case studies

Case Study: Streamlining Design Controls


  • Division of 4 business units was struggling with the complexity of design controls.  The division had a set of requirements and corporate imposed another set of requirements.  This led to missing requirements due to hundreds of documents
  • Engineering was focused on compliance with Design Controls which became the product development process
  • A very diverse product mix with different design control requirements added more complexity


  • Redesigned the design control process, within the confines of  corporate requirements
  • Simplified, consolidated, and retired documents
  • Separated engineering practices from design control documents
  • Created a path for Class I and unclassified products to deliver to market

Why it Worked

  • Topics were reviewed with cross-functional groups to build buy-in with key stakeholders
  • Clearly defined handoffs between pre-design controls and design controls including how prototypes could be used
  • Addressed the biggest grievances:
    • Too many signatures
    • Document maze
    • DHF review process
    • Engineering design guidance documents treated as must do requirements


  • Only ~20% of the teams had to convert to the new system, yet ~80% chose to convert based on the improvements
  • Design reviews and design controls: Reduced the number of approvers from 110 to 45
  • Standardized signature titles across the organization: Reduced the number of different titles from 170 to 35
  • Quality system document word count: Reduced the number of words from 28,000 to 10,000
  • The number of product development Quality Management System (QMS) procedures dropped by ~45%

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Strategy 2 Market, Inc.



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