Session Title:

Agile standards in a medical device production – a paradox?

Presented By:

Jens Christian Egholm Sørensen & Rasmus Jørgensen

Session Abstract:

A pilot project at the device production in the pharmaceutical company  Novo Nordisk – Device Manufacturing and Sourcing (DMS) resulted in a 30% reduction in SOP content, examples of a 80 % reduction in human related errors and increased employee engagement in SOP’s facilitated by clear Job Breakdowns (JB’s).

In 2010 DMS had little effective operational training material, SOP’s were heavy with text and difficult to transform into behavior, operational personal rarely suggested improvements and the SOP updating procedure were too time-costly to support agile continuous improvement.

This did not support the Director’s ambition about creating a “Best In Class” medical device production.

In his search for a solution he found the Training Within Industry (TWI) Job Instruction (JI) which was adopted as a principal part of the lean production system. Initially the biggest challenge was obvious – how to design a system that could handle an operational training document (JB), complement the SOPs and support compliance?

The TWI-JI training method was introduced in close collaboration between the operational training department and quality assurance to ensure agility, compliance and operational training effectiveness.

Session Objectives:

In this session you will learn from the Production Director, the Training Department Manager and the Internal Development Consultant about;

About the Facilitator:

Jens Christian Egholm Sørensen 

Technician with an degree in automation technics from TEC in Denmark specialized in medical devices and certified Project manager.

Associate manager at Novo Nordisk A/S. Responsible for Shopfloor Support which are 3 supporting teams for the production 1.Warehouse and internal flow. 2. Training TWI coordinators. 3. Environmental and health coordinators …

20 years at Novo Nordisk A/S, the last 10 years as manager with different tasks and teams such as pilot production, outsourcing to China and ramp up from pilot to high volume production

Rasmus Jørgensen 

Master of Science in production engineering from The Technical University of Denmark including internship at Toyota Motor Corp.

Lean consultant at Novo Nordisk A/S. Responsible for facilitating tactical improvement project portfolio, change management and implementing operational solutions (standardized work/TWI-JI, performance board meetings and structured problem solving).

The purpose for my work at Novo Nordisk A/S is to reach best-in-class performance level of medical device manufacturer by combining Appreciative Inquiry (AI) and Lean. Lean gives the structure and AI ensures engagement, creativity and passion.

Competences: Facilitation, workshop design, project management, change management, performance board meetings, problem solving and TWI-JI.