21 CFR 820 - 820.100 CAPA

Original text

Expert opinion

(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, or 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 or the prevention of such problems; and

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

CAPA procedures must be implemented and maintained in written.

The process defines the requirements for the defined list of tasks. Each of these quality related aspects have to be monitored and evaluated statistically, preferrably by statistical tools and in conformance with 820.250.

The CAPA procedure has a basic work flow in which a nonconformance or deviation might trigger it. The basis work flow is beginning at the statistical evaluation and monitoring recognizing an issue. Then, an investigation is started to elucidate the root cause, often referred to as root cause analysis (RCA). Derived from the RCA, actions to correct the error and actions to prevent the error from future occurence can be identified. The corrective action is then tested for efficacy by means of either verification or validation. This usually triggers an update in the corresponding documentation and procedures as well as leads to information or training of the staff.

CAPA’s are an important part of management responsibility and thus, need to be communicated and provided for review.

(b) All activities required under this section, and their results, shall be documented.

CAPA’s are important to review the safe and effective use of a medical device. Thus, all activities and results must be documented for future review.

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