CAPAプロシージャ - 是正措置プロセス


A Corrective Action Procedure is the 'Plan of Action' Once a Nonconformance is Detected and to Lead a Corrective Action Process

A corrective action process must eliminate a nonconformity or other undesirable situation (ISO 9000:2000, clause 3.6.5). In effect, the CAPA procedure is the 'plan of action' once a nonconformance is detected.

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Corrective Action Process and CAPA Procedures

CAPA (Corrective Action / Preventive Action) is often used synonymously with 'corrective action procedure'. A CAPA -- the overall effort to investigate and correct quality issues to prevent recurrence -- is the lynchpin of any quality system. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a corrective action procedure improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

Steps in a Corrective Action Process

A corrective action process is not reworking or remaking an item to bring it back into specification. Patching up a mistake doesn't address what made it happen in the first place and it won't prevent a recurrence.

A CAPA procedure can be documented using either a paper or electronic system. Either way, the process is basically the same:

  • Document that was specified versus one that was found. Check the functional specifications and any other requirements against the actual result.
  • Determine how much time should be allowed for a corrective action process (or CAPA response).
  • Decide who will investigate the problem, find a solution and perform the corrective action procedure.
  • Research and document the cause of the problem.
  • Plan how to keep the problem from recurring.
  • Communicate the corrective action process to everyone involved, at each appropriate level.
  • Periodically check to ensure the problem is solved and that the corrective action procedure was effective.

Automating the above steps greatly facilitates the completion of the CAPA process.

How Can MasterControl's CAPA Process & Procedure Help?

MasterControl CAPA automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of entire corrective action procedures, while providing a secure, centralized, and web-based repository for all CAPA documents.

For More Information on Corrective Action Procedures & CAPA Process

For more information about the corrective action procedure and corrective action process (or CAPA), please feel free to contact a MasterControl representative.