Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration


Instructor: Jose Mora
Product ID: 706942

  • Duration: 90 Min
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration. Does your DHF remediation process resemble the very mess that it is trying to resolve?
The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards. While it is retrospective in nature, it is the end result of a process that begins with planning and ends with Design Transfer and has the Device Master Record (DMR) as a deliverable.
Last Recorded Date: Jan-2024


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Read Frequently Asked Questions


Remediation is a retrospective reconstruction of that process. While one may be tempted to focus on the technical details of part and process specifications, one must not lose sight of the fact that remediation itself is a process.

Typical remediation practices are not managed as a process as one would understand the term. It has many fluid and moving decisions and ever-changing rules which are as good as the last meeting or the last conversation, not all of which are documented, not all of which every team member is privy to, and not all of which are communicated properly. Does this sound familiar? This webinar can help you!

A process has distinct inputs and outputs, distinct workstations, PARTS*** moving through it, distinct roles and responsibilities defined at each step, it has "traffic signals" and controls in place to make sure certain things have happened before those parts move on to the next step. It also involves resource allocation and movement to address bottlenecks. It means having the correct information and asking the right questions at the right time. Not tribal knowledge, nor dependent upon the memory of one person, no matter how experienced, intelligent, or talented that person may be. A swim lane diagram does not have parts, controls, and signals, or active bottleneck resource management. It does not have workstations, and it is not the living and moving thing that a process is.

A swim lane diagram is NOT a process. It is a map and depiction of the process flow, but it is NOT the process itself. Also, a tracker is not a process. It is at best a score board but not a substitute for the real thing.

This webinar deconstructs the DHF remediation process based upon lean manufacturing and documentation principles.

Why Should You Attend:

Which do YOU want to be? Only you can answer that. This webinar can show you how to be the latter:

Old school remediation: Lean and new school remediation:
Hire 50 consultants, tribal knowledge Process flow with signals
Put them to work on a PUSH system Pull system and Kanbans
Build mountains of work-in-progress Constraint management
Bury your information in folders Focus on process flow and output
Spend endless hours on rework Learn from initial successes
Flood customer resources to review Involve reviewers as part of flow
Endless trackers to track trackers Automatic information flow and tracking
Busy work with huge expenses Productive work with successful output
Focusing on numbers not actual results

Areas Covered in the Webinar:

  • Part 1 - Success begins with proper discovery
    • Examining documents, work instructions, specifications, process controls, BOMs, routers, etc.
    • Elements of lean documents and lean configuration and their role

    • Interviewing customer and supplier with first-hand knowledge,
    • Examining physical parts, and the process that created those parts
  • Part 2 - The Design History File (DHF) Remediation Process
    • Inputs, Outputs, workstations, moving parts
    • Signals, Kanban, pull system

    • Flow diagram
    • Process Constraints
    • RACI - responsible, accountable, consulted and informed

  • Part 3 - Management of / Access to / Accuracy of / Relevance of / Information
    • Product information
    • Process information
    • Supplier information
    • Risk information

    • Fixed information
    • Variable information
    • Flow of information

  • Management responsibilities
  • Qualification of personnel
  • Risk management plan
  • Risk management file
  • Bringing it all together – links to design and process

Who Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Research and Development Departments
  • Compliance Departments
  • Production Departments
  • Documentation Departments
  • Operations Departments
  • Medical Device Software Engineers
  • Medical Device Software Validation Departments
  • Medical Device Software Compliance Engineers
  • Document Control Teams
Instructor Profile:
Jose Mora

Jose Mora
Principal Consultant, Atzari Enterprises

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.

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