Documentation Review Process in GMP Audits

When conducting an audit, the auditor should first assess the company documentation against the related reference documents. Any findings would then be against company documentation or the quality management system. Then the auditor should match employee actions and records (performance) against what is stated in their own internal documentation. Any findings noted would be against performance of actions as required.

In other words, if during the documentation review, a performance standard is found to be missing or in violation of a reference standard, then a nonconformance is written against the reference standard. If observed actions aren’t as documented, then a nonconformance is written against the internal document or performance standard . This methodology avoids the confusion of citing multiple sources when referencing a single nonconformance. By having a structured, internal audit program with trained auditors and regularly scheduled audits, an organization can verify that it is working in a manner that will produce a product or service that meets customer needs and expectations.