End‑to‑End Material Traceability with Continuous Risk Alerts

Unify N‑tier suppliers, BOMs, and lots into a single graph with always‑on alerting so you can spot issues earlier, contain faster, and stay audit‑ready.

Why it matters - UFLPA dossiers and supplier attestations centralized alongside certificates and COIs - N‑tier BOM mapping and lot genealogy to pinpoint upstream/downstream impact instantly - Recall workflows from detection to CAPA with preserved evidence and deadlines

Exhibit — BOM/Lot Propagation Alert

Alert: BOM/Lot Propagation Detected
Severity: High
Context:

- Part: P‑18422 (Spec Rev C)

- BOM: A12‑CX (effectivity overlap detected)

- Lot/Batch: L‑90731 (used in 6 open WOs, 3 shipped orders)

- Trigger: NCR (Major) on supplier Site S‑447; cert ISO 9001 expiring in 21 days
Auto‑Actions:

- Hold shipments for affected lots

- Create Trello tasks for containment and rework with due dates (48h SLA)

- Notify Quality + Engineering in Microsoft Teams and Slack

- Tag related SKUs for Packaging audits; generate deviation report in Google Docs

- Preserve alert, decisions, and attachments for audit trail

Explore how this connects with packaging material traceability and pharma recall management: Consumer Goods & Packaging • Pharma Compliance Suite

What end‑to‑end traceability with real‑time alerts delivers

Parakeet Risk connects suppliers, manufacturing sites, parts/BOMs, and lots/batches into a single traceability graph, then layers real‑time alerting and workflow automation on top. The result is faster issue detection, tighter recall containment, and audit‑ready documentation across packaging, manufacturing, and pharma operations. See material traceability and audit trail capabilities on the packaging page and quality/QMS integrations and recall management on the pharma page. Consumer Goods & Packaging • Pharma Compliance Suite

Data model for an industrial traceability graph

Parakeet models the lifecycle from sourcing to shipment so you can answer: What suppliers and sites touched this part? Which batches, work orders, and customers are affected? Where are the records?

Supplier ──→ Site/Plant ──→ Part/Material ──→ BOM/Recipe ──→ Lot/Batch ──→ (optional) Unit/Serial → Shipment/Customer
   ▲            │               │                 │                │
   │            ├──── IoT/QA ───┴──── specs ──────┴──── COA/NCR ───┘
   └── Certificates/COI, contracts

Single source of truth comes from your operational systems via Parakeet integrations and spreadsheet augmentation (no rip‑and‑replace required). Integrations • NetSuite • Google Docs

Real‑time alerting architecture

Parakeet routes high‑signal alerts to the right people, in the right tools, with full context and an auditable trail.

• Event detection: ERP/QMS updates, certification changes, QA/NCR creation, lot genealogy changes, and scheduled checks. Features

• Channel delivery: Slack, Microsoft Teams, WhatsApp for mobile, and Trello tasking with two‑way sync for remediation. Slack • Microsoft Teams • WhatsApp • Trello

• Scheduling & deadlines: Regulatory and audit dates auto‑populate calendars. Google Calendar

• Contextual intelligence: Rosella AI adds regulatory references, prior incidents, and similar CAPAs to speed triage and documentation. Rosella AI Agent

• Evidence & audit trails: All alerts, decisions, and attachments are preserved for audits and recalls. Packaging

Example alert triggers and auto‑workflows

• Certificate or compliance expiry (supplier/site): If ISO 9001 or COI is expiring in ≤ 30 days, notify vendor owner, open Trello task, and block new POs until renewed. Certification Automation

• Nonconforming material (NCR) raised on a critical part: Tag impacted BOMs and open containment tasks for work orders using the lot/batch.

• BOM change with effectivity overlap: Alert engineering, quality, and production; require dual sign‑off and regenerate traveler documents in Google Docs.

• Temperature/excursion or QA test failure on a batch: Page QA lead in Slack/Teams, hold shipment, and auto‑generate a deviation record.

• Recall keyword in regulator update (FDA/EMA) tied to your product class: Rosella summarizes the rule change and tags affected SKUs and markets. Pharma

Sample recall playbook (ready‑to‑run)

This playbook operationalizes traceability with measurable handoffs, audit evidence, and regulator‑ready outputs. 1) Detect and classify (T0–30 min)

• Trigger: NCR severity ≥ Major, customer complaint, or regulator bulletin referencing your product code.

• Actions: Create Parakeet incident, assign Incident Lead (Quality), auto‑spin a Teams/Slack channel, link impacted lots via genealogy lookup.

2) Contain and verify scope (T+30–90 min)

• Run Rosella “similar incidents” and regulation summary; compute affected lots/batches and open POs/WOs/customers.

• Place ship‑holds in ERP and notify Logistics; log evidence and timestamps.

3) Decide recall level and notify (T+2–6 hours)

• Convene decision board; template letters generated in Google Docs; calendar deadlines scheduled for regulator submissions. Google Docs • Google Calendar

• Customer notifications distributed; WhatsApp used for field escalation where needed. WhatsApp

4) Execute retrieval and rework (Day 1–5)

• Track returns by lot; reconcile counts; manage rework/retirement work orders; maintain chain‑of‑custody.

• All tasks managed in Trello with two‑way status back to Parakeet for audit. Trello

5) Close, CAPA, and learn (≤ Day 10)

• Root cause documented; CAPAs assigned; effectiveness checks scheduled.

• Final regulatory packet exported; evidence preserved under 21 CFR Part 11‑aligned controls (pharma). Pharma

Implementation blueprint

• Connect data: ERP/NetSuite, QMS/QA logs, vendor certificates/COI; continue leveraging spreadsheets with audit trails instead of replacing them. NetSuite • Features

• Map identifiers: Normalize supplier, site, part, BOM, lot/batch IDs; define effectivity and revision semantics.

• Define alert policies: Who gets notified for which triggers, channels, and SLAs; set thresholds to minimize noise. Slack • Microsoft Teams

• Automate documents: Generate NCRs, deviation reports, recall notices, and CAPA forms from approved templates. Google Docs

• Exercise readiness: Run Table Top Exercises and iterate on gaps; keep audit packets evergreen. Continuous Compliance

Compliance, audit readiness, and data integrity

• Packaging and consumer goods: End‑to‑end material traceability, supplier performance monitoring, and documentation for audits. Packaging

• Pharma: Real‑time FDA/EMA tracking, QMS integration for deviations/CAPA/change control, and data integrity alignment with 21 CFR Part 11. Pharma

• Continuous evidence: Every alert, decision, and artifact is retained with timestamps and owners to prove due diligence.

KPIs you can track in Parakeet

• Time to identify affected lots/batches after a trigger

• Mean time to containment (MTC) and to notify (MTN)

• Percentage of recalls with complete genealogy evidence at decision time

• Supplier compliance rate (certifications, COI) and on‑time renewals

• Audit preparation time saved and closed‑loop CAPA effectiveness. Features • ROI Tracking

Why Parakeet Risk for traceability + alerts

• Industrial‑specific AI: Rosella understands manufacturing, packaging, and pharma risk patterns and regulations. Rosella

• Spreadsheet synergy: Keep existing Excel‑based knowledge while adding governance, automation, and audit trails. Features

• Unified risk ecosystem: ERP, HRIS, financials, collaboration, and mobile channels integrated for end‑to‑end visibility. Integrations

• Measurable ROI: Track time saved, reduced rework, and faster audits with live dashboards. ROI