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7.3 Design & Development Planning
7.3.1 Product design and development (d & d) planning
You must plan and control the design and development of product
During design and development planning, determine:
a)design and development stages
b)appropriate review, verification, and validation at each stage
c)responsibilities and authorities
Manage the interfaces between the different groups involved to ensure:
Þeffective communication
Þclear assignment of responsibility
Update the planning output as needed, as the design and development activity progresses
Note: Clause 7.3 applies to both product and manufacturing d & d and focuses on error prevention rather than detection
Key Explanation Points and Tips:
ÞYou must include product design and development in your QMS scope if you contract or convey the perception that you design product, regardless whether you buy, outsource or actually do design and development.
ÞThe scope of your d & d activity must consider all aspects of the product and product realization processes to ensure its conformity to requirements. This includes product identification, handling, packaging, storage and protection during internal processing and delivery to the customer.
ÞProduct d & d sometimes results in new manufacturing processes or changes to existing manufacturing processes. This clause is equally applicable for designing and developing manufacturing processes.
ÞProduct design and development planning must focus on error prevention rather than detection in product quality as well as product realization processes.
ÞYou must have an overall plan for your design project. Your plan must specify the design and development stages, activities and tasks; responsibilities; timeline and resources; specific tests, validations, and reviews; and outcomes. There are many tools available for planning ranging from a simple checklist to complex software.
ÞThe degree and details of planning may vary according to size and length of contract or project, complexity, risk, product life, customer and regulatory requirements, past experience with similar product, etc. You have flexibility in determining the scope of the stages, review, verification and validation required for your product d & d projects.
ÞYour plan must be dynamic and updated as requirements and circumstances change. You must track progress against your plan at regular intervals or project milestones and update the plan as activity progresses.
ÞYour d & d plan must include methods to communicate information, responsibilities, results, discussions, reviews and resources.
ÞYou must take a multi-disciplinary approach that includes as needed, other functions (besides design) such as quality, engineering, purchasing, sales, tooling, production, etc. Your plan must clearly identify these other functions and their specific role and responsibilities regarding the project. Consider including customer and supplier personnel at appropriate stages to do work and review results or progress.
