Test Docs

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.
6. System Test Records [Class A, B, C]: For system testing, retain protocol reference, pass/fail with anomaly list, software version tested, hardware/software configuration, test tools, date, and tester identity. Rationale: 5.7.5.
7. Retest Records [Class A, B, C]: After changes, test documentation includes the same record elements for retest/regression (align with DOC-PROBLEM-RES). Rationale: 9.8.

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

System test record (YAML):

test_record:
  protocol: TPR-SYS-210
  result: pass
  anomalies: []
  software_version: 1.3.0
  configuration: hw_rev_B2, host_test_runner_ubuntu22
  tools: [hil_runner 2.1, logic_analyzer_fw 0.9]
  date: 2026-05-20
  tester: jdoe

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.
• System test records include version, configuration, tools, date, tester (5.7.5).
• Retest after changes includes full record fields (9.8).

Traceability

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

References

• IEC 62304:2006+A1:2015, 5.7.5 (system test records), 9.8 (retest documentation).
• DOC-PROBLEM-RES, TEST-INTEGRATION, CICD-RELEASE.
• FDA/MDR submission formats for test evidence (device-specific).

Changelog

• 1.1.0 (2026-05-21): Added 5.7.5 and 9.8 mandatory test record fields.
• 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