Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Service

A

agodina

Can someone explain what part 7.5.2 (Validation of Processes for Production and Service Provision) of the standard is asking for? Better yet, can someone give an example of a special process and how they would address the requirements stated in sub-parts a through e of 7.5.2 using the context of their example? Any assistance is appreciated. Thanks.
 
G

galcantar

Re: Help Understanding Part 7.5.2 of Standard

we are manufacturing wiring harnesses for heavy construction equipment hiw it applied to us is the electrical test ( continuity) due to we can't check continuity on the wires assembly until at the end when we form and complete the harness assembly ... another example is we validate the forming board and the test program during 1st piece inspection when a final piece is made and after we check this piece meets all print/ specs requirements then we validate that the board - tets program was made correctly remember that ISO?TS manadtes to review the design, verify your process capability and validate that the part meet with all print/ specs requirements. I'll hope this can give you an idea..
 
A

agodina

Re: Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Serv

So: When writing the Quality Manual is it appropriate to list specific 'special processes' unique to your organization (unable to check continuity, for example) and then summarize how the output of this exact process is validated? Or can you speak in generalities about how all 'special processes' are approached?
 
G

galcantar

Re: Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Serv

it's up to you-- what we did is stablish these processes as a part of the Flow Chart, FMEA, Control Plan and we discribe them in detail using a specific work instructions
 
A

agodina

Re: Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Serv

Got it. Thanks for your help.
 

Big Jim

Admin
Re: Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Serv

So: When writing the Quality Manual is it appropriate to list specific 'special processes' unique to your organization (unable to check continuity, for example) and then summarize how the output of this exact process is validated? Or can you speak in generalities about how all 'special processes' are approached?

Yes, it would be appropriate. It is far from mandatory as there are only three things a quality must have (see 4.2.2), and this is not one of them.

For your consideration, some common "special processes" are welding, brazing, soldering, plating, and painting. Generally speaking, you can't tell the outcome of these processes from normal inspection.

Plating is an excellent example. Since normal inspection cannot tell you the outcome of plating, the plater follows a specification (recipe). He then monitors that process. He checks the chemistry in the tanks as often as needed to confirm they are correct and keep records of that. Ofter, the temperature of the baths is critical, so that is also monitored and recorded. The length of time in the tank and the electrical settings are also important so they are also recorded. In the end, the plating shop ships you the plated parts with a certificate saying they have followed the recipe and have records to prove they did.

I hope that helps.
 
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