Food safety guidance document - Innovation Center for US Dairy by langkunxg


									Food Safety Plan                                      Corrective Action/    Laboratory
                   Pest Control   Traceability &      Preventive Action
  (HACCP) (1)                         Recall                               Data Accuracy

                                    Allergen and                             Change
                    Chemical                           External Audit
Premise Control                   Sensitizing Agent                        Management
                     Control        Management            Program

   Receiving/                                          Internal Audit
Storage Controls   Sanitation      Food Security

   Material                       Top Management       Finished Goods
   Control            GMPs         Participation in
                                                         Monitoring            Definitions
                                    Food Safety

  Supplier          Personnel       Regulatory                                 Acronyms
                                                        Monitoring -
 Management          Training       Compliance

                                                                                 Revision 2/27/13
Supply Chain Food Safety Risk Management Programs
       Risk Analysis           Food Safety Plan (HACCP)
 N/A       Min     Best   #    Minimum Practice                                                                        Best Practice
                               The HACCP plan will include all FSMA components and includes: process flow
                               diagrams for each process/product, a hazard analysis on all ingredients and primary     Add equipment and services providers. Environmental pathogen risks and control measures
                               packaging materials, CCP control charts as applicable, and appropriate document         are called out in HACCP plans.
                               controls (revision #'s, etc)
                               A HACCP team is in place that is responsible for developing and modifying the HACCP
                               plan. Team members include a facilitator and a scribe at a minimum. Team is
                                                                                                                   Team rotates members regularly so new employees are trained & former members take their
                          1B   comprised of members from cross functional areas from the plant: Production, QA,
                                                                                                                   knowledge with them back to their regular jobs.
                               Maintenance, etc. One or more team members are from the management team to
                               ensure full support.

                               HACCP Team meets at least annually to review HACCP recordkeeping and/or comply HACCP team meets at least quarterly to review HACCP deviations, CAPA, overall
                               as indicated in the following sections.                                        recordkeeping and compliance to plan.

                               The HACCP plans include CCPs, critical limits, monitoring activities, corrective actions,
                               verification procedures and record keeping procedures. CCPs are validated by
                          1D                                                                                             CCPs are Validated by 3rd party (which could include corporate) annually.
                               documented scientific evidence or validated by historical evidence indicating CCP
                               control measures and limits eliminate or reduce hazards.

                                                                                                                       Prerequisites are reviewed and updated annually at minimum, with documented evidence,
                          1E   Prerequisite programs are in place that support the HACCP program.
                                                                                                                       communication, and inclusion into next HACCP training.

                               The risk assessment is evaluated every 3 years or when a change occurs. The HACCP
                          1F   plan is reviewed annually by plant management and HACCP team to assure process is The risk assessment is evaluated every year or when a change occurs.
                               still accurate.

                               CCPs are verified per the HACCP plan and critical limits are clearly marked and
                                                                                                                       Production unit #'s clearly tie to CCP documentation to indicate when special events are
                          1G   recorded to easily identify deviations. CCP records are reviewed prior to releasing

                                                                                                                       Operational limits are set at more strict limits than CCP limits to provide 'buffer zone' based
                          1H   Operational limits are set at CCP limits.
                                                                                                                       on process history.

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  Requirement           Prerequisite Programs - Premise Control
N/A   Min   Best   #    Minimum Practice                                                                        Best Practice
                                                                                                                Entire facility and grounds are mapped including a floor plan, utilities, surrounding fixtures,
                                                                                                                external/internal traffic flow. Facility utilized Dairy Plant Food Safety Workshop for Medium
                        Facility site and buildings are of suitable construction and design to facilitate       and Large Enterprise "Sanitary Design of Equipment and Facility" to promote best of class
                        maintenance and sanitary operations.                                                    (boc) programs . Facility has utilized the 10 principles as outlined in the "Dairy Facility Design
                                                                                                                Checklist" to access the facilities food safety status.

                   2B   All materials used for construction are approved as appropriate for intended use.       There is a proactive process in place to validate alternative materials/specifications.

                                                                                                               Facility utilized Dairy Plant Food Safety Workshop for Medium and Large Enterprise
                        Floors are constructed of approved materials, suitable for production and sufficiently
                   2C                                                                                          "Controlled Floor Condition" matrix to promote best of class.
                        sloped for liquids to drain.
                        Walls are constructed of approved materials, cleanable, suitable for production area,
                        are light colored and well joined.
                        Ceilings are constructed of approved materials, cleanable, and suitable for
                        production area.
                   2F   Doors have smooth, non-absorbent surfaces, and are close fitting.
                        Openings for material transfers are designed to minimize entry of pests and foreign
                        Windows are constructed of approved materials, durable, shatter resistant,
                        cleanable, and suitable for production area.
                        Stairs and elevators are situated and constructed so that no contamination of
                        product and packaging materials occur.
                        Overhead structures are cleanable, suitable for production area, prevent
                   2J   contamination of product and packaging materials (e.g., through appropriate
                        shielding), and do not hamper cleaning operations.
                        Lighting adopts Food Code requirement for lighting intensity (Foot Candles)
                   2K   throughout the facility and is constructed to prevent contamination in case of
                        Ventilation prevents build-up of heat, steam, condensation, or dust. Ventilation
                        removes contaminated air. Ventilation openings are equipped with close fitting
                        screen or otherwise protected with non-corrosive material. Ventilation design does
                        not create cross contamination risk.
                        Where appropriate, a positive air pressure system (including air flow) shall be in
                   2M                                                                                           The positive air pressure design is mapped, documented, and monitored.

                   2N   Air supply is filtered (target of 1 micron/95% efficiency), screened, and maintained.   Additional filtration for sensitive areas as determined by the risk assessment.
2O    Air systems can be accessed to clean and change filters.

2P    Air intakes are located to prevent the intake of contaminated air.

      Compressed air or gases which have direct or indirect product contact exposure are
                                                                                                Compressed air is monitored for microbial load periodically to ensure adequate
2Q    appropriately dried, filtered, and used in a controlled manner to prevent cross

      Washrooms are segregated from food processing areas, have self-closing doors, and
      are correctly ventilated and maintained.

      Washrooms have hand washing facilities with a number of maintained units
2S    necessary for there convenient use with properly trapped waste pipes connected to Hands free sinks, towels, drying, and door devices are utilized.
      drains. Restrooms drains are not connected to processing drains.

      Hand washing facilities have hot and cold running potable water, soap, sanitizer,
      sanitary hand drying supplies or devices and a cleanable waste receptacle.

      Lunchrooms and change rooms are separate from and do not lead directly into food          Lunchrooms contain separate hand washing equipment in addition to utensil washing
      processing areas.                                                                         equipment.

      Lunchrooms and change rooms are correctly ventilated, maintained, and supplied            Employee lockers have sloped tops to deter storage of items and meshed doors to allow for
      with adequate locker space for employees personal belongings.                             ventilation and ease of inspection.

      Processing areas contain sufficient number of conveniently located hand washing
2W                                                                                              Hand washing sinks are located as you enter production area and are hands free operation.
      stations with properly trapped waste pipes connected to drains.

2X    Drainage and sewage systems are equipped with appropriate traps and vents.
      Areas are designated for the storage and removal of waste and inedible material to        Waste removal traffic patterns are identified and followed to prevent cross contamination
2Y    prevent product contamination. Waste disposal practices are in place and                  with plant traffic. Waste disposal areas are removed from production areas and are sealed to
      documented.                                                                               deter pest entry.
      Microbiological laboratories are designed, located, and operated to prevent               Microbiological laboratories do not open directly onto a production area, are negative
      contamination of people, plant, and products.                                             pressure and externally vented.

      Potable water (inclusive of well sources) is used in all manufacturing processes      If well water is employed additional testing (e.g., pesticides, arsenic, etc.) is performed based
2AA   including steam supply, cooling media, process water, and ice. Potability is          on risk. A treatment program for well water is employed to prevent microbial
      confirmed with microbiological testing using samples taken within the plant location. contamination.

      Incoming water used in processing is filtered. Target is a 5 micron filter. Filters are
2BB                                                                                             Water used in processing is filtered at point of use.
      changed on a scheduled frequency.

      All hoses, taps, cross-connections, or similar sources of possible contamination are
      equipped with anti-backflow devices. Water inlet piping must be a minimum of 1
2CC                                                                                         An established frequency is maintained to test backflow.
      inch above water levels in tanks (e.g., COP) and the air gap between the pipe and the
      flood level needs to be at least 2 times the diameter of the largest inlet pipe.

2DD   Recirculated water has a separate distribution system.                                    Recirculated water is also readily identified.
            2EE   Grounds are free of old equipment, wood, weeds, or debris.
            2FF   An adequate gravel perimeter surrounds the building in non-paved areas.               The perimeter is fully paved.
            2GG   Roadways are properly graded, compacted, and self draining.
                  Facility is located in an area appropriate for food manufacturing and does not pose
                  risk of contamination. (e.g., neighboring plants, facilities, etc.)
                                                                                                        Within the program are guidelines to determine the risks to the product associated with the
                                                                                                        construction and appropriate measures (e.g., physical barriers, traffic patterns, etc.) and
            2II   Facility has a program in place to protect product during times of construction.
                                                                                                        additional monitoring (e.g., environmental pathogens) to be taken before, during, and after

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Supply Chain Food Safety Risk Management Programs
       Risk Analysis           Prerequisite Programs - Receiving/Storage Controls
 N/A       Min     Best   #    Minimum Practice                                                                        Best Practice
                               Documented procedures to receive and inspect inbound materials. Documented
                          3A                                                                                           Immediate capability to provide notice/complaint on defective material.
                               procedures for rejection of materials.

                               All carriers are inspected, acceptability criteria include: no light is visible from inside
                                                                                                                           All inspections to include either video or photography to document load condition, security
                               trailer, no mechanical or other foreign odors are detected, any non-food grade items
                          3B                                                                                               and shipment verification. Trailer temperatures are recorded throughout loading and transit
                               present on trailer do not pose a food safety risk, and adequate temperatures can
                                                                                                                           which may be supplied upon request.
                               be/are maintained. Trailer is swept and/or cleaned as needed prior to loading.

                          3C   A system for documentation of bulk tanker cleaning is in place.                         Verification is in place for this activity.

                                                                                                                       Shipments are pre-approved and shipment documents are verified for accuracy. Appropriate
                               Receiving personnel compare BOL and other shipping documentation against
                          3D                                                                                           receiving personnel or QA reviews and signs off on COA compliance to specification.
                               Purchase Order to assure correct products are received.
                                                                                                                       Document transfer and COA review may occur electronically.
                               Inbound materials are properly packaged, identified, and labeled. A documented
                          3E   food safety protocol exists for the treatment of nonconforming or damaged/exposed Inbound products conform to receivers electronic scanning and bar-coding requirements.

                               Warehouse is completely sealed off from environment and has no holes in walls or
                          3F                                                                                           An 18 inch perimeter is maintained between stored items and walls.
                               ceiling. Materials are stored off the floor.

                                                                                                                       Temperature, positive pressure, humidity, and air exchanges are controlled, monitored, and
                               Temperature-sensitive items are maintained at proper temperatures. Rooms that
                          3G                                                                                           documented. Continuous electronic monitoring of temperature is recorded and available for
                               are temperature controlled are continuously monitored.
                                                                                                                       investigational purposes.
                                                                                                                       New pallets, heat-treated wood pallets, sanitized pallets and/or from approved source are
                                                                                                                       used. Pallets are included in Environmental monitoring program to capture any potential
                          3H   Pallets do not pose a risk for unsanitary, chemical, or physical conditions.
                                                                                                                       contribution. Warehouse has control measures to eliminate dust and the potential for
                                                                                                                       foreign material from pallets.
                               Loading docks (including rail) have loading sleeves and air cushions to protect         Docks and dock plates are contained within the loading dock room (except for rail). Docks
                               product and the warehouse environment while loading/unloading.                          and dock plates are on Master Sanitation schedule.
                               Returned goods are handled in such a manner to protect them from contamination          Returned Goods are pre-dispositioned via a return authorization process. There is a
                               or the contamination of other goods.                                                    quarantine area in the warehouse for returned items.
                               Inventory is kept using a system that allows personnel to quickly identify pallet       Inventory is kept using an electronic system that allows personnel to quickly identify pallet
                               location within the warehouse. Every pallet space is mapped.                            location within the warehouse.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis                Prerequisite Programs - Material Control
 N/A       Min          Best   #    Minimum Practice                                                                        Best Practice
                                    Actual raw material producing location is verified against                              Records are in place to prove chain of custody from producing location to customer receipt
                               4A   the approved supplier list upon receipt. This includes name,                            location. Electronic verification occurs of item and approved supplier manufacturing
                                    address, city, state, country. (In some cases this info is available on the PO.)        location.
                                    Current specifications are on file for all materials and finished products.             A process is in place for a suppliers written acknowledgement / approval of specifications as
                               4B                                                                                           well as acknowledgement of specification changes. Specifications are reviewed and signed
                                                                                                                            on an annual basis.
                                    All materials have a defined inspection program. Where appropriate,
                               4C   materials under inspection are placed on restricted status until inspection is          Only authorized persons can release product.

                                    Where COAs are used to assure food safety requirements are met, a supplier test
                               4D   method verification program exists to assure accuracy of COA data (split samples on     Supplier participates in co-sampling/ proficiency process to validate product results.
                                    periodic basis, supplier participation in proficiency test program).

                                    Finished product is tested by predetermined testing protocol before it is sold.
                                                                                                                            Sampling technique and testing frequencies are validated to be representative of lots or
                               4E   Responsibility for reviewing test results, CCP documents, environmental tests, etc
                                                                                                                            sublots. Positive release program in place.
                                    prior to product release is clearly designated.
                                    Non conforming product is effectively identified and a process is in place to prevent   Nonconforming product is segregated by physical barrier as well as a computer restriction to
                               4F                                                                                           prevent inadvertent use / shipment. Timely disposition is made.
                                    inadvertently use / shipment.
                                    Customer specifications are maintained in such a way so as to prevent product from      Product is checked automatically by computer and non-conforming product is flagged with
   change row spacing          4G
                                    shipping that doesn't meet specifications. Where required, affected customers are       notification to responsible persons.
                                    consulted regarding nonconforming materials prior to shipment. of materials and
                                    An age management program is in place to assure proper rotation                         Automated reporting of at-risk materials based on age to create awareness for usage and/or
                               4H   finished goods.                                                                         disposition.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis           Prerequisite Programs - Supplier Management
 N/A       Min     Best   #    Minimum Practice                                                                       Best Practice
                               A supplier management program exists and provides the following documentation:
                          5A   3rd party audit results with corrective actions, ingredient statement/label, country of The supply chain food safety risk management guidance program has been implemented.
                               origin, address of producing location, allergen information, and HACCP information.

                          5B   Documented procedure is in place to delist an approved supplier.                       System in place to ensure delisted suppliers cannot be utilized.

                                                                                                                      Exception provisions are tied to HACCP Hazard analysis. Follow up process in place to
                          5C   Exception provisions are in place to purchase materials from non-approved suppliers.
                                                                                                                      approve supplier for ongoing requirements or future incidental use.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis           Prerequisite Programs - Personnel Training
 N/A       Min     Best   #    Minimum Practice                                                                         Best Practice
                               GMP Training
                               All employees receive documented training. Training is conducted annually. All
                          6A   visitors/contractors receive GMP training commensurate with the planned activities
                               they will perform. After training is completed, employees are evaluated after a pre-
                               defined time to determine if training was effective.
                               Sanitation Training                                                                      After training is completed, employees are evaluated after a pre-defined time to determine if
                          6B   Employees involved in managing, supervising, and performing sanitation duties            training was effective. Employees receive feedback from pre-op inspections, internal audits
                               receive documented training. Training is conducted annually.                             and customer audits related to sanitation.
                               Allergen Training
                               Facilities which receive ingredients that are considered to be an allergen provide       All employees receive allergen training. After training is completed, employees are evaluated
                               allergen training. This training is documented and covers the modes of failure.          after a pre-defined time to determine if training was effective.
                               Training is conducted annually.
                               Regulatory Training
                          6D   Employees directly responsible for handling the regulatory inspections, recalls, and
                                                                                                                        All employees receive training on how to interact with regulatory personnel.
                               Reportable Food Registry events have documented training.

                               Food Security Training                                                                   Training is tested through use of a vulnerability assessment tool (e.g. FDA FREE-B). After
                          6E   All employees receive food security documented training. Training is conducted           training is completed, employees are evaluated after a pre-defined time to determine if
                               annually.                                                                                training was effective. Training is conducted more frequently, based on risk/threat.

                               HACCP Training
                               Plant Management, Plant HACCP teams, HACCP record reviewers, and CCP monitors
                               receive in-depth HACCP training. This training is documented and validated. After        HACCP Team receive certified HACCP training. Support groups such as R&D and engineering
                               training is completed, employees are evaluated after a pre-defined time to               also receive more in depth HACCP training.
                               determine if training was effective. All plant employees receive basic HACCP training
                               on an annual basis at a minimum.
                               Positive Release Training
                               Employees responsible for positive release / critical records review practices receive   After training is completed, employees are evaluated after a pre-defined time to determine if
                               documented training on the program prior to performing the task and ongoing at a         training was effective.
                               defined frequency.
                               Incident Management Training
                                                                                                                        Table top exercises are used for training. After training is completed, employees are
                               Documented training on the facility's Incident Management Plan to the Incident
                                                                                                                        evaluated after a pre-defined time to determine if training was effective. Process exists
                          6H   Management Team is conducted annually or as needed. This would include
                                                                                                                        where incidents are reviewed to strengthen the awareness and approach to handle such
                               immediate response to potential cross contamination related to allergen, chemical,
                               and pest control.
                               Change Management Training All employees who initiate changes that could impact          Table top exercises are used for training. After training is completed, employees are
                               food safety are trained in CM procedures.                                                evaluated after a pre-defined time to determine if training was effective.

                               General Food Safety Education:
                          6J                                                                                            Education includes zone transfer and source/vector training.
                               A general food safety training session is provided to all employees.
     Specialized Food Safety Management Training:
     - Internal audit                               Internal auditors maintain an audit certification (ASQ Certified Quality Auditor, ASQ Certified
6K   - Sanitarians                                  HACCP Auditor, ISO 9000 Lead Auditor) or have been trained through a recognized food
     - Sanitor                                      industry organization (AIB Internal Auditing, Silliker Internal Auditing).
     - Lab technicians
Supply Chain Food Safety Risk Management Programs
       Risk Analysis           Prerequisite Programs - GMPs
 N/A       Min     Best   #    Minimum Practice                                                                          Best Practice
                               A plant specific GMP program is developed, implemented, and current that clearly
                                                                                                                       A site map defining the hygiene zones/GMP areas is available. Facility utilized Dairy Plant
                               defines GMP expectations for all areas of the manufacturing facility. It identifies and
                          7A                                                                                           Food Safety Workshop for Medium and Large Enterprise "GMP's" matrix to promote best of
                               controls areas of risk that could compromise the integrity of the product, process, or
                                                                                                                       class programs.
                               The plant specific GMP program is reviewed at a defined frequency or when changes
                          7B                                                                                     GMP program is reviewed/updated annually or when changes occur.

                               Personnel Practices are controlled.
                               - Examples include illness and disease notification program, hair control, control of
                          7C   personal items, jewelry control, medication usage, cuts / scrapes, use of metal
                               detectable bandages, provisions for handling / touching product, hand washing
                               requirements, traffic patterns, and job duty restrictions (drain cleaning / raw areas).

                               Uniforms & Work Wear are controlled.
                               - Examples include controlled work clothes/uniform and footwear usage and design; Captive uniform program, including shoes.
                          7D   storage of personal items/street clothes / dirty laundry, laundering requirements,
                               provisions for visitors/contractors/temporary hires, personal protective wear, hair/
                               beard control, point of use work wear cleanliness and storage.

                               Tobacco usage and Food & Drink consumption are controlled.
                                                                                                                 High risk allergen control (e.g., peanuts) program for food in vending machines or brought in
                          7E   - Examples include tobacco usage, food / drink consumption location, uniform/work
                                                                                                                 by employees and or have defined Good Manufacturing Practices to mitigate the risk of cross
                               wear protection, waste disposal, hand washing requirements.
                                                                                                                 contamination when utilizing the lunch/break area.
                               The use of Glass, Brittle or Hard Plastic, and Ceramic materials is controlled or
                               eliminated. A master list of these items is actively maintained, audited annually,
                               and updated. The master list of these items is audited at a frequency based on risk
                          7F   to ensure no breakage has occurred.
                               - Examples include a documented list of all such items, procedures for handling the
                               breaking / cleaning / disposal of such items, requirements for lights / gauges /
                               windows / packaging materials / utensils.

                               Production practices are controlled.
                               - Examples include hand sink / sanitizer locations and use, not placing items on the
                               floor, control on reuse of ingredient / chemical containers, storage & staging of
                               ingredients / packaging, control of wooden items and pallets, traffic patterns.

                               Housekeeping practices are controlled.
                               - Examples include doorway sanitizer (foam/foot bath) maintenance and control,
                               storage of sanitation chemicals, control of condensation, waste handling, provisions
                               for cleaning during production.
     Operational Tools and their use are controlled.
     - Examples include tool condition/design/storage, color code program, drain-cleaning
     equipment segregation, container labeling requirements, nesting restrictions,                 Tools are assigned to owners to account for cleanliness. A program is in place for tool
     sponge/mop/rag/abrasive pad restrictions, control of sharp tools and small metal              reconciliation on a daily basis.
     items, utility knife restrictions, microbiological sensitive tool control, and overall tool
     High Risk Areas are controlled.
     - Examples include access traffic, uniform/footwear/tool control, positive air flow,          Facility utilized Innovation Center for Dairy Research matrix "Separate Raw from RTE" to
     filtered (HEPA) air, water usage, dedicated forklifts and pallets, traffic patterns,          promote best of class programs.
     hygiene junctures.
     Visitors & Contractors are controlled.
     - Examples include GMP expectations for visitors / contractors.

     Foreign Material Prevention/Detection Program.
7L   - Examples include use of screens, sieves, magnets, and metal detectors as late in the Use of more advanced technology, such as x-ray, vision systems, sorting equipment.
     process is practical. Documented calibration program in place.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis           Prerequisite Programs - Sanitation
 N/A       Min     Best   #    Minimum Practice                                                                         Best Practice
                               Sanitation/cleaning procedures and work instructions are documented for all              Sanitarian on staff to support cleaning effectiveness and continuous improvement of staff.
                               production areas, processing equipment, and other parts of the facility. This includes   Facility utilized Dairy Plant Food Safety Workshop for Medium and Large Enterprise. SSOPs
                          8A   the specific area/equipment to be cleaned, critical cleaning requirements (per           follow the sanitation 7-step process. Dairy Plant Pathogen Control Assessment matrix
                               time/temp/concentration validation procedures), cleaning frequency, type/name of         "Sanitation Procedures and Execution" is used to promote best of class programs. Facility has
                               chemical to be used, a list of parts/areas to be manually cleaned when equipment is      utilized the 10 principles as outlined in the "Dairy Products outside the pipe Sanitary design
                               disassembled or cleaned in place, detailed steps of cleaning, person responsible for     Checklist“.
                               cleaning, and the date of issue/revision.
                               A drain-cleaning program is in place that includes drain location maps, cleaning
                               procedures, methods of controlling cross contamination, frequency of cleaning and
                               verification records.
                          8B   - Drains in processing areas are cleaned and sanitized whenever there is a wet wash.
                               They are also sanitized daily.
                               - Floor drain brushes, buckets, and other drain cleaning tools are controlled to
                               prevent cross contamination.                                                             Use of Quat blocks in drains.
                               A Master Sanitation Schedule (MSS) is in place for all production and non-production
                               areas, machinery, equipment, and environment that are not a part of regularly
                               scheduled equipment cleanings. It includes:
                          8C   - Equipment / area / item to be cleaned                                                  The MSS is reviewed and updated annually or when new equipment is added or changes to
                               - Frequency of cleaning                                                                  the building are made. A goal has been established for completion of MSS items and is
                               - Person responsible for cleaning                                                        tracked on a monthly basis with verification activities being completed by a trained
                               - Cleaning verification records                                                          employee.

                                                                                                                  Sanitary design is based on established industry standards. Facility has utilized Dairy Plant
                               Processing equipment is designed and constructed to be cleanable and is maintained Food Safety Workshop for Medium and Large Enterprise matrix "Sanitary Design of
                               in a sanitary condition.                                                           Equipment and Facility" to promote best of class programs.
                               Tools for sanitation are stored in a clean, dry and sanitary manner; are controlled
                          8E   through labeling or color coding; and are not interchanged or stored with production Tools are assigned to owners to account for cleanliness. A program is in place for tool
                               or janitorial tools.                                                                 reconciliation on a daily basis.

                          8F   Sponges, reusable cloth towels, and wooden handled tools are not used for
                               sanitation. Mop heads are single use only if used in production (Z1,2,3) areas. Wire
                               brushes and fibrous scouring pads are avoided or controlled properly.
                               Plant water used for sanitation is analyzed annually for complete mineral/chemical
                          8G   composition to ensure effectiveness and efficiency of the sanitation chemicals being
                               used.                                                                                    More frequent testing of water based on water shed changes throughout the year.

                          8H   Reused water, when used for sanitation purposes, complies with regulatory
                               requirements. Reused (COW) water shall not be used as a final rinse.
8I   Raw equipment and pasteurized equipment are not washed or sanitized by the same
     CIP/ACS/COP equipment.                                                          Equipment ID color - coded to differentiate raw and pasteurized areas and kept separate.

8J   Areas that require dry cleaning are kept dry. When moisture is introduced into a dry
     area, plans are in place to quickly and thoroughly remove moisture from the area.

8K   Sanitation data is monitored and trended to determine the effectiveness of              Data is shared with chemical vendors to support chemical changes or improved cleaning
     sanitation over time. Corrective actions are issued and tracked.                        systems.
     A pre-operational (Pre-Op) program is in place that documents visual inspection,
8L   review of sanitation records and line equipment for production after each sanitation
     cycle/circuit.                                                                       Actionable limits are established in the Pre-Op to govern decisions for discrepancies.
     Central sanitizer dispensing system concentrations are monitored daily, with all drop
8M   stations monitored at least once per month. Dispensing systems should run 30
     seconds prior to sample capture.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis           Prerequisite Programs - Chemical Control
 N/A       Min     Best   #    Minimum Practice                                                                         Best Practice
                          9A   A chemical control program manages the use, storage, controlled access, and              Any chemical on the floor that is not in use solution, needs to be secured, regardless of
                               handling of non-food chemicals at the manufacturing facility.                            container size.

                                                                                                                        Chemical control program includes list of chemicals , description of chemicals, verification
                          9B                                                                                            that the chemical is appropriate for its intended use, and suggested/legal use concentrations.
                               Approved vendor and chemicals lists are maintained. Procedure is in place at             MSDS sheets are maintained up-to-date. Letters of Guaranty are on file for all chemicals. No
                               receiving to compare incoming chemicals to approved vendor list.                         new chemicals are received into facility without management review and approval.
                               A chemical list categorizing types of chemicals is maintained: cleaning chemicals,
                          9C   maintenance chemicals, boiler treatment chemicals, Pest Control chemicals, Potable
                               water treatment chemicals, waste water treatment chemicals, Laboratory chemicals,
                               office chemicals, processing aids.
                               Non-food grade hazardous chemicals are stored away from all product. A log is
                          9D   maintained detailing who used a chemical, how much was used, when it was taken
                               and when it was returned.                                                                Hazardous chemicals are phased out of normal use where possible.

                          9E   All containers are clearly labeled with proper chemical label regarding their contents
                               and size.

                          9F   Chemical usage rates are clearly outlined by SOPs and follow manufacturer                Usage is tracked and trended to identify periods of increased or decreased usage and
                               recommendation. Usage monitoring procedures are clear and accurate.                      subsequent reasoning.

                          9G   All lubricants used on food processing equipment, or that may contact food, are
                               approved for use in food applications.
                               Empty chemical containers are discarded, or re-used in such a way to prevent cross
                          9H   contamination. Smaller containers used in plant shall be rinsed out before re-use to
                               prevent cross-contamination.                                                             Supplier participates in a container recovery / recycling program.
                          9I   Facility has on file proper disposal procedures for each chemical used.                  Facility has disposal records to support the procedure.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Prerequisite Programs - Pest Control
 N/A       Min     Best   #     Minimum Practice                                                                        Best Practice
                                A pest control program is in place, documented, maintained, reviewed, assessed, and
                                kept current. The program contains (but is not limited to):
                                - Supplier/Pest Control Company Name and Operator Information
                                - Schematic of the facility outlining pest device placement
                                - Contract listing services provided
                                - Pest Control Company Certificate of Insurance
                                - Copy of Pest Control Applicator License
                                - Photocopy of the Pest Control Operator’s Applicator’s License
                                - Documented Inspection Summaries (including activity log and corrective actions)
                                - Pesticide/bait usage log (including lot number)
                                - Copies of all chemical labels and MSDS’s
                                - Self assessment

                                Pesticide Application and control responsibility, even if performed by a contracted
                                service, rests with the facilities management. Minimum documentation to be
                                maintained on site include:
                          10B   - Application method
                                - Manufacturers instructions for use
                                - Safety equipment used for the application of pesticides within the facility/grounds
                                - Post treatment procedures

                                The Pest Control Operator (PCO) provides a written summary of each visit and these
                                will be kept and reviewed by the facility. Documented preventative and corrective  Facility tracks and trends data on an at least quarterly basis and puts together corrective
                                actions are taken. Internal traps are checked weekly. External traps are checked   actions for any trends noted. Internal inspections supplement PCO frequency.
                                monthly. All inspection results are verified.

                          10D   Non-EPA or equivalent registered pesticides are not used at the facility.

                                Pesticides are not stored at the manufacturing location. Pesticides are stored in
                                separate and locked storage areas.
                                Insect Light Traps (ILTs), if used, are located to prevent contamination of finished
                          10F   product, ingredients, and packaging, and are not visible from the outside.
                                Insectocuters are not used in any location where food, packaging, or food contact
                                equipment are located.
                                Bait Stations are used only on the exterior of the plant and are checked and cleaned
                          10G                                                                                           Simulated findings are placed in traps to verify PCO inspection.
                                as needed. Discretion may be used during winter months.
                                Only baitless traps are used indoors. These traps are placed around the perimeter of
                                the facility and are checked at an appropriate frequency.
      Pesticide usage records are kept for the period necessary to meet state or local
      regulatory requirements.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Prerequisite Programs - Traceability & Recall
 N/A       Min     Best   #     Minimum Practice                                                                     Best Practice
                                All materials (including multicomponents) used in the manufacture of products
                                                                                                                     Electronic tracking program in place. Traceability can be performed from source to
                          11A   (ingredients, processing aids, food contact packaging, rework, finished goods) are
                                                                                                                     destination of final product.
                                identified with lot and date code, and are traceable one forward and one backward.

                                The coding format is agreed upon with contract manufacturers and understood with
                          11B                                                                                    Coding format includes time stamping.
                                licensees, joint ventures and raw material suppliers.

                                A product specific production lot code is not to exceed a clean up to clean up
                                production period.
                          11D   Specified coding is applied and legible on every unit.
                                Traceability records are maintained throughout the manufacturing and distribution
                          11E   process, including product disposals and returns for a period consistent with        Traceability records are kept on file consistent with the companies record retention policy.
                                regulatory requirements.

                                Traceability effectiveness is tested, verified and documented with necessary         Traceability exercises take place quarterly, with monthly follow-ups when parameters are not
                          11F   corrective actions implemented twice per year for finished goods items, ingredients, met. Exercises are done on all shifts to ensure redundancy of capabilities. Conduct both
                                and food contact packaging.                                                          traceability and broader cross functional communication and execution.

                                The target of traceability is 100% within 4 hours of starting the trace for all
                          11G                                                                                        100% recovery in 2 hours.
                                Periodic “Clean Breaks” are made to limit exposure such as rework cycles and bulk
                          11H                                                                                        Clean breaks are managed in shorter intervals, appropriate to product type and risk.
                                Where contractual requirements exist notification will occur prior to recall or
                          11I                                                                                        All impacted customers/suppliers are notified prior to recall or regulatory reporting.
                                regulatory reporting.

                          11J   A recall program is in place and documented.

                                Listing of corporate and plant contacts is on file and updated annually. Contact     Contact numbers are proactively validated for accuracy. Suppliers are required to provide
                                information for relevant regulatory agencies is on file.                             updates as team members change.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Prerequisite Programs - Allergen and Sensitizing Agent Management
 N/A       Min     Best   #     Minimum Practice                                                                          Best Practice
                                The Big 8 Allergens are controlled and managed:
                                - Peanuts
                                - Tree nuts
                                - Eggs
                                                                                                                       The facility is aware of allergens other than the big 8 that are important in countries that the
                                - Milk
                          12A                                                                                          facility may be shipping product to, such as sesame, celery, as well as other sensitizing agents
                                - Wheat
                                                                                                                       (MSG & Yellow #5).
                                - Fish
                                - Crustacean
                                - Soy (including soy lecithin) – Soybean oil if Refined, Bleached and Deodorized (RBD)
                                will not be considered an allergen
                                A program exists that addresses allergen modes of failure:
                                - Ingredient Management
                                - Scheduling / Sequencing (Including Changeovers)
                                - Cleaning / Sanitation
                                - Rework
                                - Incorrect packaging / Labeling
                                - Cross Contamination
                                - Other

                                Facilities that receive an ingredient considered to be an allergen or sensitizing agent
                                have a current documented risk assessment on file which includes control steps used
                                to mitigate the risk.
                                This assessment includes:
                                - A documented review to determine if any allergens are present in the plant. (i.e.
                                ingredients, chemicals such as lubricants, lunchrooms, vending machines)
                                - A list of formulas and labels for the allergens contained in them
                                - An allergen matrix of products and/or operations which handle or process the
                                allergen(s). This matrix is used to clearly identify the allergens that require control
                                - The methods or procedures used to control the allergens within the facility

                                Products which contain or may contain an allergen or sensitizing agent are included
                          12D   on the ingredient statement regardless if it is intentional or incidental addition and    Full segregation and identification of unique allergen containing processes is maintained.
                                follow industry guidance.

                                Product that is intended for export conforms to the allergen regulations of the
                                country or countries where they are to be sold.
      Allergen containing ingredients, packaging material, or finished products as well as
      sensitizing agents are stored in a manner to prevent cross contamination. (e.g.,
12F   Different types of allergens need to be separated.)
      Cross contamination between ingredients and finished products containing different
      allergens is also controlled.
      If sanitation is determined to be a mechanism for allergen control, procedures are
      validated to demonstrate the effectiveness in removing the allergenic substance.

      Visual verification of the effectiveness of each allergen clean is documented after
12H                                                                                          Verification is via means of a validated test kit, on a frequency per the risk assessment.
      each instance where sanitation is used as an allergen control step.

      Rework containing an allergen or sensitizing agent is clearly identified and is only
      used in products which contain the same allergen or sensitizing agent.

      Sensitizing agents are not true allergens and thus are managed separately from
      allergens. The following are Sensitizing Agents to be controlled and managed :
      - Sulfites
12J   - FD&C Colors
      - Monosodium Glutamate (MSG)
      - Autolyzed Yeast Extract
      - Hydrolyzed Proteins

      At a minimum, sensitizing agents follow the practices listed below:
12K   - Labeled per application regulations
      - Managed and controlled, including in the rework control program.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Prerequisite Programs - Food Security
 N/A       Min     Best   #     Minimum Practice                                                                            Best Practice
                                Responsibility for the security of the operations been defined within the plant             Written program in place that includes an annual re-assessment of the plant security along
                                management.                                                                                 with follow up activities and responsibilities assigned.

                                                                                                                            Door control & entry into the building is controlled by key fobs or key cards. Key fobs or scan
                                                                                                                            cards only work during employees' scheduled shift to prevent entry during off hours or when
                                                                                                                            an employee is not scheduled to work (without controlled approval). Employees have access
                          13B   All doors are self closing & locking, and can't be opened from the outside.                 limited to their areas within the facility (e.g. fobs only allow entry access to pre-approved
                                                                                                                            areas). Alarms sound if doors are tampered with, or if doors are not fully closed for a
                                                                                                                            predefined period of time. Computer system tracks each use of key fab or scan card so
                                                                                                                            company knows who was in the facility in case of an incident.

                                                                                                                        Visitors are issued badges or name tags, and are accompanied by an escort when entering
                                Visitors must sign in/out and receive a tag designating them as visitors. Plant has and production floor. All visitors are scheduled in advance. Identification verified (e.g. Driver's
                                follows a documented program for visitors and contractors.                              License), recorded, and reconciled daily with perimeter entry logs. Photograph permissions
                                                                                                                        are controlled.

                                                                                                                            Periodic checks occur for security during off shifts and off hour time periods with verification
                          13D   Employees are trained to help monitor security on a daily basis.
                                                                                                                            that all lights and cameras are functioning.

                                Incoming deliveries must be locked (consistent with company policy), or sealed with
                                                                                                                       All inbound deliveries are on a schedule and must pass through a check station before
                                a numbered seal, receiving personnel to verify against the BOL that the seal # has not
                          13E                                                                                          entering receiving area. Employee of company breaks seal or applies the seal on outbound
                                changed. All outbound deliveries are done so under locked and sealed transportation
                                with seal numbers assigned.
                                All potential entry points are secure: roof opening, vents, plant utilities (water & air)
                                Exterior of facility is well lighted and contains appropriate signage to deter              Facility perimeter is surrounded by a secured fence, with security gate manned by security
                                trespassers.                                                                                guards. Cameras also in place at perimeter entry points.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Top Management Participation in Food Safety
 N/A       Min     Best   #     Minimum Practice                                                                        Best Practice
                                                                                                                        A formal food safety policy exists and is signed by executive management. An organizational
                          14A   Senior management actively supports the food safety practices and programs.
                                                                                                                        chart depicts the food safety leadership chain of command.
                                                                                                                        Employees, suppliers, and customers are aware of company's food safety policy e.g. plant
                          14B   Employees are aware of company's food safety commitment.
                                                                                                                        postings of their Food safety Policy.

                                Adequate resources are provided to implement, maintain, document, and make              Leading internal and or external Food Safety resources are provided to implement, maintain,
                                improvements to the food safety program.                                                document, and make improvements to the food safety program.

                                Senior Management review meetings are conducted annually or as appropriate to
                          14D                                                                                           Food Safety metrics are in place to monitor at review meetings.
                                review food safety findings and corrective actions.

                          14E   Management regularly participates in food safety training.                              Senior Management regularly participates in food safety training.

                                Management responsibility & accountability are assigned and documented for              Verification that food safety plan elements are implemented and maintained as described in
                                required Food Safety Plan elements.                                                     the food safety plan.

                                Observation or evidence that management is dedicated to food safety and have            All job descriptions describe food safety responsibilities. Training and continuing education is
                                sufficient knowledge, resources and technical skills to run a program.                  required in order to support the requirements of the food safety plan.

                          14H   Food safety records are maintained for the above activities for a minimum of 2 years.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Regulatory Compliance
 N/A       Min     Best   #     Minimum Practice                                                                    Best Practice
                                                                                                                    Use of a 3rd-party for registration verification and more frequent updating of information.
                                All producing locations are registered (with bi-annual renewal) with USDHHS / FDA
                          15A                                                                                       (e.g., Registration & Licensing Systems, Inc. has quarterly renewal/update of information -
                                (as required by the FSMA).
                                Company maintains all necessary licenses, registrations, permits, approvals, and
                          15B   authorizations required by regulatory agencies. Copies are readily available for
                                Regulatory audit results for past 5 years that may contain any FDA official action
                                indicated (OAIs) and voluntary action indicated (VAIs); USDA Noncompliance Records Company has written procedures for working with regulatory personnel during visits.
                                (NR) and/or Notice of Intended Enforcement (NOIE) must provide written corrective Responsible employees have documented training.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Microbial Monitoring - Environmental
 N/A       Min     Best   #     Minimum Practice                                                                         Best Practice
                                Pathogen Environmental Monitoring (PEM) program actively detects pathogens in            PEM program aggressively focuses on Zones 2, 3 & 4, enables early detection & elimination,
                                the plant environment and is reviewed annually.                                          and sites are reviewed annually. It is based on historical data, experience and science.

                                Corrective actions are taken to eliminate the cause of an environmental positive.        Corrective actions are not only effective, appropriate and documented, but also proactive,
                                They are effective, appropriate and documented.                                          preventative and shared among plants where beneficial.

                                The PEM is designed to detect pathogens that are associated with the products being
                                manufactured. Liquid dairy production plants focus on Listeria and dry dairy
                                                                                                                    ME+ Program leadership actively seeks the newest information about pathogen risk and
                          16C   production plants focus on Salmonella and other pertinent pathogens (i.e.,
                                                                                                                    detection so the PEM is consistent with the industry.
                                Cronobacter sakazakii , etc.). Additionally the PEM incorporates some of both
                                organism to ensure robustness.

                                                                                                                   Data are accessible, analyzed and trended so that systemic or repeated issues are quickly
                                Data are stored in a format that allows access to employees working on the PEM and
                                                                                                                   identified and acted upon. Trends in seasonality, special events, vacations, etc. are identified
                          16D   appropriate plant leadership. Data are analyzed for trends and the trends acted
                                                                                                                   and acted upon. Potential industry trends are shared with industry partners. Records are
                                upon by plant leadership.
                                                                                                                   also readily accessible to corporate program leadership.

                                                                                                                    Employees performing PEM functions are properly trained in technique and site selection
                                PEM functions are performed by employees that are trained in proper technique and
                                                                                                                    and swab with authority. Training also includes troubleshooting and investigational swabbing
                          16E   site selection. Training also includes troubleshooting and investigational swabbing
                                                                                                                    (vectoring). Additionally, they are encouraged to research PEM improvements and upgrades
                                (vectoring). This training is documented.
                                                                                                                    for implementation.

                                                                                                                         PEM program is dynamic and robust, incorporating static, rotating and random sites along
                                Program states quantities, locations, schedule and responsibilities. This can include
                          16F                                                                                            with quantities that account for risk, such as raw/RTE crossover, facility/equipment
                                static, rotating, and random site selection based off a strategy.
                                                                                                                         age/condition, history, product type, etc. per risk assessment.
                                Swab materials and test methods are selected based on scientific knowledge and
                                generally accepted by the industry. Methods are documented, have AOAC approval,          In addition to minimum expectations, materials and methods are selected based off an
                                are ELISA or PCR based and validated. Materials are lot traceable and consistent with    analysis of the choices and reviewed with a third party (industry group, accredited
                                chemicals used in the facility (i.e. neutralizing buffer selection). Suspect or          laboratory, etc.). New materials and methods are analyzed for risks/benefits and run
                                presumptive positives are treated as positive unless cultural confirmation proves        through a validation study before being put into use.
                                                                                                                         PEM program implementation has taken all variation into account including maintenance
                                PEM program implementation has taken variation into account, with samples taken
                                                                                                                         and construction activities, special operational conditions with cross-functional interface
                                at different times, different days, on different shift while taking system cleanliness
                          16H                                                                                            between all plant groups. Majority of samples taken during production or the time when
                                into consideration; some samples taken during production. The program allows for
                                                                                                                         highest positives are likely to occur. The program allows for random investigational swabs in
                                random investigational swabs in addition to the routine.
                                                                                                                         addition to the routine.
                                                                                                                         In addition to the process for special events, a process exists for swabbing all new incoming
                                A process is established for special events that require swabbing, regardless of time
                          16I                                                                                            equipment and pre- and post-swabbing for construction events along with a detailed written
                                or day.
                                                                                                                         plan for ensure food safety during planned special events.
                                                                                             In addition to the temporary traffic, GMP and sanitation mitigation, employees are trained to
      Where areas are positive or potentially positive, traffic is re-routed, extra GMPs are spot the signs of potentially positive areas and take action while alerting plant management.
      employed and/or sanitation is increased to provide temporary mitigation of an issue. Learning's from positives are cross-checked against similar areas and good practices
                                                                                             implemented where appropriate.
                                                                                           Retesting proves consecutive negatives (minimum 3) and vectoring is immediate and
      Positives are followed up with retesting to prove consecutive negatives (minimum 3).
16K                                                                                        aggressive. Swabbing of potential sources include the easily reachable surfaces as well as
      Source identification (vectoring) occurs and is thorough.
                                                                                           those that are hidden.
      Environmental findings are generally aligned with improvements to infrastructure
      and equipment to minimize harborage and uncleanable areas, but a formal process Risk assessment is a key driver for improvements to infrastructure and equipment based on
16L   for risk assessment may not be employed. Additional resources (such as employees, prioritization of equipment and infrastructure condition and contamination related to
      cleaning & sanitizing chemicals, maintenance activities, etc.) are dedicated to   environmental findings. There is strategic designation of resources to align with the findings.
      environmental findings where appropriate.

      Compositing is limited to 5 or less “like” samples and does not occur in areas with a
      recent history of positives. A separate sponge is used for each site. Compositing
      methods are validated to ensure detectability. Compositing of greater than 5
      samples may be done through a validated method.

      Zone 1 pathogen samples are not taken unless there are specific circumstances that
16N   support the need. Affected product, between validated clean-ups, is put on hold
      until results are available.
      The PEM takes into account plant conditions. Cold or wet areas are sampled for
      Listeria. Dry or dusty areas are sampled for Salmonella. Other pathogens are        Program leadership actively seeks the newest information about pathogen risk conditions
      sampled as appropriate based on plant conditions. Air monitoring is conducted as an and detection so the PEM is consistent with dairy industry practices.
      early indicator of potential micro issues.
      PEM sites and quantities are selected based on zones, drain locations/quantities,
                                                                                              Zones, maps, layouts drive PEM quantities and locations. Quantities are based off facility size,
      equipment/plant layouts as it relates to pathogen risk. Quantities are based off
16P                                                                                           equipment amount, layout and workflow. A site map is used to define raw, RTE, HH, and
      facility size, equipment amount, layout and workflow. A site map is used to define
                                                                                              zone 4 areas.
      raw, RTE, HH, and zone 4 areas.

      As a guideline PEM samples are collected at least weekly and include samples at eye As a guideline PEM samples are collected at least weekly and include samples at eye level,
16Q   level, below and above. A minimum of 30 swabs are taken per 50,000 sq. ft. per      below and above. Greater than 55 swabs are taken per 50,000 sq. ft. per week: Raw:14,
      week: Raw:7, RTE/HH: 20, Zone 4: 3                                                  RTE/HH 35, Zone 4: 6. As facility ages, swabbing increases to reflect increased risks.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Finished Goods Monitoring
 N/A       Min     Best   #     Minimum Practice                                                                       Best Practice
                                A finished product indicator organism testing program exists to assure ongoing safety
                          17A                                                                                         Finished product microbiological testing program includes predefined pathogen testing.
                                of products.

                                Finished products pathogen testing is conducted periodically to verify HACCP Plan
                          17B                                                                                          Challenge studies are on file validating product design and microbiological stability.

                                Finished products that are tested for pathogens remain on HOLD until results are
                                received and are negative. This includes all applicable product from clean to clean.

                          17D   Finished product retention samples are collected and maintained.                       Raw material retention samples are collected and maintained.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Internal Audit Program
 N/A       Min     Best   #     Minimum Practice                                                                      Best Practice
                                Internal audits are conducted at a frequency to assure food safety:                 -
                                GMP - weekly;                                                                    -
                                Positive Air Pressure -entire facility annually;                                      -
                                Hand Washing Water Temperature-entire facility annually;                         - Glass
                                                                                                                         Internal audits additionally include Finished Product Label accuracy. Audit findings are
                          18A   and Hard Plastic-entire facility annually;                             - HACCP
                                                                                                                         tracked and trended and shared with employees to continually improve food safety practices.
                                Prerequisite Programs-annually;                                          - HACCP Plan-
                                annually;                                                          - Laboratory
                                Methods associated with food safety (pH, salt, Aw, moisture, coliform, E. coli)-
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            External Audit Program
 N/A       Min     Best   #     Minimum Practice                                                                   Best Practice
                                A minimum of one 3rd party audit is conducted on the food safety system annually
                          19A                                                                                      A GFSI certification type audit conducted annually.
                                for all food and food contact material. (other suppliers based on risk)

                                A company performed food safety audit is conducted on suppliers based on risk.
                          19B                                                                                      A food safety audit is performed annually.
                                (You audit your supplier.)

                          19C   Audits are conducted during normal working hours with prior notice.                Audits may be conducted at any time the facility is in operation.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Corrective Action / Preventive Action Program
 N/A       Min     Best   #     Minimum Practice                                                                     Best Practice
                                                                                                                     A documented review process is in place to transfer learning's to other risk areas, preventing
                                                                                                                     similar problems from occurring elsewhere in the facility. Specific responsibilities are
                                A documented corrective action program exists for any deviation/finding related to
                          20A                                                                                        assigned. Pre defined timelines for corrections are established and documented, with
                                food safety.
                                                                                                                     performance tracking measured against targets. Evidence of proactive continuous
                                                                                                                     improvement efforts in advance of audit activity.

                          20B   Effective correction is verified before closing the corrective action.               A defined Root Cause Analysis process is followed to determine cause of deviation/finding.

                                                                                                                     Metrics are in place with pre defined improvement targets to drive performance in
                          20C   Recurring deviations/findings are given high priority.
                                                                                                                     elimination/reduction of food safety nonconformance's.
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Laboratory Data Accuracy
 N/A       Min     Best   #     Minimum Practice                                                                       Best Practice
                                Laboratory methods follow accredited methods (Standard Methods for the
                          21A   Examination of Dairy Products, AOAC, BAM, etc.). Changes to accredited methods         SPC tools utilized to ensure testing methods are in control.
                                have been validated using statistically valid sample sizes.
                                Equipment and monitoring devices are calibrated in accordance with the
                                method/frequency per manufacturers instructions.

                                Water monitoring is conducted to assure that it meets Microbiologically Suitable
                                (MS) standards or Laboratory Grade (LG) standards depending on its use.

                          21D   Records are maintained on incoming media, reagents, and sterile supplies.
                                Preventive maintenance is performed on laboratory equipment on scheduled
                                Perform required laboratory quality controls (e.g., agar weight loss, dilution water
                          21G   Lab participates in a proficiency testing program.                                     Every analyst participates in proficiency testing program.
                          21H   When external laboratories are used, they are accredited (e.g., ISO 17025).
Supply Chain Food Safety Risk Management Programs
       Risk Analysis            Change Management Process
 N/A       Min     Best   #     Minimum Practice                                                                       Best Practice
                                                                                                                       Formal communication and approval procedures are documented for disseminating the
                                A process to manage changes that impact food safety is in place. This applies to all   change to all applicable levels/departments within the facility/company. Management of
                                program areas and anything else that impacts food safety.                              Change (MOC) document is routed for formal sign off at the appropriate level within each
                                                                                                                       affected department.
                                Changes are reviewed by HACCP Team to determine if Risk Assessments, Flow
                                Diagrams, and/or HACCP plans require updating. HACCP updates are made prior to
                                change being implemented. HACCP Team sign off is required before change is

                                There is a process in place to monitor industry food safety occurrences, emerging
                                                                                                                       Industry related food safety incidents are communicated to appropriate levels in the
                          22C   pathogens, new food safety hazards, and revised regulatory guidance. Risk
                                                                                                                       organization for awareness of food safety importance.
                                Assessments and HACCP Plans are updated to reflect new risks.

                          22D   All impacted customers are notified consistent with contractual requirements.          Customers are proactively engaged throughout the change process.
Management - individuals managing the day to day operations within a facility

Senior Management - individuals responsible for overseeing the whole organization
                     and typically engaged in more strategic and conceptual matters,
                     with less attention to day to day detail

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ASQ      American Society for Quality
Aw       Water Activity
BOL      Bill of Lading
CAPA     Corrective Action Preventive Action
CCP      Critical Control Point
CIP      Clean In Place
CM       Change Management
COA      Certificate of Analysis
COP      Clean Out of Place
EPA      Environmental Protection Agency
FDA      Food & Drug Administration
FREE-B   Food Related Emergency Exercise Boxed set
FSMA     Food Safety Modernization Act
GFSI     Global Food Safety Initiative
GMP      Good Manufacturing Practices
HACCP    Hazard Analysis Critical Control Point
ILT      Insect Light Traps
ISO      International Organization of Standardization
MOC      Management of Change
MSDS     Material Safety Data Sheet
PCO      Pest Control Operator
PEM      Pathogen Environmental Monitoring
PO       Purchase Order
QA       Quality Assurance
RTE      Ready To Eat
SOP      Standard Operating Procedure
SSOP     Sanitation Standard Operating Procedure
USDA     United States Department of Agriculture
USDHHS   United States Department of Health & Human Services

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