Control of Quantity (Weight/Volume)
Aligned with FSSC 22000 – ISO/TS 22002-1:2009 Clause 8.3 and ISO 22000:2018 Clause 8.5.1
Requirement Overview
Under FSSC 22000, organizations must implement controls to ensure that declared product quantities (weight or volume) are accurate, comply with legal metrology requirements, and meet customer specifications.
Relevant requirements include:
• ISO/TS 22002-1 Clause 8.3 (Quantity, Weight, and Volume Control): Requires documented procedures to ensure net content accuracy and compliance with legal and customer standards.
• ISO 22000:2018 Clause 8.5.1 (Control of Production and Service Provision): Requires monitoring and verification of processes to ensure products meet defined requirements.
Accurate fill control protects regulatory compliance, prevents underfilling, reduces overfilling losses, and supports consumer trust.
Step-by-Step Compliance Implementation
1. Establish Quantity Control Procedures
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Procedures Should Include:
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• Target weight/volume per SKU with defined tolerances
• Legal and customer-specific requirements for quantity accuracy
• Verification methods and frequency for each production run
Evidence to Maintain:
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• Documented Quantity Control SOP)
• Target and tolerance specifications for each product
• Verification protocols and schedules
- • Target weight/volume per SKU with defined tolerances • Legal and customer-specific requirements for quantity accuracy • Verification methods and frequency for each production run
- • Documented Quantity Control SOP) • Target and tolerance specifications for each product • Verification protocols and schedules
2. Calibrate and Maintain Equipment
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Equipment Must Be:
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• Calibrated at defined intervals by qualified personnel
• Maintained to prevent measurement drift or dispensing errors
• Labeled with calibration and maintenance status
Evidence to Maintain:
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• Calibration certificates and service reports
• Preventive maintenance logs
• Equipment identification and calibration status labels
- • Calibrated at defined intervals by qualified personnel • Maintained to prevent measurement drift or dispensing errors • Labeled with calibration and maintenance status
- • Calibration certificates and service reports • Preventive maintenance logs • Equipment identification and calibration status labels
3. Conduct Regular Checks During Production
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Checks Should Cover:
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• Random in-process weight/volume checks by batch, lot, or shift
• Statistical sampling where applicable (e.g., control charts)
• Defined actions for out-of-spec results (e.g., product hold, equipment inspection)
Evidence to Maintain:
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• In-process quantity check logs
• Non-conformance records for deviations
• Corrective action reports and equipment adjustment records
- • Random in-process weight/volume checks by batch, lot, or shift • Statistical sampling where applicable (e.g., control charts) • Defined actions for out-of-spec results (e.g., product hold, equipment inspection)
- • In-process quantity check logs • Non-conformance records for deviations • Corrective action reports and equipment adjustment records
4. Train and Authorize Personnel
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Personnel Should:
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• Understand the importance of quantity control for compliance and consumer trust
• Be trained to operate equipment, conduct checks, and interpret results
• Be authorized to adjust settings or escalate issues as needed
Evidence to Maintain:
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• Training records for production and quality staff
• Authorization matrix for equipment adjustments and decision-making
- • Understand the importance of quantity control for compliance and consumer trust • Be trained to operate equipment, conduct checks, and interpret results • Be authorized to adjust settings or escalate issues as needed
- • Training records for production and quality staff • Authorization matrix for equipment adjustments and decision-making
5. Review, Trend, and Improve
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Analysis Activities Include:
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• Trending overfills, underfills, and equipment deviations
• Reviewing customer complaints or regulatory findings related to quantity
• Updating procedures and tolerances based on performance and risk assessments
Evidence to Maintain:
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• Quantity control trend and analysis reports
• Management review minutes with improvement actions
• Revised SOPs and work instructions
- • Trending overfills, underfills, and equipment deviations • Reviewing customer complaints or regulatory findings related to quantity • Updating procedures and tolerances based on performance and risk assessments
- • Quantity control trend and analysis reports • Management review minutes with improvement actions • Revised SOPs and work instructions
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No documented quantity control process | Develop and implement a Quantity Control SOP with targets and tolerances |
| Inaccurate weighing or dispensing equipment | Calibrate and verify equipment at defined intervals |
| Missing in-process quantity checks | Conduct and document checks throughout production runs |
| Untrained operators adjusting equipment | Provide structured training and documented authorization |