Design Transfer Template capturing Customer Specific Requirements

D

Divyak

Registered
#1
#1
Source of the request: In one of the customer audit they wrote us finding for not documenting one of the customer specific requirement in the validation protocol in NPI phase and product was launched and it was in production from 1 year

So I have been tasked to create procedure/form to capture all customer specific requirements and process controls those need to be reviewed, objective evidence need to be provided and need to be confirmed by responsible personnel that all of them met requirements and it can move to production launch.

So I am confused that do I need to use design transfer form/Traceability matrix to do not repeat the same mistake

please give me your valuable ideas how can I finish the form/ send me templates if you have any

Thank you
 
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William55401

William55401

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#4
#4
Don't overthink this. A simple form with a customer requirements column and a how achieved column (that cites objective evidence) will do. I would imagine that as a contract manufacturer, your firm should be very good at PFMEA. The PFMEA tool is a good place to document customer specific process controls. Does your firm have a phase gate process to ensure readiness before starting manufacturing?
 
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