FSSC 22000 Packaging Audit Checklist: What Auditors Inspect

The first thing that comes to mind when preparing for an FSSC 22000 packaging audit is what the auditor will be looking at. An FSSC 22000 Packaging Audit Checklist is designed specifically to show food packaging manufacturers, including corrugated box manufacturers, flexible film converters, and suppliers of glass/metal containers, what to expect from the FSSC 22000 packaging audit. An FSSC 22000 packaging audit includes both the food safety management system requirements from ISO 22000 as well as the industry-specific prerequisites program ISO/TS 22002-4. This checklist will help you understand what an FSSC 22000 packaging auditor will be expecting during his/her audit.

What Is an FSSC 22000 Packaging Audit

FSSC 22000 packaging audit is a process audit performed on-site which confirms whether the food safety management system used by the packaging manufacturing company complies with the ISO 22000, ISO/TS 22002-4 and FSSC 22000 scheme requirements. This audit includes checking documentation, inspecting facilities, observing processes and interviewing personnel, and concludes with the certification decision based on nonconformities identified.

This audit targets organizations which manufacture food packaging material meant for direct or indirect contact with food products – corrugated boxes, plastic bags and films, glass jars and bottles, metal cans and closures, paperboard cartons. Unlike a general quality audit, it focuses on the ability of packaging to endanger the food safety through migration, contamination or damage during food product shelf life period.

Who Needs an FSSC 22000 Packaging Audit

Any manufacturer supplying packaging that comes into direct or indirect contact with food, or whose customers require FSSC 22000 as a purchasing condition, typically needs certification. This commonly includes:

• Manufacturers of corrugated boxes and cartons for primary/secondary food packaging
• Flexible packaging converters manufacturing pouches, films, and laminates
• Glass and metal can makers – bottles, jars, cans, and closures
• Manufacturers of plastic packaging – trays, bottles, caps, and rigid containers
• Paper & paperboard converters for food packaging cartons

FSSC 22000 Packaging Audit Checklist: What Auditors Inspect

The FSSC 22000 packaging checklist consists of ten main areas which include documentation, prerequisite programs, hazard analysis, site standards, personnel practices, traceability, product development, foreign body control, storage and dispatch, and management review. They are all evaluated on the basis of ISO 22000 clauses and ISO/TS 22002-4 prerequisite requirements.

1. Food Safety Management System Documentation

The audit begins by looking at the documentation, which includes the food safety policy, the scope statement, the food safety objectives, and the documented procedures that are needed for ISO 22000. The auditors review version control, approval, and whether the documents correspond with reality.

2. Prerequisite Programs (PRPs) Under ISO/TS 22002-4

This is the core of the audit that applies specifically to the packaging operation. The standards for the prerequisite programs include building and layout, utilities, waste management, suitability of equipment, cleaning, pest control, and employee facilities – all adapted specifically for packaging operations, rather than for food processing plants.

3. HACCP / Food Safety Hazard Analysis

Although packaging is not involved in processing of food products, FSSC 22000 mandates a hazard analysis that should consider physical, chemical, biological, and even where applicable, allergen and radiological hazards which may contaminate the food through the use of packaging. The audit looks at the composition of the hazard analysis team, hazard identification per process step, and justification for critical control points/operational PRPs through factual data.

4. Site and Facility Standards

The audit includes the condition of the building both outside and inside, proper product flow for avoidance of cross-contamination, drainage, lighting, ventilation, and segregation of the raw materials, production, and finished products areas. The auditor will physically inspect the area without depending solely on documentation.

The auditor will assess the maintenance procedures at the site; specifically whether repairs and servicing are done using the permit-to-work system which will keep away grease, metal, or fasteners from products. An effective maintenance log is usually one of the first documents the auditor will ask for.

5. Personnel Hygiene and Training

Auditors assess the procedures regarding hygiene, protective clothing policy, hand-washing facilities, procedures for visitors and contractors, and training documentation. They frequently quiz floor-level workers to verify that training has been understood rather than simply completed.

6. Material Traceability and Supplier Approval

Traceability is an audited process, not merely a stated one. Normally, during an audit, there is a simulated recall involving the selection of a batch of finished packaging and tracking it backwards by using lot numbers of raw materials, certificates of suppliers, and production records in a specified time window.

7. Product Design and Development

For packaging materials that come into direct contact with food, auditors review whether there is a process that takes into account migration testing, food contact material regulations, and raw material supplier suitability declarations. Changing the substrate, ink, adhesives, or coating materials requires such a review.

8. Foreign Body and Contaminant Control

Glass, metallics, wood and plastics contamination control programs are carefully audited, especially with regards to hard-packaging companies. The auditor would review the records for glass and brittle plastics, metal detector or X-Ray screening processes if any, and the breakage handling procedures.

9. Storage, Warehousing and Dispatch

Packaging integrity between manufacture and arrival at the customer’s site is assessed through inspection of finished goods storage environment, pest control records, stock rotation, and good practices for loading and dispatch.

10. Management Review and Internal Audits

Last but not least, an auditor is satisfied that the establishment has an internal audit program of their own and that at the management review meeting there is review on how well the performance of the food safety system is.

FSSC 22000 Packaging Audit Checklist at a Glance

Common FSSC 22000 Packaging Audit Non-Conformances

Auditors don’t expect perfection, but certain gaps come up repeatedly across packaging sites:

• Generic and incomplete hazard analyses not specific to the packaging process at the site
• Missing food contact declarations of compliance for materials supplied to the site
• Incompleteness in PRP control monitoring records, with missing frequencies
• Traceability mock recalls which surpass the target time frame set by the site
• ISO/TS 22002-4 internal audits which fail to cover all the relevant clauses during the certification period

How to Prepare for an FSSC 22000 Packaging Audit

1. Do a gap analysis to ISO 22000 and ISO/TS 22000-4 not less than 8-12 weeks prior to the audit
2. Fix any PRP monitoring gaps and ensure updated training documents
3. Perform a test recall exercise and record time taken against set targets
4. Check declarations from suppliers to determine compliance expiry or scope limitations
5. Perform an internal audit addressing all relevant clauses
6. Perform management review meeting with food safety performance in the discussion list

Most packaging suppliers employ an FSSC 22000 Certification Consultancy at this point because gap assessment and mock audit helps to identify problems before they become certification body findings.

FSSC 22000 Packaging Audit vs Other Packaging Certifications

FSSC 22000 and BRCGS Packaging are GFSI-recognized, and many exporters have both since retailers have varied systems. ISO 9001, however, does not meet the demands of food contact packaging buyers, although it is commonly used along with FSSC 22000 as the basic quality management system.

Cost and Timeline Considerations

The costs of certification and audit time depend on site size, production line counts, and the number of employees, with Stage 1 and Stage 2 audits usually spaced a few weeks apart. Budgeting for a pre-audit gap assessment, small tooling and facility adjustments, and certification body costs in advance will allow you to avoid any last-minute non-conformances that may delay the process of obtaining your certification.

If your business has an existing ISO 9001 quality management system certification or something similar, you will get through the FSSC 22000 gap assessment more quickly since you already have a system of document control and internal auditing. First-time applicants will need some extra lead time to collect adequate PRP monitoring history.

Key Takeaways

• An FSSC 22000 Packaging Audit Checklist includes documentation, PRPs, hazard analysis, site criteria, traceability, among other aspects.
• The prerequisite program specific to packaging that is reviewed along with ISO 22000 is ISO/TS 22002-4.
• Traceability is tested using a time-bound mock recall test, not just by reviewing documents.
• Some common observations include lack of hazard analysis and expired supplier declarations of conformance.
• Conducting gap assessment and mock audit 8 to 12 weeks prior to certification is essential.

Conclusion

There is nothing mysterious about an FSSC 22000 packaging audit checklist when one understands what is expected of a site during the audit – having a functional food safety management system, PRPs related to packaging in line with ISO/TS 22002-4 and demonstrating traceability and control of hazards. Sites which do a self-gap analysis and self-mock recall prior to the auditor visit find themselves having much less to correct in terms of non-conformities. Legal4sure helps packaging facilities in all phases of such preparation.