ISO 9001 implementation at a prototyping shop

[fwilsonNY]

Title of the thread may be a little vague, but I am not quite sure how to summarize my dilemma in one line. I have been lurking now for a few weeks and learned a lot that has helped me out, but now I am have hit kind of a mental brick wall and have no higher expert on the subject here at work so I figured it couldn't hurt to ask the knowledgeable people here. Just a quick summary of where I am at and if anyone has any input I would greatly appreciate it.

I work for a company specializing in rapid design and manufacture of low production and prototype parts. Primary industry is motor racing, however over the past few years the business has been expanding into engineering services and low volume/rapid timeline manufacturing. The new business areas involve automotive suppliers, R&D centers and defense contractors/subcontractors. Implementation of ISO 9001 is going to be beneficial in our business in these areas, and could possibly be required by a few customers in the future.

I have have been tasked with the majority of the implementation leg-work and have been working on it fairly exclusively for almost a month and a half and have found many helpful answers from reading threads here, but have also had even more questions raised in certain areas.

My current dilemma is basically how to NOT detrimentally affect what makes us appealing to our customers, our ability to apply racing-esque timelines and techniques to their products. Only a few of our parts are made in batches in the hundreds, and they are for our racing programs and usually produced once a year. The engineering services projects that have parts manufacture included have never had more than 50 of a particular part made. CNC lathes and mills constantly have new jobs. Designs are usually developed on a fairly rapid timeline in comparison to normal practice. If we limit these features of the business it will hurt our appeal to these customers (some with possibly fairly lucrative long term relationships if they continue to be pleased). However, they also want (or may in the future) ISO 9001 certification. I feel I am in a kind of catch 22 here and feeling maybe a bit overwhelmed by the situation, especially with feeling a bit of pressure from various management people in different direction.

I know I dont really have a single outright question, maybe what I'm really looking for is a bit of support from people who have been there before so I don't like I want to right now. My background is not in quality, but I started working as an inspector in our recently officially founded quality department early this year to make more money than working as a research assistant at a university while working on my MS in Mech Eng. After they saw I was competent (I assume) they had me start working on Quality management stuff and that evolved into ISO 9001 implementation. I feel I have made pretty good progress thus far and have a good idea of what I must do in most areas. Well thats all for now, I'm a bit fired up and could go on and on. If you guys or gals think you could give me a helpful tip with a bit more info just ask and I will tell if I am able. Thanks.

 

[Sidney Vianna]

Re: ISO 9001 implimentation at a prototyping shop

My current dilemma is basically how to NOT detrimentally affect what makes us appealing to our customers, our ability to apply racing-esque timelines and techniques to their products.

You need to ensure that RESPONSIVENESS remains at the heart of your processes, corporate culture and the whole workforce understands it. A great candidate for a perennial quality objective.
The key for you is to ensure that, as you develop your processes, you keep in check any non-value added bureaucracy and not let busy work creep in your modus operandi. On the other hand, short cutting processes and allowing substandard parts to leave the shipping dock can cost you, as well.

 

[Colin]

A properly implemented ISO 9001 based QMS will not stop you doing any of the things you hold dear. The key is to define (and document where you choose/need to) your existing processes and then cross check with the standard to see where you have met the requirements and where you have not. You then 'fill in the blanks' and away you go!

 

[Stijloor]

Title of the thread may be a little vague, but I am not quite sure how to summarize my dilemma in one line. I have been lurking now for a few weeks and learned a lot that has helped me out, but now I am have hit kind of a mental brick wall and have no higher expert on the subject here at work so I figured it couldn't hurt to ask the knowledgeable people here. Just a quick summary of where I am at and if anyone has any input I would greatly appreciate it.

I work for a company specializing in rapid design and manufacture of low production and prototype parts. Primary industry is motor racing, however over the past few years the business has been expanding into engineering services and low volume/rapid timeline manufacturing. The new business areas involve automotive suppliers, R&D centers and defense contractors/subcontractors. Implementation of ISO 9001 is going to be beneficial in our business in these areas, and could possibly be required by a few customers in the future.

I have have been tasked with the majority of the implementation leg-work and have been working on it fairly exclusively for almost a month and a half and have found many helpful answers from reading threads here, but have also had even more questions raised in certain areas.

My current dilemma is basically how to NOT detrimentally affect what makes us appealing to our customers, our ability to apply racing-esque timelines and techniques to their products. Only a few of our parts are made in batches in the hundreds, and they are for our racing programs and usually produced once a year. The engineering services projects that have parts manufacture included have never had more than 50 of a particular part made. CNC lathes and mills constantly have new jobs. Designs are usually developed on a fairly rapid timeline in comparison to normal practice. If we limit these features of the business it will hurt our appeal to these customers (some with possibly fairly lucrative long term relationships if they continue to be pleased). However, they also want (or may in the future) ISO 9001 certification. I feel I am in a kind of catch 22 here and feeling maybe a bit overwhelmed by the situation, especially with feeling a bit of pressure from various management people in different direction.

I know I dont really have a single outright question, maybe what I'm really looking for is a bit of support from people who have been there before so I don't like I want to right now. My background is not in quality, but I started working as an inspector in our recently officially founded quality department early this year to make more money than working as a research assistant at a university while working on my MS in Mech Eng. After they saw I was competent (I assume) they had me start working on Quality management stuff and that evolved into ISO 9001 implementation. I feel I have made pretty good progress thus far and have a good idea of what I must do in most areas. Well thats all for now, I'm a bit fired up and could go on and on. If you guys or gals think you could give me a helpful tip with a bit more info just ask and I will tell if I am able. Thanks.

I am currently working with a Client with ISO 9001:2008 QMS implementation that is engaged in the same type of work you do. The whole company is 5 emloyees strong. Their core-competencies are extremely high precision CNC maching (turning/milling) and very quick turnaround. Sounds familiar? We looked at the current processes, fine-tuned them even more trying to leverage their unique capabilities and let the requirements of ISO 9001:2008 be a nice framework for today and the future. We are implementing the system with potential growth in mind.

A very interesting challenge indeed.

Stijloor.

 

[AndyN]

and, of course, you'd want to choose a CB who understands and is empathetic to the challenge!

 

[fwilsonNY]

I am currently working with a Client with ISO 9001:2008 QMS implementation that is engaged in the same type of work you do. The whole company is 5 emloyees strong. Their core-competencies are extremely high precision CNC maching (turning/milling) and very quick turnaround. Sounds familiar?

Seeing where you are located thats not suprising. NC is one of the tribunal of American racing company locations. The company I work for is quite a bit larger than that with approximately 150 employees in two locations, one in Michigan and one in North Carolina. We will only be imlimenting at the Michigan location which does the majority of the engineering and all of the manufacturing. NC is where the NASCAR support team and some of our CFD wizards and their supercomputer are located.

A very interesting challenge indeed.

Yes it has already proven to be for me. We have a machine shop, metal fabrication shop and composites shop. Like I said, our original and still primary business is auto racing, from design and development to building and then finally to testing and racing. However the other areas are growing quickly and with racing being cyclical with the economy and availability of sposors and manufacturers interested in going racing they are crucial to our continued growth. Most of the people working here are racers, so adapting some of the way they do things when required by ISO or even when an area for improvement for outside customers is noted it can prove difficult. Support for the implementation is growing as people realize that I am not here to make everyones job differently, that I am instead trying to document with the intent of improving what we do so we all still have jobs. It has been getting better. Thanks for the responses thus far from all three of you. You have definitely reinforced my thoughts on how I am going about this instead of tearing them down. I am trying to keep a good attitide about this, and this forum has already helped quite a bit.

Sydney, as for the comment about substandard parts leaving, we do our best to prevent this even without a QMS in place by performing 100% (or very close to it) inspections of critical dimensions. Haven't had any major issues since I have been here with parts being out of customer specs or failing in service. Well, a few parts have broken, but what do you expect when a driver stuffs the racecar into the barrier at speed.

 

[Sidney Vianna]

and, of course, you'd want to choose a CB who understands and is empathetic to the challenge!

Is there any CB that doesn't fit that description?

Sydney, as for the comment about substandard parts leaving, we do our best to prevent this even without a QMS in place by performing 100% (or very close to it) inspections of critical dimensions. Haven't had any major issues since I have been here with parts being out of customer specs or failing in service. Well, a few parts have broken, but what do you expect when a driver stuffs the racecar into the barrier at speed.

My comment had to do with extremely compressed delivery schedules. In motor racing, suppliers, many times, are faced with the challenge of shortcutting some steps in order to get the part out for a critical qualifying session, 4 hours away. So, management, sometimes allow this type of "expediting", which, some times, prove disastrous...How many races are lost due to a failure of a single component....
Anyway, keep us appraised of your challenges. there are a few of us who are motor-racing fans. Formula 1 fanatics

 

[AndyN]

I had seen, a few years ago, a headline on an article that claimed that a prototype shop "would have taken longer to turn around work, if they followed ISO procedures:

Clearly, the folks who wrote that, had no idea of what was required by ISO 9001!

Despite a number of significant differences in products (individual, even if not 'classification'), the processes of doing business in the shop are very much the same for all jobs and, not surprisingly, those processes have problems associated with them. So by defining them, monitoring the performance and taking action, there should be less and less time taken up dealing with problems......hence reduced turn around times.....

Thinking about the (NASCAR) racing team analogy, it's a bit like looking at the wheel change team working. They represent the optimal implementation of a well defined process, with competent people who know their stuff etc. etc.

When I try to explain what a good system looks like, I've found sports analogies are a great way to explain to many folks who don't speak "ISO".

 

[John Broomfield]

Do not implement ISO 9001. Understand your existing system instead. That is the system that runs the business. Ignoring this system and layering it with more procedures will be counterproductive.

Study your existing system. At a high level analyze your core process or processes for converting customer needs into cash in the bank. This should determine the key processes essential to the core process. Then you will need to determine the key processes necessary to support the core process such as recruiting and training etc... Then identify the process owners (subject matter experts).

Work with each of them to analyze their key process in-depth linking to any forms and instructions that are used and each of the interacting processes. Use a deployment flowcharting tool to record the results of your analysis.

It also helps to train as an auditor so you know what questions to ask when doing the process analysis.

Make sure the process owners obtain confirmation of the as-is situation from the process teams and their internal customers.

Some new key processes will be required. They comprise 5 to 15% of the management system effort (rarely more).

Each of these new key processes is designed per clause 7.3 using the relevant clause (such as 8.2.2) as input additional to the process objective.

But first the organization's inherent system needs to be exposed, understood and documented to the extent necessary for effective planning, operation and control in the manner I have described (but I am always ready to learn of a better method).

This approach of not "implementing the standard" results in better understanding of the system that is running the business and one that also happens to conform to the system standard.

"Implementing the standard" is how some organizations end up with "ISO systems" and some of these are even kept on the I-drive!

 

[AndyN]

Do not implement ISO 9001.

John, now I know you don't really mean this, so for the 'newbies' who come here and leave with advice, you may wish to reconsider such a sweeping statement and modify your, philosophically correct but technically flawed, statement!

Most businesses don't do all of what ISO 9001 requires - take audits as an example. If they didn't implement 'ISO' they be in non-conformance wouldn't they? Not much good if you want an effective system or even want to be certified......