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Compliance to 8.5.2 Corrective action 8.5.3 Preventive action

W

wywy2020

#1
According to
8.5.2 Corrective action is action to eliminate the causes of nonconformities in order to prevent recurrence.

8.5.3 Preventive action is action to eliminate the causes of potential nonconformities in order to prevent their occurrence.

My company is using 8D format for NCR raised.
8D format D7 only call for Preventive of recurrence.

Are my company compliance to 8.5.3 as Preventive of recurrence shall consider under 8.5.2.
By the way how your company implement 8.5.3, i found that many people confuse on CA of prevent recurrence and PA of prevent potential occurance. I saw myself company with CAPA form but PA was filled up with preventive of recurrance actions.
 
Elsmar Forum Sponsor
T

t.PoN

#2
Re: 8.5.2 Corrective action 8.5.3 Preventive action

just to make things clear:
D0 - Recognizing a problem
D1-Define team
D2-Define problem
D3-Containment actions
D4-Root cause analysis - do it for occurrence, escape and systemic causes
D5-CA plan - do it for occurence, escape and systemic causes
D6-Verification of actions implemented
D7-Preventing actions - Learning from the experience of CA implementation - how to deploy in other areas
D8-Congratulate team through recognition, demonstrating their work to larger audience and senior management, assigning them tougher challenges to crack...etc

Now to answer your question:
If you are using only D7 .
You are already applying part of the requirements of the Preventive Action, but i don't think this fulfill all the requirements.

For example: the preventive action procedure should be able to capture trends to prevent failure. not only learn from others.
Another example: risk assessment of potential problems is considered as a method to identify needed preventive actions.


Now if you are using 8D as a whole not just D7, then you'll be complying with ISO 9001.
D0 recognize problem/potential problem
 

Mikishots

Trusted Information Resource
#3
According to
8.5.2 Corrective action is action to eliminate the causes of nonconformities in order to prevent recurrence.

8.5.3 Preventive action is action to eliminate the causes of potential nonconformities in order to prevent their occurrence.

My company is using 8D format for NCR raised.
8D format D7 only call for Preventive of recurrence.

Are my company compliance to 8.5.3 as Preventive of recurrence shall consider under 8.5.2.
By the way how your company implement 8.5.3, i found that many people confuse on CA of prevent recurrence and PA of prevent potential occurance. I saw myself company with CAPA form but PA was filled up with preventive of recurrance actions.
As already mentioned, D7 is defined as Preventing Actions - Learning from the experience of CA implementation - how to deploy in other areas.

What this means is that just because you have addressed the occurrence of an issue in one area, it doesn't mean you are done. The idea is to examine other areas that can encounter the same issue, and prevent it from happening there as well.

An example:
The auditor has discovered that the training records in Cell #1 are not complete, and staff who have not been approved to perform critical operations in that cell are signing off on work orders. The manager stated that he didn't realize it was a requirement.

Your corrective action: Perform containment (at a minimum, conduct risk analysis on the items they signed off on), root cause (why did this happen), and corrective action (either get their records updated, or provide training).

The D7 Step: If this manager didn't know it was a requirement, ensure that other managers in other cells are aware that critical operations can only be performed by personnel that have been trained and have valid and current records of that training. If you don't do this step, and it's later discovered in another audit that Cell #2 also has the same issue, you have failed in addressing the non-conformance.
 
W

wywy2020

#4
my company D7 name it as "preventive of recurrence".
u mean i should change it as "preventive action" so that it cover bigger scope inlcuding potentiall nonconformities in order to prevent their occurrence?
 
W

wywy2020

#5
As already mentioned, D7 is defined as Preventing Actions - Learning from the experience of CA implementation - how to deploy in other areas.

What this means is that just because you have addressed the occurrence of an issue in one area, it doesn't mean you are done. The idea is to examine other areas that can encounter the same issue, and prevent it from happening there as well.

An example:
The auditor has discovered that the training records in Cell #1 are not complete, and staff who have not been approved to perform critical operations in that cell are signing off on work orders. The manager stated that he didn't realize it was a requirement.

Your corrective action: Perform containment (at a minimum, conduct risk analysis on the items they signed off on), root cause (why did this happen), and corrective action (either get their records updated, or provide training).

The D7 Step: If this manager didn't know it was a requirement, ensure that other managers in other cells are aware that critical operations can only be performed by personnel that have been trained and have valid and current records of that training. If you don't do this step, and it's later discovered in another audit that Cell #2 also has the same issue, you have failed in addressing the non-conformance.
my company D7 name it as "preventive of recurrence".
u mean i should change it as "preventive action" so that it cover bigger scope inlcuding potentiall nonconformities in order to prevent their occurrence?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
This subject is very much misunderstood.

let us consider that Corrective Action and Preventive Action each are self contained in separate elements; this is in addition to the preventive component of the Corrective Action element.

That means the preventive part of an 8D or any other Corrective Action, while required, does not satisfy the preventive action element. It satisfies the preventive portion of corrective action. The preventive action element is independent because we are expected to take actions on nonconformities before they happen, not just after they happen.

I hope this makes sense!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
I want to add that there is no reason why an 8D cannot be used for a preventive action. If a condition is recognized as not being satisfactory to reliably produce products and/or services with acceptable quality, that dissatisfaction's cause could be considered the nonconformity that an 8D is usually deployed to address. The 8D is nothing more than a disciplined project-based method to make a specific improvement.
 
T

t.PoN

#8
Totally agree with Jennifer.
Just change the D0 to:
D0: Recognize Problem or Potential Problem
then use the whole 8D as a procedure for corrective and preventive actions.
 

Big Jim

Super Moderator
#9
Re: 8.5.2 Corrective action 8.5.3 Preventive action

just to make things clear:
D0 - Recognizing a problem
D1-Define team
D2-Define problem
D3-Containment actions
D4-Root cause analysis - do it for occurrence, escape and systemic causes
D5-CA plan - do it for occurence, escape and systemic causes
D6-Verification of actions implemented
D7-Preventing actions - Learning from the experience of CA implementation - how to deploy in other areas
D8-Congratulate team through recognition, demonstrating their work to larger audience and senior management, assigning them tougher challenges to crack...etc

Now to answer your question:
If you are using only D7 .
You are already applying part of the requirements of the Preventive Action, but i don't think this fulfill all the requirements.

For example: the preventive action procedure should be able to capture trends to prevent failure. not only learn from others.
Another example: risk assessment of potential problems is considered as a method to identify needed preventive actions.


Now if you are using 8D as a whole not just D7, then you'll be complying with ISO 9001.
D0 recognize problem/potential problem
The confusion here is a common misunderstanding which is manifested here in the title used for D7.

The unfortunate thing is that the standard somewhat leads to this misunderstanding in that it uses the word "prevent" with corrective action. It may help to change your your title in D7 to "Prevent Recurrence". Preventing recurrence is part of corrective action, and is not part of preventive action.

As already mentioned, preventive action is action taken on potential nonconformances to prevent their occurrence.

Do something to make recurrence stand out as what you are preventing on corrective actions.
 
W

wywy2020

#10
Re: 8.5.2 Corrective action 8.5.3 Preventive action

The confusion here is a common misunderstanding which is manifested here in the title used for D7.

The unfortunate thing is that the standard somewhat leads to this misunderstanding in that it uses the word "prevent" with corrective action. It may help to change your your title in D7 to "Prevent Recurrence". Preventing recurrence is part of corrective action, and is not part of preventive action.

As already mentioned, preventive action is action taken on potential nonconformances to prevent their occurrence.

Do something to make recurrence stand out as what you are preventing on corrective actions.
I found that many D7 still addressed back the preventive of D6. Eg, including the D6 rootcause as part of checklist. So this does not address the potential non conformance, as per 8.5.3, is this NC against ISO9001?
 
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