Supplier Risk Classification

Supplier classification determines the risk category of a supplier based on a structured assessment of five dimensions. The resulting risk category drives qualification requirements, monitoring frequency, and oversight level.

Risk Categories

Category	Score Range	Description
Critical	12 — 15	Direct impact on product quality and patient safety
Major	8 — 11	Significant impact on quality systems or regulatory compliance
Minor	4 — 7	Limited impact on quality, indirect services
Non-Critical	Below 4	No impact on product quality

Assessment Dimensions

The classification form evaluates five risk dimensions. Each dimension is rated as High (3 points), Medium (2 points), or Low (1 point).

Dimension	Assessment Question
Impact on Product Quality	How directly does this supplier impact the quality of the final product?
Impact on Patient Safety	Could a failure from this supplier impact patient safety?
Regulatory Impact	What is the regulatory impact if this supplier fails to meet requirements?
Process Criticality	How critical is this supplier to your manufacturing/business processes?
Data Integrity Risk	Does this supplier handle data that impacts GxP compliance or data integrity?

The total score is calculated by summing all five dimension scores (minimum 5, maximum 15), and the risk category is derived from the score ranges above.

Performing a Classification

Step-by-step procedure

1. Navigate to the supplier profile page
2. Click the Classify button in the header, or go to the Classification tab and click Classify Supplier
3. For each of the five dimensions, select High, Medium, or Low by clicking the corresponding option
4. Review the Classification Preview card, which shows the estimated risk category and total score in real time
5. Enter a Justification explaining the reasoning for this classification (required)
6. Click Submit Classification

Note

The preview score shown on the form is a client-side estimate. The server calculates the final score using configurable weights, which an administrator can adjust. The final category may differ from the preview if custom weights have been configured.

Default dimension values

All dimensions default to Medium when the form opens. Adjust each dimension based on your assessment of the specific supplier.

Classification History

Each time a supplier is classified, a new classification record is created. The supplier profile’s Classification tab displays:

• Current Classification — the most recent classification with full dimension scores, risk score, category badge, classification date, and justification
• Classification History — a chronological list of all previous classifications showing category, score, date, and which entry is current

Tip

Reclassify a supplier whenever there is a significant change in the scope of materials or services they provide, or when periodic review indicates a change in risk profile.

How Classification Affects Other Modules

• Requirements — Risk category determines which qualification requirements are auto-assigned to the supplier. Use the “Auto-assign Requirements” button on the Requirements tab after classification.
• Qualification frequency — Higher-risk suppliers typically require more frequent requalification cycles.
• Monitoring — Critical and Major suppliers appear prominently in dashboard statistics and overdue alerts.

Caution

A supplier without a classification will show “Not classified” in the supplier list. Classification should be completed before proceeding with qualification.