sELf-sTudy sERiE
May 2014
The self-study lesson on this central service topic was
developed by STERIS. The lessons are administered by
KSR Publishing, Inc.
Earn CEUs
The series can assist readers in maintaining their CS
certification. After careful study of the lesson, complete the examination at the end of this section. Mail
the complete examination and scoring fee to Healthcare Purchasing News for grading. We will notify you
if you have a passing score of 70 percent or higher,
and you will receive a certificate of completion within
30 days. Previous lessons are available on the Internet
at www.hpnonline.com.
Certification
The CBSPD (Certification Board for Sterile Processing
and Distribution) has pre-approved this in-service for
one (1) contact hour for a period of five (5) years from
the date of original publication. Successful completion
of the lesson and post test must be documented by
facility management and those records maintained
by the individual until re-certification is required. DO
NOT SEND LESSON OR TEST TO CBSPD.
For additional information regarding certification contact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ
08833 • www.sterileprocessing.org. For more information direct any questions to Healthcare Purchasing
News (941) 927-9345, ext 202.
Learning
Objectives
1. Define seven basic quality tools used
to collect and analyze data.
2. Describe various uses for the check
sheet.
3. Explain the key features for the
checklist.
Sponsored by:
sELf-sTudy sERiEs
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Quality tools help
CS follow equipment and
product specifications
by Richard Schule
C
entral service departments play a
greater role in total quality than ever
before, and ensuring our employees
are aware of the relevance and importance
of their activities and how they contribute to
the achievement of the quality objectives is
no small task. As a part of a successful quality management system, ISO 13485:2003,
Section 8.1 states, “the department shall
plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity to
product, to ensure conformity of the quality
management system and to maintain the
effectiveness of the same.” Incorporating
a few basic quality tools will allow central
service departments to track and record
their successes as well as opportunities to
improve staff performance and help to meet
equipment and product specifications.
Indispensible quality tools
Over the years quality professionals have
made use of seven basic tools of quality, first
emphasized by Kaoru Ishikawa, a professor of engineering at Tokyo University and
the father of “quality circles.” When the
central service department makes a vested
interest to ensure product or services that
do not conform to specific requirements are
identified and controlled to prevent unintended delivery, they are taking necessary
steps to ensure patient safety. These quality
management tools provide a simple, yet
Quality Tool
Cause-and-effect
diagram
Check sheet
strong, method for collecting, analyzing and
visualizing information from various views.
More than internal
quality control
There are many recognizable and respected
names in the quality circle, such as Edward
Deming, Joseph Juran and Kaoru Ishikawa.
Mr. Ishikawa believed that all employees
have a great role to play, arguing that an
over-reliance on the quality professional
would limit the potential for improvement; maintaining that a company-wide
participation was required from the top
management to the front-line staff and
every area of an organization can affect
quality. Central service staff and supporting
personnel are reminded through education,
training and competency the importance of
following specific procedures, work instructions and meeting Customer specifications.
The challenge for leadership is continually maintaining a work environment that
promotes success, achieves conforming
product and supports professional growth.
As a part of a successful quality management system, ISO 13485:2003, Section 6.3
states, “The organization shall determine,
provide, and maintain the infrastructure
needed to achieve conformity to product
requirements.”
Mr. Ishikawa wanted to change the way
people thought about work. He challenged
managers who were content to merely im-
- Transcribed from www.asq.org 2/3/2014
Description
Identifies many possible causes for an effect or problem, and sorts ideas into useful
categories. Also known as the Ishikawa Diagram or Fishbone Diagram.
Also called a defect concentration diagram; a structured, prepared form for collecting
and analyzing data; a generic tool that can be adapted for a wide variety of purposes.
Graphs used to study how a process changes over time.
Control charts
The most commonly used graph for showing frequency distributions, or how often
Histogram
each different value in a set of data occurs.
Shows on a bar graph which factors are more significant.
Pareto chart
Scatter diagram Graphs pairs of numerical data, one variable on each axis, to look for a relationship.
A technique that separates data gathered from a variety of sources so that patterns can
Stratification
be seen (some lists replace “stratification” with “flowchart” or “run chart”).
50 May 2014 • HEALTHCARE PuRCHAsing nEWs • www.hpnonline.com
sELf-sTudy sERiEs
Sponsored by
prove a product’s quality, instead insisting that continuous quality
improvement can always go one step further. He promoted the
concept of company-wide quality control that called for continued
Customer service. This level of service would extend throughout
the company, including all levels of management and indeed even
reaching into the everyday lives of those involved. Quality is perpetual motion and improvement of process through a systematic
method of audits and review. The check sheet is one tool that can
help to identify opportunities for process improvement.
When to use a check sheet
Check sheets are a simple form used to collect or record the frequency of occurrences for specific events during an identified
data collection period. Check sheets can be directly coupled to
histograms to provide a visualization of the data results. Check
sheets are particularly useful:
• When data can be observed and collected repeatedly by the same
person or at the same location.
• When there is a need to translate perceptions of what is happening into what is actually happening.
• When collecting data on the frequency or patterns of events,
problems, defects, defect location, defect causes, etc.
• When collecting data from a production process.
Check lists support quality processes
Checklists, not to be confused with check sheets, are an excellent
method for assuring specific requirements are followed. Some of
the key features of the checklist are quantity and/or measurement
of required specifications, parts, inventory or specific step in a
sequence of events leading up to the final product. Checklists can
be used for many functions:
• Daily preparation of work stations before starting or ending shift.
• Tray assembly, instrument count sheets.
• Case cart build, preference cards.
• Periodic audits of processes in SPD as well as other locations
throughout the health care facility.
ISO 13485:2003 supports the use of checklists as a method of
monitoring product specifications. Initiating a checklist prior to
starting shift work helps to ensure all accessories are present and
support efficient operation. Checklists also identify short falls
and opportunities to improve processes, training and reduction
of non-conforming products.
When the central service professional implements these basic quality tools they will benefit by:
• Reducing defects.
• Improving product quality.
See Self-Study SerieS on page 52
Creating a check sheet
1. Decide what event or problem will be observed. Develop operational definitions.
2. Decide when data will be collected and for how long.
3. Design the form. Set it up that data can be recorded simply by
making check marks.
4. Label all spaces on the form.
5. Test the check sheet for a short trial period to be sure it collects
the appropriate data and is easy to use.
6. Each time the targeted event or problem occurs, record data on
the check sheet.
Track up to 10 defects on each day of the week. The illustration
below shows a check sheet used to collect data on nonconforming
events with Loaner Orthopedic Trays for the month of May. The
check marks were added as data was collected over several weeks.
Data collected is presented at the monthly department leadership
and department staff meetings for discussion and subsequent
review of existing procedures and work instructions. The data
is also compared with the Corrective Action log as a check and
balance of the department’s Corrective Action/Preventive Action
(CAPA) policy.
Defect Types/
Event Occurrence
This visualization immediately allows us to focus our attention on missing
instruments as the number one defect for loaner orthopedic trays. Equally
remarkable are the delivery and pick-up times associated with these
loaners. Possible next steps would have the team assemble and further illustrate and identify causes associated with these specific defects through
the use of the cause-and-effect diagram.
Nonconforming Events w/Loaner Orthopedic Trays – May 2013
Sunday
Delivery <24 Hours
Missing Instruments
Wet Tray
Dirty Instruments
Instrument not Disassembled
Broken Instrument
Missing Trials
Pick Up >24 Hours
Monday

Tuesday





Wednesday
Thursday
Friday






0
2
6
7
Saturday

6
4
0
Total
6
11
2
1
1
0
0
4
25
Results collected from the Check Sheet for “Nonconforming Events w/Loaner Orthopedic Trays – May 2013”
Self-Study Test Answers: 1. D, 2. B, 3. D, 4. A , 5. D , 6. C , 7. C , 8. B, 9. E, 10. E
www.hpnonline.com • HEALTHCARE PuRCHAsing nEWs • May 2014 51
sELf-sTudy sERiEs
• Ensuring quality improvement becomes
the accepted environment.
• Increasing reliability.
• Reducing costs by removing waste and
rework.
• Identifying and establishing continuous
improvement techniques.
• Conducting more efficient and focused
meetings.
• Increasing Customer loyalty.
Quality management systems are no
longer luxuries reserved for large academic
healthcare campuses with deep resources.
Central service departments of all shapes
and sizes are increasingly moving toward
some variation of quality improvement
with a vision for implementing a QMS. It is
time to build your quality tool box and add
a few simple basic tools to assist your team’s
success. These tools are to be shared and
transparent. Through the eyes of Ishikawa,
all employees play a greater role in total
quality when taught to fish; doing so plans
for the future and we all succeed through
succession of our future leaders. HPn
Sponsored by
Richard Schule, MBA, BS,
CST, FAST, CRCST, CHMMC,
CIS, CHL, FCS, AGTS is the
Director of Clinical Education and
Co-chair of STERIS University at
STERIS Corporation. In this role,
he is responsible for a team of experienced clinical professionals and a
portfolio of surgical and sterile processing continuing education and
in-service programs for healthcare
providers. He has extensive experience at standardizing and rebuilding educational programs
for sterile processing staff at hospitals to help
them achieve national certification. He has also
assisted with the writing and implementation
of equipment work instructions, department
policies, procedures and guidelines supporting an ISO quality management system for
sterile processing. Schule holds a Bachelor of
Science degree in healthcare management from
Southern Illinois University and a Master of
Business Administration from the University
of Phoenix. He is a member of the Association
for the Advancement of Medical Instrumenta-
tion (AAMI), the Association for
periOperative Registered Nurses
(AORN), the Association for
Professionals in Infection Control and Epidemiology (APIC),
the American Society for Quality (ASQ), the Association of
Surgical Technologists (AST),
the Society of Gastroenterology
Nurses and Associates (SGNA),
and the International Association
of Healthcare Central Service Materiel Management (IAHCSMM).
References
1. ANSI/AAMI/ISO 14937:2009/(R) 2013. Sterilization of health
care products - General requirements for characterization of a
sterilizing agent and the development, validation and routine
control of a sterilization process for medical devices.
2. Bauer, J.E., Duffy, G.L., Westcott, R.T., - The Quality Improvement Handbook, 2nd Edition. ASQ Quality Press, Milwaukee, WI
2006.
3. International Standard ISO 13485 Medical devices – Quality
management systems – Requirements for regulatory purposes,
Second edition 2003-07-15
4. Juran, J. M., De Feo, J.A. – Juran’s Quality Handbook – The
Complete Guide to Performance Excellence, 6th Edition. McGrawHill New York NY 2010.
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Visit www.hpnonline.com/ce
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CONTINUING EDUCATION TEST • MAY 2014
Quality tools help CS follow
equipment and product specifications
Circle the one correct answer:
1. The seven basic quality tools include all except?
A. Cause-and-effect diagram
B. Check sheet
C. Control charts
D. History lessons
E. Pareto chart
F. Scatter diagram
G. Stratification
2. Checklists are the same as check sheets?
A. True
B. False
3. Another name for a defect concentration diagram is?
A. Control chart
B. Cause-and-effect diagram
C. Scatter diagram
D. Check sheet
4. Who is credited with developing the cause-andeffect diagram?
A. Kaoru Ishikawa
B. Edward Deming
C. Joseph Juran
D. Walter Shewhart
5. When to use a check sheet?
A. When data can be observed and collected repeatedly by the same person
B. When collecting data on the frequency or patterns
of defects
C. When collecting data from a production process
D. All the above
6. Creating a check sheet, how many defects can be
tracked at one time?
A. Five
B. Eight
C. Ten
D. Twelve
7. Which ISO document supports quality tools?
A. ISO 14385
B. ISO 12345
C. ISO 13485
D. ISO 17665-3
8. Kaoru Ishikawa believed only quality professionals
played a greater role in quality improvement?
A. True
B. False
9. Another name for the cause-and-effect diagram?
A. Fishbone Diagram
B. Pareto Diagram
C. Root cause analysis
D. Ishikawa Diagram
E. Both A and D
10. What are the benefits when basic quality tools
are implemented?
A. Reduced defects
B. Improving product quality
C. Reducing costs by removing waste and rework
D. Ensuring quality improvements become the accepted environment
E. All the above
CONTINUING EDUCATION TEST • MAY 2014
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