1. March 16, 2016 CanadianClinicalDiagnostics.com ©Canadian Clinical Diagnostics

2. DEFINE MEASURE ANALYZE  FMEA fits best in Analyze IMPROVE CONTROL LEAN SIX SIGMA PROJECT PLAN – GANTT CHART

3. The 2 Most Powerful Components of any Risk Management program in Healthcare: FMEA VS. FRACAS FMEA = PREVENTION The failure rate is Zero; Successful FMEA Eliminates Risk through Detection and Prevention Controls. Ie. The error event has NOT happened. FRACAS = CORRECTION Reduction of a Too-High Failure rate to a Lower rate; Successful FRACAS Reduces Frequency or Opportunity to re- occur.

4. JCAHO Standard Req. L.D. 5.2 ISO 15189:2012 Supportive Reference FMEA = PREVENTION: ISO15189:2012 4.11 4.11 Preventive action The laboratory shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. The laboratory shall have a documented procedure for: a) reviewing laboratory data and information to determine where potential nonconformities exist; b) determining the root cause(s) of potential nonconformities;

5. ISO 15189:2012 Supportive Reference FMEA = PREVENTION: ISO15189:2012 4.11 4.11 Preventive action (Cont) c) evaluating the need for preventive action to prevent the occurrence of nonconformities; d) determining and implementing preventive action needed; e) recording the results of preventive action taken (see 4.13);

6. ISO 15189:2012 Supportive Reference FRACAS = CORRECTION: ISO15189:2012 4.10 4.10 Corrective action The laboratory shall take corrective action to eliminate the cause(s) of nonconformities. Corrective actions shall be appropriate to the effects of the nonconformities encountered. The laboratory shall have a documented procedure for: a) reviewing nonconformities; b) determining the root causes of nonconformities; c) evaluating the need for corrective action to ensure that nonconformities do not recur;

7. ISO 15189:2012 Supportive Reference FRACAS = CORRECTION: ISO15189:2012 4.10 4.10 Corrective action (Cont.) d) determining and implementing corrective action needed; e) recording the results of corrective action taken (see 4.13); f) reviewing the effectiveness of the corrective action taken (see 4.14.5). NOTE: Action taken at the time of the nonconformity to mitigate its immediate effects is considered “immediate” action. Only action taken to remove the root cause of the problem that is causing the nonconformities is considered “corrective” action.

8. 1. Select a process or interrelated processes to analyze; one error can be not identifying the linkages of failure modes between processes 2. Define the scope: What is the Critical to Quality (CTQ)metric (VOC or KPOV)? What do you want to accomplish and Why? Who is on the team? What data to we need? Do we have the right collection of people? 3. Establish the team – parts of scope can be determined after the team has met.

9. 4. Map the process – completely; Each path in the process is identified with a number Each discrete process step description is given a decimal ie..01,.02 for each Failure mode Therefore, the first thing that could go wrong in the process is identified as Failure Mode 1.01;

10. 5. Brainstorm potential Failure Modes (what could go wrong for each step) Process Description: Identify/Describe the Process step where the Failure Mode occurs; Failure Mode Description: Identify specifically what could go wrong at this step in the process; Potential Failure Causes: Identify specifically why the Failure Mode would happen; Potential Failure Effects: Identify specifically what effect the Failure Mode would have on the process. What would be the consequences of each Failure?

11. 5. Attribute SI, DI, FI scores to each Failure Mode Discuss amongst the team to determine the reasonable worst case scenario for each Failure. If a consensus cannot be reached, it is better not to under-estimate a severe failure mode. Severity Index (SI) How Severe is the Failure to the Process? Severity DescriptionScore NO Effect1 Slight2 Moderate3 Major4 Severe/Catastrophic5

12. 5. Attribute SI, DI, FI scores to each Failure Mode Detectability Index (DI) How Easy is it to see it in time to prevent it (Before it occurs/Prior to impact)? Detectability DescriptionScore Always1 Likely2 Sometimes3 Unlikely4 Never5

13. 5. Attribute SI, DI, FI scores to each Failure Mode Frequency (or Probability) Index (FI) How often (likelihood) would this failure occur? How often is this task performed? Frequency DescriptionScore Yearly1 Monthly2 Weekly3 Daily4 Hourly5

14. 6. Calculate Risk Priority Number (RPN) Product of the SI x DI x FI = RPN (Pre-FMEA); The higher the score, the more critical the Failure Mode; Prioritize the Failure Modes using the Pareto Principle (highest 20% RPN Scores). 7. Brainstorm Control Measures Identify examples of Detection and/or Prevention control measures or methods/actions that can be put into place in order to decrease the DI or FI scores; Provide proposed actions; Who is Responsible and what is the target date of completion? Use a Gantt chart.

15. 7. Brainstorm Control Measure Examples (Poka- Yoke) Forcing Functions Automation/Computerization Simplification/Standardization eg. 5S Training/Education/Orientation Checklists Direct Observation (or other) Audits Reminders/Checklists/Double Checks Rules/ROPs/SOPs/Standard Work or Job Aids Information/Communication – (1-time and Serial)

16. 8. Determine the Level of Effective and Efficiency of the Prevention Controls and Detection Controls If the process needs to be re-designed – go back and re- examine to increase detection and prevention of risk and to decrease RPN scores. 9. Calculate Risk Priority Number (RPN) Product of the SI x DI x FI = RPN (Post-FMEA);

17. 10. Calculate Risk Priority Index (RPI) to Quantitate Risk Mitigation through FMEA Add all Failure Mode RPN scores (Pre-FMEA) and all Failure Mode RPN scores (Post-Controls) The ∆ of the Pre-FMEA RPN – Post FMEA RPN x 100% Report the quantification of Risk Mitigation to Senior Team 11. New/Large Processes need to be re-examined in the Plan-Do-Check-Act model Implement pilot and monitor the new process; Re-examine process in 3-6 months, or as FRACAS dictates