Practical Approaches to Lean in the Clinical Microbiology Laboratory Yellow Belt Certification

Transcription

1 Practical Approaches to Lean in the Clinical Microbiology Laboratory Yellow Belt Certification Joslyn Pribble, MS, MT(ASCP), CSSBB(ASQ) Microbiology Manager Methodist Health System, Dallas, Texas Susan Novak, PhD, D(ABMM) Director of Clinical Microbiology, Kaiser Permanente, California

2 Disclaimers Joslyn works in a laboratory that participates in pharmaceutical research and receives grants for such testing Joslyn is co founder of a laboratory occurrence tracking software program Joslyn is a member of the CAP s Laboratory Accreditation Program advisory committee None of these are relevant to this discussion and are not conflicts of interest

3 Objectives Define Lean Six Sigma (LSS) what it is and what it is not Discuss the 99.9% Problem and Higher Standards for Higher Performance Describe DMAIC LSS Improvement Process Discuss Organizing for Success and Working Relationships

4 Objectives (Continued) Quantify and Qualify Process Variability Define and Examine Common Tools Apply Lean Principles to real world situations

5 Control your own Destiny or somebody else will Jack Welch, Jack: Straight from the Gut

6 What is Lean? The core idea is to maximize customer value while minimizing waste. Simply, lean means creating more value for customers with fewer resources. Concept originated with Henry Ford but was brought into mainstream culture in 1990 by Toyota in Japan

7 What is Six Sigma? Six Sigma is a means to measure of quality that strives for near perfection. Six Sigma is a disciplined, data driven approach and methodology for eliminating defects. It was developed by Motorola in 1986 If there is a process involved, Six Sigma can be used

8 So what is Lean Six Sigma? LSS is: a set of techniques and tools for process improvement seeks to improve the quality of process outputs (product such as lab results) by identifying and removing the causes of defects (errors) and minimizing variability The concepts are used nearly interchangeably

9 Main concept centers around product and meeting customer s needs/expectations Failure to meet standards of end product (whether it be a manufactured car or a laboratory result) and not fulfilling customer s needs and wants is considered a defect or deviation from the normal. Each failure counts towards the sigma statistic

10

11 LSS process is deeply rooted in a methodology of hard work fused with a disciplines, factual, databased and statistical problem solving method

12 Employees are important assets to the success of the process and the company overall. Failure of administration to recognize this fact will result in failure of the LSS process. This process is a benefit for EVERYONE involved. If the company is successful overall, everyone gets to share in its success.

13 LSS Focuses on: Increasing quality, flexibility and timeliness in response to customer needs Promoting understanding of roles and responsibilities Maximizing staff responsibilities Developing internal continuous improvements capabilities

14 Reducing or eliminating wasted motion, space, supplies and under utilized equipment Expanding capacity by reducing costs shortening the cycle time Improving safety Creating a place for everything and putting everything in its place Utilizing staff skills sets for tasks appropriate to their training and education

15 What isn t LSS? A way to cut or eliminate staff A process to use when rapid, nearly instant change is necessary, especially when there is not time for group decision making Not a quick fix Should not be used unless there is commitment to evaluating the outcome and tweaking processes if necessary

16 Examples of Good LSS Projects Developing Physical Redesign of laboratory space Bringing in new testing methodology or instrumentation Changing workflow/schedules

17 When everything is a priority, nothing is a priority. Karen Mar n, The Outstanding Organization: Generate Business Results by Eliminating Chaos and Building the Foundation for Everyday Excellence

18 What is the belt system? Six Sigma training and certification levels are organized into a hierarchy of individuals names according to martial arts convention Belts are earned/awarded based on experience, various degrees of knowledge and skills gained in specific areas through training and experience

19 Belts (continued) An employee s belt level has nothing to do with their value to the company because for this process to work as intended, all levels are necessary Belts are independent of job title or formal education (college) background

20 Many companies have their own Six Sigma belt programs and can issue belts according to their own standards or guidelines either with or without required examinations. The most nationally recognized accredited agency for Six Sigma belts is the American Society for Quality (ASQ)

21 Additional Certification Agency International Association for Six Sigma Certification (IASSC) Traditionally recognized for companies operating outside of the USA although it is gaining popularity in the states. The exam is focused on international standards.

22 Belt Levels in LSS White (WB) Yellow (YB) Green (GB) Black (BB) Master Black (MBB) The beyond belts

23 White Belt Considered a controversial belt as it was created out of need for a less rigorous training course than the Yellow Belt Basic foundational understanding of LSS and its principles No prior project participation required Not fully recognized in the entire Six Sigma community

24 Yellow Belt Knowledge of how to integrate techniques of LSS, its metrics and basic improvement methodologies While possessing basic knowledge, this level does not lead projects on their own but would be responsible for the development of process maps to support projects

25 YB participates as a core team member of subject matter expert (SME) on a project Often responsible for running smaller process improvement projects using the PDCA (Plan Do Check Act) methodology This is traditionally seen as the most basic introduction level to the theories and practices of LSS

26 YB Training provides an introduction to process management and the basic tools of Six Sigma, giving employees a stronger understanding of processes, enabling each individual to provide meaningful assistance in achieving the organization's overall objectives.

27 Green Belt Level of training includes enhanced problemsolving skills with an emphasis on the DMAIC (Define Measure Analyze Improve and Control) model Does much of the legwork in gathering data and executing experiments Formal Greenbelt title requires passing an exam with a credentialing agency

28 Two primary tasks of GB Help successfully deploy LSS techniques Lead small scale improvement projects within their respective areas GB level people are spread throughout organizations and incorporate quality language and tools into their daily operation.

29 Black Belt Has thorough knowledge of LSS philosophies and principals including supporting systems and tools Exhibits team leadership, understands team dynamics and assigns their members with roles and responsibilities Primary role is to function as a change agent and project execution

30 Master Black Belt BB with additional training and experience. Must have gained experience by managing several projects and having a deep expertise and knowledge base in the tools and methods of Six Sigma Responsibilities are mainly in offering mentorship and coaching for BB as well as keeping the entire initiative on track

31 Beyond Belts Six Sigma Champions (SSC) are senior or middle level executives whose role is choosing and sponsoring specific projects. These people know both the business and the Six Sigma methodology.

32 Teamwork of LSS Organizing for Success and Working Relationships are essential for Six Sigma projects. Operating within small core teams is a core concept. Groups need to be small enough to accomplish goals and ensure scheduling of projects is a priority.

33 Teams are often created with like minded and experienced professionals as well as opposite departments to ensure inclusive decision making. Goal is to create aligned and cohesive group individuals while balancing operational efficiency and production of quality products.

34 Higher levels of teamwork create increased employee morale within the group and the entire company. People who are part of groups that are successful and more productive are generally happier. Groups that operate as a whole and are focused on the same goal are much more productive and operate more effectively.

35 Building Teams Building effective, functional teams is one of the most important pieces of LSS Things to keep in mind: Members must be personalized to the team s needs > not everyone needs to be on every team Members should represent as many of the stakeholders points of view as possible Members must be dedicated to making a positive impact on the project

36 The Sigma Levels Sigma is the geek symbol for summation. When used in relation to Six Sigma, it refers where a value falls in relation to how many standard deviations from the mean of a normal distribution it lies The higher the sigma level, the higher the precision and perceived quality

37 Normal Population Distribution 1 Sigma 1 Sigma = 68.2%

38 1 Sigma means that 31% of all products produced will be defective

39 Normal Population Distribution 2 Sigma 2 Sigma = 95.5%

40 Normal Population Distribution 3 Sigma 3 Sigma = 99.7%

41 Measurement Six Sigma is the measurement of defects (fall out results) per million opportunities 3 Sigma = 66,807 defects/million 4 Sigma = 6,210 defects/million 5 Sigma = 233 defects/million 6 Sigma = 3.4 defects/million Going up or down one sigma level can have a great impact on results

42 3 Sigma was the historical norm for quality systems 4 Sigma is the current technology standard in most industries 6 Sigma is the goal for quality in focused companies

43 But what does this REALLY mean? Why not 3 Sigma?

44 3 Sigma 3 Sigma Statistics = 99.7% 20,000 lost pieces of mail per hour 15 minutes of unsafe drinking water each day 5,000 incorrect surgical operations each week No electricity for 7 hours each month 40,500 newborn babies dropped each year 200,000 wrong drug prescriptions each year

45 But, if we move to 6 Sigma 200,000 incorrect drug prescriptions each year with 3 Sigma becomes 1 incorrect drug prescription every 25 years 40,500 newborns dropped every year with 3 Sigma becomes 3 newborns dropped every century (100 years)

46 CAP Example Each laboratory running full service testing (Chemistry, Coagulation, Urinalysis, Hematology, Transfusion Medicine, Point of Care and Microbiology without specialties like Histology, Cytology, Flow Cytometry, DNA, etc.) will be evaluated on approximately 3,000 standards/questions during each CAP inspection.

47 Number of Deficiencies to Expect Sigma Level # of Deficiencies Sigma Level # of Deficiencies 1 Sigma 954 every inspection cycle 2 Sigma 135 every inspection cycle 3 Sigma 9 every inspection cycle 4 Sigma 1 deficiency per 5.2 inspections (10 + years) 5 Sigma 1 deficiency per inspections (1,162 years) 6 Sigma 1 deficiency per 168,932 inspections (337,786 years)

48 The cost of defects and waste is usually higher that a company is aware. Not only are there financial consequences to defects, but there may be: Loss of reputation or worse, customers bad mouth the company Loss of morale among staff or worse, employees leave and no one wants to be hired by the company The WORST case, company goes out of business

49 For every $1 spent on Six Sigma activities by an organization, the return on investment (ROI) is $4

50 THE 99.9% PROBLEM HIGHER STANDARDS FOR HIGHER PERFORMANCE

51 Getting Started You can t fix a problem that you do not know about so the first goal of LSS is to discover all of the problems both apparent ones and those that are hidden KNOWLEDGE IS POWER

52 Discovery of problems is done through research and data collection After discovery, appropriate actions are taken to reduce the number of errors and amount of rework Actions must be measured to determine effectiveness All improvements are done with the ultimate goal of increasing the quality of output

53 Customers define the quality of a product or service. It doesn t matter if you think it s good, what does the customer think? If your service is not up to par, a customer will not buy it Patients won t visit your hospital they will choose other places for treatment New employees will not seek your job openings Administration will not fund your department

54 Customers demand and expect: Reliability Competitive Prices Top performance Efficient and timely delivery of goods or services

55 Know your customers If you do not know what your customer wants, ask! Ask physicians what they need for in house testing and turn around time Ask staff what they need for work conditions and supplies Ask administration what they want for productivity

56 DMAIC Systematic Six Sigma Process to perfect processes already in place D : DEFINE M : MEASURE A : ANALYZE I : IMPROVE C : CONTROL

57

58 For new processes For completely new processes for brand new products or services, the DMADV method is used D = DEFINE M = MEASURE A = ANALYZE D = DESIGN V = VERIFY

59 Each phase within the model has a significant purpose and different procedures/tools that are used to make sure results are correct. Teams are put together to make sure that each phase of the model in completed in the proper order.

60 DEFINE First phase of process In order to be successful and to be able to measure the degree or success or failure, a goal must be defined. While working in the define phase, team must discover requirements of all customers, both internal and external.

61 During the DEFINE phase, it is essential to answer several basic questions: What process needs to be improved? Who are the customers? What do the customers want?

62 Common Tools in DEFINE Interviews Surveys Brainstorming 7 Second Rule When asking questions, speaker must wait a full seven seconds after asking a question to allow individuals to comprehend and respond.

63 At the end of the DEFINE phase, the problem should be identified project goals should be established customers identified project boundaries (what will be addressed and what will not) customers expectations solidified

64 MEASURE The purpose of this step is to objectively establish current baselines as the basis for improvement. This is a data collection step, the purpose of which is to establish process performance baselines. We need to know where we started so we can measure against this to see if progress had been made.

65 Common Tools in MEASURE Data Collection including Check Sheets Gap analysis current state versus desired state Process Flow Charts/mapping Spaghetti diagrams Pareto Charts

66 At the end of the MEASURE phase, Enough data should be collected to understand the current sigma level or state of performance exactly as things are, not as we want them to be! Baseline performance should be firmly determined and solidified before proceeding to next step

67 ANALYZE The purpose of this step is to identify, validate and select root cause for elimination. In most cases there will be no more than three causes that must be controlled in order to achieve success if too many causes are identified, then the team has either not isolated the primary causes or the project goal is too ambitious to achieve success with a single project

68 Common Tools in ANALYZE 5 Whys and 1 How Root Cause Analysis Fishbone Diagrams Histograms Pareto charts Line Charts Detailed Process Maps Kaizen event Scatter Diagram Hypothesis Testing

69 Kaizen Event Japanese for "good change Kaizen refers to activities that continually improve all functions, and involves all employees a process that, when done correctly, humanizes the workplace, eliminates overly hard work and teaches people how to perform experiments on their work using the scientific method and how to learn to spot and eliminate waste in business processes.

70 The cycle of Kaizen activity can be defined as: Standardize an operation and activities, Measure the operation (find cycle time and amount of in process inventory). Gauge measurements against requirements. Innovate to meet requirements and increase productivity. Standardize the new, improved operations. Continue cycle ad infinitum.

71 At the end of the ANALYZE phase, List and prioritize potential causes of the problem Prioritize the root causes to pursue in the Improve step Identify how the process inputs affect the process outputs. Data is analyzed to understand the magnitude of contribution of each root cause. Detailed process maps are created to help pinpoint where in the process the root causes reside, and what might be contributing to the occurrence.

72 IMPROVE Focuses on fully understanding the top causes identified in the Analyze phase, with the intent of either controlling or eliminating those causes to achieve breakthrough performance by testing and implementing a solution to the problem. Identify creative solutions to eliminate the key root causes in order to fix and prevent process problems. Focus on the simplest and easiest solutions Test solutions using Plan Do Check Act (PDCA) cycle

73 Common Tools in IMPROVE Brainstorming Nominal Group Technique Most of the Analyze Tool Set Analysis of Variation (ANOVA) (Tool used at Black Belt Level) Simulation studies

74 At the end of the IMPROVE phase, the process must be run with its updated configuration and settings to check for improvement Potential solutions are developed and implemented for evaluation Contingency plans developed

75 CONTROL The purpose of this step is to sustain the gains. Monitor the improvements to ensure continued and sustainable success. Create a control plan. Update documents, business process and training records as required.

76 Attempt to CONTROL the future state process in order to: Ensure that any deviations from the target are corrected before they result in defects. Implement control systems such as statistical process control, production boards, visual workplaces, and continuously monitor the process.

77 Common Tools in CONTROL Control Chart Control Plans Cost savings calculations Standard Operating Procedures RAG Charts

78 At the end of the CONTROL phase, Standards and procedures are developed Process capability has been determined Benefits have been verified and cost savings/avoidance reviewed Project can be closed Celebrate successes! Learn from mistakes

79 Choosing Quality Tools

80

81 Introduction to LSS tools

82 BRAINSTORMING

83 When to use brainstorming: When a broad range of options is desired When creative, original ideas are desired When participation of the entire group is desired

84 Brainstorming Structured: Every person in the group must give an idea as their turn arises in the rotation or pass until the next round. It often forces shy people to participate but can also create a certain amount of pressure to contribute Unstructured: Group members give ideas as they come to mind. It tends to create a more relaxed atmosphere but also risks domination by the most vocal members

85 Brainstorming (continued) Write on a flip chart or board the issue being discussed and list EVERY idea. Having the words visible to everyone at the same time avoids misunderstandings and reminds others of new ideas. Record the words of the speaker without paraphrasing Never criticize ideas Finish quickly minutes works well

86 Brainstorming Considerations Judgment and creativity are two functions that cannot occur simultaneously. That s the reason for the rules about no criticism and no evaluation. Laughter and groans are criticism. When there is criticism, people begin to evaluate their ideas before stating them. Fewer ideas are generated and creative ideas are lost.

87 Evaluation includes positive comments such as great idea! That implies that another idea that did not receive praise was mediocre or worse. The more the better. Studies have shown that there is a direct relationship between the total number of ideas and the number of good, creative ideas. The crazier the better. Be unconventional in your thinking. Don t hold back any ideas. Crazy ideas are creative. They often come from a different perspective.

88 Crazy ideas often lead to wonderful, unique solutions, through modification or by sparking someone else s imagination. Hitchhike. Piggyback. Build on someone else s idea. When brainstorming with a large group, someone other that the facilitator needs to be the recorder. The facilitator acts as a buffer between the group and the recorder, keeping the flow of ideas going and ensuring that no ideas get lost before being recorded.

89 The recorder should try not to rephrase ideas. If an idea is not clear, ask for rephrasing from the idea generator, that everyone can understand. If the idea is too long to record, work with the person who suggested the idea to come up with a concise rephrasing. The person suggesting the ideas must always approve of what is recorded. Keep all ideas visible. When ideas overflow to addition flipchart pages, post previous pages around the room so all ideas are still visible to everyone.

90 Continue to generate and record ideas until several minutes silence produces no more ideas. Typical time frame to complete brainstorming ranges from 5 to 15 minutes. Timekeeper should limit time to 15 minutes unless ideas are still being generated at the end of that amount of time. After list is complete, ideas should be subjected to ranking of importance. Use of Nominal Group Technique works well for this.

91 NOMINAL GROUP TECHNIQUE

92 When to use Nominal Group Technique When some group members are much more vocal than others When some group members think better in silence When there is concern about some members not participating When the group does not easily generate quantities of ideas When all or some group members are new to the team When the issue is controversial or there is heated conflict After brainstorming or some other expansion tool has been used to generate a long list of possibilities When the list must be narrowed down When the decision must be made by group judgment

93 Nominal Group Technique Obtain list of problems or ideas using Brainstorming technique Discuss each idea in turn. Wording may be changed only when the idea s originator agrees. Ideas may be stricken from the list only by unanimous agreement. Discussion may clarify meaning, explain logic or analysis, raise and answer questions, or state agreement or disagreement.

94 Combine duplicate items to reduce list to useful and meaningful display of options. Number or letter all items on the final list so that voting can be easily done and final counts quickly tallied. Prioritize the ideas. Working individually, each team member chooses their top 5 items of importance from the list and ranks them using a scale of 1 to 5 with 5 being the most important or highest priority. This may be submitted in the form of a paper vote or verbally in turn.

95 Write the ranking number of each team member next to the questions they feel are important. Add all ranking numbers for each question and divide by the number of items ranked for an average or nominal rank. Write this number next to each item on the list and circle it. The item with the highest number is the most important to the team. Order the remaining items in a similar fashion plan team activities accordingly.

96 PROCESS MAPPING

97 Process mapping Process mapping refers to activities involved in defining what a business entity does, who is responsible, to what standard a business process should be completed, and how the success of a business process can be determined. What does your lab do? Who is responsible for which tasks? How are those tasks done? How do you know if you are successful?

98 The main purpose behind process mapping is to assist organizations in becoming more efficient. A clear and detailed process map or diagram allows LSS teams to come in and look at whether or not improvements can be made to the current processes.

99

100 Four Major Steps of Process Mapping 1. Process identification attaining a full understanding of all the steps of a process 2. Information gathering identifying objectives, risks, and key controls in a process.

101 3. Interviewing and mapping understanding the point of view of individuals in the process and designing actual maps 4. Analysis utilizing tools and approaches to make the process run more effectively and efficiently

102 How to Prepare a Process Map Assemble the Team. Agree on which process you wish to process map. Agree on beginning and ending points. Agree on level of detail to be displayed. Start by preparing a narrative outline of steps. Identify other people who should be involved in the process map creation, or asked for input, or to review drafts as they are prepared.

103 Important Rules of Process Mapping Process Map what is, not what you would like the process to be. Process Mapping is dynamic it is meant to CHANGE during development. Use Post it notes, dry erase markers, pencil, etc. All Process Maps must have start and stop points.

104 Example of How to for process mapping Specimen Processing: How are specimens processed in your laboratory? List each step from the arrival of the specimen up to the point where it is ready to be tested List the lab s SOPs along the process List the name of the person or the position responsible for each step Put the steps in order Determine what is missing

105 Sample Cardiac Cath Lab Process Map Source: GE Healthcare and New York Presbyterian Hospital

106

107

108 Value Added Flow Charts/ Stream Maps Value stream mapping is a lean manufacturing or lean enterprise technique used to document, analyze and improve the flow of information or materials required to produce a product or service for a customer. Value stream mapping is a paper and pencil tool that helps you to see and understand the flow of material and information as a product or service makes its way through the value stream.

109

110 Value Process map

111 SPAGHETTI DIAGRAMS

112 Spaghetti Diagrams The spaghetti diagram is a tool to help establish the optimum layout for a department based on observations of the distances travelled by patients, staff or products e.g. samples. Spaghetti diagrams expose inefficient layouts and identify large distances travelled between key steps. You Tube examples there are dozens to show you how to do this

113 Begin by drawing a diagram of the floor plan of the area you are evaluating. You then draw lines on it to map the flow of movement as it is now' e.g. plating a specimen in micro. Next, you assess this to help you redesign the process; this can act as a starting point for re drawing a new spaghetti diagram to reflect the to be' flow.

114 The tool helps you identify areas where time can be saved by visualizing unnecessary movement of products, staff or patients. The time saved can be used differently and therefore can help to reduce delays and be used to improve patient care.

115 Steps for drawing a spaghetti diagram Decide what you are going to observe (which process). You may decide to analyze a number of these simultaneously by using different colored lines to represent each flow. Draw the layout of the area and then draw lines on the diagram to represent the main flows of the staff member or patient. By analyzing the lines, you can identify any areas with unnecessary movement. This helps staff decide whether to bring two points closer together and optimizes the flow.

116 Spaghetti Diagram Guidelines Note the time, date and process being evaluated, but not the name of the individuals Explain to the team what's being done and ask for a volunteer Trace the actual steps taken Note any stops with sequential numbers and mark the time for each stop

117 Note any awkward elements in the line taken Mark any inherent interruptions in the path such as putting on PPE Note why certain trips are made (such as getting necessary supplies) Ask questions and seek suggestions from the team the best ideas often come from those who live the process

118

119 Plating a Specimen

120

121 5 S

122 The Five S s 5S is the name of a workplace organization method that uses a list of five Japanese words: seiri, seiton, seiso, seiketsu, and shitsuke The list describes how to organize a work space for efficiency and effectiveness by identifying and storing the items used, maintaining the area and items, and sustaining the new order

123 Seiri ( 整 理, SORT) Remove unnecessary items and dispose of them properly Make work easier by eliminating obstacles Reduce chance of being disturbed with unnecessary items Prevent accumulation of unnecessary items Evaluate necessary items with regard to cost or other factors.

124 Seiton ( 整, STRAIGHTEN or STREAMLINE) Arrange all necessary items in order so they can be easily picked for use Prevent loss and waste of time Make it easy to find and pick up necessary items Ensure first come first served basis Make workflow smooth and easy Can also be translated as "set in order"

125 Seiso ( 清 掃, SHINE) Clean your workplace completely Use cleaning as inspection Prevent machinery and equipment deterioration Keep workplace safe and easy to work Can also be translated as "sweep"

126 Seiketsu ( 清 潔, STANDARDIZE) Maintain high standards of housekeeping and workplace organization at all times Maintain cleanliness and orderliness Maintain everything in order and according to its standard.

127 Shitsuke ( 躾, SUSTAIN) To keep in working order Self discipline is necessary and depends on all individuals to maintain the component agreed upon Also translates as "do without being told"

128 Other phases are sometimes included e.g. safety, security, and satisfaction. These however do not form a traditional set of "phases" as the additions of these extra steps are simply to clarify the benefits of 5S and not a different or more inclusive methodology

129 A place for everything and everything in its place

130 Benefits of 5S according to a DSHS quality project in 2012 Reduced cycle times Increased floor space Improved working conditions Improved teamwork Established operations procedures Reduced lead times

131 Improved inventory management Improved safety Improved morale Enhanced communication Better adherence to Standard Operating Procedures (SOPs) Reduced search time Improved delivery times Enhanced levels of commitment Can be done on an individual level

132 DSHS 5S Project Results

133 5 WHYS (AND 1 HOW)

134 5 Whys and 1 How Technique to uncover and identify the root cause of problem as well as determine the relationship between the root cause (RC) and the problem. Very simple tool to use that requires NO statistical analysis Most useful when the problem involves human factors or interactions

135 Most RC can be found by asking WHY? five or fewer times If it takes more than 5 whys to get to a RC, the initial problem is too complex or complicated to effectively utilize this tool. Once the RC is found, the HOW part helps focus on resolving the issue for example, how can this be prevented for reoccurring?

136 Completing the 5 Whys Write down the problem this helps formalize the problem and describe it completely. It also helps the team focus on the same problem. Ask why? the problem happens and write the answer below the problem. If the answer does not identify the root cause, ask why? again continue until RC is found

137 FISHBONE DIAGRAMS

138 Fishbone Diagrams Also called Cause and Effect or Ishikawa diagrams visualization tool for categorizing the potential causes of a problem in order to identify its root causes Fishbone diagrams are typically worked right to left, with each large "bone" of the fish branching out to include smaller bones containing more detail.

139 How to create a fishbone diagram Create a head, which lists the problem or issue to be studied. Create a backbone for the fish (straight line which leads to the head). Identify at least four causes that contribute to the problem. Connect these four causes with arrows to the spine. These will create the first bones of the fish. Brainstorm around each cause to document those things that contributed to the cause. Use the 5 Whys or another questioning process to keep the conversation focused. Continue breaking down each cause until the root causes have been identified

140

141 6 M s 1.Man (personnel) 2.Machine 3.Methods 4.Materials 5.Measurements 6.Mother Nature (environment)

142 Mother Nature Man Method Cause Cause Cause Cause Cause Cause Cause Effect (Consequence) Cause Cause Cause Cause Measurement Machine Material

143 Mother Nature Man Method Only 1 tech on night shift Labor Intensive No slide warmer, must wait for slides to dry Generalists not trained Only one tech on 2 nd and 3 rd shift cleared to release GS results Multiple Steps Must centrifuge Body fluids/csf TAT on State Gram Stains is too long Results not entered in LIS immediately Manual GS method no instrument Back order on Stains Sample receipt time not documented Only one microscope in lab Problem with slides Measurement Machine Material

144 DATA STRATIFICATION

145 Stratification is a technique used in combination with other data analysis tools. When data from a variety of sources or categories have been lumped together, the meaning of the data can be impossible to see. This technique separates the data so that patterns can be seen.

146 When to use Data Stratification Before collecting data. When data come from several sources or conditions, such as shifts, days of the week, suppliers or population groups. When data analysis may require separating different sources or conditions

147 Stratification Procedure Before collecting data, consider which information about the sources of the data might have an effect on the results. Set up the data collection so that you collect that information as well. When plotting or graphing the collected data on a scatter diagram, control chart, histogram or other analysis tool, use different marks or colors to distinguish data from various sources. Data that are distinguished in this way are said to be stratified. Analyze the subsets of stratified data separately.

148 Here are examples of different sources that might require data to be stratified: Equipment Shifts Departments Materials Suppliers Day of the week Time of day Products

149 Stratification of Fishbone Diagram Data # of Tests Shift 1 Shift 2 Shift Monday Tuesday Wednesday Thursday Friday Saturday Sunday Day of Week

150 Data Breakdown Total Stat Tests Monday 40 Tuesday 45 for Analysis Wednesday 46 Thursday 50 Friday 53 Saturday 44 Sunday 47 Shift 1 Shift 2 Shift 3 Monday Tuesday Wednesday Thursday Friday Saturday Sunday

151 QUANTIFYING PROCESS VARIABILITY

152 Quantifying and Qualifying Process Variability Before making ANY changes to a process, it is essential to qualify the variability in a process (is there a little variation? A lot?) and to quantify it whenever possible TECH #1 reads and reports a routine gram stain in 5 minutes. TECH #2 does the same in 12 minutes Techs all use the same procedures and products for testing

153 Four Process States Ideal Threshold Brink of chaos State of chaos

154 Process States

155 Natural Process Degradation

156 CONTROL CHARTS AND PLANS

157 Control Charts/Plans Control Charts serve two purposes Primary = Tool to monitor process stability and control Secondary = Analysis Tool Remember that control does not necessarily mean the product of service will meet your needs. It only means that the process if consistent (may be consistently bad or good).

158 When to use Control Charts: When controlling ongoing processes by finding and correcting problems as they occur When predicting the expected range of outcomes from a process When determining whether a process if stable (in statistical control) When analyzing patterns of process variation from special causes (non routine events) or common causes (built into the process) When determining whether your quality improvement project should aim to prevent specific problems or to make fundamental changes to the process.

159 Sample Control Chart

160 Control charts have three main elements: Centerline the mathematical average of all of the samples plotted, Upper and Lower statistical control limits that define the constraints of common cause variations, Performance data plotted over time (UCL and LCL)

161 Generally, it is best to collect 20 to 25 groups of sample data before calculating the control limits. Upper and lower control limits MUST be statistically calculated. Don t confuse them with specification limits which are based of product requirements. Data must be kept in the exact sequence as it was gathered otherwise it is meaningless. Do not tweak the process beyond standard procedures while you are gathering the data. The data must reflect how it runs naturally.

162 Control Limits ensure that time is not wasted looking for unnecessary issues within a process. The help establish and quantify process variability If it s not broken, don t fix it

163 Calculating Control Limits Estimate the standard deviation of the sample data UCL is 3SD above the central mean line LCL is 3SD below the central mean line * 3 Sigma 99.73% of data will fall between the UCL and LCL *

164 Control Charts Other names for this type of chart include: Statistical Process Control chart, Stewhart Chart or Process Behavior Chart.

165 Out of Control Signs A single point outside of the control limits Two out of three successive points are on the same side of the centerline and farther than 2 σ (Sigma) from it Four out of five successive points are on the same side of the centerline and farther than 1 σ from it A run of eight in a row are on the same side of the centerline. This also applies if 10 of 11, 12 of 14 or 16 of 20 are on the same side of the centerline. Six or more points in a row steadily increasing or decreasing Fourteen or more points alternating up and down Obvious consistent or persistent patterns that suggest something unusual about your data and your process

166 Controlled Variation Controlled variation is characterized by a stable and consistent pattern of variation over time, and is associated with common causes. A process operating with controlled variation has an outcome that is predictable within the bounds of the control limits.

167

168 Uncontrolled Variation Uncontrolled variation is characterized by variation that changes over time and is associated with special causes. The outcomes of this process are unpredictable; a customer may be satisfied or unsatisfied given this unpredictability.

169

170

171 Rules of control limits You need to take action when a control chart shows: Any point outside of the control limits A Run of 7 Points all above or All below the central line Stop the production Perform a 100% check of samples Adjust the process Check five consecutive samples Continue the process

172 SWIM LANE/STREAMLINE DIAGRAMS

173 Processing Flow Charts and Swim Lanes A swim lane (or swimlane) is a visual element used in process flow diagrams, or flowcharts, that visually distinguishes responsibilities for sub processes of a process. Visual way to show everyone s responsibilities in the same chart

174

175

176 AFFINITY DIAGRAMS

177 Affinity Diagrams The affinity diagram is a tool used to organize ideas and data. People have been grouping data into groups based on natural relationships for thousands of years; however, the term affinity diagram was devised in the 1960s.

178 The tool is commonly used within project management and allows large numbers of ideas stemming from brainstorming to be sorted into groups, based on their natural relationships, for review and analysis. It is also frequently used in contextual inquiry as a way to organize notes and insights from field interviews. It can also be used for organizing other freeform comments, such as open ended survey responses, support call logs, or other qualitative data.

179 The affinity diagram organizes ideas with following steps: Record each idea on cards or notes. Look for ideas that seem to be related. Sort cards into groups until all cards have been used. Once the cards have been sorted into groups the team may sort large clusters into subgroups for easier management and analysis. Once completed, the affinity diagram may be used to create a cause and effect diagram

180

181 TREND CHARTS

182 Trend Charts Trend charts are also known as run charts, and are used to show trends in data over time. All processes vary, so single point measurements can be misleading. Displaying data over time increases understanding of the real performance of a process, particularly with regard to an established target or goal.

183 Characteristics of Trend Charts A clear Title to describe the subject of the chart. Labels on the vertical Y axis and horizontal X axis to describe the measurement and the time period. A Legend to differentiate the plotted lines Appropriate Scales that are narrow enough to show variation. Limited Characteristics on each chart to avoid confusion from too many lines. An appropriate Time Frame. Notations on any major spikes. Targets or Goals should be noted on the chart for reference. Note Who Prepared the chart in case there are questions about the chart or the data.

184 HISTOGRAMS

185 Histograms When to use a histogram: When the data are numerical When you want to see the shape of the data s distribution, especially when determining whether the output of a process is distributed approximately normally When analyzing whether a process can meet the customer s requirements When analyzing what the output from a supplier s process looks like When seeing whether a process change has occurred from one time period to another When determining whether the outputs of two or more processes are different When you wish to communicate the distribution of data quickly and easily to others

186 Histograms can be or have: Normal Distribution (Bell Curve) with Variability Skewed positive (right) or negative (left) Distribution Bi Modal (Double Peaked) Distribution Plateau Distribution Comb Distribution Truncated (Heart Cut) Distribution

187 Normal Distribution In a normal distribution, points are as likely to occur on one side of the average as on the other. Since other distributions may look similar to the normal distribution, statistical calculations must be used to prove a normal distribution. Skewed Distribution The skewed distribution is asymmetrical because of a natural limit that prevents outcomes on one side. The distribution s peak is off center toward the limit and a tail stretches away from it Bi-Modal Distribution The bi-modal (sometimes called double-peaked) distribution looks like the back of a two-humped camel. The outcomes of two processes with different distributions are combined in one set of data.

188 Plateau Distribution The plateau distribution (sometimes called Multimodal) occurs when several processes with normal distributions are combined. Because there are many peaks close together, the top of the distribution resembles a plateau. Comb Distribution The comb distribution (sometimes called Saw Toothed) appears as an alternating jagged pattern and often indicates a measuring problem with improper gage readings or use of a gage that is not sensitive enough for readings Truncated Distribution The truncated distribution (sometimes called Heart-cut or short tailed) looks like a normal distribution with the tails cut off since the tails approach zero very fast. This may also indicate that the outlying portion of the process has not been including in the data collection.

189 Normal to Skewed Distribution

190 Bi Modal Distribution

191 PARETO CHARTS

192 Pareto Charts A Pareto Chart is a specialized type of bar chart where the values being plotted are arranged in descending order with the longest bars on the left. The lengths represent the frequency. Utilizes the 80/20 Rule 80% of the problems stem from 20% of the causes

193 When to use a Pareto Chart When analyzing data about the frequency of problems or causes in a process When there are many problems or causes and you want to focus on the most significant When analyzing broad causes by looking at their specific components When communicating with others about your data

194 Creating Pareto Charts Decide on what categories you will use to group items. Decide what measurement is appropriate, Common measurements are frequency, quantity, cost and time. Decide what period of time the Pareto chart will cover i.e., one full day? One week? One month? Etc.

195 Collect the data, recording the category each time. If data already exists, assemble it. Subtotal the measurements for each category Determine the appropriate scale for the measurements collected. The maximum value will be the largest value from the sum of subtotals. Mark the scale on the left side of the chart. Construct and label bars for each category. Place the tallest bar on the far left, then the next tallest to its right and so on. If there are any categories with small measurements, they can be grouped as other.

196 Calculate the percentage for each category: the subtotal for that category divided by the total for all categories. Draw a vertical axis and label it with the percentages. Be sure that the two scales match. For example, the left measurement that corresponds to one half should be exactly opposite 50% on the right scale. Calculate and draw cumulative sums. Add the subtotals for the first and second categories and place a dot above the second bar indicating the sum. To that sum, add the subtotal for the third category and place a dot above the third bar for that new sum. Continue the process with all of the bars. Connect the dots, starting at the top of the first bar. The last dot should reach 100percent on the right scale.

197 Specimen Rejection Reasons

198 40 Specimen Rejection Reasons 100% 35 90% 30 80% 70% Frequency % 50% 40% 10 30% 20% 5 10% 0 Hemolyzed Clotted QNS Wrong Tube Mislabeled Too Old Improper Temp Wrong Patient Reason 0%

199 SCATTER DIAGRAMS

200 Scatter Diagrams Scatter diagrams are used to study the possible relationship between one variable and another. These diagrams are used to test for possible Cause and Effect relationships.

201 When to use a Scatter Diagram When you have paired numerical data When your dependent variable may have multiple values for each value of your independent variable When trying to determine whether the two variables are related such as: When trying to identify potential root causes of problems After brainstorming causes and effects using a fishbone diagram, to determine objectively whether a particular cause and effect are related When determining whether two effects that appear to be related both occur with the same cause When testing for autocorrelation before constructing a control chart

202 If the variables are correlated, the points will fall along a line or curve. The better the correlation, the tighter the points will hug the line. The more the diagram resembles a straight line, the stronger the relationship. Even if a scatter diagram shows a relationship, do not assume that one variable caused the other. They both may be influenced by a third variable. If the scatter diagram shows no relationship between the two variables, consider whether the data might be stratified.

203 If the diagram shows no relationship, consider whether the independent (x axis) variable has been varied widely. Sometimes a relationship is not apparent because the data don t cover a wide enough range. Think creatively about how to use scatter diagrams to discover a root cause. Drawing a scatter diagram is the first step in looking for a relationship between variables.

204 Preparing a Scatter Diagram 1. Collect pairs of data where a relationship is suspected. 2. Draw a graph with the independent variable on the horizontal axis and the dependent variable on the vertical axis. For each pair of data, put a dot where the x axis value intersects the y axis value. If two dots fall together, put them side by side, touching, so that you can see both.

205 3. Look at the pattern of points to see if a relationship is obvious. If the data clearly form a line or curve, you may stop as the variables are correlated. For correlated data, regression or correlation analysis can now be performed. If no relationship can be seen, progress with steps 4 through Divide points on the graph into four quadrants. Draw the horizontal line half way between the number of points from top to bottom. Draw the vertical line half way between the number of points from left to right.

206 5. Count the points in each quadrant. Do not count the points on a line. 6. Add the diagonally opposite quadrants. Find the smaller sum and total of points in all quadrants. A = points in the upper left plus points in the lower right B = points in the upper right plus points in the lower left Q = the smaller of A and B N = A plus B

207 7. Look up the limit for N on the trend test table. If a line is not clear, statistics (N and Q) determine whether there is reasonable certainty that a relationship exists. If Q is less than the limit, the two variables are related If Q is greater than or equal to the limit, the pattern could have occurred from random chance

208 Trend Test Table

209 Positive Correlation Scatter Diagram

210 Negative Correlation Scatter Diagram

211 No Correlation Scatter Diagram

212 FOCUS P D C A

213 FOCUS P D C A One of the most common models used from process evaluation and improvement

214 FOCUS Phase Narrow attention to a discrete opportunity for improvement

215 PDCA Cycle

216 Allows the team to pursue the selected opportunity and to review its outcome.

217

218

219 Many people think that Lean is about cutting heads, reducing the work force or cutting inventory. Lean is really a growth strategy. It is about gaining market share and being prepared to enter in or create new markets. Ernie Smith, Lean Event Facilitator in the Lean Enterprise Forum at the University of Tennessee

220 Putting it all together Initiate a project Get team together Determine current state of affairs Decide what team wants to accomplish Do the hard part the work of the project to make the change Once project is well underway, pause to measure effectiveness

221 If things are going well and goals are being achieved, continue with project. If not, regroup and revise the project plan. Measure progress again and again Once steady state is achieved, it s time to ensure process is prepared for future control Before wrapping project up, document successes and opportunities