See the risk.Track the response.Review the risk.
Record failure modes, score severity, occurrence and detection, and follow each mitigation to its target.
Risk and mitigation, seen together.
Follow one risk
What can go wrong, and what it does
Describe the failure mode and its effect on patient, product or process.
How the risk register works: failure mode, scoring, mitigation and review
1. What can go wrong, and what it does
Describe the failure mode and its effect on patient, product or process.
Add the cause and the controls already in place.
Search by risk number, title or failure mode.
- Approach
- Structured for FMEA and ICH Q9-style risk management.
Your team identifies the risks; V5 does not generate them.
RSK-0031 · new
Risk register
- Failure mode
- Wrong label loaded
- Effect
- Mislabelled product
- Cause
- Similar artwork
- Current controls
- Visual check
- Type
- Process
Failure mode and effect are required.
2. Scored 1–10 Three Ways
Score severity, occurrence and detection from 1 to 10.
RPN is calculated automatically.
High-RPN filters bring the biggest risks to the top.
- Bands
- Low below 100, medium 100–199, high 200 and above.
Scoring scales and acceptance limits come from your procedure.
RSK-0031 · scoring
FMEA
- Severity
- 8
- Occurrence
- 4
- Detection
- 7
- RPN
- 224 · High
- Bands
- <100 · 100–199 · ≥200
Calculated, not typed.
3. A Plan with a Target
Write the action that will reduce severity, occurrence or detection.
Set the target RPN after mitigation.
Move the risk through mitigating and verifying.
- Changes
- Mitigations that alter equipment or documents run through change control.
Whether a mitigation is adequate is for your team to judge.
RSK-0031 · mitigation
Plan
- Action
- Scan label at line start
- Target RPN
- 56
- Status
- Mitigating
- Linked
- Change CC-0061
- Owner
- Packaging lead
Which of S, O or D does it reduce?
4. Accepted, closed, or looked at again
Verify the mitigation and re-score.
Accept or close the risk.
Set the next review date.
- Review
- Open high risks feed management review.
Who can accept a residual risk is set by your administrators.
RSK-0031 · review
Verification
- Re-scored RPN
- 56
- Status
- Accepted
- Next review
- Apr 2027
- History
- Every move kept
- Open risks
- Active-only filter
A date keeps it alive.
Where risk fits
Risks feed change control, CAPA and management review.
- Change ControlImpact on validation, filings, training and documents before approval.See Change Control
- This pageRisk register & FMEASeverity × occurrence × detection with a target after mitigation.
- Audits & CAPAFindings graded by a person, with follow-ups to close.See Audits & CAPA
- Management ReviewPrepare the quality review pack from live records.See Management Review
AI and Risk register & FMEA
A risk description is not a risk acceptance
A risk description is not a risk acceptance
Use AI help to explore the evidence and responsible owners behind a risk entry. The scoring method and acceptance criteria belong to your process.
Everything in this feature
What the risk register uses, and which plan each item needs. Compare plans
Risk register / FMEA
EnterpriseFailure mode, effect, cause, controls.
Calculated RPN
EnterpriseS × O × D with bands.
Mitigation and target RPN
EnterpriseTracked to verification.
Next review date
EnterpriseFor accepted risks.
V5 does the arithmetic and keeps the history. People decide what is acceptable.
Explore the sample records.
Open a sample report to review its contents, supporting references and how the record is built.
UltimateSample register
Risk register / FMEA (CSV)
Quality system
Quality Management Buyer Guide
For quality, regulatory and operations teams choosing quality management software. Use it with or without V5.
- Why quality systems stall
- Issue-to-closure evidence map
- Documents, revisions and training
- Deviations, out-of-spec results and CAPA effectiveness
Plus Audits, complaints, supplier quality and traceability; Requirement vs configured workflow vs lab system; Risk-based evaluation, decision checklists, RFP and scoring.
Get the quality management guideWe ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy.
UltimateFree buyer guide
Quality Management Buyer Guide
Straight answers.
What buyers ask us first about Quality & Laboratory.
Does V5 release product automatically?
No. V5 gathers results and records for review, but a person in quality decides and signs the release.
What does the lab side cover?
Lab and QC covers sampling, instruments, methods, results and out-of-spec handling, with LIMS, lab notebook, stability and SPC on top. These are Enterprise features; see Compare details on the pricing page.
Can we use V5 in a validated environment?
For validation-controlled operations, V5's route is Enterprise private cloud with controlled upgrades and IQ/OQ support. Your team still validates V5 for its intended use.
More of the product
Start with one area. Add the rest when you are ready.
Warehouse & TraceabilityExplore 
Production & PlanningExplore 
This feature's areaQuality & LaboratoryExplore 
Documents & TrainingExplore 
Equipment & PerformanceExplore 
Orders & IntegrationsExplore
Try it with one process you worry about.
Start a free trial or talk it through with us. No card needed.