ADR-0015: Document Effectivity, Periodic Review & Validity¶
- Status: accepted
- Date: 2026-06-17
- Deciders: Nicolas Burri
- Relates to: ADR-0003, ADR-0004, ADR-0014; GAP-05
- Refined by: ADR-0038 (periodic-review realization — derived due date, policy-gated confirmation)
Context¶
The life cycle (ADR-0003) has no time dimension. ISO 13485 §4.2.4 expects documents to be periodically reviewed and re-approved, and real QMS operation needs an effective date distinct from the release date (release now, effective later) and optional validity periods. None of this should add life-cycle states (ADR-0003 deliberately fixed them).
Decision¶
- Effective date as an attribute. A released version carries
effective_from(default = release time, settable to a future date); it is in force only from that date. The currently effective version of a document is derived: the released, non-revoked version with the latesteffective_fromnot after now. The prior version stays in force until the new version'seffective_from, then is superseded. (Refines REQ-LC-010.) No new states. - Periodic review. A review interval is configurable per document type, with an optional per-document override; the system computes a next-review-due date per effective document. A periodic review is recorded with reviewer(s), date, and outcome:
- confirmed unchanged → resets the next-review-due date without creating a new version (the review record is the audit evidence);
- revision initiated → starts a normal new DRAFT version (ADR-0003).
A periodic review may require an electronic signature with meaning
REVIEWED(ADR-0014), per the review policy. - Validity. A document may carry an optional
valid_until. - Overdue / expiry — flag & escalate only. When a periodic review is overdue or
valid_untilpasses, the document is flagged and surfaced (notification) for action but stays in force. LQMS never automatically revokes or removes effectivity from a controlled document — avoiding the danger of suddenly having no governing procedure. Revising or revoking remains a conscious, audited act.
Options Considered¶
- Effective date as a new life-cycle state (rejected): would break ADR-0003's fixed state set; effectivity is cleanly a derived attribute.
- Automatic hard expiry on overdue/validity end (rejected as default): operationally dangerous for controlled procedures; flag-and-escalate is standard QMS practice. Can be revisited per document type if a real hard-expiry use-case (e.g. certificates) appears.
Consequences¶
- Domain model gains
DOCUMENT_VERSION.effective_from, an optionalDOCUMENT.valid_until, and aPERIODIC_REVIEWentity (document, reviewer(s), date, outcome, next-due, optional signature). - "Currently effective version" and "review due/overdue" are computed, not stored states.
- Overdue/expiry surfacing depends on the notification capability (GAP-07).
- Periodic reviews and effectivity changes produce audit events (REQ-AUD-001).
Requirements¶
Introduces STR-020 and the REQ-EFF group (pending requirements baseline v1.1).