CAPA Quality System – More than Just Corrective Action

A CAPA Quality System (CAPA is an acronym for ‘Corrective and Preventive Action’, or ‘Corrective Action, Preventive Action’) is absolutely essential in some format for a complete quality management program.  In fact, in at least one quality management system, Good Manufacturing Practices (GMP), it is a requirement and a fundamental tenet of the program.  GMP is the quality management system that must be used by pharmaceutical and medical equipment manufacturers to comply with FDA guidelines.

What it is called in a particular system is not nearly as important as the fact that it absolutely must exist within the quality program.  The corrective action, preventive action program is the means by which unforeseen issues are addressed, remedied, and eliminated from ever happening again.  A CAPA quality system is a required part of ISO compliance, and is a vital part of TQM practices if a company ever expects to reach its goal of zero defects. 

CAPA programs are not difficult to understand or implement, nor are they difficult to execute.  Where many companies fall short is in the follow-up portion, or ‘closing the loop’.  In a typical program, a defect, malfunction, shortcoming, or other unexpected occurrence will be identified, triggering a root cause analysis (or similar program) to identify the underlying cause of the defect.  This will usually be the responsibility of a cross-functional team. 

The corrective action portion of the program is pretty straightforward – it’s what you do to fix the malfunction or defect that has been found.  This can be everything from shutting down and inspecting machinery, issuing a public recall, retraining all of the production workers, modifying a computer program, modifying an operating procedure, or whatever else may be necessary to stop the defect and make the system right.

What often lacks in a capa program is the “PA,” or Preventive Action completion.  When the root cause analysis team meets to discuss short-term solutions to the problem, they are also charged with developing and implementing a series of permanent fixes to ensure this same problem can never again happen at this facility (or company if there are multiple manufacturing sites). 

Preventive Actions can be anything, but some typical ones are:  Write a new procedure and train everyone on it, documenting the training; Replace carbon steel stamp with stainless steel stamp to prevent oxide contamination; Inspect every other machine that performs a similar function at the facility to ensure it does not have a similar issue;  Perform periodic maintenance inspections; Rewrite the operating system program so no operator can enter this number if that number is showing…  and so on.  Some of the best ideas in an organization come from failure analysis meetings. 

The problem is that many times no one ever follows up to ensure the preventive actions are carried out, and verified as a true “fix.”  Names and dates will get assigned to individuals to perform one step or another, but very often there is no method to go back and see if the actions were completed, and if they were completed whether or not they actually fixed anything.  This is why a “true CAPA” quality system is such an important part of every Quality Management Program. 

In a true capa system, there is a formalized process to “close the loop” to make sure all of the corrective and preventive actions were completed, that they perform as they were intended to perform, and the organization can be assured that it will never have to deal with this same issue again.  This program is an easy program to automate, and there are many software and IT firms that have introduced closed-loop CAPA software programs.  It starts with the actions, expected completion dates, and champions being entered into a system-wide database. 

This database can automatically issue ticklers, send out weekly updates to everyone with open corrective or preventive actions, and flag superiors when completion dates have passed.  Most importantly it will notify a team of folks when all of the actions have been completed.  When this happens, a group must reconvene, review each of the actions to ensure that it met its purpose, and also that no new issues have arisen as a result of implementing these actions before closing out the root cause analysis.

This is an audit item for ISO, GMP, and several other TQM programs.  Inspectors audit for compliance, incomplete actions, incomplete failure analyses, and items that have been flagged as complete to verify the claim.  But the truth is that even if this weren’t an audited item, it logically would be included in every quality program anyway. 

The capa system is one of the best ways to find, fix, and eliminate defects from the process.  Fixing it once and ignoring the root cause guarantees that the issue will return.  And every time it comes back, it will be as costly as it was the first time to fix.

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