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Author: 

 Corrine Bonfiglio

Internal quality auditing is the cornerstone of an effective quality system and applicable to both FDA 21 CFR 820, Quality System Regulation, and ISO 13485:2003, Medical Devices – Quality Management Systems. The purpose of internal quality auditing is to ensure that the quality system has been implemented effectively and to identify and address problems in a timely manner. All areas of a quality system should be audited at least annually with problem or critical areas audited more frequently based on risk to the product or process being audited.

Your internal quality audits should be the most important audits for your organization. Consistent, thorough auditing practices will ensure that your organization finds problems (or potential problems) in your quality system and fixes them before the regulatory agency investigators find them. FDA specifically states in its Quality System Inspection Technique (QSIT) manual that FDA investigators, finding deficiencies not being identified by the company’s internal audits, should include an observation on the FDA-483 that there is a lack of adequate audits.

Internal quality audits should be conducted by personnel that have sufficient auditing experience (documented in their training file) and knowledge of the quality system regulations, ISO standards and guidance documents relevant to the industry and product to perform a thorough, relevant audit. Audit experience can be gained by attending training courses that provide the fundamentals of good auditing practices; however, actual hands-on audit experience, by working alongside experienced auditors, for example, is the best way to learn how to interpret the regulations and apply them while auditing. While QA personnel are most often the internal auditors by default, many organizations choose to cross-train personnel from all areas of the organization, including but not limited to R&D, manufacturing, and purchasing. Cross-training is important because auditors must be independent of the areas they are auditing, i.e., if QA is responsible for the internal audit program, then QA cannot audit this area of the quality system.

In a large organization, there is usually a sufficient pool of potential auditors that can be trained to perform the internal quality audits. In smaller organizations, however, this is more difficult because personnel are often responsible for multiple areas. Smaller organizations or any organization looking for a truly independent, in-depth audit should consider using an external quality system expert. Expert consultants not only bring the required independence to your audit program but can also offer a broader view of accepted industry practices and that “second opinion” to get your quality system into full compliance.

Important elements of an effective auditing program include:

• A Standard Operating Procedure (SOP) describing the internal audit activities, timelines and deliverables.

• An audit plan that describes the scope of the audit and the documentation that will be reviewed and referenced during the audit, including applicable regulations, standards, guidance documents, SOPs, work instructions, labeling specifications, and so forth.

• An audit checklist that will serve as an outline of the areas to be covered, questions asked along with the responses and evidence reviewed.

• An audit report that includes not only audit findings but opportunities for improvement and activities that are being done correctly. Audit findings should be prioritized using risk assessment techniques and Corrective Actions initiated for the higher risk findings.

It is important to remember that it is FDA’s policy not to review internal audit reports; however, it will look for evidence that an internal audit program has been implemented and that internal audits are conducted. Notified Body auditors do have full access to the internal audit reports.

A well-defined, implemented internal quality audit program is essential to maintaining an effective quality system and prepares the organization for the inevitable regulatory agency inspections. Seeking outside quality system experts to perform an independent internal audit is a good way to ensure that the current audit program is effective and reflects current industry practices.

Corrine Bonfiglio is a Senior Regulatory and Quality Consultant with Noblitt & Rueland and has over 20 years of accomplished quality assurance, regulatory and clinical affairs experience. Find out more about Noblitt & Rueland by visiting the company listing on .

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