Is ISO 9001 Cresting? Is a rebellion in the works?

[Randy]

On topic: The company I am employed for has been open since 1993. We only have 1 customer out of 50+ that require us to be ISO. So in my place of employment, ISO has always just seemed like a pain. It is always just for that ONE customer(which isn't great anyways).

Nothing like an undead thread, eh?





Toyota and "approach to quality" don't belong in the same sentence anymore. Recalling over 5.3 million vehicles.....sounds like that "real good" kind of quality.

So identifying customer requirements/needs and achieving customer satisfaction in a controlled systematic fashion is of no benefit? If your QMS based system has be a pain as you call it then your time has been wasted because y'all never got the message and nver really employed it.

As for Toyota...perfect example of a QMS working staring with customer communication, corrective action, product design (or re-design), monitoring of process and product, all of it once the problems were solidly identified.

You mean to say that you guys have never had non-conforming product or a disatisfied customer? Fantastic, please share how that happened if it's true.

 

[rfjuice]

Sorry for your take on my "pain". It just seems for 1 customer that ISO is a bit much. Before that customer, everything was still dealt with swiftly.

A customer return>>figure out whats wrong>>fix it>>resend to customer.

During the process of figuring out what was wrong, it was determined if any changes needed to be done to the production process. Now since we are ISO, we have got all sorts of paperwork to fill out.(NCR's, CAPA, root cause's)
I know I haven't mentioned this before, but our company only employs a handful of people and when you take a few people away from production to work on paperwork, it can drastically cut production.

With Toyota, my reference to their quality, comes from reports that testing data went missing and that they would have showed that the cars/trucks had problems and they were delivered regardless. If their Quality System is as good as people say, shouldn't have document control kept these records a bit safer?

Unless of course they were "hiding" the documents. = D

 

[AndyN]

Now since we are ISO, we have got all sorts of paperwork to fill out.(NCR's, CAPA, root cause's)
I know I haven't mentioned this before, but our company only employs a handful of people and when you take a few people away from production to work on paperwork, it can drastically cut production.

Then I'd suggest that it's absolutely nothing to do with 'ISO' but whomever designed such a burdensome system...plus, your internal auditors, your MR and your management! If it's so apparent, why hasn't something been done about it?:mg::mg::mg:

And, btw, what on earth is your CB auditor looking at? (when you say 'ISO' you mean you're certified, right?)

 

[JaneB]

A customer return>>figure out whats wrong>>fix it>>resend to customer.

Yeah, that'll fix the immediate problem. Won't fix the problem of course, which could easily happen again.

During the process of figuring out what was wrong, it was determined if any changes needed to be done to the production process. Now since we are ISO, we have got all sorts of paperwork to fill out.(NCR's, CAPA, root cause's)

If you mean, we weren't doing anything 'on paper' at all before, we were all just flying by the seat of our pants and operating off memory and what our people 'knew', then I have no sympathy. That can be OK in a very tiny company, but it isn't a system, it's just a bunch of essential people. The wheels will fall off sooner or later.

But if you're complaining about a burdensome system, that's a pain to use, that has nothing - absolutely nothing!! - to do with ISO 9001 (IF that's what you mean by 'are ISO).

That problem is yours - made by you, your organisation. The cause of that problem lies fully at the feet of whoever designed your system in that particular way, who made it full of paperwork to be done, who designed it so that it takes 'several' people away from production etc. All yours.

If it doesn't work - fix it!!

 

[rfjuice]

Jane

I think we would fall into the "tiny" category.

-9 people on First shift
-5 of these have other responsibilities(shipping/receiving; QC; Customer Service; Supervison)
-3 people on Second shift
-2 of these have other responsibilities(Calibration; Auditing; Maintenance; Supervison)

So we have a total of 5 full time production people. I consider this tiny. Also due to a large variety of products and limited workspace, not much is automated.

I don't know maybe I came here looking for something I already knew....Our top management(who are 200 miles away) are a bunch of ^&%&^%&^%&^%&^%&^%&^%&^%&^%&^%'ers( use lots of nasty words <( ;..; )> ). They simply ignore our requests/suggestions/proof of optimal solutions to problems and say thank you. Then just never speak of it again.

I can't say that I have ever met our CB. I'm one of the few on second shift, so I don't get all the fun.


Randy-
I know we have the occasional bad product that is our fault, but in my 8 years here, I can safely say its below 1%. Everything is 100% tested as finished product before it leaves our facility. Products returned normally have a root cause of "customer error".

Example: Plugging a battery pack into a charger incorrectly. Even with a specially shaped plug and directions shipped with both Battery Pack and Charger, they managed to jam that thing in wrong.

To reproduce this effect we had to hit the battery pack plug with a hammer(charger was in a vice). We get several of these back a year.(we produce 10,000+) it would be kind of interesting to see how they did this. We never get an answer. : (

Edit: My grammar fails me.

 

[JaneB]

I think we would fall into the "tiny" category.

Yes, that's small. And yes, of course people have other responsibilities. Again, that's normal in small business. And I doubt any organisation could afford/justify a full time systems person until they were at least 8 to 10 times that size or more. I prefer though having the responsiblities distributed, rather than vested in one person.

But it's still more than possible to have very skinny and highly functional ISO 9001-compliant systems in small businesses. I've done it, and more than a couple of times. Not saying that to boast, simply statement of fact. It can be done. And in a small business, it's very important to have it skinny. Otherwise, as you have found, it's a pain in the rear. Actually, I prefer ALL systems to be as skinny as possible, larger organisations too.

But please don't lay blame where it doesn't belong. That pain you're feeling is not, not, not the fault of 'ISO' (they just produce the Standards), nor is it the fault of ISO 9001 (a specific standard). At all.

Indeed, the Standard itself has some relevant things to say, including in 0.1 (my bold added):

The design and implementation of an organization's quality management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

Alas, too many people either don't read that or don't understand it.

The problem lies elsewhere, as you've said:

Our top management(who are 200 miles away) are a bunch of ^&%&^%&^%&^%&^%&^%&^%&^%&^%&^%'ers( use lots of nasty words <( ;..; )> ). They simply ignore our requests/suggestions/proof of optimal solutions to problems and say thank you. Then just never speak of it again.

I'm sorry to hear this. They are failing in their responsibility. Perhaps they're doing the 'letter of the Standard' but they're certainly failing to harness its true power and do it in a way that's productive for the whole organisation, including one of its basic principles: involving people.

Again, I'm sorry to hear that and I feel for you. But it would be much more accurate to vent your frustration on the way that ISO 9001 has been done in your business and not on ISO 9001 or ISO.

 

[rfjuice]

Yes, I fully understand this. I also appreciate your points. They have been iterated to management quite a few times. I also can concur that my "pain" with ISO is the way its been implemented.

 

[statdoug]

Re: Good Question

I think we may be starting to see a return to more interest in real quality. It looks like everyone here recognizes the truth in Marc's statement that the wave has crested. Like all of these "waves," There are initial successes that breed a lot of interest. The Fad grows, and becomes self-consuming. The initial concept is lost, in the case of ISO, in a growing concern about dotting the "I"s and crossing the "t"s, and the initial concept that was designed to help get systematic improvement built in to business has been lost in a myriad of corrective actions on corrective actions on audits on procedures on how to audit the auditors who audit the internal procedures that describe how to respond to a corrective action request.
I was an early champion of development of systems for continuous improvement, but it has become focused on continuous improvement of the system to build systems. I say it's time to dump the mess and re-focus on real improvement efforts. It seems like the early horror stories that Deming cited; changing spec.s to "achieve" six sigma "excellence" (as I remember he talked about airlines) because improving processes takes time and hands-on work, are becoming more and more common.

It is great when you can show a dramatic drop in defect levels without any real interference with production. Toyota fell in to the spell that everyone else was weaving, but I think they have awakened, and I think others are and will too.

 

[JaneB]

Re: Good Question

It looks like everyone here recognizes the truth in Marc's statement that the wave has crested.

In the USA perhaps. Not necessarily throughout the entire world though.

 

[AndyN]

Re: Good Question

In the USA perhaps. Not necessarily throughout the entire world though.

Happily, it's not the case here in the USA. From my perspective, we're seeing strong growth in certification. Lots of organizations have dodged the bullet and, for many reasons, have now decided to be certified and implement an ISO system of one type or another.