Change Control
Quick facts
| Category | Controlled evaluation and approval of changes |
|---|---|
| Used by | Manufacturing, medical devices, pharmaceuticals, aerospace, automotive and other regulated industries |
| Also called | None widely standardized; often used interchangeably with change management |
| Related standards | ISO 9001, ISO 13485, AS9100, IATF 16949, FDA 21 CFR Part 820, GMP |
| Related processes | Document control, ECR/ECN, risk assessment, deviation management, CAPA |
| Semantic match | change control process, change management, ISO 9001 control of changes, change request approval workflow |
What is Change Control?
Change control is the structured process organizations use to manage changes that could affect product quality, process performance or regulatory compliance. It applies broadly, covering changes to manufacturing processes, equipment, suppliers, specifications, software and the quality management system itself.
A change control process typically starts with a documented change request describing what is changing and why. The request is then reviewed for potential impact, often including a risk assessment, before being authorized by designated personnel. Once approved, the change is implemented, communicated to affected teams, and any related documents, training or records are updated accordingly.
Change control is proportional by design: the level of review and approval required should scale with the significance of the change. A minor administrative correction may require lighter review than a change to a critical manufacturing process or a design specification.
Why is Change Control important?
Uncontrolled changes are a common source of quality problems, since a change made without proper evaluation can unexpectedly affect product performance, safety or compliance even when the intent behind the change was positive.
A disciplined change control process protects the integrity of the quality management system by ensuring that every change is evaluated for its potential impact before it is implemented, rather than discovered after a nonconformance or complaint occurs.
Change control also creates the documented evidence, including who authorized a change and why, that auditors and regulators expect to see when questions arise about why or when a process, product or document changed.
How does Change Control work?
A typical change control process includes:
- Change request. Document the proposed change, its rationale and scope.
- Impact assessment. Evaluate the potential effect on quality, compliance, cost and schedule, often including a risk assessment.
- Review and authorization. Route the change to the appropriate reviewers and approvers based on its significance.
- Implementation planning. Identify related documents, training and records that must be updated.
- Implementation. Execute the change and update all affected materials.
- Communication. Notify affected personnel and functions of the change.
- Verification. Confirm the change achieved its intended result without unintended effects.
- Closure. Document the completed change with evidence of review, authorization and verification.
Change Control vs. Document Control
| Comparison | Change Control | Document Control |
|---|---|---|
| Focus | Managing changes to processes, products or systems | Managing the lifecycle of a document |
| Trigger | A proposed change to how something is made or done | A document needs to be created, revised or retired |
| Relationship | Frequently results in one or more document updates | Often the mechanism used to formalize an approved change |
Real-world examples of Change Control
A medical device manufacturer proposes switching to a new adhesive supplier. Change control routes the proposal through a risk assessment and validation review before the new supplier is approved for production use.
An automotive supplier plans to change a machining parameter to improve cycle time. Change control requires a first-article inspection and customer notification, where applicable, before the new parameter is released to full production.
A pharmaceutical manufacturer updates a cleaning procedure following a corrective action. Change control ensures the revised procedure goes through document control, retraining and an effectiveness check before the prior version is retired.
Regulations and standards related to Change Control
ISO 9001 Clause 8.5.6, Control of Changes, requires organizations to review and control changes for production or service provision to the extent necessary to ensure continuing conformity with requirements, retaining documented information describing the review results, who authorized the change, and any necessary actions.
ISO 13485, AS9100 and IATF 16949 extend change control expectations with additional traceability and, in some cases, customer notification requirements for changes affecting form, fit, function or regulatory status. GMP regulations for pharmaceutical and food manufacturers similarly expect a documented change control process as a core element of the quality system.
Auditors commonly examine whether changes were assessed for risk before implementation, whether authorization occurred at an appropriate level, and whether related documents and training were updated consistently with the approved change.
Required by
How QT9 helps with Change Control
QT9 QMS change control capabilities
- Automate change request routing, review and approval workflows.
- Initiate risk assessments directly from within change control records.
- Maintain a complete audit trail and change history for every record.
- Bulk approve and publish documents linked to a change control record.
- Configure email alerts for due dates and pending approvals.
- Build custom types and categories for change control reporting and KPIs.
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Common mistakes with Change Control
Common mistakes include implementing a change informally before formal approval is complete, and applying the same level of review to every change regardless of its actual risk or significance.
Other problems include failing to update all documents, training records or downstream specifications affected by a change, and not verifying after implementation that the change achieved its intended result without introducing new issues.
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