CAPA Process and Procedure

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

MasterControl's CAPA Procedure - Corrective Action Process Systems are designed by industry practitioner for automating the CAPA process in any organization. A CAPA system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated CAPA system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

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Simplify CAPA in 7 Steps

CAPA Videos

Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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CAPA Procedures and Process

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.

Free CAPA Process Resources

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Data Sheet: MasterControl CAPA
Industry Brief: Simplify CAPA in 7 Steps Industry Brief: The 4 Phases of CAPA Maturity: A Guide to Mastering Quality Event Management

Steps in a CAPA Process

A CAPA 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 root cause of the problem.
Plan how to keep the problem from recurring.
Communicate the CAPA process to everyone involved, at each appropriate level.
Periodically check to ensure the problem is solved and that the CAPA procedure was effective.

How Can MasterControl's CAPA Process & Procedure Help?

MasterControl CAPA management software 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.