Food NW - Listeria Control Checklist

Listeria Control
Checklist
for Frozen Vegetable
Operations
Version 2.0, January 2018

Frozen Vegetable Workgroup ................................................................................................... 4
Definitions............................................................................................................................... 4
Introduction ............................................................................................................................ 5
Part 1: Basic Listeria Control Strategies for Food Processing ................................................. 6
Sanitary Design of Facilities and Amenities .......................................................... 6
General ........................................................................................................................... 6
Grounds................................................................................................................ 6
Facility .......................................................................................................... 7
Walls, Floors and Drainage, Ceilings...................................................... 7
Traffic Patterns .................................................................................. 7
Fixtures, Ducts, Plumbing, Lighting.............................................. 7
Air Flow Quality and Patterns.................................................... 8
Construction, Plant Improvement, Maintenance Projects........... 8
Table
of Contents
Sanitary Design of Equipment & Utensils............... 9
General................................................................................ 9
Equipment and Infrastructure........................................... 10
Utensils ............................................................................ 10
Food Contact Surfaces .................................................... 10
Cleaning, Sanitation, and Maintenance Practices ... 11
General .............................................................................. 11
Pre-operative Sanitation ...................................................... 11
Operative Sanitation............................................................... 12
Grounds .................................................................................... 13
Maintenance.................................................................................. 13
Environmental Monitoring Considerations........................ 14
Environmental Sample Collection and Handling...................................... 14
Water Use in the Production Area................................................ 15
Water Supply............................................................................................................ 15
Water Control ....................................................................................................................... 15
Good Manufacturing Practices and Personal Hygiene..................................................... 15
Employee Training ............................................................................................................................................. 15
Good Manufacturing Practices.......................................................................................................................... 16
Personal Hygiene............................................................................................................................................... 17

Part 2: Control Strategies for High Care Frozen Vegetable Operations .................................. 18
Sanitary Design of Facilities and Amenities........................................................................... 18
Facility Design ................................................................................................................................................... 18
Traffic Patterns................................................................................................................................................... 19
Fixtures .............................................................................................................................................................. 19
Air Flow Quality and Patterns ............................................................................................................................ 19
Water Systems................................................................................................................................................... 20
Sanitary Design of Equipment and Utensils........................................................................... 21
Equipment and Infrastructure............................................................................................................................ 21
Utensils.............................................................................................................................................................. 22
Cleaning and Sanitation Practices......................................................................................... 23
General .............................................................................................................................................................. 23
Pre-operative Sanitation.................................................................................................................................... 23
Operative Sanitation .......................................................................................................................................... 24
Environmental Monitoring Considerations ........................................................................................................ 25
The Environmental Monitoring Plan................................................................................................................... 25
Sample Collection ............................................................................................................................................. 26
For Cause Investigation..................................................................................................................................... 27
Not For Cause Investigation .............................................................................................................................. 28
Water Control in the Production Area .................................................................................... 28
Good Manufacturing Practices and Personal Hygiene ........................................................... 30
Personal Hygiene............................................................................................................................................... 30
Raw Materials and Other Ingredients Good Manufacturing Practices .............................................................. 31
Listericidal Process Control............................................................................................................................... 32
Other Good Manufacturing Practices................................................................................................................ 32
Appendix I. FDA Investigations Resources............................................................................. 33
References............................................................................................................................ 34
3

Food Northwest Frozen Vegetable Workgroup
Debbie Radie, Boardman Foods
Todd Badgley, Lamb Weston
Robert Beck, NORPAC Foods
Amanda Pederson, NORPAC Foods
Mark Hooper, Pinnacle Foods
Mark Clute, Rainsweet Co.
Larry Mulenberg, Seneca Foods
Kevin Browning, J.R. Simplot Co.
John O’Grady, Twin City Foods
Glenn Strachan, Twin City Foods
Connie Kirby, Food Northwest
David McGiverin, Food Northwest
Definitions
Food Contact Surfaces (FCS) – A surface in the post-lethality processing environment that comes in direct
contact with product.
High-Care Area – An area designed to a high standard where practices relating to personnel, ingredients,
equipment, packaging, and environment aim to minimize product contamination by pathogenic microorganisms
(BRC Global Standard for Food Safety Issue 7).
High-Care Food – A food product that requires chilling or freezing during storage, is vulnerable to the growth
of pathogens, received a process to reduce the microbiological contamination to safe levels (typically 1-2 log
reduction), and is ready to eat or heat (BRC Global Standard for Food Safety Issue 7).
Lethality Step – A process that eliminates or reduces the number of pathogenic microorganisms on or in a
product to make the product safe for human consumption. Examples of lethality treatments are cooking or the
application of an antimicrobial agent or process, that eliminates or reduces pathogenic microorganisms.
Preventive Controls Qualified Individual (PCQI) – A qualified individual who has successfully completed
training in the development and application of risk-based preventive controls at least equivalent to that received
under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job
experience to develop and apply a food safety system (21 CFR 117.3).
4

Introduction
This checklist was developed to assist frozen vegetable manufacturers in conducting a comprehensive audit of
control measures for Listeria monocytogenes (Lm) in their operations. It is designed to correspond as a
checklist to the principles laid out in “Best Practices for Prevention and Control of Listeria monocytogenes in
the Post-Lethality Environment.” developed by FNW collaborative partner, the American Frozen Food Institute.
It is based on the current science available at the time of publication. As research in Lm control in food processing
facilities is expanding rapidly, readers should expect this document to evolve as best practices develop.
The document was created in an internal audit format. It is comprised of a comprehensive set of questions,
developed by industry food safety professionals, that a firm can be asking about Listeria control measures
employed in their facility. However, as firms must tailor their food safety systems to each facility, not all the items
in the checklist may apply to all firms. It is important for each item to be evaluated with respect to the Lm
hazards present in their operation. A ‘Notes’ section is included at the end of each section to assist in collecting
details about observations.
Part 1 of this checklist is for facilities that are producing product that is designed to have a kill step before
consumption. It includes basic Listeria control practices for all frozen vegetable operations to consider implementing.
Many of the elements implied by the questions are required by United States regulations.
Part 2 is for facilities that are producing product that is not expected to have a kill step prior to consumption.
Firms should individually evaluate their market objectives when employing this section. Many of the elements
implied in these questions are consistent with current Food and Drug Administration guidance for Lm control in
ready-to-eat foods issued 2017. This section is designed to be used in addition to Part 1, thus the sections in
this part do not contain basic control strategies.
This checklist is intended as general guidance to assist facilities in developing Lm controls tailored to
their specific activities. It is not intended, nor should it be used, as legal advice. Facilities are encouraged
to seek independent regulatory counsel to ensure compliance with applicable requirements.
5

Part 1: Basic Listeria
Control Strategies for Frozen
Vegetable Processing
This part includes internal audit questions designed to prompt analysis of Listeria
control strategies for operations producing frozen vegetable products that are expected
to have an additional lethality step prior to consumption. These questions reflect a
combination of industry best practices and current requirements under 21 CFR Part 117.
Sanitary Design of Facilities and Amenities
General
◦ Has someone with expertise in sanitary design been an integral part of the facility/equipment
design team?
◦ Has the PCQI or his/her designee signed off on the sanitary design of the facility and amenities?
◦ Is sanitary design the top priority in facility/equipment design?
◦ Is financing for the building/remodeling and equipping of the facility adequate to achieve the desired
level of food safety?
Grounds
◦ Do the grounds have adequate drainage?
◦ Are the grounds landscaped to prevent harborage of pests or contamination of air supplies coming
into the facility?
6

Facility
◦ In the production areas, is there sufficient space provided to enable sanitary operation, effective
maintenance, and cleaning activities?
◦ Are there adequate storage facilities for equipment, supplies, raw materials and other ingredients,
and product?
◦ Is semi-finished food (vinegar, sugar syrup, oil, etc.) stored in outdoor bulk facilities adequately
protected from contamination by pests, dirt or other filth?
◦ Is the roof designed and constructed so that it drains freely and does not leak?
Walls, Floors and Drainage, Ceilings
◦ Are floors, walls, and ceilings of such construction as to be adequately cleanable and kept in
good repair?
◦ Are floors of such material as to be smooth and non-porous to prevent harborage of Listeria?
◦ Are floors and drains designed to facilitate good drainage and prevent standing water?
Traffic Patterns
◦ Is the flow of product and people compartmentalized throughout, separating raw materials from
finished products?
◦ Is the post-lethality environment isolated from the rest of the facility?
◦ Are traffic patterns for workers, management, visitors, consultants, etc. well defined to prevent
contamination of post-lethality product?
◦ Are aisles or working spaces adequate to permit movement of workers, tools, and equipment
without potential for contamination?
Fixtures, Ducts, Plumbing, Lighting
◦ Are fixtures, ducts, and pipes designed and installed in such a manner that drips or condensate do not
contaminate foods, raw materials, food-contact surfaces, or packaging materials?
◦ Are air return ducts for HVAC or air makeup units accessible and capable of being cleaned
and inspected?
◦ Is plumbing of adequate size and design and adequately installed and maintained to carry adequate
quantities of water to required locations throughout the plant?
7

◦ Does the plumbing properly convey sewage and liquid disposable waste from the plant?
◦ Is the plumbing designed so as not to constitute a source of contamination to food, water supplies,
equipment, or utensils or create an unsanitary condition?
◦ Is there adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where
normal operations release or discharge water or other liquid waste on the floor?
◦ Does the plumbing provide that there is not backflow from, or cross-connection between, piping
systems that discharge waste water or sewage and piping systems that carry water for food
or food manufacturing?
◦ Is sewage disposed of by means adequate to prevent contamination?
◦ Are there adequate, readily accessible toilet facilities?
◦ Are there hand-washing facilities designed to ensure that an employee’s hands are not a source of
contamination of food, food-contact surfaces, or food-packaging materials?
◦ Are all hand washing stations, lavatories, cafeterias, and locker room facilities properly designed such
that they can be cleaned and maintained in a sanitary manner?
◦ Are rubbish and waste disposal systems designed such that rubbish and waste can be conveyed,
stored, and disposed of so as not become an attractant for pests, or otherwise contribute
to contamination?
◦ Is there adequate screening or other protection against entrance of pests into the facility?
◦ Is there adequate lighting provided in all areas?
◦ Is the lighting shatter proof and placed such that it doesn’t contribute to contamination?
Air Flow Quality and Patterns
◦ Is there adequate temperature and humidity control to prevent condensate build-up and growth
of Listeria?
◦ Is air flow and quality designed to prevent introduction or recirculation of Listeria into or around
the facility?
Construction, Plant Improvement, Maintenance Projects
◦ During construction, plant improvements, and/or maintenance, is a food safety plan in place for those
special circumstances to prevent contamination?
8

◦ Are physical and visual barriers present to separate the construction zone from food processing areas
and exposed product?
◦ Is the pathway for debris removal contained to prevent contaminating other areas?
◦ If food traffic is to be rerouted, are handwashing, gowning, and footbath stations in convenient locations
to support the temporary traffic flow?
◦ Are contractors observing standard GMP requirements (hairnets, smocks, footwear, etc.)?
◦ Is the post-construction plan for dust and debris removal, sanitation, etc. adequate to prevent
contamination of product when production resumes?
◦ Has the post-construction sanitation been adequately verified by environmental monitoring before
resumption of production?
◦ Has new equipment been adequately cleaned and verified to prevent contamination of product?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Sanitary Design of Equipment & Utensils
General
◦ Are equipment and utensils designed and of such material and workmanship as to be adequately
cleaned, inspected, and properly maintained to prevent contamination?
◦ Are holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and
automated systems, of a design and construction that enables them to be maintained in an appropriate
clean and sanitary condition?
◦ Do equipment and utensils meet design standards such as 3A Sanitary Standards Inc. (3A SSI),
European Hygienic Design Group (EHDG), or National Sanitation Foundation International (NSF) or
other recognized standards?
◦ Is a sanitary design expert and/or qualified microbiologist consulted before purchasing and installing
equipment or utensils?
◦ Has the PCQI or his/her designee signed off on the sanitary design of the equipment and utensils?
9

Equipment and Infrastructure
◦ Is equipment sufficiently raised over the floor to allow access for cleaning and water
drainage underneath?
◦ Is equipment otherwise installed to facilitate cleaning and maintenance?
◦ Where catwalks are necessary, are they enclosed and with adequate kick plates such that surfaces
beneath them won’t be contaminated with debris or water?
◦ Is the framework of catwalks of solid construction so as not to accumulate water or debris?
◦ Are instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity,
water activity, or other conditions that control or prevent the growth of undesirable microorganisms in
food accurate, precise, and adequately maintained, and adequate in number for their designated uses?
Utensils
◦ Are floor mats of adequate design so as not to become harborage sites for pathogens?
◦ Are utensils and portable equipment color coded for differentiating use in raw versus processed
product areas?
Food Contact Surfaces
◦ Are food contact surfaces made of non-toxic, corrosion-free material?
◦ Are food contact surfaces designed to withstand the environment to which they will be subjected?
◦ Are seams on food-contact surfaces smoothly bonded and maintained to minimize accumulation of food
particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms?
◦ Are conveyors easily accessed for cleaning and inspection?
◦ Are the rollers solid and without harborage points?
◦ Do roller lubricants contain a listeriocidal agent?
◦ Are compressed air or other gases mechanically introduced into food or used to clean food-contact
surfaces or equipment treated in such a way that food is not contaminated?
◦ Are continuous use brines discarded or decontaminated sufficiently to control Listeria monocytogenes?
10

Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Cleaning, Sanitation, and Maintenance Practices
General
◦ Is the overall sanitation of the plant under the supervision of one or more competent individuals
on all shifts?
◦ Do you have comprehensive written procedures for pre-operative and operative sanitation?
◦ Are sanitation procedures validated for effectiveness in removing Listeria?
◦ Are all written procedures routinely monitored and documented on all shifts?
◦ Where corrective actions/activities are needed, are these followed up on and documented?
◦ Are quality control operations appropriate to verify monitoring and documenting on all shifts?
◦ Is there adequate time between production runs for sanitation procedures to be accomplished
effectively enough to ensure adequate cleaning that prevents niches of Listeria from establishing
in the facility?
Pre-operative Sanitation
◦ Is all extraneous material, such as food residues, dirt and soil removed from the facility prior
to cleaning?
◦ Is the facility pre-rinsed and inspected for problem areas that may need more attention?
◦ Is the facility adequately cleaned and sanitized as directed by one or more experts in food
facility sanitation?
◦ Are effective chemicals or techniques used at the correct dilution, application time and temperature,
mechanical force, etc.?
◦ Is high-pressure application of water avoided to prevent atomization of Lm?
11

◦ Is the facility assessed for the effectiveness of the sanitation activities through an adequate combination
of inspection procedures, including routine microbiological and chemical testing, such as ATP, as well as
thorough visible examination?
◦ Where problems are revealed through inspection, are these areas recleaned, sanitized and reinspected
prior to start-up?
◦ Is excess water removed from equipment, floors, etc.?
◦ If necessary, are food contact surfaces thoroughly dried before start-up?
◦ Are floor drains cleaned adequately to prevent spread of Listeria?
◦ Are tools dedicated and appropriately designed for this purpose only?
◦ Are sanitation tools, supplies and equipment stored clean and dry in a sanitary location to prevent
Listeria growth?
◦ Are sanitation supplies verified free from Listeria through letters of guarantee or certification, and/or
verified by suitable examination?
◦ Is equipment that is newly installed or reinstalled after maintenance thoroughly disassembled, cleaned,
and sanitized before installation?
◦ Is freezing equipment thoroughly cleaned and sanitized frequently enough to prevent
cross-contamination with Listeria?
◦ Are toilet facilities adequately cleaned before and during operation of the facility?
Operative Sanitation
◦ Is the use of water for operational sanitation minimized, particularly with high-pressure hoses?
◦ Is the accumulation of standing water on equipment and floors prevented?
◦ Are there appropriate operative sanitation controls to minimize or prevent the spread of Listeria due to
employee handling?
◦ Are non-food-contact surfaces of equipment cleaned in a manner and as frequently as necessary to
protect against contamination of food, food-contact surfaces, and food-packaging materials?
◦ Are all food-contact surfaces cleaned and sanitized after any interruption during which the food-contact
surfaces may have become contaminated?
◦ Where equipment and utensils are used in a continuous production operation, are they cleaned and
sanitized as necessary?
12

◦ Are single-use articles stored, handled, and disposed of in a manner that protects against contamination?
◦ Is food that has become contaminated rejected, stored, and handled in a way that it does not
cross-contaminate other food?
Grounds
◦ Are the grounds around the facility maintained in a manner that will prevent the possibility of food
adulteration from pests, air contamination, foot traffic into the facility, etc.?
◦ Is litter and waste removed and weeds or grass kept cut down?
◦ Are areas where water accumulates kept drained?
◦ Are the areas around wet and/or dry waste or scrap compactors, modules, and dumpsters kept clean
and in good repair?
◦ Are the roads, yards, and parking lots free from dust, standing water, or other potential contaminants
that could introduce contaminants into the facility?
◦ Where sources of contamination occur on property not owned by the company, are adequate measures
taken to prevent pests, dirt, filth, etc. from becoming a source of food contamination?
Maintenance
◦ Is there an overall maintenance program that is designed to maintain buildings, fixtures, and physical facilities
in a clean and sanitary condition, and repaired adequately to prevent food from becoming adulterated?
◦ Is there regularly scheduled maintenance and cleaning of HVAC and air systems?
◦ Is there a preventive maintenance program that catches and fixes corroded, cracked, or damaged
equipment or utensils?
◦ Are maintenance and preventive maintenance programs monitored for compliance?
◦ If there is an equipment “boneyard,” is it maintained sufficient to prevent contamination?
◦ Are waste treatment and disposal systems operated in a manner to prevent contamination?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
13

Environmental Monitoring Considerations
◦ Do management policies encourage environmental monitoring practices that seek to find and eradicate
transfer and harborage sites for Listeria in the facility?
◦ Is there a written environmental monitoring plan?
◦ Is the plan tailored to the facility, product, and process?
◦ Is the plan prepared by a PCQI with an objective to seek out transfer points and harborage sites and
destroy them?
◦ Are there environmental monitoring procedures for verification of pre-operative sanitation effectiveness,
as well as operative procedures to verify protection against contamination during food production?
◦ Are good sampling procedures employed in the collection and handling of samples?
◦ Is the plan directed toward detection of indicator organisms in the environment, such as Listeria species?
◦ When positive tests are found, is a root cause investigation conducted to find the source of the problem?
◦ Is the problem corrected and retested to verify correction?
◦ Is the corrective action documented exactly as it occurred, no more or less?
Environmental Sample Collection and Handling
◦ Are there science-based written procedures for collecting, handling, and analyzing environmental samples?
◦ Are procedures followed in the collection of environmental samples?
◦ Are samples properly handled prior to delivery to the laboratory?
◦ Are samples properly stored prior to analysis?
◦ Is sample analysis conducted and documented in a timely fashion?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
14

Water Use in the Production Area
Water Supply
◦ Is the water supply adequate for its intended use?
◦ Is running water at a suitable temperature and under pressure, as needed, for processing of food, for
cleaning of equipment, utensils, and food packaging materials, or for employee sanitary facilities?
◦ Do municipal water supplies meet EPA Standards for safe water?
◦ If applicable, is an annual municipal water report maintained on file?
◦ Is process water tested semiannually for potability?
◦ If using well water, is it tested with sufficient frequency to ensure compliance with water
quality standards?
Water Control
◦ Is reclaimed or recirculated water treated to eliminate Listeria?
◦ Is the use of pressurized water in the production area limited or eliminated to prevent atomization
of Listeria?
◦ Are handwashing facilities located away from production lines to prevent splashing onto equipment?
◦ Are floors and drains maintained to prevent standing water?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Good Manufacturing Practices and Personal Hygiene
Employee Training
◦ Are all employees trained on GMP and personal hygiene procedures appropriate to their roles
and responsibilities?
15

◦ Are training verification methods, such as testing, observation, etc., used to make sure employees have
learned and retained these trainings?
◦ Are employees retrained with frequency adequate to maintain safe food handling practices?
Good Manufacturing Practices
◦ Is traffic flow in the facility controlled to minimize movement of people from raw to finished and in
between without appropriate interventions?
◦ Are raw materials cleaned and rendered suitable for processing into food and stored under conditions
that protect against contamination?
◦ Are raw materials, rework and ingredients held in containers designed and constructed and at
temperature/humidity to protect against contamination?
◦ Is rework identified as such?
◦ Is rework and work in-process handled in a manner that protects against contamination and/or growth
of Listeria?
◦ Where thawing is not necessary for use, are frozen vegetables and ingredients kept frozen?
◦ For ingredients that support the growth of Listeria, are they held at temperatures that prevent them from
growing Listeria during manufacturing, processing, packing, and holding?
◦ Is finished product held in a manner to protect against contamination by raw materials, other
ingredients, refuse or other materials?
◦ Is contaminated product disposed of in a manner that protects against contamination of other
food products?
◦ If contaminated product is to be reconditioned, is a method used that has been proven to be effective?
◦ Is food transported and stored in a manner to protect against contamination?
◦ Are transportation vehicles adequately equipped to control and monitor the temperature of incoming
ingredients and outgoing finished food products appropriately to avoid the growth of Listeria?
16

Personal Hygiene
◦ Do personnel working in direct contact with food, food contact surfaces and/or food packaging
materials maintain adequate personal cleanliness?
◦ Do personnel wash their hands thoroughly in adequate facilities before starting work, after breaks and at
any other time when their hands may have become soiled?
◦ Do personnel remove or cover jewelry which may result in contamination?
◦ If appropriate to their job, are employees provided with clean, undamaged gloves, smocks, aprons?
◦ Are smocks or aprons color coded according to the areas where they work (e.g., to prevent
cross-contamination between raw and cooked products)?
◦ When gloves are worn, are they maintained in an intact, clean, and sanitary condition at all times?
◦ Are soiled clothes washed and not left around to create contaminated transfer points?
◦ Is footwear worn by employees and visitors of such construction to allow effective cleaning?
◦ Is such footwear cleaned sufficiently to prevent it from becoming a source of contamination in
the facility?
◦ Are personnel instructed to report such conditions as illness, open lesions, or other abnormal sources of
microbial contamination to their supervisor or appropriate management personnel?
◦ Are any such personnel restricted from food handling operations or otherwise containing sources of
contamination, such as through the use finger cots or similar devices?
◦ Where appropriate, are hair nets, beard covers, and other hair restraints worn in an effective manner?
◦ Are activities such as eating, chewing gum, drinking beverages, or using tobacco confined to clean,
designated non-processing areas of the facility?
◦ Do personnel take any other necessary precautions to prevent contamination from things such as
perspiration, hair, cosmetics, tobacco, chemicals, and medications applied to the skin?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
17

Part 2: Control Strategies
for High Care
Frozen Vegetable Operations
This part includes questions about Listeria control strategies for operations producing
frozen vegetable products that are not expected to have an additional lethality step
prior to consumption. This section is designed to be inclusive of Part 1 items.
Where appropriate, guidance from FDA and others has been included in footnotes.
However, the references to ready-to-eat guidance are not meant to imply that
following this checklist will provide ready-to-eat product, nor are the references
intended to conclude whether products may be considered ready-to-eat or not
ready-to-eat.
Sanitary Design of Facilities and Amenities
Facility Design
◦ Are the facility structures of suitable size, construction, and design to facilitate maintenance and sanitary
operations for food production purposes?
◦ For new construction or renovation, is the plant designed and constructed to reduce the potential for
contamination of high care foods via air, aerosols, or traffic of personnel or equipment?
◦ Is the plant designed and constructed to create effective physical barriers which separate post-lethality
areas from areas where raw foods are processed, exposed, or stored, and from equipment washing
areas, microbiological laboratories, maintenance areas, waste areas, offices, and toilet facilities?
18

◦ Is the plant designed and constructed so that walls, ceilings, windows, doors, floors, drains, and
overhead fixtures (e.g. pipes, air vents, and lights) in areas where high care foods are processed or
exposed are accessible for cleaning, resist deterioration by product or cleaning chemicals, and
prevent condensation and harborage of microorganisms?
◦ Are openings to the outside, such as windows that open, vents, etc., eliminated from the high care area?
◦ Are construction materials which do not harbor microorganisms, used in areas where high care foods are
processed or exposed and in other wet processing areas in the facility?
◦ During renovation projects, are temporary barriers erected to isolate the construction from the rest of the
facility, traffic patterns revised, cleaning and sanitizing enhanced, and environmental monitoring
enhanced?
◦ Are the appropriate controls in place to isolate microbiological laboratories from processing areas and
infrastructure (water, air supplies, etc.), preferably in another building, and prevent contamination of
products and processes?
Traffic Patterns
◦ Is traffic restricted to the post-lethality area from other areas prior to the lethality process?
◦ Is traffic to the post-lethality area restricted to appropriate personnel?
◦ Are traffic flow patterns for people, food products, food packaging materials, and equipment directed to
minimize the potential for transfer of Listeria monocytogenes between areas where raw foods are
processed or exposed and areas where high care foods are processed or exposed?
Fixtures
◦ Are appropriate foot sanitizing systems (wet or dry) used when entering areas where high care foods are
processed or exposed?
◦ If non-automatic foot sanitizing systems are used, are they checked at regular intervals, such as hourly,
to ensure that they are filled with sanitizer, that the sanitizer is diluted to the proper concentration, and
that the spray pattern, if applicable, is sufficient to be effective?
Air Flow Quality and Patterns
◦ Has an individual with appropriate engineering skills determined how to achieve proper air balance and
the desired air exchange rate, including determining the number, size, and location of intake and exhaust
fans, room temperature and the impact on condensation?
19

◦ In designing the air flow in your plant, is positive air pressure maintained on the high care side of the
operation relative to the "raw" side (i.e., maintain higher air pressures in high care areas and lower air
pressures, even negative pressure, in raw areas)?
◦ To avoid contamination of intake air, is the location of the air intake removed from the location of the air
exhaust or other sources of airborne contamination such as waste disposal areas?
◦ Is the air filtered to the appropriate particle size?
◦ Is there appropriate air pressure in specific zones of the plant, e.g., negative in raw material, positive in
post-lethality?
Water Systems
◦ Is the plant designed and constructed in such a manner that drip or condensate from fixtures, ducts and
pipes does not contaminate food, food contact surfaces, or food packaging material?
◦ Are drains designed and constructed to function adequately?
◦ Are drains designed and constructed to be accessible for cleaning?
◦ Are trench drains eliminated from the high care area, or replaced with enclosed plumbing to a
floor drain?
◦ Are drains designed and constructed so that they do not flow from areas where raw foods are processed
or exposed to areas where high care foods are processed or exposed?
◦ Are restroom drains designed and constructed so they are not connected to drains serving high
care areas?
◦ Are floors designed and constructed with appropriate slope so that floors drain freely, and water or
waste does not accumulate?
◦ Are sewer lines located such that they are not above where high care foods, food contact surfaces, or
food packaging materials are processed or exposed?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
20

Sanitary Design of Equipment and Utensils
Equipment and Infrastructure
◦ Is equipment that you purchase and use to process high care foods designed and constructed to
facilitate cleaning and to minimize sites where microbial harborage and multiplication can occur?
◦ Has a person qualified in sanitary design of food processing equipment reviewed the design of
equipment to be installed, regardless of whether the equipment is new or existing, including existing
equipment that is being modified?
◦ Is one set of equipment (such as carts, forklifts, mobile racks, and pallets) dedicated to the area where
high care foods are processed or exposed?
◦ If it is impractical to dedicate one set of equipment to the high care areas, is the equipment cleaned and
sanitized, including wheels and other areas that could potentially be transfer points, before they enter an
area where high care foods are processed or exposed?
◦ Are food-contact surfaces smooth, non-absorbent, sealed, easily cleanable, sloped to drain freely, and
made of durable, non-corrosive and non-toxic materials?
◦ Are control panels designed and sealed to prevent harborage of pathogens?
◦ Are bolts, studs, mounting plates, brackets, junction boxes, name plates, end caps, sleeves and other
such items continuously welded to the surface of the equipment?
◦ Are welds and other connections smoothly bonded (e.g., free of pits, folds, cracks, crevices, open
seams, cotter pins, exposed threads, and piano hinges) with junctures that are covered?
◦ Are hollow areas of equipment (e.g., frames, rollers) eliminated, where possible, or permanently sealed,
if not?
◦ Is piping used to convey high care foods free of dead ends or cross-connections between raw and high
care foods?
◦ Is equipment, such as catwalk framework, table legs, conveyor rollers, and racks, designed and
constructed so that they cannot collect water that could harbor Listeria monocytogenes (e.g. not hollow
or foam filled)?
◦ Do ladders and stairs in areas where high care foods are processed or exposed have plating underneath
that prevents any debris from shoes or other items from personnel who are using them from falling onto
the processing line?
◦ Do these plates have up-turned edges so that debris that falls onto the plates cannot roll off and onto
the lines?
◦ Are catwalks and stairs with open grating positioned such that they are not over exposed high care
food or food-contact surfaces?
21

◦ Is stationary equipment used to process high care foods installed such that it is not over floor drains that
could splash and contaminate the food?
◦ Are food contact surfaces of stationary equipment (including conveyors) used to process high care
foods sufficiently elevated above the floor to prevent contamination by floor splash?
◦ If overhead conveyors cannot be avoided, are they designed to be easily accessible for cleaning?
◦ Are overhead conveyors designed and constructed in such a manner that drip or condensate does not
contaminate high care food, food contact surfaces or food packaging materials?
Utensils
◦ Are only pallets that can easily be cleaned and kept in good condition used in high care areas?
◦ Are dedicated tools for the high care area separate from tools in other parts of the plant?
◦ If separate tools are not practical, are tools cleaned and sanitized prior to entering the high care area?
◦ Are equipment and utensils that are uniquely color coded for the high care area used in the high care
area only?
◦ Are containers in high care areas designated by function (e.g., product, rework, or waste) and clearly
distinguished from each other?
◦ Are the wheels of racks used for transporting exposed high care foods covered with cleanable guards
over them to prevent contaminations of high care foods and food contact surfaces from wheel spray?
◦ Are listeriocidal substances (e.g., sodium benzoate) added to lubricants (e.g., chain, valve, and seal
lubricants) so that the lubricants do not become contaminated with product residue and, thus, become a
niche for Listeria monocytogenes?
◦ Are tools intended for maintenance of equipment used in areas where high care foods are processed or
exposed dedicated to those areas?
◦ Are wipes disposable and discarded after each use on high care food-contact surfaces?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
22

Cleaning and Sanitation Practices
General
◦ Is there a written sanitation program established and in use that includes the condition and cleanliness
of FCSs, the prevention of cross-contamination, procedures for cleaning equipment and floors, and the
steps for all cleaning operations
◦ Is the written sanitation program readily available to personnel who are responsible for cleaning?
◦ Are sanitation procedures monitored for adherence to the written sanitation program?
◦ Are corrections or corrective actions applied and documented appropriately?
◦ Is cleaning and sanitizing done with sufficient frequency to ensure control of Lm and to minimize
conditions that promote the survival or multiplication of Lm in the environment?
◦ Are sanitizers used that have regulatory approval for the intended purpose, are effective against the
target organism, and effective under conditions of use?
◦ Are sanitizers rotated for greater long-term effectiveness?
◦ Have you assessed the sanitary design of current equipment in high care areas using your sanitation
program to address needs for hygienic restoration?
Pre-operative Sanitation
◦ Do you verify and document on a regular basis that your actual cleaning, sanitizing and inspection
procedures match those specified in your written sanitation procedures?
◦ Are sanitation control records established and maintained that document corrections or corrective
actions of monitored sanitation conditions and practices that are not implemented in accordance with
your written sanitation program?
◦ Are pallets and wheels of transport equipment (e.g., carts, forklifts, and mobile racks) cleaned and
sanitized before they enter an area where high care foods are processed or exposed?
◦ Are filters used on intake air examined and changed either at a frequency based on the manufacturer's
specification or more frequently based on pressure differential or the results of environmental monitoring?
◦ Are equipment and tools in food contact areas maintained such that they do not become a source
of contamination?
◦ Are equipment and food-contact surfaces used in areas where high care foods are processed or
exposed cleaned and sanitized after maintenance and prior to use in production?
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◦ Is equipment that could become contaminated as a result of maintenance on facility utilities (e.g., air or
water systems) or remodeling cleaned and sanitized prior to use?
◦ When assembling cleaned and sanitized equipment (e.g., pump impellers, pipes), are equipment parts
placed on cleaned and sanitized surfaces and kept off the floor?
◦ Is water from the floor or unclean equipment prevented from splashing onto the clean equipment?
◦ Is equipment used for cleaning (e.g., hoses, ladders, gear, brushes, mops, floor scrubbers, reusable
towels, and vacuum cleaners, etc.) maintained and cleaned so that it does not become a source
of contamination?
◦ If you are using disposable wipes, are they discarded after each use on food contact surfaces?
◦ When scouring pads are not in use during the day, are they kept dry or placed in a sanitizer solution?
◦ Are scouring pads discarded frequently?
◦ Are evaporation drain hoses properly cleaned, sanitized, and monitored?
◦ Are steam, hot water, chlorine dioxide or other innovative cleaning techniques considered for sanitizing
equipment that is difficult to clean or needed to address harborage sites for Lm?
Operative Sanitation
◦ Are sanitation conditions and practices during processing monitored with sufficient frequency to ensure
the cleanliness of food-contact surfaces and prevent cross-contamination?
◦ Are sanitation conditions, cleanliness and practices that are not implemented in accordance with the
sanitation program corrected in a timely manner?
◦ Is use of pressurized water avoided during production in high care areas?
◦ Is washing of equipment avoided during times where high care foods or packaging materials are
exposed in the area?
◦ Do procedures for wet cleaning and sanitizing of equipment ensure that equipment other than that being
cleaned are not being compromised?
◦ Is exposed high care food or packaging removed from the room, including coolers or freezers, before
beginning any wet cleaning of equipment, floors, and other areas?
◦ Are cleaning activities conducted in such a way as to not create drain backups in floor drains?
◦ Do you avoid cleaning and sanitizing a line when other lines are running in the same room?
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◦ If cleaning and sanitizing a line is necessary when another line is running in the same room, are
precautions taken to contain or eliminate overspray, condensation, drain backups, room temperature,
humidity, air pressure, adverse traffic patterns?
◦ Are sinks or washing areas located away from product or product contact surfaces to prevent splashing
Listeria-contaminated water?
◦ Are pallets in areas where high care foods are processed or exposed inspected, cleaned, and in overall
good condition such that they do not serve as a source of contamination?
◦ Are cleanable, non-porous pallets used (as opposed to wooden) in high care areas?
◦ Is brine or recycled process water that is used in direct contact with high care foods discarded or treated
with sufficient frequency and effectiveness to prevent Lm contamination?
◦ Is compressed gas or air used directly in or on high care foods, food contact surfaces or food packaging
materials treated and inspected to make sure it is not a source of contamination?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Environmental Monitoring Considerations
The Environmental Monitoring Plan
◦ Is a written plan established and implemented for the collection, analysis, and evaluation of
environmental samples from critical surfaces and areas?
◦ Is the plan scientifically validated?
◦ Does the plan specify whether you are testing for Listeria species or Listeria monocytogenes?
◦ Does the plan evaluate each plant, product, and process to determine the appropriate
monitoring points?
◦ Does the plan identify the locations from which samples will be collected and the number of sites to be
tested during routine environmental monitoring?
◦ Does the plan include plant blueprints with designation of zoned areas?
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◦ Is the zoning consistent with current regulatory and industry best practices (including floors, walls,
ceilings of the freezer)?
◦ Does the plan include sample collection during pre-operative inspection, as well as key
operational times?
◦ Does the plan identify the timing and frequency for collecting and testing samples?
◦ Is the timing and frequency for collecting and testing samples adequate to determine whether Listeria
control measures are effective?
◦ Does the plan identify the tests conducted, including the analytical method(s) used?
◦ Does the plan identify the laboratory being used to conduct the testing?
◦ Has the laboratory been accredited?
◦ Does the plan include instruction for increased intensity of sampling for planned events (construction,
major repairs, equipment installation, etc.)?
◦ Does the plan include instructions for responding to unplanned events (water leaks, major hygienic
zones breach, fires, etc.)?
◦ Does the plan use screening tests for the presence of Listeria species to identify harborage sites
more rapidly?
◦ Does the plan include directions for corrective actions or preventive measures when a positive
sample is found?
◦ Does the plan include instructions for documentation of sample collection, handling, and results?
◦ Are results reviewed for trends that could indicate developing problems before product
becomes implicated?
◦ Is your written plan periodically verified with increased and intensive environmental sampling
(a ‘swabathon’) to assess whether the sampling sites are appropriate?
Sample Collection
◦ Are samples collected and handled according to established industry procedures?
◦ Are samples tested using recognized methodology?
◦ Is the sample size representative of the process and the plant history of control?
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◦ If you test a representative set of samples (rather than all samples) each time, is the plan for sample
collection and testing designed so that all critical non-food-contact surfaces are tested at least once
each quarter?
◦ Are the sample sites selected with the goal of finding transfer and harborage sites for Listeria, including
high traffic areas and/or high moisture sites?
◦ Are the sites of sample collection varied on a rotating basis, particularly where there are predominantly
negative results?
◦ When food contact surfaces are sampled during a pre-operative inspection, is the equipment cleaned
and sanitized again prior to beginning production?
◦ Are results reviewed in a timely fashion, such that any positive result is responded to as soon
as possible?
◦ Are results reviewed for trends that could indicate developing problems before product
becomes implicated?
◦ Does trend analysis of test results aim to continuously improve sanitation conditions in the plant by
reducing the percentage of overall positive environmental samples?
◦ When testing on Zone 1 surfaces, are appropriate procedures in place to prevent distribution of product
into commerce?
For Cause Investigation
◦ Is the investigation initiated as soon as possible after screening tests indicate positive results without
waiting for confirmation of Listeria monocytogenes?
◦ When positive Listeria species are found, is an analysis done to determine if the site is a transfer point or
harborage site?
◦ If the positive sample is determined to have come from a harborage site (or growth niche), has an
analysis been done that reveals the root cause of the contamination?
◦ Where a positive test result is found in Zone 1, is finished product evaluated for contamination?
◦ If a positive Listeria species test result is found, is the area around the positive site cleaned, sanitized,
and retested during the next production cycle?
◦ If the retest of the positive Listeria species test result is also found to be positive, is an intensified
cleaning, sanitizing, sampling, and testing conducted, e.g., vector sampling?
◦ If a third positive Listeria species test result is found in the same area, is a root cause analysis
conducted, followed by escalated mitigation efforts and consideration of outside consultation?
◦ Are all corrective actions recorded and maintained?
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Not For Cause Investigation
◦ Is environmental monitoring used to validate levels of disassembly for normal and periodic enhanced
sanitation procedures?
◦ Is new equipment, equipment brought from storage, or equipment new to a high care area evaluated for
an effective pre-operative sanitation procedure at installation and at appropriate intervals for up to 90
days after installation?
◦ Is environmental monitoring used to measure the effectiveness of hurdles and barriers in the process?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Water Control in the Production Area
◦ Are water treatment systems maintained and inspected to ensure that they do not become a source of
microbial contamination?
◦ Are ice and ice utensils handled and stored in a manner that protects ice from microbial contamination?
◦ Do employees refrain from using high-pressure water hoses in areas where high care foods are
processed or exposed during production or after equipment has been cleaned and sanitized?
◦ In a high care area where wet cleaning of equipment (e.g., down lines, storage and spiral coolers, and
spiral freezers) is allowed, is the risk of aerosolization controlled where high care food is exposed?
◦ If wet cleaning is allowed, is all exposed high care food removed from the room before beginning any
wet cleaning of equipment, floors, etc.?
◦ If wet cleaning is allowed, is the process monitored and verified that contamination is
adequately prevented?
◦ Is all exposed high care food removed from a cooler prior to cleaning the cooler, refrigeration condenser
units, or condensate drip pans and hoses?
◦ Are hoses and hose nozzles kept off the floor or other unclean surfaces in high care areas?
28

◦ Are floor drains cleaned and sanitized in a manner that prevents contamination of other surfaces in the room?
◦ Are water systems adequately designed, installed, and maintained to prevent backflow and
cross-connections between potable and non-potable water lines or systems?
◦ Are back flow devices installed in all drains to prevent water backing up into an area where high care
foods are being processed or exposed?
◦ Are drains regularly cleaned and inspected for clogs?
◦ Are high pressure hoses avoided when cleaning drains?
◦ Are brushes that are at least ¼” smaller than the diameter of the drain opening used to prevent splattering?
◦ Are tools for cleaning drains dedicated to that use only and color coded to prevent being used for
other purposes?
◦ If a drain backs up and water flows into an area where high care foods are being processed or exposed,
are steps taken to avoid splashing any equipment and the following sequence of steps taken to clear the
drain and clean the area around it?
• Stop any production;
• Remove any uncovered high care foods from the affected area and isolate for further review;
• Clear the drain;
• Clean and sanitize the area per the written sanitation program;
• Remove excess water from the floor.
◦ Do employees change clothes and wash and sanitize hands before touching a high care food-contact
surface after cleaning a drain?
◦ Do you use bactericidal drain treatments in high care areas?
◦ If drain rings are used, are they monitored and replaced when appropriate to maintain bactericidal properties?
◦ Are steps taken to prevent the accumulation of standing water in and around drains?
◦ Is condensate managed in a manner to prevent it from contacting exposed high care foods,
food-contact surfaces, and food packaging material?
◦ Is condensate from refrigeration evaporation coils directed to a drain through a hose or, alternatively,
collected in a pan that drains through a hose or suitable pipe to a drain?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
29

Good Manufacturing Practices and Personal Hygiene
Personal Hygiene
◦ Is health and hygienic practices training specific to control of Listeria monocytogenes in high care foods
provided for all employees, contractors and visitors who enter high care production and storage areas
(e.g., employees who conduct production, maintenance, quality assurance, quality control, or
warehousing operations), including employees and contractors who are temporary or seasonal?
◦ Is that training conducted and documented before the individual performs job activities, with refresher
training on at least an annual basis?
◦ Are personnel who supervise or are otherwise responsible for the following activities successfully trained
in the recommendations of (United States Food and Drug Administration 2017)?
• Establishing effective listericidal and listeristatic controls and ensuring that such controls consistently
operate as intended;
• Collecting and testing environmental samples;
• Determining and taking corrective actions; and
• Establishing and using written sanitation procedures and conducting associated monitoring.
◦ Are all persons who enter an area where high care foods are processed or exposed required to
thoroughly wash their hands before doing so?
◦ Do personnel who are handling exposed high care foods, FCSs, and packaging materials use suitable
utensils (such as spatulas or tongs) or wear gloves?
◦ If gloves are not used, has the need for bare hand contact to execute the job been justified and
documented against the risk of contamination?
◦ When gloves are used, do:
• Employees wash their hands before putting the gloves on;
• Multi-use gloves get washed and sanitized after the employee touches any non-food-contact surface;
• Single use gloves get discarded and replaced after the employee touches any non-food-contact
surface; and
• Gloves that are worn outside areas where high care foods are processed or exposed (e.g., restrooms)
get discarded before returning to the high care area?
Are appropriate policies in place with respect to clothing worn
in high care areas?
◦ Are gloves and footwear worn by employees who handle high care foods or who work in areas where
high care foods are processed or exposed in good repair, easily cleanable or disposable, and managed
appropriately to prevent contamination?
30

◦ Is the use of cleated footwear excluded from high care areas, unless it is necessary for
employee safety?
◦ Are gloves and footwear worn by personnel who handle high care foods or work in areas where high
care foods are processed or exposed to the environment used only in the high care area?
◦ Are practices implemented to prevent employees clothing from being a source of contamination in high
care areas?
◦ Do sanitation and maintenance personnel, management personnel, contractors, and visitors in areas
where high care foods are processed or exposed comply with the same hygiene requirements as
production employees in those areas?
◦ Are mixed hot and cold water available at hand washing stations?
◦ Have foamers, footbaths or dry powdered sanitizers been evaluated and documented for their
usefulness and effectiveness in minimizing the potential for personnel to transfer Lm from non-high
care to high care areas?
◦ Are foamers and footbaths maintained and checked at appropriate intervals to ensure their
proper function?
◦ Are personnel who handle trash, offal, floor sweepings, drains, production waste, or scrap product
restricted from handling high care food or touching high care food-contact surfaces or food
packaging material?
◦ Is handling of high care food restricted to only those authorized to do so?
Raw Materials and Other Ingredients Good Manufacturing Practices
◦ Are procedures established and implemented to manage handling conditions (time, temperature,
humidity, etc.) for Lm sensitive ingredients and other raw materials, in-process materials, and
finished foods?
◦ Are measures established to prevent cross-contamination of finished high care products by raw
materials and other ingredients?
◦ Is a written supplier approval program developed for each ingredient used in the manufacture of high
care products?
◦ Do you have procedures in place to periodically verify the efficacy of the supplier’s program?
◦ Are lethality treatments for raw materials in your operation tested to verify efficacy?
◦ Is proper documentation established and maintained for Lm control in raw materials and ingredients?
31

Listericidal Process Control
◦ Have blanch processes been validated for listericidal process control for each product?
◦ Are blanch parameters monitored with sufficient frequency to ensure that control is achieved?
◦ Are measures established and implemented on an ongoing basis to verify blanch process controls?
◦ Are corrective actions or corrections evaluated and implemented appropriately if process control
parameters have not been met?
◦ Are appropriate process control records established, reviewed, and maintained?
◦ Are continuous use brines and recycled process water used in direct contact with high care foods
discarded or decontaminated with sufficient frequency to control Listeria monocytogenes?
Other Good Manufacturing Practices
◦ Are transportation vehicles inspected for structural integrity, cleanliness, and overall suitability when
unloading ingredients and prior to loading finished products?
◦ Are transportation vehicles monitored for temperature control?
◦ Is there a written preventive maintenance program in place designed to minimize breakdowns and
prevent contamination that could occur during repair of equipment?
◦ Does the program for equipment maintenance include defined schedules for examination and
maintenance of equipment such as valves, gaskets, O-rings, pumps, screens, filters, and heat
exchanger plates?
Notes:______________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
32

Appendix I. FDA Investigations Resources
The Food and Drug Administration has several resources posted online that can be helpful to food processors
in understanding what to expect from investigators. Food Northwest recommends that processors familiarized
themselves with these resources.
FDA Investigations Operations Manual
The Investigations Operations Manual (IOM) is the primary policy guide for FDA employees who perform field
investigational activities. The manual is frequently updated, so FNW advises processors to check back on a
regular basis for updates. Additions to the manual are highlighted in gray.
http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM291746.pdf
FDA Regulatory Procedures Manual
The Regulatory Procedures Manual (RPM) is a reference manual that provides FDA personnel, such as inspectors,
investigators, and compliance officers, with information on internal procedures to be used in processing
domestic and import regulatory and enforcement matters, such as warning letters and recalls. This manual is
subject to ongoing revisions and additions, so FNW advises processors to review this document periodically for
changes effecting their business.
http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074347.pdf
FDA Compliance Policy Guides
The FDA continually issues compliance policy guides (CPG) which explain the agency’s policy on regulatory
issues related to FDA laws or regulations. They advise the FDA’s field inspection and compliance staff, as
well as the industry, as to the agency’s strategy and policies to be applied when determining industry
compliance. While alternative approaches are often allowed, FDA suggests that you discuss those approaches
with the agency.
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm
FDA Inspection Observations
The FDA makes available on their website data related to inspection and enforcement activity. Observations are
noted on Form 483s during facility inspections and can be found in the Office of Regulatory Affairs Reading
Room, as well as summarized according to the area of regulation.
https://www.fda.gov/aboutfda/centersoffices/officeofglobalregulatoryoperationsandpolicy/
ora/oraelectronicreadingroom/default.htm
http://www.fda.gov/ICECI/Inspections/ucm250720.htm
Citations are compiled into spreadsheets for use by the public and industry allowing them to make more
informed marketplace choices and to encourage compliance.
http://www.fda.gov/ICECI/Inspections/ucm346077.htm
33

At the end of an inspection, the agency classifies observations made during the inspection as to whether a
condition or practice is violative. If no objectionable conditions or practices are found, an inspection conclusion
of No Action Indicated (NAI) is assigned. If objectionable conditions or practices are found and they are
significant, a conclusion of Official Action Indicated (OAI) is assigned and regulatory action would be decided.
If the District office decides that the significant objectional conditions and practices don’t warrant regulatory
action, a conclusion of Voluntary Action Indicated (VAI) is assigned. FDA maintains a database of inspection
classifications for the public’s benefit on their website.
http://www.fda.gov/ICECI/Inspections/ucm222557.htm
Warning letters issued as a result of OAI inspections are posted and searchable on the agency’s website.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
References
American Frozen Food Institute. 2016. "Best Practices for Prevention and Control of Listeria monocytogenes in
the Post-Lethality Environment."
American Public Health Association. 2015. Compendium of Methods for the Microbiological Examination of
Foods. Fifth. Edited by Yvonne Salfinger and Mary Lou Tortorello. Washington, DC: APHA Press.
https://secure.apha.org/imis/ItemDetail?iProductCode=978-087553-2738&CATEGORY=BK
Butts, John, PhD. 2003. "Seek & Destroy: Identifying and Controlling Listeria monocytogenes Growth Niches."
Food Safety Magazine. April/May. Accessed August 31, 2016.
http://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2003/seek-destroyidentifying-and-controlling-listeria-monocytogenes-growth-niches/
Grocery Manufacturers of America. 2009. "Control of Salmonella in Low-Moisture Foods." Grocery
Manufacturers of America. February 4.
http://www.gmaonline.org/downloads/technical-guidance-and-tools/SalmonellaControlGuidance.pdf.
—. 2014. "Listeria monocytogenes Guidance on Environmental Monitoring and Corrective Actions in At-risk
Foods." University of California Food Safety. July 7. Accessed August 2016.
http://ucfoodsafety.ucdavis.edu/files/208833.pdf
Malley, Thomas J.V, John Butts, and Martin Wiedmann. 2015. "Seek and Destroy Process: Listeria
monocytogenes Process Controls in the Ready-to-Eat Meat and Poultry Industry." Journal of Food Protection
(International Association for Food Protection) 78 (2): 436-445.
http://www.ingentaconnect.com/content/iafp/jfp/2015/00000078/00000002/art00028
Pinnacle Foods Group. 2015. Food Safety and Quality Systems Audit - External Manufacturing. Pinnacle Foods
Group LLC.
Simmons, Courtenay K, and Martin Weidmann. 2017. "Identification and classification of sampling sites for
pathogen environmental monitoring programs for Listeria monocytogenes: Results from an expert eliciation."
Food Microbiology.
34

United Fresh Produce Association. 2013. "Guidance on Environmental Monitoring and Control of Listeria for the
Fresh Produce Industry." United Fresh Produce Association.
http://www2.unitedfresh.org/forms/store/ProductFormPublic/gudance-on-environmentalmonitoring-and-control-of-listeria-for-the-fresh-produce-industry.
United States Department of Agriculture Food Safety and Inspection Service. 2014. "FSIS Compliance
Guideline: Controlling Listeria monocytogenes in Post-lethality Exposed Ready-to-Eat Meat and Poultry
Products." United States Department of Agriculture. January.
http://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-e74a1e549fde/Controlling-
Lm-RTE-Guideline.pdf?MOD=AJPERES
—. 2012. "Introduction to the Microbiology of Food Processing." USDA FSIS. Accessed August 2016.
http://www.fsis.usda.gov/shared/PDF/SPN_Guidebook_Microbiology.pdf
United States Food and Drug Administration. 2017. "Control of Listeria monocytogenes in Ready-To-Eat Foods:
Guidance for Industry, Draft Guidance." January.
https://www.fda.gov/RegulatoryInformation/Guidances/ucm073110.htm
—. 2015. "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for
Human Food; Final Rule." regulations.gov. September 17.
http://www.regulations.gov/document?D=FDA-2011-N-0920-1979.
35

Questions, Comments, Corrections?
FNW would like to hear from you so we can keep this document up to date.
Please contact our staff with your feedback.
FORMERLY KNOWN AS NWFPA