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CAPA processes

CAPA processes: The 10 key features that help identify the root cause of your non-compliance.

At Konsolute we’ve designed checklists, tasks and action processes to support your CAPA requirements in our QMS for M365

The Corrective and Preventive Action (CAPA) process is a fundamental component of good practice that affects all of the control points in an organisation’s quality management. From experience and working with third party auditors, we know that CAPA processes are rigorously tested during investigations.

For companies implementing strict certification and complex auditing, failure isn’t that common. However, when standards do fall short, it’s vital to know why and how best it can be stopped from happening again. Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure businesses that issues will never repeat.

Reassurance for your entire ecosystem

CAPA can and should be utilised in hundreds of business processes. Having said this, we mainly see CAPA taking place in manufacturing, testing verification and validation, distribution, shipping, transport and packaging and use-applications.

So, what is Corrective Action Preventive Action (CAPA)?

CAPA can be easily split into two distinctive categories: Corrective Action (CA) is a follow on from an initial task known as Root Cause Analysis (RCA). The first goal of CA is to find the root cause, base event or error that preceded the problem. From this point, action should be directed at the root cause or error. Preventive Action (PA) is similar to ‘Lessons Learned’. The primary goal of PA is to inform an organization and prevent the problem from returning in other processes, products or departments.

Why should your organisation be harnessing good Corrective Action Preventive Action processes?

Identifying the root cause of failure is fundamental to a successful QMS system. A hiccup in production or product is often the sign of something larger at play. Issues can be treated as a short term fix but the main purpose of CAPA is to address the root cause. In FDA regulated organisations, failure to integrate a Corrective and Preventive Action process is a violation of regulations that are outlined in their good manufacturing practice documentation

The 10 key features of any successful CAPA cycle:

  1. Defined and documented CAPA procedures.
  2. Evidence that product and quality problems have been identified and dealt with.
  3. Tracking of trends relating to risk and non-conformance.
  4. Organisations are using appropriate data sources for Corrective and Preventive Action
  5. Verify that appropriate methods are used to detect recurring quality problems.
  6. Confirm that the actions implemented are relevant to the level of risk identified.
  7. Actions directly address the root cause and offer long term solutions.
  8. CAPA process tasks are verified and proven before being carried out.
  9. All tasks relating to CAPA processes are documented
  10. Issues and all corrective action should be shared appropriately with staff/management in a CAPA review.

Our Quality Management System is designed help empower your CAPA processes through the adherence to the standards, action plans and tasks that you mandate. If you’d like to know more, why not book in for a call with our team of experts?

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