Impact Assessment

Impact assessment is a critical step in the change control workflow where authorized assessors evaluate the potential effects of a proposed change. The assessment documents findings, assigns a risk score, and recommends mitigation actions before the change proceeds to approval.

Performing an Impact Assessment

To submit an impact assessment for a change request:

1. Navigate to Change Control and open the change request you need to assess
2. Click the Assess action to open the assessment form
3. Complete the assessment fields
4. Click Submit Assessment

The page header displays the change number and title for reference while you work.

Assessment Form Fields

Required Fields

Field	Description
Assessment Type	The category of assessment being performed. Select one from the dropdown.
Findings	A detailed description of the findings from the impact assessment. This is the core of the assessment.

Assessment Types

The following assessment types are available:

Type	When to Use
Technical	Evaluate technical feasibility, system compatibility, and engineering impact
Quality	Assess impact on product quality, testing requirements, and quality systems
Regulatory	Evaluate regulatory compliance implications, required submissions, or notifications
Safety	Assess impact on personnel safety, environmental safety, or product safety
Financial	Evaluate cost implications, budget impact, and resource requirements

Tip

For complex changes, multiple assessments of different types may be submitted. For example, a process change might require both a Technical assessment and a Regulatory assessment.

Optional Fields

Field	Description
Recommendations	Recommendations based on the assessment findings. Include any conditions or prerequisites for proceeding.
Risk Score (1-10)	A numeric risk rating from 1 (minimal risk) to 10 (critical risk). Must be a whole number.
Mitigation Actions	A description of actions to mitigate the risks identified in the findings.

Risk Score Guidelines

Use the following scale when assigning a risk score:

Score Range	Risk Level	Description
1 - 3	Low	Minimal impact; standard controls are sufficient
4 - 6	Medium	Moderate impact; additional controls or monitoring may be needed
7 - 8	High	Significant impact; requires mitigation actions before proceeding
9 - 10	Critical	Severe impact; may require executive review or alternative approach

Caution

The risk score must be a number between 1 and 10. Values outside this range will be rejected by the system.

After Submitting an Assessment

After a successful submission:

1. A success message is displayed confirming the assessment was recorded
2. You are automatically redirected to the change detail page
3. The assessment is attached to the change request record
4. Approvers can review the assessment findings when making their approval decision

Best Practices

• Document specific findings rather than general statements
• Include references to relevant standards, regulations, or SOPs in your findings
• When risk scores are high (7+), always include mitigation actions
• Provide clear, actionable recommendations that approvers can evaluate
• Consider cross-functional impacts — a change to one area may affect others