Ultimate Calibration 2nd Edition

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 info@beamex.com. Beamex is a trademark of Beamex Oy Ab. All other trademarks or trade names mentioned in this book are the property of their respective holders.

Graphic design: Studio PAP Photos: Mats Sandström and image bank Printed by: Fram in Vaasa 2012, Finland

REGULATIONS AND TRACEABILITY Quality standards and industry regulations  11 A basic quality calibration program  35 Traceable and efficient calibrations in the process industry  57 CALIBRATION MANAGEMENT AND MAINTENANCE Why Calibrate? What is the risk of not calibrating?  73 Why use software for calibration management?  79 How often should instruments be calibrated?  89 How often should calibrators be calibrated?  97 Paperless calibration improves quality and cuts costs  101 Intelligent commissioning  107 Successfully executing a system integration project  115 CALIBRATION IN INDUSTRIAL APPLICATIONS The benefits of using a documenting calibrator  125 Calibration of weighing instruments Part 1  131 Calibration of weighing instruments Part 2  137 Calibrating temperature instruments  143 Calculating total uncertainty of temperature calibration with a dry block  149 Fieldbus transmitters must also be calibrated  157 Configuring and calibrating smart instruments  163 Calibration in hazardous environments  169 The safest way to calibrate to calibrate Fieldbus instruments  175 APPENDIX:  Calibration terminology A to Z  181 .Contents Preface by the CEO of Beamex Group  7 QUALITY.

foreword 6 .

how to eliminate double work. calibration procedures need to be automated to a higher degree and integrated to achieve improvements in quality and efficiency. ceo. All of these challenges can be tackled by improving the level of system integration and automation. and how to lower the risk of human errors. Presently. Enjoy your reading! raimo ahola. In this area. new ideas. the primary challenges of industrial metrology and calibration include how to simplify and streamline the entire calibration process. and calibration of smart instruments. how to reduce production down-time. On behalf of Beamex. systems or work processes within a company or production plant. temperature calibration and configuring. 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. Beamex aims to be the benchmark in the industry. The new topics covered in the edition mainly discuss paperless calibration. This book is the 2nd edition of Ultimate Calibration. This book is the result of work that has taken place between 2006 and 2012. I want to express my special thanks to Pamela at Beamex Marketing.preface by the ceo of beamex group Preface C alibrators. A team of experts in industry and calibration worldwide has put forth effort to its creation. beamex group 7 . Calibration and calibrators can no longer be considered as isolated. stand-alone devices. who was the key person in organizing and leading the project for the 2nd edition. 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. Just like any other business function. I hope this book will assist you in learning new things and in providing fresh. I would like to thank all of the people who have contributed to this book. intelligent commissioning.

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Regulations and Traceability .Quality.

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the computer. but you have scarcely.A. beer. and the clerk of the scales. in your thoughts. thus confused by false appearance. and a standard width of dyed russet and cloth. PC. but reason. Surely it is the better part of thought that relies on measurement and calculation. (Clause 35.K.C. Magna Carta. The Republic. 1215) When you can measure what you are speaking about and express it in numbers. numbering and weighing. but when you cannot express it in numbers. is beautifully restored by measuring. these drive vague notions of greater or less or more or heavier right out of the minds of the surveyor. PRS. 26 June 1824–17 December 1907. you know something about it. 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 ..) There shall be standard measures of wine.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. (William Thomson.C. The Egyptians studied the science of geometry to assist them in the construction of the Pyramids. your knowledge is of a meager and unsatisfactory kind. It may be the beginning of knowledge. and corn… throughout the whole of our kingdom. the Egyptian unit of length came into being. GCVO. Lord Kelvin). OM. here is a reminder from times past about measurement practices and how important they really are. A. It is believed that about 3000 years B. 360 B. (Plato.1 One of the earliest records of precise measurement is from Egypt. Immersion in water makes the straight seem bent. and there shall be standard weights also. advanced to the stage of science. 1st Baron Kelvin.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) aims to improve harmonisation of Good Manufacturing Practice (GMP) standards and guidance documents. they achieved an accuracy of 0. the Egyptians had anticipated the spirit of the present day system of legal metrology. temples. However. With this standardization and uniformity of length. the Egyptians achieved surprising accuracy. Workers engaged in building tombs. 12 . The need for calibration has been around for at least 5000 years. etc. if a company is manufacturing a drug that must meet regulatory requirements. Failure to do so was punishable by death. they pay a company to audit them to that standard to ensure they are following their quality manual and are within compliance. The Royal Architect or Foreman of the construction site was responsible for maintaining & transferring the unit of length to workers instruments. traceability and calibration recall. In the case of ISO standards. there are basically two types of requirements: ISO standards and regulatory requirements. and regulatory requirements are mandatory.Volume 4 of “The rules governing medicinal products in the European Union”. 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.36276 meters. In today’s calibration environment. detailed information for achieving regulatory compliance is provided in Eudralex . In Europe. they are inspected by government inspectors for compliance to federal regulations. In roughly 756 feet or 230. Thousands of workers were engaged in building the Great Pyramid of Giza.2 The “Royal Cubit Master” was carved out of a block of granite to endure for all times. 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).43 centimeters. pyramids. they were within 4.quality standards and industry regulations finger plus the width of the palm of the hand of the Pharaoh or King ruling at that time. Through the use of cubit sticks. Though the punishment prescribed was severe. On the other hand.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.05%. If an organization volunteers to meet ISO 9000 standards. The biggest difference between the two is simple – ISO standards are voluntary. standards. were supplied with cubits made of wood or granite.

3 – Definitions. Food and Drug Administration (FDA) Following are examples of some of the regulations required by the FDA.50 – Purchasing controls.1 – Scope.72 – Inspection. Subpart F – Identification and Traceability § 820. § 820. § 820. 13 .40 – Document controls. Subpart D – Document Controls § 820. Listed below are several different parts of 21CFR.5 – Quality system.20 – Management responsibility. and test equipment. § 820. § 820.quality standards and industry regulations Calibration requirements according to the U.65 – Traceability. S. § 820. Subpart E – Purchasing Controls § 820.22 – Quality audit. that relate to the calibration of test equipment in different situations and environments. Subpart C – Design Controls § 820. § 820. § 820.70 – Production and process controls. 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. Subpart B – Quality System Requirements § 820. measuring. Please note that European standards are similar to FDA requirements.60 – Identification.30 – Design controls.25 – Personnel. Subpart G – Production and Process Controls § 820.75 – Process validation. and what they say about calibration and what must be accomplished to meet the CFRs.

§ 820.181 – Device master record.140 – Handling.170 – Installation. and finished device acceptance.198 – Complaint files. Subpart O – Statistical Techniques § 820. Subpart L – Handling. in-process.72] TITLE 2 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H – MEDICAL DEVICES 14 . Storage. § 820. § 820.160 – Distribution. § 820.186 – Quality system record. Distribution.200 – Servicing.90 – Nonconforming product. [Code of Federal Regulations] [Title 21. and Installation § 820.184 – Device history record. 2012] [CITE: 21CFR820.80 – Receiving.86 – Acceptance status. § 820. § 820. Subpart K – Labeling and Packaging Control § 820. Subpart M – Records § 820.120 – Device labeling.250 – Statistical techniques.100 – Corrective and preventive action.quality standards and industry regulations Subpart H – Acceptance Activities § 820.150 – Storage.130 – Device packaging. § 820. § 820. Volume 8] [Revised as of April 1. Subpart I – Nonconforming Product § 820. § 820. Subpart J – Corrective and Preventive Action § 820. Subpart N – Servicing § 820.180 – General requirements.

15 . 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. When accuracy and precision limits are not met. Calibration procedures shall include specific directions and limits for accuracy and precision. and test equipment. and test equipment shall be traceable to national or international standards. and the next calibration date shall be documented. If no applicable standard exists. the manufacturer shall establish and maintain an in-house standard. and test equipment. so that its accuracy and fitness for use are maintained. These activities shall be documented. The procedures shall include provisions for handling. If national or international standards are not practical or available. 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. inspected. (a)  Control of inspection. the manufacturer shall use an independent reproducible standard. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated. (b)   Calibration.72 Inspection. Each manufacturer shall ensure that all inspection. These activities shall be documented. (2)   Calibration records. calibration dates. (1)   C alibration standards. automated. measuring. measuring. and test equipment. the individual performing each calibration. and maintained. preservation. 820. measuring. is suitable for its intended purposes and is capable of producing valid results. Calibration standards used for inspection. The equipment identification. including mechanical. measuring. and storage of equipment. checked. or electronic inspection and test equipment.quality standards and industry regulations PART 820–QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls Sec.

mechanical. including computers. (b)  Laboratory controls shall include the establishment of scientifically sound and appropriate specifications. and electronic equipment. drug product containers.quality standards and industry regulations [Code of Federal Regulations] [Title 21. Laboratory controls shall include: (1)  Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components.160 General requirements. and purity.68 Automatic. Written records of those calibration checks and inspections shall be maintained. may be used in the manufacture. 211. it shall be routinely calibrated. Volume 4] [Revised as of April 1. or related systems that will perform a function satisfactorily. or checked according to a written program designed to assure proper performance. labeling. (a)  Automatic. and drug products conform to appropriate standards of identity. quality. closures. If such equipment is so used. inspected. strength. sampling plans. 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. in-process materials. and test procedures designed to assure that components. or electronic equipment or other types of equipment. mechanical. packing. Sec. standards. processing. 16 . closures. 211. drug product containers. and holding of a drug product.

(4)  The calibration of instruments. 2008] Sec. drug product container. gauges. and recording devices at suitable intervals in accordance with an established written program containing specific directions. (2)  Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Samples shall be representative and adequately identified. [43 FR 45077. gauges. The specifications shall include a description of the sampling and testing procedures used. and recording devices required by 211. 17 . or holding of drug products.194 Laboratory records. (d)  Complete records shall be maintained of the periodic calibration of laboratory instruments. 29. apparatus. Such procedures shall also require appropriate retesting of any component. packing. apparatus. (3)  Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. 211. schedules. gauges. processing. or closure that is subject to deterioration. apparatus. Instruments. limits for accuracy and precision. Sept. 1978.quality standards and industry regulations and labeling used in the manufacture. 8. Such samples shall be representative and properly identified. and recording devices not meeting established specifications shall not be used. as amended at 73 FR 51932.160(b)(4). Sept. and provisions for remedial action in the event accuracy and/or precision limits are not met. Such samples shall be representative and properly identified.

quality standards and industry regulations

TITLE 2 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A – GENERAL PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A – General Provisions Sec. 11.1 Scope. (a)  The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b)  This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. (c)  Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997. (d)  Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with 11.2, unless paper records are specifically required.

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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.

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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.

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•  Equipment assembly and calibration. •  Internal quality/GMP compliance audits. equipment and systems.g. •  Recalls. for the following examples: •  Validation and qualification of processes. •  Change control. clothing and hygiene and verification of the effectiveness of training. •  Complaints.29 There should be written policies. training in GMP and technical matters. and areas where product has been processed. protocols. •  Supplier audits. cleaning and sanitation. including the dates and identity of people who carried these operations out. •  Personnel matters including signature lists. cleaning or repair operations. as appropriate. 22 . maintenance. calibrations. •  Environmental monitoring. •  Pest control. 4. •  Investigations into deviations and non-conformances. •  Maintenance. any use of the area. where appropriate. procedures. They should be used to record in chronological order. •  Technology transfer. •  Returns. product quality review).quality standards and industry regulations Procedures and records Other 4. equipment/method. production equipment.31 Logbooks should be kept for major or critical analytical testing. •  Summaries of records where appropriate (e. reports and the associated records of actions taken or conclusions reached.

systems and equipment. where required. •  validation records of test methods. •  data from environmental monitoring. (b)  icollection and collation of supplier operating and working instructions and maintenance requirements. Annex 15 to the EU Guide to Good Manufacturing Practice Title: Qualification and validation QUALIFICATION Installation qualification 11. •  testing procedures and records (including analytical worksheets and/ or laboratory notebooks). services and instrumentation checked to current engineering drawings and specifications.quality standards and industry regulations Chapter 6 Quality Control Good Quality Control Laboratory Practice Documentation 6. (c)  icalibration requirements. •  analytical reports and/or certificates. IQ should include. where applicable. 12. •  procedures for and records of the calibration of instruments and maintenance of equipment. but not be limited to the following: (a)  installation of equipment. (d)  verification of materials of construction. •  sampling procedures.7 Laboratory documentation should follow the principles given in Chapter 4. 23 . An important part of this documentation deals with Quality Control and the following details should be readily available to the Quality Control Department: •  specifications. piping. Installation qualification (IQ ) should be performed on new or modified facilities.

quality standards and industry regulations Operational qualification 15. operating procedures and operator training procedures and records should be documented. but not be limited to the following: (a)  short description of the process. (k)  proposed timetable. (i)  methods for recording and evaluating results (j)  functions and responsibilities. with acceptance criteria and analytical validation. operating and cleaning procedures. (h)  sampling plan. It should permit a formal “release” of the facilities. (b)  summary of the critical processing steps to be investigated. Evidence should be available to support and verify the operating parameters and limits for the critical variables of the operating equipment. as appropriate. as appropriate. 24 . PROCESS VALIDATION Prospective validation 24. (f)  proposed in-process controls with acceptance criteria. (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. Qualification of established (in-use) facilities. systems and equipment. Prospective validation should include. systems and equipment 19. operator training and preventative maintenance requirements. (e)  list of analytical methods. Additionally. (g)  additional testing to be carried out. cleaning. preventative maintenance. the calibration. The completion of a successful Operational qualification should allow the finalisation of calibration.

pdf EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels.eu/health/documents/eudralex/vol-4/index_en. This document provides guidance for the interpretation of the principles 25 .quality standards and industry regulations EU GMP Annex 11 The EU GMP Annex 11 defines EU requirements for computerised systems.europa.Volume 4 Good manufacturing practice (GMP) Guidelines: http://ec.htm PDF of Annex 11: http://ec. 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. Main page for the EudraLex . and applies to all forms of computerised systems used as part of GMP regulated activities.eu/health/files/eudralex/vol-4/annex11_01-2011_ en.europa.

Where a computerised system replaces a manual operation. B-1049 Bruxelles / Europese Commissie. The application should be validated. IT infrastructure should be qualified. PIC/S The abbreviation PIC/S describes both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) which operate together.). process control or quality assurance. Further information can be found at the PIC/S Web site (http://www.quality standards and industry regulations and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. 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. A computerised system is a set of software and hardware components which together fulfill certain functionalities.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. Deadline for coming into operation: 30 June 2011 Commission Européenne.org/. There should be no increase in the overall risk of the process. Consequential amendments are also proposed for Chapter 4 of the GMP Guide. picscheme. It aims to promote harmonisation of global regulations for the pharmaceutical industry. there should be no resultant decrease in product quality. 26 .

There is also a series of related GAMP® guidance on specific topics. including: •  GAMP ® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) •  GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) •  GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) •  GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems . This is the latest major revision and was released in January 2008. such as GAMP® Americas. and GAMP® Americas support the GAMP® Council which oversee the operation of the COP and is the main link to ISPE. The most well known GAMP® publication is GAMP ® 5 A RiskBased Approach to GxP Computerized Systems. The GAMP® COP aims to provide guidance and understanding concerning GxP computerized systems. GAMP® Italiano and GAMP® Japan.quality standards and industry regulations GAMP® GAMP® is a Community of Practice (COP) of the International Society for Pharmaceutical Engineering (ISPE). 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. GAMP® Nordic. Since 1994. GAMP® DACH (Germany. Several local GAMP® COPs. Three regional Steering Committees. GAMP® Europe. in collaboration with ISPE’s local Affiliates in these regions. Switzerland). 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 . produce technical content and translate ISPE technical documents. the organization entered into a partnership with the ISPE and published its first GAMP® guidelines. They also bring the GAMP® community closer to its members. COPs provide networking opportunities for people interested in similar topics. GAMP® Japan. GAMP® Francophone. Austria.

All calibrations must be traceable to a national or international standard or artifact. providing a structured approach to instrument risk assessment.6  CONTROL MONITORING AND MEASURING EQUIPMENT •  Identify your organization’s monitoring and measuring needs and requirements (if your test instrument makes a quantitative measurement. A set of associated attachments are also available through the ISPE website. The Guide describes the principles of calibration and presents guidance in setting up a calibration management system.  •  Establish monitoring and measuring processes (calibration procedures and calibration record templates for recording your calibration results). and analytical instrumentation. calibration program management. The second edition of the guide has been significantly updated to address the change in regulatory expectations and in associated industry guidance documents. ISO 9001:2008 Basically. this is what is required according to ISO 9001:2008 7. documentation.  28 . The scope now includes related industries. laboratory. and corrective actions vital to regulatory compliance. it requires periodic calibration).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. and select test equipment that can meet those monitoring and measuring needs and requirements.  •  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).

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”. ISO 17025 ISO 17025 – General requirements for the competence of testing and calibration laboratories. According to ISO 17025. especially when the out of tolerance item is a calibration standard. second-. and your calibration standards). then you do not have any obligation to meet the ISO 17025 standard. and third-party laboratories. 29 .quality standards and industry regulations •  Protect your monitoring and measuring equipment (this includes during handling.  •  Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out-ofcalibration (as stated in the FDA regulations. QSR. and may have affected numerous items of test equipment over a period of time). 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. transportation. your test instruments may need to be qualified prior to use). preservation.3-2006 ANSI/NCSL Z540. These include first-. Please keep in mind that if your calibration function and/or metrology department fall under the requirements of your company. etc. rather it be for compliance to an ISO standard (ISO 9001:2008 or ISO 13485) or an FDA requirement (cGMP. storage.3-2006 – American National Standard for Calibration-Requirements for the Calibration of Measuring and Test Equipment. and laboratories where testing and/or calibration forms part of inspection and product certifications. this is just as applicable when dealing with ISO as with any other standard or regulation.). You already fall under a quality system that takes care of your calibration requirements. “When accuracy and precision limits are not met. and shipping of all test instruments – to include your customer’s items. ANSI/NCSL Z540. this standard is applicable to all organizations performing tests and/or calibrations.

service. In addition. In implementing its objective. This is done through the use of a system of functional components. •  the compatibility of measurements with the National Measurement System. international.1 (R2002) and Military Standard 45662A. or purchaser that receives a product or service. •  applying best practices and experience with related national. The “Customer” may be a consumer. certification.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. •  suppliers when specifying products offered. This National Standard is written for both Supplier and Customer. or information. •  legislative or regulatory bodies. Part 11 of ANSI/NCSL Z540. vendor. •  the suitability of a calibration for its intended application. and other evaluations of calibration systems and their components. retailer. this National Standard describes the technical requirements for establishing and maintaining: •  the acceptability of the performance of measuring and test equipment. and •  the traceability of measurement results to the International System of Units (SI). 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. industry. and •  assessment organizations in the audit. distributor. 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. and •  balancing the needs and interests of all stakeholders. Collectively. The “Supplier may be a producer. •  agencies or organizations as a contractual condition for procurement. this National Standard includes and updates the relevant calibration system requirements for measuring and test equipment described by the previous standards. enduser. each term being interpreted in the broadest sense. or a provider of a product. client. Reference to this National Standard may be made by: •  customers when specifying products (including services) required. 30 . and government standards.

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

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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.

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all of us pay more at the gas pump. and for manufactured goods that do not meet their stated specifications. for food weighed incorrectly at the checkout counter. their reputation. Their R&D section sends the formula to their operations & manufacturing division. Incorrect amounts of ingredients in your prescription and over-the-counter (OTC) drugs can cost more. then repeatable results would ensure that what’s made in one part of the company is also repeated in another part of the company. money. The amount of drugs confiscated in a raid determines whether the offense is a misdemeanor or a felony. Airliners fly into mountaintops and off the ends of runways because they don’t know their altitude and/or speed. and possibly the ability to stay in business simply because they do not use calibrated test equipment. or by using incorrect calibrations. They are not using calibrated test instruments in the company. or even cause illness or death. the cure for cancer is one of them. 35 . The company loses time. Crime labs cannot identify the remains of victims or wrongly identify victims in the case of mass graves. having the correct measurements throughout any and all industries is critical to national and international trade and commerce. The cure cannot be replicated with consistent results. Let’s    imagine that the Acme Biotech Co. Babies are not correctly weighed at birth. Without calibration. If all test equipment were calibrated to a traceable standard.a basic quality calibration program A basic quality calibration program R &D departments are tasked with coming up with the answers to many problems. criminals are either not convicted or are released on bad evidence. has found the cure for cancer. This scenario is repeated every day throughout the world. which weight is correct? As one can see. Measurements made by R&D are different than those made by the operations section. Because of poor or incorrect calibration. A fairy tale? Not hardly.

the purpose of which is to give guidance on the calibration and maintenance of measuring 36 . However. Many people are under the misconception that an item must be adjusted or aligned in order to be calibrated. we should explain two different traceability pyramids. 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. It does not make any difference if you adjust. and that is why it is being calibrated). and using a test uncertainty ratio (TUR) of ≥ 4:1. publication reference (EAL-G12) Traceability of Measuring and Test Equipment to National Standards. or certain parts of the world. The two examples in figures 1 and 2 are similar.a basic quality calibration program The bottom line is this – all test equipment that make a quantitative measurement require periodic calibration. align or repair the item. Nothing could be further from the truth. usually national or international standards. nor if you cannot adjust or align it. There are basically two ways to maintain traceability during calibration – the use of an uncertainty budget (performing uncertainty calculations for each measurement). When we talk about traceability to a national or international standard. we need to clarify two definitions that are critical to this subject – calibration and traceability. no matter the circumstances is called calibration. let’s discuss the use of uncertainty budgets. Before we can get any deeper into what traceability is. through an unbroken chain of calibrations all having stated uncertainties. The comparison to a standard that is more accurate. one of known uncertainty (your standard) and one of unknown uncertainty (your test equipment or instrument). so a graphic illustration of these pyramids is important. before we go any further. but differ depending on where you are in the chain. First. Traceability is the property of the result of a measurement or the value of a standard whereby it can be related to stated references. According to the European cooperation for Accreditation of Laboratories. It is as simple as that. By definition: Calibration is a comparison of two measurement devices or systems. The calibration of any piece of equipment or system is simply a comparison between the standard being used (with its known uncertainty).

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. supplier firms that make products. 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. must measure with the ‘same measure’.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. 37 .

the laboratories or bodies performing one or more steps in the chain must supply evidence for their technical competence. was in proper working order and was used correctly for controlling a product. e.g. (c)  documentation. uncertainty required. e. calibrations must be repeated at appropriate intervals.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. 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. stability of the equipment. (b)  measurement uncertainty.g. is not affected by defects. the results must equally be documented. usually a national or international standard. failure to meet these requirements means the absence of a warranted quality with considerable consequent liability. that adequate measuring and test equipment was chosen. 4. way of use. 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. if they are used properly.3  If it becomes necessary to prove absence of liability. by reference to a systematic and fully documented system. (f)  re-calibrations.a basic quality calibration program 4. the producer must be able to demonstrate. each step in the chain must be performed according to documented and generally acknowledged procedures. the chain of comparisons must end at primary standards for the realization of the SI units. 4. the length of these intervals will depend on a number of variables. 5  Elements of traceability 5. (d)  competence. by demonstrating that they are accredited.2  There are legal as well as technical reasons for traceability of measurement. (e)  reference to SI units.4  There are similar technical and legal reasons why calibration and testing laboratory operators should have consistent control of measuring and test equipment in the manner described. Note: If binding requirements for the accuracy of measuring  and test equipment have been stipulated. 38 . frequency of use.

you must ensure your standards are at least four times (4:1) more accurate than the test equipment being calibrated. The purpose of this document is to harmonise evaluation of uncertainty of measurement within EA. is at the company or shop level. the specific demands in reporting uncertainty of measurement on calibration certificates issued by accredited laboratories and to assist accreditation bodies with a coherent assignment of best measurement capability to calibration laboratories accredited by them. Keep in mind that a TUR of 4:1 somewhere along the chain of calibrations may not have been feasible.2  In many fields.1 The other document that goes hand-in-hand with this is EA 4/02. where the customer’s test 39 . reference materials take the position of physical reference standards. then traceability is assured. in addition to the general requirements of EAL-R1. Expression of the Uncertainty of Measurement in Calibration. if a TUR of equal to or greater than 4:1 is maintained. published by seven international organisations concerned with standardisation and metrology. 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.2 By understanding and following both of these documents. without using uncertainty budgets or calculations. the implementation of EA-4/02 will also foster the global acceptance of European results of measurement. 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.” So. to set up. To maintain traceability. and uncertainty calculations were performed and their uncertainty stated on the certificate of calibration. In most circumstances. This is correct and acceptable. the TUR shall be equal to or greater than 4:1.32006) which states: “Where calibrations provide for verification that measurement quantities are within specified tolerances…Where it is not practical to estimate this probability. It is equally important that such reference materials are traceable to relevant SI units. Certification of reference materials is a method that is often used to demonstrate traceability to SI units. Where does this ratio of four to one (4:1) come from? It comes from the American National Standard for Calibration – (ANSI/NCSL Z540.a basic quality calibration program 5.

If everyone was using the calibration procedures like they were supposed to. If a change has been made to that procedure. However.a basic quality calibration program equipment is usually used for production or manufacturing purposes only. Four of them work in another facility calibrating the same types of equipment as the other two. They have calibrated the same items for several years and feel there is nothing new to learn. the calibration technician must be trained on the change before they can perform the calibration. The four calibration technicians that have been following the calibration procedure improve their production and save the company money. and the appropriate documentation completed to show that training 40 . But especially true in a metrology department. They submit a change proposal for the calibration procedure and everyone is briefed and trained on the new technique. This is applicable in every phase of a production and/or manufacturing program. more economical way to perform a specific calibration. Of course not. in a consistent output from those processes. But they must have their calibration procedure on hand each time they are performing the calibration. 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. 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. One of the four calibration technicians (who are always following the calibration procedures) finds there is a fast. 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. The effective operation of such a system will hopefully result in stable processes and. it is possible to initiate process improvements.3 Let’s take for example a calibration program that has six calibration technicians on staff. 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. then this would not have happened. Once stability and consistency are achieved. therefore. The two ‘old timers’ have a reduction in their production and actually cost the company money.

including what your standard(s) read or indicated both before and after any adjustments might be made. These items are also referred to by other standards (ISO 9000. or upper/lower limits specified in your procedures or instructions. This includes calibration procedures. work instructions and standard operating procedures (SOPs). Record what you did.3 “Say what you do” means write in detail how to do your job.) and regulations throughout most industries that regulate or monitor production and manufacturing of all types of products. The basic premise and foundation of a quality calibration program is to “Say what you do. and Act on the difference”. When the proper training is not documented and signed off by the trainer and trainee. Do what you say. accuracies. then it is the same as if the training never happened. or perform a function that follows specific written instructions. 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). One of the most stringent requirements can be found in the current Good Manufacturing Procedures (GMP).a basic quality calibration program was accomplished and signed off. change a process. you’re required to inform the user/owner of the equipment because they may have to re-evaluate manufactured goods. etc. This includes calibration procedures. Check the results. “Record what you did” means that you must record the results of your measurements and adjustments. “Check the results” means make certain the test equipment meets the tolerances. “Do what you say” means follow the documented procedures or instructions every time you calibrate. All of your calibration procedures should be formatted the same as other SOPs within your company. or recall a product. work instructions and SOPs. Here is an example of common formatting for SOPs: 41 . Let’s break these down into simple terms. “Act on the difference” means if the test equipment is out of tolerance. “Say what you do” means write in detail how to do your job.

  Forms and Records 8. Definitions. Manufacturer’s manuals usually provide an alignment procedure that can be used as a template for writing a calibration procedure. Have a system in place for updating your 42 .  Related Procedures 7. Specific: spectrophotometers. pipettes. you should have a table listing all of the instruments or systems that would be calibrated by that procedure. 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. and balances/scales.  Procedure 6. Have the latest edition of the procedure available for use by your calibration technicians. or perform a function that follows specific written instructions. Generic SOPs are written to show how to calibrate a large variety of items in a general context. the calibration form is designed to follow specific steps (number wise). This table should also include the standard’s range and specifications. pressure and vacuum gages.  Scope 3. There are.  Procedures 2. Possibly.  Definitions 5. generally speaking.  Responsibilities 4. micrometers.  Document History After section 4. They should show what standards accomplish the calibration of a specific range and/or function. This means following published calibration procedures every time you calibrate a piece of test equipment. along with their range and tolerances. After that you should have a list of the standards to be used to calibrate the items. and removes doubt by the calibration technician on what data goes into which data field. Procedures. thermal cyclers. Specific SOPs are written to show stepby-step procedures for each different type of test instrument within a group of items. Then the actual calibration procedure starts in section 5. “Do what you say” means follow the documented procedures or instructions every time you calibrate.a basic quality calibration program 1. two types of calibration procedures: Generic: temperature gages and thermometers. A complete calibration must be performed prior to any adjustment or alignment. power supplies and water baths.

the last time it was calibrated. What do you do when you need to make an improvement. and keep your calibration records in a secure location. written process must be in place. adjustment or repair. The entire calibration is performed to see any part of the calibration is out of tolerance. Certain requirements must be documented in each calibration record. A history of each calibration and a traceability statement or uncertainty budget must be included. There should be a place to show what the standard read. If an out-of-tolerance (OOT) condition is found.a basic quality calibration program procedures. their part number and range/tolerance. The location of where the test instrument can be found should also be on the record. 43 . The ‘As Found’ readings are what the test instrument read the first time that a calibration is performed. as well as the test instrument’s ‘As Found’ and when applicable ‘As Left’ readings. and the next time it will be due calibration should be on the form. prior to alignment. including what your standard(s) read or indicated both before and after any adjustments are made. 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. or update your calibration procedures and/or forms? A formal. Train your technicians on the changes made to your procedures every time the procedure is changed or improved – and document the training. The date of calibration. e. including: •  pen and paper •  “do-it-yourself ” databases. 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. Of course there are many ways to accomplish this.g. Excel.

In some circumstances. If one were to stop at the point where an OOT is found. while still meeting its specifications. the standard is set at a predetermined output. If the item is found to be out-of-tolerance at that time. alignment. a final ‘As Left’ calibration would be performed. There will be times when an instrument has a catastrophic failure. Compare this to the calibration of pressure gages where a pressure standard is set to a standard pressure. Not all UUTs would be considered OOT when “As Left’ readings are taken. and the temperature standard is used to record the actual reading. This is why the entire calibration is performed prior to adjustment or alignment. The standard reading. or adjustment. alignment or adjustment and that after a final adjustment was completed to bring the unit back into tolerance.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. 44 . The calibration is performed. Then the PMI is completed. there would not be a problem since it was found to be in tolerance during the first calibration. 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. an ‘As Found’ calibration is performed. after the UUT is adjusted to be as close to optimum as possible. make an adjustment. Another example would be when preventive maintenance inspection is going to be performed on an item. there will be times when this is not possible. The UUT is treated the same as any OOT unit. One example when it would not be practical to set the standard and take a reading is during the calibration of water baths. once the problem is found and repaired. However. It just dies and cannot be calibrated. This should be noted in the calibration record. and the UUT is read to see how much it deviates from the standard. from the working or reference standard you are using to calibrate the UUT. The water bath is set to a predetermined temperature. then proceed with the calibration. will also be recorded on the calibration form. but you would not have been able to collect the original “As Found’ readings. In this type of situation. and an ‘As Left’ set of data is collected. collecting the ‘As Found’ data. a complete calibration is again performed. Then. collecting the ‘As Left’ readings for the final calibration record. there is a good possibility that the adjustment affected other ranges or parts of the calibration. This is a best practice policy that has been in use in the metrology community since calibration started. “As Left” readings are taken after repair. Usually.

are placed in a dry block and a particular temperature is set. dust. In other case. The UUT is compared to the reference after equilibration. Note: Influencing factors and conditions may include temperature. and mitigated to meet calibration process requirements. etc.3-2006. There must be a statement showing traceability to your NMI. to NIST. They. recorded. along with their next calibration due date(s). along with the procedure’s revision number.”5 If the conditions within the area that calibrations are being performed require monitoring according to the standard or requirements that must be met. plus their specifications and range. Also on the calibration form should be an area to identify the standard(s) that were used.11: “The calibration environment need be controlled only to the extent required by the most environmentally sensitive measurement performed in the area. You should include any uncertainty budgets if used. or in the case of most companies in the USA.3. or to any artifact that was used as a standard. Calibration shall be stopped when the adverse effects of the influence factors ad conditions jeopardize the results of the calibration. electromagnetic interference. or at least a statement that a TUR of ≥ 4:1 was met. just as the calibration of autoclaves. then a formal program must be in place for tracking those conditions and reviewing the data.a basic quality calibration program and the gage(s) under test are then read. and a determination is made as to the in or out of tolerance of the UUT. humidity. vibration. 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. along with the standard. and their pressures recorded on the calibration record.”4 According to ANSI/NCSL Z540. and compared to the standard to see if they are in or out of tolerance.6 Influence factors and conditions: “All factors and conditions of the calibration area that adversely influence the calibration results shall be defined. paragraph 5. paragraph 5. then there should be a place in the calibration form for showing that those conditions were 45 . The same happens when calibrating thermometers. monitored. There should also be a place to identify which calibration procedure was used. As can be seen by the above examples. it is not always possible to set the standard and take a reading from the UUT. According to NCSL International Calibration Control Systems for the Biomedical and Pharmaceutical Industry – Recommended Practice RP-6. If this is the case. List environment conditions when appropriate and show if they pass or fail.

Enough space should be available for the calibration technician to include information about the calibration. or erase the original data. What do you do if. then there should be a place to show what happened to the UUT. audited. draw a single line through the entry. and then place your initials and date next to the data using black ink. This means that an individual higher up the chain of command (supervisor. The user/customer. This is called for in all of the standards and regulations. And finally. etc. etc. If the UUT had an out-of-tolerance condition. •  The user/customer was notified and the UUT was taken out of service and tagged as unusable. even if internal to the company performing the calibrations.) must review the calibration record and also sign and date that it has been reviewed. or inspected before it is considered a completed record. QA inspector. Do not use white-out. the calibration record requires a ‘second set of eyes’. must be informed if their test equipment does not meet their specifications. Notice that in each circumstance that the user/customer must be notified of any and all OOTs. both hard copy 46 .a basic quality calibration program either met. There should be an area set aside in the calibration form for making comments or remarks. There should be only one way to file your records. and date and sign accordingly. with the following possibilities as an example:  •  The user/customer was notified and the UUT was adjusted and meets specifications. the calibration record must be signed and dated by the technician performing the calibration. •  The user/customer was notified and the UUT was given a ‘limited calibration’ with their written approval. For making corrections to electronic records (eRecords). and want to correct the error? For hard copy records. In some instances. what was accomplished if an OOT was found. were not met. there should be a place on the form for the final reviewer to sign and date. You should indicate on the form if the calibration passed or failed. or make a duplicate record from scratch with the correct data and explain in the comments block what happened. OOT conditions. write the correct data. If this is the case. after recording your results. or are not applicable to that calibration. you find that you have made an error. manager. or transposed the wrong numbers. use whatever tracking system the software uses.

analysis. put it into your written procedures. Hard copy records collected during the calibration of test instruments have been discussed in detail already. Is the system validated and instrumentation qualified prior to use? If you are using any type of computerized system. review and store the data. accuracies. How is the data collected and stored? Is it in its native format or dumped into a spreadsheet for analysis? All of these need to be considered to allow for review. process controllers. or upper/lower limits specified in your procedures or instructions. etc. 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. should also be considered. “Check the results” means make certain the test equipment meets the tolerances.a basic quality calibration program and eRecords – no matter which system you use. manage. In some instances it is apparent what the tolerances will be for the items being calibrated. In other cases it is not quite so apparent. and/or compilation into your forms. data lines and storage systems when going entirely electronic with your calibration records and data management. and eventual storage. There are various ways to do this. The use of computerized data collection brings with it not only increased productivity and savings in time and effort. It cannot be emphasized enough the criticality of validating your software. validation of that software is mandatory. or through the use of calibration software. But the collection of data by electronic means. Calibration forms should have the range and their tolerances listed for each piece of test equipment being calibrated.. 47 . but also new problems in how to collect. 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.

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. or recall product. According to the FDA: “When accuracy and precision limits are not met. change a process or procedure. if so is there a time limit.” You should have a written procedure in place that explains in detail: •  What actions are to be taken by the calibration technician? •  What actions to be taken by the department supervisor and/or manager? •  What actions to be taken by the responsible owner/user of the OOT test equipment? You should have an SOP that explains the responsibilities of the calibration technician: •  Do they have additional form(s) to complete when OOT conditions are found? •  Do they require a ‘second set of eyes’ when/if an OOT is found? •  Have they been trained and signed off that they know all the proper procedures when an OOT has been found? You should have an SOP that explains the responsibilities of the supervisor/manager: •  Who notifies the customer – the technician. you must inform the user because they may have to re-evaluate manufactured goods. there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. •  Are there any databases that need to be updated. supervisor or manager? •  Is a data base maintained on all OOT test equipment? •  Is the customer/user required to reply to the OOT notification.a basic quality calibration program “Act on the difference” means if the test equipment is out of tolerance. and a paper trail for historical reference? After owner/user notification. or upper management notification in case of ‘in action’? 48 .

Here is a hypothetical example: from an historical perspective. •  Among the 15% that are found to be OOT some will be due to Start Typical calibration process as shown in a flow chart ‘As found’ test Save ‘As found’ results NO Adjustment required? YES Adjust as needed ‘As Left’ test YES Within limits? NO Save ‘As Left’ results End 49 . generally 85% of test equipment passes calibration. •  Access to OOT data can assist in determining reliability of test equipment.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. •  During an audit/inspection (both internal and external) access to past OOT data should be easily available.

items that are OOT. Without any one of these programs. By knowing what is coming due calibration. you can schedule your technicians. poorly written calibration procedures. Having an effective calibration management program is usually the difference between being proactive and reactive to performing your routine calibrations. The “Say what you do. the ability to see a 30 day schedule of items coming due calibration. •  If a higher fail rate is noticed.). groups of items by location/part number. reverse traceability. scheduling and calibration management software. bad standards. and Act on the difference” portion. correct and properly used calibration and equipment labels. Do what you say. 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. a comprehensive calibration analysis program. and other listings that help to manage your department. check that the proper specifications are being used. However. But the different parts that keep a quality calibration program running efficiently consist of elements from a continuous process improvement program. along with traceability should be apparent to an auditor or inspector. Any calibration management program worth the money should have a few critical areas built into their basic program.a basic quality calibration program operator error. standards. Those include: a master inventory list. Record what you did. time and other resources to the best advantage. etc. the unseen portion is what keeps the iceberg afloat and stable in the ocean. From a managerial standpoint. This can be compared to the person who is trying to drain the swamp while fighting off the alligators. and the ability to see all items that are currently overdue calibration. Check the results. before changing calibration intervals. bad cables/accessories. a quality calibration program would be impossible to maintain. Only about 10% can be easily seen by the casual observer. any software program used must be validated prior to implementation. and a visible safety program. the calibration management program should also be able to show calibrations and repairs by individual items. environmental conditions (vibration. The same can be said of a quality calibration program. Developing a world-class calibration program A quality calibration program might be compared to an iceberg. According to most standards and regulations. This can be accomplished using the manufacturer’s 50 . an effective training program.

etc. An example of this would be to calibrate all pressure gages that were shown to be stored or used in a specific area. A particular item used in a controlled environment should be more reliable that one used in a harsher situation. environment. say outdoors in severe weather. if calibrations were to be performed in a ‘clean room’ environment. Most manufacturers recommend a 12 month calibration interval. return to finish the pipette or balance calibrations. Also. Calibration interval analysis software can be purchased commercially 51 . depending on usage. increasing productivity. Either way. then perform several pipette or balance calibrations. return to set another temperature in the water baths (doing a few at a time). your validation paperwork needs to be available for inspection during audits and inspections. 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. handling. Combining the calibration of like items and mixing and matching items could reduce the task of mundane and boring calibrations. and using your scheduling software to also perform calibrations in geographical areas or combining calibrations in local areas. or by incorporating an in-house validation system. or floor of a building. and the calibration technician is required to gown-up prior to entry every time then go into the clean-room. Another critical yet often times misunderstood program is calibration interval analysis. then complete the water baths at their final setting. A best practice among experienced calibration practitioners is the calibration of like items. This would be using your time to the best advantage. 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. By not having to stand around to wait for the water baths to equilibrate. An example would be to start all temperature calibrations (set water baths up for their initial temperature readings). then scheduling all of the calibrations in that area could increase production and reduce down time from multiple entries and exits. Also. you are using your time more efficiently.a basic quality calibration program system. and keeping the calibration technician involved and focused instead of bored. Each situation should be considered carefully so that they can be reviewed in the appropriate light.

On one side we have the requirement of standards and regulations that govern various companies. 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. NCSL International has RP-1. or are on a tight budget and are willing to do their own computations. then take the result times 100 for the pass rate •  Make a risk assessment of each item for your company’s needs. recalls can be very expensive. in time and money. but 52 . A company could also do their own analysis if they support a limited number of items. implement and manage calibration interval determination. Both management and technical information are presented in this RP. 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. adjustment and evaluation programs. divide result by the number of calibrations. industries and even countries. Also. •  For each type of equipment. Not only is calibration a requirement. Establishment & Adjustment of Calibration Intervals. It provides information needed to design. It isn’t a question of do you have a quality calibration program in place. The advantages and disadvantages of each method are described and guidelines are given to assist in selecting the best method for a requiring organization. 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. but one of the foundations for any quality system in the 21st century. Here is an example.a basic quality calibration program and used to evaluate your test equipment. This Recommended Practice (RP) is intended to provide a guide for the establishment and adjustment of calibration intervals for equipment subject to periodic calibration. Several methods of calibration interval analysis and adjustment are presented.

and reputation. calibration interval analysis. Then you can say you have a quality calibration program. documented training for all your calibration technicians. The basic belief is this – it is absolutely essential to have a quality calibration program in place to make a quality product. This would equate to not having any type of calibration program at all. Referring to a double edged sword. traceability or documentation. there can be no repeatability. or intrinsic). time. The cost is huge in terms of lost production. a training program. shape. 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. you must also have all the parts needed to support traceable calibration: calibration procedures. traceable documentation. Therefore there can be no quality in the product. In the case of companies that have untraceable calibration in the production of medical devices. 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. document control procedures. continuous process improvements. or quantity. But it doesn’t end there. a comprehensive calibration management software package. an out-oftolerance program and procedures. money.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. pharmaceutical drugs and products that impact human safety – the cost could be immeasurable…with the possibility of death among the results. what are the responsibilities of a quality calibration department and also those of their customer? A calibration/metrology department should be responsible for: •  Listening to their customers to understand their requirements and needs 53 . calibration records. no matter the size. So is there cost and risk? Absolutely. then it is assumed that to have a quality calibration program. and the ability to provide quality customer service in a timely manner. international. so the company would never be able to stay in business long enough to impact their market segment. Without calibration to a traceable standard (national.

  EA-4/02. November 1995.  NCSL. 2007. Edition 1. Boulder. RP-6. 3. 54 .  NCSL International. 1999. 4. or in need of calibration As Lord Kelvin was quoted as saying. 2006. Calibration Control Systems for the Biomedical and Pharmaceutical Industry. CO. 2.  EAL-G12. Jay L. you cannot improve it. The Quality Calibration Handbook.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.3-2006. CO. 5. Boulder. Milwaukee: ASQ Quality Press. Expression of the Uncertainty of Measurement in Calibration. “If you cannot measure it. December 1999 rev00.” 1. malfunctioning.  Bucher. Traceability of Measurement. contaminating or damaging it under normal operating conditions •  Using their work order system for requesting service when equipment is broken. ANSI/NCSL Z540.

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To be able to answer the question why calibrate.  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. calibrator.e. i. repeatability. 1.traceable and efficient calibrations Traceable and efficient calibrations in the process industry T oday’s modern process plants. production processes and quality systems. put new and tight requirements on the accuracy of process instruments and on process control. which means that the calibrator used should have a valid. call for systematic and well-documented calibrations. uncertainty. Quality systems. However. terminology and methods involved in calibration must be known and understood in order to perform according to International Quality Systems. Does this mean that the electricians and instrumentation people should be calibration experts? Not really. such as the ISO9000 and ISO14000 series of quality standards. calibrator.e. confidence levels etc. Calibration can briefly be described as an activity where theinstrument being tested is compared to a known reference value. with regard to accuracy. i. 57 . Fortunately. we must first determine what measurement is and why measuring is necessary. modern calibration techniques and calibration systems have made it easier to fulfill the requirements on instrumentation calibration and maintenance in a productive way. traceable calibration certificate. but this topic should not be ignored. The keywords here are ‘known reference’. some understanding of the techniques.

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. in general. Departments House and working standards Process instrumentation 58 . Note: the true value of a quantity is an ideal concept and.” What is then the value of quantity? According to the standards the true value of a quantity is: “The value which characterizes a quantity perfectly defined during the conditions which exist at the moment when the value is observed.” Therefore all instruments display false indications! A set of experimental operations for the purpose of determining the value of a quantity. it cannot be known. HIERARCHY OF ACCURACY TRUE VALUE International National standard Authorized Laboratories Instr.

in other words. manpower and capital into products in the best possible way. which must be done better than the competitors. Anyhow.  Why calibrate The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability.traceable and efficient calibrations 2. The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability. energy. they drift and lose their ability to give accurate measurements.  Why measure? The purpose of a process plant is to convert raw material. 3. This conversion always involves optimizing. regardless of how advanced the process automation system is. optimization is done by means of process automation. In practice. EVERYTHING IS BASED ON MEASUREMENTS PROCESS CONTROL SYSTEM MEASUREMENTS CONTROLS INSTRUMENTATION MEASUREMENTS ADJUSTMENTS Production Factors PROCESS Products 59 . in other words. the control cannot be better than the quality of measurements from the process.

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 . elapsed time and type of application can all affect the stability of an instrument.traceable and efficient calibrations they drift and lose their ability to give accurate measurements. Even instruments of the same manufacturer. which produces uniform quality and minimizes the negative impacts on the environment. Other good reasons for calibration are: •  To maintain the credibility of measurements •  To maintain the quality of process instruments at a good-as-new level •  Safety and environmental regulations •  ISO9000. type and range can show varying performance. elapsed time and type of application can all affect the stability of an instrument. systematic calibrations. while another performs differently. Environment conditions. Environment conditions. This drift makes recalibration necessary. other quality systems and regulations The ISO9000 and ISO14000 can assist in guiding regular. One unit can be found to have good stability.

to ensure valid results. the basis used for calibration or verification is recorded. Where necessary.  Traceability Calibrations must be traceable.  Regulatory requirements for calibration 5. protected from damage and deterioration during handling. safeguarded against adjustments that would invalidate the measurement result. If no such standards exist. In addition. This is done prior to initial use and reconfirmed as necessary. adjusted or re-adjusted as necessary. measuring equipment is calibrated or verified with measurement standards traceable to national or international standards at specified intervals. When used in the monitoring and measurement of specified requirements. 5. The organization establishes the processes for ensuring that measurements and monitoring are carried out and are carried out in a manner consistent with the monitoring and measurement requirements. Traceability is a declaration stating to which national standard a certain instrument has been compared. maintenance and storage. The organization then takes appropriate action on the equipment and any product affected. Records of the calibration and verification results are then maintained.1  ISO9001: 2008 The organization determines the monitoring and measurements to be performed.traceable and efficient calibrations 4. SI-UNITS International standards National standards Reference standards Working standards Process standards 61 . the organization assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. the ability of computer software to satisfy the intended application is confirmed. Note: See ISO 10012 for further information. identified for the determining of the calibration status. as well as the measuring devices needed to provide evidence of a product’s conformity to determined standards.

Audit Trail. •  Calibrations must be done in accordance with written. the Electronic Signature is considered equivalent to a hand-written signature. process and safety instruments should be physically tagged. 62 . approved procedures. edit. Audit Trails should record all modifications. Users must understand their responsibilities once they give an electronic signature. User Management. An Audit Trail is required to support change management. •  Calibration records must be maintained. •  Documented change management system must be in place. In such a system. •  Calibration standards should be traceable to national and international standards.2  PHARMACEUTICAL (FDA. •  There must be documented evidence that personnel involved in the calibration process have been trained and are competent. •  All electronic systems must comply with FDA’s 21 CFR Part 11. •  All instrumentation should have a unique ID. regardless of where the products are manufactured. •  There should be a record of the history of each instrument. Electronic Signatures” Software systems need features such as Electronic Signature. Audit Trail. and Security System to be able to comply with these regulations. •  Calibration standards must be more accurate than the required accuracy of the equipment being calibrated.S. or delete data from an electronic record. which add. U. Software systems need features such as Electronic Signature. •  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. •  A calibration period and error limits should be defined for each instrument. and Security System to be able to comply with these regulations. Food and Drug Administration) Any pharmaceutical company that sells their products in the USA must comply with FDA regulations.traceable and efficient calibrations 5. User Management. all product. •  All instruments used must be fit for purpose.

Quite a few of the following terms are also used on specification sheets for calibrators. 63 . Validation of measure­ ment and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use. Non-linearity is specified by the Terminal Based method or the Best Fit Straight Line method. Resolution Resolution is the smallest interval that can be read between two readings. Calibration An unknown measured signal is compared to a known reference signal.3 PHARMACEUTICAL (EU GMPs) Any pharmaceutical company that sells their products in the European Union must comply with EU GMPs.2. The requirements for EU GMPs are similar to those of the US FDA. regardless of where the products are manufactured. Please note that the definitions listed here are simplified. Validation Validation of measurement and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use. including Annex 11. 6. as described in Section 5. Non-linearity Non-linearity is the maximum deviation of a transducer’s output from a defined straight line.  DEFINITIONS OF METROLOGICAL TERMS Some metrological terms in association with the concept of calibration are described in this section.traceable and efficient calibrations 5.

under normal operating conditions. .  64 Stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. which can be detected as an output. usually 90 days to 12 months. / °C or % of RDG/ °C. Drift is usually given as a typical value. hysteresis. temperature effects etc. The difference between these two expressions is great. Stability Often referred to as drift. It must also be checked if errors like non-linearity. Good resolution is required in order to detect sensitivity. Repeatability is often expressed in the form of standard deviation. usually 90 days to 12 months. 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. The only way to compare accuracy presented in different ways is to calculate the total error at certain points. The accuracy of the reference value is generally not included in the figures.traceable and efficient calibrations Sensitivity Sensitivity is the smallest variation in input. when first approaching this point with increasing values.S. or % of RDG + adder. are included in the accuracy figures provided. Hysteresis The deviation in output at any point within the instrument’s sensing range. under normal operating conditions. Accuracy is usually expressed % F.S. stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. and then with decreasing values. The temperature coefficient is usually expressed as % F. Temperature coefficient The change in a calibrator’s accuracy caused by changes in ambient temperature (deviation from reference conditions). Accuracy Generally accuracy figures state the closeness of a measured value to a known reference value.

traceable and efficient calibrations Uncertainty Uncertainty is an estimate of the limits. uncertainty is calculated using Type A uncertainties. could be said to be of a systematic nature. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. at a given cover factor (or confidence level). set-up of the measuring. Standard deviation is used as a measure of the dispersion of values. Values belonging to this category may be derived from: It should be noted that. Systematic errors or effects remain constant during the measurement. Type A involves the statistical analysis of a series of measurements. there will be an observable difference in the values measured. which can vary in magnitude and in sign. 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 Type B evaluation of uncertainty involves the use of other means to calculate uncertainty. If there is sufficient resolution in the measurement. Type B uncertainty is used when the uncertainty of a single measurement is expressed. In this case. often called the “root-mean-square repeatability error”. It involves the evaluation of uncertainty using scientific judgement based on all available information concerning the possible variables. in an unpredictable manner. 65 . for a series of measurements under the same conditions. in general. etc.e. Type B. i. which contain the true value. The standard deviation. in general. ambient conditions. rather than applying statistical analysis of a series of measurements. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. It should be noted that. The other group of components. Examples of such errors include: errors in recording data. Examples of systematic effects include errors in reference value. Uncertainty is evaluated according to either a “Type A” or a “Type B” method. or the use of inappropriate technology. is used for calculation. errors in calculation. the effects of these components include measurement errors.

k=2. A well-based Type B evaluation of uncertainty can be as reliable as a Type A evaluation of uncertainty. should be used. there must be a clear statement of cover probability ­ or confidence level. For uncertainty specifications. 7. Usually one of the following confidence levels are used: 1 s = 68% 2 s = 95% 3 s = 99% For uncertainty specifications. In cases where normal (Gaussian) distribution can be assumed. especially in a measurement situation where a Type A evaluation is based only on a comparatively small number of statistically independent measurements. The expanded uncertainty corresponds to a coverage probability (or confidence level) of approximately 95%.  CALIBRATION MANAGEMENT Many companies do not pay enough attention to calibration management although it is a requirement e. the standard coverage factor. It is a skill that can be learnt with practice. in ISO9001: 2008.g. Expanded uncertainty The EA has decided that calibration laboratories accredited by members of the EA shall state an expanded uncertainty of measurement obtained by multiplying the uncertainty by a coverage factor k. The maintenance management system may alert when calibration is 66 . there must be a clear statement of cover probability or confidence level.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.

finding the sheets requires a lot of effort. The “As Found” and “As Left” are saved in the calibrator’s memory. using automated tools can be 5 to 10 times faster compared to manual recording. (s)he simply downloads the instrument details from the calibration management software into the memory of a documenting calibrator. There is no need to make tricky calculations manually in the field. what happens between opening and closing of the work order is not documented very often. the software automatically detects the calibrator that was used. Modern calibration management software can be a tool that automates and simplifies calibration work at all levels. Once the job has been done. Unfortunately. Depending on what process variable is calibrated and how many calibration points are recorded. While the calibration results are uploaded onto the database. An efficient calibration management system consists of calibration management software and documenting calibrators. If the calibration results need to be examined at a later time. 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. All this saves an extensive amount of time and prevents the user from making mistakes.traceable and efficient calibrations needed and then opens up a work order. it is usually in the form of a hand-written sheet that is then archived. no printed notes. effort and money. The increase in work productivity allows for more calibrations to be carried out within the same period of time as before. etc. 67 . When the technician is about to calibrate an instrument. are needed. Thus the calibrator is able to detect if the calibration was passed or failed immediately after the last calibration point was recorded. the work order will close and the maintenance system will be satisfied. If the software is able to interface with other systems the scheduling of calibrations can be done in the maintenance system from which the work orders can be automatically loaded into the calibration management software. The instrument’s measurement ranges and error limits are defined in the software and also downloaded to the calibrator. It automatically creates a list of instruments waiting to be calibrated in the near future. and there is no need to write down anything with pen. Choosing professional tools for maintaining calibration records and doing the calibrations can save a lot of time. and the traceability chain is documented without requiring any further actions from the user. If something is documented. Calibration records.

Although there is a lot of data involved. If the calibration management software includes the right tools. In addition to the conventional mA output of a transmitter. and they can be even used for configuring these “smart” transmitters. of course.traceable and efficient calibrations Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. When many tasks are automated. Transferring to a new calibration system may sound like a huge task and it can be a huge task. 68 . If paper copies of certificates are preferred. it is possible to use a “reverse traceability report” to get a list of instruments that have been calibrated with that calibrator. When all calibration related data is located in a single database the software is obviously able to create calibration related reports and documents. Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. If a calibrator drifts out of its specifications. it is possible to manage calibration records on computer without producing any papers. One of today’s trends is to move towards to a paperless office. be possible. temperature and electrical signals including frequency and pulses. are kept in the database. When an instrument has been calibrated several times. QA will find a calibration management system useful. The requested calibration records can be viewed on screen with a couple mouse clicks. 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. Good calibration tools help technicians work more efficiently and accurately. If the system manufacturer has paid attention usability. When an auditor comes for a visit. It is not very uncommon to have a calibrator that calibrates pressure. For instance the maintenance manager can use it as a calibration planning and decision-making tool for tracking and managing all calibration related activities. Today’s documenting calibrators are capable of calibrating many process signals. it does not mean the job is an enormous one. software displays the “History Trend”. instrument. therefore accessing previous results is also possible in just a few seconds. Foundation Fieldbus or Profibus output of the transmitters. the system is easy to learn and use. the users can concentrate on their primary job. which assists in determining whether or not the calibration period should be changed. printing them must. modern calibrators can also read HART.

planning. 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. analyzing and finally optimizing the calibration work. Maintenance databases.traceable and efficient calibrations Nowadays most companies have instrumentation data in some type of electronic format: as Excel spreadsheets. automated calibration system reduces workload because it carries out tasks faster. more accurately and with better results than what could be reached with a manual system. 69 . It assists in documenting. CONCLUSION A good. etc. Requirements” [2] 21 CFR Part 11: “Electronic Records. scheduling. Electronic Signatures” [3] 21 CFR Part 211: “Current Good Manufacturing Practice for Finished Pharmaceuticals” A good. automated calibration system reduces workload. References [1] ISO9001: 2008 “Quality Management Systems.

Calibration Management and Maintenance

why calibrate

Why Calibrate? What is the risk of not calibrating?

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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.

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neglecting calibration can lead to unscheduled production or machine downtime. Why is calibration important? Calibration ensures that instrument drift is minimized. also need to calibrate their weighing instruments. Product manufacturing also depends on accurate masses and so laboratories and production departments in the food and beverage. calibration has costs associated with it and in uncertain economic times. aviation companies. Furthermore. who invoice customers based on the mass of what they supply (fiscal metering). Similarly. an end product manufactured by a plant with poorly calibrated instruments could present a risk to both consumers and customers. harbors and retail outlets. These companies need to prove not only that the mass is accurate but also that the equipment producing the readings was correctly calibrated. Invoicing in these industries is often based on process measurements. oil and gas. Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. It is therefore critical that all instruments are calibrated at appropriate intervals. energy. paper and pulp. Weighing instruments also need to be calibrated regularly. allowing that sensor to drift over time could potentially result in a risk to employee safety. chemical and pharmaceutical industries. harsh 74 Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. . if the instrument is critical to a process or is located in a hazardous area. There is therefore a growing need to have the metrological quality of these weighing instruments confirmed by calibration. In certain situations. power.why calibrate The costs and risks of not calibrating Unfortunately. However. Fluctuating temperatures. Determining the correct mass of a product or material is particularly important for companies that supply steel. 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. This is particularly true for the food and beverage sector and for pharmaceutical manufacturers. this may even lead to a company losing its license to operate due to company not meeting its regulatory requirements. The stability of an instrument very much depends on its application and the environment it operates in. product and process quality issues or even product recalls and rework.

in addition to the BRC certificate of food safety. Quality systems such as ISO 9001. The role of calibration is very important to ensure the quality and safety of the processes. All the plants in Spain have received ISO 9001 and ISO 14001 certifications. instrument calibration can help to optimize a company’s production process or to increase the plant’s production capacity. 75 . He comments: “For Heineken. uncertainty and confidence levels. We must therefore ensure that all processes correspond to the planned characteristics. well-documented calibrations with respect to accuracy. On the people side.” Pharmaceutical manufacturers must follow current Good Manufacturing Practices. Incorrect measurements in a hazardous area could lead to serious consequences. energy and utilities industries. enabled the reactor power in each unit to be increased by 1. Standards must also be more accurate than the required accuracy of the equipment being calibrated. GMP. with all electronic systems complying with FDA regulations 21 CFR Part 11. there must be documented evidence that employees involved in the calibration process have been properly trained and competent. the quality of the beer is a number one priority. process and safety instruments should also be physically tagged. Calibration also ensures that product or batch quality remains high and consistent over time. by improving the measurement of reactor power parameters from 2% to 0. which has a significant effect on annual production capacity.why calibrate manufacturing conditions (dust and dirt) and elapsed time are all contributing factors here.6%. For example. Armando Rivero Rubalcaba is head of Instrumentation at beer producer Heineken (Spain). The company must also have a documented change management system in place. Furthermore. Safety is another important reason to calibrate instruments. In the power generation. repeatability. Production environments are potentially high risk areas for employees and can involve high temperatures and high pressures. requires that calibration records are maintained and calibrations have to be carried out in accordance with written. ISO 9002 and ISO 14001 require systematic.4%. a calibration interval and error limits should be defined for each instrument and standards should be traceable to national and international standards. Typically. at the Almaraz Nuclear Power Plant in Spain. The role of calibration is very important to ensure the quality and safety of the processes. This affects all process manufacturers. each instrument has a master history record and a unique ID. approved procedures. All product. Even instruments manufactured by the same supplier can vary in their performance over time.

” Neglecting to calibrate process instruments can also affect a company’s bottom line profits. As Jacek Midera. for example. Preparation of the right rubber mixture is precision work and a sample is taken from each rubber mixture to ensure quality. gas conversion devices must be extremely accurate in measuring delivered gas. controlling emissions is another critical factor for many process manufacturers. particularly in the oil and gas. accurate measurements ensure proper billing. This means that requirements for the calibrators are especially high.7 million US dollars every year. Customers want to pay for the exact amount of gas they’ve received. The latest Government regulations relating to carbon emissions may also require that companies calibrate specific instruments on a regular basis.” Today. The impact of even a small measurement error can be tremendous in terms of lost revenue. 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 . weighing scales or gas conversion devices. As he puts it: “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. Proper invoicing is therefore critical to energy and utilities companies. this figure rises dramatically to more than 4 million US dollars per year. Indeed. As Ed de Jong. Measuring instruments that yield wrong values could easily ruin the final product.why calibrate Calibration is of great importance. Instrument Maintenance Engineer at Shell (Netherlands) explains: “Until recently. This is particularly true if sales invoicing is based on accurate process measurements. including sensors used for measuring CO2 and NOX emissions. especially from the viewpoint of production safety and quality of the final product. poor quality calibration is on average costing manufacturers more than 1. according to recent research by Nielsen Research/ ATS Studies. measurement specialist at Mazovian Gas Company states: “Most importantly. Calibrating instruments can help to make combustion more efficient in industrial ovens and furnaces. manufacturers of food and beverage or pharmaceutical products could put their customers’ lives at risk by neglecting to calibrate their process instruments. Therefore. especially from the viewpoint of production safety and quality of the final product. petrochemicals and chemicals sectors. Heikki Karhe is a measurement technician at the tyre manufacturer Nokian Tyres. When only large companies with revenues of more than 1 billion US dollars are considered. Similarly.

instruments related to CO2 and NOX emissions. The main difference between fieldbus and conventional transmitters is that the output signal is a fully digital fieldbus signal.” Common misconceptions There are some common misconceptions when it comes to instrument calibration. as well as begin to monitor the stability or drift of the instrument over time. Just because a sensor is newly installed does not mean that it will perform within the required specifications. Quality standards may also dictate how often a pressure or temperature sensor needs calibrating. By calibrating an instrument before installation. When to calibrate Due to drift. 77 . calibration has an important role especially for the license to operate. For example. This is simply not true. this is not true. Another common misunderstanding is that new instruments do not require calibration. Changing the output signal does not change the need for periodic calibration. highly stable sensors are not calibrated as often as those sensors that are more susceptible to drift. Nowadays. How often they are calibrated depends on a number of factors. In this way. for example. Again. Government regulations demand that specific instruments must be calibrated. the manufacturer of the instrument will provide a recommended calibration interval. this does not eliminate the need for calibration. First. The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. The optimal calibration interval for different instruments can only be determined with software-based history trend analysis. some manufacturers claim that they do not need to calibrate their fieldbus instruments because they are digital and so are always accurate and correct. The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. all instruments require calibrating at set intervals. Although fieldbus transmitters have been improved in terms of their measurement accuracy when compared to analogue transmitters. This interval may be decreased if the instrument is being used in a critical process or application.why calibrate involved for both customers and governments [fiscal metering]. a company is able to enter all the necessary instrument data to its calibration database or calibration management software.

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quality. Decisions then need to be made regarding the calibration interval for each instrument. But in order to understand how software can help process plants better manage their instrument calibrations. and accuracy of data and their level of automation. different companies from a diverse range of industry sectors use very different methods of managing these calibrations. pressure transducers and weighing instruments – require regular calibration to ensure they are performing and measuring to specified tolerances. 79 . The creation and approval of standard operating procedures (SOPs) for each device is then required. All plant instruments and measurement devices need to be listed. Plant instrumentation devices such as temperature sensors. with documentation being a critical part of this. then classified into ‘critical’ and ‘non-critical’ devices. Finally. These methods differ greatly in terms of cost. However. the calibration range and required tolerances need to be identified. Calibration software is one such tool that can be used to support and guide calibration management activities. organisation. comprising of planning and decision-making. Once this has been agreed. Careful planning and decision-making is important. and analysis. with documentation being a critical part of this. There are five main areas here. execution. the company must identify current calibration status for every instrument across the plant. efficiency. Calibration software is one such tool that can be used to support and guide calibration management activities. followed by the selection of suitable calibration methods and tools for execution of these methods.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. it is important to consider the typical calibration management tasks that companies have to undertake. documentation.

calibration labels need to be created and pasted. 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 . which may then have to be scrapped. a safety problem or leading to batches of inferior quality goods being produced. The execution stage involves supervising the assigned calibration tasks. The next calibration tasks then have to be scheduled. ISO 9001:2008 and the FDA both state that calibration records must be maintained and that calibration must be carried out according to written. These intervals may need to be adjusted based on archived calibration history. 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. If. This paperwork typically involves preparing calibration instructions to help field engineers. a sensor drifts out of its specification range. service engineers. Staff carrying out these activities must follow the appropriate instructions before calibrating the device. This means an instrument engineer can spend as much as 50 per cent of his or her time on documentation and paperwork – time that could be better spent on other value-added activities. The calibration is then executed according to the plan. although further instructions may need to be followed after calibration. Based on the calibration results. The effectiveness of calibration needs to be reviewed and calibration intervals checked. Resources then have to be organised and assigned to actually carry out the scheduled calibration tasks. and documenting and archiving calibration data. making notes of calibration results in the field. The next stage. resulting in costly production downtime. organisation. then classified into ‘critical’ and ‘non-critical’ devices. then created documents copied and archived. involves training the company’s calibration staff – typically maintenance technicians. the consequences could be disastrous for the plant. including any associated safety procedures. for example. companies then have to analyse the data to see if any corrective action needs to be taken. process and quality engineers and managers – in using the chosen tools and how to follow the approved SOPs.why use software for calibration management All plant instruments and measurement devices need to be listed. approved procedures.

81 . just under a third of companies (with 500+ employees) typically have more than 5. whilst others used a calibration module within an existing Computerised Maintenance Management System (CMMS).000 calibrations each year. The percentage is still quite high in the food & beverage sector. However. the picture in reality can be very different. different industry sectors have different requirements and regulations.000 instruments that require calibrating. 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. paper-based system. Gas & Petrochemicals is similarly high. Many other companies said that they relied on generic spreadsheets and/or databases for this. 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. However. a massive 75 per cent of companies carry out more than 2. Furthermore. Oil. Only a quarter of companies use calibration software In Beamex’s own Calibration Study carried out recently. but many firms still do this. 40 per cent of companies surveyed said that they calculated calibration intervals by using historical trend analysis – which is encouraging. 42 per cent of companies perform more than 2.000 times every year. with 55 per cent of companies performing more than 2. Noting down calibration results by hand in the field and then transferring these results into a spreadsheet back at the office may seem archaic. A significant proportion (almost 20 per cent) of those surveyed said they used a manual. In the highly regulated pharmaceuticals sector. 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. This equates to a huge amount of paperwork for any process plant. let alone time consuming.000 calibrations per year. where 21 per cent of firms said they calibrated their instruments more than 2. In the Power & Energy sector.why use software for calibration management When it comes to the volume of documentation required. In a recent survey conducted by Control Magazine. Any type of paper-based calibration system will be prone to human error. analysis of paper-based systems and spreadsheets can be almost impossible.000 calibrations each year. many of these firms said they were doing it without any sort of calibration software to assist them. for example.

Furthermore. easier and more accurate analysis of calibration records and identifying historical trends.why use software for calibration management Using software for calibration management enables faster. Instrument ‘drift’ can be monitored closely over a period of time and then decisions taken confidently with respect to amending the calibration interval. paper-based system requires little or no 82 . after which they are archived as paper documents. Companies could save so much time and reduce costs by using calibration management software to analyse historical trends and calibration results. Plants can therefore reduce costs and optimise calibration intervals by reducing calibration frequency when this is possible. by analysing the calibration history of a flow meter that is located in a ‘non-critical’ area of the plant. How to plan and keep track of each instrument’s calibration procedures means that planning and scheduling is important. instrument calibration intervals based on either the manufacturer’s own recommendation. a process plant may find it necessary to increase the frequency of some sensors that are located in a hazardous. Just as important. The number of instruments and the total number of periodic calibrations that these devices require can be several thousand per year. the company may be able to decrease the frequency of calibration. this might include engineers using pens and paper to record calibration results while out in the field. potentially explosive area of the manufacturing plant. Regardless of industry sector. Typically. Neither method is ideal in practice. or by increasing the frequency where necessary. While using a manual. Paper-based systems These systems typically involve hand-written documents. easier and more accurate analysis of calibration records and identifying historical trends. or they used a uniform interval across the plant for all instruments. For example. saving time and resources. these notes are then tidied up or transferred to another paper document. for improved safety. the plant may be able to extend these intervals by looking closely at historical trends provided by calibration management software. Using software for calibration management enables faster. On returning to the office. Rather than rely on the manufacturer’s recommendation for calibration intervals. every instrument calibration has to be documented and these documents need to be easily accessible for audit purposes. there seems to be some general challenges that companies face when it comes to calibration management.

g. This includes the planning and scheduling of calibration work. users are provided with an easy-to-use Windows Explorer-like interface. 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. Also. using an in-house legacy system to manage calibrations has its drawbacks. automatic alarms cannot be set up on instruments that are due for calibration. and Regardless of industry sector.why use software for calibration management investment. but the calibration cannot be automated because the system is not able to communicate with ‘smart’ calibrators. Furthermore. 83 . CMM systems are not designed to manage calibrations and so often only provide the minimum calibration functionality. but the recording of calibration information is still time-consuming and typing errors are common. there seems to be some general challenges that companies face when it comes to calibration management. Calibration software With specialist calibration management software. the level of automation is still low. Although instrument data can be stored and managed efficiently in the plant’s database. In addition. databases. FDA) for managing calibration records. In these systems. the CMM system may not meet the regulatory requirements (e. etc.) Although certainly a step in the right direction. the calibration process itself cannot be automated. it is very labour-intensive and means that historical trend analysis becomes very difficult to carry out. The system is time consuming. the calibration data is not easily accessible. In-house legacy systems (spreadsheets. soaks up a lot of resources and typing errors are commonplace. analysis and optimisation of calibration frequency. For example. In addition. Dual effort and re-keying of calibration data are also significant costs here. such as the scheduling of tasks and entry of calibration results. communication with smart calibrators. certificates and labels. Plant hierarchy and works orders can be stored in the CMM system. production of reports. The data is stored in electronic format. The software manages and stores all instrument and calibration data. calibration data is typically entered manually into a spreadsheet or database.

while automatic alerts for scheduled calibrations can be set up. The Change Management feature in Beamex’s CMX software. The result is a streamlined. These instructions can also be downloaded to a technician’s handheld documenting calibrator while they are in the field. 84 . Calibration instructions are created using the software to guide engineers through the calibration process. Position. Regulatory organisations and standards such as FDA and ISO place demanding requirements on the recording of calibration data. calibration software can facilitate both the preparation and the audit itself. Documentation is also improved. for example. such as Change Management. reports and labels can all be printed out on paper or sent in electronic format. Procedures and calibration strategies can be planned and all calibration assets managed by the software. enabling engineers to optimise calibration intervals using the software’s History Trend function. device and calibrator databases are maintained. The software generates reports automatically and all calibration data is stored in one database rather than multiple disparate systems. Audit Trail and Electronic Signature functions. plant productivity and efficiency. Analysis becomes easier too. Calibration software has many functions that help in meeting these requirements. then automatically uploaded back to the calibration software. automated calibration process. Also. when a plant is being audited. Organisation also improves.why use software for calibration management easy integration with CMM systems such as SAP and Maximo. Using software-based calibration management systems in conjunction with documenting calibrators means that calibration results can be stored in the calibrator’s memory. Locating records and verifying that the system works is effortless when compared to traditional calibration record keeping. complies with FDA requirements. Benefits of using calibration software With software-based calibration management. The system no longer requires pens and paper. which improves quality. planning and decisionmaking are improved. Calibration certificates. Human error is minimised and engineers are freed up to perform more strategic analysis or other important activities. There is no re-keying of calibration results from a notebook to a database or spreadsheet. easier and more accurate analysis of calibration records and identifying historical trends. Using software for calibration management enables faster. Execution is more efficient and errors are eliminated.

For example. The integration will save time. as the entire calibration process is now streamlined and automated. Beamex CMX Professional is ideal. multilingual users and a very large amount of instruments that require calibration. where calibration data is needed for only one location. with no manual documentation procedures. only a few instruments require calibrating and where regulatory compliance is minimal. If the plant instruments are already defined on a database. validated processes. Costly production downtime will also be reduced. 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. Beamex’s high-end solution. those instruments that perform better than expected may well justify a reduction in their calibration frequency. as well as strict regulatory compliance. the calibration management software can utilise the records available in the CMM system database. calibration management software can be easily integrated to this system. implementing software-based calibration management means overall costs will be reduced. which simply is not possible with a standalone CMM system. For medium-to-large sized companies that have multiple users who have to deal with a large amount of instruments and calibration work. 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 . reduce costs and increase productivity by preventing unnecessary double effort and re-keying of works orders in multiple systems. These savings come from the now-paperless calibration process. a central calibration management database is often implemented that is used by multiple plants across the world. which is particularly beneficial if the company is replacing a lot of labour-intensive calibration activities. Benefits for all process plants Beamex’s suite of calibration management software can benefit all sizes of process plant. is suitable for process manufacturers with multiple global sites. implementation.Business benefits For the business. Engineers can analyse calibration results to see whether the calibration intervals on plant instruments can be altered. Manual procedures are replaced with automated. Even if a plant has already implemented a CMM system. For relatively small plants. Plant efficiencies should also improve. Here. Beamex CMX Light is the most appropriate software. CMX Enterprise. Integration also enables the plant to automate its calibration management with smart calibrators.

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. The results showed that 82% of CMX Calibration software customers said that using Beamex products had resulted in cost savings in some part of their operations. Despite these benefits. increased productivity and reduced costs of the entire calibration process. in-house built legacy calibration systems or calibration modules with CMM systems. across all industry sectors. whilst 92% said that using CMX had improved the quality of their calibration system. can benefit from implementing specialist calibration management software. paper-based systems. regardless of industry sector. The business benefits of using software for calibration management •  Cost reduction •  Quality improvements •  Increase in efficiency 86 . 94% of CMX users stated that using Beamex products had improved the efficiency of their calibration processes. Compared to traditional. Summary Every type of process plant. using dedicated calibration management software results in improved quality. only one quarter of companies who need to manage instrument calibrations actually use software designed for that purpose.

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a plant is able to define which instruments can be calibrated less frequently and which should be calibrated more frequently. Plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’.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. Most process manufacturing plants will have some sort of maintenance plan or schedule in place. the time and resources required to carry out these calibration checks are often scarce. the consequences can be disastrous for a plant. which ensures that all instruments used across the site are calibrated at the appropriate times. with those deemed critical enough receiving the required regular checks. pressure transducers. However. Calibration history trend analysis is only possible with calibration software that provides this functionality. flow meters and the like – are performing and measuring to specified tolerances. By doing it. 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. This can sometimes lead to instruments being prioritised for calibration. resulting in costly production downtime. safety issues or possibly leading to batches of inferior quality goods being produced. a function available within Beamex® CMX calibration software. which then have to be scrapped. being calibrated less frequently or not at all. 89 . but for other sensors that are deemed less critical to production. with increasing demands and cost issues being placed on manufacturers these days.

paper and pulp. chemicals. Perhaps unsurprisingly. the plant can analyze whether it should increase or decrease the calibration frequency for all its instruments. is only possible with calibration software that provides this type of functionality. drifts in and out of tolerance over a given time period. The survey covered all industry sectors. Cost savings can be achieved in several ways. But plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’. service. Current practices in process plants But in reality. manufacturing. Second. 90 . In addition. oil and gas. First. in the pharmaceuticals sector. However. With this function. for example. 56% of the respondents said they calibrated their instruments no more than once a year. including pharmaceuticals. This type of practise is common in companies that employ an effective ‘Preventive Maintenance’ regime. the study proved also that the pharmaceuticals sector typically possesses a significantly higher number of instruments per plant that require calibrating. The analyses of historical trends and how a pressure sensor. a function available within Beamex® CMX calibration software. the survey showed that from all industry sectors. 59% said they calibrated once a year and 30% said they calibrated twice a year. by calibrating less frequently where instruments appear to be highly stable according to their calibration history. due to it being a highly regulated industry. Interestingly. by calibrating instruments more often when they are located in critical areas of the plant. power and energy. 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. 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.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. ensuring that instruments are checked and corrected before they drift out of tolerance. food and beverage. these plants also calibrate their instruments more frequently than other industry sectors.

But there are other. or even years of operation and which can be left for longer periods. without doubt. Sensors that are found to be highly stable do not need to be re-calibrated as often as sensors that tend to drift. Pertti Mäki is Area Sales Manager at Beamex. As Mäki explains: “When an engineer buys a particular sensor. The function enables users to plan the optimal calibration intervals for their instruments. 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. which helps companies identify the optimal calibration intervals for instruments. weeks. is determining which sensors should be recalibrated after a few days. says Mäki.” The trick. but all industry sectors can benefit from using the software tool. Doing this. by analysing an instrument’s drift over time (ie. 91 . without of course sacrificing the quality of the product or process or the safety of the plant and its employees. He comments: “The largest savings from using the History Trend Option are in the pharmaceuticals sector. the historical trend) companies can reduce costs and improve their efficiencies. enables maintenance staff to concentrate their efforts only where they are needed. If it hasn’t. therefore eliminating unnecessary calibration effort and time. he says. Calibration software such as CMX can also help with the planning of calibration operations. This makes it an invaluable tool for maintenance or quality personnel who. the engineer now has data to present to the supplier to support his findings. actually performed within the specified tolerance over a certain time period. the supplier provides a technical specification that includes details on what the maximum drift of that sensor should be over a given time period. perhaps less obvious benefits of looking at the historical drift over time of a particular sensor or set of measuring instruments.” But that’s not all. 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. With CMX’s History Trend Option.how often should instruments be calibrated The benefits of analyzing calibration history trends But regardless of the industry sector. He specialises in selling the Beamex® CMX to different customers across all industry sectors. The History Trend function also means that a plant can now compare the quality or performance of different sensors from multiple manufacturers in a given location or set of process conditions. the engineer can now verify that the sensor he or she has purchased.

using the ‘Report Design’ tool option. The ‘History Trend’ window enables users to view key figures of several calibration events simultaneously. Also. can analyze an instrument’s drift over a certain time period. maintenance personnel. 92 . for example. For example. allowing to evaluate the calibrations of a position or a device for a longer time period compared to the normal calibration result view. the engineer can analyze how different devices are suited for use in a particular area of the plant or process.how often should instruments be calibrated History Trend displays the instrument’s drift over a given period both numerically and graphically. Once implemented. The History Trend function enables users to plan the optimal calibration intervals for their instruments. Based on this information. it is then possible to make decisions and conclusions regarding the optimal calibration interval and the quality of the instruments with respect to measurement performance. the user can get an overview of how a particular device drifts between calibrations and also whether the drift increases with time. History Trend displays the instrument’s drift over a given period both numerically and graphically. Reporting is straightforward and the user can even tailor the reports to suit his or her individual needs.

the history trend is made automatically without any extra manual work.how often should instruments be calibrated CALIBRATION HISTORY TREND ANALYSIS Calibration history trend analysis allows you to analyze the instrument’s drift over a certain time period. •  The Beamex® CMX also indicates when new devices have been installed and calibrated. •  The Beamex® CMX stores every calibration event into the database. •  The graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments. HISTORY TREND REPORT HISTORY TREND USER-INTERFACE The graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments. 93 . This helps in comparing differences between devices.

manual methods •  Enables engineers to check that the instruments they have purchased for the plant are performing to their technical specifications and are not drifting out of tolerance regularly •  Supplier evaluation: the performance and quality of different sensors from different manufacturers can be compared quickly and easily.how often should instruments be calibrated SUMMARY The benefits of calibration history trend analysis: •  Analyzing and determining the optimal calibration interval for instruments •  Conclusions can be made regarding the quality of a particular measuring instrument •  Time savings: faster analyses is possible when compared to traditional. When calibration frequency can be decreased: •  If the instrument has performed to specification and the drift has been insignificant compared to its specified tolerance •  If the instrument is deemed to be non-critical or in a low priority location When calibration frequency should be increased: •  If the sensor has drifted outside of its specified tolerances during a given time period •  If the sensor is located in a critical process or area of the plant and has drifted significantly compared to its specified tolerance over a given time period •  When measuring a sensor that is located in an area of the plant that has high economic importance for the plant •  Where costly production downtime may occur as a result of a ‘faulty’ sensor •  Where a false measurement from a sensor could lead to inferior quality batches or a safety issue 94 .

When used in the monitoring and measurement of specified requirements. measuring equipment shall a)  be calibrated or verified at specified intervals. the ability of computer software to satisfy the intended application shall be confirmed. 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. e)  be protected from damage and deterioration during handling. 95 . where no such standards exist. the basis used for calibration or verification shall be recorded. The organization shall take appropriate action on the equipment and any product affected. maintenance and storage.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. Records of the results of calibration and verification shall be maintained (see 4. This shall be undertaken prior to initial use and reconfirmed as necessary.4). b)  be adjusted or re-adjusted as necessary. against measurement standards traceable to international or national measurement standards. In addition. c)  be identified to enable the calibration status to be determined. the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. Where necessary to ensure valid results.2. d)  be safeguarded from adjustments that would invalidate the measurement result.how often should instruments be calibrated ISO 9001:2008 quality management requirements 7. or prior to use.

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how often should calibrators be calibrated

How often should calibrators be calibrated

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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.

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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

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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.

SUMMARY

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.

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especially given that there are technologies. Traditional paper-based calibration systems Typically. which means they are missing out on the benefits of moving towards a paperless calibration system. As manufacturing companies. software and electronic devices readily available today which render the use of paper in the workplace unnecessary. our consumption of paper is far higher than it needs to be. 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. significant benefits in minimising the use of paper. weighing instruments and pressure transducers. as businesses. Today. Global consumption of paper has grown 400% in the last 40 years. Far too many of these companies still use paper-based calibration systems. printer paper. perhaps even a poster on the wall. Other than helping to save our planet and reducing the number of trees cut down each year. calibrating instruments is an enormous task that consumes vast amounts of paperwork. amongst the process manufacturing industries. Globally. So let’s not add to this already heavy burden on our forests and the environment.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. a maintenance or service Far too many of these companies still use paper-based calibration systems. ecology. there are other. Take a minute to look around the room you are in and you’ll notice how many objects are made from paper: books.com). Whilst out in the field. magazines. 101 . a paper-based calibration system involves the use of handwritten documents. Take the calibration of plant instrumentation devices such as temperature sensors. which means they are missing out on the benefits of moving towards a paperless calibration system.

In addition. Furthermore. Paper systems are time consuming. it is not practicable to store or carry lots of paperwork. paper records that need approval have to be routed to several individuals. paper-based system requires little or no investment in new technology or IT systems. as those individuals who need to sign off records or calibration 102 . Dual effort and the re-keying of calibration data into multiple databases become significant costs to the business. On returning to the office. blank calibration certificates. after which they are archived as paper documents. Practical benefits of using less paper Aside from the financial benefits of moving towards a paperless calibration system. whilst also improving quality. standard operating procedures (SOPs). workflow improves dramatically. when these records can all be combined into a single electronic record? Improved workflow With paper-based systems. it is extremely labourintensive and means that historical trend analysis of calibration results becomes very difficult.paperless calibration improves quality and cuts costs With paperless systems. these notes are then tidied up and/or transferred to another paper document. they soak up lots of company resources and manual (typing) errors are commonplace. workflow and making other significant cost savings for the business. Often. workflow improves dramatically. in industrial environments. engineer will typically use a pen and paper to record instrument calibration results. by utilising the latest software-based calibration management systems from companies like Beamex. After all. every square foot of the business has an associated cost. However. important paper records could potentially be lost or damaged in an accident or fire. which is time-consuming. These same companies that use paper-based calibration systems are together generating hundreds of thousands (millions?) of paper calibration certificates each year. With paperless systems. accessing calibration data quickly is not easy. So why would these companies generate and store separate paper copies of important records such as works orders. There will be less waiting time. there are practical reasons why firms should go paperless. etc. While using a manual. these organisations can significantly reduce their paper consumption.

Business benefits For those more enlightened companies that use software-based calibration systems. the business benefits are significant. When a plant is being audited. 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. which again has cost reduction benefits to the business. as well as the cost of filing and storing those paper records. Calibration intervals can be optimised. particularly calibration results. particularly when using weighscales or other instruments that are open to an individual’s own interpretation of the data. Just as important. Paper records may not always reflect the truth. Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. those instruments that are performing better than expected may well justify a reduction in their calibration frequency.paperless calibration improves quality and cuts costs documents can share or access electronic records simultaneously from a central database. engineers and management will have more confidence in Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. Illegible handwritten notes are also a problem. electronic records enable easier analysis of data. Locating records and verifying that the system works becomes effortless when compared to traditional paper-based record keeping. faster and more reliable. manual errors such as misreadings can occur. Sometimes users may inappropriately modify the results data due to work pressures or lack of time/resources. whilst mistakes and manual errors will be virtually eliminated. In turn. Historical trending becomes easier. The whole calibration process – from initial recording of calibration data through to historical trend analysis – will take less time. For example. calibration software facilitates both the preparation and the audit itself. especially if these paper records need to be typed or transcribed to a computer system or database. this means that operators. 103 . The cost and time associated with printing copies of paper documents is also eliminated. For example. Costly production downtime due to unforeseen instrument failures will also be reduced. Data integrity The integrity of paper-based calibration systems cannot be relied upon.

many companies are neither completely paperless nor rely solely on paper-based systems – the process is sometimes a hybrid of the two. resulting in completely paperless. electronic records simplify the handover of plant and equipment. In other words. The calibration data is shared with other business IT systems electronically. 104 . 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. Companies can go even further than this and use electronic records for works orders. The un-editable electronic data stored on high performance multifunction calibrators can be uploaded to calibration management software for safe storage and asset management. technician friendly interfaces on industrialized PDA or tablet based hardware when manual data entry cannot be avoided. resulting in completely paperless. end-to-end workflows. Although handover by commissioning teams that use paper records is straightforward and of universal format. data historians. and the manual entry of calibration results into unintelligent calibration forms on portable industrial computers prone to eye-to-hand data mis-reads and repetitive strain induced error. in reality. particularly when it comes to plant audits. In addition. electronic records are easy to manipulate and can be re-used in different IT systems. without needing to collect all the plant data again. 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.paperless calibration improves quality and cuts costs the data. and for control systems. increased efficiencies and reduced plant downtime. the calibration data is shared with other business IT systems electronically. How paperless should you go? Of course. business management systems. Commissioning At plant commissioning times. end-to-end workflows. Electronic data also provides an excellent foundation for ongoing plant operation and maintenance. A key part of paperless calibration records is the capture of data at point of work. often in difficult industrial environments that would make the use of portable office computers impractical.

training & education Paperless systems also need validating in the user’s own environment.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. as well as the sensors that monitor the incoming chemical additives and the outgoing effluent. as this will help companies to overcome the natural resistance to change amongst the workforce. Based in East Yorkshire near Goole. easier and more accurate than our old paper-based procedures. Case study Beamex is helping many organisations to implement paperless calibration management systems. “It’s saving us around 80 manhours per maintenance period and should pay for itself in less than three years.” Education and training for users is critical. Beamex provides comprehensive validation. This includes a functionality check on all of the pressure instrumentation. which may be used to dealing with traditional. 105 . which coordinates data collection tasks and archives the results. paper-based systems. as this will help companies to overcome the natural resistance to change amongst the workforce. it is better to source the data electronically using documenting calibrators that are specifically designed for this task. 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. Croda uses the CMX calibration management software system from Beamex. the Croda plant uses pressurised vessels to purify lanolin for healthcare and beauty products. Here. which may be used to dealing with traditional.” says Wright. Education and training for users is critical. Oil Gas & Petrochemicals companies. Power & Energy. Chemicals. Amongst these customers is UK firm Croda Chemicals Europe. education and training services for customers. paper-based systems. including Pharmaceuticals. Each vessel needs to be certified at least once every two years in order to demonstrate that the vessel is safe and structurally sound. “It’s faster. Validation.” Today.

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intelligent commissioning Intelligent commissioning C alibration plays a vital role in process plant commissioning and when installing new instruments. At the completion of commissioning. Successful commissioning of process instrumentation is an essential requirement for ideal plant performance. These activities are usually described as ‘cold commissioning’. 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. Energizing power systems. is ready for commissioning when the plant has achieved mechanical completion. operational testing of plant equipment. the plant will be fully ready for production operation. This article explains process instrument commissioning and the benefits of calibration during the commissioning phase. Commissioning may involve mock operations which are commissioning activities conducted to allow operational testing of the equipment and operator training and familiarization. What is process instrument commissioning? Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. A plant. Pre-commissioning activities are those which have to be undertaken 107 . In general. 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. testing of the control systems as well as verification of the operation of all interlocks and other safety systems are also typical commissioning tasks. or any defined part of a plant. calibration of instrumentation.

Each of the commissioning activities must be broken down into a number of manageable tasks. plant operation and plant maintenance. 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. as the plant owner’s commitments in terms of product marketing and operational costs are likely to be higher. 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. As there are many cost factors in the commissioning process. configuring the required parameters and testing the configuration and interface to other systems. physically installing the field device. Basically. The cost of process instrument commissioning is typically affected by the following issues: learning and familiarizing with the field device. Commissioning requires a team of people with a background in plant design. personnel and cost of commissioning Since commissioning takes place toward the end of the project. connecting to and identifying the field device. prior to operating equipment. these steps must be repeated with every field device that will be installed at the plant. The rate 108 . there is a risk that the work may be under-resourced. It is essential to comprehend the scope and length of commissioning activities and include them in the initial project plan and budget allocations. This can prove to be a worthwhile investment for large plants because it allows for dedicated responsibility and focus in operations and significant improvements to schedules. and a schedule needs to be established for each task including benchmarks for monitoring purposes. Some companies employ specialized commissioning engineers.intelligent commissioning There are many reasons why instruments should be calibrated during the commissioning phase before start-up. Management. because the funds have been allotted to cover budget overruns. and ensure this commitment is maintained. and adverse incidents at the start-up phase can be avoided. 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. in fact. detailed planning of commissioning and plant handover are essential elements of the overall project plan and schedule as any other grouping of activities.

number of loops or sequence of steps tested per day). However. of commissioning is measurable (e. Good planning. teamwork and training are all essential. Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. such as the Beamex® CMX Calibration Software. Calibration and the commissioning of field instrumentation New process instrumentation is typically configured and calibrated by the manufacturer prior to installation.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. Sequence of activities leading to commissioning and acceptance of a plant. especially if there has been obvious 109 . instruments are often recalibrated upon arrival at the site. thereby enabling progress to be reviewed regularly. and the size of the team and composition of specialists depends on the nature and scope of the system. documentation. coordination. instrument and process engineers. communications. The commissioning team consists of a mixture of specialists.g.

it is possible to monitor the stability of the transmitter. weeks. The transmitter information is critical in defining the quality of the instrument and for planning the optimal calibration interval of the instrument. or years of operation and which can be left as is for 110 . After you have performed this task. Monitoring the quality and stability of a transmitter When calibration procedures are performed for an uninstalled instrument. when the initial planned specifications have been changed. as was explained in the previous paragraph. or years of operation and which can be left as is for longer periods without sacrificing quality or safety. The new uninstalled instrument or transmitter may have the correct.intelligent commissioning damage in transit or storage. it is possible to reconfigure the transmitter. The trick is determining which sensors should be recalibrated after a few hours. There are also many other reasons why instruments should be calibrated during the commissioning phase before start-up. The calibration database can be calibration software designed specifically for managing calibration assets and information. weeks. 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. By calibrating the transmitter before installation and on a regular basis thereafter. Assuring transmitter quality First of all. it is possible that the original planned settings are not valid anymore and they need to be changed. Calibrating a new instrument before installing or using it is a quality assurance task. However. Reconfiguring a transmitter The trick is determining which sensors should be recalibrated after a few hours. the fact that an instrument or transmitter is new does not automatically mean that it is within required specifications. the calibration serves also future purposes. specified settings. as well as to monitor the instrument’s stability. You can check the overall quality of the instrument to see if it is defective and to ensure it has the correct. specified settings. 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. 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.

thereby eliminating unnecessary calibration work. overlooked or become overdue. making the entire process much quicker and reducing costs.intelligent commissioning longer periods without sacrificing quality or safety. The Beamex calibrators are all-in-one calibrators. for instance. Using the CMX gives always a clear status of the transmitters. such as analog. smarter and more accurate management of all calibration assets and procedures. The Beamex® CMX can be used for planning and scheduling calibrations. The Beamex® CMX Calibration Software can be used for improving the quality. By using a documenting calibrator. HART. the calibration results are stored automatically in the calibrator’s memory during the calibration process. 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. are they installed and ready for calibration. consisting of calibration software and documenting calibration equipment. 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. Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important. The Beamex calibrators support various different transmitter protocols. overlooked or become overdue. Intrinsically safe calibrators for potentially explosive environments are also available. temperature. productivity and cost-effectiveness of a plant’s calibration process. managing and storing all calibration data as well as analyzing and optimizing the calibration interval. Integrated calibration solution by Beamex The Beamex® Integrated Calibration Solution. Foundation Fieldbus and Profibus. Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks do not get forgotten. improves the quality and efficiency of the entire calibration system through faster. 111 . Doing so allows maintenance personnel to concentrate their efforts only where needed. The Beamex® MC series documenting calibrators can be used for calibrating pressure. which mean that they can be used to replace several individual measurement devices. Engineers performing calibrations no longer have to write down any results on paper. electrical and frequency signals. Therefore. does anyone perform the calibration (check in/out function) and what is the instrument/position status (pass/fail).

the calibration results are stored automatically in the calibrator’s memory during the calibration process. again. therefore automatically produced when using the Beamex® Integrated Calibration Solution. The calibration results are transferred automatically from the calibrator’s memory to the computer/ database. saving time and money. Major time-savings can also be achieved by using Beamex’s documenting MC calibrators HART and/or Fieldbus functionality to enter transmitter data into the calibrators’ memory where the data can be populated to the CMX Calibration Software.intelligent commissioning By using a documenting calibrator. SUMMARY Calibration is beneficial during process plant commissioning for various different reasons: • Transmitter quality assurance • Reconfiguring a transmitter • Monitoring the quality and stability of a transmitter •  Entering the necessary transmitter data into a calibration database and defining the optimal calibration interval 112 . instead of typing the data manually into the calibration database. as there are fewer mistakes due to human error. The quality and accuracy of calibration results also improve. This means that engineers do not spend their time transferring the results from their notepad to final storage on a computer.

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where equipment and plant infrastructure is large. especially if the company is part of an asset-intensive industry. conveyor systems or hydraulic pumps – is equally critical for these companies. oil and gas. 115 . profitability and growth. Maintaining plant assets – whether that includes production line equipment. seamlessly integrated set of IT systems across the plant. Maintenance management has become an issue which deserves enterprise-wide and perhaps multi-site attention. but critical part of a company’s asset management strategy should be the calibration of process instrumentation. metal processing. complex and expensive. For this. If stoppages to production lines due to equipment breakdowns are costly. special purpose machines. or across multiple sites. safety issues or batches of inferior quality goods being produced. is critical to business efficiency. but critical part of a company’s asset management strategy should be the calibration of process instrumentation. Beamex® CMX. flow meters and the like – are performing and measuring to specified tolerances. boilers. which then have to be scrapped. pressure transducers. In the process industries. Beamex’s calibration management software. furnaces. chemicals. a small. Manufacturing plants need to be sure that their instrumentation products – temperature sensors. nuclear.successfully executing a system integration project Successfully executing a system integration project F or process manufacturers today. a small. the consequences can be disastrous. implementing the latest computerized maintenance management systems (CMMS) might save precious time and money. paper. having a reliable. In the process industries. If sensors drift out of their specification range. has proved itself time and time again across many industry sectors. perhaps resulting in costly production downtime. including pharmaceuticals.

CMX sends an acknowledgement order of this work back to the customer’s CMM system. elimination of human error associated with manual recording. A data exchange module or interface that sits between the two systems is required. Seamless communication between CMX and ‘smart’ calibrators means that companies have the ability to automate predefined calibration procedures. and the ability to speed up the calibration task. CMX can also download detailed instructions for operation before and after calibrating. Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems. Integration project A customer may have a large CMM system and a considerable amount of data keying to perform before integration is complete. Calibration work orders can easily be transferred to CMX Calibration Software. The integration project involves three main parties: Beamex. plan. As well as retrieving and storing calibration data. 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. analyze and optimize their calibration work. All detailed calibration results are stored and available on the CMX database. in-house software for maintenance management. most process manufacturers use some sort of computerized maintenance management system (CMMS) that sits alongside their calibration management system.successfully executing a system integration project Seamless communication Today. reminders and safety-related information. Then. Seamless communication with calibrators also provides many practical benefits such as a reduction in paperwork. Beamex® CMX helps companies document. like procedures. 116 . CMX also stores the complete calibration history of process instruments and produces fully traceable calibration records. once the calibration work order has been executed. SAP or Datastream CMM system or even a company’s own. in-house software for maintenance management. Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems. SAP or Datastream CMM system or even a company’s own. whether it is a Maximo. the customer and the CMM system software partner. whether it is a Maximo. schedule.

it’s important that the right people and decision-makers are involved and participate right from the beginning of the project. A schedule is usually defined for the completion of the entire project as well as for the completion of each project phase. It’s also essential that the main roles and responsibilities of the parties are specified before the project evolves. the customer and the CMM system software partner. The role of each member should be defined and project managers appointed. Moreover. Development and Implementation 3. 117 . The role. a project steering group may need to be established. Installation. Scope of Work 2. In addition. Verification and Training The four main phases are also often divided into sub-phases. agreement.successfully executing a system integration project Project organization and resourcing In order to have a successful integration. The integration project involves three main parties: Beamex. tasks and authority of the project steering group must be defined as well as the decision-making procedures. as a successful project requires input from both parties. Project phases The integration project is divided into four main phases: 1. The project steering group is responsible for making key decisions during the project. project plan or other document annexed to the offer / agreement. Each project phase should be approved according to the acceptance procedures defined in the offer. Testing 4. The project manager is usually responsible for the operative management of the project. a project organization should be established and include members from both the supplier’s and the customer’s organization.

main roles. The SOW is often developed through pre-studies and workshops. it is important that the supplier and customer agree on change management procedures as early as the starting phase of the project. The scope of work should include a brief project description. as the resourcing. 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. Defining what is not included in the scope of work is just as important as defining what is included in it. questions or problems may appear later in the project. services provided. If the scope of work is not defined carefully. as changes to the original scope of work may be necessary and required even in projects where the SOW phase has been done carefully. 118 . partner responsibilities and the desired outcome. scheduling and costs of the project depend greatly on the scope of work. which will direct the project back to phase one where a review of the scope is necessary. 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. However.successfully executing a system integration project Scope of work To ensure successful integration with a satisfied customer. This means that establishing some framework and limitations for the project are also very important. defining the correct scope of work (SOW) is crucial.

training and providing training materials. in order to be able to continue the development work to next phase. the customer has a system that saves time. Installation. the customer has a system that saves time. When the integration is finished. reduces costs and increases productivity by preventing unnecessary double effort and rekeying of procedures in separate systems. Testing Testing occurs both during the project after each partial delivery. assist with informing.successfully executing a system integration project Development and implementation When the scope of work has been defined and approved by both parties. which is the actual development and implementation of the project deliverables. 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. approval procedures and timelines should be defined when agreeing on the project. The supplier will. if required and agreed. • 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 project manager at the buyer’s facility now plays a major role in the success of the integration process. The testing. the integration can enter the next phase. 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. and at the final stage of the project.

This improves the quality of the entire system. 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. But the key to success is really the quality of information you put in the software. better management of spare parts and equipment stocks. the data has to be as close to 100% accurate as possible to get maximum benefit from the system. a corresponding increase in asset utilization or plant uptime. However. 120 . EAM is more than just maintenance management software. Integrating a CMM system with calibration management software is an important step in the right direction when it comes to EAM. typing errors are eliminated. Savings from EAM are reasonably well-documented and come in various guises. particularly with production teams. Enterprise Asset Management. When there is no need to manually re-key the data.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. A CMMS integration will enable the customer company to automate its’ management with smart calibrators. and optimized scheduling of maintenance tasks and resources. the most common benefits being: less equipment breakdowns (leading to a reduction in overall plant downtime). systems. Enterprise Asset Management. more efficient use of maintenance staff.

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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 key final step in any calibration process – documentation – is often neglected or overlooked because of a lack of resources. The purpose of calibration itself is to determine how accurate an instrument or sensor is. Foundation Fieldbus or Profibus output of the transmitters and can even be used for configuring ‘smart’ sensors. However. and then automatically documenting the calibration results by transferring them to a fully integrated calibration management software. calibration every six months – or even more frequently – is not unusual. temperature and electrical signals. In plant areas where instrument accuracy is critical to ensure product quality. safety or custody transfer. including frequency and pulses.the benefits of using a documenting calibrator The benefits of using a documenting calibrator F   or process manufacturers. Indeed. regular calibration of instruments throughout a manufacturing plant is common practice. 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. 125 . time constraints or the pressure of everyday activities. 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. Although most instruments are very accurate these days. 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. Some calibrators can read HART.

” With a multi-functioning documenting calibrator. Product Manager at Beamex in Finland comments. With instrument calibration. Calibration results have to be keyed manually into a separate database. 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. Performing the calibration procedure in the same way each time is important for the consistency of results. The engineer does not have to write any results down on paper. again. By using a documenting calibrator.the benefits of using a documenting calibrator Heikki Laurila. “Engineers. spreadsheet or paper filling system. Why use a documenting calibrator? The engineer does not have to write any results down on paper. This means the engineer does not have to spend time transferring the results from his notepad to final storage on a computer. who are out in the field performing instrument calibrations. as well as detailed instructions on how to calibrate the transmitter.” A non-documenting calibrator is a device that does not store data. the calibration procedure itself is critical. the calibration results are stored automatically in the calibrator’s memory during the calibration process. 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. which makes the entire process much faster and consequently reduces costs. but which also integrates and automatically transfers this information to some sort of calibration management software. which makes the entire process much faster and consequently reduces costs. The calibration results are automatically transferred from the calibrator’s memory to the computer/database. especially if calibration is one of the many tasks that the user has to carry out in his daily maintenance routine. as there will be fewer mistakes due to human error. Also. The tolerances and limits for a sensor. having an easy-touse documenting calibrator is definitely the way forward. As Laurila states. the calibration procedure can be automatically transferred from the computer to the handheld calibrator before going out into the field. are entered once into the calibration management software and then downloaded to the calibrator. receive instant pass or fail messages with a documenting calibrator. such as the 126 . The quality and accuracy of calibration results will also improve. With a documenting calibrator.

Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. configure and trim HART. Benefits in practice Conventional calibration work relies on manual. the field engineer calibrates the instrument. the user can download calibration instructions for hundreds of different instruments into the device’s memory before going out into the field. Foundation Fieldbus H1 or Profibus PA transmitters. Laurila continues.* Why? Because the devices provide higher accuracy. speed and accuracy are critical. Unintentional errors often occur and the whole process is timeconsuming. overlooked or overdue. Manual calibration takes more time and is more prone to error. This means the user can work in the field for several days. January. handwrites the results onto a paper form and then reenters this information into a database when he returns to the office. and the system provides full traceability. 2004 Calibration software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. Both calibrators can be used also to calibrate. the user doesn’t need to carry as much equipment while out in the field. typically with five-point checks on each instrument. Oftentimes. 127 . ___________________ * Reported to the Industrial Instrumentation and Controls Technology Alliance and presented at the TAMU ISA Symposium. “With a documenting calibrator. the calibration process is much faster. paper-based systems for documenting. overlooked or overdue.” Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important. 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 % . When you’ve got to calibrate instruments throughout a site. 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. such as the MC5 or the MC6.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.

•  Less paperwork and fewer manual errors. consistency and quality of calibration results. •  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.the benefits of using a documenting calibrator After completing instrument calibrations. •  The calibration procedure itself is guided by the calibrator. 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. •  Calibration results are automatically stored in the calibrator’s on-board memory during the calibration procedure. •  Improved accuracy. 128 . This not only ensures full traceability but also reflects full and traceable documentation of the completed work. •  Calibration results are automatically transferred from the calibrator’s memory to a computer or fully integrated calibration management system. •  A fully traceable calibration system for the entire plant. the system provides a full quality assurance report of all instruments calibrated along with a required calibration certificate. again.

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and the user must have the knowledge to apply the information achieved through calibration. usually called scales or balances. for example when invoicing is based on the weight of a solid material. 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. 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 of weighing instruments  part 1 Calibration of weighing instruments Part 1 F rom the point of view of the owner. (S)He must select the weighing instrument and maintenance procedure to be used to reach the required measurement capability. Using weighing instruments for legal purposes must have legal verification. the user must define the measurement capability of it. If a weighing instrument is used in a quality system. How the weighing instrument is used and how reliable the weighing results are can be very different. whereas verification depicts the In any case. Calibration depicts the deviation between indication and reference (standard) including tolerance. weighing instruments. The features may vary slightly from country to country. but in the EU they are the same. 131 . at least at the stage when the weighing instrument is being introduced into use. In any case. Verification and calibration abide by a different philosophy. should provide the correct weighing results. the quality of a weighing instrument is already defined in OIML regulations. From a regulatory point of view. Calibration is a means for the user to obtain evidence of the quality of weighing results. Calibration and legal verification Weighing instruments may also possess special features. One of these features includes making measurements for which legal verification is required. at least in Europe.

as long as legal verification is not needed. Using a calibration program. eccentric load. produces a calibration certificate – is the best way to achieve reliable information to use in comparisons. However. this means investigating the efficiency of the weighing instrument. which goes through the same steps for every calibration – calculates deviation and measuring tolerance. including information for other measuring devices. and for weighing technology in general. if necessary. even if it was a question of general weighing (non-legal). One calibration provides information on a temporary basis and a series of calibrations provides time-dependent information. and it displays the history of calibrations and in this way provides the user with comprehensive information concerning measuring capability. The terminology and practices used previously for verifying measurement capability. The practical work for both methods is very similar and both methods can be used to confirm measurement capability. and. 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. etc. we need more information about the weighing instrument. 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. In practice. such as repeatability. We must remember that the quality of the evaluation of measuring tolerance depends on the collected information through calibration. to be able to define the measuring tolerance. This is a feasible practice for all weighing. are based on these practices of calibrating and verifying. 132 . The method of calibration should be selected such that it provides sufficient information for evaluating the required measuring tolerance. this operation is known as calibration (or verification).calibration of weighing instruments  part 1 maximum permissible amount of errors of the indication. Comparing the indication of weighing instruments with a set standard gives the deviation or error. This type of program is able to store all the history of calibrated weighing instruments. Confirming the capability of weighing instruments should happen by estimating the quality of the measuring device in the place where it will be used. It is also handy for monitoring measuring systems. hysteresis. The method should be precise for achieving comparable results during all calibrations.

However. Today. It is very important that the users of the weighing instruments. Calibration itself. If these values are exceeded. it is important to always have the manual for using the weighing instrument easily available to the user. are familiar with these parameters and use them as protocol. as well as many other instruments. as well as calibration personnel. They possess several possibilities for adjusting parameters in measuring procedures. 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. Since there are several parameters in use. however. is a short-term process. is based on microprocessors. the user must determine all of the external factors which may influence the proper functioning of the weighing instrument.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. 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. regular monitoring of the zero point and the indication number with a constant mass. Performing calibrations based on the measuring tolerance is better than doing routine measuring. Therefore. is a short-term process. For this reason. the function of weighing instruments. the idea is that the weighing instrument remains in good working condition until the next calibration. however. The user must define the limits for permitted deviation from a true value and required measuring tolerance. Calibration should be carried out using settings based on the parameters for normal use. Calibration itself. an adjustment or maintenance is necessary. the idea is that the weighing instrument remains in good working condition until the next calibration. the user must evaluate the process of measuring tolerance and compare this value with the required measuring tolerance of the process. 133 . 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. a quality system is usually concerned with the traceability of measurements and the known measuring tolerance of the measurements made.

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.calibration of weighing instruments  part 1 SUMMARY Calibration (or verification) is a fundamental tool for maintaining a measuring system. It also assists the user in obtaining the required quality of measurements in a process.

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industries and households. often need to know just how inaccurate a particular scale may be. Typical scale calibration involves weighing various standard weights in three separate tests: •  repeatability test •  eccentricity test •  weighing test (test for errors of indication) In the pharmaceutical industry in the United States. the equipment was tested or calibrated on a regular basis. but users.calibration of weighing instruments  part 11 Calibration of weighing instruments Part 2 W eighing is a common form of measurement in commerce. If you weigh the object Weighing instruments are often highly accurate. their customers and/or regulatory bodies. Originally. Weighing instruments are often highly accurate.e. tests for determining minimum weighing capability are also performed. Subsequently.and/or industry-specific guidelines or regulations. Repeated weighing measurements provide different indications Usually. and published by the European Collaboration in Measurement and Standards (euromet). i. One clear and thorough guide is the EA-10/18. their customers and/or regulatory bodies. this information was obtained by classifying and verifying the equipment for type approval. often need to know just how inaccurate a particular scale may be. but users. the object being weighed is placed on the load receptor and the weighing result is read only once. i. Typical calibration procedures Calibrating scales involves several different procedures depending on national. 137 . which was prepared by the European Co-operation for Accreditation. or on the potential consequences of erroneous weighing results.e. Guidelines on the Calibration of Non-automatic Weighing Instruments.

Substitution mass should also be used if the construction of the scale does not allow the use of standard weights.73%.g. If the scale’s maximum load limit is extremely large. i.e. Center of gravity matters The eccentricity test involves placing the object being weighed in the middle of the load receptor as accurately as possible. their customers and/or regulatory bodies.1% of the weight. The repeatability test involves weighing an object several times to determine the repeatability of the scale used. This condition is met if the measurement error is less than 0. you will notice slight. 138 . 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. This is sometimes difficult due to the shape or construction of the object being weighed. Combined standard uncertainty of the error U(E) Knowing the error of the scale indication at the point of each calibration is not sufficient. Typical calibration procedures include the eccentricity test. You must also know how certain you can be about the error found at each point of calibration. e. which can be assuredly and accurately measured using the scale in question. A truck scale is unsuitable for weighing letters The purpose of the minimum weight test is to determine the minimum weight. but users. random variation in the indications. There are several sources of uncertainty of the error.calibration of weighing instruments  part 11 repeatedly. In such a case. This enables you to correct the errors and definitions for non-linearity and hysteresis. it may be impractical to use standard weights for calibrating the entire range. with a probability of 99.: Weighing instruments are often highly accurate. often need to know just how inaccurate a particular scale may be. suitable substitution mass is used instead.

g.4 g 1. •  A substitute load is used in calibrating the scale. •  There are random variations in the indications as can be seen in the Repeatability Test.73 % 3. •  Analogous scales have limited readability.2 g. 139 .8 g 0.7 g.27% U(E) = 2u(E) 95. E = 2. •  Air convection causes extra force on the load receptor.5 g ±u(E) 68. which correspond to one standard deviation of a normally distributed variable. with a coverage probability of 68.45 % U(E) = 3u(E) 99. The combined standard uncertainty of the error at a certain point of calibration has a coverage probability of 68. is between is between 1.27% as well. •  Air buoyancy around the weights varies according to barometric pressure.5 g and u(E) = ±0.27%).9 g 4. •  Digital scale indications are rounded to the resolution in use. The values of uncertainty determined at each point of calibration are expressed as standard uncertainties (coverage probability: 68.2 g 3. air temperature and humidity.27%.6 g Example: The calibration error and its uncertainty at the calibration point of 10 kg may be expressed e. •  The weights are not in the exact middle of the load receptor.5 g and the actual error. 1. which means that the calculated error in the indication is 2.1 g 2.8 g and 3.calibration of weighing instruments  part 11 •  The masses of the weights are only known with a certain uncertainty.

140 . barometric pressure and relative humidity of the air may vary. •  Finer resolution is often used in calibration. the uncertainty of the results of later routine weighings is usually larger. you know that if you repeat the calibration several times. then a larger value should be used for the k-factor. or the reliability of the standard uncertainty value is insufficient. its calibration results.1 g and 3.45%. •  The adjustment of the weighing instrument may have changed. Uncertainty of a weighing result The purpose of calibration is to determine how accurate a weighing instrument is. it is extended to a level of 95.0011 kg and 10. •  The temperature.5 g and the actual error.27% is insufficient.45% of the time. then the error and its extended uncertainty at the point of calibration are E = 2. Defining the uncertainty of weighing results is highly recommended.5 g and U(E) = ±1. a coverage probability of 68. •  A load may be situated eccentrically in routine weighing. •  Routine weighing measurements are not repeated whereas indications received through calibrations may be averages of repeated weighing measurements.45% by multiplying it with the coverage factor k = 2. •  Tare balancing device may be used in routine weighing. If you are able to use the k = 2 coverage factor.9 g. Normally. for all The purpose of calibration is to determine how accurate a weighing instrument is. at least once. Standard and expanded uncertainties of weighing results are calculated using technical data of the weighing instrument. If the distribution of the indicated error cannot be considered normal. As the above-mentioned case indicates.calibration of weighing instruments  part 11 Expanded uncertainty in calibration U(E) In practice.4 g. while calibration is made at certain calibration points.0039 kg 95. knowledge of its typical behaviour and knowledge of the conditions of the location where the instrument is used. is between 1. However. the indication of weighing an object of 10 kilograms will be between 10. with a coverage probability of 95. This means that the calculated error of the indication is 2. Typical reasons for this are: •  Routine weighing measurements involve random loads. •  Loading/unloading cycles in calibration and routine weighing may be different.

calibration of weighing instruments  part 11 typical applications and always for critical applications. 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. However. user-defined uncertainty components in addition to supported uncertainty components. Wide variation in user-specific limits is also possible. 141 . determining the uncertainty of weighing results is not part of calibration. copying configurations from one scale to another is easy. Correspondingly. It allows you to enter additional. CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument. Calibrating and testing weighing instruments using CMX CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument. Error limits can be set according to OIML or Handbook-44. 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.

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which makes the temperature calibration process slow and expensive. T/C). the user must be sure to verify the permanency of accuracy. It is important to keep in mind an old saying: all meters. RTD’s are based While standards determine accuracy to which manufacturers must comply. If temperature is a significant measurable variable from the point of view of the process. energy consumption and environmental emission is significant. they nevertheless do not determine the permanency of accuracy. show incorrectly. it is necessary to calibrate the instrument and the temperature sensor. Every temperature measurement is different. Temperature. While standards determine accuracy to which manufacturers must comply. makes it different from other quantities. The polynoms are specified in ITS 90 table (International Temperature Scale of 1990). A temperature measurement consists of several time constants and it is crucial to wait until thermal equilibrium is reached before measuring. Temperature greatly influences many physical features of matter. calibration will prove by how much. and its influence on e. being a state of equilibrium. a model that includes all influencing factors must be created. They either convert temperature into resistance (Resistance Temperature Detectors. RTD) or convert temperature into low voltage (Thermocouples.calibrating temperature instruments Calibrating temperature instruments T he most commonly and most frequently measurable variable in industry is temperature. For each measurement. Metrology contains mathematic formulas for calculating uncertainty.g. Therefore. 143 . Temperature sensors The most commonly used sensors in the industry used for measuring temperature are temperature sensors. they nevertheless do not determine the permanency of accuracy. quality. including sensors.

the transmitter converts the signal from the temperature sensor into a standard ranging between 4 and 20 mA. The uncertainty of calibration is not the same as the accuracy of the device. it also has an impact on the total accuracy. Pt100 is a common RTD type made of platinum and its resistance in 0 ˚C (32 ˚F) is 100∧. and therefore the transmitter must be calibrated on regular basis. temperature transmitters were developed to convert the sensor signal into a format that can be transmitted easier. Most commonly. an external reference temperature sensor is recommended. Nowadays. we compare the sensor to be calibrated and the reference sensor. The heat source may also have an internal temperature measurement that can be used as reference. Therefore. the noble thermo-elements S-. Despite their lower sensitivity (low Seebeck coefficient). while the transmitter converts the sensor signal. The most important criterion in the calibration of temperature sensors is how accurate the sensors are at the same temperature.calibrating temperature instruments on the fact that the resistance changes with temperature. The most common T/C type is the K-type (NiCr/NiAl). a small temperature dependent voltage difference/current can be detected. A temperature transmitter can be calibrated using a temperature calibrator. Calibrating temperature instruments To calibrate a temperature sensor. PtRh/Pt/Rh) are used especially in high temperatures for better accuracy and stability. Thermocouple consists of two different metal wires connected together. R. but the difference in temperature. are also being adopted. and performing calibration is not the least influencing factor. Temperature transmitters The signal from the temperature sensor cannot be transmitted a longer distance than the plant. To make comparisons. The most important criterion in the calibration of temperature sensors is how accurate the sensors are at the same temperature. such as Fieldbus transmitters. but to achieve better accuracy and reliability. transmitters with a digital output signal. This means that the thermocouple is not measuring the temperature. If the connections (hot junction and cold junction) are at different temperatures. Many factors influence the total uncertainty.or B-type (PtRh/Pt. All heat 144 . Sensors are calibrated either by using temperature dry blocks for industrial field or liquid baths (laboratory). it must be inserted into a known temperature.

loading effect. affects both the reference sensor and the unit being tested. heat flux along the length of the thermometer stem. Measurement uncertainty Axial homogeneity Axial homogeneity is the temperature distribution in the measurement zone along the boring (axial temperature distribution). Radial homogeneity Radial homogeneity can be explained as the difference in temperature occurring between the borings. stability and immersion depth. The uncertainty of calibration is not the same as the accuracy of the device. they will affect accuracy. Stem conduction. Immersion depth To achieve a more stable calibration. These effects can be quantified to determine the heat source’s contribution to the measurement uncertainty. 145 . Stability Stability means variation of the temperature in the measurement zone over time when the system has reached equilibrium. Loading effect When several sensors are placed in the borings of the heat source. radial homogeneity. the immersion depth for a probe should be sufficient for the sensor being calibrated.calibrating temperature instruments sources show measurement errors due to their mechanical design and thermodynamic properties.01 (former EA-10/13). 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 major sources of measurement uncertainty are axial homogeneity.

The dry blocks communicate with the Beamex documenting multifunction calibrators enabling fully automated temperature calibration and documentation. CEO of Beamex Group. such as a series of highquality dry blocks for field and laboratory use. 146 . The instrument’s calibration information is saved in the calibrator and History Trend reports. the calibration device must always be more accurate than the instrument or sensor being calibrated. both in numeric and in graphic form.calibrating temperature instruments The calibration of instruments and sensors must be performed periodically. “The temperature products and services we are now introducing form an integral part of the Beamex® Integrated Calibration Solution. more accurate and efficient management of all calibration assets and procedures”. more efficient and accurate solution for calibrating temperature. you can print out a calibration report as well as a traceable. However. which is useful in making decisions about purchasing new instruments. The level of performance a calibration device needs to have depends on the accuracy requirements determined by each company. It is a complete solution for temperature calibration with various products and services. The instrument to be calibrated is connected to the calibrator controlled by a computer. “This helps the client to follow the condition of the instrument. where the computer controls the calibration event. the calibration of instruments effecting production. 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. calibration software and PC for online calibration. determining service in advance and recalibration. With the CMX Software. Calibration of instruments and sensors can be carried out either on site or in a laboratory. says Raimo Ahola. the calibration device must always be more accurate than the instrument or sensor being calibrated. a complete calibration solution that enables faster. However. The calibration results can then be uploaded from the documenting calibrators to the Beamex® CMX Calibration Software. The Beamex® Integrated Calibration Solution concept is the combination of calibrator. smart reference probes and temperature calibration laboratory services. regular calibration of sensors and traceable calibration as well as calibration documentation. Integrated calibration solution – a smarter way to calibrate temperature Beamex has introduced a smarter.

Mr Ahola adds. eliminates any errors related to manual entry and assures repeatable calibration procedures”. The Beamex® Integrated Calibration Solution concept is the combination of calibrator. Our integrated calibration solution concept saves valuable time.calibrating temperature instruments accredited calibration certificate. calibration software and PC for online calibration. 147 .

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If a drop of water gets into hot silicon oil. but they don’t necessarily improve performance. Heat transfer fluids or pastes are sometimes used around or inside the insert. For example. it could even cause a small steam explosion which may splash hot oil on the user. EURAMET The EURAMET guideline (EURAMET /cg-13/v. 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. controller. an internal control sensor and optional readout for external reference sensor. It will also present how to calculate the total uncertainty of a calibration performed with a dry block.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.01. There are fast and lightweight dry blocks for industrial field use as well as models that deliver near bath-level stability in laboratory use. They may actually even impede the dry block’s performance and damage its internal components. This article will focus on models that use interchangeable metallic multi-hole inserts. There are also some work safety issues that favor dry blocks in preference to liquid baths. 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. Dry blocks are almost without exception meant to be used dry. 149 .

The Euramet calibration guide defines a normative way to calibrate dry blocks. whereas the probes to be calibrated are immersed in the insert. 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. Some manufacturers specify these components and some do not. or to use an external reference temperature probe inserted in the block as a reference measurement. 150 .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. As most of the manufacturers nowadays publish their product specifications including the main topics in the Euramet guide. It is possible to use a dry block with the block’s internal measurement as the reference (true value).total uncertainty of temperature calibration dry blocks. There is always thermal resistance between the internal sensor and the probes inside the insert and other sources of uncertainty need to be considered. With dry blocks. the products are easier to compare. 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. •  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 (<= 0.5 mm at –80…660 °C) (<= 1.

for example. • Radial uniformity   Radial uniformity refers to the variation in temperature between the holes of the insert. 151 . •  Axial uniformity  Axial uniformity refers to the variation in temperature along the vertical length of the insert. The purpose of this homogenous measurement zone is to cover various sensor constructions. by the placement of the heaters. 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.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. thermal properties of materials and alignment of the insert holes. The Euramet calibration guide states. Related uncertainty is caused. Non-symmetrical loading or probes with significantly different thermal conductivity (for example large diameter probes) may cause additional temperature variation. a homogenous zone of at least 60 mm is recommended. 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.

then the uncertainty caused by the insufficient immersion should be estimated/ evaluated. Sufficient immersion depth and dual zone control helps to reduce load-related uncertainties. As the probe constructions vary greatly (sheet material. • Immersion Sufficient immersion is important in any temperature measurement. Stability describes how well the temperature remains the same during a given time. when the system has reached equilibrium. a test for each individual probe type to be calibrated should be made. to use immersion depth of 20 x the diameter. • Stability over time –  Stability describes how well the temperature remains the same during a given time.total uncertainty of temperature calibration • Loading effect Every probe in the insert conducts heat either from or into the  insert. it should be estimated or evaluated. If some component has not been specified. The loading effect is not visible in the control sensor indication and the controller cannot completely compensate for this shift. • Hysteresis Hysteresis causes the internal sensor to be dependent on its previous  exposure. wall thickness. –  The Euramet calibration guide defines stability as a temperature variation over a 30-minute period. as a rule of thumb. 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. The more the load.  The Euramet calibration guide states that the immersion depth should be at least 15 x the probe’s outer diameter. the more the ambient temperature will affect the measurements. To minimize the stem conduction error it’s recommended. The specifications for the above uncertainty components should be in the block’s specifications.). The hysteresis is greatest at the mid-point and is proportional to the temperature range. 152 . lead wire thermal conductivity etc. If sufficient recommended immersion cannot be reached. plus the length of the sensing element.

vibration and possible mechanical shocks so it has to be quite a robust mechanically. The internal sensor has to deal with quick temperature changes. the reference probe can be drawn out to match the immersion. Unfortunately. The loading effect is usually much less significant with an external reference sensor. the external reference sensor is inside the insert together with the probes to be calibrated. Using an external reference sensor enables more accurate measurement of the temperature of the probes to be calibrated. the user may obtain good results. It helps to minimize calibration uncertainty but also provides reliability in measurements. 153 . Therefore. the stem conductance has to be taken into account. mechanical robustness is usually inversely proportional to good performance: stability. the user can reduce the axial uniformity well below specification. There are many advantages to using a separate reference sensor. In many cases. Of course. • Loading effect Since the internal sensor cannot completely compensate the load related temperature shift inside the insert. the following uncertainty components should be taken into account: • Axial uniformity A xial uniformity-related uncertainty can be minimized by aligning  the centers of the sensing elements. The internal sensor is used just to adjust temperature close to the desired calibration point and keep it stable. Using an external reference sensor enables smaller total uncertainty of the system. hysteresis. In case the probe to be calibrated is short and won’t reach the measurement zone at the bottom of the insert.total uncertainty of temperature calibration Using an external reference sensor as reference Unlike using the dry block’s internal sensor as a reference. the external reference 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. • Radial uniformity Radial uniformity is still present when using an external reference  probe and should be taken into account as specified. etc. In the case of using an external reference sensor. If the reference sensor and the sensor to be calibrated are sufficiently similar in diameter and thermal conductivity.

drift. • External reference sensor – The external reference sensor (PRT) is typically much more capable of producing accurate measurements than the internal sensor. Dry blocks usually have a stability indicator. It can be the block or an external device. using an external reference does not automatically mean better results. there may still be some difference between the block and the insert temperatures when the indicator shows the unit has stabilized. the external reference sensor needs a unit that measures the sensor. for instance. and it may often be smaller than the specification. – Uncertainty related to the reference probe components includes the probe’s calibration uncertainty. It also helps the user to see when the unit has truly stabilized. but depending on.total uncertainty of temperature calibration • Stability over time The external reference sensor can be used to measure the actual  temperature deviation inside the insert. stem conduction. All of the previously mentioned uncertainty factors need to be carefully considered. The external reference sensor can be used to measure the actual temperature deviation inside the insert and it also helps the user to see when the unit has truly stabilized. However. – Of course. hysteresis. 154 . and the readout device’s uncertainty. the different loads.

Finally the combined uncertainty has been multiplied by two to get the expanded uncertainty.003 0. One is done using the internal temperature measurement and the other with a reference probe.007 0.020 Standard Uncertainty (°C) 0.058 0.007 0.135 MB155R with external measurement @0 °C Component Axial Uniformity Radial Uniformity Stability Loading Effect Ref sensor measurement Specification (°C) 0. The standard uncertainties are combined as the root sum of the squares.02 0.006 0.003 0. they are divided by the square root of three to get the Standard Uncertainty. The various uncertainty components used in the examples can be found in the specifications in the product brochures.014 0. When using an external reference sensor the total expanded uncertainty is 34 mK (0. MB155R with internal measurement @0 °C Component Display Accuracy Hysteresis Axial Uniformity Radial Uniformity Stability Loading Effect Specification (°C) 0.012 0.025 0.003 0. The temperature in both examples is 0 °C.004 0.006 0.005 0.006 Combined Uncertainty: Expanded Uncertainty: Reference Sensor (Beamex RPRT-420) Component Short-term repeatability Drift Hysteresis Calibration uncertainty Specification (°C) 0.028 All specifications have a rectangular probability distribution.010 0.005 0.01 0.034 Standard Uncertainty (°C) 0.017 0.003 0.004 0.02 0.135  °C).01 0. That is why they are divided by the square root of three to get Standard Uncertainty.05 Combined Uncertainty: Expanded Uncertainty: Standard Uncertainty (°C) 0. 155 .006 0. Due to the rectangular probability distribution of the specifications.034 °C).10 0.01 0.067 0.total uncertainty of temperature calibration CALCULATION EXAMPLES ■  Here are two examples of total uncertainty calculations.012 0.01 Combined Uncertainty: Expanded Uncertainty: MB155R and RPRT-420 Combined uncertainty: Expanded Uncertainty: 0.014 0. As can be seen in the examples the total expanded uncertainty using the internal reference sensor is 135 mK (0. In both cases the MB155R is used as the dry block.005 0.006 0.029 0.

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the mA signal was introduced. Several transmitters can be connected to the same pair of wires. Being an open standard. smart transmitter was introduced in the 1980s. instrumentation utilized mainly pneumatic signals to transfer information from transmitters. The Fieldbus transmitters must be calibrated as well. Conventional I/O systems are no longer needed because segment controllers connect the instrument segments to the quicker. During the 1990s. In the 1970s. Each transmitter needs a dedicated pair of cables. one way. But what is fieldbus and how does it differ from conventional instrumentation? Fieldbus transmitters must be calibrated as well. A standard was finally set in the year 2000 when the IEC61158 standard was approved. History of fieldbus Back in the 1940s. higher-level fieldbus backbone. but how can it be done? Conventional transmitters can deliver only one simultaneous parameter. The first fieldbus was introduced in 1988. and I/O subsystems are required to convert the analog mA signal to a digital format for a control system. computerized control systems began to make their arrival. manufacturers battled to see whose fieldbus would be the one most commonly used. but how can it be done? 157 . The first digital.fieldbus transmitters must also be calibrated Fieldbus transmitters must also be calibrated F ieldbus is becoming more and more common in today’s instrumentation. During the 1960s. and throughout the 1990s a number of various fieldbuses were developed. instruments from any manufacturer can be connected to the same fieldbus as plug-and-play. Fieldbus transmitters are able to deliver a huge amount of information via the quick two-way bus. making things much easier. using first proprietary protocols.

Critical applications and hazardous areas have also begun to adopt fieldbus. or even a little bit more. This is caused by many reasons. lower installation labour cost. Another big advantage is the on-line self-diagnostics that helps in predictive maintenance and eventually reduces the downtime. were chosen as standards. One important reason is the better return on investment. The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus market. 158 . less planning/drawing costs. The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus markets. Future of fieldbus Currently. Recent co-operation between Foundation Fieldbus and Profibus suppliers will further strengthen the position of these two standards. such as reduction in field wiring. Both Foundation Fieldbus and Profibus have reached such a large market share that both buses will most likely remain also in the future. 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. offering maintenance savings. The improved system performance is important criteria for some plants. A large portion of new projects is currently being carried out using fieldbus. Fieldbus benefits for industry Obviously process plants would not start utilizing fieldbus. if it would not offer them benefits compared to alternative systems.fieldbus transmitters must also be calibrated Foundation Fieldbus H1 and the Profibus PA. Although fieldbus hardware may cost the same as conventional. Remote configuration also helps to support reduced downtime. There are also certain applications that prefer certain fieldbus installations despite the geographical location. both used in process instrumentation. one can say that the Foundation Fieldbus is dominating the North American markets and the Profibus is the market leader in Europe. There are also other advantages compared to conventional instrumentation. the total installation costs for a fieldbus factory is far less than conventional. For the most part. and no need for conventional I/O subsystems. Other areas are more divided. a large number of fieldbus installations already exist and the number is increasing at a huge rate.

Naturally these two people need to communicate with each other in order to perform and document the calibration. or even a little bit more. such as quality systems and regulations. “calibration” is often used to mean the configuration of a transmitter. Reading the digital output is not always an easy thing to do. In fieldbus terminology. The input is measured with a traceable calibrator. it does not eliminate the need for calibration.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. Changing the output signal does not change the need for periodic calibration. the total installation costs for a fieldbus factory is far less than conventional. The other parts of a fieldbus transmitter are mainly comparable to conventional or HART transmitters. that make the periodic calibrations compulsory. Calibrating fieldbus transmitters The word “calibration” is often misused in the fieldbus terminology when comparing it to the meaning of the word in metrology. you need to find other ways to read the transmitter’s output. When fieldbus is up and running. So it is not possible to calibrate a fieldbus transmitter using only a configurator or configuration software. Although modern fieldbus transmitters have been improved compared to older transmitter models. There are also many other reasons. Although fieldbus hardware may cost the same as conventional. “calibration” means that you compare the transmitter to a traceable measurement standard and document the results. In some cases you can use a portable fieldbus communicator or a laptop computer with dedicated software and hardware. 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. 159 . 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. While your fieldbus and process automation systems are idle. but you also need to have a way to read the output of the fieldbus transmitter. Also. In terminology pertaining to metrology. it is not possible to calibrate a fieldbus transmitter remotely.

time-consuming and may require an abundance of resources.fieldbus transmitters must also be calibrated Fieldbus instruments are increasing in popularity and calibration can in many cases be cumbersome. The Beamex® MC6 can be used as a communicator for the configuration as well as a calibrator for the calibration of smart instruments with the supported protocols. The calibration results can be automatically stored into the memory of the MC6 or uploaded to calibration software. There is no need for an additional communicator. 160 . The Beamex® MC6 will help to overcome these challenges by combining a full field communicator and an extremely accurate multifunctional process calibrator. The Beamex® MC6 can be used as a communicator for the configuration as well as a calibrator for the calibration of smart instruments with the supported protocols.

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etc. 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. In any case. There is no standardized technical definition for what smart really means in practice. A microprocessorbased smart transmitter has a memory that can perform calculations. The vast majority of delivered instruments today are smart instruments. The term “smart” is more of a marketing term than a technical definition. a modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. for the engineers who need to configure and calibrate the transmitter. These new smart instruments bring new challenges to the calibration and configuration processes. 163 . the Beamex® MC6 –Advanced Field Communicator and Calibrator. produce diagnostics. Generally. 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. Engineers can A modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. that will help to overcome these challenges.) and generates an output signal proportional to the measured input. the digital communication protocol is the biggest difference compared to conventional transmitters. in order for a transmitter to be called smart.configuring and calibrating smart instruments Configuring and calibrating smart instruments S o called “smart” instruments are ever more popular in the process industry. What is a “smart” transmitter? A process transmitter is a device that senses a physical parameter (pressure. etc. Furthermore. temperature.

it is compatible with conventional installations. 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. typically also called a communicator. including HART. Recently the HART protocol seems to be getting more boosts from the newest WirelessHART protocol. i. Configuration One important feature of a smart transmitter is that it can be configured via the digital protocol.e. Most of the protocols are based on open standards. no analog signal. but they need to have the possibility to communicate with the transmitter and read the digital signal. sensor type. Since it also has the analog signal. A HART transmitter contains both a conventional analog mA signal and a digital signal superimposed on top of the analog signal. would be a transmitter with a purely analog (or even pneumatic) output signal. It is crucial to remember that although a communicator can be used for configuration. contain only a digital output. you will need to use some form of configuration device.configuring and calibrating smart instruments no longer simply measure the output analog signal. So in order to do the configuration. to support the selected protocol. a non-smart transmitter. Some are proprietary protocols of a certain manufacturer. This article will discuss “smart” transmitters. WirelessHART. The most common transmitter protocol today is the HART (Highway Addressable Remote Transducer) protocol. The fieldbuses. such as Foundation Fieldbus and Profibus. it is not a reference standard and therefore cannot be used for metrological calibration. Foundation Fieldbus and Profibus PA protocols. Smart transmitter protocols There are various digital protocols that exist among transmitters considered smart. etc. These parameters may include engineering unit.how can the digital output be read? Thinking of the opposite of a smart transmitter. Foundation Fieldbus and Profibus are gaining a larger foothold on the process transmitter markets. That brings a whole new challenge . The configuration needs to be done via the communication protocol. Configuration of a smart transmitter refers to the setting of the transmitter parameters. 164 .

For a real metrological calibration. 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. you need a dual-function calibrator able to process transmitter input and output at the same time. especially a mobile one. i. The calibration may. by using a calibrator.e. but in order to see what the transmitter output is. by definition a traceable reference standard (calibrator) is always needed. you will need some device or software able to read and interpret the digital protocol. or alternatively two separate singlefunction calibrators. The transmitter input needs to be generated/ measured the same way as with a conventional transmitter. Wired HART (as opposed to WirelessHART) is a hybrid protocol that includes digital communication superimposed on a conventional analog 4–20mA output signal. to do any configuration or trimming. by using a calibrator. If the calibration is done with a documenting calibrator. be a very challenging task.configuring and calibrating smart instruments It is crucial to remember that although a communicator can be used for configuration. a device or software able to read and interpret the digital protocol is needed. potential adjustments are often included when the calibration process is performed. 165 . therefore. However. with output being a digital protocol signal.e. Sometimes it is very difficult or even impossible to find a suitable device. Although the calibration formally does not include any adjustments. In this case calibration is quite easy and straight forward. it will automatically document the calibration results. i. To calibrate a conventional. a HART communicator is needed. However. several types of devices may be needed and several people to do the job. calibration is a comparison of the device under test against a traceable reference instrument (calibrator) and documenting the comparison. But how can a smart transmitter. be calibrated? Obviously the transmitter input still needs to be generated/measured the same way as with a conventional transmitter. which can read the digital output. it is not a reference standard and therefore cannot be used for metrological calibration. The 4–20mA output signal of a wired HART transmitter is calibrated the same way as a conventional transmitter. to see what the transmitter output is. you can generate or measure the transmitter input and at the same time measure the transmitter output. analog transmitter. or to read the digital output signal (if it is used). Calibration of a smart transmitter According to international standards.

There are some other “smart” process calibrators on the market with limited support for different protocols. calibrator. ergonomic design and light weight make it an ideal measurement device for field use in various industries. a separate communicator is needed in any case. In practice.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. About Beamex® MC6 Beamex® MC6 is an advanced. WirelessHART. 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. typically only for one protocol (mostly HART) and offering very limited support. The MC6 also contains a full fieldbus communicator for HART. The MC6 supports all of the protocol commands according to the transmitter’s device description file. When it comes to configuration of the smart transmitters. It has a large 5. The MC6 is one device with five different operational modes. Foundation Fieldbus and Profibus PA instruments.7" color touch-screen with a multilingual user interface. such as the pharmaceutical. the smart transmitter’s input can be generated/ measured at the same time as reading the digital output. which means that it is fast and easy to use. The usability and ease-of-use are among the main features of the MC6. the MC6 includes a full field communicator for HART. oil and gas. temperature and various electrical signals. Any additional communicator is therefore not needed. The results can be automatically stored into the memory of the MC6 or uploaded to calibration software. energy. All required electronics are built-in. the smart transmitter’s input can be generated/ measured at the same time as reading the digital output. The operation modes are: meter. service as well as the petrochemical and chemical industries. Foundation Fieldbus H1 and Profibus PA protocols. It offers calibration capabilities for pressure. high-accuracy field calibrator and communicator. With the Beamex® MC6. 166 . food and beverage. including power supply and required impedances for the protocols. The robust IP65-rated dustand water-proof casing. With the Beamex® MC6. and you can carry less equipment in the field.

•  Environmental reasons. So why would you calibrate them? First of all. enabling fully automated and paperless calibration and documentation. •  Economical reasons – any measurement having direct economical effect. 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”. etc. The MC6 also contains a full fieldbus communicator for HART. the MC6 is more than a calibrator. 167 . There are numerous reasons to calibrate instruments initially and periodically. standards. the MC6 communicates with Beamex® CMX Calibration Software. •  Even the best instruments and sensors drift over time.employee safety as well as customer/patient safety.configuring and calibrating smart instruments documenting calibrator. •  Regulatory requirements. In addition. In conclusion. such as quality systems. environmental systems. •  Safety reasons. the output protocol of a transmitter does not change the fundamental need for calibration. safety systems. A short summary of the main reasons include. •  To achieve high and consistent product quality and to optimize processes. Foundation Fieldbus and Profibus PA instruments. especially when used in demanding process conditions. data logger and Fieldbus communicator.

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universities. power generation. in many locations. This means that certain areas of a water treatment plant may well be considered hazardous. may pose hazards as well. many materials and fluids used in seemingly “safe” industries are themselves flammable. water/ wastewater. food.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. are used in all industries. abnormal conditions. 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. If this were truly the case. However. and chemical plants are flammable and are typically contained within vessels and pipes. oil refineries. Improperly calibrating an instrument in this hazardous environment can be almost as dangerous. Therefore. such as reactors that hydrogenate oils. Even seemingly safe water treatment systems use combustible materials such as chlorine in their processes. leaks. For example. including agriculture. Hydrocarbons and other flammable fluids are not limited to the petroleum and chemical industries. 169 . an external flame would not ignite the hydrocarbons. retail. For example. hydrocarbons in mines. and fluid accumulation may allow hydrocarbons to be present such that the flame could ignite the hydrocarbons with disastrous results. combustible fuels. In addition. Similarly. such as natural gas. and in the home. certain areas of food plants. pharmaceuticals. The materials and fluids used in some processes can be hazardous in the sense that they can ignite or explode. pulp/paper.

and maintained in accordance with practices that are appropriate for the hazard. ib Flammable material present intermittently Zone 2 ia. Adding the applicability of IS designs to various hazards in the previous table yields: Zone 0 ia Flammable material present continuously Zone 1 ia. Equipment requirements in hazardous locations Protection requirements for hazardous locations vary according to the type of material present. and the protection concept applied. Groupings (IEC 60079-10) in order of decreasing ignition energy (with an example of a gas in the group) are: Intrinsic Safety (IS) is the most common protection concept applied to calibrators used in hazardous locations.calibration in hazardous environments selected. installed. Temperature classes limit the maximum surface temperature between 450˚C (T1) and 85˚C (T6). The intensity with which various vapors can combust is generally different. In general. 170 . frequency of the hazard. a hot surface temperature on a device can cause ignition. ib Flammable material present abnormally In addition. 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. 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.

This software generally makes calibration work faster and easier and is designed to integrate into management systems such as SAP and Maximo. level. and other variables designed in hazardous locations are generally used to monitor and control the process. pulse. 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. there are calibrators that are specifically designed to operate safely in rugged environments and hazardous locations. The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work. The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work. This is usually not the case. RTD. The ergonomic design and modular construction allow the user to select the necessary functions in a cost-effective manner. As such. temperature. In some applications. which means that many instruments are calibrated in the field. Fortunately. they can be used for the overwhelming majority of applications where a vapor hazard is present. current. and frequency measurements.calibration in hazardous environments Beamex calibrators for hazardous locations are designed and certified for Ex ia IIC T4 hazards per the ATEX Directive and are applicable to all vapor hazards where a temperature class of 135˚C in a 50˚C ambient is acceptable. and tracks calibration history. creates documentation. pressure. voltage. but also automatically takes data. adheres to GMP regulations (21 CFR 11). thermocouple. it is practical to remove these instruments and calibrate them on the workshop with a calibration test bench. Calibration solutions for hazardous locations Instruments designed to measure flow. It not only alerts you when to calibrate. 171 . The Beamex multifunction IS-calibrators are portable and intrinsically safe and have modules that can accommodate wide ranges and many types of pressure.

Hazardous locations can exist in virtually all industries. •  Hazardous locations can exist in virtually all industries. and maintained in accordance with requirements for the hazardous location. 172 .calibration in hazardous environments A few points to remember •  Improper actions in hazardous locations can result in property damage and bodily injury. •  Instruments should be specified. and in the home. and in the home. installed. stores. stores. operated. •  Portable Beamex calibrators for hazardous locations are designed to be used in virtually all vapor hazards.

calibration in hazardous environments 173 .

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intrinsically safe fieldbus calibrators enter into the picture. intrinsic safety (IS) is a protection technique for safely operating electronic equipment in explosive environments. mists. An intrinsically safe calibrator is therefore designed to be incapable of causing ignition in the surrounding environment with flammable materials.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. such as oil refineries. rigs and processing plants. Intrinsically safe calibrators are also often referred to being “Ex calibrators”. By definition. and if it occurs it will exist only for a short time. Zone 1: an explosive gas & air mixture is likely to occur in normal operation. or “IS calibrators”. Where is intrinsically safe calibration required? Many industries require intrinsically safe calibration equipment. a flammable substance and oxygen. When safety becomes a top priority issue in calibration. Intrinsically safe calibrators are designed for potentially explosive environments. such as gases. The idea behind intrinsic safety is to make sure that the available electrical and thermal energy in a system is always low enough that ignition of the hazardous atmosphere cannot occur. Zone 2: an explosive gas & air mixture is not likely to occur in normal operation. An Ex Area also refers to an explosive environment and an Ex calibrator is a device designed for use in the type of environment in question. vapors or combustible dust. There are also industrial environments where the calibration of fieldbus instruments should not only be made accurately and efficiently. “calibrators for Ex Areas”. A hazardous atmosphere is an area that contains elements that may cause an explosion: source of ignition. 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. but also safely. The concept has been developed for safely operating process control instrumentation in hazardous areas. 175 .

Basically. but in a safe way. Basically. 176 . In addition. They can be used for calibration of pressure. This eliminates the need of manual recording of calibration data and improves the quality and productivity of the entire calibration process. such as the Beamex® MC5. Secondly. 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. Safest possible technique Intrinsically safe calibrators are safe for employees. 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). temperature and electrical signals. In view of safety. the calibrators provide performance and functionality. which should be read carefully before using the device. petrochemical and chemical plants. it is the safest possible technique. The product safety note lists all the “do’s and don’ts” for safe calibration. provides additional efficiency improvements with its seamless communication with calibration software. What are the benefits of using intrinsically safe calibrators? There are clear benefits in using intrinsically safe calibration equipment. 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. First of all.IS. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. there are also some guidelines and constraints for how to use them in hazardous areas. A documenting intrinsically safe calibrator. Performance and functionality Multifunctional intrinsically safe calibrators provide the functionality and performance of regular industrial calibration devices.the safest way to calibrate fieldbus instruments pipelines and distribution centres. as well as pharmaceutical plants. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators.

. IEC (International Electrotechnical Commission) is a nonprofit international standards organization that prepares and publishes international standards for electrical technologies. In addition. 2003. maximum is lower). maximum is lower) • Battery slower to charge. Making a calibrator safe and unable to cause ignition – typical technical differences: • Surface made of conductive material • Constraints in using the device (listed in Product Safety Note) • Small differences with electrical ranges (e. but they must also be intrinsically safe. Many times intrinsically safe equipment operate only with dry batteries. The IEC TC/31 technical committee deals with the standards related to equipment for explosive atmospheres. 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.g. There are also usually small differences with electrical ranges compared to regular industrial calibrators (e. When charging the battery. quicker to discharge • Battery must be charged in a non-Ex area • When using external pressure modules.g. The surface of the device is made of conductive material. explosive atmospheres in French) is a standard set in the European Union for explosion protection in the industry. The objective of the IECEx Scheme is to facilitate international trade in equipment and services for use in explosive atmospheres.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. it must be done in a non-Ex area. External pressure modules can be used with IS-calibrators. 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. while maintaining the required level of safety. IECEx is an international scheme for certifying procedures for equipment designed for use in explosive atmospheres. 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. but the Beamex intrinsically safe calibrators operate with chargeable batteries. they must be IS-versions What are ATEX and IECEx? ATEX (“ATmosphères EXplosibles”. The battery of an intrinsically safe calibrator is usually slower to charge and it discharges quicker.

Recalibration can be done by calibration laboratories (still preferably with ISO/IEC 17025 accreditation). which means that it communicates seamlessly with calibration software. Being an all-in-one calibrator. The MC5-IS is also ATEX and IECEx certified. The MC5-IS can also be used for calibrating Foundation Fieldbus H1 or Profibus PA transmitters. 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. electrical and frequency signals. temperature. it ensures the calibrator is fit for its intended purpose and that sufficient information is supplied with it to ensure that it can be used safely.the safest way to calibrate fieldbus instruments As Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is certified according to ATEX and the IECEx Scheme. It is a documenting calibrator. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. 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 MC5-IS also has HART communication. 178 . the MC5-IS replaces many individual measurement devices and calibrators. The MC5-IS also has HART communication. all-in-one calibrator for extreme environments. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. The best way to do this is to send it to the manufacturer or to an authorized service company for repair. The MC5-IS has calibration capabilities for pressure.

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It is a supplement to the VIM. so everyone in the business knows what it is. its definition from a common grammar dictionary should never be used in work where the technical standard can apply. journals. If a word is defined in a technical standard. only the technical definitions should be used. The Metrology Handbook. However. scientific and engineering work (such as metrology) it is important to correctly use words that have a technical meaning. GUM. and the information in the other references listed at the end. the purpose of common dictionaries is to record the ways that people actually use words. as well as publications of relevant technical and professional organizations.appendix: calibration terminology a to z 1 Calibration terminology A to Z 1 T his glossary is a quick reference to the meaning of common terms. The technical definitions may be different from the definitions published in common grammar dictionaries. Many of these definitions are adapted from the references. ______________ 1. Those documents give the intended meaning of the word. In technical. international and industry standards. Definitions of these words are in relevant national. 181 . In some cases several may be merged to better clarify the meaning or adapt the wording to common metrology usage. Jay L. Milwaukee: ASQ Quality Press. NCSL Glossary. In technical work. not to standardize the way the words should be used.  Bucher. 2004. and other publications.

appendix: calibration terminology a to z 1 Terms that are not in this glossary may be found in one of these primary references: 1. ISO. Accreditation criteria – Set of requirements used by an accrediting body that a laboratory must meet in order to be accredited. Boulder. 3. IFCC. Accreditation body – An organization that conducts laboratory accreditation evaluations in conformance to ISO Guide 58. 1999. 2nd ed. CO: NCSL International.  ANSI/NCSL. accuracy of a measurement is always 182 . (VIM. ANSI/NCSL Z540-2-1997. An accreditation certificate without the documented parameters is incomplete. (It is assumed that a calibration or metrology activity owns copies of these as part of its basic reference material. CO: NCSL International. IEC.  ISO. U. BIPM. not a replacement of them. 1997. 1993.  NCSL. serves as proof of accredited status for the time period listed.) 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. Accreditation certificate – Document issued by an accreditation body to a laboratory that has met the conditions and criteria for accreditation. S. Accreditation includes evaluation of both the quality management system and the competence to perform the measurements listed in the scope. IUPAC.5) Because the true value is always unknown. Guide to the expression of uncertainty in measurement (called the GUM). The certificate. NCSL Glossary of metrology-related terms. with the documented measurement parameters and their best uncertainties. 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. International vocabulary of basic and general terms in metrology (called the VIM). IUPAP. Geneva: ISO. 2. 3. Some terms may be listed in this glossary in order to expand on the definition. but should be considered an addition to the references listed above. Boulder. and OIML.

25) The value and direction of the bias is determined by calibration and/or gage R&R studies. Adding a correction. It is the process of verifying the capability and performance of an item of measuring and test equipment by comparison to traceable measurement standards. (VIM. which is always the negative of the bias. compensates for the bias. An accuracy statement by itself has no meaning other than as an indicator of quality. It has quantitative value only when accompanied by information about the uncertainty of the measuring system. (See VIM 6. 5. 5. or when performing more-or-less routine calibrations of nearly ideal measuring instruments designed for the measurement of that quantity.18) Accuracy is a design specification and may be verified during calibration.11 and NCSL pages 4–5 for primary and secondary definitions. Calibration is performed with the item being calibrated in 183 .) Calibration is a term that has many different – but similar – definitions. Bias – Bias is the known systematic error of a measuring instrument. systematic error Calibration – (1). conserve. realize. 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. Bespoke/Customized computerised system – A computerised system individually designed to suit a specific business process Best measurement capability – For an accredited laboratory. (VIM. or reproduce a unit of that quantity or one or more of its values. See also: correction.appendix: calibration terminology a to z 1 an estimate.” (EA-4/02) The best measurement capability is based on evaluations of actual measurements using generally accepted methods of evaluating measurement uncertainty. Contrast with: accuracy (of a measurement) Application – Software installed on a defined platform/hardware providing specific functionality Assessment – Examination typically performed on-site of a testing or calibration laboratory to evaluate its conformance to conditions and criteria for accreditation. the best measurement capability for a particular quantity is “the smallest uncertainty of measurement a laboratory can achieve within its scope of accreditation when performing more or less routine calibrations of nearly ideal measurement standards intended to define.

or is otherwise in an indeterminate state. to a measurement system or device of specified capability and known uncertainty in order to detect. calibration procedure Contrast with: calibration (2) and repair Calibration – 2 A) Many manufacturers incorrectly use the term calibration to name the process of alignment or adjustment of an item that is either newly manufactured or is known to be out of tolerance. The calibration process consists of comparing an IM&TE unit with specified tolerances. or the determination of one or more corrections.appendix: calibration terminology a to z 1 its normal operating configuration – as the normal operator would use it. Notes: •  A requirement for calibration does not imply that the item being calibrated can or should be adjusted. Calibration is performed according to a specified documented calibration procedure. or minor adjustment such as zero and span. may be included as part of the calibration. report. under a set of specified and controlled measurement conditions. The result of a calibration is a determination of the performance quality of the instrument with respect to the desired specifications. 184 . determining or assigning one or more values. measurement standards. •  The calibration process may include. but of unverified accuracy. fuses. This may be in the form of a pass/fail decision. calculation of correction factors or adjustment of the instrument being compared to reduce the magnitude of the inaccuracy. See also: performance test. The calibration process uses traceable external stimuli. •  In some cases. and with a specified and controlled measurement system. Calibration provides assurance that the instrument is capable of making measurements to its performance specification when it is correctly used. if necessary. 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. minor repair such as replacement of batteries. or lamps. or artifacts as needed to verify the performance. or minimize by adjustment any deviations from the tolerance limits or any other variation in the accuracy of the instrument being compared. •  Calibration does not include any maintenance or repair actions except as just noted.

specifications. These and similar tasks are excluded from the metrological definition of calibration. and the effective date. A calibration procedure documents one method of verifying the actual performance of the item being calibrated against its performance specifications. A calibration certificate should provide other information to allow the user to judge the adequacy and quality of the calibration. (2) In a laboratory database program. the intent is that they are part of the normal work done by a trained user of the system.appendix: calibration terminology a to z 1 is known to be out of tolerance. Contrast with: calibration (1) See also: normalization. the organization presenting the certificate. a means to record 185 . a metrology laboratory or department. It may be called a calibration laboratory. if it is amended later a new certificate is created. A laboratory database certificate is a record that cannot be changed. (B) In many cases. self-calibration. a certificate often refers to the permanent record of the final result of a calibration. shop. including subsidiary operations of a larger entity. calibration means the same as alignment or adjustment. It provides a list of recommended calibration standards to use for the calibration. or an industry-specific name. 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. IM&TE instruction manuals may use calibration to describe tasks normally performed by the operator of a measurement system. which are repair activities and excluded from the metrological definition of calibration. It may be external or internal. 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. or department. When calibration is used to refer to tasks like this. Calibration certificate – (1) A calibration certificate is generally a document that states that a specific item was calibrated by an organization. or any combination or variation of these. or tolerances for a model of measuring or testing equipment. The certificate identifies the item calibrated. or after it is repaired. Examples include performing a selftest as part of normal operation or performing a self-calibration (normalizing) a measurement system before use.

6. a calibration report includes details of the methods and standards used. and the actual measurement results and uncertainty. As calibration standards are used to calibrate other IM&TE items. and NCSL pages 36–38. Calibration standards generally have lower uncertainty and better resolution than general-purpose items. they are more closely controlled and characterized than the workload items they are used for. and by virtue of its design and material. A calibration program may also be called a measurement management system (ISO 10012:2003).1 through 6.14. when removed or tampered with.13. 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. clearly indicates tampering. See also: calibration certificate Calibration seal – A calibration seal is a device. and information sufficient to determine if the unit being calibrated is operating within the necessary performance specifications. Calibration program – A calibration program is a process of the quality management system that includes management of the use and control of calibrated inspection. 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. Calibration standard – (See VIM. In addition to the basic items of a calibration certificate.appendix: calibration terminology a to z 1 quantitative performance data both before and after adjustments. Calibration report – A calibration report is a document that provides details of the calibration of an item. standard reference material. or measurement transfer standard that is designated as being used only to perform calibrations of other IM&TE items. Note: A calibration seal may also be referred to as a tamper seal. artifact. The purpose of a calibration seal is to ensure the integrity of the calibration.) A calibration standard is an IM&TE item. Designation as a 186 .9. the parameters checked. 6. Note: A calibration procedure does not include any maintenance or repair actions. and the process of calibrating IM&TE used to determine conformance to requirements or used in supporting activities. and test and measuring equipment (IM&TE).” 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. placard. or label that. and 6.

lines. Confidence intervals can be calculated for points. one might be designated as a calibration standard while the others are all general purpose IM&TE items. The terms are the variances or covariances of these other quantities. 187 . standard deviations. Calibration standards are often called measurement standards. not on any other consideration. and t  is the Student’s T value for α ⁄2 and (n – 1) (α is the level of significance). (GUM. 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. s is the sample standard deviation. the demonstrated ability to apply knowledge and skills. weighted according to how the measurement result varies with changes in those quantities. x is the sample mean. in a group of identical instruments.3. n is the number of items in the sample. whose fitness for use is demonstrated by a broad spectrum of users. and so on. Note: The word qualification is sometimes used in the personal sense. The confidence interval is calculated from sample statistics. when that result is obtained from the values of a number of other quantities. slopes. It is equal to the positive square root of a sum of terms. however. the confidence interval is: p (1 – p) s CI = x ¯ ± t = –––   or   CI = p ±  ––––––––– n    n where CI is the confidence interval. For example. Competence – For a laboratory.4) See also: expanded uncertainty Commercial of the shelf software – Software commercially available. See also: standard (measurement) Combined standard uncertainty – The standard uncertainty of the result of a measurement.appendix: calibration terminology a to z 1 calibration standard is based on the use of the specific instrument. 2. For an infinite (or very large compared to the sample) population. the demonstrated ability to perform the tests or calibrations within the accreditation scope and to meet other criteria established by the accreditation body. p is the proportion of items of a given type in the population. since it is a synonym and has more accepted usage in the United States.

(VIM. error (or measurement error) is an estimate of the difference between the measured value and the probable true value of the object of the measurement. Compare with: preventive action Coverage factor – A numerical factor used as a multiplier of the combined standard uncertainty in order to obtain an expanded uncertainty. Deficiency – Nonfulfillment of conditions and/or criteria for accreditation. and/or accredited organizations in other countries as being essentially equal to the NMI. 3. Systematic error (also known as bias) may be corrected.10. systematic error Corrective action – Corrective action is something done to correct a nonconformance when it arises. which 188 . random error.3. error. documented determination that a specific instrument or type of instrument is suitable for use in place of the one originally listed. Error (of measurement) – (See VIM. and/or accredited organizations within the host country. (GUM.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. random error. systematic error Gage R&R – Gage repeatability and reproducibility study. It is usually given the value 2. which approximately corresponds to a probability of 95 percent for degrees of freedom > 10’. accreditation body.15) Any residual amount is treated as random error. correction (of error). for a particular application. accreditation bodies. 2. Equivalence – (A) Acceptance of the competence of other national metrology institutes (NMI). sometimes referred to as a nonconformance. 3. 3. and NCSL pages 11–13.) In metrology. 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. The error can never be known exactly. See also: bias. including actions taken to prevent reoccurrence of the nonconformance. Error may be systematic and/or random.6) The coverage factor is identified by the symbol k. it is always an estimate. The correction value is equal to the negative of the bias. (B) A formal. See also: bias. The exact meaning can usually be determined from examination of the calibration certificate.12–3. Departure value – A term used by a few calibration laboratories to refer to bias.14. error or systematic error.

personnel. or SPETE (special purpose electronic test equipment). so it is a first-party audit. TMDE (test. pressure. 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. International Organization for Standardization (ISO) – An international nongovernmental organization chartered by the United Nations in 1947. and evaluation of tests or calibrations on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions. An internal audit is done by or on behalf of the laboratory itself. performance. measuring. IM&TE – The acronym IM&TE refers to inspection. Some organizations do not include instruments used solely to check for the presence or absence of a condition (such as voltage. and test equipment.appendix: calibration terminology a to z 1 (typically) employs numerous instruments. In the United States. The number of instruments. GUM – An acronym commonly used to identify the ISO Guide to the Expression of Uncertainty in Measurement. IM&TE items are typically used in applications where the measurement results are used to determine conformance to technical or quality requirements before. PMET (precision measuring equipment and tooling). the equivalent document is ANSI/NCSL Z540-2-1997. and length of time are established to be statistically valid consistent with the size and level of activity of the organization. S. and measurements over a period of time to capture quantitative observations. This term includes all items that fall under a calibration or measurement management program. The data captured are analyzed statistically to obtain best measurement capability. or after a process. PME (precision measuring equipment). measurements. Switzerland. personnel. Interlaboratory comparison – Organization. and so on) where a tolerance is not specified and the indication is not critical to safety. Guide to the Expression of Uncertainty in Measurement. The mission of ISO is “to promote the development of standardization and 189 . with headquarters in Geneva. Note: Organizations may refer to IM&TE items as MTE (measuring and testing equipment). GPETE (general purpose electronic test equipment). U. which is expressed as an uncertainty with a coverage factor of k = 2 to approximate 95 percent. during. and diagnostic equipment). measuring.

The members of ISO are the designated national standards bodies of each country. (VIM. specification. 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. 2.) SI units are defined and maintained by the International Bureau of Weights and Measures (BIPM) in Paris. (Mass. which makes it possible for the application to function. it would be different in each language.” The scope of ISO’s work covers all fields of business. and luminous intensity. (The acronym SI is from the French Systéme International. testing.) SI is international system of measurement for all physical quantities. The International Organization for Standardization chose the word as the short form of the name. ISO is not an acronym. time. scientific. technological and economic activity.appendix: calibration terminology a to z 1 related activities in the world with a view to facilitating the international exchange of goods and services. installation. operation. and to developing cooperation in the spheres of intellectual. ISO – Iso is a Greek word root meaning equal. Management review – The planned. periodic. length.) The name also symbolizes the mission of the organization – to equalize standards worldwide. (If the acronym was based on the full name were used. (The United States is represented by ANSI. amount of substance. In this context. 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. The SI system is popularly known as the metric system. the coverage level expressed as a percent. industry and commerce except electrical and electronic engineering. France.) See also: ISO International System of Units (SI) – A defined and coherent system of units adopted and used by international treaties. Life cycle – All phases in the life of the system from initial requirements until retirement including design. Effectively. and maintenance. electric current. programming. and p is the coverage probability or level of confidence of the interval. Measurement – A set of operations performed for the purpose of determining the value of a quantity. so it will be a constant in all languages.1) 190 . IT Infrastructure – The hardware and software such as networking software and operation systems. formal. thermodynamic temperature.

Mobile operations – Operations that are independent of an established calibration laboratory facility. For example. and the base of natural logarithms (e). Metrolog y – Metrology is the science and practice of measurement (VIM. Natural (physical) constant – A natural constant is a fundamental value that is accepted by the scientific community as valid. NCSL is a nonprofit organization. the personnel. Any value other than zero is an offset created by inhomogeneity of the thermocouple wires combined 191 .16 K). associated materials and accessories. NCSL promotes technical and managerial excellence in the field of metrology. and the physical environment. or commerce. NCSL international – Formerly known as the National Conference of Standards Laboratories (NCSL). NCSL was formed in 1961 to “promote cooperative efforts for solving the common problems faced by measurement laboratories. and other quantifiable factors that combine to determine the success of a measurement process. the quantum charge ratio (h/e). Mobile operations may include work from an office space. scientific. then the theoretical thermoelectric emf measured at the copper wires should be zero. 2.” Normalization. vehicle. Natural constants are used in the basic theoretical descriptions of the universe.2). The measurement system includes at least the test and measuring instruments and devices. if the thermocouple alloy leads of a reference junction probe are formed into a measurement junction and placed in an ice point cell. development. the gravitational constant (G). the procedures used. conditions. home. methods. people. commercial and government facilities around the world. and the reference junction itself is also in the ice point. measurement standards. industrial. the triple point of water (273. instrument calibration.appendix: calibration terminology a to z 1 Measurement system – A measurement system is the set of equipment. whose membership is open to any organization with an interest in the science of measurement and its application in research. or the use of a virtual office. the ratio of a circle’s circumference to its diameter (p). and test and measurement. Examples of natural physical constants important in metrology are the speed of light in a vacuum (c). 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. education. NCSL has member organizations from academic.

Calibration: see calibration procedure. Performance Test – A performance test (or performance verification) is the activity of verifying the performance of an item of measuring and test equipment to provide assurance that the instrument is capable of making correct measurements when it is properly used. page 26) Precision is not the same as accuracy. Preventive action helps improve the system. Policy statements relevant to the quality management system are generally stated in the quality manual. (NCSL. (VIM. A procedure has more detail than a policy but less detail than a work instruction. 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. See also: policy Process owner – The person responsible for the business process. Contrast with: corrective action Procedure – A procedure describes a specific process for implementing all or a portion of a policy. vision. This includes climate-controlled mobile laboratories. 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. 192 . Some policies may be implemented by fairly detailed procedures. goals. while others may only have a few general guidelines. A policy describes what management intends to have done regarding a given portion of business activity. Compare with: bias.appendix: calibration terminology a to z 1 with other uncertainties. 3. Policies can also be in the organization’s policy/procedure manual. or general management position on a specific topic. There may be more than one procedure for a given policy. 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. A performance test is done with the item in its normal operating configuration. See also: procedure Precision – Precision is a property of a measuring system or instrument. but actually perform the calibration actions at customer locations. A performance test is the same as a calibration (1).5) Preventive action – Preventive action is something done to prevent the possible future occurrence of a nonconformance.

auditors use the quality manual when they audit the quality management system. Passing the calibration test indicates success of the repair. the GUM specifically does not replace random error with either Type A or Type B methods of evaluation. In addition to its regular use by the organization. See also: error Compare with: systematic error Repair – Repair is the process of returning an unserviceable or nonconforming item to serviceable condition. The instrument is opened. 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. or is removed from its case and may be disassembled to some degree. repair is always followed by calibration of the item. Contrast with: calibration (1). fuses. Repair includes adjustment or alignment of the item as well as component-level repair. Examples include replacement of batteries. or replacing one or two in-stock components. Therefore.appendix: calibration terminology a to z 1 Proficiency testing – Determination of laboratory testing performance by means of interlaboratory comparisons. Random error is usually evaluated by Type A methods. or minor cleaning of switch contacts. is a measure of dispersion. or lamps. but Type B methods are also used in some situations. 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. or has covers removed. 3. Passing 193 . For calibratable items. (Some minor adjustment such as zero and span may be included as part of the calibration. it does not usually contain any detailed policies and never contains any procedures. minor repair is always followed by calibration of the item. work instructions. Note: Contrary to popular belief. Random error – Random error is the result of a single measurement of a value. (VIM.) The need for repair may be indicated by the results of a calibration. The quality manual is generally provided to customers on request. or proprietary information. or repairing a broken wire. Quality manual – The quality manual is the document that describes the quality management policy of an organization with respect to a specified conformance standard. therefore.13) Random error causes scatter in the results of a sequence of readings and. minus the mean of a large number of measurements of the same value. For calibratable items.

repair Reported value – One or more numerical results of a calibration process. The accreditation body usually defines the format and other details. and where substantial disassembly of the instrument is not required. day. The specific type and format vary according to the type of measurement being made. Contrast with: calibration (1). Round robin – See: Interlaboratory Comparison Scope of accreditation – For an accredited calibration or testing laboratory. The value may be reported this way when it is known that the instrument is part of a measuring system and the systematic error will be used to calculate a correction that will apply to the measurement system results. The uncertainty is usually expanded uncertainty as defined in the GUM. Self-calibration – Self-calibration is a process performed by a user for the purpose of making an IM&TE instrument or system ready for use. or once per shift. parameters. •  Deviation from the nominal (or reference) value and uncertainty. and where no parts have to be ordered from external suppliers. specific measurements. The process may be required at intervals such as every power-on sequence. The uncertainty of the deviation is usually expanded uncertainty as defined in the GUM. The reported value is the difference between the nominal value and the mean of a number of repeat measurements. with the associated measurement uncertainty. uncertainty. and only the listed areas may be offered as accredited calibrations or tests. The reported value is usually the mean of a number of repeat measurements. •  Estimated systematic error and uncertainty. or week of continuous operation. The scope document is an attachment to the certificate of accreditation and the certificate is incomplete without it. Only the calibration or testing areas that the laboratory is accredited for are listed in the scope document.appendix: calibration terminology a to z 1 the calibration test indicates success of the repair. or if the ambient temperature changes by a specified 194 . as recorded on a calibration report or certificate. In general. the scope is a documented list of calibration or testing fields. or calibrations and their best measurement. Minor repairs are defined as repairs that take no longer than a short time as defined by laboratory management. most reported values will be in one of these formats: •  Measurement result and uncertainty.

Customers use specifications to determine the suitability of a product for their own applications. The usual purpose is accuracy enhancement by characterization of errors inherent in the measurement system before the item to be measured is connected. calibration standard. if an instrument requires self-calibration before use. an étalon) is a system. An example is ANSI/NCSL Z540-11994. reference standard. laboratory standard. Standard (document) – A standard (industry. instrument. Measurement standards are generally used in calibration laboratories. repair. Standard (measurement) – A standard (measurement 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.B) Contrast with: calibration (1) Specification – In metrology. A product that performs outside the specification limits when tested (calibrated) is rejected for later adjustment. Accepted as having the highest metrological 195 . The value and uncertainty of the standard define a limit to the measurements that can be made: a laboratory can never have better precision or accuracy than its standards. device. or the methods for evaluation of any of these. Once initiated. or material that is used as a defined basis for making quantitative measurements. national. or international standard. government. a specification is a documented statement of the expected performance capabilities of a large group of substantially identical measuring instruments. Compare with: calibration (2. or scrapping. Also. given in terms of the relevant parameters and including the accuracy or uncertainty. then that will also be accomplished at the start of a calibration procedure. Primary standard. artifact. the process may be performed totally by the instrument or may require user intervention and/or use of external calibrated artifacts.appendix: calibration terminology a to z 1 amount. Selfcalibration may also be called normalization or standardization. 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. Items with similar uses in a production shop are generally regarded as working-level instruments by the calibration program. 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.

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. the GUM specifically does not replace systematic error with either Type A or Type B methods of evaluation. Also called a reference standard. SRMs represent one of the primary vehicles for disseminating measurement technology to industry. (3. according to the type of data available.2. note) See also: bias. correction (of error) Compare with: random error 196 .1) Standardization – See: self-calibration.3. See also: calibration standard Standard operating procedure (SOP) – A term used by some organizations to identify policies. Systematic error may be evaluated by Type A or Type B methods.” Standard uncertainty – The uncertainty of the result of a measurement.3. A device used to transfer the value of a measurement quantity (including the associated uncertainty) from a higher level to a lower level standard. (VIM. The highest level standards.14) Systematic error causes the average of the readings to be offset from the true value. Working standard. Note: Contrary to popular belief. or work instructions.appendix: calibration terminology a to z 1 qualities and whose value is accepted without reference to other standards of the same quantity. Transfer standard. or traceable to. 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. 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. expressed as a standard deviation. Systematic error is a measure of magnitude and may be corrected. procedures. Systematic error is also called bias when it applies to a measuring instrument. The highest accuracy level standards in a particular laboratory generally used only to calibrate working standards. (GUM. error. Secondary standard. 2. are the realizations or representations of SI units. and is accompanied by. A standard that is used for routine calibration of IM&TE. Examples: triple point of water cell and caesium beam frequency standard. found in national and international metrology laboratories. 3.

or another ratio. 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. 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. page 2) TUR =  UUT_tolerance  STD_uncert The TUR must be calculated using identical parameters and units for the UUC and the calibration standard. or another ratio. percentage. uncertainty 197 . (NCSL. it represents the maximum allowable deviation from a specified value. If the accuracy tolerances are expressed as decibels. they must be converted to absolute values of the basic measurement units. If the accuracy tolerances are expressed as decibels. (2) In the normal use of IM&TE items. 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. percentage. A tolerance is a property of the item being measured. Note: TAR may also be referred to as the accuracy ratio or (incorrectly) the uncertainty ratio. Note: The uncertainty of a measurement standard is not necessarily the same as its accuracy specification. Tolerances are applied during design and manufacturing. the TAR is the ratio of the tolerance of the parameter being measured to the accuracy tolerance of the IM&TE. Compare with: specification.appendix: calibration terminology a to z 1 System owner – The person responsible for the availability. (NCSL. Test accuracy ratio – (1) In a calibration procedure. Test uncertainty ratio – In a calibration procedure. and maintenance of a computerised system and for the security of the data residing on that system. page 2) TAR =  UUT_tolerance  STD_tolerance The TAR 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.

6. (NCSL. or industry or other accepted consensus reference standards. capacitors. 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. fundamental or physical natural constants that are reproducible and have defined values. certified standard reference materials. providing the ability to relate the measurement result to stated references. through an unbroken chain of comparisons each having stated uncertainties.8) Typical applications of transfer standards are to transfer a measurement parameter from one organization to another. a calibrated IM&TE. 198 . (VIM. Transfer standard – A transfer standard is a measurement standard used as an intermediate device when comparing two other standards. traceability – Traceability is a property of the result of a measurement. Traceability provides the ability to demonstrate the accuracy of a measurement result in terms of the stated reference. Common transfer methods are differential measurements and ratio measurements. but the report alone is not sufficient. Only the result of a specific measurement can be said to be traceable. Examples of typical transfer standards are DC volt sources (standard cells or zener sources). a measurement system. from a primary standard to a secondary standard. 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. or any other thing is not and be traceable to a national standard. (VIM. ratio type comparisons. and singlevalue standard resistors.appendix: calibration terminology a to z 1 Traceable. A calibration system operating under a program controls system only implies traceability. Evidence of traceability includes the calibration report (with values and uncertainty) of calibration standards. a calibration report. A calibration laboratory. provided all of the conditions just listed are met. Measurement assurance methods applied to a calibration system include demonstration of traceability. or inductors. pages 42–43) The stated references are normally the base or supplemental SI units as maintained by a national metrology institute. Reference to a NIST test number is specifically not evidence of traceability. or from a secondary standard to a working standard in order to create or maintain measurement traceability. 6.10) 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. The laboratory must also apply and use the data.

2. Both random and systematic error may be evaluated by Type B methods. Validation – Substantiation by examination and provision of objective evidence that verified processes. VIM – An acronym commonly used to identify the ISO International 199 . (GUM. UUC. Uncertainty – Uncertainty is a property of a measurement result that defines the range of probable values of the measurand. Both random and systematic error may be evaluated by Type A methods. 3. with a specified level of confidence. Verification – Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. methods. UUT – The unit under calibration or the unit under test – the instrument being calibrated.3 through 3. 2.3. which are used in the text of the calibration procedure for convenience. 3.3. Type B evaluation Uncertainty budget – The systematic description of known uncertainties relevant to specific measurements or types of measurements. See also: Type A evaluation. Also may be called device under test (DUT) or equipment under test (EUT). Type B evaluation (of uncertainty) – Type B evaluation of measurement uncertainty includes any method except statistical analysis of actual measurement results.5) Uncertainty can only be evaluated by Type A methods if the laboratory actually collects the data. range of measurement.3) Uncertainty is an estimate of the range of values that the true value of the measurement is within. and/ or other applicable measurement criteria.3 through 3. effects that contribute to the dispersion may be random or systematic.3. 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. categorized by type of measurement.5) Data for evaluation by Type B methods may come from any source believed to be valid. (GUM.3. After an item that has a specified tolerance has been calibrated using an instrument with a known accuracy. Uncertainty is an estimate of dispersion. and/or procedures are fit for their intended use. the result is a value with a calculated uncertainty. (GUM.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. These are standard generic labels for the IM&TE item that is being calibrated.

(The acronym comes from the French title.) Work Instruction – In a quality management system. In a metrology laboratory. 200 . 2004. a work instruction defines the detailed steps necessary to carry out a procedure.  Bucher. a calibration procedure is a type of work instruction. The level of education and training of the people with the usual qualifications to do the work must be considered when writing a work instruction. 1. Work instructions are used only where they are needed to ensure the quality of the product or service. The Metrology Handbook. Milwaukee: ASQ Quality Press. Jay L.appendix: calibration terminology a to z 1 Vocabulary of Basic and General Terms in Metrology.

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