WINTER 2020/21 NEWSLETTER HIGHLIGHTS ISO/IEC 17025:2017 TRANSITION END OF BREXIT TRANSITION WHY THE MEASUREMENT INFRASTRUCTURE IS VITAL IN ECONOMIC RECOVERY FROM COVID-19CONTENTS Page 2 – Editor’s Note Page 3 – Meet our Newlsetter Contributors Page 4 – News Page 6 – Compendium of Examples of Measurement Uncertainty Evaluation By Professor Maurice Cox, NPL Senior Fellow, Data Science Department, NPL Page 7 – ISO/IEC 17025:2017 Transition Update By Paul Greenwood, Operations Director, UKAS Page 8 – ISO/IEC 17025:2017 Ensuring the Validity of Results – Are These New Requirements? By Trevor Thompson, bestmeasurement.com Page 10 – End of Brexit Transition – An Accreditation Perspective By Paul Greenwood, Operations Director, UKAS Page 12 – EU FTA Transition (UKCA) By Terence Boniface, Assistant Director, Advanced Manufacturing Department for Business, Energy and Industrial Strategy, UKCA Page 14 – Conformity Assessment Post Brexit – Placing New Manufactured Products on the Market in The UK, Northern Ireland and the EU after 1 January 2021 by Jeff Llewellyn, President BMTA, and non-Executive Director, UKAS Page 16 – Automated Calibration of Non-Automated Devices By Matt Gypps, UK Technical Manager, Trescal Page 18 – Making Regulatory Chemical Emissions Tests Easier For Construction Products Manufacturers By Elinor Hughes, Technical Copywriter, Markes International Page 22 – Why Is The Measurement Infrastructure Vital In Economic Recovery From Covid-19? by Dr Richard Brown, Head of Metrology, NPL Page 24 – Company Profile - 3M Welcome readers to the Winter issue of the BMTA Newsletter It’s been a very busy time for our members over the past few months. The end of the year meant that Brexit transition was completed and that we are now no longer a member of the EU. Combined with the Testing, Measurement and Calibration industry being at the forefront of the Covid-19 issue, this has meant many of our members have been busier than ever. As such, this issue is filled with articles and features on those subject matters. We look at the ISO/IEC 17025:2017 transition; the end of the Brexit transition from an accreditation perspective; conformity assessment post Brexit; and why the measurement infrastructure is so vital in the economic recovery from Covid-19. Looking forward to our Spring issue, our focus theme is based on: • Agile practices in standards, testing, measurement and calibration To help us provide our BMTA members with useful information we would like your help to: > identify and share relevant topics > provide research on new technologies or techniques > let us know industry news > promote events and training sessions > inform us of publications you think may be of interest to your fellow BMTA members. If you would like to contribute to the next issue of the BMTA Newsletter please contact editor.bmta@abacus-comms. co.uk with a brief synopsis. Equally, should your business produce any information, white papers or interviews that you would like to share, please submit this to enquiries@bmta.co.uk. To subscribe visit: www.bmta.co.uk. EDITOR’S NOTE bmta.co.uk 2MEET OUR NEWSLETTER CONTRIBUTORS bmta.co.uk Professor Maurice Cox NPL Senior Fellow Data Science Department National Physical Laboratory Matt Gypps, UK Technical Manager, Trescal Dr Richard Brown, Head of Metrology, NPL Trevor Thompson, bestmeasurement.com Paul Greenwood, Divisional Director (Laboratories), UKAS Paul Greenwood (CChem MRSC) joined UKAS in 2006 after a 13 year post-graduate career as a chemist in the fields of drinking water analysis, environmental testing and analytical instrument manufacture. In addition to oversight of the accreditation of around 1500 laboratories he is a member of the UKAS Executive and responsible for ensuring strategic development and delivery of accreditation nationally and internationally. Maurice Cox is an Emeritus Senior Fellow in Mathematics and Scientific Computing. Dr Maurice Cox received a BSc in Applied Mathematics from City University, London, and a PhD in Numerical Analysis (spline functions) also from City University. He is consultant to NPL where he is particularly concerned with generic approaches to the evaluation of measurement uncertainty and methods for the evaluation of interlaboratory comparison data. Maurice has made major contributions to Supplements to the Guide to the expression of uncertainty in measurement (GUM) and other related guides through his membership of the Joint Committee for Guides in Metrology (JCGM). Matt and his team are responsible for maintaining and developing all technical services, plus monitoring and improving their capability. He started his career as a calibration and repair apprentice nearly 30 years ago. He has professional qualifications in H&S and management as well as Electronic engineering. Dr Richard Brown is an NPL Fellow in Chemical Metrology. He received his BSc in Chemistry (together with the Governors’ Prize for Chemistry) and his PhD in Electrochemistry from Imperial College, London. Since then he has worked for NPL. In March 2018, Richard was appointed as the inaugural Head of Metrology at NPL, with accountability for ensuring the quality of NPL’s scientific research and measurement service work. Trevor is an experienced metrologist, technical manager, and an enthusiastic advocate of quality management in metrology. He served at NPL and then was a founding member of The NATLAS Executive (The UK’s first national government inspired testing laboratory accreditation scheme). Trevor conducted many assessments of conformity assessment bodies against documented requirements over 30 years. He then managed the physics and electrical laboratory accreditation at The United Kingdom Accreditation Service, UKAS, for many years and represented UKAS Laboratory Accreditation in Europe’s EA. As Decision Maker for most 17000 series standards he moderated and approved the assessments undertaken and conformity decisions. Terence Boniface Asst Director, Advanced Manufacturing Department for Business, Energy & Industrial Strategy Elinor Hughes, technical copywriter, Markes International, Gwaun Elai Medi-Science Campus, Llantrisant, UK Elinor Hughes obtained her B.Sc. in chemistry and Ph.D. in organic chemistry at Bangor University. After working for a chemical manufacturing company for three years, she moved to the Royal Society of Chemistry where she worked in journals publishing for six years and on Chemistry World magazine for four years, followed by five years as a freelance copyeditor and science writer. Dr Jeff Llewellyn, President, BMTA A Chemist by Profession, graduating from Swansea, Jeff obtained his PhD in Carbohydrate Chemistry in 1972. After wo years post- doctoral research, he joined the Laboratory of the Government Chemist (now LGC) in 1973 where he worked for 10 years in food and environmental analysis. Jeff moved to the Department of the Environment with responsibility for Indoor Air Quality and Asbestos in Buildings, later joining the Building Research Establishment (now BRE Ltd) where he managed the Organic Materials Division and later the Centre for Environment and Health. Jeff became Chief Executive of the National Weights and Measures Laboratory (NWML - now the National Measurement Office, NMO) in 2002, then an Executive Agency of DTI. He remained there until he retired from the Civil Service in August 2007. 34 NEWS bmta.co.uk Contribute to our next newsletter We encourage our readers to send in press releases, announcements and opinion pieces on a wide range of technical, operational and commercial issues impacting any aspect of the UK measurement and testing industry. To provide the best possible coverage for you within the newsletter we ask that alongside the article that you provide a 50-100 word synopsis which we can use to highlight the article before publication via news feeds and the BMTA website. Feature articles are usually between 600-1500 words in length. In addition to this we would ask that you provide supporting images, at print ready resolution, together with a photo and short biography of the author. If you would like to contribute, please email Laura Vallis at editor.bmta@abacus-comms.co.uk BMTA - the Voice of Measurement and Testing BMTA was created in 1990 in response to the need for an independent ‘lobby’ for the private sector to speak with one voice to Government, UKAS, BSI and other official bodies on issues affecting the whole measurement, testing and calibration community. We encourage you to make your views known in the standards making process, through your contribution to newsletters, participation in Association activities and membership of relevant BMTA and Standards Making committees. ILAC - IAF SINGLE ORGANISATION PROJECT The ILAC and IAF have announced the appointment of Dr.-Ing. Thomas Facklam Unternehmensberatung as the preferred contractor for the IAF-ILAC Single Organisation Project. Dr. Ing. Facklam is well known having been Chairman of IAF, a member of the EA Executive Committee, Chief Executive of DAkks. The Single Organisation Project was first approved at the 19th IAF- ILAC Joint General Assembly in October 2019. As yet no timeline for the project has been published or deadlines set. BSI CONFIRMED AS AN APPROVED BODY FOR UKCA MARKING BSI has been informed by the Department for Business, Energy and Industrial Strategy (BEIS) that it is an Approved Body (0086) for the UKCA marking. This new marking is required for placing relevant regulated products on the market in England, Scotland and Wales from 1 January 2021. BSI will also continue to be a Notified Body for the Northern Ireland market. The UKCA mark replaces CE marking in Great Britain (GB) countries, although CE marking will continue to be recognised for products being placed on the GB market that have been certified by an EU notified body until the end of December 2021. As an Approved Body, BSI can work with organisations on the required conformity assessment procedures that will allow them to affix the UKCA marking on to the following products: • Construction Products submitted to the Construction Products Regulation (CPR) • Personal Protective Equipment (PPE) • Gas appliances • Pressure Equipment • Lifts submitted to the Lift Directive • Marine equipment • Measuring instruments • Radio equipment Several organisations have already achieved the UKCA mark with BSI. The organisations certified by BSI can be viewed here in the BSI Verifeye directory. BSI will continue to offer CE marking services for EU27 market access via our Netherlands Notified Body (2797), as well as many other global market access solutions including our Mark of Trust, the BSI Kitemark. For further details please visit https://www.bsigroup.com/en-GB/our- services/product-certification/ukca-mark/ BMTA STRATEGY SUB-GROUP The BMTA Council have considered the strategic path for the BMTA and have formed a strategy sub-group to further the Association’s forward thinking direction of travel. BMTA is now looking for contributors to join the sub-group. If you would like to forward your ideas and thoughts as to what additional benefits the BMTA can offer our members please contact enquiries@bmta.co.uk.5 TEMPORARY MOVEMENT OF GOODS - VAT AND DUTY IMPLICATIONS In October HMRC issued Brief 15. This reaffirms the liability of VAT and Duty on goods moved temporarily to a non-owner for processing. For the test and measurement industry, this may mean you are unable to claim back VAT and will be liable for Duty if customers send goods to you for ‘repair’. Repair would include maintenance, testing and calibration. The VAT and Duty liability would be on the value of the goods and not the value of the repair and without special authorised customs procedures, you cannot claim these back or defer them. This may impact companies who have been used to free trade and temporary movement of goods within the EU. If you are not already authorised by HMRC for Inward Processing, you may need to take very swift action. Further details on this can be found at: https://www.gov.uk/government/publications/revenue-and-customs-brief-15-2020-vat-conclusion- of-review-of-import-vat-deducted-as-input-tax-by-non-owners/revenue-customs-brief-15-2020-vat- conclusion-of-review-of-import-vat-deducted-as-input-tax-by-non-owners UKAS REBRANDS AND LAUNCHES NEW WEBSITE UKAS has launched their new brand and website. The brand development process was initiated by customer feedback and heavily supported through stakeholder engagement via UKAS’ Policy Advisory Council (PAC). The renewed look is an important part of UKAS’ strategy and supports their expansion into new areas of accreditation and position in the testing, inspection and certification marketplace. To support the brand refresh, UKAS has also launched a new website. Information to support the launch; • www.ukas.com – explore the new layout and features. • Customer Area of new website - This area contains useful information for all UKAS customers, including application forms and marketing support. • Customer toolkit – learn more about the rebrand, the logos and the new symbols. • Brand FAQ’s. • New UKAS Symbols – refreshed UKAS symbols which can be seen in the toolkit. A symbols pack will be sent to you and you can refer to the conditions of use here. Please note the updated conditions will be published by BEIS imminently. • Transition period – UKAS appreciate that customers will need time to implement changes to the symbols. These are the pragmatic timeframes; • Digital Materials – 1 year from launch (1st February 2022) • Printed Materials – 2 years from launch (1st February 2023) • Certificates – 3 years from launch (1st February 2024) NEWS bmta.co.ukCOMPENDIUM OF EXAMPLES OF MEASUREMENT UNCERTAINTY EVALUATION By Professor Maurice Cox, NPL Senior Fellow, Data Science Department, NPL These examples illustrate the competent application of the “Guide to the expression of Uncertainty in Measurement” (GUM and its related documents) and also provide a view of the latest developments across Europe and elsewhere. The compendium currently contains some 20 examples (40 examples on completion) and four tutorials. The tutorials provide a quick entry to the use of the Monte Carlo method from GUM Supplement 1, the use of measurement models in a Bayesian framework, treating correlation (which many users find difficult), and reporting measurement uncertainty. Several examples demonstrate the guidance in these tutorials in specific applications. Apart from demonstrating the methods from the GUM suite of documents, several examples cover in depth the use of regression (least squares) for various purposes (such as method comparison and calibration of an instrument) and Bayesian methods of uncertainty evaluation. The examples using Bayesian methods show how they compare with methods currently covered by the GUM suite and also indicate the opportunities they offer to appreciate contextual data, such as prior knowledge on model parameters, instrument performance and the measurand. The examples cover considerably more than uncertainty associated with traditional calibration, reference material production and testing. As the complexity of the models used grows, so does the demand for better skills in uncertainty evaluation. The examples provide a wealth of study material to extend users’ skills by “learning by example” and set directions for the further development of the GUM suite. New JCGM document on developing and using measurement models The GUM suite of documents (Guide to the expression of Uncertainty in Measurement, its Supplements and related documents) has been extended by a document GUM-6 describing the development and use of measurement models in the evaluation of measurement uncertainty. The methods for evaluating measurement uncertainty in the GUM suite all presume the existence of a measurement model that relates the measurand to a set of input quantities. The development of these models is perceived by many as difficult, and previously little guidance was available. The new document takes the reader from the specification of the measurand through the steps needed to arrive at a complete measurement model, suitable for providing a value for the measurand and an associated uncertainty. An important stage in this process is the description of the measurement principle, as for many users of standardised test methods this principle is already described by a model. This ‘basic model’ nearly always needs extension to include effects arising from the measurement, such as calibration, corrections to be applied, repeatability and reproducibility. The document also introduces an important group of models, statistical models, to support the development of methods for the evaluation of data sets. bmta.co.uk 6 In the EURAMET project “Examples of Measurement Uncertainty Evaluation” (EMPIR 17NRM05), a compendium of novel and improved examples of measurement uncertainty evaluation has been developed.ISO/IEC 17025:2017 TRANSITION - UPDATE By Paul Greenwood, Operations Director, UKAS bmta.co.uk ISO/IEC 17025 is the most popular international reference standard for ensuring the competence of testing and calibration laboratories around the world. Producing valid results that are widely trusted is at the heart of laboratory activities. This standard allows laboratories to implement a sound quality system and demonstrate that they are technically competent and able to produce valid and reliable results. It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade. Updated The standard has been updated in order to reflect the latest changes in market conditions and technology; the new edition encompasses the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management. The scale of the revision was also clear to ILAC (the International Laboratory Accreditation Cooperation) and they agreed an implementation date of 30th November 2020 – three years from publication - to accommodate the large numbers of organisations needing to make the necessary changes to their processes and procedures in order to demonstrate conformity, and for accreditation bodies to then check their effective implementation. Covid-19 The current COVID-19 outbreak led to global restrictions on travel and social contact that has had a significant impact on the ability of some laboratories to implement the necessary changes, and for accreditation bodies to complete assessments and confirm compliance before the original November deadline. Recognising the difficulties faced, ILAC and ISO agreed that the deadline should be extended by six months to allow sufficient additional time for all transitions to be completed. As a consequence, a revised deadline of 1st June 2021 was agreed, and accreditation against ISO/IEC 17025: 2005 will continue to be recognised up until this date. The ISO/ ILAC ISO/IEC 17025:2017 Transition Communique has been updated to reflect the extension to the transition period. Accreditations In the UK, accreditation to ISO/IEC 17025 is conferred by the United Kingdom Accreditation Service (UKAS) and, at the time of the original announcement, there were 1603 such accreditations in place. UKAS has been working with accredited laboratories over the past three years to ensure that all were successfully transitioned before the original (November 2020) deadline. Progress towards that goal has been excellent and despite the significant challenges faced by UK testing and calibration laboratories from the COVID-19 pandemic and preparation for our withdrawal from the European Union, it is clear that there has been a tremendous national focus on meeting the amended requirements. As of 30th November 2020 - the date which was originally specified as the cut-off for transition to have been completed - 99% of accredited laboratories had been successfully converted to the latest version of the standard, leaving just 15 organisations yet to satisfy the amended requirements before the revised deadline of June 2021. UKAS continues to work proactively with these remaining laboratories and does not anticipate that there will be any that fail to meet the revised deadline given current progress. Commitment As a nation, we can be incredibly proud of the hard work that has been taking place in laboratories throughout the UK over the past three years to put us in such a strong position in terms of international conformity. We should recognise and celebrate the quiet resolve of our test houses and calibration laboratories that have dedicated valuable time and resources during such a difficult period to prove their ongoing commitment towards continual improvement and technical validity. This ultimately ensures that UK measurement and testing infrastructure remains at the leading edge at a time when it is most needed to support our move towards greater national independence. When ISO announced on December 1st 2017 that ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, had been updated, the conformity assessment community was aware that this would be one of the largest scale transitions of an accreditation standard ever undertaken. 7bmta.co.uk ISO/IEC 17025:2017 ENSURING THE VALIDITY OF RESULTS – ARE THESE NEW REQUIREMENTS? By Trevor Thompson, bestmeasurement.com Previous versions of ISO/IEC 17025 used different terminology but the concept that has existed for many years remains. If you consider that compliance arises from a) Technical Competence – the right people and equipment b) Consistency provided by a reliable management system and c) Actually getting a valid result demonstrably in practice then one needs to consider how to achieve the demonstration of validity that c) above requires. In the latest version of the standard, the use of the term “quality” has been replaced in several places by “validity”. This better reflects that measured values and test results all come with an uncertainty of measurement and if correct, the result is valid. This avoids confusing smaller and larger uncertainties with high and low quality of work. A further enhancement in this version of the Standard is to include an extensive list of possible activities that might be undertaken to ensure the validity of results. All laboratories should expect to find something appropriate and attractive to them in the list. This activity shall be undertaken, where appropriate, but not be limited to the items in Clause 7.7.1: a) use of reference materials or quality control materials; b) use of alternative instrumentation that has been calibrated to provide traceable results; c) functional check(s) of measuring and testing equipment; d) use of check or working standards with control charts, where applicable; e) intermediate checks on measuring equipment; f) replicate tests or calibrations using the same or different methods; g) retesting or recalibration of retained items; h) correlation of results for different characteristics of an item; i) review of reported results; j) intralaboratory comparisons; k) testing of blind samples It is not expected that all laboratories undertake all these activities. The list includes items particular to various types of laboratory activity and the laboratory should choose items that are relevant to them and which would bring the most useful information in their circumstances. Some of the suggestions overlap with each other in their application and usefulness. Most of these possibilities would usually be considered “internal” to the laboratory or to a group of laboratories having common features. There are distinct weaknesses arising from purely internal activity. If there was deficient traceability of measurement in a single external source, this might not be seen. Furthermore, any deficiency in the documented procedure for doing a test or calibration, followed by everyone would not be seen and the same might apply to bad training practices. Something external is essential! Hence we have Clause 7.7.2 which clearly requires some external involvement. One sometimes hears of laboratories who undertake some unique test or calibration for which there is no comparable other laboratory. I would not doubt that this may happen, but the trick then is to pick parts of the test or range, maybe looking at some inputs rather than at the final combined output. The Standard splits this into “Proficiency Testing” which is taken to be participation in a scheme run for that purpose and “participation in interlaboratory comparisons other than proficiency testing” which often entails making your own arrangements with other laboratories. Let’s now consider some of the possibilities in more detail: Use of reference materials. The use of any stable item, similar to the items to be tested but considered especially stable, may have a well-deserved place in a laboratory’s repertoire of activities. If it does not have a value ascribed to it, then it is still useful to use, maybe just after equipment is calibrated, and retain it for future use at intervals, or when malfunction is suspected. This technique is often relatively cheap to implement but remember that it will not show systematic components of uncertainty arising from an external source, or defective procedures, unless it is a certified reference material with a known value. Retesting of stable retained items cited in g) is a similar technique. Use of alternative instruments. If one has alternative and equal instruments both having external calibrations, then this technique is excellent because it will show faulty equipment. If the calibrations come from different sources all the better. Trevor Thompson of www.bestmeasurement.com offers advice about the use of Interlaboratory Comparison and Proficiency Testing activities as required by ISO/IEC 17025:2017. 89 bmta.co.uk If the lab has a bad technique always used then this will not help. Sometimes it is possible to lengthen and stagger the external calibrations by undertaking internal comparisons between the duplicated instruments. This also helps with removing downtime for calibration, but for some laboratories with very expensive measuring equipment or environments it may be prohibitively expensive and other ideas might be more appealing. Replicate or Repeat Tests may be applied in a variety of useful situations. This may be to compare operators where operator skill is central to the validity. It may be used also to compare equipment and environments. The technique may also be used to establish or check random components of uncertainty under static conditions and to investigate variables by constraining all but one and swinging that one between set extremes. Blind Testing. This has a slightly different meaning across industries but can be taken to be when an operator or even a whole lab does not know the source or sometimes the identity of the test item. Difficult to arrange, the technique is good for spotting corruption, conscious or unconscious bias and the taking of shortcuts. Aren’t we all aware of taking greater care if we know the test is for someone rather special in some way? Proficiency Testing Schemes are common in many testing areas, especially those involving operator acumen, eyesight or other skills and where a feature present or not may be involved. It is less commonly available for calibration, especially in the UK. In an ideal PT Scheme there would be a higher order laboratory with a reference value and artifact(s) are circulated between participants or sent to each from a known batch. There is a comprehensive directory of such schemes at https://www.eptis.org which is maintained by the most respected German Laboratory BAM in Berlin. Some PT Schemes are accredited to ISO/IEC 17043 and these would be preferable. PT Schemes vary in their composition and in the analysis of results. Some have clear reference values, some may use participant consensus values and may be affected by the performance of other participants. Laboratories should strive to find a suitable PT Scheme but may sometimes find, although worthwhile, that the application is not an exact fit for their work in terms of r anges and materials offered. Interlaboratory Comparisons (other than PT) may just be something arranged privately between two or more laboratories or may be a scheme typically for calibration and run, for example, by a National Measurement Institute. Comparing the results from ILCs and PT is usually done by using the relatively simple use of a formula known as En Ratio, Zed or Zeta Score. These are all similar but be aware that some testing schemes do not handle uncertainty of measurement in the complete strict sense that is expected in calibration labs. This formula may be used to compare any two measurements to see if, taking the Uncertainty of Measurement into account, the two values are potentially valid and come from the same population. A En ratio of less than 1 is valid. Some PT Schemes expect Zed or Zeta to be less than 2 or 3 for a satisfactory result. LV is the first laboratory value for any single measurement point RV is the same measurement point taken at another laboratory (may be a “better” reference laboratory) ULV and URV are the associated Uncertainties of Measurement for the values LV and RV. Simply taking the difference between the two values and dividing by the square root of the sum of the squares of the two uncertainties gives a measure of the validity of the result LV relative to RV and is therefore very effective for the LV lab if the RV lab has a lower UoM. It can be used to compare similar laboratories but is a less critical measure in that case. To see this graphically consider the diagram below where two laboratories with different UoM measure the same item. You can see the possible range of values for each lab and how they are compatible and potentially come from the same population, in this case because all possible values from both labs fall within the uncertainty ULV of the value LV. One may conclude therefore that both labs achieved a valid result. What if a Pass/Fail mark lies between the two lab values? In that case one lab considers the product passes, the other fails. Both may be valid results, but that topic (Decision Rules, taking uncertainty into account) is a subject for another day! 9Next >