x17audit.docVIP

17 QUALITY SYSTEM AUDITS INTRODUCTION 17-1 AUDIT REQUIREMENTS 17-2 Procedure 17-2 Audit Schedule 17-4 Independent Auditor 17-4 Employee Training 17-4 Evaluation Criteria 17-5 Results and Corrective Actions 17-5 Audit Certification 17-6 EXHIBITS 17-7 Policy/Procedure for Quality System Audit 17-8 Quality System Audit Procedure 17-14 Vendor Survey Form 17-17 INTRODUCTION Section 820.20 outlines the quality system requirements of the Quality System (QS) regulation. As discussed in Chapter 2, every quality system should include: management policies; objectives; an organization; documentation; performance of tasks according to policies; monitoring of the system (feedback) and corrective action as indicated by the feedback. Section 820.22 requires that the quality system be monitored through audits. The analysis and use of feedback data from product acceptance, audits, complaints, repairs, and other sources are necessary parts of a self correcting quality system. Thus, the audit of a quality system is one of the most important GMP requirements. The quality system first implemented by a new manufacturer will change as the manufacturer grows and as the company’s products, operations and employees change. Therefore, a quality system should change with the company. Quality system audits are the primary tool for assuring that the quality system changes are correct and are correctly implemented. A quality audit is a documented independent inspection and review of a quality system. The audit is performed on a periodic basis in accordance with written procedures. The objective is to verify, by examination and evaluation of objective evidence, the actual degree of compliance with those elements of the quality system under review. These audits are an essential part of every medical device manufacturers effort to assure safe and effective devices. Regardless of how well a quality system is planned, monitoring of the system is required if the quality system prog