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Risk Evaluation

Overview

You can also download a tabular version of this Risk Evaluation Table in the *.csv format.

Lookup Matrices

Probability

P1 (Probability of the Hazardous Situation Occurring) × P2 (Probability of the Hazardous Situation Leading to Harm) = Probability

Semi-Qualitative Probability Levels – Common Terms and Descriptors

  • 5 = Frequent - Occurs more than 1 in 10 (likely to happen, often, frequent)
  • 4 = Probable - Between 1 in 10 and 1 in 100
  • 3 = Occasional - Between 1 in 100 and 1 in 1,000 (can happen, but not frequently)
  • 2 = Remote - Between 1 in 1,000 and 1 in 10,000
  • 1 = Improbable - Less than 1 in 10,000 (unlikely to happen, rare, remote)
P1 \ P2 1 - Improbable 2 - Remote 3 - Occasional 4 - Probable 5 - Frequent
1 - Improbable 1 - Improbable 1 - Improbable 2 - Remote 2 - Remote 3 - Occasional
2 - Remote 1 - Improbable 2 - Remote 2 - Remote 3 - Occasional 3 - Occasional
3 - Occasional 2 - Remote 2 - Remote 3 - Occasional 4 - Probable 4 - Probable
4 - Probable 2 - Remote 3 - Occasional 4 - Probable 4 - Probable 5 - Frequent
5 - Frequent 3 - Occasional 3 - Occasional 4 - Probable 5 - Frequent 5 - Frequent

Risk Level

S (Severity) × P (Probability) = Risk Level

Qualitative Severity Levels – Common Terms and Descriptors

  • 5 = Catastrophic Results in (or Potential of) death.
  • 4 = Critical Results in (or Potential of) permanent impairment or life-threatening injury (excluding trivial impairment).
  • 3 = Major Results in (or Potential of) injury or impairment requiring professional medical intervention.
  • 2 = Minor Results in temporary injury or impairment not requiring professional medical intervention.
  • 1 = Negligible Inconvenience or temporary discomfort.
P \ S 1 - Negligible 2 - Minor 3 - Serious 4 - Critical 5 - Catastrophic
1 - Improbable Low Low Low Low Medium
2 - Remote Low Low Medium Medium Medium
3 - Occasional Low Medium Medium Medium High
4 - Probable Low Medium Medium High High
5 - Frequent Medium Medium High High High

Risk Evaluation Table

Name Hazard Sequence of Events Hazardous Situation Harm Severity P1 (Probability of the Hazardous Situation Occurring) P2 (Probability of the Hazardous Situation Leading to Harm) Ptotal = P1 x P2 Initial Risk Level Initial Risk Acceptability Risk Control Required?
TC contaminates environment with amplicon Biological Agents
  1. TC seal fails on positive test run
  2. TC amplicons escape to environment
 Environment exposed to amplicon Future false positive results 3 - Serious 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
SCC contaminates environment with sample Biological Agents
  1. SCC collects sample from an infectious patient
  2. SCC touches objects in environment before transfer into STC or handle touches objects in environment after separation from head in STC
 Person exposed to sample Disease transmission 3 - Serious 2 - Remote 3 - Occasional 2 - Remote Medium Unacceptable Undetermined
SCC is reused Biological Agents
  1. SCC collects sample from an infectious patient
  2. SCC collects sample from a different patient
 Person exposed to sample Disease transmission 3 - Serious 1 - Improbable 5 - Frequent 3 - Occasional Medium Unacceptable Undetermined
STC contaminates environment with sample Biological Agents
  1. SCC collects sample from an infectious patient
  2. SCC transfers sample into STC
  3. STC spills sample onto workspace or person
 Person exposed to sample Disease transmission 3 - Serious 2 - Remote 3 - Occasional 2 - Remote Medium Unacceptable Undetermined
STC is reused Biological Agents
  1. STC with remnants of sample from an infectious patient is re-opened
 Person exposed to sample Disease transmission 3 - Serious 1 - Improbable 1 - Improbable 1 - Improbable Low Acceptable Undetermined
SPM contaminates environment with sample Biological Agents
  1. a. SPM containment fails during operation or b. STC containment fails inside SPM during operation
  2. SPM shakes infectious sample into the environment
 Person exposed to sample Disease transmission 3 - Serious 2 - Remote 4 - Probable 3 - Occasional Medium Unacceptable Undetermined
SPM does not inactivate sample Biological Agents
  1. a. SPM is mis-calibrated or b. SPM software fails or c. SPM electronics fail
  2. SPM appears to heat and shake but fails to inactivate sample in STC
  3. STC allows transfer of infectious sample to person
 Person exposed to sample Disease transmission 3 - Serious 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
SCC is contaminated with manufacturing chemicals Chemical Agents
  1. SCC is contaminated with chemicals during manufacture
  2. SCC is used to collect sample from person and transfers chemicals to sampling site on person
 Patient exposed to chemicals Toxicity 3 - Serious 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
TC reagents are inhibited by manufacturing chemicals Diagnostic Information
  1. TC is contaminated with chemicals during manufacture
  2. TC reagents do not work in the presence of the chemical or its residue
 Patient receives invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
PM does not amplify Diagnostic Information
  1. a. PM amplification heaters are mis-calibrated or b. PM software fails or c. PM electronics fail
  2. PM appears to heat during amplification but fails to amplify sample in TC
 Patient receives invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
PM does not open valve Diagnostic Information
  1. a. PM valve heater is mis-calibrated or b. PM software fails or c. PM electronics fail
  2. PM appears to heat during valving but fails to allow flow to detection in TC
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
SCC is contaminated by environment Diagnostic Information
  1. SCC collects MTb from the environment
  2. SCC is used to collect a negative sample
 Patient receives false positive result Incorrect diagnosis 3 - Serious 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
SCC is never added to STC Diagnostic Information
  1. SCC is never added to STC
 Patient receives false negative result Incorrect diagnosis 4 - Critical 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
STC is contaminated by environment Diagnostic Information
  1. STC collects MTb from the environment
  2. STC is used to process a negative sample
 Patient receives false positive result Incorrect diagnosis 3 - Serious 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
STC is opened and left exposed to environment Diagnostic Information
  1. STC is left open until liquid reagents evaporate
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 3 - Occasional 2 - Remote Low Acceptable Undetermined
STC is removed from SPM during operation Diagnostic Information
  1. STC with positive sample is removed early from SPM
  2. STC transfers insufficiently lysed sample to TC
  3. TC fails to amplify insufficiently lysed sample
 Patient receives false negative result Incorrect diagnosis 4 - Critical 1 - Improbable 3 - Occasional 2 - Remote Medium Unacceptable Undetermined
STC sample transfer into TC introduces air bubbles Diagnostic Information
  1. STC sample transfer introduces air bubbles into TC
  2. TC fails fluidically because of bubbles
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 2 - Remote 2 - Remote 2 - Remote Low Acceptable Undetermined
STC sample transfer into TC is delayed Diagnostic Information
  1. STC sample transfer of a positive sample into TC is delayed
  2. STC sample degrades
  3. TC fails to amplify degraded positive sample
 Patient receives false negative result Incorrect diagnosis 4 - Critical 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
STC sample transfer into TC leaks Diagnostic Information
  1. STC sample transfer into TC leaks
  2. TC fails fluidically because of insufficient fluid volume
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 3 - Occasional 2 - Remote Low Acceptable Undetermined
TC amplification reagents fail during storage Diagnostic Information
  1. TC amplification reagents fail during storage
  2. TC fails to amplify positive sample
 Patient receives invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
TC detection reagents fail during storage Diagnostic Information
  1. TC detection reagents fail during storage
  2. TC fails to detect positive amplicons
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
TC is contaminated by environment Diagnostic Information
  1. TC collects MTb from the environment
  2. TC is used to test a negative sample
 Patient receives false positive result Incorrect diagnosis 3 - Serious 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
TC is exposed to amplicon during manufacturing Diagnostic Information
  1. TC collects amplicon during manufacture
  2. TC is used to test a negative sample
 Patient receives false positive result Incorrect diagnosis 3 - Serious 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
TC is loaded into PM in wrong orientation Diagnostic Information
  1. TC is loaded into PM in wrong orientation
  2. TC amplification and valve zones are not heated by the PM
  3. TC fails to return a result
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
TC is opened and left exposed to environment Diagnostic Information
  1. TC is opened and left to sit
  2. TC reagents are partially rehydrated and degrade under environmental conditions
  3. TC is used to test a positive sample
 Patient receives invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
TC is removed from PM during operation Diagnostic Information
  1. TC is removed from PM during operation
  2. TC valve is not heated by PM and does not open
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
TC is reused Diagnostic Information
  1. TC run on positive sample is re-opened
  2. TC amplicons escape to environment
 Environment exposed to amplicon Future false positive results 3 - Serious 1 - Improbable 3 - Occasional 2 - Remote Medium Unacceptable Undetermined
TC test and control lines show non-specific binding Diagnostic Information
  1. TC is run on a negative sample
  2. TC test and control lines show non-specific binding
 Patient receives false positive result Incorrect diagnosis 3 - Serious 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
TC valve never opens Diagnostic Information
  1. TC valve never opens
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
TC valve opens early Diagnostic Information
  1. TC is run on a positive sample
  2. TC valve opens too early for target amplification but late enough for IPC amplification
 Patient receives false negative result Incorrect diagnosis 4 - Critical 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
PM batteries overcharge Electric Energy
  1. PM batteries overcharge, heat up, and catch fire
 Operator exposed to fire Burn 3 - Serious 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
PM batteries over-discharge Electric Energy
  1. PM batteries over-discharge
  2. PM can no longer hold a charge
 Operator unable to use PM Delayed diagnosis 1 - Negligible 1 - Improbable 4 - Probable 2 - Remote Low Acceptable Undetermined
PM electrical components fail Electric Energy
  1. PM electrical component is of insufficient quality and fails
 Operator unable to use PM Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
PM experiences electrostatic discharge Electric Energy
  1. PM is touched by person carrying electrostatic charge
  2. PM electronics are damaged by resulting discharge
 Operator unable to use PM Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
PM experiences electrical interference Electric Energy
  1. PM experiences hardware failure due to voltage and electrical noise caused by nearby EM waves
 Operator unable to use PM Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
PM is dropped and breakage exposes electrical circuits Electric Energy
  1. PM is dropped and breakage exposes electrical circuits
 Operator exposed to electricity Electrical shock 2 - Minor 2 - Remote 2 - Remote 2 - Remote Low Acceptable Undetermined
PM is plugged in to faulty power supply Electric Energy
  1. PM is plugged in to faulty power supply
  2. PM electronics overdraw current and catch fire
 Operator exposed to fire Burn 3 - Serious 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
PM is unplugged during operation on insufficient battery charge Electric Energy
  1. PM is unplugged during operation on insufficient battery charge
  2. PM dies during TC operation
  3. TC is invalid
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
PM placed near magnetic field Electric Energy
  1. PM is placed near magnetic field that triggers lid sensor while lid is open
  2. PM amplification and valve heaters turn on while exposed
 Operator exposed to heater Burn 2 - Minor 1 - Improbable 3 - Occasional 2 - Remote Low Acceptable Undetermined
PM wires are exposed Electric Energy
  1. PM internal wiring or power cord insulation breaks down
  2. PM exposed wiring energizes ungrounded enclosure
  3. PM enclosure is touched
 Operator exposed to electricity Electrical shock 2 - Minor 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
STC leaks fluid into SPM Electric Energy
  1. STC leaks while in SPM
  2. SPM electronics are shorted by leaking fluid and catch fire
 Operator exposed to fire Burn 3 - Serious 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
SPM batteries overcharge Electric Energy
  1. SPM batteries overcharge, heat up, and catch fire
 Operator exposed to fire Burn 3 - Serious 1 - Improbable 4 - Probable 2 - Remote Medium Unacceptable Undetermined
SPM batteries over-discharge Electric Energy
  1. SPM batteries over-discharge
  2. SPM can no longer hold a charge
 Operator unable to use SPM Delayed diagnosis 1 - Negligible 1 - Improbable 4 - Probable 2 - Remote Low Acceptable Undetermined
SPM electrical components fail Electric Energy
  1. SPM electrical component is of insufficient quality and fails
 Operator unable to use SPM Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
SPM experiences electrostatic discharge Electric Energy
  1. SPM is touched by person carrying electrostatic charge
  2. SPM electronics are damaged by resulting discharge
 Operator unable to use SPM Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
SPM experiences electrical interference Electric Energy
  1. SPM experiences hardware failure due to voltage and electrical noise caused by nearby EM waves
 Operator unable to use SPM Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
SPM is dropped and breakage exposes electrical circuits Electric Energy
  1. SPM is dropped and breakage exposes electrical circuits
 Operator exposed to electricity Electrical shock 2 - Minor 2 - Remote 2 - Remote 2 - Remote Low Acceptable Undetermined
SPM is plugged in to faulty power supply Electric Energy
  1. SPM is plugged in to faulty power supply
  2. SPM electronics overdraw current and catch fire
 Operator exposed to fire Burn 3 - Serious 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
SPM is unplugged during operation on insufficient battery charge Electric Energy
  1. SPM is unplugged during operation on insufficient battery charge
  2. SPM dies during STC operation
  3. STC contains a positive sample that is insufficiently lysed
 Patient receives false negative result Incorrect diagnosis 4 - Critical 1 - Improbable 5 - Frequent 3 - Occasional Medium Unacceptable Undetermined
SPM placed near magnetic field Electric Energy
  1. SPM is placed near magnetic field that triggers lid sensor while lid is open
  2. SPM shakes while exposed
 Operator exposed to moving parts Physical trauma 2 - Minor 1 - Improbable 3 - Occasional 2 - Remote Low Acceptable Undetermined
SPM wires are exposed Electric Energy
  1. SPM internal wiring or power cord insulation breaks down
  2. SPM exposed wiring energizes ungrounded enclosure
  3. SPM enclosure is touched
 Operator exposed to electricity Electrical shock 2 - Minor 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
PM is dropped on person Mechanical Energy
  1. PM is dropped on person
 Person hit by PM Physical trauma 2 - Minor 1 - Improbable 3 - Occasional 2 - Remote Low Acceptable Undetermined
PM magnetic closure pinches Mechanical Energy
  1. PM lid is closed on fingers and magnetic closure causes pinch
 Operator pinches fingers Physical trauma 2 - Minor 2 - Remote 2 - Remote 2 - Remote Low Acceptable Undetermined
SPM connector fails during shaking Mechanical Energy
  1. SPM connecter fails mechanically
  2. SPM is unusable
 Operator unable to use SPM Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
SPM is dropped on person Mechanical Energy
  1. SPM is dropped on person
 Person hit by PM Physical trauma 2 - Minor 1 - Improbable 3 - Occasional 2 - Remote Low Acceptable Undetermined
SPM loses control of shaker Mechanical Energy
  1. SPM shaker control fails
  2. SPM shakes even when lid is open
 Operator exposed to moving parts Physical trauma 2 - Minor 1 - Improbable 3 - Occasional 2 - Remote Low Acceptable Undetermined
SPM observation window breaks Mechanical Energy
  1. SPM observation window breaks
 Operator exposed to moving/sharp parts Physical trauma 2 - Minor 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
SPM magnetic closure pinches Mechanical Energy
  1. SPM lid is closed on fingers and magnetic closure causes pinch
 Operator pinches fingers Physical trauma 2 - Minor 2 - Remote 2 - Remote 2 - Remote Low Acceptable Undetermined
SPM shakes while open Mechanical Energy
  1. SPM fails to stop shaking when lid is opened
 Operator exposed to moving parts Physical trauma 2 - Minor 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
SPM vibrates off of surface during shaking Mechanical Energy
  1. SPM vibrates off surface during shaking and falls on a person
 Person hit by PM Physical trauma 2 - Minor 2 - Remote 3 - Occasional 2 - Remote Low Acceptable Undetermined
System damaged by shipping Mechanical Energy
  1. System is inadequately packed and is unusable at customer site
 Operator unable to use system Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
TC is dropped Mechanical Energy
  1. TC is dropped after sample introduction from STC
  2. TC sample is displaced on impact and causes air blockage and fluidic failure
 Operator obtains invalid result Delayed diagnosis 1 - Negligible 1 - Improbable 5 - Frequent 3 - Occasional Low Acceptable Undetermined
PM lid fails under thermal stress Thermal Energy
  1. PM is operated repeatedly
  2. PM lid fails because of thermal stress on material above heater
  3. PM heater is exposed through lid
 Operator exposed to heater Burn 2 - Minor 4 - Probable 3 - Occasional 4 - Probable Medium Unacceptable Undetermined
PM loses control of heater Thermal Energy
  1. PM heater control fails
  2. PM heats uncontrollably until it catches fire
 Operator exposed to fire Burn 3 - Serious 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
PM valve heater is exposed to touch at max temp Thermal Energy
  1. PM lid is opened during operation
 Operator exposed to heater Burn 2 - Minor 2 - Remote 3 - Occasional 2 - Remote Low Acceptable Undetermined
STC melts during heating in SPM Thermal Energy
  1. STC is operated in SPM
  2. STC melts onto electronics, and they catch fire
 Operator exposed to fire Burn 3 - Serious 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined
SPM loses control of heater Thermal Energy
  1. SPM heater control fails
  2. SPM heats uncontrollably until it catches fire
 Operator exposed to fire Burn 3 - Serious 1 - Improbable 2 - Remote 1 - Improbable Low Acceptable Undetermined