Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration


Instructor: Jose Mora
Product ID: 706777
Training Level: Intermediate

  • Duration: 90 Min
Based on lean manufacturing and documentation concepts, this webinar deconstructs the supplier quality remediation process.
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Why Should You Attend:

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.

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 Supplier Quality 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
  • Design Engineers
  • Design Assurance
  • Quality Assurance

From Pharmaceutical, Medical Devices, Biotechnology, Clinical Trial and Clinical Research Companies

Instructor Profile:
Jose Mora

Jose Mora
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.

Topic Background:

Following the implementation of the results of a Human Factors/Usability study, a validation of the safety and effectiveness of the use of the device must be conducted.

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