- see that corrective action taken to correct existing product nonconformity or quality problems and Prevent recurrence of the problem
- The corrective action should Include explanations for how the firm will meet the requirements for all elements of the CAPA subsystem
- Gain working knowledge of the firm's CAPA procedure before beginning evaluation of this subsystem
- Have management provide definitions
- Assure that there is a method for identification and input of quality data into CAPA system, including information regarding product/quality problems that may require corrective and/or preventive action
- Assure the firm has procedures that describe/require input of product/quality problems into the CAPA system.
- Analyze product/quality problems to identify those that may require corrective action.
- Confirm the firm is routinely analyzing data from
–Acceptance activities relating to component, in-process and finished device testing
–Information obtained subsequent to distribution: complaints, service activities, returned products
–Information relating to concessions, quality records, and other sources of quality data
- Determine if the firm is identifying product and quality problems that may require a preventive action
- Review if preventive actions have been taken regarding unfavorable trends recognized from the analysis of product and quality information.
- Determine if the firm is capturing and analyzing data regarding in-conformance product.
- Select one or two quality data sources
- Review records to confirm data was entered into CAPA system
- Determine whether data is Complete ,Accurate ,Entered into CAPA system in timely manner
- Determine which statistical and non-statistical techniques are used
- Confirm comparison of problems and trends across different data sources to establish a global, and not an isolated view, of a problem.
- Confirm that the full extent of a problem is captured before the probability of occurrence, risk analysis and the appropriate corrective or preventive action can be determined
- Review procedure for conducting failure investigations
–Determine if the procedure includes a) Provisions for identifying failure modes b) Determining significance of failure modes c) Rationale for determining if a failure analysis should be conducted as part of the investigation
- Discuss with the firm their rationale for determining if CAPA is necessary for an identified trend of product/quality problems.
- Select failure investigation records of more than one failure mode and determine if the firm is following their failure investigation procedures.
- Confirm that all sampled failure modes have been captured within data summaries
- Determine whether the depth of investigation is sufficient to determine the corrective action necessary to correct the problem.
- Review incomplete failure investigations for potential unresolved nonconformances and possible distribution of nonconforming product
- Review records of nonconforming product where the firm concluded CAPA was not necessary.
- Review nonconforming product and quality concessions
- Review controls for preventing distribution of nonconforming products.
- Review records of the most recent corrective/preventive actions
- Determine if corrective/preventive actions for product/quality problems and changes have been documented and implemented
- Determine that information regarding quality problems and CAPA has been submitted for management review
- Confirm that there is a mechanism to disseminate CAPA information to those directly responsible for assuring product quality and the prevention of quality problems
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