Assay workflow FMEA

// Trace assay workflow failures, from sample misidentification to pseudoreplication, from cause to effect and mitigation; compare ordinal risk priorities without interpreting them as probabilities.
// Synthetic worked example: all entities, schedules and measurements are illustrative.
// Every string below is EXAMPLE text from a fictional model: replace it.
// Replace assumptions and inputs before applying this model to actual work.

fmea assessment {
  title: "Illustrative Assay workflow FMEA"
  system: "Assay workflow FMEA"
  team: "Cross-functional review"
  revision: "Workshop example"
}

failure_mode failure_0 {
  component: "Sample label"
  mode: "Misidentification"
  cause: "Manual label transcription"
  effect: "Measurement attributed incorrectly"
  severity: 8
  occurrence: 3
  detection: 6
}

mitigation mitigation_0 {
  mode: failure_0
  action: "Scan immutable sample identifiers"
  owner: "Assign accountable reviewer"
  target_severity: 8
  target_occurrence: 2
  target_detection: 3
}

failure_mode failure_1 {
  component: "Blank control"
  mode: "Background ignored"
  cause: "Blank omitted from batch"
  effect: "Signal overestimated"
  severity: 7
  occurrence: 4
  detection: 4
}

mitigation mitigation_1 {
  mode: failure_1
  action: "Require batch-specific blank measurement"
  owner: "Assign accountable reviewer"
  target_severity: 7
  target_occurrence: 2
  target_detection: 3
}

failure_mode failure_2 {
  component: "Calibration"
  mode: "Range exceeded"
  cause: "Sample above calibration maximum"
  effect: "Reported concentration unreliable"
  severity: 6
  occurrence: 3
  detection: 5
}

mitigation mitigation_2 {
  mode: failure_2
  action: "Flag and dilute out-of-range samples"
  owner: "Assign accountable reviewer"
  target_severity: 6
  target_occurrence: 2
  target_detection: 3
}

failure_mode failure_3 {
  component: "Replicate handling"
  mode: "Pseudoreplication"
  cause: "Technical repeats counted independently"
  effect: "Uncertainty understated"
  severity: 9
  occurrence: 2
  detection: 7
}

mitigation mitigation_3 {
  mode: failure_3
  action: "Track biological and technical replicate levels"
  owner: "Assign accountable reviewer"
  target_severity: 9
  target_occurrence: 2
  target_detection: 3
}

view priorities: fmea_table