Hi Darrell et al, Traceability is the key here. And, it is up to the manufacturer to implement the process that works best and which also provides that traceability for the inspectors when they visit. Getting the inspectors in-and-out quickly has always been a goal because its better for the manufacturer and for the inspectors. For the Certificate of Compliance (CofC) method, keeping a mountain of paper on file is not preferable, but it is one method. If the manufacturer's quality system dictates it, then those records need to be kept or maybe the quality system needs to be changed. That's a call only the manufacturer can make, however. In my experience from many past lives, traceability has taken the form of CofC's, part marking, design drawings, and audits of the molder(s). Part marking involved part number, molder & material ID's. The audits were done by the agency inspectors referencing shipping invoices, PO's, etc. Any of these methods have been acceptable to inspectors. It's worth noting here that in one instance an inspector said to change a wire harness design drawing to include the wire insulation thickness on the drawing to establish traceability, but that's another story. As Rich has stated, the CofC method is at the mercy of the incoming inspection function. Unless these people are well trained and committed to look for and retain the CofC's, the CofC's will be lost. And, having a thousand boxes arrive all at the same time will only compound this. To lighten the CofC paper load the manufacturer might have the vendor supply the CofC's in electronic format or convert the CofC's to electronic format. A CD-ROM might contain an entire file cabinet and a hard disk would almost certainly contain many file cabinets. With all this said, appeasing the inspectors is important, however, they are not the ones who set the rules. They are there on the front lines only to ensure the product(s) are being built to the same level as the one(s) that were initially evaluated. For an efficient inspection visit, this is where established traceability of components and materials is imperative. Also, established traceability should prove extremely beneficial in product liability litigation should that ever happen, heaven forbid. But, I'm sure you already know that. Pardon my rambling and I hope I haven't wandered too far off base. Best regards, Ron Pickard ron_pick...@hypercom.com
______________________________ Reply Separator _________________________________ Subject: Re: Plastics Cert Documentation Author: "CTL" <c...@prodigy.net> at INTERNET List-Post: emc-pstc@listserv.ieee.org Date: 11/19/98 9:31 AM I have had sucess in the past with follow-up inspectors by having the plastic material identification molded into the plastic part by the supplier and keeping one cert of flammability on file. I don't know if this is still acceptable to follow-up inspectors. You could check with your inspectors on this point. Best Regards, Pryor McGinnis c...@prodigy.net -----Original Message----- From: Darrell Locke (MSMail) <dlo...@advanced-input.com> To: 'emc-p...@majordomo.ieee.org' <emc-p...@majordomo.ieee.org> List-Post: emc-pstc@listserv.ieee.org Date: Wednesday, November 18, 1998 8:36 PM Subject: Plastics Cert Documentation >Dear Fellow Members, > >We have a plethora of plastic subassemblies, produced by outside >vendors, that are received and stocked in our factory. We must keep >certs of flammability on file for each shipment of every plastic part to >satisfy UL, CSA, and TUV factory inspectors. This involves sorting and >filing lots of paper and maintaing a long row of filing cabinets. The >method seems cumbersome in this electronic age. Does anyone have >experience with easier methods of tracking these certs that is also >acceptable to the agencies. > >Thanks very much > >Darrell Locke >Advanced Input Devices >--------- --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
