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7.5.2 - validation of processes, audit nonconformances and findings, special processes, quality manuals - structure contents and examples
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  #1  
Old 5th January 2011, 12:49 AM
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Please Help! List of Special Processes in Quality Manual

In recent audit we got an NC for not identifyin 'special processes' (caluse 7.5.2) in our quality manual. We operate & maintain a power station and many of our processes could fall in special process category e.g. de-salinating and purifying water, fuel atomization etc. All processes are automatic with different checks & controls, warnings, alarms, trip settings etc. backed by well documented inspection, calibration and maintenance regimes and are managed through operating manuals and operating instructions by well trained staff with traceable competency records. This is what we have elaborated in the manual. CB however dictates that we list all such processes and identify relevant procedures within the manual. If we go with CB finding we'd end up with a page long list of such processes and listing of more than 400 instructions in addtion to the list of technical and operating manuals. Expert advice requested.

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Old 5th January 2011, 01:08 AM
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Re: List of special processes in quality manual

Hello Sir.

You may be having a list of processes requiring validation, or perhaps a validation plan. This can be an objective evidence but certainly need not be in the quality manual. Perhaps the auditor must have meant quality management system. If you have a documented procedure for addressing your clause 7.5 requirements then this can be mentioned within the quality manual, and the validation plan can be a part within this procedure. Perhaps he is coming strongly on the 4.2.2 b) requirement of iso 9001, within the manual.

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Old 5th January 2011, 01:21 AM
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Re: List of Special Processes in Quality Manual

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<snip> CB however dictates that we list all such processes and identify relevant procedures within the manual. If we go with CB finding we'd end up with a page long list of such processes and listing of more than 400 instructions in addtion to the list of technical and operating manuals. <snip>
I would ask the CB to show me the requirement. If they told me it was in their (the CB's) requirements I'd boot them out the door and find a new registrar.

There is no standard that I am aware of which requires such a list to be in the company quality manual.

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Old 5th January 2011, 03:41 AM
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Re: List of Special Processes in Quality Manual

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In Reply to Parent Post by masimr View Post

In recent audit we got an NC for not identifying 'special processes' (clause 7.5.2) in our quality manual. We operate & maintain a power station and many of our processes could fall in special process category e.g. de-salinating and purifying water, fuel atomization etc. All processes are automatic with different checks & controls, warnings, alarms, trip settings etc. backed by well documented inspection, calibration and maintenance regimes and are managed through operating manuals and operating instructions by well trained staff with traceable competency records. This is what we have elaborated in the manual. CB however dictates that we list all such processes and identify relevant procedures within the manual. If we go with CB finding we'd end up with a page long list of such processes and listing of more than 400 instructions in addition to the list of technical and operating manuals. Expert advice requested.
Just for clarification - when you say you got an NC for 'not identifying the special processes in the manual' - are they actually asking for a list or are they asking you to explain/describe the fact that you have some processes which fall into this category?

Certainly, I agree with Marc that there is no requirement to have a list of them all in the manual - or anywhere else for that matter - but if you have a traditional manual in which you explain how each of the clauses will be met, you should probably explain the fact there are some of these processes and I personally would give 1 or 2 examples. Plus I would mention some of the methods of controlling them.

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Old 5th January 2011, 04:10 AM
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Re: List of Special Processes in Quality Manual

masimr
As I said in your previous question
Management review input and output the requirements for a QM are very limited.

As others have said what clause is stated in the NC

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Old 5th January 2011, 07:06 AM
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Re: List of Special Processes in Quality Manual

Thanks guys. Marc, CB auditor actually asked me to list/identify the special processes and linked procedures, saying that this is what he would look for during the next audit. I most certainly agree with the booting idea but my manger, who has no clue of any standards i.e. ISO 9001, 14001 or any other, thinks that CB is doing a great job.
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Old 5th January 2011, 10:00 AM
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Re: List of Special Processes in Quality Manual

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In Reply to Parent Post by masimr View Post

Thanks guys. Marc, CB auditor actually asked me to list/identify the special processes and linked procedures, saying that this is what he would look for during the next audit. I most certainly agree with the booting idea but my manger, who has no clue of any standards i.e. ISO 9001, 14001 or any other, thinks that CB is doing a great job.
This is an example of "do as I say" not what the standard requires.

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Old 5th January 2011, 10:16 AM
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Re: List of Special Processes in Quality Manual

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Thanks guys. Marc, CB auditor actually asked me to list/identify the special processes and linked procedures, saying that this is what he would look for during the next audit. <snip>
Like I say, I would ask the auditor to cite the requirement for there to be a list as you describe in the quality manual. If that doesn't work I don't know what to tell you other than that I have seen companies that followed the 'requests' of auditors for them to do things that were not required by a standard and the next thing you know it's all about what the auditor wants to see rather than the requirements. Things can get ugly fast.

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