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QC Lean Lab Whitepaper

The Quality Control Laboratory at Baxter's manufacturing facility in Germany implemented Lean techniques to reduce product release lead times. Key steps included training staff on Lean tools, establishing a Lean team, and applying the 6S methodology to organize the lab spaces. The lab also implemented Kanban systems for consumables and standards to prevent stock-outs. Process analysis using A3 reports and control charts identified opportunities to standardize high-volume product testing. Weekly A3 team meetings helped standardize information flow and prioritize critical analyses. A value stream map identified ways to eliminate corrections and establish testing priorities, resulting in up to 25% faster analysis times and synchronized chemical and microbiological testing. Overall, Lean implementation improved process understanding, commitment to improvement, and service

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Jeevanend Arumugam
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232 views

QC Lean Lab Whitepaper

The Quality Control Laboratory at Baxter's manufacturing facility in Germany implemented Lean techniques to reduce product release lead times. Key steps included training staff on Lean tools, establishing a Lean team, and applying the 6S methodology to organize the lab spaces. The lab also implemented Kanban systems for consumables and standards to prevent stock-outs. Process analysis using A3 reports and control charts identified opportunities to standardize high-volume product testing. Weekly A3 team meetings helped standardize information flow and prioritize critical analyses. A value stream map identified ways to eliminate corrections and establish testing priorities, resulting in up to 25% faster analysis times and synchronized chemical and microbiological testing. Overall, Lean implementation improved process understanding, commitment to improvement, and service

Uploaded by

Jeevanend Arumugam
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Implementing LEAN Techniques in

Quality Control
Optimizing and Leveraging
Improved Efficiency

Implementation of LEAN Techniques in


Baxters QC Laboratory
Applying LEAN techniques can result in
improved productivity, workflow efficiency
and cost savings. The Quality Control
Laboratory at Baxters contract
manufacturing facility in Halle/Westfalen,
Germany, has been applying LEAN
techniques since 2007 with the goal of
reducing release lead times. To achieve this
goal, several key steps were undertaken
and completed, as outlined throughout this
whitepaper.
Beginning the Journey: LEAN Training
Operators and other personnel at the facility
were trained on the major LEAN tools and
how to apply each. Next, a LEAN team was
built, consisting of colleagues from the
chemical and microbiological areas, to set
uniform standards in each lab area. The
initial focus of this team was to navigate
through the 6S procedure as a first
milestone.

result, this provided space for new


improvements or new orders.
For the second step, (Set in Order), the
individual analytical processes were
examined including consumables and
instruments, and were set in an order that
fulfills the required needs for the process,
space and ergonomics.
Next, all necessary requisites were cleaned
(Shine) after the reorganization. In this
context, the word cleaning stands for
purification on the one side and also for
putting things into a well maintained status.
The fourth step was to fix this status once
reached, (Standardize), so shadows were
used. This indicated clearly where things
belonged and ensured that a place was
identified for the item to be returned after
work was completed. Time-consuming
search activities were reduced as a result of
this measure.

6S, Kanban
The 6 Ss from the 6S cycle are
abbreviations for the following process
steps:
1. Sort Out
2. Set in Order
3. Shine
4. Standardize
5. Sustain
6. Safety
The first step was to Sort Out. All articles in
the laboratory which were no longer used
were removed at the beginning of the cycle.
Each was marked with a red dot and then
placed into a special dedicated area for a
period of three months before disposal. As a

Use of shadows in the QC lab

The sixth step, (Safety), is actually ongoing


throughout, with awareness of this goal built
into all activities. This is extremely important
for a lab which handles CMR (carcinogenic,

mutagenic and reprotoxic) substances and


affects, for example, the disposal of older
instruments.
This undertaking was driven both by the
European Baxter Lab Council (a group
focused on sharing best practices across
facilities), as well as by the manufacturing
facility. In regular 6S audits (Sustain) that
are performed by the lab supervisors, the
lab manager and black belts check the
status and make suggestions for future
improvements, helping to create an always
ready for an audit situation laboratory.
The implementation of Kanban systems for
consumables, as well as for reference
standards, was another milestone in
achieving the goal of reduced lead times.
These systems are visual indicators for the
material stock and ensured that these
materials were ordered early enough to
circumvent any out of stock situations. This
enhances the customer service level since
delays can be prevented.

After these necessary prerequisites were put


into place, a narrower look into the productspecific processes could begin.
A3 Technique, Control Charts
A Pareto analysis of all contract
manufacturing batches planned for the
corresponding year allowed the identification
of potential opportunities in the product
portfolio. The following criteria were taken
into account:

The number of batches produced


per material
The analysis times per batch
The number of operators involved in
the lab
The potential for standardization

Improvement projects for the identified


products were started thereafter. The
objective/goal and actual situation were
fixed on paper in an A3 format which
identified future measures. Corresponding
A3 teams were built. These teams included
members from all lab areas involved in the
analysis process, together with the
responsible lab supervisor and productmanager who possessed the productspecific knowledge.

2-Bin system for reference standards

Weekly A3 team session

These A3 teams met on a weekly basis.


Besides the release performance, the
product schedule, trends in analytics
regarding the product, events and special
information related to the production
schedule were discussed and solutions for
the future were agreed upon. Then, next
steps were fixed on Control Charts to be
followed up on in the next meeting.
This team approach revealed much deeper
process knowledge for all members and
emphasized the importance of broader
involvement and engagement. The flow of
information became more homogeneous
and trends occurring on the shop floor level
could be traced on a daily basis.

cases where deviations or OOS (out of


stock) results appeared, due to a newly
trained and dedicated taskforce.

This team approach revealed


much deeper process
knowledge for all members and
emphasized the importance of
broader involvement and
engagement

Based on the understanding of those


specific single processes, a more general
approach focusing on the total lead time was
a result.
Successful Reduction of Lead Time
A swim lane diagram including all functional
areas involved was created and discussed
to get an overview on the complex flow of
materials and documents that lead to
release approval. This was helpful to
understand how the different parts of the
lab, including chemical and microbial parts,
worked together, providing the insight to
allocate potential for eliminating late
corrections and establish information flow
and prioritization in such cases.
For the employees, it was important that
critical analysis first was a rule since it
affected service level to customers. Lead
times could be better guaranteed, even in

Based on this approach, the analysis time


for some products was reduced up to 25%
thus far. In addition, the former independent
releases in the chemical and microbiological
labs were synchronized, helping to ensure
all tests were completed on the date the
sterile testing was reviewed.

Overall, applying LEAN techniques


throughout the laboratory has led to a
deeper process understanding by all
involved employees, a demonstrated
commitment to continuous improvement,
and a direct, positive impact on our service
level to our clients due to decreased lead
time. This same approach is being
leveraged for application throughout the
facility and globally across Baxter QC
laboratories. Clients are taking note, too,
with one recently stating, I havent seen
such a well-organized QC lab before.

Term Glossary
LEAN A manufacturing/production system best characterized as relentlessly eliminating
waste from all of its activities and operations.
Kanban A Japanese term meaning visual record or card. In LEAN Manufacturing terms,
KanBan has come to mean Signal.
A3 The A3 problem-solving method and document, in combination with the value stream map
(VSM), both borrowed from practices of the Toyota Motor Company, have shown their value in
reducing waste and error. Why is the method called A3? In Europe, the nearest metric
equivalent to 11 x 17 paper is designated A3. The method confines a team to what will fit on
that size sheet of paper, forcing simplicity and quick communication. This assures the work can
be realistically completed within this constraint. It demonstrates successful change and
motivates workers to do even more problem solving. (excerpted from LEAN DIRECTIONS, the enewsletter of LEAN Manufacturing click here to read article in its entirety).

Pareto Analysis Pareto analysis is a statistical technique in decision making that is used for
selection of a limited number of tasks that produce significant overall effect. It uses the Pareto
principle the idea that by doing 20% of work, 80% of the advantage of doing the entire job can
be generated. Or in terms of quality improvement, a large majority of problems (80%) are
produced by a few key causes (20%).
Control Chart Monitors variance in a process over time and alerts the business to
unexpected variance which may cause defects.

Baxter is a registered trademark of Baxter International Inc. 920833-00 07/11

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