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This is meant to give you a basic idea of the intention / requirements. A detailed discussion is presented in Clause_Interp_and_Upgrading.doc.

7.3.4 Design and Development Review
NOTE: There are no new requirements in Design and Development Review from the 1994 version.

Also see: 7.3.1 and 4.2.4

This is where a lot of companies fall down. During the design and development review process you need to pause to check that everything is on track, you can still fulfill requirements, and identify problems to get them out of the way (think feasibility). This is normally done on a regular basis on large-scale projects (say weekly). In the manufacturing world it takes discipline to do this. It is rarely done enough in the world of services. This revision of ISO 9001 will make it more difficult for service industries to avoid addressing the design of their services.

Potential Audit Question

1. Does your company perform a regular design review meeting during the design and development process? Please give a detailed description of how you conduct your design review meetings.

	The Deming PDCA Cycle	QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation

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