shr-Auditform.docVIP

SUPPLIER QUALITY SYSTEM AUDIT FACILITY AUDITOR: Name: Date: Address: Telephone: Fax: PRINCIPAL PRODUCTS and/or SERVICES BACKGROUND INFORMATION Company Owner: FDA Registration #: Last Audit: Last FDA Audit: Size of Building: Construction Type: Building Age: Number of Employees: Number in Manufacturing: Number in QA: PERSONNEL PRESENT DURING AUDIT 4.1 MANAGEMENT RESPONSIBILITY GMP 820.20 GMP 820.186 1. Is there a documented quality policy? 2. Are policies understood, implemented, and maintained at all levels of the organization? 3. Is there a management representative who has defined authority and responsibility for implementation and maintenance of the quality systems? 4. Are the organizational structure, responsibilities, and authority of management personnel documented? 5. Is there a documented organization chart? Please attach 6. Does upper management periodically review and approve all aspects of the quality system to ensure its continuing suitability and effectiveness? 7. Is there a documented process for these reviews? 8. Are there documented records of the reviews? 4.2 QUALITY SYSTEM GMP 820.50 GMP 820.186 9. Is there a documented quality manual? 10. Have all processes affecting product quality/performance been identified and controlled? 11. Are there records to demonstrate the objectives of the quality system - responsibilities - authorities - quality system procedures/work instructions? 4.3 CONTRACT REVIEW 12. Is there a documented procedure for the placement of orders? 13. Are contractual requirements adequately defined and documented? 14. Have any differences with supplier/c