VI.13.1 Purpose
The purpose of this procedure is to outline a system of quality audit to ensure that concerned departments to maintain constant quality level exactly follow the established quality systems.
VI.13.2. Application
This procedure applies to all areas within the company and to all the suppliers and subcontractors.
VI.13.3. Procedure
13.3.1. Quality Assurance Department is responsible for quality audit planning and conducting.
13.3.2. The audit shall include an evaluation of the production methods, workmanship, adequacy, completeness, and correctness of the documentation, and the effectiveness of the inspection and test process, procedure or standards.
13.3.3. At least once a month, an quality audit of senior management shall be held, the results of audit and items which do not conform to the detected during the audit shall be presented to the area supervision, corrective action plan shall be initiated immediately.
13.3.4. At least once a year, a management review meeting shall be held to discuss the whole plan of quality and manufacturing improvement and the effectiveness of the overall quality program.
13.3.5. The quality manual shall be immediately revised to reflect any procedure change when the completion of quality system review is conducted.
13.3.6. An audit shall be conducted by Quality Assurance supervisor or manager at least every three (3) months at the following areas;
PRODUCTION / ENGINEERING / PURCHASING / WAREHOUSE / QUALITY ASSURANCE / CALIBRATION / FINANCE
13.3.7. The audit results will be published to Manufacturing, Engineer, Materials, Finance or other related departments for review and corrective action taken.
13.3.8. All nonconformance found during audit shall be highlighted in the audit report along with the required course of corrective action to ensure future conformance.
13.3.9. Any department, which fails the audit, will undergo a monthly audit until conformance is attained.
13.3.10. The quality Assurance Department is responsible for planning and conduction quality audit of suppliers and subcontractors and determining the necessity of initiating the request for corrective action plan.
13.3.11. Quality Assurance Department is responsible for supplying the completed report to the suppliers and subcontractors
13.3.12. The audit shall periodically follow-up on supplier corrective action implementation to verify compliance.
