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7.3 Design and Development

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The most significant change in 7.3 Design and Development is the exclusion of APQP and second most significant change is the inclusion of process design. The exclusion of APQP was on purpose. The APQP process will become a customer-specific document for GM, Ford and Daimler Chrysler. The inclusion of process design by the IATF is indeed significant. QS-9000-compliant organizations will need to carefully study the requirements of 7.3 for process design and make the necessary changes to their APQP process. The difficult challenge comes when the organization actually has to implement these changes. In some QS-9000 organizations, the process-engineering group is only one or two people.

When QS-9000 was released during late 1994, the payback to design-responsible organizations was a systematic design process. Many organizations went from chaotic product design to systematic design development. With ISO/TS 16949:2009 one of the paybacks will be a systematic manufacturing process design process.

What are the challenges for process design? Organizations will need to carefully create a design and development plan that includes all the phases of process design including - Manufacturing Process Design Input, Manufacturing Process Design Output, Design and Development Reviews, Monitoring of Process Design, Design and Development Verification and then Validation of the Manufacturing Process.

Organizations can decide whether to include Machine FMEA as a verification process and/or to include Machine Run off as a validation process. One of the opportunities is to build Mean Time to Repair (MTTR) and Mean Time to Failure (MTBF) into the process design. The other opportunity is to build in the entire methodology of Reliability and Maintainability (R&M). Leading edge organizations are already practicing this. Organizations interested in the up-front involvement of their tooling and equipment suppliers can look to the QS-9000/TE supplement requirements. They are guidelines and methodologies for machine FMEA, Machine Run off, Reliability, Maintainability, MTTR and MTBF for the entire life cycle of the manufacturing process.

Process design has been elevated to the same importance as product design. Now both design and process have the same type of expectations for inputs, outputs, verification and validation. Tools such as DFMEA, special characteristics, Design Verification Plan and Report (DVP&R) on the product design side and the tools such as process flow, PFMEA, Control Plans on the process design side need to be linked. This is the "effectiveness in practice" or the results that can be derived from implementing good product and process design practices.

Another requirement closely aligned with 7.3 Design and Development (process) is Monitoring and Measurement of Manufacturing Process. requires that all new processes be statistically studied as compared to PPAP which requires processes with only special characteristics are studied. Many organizations will implement this requirement as the last step of the Process Design and Development process.

The change in scope of 7.3 Design and Development toward including process design is an addition that will require both new documentation and then subsequent implementation. If implemented properly, this new requirement will result in profits for organizations.

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