takes data. The ergonomic design and modular construction allow the user to select the necessary functions in a cost-effective manner. voltage. The Beamex multifunction IS-calibrators are portable and intrinsically safe and have modules that can accommodate wide ranges and many types of pressure. which means that many instruments are calibrated in the field. it is practical to remove these instruments and calibrate them on the workshop with a calibration test bench. level. The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work. This is usually not the case. 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. they can be used for the overwhelming majority of applications where a vapor hazard is present. Fortunately. current. creates documentation. and frequency measurements. pressure. As such.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. Calibration solutions for hazardous locations Instruments designed to measure flow. pulse. In some applications. temperature. RTD. This software generally makes calibration work faster and easier and is designed to integrate into management systems such as SAP and Maximo. thermocouple. there are calibrators that are specifically designed to operate safely in rugged environments and hazardous locations. 171 . It not only alerts you when to calibrate. and tracks calibration history. adheres to GMP regulations (21 CFR 11). The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work.
• Instruments should be specified. and maintained in accordance with requirements for the hazardous location. 172 .calibration in hazardous environments A few points to remember • Improper actions in hazardous locations can result in property damage and bodily injury. installed. • Hazardous locations can exist in virtually all industries. and in the home. Hazardous locations can exist in virtually all industries. and in the home. • Portable Beamex calibrators for hazardous locations are designed to be used in virtually all vapor hazards. stores. operated. stores.
calibration in hazardous environments 173 .
Intrinsically safe calibrators are also often referred to being “Ex calibrators”. By definition.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. a flammable substance and oxygen. and if it occurs it will exist only for a short time. 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. “calibrators for Ex Areas”. intrinsically safe fieldbus calibrators enter into the picture. Intrinsically safe calibrators are designed for potentially explosive environments. 175 . rigs and processing plants. mists. Zone 1: an explosive gas & air mixture is likely to occur in normal operation. 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. but also safely. A hazardous atmosphere is an area that contains elements that may cause an explosion: source of ignition. There are also industrial environments where the calibration of fieldbus instruments should not only be made accurately and efficiently. or “IS calibrators”. The concept has been developed for safely operating process control instrumentation in hazardous areas. Where is intrinsically safe calibration required? Many industries require intrinsically safe calibration equipment. such as gases. An intrinsically safe calibrator is therefore designed to be incapable of causing ignition in the surrounding environment with flammable materials. Zone 2: an explosive gas & air mixture is not likely to occur in normal operation. 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. vapors or combustible dust. such as oil refineries. intrinsic safety (IS) is a protection technique for safely operating electronic equipment in explosive environments.
In addition. Every intrinsically safe calibrator is delivered with a product safety note. First of all. such as the Beamex® MC5.the safest way to calibrate fieldbus instruments pipelines and distribution centres. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. as well as pharmaceutical plants. They can be used for calibration of pressure. the calibrators provide performance and functionality. 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). but in a safe way. temperature and electrical signals. which should be read carefully before using the device. In view of safety. A documenting intrinsically safe calibrator. What are the benefits of using intrinsically safe calibrators? There are clear benefits in using intrinsically safe calibration equipment. it is the safest possible technique. Basically. Safest possible technique Intrinsically safe calibrators are safe for employees. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. 176 . as they can be safely used in environments where the risk of an explosion exists. there are also some guidelines and constraints for how to use them in hazardous areas. This eliminates the need of manual recording of calibration data and improves the quality and productivity of the entire calibration process. petrochemical and chemical plants. 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. Basically. The product safety note lists all the “do’s and don’ts” for safe calibration. provides additional efficiency improvements with its seamless communication with calibration software.IS. Performance and functionality Multifunctional intrinsically safe calibrators provide the functionality and performance of regular industrial calibration devices. Secondly.
ATEX 95 equipment directive 94/9/EC concerns equipment intended for use in potentially explosive areas. it must be done in a non-Ex area. Many times intrinsically safe equipment operate only with dry batteries. 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. maximum is lower). The surface of the device is made of conductive material. IEC (International Electrotechnical Commission) is a nonprofit international standards organization that prepares and publishes international standards for electrical technologies. The battery of an intrinsically safe calibrator is usually slower to charge and it discharges quicker. There are also usually small differences with electrical ranges compared to regular industrial calibrators (e. quicker to discharge • Battery must be charged in a non-Ex area • When using external pressure modules. they must be IS-versions What are ATEX and IECEx? ATEX (“ATmosphères EXplosibles”.g. External pressure modules can be used with IS-calibrators. The objective of the IECEx Scheme is to facilitate international trade in equipment and services for use in explosive atmospheres. IECEx is an international scheme for certifying procedures for equipment designed for use in explosive atmospheres. but they must also be intrinsically safe. maximum is lower) • Battery slower to charge. . 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. The IEC TC/31 technical committee deals with the standards related to equipment for explosive atmospheres. 2003. but the Beamex intrinsically safe calibrators operate with chargeable batteries. 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.g. In addition. 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. Companies in the EU where the risk of explosion is evident must also use the ATEX guidelines for protecting the employees. while maintaining the required level of safety. explosive atmospheres in French) is a standard set in the European Union for explosion protection in the industry.
Safe fieldbus calibration with the Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator The Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is a high accuracy. The MC5-IS can also be used for calibrating Foundation Fieldbus H1 or Profibus PA transmitters. temperature. It is a documenting calibrator. the MC5-IS replaces many individual measurement devices and calibrators. The best way to do this is to send it to the manufacturer or to an authorized service company for repair. electrical and frequency signals. 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. which means that it communicates seamlessly with calibration software.the safest way to calibrate fieldbus instruments As Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is certified according to ATEX and the IECEx Scheme. The MC5-IS is also ATEX and IECEx certified. Recalibration can be done by calibration laboratories (still preferably with ISO/IEC 17025 accreditation). The MC5-IS also has HART communication. The MC5-IS also has HART communication. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. all-in-one calibrator for extreme environments. Being an all-in-one calibrator. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. 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. Using documenting calibrators with calibration software can remarkably improve the efficiency and quality of the entire calibration process. 178 .
its definition from a common grammar dictionary should never be used in work where the technical standard can apply. journals. Jay L. It is a supplement to the VIM. as well as publications of relevant technical and professional organizations. 181 . If a word is defined in a technical standard. NCSL Glossary. Many of these definitions are adapted from the references. so everyone in the business knows what it is. GUM. However.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. Milwaukee: ASQ Quality Press. international and industry standards. Those documents give the intended meaning of the word. ______________ 1. In technical. Bucher. only the technical definitions should be used. scientific and engineering work (such as metrology) it is important to correctly use words that have a technical meaning. and other publications. The Metrology Handbook. and the information in the other references listed at the end. In some cases several may be merged to better clarify the meaning or adapt the wording to common metrology usage. The technical definitions may be different from the definitions published in common grammar dictionaries. Definitions of these words are in relevant national. not to standardize the way the words should be used. the purpose of common dictionaries is to record the ways that people actually use words. 2004. In technical work.
U. 1997. 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. Boulder. 2. Geneva: ISO. IUPAC. (It is assumed that a calibration or metrology activity owns copies of these as part of its basic reference material. BIPM. serves as proof of accredited status for the time period listed. Accreditation body – An organization that conducts laboratory accreditation evaluations in conformance to ISO Guide 58. CO: NCSL International. 3. Accreditation certificate – Document issued by an accreditation body to a laboratory that has met the conditions and criteria for accreditation. 2nd ed. S. IEC. 3. An accreditation certificate without the documented parameters is incomplete. NCSL Glossary of metrology-related terms. IUPAP. Accreditation criteria – Set of requirements used by an accrediting body that a laboratory must meet in order to be accredited. accuracy of a measurement is always 182 . with the documented measurement parameters and their best uncertainties. The certificate. ANSI/NCSL. ISO.appendix: calibration terminology a to z 1 Terms that are not in this glossary may be found in one of these primary references: 1. 1999.5) Because the true value is always unknown. but should be considered an addition to the references listed above. ANSI/NCSL Z540-2-1997. Boulder. NCSL. International vocabulary of basic and general terms in metrology (called the VIM). CO: NCSL International. Accreditation includes evaluation of both the quality management system and the competence to perform the measurements listed in the scope. 1993. not a replacement of them. and OIML. Some terms may be listed in this glossary in order to expand on the definition. IFCC. Guide to the expression of uncertainty in measurement (called the GUM). (VIM. ISO.) 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.
which is always the negative of the bias.11 and NCSL pages 4–5 for primary and secondary definitions. 5. Bias – Bias is the known systematic error of a measuring instrument. or reproduce a unit of that quantity or one or more of its values. 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. or when performing more-or-less routine calibrations of nearly ideal measuring instruments designed for the measurement of that quantity. 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. It has quantitative value only when accompanied by information about the uncertainty of the measuring system.” (EA-4/02) The best measurement capability is based on evaluations of actual measurements using generally accepted methods of evaluating measurement uncertainty. 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.25) The value and direction of the bias is determined by calibration and/or gage R&R studies.18) Accuracy is a design specification and may be verified during calibration. (See VIM 6. conserve. Adding a correction. compensates for the bias. realize. Bespoke/Customized computerised system – A computerised system individually designed to suit a specific business process Best measurement capability – For an accredited laboratory. An accuracy statement by itself has no meaning other than as an indicator of quality. systematic error Calibration – (1). (VIM.appendix: calibration terminology a to z 1 an estimate. Calibration is performed with the item being calibrated in 183 . 5. It is the process of verifying the capability and performance of an item of measuring and test equipment by comparison to traceable measurement standards.) Calibration is a term that has many different – but similar – definitions. (VIM.
and with a specified and controlled measurement system. The result of a calibration is a determination of the performance quality of the instrument with respect to the desired specifications. but of unverified accuracy. if necessary. or lamps. fuses. This may be in the form of a pass/fail decision. • Calibration does not include any maintenance or repair actions except as just noted. to a measurement system or device of specified capability and known uncertainty in order to detect. under a set of specified and controlled measurement conditions. minor repair such as replacement of batteries. or artifacts as needed to verify the performance. See also: performance test. • In some cases.appendix: calibration terminology a to z 1 its normal operating configuration – as the normal operator would use it. 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. report. determining or assigning one or more values. The calibration process uses traceable external stimuli. 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. Notes: • A requirement for calibration does not imply that the item being calibrated can or should be adjusted. The calibration process consists of comparing an IM&TE unit with specified tolerances. or minor adjustment such as zero and span. or minimize by adjustment any deviations from the tolerance limits or any other variation in the accuracy of the instrument being compared. or the determination of one or more corrections. calculation of correction factors or adjustment of the instrument being compared to reduce the magnitude of the inaccuracy. measurement standards. or is otherwise in an indeterminate state. may be included as part of the calibration. 184 . Calibration provides assurance that the instrument is capable of making measurements to its performance specification when it is correctly used. • The calibration process may include. Calibration is performed according to a specified documented calibration procedure.
the intent is that they are part of the normal work done by a trained user of the system. including subsidiary operations of a larger entity. specifications. or department. When used this way. or tolerances for a model of measuring or testing equipment. a means to record 185 . shop. if it is amended later a new certificate is created. Examples include performing a selftest as part of normal operation or performing a self-calibration (normalizing) a measurement system before use. A laboratory database certificate is a record that cannot be changed. self-calibration.appendix: calibration terminology a to z 1 is known to be out of tolerance. which are repair activities and excluded from the metrological definition of calibration. or any combination or variation of these. a metrology laboratory or department. When calibration is used to refer to tasks like this. or after it is repaired. Calibration certificate – (1) A calibration certificate is generally a document that states that a specific item was calibrated by an organization. calibration means the same as alignment or adjustment. These and similar tasks are excluded from the metrological definition of calibration. the organization presenting the certificate. A calibration procedure documents one method of verifying the actual performance of the item being calibrated against its performance specifications. or an industry-specific name. a certificate often refers to the permanent record of the final result of a calibration. It provides a list of recommended calibration standards to use for the calibration. The certificate identifies the item calibrated. IM&TE instruction manuals may use calibration to describe tasks normally performed by the operator of a measurement system. (2) In a laboratory database program. It may be external or internal. Contrast with: calibration (1) See also: normalization. It may be called a calibration laboratory. and the effective date. A calibration certificate should provide other information to allow the user to judge the adequacy and quality of the calibration. (B) In many cases. standardization Calibration activity or provider – A laboratory or facility – including personnel – that perform calibrations in an established location or at customer location(s). 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.
See also: calibration certificate Calibration seal – A calibration seal is a device. and by virtue of its design and material.14. Calibration standard – (See VIM. Calibration program – A calibration program is a process of the quality management system that includes management of the use and control of calibrated inspection. Note: A calibration seal may also be referred to as a tamper seal. and 6.13. they are more closely controlled and characterized than the workload items they are used for. As calibration standards are used to calibrate other IM&TE items. In addition to the basic items of a calibration certificate. 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. or measurement transfer standard that is designated as being used only to perform calibrations of other IM&TE items. a calibration report includes details of the methods and standards used.) A calibration standard is an IM&TE item. or label that. when removed or tampered with. and test and measuring equipment (IM&TE). 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. and the process of calibrating IM&TE used to determine conformance to requirements or used in supporting activities. the parameters checked. artifact.1 through 6. Designation as a 186 . A calibration program may also be called a measurement management system (ISO 10012:2003). standard reference material.appendix: calibration terminology a to z 1 quantitative performance data both before and after adjustments.9. and NCSL pages 36–38. Note: A calibration procedure does not include any maintenance or repair actions. 6. and the actual measurement results and uncertainty. Calibration standards generally have lower uncertainty and better resolution than general-purpose items.” 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. The purpose of a calibration seal is to ensure the integrity of the calibration. clearly indicates tampering. Calibration report – A calibration report is a document that provides details of the calibration of an item. and information sufficient to determine if the unit being calibrated is operating within the necessary performance specifications. 6. placard.
whose fitness for use is demonstrated by a broad spectrum of users. (GUM. and so on. the confidence interval is: p (1 – p) s CI = x ¯ ± t = ––– or CI = p ± ––––––––– n n where CI is the confidence interval. n is the number of items in the sample. in a group of identical instruments. For a person. Competence – For a laboratory. the demonstrated ability to apply knowledge and skills. For example. since it is a synonym and has more accepted usage in the United States. Confidence intervals can be calculated for points. when that result is obtained from the values of a number of other quantities. weighted according to how the measurement result varies with changes in those quantities. s is the sample standard deviation.3. 187 . It is equal to the positive square root of a sum of terms.appendix: calibration terminology a to z 1 calibration standard is based on the use of the specific instrument.4) See also: expanded uncertainty Commercial of the shelf software – Software commercially available. lines. however. x is the sample mean. standard deviations. For an infinite (or very large compared to the sample) population. not on any other consideration. slopes. Calibration standards are often called measurement standards. The confidence interval is calculated from sample statistics. 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. one might be designated as a calibration standard while the others are all general purpose IM&TE items. and t is the Student’s T value for α ⁄2 and (n – 1) (α is the level of significance). See also: standard (measurement) Combined standard uncertainty – The standard uncertainty of the result of a measurement. The terms are the variances or covariances of these other quantities. p is the proportion of items of a given type in the population. 2. Note: The word qualification is sometimes used in the personal sense. the demonstrated ability to perform the tests or calibrations within the accreditation scope and to meet other criteria established by the accreditation body.
See also: bias. The exact meaning can usually be determined from examination of the calibration certificate.6) The coverage factor is identified by the symbol k. sometimes referred to as a nonconformance. Systematic error (also known as bias) may be corrected. which 188 .10. correction (of error). systematic error Gage R&R – Gage repeatability and reproducibility study. documented determination that a specific instrument or type of instrument is suitable for use in place of the one originally listed. 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. Deficiency – Nonfulfillment of conditions and/or criteria for accreditation. (VIM. and/or accredited organizations within the host country. error. It is usually given the value 2. accreditation body. it is always an estimate. 3. 3.3.14. Error (of measurement) – (See VIM. 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. which approximately corresponds to a probability of 95 percent for degrees of freedom > 10’. error or systematic error. random error. See also: bias.15) Any residual amount is treated as random error. The correction value is equal to the negative of the bias. including actions taken to prevent reoccurrence of the nonconformance. Departure value – A term used by a few calibration laboratories to refer to bias. 3. (GUM. and NCSL pages 11–13. 2. 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. systematic error Corrective action – Corrective action is something done to correct a nonconformance when it arises.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. for a particular application. Error may be systematic and/or random. and/or accredited organizations in other countries as being essentially equal to the NMI. random error.12–3. (B) A formal. accreditation bodies. Equivalence – (A) Acceptance of the competence of other national metrology institutes (NMI). The error can never be known exactly.) In metrology.
the equivalent document is ANSI/NCSL Z540-2-1997. which is expressed as an uncertainty with a coverage factor of k = 2 to approximate 95 percent. personnel. An internal audit is done by or on behalf of the laboratory itself. and so on) where a tolerance is not specified and the indication is not critical to safety. with headquarters in Geneva. Note: Organizations may refer to IM&TE items as MTE (measuring and testing equipment). PME (precision measuring equipment). PMET (precision measuring equipment and tooling). measuring. and diagnostic equipment). measuring. or after a process. The mission of ISO is “to promote the development of standardization and 189 . TMDE (test. during. This term includes all items that fall under a calibration or measurement management program. IM&TE items are typically used in applications where the measurement results are used to determine conformance to technical or quality requirements before. and measurements over a period of time to capture quantitative observations. GUM – An acronym commonly used to identify the ISO Guide to the Expression of Uncertainty in Measurement. measurements. performance. 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. In the United States. pressure. and test equipment. Interlaboratory comparison – Organization. so it is a first-party audit. Some organizations do not include instruments used solely to check for the presence or absence of a condition (such as voltage.appendix: calibration terminology a to z 1 (typically) employs numerous instruments. IM&TE – The acronym IM&TE refers to inspection. or SPETE (special purpose electronic test equipment). S. and length of time are established to be statistically valid consistent with the size and level of activity of the organization. GPETE (general purpose electronic test equipment). Guide to the Expression of Uncertainty in Measurement. The number of instruments. and evaluation of tests or calibrations on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions. Switzerland. International Organization for Standardization (ISO) – An international nongovernmental organization chartered by the United Nations in 1947. The data captured are analyzed statistically to obtain best measurement capability. U. personnel.
Management review – The planned.) See also: ISO International System of Units (SI) – A defined and coherent system of units adopted and used by international treaties. length. (Mass. so it will be a constant in all languages.) SI units are defined and maintained by the International Bureau of Weights and Measures (BIPM) in Paris. it would be different in each language. the coverage level expressed as a percent. 2.) The name also symbolizes the mission of the organization – to equalize standards worldwide. installation.1) 190 . ISO – Iso is a Greek word root meaning equal. The SI system is popularly known as the metric system. Effectively. specification. amount of substance. operation. IT Infrastructure – The hardware and software such as networking software and operation systems.appendix: calibration terminology a to z 1 related activities in the world with a view to facilitating the international exchange of goods and services. Measurement – A set of operations performed for the purpose of determining the value of a quantity. (The acronym SI is from the French Systéme International. In this context. and luminous intensity. which makes it possible for the application to function. time. (If the acronym was based on the full name were used. and maintenance. testing. 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. scientific. 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. industry and commerce except electrical and electronic engineering. Life cycle – All phases in the life of the system from initial requirements until retirement including design. (VIM. France. programming. technological and economic activity. periodic. and to developing cooperation in the spheres of intellectual. The members of ISO are the designated national standards bodies of each country. (The United States is represented by ANSI. electric current.) SI is international system of measurement for all physical quantities.” The scope of ISO’s work covers all fields of business. ISO is not an acronym. formal. The International Organization for Standardization chose the word as the short form of the name. and p is the coverage probability or level of confidence of the interval. thermodynamic temperature.
the quantum charge ratio (h/e). The measurement system includes at least the test and measuring instruments and devices. 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. or the use of a virtual office. the personnel. Natural constants are used in the basic theoretical descriptions of the universe. Natural (physical) constant – A natural constant is a fundamental value that is accepted by the scientific community as valid. the gravitational constant (G). NCSL promotes technical and managerial excellence in the field of metrology. then the theoretical thermoelectric emf measured at the copper wires should be zero. Metrolog y – Metrology is the science and practice of measurement (VIM. scientific. the ratio of a circle’s circumference to its diameter (p). and the physical environment. associated materials and accessories. measurement standards. whose membership is open to any organization with an interest in the science of measurement and its application in research.” Normalization. people. Any value other than zero is an offset created by inhomogeneity of the thermocouple wires combined 191 . the procedures used.appendix: calibration terminology a to z 1 Measurement system – A measurement system is the set of equipment. For example. industrial. education. home. instrument calibration.16 K). development. 2. Mobile operations may include work from an office space. NCSL was formed in 1961 to “promote cooperative efforts for solving the common problems faced by measurement laboratories. the triple point of water (273. commercial and government facilities around the world. and other quantifiable factors that combine to determine the success of a measurement process. and the base of natural logarithms (e). if the thermocouple alloy leads of a reference junction probe are formed into a measurement junction and placed in an ice point cell. methods. vehicle. or commerce. conditions. NCSL international – Formerly known as the National Conference of Standards Laboratories (NCSL). and test and measurement. NCSL is a nonprofit organization. Mobile operations – Operations that are independent of an established calibration laboratory facility. Examples of natural physical constants important in metrology are the speed of light in a vacuum (c). and the reference junction itself is also in the ice point. NCSL has member organizations from academic.2).
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. Some policies may be implemented by fairly detailed procedures. This includes climate-controlled mobile laboratories. Compare with: bias. A performance test is the same as a calibration (1).appendix: calibration terminology a to z 1 with other uncertainties. Calibration: see calibration procedure. goals. See also: policy Process owner – The person responsible for the business process. page 26) Precision is not the same as accuracy. (NCSL. 3. 192 . See also: procedure Precision – Precision is a property of a measuring system or instrument. See also: calibration (1) Policy – A policy defines and sets out the basic objectives. A procedure has more detail than a policy but less detail than a work instruction. Policies can also be in the organization’s policy/procedure manual. (VIM. Contrast with: corrective action Procedure – A procedure describes a specific process for implementing all or a portion of a policy. A policy describes what management intends to have done regarding a given portion of business activity. even though such an event has not yet happened. but actually perform the calibration actions at customer locations. There may be more than one procedure for a given policy. Preventive action helps improve the system. vision. A performance test is done with the item in its normal operating configuration. error On-site operations – Operations that are based in or directly supported by an established calibration laboratory facility.5) Preventive action – Preventive action is something done to prevent the possible future occurrence of a nonconformance. or general management position on a specific topic. while others may only have a few general guidelines. Policy statements relevant to the quality management system are generally stated in the quality manual. 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. 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.
work instructions.) The need for repair may be indicated by the results of a calibration. Passing 193 . The quality manual is generally provided to customers on request. or minor cleaning of switch contacts. it does not usually contain any detailed policies and never contains any procedures. Note: Contrary to popular belief. 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. therefore. Random error is usually evaluated by Type A methods. 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. (Some minor adjustment such as zero and span may be included as part of the calibration. repair is always followed by calibration of the item. or has covers removed. auditors use the quality manual when they audit the quality management system. or repairing a broken wire. (VIM. For calibratable items. or lamps. minor repair is always followed by calibration of the item. See also: error Compare with: systematic error Repair – Repair is the process of returning an unserviceable or nonconforming item to serviceable condition. In addition to its regular use by the organization. or replacing one or two in-stock components. Examples include replacement of batteries. or proprietary information. Repair includes adjustment or alignment of the item as well as component-level repair. Contrast with: calibration (1). is a measure of dispersion. Quality manual – The quality manual is the document that describes the quality management policy of an organization with respect to a specified conformance standard. For calibratable items. 3. or is removed from its case and may be disassembled to some degree. Therefore. Random error – Random error is the result of a single measurement of a value. minus the mean of a large number of measurements of the same value. fuses. 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.13) Random error causes scatter in the results of a sequence of readings and. The need for repair may be indicated by the results of a calibration. the GUM specifically does not replace random error with either Type A or Type B methods of evaluation. Passing the calibration test indicates success of the repair. The instrument is opened.
The scope document is an attachment to the certificate of accreditation and the certificate is incomplete without it. day. 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. • Deviation from the nominal (or reference) value and uncertainty. The process may be required at intervals such as every power-on sequence.appendix: calibration terminology a to z 1 the calibration test indicates success of the repair. Round robin – See: Interlaboratory Comparison Scope of accreditation – For an accredited calibration or testing laboratory. parameters. The specific type and format vary according to the type of measurement being made. the scope is a documented list of calibration or testing fields. and where no parts have to be ordered from external suppliers. with the associated measurement uncertainty. The reported value is usually the mean of a number of repeat measurements. or once per shift. • Estimated systematic error and uncertainty. or week of continuous operation. In general. or calibrations and their best measurement. repair Reported value – One or more numerical results of a calibration process. The accreditation body usually defines the format and other details. 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 the difference between the nominal value and the mean of a number of repeat measurements. or if the ambient temperature changes by a specified 194 . Only the calibration or testing areas that the laboratory is accredited for are listed in the scope document. most reported values will be in one of these formats: • Measurement result and uncertainty. as recorded on a calibration report or certificate. and only the listed areas may be offered as accredited calibrations or tests. The uncertainty of the deviation is usually expanded uncertainty as defined in the GUM. Minor repairs are defined as repairs that take no longer than a short time as defined by laboratory management. and where substantial disassembly of the instrument is not required. The uncertainty is usually expanded uncertainty as defined in the GUM. Contrast with: calibration (1). uncertainty. specific measurements.
Customers use specifications to determine the suitability of a product for their own applications. given in terms of the relevant parameters and including the accuracy or uncertainty. instrument. device. Standard (measurement) – A standard (measurement standard. a specification is a documented statement of the expected performance capabilities of a large group of substantially identical measuring instruments.appendix: calibration terminology a to z 1 amount. The usual purpose is accuracy enhancement by characterization of errors inherent in the measurement system before the item to be measured is connected. 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. or international standard. reference standard. or scrapping.B) Contrast with: calibration (1) Specification – In metrology. Accepted as having the highest metrological 195 . 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. calibration standard. or the methods for evaluation of any of these. An example is ANSI/NCSL Z540-11994. Compare with: calibration (2. if an instrument requires self-calibration before use. national. Also. A product that performs outside the specification limits when tested (calibrated) is rejected for later adjustment. Standard (document) – A standard (industry. 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. artifact. 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. or material that is used as a defined basis for making quantitative measurements. then that will also be accomplished at the start of a calibration procedure. Selfcalibration may also be called normalization or standardization. Once initiated. an étalon) is a system. Items with similar uses in a production shop are generally regarded as working-level instruments by the calibration program. Measurement standards are generally used in calibration laboratories. laboratory standard. the process may be performed totally by the instrument or may require user intervention and/or use of external calibrated artifacts. repair. government. Primary standard.
procedures. (3. SRMs represent one of the primary vehicles for disseminating measurement technology to industry. 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. expressed as a standard deviation.appendix: calibration terminology a to z 1 qualities and whose value is accepted without reference to other standards of the same quantity.1) Standardization – See: self-calibration.3. and is accompanied by. Also called a reference standard. Examples: triple point of water cell and caesium beam frequency standard. found in national and international metrology laboratories. Systematic error is a measure of magnitude and may be corrected. The highest level standards. (VIM. (GUM. 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. A device used to transfer the value of a measurement quantity (including the associated uncertainty) from a higher level to a lower level standard. 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.3. Note: Contrary to popular belief. Working standard. A standard that is used for routine calibration of IM&TE. Systematic error is also called bias when it applies to a measuring instrument. are the realizations or representations of SI units. according to the type of data available.” Standard uncertainty – The uncertainty of the result of a measurement. Secondary standard. Systematic error may be evaluated by Type A or Type B methods. or traceable to. error.14) Systematic error causes the average of the readings to be offset from the true value. 2. note) See also: bias. The highest accuracy level standards in a particular laboratory generally used only to calibrate working standards. 3. Transfer standard.2. See also: calibration standard Standard operating procedure (SOP) – A term used by some organizations to identify policies. or work instructions. the GUM specifically does not replace systematic error with either Type A or Type B methods of evaluation. correction (of error) Compare with: random error 196 .
(2) In the normal use of IM&TE items. it represents the maximum allowable deviation from a specified value. Test accuracy ratio – (1) In a calibration procedure. 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. they must be converted to absolute values of the basic measurement units. or another ratio. Note: TAR may also be referred to as the accuracy ratio or (incorrectly) the uncertainty ratio. A tolerance is a property of the item being measured. 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. they must be converted to absolute values of the basic measurement units. percentage.appendix: calibration terminology a to z 1 System owner – The person responsible for the availability. 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. the TAR is the ratio of the tolerance of the parameter being measured to the accuracy tolerance of the IM&TE. uncertainty 197 . and maintenance of a computerised system and for the security of the data residing on that system. (NCSL. If the accuracy tolerances are expressed as decibels. page 2) TUR = UUT_tolerance STD_uncert The TUR must be calculated using identical parameters and units for the UUC and the calibration standard. Tolerances are applied during design and manufacturing. percentage. Compare with: specification. Test uncertainty ratio – In a calibration procedure. Note: The uncertainty of a measurement standard is not necessarily the same as its accuracy specification. If the accuracy tolerances are expressed as decibels. page 2) TAR = UUT_tolerance STD_tolerance The TAR must be calculated using identical parameters and units for the UUC and the calibration standard.
or any other thing is not and be traceable to a national standard. providing the ability to relate the measurement result to stated references. a calibrated IM&TE. capacitors. 6. (NCSL.appendix: calibration terminology a to z 1 Traceable. provided all of the conditions just listed are met. Traceability provides the ability to demonstrate the accuracy of a measurement result in terms of the stated reference. 198 . Evidence of traceability includes the calibration report (with values and uncertainty) of calibration standards. A calibration system operating under a program controls system only implies traceability. and singlevalue standard resistors. Measurement assurance methods applied to a calibration system include demonstration of traceability. (VIM. a calibration report. (VIM. but the report alone is not sufficient. The laboratory must also apply and use the data.8) Typical applications of transfer standards are to transfer a measurement parameter from one organization to another. Examples of typical transfer standards are DC volt sources (standard cells or zener sources). or industry or other accepted consensus reference standards. ratio type comparisons. through an unbroken chain of comparisons each having stated uncertainties. from a primary standard to a secondary standard. or from a secondary standard to a working standard in order to create or maintain measurement traceability. a measurement system. traceability – Traceability is a property of the result of a measurement. pages 42–43) The stated references are normally the base or supplemental SI units as maintained by a national metrology institute. Only the result of a specific measurement can be said to be traceable. certified standard reference materials.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. or inductors. Transfer standard – A transfer standard is a measurement standard used as an intermediate device when comparing two other standards. 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. Reference to a NIST test number is specifically not evidence of traceability. 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. Common transfer methods are differential measurements and ratio measurements. 6. A calibration laboratory. fundamental or physical natural constants that are reproducible and have defined values.
(GUM.3.3) Uncertainty is an estimate of the range of values that the true value of the measurement is within.3 through 3. These are standard generic labels for the IM&TE item that is being calibrated.5) Data for evaluation by Type B methods may come from any source believed to be valid. VIM – An acronym commonly used to identify the ISO International 199 . and/ or other applicable measurement criteria. effects that contribute to the dispersion may be random or systematic.5) Uncertainty can only be evaluated by Type A methods if the laboratory actually collects the data. with a specified level of confidence. Verification – Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. After an item that has a specified tolerance has been calibrated using an instrument with a known accuracy. and/or procedures are fit for their intended use. UUT – The unit under calibration or the unit under test – the instrument being calibrated. (GUM. the result is a value with a calculated uncertainty.3.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. which are used in the text of the calibration procedure for convenience. Uncertainty is an estimate of dispersion. range of measurement. Uncertainty – Uncertainty is a property of a measurement result that defines the range of probable values of the measurand. categorized by type of measurement. 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. Both random and systematic error may be evaluated by Type B methods. 3. Also may be called device under test (DUT) or equipment under test (EUT). See also: Type A evaluation. UUC.3.3. Type B evaluation Uncertainty budget – The systematic description of known uncertainties relevant to specific measurements or types of measurements. 2.3 through 3. 3. methods. (GUM.2. Validation – Substantiation by examination and provision of objective evidence that verified processes. Type B evaluation (of uncertainty) – Type B evaluation of measurement uncertainty includes any method except statistical analysis of actual measurement results. Both random and systematic error may be evaluated by Type A methods.
Jay L. a work instruction defines the detailed steps necessary to carry out a procedure. In a metrology laboratory. (The acronym comes from the French title. 2004. Milwaukee: ASQ Quality Press. 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. 1. 200 . Bucher. a calibration procedure is a type of work instruction.) Work Instruction – In a quality management system. The Metrology Handbook.appendix: calibration terminology a to z 1 Vocabulary of Basic and General Terms in Metrology. Work instructions are used only where they are needed to ensure the quality of the product or service.
PORTABLE CALIBRATORS WORKSTATIONS PROFESSIONAL SERVICES CALIBRATION SOFTWARE 202 .
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