CSA method

Validation Rationale — Connect the decision to evidence

A useful explanation lets another qualified person follow the decision without relying on confidence or presentation style. Start with the actual process and show the connection to evidence.

Author
Sandip Thorat
Published
12 September 2026
Last reviewed
12 September 2026
Version
1.0
Content type
Practitioner guidance
Primary references
See related regulations, guidance, and approved procedures

A useful explanation lets another qualified person follow the decision without relying on confidence or presentation style. Start with the actual process and show the connection to evidence.

Five connected questions

What is the system used for? What failure matters? What controls address it? What evidence supports the controls? What conditions and unresolved issues qualify the conclusion?

Completed example — fictional

Use: MES receives operator eligibility before OP-21.

Failure: Expired training is treated as current.

Control: Defined expiry logic, identity mapping, and task-start blocking.

Evidence: Reviewed configuration, independent expiry expectations, boundary tests, and traced interface events.

Decision and limit: Approved for the defined production area; practical competency is controlled elsewhere. A new role mapping requires assessment.

What a weak narrative sounds like

“We validated the system according to our procedure and all tests passed.” This may be true, but it does not tell a reviewer which use was assessed or whether the relevant failure was challenged.

Reusable worksheet

Capture each claim with its evidence location, owner, limitations, and current status. Add the governing record reference so the map remains an index, not an uncontrolled duplicate approval record.

Exercise: A release summary says an open defect is “minor.” What should the narrative add?

Answer: Explain the affected behavior, consequence, control, scope of acceptance, owner, and required follow-up. The label alone does not show why use is acceptable.

Questions and discussion

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