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Ultimate Calibration 2nd Edition
Beamex is a technology and service company that develops, manufactures and markets high-quality calibration equipment, software, systems and services for the calibration and maintenance of process instruments. The company is a leading worldwide provider of integrated calibration solutions that meet even the most demanding requirements. Beamex offers a comprehensive range of products and services-from portable calibrators to workstations, calibration accessories, calibration software, industry-specific solutions and professional services. Through Beamex’s global and competent partner network, their products and services are available in more than 60 countries. As a proof of Beamex’s success, there are more than 10,000 companies worldwide utilizing their calibration solutions. Several companies have been Beamex’s customer since the establishment of the company over 30 years ago. For more information about Beamex and its products and services, visit www.beamex.com
Beamex has used reasonable efforts to ensure that this book contains both accurate and comprehensive information. Notwithstanding the foregoing, the content of this book is provided “as is” without any representations, warranties or guarantees of any kind, whether express or implied, in relation to the accuracy, completeness, adequacy, currency, quality, timeliness or fitness for a particular purpose of the content and information provided on this book. The contents of this book are for general informational purposes only. Furthermore, this book provides examples of some of the laws, regulations and standards related to calibration and is not intended to be definitive. It is the responsibility of a company to determine which laws, regulations and standards apply in specific circumstances.
Ultimate Calibration 2nd Edition Copyright © 2009–2012 by Beamex Oy Ab. All rights reserved. No part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without the prior written permission of Beamex Oy Ab. Requests should be directed to firstname.lastname@example.org. Beamex is a trademark of Beamex Oy Ab. All other trademarks or trade names mentioned in this book are the property of their respective holders.
Graphic design: Studio PAP Photos: Mats Sandström and image bank Printed by: Fram in Vaasa 2012, Finland
Contents Preface by the CEO of Beamex Group 7 QUALITY. REGULATIONS AND TRACEABILITY Quality standards and industry regulations 11 A basic quality calibration program 35 Traceable and efficient calibrations in the process industry 57 CALIBRATION MANAGEMENT AND MAINTENANCE Why Calibrate? What is the risk of not calibrating? 73 Why use software for calibration management? 79 How often should instruments be calibrated? 89 How often should calibrators be calibrated? 97 Paperless calibration improves quality and cuts costs 101 Intelligent commissioning 107 Successfully executing a system integration project 115 CALIBRATION IN INDUSTRIAL APPLICATIONS The benefits of using a documenting calibrator 125 Calibration of weighing instruments Part 1 131 Calibration of weighing instruments Part 2 137 Calibrating temperature instruments 143 Calculating total uncertainty of temperature calibration with a dry block 149 Fieldbus transmitters must also be calibrated 157 Configuring and calibrating smart instruments 163 Calibration in hazardous environments 169 The safest way to calibrate to calibrate Fieldbus instruments 175 APPENDIX: Calibration terminology A to Z 181 .
foreword 6 .
The new topics covered in the edition mainly discuss paperless calibration. calibration procedures need to be automated to a higher degree and integrated to achieve improvements in quality and efficiency. beamex group 7 . A team of experts in industry and calibration worldwide has put forth effort to its creation. Just like any other business function. and how to lower the risk of human errors. how to reduce production down-time. On behalf of Beamex. I hope this book will assist you in learning new things and in providing fresh. Calibration and calibrators can no longer be considered as isolated. how to eliminate double work.preface by the ceo of beamex group Preface C alibrators. stand-alone devices. temperature calibration and configuring. Enjoy your reading! raimo ahola. intelligent commissioning. who was the key person in organizing and leading the project for the 2nd edition. In this area. 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. I want to express my special thanks to Pamela at Beamex Marketing. This book is the 2nd edition of Ultimate Calibration. Beamex aims to be the benchmark in the industry. systems or work processes within a company or production plant. ceo. new ideas. the primary challenges of industrial metrology and calibration include how to simplify and streamline the entire calibration process. I would like to thank all of the people who have contributed to this book. All of these challenges can be tackled by improving the level of system integration and automation. Presently. and calibration of smart instruments. This book is the result of work that has taken place between 2006 and 2012. 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.
Regulations and Traceability .Quality.
beer. but when you cannot express it in numbers.. thus confused by false appearance. the Egyptian unit of length came into being. The Republic. in your thoughts. The Egyptians studied the science of geometry to assist them in the construction of the Pyramids. (Plato. A. and the clerk of the scales. Surely it is the better part of thought that relies on measurement and calculation. and there shall be standard weights also. advanced to the stage of science. numbering and weighing. GCVO. and a standard width of dyed russet and cloth. 1st Baron Kelvin.K. but reason. the computer. (Clause 35. It is believed that about 3000 years B. OM. 26 June 1824–17 December 1907.A.) There shall be standard measures of wine. 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 . you know something about it. here is a reminder from times past about measurement practices and how important they really are. 360 B. PRS. Lord Kelvin).1 One of the earliest records of precise measurement is from Egypt. It may be the beginning of knowledge.C. Magna Carta. PC. these drive vague notions of greater or less or more or heavier right out of the minds of the surveyor. your knowledge is of a meager and unsatisfactory kind. (William Thomson. 1215) When you can measure what you are speaking about and express it in numbers.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. is beautifully restored by measuring. and corn… throughout the whole of our kingdom. but you have scarcely.C. Immersion in water makes the straight seem bent.
if a company is manufacturing a drug that must meet regulatory requirements. The biggest difference between the two is simple – ISO standards are voluntary. they pay a company to audit them to that standard to ensure they are following their quality manual and are within compliance. Failure to do so was punishable by death.5 inches or 11. They were required to bring back their cubit sticks at each full moon to be compared to the Royal Cubit Master. In Europe.36276 meters. However. Thousands of workers were engaged in building the Great Pyramid of Giza. the Egyptians had anticipated the spirit of the present day system of legal metrology. With this standardization and uniformity of length. traceability and calibration recall. Workers engaged in building tombs. they achieved an accuracy of 0. detailed information for achieving regulatory compliance is provided in Eudralex . etc. the Egyptians achieved surprising accuracy. 12 . 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. Through the use of cubit sticks. If an organization volunteers to meet ISO 9000 standards. 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). they were within 4. The need for calibration has been around for at least 5000 years.Volume 4 of “The rules governing medicinal products in the European Union”. were supplied with cubits made of wood or granite. standards. there are basically two types of requirements: ISO standards and regulatory requirements. In the case of ISO standards. 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.05%. In roughly 756 feet or 230. In today’s calibration environment.2 The “Royal Cubit Master” was carved out of a block of granite to endure for all times. On the other hand. and regulatory requirements are mandatory. The Royal Architect or Foreman of the construction site was responsible for maintaining & transferring the unit of length to workers instruments.43 centimeters.quality standards and industry regulations finger plus the width of the palm of the hand of the Pharaoh or King ruling at that time. temples. pyramids. Though the punishment prescribed was severe. they are inspected by government inspectors for compliance to federal regulations.
Please note that European standards are similar to FDA requirements. § 820. § 820.25 – Personnel.50 – Purchasing controls.30 – Design controls.65 – Traceability. § 820. Subpart E – Purchasing Controls § 820. and test equipment. that relate to the calibration of test equipment in different situations and environments. Subpart B – Quality System Requirements § 820. § 820.1 – Scope.3 – Definitions.20 – Management responsibility. 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. § 820. Listed below are several different parts of 21CFR. § 820. Subpart C – Design Controls § 820.70 – Production and process controls. § 820. Subpart D – Document Controls § 820. Subpart G – Production and Process Controls § 820. and what they say about calibration and what must be accomplished to meet the CFRs.5 – Quality system. measuring.quality standards and industry regulations Calibration requirements according to the U.60 – Identification.40 – Document controls. Subpart F – Identification and Traceability § 820. S.22 – Quality audit. Food and Drug Administration (FDA) Following are examples of some of the regulations required by the FDA.75 – Process validation. 13 .
Distribution.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. and Installation § 820. § 820.140 – Handling. Subpart N – Servicing § 820.186 – Quality system record. § 820.181 – Device master record. § 820. in-process. Subpart O – Statistical Techniques § 820. Subpart M – Records § 820.100 – Corrective and preventive action.120 – Device labeling.80 – Receiving. § 820.quality standards and industry regulations Subpart H – Acceptance Activities § 820. 2012] [CITE: 21CFR820.130 – Device packaging.198 – Complaint files. § 820. Storage. § 820. § 820.86 – Acceptance status. Volume 8] [Revised as of April 1.170 – Installation. § 820. [Code of Federal Regulations] [Title 21.90 – Nonconforming product.250 – Statistical techniques. Subpart I – Nonconforming Product § 820.180 – General requirements.160 – Distribution.200 – Servicing. § 820. Subpart L – Handling. and finished device acceptance.150 – Storage.184 – Device history record. Subpart J – Corrective and Preventive Action § 820.
measuring. automated. or electronic inspection and test equipment. Calibration procedures shall include specific directions and limits for accuracy and precision. checked. 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. the individual performing each calibration. and the next calibration date shall be documented. If national or international standards are not practical or available. inspected. the manufacturer shall use an independent reproducible standard. so that its accuracy and fitness for use are maintained. Each manufacturer shall ensure that all inspection. These activities shall be documented. preservation. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated. the manufacturer shall establish and maintain an in-house standard. and test equipment. including mechanical.quality standards and industry regulations PART 820–QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls Sec. measuring. and test equipment shall be traceable to national or international standards. The equipment identification. 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. The procedures shall include provisions for handling. 15 . and test equipment.72 Inspection. (1) C alibration standards. These activities shall be documented. is suitable for its intended purposes and is capable of producing valid results. When accuracy and precision limits are not met. calibration dates. and storage of equipment. measuring. (b) Calibration. and test equipment. (a) Control of inspection. Calibration standards used for inspection. 820. measuring. If no applicable standard exists. (2) Calibration records. and maintained.
Laboratory controls shall include: (1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components. closures. drug product containers. and purity. strength. including computers. 211. inspected. or related systems that will perform a function satisfactorily. and electronic equipment. quality. or checked according to a written program designed to assure proper performance. standards. may be used in the manufacture. and test procedures designed to assure that components. and holding of a drug product. 16 . and drug products conform to appropriate standards of identity. drug product containers. mechanical. or electronic equipment or other types of equipment. labeling. (b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications. (a) Automatic.quality standards and industry regulations [Code of Federal Regulations] [Title 21. packing. sampling plans. mechanical.68 Automatic.160 General requirements. Volume 4] [Revised as of April 1. Written records of those calibration checks and inspections shall be maintained. 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. closures. in-process materials. If such equipment is so used. it shall be routinely calibrated. Sec. 211. processing.
8. Such samples shall be representative and properly identified. [43 FR 45077. or closure that is subject to deterioration.160(b)(4). and recording devices not meeting established specifications shall not be used. Instruments. apparatus.194 Laboratory records.quality standards and industry regulations and labeling used in the manufacture. (4) The calibration of instruments. and provisions for remedial action in the event accuracy and/or precision limits are not met. apparatus. The specifications shall include a description of the sampling and testing procedures used. apparatus. (d) Complete records shall be maintained of the periodic calibration of laboratory instruments. and recording devices at suitable intervals in accordance with an established written program containing specific directions. 29. schedules. drug product container. Sept. packing. gauges. 211. (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. limits for accuracy and precision. or holding of drug products. Such samples shall be representative and properly identified. 2008] Sec. 17 . gauges. 1978. as amended at 73 FR 51932. and recording devices required by 211. Such procedures shall also require appropriate retesting of any component. Samples shall be representative and adequately identified. processing. gauges. Sept. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials.
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.
including the dates and identity of people who carried these operations out. calibrations.quality standards and industry regulations Procedures and records Other 4. • Maintenance. • Supplier audits. clothing and hygiene and verification of the effectiveness of training. • Summaries of records where appropriate (e. procedures. • Internal quality/GMP compliance audits. and areas where product has been processed. product quality review). for the following examples: • Validation and qualification of processes. protocols. • Personnel matters including signature lists. • Returns. • Environmental monitoring. 22 .31 Logbooks should be kept for major or critical analytical testing. • Complaints. • Change control. any use of the area. as appropriate. They should be used to record in chronological order. production equipment. • Pest control. equipment/method. maintenance. • Investigations into deviations and non-conformances. 4.29 There should be written policies. • Technology transfer. equipment and systems. cleaning or repair operations.g. • Recalls. cleaning and sanitation. where appropriate. • Equipment assembly and calibration. reports and the associated records of actions taken or conclusions reached. training in GMP and technical matters.
piping. 12. • testing procedures and records (including analytical worksheets and/ or laboratory notebooks). Installation qualification (IQ ) should be performed on new or modified facilities. • analytical reports and/or certificates. Annex 15 to the EU Guide to Good Manufacturing Practice Title: Qualification and validation QUALIFICATION Installation qualification 11. An important part of this documentation deals with Quality Control and the following details should be readily available to the Quality Control Department: • specifications. systems and equipment. (d) verification of materials of construction. (c) icalibration requirements. (b) icollection and collation of supplier operating and working instructions and maintenance requirements. but not be limited to the following: (a) installation of equipment. where applicable. 23 . • validation records of test methods. IQ should include.quality standards and industry regulations Chapter 6 Quality Control Good Quality Control Laboratory Practice Documentation 6. where required.7 Laboratory documentation should follow the principles given in Chapter 4. • procedures for and records of the calibration of instruments and maintenance of equipment. • data from environmental monitoring. services and instrumentation checked to current engineering drawings and specifications. • sampling procedures.
operating procedures and operator training procedures and records should be documented. preventative maintenance. (g) additional testing to be carried out. systems and equipment 19. operator training and preventative maintenance requirements. The completion of a successful Operational qualification should allow the finalisation of calibration.quality standards and industry regulations Operational qualification 15. (k) proposed timetable. with acceptance criteria and analytical validation. but not be limited to the following: (a) short description of the process. (b) summary of the critical processing steps to be investigated. (e) list of analytical methods. Evidence should be available to support and verify the operating parameters and limits for the critical variables of the operating equipment. as appropriate. Qualification of established (in-use) facilities. (i) methods for recording and evaluating results (j) functions and responsibilities. 24 . It should permit a formal “release” of the facilities. the calibration. operating and cleaning procedures. Additionally. systems and equipment. (h) sampling plan. PROCESS VALIDATION Prospective validation 24. (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. Prospective validation should include. (f) proposed in-process controls with acceptance criteria. cleaning. as appropriate.
htm PDF of Annex 11: http://ec. This document provides guidance for the interpretation of the principles 25 .eu/health/files/eudralex/vol-4/annex11_01-2011_ en. 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.quality standards and industry regulations EU GMP Annex 11 The EU GMP Annex 11 defines EU requirements for computerised systems. and applies to all forms of computerised systems used as part of GMP regulated activities. Main page for the EudraLex .eu/health/documents/eudralex/vol-4/index_en.europa.europa.pdf EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels.Volume 4 Good manufacturing practice (GMP) Guidelines: http://ec.
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. It aims to promote harmonisation of global regulations for the pharmaceutical industry. 26 . Further information can be found at the PIC/S Web site (http://www. B-1049 Bruxelles / Europese Commissie.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. A computerised system is a set of software and hardware components which together fulfill certain functionalities. The application should be validated. picscheme. Consequential amendments are also proposed for Chapter 4 of the GMP Guide. Where a computerised system replaces a manual operation.org/.).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. process control or quality assurance. There should be no increase in the overall risk of the process. Deadline for coming into operation: 30 June 2011 Commission Européenne. B-1049 Brussel . 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. IT infrastructure should be qualified. there should be no resultant decrease in product quality.
COPs provide networking opportunities for people interested in similar topics. The GAMP® COP organizes discussion forums for its members and ISPE organises GAMP® related training courses and educational seminars.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® Nordic. Several local GAMP® COPs. This is the latest major revision and was released in January 2008. 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 .quality standards and industry regulations GAMP® GAMP® is a Community of Practice (COP) of the International Society for Pharmaceutical Engineering (ISPE). They also bring the GAMP® community closer to its members. produce technical content and translate ISPE technical documents. GAMP® Francophone. 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. GAMP® Italiano and GAMP® Japan. GAMP® Europe. GAMP® Japan. and GAMP® Americas support the GAMP® Council which oversee the operation of the COP and is the main link to ISPE. Switzerland). in collaboration with ISPE’s local Affiliates in these regions. Three regional Steering Committees. The most well known GAMP® publication is GAMP ® 5 A RiskBased Approach to GxP Computerized Systems. Austria. the organization entered into a partnership with the ISPE and published its first GAMP® guidelines. such as GAMP® Americas. GAMP® DACH (Germany. There is also a series of related GAMP® guidance on specific topics. The GAMP® COP aims to provide guidance and understanding concerning GxP computerized systems.
documentation. • Establish monitoring and measuring processes (calibration procedures and calibration record templates for recording your calibration results). this is what is required according to ISO 9001:2008 7. providing a structured approach to instrument risk assessment. A set of associated attachments are also available through the ISPE website. and corrective actions vital to regulatory compliance. The second edition of the guide has been significantly updated to address the change in regulatory expectations and in associated industry guidance documents. The Guide describes the principles of calibration and presents guidance in setting up a calibration management system.quality standards and industry regulations • GAMP® Good Practice Guide: IT Infrastructure Control and Compliance • GAMP® Good Practice Guide: Legacy Systems The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (second edition) was developed by ISPE’s GAMP® COP Calibration Special Interest Group (SIG) in conjunction with representatives from the pharmaceutical industry and input from regulatory agencies.6 CONTROL MONITORING AND MEASURING EQUIPMENT • Identify your organization’s monitoring and measuring needs and requirements (if your test instrument makes a quantitative measurement. and select test equipment that can meet those monitoring and measuring needs and requirements. and analytical instrumentation. The scope now includes related industries. calibration program management. 28 . laboratory. • 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). ISO 9001:2008 Basically. All calibrations must be traceable to a national or international standard or artifact. it requires periodic calibration).
this is just as applicable when dealing with ISO as with any other standard or regulation.).3-2006 ANSI/NCSL Z540. These include first-. your test instruments may need to be qualified prior to use). Please keep in mind that if your calibration function and/or metrology department fall under the requirements of your company. second-. and your calibration standards). QSR. 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”. etc. this standard is applicable to all organizations performing tests and/or calibrations. and may have affected numerous items of test equipment over a period of time). ANSI/NCSL Z540.quality standards and industry regulations • Protect your monitoring and measuring equipment (this includes during handling. ISO 17025 ISO 17025 – General requirements for the competence of testing and calibration laboratories. preservation. and third-party laboratories. transportation. and shipping of all test instruments – to include your customer’s items. • Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out-ofcalibration (as stated in the FDA regulations. rather it be for compliance to an ISO standard (ISO 9001:2008 or ISO 13485) or an FDA requirement (cGMP. “When accuracy and precision limits are not met. You already fall under a quality system that takes care of your calibration requirements. especially when the out of tolerance item is a calibration standard. storage. According to ISO 17025.3-2006 – American National Standard for Calibration-Requirements for the Calibration of Measuring and Test Equipment. 29 . and when required. • 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. and laboratories where testing and/or calibration forms part of inspection and product certifications. then you do not have any obligation to meet the ISO 17025 standard.
service. international. Collectively. and government standards. and • the traceability of measurement results to the International System of Units (SI). 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. The “Supplier may be a producer. • the suitability of a calibration for its intended application. In addition. Part 11 of ANSI/NCSL Z540. The “Customer” may be a consumer. each term being interpreted in the broadest sense. Reference to this National Standard may be made by: • customers when specifying products (including services) required. or a provider of a product. and • balancing the needs and interests of all stakeholders. • the compatibility of measurements with the National Measurement System. and • assessment organizations in the audit. This National Standard is written for both Supplier and Customer. and other evaluations of calibration systems and their components. 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. certification. retailer. this National Standard includes and updates the relevant calibration system requirements for measuring and test equipment described by the previous standards. or information. vendor. 30 . • legislative or regulatory bodies. In implementing its objective.1 (R2002) and Military Standard 45662A. This is done through the use of a system of functional components. client. distributor. • agencies or organizations as a contractual condition for procurement. this National Standard describes the technical requirements for establishing and maintaining: • the acceptability of the performance of measuring and test equipment. industry. • suppliers when specifying products offered. or purchaser that receives a product or service.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. enduser. • applying best practices and experience with related national.
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.
for food weighed incorrectly at the checkout counter. and possibly the ability to stay in business simply because they do not use calibrated test equipment. Their R&D section sends the formula to their operations & manufacturing division. Because of poor or incorrect calibration. A fairy tale? Not hardly. or by using incorrect calibrations. They are not using calibrated test instruments in the company. Babies are not correctly weighed at birth. Incorrect amounts of ingredients in your prescription and over-the-counter (OTC) drugs can cost more. Crime labs cannot identify the remains of victims or wrongly identify victims in the case of mass graves. the cure for cancer is one of them. criminals are either not convicted or are released on bad evidence. or even cause illness or death. has found the cure for cancer. their reputation. If all test equipment were calibrated to a traceable standard. Let’s imagine that the Acme Biotech Co. The amount of drugs confiscated in a raid determines whether the offense is a misdemeanor or a felony. The cure cannot be replicated with consistent results. Measurements made by R&D are different than those made by the operations section. and for manufactured goods that do not meet their stated specifications. This scenario is repeated every day throughout the world. Airliners fly into mountaintops and off the ends of runways because they don’t know their altitude and/or speed. which weight is correct? As one can see. all of us pay more at the gas pump. having the correct measurements throughout any and all industries is critical to national and international trade and commerce. then repeatable results would ensure that what’s made in one part of the company is also repeated in another part of the company.a basic quality calibration program A basic quality calibration program R &D departments are tasked with coming up with the answers to many problems. money. Without calibration. The company loses time. 35 .
usually national or international standards. 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. Nothing could be further from the truth. the ‘everyday calibration technician’ is usually situated close to the bottom of the pyramid. and the unit under test (UUT) or test instrument that is being calibrated (the uncertainty is unknown. Many people are under the misconception that an item must be adjusted or aligned in order to be calibrated. or certain parts of the world. through an unbroken chain of calibrations all having stated uncertainties. The two examples in figures 1 and 2 are similar. By definition: Calibration is a comparison of two measurement devices or systems. and that is why it is being calibrated). The calibration of any piece of equipment or system is simply a comparison between the standard being used (with its known uncertainty). It does not make any difference if you adjust. It is as simple as that. nor if you cannot adjust or align it. Traceability is the property of the result of a measurement or the value of a standard whereby it can be related to stated references. but differ depending on where you are in the chain. However. before we go any further. one of known uncertainty (your standard) and one of unknown uncertainty (your test equipment or instrument). There are basically two ways to maintain traceability during calibration – the use of an uncertainty budget (performing uncertainty calculations for each measurement). publication reference (EAL-G12) Traceability of Measuring and Test Equipment to National Standards. let’s discuss the use of uncertainty budgets. First. we need to clarify two definitions that are critical to this subject – calibration and traceability. align or repair the item. no matter the circumstances is called calibration. Before we can get any deeper into what traceability is.a basic quality calibration program The bottom line is this – all test equipment that make a quantitative measurement require periodic calibration. we should explain two different traceability pyramids. When we talk about traceability to a national or international standard. so a graphic illustration of these pyramids is important. and using a test uncertainty ratio (TUR) of ≥ 4:1. According to the European cooperation for Accreditation of Laboratories.
37 .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. 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. and customers who install them with other parts.1 Traceability of measuring and test equipment to national standards by means of calibration is necessitated by the growing national and international demand that manufactured parts be interchangeable. paragraphs 4 and 5 are very specific in their requirements: 4 Why are calibrations and traceability necessary? 4. and the EN 45001 standard for the operation of testing laboratories. must measure with the ‘same measure’. supplier firms that make products.
was in proper working order and was used correctly for controlling a product. e. (e) reference to SI units. each step in the chain must be performed according to documented and generally acknowledged procedures. the results must equally be documented. 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. (b) measurement uncertainty. that adequate measuring and test equipment was chosen. calibrations must be repeated at appropriate intervals.2 There are legal as well as technical reasons for traceability of measurement. by reference to a systematic and fully documented system. Note: If binding requirements for the accuracy of measuring and test equipment have been stipulated.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.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. uncertainty required. is not affected by defects.g. stability of the equipment. usually a national or international standard. 5 Elements of traceability 5. the producer must be able to demonstrate. 4. the laboratories or bodies performing one or more steps in the chain must supply evidence for their technical competence. (c) documentation. 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. (f) re-calibrations. failure to meet these requirements means the absence of a warranted quality with considerable consequent liability. e. the chain of comparisons must end at primary standards for the realization of the SI units. by demonstrating that they are accredited. the length of these intervals will depend on a number of variables. way of use. 38 .3 If it becomes necessary to prove absence of liability. frequency of use. if they are used properly. 4.g.a basic quality calibration program 4. (d) competence.
published by seven international organisations concerned with standardisation and metrology. in addition to the general requirements of EAL-R1. 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. where the customer’s test 39 . to set up. This is correct and acceptable. Expression of the Uncertainty of Measurement in Calibration. then traceability is assured. 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. Keep in mind that a TUR of 4:1 somewhere along the chain of calibrations may not have been feasible. and uncertainty calculations were performed and their uncertainty stated on the certificate of calibration. the TUR shall be equal to or greater than 4:1. you must ensure your standards are at least four times (4:1) more accurate than the test equipment being calibrated. In most circumstances. without using uncertainty budgets or calculations. It is equally important that such reference materials are traceable to relevant SI units. reference materials take the position of physical reference standards. is at the company or shop level.2 In many fields.” So.1 The other document that goes hand-in-hand with this is EA 4/02. Certification of reference materials is a method that is often used to demonstrate traceability to SI units. if a TUR of equal to or greater than 4:1 is maintained. Where does this ratio of four to one (4:1) come from? It comes from the American National Standard for Calibration – (ANSI/NCSL Z540. The purpose of this document is to harmonise evaluation of uncertainty of measurement within EA. 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.2 By understanding and following both of these documents.a basic quality calibration program 5. the implementation of EA-4/02 will also foster the global acceptance of European results of measurement. To maintain traceability.32006) which states: “Where calibrations provide for verification that measurement quantities are within specified tolerances…Where it is not practical to estimate this probability.
They have calibrated the same items for several years and feel there is nothing new to learn. However. The four calibration technicians that have been following the calibration procedure improve their production and save the company money. They submit a change proposal for the calibration procedure and everyone is briefed and trained on the new technique. Process improvements cannot take place across the department if everyone is not doing the job the same way each and every time they perform a calibration. more economical way to perform a specific calibration. in a consistent output from those processes.a basic quality calibration program equipment is usually used for production or manufacturing purposes only. it is possible to initiate process improvements. The two ‘old timers’ have a reduction in their production and actually cost the company money. If everyone was using the calibration procedures like they were supposed to. If a change has been made to that procedure. The effective operation of such a system will hopefully result in stable processes and. But especially true in a metrology department. One of the four calibration technicians (who are always following the calibration procedures) finds there is a fast. Once stability and consistency are achieved. 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. and the appropriate documentation completed to show that training 40 . 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. This is applicable in every phase of a production and/or manufacturing program.3 Let’s take for example a calibration program that has six calibration technicians on staff. But they must have their calibration procedure on hand each time they are performing the calibration. Four of them work in another facility calibrating the same types of equipment as the other two. So how does calibration and traceability fit into the big picture? What does the big picture look like? Why do you need a quality calibration program? You need to establish a quality calibration program to ensure that all operations throughout the metrology department occur in a stable manner. Of course not. the calibration technician must be trained on the change before they can perform the calibration. therefore. then this would not have happened.
Here is an example of common formatting for SOPs: 41 .) and regulations throughout most industries that regulate or monitor production and manufacturing of all types of products. change a process. then it is the same as if the training never happened. This includes calibration procedures. you’re required to inform the user/owner of the equipment because they may have to re-evaluate manufactured goods. “Record what you did” means that you must record the results of your measurements and adjustments. Do what you say. This includes calibration procedures. or upper/lower limits specified in your procedures or instructions. “Say what you do” means write in detail how to do your job. “Do what you say” means follow the documented procedures or instructions every time you calibrate. and Act on the difference”.a basic quality calibration program was accomplished and signed off. All of your calibration procedures should be formatted the same as other SOPs within your company. work instructions and standard operating procedures (SOPs). These items are also referred to by other standards (ISO 9000. “Act on the difference” means if the test equipment is out of tolerance. Record what you did. or recall a product. Check the results. When the proper training is not documented and signed off by the trainer and trainee. etc. Let’s break these down into simple terms.3 “Say what you do” means write in detail how to do your job. The basic premise and foundation of a quality calibration program is to “Say what you do. work instructions and SOPs. 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 perform a function that follows specific written instructions. One of the most stringent requirements can be found in the current Good Manufacturing Procedures (GMP). accuracies. including what your standard(s) read or indicated both before and after any adjustments might be made. “Check the results” means make certain the test equipment meets the tolerances.
thermal cyclers. This table should also include the standard’s range and specifications. 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. Generic SOPs are written to show how to calibrate a large variety of items in a general context. Procedure 6. pipettes. Forms and Records 8. They should show what standards accomplish the calibration of a specific range and/or function. generally speaking. Possibly. Have the latest edition of the procedure available for use by your calibration technicians. Procedures. and balances/scales. Specific: spectrophotometers. Scope 3. along with their range and tolerances. A complete calibration must be performed prior to any adjustment or alignment. This means following published calibration procedures every time you calibrate a piece of test equipment. Procedures 2. power supplies and water baths. Manufacturer’s manuals usually provide an alignment procedure that can be used as a template for writing a calibration procedure. or perform a function that follows specific written instructions. Related Procedures 7. Specific SOPs are written to show stepby-step procedures for each different type of test instrument within a group of items. micrometers. pressure and vacuum gages. Document History After section 4. “Do what you say” means follow the documented procedures or instructions every time you calibrate. There are. After that you should have a list of the standards to be used to calibrate the items. you should have a table listing all of the instruments or systems that would be calibrated by that procedure. Definitions. two types of calibration procedures: Generic: temperature gages and thermometers.a basic quality calibration program 1. Then the actual calibration procedure starts in section 5. and removes doubt by the calibration technician on what data goes into which data field. Responsibilities 4. Definitions 5. the calibration form is designed to follow specific steps (number wise). Have a system in place for updating your 42 .
The location of where the test instrument can be found should also be on the record.a basic quality calibration program procedures. If an out-of-tolerance (OOT) condition is found. Train your technicians on the changes made to your procedures every time the procedure is changed or improved – and document the training. 43 . e. What do you do when you need to make an improvement. and keep your calibration records in a secure location. including what your standard(s) read or indicated both before and after any adjustments are made. The ‘As Found’ readings are what the test instrument read the first time that a calibration is performed. written process must be in place. adjustment or repair. their part number and range/tolerance. The date of calibration. Certain requirements must be documented in each calibration record. including: • pen and paper • “do-it-yourself ” databases. as well as the test instrument’s ‘As Found’ and when applicable ‘As Left’ readings.g. 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. The entire calibration is performed to see any part of the calibration is out of tolerance. Of course there are many ways to accomplish this. or update your calibration procedures and/or forms? A formal. A history of each calibration and a traceability statement or uncertainty budget must be included. 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. Excel. the last time it was calibrated. and the next time it will be due calibration should be on the form. There should be a place to show what the standard read. prior to alignment.
44 . If the item is found to be out-of-tolerance at that time. then proceed with the calibration. Compare this to the calibration of pressure gages where a pressure standard is set to a standard pressure. “As Left” readings are taken after repair. The UUT is treated the same as any OOT unit. Another example would be when preventive maintenance inspection is going to be performed on an item. make an adjustment. a final ‘As Left’ calibration would be performed. there would not be a problem since it was found to be in tolerance during the first calibration. collecting the ‘As Left’ readings for the final calibration record. collecting the ‘As Found’ data. and the UUT is read to see how much it deviates from the standard. If one were to stop at the point where an OOT is found. once the problem is found and repaired. It just dies and cannot be calibrated. In some circumstances. Then. This is why the entire calibration is performed prior to adjustment or alignment. This is a best practice policy that has been in use in the metrology community since calibration started. Not all UUTs would be considered OOT when “As Left’ readings are taken. The standard reading.a basic quality calibration program record the reading (on the standard and the UUT) and continue with the rest of the calibration to the end of the calibration procedure. alignment. Usually. One example when it would not be practical to set the standard and take a reading is during the calibration of water baths. there will be times when this is not possible. a complete calibration is again performed. The calibration is performed. but you would not have been able to collect the original “As Found’ readings. or adjustment. an ‘As Found’ calibration is performed. there is a good possibility that the adjustment affected other ranges or parts of the calibration. alignment or adjustment and that after a final adjustment was completed to bring the unit back into tolerance. will also be recorded on the calibration form. the standard is set at a predetermined output. and an ‘As Left’ set of data is collected. This should be noted in the calibration record. and the temperature standard is used to record the actual reading. while still meeting its specifications. However. The water bath is set to a predetermined temperature. In this type of situation. There will be times when an instrument has a catastrophic failure. it might be metrology department policy to adjust an item if it is more than ½ beyond its in-tolerance range. It would be obvious that something happened during the cleaning. after the UUT is adjusted to be as close to optimum as possible. Then the PMI is completed. from the working or reference standard you are using to calibrate the UUT.
3.”5 If the conditions within the area that calibrations are being performed require monitoring according to the standard or requirements that must be met. etc. They. recorded. As can be seen by the above examples. If this is the case. In other case. List environment conditions when appropriate and show if they pass or fail. monitored. then there should be a place in the calibration form for showing that those conditions were 45 . plus their specifications and range. along with their next calibration due date(s). along with the standard. or at least a statement that a TUR of ≥ 4:1 was met. and mitigated to meet calibration process requirements. humidity. paragraph 5. electromagnetic interference. and a determination is made as to the in or out of tolerance of the UUT. The same happens when calibrating thermometers. then a formal program must be in place for tracking those conditions and reviewing the data. along with the procedure’s revision number.”4 According to ANSI/NCSL Z540. Calibration shall be stopped when the adverse effects of the influence factors ad conditions jeopardize the results of the calibration. it is not always possible to set the standard and take a reading from the UUT. Note: Influencing factors and conditions may include temperature.3-2006. and their pressures recorded on the calibration record. Also on the calibration form should be an area to identify the standard(s) that were used. The UUT is compared to the reference after equilibration. dust. There should also be a place to identify which calibration procedure was used.a basic quality calibration program and the gage(s) under test are then read.11: “The calibration environment need be controlled only to the extent required by the most environmentally sensitive measurement performed in the area. are placed in a dry block and a particular temperature is set. 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. There must be a statement showing traceability to your NMI. or in the case of most companies in the USA. or to any artifact that was used as a standard. You should include any uncertainty budgets if used.6 Influence factors and conditions: “All factors and conditions of the calibration area that adversely influence the calibration results shall be defined. According to NCSL International Calibration Control Systems for the Biomedical and Pharmaceutical Industry – Recommended Practice RP-6. just as the calibration of autoclaves. and compared to the standard to see if they are in or out of tolerance. paragraph 5. to NIST. vibration.
even if internal to the company performing the calibrations. use whatever tracking system the software uses. or are not applicable to that calibration. The user/customer. Enough space should be available for the calibration technician to include information about the calibration. OOT conditions. and want to correct the error? For hard copy records. etc. • The user/customer was notified and the UUT was given a ‘limited calibration’ with their written approval. you find that you have made an error. what was accomplished if an OOT was found. or make a duplicate record from scratch with the correct data and explain in the comments block what happened. were not met. This means that an individual higher up the chain of command (supervisor. and then place your initials and date next to the data using black ink. there should be a place on the form for the final reviewer to sign and date. the calibration record must be signed and dated by the technician performing the calibration. with the following possibilities as an example: • The user/customer was notified and the UUT was adjusted and meets specifications. What do you do if. or erase the original data. or inspected before it is considered a completed record. You should indicate on the form if the calibration passed or failed. draw a single line through the entry. QA inspector. If this is the case. There should be only one way to file your records. • The user/customer was notified and the UUT was taken out of service and tagged as unusable. In some instances. Do not use white-out. There should be an area set aside in the calibration form for making comments or remarks. then there should be a place to show what happened to the UUT. after recording your results. This is called for in all of the standards and regulations. and date and sign accordingly.) must review the calibration record and also sign and date that it has been reviewed. both hard copy 46 . must be informed if their test equipment does not meet their specifications. or transposed the wrong numbers. manager.a basic quality calibration program either met. audited. the calibration record requires a ‘second set of eyes’. And finally. etc. Notice that in each circumstance that the user/customer must be notified of any and all OOTs. write the correct data. For making corrections to electronic records (eRecords). If the UUT had an out-of-tolerance condition.
or upper/lower limits specified in your procedures or instructions. review and store the data. It cannot be emphasized enough the criticality of validating your software. 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. There are various ways to do this. put it into your written procedures. and/or compilation into your forms. The use of computerized data collection brings with it not only increased productivity and savings in time and effort. etc. But the collection of data by electronic means. 47 . or through the use of calibration software. Hard copy records collected during the calibration of test instruments have been discussed in detail already. accuracies. In other cases it is not quite so apparent. analysis. but also new problems in how to collect. In some instances it is apparent what the tolerances will be for the items being calibrated..a basic quality calibration program and eRecords – no matter which system you use. “Check the results” means make certain the test equipment meets the tolerances. Is the system validated and instrumentation qualified prior to use? If you are using any type of computerized system. 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. process controllers. 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. data lines and storage systems when going entirely electronic with your calibration records and data management. manage. validation of that software is mandatory. should also be considered. Calibration forms should have the range and their tolerances listed for each piece of test equipment being calibrated.
• Are there any databases that need to be updated. you must inform the user because they may have to re-evaluate manufactured goods. or upper management notification in case of ‘in action’? 48 . or recall product. change a process or procedure. 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. supervisor or manager? • Is a data base maintained on all OOT test equipment? • Is the customer/user required to reply to the OOT notification. if so is there a time limit. 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. and a paper trail for historical reference? After owner/user notification.” You should have a written procedure in place that explains in detail: • What actions are to be taken by the calibration technician? • What actions to be taken by the department supervisor and/or manager? • What actions to be taken by the responsible owner/user of the OOT test equipment? You should have an SOP that explains the responsibilities of the calibration technician: • Do they have additional form(s) to complete when OOT conditions are found? • Do they require a ‘second set of eyes’ when/if an OOT is found? • Have they been trained and signed off that they know all the proper procedures when an OOT has been found? You should have an SOP that explains the responsibilities of the supervisor/manager: • Who notifies the customer – the technician. According to the FDA: “When accuracy and precision limits are not met.a basic quality calibration program “Act on the difference” means if the test equipment is out of tolerance.
Here is a hypothetical example: from an historical perspective. generally 85% of test equipment passes calibration. • 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.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.
The “Say what you do. poorly written calibration procedures. correct and properly used calibration and equipment labels. This can be accomplished using the manufacturer’s 50 . and Act on the difference” portion. the calibration management program should also be able to show calibrations and repairs by individual items. you can schedule your technicians. • If a higher fail rate is noticed. The same can be said of a quality calibration program. Those include: a master inventory list. check that the proper specifications are being used. the ability to see a 30 day schedule of items coming due calibration. From a managerial standpoint. Record what you did. and a visible safety program. etc. scheduling and calibration management software. Without any one of these programs. the unseen portion is what keeps the iceberg afloat and stable in the ocean. any software program used must be validated prior to implementation. Check the results.a basic quality calibration program operator error. But the different parts that keep a quality calibration program running efficiently consist of elements from a continuous process improvement program. Any calibration management program worth the money should have a few critical areas built into their basic program. Do what you say. a comprehensive calibration analysis program. bad cables/accessories.). However. environmental conditions (vibration. before changing calibration intervals. By knowing what is coming due calibration. and the ability to see all items that are currently overdue calibration. items that are OOT. groups of items by location/part number. According to most standards and regulations. bad standards. reverse traceability. standards. and other listings that help to manage your department. 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. This can be compared to the person who is trying to drain the swamp while fighting off the alligators. a quality calibration program would be impossible to maintain. Only about 10% can be easily seen by the casual observer. Developing a world-class calibration program A quality calibration program might be compared to an iceberg. an effective training program. 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. time and other resources to the best advantage.
handling. you are using your time more efficiently. or by incorporating an in-house validation system. return to finish the pipette or balance calibrations. A particular item used in a controlled environment should be more reliable that one used in a harsher situation. A best practice among experienced calibration practitioners is the calibration of like items. and the calibration technician is required to gown-up prior to entry every time then go into the clean-room. By not having to stand around to wait for the water baths to equilibrate. An example of this would be to calibrate all pressure gages that were shown to be stored or used in a specific area. depending on usage. then complete the water baths at their final setting. An example would be to start all temperature calibrations (set water baths up for their initial temperature readings). Calibration interval analysis software can be purchased commercially 51 . and keeping the calibration technician involved and focused instead of bored. Another critical yet often times misunderstood program is calibration interval analysis. or used as an item that is coded as “No Calibration Required” on a loading dock. you must consider if the test equipment is used to determine final product where specifications are very tight. Either way. 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. then scheduling all of the calibrations in that area could increase production and reduce down time from multiple entries and exits. then perform several pipette or balance calibrations. etc. and using your scheduling software to also perform calibrations in geographical areas or combining calibrations in local areas. Also. say outdoors in severe weather. Also. your validation paperwork needs to be available for inspection during audits and inspections. environment. return to set another temperature in the water baths (doing a few at a time). Combining the calibration of like items and mixing and matching items could reduce the task of mundane and boring calibrations.a basic quality calibration program system. increasing productivity. if calibrations were to be performed in a ‘clean room’ environment. This would be using your time to the best advantage. Each situation should be considered carefully so that they can be reviewed in the appropriate light. Most manufacturers recommend a 12 month calibration interval. or floor of a building.
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. Here is an example. It isn’t a question of do you have a quality calibration program in place. but one of the foundations for any quality system in the 21st century. • For each type of equipment. 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. On one side we have the requirement of standards and regulations that govern various companies. collect data over a one year period on: number of calibrations and number of items OOT • Take the number of calibrations minus the number of OOTs. divide result by the number of calibrations. 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. NCSL International has RP-1. in time and money. Both management and technical information are presented in this RP. Not only is calibration a requirement. Establishment & Adjustment of Calibration Intervals. This Recommended Practice (RP) is intended to provide a guide for the establishment and adjustment of calibration intervals for equipment subject to periodic calibration. recalls can be very expensive. but 52 . A company could also do their own analysis if they support a limited number of items. implement and manage calibration interval determination. or are on a tight budget and are willing to do their own computations. adjustment and evaluation programs. It provides information needed to design.a basic quality calibration program and used to evaluate your test equipment. The advantages and disadvantages of each method are described and guidelines are given to assist in selecting the best method for a requiring organization. Several methods of calibration interval analysis and adjustment are presented. Also.
shape. 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 . continuous process improvements. then it is assumed that to have a quality calibration program. document control procedures. a comprehensive calibration management software package. documented training for all your calibration technicians. calibration interval analysis. a training program. international. So is there cost and risk? Absolutely.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. you must also have all the parts needed to support traceable calibration: calibration procedures. time. In the case of companies that have untraceable calibration in the production of medical devices. calibration records. or intrinsic). 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. This would equate to not having any type of calibration program at all. pharmaceutical drugs and products that impact human safety – the cost could be immeasurable…with the possibility of death among the results. so the company would never be able to stay in business long enough to impact their market segment. money. traceable documentation. traceability or documentation. Referring to a double edged sword. and the ability to provide quality customer service in a timely manner. But it doesn’t end there. or quantity. an out-oftolerance program and procedures. Then you can say you have a quality calibration program. Without calibration to a traceable standard (national. Therefore there can be no quality in the product. The cost is huge in terms of lost production. and reputation. no matter the size. 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. there can be no repeatability. The basic belief is this – it is absolutely essential to have a quality calibration program in place to make a quality product.
4. RP-6. 54 . “If you cannot measure it. EA-4/02.3-2006. 2007. The Quality Calibration Handbook. 2006. Bucher. Boulder. NCSL. Jay L. 1999. 2. December 1999 rev00. ANSI/NCSL Z540. Calibration Control Systems for the Biomedical and Pharmaceutical Industry. malfunctioning. EAL-G12. CO. or in need of calibration As Lord Kelvin was quoted as saying. November 1995. contaminating or damaging it under normal operating conditions • Using their work order system for requesting service when equipment is broken. you cannot improve it. Expression of the Uncertainty of Measurement in Calibration. NCSL International. Traceability of Measurement. 5. 3. Edition 1.” 1. Milwaukee: ASQ Quality Press. Boulder.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. CO.
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. put new and tight requirements on the accuracy of process instruments and on process control. modern calibration techniques and calibration systems have made it easier to fulfill the requirements on instrumentation calibration and maintenance in a productive way.e. i. traceable calibration certificate. such as the ISO9000 and ISO14000 series of quality standards.e. we must first determine what measurement is and why measuring is necessary. However. Quality systems. but this topic should not be ignored. production processes and quality systems.traceable and efficient calibrations Traceable and efficient calibrations in the process industry T oday’s modern process plants. Calibration can briefly be described as an activity where theinstrument being tested is compared to a known reference value. Fortunately. The keywords here are ‘known reference’. 57 . call for systematic and well-documented calibrations. calibrator. Does this mean that the electricians and instrumentation people should be calibration experts? Not really. confidence levels etc. 1. terminology and methods involved in calibration must be known and understood in order to perform according to International Quality Systems. calibrator. uncertainty. repeatability. which means that the calibrator used should have a valid. To be able to answer the question why calibrate. with regard to accuracy. i. some understanding of the techniques.
” Therefore all instruments display false indications! A set of experimental operations for the purpose of determining the value of a quantity.” 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. HIERARCHY OF ACCURACY TRUE VALUE International National standard Authorized Laboratories Instr.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. Note: the true value of a quantity is an ideal concept and. in general. Departments House and working standards Process instrumentation 58 . it cannot be known.
the control cannot be better than the quality of measurements from the process. EVERYTHING IS BASED ON MEASUREMENTS PROCESS CONTROL SYSTEM MEASUREMENTS CONTROLS INSTRUMENTATION MEASUREMENTS ADJUSTMENTS Production Factors PROCESS Products 59 .traceable and efficient calibrations 2. manpower and capital into products in the best possible way. in other words. they drift and lose their ability to give accurate measurements. The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability. which must be done better than the competitors. Why calibrate The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability. optimization is done by means of process automation. Anyhow. energy. in other words. Why measure? The purpose of a process plant is to convert raw material. This conversion always involves optimizing. In practice. regardless of how advanced the process automation system is. 3.
while another performs differently. Even instruments of the same manufacturer. Environment conditions. type and range can show varying performance. One unit can be found to have good stability. which produces uniform quality and minimizes the negative impacts on the environment.traceable and efficient calibrations they drift and lose their ability to give accurate measurements. other quality systems and regulations The ISO9000 and ISO14000 can assist in guiding regular. elapsed time and type of application can all affect the stability of an instrument. Environment conditions. This drift makes recalibration necessary. systematic calibrations. elapsed time and type of application can all affect the stability of an instrument. 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. 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 .
1 ISO9001: 2008 The organization determines the monitoring and measurements to be performed. to ensure valid results. Regulatory requirements for calibration 5. This is done prior to initial use and reconfirmed as necessary. 5. identified for the determining of the calibration status. 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. safeguarded against adjustments that would invalidate the measurement result. Traceability is a declaration stating to which national standard a certain instrument has been compared. The organization then takes appropriate action on the equipment and any product affected. the basis used for calibration or verification is recorded. SI-UNITS International standards National standards Reference standards Working standards Process standards 61 . the ability of computer software to satisfy the intended application is confirmed. Where necessary. protected from damage and deterioration during handling. maintenance and storage. Records of the calibration and verification results are then maintained. In addition. Traceability Calibrations must be traceable. as well as the measuring devices needed to provide evidence of a product’s conformity to determined standards. Note: See ISO 10012 for further information.traceable and efficient calibrations 4. adjusted or re-adjusted as necessary. measuring equipment is calibrated or verified with measurement standards traceable to national or international standards at specified intervals. If no such standards exist. When used in the monitoring and measurement of specified requirements.
traceable and efficient calibrations 5. which add. and Security System to be able to comply with these regulations. • All electronic systems must comply with FDA’s 21 CFR Part 11. Food and Drug Administration) Any pharmaceutical company that sells their products in the USA must comply with FDA regulations. • Documented change management system must be in place. Software systems need features such as Electronic Signature. • Calibration standards must be more accurate than the required accuracy of the equipment being calibrated. • All instrumentation should have a unique ID. • There must be documented evidence that personnel involved in the calibration process have been trained and are competent. all product. An Audit Trail is required to support change management. Audit Trail. or delete data from an electronic record. U. • Calibration records must be maintained. Electronic Signatures” Software systems need features such as Electronic Signature. • Calibration standards should be traceable to national and international standards. Users must understand their responsibilities once they give an electronic signature. User Management. Audit Trail.2 PHARMACEUTICAL (FDA. • Calibrations must be done in accordance with written. • There should be a record of the history of each instrument. regardless of where the products are manufactured. • All instruments used must be fit for purpose.S. edit. Audit Trails should record all modifications. 62 . • A calibration period and error limits should be defined for each instrument. • 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. User Management. the Electronic Signature is considered equivalent to a hand-written signature. In such a system. and Security System to be able to comply with these regulations. approved procedures. process and safety instruments should be physically tagged.
Resolution Resolution is the smallest interval that can be read between two readings. including Annex 11.2. Validation Validation of measurement and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use. as described in Section 5. Non-linearity is specified by the Terminal Based method or the Best Fit Straight Line method.traceable and efficient calibrations 5.3 PHARMACEUTICAL (EU GMPs) Any pharmaceutical company that sells their products in the European Union must comply with EU GMPs. regardless of where the products are manufactured. Please note that the definitions listed here are simplified. 63 . Validation of measure ment and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use. The requirements for EU GMPs are similar to those of the US FDA. DEFINITIONS OF METROLOGICAL TERMS Some metrological terms in association with the concept of calibration are described in this section. 6. Non-linearity Non-linearity is the maximum deviation of a transducer’s output from a defined straight line. Calibration An unknown measured signal is compared to a known reference signal. Quite a few of the following terms are also used on specification sheets for calibrators.
are included in the accuracy figures provided. The accuracy of the reference value is generally not included in the figures. Repeatability is often expressed in the form of standard deviation. under normal operating conditions.S. which can be detected as an output. Good resolution is required in order to detect sensitivity. It must also be checked if errors like non-linearity. 64 Stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. under normal operating conditions. Repeatability Repeatability is the capability of an instrument to give the same output among repeated inputs of the same value over a period of time. temperature effects etc. The only way to compare accuracy presented in different ways is to calculate the total error at certain points. Hysteresis The deviation in output at any point within the instrument’s sensing range. . or % of RDG + adder. usually 90 days to 12 months. Temperature coefficient The change in a calibrator’s accuracy caused by changes in ambient temperature (deviation from reference conditions). Stability Often referred to as drift. Accuracy Generally accuracy figures state the closeness of a measured value to a known reference value. The temperature coefficient is usually expressed as % F. Accuracy is usually expressed % F.traceable and efficient calibrations Sensitivity Sensitivity is the smallest variation in input. / °C or % of RDG/ °C. hysteresis. when first approaching this point with increasing values. usually 90 days to 12 months. Drift is usually given as a typical value. stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period.S. and then with decreasing values. The difference between these two expressions is great.
etc. errors in calculation. It should be noted that. there will be an observable difference in the values measured. Type B uncertainty Type B evaluation of uncertainty involves the use of other means to calculate uncertainty. ambient conditions. Uncertainty is evaluated according to either a “Type A” or a “Type B” method. Standard deviation is used as a measure of the dispersion of values.traceable and efficient calibrations Uncertainty Uncertainty is an estimate of the limits.e. Examples of such errors include: errors in recording data. at a given cover factor (or confidence level). rather than applying statistical analysis of a series of measurements. uncertainty is calculated using Type A uncertainties. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. in an unpredictable manner. could be said to be of a systematic nature. which contain the true value. Type B. i. Values belonging to this category may be derived from: It should be noted that. The standard deviation. in general. Type A involves the statistical analysis of a series of measurements. Type A uncertainty The type A method of calculation can be applied when several independent measurements have been made under the same conditions. Type B uncertainty is used when the uncertainty of a single measurement is expressed. which can vary in magnitude and in sign. Examples of systematic effects include errors in reference value. If there is sufficient resolution in the measurement. In this case. for a series of measurements under the same conditions. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. 65 . the effects of these components include measurement errors. is used for calculation. often called the “root-mean-square repeatability error”. The other group of components. It involves the evaluation of uncertainty using scientific judgement based on all available information concerning the possible variables. Systematic errors or effects remain constant during the measurement. in general. set-up of the measuring. or the use of inappropriate technology.
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. k=2. A well-based Type B evaluation of uncertainty can be as reliable as a Type A evaluation of uncertainty. especially in a measurement situation where a Type A evaluation is based only on a comparatively small number of statistically independent measurements. should be used. In cases where normal (Gaussian) distribution can be assumed. CALIBRATION MANAGEMENT Many companies do not pay enough attention to calibration management although it is a requirement e. For uncertainty specifications. It is a skill that can be learnt with practice. Usually one of the following confidence levels are used: 1 s = 68% 2 s = 95% 3 s = 99% For uncertainty specifications. there must be a clear statement of cover probability or confidence level. The maintenance management system may alert when calibration is 66 . The expanded uncertainty corresponds to a coverage probability (or confidence level) of approximately 95%. the standard coverage factor. 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.g. there must be a clear statement of cover probability or confidence level. in ISO9001: 2008. 7.
There is no need to make tricky calculations manually in the field. etc. the software automatically detects the calibrator that was used.traceable and efficient calibrations needed and then opens up a work order. It automatically creates a list of instruments waiting to be calibrated in the near future. no printed notes. 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. Depending on what process variable is calibrated and how many calibration points are recorded. what happens between opening and closing of the work order is not documented very often. the work order will close and the maintenance system will be satisfied. it is usually in the form of a hand-written sheet that is then archived. Choosing professional tools for maintaining calibration records and doing the calibrations can save a lot of time. using automated tools can be 5 to 10 times faster compared to manual recording. While the calibration results are uploaded onto the database. finding the sheets requires a lot of effort. Thus the calibrator is able to detect if the calibration was passed or failed immediately after the last calibration point was recorded. effort and money. (s)he simply downloads the instrument details from the calibration management software into the memory of a documenting calibrator. If something is documented. An efficient calibration management system consists of calibration management software and documenting calibrators. 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. are needed. The increase in work productivity allows for more calibrations to be carried out within the same period of time as before. and the traceability chain is documented without requiring any further actions from the user. Unfortunately. Calibration records. The “As Found” and “As Left” are saved in the calibrator’s memory. and there is no need to write down anything with pen. Once the job has been done. The instrument’s measurement ranges and error limits are defined in the software and also downloaded to the calibrator. If the calibration results need to be examined at a later time. When the technician is about to calibrate an instrument. 67 . Modern calibration management software can be a tool that automates and simplifies calibration work at all levels.
In addition to the conventional mA output of a transmitter.traceable and efficient calibrations Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. When many tasks are automated. When an auditor comes for a visit. the users can concentrate on their primary job. are kept in the database. 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. Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. be possible. When an instrument has been calibrated several times. 68 . The requested calibration records can be viewed on screen with a couple mouse clicks. temperature and electrical signals including frequency and pulses. modern calibrators can also read HART. Good calibration tools help technicians work more efficiently and accurately. of course. therefore accessing previous results is also possible in just a few seconds. If the calibration management software includes the right tools. and they can be even used for configuring these “smart” transmitters. software displays the “History Trend”. it does not mean the job is an enormous one. When all calibration related data is located in a single database the software is obviously able to create calibration related reports and documents. For instance the maintenance manager can use it as a calibration planning and decision-making tool for tracking and managing all calibration related activities. One of today’s trends is to move towards to a paperless office. Foundation Fieldbus or Profibus output of the transmitters. It is not very uncommon to have a calibrator that calibrates pressure. QA will find a calibration management system useful. it is possible to use a “reverse traceability report” to get a list of instruments that have been calibrated with that calibrator. If paper copies of certificates are preferred. Today’s documenting calibrators are capable of calibrating many process signals. Although there is a lot of data involved. the system is easy to learn and use. which assists in determining whether or not the calibration period should be changed. Transferring to a new calibration system may sound like a huge task and it can be a huge task. If a calibrator drifts out of its specifications. instrument. it is possible to manage calibration records on computer without producing any papers. If the system manufacturer has paid attention usability. printing them must.
CONCLUSION A good. Electronic Signatures”  21 CFR Part 211: “Current Good Manufacturing Practice for Finished Pharmaceuticals” A good. etc. 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. planning. scheduling.traceable and efficient calibrations Nowadays most companies have instrumentation data in some type of electronic format: as Excel spreadsheets. Requirements”  21 CFR Part 11: “Electronic Records. 69 . analyzing and finally optimizing the calibration work. automated calibration system reduces workload. automated calibration system reduces workload because it carries out tasks faster. It assists in documenting. References  ISO9001: 2008 “Quality Management Systems. more accurately and with better results than what could be reached with a manual system. Maintenance databases.
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.
Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. chemical and pharmaceutical industries. harbors and retail outlets. Similarly. Product manufacturing also depends on accurate masses and so laboratories and production departments in the food and beverage. The stability of an instrument very much depends on its application and the environment it operates in. Fluctuating temperatures. This is particularly true for the food and beverage sector and for pharmaceutical manufacturers. aviation companies. an end product manufactured by a plant with poorly calibrated instruments could present a risk to both consumers and customers.why calibrate The costs and risks of not calibrating Unfortunately. It is therefore critical that all instruments are calibrated at appropriate intervals. calibration has costs associated with it and in uncertain economic times. However. this may even lead to a company losing its license to operate due to company not meeting its regulatory requirements. energy. . power. neglecting calibration can lead to unscheduled production or machine downtime. allowing that sensor to drift over time could potentially result in a risk to employee safety. These companies need to prove not only that the mass is accurate but also that the equipment producing the readings was correctly calibrated. who invoice customers based on the mass of what they supply (fiscal metering). Invoicing in these industries is often based on process measurements. Why is calibration important? Calibration ensures that instrument drift is minimized. In certain situations. Determining the correct mass of a product or material is particularly important for companies that supply steel. product and process quality issues or even product recalls and rework. oil and gas. Weighing instruments also need to be calibrated regularly. paper and pulp. Furthermore. There is therefore a growing need to have the metrological quality of these weighing instruments confirmed by calibration. if the instrument is critical to a process or is located in a hazardous area. 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. also need to calibrate their weighing instruments. harsh 74 Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements.
All product. process and safety instruments should also be physically tagged. In the power generation. uncertainty and confidence levels.why calibrate manufacturing conditions (dust and dirt) and elapsed time are all contributing factors here. Safety is another important reason to calibrate instruments. GMP. energy and utilities industries. a calibration interval and error limits should be defined for each instrument and standards should be traceable to national and international standards. enabled the reactor power in each unit to be increased by 1. approved procedures. by improving the measurement of reactor power parameters from 2% to 0. instrument calibration can help to optimize a company’s production process or to increase the plant’s production capacity.” Pharmaceutical manufacturers must follow current Good Manufacturing Practices. Incorrect measurements in a hazardous area could lead to serious consequences. The role of calibration is very important to ensure the quality and safety of the processes. ISO 9002 and ISO 14001 require systematic.4%. Typically. The role of calibration is very important to ensure the quality and safety of the processes. We must therefore ensure that all processes correspond to the planned characteristics. in addition to the BRC certificate of food safety. On the people side. at the Almaraz Nuclear Power Plant in Spain. which has a significant effect on annual production capacity. Standards must also be more accurate than the required accuracy of the equipment being calibrated. there must be documented evidence that employees involved in the calibration process have been properly trained and competent. Even instruments manufactured by the same supplier can vary in their performance over time. This affects all process manufacturers. repeatability. He comments: “For Heineken. The company must also have a documented change management system in place. For example. with all electronic systems complying with FDA regulations 21 CFR Part 11. Calibration also ensures that product or batch quality remains high and consistent over time. requires that calibration records are maintained and calibrations have to be carried out in accordance with written. Armando Rivero Rubalcaba is head of Instrumentation at beer producer Heineken (Spain). Furthermore.6%. well-documented calibrations with respect to accuracy. the quality of the beer is a number one priority. All the plants in Spain have received ISO 9001 and ISO 14001 certifications. 75 . Production environments are potentially high risk areas for employees and can involve high temperatures and high pressures. each instrument has a master history record and a unique ID. Quality systems such as ISO 9001.
this figure rises dramatically to more than 4 million US dollars per year. As he puts it: “Calibration is of great importance. according to recent research by Nielsen Research/ ATS Studies. for example. Therefore.” Today. This means that requirements for the calibrators are especially high. Preparation of the right rubber mixture is precision work and a sample is taken from each rubber mixture to ensure quality. The impact of even a small measurement error can be tremendous in terms of lost revenue. especially from the viewpoint of production safety and quality of the final product. measurement specialist at Mazovian Gas Company states: “Most importantly. 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. 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. petrochemicals and chemicals sectors. Customers want to pay for the exact amount of gas they’ve received.7 million US dollars every year. controlling emissions is another critical factor for many process manufacturers. Indeed. As Ed de Jong. Proper invoicing is therefore critical to energy and utilities companies. Calibrating instruments can help to make combustion more efficient in industrial ovens and furnaces. Similarly. manufacturers of food and beverage or pharmaceutical products could put their customers’ lives at risk by neglecting to calibrate their process instruments. especially from the viewpoint of production safety and quality of the final product. As Jacek Midera. 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 . poor quality calibration is on average costing manufacturers more than 1. When only large companies with revenues of more than 1 billion US dollars are considered.” Neglecting to calibrate process instruments can also affect a company’s bottom line profits. accurate measurements ensure proper billing. Instrument Maintenance Engineer at Shell (Netherlands) explains: “Until recently. gas conversion devices must be extremely accurate in measuring delivered gas. including sensors used for measuring CO2 and NOX emissions. Heikki Karhe is a measurement technician at the tyre manufacturer Nokian Tyres. particularly in the oil and gas. This is particularly true if sales invoicing is based on accurate process measurements. weighing scales or gas conversion devices. Measuring instruments that yield wrong values could easily ruin the final product.
This is simply not true. this does not eliminate the need for calibration.why calibrate involved for both customers and governments [fiscal metering]. How often they are calibrated depends on a number of factors. Just because a sensor is newly installed does not mean that it will perform within the required specifications. The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. instruments related to CO2 and NOX emissions. some manufacturers claim that they do not need to calibrate their fieldbus instruments because they are digital and so are always accurate and correct. calibration has an important role especially for the license to operate. Nowadays. this is not true. The optimal calibration interval for different instruments can only be determined with software-based history trend analysis. Quality standards may also dictate how often a pressure or temperature sensor needs calibrating. Another common misunderstanding is that new instruments do not require calibration. Although fieldbus transmitters have been improved in terms of their measurement accuracy when compared to analogue transmitters. The main difference between fieldbus and conventional transmitters is that the output signal is a fully digital fieldbus signal. all instruments require calibrating at set intervals. For example. a company is able to enter all the necessary instrument data to its calibration database or calibration management software. 77 . the manufacturer of the instrument will provide a recommended calibration interval. Changing the output signal does not change the need for periodic calibration. Government regulations demand that specific instruments must be calibrated. In this way. Again.” Common misconceptions There are some common misconceptions when it comes to instrument calibration. When to calibrate Due to drift. as well as begin to monitor the stability or drift of the instrument over time. for example. This interval may be decreased if the instrument is being used in a critical process or application. By calibrating an instrument before installation. First. highly stable sensors are not calibrated as often as those sensors that are more susceptible to drift.
documentation.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. the company must identify current calibration status for every instrument across the plant. execution. with documentation being a critical part of this. different companies from a diverse range of industry sectors use very different methods of managing these calibrations. But in order to understand how software can help process plants better manage their instrument calibrations. the calibration range and required tolerances need to be identified. These methods differ greatly in terms of cost. followed by the selection of suitable calibration methods and tools for execution of these methods. with documentation being a critical part of this. efficiency. pressure transducers and weighing instruments – require regular calibration to ensure they are performing and measuring to specified tolerances. The creation and approval of standard operating procedures (SOPs) for each device is then required. then classified into ‘critical’ and ‘non-critical’ devices. and accuracy of data and their level of automation. Calibration software is one such tool that can be used to support and guide calibration management activities. it is important to consider the typical calibration management tasks that companies have to undertake. Calibration software is one such tool that can be used to support and guide calibration management activities. There are five main areas here. 79 . Finally. quality. Plant instrumentation devices such as temperature sensors. Once this has been agreed. Careful planning and decision-making is important. organisation. However. comprising of planning and decision-making. Decisions then need to be made regarding the calibration interval for each instrument. and analysis. All plant instruments and measurement devices need to be listed.
Staff carrying out these activities must follow the appropriate instructions before calibrating the device. The calibration is then executed according to the plan. for example. the consequences could be disastrous for the plant. making notes of calibration results in the field. companies then have to analyse the data to see if any corrective action needs to be taken. although further instructions may need to be followed after calibration. This paperwork typically involves preparing calibration instructions to help field engineers. a safety problem or leading to batches of inferior quality goods being produced. The effectiveness of calibration needs to be reviewed and calibration intervals checked. and documenting and archiving calibration data. which may then have to be scrapped. process and quality engineers and managers – in using the chosen tools and how to follow the approved SOPs. The next calibration tasks then have to be scheduled. Documentation Documentation is a very important part of a calibration management process. The documentation and storage of calibration results typically involves signing and approving all calibration records that are generated. involves training the company’s calibration staff – typically maintenance technicians.why use software for calibration management All plant instruments and measurement devices need to be listed. organisation. ISO 9001:2008 and the FDA both state that calibration records must be maintained and that calibration must be carried out according to written. approved procedures. These intervals may need to be adjusted based on archived calibration history. then classified into ‘critical’ and ‘non-critical’ devices. The execution stage involves supervising the assigned calibration tasks. calibration labels need to be created and pasted. Based on the calibration results. then created documents copied and archived. resulting in costly production downtime. Resources then have to be organised and assigned to actually carry out the scheduled calibration tasks. The next stage. If. service engineers. including any associated safety procedures. 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 . 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. a sensor drifts out of its specification range.
a massive 75 per cent of companies carry out more than 2. The other 60 per cent of companies determined This means an instrument engineer can spend as much as 50 per cent of his or her time on documentation and paperwork – time that could be better spent on other value-added activities. 40 per cent of companies surveyed said that they calculated calibration intervals by using historical trend analysis – which is encouraging. Oil. Gas & Petrochemicals is similarly high.000 calibrations per year. different industry sectors have different requirements and regulations. many of these firms said they were doing it without any sort of calibration software to assist them. However. where 21 per cent of firms said they calibrated their instruments more than 2. Furthermore. whilst others used a calibration module within an existing Computerised Maintenance Management System (CMMS).000 calibrations each year. However. 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. with 55 per cent of companies performing more than 2. paper-based system. analysis of paper-based systems and spreadsheets can be almost impossible. In a recent survey conducted by Control Magazine. let alone time consuming. In the highly regulated pharmaceuticals sector. A significant proportion (almost 20 per cent) of those surveyed said they used a manual. Only a quarter of companies use calibration software In Beamex’s own Calibration Study carried out recently. Any type of paper-based calibration system will be prone to human error.why use software for calibration management When it comes to the volume of documentation required. just under a third of companies (with 500+ employees) typically have more than 5. This equates to a huge amount of paperwork for any process plant. 81 .000 instruments that require calibrating. In the Power & Energy sector. for example. but many firms still do this. the picture in reality can be very different. 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.000 calibrations each year. Many other companies said that they relied on generic spreadsheets and/or databases for this. 42 per cent of companies perform more than 2.000 times every year. Noting down calibration results by hand in the field and then transferring these results into a spreadsheet back at the office may seem archaic. The percentage is still quite high in the food & beverage sector.
Instrument ‘drift’ can be monitored closely over a period of time and then decisions taken confidently with respect to amending the calibration interval. Typically. for improved safety. these notes are then tidied up or transferred to another paper document. there seems to be some general challenges that companies face when it comes to calibration management. The number of instruments and the total number of periodic calibrations that these devices require can be several thousand per year. by analysing the calibration history of a flow meter that is located in a ‘non-critical’ area of the plant. easier and more accurate analysis of calibration records and identifying historical trends. potentially explosive area of the manufacturing plant.why use software for calibration management Using software for calibration management enables faster. a process plant may find it necessary to increase the frequency of some sensors that are located in a hazardous. Regardless of industry sector. Using software for calibration management enables faster. Rather than rely on the manufacturer’s recommendation for calibration intervals. paper-based system requires little or no 82 . Paper-based systems These systems typically involve hand-written documents. this might include engineers using pens and paper to record calibration results while out in the field. While using a manual. Furthermore. or they used a uniform interval across the plant for all instruments. after which they are archived as paper documents. For example. instrument calibration intervals based on either the manufacturer’s own recommendation. Companies could save so much time and reduce costs by using calibration management software to analyse historical trends and calibration results. the company may be able to decrease the frequency of calibration. easier and more accurate analysis of calibration records and identifying historical trends. Just as important. or by increasing the frequency where necessary. the plant may be able to extend these intervals by looking closely at historical trends provided by calibration management software. Plants can therefore reduce costs and optimise calibration intervals by reducing calibration frequency when this is possible. every instrument calibration has to be documented and these documents need to be easily accessible for audit purposes. Neither method is ideal in practice. How to plan and keep track of each instrument’s calibration procedures means that planning and scheduling is important. saving time and resources. On returning to the office.
Also. using an in-house legacy system to manage calibrations has its drawbacks. FDA) for managing calibration records. the calibration process itself cannot be automated. and Regardless of industry sector. production of reports. Although instrument data can be stored and managed efficiently in the plant’s database. In addition. Dual effort and re-keying of calibration data are also significant costs here. automatic alarms cannot be set up on instruments that are due for calibration. 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. but the calibration cannot be automated because the system is not able to communicate with ‘smart’ calibrators. there seems to be some general challenges that companies face when it comes to calibration management. Plant hierarchy and works orders can be stored in the CMM system. calibration data is typically entered manually into a spreadsheet or database. users are provided with an easy-to-use Windows Explorer-like interface. analysis and optimisation of calibration frequency. The software manages and stores all instrument and calibration data. but the recording of calibration information is still time-consuming and typing errors are common.why use software for calibration management investment. 83 . For example. In addition.g. In these systems. the calibration data is not easily accessible. it is very labour-intensive and means that historical trend analysis becomes very difficult to carry out. such as the scheduling of tasks and entry of calibration results. the CMM system may not meet the regulatory requirements (e. In-house legacy systems (spreadsheets. This includes the planning and scheduling of calibration work. etc. databases. communication with smart calibrators. The data is stored in electronic format. The system is time consuming. the level of automation is still low. Calibration software With specialist calibration management software. certificates and labels. soaks up a lot of resources and typing errors are commonplace. Furthermore.) Although certainly a step in the right direction.
Calibration instructions are created using the software to guide engineers through the calibration process. Benefits of using calibration software With software-based calibration management. Human error is minimised and engineers are freed up to perform more strategic analysis or other important activities. while automatic alerts for scheduled calibrations can be set up. Also. for example. easier and more accurate analysis of calibration records and identifying historical trends. automated calibration process.why use software for calibration management easy integration with CMM systems such as SAP and Maximo. Using software for calibration management enables faster. Organisation also improves. 84 . The result is a streamlined. The system no longer requires pens and paper. reports and labels can all be printed out on paper or sent in electronic format. The Change Management feature in Beamex’s CMX software. which improves quality. Using software-based calibration management systems in conjunction with documenting calibrators means that calibration results can be stored in the calibrator’s memory. Procedures and calibration strategies can be planned and all calibration assets managed by the software. Regulatory organisations and standards such as FDA and ISO place demanding requirements on the recording of calibration data. Audit Trail and Electronic Signature functions. plant productivity and efficiency. The software generates reports automatically and all calibration data is stored in one database rather than multiple disparate systems. enabling engineers to optimise calibration intervals using the software’s History Trend function. complies with FDA requirements. Execution is more efficient and errors are eliminated. Position. Calibration software has many functions that help in meeting these requirements. planning and decisionmaking are improved. device and calibrator databases are maintained. There is no re-keying of calibration results from a notebook to a database or spreadsheet. Documentation is also improved. such as Change Management. then automatically uploaded back to the calibration software. Locating records and verifying that the system works is effortless when compared to traditional calibration record keeping. Calibration certificates. Analysis becomes easier too. calibration software can facilitate both the preparation and the audit itself. These instructions can also be downloaded to a technician’s handheld documenting calibrator while they are in the field. when a plant is being audited.
Integration also enables the plant to automate its calibration management with smart calibrators. Beamex CMX Light is the most appropriate software. implementation. which is particularly beneficial if the company is replacing a lot of labour-intensive calibration activities. the calibration management software can utilise the records available in the CMM system database. multilingual users and a very large amount of instruments that require calibration. For medium-to-large sized companies that have multiple users who have to deal with a large amount of instruments and calibration work. as the entire calibration process is now streamlined and automated. Beamex CMX Professional is ideal. CMX Enterprise. Beamex’s high-end solution. only a few instruments require calibrating and where regulatory compliance is minimal. implementing software-based calibration management means overall costs will be reduced. calibration management software can be easily integrated to this system. Costly production downtime will also be reduced. For relatively small plants. Manual procedures are replaced with automated. If the plant instruments are already defined on a database. Benefits for all process plants Beamex’s suite of calibration management software can benefit all sizes of process plant. Here. as well as strict regulatory compliance. These savings come from the now-paperless calibration process. is suitable for process manufacturers with multiple global sites. Even if a plant has already implemented a CMM system. with no manual documentation procedures. which simply is not possible with a standalone CMM system. 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 . where calibration data is needed for only one location. validated processes. a central calibration management database is often implemented that is used by multiple plants across the world. For example. reduce costs and increase productivity by preventing unnecessary double effort and re-keying of works orders in multiple systems. The integration will save time. Engineers can analyse calibration results to see whether the calibration intervals on plant instruments can be altered.Business benefits For the business. those instruments that perform better than expected may well justify a reduction in their calibration frequency. Plant efficiencies should also improve. 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.
The business benefits of using software for calibration management • Cost reduction • Quality improvements • Increase in efficiency 86 . across all industry sectors. in-house built legacy calibration systems or calibration modules with CMM systems. Compared to traditional. paper-based systems. whilst 92% said that using CMX had improved the quality of their calibration system. 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. regardless of industry sector. using dedicated calibration management software results in improved quality. Summary Every type of process plant. 94% of CMX users stated that using Beamex products had improved the efficiency of their calibration processes. can benefit from implementing specialist calibration management software. increased productivity and reduced costs of the entire calibration process. only one quarter of companies who need to manage instrument calibrations actually use software designed for that purpose.why use software for calibration management SUMMARY Calibration software improves calibration management tasks in all these areas • Planning & decision-making • Organisation • Execution • Documentation • Analysis Beamex users Beamex conducted recently a survey of its customers. Despite these benefits.
safety issues or possibly leading to batches of inferior quality goods being produced. the time and resources required to carry out these calibration checks are often scarce. This can sometimes lead to instruments being prioritised for calibration. Adjusting calibration intervals based on history trend analysis Manufacturing plants need to be absolutely confident that their instrumentation products – temperature sensors. If sensors drift out of their specification range. but for other sensors that are deemed less critical to production. which then have to be scrapped. Most process manufacturing plants will have some sort of maintenance plan or schedule in place. By doing it. pressure transducers. Calibration history trend analysis is only possible with calibration software that provides this functionality. with increasing demands and cost issues being placed on manufacturers these days. a plant is able to define which instruments can be calibrated less frequently and which should be calibrated more frequently. flow meters and the like – are performing and measuring to specified tolerances. Plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’. the consequences can be disastrous for a plant. a function available within Beamex® CMX calibration software. However. which ensures that all instruments used across the site are calibrated at the appropriate times. resulting in costly production downtime.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. being calibrated less frequently or not at all. 89 . with those deemed critical enough receiving the required regular checks.
due to it being a highly regulated industry. manufacturing. including pharmaceuticals. the survey showed that from all industry sectors. But plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’. Interestingly. This type of practise is common in companies that employ an effective ‘Preventive Maintenance’ regime. 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. Cost savings can be achieved in several ways. Perhaps unsurprisingly. Second. ensuring that instruments are checked and corrected before they drift out of tolerance. the plant can analyze whether it should increase or decrease the calibration frequency for all its instruments. paper and pulp. by calibrating instruments more often when they are located in critical areas of the plant. is only possible with calibration software that provides this type of functionality. in the pharmaceuticals sector. 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. power and energy. the study proved also that the pharmaceuticals sector typically possesses a significantly higher number of instruments per plant that require calibrating. 90 . The survey covered all industry sectors. First. for example. With this function.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. 59% said they calibrated once a year and 30% said they calibrated twice a year. drifts in and out of tolerance over a given time period. chemicals. these plants also calibrate their instruments more frequently than other industry sectors. In addition. oil and gas. The analyses of historical trends and how a pressure sensor. by calibrating less frequently where instruments appear to be highly stable according to their calibration history. a function available within Beamex® CMX calibration software. 56% of the respondents said they calibrated their instruments no more than once a year. food and beverage. Current practices in process plants But in reality.
91 . 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. without doubt. As Mäki explains: “When an engineer buys a particular sensor. The function enables users to plan the optimal calibration intervals for their instruments. If it hasn’t. the historical trend) companies can reduce costs and improve their efficiencies. the engineer can now verify that the sensor he or she has purchased. He comments: “The largest savings from using the History Trend Option are in the pharmaceuticals sector. but all industry sectors can benefit from using the software tool. perhaps less obvious benefits of looking at the historical drift over time of a particular sensor or set of measuring instruments. the supplier provides a technical specification that includes details on what the maximum drift of that sensor should be over a given time period. can use the functionality to compare different sensor types to see which one best suits the new process. in setting up a new process line for example. Sensors that are found to be highly stable do not need to be re-calibrated as often as sensors that tend to drift. enables maintenance staff to concentrate their efforts only where they are needed.” The trick.how often should instruments be calibrated The benefits of analyzing calibration history trends But regardless of the industry sector. without of course sacrificing the quality of the product or process or the safety of the plant and its employees. actually performed within the specified tolerance over a certain time period. Pertti Mäki is Area Sales Manager at Beamex. With CMX’s History Trend Option. Doing this. he says. the engineer now has data to present to the supplier to support his findings. Calibration software such as CMX can also help with the planning of calibration operations. weeks. But there are other. therefore eliminating unnecessary calibration effort and time. is determining which sensors should be recalibrated after a few days. or even years of operation and which can be left for longer periods. He specialises in selling the Beamex® CMX to different customers across all industry sectors. This makes it an invaluable tool for maintenance or quality personnel who. says Mäki. by analysing an instrument’s drift over time (ie. 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.” But that’s not all. which helps companies identify the optimal calibration intervals for instruments.
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. Once implemented. 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. using the ‘Report Design’ tool option. 92 . allowing to evaluate the calibrations of a position or a device for a longer time period compared to the normal calibration result view. Also. the engineer can analyze how different devices are suited for use in a particular area of the plant or process. For example.how often should instruments be calibrated History Trend displays the instrument’s drift over a given period both numerically and graphically. the user can get an overview of how a particular device drifts between calibrations and also whether the drift increases with time. Reporting is straightforward and the user can even tailor the reports to suit his or her individual needs. History Trend displays the instrument’s drift over a given period both numerically and graphically. The ‘History Trend’ window enables users to view key figures of several calibration events simultaneously. Based on this information. maintenance personnel.
• The Beamex® CMX stores every calibration event into the database. • The Beamex® CMX also indicates when new devices have been installed and calibrated. the history trend is made automatically without any extra manual work. HISTORY TREND REPORT HISTORY TREND USER-INTERFACE The graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments. • The graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments.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. This helps in comparing differences between devices. 93 .
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 . 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.
or prior to use. measuring equipment shall a) be calibrated or verified at specified intervals. c) be identified to enable the calibration status to be determined. This shall be undertaken prior to initial use and reconfirmed as necessary. When used in the monitoring and measurement of specified requirements. b) be adjusted or re-adjusted as necessary. 95 . d) be safeguarded from adjustments that would invalidate the measurement result.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. the ability of computer software to satisfy the intended application shall be confirmed. The organization shall take appropriate action on the equipment and any product affected.4). maintenance and storage.2. where no such standards exist. e) be protected from damage and deterioration during handling. the basis used for calibration or verification shall be recorded.how often should instruments be calibrated ISO 9001:2008 quality management requirements 7. In addition. 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. against measurement standards traceable to international or national measurement standards. Records of the results of calibration and verification shall be maintained (see 4. Where necessary to ensure valid results. the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.
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.
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. significant benefits in minimising the use of paper. Far too many of these companies still use paper-based calibration systems. calibrating instruments is an enormous task that consumes vast amounts of paperwork. as businesses. a maintenance or service Far too many of these companies still use paper-based calibration systems. our consumption of paper is far higher than it needs to be. Other than helping to save our planet and reducing the number of trees cut down each year. amongst the process manufacturing industries. perhaps even a poster on the wall. Traditional paper-based calibration systems Typically. which means they are missing out on the benefits of moving towards a paperless calibration system. almost 4 billion trees or 35% of the total trees cut down across the world are used in paper industries on every continent (source: www. weighing instruments and pressure transducers. a paper-based calibration system involves the use of handwritten documents. Global consumption of paper has grown 400% in the last 40 years. software and electronic devices readily available today which render the use of paper in the workplace unnecessary. Today. Take the calibration of plant instrumentation devices such as temperature sensors. 101 . Take a minute to look around the room you are in and you’ll notice how many objects are made from paper: books. especially given that there are technologies. Whilst out in the field. Globally. printer paper. So let’s not add to this already heavy burden on our forests and the environment.com). As manufacturing companies. which means they are missing out on the benefits of moving towards a paperless calibration system. ecology. there are other. magazines.
paper records that need approval have to be routed to several individuals. these organisations can significantly reduce their paper consumption. workflow improves dramatically. While using a manual. in industrial environments.paperless calibration improves quality and cuts costs With paperless systems. Dual effort and the re-keying of calibration data into multiple databases become significant costs to the business. blank calibration certificates. After all. standard operating procedures (SOPs). In addition. workflow improves dramatically. Practical benefits of using less paper Aside from the financial benefits of moving towards a paperless calibration system. paper-based system requires little or no investment in new technology or IT systems. after which they are archived as paper documents. However. Paper systems are time consuming. there are practical reasons why firms should go paperless. workflow and making other significant cost savings for the business. With paperless systems. accessing calibration data quickly is not easy. important paper records could potentially be lost or damaged in an accident or fire. Often. engineer will typically use a pen and paper to record instrument calibration results. These same companies that use paper-based calibration systems are together generating hundreds of thousands (millions?) of paper calibration certificates each year. when these records can all be combined into a single electronic record? Improved workflow With paper-based systems. etc. every square foot of the business has an associated cost. these notes are then tidied up and/or transferred to another paper document. So why would these companies generate and store separate paper copies of important records such as works orders. it is not practicable to store or carry lots of paperwork. as those individuals who need to sign off records or calibration 102 . by utilising the latest software-based calibration management systems from companies like Beamex. which is time-consuming. they soak up lots of company resources and manual (typing) errors are commonplace. Furthermore. There will be less waiting time. On returning to the office. it is extremely labourintensive and means that historical trend analysis of calibration results becomes very difficult. whilst also improving quality.
When a plant is being audited. which again has cost reduction benefits to the business. Historical trending becomes easier. Calibration intervals can be optimised. calibration software facilitates both the preparation and the audit itself. Costly production downtime due to unforeseen instrument failures will also be reduced.paperless calibration improves quality and cuts costs documents can share or access electronic records simultaneously from a central database. For example. Business benefits For those more enlightened companies that use software-based calibration systems. as well as the cost of filing and storing those paper records. Paper records may not always reflect the truth. 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. Sometimes users may inappropriately modify the results data due to work pressures or lack of time/resources. particularly when using weighscales or other instruments that are open to an individual’s own interpretation of the data. electronic records enable easier analysis of data. manual errors such as misreadings can occur. faster and more reliable. engineers and management will have more confidence in Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. this means that operators. particularly calibration results. whilst mistakes and manual errors will be virtually eliminated. Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. In turn. The cost and time associated with printing copies of paper documents is also eliminated. 103 . those instruments that are performing better than expected may well justify a reduction in their calibration frequency. Just as important. the business benefits are significant. The whole calibration process – from initial recording of calibration data through to historical trend analysis – will take less time. especially if these paper records need to be typed or transcribed to a computer system or database. For example. Illegible handwritten notes are also a problem. Locating records and verifying that the system works becomes effortless when compared to traditional paper-based record keeping.
The calibration data is shared with other business IT systems electronically. end-to-end workflows. In addition. Commissioning At plant commissioning times. Companies can go even further than this and use electronic records for works orders. A key part of paperless calibration records is the capture of data at point of work. 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. 104 . resulting in completely paperless. resulting in completely paperless. business management systems. in reality. and for control systems. end-to-end workflows. increased efficiencies and reduced plant downtime.paperless calibration improves quality and cuts costs the data. 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. In other words. many companies are neither completely paperless nor rely solely on paper-based systems – the process is sometimes a hybrid of the two. particularly when it comes to plant audits. Electronic data also provides an excellent foundation for ongoing plant operation and maintenance. How paperless should you go? Of course. Although handover by commissioning teams that use paper records is straightforward and of universal format. The un-editable electronic data stored on high performance multifunction calibrators can be uploaded to calibration management software for safe storage and asset management. often in difficult industrial environments that would make the use of portable office computers impractical. electronic records simplify the handover of plant and equipment. electronic records are easy to manipulate and can be re-used in different IT systems. 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. without needing to collect all the plant data again. data historians. technician friendly interfaces on industrialized PDA or tablet based hardware when manual data entry cannot be avoided. the calibration data is shared with other business IT systems electronically.
Amongst these customers is UK firm Croda Chemicals Europe. “It’s faster. paper-based systems. Education and training for users is critical. education and training services for customers. 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. easier and more accurate than our old paper-based procedures. including Pharmaceuticals. which may be used to dealing with traditional. Here.” says Wright.” Education and training for users is critical. which may be used to dealing with traditional. Validation. 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. as this will help companies to overcome the natural resistance to change amongst the workforce. Case study Beamex is helping many organisations to implement paperless calibration management systems. it is better to source the data electronically using documenting calibrators that are specifically designed for this task. Beamex provides comprehensive validation. training & education Paperless systems also need validating in the user’s own environment. paper-based systems. Based in East Yorkshire near Goole. the Croda plant uses pressurised vessels to purify lanolin for healthcare and beauty products.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.” Today. which coordinates data collection tasks and archives the results. as this will help companies to overcome the natural resistance to change amongst the workforce. 105 . as well as the sensors that monitor the incoming chemical additives and the outgoing effluent. Chemicals. “It’s saving us around 80 manhours per maintenance period and should pay for itself in less than three years. Croda uses the CMX calibration management software system from Beamex. Oil Gas & Petrochemicals companies. This includes a functionality check on all of the pressure instrumentation.
the plant will be fully ready for production operation. This article explains process instrument commissioning and the benefits of calibration during the commissioning phase. At the completion of commissioning. These activities are usually described as ‘cold commissioning’. Energizing power systems. Successful commissioning of process instrumentation is an essential requirement for ideal plant performance. is ready for commissioning when the plant has achieved mechanical completion. Commissioning may involve mock operations which are commissioning activities conducted to allow operational testing of the equipment and operator training and familiarization. A plant. What is process instrument commissioning? Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. or any defined part of a plant. calibration of instrumentation. 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. Pre-commissioning activities are those which have to be undertaken 107 . commissioning activities are those associated with preparing or operating the plant or any part of the plant prior to the initial start-up and are frequently undertaken by the owner or joint owner/ contractor team. testing of the control systems as well as verification of the operation of all interlocks and other safety systems are also typical commissioning tasks. operational testing of plant equipment.intelligent commissioning Intelligent commissioning C alibration plays a vital role in process plant commissioning and when installing new instruments. In general.
because the funds have been allotted to cover budget overruns. 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. personnel and cost of commissioning Since commissioning takes place toward the end of the project. It is essential to comprehend the scope and length of commissioning activities and include them in the initial project plan and budget allocations. 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. physically installing the field device.intelligent commissioning There are many reasons why instruments should be calibrated during the commissioning phase before start-up. connecting to and identifying the field device. in fact. plant operation and plant maintenance. and ensure this commitment is maintained. Basically. configuring the required parameters and testing the configuration and interface to other systems. The rate 108 . prior to operating equipment. Some companies employ specialized commissioning engineers. 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. and a schedule needs to be established for each task including benchmarks for monitoring purposes. and adverse incidents at the start-up phase can be avoided. The cost of process instrument commissioning is typically affected by the following issues: learning and familiarizing with the field device. As there are many cost factors in the commissioning process. it may cost more. An extra day taken for commissioning means the same to the plant owner as an extra day taken during designing or construction. and the re-commissioning activities have been completed to the extent where the owner approves the plant and can begin commissioning activities. these steps must be repeated with every field device that will be installed at the plant. there is a risk that the work may be under-resourced. Management. detailed planning of commissioning and plant handover are essential elements of the overall project plan and schedule as any other grouping of activities. 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. Commissioning requires a team of people with a background in plant design.
such as the Beamex® CMX Calibration Software. teamwork and training are all essential. and the size of the team and composition of specialists depends on the nature and scope of the system. coordination. instrument and process engineers. instruments are often recalibrated upon arrival at the site.g. of commissioning is measurable (e. thereby enabling progress to be reviewed regularly. However. Calibration and the commissioning of field instrumentation New process instrumentation is typically configured and calibrated by the manufacturer prior to installation. especially if there has been obvious 109 . documentation.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. The commissioning team consists of a mixture of specialists. communications. number of loops or sequence of steps tested per day). Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. Sequence of activities leading to commissioning and acceptance of a plant. Good planning.
The new uninstalled instrument or transmitter may have the correct. However. weeks. Transmitters that are found to be highly stable need not be recalibrated as often as transmitters that tend to drift. such as the Beamex® CMX Calibration Software. when the initial planned specifications have been changed. it is possible that the original planned settings are not valid anymore and they need to be changed. as was explained in the previous paragraph. the fact that an instrument or transmitter is new does not automatically mean that it is within required specifications. the calibration serves also future purposes. Monitoring the quality and stability of a transmitter When calibration procedures are performed for an uninstalled instrument. There are also many other reasons why instruments should be calibrated during the commissioning phase before start-up. as well as to monitor the instrument’s stability. Assuring transmitter quality First of all. or years of operation and which can be left as is for longer periods without sacrificing quality or safety. By calibrating an instrument you can check the settings of the instrument. Calibration is therefore a key element in the process of reconfiguring an uninstalled transmitter. 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. specified settings. You can check the overall quality of the instrument to see if it is defective and to ensure it has the correct. weeks. or years of operation and which can be left as is for 110 . The trick is determining which sensors should be recalibrated after a few hours. it is possible to monitor the stability of the transmitter. After you have performed this task. Calibrating a new instrument before installing or using it is a quality assurance task. specified settings. By calibrating the transmitter before installation and on a regular basis thereafter. it is possible to reconfigure the transmitter. The transmitter information is critical in defining the quality of the instrument and for planning the optimal calibration interval of the instrument. Reconfiguring a transmitter The trick is determining which sensors should be recalibrated after a few hours.intelligent commissioning damage in transit or storage. The calibration database can be calibration software designed specifically for managing calibration assets and information.
which mean that they can be used to replace several individual measurement devices. overlooked or become overdue. 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. Using the CMX gives always a clear status of the transmitters. thereby eliminating unnecessary calibration work. The Beamex® CMX Calibration Software can be used for improving the quality. The Beamex calibrators support various different transmitter protocols. Integrated calibration solution by Beamex The Beamex® Integrated Calibration Solution. The Beamex® MC series documenting calibrators can be used for calibrating pressure. Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important. temperature. By using a documenting calibrator. 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 calibrators are all-in-one calibrators. 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.intelligent commissioning longer periods without sacrificing quality or safety. Foundation Fieldbus and Profibus. Engineers performing calibrations no longer have to write down any results on paper. electrical and frequency signals. does anyone perform the calibration (check in/out function) and what is the instrument/position status (pass/fail). productivity and cost-effectiveness of a plant’s calibration process. The Beamex® CMX can be used for planning and scheduling calibrations. Therefore. overlooked or become overdue. making the entire process much quicker and reducing costs. are they installed and ready for calibration. Intrinsically safe calibrators for potentially explosive environments are also available. 111 . smarter and more accurate management of all calibration assets and procedures. HART. managing and storing all calibration data as well as analyzing and optimizing the calibration interval. consisting of calibration software and documenting calibration equipment. for instance. such as analog. the calibration results are stored automatically in the calibrator’s memory during the calibration process. Doing so allows maintenance personnel to concentrate their efforts only where needed. improves the quality and efficiency of the entire calibration system through faster.
instead of typing the data manually into the calibration database. This means that engineers do not spend their time transferring the results from their notepad to final storage on a computer. again. therefore automatically produced when using the Beamex® Integrated Calibration Solution. 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 . The quality and accuracy of calibration results also improve. saving time and money. The calibration results are transferred automatically from the calibrator’s memory to the computer/ database.intelligent commissioning By using a documenting calibrator. 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. the calibration results are stored automatically in the calibrator’s memory during the calibration process. as there are fewer mistakes due to human error.
chemicals. having a reliable. special purpose machines. nuclear. pressure transducers. safety issues or batches of inferior quality goods being produced. Beamex® CMX. metal processing. paper. especially if the company is part of an asset-intensive industry. flow meters and the like – are performing and measuring to specified tolerances. Maintenance management has become an issue which deserves enterprise-wide and perhaps multi-site attention. furnaces. oil and gas. If sensors drift out of their specification range. where equipment and plant infrastructure is large. a small. but critical part of a company’s asset management strategy should be the calibration of process instrumentation. profitability and growth. conveyor systems or hydraulic pumps – is equally critical for these companies. has proved itself time and time again across many industry sectors. 115 . but critical part of a company’s asset management strategy should be the calibration of process instrumentation. boilers. Manufacturing plants need to be sure that their instrumentation products – temperature sensors. Maintaining plant assets – whether that includes production line equipment. is critical to business efficiency. including pharmaceuticals. For this. complex and expensive. a small. which then have to be scrapped.successfully executing a system integration project Successfully executing a system integration project F or process manufacturers today. perhaps resulting in costly production downtime. If stoppages to production lines due to equipment breakdowns are costly. seamlessly integrated set of IT systems across the plant. In the process industries. implementing the latest computerized maintenance management systems (CMMS) might save precious time and money. or across multiple sites. the consequences can be disastrous. In the process industries. Beamex’s calibration management software.
Seamless communication between CMX and ‘smart’ calibrators means that companies have the ability to automate predefined calibration procedures. CMX sends an acknowledgement order of this work back to the customer’s CMM system. in-house software for maintenance management. the customer and the CMM system software partner. As well as retrieving and storing calibration data. analyze and optimize their calibration work. Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems.successfully executing a system integration project Seamless communication Today. Beamex® CMX helps companies document. 116 . 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. in-house software for maintenance management. A data exchange module or interface that sits between the two systems is required. Seamless communication with calibrators also provides many practical benefits such as a reduction in paperwork. reminders and safety-related information. SAP or Datastream CMM system or even a company’s own. CMX also stores the complete calibration history of process instruments and produces fully traceable calibration records. Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems. elimination of human error associated with manual recording. Calibration work orders can easily be transferred to CMX Calibration Software. once the calibration work order has been executed. whether it is a Maximo. Integration project A customer may have a large CMM system and a considerable amount of data keying to perform before integration is complete. like procedures. SAP or Datastream CMM system or even a company’s own. CMX can also download detailed instructions for operation before and after calibrating. The integration project involves three main parties: Beamex. plan. All detailed calibration results are stored and available on the CMX database. most process manufacturers use some sort of computerized maintenance management system (CMMS) that sits alongside their calibration management system. Then. whether it is a Maximo. and the ability to speed up the calibration task. schedule.
The project manager is usually responsible for the operative management of the project. Installation. a project organization should be established and include members from both the supplier’s and the customer’s organization. 117 . agreement. tasks and authority of the project steering group must be defined as well as the decision-making procedures. The role. In addition. The role of each member should be defined and project managers appointed. It’s also essential that the main roles and responsibilities of the parties are specified before the project evolves.successfully executing a system integration project Project organization and resourcing In order to have a successful integration. project plan or other document annexed to the offer / agreement. A schedule is usually defined for the completion of the entire project as well as for the completion of each project phase. Testing 4. Moreover. The project steering group is responsible for making key decisions during the project. Project phases The integration project is divided into four main phases: 1. as a successful project requires input from both parties. Verification and Training The four main phases are also often divided into sub-phases. Scope of Work 2. it’s important that the right people and decision-makers are involved and participate right from the beginning of the project. The integration project involves three main parties: Beamex. a project steering group may need to be established. the customer and the CMM system software partner. Development and Implementation 3. Each project phase should be approved according to the acceptance procedures defined in the offer.
However. as changes to the original scope of work may be necessary and required even in projects where the SOW phase has been done carefully.successfully executing a system integration project Scope of work To ensure successful integration with a satisfied customer. 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. it is important that the supplier and customer agree on change management procedures as early as the starting phase of the project. main roles. 118 . The scope of work should include a brief project description. as the resourcing. The SOW is often developed through pre-studies and workshops. services provided. If the scope of work is not defined carefully. Defining what is not included in the scope of work is just as important as defining what is included in it. which will direct the project back to phase one where a review of the scope is necessary. defining the correct scope of work (SOW) is crucial. scheduling and costs of the project depend greatly on the scope of work. 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. partner responsibilities and the desired outcome. This means that establishing some framework and limitations for the project are also very important.
The testing. if required and agreed. When the integration is finished. the integration can enter the next phase. the customer has a system that saves time.successfully executing a system integration project Development and implementation When the scope of work has been defined and approved by both parties. assist with informing. approval procedures and timelines should be defined when agreeing on the project. training and providing training materials. in order to be able to continue the development work to next phase. Installation. which is the actual development and implementation of the project deliverables. The project manager at the buyer’s facility now plays a major role in the success of the integration process. verification and training The final stage in the integration process is the installation and testing at the customer’s facility and taking the system into production use. the customer has a system that saves time. Testing Testing occurs both during the project after each partial delivery. • Purpose / needs • Target • Supplier’s responsibilities • Customer’s responsibilities • Project management and project steering group Scope of work (SOW) Speciﬁcations documentation • Change management Development and implementation Implementation documentation • Testing and acceptance procedures Testing Testing documentation • Final approval by customer Installation Veriﬁcation Training Instructional documentation FOLLOW UP CLOSURE OF INTEGRATION PROJECT 119 . The supplier will. 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. reduces costs and increases productivity by preventing unnecessary double effort and rekeying of procedures in separate systems. and at the final stage of the project.
Savings from EAM are reasonably well-documented and come in various guises. better management of spare parts and equipment stocks.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. 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. Enterprise Asset Management. and optimized scheduling of maintenance tasks and resources. This improves the quality of the entire system. When there is no need to manually re-key the data. EAM is more than just maintenance management software. a corresponding increase in asset utilization or plant uptime. the data has to be as close to 100% accurate as possible to get maximum benefit from the system. systems. more efficient use of maintenance staff. Integrating a CMM system with calibration management software is an important step in the right direction when it comes to EAM. But the key to success is really the quality of information you put in the software. typing errors are eliminated. A CMMS integration will enable the customer company to automate its’ management with smart calibrators. Enterprise Asset Management. 120 . However. the most common benefits being: less equipment breakdowns (leading to a reduction in overall plant downtime). particularly with production teams.
Calibration in Industrial Applications .
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. safety or custody transfer. including frequency and pulses. 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.the benefits of using a documenting calibrator The benefits of using a documenting calibrator F or process manufacturers. The purpose of calibration itself is to determine how accurate an instrument or sensor is. the key final step in any calibration process – documentation – is often neglected or overlooked because of a lack of resources. Indeed. In plant areas where instrument accuracy is critical to ensure product quality. 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. and then automatically documenting the calibration results by transferring them to a fully integrated calibration management software. Some calibrators can read HART. temperature and electrical signals. 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. calibration every six months – or even more frequently – is not unusual. Although most instruments are very accurate these days. However. time constraints or the pressure of everyday activities. 125 . regular calibration of instruments throughout a manufacturing plant is common practice. Foundation Fieldbus or Profibus output of the transmitters and can even be used for configuring ‘smart’ sensors.
Calibration results have to be keyed manually into a separate database. the calibration procedure itself is critical. The quality and accuracy of calibration results will also improve. The engineer does not have to write any results down on paper. Product Manager at Beamex in Finland comments. especially if calibration is one of the many tasks that the user has to carry out in his daily maintenance routine. As Laurila states. spreadsheet or paper filling system. “Engineers. such as the 126 . are entered once into the calibration management software and then downloaded to the calibrator. again. but which also integrates and automatically transfers this information to some sort of calibration management software. Why use a documenting calibrator? The engineer does not have to write any results down on paper. The tolerances and limits for a sensor. as there will be fewer mistakes due to human error. receive instant pass or fail messages with a documenting calibrator. With instrument calibration. which makes the entire process much faster and consequently reduces costs. the calibration results are stored automatically in the calibrator’s memory during the calibration process. which makes the entire process much faster and consequently reduces costs. 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. or stores calibration data from instruments but is not integrated to a calibration management system. saving time and money. “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. Also. With a documenting calibrator. having an easy-touse documenting calibrator is definitely the way forward.the benefits of using a documenting calibrator Heikki Laurila.” A non-documenting calibrator is a device that does not store data. By using a documenting calibrator. This means the engineer does not have to spend time transferring the results from his notepad to final storage on a computer. The calibration results are automatically transferred from the calibrator’s memory to the computer/database.” With a multi-functioning documenting calibrator. as well as detailed instructions on how to calibrate the transmitter. the calibration procedure can be automatically transferred from the computer to the handheld calibrator before going out into the field. Performing the calibration procedure in the same way each time is important for the consistency of results. who are out in the field performing instrument calibrations.
___________________ * Reported to the Industrial Instrumentation and Controls Technology Alliance and presented at the TAMU ISA Symposium. the field engineer calibrates the instrument. 2004 Calibration software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. Benefits in practice Conventional calibration work relies on manual. “With a documenting calibrator. When you’ve got to calibrate instruments throughout a site. typically with five-point checks on each instrument. January. overlooked or overdue. such as the MC5 or the MC6. Both calibrators can be used also to calibrate. overlooked or overdue. 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. Oftentimes. 127 . configure and trim HART. the calibration process is much faster. and the system provides full traceability.” Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important. Foundation Fieldbus H1 or Profibus PA transmitters.the benefits of using a documenting calibrator Beamex® MC5 or MC6. 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. the user can download calibration instructions for hundreds of different instruments into the device’s memory before going out into the field. handwrites the results onto a paper form and then reenters this information into a database when he returns to the office. speed and accuracy are critical. the user doesn’t need to carry as much equipment while out in the field. paper-based systems for documenting. Laurila continues.* Why? Because the devices provide higher accuracy. Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. This means the user can work in the field for several days. 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 % . Manual calibration takes more time and is more prone to error. Unintentional errors often occur and the whole process is timeconsuming.
• No manual printing or reading of calibration instructions is required. saving time and money and simplifying the process. • Reduced costs from a faster and more efficient calibration process. again. • The calibration procedure itself is guided by the calibrator. • Improved accuracy. the system provides a full quality assurance report of all instruments calibrated along with a required calibration certificate.the benefits of using a documenting calibrator After completing instrument calibrations. • A fully traceable calibration system for the entire plant. This not only ensures full traceability but also reflects full and traceable documentation of the completed work. • Calibration results are automatically stored in the calibrator’s on-board memory during the calibration procedure. • Less paperwork and fewer manual errors. 128 . which uploads detailed instructions from the computer or calibration management software. 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. consistency and quality of calibration results. • Calibration results are automatically transferred from the calibrator’s memory to a computer or fully integrated calibration management system.
for example when invoicing is based on the weight of a solid material. whereas verification depicts the In any case. If a weighing instrument is used in a quality system. 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. Calibration is a means for the user to obtain evidence of the quality of weighing results. 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. usually called scales or balances. the quality of a weighing instrument is already defined in OIML regulations. should provide the correct weighing results. How the weighing instrument is used and how reliable the weighing results are can be very different. the user must define the measurement capability of it.calibration of weighing instruments part 1 Calibration of weighing instruments Part 1 F rom the point of view of the owner. Calibration depicts the deviation between indication and reference (standard) including tolerance. Calibration and legal verification Weighing instruments may also possess special features. From a regulatory point of view. The features may vary slightly from country to country. Using weighing instruments for legal purposes must have legal verification. weighing instruments. at least in Europe. 131 . Verification and calibration abide by a different philosophy. One of these features includes making measurements for which legal verification is required. In any case. (S)He must select the weighing instrument and maintenance procedure to be used to reach the required measurement capability. at least at the stage when the weighing instrument is being introduced into use. but in the EU they are the same. and the user must have the knowledge to apply the information achieved through calibration.
this operation is known as calibration (or verification). if necessary. to be able to define the measuring tolerance. Confirming the capability of weighing instruments should happen by estimating the quality of the measuring device in the place where it will be used. 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. including information for other measuring devices. It is also handy for monitoring measuring systems. produces a calibration certificate – is the best way to achieve reliable information to use in comparisons. The practical work for both methods is very similar and both methods can be used to confirm measurement capability. The terminology and practices used previously for verifying measurement capability. which goes through the same steps for every calibration – calculates deviation and measuring tolerance.calibration of weighing instruments part 1 maximum permissible amount of errors of the indication. etc. such as repeatability. The method should be precise for achieving comparable results during all calibrations. One calibration provides information on a temporary basis and a series of calibrations provides time-dependent information. as long as legal verification is not needed. The method of calibration should be selected such that it provides sufficient information for evaluating the required measuring tolerance. eccentric load. We must remember that the quality of the evaluation of measuring tolerance depends on the collected information through calibration. However. this means investigating the efficiency of the weighing instrument. 132 . are based on these practices of calibrating and verifying. This is a feasible practice for all weighing. This type of program is able to store all the history of calibrated weighing instruments. we need more information about the weighing instrument. Comparing the indication of weighing instruments with a set standard gives the deviation or error. and. In practice. 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. and it displays the history of calibrations and in this way provides the user with comprehensive information concerning measuring capability. and for weighing technology in general. even if it was a question of general weighing (non-legal). Using a calibration program. hysteresis.
They possess several possibilities for adjusting parameters in measuring procedures. are familiar with these parameters and use them as protocol. Therefore. Calibration should be carried out using settings based on the parameters for normal use. Since there are several parameters in use. For this reason. 133 . If these values are exceeded. however. The user must define the limits for permitted deviation from a true value and required measuring tolerance. the idea is that the weighing instrument remains in good working condition until the next calibration. Calibration itself. Performing calibrations based on the measuring tolerance is better than doing routine measuring. the user must determine all of the external factors which may influence the proper functioning of the weighing instrument. is a short-term process. Calibration itself. the function of weighing instruments. regular monitoring of the zero point and the indication number with a constant mass. However. It is very important that the users of the weighing instruments.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. however. the user must evaluate the process of measuring tolerance and compare this value with the required measuring tolerance of the process. 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 important to always have the manual for using the weighing instrument easily available to the user. 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. 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. an adjustment or maintenance is necessary. Today. a quality system is usually concerned with the traceability of measurements and the known measuring tolerance of the measurements made. as well as calibration personnel. is a short-term process. is based on microprocessors. as well as many other instruments.
134 . The following must be taken into consideration: • the type of procedure to be applied in confirming measuring tolerance • the interpretation of information while abiding by the calibration certificate • changing procedures based on received information Quality calibration methods and data handling systems offer state-of-the-art possibilities to any company. It also assists the user in obtaining the required quality of measurements in a process.calibration of weighing instruments part 1 SUMMARY Calibration (or verification) is a fundamental tool for maintaining a measuring system.
calibration of weighing instruments part 1 135 .
Weighing instruments are often highly accurate. often need to know just how inaccurate a particular scale may be. Typical calibration procedures Calibrating scales involves several different procedures depending on national. industries and households. tests for determining minimum weighing capability are also performed. which was prepared by the European Co-operation for Accreditation.e. or on the potential consequences of erroneous weighing results. often need to know just how inaccurate a particular scale may be. their customers and/or regulatory bodies. i. If you weigh the object Weighing instruments are often highly accurate. One clear and thorough guide is the EA-10/18. i.e. this information was obtained by classifying and verifying the equipment for type approval. 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. Originally. their customers and/or regulatory bodies. Subsequently.and/or industry-specific guidelines or regulations. 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. and published by the European Collaboration in Measurement and Standards (euromet). but users. the object being weighed is placed on the load receptor and the weighing result is read only once. Repeated weighing measurements provide different indications Usually. 137 . but users. the equipment was tested or calibrated on a regular basis.
g. their customers and/or regulatory bodies.calibration of weighing instruments part 11 repeatedly. 138 . Substitution mass should also be used if the construction of the scale does not allow the use of standard weights. which can be assuredly and accurately measured using the scale in question. suitable substitution mass is used instead. A truck scale is unsuitable for weighing letters The purpose of the minimum weight test is to determine the minimum weight. The repeatability test involves weighing an object several times to determine the repeatability of the scale used.1% of the weight. it may be impractical to use standard weights for calibrating the entire range. This is sometimes difficult due to the shape or construction of the object being weighed. This condition is met if the measurement error is less than 0. i. Typical calibration procedures include the eccentricity test. Combined standard uncertainty of the error U(E) Knowing the error of the scale indication at the point of each calibration is not sufficient.e. This enables you to correct the errors and definitions for non-linearity and hysteresis. In such a case. There are several sources of uncertainty of the error.: Weighing instruments are often highly accurate. If the scale’s maximum load limit is extremely large. often need to know just how inaccurate a particular scale may be. Center of gravity matters The eccentricity test involves placing the object being weighed in the middle of the load receptor as accurately as possible. You must also know how certain you can be about the error found at each point of calibration. random variation in the indications. 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. Test for errors in indication The weighing test examines the error of the indication on the scale for several predefined loads. but users. e. with a probability of 99. you will notice slight.73%.
is between is between 1.2 g. • Analogous scales have limited readability.8 g and 3. • The weights are not in the exact middle of the load receptor.4 g 1.7 g.5 g ±u(E) 68.g.9 g 4. air temperature and humidity.27%. • Air buoyancy around the weights varies according to barometric pressure. which correspond to one standard deviation of a normally distributed variable.27% as well.8 g 0. E = 2.calibration of weighing instruments part 11 • The masses of the weights are only known with a certain uncertainty.27%). • Digital scale indications are rounded to the resolution in use.1 g 2.5 g and the actual error. which means that the calculated error in the indication is 2. • A substitute load is used in calibrating the scale.5 g and u(E) = ±0. • There are random variations in the indications as can be seen in the Repeatability Test. • Air convection causes extra force on the load receptor. 139 .27% U(E) = 2u(E) 95. with a coverage probability of 68. 1.73 % 3.2 g 3. The values of uncertainty determined at each point of calibration are expressed as standard uncertainties (coverage probability: 68.6 g Example: The calibration error and its uncertainty at the calibration point of 10 kg may be expressed e. The combined standard uncertainty of the error at a certain point of calibration has a coverage probability of 68.45 % U(E) = 3u(E) 99.
If the distribution of the indicated error cannot be considered normal.0039 kg 95. • Finer resolution is often used in calibration. barometric pressure and relative humidity of the air may vary. • The temperature. then the error and its extended uncertainty at the point of calibration are E = 2.27% is insufficient.45%. If you are able to use the k = 2 coverage factor. or the reliability of the standard uncertainty value is insufficient.calibration of weighing instruments part 11 Expanded uncertainty in calibration U(E) In practice.45% of the time.9 g. Standard and expanded uncertainties of weighing results are calculated using technical data of the weighing instrument.5 g and the actual error.1 g and 3. However. at least once. • The adjustment of the weighing instrument may have changed. This means that the calculated error of the indication is 2.4 g. Typical reasons for this are: • Routine weighing measurements involve random loads. knowledge of its typical behaviour and knowledge of the conditions of the location where the instrument is used. Defining the uncertainty of weighing results is highly recommended. • Tare balancing device may be used in routine weighing. a coverage probability of 68. the indication of weighing an object of 10 kilograms will be between 10. its calibration results. then a larger value should be used for the k-factor. while calibration is made at certain calibration points.45% by multiplying it with the coverage factor k = 2. Normally. the uncertainty of the results of later routine weighings is usually larger. Uncertainty of a weighing result The purpose of calibration is to determine how accurate a weighing instrument is. • Routine weighing measurements are not repeated whereas indications received through calibrations may be averages of repeated weighing measurements. is between 1. • Loading/unloading cycles in calibration and routine weighing may be different. with a coverage probability of 95. • A load may be situated eccentrically in routine weighing. you know that if you repeat the calibration several times.5 g and U(E) = ±1.0011 kg and 10. As the above-mentioned case indicates. it is extended to a level of 95. 140 . for all The purpose of calibration is to determine how accurate a weighing instrument is.
It allows you to enter additional. Calculating the uncertainty of weighing results assists you in deciding whether or not the accuracy of the weighing instrument is sufficient and how often it should be calibrated. copying configurations from one scale to another is easy.calibration of weighing instruments part 11 typical applications and always for critical applications. Wide variation in user-specific limits is also possible. determining the uncertainty of weighing results is not part of calibration. Correspondingly. user-defined uncertainty components in addition to supported uncertainty components. Error limits can be set according to OIML or Handbook-44. Calibrating and testing weighing instruments using CMX CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument. CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument. However. CMX calculates combined standard uncertainty and expanded uncertainty at calibration of the weighing instrument. CMX’s versatile calibration certificate and possibility to define a user specific certificate assure that you can fulfill requirements set for your calibration certificates. 141 .
T/C). They either convert temperature into resistance (Resistance Temperature Detectors. they nevertheless do not determine the permanency of accuracy. Every temperature measurement is different. While standards determine accuracy to which manufacturers must comply.g. it is necessary to calibrate the instrument and the temperature sensor. they nevertheless do not determine the permanency of accuracy. including sensors. A temperature measurement consists of several time constants and it is crucial to wait until thermal equilibrium is reached before measuring. a model that includes all influencing factors must be created. show incorrectly. RTD’s are based While standards determine accuracy to which manufacturers must comply. Temperature sensors The most commonly used sensors in the industry used for measuring temperature are temperature sensors. which makes the temperature calibration process slow and expensive. It is important to keep in mind an old saying: all meters. Temperature greatly influences many physical features of matter. calibration will prove by how much. If temperature is a significant measurable variable from the point of view of the process. RTD) or convert temperature into low voltage (Thermocouples. quality. Therefore. For each measurement. energy consumption and environmental emission is significant.calibrating temperature instruments Calibrating temperature instruments T he most commonly and most frequently measurable variable in industry is temperature. 143 . Metrology contains mathematic formulas for calculating uncertainty. and its influence on e. the user must be sure to verify the permanency of accuracy. The polynoms are specified in ITS 90 table (International Temperature Scale of 1990). being a state of equilibrium. makes it different from other quantities. Temperature.
The most important criterion in the calibration of temperature sensors is how accurate the sensors are at the same temperature. Thermocouple consists of two different metal wires connected together. Many factors influence the total uncertainty. R. The uncertainty of calibration is not the same as the accuracy of the device. are also being adopted. it must be inserted into a known temperature. Despite their lower sensitivity (low Seebeck coefficient). while the transmitter converts the sensor signal. To make comparisons. transmitters with a digital output signal. and therefore the transmitter must be calibrated on regular basis. The most important criterion in the calibration of temperature sensors is how accurate the sensors are at the same temperature. and performing calibration is not the least influencing factor. Pt100 is a common RTD type made of platinum and its resistance in 0 ˚C (32 ˚F) is 100∧. The heat source may also have an internal temperature measurement that can be used as reference. Sensors are calibrated either by using temperature dry blocks for industrial field or liquid baths (laboratory).calibrating temperature instruments on the fact that the resistance changes with temperature. A temperature transmitter can be calibrated using a temperature calibrator. a small temperature dependent voltage difference/current can be detected. the transmitter converts the signal from the temperature sensor into a standard ranging between 4 and 20 mA. Therefore. All heat 144 . but to achieve better accuracy and reliability. we compare the sensor to be calibrated and the reference sensor. it also has an impact on the total accuracy. The most common T/C type is the K-type (NiCr/NiAl). such as Fieldbus transmitters. Nowadays. the noble thermo-elements S-. temperature transmitters were developed to convert the sensor signal into a format that can be transmitted easier. PtRh/Pt/Rh) are used especially in high temperatures for better accuracy and stability. This means that the thermocouple is not measuring the temperature. Most commonly.or B-type (PtRh/Pt. If the connections (hot junction and cold junction) are at different temperatures. Calibrating temperature instruments To calibrate a temperature sensor. an external reference temperature sensor is recommended. Temperature transmitters The signal from the temperature sensor cannot be transmitted a longer distance than the plant. but the difference in temperature.
stability and immersion depth. The major sources of measurement uncertainty are axial homogeneity. heat flux along the length of the thermometer stem. Immersion depth To achieve a more stable calibration. radial homogeneity. affects both the reference sensor and the unit being tested. the immersion depth for a probe should be sufficient for the sensor being calibrated. Loading effect When several sensors are placed in the borings of the heat source.01 (former EA-10/13). 145 . loading effect. This phenomenon is called loading effect. Thirty minutes is commonly used. Guidelines for minimizing measurement uncertainty should be applied according to Euramet/cg-13/v. The uncertainty of calibration is not the same as the accuracy of the device. These effects can be quantified to determine the heat source’s contribution to the measurement uncertainty. Radial homogeneity Radial homogeneity can be explained as the difference in temperature occurring between the borings.calibrating temperature instruments sources show measurement errors due to their mechanical design and thermodynamic properties. Stability Stability means variation of the temperature in the measurement zone over time when the system has reached equilibrium. Stem conduction. Measurement uncertainty Axial homogeneity Axial homogeneity is the temperature distribution in the measurement zone along the boring (axial temperature distribution). they will affect accuracy.
The calibration results can then be uploaded from the documenting calibrators to the Beamex® CMX Calibration Software. “This helps the client to follow the condition of the instrument. CEO of Beamex Group.calibrating temperature instruments The calibration of instruments and sensors must be performed periodically. 146 . regular calibration of sensors and traceable calibration as well as calibration documentation. you can print out a calibration report as well as a traceable. which is useful in making decisions about purchasing new instruments. “The temperature products and services we are now introducing form an integral part of the Beamex® Integrated Calibration Solution. However. the calibration device must always be more accurate than the instrument or sensor being calibrated. a complete calibration solution that enables faster. the calibration device must always be more accurate than the instrument or sensor being calibrated. where the computer controls the calibration event. smart reference probes and temperature calibration laboratory services. the calibration of instruments effecting production. calibration software and PC for online calibration. With the CMX Software. The instrument to be calibrated is connected to the calibrator controlled by a computer. The ISO quality control system presupposes the quality control of calibration. The Beamex® FB and MB dry blocks are part of the Beamex® Intergrated Calibration Solution. such as a series of highquality dry blocks for field and laboratory use. Calibration of instruments and sensors can be carried out either on site or in a laboratory. more efficient and accurate solution for calibrating temperature. Integrated calibration solution – a smarter way to calibrate temperature Beamex has introduced a smarter. both in numeric and in graphic form. more accurate and efficient management of all calibration assets and procedures”. It is a complete solution for temperature calibration with various products and services. The level of performance a calibration device needs to have depends on the accuracy requirements determined by each company. However. says Raimo Ahola. The instrument’s calibration information is saved in the calibrator and History Trend reports. The Beamex® Integrated Calibration Solution concept is the combination of calibrator. determining service in advance and recalibration. The dry blocks communicate with the Beamex documenting multifunction calibrators enabling fully automated temperature calibration and documentation.
eliminates any errors related to manual entry and assures repeatable calibration procedures”. calibration software and PC for online calibration. 147 . The Beamex® Integrated Calibration Solution concept is the combination of calibrator.calibrating temperature instruments accredited calibration certificate. Our integrated calibration solution concept saves valuable time. Mr Ahola adds.
Heat transfer fluids or pastes are sometimes used around or inside the insert. There are also some work safety issues that favor dry blocks in preference to liquid baths. They may actually even impede the dry block’s performance and damage its internal components.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. EURAMET The EURAMET guideline (EURAMET /cg-13/v. If a drop of water gets into hot silicon oil. an internal control sensor and optional readout for external reference sensor.01. but they don’t necessarily improve performance. There are fast and lightweight dry blocks for industrial field use as well as models that deliver near bath-level stability in laboratory use. it could even cause a small steam explosion which may splash hot oil on the user. It will also present how to calculate the total uncertainty of a calibration performed with a dry block. 149 . This article will focus on models that use interchangeable metallic multi-hole inserts. Dry blocks are almost without exception meant to be used dry. What is a temperature dry block? A temperature dry block consists of a heatable and/or coolable metallic block. in temperatures above 200 °C liquids can produce undesirable fumes or there may be fire safety issues. controller. For example. 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.
5 mm at –80…660 °C) (<= 1. • 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. Some manufacturers specify these components and some do not. With dry blocks. or to use an external reference temperature probe inserted in the block as a reference measurement. The Euramet calibration guide defines a normative way to calibrate dry blocks. the internal control sensor is typically located inside the actual block. Internal measurement as reference When using a dry block’s internal measurement as reference. As most of the manufacturers nowadays publish their product specifications including the main topics in the Euramet guide. the products are easier to compare. It is possible to use a dry block with the block’s internal measurement as the reference (true value). There is always thermal resistance between the internal sensor and the probes inside the insert and other sources of uncertainty need to be considered. 150 . whereas the probes to be calibrated are immersed in the insert.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. 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.total uncertainty of temperature calibration dry blocks.
Related uncertainty is caused. 151 . by the placement of the heaters. for example. • Axial uniformity Axial uniformity refers to the variation in temperature along the vertical length of the insert.total uncertainty of temperature calibration MAIN PARTS OF THE DRY BLOCK Stem conductance Sensor to be calibrated Reference sensor Axial uniformity Internal sersor Radial uniformity Uncertainty components that are related to temperature calibration are relevant to all manufacturers’ dry blocks. The thermocouple typically has its “hot junction” close to the tip of the probe whereas the PRT sensing element may be 30 to 50 mm long. Non-symmetrical loading or probes with significantly different thermal conductivity (for example large diameter probes) may cause additional temperature variation. • Radial uniformity Radial uniformity refers to the variation in temperature between the holes of the insert. With this in mind. “dry wells should have a zone of sufficient temperature homogeneity of at least 40 mm in length” at the bottom of the insert. The Euramet calibration guide states. a homogenous zone of at least 60 mm is recommended. thermal properties of materials and alignment of the insert holes. The purpose of this homogenous measurement zone is to cover various sensor constructions.
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. • Stability over time – Stability describes how well the temperature remains the same during a given time. As the probe constructions vary greatly (sheet material. the more the ambient temperature will affect the measurements.). The loading effect is not visible in the control sensor indication and the controller cannot completely compensate for this shift. If sufficient recommended immersion cannot be reached. Stability describes how well the temperature remains the same during a given time. The specifications for the above uncertainty components should be in the block’s specifications. If some component has not been specified. • Immersion Sufficient immersion is important in any temperature measurement. The hysteresis is greatest at the mid-point and is proportional to the temperature range. plus the length of the sensing element. Sufficient immersion depth and dual zone control helps to reduce load-related uncertainties. To minimize the stem conduction error it’s recommended. as a rule of thumb. it should be estimated or evaluated. • Hysteresis Hysteresis causes the internal sensor to be dependent on its previous exposure. when the system has reached equilibrium. to use immersion depth of 20 x the diameter. wall thickness.total uncertainty of temperature calibration • Loading effect Every probe in the insert conducts heat either from or into the insert. lead wire thermal conductivity etc. The Euramet calibration guide states that the immersion depth should be at least 15 x the probe’s outer diameter. The more the load. – The Euramet calibration guide defines stability as a temperature variation over a 30-minute period. a test for each individual probe type to be calibrated should be made. then the uncertainty caused by the insufficient immersion should be estimated/ evaluated. 152 .
the stem conductance has to be taken into account. mechanical robustness is usually inversely proportional to good performance: stability. the reference probe can be drawn out to match the immersion. the external reference sensor is inside the insert together with the probes to be calibrated. Unfortunately. It helps to minimize calibration uncertainty but also provides reliability in measurements. The internal sensor has to deal with quick temperature changes. In the case of using an external reference sensor. Using an external reference sensor enables more accurate measurement of the temperature of the probes to be calibrated. the external reference sensor is within the same calibration volume as the sensors to be calibrated. the user may obtain good results. There are many advantages to using a separate reference sensor. hysteresis. Therefore. Of course. vibration and possible mechanical shocks so it has to be quite a robust mechanically. 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. In many cases. The internal sensor is used just to adjust temperature close to the desired calibration point and keep it stable. etc. • Radial uniformity Radial uniformity is still present when using an external reference probe and should be taken into account as specified. If the reference sensor and the sensor to be calibrated are sufficiently similar in diameter and thermal conductivity. The loading effect is usually much less significant with an external reference sensor. In case the probe to be calibrated is short and won’t reach the measurement zone at the bottom of the insert. 153 . Using an external reference sensor enables smaller total uncertainty of the system. the external reference enables more accurate measurement of the temperature of the probes to be calibrated. the user can reduce the axial uniformity well below specification.total uncertainty of temperature calibration Using an external reference sensor as reference Unlike using the dry block’s internal sensor as a reference. • Loading effect Since the internal sensor cannot completely compensate the load related temperature shift inside the insert.
and the readout device’s uncertainty. 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. – Of course. However. the different loads. 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. for instance. It can be the block or an external device. – Uncertainty related to the reference probe components includes the probe’s calibration uncertainty. using an external reference does not automatically mean better results. It also helps the user to see when the unit has truly stabilized. stem conduction. All of the previously mentioned uncertainty factors need to be carefully considered. hysteresis. there may still be some difference between the block and the insert temperatures when the indicator shows the unit has stabilized. and it may often be smaller than the specification. • External reference sensor – The external reference sensor (PRT) is typically much more capable of producing accurate measurements than the internal sensor. the external reference sensor needs a unit that measures the sensor. drift. but depending on. Dry blocks usually have a stability indicator.
10 0.003 0. Finally the combined uncertainty has been multiplied by two to get the expanded uncertainty.007 0.028 All specifications have a rectangular probability distribution. In both cases the MB155R is used as the dry block.017 0. MB155R with internal measurement @0 °C Component Display Accuracy Hysteresis Axial Uniformity Radial Uniformity Stability Loading Effect Specification (°C) 0.135 °C).003 0.006 0. The various uncertainty components used in the examples can be found in the specifications in the product brochures.005 0.01 Combined Uncertainty: Expanded Uncertainty: MB155R and RPRT-420 Combined uncertainty: Expanded Uncertainty: 0.02 0.006 0.058 0.014 0. 155 .01 0. they are divided by the square root of three to get the Standard Uncertainty.012 0. When using an external reference sensor the total expanded uncertainty is 34 mK (0.012 0.020 Standard Uncertainty (°C) 0.004 0.003 0.007 0.025 0.034 °C).010 0.006 0. The standard uncertainties are combined as the root sum of the squares.005 0.029 0. As can be seen in the examples the total expanded uncertainty using the internal reference sensor is 135 mK (0.004 0.total uncertainty of temperature calibration CALCULATION EXAMPLES ■ Here are two examples of total uncertainty calculations. The temperature in both examples is 0 °C.05 Combined Uncertainty: Expanded Uncertainty: Standard Uncertainty (°C) 0.003 0.034 Standard Uncertainty (°C) 0.005 0.006 0.067 0.014 0.135 MB155R with external measurement @0 °C Component Axial Uniformity Radial Uniformity Stability Loading Effect Ref sensor measurement Specification (°C) 0. That is why they are divided by the square root of three to get Standard Uncertainty.01 0. One is done using the internal temperature measurement and the other with a reference probe.02 0. Due to the rectangular probability distribution of the specifications.006 Combined Uncertainty: Expanded Uncertainty: Reference Sensor (Beamex RPRT-420) Component Short-term repeatability Drift Hysteresis Calibration uncertainty Specification (°C) 0.01 0.
In the 1970s. the mA signal was introduced. Fieldbus transmitters are able to deliver a huge amount of information via the quick two-way bus. During the 1960s. smart transmitter was introduced in the 1980s. and I/O subsystems are required to convert the analog mA signal to a digital format for a control system. but how can it be done? 157 . During the 1990s. The Fieldbus transmitters must be calibrated as well. making things much easier. History of fieldbus Back in the 1940s. Several transmitters can be connected to the same pair of wires. Being an open standard. The first fieldbus was introduced in 1988. instrumentation utilized mainly pneumatic signals to transfer information from transmitters. Each transmitter needs a dedicated pair of cables. But what is fieldbus and how does it differ from conventional instrumentation? Fieldbus transmitters must be calibrated as well.fieldbus transmitters must also be calibrated Fieldbus transmitters must also be calibrated F ieldbus is becoming more and more common in today’s instrumentation. Conventional I/O systems are no longer needed because segment controllers connect the instrument segments to the quicker. manufacturers battled to see whose fieldbus would be the one most commonly used. using first proprietary protocols. one way. The first digital. A standard was finally set in the year 2000 when the IEC61158 standard was approved. instruments from any manufacturer can be connected to the same fieldbus as plug-and-play. higher-level fieldbus backbone. but how can it be done? Conventional transmitters can deliver only one simultaneous parameter. computerized control systems began to make their arrival. and throughout the 1990s a number of various fieldbuses were developed.
The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus market. The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus markets. such as reduction in field wiring. one can say that the Foundation Fieldbus is dominating the North American markets and the Profibus is the market leader in Europe. Both Foundation Fieldbus and Profibus have reached such a large market share that both buses will most likely remain also in the future. 158 . or even a little bit more. both used in process instrumentation. There are also other advantages compared to conventional instrumentation. lower installation labour cost. offering maintenance savings. the total installation costs for a fieldbus factory is far less than conventional. Although fieldbus hardware may cost the same as conventional. Recent co-operation between Foundation Fieldbus and Profibus suppliers will further strengthen the position of these two standards. 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. Critical applications and hazardous areas have also begun to adopt fieldbus. There are also certain applications that prefer certain fieldbus installations despite the geographical location. For the most part. Future of fieldbus Currently. if it would not offer them benefits compared to alternative systems. and no need for conventional I/O subsystems. This is caused by many reasons.fieldbus transmitters must also be calibrated Foundation Fieldbus H1 and the Profibus PA. Other areas are more divided. One important reason is the better return on investment. A large portion of new projects is currently being carried out using fieldbus. were chosen as standards. Remote configuration also helps to support reduced downtime. less planning/drawing costs. Another big advantage is the on-line self-diagnostics that helps in predictive maintenance and eventually reduces the downtime. The improved system performance is important criteria for some plants. a large number of fieldbus installations already exist and the number is increasing at a huge rate. Fieldbus benefits for industry Obviously process plants would not start utilizing fieldbus.
The input is measured with a traceable calibrator. 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 is not possible to calibrate a fieldbus transmitter remotely. but you also need to have a way to read the output of the fieldbus transmitter. it does not eliminate the need for calibration. that make the periodic calibrations compulsory. “calibration” is often used to mean the configuration of a transmitter. Although modern fieldbus transmitters have been improved compared to older transmitter models. 159 . Although fieldbus hardware may cost the same as conventional. When fieldbus is up and running. the total installation costs for a fieldbus factory is far less than conventional. So it is not possible to calibrate a fieldbus transmitter using only a configurator or configuration software. such as quality systems and regulations. In some cases you can use a portable fieldbus communicator or a laptop computer with dedicated software and hardware. While your fieldbus and process automation systems are idle. Naturally these two people need to communicate with each other in order to perform and document the calibration. you need to find other ways to read the transmitter’s output. In terminology pertaining to metrology. or even a little bit more. There are also many other reasons. Reading the digital output is not always an easy thing to do.fieldbus transmitters must also be calibrated Fieldbus transmitters must also be calibrated The main difference between a fieldbus transmitter for pressure or temperature and conventional or HART transmitters is that the output signal is a fully digital fieldbus signal. The other parts of a fieldbus transmitter are mainly comparable to conventional or HART transmitters. Also. “calibration” means that you compare the transmitter to a traceable measurement standard and document the results. 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. Calibrating fieldbus transmitters The word “calibration” is often misused in the fieldbus terminology when comparing it to the meaning of the word in metrology. Changing the output signal does not change the need for periodic calibration. In fieldbus terminology.
The Beamex® MC6 can be used as a communicator for the configuration as well as a calibrator for the calibration of smart instruments with the supported protocols. time-consuming and may require an abundance of resources. 160 . The Beamex® MC6 can be used as a communicator for the configuration as well as a calibrator for the calibration of smart instruments with the supported protocols. The calibration results can be automatically stored into the memory of the MC6 or uploaded to calibration software.fieldbus transmitters must also be calibrated Fieldbus instruments are increasing in popularity and calibration can in many cases be cumbersome. The Beamex® MC6 will help to overcome these challenges by combining a full field communicator and an extremely accurate multifunctional process calibrator. There is no need for an additional communicator.
) and generates an output signal proportional to the measured input. The term “smart” is more of a marketing term than a technical definition. in order for a transmitter to be called smart. the digital communication protocol is the biggest difference compared to conventional transmitters. 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. for the engineers who need to configure and calibrate the transmitter.configuring and calibrating smart instruments Configuring and calibrating smart instruments S o called “smart” instruments are ever more popular in the process industry. the Beamex® MC6 –Advanced Field Communicator and 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. a modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. These new smart instruments bring new challenges to the calibration and configuration processes. What is a “smart” transmitter? A process transmitter is a device that senses a physical parameter (pressure. There is no standardized technical definition for what smart really means in practice. Furthermore. Engineers can A modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. produce diagnostics. A microprocessorbased smart transmitter has a memory that can perform calculations. etc. Generally. The vast majority of delivered instruments today are smart instruments. temperature. 163 . that will help to overcome these challenges. In any case. etc.
contain only a digital output. sensor type. but they need to have the possibility to communicate with the transmitter and read the digital signal. no analog signal. Configuration One important feature of a smart transmitter is that it can be configured via the digital protocol. It is crucial to remember that although a communicator can be used for configuration. including HART. 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. These parameters may include engineering unit. Some are proprietary protocols of a certain manufacturer. would be a transmitter with a purely analog (or even pneumatic) output signal. Foundation Fieldbus and Profibus PA protocols. The most common transmitter protocol today is the HART (Highway Addressable Remote Transducer) protocol. i.e. Since it also has the analog signal. Configuration of a smart transmitter refers to the setting of the transmitter parameters. The fieldbuses. etc. Smart transmitter protocols There are various digital protocols that exist among transmitters considered smart. This article will discuss “smart” transmitters. Foundation Fieldbus and Profibus are gaining a larger foothold on the process transmitter markets. Recently the HART protocol seems to be getting more boosts from the newest WirelessHART protocol. 164 . WirelessHART. That brings a whole new challenge . a non-smart transmitter. So in order to do the configuration. typically also called a communicator. it is not a reference standard and therefore cannot be used for metrological calibration. to support the selected protocol. it is compatible with conventional installations. you will need to use some form of configuration device.configuring and calibrating smart instruments no longer simply measure the output analog signal. Most of the protocols are based on open standards. A HART transmitter contains both a conventional analog mA signal and a digital signal superimposed on top of the analog signal. such as Foundation Fieldbus and Profibus. The configuration needs to be done via the communication protocol.how can the digital output be read? Thinking of the opposite of a smart transmitter.
or alternatively two separate singlefunction calibrators. calibration is a comparison of the device under test against a traceable reference instrument (calibrator) and documenting the comparison. a HART communicator is needed. If the calibration is done with a documenting calibrator. by using a calibrator. In this case calibration is quite easy and straight forward. Although the calibration formally does not include any adjustments. To calibrate a conventional. but in order to see what the transmitter output is. several types of devices may be needed and several people to do the job. it is not a reference standard and therefore cannot be used for metrological calibration. Calibration of a smart transmitter According to international standards. i. with output being a digital protocol signal. be calibrated? Obviously the transmitter input still needs to be generated/measured the same way as with a conventional transmitter. it will automatically document the calibration results. by using a calibrator. 165 . by definition a traceable reference standard (calibrator) is always needed. The calibration may. especially a mobile one. which can read the digital output. potential adjustments are often included when the calibration process is performed. However. However.configuring and calibrating smart instruments It is crucial to remember that although a communicator can be used for configuration. The 4–20mA output signal of a wired HART transmitter is calibrated the same way as a conventional transmitter. to do any configuration or trimming. therefore. or to read the digital output signal (if it is used). a device or software able to read and interpret the digital protocol is needed. you will need some device or software able to read and interpret the digital protocol. The transmitter input needs to be generated/ measured the same way as with a conventional transmitter. be a very challenging task.e. But how can a smart transmitter. For a real metrological calibration. Wired HART (as opposed to WirelessHART) is a hybrid protocol that includes digital communication superimposed on a conventional analog 4–20mA output signal. you can generate or measure the transmitter input and at the same time measure the transmitter output. to see what the transmitter output is.e. 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. analog transmitter. you need a dual-function calibrator able to process transmitter input and output at the same time. i. Sometimes it is very difficult or even impossible to find a suitable device.
typically only for one protocol (mostly HART) and offering very limited support. 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. oil and gas. 166 . All required electronics are built-in. 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. such as the pharmaceutical. which means that it is fast and easy to use. service as well as the petrochemical and chemical industries. and you can carry less equipment in the field. The results can be automatically stored into the memory of the MC6 or uploaded to calibration software. The MC6 also contains a full fieldbus communicator for HART. Foundation Fieldbus H1 and Profibus PA protocols. The MC6 supports all of the protocol commands according to the transmitter’s device description file. the smart transmitter’s input can be generated/ measured at the same time as reading the digital output. In practice. When it comes to configuration of the smart transmitters. There are some other “smart” process calibrators on the market with limited support for different protocols. Foundation Fieldbus and Profibus PA instruments. including power supply and required impedances for the protocols. It offers calibration capabilities for pressure. a separate communicator is needed in any case. the MC6 includes a full field communicator for HART. WirelessHART. With the Beamex® MC6. It has a large 5. high-accuracy field calibrator and communicator. About Beamex® MC6 Beamex® MC6 is an advanced. The MC6 is one device with five different operational modes. Any additional communicator is therefore not needed. The usability and ease-of-use are among the main features of the MC6. The operation modes are: meter. With the Beamex® MC6. temperature and various electrical signals. energy. food and beverage. The robust IP65-rated dustand water-proof casing.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. calibrator. ergonomic design and light weight make it an ideal measurement device for field use in various industries.
In conclusion. • Regulatory requirements. etc.configuring and calibrating smart instruments documenting calibrator. such as quality systems. In addition. especially when used in demanding process conditions. The MC6 also contains a full fieldbus communicator for HART. • To achieve high and consistent product quality and to optimize processes. Foundation Fieldbus and Profibus PA instruments. the MC6 is more than a calibrator. • Environmental reasons. • Economical reasons – any measurement having direct economical effect. the output protocol of a transmitter does not change the fundamental need for calibration. A short summary of the main reasons include. standards. So why would you calibrate them? First of all. • Safety reasons. 167 . • Even the best instruments and sensors drift over time. There are numerous reasons to calibrate instruments initially and periodically. the MC6 communicates with Beamex® CMX Calibration Software. data logger and Fieldbus communicator. environmental systems.employee safety as well as customer/patient safety. 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”. enabling fully automated and paperless calibration and documentation. safety systems.
For example. universities. Therefore. In addition. power generation. Even seemingly safe water treatment systems use combustible materials such as chlorine in their processes. are used in all industries. certain areas of food plants. may pose hazards as well. and in the home. Similarly. This means that certain areas of a water treatment plant may well be considered hazardous. hydrocarbons in mines. oil refineries. For example.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. If this were truly the case. Hydrocarbons and other flammable fluids are not limited to the petroleum and chemical industries. and chemical plants are flammable and are typically contained within vessels and pipes. in many locations. pharmaceuticals. water/ wastewater. many materials and fluids used in seemingly “safe” industries are themselves flammable. such as natural gas. Improperly calibrating an instrument in this hazardous environment can be almost as dangerous. abnormal conditions. an external flame would not ignite the hydrocarbons. food. and fluid accumulation may allow hydrocarbons to be present such that the flame could ignite the hydrocarbons with disastrous results. such as reactors that hydrogenate oils. pulp/paper. 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. However. The materials and fluids used in some processes can be hazardous in the sense that they can ignite or explode. 169 . combustible fuels. including agriculture. retail. leaks.
and maintained in accordance with practices that are appropriate for the hazard.calibration in hazardous environments selected. Temperature classes limit the maximum surface temperature between 450˚C (T1) and 85˚C (T6). and the protection concept applied. In general. ib Flammable material present abnormally In addition. 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. Equipment requirements in hazardous locations Protection requirements for hazardous locations vary according to the type of material present. 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. Adding the applicability of IS designs to various hazards in the previous table yields: Zone 0 ia Flammable material present continuously Zone 1 ia. 170 . ib Flammable material present intermittently Zone 2 ia. frequency of the hazard. 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 intensity with which various vapors can combust is generally different. a hot surface temperature on a device can cause ignition. installed.
The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work. and other variables designed in hazardous locations are generally used to monitor and control the process. As such. voltage. level. they can be used for the overwhelming majority of applications where a vapor hazard is present. In some applications. The Beamex multifunction IS-calibrators are portable and intrinsically safe and have modules that can accommodate wide ranges and many types of pressure. 171 . which means that many instruments are calibrated in the field. This is usually not the case. it is practical to remove these instruments and calibrate them on the workshop with a calibration test bench. and tracks calibration history. This software generally makes calibration work faster and easier and is designed to integrate into management systems such as SAP and Maximo. there are calibrators that are specifically designed to operate safely in rugged environments and hazardous locations. and frequency measurements. thermocouple. temperature. pressure. but also automatically takes data. The Beamex modular calibration system is a test bench and calibration system for workshops and laboratories that incorporates the functionality of the MC5 multifunction calibrator and can measure/generate additional parameters such as precision pressures. The ergonomic design and modular construction allow the user to select the necessary functions in a cost-effective manner. creates documentation. pulse. current. adheres to GMP regulations (21 CFR 11). It not only alerts you when to calibrate.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. RTD. The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work. Fortunately.
• Portable Beamex calibrators for hazardous locations are designed to be used in virtually all vapor hazards. • Hazardous locations can exist in virtually all industries. and in the home. • Instruments should be specified. 172 . and in the home. and maintained in accordance with requirements for the hazardous location. operated. stores.calibration in hazardous environments A few points to remember • Improper actions in hazardous locations can result in property damage and bodily injury. stores. installed. Hazardous locations can exist in virtually all industries.
calibration in hazardous environments 173 .
gas Hazardous area classifications in IEC/ European countries are: Zone 0: an explosive gas & air mixture is continuously present or present for a long time. “calibrators for Ex Areas”.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. mists. and if it occurs it will exist only for a short time. 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. such as gases. intrinsically safe fieldbus calibrators enter into the picture. There are also industrial environments where the calibration of fieldbus instruments should not only be made accurately and efficiently. or “IS calibrators”. intrinsic safety (IS) is a protection technique for safely operating electronic equipment in explosive environments. When safety becomes a top priority issue in calibration. 175 . 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. By definition. Zone 2: an explosive gas & air mixture is not likely to occur in normal operation. Intrinsically safe calibrators are designed for potentially explosive environments. Zone 1: an explosive gas & air mixture is likely to occur in normal operation. vapors or combustible dust. Intrinsically safe calibrators are also often referred to being “Ex calibrators”. The concept has been developed for safely operating process control instrumentation in hazardous areas. A hazardous atmosphere is an area that contains elements that may cause an explosion: source of ignition. Where is intrinsically safe calibration required? Many industries require intrinsically safe calibration equipment. rigs and processing plants. An intrinsically safe calibrator is therefore designed to be incapable of causing ignition in the surrounding environment with flammable materials. such as oil refineries. but also safely. a flammable substance and oxygen.
petrochemical and chemical plants. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. it is the safest possible technique. the calibrators provide performance and functionality. Safest possible technique Intrinsically safe calibrators are safe for employees. In view of safety. First of all. temperature and electrical signals. The product safety note lists all the “do’s and don’ts” for safe calibration. Performance and functionality Multifunctional intrinsically safe calibrators provide the functionality and performance of regular industrial calibration devices. 176 . there are also some guidelines and constraints for how to use them in hazardous areas. as well as pharmaceutical plants. such as the Beamex® MC5.the safest way to calibrate fieldbus instruments pipelines and distribution centres. Secondly. which should be read carefully before using the device. This eliminates the need of manual recording of calibration data and improves the quality and productivity of the entire calibration process. What are the benefits of using intrinsically safe calibrators? There are clear benefits in using intrinsically safe calibration equipment. Basically. as they can be safely used in environments where the risk of an explosion exists. Every intrinsically safe calibrator is delivered with a product safety note. 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). 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. They can be used for calibration of pressure. In addition. but in a safe way. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. Basically. A documenting intrinsically safe calibrator. provides additional efficiency improvements with its seamless communication with calibration software.IS.
When charging the battery. it must be done in a non-Ex area. Companies in the EU where the risk of explosion is evident must also use the ATEX guidelines for protecting the employees. The battery of an intrinsically safe calibrator is usually slower to charge and it discharges quicker. maximum is lower) • Battery slower to charge. 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. External pressure modules can be used with IS-calibrators. 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. explosive atmospheres in French) is a standard set in the European Union for explosion protection in the industry. In addition. IECEx is an international scheme for certifying procedures for equipment designed for use in explosive atmospheres. ATEX 95 equipment directive 94/9/EC concerns equipment intended for use in potentially explosive areas.g.g. 2003. 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. while maintaining the required level of safety.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. . but the Beamex intrinsically safe calibrators operate with chargeable batteries. they must be IS-versions What are ATEX and IECEx? ATEX (“ATmosphères EXplosibles”. Many times intrinsically safe equipment operate only with dry 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. The surface of the device is made of conductive material. The objective of the IECEx Scheme is to facilitate international trade in equipment and services for use in explosive atmospheres. quicker to discharge • Battery must be charged in a non-Ex area • When using external pressure modules. There are also usually small differences with electrical ranges compared to regular industrial calibrators (e. maximum is lower). but they must also be intrinsically safe.
The MC5-IS has calibration capabilities for pressure. which means that it communicates seamlessly with calibration software. Using documenting calibrators with calibration software can remarkably improve the efficiency and quality of the entire calibration process. Safe fieldbus calibration with the Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator The Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is a high accuracy. temperature. The MC5-IS is also ATEX and IECEx certified. The best way to do this is to send it to the manufacturer or to an authorized service company for repair. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. 178 . electrical and frequency signals. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. It is a documenting calibrator. The MC5-IS also has HART communication. The MC5-IS can also be used for calibrating Foundation Fieldbus H1 or Profibus PA transmitters. Being an all-in-one calibrator. the MC5-IS replaces many individual measurement devices and calibrators. 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. Recalibration can be done by calibration laboratories (still preferably with ISO/IEC 17025 accreditation). all-in-one calibrator for extreme environments. The MC5-IS also has HART communication. 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.the safest way to calibrate fieldbus instruments As Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is certified according to ATEX and the IECEx Scheme.
Jay L. In technical work. scientific and engineering work (such as metrology) it is important to correctly use words that have a technical meaning. not to standardize the way the words should be used. 181 . In technical. It is a supplement to the VIM. the purpose of common dictionaries is to record the ways that people actually use words. Definitions of these words are in relevant national. and the information in the other references listed at the end. only the technical definitions should be used. Milwaukee: ASQ Quality Press. NCSL Glossary. its definition from a common grammar dictionary should never be used in work where the technical standard can apply. ______________ 1. as well as publications of relevant technical and professional organizations. 2004. The Metrology Handbook. If a word is defined in a technical standard. However. Bucher. In some cases several may be merged to better clarify the meaning or adapt the wording to common metrology usage. journals.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. international and industry standards. GUM. Many of these definitions are adapted from the references. Those documents give the intended meaning of the word. The technical definitions may be different from the definitions published in common grammar dictionaries. and other publications. so everyone in the business knows what it is.
3. NCSL. 2nd ed. Geneva: ISO. IUPAC. and OIML. ANSI/NCSL Z540-2-1997. ISO. IFCC. 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. Some terms may be listed in this glossary in order to expand on the definition. accuracy of a measurement is always 182 . International vocabulary of basic and general terms in metrology (called the VIM). (VIM. 1999. Guide to the expression of uncertainty in measurement (called the GUM). NCSL Glossary of metrology-related terms. Boulder. but should be considered an addition to the references listed above. 2. CO: NCSL International. not a replacement of them. Boulder. Accreditation criteria – Set of requirements used by an accrediting body that a laboratory must meet in order to be accredited. The certificate. CO: NCSL International. (It is assumed that a calibration or metrology activity owns copies of these as part of its basic reference material. BIPM. Accreditation includes evaluation of both the quality management system and the competence to perform the measurements listed in the scope. 3. Accreditation certificate – Document issued by an accreditation body to a laboratory that has met the conditions and criteria for accreditation. S. IEC. ISO. ANSI/NCSL. IUPAP. Accreditation body – An organization that conducts laboratory accreditation evaluations in conformance to ISO Guide 58.5) Because the true value is always unknown. U. with the documented measurement parameters and their best uncertainties. serves as proof of accredited status for the time period listed. 1997. An accreditation certificate without the documented parameters is incomplete.) 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.appendix: calibration terminology a to z 1 Terms that are not in this glossary may be found in one of these primary references: 1. 1993.
realize.) Calibration is a term that has many different – but similar – definitions. 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.appendix: calibration terminology a to z 1 an estimate. Calibration is performed with the item being calibrated in 183 .18) Accuracy is a design specification and may be verified during calibration. Adding a correction. which is always the negative of the bias. 5. (VIM. Contrast with: accuracy (of a measuring instrument) Accuracy (of a measuring instrument) – Accuracy is a qualitative indication of the ability of a measuring instrument to give responses close to the true value of the parameter being measured. (VIM.25) The value and direction of the bias is determined by calibration and/or gage R&R studies. It is the process of verifying the capability and performance of an item of measuring and test equipment by comparison to traceable measurement standards. Bespoke/Customized computerised system – A computerised system individually designed to suit a specific business process Best measurement capability – For an accredited laboratory. 5. or when performing more-or-less routine calibrations of nearly ideal measuring instruments designed for the measurement of that quantity. 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 reproduce a unit of that quantity or one or more of its values.” (EA-4/02) The best measurement capability is based on evaluations of actual measurements using generally accepted methods of evaluating measurement uncertainty. conserve. It has quantitative value only when accompanied by information about the uncertainty of the measuring system. See also: correction. An accuracy statement by itself has no meaning other than as an indicator of quality. systematic error Calibration – (1).11 and NCSL pages 4–5 for primary and secondary definitions. Bias – Bias is the known systematic error of a measuring instrument. compensates for the bias. (See VIM 6.
or minimize by adjustment any deviations from the tolerance limits or any other variation in the accuracy of the instrument being compared.appendix: calibration terminology a to z 1 its normal operating configuration – as the normal operator would use it. may be included as part of the calibration. to a measurement system or device of specified capability and known uncertainty in order to detect. Calibration is performed according to a specified documented calibration procedure. The calibration process uses traceable external stimuli. or artifacts as needed to verify the performance. or is otherwise in an indeterminate state. or minor adjustment such as zero and span. measurement standards. The calibration process consists of comparing an IM&TE unit with specified tolerances. 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. and with a specified and controlled measurement system. under a set of specified and controlled measurement conditions. or the determination of one or more corrections. fuses. Calibration provides assurance that the instrument is capable of making measurements to its performance specification when it is correctly used. This may be in the form of a pass/fail decision. determining or assigning one or more values. report. • The calibration process may include. 184 . See also: performance test. but of unverified accuracy. if necessary. 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. • In some cases. calculation of correction factors or adjustment of the instrument being compared to reduce the magnitude of the inaccuracy. or lamps. • Calibration does not include any maintenance or repair actions except as just noted. minor repair such as replacement of batteries. Notes: • A requirement for calibration does not imply that the item being calibrated can or should be adjusted. The result of a calibration is a determination of the performance quality of the instrument with respect to the desired specifications.
standardization Calibration activity or provider – A laboratory or facility – including personnel – that perform calibrations in an established location or at customer location(s). When used this way.appendix: calibration terminology a to z 1 is known to be out of tolerance. calibration means the same as alignment or adjustment. These and similar tasks are excluded from the metrological definition of calibration. A calibration certificate should provide other information to allow the user to judge the adequacy and quality of the calibration. The certificate identifies the item calibrated. A calibration procedure documents one method of verifying the actual performance of the item being calibrated against its performance specifications. (B) In many cases. or tolerances for a model of measuring or testing equipment. specifications. if it is amended later a new certificate is created. and the effective date. (2) In a laboratory database program. It may be external or internal. or department. a certificate often refers to the permanent record of the final result of a calibration. including subsidiary operations of a larger entity. or after it is repaired. which are repair activities and excluded from the metrological definition of calibration. or any combination or variation of these. 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. A laboratory database certificate is a record that cannot be changed. or an industry-specific name. Examples include performing a selftest as part of normal operation or performing a self-calibration (normalizing) a measurement system before use. IM&TE instruction manuals may use calibration to describe tasks normally performed by the operator of a measurement system. Contrast with: calibration (1) See also: normalization. self-calibration. Calibration certificate – (1) A calibration certificate is generally a document that states that a specific item was calibrated by an organization. the organization presenting the certificate. the intent is that they are part of the normal work done by a trained user of the system. shop. a means to record 185 . It provides a list of recommended calibration standards to use for the calibration. It may be called a calibration laboratory. When calibration is used to refer to tasks like this. a metrology laboratory or department.
they are more closely controlled and characterized than the workload items they are used for. 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. Note: A calibration seal may also be referred to as a tamper seal. and NCSL pages 36–38. Calibration report – A calibration report is a document that provides details of the calibration of an item. Calibration standards generally have lower uncertainty and better resolution than general-purpose items. A calibration program may also be called a measurement management system (ISO 10012:2003). Note: A calibration procedure does not include any maintenance or repair actions.14. and the process of calibrating IM&TE used to determine conformance to requirements or used in supporting activities.1 through 6. Calibration program – A calibration program is a process of the quality management system that includes management of the use and control of calibrated inspection.13. As calibration standards are used to calibrate other IM&TE items.9. In addition to the basic items of a calibration certificate. 6. The purpose of a calibration seal is to ensure the integrity of the calibration. or measurement transfer standard that is designated as being used only to perform calibrations of other IM&TE 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. clearly indicates tampering. or label that. placard. when removed or tampered with. and the actual measurement results and uncertainty. 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. standard reference material. and test and measuring equipment (IM&TE). and 6. artifact. Calibration standard – (See VIM. 6.appendix: calibration terminology a to z 1 quantitative performance data both before and after adjustments. a calibration report includes details of the methods and standards used. the parameters checked. Designation as a 186 . See also: calibration certificate Calibration seal – A calibration seal is a device. and by virtue of its design and material. and information sufficient to determine if the unit being calibrated is operating within the necessary performance specifications.) A calibration standard is an IM&TE item.
The terms are the variances or covariances of these other quantities. s is the sample standard deviation. weighted according to how the measurement result varies with changes in those quantities. and t is the Student’s T value for α ⁄2 and (n – 1) (α is the level of significance). x is the sample mean. p is the proportion of items of a given type in the population. Calibration standards are often called measurement standards. It is equal to the positive square root of a sum of terms. since it is a synonym and has more accepted usage in the United States. n is the number of items in the sample. For an infinite (or very large compared to the sample) population. the demonstrated ability to apply knowledge and skills. lines.appendix: calibration terminology a to z 1 calibration standard is based on the use of the specific instrument. Competence – For a laboratory. 2.4) See also: expanded uncertainty Commercial of the shelf software – Software commercially available. not on any other consideration. The confidence interval is calculated from sample statistics. one might be designated as a calibration standard while the others are all general purpose IM&TE items. in a group of identical instruments. when that result is obtained from the values of a number of other quantities. Note: The word qualification is sometimes used in the personal sense. slopes. Confidence intervals can be calculated for points. 187 .3. standard deviations. whose fitness for use is demonstrated by a broad spectrum of users. For example. 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. For a person. (GUM. the confidence interval is: p (1 – p) s CI = x ¯ ± t = ––– or CI = p ± ––––––––– n n where CI is the confidence interval. however. and so on. See also: standard (measurement) Combined standard uncertainty – The standard uncertainty of the result of a measurement. the demonstrated ability to perform the tests or calibrations within the accreditation scope and to meet other criteria established by the accreditation body.
which approximately corresponds to a probability of 95 percent for degrees of freedom > 10’. The exact meaning can usually be determined from examination of the calibration certificate. error. It is usually given the value 2. Equivalence – (A) Acceptance of the competence of other national metrology institutes (NMI).6) The coverage factor is identified by the symbol k. Deficiency – Nonfulfillment of conditions and/or criteria for accreditation. accreditation body.15) Any residual amount is treated as random error. (VIM. systematic error Corrective action – Corrective action is something done to correct a nonconformance when it arises. and/or accredited organizations within the host country. sometimes referred to as a nonconformance. 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. 2. and NCSL pages 11–13. 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. (GUM. 3. See also: bias. The correction value is equal to the negative of the bias. accreditation bodies. for a particular application. The error can never be known exactly. it is always an estimate. documented determination that a specific instrument or type of instrument is suitable for use in place of the one originally listed. (B) A formal. 3.14. and/or accredited organizations in other countries as being essentially equal to the NMI.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. which 188 .3. random error. Systematic error (also known as bias) may be corrected. including actions taken to prevent reoccurrence of the nonconformance. 3. 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.10. Error (of measurement) – (See VIM. Error may be systematic and/or random. error or systematic error. Departure value – A term used by a few calibration laboratories to refer to bias.) In metrology. correction (of error). random error. See also: bias.12–3. systematic error Gage R&R – Gage repeatability and reproducibility study.
performance. PMET (precision measuring equipment and tooling). PME (precision measuring equipment). measurements. and evaluation of tests or calibrations on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions. measuring. 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. Some organizations do not include instruments used solely to check for the presence or absence of a condition (such as voltage. personnel. and measurements over a period of time to capture quantitative observations.appendix: calibration terminology a to z 1 (typically) employs numerous instruments. 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. An internal audit is done by or on behalf of the laboratory itself. The number of instruments. the equivalent document is ANSI/NCSL Z540-2-1997. pressure. The mission of ISO is “to promote the development of standardization and 189 . The data captured are analyzed statistically to obtain best measurement capability. and test equipment. IM&TE – The acronym IM&TE refers to inspection. International Organization for Standardization (ISO) – An international nongovernmental organization chartered by the United Nations in 1947. This term includes all items that fall under a calibration or measurement management program. personnel. Note: Organizations may refer to IM&TE items as MTE (measuring and testing equipment). and diagnostic equipment). or after a process. which is expressed as an uncertainty with a coverage factor of k = 2 to approximate 95 percent. U. measuring. Switzerland. during. or SPETE (special purpose electronic test equipment). S. In the United States. GUM – An acronym commonly used to identify the ISO Guide to the Expression of Uncertainty in Measurement. and so on) where a tolerance is not specified and the indication is not critical to safety. Interlaboratory comparison – Organization. IM&TE items are typically used in applications where the measurement results are used to determine conformance to technical or quality requirements before. TMDE (test. with headquarters in Geneva. so it is a first-party audit.
(The acronym SI is from the French Systéme International.appendix: calibration terminology a to z 1 related activities in the world with a view to facilitating the international exchange of goods and services.) See also: ISO International System of Units (SI) – A defined and coherent system of units adopted and used by international treaties. industry and commerce except electrical and electronic engineering. it would be different in each language. (The United States is represented by ANSI. amount of substance. The members of ISO are the designated national standards bodies of each country. ISO – Iso is a Greek word root meaning equal. ISO is not an acronym. (VIM. the coverage level expressed as a percent. time.) The name also symbolizes the mission of the organization – to equalize standards worldwide. France. testing. Measurement – A set of operations performed for the purpose of determining the value of a quantity. operation. The International Organization for Standardization chose the word as the short form of the name. electric current.) SI is international system of measurement for all physical quantities.1) 190 . installation. specification. (If the acronym was based on the full name were used. 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. 2. technological and economic activity. 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. and p is the coverage probability or level of confidence of the interval. which makes it possible for the application to function. and to developing cooperation in the spheres of intellectual.” The scope of ISO’s work covers all fields of business. The SI system is popularly known as the metric system. periodic.) SI units are defined and maintained by the International Bureau of Weights and Measures (BIPM) in Paris. programming. IT Infrastructure – The hardware and software such as networking software and operation systems. and maintenance. Effectively. scientific. (Mass. so it will be a constant in all languages. Management review – The planned. and luminous intensity. thermodynamic temperature. In this context. Life cycle – All phases in the life of the system from initial requirements until retirement including design. formal. length.
Mobile operations – Operations that are independent of an established calibration laboratory facility. The measurement system includes at least the test and measuring instruments and devices. conditions. Natural (physical) constant – A natural constant is a fundamental value that is accepted by the scientific community as valid. Natural constants are used in the basic theoretical descriptions of the universe. and test and measurement. and the base of natural logarithms (e). measurement standards. education. or the use of a virtual office. NCSL promotes technical and managerial excellence in the field of metrology. the procedures used. For example. scientific. and other quantifiable factors that combine to determine the success of a measurement process. the gravitational constant (G).appendix: calibration terminology a to z 1 Measurement system – A measurement system is the set of equipment. if the thermocouple alloy leads of a reference junction probe are formed into a measurement junction and placed in an ice point cell. development. vehicle. associated materials and accessories. NCSL has member organizations from academic. then the theoretical thermoelectric emf measured at the copper wires should be zero. the triple point of water (273. instrument calibration. industrial. NCSL international – Formerly known as the National Conference of Standards Laboratories (NCSL). people. or commerce. commercial and government facilities around the world.2).16 K). 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. the ratio of a circle’s circumference to its diameter (p).” Normalization. NCSL is a nonprofit organization. and the physical environment. home. Examples of natural physical constants important in metrology are the speed of light in a vacuum (c). 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 quantum charge ratio (h/e). the personnel. Metrolog y – Metrology is the science and practice of measurement (VIM. methods. and the reference junction itself is also in the ice point. Any value other than zero is an offset created by inhomogeneity of the thermocouple wires combined 191 . 2. whose membership is open to any organization with an interest in the science of measurement and its application in research.
(NCSL. Calibration: see calibration procedure. Some policies may be implemented by fairly detailed procedures. (VIM. There may be more than one procedure for a given policy.5) Preventive action – Preventive action is something done to prevent the possible future occurrence of a nonconformance. 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. A performance test is done with the item in its normal operating configuration.appendix: calibration terminology a to z 1 with other uncertainties. 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. Preventive action helps improve the system. Compare with: bias. A performance test is the same as a calibration (1). This includes climate-controlled mobile laboratories. page 26) Precision is not the same as accuracy. Policy statements relevant to the quality management system are generally stated in the quality manual. but actually perform the calibration actions at customer locations. A policy describes what management intends to have done regarding a given portion of business activity. A procedure has more detail than a policy but less detail than a work instruction. 3. Policies can also be in the organization’s policy/procedure manual. See also: procedure Precision – Precision is a property of a measuring system or instrument. Contrast with: corrective action Procedure – A procedure describes a specific process for implementing all or a portion of a policy. while others may only have a few general guidelines. vision. 192 . See also: policy Process owner – The person responsible for the business process. goals. error On-site operations – Operations that are based in or directly supported by an established calibration laboratory facility. See also: calibration (1) Policy – A policy defines and sets out the basic objectives. or general management position on a specific topic. even though such an event has not yet happened. 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.
3. auditors use the quality manual when they audit the quality management system. but Type B methods are also used in some situations. Repair includes adjustment or alignment of the item as well as component-level repair. repair (minor) Repair (minor) – Minor repair is the process of quickly and economically returning an unserviceable item to serviceable condition by doing simple work using parts that are in stock in the calibration lab. The quality manual briefly defines the general policies as they apply to the specified conformance standard and affirms the commitment of the organization’s top management to the policy.) The need for repair may be indicated by the results of a calibration.appendix: calibration terminology a to z 1 Proficiency testing – Determination of laboratory testing performance by means of interlaboratory comparisons. The need for repair may be indicated by the results of a calibration. or lamps. Therefore. or proprietary information. Passing the calibration test indicates success of the repair. or repairing a broken wire. or minor cleaning of switch contacts. minor repair is always followed by calibration of the item. or replacing one or two in-stock components. For calibratable items. it does not usually contain any detailed policies and never contains any procedures. therefore. repair is always followed by calibration of the item.13) Random error causes scatter in the results of a sequence of readings and. Random error – Random error is the result of a single measurement of a value. (VIM. the GUM specifically does not replace random error with either Type A or Type B methods of evaluation. (Some minor adjustment such as zero and span may be included as part of the calibration. See also: error Compare with: systematic error Repair – Repair is the process of returning an unserviceable or nonconforming item to serviceable condition. For calibratable items. Note: Contrary to popular belief. Examples include replacement of batteries. Quality manual – The quality manual is the document that describes the quality management policy of an organization with respect to a specified conformance standard. work instructions. is a measure of dispersion. fuses. or is removed from its case and may be disassembled to some degree. Random error is usually evaluated by Type A methods. Passing 193 . minus the mean of a large number of measurements of the same value. Contrast with: calibration (1). The instrument is opened. In addition to its regular use by the organization. The quality manual is generally provided to customers on request. or has covers removed.
repair Reported value – One or more numerical results of a calibration process. with the associated measurement uncertainty. The uncertainty is usually expanded uncertainty as defined in the GUM. specific measurements. or calibrations and their best measurement. 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. parameters.appendix: calibration terminology a to z 1 the calibration test indicates success of the repair. and only the listed areas may be offered as accredited calibrations or tests. or week of continuous operation. Round robin – See: Interlaboratory Comparison Scope of accreditation – For an accredited calibration or testing laboratory. day. Contrast with: calibration (1). In general. • Estimated systematic error and uncertainty. most reported values will be in one of these formats: • Measurement result and uncertainty. Minor repairs are defined as repairs that take no longer than a short time as defined by laboratory management. The specific type and format vary according to the type of measurement being made. and where no parts have to be ordered from external suppliers. Only the calibration or testing areas that the laboratory is accredited for are listed in the scope document. as recorded on a calibration report or certificate. The scope document is an attachment to the certificate of accreditation and the certificate is incomplete without it. 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 uncertainty of the deviation is usually expanded uncertainty as defined in the GUM. and where substantial disassembly of the instrument is not required. or once per shift. The accreditation body usually defines the format and other details. uncertainty. The process may be required at intervals such as every power-on sequence. 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 . The reported value is usually the mean of a number of repeat measurements. the scope is a documented list of calibration or testing fields.
calibration standard. device.B) Contrast with: calibration (1) Specification – In metrology. instrument. Selfcalibration may also be called normalization or standardization. laboratory standard. The usual purpose is accuracy enhancement by characterization of errors inherent in the measurement system before the item to be measured is connected. Standard (document) – A standard (industry. a specification is a documented statement of the expected performance capabilities of a large group of substantially identical measuring instruments. national. A product that performs outside the specification limits when tested (calibrated) is rejected for later adjustment.appendix: calibration terminology a to z 1 amount. the process may be performed totally by the instrument or may require user intervention and/or use of external calibrated artifacts. Standard (measurement) – A standard (measurement standard. reference standard. a national standard that describes the requirements for the quality management system of a calibration organization and the requirements for calibration and management of the measurement standards used by the organization. Primary standard. or international standard. 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. artifact. Compare with: calibration (2. or the methods for evaluation of any of these. Customers use specifications to determine the suitability of a product for their own applications. then that will also be accomplished at the start of a calibration procedure. or material that is used as a defined basis for making quantitative measurements. an étalon) is a system. Also. or scrapping. Accepted as having the highest metrological 195 . repair. 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. 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. An example is ANSI/NCSL Z540-11994. if an instrument requires self-calibration before use. given in terms of the relevant parameters and including the accuracy or uncertainty. government. 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. Once initiated.
Note: Contrary to popular belief. 2. or traceable to. (VIM. Systematic error is also called bias when it applies to a measuring instrument. A device used to transfer the value of a measurement quantity (including the associated uncertainty) from a higher level to a lower level standard. SRMs represent one of the primary vehicles for disseminating measurement technology to industry. are the realizations or representations of SI units.1) Standardization – See: self-calibration. 3. See also: calibration standard Standard operating procedure (SOP) – A term used by some organizations to identify policies. and is accompanied by.3. or work instructions. expressed as a standard deviation. a certificate or other documentation which is issued by NIST… Standard reference materials are…manufactured according to strict specifications and certified by NIST for one or more quantities of interest. (3. procedures. correction (of error) Compare with: random error 196 . Secondary standard. A standard that is used for routine calibration of IM&TE. The highest level standards.” Standard uncertainty – The uncertainty of the result of a measurement. Transfer standard. Also called a reference standard. The highest accuracy level standards in a particular laboratory generally used only to calibrate working standards. 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. Working standard. found in national and international metrology laboratories. Systematic error may be evaluated by Type A or Type B methods. (GUM. Systematic error is a measure of magnitude and may be corrected. 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. note) See also: bias.3.appendix: calibration terminology a to z 1 qualities and whose value is accepted without reference to other standards of the same quantity.14) Systematic error causes the average of the readings to be offset from the true value. Examples: triple point of water cell and caesium beam frequency standard. error. the GUM specifically does not replace systematic error with either Type A or Type B methods of evaluation.2. according to the type of data available.
it represents the maximum allowable deviation from a specified value. uncertainty 197 . Test accuracy ratio – (1) In a calibration procedure. Test uncertainty ratio – In a calibration procedure. If the accuracy tolerances are expressed as decibels. 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. Note: TAR may also be referred to as the accuracy ratio or (incorrectly) the uncertainty ratio. percentage. page 2) TAR = UUT_tolerance STD_tolerance The TAR must be calculated using identical parameters and units for the UUC and the calibration standard. If the accuracy tolerances are expressed as decibels. 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. page 2) TUR = UUT_tolerance STD_uncert The TUR must be calculated using identical parameters and units for the UUC and the calibration standard. they must be converted to absolute values of the basic measurement units. A tolerance is a property of the item being measured. the TAR is the ratio of the tolerance of the parameter being measured to the accuracy tolerance of the IM&TE. or another ratio. and maintenance of a computerised system and for the security of the data residing on that system. percentage. or another ratio. Tolerances are applied during design and manufacturing. (NCSL.appendix: calibration terminology a to z 1 System owner – The person responsible for the availability. they must be converted to absolute values of the basic measurement units. Note: The uncertainty of a measurement standard is not necessarily the same as its accuracy specification. (NCSL. 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. (2) In the normal use of IM&TE items. Compare with: specification.
Examples of typical transfer standards are DC volt sources (standard cells or zener sources). or from a secondary standard to a working standard in order to create or maintain measurement traceability. 6. a calibrated IM&TE. Transfer standard – A transfer standard is a measurement standard used as an intermediate device when comparing two other standards.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. Common transfer methods are differential measurements and ratio measurements. Only the result of a specific measurement can be said to be traceable. A calibration system operating under a program controls system only implies 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. from a primary standard to a secondary 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. ratio type comparisons. (NCSL. A calibration laboratory. provided all of the conditions just listed are met. pages 42–43) The stated references are normally the base or supplemental SI units as maintained by a national metrology institute. or inductors. and singlevalue standard resistors. but the report alone is not sufficient. fundamental or physical natural constants that are reproducible and have defined values. a measurement system. a calibration report. 6. Evidence of traceability includes the calibration report (with values and uncertainty) of calibration standards. The laboratory must also apply and use the data. through an unbroken chain of comparisons each having stated uncertainties. (VIM. Traceability provides the ability to demonstrate the accuracy of a measurement result in terms of the stated reference.appendix: calibration terminology a to z 1 Traceable. Measurement assurance methods applied to a calibration system include demonstration of traceability. (VIM. 198 . certified standard reference materials. or industry or other accepted consensus reference 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. traceability – Traceability is a property of the result of a measurement. capacitors. Reference to a NIST test number is specifically not evidence of traceability.8) Typical applications of transfer standards are to transfer a measurement parameter from one organization to another.
(GUM. 2. 3.5) Uncertainty can only be evaluated by Type A methods if the laboratory actually collects the data. 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 A methods. 3.3 through 3. methods.3.3 through 3. UUT – The unit under calibration or the unit under test – the instrument being calibrated.3) Uncertainty is an estimate of the range of values that the true value of the measurement is within. Uncertainty is an estimate of dispersion. Validation – Substantiation by examination and provision of objective evidence that verified processes. Also may be called device under test (DUT) or equipment under test (EUT). and/or procedures are fit for their intended use.3.2.3. After an item that has a specified tolerance has been calibrated using an instrument with a known accuracy. with a specified level of confidence. Both random and systematic error may be evaluated by Type B methods. Verification – Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.5) Data for evaluation by Type B methods may come from any source believed to be valid. These are standard generic labels for the IM&TE item that is being calibrated. See also: Type A evaluation. Uncertainty – Uncertainty is a property of a measurement result that defines the range of probable values of the measurand. VIM – An acronym commonly used to identify the ISO International 199 . Type B evaluation (of uncertainty) – Type B evaluation of measurement uncertainty includes any method except statistical analysis of actual measurement results. (GUM. UUC. and/ or other applicable measurement criteria. effects that contribute to the dispersion may be random or systematic. the result is a value with a calculated uncertainty. range of measurement. categorized by type of measurement. Type B evaluation Uncertainty budget – The systematic description of known uncertainties relevant to specific measurements or types of measurements.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. (GUM.3. which are used in the text of the calibration procedure for convenience.
In a metrology laboratory. 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. 2004. Milwaukee: ASQ Quality Press. a calibration procedure is a type of work instruction. Work instructions are used only where they are needed to ensure the quality of the product or service. (The acronym comes from the French title. 1. a work instruction defines the detailed steps necessary to carry out a procedure. The Metrology Handbook.appendix: calibration terminology a to z 1 Vocabulary of Basic and General Terms in Metrology.) Work Instruction – In a quality management system. Bucher. 200 . Jay L.
PORTABLE CALIBRATORS WORKSTATIONS PROFESSIONAL SERVICES CALIBRATION SOFTWARE 202 .
nuclear. calibration software. workstations. pharmaceutical. marine. oil and gas.about beamex About Beamex • One of the world’s leading providers of calibration solutions. manufacturing. systems and services for the calibration and maintenance of process instruments. Integrated calibration solutions Beamex calibrators. (IAF). calibration software and professional services form an integrated. accredited calibration certificate. validation. European co-operation for Accreditation (EA). metal and mining. Industry pioneer with global presence A forerunner in developing high-quality calibration equipment and software. • Beamex’s Accredited Calibration Laboratory is accredited and approved by FINAS (Finnish Accreditation Service). power and energy.e. FINAS is a member of all Multilateral Recognition Agreements / Mutual Recognition Arrangements (MLA/MRA) signed by European and other international organizations. • Customers from wide range of industries. workstations. aviation. ease-of-use and reliability. automated system. such as automotive. High customer satisfaction Constantly improving understanding of customer needs and developing solutions to meet them. education. International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum Inc. petrochemical and chemical. system integration. versatility. Help Desk and re-calibration services available. contractor engineering.000 companies worldwide utilize Beamex’s calibration solutions. training. 203 . food and beverage. • Products and services available in more than 60 countries. • Comprehensive product range includes portable calibrators. software. database conversion. accessories. They are all delivered with a traceable. i. efficiency. professional services and industryspecific solutions. • For customers with requirements for accuracy. More than 10. and pulp and paper. with global customer base and partner network. Why is Beamex better Accuracy assured Accuracy is assured when you decide to purchase a Beamex® calibrator. • Develops and manufactures high-quality calibration equipment. • Certified in accordance with the ISO 9001:2008 quality standard. Support Installation.