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I thought I would share this discussion between two of my auditors, to see if there are other opinions out there in Elsmarland, our internal discussion is ongoing.
Response:
Opinions welcomed!
8.4 of the standard requires documented procedures for analysis of data.
I have had many clients that do not have one of these and point to management review or the Q manual as fulfilling this requirement. I continue to write this up and each company continues to argue that they do not need a separate documented procedure if they describe the activities in the QM.
Then my question is why does the standard say documented procedure. Is the QM considered a documented procedure or do they need a separate documented procedure. And then if the QM is accepted then why does anyone have any documented procedures if they can all be in the QM.
I am writing this to ask your opinion on this because the [company X] desk study reveals no documented procedure for analysis of data and the management review does not address it.
I have had many clients that do not have one of these and point to management review or the Q manual as fulfilling this requirement. I continue to write this up and each company continues to argue that they do not need a separate documented procedure if they describe the activities in the QM.
Then my question is why does the standard say documented procedure. Is the QM considered a documented procedure or do they need a separate documented procedure. And then if the QM is accepted then why does anyone have any documented procedures if they can all be in the QM.
I am writing this to ask your opinion on this because the [company X] desk study reveals no documented procedure for analysis of data and the management review does not address it.
8.4 is clear in requiring a documented procedure, however, a company could have very clear definitions of how they determine, collect and analyze the data in another procedure. What is usually lacking when they don't do a specific procedure for 8.4 is the tie-in back to 4.1 (f). The company has to have clear metrics they are using for this data.
What is usually seen in Management Review is a report of the areas and no clear link to demonstrating the "improvement of the effectiveness" of the QMS. My concern is that a company doesn't seem to understand the importance of this analysis rather than just reporting.
What is usually seen in Management Review is a report of the areas and no clear link to demonstrating the "improvement of the effectiveness" of the QMS. My concern is that a company doesn't seem to understand the importance of this analysis rather than just reporting.
Opinions welcomed!
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