Corrective and Preventive Action (CAPA)

What is Corrective and Preventive Action (CAPA)?

The goal of CAPA is to correct and analyze information, identify and investigate product and quality problems, and take appropriate preventive and/or corrective actions to prevent the reoccurrence of these problems.

Some elements that are completed under CAPA include:

  • Communicating CAPA activities to responsible people
  • Verifying or validating CAPAs
  • Providing relevant information for management review
  • Documenting all CAPA activities
  • Determining if appropriate sources of product and quality problems have been identified
  • Ensuring that failure investigation procedures are followed

Pharmaceutical and medical device industries must document CAPA processes for the Food and Drug Administration (FDA) and follow the processes defined if a problem occurs.

Why is CAPA important for healthcare?

CAPA is a crucial element of quality assurance that requires manufacturers to follow up on any reports of product and quality problems and take the necessary preventive and/or corrective actions to minimize their likelihood of reoccurring.

A CAPA plan offers a structure to find the root cause of the problem, solve the problem, and then document the solutions for the future. Taking these steps and having a CAPA plan in place offers safe and effective products to consumers.