- Speaker : José Mora
- Session Code : JMJUL1322
- Date : 13th July 2022
- Time : This Event is Over and the Recorded Content is Available
- Duration : 1 Hour 30 Mins
An Advanced Course on Lean Documents, Lean Configuration, and Document Control
Overview:
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 if
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 which cause significant operating expenses
and make it difficult to introduce process improvements in a timely manner.
This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance. It will help you understand applying lean manufacturing principles, theory of constraints, DHF, DMR, DHR and how to create a lean DHF, DMR, DHR.
Areas Covered in the Session:
- 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 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.
Why should you attend?
In this 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 will benefit?
This webinar will provide valuable insights to
- Design engineers
- Manufacturing engineers
- Operations managers
- Quality system managers
- Document control managers
- Project leaders implementing an electronic
document system
- Functional managers
- QA managers
- Lean Project Managers
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, orthopaedic 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.
Enrollment Options
Tags: Advanced, Course, Lean Documents, Lean Configuration, Document Control, Jose Mora, July 2022, Webinar