Making the Case for Quality
Critical Elements fo
Major Improvements
• The MEDRAD Critical
Elements improvement team
employed IMAGES®, the
company’s trademarked
continuous improvement
methodology, to focus
on processes in the
packaging area.
• The team reduced
expenses by $160,000
annually by using Six
Sigma and quality tools,
including
ainstorming
techniques and a
solution priority chart.
• The team also eliminated
excessive overtime
and the need to hire
temporary workers on
an annual basis.
At a Glance . . .
The MEDRAD packaging team worked 685 hours of overtime in 2007 and 443 hours in 2008. In
addition, two temporary employees were needed each year to keep up with the workload.
Overtime and expenditures on temporaries added up to a total of $40,000 in 2007 and 2008.
Many organizations face production problems such as excessive overtime at higher-than-normal labor
ates and a reliance on temporary workers. MEDRAD’s successful packaging area improvement
project shows what can be done to rein in these costs.
About MEDRAD
MEDRAD Inc., headquartered in Wa
endale, PA, designs and manufactures products used in medical
diagnostic imaging. Founded by a physician-entrepreneur in 1964, MEDRAD is now a business of
Bayer Medical Care, which acquired it in 2006. The company has approximately 1,700 employees and
offices in 17 nations.
Forty-two MEDRAD injector, pump, and coil products are readied for shipment in the 8,888-square-
foot packaging area, which is part of the Heilman Center, a 154,000-square-foot MEDRAD
manufacturing facility in Pittsburgh.
Injectors are delivery devices used to inject contrast dyes into patients undergoing CAT scans or MRI
procedures. Product names are Stellant, Provis, and Spectris Solaris EP. Pumps such as the Continuum
egulate the flow of dyes. Coils go over a patient’s head, neck, and shoulders and help to facilitate
scanning procedures. An example is the NVA-8 high-definition coil.
The packaging area is a first-shift operation where five assemblers called packaging clerks place
products in foam molds and deposit them in cartons. Literature such as operator instructions and
accessories are added; the box is then sealed and transfe
ed to the shipping area.
Why Quality?
In early Fe
uary 2009, Shawn Simpson, a process analyst and leader in the packaging area, was
concerned about the overtime and temporary employee costs and decided to take action. “I talked with
Lori Smith-Sakalousky, the manufacturing manager, to see if she would approve an improvement
project,” he said.
Her reaction was “very positive,” Simpson recalled. Simpson and Smith-Sakalousky felt that making
the packaging area more efficient would advance progress toward three corporate goals: improve qual-
ity and productivity, exceed the financials, and improve employee satisfaction.
y Ted Schaa
September 2010
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Getting Started
After writing a project charter to set expectations and goals, the
team created a solution priority chart and listed tasks on an
action log. The focus would be increasing the packaging area’s
ability to meet its objective without overtime or temporaries.
Team priorities were maintaining conformance to requirements
and improving productivity. Exceeding the baseline capacity of
500 units per month by 20 percent was a primary goal.
Simpson had read the book Toyota Culture, and the observation,
“Toyota trains employees like they are surgeons” stuck with him.
The Toyota approach calls for extensive classroom training and
a support staff that supplies the tools needed to be successful.
“There were similarities at MEDRAD,” Simpson said, “but I
didn’t feel like a surgeon when I went into the packaging area
at the Heilman Center. I felt like a scientist. It was a discovery
process. We were sitting down with managers and trying to
figure out how to improve the process, creating theories and test-
ing them. We were experimenting to find the critical elements
that lead to major improvements.” This is how the project name
Critical Elements originated.
Stakeholders
Nine kinds of internal stakeholders were identified as business
partners of the packaging team: multi-vendor service, service,
planning, shipping, procurement, plant management, perfor-
mance excellence center, the Finish Goods Area Optimization
Project, and manufacturing engineering.
The Finish Goods Area Optimization Project was another
improvement effort running parallel to Critical Elements.
The project team created a stakeholders analysis chart (Figure
1) to give each stakeholder a ranking and to create a method of
engagement. “We wanted to determine what areas and people
we would impact and rank them,” Simpson said, “So we met
with every group in the plant.”
Smith-Sakalousky a
anged for other process leaders to fill in
for Simpson as needed so he could manage the project. She also
apprised upper level managers and received their support.
Simpson credits his
ASQ membership
with helping him
learn about many
of the quality tools
and approaches he
used in the project:
“I’ve gained a great
deal from seeing
presentations at
ASQ conferences
and applied many
of the techniques I
ecame acquainted
with through ASQ
to build our project.”
He is also a Six Sigma Green Belt. “MEDRAD’s Six Sigma training
is called the Green Belt Wave,” Simpson said, “and it’s a combina-
tion of classroom and hands-on training.” Online coursework is taken
through MoreSteam University.
An earlier improvement effort had already produced major
changes to the packaging area.
“Before that project, employees specialized in packaging certain
products,” Simpson said. “It was determined that if everyone
was cross-trained, so all clerks could package any product,
efficiency would improve. It became more of a team effort.”
Assembling the Improvement Team
Simpson asked the five packaging clerks who work in the area to
join the improvement team along with two others.
Dominic Cicchirillo, an electromechanical engineer, was invited
for his track record in packaging. He is also a Six Sigma Black
Belt who has helped implement numerous improvements and
mentored others on how to use project tools.
Jeff Balog is a procurement supervisor who was chosen for his
procurement expertise and leadership skills.
“We have a limited amount of area and were trying to figure out
ways to free up space,” Simpson said. “Jeff understood what we
could do and what was off limits. For example, he knew what
items we needed to order in large quantities and store to get the
est pricing. We couldn’t do anything about those things. Jeff
helped us focus on things that we could change.”
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From left to right:
Mike Bann, packaging clerk
Jeff Balog, procurement superviso
Dominic Cicchirillo, electromechanical enginee
Ken Utiss, packaging clerk
Jim Vida, packaging clerk
Mark Suhanin, packaging clerk
Shawn Simpson, process analyst
Dave Yaksetich, packaging clerk
The Critical Elements Improvement Team
Figure 1— Stakeholders analysis
Stakeholde
Relationship to Project Priority
Method of
engagementIs affected
y outcome
Can
influence
outcome
Has
useful
expertise
Provides
esources
Has
decision
authority
Total Rank
Internal
MVS XXXXXXXXXXInform
Service XXXXXXXXXXInform
Planning XXXXXXXXXXAdviso
Shipping XXXXXXXXXXInform
Procurement XXXXXXXXXXTeam
Plant Management XXXXXXXXXXSponso
PEC XXXXXXXXXXSteering
FGA Optimization
Project XXXXXXXXXXInform
Mfg. Engineering XXXXXXXXXXTeam
Packaging Team XXXXXXXXXXTeam
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IMAGES® Continuous Improvement Methodology
The Critical Elements project team followed MEDRAD’s
trademarked continuous improvement methodology IMAGES®:
• Identify the problem
• Measure the cu
ent state
• Analyze the root causes
• Generate potential solutions
• Experiment and then Execute proven solutions
• Sustain improvements over time
“IMAGES was our foundation throughout the Critical Elements
project,” Simpson said.
Brainstorming to Identify the Problem
“I chose to have a
ainstorming session early to kick off the
project, because I thought it was important to understand the
voice of the customer,” Simpson explained. In this case, the
voice of the customer was the packaging team itself, so Simpson
says he posed a simple, boiled-down question: “What stops us
from packaging more units?”
The
ainstorming session led to the creation of the affinity
diagram shown in Figure 2. The team employed the Post-it® note
method and grouped waste into five categories: waiting, motion,
process, resources, and inventory.
“The affinity diagram was our road map to the measure and
analyze phase,” Simpson said. “All of the areas for improvement
were identified.” Stocking levels for magnetic resonance (MR)
products were analyzed first.
Measuring Process Waste and Analyzing Causes
Time studies were proposed as a means of analyzing process
steps and identifying waste. The team needed to quantify how
much time was spent obtaining parts, putting parts away, work-
ing on the computer, conducting necessary transactions, and
taking parts to storage locations in the shipping area.
“We package 42 different products, and I needed help,” Simpson
said. “Kennametal Center for Operational Excellence personnel
were conducting training at our plant, so I asked for resources to
complete the time studies. They provided interns.”
The interns observed employees like Jim Vida, a packaging clerk.
“Every morning I walked across the warehouse to the MR storage
location, which is 130 feet from the packaging area,” Vida said.
“I’d compare the quantities of each product against the stocking
levels and write the part numbers down on a priority list.”
Another example of waste the team identified involved the
Spectris Solaris EP battery, a high inventory item. “Through the
analyze phase, we found we were ca
ying 963 batteries. Our
safety stock level was 87 with a minimum order quantity of 200
pieces,” Simpson recalled.
One Spectris Solaris EP battery powers an injector and is shipped
with the product. It’s about as long as a laptop and five inches
high. Production and service demand inventory for the battery was
stored in the packaging area. The project team met with service
personnel to discuss the high inventory of EP batteries.
The service department was driving demand through the SAP
(systems applications and products in data processing) system,
ut it was not taking the parts on a monthly basis. This turned out
to be a major cause of the inefficiency the team was targeting.
Figure 3— SAP times compared to overall time
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Product Names
Ti
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Injector Times
24%
60
50
40
30
20
10
0
MR Times
35%
Process
Time Spent On
SAP
Backflushing
Final Root Cause – Need to align skill
sets within Electro-Mechanical Plant
SAP Time