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Tools to Identify and Control Patient Safety Risks
Dr. Mohamed Mosaad Hasan
CQI/ PS Specialist
Risk Identification.
•Training video
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.
Systems for Risk IdentificationInformal 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
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
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.
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.
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
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,”
Incident report
Socioeconomic data
Facility-related information
Demographic information
Description of the incident,
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.
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.
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
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 )
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.
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,” .
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.
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
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).
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).
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.
Response to sentinel event
Root cause analysis
Sentinel Events
• Rosie King’s video
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.
RCA- Sequential steps1- 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.
RCA- Sequential steps2- 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).
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.
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.
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
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.
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.
Healthcare FMEA Definitions
Effective Control Measure:
A barrier that eliminates or substantially reduces the likelihood of a hazardous event occurring.
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.
Healthcare FMEA Definitions
Failure Mode:
Different ways that a process or sub-process can fail to provide the anticipated result.
HFMEA Points Out System/Process Vulnerabilities
A B C
Identified process
issue;
focus for intervention
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
Healthcare FMEA Process
STEP 1
Define the Scope of the HFMEA along
with a clear definition of the process to be studied.
Healthcare FMEA Process
STEP 2
Assemble the Team – Multidisciplinary
team with Subject Matter Expert(s) plus advisor
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)
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.
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
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.
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.
Forms & Tools
Worksheets
Hazard Scoring Matrix
Decision Tree
Forms
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
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
HFMEA Worksheet
Step 4
1 Process Step
2 Failure Mode
3 Cause
4 Severity
5 Probability
6 Hazard Score
7 Decision
Step 5
8 Action (E,C,A)
9 Description of Action
10 Outcome Measure
11 Person Responsible
12 Management Concurrence (Y/N)
HFMEA Decision Tree
The HFMEA Decision Tree…
Does this hazard involve a sufficientlikelihood of occurrence and severity to
warrant that it be controlled?(e.g. Hazard Score of 8 or higher)
Is the hazard so obvious and readilyapparent that a control measure is not
warranted?(Detectability)
STOP
NO
YES
YES
PROCEED TO HFMEASTEP 5
NO
Does an Effective Control Measure exist for theidentified hazard?
YES
NO
Is this a single point weakness in theprocess?
(e.g. failure will result in system failure)(Criticality)
YES
NO
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
HFMEA Decision Tree
2. Is this a single point weakness in the process?(e.g. failure will result in system failure)(Criticality)
YES
NO
HFMEA Decision Tree
3. Does an Effective Control Measure exist for the identified hazard?
NOSTOP
YES
HFMEA Decision Tree
4. Is the hazard so obvious and readily apparent that a control measure is not warranted?(Detectability)
NOSTOP
YES
PROCEED
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 patientsVisitor Outcome: Hospitalization of 1 or 2 visitorsStaff 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 $100,000Fire: Not Applicable – See Moderate and Catastrophic
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 patientsVisitor 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 staffEquipment or facility: **Damage more than $10,000 but less than $100,000Fire: Incipient stage‡ or smaller
Patients Outcome: No injury, nor increased length of stay nor increased level of careVisitor Outcome: Evaluated and no treatment required or refused treatmentStaff Outcome: First aid treatment only with no lost time, nor restricted duty injuries nor illnessesEquipment 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
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)
HFMEA Hazard Scoring Matrix
Pro
bability
Severity
Catastrophic Major Moderate Minor
Frequent 16 12 8 4
Occasional 12 9 6 3
Uncommon 8 6 4 2
Remote 4 3 2 1
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.
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
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
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
Step 3B. Consecutively number each process
Teaching Example
Wake Up Get dressed
Start the car
Drive the car
Walk into work
Park the car
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
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
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
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
HFMEA Worksheet, Step 4A
Step 4
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
Step 5
8 Action
9 Description of Action
10 Outcome Measure
11 Person Responsible
12 Management Concurrence
HFMEA Worksheet
Step 4
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
Step 5
8 Action (E,C,A)
9 Description of Action
10 Outcome Measure
11 Person Responsible
12 Management Concurrence (Y/N)
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 patientsVisitor Outcome: Hospitalization of 1 or 2 visitorsStaff Outcome: Hospitalizationof 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 $100,000Fire: Not Applicable – See Moderate and Catastrophic
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)
HFMEA Hazard Scoring Matrix
Probability
Severity
Catastrophic Major Moderate Minor
Frequent 16 12 8 4
Occasional 12 9 6 3
Uncommon 8 6 4 2
Remote 4 3 2 1
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
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
Step 4: HFMEA Decision Tree
3. Does an Effective Control Measure exist for the identified hazard?
NOSTOP
YES
Step 4: HFMEA Decision Tree
4. Is the hazard so obvious and readily apparent that a control measure is not warranted?(Detectability)
NOSTOP
YES
PROCEED
HFMEA Worksheet, Steps 4B & 4C
Step 4
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)
Step 5
8 Action (E,C,A)
9 Description of Action
10 Outcome Measure
11 Person Responsible
12 Management Concurrence (Y/N)
HFMEA Worksheet, Step 5Step 4
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
Step 5
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
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)
Step 3B. Consecutively number each process step.
HFMEA PSA Example
PSA test ordered
Draw sample
Analyze sample
Report to physician
Result filed (CPRS)
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)
Step 3D. If necessary, list sub-process steps and consecutively number.
HFMEA PSA Example
Sub-processes:
A. Order writtenB. Entered in CPRSC. Received in lab
Sub-processes:
A. ID patientB. Select propertube/equip.C. Draw bloodD. Label blood
Sub-processes:
A. Review orderB. CentrifugeSpecimenC. VerifyCalibrationD. Run QCE. Run sampleF. Report resultG. Enter in CPRS
Sub-processes:
A. Report received
Sub-processes:
A. TelephoneB. Visit set upC. Result given
PSA test ordered
Draw sample
Analyze sample
Report to physician
Result filed (CPRS)
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
Step 4A. Hazard Analysis: List potential failuremodes for each process step.
HFMEA PSA Example
Failure Mode:
1.Wrong testordered2.Order notreceived
Failure Mode:
1.Equip. broken2.Wrong speed3.Specimen notclotted4.No power5.Wrong test tube
Failure Mode:
1.Instr not calibrated2.Bad calibrationstored
Failure Mode:
1.QC results unacceptable
Failure Mode:
1.Mechanicalerror2.Tech error
Failure Mode:
1.Computer crash2.Result entered for wrong pt.3.Computertranscription error4.Result notentered5.Result mis-read by tech
Review order
Centrifuge specimen
Verify calibra-tion
Run QC Report result
Run Sample
Enter result (CPRS)
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
HazardScore
9 9 2 6
Decision Proceed Proceed Stop Stop
Action
Description of Action
Outcome Measure
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
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
Step 4: HFMEA Decision Tree
3. Does an Effective Control Measure exist for the identified hazard?
NOSTOP
YES
Step 4: HFMEA Decision Tree
4. Is the hazard so obvious and readily apparent that a control measure is not warranted?(Detectability)
NOSTOP
YES
PROCEED
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
HazardScore
9 9 2 6
Decision Proceed Proceed Stop Stop
Action
Description of Action
Outcome Measure
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 Responsible
Chief, PALMS Chief, PALMS
Mgt Concur (y/n)
Y Y