EA-EUROLAB-EURACHEM Working Group: Proficiency Testing in Accreditation Procedures (EEE-PT)

Transcription

1 = Page 1 of 7 = EEE/pt(07)M24 EA-EUROLAB-EURACHEM Working Group: Proficiency Testing in Accreditation Procedures (EEE-PT) held on 20/21 November 2007 at Borås, Sweden Attendance Members: Apologies: Brian Brookman (BB/LGC/EURACHEM/Chairman) Natalie Stephenson (NS/LGC/Secretariat) Kirsten Jebjerg Andersen (KA/DANAK/EA) Frank Baumeister (FB/ISWA/EURACHEM) Magnus Holmgren (MH/SP/PLG) Christian Lehmann (CL/DAR/DAP/EA) Ulrich Leist (UL/DRRR/Eurolab) Irma Mäkinen (IM/SYKE/Eurolab - EURACHEM) Ian Mann (MI/SAS/EA) Piet Meijer (PM/ECAT/EQALM) Gunnar Nordin (GN/EQALIS/EQALM) Jeff Ruddle (JR/ UKAS/EA) Pavla Dvorakova (PD/CAI/EA) Holger Frenz (HFr /FH-Gelsenkirchen/Eurolab) Maria Grazia del Monte (MM/SINAL/EA) Laura Lodesani (LL/Tec-Eurolab) Annika Norling (AN/SWEDAC/EA) Marina Patriarca (MP/ISS/EURACHEM) Piotr Robouch (PRB / IRMM/ EURACHEM) Pedro Rosario Ruiz (PR/Eurolab) Carmen Garcia Villarragut (CV/ENAC/EA) Tony Russell (TR/NATA/ILAC) Alan Squirrell (AS/NATA/ILAC) Dan Tholen (DT/USA/A2LA) List of references 1. Agenda 24th Meeting = EEE/pt(07)A24draft 2. Draft minutes of 23rd Meeting = EEE/pt(07)M23 3. Documents distributed for the meeting: EEE/pt(05)08 EEE/pt(06)26, 44, 46, 47, 48, 49, 57 EEE/pt(07)02, 04, 13, 17, 21 front, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, A24draftrev, M23draft, ML24 4. Document presented at the meeting = EEE/pt(07)53 Please send your comments to the minutes by 28 th February 2008 to the EEE-PT Secretariat: Attn. Natalie Stephenson LGC Standards Europa Business Park, Barcroft Street, Bury, BL9 5BT, UK Tel. +44 (0) Fax. +44 (0) natalie.stephenson@lgcpt.com

2 = Page 2 of 7 = EEE/pt(07)M24 1. WELCOME AND APOLOGIES BB opened the meeting, which was then addressed by the host, MH. BB thanked MH for his hospitality and hosting the meeting and welcomed the participants to Boras. 1.1 Membership and apologies for absence The Secretariat listed the apologies received for the meeting, and BB welcomed the new attending person: - Piet Meijer (PM/ECAT) representing EQALM 1.2 Date and Place of next meeting IM offered to host the next meeting (25 th ) in Helsinki on Tuesday 13 th and Wednesday 14 th May Action : NS to circulate next meeting details Action : NS and IM to liaise with further meeting details and circulate when available It was discussed that the 26 th EEE PT WG meeting may be held to coincide with the ILAC General Assembly/ILAC PTCG meeting in Stockholm in November Action : BB to speak to ILAC 2. APPROVAL OF THE AGENDA OF THE MEETING = EEE/pt(07)A24draft The agenda was approved. 3. APPROVAL OF THE MINUTES OF LAST MEETING AND FOLLOW-UP OF ACTIONS EEE/pt(07)M23draft The minutes were agreed as an accurate record of the meeting. Follow-up of actions from the 22nd meeting: - Action : Complete. - Action : Complete. - Action : No need to continue. - Action : Circulated with documents for the meeting. - Action : Complete. - Action : Complete. - Action : Complete. - Action : Complete. This was discussed under item Action : Complete. - Action : This was discussed under item Action : This was discussed under item Action : This was discussed under item Action : This was discussed under item Action : This was discussed under item Action : This was discussed under item Action : Complete. - Action : Complete. Discussed under item Action : Not discussed. CV did not attend the meeting. - Action : Most of the work the ILAC PT WG do will be based around the survey discussed in Sydney. The results of this survey have not yet been received. Discussed further under item Action : Members area of VAM website was closed due to security problem. A new website has been launched, which could include a EEE PT WG member s area. Action : NS to be trained on how to use the website, set up member s area for EEE PT WG and the members. Action : Relevant members to ask Eurolab and Eurachem to update the EEE PT section on their websites.

3 = Page 3 of 7 = EEE/pt(07)M24 4. REPORT OF INTERNATIONAL MEETINGS AND ACTIVITIES 4. 1 EUROLAB: MH reported that at the members meeting in Berlin, a major item was the new approach directive. There was a memorandum outstanding for Euramet and GRC regarding the dissemination of the GRC. There were workshops on accreditation to assess the competency of laboratories. Participants were EA, Eurachem, Euramet and Eurolab. Participation is available on the Eurolab website EURACHEM: BB reported that the Eurachem PT WG had completed the first issue of the bibliography for PT documents. The first issue of this bibliography will be on the Eurachem website shortly and there will be a link to it from EPTIS. The bibliography will be updated once a year. Details on any relevant documents for the bibliography should be ed to Piotr Robouch. The discussion paper on Terms and Definitions relating to PT, which highlights a number of differences in definitions used in various international standards and guides, is available on the Eurachem website. The intention of this document is to strive for consistency within the terms used regarding PT. The main current activity is the organisation of the next workshop, in collaboration with EQALM and CITAC, which will be held on 5 th -7 th October 2008 in Rome. On the 5 th, there will be two training courses, one on Statistics in PT and another on the Selection, Use and Interpretation of PT schemes. The actual workshop will be held on 6 th and 7 th, with invited speakers and WG discussions around these topics. Associated events will be a poster session and a small exhibition. An information leaflet is being produced on pre- and post- analytical PTs. Action : All members to forward the flyer promoting the workshop to PT providers/ participants to promote the activity EA Laboratory committee: BB reported that the EA would like the Frequency paper to be completed so that it can be adopted as an interim document whilst ILAC P9 is revised. They would like the EEE PT WG to complete this document at the meeting. There were no further PT issues EA LC WG on ILCs in Testing: CL reported that the work on evaluating PTs continues. UL from DRRR, will now work with the group. The paper regarding how they can work with various PT providers to support the MLA is nearly complete. The LC have given positive feedback regarding the document and it should be approved at the next meeting EQALM: GN reported that a meeting was held in June in Amsterdam with EuroMedLab. 100 participants attended the meeting, regarding a review of PT exercises in the field of medical science, historical and future prospects. A small newsletter is produced for their members and this was distributed at the meeting. In future this will be available in electronic format on the EQALM website. They will participate in the Eurachem workshop and they will hold a General Assembly during the next National Symposium on 11 th and 12 th September in Birmingham APLAC: There was no representative from APLAC, but reference was given to the papers on the agenda. Document EEE/pt(07)48 refers to current and future PT programs and APLAC s collaboration with various bodies. There were no comments regarding the report. APLAC members will hopefully be able to attend the EEE PT WG meeting in November 2008 if it is held at the same time as the ILAC General Assembly ILAC PTCG: There was no representative from ILAC, and nobody had attended the last meeting in Sydney. However, MI/BB reported on their activities. Progress is being made on ILAC P9 and they have requested the EEE PT WG s finalised Frequency paper. It was agreed at the ILAC General Assembly to have MLA for PT. A small working group are to investigate the transport of PT samples. This was previously led by Mike Noble, but following his resignation, Steve Sydney (South Africa) and Julie Russell (UK) are to take the work forward. One of the main issues is trying to get samples through customs. One problem is that there is no specific tariff code for PT samples. However, now that the reference materials producers have succeeded with getting a specific tariff code for Certified Reference Materials, it should hopefully also be possible with PT samples. Various

4 = Page 4 of 7 = EEE/pt(07)M24 examples of transport issues were discussed in the meeting and it was decided that the EEE PT WG will act as an interim point regarding this discussion. Action : All to forward key examples of experiences to NS, to be forwarded to Steve Sydney. Action : NS to include this subject as an agenda item in future. Action : MI and CL to ask WADA how they are sending samples around the world. BB will attend the next ILAC PTCG in Cape Town in April and therefore we will have more feedback for the next EEE-PT WG meeting PLG: MH reported that at the last meeting of the PLG the topics discussed included: the workshop - "Accreditation - A tool to develop competence"; Eurolab s questionnaire on the use of the accreditation symbol and the appreciation of the accreditation with flexible scope; the revision of ILAC G13 and ISO/IEC Guide 43; the EA document about Flexible Scope; How to deal with Measurement in connection with conformity ; and the policy for commonly-developed EEE documents. The future activities of the PLG were also discussed and they decided to have a selfassessment of their past performances and future prospects. Regarding the EEE PT documents, the suggested amendment of the Terms of Reference was approved and there was a discussion regarding the Work Programme OTHER INTERNATIONAL ACTIVITY: GN reported that the final draft of a document on Metrological traceability of measurement results in chemistry has been produced by IUPAC. Action : GN to forward this IUPAC document to NS to be circulated to the EEE PT WG. 5. EEE-PT WG REVIEW 5. 1 Membership: No comments. EQALM can have three representatives at the EEE PT WG if they require but it was reported that only two members will probably attend in future EEE-PT WG Terms of Reference: The PLG have accepted the Tof R so this discussion can now be closed. EEE/pt(07)24 is the finalised document. The Tof R should be reviewed every 3 or 4 years if necessary EEE-PT WG Work Programme: The current draft Work Programme is EEE/pt(07)25. Further to discussion of the document, it was decided that the 5 year programme was too long; therefore this will be revised every two years. Action : BB to amend the WP to cover just An annex was added to this document to demonstrate the achievements of the EEE PT WG. Action : BB to ask the BAM secretary if any further documents can be added to the annex. Action : NS to add the documents in Annex A on the new website. Action : BB to contact parent organisations to review the success and future of the EEE PT WG. The issue of problems with training of assessors and problems with the acceptability criteria used by PT providers were raised. However, it was decided that these issues shall be covered in the Selection, Use and Interpretation document. If any further issues are raised, they could be added to the WP. The changes suggested by CL were discussed with the following decided upon: point 3b is relevant but in the incorrect position; item 5 should have two new points on Guidance (inspection) and Guidance (bilateral); a grading of importance of issues on the WP is needed. Action : BB to amend WP and NS to circulate.

5 = Page 5 of 7 = EEE/pt(07)M24 6 PREPARATION OF EEE-PT DOCUMENTS 6. 1 Selection, Use and Interpretation of Proficiency Testing Schemes by Laboratories: MI is leading a small WG to revise this document, originally written by Eurachem in 2000 to educate laboratories. The WG shared the tasks to revise the document and update the old references. The current draft includes the old version and new information and needs to be revised again. MI reported that no input had been received from EQALM so far and examples from the medical field could be of interest. MI also welcomes updated examples from PT providers regarding statistics; short-term/long-term evaluation and the difference of results using different standard deviations. Any suggested changes to the document should be sent to MI using Track Changes. The main suggested changes of this document were as follows: - Title: by Laboratories should be deleted from the title of the document. Change approved. - Section 4 on Statistics: should be revised further and re-ordered as robust statistics are becoming common practice. - Section 5 on Corrective Action: it was discussed whether this section was relevant and if a reference to the relevant standards might be of more use. - To distinguish between the Laboratory and Quality Managers may not be useful as this is the decision of each individual company. - Need for examples regarding trend analysis. - The formatting should be revised: perhaps bullet-points and boxing would be more useful in certain parts. Action : All to send comments and examples to MI by the end of January. Action : IM to revise and circulate the document before the next EEE PT WG meeting Frequency of Participation of Laboratories in PT: ILAC PTCG discussed P9 in Sydney and expressed concern regarding the understanding of sub-disciplines. The work of this WG will input into this. The purpose of this document is to further define the sub-disciplines established by the EA document, which were too broad. Sub-disciplines must be clearly defined or laboratories will create their own definitions. The document was discussed thoroughly and it was agreed that the document still needs further examples and further revision. A number of changes were suggested to the text. JR amended the text at the meeting and will circulate the revised document to members. Action : JR to circulate the amended document to CV and other WG members for comments then CV to circulate to all EEE PT WG as soon as possible. There was some discussion around the length of the participation plan and it was agreed that, whilst the participation strategy should be stated to cover the period between at least one accreditation cycle, there would be no need to have detailed participation for that period. This should be reviewed annually at the management review. An exercise was carried out using two UKAS scopes of accreditations to try to focus how this document would be applied. From this exercise, it was agreed that a sub-discipline should contain a minimum of one technique, one property and one product. There could be more than one in any category. It was also decided that an Annex should be added with examples of Case Studies to try to explain the definitions. Action : All to forward any further comments or examples to CV by the end of December. Action : WG to produce next draft and send to EA and ILAC. 7 DISCUSSION OF SUBJECTS AND DOCUMENTS 7. 1 Revision of ISO/IEC Guide 43 (ISO/IEC 17043): DT has forwarded the 3 rd draft of this document to the EEE PT WG for comment. Two comments have been received (from PD and IM) and BB will take these forward. After the next meeting of the WG in January, there will be a further draft. The final draft is hoped for at the end of GN commented that the ILC and PT definitions were not clear and will forward these comments back.

6 = Page 6 of 7 = EEE/pt(07)M Is there a need for sector specific PT standards?: Regarding the PT standard for Water, this is not going forward as a standard but is now being reviewed as a technical specification. DT has asked for a general discussion on whether sector specific standards are relevant or is ISO/IEC sufficient? It was agreed that the common standard should be written clearly enough for implementation in all fields. If there is any need for clarification, guidance can be given in the standard. It was agreed by all present members that ISO/IEC should be sufficient to cover all areas. If any guidance on the implementation of the standard in specific sectors is required this can only be decided after ISO/IEC is published PT for Sampling: The EEE PT WG are awaiting feedback from the ILAC Accreditation Committee (AIC), who are also considering the issue of sampling, to how the EEE-PTWG might be able to assist, and also to avoid duplication of effort. The Frequency paper and other documents could be structured so that they cover other areas (such as Sampling). There are no moves to get accreditation for PT for sampling as yet. Action: : Any accreditation bodies that have labs who require accreditation for PT for sampling to feedback details to this WG regarding any key issues. For the next meeting we will hopefully have feedback from ILAC so that the EEE PT WG can discuss how this subject can be taken forward. 8. UPDATES 8.1 EPTIS: An IT expert has recently started to re-program the research tools that will make searching of the database more efficient, e.g. free text searches. It will also enable the database to be transferred to a more up to date server. At present, PT providers complete just the Detailed information section of the website and not the basic information. This is being changed such that PT providers will be able to input all the data, after approval by the respective national coordinator. The use of EPTIS continues to grow but the main concern is still the funding. The German government provides a large proportion of funding, but this is not likely to continue. The only other option would be to charge PT providers for having their information on the EPTIS database. The EPTIS Secretary is talking to EA, ILAC and the European Commission to try to obtain funding. If EPTIS was discontinued, this would have implications for accreditation bodies that use it as their listing of PT providers. 9. SUBJECTS AND DOCUMENTS FOR INFORMATION: All documents have been referred to in the meeting. Ulrich Leist gave a short presentation regarding his new company, DRRR. 10. ANY OTHER BUSINESS There was no other business. 11. CLOSURE The chairman thanked all the members for their participation and actions fulfilled and especially to MH for the arrangements and hospitality. The meeting was closed at 12:25.

7 = Page 7 of 7 = EEE/pt(07)M24 APPENDIX I: LIST OF ACTIONS Action : NS to circulate next meeting details Action : NS and MH to liaise with further meeting details and circulate when available Action : BB to speak to ILAC Action : NS to be trained on how to use the website, set up member s area for EEE PT WG and the members. Action : Relevant members to ask Eurolab and Eurachem to update the EEE PT section on their websites. Action : All members to forward the flyer promoting the workshop to PT providers/participants to promote the activity. Action : All to forward key examples of experiences to NS, to be forwarded to Steve Sydney. Action : NS to include this subject as an agenda item in future. Action : MI and CL to ask WADA how they are sending samples around the world. Action : GN to forward the IUPAC traceability document to NS to be circulated to the EEE PT WG. Action : BB to amend the WP to cover just Action : BB to ask the BAM secretary if any further documents can be added to the annex. Action : NS to add the documents in Annex A on the new website. Action : BB to contact parent organisations to review the success and future of the EEE PT WG. Action : BB to amend WP and NS to circulate. Action : All to send comments and examples to MI by the end of January. Action : MI to revise the document before the next EEE PT WG meeting. Action : JR to circulate the amended document to CV and other WG members for comments then CV to circulate to all EEE PT WG as soon as possible. Action : All to forward any further comments or examples to CV by the end of December. Action : WG to produce next draft and send to EA and ILAC. Action: : Any accreditation bodies that have labs who require accreditation for PT for sampling to feedback details to this WG regarding any key issues.