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820.100
Corrective and preventive action.
(a) Each
manufacturer shall establish and maintain procedures for implementing
corrective and preventive action. The procedures shall include requirements
for: (1) Analyzing
processes, work operations, concessions, quality audit reports, quality
records, service records, complaints, returned product, and other sources of
quality data to identify existing and potential causes of nonconforming
product, or other quality problems. Appropriate statistical methodology shall
be employed where necessary to detect recurring quality problems; (2)
Investigating the cause of nonconformities relating to product, processes,
and the quality system; (3) Identifying
the action(s) needed to correct and prevent recurrence of nonconforming
product and other quality problems; (4) Verifying
or validating the corrective and preventive action to ensure that such action
is effective and does not adversely affect the finished device; (5)
Implementing and recording changes in methods and procedures needed to
correct and prevent identified quality problems; (6) Ensuring
that information related to quality problems or nonconforming product is
disseminated to those directly responsible for assuring the quality of such
product or the prevention of such problems; and (7) Submitting
relevant information on identified quality problems, as well as corrective
and preventive actions, for management review. (b) All
activities required under this section, and their results, shall be
documented. Interpretation:
This section requires an analysis of problem data,
returned product, and an investigation of non-conforming product. Also
820.198 requires an investigation of complaints that allege a device does not
meet specifications. Section 820.100 refers to analysis of processes, work
operations, concessions, quality audit reports, quality records, service
records, complaints, returned product, and other sources of quality data to
identify existing and potential causes of nonconforming or other quality
problems. Section 820.198 also involves reviewing and evaluating complaints
to determine whether or not an investigation is necessary. All these
activities and their results shall be documented. Some devices have a specified requirement for
servicing. If this is the case, the manufacturer shall establish and maintain
instructions and procedures for performing and verifying this servicing
(820.200). The servicing reports shall also be analyzed using 820.100,
Corrective and Preventive Action; if the servicing involves a death or
serious injury, the service report is considered to be a complaint per
section 820.198, Complaint Files, and is reported to FDA per parts 803 and
804, Medical Device Reporting. The significance of the device and any hazard the
defective device presents should be taken into consideration when determining
compliance with corrective and preventive action requirements. Analysis shall
be taken to the level necessary to determine the actual failure mechanism,
e.g., defective component, incorrect raw material, erosion, composition, etc.
The cause of failure is obvious in some cases and a formal investigation may
not be needed. A record of the investigation, follow up, and conclusions
shall be made in accordance with section 820.100. When a systematic failure has been diagnosed,
manufacturers need not analyze every device with the same diagnosed symptoms.
However, enough devices should be analyzed to clearly establish symptoms
before any assumptions are made about the cause of failure or about
corrective actions. When an investigation results in identification of a
deficiency, such as a failed component or a design flaw, and this deficiency
may exist in other product lines, the investigation will not be effective
unless it extends to determining the effect on other product lines. If the failure is design related, the design shall be corrected per the design control requirements in 820.30 in order for the devices to meet company quality claims and not be adulterated under the FD&C Act section 501(c). When a failure is determined to be related to documentation, assembly, processing, labeling, testing, packaging, or other manufacturing operations, the manufacturing deficiency shall be identified, corrected, and documented.
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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. |
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