Understand
A proposed before-and-after workflow
An issue is recorded locally, emailed for review, and retyped into separate corrective-action and reporting trackers.
A linked record identifies product, batch, requirement, disposition, owner, approvals, and evidence; overdue actions and integration failures route to named reviewers.
The future state remains a design until it is tested with the people, data, systems, and exceptions in scope.
Deliver
Scope and deliverables
The exact package follows discovery and agreed responsibilities. A typical engagement can include:
01Quality-record and state model
Confirm this during discovery and record the owner, evidence, acceptance decision, and fallback.
02Inspection and non-conformance workflow
Confirm this during discovery and record the owner, evidence, acceptance decision, and fallback.
03Role and approval matrix
Confirm this during discovery and record the owner, evidence, acceptance decision, and fallback.
04Traceability and retention design
Confirm this during discovery and record the owner, evidence, acceptance decision, and fallback.
05Test evidence, procedures, and handover
Confirm this during discovery and record the owner, evidence, acceptance decision, and fallback.
Deliver
Data and decisions needed
Access is limited to what the agreed work needs. Client owners approve source authority, operational rules, and acceptance criteria.
| Reference | Input or decision to establish |
|---|---|
| 01 | Approved specifications and inspection plans |
| 02 | Product, batch, supplier, and equipment identifiers |
| 03 | Disposition and corrective-action rules |
| 04 | Retention, access, and validation requirements |
Deliver
Delivery sequence
A bounded sequence protects continuity and makes learning visible before wider rollout.
- 01Confirm quality-system boundaryDefine evidence and the exception path
- 02Map records, roles, and signaturesDefine evidence and the exception path
- 03Design states and prohibited transitionsDefine evidence and the exception path
- 04Configure and test representative scenariosDefine evidence and the exception path
- 05Validate where required under client proceduresDefine evidence and the exception path
- 06Train authorized roles and release under change controlConfirm ownership and handover
Govern
How it fits existing systems
Existing systems are mapped by business responsibility, supported interface, data authority, update timing, and failure behavior. The design may integrate, configure, retain, or replace a component; no universal compatibility is assumed.
Govern
When a different approach may be better
Where an existing quality management system already supports the process, configuration and integration may be safer than introducing another record store.