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Q.6 RFC Component v. Unit and 3rd party testing

 
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Eric H
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PostPosted: Sun Dec 21, 2008 10:47 am    Post subject: Q.6 RFC Component v. Unit and 3rd party testing Reply with quote

The table of contents for all the questions in the RFC, including an explanation of what an RFC is can be found at Introduction and Table of contents: RFC Component vs unit and 3rd party testing

This section deals with the sixth question which is:
Quote:
What changes in inventory control methods, if any, should be required if third-party testing of component parts were permitted. Address receipt, storage and quality control of incoming materials, management and control of work-in-process, non-conforming material control, control of rework, inventory rotation, and overall identification and control of materials.


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Eric H
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PostPosted: Sun Dec 21, 2008 12:14 pm    Post subject: Reply with quote

This is a very astute question on their part.

My first thought on this is that manufacturers must be very careful to keep their tested components stored separately from non-tested components, if they mix them at all. They must have a methodical labeling and storage system. ISO 9001 has similar requirements for storing documentation. OSHA has similar requirements for training employees about such things as hazardous materials communication (MSDS) right-to-know stations, job hazards, and the like.

From a compliance standpoint, it seems like you could safely give less scrutiny to a company with an ISO certification. Lacking that, if they could demonstrate a system for doing these things, then they're probably going to be less of a problem then a business that was randomly buying stuff off of e-bay and garage sales and mixing it all together.

Record-keeping could get complex. Let's say you bought cotton cloth in two lots, and then dyed it with the same red color, but two different lots, you could have as many as four combinations of dyed cloth, even though it was all (from your standpoint) the same input ("red cloth"). If they broadly exempted unfinished cotton cloth, this reduces back to two lots because of the dyes. Worthwhile?
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Vesta
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PostPosted: Mon Dec 22, 2008 3:21 pm    Post subject: Reply with quote

It's a lot of work, but this seems like it is part of the lot tracking issue. Keep meticulous track of incoming components, linked to test results (whether your own or the supplier's results), make sure all unused rolls are tracked, make sure your batch IDs are linked to the specific inputs used. Once a finished product has been assigned a lot #, it's done. Wherever the product goes after that, it's trackable to the components.

Yes, it's going to be boucoup paperwork, especially if you're buying random components in small lots. But it's work that will have to be done if we are going to use component testing. As far as we're concerned, since we only make children's products, we won't let anything in the doors that doesn't comply.
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Melissa McKeagney
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PostPosted: Fri Jan 02, 2009 8:37 am    Post subject: Reply with quote

A manufacturer would need to make sure that there is a system for labeling and tracking incoming components, and have that tracking linked to the test results and the final units.

The manufacturer must have an inventory system where untested components be kept separate from tested components. If a component is proven to be non-compliant, there must be a “quarantine” area to which workers on the floor do not have access. Then the manufacturer would need to make the determination whether to return that component to the initial manufacturer, scrap the component, or use it in a different manufacturing application.

There must be coordination between the inventory control and tracking system and the physical location in the facility. Once a component has been tested, logged, and stored that component must still be traceable to the final product by assigning batch ID#’s.

Both of you stated this very well, but I wanted to bring this back up to the top to see what others might write. I am struggling!!
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