Medical Device Manufacturing: CAPA Management and Best Practices

Implementing a CAPA system (Corrective and Preventive Action) is required by the FDA for Medical Device Manufacturing companies selling equipment in the U.S. Despite the alterations and expense required, manufacturers now appreciate how CAPA has increased product reliability.

When CAPA systems are well designed and implemented they can advance progress in three major areas:

  • Increasing regulation compliance
  • Improving effectiveness in prevention
  • Boosting efficiency in identifying and correcting problems; preventing occurrences

Management Strategies

Effective techniques for administering a CAPA system include:

Establishing an Operationalized SOP – Company SOP must be detailed and comprehensive. It should include CAPA regulations, definitions of preventive and corrective actions applicable to the company and how it will be decided when a problem should be escalated to a CAPA request. Corrective procedures should address devices already distributed as well as those which remain in-house.

Securing Resources – Specific database programs and other software will need to be purchased. Required employees with training and experience necessary to provide the variety of functions within a CAPA system must be hired and be designated as dedicated CAPA staff.

Analysis and Documentation – Data should be analyzed frequently and fully documented, with reports given to management who should disseminate them to staff. When CAPA problems are identified, a summary of corrective action taken should be shared with all company employees. Each example will educate staff on how such issues are handled and how to increase the probability of preventing reoccurrences. The information should also be used to rainstorm potential future problems not previously anticipated and to plan prevention projects to address anything identified.

Use Causal Analysis – When a problem occurs, brainstorm with the appropriate group to determine at least two causes that resulted in the problem, one condition and one action that individually would not have resulted in problems but when combined lead to the difficulty. Determine the best corrective action based on preventing combinations of these causes from reoccurring.

Evaluate all prevention and corrective procedures put into place to ensure they are effective. If not, ask those involved for their perspectives and analyze new data for indications of how to alter the plan to increase efficacy. Incorporate in the SOP all alterations in procedures necessary to correct and prevent identified nonconformity or other problems and make certain each employee is aware of the changes.

At Life Science Outsourcing Inc., our Quality Team follows these best practices through an established SOP of problem escalation, identification, analysis and preventative measures. We have guidelines in place for response times to the client and an incentivized quality control system to reduce the occurrence of errors. For LSO, applying the above mentioned guidelines has lead to improved problem solving abilities resulting in more preventive plans than corrective actions being implemented.


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