Identification and Traceability
ISO 9001:2015 – Section 8.5.2
Our consultancy approach ensures that organizations establish and maintain proper identification and traceability methods throughout production and service provision. This guarantees that products, services, and related documentation are clearly identifiable and traceable where required, preventing mix-ups, ensuring accountability, and supporting regulatory or customer requirements.
Scope of Work
1. Product/Service Identification
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• Define methods to identify outputs during every stage of production and service delivery.
• Use labels, barcodes, digital tracking systems, or unique identifiers.
• Ensure identification aligns with specifications, drawings, and customer requirements.
2. Traceability Systems
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• Establish traceability procedures for products, batches, lots, or serialized items where required.
• Maintain linkages between product, records, and responsible personnel.
• Apply traceability in compliance with legal, regulatory, or customer-specific obligations.
3. Status Control
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• Clearly indicate product/service conformity status (e.g., pending, approved, rejected).
• Use visual indicators, electronic systems, or tagging methods.
• Maintain records of inspections, approvals, and testing stages.
4. Record Management
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• Ensure records demonstrate traceability of outputs to their origin.
• Implement controls for secure storage, retrieval, and retention of traceability data.
• Provide evidence for audits, customer queries, or recalls.
Deliverables
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• Identification and traceability procedures.
• Output status registers and approval logs.
• Records linking products/services to responsible personnel.
• Traceability matrix for regulatory/customer compliance.
• Templates for labels, batch records, and system tracking.
Pricing & Timeline
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• Fee: $3,150.00/month per facility (6-month engagement)
• Estimated Duration: 180 business days
Completion timeline may vary based on client responsiveness and documentation turnaround.
Sample Milestone Plan
| Phase | Key Activities | Core Deliverables |
|---|---|---|
| Month 1 – Planning | Kick-off, scope definition, project charter |
✓ Implementation Plan ✓ Scope Statement & Team Roles |
| Months 1–2 – Design | FSMS drafting, PRP setup, document control systems |
✓ SOPs, PRPs ✓ Controlled Document Framework |
| Months 2–3 – Execution | Competency training, system rollout, records logging |
✓ Training Logs ✓ First Cycle Recordkeeping Evidence |
| Months 3–6 – Validation | Internal audits, reviews, performance monitoring |
✓ Internal Audit Reports ✓ CAPA Logs ✓ Management Review |
| Month 6 – Readiness | Final system check, CB coordination, mock audit |
✓ Pre-Audit Summary ✓ Final CAPA Log ✓ Audit-Day Prep |
Certification Audit Support
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• On-site or remote audit-day presence
• Real-time response to auditor inquiries
• Post-audit support and non-conformance response drafting
Deliverables:
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✓ Audit Representation
✓ NC Response Support
✓ Audit Day Documentation
Project Closure
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• Final FSMS documentation handover
• Executive summary outlining system status and sustainability plan
• Option to transition into maintenance & continuous improvement support
Deliverables:
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✓ Final Document Handover
✓ Close-Out Report
✓ Maintenance Plan Proposal
Additional Compliance Support Options
| Service | Description | Fee |
|---|---|---|
| Traceability Implementation Package | End-to-end system setup for product/service identification and traceability. | $1,800/system |
| Digital Tracking & Barcode Toolkit | Tools and templates for barcode/QR code integration and system registers. | $1,400/project |
| Status Control Templates | Ready-to-use logs and templates for monitoring conformity status. | $1,200/project |
| Traceability Records Management Bundle | Structured registers and retention schedules for traceability records. | $950 |
