W
Ok so here is a tricky question...
Background:
Our company (9001:2008 & 13485:2003) builds capital equipment that is 'design & build' or 'build to print' with minor engineering adjustments as needed to correct customer drawings (with sign-offs). Every project & customer is unique and they span across several industries.
We exempt some parts from inspection process due to long-term experiences with the parts and supplier performance. Other parts, if problematic on repeat builds, we will of course inspect.
Recently inspection flagged a part as nonconforming because its two dowel-pin holes were +0.0004 out of tolerance. The project manager was notified, he reviewed the part and the specifications and made an informed decision based on experience with the product, the customer and his masters in engineering that the part would work and would not impact the function of the machine.
Our registrar audit was being conducted the same day and the instance was discovered, we were flagged a non-conformance for control of nonconfroming product as a result. The auditors logic is that we did not confirm the change in specification from the part's drawing (one of 800+) with the customer prior to approving it for use.
I understand the perspective of the auditor, however, it is our experience that this exact type of approval is what the customer doesn't want to be bothered with and that they hire us to address. Similarly, this customer (and many others) are slow to respond to drawing changes when we do submit them and as a result, one department in a customer organization can impact our delivery commitments to other business units in the customer organization.
How does everyone mitigate this? Surely others building custom machines do not have to get sign off for every (+,-) 0.00001 tolerance issue... do they?
We define "materials" as the items that contribute to the product (parts) and we define "product" as a machine that has passed all designated functional tests. We define "customer specifications" as the customer provided drawings and information needed to build the machine. Should we just redefine 'specifications' as the product dimensions and requirements specified in the proposal?
We have pulled a ton of benefits from the ISO standards and have a near flawless audit history with a very involved and committed management. if I can't resolve this nonconformance without having to petition customers for every ten-thousandth out may have to drop our certifications. Any suggestions for navigating some very murky water?
crossing my fingers for help...
:
Background:
Our company (9001:2008 & 13485:2003) builds capital equipment that is 'design & build' or 'build to print' with minor engineering adjustments as needed to correct customer drawings (with sign-offs). Every project & customer is unique and they span across several industries.
We exempt some parts from inspection process due to long-term experiences with the parts and supplier performance. Other parts, if problematic on repeat builds, we will of course inspect.
Recently inspection flagged a part as nonconforming because its two dowel-pin holes were +0.0004 out of tolerance. The project manager was notified, he reviewed the part and the specifications and made an informed decision based on experience with the product, the customer and his masters in engineering that the part would work and would not impact the function of the machine.
Our registrar audit was being conducted the same day and the instance was discovered, we were flagged a non-conformance for control of nonconfroming product as a result. The auditors logic is that we did not confirm the change in specification from the part's drawing (one of 800+) with the customer prior to approving it for use.
I understand the perspective of the auditor, however, it is our experience that this exact type of approval is what the customer doesn't want to be bothered with and that they hire us to address. Similarly, this customer (and many others) are slow to respond to drawing changes when we do submit them and as a result, one department in a customer organization can impact our delivery commitments to other business units in the customer organization.
How does everyone mitigate this? Surely others building custom machines do not have to get sign off for every (+,-) 0.00001 tolerance issue... do they?
We define "materials" as the items that contribute to the product (parts) and we define "product" as a machine that has passed all designated functional tests. We define "customer specifications" as the customer provided drawings and information needed to build the machine. Should we just redefine 'specifications' as the product dimensions and requirements specified in the proposal?
We have pulled a ton of benefits from the ISO standards and have a near flawless audit history with a very involved and committed management. if I can't resolve this nonconformance without having to petition customers for every ten-thousandth out may have to drop our certifications. Any suggestions for navigating some very murky water?
crossing my fingers for help...
