Questions regarding Non-Conformance, Corrective Action and Preventive Action

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bill1025

Hello all, I'm currently creating procedures for a company that I'm doing a master's placement in, and I'm new to quality, so I hope you experts can enlighten me. Here are my questions regarding non-conformance, correction, corrective action, preventive action.
Question 1:
I do know that in the case that a non-conforming product is identified, authorised personnel need to decide whether a corrective action is needed. However, in an internal audit, a date should be agreed between auditor and auditee when a follow up action will be taken to make sure the corrective action has been implemented. Does this mean a corrective action is required for each non-conformance identified during an audit?

Question2:
My understanding of correction, corrective action and preventive action is correction is a one-time thing which is taken to correct a nonconformance(some people call it containment?): corrective action is taken to prevent the same nonconformance from happening again; preventive action is taken to make sure that potential nonconformances from happening for the first time. Is this correct?

Question 3:
The company I'm working for uses a 8D corrective/preventive plan to address non-conformances, and I was looking at the knowledge of this 8D approach and it's quite confusing for me. STEP 6 implies that corrective action has already been implemented and the effectiveness has already been verified AND STEP 7 implies that further actions should be taken to to prevent recurrence. Isn't Step 7 a repeat of Step 6? Or Does this 8D plan incorporate corrective action and preventive action?

Hope you guys understand my questions and thanks in advance!
 

qusys

Trusted Information Resource
Re: Questions regarding non-conformance, corretive action and preventive action

For the first two questions, the response is yes.
For the third, your assumption on thepreventive actions is correct.
 
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bill1025

Re: Questions regarding non-conformance, corretive action and preventive action

For the first two questions, the response is yes.
For the third, your assumption on thepreventive actions is correct.
Thanks for your answer. However, I have a further question.
Now that preventive action is taken to prevent potential problems from hapening, but in 8D approach non-conformance has already taken place. Isn't this a bit contradictory?

Thanks again
 

qusys

Trusted Information Resource
Re: Questions regarding non-conformance, corretive action and preventive action

Thanks for your answer. However, I have a further question.
Now that preventive action is taken to prevent potential problems from hapening, but in 8D approach non-conformance has already taken place. Isn't this a bit contradictory?

Thanks again

Preventive action could be seen as a possible extension of the corrective action to similar process/systems/products if applicable.
There are many interpretations for this and different school of thought.
The advice is to act as much as reasonable possible:bigwave:
 
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Boscoeee

Re: Questions regarding non-conformance, corretive action and preventive action

Thanks for your answer. However, I have a further question.
Now that preventive action is taken to prevent potential problems from hapening, but in 8D approach non-conformance has already taken place. Isn't this a bit contradictory?

Thanks again

I think the answer to your question is in the definitions of Corrective and Preventive Action.

From EN ISO 9000-2005 Quality Management Systems - Fundamentals and Vocabulary

Corrective Action - Action to eliminate the cause of a detected nonconformity or other undesirable situation.

Preventive Action - Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.
 

Roberticus

ASQ CQE
Re: Questions regarding Non-Conformance, Corretive Action and Preventive Action

Question 3:
The company I'm working for uses a 8D corrective/preventive plan to address non-conformances, and I was looking at the knowledge of this 8D approach and it's quite confusing for me. STEP 6 implies that corrective action has already been implemented and the effectiveness has already been verified AND STEP 7 implies that further actions should be taken to to prevent recurrence. Isn't Step 7 a repeat of Step 6? Or Does this 8D plan incorporate corrective action and preventive action?


These "actions to prevent recurrence" you refer to, in the course of our 8D Corrective Actions, can include:
  • The application of the chosen CAs to similar product (similar features, characteristics, or processing operations) applications to the one where the original NC was discovered,
  • short-to-medium term monitoring (and documentation of monitoring) of the implemented corrected actions as a follow-up to gauge their effectiveness as sort of a "pre-closure" phase,
  • Summaries of updates or revisions to SOPs, work instructions or the like, which incorporate the implemented CAs as a permanent improvement to the QMS.
At least by our utilization, the "actions to prevent recurrence" section preceeds a final "Closure and Effectiveness" block where the NC owner(s), team leaders, and QA representatives signoff to approve closure. As a bridge between implementation and closure, Step 7 can be really effective in validating the implemented CAs and providing a narrative on how they were made a permanent part of the QMS.:2cents:
 
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bill1025

Re: Questions regarding Non-Conformance, Corretive Action and Preventive Action

Thanks for all your replies! I really appreciate them :thanx:
 
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JaneB

Re: Questions regarding Non-Conformance, Corretive Action and Preventive Action

Question 1:
Does this mean a corrective action is required for each non-conformance identified during an audit?
No, not necessarily. If there are several NCs which all appear to have a common cause, much, much better to write a single NC that covers all of them. eg, suppose you found multiple NCs that all arose from failure to effectively control engineering drawings... then write ONE NC to address that failure, don't write lots of individual ones for each drawing failure.
 
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