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component management and traceability, components, definitions, form fit or function, material changes, material qualification, process changes and change notifications, validation (general), materials (general), processes (general), validation of machines equipment processes design etc.
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Old 25th August 2011, 12:24 PM
JoePap01 JoePap01 is offline
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Please Help! Form Fit or Function - Materials Composition and Manufacturing Processes?

Hi Folks.

Been a part of The Cove for a short time, first time posting. Please be gentle...

I've been in Quality for a while (since about 1990 in one aspect or another), in Medical Device since about 2000 and I've recently changed companies, from Class 3 Med Dev Mfg to Class 2. The culture of the new company is slightly different than anything I've seen and there is sometimes a liberal interpretation of "form fit or function." Reading the many definitions and explanations here in The Cove and elsewhere, I have yet to see the concept of material composition or manufacturing process addressed. Also, a common example of debates I've had is related to electronics in that replacing one component with another, especially if the rating (e.g. Military vs Commercial) has changed. My question is, how do you folks handle this from a qualification/validation perspective? My opinion, and I recognize that this comes from years of having to qualify and validate EVERYTHING to some extent, is that there should be some sort of practical evaluation done, not just paper spec review. Is that overkill on my part? It has been argued to me "as long as the finished part meets our specs, why do we care if its machined or molded?" I have a real hard time swallowing that logic but it does meet the general definition of F3.

Any and all comments and advice is welcomed. If I'm justified, let me know and if I'm out of line, let me know that, too. Thanks in advance for any assistance!

Joe

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Old 25th August 2011, 01:22 PM
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Re: Form Fit or Function - Composition?

Funny thing: I'm currently on a break from teaching a class in my organization on how to assess and validate changes...

The thing we need to remember is that any change (material composition, component grade, supplier, processing change) must be assessed and appropriately tested for it's potential affect on the form. fit or function of the system it is going into. We can also think of this as: does the material composition change potentially affect the material's form, fit or function?

I also advise that if the function of the component or material is in the final product critical functional path we should test in some way for unintended changes or unknown changes.

I've seen too many 'simple' data sheet compares crash a product...

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Old 25th August 2011, 01:29 PM
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Re: Form Fit or Function - Composition?

Quote:
In Reply to Parent Post by JoePap01 View Post

Hi Folks.

Been a part of The Cove for a short time, first time posting. Please be gentle...

I've been in Quality for a while (since about 1990 in one aspect or another), in Medical Device since about 2000 and I've recently changed companies, from Class 3 Med Dev Mfg to Class 2. The culture of the new company is slightly different than anything I've seen and there is sometimes a liberal interpretation of "form fit or function." Reading the many definitions and explanations here in The Cove and elsewhere, I have yet to see the concept of material composition or manufacturing process addressed. Also, a common example of debates I've had is related to electronics in that replacing one component with another, especially if the rating (e.g. Military vs Commercial) has changed. My question is, how do you folks handle this from a qualification/validation perspective? My opinion, and I recognize that this comes from years of having to qualify and validate EVERYTHING to some extent, is that there should be some sort of practical evaluation done, not just paper spec review. Is that overkill on my part? It has been argued to me "as long as the finished part meets our specs, why do we care if its machined or molded?" I have a real hard time swallowing that logic but it does meet the general definition of F3.

Any and all comments and advice is welcomed. If I'm justified, let me know and if I'm out of line, let me know that, too. Thanks in advance for any assistance!

Joe
Welcome. You're not even close to being out of line, so don't fret.

The problem with the 3F concept is that it's usually used to justify using nonconforming parts or products, and too often nothing is done with the specifications. If a thing is usable but nonconforming, there's probably something wrong with the specs.

The other thing is that from the perspective of a single piece, it's easy to say that it doesn't matter whether it's stamped or laser-cut or machined or whatever, but it can make a big difference when you have to make hundreds or thousands or tens of thousands of them. A few functional parts isn't evidence of process capability.

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