Quality auditing is the systematic examination of a quality system and audits form an important part of Good Manufacturing Practice (GMP). Auditors need to be knowledgeable about cleanroom operations, and have an understanding of microbial contamination as well as being trained specifically as auditors. Ideally, they should have complete independence from the functions they are auditing.1
The audit approach within GMP is designed to verify objective evidence of processes and to provide evidence of action to eliminate or reduce problem areas. Quality auditing should not only report non-conformances and corrective actions, it should also highlight areas of good practice. Risk assessment plays an important part because one aim of the audit is to assess vulnerability. Risk assessment tools are available to the auditor to help structure the audit. These include approaches such as Failure Modes and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).2
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