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.
Old school remediation:
Lean and new school remediation:
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
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
Course Provider
Jose Mora,
