FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Key Elements for a Successful Internal Audit

May 4, 2017
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Responses to internal audit reports are critical for GMP compliance because they fall under CAPA — so how a company responds to the findings of an internal audit is a key component of an effective audit.

Internal audit SOPs should reference existing CAPA procedures, explains a new FDAnews report on internal auditing, which explores the key elements for a successful audit and how best to respond to an audit’s findings.

It’s important not to view the internal audit as a “blame and shame” exercise. Many companies struggle with how to avoid situations where the manufacturing site, department or a specific operation is hiding things from the auditor. Internal audits can also help with employee training and identification of gaps.

Department managers shouldn’t try to protect their staff from internal auditors, but should allow them free access so each side learns from the other. The auditees need to freely share all pertinent information about their operations, while auditors openly share their observations.

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