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Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
- Brief introduction to Lean Documents and Lean Configuration
- Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
- Traceability Matrix
- Applying lean document and lean configuration principles to the above
- Bringing it all together
Overview of the webinar
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls require tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents. This repetition is a major source of inconsistencies and errors.
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents.
Who should attend?
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- R&D
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
Why should you attend?
- If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
- If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work. This webinar presents a new approach yet is based on solid principles and proven practices.
Faculty - Mr.Jose Mora
Jose Ignacio Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full-time as a consulting partner for Atzari Consulting, Jose´ served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem-solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
Jose´ led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace, and lean manufacturing practices.