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.

View term

A formal process for proposing, assessing, approving, implementing and documenting changes that can affect quality, compliance, products or validated processes.

Change Control

Process

· Change

View term

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

View term

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

View term

The structured management of legal, regulatory, certification and internal obligations, including responsibilities, evidence, actions and periodic checks.

Compliance Management

Process

· Compliance

View term

The process of ensuring that approved documents are current, traceable, accessible to the right people and protected against uncontrolled change or use.