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 ISO 9001/4:2000
 Transition from 1994 to 2000
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Marc Smith Cheech Wizard Posts: 4119 |
posted 11 June 2000 08:59 AM
   
From: ISO Standards Discussion Date: Mon, 5 Jun 2000 14:00:08 -0500 Subject: Re: Conflict Of Standards Use/../Miller/Hartman From: [email protected] Ray Miller queried: "How they are handling 8.3, I don't know..." Ray, Our company has recently completed the effort to revise their documentation to be compliant with the INTENT of the DIS. Our documentation was NOT renumbered or reformatted (there's a cross reference in ANNEX B of the DIS), and no major revisions were made to the way we have been conducting business since 1992. The DIS revisions make no great change to the INTENT of the previous versions of ISO 9001 (i.e. Continual Improvement - Always a part of (and a result of) the Management Review, Internal Audits, and Preventive Action requirements; Customer Satisfaction - Due to the fact that the wording in the DIS states that you can measure "satisfaction and/OR dissatisfaction" this is virtually no different than the previous requirement for handling customer complaints. And to address your query directly, we continue to comply with the intent of the previous revision (especially since DIS 8.3 is one of the items that Jack West (Chairman of the TAG) stated will be corrected in the FDIS). Don't let the consultants and other neighsayers fool you, there REALLY are NO major changes or additional requirements to the new revision. David Hartman IP: Logged |
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isodog Forum Contributor Posts: 51 |
posted 13 June 2000 12:32 AM
Are you going to continue to attach stickers to gages? This is no longer required, IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 13 June 2000 12:38 AM
I'm doing some work for Ford in Sharonville. Not 1 gage has a cal sticker - they are registered to ISO9001:1994/QS-9000. Any comments? IP: Logged |
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Tom Goetzinger Forum Contributor Posts: 123 |
posted 13 June 2000 10:59 AM
What do their procedures say? I don't believe that the standard ever required calibration stickers on all calibrated gages. It just requires a method of identifying which gages are calibrated, so that only those are used when product quality is affected. Calibration stickers are a commonly accepted method of doing that, and maybe the easiest, but certainly not the only. ------------------ IP: Logged |
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isodog Forum Contributor Posts: 51 |
posted 13 June 2000 11:19 AM
You are correct! Dave IP: Logged |
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ALM Forum Contributor Posts: 80 |
posted 13 June 2000 11:27 AM
quote: Though I have fought with auditors in the past over this... this year we finally relented and actually labeled our gages, etc... that are NOT used for inspection/test results as "not for calibration. We have always "identified" our inspection and testing gauges with a sticker... and specified that "only those with the appropriate calibration stickers and that are on the calibration list... may be used to make quality decisions... blah, blah, blah..." We were CONSTANTLY busted for not labeling everything else "not for calibration." (This, from a reputable auditor at a well-know registrar... BSI) Just my $.05 ALM [This message has been edited by ALM (edited 13 June 2000).] IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 13 June 2000 01:23 PM
quote:This has been my experience. IP: Logged |
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Tom Goetzinger Forum Contributor Posts: 123 |
posted 13 June 2000 05:20 PM
Have you tried including in your procedures the statement that unless identified as calibrated, all gages are assumed to be for reference use only? I believe that is the key to not labeling all gages. "Identified" could mean bearing calibration stickers, or marked in some other way, but identifiable to a specific instrument on the calibrated instrument list. [This message has been edited by Tom Goetzinger (edited 13 June 2000).] IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 14 June 2000 01:25 AM
quote:As I stated above, I have run into the 'sticker everything' mentality. For some years I have used the procedure vehicle to avoid labeling everything. It does work, but there are some idiot auditors who don't like to buy it. You gotta ram it down their throats. IP: Logged |
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Tom Goetzinger Forum Contributor Posts: 123 |
posted 14 June 2000 09:35 AM
I was able to convince our auditor that it did not make good business sense to label all gages. Because this is true in our environment, and our auditor is a reasonable, experienced individual, I did not have to ram it down his throat. IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 14 June 2000 01:32 PM
quote:Consider yourself lucky. IP: Logged |
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David Mullins Forum Contributor Posts: 248 |
posted 15 June 2000 03:04 AM
Reference/indicative/what ever - how does the operator know if the equipment/gage is out of calibration or not, if there is no easily accessible information, e.g. a sticker? ------------------ IP: Logged |
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Tom Goetzinger Forum Contributor Posts: 123 |
posted 15 June 2000 09:56 AM
As I indicated in my 13 June input, our operators know that if it is not marked as calibrated, it assumed to not be; its that simple. We have many areas in our plant where calibrated gages are not required as dimensions are reference in nature. Remember that a calibration sticker indicates when the gage was last calibrated and does not ensure that it is still in calibration. I'm sure we've all seen cases of gages calibrated yesterday and dropped today; sticker is still there, but the gage isn't right anymore. [This message has been edited by Tom Goetzinger (edited 16 June 2000).] IP: Logged |
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David Mullins Forum Contributor Posts: 248 |
posted 15 June 2000 08:41 PM
Tom, I need convincing (I want to be convinced!)- examples are good. I had read your June 13 input, but I suppose I'm one of the "idiots" Marc refered to in that I see that even indicative gages are used to make decisions that affect quality. Do you have any examples where a gage does not affect quality? ------------------ IP: Logged |
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AJPaton Forum Contributor Posts: 73 |
posted 15 June 2000 10:50 PM
David, not certain if this fits as an example of gages not affecting quality, but... We're an assembly plant, pre-fabricated parts are made, and we assemble per drawings. Drawings indicate mounting locations, and holes are in the prefab parts at 1.5" intervals. We don't calibrate the tape measures, since the parts won't fit together if you're 1.5" off. Currently it flies with our auditor. AJP IP: Logged |
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barb butrym Forum Contributor Posts: 637 |
posted 16 June 2000 07:38 AM
as an auditor...you don't have to jam it down my throat...but i will chew on it a while....some things are obvious and not an issue...but if I see multimeters or other typically calibrated measuring stuff....I want to see a reference only sticker or the like....stuff does have legs sometimes......and if its not tagged can end up in use elsewhere ...... for acceptance.... unique gauges are a different animal. Ya gotta play each scenario out...... IP: Logged |
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Jim Biz Forum Wizard Posts: 275 |
posted 16 June 2000 08:51 AM
quote: I have one (I think?)- we get raw steel bars - mill deliveres them in 20 foot lengths But I do have a simillar perplexing question - even If I calibrate a tape measure - how do I calibrate the "eye" that is reading it? Plus minus full inches are easy - plus-minus 0.060" is again another story even with a calibrated tape ?? Comments? Regards IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 16 June 2000 10:17 AM
quote:I haven't had a client who has used 'For Reference Only' stickers or other such nonsense since 1996 (either on M&TE or documents). I strongly advise against them. Employees are 'trained' to know how to determine if something is controlled or not in accordance with their procedure(s). For example, if a piece of M&TE does not have a cal sticker, by default it cannot be assigned and/or used for inspection / test. They don't need a sticker that says "For Reference Only". The people aren't that stupid. IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 16 June 2000 10:24 AM
quote:Exactly! IP: Logged |
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isorin unregistered |
posted 16 June 2000 11:36 AM
quote:I haven't had a client who has used 'For Reference Only' stickers or other such nonsense since 1996 (either on M&TE or documents). I strongly advise against them. Employees are 'trained' to know how to determine if something is controlled or not in accordance with their procedure(s). For example, if a piece of M&TE does not have a cal sticker, by default it cannot be assigned and/or used for inspection / test. They don't need a sticker that says "For Reference Only". The people aren't that stupid.[/B][/QUOTE] The people aren't that stupid. - ? Oh...YES? And we are talking about electronic field of activity (telecommunications to be exact). Only explaining the meaning of ISO9002 can help you loose 5-10 pounds, so... think again about ''stupid'' ppl. IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 16 June 2000 02:19 PM
In my experience mentally handicapped (or physically handicapped) doesn't mean stupid. Nor does it mean untrainable. In addition, if you are supposed to assign personnel to jobs which they are qualified to do. If I had a client with people who were so 'handicapped' that they need a sticker or other label to tell them whether or not they could use an instrument to measure their part and they were untrainable, I would see that as a special case and take appropriate measures. I've had plenty of clients with handicapped people and I guess I and they have been lucky - they have been easily trainable. Severely handicapped would not be placed in a position where that would be a problem (remember, they have to be 'qualified' to do a job. I think you're pulling shit out of the air here to make a silly point for stickers by citing handicapped people and insinuating they are stupid and/or not trainable. Most of the problems I have had with clients were those with unions where the people were apathetic, not stupid, and too lazy to care if what they used was calibrated or not - it had nothing to do with how the M&TE was marked. 'For Reference Only' stickers are totally unneccessary and I haven't seen them used in over 4 years. If you have a special case where a bunch of 'stupid' people are measuring things in your company and they cannot be trained to know that they can only use equipment with cal stickers, I would say you have a most unusual case and my concern would mostly be whether you assigned qualified people to do that job. I stand by my statement: people aren't that stupid. They may be that lazy, but not that stupid. My clients haven't used stickers like that in going on 5 years and every client I have had has passed their registration audit first time around - so I think it is acceptable not to sticker everything in the company. In fact, several companies I have seen (including Ford) have had NO calibration stickers at all. The operators use what is at their station and it is not their responsibility to know if something is calibrated or not. It is the responsibility of the calibration folks to ensure equipment at stations was calibrated. But if you believe in stickers, so be it! Use them. IP: Logged |
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isorin unregistered |
posted 16 June 2000 02:36 PM
Marc, I quote :''Severely handicapped would not be placed in a position where that would be a problem (remember, they have to be 'qualified' to do a job).'' Even if they are in Special Work Center for H. Ppl? OK I appologise for misunderstood : 1st I do not agree with stickers. 2nd My intention was only to show that sometime you are (like it or not) in position to deal with exceptions(and not pushing shit) 3rd I do agree with the fact that ppl are only lazy not stupid. Final : The fact is that in the real world most ppl are lazy. And BTW - on a personal note - I come to this board (not so often, I agree) because I can follow real discussions between ppl that have a certain degree of know-how and culture - not to find someone that I respect telling me that I pull shit. IP: Logged |
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Jim Biz Forum Wizard Posts: 275 |
posted 16 June 2000 02:57 PM
Whooa - (how do I say this without offending anyone?) What was it that Barb posted about another discussion awhile back "ok guys tell us what you really think? I have 2cents that I hope makes sense -- there are times that (joke-joke) Dosent mean we always need to agree & dosen't mean we need to get overtly sensitive because we disagree? Clear to me that this one has more than one right answer depending on your paradigm (sp?) of how it works for you... Regards IP: Logged |
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isorin unregistered |
posted 16 June 2000 03:30 PM
To JimBiz :This is not about to agree or disagree, about the right to free speech, etc. Each one have the right to express his own opinion but I think that the terms can be polite. I mean would do like to tell you now that you are a stupid s**t who don't know how to spell ''ridiculous''(see REDICULESS )? - you see this is not polite. Polite is to sit back and shut up my mouth because we are not all born in England or US and making mistakes is natural. Enough for me and I wish you all a very nice day and a good weekend ! IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 16 June 2000 06:52 PM
Having a sister who has been 'disabled' all her life I really took offense at what I considered a silly and offensive example. Now, you can reply in any way you wish. If I was a prick I'd just erase messages that personally offend me and be done with it. I do respect your opinion. Using the word SHIT is not a big deal to me. In these forums everyone has the access to post what they want. And as you know typing words does not carry across the 'feeling' which is why 'smiles' and such are often used. I said you 'pulled shit out of the air' (I did not cally anyone a 'stupid shit' or any such like, by the way) because you cited a very, very unusual 'case', to say the least, and implied people are stupid. Let's face it - you were streching it to use the case you cited. But I didn't erase your message - rather I replied to it. You implied (as I interpreted it) mentally handicapped people are too stupid to be trained. My comment may have been offensive to you because I used the word SHIT (someone in another thread recently said I mauled someone in a response) in a response to you. However your implication that handicapped people are stupid was by far and away more offensive than anything I could have said - in my opinion. Often in internet forums responses in threads do get quite heated. These forums here are, I believe, relatively mild and there are not that many 'heavy' responses. But there are some passionate responses and there will be more in the future. It's the nature of the medium and of people. If this is a problem for anyone I suggest you not participate. About the only adjective/noun I do object to is spelling out the F word. Yes - on these forums there will be passionate disagreements in the future and there will be misunderstandings as well. Anyone who is personally offended may want to stick to other quality related forums such as the ASQC's forums. As a last 'heavy' comment, which none of you may like, this is NOT an issue of 'free speech' here. I have invited all of you 'into my livingroom' as friends and guests. I fund this out of my pocket and maintain it with my own time. It is not a public utility or organization. No - I do not censor and I have erased very few messages. I do not subject you to advertisements. I go out of my way to snag posts I think are interesting and/or controversial as 'feed' - just as this thread was started with - to put forth some ideas for us all to chew on. Many times I post things I do not even agree with just to provide an alturnative view. These forums are my attempt at an open, free (as in no fees), and unbiased information resource. MY gain is as I read every message/post (which I actually do) I typically learn something new or another way of looking at things. I cannot thank enough folks like Kevin, barb, David, Laura, AJPaton, Tom, Ken, Jim Biz, John, Roger, Jerry Eldred, Andy --- heck - there are lots and lots of people I could mention - provide very valuable insight and understanding into issues. Everyone continues to educate me. And they (and sometimes I) help out people every day who are having problems. Even Allan had some good input from time to time between advertisements. If you can tolerate some 'passionate' posts, you can learn a lot here. If a few words like SHIT disturb you, or if your ego is easily bruised, this may not be the place for you. Now - let's get the hell back to the subject at hand. IP: Logged |
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Jim Biz Forum Wizard Posts: 275 |
posted 19 June 2000 07:40 AM
Subject at hand: I am aware of 1 or 2 companies in out area that have actually implemented the elements of the 1994 standards... with no real intention of being registered - they knew they needed a quality system and have put the elements to work for them ... it will be interesting to see what if anything they change internally due to the newest versions.. Regards IP: Logged |
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Oscar Forum Contributor Posts: 13 |
posted 19 June 2000 11:56 AM
I think the issue of tagging instruments that are not calibrated may be a carry over from the requirements of the old calibration stadanrd (45662). Para. 5.10 stated "Items not calibrated to their full capability or which have other limitations of use, shall be labeled or otherwise identified as to the limitations." Our quality system still requires tagging of instruments that are not calibrated. We have put exceptions in our procedures excluding wall clocks, fire system gages, etc. from this requirement. ------------------ IP: Logged |
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isodog Forum Contributor Posts: 51 |
posted 19 June 2000 08:01 PM
Well! Since I started all this c**p (I'm tying to set a good example here)about calibation stickers, I'd like to make a point. There is significance in the fact that the company (not suppler no more) is NO longer required to (4.11.2d) "Identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibation status." It just ISN'T there in the ISO 9000:2000 DIS. Are you all going to continue to use stickers, or is there an alternative? By the way, I can get passionate about a good wine, the Iowa Hawkeyes, the right lover or five inches of fresh powder at 7:00 in the morning, but NOT this stuff. Get a life! Dave IP: Logged |
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Jim Biz Forum Wizard Posts: 275 |
posted 20 June 2000 07:54 AM
Are you all going to continue to use stickers, or is there an alternative? I don't plan to (and really never did) sticker "every" insturment in the plant...(we dont use "For reference only stickers) The alternative we use are manufacturers identification numbers traced back to our calibration database.. Current condition, history & status verified when the device is "checked out" of the tool crib prior to use. I really think this all boils down to "who controlls the actual calibration of the device" If the employee is qualified to calibrate his own - then there should be no reason that he can not calibrate on either a set date or frequency that is appropriate and turn in the information to be recorded - sticker or not. Jim IP: Logged |
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John C Forum Contributor Posts: 134 |
posted 20 June 2000 02:34 PM
A relevant point is that this is not a case of either/or. If we choose to use stickers, then this is either for an extra level of protection or to reduce overall costs. We still have to hold records and identify items. The choice to invest money in the stickers process should be made on the grounds that there will be a positive return in value in reduced cost or customer satisfaction. This is the basis of the decision, not whether the auditor is for or against. Personally, I favour the stickers. My experience tells me that most people need them to maintain customer satisfaction and that they reduce the cost, not add to it. I think Barb's message is similar, based on her wide experience. I'm surprised that some people are hostile towards stickers. Maintaining stickers is such a small fraction of the overall cost and, if the auditor asks just once, to be taken to see the records instead of just checking the sticker, then Auditor, Guide and Supervisor will all treck across the plant and the half hour that it takes will negate the whole year's savings in time spent sticking on and on sticker material. Of course, if your equation comes out the other way, then don't do it. But, if you get into an argument and don't have management's support, they'll probably overrule you - they're more scared of the registrar than they are of you. Better to save yourself for the day when there's something worth making a stand for. rgds, John C IP: Logged |
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Wendell Goodson Lurker (<10 Posts) Posts: 6 |
posted 20 June 2000 05:15 PM
This is our reply to TC 176, and it was published in the ISO-900 + ISO 14000 news letter for the month of june. I guess that we differ a little from your views. Wendell Goodosn
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isodog Forum Contributor Posts: 51 |
posted 21 June 2000 11:39 PM
No question their heads are in the wrong places. Any other clever observations? IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 24 June 2000 05:04 PM
quote:Just a comment... Using ISO9K as a tool makes sense. Doing it because your customer requires it is typically only a financial decision. I would expect more from a company doing it because they see opportunity for improvement rather than as a customer requirement. I'm not sure I understand what you mean when you say "...what if anything they change internally due to the newest versions..." IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 24 June 2000 05:13 PM
quote:Make a cross-reference matrix. Why would you rewrite all (or any) of your procedures?  Document tiers are a convenience, not a requirement. All I would rewite is your systems manual - a 1 day job. If all your procedures and such are that dependent upon structure you goofed when you developed your systems documentation.IP: Logged |
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Jim Biz Forum Wizard Posts: 275 |
posted 26 June 2000 07:30 AM
quote: Marc Just to clarify - as I understand it they have implemented according to the 1994 version.. IMHO they may or may not "change internal documents structures or recording practices" (what difference would it make to update internal system documentation and practices to the 2000 write-up? If registration isn't the goal) (Edited to correct quote code) [This message has been edited by Marc Smith (edited 26 June 2000).] IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 26 June 2000 08:16 AM
If the company implemented ISO9K to 'better' the company and not to register I personally see no reason for them to 'update' to the 2000 version. Thus I see no reason to "change internal documents structures or recording practices". The 2000 version of ISO9K only further bastardizes (my opinion) the standard towards the BullSh_t Zone. Customer Satisfaction my foot. Any company which does not satisfy its customers deserves what it gets and no standard will effectively force a company to do so. This is a carry-over from QS-9000, a customer requirement - not a 'standard. Since QS9000 is a customer requirement it shouldn't surprise us that it requires a supplier to 'please the customer' but Customer Satisfaction has no place in ISO 9001. IP: Logged |
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isodug unregistered |
posted 01 July 2000 12:22 AM
Marc, Marc, Marc. Customer satisfaction has NO place in ISO 9000? Why else, on earth, would you bother with a quality management system? These things take time, cost money (I know Crosby sez it's free, but that's b****it). In fact, Customer Satisfaction turns out to be the definitition of quality! Even if your parts don't conform to requirements, if you customers are happy, you have a quality product. Do you get it? Dave IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 01 July 2000 03:39 AM
quote:I guess I have to ask if YOU get it. Any company that does not attend to customer satisfaction without a specification telling them to is - well, I hesitate to call it doomed, but it's a very poor way to run a business. Companies improve their quality systms for many reasons. Typically part of the motive is profits and, by default, customer satisfaction. Are you telling me you need a specification like ISO9001 to direct your company (by requirement) to consider and address customer satisfaction? IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 01 July 2000 03:43 AM
quote:Pretty interesting statement. But I disagree. IP: Logged |
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isodog Forum Contributor Posts: 51 |
posted 09 July 2000 11:39 PM
Well, try this out. You get a call fom the chief engineer of your best customer. "From today forward the framis on the 1243 widget needs to be 0.0003 overcise. We have to allow the extra in order to mate with the new material. Can I get a print change or a dieviation?" you ask. "Maybe in three months!" he replies. "I'm up to my a*s in alligators over here. This is one of 348 changes we're making for Ford since they decided to create a 2000 1/2 model because of poor sales. And I need the parts ASAP." Do you make and ship the the 0.0003" oversize framises? (y) Are the parts out of spec? (y) Do they satisfy the customer? (y) Are they poorer quality parts than the ones you made to spec yesterday? (n) Dave IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 10 July 2000 06:59 AM
quote:No - they are not. The telephone conversation with your customer was for all intents and purposes a verbal requirement change which is (at heart) a contract change/revision. I assume you documented the call, who authorized the change, the date of first shipment, etc. Your change system should have provisions for this type of change since it's so common in audtomotive. The system should provide for follow-up on your end. You may never get a revised print, but you have evidence of the customer requested change. I don't see a problem here - typical automotive pro-active  business as usual.IP: Logged |
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Gokhan unregistered |
posted 11 July 2000 06:16 PM
Dave Small percent of customers turn to the manufacturer or service for their opinion. Your opinion was common in 1970s in USA manufacturers as they were selling what they produces. But the compotitive products from Japanese manufacturers with TQM has changed the mentality. IP: Logged |
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AJPaton Forum Contributor Posts: 73 |
posted 12 July 2000 08:31 AM
Question: If you want a marked up print, and your customer won't provide it, what's keeping you from doing it? Send a copy to the customer to close the loop on the process and you are being proactive. You have to mark up the prints for your use anyway, so giving the customer a copy of what you're building to reduces the risk of it being rejected by their incoming inspection. AJP IP: Logged |
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isodug unregistered |
posted 15 July 2000 12:37 AM
I'll say it again, I'd rather have a satisfied customer than conformance to specifications! Dave IP: Logged |
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lmfoong Forum Contributor Posts: 11 |
posted 12 September 2000 12:06 AM
Dear Marc, I wish to seek better understanding of the requirement of 8.3 which requires organization to measure customer satisfaction and/or dissatication. I agreed that the 1994 version somewhat measures this "new" requirement in the form of "customer complaints handling". However, would it be adequate to understand the customer only based on this information. My rationale is that customer who make complaints may not indicate dissatisfaction because those who does may still satisfied and continue to have business with you. And on the other hand, customer who don't make complaints may not be satisfied but choose not to complain. Based on the above, how would an ISO auditor or an organization determine customer satisfaction and/or dissatisfaction from the customer complaints. ------------------ lmfoong IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 13 September 2000 06:12 AM
quote:This thread has gotten pretty long - I'll start this in a new thread. [This message has been edited by Marc Smith (edited 13 September 2000).] IP: Logged |
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