7.3 Design and Development
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
220.127.116.11 Monitoring and Measurement of Manufacturing Process. 18.104.22.168 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.