FSSC 22000: ISO/TS 22002-4 Internal Audit Checklist

The Foundation for Food Safety Certification 22000 (FSSC 22000) is a company-level certification that helps organizations ensure the supply of safe food and beverages.

The scheme uses international and independent standards such as ISO 22000, ISO 9001, ISO/TS 22003, and technical specifications for sector-specific Pre-Requisite Programs (PRPs), such as ISO/TS 22002-4.

This Process Street checklist is designed to help you successfully implement all of the measures necessary to satisfy this particular PRP program, which is essential for gaining FSSC 22000 certification if you are are a food packaging manufacturer.

The checklist will cover the following areas:

• Construction & layout of buildings
• Premises workspace
• Utilities (air, water, energy)
• Waste disposal
• Equipment, cleaning & maintenance
• Purchased materials
• Prevention of cross-contamination
• Cleaning & sanitizing
• Pest control
• Personnel hygiene
• Rework
• Product recall procedures
• Storage and transport
• Packaging information & consumer communication

It should be noted that ISO 22000 identifies areas and programs that must be considered during the development of PRPs (listed above). However, the standard leaves the responsibility for developing the details of the program to the organization; it does not give specific requirements for the pest control program, it asks you as the organization to determine what is appropriate for your organization.

Bearing in mind that not every requirement is clearly stated, it is essential for your team to be incredibly diligent during the internal audit process to put your company in the best position possible for gaining certification when a licensed third-party certifying body conducts the external audit and scheduled audits thereafter.

A little info about Process Street

Process Street is superpowered checklists. By using our software to document your processes, you are instantly creating an actionable workflow in which tasks can be assigned to team members, automated, and monitored in real-time to ensure they are being executed as intended, each and every time.

The point is to minimize human error, increase accountability, and provide employees with all of the tools and information necessary to complete their tasks as effectively as possible.

First things first, enter basic details including the company name, location, and inspection date. 

The first thing to inspect is the work environment. 

Check to verify that the location(s) of your establishments are in compliance with FSSC 22000 requirements. 

Use the form field below to summarize the construction and layout of your buildings.

You can also upload and/or link to documents that contain relevant information (e.g. floor plans).

Check the internal design and layout of your workspace.

Check to ensure that the internal structure and fittings of your building(s) are clean and in good condition. 

Check that your food processing equipment is appropriately located for compliance with FSSC 22000 requirements.

Inspect laboratory facilities to make sure they meet the requirements for FSSC 22000 certification.

Inspect any temporary/mobile premises in your workspace to make sure their condition meets FSSC 22000 certification requirements. 

Check your food storage and packaging materials to make sure they meet the requirements for FSSC 22000 certification. 

Use the form field below to summarize the layout of your workspace.

You can also upload and/or link to documents that contain relevant information (e.g. internal design photographs, details regarding packaging materials).

To begin evaluating your utilities for FSSC 22000 certification, first check your water supply.

Check that the boiler chemicals you are using are in compliance with FSSC 22000 requirements.

Check that the air quality and ventilation system throughout your work premises meet the requirements for FSSC 22000 certification.

Check that any kind of compressed air or other gases present in your facilities is stored and handled in a way that meets the requirements for FSSC 22000 certification

As a final step in the evaluation of utilities, check lighting systems throughout the premises to make sure they meet FSSC 22000 requirements. 

Use the form field below to summarize utilities throughout your workspace.

You can also upload and/or link to documents that contain relevant information (e.g. layout of ventilation systems)

Ensure that all containers used for the disposing of waste and hazardous substances are handled appropriately, as required for FSSC 22000 certification.

Check to verify that your waste management and removal system is compliant with FSSC 22000 requirements. 

Ensure that your drainage system is in good enough condition that it meets the FSSC 22000 requirements

Use the form field below to summarize your waste disposal system.

You can also upload and/or link to documents that contain relevant information.

Inspect product contact surfaces to make sure they are compliant with FSSC 2000 requirements. 

Ensure that temperature control and monitoring equipment meets the requirements for FSSC

Ensure that your cleaning plans, all utensils and equipment are in good condition and meet FSSC 22000 requirements.

Check your preventive and corrective maintenance measures to make sure they are in compliance with FSSC 22000 requirements

Use the form field below to summarize your equipment suitability, cleaning and maintenance.

You can also upload and/or link to documents that contain relevant information.

Evaluate how you go about selecting and managing your suppliers to make sure that you are meeting the requirements for FSSC 22000 certification. 

Evaluate how you handle incoming materials. 

Use the form field below to summarize how you manage purchased materials.

You can also upload and/or link to documents that contain relevant information.

Evaluate your process for managing microbiological cross-contamination that may take place during food processing. 

The best way to prevent the spread of viruses to food is to ensure that hands are washed and that they are clean and protected when handling food. Anytime a human hand touches something, there is a risk of contamination with harmful microorganisms or chemicals.

Evaluate your allergen management process to ensure it meets the requirements for FSSC 22000 certification

Allergen (as defined by FSSC): A substance (usually a protein) capable of causing a response (allergic reaction) mediated by the immune system (GFSI BRv7:2017).

Use the form field below to summarize what measures you take to prevent cross contamination.

You can also upload and/or link to documents that contain relevant information.

Inspect all cleaning and sanitizing agents and tools to ensure they are in compliance with FSSC 22000 regulations. 

Evaluate your CIP systems to ensure they are compliant with FSSC 22000 requirements.

Underperforming cleaning routines are a known root cause of food safety incidents and when an estimated 75% of cleanings executed on a daily base in the food industry are not properly validated and poorly documented (EHEDG, 2016), many contaminated products could be entering the marketplace. - Diversey

In addition to frequent verification such as visual checks or swab tests, cleaning in place (CIP) systems and protocols should be routinely validated to operate with confidence in cleaning processes and demonstrate legal compliance.

Inspect and evaluate what measures are in place to monitor sanitation effectiveness. 

Use the form field below to summarize what measures you take to ensure proper cleaning and sanitization.

You can also upload and/or link to documents that contain relevant information.

Evaluate your pest control program to ensure it meets the requirements for FSSC 22000 certification. 

This means that a formal, define program must be documented and implemented. 

Such programs should also guarantee that: 

• Contracted pest control services or organizations have appropriately trained staff
• Procedures are applied so as to prevent potential contamination of products
• Results of inspections are analyzed to identify trends

In FSSC 22000, the importance of establishing hygiene, cleaning, and incoming materials inspection procedures to avoid creating an environment conducive to pest activity is emphasized.

FSSC 22000 mentions that potential pest access points shall be sealed and openings must be designed to minimize entry of pests. 

Check all of the acess points in your facility and ensure that access prevention systems have been put in place.

It is obviously incredibly important to not have any harbourage or infestations within your food processing facility.

Conduct a thorough inspection of the work premises to make sure there are no infestations.

Evaluate the monitoring and detection systems you have in place for pest control and ensure they meet the standards required for FSSC 22000 certification.

Use the form field below to summarize what measures you take for pest control.

You can also upload and/or link to documents that contain relevant information.

Ensure that hygiene facilities and toilets are kept clean and in good working order. 

There should always be full soap dispensers present and a documented schedule for cleaning. 

Inspect all staff canteens and eating areas to ensure they meet the requirements for FSSC 22000 certification. 

Its critical to make sure that all staff working inside the food processing facility are donning the appropriate workwear and protective clothing. 

In general, maintaining good personal hygiene is essential. 

Here are 9 important tips for establishing a good personal hygiene policy:

1. Thoroughly wash and dry your hands before handling food, and wash and dry them again frequently during work.
2. Dry your hands with clean towels, disposable paper towels, or under an air dryer.
3. Never smoke, chew gum, spit, change a baby’s nappy or eat in a food handling or food storage area.
4. Never cough or sneeze over food or where food is prepared or stored.
5. Wear clean protective clothing, such as an apron.
6. Keep your spare clothes and other personal items away from where food is stored and prepared.
7. If you have long hair, tie it back or cover it.
8. Keep your nails short so they are easy to clean and don’t wear nail polish as it can chip into the food.
9. Avoid wearing jewelry, or only wear plain banded rings and sleeper earrings.

Use the form field below to summarize what measures you take to maintain personal hygiene and employee facilities.

You can also upload and/or link to documents that contain relevant information.

Evaluate storage, defect identification, and traceability methods to ensure they meet the standards of FSSC 22000. 

When handling rework in your facility, note the following:

1. Apply tags with product identification information, which may include the name of the product, lot code, and date of production. You can also use color-coded containers to identify rework material.   
2. Store rework in a way that prevents contamination with potential food hazards and growth of micro-organisms
3. Store rework in an appropriate environment that prevents or minimizes food spoilage. For example, meat rework must be stored in a temperature-controlled environment at four degrees Celsius or less to prevent or limit the growth of microorganisms.

Follow general good storage practices. For example:  

• Store rework materials off the floor and away from walls to minimize contamination
• Cover and protect rework materials
• Use clean containers
• Ensure storage room is adequate for storing food products (ex: avoid pest access, permit maintenance and cleaning)  

Proper rework usage is incredibly important for maintaining a clean work environment in which the risk of contamination is low. 

Examples of reworking may include:

• Re-forming meat patties rejected for being broken, underweight or improperly breaded  
• Reprocessing dough leftover from the previous production  
• Repacking cookies that were mislabeled  
• Re-cleaning grains that did not meet specifications  
• Reprocessing cooked sausage as pizza topping or sausage crumble
• Re-baking bread crumbs that will be used to coat other food products, such as breaded foods  
• Incorporating sausage end trimmings from one batch into the production of a new batch  
• Mixing production from one day into a batch from a different day

What is the risk of mishandling rework?

Mishandling rework material may result in potential hazards such as:

• Presence of undeclared allergens due to cross-contamination —  for example when a product containing a specific allergen is mixed with a product that does not contain the ingredient and labelling is not changed to acknowledge the fact.
• Contamination with pathogenic bacteria due to improper personal hygiene or product handling practices
• Growth of pathogenic bacteria due to temperature abuse
• Presence of undeclared restricted ingredients in the final product — for example, addition of cured meat to a fresh meat product, which should not contain curing agents

Use the form field below to summarize what measures you take to properly manage rework.

You can also upload and/or link to documents that contain relevant information.

Evaluate your product recall procedure to ensure it meets the requirements outlined in FSSC 22000 documents. 

Below is a pdf that contains useful information on how to conduct the procedure in a timely and professional manner, although it is not written specifically for those seeking FSSC 22000 certification. 

If you have any reason to suspect that food could pose a hazard to consumers,
you must recall it. This is regardless of how the concern comes to your attention.

Use the form field below to summarize your product recall procedures.

You can also upload and/or link to documents that contain relevant information.

Inspect and make sure that all vehicles and containers meet the requirements laid out by FSSC 22000. 

Below is the official FSSC 22000 brochure for information on Transport & Storage certification.

Use the form field below to summarize your warehousing.

You can also upload and/or link to documents that contain relevant information.

In the form field below, provide a summary of how you communicate with consumers and share information regarding your products through packaging.

Presented below is a summary of each area you have evaluated over the course of this checklist. 

Now is the time to review the audit, verify the information, and make an overall comment on how it went and where the organization stands in terms of achieving FSSC 22000 certification.

Also,take the time to identify and document action items moving forward. 

Establishment:

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Layout and workspace:

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Utilities:

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Waste:

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Equipment, cleaning & maintenance:

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Purchased materials & services:

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Prevention of contamination:

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Cleaning & sanitizing:

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Pest control:

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Personnel hygiene:

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Rework:

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Product recall procedures:

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Storage and transport:

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Food packaging & consumer communication:

• Safety Culture - ISO 22000 Audit 
• ISO - ISO/TS 22002-4:2013

• GFSI Compliance Checklist
• HACCP Compliance Checklist
• ISO 22000 Audit Preparation Checklist
• FSSC 22000: ISO/TS 22002-1 Internal Audit Checklist
• FSSC 22000: ISO/TS 22002-3 Internal Audit Checklist