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22000 Food Safety Management
  Systems: An overview of the
        requirements




          www.22000-Tools.com
                                1
Introduction to
ISO 22000 and FSSC 22000




        www.22000-Tools.com
                              2
Who is ISO?

• The International Organization for Standardization
  (ISO) creates many different types of standards.
  – ISO is made up of Standards Institutes from 154 different
    countries.
  – Member countries work together to develop and approve
    standards.




                        www.22000-Tools.com                 3
What is ISO 22000?

• It is a Food Safety Management System (FSMS)
  that uses a management system approach and
  HACCP requirements.

• The goal is to provide one internationally
  recognized standard for a food safety management
  system that can be applied to any organization in
  the food chain.



                     www.22000-Tools.com              4
What is FSSC 22000?

• FSSC 22000 is a Food Safety Certification that
  uses ISO 22000 and PAS 220

     • PAS 220 gives the requirements for Prerequisite Programs for
       food manufacturers.

     • This document was added to ISO 22000 to create a system that
       could be benchmarked by the Global Food Safety Initiative
       (GFSI)

     • Some large retailers require suppliers to have a GFSI
       benchmarked scheme.


                           www.22000-Tools.com                        5
FSSC 22000 or ISO 22000?

• If your customers want a GFSI registration scheme,
  then you will use FSSC 22000

• FSSC 22000 applies only to food manufacturers, so
  if you are not a manufacturer, you will use ISO
  22000

• Manufacturers will need to evaluate the market and
  determine which standard is most appropriate for
  them

                     www.22000-Tools.com           6
How does an organization become
      22000 registered?
• You need to decide if your goal is ISO 22000
  compliance-
  – You will implement the system and follow it, and
    use self-assesment to demonstrate conformity
• If your goal is ISO 22000 Registration
  – You will implement the ISO 22000 system in your
    organization,
• If your goal is FSSC 22000 Registration
  – You will implement the ISO 22000 system, and the
    PAS 220 prerequisite programs

                    www.22000-Tools.com                7
Implementation Techniques




         www.22000-Tools.com
                               8
Implementation of ISO 22000 or FSSC 22000

• You will need to develop an implementation plan that
  covers:

   – Education on the contents of the standard
   – A comparison of your current system to the requirements of ISO
     22000, often called a gap analysis
   – A comparison of your current prerequisite programs against the
     requirements of PAS 220 (for FSSC 22000)
   – A timeline of the implementation steps based on the gap analysis
   – Time to run the Food Safety Management System, collect records
     and make improvements before your registration audit.




                                                                        9
Implementation Steps

• Assign a Food Safety Management Team
  – This team will be active in the design and development of the FSMS
    and participate in the continued management of the system.

• Assign a Management Team (22000 Steering Team)
  – This team will also be active in both the design and development and
    the ongoing management of the system.




                            www.22000-Tools.com                       10
Implementation Steps:

• The Management Team will act as a steering team
  for the project, assigning responsibilities, providing
  resources and coordinating the project.
   – The Management Team can assign task teams to work
     on specific processes that must be designed and
     documented for the FSMS.




                       www.22000-Tools.com               11
Implementation Steps:

• Each task team will evaluate the current process
  that they are assigned to and the requirements of
  the standard.
  – A new or modified process will be developed,
    documented and submitted to the Management Team for
    review and approval.




                     www.22000-Tools.com              12
Implementation Steps

• After the task teams have designed and
  documented a new or modified process, it must be
  implemented. Train all employees that are involved
  in the process

• When the required processes have been
  implemented, start your internal audit program and
  management review meetings.



                     www.22000-Tools.com           13
Implementation Steps

• Use information from internal audits and
  management review to make improvements to the
  FSMS. Run your system long enough to generate
  records for the Registrar to audit.

• Make sure all employees are trained on your 22000
  FSMS
• Have a Registrar conduct your Registration Audit.



                    www.22000-Tools.com           14
Overview of Requirements

 ISO 22000 and FSSC 22000




         www.22000-Tools.com
                               15
Overview of Requirements:
General

• The organization must develop an
  effective system that meets the
  requirements of the Standard, document,
  implement and maintain the system.

• The system must be evaluated and
  updated to stay current.




           www.22000-Tools.com          16
Overview of Requirements:
Management
• Management must be involved in and committed to the
  FSMS. They will write the Food Safety Policy and be
  responsible for making sure it is communicated and
  implemented.
• Top Management must be involved in the design and
  implementation of the FSMS. Many specific responsibilities
  are assigned to Top Management to ensure their input and
  participation.
• After implementation Management will conduct
  management review to ensure continued effectiveness of
  the system.



                         www.22000-Tools.com                   17
Overview of Requirements:
Resources
• The FSMS must clarify what resources, human and
  physical are required to create safe product.

• During development of the system you will
  determine how to ensure competent personnel,
  identify training that is required, and identify the
  infrastructure and work environment required




                       www.22000-Tools.com               18
Overview of Requirements:
Making your product
• Your organization will need to plan all of the
  processes that go into making your product to
  ensure safe product.

• Prerequisite programs will be established,
  implemented and evaluated on an ongoing basis. If
  you are looking for FSSC 22000 Certification, your
  prerequisite programs must meet the requirements
  of PAS 220.


                      www.22000-Tools.com          19
Overview of Requirements:
Making your product
• Establish and document a system for:

  –   Collecting preliminary information for hazard analysis
  –   Conducting hazard analysis
  –   Establishing the HACCP Plan
  –   Conducting verification activities
  –   Tracing product, materials and distribution




                          www.22000-Tools.com                  20
Overview of Requirements:
Nonconforming Product
• Establish and document a system for controlling all
  nonconforming product

  – When a Critical Control point is exceeded potentially
    unsafe product must be identified, assessed, controlled
    and dispositioned appropriately. An established
    withdrawal process is necessary so quick action can be
    taken if needed.
  – Identify corrections and corrective actions to be taken to
    eliminate the nonconformity and the cause of
    nonconformity.



                         www.22000-Tools.com                     21
Overview of Requirements:
Validation
• Establish and document a process to validate
  control measures before they are implemented.
  Plan for revalidation when changes are made.

• Ensure that all measuring and monitoring devices
  and methods are capable of providing the accuracy
  needed.




                    www.22000-Tools.com           22
Overview of Requirements:
Verification
• Establish and document an internal audit process.
  Train auditors, and plan internal audits to establish
  an audit program that will determine if the FSMS is
  effective and up to date.

• Implement a process for the Food Safety Team to
  evaluate and analyze verification results and take
  any necessary actions.



                      www.22000-Tools.com              23
Overview of Requirements:
Improvement
• Continually improve the FSMS through the use of:

  –   Management review
  –   Internal audits
  –   Corrective actions
  –   Verification results
  –   Validation results

• Update the FSMS


                         www.22000-Tools.com         24
22000 Templates and Tools




         www.22000-Tools.com
                               25
www.22000-Tools.com

• 22000 Food Safety Management Systems

  – Start your project with our professionally designed
    documentation.
  – Our 22000 FSMS Document package provides you with
    Microsoft Word and Excel documents to use as a
    foundation for your FSMS.
  – Customize these procedures, forms and Food Safety
    Manual to save time and ensure an efficient, effective
    system.



                       www.22000-Tools.com                   26
Step by Step Workbook and Presentations

22000 Workbook and Presentation Package
• Detailed checklists, exercises and training
  presentations to help you lead your team through
  the implementation process

• Five sections, each with a training presentation
  guide you through:
     •   The Project Plan
     •   Introduction to ISO 22000
     •   GMP-CODEX-HACCP
     •   Your HACCP Plan
     •   ISO 22000 Registration

                             www.22000-Tools.com     27
ISO 22000 Computer-based Training

• “Understanding ISO 22000 Food Safety
  Management Systems”
     • A computer based training program that your team or employees
       can work through on their own to learn the requirements of
       ISO 22000.
     • A training certificate is provided after the participant passes the
       final test.
     • Use this training to train your management team, those involved
       in the implementation and all of your employees.
     • This training can be customized with your company name, logo
       and food safety policy as well as other customizing you request.




                            www.22000-Tools.com                          28
Get all our Tools in a Value Package:

• ISO 22000 Complete Package
     •   Introduction to ISO 22000: Computer Training
     •   Step by Step Workbook and Presentation Package
     •   Gap Analysis/Internal Audit Checklist
     •   ISO 22000 PowerPoint Presentation with speaker notes
     •   ISO 22000 Documentation Package
              » Procedures
              » Forms
              » Food Safety Manual
     • ISO 22000 Internal Auditor Training CD




                            www.22000-Tools.com                 29
Internal Auditor Training on CD

• This computerized training program will prepare
  your internal audit team to conduct internal audits
  of your Food Safety Management System
     • The training include 4 sections:
             »   Requirements of ISO 22000
             »   Principles of HACCP
             »   Prerequisite Programs
             »   Internal Auditing

     • The Internal Audit section will teach audit techniques and
       procedures and coach the participant through a practice audit at
       your facility.
     • The training includes audit forms as well as procedures and
       checklists for the practice audit.

                             www.22000-Tools.com                      30
For more information visit us at:
       www.22000-Tools.com
          952-250-7172




            www.22000-Tools.com
                                    32

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Introduction To Iso22000

  • 1. 22000 Food Safety Management Systems: An overview of the requirements www.22000-Tools.com 1
  • 2. Introduction to ISO 22000 and FSSC 22000 www.22000-Tools.com 2
  • 3. Who is ISO? • The International Organization for Standardization (ISO) creates many different types of standards. – ISO is made up of Standards Institutes from 154 different countries. – Member countries work together to develop and approve standards. www.22000-Tools.com 3
  • 4. What is ISO 22000? • It is a Food Safety Management System (FSMS) that uses a management system approach and HACCP requirements. • The goal is to provide one internationally recognized standard for a food safety management system that can be applied to any organization in the food chain. www.22000-Tools.com 4
  • 5. What is FSSC 22000? • FSSC 22000 is a Food Safety Certification that uses ISO 22000 and PAS 220 • PAS 220 gives the requirements for Prerequisite Programs for food manufacturers. • This document was added to ISO 22000 to create a system that could be benchmarked by the Global Food Safety Initiative (GFSI) • Some large retailers require suppliers to have a GFSI benchmarked scheme. www.22000-Tools.com 5
  • 6. FSSC 22000 or ISO 22000? • If your customers want a GFSI registration scheme, then you will use FSSC 22000 • FSSC 22000 applies only to food manufacturers, so if you are not a manufacturer, you will use ISO 22000 • Manufacturers will need to evaluate the market and determine which standard is most appropriate for them www.22000-Tools.com 6
  • 7. How does an organization become 22000 registered? • You need to decide if your goal is ISO 22000 compliance- – You will implement the system and follow it, and use self-assesment to demonstrate conformity • If your goal is ISO 22000 Registration – You will implement the ISO 22000 system in your organization, • If your goal is FSSC 22000 Registration – You will implement the ISO 22000 system, and the PAS 220 prerequisite programs www.22000-Tools.com 7
  • 8. Implementation Techniques www.22000-Tools.com 8
  • 9. Implementation of ISO 22000 or FSSC 22000 • You will need to develop an implementation plan that covers: – Education on the contents of the standard – A comparison of your current system to the requirements of ISO 22000, often called a gap analysis – A comparison of your current prerequisite programs against the requirements of PAS 220 (for FSSC 22000) – A timeline of the implementation steps based on the gap analysis – Time to run the Food Safety Management System, collect records and make improvements before your registration audit. 9
  • 10. Implementation Steps • Assign a Food Safety Management Team – This team will be active in the design and development of the FSMS and participate in the continued management of the system. • Assign a Management Team (22000 Steering Team) – This team will also be active in both the design and development and the ongoing management of the system. www.22000-Tools.com 10
  • 11. Implementation Steps: • The Management Team will act as a steering team for the project, assigning responsibilities, providing resources and coordinating the project. – The Management Team can assign task teams to work on specific processes that must be designed and documented for the FSMS. www.22000-Tools.com 11
  • 12. Implementation Steps: • Each task team will evaluate the current process that they are assigned to and the requirements of the standard. – A new or modified process will be developed, documented and submitted to the Management Team for review and approval. www.22000-Tools.com 12
  • 13. Implementation Steps • After the task teams have designed and documented a new or modified process, it must be implemented. Train all employees that are involved in the process • When the required processes have been implemented, start your internal audit program and management review meetings. www.22000-Tools.com 13
  • 14. Implementation Steps • Use information from internal audits and management review to make improvements to the FSMS. Run your system long enough to generate records for the Registrar to audit. • Make sure all employees are trained on your 22000 FSMS • Have a Registrar conduct your Registration Audit. www.22000-Tools.com 14
  • 15. Overview of Requirements ISO 22000 and FSSC 22000 www.22000-Tools.com 15
  • 16. Overview of Requirements: General • The organization must develop an effective system that meets the requirements of the Standard, document, implement and maintain the system. • The system must be evaluated and updated to stay current. www.22000-Tools.com 16
  • 17. Overview of Requirements: Management • Management must be involved in and committed to the FSMS. They will write the Food Safety Policy and be responsible for making sure it is communicated and implemented. • Top Management must be involved in the design and implementation of the FSMS. Many specific responsibilities are assigned to Top Management to ensure their input and participation. • After implementation Management will conduct management review to ensure continued effectiveness of the system. www.22000-Tools.com 17
  • 18. Overview of Requirements: Resources • The FSMS must clarify what resources, human and physical are required to create safe product. • During development of the system you will determine how to ensure competent personnel, identify training that is required, and identify the infrastructure and work environment required www.22000-Tools.com 18
  • 19. Overview of Requirements: Making your product • Your organization will need to plan all of the processes that go into making your product to ensure safe product. • Prerequisite programs will be established, implemented and evaluated on an ongoing basis. If you are looking for FSSC 22000 Certification, your prerequisite programs must meet the requirements of PAS 220. www.22000-Tools.com 19
  • 20. Overview of Requirements: Making your product • Establish and document a system for: – Collecting preliminary information for hazard analysis – Conducting hazard analysis – Establishing the HACCP Plan – Conducting verification activities – Tracing product, materials and distribution www.22000-Tools.com 20
  • 21. Overview of Requirements: Nonconforming Product • Establish and document a system for controlling all nonconforming product – When a Critical Control point is exceeded potentially unsafe product must be identified, assessed, controlled and dispositioned appropriately. An established withdrawal process is necessary so quick action can be taken if needed. – Identify corrections and corrective actions to be taken to eliminate the nonconformity and the cause of nonconformity. www.22000-Tools.com 21
  • 22. Overview of Requirements: Validation • Establish and document a process to validate control measures before they are implemented. Plan for revalidation when changes are made. • Ensure that all measuring and monitoring devices and methods are capable of providing the accuracy needed. www.22000-Tools.com 22
  • 23. Overview of Requirements: Verification • Establish and document an internal audit process. Train auditors, and plan internal audits to establish an audit program that will determine if the FSMS is effective and up to date. • Implement a process for the Food Safety Team to evaluate and analyze verification results and take any necessary actions. www.22000-Tools.com 23
  • 24. Overview of Requirements: Improvement • Continually improve the FSMS through the use of: – Management review – Internal audits – Corrective actions – Verification results – Validation results • Update the FSMS www.22000-Tools.com 24
  • 25. 22000 Templates and Tools www.22000-Tools.com 25
  • 26. www.22000-Tools.com • 22000 Food Safety Management Systems – Start your project with our professionally designed documentation. – Our 22000 FSMS Document package provides you with Microsoft Word and Excel documents to use as a foundation for your FSMS. – Customize these procedures, forms and Food Safety Manual to save time and ensure an efficient, effective system. www.22000-Tools.com 26
  • 27. Step by Step Workbook and Presentations 22000 Workbook and Presentation Package • Detailed checklists, exercises and training presentations to help you lead your team through the implementation process • Five sections, each with a training presentation guide you through: • The Project Plan • Introduction to ISO 22000 • GMP-CODEX-HACCP • Your HACCP Plan • ISO 22000 Registration www.22000-Tools.com 27
  • 28. ISO 22000 Computer-based Training • “Understanding ISO 22000 Food Safety Management Systems” • A computer based training program that your team or employees can work through on their own to learn the requirements of ISO 22000. • A training certificate is provided after the participant passes the final test. • Use this training to train your management team, those involved in the implementation and all of your employees. • This training can be customized with your company name, logo and food safety policy as well as other customizing you request. www.22000-Tools.com 28
  • 29. Get all our Tools in a Value Package: • ISO 22000 Complete Package • Introduction to ISO 22000: Computer Training • Step by Step Workbook and Presentation Package • Gap Analysis/Internal Audit Checklist • ISO 22000 PowerPoint Presentation with speaker notes • ISO 22000 Documentation Package » Procedures » Forms » Food Safety Manual • ISO 22000 Internal Auditor Training CD www.22000-Tools.com 29
  • 30. Internal Auditor Training on CD • This computerized training program will prepare your internal audit team to conduct internal audits of your Food Safety Management System • The training include 4 sections: » Requirements of ISO 22000 » Principles of HACCP » Prerequisite Programs » Internal Auditing • The Internal Audit section will teach audit techniques and procedures and coach the participant through a practice audit at your facility. • The training includes audit forms as well as procedures and checklists for the practice audit. www.22000-Tools.com 30
  • 31. For more information visit us at: www.22000-Tools.com 952-250-7172 www.22000-Tools.com 32