Hi Folks,

We are a medical device manufacturer of Class I and II devices. Currently our QC department is requiring all of our component suppliers to provide us with a C of C with all shipments which is extremely detailed. We perform a complete incoming inspection of all components to identified dimensions and document these. We do not have a ship to stock or skip lot program and have no intention of implementing one currently. None of our customers require that we have these C of C's or that we supply them with our shipments of our finished goods to them. My question is this...Does either 21CFR Part 820 or ISO 13485:2003 require you to obtain detailed C of C's from your component suppliers if you are going to inspect the parts anyway and document this activity? I see it as a piece of paper which is meaningless and a total NVA activity. I can see requesting documentation that verifies they used the correct material (as we cannot verfiy that), buy beyond that it's a waste of paper and energy. Any thoughts, comments or advice would be greatly appreciated. Thanks in advance. :confused:

Hi Folks,

We are a medical device manufacturer of Class I and II devices. Currently our QC department is requiring all of our component suppliers to provide us with a C of C with all shipments which is extremely detailed. We perform a complete incoming inspection of all components to identified dimensions and document these. We do not have a ship to stock or skip lot program and have no intention of implementing one currently. None of our customers require that we have these C of C's or that we supply them with our shipments of our finished goods to them. My question is this...Does either 21CFR Part 820 or ISO 13485:2003 require you to obtain detailed C of C's from your component suppliers if you are going to inspect the parts anyway and document this activity? I see it as a piece of paper which is meaningless and a total NVA activity. I can see requesting documentation that verifies they used the correct material (as we cannot verfiy that), buy beyond that it's a waste of paper and energy. Any thoughts, comments or advice would be greatly appreciated. Thanks in advance. :confused:You can find that answer by reading the regulations(21cfr820) and ISO 13485. That it is the best advice I can give someone involved in the manufacture of a medical device.

Speedracer:

If it isn't required by your customers then it a waste of paper.

However, my question is why are you duplicating the inspection effort if your supplier is already performing and providing you the results? That seems a little more costly.

Maybe you need to randomly perform inspections of parts submitted by your suppliers, and rely on your suppliers a little more.


Coury Ferguson
Program/Contracts Manager

You can find that answer by reading the regulations(21cfr820) and ISO 13485. That it is the best advice I can give someone involved in the manufacture of a medical device.

Al - Thanks for the reply. I've read the regulations and I cannot see a clear requirement for a C of C. I was just asking here to see if I missed something or someone had already dealt with this issue.

If it isn't required by your customers then it a waste of paper. However, my question is why are you duplicating the inspection effort if your supplier is already performing and providing you the results? That seems a little more costly. Maybe you need to randomly perform inspections of parts submitted by your suppliers, and rely on your suppliers a little more.

Coury - Thanks as well, and I couldn't agree with you more. Our suppliers do not submit reports of their inspections with their shipments, though our audits reveal they do perform inspection. Unfortunately we are way understaffed in the supplier development group and senior management doesn't look at this as a possible cost savings. My desire is to dump the C of C requirement and streamilne the process for our suppliers to concentrate on component quality not mountains of meaningless paperwork.

May I suggest the ideal solution would be to work toward a "partnership" with these suppliers so the C of C is converted to a usable process/program which CAN lead to a dock to stock program with confidence on all sides that the product/components are, indeed, fully conforming to your requirements.?

Inherent in such a program is making a distinction between suppliers who give you off-the-shelf components and those who make components or assemblies to your design.

If you keep adequate records of incoming shipments, you will be able to determine whether some suppliers of off-the-shelf products can be trusted to consistently supply conforming goods. If you find you can't trust them, it seems you have a problem to solve.

With custom-made goods to your design, you need to spend a lot of time getting familiar with the Control Plan and inspection methodology at the supplier to build toward the trust to include their shipments in a dock to stock program. There are benefits for customer and supplier in such a relationship - supplier trusts he can keep business if he continues to perform well, customer can reduce direct costs of incoming inspection and free up personnel to travel to suppliers to audit their processes from time to time to assure practice follows written plan.

All in all, I would not immediately plan to scrap the current C of C program as much as to make it really viable by aiming toward a future where dock to stock is routine.

Hi Folks,

We are a medical device manufacturer of Class I and II devices. Currently our QC department is requiring all of our component suppliers to provide us with a C of C with all shipments which is extremely detailed. We perform a complete incoming inspection of all components to identified dimensions and document these. We do not have a ship to stock or skip lot program and have no intention of implementing one currently. None of our customers require that we have these C of C's or that we supply them with our shipments of our finished goods to them. My question is this...Does either 21CFR Part 820 or ISO 13485:2003 require you to obtain detailed C of C's from your component suppliers if you are going to inspect the parts anyway and document this activity? I see it as a piece of paper which is meaningless and a total NVA activity. I can see requesting documentation that verifies they used the correct material (as we cannot verfiy that), buy beyond that it's a waste of paper and energy. Any thoughts, comments or advice would be greatly appreciated. Thanks in advance. :confused:

We are a contract manufacturer of Class II medical devices. In the past, we did not require C of C's from our vendors and we maintained ISO13485 registration and met the requirements for 21CFR Pars 820. Our customers and our auditors were all happy with this set up. We required the certs of material, and inspection records from our vendors, but no C of C's.

We also perform detailed receiving inspections because skip lot is not feasible. We are a job shop that runs a product once, and may or may not ever make that product again so we must verify each incoming lot from our vendors to verify their process and gaging technique. I know that many will believe our receiving inspections are a waste of time if we have vendor data, but our products are very complicated and gaging technique is critical. The vendors have not always performed these correctly despite continuous communication.


Unfortunately, one of our customers has changed their requirements recently and we must now have a C of C on file for all outsourced operations. IMHO, the C of C's are a waste of time, escpecially when you have the material and inspection results. I do not know how this piece of paper reduces our risks in any shape or form.

Al - Thanks for the reply. I've read the regulations and I cannot see a clear requirement for a C of C. I was just asking here to see if I missed something or someone had already dealt with this issue. There is no specific requirement for a c of c. In part 21cfr820.80 states Incoming product shall be inspected, tested or otherwise verified as conforming to specified requirements.ISO 13485 7.4.3 states in part,The organization shall implement the inspection or other activities necessary for ensuring purchased product meets specified purchase requirements.So if you are inspecting at incoming, you don't need a c of c.

IMHO, the C of C's are a waste of time, escpecially when you have the material and inspection results. I do not know how this piece of paper reduces our risks in any shape or form.

They do nothing to reduce risk, and as I've pointed out before, they have no special legal standing. They mean nothing. It's long been recognized in the US that shipping against a PO in which requirements are stated or referenced is a tacit but legally binding "certification" that the requirements have been met. I've had situations in the past where pointing this out to customers has resulted in the requirement being dropped, but some others still insisted on the worthless "certificate."

:) Thanks so much for the great replies. We are meeting as a group tomorrow to discuss this issue and I plan to use some of the logic presented here in our discussion. Take care everyone. :agree1:

C of Cs are useful for confirming processing requirements that cannot be inspected. For example, passivation, heat treatment, ultrasonic cleaning, etc. In other words, validated processes. Of course, the piece of paper means nothing unless you have confirmed that your supplier has validated those processes. If you specify that a supplier provide you a part made to a specific standard, it's common to request the supplier to provide parts with a C o C confirming that the parts meet that standard.