Performing a Risk Evaluation
Corrective Actions (CA) are another critical aspect of a quality management system. These are improvements made to a process or product in order to eliminate the cause(s) of non-conformances. The concept of CAPA (corrective and preventive actions) is discussed in 21 CFR 820.100, ISO 9001 (clause 8.5.2) and GMP.
Corrective Actions can be initiated in reaction to customer complaints/feedback, product non-conformances, audit findings (internal, external or regulatory), process monitoring via statistical process control (SPC), among various other inputs. Any type of non-conformance can be resolved through the CA program. Corrective Actions are especially applicable for systemic issues, or those that affect the quality of your products.
ISO 9001 has a requirement for companies to have a documented procedure to address Corrective Actions, as well as to maintain records of these actions along with their results. The CA procedure should contain the following requirements:
- Review and document the issue
- Contained and/or segregated effected items for investigation
- Perform an investigation
- Propose a solution to prevent the situation from being repeated
- Report on which actions were actually taken
- After implementation, perform an effectiveness verification
- Identify when it is appropriate to close the CA
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