One of our Customers (Gambro BCT) sends a SCAR even if it is only one part and a cheap one at that. I received one 2 days ago on a ten dollar part. We have shipped them 6000 of these parts in the last 5 years with no defects. I answered the corrective action that this was normal production fallout and required no corrective action on our part. I have done this before with no problem. This time one of their engineers said I couldn't answer the SCAR that way because their BSI auditor wouldn't like it. Does anybody no of a requirement by ISO 13485 or the FDA that requires a Corrective action to be issued for one stinking part.
Thanks, Ron

If the part was a critical component of a pacemaker, which, in case of failure, could lead to a death, yes.

Without details, is always harder to provide meaningful feedback.

Risk, criticality & nature of the non-conformity can be part of the assessment process to determine the need or not for corrective action, in addition to the frequency of defects.

For a non-critical component, 1 failure out of 6,000 should not trigger a CAR from the customer, imo.

I have to agree with Sidney, it all depends on what the part is used for. If you give us a little more detail we should be able to provide a better response.

On a side note, do you really want to include your customers name in the post???

Now that you have and I've looked them up, I would guess whatever part it was was probably a life/health/safety issue for them.

Let's get away from who the customer is and whether the product was life/health/safety related.

You say you shipped 6,000 parts over a period of time and one (which is what they have found SO FAR) was nonconforming. Are you absolutely certain you know what caused the nonconformity? Are you absolutely certain that was the only one EVER? What are the chances of a future occurrence? Do you expect to ship more parts to this customer in the future? Do you sell this part to other customers or is it exclusive to the customer? Do you control the design or do they? Did anything change in your production or did you ship from stock? Do you normally inspect for the kind of nonconformity they found? Why or Why not?

My point here is that our business as Quality Professionals is to be "professional." My definition of a professional is that he does a good job every time, whether his heart is in it or not. Whether the job is big or small. Are you being professional in this matter?

If I can think of all these questions off the top of my head at 6:30 am while I wait for my first cup of coffee, did you think of them as you fumed at the SCAR? I bet the guy who wrote it up did!

One of our Customers (Gambro BCT) sends a SCAR even if it is only one part and a cheap one at that. I received one 2 days ago on a ten dollar part. We have shipped them 6000 of these parts in the last 5 years with no defects. I answered the corrective action that this was normal production fallout and required no corrective action on our part. I have done this before with no problem. This time one of their engineers said I couldn't answer the SCAR that way because their BSI auditor wouldn't like it. Does anybody no of a requirement by ISO 13485 or the FDA that requires a Corrective action to be issued for one stinking part.
Thanks, Ron


In my opinion, it doesn't matter what the cost of the part is/was, YOUR CUSTOMER rejected it for not complying with their requirements and/or drawings. This should be properly investigated to see if there are others with the same or similar defect. If I would have been your customer, I too would have requested a Corrective/Preventative Action.

What would would happen if this was a life/death/safety issue which could create so legal headaches for your company.

Remember, with out your customer (s) you would have no more business.


Coury Ferguson

At issue with customers is more than the part's cost. What it costs them to recover from a supplier's part that gets embedded in their end product is a reasonable source of concern. Their share of responsibility and/or publicity for end results means they have the right to ask their suppliers for corrective action.

Consider a tiny component in a fuel pump. When a car maker's fuel pumps quit during freeway driving, no one shows sympathy that the pump has components the car maker doesn't produce. All eyes are on the car maker and the costs of recalls are enormous. I won't talk about litigation.

So I agree I would make a policy of diligent response to such complaints.

Without knowing anything about the product in question, I have to echo the others here. It's quite simple really: Should the day come when I need help to keep me alive I would very much prefer that all component parts of the contraption doing that job are functional. I am not going to care one bit how much any of those parts cost.

I would regard the SCAR as valuable information, to be used for assuring a safe process.

/Claes

Thanks to everyone for your valuable answers. The part in question is a non critical part and is part of a latch assembly. The latch worked but it wasn't at the correct angle which was determined by an eyeball check. There was a weld issue which caused the problem. We also do work for another ISO 13485 Certified company and they never send us a corrective action for one part. Now can we please focus on the original question. Does anyone know of any requirements by FDA or the ISO 13485 Standard that requires a corrective action for one noncritical part.

Thanks again,
Ron

Thanks to everyone for your valuable answers. The part in question is a non critical part and is part of a latch assembly. The latch worked but it wasn't at the correct angle which was determined by an eyeball check. There was a weld issue which caused the problem. We also do work for another ISO 13485 Certified company and they never send us a corrective action for one part. Now can we please focus on the original question. Does anyone know of any requirements by FDA or the ISO 13485 Standard that requires a corrective action for one noncritical part.

Thanks again,
Ron


Ron,

To answer your question there are only requirements to take corrective/preventative action.

It still gets back to what your Customer wanted. They (customer) determined that is was important enough to them (Customer) to generate a SCAR, and in my opinion you need to investigate the issue and satisfy your customer's request.


Coury Ferguson

Flat answer: no Standard or regulation (FDA or any other medical) REQUIRES this. However, that's a thin thread to hang your hat on. The statement was that the registrar who examined the QMS of the customer has determined the customer's QMS requires they issue SCAR. This is an entirely different and "political" question.

I see it as two choices:

You can get into a p+++ing contest with the customer, win the argument and lose the client
OR
You can swallow hard and do what is requested and maybe, just maybe, find out something valuable along the way.

Ron, it is only one SCAR in 5 years so just investigate it implement your corective action, answer it and move on. Although there is no hard requirement in the standards, your customer's system may require it. If you don't respond satisfactorily, you risk losing the customer.

The statement was that the registrar who examined the QMS of the customer has determined the customer's QMS requires they issue SCAR.

No, here's what the OP said:
I have done this before with no problem [but] This time one of [the customers'] engineers said I couldn't answer the SCAR that way because their BSI auditor wouldn't like it.

You can get into a p+++ing contest with the customer, win the argument and lose the client

Not necessarily. In this case, it seems like an individual customer representative may not be using common sense, and there's no particular reason that $500 should be spent to address a $10 "problem." True enough, it's easy to write some kind of jive answer that will satisfy the guy and just forget the whole thing, but in my experience, it's almost never a good idea to open that door if you can keep it closed.

You can swallow hard and do what is requested and maybe, just maybe, find out something valuable along the way.


I think we may also be jumping the gun by assuming that (A) the cause is unknown (the OP says it's "normal production fallout") and (B) that there's something that needs to be done that hasn't been done or considered.

Jim is right! We aren't on site. We haven't seen the part nor the nonconformance. We have no idea whether the customer's guy is being a self-righteous rogue or whether he really is following company requirements. I don't think the root cause investigation and subsequent report should be that expensive, but it all depends on the hourly rate of those involved. The report may very well result in "just normal variation in the process and we missed one in inspection" or a real finding that CAN be corrected.

Some of us might have tried to deal with this on a more friendly person-to-person basis on the theory you "catch more flies with honey . . ."

Now, however, the customer's guy is on the defensive and laying it off on a 3rd party registrar. Maybe you can ask something to the effect, "How can you [customer] and I [supplier] put something together that will satisfy your record keeping requirements and your registrar without causing rancor between us?"

The bottom line is that you either have to accommodate the customer or kiss him off to a competitor. If I were a top executive at the customer and discovered my SQA was getting his chain yanked, I'd make sure I did some chain yanking with your bosses.

It is not a matter of whether the SQA is exceeding his authority or is mistaken about the nonconformity. He's merely trying to do the job as he understands it. He may not have leeway to do anything else without jeopardizing his own career.

Thanks to everyone for there valuable answers after I clarified the issue. I will get back to you as soon as I have had a chat with the Car Administrator at the Company in question.
Thanks again everyone!