ISO 9001, Q10 Pharma Quality System Standard,  and the other related industry specific Quality management system standards provide us “what” we have to do, not how we should do it.

Lean methodology offers us the tools and cultural elements of how we could structure our systems to greatly improve the effectiveness of our business management systems.

When asked, most Lean experts agree that one of the most difficult parts of “Lean” is sustaining the improvements that have been made.  And yet, an ISO Based Quality Management System (QMS) is all about an organization ensuring the “effective planning, operation, and control of its processes”.

By fully integrating Lean into the Quality Management System, an organization can develop and deploy a much more effective Business Process Management while reducing the waste that has been created in redundant systems.  It will also add life to a stale quality management system that is perhaps not driving continuous improvement, while adding sustainability to lean improvement efforts.

The concepts of Lean and waste management must also be used to reduce the amount of documentation within an organization’s Business Management System in order to make it more user-friendly and thus, more effective.

Why Should You Attend:

  1. Too much competition for attention and resources between department serving the same purposes to the organization.
  2. Excessive documentation and redundancies
  3. Lean improvements that don’t get sustained
  4. Excessive non-conformities due to multiple systems
  5. Waste

Areas Covered in the Session:

  1. Difficulties with Lean
  2. Difficulties with Quality Systems
  3. The Business Management System (BMS)
  4. What Lean Brings to the BMS
  5. What Quality Systems Brings to the BMS
  6. System Integration
  7. Culture and Business Practices
  8. Lean Tools Relationship to the Quality System

Learning Objectives:

  1. To see and understand the waste in multiple systems focused on process and system improvement.
  2. To learn how to integrate lean and quality systems into one overall business management system thereby extending the lean enterprise

Who Will Benefit:

  • VPs
  • Directors and Managers within Operations
  • Directors and Managers within Quality
  • Directors and Managers within Continuous Improvement
  • Directors and Managers within Lean, Six Sigma teams
  • Lean Experts
  • Kaizen Team Leaders
  • Quality System Management Representatives
  • Internal Auditors



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