Quality system audits

Figure 17.2 Internal quality system audit process...

Auditors should select the audit method most appropriate for their intended audit purpose. Initial quality system audits or regularly scheduled audits are likely candidates for the top-down approach, while audits conducted as part of a root cause analysis, for example, may best employ a bottom-up approach. The FDA employs a similar approach to inspections. Regular scheduled biennial inspections are more likely to employ a top-down methodology. For cause inspections conducted in response to a specific product issue such as a recall are more likely to employ a bottom-up approach. FDA investigators may employ a combination approach during biennial inspections if investigators are aware of specific quality problems that they wish to include in the inspection. 

Company Name] Quality System Audit Checklist ... 

A person who is qualified and authorized to perform all or any portion of a quality system audit is an auditor. 

ISO 10011-1 1990, Guidelines for Auditing Quality Systems — Part 1 Auditing. ISO 10011-2 1991, Guidelines for Auditing Quality Systems — Part 2 Qualification Criteria for Quality Systems Auditing. 

March 28, 1994 WL Same issues as Oct. 1993 + incomplete quality system audits. 

The excipient manufacturer should carry out a comprehensive system of planned and documented internal quality audits to verify whether quality activities comply with planned arrangements and to determine the effectiveness of the quality system. Audits should be scheduled on the basis of the status and importance of the activity. The audits and follow-up actions should be carried out in accordance with documented procedures. 

The Standard considers that an effective quality system should comprise management responsibility quality system principles quality system audits quality/cost considerations raw material quality control inspection and testing control of non-conforming product handling, storage, packaging and delivery after sales service quality documentation and records personnel training product safety and liability and statistical data/analyses. 

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