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Corrective Action Preventive Action (CAPA) is an approach used to investigate and resolve quality issues along with identifying their causes. It was introduced as a result of Food and Drug Administration’s (FDA) requirement under FDA 21 CFR 820.100. The CAPA mainly consists of two functions:

  1. Corrective Action – The goal of Corrective Action is to identify the root cause of the product and quality problems and take appropriate action against them. This includes:
    1. Review and definition of a problem
    2. Identification of the root cause of a problem
    3. Development of action plan for correction and prevention
    4. Implementation of the plan
    5. Evaluation of the plan efficiency
  2. Preventive Action – The goal of Preventive Action is to prevent the problem from recurring in the near future. This includes:
    1. Identification of potential problems
    2. Identification of root cause of the problem
    3. Development of recurrence prevention plan
    4. Implementation of the plan
    5. Review of effectiveness of actions taken for prevention

CAPA and The Procedures

To implement an effective CAPA plan, the following steps must be followed:

  1. Identify potential problems related to quality, product or non-conformity
  2. Evaluate the seriousness of the problem and how it would impact the business
  3. Evaluate the available procedures for investigation
  4. Analyze the problem with accurate data
  5. Create an action plan that addresses all the problems and solutions to prevent them
  6. Implement the plan
  7. Perform regular follow-ups to ensure the effectiveness of the solutions

A CAPA plan is necessary to ensure problems and non-conformity are reported and prevented in stipulated time. To know more about how to streamline CAPA procedures and other robust quality solutions, reach out to Freyr at sales@freyrsolutions.com.