According to the Code of Federal Regulations (21 CFR 820.20 Management Responsibility), Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented. The management will review items such as, results of audits, customer feedback, process performance and product conformity, status of previous CAPA, follow-up actions from previous management reviews, changes that could affect the quality management system and recommendations for improvement.
The outcome from the management review should include any decision and actions related to: improvement of the effectiveness of the quality management system, improvement of product related to customer requirements and any resources needed to meet these objectives.
A company recently received the following observation:
…. The results and/or dates of management reviews are not documented.
Specifically, your firm has failed to document the attendees, dates, and results of Management Reviews.
a. I asked the Vice President if I could see the sign-in sheet from their Management review, after reading the firm’s SOP …, “Management Review and Responsibility Procedure”. He explained that he regularly meets with the President, but when doing so he does not document or create sign-in sheets for the meetings, which does not follow the procedure.
b. In addition, I asked the Vice President if he and the President discuss such things as the nonconformances, CAPAs, RGAs, complaints, or other items during their phone conversations (which the Vice President said were meetings). He explained that they discuss the items if they come up, but these discussions and/or the results of the discussions are not documented, which does not follow the procedure.
For additional information on how to implement Management Review, refer to FDA presentation: Management Review to Drive Quality and Business Improvement. For information on what FDA will review during an inspection, refer to FDA Inspection Guide: Management Controls.
For more observations pertaining to quality systems, see our new Issue 1124 available today. It also has observations pertaining to manufacturing controls, data integrity and medical devices.
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