Wednesday, February 25, 2009

Pointers Inspectors look for during FDA inspection - For CAPA (QSIT)

  1. see that corrective action taken to correct existing product nonconformity or quality problems and Prevent recurrence of the problem
  2. The corrective action should Include explanations for how the firm will meet the requirements for all elements of the CAPA subsystem
  3. Gain working knowledge of the firm's CAPA procedure before beginning evaluation of this subsystem
  4. Have management provide definitions
  5. 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
  6. Assure the firm has procedures that describe/require input of product/quality problems into the CAPA system.
  7. Analyze product/quality problems to identify those that may require corrective action.
  8. 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
  9. Determine if the firm is identifying product and quality problems that may require a preventive action
  10. Review if preventive actions have been taken regarding unfavorable trends recognized from the analysis of product and quality information.
  11. Determine if the firm is capturing and analyzing data regarding in-conformance product.
  12. Select one or two quality data sources
  13. Review records to confirm data was entered into CAPA system
  14. Determine whether data is Complete ,Accurate ,Entered into CAPA system in timely manner
  15. Determine which statistical and non-statistical techniques are used
  16. Confirm comparison of problems and trends across different data sources to establish a global, and not an isolated view, of a problem.
  17. 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
  18. 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
  19. Discuss with the firm their rationale for determining if CAPA is necessary for an identified trend of product/quality problems.
  20. Select failure investigation records of more than one failure mode and determine if the firm is following their failure investigation procedures.
  21. Confirm that all sampled failure modes have been captured within data summaries
  22. Determine whether the depth of investigation is sufficient to determine the corrective action necessary to correct the problem.
  23. Review incomplete failure investigations for potential unresolved nonconformances and possible distribution of nonconforming product
  24. Review records of nonconforming product where the firm concluded CAPA was not necessary.
  25. Review nonconforming product and quality concessions
  26. Review controls for preventing distribution of nonconforming products.
  27. Review records of the most recent corrective/preventive actions
  28. Determine if corrective/preventive actions for product/quality problems and changes have been documented and implemented
  29. Determine that information regarding quality problems and CAPA has been submitted for management review
  30. Confirm that there is a mechanism to disseminate CAPA information to those directly responsible for assuring product quality and the prevention of quality problems

How to be one step ahead of FDA inspectors and what to do to show what they want to check attend the training

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