1. Clear, justified change requests
Capture the change type, scope, rationale, intended result, affected areas, and supporting material at the outset, reducing repeated review cycles and unresolved questions.
Change Control | Core capabilities available
Core capabilities availableAssess every change before it reaches the product, process, or controlled document.
QSigma360 turns change from scattered messages and undocumented decisions into a controlled path. Each request starts with a clear rationale, moves through impact assessment, risk review, and authorization, and ends with verified implementation and a complete decision history. Every participant can see what will change, why it matters, who approved it, and what must be completed before the change takes effect.
The problem and the value
A change may look small—a new supplier, an adjusted production setting, a revised specification, or an updated procedure. Its effects can spread across product risk, documentation, training, inventory, customers, and compliance obligations. When those decisions live in email threads or disconnected spreadsheets, teams struggle to confirm whether the right people reviewed the change or whether implementation matched the approved plan.
QSigma360 brings the request, assessment, actions, evidence, and related records into one traceable workspace. Teams gain a more disciplined decision process, fewer unplanned consequences, and clearer evidence of why the change was accepted and how its impact was controlled.
Six core capabilities
2. Impact and risk assessment
Evaluate potential effects on product, process, quality, food safety, suppliers, controlled documents, and competence. Record identified risks and required controls before implementation is authorized.
3. Cross-functional review
Route each request to the appropriate functions—such as quality, operations, engineering, or procurement—with visible review status, comments, decisions, and ownership.
4. Implementation and rollback planning
Translate an approved decision into accountable actions, due dates, and evidence requirements. Where appropriate, define stop conditions or a rollback approach if the outcome is unacceptable.
5. Connected record updates
Link the change to documents, training, risk assessments, CAPAs, suppliers, and relevant audit records so that no material dependency is left outside the implementation plan.
6. Post-implementation verification
Completion is more than checking off tasks. Review evidence, compare results with the intended outcome, and document deviations or follow-up actions before final closure.
How it works
- 1Submit: Define the rationale, scope, owner, target date, and supporting information.
- 2Triage: Check completeness and identify the functions required for assessment.
- 3Assess: Review risks, dependencies, and affected operational or compliance requirements.
- 4Review and approve: Capture comments, decisions, and authorization under configured roles.
- 5Implement: Complete actions, document updates, and training while collecting required evidence.
- 6Verify and close: Confirm the intended result, address unacceptable effects, and close or initiate follow-up.
Integration and governance
Change control is stronger when it operates inside the same quality ecosystem as the records it affects. A request can connect to the CAPA that identified the need, the controlled document requiring a new version, the training that must be completed before the effective date, or the risk record requiring an additional control. Role-based permissions, configured approval paths, timestamps, and activity history preserve a clear sequence from request through authorization and verification. Technical judgment remains with authorized people; QSigma360 structures and records the decision rather than replacing professional review.
Illustrative view — no customer data
A simplified view of the workflow
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The problem and the value
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Six core capabilities
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How it works
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Integration and governance
Frequently asked questions
What types of change can the module manage?
It can support changes involving processes, equipment, specifications, materials, suppliers, methods, documents, and systems. Assessment fields and required reviewers can be adapted to the change category and organizational policy.
Can a change be implemented before approval is complete?
The configured workflow determines when a record may advance. Its purpose is to prevent routine implementation before required reviews are complete, while allowing emergency handling to be documented separately under approved policy and authority.
How does change control connect with documents and training?
Document revisions and required training can be included in the implementation plan and linked to the change record. This keeps readiness visible instead of relying on external emails or untracked lists.
What if the change does not achieve the intended outcome?
The verification result is recorded. Teams can add corrective actions, extend monitoring, apply a rollback plan, or escalate the issue to CAPA according to its impact and risk.
Make every change a considered, defensible decision.
See how QSigma360 connects assessment, authorization, implementation, and verification in one traceable record.