50 May 2014 • HEALTHCARE PuRCHAsing nEWs • www.hpnonline.com

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May 2014The self-study lesson on this central service topic was developed by STERIS. The lessons are administered by KSR Publishing, Inc.

Earn CEUsThe series can assist readers in maintaining their CS certifi cation. After careful study of the lesson, com-plete the examination at the end of this section. Mail the complete examination and scoring fee to Health-care Purchasing News for grading. We will notify you if you have a passing score of 70 percent or higher, and you will receive a certifi cate of completion within 30 days. Previous lessons are available on the Internet at www.hpnonline.com.

Certifi cationThe CBSPD (Certifi cation Board for Sterile Processing and Distribution) has pre-approved this in-service for one (1) contact hour for a period of fi ve (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-certifi cation is required. DO NOT SEND LESSON OR TEST TO CBSPD.

For additional information regarding certifi cation con-tact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ 08833 • www.sterileprocessing.org. For more infor-mation direct any questions to Healthcare Purchasing News (941) 927-9345, ext 202.

Learning Objectives1. Defi ne 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.

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Central 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 qual-ity management system, ISO 13485:2003, Section 8.1 states, “the department shall plan and implement the monitoring, mea-surement, analysis and improvement pro-cesses 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 specifi cations.

Indispensible quality toolsOver the years quality professionals have made use of seven basic tools of quality, fi rst emphasized by Kaoru Ishikawa, a profes-sor 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 specifi c requirements are identifi ed and controlled to prevent unin-tended delivery, they are taking necessary steps to ensure patient safety. These quality management tools provide a simple, yet

Quality tools help CS follow equipment and product specifi cationsby Richard Schule

strong, method for collecting, analyzing and visualizing information from various views.

More than internal quality controlThere 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 improve-ment; 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 specifi c procedures, work instruc-tions and meeting Customer specifi cations. The challenge for leadership is continu-ally maintaining a work environment that promotes success, achieves conforming product and supports professional growth. As a part of a successful quality manage-ment 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-

Quality Tool DescriptionCause-and-effect diagram

Identifi es many possible causes for an effect or problem, and sorts ideas into useful categories. Also known as the Ishikawa Diagram or Fishbone Diagram.

Check sheet 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.

Control charts Graphs used to study how a process changes over time.Histogram The most commonly used graph for showing frequency distributions, or how often

each different value in a set of data occurs.Pareto chart Shows on a bar graph which factors are more signifi cant.Scatter diagram Graphs pairs of numerical data, one variable on each axis, to look for a relationship.Stratifi cation A technique that separates data gathered from a variety of sources so that patterns can

be seen (some lists replace “stratifi cation” with “fl owchart” or “run chart”).

- Transcribed from www.asq.org 2/3/2014

www.hpnonline.com • HEALTHCARE PuRCHAsing nEWs • May 2014 51

Sponsored by sELf-sTudy sERiEsSelf-Study Test Answers: 1. D, 2. B, 3. D, 4. A , 5. D , 6. C , 7. C , 8. B, 9. E, 10. E

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 per-petual 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 sheetCheck sheets are a simple form used to collect or record the fre-quency 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 happen-

ing 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.

Creating a check sheet1. Decide what event or problem will be observed. Develop opera-

tional 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.

Check lists support quality processesChecklists, 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 qual-ity tools they will benefit by:

• Reducing defects.• Improving product quality.

Defect Types/ Event Occurrence

Nonconforming Events w/Loaner Orthopedic Trays – May 2013TotalSunday Monday Tuesday Wednesday Thursday Friday Saturday

Delivery <24 Hours 6

Missing Instruments 11

Wet Tray 2

Dirty Instruments 1

Instrument not Disassembled 1

Broken Instrument 0Missing Trials 0Pick Up >24 Hours 4

0 2 6 7 6 4 0 25Results collected from the Check Sheet for “Nonconforming Events w/Loaner Orthopedic Trays – May 2013”

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 il-lustrate and identify causes associated with these specific defects through

the use of the cause-and-effect diagram.

See Self-Study SerieS on page 52

sELf-sTudy sERiEs Sponsored by

• Ensuring quality improvement becomes the accepted environment.

• Increasing reliability.• Reducing costs by removing waste and

rework.• Identifying and establishing continuous

improvement techniques. • Conducting more effi cient 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 fi sh; doing so plans for the future and we all succeed through succession of our future leaders. HPn

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 expe-rienced clinical professionals and a portfolio of surgical and sterile pro-cessing continuing education and in-service programs for healthcare providers. He has extensive experience at stan-dardizing and rebuilding educational programs for sterile processing staff at hospitals to help them achieve national certifi cation. He has also assisted with the writing and implementation of equipment work instructions, department policies, procedures and guidelines support-ing 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 Con-trol and Epidemiology (APIC), the American Society for Qual-ity (ASQ), the Association of Surgical Technologists (AST), the Society of Gastroenterology Nurses and Associates (SGNA), and the International Association

of Healthcare Central Service Materiel Manage-ment (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 Improve-ment 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. McGraw-Hill New York NY 2010.

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Quality tools help CS follow equipment and product specifi cations

1. The seven basic quality tools include all except?A. Cause-and-effect diagramB. Check sheetC. Control chartsD. History lessonsE. Pareto chartF. Scatter diagramG. Stratifi cation

2. Checklists are the same as check sheets?A. TrueB. False

3. Another name for a defect concentration dia-gram is?A. Control chartB. Cause-and-effect diagramC. Scatter diagramD. Check sheet

4. Who is credited with developing the cause-and-effect diagram?A. Kaoru IshikawaB. Edward DemingC. Joseph JuranD. Walter Shewhart

5. When to use a check sheet?A. When data can be observed and collected repeat-

edly by the same personB. When collecting data on the frequency or patterns

of defectsC. When collecting data from a production processD. All the above

6. Creating a check sheet, how many defects can be tracked at one time?A. FiveB. EightC. TenD. Twelve

7. Which ISO document supports quality tools?A. ISO 14385B. ISO 12345C. ISO 13485 D. ISO 17665-3

8. Kaoru Ishikawa believed only quality professionals played a greater role in quality improvement?A. TrueB. False

9. Another name for the cause-and-effect diagram?A. Fishbone DiagramB. Pareto Diagram C. Root cause analysis D. Ishikawa DiagramE. Both A and D

10. What are the benefi ts when basic quality tools are implemented?A. Reduced defectsB. Improving product qualityC. Reducing costs by removing waste and reworkD. Ensuring q uality improvements become the ac-

cepted environmentE. All the above

Circle the one correct answer:

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