THE DIFFERENCE BETWEEN A CORRECTIVE ACTION VS PREVENTIVE ACTION IS OFTEN OVERLOOKED BY QUALITY MANAGERS AT MEDICAL DEVICE COMPANIES, ESPECIALLY BECAUSE THE TWO ARE SO FREQUENTLY LUMPED TOGETHER BY ISO AND THE FDA.

When you make an acronym out of something, the meanings of the individual words are sometimes overshadowed by the new word that you've created. That's exactly what happened when we turned Corrective and Preventive Action into CAPA - the system of policies and procedures that medical device companies use to address non-conformance issues within their manufacturing processes.

To make things even more complicated, 21 CFR Part 820.100, the part of the medical device quality system regulations that discusses corrective and preventive actions, does nothing to distinguish the two at all. To find a real distinction in the quality literature, you'll have to take a look at ISO 9001:

8.5.2 Corrective Actions: “The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence.

8.5.3 Preventive Actions: “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”

CORRECTIVE ACTION VS PREVENTIVE ACTION: WHAT'S THE DIFFERENCE?

The main difference between corrective actions and preventive actions lies in whether the nonconformity has taken place. If a nonconformity occurs, it's up to the quality manager to identify and evaluate it to determine whether a corrective action needs to be implemented. If so, a CAPA incident is triggered and the quality manager should fill out a CAPA form and follow the process. A root cause analysis should be undertaken to determine why the nonconformity happened, and an action plan should be developed to prevent recurrence.

Preventive actions are used to prevent nonconformities that might occur in the future but have not happened yet. They are the result of organizations using the information at their disposal to effectively identify potential sources of error before they lead to nonconformance issues.

Organizations may perform many types of preventive actions without explicitly noting or even realizing that they are doing so. For example, holding a staff training workshop is a preventive action that is targeted towards reducing errors related to the type of training that is administered. Internal audits are also a preventive action because they can detect issues with equipment, fail-safes, or processes that might lead to a nonconformity issue if left unaddressed.

WHAT PREVENTIVE ACTIONS SHOULD YOU TAKE?

Preventive actions and preventive healthcare procedures are very similar - they both cost money, neither is fun, and they both provide tremendous long-term value for those with the wisdom to pay the short-term cost of long-term stability. Here are some examples of preventive actions that can help avoid nonconformity issues:

  • Auditing suppliers and the materials that they provide you with
  • Routinely inspecting and servicing equipment to ensure it is properly calibrated
  • Installing alarms into processes, in the form of process control charts or monitoring statistics
  • Collecting process feedback from line workers
  • Comprehensive training programs with employee reviews

GREENLIGHT GURU HELPS MAINTAIN YOUR CAPA SYSTEM

Corrective and preventive actions together form the CAPA system, one of the core processes of quality management for every medical device company. When nonconformance issues are discovered, there are extensive documentation requirements for nonconformance management that can be facilitated by Greenlight Guru's cloud-based eQMS system.

When a nonconformance is escalated to a CAPA investigation, a CAPA form is created and logged into the CAPA portion of the QMS system where it begins the CAPA process. The same process is used to initiate and track preventive actions that are meant to proactively prevent nonconformance issues from occurring.

Greenlight Guru's Quality Management Software is a secure and accessible repository for all legally-mandated quality management documentation that your medical device company is responsible for. Keep your records organized can help you save time, reduce costs, and breeze through your next FDA audit, helping you get to market even faster.

Are you interested in learning more about our Quality Management Software? Let’s take Greenlight Guru on a demo.

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