Have Process FMEA’s been updated from Design phase activities?
Have Key Process Characteristics been finalized?
Are Actions followed up and are Process FMEAs updated to reflect actions taken?
Have Mistake Proofing requirements been updated for high-risk operations?
Are Supplier Product Development Plans and supporting documentation available and reviewed?
Are Special Characteristic Matrixes utilized?
Do matrixes identify Special Characteristic to Manufacturing Process operation relationships?
Are Pre-Launch Control Plans utilized and included specific additional actions/reactions, linkage to key Design and Process FMEAs and Process Flow charts, statistical evaluation of the process, reaction plans if problems are encountered in builds and Quality Assurance vs. Quality Control Methodology?
Are Product Level Predictive Indicators established and includes First Time Capability (FTC) vs Product Quality Assessments and FTC vs Warranty?
Have Tooling, Equipment, Gage, Fixture, and Test Equipment requirements been finalized and included comparison to key process characteristics and comparison to Control Plan to identify any new requirements?
Have Process Capability Estimates been finalized for each process characteristic?
Are reaction plan developed for each characteristic that does not meet capability targets?
Are Component Packaging and Shipping Design and Test Plans available and include packaging and shipping instruction, Shipping and Part identification label, Lab and Shipping Test requirements for expendable packaging and/or returnable containers, returnable container management program.
Have Operator Process Instructions been finalized and do they reflect FMEAs, Control Plan(s), Engineering requirements, Process Flow Chart, Floor Plan Layout, Characteristic Matrix, etc.?
Is Operator Training performed and are training plans available?
Are Pilot Builds conducted and include components from Hard Tooled processes and reviews that components meet design intent for Process Capability?
Is System and/or Component Production Validation Testing conducted and includes test results that include descriptive statistics, capability statistics and dentification of any test Failures on Design and Process FMEAs?
Are Supplier Process Sign-offs performed and include a procedure for Process Sign-offs offs and a systematic and sequential review of the manufacturing process at quoted peak daily line rate, including manpower, facilities, equipment, material, methods, procedures, etc.?
Are Potential Process Failure Modes identified with the use of Process FMEAs at the product level, system, and component level designs?
Are high-risk failure modes identified by station and are lists available?
Are Measurement Systems Analysis plans developed and do they include the responsibility for gage linearity, accuracy, repeatability, reproducibility, correlation for duplicate gages and measuring devices on manufacturing calibration systems?
Designation & Department