Annual Quality Manager s Report 2015

Transcription

1 Annual Quality Manager s Report 2015

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3 Annual Quality Manager s Report

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5 ANNUAL QUALITY MANAGER S REPORT 2015 EFSA is committed to meeting or exceeding customer requirements and enhancing customer satisfaction through active and continuous improvement of its quality management system (QMS), thus creating trust in the European food safety system. 1. Summary 2015 saw further progress towards implementing a quality management system (QMS) based on ISO 9001:2015. Highlights included: a very positive opinion by the European Commission (DG SANTE) on the quality of EFSA s scientific outputs (defined by the criteria fitness for purpose and clarity in communication); a very positive opinion by the External Review Working Group (ERWG) on the Quality Assurance System for Science developed by EFSA; the strengthening and harmonisation of the QMS across all of EFSA. The target to achieve a fully integrated QMS compatible with ISO 9001:2015 for the whole organisation by the end of 2016 is within reach. 2. QMS Operation progress made in Quality Circle The Quality Circle (QC), composed of one quality correspondent per unit, continued its monthly meetings during 2015 with the aim of exchanging information, sharing best practice and ensuring effective implementation of the Plan-Do-Check-Act quality cycle. The three verification exercises carried out in 2014 by QC members were extended in 2015 to cover units across all of EFSA. The activity demonstrated a very high implementation level of Standard Operating Procedures (SOPs) within the units and again proved a valuable tool both for identifying areas for improvement and spreading best practice External review In 2015, the last year of their mandate, the External Review Working Group (ERWG) evaluated 20 third-party outputs (ENs) randomly selected by EFSA, and provided a review of the Quality Assurance System for Science developed by EFSA. The evaluation criteria for the third-party outputs included scientific rigor, timeliness and clarity in communication. The review was carried out following the same process 3

6 and same criteria as during the previous years. The recommendations highlight the need to further improve the quality of third-party reports. EFSA has already started to look into the issue. The Quality Assurance System for Science, which was developed by EFSA during the first half of 2015, will effectively move the organisation away from the old system based on quality control. The ERWG provided very positive feedback on this new system. EFSA will build on this review and fully implement the new system by mid Customer feedback The collection of customer feedback is an essential element of EFSA s continuous improvement programme, and the successful completion of this exercise meets a key requirement of the ISO 9001:2015 standard. The customer feedback exercise was set up in 2014 and repeated in 2015 by expanding the interviews to cover outputs from all EFSA panels. As in 2015, the quality criteria defined were fitness for purpose and clarity in communication. The feedback received during the interviews was well prepared by DG SANTE staff, supported by examples, constructive, balanced and self-critical. Within DG SANTE there is clearly a high degree of trust and respect for EFSA, a good understanding of EFSA s context and constraints along with a strong desire to maintain the current good working relationships. Overall the quality of EFSA s work was rated as high by all DG SANTE staff interviewed. A repetition of the exercise is planned for Independent assessment against ISO 9001:2015 In order to have a sound basis for the go/no-go decision regarding the ISO certification for EFSA, the organisation requested a third party to carry out an independent assessment of the whole agency against the ISO 9001:2015 standard. The outcome of the assessment was very positive: the QMS was found to be firmly established across all EFSA departments and, as a consequence, the certification was found to be within reach. 3. QMS Operation next steps for Towards ISO 9001:2015 certification In view of the outcome of the independent assessment carried out in October 2015, which found that the QMS is firmly established across EFSA, the decision was taken to apply for the certification in autumn In preparation for this, a pre-certification audit will be carried out in May, which will leave time to close any remaining gaps before the certification audit planned for autumn Finalising the implementation of the Quality Assurance System for Science The system designed by EFSA staff and positively reviewed by the ERWG is being implemented step by step. The main issue that remains to be addressed is the replacement of the ERWG by setting up a quality review process to take place before an 4

7 opinion is adopted, as opposed to the current ex-post quality control mechanism. The Scientific Committee will discuss concrete proposals in February Quality Circle The members of the Quality Circle (QC), who in 2015 received training on SOP writing and carrying out verification exercises, will receive further training in This training will be organised in view of the organisation s plans for ISO 9001:2015 certification and the need to allow QC members to effectively play their role as ISO satellites in their units Further system harmonisation As the customer feedback mechanism with DG SANTE is firmly established for science, the focus in 2016 will be on developing feedback mechanisms also for the RESU and COMMS departments. This will be done following a stepwise approach, by first establishing who are the customers or end users of the various processes and what are the customer requirements, and then how to measure satisfaction and derive actions for improvement. 5

8 TM-AY EN-N Via Carlo Magno 1A Parma ITALY ISSN ISBN: doi: / Tel Fax Photo credits: EFSA, Getty Images, istockphoto, Shutterstock, Studio Valle Progettazioni, Art & Build, Manens -Tifs, Pool Engineering, Art Ambiente Risorse e Territorio European Food Safety Authority, Reproduction is authorised, except for commercial purposes, provided that the source is acknowledged. 2