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Preventive Action Process question - ISO 9001 Clause 8.5.3

M

mguilbert

#1
ISO 9001: 8.5.3 states "... determine requirements for
a) Determining potential nonconfromities and their causes,..."

Maybe I am reading into this to much or I am having a difficult time define the requirements for determining potential nonconformities and their causes. Currently I am thinking along these lines.

Preventive Actions may be identified during: management reviews, trend analysis, etc.

But I do not believe it is that simple and these do not seem like requirements to me. Any help would be greatly appreciated.
 
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Helmut Jilling

Auditor / Consultant
#2
ISO 9001: 8.5.3 states "... determine requirements for
a) Determining potential nonconfromities and their causes,..."

Maybe I am reading into this to much or I am having a difficult time define the requirements for determining potential nonconformities and their causes. Currently I am thinking along these lines.

Preventive Actions may be identified during: management reviews, trend analysis, etc.

But I do not believe it is that simple and these do not seem like requirements to me. Any help would be greatly appreciated.
You are doing fine, but take it broadly. Preventive actions are like corrective actions, same format and approach. The difference is you do them before the problem blows up.

In other words, if you do nothing, it may likely become a corrective action. Look for situations which could likely become a problem which would require corrective actions, but deal with them proactively, ahead of time. They can come from any source - any source where you see a potential corrective action coming...
 
K

Kirin

#3
I am looking at writing a procedure for 8.5.3 Preventive Action for my company as well. I believe that it should follow the steps that are usually taken for Corrective Action i.e.

1) Identify potential non-conformities
2) Determine the causes potential of non-conformities (root cause determination)
3) Evaluate the need to prevent occurrence
4) Determine and implement preventive action
5) Record results of the actions taken
6) Review actions taken

I think i'm going to look at it from two perspectives: product related preventive action (we source all products from overseas suppliers) and process/procedure related preventive action (to view from an internal perspective).

I would say that in addition to your statement of preventive actions being identified in management review and trend analysis, it could also be highlighted through:

internal audit (opportunities for improvement),
discussions/correspondence with suppliers,
R&D departments if you have one
feedback from business development/sales/market research
industry related publications

If anything i have said is wrong, please correct me, or if anyone can add anything please feel free to do so!
 

Helmut Jilling

Auditor / Consultant
#4
I am looking at writing a procedure for 8.5.3 Preventive Action for my company as well. I believe that it should follow the steps that are usually taken for Corrective Action i.e.

1) Identify potential non-conformities
2) Determine the causes potential of non-conformities (root cause determination)
3) Evaluate the need to prevent occurrence
4) Determine and implement preventive action
5) Record results of the actions taken
6) Review actions taken

I think i'm going to look at it from two perspectives: product related preventive action (we source all products from overseas suppliers) and process/procedure related preventive action (to view from an internal perspective).

I would say that in addition to your statement of preventive actions being identified in management review and trend analysis, it could also be highlighted through:

internal audit (opportunities for improvement),
discussions/correspondence with suppliers,
R&D departments if you have one
feedback from business development/sales/market research
industry related publications

If anything i have said is wrong, please correct me, or if anyone can add anything please feel free to do so!
Your approach would fit the classic model, and should meet the requirements of the standard, the way you described it. Keep in mind, it does not have to be a separate procedure. It can be put into your corrective action procedure. There are different points of view, but the standard language follows the same format as corrective action. The main difference being that Preventives are proactive and done while the problem is still a potential issue.
 

qusys

Trusted Information Resource
#5
Your approach would fit the classic model, and should meet the requirements of the standard, the way you described it. Keep in mind, it does not have to be a separate procedure. It can be put into your corrective action procedure. There are different points of view, but the standard language follows the same format as corrective action. The main difference being that Preventives are proactive and done while the problem is still a potential issue.
Agree.
Risk analysis ( for instance by means of FMEA or whatever else methologies) could be instrumental and beneficial to preventive actions activity.
It could be inserted in the related procedure of the organization.:bigwave:
 

Randy

Super Moderator
#6
You are taking something simple like boiling an egg and turning it into something that cannot be described. It has to be no more complicated than the example below.

Corrective action....Rebuilding the house after the kids burnt it down when playing with matches


Preventive action....Seeing matches out on a table and placing them where the kids can't get to them.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Corrective action....Rebuilding the house after the kids burnt it down when playing with matches
Some (myself included) would question that. Corrective action, by definition, is preventing the recurrence of a nonconformity. Rebuilding the house will not prevent the fire from happening again.
 

Randy

Super Moderator
#8
Some (myself included) would question that. Corrective action, by definition, is preventing the recurrence of a nonconformity. Rebuilding the house will not prevent the fire from happening again.
Excuse me for trying to convey in the simplest of examples, I was totally incorrect in doing so.:frust:
 
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