Identifying Critical Items and Key Characteristics - Product Realization Process

wesleyjg

Registered
Dear all,

I have a question Critical Items. I hope you can help me to clarify it.

According to the CI definition:

Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including: safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed.

My company receives functional requirements from our customer, and we design and produce circuit board assemblies for full-time critical applications. When we conduct the FMEA, we must deep down up the component level.

Now we want to conduct the Special Requirements and Critical Items assessment and I do not know if we need to go as deep as the FMEA, or we should stop at board functional level.

I am not sure, but it doesn’t not seem to be much benefit in, later on, creating KC to control if COTS components specification (e.g. resistors, capacitors, and ICs) are within tolerances.

Thanks,

Wesley
 

APetersen

Starting to get Involved
Quick reply, normally just lurk but we are an OEM of radar systems and build our own PCBAs as well. One consideration is the evaluation of critical IC components that can be long lead time or are difficult to source. You may want to "require specific actions to ensure that they are adequately managed" based on their impact of the "safety, performacfe, form, fit, function, producivility, service life, etc"
 
Top Bottom