Product Traceability & Lot Control Checklist [FREE PDF]
Quality managers and production supervisors use this checklist per ISO 9001:2015 Clause 8.5.2 identification and traceability requirements for maintaining lot control throughout manufacturing.
- Industry: Manufacturing
- Frequency: Weekly
- Estimated Time: 10-15 minutes
- Role: Quality Manager
- Total Items: 8
- Compliance: ISO 9001:2015 Clause 8.5.2, FDA 21 CFR 820.86
Lot Identification & Marking
Verify lot identification and marking practices.
- Are all materials and WIP identified with lot/batch numbers throughout production?
- Can raw material lot numbers be traced to finished product lot numbers?
- Are lot segregation practices preventing commingling of different lots?
- Lot identification notes
Recall Readiness & Mock Recall
Verify traceability system supports recall readiness.
- Has a mock recall been conducted within the past 12 months with results documented?
- Can forward traceability identify all customers who received a specific lot?
- Can the full trace (raw material to customer) be completed within target time (typically 4 hours)?
- Recall readiness notes
Related Quality Assurance Checklists
- Supplier Audit Program Compliance Checklist [FREE PDF]
- Security Officer Performance Evaluation Checklist
- Security Risk Assessment Checklist
- CCTV Compliance and Privacy Audit Checklist
- Aviation Tool Control & FOD Prevention Checklist
- Fiber Splicing Quality & Safety Checklist
- False Alarm Reduction Program Audit Checklist
- Executive Protection Threat Intelligence Assessment Checklist
Related Compliance Checklists
- Security Officer Performance Evaluation Checklist - FREE Download
- Security Risk Assessment Checklist - FREE Download
- CCTV Compliance and Privacy Audit Checklist - FREE Download
- False Alarm Reduction Program Audit Checklist - FREE Download
- Executive Protection Threat Intelligence Assessment Checklist - FREE Download
- Post-Event Security Debrief and After-Action Report Checklist - FREE Download
- Employee Theft Investigation Checklist - FREE Download
- CCTV Footage Review and Evidence Export Checklist - FREE Download
- Vendor and Supplier Fraud Detection Checklist - FREE Download
- Corporate Internal Investigation Protocol Checklist - FREE Download
Why Use This Product Traceability & Lot Control Checklist [FREE PDF]?
This product traceability & lot control checklist [free pdf] helps manufacturing teams maintain compliance and operational excellence. Designed for quality manager professionals, this checklist covers 8 critical inspection points across 2 sections. Recommended frequency: weekly.
Ensures compliance with ISO 9001:2015 Clause 8.5.2, FDA 21 CFR 820.86. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Product Traceability & Lot Control Checklist [FREE PDF] cover?
This checklist covers 8 inspection items across 2 sections: Lot Identification & Marking, Recall Readiness & Mock Recall. It is designed for manufacturing operations and compliance.
How often should this checklist be completed?
This checklist should be completed weekly. Each completion takes approximately 10-15 minutes.
Who should use this Product Traceability & Lot Control Checklist [FREE PDF]?
This checklist is designed for Quality Manager professionals in the manufacturing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.