ComplianceOnline
Course "Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

The nature of documents that govern the design and manufacturing of medical devices are often redundant, repetitive, and cumbersome, and do not work well as a business process to properly support and realize the gains made in lean manufacturing. Design History Files (DHFs), Device Master Records (DMRs), and Device History Record (DHRs) are examples of three documents and files that are very closely related, yet create many problems and inconsistencies in their management, preparation, use, storage, and retrieval.

The information found in design input and design output traceability matrices often must be repeated in other documents in a way that creates the risk of errors or inconsistencies. These lead either to excessive non-value-added waste, or even worse, deficient products and processes. Medical device manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained in controlled records.

This highly interactive two day course on principles of lean documents and lean configuration will present a new approach that is based upon solid principles and proven practices. During this seminar, the theory of lean documents and its corollary applied to lean configuration will be used in order to construct, write, and configure the types of documents and records necessary for medical device design and manufacturing.



Learning Objectives:

Upon completing this course participants will:

  • Understand the fundamental principles of lean documents and lean configuration
  • Understand how to construct Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods
  • Understand how to construct a design input design output traceability matrix using lean documents and lean configuration methodologies
  • Be able to prepare a Quality Management System (QMS) for a medical device company using lean documents and lean configuration methods
  • Be able to prepare and manage a CAPA system using lean documents and lean configuration methods



Who Will Benefit:

This course is designed for people tasked with maintaining and improving 21 CFR 820 Quality Systems for medical device manufacturers. This includes individuals that have ISO 13485 Quality Management System responsibilities for making general improvements in their organization’s performance specifically related to Corrective and Preventive Actions (CAPA) as well as manufacturing operations. Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal Professionals



Topic Background:

The theory of lean documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents present a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.





Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  • Introduction and overview of the principles of lean documents and lean configuration
  • Overview of 21 CFR Part 820 and where the elements of lean documents and lean configuration may be applied
  • Detailed description and examples of elements for lean documents and lean configuration
  • Construction of a Design History File (DHF) using lean documents and lean configuration
  • Construction of a Device Master Record (DMR) using lean documents and lean configuration
  • Construction of a typical Device History Record (DHR) template using lean documents and lean configuration
  • Bringing the above together
  • Configuration of the above in an electronic system as an alternative to paper documents

  • Recap of lean documents and lean configuration elements
  • Construction of a design input design output traceability matrix using the principles and methods of lean documents and lean configuration
  • Typical documents used in manufacturing medical devices using lean documents and lean configuration methods
  • Examples of CAPA using lean documents and lean configuration methods
  • Creation of Quality Management System (QMS) Master Record and typical QMS documents using lean documents and lean configuration methods





Meet Your Instructor

Jose Mora
Biotechnology Consultant and Owner, Atzari Consulting, L.L.C.

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years Mr. Mora 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, Jose 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 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, 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.





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