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Guide to Inspections of Medical Device Manufacturers
December 1997

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  1. Components - 21 CFR 820.50 and 820.80
  2. A determination should be made as to whether the firm is or may be producing nonconforming devices by using nonconforming components.

    There are several ways of making this determination:

    1. Review of complaints, service and failure investigation documents show root causes of defective devices determined to be nonconforming components.
    2. Review of temporary authority (deviation authority) or other documents authorizing the use of nonconforming components.
    3. Determine if the firm is using appropriate statistical rational and technique for acceptance sampling and testing of components.
    4. Particular attention should be paid to custom components and those components that would require special handling or storage to maintain their integrity. Be wary of situations where a manufacturer has relaxed specifications because the supplier could not meet the original specifications.
    5. Determine if the test and/or screening parameters used for component acceptance based only on certificate of conformance will produce devices meeting finished product specifications.
    6. Where a manufacturer uses Just In Time (JIT) component acceptance, and relies on component vendor audits in place of incoming component inspection, review the manufacturer's audit schedule and audit procedures. Pay special attention to the vendor's rejection rate.
  3. Quality Audits - 21 CFR 820.22
  4. The quality audit is the foundation of the quality assurance program. Determine if the manufacturer has a written procedure for conducting quality audits and how often these audits are conducted. It is recommended that the time between audits not exceed a 12-month period. More frequent audits may be recommended if the firm has a serious GMP problem.

    The agency's policy relative to the review of quality audit results is stated in CPG 7151.02. This policy prohibits FDA access to a firm's audit results. Under the QS/GMP, this prohibition extends to reviews of supplier audit reports and management reviews. However, the procedures and documents that show conformance with 21 CFR 820.50, Purchasing Controls, and 21 CFR 820.20(3)(c), Management Reviews, are subject to FDA inspection.

    Quality audits should consist of a formal, planned check of all elements in the quality system. They are NOT product audits. Such audits must be conducted using adequate detailed written procedures by appropriately trained individuals. If conducted properly, a quality audit can detect program defects and, through isolation of unsatisfactory trends and correction of factors that cause defective products, prevent the production of unsafe or nonconforming devices. Without an effective quality audit function the quality system is incomplete and there is no assurance the manufacturer is consistently in a state-of-control.

    Evidence of inadequate auditing may exist without gaining access to the written audit reports. This evidence may be obtained by relating the audit program to deficiencies observed in complaint files, change control and/or calibration, or other problems in quality systems. If significant quality system problems have existed both before and after the firm's last self audit, then you should critically review the written audit procedures. The audit procedures should cover each quality system, and should be specific enough to enable the person conducting the audit to perform an adequate audit. The auditors must be adequately trained. If it is possible to interview an auditor, ask how the audits are performed; what documents are examined; how long audits take; etc.

    Audits should be conducted by individuals not having direct responsibility for matters being audited. In one-person and very small firms, where hiring an outside auditor to meet this requirement would be impractical or overly burdensome, self-audit may be acceptable and the auditor need not be independent. Consult with CDRH or the Division of Emergency and Investigational Operations as necessary. If there are significant FDA-483 observations, and independent audits are being performed, but deficiencies are apparently not being identified by the auditor, then an FDA-483 should contain an observation indicating a lack of adequate audits

    Determine whether corrective action by upper management is being taken. Auditors may be asked if they observed any of the ongoing GMP deficiencies during their prior audits (ongoing GMP deficiencies may also be identified by reviewing prior FDA-483's). If the answer is yes, check the written audit schedule, if available, to determine if follow up audit is scheduled for the deficient areas. Also, check the written audit procedure for instructions for review of audits by upper management, and re-audit of deficient areas. A failure to implement follow-up corrective actions, including reaudits of deficient matters may be listed as a GMP deficiency on the FDA-483.

    NOTE: Reaudits of deficient matters are not always required, but where one is indicated, it must be conducted. The reaudit report should verify the recommended corrective action(s) was implemented and effective.

    The QS/GMP regulation (21 CFR 820.180(c)) requires a manufacturer to certify in writing, whenever requested to do so by an Investigator, that audits and reaudits have been conducted. You should consult with CDRH (HFZ-305) through your supervisor/team leader, etc. prior to requesting such certification.

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