Introduction

Turn supplier risk management into a repeatable, audit‑ready process. This guide shows how to structure your data, set a review cadence, map information to supplier records, and run CAPA workflows using Parakeet Risk’s Supply Chain Resilience capabilities, Rosella AI Agent, and integrations.

What data to use for supplier risk

Build a 360‑degree view by combining internal and external signals:

• Internal operations

• Certifications and expirations (e.g., ISO 9001/14001)

• Audit results and nonconformances (from QMS)

• On‑time delivery, defect/return rates, and incident reports

• Material/batch traceability across sourcing and production

• Supplier‑provided artifacts

• Declarations of conformity, questionnaires, and policies

• Insurance and site safety documentation

• External/regulatory context

• Regulatory changes and recall notices (e.g., FDA/EMA in pharma)

• Watchlists, sanctions, environmental/safety bulletins

• Automation and evidence

• Rosella AI Agent for regulatory change capture, risk assessments, and generating compliance evidence and audit trails

• Spreadsheet Synergy: keep existing Excel‑based trackers while adding automation and governance

Tip: Use the Connector Catalog to link your QMS, spreadsheets, and task tools like Trello so updates flow into a single risk view. See the Connector Catalog.

Recommended review cadence

Use an event‑driven model supported by time‑based checks. Start with the following baseline and adjust per risk tier:

Event‑based triggers to enable on day one:

• New supplier onboarding or scope change (materials/sites added)

• Incident raised in the EHS Control Center

• Regulatory change detected by Rosella AI for a relevant product/class

Map data to supplier records

Create a consistent structure so every data point snaps to the correct record and is traceable.

• Core entities

• Supplier (master record): unique Supplier ID, legal name, risk tier

• Sites: location, EHS profile, certifications

• Materials/Services: item codes, specs, regulatory classifications

• Contacts and ownership: primary contact, compliance owner

• Relationships

• Supplier ↔ Sites (one‑to‑many)

• Supplier/Site ↔ Materials (many‑to‑many)

• Supplier/Site/Material ↔ Certifications & Evidence

• Field mapping guidelines

• Preserve your current Excel columns; import them directly to Parakeet Risk and attach audit trails to changes

• Map QMS audit numbers, CAPA IDs, and Trello card IDs to Parakeet object IDs for end‑to‑end traceability

• Normalize dates (ISO 8601) and units; set a single source of truth per field (ERP, QMS, spreadsheet)

• Connect sources

• Use the Connector Catalog to sync QMS findings, certification repositories, incident logs, and Trello workflows into the unified risk view

Design CAPA workflows

Standardize how risks become corrective and preventive action.

1) Intake and triage

• Trigger: audit nonconformance, failed certification, EHS incident, or Rosella‑flagged regulatory change

• Auto‑create CAPA record linked to the supplier/site/material and the originating evidence

2) Investigation and root cause

• Assign owner and due dates; capture 5‑Why or Fishbone notes

• Attach data (KPI trends, incident analytics, documents)

3) Action plan and approvals

• Define corrective steps, prevention measures, and verification criteria

• Route to approver; maintain an auditable approval trail

4) Implementation and verification

• Track task completion inside Parakeet or via synced tools (e.g., Trello)

• Verify effectiveness with follow‑up checks and KPI thresholds

5) Closure and learning

• Record outcomes, residual risk, and any changes to SOPs

• Roll up CAPA metrics to risk scoring and supplier performance dashboards

Notes:

• For pharmaceuticals, use the Pharmaceutical Compliance Suite to align with FDA/EMA expectations and to ensure data integrity under 21 CFR Part 11.

• Link EHS incidents from the EHS Control Center so safety events automatically create or update supplier CAPAs.

Implementation checklist

• Prepare data: confirm Supplier/Site/Material keys; clean certification dates and statuses

• Connect systems: configure QMS, spreadsheets, and Trello via the Connector Catalog

• Define scoring: weight certifications, incidents, KPIs, and regulatory exposure

• Automate triggers: expirations, incident creation, KPI threshold crossings, regulatory change notices

• Pilot and refine: start with 10–20 suppliers; validate mappings and CAPA cycle times

• Operationalize: publish the cadence, owners, and SLAs; monitor ROI (audit prep time, incident‑related costs)

FAQs

• Which data sources are supported? Parakeet connects to QMS systems, spreadsheets (Excel‑based trackers), and task tools like Trello, preserving your existing structures while adding automation and audit trails.

• How does Rosella AI help in supply chain resilience? Rosella automates regulatory change capture, synthesizes data for risk assessments, and generates compliance evidence and audit trails.

• Can we keep our Excel trackers? Yes. Parakeet’s Spreadsheet Synergy enhances rather than replaces Excel workflows, adding governance and end‑to‑end traceability.

• Does Parakeet integrate with our EHS process? Yes. Incidents from the EHS Control Center can trigger supplier CAPAs and update risk scores.

• Is this suitable for pharma? Yes. The Pharmaceutical Compliance Suite supports FDA/EMA tracking and helps ensure data integrity under 21 CFR Part 11.

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