Solution
Quality and controlled procedures
Support quality and operations teams who must distinguish controlled procedure truth from informal practice and link NCRs to decisions and CAPA.
People involved
- Quality engineers
- Document control
- MRB participants
- Supervisors
Operational problem
Controlled documents, quality events, and floor practice drift apart. Informal practice can silently replace procedure.
Information sources
- Controlled procedures
- NCRs
- CAPA
- Decision records
- Unverified notes
Common failure modes
- Unverified practice treated as procedure
- CAPA actions not linked back to PM updates
- Superseded procedure still cited in training
Representative questions
- Which released procedure is current for this task?
- What CAPA actions changed the maintenance check?
- Is this shop-floor note verified?
Authority and revision requirements
- Release state
- Supersession
- Verification state
- Review ownership
Experiential knowledge
- Reviewed lessons learned tied to evidence
Evidence required
- Procedure headers
- NCR/CAPA links
- Review stamps on expert notes
Human approval boundaries
- Procedure release and MRB disposition remain human authorities
Expected qualitative value
Clearer separation of controlled truth vs practice; better auditability of why work changed.
Current availability
Demonstrated knowledge-class separation in public demo. Full QMS connectors planned.