During a recent internal audit, one of our supervisors complained that they were not receiving enough assembly instruction documentation from the engineers on new products. I identified this as a noncompliance and issued
an Opportunity Report (corrective action report) as required by our procedures. I identified our company President as the person responsible
for correcting this noncompliance since he is also the supervisor over the engineers. I received (in essence) the following response to the Opportunity Report:
"When this happens, it is usually the result of an urgent request for delivery from a customer or prospective customer. If we know how to do what
the customer is requesting, it involves the use of existing products, and we have the products, we will never tell the customer we cannot meet their delivery requirement, because they have not allowed sufficient time for us to prepare our manufacturing documentation." He stated that we are really just reconfiguring one of our standard products to meet another customer's requirements. He has instructed me to review our process to see how it can be modified so that we can speed up the prototype development and delivery process. He wants to be able to "generate a Bill of Material based upon the components that the customer wants included in their "system", provide that and a "brief" set of instructions, with little or no documentation, to the shop floor supervisor and the purchasing agent to get the process moving." By this, he means bypassing
all design activity planning and documentation and then creating the shop assembly instructions and drawings once the prototype has been delivered to the customer (whenever the activity concerns a "reconfigured" product).
Reconfiguration = Taking an already designed product, making changes to the makeup of that product (might be software or firmware or hardware changes), and issuing it a new part number.
Okay, here is the problem. I say these changes, this "reconfiguration" is actually design activity and our design procedures should be followed, including the documentation of the design plan or reconfiguration plan and verifications and validations, and all else. He feels that this activity does not fall under
the requirements of design and development and that his earlier suggestions should be acceptable, that I just need to change the procedures to reflect this. Can you clarify whether this "reconfiguration" activity falls under the requirements for design and development?
hershal 11/21/2003
I strongly suggest that you consult with the Metrologist at an accredited calibration lab. That may seem like a cop-out, but the Metrologist will come in and look at your application and set-up, and be able to provide an on-the-spot opinion.
Hope this helps.
Hershal