Configuration

CODEOWNERS

The CODEOWNERS file controls who must approve changes to controlled documents. Map each QMS directory to the appropriate reviewers:

qms-policy/    @my-org/quality-leadership
qms-sops/      @my-org/quality-team
product-*/     @my-org/engineering-lead @my-org/quality-team

GitHub will automatically request reviews from these teams when a PR touches their paths.

QMS Config

docs/qms-config.yml controls automation behavior:

• trainees: GitHub usernames who receive training assignments when SOPs change
• document_prefix: Prefix for document numbering
• retention_years: Default retention period for quality records
• regulatory_modules: Which regulatory modules are active

Branch Protection

The setup script configures:

• Require PR reviews before merging
• Dismiss stale reviews on new commits
• Require status checks to pass (document control, traceability)
• Disable force-push (protect audit trail)
• Enforce for administrators

Labels

The setup script creates labels for QMS workflow:

Label	Purpose
capa / capa-open	CAPA tracking; open CAPAs block releases
ncr / ncr-open	Nonconformance tracking; open NCRs block releases
change-request	Change control
design-input / design-output	Design control traceability
training	Training assignments
release-blocker	Blocks release gate
verification / validation	V&V tracking