A notable FDA 483 observation from our recent GMP Trends Issue 1156 has revealed multiple instances where a company’s internal audit procedures failed to maintain the fundamental principle of auditor independence, a cornerstone of effective quality management systems.
The 483 reads:
Specifically, the SOP…, “Internal Audit Procedure”, states “Auditors shall be independent of the area and not have responsibility for matters being audited”. Five occurrences of auditors conducting areas in which they have direct responsibility was observed in your firm’s Internal audits, conducted over the last four years. For example:
a. The Management Representative audited the Management Responsibility area
B. The Management Representative audited the Design Control area, during this time the Management Representative was assigned as the Quality Engineer for the Class II … as indicated on the Design Plan.
c. The Production Team Leader audited the Risk Management area and the Monitoring and Measurement of Product area.
d. The Design Assurance Engineer audited the Design and Development area.
The independence of auditors is essential for ensuring that audits are conducted objectively and that any findings are credible. When auditors are involved in the areas they are auditing, it can lead to a conflict of interest that reduces the overall effectiveness of audits. Even in the most perfect and honest scenarios, auditors may unconsciously overlook deficiencies if they are inspecting their own department.
Internal audits are an opportunity to develop cross-functional teams, allowing personnel to accrue knowledge of different departments and systems. Collaboration concerning the findings of the audit will strengthen the overall quality system. The principle of auditor independence isn’t merely a bureaucratic requirement – it serves as a critical safeguard ensuring objective evaluation of systems and processes.
FDA expectations are outlined in 21 CFR 820.22 with the key phrase reading “Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.”
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A previous GMP Trends blog post, “Annual Product Reviews” features a similar theme of teamwork, highlighting the importance of cross-functional teams at a firm.
