Enter Quality Risk Inputs
Use 1 to 10 scoring for severity, occurrence, detection difficulty, and exposure. Higher values raise risk. Lower control and coverage also increase risk.
Example Data Table
| Process | Severity | Occurrence | Detection | Exposure | Control % | Coverage % | Customer Wt | Regulatory Wt | Defects | Batch | Normalized RSI | Band |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Incoming component inspection | 4 | 3 | 4 | 3 | 90 | 95 | 1 | 1 | 3 | 600 | 2.19% | Low |
| Final packaging seal check | 6 | 6 | 7 | 7 | 55 | 70 | 2 | 2 | 14 | 400 | 31.47% | Moderate |
| Sterile filling line deviation | 9 | 7 | 8 | 8 | 45 | 60 | 3 | 3 | 24 | 300 | 100.00% | Critical |
Formula Used
This calculator uses a weighted composite method suitable for internal quality control reviews. The normalized score is calibrated to a 5000-point reference value for easier comparisons.
Base Score = Severity × Occurrence × Detection
Impact Weight = (Customer Impact + Regulatory Impact) ÷ 2
Exposure Multiplier = 1 + ((Exposure Frequency - 1) ÷ 10)
Control Multiplier = 1 + ((100 - Control Effectiveness) ÷ 100)
Coverage Multiplier = 1 + ((100 - Inspection Coverage) ÷ 100)
Defect Rate = Defect Count ÷ Batch Size
Defect Multiplier = 1 + Defect Rate
Raw RSI = Base Score × Impact Weight × Exposure Multiplier × Control Multiplier × Coverage Multiplier × Defect Multiplier
Normalized RSI (%) = minimum of 100 and ((Raw RSI ÷ 5000) × 100)
How to Use This Calculator
- Enter severity, occurrence, detection difficulty, and exposure using your internal scoring rules.
- Enter control effectiveness and inspection coverage as percentages.
- Add customer and regulatory impact weights to reflect business consequences.
- Enter current defect count and inspected batch size.
- Select calculate to view the result directly above the form.
- Use the normalized score and risk band to guide containment, escalation, and corrective actions.
- Download the output as CSV or PDF for records, meetings, or audits.
Frequently Asked Questions
1. What does the normalized RSI show?
It converts the raw composite score into a 0 to 100 scale. That makes comparisons easier across lines, suppliers, products, and review periods.
2. Why include control effectiveness?
Strong controls reduce residual risk. Lower effectiveness raises the multiplier, showing that weak prevention or containment increases practical exposure.
3. Why does inspection coverage affect risk?
Lower coverage means more uncertainty. The calculator increases risk when fewer units, lots, or checkpoints are inspected.
4. Can I use different scoring scales internally?
Yes. Keep your internal rules consistent, then map them to the required input ranges so trend comparisons stay meaningful.
5. Is this the same as traditional RPN?
Not exactly. It starts with a similar base idea, then adds exposure, defect rate, coverage, and control strength for a broader quality view.
6. What should I do with a high score?
Review containment, verify measurement systems, escalate to the right owners, and prioritize corrective action before release or shipment.
7. Can I compare suppliers with this calculator?
Yes, if you use the same scoring standards, batch logic, and impact rules for each supplier or production source.
8. Does a low score mean no action is needed?
No. Low scores still need monitoring, documented review, and periodic verification so conditions do not worsen over time.