Understanding 22000 Food Safety Management Systems Copyright © 2011 Vinca, LLC dba 22000-Tools.com

What is ISO 22000? A set of requirements for a Food Safety Management System (FSMS) It was developed to fill the need for a worldwide Food Safety Standard Worldwide there is a trend towards 3rd party certification for food safety management systems. As the food that we manufacture and distribute becomes more global each year, the number of risks to food safety increase as well. More and more companies are requesting their suppliers to become certified.

The 22000 Standards, ISO and FSSC 22000 Many standards already exist worldwide... ISO 22000 and FSSC 22000 have global acceptance FSSC 22000 is a GFSI Benchmarked standard There have been an abundance of food safety standards in use, the problem was that they were not equivalent. It was hard to know what each certification really meant. Two improvements have taken place in recent years. 1) ISO 22000 was developed following the well tested and accepted ISO Management Systems Model, leading to worldwide acceptance of ISO 22000 registrations. 2) The “Global Food Safety Initiative”, (GFSI) has “benchmarked” standards. This is important because major retailers worldwide: Carrefour, Tesco, ICA, Metro, Migros, Ahold, Wal-Mart and Delhaize agreed to reduce duplication in the supply chain through the common acceptance of any of the GFSI benchmarked schemes. Many other food service, retail and manufacturing companies have now joined this approach. This means that many suppliers are requesting a GFSI Benchmarked scheme. If your customers want to see a GFSI recognized certification, you will need to use FSSC 22000, ISO 22000 is not recognized. This is because GFSI determine that the prerequisite programs requirements were not specific enough. To address this concern, FSSC 22000 Scheme was developed. It adds the requirements of the PAS 220 so that specific prerequisite program requirements are included in the certification. (GFSI recognized certifications include SQF Level 2, BRC, IFS and others)

What is ISO 22000? ISO 22000 Applies to all stages of the supply chain Is aligned with ISO 9001 to enhance compatibility with existing management system FSSC 22000 Applies to Food Manufacturers Contains the requirements of ISO 22000 and the ISO/TS 22002-1, or ISO/TS 22002-4. ISO/TS 22002-1contains specific requirements for prerequisite programs (PRPs). The ISO/TS 22002-4 contains PRP requirements for Food Packaging Manufacturers

What is ISO 22000? Sections 4 - 8 Contain the requirements ISO 22000 Standard Section 1: Scope Section 2: Normative Reference Section 3: Terms & Definitions Section 4: General Requirements Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning & Realization of Safe Products Section 8: Validation, Verification & Improvement Lets look at the requirements of ISO 22000. These are the management systems requirements and they will apply to both ISO 22000 certifications and FSSC 22000 certifications. The requirements are found in sections 4 through 8 of the standard. Sections 1-3 contain information, but not requirements.

4.1 General Establish an effective Food Safety Management System (FSMS) Keep it current So lets start with section 4, where the actual requirements begin. This presentation covers the highlights, to give employees or management a general idea of what is required for the management system. For a more detailed explanation of the requirements, use the online training program “Understanding 22000 Food Safety Management Systems” at www.22000-Tools.com. Section 4.1 has the overall, general requirements that your organization build an effective food safety management system and keep it current. You will do this by following the more detailed requirements in the rest of the standard.

4.2 Documentation Requirements Document your system Control your documents Like any good management system, this one must be documented, and those documents kept current and controlled. You want to make sure that everyone is able to find the correct, current information to do their job.

4.2 Records Maintain required records Control your records Records are your way of demonstrating that you have adhered to your food safety management system requirements. Your employees have worked hard to follow the approved, documented procedure and perform processes correctly. Take credit for that by keeping clear, detailed, accurate records that show the good work!

5.1 Management Commitment Management must be involved in and committed to the FSMS. Objectives support safety Everyone knows the importance of meeting the requirements Without management involvement and commitment the system will not get far. Resources must be provided, the system cannot be created without management being behind the effort. Build objectives that support the food safety policy, and create a culture where employees know that meeting requirements is expected and valued.

5.2 Food Safety Policy Management creates for Food Safety Policy Management is responsible for communicating the policy Management is responsible for ensuring that the policy is implemented Your food safety policy is your way of communicating what you want to achieve with your food safety management system. Make it a strong statement about your commitment to providing safe product. Communicate it and implement it!

5.3 FSMS Planning As top management, take an active role in planning the system Be involved in the design and implementation Make sure the integrity is maintained as changes are made Do not hand off the implementation to on department and wait to hear that you are ready for your certification audit. Be involved in the development, be on a “steering team” that monitors the progress and helps make important decisions on the design of the system.

5.4 Responsibility and Authority Define responsibilities and authority Communicate them Everyone is responsible for reporting problems with the FSMS - make sure they know that Document a clear organizational chart and job descriptions. Make responsibilities and authorities known.

5.5 Food Safety Team Leader Appointed by top management Reports to top management on the status of the FSMS Top management must appoint a food safety team leader. They will be a key individual in both the development and the on going maintenance of the system.

5.6 Communication Establish a system for external communication Establish a system for internal communication Without communication, errors and food safety hazards can occur. Put clear communication channels in place, make sure they are well defined and understood.

5.7 Emergency Preparedness Be prepared to respond to emergency situations Prepare an emergency plan to address potential situations: Fire Flood Accidents Contamination Others... Think about the emergency situations that might occur at your facility. Identify the potential situations, and plan for them.

5.8 Management Review Key step in a Management Systems approach Management meets to evaluate the performance of the FSMS You will continue to be involved in the maintenance and improvement of the Food Safety Management System. Management review is one tool you will use to evaluate and improve the performance of the system. Management review will take place at least once/year. Quarterly meetings can be very effective.

6 Resource Management Top management is responsible for providing the resources required Human resources Infrastructure Work Environment People are one of the resources you will need to provide. Your employees must be qualified and trained for the positions and responsibilities that they have. The work environment and infrastructure must be sufficient to produce safe product. If you roof is leaking, or traffic patterns are bad you have a food safety risk. Part of building your system is making sure that the facilities provide the conditions needed to create safe product. Changes may be needed, and that can mean more resources needed as part of the implementation of the system.

7 Planning & Realization of Safe Product Your organization will need to plan all of the processes that go into making your product in order to ensure a safe end product Section 7 addresses the actual production of your product, from planning to realization.

7.2 Prerequisite Program Prerequisite Programs: Basic Conditions and activities that are necessary to maintain a hygienic environment throughout the food chain The Food safety Team establishes PRPs For FSSC 22000 you will also include prerequisite programs to meet the requirements of ISO/TS 22002-1 or ISO/TS 22002-4

7.3 Preliminary Steps The Food Safety Team Identifies product characteristics Describe intended use Prepare flow diagrams Describe process steps and control measures The food safety team has specific responsibilities for the system identified throughout section 7 and 8. It is important to build an effective team. Include representatives from throughout the facility. They play a key role in planning. This section 7.3 Preliminary Steps has requirements for collecting information that will be used for hazard analysis.

7.4 Hazard Analysis The Food Safety Team Verifies the accuracy of the flow diagrams Conducts hazard analysis to identify potential food safety hazards Selects control measures to prevent or eliminate those hazards Once the information has been collected the food safety team will analyze it and identify hazards and related control measures that will be used to reduce or eliminate the hazard. All identified hazards must be eliminated or reduced to acceptable levels through the use of controls. Controls include prerequisite programs, critical control points and operational prerequisite programs. For more detailed training visit www.22000-Tools for online training “Principles of HACCP”

7.5 Establish Operational PRPs Similar to a Critical Control Point, an Operational Prerequisite Program is a control point where biological, physical, or chemical hazards identified in hazard analysis can be controlled. Your food safety team will determine if the control point is a CCP or oPRP using the decision criteria in Section 7 of the standard. The Food Safety Team establishes Operational PRPs Operational prerequisite programs are actually more similar to a critical control point than they are to a prerequisite program. You will be classifying your controls as Critical Control Points or Operational Prerequisite Programs based on the criteria in section 7.4.4 of the standard. A decision tree is a good tool to use to make the determination.

7.6 Establish the HACCP Plan The Food Safety Team Documents the HACCP plan The HACCP Plans must be documented, and verified as accurate by the food safety team.

7.7 Updating The Food Safety Team Updates any preliminary information that may have changed during or as a result of the hazard analysis Once you complete the HACCP plan, make sure none of the preliminary information has changed. If it has, update it and go through the hazard analysis with the new information. It may result in changes to your HACCP plan.

7.8 Verification Planning Identify what verification activities are required including verification of PRPs, the HACCP Plan and other procedures. Verification will include internal audits, any food safety or GMP audits, verification of cleaning records and HACCP records and other activities that you identify for your system. A good approach is to prepare a verification calendar with all of the required activities.

7.9 Traceability A traceability system ensures that the identification of product is maintained from raw material to delivery. Establish the traceability of product From supplier to distribution Identify materials, ingredients product and packaging so you can do a trace of any material or ingredient from use to delivery to customer.

7.10 Control of Nonconformity When a control limit is exceeded or a PRP is found to be out of control affected product must be controlled. Corrections Corrective actions Handling of potentially unsafe product The HACCP plan will need to include the planned actions that will be taken if there is an out of control CCP or PRP. This must include how to determine what product may have been affected, and how the product will be controlled.

8.2 Validation, & 8.3 Control of Measuring & Monitoring All measuring equipment must be capable of the required measurements and show calibration to national or international standards. Calibrate and control measuring equipment to ensure that measurements are valid All measuring equipment must be capable of the required measurements and show calibration to national or international standards.

8.4 Verification Establish and document an internal audit process The Food Safety Team evaluates and analyzes verification results The Food Safety Team takes any necessary action Internal audits are one of the verification activities that is required. You will need to train internal auditors and establish an internal audit program. The food safety team is responsible for evaluating all verification results. This means looking at the results of internal audits, food safety audits, PRP verifications, and HACCP verifications. Look for trends, effectiveness or any issues. The conclusions from or results of the analysis must be included in management review.

8.5 Improvement Continually improve the FSMS through the use of: Management review Internal audits Corrective actions Verification results Validation results You will use these systems to improve your Food Safety Management System.

8.5 Updating the FSMS Top management is responsible for seeing that the FSMS is continually updated The Food Safety Management Team evaluates the FSMS at planned intervals Once you have your system implemented, you will begin to work to keep it up to date and to improve it. Management is responsible for the effectiveness of the system. Management review meetings are a great way to stay informed on the status of the system, evaluate the system for any needed changes, actions or improvements and to drive the continual improvement of the system. As you develop your system, consider using the procedure templates developed by our professionals. They are available in the All-in-One package or in the 22000 Template Package at www.22000-Tools.com.

Further Resources Online ISO 22000 Training for your Food Safety Team Leader and your Food Safety Team is available at 22000-tools.com.