Design and Development Process

Design and Development Overview

A systematic approach to transforming requirements into detailed product or service specifications while ensuring quality, reliability, and customer satisfaction throughout the development lifecycle.

Input Requirements

  • Customer needs
  • Regulatory requirements
  • Technical specifications
  • Industry standards
  • Previous designs

Resource Needs

  • Technical expertise
  • Design tools
  • Testing facilities
  • Prototype capabilities
  • Documentation systems

Control Measures

  • Design reviews
  • Verification steps
  • Validation methods
  • Change control
  • Documentation control

Design and Development Process

Planning Phase

  • Define objectives
  • Establish timeline
  • Allocate resources
  • Define responsibilities

Input Definition

  • Gather requirements
  • Analyze specifications
  • Review standards
  • Document constraints

Design Development

  • Conceptual design
  • Detailed design
  • Design reviews
  • Documentation

Verification

  • Design analysis
  • Testing protocols
  • Review meetings
  • Documentation check

Validation

  • Prototype testing
  • Performance evaluation
  • User acceptance
  • Compliance check

Design Review Points

Preliminary Review

  • Concept evaluation
  • Feasibility check
  • Resource assessment
  • Risk identification

Critical Design Review

  • Detailed analysis
  • Technical review
  • Standards compliance
  • Design validation

Final Design Review

  • Complete verification
  • Documentation check
  • Approval process
  • Release preparation

Validation Methods

Testing Methods

  • Prototype testing
  • Performance testing
  • Reliability testing
  • Safety testing

Analysis Methods

  • Simulation analysis
  • Risk assessment
  • Cost analysis
  • Performance modeling

Review Methods

  • Peer reviews
  • Expert evaluation
  • Customer feedback
  • Compliance check

Documentation Requirements

Design Documents

  • Design specifications
  • Technical drawings
  • Calculations
  • Analysis reports

Control Documents

  • Review records
  • Change history
  • Approval records
  • Validation reports

Output Documents

  • Final specifications
  • Test reports
  • User documentation
  • Release notes