Case Study: Streamlining Design Controls

Issue

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

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%