Applying Lean Documents to a Project - how to create a project file, follow design controls, yet maintain a lean set of project documents

This webinar explains the use of lean document principles and presents a step-by-step approach to creating a Design History File, a Device Master Record, and other key supporting documents. Typically, these records and their supporting documents contain many cross-references, duplicate information, and multi-functional documents which increase the chance of errors and other incorrect or imprecise information. Using the lean document approach, documents are written by the authors with the highest level of expertise, and information is presented in a simple, organized way.

Areas Covered in the seminar:

• Creating a Lean Discovery Phase Document
• Creating a Lean Definition Phase Document
• Creating a Lean Requirements Phase Documents
• Creating a Lean Design Phase Document
• Creating Lean Build Phase Documents
• Creating Lean Test Phase Documents
• Creating Lean Transition Phase Documents

What will students Learn:

• How to keep a Design History File lean
• How to keep Design History documents lean
• How to cross-reference while keeping duplication minimal
• How to avoid the use of "smart numbers"
• How to avoid unnecessary duplication of information
• Creating single-function documents

Who Will Benefit:

This webinar will provide valuable insights to design engineers, manufacturing engineers, operations managers, quality system managers, and document control managers

• Project leaders implementing an electronic document system
• Functional managers
• QA managers
• Lean Project Managers

Instructor Profile:

Jose Morap, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 24 years he has worked in the medical device 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. Jose worked for 10 years at Cordis Corporation, now a Johnson & Johnson 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 Ss (Visual Workplace), process validation to GHSS standards, and similar approaches.

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