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Iso 9001 corrective action & how to address nonconformances?



What is nonconformance? Nonconformance is when something does not meet the expected criteria or requirements when being audited. To repair this, corrective action should be taken. This can be defined as a systematic process for addressing these nonconformities and implementing the proper steps to correct the complication.

 

Below nqa.com discusses the 5 steps that should always be taken to correct these nonconformances:

There are many different versions of non-conformance plans and corrective action forms and some may require more information to be documented over others, however, when completing you should always follow the same principles when taking corrective actions:


  • Containment

  • Correction/Immediate Corrective Action

  • Root Cause

  • Corrective Action/Long Term Corrective Action

  • Verification of Effectiveness

 


Containment


Containment is taking immediate action to understand and control nonconformity to mitigate any potential harm or negative consequences.


Correction/Immediate Corrective Action


Correction starts by finding the cause of the problem and identifying the reason it was a nonconformance. After determining the issue, it is crucial to plan out the next steps that need to be taken for the issue to be corrected.  The severity of the nonconformance is important to recognize when going through this process as there may be more than one part to correct. Lastly, it is vital to implement immediate corrective measures to address the nonconformance.

 

Root Cause


The Root Cause is the most critical step in the process. You must dissect each part of the process to figure out the reason it happened and how it can be prevented from occurring again in the future.


Corrective Action/Long Term Corrective Action


Long Term Corrective Action implements a direct fix and long-term solution to the nonconformance. While it is important to correct the immediate issue, it is just as crucial to construct a plan that will prevent the nonconformance from reoccurring.


Verification of Effectiveness


Verification of Effectiveness is an important step because it allows for the use of facts to show proof of the process being successful in the long term. This verification includes creating records and documentation that the nonconformity is no longer an issue and measuring the effectiveness of the process that has been put into place to address the issue.

 


Overall, getting a nonconformance is not the end of the world. It gives you the opportunity to make your process more effective. Going back through your process in detail to identify the causes, and creating a plan to correct them will only improve your business. After implementation of your plan, it is essential to show its effectiveness on a recurring basis with supporting documentation. After all of these steps are complete, you will be able to close the nonconformance.

 

 

References

 

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