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Introduction to HACCP

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					  Introduction to HACCP

   Alling H. Yancy, DVM

Regulatory Compliance Group
          Manager
        Gold Kist Inc.
         Atlanta, GA
  HAZARD
ANALYSIS AND
  CRITICAL
  CONTROL
    POINT
   (HACCP)
             Goal
To reduce the risk of foodborne
illnesses associated with food to
the maximum extent possible
           HACCP
Framework    for food safety
 through prevention
Tested approach
Clarifies and strengthens
 industry’s responsibility for food
 safety
     Benefits of HACCP
   Addresses chemical, physical and biological,
    especially microbiological, hazards




   Helps separate industry and regulatory
    responsibilities
  Benefits of HACCP
IndustryHACCP + Regulatory
 Oversight = Safer Food

Endorsed  by a variety of
 stakeholders
          Stakeholders
 World  Health Organization/United
  Nations (Codex)
 Canada
 Australia/New Zealand
 European Union
 Fast food chains
 Customers
    Food Safety Strategy
   Defines an acceptable level of
    food safety performance

   Holds each individual plant accountable for meeting
    that level of performance

   Food safety from farm to table

   Encourages technological development
     Role of FSIS and
         Industry
 FSIS- Setting criteria for food safety
 performance

 Industry   - Testing and meeting target
 levels
    Responsibility of
       Industry
   Process control

   Producing safe and
    wholesome products
Responsibility of the
Regulatory Agencies
 Ensure that industry is meeting
 its food safety responsibilities
OBLIGATIONS OF PLANT
    MANAGEMENT

Create  an environment of purpose
 toward improving products and
 services to provide for long-term needs
 rather than short-term profitability
OBLIGATIONS OF PLANT
    MANAGEMENT

Clearly communicate a
 permanent commitment
 to product safety
OBLIGATIONS OF PLANT
    MANAGEMENT

 Focus supervision on helping people do
 a better job; ensure that immediate
 action is taken on conditions that effect
 the safety of the product
 OBLIGATIONS OF PLANT
     MANAGEMENT
 Encourage effective two-way
 communications to drive out fear and
 rumor “grapevine” throughout the
 organization
 OBLIGATIONS OF PLANT
     MANAGEMENT
 Breakdown barriers between
 departments by encouraging teamwork
 approach to problem solving
 OBLIGATIONS OF PLANT
     MANAGEMENT
Set a good example; employees tend
 to emulate their boss
OBLIGATIONS OF PLANT
    MANAGEMENT
 Askemployees for their suggestions; let
 them know they play a role in the
 decision making process
 OBLIGATIONS OF PLANT
     MANAGEMENT
 Giveemployees a sense of direction and
 goals; they need to know the why’s,
 what’s, when’s and how’s of their jobs
OBLIGATIONS OF PLANT
    MANAGEMENT

 Make  all employees feel
 like they belong and that
 they are a valued member
 of your team
BIOLOGICAL
 HAZARDS
BIOLOGICAL HAZARDS
Disease producing organisms (pathogens)
that can infect or intoxicate humans (and
animals) and cause foodborne illness
TYPES OF FOODBORNE
      DISEASE
 Foodborne   Infection – A disease that
 results from eating food containing
 harmful living pathogens
  - Salmonella
  - Listeria monocytogenes
 TYPES OF FOODBORNE
       ILLNESS
 Foodborne Intoxication – A
 pathological condition that results
 when the toxins or poisons from
 pathogens are present in ingested
 food
  – Staphylococcus enterotoxin
  – Clostridium botulinum toxin
 BACTERIA ASSOCIATED
WITH FOODBORNE ILLNESS
         Escherichia   coli O157:H7
         Salmonella

         Campylobacter  jejuni
         Clostridium perfringens

         Shigella
 BACTERIA ASSOCIATED
WITH FOODBORNE ILLNESS

Listeria
 monocytogenes
Clostridium botulinum

Staphylococcus aureus

Yersinia enterocolitica
  FACTORS AFFECTING
 GROWTH OF PATHOGENS
 Warm   temperature
 Neutral pH (pH 7)
 High water activity
 Appropriate time
 Plentiful supply of nutrients
 Free of preservatives
 Presence or absence of oxygen
Environmental Factors

The Time/Temperature Relationship
 is VERY important!!!
        CONTROL OF
    BIOLOGICAL HAZARDS

   Prevent pathogen contamination
    - Good personnel hygiene

    - Avoid   cross-contamination
    -   Sanitation of work surfaces
      CONTROL OF
  BIOLOGICAL HAZARDS
Destroy    pathogens introduced into
 the food
 – Proper cooking time and temperature
 – Freezing (for parasites)
 – Irradiation
      CONTROL OF
  BIOLOGICAL HAZARDS
 Prevent   growth of pathogens to harmful
 levels
  –   Refrigeration or freezing
  –   Avoid “DANGER ZONE” (40ºF - 140ºF)
  –   Decrease pH and/or water activity
  –   Hold food at elevated temperature (>140ºF)
      CONTROL OF
  BIOLOGICAL HAZARDS
 Reduce   pathogens to acceptable levels
  – Lactic acid rinses
  – Trisodium phosphate (TSP)
  – Acidified sodium chlorite (Sanova)
  – Chlorine
  – Others
BIOLOGICAL HAZARDS
Most food poisoning is the result of
 improper handling and cooking
CHEMICAL HAZARDS
CHEMICAL HAZARDS

 Chemical  Hazard – A substance that
 may cause an unacceptable health
 risk to the consumer through injury
 or illness
     LAWS AND
    REGULATIONS
 Food and Drug Administration
  (FDA)
 Department of Agriculture
  (USDA)
 Environmental Protection
  Agency (EPA)
  CHEMICAL HAZARDS
 Two   major categories of chemicals:
  – Prohibited substances
    Cyclamates

    Adhesives and resins from packaging materials

  – Natural poisonous or deleterious substances
    Aflatoxin

    Lead, Mercury
SOURCES OF CHEMICAL
 HAZARDS (Agricultural)
 Pesticides      Fungicides
 Herbicides      Antibiotics
 Fertilizers
 Insecticides
  SOURCES OF CHEMICAL
        HAZARDS
     (Food Processing)

 Preservatives       Packaging  materials
 Colors and dyes     Processing aids

 Flavor enhancers
 Water additives
  SOURCES OF CHEMICAL
        HAZARDS
    (Plant Environment)

 Sanitizers    Paints

 Pesticides    Ammonia

 Lubricants    Solvents

 Cleaners
CONTROL OF CHEMICAL
     HAZARDS
 On-the-Farm   HACCP plans
 Use only approved chemicals
 Control use of cleaners and sanitizers
 Integrated pest management program
       CONTROL OF
    CHEMICAL HAZARDS

 Use only food grade ingredients
 Use potable water
 Follow prerequisite programs for storage
  and shipping
 Letters of guarantee
PHYSICAL HAZARDS
  PHYSICAL HAZARDS
– Physical Hazards - Objects not
  normally found in food that can result in
  personal injuries (i.e. cuts to the mouth,
  choking, etc.)
 SOURCES OF PHYSICAL
      HAZARDS
Important   to separate those
 physical contaminates that can
 cause physical injury from those
 that are aesthetically unpleasing
 (ex. metal vs. hair)
 SOURCES OF PHYSICAL
      HAZARDS
 Metal              Hypodermic  needles
 Glass              Bullets/Buckshot
 Wood  splinters    Twist ties
 Jewelry            Bone
 Machine parts
SOURCES OF PHYSICAL
     HAZARDS
Contaminated    raw materials
Facilities and equipment
Production practices
Employee practices
CONTROL OF PHYSICAL
     HAZARDS
 Magnets               Riffle boards
 Metal detectors       Prerequisite

 Screens/Sifters        programs
 Bone separators       Letters of guarantee

 Visual inspections    Product
                         specifications
INITIAL STEPS IN
 DEVELOPING A
  HACCP PLAN
GAIN MANAGEMENT
     SUPPORT
             HA
             CCP
             Plan
ASSEMBLE THE HACCP
      TEAM
          The HACCP team
          includes
           – Coordinator
           – Ad hoc members
           – Outside experts

          Should be
          multidisciplinary
     MEMBERS OF THE
      HACCP TEAM
 Management
 Quality Control/Assurance
 Sanitation
 Maintenance/Engineering
 Production Supervisors
 Product Development/Sales
  EVALUATE CURRENT
      PROGRAMS
 Prerequisite programs and GMPs
 Sanitation Standard Operating
  Procedures (SSOPs) and SPSs
 Quality Control programs
 Training programs
 Compliance with regulations
Prerequisite Programs/GMPs
   Play an important role when conducting the
    HACCP plan hazard analyses

   If used in the hazard analyses, ALL programs
    must be in writing, monitored and records
    maintained

   Records must support decisions reached in the
    hazard analyses
           HACCP PLANS
 Must  be specific for both product and
  process
 Differences due to
  –   Suppliers
  –   Ingredients
  –   Formulations
  –   Processing equipment
  –   Facilities
  –   Preparation procedures
           HACCP PLAN
          DEVELOPMENT
 Describe the food and its’ intended use
 Develop a product description
  –   Process/Product name or type
  –   Important product characteristics
  –   Packaging and shelf life
  –   Where it will be sold
  –   Labeling instructions
  –   Special distribution control
      HACCP PLAN
     DEVELOPMENT
Prepare detailed
 information on
 the formula
 and ingredients
      HACCP PLAN
     DEVELOPMENT
Develop  a
 flow diagram
 of the process
         HACCP PLAN
        DEVELOPMENT
 Flow   diagrams must:
    Be developed for each product/process
    Include all processes from addition of raw
     materials through packaging and
     distribution
    Include rework and returned product (if
     applicable)
        HACCP PLAN
       DEVELOPMENT
   Verify the flow
    –On-site/hands-on
     verification
    –Keep it current
Seven HACCP Principles
1.   Hazard Identification and Assessment
2.   Critical Control Point Identification
3.   Establishing Critical Limits
4.   Monitoring Procedures
5.   Corrective Actions
6.   Verification Procedures
7.   Record Keeping Practices
HACCP PRINCIPLE
     NO. 1
  CONDUCT A
HAZARD ANALYSIS
 HACCP PRINCIPLE
      NO. 1
Develop  a list of hazards that are
 reasonably likely to cause injury or
 illness
Identify appropriate control
 measures for each hazard
HACCP PRINCIPLE NO. 1
 Hazards  are defined as biological, chemical
 or physical agents that are reasonably
 likely to cause injury or illness in the
 absence of control
HACCP PRINCIPLE NO. 1
Control   Measure - Any action,
 activity or device that can be used to
 prevent, eliminate, or reduce to an
 acceptable level a hazard
HACCP PRINCIPLE NO. 1
   Hazards associated with each step must be
    listed along with any control measures for them

   The term “control measure” is used because
    not all hazards can be prevented or eliminated


   Multiple control measures may be required for
    certain hazards
HACCP PRINCIPLE NO. 1
 When  conducting a hazard analysis
 consider:
  – Ingredients and raw materials
  – Each step in the process
  – Product storage and distribution
  – Final preparation and use by the
    consumer
HACCP PRINCIPLE NO. 1

 When  conducting a hazard analysis
 SAFETY concerns MUST be
 differentiated from QUALITY
 concerns
HACCP PRINCIPLE NO. 1
Hazard Analysis is a
 Two Step Process:
 –Hazard
  Identification
 –Hazard Evaluation
HACCP PRINCIPLE NO. 1
         Hazard   Identification
          – Brainstorming session
          – Review ingredients,
            process steps,
            storage/distribution and
            use
          – Develop a list of potential
            hazards which may be
            introduced, increased or
            controlled at each step
HACCP PRINCIPLE NO. 1
         Hazard   Evaluation
          – Determines which potential
            hazards must be addressed in
            the HACCP plan

          – Based on the severity and
            likely occurrence of each
            hazard
HACCP PRINCIPLE NO. 1
 Severity   - The seriousness of the
 consequences of exposure to the hazard


 Risk   - The likely occurrence of the
 hazard based on experience, technical
 literature, epidemiological data, etc.
HACCP PRINCIPLE NO. 1
 Hazards  identified in one facility may not
 be significant in another facility due to
 differences in equipment, preparation
 procedures, ingredients, etc.

 Maintain a summary of the hazard
 analyses for future reference and as
 required by regulation
            Control Measures for
             Chemical Hazards
Hazard                 Control Measure

Naturally Occurring    Supplier warranty/guarantee; monitoring program to
                       test for residues of hazardous substances
Substances
                       Supplier warranty/guarantee; specifications for each
Added Hazardous        raw material/ingredient; require suppliers to operate
Chemicals              with a HACCP plan; visit suppliers; monitoring
                       program to test for residues of hazardous chemicals

                       Identify all direct and indirect food & color additives
                       used in the processing operation; assure that each
In-Process Chemicals   chemical is approved; assure that each chemical is
                       properly used; record the usage of critical/restricted
                       ingredients where over usage may cause a serious
                       side effect
                Control Measures for
                 Physical Hazards
Hazard                  Control Measure
Raw Materials           Supplier’s HACCP plan; use of specs/guarantees;
                        vendor inspections and certifications; in-line magnets,
                        screens, traps, and filters; in-house inspection of
                        raw materials

Incoming Ingredients
                        Supplier’s HACCP plan; use of specs/guarantees;
                        vendor inspections and certifications; in-house
                        inspection of ingredients


Processing Operations   In-line metal detectors; visual product examinations;
                        frequent equipment inspections and proper equipment
                        maintenance
              Control Measures for
               Biological Hazards
Hazard                     Control Measure
Campylobacter jejuni       Proper cooking or pasteurization; avoiding cross-
                           contamination by insanitary equipment or food
                           handlers; freezing; controlled modified atmospheric
                           packaging
Escherichia coli O157:H7   Proper cooking; avoiding cross-contamination
                           by insanitary equipment or food handlers

                           Proper cooking or fermentation controls; avoiding
                           cross-contamination by insanitary equipment or
Salmonella spp.
                           food handlers; proper feed withdrawal prior to
                           slaughter; scalding procedures; decreased water
                           activity; antimicrobial treatments; separation of
                           raw & cooked products
HACCP PRINCIPLE NO. 1
A hazard analysis and identification of
 control measures assures:
 – Hazards and associated control measures are
   identified
 – Any necessary process modifications are
   identified
 – A basis for determining the CCPs is
   provided
HACCP PRINCIPLE
     NO. 2

 Determine Critical
Control Points (CCPs)
 HACCP PRINCIPLE
      NO. 2
Critical   Control Point:
  – A step at which control can be applied,
    and is essential, to prevent, eliminate, or
    reduce to an acceptable level a food
    safety hazard
   HACCP PRINCIPLE
        NO. 2
 Preventa food safety hazard
 Example - Modify a product formulation
 to reduce the pH below 4.6
   HACCP PRINCIPLE
        NO. 2
 Eliminate a food safety hazard
 Example - Thermally process a product
 to destroy a potential population of
 known pathogens
   HACCP PRINCIPLE
        NO. 2
 Reducea food safety hazard to
 an acceptable level
 Example – Apply antimicrobial
 treatments (i.e. chlorine, Sanova,
 etc.)
   HACCP PRINCIPLE
        NO. 2
 Examples   of CCPs include:
  – Zero Fecal Tolerance
  – Chilling Raw
    Product
  – Cooking
  – Chilling Cooked
    Product
Principle 2 - CCP Decision Tree
     Q1. Do control measure(s) exist for the identified hazard?

                                                      Modify step, process or product.
         YES                    NO

                            Is control at this step necessary for safety?            YES

                               NO          Not a CCP          STOP*

     Q2. Does this step eliminate or reduce the likely
     occurrence of a hazard to an acceptable level?


         NO                                                                    YES


     Q3. Could contamination with identified hazard occur in excess
     of acceptable level(s) or increase to unacceptable level(s)?

         YES           NO         Not a CCP           STOP*


     Q4. Will a subsequent step eliminate identified hazard(s)
     or reduce the likely occurrence to an acceptable level?

         YES      Not a CCP      STOP*      NO             CRITICAL CONTROL POINT
                                    *Proceed to next step in the described process



                                                                               Source: NACMCF. 1992.
Principle 2 - Modified Tree
   Q1. Does this step involve a hazard of significant likelihood of
   occurrence and severity to warrant its control?


           YES      NO        Not a CCP


     Q2. Does a control measure for the hazard exist at this step?


                     NO
                                       Modify the step, process, or product.


                    Is control at this step necessary for             YES
                    safety?
           YES



    Q3. Is control at this step necessary to prevent, eliminate, or
        reduce the risk of the hazard to consumers?



           YES        CCP         NO        Not a CCP
HACCP PRINCIPLE
     NO. 3

Establish Critical Limits
   HACCP PRINCIPLE
        NO. 3
Critical Limit:
 – A maximum and/or minimum value to
   which a biological, chemical or physical
   hazard must be controlled at a CCP to
   prevent, eliminate or reduce to an
   acceptable level the occurrence of a food
   safety hazard
   HACCP PRINCIPLE
        NO. 3
 Each  CCP must have a critical limit in order
  to determine whether the CCP is IN or OUT
  of control
 A CCP may have one or more critical limits
 A critical limit is used to distinguish between
  safe and unsafe operations at a CCP – it
  defines the “Boundaries of Safety”
     HACCP PRINCIPLE
          NO.3
 Criticallimits are established
  based on:

  – Evidence of the existence of a
    direct health hazard

  – Evidence that a direct health
    hazard could develop, or…
HACCP PRINCIPLE
     NO. 3
      – Indications that a
        product was not
        produced under
        conditions ensuring
        safety (i.e. metal
        detector kick-outs)
 HACCP PRINCIPLE
      NO. 3
 Criticallimits should:
  – Indicate control of a CCP
  – Be simple, specific and clear
  – Be based on scientifically determined
    parameters
  – Be quantifiable (but may be sensory)
  – Be validated
 HACCP PRINCIPLE
      NO. 3
 When   setting critical limits you:
 – May consider operational/target limits by
   using statistical process control (SPC)
 – May require consultation with experts
 – May require research
 – Should consider variations in equipment
   operation
 HACCP PRINCIPLE
      NO. 3
 Use   of target limits (through SPC)
  – Provides tighter control than a simple
    maximum/minimum critical limit
  – Helps to minimize or avoid costly corrective
    actions
  – Helps identify trends toward non-compliance
    before a deviation occurs
 HACCP PRINCIPLE
      NO. 3
 Example of variations in equipment
 operation:
 -   The critical limit for cooked chicken patties
     is an internal temperature of 160ºF for 1 sec.
 -   Equipment validation shows +/- 5ºF
 -   The adjusted critical limit for internal
     chicken patty temperature would be 165ºF
HACCP PRINCIPLE
     NO. 3
       Criticallimits may be
        derived from:
        – Regulatory standards
          (USDA, FDA, etc.)
        – Literature surveys
        – Experimental results
        – Data from outside experts
 HACCP PRINCIPLE
      NO. 3
 Examples   of critical limits:
  – Time/Temperature (chilling, cooking,
    freezing, etc.)
  – Zero Fecal Tolerance
  – Metal detector sensitivity
HACCP PRINCIPLE
     NO. 4

Establish Monitoring
    Procedures
 HACCP PRINCIPLE
      NO. 4
 Monitoring   is defined as:
  – Conducting a planned sequence of
    observations or measurements to assess
    whether or not a CCP is under control
    and producing an accurate record
    thereof for future use in verification
 HACCP PRINCIPLE
      NO. 4
Monitoring   serves three main
 purposes:
 – It assesses control
 – It determines trends
 – It provides written documentation
  HACCP PRINCIPLE
       NO. 4
• Continuous Monitoring is best,
  however, Less Than Continuous
  Monitoring may be more
  practical
• It is not necessary to
  always have continuous
  monitoring
HACCP PRINCIPLE
     NO. 4
 Continuous  Monitoring:
  – Temperature
  – pH
  – Time
  – Chlorine level
 HACCP PRINCIPLE
      NO. 4
 Less Than Continuous Monitoring:
  – Statistical sampling
  – Monitoring at set intervals of time
      HACCP PRINCIPLE
           NO. 4
 LessThan Continuous Monitoring is
 often used:
  -   When conditions are unknown (i.e.
      ingredient testing)
  -   For troubleshooting (i.e. lot sampling)
  HACCP PRINCIPLE
       NO. 4
Important   monitoring questions:
 – What is monitored
 – Who monitors (by title, not name)
 – How is monitoring performed
 – What is the frequency of monitoring
HACCP PRINCIPLE
     NO. 4
   Individuals must fully understand
    the purpose and importance of
    monitoring
   Individuals must be trained in the
    monitoring techniques (i.e. SOP)
   Individuals must be unbiased in
    monitoring and reporting
   Individuals must accurately
    record the results of monitoring
  HACCP PRINCIPLE
       NO. 4
 Employees should be trained in procedures
 to follow when there is a trend towards loss
 of control

 Allmonitoring records must be dated and
 initialed, or signed, by the person doing the
 monitoring
 HACCP PRINCIPLE
      NO. 4
 Monitoring procedures need to be rapid,
 on-line and “real time”

 Microbiological   tests are seldom effective
 for monitoring
HACCP PRINCIPLE
     NO. 4
     Monitoring  Records:
      – Data entered must be
        accurate and timely
      – Free of errors or omissions
      – Free of whiteouts, erasures,
        blackouts, etc.
   HACCP PRINCIPLE
        NO. 4
 Monitoring   records must be:
  – Reviewed, dated and signed, or initialed, by
    someone other than the monitoring person
    (i.e. verification)
  – Reviewed prior to shipment of the associated
    product (i.e. pre-shipment review)
  – Made available to USDA personnel upon
    request
  – Retained as required by USDA regulations
HACCP PRINCIPLE
     NO. 5

Establish Corrective
      Actions
  HACCP PRINCIPLE
       NO. 5
Deviation:
 – A failure to comply with a stated critical
   limit
 – Corrective actions must be developed for
   each CCP to remedy an associated
   deviation and assure product safety
 – Corrective actions “FIX” the deviation
   and assure compliance with the HACCP
   plan is maintained
 HACCP PRINCIPLE
      NO. 5
 The HACCP plan shall describe the
 corrective actions to be taken, and assign
 the responsibility for taking each one
HACCP PRINCIPLE
     NO. 5
   Corrective actions must ensure:
    – The cause of the deviation is identified and
      eliminated
    – The CCP is/will be under control after corrective
      actions are taken
    – Measures to prevent recurrence are/have been
      established
    – No product that is injurious to health or otherwise
      adulterated as a result of the deviation enters
      commerce
   HACCP PRINCIPLE
        NO. 5
 Inmany cases, critical limit
 monitoring will identify
 when a process is trending
 toward noncompliance
 prior to a deviation actually
 occurring
HACCP PRINCIPLE
     NO. 5
      Employees should be trained on the
       proper corrective actions to take in
       response to deviations of the CCPs for
       which they are responsible

      The first action that should be taken is
       to get control of/address the affected
       product (i.e. place it on HOLD, etc.)
  HACCP PRINCIPLE
       NO. 5
A person with a thorough knowledge of
 the process, products and HACCP plan
 should have oversight of the corrective
 actions
    HACCP PRINCIPLE
         NO. 5
   All corrective actions must be thoroughly, and
    accurately, recorded

   Recommend designing a Corrective Action
    Form that forces employees to address all 4
    requirements of HACCP Corrective Actions
HACCP PRINCIPLE
     NO. 6
Establish Verification
Procedures
 HACCP PRINCIPLE
      NO. 6
 In   a “perfect world” all that is needed
 is:
  – Flow diagrams & hazard analyses
  – Critical control points
  – Monitoring procedures
 HACCP PRINCIPLE
      NO. 6
In   the “real world” HACCP
 requires periodic, independent,
 verification checks
  HACCP PRINCIPLE
       NO. 6
Verification evaluates the day-to-day
 compliance of the activities conducted
 at each CCP
It assures we say what we do and do
 what we say
 HACCP PRINCIPLE
      NO. 6
 An important aspect of verification is
 the initial validation of the HACCP
 plan that determines the plan is
 scientifically and technically sound
  HACCP PRINCIPLE
       NO. 6
 Types  of ongoing CCP verification
 activities:

  – Calibration of process-monitoring
    equipment
HACCP PRINCIPLE
     NO. 6
     – Review of records

     – Direct observations of the
       adequacy of monitoring
       activities and corrective
       actions
  HACCP PRINCIPLE
       NO. 6
 Calibration   of process-monitoring
 equipment
  – Checked at a frequency sufficient to
    ensure that all measurements are
    accurate
HACCP PRINCIPLE
     NO. 6
– Frequency dependent on the
  likelihood that the instrument will
  go out of calibration
– Frequency dependent on the level
  of process liability you are willing
  to accept
   HACCP PRINCIPLE
        NO. 6
 Calibration   records should include:
  – Identification of the equipment calibration
    checked
  – Date, time, and signature/initials of the person
    who checked the equipment calibration
  – Identification of the reference instrument used to
    check calibration
HACCP PRINCIPLE
     NO. 6
– Results of calibration check
– Date and signature/initials of who reviewed
  the record
 HACCP PRINCIPLE
      NO. 6
 Monitoringand corrective action
 records should be reviewed:

  – By an individual other than the one
    who prepared the records
HACCP PRINCIPLE
     NO. 6
– By a Supervisor,
  or other member
  of management,
  who has received
  HACCP training
 HACCP PRINCIPLE
      NO. 6
 Reviewof monitoring records is
 intended to verify:
  – The record was prepared correctly
  – Activities and frequencies were
    performed as required by the HACCP
    plan
HACCP PRINCIPLE
     NO. 6

– No monitoring activities were
  missed

– Findings were within critical limits
  and all deviations were identified
HACCP PRINCIPLE
     NO. 6
       Review of corrective
       action records is
       intended to verify:

        – The record was prepared
          correctly

        – The nature and extent of
          the deviation was clearly
          documented
HACCP PRINCIPLE
     NO. 6
– Affected product was identified and
  isolated
– Corrective actions followed those
  stated in the HACCP plan
– Final disposition of product and
  individuals involved are stated
 HACCP PRINCIPLE
      NO. 6
 Review of monitoring/corrective action
 records should ensure:

  – All entries have been made in pen

  – There are no whiteouts, erasures, blackouts,
    etc.
HACCP PRINCIPLE
     NO. 6
– There is no evidence of falsification


– Person making the entries has signed or
  initialed the record
HACCP PRINCIPLE
     NO. 6
   Direct observations
    of the adequacy of
    monitoring activities
    and corrective
    actions should be
    conducted
     – Actual results of
       these observations
       must be recorded
HACCP PRINCIPLE
     NO. 6
Targeted   sampling and testing
 – It may, at times, be necessary to
   verify a process by performing
   periodic sampling and testing
   independent of the monitoring
   activity
HACCP PRINCIPLE
     NO. 6
   Microbiological Testing
    – Not recommended for HACCP monitoring
       Length of time required to obtain results

       Detection sensitivity



    – If used for HACCP verification, sampling
      and testing frequency must be specified in
      the HACCP plan
 HACCP PRINCIPLE
      NO. 6
 Microbiological  test results are only as
 reliable as the sampling and analytical
 methods used
 HACCP PRINCIPLE
      NO. 6
 Extensivesampling is required to
 achieve reliable detection in samples
 containing low levels of pathogens
HACCP PRINCIPLE
     NO. 6
 Validation and reassessment of the
 HACCP plan are the most complex
 verification activities that must be
 performed
 HACCP PRINCIPLE
      NO. 6
         and reassessment of the
 Validation
 HACCP plan answer the questions

  – Is it the right thing to do

  – Is it STILL the right thing to do
   HACCP PRINCIPLE
        NO. 6
 HACCP plan   validation occurs:

  – During development/initial implementation
    of the HACCP plan

  – Following implementation of modifications to
    the HACCP plan
HACCP PRINCIPLE
     NO. 6
     HACCP   plan validation
     is supported by:
     – Regulatory requirements
     – Scientific data and
       literature
     – Plant test data/results
HACCP PRINCIPLE
     NO. 6
 Eventsthat trigger a HACCP plan
 reassessment
  – Length of time since the last reassessment
    (conducted annually, at a minimum)
  – Whenever any changes occur that could
    affect the hazard analysis or alter the
    HACCP plan (system modifications, etc.)
HACCP PRINCIPLE
     NO. 6
- Whenever a deviation not covered by a
  specified corrective action occurs (aka an
  unforeseen hazard)
     Foodborne disease outbreak
     Recall of products

- Repetitive failures of the same CCP
HACCP PRINCIPLE
     NO. 7
      Establish
      Effective
      Record
      Keeping
      Practices
   HACCP PRINCIPLE
        NO. 7
 Records   are kept for several
 reasons:
  – Evidence of product safety
  – Regulatory compliance
  – Tracing product
  – Review of procedures/processes
HACCP PRINCIPLE
     NO. 7
The  HACCP
 plan should be
 included as part
 of the plant’s
 records
HACCP PRINCIPLE
     NO. 7
  Active   HACCP records include:
       -    CCP monitoring records
       -    CCP verification records
       -    Calibration records
       -    Corrective action records
       -    Other records (ex. sample
            results, etc.)
      HACCP PRINCIPLE
           NO.7
 Content    of the HACCP records:
  –   Form title and date of issue
  –   Production date/product code
  –   Observations and measurements
  –   Critical limits/corrective actions
  –   Monitor’s signature/initials and date
  –   Reviewer’s signature/initials and date
    HACCP PRINCIPLE
         NO.7
 OtherHACCP files
 include:

  – HACCP Team Members
     Listing
     Responsibilities
     Outside experts/contacts
  HACCP PRINCIPLE
       NO.7
– Reference/supporting data
  related to selection of CCPs,
  critical limits, monitoring
  procedures, corrective actions,
  etc.
 HACCP PRINCIPLE
      NO.7

– Standard Operating Procedures (SOPs) for
  each CCP
– HACCP training information
   Who was trained
   Types of training received
   Training certificates
PRE-SHIPMENT REVIEW

       Priorto shipping
       product, the
       establishment shall
       review the records
       associated with the
       production of that
       product…
 PRE-SHIPMENT REVIEW
 To   determine/assure:

  – All critical limits were met
  – Appropriate corrective actions were taken,
    including the proper disposition of product
PRE-SHIPMENT REVIEW

 Review should be conducted, dated
 and signed by someone other than the
 person that produced the records, and
 trained in accordance with § 417.7
             HACCP RECORD
              RETENTION
   One Year
    – Slaughter
    – Refrigerated products
   Two Years
    – Frozen, preserved, shelf stable
      products
 On-site – 6 months
 Off-site after 6 months if they
  can be retrieved/provided within
  24 hrs. of the FSIS request
         ACCESS TO HACCP
            RECORDS
   USDA/FSIS must have access to all HACCP plans,
    procedures and records

   Copies of HACCP plans, procedures, records and
    supporting documentation should not be given to
    FSIS inspector for their files
        ACCESS TO HACCP
           RECORDS
 AllHACCP documents should be
 marked “Confidential Proprietary
 Information” (or its equivalent) and
 treated as such
 RECORDS MAINTAINED
    ON COMPUTERS
 Acceptable, provided appropriate
 controls are implemented to ensure
 the integrity of the electronic data
 and signatures
   HACCP DOCUMENT
      CONTROL
 Maintain  a list of controlled
 copies of the HACCP plan

 Anyproposed amendments to the
 HACCP plan must go through a
 planned sequence for approval
 (SOP)
HACCP DOCUMENT
   CONTROL
     A system   of auditing needs
      to be in place to ensure that
      all copies of the HACCP plan
      are updated when any
      amendments are made

     Amended    pages of the
      HACCP plan must be
      indicated in some manner
    HACCP DOCUMENT
       CONTROL
 An  amendment form could include:
    Date; Subject; Sub-section or page
    number; Comments; Approval
    signatures/initials
 Pages of the HACCP plan could show:
    Amendment number; Date;
    Approved signatures/initials
    HACCP DOCUMENT
       CONTROL
 Once the number of amendments
 becomes excessive, consider
 reissuing the HACCP plan

 Save“old” HACCP plans to
 correlate with the HACCP records
 produced under them
HACCP DOCUMENT
   CONTROL
  – Establish a filing system for the
    HACCP plan, associated records
    & supporting materials
    Accessible   to plant and FSIS
     personnel
    Provide adequate security

    Signout sheet if removed from
     location (including the FSIS
     inspector)
  9 CFR PART 417

HAZARD ANALYSIS AND
  CRITICAL CONTROL
POINT (HACCP) SYSTEMS
§ 417.1 Definitions
a.   Corrective action
b.   Critical limit
c.   Food safety hazard
d.   HACCP System
e.   Hazard
f.   Preventive measure
g.   Process-monitoring instrument
h.   Responsible establishment official
§ 417.2 Hazard Analysis and HACCP
        Plan
a) Hazard Analysis
1) Every official establishment shall conduct a
   hazard analysis to determine the food safety
   hazards reasonably likely to occur in the
   production process and identify the
   preventive measures that can be applied to
   control those hazards
2) A flow chart describing the
   steps of each process and
   product flow shall be
   prepared, and the intended
   use or consumers shall be
   identified
3) Food safety hazards might be
   expected to arise from:

  a. Natural toxins
  b. Microbiological contamination
  c. Chemical contamination
  d. Pesticides
  e. Drug residues
  f. Zoonotic diseases
  g. Decomposition
  h. Parasites
  i. Physical hazards
b) The HACCP plan
1) Every establishment shall develop and
   implement a written HACCP plan
   covering each product produced by
   the establishment
2) A single HACCP plan may encompass
   multiple products within a single
   processing category
     Process Categories
 Slaughter   – all species
 Raw product – ground
 Raw product – not ground (ex.
  steaks, chops, parts, etc.)
 Thermally processed – commercially
  sterile (ex. canned meat and poultry)
     Process Categories
 Not heat treated – shelf stable (ex.
  dried, dehydrated and freeze dried
  products, etc.)
 Heat treated – shelf stable (ex.
  rendered products, lard, etc.)
 Fully cooked – not shelf stable (ex.
  hams, roast beef, cooked beef, etc.)
     Process Categories
 Heat  treated but not fully cooked –
  not shelf stable (ex. partially cooked
  battered, breaded and ready-to-cook
  products, etc.)
 Product with secondary inhibitors –
  not shelf stable (ex. fermented, dried,
  salted and brine treated products,
  etc.)
c) The contents of the HACCP
  plan – the HACCP plan shall:
  1) List the food safety hazards that
     must be controlled for each process
  2) List the critical control points for
     each identified food safety hazard
  3) List the critical limits that must be
     met at each CCP
  4) List the procedures and frequency
     used to monitor each CCP
5) Include all corrective actions to be
   followed in response to any deviation
   from a critical limit at a CCP
6) Provide for a record keeping system
   that documents the monitoring of the
   CCPs
7) List the verification procedures and
   their frequency
d)   Signing and dating the HACCP
     plan
     1) The HACCP plan shall be signed and
        dated by the responsible establishment
        individual
     2) The HACCP plan shall be signed and
        dated: upon initial acceptance; upon
        any modification; and at least annually
        upon reassessment
e) Failure of an establishment to
   develop and implement a
   HACCP plan may render the
   products produced under those
   conditions adulterated
§ 417.3 Corrective actions
a) The written HACCP plan shall
   identify the corrective action to be
   followed in response to a deviation
   from a critical limit, and assign
   responsibility for taking corrective
   action, to ensure…
1) The cause of the deviation is
   identified and eliminated
2) The CCP will be under control
   after the corrective action is taken
3) Measures to prevent recurrence
   are established
4) No product that is injurious to
   health or otherwise adulterated as
   a result of the deviation enters
   commerce
b) If a deviation not covered by a
   specified corrective action occurs:
  1) Segregate and hold the affected product
  2) Perform a review to determine the
     acceptability of the affected product
  3) Take action to ensure that no product that is
     injurious to health or otherwise adulterated
     enters commerce
  4) Perform a reassessment to determine
     whether or not the newly identified
     deviation should be incorporated into the
     HACCP plan
c) All corrective actions taken
   shall be documented in records
   that are subject to verification
   and record keeping
   requirements of this part
§ 417.4 Validation, Verification,
        Reassessment
a) Every establishment shall validate
   the HACCP plan’s adequacy in
   controlling the food safety hazards
   identified during the hazard analysis,
   and shall verify that the plan is being
   effectively implemented
(1) Initial validation
     Designed to determine that the HACCP
     plan is functioning as intended


(2) Ongoing verification activities
     The calibration of process-monitoring
     instruments
     Direct observation of monitoring activities
     and corrective actions
     Review of records
(3) Reassessment of the HACCP plan
 At least annually, and whenever any changes
  occur that could affect the hazard analysis or
  alter the HACCP plan
 The HACCP plan shall be modified
  immediately whenever reassessment reveals the
  plan no longer meets regulatory requirements
§ 417.5 Records
a) The establishment shall maintain the
   following records documenting the
   establishment’s HACCP plan:
  1) The written hazard analysis including all
     supporting documentation
  2) The written HACCP plan including
     decision-making documents
  3) Records documenting the monitoring of
     CCPs and their critical limits
b) Each entry on a record maintained
   under the HACCP plan shall be made
   at the time the specific event occurs

c) Prior to shipping product, the
   establishment shall review the records
   associated with the production of that
   product, then sign and date each
   record
d) Records maintained on computers -
   Acceptable, provided appropriate controls
   are implemented to ensure integrity of
   electronic data/signatures
e) Record retention:
   1) Slaughter and refrigerated products – 1
      year
     Frozen, preserved, or shelf stable
     products - 2 years
   2) Off-site storage of records – Permitted
      after 6 months if they can be retrieved
      and provided within 24 hrs. of request
f) Official review – All records, plans and
   procedures required by this part shall
   be available for official review
§ 417.6 Inadequate HACCP Systems
A HACCP system may be found to be
inadequate if:
    a) The HACCP plan in operation does
       not meet the requirements of this
       part
    b) Establishment personnel are not
       performing tasks specified in the
       HACCP plan
c) The establishment fails to take
   corrective actions
d) HACCP records are not being
   maintained
e) Adulterated product is produced
   or shipped
§ 417.7 Training
a) Only an individual who has met the
requirements of paragraph (b) of this section
shall be permitted to perform the following
functions:
     1) Development of the HACCP plan
     2) Reassessment and modification of the
        HACCP plan
b) The individual performing the functions
listed in paragraph (a) of this section shall
have successfully completed a course of
instruction in the application of the seven
HACCP principles to meat and poultry
product processing, including a segment on
the development of a HACCP plan for a
specific product and on record review
§ 417.8 Agency Verification

  FSIS verification of the adequacy of the
  HACCP plan(s) may include:
  a) Reviewing the HACCP plan
  b) Reviewing the CCP records
  c) Reviewing and determining the
     adequacy of corrective actions
  d) Reviewing the critical limits
e) Reviewing other records pertaining to
   the HACCP plan or system
f) Direct observations or measurements
   at CCPs
g) Sample collection and analysis
h) On-site observations and record
   reviews
  Thank you very much
           and
Best wishes for your future
       endeavors!!!

				
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