HACCP
•Monitoring Definition (NACMCF):
"*A planned sequence of observations* or measurements to assess *whether a CCP is under control* and *produce an accurate record* for future use in verification"
"test and hold" within the beef industry
"N-60" Sampling Method
1996: National Residue Program's purpose...
"is intended to provide Verification of residue control by HACCP Systems."
Adequate Ventilation
(1) Minimize *odors, vapors*, steam and noxious fumes in food areas (2) Locate and operate *fans to minimize contamination* of food, food-contact surfaces and packaging material (3) *Screening* or other protection against *pests*
proper hygienic practices
(1) Outer garments to protect food from contamination (2) Maintain adequate personal cleanliness (3) Thorough *washing and sanitizing of hands* in an adequate wash facility before starting work, after each absence from the work station and at any other time when soiled (5) *Maintain* impermeable *gloves* in an intact, clean and sanitary condition (6) *Wear hair nets*, caps, snoods, or other hair restraints as appropriate (7) Store *clothing away* from food, equipment and utensils (8) *No eating*, gum chewing, beverage drinking or smoking in areas exposed to food, equipment or utensils (9) Remove (or cover) unsecured jewelry (10) Take *additional precautions* as needed to prevent contamination of food by perspiration, hair, cosmetics, tobacco, chemicals and topical medicines
Facility Construction and Design - *Protect food* in outdoor bulk storage vessels
(1) Protective *coverings* (2) Eliminate *harborages* for pests (3) Regular checks for pests (4) Skimming vessels as necessary
Construction design:
(1) Readily cleanable materials constructed for *easy cleaning* of walls, floors, and ceilings (2) *Prevent drip/condensate* on fixtures, ducts and pipes from contaminating food, food-contact surfaces and food packaging materials (3) *Provide aisles/working spaces* between equipment and walls for proper cleaning/ sanitation
Current Good Manufacturing Practices (cGMP's) - definition of *adulterated food*
(Food, Drug and Cosmetic Act) - Food has been manufactured under such conditions that are *unfit for human consumption*
revalidation is termed...
*"reassessment"* by USDA and FDA
______________ spice imports contaminated with insect parts, whole insects, rodent hairs and other things
*12% of U.S.*
_________________ spices hold bacteria and harmful chemicals
*4 out of 10*
Acidified foods at pH <
*4.6*
verification of prerequisite programs
*Annual review* of written procedures and quality systems audit reports; Prerequisite programs (PRP) for *calibration* of all detection and measurement *instruments* (also under HACCP plan for CCPs)
critical limits are used to...
*Determine if the control measure at the CCP is "in" or "out" of control*
step two of determining CCPs with a decision tree
*Determine* if the step is a CP or CCP
validating the HACCP plan
*Done by the HACCP* team during initial implementation of the HACCP plan
step one of determining CCPs with a decision tree
*Evaluate each step* where food safety hazards can be prevented, eliminated or reduced to acceptable levels
Alternatives to decision tree:
*Experience and knowledge* of the process and existing control measures
building and facilities cGMPs
*Grounds: protect against food contamination* -Proper equipment storage -Removal of litter and waste -Weed / grass cutting -Proper maintenance of roads, yards and parking lots -Adequate *drainage* to prevent seepage, foot-borne filth and *pest breeding* areas -*Adequate waste* treatment and disposal
Focused solely on _____________- not product quality
*HAZARDS*
Jack in the Box outbreak outcome
*Jumpstarted the implementation of HACCP* principles in the ground beef industry
first application of HACCP: ground beef
*McDonald* Corporation's ground beef patty producers worked with *Colorado State University* to develop and teach a HACCP plan to beef packers
Industrial Cooking Challenges
*Must ensure proper cooking and cooling to maintain product quality and safety*! • Food must be *cooked* to proper internal temperature. • Cooked food needs to be *cooled* down to the right temperature within acceptable time frame. • Frozen food must be *defrosted* to the correct temperature within acceptable time frame. • *Create, maintain, and store temperature/time records* for inspectors and management • *Fully automated records* of temperature/time data for cooking, tempering, and defrosting processes. • Cloud-based log of all data for instant monitoring access and report generation. • *Automatic alerts*
Setting Critical Limits
*Non-government food safety criteria* •Processing authorities/experts •Scientific literature •Trade associations •University extension •In-plant studies / research •Equipment manufacturers
Human Food Manufacturing Areas
*Not used to* manufacture non-human food- grade animal feed
discontinuous monitoring
*Periodic measurements* or observations
Meat and Poultry Products (9 CFR 308 and 381) Provide criteria for complying with provisions of the *Federal Meat Inspection Act* and the...
*Poultry Products Inspection Act*
Reassessment (Revalidation) -
*Response to situations* that may affect the effectiveness of the HACCP system.
February 2016, The USDA - FSIS has announced new pathogen reduction performance standards for...
*Salmonella and Campylobacter in ground chicken and turkey products, plus raw chicken breasts, legs and wings*
step three of determining CCPs with a decision tree
*Summarize* results and add to the HACCP plan
record definition
*Written evidence* that documents a task
Instruments for measuring, regulating and maintaining temperature, pH, acidity, aw, or other parameters must be...
*accurate and adequately maintained*
tolerances for physical hazards established by FDA in Compliance Policy Guide, Section 555.425, "Foods - Adulteration Involving Hard or Sharp Foreign Objects"; Classifies a product that is ready-to-eat as being adulterated if it contains a hard or sharp foreign object that measure 7 mm (0.28 in) to 25 mm (0.98 in) in length. (Under 7 mm is a hazard if intended for children or the elderly). note this regulation is not for...
*aesthetically unpleasing* objects: For example: Strands of hair, thread, paper etc
Principles of HACCP can be applied to...
*all phases of food production*, from basic agriculture to food preparation and/or processing
*All records* generated from the equipment should be *reviewed* and the establishment should...
*assess* the potential *impact on the safety of products* produced from the last acceptable check
FDA and USDA regulate that any HACCP plan must contain...
*at least 1 CCP*
revalidation is conducted...
*at least annually* on the entire HACCP plan
Results from decision tree can sometimes defy...
*common sense*
corrective actions are required for...
*every CCP*
HACCP is Applicable from...
*farm-to-fork*
FDA recommends written SSOP's for...
*fish and seafood*
record-keeping and documentation Focus only on...
*food safety*
Under FDA, HACCP came to...
*juice and seafood*
The method of *cooking and the temperature* to which products are cooked significantly affect the...
*lethality of the cooking process*, and the overall safety of the product.
1996: Final Rule announced by FSIS-USDA
*list four essential elements* to reduce the contamination of meat & poultry and the risk of foodborne illness
USDA mandates SSOP's for...
*meat and poultry processors*
Minimize potential for ___________________ in all manufacturing operations including packaging and storage
*microbial growth*
Microbiological sampling and testing are essential but...
*never appropriate* monitoring procedures
record-keeping and documentation provide a mechanism to...
*notice patterns* and identify *potential problems*
Record the information at the time it is...
*observed* or measured
validation/verification is...
*piecing together* the entire HACCP "puzzle"
Identification of CCP's based on _____________________ for controlling hazards
*previous hazard analysis*
we must prove that the product is _________ (critical control point - monitoring and verification)
*safe*
Opinions will differ on ______________________ of occurrence; outside consultants are used
*severity and likelihood*
Production and Process Controls compliance verified by any effective analytical method including a...
*supplier's guarantee or certification*
Records must be...
*timed, dated, and signed/initialed* by plant personnel making the entry
record-keeping and documentation are a means of...
*tracing the history* of ingredients and products
Maintain __________________- of discussion
*written record*
revalidation - end result
- *A report* detailing the findings - *Replaces* out-of-date versions of the HACCP plan - A report maintained *as part of HACCP record*
Implementation of the HACCP Plan requires...
- *Commitment* from top management - List *HACCP coordinator and team* responsible for developing, implementing and maintaining the HACCP system - *Initiate product teams* to develop HACCP plans for specific products (requires training) - *Develop timeline* of activities for HACCP plan development and implementation
record-keeping procedures: USDA requirements
- *Date and time* of activity - Date, time, *sign/initial* each data entry - *Processing information* entered when observed - *Reviewer's signature* and date of review
hazard evaluation
- *Decide what hazards* must be included in the HACCP plan based on: *severity* and *likelihood* of occurrence
Qualifications for monitoring
- *Educated* about the importance of accurately recording and reporting unbiased results - Adequately trained to: perform monitoring, make process adjustments, initiate corrective actions, maintain records
inspectors jobs:
- *Ensure SSOP and HACCP plans* are within regulatory requirements - *Verify plants* follow SSOP, HACCP, and micro testing procedures correctly - *Write up* Non-compliance Records (NRs) to document deviations from regulation - *Take needed action* when a plant is non complying with regulation requirements
verification by regulatory agencies
- *Industry*: Develop and implement HACCP - *Regulatory Agencies*: Determine if the HACCP plan is effective and being followed?
Other Uses For Monitoring
- *Make adjustments before a deviation* in critical limits occurs - *Review records for trends* that could adversely impact future product safety (Recalibrating instruments, Repairing/replacing equipment, Altering processing procedures)
revalidation - questions to ask
- *New hazards* not addressed in HACCP plan - CCPs and control measures *still appropriate* - Critical limits *still adequate* - Monitoring, corrective action and record-keeping *appropriate*
three areas of verification
- *Prerequisite* programs - *CCPs*: calibration, monitoring / corrective action records, independent checks - *HACCP plan*
Drawbacks of HACCP
- *Production companies' responsibility* (Shift from USDA monitoring to the plants needing to maintain records themselves) - *Employee participation* (Requires effort from the entire team, from all shifts and departments) - *Costs* (Remodeling, Replacing old equipment, Sampling materials, Validation, etc.)
Considerations when conducting a hazard analysis
- *Raw materials and ingredients* during storage, processing, product storage, distribution and final preparation - *A thorough hazard analysis* is the KEY to preparing an effective HACCP plan
Maintenance of the HACCP Plan requires...
- *Regularly* scheduled verification activities - HACCP plan *updated* and revised as needed - *Proper training* and importance of individual roles in maintaining effectiveness
Maintenance of the HACCP Plan
- *Regularly* scheduled verification activities - HACCP plan *updated and revised* as needed - *Proper training* and importance of individual roles in maintaining effectiveness
CORRECTIVE ACTION RECORDS
- *Required by FDA and USDA* and open to review - *Reason* action was taken - Reasoning *behind disposition* (testing sometimes required) - *Number of units* and product codes affected - *Method of disposal*
Developing SSOP's for Fish and Seafood - required monitoring:
- *Safety of water and ice* in contract with food - Condition and cleanliness of food contact surfaces including utensils, gloves and outer garments - prevent *cross contamination from unsanitary objects* to food (and items coming in contact with food) - prevent cross-contamination *between raw and cooked product* - adequate *hand washing*, hand sanitizing and toilet facilities - *protect food*, packaging materials and food contact surfaces from physical, chemical and biological adulterants - *proper labeling*, storage and use of toxic compounds - control of *employee health*
Early Uses of HACCP
- 1973 - *Training of FDA inspectors* in the element of HACCP and *instituted HACCP inspections* of food plants - Numerous *conferences and sessions* on HACCP including symposium at IFT 1974 - 1970's - *Low acid canning* was first to have the concept of HACCP under FDA. - Late 1970's and 1985 - Decreased interest except for a few large companies (Pillsbury, del Monte). - On its own, *Pillsbury implemented HACCP* at all its facilities by 1974
Codex Alimentarius Committee on Food Hygiene
- A committee of the United Nations WHO/FAO Codex Alimentarius Commission - *Develop HACCP guidelines for international trade* - Work closely with NACMCF to define and refine HACCP principles and guidelines
decision tree
- A useful tool (optional in HACCP) - Not a substitute for expert knowledge
Food and Drug Act
- Administered by FDA: Food and Drug Administration (Not USDA) under Department of Health and Human Services - Responsible for *oversight of all other foods* including shelled eggs, wild game meats, fish, seafood, plus drugs, cosmetics, and medical devices
outcome of hazard analysis
- All production steps - Potential hazards associated with each production step - Justification of hazard - Hazard addressed in HACCP plan? (severity and likelihood of occurrence) - Control measure
Disposal method for product that cannot be reused
- Animal feed - Landfill - Incineration
Preliminary Tasks to Develop HACCP
- Assemble HACCP Team - Product Description (Identify Intended Use and Consumers of Food) - Develop Flow Diagram - Verify Flow Diagram
locations of CCPs
- At steps where the *hazard can be prevented*, eliminated or reduced to acceptable levels - *Examples*: Thermal processing, chilling, product formulation control, testing for physical hazards
3 different categories of hazards
- Biological - Physical - Chemical
*components to hazard analysis:*
- Biological (major emphasis) - Chemical - Physical
initial validation:
- CCP verification (and calibration) *records* - Corrective action *records*: comply with any regulatory requirements - Previous audit *reports*: chronic problem areas (deli-style showcase)
Outcome of determining critical control points
- CCP's documented - Differ for the same product based on the facility
Implementation and Maintenance of the HACCP Plan
- Commitment from top management - List *HACCP coordinator* and *team responsible* for developing, implementing and maintaining the HACCP system - *Initiate product teams* to develop HACCP plans for specific products; Appropriate training - *Develop time line* of activities for HACCP plan development and implementation
how to control "growth of"
- Control over temperature, acidity, water activity, and atmosphere through: FSIS Inspection, FSIS Prerequisite Programs, FDA cGMPs and 8 Key Sanitation Conditions, HACCP System - spore germination: Some bacteria can sporulate: Spores survive cooking, germinate; allowing bacteria to produce toxins - both before human consumption or an enterotoxin after consumption - toxin production: Non-sporeforming bacteria multiply and inoculate the food with heat stable enterotoxins that cannot be destroyed through cooking - Temperature control is necessary to prevent spore germination and/or destroy toxin: Autoclave (retort) will kill spores and destroy toxin
NACMCF in november 1989:
- Created *seven principles of HACCP* - Endorsed the use of HACCP by industry and regulators - Provided a HACCP plan development guide for specific foods.
procedures to establish corrective actions
- Determine *what to do* when a deviation occurs - Determine *who is responsible* for implementing the corrective action - Determine the *disposition* of the non-compliant product (consult experts?) - Determine who will *develop and maintain* a record of the event
Prerequisites *vs HACCP*
- Deviation: unlikely to result in injurious products *vs serious consequences* - Generally managed in quality programs *vs food safety only* - Broad programs and multiple lines *vs Specific product and line* - Difficult to associate a failure with a particular lot *vs easy to point out a failure with a particular lot*
determining critical limits
- Each CCP will have *one or more control* measures with one or more *critical limits* - Based on temperature, time, physical dimensions, humidity, moisture (aw), pH, titratable acidity, available chlorine, preservatives or sensory attributes
noncontinuous effective monitoring procedures
- Establish a *reliable frequency* and procedure - Statistically based *data collection* or sampling plans
verification is based on:
- Expert advice / scientific studies - In-plant observations, measurements and evaluations
validating the HACCP plan - Validation tools
- Experts - *Scientific literature/studies* - In-plant observations/*measurements* - *Records*: CCPs, monitoring, corrective action
National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
- First meeting in 1988 - *Scientific advisory committee* to the Secretaries of Agriculture, Commerce, Defense and Health & Human Services - *encourage adaption* of the HACCP approach to food safety
verification is reviewed periodically by an unbiased independent authority- internal, external experts, regulatory agencies:
- Flow diagram - Hazard analysis - Each HACCP step - Appropriate records
Industry concerns of HACCP
- HACCP as a *required regulation* to be widely utilized - Regulatory *access to company records*
revalidation - who
- HACCP team - independent individual - independent HACCP team
purpose of Conducting a Hazard Analysis
- Identify *hazards* and associated *control measures* - Identify any needed modifications to product or process to better *ensure product safety* - Provide *a basis* for determining *CCP's* in Principle 2
FSMA: imported food safety
- Importer accountability (*Importers must verify* foreign suppliers produce food with adequate preventative controls) - Third Party Certification (*Qualified third parties* can certify that foreign food facilities comply with U.S. food safety standards) - Certification for high risk foods (FDA has the authority to require that *high-risk imported foods* be accompanied by a *credible third-party* certification or other assurance of compliance as a condition of entry into the U.S.) - Voluntary qualified importer program (Voluntary program for importers providing *expedited review and entry* of foods from participating importers - eligibility limited to importers offering food *from certified facilities*) - Authority to deny entry (FDA can *refuse entry* into the U.S. of food from a foreign facility if *FDA is denied access* by the facility or the country in which the facility is located)
Food Safety Modernization Act
- January 2011: Final Rule by President Obama - Created to *ensure* the U.S. food supply is safe - Purpose is to proactively *prevent* contamination rather than federal regulators responding after the fact - *Similar* to HACCP program - *Includes* foods for human and animal consumption (animal feed and allergen)
FDA Applications of HACCP
- Juice products - Fish and Seafood - Retail and Food service products - Dairy products
FSMA: inspection and compliance
- Mandated inspection frequency (Based on *risk*; *High-risk domestic facilities* Must be inspected within five years of enactment - Records access (*Full access* to all records, including safety plans) - Testing by accredited laboratories (*Food testing* must occur at FDA accredited laboratories)
FSMA: response
- Mandatory recall (FDA holds authority to issue a mandatory recall when a company *fails to voluntarily recall unsafe food*) - Expanded administrative detention (FDA has a more flexible standard for administratively detaining products that *are potentially in violation of the law*) - Suspension of registration (FDA can suspend registration of a facility if the food poses *a reasonable probability of serious adverse health consequences* or death - If suspended, the facility can no longer produce its product) - Enhanced product tracing abilities (*Establish a system* that will enhance *tracking and traceability* for both domestic and imported foods; *Establish pilot projects* to effectively *identify recipients of food* to prevent or control a foodborne illness outbreak) - Additional Recordkeeping for High Risk Foods (Establish recordkeeping requirements *for facilities* that manufacture, process, pack, or hold foods that the Secretary designates as *high-risk foods*)
FSMA: preventative controls
- Mandatory written preventive controls for food facilities (Hazard analysis, Critical control points, Monitoring procedures, Corrective action, Record keeping) - Mandatory product safety standards (FDA must establish *science-based, minimum standards* for the safe production and harvesting of fruits and vegetables; both naturally occurring, and hazards introduced during processing) - Authority to prevent *intentional contamination* (FDA must issue regulations to protect against *intentional adulteration* of food)
How will the CCP be Monitored?
- Measurements: critical limits with *numerical values* (temperature, pH, Aw) - Observations (screen in place and intact; Ingredient is added, etc.)
examples of derived critical limits
- Milk pasteurization 161 degrees F/15 sec - Cooking ground beef patties 155F/15 sec - *Cured meat 155 degrees F/Uncured meat 160 degrees F*
HACCP Team
- Multi-Disciplinary - Represent all areas of plant (Engineering, Production, Sanitation, QA; HACCP Skills not Necessary to be on Team) - Outside Experts - Assure proper development - Assist - NOT write
record-keeping procedures: FDA requirements
- Name and location of processor / importer - Date and time of activity - Signature and initials of the operator - Product code, name and identity - Processing data entered when obtained - Reviewer's signature and date of review
types of independent checks
- Periodically measure an *internal cook temperature* with a properly calibrated thermometer - *A second person perform* or observe the same monitoring activity - *Microbial testing* to verify critical limits are met by suppliers
U.S. Army Natick Laboratories: "Modes of Failure Concept"
- Predict *what might go wrong* (a hazard), how, when, and where - *Select points* in the process (critical control points) - an increased probability of a food safety problem if the process is out of control.
revalidation - specific points as warranted
- Prerequisite programs - Raw materials - Equipment - Employee practices - Product formulation - Shelf-life - Packaging - Suppliers - Storage conditions - Preparation / processing practices - Product storage / distribution - Labeling - Emerging food safety hazards - Recalls / product withdrawals - Consumer complaints
Major elements of Food Safety Modernization Act
- Preventative Controls - Inspection and Compliance - Imported Food Safety - Response - Enhanced Partnerships
people responsible for effective monitoring procedures: production - *line supervisors*, selected *line workers*, maintenance, QC
- Proper training - Fully understand the purpose and importance - Capable of making adjustments to maintain control - Unbiased and accurate reporting - Immediate reporting of all deviations
verification of CCPs: *independent check*
- Provides *secondary assurance* that the hazard is being controlled as intended - Check the *method and frequency specified* in HACCP plan - *Records* become part of HACCP plan
Benefits of HACCP
- Reduces the amount of *foodborne illnesses and product* waste - Builds on *Quality Assurance* and Control programs - Incorporates *all levels* of plant personnel: from maintenance to management - Increases *operational efficiency*, profits, and *consumer confidence*
hazard identification
- Review *ingredients*, activities at each step of processing, equipment used, final product, method of storage and distribution, intended use and *consumers*. - *Brain storming* to *identify* biological, chemical and physical hazards that may be introduced, increased or controlled during processing - Epidemiological evidence, risk assessments
problems with noncontinuous effective monitoring procedures
- Seldom tests due to large numbers of samples - Technical limitations in detecting pathogens and toxins - False sense of security
verification procedures:
- Should require minimal end-product testing - Review HACCP plan for scientific and technical accuracy - Are the hazards control appropriate? - Are the CCP's and control strategies appropriate?
FSMA: enhanced partnerships
- State and local capacity building (Implement strategies to enhance food safety and defense capacities of State and local agencies - *offer multi-year grants* to facilitate investment in State capacity to *more efficiently achieve national food safety goals*) - Foreign capacity building (A plan to expand the capacity of foreign governments and their industries - for example, address *training of foreign governments and food producers* on U.S. food safety requirements) - Reliance on inspections by other agencies (FDA relies on inspections of other *Federal, State and local agencies* to meet its increased inspection mandate for domestic facilities; FDA can enter into *interagency agreements for inspection* of seafood facilities, both domestic and foreign, as well as seafood imports)
Re-validation of HACCP plan by HACCP team and independent experts
- System failures - Product formulation/ packaging changes - New hazards - Following HACCP plan - CCP monitoring - Corrective action records
HACCP records: the HACCP plan
- Team members and responsibilities - Description of food, distribution, intended use and consumer - Verified flow diagram
automatic alerts
- Time and temperature thresholds set by user. - Sent to appropriate employee when proper temperatures are reached for each process. - Sent when food temperature falls outside the user-defined acceptable range.
purposes of establishing monitoring procedures
- To *track trends* in the operation which *allows for corrective action* before a deviation occurs - To *determine deviations* at the CCP (exceeding or not meeting a critical limit) - To *provide written documentation* for verification
verification of HACCP plan: on-site audit
- Verifies that *implementation of the HACCP plan complies with* the written HACCP plan - *two major* activities: Review of HACCP records, On-site audit
Regulatory Requirements for Monitoring Meat/Poultry and Seafood
- Written *HACCP plan* must *describe monitoring procedures* and frequency of monitoring - Monitoring information, *date and time* must be *entered in monitoring records* during monitoring - *Person* conducting the monitoring must *sign* or initial each entry on the record sheet
3) supporting documentation
- critical control points: Diagram or flow chart *showing CCPs*, Deliberations in *determining CCPs*, Discussion of *CPs vs. CCPs* - critical limits: *Citations* from scientific literature, government regulations, *Precision and accuracy* of test method - monitoring procedures: *Copies* of all SOPs - normal fluctuation vs. loss of control, *Copies* of all test methods, *Precision and accuracy* of continuous monitoring methods at CCPs
SSOPs are *Tailor-made* for Establishments:
- livestock slaughter/processing - poultry slaughter/processing - import inspection - warehouses
review of HACCP records
- records: *Current HACCP* plan: basis for verification, *Audit reports* of prerequisite programs - *End result*: determines if *the facility has been operating* according to the HACCP plan
Meat Inspection Act
- requires that there be federal inspection at production plants - Administered by *FSIS*: Food Safety Inspection Services of USDA - Domestic market *meats*, later expanded to include *poultry* and *egg* products (not shelled eggs)
HACCP (Hazard Analysis Critical Control Point)
- the most effective system to ensure *food safety* - A methodical and systematic application of *science and technology* to plan, control and document the *safe production* of foods
Top concerns:
-"Presence of": Bacteria, viruses, prions, and parasites -"Growth of": Bacteria -Spore Germination: Followed by toxin production by bacteria -Toxin Production: By non-sporeforming bacteria
corrective action records
-*Accurate record* of all violated product -*Quantity and codes* of all product held, released, destroyed or reworked
Storage of Raw Materials and Ingredients:
-*Bulk containers* designed and constructed to prevent contamination -Held at room temperature/relative humidity -*Frozen materials* kept frozen and thawed before use so as to prevent adulteration -*Re-work material* properly identified
Food-contact surfaces
-*Corrosion-resistant* when in contact with food -Manufactured from *non-toxic materials* -Designed to *withstand the environment* of their intended use in regard to food, *cleaners* and *sanitizers*
*THREE ELEMENTS* OF CORRECTIVE ACTION (NACMCF)
-*Determine and correct* the cause of non-compliance -*Determine the disposition* of the non-compliant product that poses a food safety risk -*Record* the corrective action
reasons for keeping records
-*Documents* procedures and processes in HACCP plan -Adherence to critical limits -Monitoring activities -Regulatory compliance *audits*: compliance with the HACCP plan -Assist in identifying products involved *in recalls*
verification of CCPs: calibration
-*Ensure accuracy* of measurements (Pressure, temperature, time, pH, flow rate, R.H.) -*in the HACCP plan*: Piece of equipment, Calibration frequency, Person responsible -If equipment is *not within tolerance*: *Recalibrated* or replaced, *Review records* back to last acceptable calibration for possible critical limit violations and impact on product safety (impact of calibration frequency)
Production and Process Controls cGMPs
-*Inspection and storage* of raw materials and other ingredients -Inspected for cleanliness -*Segregated* and stored to prevent contamination/deterioration -*Raw materials* washed or cleaned as necessary to remove soil -*Water for washing*, rinsing and conveying must be potable -Inspect raw material containers
Verification (Checking) -
-*Ongoing activities* to demonstrate conformance to the HACCP system -Those activities that determine that *the system is operating according to the plan*
1) summary of the hazard analysis
-*Potential hazards* identified along with the significance and likelihood of occurrence -*Justification* or discussion of *control measures* to prevent, eliminate or reduce the hazard to an acceptable level -*Table format* (hazard analysis form)
corrective action taken will *vary* based on:
-*Processing parameters* -*Type of food* manufactured
Warehousing and Distribution cGMPs
-*Protect final product* from microbial, chemical and physical contamination during storage and distribution -*Protect against deterioration* of the food and container
Monitoring Procedures: Measurements/Observation
-*Real-time* assessment vs. analytical testing -Designed to *detect deviations and alert personnel* to appropriate corrective action -Adequate *training of personnel* for objectivity and accuracy - Best observer
Monitoring Procedures: Measurements
-*Select an appropriate monitoring "device"* (pH paper vs. pH meter) -*Accuracy* (How close a measured value is to the actual true value? -*Precision* (How close the measured values are to each other?) -*Recalibrate the device to ensure accuracy* (verification).
Freezer with cold storage compartments fitted with:
-*Thermometer* or temperature measuring/recording device -*Automatic control* or *alarm system* for maintaining proper temperature
Types of adjustments:
-*Time and temperature* - *pH* - *Reroute ingredients* (moisture/nitrite) not meeting criteria to fully cooked products
Step 5. Resources
-*Updating/adapting* equipment -Monitoring systems -Data storage systems
USDA REGULATORY REQUIREMENTS
-*Written description* of corrective action required in HACCP plan -*Action* taken must ensure that: The *cause of the deviation* is identified and eliminated and The *CCP* is brought *back under control* by the corrective action -Deviation is *prevented from recurring* -*No unsafe product* enters commerce: Segregate and hold, Test for safety -*Determine if* deviation/unforeseen hazard needs to be included *in the HACCP plan* -*Requirements of 9CFR 417.3 must be met*
BSE - Bovine spongiform encephalopathy
-A prion: a modified form of a normal protein -Progressive and fatal neurological disease of cattle, may be related to CJD disease in humans -Source: Infected brain and spinal cord tissue. -Extremely resistant to heat and normal sterilization processes.
in Determining Biological Hazards, consider Characteristics of an organism:
-Ability to grow in food -Ability to survive on food -Infectious dose of organism -Or amount of toxin formed
SSOP's for Meat and Poultry Must include the following:
-All *daily procedures* used before and during operations to prevent direct contamination or adulteration of product -*SSOP's signed and dated* by person with overall authority -Mandatory *minimum pre-operational procedures* that include cleaning of food contact surfaces, equipment and utensils -*Frequency* at which each SSOP is to be conducted and *who is responsible* for completion
Listeria monocytogenes: three alternatives
-Alternative I: includes post lethality treatment AND an antimicrobial agent or process to suppress the growth of LM for duration of product's shelf-life -Alternative II: includes post lethality treatment OR an antimicrobial agent or process to suppress the growth of LM for duration of product's shelf-life -Alternative III: Use of sanitation measures ONLY for control of LM
Purpose of Prerequisite Programs
-Assure the *proper function* of HACCP in producing safe foods -*Simplifies* the development and maintenance of HACCP plan -An essential component of operations
adjusting the process:
-Automatic *in-line monitoring* and control (flow-diversion valves): Pasteurization, In-line fillers, Cookers -*Non-automatic* monitoring and control: *Operator takes action* specified by management
Establishing critical limits:
-Based on aforementioned information -*In-plant research* (ex: Cooling rate to minimize B. cereus growth during processing; Recommended rate vs. other acceptable rates)
"N-60" Sampling Method
-Beef trim combo-bins of 2,000lbs. each are tested individually or in groups of 5 -Forceps and scalpel are used to remove 60 small pieces weighing 6- 7g. each from the carcass surface or from trim combo-bin -Collectively weighs around 375 grams - Tests for E. coli O157:H7 -Product is held until sample test results are completed -If first test is negative: product is safe to ship -If first test is presumptive positive: need a confirmation sample (If second sampling is negative: product is safe to ship, If second sampling is positive again: product is marked for "cooking only" or rendering)
Sources of microbial hazards
-Beef: Salmonella, E. coli O157:H7, C. perfringens -Poultry: Salmonella, Campylobacter; C. perfringens -Vegetables: L. monocytogenes, C. botulinum, Salmonella -Fruits: Salmonella, E. coli O157:H7, -Fish: Vibrio, C. botulinum, parasites, viruses -Eggs: Salmonella -Juice: E. coli O157:H7, Salmonella, Cryptosporidium -Spices: Salmonella, Clostridium -Personnel: Viruses, Staphylococcus -Receiving: Types of raw materials handled -Wet Environment: Listeria Dry -Environment: Salmonella
Shiga Toxin-Producing Escherichia coli (STEC) intervention strategies before and during grinding
-COA from supplier (need to conduct verification). -Treatment of trim. (Hot water, Organic acids (lactic acid, peroxyacetic acid), Combination treatments) -Microbiological testing of lots.
verification records
-Calibration *records to confirm accuracy* of monitoring equipment -Periodic *measurements or observations* for record -HACCP *audit report* from verification
monitoring records: continuous monitoring
-Circular charts (time / temperature) -Electronic (metal detector) -Supplemented by charts, logs, check lists and laboratory data sheets
Step 3. Employee Training
-Continuous education -Must understand importance of assigned duties -*Periodic verification* of employee performance
Validation (Science) -
-Demonstrates that the *HACCP system (as designed)* can adequately control hazards to product a safe, unadulterated products -The collecting and evaluating of *scientific and technical information* to determine if the HACCP plan will effectively control the hazards
chemical hazard control measures: processing
-Direct Food Additives (Prerequisite Programs) -Indirect Food Additives (Prerequisite Programs)
Monitoring Devices
-Direct contact with product can potentially introduce hazards (pH probe: bacteria, Thermometer: mercury, glass, bacteria) -Discard product in direct contact with contaminated device to eliminate any hazard -Frequent cleaning/sanitizing of the device
monitoring records: discontinuous monitoring
-Every sampled lot or test documented -Use standardized forms or log book
Salmonella Performance Standards
-FSIS selected Salmonella as the target organism for which to establish standards in processing facilities -Used as a measure of process effectiveness in controlling contamination by this pathogen in slaughter and raw ground product operations -Establishments and FSIS use a means to check the effectiveness of the HACCP systems
Programs that may be considered as prerequisites:
-Facilities -Production equipment -Raw product control -Sanitation -Chemical control -Production and quality controls -Glass control -Receiving, storage, and distribution -Traceability and recall -Complaint investigations -Labeling -Training
in food chemical hazards: direct processing additives
-Flavor enhancers, color additives, thickeners -Curing ingredients, allergens, stabilizers (Pink Cure (Sodium Nitrite concentration in final product)) -Microbiological processing/packaging aids
chemical hazards - "contains" (included in foods):
-Found in Raw Materials -Direct processing additives (allergens)
Controls - Prevent Growth of Foodborne Disease Agents
-Freezing -Refrigeration -Proper cooling -Hot holding -Decreasing pH -Preservatives -Multiple factors (hurdle technology)
Parasites: examples
-Giardia -Cryptosporidium parvum -Cyclospora
Staphylococcus aureus control
-Good personal hygiene practices: Washing hands, Covering wounds -Proper temperature control of foods: Keep hot foods hot and cold foods cold
HACCP records include...
-HACCP plan -Support documentation (Validation records) -Other records generated by the HACCP plan
Botulism Outbreak in NY, causes & outcomes
-Had *not had an inspector* in the Bon Vivant Plant in 4 years. -Bon Vivant soups *undercooked* and not much in the way of record keeping. -Filed for bankruptcy in a month
Controls - Prevent Contamination of Food:
-Harvesting practice (Shellfish harvest areas) -Growing practices (Fruits and vegetables grown in areas separated from farm animals) -Prevent cross contamination (Separation of raw and cooked foods, Cleaning and sanitizing of shared surfaces)
Critical Limits: HACCP Steps
-Hazard analysis -Identify CCP's -Identify *control measures* -Identify *how/where* control measures *must be applied*
What to assess when validating the HACCP plan
-Hazard analysis (Are all significant hazards identified and properly controlled?) -*CCP's* -*Critical limits* -Monitoring -Corrective action
HACCP Plan summary table (7 steps)
-Hazards of concern - must be prevented, eliminated or reduced to acceptable levels -CCP's - control identified hazards -Critical limits - should be respected to ensure that each CCP is under control -Monitoring - assure that CCP are under control -Corrective Action - when monitoring indicates that a critical control point is not under control -Verification and procedures & schedule - confirm proper functioning of the HACCP system -Record-keeping procedures - organize documents regarding all procedures and records related to these principles and to their application
campylobacter control
-Heat treatment -Intervention strategies to reduce prevalence in raw poultry
control of salmonella species
-Heat treatment (Concern with low Aw products at minimally process temperatures) -Prevention of cross contamination (Air flow/dust control, Residue on equipment) -Reduction on incoming raw materials
Controls - Destroy or Remove Foodborne Disease Agents:
-Heat treatment (time/temperature) -Irradiation -Freezing for parasites -Surface washes (ex. carcass wash) -New technologies (ex. high pressure, pulsed light, etc.)
chemical hazards - "is added" (non-foods):
-Indirect processing additives -Building or equipment maintenance chemicals (Grease, Mineral oil) -Cleaning, sanitizing, or pest control chemicals (Laundry detergent, Highly concentrated sanitizer) -Storage and shipment chemicals
non-food chemical hazards
-Indirect processing additives (Boiler water additives, Peeling aids, Defoaming agents) -Building or equipment maintenance chemicals (Grease, Mineral oil, Paints/Coatings) -Cleaning, sanitizing, or pest control chemicals (Laundry detergent, Highly concentrated sanitizer, Pesticides) -Storage and shipment chemicals (Cross-contamination with various types of chemicals)
Current Good Manufacturing Practices (cGMP's)
-Listed in Code of Federal Regulations (21 CFR 117 Subpart B) -Establish the *conditions and practice* that food industry must follow for safe food production under sanitary conditions
Viruses - Hepatitis A
-Low infective dose ( 10 to 100 virus particles) -Fever, malaise, nausea, abdominal discomfort, jaundice S -pread through personal contact to food or food contact surface -Associated with ready-to-eat foods
Viruses - Norovirus
-Low infective dose ( 10 to 100 virus particles) -Vomiting, diarrhea, and dehydration -Spread through personal contact to food or food contact surface -Associated with ready-to-eat foods, shellfish, and contaminated water
Equipment and Utensils cGMPs
-Manufactured and designed for adequate cleaning -Installed and maintained to *facilitate adequate cleaning* of equipment and surrounding area
Campylobacter
-Mode: Infection -Causes diarrhea (sometimes bloody), cramping, fever, can result in Guillain-Barre syndrome -Infective dose: less than 1,000 organisms -Symptoms last several days to a week -Most common cause of sporadic bacterial enteritis -Cases of illness associated with undercooked poultry and meat, unpasteurized milk, and contaminated water -Microaerophilic (low oxygen) gram negative curved rods; motile -Will not grow below 30ºC; sensitive to drying -No unusual heat resistance -Primary reservoir: Many animals including poultry, cows, pigs, sheep, and wild birds. Also contaminated water and flies. -30% decline observed by FoodNet for Campylobacter (attributed to HACCP, GMPs, and consumer education) -Campylobacter remains a primary agent for sporadic diarrheal foodborne illness in the United States -Campylobacter is reported to be present on 90% of poultry carcasses
Listeria monocytogenes
-Mode: Infection -Causes diarrhea, meningitis, encephalitis, septicemia, miscarriages, stillbirths -Affects high risk groups - Pregnant women, neonates, and immunocompromised adults -Symptoms develop within 3 to 70 days -Transmitted to foods via post process handling, or food is inadequately processed. -Recent issues - Sliced deli meat and other RTE meats, hot dogs, cheese, ice cream, coleslaw and cantaloupes -Gram positive, non-spore forming, facultative, motile rod -Associated with animals, soil, water, food plants (cold and moist areas) -Growth and survival (Low Temperature - growth as low as 0ºC, and can survive freezing; pH - growth down to 5.6*, and may survive below 4.3 ;Aw - growth down to 0.93, can survive to 0.83; High temperature - inactivated at temperatures above 50ºC* (D-values at 160ºF - up to 5 seconds))
Salmonella species
-Mode: Infection -Causes severe diarrhea with fever, vomiting, and dehydration -Infective dose: as few as 20 cells to 10,000 -Onset usually 12 to 14 hours -Symptoms last 2 to 3 days (can get reactive arthritis 2 to 3 months later) -Cases of illness associated with undercooked meat and poultry, eggs, cereal, pet food, peanut butter, produce (tomatoes, peppers) -Facultative anaerobe, gram negative rods -Optimal growth 37ºC and pH 6.5 to 7.8, but can grow as low as 2 to 4ºC and up to 54ºC, and pH from 4.5 to 9.5* -Primary reservoir: Intestinal tract of animals -Incoming animals and animal products including eggs, contaminated produce, nuts, and grains, insects, birds -Can survive in dry foods and refrigerated foods for prolonged periods of time
Clostridium botulinum
-Mode: Intoxication -Causes paralysis, blurred vision, death -Symptoms start to develop within hours -Organism grows to large numbers in food where it produces toxin. The toxin is ingested and affects neurological system. -Associated foods: improperly processed canned foods, honey, garlic-in-oil mixtures, temperature abused foods (cooked potatoes, stews, etc) -Gram positive, spore forming, anaerobic rod -Proteolytic strains: spores can survive temperatures over 110ºC, but do not grow below 12.5ºC -Non-proteolytic strains: spores can survive temperatures up to 82ºC, but can grow down to 3.3ºC -pH: growth minimum pH 4.7 -Found in soil and water
Staphylococcus aureus
-Mode: Intoxication -Causes vomiting, nausea, and abdominal cramps -Symptoms develop within 4 hours of ingestion and last 24 to 48 hours -Transmitted to foods via post process handling: organism grows on a temperature abused food item and produces a heat-stable toxin. The ingested toxin causes the illness. -Recent issues: batter, cooked chicken, canned mushrooms, cream filled pastries -Gram positive cocci that grow under aerobic and anaerobic conditions -While organism can grow as low as 6.7ºC, optimal growth and toxin production occurs between 40 and 45ºC -Toxin is heat stable Salt tolerant (up to 20%) and can grow at Aw as low as 0.84 -Primary reservoir - Animals including humans (skin, hair, nose, open sores, boils, saliva)
Clostridium perfringens
-Mode: Toxin mediated infection -Causes diarrhea, severe dehydration, cramps -Symptoms develop within 8 to 22 hours -Organism grows to large numbers in food (108), organisms are ingested, and then produce toxin in intestine -Associated foods: temperature abused foods, roast beef, stews, meat gravy, poultry -Gram positive, spore forming, anaerobic rod -Heat resistance: spores can survive boiling -Found in soil, intestinal tracts of animals
Shiga Toxin-Producing Escherichia coli (STEC)
-Mode: Toxin mediated infection -Causes severe bloody diarrhea, cramping, fever, and can lead to HUS Infective dose - as few as 10 cells -Onset usually 4 to 10 days -Symptoms last 4 to 14days (6% lead to HUS with half of that requiring dialysis, fatality ~1%) -Cases of illness associated with undercooked beef, spinach, sprouts, cookie dough -Shiga toxin-producing Escherichia coli, a type of enterohemorrhagic E. coli (EHEC) bacteria -Includes serotype E. coli O157:H7, and 6 other non-O157 strains O26, O45, O103, O111, O121, and O145. -Facultative anaerobe, gram negative rods -Acid tolerant - growth down to pH 4.0 to 4.5 -No unusual heat resistance (D value of 9.6s at 64.3ºC) -Primary reservoir - Intestinal tract of cattle, as well as sheep and goats. -Seasonal pattern of outbreaks during warmer months.
*Dried and intermediate moisture foods* maintained at a safe moisture level by:
-Monitoring aw -Controlling soluble solids-water ratio in final product -Barriers against moisture pickup
Mold
-Multicellular fungi - form mycelium -Grow over a wide pH range (below 1 to 11) -Grow at low Aw (as low as 0.6) -Some species produce mycotoxins
FDA REGULATORY REQUIREMENTS
-Must either follow a *corrective action plan* or *segregate and hold the product* for evaluation - *Written* corrective action plans *NOT required* in HACCP plan -Corrective action plan: Ensures that *no unsafe product* enters commerce and Ensures that the *cause of the deviation* is corrected - Assess *potential modification* of HACCP plan - *Corrective action records* must fully *document* the actions taken
in Determining Biological Hazards, consider Characteristics of the Food:
-Need to determine whether certain microorganisms can grow in a food (or survive even if conditions don't favor growth). -Antimicrobials inherent in the food may inhibit growth and/or survival. -Hurdle Effect: the combination of factors (such as temperature and moisture) may work together to inhibit growth
with documentation (written prerequisite plan), Include standard operating procedures (SOP's):
-Objectives -Procedures -Practices -Job description/requirements
areas that Current Good Manufacturing Practices (cGMP's) are needed in:
-Personnel -Ground, building and Facilities -Equipment and Utensils -Production and Process Controls -Manufacturing Operations -Warehousing and Distribution
chemical hazard control measures: raw materials
-Plant/Animal Foods (Good Agricultural Practices, Purchase Specifications, National Residue Program, Total Diet Study) -Packaging Materials (Purchase Specifications)
HOW TO PREVENT PHYSICAL HAZARDS
-Prerequisite programs -Good Manufacturing Practices -Paperwork -Observation (Visual inspection) -Detection equipment (Metal detector, X-ray equipment, UV-Light equipment) -Sorting equipment (Screen or sifter) -Removal procedures and/or equipment (Bone separator)
BSE - Bovine spongiform encephalopathy control
-Prevent importation of high risk animals and products. -Prohibit feeding of mammalian protein to ruminants. -Surveillance and quarantine suspected infected animals -Control of Specified Risk Material (SRM) -Control of cattle greater than 30 months of age -Control of non-ambulatory cattle.
Meeting Alternatives for Listeria Control
-Processing: Post packaging heat treatment -Formulation changes: Product characteristics (fermented, nitrites, high salt, low water activity), Chemical agents (organic acids, allyl isothiocyanate, etc), Biological agents (live cultures, bacteriocins) -Packaging: Incorporation of antimicrobials -Sanitizers in the post-process environment -Plant sanitation to prevent harborage sites and points for cross contamination with specific attention to biofilms -Prevent entry through people, materials, and equipment -Monitoring of environment -Proper temperature control of foods -Temperature and moisture control in environment
The Jungle
-Published in *1906* -Written to expose the appalling working conditions in the *Chicago Meat Packing Industry* -*Mr. Sinclair's* descriptions of diseased, rotten, contaminated meat and gross insanitary conditions shocked the public
Production and Process Controls cover
-Raw Materials and Ingredients Containing *Natural Toxins* (i.e. Aflatoxin) -Raw Materials and Ingredients Containing Natural or *Unavoidable Defects* (i.e. Pests, Extraneous Material)
Hold perishable foods to *prevent adulteration*:
-Refrigerated foods: < 41°F -Frozen foods: keep frozen -Hot foods: > 140°F -Heat treating acid/ acidified foods to destroy mesophilic organisms when the product is to be stored anaerobically at ambient temperatures
lawsuits due to physical hazards
-Restaurant sued after woman bites into olive pit: settled for $100,000 -Supermarket sued for serving a rock in a salad: plaintiff awarded $65,000
record review:
-Reviewed by a *designated* HACCP-trained *individual* -Frequency of review (*USDA/FSIS*: reviewed prior to shipping product, *FDA*: seafood HACCP records reviewed within 1 week) -Review of records is the *final control measure* for assuring product safety
organisms of concern in pork
-Salmonella -C. perfringens -T. spiralis -Y. enterocolitica
organisms of concern in fruits
-Salmonella -E. coli O157:H7 -Cyclospora -L. monocytogenes -Norovirus
organisms of concern in vegetables
-Salmonella -E. coli O157:H7 -L. monocytogenes -C. botulinum -Norovirus
organisms of concern in poultry
-Salmonella -Campylobacter -C. perfringens -T. gondii
organisms of concern in milk/dairy
-Salmonella -Campylobacter -L. monocytogenes -Y. enterocolitica
organisms of concern in beef
-Salmonella (Raw) -E. coli O157:H7 (Raw) -C. perfringens (Cooling) -L. monocytogenes (RTE products)
personnel - education and training
-Sanitation/personal hygiene -Food handling techniques -Food protection principles
Top CCPs addressed by McDonalds & CSU
-Skinning -Eviscerating -Final Washing -Chilling and Fabricating -Storing and Distribution
HACCP plan includes...
-Team members and responsibilities -Description of food, distribution, intended use and consumer -Verified flow diagram
2) the HACCP plan
-The written document that *outlines the formal procedures* to be followed in accordance with the *7 principles* of HACCP -Supporting documents: Appropriate HACCP *test methods*, *SOPs / GMPs*, Sample HACCP *records*
in food chemical hazards: found in raw materials
-Toxins, heavy metals, allergens (Common in marine fish) -Antibiotics, hormones, pesticides (Common in market animals, reason for weaning period before harvest) -Packaging materials
retention of records:
-USDA/FDA requirements similar: *1 year*: slaughter activities and refrigerated foods, *2 years*: frozen, preserved and shelf-stable foods
Step 4. Verification
-Verify all SOP's related to every prerequisite program -Conducted by *someone other than* the person assigned to complete the task -Appropriate monitoring and record-keeping
organisms of concern in fish & seafood
-Vibrio spp. -C. botulinum -Viruses -Helminths -Norovirus
Monitoring Activities at CCP's
-Visual observations -Measurements of parameters (Time, Temperature, pH, Etc.)
Step 2. Documentation for compliance
-What procedures are performed? -How often? -By whom? -Action if procedures are not performed as written? -Action if procedures do not produce the expected outcome?
Personnel cGMPs
-disease control -cleanliness -education and training -supervision
how to kill/injure biological hazards
-heat (Hot water, steam vacuuming, steam pasteurization) -pH (Low pH (Acidic): Use of an organic acid application like Acetic acid, lactic acid, mixtures; High pH (Basic): Use of a basic application like Trisodium phosphate) -oxidation (Chlorox, Purex, chlorine based products) -others (irradiation, ultraviolet light, high pressure)
Step 1. Commitment from management
-time -resources
moisture: yeast
.88-.8
moisture: bacteria
.95-.88
NASA's two concerns about space food:
1) *Crumbs and water droplets* in zero gravity with electrical equipment (Bite-sized foods and edible coatings to hold foods, Special packaging to minimize exposure of foods) 2) *Microbiological safety*: foods are free from pathogens, parasites and biological toxins
four types of HACCP records
1) Summary of the hazard analysis 2) The HACCP plan 3) Supporting documentation 4) Daily operational records
_________ deaths due to foodborne illness
1,351
Beef Jerky Thermal Processing reduction of lethality is likely due to 2 reasons:
1. *Evaporative cooling* on the surface of the beef strip keeps it from getting hot enough 2. *Early stages in heating* may make the pathogens *more heat-resistant* so that they survive the *later stages* of the process
3 principles of the original HACCP system
1. *Identify and assess hazards* potential hazards throughout growing, harvesting, and processing 2. *Determine critical control points* (CCPs) to control any identified hazard 3. *Establish systems to monitor* all identified CCPs
*seven principles of HACCP*
1. Conduct a Hazard Analysis 2. Determine the Critical Control Points (CCPs) 3. Establish Critical Limits 4. Establish Monitoring procedures 5. Establish Corrective Actions 6. Establish Verification procedures 7. Establish Record-Keeping and Documentation procedures
four essential elements listed:
1. Plant's use of Sanitation Standard Operating Procedures (*SSOPs*) 2. *Adopt HACCP* as a system of process controls to limit food safety hazards 3. *Meet Pathogen Reduction Performance* Standards set by FSIS-USDA 4. Conduct *tests for Generic E. coli* to verify the plant's control system prevents fecal contamination
Four Steps in Establishing Monitoring Procedures
1. What attribute will be monitored at the CCP to control the identified hazard 2. How will the attribute be monitored (Procedures) 3. When will it be monitored? (frequency) 4. Who will perform the monitoring procedures?
two stages of hazard analysis
1. hazard identification 2. hazard evaluation
FSIS specially required that establishments develop HACCP plans that fall into the *nine processing categories*:
1. slaughter - all species 2. Raw product - ground 3. Raw product - not ground 4. Thermally processed - commercially sterile 5. Not heat treated - shelf stable 6. Heat treated - shelf stable 7. Fully cooked - not shelf stable 8. Heat treated but not fully cooked - not shelf stable 9. Product with secondary inhibitors - not shelf stable
operating limit example: In hot dog production, an operating limit of 170*F was established for the internal product temperature - This is...
10 degree above control limit of 160*F Throughout the day, an occasional 168*F is measured, however product does not need to be placed on hold because it is well above the critical limit
The *critical limit* for cooking chicken is 165F. It was found that the product had better sensory scores when heated to 172F. Therefore the *operating limit* was set at...
172F
Botulism Outbreak
1971 - A deadly outbreak of botulism linked to Bon Vivant's cold potato soup (Westchester, New York). *New York man had died* and his wife has become seriously ill from botulism
The original HACCP system
1971 National Conference on *Food Protection* in Denver: *HACCP was first presented* to an audience beyond NASA
Jack in the Box outbreak
1993: *Hamburgers contaminated with E. coli* O157:H7 infected over 700 people, killing 4 children and leaving over 100 with permanent kidney and brain damage
Performance standards for whole chickens have been in place since...
1996
Incidents/illnesses caused by physical hazards:
2%
how long does it take for bacteria populations to double
20 minutes
claims due to physical hazards
2007: McDonald's processed over 4,500 claims because of physical hazards -90% ended up being fraudulent -800 cases settled out of court
______ known agents of foodborne disease
31
Incidents/illnesses caused by chemical hazards:
4%
Temp danger zone
40-140
danger zone
40-140 degrees Fahrenheit-- optimal temperature for microbial growth
__________ hospitalizations due to foodborne illness
55,961
_____ million illnesses
9.4
Incidents/illnesses caused by biological hazards:
94%
moisture: mold
<.8
Critical Limits Codex definition
A criterion that *separates acceptability from unacceptability*
Critical Limits FDA definition
A maximum and/or minimum value (not an average) to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce the occurrence of the food safety hazard to an acceptable level
HACCP Principle 4: Establish Monitoring Procedures
A planned *sequence of observations* or measurements that are recorded to determine if a *CCP is under control*
HACCP Principle 2: Determine Critical Control Points (CCP's)
A step at which *control is essential* to either prevent / eliminate the hazard to reduce the hazard to an acceptable level
Critical Control Points (CCP)
A step at which control can be applied and is essential to *prevent or eliminate* a food safety hazard, or *reduce* it to an acceptable level
Decision Trees (NACMCF and Codex) are...
A useful tool in determining CCP's
Some Cleaners Used in the Industry:
A. Chlorine containing compounds (Na or Ca-hypochlorite, Gaseous Cl) B. Aldehydes (Formaldehyde, Phenols, Alcohols, Acids) C. Quaternary ammonium compounds (QUATS; Not corrosive but low efficient on spores) D. Oxygen-releasing substances (Peroxide compounds, Per-acetic acid)
physical hazards
Added foreign material introduced into the food product
Personnel - Disease control -
Any person who by medical exam or supervisory observation is *deemed ill or infected* shall be excluded from handling food
Control Point (CP)
Any step at which a biological, physical, or chemical factors can be controlled
prevent-reduce-eliminate
Attempts to assure food safety depends on the effort to *prevent, reduce, or eliminate* all biological hazards to an acceptable level
Other Common Bacterial Pathogens
Bacillus cereus Vibrio spp. Yersinia enterocolitica Shigella ssp. Aeromonas hydrophila
Jack in the Box outbreak cause
Believed to be caused by *meat being contaminated by fecal material* on the harvest floor
reduce
Biological hazards to an acceptable level (By killing; minimizing growth, outgrowth, and toxin production)
National Residue Program (FSIS - USDA)
Collects and analyzes domestic and imported meat, poultry, and egg products for chemical residues of veterinary drugs, pesticides, and environmental contaminants (ex: KIS test)
When will the CCP be monitored?
Conducted *sufficiently often* to: -Detect when a deviation has occurred -Prevent such foods from reaching consumers
effective monitoring procedures are...
Continuous and rapid (preferred) - *chemical and physical* methods [biological methods often too slow: exceptions - ATP assay]
Clostridium perfringens control
Cool foods rapidly after heating
Critical Limits FSIS definition
Critical Limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirements set forth, are met
records
Dated and signed by the person doing the monitoring
Meat (HACCP definition)
Defined in 9 CFR 301.2 as the part of the muscle of any cattle, sheep, swine, or goats which is skeletal
Poultry (HACCP definition)
Defined in 9 CFR 381.1 as any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs, also termed young pigeons from one to about thirty days of age), whether live or dead.
Egg Product (HACCP definition)
Defined in 9 CFR 590.5 as any dried, frozen, or liquid eggs, with or without added ingredients...
purpose of validation
Determine if the HACCP system is actually controlling the identified hazards
purpose of verification
Determine if the HACCP system is functioning according to the plan
HACCP Principle 1: Conduct a Hazard Analysis
Develop a list of *biological, chemical and physical hazards* that are: Reasonably likely to occur, Reasonably likely to cause injury or illness if not effectively controlled
National Residue Program consists of...
Domestic (scheduled & inspector generated) and Import Re-inspection Sampling Plans
prevent
Effort to prevent any biological hazard contamination or growth throughout processing: farm to fork
likelihood of occurrence examples
Epidemiological data, literature, impact of food preparation method, transportation, storage, *target population*
Manufacturing operations cGMPs
Equipment, utensils and food containers properly maintained by cleaning / sanitizing
chemical adulteration/hazards
FDA Definition: A food is "chemically adulterated" if: (a) the raw material contains a poisonous, deleterious, or injurious substance (b) if such substance is added during production, processing, or preparation of the food product
FATTOM (the six favorable conditions required for the growth of foodborne pathogens)
Food, Acidity, Temperature, Time, Oxygen, Moisture
most common physical hazards
Glass, Wood, Stones, Metal, Jewelry, Bone, Plastic, Insulation, Bullets/BB shot, Needles
control of viruses
Good Personal Hygiene Proper Handwashing Wearing gloves Policy for employees to report health issues
Listeria monocytogenes: RTE products which are post-lethality exposed must control Listeria monocytogenes through...
HACCP or other prerequisite programs
how many CCPs are needed?
HACCP plan can be modified; Number and location of CCP's *frequently changed* during HACCP plan development and implementation
HACCP Principle 7: Establish Record - Keeping and Documentation Procedures
HACCP records: Hazard analysis summary - rationale for hazards and control measures
*Too many CCPs* will over burden the...
HACCP with non- safety issues
Purpose of determining critical control points
Hazards *reasonably likely to cause* injury or illness in absence of control must be addressed
Escherichia coli O157:H7 Intervention strategies on farm and pre-slaughter:
Housing, feed, and water Antibiotics Vaccine Probiotics/ competitive exclusion Chemical Transportation Holding pens Cattle cleanliness
reviewers of record-keeping and documentation
In-house, outside consultants, customers, regulators
NACMCF also altered...
Inspector's roles in the plant too
*Inline pH measurement* improves consistent grade of end products:
Measuring pH inline has tremendous benefits such as a more reliable *live measurement*, ability to *control the process instantly*, and the *labor savings* alone can yield an immediate return on investment.
in 1906, Congress passed...
Meat Inspection Act and Food & Drug Act
biological hazards:
Microorganisms such as bacteria, viruses, yeasts, molds and parasites; Some of the hazards are pathogenic and/or produce toxins
Who will monitor the CCP?
Monitoring personnel • *Operations staff (line supervisor or selected line worker)*: Best qualified to detect deviations and take corrective actions
Microbial Contamination of Raw Materials and Ingredients
Must be either (a) *free of microorganisms* that can cause foodborne diseases in humans of or (b) *treated* to reduce any risk to an acceptable level
______________________ equipment in food manufacturing area must be kept clean
Non-food contact
top eight pathogens (Caused 89% of Single-Etiology outbreaks):
Norovirus 39% Salmonella 26% STEC 6% Scrombrotoxin 5% Clostridium perfringens 5% Staphylococcus enterotoxin 3% Ciguatoxin 3% Campylobacter jejuni 2%
Critical Limits NACMCF definition
One or more prescribed tolerances that must be met to ensure that the CCP effectively controls the biological, chemical or physical hazard (NACMCF)
eliminate
Only possible through a "Kill Step"; Biological hazards present in foods are removed
Production and Process Controls
Overview: Required for all operations in *receiving*, transporting, segregating, preparing, manufacturing, packaging and *storing* of food
Based on _______________ rather than inspection
PREVENTION
FDA's 8 Common Allergens (US)
Peanuts, Tree nuts, Eggs, Milk/Dairy, Soy, Wheat, Fish, Shellfish
Government-established food safety criteria
Performance standards (regulatory standards or guidelines) • *Milk pasteurization*: (161°F/15 sec) • *Low-acid canned food*: 12-D reduction (Bot Cook) • Scientifically validated • Data is verifiable ("Science-based")
foodborne intoxication
Person consumes a food that *contains a toxin* produced by bacteria (botulinum toxin or staphylococcal enterotoxin) or *naturally found in some plants* (poisonous mushrooms) or molds (mycotoxin)
foodborne infection
Person consumes a food that contains a *bacteria, virus, prion, or parasite* then multiplies in the body and causes illness
indirect measurement example
Practical dwell time and cooking of temperature
Ice Contacting Food
Prepared from *potable water* according to cGMP's
purpose of establishing corrective actions
Prevent potentially hazardous foods from reaching consumers
*seven principles of HACCP (more elaborate)*
Principle 1 - Identify any hazards that must be *prevented, eliminated or reduced* to acceptable levels Principle 2 - Identify the critical control points (CCP) to *control identified hazards* Principle 3 - Establish critical limits that should be respected to ensure that *each CCP is under control* Principle 4 - Establish a monitoring system to assure that *CCP are under control* Principle 5 - Establish corrective actions when monitoring indicates that a *critical control point is not under control* Principle 6 - Establish verification procedures that *confirm proper functioning* of the HACCP system Principle 7 - Organize documents regarding *all procedures and records* related to these principles and to their application
prions
Prions are thought to be the cause of a group of diseases called transmissible spongiform encephalopathies/BSE
Corrective action: Definition (NACMCF)
Procedures followed when a *deviation occurs*
HACCP Principle 5: Establish Corrective Actions
Procedures followed when deviation occur
Prerequisite Programs to HACCP - Foundational Programs
Procedures, including *Good Manufacturing Practices*, that provide *environmental and operational conditions* (foundation for the HACCP system).
Common Bacterial Pathogens in Food (emphasis on food processing)
Salmonella Shiga Toxin producing E. coli (O157:H7 and other STECs) Listeria monocytogenes Campylobacter Staphylococcus Clostridium perfringens Clostridium botulinum
How will the CCP be monitored?
Sampling and Testing Procedures (*Rarely appropriate* for microbial hazards)
verification examples
Sampling, Calibration Direct observation of monitoring Records review
____________ on food-contact surfaces must be smooth bonded
Seams
*Protection against metal* and other extraneous material in food with...
Sieves, magnets, metal detectors
Listeria monocytogenes: Post-lethality exposed product is RTE product that has the potential to be contaminated in that it comes into direct contact with a food contact surface and/or is exposed to environment after the lethality treatment and prior to packaging; ex:
Slicing, peeling, re-packaging, cooling in brine
hazard:
Something that would contaminate and/or adulterate the final product causing the food product to be unsafe for human consumption
HACCP DEVIATION RECORDS
Standard production form: - Hold number - Deviation - Reason for hold - Number of containers held - Date of hold - Date and code of product held
Five Steps to Establishing Prerequisite Programs
Step 1. Commitment from management Step 2. Documentation for compliance Step 3. Employee Training Step 4. Verification Step 5. Resources
Definition of HACCP
Systematic approach to the identification, evaluation and control of *food safety hazards*
Corrective Actions
Taken when *SSOP fails* to prevent product contamination or adulteration
HACCP System or Program:
The *result* of implementing the HACCP Plan
HACCP Plan:
The *written document* that delineates the procedures to be followed
KIS test
The Charm KIS™ test for kidney is an antibiotic detection test for kidney. tissue. Its principle of detection is microbial inhibition
Low-Temperature Cooking of Summer Sausage and Pepperoni summary
The increased acid in *fermented products increases the effective kill*
HACCP Principle 3: Establishing Critical Limits
The maximum and/or minimum value to which a biological, chemical or physical hazard must be controlled at a CCP to prevent, eliminate or reduce the hazard to an acceptable level of occurrence
log phase of bacterial growth curve
The period of exponential growth of bacterial population; bacteria starts to grow exponentially because its in right temp or found food
4) daily operational records
Three basic types of records: -Monitoring Records( Continuous and Discontinuous) -Corrective Action -Verification
specified risk materials (SRMs)
Tissues in cattle that are considered to be of high *risk* for prion contamination
purpose of establishing critical limits
To distinguish between *safe operating* conditions and *unsafe deviations* at a CCP
Verification (checking) - purpose
To ensure that the *HACCP* plan is being implemented properly - *ongoing activities*
Development, implementation and maintenance of *written SSOP's* mandated by...
USDA
In 1862, Abraham Lincoln founded...
United States Department of Agriculture (USDA)
validation vs verification vs calibration
Validation - science Verification - checking Calibration - accuracy
HACCP Principle 6: Establish Verification Procedures - *validation*:
Validation: "the element of verification focused on *collecting and evaluating* scientific and technical information to *determine* if the *HACCP plan*, when properly implemented, will effectively *control the hazards*"
chemical hazard control measures: storage/shipping
Various cross-contaminants (Prerequisite Programs)
chemical hazard control measures: building/equipment maintenance
Various kinds of Prerequisite Programs
chemical hazard control measures: cleaning/sanitizing/pest control
Various kinds of Prerequisite Programs
HACCP Principle 6: Establish Verification Procedures - *verification*:
Verification: Those activities other than monitoring that *determine the validity of and compliance with the HACCP plan*. These include verification of prerequisite programs, verification of the critical control points, and verification of the overall HACCP plan.
*potable water*
Water that meets the standards for drinking purpose (40 CFR 141)
Beef Jerky Thermal Processing
Whole muscle jerky is intended to be a dry product with desirable texture and shelf-stability. Yet, the drying of the *product may reduce the lethality* of the process and not adequately kill pathogens on the surface.
personnel - cleanliness
Workers who are in direct contact with food, food-contact surfaces and food- packaging materials will maintain *proper hygienic practices*
A single HACCP plan can be established for ...
a *single product* that passes through multiple processing categories
inspectors went from being a command & control regulator to...
a Performance Standard Monitor
Production and Process Controls *must comply with current FDA regulations*, guidelines and...
action levels for poisonous and deleterious substances
*Proper disposal or reprocessing* of...
adulterated foods / ingredients
SSOPs have an Emphasis on *preventing*...
adulteration, contamination and cross-contamination
Sanitation and Standard Operating Procedures
also known as SSOPs; documented steps which must be followed in the food industry to ensure proper cleaning of product contact and non-contact surfaces
Critical Limits are a *specific value*, not..
an average
Approximately 120 chemical compounds across roughly 20 compound classes are quantified by the National Residue Program, examples:
antibiotics, sulfonamides, growth promoters, medication, heavy metals, etc.
death phase of bacterial growth
as resources become insufficient, bacteria die off; they die from the toxins they produce during stationary phase and the lack of food left for them to consume
Operating Limits that are in excess of control limits will help to...
avoid routine violations of critical limits
Provide evidence that the HACCP plan is...
being followed
Problem with numbering CCPs: numbering can cause *confusion* if HACCP plan requires...
changing
top 5 food-germ pairs causing outbreaks in 2015
ciguatoxin, scombroid toxin/histamine, salmonella in chicken, salmonella in pork, campylobacter
HACCP as a combined system:
combined system of *science and technology* to produce safe food products
personnel - supervision
competent supervisory personnel responsible for *enforcing personnel* cGMP's
biological hazards are the largest...
concern for the food industry
Parasites: sources
contaminated water or foods that have come in contact with contaminated water, employees with organism
Equipment, containers, and utensils used to convey food properly constructed, maintained and handled to prevent...
contamination
Two Types of Monitoring
continuous and discontinuous
*Too few CCPs* will not permit adequate...
control of the hazards
Records are the *proof* that a CCP was *controlled* or that...
corrective actions were taken
Monitoring Critical Control Points is *a key element* in...
determining if critical limits are being met
*Potentially different hazards* for the same product based on facilities or processes, such as...
different person, location, equipment
*Manufacturing steps* (e.g., washing, peeling, extruding, cutting, drying, whipping) accomplished so as *to prevent contamination* by...
dripping or draining
*Decrease CCP's*:
eliminate non-safety issues and hazards that are NOT reasonably likely to occur
Biological CCP's are not needed for *acid and low-acid canned foods* which are regulated under...
existing canning regulations
Clostridium botulinum symptoms
food poisoning; weakness, trouble seeing, feeling tired, trouble speaking, weakness of the arms, chest muscles, and legs
benefits of record-keeping and documentation
food safety, equipment performance (*prevent deviations*)
*Compressed air or other gases* introduced into foods or used to clean...
food-contact surfaces or equipment treated to prevent contamination
One of the *most common CCP's* is the use of a *heat treatment* for products in the:
heat-treated, shelf-stable; heat-treated, not shelf-stable; and not fully cooked, not shelf-stable categories.
*heat penetration*
heating/cooling rate
Identify where and how (hazard analysis) a food safety problem may occur in...
ingredients, product, processing, storage, and shipment
*Never erase* data - use...
ink
lag phase of bacterial growth curve
intense activity preparing for population growth, but no increase in population WE TRY TO KEEP BACTERIA HERE!
Growth stages of bacteria
lag phase, log phase, stationary phase, death phase
Failure to comply with SSOP's can lead to...
legal or criminal action
Control addition of acid and amount of acidified ingredients added to...
low-acid food
biological hazards are the hardest to...
maintain control over
*Operational sanitation* procedures are *written procedures* for...
maintaining sanitation during product preparation, storage and handling
SSOPs are An *essential prerequisite* program for HACCP because they Helps assure production of wholesome, unadulterated food, Enhances product quality, shelf-life and operational efficiency, and reduces...
maintenance costs
HACCP as a management system:
management system (*prevention of hazards*) to ensure the production of safe food products
Meat and Poultry Products (9 CFR 308 and 381) Mandates *continuous inspection* of all...
meat and poultry slaughter operations by USDA
direct measurement example
meat thermometer for internal temperature
acidity
microbial growth can happen 4.6-7.5 pH
Beef patties: monitor internal cook temperature vs....
monitoring the cooking process (time in oven/patty thickness)
the idea of HACCP is to cover all types of food safety hazards (biological, physical, and/or chemical) - whether they are...
naturally occurring in the food or present in the surrounding environment
stationary phase of bacterial growth
new cells are produced at the same rate as the old cells die, leaving the number of live cells constant the bacteria have reached their maximum population that can be supported; also they produce some toxins in high numbers
*Determination* of CCP based on the *hazards and control measures* identified during hazards analysis; Each hazard must be controlled at...
one or more CCP's
operating limits are set by the processing plant based upon...
operating data
Unnumbered CCPs: use names such as...
oven, pasteurizer, packaging, etc.
operating limits
parameters more stringent than those necessary for safety and are established for reasons other than food safety
14 common allergens (Europe)
peanuts, tree nuts, eggs, milk/dairy, soybeans, fish, crustaceans (lobster, crab, shrimp), mollusks (oyster, snail, dam, squid), mustard, celery, lupin, sulfites, sesame, cereals containing gluten
*Continually monitor* the process vs...
periodic checks of product temperature
*Adequate data* is needed to support the...
prediction under adequate control and process steps Process validation
HACCP is a common sense approach based on...
prevention rather than inspection
Allergenic substance control in food establishments is important in...
product formulations and to prevent cross- contamination.
CCP Number depends on:
product, ingredients, processing methods and prerequisite programs
Records must include...
production lot, product code, product name, and identity
Clostridium botulinum control
proper processing, proper cold
Operating Limits that exceed Control Limits may be important for...
quality reasons
Monitor pH of...
raw materials, food in process and final product
Protect finished product from contamination by...
raw materials, other ingredients and refuse
• HACCP monitoring must provide...
real-time data
Must *complete hazard analysis* first to endure that the hazards being assessed are...
reasonably *likely to cause illness* or injury
operating limits exceed...
regulatory requirements and recommendations
establishing critical limits is Scientifically based and derived from...
regulatory standards / guidelines, literature, experimental results or experts
top 5 food-germ pairs causing outbreak-associated illnesses in 2015
salmonella in seeded vegetables, salmonella in pork, salmonella in vegetable row crops, norovirus, clostridium perfringens
Alternative level affects...
sampling requirements and USDA involvement
Holding, conveying and manufacturing systems designed and constructed for...
sanitary maintenance
Example of critical limits: An established time/temperature cook of 165F for 15 seconds to eliminate enteropathogens. If the plant wants to establish a critical limit of 158F for 2 minutes, then...
scientific studies will be needed
*Pre-operational sanitation* Ensures that facilities, *equipment and utensils are free from...*
soil, tissue debris, chemicals and other hazards before starting
In 1959 *Pillsbury* worked with US Army to create...
space foods for NASA (the manned space program)
*Increase CCP's*:
specific hazards overlooked
Facility Construction and Design:
suitable in size, construction and design to facilitate maintenance and *sanitary operation*
HACCP is Based on *common-sense* application of _____________ and ____________ principles to the production process from "farm-to-fork"
technical and scientific
Critical limits established by...
tests and experiments (heat penetration, temperature distribution, thermal death, Inoculated pack/microbial challenge studies)
FDA and USDA Require the *development of CCP's* for each hazard identified in...
the hazard analysis
Critical limits must *satisfy the capabilities* of...
the manufacturer
Purpose of HACCP is to potentially limit all contact of any hazard throughout...
the production process
USDA is responsible for...
the safety of meat, poultry, and egg products (*Inspection services, Survey of commodities, Research*)
Thermal death
time for specific pathogens (D-values)
examples of effective monitoring procedures
time, temperature, pH, sanitizer concentration, biosensors
severity examples
type of illness, duration, exposure (short and long term), complications
Parasites: control
use of potable water, good personal hygiene
Post-lethality and antimicrobial treatments must be...
validated
A corrective action consists of:
• *Acting immediately* to prevent adulterated product from entering commerce • *Identifying and eliminating* the cause of the deviation • *Bringing the CCP* under control • Establishing measures to *prevent recurrence* of the deviation
*Regulatory consideration* for critical limits:
• *Addressed by* both FDA and USDA • Critical limits *must be listed* for each CCP • USDA critical limits designed *to meet USDA-established targets*, performance standards and other requirements • *Less stringent critical limits* must be supported with sound scientific data
Person responsible for monitoring:
• *Designated* in the HACCP plan by job title • *Signs or initials* the monitoring records • *Not by name* since the person will not always be present - illness, vacation, etc.
Basic Steps
• *Determine food safety parameter* (time, temperature, pH, flow rate, etc.) that must be met at each CCP • *Determine proper standard* that will prevent eliminate or reduce the occurrence of the food safety hazard to an acceptable level
Corrective action For deviations for SSOP's:
• *Develop procedures* for employees and management to fix it. • *Document* corrective action.
Implementation and Monitoring - Develop procedures for assessing SSOP effectiveness:
• *Organoleptic / sensory*: sight, feel smell • Chemical: sanitizer level • *Microbial*: swabbing, culturing for pathogens or indicator organisms
Operational Sanitation:
• *Prevent direct product contamination* and adulteration during operations • Develop procedures for cleaning, sanitizing and disinfecting equipment and utensils during production, breaks, *between shifts and at mid-shift cleaning* • Enforce *proper employee hygiene* including personal hygiene, cleanliness of outer garments and gloves, hair restraints, hand washing and health • Develop plans for handling product in *raw and cooked areas*
Successful sanitation programs:
• *Pro-active* approach • *Employee participation* in developing SSOP's • *Ongoing* employee education • Delegation of responsibilities • Management commitment • Monitoring procedures • Record-keeping for verification through inspections and audits
DISPOSITION OF PRODUCT "*UNDER HOLD*"
• *Review data* to identify safety concerns • *Appropriate tests* to verify safety of "held" product • Divert product *to another product* where safety can be assured • *Re-work or re-process* the product (metal detector malfunction) • *Donation*
Maintenance of SSOP's
• *Routinely evaluated* for effectiveness • *Revised* as necessary to reflect changes in facilities, equipment, operations and personnel
Discontinuous Monitoring problems
• *Sensitivity* of test procedure • *Statistical confidence* needed
Continuous Monitoring used when:
• *Variation, spikes or drift* in critical limit may go unnoticed • *Critical limit is very* close to operating limit
Some highlights of prerequisite programs:
• *Water testing* records must be maintained • *The building* should be away from areas of potential contaminants such as feedlots, waste disposal areas. • *Written specifications* of all ingredients should be in place. *Suppliers* should be approved with GMPs and HACCP, etc. Obtain letters of guarantee. • *Proper plant design:* e.g., material receipt and storage area should be separate from process area, doors and windows adequately screened to prevent pests. • *Air* intake should be *filtered.* • *Monitoring* of microbiological contamination in areas of cooking, refrigeration, etc. • *Metal control* may be managed as a CCP (at the end of processing line) • *Proper labeling* of all ingredients and chemicals. • *Complaint Investigations* - Feedback from consumers should be considered carefully. Problems should be corrected. • *Product retrieval* - complete distribution records with lot coding should be maintained.
control points are Numerous for most products
• *supply-chain* • storage temperature • *processing factors* • sanitation practices • deliver system
critical limits of Clostridium botulinum
• 12 log reduction ("12D") - Commercially sterilized • 3 min at 121.1* C
*Salvaging* the product *depends on the process and product*:
• Batch process: *raise temperature* of the cooker • Continuous process: place "*on-hold*" or immediately *re-process* the product (product quality concerns)
General Sanitation Includes the following:
• Cleaning of equipment • Cleaning the facility • Personnel practices • Equipment design and operation • Pest control • Warehousing practices
examples of continuous monitoring
• Cycling of oven temperature • In-line measurement of pH
Record-keeping Requirements:
• Daily SSOP records for implementation, monitoring and *corrective action* • *Initialed and dated* by supervisor • Records kept on-site for at least 48 hours and retained off site for at least 6 months
Pre-Operational Sanitation:
• Develop detailed written procedures for *daily cleaning* of product contact surfaces, equipment and facilities • Describe equipment *disassembly and re-assembly* after cleaning/sanitizing • *Sanitizer approved* for the intended use and prepared according to manufacturer • Use acceptable cleaning techniques
Failure to meet critical limits can mean:
• Evidence of direct *health hazard* • Development of health hazard (canning) • Product not produced under conditions assuring safety and subject to *recall*
All HACCP monitoring records should contain the *following information*:
• Form title • Firm name and location • Time and date • Product identification (including product type, package size, processing line and product code, where applicable) • Actual observation or measurement • Critical limits • Operator's signature or initials • Reviewer's signature or initials • Date of review
controlling microbial hazards: Bacterial Destruction
• Log reduction stands for a 10-fold, one decimal, or 90% reduction in numbers of recoverable bacteria • The 5-log reduction is the value used for some food safety standards and refers to the reduction in the number of microorganisms by 100,000-fold
What will be monitored?
• Measure *carcass temperature* after chilling • Measure *product temperature* after cooking • Measure *product pH* after fermentation, • Conveyor *belt speed*, product thickness, etc.
Development of SSOP's for Meat and Poultry:
• Pre-Operational Sanitation • Operational Sanitation
Implementation and Monitoring - Method, frequency and record-keeping processes associated with monitoring:
• Pre-operational monitoring: Describe, evaluate and *document cleaning effectiveness* for product contact surfaces, equipment and utensils before start-up • Operational monitoring: Describe, evaluate and document *adherence to SSOP's* for direct product contamination and employee practices *during production*, including appropriate *corrective action* + Record retention including corrective actions
continuous monitoring
• Preferred • Data logger or recording chart • e.g., HTST pasteurization at 161F/15 sec or UHT pasteurization at 275F/2 sec
corrective actions include the following:
• Procedure for *re-work* or disposal • Means to *re-establish* sanitary conditions • *Prevent* reoccurrence
record-keeping procedures: general concerns
• Record data in a *timely and accurate fashion* (not pre-recorded or late) • Errors in record are *"lined out"* (not erased), initialed, dated and explained • Use a *standard form* • Reviewed regularly for *completeness* and accuracy
Examples of Parameters that May Be Critical Limits
• Temperature • pH • Moisture level • Line speed • Product visual defects • Time • Flow Rate • Water Activity • Salt concentration • Physical dimensions • Weight • Viscosity • Sanitizer concentration • Operation of a metal detector
in Determining Biological Hazards, evaluate:
• Types of contaminates associated with the food or the process • Characteristics of food • Type of microorganism • What types of controls are in place
Discontinuous Monitoring used when
• continuous monitoring is *impractical* • variability is *low* • operating parameter is *far away* from the critical limit
Discontinuous Monitoring examples
•*Minimum internal cook temperature* of a product (Worse case basis - largest pieces from coldest area of an oven, Random sampling - statistically determined frequency) • Cooking oil temperature: 350°F with a lower critical limit of 300°F
Designating CCP's
•Numbered sequentially (CCP1, CCP2...) •Numbering based on type of hazard (biological, chemical, physical); (CCP B1, CCP B2, CCP C1, CCP C2)
Agency Verification
•Review SSOP's •Review daily records •*Direct observation of implementation*, specific procedures and corrective action •*Direct observation/testing* to assess sanitation
