G
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.
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
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