Exploring Techniques in Corrective and Preventive Action Part 2

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Welcome back, We wrapped up our last conversation discussing corrective and preventive actions as they relate to the requirements of ISO 9001 so we will start where we left off looking at requirements.

Corrective actions in ISO 9001 can be found in clause 8.5.2, requirements (A) through (F) beginning with the general requirement “The organization shall take action to eliminate the causes of nonconformities to prevent their recurrence…” All of these requirements should be addressed in a documented procedure controlled in your business management or QMS system. Incidentally, having this documented procedure is also a requirement of ISO 9001 (8.5.2) Managing a conforming corrective and preventive action process is not easy but there are many CAPA software systems that can help. The standard states that the cause(s) of nonconformity will be determined, the actions needed will be implemented, those actions reviewed for effectiveness and all records of this nonconformity and the associated actions will be maintained. Therefor it makes sense that the software solution must provide tools that assist the user with cause determination, corrective action tracking with workflows to notify and remind personnel responsible for the corrective action process and some mechanism to ensure that actions implemented are reviewed for effectiveness before problem reports are closed. By design, CAPA software systems should automatically generate and maintain records as required by ISO 9001.

Having these tools and not using them is a completely different issue. When organizations choose to simply fix the immediate symptoms of a problem as a posed to conducting a full root cause analysis and then eliminating the causes of nonconformity they set themselves up for repeat issues and nonconforming audit findings. It is still important to address the immediate symptom but this is considered by many industries as counter measure activities and not corrective action. For example, if someone is badly injured in car accident, the first thing to do is stop the bleeding, and tend to the injuries. Figuring out why the car crashed in the first place will come later. If we ignore the why, then this issue (car crash) could happen again.

Depending on the industry or the nature of your customers, this type of counter measure followed by corrective actions may still not do enough to satisfy customer requirements. Where the customer complains due to product nonconformity, they may request two separate corrective actions for the same reported problem, one to prevent the production of further nonconformance and a second action for what in the quality process failed and allowed the nonconformance to escape? Good CAPA software systems must provide the tools for this type of advanced root cause analysis to support conforming corrective and preventive action processes and customer satisfaction.

Author's Profile

Akshat Kumar is the author of this article on Corrective and Preventive Actions and CAPA Software. He is a veteran quality professional and a contributing member of ISOQuest Product Realization Team. He is primarily responsible for the global deployments of the ISOQuest Suite of Products.


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