Design Control - Management of Electronic CAD files

McQueenster

Starting to get Involved
#1
We were recently audited to BS9001;2015 which identified a deficiency in our control of Electronic CAD files, including approvals. I've thought the best way to approach this is to create a stand-alone document which covers the specific implementation of CAD and how the workflows are implemented as well as where the design files are stored. The advantage of this is that if we move to another CAD package in the future then only one document is affected.

Does anyone have a sample document they can share that has been created to specifically control CAD design files to meet BS9001? The CAD software we are currently using is Altium.
 
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McQueenster

Starting to get Involved
#4
What was the nonconformity?
The non conformity was that there wasn't sufficient controls in place to trace the checking and approval of designs. Altium provides workflow that can manage this at both a component and system design level. I am considering taking those workflows and formalising them in a CAD control document.
 

McQueenster

Starting to get Involved
#5
A separate procedure may ignore the controls already in your Altium software:

ISO 13485 Compliance: Tools for PCB Designers and Manufacturers

Asking Altium users how they demonstrate conformity may reveal how to deal more effectively with your auditor.
Thank you for the link. What I have found is that the Altium workflows are configurable and can be set up to meet internal business process. There are default Altium workflows which I may adopt, and document, for my 'company standard' to demonstrate control
 

John Broomfield

Staff member
Super Moderator
#7
There are default Altium workflows which I may adopt, and document, for my 'company standard' to demonstrate control
Being as Altium is part your system, and it includes documented workflows as part of your management system, this should be sufficient for effective planning, operation and control.

Or did your auditor cite evidence to the contrary?
 

Jean_B

Trusted Information Resource
#8
Being as Altium is part your system, and it includes documented workflows as part of your management system, this should be sufficient for effective planning, operation and control.

Or did your auditor cite evidence to the contrary?
To add nuance: sufficient if authenticity of the (electronic) approvals is guaranteed through validation. Which becomes "prove it (someone else authorizing as if they were an appropriate person) cannot reasonably be done, to the degree that unauthorized designs cannot or clearly should not be used".
 

McQueenster

Starting to get Involved
#10
Being as Altium is part your system, and it includes documented workflows as part of your management system, this should be sufficient for effective planning, operation and control.

Or did your auditor cite evidence to the contrary?
Thank you for your reply. I have documented some of the auditor comments below

The auditor highlighted:
1. The choice of appropriate responsible person for checking and sign-off was not controlled as it was an informal arrangement
2. The approval/release process (workflow) was selectable by the Altium designer and therefore inconsistent rules being applied
3. Version control was not being applied to printable output meaning that the current schematic could not be identified from previous versions
4. CAD design schematic templates contained inconsistent information as each designer has a template preference.

These as all variables I think a CAD control document needs to capture.
 
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