Dealing with non conforming materials has become a more time consuming part of my job recently and a topic of debate within the company. The FDA has 21 CFR 820.90 on non conforming product which says:
"(a)Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented."The FDA's definition of product in this case includes components and material. This has been interpreted by many as every nonconformance requires a full on investigation into the root cause and a corrective action, pictures, documentation changes and the whole deal. In fact, some have argued that each non conformance needs a CAPA that must be closed before the material can move on to the next stage. That is all fine and good unless you want to make money, lets be realistic here.
Besides, as a startup most of the corrective actions don't necessarily get too far. Lets say I get one custom cable out of 20 with a bad crimp that gives an intermittant signal. The signal is checked as it leaves the vendor, but since it was intermittant it wasn't caught. The conversation goes something like this:
Me: One of your cables had a bad crimp and the signal was intermittant.
Vendor: We're sorry, we check them 100% before they are sent out, return the cable and we will credit your account the $28 the cable cost or just recrimp it yourself.
I admit that getting after vendors isn't one of my strong points (isn't that for purchasing?), but we need these guys more than they need us- I don't want to source another vendor and then wait for their lead time to get more parts. Now if the cable is miswired or the part tolerance is too tight, then I'll fix the drawing, but our device has many parts and from time to time you're going to run into one off problems that shouldn't require huge amounts of wasted effort.
On the other end of the spectrum, I do know that the FDA will write you up if you just scrap every non conformance below a certain dollar value without explanation or investigation, so that is out of the question. So far I've been unable to convince people to include routine rework in the manufacturing process, this will be fine until nothing gets done because everything is waiting on evaluation and disposition then we will change. The best solution seems to be to link non-conformances with a risk analysis, then spend the majority of your time on the ones that could lead to patient risk or entire lots of incoming material being bad. At least that way I don't spend two hours on four dirty $2 boxes.