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Audit Initiation - The Quality Auditor prepares/updates an audit checklist for systematic examination of the area to be audited, informs the Manager of the department being audited at the start of the audit, and reviews observations with the Department Manager.

(21 CFR Part 820.180(b) relates) (21 CFR Part 211.110(c) relates)There must be a system in use that ensures all complaints about marketed products are promptly and diligently examined and the causes of quality defects investigated. (21 CFR Part 211.198(a) relates)Where statistical analysis is used to verify the acceptability of a process capability, then there must be documented validation of the robustness and accuracy of this analysis procedure. (21 CFR Part 211.160(a) relates).- For successful online validation the Quality Auditor (team leader) must review all applicable change control records subsequent to a design transfer, any FDA clearance delay information, recall records, standard manufacturing procedures, device histories, complaint history, device labels and inserts, previous audits with results, follow-up audits, plus any other document relative to the online validation audit.

Included in the correction schedule shall be the responsible individual, and the date when corrective action will be completed.

The Manager of Quality Assurance shall act as arbiter, if necessary, to judge validity of the deficiency, responsible individual, and reasonable date to complete the corrective action.

Issuance of Audit Report - The Quality Auditor issues the written audit report to the President and Department managers within three working days following completion of the audit.

If conditions are critical, the Director of Quality Assurance shall verbally brief appropriate staff members within 12 hours following audit completion. Corrective Action - The appropriate Management staff member shall be responsible for developing a schedule for correcting deficiencies cited in the audit report and submitting same within five working days to the Quality Assurance Manager.

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