Safety Characteristics & capability studies

[JSmith]

Please help,

We've been having discussions within my origanization regarding the necessity of ongoing analysis of data / capability studies on Safety Characteristics. Are these studies necessary for ongoing monitering? We currently have controls in our process that 100% verifies the welds and we also do destruct tests daily. Is this acceptable if the weld is an SC?

If it is acceptable to do 100% verification in liau of ongoing SPC/ Capability studies, could you please tell me where this is defined?

Thanks so much for you help.

Jen

 

[The Taz!]

Hope this helps. . . actually, ongoing SPC and Cpk (and maintaining PPAP Quality Level) is a requirement for all Safety and Critical (also customer designated significants on the DFMEA, PFMEA, and PCP).

100% Inspection of THOSE characteristics is required when Ppk or Cpk are unsatisfactory and do not meet requirements.

I am no welding expert, but unless something has changed, those are the requirements I am familiar with.

 

[JSmith]

Hi Taz,

Is that defined/documented anywhere within one of the requirements manuals? ie PPAP, SPC?

Thank you so much for your help.

 

[ralphsulser]

See PPAP Manual Section 1.2.2.9.6, page 8. This spells out what requires 100% inspection if you can't meet 1.33 Cpk by PPAP submission time.