3. Risk Identification
• Risk identification is the process through which
we become aware of risks in the health care
environment that constitute potential loss
exposures for the institution.
4. Systems for Risk Identification
Informal Risk Identification Systems
– Claims data
– Medical record reviews
– Patient complaints
– Standardized surveys and questionnaires
– Personal inspections
– Committee minutes
– Survey or regulatory reports
– Recall notices
– Experts
5. Systems for Risk Identification
Formal Risk Identification Systems
– Incident reporting
– Occurrence reporting and screening
– Sentinel event tracking
– Failure mode and effect analysis
– Device reporting and tracking logs
– Security reports
6. Risk Identification
• Identification of risks is important but early
identification is our goal
• Early identification is important because :
1- A prompt investigation can be initiated while
information is still fresh and available.
2- An early intervention can be considered.
3- A high potentiality of eliminating or reducing the
cost of the claim.
7. Risk Identification
2 main methods to identify risks :
1- Incident reporting
2- Generic / Occurrence screening
Both aim at early identification of risks and
take appropriate measures to eliminate or
limit liability exposures.
8. Incident / occurrence Reporting
• Definition of incident: any happening that is
not consistent with the routine care of a
particular patient or an event that is not
consistent with the normal operations of a
particular organization.
• Considered as early warning system.
• The analysis result should be revised by
process owners and who have the authority
to make changes in protocols ,policies and
procedures
9. Content of the Incident Report
• vary in content and structure and vary
from organization to organization
• emphasis has been placed on making
forms “user friendly,”
10. Content of the Incident Report
Demographic information :
• including name, home address, and telephone number of the
patient, visitor, or employee involved in the incident. (For patients,
medical record numbers also may be recorded as part of the
identifying information.)
• This information is used to identify the potential claimant and
witnesses in case of litigation.
Facility-related information : such as admission or visit date, patient
identification number, patient room number, and admitting diagnosis
or presenting complaint.
This is used as aggregate data to determine whether certain units of
the system are more incident prone.
Trending this information promotes risk management intervention and
actions plan to react to frequency or severity in incidents reported.
11. Content of the Incident Report
Socioeconomic data : on the individual
involved in the occurrence, such as age,
gender, marital status, employment, and
insurance status.
This information aids in assessing potential
loss. For example, collecting employment
status assists the risk manager and counsel
in determining the potential for wage loss or
economic (loss of salary) damage.
12. Categories according to type of
event
• Medication error
• Adverse drug reaction
• Fall
• Equipment problem
• Complication related to procedure , treatment , or
test
• Transfusion event
• Behavioral problem( e.g. , assault , elopement
,etc.)
• Visitors events
• Unsafe conditions with potential for harm
13. Categories according to harm to
patient
• Category A: circumstances or events that have the
capacity to cause error but no error occurred.
• Category B: An error occurred but the error did not
reach the patient i.e. no harm occurred ( near
miss )
• Category C: an error occurred that reached the
patient, but did not cause patient harm.
• Category D: An error occurred that may have to or
resulted in harm to the patient and required
intervention
• Category E: an error occurred that may have to or
resulted in the patient’s death ( sentinel event )
14. Staff Participation in Incident
Reporting
• Incident reporting should be the responsibility of
all staff , responsibility for completing an incident
report rests with any facility staff members who
witnesses, discovers, or has direct knowledge
with the incident.
15. Staff Participation in Incident Reporting
Barriers How to remove
staff view reporting as a routine task or
low-priority paperwork.
1. By providing feedback on the results of
investigation and problem resolution
2. Trending and analysis reports that lead
to changes in protocol, procedures, or
equipment based on these findings
fear the report is an admission of
negligence that exposes them to liability
and could be used against them in court
or for a punitive measure
1. incident report is not used as either a
punitive measure in disciplining
employees or a vehicle for airing
interpersonal disagreements.
2. The event itself may require disciplinary
action but not through the incident
reporting process
3. Training must stress that the report
should be a factual account of what
happened; no finger-pointing . Incident
reports are meant to collect “just the
facts,” .
16. Staff Participation in Incident
Reporting
Why incident reports may not be filed when policy directs staff to
do so ?
• Observer is too busy to complete the report when a narrative
section is required.
• Staff believe that reporting is of little value due to lack of
feedback.
• Staff fear disciplinary action based on the report.
• Non-physicians are reluctant to report incident involving
physicians.
• Staff are concerned that the report may lead to a lawsuit
leading to personal responsibility.
• Staff failed to recognize that an incident occurred.
• Staff do not understand the definition of an incident.
17. Occurrence Screening
• This system, utilizes a clearly defined list of patient
occurrences with which patient medical records are screened.
• It’s an example of 100% review system ,
• The screeners are looking for deviations from practice, policy,
and procedures.
• Criteria for the screens are established in areas that are
considered to be either :
1. high risk.
2. have a high number of incidents that have been reported
as quality of care “red flags” to be further evaluated.
3. areas where the effects of an untoward event occurring
can have disastrous results from an injury standpoint.
As an example :inappropriate informed consent documentation
18. Occurrence Screening
• In an inpatient setting, all patient records are
reviewed against the criteria within forty-eight to
seventy-two hours of admission and every three or
four days thereafter until the patient is discharged.
• The patient chart also is reviewed approximately
two weeks after discharge to ensure that
compliance with all criteria has been assessed.
• Results of this screening process are prepared for
each admission by trained data retrieval personnel
(screeners).
19. Occurrence Screening
• The abstract is then forwarded to the quality
improvement office for follow-up.
• When identified, serious occurrences are
reported immediately by the patient care
reviewers to the appropriate person for
action.
• All occurrences are aggregated to aid in
identifying any trends that reflect patient care
problems requiring remedial action.
• It’s concurrent (may be retrospective review).
20. Sentinel event
• an unexpected occurrence involving death or serious
physical or psychological injury.
• Serious injury includes loss of limb or function.
• Death or major permanent loss of function (sensory,
motor, physiologic, or intellectual), suicide, rape,
hemolytic transfusion reaction, Surgery/procedure on
the wrong patient or wrong body part, infant
abduction or infant discharge to the wrong family.
23. Root Cause Analysis
• Is a process done in response to
occurrence of sentinel event or near miss.
• The aim of root cause analysis is to
conduct intensive analysis to reach the
embedded problems in the system and
solve it.
24. RCA- Sequential steps
1- Define the problem
• Ask what is wrong, what is involved: conditions, activities,
materials.
• Ask when: day ,date, time, shift, time pattern, schedule.
• Ask where: site, area department, physical environment,
step in process.
• Ask how the what or who is affected, how much, how many,
work practice, omission / commission.
• Ask who is involved: patients, caregivers, other staff,
vendors, visitors.
• Review relevant documents.
• Consider other data collection options: surveys, observations,
interviews.
25. RCA- Sequential steps
2- perform task / process analysis
• divide a process into steps by sequencing
actions, instructions, conditions ,tools ,
and materials associated with the
performance of the task (flowchart).
• learn exactly what was supposed to
happen.
• contrast the baseline with what actually
happened (based on initial data
collection).
26. RCA- Sequential steps
3- perform change /different analysis:
• compare the task /steps successfully
performed to the same task /steps when
unsuccessful.
• analyze the difference.
• describe for each difference its effect on
the situation.
27. RCA- Sequential steps
4- perform control barriers/ safe guard analysis:
• analyze safeguards needed to prevent the event.
• analyze missing or ineffective safeguards.
Safeguards may be :
physical: safety equipment and devices; locks, walls.
Natural: distance and time (limited exposure).
information: caution such as labels , alarms.
knowledge: making information constantly available.
administrative: safety policies and procedures,
regulations, supervisory practices, training, education,
communication process.
28. RCA- Sequential steps
5- Begin cause and effect analysis
• List each undesirable step of the
occurrence
• considering each a primary effect
• using data collected to date , determine
what causes allowed or forced each effect
to occur
• show the relationship between each
cause and effect
29. RCA- Sequential steps
• continue the cause and effect analysis until :
Cause is outside the organization control
to correct.
Primary effect is fully explained.
No other causes can be found to explain
the effect.
Further analysis will yield no additional
benefit in correcting the problem.
• List all validated causes.
30. Healthcare FMEA Definitions
Healthcare Failure Mode & Effect
Analysis (HFMEA):
(1) A prospective assessment that
identifies and improves steps in a
process thereby reasonably ensuring
a safe and clinically desirable
outcome.
(2) A systematic approach to identify and
prevent product and process problems
before they occur.
31. Healthcare FMEA Definitions
Effective Control Measure:
A barrier that eliminates or substantially
reduces the likelihood of a hazardous
event occurring.
32. Healthcare FMEA Definitions
Hazard Analysis:
The process of collecting and evaluating
information on hazards associated with
the selected process. The purpose of
the hazard analysis is to develop a list
of hazards that are of such significance
that they are reasonably likely to cause
injury or illness if not effectively
controlled.
34. HFMEA Points Out System/Process
Vulnerabilities
A B C
Identified process
issue;
focus for intervention
35. The Healthcare Failure Modes
and Effects Process
Step 2 - Assemble the Team
Step 3 - Graphically Describe the Process
Step 4 - Conduct the Analysis
Step 5 - Identify Actions and Outcome Measures
Step 1- Define the Topic
36. Healthcare FMEA Process
STEP 1
Define the Scope of the HFMEA along
with a clear definition of the
process to be studied.
37. Healthcare FMEA Process
STEP 2
Assemble the Team –
Multidisciplinary team with Subject
Matter Expert(s) plus advisor
38. Healthcare FMEA Process
STEP 3 - Graphically Describe the Process
A. Develop and Verify the Flow Diagram (this
is a process vs. chronological diagram)
B. Consecutively number each process step
identified in the process flow diagram.
C. If the process is complex identify the area
of the process to focus on (manageable
bite)
39. Healthcare FMEA Process
STEP 3 - Graphically Describe the Process
D. Identify all sub processes under each block
of this flow diagram. Consecutively letter
these sub-steps.
E. Create a flow diagram composed of the sub
processes.
40. Healthcare FMEA Process
STEP 4 - Conduct a Hazard Analysis
A. List Failure Modes
B. Determine Severity & Probability
C. Use the Decision Tree
D. List all Failure Mode Causes
41. Healthcare FMEA Process
STEP 5 - Actions and Outcome Measures
A. Decide to “Eliminate,” “Control,” or “Accept”
the failure mode cause.
B. Describe an action for each failure mode
cause that will eliminate or control it.
C. Identify outcome measures that will be used
to analyze and test the re-designed process.
42. Healthcare FMEA Process
STEP 5 - Actions and Outcome Measures
D. Identify a single, responsible individual by
title to complete the recommended action.
E. Indicate whether top management has
concurred with the recommended actions.
43. Forms & Tools
Worksheets
Hazard Scoring Matrix
Decision Tree
Forms
44. Step 1. Select the process you want to examine.
Define the scope (Be specific and include a clear
definition of the process or product to be studied).
This HFMEA is focused on__________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
Healthcare FMEA Process
45. Step 2. Assemble the Team
FMEA Number_____________
Date Started ______________ Date Completed_____________
Team Members 1.__________________ 4.______________________
2.__________________ 5.______________________
3.__________________ 6.______________________
Team Leader ____________________________________
Are all affected areas represented? YES / NO
Are different levels and types of knowledge represented on the team? YES / NO
Who will take minutes and maintain records?____________________________
Healthcare FMEA Process
46. HFMEA WorksheetStep4
1 Process Step
2 Failure Mode
3 Cause
4 Severity
5 Probability
6 Hazard Score
7 Decision
Step5
8 Action (E,C,A)
9 Description of Action
10 Outcome Measure
11 Person Responsible
12 Management
Concurrence (Y/N)
47. HFMEA Decision Tree
The HFMEA Decision
Tree…
Does this hazard involve a sufficient
likelihood of occurrence and severity to
warrant that it be controlled?
(e.g. Hazard Score of 8 or higher)
Is the hazard so obvious and readily
apparent that a control measure is not
warranted?
(Detectability)
STOP
NO
YES
YES
PROCEED TO HFMEA
STEP 5
NO
Does an Effective Control Measure exist for the
identified hazard?
YES
NO
Is this a single point weakness in the
process?
(e.g. failure will result in system failure)
(Criticality)
YES
NO
48. HFMEA Decision Tree
1. Does this hazard involve a
sufficient likelihood of occurrence and
severity to warrant that it be
controlled?
(e.g. Hazard Score of 8 or higher)
YES NO
49. HFMEA Decision Tree
2. Is this a single point weakness
in the process?
(e.g. failure will result in system
failure)
(Criticality)
YES
NO
50. HFMEA Decision Tree
3. Does an Effective Control
Measure exist for the identified
hazard?
NO
STOP
YES
51. HFMEA Decision Tree
4. Is the hazard so obvious and
readily apparent that a control
measure is not warranted?
(Detectability)
NO
STOP
YES
PROCEED
52. SEVERITY RATING:
Hazard Analysis
Catastrophic Event
(Traditional FMEA Rating of 10 - Failure could
cause death or injury)
Major Event
(Traditional FMEA Rating of 7 – Failure causes a
high degree of customer dissatisfaction.)
Patient Outcome:Death or major permanent
loss of function (sensory, motor, physiologic, or
intellectual), suicide, rape, hemolytic transfusion
reaction, Surgery/procedure on the wrong patient
or wrong body part, infant abduction or infant
discharge to the wrong family
Visitor Outcome: Death; or hospitalization of 3
or more.
Staff Outcome: * A death or hospitalization of 3
or more staff
Equipment or facility: **Damage equal to or
more than $250,000
Fire: Any fire that grows larger than an incipient
Patient Outcome:Permanent lessening of bodily
functioning (sensory, motor, physiologic, or
intellectual), disfigurement, surgical intervention
required, increased length of stay for 3 or more
patients, increased level of care for 3 or more
patients
Visitor Outcome: Hospitalization of 1 or 2 visitors
Staff Outcome: Hospitalization of 1 or 2 staff or 3
or more staff experiencing lost time or restricted
duty injuries or illnesses
Equipment or facility: **Damage equal to or
more than $100,000
Fire: Not Applicable – See Moderate and
Catastrophic
53. SEVERITY RATING:
Hazard Analysis
Moderate Event
(Traditional FMEA Rating of “4” – Failure can
be overcome with modifications to the
process or product, but there is minor
performance loss.)
Minor Event
(Traditional FMEA Rating of “1”– Failure would
not be noticeable to the customer and would
not affect delivery of the service or product.)
Patient Outcome: Increased length of stay or
increased level of care for 1 or 2 patients
Visitor Outcome: Evaluation and treatment for
1 or 2 visitors (less than hospitalization)
Staff Outcome: Medical expenses, lost time or
restricted duty injuries or illness for 1 or 2 staff
Equipment or facility: **Damage more than
$10,000 but less than $100,000
Fire: Incipient stage‡ or smaller
Patients Outcome: No injury, nor increased length
of stay nor increased level of care
Visitor Outcome: Evaluated and no treatment
required or refused treatment
Staff Outcome: First aid treatment only with no
lost time, nor restricted duty injuries nor illnesses
Equipment or facility: **Damage less than
$10,000 or loss of any utility♦ without adverse
patient outcome (e.g. power, natural gas,
electricity, water, communications, transport,
heat/air conditioning).
Fire: Not Applicable – See Moderate and
Catastrophic
54. Hazard Analysis
PROBABILITY RATING:
Frequent - Likely to occur immediately or within a short
period (may happen several times in one year)
Occasional - Probably will occur (may happen several
times in 1 to 2 years)
Uncommon - Possible to occur (may happen sometime
in 2 to 5 years)
Remote - Unlikely to occur (may happen sometime in 5 to
30 years)
56. Example - Driving to Work
Decided to perform FMEA on driving to
work.
Want to include the processes associated
with this activity.
Meant as an illustrative example by
walking through the steps.
57. Step 1. Select the process you want to examine.
Define the scope (Be specific and include a clear
definition of the process or product to be studied).
This HFMEA is focused on__________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
Healthcare FMEA Process
58. Step 2. Assemble the Team
FMEA Number_____________
Date Started ______________ Date Completed_____________
Team Members 1.__________________ 4.______________________
2.__________________ 5.______________________
3.__________________ 6.______________________
Team Leader ____________________________________
Are all affected areas represented? YES / NO
Are different levels and types of knowledge represented on the team? YES / NO
Who will take minutes and maintain records?____________________________
Healthcare FMEA Process
59. Step 3A. Gather information about how the process
works – describe it graphically.
Teaching Example
Wake Up
Get
dressed
Start the
car
Drive the
car
Walk into
work
Park the
car
60. Step 3B. Consecutively number each process
Teaching Example
Wake Up
Get
dressed
Start the
car
Drive the
car
Walk into
work
Park the
car
61. Step 3C. If process is complex, choose area to focus
on.
Teaching Example
Wake Up
Get
dressed
Start the
car
Drive the
car
Walk into
work
Park the
car
62. Step 3D. If necessary, list sub-process steps and
consecutively number.
Teaching Example
Wake Up
Get
dressed
Start the
car
Drive the
car
Walk into
work
Park the
car
1A. Hit snooze
on alarm
1B. Again, hit
snooze on
alarm
1C. Get out of
bed
1D. Find fuzzy
slippers
2A. Get
coffee
2B. Take
shower
2C. Find
clean
clothes
2D. Find
shoes
3A. Find keys
3B. Find
wallet
3C. Look for
bag
3D. Look for
coffee
3E. Shovel
out car
4A. Coffee in
cupholder
4B. Bagel on
seat
4C. Listen to
traffic report
4D. Choose
route
5A. Notice
and take exit
5B.Negotiate
turn
5C. Find spot
5D. Get car to
turn off
6A. Collect
bag, coffee,
bagel
6B. Close
and lock
doors
6C. Begin
walking
6D. Return
for keys
63. Step 3D. Wake up (Sub-process flow diagram)
Teaching Example
1A. Hit
snooze
button
1C. Get
out of
bed
1D. Look
for fuzzy
slippers
1B. Again,
hit snooze
button
64. Step 4A. List all failure modes.
Teaching Example
1A. Hit
snooze
button
1C. Get
out of
bed
1D. Look
for fuzzy
slippers
1B. Again,
hit snooze
button
Failure Modes
1A(1) Turn off
alarm
1A(2) Unplug
Alarm
1A(3) Break
alarm clock
65. HFMEA Worksheet, Step 4AStep4
1 Process Step 1A. Hit snooze button
2 Failure Mode 1A(1). Turn off
alarm
3 Cause
4 Severity
5 Probability
6 Hazard Score
7 Decision
Step5
8 Action
9 Description of Action
10 Outcome Measure
11 Person Responsible
12 Management
Concurrence
66. HFMEA WorksheetStep4
1 Process Step 1A. Hit snooze button
2 Failure Mode 1A(1) Turn off
alarm
3 Cause
4 Severity
5 Probability
6 Hazard Score
7 Decision
Step5
8 Action (E,C,A)
9 Description of Action
10 Outcome Measure
11 Person Responsible
12 Management
Concurrence (Y/N)
67. Step 4B. Determine the Severity and Probability of each
potential cause. This will lead you to the Hazard Matrix Score.
SEVERITY RATING:
Step 4: Hazard Analysis
Catastrophic Event
(Traditional FMEA Rating of 10 - Failure could
cause death or injury)
Major Event
(Traditional FMEA Rating of 7 – Failure causes a
high degree of customer dissatisfaction.)
Patient Outcome : Death or major permanent
loss of function (sensory, motor, physiologic, or
intellectual), suicide, rape, hemolytic transfusion
reaction, Surgery/procedure on the wrong patient
or wrong body part, infant abduction or infant
discharge to the wrong family
Visitor Outcome: Death; or hospitalization of 3
or more.
Staff Outcome: * A death or hospitalization of 3
or more staff
Equipment or facility: **Damage equal to or
more than $250,000
Fire: Any fire that grows larger than an incipient
Patient Outcome:Permanent lessening of bodily
functioning (sensory, motor, physiologic, or
intellectual), disfigurement, surgical intervention
required, increased length of stay for 3 or more
patients, increased level of care for 3 or more
patients
Visitor Outcome: Hospitalization of 1 or 2 visitors
Staff Outcome: Hospitalization
of 1 or 2 staff or 3 or more staff experiencing lost
time or restricted duty injuries or illnesses
Equipment or facility: **Damage equal to or
more than $100,000
Fire: Not Applicable – See Moderate and
Catastrophic
68. Step 4. Determine the Severity and Probability of each
potential cause. This will lead you to the Hazard Matrix Score.
Step 4: Hazard Analysis
PROBABILITY RATING:
Occasional - Probably will occur (may happen several times
in 1 to 2 years)
Uncommon - Possible to occur (may happen sometime in 2
to 5 years)
Remote - Unlikely to occur (may happen sometime in 5 to 30
years)
Frequent - Likely to occur immediately or within a short period
(may happen several times in one year)
70. Step 4: HFMEA Decision Tree
1. Does this hazard involve a
sufficient likelihood of occurrence and
severity to warrant that it be
controlled?
(e.g. Hazard Score of 8 or higher)
YES NO
71. Step 4: HFMEA Decision Tree
2. Is this a single point weakness
in the process?
(e.g. failure will result in system
failure)
(Criticality)
YES
NO
72. Step 4: HFMEA Decision Tree
3. Does an Effective Control
Measure exist for the identified
hazard?
NO
STOP
YES
73. Step 4: HFMEA Decision Tree
4. Is the hazard so obvious and
readily apparent that a control
measure is not warranted?
(Detectability)
NO
STOP
YES
PROCEED
74. HFMEA Worksheet, Steps 4B & 4CStep4
1 Process Step 1A. Hit snooze button
2 Failure Mode 1aA(1). Turn off
alarm
3 Cause
4 Severity Major
5 Probability Occasional
6 Hazard Score 9
7 Decision Proceed (start listing
Causes)
Step5
8 Action (E,C,A)
9 Description of Action
10 Outcome Measure
11 Person Responsible
12 Management
Concurrence (Y/N)
75. HFMEA Worksheet, Step 5Step4
1 Process Step 1A. Hit snooze button
2 Failure Mode 1A(1). Turn off
alarm
3 Cause 1A(1)a. Missed
snooze button
4 Severity Major Major
5 Probability Occasional Occasional
6 Hazard Score 9 9
7 Decision Proceed (start
listing causes
Proceed
Step5
8 Action (E,C,A) Continue Analysis Eliminate
9 Description of Action Purchase new clock
10 Outcome Measure Purchase by x/xx/xx
11 Person Responsible YOU
12 Management
Concurrence (Y/N)
Yes
76. Step 3A. Gather information about how the process
works – describe it graphically.
HFMEA PSA Example
Process Step Process Step Process Step Process Step Process Step
PSA test
ordered
Draw
sample
Analyze
sample
Report to
physician
Result filed
(CPRS)
77. Step 3B. Consecutively number each process step.
HFMEA PSA Example
PSA test
ordered
Draw
sample
Analyze
sample
Report to
physician
Result filed
(CPRS)
78. Step 3C. If process is complex, choose area to focus
on.
HFMEA PSA Example
PSA test
ordered
Draw
sample
Analyze
sample
Report to
physician
Result filed
(CPRS)
79. Step 3D. If necessary, list sub-process steps and
consecutively number.
HFMEA PSA Example
Sub-processes:
A. Order written
B. Entered in
CPRS
C. Received in
lab
Sub-processes:
A. ID patient
B. Select proper
tube/equip.
C. Draw blood
D. Label blood
Sub-processes:
A. Review order
B. Centrifuge
Specimen
C. Verify
Calibration
D. Run QC
E. Run sample
F. Report result
G. Enter in CPRS
Sub-processes:
A. Report
received
Sub-processes:
A. Telephone
B. Visit set up
C. Result given
PSA test
ordered
Draw
sample
Analyze
sample
Report to
physician
Result filed
(CPRS)
80. Step 3E. Analyze Sample (Sub-process flow diagram)
HFMEA PSA Example
3A.
Review
order
3B.
Centrifuge
specimen
3C.
Verify
calibration
3D.
Run QC
3F.
Report
result
3E.
Run
sample
3G.
Enter in
CPRS
81. Step 4A. Hazard Analysis: List potential failure
modes for each process step.
HFMEA PSA Example
Failure Mode:
1.Wrong test
ordered
2.Order not
received
Failure Mode:
1.Equip. broken
2.Wrong speed
3.Specimen not
clotted
4.No power
5.Wrong test
tube
Failure Mode:
1.Instr not
calibrated
2.Bad
calibration
stored
Failure Mode:
1.QC results
unacceptable
Failure Mode:
1.Mechanical
error
2.Tech error
Failure Mode:
1.Computer crash
2.Result entered
for wrong pt.
3.Computer
transcription
error
4.Result not
entered
5.Result mis-
read by tech
Review
order
Centrifuge
specimen
Verify
calibra-
tion
Run QC Report
result
Run
Sample
Enter
result
(CPRS)
82. Step 4B,C, D. Determine hazard score and list all the potential
causes for each potential failure mode.
HFMEA PSA Example
Process
Step
(3F) Report result
Failure
Mode
(3F1) Computer
crash
Potential
Cause
(3F1a ) Virus (3F1b) Old
equipment
(3F1c) Software
license expired
Severity Major Major Moderate Moderate
Probability Occasional Occasional Remote Occasional
HazardScor
e
9 9 2 6
Decision Proceed Proceed Stop Stop
Action
Description
of Action
83. Step 4: HFMEA Decision Tree
1. Does this hazard involve a
sufficient likelihood of occurrence and
severity to warrant that it be
controlled?
(e.g. Hazard Score of 8 or higher)
YES NO
84. Step 4: HFMEA Decision Tree
2. Is this a single point weakness
in the process?
(e.g. failure will result in system
failure)
(Criticality)
YES
NO
85. Step 4: HFMEA Decision Tree
3. Does an Effective Control
Measure exist for the identified
hazard?
NO
STOP
YES
86. Step 4: HFMEA Decision Tree
4. Is the hazard so obvious and
readily apparent that a control
measure is not warranted?
(Detectability)
NO
STOP
YES
PROCEED
87. Step 4B,C, D. Determine hazard score and list all the potential
causes for each potential failure mode.
HFMEA PSA Example
Process
Step
(3F) Report result
Failure
Mode
(3F1) Computer
crash
Potential
Cause
(3F1a ) Virus (3F1b) Old
equipment
(3F1c) Software
license expired
Severity Major Major Moderate Moderate
Probability Occasional Occasional Remote Occasional
HazardScor
e
9 9 2 6
Decision Proceed Proceed Stop Stop
Action
Description
of Action
Outcome
88. HFMEA PSA Example
Process
Step
(3F) Report result
Failure
Mode
(3F5) Tech mis-
reads result
Potential
Cause
(3F5a) Tech
fatigue
(3F5b) Too busy (3F5c) Poor
lighting
(3F5d) Confusing
readout on PSA
instr.
Severity Moderate Moderate Moderate Moderate Moderate
Probability Frequent Frequent Frequent Remote Frequent
Haz Score 8 8 8 2 8
Decision Proceed Stop Proceed Stop Proceed
Action C E
Description
of Action
Hire tech New equipment
Outcome
Measure
Staff increased New equip. on
site
Person
Responsibl
e
Chief, PALMS Chief, PALMS
Mgt
Concur
(y/n)
Y Y