This section establishes complete traceability for the contamination event. All fields are critical for effective recall management and investigation. Provide exact information as shown on production records.
Date and Time of Discovery
Production Line Identifier
Shift During Discovery
Day Shift (06:00-14:00)
Evening Shift (14:00-22:00)
Night Shift (22:00-06:00)
Weekend/Holiday Shift
Product Name
Product SKU/Code Number
Lot/Batch Number
Production Date of Affected Lot
Production Start Time for Affected Lot
Production End Time for Affected Lot
Specific Equipment or Station Where Contaminant Was Discovered
Packaging Type
Primary Packaging Only
Secondary Packaging
Bulk/Intermediate
Finished Retail Package
Not Yet Packaged
Allergen Status of Affected Product
Contains No Allergens
Contains Gluten
Contains Dairy
Contains Soy
Contains Nuts
Contains Shellfish
Contains Eggs
Contains Other Allergens
Total Quantity Produced in Affected Lot (in kg or units)
Customer Name (if produced for specific customer)
Customer Order Number (if applicable)
All Personnel Present at Time of Discovery
Immediate Supervisor Notified
Provide precise physical characteristics of the foreign material. Accurate documentation is essential for root cause analysis and supplier investigation. Photographic evidence is mandatory.
Contaminant Material Type
Metal
Glass
Plastic
Other Foreign Material
Metal Type
Ferrous (magnetic)
Non-Ferrous (non-magnetic)
Stainless Steel
Aluminum
Unknown Metal
Glass Type
Clear Glass
Amber Glass
Green Glass
Tempered Glass
Mirrored Glass
Unknown Glass
Plastic Type (if identifiable)
Hard Plastic (e.g., polycarbonate)
Soft Plastic (e.g., polyethylene)
Silicone
Rubber
Plastic Film
Unknown Plastic
Describe Other Foreign Material
Discovery Method
Visual Inspection by Operator
Metal Detector Alarm
X-Ray System Alarm
Customer Complaint
Routine QA Sampling
Third-Party Testing
Other Detection Method
Contaminant Length (in millimeters)
Contaminant Width/Diameter (in millimeters)
Contaminant Thickness (in millimeters)
Contaminant Weight (in grams)
Color and Appearance Description
Upload Clear Photograph of Contaminant (mandatory)
Upload Additional Photographs from Multiple Angles
Total Number of Fragments Found
Exact Location on Product or Equipment Where Found
Production Stage at Discovery
Raw Material Intake
Pre-Processing
During Processing
Post-Processing
Primary Packaging
Secondary Packaging
Finished Goods Storage
Shipping
Was Contaminant Embedded in Product?
Describe Product Matrix and Embedding Depth
Describe How Contaminant Was Separate from Product
Potential Source of Contamination (initial assessment)
Does Contaminant Exceed Internal Foreign Material Standards?
Specify Standard Limit and Measured Value
Explain Why Standard Was Not Exceeded But Product Still Quarantined
Is Reference Sample Available for Comparison?
Reference Sample Identification Number
Immediate Actions Taken Upon Discovery
Document all containment actions taken to prevent affected product from reaching customers. Precise inventory control is mandatory for effective product hold and potential recall management.
Was Production Line Immediately Shut Down?
Exact Time of Line Shutdown
Justify Why Line Shutdown Was Not Required
Line Status at Time of Discovery
Running Production
Startup/Changeover
Cleaning/Sanitization
Maintenance
Idle/Not Operating
Was Formal Product Hold/Quarantine Initiated?
Total Quantity Placed on Hold (kg or units)
Explain Why Formal Hold Was Not Initiated
Product Stages Affected by Quarantine
Work-in-Progress (WIP)
Finished Product (Unpacked)
Primary Packaged Product
Secondary Packaged Product
Palletized Finished Goods
Product in Cold Storage
Product in Distribution Center
Physical Location(s) of Quarantined Product
Hold/Quarantine Tag Numbers Applied
Detailed Inventory of Quarantined Product
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Has Any Product from This Lot Already Been Distributed?
Quantity Already Distributed (kg or units)
Is Customer Notification Required for Distributed Product?
List Affected Customers and Contact Status
Initial Product Disposition Decision
Hold Pending Investigation
Rework Under QA Supervision
Release After Risk Assessment
Destroy/Reject
Redirect to Lower-Risk Application
Justification for Release Decision
Has Affected Product Been Physically Segregated from Good Product?
Explain Segregation Plan and Timeline
Additional Containment Actions Taken
Complete verification of all detection equipment that should have identified the contaminant. This analysis determines if equipment failure contributed to the incident.
Detection Equipment Present on Production Line
Metal Detector
X-Ray Inspection System
Vision System
Manual Inspection Station
No Automated Detection
Metal Detector Equipment ID/Serial Number
X-Ray Equipment ID/Serial Number
Last Scheduled Calibration Date
Last Validation/Performance Qualification Date
Last Routine Check (e.g., start of shift) Time
Was Detection Equipment Functioning Normally at Discovery?
Describe Equipment Malfunction or Abnormality
Metal Detector Sensitivity Settings (e.g., Fe 1.5mm, Non-Fe 2.0mm, SS 2.5mm)
X-Ray Detection Settings (e.g., density threshold, contaminant size)
Test Piece Sizes Used in Routine Checks
Was Immediate Calibration Check Performed After Discovery?
Calibration Check Performed By
Justify Why Immediate Check Was Not Performed
Calibration Check Results
Pass - Within Specification
Fail - Out of Specification
Inconclusive - Requires Further Analysis
Not Applicable - No Equipment Present
Describe Calibration Failure Details
Were Any Equipment Deviations or Maintenance Issues Identified?
Detail Equipment Deviations and Corrective Actions Taken
Technician Name and Qualifications
Was Equipment Re-Calibration or Repair Required?
Re-Calibration/Repair Completion Time
Was Post-Repair Verification Test Successful?
Standard Operating Procedure Reference Number for Calibration
Equipment Maintenance History Review (last 30 days)
Final authorization section. All contamination incidents require dual approval from Quality Assurance and Operations leadership before product disposition and line restart. Ensure all investigations are complete before signing.
Plant QA Lead Name
QA Lead Review Date and Time
QA Lead Approval Status
Approved - Investigation Complete
Approved with Conditions
Rejected - Investigation Incomplete
Pending Further Analysis
Specify Conditions for Approval
Specify Required Additional Information
QA Lead Comments and Risk Assessment Summary
Operations Director Name
Operations Director Review Date and Time
Operations Director Approval Status
Approved - Line Restart Authorized
Approved with Restrictions
Rejected - Line Cannot Restart
Pending CAPA Implementation
Specify Restart Restrictions
Specify Conditions for Future Restart
Operations Director Comments and Resource Allocation
Final Product Disposition Decision (Dual Approved)
Release to Market
Hold Indefinitely
Rework Under QA Supervision
Destroy Under Witnessed Conditions
Downgrade to Non-Food Use
Return to Supplier
Is Product Release Authorization Granted?
Release Authorization Number
Explain Continued Hold or Destruction Rationale
Is Investigation Officially Closed?
Target Investigation Completion Date
Has Corrective and Preventive Action (CAPA) Plan Been Approved?
Specify CAPA Plan Status and Next Steps
Is Effectiveness Monitoring Required Post-Closure?
Specify Monitoring Plan and Frequency
QA Lead Digital Signature
Operations Director Digital Signature
Conduct thorough root cause analysis using systematic methods. Identify all contributing factors to prevent recurrence. This section must be completed within 72 hours of incident discovery.
Primary Root Cause Category
Supplier Raw Material Contamination
Equipment Failure/Deterioration
Maintenance Activity
Human Error/Behavior
Environmental Contamination
Process Design Flaw
Packaging Material Defect
Unknown/Unidentified
Contributing Factors
Inadequate Supplier Controls
Equipment Not Fit for Purpose
Lack of Preventive Maintenance
Insufficient Training
Poor Housekeeping
Process Too Complex
Inadequate Detection Sensitivity
High Production Pressure
Communication Breakdown
Other Factor
Equipment Failure Analysis (if applicable)
Does Investigation Involve Supplier?
Supplier Name, Material Batch, and Communication Status
Does Investigation Indicate Human Factor?
Human Factor Type
Procedural Violation
Lack of Competency
Inadequate Supervision
Fatigue/High Workload
Miscommunication
Intentional Act
Environmental Factor Involved?
Describe Environmental Condition
Timeline of Events (from production start to discovery)
Develop comprehensive CAPA plan addressing root cause and all contributing factors. Actions must be specific, measurable, achievable, relevant, and time-bound (SMART).
Immediate Corrective Actions Taken (within 24 hours)
Preventive Actions to Avoid Recurrence
CAPA Action Plan with Responsibilities
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Are Resources Adequately Allocated for CAPA Implementation?
Document all internal and external notifications. Regulatory and customer notification decisions must be made jointly by QA and Operations leadership within 24 hours.
Internal Notifications Completed
Plant Management
Corporate Quality
Corporate Operations
Procurement
Maintenance
R&D
Legal Department
Not Notified Internally
External Notification Required?
External Entities Notified
Regulatory Authority
Customer(s)
Supplier
Third-Party Auditor
Insurance
Notified External Party
Regulatory Authority Notification Required?
Authority Name, Notification Date, and Reference Number
Customer Notification Completed?
Customer Notification Details
Customer Name | Notification Date/Time | Contact Person | Response Received | ||
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Upload Copies of All Notification Records and Correspondence
Final verification ensures all actions are completed and effectiveness is monitored. Form closure requires confirmation that all critical steps have been executed and documented.
Verification Activities Completed
Line restart verification
Detection equipment validation
Staff re-training verification
Supplier corrective action review
Effectiveness check at 30 days
Effectiveness check at 90 days
Audit of improved controls
Effectiveness Monitoring Check Date
Follow-Up Inspection Confirmed Control Effectiveness?
Form Completed By
Form Completion Date and Time
Form Completer Signature
To configure an element, select it on the form.