Risk Assessments

Overview

Risk Assessments let your team evaluate how serious a risk is using a consistent, pre-defined scoring method. Instead of every assessor inventing their own scale, you build Risk Assessment Templates once — a matrix of Likelihood and Severity that maps to named risk levels — and then reuse them wherever a risk needs to be scored, such as inside Nonconformance (NC) and Corrective and Preventive Action (CAPA) workflow steps.

Each finalized assessment records the likelihood, severity, the computed risk level, and an optional justification, and tags it with a hazard category so risks can be grouped and reported. Assessments can capture both an initial risk (before action) and a residual risk (after action) for the same record.

Key concepts

Concept	What it means
Template	A reusable risk matrix: the likelihood levels, severity levels, risk levels, and how they combine into a score.
Likelihood	How likely the risk is to occur. Each level has a label (e.g. "Likely") and a numeric score.
Severity	How serious the impact would be. Each level has a label (e.g. "Severe") and a numeric score.
Risk level	The named, color-coded result a likelihood/severity combination maps to (e.g. Low, Medium, High).
Detectability (optional)	An extra factor for FMEA-style scoring. When enabled, the score becomes Likelihood × Severity × Detectability (the RPN).
Hazard category	The bucket a risk belongs to, used for grouping and reporting.
Assessment type	Whether the recorded result is the Initial risk or the Residual risk.

Default risk levels

New templates start with five color-coded risk levels you can rename, recolor, or remove:

Level	Typical use
Low	Minimal concern, no action usually required
Low Med	Minor concern, monitor
Medium	Moderate concern, review needed
Med Hi	Elevated concern, action recommended
High	Serious concern, action required

Hazard categories

Your account starts with seven standard hazard categories that you can rename or extend: Safety, Quality, Supply Chain, Regulatory, Financial, Operational, and Environmental.

How to create a risk assessment template

1. Open the Risk Assessment Templates page.
2. Select New Template in the top-right corner.
3. Enter a Template Name (required) and an optional Description describing when to use this template.
4. Review the Risk Levels. Each level has a color swatch and a label. Use Add Level to add one, the color box to change its color, or the X to remove it.
5. Set up your Likelihood rows on the left. Edit each label and its score, use Add to add a row, or the X to remove one.
6. Set up your Severity columns across the top. Edit each label and score, use the plus button to add a column, or the X above a column to remove it.
7. In the matrix grid, click any cell to assign it a risk level. Each click cycles to the next risk level in your list, so keep clicking until the cell shows the level you want.
8. Select Create Template to save.

tip

The matrix is pre-filled with sensible defaults the first time you open it: rows near the top are highest likelihood, columns to the right are highest severity. You only need to adjust the cells you disagree with.

Turning on detectability (FMEA)

If you score risks using the FMEA Risk Priority Number method:

1. In the template editor, scroll to Detectability (FMEA 3-factor RPN).
2. Switch it on.
3. Edit the detection levels and their scores. A score of 10 means hardest to detect; 1 means easiest to detect.

When enabled, the risk score is calculated as Likelihood × Severity × Detectability.

How to edit or delete a template

1. On the Risk Assessment Templates page, find the template in the list. You can use the search box to filter by name.
2. Open the actions menu at the end of the row.
3. Choose Edit to reopen the editor and select Save Changes, or Delete to remove it. Deletion asks you to confirm and cannot be undone.

note

The Edit and Delete options only appear if you have permission to update or delete templates. If you don't see them, contact your administrator.

How to perform an assessment

You score a risk wherever a risk assessment is requested — typically a step inside an NC or CAPA workflow:

1. Choose the hazard category that best describes the risk.
2. Pick the Likelihood level for how likely the risk is to occur.
3. Pick the Severity level for how serious the impact would be.
4. If the template uses detectability, pick the Detectability level too.
5. The matrix highlights the matching cell and shows the computed risk level (for example, Medium or High) and its score automatically.
6. Add a justification explaining your reasoning.
7. Save the step to record the assessment.

To capture a residual risk after corrective action, repeat the scoring on the same record — the system keeps the initial and residual results as separate entries so you can show the before-and-after comparison.

tip

Because each saved assessment stores the labels, scores, and colors used at the time, your reports stay accurate even if a template, risk level, or hazard category is later renamed or reconfigured.