Design and Development Planning

1 Design and Development Planning b) Design and Development Planning 

Changes I) Design Changes i) Design History File 

IdentHying user needs, regulatory requirements, applicable standards 

Design Development Experiments and trials to create a prototype device and supporting documentation 

Design Verification Testing of the prototype to see if it meets design input requirements 

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You should prepare a design and development plan for each new design and also for any modification of an existing design that radically changes the performance of the... 

Design and development plans need to identify the activities to be performed, who will perform them, and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. In addition there does need to be some narrative, as charts rarely convey everything required. 

Planning for all phases at once can be difficult, as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of four separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases. 

Your design and development plans may also need to be subdivided into plans for special aspects of the design, such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. 

The standard requires that the design and development plans describe or reference design and development activities. Hence where you need to produce separate plans they should be referenced in the overall plan so that you remain in control of all the activities. 

The standard requires that the design and development plans be updated as the design evolves. 

This requirement appears low down in the list of requirements and should ideally have been the first requirement that the standard addressed under design control. Until you have a design input you cannot carry out your design and development planning. 

Prepare procedures for the preparation and maintenance of design and development plans. 

During the design and development planning, the organization determines the following ... 

Independent review of method and content Were review points adequately defined in the design and development plan Were review methods or techniques specified Were review responsibilities and review criteria adequately defined Was adequate time provided for review ... 

Disposal plan Did the design and development plan consider potential problems associated with decommissioning, demolition, or disposal of the system at the end of the life cycle ... 

Fast action expedite cycle Were provisions made in the design and development plan to respond rapidly to priority requirements without compromising project integrity or safety ... 

The objective of this phase is to come up with a design and development plan that spans across all design control phases (i.e., from design input to design validation and design transfer). The design and development plan is also called the project plan in some organizations. 

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