I've just taken over a role that includes ISO9000 managment.

I want to have simple and effective processes which enable continuous improvement by the people in the process. I want to develop systems thinking within the company so that people critically think of how well processes work and and link together.

Our existing document control procedure requires the quality manager (me) to sign off and approve all procedures. Where these are in a specialised technical area then my review adds little. Publishing documents on our electronic document control system applies the document identifier and registers the submitter as document owner - so we have a document control process.

So that people can continually review and improve their processes, I don't see that I add any value in signing off their procedures - what I think is best is that new or changed procedures receive peer review.

So, cam formal document control requiring QM signoff live well with continuous improvement?

What are your comments and suggestions?

Brian H

Brian,

I think you can do it either way, whichever way works best in your situation is the way to go, IMHO. In the small companies I've worked in ( < / = 250 employees) I have required that I review all doc's (levels 1, 2, & 3) as part of the approval process. In some cases I cannot add anything on a technical level, but I make sure the "little things" are done -- a proper approval by the responsible person, hardcopy control (if required), electronic copy control, proper document numbering, an acceptable format with the required sections, etc. But I am sure you can also find a way to control these things even without the QM review if you work together with the affected folks and there is some discipline exercised. And there are probably folks who will post after me to explain how they do it!
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Edited by Marc: It would not take all the post because you had a 'formula' in there and without spaces it would not render as it passed through the php parser.

The QM here wants QA to sign off on all procedures. I wrote the Document Control Procedure to limit that requirement to level 2 procedures; level 3's and work instructions are departmental. He finally looked at a work instruction from manufacturing and discovered nobody from QA signed off on it. We are now discussing this very issue.:confused:

Helping Mike out since he's having problems posting. The problem seems to be the combination of the > , \ , and = symbols in front of the 250 employees. As you can see I changed to a tilda and it works. Here is the message he is trying to get out:

Brian,

I think you can do it either way, whichever way works best in your situation is the way to go, IMHO. In the small companies I've worked in (~250 employees) I have required that I review all doc's (levels 1, 2, & 3) as part of the approval process. In some cases I cannot add anything on a technical level, but I make sure the "little things" are done -- a proper approval by the responsible person, hardcopy control (if required), electronic copy control, proper document numbering, an acceptable format with the required sections, etc. But I am sure you can also find a way to control these things even without the QM review if you work together with the affected folks and there is some discipline exercised. And there are probably folks who will post after me to explain how they do it!

Mike S.

Thanks, Eileen, I couldn't figure out what I was doing wrong. Guess that's why you're super!:bigwave:

In several companies I've worked with, the QM signs off on the procedures from a doc control and format standpoint to ensure the procedures do not violate the rules for doc control. The content of the procedures is signed off by the department or activity manager.

Where these are in a specialised technical area then my review adds little.
This is often true. The QM is probably not the expert on the best way to perform the process. Leave that (and the corresponding procedure development) to the process owners. On the flipside, the process owners are probably not the best ones to determine if the document naming, numbering and format meets established conventions. This is where the QM review can be valuable. It is also the ideal time to add the document changes to the master list (if applicable).

If so, why would a quality professional need to do the latter? Seems to me like a pure admin task.
Not going to argue that Jim. Larger organizations I've worked with have had a "Document Controller" who performed the function. In other organizations they left it up to the QA or QM because "they have the expertise". Most "quality professionals" I know do have a bit of administrative duties on their plate. After all, we know that without such duties, the quality professional would have nothing to do but drink coffee all day! :rolleyes:

Jim Wade said:

* someone else can check naming conventions, page numbering, layout, typos, spellos and so on on?

If so, why would a quality professional need to do the latter? Seems to me like a pure admin task.

rgds Jim


I agree with you and db, Jim, a Q Pro need not be the one to do it, but in small to mid-sized companies this is often a hat the QM or his/her assistants wears in my experience. In one former company we had a Doc Control person who did nothing else, just doc control. Now, in IMHO, for a 250-300 person company this is not a full-time job unless you overcomplicate and "bureaucratize" things WAY too much to ensure your job security, which this person did. Getting a L3 procedure done, or getting a customer drawing accepted and filed, or getting a copy of a customer drawing, required about the same amount of paperwork and headaches as a home mortgage loan. It was crazy, and this person was sooooo protective of her ideas and her turf that she was eventually canned for her poor attitude and lack of cooperation. Seems to me, especially in today's "lean" (slimmed down staff) companies of smaller size, this is usually the QM's balliwick. JMO of course.

Not discounting the importance of a value added review:rolleyes: , which is another hazy description for a normal review, here's what and why we do what we do. All cognizant parties review a draft submitted by someone, agree on the content (no more value added review than that is normally required) and the procedure is put into an "official" looking format for final review and subsequent release. The fact that WE decided that a procedure is needed, to possibly fill in some technical gap that cannot be accomplished soley through on the job training, is what we consider "value added".:rolleyes:

Recognizing the Doc Control issue and formatting, which is the QA Mgr's job here because nobody does it better, :vfunny: the QA Mgr creates the document based on departmental input. The Review and Authorization block will contain the QA Mgr as the authorizer for the "Q" procedures, who is also the MR. In the case of selected Departmental level 3's, the QA Mgr is shown as the "Originator" and the respective Department Manager is the "Authorizer". It's a simple system.

And let's not forget the most important thing. It's always nice to see the QA Mgr's title on all documents, especially when he/she is the MR. :biglaugh: :biglaugh: Hey, that's why I have a job. Butt out, Jimbob!:agree:

Whether you can judge the technical merits, you should be able to look for adherence to the proper format, etc. More importantly, you should also review for references making sense, making sure the procedure is not duplicating anything already in the system. After all, shouldn't the MR be the expert on the QMS?
This doesn't relieve anyone else from responsibility, just a reality check.

tarheel said:

More importantly, you should also review for references making sense, making sure the procedure is not duplicating anything already in the system. After all, shouldn't the MR be the expert on the QMS?


Absofrigginlutely! Several times at our Steering Committee meetings someone decides to try and shine in front of the CEO by suggesting we should have a procedure for this and that. I have gleefully reminded that suit sucking individual that there is already a procedure that addresses that. "Are you sure? I don't remember seeing it." :vfunny: Then they are politely reminded that not only was it released but that I have a signed document from Everyone that they acknowledged the release and read and understood its contents as it applies to their particular position. O.K. undock those lips, Bucko! :p
Thanks for reminding us (me?) of that very, very important function of the MR (eliminating redundancy, accuracy of content and relation to the standard). That's probably the most important function of the Document "Authorizer" or "Approver". And, I would take bets that in the majority of small and mid-sized companies that person with the knowledge or familiarity of the standard has the "Q" in his title. Good one Tarheel.:D :ko: :smokin:

Thanks for all comments received - these have helped me develop my thinking here. My conclusions are:

As I don't have any admin support, the QMS has to be as self sustaining as possible. Therefore, peer review on non critical documents is OK, but business critical documents (e.g. sales terms and conditions) have to be approved and signed off by the relevant authority. This doesn't have to involve the quality manager but the QM needs to be informed of new document issue and changes via an updated document master list. This has to operate locally, with only limited involvement from me (I cover sites in USA, UK and Scandanavia)

Building a bureaucracy of inspectors and QMS administrators can be supported by insisting on strict document control. But this adds little business value, and in today's business world cannot be justified.

An admin role of "document controller" could be defined as part of general secretarial support.

The most important thing for me is that people are looking critically at how they work , looking for improvements and then drafting their own procedures (with increasing use of flow charting) and looking at how these processes and processes interlink with their internal/external customers and suppliers. Looking at document issue codes and revision history is an easy thing for any auditor and QM - but these nitpicky activities give quality management a bad name. When someone writes or improves a procedure on their own initiative and this is then criticised by for not complying with document control standards, then that can quickly kill continuous improvement and creativity.

It has been my experience that the QM's seem to have the best "feel" for the entire system. You're not just focused on one particular company function (i.e. finish grind). You may run into a problem if you are the one that gets the audit on Doc Control. You may not be deemed independant enough.

BrianHu said:

Building a bureaucracy of inspectors and QMS administrators can be supported by insisting on strict document control. But this adds little business value, and in today's business world cannot be justified.

Looking at document issue codes and revision history is an easy thing for any auditor and QM - but these nitpicky activities give quality management a bad name.

When someone writes or improves a procedure on their own initiative and this is then criticised by for not complying with document control standards, then that can quickly kill continuous improvement and creativity.

As this post is supposed to indicate what you arrived at after reading all the posts, I'm now curious.
"Building a bueaucracy of inspectors..............."
Where did that come from? I don't remember seeing that in any of the posts. Has anybody advocated that?

"Looking at document control issues............(nitpicking)........"
This is what a Document Control System does. Issue Codes and Revisions.....What else is there for an Auditor to look at? Critique the format and content? Does it meet the standard? How is that giving Quality a bad name?

"When someone writes or improves a procedure on their own initiative and this is then criticised..........."
Again, where was this derived from? The critical comments were for attempting to release procedures that were not needed because they existed in other procedures. Nobody bashed anyone for attempting to write a procedure. It's encouraged. You just have to follow some basic rules. Include your Supervisor, who will help to determine the Scope and Purpose. Get it approved and release it. That's all I saw.

Like you, I learn from everybody's posts. I also read the conclusions. I don't get yours. Is it possible that these were foregone conclusions and you were just waiting to make your point? You started the thread, so I assume they were not.

So, show me where I went astray in interpeting the posts and I won't think that it's a back door approach to a topic! :bonk:
:ko: :smokin:

The QM/rep review should address the missing "links" to the rest of the quality system references: N/C material, HSPPD, limited life, authority/acceptance, CAR, records......the format too, if that's the case .....and resourses and training, and maybe adding to the audit schedule...all value added to the system continuity...although maybe not to the process.

So yes they do work together

Brian,

You stated:
Therefore, peer review on non critical documents is OK, but business critical documents (e.g. sales terms and conditions) have to be approved and signed off by the relevant authority. This doesn't have to involve the quality manager but the QM needs to be informed of new document issue and changes via an updated document master list.
Would these types of documents, essentially sales contracts, etc., be "documents" or "records"? Are the "sales terms and conditions" different for each contract? Are they a "boiler plate" to be used consistently?

If they are specific to an individual contract, they would fall under the old contract review or now product realization provisions and would be considered records. The QM would then have no real concern in reviewing these documents.

Even if they are general documents and used as "boiler plate" for general understanding of contracts, they would not be subject to the same type of document control as the quality manual, procedures and work instructions. "Boiler plate" documents would more appropriately be considered "forms"...

Moreso than just confirming the format of the procedures, I think that the QM (or similar authority) must also review each procedure for general conformance to the standard. We have an entire Engineering dept. that would love to write a procedure stating "We do APQP where applicable", or "FMEA's are used at our discretion". And probably everyone here has a Maintenance Dept. that would eliminate all types of documents and records.

If there was no review by someone with in-depth knowledge of the standard, these procedures would be in place but would not conform with the requirements. Unless, of course, you work in one of those 'mythical' companies where every employee and manager has read and understood the standard.:biglaugh:

I think Dean hit it exactly! The value-added from a quality professional's review (especially one in the ISO system) would be, in my opinion, preventing "process improvements" that violate the standard, such as eliminating design validation, record keeping etc. A secondary benefit is ensuring standard document formats, revision levels etc. are followed.

Our company has elected to use this process: All Directors approve work instructions pertaining to their areas. The President signs the Quality Manual and any work instruction he dictates that needs to be in place. We feel that if the Director of the Department signs the document he will enforce the process in his area, creating the buy-in effect. (sometimes it still doesn't work).

My job, on the other hand, is to review all request for modifications to work instructions to ensure that the ISO and Customer's QMS requirements stay intact. We also hold meetings, send out e-mails notifying folks of the changes before they are formally released. The Director of Quality only signs for work instruction that pertains to his department.

Again, it's how your system best works for your environment.
I agree with others that have responded; Directors/Managers do not perform administrative functions; that's why they have folks like us - we can do it all! :rolleyes:

Regarding of this matter, I'd like to share my case as well. My company size is about 1200 staffs. Everyday, we have a moving of document control either new register, change revision or cancellation. On daily basis, the QMR have to review and sign for approve all document before launching in the document control network. It took amount of time to do.
However, last month after finish reviewing the system for improvement, we decided to change the way to control document
Group A: Cover all level 1,2, and 3 still need to be controlled as the traditional way by the reason that QMR should be the person who make sure that all document’s content comply with the standard.
Group B: Level 4 document about drawing, engineering spec, product spec and process spec must be review and approved by Quality Engineering Section. (in the past, this group took main portion for document moving)
As we implement the new method, we can see that QMR can save about 80% of his document review and approval time each day.

Regards,
QSMSO

Our company has elected to use this process: All Directors approve work instructions pertaining to their areas. The President signs the Quality Manual and any work instruction he dictates that needs to be in place. We feel that if the Director of the Department signs the document he will enforce the process in his area, creating the buy-in effect. (sometimes it still doesn't work).

My job, on the other hand, is to review all request for modifications to work instructions to ensure that the ISO and Customer's QMS requirements stay intact. We also hold meetings, send out e-mails notifying folks of the changes before they are formally released. The Director of Quality only signs for work instruction that pertains to his department.

Again, it's how your system best works for your environment.
I agree with others that have responded; Directors/Managers do not perform administrative functions; that's why they have folks like us - we can do it all! :rolleyes:

Rockanna,

Our system sounds identical to yours and it seems to work well. I too review requests for change from a QA persepective only. I try and maintain the onus of repsonsibility with the process or work instruction owner (buy-in effect). It is hard, sometimes, to keep my technical expertise under wraps when reviewing changes to documents.

Greg B

DeanP, do work at my company? You just described it perfectly! :vfunny:

As I've mentioned in a few other posts, I've just changed jobs. One of my first tasks when changing jobs is to get my hands around the company procedures and work instructions. Without that knowledge, I can't understand the quality system, much less lead it or encourage improvements.

Likewise, when documents are changed, I want to stay in tune with the changes, so I'm sure that the quality system continues to function as planned. I cannot begin to tell you some of the bloopers I've seen over the years that would have been implemented, had I not had the final review.

However, having said this, I am describing what happens in middle size companies, < 500 people. I think this is a whole different issue in very small and much larger companies.