effective sanitation practices

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Effective Sanitation Practices Presented by John Miller HACCP Consulting Group, LLC For FSIS “How to” Workshops Spring 2009 1

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Page 1: Effective Sanitation Practices

Effective Sanitation Practices

Presented by John Miller

HACCP Consulting Group, LLCFor FSIS “How to” Workshops

Spring 2009

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Page 2: Effective Sanitation Practices

Objectives

By the end of this workshop, you will be able to • Understand agency policy and guidance related to

sanitation, including the regulatory requirements for Sanitation Performance Standards (SPS) and Sanitation Standard Operation Procedures (SSOPs)

• Use practical tools and methods to develop and implement your own sanitation plan that will comply with the regulations and ensure food safety

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Discussion Question

What is your biggest challenge regarding sanitation?

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Why Is It Important to Have a Sanitary Facility?

• To control pathogens and prevent foodborne illness– Listeria monocytogenes– Salmonella– Staphylococcus aureus

• To control normal spoilage bacteria– Yeast– Molds– Others that can cause economic spoilage

and decrease shelf life

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Why Is It Important to Have a Sanitary Facility? (con’t)

• Meet customer expectations• Comply with regulatory requirements

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Sanitary Definitions

Clean—free of visible soil Sanitize—reduce the number of bacteria to a

safe level Sterilize—to make free of bacteria Contamination—the presence of harmful

substances in food

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Factors that Contribute to a Sanitary Facility

Facility design Equipment design Good cleaning and sanitizing procedures Good written sanitation programs and

monitoring procedures

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Evaluating the Effectiveness of a Sanitation Program

Microbiological testing Adenosine triphosphate (ATP) testing Use of sanitation records Training

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Review of Regulatory Requirements

Sanitation Requirements for Official Meat and Poultry Establishments 9 CFR 416• Sanitation Performance Standards (SPS)

9 CFR 416.2–416.6• Sanitation Standard Operating Procedures

9 CFR 416.11–416.17

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Sanitation Requirements for Official Meat and Poultry

Establishments9 CFR 416—Sanitation

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Section 416.1—General Rules

Each official establishment must be operated and maintained in a manner sufficient to prevent insanitary conditions and to ensure that product is not adulterated.

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Sanitation Performance Standards (SPS) 9 CFR 416.2–416.6

Written program not required by FSIS If written, must be monitored and documented

by establishment FSIS will verify establishment’s program Required for custom exempt facilities

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SPS 9 CFR 416.2

Establishment grounds and facilities• grounds and pest control• construction• lighting• ventilation• plumbing• sewage disposal• water supply and water, ice, and solution reuse• dressing rooms/lavatories

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SPS 9 CFR 416.3–416.6

Equipment and utensils Sanitary operations Employee hygiene Tagging insanitary equipment, utensils,

rooms, or compartments

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SPS for Grounds and Pest Control (416.2a)

Grounds must be maintained to prevent conditions that • could lead to insanitary conditions• could lead to adulteration of products• interfere with inspection by FSIS

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SPS for Grounds and Pest Control (416.2a) (con’t)

Program is designed to prevent harborage and breeding of pests.

Pest control substances must be safe and effective.

Substances must be applied and stored to prevent insanitary conditions.

Inspector may request written designation of plant boundaries.

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Grounds and Pest Control: Plant Responsibilities

Verify that pest control is performed by contractor

Tour outside areas to ensure that equipment stored outside is off the ground

Ensure that grass, weeds, and debris are eliminated from premise’s perimeter

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Grounds and Pest Control: FSIS Verification Procedures

Perform normal operational checks Verify that grounds are maintained with no

accumulation of trash, debris, or old equipment See if the pest control program is effective Review EPA registration, labels, and use

instructions Ask the responsible party applying a pesticide

about its proper use

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SPS for Construction (416.2b)

Buildings, structures, rooms, and compartments must be sound, in good repair, and sufficient size.

Walls, floors, and ceilings must be built of durable materials and be cleaned and sanitized as necessary.

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SPS for Construction (416.2b) (con’t)

Walls, floors, ceilings, doors, windows, and other openings must be constructed and maintained to prevent entry of vermin (e.g., flies, rats, and mice).

Rooms in which edible product is processed, handled, or stored must be separate and distinct from inedible product areas to the extent necessary to prevent adulteration of product.

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Construction: Plant Responsibilities

Review facilities to ensure that walls, floors, ceilings, etc., are in good repair

Ensure that doors to outside seal properly to preclude dust, insects, and rodents from entering interior of facility

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SPS for Lighting (416.2c)

Lighting of good quality and sufficient intensity to ensure sanitary conditions is maintained and provided in areas where• equipment and utensils are cleaned• food is processed, handled, stored, or

examined• hand-washing areas, dressing and locker

rooms, and toilets

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Lighting:Plant Responsibilities

Ensure that lighting is adequate and meets regulatory requirements (i.e., 50 ft candles at head, viscera, carcass inspections stations [red meat], 200 ft candles with minimum color rendering index value of 85 at poultry inspection stations).

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SPS for Ventilation (416.2d)

Although ventilation will not be able to completely eliminate all odors, vapors, and condensation, it must control them as far as necessary to prevent adulteration of product or the creation of insanitary conditions.

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Ventilation:Plant Responsibilities

Tour facilities regularly to ensure that air flow and ventilation are adequate to preclude condensation from developing on overhead areas with emphasis on areas where exposed product may be processed or stored

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SPS for Plumbing and Sewage Disposal (416.2e-f)

Plumbing and sewage disposal must be installed and maintained to• carry sufficient quantities of water to

required locations• properly convey sewage from the plant• prevent adulteration of product, water

supplies, and equipment• provide adequate floor drainage

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SPS for Plumbing and Sewage Disposal (416.2e-f) (con’t)

• Prevent back-flow conditions and cross-contamination between piping systems that discharge waste water or sewage and piping systems that carry water for processing

• Prevent the backup of sewer gases

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Plumbing and Sewage Disposal:Plant Responsibilities

Review facilities to ensure that drainage is adequate and does not back up on floors and create contamination issues

Test backflow devices periodically Ensure that water supply is potable through

testing periodically for microorganisms Maintain documentation on file

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SPS for Water Supply and Water, Ice, and Solution Reuse (416.2g)

A supply of running water that complies with the National Primary Drinking Water Regulations (40 CFR Part 141)

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SPS for Dressing Room/Lavatory (416.2h)

Dressing rooms, toilet rooms, and urinals must be • sufficient in number; • of ample size and convenient; • maintained in sanitary condition and good

repair; and• separate from rooms where products are

processed, stored, or handled.

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SPS for Dressing Room/Lavatory (416.2h) (con’t)

Refuse receptacles must be constructed and maintained in a manner that protects against adulteration of product or creation of insanitary conditions.

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SPS for Dressing Room/Lavatory (416.2h) (con’t)

Lavatories must • have running hot and cold water, soap, and

towels• be placed in or near toilet and urinal rooms• placed in the plant to ensure the

cleanliness of all persons handling product

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Dressing Room/Lavatory:Plant Responsibilities

Review welfare areas to ensure that facilities operate properly and area is maintained

Ensure that there is adequate supply of hot water, hand soap, and towels for employees to comply with proper hygiene

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SPS for Equipment and Utensils (416.3)

Equipment and utensils must be of such material and construction to facilitate cleaning and be maintained in a sanitary condition.

Equipment and utensils must not be constructed, located, or operated in ways that prevent their inspection.

Receptacles used to store inedible products must not create insanitary conditions.

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Equipment and Utensils:Plant Responsibilities

Inspect equipment brought into the facility to ensure that it can be cleaned and inspected properly

Ensure that equipment is maintained properly (i.e., no flaking belt material on conveyors, no loose parts that can fall into product, or no loose parts that are constructed of material that may adulterate product)

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SPS for Sanitary Operations (416.4)

All food and non-food contact surfaces must be cleaned and sanitized as frequently as necessary.

Cleaning compounds, sanitizing agents, and processing aids must be safe and effective under the conditions of use.

Product must be protected from adulteration during processing, handling, storage, loading, and unloading.

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SPS for Sanitary Operations (416.4) (con’t)

Non-food contact surfaces of facilities, equipment, and utensils must be cleaned and sanitized as frequently as necessary to prevent insanitary conditions.

During operations, product should not come into contact with non-food contact surfaces.

FSIS no longer approves non-food compounds and proprietary substances.

Documentation substantiating the safety of a chemical’s use must be available for review.

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Sanitary Operations:Plant Responsibilities

Ensure that product handling and sanitation procedures ensure that non-food contact surfaces do not cause adulteration of product

Ensure that all proprietary substances and non-food compounds are safe for their intended use and used appropriately

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SPS for Employee Hygiene (416.5)

Cleanliness• All persons must adhere to hygienic practices

while on duty to prevent adulteration of product. Clothing

• Aprons, frocks, and other outer clothing worn by persons who handle product must be of material that is durable and readily cleaned. Clean garments must be worn at the start of each working day.

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SPS for Employee Hygiene (416.5) (con’t)

Disease control• Any person who has or appears to have an

infectious disease or an open lesion (e.g., boils, sores, or infected wounds) must be excluded from any operations that could result in product adulteration.

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Employee Hygiene:Plant Responsibilities

Train employees in proper hygiene practices Ensure that employees adhere to written

standards for working in processing departments

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SPS for Tagging Insanitary Equipment, Utensils, Rooms, or Compartments (416.6)

FSIS program employee will attach a “U.S. Rejected” tag if any equipment, utensil, room, or compartment is insanitary or its use could cause adulteration of product.

Tagged equipment cannot be used until made acceptable.

Only an FSIS program employee may remove a “U.S. Rejected” tag.

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SANITATION STANDARD OPERATING PROCEDURES

(SSOPs)

9 CFR 416.11–416.17

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Section 416.11—General Rule

Each official establishment shall develop, implement, and maintain written SSOPs in accordance with the requirements of this part.

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Section 416.12—Development of SSOPs

Describe all procedures conducted before and during operations to prevent direct contamination or adulteration of product(s).

SSOP signed and dated by individual with overall authority on site.

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Section 416.12—Development of SSOPs (con’t)

Procedures conducted prior to operations must address cleaning of food contact surfaces, equipment, and utensils.

Specify the frequency of conducting each procedure and the employees responsible for conducting it.

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Section 416.13—Implementation of SSOPs

Establishment must conduct pre-operational procedures in SSOP before start of operations.

Procedures must be conducted at frequencies specified in SSOPs.

Establishment must monitor daily the implementation of the procedures in the SSOPs.

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Section 416.14—Maintenance of SSOPs

Establishment must routinely evaluate the effectiveness of SSOPs and revise if necessary.

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Section 416.15—Corrective Actions

The establishment takes corrective action(s) when either the establishment or FSIS determines the SSOPs have failed.

Corrective actions include • appropriately disposing of product• restoring sanitary conditions• preventing a recurrence• reevaluating/modifying the SOPs

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Section 416.16—Recordkeeping Requirements

Establishment must maintain a daily record to document the implementation and monitoring of the SSOPs and any corrective actions. • The responsible establishment employee

initials and dates the record.

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Section 416.16—Recordkeeping Requirements (con’t)

Records may be maintained on computers provided there are appropriate controls to ensure the integrity of the data.

Records must be maintained for at least 6 months and made accessible to FSIS. All records must be maintained at the establishment for 48 hours and retrievable off site within 24 hours thereafter.

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Section 416.17—Agency Verification

FSIS must verify the adequacy and effectiveness of SSOPs.

Verification may include• reviewing SSOPs• reviewing daily records and corrective actions• directly observing implementation of SSOPs

and any corrective actions taken• directly observing or testing sanitary conditions

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Discussion Question

How do you document deficiencies on your plant’s monitoring record during performance of pre-op sanitation inspection? Why do you use this approach?

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Effective Sanitation

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GMPs SANITARY

EQUIPMENT DESIGN

SANITARY FACILITY DESIGN

HACCP

TRAINEDEMPLOYEES

VALIDATED & VERIFIED PROCESSES

REPEATABLE FOOD SAFETY RESULTS

CONTINUOUS IMPROVEMENT PROCESS

The Food Safety Equation

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… understanding the hazards, then preventing entry points into the facility and the establishment of niches and harborages

Controlling Microbial Hazards

L. monocytogenes E. coli O157:H7 Salmonella Campylobacter Legionella

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Food facilities and equipment must be constructed and be maintainable to ensure that they can be effectively and efficiently cleaned and sanitized over their life. The removal of all food materials is critical. This means preventing bacterial ingress, survival, growth, and reproduction. This includes product and non-product contact surfaces.

Cleanable to a Microbiological Level

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Factors Affecting the Presence and Concentration of Pathogens in Niches

Temperature Moisture Nutrients pH Competitive flora

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Three Broad Sanitation Themes

Provide zones of control Keep it cold and control moisture Design to facilitate sanitation

Which include 11 principles …

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Theme 1: Provide Zones of Control

Create a controllable environment Control the transfer of physical, chemical, or

microbiological hazards into your facility Control the transfer of physical, chemical, or

microbiological hazards from one area of your facility to another

Control post-lethality cross-contamination

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Principle 1

Distinct hygienic zones established in the facility• Requires a hazard analysis of your facility

and the development of a plan to reduce the likelihood of the transfer of those hazards into or within your facility

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Cleanroom

Raw

Processing

RawWelfare

Office

RTE

Welfare

Cook/Ch

illCleanroom

Cleanroom

Cleanroom

SecondaryPackaging

Maintenance

Sanitation

First Aid

Trash

InedibleShipping

Zones of Control

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RawProcessing

RawWelfare Office

RTEWelfare

Cook/Chill

Cleanroom

Cleanroom

Cleanroom

Cleanroom

SecondaryPackaging

Your goal is a logical process flowwith strict zones of control

Zones of Control

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Principle 2

Personnel and material flows controlled to reduce hazards• Requires establishing controls necessary to

manage the flow of people and materials between zones

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Magnetic Lock

Access Control Card Reader

Active ControlPassive Control

From This To This More

Design Sanitary Design

Cross Traffic Aisle

RTE Area

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Theme 2: Keep It Cold and Control Moisture

Control temperature and moisture, which both affect the growth of microorganisms• The drier your facility, the easier it will be to

control microbial growth.• If you are designing a wet process, you

need to manage the water flows to control the risks.

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Principle 3

Water accumulation controlled inside facility• Requires designs that facilitate free

draining of any moisture that is introduced into the facility environment

• Pooling water is a sign of trouble

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From This To This More

Design Sanitary Design

Pooling water

Poor repairs68

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Principle 4

Room temperature and humidity control• Requires a design that maintains the

prescribed temperature, controls condensation, and eliminates fog during the sanitation process

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Principle 5

Room air flow and room air quality control addresses airflow and air quality • Controlled pressurization and air flow

• reduce infiltration of warm, humid air that can cause condensation problems

• reduce dust and dirt problems at outside openings• allow your exhaust systems to work properly and

efficiently

BUILD IT TIGHT AND VENTILATE IT RIGHT

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CleanestRTE Packaging

+ + +

CleanerProduction

+ +

CleanRaw

+

All rooms have their pressure controlled to ensure airflow will be from more clean to less clean areas

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Poor Ventilation Design

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Good Ventilation Design

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Typical Unit Cooler

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Theme 3: Design to Facilitate Sanitation

Create an environment that is easy to maintain in the required sanitary condition• Start thinking about sanitation at the

property line• Specify materials that are easy to clean • Design for the expected life-cycle of the

facility

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Principle 6

Site elements facilitate sanitary conditions• Site design addresses the outside of your

facility. • This is your first line of defense to control

the sanitary conditions at your facility. • Proper site design reduces the risk of

contaminants entering your facility.

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$$$$

$$$

$$

$

$$$$

Your site is your facility’s control perimeter. The cost of control increases as you move toward your intensive hygiene areas.

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Principle 7

Building envelope facilitates sanitary conditions • Addresses the skin of your building—the

building envelope. It keeps in what you need to keep in, keeps out what you don’t want in, and allows proper transfer across the envelope when required.

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Threshold fully embedded in caulk No threshold or seal

Gaps

From This To This More

Design Sanitary Design

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Principle 8

Interior spatial design promotes sanitation• Addresses the proper spatial layout of the

facility• Is there adequate space to access

equipment and building components for sanitation and maintenance?

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From This To This More

Design Sanitary Design

Adequate Equipment Spacing—360° Access

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Principle 9

Building components and construction facilitate sanitary conditions• Addresses the elimination of niches and

harborages through proper specification of materials, finishes, and sanitary design details for the building components

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Sloped girts

Column spaced off of IMP

Galvanized structural steel

Structural Steel Details

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Principle 10

Utility systems designed to prevent contamination• Addresses the elimination of niches and

harborages through proper specification of materials, finishes, and sanitary design details of the utility systems

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From This To This More

Design Sanitary Design

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Principle 11

Sanitation integrated into facility design• Addresses the need to integrate the utilities

and equipment required to support the sanitation process into the facility design

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Hand wash station with floor foamer

Sanitation hose station

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88 Vat washer

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Discussion Question

What challenges did you encounter during the development of your plant’s SSOPs?

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Benefits of Sanitary Equipment Design

Reduced maintenance costs Less labor and chemicals for sanitation Less down time Fewer start-up delays Less microbiological troubleshooting One model—optimized production Minimized risk of recalls

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Items Needed for a Balanced Sanitation Program

Facility Process equipment GMPs Handling practices Sanitation

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Facility

Ceiling condition of acceptable material Wall condition of acceptable material Floor condition of acceptable material Walls and floors in good repair Drains operate correctly Roof condition with no leak and cleanable Adequate heating and cooling capabilities

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Process Equipment

Verifiable preventative maintenance program exists

Equipment designed for clean ability Ladders, catwalks, and crossovers have

protective shields underneath them to protect products and food contact surfaces

No metal-to-metal moving surfaces

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Cleanable and Catwalk over Product

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No Metal to Metal

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Good Manufacturing Practices (GMPs)

Verifiable HACCP plan exists Personal hygiene practices are observed Training program provided for all

maintenance, production, sanitation, and quality personnel

Sanitizer foot baths, floor sprayers, mats, etc., used at entrances to all production areas

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GMPs (con’t)

Frock identification policy is in place and followed for different areas of production

Maintenance personnel have specified uniforms different from production

Product container identification program is in place to clearly identify edible and inedible waste

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Color-Coded Frocks

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Edible, Inedible Markings

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Handling Practices

Products in processing are protected from raw materials

In-process products are not stored with finished products

Temperature-sensitive products are maintained at prescribed temperatures with verification data

Employee handling practice training program is performed on a regular basis with training materials available for review• Do not forget new hires in a high-turnover job

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Sanitation

Management commitment—all levels Equipment—cleanable—no clutter Personnel—trainable—capable of

understanding job Proper clean up time—do not steal time from

sanitation

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Discussion Question

102

How do you document deficiencies in your plant’s monitoring during performance of pre-op sanitation inspection? Why do you use this approach?

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Seven Steps in a SanitationProgram

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Micro-Size

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Step 1—Dry Clean

LOTO (lockout – tag out), secure, and disassemble equipment

Remove gross soils from the equipment and floor

Remove production supplies from the room Remove trash from the room Empty drain baskets

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Secure and Disassemble

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Hollow member + cracked weld

Pre-sanitation task completed consistently (floors swept, equipment covered, materials removed, etc.)

Equipment disassembled to proper level to provide accessibility

Dry clean completed

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Dry Cleanup

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Dry Cleanup

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Step 2—First Rinse

Remove remaining visible soils with hot water (90% to 95% as a benchmark)

Gross soils prohibit effective surface cleaning if not removed prior to detergent application

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Pre-Rinse

Water for pre-rinse should be hot• 120°F to 140°F: Hot enough to melt fat (if

too hot, will bake on the soil)• Use boosted pressure—200 psi with 3/16

nozzle (avoid high pressure because it will create aerosols containing bacteria)

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Pre-Rinse

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Pre-Rinse

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Rinse until visually free of soils Use lowest effective pressure to minimize aerosols and

condensation Lower pressure reduces risk of cross-contamination and

machine damage

Multiple lap joints

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Step 3—Soap and Scour

Foam the walls, then the floor, and then the equipment

Set contact time (i.e., 10 minutes) and do not allow detergent to dry because this may form a stronger soil

Scour to remove films, fats, and proteins Clean drains prior to Step 4

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Order of applications (necessary to reduce cross-contamination potential)• Wall/floors then equipment• Avoid drying of chemicals

Mechanical action

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Bacterial Attachment

Mass with Protective Film (Slime)

Traps Nutrients and Bacteria

Contact time, concentration, and mechanical action!!!• Scrub product contact surfaces daily • Scour framework weekly minimum• Chemicals are not a substitute for mechanical action

Work from walls and floor to equipment

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Cleaning Drains

Use designated brushes Clean with a designated employee at the end

of his/her shift, just prior to sanitizing floor Use a chlorinated alkaline cleaner Clean all surfaces of the drain Sanitize with quat (800 ppm), iodine

(75 ppm), or chlorine (800 ppm) Minimum: clean drains weekly

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Detergent Application

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Detergent Application

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Hand Scrub All Equipment

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Hand Scrub All Equipment

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Step 4—Post Rinse and Inspect

Remove chemical and soils via flood rinse Rinse in the order the detergent was applied:

walls, then the floor, and last the equipment Do not spray the floor once the post rinse of the

equipment begins Use a flashlight to verify cleanliness; should

occur throughout Step 4 100% free of soils, hazes, or water beads; verify

by sight and feel

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Post Rinse and Inspect

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Post Rinse and Inspect

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Step 5—Remove and Assemble

Put on clean outerwear Sanitize hands Verify all chemicals have been removed

(sight, pH paper) Remove all standing water and overhead

condensation Standing water prevents sanitizer contact with

the surface

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Step 5—Remove and Assemble (con’t)

Sanitize inaccessible parts prior to assembling Pre-op inspect parts that will not be

accessible after assembling Assemble (follow LOTO procedures) Relubricate where needed

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Remove and Assemble

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Step 6—Pre-op

Inspect to ensure free of chemicals, tools, and cleaning supplies before starting the equipment, and ensure that guards and safety mechanisms are in place

Run equipment prior to inspecting Complete the formal pre-op spelled out in the plant’s

SSOP Correct all deficiencies and provide feedback to the

person responsible Pre-op the facility regularly for other deficiencies

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Facility Pre-op

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Facility Pre-op

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Step 7—Sanitize

Make sure there is no standing water before beginning production

Flood sanitize equipment—bottom to top (no rinse concentration) and make sure there is no standing sanitizer

Equipment should be run to shed the sanitizer Foam sanitize entire processing area’s wall (5 ft.

minimum) and floor (800 ppm quat minimum) Work your way out of the room Let air dry, squeegee pooling sanitizer

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Periodic Sanitation/Tear Down for Access

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Periodic Sanitation/Heat

Steaming (165°F for 30 minutes) Dry heat (165°F for 4 hours)

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Pop Quiz

135

Do you have access to a copy of 9 CFR 416? Have you read it, and do you understand what it requires from a regulatory standpoint?

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Sanitation Effectiveness Verification

Physical verification• Organoleptic (site, smell,

taste)• Step 6—Pre-op

Microbiological verification• Bioluminescence/ATP (immediate results)• Aerobic plate count (results in 2–3 days)• Environmental monitoring (results in 3–5 days)

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ATP Bioluminescense Testing

Advantages• Quick and immediate results• Measures level of sanitation by looking for

levels of ATP common in food (and bacteria)

• Can track and trend results

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ATP Bioluminescense Testing (con’t)

Disadvantages• Expensive• Does not give you the levels of bacteria on

surfaces, just food residues

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Microbiological Testing

Results in 24–48 hrs Inexpensive Various methods

• Contact plates• Dipsticks• Petrifilm or pour plates• Air testing

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Microbiological Testing (con’t)

Establish internal microbiological standards (10, 50, 100 cfu/square cm)

Develop a testing program and establish a frequency of testing

Track and trend data Critical for ready-to-eat processes (e.g.,

Listeria monocytogenes)

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Sanitation Records

Use all sanitation records to evaluate the effectiveness of your sanitation program:• SSOP records (pre-op, operational, and

corrective action)• ATP/microbiological test results• Track and trend results• Learn from FSIS, NRs

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Training

Critically important Develop specific Standard Operating

Procedures (SOPs) for cleaning and sanitizing equipment

Involve everyone in the plant

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Sanitation and RTE Meat and Poultry Products

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L. monocytogenes

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Why the Concern?

90% of reported cases require hospitalization

20% of cases are fatal CDC estimates 99% of listeriosis is foodborne 0.02% of total foodborne illness, but 28% of

deaths

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Listeria in Meat Plants (n = 41)

Floors 39%

Floor Drains 39%

Cleaning Aides 34%

Wash Areas 24%

Sausage 22%

Food Contact Surfaces 20%

Condensate 7%

Walls & Ceilings 5%

Compressed Air 4%

LOCATION % (+)

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Focused Efforts

Traffic patterns—people and equipment Air flow patterns Employee hygiene and practices Plant design and maintenance Equipment design and maintenance Environmental conditions Cleaning and sanitizing

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Focus on RTE Equipment

Slicers, dicers, and peelers Conveyors Loaders Brine chill systems Horizontal form, fill, and seal machines

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Facility

Ceiling condition of acceptable material Wall condition of acceptable material Floor condition of acceptable material Walls and floors are in good repair Drains operate correctly Roof condition with no leaks and cleanable Adequate heating and cooling capabilities

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Process Equipment

Verifiable preventative maintenance program exists

Equipment designed for clean ability Ladders, catwalks, and crossovers have

protective shields underneath them to protect products and food contact surfaces

No metal-to-metal moving surfaces

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Lead to Ineffective Sanitation

Aerosols Spraying drains and drain components Drains pooling/backing up Hollow rollers, fixed sleeved assemblies, concave

surfaces Cross traffic Lack of accessibility Biofilms Idle equipment (not being used) Standing moisture

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Design Considerations

High-pressure water Compressed air Control buttons and screens Bearings Congestion in RTE area Cabinets in RTE areas Traffic patterns GMP requirements Sanitation process NOT documented/sequenced--How

do you sustain protocols?

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No Niches

No lap joints All welds are continuous, smooth, and

polished Hermetically sealed spacers Sleeved assemblies <1½″ Press fittings are not used Fasteners not used in or above product zone Belt supports constructed from single piece

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Hollow Areas Hermetically Sealed

Drive sprockets and belt pulleys are solid or sealed

Hollow tube construction fully sealed No fastener penetrations into hollow

tubes Threaded leg adjustors—external, no penetration Minimize plates and tags—continuous welds Hollow rollers are not used

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Continuous Improvement

• Traffic Patterns: (separation between raw and RTE, separation between exposed product areas packaging)

• GMPs: (is it difficult to do the wrong thing?)

• Flooring: (infrastructure maintained) • Sanitary Design: (existing equipment + new)

• Effective Sanitation Procedures: (daily and periodic, limitations known and controls in place)

Assess where you for each of the categories.

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Sanitary Design of Food Processing Equipment

Will Reduce Risks and Improve Food Safety

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Resources

http://www.fsis.usda.gov/Science/Resources_&_Information/index.asp

http://www.fsis.usda.gov/Science/Small_Very_Small_Plant_Outreach/index.asp

http://www.fsis.usda.gov/Small_Very_Small_Plants/index.asp

http://www.fsis.usda.gov/Regulations_&_Policies/11000_Series-Facilities_Equipment_&_Sanitation/index.asp

http://www.fsis.usda.gov/News_&_Events/Food_Safety_Inspection_Podcasts/index.asp

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Development ofStandard Operating Procedures

(SOPs)

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Purpose of SOPs

Prevent or minimize problems and possible issues affecting food safety

Ensure the defined procedures are conducted in a consistent manner

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Developing SOPs

Use systematic approach in development Determine the goal of the procedure

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Steps in Developing SOPs

Identify the tasks Use a team approach Conduct analysis of tasks that are determined

to be included in procedure Identify possible operational barriers to

procedure

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Steps in Developing SOPs (con’t)

Task analysis includes• researching regulations, guidelines, and

policies;• reviewing the operation;• identifying the steps in the procedure; and• developing a flow diagram.

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Tools and Techniques for Developing SOPs

Videos, photographs, etc. On-site visual observations Identification of past problems A comparative analysis

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Relevant Questions

Why is the task being done? Who is conducting the task? What are they doing? What is the frequency? What are the limits? What are the corrective (immediate) and

preventive (long-term) measures?

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Elements of a SOP

Steps in the procedure Who is responsible for monitoring Frequency The corrective/preventive measures Records maintained Who approves the SOP Reassessment

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Development ofSanitation Standard Operating

Procedures (SSOPs)

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SSOPs: Identify Reassembly

Per manufacturer’s instructions Prior to slaughter By maintenance personnel or machine

operator

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SSOPs: Recordkeeping Procedures

SSOP on file Daily record of findings Corrective/preventive action records Supporting documentation

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Operational Sanitation Monitoring

Document actions that identify and correct contamination

Document corrective and preventive actions

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Modification of SSOPs

Regulatory changes Equipment/process changes Request for change form Change pages included in SSOP Changes signed and dated

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Operational Sanitation—Cleaning Procedures

Clean and sanitize equipment after contamination

Breaks and mid-shift cleanup Between shifts Product handling Employee hygiene practices

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Pre-Operational Sanitation Monitoring

Identify responsible persons Describe methodology used

• Organoleptic procedures• Chemical monitoring• Microbiological monitoring

• Surface swabs

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Monitoring Frequency

Daily visual inspection prior to startup Daily/weekly swabbing Periodic checks of non-food contact areas

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SSOP Monitoring Methodology

Inspect food contact surfaces Check overhead areas directly over food

contact surfaces Check areas under food contact surfaces that

may impact surfaces*USE A FLASHLIGHT*

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