Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration
José 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. José 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, orthopedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José 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.
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents present a fresh departure from these practices while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.
- A brief introduction to Lean Documents and Lean Configuration
- Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHR
- Design History Files (DHF) content, development, and management
- Device Master Records (DMR) content, development, and management
- Device History Record (DHR) content, development, and management
- Applying lean principles to creating, developing, and managing a DHF
- Applying lean principles to creating, developing, and managing a DMR
- Applying lean principles to creating, developing, and managing DHRs
Course Level - Intermediate
Who Should Attend
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Document Control
Why Should You Attend
Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design? This webinar presents a fresh new approach based on solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.