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critical suppliers, iso 13485 - medical device qms, medical device company or industry, 21 cfr part 820 - med. device mfger. qsr requirements, supplier evaluation/rating/approval
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  #1  
Old 15th February 2005, 02:03 PM
Gerry Quinn Gerry Quinn is offline
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Please Help! Choosing Supplier Evaluation Methods - Determining what a Critical Supplier is

Over the many years that I have been in the quality field, I have seen the term "Critical Supplier" used many times. In all of that time I have yet to see a good definition of that term. Most people tell me that "you know one when you see one". Well that hasn't done me any good.

The use of this term has been associated with the level of effort to be expended in evaluating a supplier or a potential supplier. Is the supplier and his product so important that we have to do everything possible to evaluate and document, or can we just check to see if he has a pulse and a telephone.

I work in the medical device industry and attempt to comply with 21CFR820 and ISO 13485:2003.

I have attempted to develop a set of questions (attached) to determine if the supplier needs to be evaluated at all and a matrix of possible evaluations that could be performed.

What I am looking for is a process that is fool proof. Ask the questions, get the answers, go to the matrix and find the acceptable evaluation method.

I'm stuck. Any ideas?

Gerry
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  #2  
Old 15th February 2005, 05:03 PM
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Wes Bucey Wes Bucey is offline
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About a million years ago, someone came up with PERT/CPM (Project Evaluation Review Technique/Critical Path Method)

It helps identify the critical points in a process or project so the project manager can give those points special attention.

When we deal with suppliers, we try to identify those suppliers whose lead times and other characteristics having to do with delivery and conformity of the product or service have a huge impact on the balance of the project.

There is an old poem which begins, "For the want of a nail, the shoe was lost, for the want of the shoe, the horse . . ."

In a sense, all suppliers are critical, but some are so critical to the success of the project that their failure to perform is not easily remedied by finding another supplier because of long lead times or lack of capacity or even capability. When such "critical" suppliers are in a supply chain, managers routinely "hedge their bets" by creating stockpiles of safety stock and/or alternate suppliers in the event disaster should strike the critical supplier.

In the poem, the critical supplier was not the nail manufacturer, but the blacksmith who installed the shoes.

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Last edited by Wes Bucey; 15th February 2005 at 05:05 PM.
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Old 15th February 2005, 08:12 PM
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Quote:
In Reply to Parent Post by Gerry Quinn

Over the many years that I have been in the quality field, I have seen the term "Critical Supplier" used many times. In all of that time I have yet to see a good definition of that term. Most people tell me that "you know one when you see one". Well that hasn't done me any good.

What I am looking for is a process that is fool proof. Ask the questions, get the
answers, go to the matrix and find the acceptable evaluation method.

I'm stuck. Any ideas?

Gerry
How about "Would our final customer care/notice if this supplier messed up?"

Spring for heart valve replacement- YES
Design services - YES
Lawn care - NO
ISO registrar - Hmmm?
Training Provider - Hmmmm?

Maybe not so simple as I thought.

Hmmm who is the customer - patient or FDA - or both?

More questions than answers tonight - sorry
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Old 17th February 2005, 11:08 AM
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Hello Gerry!
Quote:
In Reply to Parent Post by Gerry Quinn

What I am looking for is a process that is fool proof. Ask the questions, get the answers, go to the matrix and find the acceptable evaluation method.
I think you are asking the wrong question:
Don't ask which of your suppliers is a critical one or not. (and besides, there could be quality critical ones, or business (money) critical ones, or... or... or...)
I think you are looking for quality critical ones.

So take a look at your product and determine the critical components. The suppliers who deliver these components are the critical ones.

I would start with a risk assessment of the product (ISO 14971 could help you).

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  #5  
Old 17th February 2005, 11:55 AM
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Quote:
In Reply to Parent Post by wrodnigg

Hello Gerry! I think you are asking the wrong question:
Don't ask which of your suppliers is a critical one or not. (and besides, there could be quality critical ones, or business (money) critical ones, or... or... or...)
I think you are looking for quality critical ones.

So take a look at your product and determine the critical components. The suppliers who deliver these components are the critical ones.

I would start with a risk assessment of the product (ISO 14971 could help you).
Hello Gerry:

wrodnigg is correct. There are many ways of viewing the word "critica", but, to quote my well repeated slogan, "never lose sight of the product."

You might consider what other industries and the engineering profession would do. Ask your product designers to undertake a "Failure Modes and Effects Critical Analysis" or FMECA. This is shortened in the automotive industry to be "FMEA". The former was being used many decades ago by nuclear engineers working in the western nuclear power industry - to my certain knowledge, as I once worked in that sector.

Perhaps your designers already have done such an exercise. If so, it should reveal a "ranking" for each component, assemble, part, sub assembly etc. This can be used as a guide in deciding which supplier then is "critical" in that if it delivers defective product, you know the risk to health, safety and of litigation.

As an example: I once authorized an audit of a supplier delivering a particular component whose unit cost was less than $100. The audit cost almost $15000. But, since that item was to be welded into a main pipeline in contact with the nuclear reactor pressure vessel, it was certainly "critical". Its failure would cause a major incident.

But, even if your engineers have actually adopted FMECA (or FMEA) or used fault tree analysis (FTA) is is also important that you thoroughly audit their activities. For this you may need to engage the services of a specialist in your particular field, which I understand is the medical industry. That is because you MUST have confidence in their actual process, methods, analysis and so forth.

I hope this helps.
Thanks to AllanJ for your informative Post and/or Attachment!
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Old 18th February 2005, 04:28 AM
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BIG Smile Supplier Evaluation

Quote:
In Reply to Parent Post by Caster

How about "Would our final customer care/notice if this supplier messed up?"
Definitely the way to view it.

We just use a simple rating system based on quality price and service. If you keep supplier evaluation simple then sorting out the critical from the merely important becomes a moot point.

The guy who services the photocopier can still stuff you up.
  #7  
Old 18th February 2005, 05:55 AM
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I agree with MikeL. This is an area that can get very complicated, very quickly without a significant increase in benefits. Try to keep things simple, review the performance regularly and try to maintain links with your key suppliers

Hope my first post helps!!!!
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Old 23rd February 2005, 09:47 AM
Gerry Quinn Gerry Quinn is offline
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Thanks for the input. I lost sight of the fact that the engineers and designers play an important part in defining the critical nature of products.

Gerry
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