The Changing Assessment Process Graham Fews West midlands Regional Genetics Laboratory UKAS Technical Assessor Disclaimer • UKAS Technical Assessors do not offer consultancy. • The views presented are my own and do not necessarily portray those of UKAS. Bermuda triangle? • Is the ISO 15189 process full of myth, mystery and misunderstanding? • Assessors have ‘split roles’ – WMRGL, UKAS, NSHCS. • If you go home with a more clear understanding of ISO 15189 the day will have been worthwhile. Myth • We are moving from CPA standards to ISO 15189. • Not strictly true – CPA standards always referenced relevant clauses within ISO 15189 and other relevant Standards. • The first assessment is a gap analysis. • Not true - It is the laboratory’s responsibility to undertake the gap analysis. Technical Assessors • Peer Assessors have become Technical Assessors. • Technical assessors are still critical to the success of the assessment process. • Our role is to assess Technical Requirements and the clauses within. • This does not mean we will not identify nonconformity within our clauses during our investigations. • All assessors undergo training in ISO 15189. • All assessors are assessed for their competence in ISO 15189 assessment. • UKAS themselves are also assessed. • Quality is at the heart of the whole process. Previously… • CPA assessment utilised: – Vertical Audits – Horizontal Audits – Examination Audits – User Meeting / Questionnaire. Now… • UKAS assessment under ISO 15189 uses assessment by ‘any means’ to get to the required end point. • However; the process is considered more holistic. • The majority of technical assessment is provided by witness audit. • The initial assessments are generally long. AC4 form • Labs have to complete AC4 form. • This provides the scope of testing that the laboratory is asking to be assessed against. • Requires details of tests, sample types, key equipment and SOPs. • Think about how you fill it in. • If you are too specific any new testing may require an extension to scope. • This form is given to the Assessment Manager who will organise the assessment. • The Assessment Manager contacts Technical Assessors to check availability. • Technical Assessors do not know who the lab is until the visit has been confirmed. Before the visit • Labs will be asked to provide relevant information including key SOPs for assessors to review. • Assessors read and prepare for the visit. • UKAS include this assessor preparation time in the calculation of visits. During the visit • The assessor team will arrive and have a welcome meeting with key staff. • There is no requirement for a closing meeting each day. • Assessors will assess each area within the scope of assessment. • Findings will be fed back as soon as possible to enable labs to decide what action will be taken. Non-conformities • Previously non-conformities were given for each part of an examination where appropriate. • Under ISO 15189 the aim is to identify the specific cause that has occurred. • Assessors use more of a route cause model in the assessment process. Be prepared! • In general the holistic nature leads to a friendly, open assessment. • Think ahead – prepare a list of what assessors can see when. • If they won’t be able to see something let them know asap so alternative means of assessment can be performed. • Have relevant paperwork to hand – EQA reports etc. • Assessors will wish to see training, competence and CPD records. At the end of the Assessment • At the end of the assessment the assessor team will meet with key staff and go through the list of non-conformities. • Labs are required to provide information as to how they will clear the non-conformity. • These agreed actions will be documented on the Improvement Action Report and a copy left with the lab and sent to UKAS. • At this stage the Assessment Manager will recommend whether department has attained the required level to a) maintain CPA accreditation b) be recommended for ISO 15189 accreditation. • Accreditation is only given once nonconformities are cleared. • CPA non-conformities are to be cleared in 8 weeks. • UKAS non-conformities are to be cleared in 12 weeks. Post assessment • Assessors write up a report on the visit. • This report is provided to both the department and UKAS. • Labs must provide evidence for clearing nonconformities within the relevant timeframe. • UKAS ISO 15189 accreditation is currently only ratified approx twice a year until fully embedded. Schedule of Accreditation • The Assessment Manager and Lab will work together to develop a Schedule of Accreditation. • This is what you are accredited to provide. • IMPORTANT – it is the assessed tests that are accredited and NOT the laboratory. • Any new tests or changes to accredited equipment requires consideration of an extension to scope. Caution… • ISO 15189 is subject to copyright. • If a provider of a service is UKAS accredited for that service they will provide a certificate that shows the UKAS logo. • If a provider of a service says they are traceable to UKAS/ISO standards ask how. And Finally… • Technical Assessors are not paid. • It is hard work, but rewarding. • Assessment process relies on availability of assessors. • It is your profession - be involved.