Primary & Secondary Inspection Definitions - Incoming, In-process & Final Inspection Medical Device and FDA Regulations and Standards News Other Medical Device and Orthopedic Related TopicsįDA News USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management
I see the things that way, but not sure if it is correct.įor me Cpk should be used in my case, not Ppk since Ppk is used for process performance, not process capability if I am not mistaken. If I have understood correctly I and the team have to do SPC (calculating Cpk) for all Significant and Critical characteristics listed in SCCAF/ PFMEA/Control Plan ? is that correct ?Īnd another thing still not clear for me - For process crimping, terminal crimp height is SC, but it is quite difficult to do process capability (Cpk) on all terminals being used in production, so from one machine we must make 125 consecutive samples(crimped terminals) measure this characteristic, put the data in the software, set LSL and USL and check what is the variability. There's something that is not clear for me - what do you mean that I have to back up CC's with SPC of process parameters? can you clarify for me ? There are SC's for which the team will prepare Cpk and same for all CC's such as bolt tightening.
I do not know if you are still looking for ideas, but if you write down a list and share it then people could chip in.
#Cp im feeling curious software
If you are using statistical software it would be advisable it is a Ford-approved mainstream program, or that you have gone through the validation as per PPAP requirements page 8.Īs with any presentation, it will probably help you to prepare a list of topics to present. Ideally you will have prepared the measurements according to a rational sampling plan. If you plan to do SPC for these you must also backup them up with SPC of process parameters.ĭo not engage in an SPC presentation with Ford without the due 125 measuremets for the characteristic. Your organization must provide assurance to Ford you will not ship NOK product for these characteristics. If you check the links above, read through the process capability paragraphs. In case of CC's, remember SPC on its own is not enough. It will probably be more succinct to advise you at least on what NOT to say.
#Cp im feeling curious manual
The topic of SPC is wide and there is plenty of content to dig in the AIAG manual and The Cove discussions. Judging solely by our replies you probably have not gone too far.
0 kommentar(er)
