Supplier Classification & Settings

The supplier classification system provides a structured, risk-based approach to evaluating and categorizing suppliers. Each supplier is assessed across multiple dimensions to produce a risk category that determines the level of oversight, audit frequency, and documentation requirements.

Risk Assessment Dimensions

When classifying a supplier, you evaluate five dimensions. Each dimension is rated as High, Medium, or Low.

Dimension	What It Measures
Impact on Product Quality	How directly the supplier affects the quality of the final product
Impact on Patient Safety	Whether a supplier failure could impact patient safety
Regulatory Impact	The regulatory consequences if the supplier fails to meet requirements
Process Criticality	How critical the supplier is to manufacturing or business processes
Data Integrity Risk	Whether the supplier handles data that impacts GxP compliance or data integrity

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How Classification Scoring Works

Each rating maps to a numeric score:

• High = 3 points
• Medium = 2 points
• Low = 1 point

The total score across all five dimensions determines the risk category:

Total Score	Risk Category
12 — 15	Critical
8 — 11	Major
4 — 7	Minor
1 — 3	Non-Critical

Note

The classification preview shown on screen is a client-side estimate. The server calculates the final score using configurable weights, which may produce a different result if your administrator has customized dimension weights.

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Classifying a Supplier

1. Navigate to Suppliers from the sidebar.
2. Select the supplier you want to classify.
3. Click Classify or navigate to the classification page from the supplier detail view.
4. For each of the five risk dimensions, select High, Medium, or Low by clicking the corresponding option.
5. Review the Classification Preview card, which shows the estimated risk category and total score.
6. Enter a Justification explaining the reasoning behind your classification. This field is required.
7. Click Submit Classification.

Caution

A justification is mandatory. The system will not accept a classification without one. Include relevant context such as product types supplied, historical performance, or regulatory considerations.

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Supplier Information Management

When editing a supplier, you can configure the following details:

Basic Information

• Supplier name and trade name
• Country of origin
• Supplier types (selectable from configured options)

Contacts

Each supplier supports four contact categories:

• Quality Contact — Primary contact for quality-related matters
• Regulatory Contact — Contact for regulatory affairs
• Commercial Contact — Business and procurement contact
• Emergency Contact — For urgent supplier issues

Each contact record includes name, email, and phone number.

Regulatory Configuration

• Regulatory Regions — Select applicable regions (EU, US, CH, UK, JP, CN, AU, CA)
• Data Integrity Relevant — Flag whether the supplier handles GxP data
• Uses Computerized Systems — Flag whether the supplier uses systems subject to validation

Address

Full registered address including street, city, state/province, postal code, and country.

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Risk Category Implications

The assigned risk category affects how the supplier is managed across the system:

• Critical suppliers typically require the most frequent audits, detailed qualification documentation, and ongoing monitoring.
• Major suppliers require regular audits and qualification activities.
• Minor suppliers may be managed with periodic assessments.
• Non-Critical suppliers require minimal oversight.

Tip

Review supplier classifications periodically, especially after quality events, audit findings, or changes in the materials or services the supplier provides.

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Permissions

Supplier classification requires appropriate permissions. Typically, users with the suppliers.read permission can view supplier details, while classification and editing require elevated access. Contact your administrator if you cannot access the classification page.