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.
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|
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Principal Consultant, Atzari Enterprises
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.
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