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Run: FSSC 22000 Packaging PRP Verification Checklist

Use this checklist to verify packaging PRPs, records, and site controls under FSSC 22000 and ISO/TS 22002-4 before an audit. It helps you catch contamination...

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Program Scope and Document Control

Confirm the documented prerequisite program scope covers all packaging lines, warehouses, rework areas, and support functions included in the FSSC 22000 system.
Verify procedures, work instructions, and forms are current, approved, and removed from uncontrolled use when obsolete.
Check that records are legible, signed or electronically approved where required, and retained for the defined period.
Verify changes affecting hygiene, contamination risk, utilities, equipment, or storage were reviewed and approved before implementation.
Confirm the verification plan covers all relevant PRPs at a defined frequency and overdue actions are tracked to closure.

Facility Layout, Zoning, and Contamination Control

Verify physical or procedural segregation prevents mix-up, cross-contamination, and unauthorized movement between zones.
Check that people, materials, waste, and equipment move in a controlled manner without backtracking through protected areas.
Verify barriers, covers, or process controls protect exposed materials during handling, staging, and transfer.
Inspect floors, ledges, equipment bases, and storage areas for buildup that could attract pests or contaminate product-contact materials.
Confirm rejected, hold, or quarantined materials are labeled and physically separated to prevent unintended use.

Personnel Hygiene and GMP Controls

Check that hygiene expectations are visible and employees follow required handwashing, glove, and sanitizing practices.
Verify hair restraints, smocks, gloves, beard covers, and other PPE are suitable for the area and maintained in sanitary condition.
Confirm GMP rules address jewelry, eating, drinking, gum, tobacco, and personal items in production and storage areas.
Verify employees assigned to packaging, sanitation, maintenance, and warehouse tasks have current documented training.
Check that employee health reporting expectations are available and supervisors know when to restrict or exclude personnel.

Cleaning, Sanitation, and Chemical Control

Verify cleaning frequencies, responsible persons, and completion records are available for all relevant areas and equipment.
Check that sanitation verification results are recorded and any failures are investigated before release of the area or line.
Confirm chemicals are identified, segregated from packaging materials, and used according to approved instructions and SDS requirements.
Verify secondary containers are labeled with contents and hazard information where required.
Review records for documented follow-up, re-cleaning, and supervisor review when sanitation tasks are incomplete or ineffective.

Pest Control, Utilities, and Maintenance

Check that traps, bait stations, and monitoring devices are identified on a current site map and records are current.
Inspect for droppings, gnaw marks, nesting material, insects, or other indicators of infestation.
Verify utility points used near exposed packaging are maintained to prevent contamination and are monitored where applicable.
Check maintenance records for overdue work, lubricant control, loose parts, and post-maintenance cleaning or release checks.
Confirm temporary fixes are documented, time-limited, and do not expose product or packaging to contamination or foreign material.

Traceability, Storage, and Audit Readiness

Confirm pallets, racks, and coverings protect materials from moisture, contamination, crushing, and mix-up.
Verify incoming lots, internal transfers, and finished packaging records support one-step-forward and one-step-back traceability expectations.
Check that inventory rotation prevents use of expired, obsolete, or aged packaging materials.
Review records for scales, thermometers, metal detectors, or other devices used to verify PRPs or packaging controls.
Confirm prior findings have documented root cause, correction, corrective action, and effectiveness verification where required.

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