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An Advanced Course on Lean Documents, Lean Configuration, and Document Control
- Definition of lean documents.
- Problems with traditional document approach.
- Applying lean manufacturing principles.
- Applying Theory of Constraints.
- Design History File.
- Device Master Record.
- Device History Record.
- Typical challenges and how to overcome them.
- Examples of various types of lean documents.
- Use of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.
- How the traditional document approach generates waste.
- Clues from Theory of Constraints and Lean Manufacturing.
- What a lean document approach would have.
- Creating a lean Design History File.
- Creating a lean Device Master Record.
- Creating a lean Device History Record.
- Preparing to configure an electronic document system.
Overview of the webinar
In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.
Who should attend?
- Manufacturing Engineers
- Design Assurance
- Document Control
- Operations
- Project Leaders
- Quality Assurance
- R&D
Why should you attend?
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems that cause significant operating expenses and make it difficult to introduce process improvements in a timely manner.
This webinar presents key concepts for introducing lean principles while maintaining a state of control and regulatory compliance. It will help you understand applying lean manufacturing principles, the theory of constraints, DHF, DMR, and DHR, and how to create a lean DHF, DMR, and DHR.
Faculty - Mr.José 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.
Jose´ worked for 10 years at Cordis Corporation 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, 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 the fourth place.
By introducing world-class techniques, the Guiding Catheter design and manufacturing were 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.