Clause 7.3.1 Design and development planning

"Once you start a working on something, don't be afraid of failure and don't abandon it. People who work sincerely are the happiest."

Chanakya (Indian politician, strategist and writer, 350 BC-275 BC) 

It is as important for design and development activities to be controlled as it is for operations to be controlled. Design and development activities can be complex and it is not always easy to keep the timeline under control. While it is in no way the intent of the requirement to restrict the creativity of the designer, it is very important to ensure that the design and development process is controlled. Like any other operation, the type and extent of the design control should be dependent on the complexity of the design, and the number of the people involved. In some cases, design and development plans can be as simple as a short flowchart or checklist. In complex designs, sophisticated planning techniques are necessary.

The first step is to create a clear design and development plan. This plan should identify responsibilities/authorities and specific timelines. It should describe which groups or individuals are involved (for example: customers, subcontractors (suppliers), regulatory bodies, etc.) and how. It should also clearly identify the stage of the design process, including any checks and/or verifications for each stage.

It is not uncommon for conditions to change the design and development process. A design and development plan only has value if it is being updated when these change occur.

In 2008 edition, a note after the clause explains that design and development review, verification and validation have distinct purposes. They may be conducted and recorded separately or in any combination suitable for the product or the organization. This is merely a clarification as in many cases review; verification and validation are performed at the same time, for example engineering drawing preparation.

Planning shall determine:

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  design and development stages


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  review, verification and validation appropriate to each stage of design and development


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  responsibilities and authorities for development, review, verification and validation for each stage of design and development.

Design and development planning shall be updated as design and development progresses.

External Document Reference: Documentation Kit

Methodology for Product Design and Development
Design and Development Plan/Review Record