CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry. The program to make effective corrections and ensure that preventative applications were incorporated was in use way back in the 60s by NASA and the FAA to enhance safety but was not labeled CAPA even though the intent was the same.
These are a few must know facts about CAPA:
1. Causes of 483s, Warning Letters and Consent Decrees
A huge majority of the existing industry shortages which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation and effective means of assessing various elements of CAPA expectations for products produced and distributed under the FDA regulations.
2. Purpose of CAPA
The idea of the corrective action and preventive action (CAPA) subsystem of the overall quality system is to gather all information, analyze information and investigate product quality issues, and take suitable and successful corrective/ preventive ways to put off recurrence of the incident which may have patient impact when used by consumers of the company’s products. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review and documenting these activities are essential in dealing effectively with the product and quality problems, preventing their recurrence, and preventing or minimizing device failures which is intended to generate continuous quality improvement.
3. Corporate Policies
The corporate policy is to provide CAPA definitions and interpretation of words or terms such as "nonconforming product", "quality audit", "correction", "prevention", "timely", “cGMP related incident” and other cGXP compliance related activities that may require correction or prevention related to products produced by the company to be used by FDA regulated customers. The CAPA procedures issued in accordance with this corporate policy are to include instructions to ensure the company will meet the quality system requirements for the CAPA subsystem. CAPA procedures (SOPs) are generated and implemented to ensure acceptable release of the final product.
4. Steps in a CAPA Decision Process
Prior to issuing a CAPA tracking number, the observation, trend or incident must be initially evaluated by a team of individuals from the associated departments such as operations, technical services and quality to determine if the incident, observation or change requires immediate correction, simply change control or if a CAPA is needed to prevent recurrence or occurrence. The potential impact of the incident, observation, change or trend and the risks to the patient must be evaluated or calculated to conclude if correction, corrective action or preventative action is required.
5. CAPA Request, Initiation and Description
Once evaluated to determine the need for action based on quality review, a CAPA is to be requested and initiated and approved by operations, technical services and quality. The initiation process typically establishes the level (severity) of the issue and the urgency of the required action. The potential impact of the issue and the patient risk are to be determined and documented. In the event that the initiation process determined that a CAPA is not needed a technically concise rationale must be provided.