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ISO9001 - QS-9001 Information Exchange
The following document is provided as a service to those seeking
to achieve and/or maintain ISO and/or QS 9001 compliance.Please help by contributing your involvement to the collective effort.
War Stories Welcome!
NOTE: The following is a diatribe I downloaded somewhere - and I can't remember where. I for the most part agree with what is said, and wanted to include it - alas, I cannot remember where I got it. However, the author is Rob Kantner.
Also - On 960908 Another View was appended to the end of Mr. Kantner's diatribe.
Q: I'm having a problem with a manager's explanation of what he feels ISO 9001 really is. He says it's a "consistency standard". He claims your process could be well documented according to ISO 9001 standards BUT you could be producing inferior products. This doesn't make sense to me. Can you shed some light on this for me?
A: Your manager's assertion that ISO 9001 is merely a "consistency" standard that could still result in inferior products is a common rap, traceable to a statement made by a Motorola executive in a Fortune article a couple of years ago.
Let me set the stage for my answer with a couple of "real world" disclaimers.
First of all, it is entirely conceivable to have one subcontractor, registered to ISO 9001, producing a higher level of "defects" than a subcontractor that is not registered. However, the latter subcontractor is, with virtual certainty, operating in a way that meets most if not all of the requirements (just doing it better than the subcontractor who is actually registered).
After all, there is nothing magical, and there is no rocket science, about the ISO 9001 requirements. They are simply good common sense (I have called it "Business 101") and the best companies typically meet most, if not all, of the requirements without bothering to get registered (yet).
Second: it's certainly possible to implement, and obtain registration for, an ISO 9001 system that produces some level of "defective" products. In the real world, defects, nonconformities, etc. are a fact of life. People are human; no system is perfect; things are constantly changing, etc.
However, the "consistent defects" rap begs the question at several different levels. First of all, the Standard does not presume to define what level of defects is acceptable. ISO 9001 is intended to be a universal standard, applicable to virtually all organizational activities everywhere in the world. If 1% of a company's toothpicks are defective, how big a deal is that? If 1% of a company's aircraft engines are defective, what's the impact on the customer? What's more, mechanisms built into the requirements, and the registration system, promote improvement at several different levels.
So, if ISO 9001 does not specify quality attributes or acceptable level of defects, who does? Ultimately, the customer. Sometimes, they do it empirically, by requiring the supplier to maintain a certain standard of acceptability against defined quality attributes. Even if they don't, they always do it by inference, by "voting with their feet." If your competitor is providing a better level of service and lower level of defects / nonconformities, your customers will over time flock to that competitor and put you out of business.
That's the real world, as I see it, irrespective of anything ISO 9001 says. So how does ISO 9001 address this issue.
ISO 9001 addresses the issue by requiring the supplier to take customer requirements and expectations into account at all critical junctures of the transaction. It does this through the three clauses that relate to the supplier's relationship with the customer.
The first of these is Contract Review, which ensures that your customer's requirements at the order-taking level (and afterward) are clear, complete, and unambiguous, and that you have the capability of meeting those requirements.
The second is Design Control, which ensures that your customer's design requirements are clearly defined, understood, and consistently met throughout the design cycle and afterward.
The third is Servicing, which ensures that your customer's servicing requirements (post-sale) are consistently met.
Meeting all of the requirements in these three clauses requires close and consistent communication with your customer at all critical stages of the transaction. That is as far as the Standard goes. The Standard does not replace, nor pretend to replace, the economic realities of life in a competitive business environment:
If your customer specifies certain things, and you fail to provide those things, the customer will react in a way that has an adverse economic impact upon you.Your competitors are continuously improving. If you do not continuously improve, you will lose share and, ultimately, your business.
Then, ISO 9001 requires you to identify defects and nonconformities immediately and to take affirmative action to identify causes, implement solutions, and follow up on those solutions to ensure that they are effective. You must have evidence that you are doing this on an ongoing basis. If you are producing a consistent level of defects and nonconformities and taking no effective action to remove the causes of those defects, you cannot obtain (or maintain) registration. It's that simple.
At the end of the day, ISO 9001 is a very basic and fundamental benchmark system designed to put businesses, regardless of their marketplace or location, "on the same page." Through the audit and registration structure, it functions as a communications system, providing some level of confidence to customers (especially potential customers, who may know nothing about you) in the integrity of your quality practices and your ability to meet your customers' needs.
But ISO 9001 is just a starting point. A foundation. Good common sense.It does not take the place of customer requirements (and it states this very clearly). It makes sure that you take customer requirements into account on a disciplined, consistent basis, and incorporate these into your process as required to assure that customer requirements are met, both today and in the future.
Another View of The Consistency Rap Hi. I'm T.L., In-charge of quality systems activities at xxxx philippines, inc. I attended and passed a lead assessor course administered by international quality consultants ltd at kuala lumpur, malaysia in december 1991. I had also attended a 2-day qs9001 seminar at detroit in october 1995. On the side, i also do iso 9001 private consultancy for a medium-scale service-oriented company (not related to the xxxx business). Mpi had attained iso 9002 certification in febuary 1994.
I visited your web pages and have found them very helpful and interesting.
However, i would like to comment on the article you published regarding the "consistent defect" rap, authored by rob kantner. First, i must admit that, to a large extent, rob's article does have its merits. Especially the statement regarding iso 9001 as "just a starting point". This i believe should have been given more emphasis.
What bothers me in this article is what he continually refered to as the "real world" facts or scenarios. Defects and nonconformities was refered to as a "fact of life" as if we should be simply content with whatever level we had if it did not affect the customers. Such an attitude will definitely not result to continuous improvement.
I agree that there is no perfect system. But that should be no reason for not pursuing one. If human error or variability was the problem, then every effort should be given to eliminate or minimize it by automation, simplification or elimination, or by other means (I am presently working on one).
The idea is to establish an attitude of thinking differently across the company, thereby laying down the foundation for continuous improvement. This will not be achieved if complacency is allowed to prevail even if it means a 1% toothpick defect rate.
Now with regards to iso 9001 being a "fundamental benchmark system" fundamental, i agree. Benchmark, hardly. I think he must have not put in this word since benchmark refers to "best-in-class" systems, not fundamental ones.
One thing that rob failed to emphasize is that iso 9001 gives a lot of emphasis on documentation. In so doing, resources will have to be re-allocated, creating less for the more important activities affecting the bottomline results (productivity, product/service quality, delivery, operating costs, sales, profit, etc.). This is true moreso in small companies that do not have the luxury of computerization.
To me, the bottomline results is where most resources should be allocated - not on documentation for the sake of audits. Another problem lies in its application during audits. A number of iso 9001 auditors do not have much industry experience, creating a tendency of applying "bookish" interpretions of the standards. And because of the ongoing iso 9001 bandwagon syndrome, there has been a shortage of industry-experienced auditors. For what i have seen, inexperienced auditors normally conduct audits as if to prove to their auditees of their skills and knowledge of the standards. To do this, they need to find non-conformities. And since there is no such thing as a perfect system, they will attain this objective. That is, after constant digging. Each audit item then becomes an issue of pride which they need to justify, regardless of whether it will help the company satisfy its customers or not.
More non-conformities also entails more re-audits (or additional certification costs) - intended or not. Although it was not originally intended as such, iso 9001 has created its own industry, and compelled all other industries to avail of its services for profit.
Now that's the "real world" for you.
For most of rob's other observations in his article, i agree with 100%. From our experience, iso 9001 will not guarantee continuous improvement. At least not to the level that will allow companies to attain sustained growth.
It does not take a proactive stance in anticipating changing customer needs and expectations (beyond contract and design reviews, which are normally done before a project starts). Instead, it is limited to a reactive mode of responding to customer complaints (servicing). Statistics show that 9 out of 10 unsatisfied customers do not even bother to complain. They just leave at the first opportunity, and/or don't come back at all.
i hope you don't get me wrong. Despite all the things i mentioned above, i still believe that anything that is helpful, is good. Iso 9001 does make a distinct positive difference when implemented correctly. Especially for companies that do not have the basic quality systems framework. It will ensure that such systems are established, sustained and effective. If appropriately applied, it is even a very good foundation of conformance in which to build a system of continuous improvement.
However, it should be viewed as a "means" and not "the end objective". A trap which most companies fall into. This, as i understand it, was the basis for the "consistency standard" allegation.
Getting the certificate is only the beginning. A step in the right direction. A measurable world-class set of standards, such as the malcolm baldrige national quality award (mbnqa) criteria, needs to be pursued to be guaranteed of sustained growth. The mbnqa criteria gives equal importance or emphasis to the bottomline customer and business results which is the real basis for customer satisfaction. And customer satisfaction is the real intent of any quality systems standard.
Such realities, i believe should be made known to all who have attained, or intend to seek iso 9001 certification.
MABUHAY,
TL
TL:
I agree with the elements of your response. I pretty well see ISO 9001 as a benchmark in the sense that it, for many if not most companies, establishes a minimum for:
- Documentation (System, Procedural, Forms & Tags, numerous Records, etc.)
- Assignment of Responsibilities
- Tracking of, and Response to, Nonconformities
I see the Real World as one where even process noise changes with each season of each year. Last September's noise may not be, and probably isn't, the same as this September's noise. From this, I see an ever-changing set of conditions which must be dealt with. So I agree that there will always be defects. I do agree with you in saying that we should none-the-less never be content with a certain level of defects. Continuous Improvement also involves identification of, and reaction to, an ever changing (evolving) process. Process stability is not solely a function of controlable factors and the non-controlable factors themselves are a mutating group providing an ever-moving target. I don't see how anyone can reach a point where continuous improvement becomes a mute point.
I very much agree that a fundamental change in the way we look at things (which includes Attitude) is a basic feature of ISO/QS 9001. I tell folks that they may reach ISO or QS registration and pass - However, I estimate for most companies it will take about 2 years before the company is enculturalated.
I use the word Benchmark loosely, I suppose. To me it means a point where we draw a line in the sand and differentiate from past and future. Or the point at which one sets a minimum from which to proceed. I looked up Benchmark in my Webster's dictionary. It did not mention Best-In-Class and I admit I do not think of a bench mark (or benchmark) as Best-In-Class. In fact, I believe that the definition of Best-In-Class is a Limited Business Origin Definition unrelated to the (a) dictionary definition.
I do not see documentation as a limiting factor taken in the light of what is intended - to standardize system and process methodologies. I could speak volumes on documentation, including Tailoring and As Appropriate. The bottom line on documentation, most people, including the new class of Nouveaux Auditors, do not understand it. Small companies are not generally penalized. In the 20th (soon to be 21st) century, this should not be a problem. I do agree that in larger companies (maybe 500+ employees) a new position may be a neccessity for control. In the evolution from labour based to intelligence based 'production', this is not surprising. I believe relating documentation to resource allocation misses the point of having documentation. Nor is documentation there for the sake of the auditor(s).
I fully agree that there are few good auditors. My work revolves around helping companies deal with auditors. Interpretations, etc. And I don't doubt that many, many auditors are in it for both the money and as a power trip. I believe any company's best defense is to have someone in-house who is an 'expert' in ISO/QS 9001. That 'expert' should do what I am doing - defend the company by understanding the specs and being able to explain how the company meets 'Intent'. The external auditors are not there to help a company satisfy customers - They are there to validate systems including associated documentation.
Yes - ISO/QS has created an industry - I'm part of it. For Good or for Bad... Yes - This is the 'Real World'.
No - neither ISO nor QS address sustained growth - but then I don't believe there is a specific formula for that. A big part of that is supposed to be why CEOs and their ilk take home around 133 times the average hourly worker's salary. I do not believe there is ANY magical formula or specification (or anything else) to ensure sustained growth. I see ISO 9001 as the minimum on which to base a business, not as an all encompassing cure-all for business. Maybe we sometimes want more from a specification than it is intended to provide.
This page last reviewed or edited: Sun, 2007-02-04 16:53 (Coordinated Universal Time [ZULU] -5 hours)
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