INFORMATION

(Procedures, methods, forms, WHO participates in this

information, and so on.) process?
 QP-4 – design and  Engineering
development control manager
 Product design  Product
checklist development
engineers
 Customer
requirements related  Sales representatives
to product,  Quality engineers
packaging,  Production manager
quantities, and so
on.
 Product application OUTPUTS:
 Budget/timing  Product and raw material
requirements specifications
 Statutory and  Process flows
regulatory  Failure mode & effects analyses
requirements (FMEAs)
PROCESS:  Prints/drawings/BOMs
Design and  Process specification sheets
Development Control  Inspection requirements
 Verification and validation results
OWNER:  Tooling/fixture validation
Engineering Manager  Trial run results
 Design review meeting minutes

What METRICS are

With WHAT? (Machines,
maintained to determine
tools, parts, equipment,
process effectiveness?
hardware, software, and so
on.)  Conformance to
schedule
 CAD system
software and related  Conformance to cost
hardware requirements
 R&D test equipment  Verification/validati
on failures
 Pilot plant
equipment  Customer
complaints due to
product design
issues