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docs: add PROCESS.md — QMS compliance workflow for GitHub/Jira/Ketryx/Confluence [PYSDK-81]#569

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docs: add PROCESS.md — QMS compliance workflow for GitHub/Jira/Ketryx/Confluence [PYSDK-81]#569
helmut-hoffer-von-ankershoffen wants to merge 4 commits into
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@helmut-hoffer-von-ankershoffen

@helmut-hoffer-von-ankershoffen helmut-hoffer-von-ankershoffen commented Apr 24, 2026

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🛡️ Implements PYSDK-81 following CC-SOP-01 Change Control, part of our ISO 13485-certified QMS | Ketryx Project

Summary

  • Add PROCESS.md documenting how GitHub PRs, Jira (Anomaly + Change Request tickets), Ketryx releases, and the Confluence-based QMS (PR-SOP-01, CC-WI-01) relate and must be used together for regulatory compliance
  • Covers when to open an Anomaly ticket vs. a Change Request, the required bidirectional links between GitHub PRs and Jira tickets, and how Ketryx enforces traceability at release time
  • Includes a quick-reference table and explicit guidance for Claude Code on how to behave when creating PRs
  • Adds a References section linking to PR-SOP-01, CC-WI-01, and the Atlassian smart commits documentation

Why

Engineers and AI assistants working in this repo need a single place to understand the compliance obligations — particularly the bidirectional linking requirement between GitHub PRs and Jira tickets — without having to read through multiple Confluence SOPs.

Test plan

  • Review PROCESS.md for accuracy against PR-SOP-01 and CC-WI-01
  • Verify Jira board key (PYSDK) and ticket URLs are correct
  • Verify Confluence SOP links resolve correctly
  • Verify Atlassian smart commits reference link resolves correctly

🤖 Generated with Claude Code

Documents how GitHub PRs, Jira anomaly/change-request tickets,
Ketryx releases, and Confluence SOPs (PR-SOP-01, CC-WI-01) relate
and must be linked bidirectionally for regulatory compliance.

Also describes expected Claude Code behaviour when creating PRs.

Co-Authored-By: Claude Sonnet 4.6 <noreply@anthropic.com>
Copilot AI review requested due to automatic review settings April 24, 2026 13:38
@helmut-hoffer-von-ankershoffen helmut-hoffer-von-ankershoffen added the skip:test:long_running Skip long-running tests (≥5min) label Apr 24, 2026

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Pull request overview

Adds a new top-level engineering process document to explain how GitHub PRs, Jira (Anomaly + Change Request), Ketryx releases, and the Confluence QMS artifacts relate for compliance/traceability in this repo.

Changes:

  • Introduces PROCESS.md documenting bug-fix (Anomaly → PR), planned change (Change Request → PR), and release (Ketryx) workflows.
  • Defines bidirectional linking expectations between GitHub PRs and Jira tickets, plus a quick-reference matrix.
  • Adds explicit “Claude Code Workflow” guidance for creating/handling compliance-related PRs.

Comment thread PROCESS.md

4. Create GitHub PR
- PR description: link to the CR ticket
Example: "Implements PYSDK-CR-XX: https://aignx.atlassian.net/browse/PYSDK-XX"
Comment thread PROCESS.md
| **Ketryx** | Regulated release management — links Jira tickets to releases, collects approvals, enforces traceability |
| **Confluence (QMS)** | SOPs and work instructions that define the mandatory processes |

Ketryx sits on top of Jira: it reads Jira tickets of specific types (Anomaly, Change Request) and enforces that they are approved and linked before a release can be closed. A Ketryx release cannot be approved unless all linked items in Jira are in `Closed` status with the required approvals.
Comment thread PROCESS.md
- Title: follow conventional commits (fix: ...)
- PR body: include link to the Jira Anomaly ticket
Example: "Resolves PYSDK-78: https://aignx.atlassian.net/browse/PYSDK-78"
- Add label: skip:test:long_running
Comment thread PROCESS.md
Comment on lines +171 to +174
3. Remind you to get CR approval before merging if the CR is not yet Closed

> **Note**: Anomaly tickets are only required for bugs observed in Staging or Production.
> Changes made purely during development (before any deployment) do not need an Anomaly ticket per PR-SOP-01.
Copilot AI review requested due to automatic review settings April 24, 2026 13:59
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Pull request overview

Adds repository-facing process documentation to clarify how GitHub PRs, Jira tickets, Ketryx releases, and Confluence QMS SOPs fit together for compliance/traceability, and updates the Compass component metadata with operational links.

Changes:

  • Add PROCESS.md describing the compliance workflow (Anomaly vs Change Request, bidirectional linking, and release flow via Ketryx).
  • Update compass.yml to include links to the Jira board and the public status page.

Reviewed changes

Copilot reviewed 2 out of 2 changed files in this pull request and generated 1 comment.

File Description
compass.yml Adds Jira board + status page links to the Compass component definition.
PROCESS.md New engineering process guide documenting Jira↔GitHub traceability expectations and Ketryx release gating.
Comments suppressed due to low confidence (1)

PROCESS.md:175

  • PR description says PROCESS.md includes a "References" section (incl. PR-SOP-01, CC-WI-01, and Atlassian Smart Commits), but the document currently has no dedicated References section. Either add that section with the promised links or update the PR description to match the actual content.

> **Note**: Anomaly tickets are only required for bugs observed in Staging or Production.
> Changes made purely during development (before any deployment) do not need an Anomaly ticket per PR-SOP-01.

Comment thread PROCESS.md

4. Create GitHub PR
- PR description: link to the CR ticket
Example: "Implements PYSDK-CR-XX: https://aignx.atlassian.net/browse/PYSDK-XX"
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✅ All modified and coverable lines are covered by tests.
✅ All tests successful. No failed tests found.

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@helmut-hoffer-von-ankershoffen

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obsolete

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