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 firstname.lastname@example.org. Beamex is a trademark of Beamex Oy Ab. All other trademarks or trade names mentioned in this book are the property of their respective holders.
Graphic design: Studio PAP Photos: Mats Sandström and image bank Printed by: Fram in Vaasa 2012, Finland
REGULATIONS AND TRACEABILITY Quality standards and industry regulations 11 A basic quality calibration program 35 Traceable and efficient calibrations in the process industry 57 CALIBRATION MANAGEMENT AND MAINTENANCE Why Calibrate? What is the risk of not calibrating? 73 Why use software for calibration management? 79 How often should instruments be calibrated? 89 How often should calibrators be calibrated? 97 Paperless calibration improves quality and cuts costs 101 Intelligent commissioning 107 Successfully executing a system integration project 115 CALIBRATION IN INDUSTRIAL APPLICATIONS The benefits of using a documenting calibrator 125 Calibration of weighing instruments Part 1 131 Calibration of weighing instruments Part 2 137 Calibrating temperature instruments 143 Calculating total uncertainty of temperature calibration with a dry block 149 Fieldbus transmitters must also be calibrated 157 Configuring and calibrating smart instruments 163 Calibration in hazardous environments 169 The safest way to calibrate to calibrate Fieldbus instruments 175 APPENDIX: Calibration terminology A to Z 181
Preface by the CEO of Beamex Group 7 QUALITY.
who was the key person in organizing and leading the project for the 2nd edition. A team of experts in industry and calibration worldwide has put forth effort to its creation. how to eliminate double work. calibration procedures need to be automated to a higher degree and integrated to achieve improvements in quality and efficiency. All of these challenges can be tackled by improving the level of system integration and automation. the primary challenges of industrial metrology and calibration include how to simplify and streamline the entire calibration process. how to reduce production down-time. temperature calibration and configuring. and calibration of smart instruments. I hope this book will assist you in learning new things and in providing fresh. Calibration and calibrators can no longer be considered as isolated. stand-alone devices. new ideas.preface by the ceo of beamex group
alibrators. Beamex aims to be the benchmark in the industry. On behalf of Beamex. and how to lower the risk of human errors. Enjoy your reading! raimo ahola. 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. beamex group
. This book is the result of work that has taken place between 2006 and 2012. The new topics covered in the edition mainly discuss paperless calibration. I want to express my special thanks to Pamela at Beamex Marketing. This book is the 2nd edition of Ultimate Calibration. 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. intelligent commissioning. ceo. Just like any other business function. Presently. systems or work processes within a company or production plant. I would like to thank all of the people who have contributed to this book. In this area.
Quality. Regulations and Traceability
(Plato. A. The Republic. PRS. is beautifully restored by measuring.A.quality standards and industry regulations
Calibration requirements according to quality standards and industry regulations
efore going into what the current standards and regulations actually state. Immersion in water makes the straight seem bent. in your thoughts. The Egyptians studied the science of geometry to assist them in the construction of the Pyramids. PC. these drive vague notions of greater or less or more or heavier right out of the minds of the surveyor. 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
. here is a reminder from times past about measurement practices and how important they really are.K. advanced to the stage of science. your knowledge is of a meager and unsatisfactory kind. the Egyptian unit of length came into being.1 One of the earliest records of precise measurement is from Egypt. 1st Baron Kelvin. (Clause 35. but when you cannot express it in numbers. and the clerk of the scales. Magna Carta. the computer. thus confused by false appearance. 26 June 1824–17 December 1907. It is believed that about 3000 years B. but you have scarcely. It may be the beginning of knowledge.) There shall be standard measures of wine..C. Lord Kelvin). OM. and corn… throughout the whole of our kingdom. GCVO. and a standard width of dyed russet and cloth. 1215) When you can measure what you are speaking about and express it in numbers. but reason. Surely it is the better part of thought that relies on measurement and calculation. numbering and weighing. and there shall be standard weights also.C. 360 B. (William Thomson. beer. you know something about it.
standards. traceability and calibration recall. Through the use of cubit sticks. were supplied with cubits made of wood or granite. In roughly 756 feet or 230. However.5 inches or 11. Though the punishment prescribed was severe. if a company is manufacturing a drug that must meet regulatory requirements. there are basically two types of requirements: ISO standards and regulatory requirements. pyramids. The Royal Architect or Foreman of the construction site was responsible for maintaining & transferring the unit of length to workers instruments. The need for calibration has been around for at least 5000 years. they are inspected by government inspectors for compliance to federal regulations.05%. and regulatory requirements are mandatory.36276 meters. In Europe. They were required to bring back their cubit sticks at each full moon to be compared to the Royal Cubit Master. temples.
. In the case of ISO standards.quality standards and industry regulations
finger plus the width of the palm of the hand of the Pharaoh or King ruling at that time. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) aims to improve harmonisation of Good Manufacturing Practice (GMP) standards and guidance documents. Thousands of workers were engaged in building the Great Pyramid of Giza. they were within 4. Workers engaged in building tombs. the Egyptians had anticipated the spirit of the present day system of legal metrology. On the other hand. detailed information for achieving regulatory compliance is provided in Eudralex .43 centimeters. 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. 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). the Egyptians achieved surprising accuracy. The biggest difference between the two is simple – ISO standards are voluntary. they pay a company to audit them to that standard to ensure they are following their quality manual and are within compliance. Failure to do so was punishable by death.Volume 4 of “The rules governing medicinal products in the European Union”.2 The “Royal Cubit Master” was carved out of a block of granite to endure for all times. In today’s calibration environment. they achieved an accuracy of 0. etc. With this standardization and uniformity of length. If an organization volunteers to meet ISO 9000 standards.
75 – Process validation. 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. § 820. § 820.25 – Personnel.1 – Scope. Subpart B – Quality System Requirements § 820. S.3 – Definitions. Subpart G – Production and Process Controls § 820. § 820.70 – Production and process controls.5 – Quality system. § 820. that relate to the calibration of test equipment in different situations and environments. § 820. measuring.
. Food and Drug Administration (FDA) Following are examples of some of the regulations required by the FDA.20 – Management responsibility.50 – Purchasing controls. Please note that European standards are similar to FDA requirements. and test equipment. Subpart F – Identification and Traceability § 820.30 – Design controls.quality standards and industry regulations
Calibration requirements according to the U.60 – Identification.22 – Quality audit. Subpart D – Document Controls § 820. § 820. Subpart C – Design Controls § 820. and what they say about calibration and what must be accomplished to meet the CFRs. Subpart E – Purchasing Controls § 820.65 – Traceability.72 – Inspection.40 – Document controls. § 820. Listed below are several different parts of 21CFR.
200 – Servicing. § 820. § 820. 2012] [CITE: 21CFR820. § 820. § 820. and Installation § 820. Subpart J – Corrective and Preventive Action § 820. § 820. Distribution.186 – Quality system record. Subpart M – Records § 820. in-process. Volume 8] [Revised as of April 1. Subpart O – Statistical Techniques § 820. Subpart L – Handling. Subpart N – Servicing § 820.
[Code of Federal Regulations] [Title 21.250 – Statistical techniques.quality standards and industry regulations
Subpart H – Acceptance Activities § 820. and finished device acceptance. Subpart K – Labeling and Packaging Control § 820.86 – Acceptance status.72] TITLE 2 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H – MEDICAL DEVICES
.100 – Corrective and preventive action.120 – Device labeling.184 – Device history record. Storage.140 – Handling.160 – Distribution. § 820.150 – Storage.170 – Installation.181 – Device master record.180 – General requirements. § 820. § 820. § 820.198 – Complaint files.130 – Device packaging.90 – Nonconforming product. Subpart I – Nonconforming Product § 820.80 – Receiving.
measuring. is suitable for its intended purposes and is capable of producing valid results. When accuracy and precision limits are not met. (b) Calibration. measuring. and storage of equipment. These activities shall be documented. there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment. calibration dates. These activities shall be documented. (2) Calibration records. 820. measuring.
. (1) C alibration standards. automated. Each manufacturer shall ensure that all inspection. or electronic inspection and test equipment. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated.72 Inspection. and test equipment. preservation. and maintained. the manufacturer shall use an independent reproducible standard. Calibration procedures shall include specific directions and limits for accuracy and precision. and test equipment. and the next calibration date shall be documented. The equipment identification. measuring. If national or international standards are not practical or available. If no applicable standard exists. so that its accuracy and fitness for use are maintained. the individual performing each calibration. including mechanical. Calibration standards used for inspection. inspected.quality standards and industry regulations
PART 820–QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls Sec. (a) Control of inspection. checked. and test equipment. The procedures shall include provisions for handling. and test equipment shall be traceable to national or international standards. the manufacturer shall establish and maintain an in-house standard.
or electronic equipment or other types of equipment. quality. 211. packing.160 General requirements. closures.
. 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. mechanical. and purity. or related systems that will perform a function satisfactorily. Laboratory controls shall include: (1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components. in-process materials. drug product containers. strength. 211. standards. and holding of a drug product. Volume 4] [Revised as of April 1. closures. inspected. and electronic equipment. drug product containers. or checked according to a written program designed to assure proper performance. processing. sampling plans. including computers.
Sec. Written records of those calibration checks and inspections shall be maintained. and drug products conform to appropriate standards of identity. it shall be routinely calibrated. and test procedures designed to assure that components. If such equipment is so used. may be used in the manufacture.quality standards and industry regulations
[Code of Federal Regulations] [Title 21. (a) Automatic. labeling. (b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications.68 Automatic. mechanical.
Sept. apparatus. processing. 29. and provisions for remedial action in the event accuracy and/or precision limits are not met. 1978. 8. 211. Sept. gauges. as amended at 73 FR 51932. or closure that is subject to deterioration.quality standards and industry regulations
and labeling used in the manufacture. and recording devices at suitable intervals in accordance with an established written program containing specific directions. packing. Such procedures shall also require appropriate retesting of any component.160(b)(4).
. Samples shall be representative and adequately identified. Such samples shall be representative and properly identified. The specifications shall include a description of the sampling and testing procedures used. gauges. (4) The calibration of instruments. Instruments. or holding of drug products. and recording devices required by 211. schedules. 2008] Sec. (d) Complete records shall be maintained of the periodic calibration of laboratory instruments. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials.
[43 FR 45077.194 Laboratory records. and recording devices not meeting established specifications shall not be used. drug product container. apparatus. apparatus. Such samples shall be representative and properly identified. (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. gauges. limits for accuracy and precision.
quality standards and industry regulations
TITLE 2 – FOOD AND DRUGS CHAPTER I – FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A – GENERAL PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A – General Provisions Sec. 11.1 Scope. (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. (c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997. (d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with 11.2, unless paper records are specifically required.
quality standards and industry regulations
(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection. (f) This part does not apply to records required to be established or maintained by 1.326 through 1.368 of this chapter. Records that satisfy the requirements of part 1, subpart J of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part. [62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004] Sec. 11.2 Implementation. (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. (b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that: (1) The requirements of this part are met; and (2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission. 19
quality standards and industry regulations
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A--GENERAL PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart C – Electronic Signatures Sec. 11.100 General requirements. (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual`s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. (c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 12420 Parklawn Drive, RM 3007 Rockville, MD 20857. (2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer`s handwritten signature.
quality standards and industry regulations
Calibration requirements according to the European Medicines Agency (EMA) Following are examples of some of the regulatory requirements of the EMA, and what they say about calibration and what must be accomplished to meet the GMPs. Eudralex Volume 4 Chapter 3: Premises and Equipment Equipment 3.41 Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained. Chapter 4: Documentation Manufacturing Formula and Processing Instructions Approved, written Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured. 4.18 The Processing Instructions should include: a) A statement of the processing location and the principal equipment to be used; b) The methods, or reference to the methods, to be used for preparing the critical equipment (e.g. cleaning, assembling, calibrating, sterilising); c) Checks that the equipment and work station are clear of previous products, documents or materials not required for the planned process, and that equipment is clean and suitable for use; d) Detailed stepwise processing instructions [e.g. checks on materials, pre-treatments, sequence for adding materials, critical process parameters (time, temp etc)]; e) The instructions for any in-process controls with their limits; f ) Where necessary, the requirements for bulk storage of the products; including the container, labeling and special storage conditions where applicable; g) Any special precautions to be observed.
cleaning or repair operations. • Environmental monitoring. • Pest control. maintenance. • Complaints. reports and the associated records of actions taken or conclusions reached. • Technology transfer. equipment and systems. • Investigations into deviations and non-conformances. They should be used to record in chronological order. • Supplier audits. including the dates and identity of people who carried these operations out. • Internal quality/GMP compliance audits.g. • Recalls. calibrations. procedures. product quality review). • Summaries of records where appropriate (e.quality standards and industry regulations
Procedures and records Other 4. clothing and hygiene and verification of the effectiveness of training. • Returns. production equipment. • Personnel matters including signature lists. cleaning and sanitation. and areas where product has been processed. where appropriate.31 Logbooks should be kept for major or critical analytical testing. • Maintenance. for the following examples: • Validation and qualification of processes. equipment/method. as appropriate. protocols. • Equipment assembly and calibration.29 There should be written policies. • Change control.
. 4. any use of the area. training in GMP and technical matters.
. (c) icalibration requirements. • validation records of test methods. • procedures for and records of the calibration of instruments and maintenance of equipment. (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. but not be limited to the following: (a) installation of equipment. where applicable. • data from environmental monitoring. • sampling procedures. 12. • analytical reports and/or certificates.quality standards and industry regulations
Chapter 6 Quality Control Good Quality Control Laboratory Practice Documentation 6. (d) verification of materials of construction. Installation qualification (IQ ) should be performed on new or modified facilities. piping. services and instrumentation checked to current engineering drawings and specifications. • testing procedures and records (including analytical worksheets and/ or laboratory notebooks). where required. An important part of this documentation deals with Quality Control and the following details should be readily available to the Quality Control Department: • specifications. systems and equipment.7 Laboratory documentation should follow the principles given in Chapter 4. IQ should include.
(i) methods for recording and evaluating results (j) functions and responsibilities. operating procedures and operator training procedures and records should be documented. systems and equipment 19. Additionally. (f) proposed in-process controls with acceptance criteria.quality standards and industry regulations
Operational qualification 15. (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. systems and equipment. Qualification of established (in-use) facilities. the calibration. with acceptance criteria and analytical validation. operating and cleaning procedures. (k) proposed timetable.
. It should permit a formal “release” of the facilities. Prospective validation should include. The completion of a successful Operational qualification should allow the finalisation of calibration. operator training and preventative maintenance requirements. preventative maintenance. as appropriate. Evidence should be available to support and verify the operating parameters and limits for the critical variables of the operating equipment. (g) additional testing to be carried out. as appropriate. (h) sampling plan. but not be limited to the following: (a) short description of the process. (b) summary of the critical processing steps to be investigated. (e) list of analytical methods. cleaning. PROCESS VALIDATION Prospective validation 24.
PDF of Annex 11:
http://ec.eu/health/documents/eudralex/vol-4/index_en.eu/health/files/eudralex/vol-4/annex11_01-2011_ en. SANCO/C8/AM/sl/ares(2010)1064599 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. Main page for the EudraLex . This document provides guidance for the interpretation of the principles
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels.europa.Volume 4 Good manufacturing practice (GMP) Guidelines:
http://ec.europa. and applies to all forms of computerised systems used as part of GMP regulated activities.quality standards and industry regulations
EU GMP Annex 11 The EU GMP Annex 11 defines EU requirements for computerised systems.
there should be no resultant decrease in product quality. A computerised system is a set of software and hardware components which together fulfill certain functionalities. B-1049 Bruxelles / Europese Commissie. 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. Where a computerised system replaces a manual operation.org/. B-1049 Brussel . 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. There should be no increase in the overall risk of the process. IT infrastructure should be qualified. It aims to promote harmonisation of global regulations for the pharmaceutical industry.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. Consequential amendments are also proposed for Chapter 4 of the GMP Guide. Deadline for coming into operation: 30 June 2011 Commission Européenne. process control or quality assurance. picscheme.
. Further information can be found at the PIC/S Web site (http://www. The application should be validated.).quality standards and industry regulations
and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.
The most well known GAMP® publication is GAMP ® 5 A RiskBased Approach to GxP Computerized Systems. 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 . Since 1994. Switzerland). COPs provide networking opportunities for people interested in similar topics. 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.A Companion Volume to GAMP® 5 • GAMP® Good Practice Guide: Electronic Data Archiving • GAMP® Good Practice Guide: Global Information Systems Control and Compliance
. and GAMP® Americas support the GAMP® Council which oversee the operation of the COP and is the main link to ISPE. The GAMP® COP organizes discussion forums for its members and ISPE organises GAMP® related training courses and educational seminars. There is also a series of related GAMP® guidance on specific topics. GAMP® Francophone. Austria. Several local GAMP® COPs. GAMP® Italiano and GAMP® Japan. GAMP® DACH (Germany. such as GAMP® Americas. They also bring the GAMP® community closer to its members.quality standards and industry regulations
GAMP® GAMP® is a Community of Practice (COP) of the International Society for Pharmaceutical Engineering (ISPE). This is the latest major revision and was released in January 2008. GAMP® Europe. the organization entered into a partnership with the ISPE and published its first GAMP® guidelines. GAMP® Japan. Three regional Steering Committees. produce technical content and translate ISPE technical documents. The GAMP® COP aims to provide guidance and understanding concerning GxP computerized systems. in collaboration with ISPE’s local Affiliates in these regions.
• Calibrate your monitoring and measuring equipment using a period schedule to ensure that results are valid (you should also perform a yearly evaluation of your calibration results to see if there is a need to increase or decrease your calibration intervals on calibrated test equipment). ISO 9001:2008 Basically. A set of associated attachments are also available through the ISPE website. All calibrations must be traceable to a national or international standard or artifact. • Establish monitoring and measuring processes (calibration procedures and calibration record templates for recording your calibration results). and select test equipment that can meet those monitoring and measuring needs and requirements.
. and corrective actions vital to regulatory compliance. this is what is required according to ISO 9001:2008 7. providing a structured approach to instrument risk assessment. laboratory. The Guide describes the principles of calibration and presents guidance in setting up a calibration management system. The second edition of the guide has been significantly updated to address the change in regulatory expectations and in associated industry guidance documents. The scope now includes related industries. and analytical instrumentation. 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. calibration program management.6 CONTROL MONITORING AND MEASURING EQUIPMENT • Identify your organization’s monitoring and measuring needs and requirements (if your test instrument makes a quantitative measurement. documentation.
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”. then you do not have any obligation to meet the ISO 17025 standard. your test instruments may need to be qualified prior to use). and third-party laboratories. You already fall under a quality system that takes care of your calibration requirements. and when required. ANSI/NCSL Z540. transportation. “When accuracy and precision limits are not met. and laboratories where testing and/or calibration forms part of inspection and product certifications. this standard is applicable to all organizations performing tests and/or calibrations. rather it be for compliance to an ISO standard (ISO 9001:2008 or ISO 13485) or an FDA requirement (cGMP. preservation.
. and shipping of all test instruments – to include your customer’s items.3-2006 ANSI/NCSL Z540.3-2006 – American National Standard for Calibration-Requirements for the Calibration of Measuring and Test Equipment. especially when the out of tolerance item is a calibration standard. etc.quality standards and industry regulations
• Protect your monitoring and measuring equipment (this includes during handling. These include first-. and may have affected numerous items of test equipment over a period of time).). this is just as applicable when dealing with ISO as with any other standard or regulation. storage. Please keep in mind that if your calibration function and/or metrology department fall under the requirements of your company. QSR. According to ISO 17025. • 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. • Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out-ofcalibration (as stated in the FDA regulations. and your calibration standards). ISO 17025 ISO 17025 – General requirements for the competence of testing and calibration laboratories. second-.
• the compatibility of measurements with the National Measurement System. and • balancing the needs and interests of all stakeholders. and government standards. or information. service. This National Standard is written for both Supplier and Customer. certification. Reference to this National Standard may be made by: • customers when specifying products (including services) required. 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 • the traceability of measurement results to the International System of Units (SI). In implementing its objective. each term being interpreted in the broadest sense. Part 11 of ANSI/NCSL Z540. • agencies or organizations as a contractual condition for procurement. • applying best practices and experience with related national. • the suitability of a calibration for its intended application. retailer. This is done through the use of a system of functional components. international. vendor. • suppliers when specifying products offered. or a provider of a product. distributor. • legislative or regulatory bodies. enduser. and other evaluations of calibration systems and their components. this National Standard describes the technical requirements for establishing and maintaining: • the acceptability of the performance of measuring and test equipment. client.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. industry. 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. or purchaser that receives a product or service.1 (R2002) and Military Standard 45662A. this National Standard includes and updates the relevant calibration system requirements for measuring and test equipment described by the previous standards. Collectively. and • assessment organizations in the audit.
. The “Customer” may be a consumer. In addition. The “Supplier may be a producer.
quality standards and industry regulations
This National Standard is specific to calibration systems. A calibration system operating in full compliance with this National Standard promotes confidence and facilitates management of the risks associated with measurements, tests, and calibrations.8 Equipment intended for use in potentially explosive atmospheres (ATEX) What are ATEX and IECEx? ATEX (“ATmosphères EXplosibles”, explosive atmospheres in French) is a standard set in the European Union for explosion protection in the industry. ATEX 95 equipment directive 94/9/EC concerns equipment intended for use in potentially explosive areas. Companies in the EU where the risk of explosion is evident must also use the ATEX guidelines for protecting the employees. In addition, the ATEX rules are obligatory for electronic and electrical equipment that will be used in potentially explosive atmospheres sold in the EU as of July 1, 2003. IEC (International Electrotechnical Commission) is a nonprofit international standards organization that prepares and publishes International Standards for electrical technologies. The IEC TC/31 technical committee deals with the standards related to equipment for explosive atmospheres. IECEx is an international scheme for certifying procedures for equipment designed for use in explosive atmospheres. The objective of the IECEx Scheme is to facilitate international trade in equipment and services for use in explosive atmospheres, while maintaining the required level of safety. In most cases, test equipment that is required to be operated in an explosive environment would be qualified and installed by the company’s facility services department and not the calibration personnel. One must also keep in mind that there would be two different avenues for the calibration of those pieces of test equipment: on-site and off-site. If the test instrument that is used in an explosive environment must be calibrated on-site (in the explosive environment), then all the standards used for that calibration must also comply with explosive environment directives. However, if it were possible to remove the test equipment from the explosive environment when due for their period calibration, then there would be no requirement for the standards used for their calibration to meet the explosive
quality standards and industry regulations
environment directives, saving money on expensive standards and possibly expensive training of calibration personnel in order for them to work in those conditions. Having said that, there may be a need for the calibration personnel to be aware of the ATEX regulations. An informative website for information on ATEX can be found by typing in the following link: http://ec.europa.eu/enterprise/atex/indexinfor.htm. Several languages are available for retrieving the information. Another informative website is the International Electrotechnical Commission Scheme for Certification to Standards Relating to Equipment for use in Explosive Atmospheres (IECEx Scheme). The link is: http://www.iecex.com/guides.htm. 1. Bucher, Jay L. 2007. The Quality Calibration Handbook. Milwaukee: ASQ Quality Press. 2. The Story of the Egyptian Cubit. http://www.ncsli.org/misc/ cubit.cfm. (18 October, 2008) 3. 21CFR Part 211.68, 211.160: http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211/ (5 July, 2012) 4. 21CFR Part 11. http://www.fda.gov/downloads/ RegulatoryInformation/Guidances/ucm125125.pdf (5 July, 2012) and http://www.fda.gov/RegulatoryInformation/Guidances/ ucm125067.htm?utm_campaign=Google2&utm_ source=fdaSearch&utm_medium=website&utm_term=21 CFR part 11&utm_content=3 5. GAMP. http://en.wikipedia.org/wiki/Good_Automated_ Manufacturing_Practice (5 July, 2012) 6. NCSL International. 2006. ANSI/NCSL Z540.3-2006. Boulder, CO.
a basic quality calibration program
A basic quality calibration program
&D departments are tasked with coming up with the answers to many problems. The company loses time. A fairy tale? Not hardly. the cure for cancer is one of them. for food weighed incorrectly at the checkout counter. If all test equipment were calibrated to a traceable standard. having the correct measurements throughout any and all industries is critical to national and international trade and commerce. Crime labs cannot identify the remains of victims or wrongly identify victims in the case of mass graves. criminals are either not convicted or are released on bad evidence. which weight is correct? As one can see. The cure cannot be replicated with consistent results. and for manufactured goods that do not meet their stated specifications. They are not using calibrated test instruments in the company. Incorrect amounts of ingredients in your prescription and over-the-counter (OTC) drugs can cost more. Their R&D section sends the formula to their operations & manufacturing division. Airliners fly into mountaintops and off the ends of runways because they don’t know their altitude and/or speed. or by using incorrect calibrations. Babies are not correctly weighed at birth. 35
. This scenario is repeated every day throughout the world. then repeatable results would ensure that what’s made in one part of the company is also repeated in another part of the company. Let’s imagine that the Acme Biotech Co. and possibly the ability to stay in business simply because they do not use calibrated test equipment. or even cause illness or death. money. Without calibration. has found the cure for cancer. their reputation. Measurements made by R&D are different than those made by the operations section. The amount of drugs confiscated in a raid determines whether the offense is a misdemeanor or a felony. all of us pay more at the gas pump. Because of poor or incorrect calibration.
and the unit under test (UUT) or test instrument that is being calibrated (the uncertainty is unknown. By definition: Calibration is a comparison of two measurement devices or systems. First. However. When we talk about traceability to a national or international standard. Many people are under the misconception that an item must be adjusted or aligned in order to be calibrated.a basic quality calibration program
The bottom line is this – all test equipment that make a quantitative measurement require periodic calibration. usually national or international standards. Traceability is the property of the result of a measurement or the value of a standard whereby it can be related to stated references. the purpose of which is to give guidance on the calibration and maintenance of measuring
. Before we can get any deeper into what traceability is. and using a test uncertainty ratio (TUR) of ≥ 4:1. one of known uncertainty (your standard) and one of unknown uncertainty (your test equipment or instrument). The two examples in figures 1 and 2 are similar. we need to clarify two definitions that are critical to this subject – calibration and traceability. through an unbroken chain of calibrations all having stated uncertainties. According to the European cooperation for Accreditation of Laboratories. The comparison to a standard that is more accurate. nor if you cannot adjust or align it. It is as simple as that. align or repair the item. let’s discuss the use of uncertainty budgets. There are basically two ways to maintain traceability during calibration – the use of an uncertainty budget (performing uncertainty calculations for each measurement). no matter the circumstances is called calibration. the ‘everyday calibration technician’ is usually situated close to the bottom of the pyramid. Nothing could be further from the truth. and that is why it is being calibrated). so a graphic illustration of these pyramids is important. publication reference (EAL-G12) Traceability of Measuring and Test Equipment to National Standards. we should explain two different traceability pyramids. The calibration of any piece of equipment or system is simply a comparison between the standard being used (with its known uncertainty). but differ depending on where you are in the chain. before we go any further. or certain parts of the world. It does not make any difference if you adjust.
. and the EN 45001 standard for the operation of testing laboratories. and customers who install them with other parts. must measure with the ‘same measure’. paragraphs 4 and 5 are very specific in their requirements: 4 Why are calibrations and traceability necessary? 4. supplier firms that make products.a basic quality calibration program
BIPM NMIs Reference standards Working metrology labs General purpose calibration labs (inside a company) User’s test equipment
SI units Primary stds. Secondary standards Reference standards Working standards User’s test equipment
Note: NMI = National Metrology Institute
equipment in meeting the requirements of the ISO 9000 series of standards for quality systems.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.
a basic quality calibration program
4. the laboratories or bodies performing one or more steps in the chain must supply evidence for their technical competence. way of use.1 Traceability is characterised by a number of essential elements: (a) an unbroken chain of comparisons going back to a standard acceptable to the parties. by demonstrating that they are accredited. 4. (e) reference to SI units. (d) competence.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. uncertainty required. 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. e. e. 4. 5 Elements of traceability 5. if they are used properly. the length of these intervals will depend on a number of variables. each step in the chain must be performed according to documented and generally acknowledged procedures. frequency of use. (b) measurement uncertainty.g.3 If it becomes necessary to prove absence of liability. was in proper working order and was used correctly for controlling a product. by reference to a systematic and fully documented system. the results must equally be documented. usually a national or international standard. (c) documentation. (f) re-calibrations. Note: If binding requirements for the accuracy of measuring and test equipment have been stipulated.g. failure to meet these requirements means the absence of a warranted quality with considerable consequent liability. stability of the equipment. the chain of comparisons must end at primary standards for the realization of the SI units. 38
. calibrations must be repeated at appropriate intervals.2 There are legal as well as technical reasons for traceability of measurement. that adequate measuring and test equipment was chosen. is not affected by defects. 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. the producer must be able to demonstrate.
2 In many fields. the TUR shall be equal to or greater than 4:1. To maintain traceability. and uncertainty calculations were performed and their uncertainty stated on the certificate of calibration. Keep in mind that a TUR of 4:1 somewhere along the chain of calibrations may not have been feasible. The purpose of this document is to harmonise evaluation of uncertainty of measurement within EA. then traceability is assured. As the rules laid down in this document are in compliance with the recommendations of the Guide to the Expression of Uncertainty in Measurement. without using uncertainty budgets or calculations. Expression of the Uncertainty of Measurement in Calibration. In most circumstances. This is correct and acceptable. to set up.1 The other document that goes hand-in-hand with this is EA 4/02.a basic quality calibration program
5.2 By understanding and following both of these documents. Where does this ratio of four to one (4:1) come from? It comes from the American National Standard for Calibration – (ANSI/NCSL Z540. is at the company or shop level. where the customer’s test
. 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. Certification of reference materials is a method that is often used to demonstrate traceability to SI units.” So. reference materials take the position of physical reference standards. the implementation of EA-4/02 will also foster the global acceptance of European results of measurement. in addition to the general requirements of EAL-R1. where the need to maintain a TUR of 4:1 comes into play. you must ensure your standards are at least four times (4:1) more accurate than the test equipment being calibrated. if a TUR of equal to or greater than 4:1 is maintained. 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.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. published by seven international organisations concerned with standardisation and metrology.
Once stability and consistency are achieved. and the appropriate documentation completed to show that training
. 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 calibration technician must be trained on the change before they can perform the calibration. more economical way to perform a specific calibration. Of course not. The effective operation of such a system will hopefully result in stable processes and.3 Let’s take for example a calibration program that has six calibration technicians on staff. 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. Four of them work in another facility calibrating the same types of equipment as the other two. then this would not have happened. They have calibrated the same items for several years and feel there is nothing new to learn. 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. If a change has been made to that procedure. The two ‘old timers’ have a reduction in their production and actually cost the company money. But they must have their calibration procedure on hand each time they are performing the calibration. in a consistent output from those processes. This is applicable in every phase of a production and/or manufacturing program. The four calibration technicians that have been following the calibration procedure improve their production and save the company money. If everyone was using the calibration procedures like they were supposed to. One of the four calibration technicians (who are always following the calibration procedures) finds there is a fast. therefore. They submit a change proposal for the calibration procedure and everyone is briefed and trained on the new technique. But especially true in a metrology department. it is possible to initiate process improvements. 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.a basic quality calibration program
equipment is usually used for production or manufacturing purposes only. However.
“Check the results” means make certain the test equipment meets the tolerances. Here is an example of common formatting for SOPs:
. or recall a product. “Do what you say” means follow the documented procedures or instructions every time you calibrate. 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). Check the results. This includes calibration procedures. These items are also referred to by other standards (ISO 9000.a basic quality calibration program
was accomplished and signed off. or perform a function that follows specific written instructions. The basic premise and foundation of a quality calibration program is to “Say what you do. Record what you did. One of the most stringent requirements can be found in the current Good Manufacturing Procedures (GMP). Do what you say. change a process. etc. work instructions and standard operating procedures (SOPs). When the proper training is not documented and signed off by the trainer and trainee. This includes calibration procedures. All of your calibration procedures should be formatted the same as other SOPs within your company. work instructions and SOPs. “Act on the difference” means if the test equipment is out of tolerance. Let’s break these down into simple terms. or upper/lower limits specified in your procedures or instructions. then it is the same as if the training never happened. “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. “Record what you did” means that you must record the results of your measurements and adjustments. and Act on the difference”. including what your standard(s) read or indicated both before and after any adjustments might be made.3 “Say what you do” means write in detail how to do your job. you’re required to inform the user/owner of the equipment because they may have to re-evaluate manufactured goods. accuracies.
a basic quality calibration program
1. A complete calibration must be performed prior to any adjustment or alignment. micrometers. Have a system in place for updating your
. you should have a table listing all of the instruments or systems that would be calibrated by that procedure. They should show what standards accomplish the calibration of a specific range and/or function. Generic SOPs are written to show how to calibrate a large variety of items in a general context. “Do what you say” means follow the documented procedures or instructions every time you calibrate. Forms and Records 8. two types of calibration procedures: Generic: temperature gages and thermometers. 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. Possibly. Definitions 5. Procedures. power supplies and water baths. Related Procedures 7. This table should also include the standard’s range and specifications. pressure and vacuum gages. There are. thermal cyclers. the calibration form is designed to follow specific steps (number wise). Specific: spectrophotometers. Manufacturer’s manuals usually provide an alignment procedure that can be used as a template for writing a calibration procedure. Procedure 6. Scope 3. Then the actual calibration procedure starts in section 5. along with their range and tolerances. After that you should have a list of the standards to be used to calibrate the items. and balances/scales. Definitions. This means following published calibration procedures every time you calibrate a piece of test equipment. Procedures 2. Document History After section 4. and removes doubt by the calibration technician on what data goes into which data field. Responsibilities 4. pipettes. Have the latest edition of the procedure available for use by your calibration technicians. generally speaking. Specific SOPs are written to show stepby-step procedures for each different type of test instrument within a group of items. or perform a function that follows specific written instructions.
g. e. There should be a place to show what the standard read. The location of where the test instrument can be found should also be on the record. Of course there are many ways to accomplish this. Train your technicians on the changes made to your procedures every time the procedure is changed or improved – and document the training. as well as the test instrument’s ‘As Found’ and when applicable ‘As Left’ readings. The ‘As Found’ readings are what the test instrument read the first time that a calibration is performed. including: • pen and paper • “do-it-yourself ” databases. The entire calibration is performed to see any part of the calibration is out of tolerance.a basic quality calibration program
procedures. their part number and range/tolerance. adjustment or repair. If an out-of-tolerance (OOT) condition is found. and keep your calibration records in a secure location. including what your standard(s) read or indicated both before and after any adjustments are made. or update your calibration procedures and/or forms? A formal. the last time it was calibrated. prior to alignment.
. written process must be in place. The date of calibration. 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. A history of each calibration and a traceability statement or uncertainty budget must be included. What do you do when you need to make an improvement. Excel. Certain requirements must be documented in each calibration record. 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. and the next time it will be due calibration should be on the form.
there would not be a problem since it was found to be in tolerance during the first calibration. and an ‘As Left’ set of data is collected. This should be noted in the calibration record. there is a good possibility that the adjustment affected other ranges or parts of the calibration. while still meeting its specifications. It would be obvious that something happened during the cleaning. it might be metrology department policy to adjust an item if it is more than ½ beyond its in-tolerance range. This is a best practice policy that has been in use in the metrology community since calibration started. If the item is found to be out-of-tolerance at that time. but you would not have been able to collect the original “As Found’ readings. The calibration is performed. The water bath is set to a predetermined temperature. There will be times when an instrument has a catastrophic failure. This is why the entire calibration is performed prior to adjustment or alignment. then proceed with the calibration. make an adjustment. If one were to stop at the point where an OOT is found. after the UUT is adjusted to be as close to optimum as possible. In this type of situation. collecting the ‘As Found’ data. there will be times when this is not possible. or adjustment. The standard reading. alignment or adjustment and that after a final adjustment was completed to bring the unit back into tolerance. from the working or reference standard you are using to calibrate the UUT. once the problem is found and repaired. alignment. an ‘As Found’ calibration is performed. It just dies and cannot be calibrated. a complete calibration is again performed. Compare this to the calibration of pressure gages where a pressure standard is set to a standard pressure. and the temperature standard is used to record the actual reading. will also be recorded on the calibration form. Another example would be when preventive maintenance inspection is going to be performed on an item. Then the PMI is completed.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. Usually. Then. In some circumstances.
. However. “As Left” readings are taken after repair. the standard is set at a predetermined output. One example when it would not be practical to set the standard and take a reading is during the calibration of water baths. and the UUT is read to see how much it deviates from the standard. a final ‘As Left’ calibration would be performed. collecting the ‘As Left’ readings for the final calibration record. Not all UUTs would be considered OOT when “As Left’ readings are taken. The UUT is treated the same as any OOT unit.
dust. then a formal program must be in place for tracking those conditions and reviewing the data. along with the standard.”5 If the conditions within the area that calibrations are being performed require monitoring according to the standard or requirements that must be met. monitored. etc. or in the case of most companies in the USA.a basic quality calibration program
and the gage(s) under test are then read. They.3-2006. plus their specifications and range. Note: Influencing factors and conditions may include temperature. There must be a statement showing traceability to your NMI. then there should be a place in the calibration form for showing that those conditions were 45
. In other case. and mitigated to meet calibration process requirements. or to any artifact that was used as a standard. along with the procedure’s revision number.6 Influence factors and conditions: “All factors and conditions of the calibration area that adversely influence the calibration results shall be defined. Calibration shall be stopped when the adverse effects of the influence factors ad conditions jeopardize the results of the calibration.3. and compared to the standard to see if they are in or out of tolerance. Also on the calibration form should be an area to identify the standard(s) that were used. 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. are placed in a dry block and a particular temperature is set. along with their next calibration due date(s). to NIST. As can be seen by the above examples. List environment conditions when appropriate and show if they pass or fail. and their pressures recorded on the calibration record. The same happens when calibrating thermometers. it is not always possible to set the standard and take a reading from the UUT. There should also be a place to identify which calibration procedure was used. vibration. electromagnetic interference.”4 According to ANSI/NCSL Z540. or at least a statement that a TUR of ≥ 4:1 was met. The UUT is compared to the reference after equilibration. just as the calibration of autoclaves. According to NCSL International Calibration Control Systems for the Biomedical and Pharmaceutical Industry – Recommended Practice RP-6. If this is the case. You should include any uncertainty budgets if used. humidity. paragraph 5. recorded. and a determination is made as to the in or out of tolerance of the UUT.11: “The calibration environment need be controlled only to the extent required by the most environmentally sensitive measurement performed in the area. paragraph 5.
the calibration record must be signed and dated by the technician performing the calibration. draw a single line through the entry. The user/customer. etc. etc. • The user/customer was notified and the UUT was taken out of service and tagged as unusable. after recording your results. manager. or are not applicable to that calibration. If this is the case. What do you do if. even if internal to the company performing the calibrations. You should indicate on the form if the calibration passed or failed. audited. In some instances. then there should be a place to show what happened to the UUT. you find that you have made an error. use whatever tracking system the software uses. there should be a place on the form for the final reviewer to sign and date. and date and sign accordingly. write the correct data. with the following possibilities as an example: • The user/customer was notified and the UUT was adjusted and meets specifications. must be informed if their test equipment does not meet their specifications. or inspected before it is considered a completed record. OOT conditions. For making corrections to electronic records (eRecords).a basic quality calibration program
either met. If the UUT had an out-of-tolerance condition. There should be only one way to file your records. This is called for in all of the standards and regulations. and want to correct the error? For hard copy records. There should be an area set aside in the calibration form for making comments or remarks. the calibration record requires a ‘second set of eyes’. both hard copy
. This means that an individual higher up the chain of command (supervisor. were not met. • The user/customer was notified and the UUT was given a ‘limited calibration’ with their written approval. or make a duplicate record from scratch with the correct data and explain in the comments block what happened. and then place your initials and date next to the data using black ink. Notice that in each circumstance that the user/customer must be notified of any and all OOTs. or erase the original data. Enough space should be available for the calibration technician to include information about the calibration. what was accomplished if an OOT was found. And finally.) must review the calibration record and also sign and date that it has been reviewed. or transposed the wrong numbers. QA inspector. Do not use white-out.
but also new problems in how to collect. and/or compilation into your forms. There are various ways to do this.a basic quality calibration program
and eRecords – no matter which system you use. manage. Calibration forms should have the range and their tolerances listed for each piece of test equipment being calibrated. validation of that software is mandatory.
. In some instances it is apparent what the tolerances will be for the items being calibrated. put it into your written procedures. or through the use of calibration software. or upper/lower limits specified in your procedures or instructions. and eventual storage. How is the data collected and stored? Is it in its native format or dumped into a spreadsheet for analysis? All of these need to be considered to allow for review. 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. “Check the results” means make certain the test equipment meets the tolerances. In other cases it is not quite so apparent. calibration certificate number and calibration date • Placed on a secure drive that has regular backup • eRecords are filed within a specified time frame There are many different ways to manage your calibration data since there are a variety of ways to collect that data. etc. It cannot be emphasized enough the criticality of validating your software. Hard copy records collected during the calibration of test instruments have been discussed in detail already. data lines and storage systems when going entirely electronic with your calibration records and data management. Is the system validated and instrumentation qualified prior to use? If you are using any type of computerized system. The use of computerized data collection brings with it not only increased productivity and savings in time and effort. analysis. But the collection of data by electronic means.. review and store the data. accuracies. process controllers. should also be considered.
you must inform the user because they may have to re-evaluate manufactured goods.a basic quality calibration program
“Act on the difference” means if the test equipment is out of tolerance. or upper management notification in case of ‘in action’?
. 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. change a process or procedure. • Are there any databases that need to be updated. According to the FDA: “When accuracy and precision limits are not met. and a paper trail for historical reference? After owner/user notification. 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. supervisor or manager? • Is a data base maintained on all OOT test equipment? • Is the customer/user required to reply to the OOT notification. 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.
• During an audit/inspection (both internal and external) access to past OOT data should be easily available. • Among the 15% that are found to be OOT some will be due to
Typical calibration process as shown in a flow chart
‘As found’ test
Save ‘As found’ results
Adjust as needed
‘As Left’ test
Save ‘As Left’ results
. • Access to OOT data can assist in determining reliability of test equipment. Here is a hypothetical example: from an historical perspective. generally 85% of test equipment passes calibration.a basic quality calibration program
Do you have a database of all OOT test equipment for various activities? • The database can be used for accessing yearly calibration interval analysis.
According to most standards and regulations. Without any one of these programs. items that are OOT. any software program used must be validated prior to implementation. a comprehensive calibration analysis program. and the ability to see all items that are currently overdue calibration. and a visible safety program. etc. you can schedule your technicians. bad cables/accessories. Do what you say. Developing a world-class calibration program A quality calibration program might be compared to an iceberg. check that the proper specifications are being used. Check the results. But the different parts that keep a quality calibration program running efficiently consist of elements from a continuous process improvement program. Record what you did. By knowing what is coming due calibration. This can be accomplished using the manufacturer’s
. poorly written calibration procedures. the ability to see a 30 day schedule of items coming due calibration. correct and properly used calibration and equipment labels. along with traceability should be apparent to an auditor or inspector. groups of items by location/part number. Only about 10% can be easily seen by the casual observer. From a managerial standpoint. Those include: a master inventory list. and Act on the difference” portion. and other listings that help to manage your department. However. scheduling and calibration management software. Having an effective calibration management program is usually the difference between being proactive and reactive to performing your routine calibrations. environmental conditions (vibration. before changing calibration intervals. standards. • If a higher fail rate is noticed. the unseen portion is what keeps the iceberg afloat and stable in the ocean. the calibration management program should also be able to show calibrations and repairs by individual items. The “Say what you do. reverse traceability. a quality calibration program would be impossible to maintain. bad standards. The same can be said of a quality calibration program. an effective training program.). Any calibration management program worth the money should have a few critical areas built into their basic program. time and other resources to the best advantage. This can be compared to the person who is trying to drain the swamp while fighting off the alligators. 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 basic quality calibration program
A best practice among experienced calibration practitioners is the calibration of like items. and the calibration technician is required to gown-up prior to entry every time then go into the clean-room. your validation paperwork needs to be available for inspection during audits and inspections. Calibration interval analysis software can be purchased commercially
. This would be using your time to the best advantage. Also. An example would be to start all temperature calibrations (set water baths up for their initial temperature readings). say outdoors in severe weather. and using your scheduling software to also perform calibrations in geographical areas or combining calibrations in local areas. 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. depending on usage. or used as an item that is coded as “No Calibration Required” on a loading dock. then scheduling all of the calibrations in that area could increase production and reduce down time from multiple entries and exits. you must consider if the test equipment is used to determine final product where specifications are very tight. etc. Most manufacturers recommend a 12 month calibration interval. An example of this would be to calibrate all pressure gages that were shown to be stored or used in a specific area. Either way.a basic quality calibration program
system. then perform several pipette or balance calibrations. Another critical yet often times misunderstood program is calibration interval analysis. Also. A particular item used in a controlled environment should be more reliable that one used in a harsher situation. return to finish the pipette or balance calibrations. or floor of a building. Combining the calibration of like items and mixing and matching items could reduce the task of mundane and boring calibrations. return to set another temperature in the water baths (doing a few at a time). Each situation should be considered carefully so that they can be reviewed in the appropriate light. or by incorporating an in-house validation system. By not having to stand around to wait for the water baths to equilibrate. and keeping the calibration technician involved and focused instead of bored. if calibrations were to be performed in a ‘clean room’ environment. increasing productivity. then complete the water baths at their final setting. you are using your time more efficiently. handling. environment.
. but one of the foundations for any quality system in the 21st century. recalls can be very expensive. implement and manage calibration interval determination. 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. Not only is calibration a requirement. adjustment and evaluation programs. It provides information needed to design. On one side we have the requirement of standards and regulations that govern various companies.a basic quality calibration program
and used to evaluate your test equipment. Here is an example. The advantages and disadvantages of each method are described and guidelines are given to assist in selecting the best method for a requiring organization. industries and even countries. Establishment & Adjustment of Calibration Intervals. A company could also do their own analysis if they support a limited number of items. set a cut off for increasing or decreasing calibration intervals • Consider increasing a calibration interval if the pass rate ≥ 95% (by ½ up to double the current calibration interval) • Consider decreasing a calibration interval if the pass rate ≤ 85% (by ¾ to ½ of the current calibration interval) No matter which route you take for calibration interval analysis – ensure you are on the cutting-edge – not on the ragged-edge by extending your intervals too fast without solid data. Also. • For each type of equipment. divide result by the number of calibrations. It isn’t a question of do you have a quality calibration program in place. then take the result times 100 for the pass rate • Make a risk assessment of each item for your company’s needs. in time and money. or are on a tight budget and are willing to do their own computations. Several methods of calibration interval analysis and adjustment are presented. This Recommended Practice (RP) is intended to provide a guide for the establishment and adjustment of calibration intervals for equipment subject to periodic calibration. 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. Both management and technical information are presented in this RP.
Then you can say you have a quality calibration program. continuous process improvements. documented training for all your calibration technicians. or quantity. calibration interval analysis. But it doesn’t end there.a basic quality calibration program
does it comply with all the requirements of the appropriate standard or regulation to which your company must conform? The other side of the double edged sword is having a calibration program in place without any type of quality. so the company would never be able to stay in business long enough to impact their market segment. and the ability to provide quality customer service in a timely manner. pharmaceutical drugs and products that impact human safety – the cost could be immeasurable…with the possibility of death among the results. Without calibration to a traceable standard (national. a training program. traceable documentation. a comprehensive calibration management software package. Referring to a double edged sword. The basic belief is this – it is absolutely essential to have a quality calibration program in place to make a quality product. there can be no repeatability. This would equate to not having any type of calibration program at all. an out-oftolerance program and procedures. international. The cost is huge in terms of lost production. document control procedures. shape. no matter the size. The question that should be asked is: “Do you have a quality calibration program that has traceable results to a national or international standard”? If the answer is yes. then it is assumed that to have a quality calibration program. So is there cost and risk? Absolutely. and reputation. or intrinsic). money. calibration records. Therefore there can be no quality in the product. time. In the case of companies that have untraceable calibration in the production of medical devices. traceability or documentation. 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. 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
3-2006. Bucher. Expression of the Uncertainty of Measurement in Calibration. EAL-G12. 3. “If you cannot measure it.”
1. Calibration Control Systems for the Biomedical and Pharmaceutical Industry. November 1995. CO. Traceability of Measurement. 1999. 2006. contaminating or damaging it under normal operating conditions • Using their work order system for requesting service when equipment is broken. Boulder. The Quality Calibration Handbook. you cannot improve it. EA-4/02. CO. NCSL. malfunctioning. 2007. or in need of calibration As Lord Kelvin was quoted as saying. Edition 1.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. Boulder. 4. ANSI/NCSL Z540. 2. Milwaukee: ASQ Quality Press.
. 5. Jay L. NCSL International. RP-6. December 1999 rev00.
. repeatability. put new and tight requirements on the accuracy of process instruments and on process control. calibrator. traceable calibration certificate.e. production processes and quality systems. which means that the calibrator used should have a valid. Does this mean that the electricians and instrumentation people should be calibration experts? Not really. i. but this topic should not be ignored. calibrator. modern calibration techniques and calibration systems have made it easier to fulfill the requirements on instrumentation calibration and maintenance in a productive way. confidence levels etc.
Calibration can briefly be described as an activity where theinstrument being tested is compared to a known reference value. such as the ISO9000 and ISO14000 series of quality standards.traceable and efficient calibrations
Traceable and efficient calibrations in the process industry
oday’s modern process plants. Fortunately. some understanding of the techniques. terminology and methods involved in calibration must be known and understood in order to perform according to International Quality Systems. call for systematic and well-documented calibrations. i. 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. with regard to accuracy. uncertainty.e. The keywords here are ‘known reference’. we must first determine what measurement is and why measuring is necessary. Quality systems. 1. However.
in general.” Therefore all instruments display false indications!
A set of experimental operations for the purpose of determining the value of a quantity. Departments House and working standards
HIERARCHY OF ACCURACY
International National standard Authorized Laboratories
Instr.” 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. Note: the true value of a quantity is an ideal concept and. it cannot be known.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.
Anyhow. they drift and lose their ability to give accurate measurements. Why calibrate
The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability.
3. the control cannot be better than the quality of measurements from the process. This conversion always involves optimizing. manpower and capital into products in the best possible way. which must be done better than the competitors. energy.
The primary reason for calibrating is based on the fact that even the best measuring instruments lack in absolute stability. Why measure?
The purpose of a process plant is to convert raw material. in other words. In practice.
EVERYTHING IS BASED ON MEASUREMENTS
PROCESS CONTROL SYSTEM
. in other words.traceable and efficient calibrations
2. optimization is done by means of process automation. regardless of how advanced the process automation system is.
type and range can show varying performance. elapsed time and type of application can all affect the stability of an instrument. Other good reasons for calibration are: • To maintain the credibility of measurements • To maintain the quality of process instruments at a good-as-new level • Safety and environmental regulations • ISO9000. This drift makes recalibration necessary. Environment conditions. other quality systems and regulations The ISO9000 and ISO14000 can assist in guiding regular. while another performs differently. systematic calibrations. which produces uniform quality and minimizes the negative impacts on the environment. elapsed time and type of application can all affect the stability of an instrument. Even instruments of the same manufacturer. One unit can be found to have good stability.
QUALITY QP C1 C2 C1–C7 CALIBRATIONS C3 C4 “GOOD AS NEW” C5 C6 C7 QM LOWER TOLERANCE
Q1 Q2 Q3
QP – PURCHASED QUALITY QZM – ZERO MAINTAINED QUALITY QM – MAINTAINED QUALITY
.traceable and efficient calibrations
they drift and lose their ability to give accurate measurements.
to ensure valid results. maintenance and storage. protected from damage and deterioration during handling. as well as the measuring devices needed to provide evidence of a product’s conformity to determined standards. Traceability
Calibrations must be traceable. the ability of computer software to satisfy the intended application is confirmed. 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. Regulatory requirements for calibration
5. adjusted or re-adjusted as necessary. the basis used for calibration or verification is recorded. In addition. identified for the determining of the calibration status.1 ISO9001: 2008 The organization determines the monitoring and measurements to be performed.traceable and efficient calibrations
4. Traceability is a declaration stating to which national standard a certain instrument has been compared. safeguarded against adjustments that would invalidate the measurement result. When used in the monitoring and measurement of specified requirements. The organization then takes appropriate action on the equipment and any product affected.
. If no such standards exist. Note: See ISO 10012 for further information. Records of the calibration and verification results are then maintained. Where necessary. This is done prior to initial use and reconfirmed as necessary. measuring equipment is calibrated or verified with measurement standards traceable to national or international standards at specified intervals.
5. the organization assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements.
. the Electronic Signature is considered equivalent to a hand-written signature. regardless of where the products are manufactured. Electronic Signatures” Software systems need features such as Electronic Signature. and Security System to be able to comply with these regulations. which add. Users must understand their responsibilities once they give an electronic signature. • A calibration period and error limits should be defined for each instrument. User Management. or delete data from an electronic record. Audit Trail. U. In such a system. Audit Trail. • Calibration records must be maintained. • Calibration standards must be more accurate than the required accuracy of the equipment being calibrated. edit.traceable and efficient calibrations
5. • All of the above should be implemented in conjunction with following regulations: – 21 CFR Part 211 – “Current Good Manufacturing Practice for Finished Pharmaceuticals” – 21 CFR Part 11 – “Electronic Records.S. • Documented change management system must be in place. all product. • Calibration standards should be traceable to national and international standards. • Calibrations must be done in accordance with written.2 PHARMACEUTICAL (FDA. • There must be documented evidence that personnel involved in the calibration process have been trained and are competent. Food and Drug Administration) Any pharmaceutical company that sells their products in the USA must comply with FDA regulations. process and safety instruments should be physically tagged. • All instrumentation should have a unique ID. User Management. approved procedures. Audit Trails should record all modifications. • All instruments used must be fit for purpose. • All electronic systems must comply with FDA’s 21 CFR Part 11.
Software systems need features such as Electronic Signature. • There should be a record of the history of each instrument. An Audit Trail is required to support change management. and Security System to be able to comply with these regulations.
Non-linearity Non-linearity is the maximum deviation of a transducer’s output from a defined straight line. Quite a few of the following terms are also used on specification sheets for calibrators. Non-linearity is specified by the Terminal Based method or the Best Fit Straight Line method. Validation Validation of measurement and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use. Please note that the definitions listed here are simplified. regardless of where the products are manufactured. Calibration An unknown measured signal is compared to a known reference signal. as described in Section 5.3 PHARMACEUTICAL (EU GMPs) Any pharmaceutical company that sells their products in the European Union must comply with EU GMPs. including Annex 11.
6. The requirements for EU GMPs are similar to those of the US FDA. DEFINITIONS OF METROLOGICAL TERMS
Some metrological terms in association with the concept of calibration are described in this section.2. Resolution Resolution is the smallest interval that can be read between two readings.traceable and efficient calibrations
Validation of measure ment and test methods (procedures) is generally necessary to prove that the methods are suitable for the intended use.
The only way to compare accuracy presented in different ways is to calculate the total error at certain points. 64
Stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. Drift is usually given as a typical value. The accuracy of the reference value is generally not included in the figures. / °C or % of RDG/ °C. Stability Often referred to as drift. It must also be checked if errors like non-linearity. hysteresis. Repeatability is often expressed in the form of standard deviation. Good resolution is required in order to detect sensitivity. under normal operating conditions. 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).S. under normal operating conditions.traceable and efficient calibrations
Sensitivity Sensitivity is the smallest variation in input. usually 90 days to 12 months. when first approaching this point with increasing values. Repeatability Repeatability is the capability of an instrument to give the same output among repeated inputs of the same value over a period of time. temperature effects etc. or % of RDG + adder.
. usually 90 days to 12 months. Accuracy is usually expressed % F. are included in the accuracy figures provided.S. Accuracy Generally accuracy figures state the closeness of a measured value to a known reference value. which can be detected as an output. stability is expressed as the change in percentage in the calibrated output of an instrument over a specified period. The difference between these two expressions is great. and then with decreasing values. Hysteresis The deviation in output at any point within the instrument’s sensing range.
If there is sufficient resolution in the measurement. Systematic errors or effects remain constant during the measurement. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty. in general. errors in calculation. Type B uncertainty Type B evaluation of uncertainty involves the use of other means to calculate uncertainty. which can vary in magnitude and in sign. It should be noted that.traceable and efficient calibrations
Uncertainty Uncertainty is an estimate of the limits. Examples of systematic effects include errors in reference value. ambient conditions. for a series of measurements under the same conditions. Type A involves the statistical analysis of a series of measurements. errors due to observer fallibility cannot be accommodated within the calculation of uncertainty.
.e. uncertainty is calculated using Type A uncertainties. in general. Standard deviation is used as a measure of the dispersion of values. The standard deviation. rather than applying statistical analysis of a series of measurements. in an unpredictable manner. set-up of the measuring. Examples of such errors include: errors in recording data. Type B. is used for calculation. at a given cover factor (or confidence level). In this case. etc. i. Values belonging to this category may be derived from:
It should be noted that. It involves the evaluation of uncertainty using scientific judgement based on all available information concerning the possible variables. The other group of components. Type B uncertainty is used when the uncertainty of a single measurement is expressed. which contain the true value. Type A uncertainty The type A method of calculation can be applied when several independent measurements have been made under the same conditions. Uncertainty is evaluated according to either a “Type A” or a “Type B” method. could be said to be of a systematic nature. there will be an observable difference in the values measured. often called the “root-mean-square repeatability error”. the effects of these components include measurement errors. or the use of inappropriate technology.
traceable and efficient calibrations
• Experience with or general knowledge of the behavior and properties of relevant materials and instruments • Ambient temperature • Humidity • Local gravity • Atmospheric pressure • Uncertainty of the calibration standard • Calibration procedures • Method used to register calibration results • Method to process calibration results The proper use of the available information calls for insight based on experience and general knowledge. In cases where normal (Gaussian) distribution can be assumed.
7. 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. k=2.g. Usually one of the following confidence levels are used: 1 s = 68% 2 s = 95% 3 s = 99%
For uncertainty specifications. The maintenance management system may alert when calibration is
. A well-based Type B evaluation of uncertainty can be as reliable as a Type A evaluation of uncertainty. there must be a clear statement of cover probability or confidence level. The expanded uncertainty corresponds to a coverage probability (or confidence level) of approximately 95%. the standard coverage factor. For uncertainty specifications. there must be a clear statement of cover probability or confidence level. should be used. especially in a measurement situation where a Type A evaluation is based only on a comparatively small number of statistically independent measurements. It is a skill that can be learnt with practice. CALIBRATION MANAGEMENT
Many companies do not pay enough attention to calibration management although it is a requirement e. in ISO9001: 2008.
If something is documented. effort and money. using automated tools can be 5 to 10 times faster compared to manual recording. If the calibration results need to be examined at a later time. All this saves an extensive amount of time and prevents the user from making mistakes. Once the job has been done. Choosing professional tools for maintaining calibration records and doing the calibrations can save a lot of 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. It automatically creates a list of instruments waiting to be calibrated in the near future. An efficient calibration management system consists of calibration management software and documenting calibrators. and the traceability chain is documented without requiring any further actions from the user.traceable and efficient calibrations
needed and then opens up a work order. 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. Depending on what process variable is calibrated and how many calibration points are recorded. Calibration records. (s)he simply downloads the instrument details from the calibration management software into the memory of a documenting calibrator. The “As Found” and “As Left” are saved in the calibrator’s memory. The increase in work productivity allows for more calibrations to be carried out within the same period of time as before. While the calibration results are uploaded onto the database. When the technician is about to calibrate an instrument. Thus the calibrator is able to detect if the calibration was passed or failed immediately after the last calibration point was recorded. finding the sheets requires a lot of effort. Modern calibration management software can be a tool that automates and simplifies calibration work at all levels. The instrument’s measurement ranges and error limits are defined in the software and also downloaded to the calibrator.
. and there is no need to write down anything with pen. Unfortunately. no printed notes. what happens between opening and closing of the work order is not documented very often. the software automatically detects the calibrator that was used. etc. the work order will close and the maintenance system will be satisfied. There is no need to make tricky calculations manually in the field. it is usually in the form of a hand-written sheet that is then archived. are needed.
modern calibrators can also read HART. be possible. temperature and electrical signals including frequency and pulses. printing them must. therefore accessing previous results is also possible in just a few seconds. When an instrument has been calibrated several times. it is possible to use a “reverse traceability report” to get a list of instruments that have been calibrated with that calibrator. 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. Today’s documenting calibrators are capable of calibrating many process signals. Good calibration tools help technicians work more efficiently and accurately. For instance the maintenance manager can use it as a calibration planning and decision-making tool for tracking and managing all calibration related activities.
instrument. and they can be even used for configuring these “smart” transmitters. It is not very uncommon to have a calibrator that calibrates pressure. are kept in the database. it does not mean the job is an enormous one. When all calibration related data is located in a single database the software is obviously able to create calibration related reports and documents. which assists in determining whether or not the calibration period should be changed. If a calibrator drifts out of its specifications. Transferring to a new calibration system may sound like a huge task and it can be a huge task. software displays the “History Trend”. If paper copies of certificates are preferred. The requested calibration records can be viewed on screen with a couple mouse clicks. If the calibration management software includes the right tools. it is possible to manage calibration records on computer without producing any papers. QA will find a calibration management system useful. Foundation Fieldbus or Profibus output of the transmitters. of course. One of today’s trends is to move towards to a paperless office.
. the users can concentrate on their primary job. In addition to the conventional mA output of a transmitter. Although there is a lot of data involved. When many tasks are automated. the system is easy to learn and use.traceable and efficient calibrations
Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. Implementing a modern calibration management system benefits everybody who has anything to do with instrumentation. If the system manufacturer has paid attention usability. When an auditor comes for a visit.
It assists in documenting. analyzing and finally optimizing the calibration work. Electronic Signatures”  21 CFR Part 211: “Current Good Manufacturing Practice for Finished Pharmaceuticals”
A good. automated calibration system reduces workload.traceable and efficient calibrations
Nowadays most companies have instrumentation data in some type of electronic format: as Excel spreadsheets. CONCLUSION
A good. 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. The vendor of the calibration system is most likely able to import most of the existing data to the calibration database saving months of work. etc. scheduling.
. References  ISO9001: 2008 “Quality Management Systems. Requirements”  21 CFR Part 11: “Electronic Records. Maintenance databases. planning.
Calibration Management and Maintenance
Why Calibrate? What is the risk of not calibrating?
alibration can be briefly described as an activity where the instrument being tested is compared to a known reference value. At the simplest level, calibration is a comparison between measurements – one of known magnitude or correctness made or set with one device, and another measurement made in as similar a way as possible with a second device. The device with the known or assigned correctness is called the standard. The second device is the unit under test or test instrument. Calibration is often required with a new instrument or when a specified time period or a specified number of operating hours has elapsed. In addition, calibration is usually carried out when an instrument has been subjected to an unexpected shock or vibration that may have put it out of its specified limits. Calibration in industrial applications When a sensor or instrument experiences temperature variations or physical stress over time, its performance will invariably begin to decline, which is known as ‘drift’. This means that measurement data from the sensor becomes unreliable and could even affect the quality of a company’s production. Although drift cannot be completely eliminated, it can be discovered and rectified via calibration. The purpose of calibration is to determine how accurate an instrument or sensor is. Although most instruments provide high accuracy these days, regulatory bodies often need to know just how inaccurate a particular instrument is and whether it drifts in and out of specified tolerance over time.
Although drift cannot be completely eliminated, it can be discovered and rectified via calibration.
Fluctuating temperatures. Product manufacturing also depends on accurate masses and so laboratories and production departments in the food and beverage. Furthermore. neglecting calibration can lead to unscheduled production or machine downtime. harsh 74
Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. However. calibration has costs associated with it and in uncertain economic times. The stability of an instrument very much depends on its application and the environment it operates in. harbors and retail outlets. oil and gas. this may even lead to a company losing its license to operate due to company not meeting its regulatory requirements.
. Determining the correct mass of a product or material is particularly important for companies that supply steel. product and process quality issues or even product recalls and rework. Weighing instruments also need to be calibrated regularly. if the instrument is critical to a process or is located in a hazardous area. an end product manufactured by a plant with poorly calibrated instruments could present a risk to both consumers and customers. also need to calibrate their weighing instruments. power. Similarly. Even the highest quality instruments will drift over time and lose their ability to provide accurate measurements. paper and pulp. Why is calibration important? Calibration ensures that instrument drift is minimized.why calibrate
The costs and risks of not calibrating Unfortunately. aviation companies. In certain situations. Invoicing in these industries is often based on process measurements. energy. This is particularly true for the food and beverage sector and for pharmaceutical manufacturers. allowing that sensor to drift over time could potentially result in a risk to employee safety. who invoice customers based on the mass of what they supply (fiscal metering). chemical and pharmaceutical industries. 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. These companies need to prove not only that the mass is accurate but also that the equipment producing the readings was correctly calibrated. It is therefore critical that all instruments are calibrated at appropriate intervals. There is therefore a growing need to have the metrological quality of these weighing instruments confirmed by calibration.
Calibration also ensures that product or batch quality remains high and consistent over time. Incorrect measurements in a hazardous area could lead to serious consequences. in addition to the BRC certificate of food safety. This affects all process manufacturers. Even instruments manufactured by the same supplier can vary in their performance over time. instrument calibration can help to optimize a company’s production process or to increase the plant’s production capacity.
The role of calibration is very important to ensure the quality and safety of the processes. Quality systems such as ISO 9001. GMP.6%. approved procedures. Typically. For example. there must be documented evidence that employees involved in the calibration process have been properly trained and competent. at the Almaraz Nuclear Power Plant in Spain. repeatability. Furthermore. energy and utilities industries. On the people side. enabled the reactor power in each unit to be increased by 1. the quality of the beer is a number one priority. by improving the measurement of reactor power parameters from 2% to 0. Safety is another important reason to calibrate instruments. He comments: “For Heineken. well-documented calibrations with respect to accuracy. process and safety instruments should also be physically tagged. Production environments are potentially high risk areas for employees and can involve high temperatures and high pressures.” Pharmaceutical manufacturers must follow current Good Manufacturing Practices. In the power generation. each instrument has a master history record and a unique ID. The role of calibration is very important to ensure the quality and safety of the processes. Standards must also be more accurate than the required accuracy of the equipment being calibrated. All product. requires that calibration records are maintained and calibrations have to be carried out in accordance with written. We must therefore ensure that all processes correspond to the planned characteristics.why calibrate
manufacturing conditions (dust and dirt) and elapsed time are all contributing factors here. uncertainty and confidence levels. with all electronic systems complying with FDA regulations 21 CFR Part 11. a calibration interval and error limits should be defined for each instrument and standards should be traceable to national and international standards. All the plants in Spain have received ISO 9001 and ISO 14001 certifications.4%. which has a significant effect on annual production capacity. ISO 9002 and ISO 14001 require systematic. The company must also have a documented change management system in place. Armando Rivero Rubalcaba is head of Instrumentation at beer producer Heineken (Spain).
gas conversion devices must be extremely accurate in measuring delivered gas. measurement specialist at Mazovian Gas Company states: “Most importantly. Proper invoicing is therefore critical to energy and utilities companies.” Neglecting to calibrate process instruments can also affect a company’s bottom line profits.why calibrate
Calibration is of great importance. Therefore. manufacturers of food and beverage or pharmaceutical products could put their customers’ lives at risk by neglecting to calibrate their process instruments. controlling emissions is another critical factor for many process manufacturers. Instrument Maintenance Engineer at Shell (Netherlands) explains: “Until recently.” Today. This means that requirements for the calibrators are especially high. for example. including sensors used for measuring CO2 and NOX emissions. Calibrating instruments can help to make combustion more efficient in industrial ovens and furnaces.7 million US dollars every year. When only large companies with revenues of more than 1 billion US dollars are considered. weighing scales or gas conversion devices. Measuring instruments that yield wrong values could easily ruin the final product. accurate measurements ensure proper billing. Similarly. The impact of even a small measurement error can be tremendous in terms of lost revenue. especially from the viewpoint of production safety and quality of the final product. poor quality calibration is on average costing manufacturers more than 1. Customers want to pay for the exact amount of gas they’ve received. As Ed de Jong. The latest Government regulations relating to carbon emissions may also require that companies calibrate specific instruments on a regular basis. 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. this figure rises dramatically to more than 4 million US dollars per year. 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
. according to recent research by Nielsen Research/ ATS Studies. As he puts it: “Calibration is of great importance. Preparation of the right rubber mixture is precision work and a sample is taken from each rubber mixture to ensure quality. especially from the viewpoint of production safety and quality of the final product. Indeed. Heikki Karhe is a measurement technician at the tyre manufacturer Nokian Tyres. petrochemicals and chemicals sectors. As Jacek Midera. This is particularly true if sales invoicing is based on accurate process measurements.
particularly in the oil and gas.
By calibrating an instrument before installation. highly stable sensors are not calibrated as often as those sensors that are more susceptible to drift. all instruments require calibrating at set intervals. Another common misunderstanding is that new instruments do not require calibration. instruments related to CO2 and NOX emissions. some manufacturers claim that they do not need to calibrate their fieldbus instruments because they are digital and so are always accurate and correct. this does not eliminate the need for calibration. This interval may be decreased if the instrument is being used in a critical process or application. Just because a sensor is newly installed does not mean that it will perform within the required specifications. calibration has an important role especially for the license to operate.
. This is simply not true. Government regulations demand that specific instruments must be calibrated. In this way. Again. as well as begin to monitor the stability or drift of the instrument over time. How often they are calibrated depends on a number of factors. 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. When to calibrate Due to drift. For example. Although fieldbus transmitters have been improved in terms of their measurement accuracy when compared to analogue transmitters. First. The main difference between fieldbus and conventional transmitters is that the output signal is a fully digital fieldbus signal. for example.why calibrate
involved for both customers and governments [fiscal metering].
The most effective method of determining when an instrument requires calibrating is to use some sort of history trend analysis. the manufacturer of the instrument will provide a recommended calibration interval. Quality standards may also dictate how often a pressure or temperature sensor needs calibrating. a company is able to enter all the necessary instrument data to its calibration database or calibration management software. Changing the output signal does not change the need for periodic calibration.” Common misconceptions There are some common misconceptions when it comes to instrument calibration. Nowadays. this is not true.
Once this has been agreed. pressure transducers and weighing instruments – require regular calibration to ensure they are performing and measuring to specified tolerances. Careful planning and decision-making is important. Calibration software is one such tool that can be used to support and guide calibration management activities. These methods differ greatly in terms of cost. Finally. execution. efficiency. But in order to understand how software can help process plants better manage their instrument calibrations. followed by the selection of suitable calibration methods and tools for execution of these methods.
Calibration software is one such tool that can be used to support and guide calibration management activities. quality. organisation. with documentation being a critical part of this. However. it is important to consider the typical calibration management tasks that companies have to undertake. There are five main areas here. then classified into ‘critical’ and ‘non-critical’ devices. and accuracy of data and their level of automation. documentation. All plant instruments and measurement devices need to be listed. the company must identify current calibration status for every instrument across the plant. different companies from a diverse range of industry sectors use very different methods of managing these calibrations.why use software for calibration management
Why use software for calibration management?
very manufacturing plant has some sort of system in place for managing instrument calibration operations and data. with documentation being a critical part of this. and analysis. the calibration range and required tolerances need to be identified. Plant instrumentation devices such as temperature sensors. comprising of planning and decision-making. Decisions then need to be made regarding the calibration interval for each instrument.
. The creation and approval of standard operating procedures (SOPs) for each device is then required.
This paperwork typically involves preparing calibration instructions to help field engineers. organisation. a sensor drifts out of its specification range. The execution stage involves supervising the assigned calibration tasks. process and quality engineers and managers – in using the chosen tools and how to follow the approved SOPs. The effectiveness of calibration needs to be reviewed and calibration intervals checked. Staff carrying out these activities must follow the appropriate instructions before calibrating the device. making notes of calibration results in the field. Based on the calibration results. then classified into ‘critical’ and ‘non-critical’ devices. the consequences could be disastrous for the plant. a safety problem or leading to batches of inferior quality goods being produced. Documentation Documentation is a very important part of a calibration management process. including any associated safety procedures. companies then have to analyse the data to see if any corrective action needs to be taken. 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!
. If. for example. Resources then have to be organised and assigned to actually carry out the scheduled calibration tasks. although further instructions may need to be followed after calibration.
The next stage. which may then have to be scrapped.why use software for calibration management
All plant instruments and measurement devices need to be listed. and documenting and archiving calibration data. calibration labels need to be created and pasted. approved procedures. service engineers. The documentation and storage of calibration results typically involves signing and approving all calibration records that are generated. involves training the company’s calibration staff – typically maintenance technicians. ISO 9001:2008 and the FDA both state that calibration records must be maintained and that calibration must be carried out according to written. The next calibration tasks then have to be scheduled. These intervals may need to be adjusted based on archived calibration history. The calibration is then executed according to the plan. 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. resulting in costly production downtime. then created documents copied and archived.
Noting down calibration results by hand in the field and then transferring these results into a spreadsheet back at the office may seem archaic. different industry sectors have different requirements and regulations. many of these firms said they were doing it without any sort of calibration software to assist them. where 21 per cent of firms said they calibrated their instruments more than 2. analysis of paper-based systems and spreadsheets can be almost impossible. for example. In the highly regulated pharmaceuticals sector. Only a quarter of companies use calibration software In Beamex’s own Calibration Study carried out recently. let alone time consuming. However. 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. The percentage is still quite high in the food & beverage sector. just under a third of companies (with 500+ employees) typically have more than 5.000 instruments that require calibrating.000 times every year. Furthermore. 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. 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.000 calibrations each year. Oil.
. However. Many other companies said that they relied on generic spreadsheets and/or databases for this. The figures outlined appear to suggest that companies really do require some sort of software tool to help them manage their instrument calibration processes and all associated documentation. A significant proportion (almost 20 per cent) of those surveyed said they used a manual. the picture in reality can be very different. In a recent survey conducted by Control Magazine. In the Power & Energy sector.why use software for calibration management
When it comes to the volume of documentation required. a massive 75 per cent of companies carry out more than 2. Gas & Petrochemicals is similarly high. paper-based system. This equates to a huge amount of paperwork for any process plant.000 calibrations per year. but many firms still do this. with 55 per cent of companies performing more than 2. Any type of paper-based calibration system will be prone to human error.000 calibrations each year. whilst others used a calibration module within an existing Computerised Maintenance Management System (CMMS).
Regardless of industry sector.why use software for calibration management
Using software for calibration management enables faster. for improved safety. Plants can therefore reduce costs and optimise calibration intervals by reducing calibration frequency when this is possible. this might include engineers using pens and paper to record calibration results while out in the field. On returning to the office. these notes are then tidied up or transferred to another paper document. or by increasing the frequency where necessary. every instrument calibration has to be documented and these documents need to be easily accessible for audit purposes. Just as important. or they used a uniform interval across the plant for all instruments. Typically. Using software for calibration management enables faster. Rather than rely on the manufacturer’s recommendation for calibration intervals. the company may be able to decrease the frequency of calibration. after which they are archived as paper documents. easier and more accurate analysis of calibration records and identifying historical trends.
instrument calibration intervals based on either the manufacturer’s own recommendation. Furthermore. While using a manual. paper-based system requires little or no
. The number of instruments and the total number of periodic calibrations that these devices require can be several thousand per year. potentially explosive area of the manufacturing plant. Paper-based systems These systems typically involve hand-written documents. a process plant may find it necessary to increase the frequency of some sensors that are located in a hazardous. easier and more accurate analysis of calibration records and identifying historical trends. How to plan and keep track of each instrument’s calibration procedures means that planning and scheduling is important. by analysing the calibration history of a flow meter that is located in a ‘non-critical’ area of the plant. there seems to be some general challenges that companies face when it comes to calibration management. Instrument ‘drift’ can be monitored closely over a period of time and then decisions taken confidently with respect to amending the calibration interval. Neither method is ideal in practice. Companies could save so much time and reduce costs by using calibration management software to analyse historical trends and calibration results. saving time and resources. For example. the plant may be able to extend these intervals by looking closely at historical trends provided by calibration management software.
This includes the planning and scheduling of calibration work. the calibration data is not easily accessible. FDA) for managing calibration records. the calibration process itself cannot be automated. the CMM system may not meet the regulatory requirements (e. In these systems. In-house legacy systems (spreadsheets. CMM systems are not designed to manage calibrations and so often only provide the minimum calibration functionality. soaks up a lot of resources and typing errors are commonplace. but the calibration cannot be automated because the system is not able to communicate with ‘smart’ calibrators. databases. communication with smart calibrators. Dual effort and re-keying of calibration data are also significant costs here. certificates and labels. Although instrument data can be stored and managed efficiently in the plant’s database. but the recording of calibration information is still time-consuming and typing errors are common. production of reports.why use software for calibration management
investment. the level of automation is still low. For example.
.) Although certainly a step in the right direction. automatic alarms cannot be set up on instruments that are due for calibration. Also. In addition. it is very labour-intensive and means that historical trend analysis becomes very difficult to carry out. Calibration software With specialist calibration management software. Plant hierarchy and works orders can be stored in the CMM system. calibration data is typically entered manually into a spreadsheet or database. The software manages and stores all instrument and calibration data. etc. using an in-house legacy system to manage calibrations has its drawbacks. In addition. there seems to be some general challenges that companies face when it comes to calibration management. such as the scheduling of tasks and entry of calibration results.g. analysis and optimisation of calibration frequency. and
Regardless of industry sector. The system is time consuming. The data is stored in electronic format. 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. Furthermore. users are provided with an easy-to-use Windows Explorer-like interface.
The software generates reports automatically and all calibration data is stored in one database rather than multiple disparate systems. when a plant is being audited. Documentation is also improved. complies with FDA requirements. Using software-based calibration management systems in conjunction with documenting calibrators means that calibration results can be stored in the calibrator’s memory. The system no longer requires pens and paper.
Using software for calibration management enables faster. then automatically uploaded back to the calibration software. Locating records and verifying that the system works is effortless when compared to traditional calibration record keeping. Human error is minimised and engineers are freed up to perform more strategic analysis or other important activities.
. Calibration instructions are created using the software to guide engineers through the calibration process. Calibration certificates. Benefits of using calibration software With software-based calibration management. planning and decisionmaking are improved.why use software for calibration management
easy integration with CMM systems such as SAP and Maximo. Position. These instructions can also be downloaded to a technician’s handheld documenting calibrator while they are in the field. such as Change Management. Calibration software has many functions that help in meeting these requirements. while automatic alerts for scheduled calibrations can be set up. calibration software can facilitate both the preparation and the audit itself. Analysis becomes easier too. Regulatory organisations and standards such as FDA and ISO place demanding requirements on the recording of calibration data. easier and more accurate analysis of calibration records and identifying historical trends. Audit Trail and Electronic Signature functions. There is no re-keying of calibration results from a notebook to a database or spreadsheet. The result is a streamlined. Execution is more efficient and errors are eliminated. which improves quality. device and calibrator databases are maintained. reports and labels can all be printed out on paper or sent in electronic format. for example. Organisation also improves. plant productivity and efficiency. Procedures and calibration strategies can be planned and all calibration assets managed by the software. The Change Management feature in Beamex’s CMX software. Also. enabling engineers to optimise calibration intervals using the software’s History Trend function. automated calibration process.
Even if a plant has already implemented a CMM system. Here. Manual procedures are replaced with automated. is suitable for process manufacturers with multiple global sites. calibration management software can be easily integrated to this system. support and upgrades? • Does the calibration software need to be scalable? • Can data be imported to the software from the plant’s current systems? • Does the software offer regulatory compliance? • Supplier’s references and experience as a software developer?
. those instruments that perform better than expected may well justify a reduction in their calibration frequency. If the plant instruments are already defined on a database. implementation. For example. reduce costs and increase productivity by preventing unnecessary double effort and re-keying of works orders in multiple systems. Plant efficiencies should also improve. Engineers can analyse calibration results to see whether the calibration intervals on plant instruments can be altered. These savings come from the now-paperless calibration process. multilingual users and a very large amount of instruments that require calibration. CMX Enterprise. the calibration management software can utilise the records available in the CMM system database. validated processes. only a few instruments require calibrating and where regulatory compliance is minimal. Benefits for all process plants Beamex’s suite of calibration management software can benefit all sizes of process plant. The integration will save time. Costly production downtime will also be reduced. implementing software-based calibration management means overall costs will be reduced. a central calibration management database is often implemented that is used by multiple plants across the world. which simply is not possible with a standalone CMM system.
Choosing the right calibration software • Is it easy to use? • What are the specific requirements in terms of functionality? • Are there any IT requirements or restrictions for choosing the software? • Does the calibration software need to be integrated with the plant’s existing systems? • Is communication with smart calibrators a requirement? • Does the supplier offer training. with no manual documentation procedures. For medium-to-large sized companies that have multiple users who have to deal with a large amount of instruments and calibration work. as well as strict regulatory compliance. which is particularly beneficial if the company is replacing a lot of labour-intensive calibration activities. For relatively small plants.Business benefits For the business. Beamex CMX Light is the most appropriate software. Integration also enables the plant to automate its calibration management with smart calibrators. as the entire calibration process is now streamlined and automated. Beamex CMX Professional is ideal. Beamex’s high-end solution. where calibration data is needed for only one location.
across all industry sectors. Compared to traditional. increased productivity and reduced costs of the entire calibration process. Despite these benefits. using dedicated calibration management software results in improved quality. Summary Every type of process plant. paper-based systems. whilst 92% said that using CMX had improved the quality of their calibration system. in-house built legacy calibration systems or calibration modules with CMM systems.why use software for calibration management
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. 94% of CMX users stated that using Beamex products had improved the efficiency of their calibration processes. only one quarter of companies who need to manage instrument calibrations actually use software designed for that purpose. regardless of industry sector. 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. can benefit from implementing specialist calibration management software.
The business benefits of using software for calibration management • Cost reduction • Quality improvements • Increase in efficiency
safety issues or possibly leading to batches of inferior quality goods being produced. By doing it. If sensors drift out of their specification range. the consequences can be disastrous for a plant. 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
lants can improve their efficiency and reduce costs by performing calibration history trend analysis. resulting in costly production downtime. Most process manufacturing plants will have some sort of maintenance plan or schedule in place. Calibration history trend analysis is only possible with calibration software that provides this functionality. pressure transducers. but for other sensors that are deemed less critical to production. Adjusting calibration intervals based on history trend analysis Manufacturing plants need to be absolutely confident that their instrumentation products – temperature sensors. which ensures that all instruments used across the site are calibrated at the appropriate times. which then have to be scrapped. This can sometimes lead to instruments being prioritised for calibration. with increasing demands and cost issues being placed on manufacturers these days. the time and resources required to carry out these calibration checks are often scarce.
. a function available within Beamex® CMX calibration software. flow meters and the like – are performing and measuring to specified tolerances. However. being calibrated less frequently or not at all. with those deemed critical enough receiving the required regular checks.
paper and pulp. Interestingly. 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. ensuring that instruments are checked and corrected before they drift out of tolerance. the survey showed that from all industry sectors. Cost savings can be achieved in several ways. due to it being a highly regulated industry. Perhaps unsurprisingly. Current practices in process plants But in reality. chemicals. in the pharmaceuticals sector. how often do process plants actually calibrate their instruments and how does a maintenance manager or engineer know how often to calibrate a particular sensor? In March 2010. First. power and energy. is only possible with calibration software that provides this type of functionality. drifts in and out of tolerance over a given time period. a function available within Beamex® CMX calibration software. these plants also calibrate their instruments more frequently than other industry sectors. the study proved also that the pharmaceuticals sector typically possesses a significantly higher number of instruments per plant that require calibrating. service. the plant can analyze whether it should increase or decrease the calibration frequency for all its instruments. by calibrating instruments more often when they are located in critical areas of the plant. However. by calibrating less frequently where instruments appear to be highly stable according to their calibration history. With this function. In addition. 56% of the respondents said they calibrated their instruments no more than once a year. food and beverage.
.how often should instruments be calibrated
Sensors that are found to be highly stable do not need to be re-calibrated as often as sensors that tend to drift.
But plants can improve their efficiencies and reduce costs by using calibration ‘history trend analysis’. The survey covered all industry sectors. for example. The analyses of historical trends and how a pressure sensor. Second. This type of practise is common in companies that employ an effective ‘Preventive Maintenance’ regime. oil and gas. including pharmaceuticals. 59% said they calibrated once a year and 30% said they calibrated twice a year. manufacturing.
Doing this. With CMX’s History Trend Option. the engineer now has data to present to the supplier to support his findings. weeks. But there are other. can use the functionality to compare different sensor types to see which one best suits the new process. perhaps less obvious benefits of looking at the historical drift over time of a particular sensor or set of measuring instruments. Sensors that are found to be highly stable do not need to be re-calibrated as often as sensors that tend to drift. If it hasn’t. actually performed within the specified tolerance over a certain time period. he says. The History Trend function also means that a plant can now compare the quality or performance of different sensors from multiple manufacturers in a given location or set of process conditions. without doubt. He specialises in selling the Beamex® CMX to different customers across all industry sectors. or even years of operation and which can be left for longer periods. therefore eliminating unnecessary calibration effort and time. is determining which sensors should be recalibrated after a few days.
. He comments: “The largest savings from using the History Trend Option are in the pharmaceuticals sector.
The function enables users to plan the optimal calibration intervals for their instruments.how often should instruments be calibrated
The benefits of analyzing calibration history trends But regardless of the industry sector. by analysing an instrument’s drift over time (ie. Calibration schedules take into account the accuracy required for a particular sensor and the length of time during which it has previously been able to maintain that degree of accuracy. This makes it an invaluable tool for maintenance or quality personnel who. Pertti Mäki is Area Sales Manager at Beamex. Calibration software such as CMX can also help with the planning of calibration operations. the supplier provides a technical specification that includes details on what the maximum drift of that sensor should be over a given time period. in setting up a new process line for example.” But that’s not all. the engineer can now verify that the sensor he or she has purchased. but all industry sectors can benefit from using the software tool.” The trick. the historical trend) companies can reduce costs and improve their efficiencies. enables maintenance staff to concentrate their efforts only where they are needed. which helps companies identify the optimal calibration intervals for instruments. says Mäki. without of course sacrificing the quality of the product or process or the safety of the plant and its employees. As Mäki explains: “When an engineer buys a particular sensor.
it is then possible to make decisions and conclusions regarding the optimal calibration interval and the quality of the instruments with respect to measurement performance. The ‘History Trend’ window enables users to view key figures of several calibration events simultaneously. allowing to evaluate the calibrations of a position or a device for a longer time period compared to the normal calibration result view.how often should instruments be calibrated
History Trend displays the instrument’s drift over a given period both numerically and graphically. for example.
The History Trend function enables users to plan the optimal calibration intervals for their instruments. the engineer can analyze how different devices are suited for use in a particular area of the plant or process. Also. Based on this information. For example. Reporting is straightforward and the user can even tailor the reports to suit his or her individual needs. Once implemented. maintenance personnel. using the ‘Report Design’ tool option. History Trend displays the instrument’s drift over a given period both numerically and graphically.
. the user can get an overview of how a particular device drifts between calibrations and also whether the drift increases with time. can analyze an instrument’s drift over a certain time period.
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 history trend is made automatically without any extra manual work.
. • The graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments.
HISTORY TREND REPORT
HISTORY TREND USER-INTERFACE
The graphical display of the history trend helps in visualizing and optimizing the calibration interval for the instruments. • The Beamex® CMX stores every calibration event into the database. This helps in comparing differences between devices.
how often should instruments be calibrated
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. 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. 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
d) be safeguarded from adjustments that would invalidate the measurement result. b) be adjusted or re-adjusted as necessary.6 Control of monitoring and measuring devices The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.4). against measurement standards traceable to international or national measurement standards.how often should instruments be calibrated
ISO 9001:2008 quality management requirements
7. maintenance and storage. e) be protected from damage and deterioration during handling. c) be identified to enable the calibration status to be determined. the ability of computer software to satisfy the intended application shall be confirmed. the basis used for calibration or verification shall be recorded.
. In addition. the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. This shall be undertaken prior to initial use and reconfirmed as necessary.2. Where necessary to ensure valid results. or prior to use. 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. where no such standards exist. measuring equipment shall a) be calibrated or verified at specified intervals. When used in the monitoring and measurement of specified requirements. Records of the results of calibration and verification shall be maintained (see 4.
how often should calibrators be calibrated
How often should calibrators be calibrated
s a general rule for Beamex’s documenting MC calibrators, starting with a 1-year calibration period is recommended, because the calibrators has a 1-year uncertainty specified. The calibration period can be changed in the future, once you begin receiving cumulated stability history, which is then compared to the uncertainty requirements. In any case, there are many issues to be considered when deciding a calibrator’s calibration period, or the calibration period for any type of measuring device. This article discusses some of the things to be considered when determining the calibration period, and provides some general guidelines for making this decision. The guidelines that apply to a calibrator, also apply to other measuring equipment in the traceability chain. These guidelines can also be used for process instrumentation. An important aspect to consider when maintaining a traceable calibration system is to determine how often the calibration equipment should be recalibrated. International standards (such as ISO9000, ISO10012, ISO17025, CFRs by FDA, GMP, etc.) require the use of documented calibration programs. This means that measuring equipment should be calibrated traceably at appropriate intervals and that the basis for the calibration intervals should be evaluated and documented. When determining an appropriate calibration period for any measuring equipment, there are several things to be considered. They are discussed below.
Uncertainty need is one of the most important things to consider when determining the calibration period.
how often should calibrators be calibrated
Uncertainty need One of the first things to evaluate is the uncertainty need of the customer for their particular measurement device. Actually, the initial selection of the measurement device should be also done based on this evaluation. Uncertainty need is one of the most important things to consider when determining the calibration period. Stability history
In critical applications, the costs of an outof-tolerance situation can be extremely high (e.g. pharmaceutical applications) and therefore calibrating the equipment more often is safer.
When the customer has evaluated his/her needs and purchased suitable measuring equipment, (s)he should monitor the stability history of the measuring equipment. The stability history is important criteria when deciding upon any changes in the calibration period. Comparing the stability history of measuring equipment to the specified limits and uncertainty needs provides a feasible tool for evaluating the calibration period. Naturally, calibration management software with the history analysis option is a great help in making this type of analysis. The cost of recalibration vs. consequences of an out-of-tolerance situation Optimizing between recalibration costs and the consequences of an outof-tolerance situation is important. In critical applications, the costs of an out-of-tolerance situation can be extremely high (e.g. pharmaceutical applications) and therefore calibrating the equipment more often is safer. However, in some non-critical applications, where the out-oftolerance consequences are not serious, calibration can be made less frequently. Therefore, evaluating of the consequences of an out-oftolerance situation is something to be considered. The corrective actions in such a case should also be made into an operating procedure. Some measurements in a factory typically have more effect on a product quality than others, and therefore some measurements are more acute than others and should be also calibrated more often than others. Initial calibration period When you purchase calibration equipment with which you are not familiar, you still need to decide the initial calibration period. In this
how often should calibrators be calibrated
situation, abiding by the manufacturer’s recommendation is best. For more acute applications, using a shorter calibration period right from the beginning is recommended. Other things to be considered There are also other issues to be considered when determining the calibration period, such as the workload of the equipment, the conditions where the equipment will be used, the amount of transportation and is the equipment look damaged. In some cases, crosschecking with other similar measuring equipment is also feasible for detecting the need for calibration. Crosschecking may be carried out before every measurement in some acute applications. Naturally, only appropriate, metrological, responsible personnel in the company may make changes to the calibration equipment’s calibration period.
In some cases, crosschecking with other similar measuring equipment is also feasible for detecting the need for calibration.
The main issues to be considered when determining the calibration period for measuring equipment should include at least following: • The uncertainty needs of the measurements to be done. • The stability history of the measuring equipment. • Equipment manufacturer’s recommendations. • The risk and consequences of an out-of-tolerance situation. • Acuteness of the measurements.
com). amongst the process manufacturing industries. magazines. Globally. calibrating instruments is an enormous task that consumes vast amounts of paperwork. which means they are missing out on the benefits of moving towards a paperless calibration system. Take a minute to look around the room you are in and you’ll notice how many objects are made from paper: books. Global consumption of paper has grown 400% in the last 40 years. a paper-based calibration system involves the use of handwritten documents. there are other. Whilst out in the field. significant benefits in minimising the use of paper. Other than helping to save our planet and reducing the number of trees cut down each year. Far too many of these companies still use paper-based calibration systems. Traditional paper-based calibration systems Typically. 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. ecology. especially given that there are technologies. printer paper. a maintenance or service
Far too many of these companies still use paper-based calibration systems. Take the calibration of plant instrumentation devices such as temperature sensors. our consumption of paper is far higher than it needs to be. software and electronic devices readily available today which render the use of paper in the workplace unnecessary. weighing instruments and pressure transducers.
. as businesses. As manufacturing companies. So let’s not add to this already heavy burden on our forests and the environment. which means they are missing out on the benefits of moving towards a paperless calibration system. Today.paperless calibration improves quality and cuts costs
Paperless calibration improves quality and cuts costs
aper is part of our everyday lives – whether in the workplace or at home. perhaps even a poster on the wall.
These same companies that use paper-based calibration systems are together generating hundreds of thousands (millions?) of paper calibration certificates each year. when these records can all be combined into a single electronic record? Improved workflow With paper-based systems. workflow improves dramatically. as those individuals who need to sign off records or calibration
. There will be less waiting time. Practical benefits of using less paper Aside from the financial benefits of moving towards a paperless calibration system. important paper records could potentially be lost or damaged in an accident or fire. Often. it is not practicable to store or carry lots of paperwork. accessing calibration data quickly is not easy. paper-based system requires little or no investment in new technology or IT systems. With paperless systems. etc. After all. after which they are archived as paper documents. standard operating procedures (SOPs). In addition. whilst also improving quality. workflow and making other significant cost savings for the business. So why would these companies generate and store separate paper copies of important records such as works orders. which is time-consuming. paper records that need approval have to be routed to several individuals. in industrial environments. On returning to the office. by utilising the latest software-based calibration management systems from companies like Beamex. there are practical reasons why firms should go paperless. these organisations can significantly reduce their paper consumption. Dual effort and the re-keying of calibration data into multiple databases become significant costs to the business. it is extremely labourintensive and means that historical trend analysis of calibration results becomes very difficult. these notes are then tidied up and/or transferred to another paper document. every square foot of the business has an associated cost. Paper systems are time consuming.
engineer will typically use a pen and paper to record instrument calibration results. Furthermore. blank calibration certificates. they soak up lots of company resources and manual (typing) errors are commonplace. However. workflow improves dramatically. While using a manual.paperless calibration improves quality and cuts costs
With paperless systems.
Business benefits For those more enlightened companies that use software-based calibration systems. engineers and management will have more confidence in
Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. For example.paperless calibration improves quality and cuts costs
documents can share or access electronic records simultaneously from a central database. Illegible handwritten notes are also a problem. The whole calibration process – from initial recording of calibration data through to historical trend analysis – will take less time. the business benefits are significant. as well as the cost of filing and storing those paper records. 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. manual errors such as misreadings can occur. faster and more reliable. Historical trending becomes easier.
. those instruments that are performing better than expected may well justify a reduction in their calibration frequency. calibration software facilitates both the preparation and the audit itself. Sometimes users may inappropriately modify the results data due to work pressures or lack of time/resources. Locating records and verifying that the system works becomes effortless when compared to traditional paper-based record keeping. Calibration intervals can be optimised. The cost and time associated with printing copies of paper documents is also eliminated. this means that operators. electronic records enable easier analysis of data. In turn. When a plant is being audited. whilst mistakes and manual errors will be virtually eliminated. Paper records may not always reflect the truth. Just as important. especially if these paper records need to be typed or transcribed to a computer system or database. which again has cost reduction benefits to the business. Paperless calibration systems improve plant efficiencies because the entire calibration process is now streamlined and automated. For example. 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. particularly when using weighscales or other instruments that are open to an individual’s own interpretation of the data. particularly calibration results.
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. end-to-end workflows. resulting in completely paperless. 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. resulting in completely paperless. Although handover by commissioning teams that use paper records is straightforward and of universal format. without needing to collect all the plant data again. The un-editable electronic data stored on high performance multifunction calibrators can be uploaded to calibration management software for safe storage and asset management. Electronic data also provides an excellent foundation for ongoing plant operation and maintenance. In other words. data historians.paperless calibration improves quality and cuts costs
the data. How paperless should you go? Of course. end-to-end workflows. Companies can go even further than this and use electronic records for works orders.
The calibration data is shared with other business IT systems electronically. technician friendly interfaces on industrialized PDA or tablet based hardware when manual data entry cannot be avoided. particularly when it comes to plant audits. electronic records simplify the handover of plant and equipment. business management systems. in reality.
. 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 addition. many companies are neither completely paperless nor rely solely on paper-based systems – the process is sometimes a hybrid of the two. electronic records are easy to manipulate and can be re-used in different IT systems. often in difficult industrial environments that would make the use of portable office computers impractical. increased efficiencies and reduced plant downtime. A key part of paperless calibration records is the capture of data at point of work. the calibration data is shared with other business IT systems electronically. and for control systems. Commissioning At plant commissioning times.
paper-based systems. Here. as well as the sensors that monitor the incoming chemical additives and the outgoing effluent. Case study Beamex is helping many organisations to implement paperless calibration management systems. Each vessel needs to be certified at least once every two years in order to demonstrate that the vessel is safe and structurally sound. Amongst these customers is UK firm Croda Chemicals Europe. This includes a functionality check on all of the pressure instrumentation. which may be used to dealing with traditional.” Today. Power & Energy. which may be used to dealing with traditional. Based in East Yorkshire near Goole. paper-based systems.
. easier and more accurate than our old paper-based procedures. Chemicals. training & education Paperless systems also need validating in the user’s own environment. as this will help companies to overcome the natural resistance to change amongst the workforce.”
Education and training for users is critical. “It’s faster. 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. education and training services for customers. “It’s saving us around 80 manhours per maintenance period and should pay for itself in less than three years. Validation.” says Wright. Oil Gas & Petrochemicals companies. Croda uses the CMX calibration management software system from Beamex. the Croda plant uses pressurised vessels to purify lanolin for healthcare and beauty products. which coordinates data collection tasks and archives the results. it is better to source the data electronically using documenting calibrators that are specifically designed for this task. Beamex provides comprehensive validation.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. including Pharmaceuticals. Education and training for users is critical. as this will help companies to overcome the natural resistance to change amongst the workforce.
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. calibration of instrumentation. testing of the control systems as well as verification of the operation of all interlocks and other safety systems are also typical commissioning tasks. These activities are usually described as ‘cold commissioning’. is ready for commissioning when the plant has achieved mechanical completion. In general. Pre-commissioning activities are those which have to be undertaken
. or any defined part of a plant.intelligent commissioning
alibration plays a vital role in process plant commissioning and when installing new instruments. the plant will be fully ready for production operation. 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.
Successful commissioning of process instrumentation is an essential requirement for ideal plant performance. What is process instrument commissioning?
Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. A plant. At the completion of commissioning. Commissioning may involve mock operations which are commissioning activities conducted to allow operational testing of the equipment and operator training and familiarization. This article explains process instrument commissioning and the benefits of calibration during the commissioning phase. operational testing of plant equipment. Energizing power systems.
Commissioning requires a team of people with a background in plant design. it may cost more.
prior to operating equipment. This can prove to be a worthwhile investment for large plants because it allows for dedicated responsibility and focus in operations and significant improvements to schedules. in fact. connecting to and identifying the field device. It is essential to comprehend the scope and length of commissioning activities and include them in the initial project plan and budget allocations. and ensure this commitment is maintained. because the funds have been allotted to cover budget overruns. there is a risk that the work may be under-resourced. as the plant owner’s commitments in terms of product marketing and operational costs are likely to be higher. 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. personnel and cost of commissioning Since commissioning takes place toward the end of the project. Each of the commissioning activities must be broken down into a number of manageable tasks. and adverse incidents at the start-up phase can be avoided. 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. physically installing the field device. As there are many cost factors in the commissioning process. The rate
. these steps must be repeated with every field device that will be installed at the plant. Some companies employ specialized commissioning engineers. plant operation and plant maintenance. Management.intelligent commissioning
There are many reasons why instruments should be calibrated during the commissioning phase before start-up. detailed planning of commissioning and plant handover are essential elements of the overall project plan and schedule as any other grouping of activities. The cost of process instrument commissioning is typically affected by the following issues: learning and familiarizing with the field device. An extra day taken for commissioning means the same to the plant owner as an extra day taken during designing or construction. and a schedule needs to be established for each task including benchmarks for monitoring purposes. configuring the required parameters and testing the configuration and interface to other systems. and the re-commissioning activities have been completed to the extent where the owner approves the plant and can begin commissioning activities. Basically.
Sequence of activities leading to commissioning and acceptance of a plant. thereby enabling progress to be reviewed regularly. instruments are often recalibrated upon arrival at the site. Calibration and the commissioning of field instrumentation New process instrumentation is typically configured and calibrated by the manufacturer prior to installation. teamwork and training are all essential. Successful commissioning of process instrumentation must be considered within the context of the overall commissioning program. However. and the size of the team and composition of specialists depends on the nature and scope of the system. Good planning. such as the Beamex® CMX Calibration Software. especially if there has been obvious
. number of loops or sequence of steps tested per day). communications. instrument and process engineers.
of commissioning is measurable (e.g. The commissioning team consists of a mixture of specialists.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. coordination. documentation.
specified settings.intelligent commissioning
damage in transit or storage. The trick is determining which sensors should be recalibrated after a few hours. Monitoring the quality and stability of a transmitter When calibration procedures are performed for an uninstalled instrument. Calibrating a new instrument before installing or using it is a quality assurance task. There are also many other reasons why instruments should be calibrated during the commissioning phase before start-up. it is possible to monitor the stability of the transmitter. it is possible that the original planned settings are not valid anymore and they need to be changed. 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. the calibration serves also future purposes. such as the Beamex® CMX Calibration Software. By calibrating an instrument you can check the settings of the instrument.
The new uninstalled instrument or transmitter may have the correct. 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. when the initial planned specifications have been changed. or years of operation and which can be left as is for
. weeks. specified settings. Transmitters that are found to be highly stable need not be recalibrated as often as transmitters that tend to drift. By calibrating the transmitter before installation and on a regular basis thereafter. Assuring transmitter quality First of all. The calibration database can be calibration software designed specifically for managing calibration assets and information. as was explained in the previous paragraph. After you have performed this task. it is possible to reconfigure the transmitter. However. Reconfiguring a transmitter
The trick is determining which sensors should be recalibrated after a few hours. weeks. Calibration is therefore a key element in the process of reconfiguring an uninstalled transmitter. the fact that an instrument or transmitter is new does not automatically mean that it is within required specifications. or years of operation and which can be left as is for longer periods without sacrificing quality or safety. The transmitter information is critical in defining the quality of the instrument and for planning the optimal calibration interval of the instrument.
Foundation Fieldbus and Profibus. Doing so allows maintenance personnel to concentrate their efforts only where needed. productivity and cost-effectiveness of a plant’s 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. 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. which mean that they can be used to replace several individual measurement devices. consisting of calibration software and documenting calibration equipment. does anyone perform the calibration (check in/out function) and what is the instrument/position status (pass/fail). The Beamex® CMX can be used for planning and scheduling calibrations. HART. The Beamex® MC series documenting calibrators can be used for calibrating pressure. smarter and more accurate management of all calibration assets and procedures. for instance. Intrinsically safe calibrators for potentially explosive environments are also available. electrical and frequency signals. making the entire process much quicker and reducing costs. By using a documenting calibrator. such as analog.
. improves the quality and efficiency of the entire calibration system through faster. Therefore. Engineers performing calibrations no longer have to write down any results on paper. Integrated calibration solution by Beamex The Beamex® Integrated Calibration Solution. Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important.intelligent commissioning
longer periods without sacrificing quality or safety. thereby eliminating unnecessary calibration work. The Beamex calibrators are all-in-one calibrators. overlooked or become overdue. Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks do not get forgotten. temperature. are they installed and ready for calibration. overlooked or become overdue. Using the CMX gives always a clear status of the transmitters. the calibration results are stored automatically in the calibrator’s memory during the calibration process. The Beamex calibrators support various different transmitter protocols. managing and storing all calibration data as well as analyzing and optimizing the calibration interval. The Beamex® CMX Calibration Software can be used for improving the quality.
The quality and accuracy of calibration results also improve. saving time and money. as there are fewer mistakes due to human error. again. 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.
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.
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
. the calibration results are stored automatically in the calibrator’s memory during the calibration process. This means that engineers do not spend their time transferring the results from their notepad to final storage on a computer. instead of typing the data manually into the calibration database.
but critical part of a company’s asset management strategy should be the calibration of process instrumentation. a small. 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. Manufacturing plants need to be sure that their instrumentation products – temperature sensors. having a reliable. If stoppages to production lines due to equipment breakdowns are costly. flow meters and the like – are performing and measuring to specified tolerances. including pharmaceuticals. pressure transducers. where equipment and plant infrastructure is large. profitability and growth. furnaces.
In the process industries. safety issues or batches of inferior quality goods being produced. the consequences can be disastrous. especially if the company is part of an asset-intensive industry. In the process industries. boilers. has proved itself time and time again across many industry sectors. is critical to business efficiency. chemicals. perhaps resulting in costly production downtime. a small. Beamex® CMX. For this. metal processing.successfully executing a system integration project
Successfully executing a system integration project
or process manufacturers today. special purpose machines. implementing the latest computerized maintenance management systems (CMMS) might save precious time and money. or across multiple sites. seamlessly integrated set of IT systems across the plant. Maintaining plant assets – whether that includes production line equipment.
. conveyor systems or hydraulic pumps – is equally critical for these companies. oil and gas. If sensors drift out of their specification range. complex and expensive. nuclear. paper. which then have to be scrapped. Beamex’s calibration management software.
successfully executing a system integration project
Seamless communication Today. Then. 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. in-house software for maintenance management.
Beamex® CMX Professional or Beamex® CMX Enterprise software can easily be integrated to CMM systems. and the ability to speed up the calibration task. Calibration work orders can easily be transferred to CMX Calibration Software. once the calibration work order has been executed. whether it is a Maximo. CMX also stores the complete calibration history of process instruments and produces fully traceable calibration records. like procedures. plan. CMX sends an acknowledgement order of this work back to the customer’s CMM system. Seamless communication with calibrators also provides many practical benefits such as a reduction in paperwork. most process manufacturers use some sort of computerized maintenance management system (CMMS) that sits alongside their calibration management system. schedule.
. reminders and safety-related information. Seamless communication between CMX and ‘smart’ calibrators means that companies have the ability to automate predefined calibration procedures. Integration project A customer may have a large CMM system and a considerable amount of data keying to perform before integration is complete. All detailed calibration results are stored and available on the CMX database. As well as retrieving and storing calibration data. the customer and the CMM system software partner. in-house software for maintenance management. Integrating CMX with a CMM system means that plant hierarchy and all work orders for process instruments can be generated and maintained in the customer’s CMM system. elimination of human error associated with manual recording. A data exchange module or interface that sits between the two systems is required. Beamex® CMX helps companies document. CMX can also download detailed instructions for operation before and after calibrating. The integration project involves three main parties: Beamex. whether it is a Maximo. SAP or Datastream CMM system or even a company’s own. analyze and optimize their calibration work.
successfully executing a system integration project
Project organization and resourcing In order to have a successful integration. as a successful project requires input from both parties. A schedule is usually defined for the completion of the entire project as well as for the completion of each project phase. a project steering group may need to be established. tasks and authority of the project steering group must be defined as well as the decision-making procedures. Each project phase should be approved according to the acceptance procedures defined in the offer.
. a project organization should be established and include members from both the supplier’s and the customer’s organization. Scope of Work 2. Moreover. project plan or other document annexed to the offer / agreement. The role. The role of each member should be defined and project managers appointed.
The integration project involves three main parties: Beamex. the customer and the CMM system software partner. The project steering group is responsible for making key decisions during the project. Installation. In addition. The project manager is usually responsible for the operative management of the project. It’s also essential that the main roles and responsibilities of the parties are specified before the project evolves. agreement. it’s important that the right people and decision-makers are involved and participate right from the beginning of the project. Verification and Training The four main phases are also often divided into sub-phases. Testing 4. Project phases The integration project is divided into four main phases: 1. Development and Implementation 3.
The scope of work should include a brief project description. If the scope of work is not defined carefully.successfully executing a system integration project
Scope of work To ensure successful integration with a satisfied customer. The scope of work is important to make sure that both the supplier and the customer have understood the project in question and they have similar expectations from it. defining the correct scope of work (SOW) is crucial. However. questions or problems may appear later in the project. as the resourcing. it is important that the supplier and customer agree on change management procedures as early as the starting phase of the project.
. as changes to the original scope of work may be necessary and required even in projects where the SOW phase has been done carefully. 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. services provided. scheduling and costs of the project depend greatly on the scope of work. partner responsibilities and the desired outcome. The SOW is often developed through pre-studies and workshops. Defining what is not included in the scope of work is just as important as defining what is included in it. which will direct the project back to phase one where a review of the scope is necessary. This means that establishing some framework and limitations for the project are also very important. main roles.
Installation. assist with informing. the customer has a system that saves time. approval procedures and timelines should be defined when agreeing on the project. the customer has a system that saves time. in order to be able to continue the development work to next phase. training and providing training materials. 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. The testing. The project manager at the buyer’s facility now plays a major role in the success of the integration process. Testing Testing occurs both during the project after each partial delivery. verification and training The final stage in the integration process is the installation and testing at the customer’s facility and taking the system into production use. the integration can enter the next phase.
• Purpose / needs • Target • Supplier’s responsibilities • Customer’s responsibilities • Project management and project steering group
Scope of work (SOW)
• Change management
Development and implementation
• Testing and acceptance procedures
• Final approval by customer
Installation Veriﬁcation Training
FOLLOW UP CLOSURE OF INTEGRATION PROJECT
. which is the actual development and implementation of the project deliverables.successfully executing a system integration project
Development and implementation When the scope of work has been defined and approved by both parties. When the integration is finished. if required and agreed. reduces costs and increases productivity by preventing unnecessary double effort and rekeying of procedures in separate systems. and at the final stage of the project. The supplier will.
the most common benefits being: less equipment breakdowns (leading to a reduction in overall plant downtime). particularly with production teams.
systems.successfully executing a system integration project
Integrating a CMM system with calibration management software is an important step in the right direction when it comes to EAM. the data has to be as close to 100% accurate as possible to get maximum benefit from the system. Enterprise Asset Management. A CMMS integration will enable the customer company to automate its’ management with smart calibrators. However. and optimized scheduling of maintenance tasks and resources. Savings from EAM are reasonably well-documented and come in various guises. 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. more efficient use of maintenance staff. Enterprise Asset Management. better management of spare parts and equipment stocks. 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. When there is no need to manually re-key the data. EAM is more than just maintenance management software. But the key to success is really the quality of information you put in the software. a corresponding increase in asset utilization or plant uptime. This improves the quality of the entire system.
Calibration in Industrial Applications
including frequency and pulses. safety or custody transfer. Some calibrators can read HART. The purpose of calibration itself is to determine how accurate an instrument or sensor is. In plant areas where instrument accuracy is critical to ensure product quality. regular calibration of instruments throughout a manufacturing plant is common practice. temperature and electrical signals. 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.
Many process plants are under pressure to calibrate instruments quickly but accurately and to ensure that the results are then documented for quality assurance purposes and to provide full traceability. calibration every six months – or even more frequently – is not unusual. However. the key final step in any calibration process – documentation – is often neglected or overlooked because of a lack of resources. many process plants are under pressure to calibrate instruments quickly but accurately and to ensure that the results are then documented for quality assurance purposes and to provide full traceability. 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. and then automatically documenting the calibration results by transferring them to a fully integrated calibration management software. Indeed. time constraints or the pressure of everyday activities. Foundation Fieldbus or Profibus output of the transmitters and can even be used for configuring ‘smart’ sensors. Although most instruments are very accurate these days.
.the benefits of using a documenting calibrator
The benefits of using a documenting calibrator
or process manufacturers.
” With a multi-functioning documenting calibrator. which makes the entire process much faster and consequently reduces costs. Calibration results have to be keyed manually into a separate database. As Laurila states. “Engineers. the calibration procedure itself is critical. as well as detailed instructions on how to calibrate the transmitter. again. “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. but which also integrates and automatically transfers this information to some sort of calibration management software. especially if calibration is one of the many tasks that the user has to carry out in his daily maintenance routine. who are out in the field performing instrument calibrations. the calibration results are stored automatically in the calibrator’s memory during the calibration process.
By using a documenting calibrator. the calibration procedure can be automatically transferred from the computer to the handheld calibrator before going out into the field. This means the engineer does not have to spend time transferring the results from his notepad to final storage on a computer. With a documenting calibrator. The tolerances and limits for a sensor. are entered once into the calibration management software and then downloaded to the calibrator. having an easy-touse documenting calibrator is definitely the way forward. Performing the calibration procedure in the same way each time is important for the consistency of results. such as the
.the benefits of using a documenting calibrator
Heikki Laurila. Why use a documenting calibrator?
The engineer does not have to write any results down on paper. spreadsheet or paper filling system. saving time and money. This means calibrations are carried out in the same way every time because the calibrator tells the engineer which test point he needs to measure next. The quality and accuracy of calibration results will also improve. receive instant pass or fail messages with a documenting calibrator. With instrument calibration. The calibration results are automatically transferred from the calibrator’s memory to the computer/database. Also. Product Manager at Beamex in Finland comments. which makes the entire process much faster and consequently reduces costs. as there will be fewer mistakes due to human error. or stores calibration data from instruments but is not integrated to a calibration management system. The engineer does not have to write any results down on paper.” A non-documenting calibrator is a device that does not store data.
January.” Having a fully integrated calibration management system – using documenting calibrators and calibration management software – is important.
. Beamex® CMX Calibration Software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. 2004
Calibration software ensures that calibration procedures are carried out at the correct time and that calibration tasks are not forgotten. Laurila continues. typically with five-point checks on each instrument. the user doesn’t need to carry as much equipment while out in the field. Benefits in practice Conventional calibration work relies on manual. Using the MC6 or MC5 with CMX software means that calibration instructions for an instrument and calibration orders are downloaded to the calibrators and ready to guide the engineer in the field with correct calibration procedures.the benefits of using a documenting calibrator
Beamex® MC5 or MC6. speed and accuracy are critical. Manual calibration takes more time and is more prone to error. 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 % . “With a documenting calibrator. such as the MC5 or the MC6. Foundation Fieldbus H1 or Profibus PA transmitters. 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. This means the user can work in the field for several days. configure and trim HART. overlooked or overdue. paper-based systems for documenting. the user can download calibration instructions for hundreds of different instruments into the device’s memory before going out into the field. and the system provides full traceability.
___________________ * Reported to the Industrial Instrumentation and Controls Technology Alliance and presented at the TAMU ISA Symposium. overlooked or overdue. Unintentional errors often occur and the whole process is timeconsuming. the field engineer calibrates the instrument. When you’ve got to calibrate instruments throughout a site. the calibration process is much faster. handwrites the results onto a paper form and then reenters this information into a database when he returns to the office.* Why? Because the devices provide higher accuracy. Oftentimes. Both calibrators can be used also to calibrate.
again. • No manual printing or reading of calibration instructions is required. This not only ensures full traceability but also reflects full and traceable documentation of the completed work.
• Calibration results are automatically stored in the calibrator’s on-board memory during the calibration procedure. • The calibration procedure itself is guided by the calibrator. consistency and quality of calibration results.
. • Reduced costs from a faster and more efficient calibration process. which uploads detailed instructions from the computer or calibration management software. the system provides a full quality assurance report of all instruments calibrated along with a required calibration certificate. • A fully traceable calibration system for the entire plant. saving time and money and simplifying the process.the benefits of using a documenting calibrator
After completing instrument calibrations. • Calibration results are automatically transferred from the calibrator’s memory to a computer or fully integrated calibration management system.
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. • Improved accuracy. • Less paperwork and fewer manual errors.
Using weighing instruments for legal purposes must have legal verification. In any case. it is the owner or the user of the instrument that carries the final responsibility of measurement capability and who is also responsible for the processes involved.
. One of these features includes making measurements for which legal verification is required. If a weighing instrument is used in a quality system.calibration of weighing instruments part 1
Calibration of weighing instruments Part 1
rom the point of view of the owner. at least in Europe. (S)He must select the weighing instrument and maintenance procedure to be used to reach the required measurement capability. but in the EU they are the same. Calibration depicts the deviation between indication and reference (standard) including tolerance. the quality of a weighing instrument is already defined in OIML regulations. Calibration and legal verification Weighing instruments may also possess special features. From a regulatory point of view. whereas verification depicts the
In any case. and the user must have the knowledge to apply the information achieved through calibration. for example when invoicing is based on the weight of a solid material. should provide the correct weighing results. Verification and calibration abide by a different philosophy. usually called scales or balances. the user must define the measurement capability of it. Calibration is a means for the user to obtain evidence of the quality of weighing results. at least at the stage when the weighing instrument is being introduced into use. weighing instruments. it is the owner or the user of the instrument that carries the final responsibility of measurement capability and who is also responsible for the processes involved. The features may vary slightly from country to country. How the weighing instrument is used and how reliable the weighing results are can be very different.
if necessary. this means investigating the efficiency of the weighing instrument. and for weighing technology in general. are based on these practices of calibrating and verifying. This is a feasible practice for all weighing. Comparing the indication of weighing instruments with a set standard gives the deviation or error. hysteresis. Using a calibration program. this operation is known as calibration (or verification). even if it was a question of general weighing (non-legal). we need more information about the weighing instrument. The terminology and practices used previously for verifying measurement capability. eccentric load. and it displays the history of calibrations and in this way provides the user with comprehensive information concerning measuring capability.
. It is also handy for monitoring measuring systems. etc. The method should be precise for achieving comparable results during all calibrations. 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. such as repeatability. 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. We must remember that the quality of the evaluation of measuring tolerance depends on the collected information through calibration. including information for other measuring devices. which goes through the same steps for every calibration – calculates deviation and measuring tolerance. produces a calibration certificate – is the best way to achieve reliable information to use in comparisons. as long as legal verification is not needed. and. In practice. The method of calibration should be selected such that it provides sufficient information for evaluating the required measuring tolerance.calibration of weighing instruments part 1
maximum permissible amount of errors of the indication. The practical work for both methods is very similar and both methods can be used to confirm measurement capability. to be able to define the measuring tolerance. One calibration provides information on a temporary basis and a series of calibrations provides time-dependent information. 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. However.
is a short-term process. Performing calibrations based on the measuring tolerance is better than doing routine measuring. Therefore. as well as calibration personnel.
. The factors in question may include the effect of the environment where the weighing instrument is used and how often the instrument needs to be cleaned. the user must determine all of the external factors which may influence the proper functioning of the weighing instrument. The user must define the limits for permitted deviation from a true value and required measuring tolerance. however. 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. Calibration itself. a quality system is usually concerned with the traceability of measurements and the known measuring tolerance of the measurements made. 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.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. They possess several possibilities for adjusting parameters in measuring procedures. is a short-term process. as well as many other instruments. the idea is that the weighing instrument remains in good working condition until the next calibration. the function of weighing instruments. If these values are exceeded. regular monitoring of the zero point and the indication number with a constant mass. an adjustment or maintenance is necessary. Since there are several parameters in use. it is important to always have the manual for using the weighing instrument easily available to the user. is based on microprocessors. Today. It is very important that the users of the weighing instruments. however.
Calibration itself. Calibration should be carried out using settings based on the parameters for normal use. are familiar with these parameters and use them as protocol. For this reason. the user must evaluate the process of measuring tolerance and compare this value with the required measuring tolerance of the process. However. the idea is that the weighing instrument remains in good working condition until the next calibration.
It also assists the user in obtaining the required quality of measurements in a process.calibration of weighing instruments part 1
Calibration (or verification) is a fundamental tool for maintaining a measuring system.
. The following must be taken into consideration: • the type of procedure to be applied in confirming measuring tolerance • the interpretation of information while abiding by the calibration certificate • changing procedures based on received information Quality calibration methods and data handling systems offer state-of-the-art possibilities to any company.
calibration of weighing instruments part 1
the object being weighed is placed on the load receptor and the weighing result is read only once. i. 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. Subsequently. i. tests for determining minimum weighing capability are also performed. but users. the equipment was tested or calibrated on a regular basis. Guidelines on the Calibration of Non-automatic Weighing Instruments. and published by the European Collaboration in Measurement and Standards (euromet). Weighing instruments are often highly accurate.calibration of weighing instruments part 11
Calibration of weighing instruments Part 2
eighing is a common form of measurement in commerce. Originally.
. often need to know just how inaccurate a particular scale may be. often need to know just how inaccurate a particular scale may be. Typical calibration procedures Calibrating scales involves several different procedures depending on national. this information was obtained by classifying and verifying the equipment for type approval. Repeated weighing measurements provide different indications Usually.e. but users.e.and/or industry-specific guidelines or regulations. their customers and/or regulatory bodies. If you weigh the object
Weighing instruments are often highly accurate. or on the potential consequences of erroneous weighing results. their customers and/or regulatory bodies. One clear and thorough guide is the EA-10/18. which was prepared by the European Co-operation for Accreditation. industries and households.
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.73%. This condition is met if the measurement error is less than 0. you will notice slight.e. which can be assuredly and accurately measured using the scale in question. random variation in the indications. their customers and/or regulatory bodies. Substitution mass should also be used if the construction of the scale does not allow the use of standard weights.calibration of weighing instruments part 11
repeatedly. You must also know how certain you can be about the error found at each point of calibration. it may be impractical to use standard weights for calibrating the entire range.:
Weighing instruments are often highly accurate. suitable substitution mass is used instead. This enables you to correct the errors and definitions for non-linearity and hysteresis. Center of gravity matters The eccentricity test involves placing the object being weighed in the middle of the load receptor as accurately as possible.g. i. but users. Typical calibration procedures include the eccentricity test. e. There are several sources of uncertainty of the error. A truck scale is unsuitable for weighing letters The purpose of the minimum weight test is to determine the minimum weight. Test for errors in indication The weighing test examines the error of the indication on the scale for several predefined loads. often need to know just how inaccurate a particular scale may be. 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. The repeatability test involves weighing an object several times to determine the repeatability of the scale used.1% of the weight. with a probability of 99. In such a case. If the scale’s maximum load limit is extremely large.
which correspond to one standard deviation of a normally distributed variable. • Analogous scales have limited readability. • There are random variations in the indications as can be seen in the Repeatability Test.27%).9 g 4.8 g and 3. air temperature and humidity.g. is between is between 1.5 g and u(E) = ±0. • Digital scale indications are rounded to the resolution in use.6 g
Example: The calibration error and its uncertainty at the calibration point of 10 kg may be expressed e. E = 2. • The weights are not in the exact middle of the load receptor.calibration of weighing instruments part 11
• The masses of the weights are only known with a certain uncertainty.5 g ±u(E) 68.
1.27% as well.27%. with a coverage probability of 68.2 g 3. • A substitute load is used in calibrating the scale.5 g and the actual error.45 % U(E) = 3u(E) 99.27% U(E) = 2u(E) 95.2 g. The values of uncertainty determined at each point of calibration are expressed as standard uncertainties (coverage probability: 68.8 g 0.1 g 2. The combined standard uncertainty of the error at a certain point of calibration has a coverage probability of 68. • Air buoyancy around the weights varies according to barometric pressure.73 %
. which means that the calculated error in the indication is 2. • Air convection causes extra force on the load receptor.4 g 1.
barometric pressure and relative humidity of the air may vary. you know that if you repeat the calibration several times.45%. the indication of weighing an object of 10 kilograms will be between 10. is between 1. Uncertainty of a weighing result The purpose of calibration is to determine how accurate a weighing instrument is. However. with a coverage probability of 95. or the reliability of the standard uncertainty value is insufficient. This means that the calculated error of the indication is 2. knowledge of its typical behaviour and knowledge of the conditions of the location where the instrument is used.0011 kg and 10. at least once.9 g. As the above-mentioned case indicates.calibration of weighing instruments part 11
Expanded uncertainty in calibration U(E) In practice.
.45% of the time. the uncertainty of the results of later routine weighings is usually larger. • The adjustment of the weighing instrument may have changed. for all
The purpose of calibration is to determine how accurate a weighing instrument is. • Tare balancing device may be used in routine weighing. Standard and expanded uncertainties of weighing results are calculated using technical data of the weighing instrument. a coverage probability of 68. its calibration results.0039 kg 95. Typical reasons for this are: • Routine weighing measurements involve random loads. then the error and its extended uncertainty at the point of calibration are E = 2. If the distribution of the indicated error cannot be considered normal. • The temperature. while calibration is made at certain calibration points. Normally. then a larger value should be used for the k-factor. If you are able to use the k = 2 coverage factor. • Loading/unloading cycles in calibration and routine weighing may be different. • A load may be situated eccentrically in routine weighing. Defining the uncertainty of weighing results is highly recommended.5 g and U(E) = ±1.1 g and 3.5 g and the actual error. • Finer resolution is often used in calibration. • 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 = 2.27% is insufficient. it is extended to a level of 95.4 g.
Wide variation in user-specific limits is also possible.
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. copying configurations from one scale to another is easy. However. CMX’s versatile calibration certificate and possibility to define a user specific certificate assure that you can fulfill requirements set for your calibration certificates. determining the uncertainty of weighing results is not part of calibration. CMX calculates combined standard uncertainty and expanded uncertainty at calibration of the weighing instrument. It allows you to enter additional. Calculating the uncertainty of weighing results assists you in deciding whether or not the accuracy of the weighing instrument is sufficient and how often it should be calibrated. Calibrating and testing weighing instruments using CMX CMX’s scale calibration enables you to uniquely configure calibration and test each weighing instrument. user-defined uncertainty components in addition to supported uncertainty components. Correspondingly.calibration of weighing instruments part 11
typical applications and always for critical applications.
they nevertheless do not determine the permanency of accuracy. T/C).g. a model that includes all influencing factors must be created.
. The polynoms are specified in ITS 90 table (International Temperature Scale of 1990). It is important to keep in mind an old saying: all meters. makes it different from other quantities. Temperature. For each measurement. Temperature sensors The most commonly used sensors in the industry used for measuring temperature are temperature sensors. the user must be sure to verify the permanency of accuracy. They either convert temperature into resistance (Resistance Temperature Detectors. While standards determine accuracy to which manufacturers must comply. and its influence on e. which makes the temperature calibration process slow and expensive. Temperature greatly influences many physical features of matter. Every temperature measurement is different. being a state of equilibrium. calibration will prove by how much. show incorrectly. Therefore. RTD) or convert temperature into low voltage (Thermocouples. Metrology contains mathematic formulas for calculating uncertainty. A temperature measurement consists of several time constants and it is crucial to wait until thermal equilibrium is reached before measuring. quality. it is necessary to calibrate the instrument and the temperature sensor. they nevertheless do not determine the permanency of accuracy. including sensors. RTD’s are based
While standards determine accuracy to which manufacturers must comply.calibrating temperature instruments
Calibrating temperature instruments
he most commonly and most frequently measurable variable in industry is temperature. If temperature is a significant measurable variable from the point of view of the process. energy consumption and environmental emission is significant.
and performing calibration is not the least influencing factor. it also has an impact on the total accuracy. 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. Despite their lower sensitivity (low Seebeck coefficient). All heat
. temperature transmitters were developed to convert the sensor signal into a format that can be transmitted easier. This means that the thermocouple is not measuring the temperature. transmitters with a digital output signal. the transmitter converts the signal from the temperature sensor into a standard ranging between 4 and 20 mA. Therefore. PtRh/Pt/Rh) are used especially in high temperatures for better accuracy and stability. The heat source may also have an internal temperature measurement that can be used as reference. it must be inserted into a known temperature. the noble thermo-elements S-.
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 the difference in temperature. The most common T/C type is the K-type (NiCr/NiAl). Calibrating temperature instruments To calibrate a temperature sensor. an external reference temperature sensor is recommended. Pt100 is a common RTD type made of platinum and its resistance in 0 ˚C (32 ˚F) is 100∧. Nowadays. but to achieve better accuracy and reliability. Sensors are calibrated either by using temperature dry blocks for industrial field or liquid baths (laboratory). and therefore the transmitter must be calibrated on regular basis.calibrating temperature instruments
on the fact that the resistance changes with temperature. Many factors influence the total uncertainty. R. Thermocouple consists of two different metal wires connected together. To make comparisons. A temperature transmitter can be calibrated using a temperature calibrator. The uncertainty of calibration is not the same as the accuracy of the device. we compare the sensor to be calibrated and the reference sensor. If the connections (hot junction and cold junction) are at different temperatures. are also being adopted.or B-type (PtRh/Pt.
Temperature transmitters The signal from the temperature sensor cannot be transmitted a longer distance than the plant. Most commonly. a small temperature dependent voltage difference/current can be detected.
Radial homogeneity Radial homogeneity can be explained as the difference in temperature occurring between the borings. Stability Stability means variation of the temperature in the measurement zone over time when the system has reached equilibrium. heat flux along the length of the thermometer stem. stability and immersion depth. Loading effect When several sensors are placed in the borings of the heat source.
The uncertainty of calibration is not the same as the accuracy of the device.calibrating temperature instruments
sources show measurement errors due to their mechanical design and thermodynamic properties. These effects can be quantified to determine the heat source’s contribution to the measurement uncertainty. The major sources of measurement uncertainty are axial homogeneity. Immersion depth To achieve a more stable calibration.
Axial homogeneity Axial homogeneity is the temperature distribution in the measurement zone along the boring (axial temperature distribution).01 (former EA-10/13). radial homogeneity. loading effect. affects both the reference sensor and the unit being tested. the immersion depth for a probe should be sufficient for the sensor being calibrated. Guidelines for minimizing measurement uncertainty should be applied according to Euramet/cg-13/v. Thirty minutes is commonly used. This phenomenon is called loading effect. Stem conduction. they will affect accuracy.
says Raimo Ahola. calibration software and PC for online calibration. It is a complete solution for temperature calibration with various products and services. the calibration device must always be more accurate than the instrument or sensor being calibrated. The instrument to be calibrated is connected to the calibrator controlled by a computer. which is useful in making decisions about purchasing new instruments. smart reference probes and temperature calibration laboratory services. the calibration device must always be more accurate than the instrument or sensor being calibrated. The ISO quality control system presupposes the quality control of calibration. the calibration of instruments effecting production. both in numeric and in graphic form. more accurate and efficient management of all calibration assets and procedures”. where the computer controls the calibration event. However. Integrated calibration solution – a smarter way to calibrate temperature Beamex has introduced a smarter. you can print out a calibration report as well as a traceable. a complete calibration solution that enables faster. The calibration results can then be uploaded from the documenting calibrators to the Beamex® CMX Calibration Software. CEO of Beamex Group. With the CMX Software. The level of performance a calibration device needs to have depends on the accuracy requirements determined by each company. more efficient and accurate solution for calibrating temperature. Calibration of instruments and sensors can be carried out either on site or in a laboratory. The Beamex® FB and MB dry blocks are part of the Beamex® Intergrated Calibration Solution.
However.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. such as a series of highquality dry blocks for field and laboratory use. The instrument’s calibration information is saved in the calibrator and History Trend reports. The dry blocks communicate with the Beamex documenting multifunction calibrators enabling fully automated temperature calibration and documentation. The Beamex® Integrated Calibration Solution concept is the combination of calibrator. determining service in advance and recalibration. “This helps the client to follow the condition of the instrument.
. regular calibration of sensors and traceable calibration as well as calibration documentation.
Our integrated calibration solution concept saves valuable time.
. Mr Ahola adds.calibrating temperature instruments
accredited calibration certificate. eliminates any errors related to manual entry and assures repeatable calibration procedures”.
The Beamex® Integrated Calibration Solution concept is the combination of calibrator. calibration software and PC for online calibration.
Dry blocks are almost without exception meant to be used dry.total uncertainty of temperature calibration
Calculating total uncertainty of temperature calibration with a dry block
his article will discuss the various uncertainty components related to temperature calibration using a temperature dry-block. It will also present how to calculate the total uncertainty of a calibration performed with a dry block. This article will focus on models that use interchangeable metallic multi-hole inserts. in temperatures above 200 °C liquids can produce undesirable fumes or there may be fire safety issues. If a drop of water gets into hot silicon oil. EURAMET The EURAMET guideline (EURAMET /cg-13/v. controller. There are fast and lightweight dry blocks for industrial field use as well as models that deliver near bath-level stability in laboratory use. For example.01. Heat transfer fluids or pastes are sometimes used around or inside the insert. What is a temperature dry block? A temperature dry block consists of a heatable and/or coolable metallic block. There are also some work safety issues that favor dry blocks in preference to liquid baths.
. an internal control sensor and optional readout for external reference sensor. but they don’t necessarily improve performance. 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. it could even cause a small steam explosion which may splash hot oil on the user. They may actually even impede the dry block’s performance and damage its internal components.
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. It is possible to use a dry block with the block’s internal measurement as the reference (true value). the products are easier to compare. Some manufacturers specify these components and some do not. Internal measurement as reference When using a dry block’s internal measurement as reference. • 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.
. There is always thermal resistance between the internal sensor and the probes inside the insert and other sources of uncertainty need to be considered.5 mm at –80…660 °C) (<= 1. With dry blocks. the internal control sensor is typically located inside the actual block. whereas the probes to be calibrated are immersed in the insert. or to use an external reference temperature probe inserted in the block as a reference measurement. 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.
The Euramet calibration guide defines a normative way to calibrate dry blocks.total uncertainty of temperature calibration
dry blocks. As most of the manufacturers nowadays publish their product specifications including the main topics in the Euramet guide.
. “dry wells should have a zone of sufficient temperature homogeneity of at least 40 mm in length” at the bottom of the insert. Non-symmetrical loading or probes with significantly different thermal conductivity (for example large diameter probes) may cause additional temperature variation. The Euramet calibration guide states.
• Axial uniformity Axial uniformity refers to the variation in temperature along the vertical length of the insert. for example. Related uncertainty is caused. by the placement of the heaters. The thermocouple typically has its “hot junction” close to the tip of the probe whereas the PRT sensing element may be 30 to 50 mm long. a homogenous zone of at least 60 mm is recommended. With this in mind. The purpose of this homogenous measurement zone is to cover various sensor constructions. thermal properties of materials and alignment of the insert holes. • Radial uniformity Radial uniformity refers to the variation in temperature between the holes of the insert.total uncertainty of temperature calibration
MAIN PARTS OF THE DRY BLOCK
Stem conductance Sensor to be calibrated Reference sensor Axial uniformity
Uncertainty components that are related to temperature calibration are relevant to all manufacturers’ dry blocks.
• 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. The loading effect is not visible in the control sensor indication and the controller cannot completely compensate for this shift. The more the load. as a rule of thumb. to use immersion depth of 20 x the diameter. it should be estimated or evaluated.
Stability describes how well the temperature remains the same during a given time. Sufficient immersion depth and dual zone control helps to reduce load-related uncertainties.
. If some component has not been specified. To minimize the stem conduction error it’s recommended. – The Euramet calibration guide defines stability as a temperature variation over a 30-minute period. plus the length of the sensing element. • Hysteresis Hysteresis causes the internal sensor to be dependent on its previous exposure. wall thickness. The hysteresis is greatest at the mid-point and is proportional to the temperature range. As the probe constructions vary greatly (sheet material. • Immersion Sufficient immersion is important in any temperature measurement. 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. a test for each individual probe type to be calibrated should be made. the more the ambient temperature will affect the measurements. then the uncertainty caused by the insufficient immersion should be estimated/ evaluated. The Euramet calibration guide states that the immersion depth should be at least 15 x the probe’s outer diameter.). when the system has reached equilibrium. lead wire thermal conductivity etc. If sufficient recommended immersion cannot be reached. The specifications for the above uncertainty components should be in the block’s specifications.
the external reference sensor is within the same calibration volume as the sensors to be calibrated. Using an external reference sensor enables smaller total uncertainty of the system. • Loading effect Since the internal sensor cannot completely compensate the load related temperature shift inside 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 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 stem conductance has to be taken into account. mechanical robustness is usually inversely proportional to good performance: stability. the reference probe can be drawn out to match the immersion. The loading effect is usually much less significant with an external reference sensor. vibration and possible mechanical shocks so it has to be quite a robust mechanically. There are many advantages to using a separate reference sensor. the external reference enables more accurate measurement of the temperature of the probes to be calibrated. the user may obtain good results. In many cases. Unfortunately. The internal sensor is used just to adjust temperature close to the desired calibration point and keep it stable. Of course.
. etc. In the case of using an external reference sensor. Therefore. In case the probe to be calibrated is short and won’t reach the measurement zone at the bottom of the insert. the user can reduce the axial uniformity well below specification. The internal sensor has to deal with quick temperature changes. • Radial uniformity Radial uniformity is still present when using an external reference probe and should be taken into account as specified. the external reference sensor is inside the insert together with the probes to be calibrated. It helps to minimize calibration uncertainty but also provides reliability in measurements. hysteresis.
Using an external reference sensor enables more accurate measurement of the temperature of the probes to be calibrated. If the reference sensor and the sensor to be calibrated are sufficiently similar in diameter and thermal conductivity.
total uncertainty of temperature calibration
• Stability over time The external reference sensor can be used to measure the actual temperature deviation inside the insert. and it may often be smaller than the specification. It also helps the user to see when the unit has truly stabilized.
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. All of the previously mentioned uncertainty factors need to be carefully considered. Dry blocks usually have a stability indicator. drift. – Of course. but depending on. • External reference sensor – The external reference sensor (PRT) is typically much more capable of producing accurate measurements than the internal sensor. stem conduction. the external reference sensor needs a unit that measures the sensor. for instance. It can be the block or an external device. – Uncertainty related to the reference probe components includes the probe’s calibration uncertainty. and the readout device’s uncertainty. However. 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 different loads.
067 0.003 0.028
All specifications have a rectangular probability distribution.004 0.02 0. Finally the combined uncertainty has been multiplied by two to get the expanded uncertainty.014 0.01 0. That is why they are divided by the square root of three to get Standard Uncertainty. One is done using the internal temperature measurement and the other with a reference probe.006 0.005 0. In both cases the MB155R is used as the dry block.006 0.003 0.004 0.020 Standard Uncertainty (°C) 0.006 0.135
MB155R with external measurement @0 °C
Component Axial Uniformity Radial Uniformity Stability Loading Effect Ref sensor measurement Specification (°C) 0.012 0.014 0.029 0. Due to the rectangular probability distribution of the specifications. The various uncertainty components used in the examples can be found in the specifications in the product brochures.135 °C).
MB155R with internal measurement @0 °C
Component Display Accuracy Hysteresis Axial Uniformity Radial Uniformity Stability Loading Effect Specification (°C) 0.005 0.034 °C).005 0.05 Combined Uncertainty: Expanded Uncertainty: Standard Uncertainty (°C) 0.01 0.003 0.01 Combined Uncertainty: Expanded Uncertainty: MB155R and RPRT-420 Combined uncertainty: Expanded Uncertainty: 0.012 0. The standard uncertainties are combined as the root sum of the squares.006 0.058 0.01 0. The temperature in both examples is 0 °C.010 0.total uncertainty of temperature calibration
■ Here are two examples of total uncertainty calculations.017 0. they are divided by the square root of three to get the Standard Uncertainty.02 0.034 Standard Uncertainty (°C) 0.006 Combined Uncertainty: Expanded Uncertainty: Reference Sensor (Beamex RPRT-420) Component Short-term repeatability Drift Hysteresis Calibration uncertainty Specification (°C) 0. As can be seen in the examples the total expanded uncertainty using the internal reference sensor is 135 mK (0.
.007 0.003 0. When using an external reference sensor the total expanded uncertainty is 34 mK (0.10 0.025 0.007 0.
Fieldbus transmitters are able to deliver a huge amount of information via the quick two-way bus. History of fieldbus Back in the 1940s. A standard was finally set in the year 2000 when the IEC61158 standard was approved. instrumentation utilized mainly pneumatic signals to transfer information from transmitters. one way. Conventional I/O systems are no longer needed because segment controllers connect the instrument segments to the quicker. the mA signal was introduced. Each transmitter needs a dedicated pair of cables. The first fieldbus was introduced in 1988. The
Fieldbus transmitters must be calibrated as well. instruments from any manufacturer can be connected to the same fieldbus as plug-and-play. computerized control systems began to make their arrival. but how can it be done? Conventional transmitters can deliver only one simultaneous parameter. The first digital. During the 1990s. Being an open standard. Several transmitters can be connected to the same pair of wires. and I/O subsystems are required to convert the analog mA signal to a digital format for a control system. But what is fieldbus and how does it differ from conventional instrumentation? Fieldbus transmitters must be calibrated as well. making things much easier. In the 1970s. and throughout the 1990s a number of various fieldbuses were developed. smart transmitter was introduced in the 1980s. higher-level fieldbus backbone. During the 1960s. manufacturers battled to see whose fieldbus would be the one most commonly used. using first proprietary protocols.fieldbus transmitters must also be calibrated
Fieldbus transmitters must also be calibrated
ieldbus is becoming more and more common in today’s instrumentation. but how can it be done?
Remote configuration also helps to support reduced downtime. if it would not offer them benefits compared to alternative systems.
. This is caused by many reasons. There are also certain applications that prefer certain fieldbus installations despite the geographical location. or even a little bit more.
The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus market. lower installation labour cost. one can say that the Foundation Fieldbus is dominating the North American markets and the Profibus is the market leader in Europe. The Foundation Fieldbus and Profibus have begun to clearly dominate the fieldbus markets. Other areas are more divided. a large number of fieldbus installations already exist and the number is increasing at a huge rate. Although fieldbus hardware may cost the same as conventional. Another big advantage is the on-line self-diagnostics that helps in predictive maintenance and eventually reduces the downtime. less planning/drawing costs. Critical applications and hazardous areas have also begun to adopt fieldbus. such as reduction in field wiring. Recent co-operation between Foundation Fieldbus and Profibus suppliers will further strengthen the position of these two standards. The development of new fieldbuses has slowed down and it is unlikely that new fieldbus standards will appear in the near future to challenge the position of Foundation Fieldbus or Profibus. Future of fieldbus Currently. Fieldbus benefits for industry Obviously process plants would not start utilizing fieldbus. There are also other advantages compared to conventional instrumentation. both used in process instrumentation. were chosen as standards. For the most part. A large portion of new projects is currently being carried out using fieldbus. The improved system performance is important criteria for some plants. offering maintenance savings. the total installation costs for a fieldbus factory is far less than conventional. Both Foundation Fieldbus and Profibus have reached such a large market share that both buses will most likely remain also in the future.fieldbus transmitters must also be calibrated
Foundation Fieldbus H1 and the Profibus PA. One important reason is the better return on investment. and no need for conventional I/O subsystems.
such as quality systems and regulations. Also. Reading the digital output is not always an easy thing to do. Naturally these two people need to communicate with each other in order to perform and document the calibration. Changing the output signal does not change the need for periodic calibration. There are also many other reasons.
. but you also need to have a way to read the output of the fieldbus transmitter. you need to find other ways to read the transmitter’s output. 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. The other parts of a fieldbus transmitter are mainly comparable to conventional or HART transmitters. So it is not possible to calibrate a fieldbus transmitter using only a configurator or configuration software. “calibration” is often used to mean the configuration of a transmitter. In some cases you can use a portable fieldbus communicator or a laptop computer with dedicated software and hardware. “calibration” means that you compare the transmitter to a traceable measurement standard and document the results. it does not eliminate the need for calibration. When fieldbus is up and running. or even a little bit more. In fieldbus terminology. In terminology pertaining to metrology. it is not possible to calibrate a fieldbus transmitter remotely. Calibrating fieldbus transmitters The word “calibration” is often misused in the fieldbus terminology when comparing it to the meaning of the word in metrology. The input is measured with a traceable calibrator. Although modern fieldbus transmitters have been improved compared to older transmitter models.
Although fieldbus hardware may cost the same as conventional. While your fieldbus and process automation systems are idle. the total installation costs for a fieldbus factory is far less than conventional. that make the periodic calibrations compulsory. 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.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.
There is no need for an additional communicator.
. time-consuming and may require an abundance of resources. The Beamex® MC6 can be used as a communicator for the configuration as well as a calibrator for the calibration of smart instruments with the supported protocols.fieldbus transmitters must also be calibrated
Fieldbus instruments are increasing in popularity and calibration can in many cases be cumbersome. The calibration results can be automatically stored into the memory of the MC6 or uploaded to calibration software. The Beamex® MC6 will help to overcome these challenges by combining a full field communicator and an extremely accurate multifunctional process calibrator.
The Beamex® MC6 can be used as a communicator for the configuration as well as a calibrator for the calibration of smart instruments with the supported protocols.
a modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. A microprocessorbased smart transmitter has a memory that can perform calculations.
. etc. temperature.configuring and calibrating smart instruments
Configuring and calibrating smart instruments
o called “smart” instruments are ever more popular in the process industry. The term “smart” is more of a marketing term than a technical definition. Generally. What is a “smart” transmitter? A process transmitter is a device that senses a physical parameter (pressure. The vast majority of delivered instruments today are smart instruments. produce diagnostics. in order for a transmitter to be called smart. the Beamex® MC6 –Advanced Field Communicator and Calibrator. that will help to overcome these challenges. it will utilize a microprocessor and should also have a digital communication protocol that can be used for reading the transmitter’s measurement values and for configuring various settings in the transmitter. the digital communication protocol is the biggest difference compared to conventional transmitters. for the engineers who need to configure and calibrate the transmitter. In any case.) and generates an output signal proportional to the measured input. Engineers can
A modern smart transmitter typically outperforms an older type of conventional transmitter regarding measurement accuracy and stability. These new smart instruments bring new challenges to the calibration and configuration processes. 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. Furthermore. etc. There is no standardized technical definition for what smart really means in practice.
Most of the protocols are based on open standards. sensor type. That brings a whole new challenge .
. including HART. So in order to do the configuration. Configuration One important feature of a smart transmitter is that it can be configured via the digital protocol. Foundation Fieldbus and Profibus PA protocols. no analog signal. The fieldbuses. i. The configuration needs to be done via the communication protocol. Since it also has the analog signal. a non-smart transmitter. to support the selected protocol. typically also called a communicator. Recently the HART protocol seems to be getting more boosts from the newest WirelessHART protocol.e. A HART transmitter contains both a conventional analog mA signal and a digital signal superimposed on top of the analog signal. The most common transmitter protocol today is the HART (Highway Addressable Remote Transducer) protocol.how can the digital output be read? Thinking of the opposite of a smart transmitter. WirelessHART. you will need to use some form of configuration device. it is not a reference standard and therefore cannot be used for metrological calibration. but they need to have the possibility to communicate with the transmitter and read the digital signal. would be a transmitter with a purely analog (or even pneumatic) output signal. but these seem to be fading out in popularity and favor is being given to protocols based on open standards because of the interoperability that they enable. This article will discuss “smart” transmitters. Some are proprietary protocols of a certain manufacturer.configuring and calibrating smart instruments
no longer simply measure the output analog signal. Configuration of a smart transmitter refers to the setting of the transmitter parameters. etc. it is compatible with conventional installations. Foundation Fieldbus and Profibus are gaining a larger foothold on the process transmitter markets.
It is crucial to remember that although a communicator can be used for configuration. These parameters may include engineering unit. contain only a digital output. Smart transmitter protocols There are various digital protocols that exist among transmitters considered smart. such as Foundation Fieldbus and Profibus.
by definition a traceable reference standard (calibrator) is always needed. However. Sometimes it is very difficult or even impossible to find a suitable device. In this case calibration is quite easy and straight forward. However. The calibration may. Calibration of a smart transmitter According to international standards. potential adjustments are often included when the calibration process is performed. be calibrated? Obviously the transmitter input still needs to be generated/measured the same way as with a conventional transmitter. with output being a digital protocol signal. it is not a reference standard and therefore cannot be used for metrological calibration. but in order to see what the transmitter output is. To calibrate a conventional.e. to see what the transmitter output is. a HART communicator is needed. If the calibration is done with a documenting calibrator.
The transmitter input needs to be generated/ measured the same way as with a conventional transmitter. i. especially a mobile one. or alternatively two separate singlefunction calibrators. For a real metrological calibration. i. calibration is a comparison of the device under test against a traceable reference instrument (calibrator) and documenting the comparison. which can read the digital output. several types of devices may be needed and several people to do the job.
. 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. by using a calibrator. you can generate or measure the transmitter input and at the same time measure the transmitter output. therefore. to do any configuration or trimming. by using a calibrator. be a very challenging task. you need a dual-function calibrator able to process transmitter input and output at the same time. Although the calibration formally does not include any adjustments.e. or to read the digital output signal (if it is used). it will automatically document the calibration results. The 4–20mA output signal of a wired HART transmitter is calibrated the same way as a conventional transmitter. analog transmitter. a device or software able to read and interpret the digital protocol is needed.configuring and calibrating smart instruments
It is crucial to remember that although a communicator can be used for configuration. you will need some device or software able to read and interpret the digital protocol. But how can a smart transmitter. Wired HART (as opposed to WirelessHART) is a hybrid protocol that includes digital communication superimposed on a conventional analog 4–20mA output signal.
When it comes to configuration of the smart transmitters. It has a large 5. All required electronics are built-in. typically only for one protocol (mostly HART) and offering very limited support. such as the pharmaceutical. There are some other “smart” process calibrators on the market with limited support for different protocols. The robust IP65-rated dustand water-proof casing. The MC6 also contains a full fieldbus communicator for HART. With the Beamex® MC6. The results can be automatically stored into the memory of the MC6 or uploaded to calibration software. and you can carry less equipment in the field. In practice. the smart transmitter’s input can be generated/ measured at the same time as reading the digital output. the MC6 includes a full field communicator for HART. service as well as the petrochemical and chemical industries. Foundation Fieldbus and Profibus PA instruments.
With the Beamex® MC6. including power supply and required impedances for the protocols. The MC6 is one device with five different operational modes. WirelessHART. Any additional communicator is therefore not needed. food and beverage. It offers calibration capabilities for pressure. calibrator. About Beamex® MC6 Beamex® MC6 is an advanced.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. which means that it is fast and easy to use. Foundation Fieldbus H1 and Profibus PA protocols. ergonomic design and light weight make it an ideal measurement device for field use in various industries. 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. temperature and various electrical signals. the smart transmitter’s input can be generated/ measured at the same time as reading the digital output. energy. oil and gas. The MC6 supports all of the protocol commands according to the transmitter’s device description file.
. The operation modes are: meter.7" color touch-screen with a multilingual user interface. The usability and ease-of-use are among the main features of the MC6. high-accuracy field calibrator and communicator. a separate communicator is needed in any case.
. Foundation Fieldbus and Profibus PA instruments. • Even the best instruments and sensors drift over time. • To achieve high and consistent product quality and to optimize processes. standards. • Regulatory requirements. data logger and Fieldbus communicator. the output protocol of a transmitter does not change the fundamental need for calibration.
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”.configuring and calibrating smart instruments
documenting calibrator.employee safety as well as customer/patient safety. the MC6 is more than a calibrator. especially when used in demanding process conditions. In addition. etc. So why would you calibrate them? First of all. environmental systems. • Safety reasons. the MC6 communicates with Beamex® CMX Calibration Software. In conclusion. such as quality systems. safety systems. There are numerous reasons to calibrate instruments initially and periodically. enabling fully automated and paperless calibration and documentation.
The MC6 also contains a full fieldbus communicator for HART. • Economical reasons – any measurement having direct economical effect. • Environmental reasons. A short summary of the main reasons include.
such as reactors that hydrogenate oils. many materials and fluids used in seemingly “safe” industries are themselves flammable. 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.
. pulp/paper. in many locations. For example. may pose hazards as well. Even seemingly safe water treatment systems use combustible materials such as chlorine in their processes.calibration in hazardous environments
Calibration in hazardous environments
triking a match in an environment that contains combustible gas is nothing short of dangerous – personal injury and property damage are likely consequences. retail. In addition. water/ wastewater. food. certain areas of food plants. The materials and fluids used in some processes can be hazardous in the sense that they can ignite or explode. oil refineries. Improperly calibrating an instrument in this hazardous environment can be almost as dangerous. Similarly. power generation. Therefore. hydrocarbons in mines. leaks. including agriculture. and chemical plants are flammable and are typically contained within vessels and pipes. combustible fuels. This means that certain areas of a water treatment plant may well be considered hazardous. Hydrocarbons and other flammable fluids are not limited to the petroleum and chemical industries. For example. If this were truly the case. pharmaceuticals. universities. and fluid accumulation may allow hydrocarbons to be present such that the flame could ignite the hydrocarbons with disastrous results. abnormal conditions. are used in all industries. such as natural gas. and in the home. an external flame would not ignite the hydrocarbons. However.
ib Flammable material present abnormally
In addition. installed. ib Flammable material present intermittently Zone 2 ia. 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.
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.calibration in hazardous environments
selected. In general. frequency of the hazard. The intensity with which various vapors can combust is generally different. the IS concept is to design the calibrator such that it limits the amount of energy available such that it cannot ignite a combustible gas mixture. Equipment requirements in hazardous locations Protection requirements for hazardous locations vary according to the type of material present. Adding the applicability of IS designs to various hazards in the previous table yields:
Zone 0 ia Flammable material present continuously Zone 1 ia. 170
. and maintained in accordance with practices that are appropriate for the hazard. Temperature classes limit the maximum surface temperature between 450˚C (T1) and 85˚C (T6). and the protection concept applied. a hot surface temperature on a device can cause ignition.
pulse. which means that many instruments are calibrated in the field.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. current. Fortunately. The ergonomic design and modular construction allow the user to select the necessary functions in a cost-effective manner. and other variables designed in hazardous locations are generally used to monitor and control the process. it is practical to remove these instruments and calibrate them on the workshop with a calibration test bench. This software generally makes calibration work faster and easier and is designed to integrate into management systems such as SAP and Maximo. This is usually not the case. pressure. thermocouple. they can be used for the overwhelming majority of applications where a vapor hazard is present. The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work. In some applications. The Beamex multifunction IS-calibrators are portable and intrinsically safe and have modules that can accommodate wide ranges and many types of pressure. but also automatically takes data. adheres to GMP regulations (21 CFR 11). temperature. 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. It not only alerts you when to calibrate. and tracks calibration history. voltage. level. there are calibrators that are specifically designed to operate safely in rugged environments and hazardous locations. RTD. creates documentation. Calibration solutions for hazardous locations Instruments designed to measure flow. and frequency measurements. As such.
The Beamex® CMX software integrates calibration management by allowing efficient planning and scheduling of calibration work.
• Portable Beamex calibrators for hazardous locations are designed to be used in virtually all vapor hazards. and maintained in accordance with requirements for the hazardous location. operated. • Hazardous locations can exist in virtually all industries.calibration in hazardous environments
A few points to remember • Improper actions in hazardous locations can result in property damage and bodily injury.
Hazardous locations can exist in virtually all industries. • Instruments should be specified.
. and in the home. installed. stores. stores. and in the home.
calibration in hazardous environments
but also safely. rigs and processing plants. Intrinsically safe calibrators are also often referred to being “Ex calibrators”. “calibrators for Ex Areas”. Intrinsically safe calibrators are designed for potentially explosive environments. 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. intrinsically safe fieldbus calibrators enter into the picture. and if it occurs it will exist only for a short time. 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. A hazardous atmosphere is an area that contains elements that may cause an explosion: source of ignition. 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. There are also industrial environments where the calibration of fieldbus instruments should not only be made accurately and efficiently. 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
ieldbus transmitters must also be calibrated just like conventional instruments. or “IS calibrators”. When safety becomes a top priority issue in calibration. such as oil refineries. By definition. Zone 2: an explosive gas & air mixture is not likely to occur in normal operation. such as gases. mists. vapors or combustible dust. a flammable substance and oxygen. The concept has been developed for safely operating process control instrumentation in hazardous areas. Zone 1: an explosive gas & air mixture is likely to occur in normal operation. Where is intrinsically safe calibration required? Many industries require intrinsically safe calibration equipment. intrinsic safety (IS) is a protection technique for safely operating electronic equipment in explosive environments.
the safest way to calibrate fieldbus instruments
pipelines and distribution centres. This eliminates the need of manual recording of calibration data and improves the quality and productivity of the entire calibration process. They can be used for calibration of pressure. Every intrinsically safe calibrator is delivered with a product safety note. as well as pharmaceutical plants. as they can be safely used in environments where the risk of an explosion exists. Secondly. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. petrochemical and chemical plants. Basically. 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). A documenting intrinsically safe calibrator. but in a safe way. First of all. any potentially explosive industrial environment can benefit from using intrinsically safe calibrators. What are the benefits of using intrinsically safe calibrators? There are clear benefits in using intrinsically safe calibration equipment.
Basically. which should be read carefully before using the device. temperature and electrical signals. Safest possible technique Intrinsically safe calibrators are safe for employees. such as the Beamex® MC5.
. Performance and functionality Multifunctional intrinsically safe calibrators provide the functionality and performance of regular industrial calibration devices.IS. In addition. 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. provides additional efficiency improvements with its seamless communication with calibration software. In view of safety. The product safety note lists all the “do’s and don’ts” for safe calibration. the calibrators provide performance and functionality. there are also some guidelines and constraints for how to use them in hazardous areas. it is the safest possible technique.
they must be IS-versions What are ATEX and IECEx? ATEX (“ATmosphères EXplosibles”. External pressure modules can be used with IS-calibrators. Making a calibrator safe and unable to cause ignition – typical technical differences: • Surface made of conductive material • Constraints in using the device (listed in Product Safety Note) • Small differences with electrical ranges (e. Companies in the EU where the risk of explosion is evident must also use the ATEX guidelines for protecting the employees. There are also usually small differences with electrical ranges compared to regular industrial calibrators (e. When charging the battery. but the Beamex intrinsically safe calibrators operate with chargeable batteries. IEC (International Electrotechnical Commission) is a nonprofit international standards organization that prepares and publishes international standards for electrical technologies.g. while maintaining the required level of safety. The objective of the IECEx Scheme is to facilitate international trade in equipment and services for use in explosive atmospheres. explosive atmospheres in French) is a standard set in the European Union for explosion protection in the industry. The surface of the device is made of conductive material. Many times intrinsically safe equipment operate only with dry batteries. 2003. quicker to discharge • Battery must be charged in a non-Ex area • When using external pressure modules. The battery of an intrinsically safe calibrator is usually slower to charge and it discharges quicker.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.g. it must be done in a non-Ex area. maximum is lower) • Battery slower to charge. 177
The differences in design and technical features were made with one purpose in mind – to ensure that the device is safe to use and is unable to cause an ignition. The IEC TC/31 technical committee deals with the standards related to equipment for explosive atmospheres. but they must also be intrinsically safe. 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. In addition.
. IECEx is an international scheme for certifying procedures for equipment designed for use in explosive atmospheres. maximum is lower). ATEX 95 equipment directive 94/9/EC concerns equipment intended for use in potentially explosive areas.
the MC5-IS replaces many individual measurement devices and calibrators.
The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. It is a documenting calibrator. The MC5-IS is also ATEX and IECEx certified. The best way to do this is to send it to the manufacturer or to an authorized service company for repair. 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 MC5-IS can also be used for calibrating Foundation Fieldbus H1 or Profibus PA transmitters. The MC5-IS also has HART communication. Being an all-in-one calibrator. electrical and frequency signals. all-in-one calibrator for extreme environments. The MC5-IS has calibration capabilities for pressure. Safe fieldbus calibration with the Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator The Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is a high accuracy. The most important thing to remember is that an intrinsically safe calibrator must maintain its intrinsic safety after the service or repair. which means that it communicates seamlessly with calibration software. Using documenting calibrators with calibration software can remarkably improve the efficiency and quality of the entire calibration process. The MC5-IS also has HART communication. Is service different for intrinsically safe calibrators? There are certain aspects that need special attention when doing service or repair on an intrinsically safe calibrator.the safest way to calibrate fieldbus instruments
As Beamex® MC5-IS Intrinsically Safe Multifunction Calibrator is certified according to ATEX and the IECEx Scheme. Recalibration can be done by calibration laboratories (still preferably with ISO/IEC 17025 accreditation).
its definition from a common grammar dictionary should never be used in work where the technical standard can apply. so everyone in the business knows what it is. In technical. journals. It is a supplement to the VIM. as well as publications of relevant technical and professional organizations. However. not to standardize the way the words should be used. Bucher. Those documents give the intended meaning of the word. The technical definitions may be different from the definitions published in common grammar dictionaries. GUM. If a word is defined in a technical standard. In some cases several may be merged to better clarify the meaning or adapt the wording to common metrology usage.appendix: calibration terminology a to z
Calibration terminology A to Z
his glossary is a quick reference to the meaning of common terms. NCSL Glossary. the purpose of common dictionaries is to record the ways that people actually use words. scientific and engineering work (such as metrology) it is important to correctly use words that have a technical meaning. Definitions of these words are in relevant national. international and industry standards. and the information in the other references listed at the end. Many of these definitions are adapted from the references. The Metrology Handbook.
. 2004. In technical work. Milwaukee: ASQ Quality Press.
______________ 1. and other publications. Jay L. only the technical definitions should be used.
2nd ed. The certificate. accuracy of a measurement is always
. Guide to the expression of uncertainty in measurement (called the GUM). IUPAP. 1993. U. ANSI/NCSL Z540-2-1997. NCSL. ANSI/NCSL. but should be considered an addition to the references listed above.appendix: calibration terminology a to z
Terms that are not in this glossary may be found in one of these primary references: 1. Accreditation criteria – Set of requirements used by an accrediting body that a laboratory must meet in order to be accredited. ISO. IEC. and OIML. Accreditation includes evaluation of both the quality management system and the competence to perform the measurements listed in the scope. not a replacement of them. 1999.)
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.5) Because the true value is always unknown. International vocabulary of basic and general terms in metrology (called the VIM). 3. 1997. NCSL Glossary of metrology-related terms. Accreditation body – An organization that conducts laboratory accreditation evaluations in conformance to ISO Guide 58. 2. S. serves as proof of accredited status for the time period listed. 3. (It is assumed that a calibration or metrology activity owns copies of these as part of its basic reference material. Some terms may be listed in this glossary in order to expand on the definition. Accreditation certificate – Document issued by an accreditation body to a laboratory that has met the conditions and criteria for accreditation. CO: NCSL International. BIPM. (VIM. Boulder. ISO. 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. IFCC. Geneva: ISO. with the documented measurement parameters and their best uncertainties. Boulder. An accreditation certificate without the documented parameters is incomplete. CO: NCSL International. IUPAC.
25) The value and direction of the bias is determined by calibration and/or gage R&R studies.11 and NCSL pages 4–5 for primary and secondary definitions. which is always the negative of the bias. (VIM. It is the process of verifying the capability and performance of an item of measuring and test equipment by comparison to traceable measurement standards. realize.) Calibration is a term that has many different – but similar – definitions. or when performing more-or-less routine calibrations of nearly ideal measuring instruments designed for the measurement of that quantity. (See VIM 6. 5. conserve. See also: correction. Calibration is performed with the item being calibrated in
. the best measurement capability for a particular quantity is “the smallest uncertainty of measurement a laboratory can achieve within its scope of accreditation when performing more or less routine calibrations of nearly ideal measurement standards intended to define. It has quantitative value only when accompanied by information about the uncertainty of the measuring system.” (EA-4/02) The best measurement capability is based on evaluations of actual measurements using generally accepted methods of evaluating measurement uncertainty. Adding a correction.appendix: calibration terminology a to z
an estimate.18) Accuracy is a design specification and may be verified during calibration. 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. systematic error Calibration – (1). 5. compensates for the bias. Bespoke/Customized computerised system – A computerised system individually designed to suit a specific business process Best measurement capability – For an accredited laboratory. 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. An accuracy statement by itself has no meaning other than as an indicator of quality. (VIM. or reproduce a unit of that quantity or one or more of its values. Bias – Bias is the known systematic error of a measuring instrument.
or artifacts as needed to verify the performance. report. The calibration process consists of comparing an IM&TE unit with specified tolerances. See also: performance test. or lamps. • The calibration process may include. Notes: • A requirement for calibration does not imply that the item being calibrated can or should be adjusted. or minimize by adjustment any deviations from the tolerance limits or any other variation in the accuracy of the instrument being compared. but of unverified accuracy. The result of a calibration is a determination of the performance quality of the instrument with respect to the desired specifications. Calibration is performed according to a specified documented calibration procedure. under a set of specified and controlled measurement conditions. 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. calculation of correction factors or adjustment of the instrument being compared to reduce the magnitude of the inaccuracy. and with a specified and controlled measurement system. fuses. or the determination of one or more corrections. 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. Calibration provides assurance that the instrument is capable of making measurements to its performance specification when it is correctly used. • Calibration does not include any maintenance or repair actions except as just noted. may be included as part of the calibration. The calibration process uses traceable external stimuli. or is otherwise in an indeterminate state.
. measurement standards. • In some cases. to a measurement system or device of specified capability and known uncertainty in order to detect. or minor adjustment such as zero and span. if necessary. This may be in the form of a pass/fail decision. minor repair such as replacement of batteries. determining or assigning one or more values.appendix: calibration terminology a to z
its normal operating configuration – as the normal operator would use it.
A laboratory database certificate is a record that cannot be changed. or an industry-specific name. It may be external or internal. calibration means the same as alignment or adjustment. IM&TE instruction manuals may use calibration to describe tasks normally performed by the operator of a measurement system. When used this way. 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. (B) In many cases. The certificate identifies the item calibrated. specifications.appendix: calibration terminology a to z
is known to be out of tolerance. or any combination or variation of these. including subsidiary operations of a larger entity. (2) In a laboratory database program. or tolerances for a model of measuring or testing equipment. or after it is repaired. These and similar tasks are excluded from the metrological definition of calibration. Contrast with: calibration (1) See also: normalization. standardization Calibration activity or provider – A laboratory or facility – including personnel – that perform calibrations in an established location or at customer location(s). It may be called a calibration laboratory. if it is amended later a new certificate is created. the intent is that they are part of the normal work done by a trained user of the system. or department. which are repair activities and excluded from the metrological definition of calibration. Calibration certificate – (1) A calibration certificate is generally a document that states that a specific item was calibrated by an organization. self-calibration. a means to record
. and the effective date. the organization presenting the certificate. a certificate often refers to the permanent record of the final result of a calibration. shop. It provides a list of recommended calibration standards to use for the calibration. A calibration procedure documents one method of verifying the actual performance of the item being calibrated against its performance specifications. a metrology laboratory or department. A calibration certificate should provide other information to allow the user to judge the adequacy and quality of the calibration. When calibration is used to refer to tasks like this. Examples include performing a selftest as part of normal operation or performing a self-calibration (normalizing) a measurement system before use.
clearly indicates tampering. See also: calibration certificate Calibration seal – A calibration seal is a device. 6. and test and measuring equipment (IM&TE). 6. a calibration report includes details of the methods and standards used. Note: A calibration seal may also be referred to as a tamper seal. In addition to the basic items of a calibration certificate. placard. standard reference material. Note: A calibration procedure does not include any maintenance or repair actions. Designation as a
.13.” A calibration seal provides a means of deterring the user from tampering with any adjustment point that can affect the calibration of an instrument and detecting an attempt to access controls that can affect the calibration of an instrument. A calibration program may also be called a measurement management system (ISO 10012:2003). A calibration seal is usually imprinted with a legend similar to “Calibration Void if Broken or Removed” or “Calibration Seal – Do Not Break or Remove. and 6. or measurement transfer standard that is designated as being used only to perform calibrations of other IM&TE items. The purpose of a calibration seal is to ensure the integrity of the calibration. Calibration standard – (See VIM. and the process of calibrating IM&TE used to determine conformance to requirements or used in supporting activities. and the actual measurement results and uncertainty. 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 procedure always starts with the assumption that the unit under test is in good working order and only needs to have its performance verified. Calibration standards generally have lower uncertainty and better resolution than general-purpose items. and by virtue of its design and material. As calibration standards are used to calibrate other IM&TE items. the parameters checked.14. artifact. and NCSL pages 36–38.9. or label that.appendix: calibration terminology a to z
quantitative performance data both before and after adjustments. they are more closely controlled and characterized than the workload items they are used for.) A calibration standard is an IM&TE item.1 through 6. when removed or tampered with. Calibration report – A calibration report is a document that provides details of the calibration of an item. and information sufficient to determine if the unit being calibrated is operating within the necessary performance specifications.
It is equal to the positive square root of a sum of terms. one might be designated as a calibration standard while the others are all general purpose IM&TE items. in a group of identical instruments. 2. the confidence interval is:
p (1 – p) s CI = x ¯ ± t = ––– or CI = p ± ––––––––– n n
where CI is the confidence interval. Calibration standards are often called measurement standards. The confidence interval is calculated from sample statistics. For example. standard deviations. and so on. Note: The word qualification is sometimes used in the personal sense. not on any other consideration. slopes. For a person. p is the proportion of items of a given type in the population. See also: standard (measurement) Combined standard uncertainty – The standard uncertainty of the result of a measurement. n is the number of items in the sample. whose fitness for use is demonstrated by a broad spectrum of users. (GUM. Competence – For a laboratory.
. however. the demonstrated ability to perform the tests or calibrations within the accreditation scope and to meet other criteria established by the accreditation body. For an infinite (or very large compared to the sample) population. 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.3.4) See also: expanded uncertainty Commercial of the shelf software – Software commercially available. and t is the Student’s T value for α ⁄2 and (n – 1) (α is the level of significance).appendix: calibration terminology a to z
calibration standard is based on the use of the specific instrument. The terms are the variances or covariances of these other quantities. x is the sample mean. the demonstrated ability to apply knowledge and skills. when that result is obtained from the values of a number of other quantities. s is the sample standard deviation. lines. Confidence intervals can be calculated for points. weighted according to how the measurement result varies with changes in those quantities. since it is a synonym and has more accepted usage in the United States.
It is usually given the value 2. (GUM. it is always an estimate. error or systematic error. Compare with: preventive action Coverage factor – A numerical factor used as a multiplier of the combined standard uncertainty in order to obtain an expanded uncertainty.14. See also: bias. sometimes referred to as a nonconformance.appendix: calibration terminology a to z
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. and NCSL pages 11–13. Error (of measurement) – (See VIM. 3. random error. 2. which approximately corresponds to a probability of 95 percent for degrees of freedom > 10’. error (or measurement error) is an estimate of the difference between the measured value and the probable true value of the object of the measurement.10. (VIM. including actions taken to prevent reoccurrence of the nonconformance. Equivalence – (A) Acceptance of the competence of other national metrology institutes (NMI). 3. which
. accreditation body. See also: bias. Error may be systematic and/or random. 3. Deficiency – Nonfulfillment of conditions and/or criteria for accreditation. and/or accredited organizations in other countries as being essentially equal to the NMI.) In metrology. Departure value – A term used by a few calibration laboratories to refer to bias. The error can never be known exactly. for a particular application.6) The coverage factor is identified by the symbol k. accreditation bodies.12–3. documented determination that a specific instrument or type of instrument is suitable for use in place of the one originally listed. (B) A formal. Systematic error (also known as bias) may be corrected. The correction value is equal to the negative of the bias. An example is the value calculated to compensate for the calibration difference of a reference thermometer or for the calibrated offset voltage of a thermocouple reference junction. systematic error Gage R&R – Gage repeatability and reproducibility study.15) Any residual amount is treated as random error. and/or accredited organizations within the host country. systematic error Corrective action – Corrective action is something done to correct a nonconformance when it arises. random error. correction (of error). The exact meaning can usually be determined from examination of the calibration certificate.3. error.
or SPETE (special purpose electronic test equipment). measuring. The number of instruments. TMDE (test. personnel. and length of time are established to be statistically valid consistent with the size and level of activity of the organization. PMET (precision measuring equipment and tooling). and evaluation of tests or calibrations on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions. Guide to the Expression of Uncertainty in Measurement. The data captured are analyzed statistically to obtain best measurement capability. 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. U. or after a process. GUM – An acronym commonly used to identify the ISO Guide to the Expression of Uncertainty in Measurement. and so on) where a tolerance is not specified and the indication is not critical to safety. S. during. Some organizations do not include instruments used solely to check for the presence or absence of a condition (such as voltage. personnel. so it is a first-party audit. pressure. International Organization for Standardization (ISO) – An international nongovernmental organization chartered by the United Nations in 1947. and test equipment. the equivalent document is ANSI/NCSL Z540-2-1997. PME (precision measuring equipment). which is expressed as an uncertainty with a coverage factor of k = 2 to approximate 95 percent.appendix: calibration terminology a to z
(typically) employs numerous instruments. with headquarters in Geneva. GPETE (general purpose electronic test equipment). and diagnostic equipment). The mission of ISO is “to promote the development of standardization and
. Switzerland. performance. Interlaboratory comparison – Organization. and measurements over a period of time to capture quantitative observations. measurements. This term includes all items that fall under a calibration or measurement management program. measuring. IM&TE – The acronym IM&TE refers to inspection. IM&TE items are typically used in applications where the measurement results are used to determine conformance to technical or quality requirements before. In the United States. An internal audit is done by or on behalf of the laboratory itself. Note: Organizations may refer to IM&TE items as MTE (measuring and testing equipment).
periodic. Effectively. 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. thermodynamic temperature. the coverage level expressed as a percent. industry and commerce except electrical and electronic engineering. Measurement – A set of operations performed for the purpose of determining the value of a quantity. testing. specification. electric current. and luminous intensity. time. so it will be a constant in all languages. (The acronym SI is from the French Systéme International.) The name also symbolizes the mission of the organization – to equalize standards worldwide. Life cycle – All phases in the life of the system from initial requirements until retirement including design. In this context. Level of confidence – Defines an interval about the measurement result that encompasses a large fraction p of the probability distribution characterized by that result and its combined standard uncertainty. and p is the coverage probability or level of confidence of the interval. (If the acronym was based on the full name were used. amount of substance.appendix: calibration terminology a to z
related activities in the world with a view to facilitating the international exchange of goods and services. it would be different in each language. ISO – Iso is a Greek word root meaning equal. The International Organization for Standardization chose the word as the short form of the name.) SI units are defined and maintained by the International Bureau of Weights and Measures (BIPM) in Paris. operation.1)
. formal.” The scope of ISO’s work covers all fields of business. programming. Management review – The planned. IT Infrastructure – The hardware and software such as networking software and operation systems. which makes it possible for the application to function. technological and economic activity. length. installation. (Mass.) SI is international system of measurement for all physical quantities. The SI system is popularly known as the metric system. The members of ISO are the designated national standards bodies of each country. and to developing cooperation in the spheres of intellectual. 2. scientific. France. ISO is not an acronym.) See also: ISO International System of Units (SI) – A defined and coherent system of units adopted and used by international treaties. (VIM. and maintenance. (The United States is represented by ANSI.
associated materials and accessories. people. whose membership is open to any organization with an interest in the science of measurement and its application in research. and the base of natural logarithms (e). vehicle. Any value other than zero is an offset created by inhomogeneity of the thermocouple wires combined
. the procedures used. home. and other quantifiable factors that combine to determine the success of a measurement process.16 K). the ratio of a circle’s circumference to its diameter (p). the quantum charge ratio (h/e). Mobile operations may include work from an office space. Natural constants are used in the basic theoretical descriptions of the universe. scientific. NCSL international – Formerly known as the National Conference of Standards Laboratories (NCSL). The measurement system includes at least the test and measuring instruments and devices.” Normalization. For example. Metrolog y – Metrology is the science and practice of measurement (VIM. if the thermocouple alloy leads of a reference junction probe are formed into a measurement junction and placed in an ice point cell. conditions. methods. 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. Examples of natural physical constants important in metrology are the speed of light in a vacuum (c). and the physical environment. or commerce. commercial and government facilities around the world. NCSL was formed in 1961 to “promote cooperative efforts for solving the common problems faced by measurement laboratories. Mobile operations – Operations that are independent of an established calibration laboratory facility. 2. education. NCSL has member organizations from academic. then the theoretical thermoelectric emf measured at the copper wires should be zero. measurement standards. industrial. or the use of a virtual office. the gravitational constant (G).2). development. and the reference junction itself is also in the ice point. instrument calibration. the personnel. Natural (physical) constant – A natural constant is a fundamental value that is accepted by the scientific community as valid. NCSL is a nonprofit organization. NCSL promotes technical and managerial excellence in the field of metrology. and test and measurement. the triple point of water (273.appendix: calibration terminology a to z
Measurement system – A measurement system is the set of equipment.
Policy statements relevant to the quality management system are generally stated in the quality manual. A performance test is the same as a calibration (1). but actually perform the calibration actions at customer locations.
. Policies can also be in the organization’s policy/procedure manual. Precision is a measure of the repeatability of a measuring system – how much agreement there is within a group of repeated measurements of the same quantity under the same conditions. Some policies may be implemented by fairly detailed procedures. There may be more than one procedure for a given policy. Calibration: see calibration procedure. This includes climate-controlled mobile laboratories. Contrast with: corrective action Procedure – A procedure describes a specific process for implementing all or a portion of a policy. See also: calibration (1) Policy – A policy defines and sets out the basic objectives. Compare with: bias. See also: procedure Precision – Precision is a property of a measuring system or instrument. See also: policy Process owner – The person responsible for the business process.appendix: calibration terminology a to z
with other uncertainties. while others may only have a few general guidelines. 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. goals. or general management position on a specific topic.5) Preventive action – Preventive action is something done to prevent the possible future occurrence of a nonconformance. A procedure has more detail than a policy but less detail than a work instruction. even though such an event has not yet happened. Preventive action helps improve the system. vision. error On-site operations – Operations that are based in or directly supported by an established calibration laboratory facility. (NCSL. (VIM. A policy describes what management intends to have done regarding a given portion of business activity. 3. Performance Test – A performance test (or performance verification) is the activity of verifying the performance of an item of measuring and test equipment to provide assurance that the instrument is capable of making correct measurements when it is properly used. A performance test is done with the item in its normal operating configuration. page 26) Precision is not the same as accuracy.
or has covers removed.13) Random error causes scatter in the results of a sequence of readings and. Passing the calibration test indicates success of the repair. The need for repair may be indicated by the results of a calibration. See also: error Compare with: systematic error Repair – Repair is the process of returning an unserviceable or nonconforming item to serviceable condition. 3. or replacing one or two in-stock components. auditors use the quality manual when they audit the quality management system. work instructions. Random error – Random error is the result of a single measurement of a value. Contrast with: calibration (1). or proprietary information. repair is always followed by calibration of the item. Passing
. 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. Random error is usually evaluated by Type A methods. In addition to its regular use by the organization. Repair includes adjustment or alignment of the item as well as component-level repair. or lamps. (Some minor adjustment such as zero and span may be included as part of the calibration. or minor cleaning of switch contacts. minus the mean of a large number of measurements of the same value. is a measure of dispersion. or repairing a broken wire. therefore. or is removed from its case and may be disassembled to some degree. fuses. repair (minor) Repair (minor) – Minor repair is the process of quickly and economically returning an unserviceable item to serviceable condition by doing simple work using parts that are in stock in the calibration lab.appendix: calibration terminology a to z
Proficiency testing – Determination of laboratory testing performance by means of interlaboratory comparisons. (VIM. Quality manual – The quality manual is the document that describes the quality management policy of an organization with respect to a specified conformance standard. For calibratable items. it does not usually contain any detailed policies and never contains any procedures. the GUM specifically does not replace random error with either Type A or Type B methods of evaluation. The quality manual is generally provided to customers on request. Examples include replacement of batteries. minor repair is always followed by calibration of the item.) The need for repair may be indicated by the results of a calibration. The instrument is opened. Note: Contrary to popular belief. For calibratable items. Therefore. but Type B methods are also used in some situations.
The reported value is the difference between the nominal value and the mean of a number of repeat measurements. parameters. or if the ambient temperature changes by a specified
. Round robin – See: Interlaboratory Comparison Scope of accreditation – For an accredited calibration or testing laboratory. or calibrations and their best measurement. The reported value is usually the mean of a number of repeat measurements. the scope is a documented list of calibration or testing fields. The uncertainty of the deviation is usually expanded uncertainty as defined in the GUM. repair Reported value – One or more numerical results of a calibration process. as recorded on a calibration report or certificate. • Estimated systematic error and uncertainty. uncertainty. 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. most reported values will be in one of these formats: • Measurement result and uncertainty. or week of continuous operation. Contrast with: calibration (1). The specific type and format vary according to the type of measurement being made. or once per shift. with the associated measurement uncertainty. and only the listed areas may be offered as accredited calibrations or tests. and where no parts have to be ordered from external suppliers. In general. The scope document is an attachment to the certificate of accreditation and the certificate is incomplete without it. The process may be required at intervals such as every power-on sequence. The accreditation body usually defines the format and other details. day. specific measurements.appendix: calibration terminology a to z
the calibration test indicates success of the repair. Minor repairs are defined as repairs that take no longer than a short time as defined by laboratory management. and where substantial disassembly of the instrument is not required. The uncertainty is usually expanded uncertainty as defined in the GUM. 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. Only the calibration or testing areas that the laboratory is accredited for are listed in the scope document. • Deviation from the nominal (or reference) value and uncertainty.
a specification is a documented statement of the expected performance capabilities of a large group of substantially identical measuring instruments. The usual purpose is accuracy enhancement by characterization of errors inherent in the measurement system before the item to be measured is connected. if an instrument requires self-calibration before use.B) Contrast with: calibration (1) Specification – In metrology.appendix: calibration terminology a to z
amount. 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. government. the process may be performed totally by the instrument or may require user intervention and/or use of external calibrated artifacts. A product that performs outside the specification limits when tested (calibrated) is rejected for later adjustment. given in terms of the relevant parameters and including the accuracy or uncertainty. laboratory standard. Measurement standards are generally used in calibration laboratories. Selfcalibration may also be called normalization or standardization. Standard (document) – A standard (industry. calibration standard. instrument. artifact. then that will also be accomplished at the start of a calibration procedure. An example is ANSI/NCSL Z540-11994. national. or material that is used as a defined basis for making quantitative measurements. Accepted as having the highest metrological
. Once initiated. 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. an étalon) is a system. Customers use specifications to determine the suitability of a product for their own applications. or scrapping. repair. Also. 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. Compare with: calibration (2. Items with similar uses in a production shop are generally regarded as working-level instruments by the calibration program. Primary standard. or the methods for evaluation of any of these. Standard (measurement) – A standard (measurement standard. 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. reference standard. device. or international standard.
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. Working standard. Systematic error is a measure of magnitude and may be corrected. Systematic error may be evaluated by Type A or Type B methods.1) Standardization – See: self-calibration. expressed as a standard deviation. Examples: triple point of water cell and caesium beam frequency standard. Also called a reference standard. The highest accuracy level standards in a particular laboratory generally used only to calibrate working standards. (VIM.” Standard uncertainty – The uncertainty of the result of a measurement. The highest level standards. (3.14) Systematic error causes the average of the readings to be offset from the true value. Systematic error is also called bias when it applies to a measuring instrument. See also: calibration standard Standard operating procedure (SOP) – A term used by some organizations to identify policies. Transfer standard.3. 3. are the realizations or representations of SI units. Note: Contrary to popular belief. error. 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. 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. SRMs represent one of the primary vehicles for disseminating measurement technology to industry. A standard that is used for routine calibration of IM&TE. Secondary standard. found in national and international metrology laboratories. A device used to transfer the value of a measurement quantity (including the associated uncertainty) from a higher level to a lower level standard. (GUM.2. 2.3. note) See also: bias. procedures. or work instructions. the GUM specifically does not replace systematic error with either Type A or Type B methods of evaluation. and is accompanied by. or traceable to.appendix: calibration terminology a to z
qualities and whose value is accepted without reference to other standards of the same quantity. correction (of error) Compare with: random error
. according to the type of data available.
Test accuracy ratio – (1) In a calibration procedure. A tolerance is a property of the item being measured. (NCSL. percentage. If the accuracy tolerances are expressed as decibels. and maintenance of a computerised system and for the security of the data residing on that system. 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. uncertainty
. 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
System owner – The person responsible for the availability. they must be converted to absolute values of the basic measurement units. they must be converted to absolute values of the basic measurement units. it represents the maximum allowable deviation from a specified value. page 2) TUR = UUT_tolerance STD_uncert The TUR must be calculated using identical parameters and units for the UUC and the calibration standard. Test uncertainty ratio – In a calibration procedure. 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. (NCSL. Note: TAR may also be referred to as the accuracy ratio or (incorrectly) the uncertainty ratio. page 2) TAR = UUT_tolerance STD_tolerance The TAR must be calculated using identical parameters and units for the UUC and the calibration standard. or another ratio. (2) In the normal use of IM&TE items. If the accuracy tolerances are expressed as decibels. Tolerances are applied during design and manufacturing. or another ratio. percentage. 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. Note: The uncertainty of a measurement standard is not necessarily the same as its accuracy specification.
fundamental or physical natural constants that are reproducible and have defined values. Measurement assurance methods applied to a calibration system include demonstration of traceability. That number is merely a catalog number of the specific service provided by NIST to a customer so it can be identified on a purchase order.10) Traceability is a demonstrated or implied property of the result of a measurement to be consistent with an accepted standard within specified limits of uncertainty. or any other thing is not and be traceable to a national standard. 6. a measurement system.appendix: calibration terminology a to z
Traceable. Traceability provides the ability to demonstrate the accuracy of a measurement result in terms of the stated reference. provided all of the conditions just listed are met. 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. Only the result of a specific measurement can be said to be traceable. (NCSL. through an unbroken chain of comparisons each having stated uncertainties. from a primary standard to a secondary standard. traceability – Traceability is a property of the result of a measurement. Examples of typical transfer standards are DC volt sources (standard cells or zener sources). or from a secondary standard to a working standard in order to create or maintain measurement traceability. Reference to a NIST test number is specifically not evidence of traceability. The laboratory must also apply and use the data. A calibration system operating under a program controls system only implies traceability. Common transfer methods are differential measurements and ratio measurements. but the report alone is not sufficient. A calibration laboratory. 6. a calibration report. providing the ability to relate the measurement result to stated references. a calibrated IM&TE. or inductors. ratio type comparisons. certified standard reference materials. (VIM. 198
. Evidence of traceability includes the calibration report (with values and uncertainty) of calibration standards. pages 42–43) The stated references are normally the base or supplemental SI units as maintained by a national metrology institute.8) Typical applications of transfer standards are to transfer a measurement parameter from one organization to another. or industry or other accepted consensus reference standards. capacitors. (VIM. and singlevalue standard resistors. Transfer standard – A transfer standard is a measurement standard used as an intermediate device when comparing two other standards.
3. with a specified level of confidence. categorized by type of measurement. methods. VIM – An acronym commonly used to identify the ISO International
. (GUM.3. range of measurement. Uncertainty is an estimate of dispersion. Uncertainty – Uncertainty is a property of a measurement result that defines the range of probable values of the measurand.3.5) Data for evaluation by Type B methods may come from any source believed to be valid.3 through 3.2. which are used in the text of the calibration procedure for convenience.3. 2. 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.5) Uncertainty can only be evaluated by Type A methods if the laboratory actually collects the data. effects that contribute to the dispersion may be random or systematic. Verification – Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Also may be called device under test (DUT) or equipment under test (EUT). (GUM. Type B evaluation (of uncertainty) – Type B evaluation of measurement uncertainty includes any method except statistical analysis of actual measurement results.appendix: calibration terminology a to z
Type A evaluation (of uncertainty) – Type A evaluation of measurement uncertainty is the statistical analysis of actual measurement results to produce uncertainty values. (GUM. Type B evaluation Uncertainty budget – The systematic description of known uncertainties relevant to specific measurements or types of measurements.3 through 3. and/or procedures are fit for their intended use. These are standard generic labels for the IM&TE item that is being calibrated. Both random and systematic error may be evaluated by Type B methods.3. See also: Type A evaluation. the result is a value with a calculated uncertainty. UUT – The unit under calibration or the unit under test – the instrument being calibrated. Both random and systematic error may be evaluated by Type A methods. After an item that has a specified tolerance has been calibrated using an instrument with a known accuracy. Validation – Substantiation by examination and provision of objective evidence that verified processes.3) Uncertainty is an estimate of the range of values that the true value of the measurement is within. UUC. 3. and/ or other applicable measurement criteria.
) Work Instruction – In a quality management system. Milwaukee: ASQ Quality Press. Bucher.appendix: calibration terminology a to z
Vocabulary of Basic and General Terms in Metrology. a calibration procedure is a type of work instruction. Work instructions are used only where they are needed to ensure the quality of the product or service. The level of education and training of the people with the usual qualifications to do the work must be considered when writing a work instruction. The Metrology Handbook. (The acronym comes from the French title. a work instruction defines the detailed steps necessary to carry out a procedure. 2004. In a metrology laboratory.
. Jay L.
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