Change Management

Overview

Change Management provides engineering change control compliant with ISO 10007:2017 and ISO 9001:2015 §8.5.6. It manages the change request (ECR) → engineering change order (ECO) → change notice (ECN) flow together with CLASS I/II/III classification and CCB (Change Control Board) approval; every step is written to the audit trail.

Key Concepts

• ECR (Engineering Change Request) — the formal request for a change; once the impact analysis is complete it is promoted to an ECO.
• ECO (Engineering Change Order) — the approved change order to be implemented; it carries verification records and CCB approval.
• ECN (Engineering Change Notice) — notification of the change taking effect, sent to the relevant parties; it requires acknowledgement.
• Change class — determined automatically from the impact analysis:
  • CLASS I — Major: there is a fit/form/function impact; CCB approval and customer notification are required.
  • CLASS II — Minor: form/function are unaffected; engineering approval is sufficient.
  • CLASS III — Administrative: a document/description correction.
• Impact analysis — the mandatory assessment made up of safety criticality, fit/form/function impact, regulatory impact, customer notification requirement, tooling/fixture change and test/verification requirement (ISO 9001:2015 §8.5.6).

Typical Workflow

1. Open Change Management from the left-hand menu and create the change request with New ECR (title, description, justification, requester details).
2. Fill in the impact analysis fields — ticking fit_form_function_affected triggers CLASS I classification.
3. Specify the affected item (part number, current/target revision).
4. Once the ECR is approved, promote it to an ECO with promote-to-eco.
5. Track the CCB approval status on the ECO, and manage the cascade requirements and the verification plan.
6. When verification is complete, create the ECN that brings the ECO into effect and request acknowledgement from the relevant parties.
7. Monitor the class distribution and recent ECO activity from the dashboard.

Feature Reference

• End-to-end ECR → ECO → ECN state machine with transition control
• Automatic CLASS I/II/III classification based on the impact analysis
• CCB approval flow and cascade requirement tracking
• Verification plan records and verification status updates
• Audit trail: ISO 10007 §6.4 compliant — who, when, from which state to which state
• Dashboard: ECR/ECO summary, class distribution, recent activity
• ECN acknowledgement tracking

Constraints / Known Limits

• Electronic signatures and 21 CFR Part 11 compliance must be separately certified at production level.
• The audit trail is held in the demo data layer; production requires an immutable storage layer.
• Automatic cascade triggering with other modules (BOM Intelligence, DPP Configurator) is being continuously expanded.