The Elsmar Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Elsmar Cove Discussion Forums Main Page
Welcome to what was The Original Cayman Cove Forums!
This thread is carried over and continued in the Current Elsmar Cove Forums

Search the Elsmar Cove!

Wooden Line
This is a "Frozen" Legacy Forum.
Most links on this page do NOT work.
Discussions since 2001 are HERE

Owl Line
The New Elsmar Cove Forums   The New Elsmar Cove Forums
  QS-9000
  SYSTEM SUITABILITY

Post New Topic  Post A Reply
profile | register | preferences | faq | search

UBBFriend: Email This Page to Someone! next newest topic | next oldest topic
Author Topic:   SYSTEM SUITABILITY
Dawn
Forum Contributor

Posts: 245
From:St. Marys, PA
Registered: Sep 98

posted 07 January 2000 10:22 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
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

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 08 January 2000 07:04 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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).

IP: Logged

Dawn
Forum Contributor

Posts: 245
From:St. Marys, PA
Registered: Sep 98

posted 09 January 2000 10:04 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
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!

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 09 January 2000 10:15 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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!

IP: Logged

Al
Lurker (<10 Posts)

Posts: 5
From:Evansville,IN,USA
Registered: Jan 2000

posted 26 January 2000 07:16 AM     Click Here to See the Profile for Al   Click Here to Email Al     Edit/Delete Message   Reply w/Quote
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."

IP: Logged

Sam
Forum Contributor

Posts: 244
From:
Registered: Sep 1999

posted 26 January 2000 09:12 AM     Click Here to See the Profile for Sam   Click Here to Email Sam     Edit/Delete Message   Reply w/Quote
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.

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 26 January 2000 11:29 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
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!

IP: Logged

All times are Eastern Standard Time (USA)

next newest topic | next oldest topic

Administrative Options: Close Topic | Archive/Move | Delete Topic
Post New Topic  Post A Reply Hop to:

Contact Us | The Elsmar Cove Home Page

Your Input Into These Forums Is Appreciated! Thanks!


Main Site Search
Y'All Come Back Now, Ya Hear?
Powered by FreeBSD!Made With A Mac!Powered by Apache!