Case Study The fast track to success using Lean

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					CANEA Consulting Group

                  Case Study: The fast track to success using Lean Six Sigma

       The challenge:
       To further increase the high quality and decrease the delivery time of the
       validation documentation offered as a critical complement to
       GE Healthcare’s well renowned protein separation systems.

       The solution:
       A project delivery model that improves operations and facilitates interaction
       between all involved departments. The model offers a structured approach to
       order handling, production, distribution and support within Fast Trak, the
       validation documentation department.
           Case Study: The fast track to success using Lean Six Sigma

Background                             The challenges
GE Healthcare is one of the leading    To secure timely production of
global manufacturers of medical        high-class documents that comply
devices. Their protein separation      with the latest regulatory laws,
systems are well renowned all over     meet the clients’ specifications and
the world.                             follow the pace of product
                                       development at GE Healthcare,
The Fast Trak team at
                                       Fast Trak was looking for ways to
GE Healthcare produces and
distributes validation documents
that help their clients in the         •   increase the quality of the
pharmaceutical industry to validate        documents,
their systems and comply with
                                       •   facilitate information exchange
regulatory laws at a fraction of the
                                           between departments,
time that it would take them to
perform the validation in-house.       •   improve delivery accuracy and
                                       •   decrease delivery time.

                                       The methodology
                                       On the overall level, the project
                                       followed CANEAs project model for
                                       implementing process improvement.
                                       On a detailed level, an appropriate
                                       selection of tools from the Lean Six
                                       Sigma “standard” tool set was utilized
                                       throughout the project. The work
                                       included for instance, interviews
                                       (including internal customers and
                                       suppliers), process mapping, cause-
                                       effect analysis and a number of
                                       intense workshops.
                                       A thorough analysis of the order
                                       handling, production, distribution and
GE Healthcare had positive
                                       support of the validation
experiences from working with
                                       documentation was performed in order
CANEA Consulting Group in the
                                       to highlight areas of improvement.
past and contacted them as
GE Healthcare was beginning to         The work focused on identifying,
roll out a Lean Six Sigma initiative   analysing and developing solutions to
for their Swedish operations.          eliminate unnecessary lead-time and
                                       waste, while at the same time
                                       improving document quality.
              Case Study: The fast track to success using Lean Six Sigma

                                        “With this structured approach we
The solution                            are also able to reduce the lead
Based on the findings the               time of our deliveries, something
improvement team found that Fast        that is essential to our clients and
Trak would benefit highly from a        will serve as a competitive
distinct project delivery model.        advantage in the sales of our
                                        protein separations systems.”
The project delivery model serves
as a tool for all employees within
Fast Trak and their counterparts in     Next step
the departments of sales, system        The project delivery model shows
production, distribution and service,   that GE Healthcare can continue to
providing:                              improve operations and will serve
•   A clear project delivery process    as a best-practice example for the
                                        Lean Six Sigma initiatives that will
•   Concise checklists for all steps    be rolled out within the organization
    in the delivery process             in the coming years.
•   Broader interfaces and
    structured interaction with other
    involved departments
•   Improved instructions and
    templates for document
    production input
•   Distinct roles and
    responsibilities within Fast Trak
The project delivery model was
developed in close collaboration
with the Fast Trak team and other
involved departments in order to
improve Fast Trak operations,
while facilitating the overall
handling of customer orders, that
normally include both systems,
validation documentation and
                                        For further information regarding CANEAs
validation performance.                 services please contact us:,

The results
”This project delivery model will
enable us to further increase the
already very high quality of our
validation documentation.”

says Ann-Kristin Gellerbring,
Director of Fast Trak Regulatory &