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 Description Score
NO Effect 1
Slight 2
Moderate 3
Major 4
Severe/Catastrophic 5
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 Description Score
Always 1
Likely 2
Sometimes 3
Unlikely 4
Never 5
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 Description Score
Yearly 1
Monthly 2
Weekly 3
Daily 4
Hourly 5
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
