ISO 9001 - Meeting the INTENT vs. Meeting the REQUIREMENT

[Marc]

From: ISO Standards Discussion
Date: Tue, 25 Jul 2000 09:41:01 -0500
Subject: Re: Intent vs requirement /Marshall/Hankwitz

> This is just an observation, and was wondering why......
>
> Many times while reading some of the email on this list,
> I see things like ".... meeting the intent of 4.8,..." etc.,
> instead of.... meeting the requirement of 4.8.... (snip)
> Why are folks using the word intent and not requirement?

Art,

I would guess because the "requirement" is words, and "intent" is what's behind the words. All too often, users read and use the words without having a clue as to what the words are saying, or think they say something that just isn't true.

As an example, ISO 9001:1994 4.1.2.1 Responsibility and authority states, "The responsibility, authority, and the interrelation of personnel who manage, perform, and verify work affecting quality shall be defined and documented..." You have no idea how many people insist that this mandates the creation of an Organizational Chart.

I often see the same thing when people reference Deming's 14 points. They rattle off a point as a example to help make their point, and it's obvious they haven't a clue about the point being made. It's clear they never took the time to read the book and are therefore operating on misguided assumption.

John

------------------------

From: ISO Standards Discussion
Date: Tue, 25 Jul 2000 09:43:29 -0500
Subject: Re: Intent vs requirement /Marshall/Arbuckle

Art brings up a good question, and since I have probably used both words as much as anybody else, I suppose I ought to explain my "intent."

The standard defines requirements, which are things that must be done. It does not define "how" to do them; (thank heavens!) that is left up to the organization to figure out. In many cases, the requirements can be met in a number of ways, depending on the outcome that best serves the organization. That is the "intent" of the requirement.

When I refer to "intent" I am speaking in terms of what is best for the business in meeting the requirement itself. I accept that "intent" is always up for interpretation by others and believe that one organization's reading of "intent" may be different from another's. That is what makes the world go round. I believe the standard gives us the right to "interpret" the requirements in the Introduction itself, "The design and implementation of a quality system will be influenced by the varying needs of an organization, its particular objectives, the products and services supplied and the processes and specific practices employed." Just like everything else, then, "Reality is nothing more than the perception of the masses." Substitute "Intent" for Reality.

Donald

----------------------

From: ISO Standards Discussion
Date: Tue, 25 Jul 2000 09:45:25 -0500
Subject: Re: Intent vs requirement /Marshall/Humphries

Art,

The history of ISO9000 is from a very specific industry: defence engineering contracting. If one simply applies the strict requirements (or even worse, the normal interpretations from that industry) to other industries, one ends up a bureaucratic nightmare, irrelevant to the organisation or to the needs of its customers - hence not conforming to ISO9000!

Therefore, one has to use a little wisdom and insight to understand what ISO9000 is trying to achieve, and work out how, in a normal "other" industry environment, one is going to achieve the same ends.

This is improved in the Y2K DIS, but not completely eliminated.

Best Regards
Edwin

--------------------

From: ISO Standards Discussion
Date: Tue, 25 Jul 2000 09:49:47 -0500
Subject: Re: Intent vs requirement /Marshall/Kozenko

Art inquired:
"Why are folks using the word intent and not requirement?"

Everywhere I've seen "intent" used in a post, it's been to explain this nuance: that the strict interpretation and application of a stated requirement just does not make good business sense.

David

[Marc]

From: ISO Standards Discussion
Date: Tue, 25 Jul 2000 13:21:03 -0500
Subject: Re: Intent vs requirement /Marshall/Arbuckle/Scott

Don concluded with...
Just like everything else, then, "Reality is nothing more than the perception of the masses."

Art,

While I certainly wouldn't leap to Don's conclusion, what is "intended" by a "requirement" does depend on many things, not the least of which are the perceptions (grids, biases) of the one(s) attempting the translation. Hopefully, and I think generally, there is sufficient range in the areas of agreement among those implementing a system and those auditing the system that a useful standardization process results.

Count me among those whose perception is that one gets good return on the investment when one straightforwardly approaches the requirements of a standard, implements them in a way that demonstrably makes good business sense, and fanatically avoids resorting to elaborately constructed illusions to pass an audit.

Regards,
Phil

----------------------------------

From: ISO Standards Discussion
Date: Tue, 25 Jul 2000 13:35:40 -0500
Subject: Re: Intent vs requirement /Marshall/Scalies

From: "Charley Scalies"

Art,

That's a fair question. Assuming for a moment that there is a difference,
given the choice what would folks rather do? Meet the intent of the standard
or the requirement? I'll bet the answer will differ depending upon whether
"Job 1" is Registration or Quality.

What is the intent of 4.8? Making sure that, at all times, you know what it is you are working on so that you can match it to its requirements. Does ISO really care how you do that?

What is the intent of 4.5? To have a "master list or equivalent" or to be certain that the right documents are right there, where and when they are needed, and that they are used.

What is the intent of 4.3? To review contracts and complete Contract Review forms or to be certain you and your customer have a meeting of the minds and that you have the ability to do what you agree to do?

Have you ever seen someone deliver an ISO9000 orientation where all they do is recite the "requirements?

4.1 says, ..... 4.2 says, .... By 4.7, everyone in the room is catatonic. On the other hand, a highly effective orientation can be done using only a single graphic as the tool to describe what an ISO9000 quality system is really all about. I do it all the time. I think I leave my audience better informed: I know I leave them breathing.

ISO9000 is not 18, 19 or 20 requirements. It's about 1 thing. A quality system. It's a forest, not a collection of trees. The trees are important, but getting too hung up in the "requirements" without being fully cognizant of their intent and how they all fit together results in, as the hackneyed saying goes, not being able to see the forest thru the trees.

Finally (at last!) if you were given just 30 minutes in which to conduct an audit of the effectiveness of a quality system, would you try to audit all 18...20 elements (requirements) or would you go straightaway to verifying whether or not the quality policy was being fulfilled (intent)?

Charley

[Marc]

From: ISO Standards Discussion
Date: Tue, 25 Jul 2000 13:56:54 -0500
Subject: Re: Intent vs requirement /../Kozenko/Hartman

David M. Kozenko stated, "Everywhere I've seen "intent" used in a post, it's been to explain this nuance: that the strict interpretation and application of a stated requirement just does not make good business sense."

Perhaps showing my age a bit: Exactamundo! Or as the Quality Director at one of my former employer's would say "Meet the requirement, but don't do anything stupid."

The idea is to implement a quality program that meets the requirements, but does so in a fashion that does not hinder, but benefits the company. I have been responsible for the creation and implementation of ISO 9001 and 9002 programs at 8 small to large companies in the past 8 years and have never seen an instance where I could boiler-plate the entire program (perhaps portions, but never entire programs). To develop a single way of meeting the requirements and forcing it on every facility or company would be too cost prohibitive, or would not be implemented properly/consistently, since in many case entire cultures would have to change.

Maybe I'm too naive, but I enter most successful companies with the thought that the way they are doing business more than likely meets the "intent" of the ISO requirements, one just has to interpret (and document) what they are doing in such a fashion that it clearly addresses the ISO requirements. I realize that 8 companies is not a large population (perhaps not even a significant population), but so far I haven't been wrong.

BTW: If you didn't catch it, the significant words in my theory are "successful companies". Companies that aren't successful might even benefit by performing a realistic gap analysis against the requirements (not that a quality program is the cure all for company ills, but in many cases it wouldn't hurt).

David

[Marc]

From: ISO Standards Discussion
Date: Wed, 26 Jul 2000 09:17:41 -0500
Subject: Re: Intent vs requirement /Marshall/Pfrang

From: "Pfrang, Doug"

"Intent" is often invoked when someone doesn't want to comply with a particular requirement of the ISO Standard and can't figure how else to avoid it, or, what is more pernicious, when someone wants to impose a requirement that isn't in the Standard at all. Because it is entirely subjective, the "intent" of the Standard can be anything someone wants it to be, which is precisely why all arguments based on "intent" are unreliable. This is especially true when dealing with someone who was not part of the ISO Standards committee, because such a person has no trustworthy knowledge of what the "intent" is anyway. What matters is what the Standard _objectively_ requires, and the only source for that information is the Standard's actual wording.

-- Doug

[Marc]

From: ISO Standards Discussion
Date: Thu, 27 Jul 2000 11:15:52 -0500
Subject: Re: Intent vs requirement /../Pfrang/Andrews

Doug wrote (in part);
"What matters is what the Standard _objectively_ requires, and the only source for that information is the Standard's actual wording."

All right - I tried to stay out of this discussion; however, I feel the need to relay a little story (true) that I keep in mind to illustrate "intent" vs. actual wording.

Several years ago a client of mine was undergoing an ISO 9001 audit by a representative of a well known registrar. We were in the 'Quality Records' phase of the audit. The auditor, with copy of Standard in hand and reading word for word 4.16, wanted to see where in their procedures they had defined the "identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records.". The client confidently showed where in each applicable procedure they had identified how the quality records were identified, how (by date/alphabetically/numerically, etc.) and where they were filed, who had access, for how long (minimum) they were filed and how they were to be disposed of.

The registrar auditor, peering over his glasses, asked where in each of the procedures the client had addressed the "indexing" of the records. The client patiently pointed to the part of each procedure that explained how the records were filed (by date, etc.). The auditor, now getting a bit impatient, stated that what the client had described was the 'filing' part of the requirement (as the client had even called it 'filing' in the procedures). the auditor wanted to see where the 'indexing' part of the requirement had been specifically defined.

At this point in the, obvious disintegration, of the audit process, I intervened. I had a mini-conference with the auditor and it is at this point where I used "intent" vs. "word for word" interpretations of the Standard. It is obvious, to most anyway, that the "intent" of 4.16 of ISO 9001 is for a company to have a defined system in place that describes how quality records are identified, how they are stored, who can get to them, how long they are to be kept, and how they are disposed of so that those who need the information, be they internal people or external auditors/customers, can get their hands on it. Period.

Anyway - it has been so long that I forget what the final outcome to this story was (agreement or finding?); however, the story has stuck in my mind as a good example of how individuals can get lost in the "wording" of the Standard and lose sight of the "intent".

Sorry to be long winded on this one - but I thought it might be a story worth telling for this topic.

Ethan
-----------------------------------

From: ISO Standards Discussion
Date: Thu, 27 Jul 2000 11:19:34 -0500
Subject: Re: Intent vs requirement /../Pfrang/Humphries

Doug,

In the words of the immortal bard: I disagree with what you say, but will defend to the death your right to tell such LIES! :-)

Actually, I agree with some of it: "intent" IS often used in the ways you describe. However, I believe that a literal interpretation of ISO9001 will get you into trouble more often than not, UNLESS you try and understand what the writers intended by the requirement.

So often, the Standard refers to "where applicable", "where relevant" and "where appropriate"; all too often, the simplistic interpretation is that it must always be applicable, relevant and appropriate. Examples:

1. "A master list or equivalent document-control procedure identifying the current revision status of documents shall be established and be readily available to preclude the use of invalid and/or obsolete documents." Here, the "master list or equivalent document-control procedure" are merely examples; the intent is that the use of "invalid and/or obsolete documents" is "precluded".

2. "Purchasing documents shall contain data clearly describing the product ordered, including where applicable: a) the type, class, grade, or other precise identification; b) the title or other positive identification, and applicable issues of specifications, (etc.); c) the title, number, and issue of the quality-system standard to be applied." All too frequently, this translates in practice to a requirement to provide such information on orders whether relevant or no, and to rule any orders lacking any of the information as non-conforming. The INTENT is to ensure that the goods are sufficiently well described that the supplier can be in no doubt as to the identity of the goods required; frequently that can and should be done without most, sometimes all, of the information specified.

3. How many companies have procedures for Customer-supplied goods or for Statistical techniques that are not used, simply because someone insisted that these elements must be dealt with in some form, that the "where relevant" clauses still apply to everyone. The INTENT here is obviously to ensure that such activities, IF CARRIED OUT, are under appropriate control, and not to insist that every company uses them.

My point is that the concept of "intent" plays an essential role in the development of an effective (and fully compliant) quality system. Systems should not be developed by people with no practical experience of business or the industry in which they are operating, and they should be implemented with minimum impact and building on existing systems, rather than replacing them. You simply can't do this without considering or attempting to understand the "intent" of each clause.

Best Regards
Edwin

[Marc]

From: ISO Standards Discussion
Date: Thu, 27 Jul 2000 12:03:17 -0500
Subject: Re: Intent vs. requirement /../Staples/Arbuckle

The auditor was wrong and you were right to not accept it as a nonconformance. I also question the value of it as an observation, but at least you were able to get back to the audit. (I would question the value of the audit itself, given how odd the auditor appears!)

I would also agree with you that the word "intent" should be left out of the audit, unless the intent is defined (verbally by someone in a position of authority) or in a document. Then it is appropriate to verify the intent and effectiveness of the process to ensure intent is met.

Oh, one other word that has no place in and audit, especially from the auditor's mouth..."should." I cannot think of any reason why an auditor would use that word.

Donald

[Marc]

From: ISO Standards Discussion
Date: Fri, 28 Jul 2000 10:34:19 -0500
Subject: Re: Intent vs requirement /../Pfrang/Andrews/Kozenko

In the ISO9001:1994 Standard you will find the word "Indexing" in only a few places.

Ethan's post (quoted below) is a perfect example of what sometimes happens in the real world, when everyone wants to do what makes good business sense, but not so many people know that "Indexing" is a librarian's term that contemplates some sort of relational databasing, be it manual or fully computerized, or some mix 'tween the two.

In this example, I have to give the credit to the 3rd Party Auditor, who realized that the "intent" of the meaning of "Indexing" just blew right over everyone's head, and let it go.

Ethan, if you did "Index" to suit the intent, in your example, then I missed it and I apologize.

David
------------------------------------

Doug wrote (in part);
"What matters is what the Standard _objectively_ requires, and the only source for that information is the Standard's actual wording."

All right - I tried to stay out of this discussion; however, I feel the need to relay a little story (true) that I keep in mind to illustrate "intent" vs. actual wording.

Several years ago a client of mine was undergoing an ISO 9001 audit by a representative of a well known registrar. We were in the 'Quality Records' phase of the audit. The auditor, with copy of Standard in hand and reading word for word 4.16, wanted to see where in their procedures they had defined the "identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records.". The client confidently showed where in each applicable procedure they had identified how the quality records were identified, how (by date/alphabetically/numerically, etc.) and where they were filed, who had access, for how long (minimum) they were filed and how they were to be disposed of.

The registrar auditor, peering over his glasses, asked where in each of the procedures the client had addressed the "indexing" of the records. The client patiently pointed to the part of each procedure that explained how the records were filed (by date, etc.). The auditor, now getting a bit impatient, stated that what the client had described was the 'filing' part of the requirement (as the client had even called it 'filing' in the procedures). the auditor wanted to see where the 'indexing' part of the requirement had been specifically defined.

At this point in the, obvious disintegration, of the audit process, I intervened. I had a mini-conference with the auditor and it is at this point where I used "intent" vs. "word for word" interpretations of the Standard. It is obvious, to most anyway, that the "intent" of 4.16 of ISO 9001 is for a company to have a defined system in place that describes how quality records are identified, how they are stored, who can get to them, how long they are to be kept, and how they are disposed of so that those who need the information, be they internal people or external auditors/customers, can get their hands on it. Period.

Anyway - it has been so long that I forget what the final outcome to this story was (agreement or finding?); however, the story has stuck in my mind as a good example of how individuals can get lost in the "wording" of the Standard and lose sight of the "intent".

Sorry to be long winded on this one - but I thought it might be a story worth telling for this topic.

---------------------------

From: ISO Standards Discussion
Date: Fri, 28 Jul 2000 10:40:38 -0500
Subject: Re: Intent vs requirement /../Humphries/Kozenko

> Humphries stated:
> Systems should not be developed by people with no practical experience of business
> or the industry in which they are operating, and they should be
> implemented with minimum impact and building on existing systems, rather
> than replacing them. You simply can't do this without considering or
> attempting to understand the "intent" of each clause.

I agree with every part of Edwin's post except the portion quoted above, and only for this reason:

As a (take your pick ---> ) consultant's, quality manager's, ISO-Guru's medically measurable intelligence quotient increases, his/her ability to transcend the "industry specific" limitations in applying ISO9000 is correspondingly greater.

I have applied ISO9000 to several medical practices, and the only business or industry experience I have there is (albeit as a patient) professionally limited. But something magical happened when I kicked the quality butt of a doctor or two ;o) and I may never get the "cross pollination" award for ISO9000 application, but I'm confident in saying I might have saved a life or two for what little I've done there to the big picture.

To Edwin's credit, I must say that I did figure out how to blend what I knew about "systems" with that which was already in place.

Nothing personal Edwin. I will consistently slam anyone who even suggests that cross-pollination of ISO9000 precepts should not be attempted, much less, won't be successful.

Just an IMHO, 7 cents, 2 cents, take your pick

David
-------------------------------

From: ISO Standards Discussion
Date: Fri, 28 Jul 2000 10:43:49 -0500
Subject: Re: Intent vs. requirement /../Arbuckle/Kozenko

> Arbuckle writes:
> I would also agree with you that the word "intent" should be left out of the
> audit, unless the intent is defined (verbally by someone in a position of
> authority) or in a document. Then it is appropriate to verify the intent
> and effectiveness of the process to ensure intent is met.

If this thread was a high school dance, then I'd be the D.J. interrupting right now with this announcement:

If you are a firm's Quality Rep. or Quality Manager or similar position of import, and also, in the event you feel there is a question that could reasonably arise regarding your firm's application of ISO9000, where that application is conditioned upon your firm's interpretation of INTENT, then...

By all means, please specify it in your higher level quality documentation, be it Quality Manual, Senior Management Quality Directives, or even Quality Policy, but whatever it is, make it an integral part of your quality system documentation, what your firm's interpretation of the "intent" is, ok?

What will matter most, when the 3rd party auditor has sharpened pencil in hand, is whether or not you have satisfied the requirement of the 1994 Standard: "... and can be demonstrated."

You can blither and blather all you want internally about what the "intent" of a requirement is, but when the 3rd party auditor gets there, all that matters is (1) what you say that matters [which is, in fact, your own interpretation of what "intent" means in your firm's particular circumstances], and (2) any available "prove it" documentation your firm may have to show that it is meeting the "intent" requirements of (1) above.

(In the event I have not sufficiently beaten this "intent" horse to death, please issue clarification inquiries and I will dispatch a flogger of sufficient and appropriate length ;o)

David

[Roger Eastin]

Wow, this is a great post!! All the wrangling back and forth over "intent" and "requirement" has cleared these concepts up like a slab of thick mud. I understand what is meant by "intent", but how do you audit to intent unless it is defined somewhere? I hate to get too tongue-tied on this one, but I can't audit to something "behind the words"! This is difficult, because I sympathize with those who argue for intent - principally, because Intent = common sense! But even common sense sometimes can mean one thing to a person and something else to another person. So where does this leave us....