Availability of QA plan: What is required for auditors?

• A. QA plan and SOPs should be readily available; Pa.-accredited labs have a Quality Manual as their QA plan
• B. QA documents should be kept secret
• C. Only the QA manual is required
• D. Documents are available only upon request at audit time

Answer: (A)

Auditors need to verify that the lab operates under a documented, accessible quality system that guides how work is performed and how quality is ensured. This requires a QA plan that outlines the overall quality framework plus the SOPs that provide the step-by-step procedures for each activity. When these documents are readily available, the auditor can quickly review processes, controls, and record-keeping to confirm compliance. In Pennsylvania-accredited labs, the Quality Manual often serves as the QA plan, reinforcing that the plan and the supporting SOPs together form the accessible basis for the audit. Keeping documents secret, or making them available only on request or focusing only on the QA manual without the procedures, would impede the audit and fail to show how work is controlled and quality is maintained.