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What is an FDA CAPA?

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The Short Version... Simply put, Corrective Action is based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Both are similar procedurally, but with the focus as described. Together, Corrective and Preventive Actions-typically referred to as CAPA (pronounced cap-uh)-are integral parts of a continuous improvement program.

Source: http://www.bizmanualz.com/information/2006/04/11/understanding-corrective-and-preventive-actions.html

The Long Version...
Corrective and Preventive Action (CAPA)
is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence. To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA is part of the overall quality management system (QMS). Concepts
  • Remedial corrections of a problem which is identified.
  • Root cause analysis combined with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem.
A common misconception is that 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 Plan Do Check Act philosophy as determined by the Deming - Shewhart cycle. Source: http://en.wikipedia.org/wiki/Corrective_and_Preventative_Action Understanding Corrective and Preventive Actions Corrective and Preventive Actions are key elements to a Quality Management System (QMS) that is focused on Continual Improvement and Customer Satisfaction. Indeed, any ISO 9000 type QMS should have this type of focus, unfortunately many do not. It is important to properly use these two sub-systems when building a new QMS based on any quality standard, or revising an existing QMS. In order to do this, one must understand the difference between Corrective and Preventive Action. Past Vs. Future Simply put, Corrective Action is based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Both are similar procedurally, but with the focus as described. Together, Corrective and Preventive Actions-typically referred to as CAPA (pronounced cap-uh)-are integral parts of a continuous improvement program. Both sub-systems require some type of a log to record each event; a Corrective Action Log and a Preventive Action Log. Each Corrective and Preventive Action will typically have a form that is used to record the details of the activity performed to satisfy the event; A Corrective Action Request (CAR, pronounced car, as in an automobile) and a Preventive Action Request (PAR, pronounced like the golf term, par). Sometimes the situation is only a problem because it is looked at in a certain way. Looked at in another way, the right course of action may be so obvious that the problem no longer exists. Corrective Actions Too often a company will fix a problem in their business process, say a customer complaint or product return, after the problem has occurred. This is typically product or event focused. Then the company will look at what they've done and say, "Well if we revise our shop router or procedure, this will not happen again." They will label this second phase as Preventive Action. While it is a future thinking type of activity, it is still Corrective Action because it is based on solving a problem that has already happened. A Corrective Action needs to focus on the Quality System, so in this example the systemic action taken is the revision of the shop router or procedure. This is Corrective Action. Preventive Actions Preventive Action activities must stand alone and not focus on past events. For example: Company XYZ has a Preventive Maintenance management program that requires manual data entry. It is working fine and there have not been any problems. However, it takes a lot of time to manage and does have a high potential for error or lost records. XYZ decides to purchase Preventive Maintenance software to manage this activity. Since the purchase is not based on problems that have happened and is focused on process control or making an improvement to the QMS, it is a Preventive Action. A functional Quality Management System should record and complete many more CAR's than PAR's. On an annual basis, a company may record only a few Preventive Action activities, while in the Corrective Action log many dozens of events are listed. For audit purposes, a handful of Preventive Action events will demonstrate that this important part of the QMS is functional. A primary source of Preventive Action activities is the Management Review process. Although the Management Representative, or Manager responsible for the CAPA system, can also initiate and record Preventive Action activities. Source: http://www.bizmanualz.com/information/2006/04/11/understanding-corrective-and-preventive-actions.html
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