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7. Food Safety Realization Requirements |
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7.1
Manage the
realization
of
safe products
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Plan the processes needed to realize
safe products.
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Develop the processes needed to
realize safe products.
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Implement the processes needed to
realize safe products.
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Operate the processes needed to
realize safe products.
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7.2
Establish your
prerequisite
programs (PRPs)
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7.2.1 Implement
prerequisite programs
(PRPs).
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Establish PRPs for your organization.
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Implement your organization's PRPs.
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Maintain your organization's PRPS.
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7.2.2 Make sure that your PRPs are suitable.
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Make sure that your PRPs meet your
organization’s unique food safety needs.
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Make sure that your PRPs reflect and respect
the
nature of your organization and how it operates.
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Make sure that your PRPs meet legal
requirements.
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Make sure that your food safety team formally
approves your PRPs before they are implemented.
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7.2.3 Make sure that your PRPs are effective.
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Consider appropriate information from external
sources
and use it to establish your organization’s PRPs.
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Consider your organization’s circumstances and
structure as you establish your particular PRPs.
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Consider your organization’s service providers
and
suppliers as you establish your particular PRPs.
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Consider how you’re going to ensure that your
organization’s PRPs are implemented and effective.
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7.3
Get ready to do
a hazard analysis
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7.3.1 Gather preliminary information.
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7.3.2 Appoint a food safety team.
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7.3.3 Describe product characteristics.
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7.3.4 Document the intended use of end
products.
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Describe the intended use of your end
products and document these descriptions.
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Describe how you expect your end products to
be handled under reasonable circumstances.
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Identify user groups for each end product.
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Make sure that your intended use
documents are kept up to date.
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Use your intended use documents
to prepare for your hazard analysis.
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7.3.5 Prepare flow diagrams and describe
controls.
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7.4
Perform your
organization's
hazard analysis
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7.4.1 Assess your
food safety hazards and
controls.
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7.4.2 Identify hazards and define acceptable
levels.
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7.4.2.1 Identify your food safety hazards.
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7.4.2.2 Consider your hazard environment.
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7.4.2.3 Specify acceptable hazard levels.
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7.4.3 Assess your organization's food safety
hazards.
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Carry out a hazard assessment for each one
of your organization’s food safety hazards.
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Describe your hazard assessment methodology.
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Record results of your food safety hazard
assessment.
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7.4.4 Select
measures to control
your hazards.
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Use your hazard assessment to select control
measures that are
capable of controlling your organization’s food safety
hazards.
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Review your existing food safety
control
measures.
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Study each control measure and decide whether
you should
use your operational PRPs or your HACCP plan to manage
it.
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Implement your food safety control measures.
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Document the methodology and the parameters
that were
used to categorize your food safety control measures.
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Record the results of your categorization
decisions.
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7.5
Establish your
operational
prerequisite
programs
(OPRPs)
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7.6
Establish your
HACCP plan
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7.6.1 Document your organization's
HACCP plan.
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7.6.2 Identify your
critical control points
(CCPs).
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7.6.3 Specify
critical limits for each
critical control point (CCP).
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Specify critical limits for each CCP in order
to
ensure that you do not exceed acceptable food
safety hazard levels for end products.
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Explain why you have chosen your particular
critical limits and document your rationale.
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Use your critical limits to ensure that you do
not
exceed acceptable food safety hazard levels.
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7.6.4 Monitor your
critical control points
(CCPs).
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Establish a monitoring system for each CCP.
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Establish procedures and instructions to help
you monitor your CCPs and critical limits.
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Establish a record keeping system to
track your CCP monitoring activities.
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7.6.5 Respond to
critical limit violations.
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7.7
Update preliminary
documents and
programs
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7.8
Plan and perform
your verification
activities
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Plan your organization's FSMS
verification
activities.
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Verify that your FSMS has been implemented.
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Record the results of your verification
activities.
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Report verification results to your food
safety team.
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7.9
Establish a product
traceability system
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Make sure that your system can
trace
product lots.
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Make sure that your system can trace
supplied materials.
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Make sure that your system can trace
product distribution.
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7.10
Control your
nonconforming
products
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7.10.1 Identify and correct
nonconforming
products.
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Identify and control the use and release
of all nonconforming products.
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Establish a procedure to manage and
control your nonconforming end products.
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Manage and control your product
corrections.
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7.10.2 Evaluate data and take
corrective
actions.
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Evaluate data derived from the monitoring
of food safety hazards and control measures.
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Establish and maintain corrective action
procedures.
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Use your procedures to take corrective
actions.
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Record the corrective actions you have taken.
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7.10.3 Manage potentially unsafe products.
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7.10.3.1 Control potentially unsafe products.
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7.10.3.2 Evaluate potentially unsafe products.
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7.10.3.3 Reprocess or dispose of unsafe
products.
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7.10.4 Withdraw and secure unsafe products.
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Appoint personnel and give them the authority
to
manage the withdrawal of unsafe end product lots.
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Establish and maintain a procedure to control
the withdrawal of unsafe end product lots.
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Use your procedure to withdraw unsafe product
lots.
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Secure or supervise all withdrawn end product
lots.
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Record your unsafe product withdrawal
activities.
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Report unsafe product withdrawals to top
management.
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Use appropriate techniques to verify the
effectiveness
of your organization’s product withdrawal program.
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Record the effectiveness of your withdrawal
program.
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