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
| Solution- 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
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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
| Outcome- 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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