Clinical Laboratory Risk Assessment Report
Generated: | Tool: labtestacademy.com/occupational-health-and-safety-risk-assessment/
Clinical Laboratory Risk Assessment Tool
FMEA-based scoring framework aligned with ISO 15189:2022, ISO 22367:2020 & ISO 31000:2018.
Rate each risk using Severity, Occurrence, and Detection scores to calculate the Risk Priority Number (RPN).
Risks Scored
0
Unacceptable >10
0
Tolerable 5–10
0
Acceptable <5
0
Average RPN
—
Acceptable — RPN <5 (routine controls; annual review)
Tolerable — RPN 5–10 (controls required; action within 30 days)
Unacceptable — RPN >10 (immediate action before work continues)
Exception: Severity = 5 → always Unacceptable regardless of RPN
📋 Scoring Reference Guide — click to expand
Severity (S) — Patient / Lab Impact
1 Negligible — no patient impact, no lab disruption
2 Mild — minor inconvenience, easily corrected
3 Moderate — delayed or slightly incorrect treatment
4 Severe — significant patient harm, serious lab impact
5 Catastrophic — patient death or permanent harm ⚠
Occurrence (O) — How Often It Happens
1 Rare — less than once per year
2 Occasional — about once per month
3 Moderate — about once per week
4 Frequent — a few times per week
5 Very frequent — daily occurrence
Detection (D) — How Hard to Catch
1 Very easy — always detected before harm
2 Easy — usually detected, rarely missed
3 Moderate — sometimes missed by existing checks
4 Difficult — rarely detected in time
5 Almost impossible — failure reaches patient undetected
⚠ Important: Detection scoring is counterintuitive. A low score (1) means you have strong detection controls (good!). A high score (5) means the failure is nearly impossible to catch before it causes harm (dangerous!). Always ask: "Do we have a system in place that would catch this failure?"
Export / Report
Frequently Asked Questions
Everything you need to know about using this FMEA-based risk assessment tool for ISO 15189:2022 compliance.
What is FMEA and how does this tool use it?
Failure Mode and Effect Analysis (FMEA) is a systematic, proactive risk assessment technique used to identify potential failure modes in a process, assess their consequences, and prioritize corrective actions.
This tool applies FMEA to clinical laboratory workflows by scoring each identified risk across three dimensions:
The product of these three scores — S × O × D = RPN — gives the Risk Priority Number, which guides your mitigation priorities.
This tool applies FMEA to clinical laboratory workflows by scoring each identified risk across three dimensions:
- Severity (S) — how severe is the impact on patients or the lab if this failure occurs?
- Occurrence (O) — how frequently is this failure likely to happen?
- Detection (D) — how difficult is it to detect this failure before it causes harm?
The product of these three scores — S × O × D = RPN — gives the Risk Priority Number, which guides your mitigation priorities.
How do I interpret the RPN thresholds?
The tool uses the following RPN classification aligned with ISO 22367:2020 risk acceptability criteria:
Important exception: Any risk scored Severity = 5 (Catastrophic) is automatically considered Unacceptable regardless of the RPN value, because the potential for patient death or permanent harm cannot be tolerated at any frequency.
- Acceptable RPN < 5 — Risk is acceptable. Maintain routine controls and schedule annual review.
- Tolerable RPN 5–10 — Risk is tolerable but requires documented controls and a corrective action plan within 30 days.
- Unacceptable RPN > 10 — Risk is unacceptable. Immediate action is required before work can continue in that process area.
Important exception: Any risk scored Severity = 5 (Catastrophic) is automatically considered Unacceptable regardless of the RPN value, because the potential for patient death or permanent harm cannot be tolerated at any frequency.
Which ISO standards does this tool align with?
This tool is designed to support compliance with three interconnected standards:
Together, these form the recommended risk management framework for laboratories seeking ISO 15189 accreditation.
- ISO 15189:2022 — Medical laboratories: Requirements for quality and competence. Clause 8.9 (Risk management) and Clause 8.4 (Nonconforming work) directly reference risk assessment obligations.
- ISO 22367:2020 — Medical laboratories: Application of risk management to medical laboratory processes. This standard provides the framework for applying FMEA in laboratory settings, including the RPN thresholds used here.
- ISO 31000:2018 — Risk management: Guidelines. Provides overarching principles and vocabulary for the risk management process.
Together, these form the recommended risk management framework for laboratories seeking ISO 15189 accreditation.
Can I add my own custom risks to the assessment?
Yes. Each phase tab includes an "Add a custom risk" input field at the top of the risk list. Type the name of your risk and press Enter or click + Add Risk.
Custom risks are labeled with a small (custom) indicator and can be removed individually using the ✕ button. They behave identically to built-in risks — they accept S, O, D scores and are included in the summary counts and CSV/text exports.
Tip: Use this feature to add lab-specific risks unique to your instrument portfolio, patient population, or local regulatory requirements.
Custom risks are labeled with a small (custom) indicator and can be removed individually using the ✕ button. They behave identically to built-in risks — they accept S, O, D scores and are included in the summary counts and CSV/text exports.
Tip: Use this feature to add lab-specific risks unique to your instrument portfolio, patient population, or local regulatory requirements.
How do I export results for my quality documentation?
The tool offers three export options at the bottom of the page:
Note: Only risks that have all three scores (S, O, and D) entered are included in exports. Partially scored risks are excluded.
- Download CSV Report — Exports all scored risks as a spreadsheet-compatible CSV file. Columns include Phase, Risk name, S, O, D, RPN, and Status. Ideal for attaching to your Quality Management System.
- Download Text Summary — Exports a formatted plain-text report with your lab's document reference number and today's date, structured by phase. Suitable for inclusion in CAPA records or audit evidence.
- Print — Opens your browser's print dialog. The tool interface strips navigation buttons and export controls from the printed output for a clean document.
Note: Only risks that have all three scores (S, O, and D) entered are included in exports. Partially scored risks are excluded.
How often should a laboratory perform risk assessments?
ISO 15189:2022 requires that risk management be a continuous and systematic process, not a one-time exercise. Best practice recommendations include:
- Annual review — Full risk assessment covering all phases, completed before each management review or accreditation surveillance audit.
- After significant incidents — Triggered by nonconformities, near-misses, adverse events, or patient safety events.
- After process changes — Whenever new instruments, reagents, staff, or procedures are introduced.
- After EQAS / PT failures — Examination-phase risks should be reassessed following any external quality assessment failure.
- CAPA closure verification — Risk scores should be re-evaluated after corrective actions are implemented to confirm risk reduction.
Is my data saved between sessions?
This tool runs entirely in your browser and does not transmit any data to external servers — your risk scores remain completely private and local to your device.
However, data is not automatically persisted between browser sessions. To save your work:
This design ensures full confidentiality of your laboratory's risk data in line with patient data protection requirements.
However, data is not automatically persisted between browser sessions. To save your work:
- Use Download CSV or Download Text Summary before closing the page.
- Print to PDF for a permanent archive copy.
- Complete your full scoring session in a single sitting for best results.
This design ensures full confidentiality of your laboratory's risk data in line with patient data protection requirements.
