Standard Operating Procedure

Standard Operating Procedure
Quality Management Review
Public
Scope The evidence based annual review by EFSA’s Management Team of

the performance of the organisation’s quality management system, to
ensure it is fit for purpose, adequate and effective. The annual
Management Team Review completes the Plan/Do/Check/Act cycle.
Special This procedure is a controlled document maintained by Quality

Requirements Management. It may not be deleted without comparable controls.
Please note that this document becomes uncontrolled once printed. Make sure by
always referring only to the Repository that you have the right version in use
Responsibilities • EFSA Management Team: perform the quality management review

• QM: support the quality management review (prepare, facilitate,
report and monitor follow-up)
Abbreviations and definitions

DMS Document Management System
QM Quality Management
MT Management Team
Non-conformity A non-conformity or non-compliance is the “non-fulfilment of a
(NC) requirement”
A non-conformity takes place when one (or several) of the following
conditions are fulfilled;
• It constitutes either an overruling or a deviation from mandatory
processes and procedures;
• It represents a gap in existing controls;
• It might constitute a breach of existing regulatory and/or
contractual provisions;
In case of a non-conformity the finding has already happened – it is
thus detected after (ex post) the related non-compliance has occurred.
This is to be differentiated from an exception, which is approved by the
responsible person before (ex-ante) the overruling or deviation has
taken place.
Preventive An ex ante action to eliminate the cause of a potential non-conformity
Action (PA) or other undesirable potential situation before they have actually
occurred. Preventive action is taken to prevent the occurrence of non-
conformity.
QC Quality Circle consisting of one Quality Correspondent per unit in
EFSA, meets monthly and is coordinated by Quality Management
QMS Quality Management System
SOP Standard Operating Procedure
Internal Quality EFSA has a team of Internal Quality Auditors which on an annual or
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SOP_032_M – Quality Management Review 1/3
Public
Audits biannual basis audit every Unit in the organisations against a particular
Audit scope/goal.
Procedure
Previous SOP in the process: n/a
Step 1 1.0 Preparation of the management review
QM, Quality
circle
1.1 During the last quarter of each year, QM prepares the annual
management review of the quality management system by
collecting the following inputs:
• process performance and product/ service conformity;
• follow-up actions from previous management reviews
• recommendations for improvement;
1.2 Based on this input, QM prepares a draft report to support the
management review.
1.3 The draft report is discussed with the Quality Circle as well as at
the departments´ management team meetings
Step 2 2.0 Quality Management Review
QM,
Management
Team
2.1 QM places the item Management Review on the MT agenda and
submits the draft report and deadlines by end of Jan n+1
The Management Review takes place through a meeting of EFSA’s
MT facilitated by QM. During the meeting EFSA’s QMS is reviewed
based on the evidence collected (listed under 1.1) and the report
provided.
2.2 QM presents previous year´s quality performance criteria together
with
- performance against the criteria
- proposal for improvement
2.3 MT to confirm performance targets for following year and agree on
improvement actions to close the gap.
The outcome will feed into the Quality Manager´s Report as a building
block of assurance.
Step 3 3.0 Monitoring of actions implementation
QM,
Management
Team
3.1 QM monitors the implementation of the actions decided at the MT
during the Quality Management Review. A record of the monitoring is
kept.
3.2 On MT request the QM reports on progress of the implementation.
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Public
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Standard Operating Procedure

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Standard Operating Procedure

Quality Management Review

Scope The evidence based annual review by EFSA’s Management Team of

Special This procedure is a controlled document maintained by Quality

Responsibilities • EFSA Management Team: perform the quality management review

Abbreviations and definitions

Quality Management Review

Quality Management Review

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