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Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes.

The ultimate purpose of CAPA is to assure the problem can never be experienced again. CAPA can be applied in many fields, such as:

  • Manufacturing
  • Product Design
  • Testing Verification and Validation
  • Distribution, Shipping, Transport and Packaging
  • Use-Applications

The two aspects of CAPA have traditionally been connected, but are only distantly related. Here is the main difference between the two:

  • Corrective Action: Elimination of the cause or causes of an existing nonconformity or undesirable situation in order to prevent recurrence.
  • Preventive Action: Identification and elimination of the cause(s) of potential nonconformities in order to prevent occurrence.

Furthermore, corrective action involves the identification, documentation, and elimination of the root cause of a nonconformity or problem to prevent the problem from recurring. Corrective actions are taken under more intense consideration than corrections (which address immediate issues), and are usually enacted over a slightly longer time period to prevent recurrence.

Most corrective action procedures use a variation of 8D (eight disciplines) problem-solving.

Preventative action prevents potential occurrences. Preventive action determines what in a project might veer away from the project management golden triangle of budget, schedule or quality. An example of this process would be checking the other garburator in another sink as well as U traps in two other sinks for existing problems and asking if any parts should be replaced now before they fail.

Fault tree analysis and Failure Modes and Effects Analysis (FMEA) are two commonly used to analyze risk or potential problems:

In certain markets and industries, CAPA may be required as part of the quality management system, such as the Medical Devices and Pharmaceutical industries in the United States. In this case, failure to adhere to proper CAPA handling is considered a violation of U.S. Federal regulations on good manufacturing practices. (To comply with the United States Food and Drug Administration’s code FDA 21 CFR 820.100, medical device companies need to establish a CAPA process within their QMS.)

Consequently, a medicine or medical device can be termed as adulterated or substandard if the company has failed to investigate, record and analyze the root-cause of a non-conformance, and failed to design and implement an effective CAPA.

Want to learn more about CAPA? Tonex offers CAPA Management Training, a 4-day course that covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field.

Additionally, Tonex offers nearly three dozen other courses in Root Cause Analysis Training. For more information, questions, comments, contact us.

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