Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Learn to apply lean document and lean configuration principles to design inputs, design outputs and traceability matrices so they meet 21 CFR 820 and ISO 13485 with less duplication.
Speaker
Jose Ignacio Mora
Medical device quality consultant · Atzari Consulting · 30+ years in medical devices
Overview
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 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.
What’s 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
Who should attend
What you get
About the speaker
Jose 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, José 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. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis' first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, Jose managed the Maintenance and Facilities Department, taking that operation to a level rated as "tops" by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose's leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches
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