The purpose of a CAPA program — that is Corrective Action and Preventive Action — is, as the name implies, to correct process or product non-conformances and to take steps to prevent or eliminate them in the future. CAPA can be triggered in a number of ways: management reviews or audits of a management system, quality system or performance metrics. CAPA can sound simple and necessary, but its successful implementation is a challenge that most pharmaceutical manufacturers grapple with.

Putting a CAPA program in place requires adhering to some basic principles. First, CAPA programs should make sense. They should be easily implemented and managed. Many CAPA programs are after the fact, addressing problems after they occur and documenting them on a CAPA action form. But a CAPA program must go beyond this. It must be proactive and able to correct problems at all levels of the organization, be easy to use and track progress of the action and be able to show results that it is working. That is, a CAPA program must be systematic and measurable.

ISO 9001:2000 provides a description of Corrective Action and Preventive Action Requirements and may be helpful to establish your CAPA program. But ultimately, whose responsibility is CAPA? Usually the Quality Assurance manager is responsible for the CAPA program and for defining, developing, implementing and maintaining documented procedures for the program. The most qualified person to investigate problems is typically someone else — often a Quality Control engineer or process engineer. The person who implements the corrective action should be the manager who is responsible for the affected work area or process.

It’s often thought that FDA’s 21 CFR Part 11 contains a clause for CAPA.

Not so: Clear guidance can be found in 21 CFR 820, Subpart J – Corrective and Preventive Action Requirements

[b][COLOR=“blue”]Para 820.100

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records complaints, returned product and other sources of quality data to identify existing and potential causes of nonconforming product, ort other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems.

(2) Investigating the cause of nonconformities relating to product, processes and the quality system.

(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems.

(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.

(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.

(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product for the prevention of such problems.

(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.[/color][/b]