PMS and the role of CAPA in the medical device regulatory cycle

Medical devices and their evolving technologies have increasingly important roles in the diagnosis and treatment of patients. Mirroring this expansion in the use and availability of medical devices is the growing focus on global regulation and certification. An integral aspect of these regulatory processes is to have a robust quality system across all manufacturing phases and continuing the effective monitoring cycle in post marketing phases. In addition, medical device regulatory experts are working together to harmonize regulatory models and quality standards globally. Organizations such as the Global Harmonization Working Party (GHWP; also known as the Asian HWP)2 and International Medical Devices Regulatory Forum (IMDRF)3 are examples of global efforts to harmonize and align regulation of medical devices. The two organizations are also developing strategies for supporting innovation and strengthening post marketing surveillance to ensure safe use of medical devices.

Monitoring of medical devices and quality checks are key players in the regulatory cycle. Manufacturers are required to apply the quality management system in all manufacturing phases and perform quality checks through the manufacturing lines and continue monitoring quality and safety issues during the post market phase.

CAPA is a structured approach for establishing root cause and is developed within the context of good manufacturing practices, hazard analyses, and International Organization for Standardization parameters. It is considered a subsystem of the quality management system. The establishment and implementation of a CAPA system is required by regulations for all medical device manufacturers. CAPA is a pivotal element of the overall quality management system. The CAPA process entails the systematic investigation of discrepancies, deviations, and/or failures that occur in the product, processes, equipment, or associated areas.

A functional CAPA subsystem comprises:

  • Collection and analysis of information to identify actual and potential product and quality problems.
  • Corrective action – identification and elimination of the existing causes of the “nonconforming” product and other quality problems.
  • Preventive action – identification and elimination of the potential nonconforming product and other quality problems.
  • Verification or validation of effectiveness of corrective and preventive actions.

When establishing a CAPA system, a manufacturer should ensure its CAPAs are effective in correcting/ preventing discrepancies and that they do not have an adverse effect on other aspects of the product, process, equipment, or system. This can be done by having a verification process that is specific to the issue but that also monitors the corrected error over time by sampling and testing product against company specifications, testing product-contact equipment, and following up on or spot checking the training of employees involved with the CAPA.