Supplier Classification & Settings

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

Classify a supplier

1. On the left sidebar, select Suppliers.
2. Select the supplier you want to classify.
3. On the supplier detail page, select Classify Supplier.
4. For each of the five risk dimensions, select 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

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 (required).
7. Select Submit Classification.

Caution

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

Tip

For detailed step-by-step classification instructions including dimension definitions, scoring examples, and practical walkthroughs, see Supplier Classification.

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.

Edit supplier information

1. On the left sidebar, select Suppliers.
2. Select the supplier you want to edit.
3. On the supplier detail page, select Edit.
4. Modify the fields described below.
5. Select Save.

Basic information

• Supplier Name and Trade Name
• Country of origin
• Supplier Types (selectable from configured options)

Contacts

Each supplier supports four contact categories. For each contact, enter the name, email, and phone number:

• 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

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

Enter the full registered address including street, city, state/province, postal code, and country.

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.

Practical example: Classify a new active pharmaceutical ingredient (API) supplier

Your procurement team has qualified a new API supplier. You need to classify them before placing the first order.

1. Navigate to Suppliers and select the new supplier “PharmaChem GmbH”.
2. Select Classify Supplier and rate each dimension:
   • Impact on Product Quality: High (3) — API directly determines drug substance purity.
   • Impact on Patient Safety: High (3) — impurities in the API could harm patients.
   • Regulatory Impact: High (3) — supplier must comply with EU GMP Part II and FDA guidance for APIs.
   • Process Criticality: Medium (2) — alternative suppliers exist but switching takes 6+ months.
   • Data Integrity Risk: Medium (2) — supplier provides Certificates of Analysis with GxP-relevant data.
3. The Classification Preview shows a total score of 13 and a Critical risk category.
4. Enter the justification: “API supplier for lead product. Direct impact on drug substance quality. Subject to EU GMP Part II. CoA data is GxP-relevant. Alternative suppliers available but long qualification timeline.”
5. Select Submit Classification.

The Critical classification means this supplier requires annual on-site audits, full qualification documentation, and ongoing performance monitoring — all of which InnoQualis tracks automatically.

Permissions

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