Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

Why Should You Attend:

• Do you find yourself constantly struggling to create, manage, and maintain all the information found in Corrective and Preventive Actions (CAPA) - which is often redundant, repetitive, and chained together in a cumbersome way?
• Do you find that your design and manufacturing resources are spending way too much time on documenting the CAPA process and not enough time on actually correcting and preventing systemic issues?

This webinar will present a fresh new approach based on solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional practices employed in preparing these documents.

Areas Covered in the Webinar:

• Brief introduction to lean documents and lean configuration
• Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to CAPA
• Alignment of the Six Sigma DMAIC approach to CAPA
• Applying lean principles to documenting and tracking non-conformances
• Applying lean principles to investigating and resolving non-conformances
• Applying lean principles to instituting corrective and preventive actions

Who Will Benefit:

• R&D Staff
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control
• Medical Device Managers
• Lean Program Leaders

Instructor Profile:

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, Mr. Mora 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 his time there, 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.

Mr. Mora 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. He 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, Mr. Mora 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. He 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 Mr. Mora’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.

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