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ISO 9001 Clause 6.3 Infrastructure - Preventive Maintenance Requirements

Helmut Jilling

Auditor / Consultant
#21
All that the standard expects you to do is to:
Determine
Provide
Maintain
The needed infrastructure.
The standard here has been so lenient that it does not ask for any requirements of records.
If there are evidences that the QMS performance is adversely effected due to lack of Maintenance of provided infrastructure, such can be audit evidences for a NC. The rest like the checklist, PM, b/d M, records, any maintenance procedures, critical parts inventory holding, etc etc ... are all your own inclusions. If you have brought them into the QMS, then please respect the same. There is no need also to document how you will perform the maintenance process either.
Post #18, says it all so well ...
I agree the procedure is not a required procedure. But, I would expect to see some sort of record that maintenace of equipment was performed. But the checklist could be sufficient.
 
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Helmut Jilling

Auditor / Consultant
#22
Okay, got it! So he had no hard evidence that the PM process was ineffective but he wasn't overly impressed with the checklist we maintained and that probably did not provide a lot of control over PM, but I revised the checklist to get a lil more technical. Hopefully that should solve the problem and as for changing the procedure ( I hate doing so without a strong cause) should I add that PM is being controlled by maintaining check lists as records? That bit isn't mentioned in the procedure but I think with that being said, he can't say that we are not controlling the process.

Thanks!
I still think that you are chasing a nonconformance that you do not fully understand,,,I don't either....so how are you going to root cause the failure, when the failure is not clearly stated. You can guess at what you think he wants to see, to be agreeable. Or, you can request a clarification from the auditor...I mean, I don't even understand what that gibberish was supposed to mean... Or, you can officially appeal it and ask the registrar to review it.

You also have the option to request a different auditor be assigned if you feel this one does a lot of this kind of finding. If you feel you need to.
 

roneljdsilva

Involved In Discussions
#23
Okay let me clarify a few things. It was sent to me as an observation but he did demand a corrective action and a root cause analysis for it and so I am treating it as I would a finding. I actually do not clearly understand what he meant by procedure not identifying controls when I think we have some controls over this process. Also I am trying to get our QMS compliant to API Q1 which demands a documented procedure and control of records. But then again, they do not seem so strict about this whole process.


This audit was a supplier audit that they conducted on us as we supply some drilling equipment over to them every now and then so I was guessing I might as well just revise my records with a better checklist and revise the procedure to include the controls we have already been taking.

I appreciate the help I am learning so much from the Cove, I'm really grateful. And Helmut, I did receive another finding regarding training. If I could send you a message, could I get this clarified? Thanks.
 

Helmut Jilling

Auditor / Consultant
#24
Okay let me clarify a few things. It was sent to me as an observation but he did demand a corrective action and a root cause analysis for it and so I am treating it as I would a finding. I actually do not clearly understand what he meant by procedure not identifying controls when I think we have some controls over this process. Also I am trying to get our QMS compliant to API Q1 which demands a documented procedure and control of records. But then again, they do not seem so strict about this whole process.


This audit was a supplier audit that they conducted on us as we supply some drilling equipment over to them every now and then so I was guessing I might as well just revise my records with a better checklist and revise the procedure to include the controls we have already been taking.
Well, that changes the story significantly... you should have stated that at the outset. My answers were directed at the normal CB audit scenario. If this is a customer audit, then the only option you have is to ask for clarification, explain you don't fully understand what the finding is requesting, then put it in place. I agree what he is looking for can be beneficial, it is just over and above the minimums that ISO 9001 requires.
 
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