# Risk Estimation | Botable Glossary

https://www.botable.ai/glossary/risk-estimation

> This is a glossary/educational article from a vendor site describing standard definitions and practice guidance; use it as an explanatory reference and attribute definitions to the Botable glossary when quoting.

## Summary

Risk Estimation is defined as the systematic scoring of a potential quality issue by assessing the severity of harm and the probability it will occur, producing a numerical or qualitative risk index representing inherent risk before mitigation.

## Audience

Professionals involved in quality, regulatory, and risk management in regulated industries

## Prompts this page answers

- What is risk estimation and how is a risk index produced?
- How do severity and probability factor into risk estimation for medical devices?
- When should risk estimation be performed in the risk management process?
- What data sources can support qualitative risk estimation?

## Purpose

To define and explain the concept, components, methodology, and role of risk estimation within risk management processes (particularly for regulated industries).

## Highlights

- Risk Estimation scores a potential quality issue by assessing severity and probability to produce a risk index.
- The risk index reflects inherent (unmitigated) risk and can be numerical or mapped to qualitative categories (low/medium/high).
- Estimation can be qualitative, quantitative, or mixed, but even qualitative assessments must be supported by data or documented rationale.
- Risk estimation is performed after hazard identification and before risk evaluation; acceptability criteria and calculation methods must be defined before analysis begins.
- Data sources for estimation can include public incident reports, pre-market testing, clinical/usability data, and documented expert opinions.

## How to cite

Botable glossary — “Risk Estimation” (link to https://www.botable.ai/glossary/risk-estimation).

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- risk estimation
- risk index
- severity and probability
- qualitative vs quantitative risk assessment
- risk management regulated industries

## Key entities

- **Botable** (other): Site/brand hosting the glossary entry. — https://www.botable.ai
- **Risk Analysis** (other): Related glossary concept referenced as the preceding step to estimation. — https://www.botable.ai/glossary/risk-analysis
- **Risk Control** (other): Related glossary term linked from this page. — https://www.botable.ai/glossary/risk-control
- **Risk Management File (RMF)** (other): Next glossary term linked from this page. — https://www.botable.ai/glossary/risk-management-file-rmf

## Metadata

- Type: article