Management Review is all about reviewing the available data to confirm that adequate resources are present to ensure customer satisfaction and improve the QMS and the product. According to the Code of Federal Regulations (CFR), section 21 CFR 820.120(c) 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 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.
A company was recently cited for:
….. Procedures for management review have not been adequately established.
Specifically, your firm conducted its only Management Review meeting one week prior to this inspection. According to the VP of Operations, all aspects of the Quality System had been evaluated and were compliant. However,
a. Quality System records were not defined. For example, none of the quality system records have a space allocated to document the date in which activities were conducted.
b. Quality System procedures were not implemented. For example, complaint procedure states that all complaints will be documented on the Customer Complaint form (Form…) but oral complaints are documented in a notebook by your Warehouse employee and do not include all required information.
c. Lack of resources not evaluated. For example, your VP of Operations stated …This was a discussion about your firm allowing the personnel who have direct responsibility for a matter being the auditor of the same subject.
d. There is no Management Review procedure in place.
For more information on management review and what FDA expects to see refer to FDA Inspection Manual Management Controls.
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