Corrective and preventive action

Corrective action and preventive action (CAPA, also called corrective action / preventive action) are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations^[1]. CAPA is a concept within good manufacturing practice (GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

Corrective actions are implemented in response to customer complaints, undesired levels of internal nonconformity, nonconformities identified during an internal audit or adverse or unstable trends in product and process monitoring such as would be identified by SPC. Preventive actions are implemented in response to the identification of potential sources of non-conformity.

To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal. CAPA is part of the overall quality management system (QMS).

Concepts

• Clearly identified sources of data which identify problems that will be investigated.
• Root cause analysis to identify the cause of a discrepancy or deviation and suggest corrective actions to potentially prevent recurrence of a similar problem, or preventive action to ensure that discrepancies do not occur.
• Remedial corrections of a problem which is identified.

A common misconception is that the purpose of preventive action is to avert the occurrence of a similar potential problem. This process is all part of corrective action, because it is a process of determining such similarities that should take place in the event of a discrepancy.

Preventive action is any proactive methodology used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk aversion). Corrective and preventive actions both include investigation, action, review, and further action if so required. It can be seen that both fit into the PDCA (plan-do-check-act) philosophy as determined by the Deming-Shewhart cycle.

Investigations to root cause may conclude that no corrective or preventive actions are required, and additionally may suggest simple corrections to a problem with no identified systemic root cause. When multiple investigations end in no corrective action, a new problem statement with expanded scope may be generated, and a more thorough investigation to root cause performed.

Implementation of Corrective & preventive actions is the path towards improvement & effectiveness of Quality Management system. Corrective actions is nothing but the action/s based on the problem identification. The problem or a non-conformance can be identified internally through staff suggestions, management reviews, document reviews or internal audits. Customer complaints / suggestions, customer rejections, non-conformities raised in customer / third party audits & recommendations by the auditors are the external sources which lead to find the ROOT CAUSE of the problem.

Corrective action is a reaction to any of the cause/non-conformance mentioned above & can be divided in two phases of action: 1) Identification of root cause: for this purpose TQM tools such as fish-bone or cause & effects analysis can be practiced. Your CAPA would be appropriate & effective if & only if you have identified the root cause of problem. 2) Taking necessary actions: in order to address the root cause take necessary immediate action/s. The effectiveness of the corrective action taken has to be verified periodically through a systematic approach of PDCA (Plan - Do - Check - Act) cycle.

Preventive action is prediction of problem & trying to avoid the occurrence (fail safe) through self initiated action/s & analysis related with your processes / products. This can be initiated with the help of active participation of staff members / workers through improvement teams, improvement meetings, management review, customer feedback & deciding own goals quantized in terms of business growth, reducing rejections, utilizing the equipments effectively etc.

Examples of corrective actions

• Error Proofing (Poka yoke)
• Visible or Audible Alarms
• Process Redesign
• Product Redesign
• Training or enhancement/ modification of existing training programmes
• Improvements to maintenance schedules
• Improvements to material handling or storage

In some cases a combination of such actions may be necessary to fully correct the problem.

References

1. ^ ISO 9000 Quality management system - Fundamentals and vocabulary. ISO. 2005. 

External links

• Good Manufacturing Practices for Pharmaceutical Ingredients (ICH)
• Quality Systems Approach to Pharmaceutical CGMP Regulations (FDA)
• Current Pharmaceutical links (FDA)
• Good Automated Manufacturing Practice (GAMP)
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• Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes