Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration
Date : 07 February 2019
Time : 01 : 00 PM EST
Duration : 90 Minutes
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.
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.
Utilizing suppliers as an extension of an organization´s design and manufacturing capabilities presents unique challenges.
Many companies have outsourced both their design and manufacturing to specialized suppliers. As new medical device technologies push the boundaries of miniaturization, 3D printing and solid modeling, imaging, drug-device combinations, and new applications, the demand for specialized suppliers has left gaps in the common understanding of medical device requirements. Also, changes to ISO 13485:2016 have required a risk-based approach to all QMS processes – including those associated with supplier management and processes associated with them.
Supplier Quality Management presents the challenges of working through external parties to achieve internal organization objectives.
Overview of Supplier Quality Management
Review of Lean Documents and Lean Configuration concepts
- Basics of supplier quality management
- Issues around design controls and design freeze
- Issues around manufacturing and quality metrics
- Alignment of the supplier to designer/manufacturer
- Risk management including risk mitigation
- Risks around supplier quality during design changes
- Risk Management File and Design History File
- Lessons learned
Who Should Attend
Managers, Supervisors, Directors, and Vice-Presidents in the areas of
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Document Control
Why Should Attend
Changes in technologies and supply-chain arrangements have coincided with the expansion of regulations and standards to the entire supply chain. Unfortunately, many suppliers have not kept up or find themselves in a strange new world.
It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations and requirements.
Rather than wait to be surprised by unexpected situations, or to implement requirements haphazardly, it is better to understand what the hands-on challenges of dynamic cross-functional and cross-organizational teams as they push the boundaries of technology and new applications.
If you are already constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, and now realize a different way is needed, this webinar is something that will give you a different perspective and a very different approach that you can use.
This webinar is an overview of the coming changes and their implications, using a new approach yet is based on solid principles and proven practices.
- Speaker: JOSE IGNACIO MORA
- Webinar Code: JOMO-0011