< Previous2020 bmta.co.uk RISK BASED UKAS ASSESSMENTS By Jeff Ruddle, Strategic Development Director, UKAS UKAS had already, for many years, used a risk-based approach to plan our assessments. Lead Assessors and their teams having the flexibility to decide how frequently over the course of the 4 Year Cycle of accreditation they assessed aspects of the management system, technical activities, and any satellite locations. However, our teams were constrained to conducting their assessments on-site (until the advent of the COVID-19 pandemic) and on an annual frequency. The most recent version of ISO/IEC 17011 opened up the potential to vary the frequency of assessment and the use of remote assessment techniques. UKAS wanted to use this opportunity to enhance our current risk-based approach. So, in 2019 the UKAS board set a strategic priority to enhance our risk-based approach introducing elements of remote assessing and considering the possibility of varying the frequency of assessment. During 2019 UKAS conducted research into risk-based approaches used by other accreditation bodies and regulators operating inspection programmes. This research was used to design a project to develop a new risk-based approach which began in 2020. Throughout 2020 the project team worked with assessors and stakeholders from the Asbestos and Medical Laboratory sectors to develop an approach to risk evaluating conformity assessment bodies (CABs) in that sector. This resulted in the development of a risk evaluation matrix and guidance to assessment teams on assessment approach and frequency. In Feb 2021 a pilot of this approach was started in the Asbestos sector. It had been planned to also pilot the approach in the Medical Laboratory sector but the pressure on the sector related to COVID-19 testing means that the pilot has been delayed till later in 2021. How will risk be evaluated? The assessment team use the risk evaluation matrix which considers several indicators that draw on data from UKAS, the customer and third parties to evaluate the risk that a CAB presents. Broadly these Indicators fall into four categories – Uncertainty (as a result of change), Historic Performance, Complexity of Operations and External Factors. These indicators are weighted with more weight being placed on those indicators related to the performance of the organisation. Assessment teams provide responses to each indicator which provides an overall evaluation for the CAB. The outcome of this evaluation then guides the assessment team as to whether the CAB should be recommended for; Enhanced, Standard or Reduced Monitoring. Broadly these categories mean: • Enhanced Monitoring – the CAB is likely to require more frequent assessment and greater use of on-site assessment. • Standard Monitoring – the CAB is likely to require an annual assessment with a mix of remote and on-site assessment. • Reduced Monitoring – the CAB is likely to require an assessment less than once per year and greater use of remote assessment. It is important to remember that in all cases the CAB is still accredited and that the confidence provided by accreditation remains equal for all CABs regardless of approach. The approach to assessment reflects what it is necessary for UKAS to do to ensure that equal confidence is provided to clients and stakeholders of accredited organisations. The risk of a CAB is re-evaluated after each assessment event and the approach can change over the 4 Year Cycle of accreditation. Current Status of the Project The approach is currently being piloted with accredited Asbestos laboratories and inspection bodies. Pilots for the Construction Testing and Medical Laboratory sectors are planned for later in 2021 and Management System Certification Bodies, Engineering Inspection Bodies and Environmental Chemistry Testing Laboratories in 2022. These pilots will involve engagement with the stakeholders and customers of each sector communicating the plans to the pilot and involving them in the development of risk evaluation indicators as appropriate. These pilots will allow UKAS to evaluate the approach and the changes it makes to assessment planning and conduct with an aim of implementing the approach across all areas of UKAS operations by 2024. Please contact jeff.ruddle@ukas.com or Yasmine.dialdas@ ukas.com if you have any questions about the project. The revision of ISO/IEC 17011 “Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies” in 2017 placed more focus on accreditation bodies taking a risk-based approach to the planning and conduct of assessments. COMPANY PROFILE AUTOSCRIBE INFORMATICS bmta.co.uk 21 Many people in the industry will have heard of Autoscribe Informatics and its Laboratory Information Management System (LIMS) solution, Matrix Gemini. People tend to assume that Autoscribe is USA based but in fact it is a home-grown success with a UK development team located in offices near Reading. Founded in 1981, Autoscribe Ltd is a privately owned company. The founder, John Boother, is a qualified analytical chemist who had worked in sales for Beckman Instruments as the European Manager for Laboratory Automation. This role introduced him to the importance of laboratory management and automation systems. Realising a gap in the market for a PC based LIMS John expanded the Autoscribe operation into this market in 1990 and introduced in-house development in 1993. This coincided with big changes in the laboratory industry, and the instruments they use, with computers still in their infancy. Taking advantage of these early Windows-based personal computers (PCs) Matrix LIMS was born. From those early days, the software has been continually developed to utilise the latest technology and extended to meet the needs of increasingly sophisticated laboratories and the measurement testing they must perform daily. Today, Autoscribe has expanded beyond the UK to have offices in the USA and Australia, as well as distributors across Europe, Africa and Asia, making it a truly global organisation. Despite this, Autoscribe still has a family feel. Many of its earliest customers are still clients today. The heart of this success is a LIMS system that enables configuration via built- in configuration tools, allowing the system to be optimised to the exact needs of every laboratory, without the need for programming skills. While most LIMS require software code changes to change the screens within the LIMS for example, Matrix Gemini LIMS allows these changes to be made using the configuration tools. This allows clients to easily change the system to suit their needs while preserving the ability to upgrade to new versions of the software to take advantage of new and improved features. One unique feature of the Autoscribe approach is that customer changes to a Matrix system using the configuration tools are supported within the annual support agreement at no extra charge. This approach means that system changes, support of those changes and upgrades are easily achieved. Since its early days, Autoscribe has always recognised the value of trade associations such as the British Measurement and Trade Association (BMTA). The BMTA promotes the interests of its members, many of whom are laboratories, within the UK and globally, helping to drive best practice across the industry. Autoscribe is closely aligned with these goals, advocating that the LIMS solutions that BMTA members use should encapsulate and help laboratories adopt this best practice. To that end, the Matrix Gemini LIMS that we develop here in the UK and supply globally enables laboratories to comply with international standards such as ISO17025, FDA 21 CFR Part 11, and Good Laboratory Practice. Promoting these common objectives and listening to the needs of BMTA members allows us to develop the Matrix Gemini LIMS roadmap and keep it relevant to the needs of tomorrow’s laboratories.bmta.co.uk WORLD ACCREDITATION DAY 9th JUNE 2021 By Jeff Llewellyn, President, BMTA 22 World Accreditation Day is celebrated annually on June 9th by IAF, ILAC, their members and partners, and stakeholders in the conformity assessment community in acknowledgement of the benefits and value of accreditation. Previous themes for the day have included such diverse topics as food safety, adding value to the supply chain and delivering a safer world. World Accreditation Day 2021 will highlight how accreditation and accredited conformity assessment activities can support the implementation of the United Nations (UN) Sustainable Development Goals (SDGs); a series of 17 objectives that have been developed and adopted by United Nations member states as part of the 2030 Agenda for Sustainable Development. The SDG agenda is a plan of action for people, the planet and prosperity; it seeks to strengthen universal peace in larger freedom. The plan recognises that eradicating poverty in all its forms and dimensions, including extreme poverty, is the greatest global challenge and an indispensable requirement for sustainable development. The aim is for all countries and all stakeholders, acting in collaborative partnership, to implement this plan with the stated objective of freeing the human race from the tyranny of poverty and want, and to heal and secure our planet. The SDGs seek to build on the United Nations’ Millennium Development Goals and complete what these did not achieve, to realise the human rights of all and to achieve gender equality and the empowerment of all women and girls. They are integrated and indivisible and balance the three dimensions of sustainable development: economic, social and environmental. This sets the scene for action over the next 15 years in areas of critical importance for humanity and the planet: The UN has highlighted the following: People We are determined to end poverty and hunger, in all their forms and dimensions, and to ensure that all human beings can fulfil their potential in dignity and equality and in a healthy environment. Planet We are determined to protect the planet from degradation, including through sustainable consumption and production, sustainably managing its natural resources and taking urgent action on climate change, so that it can support the needs of the present and future generations. Prosperity We are determined to ensure that all human beings can enjoy prosperous and fulfilling lives and that economic, social and technological progress occurs in harmony with nature. Peace We are determined to foster peaceful, just and inclusive societies which are free from fear and violence. There can be no sustainable development without peace and no peace without sustainable development.bmta.co.uk 23 Partnership We are determined to mobilise the means required to implement this Agenda through a revitalised Global Partnership for Sustainable Development, based on a spirit of strengthened global solidarity, focused in particular on the needs of the poorest and most vulnerable and with the participation of all countries, all stakeholders and all people. The interlinkages and integrated nature of the Sustainable Development Goals are of crucial importance in ensuring that the purpose of the new Agenda is realised. If we realise our ambitions across the full extent of the Agenda, the lives of all will be profoundly improved and our world will be transformed for the better. • Goal 1. End poverty in all its forms everywhere • Goal 2. End hunger, achieve food security and improved nutrition and promote sustainable agriculture • Goal 3. Ensure healthy lives and promote well-being for all at all ages • Goal 4. Ensure inclusive and equitable quality education and promote lifelong learning opportunities for all • Goal 5. Achieve gender equality and empower all women and girls • Goal 6. Ensure availability and sustainable management of water and sanitation for all • Goal 7. Ensure access to affordable, reliable, sustainable and modern energy for all • Goal 8. Promote sustained, inclusive and sustainable economic growth, full and productive employment and decent work for all • Goal 9. Build resilient infrastructure, promote inclusive and sustainable industrialisation and foster innovation • Goal 10. Reduce inequality within and among countries • Goal 11. Make cities and human settlements inclusive, safe, resilient and sustainable • Goal 12. Ensure sustainable consumption and production patterns • Goal 13. Take urgent action to combat climate change and its impacts • Goal 14. Conserve and sustainably use the oceans, seas and marine resources for sustainable development • Goal 15. Protect, restore and promote sustainable use of terrestrial ecosystems, sustainably manage forests, combat desertification, halt and reverse land degradation and halt biodiversity loss • Goal 16. Promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels • Goal 17. Strengthen the means of implementation and revitalise the global partnership for sustainable development Keep an eye on the UKAS website at www.ukas.com and that of the International Accreditation Forum (IAF) at www.iaf.nu leading up to June 9th to learn how accredited conformity assessment can play its part in the successful implementation of these goals. WORLD ACCREDITATION DAY 9th JUNE 2021BMTA COUNCIL MEMBER PROFILE PAUL GREENWOOD OPERATIONS DIRECTOR, UKAS bmta.co.uk 24 Can you briefly describe your job, Paul? PG – I oversee the provision of accreditation of over 3,000 conformity assessment bodies that undertake a huge range of activities in the Testing, Inspection and Certification (TIC) field. I’m an executive member of the UKAS Board, responsible for ensuring the strategic development and delivery of accreditation nationally and internationally. And how long have you been working in your field? PG - I’ve been working in accreditation for 15 years, following my 13 year career as a chemist spent predominantly in the water and environmental sector, undertaking metals and inorganic analysis. What do you think is your biggest accomplishment in your career? PG - I suppose it is to have succeeded in rising to my current role at UKAS with complete oversight of all the accredited activities in the UK, directing over 180 staff in incredibly diverse areas of operation - healthcare, drinking water, forensics, carriage of dangerous goods, consumer product testing, construction products, food and agriculture, environmental, information security, gas installer schemes are just a few of the many disciplines we support with our independent oversight. How did you get to where you are? What was your career journey? PG - I studied for a BSc (Hons) in applied chemistry with analytical chemistry at Liverpool John Moores University. The course allowed me to spend a year working in industry and I was lucky enough to secure a placement at BNFL analysing plutonium in their technical department. This really helped me to develop my analytical and other practical skills and my first interaction with a robust, structured quality management system. Paul Greenwood (CChem MRSC) joined UKAS in 2006 after a 13-year post-graduate career as a chemist in the fields of nuclear chemistry, drinking water analysis, environmental testing and analytical instrumentation. In addition to oversight of the accreditation of over 3,000 conformity assessment bodies, he is an executive member of the UKAS Board and responsible for ensuring strategic development and delivery of accreditation nationally and internationally. Paul represents UKAS on the council of the British Measurement and Testing Association (BMTA) and is an active strategic board member of the Standing Committee of Analysts (SCA). We asked Paul to tell us about himself. Our new feature on our BMTA Council Members gives a little more insight into the people behind BMTA. Why did they become BMTA Council members and what do they believe are the benefits to being a member of the Association. bmta.co.uk 25 Following graduation, I worked for an analytical instrument manufacturer (Jobin Yvon / Horiba) as an Applications Specialist. Following several years in that role, I took a position as Head of Inorganic Chemistry for South Staffordshire Water (SSW) which required analytical and process (treatment) chemistry knowledge. When the laboratory operations of SSW were outsourced to Severn Trent, I moved to TES Bretby (now Socotec) as an analyst at their environmental chemistry laboratory in Burton-on-Trent, then for a short spell back into an Applications Specialist role for Thermo Elemental (spectroscopy). I returned to TES Bretby as Head of Wet Chemistry and subsequently Head of Metals Section. I joined UKAS in 2006 as an Assessment Manager and through promotion to Head of Environmental Chemistry in 2010, and Divisional Director (Operations) in 2012, finally took the role of Operations Director in January 2019. Why do you do what you do? What gets you up in the morning? PG - There is so much to do to improve quality in the conformity assessment sector and I definitely see my role as a vocation! My job certainly doesn’t give rise to significant tangible physical outputs from me because so much of my time is spent resolving issues, negotiating or directing the actions of others to deliver our services. My satisfaction comes from the knowledge that successfully achieving what we do is helping to improve competence and compliance of our accredited customers and improving confidence in products and services for end-users of accreditation. How long has your company been a member of BMTA? PG - Certainly longer than my time at UKAS, well over 15 years. Why did UKAS join BMTA? PG - There is a natural synergy between the two organisations - we have a reciprocal agreement and BMTA are themselves members of UKAS. By working together we feel we can improve our understanding of accreditation and its role in improving the quality of testing and measurement whilst at the same time making sure that we are not making that process too onerous or unnecessarily complex for accredited customers and their clients. What value do you receive as a member of BMTA? PG - It’s an opportunity to hear and hopefully resolve customer feedback on issues relating to accreditation. You’re a member of the BMTA Council. Why did you join the Council? PG - I joined the council as a co-opted member in 2021 but have had observer status since 2012 when I became UKAS’ Divisional Director (Operations) to take queries and make responses to the council on UKAS’ behalf What else can you tell us about yourself? PG - I am a keen archer and have been an active member of a number of archery clubs for the past 40 years. I currently live with my family in the beautiful city of Lichfield which is incredibly well placed to allow easy travel to pretty much anywhere in the UK and abroad. My musical tastes are broad and eclectic, covering pretty much everything with the exception of free-form jazz! I do like to read sci-fiand comedy in my spare time, so Douglas Adams and Terry Pratchett are particular favourites.Contribute to the BMTA newsletter... To help us research and plan the most relevant and useful information for BMTA members we would like your help to identify and share relevant topics, research on new technologies, techniques, news, events and publications you think may be of interest or would like to promote to your fellow BMTA member community. Send your article to: editor@bmta.co.uk with a short synopsis and an image and brief biography of the author. 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