Lean Techniques: The QC Lab can

Reduce Product Lead Times

Tom DeWit

Pzers quality control (QC) laboratory in

Puurs, Belgium, has been applying lean techniques to reduce the total throughput lead time
for products across the entire supply chain for
several years. In 2010, the QC laboratory met
an ambitious target to cut standard lead times.
Following that, the lab moved on to the new
Pzer global manufacturing initiative called
lean laboratory, which involves adopting new
ways of working and a deeper internal customer engagement to achieve realworld results.
The lab began its lean journey in 2007,
engaging in several agile manufacturing projects
and endtoend value stream assessments. In
2009, the lab set its sights on reducing lead times
by 25% for eight major products. In 2010,
having met that target, it looked to the next level
of quality improvement, the Pzer lean laboratory initiative. A global model, lean lab is
currently being rolled out across Pzers entire
manufacturing organization; the Puurs lab was
included in implementation at the rst 12 sites.

New Ways of Working

What has allowed the lab to set, meet, and reach
new improvement targets is a lean approach that
emphasizes broader colleague involvement and
Tom DeWit is manager, chemical laboratory, quality
operations, Pfizer Inc. in Puurs, Belgium; reach him at
tom.dewit@pfizer.com.
This article was previously published in December/January
2011 in Pharmaceutical Formulation & Quality.

Copyright 2011 John Wiley & Sons, Ltd.

engagement to establish a highly effective and

collaborative approach to problem solving. At
one time, for example, a project lead might have
said, I will determine how to improve results,
and I will have it all worked out for you to
implement tomorrow.
This method may have worked in that it
generated some degree of improvement, but it
did not always produce the optimum solution.
Because the decision was made without seeking
the insight of the colleagues charged with
improving results, it didnt have buyin from
the very individuals who would ultimately carry
out the process.
In 2009, the lab initiated a more collaborative,
leancentered process that focused on engaging
colleagues in the reduction of lead times from the
start. Through brainstorming sessions and kaizen
bursts, which focus activity on a particular
process in the value stream, the lab used dene,
measure, analyze, improve, and control methodology to analyze its value stream and identify
ways to improve existing processes. Other
activities included:
conducting an inventory of eight high
volume products, realizing that throughput
improvements for this group would apply
to the remaining products;
determining where tests involving these
highvolume products were performed
within its 13 chemical and microbiological
laboratories;

Qual Assur J 2011; 14, 7275

DOI: 10.1002/qaj.479

QC Lab can Reduce Product Lead Times

establishing baseline lead times using
historical data and identifying focus areas,
representative tests, products, and laboratory impact; and
engaging QC supervisors and analysts from
the various laboratories to map out the current
value stream and to identify areas of opportunity for developing the future state value
stream map.
The lean concept invites colleagues to give input
and bring forward ideas for consideration that
may challenge the usual way of working. Just
because a process has always been done a certain
way does not necessarily mean that is the best way.
As expected, the colleagues who perform the work
involved in carrying out a specic process, in this
case test analysis, have the greatest insight into
where, why, and how frequently they were able to
identify nonvalue added activities and their
resulting impact on process robustness.
For example, colleagues pointed out that test
results might wait up to two days before being
doublechecked, as required by an independent
analyst. Their suggestion: optimize the process to
enable doublechecking within 24 hours; this
waiting period was soon whittled down to
between 12 and 24 hours. They created a spaghetti
diagram that mapped the movement path within a
laboratory during the execution of a test (Figure1).
This visual evidence claried the amount of non
value added activity that existed, while making it
easy to see how colocating materials and
equipment needed for a particular test into one
area would minimize wasted movement and time.
In order to stick to this tighter time frame,
colleagues took on the responsibility of planning,
scheduling, and organizing their individual workows. In this way they operated as selfdirected
teams, fullling the promise of a previously
launched initiative. Analyst teams now operate as
if theyre running their own business; by scheduling
their work, colleagues know whats coming in and
are able to organize workow without the involvement of a supervisor. Daily huddles enable them to
discuss, review, and iron out any issues.
Achieving a 25% reduction in lead times
involved many changes to the value stream map
Copyright 2011 John Wiley & Sons, Ltd.

73

(see Figure 2). One area targeted for improvement was the creation of a continuous workow
to execute postanalysis tasks, such as calculations, data input into the laboratory information
management system, and doublechecking and
approval activities.
There were also many opportunities to eliminate extra approval steps and wait times. The
collective efforts of the laboratory teams not only
helped achieve the target, but also maintained an
ontime delivery rate to customers of greater than
90% for the eight products, which represent 60%
of all manufactured seminished lots.
This notable success could be considered the
harvesting of lowhanging fruit. Now the lab
teams are stepping up efforts as part of the Pzer
global manufacturing lean laboratory initiative.
Through a multiphase approach, the teams
expect to improve quality, productivity, and
effectiveness by looking at not only the value
stream but also the volume of products coming
into the lab in order to level the workow and use
standard work teams.
In cases with high predictability in the
incoming volume of work, the company applies
a lean technique called rhythm wheels, which
allows it to set a xed schedule for executing
certain tests such as weekly pH testing. The train
testing method is better suited to less predictable
incoming workloads, especially in cases in which
testing is dependent upon maximum capacity
being reached or approaching deadlines.
Because leveling the workow enables the
company to work with standard teams, it can
plan ahead more accurately for the time and
equipment needed to perform and analyze
the required tests. Embracing lean has also
yielded another signicant benet: increased
customer engagement and transparency. The
process is not yet entirely transparent, but the
company has made substantial progress toward
that goal.

Achieving Stretch Targets

Throughout 2010, the Puurs lab continued to
stretch its targets for reducing total throughput
Qual Assur J 2011; 14, 7275
DOI: 10.1002/qaj

74

T. DeWit

Figure 1. Spaghetti diagram

lead times. The labs overall goal for 2010, in
addition to reducing lead times for its initial
group of eight highvolume products, is to
achieve a similar reduction across 80% of all
the products and volume handled by Puurs QC.
Establishing a reduced time schedule for all
products is among its targets for 20112012.

Toward that end, the lab has established a

benchmark: to match or beat its sterility testing
lead time; 13 or 18 working days within a climate
controlled environment is typical, depending on
the particular sterile product. Once this goal is
accomplished, the lab can assure its customers of
results for any product within two weeks.

Figure 2. Lead time reduction

Copyright 2011 John Wiley & Sons, Ltd.

Qual Assur J 2011; 14, 7275

DOI: 10.1002/qaj

QC Lab can Reduce Product Lead Times

Another quality initiative focuses on those

troublesome testing processes that result in
atypical outcomes and lead to additional analyses
and followup QA investigations. Atypical outcomes may be caused by a number of factors,
including broken equipment, test methodology,
or awed sample preparation.
Regardless of their cause, the result of such
occurrences is always rework and the potential
for detailed and sometimes lengthy laboratory
investigations. The subsequent impact of such
delays affects customer service levels. Getting it
right the rst time, which optimizes processes,
achieves a smoother workow, and minimizes
outcomes that require QA investigations, is the
focus of this initiative.

Copyright 2011 John Wiley & Sons, Ltd.

75

The quality improvements accomplished

to date, like those the lab is working toward,
require a new and different mindset and collaborative approach to problem solving. The most
important element is the early engagement of
key colleagues involved in the process, giving
them both responsibility and accountability
for making improvements that support overall
lab objectives.
These lean efforts incorporate best practices
that are in place throughout Pzers global
manufacturing network. Reducing lead times
means nurturing a culture of continuous improvement that focuses on the customer and
advances the companys collective efforts in
quality, productivity, and effectiveness.

Qual Assur J 2011; 14, 7275

DOI: 10.1002/qaj