ED Decision 2015/029/R
1. Procedures should be held current such that they reflect best practice within the organisation. It is the responsibility of all employees to report any difficulties with the procedures via their organisation’s internal occurrence reporting mechanisms.
2. All procedures, and changes to the procedures, should be verified and validated before use where practicable.
3. The feedback part of the system should address who is required to rectify any non-compliance in each particular case and the procedure to be followed if rectification is not completed within appropriate timescales. The procedure should lead to the accountable manager specified in M.A.706.
4. The independent quality audit reports referenced in AMC M.A.712(b) should be sent to the relevant department for rectification action giving target rectification dates. Rectification dates should be discussed with such department before the quality department or nominated quality auditor confirms such dates in the report. The relevant department is required to rectify findings and inform the quality manager or the quality auditor of such rectification.
5. The accountable manager should hold regular meetings with staff to check progress on rectification except that in the large organisations such meetings may be delegated on a day to day basis to the quality manager subject to the accountable manager meeting at least twice per year with the senior staff involved to review the overall performance and receiving at least a half yearly summary report on findings of non-compliance.
AMC M.A.712(a) requires current procedures, employee reporting of difficulties, verification of changes, and a feedback system leading to the accountable manager. Audit reports go to departments with agreed rectification
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