ISO 22000 2005 FOOD SAFETY

STANDARD TRANSLATED INTO PLAIN ENGLISH

4. Food Safety System Requirements

4.1
Establish a food
safety management
system (FSMS)

• Develop an effective food safety management system.

• Document your food safety management system.

• Implement your food safety management system.

• Maintain your food safety management system.

• Evaluate your food safety management system.

• Update your food safety management system.

4.2
Document your food
safety management
system (FSMS)

• 4.2.1 Develop your food safety management documents.

  • Develop a food safety policy document.

  • Develop the procedures required by this standard.

  • Develop the records required by this standard.

• 4.2.2 Control your food safety management documents.

  • Develop a procedure to control your FSMS documents.

  • Document your FSMS document control procedure.

• 4.2.3 Control your food safety records.

  • Establish a set of records for your FSMS.

  • Develop a procedure to control your FSMS records.

  • Document your FSMS record control procedure.

5. Food Safety Management Requirements

5.1
Demonstrate a
commitment to
food safety

• Make sure that your organization's top managers demonstrate
  a commitment to their food safety management system (FSMS).

• Make sure that top managers support the establishment of a FSMS.

• Make sure that top managers can prove that they support their FSMS.

5.2
Establish your
food safety policy

• Make sure that your top managers establish a food safety policy.

• Make sure that your top managers communicate their
  support for your organization's food safety policy.

• Make sure that your top managers ensure that your food safety policy is implemented throughout your organization.

5.3
Plan your
food safety
management
system (FSMS)

• Make sure that top managers plan the development of your FSMS.

• Make sure that top managers plan the documentation of your FSMS.

• Make sure that top managers plan the implementation of your FSMS.

• Make sure that top managers plan the maintenance of your FSMS.

• Make sure that top managers plan the evaluation of your FSMS.

• Make sure that top managers plan the modification of your FSMS.

5.4
Clarify your FSMS
responsibilities
and authorities

• Make sure that your top managers define your
  organization's FSMS responsibilities and authorities.

• Make sure that your top managers communicate
  about FSMS responsibilities and authorities.

• Make sure that all personnel are responsible for
  reporting your organization's FSMS problems.

• Make sure that designated personnel are given the
  responsibility and authority  to solve FSMS problems.

5.5
Appoint a food
safety team leader

• Give your team leader the job of managing your FSMS.

• Give your team leader the authority to establish your FSMS.

• Give your team leader the responsibility to report on your FSMS.

5.6
Establish your
communications

• 5.6.1 Establish external communication arrangements.

  • Allocate the responsibility and authority to
    communicate externally about food safety.

  • Establish effective external communication
    arrangements to address food safety issues.

  • Implement effective external communication
    arrangements to address food safety issues.

  • Maintain effective external communication
    arrangements to address food safety issues.

• 5.6.2 Establish internal communication arrangements.

  • Establish effective internal communication arrangements.

  • Implement effective internal communication arrangements.

  • Maintain effective internal communication arrangements.

5.7
Develop emergency
response procedures

• Establish procedures to manage food safety emergencies and accidents.

• Implement procedures to manage food safety emergencies and accidents.

• Maintain procedures to manage food safety emergencies and accidents.

5.8
Carry out FSMS
management
reviews

• 5.8.1 Review your organization's food safety management system.

  • Carry out regular food safety management system reviews.

  • Keep a record of your food safety management reviews.

• 5.8.2 Examine management review inputs.

  • Review information (inputs) about your FSMS.

  • Ensure that review inputs allow top managers to see
    whether stated FSMS objectives are being achieved.

• 5.8.3 Generate management review outputs.

  • Generate decisions and actions (outputs) that assure the
    safety of the food products that fall within your FSMS.

  • Generate decisions and actions (outputs) to improve
    the effectiveness of your organization’s FSMS.

  • Generate decisions and actions (outputs) to
    update your organization’s food safety policy.

  • Generate decisions and actions (outputs) to
    revise your organization’s food safety objectives.

  • Generate decisions and actions (outputs)
    to address FSMS resource needs.

6. Food Safety Resource Requirements

6.1
Provide adequate
FSMS resources

• Provide resources needed to establish your organization's FSMS.

• Provide resources needed to implement your organization's FSMS.

• Provide resources needed to maintain your organization's FSMS.

• Provide resources needed to update your organization's FSMS.

6.2
Provide adequate
human resources

• 6.2.1 Provide competent food safety personnel.

  • Make sure that food safety personnel are competent.

  • Maintain a record of the contracts and agreements you have
    with external food safety management system (FSMS) experts.

• 6.2.2 Provide training and awareness programs.

  • Identify the competencies that personnel
    who influence food safety must have.

  • Deliver training to ensure that personnel
    have the competencies they need.

  • Make personnel aware of how their individual
    job performance influences food safety.

  • Evaluate the effectiveness of FSMS
    training and awareness activities.

  • Maintain a record of FSMS training.

6.3
Provide adequate
infrastructure

• Establish the infrastructure needed to comply with ISO 22000.

• Maintain the infrastructure needed to comply with ISO 22000.

6.4
Provide adequate
work environment

• Establish the work environment needed to comply with ISO 22000.

• Manage the work environment needed to comply with ISO 22000.

• Maintain the work environment needed to comply with ISO 22000.

7. Food Safety Realization Requirements

7.1
Manage the
realization of
safe products

• Plan the processes needed to realize safe products.

• Develop the processes needed to realize safe products.

• Implement the processes needed to realize safe products.

• Operate the processes needed to realize safe products.

7.2
Establish your
prerequisite
programs (PRPs)

• 7.2.1 Implement prerequisite programs (PRPs).

  • Establish PRPs for your organization.

  • Implement your organization's PRPs.

  • Maintain your organization's PRPS.

• 7.2.2 Make sure that your PRPs are suitable.

  • Make sure that your PRPs meet your
    organization’s unique food safety needs.

  • Make sure that your PRPs reflect and respect the
    nature of your organization and how it operates.

  • Make sure that your PRPs meet legal requirements.

  • Make sure that your food safety team formally
    approves your PRPs before they are implemented.

• 7.2.3 Make sure that your PRPs are effective.

  • Consider appropriate information from external sources
    and use it to establish your organization’s PRPs.

  • Consider your organization’s circumstances and
    structure as you establish your particular PRPs.

  • Consider your organization’s service providers and
    suppliers as you establish your particular PRPs.

  • Consider how you’re going to ensure that your
    organization’s PRPs are implemented and effective.

7.3
Get ready to do
a hazard analysis

• 7.3.1 Gather preliminary information.

  • Collect the information you will need in
    order to conduct your hazard analysis.

  • Document all relevant information before
    you carry out your hazard analysis.

• 7.3.2 Appoint a food safety team.

  • Appoint a multidisciplinary food safety team to
    develop and implement your organization’s FSMS.

  • Maintain records that show that your food safety
    team has the necessary knowledge and experience.

• 7.3.3 Describe product characteristics.

  • 7.3.3.1 Describe ingredients and materials.

  • 7.3.3.2 Describe end product characteristics.

• 7.3.4 Document the intended use of end products.

  • Describe the intended use of your end
    products and document these descriptions.

  • Describe how you expect your end products to
    be handled under reasonable circumstances.

  • Identify user groups for each end product.

  • Make sure that your intended use
    documents are kept up to date.

  • Use your intended use documents
    to prepare for your hazard analysis.

• 7.3.5 Prepare flow diagrams and describe controls.

  • 7.3.5.1 Prepare flow diagrams for your products.

  • 7.3.5.2 Describe existing controls and procedures.

7.4
Perform your
organization's
hazard analysis

• 7.4.1 Assess your food safety hazards and controls.

  • Make sure that your organization’s food
    safety team carries out a hazard analysis.

  • Make sure that your food safety team selects the
    measures that should be used to control hazards.

• 7.4.2 Identify hazards and define acceptable levels.

  • 7.4.2.1 Identify your food safety hazards.

  • 7.4.2.2 Consider your hazard environment.

  • 7.4.2.3 Specify acceptable hazard levels.

• 7.4.3 Assess your organization's food safety hazards.

  • Carry out a hazard assessment for each one
    of your organization’s food safety hazards.

  • Describe your hazard assessment methodology.

  • Record results of your food safety hazard assessment.

• 7.4.4 Select measures to control your hazards.

  • Use your hazard assessment to select control measures that are
    capable of controlling your organization’s food safety hazards.

  • Review your existing food safety control measures.

  • Study each control measure and decide whether you should
    use your operational PRPs or your HACCP plan to manage
    it (categorize each control measure).

  • Implement your food safety control measures.

  • Document the methodology and the parameters that were
    used to categorize your food safety control measures.

  • Record the results of your categorization decisions.

7.5
Establish your
operational
prerequisite
programs
(OPRPs)

• Indicate which hazards will be controlled by each OPRP.

• Identify the control measures that will be used by each OPRP.

• Define the procedures that will be used to monitor your OPRPs.

• Clarify corrections and corrective actions for your OPRPs.

7.6
Establish your
HACCP plan

• 7.6.1 Document your organization's HACCP plan.

  • Establish an HACCP plan to control your
    organization’s food safety hazards.

• 7.6.2 Identify your critical control points (CCPs).

  • Identify CCPs for each of the control measures
    that will be used by your HACCP plan to manage
    and control food safety hazards.

• 7.6.3 Specify critical limits for each critical control point (CCP).

  • Specify critical limits for each CCP in order to
    ensure that you do not exceed acceptable food
    safety hazard levels for end products.

  • Explain why you have chosen your particular
    critical limits and document your rationale.

  • Use your critical limits to ensure that you do not
    exceed acceptable food safety hazard levels.

• 7.6.4 Monitor your critical control points (CCPs).

  • Establish a monitoring system for each CCP.

  • Establish procedures and instructions to help
    you monitor your CCPs and critical limits.

  • Establish a record keeping system to
    track your CCP monitoring activities.

• 7.6.5 Respond to critical limit violations.

  • Use your HACCP plan to describe the actions you plan
    to take when you exceed or violate critical limits.

  • Establish and maintain procedures to handle
    products that are potentially unsafe.

7.7
Update preliminary
documents and
programs

• Update documents previously used for your hazard analysis.

• Update your organization's prerequisite programs (PRPs).

• Update your organization's HACCP plan (if necessary).

7.8
Plan and perform
your verification
activities

• Plan your organization's FSMS verification activities.

• Verify that your FSMS has been implemented.

• Record the results of your verification activities.

• Report verification results to your food safety team.

7.9
Establish a product
traceability system

• Make sure that your system can trace product lots.

• Make sure that your system can trace supplied materials.

• Make sure that your system can trace product distribution.

7.10
Control your
nonconforming
products

• 7.10.1 Identify and correct nonconforming products.

  • Identify and control the use and release
    of all nonconforming products.

  • Establish a procedure to manage and
    control your nonconforming end products.

  • Manage and control your product corrections.

• 7.10.2 Evaluate data and take corrective actions.

  • Evaluate data derived from the monitoring
    of food safety hazards and control measures.

  • Establish and maintain corrective action procedures.

  • Use your procedures to take corrective actions.

  • Record the corrective actions you have taken.

• 7.10.3 Manage potentially unsafe products.

  • 7.10.3.1 Control potentially unsafe products.

  • 7.10.3.2 Evaluate potentially unsafe products.

  • 7.10.3.3 Reprocess or dispose of unsafe products.

• 7.10.4 Withdraw and secure unsafe products.

  • Appoint personnel and give them the authority to
    manage the withdrawal of unsafe end product lots.

  • Establish and maintain a procedure to control
    the withdrawal of unsafe end product lots.

  • Use your procedure to withdraw unsafe product lots.

  • Secure or supervise all withdrawn end product lots.

  • Record your unsafe product withdrawal activities.

  • Report unsafe product withdrawals to top management.

  • Use appropriate techniques to verify the effectiveness
    of your organization’s product withdrawal program.

  • Record the effectiveness of your withdrawal program.

8. Food Safety Confirmation Requirements

8.1
Confirm and improve
food safety methods

• Plan how to confirm that food safety methods are working.

• Implement plans to confirm that food safety methods are working.

8.2
Validate food safety
control measures

• Validate your control measures before you implement them.

  • Make sure that your validations can confirm that
    your food safety control measures are effective.

• Revalidate your control measures whenever you change them.

8.3
Control your
monitoring and
measuring methods

• Prove that monitoring and measuring methods are adequate.

• Verify your organization's measuring methods and equipment.

• Validate your monitoring and measuring software.

8.4
Verify your food
safety management
system (FSMS)

• 8.4.1 Perform regular internal audits.

  • Establish an internal audit program.

  • Plan your internal audit projects.

  • Perform regular internal audits of your FSMS.

  • Make sure that your managers solve problems
    discovered in their areas by internal auditors.

  • Follow up on the actions taken by managers to
    solve problems discovered during internal audits.

• 8.4.2 Evaluate your verification results.

  • Make sure that your food safety team evaluates the
    specific results of previous verification activities.

  • Take action if your evaluation shows that your FSMS
    fails to comply with your planned arrangements.

• 8.4.3 Analyze your verification results.

  • Make sure that your food safety team analyses the
    specific results of previous verification activities.

  • Confirm that your FSMS meets requirements.

  • Figure out if your FSMS needs to be changed.

  • Identify potentially unsafe product trends.

  • Collect information to help you plan internal audits.

  • Collect evidence that proves that actions taken
    to address nonconformities are effective.

  • Record the results of your verification analysis
    and the activities that result from your analysis.

  • Report the results of your verification analysis
    and the activities that result from your analysis.

  • Use your analytical results and activities as input
    to help you update your organization’s FSMS.

8.5
Improve your food
safety management
system (FSMS)

• 8.5.1 Continually improve your organization's FSMS.

  • Use communication to help you continually
    improve the effectiveness of your FSMS.

  • Use management reviews to help you continually
    improve the effectiveness of your FSMS.

  • Use internal audits to help you continually
    improve the effectiveness of your FSMS.

  • Use corrective actions to help you continually
    improve the effectiveness of your FSMS.

  • Use verification studies and research to help you
    continually improve the effectiveness of your FSMS.

  • Use control measure validation results to help you
    continually improve the effectiveness of your FSMS.

• 8.5.2 Continually update your organization's FSMS.

  • Make sure that top management actively ensures
    that your organization continually updates its FSMS.

  • Make sure that your food safety team
    evaluates your FSMS at planned intervals.

  • Make sure that your food safety team studies their
    evaluation reports and then decides whether food
    safety programs and plans should be reviewed.

  • Update your organization’s FSMS.

  • Record your FSMS updating activities.

  • Report your FSMS updating activities.

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