Design controls turn user requirements, the voice of the customer, into technical design inputs, which then form the design specification, or design output. Because design controls require tracing requirements backward and forward to show they are met, many companies end up keeping duplicate information across controlled documents, a major source of inconsistencies and errors.
This 90-minute webinar applies the Theory of Lean Documents and its corollary, the Theory of Lean Configuration, to these linked, cascading documents. You'll get a brief introduction to both theories, see how the Quality System Regulation (21 CFR Part 820) and ISO 13485 apply to design control documents, and learn how to bring design inputs, outputs and the traceability matrix together.
WHY SHOULD YOU ATTEND?
If creating and maintaining design inputs, design outputs and traceability matrices feels redundant and awkward, or your engineers spend more time on paperwork than on design and manufacturing, this session offers a different approach built on established principles and practices.
It suits managers, supervisors, directors and vice presidents in manufacturing engineering, design assurance, quality assurance, operations and document control.
AREA COVERED
- Introduction to lean documents and lean configuration
- Quality System Regulation (21 CFR Part 820) and ISO 13485 requirements for design control documents
- Design inputs and design outputs
- The traceability matrix
- Applying lean document and lean configuration principles to these documents
- Bringing it all together
LEARNING OBJECTIVES
- Explain the principles of lean documents and lean configuration
- Apply 21 CFR Part 820 and ISO 13485 to design control documents
- Trace design inputs to design outputs without duplicating information
- Structure a traceability matrix using lean principles
- Reduce inconsistencies and errors across linked design documents
WHO WILL BENEFIT?
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
If creating and maintaining design inputs, design outputs and traceability matrices feels redundant and awkward, or your engineers spend more time on paperwork than on design and manufacturing, this session offers a different approach built on established principles and practices.
It suits managers, supervisors, directors and vice presidents in manufacturing engineering, design assurance, quality assurance, operations and document control.
- Introduction to lean documents and lean configuration
- Quality System Regulation (21 CFR Part 820) and ISO 13485 requirements for design control documents
- Design inputs and design outputs
- The traceability matrix
- Applying lean document and lean configuration principles to these documents
- Bringing it all together
- Explain the principles of lean documents and lean configuration
- Apply 21 CFR Part 820 and ISO 13485 to design control documents
- Trace design inputs to design outputs without duplicating information
- Structure a traceability matrix using lean principles
- Reduce inconsistencies and errors across linked design documents
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control