FDA QSR Corrective and Preventative Action Requirements.

The FDA Quality System Regulations (QSR’s) as detailed in part 820 of the CFR’s, require that an effective corrective and preventative action process (CAPA) is established. The FDA understand that even in the most diligent and compliant of manufacturing establishments, errors, failures and non-conformances will arise in processes and products. Therefore, the FDA see it as critical to ensuring product quality, if and when failures arise, that appropriate action is taken by the manufacturer to address the failure, to prevent or minimize potential for patient injury, to understand the failure and to implement corrective and preventative actions to address the failure and to prevent any repeat.

In order to require manufacturers to implement affective systems to achieve the above the FDA specifically require that corrective and preventative action (CAPA) procedures be defined, documented, released and fully implemented.

The CAPA procedures will require all errors, failures or non-conformances which have impacted or could impact product quality to be investigated. Failure investigations should include if necessary the application of appropriate statistical techniques. The output of the investigations, should be identified root causes and recommendations to permanently address.

The identified actions need to be assessed to ensure they will not impact the quality of the product, e.g. process re-validations may be required before any changes are implemented. The identified corrective actions will need to permanently address the original failures and the manufacturer needs to confirm or verify that the failure has truly been addressed.

Where change to the process or product is implemented as a result of the CAPA process, then all such changes will need to go through a defined change management and change control process.

At every stage in the CAPA process, all necessary information needs to be documented and these documents will become key quality system records.

These CAPA quality records, will need to be made freely available to relevant personnel and will need to be reviewed as part of the on-going Management System Reviews.

PART 820. QUALITY SYSTEM REGULATION

Subpart J – Corrective and Preventive Action

Sec. 820.100 Corrective and preventive action.

(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.

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

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>