An Advanced Course on Lean Documents, Lean Configuration and Document Control 2019

Topics

• Problems with traditional document approach
• Definition of lean documents
• Applying Theory of Constraints
• Applying lean manufacturing principles
• Device Master Record
• Design History File
• Typical challenges and how to overcome them
• Device History Record
• Use of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents
• Examples of various types of lean documents
• Clues from Theory of Constraints and Lean Manufacturing
• How traditional document approach generates waste
• Creating a lean Design History File
• What a lean document approach would have
• Creating a lean Device History Record
• Creating a lean Device Master Record
• Preparing to configure an electronic document system

Who should Attend

• Functional managers
• Project leaders implementing an electronic document system
• Lean Project Managers
• QA managers