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eQMS para Ciências da Vida 18 itens

CAPA Management Checklist (21 CFR 820.100 / ISO 13485)

Este checklist está em inglês.

Verifies that corrective and preventive action records are properly investigated, actioned, verified for effectiveness, and closed. Use for CAPA file review and quality system audits.

21 CFR 820.100ISO 13485:2016ICH Q10

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Problem Identification and Sources

  • Is the CAPA source documented (complaint, NCR, audit, trend, deviation, etc.)? *
  • Are quality data sources analyzed to identify existing and potential nonconformities? *
  • Is a clear problem statement recorded? *

Investigation and Root Cause

  • Was the cause of the nonconformity investigated? *
  • Is a structured root cause method (5-Why, fishbone, FMEA) documented? *
  • Is the extent/scope of the problem assessed, including other affected lots or products? *

Action Plan

  • Are corrective actions defined to eliminate the identified root cause? *
  • Are preventive actions defined to prevent recurrence where applicable? *
  • Are responsibilities and due dates assigned for each action? *
  • Record the target completion date for the CAPA.

Risk and Change Assessment

  • Is the CAPA action commensurate with the risk of the nonconformity? *
  • Were required changes to documents, processes, or the risk file identified and controlled? *

Effectiveness Verification

  • Were corrective/preventive actions verified or validated before implementation to confirm they do not adversely affect the device? *
  • Is objective evidence of effectiveness collected after implementation? *
  • Was the effectiveness check successful (no recurrence)? *

Communication, Review, and Closure

  • Was relevant information disseminated to those responsible for assuring quality and to management review? *
  • Are all CAPA activities and results documented in the CAPA record? *
  • Approver sign-off for CAPA closure. *

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