Test Documentation

Purpose

Define structure and content for test plans, protocols, and reports that support regulatory submissions and internal verification.

When to Apply

• •Planning and executing verification/validation across unit, integration, system, and HIL.
• •Preparing evidence for submissions or audits.

Requirements (testable)

1. •Test Plan: Objectives, scope, environment, roles, entry/exit criteria, and traceability to requirements/risks. Rationale: structured verification.
2. •Protocols: Step-by-step procedures, inputs, expected results, and acceptance criteria; include negative cases. Rationale: repeatability.
3. •Reports: Actual results, deviations, defects, and conclusion vs acceptance criteria. Rationale: evidence of execution.
4. •Traceability: Each test case links to requirements/hazards; matrices maintained. Rationale: completeness.
5. •Configuration Control: Environments, tools, and versions recorded; reproducible setups. Rationale: consistency.

Recommended Practices

• •Use IDs for test plans (TPL-###), cases (TC-###), protocols (TPR-###), and reports (TRP-###).
• •Include data sets and seeds where applicable.
• •For automation, capture logs and artifacts (coverage, waveforms, power traces).

Patterns

Test plan snippet (Markdown):

TPL-210: Pump Safety Verification Plan
Scope: Class C control loop, door-open safety
Entry: unit/int tests pass; firmware v1.3.0
Exit: all TC pass; defects triaged; coverage targets met
Trace: REQ-62304-102, HZ-07, RISK-CTRL-19

Protocol entry (table):

Step | Action | Expected
1 | Open door sensor | Motor stops within 50 ms; alarm active

Report excerpt:

TRP-210 Result: PASS
Deviations: None
Defects: DEF-88 (UI lag) - not safety relevant

Anti-Patterns (risks)

• •Missing traceability -> risk: unverifiable coverage.
• •Only positive tests documented -> risk: gaps in error handling evidence.
• •Uncontrolled environments -> risk: irreproducible results.
• •Reports without deviations/defects -> risk: incomplete transparency.

Verification Checklist

• • Test plan exists with scope, criteria, and traceability.
• • Protocols include steps, inputs, expected results (positive/negative).
• • Reports capture actual results, deviations, defects, and conclusions.
• • Environments/tools/configurations recorded.
• • Traceability matrix maintained requirements↔tests.

Traceability

• •IDs (TPL-###, TC-###, TPR-###, TRP-###) linked to REQ-### and HZ-###; stored with release artifacts.

References

• •IEC 62304 verification documentation expectations.
• •FDA/MDR submission formats for test evidence (device-specific).

Changelog

• •1.0.0 (2026-01-04): Initial test documentation skill with plans, protocols, and reports.

Audit History

• •2026-01-04: Audit performed. Verified:
  • •IEC 62304 verification documentation expectations accurate
  • •FDA/MDR submission format references appropriate