Clause 7.3.4 Design and development review

Design and development review is a check to determine if the design and development activities are on track. More specifically, organizations need to verify if design is adequate in meeting the customer's and other requirements (design and development input).

For simple designs it may be sufficient to have only one design review at the very end of the design process. However, performing only one design review may be very risky for complex designs. If there are any problems identified as a result of design review, it may be very costly and in some cases too late to go back and redo some of the design activities in order to correct the problems.

The results of design reviews, including any problems that are identified and their solutions, must be recorded. This may be as simple as noting on the plan that the review has been carried out, as well as follow-up actions, signed off by the reviewer and dated. However, complex designs may be reviewed in a formal meeting, and the minutes of this meeting would constitute the design review record.

Design reviews can prevent problems at a later stage therefore all relevant parties should be involved. This may include internal departments as well as customers and suppliers (vendors).

Design and development review should:

• evaluate the ability of output (7.3.3) to meet input (7.3.2)
• identify problems (if any) and propose (solution) necessary action
  

Records (4.2.4) of design and development review and actions taken thereof shall be maintained.

External Document Reference: Documentation Kit

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