# Risk-to-evidence worksheet

Version 2.0 · Updated 2026-09-21 · Planning

Connect a credible failure to controls, evidence gaps and an assurance decision.

Adapt this template to your intended use, applicable requirements, and approved procedures.

## When to use it

A risk rating exists but the testing rationale is unclear.

## Information needed before starting

- Defined intended use and important requirements
- Credible failure scenarios and consequences
- Existing controls and available evidence

## Field instructions

- **Failure:** Describe a credible incorrect, missing or delayed result and trace it to the affected process, record or decision. Distinguish severity from how often it could occur.
- **Cause/context:** Describe the input, configuration or operating condition that makes the failure credible; distinguish a proposed cause from a confirmed one.
- **Consequence:** Trace the failure to the affected product, process, record or decision and explain why that consequence matters.
- **Existing control:** Describe the preventive or detective measure, responsible role and evidence that it works for the identified failure.
- **Control limitation:** Explain which failure paths the control does not prevent or detect, and what evidence or restriction addresses that gap.
- **Existing evidence:** Reference the exact evidence, version, date and assessed conditions. Explain the claim it supports, how it was reviewed and what remains unproven locally.
- **Gap:** State exactly which claim is unsupported by the existing evidence and what information is missing.
- **New evidence:** Specify the additional test, review or observation, its expected result and the evidence to retain.
- **Remaining uncertainty:** Describe what the combined evidence still cannot establish and how the uncertainty limits the decision.
- **Owner/action:** Assign the evidence or control action to an accountable role, with a due date and completion reference.

Does each assurance activity answer an identified question? Remove activities that add no useful evidence and address unexplained gaps.

## Completed fictional example

Fictional teaching example; replace its values with your own assessed facts and evidence.

| Field | Completed example |
| --- | --- |
| Failure | Quarantined material is accepted as released |
| Cause/context | Incorrect source-to-destination status mapping |
| Consequence | Material may be issued to production incorrectly |
| Existing control | ERP issue blocking based on accepted disposition |
| Control limitation | Blocking depends on correct mapping |
| Existing evidence | Reviewed standard ERP blocking behavior |
| Gap | Local mapping and interface recovery |
| New evidence | Mapping comparison, invalid-code challenge, delayed/duplicate message scenarios |
| Remaining uncertainty | New status codes introduced later |
| Owner/action | Interface owner controls mapping changes and monitors unknown codes |

## Blank template

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Failure | ____________________ |
| Cause/context | ____________________ |
| Consequence | ____________________ |
| Existing control | ____________________ |
| Control limitation | ____________________ |
| Existing evidence | ____________________ |
| Gap | ____________________ |
| New evidence | ____________________ |
| Remaining uncertainty | ____________________ |
| Owner/action | ____________________ |

## Related guidance

- [Assess functional risk](https://csvtocsa.com/learn/functional-risk-assessment)

- [Open the functional risk assessment template](https://csvtocsa.com/templates/functional-risk-assessment)

Canonical page: https://csvtocsa.com/worksheets/risk-to-evidence