820.22 Quality audit.

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. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.

Interpretation:

The quality system must be evaluated.  The Internal Quality audit is used to demonstrate this effectiveness.  Whenever a deficiency is found a Corrective Action Request (CAR) should be issued to the person responsible for that area.  The CAR should have the details of the finding, the date of the finding and the person responsible for the area.  A corrective action is requested and a date for the correction should be given.  Once the CAR is completed the audit action item must be officially closed out.  The corrective action should be evaluated at future audits to ensure effectiveness.

The auditor doing the audit should not have direct responsibility for the area being audited.  There are have been many false notions that “everyone is responsible for quality” and hence the issue of direct responsibility isn’t as critical when conducting audits.  It is recommended that you do not deviate from the FDA’s policy.  Some organizations with a small number of personnel may find it useful to subcontract out to a third party to conduct the audit.  If your organization takes this path make sure you follow the FDA’s policy on subcontracting.

 *** for more extensive look ---- Download our 328 page guide to Interpretation of FDA's QSR with QSIT Reference!

Reference: www.FDA.gov

The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation.