Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration

The Design History File (DHF), Device Master Record (DMR) and Device History Record (DHR) are core building blocks for medical device design, manufacturing and cGMP compliance. Too often they become cluttered and confusing, and the way they are built and managed leads to errors.

This 60-minute DHF, DMR and DHR training applies the Theory of Lean Documents, and a matching Theory of Lean Configuration, to these records. You'll review what the Quality System Regulation, 21 CFR Part 820, expects of each, then see how to create, develop and manage each file using lean principles.

The result is an alternative to traditional methods that avoids many of their pitfalls.

• Explain the principles of lean documents and lean configuration
• Describe how 21 CFR Part 820 applies to the DHF, DMR and DHR
• Define the content of a DHF, DMR and DHR and how each is developed and managed
• Apply lean principles to reduce redundancy across these records
• Avoid common pitfalls of traditional medical device documentation

• A brief introduction to lean documents and lean configuration
• The Quality System Regulation, 21 CFR Part 820, as it applies to the DHF, DMR and DHR
• Design History File content, development and management
• Device Master Record content, development and management
• Device History Record content, development and management
• Applying lean principles to creating, developing and managing a DHF
• Applying lean principles to creating, developing and managing a DMR
• Applying lean principles to creating, developing and managing DHRs

If creating and maintaining DHFs, DMRs and DHRs is a constant struggle, with information repeated and chained together in awkward ways, this webinar offers a different approach based on solid principles and proven practice. It helps design and manufacturing teams spend less time on paperwork and more on engineering.

It suits R&D, manufacturing engineering, quality assurance, operations and document control staff.

• R&D
• Manufacturing Engineering
• Quality Assurance
• Operations
• Document Control

Jose 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. 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. 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, 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 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