Hit for not reviewing System Suitability in Management Review

[Dawn]

I took a hit for not reviewing system suitability in Mgmt. Rev. (QS). I am compiling a list of all elements with their procedures and work instructions to review each one in meeting. Does anyone have any other way to cover this?
Thanks, Dawn

[Marc]

You have me on this one. I've never heard of a company being cited for not reviewing suitability.

I pressure my clients to have a management review check list. One for ISO is in the Elsmar.com/pdf_files directory - file name is Mgmt_rev.pdf It was for ISO9000 but can be easily configured for QS. I put this form together some years ago because I got tired of auditors nit picking about each line item. I'm not convinced you have to address every single procedure and work instruction - my clients have told the auditor this is a general conversation / discussion - that suitability was a consideration throughout. For example, "...we eqach consider suitability of our systems during every meeting as a normal part of our reviews. We do not, however, have a special session or part of our meeting where we individually discuss at length suitability of each system, it's procedures and work instructions. When a meeting member feels a system or element of a system is no longer appropriate (suitable), s/he will bring it up as a specific topic. If we all concur it is put on our agenda as an action item and assigned to the appropriate employee."

If I was going to respond, I would put 'Suitabbility of existing systems' as 1 line item on the management review form. I see no requirement to go theough each system and each of their elements (procedures, WI's, etc.) individually during a management review meeting.

Did the auditor state his/her expectations? If not, I would contact him/her and ask. You might even get it in writing (a bit antagonistic, though).

[Dawn]

His exact words (in writing) were "No conclusions documented in management review records on suitability of the system."
My fix was "A breakdown of every element is provided to assure there is enough documentation; too much documentation; if processes are still acceptable; and if they are adequate for what we are doing."
This is what he wnats to see.
I will download the pdf file. Thanks!

[Marc]

As I said, the pdf file is a simple form. I press the form (check list if you will) idea on clients to reduce nit-picking opportunities. Thjat said, the auditor question will be" Explain what criteria you use..." or something like same. The form does make you address each issue during the meeting, however, if even briefly, so there you go!

During our first ISO-9000 audit we were given a "concern" for the same thing. We solved this by stating that during our Annual Management Review meeting the Management Representive shall comment on his/her review of the Quality System in regards to its continued suitability and effectiveness in satisfying the requirements of...(see 4.1.3) A summary of these comments would then be captured in the meeting minutes. Remember to state what the conclusion of this review was within the minutes or you'll still get "dinked."

[Sam]

Dawn,
I received one minor and four "observations" for not adequatly reviewing "suitability and effectiveness".
I was told by the auditors and also at a seminar I attended; presented by a registrar, that each element of the standard must be evaluated for continued "suitability and effectiveness" a minimumm of one time per year.
Suggested suitable means for evidence of review should be in the form of a checklist; questions referring to suitability and questions referring to effectiveness.
At first I thought this might be a liitle bit of overkill, however the standard does not say how to do it, just do it.
My question; Could this review be combined with the audit process. Establish an audit schedule such that at the closing meeting the suitability and effectiveness could be addressed.

Feedback any one.

By the way, Marc, I used your management review pdf at my last audit and received rave reviews from the auditor.

[Marc]

Originally posted by Sam:
By the way, Marc, I used your management review pdf at my last audit and received rave reviews from the auditor.

It's just a simple 'helper' - I'm happy that it helped you!