Food Manufacturing X-Ray Inspection Check [FREE PDF]

X-ray inspection systems are a critical control point (CCP) under HACCP principles and must be validated and monitored per FDA FSMA 21 CFR 117 Subpart C preventive controls requirements. Operators must verify detection sensitivity, rejection mechanisms, and recordkeeping for each product type processed. SQF Code Edition 9 and BRC Global Standard Issue 9 both mandate documented foreign body detection programs with defined alert and action limits.

Industry: Food Manufacturing
Frequency: Per Event
Estimated Time: 20-35 minutes
Role: QA Manager
Total Items: 31
Compliance: FDA FSMA 21 CFR 117 Subpart C - Hazard Analysis and Risk-Based Preventive Controls, HACCP Codex Alimentarius CAC/RCP 1-1969 Rev. 4-2003 - CCP Monitoring Procedures, SQF Code Edition 9 Module 11 - Food Safety Fundamentals, BRC Global Standard for Food Safety Issue 9 Clause 6.1.5 - Metal/Foreign Body Detection, GMP 21 CFR 110.80 - Processes and Controls

Equipment Setup & Pre-Run Verification

Confirm the X-ray unit is properly configured, powered, and set to the correct product program before production begins.

Is the X-ray machine model and serial number logged in the inspection record?
Has the correct product program been selected on the X-ray system controller?
Is the X-ray beam energy level and conveyor speed set per the validated product specification?
Is the reject mechanism (pusher/air blast/diverter) fully operational and tested prior to run?
Has the reject bin been confirmed empty and properly positioned before production start?

Test Piece Calibration & Sensitivity Verification

Validate that the X-ray system detects contaminants at or below the minimum detectable size using certified test pieces.

Have certified X-ray test pieces (glass, metal, bone, stone) been used for the sensitivity check?
Did the system correctly detect and reject all test pieces passed through at the start of the run?
What is the minimum detectable size (mm) recorded for the metal test piece?
Was calibration performed within the required interval (per SOPs, typically every 30–60 minutes)?
Are calibration test results recorded in the designated X-ray log with time stamps?

Contaminant Detection Performance

Assess system performance across contaminant categories relevant to the product and packaging format.

Is the system capable of detecting glass fragments at the specification limit for this product?
Is the system validated for calcified bone detection relevant to the product being run (if applicable)?
Is the system capable of detecting high-density plastics or stone at the required sensitivity?
Has any product density variation been accounted for in the contaminant detection threshold settings?
Are false reject rates monitored and within acceptable limits (e.g., <0.5% per shift)?

Rejection & Quarantine Handling

Verify that all rejected product is handled, quarantined, and investigated per documented procedures.

Is all rejected product immediately placed into a labeled, locked quarantine container?
Is each rejection event logged with time, product lot, and quantity rejected?
Has every rejected unit been inspected to confirm or identify the foreign body?
Has a corrective action report (CAR) been initiated for any detection of an actual contaminant?
Is disposition of all rejected product documented and authorized by QA before release or destruction?

Equipment Condition & Maintenance

Inspect the physical condition of the X-ray unit for cleanliness, integrity, and maintenance compliance.

Is the conveyor belt free of product residue, tears, or damage that could affect detection accuracy?
Are X-ray aperture curtains/flaps intact and free of holes or excessive wear?
Is the equipment listed in the Preventive Maintenance schedule and current on all PM tasks?
Are radiation warning labels and safety signage visible and undamaged on the unit?
Has a photo of the current equipment condition been captured for the inspection record?

Recordkeeping & Documentation

Confirm that all required records are complete, legible, and stored in compliance with regulatory retention requirements.

Are X-ray inspection logs completed in real time (not back-filled) by the designated operator?
Do records include all required fields: product, lot, time, operator, test results, and deviations?
Are records signed or electronically authenticated by the QA reviewer within the required timeframe?
Are X-ray system records retained for a minimum of 2 years (or per customer/standard requirement)?
Are there any open non-conformances from the previous inspection that remain unresolved?
Please provide any additional observations or notes regarding today's X-ray inspection.

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Why Use This Food Manufacturing X-Ray Inspection Check [FREE PDF]?

This food manufacturing x-ray inspection check [free pdf] helps food manufacturing teams maintain compliance and operational excellence. Designed for qa manager professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: per event.

Ensures compliance with FDA FSMA 21 CFR 117 Subpart C - Hazard Analysis and Risk-Based Preventive Controls, HACCP Codex Alimentarius CAC/RCP 1-1969 Rev. 4-2003 - CCP Monitoring Procedures, SQF Code Edition 9 Module 11 - Food Safety Fundamentals, BRC Global Standard for Food Safety Issue 9 Clause 6.1.5 - Metal/Foreign Body Detection, GMP 21 CFR 110.80 - Processes and Controls. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Food Manufacturing X-Ray Inspection Check [FREE PDF] cover?

This checklist covers 31 inspection items across 6 sections: Equipment Setup & Pre-Run Verification, Test Piece Calibration & Sensitivity Verification, Contaminant Detection Performance, Rejection & Quarantine Handling, Equipment Condition & Maintenance, Recordkeeping & Documentation. It is designed for food manufacturing operations and compliance.

How often should this checklist be completed?

This checklist should be completed per event. Each completion takes approximately 20-35 minutes.

Who should use this Food Manufacturing X-Ray Inspection Check [FREE PDF]?

This checklist is designed for QA Manager professionals in the food 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.