Folks,
Let's keep in mind that verification and validation are not the same. Certs of Conformance and inspection on plating thickness (verification activity)will not suffice (but might if the auditor is weak).
For instance, an inspector makes a measurement of plating thickness and finds that it meets PRODUCT specifications. Have the PROCESS specifications been maintained through the plating of the part? How would you know? Will the part flake due to poor surface preparation? Is plating thickness the same uniformaly especially in corners? What is the suppliers Preventive Maintenance program and how well do they monitor/maintain equipment, solutions in tanks, etc.? (I’ve emphasized PRODUCT and PROCESS to draw distinctions and not to shout at anyone)
Special Processes are those processes which inspection and test alone are insufficient to determine the acceptability of a part/good. It is necessary to understand how well designed a process is at meeting the design requirements of the part/component. Consider the inputs to producing a finished part/component/good: man, machine & equipment, material, methods, measures and environment. Validation examines the robustness of each of these areas in meeting the PROCESS specifications. Invariably, some means of test and inspection will need to be performed to confirm the process capability at meeting the PRODUCT specifications. Often times the inspection and test methods themselves are Special Processes requiring their own verification and VALIDATION. Validation challenges that the process designed to manufacture (plate) a good consistently produces product meeting PRODUCT specifications.
Keep in mind that verification and validation are both necessary. I’d like to also offer that Statistical Process Control is also a critical element in assuring product quality and conformity. SPC more so than SQC, perhaps, but both are important.
Good discussion folks! Back to the group…
Regards,
Kevin