sbickley
10th June 2005, 12:00 PM
Forum Members:
I have a request for you (from left field of course) regarding the ISO 9001:2000 requirements and an audit situation I’ve run into. Let me set the stage:
We have a Test Engineering group who is tasked with developing and implementing functional tests for Printed Circuit Boards (PCB) that are developed by a separate engineering department. The PCB components are installed in our game devices, tested, and shipped. The PCB dev. group (Mechanical Eng.) is, of course, responsible for all of the requirements specified under Clause 7.3 of the standard, prior to the PCB(s) moving into the production environment. The tests being developed are strictly to test board functionality, ie are circuit paths working, is current flowing, etc. This group provides tests to our suppliers, who manufacture the boards and must test them prior to shipment AND our production lines who have to test other game features as they are installed.
I’m conflicted about where the Test Eng. department’s process falls within the standard. 7.3 deals with D & D of the product, but does that also apply to the development of a functional test of a component part of the product? I see the test, once developed, becoming an integral part of 7.5.1 during product build and verification. I personally feel that 7.3 does apply. However, all of us are struggling with the value of creating design review and verification records of any substance as they are of limited value for this process. Each engineer has their own process for designing a test, review notes would be generated, filed and forgotton – never to be used again.
They do track design and verification progress on a spreadsheet, with date indicators showing workflow progression from step to step. In your opinion, would this record suffice to meet the records requirement of the standard?
Let me know your thoughts…
I have a request for you (from left field of course) regarding the ISO 9001:2000 requirements and an audit situation I’ve run into. Let me set the stage:
We have a Test Engineering group who is tasked with developing and implementing functional tests for Printed Circuit Boards (PCB) that are developed by a separate engineering department. The PCB components are installed in our game devices, tested, and shipped. The PCB dev. group (Mechanical Eng.) is, of course, responsible for all of the requirements specified under Clause 7.3 of the standard, prior to the PCB(s) moving into the production environment. The tests being developed are strictly to test board functionality, ie are circuit paths working, is current flowing, etc. This group provides tests to our suppliers, who manufacture the boards and must test them prior to shipment AND our production lines who have to test other game features as they are installed.
I’m conflicted about where the Test Eng. department’s process falls within the standard. 7.3 deals with D & D of the product, but does that also apply to the development of a functional test of a component part of the product? I see the test, once developed, becoming an integral part of 7.5.1 during product build and verification. I personally feel that 7.3 does apply. However, all of us are struggling with the value of creating design review and verification records of any substance as they are of limited value for this process. Each engineer has their own process for designing a test, review notes would be generated, filed and forgotton – never to be used again.
They do track design and verification progress on a spreadsheet, with date indicators showing workflow progression from step to step. In your opinion, would this record suffice to meet the records requirement of the standard?
Let me know your thoughts…
