NPI Qualification Checklist

There is a reference manual called Advanced product Quality Planning(APQP)which were widely use in automotive industry or QS certification company.Inside there has plenty of checklists which may be relevent to you.

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Daan Terstegge, on his excellent site [ http://www.smtinfo.net ], makes several free DFM checklists available for download. Earl Moon contributed couple of them. Moonie has been a generous contributor to the SMTnet Forum and wrote several knowledgeable papers for the SMTnet Newsletter on board fabrication and DFM that are worthy of review. [Sadly, SMTnet 'search' doesn't work on Newletters. So while you're rooting around to find Earl's stuff, you just might other gems.]

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ISO 9001-1994 and ISO 9001-2000 are significantly different regarding 'process'. In the 1994 version, processes were considered to be routine manufacturing processes [eg, drill a hole]. In the new ISO, a 'process' is more global and covers anything that has an input and an output [eg, create an engineering drawing].

Process auditing is another significant difference. Under the old ISO, companies performed audits to determine the level of adherence to procedures to on the shop floor. Under the new ISO, auditing alone is insufficient. Now, companies must establish metrics to measure the effectiveness of the process, and to use the metrics to create continuous process improvement. For example, an engineering metric might be to document how many engineering errors were created during the drawing creation process.

We wonder if most companies realize the bottom line impact of transitioning to ISO 9001-2001. Paper, paper, paper. It doesn't come cheap!!!

We write a different process qualification report for each process. An outline for our report follows: Content 1 PROCESS MAIN SPECIFICATION CHANGE 1.1 Process change/transfer description 1.2 Process main specification change 1.3 Possible effects of change on Parametric, Electrical, Quality or Reliability 2 QUALIFICATION PLAN 2.1 Test vehicle description 2.2 Process qualification requirements 2.3 Product qualification requirements 2.4 Final Test qualification requirements 2.5 Bench Test requirements 2.6 Reliability qualification requirements 3 RESULTS 3.1 Process qualification results 3.2 Construction analysis results 3.3 Product qualification results 3.4 Final Test qualification results 3.5 Bench Test qualification results 3.6 Reliability qualification results 4 PROCESS CHANGE APPROVAL CERTIFICATE

We consider �process qualification� and �process validation� to be identical process terms.

Places to look for addition information are: * Read �Assembly Process Qualification On 0201 Packages For Volume Manufacturing�; Mei Wang et al. Flextronics International; SMTA International; 09/22/2002 [Find this in the SMTA Knowledgebase] as a example of a process qualification. * Find a US FDA document �4 PROCESS VALIDATION� [It�s on the net.]. Virtually everything spins-up from it. * Find �Project 707; TMN X Interface Studies and Experiments for SDH; Deliverable 1; Operational Process Validation Methods" [It�s on the net.]. It�s OK. Eurolanders think too much when they do stuff, like this. * Find "PHARMACEUTICAL INSPECTION CONVENTION, PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME, PR 1/99-2, 1 April 2000" [It�s on the net.]. It's OK, just a little far a field.

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