ISO 9001 Corrective Action Vs Preventive Action

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Corrective action and preventative action (often referred to as CAPA) work to improve the processes of organisations through a set of measures which aim to eliminate the causes of recurring non-conformances and other unwanted situations.

Some companies struggle with implementing effective systems for corrective actions or are of the opinion that it is a waste of time, but if used correctly in line with ISO 9001, they can be very beneficial, especially when applied to companies in industries such as pharmaceuticals, biologics, food & beverages, chemical, biotechnology and others.

What Are Corrective and Preventative Actions?

Any company that uses a quality management system or QMS understands that in order to achieve continuous improvement and high levels of customer satisfaction that corrective and preventative actions are essential.

This is particularly important if the QMS used is based on ISO 9001 which states that;

Corrective Actions – “The organisation shall take action to eliminate the causes of nonconformities in order to prevent a recurrence.”

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

What this means is that whilst corrective actions prevent ‘recurrences’, preventative actions prevent ‘occurrences’. The corrective actions are reactive and are carried out after a non-conformity has already transpired whereas preventative actions are planned and implemented to deal with potential issues before they happen to prevent non-conformities from occurring.

Why was Preventive Action Removed from ISO 9001:2015?

ISO 9001’s previous version included requirements for both corrective action and preventive action processes as part of quality management, the steps for which were essentially the same. However, the actions that generated the process was different with corrective actions reacting to a problem that occurred and preventive action being initiated by the identification of a potential problem.

In the latest revision of ISO 9001:2015, mentions of preventive action or PA have been removed, not because this type of preventive measures aren’t vital but more so that the way they are viewed, applied and undertaken needed to be revised. The new structure sees a more ‘risk-based’ approach in a way that means there is no need for time consuming preventive action but rather more effective risk analysis and mitigation.

The underlying philosophy for this change is that with ISO 9001, the QMS itself provides the preventive actions and that when risks and opportunities are revisited or adjustments are made to continually improve the QMS, this is in itself preventive action.

In the updated version of ISO 9001, preventive action has been replaced by other parts of the standard such as:

Risk-based thinking – This requires that you identify areas that could potentially affect the QMS but where you are uncertain of the outcome. This risk based thinking requires being able to identify this uncertainty, or risk, and determine if action needs to be taken in order to prevent a bad outcome or to make the most of possible beneficial outcomes, essentially risks and opportunities or ‘positive risks’.

Improvement – Improvement activities which make the QMS processes better are preventive actions. The new requirements focus is that each company find ways to improve their processes, rather than the previous versions of the ISO 9001’s complicated preventive action system.

Implementing Corrective And Preventive Action

Here is an example of what steps can be taken in the approach to corrective and preventative action;

  1. Identify the problem with the process – Clearly and thoroughly define the problem.
  2. Ascertain the size of the problem – To what extent, how far reaching, what will be affected by the problem?
  3. Take necessary action to contain the problem – How can you stop the problem from worsening whilst you work on fixing the root cause?
  4. Pinpoint the root cause of the issue – What is at the centre of the problem below the surface manifestation?
  5. Create a plan to resolve the root cause – What needs to be done to eliminate, fix or remove the root cause? Ensure that the plan will not cause further complications.
  6. Put the plan in place – Carry out the necessary actions of your plan.

Carry out necessary checks, tests and reviews to see if it worked – Make sure that the plan was effective.

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