Icologiq Knowledge · Method
Impact Assessment
A structured evaluation of the potential consequences of a proposed change before approval and implementation.
Also known as:
change impact assessment, impact analysis, change impact analysis
At a glance
Type
Method
Topic
Change/HSE
Applies to
Cross-industry
Current version
Status
Last reviewed
September 29, 2026
Definition
An impact assessment evaluates the potential consequences of a proposed change before it is approved and implemented. Depending on the context, the assessment can consider product or process quality, health and safety, environmental risk, regulatory commitments, validation, documents, training, suppliers, systems, data and other affected processes. The required depth should be proportionate to risk and complexity.
Why it matters
Changes often fail because teams evaluate the requested modification but not the processes and evidence around it. A structured impact assessment helps Quality and QHSE teams identify affected documents, training, risk controls, validation, compliance obligations and follow-up before implementation. That makes change approval more defensible and reduces unintended consequences after release.
Define what is changing, why, when and which current state will be replaced or affected.
Describe the change and intended outcome
1
Map direct and indirect impacts across operations, quality, safety, compliance, IT, suppliers and customers as relevant.
Identify affected processes and stakeholders
2
Evaluate how the change could alter hazards, controls, validated states, responsibilities, data or regulatory obligations.
Assess risks and dependencies
3
Determine which documents, training, tests, approvals, migrations, communications or controls need to change.
Identify dependent actions
4
Summarize significant impacts, uncertainties and required conditions so approvers can make an informed decision.
Support the approval decision
5
Check whether predicted impacts and planned controls were addressed and capture unexpected effects for follow-up.
Verify after implementation
6
Method explained
Assessing the consequences of a proposed change
Impact Assessment helps decision-makers identify which processes, people, systems and obligations could be affected before a change is approved. The method is strongest when it follows interfaces beyond the obvious area of change.
A formal process for proposing, assessing, approving, implementing and documenting changes that can affect quality, compliance, products or validated processes.
Change Control
Process
· Change
A structured process for evaluating and controlling safety, operational and compliance risks before significant technical, organizational or process changes are implemented.
Management of Change
Process
· Change/HSE
A structured assessment used to identify hazards or uncertainties, estimate their risk and determine whether controls or further action are required.
Risk Assessment
Process
· Risk
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