J
JoePap01
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
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
You're not even close to being out of line, so don't fret. 
