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Certification Body insist on evidence of Preventive Action during Stage 2 audit

#1
I would like to seek forum members opinion regarding this Development Point raised by a certification body during stage 1 audit and i quote verbatim:

Results of Preventive Actions must be maintained and available e.g. PAR during stage 2 audit (8.5.3d).
 
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Randy

Super Moderator
#2
You can only maintain them if you have them, and nothing says you must have them, only that you control them according to 8.5.3
 

qusys

Trusted Information Resource
#3
I would like to seek forum members opinion regarding this Development Point raised by a certification body during stage 1 audit and i quote verbatim:

Results of Preventive Actions must be maintained and available e.g. PAR during stage 2 audit (8.5.3d).
Did he/she collected evidences during the audit that you have dealt with preventive actions but you did not consider as an input of management review?
Did he/she catch some evidences vs your documented internal procedure of preventive action?
Could you please attach the evidence that caused the ncn?:bigwave:
 
#4
Hi Randy,
the issue here is the auditor insisted on preventive action records being made available as you can see in the development point sentence. he said that there has to be some evidence of preventive actions when he comes for stage 2 audit! i was shocked at this finding.
 
#5
Did he/she collected evidences during the audit that you have dealt with preventive actions but you did not consider as an input of management review?
Did he/she catch some evidences vs your documented internal procedure of preventive action?
Could you please attach the evidence that caused the ncn?:bigwave:
- preventive action was addressed in the management review. There was no preventive action identified at that time. The system been effective for 2 months only.

- He did not find anything that should have been recorded as preventive action. it was more like his own opinion. he said that there are plenty of preventive actions opportunities in any QMS including things like safety. to me that is just plain stupid. it's like asking an organization to just put up a Preventive action request for the sake of having a preventive action record.
I actually posed this finding to one of the auditor's colleagues and he was actually stumped at the development point.
 
Last edited:

harry

Super Moderator
#6
Hi Randy,
the issue here is the auditor insisted on preventive action records being made available as you can see in the development point sentence. ............
Call the Certification/Technical Manager of your CB and check with him. I know there are auditors who interpret things this way but not from the CB's that I know.
 

qusys

Trusted Information Resource
#8
- preventive action was addressed in the management review. There was no preventive action identified at that time. The system been effective for 2 months only.

- He did not find anything that should have been recorded as preventive action. it was more like his own opinion. he said that there are plenty of preventive actions opportunities in any QMS including things like safety. to me that is just plain stupid. it's like asking an organization to just put up a Preventive action request for the sake of having a preventive action record.
I actually posed this finding to one of the auditor's colleagues and he was actually stumped at the development point.
Thanks.
If you have demonstrated that you have in place an activity for preventive action as you said but at the moment you do not have any of them, it is not a non conformity. It could have been an opportunity for improvement in this case.
Consider that this kind of requirement is also checked by an external auditor acrossed all over QMS processes of your organization. If he did not had evidence of ncn in this sense, the ncn could be appealed.:bigwave:
 

Jim G

Involved In Discussions
#9
ISO 9001 requires an organization to have a documented procedure for
preventive action. The combination of corrective action and preventive action documented procedures into a single QMS document is acceptable, but is not recommended. If these are combined, then it is important that the organization understands clearly the difference between the intent of corrective and preventive actions.
The Standard requires the documented procedure to include: How the organization determines potential nonconformities and their causes.
These may include:
• Trend analysis for process and product characteristics (output from the data analysis process).
• Monitoring of customer perception.
• Through planning activities for both predictable situations (e.g. due to
expansion, maintenance, or personnel changes – see also ISO 9001,
Clause 5.4.2b)) and for unpredictable situations (e.g. naturally occurring
problems such as hurricanes, earthquakes, floods etc.)
In my opinion, it's a valid non conformance in line with the Auditors guidance notes.
 

Randy

Super Moderator
#10
"Preventive actions shall be appropriate to the effects of the potential problems."

It's your decision as to whether or not something is "preventive". If everything were considered "preventive action" then all you would ever do would be that and nothing else...Krap, just look at it....a QMS implementation and 3rd party certification could be considered "Preventive action" Why? To prevent customer dissatisfaction of course

The line has to drawn somewhere and nowhere does 9001 toss out good old common sense and sound business management practices. From top management on down to the building custodians people make hundreds of decisions every day most of which are to keep something from happening, each and every one of them are "preventive", so should they all be documented, cause determined, have assigned reponsibilities, time frames and action plans? Absolutely not, that would be just plain stupid and anyone who says otherwise falls into the same category

In the end, the decision maker in this has to be the organization and not some knuckleheaded auditor trying to make organizations into his/her image
 
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