Internal Quality Audit

A medical device company should have a robust internal quality audit program which consists of procedure, team, plan, quality audit checklist to audit the quality system regularly.

For quality audit plan:  Quality Assurance (QA) should be responsible for the planning and scheduling of internal audits of the quality system, manufacturing processes and products. QA should establish audit frequency. The audit frequency is often based on the importance of manufacturing processes, products and areas. Should there be customer complaints, internal and external nonconformities regarding a product and process, internal audit for that area of interest should be carried out.

Internal audit should be performed at the very least once a year or semiannually or quarterly.

The internal quality audit plan should be mapped out clearly in a matrix with all the quality system elements like that of 21 CFR 820 and ISO 14971. In this plan, there should be responsible group who will be performing the internal audit on the desired date of the audit.

The audit team should consist of qualified, experienced and independent quality auditors who are very well versed in the quality system about to be audited.

During the audit, auditors seek objective evidence demonstrating whether the audited activities conform to the requirements of the documented quality system, and whether the system is effectively implemented and maintained. When nonconformity is noted, it is brought to the attention of, and discussed with, the responsible individual of the department in question.

Before the end of the audit, each noted nonconformity is documented using the Audit Nonconformity Report form. Auditors fill out only the first part of the form, describing the noted nonconformity. The form is then handed over to the responsible individual who uses its second part to propose a corrective action.

Documentation and record: Internal audits, implementation of resulting corrective actions, and follow-up audits are documented using the audit nonconformity report form.

At the end of an auditing cycle, all nonconformity reports established during the cycle are compiled and analyzed, and are presented at the management review meeting.

The following is the exact working from FDA website.

820.22	Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.
820.22	Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.
820.22	Corrective action(s), including a re-audit of deficient matters, shall be taken when necessary.
820.22	A report of the results of each quality audit, and re-audit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited..
820.22	The dates and results of quality audits and re-audits shall be documented

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.