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.

Submit an impact assessment

1. On the left sidebar, select Change Control.
2. Select the change request you need to assess to open the change detail page.
3. In the Change Assessment section, select Create Assessment.
4. From the Assessment Type dropdown, select one: Technical, Quality, Regulatory, Safety, or Financial (required).
5. In the Findings field, describe the findings from the impact assessment (required).
6. In the Recommendations field, enter recommendations based on the assessment findings (optional).
7. In the Risk Score (1-10) field, enter a numeric risk rating from 1 (minimal risk) to 10 (critical risk) (optional).
8. In the Mitigation Actions field, describe actions to mitigate the identified risks (optional).
9. Select Submit Assessment.

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

Assessment types

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.

Risk score guidelines

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 confirms 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.

Practical example: Assessing a supplier change

A medical device manufacturer needs to qualify a new supplier for surgical-grade stainless steel tubing after the current supplier announced end-of-life for the specific alloy specification used in their Class III implantable device.

The quality assessor opens change request CC-039 (“Qualify Alternate Supplier for 316LVM Stainless Steel Tubing”) and submits three assessments.

Technical assessment

• Assessment Type: Technical
• Findings: “New supplier (MetalPure Inc.) provides 316LVM tubing per ASTM F138. Sample lot analysis (Lot MP-2026-003) shows chemical composition within specification. Dimensional tolerances are tighter than current supplier (0.002 mm vs. 0.005 mm). Surface finish Ra values averaged 0.18 um vs. current 0.22 um. Incoming inspection procedures IQC-STL-001 require no modification.”
• Risk Score: 5
• Recommendations: “Proceed with qualification. Run 3 production lots using new material before full transition. Verify laser welding parameters remain within validated ranges with the tighter dimensional tolerances.”
• Mitigation Actions: “1. Perform welding validation study (Protocol VP-2026-011) with new material. 2. Complete biocompatibility testing per ISO 10993-5 on finished devices from first production lot. 3. Retain 6-month parallel supply agreement with current supplier as backup.”

Quality assessment

• Assessment Type: Quality
• Findings: “Supplier audit (SA-2026-007) completed on 2026-02-15. MetalPure Inc. holds ISO 13485:2016 certification (cert #QMS-48291, valid through 2028-01). Quality agreement draft reviewed — meets all requirements per SOP-SQM-003. No FDA warning letters or recalls in past 5 years. Material certificates of analysis reviewed for 5 lots — all within specification.”
• Risk Score: 3
• Recommendations: “Approve supplier qualification. Add MetalPure Inc. to Approved Supplier List with initial classification as ‘Conditional’ for first 12 months, then upgrade to ‘Preferred’ pending satisfactory performance.”
• Mitigation Actions: “1. Establish incoming inspection sampling plan per ANSI/ASQ Z1.4, Level II, AQL 0.65%. 2. Schedule follow-up audit at 6 months. 3. Monitor supplier CAPA responsiveness during conditional period.”

Regulatory assessment

• Assessment Type: Regulatory (submitted as a Technical type with regulatory focus in findings)
• Findings: “Material change constitutes a change to a component of a Class III device. Per FDA guidance on PMA supplements, this requires a 180-day PMA supplement (not a 30-day supplement or annual report) because the raw material supplier is a critical component supplier. EU MDR Article 120 transition timeline must also be considered for the Technical File update. Notified Body (TUV SUD) should be notified of the planned change.”
• Risk Score: 7
• Recommendations: “Begin PMA supplement preparation immediately. Engage regulatory affairs team to prepare submission package including biocompatibility data, supplier qualification report, and process validation data.”
• Mitigation Actions: “1. Submit PMA supplement to FDA before transitioning production. 2. Update Technical File and notify TUV SUD. 3. Do not ship devices made with new material until PMA supplement is approved.”

The combined risk scores (5, 3, and 7) inform the approvers that while technical and quality risks are manageable, the regulatory pathway requires careful planning before the change can be implemented.