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4.9.1 Process Monitoring & Operator Instructions

L

Linda Jurasin

#1
The company I work for designs, manufactures & markets automated systems for the automotive industry. I am looking for some input with regard to a process currently in use. I need to understand if we are compliant to the QS9000/TE standard. The majority of the jobs have routings that list all the steps (by operation number) to be performed by the operator. My concern is with jobs that have a routing with only one operation which reads "assemble complete". Operator experience, knowledge & training is key. Engineers & production supervisors can oversee/guide the process. The operator usually assembles the product in a manner that mocks assembly of a similar product. Nothing is documented regarding the steps or instructions taken to complete the assembly. These types of jobs may be built only once; then again, may be built once every three or four years. These are not termed as prototype units. Since the routing doesn't describe each step of the process including applicable testing, is this a discrepancy?
 
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Marc

Hunkered Down for the Duration with a Mask on...
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#2
I would want to see the process flow diagram and control plan and to discuss the operation you're talking about. IMHO if your folks are 'trained' and you have evidence, that part would be sufficient for me. As far as the missing steps in the router, the key will be what triggers the 'extra' operation. Proof of that your system should include info from your nonconformance system (actually lack of incidents) to prove your methodology works.

There is no requirement for router content per se that I am aware of. There is a requirement that you have a process flow diagram, PFMEA, DFMEA and control plan for automotive products - with consideration to the T&E Supplement requirements.

You say the router doesn't describe the tests performed. How do folks know when to test, what to test and how to test? If you have no documentation, training plays a part for assembly but doesn't address the triggers necessary to get this stuff to happen during 'production', such as it is.

Have you used the new QSA for the new T&E Supplement which just came out? That can provide an insight into where you're at in so far as compliance goes.

Reading 4.9 of the newest T&E Supplement, there is the 'appropriate' in 4.9.1 that allows you to set up systems 'appropriate' for your product.

4.2.3 of the T&E Supplement has the FMEA requirement and 4.2.3.7 has the control plan requirement. These are the documents I would want to review and follow through with on the floor.

I'm not a T&E guru - Maybe one will stop by and provide some better insight.

[This message has been edited by Marc Smith (edited 09-10-98).]
 
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