Design controls are management practices such as policies, processes, and procedures that apply to control design activities. The goal is to control the design process in order to ensure that the system specifications meet the user needs and intended use.Design controls must be set up for a new product after the completion of the project-initiating phase and before the project-planning phase; that is, once it has been determined that the product is feasible and the decision to start the project has been taken. The real essence of design controls is to provide evidence that the system has been designed to be safe.

Chapter Contents:

• 17.1 Background
• 17.2 Design controls
• 17.3 Design control and development templates
• 17.3.1 Intended use template
• 17.3.2 Risk management file template
• 17.3.3 Software development plan template
• 17.3.4 Software requirements specification template
• 17.3.5 Software architectural design template
• 17.3.6 Software detailed design template
• 17.3.7 Test plan template
• 17.3.8 Test case specification template
• 17.3.9 Test procedure specification template
• 17.3.10 Test incident report template
• 17.3.11 Test summary report template
• 17.3.12 Review report template
• 17.3.13 Meeting report template

Inspec keywords: design engineering; production management

Other keywords: management practices; project-planning phase; design process; development management; design controls; design activities; system specifications

Subjects: Design; Production management