Guide on Corrective Action in accordance to ISO 9001:2015

Guide on Corrective Action in accordance to ISO 9001:2015

Guide on Corrective Action in accordance to ISO 9001:2015

One of the critical requirements that make of ISO 9001 is corrective action. In this article, we’ll guide you on what it entails, why it is essential and how to best go about it. Let’s delve right into it. 

What is Corrective Action?

Corrective Action (CA) is the activity taken to eliminate the cause of process nonconformity and to prevent its occurrence. It entails:

  • Reacting to a process nonconformity
  • Using containment action to get the nonconformity under control
  • Taking action to prevent a recurrence.

Why was Preventive Action (PA) abolished in ISO 9001:2015?

Before the latest revision of the ISO 9001:2015, there was a requirement for preventive action or PA, but it was abolished. This is primarily because organizations found it time-consuming to use PA; they felt that the time spent on Preventive Action could be better spent on risk analysis and mitigation.

With this revision, requirements have structured a way that there would be no need for Preventive Action if an organization followed them correctly. The following parts of the standard replaced Preventive Action.

  • Risk-based thinking-Risk based-thinking dictates that your organization identifies areas that could affect its QMS where the outcomes are uncertain. When you identify risk and determine the action you need to take in order to mitigate adverse effects, you are practising preventative action. This is covered under Clause 6.1 of ISO 9001:2015
  • Improvement– A suggestion that seeks to improve a QMS and its processes could prevent a problem from occurring in the system.

How to do Corrective Action

To implement a proper corrective action, there has to be a sequence of how actions are taken. Here is an ideal one

  • Define in clear terms what the problem is.
  • Identify the scope of the problem. This is also called Extent Analysis.
  • Identify the root of the problem
  • Figure out how to stop the problem while addressing the root cause.
  • Detail a plan that fixes the root problem-Be careful here, that your solution doesn’t cause more problems
  • Put your plan in place.
  • Check that your plan is working.

A corrective action plan and what it includes

An excellent corrective action plan remedies the root cause of a problem and not just the symptoms. Consider the following when creating one.

  • Root cause assessment– ask yourself whether you have correctly identified the root cause or whether you are dealing with manifestations of the root cause.
  • Detail steps– What steps are needed to eliminate the root cause of the problem?
  • Asses schedule and cost– Have an exact time-line of implementation. You will also need to know how much it will cost you.
  • Create a system for assessment/audit– You will need to assess how your plan is working along the way. Do you need to make any changes?
  • Assess effectiveness-How long will you have to wait to know the plan has worked? Which Key performance indicator will be affected first as a sign that the plan is effective?

It is essential to set expectations on how long the project will take and the resources that will be involved. Ensure that your organization is realistic with the goals it creates and loops in all parties that would like to see its successful implementation. It is a team effort.

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