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Gary E MacLean
Re: How do you decide what is a process, procedure or work instruction?
Of course the QM is more than that but it is certainly much more than the Quality Policy. The QM expresses Top Management's committment in ALL areas not just the few areas required to be covered as per clause 5.3. The QM expresses TM's committment to every single clause and requrement of the standard - one by one.
Slow down Jim, take it easy. I split that level up for many reasons. One of them is repeatedly expressed throughout this series of forums; that of having way too many documents. My level three consists of those work instructions (documents that provide specific HOW TO) that directly address an ISO requirement. My level four are those documents that you would like to have in your organization but are ones that ISO gives no direction for and has no guidance for. The registrar has no jurisdiction over the content of how you set up your coiling machine or how you distribute bonuses or how your safety committee meets and reports. These are not directly ISO subjects, thus they belong in a separate classification.
I suppose I should have been more clear. The level fours I refer to do not have to be audited by your registrar and generally will not even be reviewed. They do have to be audited according to your internal requirements. Since they do not address an ISO requirement they really can't be audited by the registrar. The registrar has no criteria with which to evaluate them with anyway. All the registrar can really do is audit the presence of a required instruction. Then the auditor can follow the operator as they conduct the activity but for the most part the auditor will be busy trying to audit the processes and related level three documents. I have successfully shaved many ten, 12 and 15 three ring notebook systems down to one binder using this rationale.
Come on Jim, tell me you didn't use that word. Your messin' with me right? I covered the rationale for the 'bifurcation' in the previous discussion.
Actually, the presence, the legibility, identifiability and distribution are every bit as important in the world of document control as is the content Jim. Immutable (if you must use those 'big kid' words) fact is fine but how it gets presented to the organization is very important and must be controlled.
I hesitate to even admit it but I have worked with over 100 different organizations and have yet to see one of them put the QM to any use of any kind. Yes, in most cases, the QM is issued to fill a requirement. Like it or not that's what is happening in the real world. Even those organizations who do issue the facade QM will usually still pay attention to the level two and three documents though. That is where the meat of any system really is.
Jim, I hope you don't take offense but I truly hope you don't write your internal documents the way you write your Elsmar posts. I did experience a registrar noncompliance for an organization using the phrase "...all employees practice good stewardship of the customer's product..." or something like that. Nobody knew what 'stewardship' meant; nope, not a single employee. The pretty word did nothing but guarantee a noncompliance for this company. Maybe 'effective' would have been every bit as effective...you think?
OK, I give up. Any takers on what Jim is talking about here?
Thanks for the very challenging critique of my post Jim. I just love this site - it makes us all think and try harder to understand what it is we are doing. I have probably gained more through my brief stint here on Elsmar than I have in the last half dozen seminars I have attended.
The commitment you refer to is generally captured in the quality policy; the QM should be more than that.
Of course the QM is more than that but it is certainly much more than the Quality Policy. The QM expresses Top Management's committment in ALL areas not just the few areas required to be covered as per clause 5.3. The QM expresses TM's committment to every single clause and requrement of the standard - one by one.
Why two tiers here? What's the difference between three and four?
Slow down Jim, take it easy. I split that level up for many reasons. One of them is repeatedly expressed throughout this series of forums; that of having way too many documents. My level three consists of those work instructions (documents that provide specific HOW TO) that directly address an ISO requirement. My level four are those documents that you would like to have in your organization but are ones that ISO gives no direction for and has no guidance for. The registrar has no jurisdiction over the content of how you set up your coiling machine or how you distribute bonuses or how your safety committee meets and reports. These are not directly ISO subjects, thus they belong in a separate classification.
They don't have to be audited?? How to you do part/process audits if you don't verify that the work instructions are being followed?
I suppose I should have been more clear. The level fours I refer to do not have to be audited by your registrar and generally will not even be reviewed. They do have to be audited according to your internal requirements. Since they do not address an ISO requirement they really can't be audited by the registrar. The registrar has no criteria with which to evaluate them with anyway. All the registrar can really do is audit the presence of a required instruction. Then the auditor can follow the operator as they conduct the activity but for the most part the auditor will be busy trying to audit the processes and related level three documents. I have successfully shaved many ten, 12 and 15 three ring notebook systems down to one binder using this rationale.
I'd like to learn more about your rationale for the bifurcation.
Come on Jim, tell me you didn't use that word. Your messin' with me right? I covered the rationale for the 'bifurcation' in the previous discussion.
I understand the need to control forms (usually tier 4 in a 4-tier system), but I don't see a need for controlling "unchangeable fact." If it's immutable, why does it need to be controlled?
Actually, the presence, the legibility, identifiability and distribution are every bit as important in the world of document control as is the content Jim. Immutable (if you must use those 'big kid' words) fact is fine but how it gets presented to the organization is very important and must be controlled.
Quality manuals that are "nearly a re-hash of the standard" are mostly worthless beyond the requirement to have a quality manual; why have a potentially significant document that serves no useful purpose?
I hesitate to even admit it but I have worked with over 100 different organizations and have yet to see one of them put the QM to any use of any kind. Yes, in most cases, the QM is issued to fill a requirement. Like it or not that's what is happening in the real world. Even those organizations who do issue the facade QM will usually still pay attention to the level two and three documents though. That is where the meat of any system really is.
The best quality systems I've seen are the ones where someone has set out to build an efficacious system, one in which the satisfaction of ISO requirements is a secondary consideration.
Jim, I hope you don't take offense but I truly hope you don't write your internal documents the way you write your Elsmar posts. I did experience a registrar noncompliance for an organization using the phrase "...all employees practice good stewardship of the customer's product..." or something like that. Nobody knew what 'stewardship' meant; nope, not a single employee. The pretty word did nothing but guarantee a noncompliance for this company. Maybe 'effective' would have been every bit as effective...you think?
but if you set out with banality and needless rigor aforethought, you'll wind up with a system that's banal and needlessly rigorous.
OK, I give up. Any takers on what Jim is talking about here?
Thanks for the very challenging critique of my post Jim. I just love this site - it makes us all think and try harder to understand what it is we are doing. I have probably gained more through my brief stint here on Elsmar than I have in the last half dozen seminars I have attended.