1000938 Speaker Data Sheet

Speaker Data Sheet

3000038 Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

1. Background
2. Why should you attend/Description of the topic
3. Level: Advanced
4. Duration: 90 minutes
5. Areas Covered in the Session
6. Who will benefit
7. Target Companies

Bio of José Ignacio Mora

Background:

Does your Supplier Quality remediation process resemble the very mess that it is trying to resolve?

Receiving Inspection (RI) and First Article Inspection (FAI) may appear to be the beginning of the manufacturing process.In fact, they are the end deliverables of the Supplier Quality Management Process which feed into the manufacturing line. More precisely, they are the objective evidence that the correct parts were delivered.

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 supplier quality remediation process based upon lean manufacturing and documentation principles.

Why should you attend/Description of the topic:

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

Level-Adv/Int/Basic:

Intermediate

Duration:

90 minutes

Areas Covered in the Session:

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

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

Target Companies:

Medical device and combination product biotechnology devices

Target Audience: Design Engineers, Design Assurance, Quality Assurance

Instructor Profile:

Bio of José Ignacio Mora