Using Kanban/JIT Systems and Lean Elements to Run a Startup Plant
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 the 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.
A medical device or biotechnology startup plant needs to have products available yet be agile enough to respond quickly to demand and design changes without wasting excess inventory, especially from obsolete products that did not pan out. This webinar explains how to set up and use kanbans all the way from Purchasing and Procurement, to Receiving, Receiving Inspection, Component Stock, Work Order Picking/Staging, Assembly, Packaging, Finished Goods, and Sterilization. Combining the principles of a Visual Workplace with Kanban bins and cards, this webinar will demonstrate step-by-step how to create a demand-pull system to achieve the right balance of inventory and throughput throughout your startup operation. The speaker will speak from personal experience, having been a Director of Manufacturing at a start-up operation. The "hands-on" use of Drum-Buffer-Rope from Theory of Constraints (TOC) will also be covered.
Also, lean cannot be just about product and process. This webinar also touches on the elements of lean documents and lean configuration, since the principles of lean must permeate throughout all systems, not just the manufacturing supply chain.
- Working definitions of kanban, JIT, pull system, and drum-buffer-rope, with emphasis on medical device and biotechnology manufacturing
- Introduction to the elements of lean documents and lean configuration
- Selection of appropriate sterilization lot size - a key factor
- Practical lot sizes for start-up medical devices
- How to handle large-volume and offshore suppliers?
- How MRP II can help - and hinder - an effective kanban system?
- How to use kanbans to track off-site sterilization services?
- Using kanbans with external supply chain suppliers
- Smart ways to minimize lot picking times
- Lot picking inside a cleanroom
What Will Students Learn
- Myths about lot size and local efficiencies
- Myths about documentation and support systems
- An alternative way to track yield losses during product builds
- Preparing kanban cards and bins to control both in-house inventory and external supplier inventory
- Smart ways to track variable information using kanban cards (example lot number, PO number, WO number, due dates)
- How to use kanbans for R&D prototype work?
- How to simplify paperwork to allow smaller lot sizes?
- Smart ways to simplify Receiving verification
- How product shipments trigger new builds?
Course Level - Intermediate
Who Should Attend
- Project Leaders
- Functional Managers
- Manufacturing Engineers
- QA Managers
- Operations Managers
- Supply Chain Managers
- Purchasing Managers
- Design Engineers
- Design Assurance
Why Should You Attend
This webinar will provide valuable insights into operations managers, supply chain managers, purchasing managers, planners, manufacturing engineers, design engineers, and other operations.
A startup plant faces many challenges and options. Too often, the brainpower and focus are on the science and technology of the product. However, without agile systems from the earliest stages, the company may struggle for the wrong reasons as it tries to ramp up its manufacturing and quality systems.
This webinar is essential to introducing lean principles from the company’s earliest stages.