View Full Version : Nonconformance - How is this Top Management Definition of Nonconformances?
rdd007 24th October 2006, 08:48 PM I'm in a new job, and the ISO audit is coming up next month. I've got to get your input on this item, because it's very important to us ...
Top management has told me that "in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station." There are a few boxes or racks of parts that are scrap or rework at the workstations, and those are just thrown out or reworked when the operator or supervisor gets to it. They aren't tagged, except when an auditor is around ...
So, I created a poll to get your educated opinons :-) Tell me what you think.
Thanks.
Greg B 24th October 2006, 09:08 PM If that statement works for YOUR company then USE IT! but I personaly don't agree with it. This is the definition that I use:
NON CONFORMANCE
"To meet our customers’ needs and expectations, 'Our companys' products must conform to agreed requirements that include chemical, physical and sizing specifications, as well as packaging and delivery specifications."
A NON CONFORMANCE is caused when:
Product does not meet Specifications,
Product/Packaging/Delivery/Qty etc does not meet the order, and/or,
A process is not adhered to as laid down in the Quality, Safety, Environment, Human Resources or Administration Systems.
This is word for word from our training package. We tell them why we need to avert a NC and what a NC is. We then go on to explain how we can prevent a NC
How can we prevent Non -Conformance & Contamination?
Be Vigilant,
Follow, Review and Update Work Instructions,
Check Documentation for errors,
Husbandry – Clean as you go,
Identify Change (Process),
Training,
If in Doubt ASK!
Finally we tell them what the ramifications can be:
What are the Ramifications of a Non Conformance &/Or Contamination?
Increased Costs,
Disgruntled Customers,
Loss of Sales/Revenue,
Discipline,
Rework, Rehandle, Retest, and
Investigate (CAR Raised).
Sidney Vianna 24th October 2006, 09:50 PM This is obviously an attempt to create a loophole and limit the scope of nonconformities in the system, but you can NOT disregard the definition of nonconformity contained in ISO 9000:2000 or ISO 9000:2005. ISO 9000 is a NORMATIVE reference in ISO 9001. Thus, your organization can NOT define nonconformity in a way that violates what is supposed to be.
If you start that path, then you create your own definition of quality, corrective action, etc... a slippery slope with no end.
Greg B 24th October 2006, 11:14 PM This is obviously an attempt to create a loophole and limit the scope of nonconformities in the system, but you can NOT disregard the definition of nonconformity contained in ISO 9000:2000 or ISO 9000:2005. ISO 9000 is a NORMATIVE reference in ISO 9001. Thus, your organization can NOT define nonconformity in a way that violates what is supposed to be..
Sorry Sydney...but are you implying that I am creating a loophole in the system by defining what is a NC? The standard does not tell us what a NC is in 8.3 (9000:2000 or 9004:2000) but rather tells us how to control them, record them etc. I think everyone MUST decide what a NC is within their organization otherwise they cannot be reported correctly because each person may have a different opinion of what is or is not conforming.
If you start that path, then you create your own definition of quality, corrective action, etc... a slippery slope with no end. I think everyone MUST define these things themselves. Each company is different and the definitions in the standard are sometimes rather broad, bland and open to confusion (hence the need for this forum). I use the standard a s guide not as a defining document. Everyone knows I hate the standard, with a passion, but that is another issue. I still adopt it but I am not ruled by it.
Sidney Vianna 25th October 2006, 12:31 AM Sorry Sydney...but are you implying that I am creating a loophole in the system by defining what is a NC? The standard does not tell us what a NC is in 8.3 (9000:2000 or 9004:2000) but rather tells us how to control them, record them etc. I think everyone MUST decide what a NC is within their organization otherwise they cannot be reported correctly because each person may have a different opinion of what is or is not conforming.
I think everyone MUST define these things themselves. Each company is different and the definitions in the standard are sometimes rather broad, bland and open to confusion (hence the need for this forum). I use the standard a s guide not as a defining document. Everyone knows I hate the standard, with a passion, but that is another issue. I still adopt it but I am not ruled by it.Greg, my previous post was a response to the OP. I believe that this thread has been moved from the ISO 9001 forum to the definitions, acronyms...forum. When I responded, it was within the context of complying with ISO 9001. If you are invoking compliance with ISO 9001, the definitions contained in ISO 9000 SHALL be followed. Period. No playing games with definitions. If this question was not in the context of ISO 9001, then disregard my post.
PS. If this thread has been moved, whomever did it should have alerted to the fact.
Greg B 25th October 2006, 03:32 AM Greg, my previous post was a response to the OP. I believe that this thread has been moved from the ISO 9001 forum to the definitions, acronyms...forum. When I responded, it was within the context of complying with ISO 9001. If you are invoking compliance with ISO 9001, the definitions contained in ISO 9000 SHALL be followed. Period. No playing games with definitions. If this question was not in the context of ISO 9001, then disregard my post.
Sidney, My point is that the OP is trying to write a DEFINITION for their system...NOT espouse that laid down by the standard on how to CONTROL a Non-conformance. The standard is a guideline and any company that tried to follow it ‘literally’ would be kidding themselves because it doesn’t (and can’t) tell you what an Non-Conformance IS!! I really think you and I are talking about two very different things.:confused:
Coury Ferguson 25th October 2006, 05:57 AM My definition of nonconforming, in my opinion, is simple:
Any product or service that does not meet the applicable drawings, specifications, customer expectations, contract/purchasing documents, or regulated authorities is considered nonconforming, be it returned from the customer or found during any of the processes.
Claes Gefvenberg 25th October 2006, 07:03 AM Welcome to the Cove rdd007 :bigwave: in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station." So, acc. to the definition nothing can go wrong until the product reaches final inspection? That sounds rather wasteful: Not dealing with a problem until so late in the chain.
/Claes
chergh 25th October 2006, 07:14 AM the ISO audit is coming up next month. I've got to get your input on this item, because it's very important to us ...
Are you truly serious with this post??? From what you have written it's quite clear the only thing that is important to your management is the bit of paper on the wall. your remarks about things not being tagged unless an auditor is about also seems to indicate this.
The definition is terrible IMO and seems to have been defined in such a way to keep time spent on corrective actions to a minimum.
Non-conformances raised on internal process items are not a negative thing they can and should be seen as an opportunity to make needed improvements to a system.
5 minutes later...
This sort of statement also leads to rash judgement, as can be seen from my rant above, from reading your companies definition I jumped straight to the conclusion that I would not want to do business with your company as I believe it has have poor management and no real commitment to improvement or running a "real" QMS.
Dean Frederickson 25th October 2006, 08:41 AM I agree with Chergh, it sounds like this is a buisness that spends more time trying to cover up nonconformances than working at fixing the root cause problems, which imho creates more costs than savings.
rdd007 25th October 2006, 09:00 AM Cherg and all, thanks ... I was starting to doubt my sanity after a few knock down drag out battles about this.
It's an ISO system (which is why I posted there first) ... and to me, the ISO definition of nonconformity is clear ... parts that don't meet requirements. That's wherever they are in the system.
And, to me, it's fundamental to good business sense that we track and address nonconformances with corrective action tools wherever they occur ... and do it in a hands on, low cost, shop floor real kind of way ...
Anyways, I needed the support and encouragement to go after this again ...
Marc 25th October 2006, 09:02 AM Are you truly serious with this post??? From what you have written it's quite clear the only thing that is important to your management is the bit of paper on the wall.
I'm sure the thread starter is serious. We must remember that many people are faced with management directives that they do not agree with, nor can they personally change. There is also the possibility that the thread starter is not as familiar with 'quality assurance' definitions as many who visit here.
RCBeyette 25th October 2006, 09:02 AM Top management has told me that "in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station." There are a few boxes or racks of parts that are scrap or rework at the workstations, and those are just thrown out or reworked when the operator or supervisor gets to it. They aren't tagged, except when an auditor is around ...
Wow...I actually stared at this post and re-read goodness knows how many times before feeling calm enough to post. rdd007, first off, please understand that any seemingly harsh posts are not directed to you personally. I think that many of us are in shock at this definition and we sympathize with your situation. I doubt any of us would want to be in your shoes right now. :(
To be honest, I don't believe that this definition will hold much weight with an auditor. I think that you've internally met the requirements for 8.3, although perhaps the auditor could take the route of you providing evidence of concession for the internal customer (i.e., the final inspection station accepting all products from the earlier work station no matter if they have defects).
If the definition of your nonconforming product is accepted by the auditor, I see potential findings elsewhere....
8.4 Analysis of data "....shall provide information relating to...(c) characterisitics and trends of processes and products including opportunities for preventive action..." - Your organization is throwing away defective parts/products without knowing why or for what reason. You may get hit for not tracking the defects.
8.2.4 Monitoring and measuring the product "....verify that product requireemnts have been met.....carried out at appropriate stages of the product realizatio process in accordance with the planned arrangements (see 7.1)." - Of course, we don't know what your planned arrangements are. :cool: But if there is something "hinky" there, the auditor may find some links here for a finding.
For what it's worth, not every "nonconformance" is evaluated by my organization. We have developed a nonconformance guidelines matrix which shows the 'trigger points' for a nonconformance. Depending on which trigger is hit, this will also determine the level of corrective action taken.
If the boxes/parts aren't tagged except when an auditor is around, it does sound as if the "tagging process" isn't working for you. That's okay. Where does it say that tagging must be performed?
7.5.3 Identification and traceability simply requires you to identify the product status. Your boxes could count as this...for example, use visual management to indicate the status of the parts...all parts in red boxes are not to proceed to final inspection, or something to that effect. Of course, from a good business standpoint, you'll want to know why parts have defects. Ties back into 8.4.
Basically, no, I'm not comfortable with how your organization has defined nonconforming product within their processes and I feel that the level of action taken is at a superficial level. However, my comfort level and feelings (and those of the auditor), are not what determine if you receive a nonconformance.
The auditor may accept your organization's definition, but I predict that you'll receive a nonconformance further within the process on how defective products are treated.
chergh 25th October 2006, 09:16 AM I'm sure the thread starter is serious. We must remember that many people are faced with management directives that they do not agree with, nor can they personally change. There is also the possibility that the thread starter is not as familiar with 'quality assurance' definitions as many who visit here.
My first thought on reading the question was that it was a troll. Follow up post showed this clearly wasn't the case.
Sorry if my post was a little angry but I'm sure others got a bit worked up after reading the post as well.
To rdd007 good luck with getting your point across to your management team I think you are truly going to need it.
SteelMaiden 25th October 2006, 09:17 AM rdd,
welcome. your management is putting you in a bad position, but your instincts seem to be right on. As for things that might help you make your case, if you can get your management to understand how much money they are wasting by not taking the steps to eliminate problems where they occur they may be more likely to understand (and embrace) the intent of the standard. The earlier in the process you find, control, and perform corrective action, the cheaper it is. Not to mention the costs associated with lost business, loss of reputation, etc. from customer dissatisfaction when the product goes out the door. They may need to be reminded that you cannot inspect quality into your product. Good luck.
Claes Gefvenberg 25th October 2006, 09:32 AM I'm in a new job, and the ISO audit is coming up next month.I'll assume you're talking about ISO9001:2000? If so, I think you have the ammmunition you need in clause 8.3:
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application.
Records of the nature of nonconformities and anys ubsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
/Claes
RCBeyette 25th October 2006, 09:51 AM I'll assume you're talking about ISO9001:2000? If so, I think you have the ammmunition you need in clause 8.3:
That's my gut feeling, as well, Claes, but I'm trying to find the exact part where rdd's organization fails to meet a requirement. By capturing the nonconforming product at final inspection, they are "preventing unintended use or delivery." By addressing nonconforming product detected by the customer, they are "taking action to eliminate the detected nonconformity" (and the standard technically only requires an organization to meet at least one of the items in a-c). If records are retained, including concessions, they've met the requirements of 8.3 havent' they?
I'm not saying I like the defintion...and I'm certainly not comfortable with it...but if the auditor finds that their definition and process for 8.3 are okay, I believe the finding will be in an element that can be tied into the nonconforming products (8.4, 8.2.4, 7.5.3, etc.).
chergh 25th October 2006, 09:59 AM If you define non-conformances as non conforming parts then surely your internal audit system cannot conform to 8.2.2
Jim Wynne 25th October 2006, 10:15 AM Beyond the fact that there are obvious inspection status issues inherent in the subject "strategy," the actual question being asked is, "Can we design a 'system' solely for the purpose of fooling people?" While it may be possible to get away with it in the near term, the prevarications will inevitably start to proliferate to the point where managing the lies will be much more difficult than just doing the thing right to begin with.
There is a story, perhaps apocryphal, about a friend of W.C. Fields visiting him when he was on his deathbed. Surprised to find Fields in the uncharacteristic position of reading the Bible, he asked Fields what he was doing. "Looking for loopholes," Fields replied.
If you wait until the end, it's probably too late.
CarolX 25th October 2006, 10:17 AM I'm in a new job, and the ISO audit is coming up next month. I've got to get your input on this item, because it's very important to us ...
Top management has told me that "in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station." There are a few boxes or racks of parts that are scrap or rework at the workstations, and those are just thrown out or reworked when the operator or supervisor gets to it. They aren't tagged, except when an auditor is around ...
So, I created a poll to get your educated opinons :-) Tell me what you think.
Thanks.
Hi rdd007,
Congrats on your first posting. You have been registered here for a while but never posted :thanks: !
Your profile shows you work for a company of about 20 employees - is this still the case? Is this your initial registration audit or a surveliance audit? The situation you describe above could be an item for your continual improvement program.
Many companies get lax until audit time rolls around - then everything is tagged. Your goal might be to find a way to have them identified all the time, not just at audit time.
Try to use this as an oppotunity for improvement.
Claes Gefvenberg 25th October 2006, 10:30 AM I think sending a flawed product further up the manufacturing chain could be interpreted as unintended use. If nought else it is pure waste.
/Claes
Craig H. 25th October 2006, 10:37 AM Hi, rdd007
Although answers to your original question may still be debated, I have a question for you:
Why not try to quantify the costs involved in treating internal "bad parts" (or, nonconforming parts, more correctly) in the manner being used, compared to identifying and solving the underlying issues? Repeating the same mistakes over and over again COSTS MONEY!!!!
If you can quantify how much, that cost becomes a virtual 2x4, with which you can knock some sense into certain management types. If you don't, rest assured, your competitors will.
Just my opinion, of course.
Coury Ferguson 25th October 2006, 12:42 PM I'll assume you're talking about ISO9001:2000? If so, I think you have the ammmunition you need in clause 8.3:
/Claes[/LEFT]
I am in agreement there. 8.3 would be the guiding paragraph.
If you define non-conformances as non conforming parts then surely your internal audit system cannot conform to 8.2.2
I feel the 8.2.2 would not apply at this time. The definition of nonconforming is the topic, which reflects, in my opinion, maybe the system is still being developed and/or implemented.
Jim Wynne 25th October 2006, 12:56 PM I feel the 8.2.2 would not apply at this time. The definition of nonconforming is the topic, which reflects, in my opinion, maybe the system is still being developed and/or implemented.
Whether or not something conforms, or is in "conformity" isn't dependent upon the stage of implementation. Something either conforms or it doesn't. The point I think chergh was making is that "conformity" has a specific, normative definition in the standard, and 8.2.2 says,
The management responsible for the area being audited shall ensure that actions are taken...to eliminate detected nonconformities...
Redefining "nonconformance" (which is the same thing as "nonconformity") certainly raises rational questions regarding adherence to the clear intent of the standard in this regard.
Sidney Vianna 25th October 2006, 01:05 PM Redefining "nonconformance" (which is the same thing as "nonconformity") certainly raises rational questions regarding adherence to the clear intent of the standard in this regard.Amen brother.http://www.ugoplayer.com/forum/images/smilies/notworthy.gif
That is why I said that the ISO 9000 definition is normative.
3.6.2 - nonconformity
non-fulfilment of a requirement (3.1.2)
If people start to re-define basic concepts willy-nilly, then the whole idea of following a Standard is trounced.
Coury Ferguson 25th October 2006, 01:08 PM The point I think chergh was making is that "conformity" has a specific, normative definition in the standard, and 8.2.2 says
The management responsible for the area being audited shall ensure that actions are taken...to eliminate detected nonconformities...
I have underlined specific sentences or words to address:
If that is what the thought pattern was driving at, then I might agree. But, if nonconforming/nonconformities has not yet been defined, then how would this apply to a system in development/implementation stage?
I guess I have lost a connection here :bonk: :confused:
Howard Atkins 25th October 2006, 01:11 PM ISO 9000:2000 uses its typical around the gardens approach
3.6.2
nonconformity
non-fulfilment of a requirement (3.1.2)
3.1.2
requirement
need or expectation that is stated, generally implied or obligatory
NOTE 1 “Generally implied” means that it is custom or common practice for the organization (3.3.1), its customers (3.3.5) and other interested parties (3.3.7), that the need or expectation under consideration is implied.
NOTE 2 A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement.
NOTE 3 A specified requirement is one which is stated, for example, in a document (3.7.2).
NOTE 4 Requirements can be generated by different interested parties.
It can mean whatever you want it to mean
:topic:
Does this
2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.
mean that if you use the definitions from ISO 9000:2005 you are in fact wrong? or right?
Greg B 25th October 2006, 03:35 PM If that is what the thought pattern was driving at, then I might agree. But, if nonconforming/nonconformities has not yet been defined, then how would this apply to a system in development/implementation stage?
I guess I have lost a connection here :bonk: :confused:
This is what I was trying to get at in my previous two repsonses. The definition of NC must be defined by the COMPANY. It is all well for the standard to have a 'normative' reference but that does nothing for the guy on the shop floor or the QA inspector. Here is the simple answer:
Define a NC for your company
Define how you control NCs within the company in line with the Standard and your business requirements
The problem with your management must be addressed but we can't do that for you. I suggest you write up an acceptable 'Controlling NCs' paragraph/chapter in your Quality manual, take it to your next Management review meeting and try and convince them of the standards intenet and how it can HELP your business. See my previous post (http://elsmar.com/Forums/showpost.php?p=170104&postcount=2) on what we use for training our shop floor guys - even they can understand it
Colpart 26th October 2006, 05:40 AM I think it is worth considering why we raise NC's. Surely it is to identify where corrective action needs to be taken. Clause 8.3 is not a 'stand alone' clause, it is part of a wider issue.
If NC's are only identified with the finished product and/or if the customer spots them, we are missing opportunities to improve the system and drive out problems.
Coury Ferguson 26th October 2006, 05:51 AM I think it is worth considering why we raise NC's. Surely it is to identify where corrective action needs to be taken. Clause 8.3 is not a 'stand alone' clause, it is part of a wider issue.
I agree.
Paragraph 8.5.2 could also apply. But, I still stand on that the system is either still in developmental or implementation stage. Once the system has been developed, with all requirements in effect and the system is going through maturity, than the other applicable requirements, paragraphs 8.5.2, 8.2.2, 8.2.4, 8.3, 8.4, and 8.5.1 apply.
Jim Wynne 26th October 2006, 09:06 AM I think that maybe a few important points are being missed, and people are talking past each other here. While I agree with Greg that "the organization" has options with regard to how "NC" is defined, the options might be limited. Pesky little things like customer requirements and international standards might play a part in it, and while it's certainly true that if I run the company I can proclaim that henceforth black is white within the boundaries of my own little bailiwick, if the customer (or the standard) calls for white and I supply black, there's going to be a problem, and it's just the sort of problem that registrars should be on the lookout for.
But let's get back to the OP for a moment, because there's an important inconsistency in it that's been overlooked here thus far. Here's what rd007 says that his management wants to do:
in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station.
In essence this is saying, "We might identify parts as nonconforming at some point before final inspection or the point when they reach the customer, but we're not going to call them that so we don't have to do CA until they reach final inspection (or the customer)." So it's not really a question of how "nonconformance" is defined, because if parts weren't identified as nonconforming in production, we wouldn't be having this conversation now.
As for the rationale--not having to to do CA until the end--what possible difference does it make when CA is done? What is the likelihood that failure to act promptly will result in the ability to identify root causes being compromised?
Then there's this scary bit:
There are a few boxes or racks of parts that are scrap or rework at the workstations, and those are just thrown out or reworked when the operator or supervisor gets to it. They aren't tagged, except when an auditor is around ...
(Ellipsis in the original)
So now we know that not only are there parts which have been recognized as conforming, but they also might not be properly marked or otherwise identified as such (perhaps because the special definition of NC hasn't been applied yet).
So let's summarize: The company is aware that nonconforming parts are being produced, but doesn't want to deal with them on any level until final inspection or until they reach the customer. Management feels that this "strategy" can be justified vis a vis the ISO requirements by simply declaring that parts that have been identified as nonconforming are not actually called nonconforming until it might be too late.
Does any of this actually make sense to anyone?
RCBeyette 26th October 2006, 09:40 AM So let's summarize: The company is aware that nonconforming parts are being produced, but doesn't want to deal with them on any level until final inspection or until they reach the customer. Management feels that this "strategy" can be justified vis a vis the ISO requirements by simply declaring that parts that have been identified as nonconforming are not actually called nonconforming until it might be too late.
Does any of this actually make sense to anyone?
Does it make sense? No. But if this is how the organization has chosen to deal with nonconforming parts in an effort to prevent delivery to the customer, I think 8.3 is being met. It's those linked elements where the issues will start to crop up.
Jim Wynne 26th October 2006, 09:55 AM Does it make sense? No. But if this is how the organization has chosen to deal with nonconforming parts in an effort to prevent delivery to the customer, I think 8.3 is being met. It's those linked elements where the issues will start to crop up.
I think it's clear that "an effort to prevent delivery to the customer" has nothing to do with the strategy in question. It was clearly stated that the motive was to not call NC "NC" until final inspection or after bad parts reach the customer so as to delay or avoid doing CA.
Added in edit: This thread reminds me of the old story about the two guys who were eaten by a large amphibious reptile while arguing about whether it was an alligator or a crocodile.
Greg B 26th October 2006, 07:15 PM I am in agreement there. 8.3 would be the guiding paragraph.
I feel the 8.2.2 would not apply at this time. The definition of nonconforming is the topic, which reflects, in my opinion, maybe the system is still being developed and/or implemented.
Whether or not something conforms, or is in "conformity" isn't dependent upon the stage of implementation. Something either conforms or it doesn't. The point I think chergh was making is that "conformity" has a specific, normative definition in the standard, and 8.2.2 says,
Redefining "nonconformance" (which is the same thing as "nonconformity") certainly raises rational questions regarding adherence to the clear intent of the standard in this regard.
What does 8.2.2 have to do with Non Conformance as discussed by the OP? 8.2.2 addresses NCs found by the AUDITOR during INTERNAL AUDITS. I must ask why people keep using the word 'Normative Reference'. There is no explanation or definition of what a Non Conformance IS but their are guide lines on what we have to do with them - in the standard. This is like those massive discussions we have on 'Preventative vs Corrective' an endless circle of standard references, dictionary quotes and interpretation. the OP should explain better what he actually wants us to do. Is he just getting something off his chest? Does he want us to pass on similar experiences of Management brutality relating to QA systems or does he want us to offer a solution to his problem?
Sidney Vianna 26th October 2006, 07:24 PM I must ask why people keep using the word 'Normative Reference'. There is no explanation or definition of what a Non Conformance IS but their are guide lines on what we have to do with them - in the standard. I hope you will agree that ISO 9001 invokes ISO 9000 as a NORMATIVE REFERENCE. Because it does. If you agree that non conformance equates to nonconformity, then the definition of nonconformity in ISO 9000, and already posted, applies in the context of ISO 9001 implementation.
And to refer to ISO 9001 as a guideline is wrong. ISO 9001 contains requirements. The requirements contained therein require interpretations to be applied in the different contexts. But, unless the requirements can be excluded, due to the nature of the business, one can not pick and choose the requirements and still meaningfully declare compliant to the Standard.
Greg B 26th October 2006, 07:45 PM I hope you will agree that ISO 9001 invokes ISO 9000 as a NORMATIVE REFERENCE. Because it does. If you agree that non conformance equates to nonconformity, then the definition of nonconformity in ISO 9000, and already posted, applies in the context of ISO 9001 implementation.
And to refer to ISO 9001 as a guideline is wrong. ISO 9001 contains requirements. The requirements contained therein require interpretations to be applied in the different contexts. But, unless the requirements can be excluded, due to the nature of the business, one can not pick and choose the requirements and still meaningfully declare compliant to the Standard.
Sidney, my point is that the definition does still NOT tell you what a Non conformance is. The company and its customers MUST work that out themselves. I DO posses copies of the standard and this does nothing to help anyone IMO.
As stated in ISO 9000:2000
3.6.1: CONFORMITY: Fulfillment of a requirement (3.1.2)
3.6.2: NON CONFORMITY: Non fulfillment of a requirement (3.1.2)
3.1.2: REQUIREMENT: need or expectation that is stated, generally implied or obligated
This is like saying DEAD: Not living or ALIVE: Not Dead. My point in my original reply to this thread is that the company MUST define what an NC is to THEM. They MUST document WHAT their REQUIREMENTS ARE!!! Did anyone actually read my original reply or was it once again glossed over by the international dateline:mad:
The OP MUST define what a NC is otherwise it defeats the purpose of having a procedure on what do do with them AFTER they have been discovered - be it in process or at final inspection. If the operators do not know what their internal parameters (3.2.1 requirements) are then they CANNOT put the procedure for remedial action in place!
Sidney Vianna 26th October 2006, 08:13 PM The OP MUST define what a NC is otherwise it defeats the purpose of having a procedure on what do do with them AFTER they have been discoveredGreg, the OP questioned if the upper management definition of a NC as Top management has told me that "in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station." would fly.
You responded If that statement works for YOUR company then USE IT! but I personaly don't agree with it.I think many Covers and the poll results state that the suggested definition would not be accepted during an external audit, so most respondents, through their posts, tried to dissuade the OP from using it. So, the OP knows now that they have to find ANOTHER definition of NC. And, I hope whatever they come up with does not contradict "the non-fulfillment of a requirement" .
Greg B 26th October 2006, 08:51 PM Actually Sidney, THIS is what I posted first up. I told them their response was lame and offered ours as an EXAMPLE. These are OUR REQUIREMENTS for a NC and an explanation on why we have them!!
If that statement works for YOUR company then USE IT! but I personaly don't agree with it. This is the definition that I use:
NON CONFORMANCE
"To meet our customers’ needs and expectations, 'Our companys' products must conform to agreed requirements that include chemical, physical and sizing specifications, as well as packaging and delivery specifications."
A NON CONFORMANCE is caused when:
Product does not meet Specifications,
Product/Packaging/Delivery/Qty etc does not meet the order, and/or,
A process is not adhered to as laid down in the Quality, Safety, Environment, Human Resources or Administration Systems.
This is word for word from our training package. We tell them why we need to avert a NC and what a NC is. We then go on to explain how we can prevent a NC
How can we prevent Non -Conformance & Contamination?
Be Vigilant,
Follow, Review and Update Work Instructions,
Check Documentation for errors,
Husbandry – Clean as you go,
Identify Change (Process),
Training,
If in Doubt ASK!
Finally we tell them what the ramifications can be:
What are the Ramifications of a Non Conformance &/Or Contamination?
Increased Costs,
Disgruntled Customers,
Loss of Sales/Revenue,
Discipline,
Rework, Rehandle, Retest, and
Investigate (CAR Raised).
The Original Post DID NOT DEFINE what an Non-Conformance IS. It just stated what to do with them once they were found. How can you detect them if you first don't state what constitutes a NC. This has been my point from the beginning and I really think too many people defend the standard and what it may require first rather than give an alternative or understand what the actual issue is. In his statement from Top Management he never tells us that "a non conformance is non conforming parts...." what is a NC and what constityutes NC parts. This MUST be established for the statement to work.
Jim Wynne 26th October 2006, 09:11 PM The Original Post DID NOT DEFINE what an Non-Conformance IS. It just stated what to do with them once they were found. How can you detect them if you first don't state what constitutes a NC...This MUST be established for the statement to work.
Nowhere in any of this is there any suggestion that the OP's company was struggling with the definition of nonconformance. In fact the OP's management must have defined what it means, otherwise why would the question even be asked? Why would they be trying to weasel their way around the definition if they didn't know what the definition was?
Greg B 26th October 2006, 09:56 PM I'm in a new job, and the ISO audit is coming up next month. I've got to get your input on this item, because it's very important to us ...
Top management has told me that "in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station." There are a few boxes or racks of parts that are scrap or rework at the workstations, and those are just thrown out or reworked when the operator or supervisor gets to it. They aren't tagged, except when an auditor is around ...
So, I created a poll to get your educated opinons :-) Tell me what you think.
Thanks.
Nowhere in any of this is there any suggestion that the OP's company was struggling with the definition of nonconformance.
Jim (and others), The TITLE of the post is "How is this DEFINITION of NONCONFORMACE?" and his opening line is "Top management has told me that in our quality system we have defined nonconformances as..."
This is NOT a definition of a what constitutes a NC!!!! The company IS "struggling " to define what a Non Conformance IS!
In fact the OP's management must have defined what it means, otherwise why would the question even be asked? Why would they be trying to weasel their way around the definition if they didn't know what the definition was?
In 'FACT' This IS their 'definition' (as stated in the title) and I am saying it isn't good enough AS a definition. This is what they do AFTER they find a NC! They are not trying to 'weasel' around the definition. They are trying to 'weasel' around the fact that they have in process issues that they do not want to deal with until final inspection. if they want to do it this way then that is their prerogative but I was offering a solution to the term 'DEFINITION' not their procedure for dealing with NCs
Madfox 26th October 2006, 10:35 PM To quote Dorfman in "Animal House."
Unfortunately it seems the original posters company's main mission is to put lipstick on the pig a week or two prior to the 3rd party audit. IMNSHO, the discussion here regarding N/C product misses the "big pic."
I view a "N/C" as a failure to meet customer, again, customer requirements. I truly don't go to many places making bad stuff, the market place has put them out of business, or China has been able to meet/exceed the previous quality levels. I do go to a lot of places were on-time delivery is below 90%! ("Hey, you know how it is, we ship a gizillion pieces a day, you can't be perfect.")
As an auditor I'm asking for an orientation regarding the organization's "complaint system." What constitutes a "complaint" here. Not all complaints have to generate CA's, and not all CA's have to be acted upon. In my subconscious I'm thinking, "is management really hearing about issues the customers are bringing up." N/C should be something sales is involved in, or be aware of.
Greg B 27th October 2006, 12:47 AM To quote Dorfman in "Animal House."
IMNSHO, the discussion here regarding N/C product misses the "big pic."
We are not talking about the "big picture" we are talking about the OPs 'definition' of a Non-Conformance.
I view a "N/C" as a failure to meet customer, again, customer requirements. I truly don't go to many places making bad stuff, the market place has put them out of business, or China has been able to meet/exceed the previous quality levels. I do go to a lot of places were on-time delivery is below 90%! ("Hey, you know how it is, we ship a gizillion pieces a day, you can't be perfect.")
We are talking about the OPs requirement for a definition of an NC and IMO this is NOt soley based on customer 'opinions' unless the customer also includes up and downstream process owners (internal customers)
As an auditor I'm asking for an orientation regarding the organization's "complaint system." What constitutes a "complaint" here. Not all complaints have to generate CA's, and not all CA's have to be acted upon. In my subconscious I'm thinking, "is management really hearing about issues the customers are bringing up." N/C should be something sales is involved in, or be aware of. This is just off the mark totally. Management aren't hearing ANYTHING let alone their customers. Did you read what they wanted in the OPs post? Once again my reply was glossed over. Maybe I should only post in the daylight hours of the USA rather than midnight your time!:mad:
BradM 27th October 2006, 01:41 AM I would like to thank everyone involved. I learn so much reading the posts.
As far as the OP, my advice to him/her would be to not give the nonconformance statement another thought. If this came from top management, I am not going to ride in as the new guy and start telling them they are doing things wrong. Increased responsibility should come increased authority. If the OP is responsible for the success of the audit, then he/she should have the authority to change that definition themselves. Otherwise, I would ignore it.
Would your/ my top management change policy overnight, and based on what? If that nonconformity approach has already survived some time, audits, customers, etc., then there are probably other quality issues that the new person can tackle and win easier than changing top managements minds.
What is nonconformity to me? Here is my list, in order of priority:
1. What my customer defines as nonconformity
2. What my regulatory agency/ auditor defines as nonconformity
3. What top management defines as nonconformity
4. What I define as nonconformity
Hopefully, these four can get aligned fairly quickly, with the customer leading this activity. It may not be a direct lead, but as a by-product of say, end item rejection and potential loss of contract.
I don't know; maybe the above list reads like a cop-out. But just as I have to live/ work in a world with imperfections that I cannot fix, I offer up little things I can change, and try to work within the rest. I do passionately care, but I know my place.
:topic:
Something to consider: Given the excitement and effort expended in this thread, what would everyone thing of a poll on the interpretation of nonconformance? Maybe in our own little Cove World, we can learn from each other the different interpretations of that word, and the different ways it is used. Just a thought.
Coury Ferguson 27th October 2006, 05:18 AM :topic:
Something to consider: Given the excitement and effort expended in this thread, what would everyone thing of a poll on the interpretation of nonconformance? Maybe in our own little Cove World, we can learn from each other the different interpretations of that word, and the different ways it is used. Just a thought.
Brad, you are able to create a poll with a new thread. If you need some help let any of the moderators know. We are here to help.
This type of poll would be beneficial for the readers.
RCBeyette 27th October 2006, 08:40 AM I'm in a new job, and the ISO audit is coming up next month. I've got to get your input on this item, because it's very important to us ...
Why is it important to your organization?
Top management has told me that "in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station." There are a few boxes or racks of parts that are scrap or rework at the workstations, and those are just thrown out or reworked when the operator or supervisor gets to it. They aren't tagged, except when an auditor is around ...
Out of curiousity, why is this their definition? We've seen Covers talking about weasel-like antics, but perhaps, rdd007, you could help us by explaining how this defintion came to be the accepted one within your organization?
I have a strange feeling that the organization knows that nonconforming means the nonfulfillment of a requirement (i.e. bad product). But what are the requirements? Are we talking just physical nonconformities here? What about late deliveries? Customer complaints? How are concessions dealt with?
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