Re: Validation protocol for a crimped contact
These generally just recommend standard QA process controls (crimp height/tensile test/visual crimp attributes). What I need is an "OQ" and "PQ" protocol that defines sample size, methodology, etc. for the validation.
My thought at this point is to make it an attribute test with crimp height and tensile requirements. Essentially, we would have to run and OQ of a certain sample size at the upper and lower crimp height specs and use a minimum tensile strength as the pass/fail definition. I realize that both crimp height and tensile are variables data, but I would prefer not to have to deal with the assumtion of normal distribution for both of these. Making it an attribute type test allows me to define sample size based upon confidence limits and the number of defects allowed (we would use 0).