CE Disclosure. Potential Failure and RCA 7/2/2014

Transcription

1 Potential Failure and RCA Helene Eckrich & Leon Spackman Potential Failure and Root Cause Analysis: Key Tools to Identify Potential Failures and Solve Problems to Attain High Reliability Workshop B // March 6, 2014 // 8:15am-noon Attaining High Reliability and Safety for Patients Collaborating for Change. Patient Safety Collective of the Southwest (PSCS). March 6-7, 2014; Albuquerque, NM CE Disclosure In compliance with the ACCME/NMMS Standards for Commercial Support of CME: Helene Eckrich, RN, MSN Leon Spackman, MS have been asked to advise the audience that each has no relevant financial relationships to disclose or does have relevant financial relationships to disclose which they will disclose here. Attaining High Reliability and Safety for Patients Collaborating for Change. Patient Safety Collective of the Southwest (PSCS). March 6-7, 2014; Albuquerque, NM 1

2 Potential Failure and Root Cause Analysis Key Tools to Identify Potential Failures and Solve Problems to Attain High Reliability Helene Eckrich RN, MSN Leon Spackman PMP, LSS Master Black Belt Manager, PMO TriCore Reference Laboratories Agenda Introductions What is FMEA? When do you use it? How to use a FMEA worksheet? How do you interpret a FMEA? Pareto Charts--show results Root Cause Analysis Develop a Fishbone Diagram Summary 2 2

3 FMEA vs Root Cause Analysis FMEA will address risks that have not yet happened Identify potential events that may happen in the future Identify the effect Prioritize Root Cause Analysis will identify the Root Cause of an event that has already occurred Focus on prevention so it doesn t happen again Find Root Cause(s) not symptoms 3 Risks in Healthcare Medication Errors Hospital Infections Surgical Errors Wrong patient, wrong site, wrong procedure Retention of foreign bodies Delay in Treatment Safety Issues (slips, trips, falls) Costs: $20 Billion - $1 Trillion Source: The Joint Commission 4 3

4 What is FMEA? FMEA--a tool to identify risks in your process Can be used in multiple places in process improvement Determine where problems are Help identify cause/effect relationships Highlight risks in solutions and actions to take Starts with input from processes Identifies three risk categories Severity of impact Probability of occurrence Ability to detect the occurrence 5 When to Use Early stages (Define) to understand process and identify problem areas Analyze data (Analyze) to help identify root causes Determine best solutions (Improve) with lowest risk Close out stage (Control) to document improvement and identify actions needed to continue to reduce risk 6 4

5 FMEA Worksheet or Product Name Person Responsible Prepared by: Page of Date (Orig) Revised Step Key Input Potential Failure Mode Potential Failure Effect Sev Potential Causes Oc c Current Controls Det RP Actions N Recommended Sev Oc Det RP c N Sev - Severity of the failure (what impact will it have on our process?) Occ How likely is the event to occur (probability of occurrence) Det How likely can the event be detected in time to do something about it RPN Risk Priority Number (multiply Sev, Occ, and Det) 7 How To Complete the FMEA General Suggestions Use large white board or flip chart with a FMEA form drawn on it during the generation phase Focus the team on the specific area of study (product or process) Have process map available Have all subassemblies and component part of a product 8 5

6 Mapping Before we can identify risk (FMEA) or Root Causes, we must understand and define our process Mapping provides a clear, visual way to examine processes Helps identify redundancies, waste, and weaknesses 9 Why Map es? The way you think it is. What the customer expects, and is willing to pay for. The way it really functions. 10 6

7 No 7/2/2014 Symbols Boundary Reference Document Task Multiple Documents Decision Data Base Embedded Connector 1 1 Putting It All Together Data Base Yes 12 7

8 to Change Oil in a Car 5000 miles driven Drive car on lift Drain Oil Replace Filter Sele ct Oil Fill with new oil Take Car off lift Complete Wrong Get Correct Oil 13 How to Complete the FMEA Step 1. Complete header information Step 2. Identify steps in the process Step 3. Brainstorm potential ways the area of study could theoretically fail (failure modes) 14 8

9 FMEA Worksheet or Product Name Person Responsible Leon Mechanic Change Oil in Car Prepared by: Leon Page _1 of 1 Date (Orig) 6 March 2014 Step Key Input Fill with New new oil Oil Mecha nic Potential Failure Mode Wrong type of oil No oil added Potential Sev Potential Failure Effect Causes Engine wear Engine Failure Oc c Current Controls Det RP Actions N Recommended Sev Oc Det RP c N Sev - Severity of the failure (what impact will it have on our process?) Occ How likely is the event to occur (probability of occurrence) Det How likely can the event be detected in time to do something about it RPN Risk Priority Number (multiply Sev, Occ, and Det) 15 How to Complete the FMEA Step 4 For each failure mode, determine impact or effect on the product or operation using criteria table (next slide) Rate this impact in the column labeled SEV (severity) 16 9

10 Severity (SEV) Rating SEV Severity Product/ Criteria 1 None No effect 2 Very Minor Defect would be noticed by most discriminating customers. A portion of the product may have to be reworked on line but out of station 3 Minor Defect would be noticed by average customers. A portion of the product (<100%) may have to be reworked on line but out of station 4 Very Low Defect would be noticed by most customers. 100% of the product may have to be sorted and a portion (<100%) reworked 5 Low Comfort/convenience item(s) would be operable at a reduced level of performance. 100% of the product may have to be reworked 6 Moderate Comfort/convenience item(s) would be inoperable. A portion (<100%) of the product may have to be scrapped 7 High Product would be operable with reduced primary function. Product may have to be sorted and a portion (<100%) scrapped. 8 Very High Product would experience complete loss of primary function. 100% of the product may have to be scrapped 9 Hazardous Warning Failure would endanger machine or operator with a warning 10 Hazardous w/out Warning Failure would endanger machine or operator without a warning 17 FMEA Worksheet or Product Name Person Responsible Leon Mechanic Change Oil in Car Prepared by: Leon Page of Date (Orig) 6 March 2014 Revised Step Key Input Fill with New new oil Oil Mecha nic Potential Failure Mode Wrong type of oil No oil added Potential Sev Potential Failure Effect Causes Engine wear Engine Failure 2 10 Oc c Current Controls Det RP Actions N Recommended Sev Oc Det RP c N Sev - Severity of the failure (what impact will it have on our process?) Occ How likely is the event to occur (probability of occurrence) Det How likely can the event be detected in time to do something about it RPN Risk Priority Number (multiply Sev, Occ, and Det) 18 10

11 How to Complete the FMEA Step 5 For each potential failure mode identify one or more potential causes Rate the probability of each potential cause occurring based on criteria table (next slide) Place the rating in the column labeled OCC (occurrence). 19 FMEA Occurrence (OCC Rating) OCC Occurrence Criteria 1 Remote 1 in 1,500,000 Very unlikely to occur 2 Low 1 in 150,000 3 Low 1 in 15,000 Unlikely to occur 4 Moderate 1 in 2,000 5 Moderate 1 in 400 Moderate chance to occur 6 Moderate 1 in 80 7 High 1 in 20 High probability that the event will occur 8 High 1 in 8 9 Very High 1 in 3 Almost certain to occur 10 Very High > 1 in

12 FMEA Worksheet or Product Name Person Responsible Leon Mechanic Change Oil in Car Prepared by: Leon Page of Date (Orig) 6 March 2014 Revised Step Key Input Fill with New new oil Oil Mecha nic Potential Failure Mode Wrong type of oil No oil added Potential Sev Potential Failure Effect Causes Engine wear Engine Failure Oc c 2 Mis-labeled 3 10 Hurrying 3 Current Controls Det RP Actions N Recommended Sev Oc Det RP c N Sev - Severity of the failure (what impact will it have on our process?) Occ How likely is the event to occur (probability of occurrence) Det How likely can the event be detected in time to do something about it RPN Risk Priority Number (multiply Sev, Occ, and Det) 21 How to Complete the FMEA Step 6 Identify current controls or detection Rate ability of each current control to prevent or detect the failure mode once it occurs using criteria table (next slide) Place rating in DET column 22 12

13 FMEA Detection (DET) Rating DET Detection Criteria 1 Almost Certain Current Controls are almost certain to detect/prevent the failure mode 2 Very High Very high likelihood that current controls will detect/prevent the failure mode 3 High High Likelihood that current controls will detect/prevent the failure mode 4 Mod. High Moderately High likelihood that current controls will detect/prevent the failure mode 5 Moderate High Likelihood that current controls will detect/prevent the failure mode 6 Low Low likelihood that current controls will detect/prevent failure mode 7 Very Low Very Low likelihood that current controls will detect /prevent the failure mode 8 Remote Remote likelihood that current controls will detect/prevent the failure mode 9 Very Remote Very remote likelihood that current controls will detect/prevent the failure mode 23 FMEA Worksheet or Product Name Person Responsible Leon Mechanic Change Oil in Car Prepared by: Leon Page of Date (Orig) 6 March 2014 Revised Step Fill with new oil Key Input New Oil from supplier Potential Failure Mode Potential Failure Effect S e v Wrong type Engine wear 2 of oil Potential Causes Oc Current Controls Det RPN c Misread oil chart 3 None 9 for vehicle Actions Recommended Sev Oc Det RP c N No oil added Engine Failure 10 Hurrying 3 Engine light 3 Sev - Severity of the failure (what impact will it have on our process?) Occ How likely is the event to occur (probability of occurrence) Det How likely can the event be detected in time to do something about it RPN Risk Priority Number (multiply Sev, Occ, and Det) 24 13

14 How to Complete the FMEA Step 7 Multiply SEV, OCC and DET ratings and place the value in the RPN (risk priority number) column. The largest RPN numbers should get the greatest focus. For those RPN numbers which warrant corrective action, recommended actions and the person responsible for implementation should be listed. SEV OCC DET = RPN ( = 54 ) Step Fill with new oil Key Input New Oil from supplier Potential Failure Mode Potential Failure Effect Wrong type Engine of oil wear Sev Potential Causes 2 Misread oil chart for vehicle Occ Current Controls Det RPN 3 None 9 54 Actions Recommended Sev Occ Det RPN No oil added Engine Failure 10 Hurrying 3 Engine light FMEA Rankings Rating Hazardous without warning High 10 Low 1 Severity Occurrence Detection Loss of primary function Loss of secondary function Very high and almost inevitable Cannot detect or detection with very low probability High repeated failures Remote or low chance of detection Moderate failures Low detection probability Minor defect Occasional failures Moderate detection probability No effect Failure Unlikely Almost certain detection Source: The Black Belt Memory Jogger, Six Sigma Academy 26 14

15 Action Results Step 8 After corrective action has been taken, place summary of the results in the Actions Recommended block Assign new value for: Severity Occurrence Detection Calculate new RPN number 27 FMEA Worksheet or Product Name Person Responsible Leon Mechanic Change Oil in Car Prepared by: Leon Page of Date (Orig) 6 March 2014 Revised Step Fill with new oil Key Input New Oil from supplier Potential Failure Mode Potential Sev Potential Failure Effect Causes Wrong type Engine wear 2 of oil Oc Current Controls Det RPN c Misread oil 3 None 9 54 chart for vehicle Actions Recommended Sev Occ Det RP N No oil added Engine Failure 10 Hurrying 3 Engine light 3 90 Oil level checked by partner Sev - Severity of the failure (what impact will it have on our process?) Occ How likely is the event to occur (probability of occurrence) Det How likely can the event be detected in time to do something about it RPN Risk Priority Number (multiply Sev, Occ, and Det) 28 15

16 FMEA Example or Product Name: Emergency Room Visit (Heart) Prepared by: Page of Person Responsible: Helene Quality Date (Orig) Revised Step Key Input Potential Failure Potential S Mode Failure Effect e v Potential Causes Occ Current Controls D e t R P N Actions Recommended S e v O c c D et RPN Intake Desk Triage Wrong Assessment Wait too long 10 Did not recognize 2 None and have cardiac arrest heart attack symptoms unusual symptoms Diagnosis Triage nurse report Waiting for tests Cardiac (Labor EKG) Arrest 10 Understaffed 4 Staffing patterns 2 80 Treat-ment Testing Inconclusive Test Results Send home instead of admit Cardiac Arrest 10 Read wrong patient test results 2 When medical staff saw correct patient name and ID Pareto Chart Sorted Bar Chart with the bars arranged in descending order from left to right Useful in taking a spreadsheet of data and showing which category stands out from the rest. Identify where the biggest pain occurs in process Help determine where to focus our efforts Based on 80/20 rule 30 16

17 Pareto Chart Example R P N Nu m be r 31 Pareto Chart Hints List categories in descending order on horizontal line & frequencies on vertical line Look for the 80/20 breakpoint Break down tall pole into another Pareto Chart for further analysis Involve customer/sponsor in selecting area to focus on 32 17

18 Group Exercise #1 Build a FMEA to identify problem areas to be addressed in your process (Breast Surgery) Identify process step(s) to analyze Brainstorm for possible failure modes, effects, causes and detection controls Rate severity, occurrence, and detection Analyze results with a Pareto Chart Report to the group 33 Out Patient Breast Surgery Patien t Arrive s Holding Area (Prep Patient) Anesthesia Operating Room PAC U Out Patient Surgery Unit and Discharge Go Home 34 18

19 Summary FMEA identifies risk in our processes Impact/Severity Probability of Occurrence Detection Helps identify what can go wrong and what we should fix Can be used in multiple stages of process improvement Pareto Chart Measures pain in the process 35 Root Cause Analysis 19

20 Overview What is a root cause analysis? Why is it important? How do you do it? Summary 37 What is Root Cause Analysis Event has occurred and we don t want it to happen again. Practice to solve problems by attempting to identify and correct the root causes of events, as opposed to simply addressing their symptoms. Studying the process, analyzing all data, and finding the real reason for the failure/event Source: Wikipedia 38 20

21 What is Root Cause Analysis Aiming corrective measures at root cause is more effective than merely treating the symptoms of a problem Must be performed systematically, and conclusions must be backed up by evidence There is usually more than one root cause for any given problem 39 Why Root Cause Analysis Solves the problem once and for all at the place that it occurs Focuses on prevention, not detection Reduces waste Frees personnel to do their jobs--not chase symptoms 40 21

22 Band-Aid Fixes Solving symptoms not root cause Emphasis on action vs. solving problems Temporary solutions or symptoms can cause many more problems & create waste if they become the preferred solution 41 Band Aid Fixes Temporary solutions are OK But you must document them to ensure they are replaced with lasting preventative solutions If you continue using band aid fixes, you could have a process like this 42 22

23 Root Cause Analysis Understand the process map it Gather data Identify possible root causes (the vital few) Tool Fishbone Diagram Validate Fishbone Diagram with data/knowledge Identify solutions based on root causes 44 23

24 Gather Data Collect data about the event that has occurred Analyze the data Identify key measures in process How often has event occurred? What is effect of problem? 45 Brainstorming Definition Brainstorming is a group technique for generating a large quantity of ideas about a specific topic in a relatively short period of time

25 Brainstorming Get as many ideas as you can Organize using tools (Pareto Chart) Don t jump to problem solving until you have identified the root cause 47 Brainstorming Call out ideas and collect on flip charts Round robin, pass if no idea Anonymously writes on stickies Record every idea in the speaker s words Don t criticize until after ideas are generated Fast pace--fosters high energy and anything goes atmosphere Go for Quantity Don t quit at the first pass; pause; and press on 48 25

26 Brainstorming The best way to get a good idea is to get a lot of ideas. -- Linus Pauling 49 Fishbone Diagram MEASUREMENTS METHODS PEOPLE Ask why each of these categories affects the problem (problem to be analyzed goes here) When you record a cause, ask why again to identify any sub causes ENVIRONMENT TOOLS MATERIALS 50 26

27 Fishbone Diagram MEASUREMENTS METHODS PEOPLE Causes here Sub causes here (problem to be analyzed goes here) Causes here ENVIRONMENT TOOLS MATERIALS 51 Group Activity #2 Build a Fishbone Diagram based on patient scenario Use markers and paper on table Determine the root causes for Heparin Overdose Report Out from each group 52 27

28 Report Out Each group reports outs Please be courteous while others reporting out 53 Solve the Root Cause Verify the root cause Brainstorm for solutions to problem Select best solution(s) Implement and measure to ensure improvement Monitor and control Policies and Procedures Audits Scorecards 54 28

29 Summary: Root Cause Analysis What: Studying the process, analyzing all data, and identify the real reason for the failure/event Why do RCA: We often focus on symptoms Need to solve the problem once and for all Gets rid of waste Focuses on prevention not detection Frees up personnel to focus on important tasks 56 29

30 Summary FMEA Identify Risk Prioritize what has the most effect Root Cause Prevent an event from happening again Find the Root Cause not a symptom Continuous Improvement 57 Continuous Improvement improvement not a linear process Never really ends Journey not a destination Define Control Measure Improve Analyze 58 30

31 Challenge We are what we repeatedly do. Excellence, therefore, is not an act but a habit. -- Aristotle 59 Sdkljfgaskjfha;hfas; dhfas;dflknasd;lfks dfl kasdf lasdkjfas; djfasd l;fksld/kfj as djasd jasd Questions? Helene Eckrich RN, MSN Leon Spackman Manager, PMO TriCore Reference Laboratories leon.spackman@tricore.org (505) (Work) (505) (Cell) Attaining High Reliability and Safety for Patients Collaborating for Change. Patient Safety Collective of the Southwest (PSCS). March 6-7, 2014; Albuquerque, NM 31