Contents

14. Quality Assurance Reporting

Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs

This section provides a formal mechanism for reporting to management the status of the QA program.

Step 1 A QA representative generates a QA report (at least annually) that addresses the following minimum elements as applicable:

• results of self-assessment activities (TSAs, MSAs, DQAs, PEs)
• results of external audits, assessments, and surveillances
• regulatory compliance issues
• significant QA problems and recommended solutions
• evaluation of items, services, and processes needing improvement
• trends (see Section 13, Corrective Action and Quality Improvement).
• identification of the report preparer.

Note: If the annual MSA covers the above, then no additional reporting is required.

Step 2 The representative provides the QA report to the project manager and/or laboratory manager. The manager(s) determine whether additional distribution is appropriate.