Is Reliability Growth instituted at this phase and is it measured by design review activities through the product development cycle?
Are Design FMEAs generated for the system, and component level designs and do they reflect all Special Characteristics (product and process) derived from product level Design FMEA?
Are Special Characteristics Lists utilized?
Are Actions followed up and are Process FMEAs updated to reflect actions taken?
Is a Mistake Proofing Strategy (Poke Yoke) utilized from FMEA output for Design and Process?
What Team makeup exists for DFMEA development?
Are surrogate problem solving results used in DFMEA development?
Is Warranty Data used for Failure Modes and Effects on DFMEAs?
Have Designs been optimized using Design for Manufacturing and Assembly (DFMA)?
Are Design Verification Plans established and do they reflect Design FMEA outputs for product level system, and component level designs as appropriate?
Have Design reviews been held at appropriate stages part of all levels of designs?
Is there a formal design review process with design items identified (check sheet)?
Are serviceability items included?
Are records maintained?
Are APQP Design Deliverables part of the design review process?
Are Prototype Control Plans utilized and do they reflect Special Characteristics derived from Design FMEAs?
Are tolerance studies and analyses performed at intersections of mating components prior to design sign-off, part of management design reviews/sign-offs, and based on manufacturing variability data?
Is GD&T developed based on customer need and process capability?
Do Engineering Drawings reflect Special Characteristics driven from Design FMEAs and GD&T requirements?
Are Engineering Drawings confirmed on Process FMEAs?
Are changes to Engineering Drawings and Specifications promptly communicated and properly documented to all affected areas and utilized Design FMEAs to determine change impacts?
Do Engineering, Material and Performance specifications include sample size, frequency and acceptance criteria and contain special characteristics relating to physical properties, performance, environmental handling, and storage of Materials?
Are new equipment, tooling, facility, gaging, and test equipment requirements identified from Design FMEAs and included in the project plan?
Is the Manufacturing Process Sequence finalized and includes Process Flow and Plant Scroll?
Are Process Descriptions available that include written description of the assembly process and instructions by workstations?
Are Potential Process Failure Modes identified with the use of Process FMEA’s at the product level, system, and component level designs?
Are high-risk failure modes identified by station and are lists available?
Are recommended Significant and Critical Characteristics from DFMEA failure modes on appropriate process steps?
Are Prototype Builds conducted that include components that have completed and passed all Design Verification Testing, were made from production intent processes and information on actions required to improve designs from builds?
Is Product level, System and/or Component Design Verification Testing conducted that includes test results that include Pass / Fail criteria and identification of any test Failures on Design FMEAs?
Have Test, Diagnostic, and Service Procedures been finalized?