Food Processing Facilities Food Safety, Quality and GMPs Audit Expectations Manual

Food Processing Facilities

Food Safety, Quality and GMPs

Audit Expectations Manual

CONTENTS

Introduction . . . . 3

Definitions . . . . 3

I . Programs Required . . . . 4

A . HACCP . . . . 4 B . Allergen Management . . . . 4 C . Training . . . . 5

D . Quality Assurance Program . . . . 5

E . Product Recovery/Traceability . . . . 5

F . Customer Complaints . . . . 6

G . Maintenance . . . . 6

H . Good Laboratory Practices

. . . . 6

II . Food Safety Practices . . . . 7

A . Food Safety Practices . . . . 7

B . Product Contamination . . . . 7

III . Grounds, Buildings, and Equipment . . . . 7

A . Plant Grounds . . . . 7

B . Plant Facilities . . . . 7

C . Equipment . . . . 7

IV . Pest Control . . . . 8

V . Good Manufacturing Practices (GMPs) . . . . 8

VI . Receiving, Storage, and Shipping . . . . 9

A . Receiving & Shipping . . . . 9

B . Storage . . . . 9

VII . Plant Sanitation . . . . 10

A . Sanitation Standard Operating Procedures (SSOPs) . . . . 10

B . Cleaning Equipment and Chemicals . . . . 10

C . Cleaning, Sanitation, and Housekeeping Procedures . . . . 10

VIII . Process Controls . . . . 10

IX . Food Defense . . . . 11

Silliker-eSTAR – Real-Time Information . . . . 12

Automatic Failure Questions . . . . 12

Resources . . . . 13

The entire content of this Manual is subject to copyright protection . Copyright © 2007 Silliker All rights reserved . The contents of this Manual may not be copied other than for use by non-for-profit organization, and appropriate reference with all copyright notices stated . The Manual may not be copied, reproduced or otherwise redistributed . Except as expressly provided above, copying, displaying, downloading, distributing, modifying, reproducing, republishing or retransmitting any information, text or documents contained in this Manual or any portion thereof in any electronic medium or in hard copy, or creating any derivative work based on such documents, is prohibited without the express written consent of Silliker Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any copyright of Silliker, or any party affiliated with Silliker

Introduction

Silliker is the leading international network of accredited

food testing and consulting laboratories specializing in

helping food and feed industry professionals ensure the

safety, quality and nutritional value of their products .

In addition to audits, our broad range of capabilities

include microbiological and chemical analysis, custom

designed research studies, such as shelf-life and

challenge studies, risk management services, including

technical consulting, short courses and training videos,

vendor certification, environmental monitoring, and

Hazard Analysis and Critical Control Point (HACCP)

programs .

Silliker Food Safety,Quality, and Good Manufacturing

Practices for Food Processing Facilities

audit expectations

were developed for food processors to use in the

assessment of their food safety and quality programs

and to prepare for a Silliker Audit .

Silliker GMP/Food Safety and Distribution Center

Audits combine a host of recognized industry practices

and principles, as well as recommendations from the

National Advisory Committee for Microbiological

Criteria in Foods, USDA, and FDA, into comprehensive

evaluation forms used by Silliker auditors . These

comprehensive audit evaluations involve a systems

review as well as a physical assessment of the facility

in the implementation of food safety and quality

systems procedures . All information obtained by Silliker

during the establishment/plant audit will be treated as

confidential between Silliker and the client . Except as

required by law, Silliker will not release any information

or report of the audit to a third party without written

authorization by the client .

Silliker recognizes that audit consistency is very

important in the food industry today .

Our auditors undergo thorough training in best

audit practices, the latest requirements from top US

companies, and calibration visits from our senior

audit staff . In addition, audit reports are reviewed by

a member of our senior audit staff . If you have any

questions or comments, please call our Audit Services

staff at +1 312 938 5151 .

Definitions

Allergen

A protein or compound that elicits an adverse reaction in a segment of the population . The nationally recognized listing of allergens includes wheat, soy, eggs, shellfish, milk, fin fish, tree nuts, and peanuts . In Canada, sulfites and sesame seeds are also considered allergens . Attribute

A microbiological, physical or chemical test, analysis, or evaluation that is used to determine the safety or quality properties of a food product . Calibration

The verifying and adjustment of equipment performance against a recognized standard to ensure accuracy of the equipment .

Certificate of Analysis A document that is provided with the receipt of a product that verifies that certain microbiological, chemical, or physical analyses were conducted on the delivered

product, and the product performed within the established criteria . Corrective Action Action that is taken when product or conditions are found to be below prescribed evaluation criteria . They should include the deviation from the criteria, the actions to be taken to bring the situation into compliance, and verification that the actions have been followed through .

Good Laboratory Practices (GLP)

Guidelines that are established to ensure the accuracy and precision of results from described evaluations . Good Manufacturing Practices

Guidelines that have been established by the Food and Drug Administration to assist food manufacturers in the production of unadulterated food products . Title 21, Code of Federal Regulations, part 110 .

Guidelines

Policies or procedures on specific tasks that may or may not be documented .

Hold

Product that has been placed in a “do not use” area and is awaiting disposition .

Instance

One issue noted for a particular question . Issues

A deviation from the prescribed standards . Numerous

Three or more instances or issues noted .

Pest control operator A certified, licensed individual or company that applies any pesticides used at a food production or distribution facility and also manages the pest control program . Primary package

The packaging material that comes in direct contact with the food product

Product Recall

An activity that recovers all shipped suspect product from the manufacturer of a product to the customers of the manufacturer, usually the final consumer of the product, the retail level .

Product Withdrawal An activity that recovers all shipped suspect product that has only reached distribution (first customer) and has not yet entered the retail market . Program

Documented policies, procedures, tasks, or activities that describe specific functions within the facility .

Quality Systems

Programs that are designed to monitor and improve the quality and safety of a food product .

Rework

Product that has been recovered or rejected from normal production, and has been reprocessed, reblended, or reformatted into the finished product .

Definitions

continued

Single/Isolated 1 or 2 instances or issues noted . Standard Operating Procedure (SOP)

A series of signed, detailed

documents that specifically define how an individual job function will be performed . Traceability

The linking of all raw materials and primary packaging to a

or distribution facility to an off-site location . The off-site location may be under the control of the food production or distribution facility .

I. Programs Required

A. HACCP

Each food manufacturer develops and maintains a Hazard Analysis Critical Control Point (HACCP) program . All records are appropriately signed/initialed including the verification approvals . Employees are aware of the HACCP-related activities in their work areas . The HACCP plan consists of the following components:

• A person trained in a formal, external HACCP course . • An established HACCP team comprised of multidisciplinary

members from within the plant with documented, routine meetings .

• A documented HACCP program detailing the seven HACCP principles that is current and available:

– Description of each product manufactured with all hazards identified on a current process flow diagram; hazard analysis documentation available

– Critical control points are identified

– Critical limits have been scientifically established and are documented

– Critical control points are monitored at regularly scheduled intervals . Monitoring procedures are documented and maintained

– Corrective action procedures are identified and applied when critical limits are not met .

– Corrective action records are maintained per records retention policy with product disposition documented . – Verification procedures have been established and

documented

– Audits of the HACCP plan are performed on a regular basis by someone independent of the plan . Records are maintained .

- All HACCP records are signed and dated . B. Allergen Management

If allergens are included in any products within the facility, then an allergen management program must be developed to address potential cross contact by allergens . Each facility is required to compile a current master list of allergens within the production environment .

The general listing of accepted allergens includes peanuts, tree nuts, milk, eggs, soybean, shellfish, fish, and wheat . In Canada, sulfites and sesame seeds are also considered allergens . If these are included in any products produced within the facility, then consideration must be made to address cross contact by allergens . Allergens are managed by two possible methods:

• Product labeling: Include all potential allergens on the label of all products produced within the facility (“This item may

contain…”)

• Allergen control: Includes the management of the

production schedule to list products with allergens produced prior to sanitation activities . It also includes the proper cleaning and sanitizing of equipment contacting allergens . A verification program is needed to insure compliance with allergen control procedures . Facilities having allergens must have a documented allergen rework program . Products that contain rework must also be considered when potential allergenic ingredients are used . Appropriate allergen controls must be applied to the rework as well . Additional controls that should be included in the allergen management program are:

• Storage of allergens in dry storage, all allergens need to be segregated from non-allergens and non-like allergens • Ingredient storage, all allergens need to have a dedicated

storage bin, and dedicated dispensing utensil and weigh vessel, if applicable .

• Documented change over procedures for switching from allergens to non-allergens .

This should include a Sanitation Standard Operating Procedure, monitoring to ensure product removal, and verification of the SSOP . Appropriate testing methods should be used to ensure effective allergen removal .

• A label reconciliation program is established to ensure that all product labels accurately reflect the presence of allergens based on product formulations, and random audits of products with allergens to ensure that the labels are accurate .

• Facilities under FDA regulation must comply with the US FDA Food Allergen Labeling and Protection Act of 2004 .

C. Training

Training must be conducted for all employees of the production facility . This must include orientation for new employees, as well as regular training for established employees . This on-going training must occur at least annually . The types of training that are required include:

• Food safety training – An awareness of how foodborne illness occurs, and the role of food plant employees in the A. HACCP

B. Allergen Management C. Training

D. Quality Assurance Program E. Product Recovery/Traceability F. Customer Complaints

G. Maintenance

H. Good Laboratory Practices finished product through a coding or tracking system . Transport vehicle Any vehicle that is used to carry food products from one area of the food production

transmission of microorganisms that can cause outbreaks and/or recalls . All employees should have GMP training on the specific GMP program for the facility . This should be presented and available in languages other than English when appropriate .

• HACCP training – Those employees that are involved in the development, management, implementation, or completion of the HACCP plan or HACCP activities must be trained . This should include all production employees that have CCPs that are monitored, or exist in their work area .

• Sanitation – Any employees that are involved in sanitation tasks and who have emergency sanitation responsibility must have training that is specific to their job functions . This should include specific SOPs for cleaning equipment as well as proper chemical handling, mixing, and storage . If an outside company is hired to perform sanitation tasks, then their training program must be available .

• Food Defense – All employees throughout the company should be trained on the basics of protecting food from intentional contamination . They should also be trained on what the company policies are for protecting their people, facilities, materials and products . These policies should include managing access for employees, contractors and visitors; managing materials and products coming in, being stored, and shipping out; and what to do when employees see something suspicious .

When appropriate, evaluation criteria for knowledge obtained should be used . Documentation of all training must be kept . This should include the agenda for the training, the date that the training took place, who conducted the training, and who attended .

D. Quality Assurance Program

All food production facilities need to have a quality assurance program that ensures the quality and consistency of the products that they produce . This program should include an organizational chart, all procedures that QA/QC personnel perform, and the appropriate documentation that is necessary to be completed . All QA/QC programs should be organized for ease of use . Quality program records shall be approved with signatures and dates . Some specific programs that need to be included in the QA program include (but are not limited to):

• Written specifications for raw and finished products, as well as packaging materials .

The ingredients, finished products, and packaging materials must undergo some type of scrutiny upon entry into the facility or prior to exiting the facility . Documentation must be kept to demonstrate that these checks are indeed occurring . Evaluation criteria must also be included in the procedures to allow for determination when an item is “out of compliance” . Corrective actions must be documented for all instances when the criteria have not been met . Receiving certificates of analysis for incoming products should be part of the incoming material assessment .

• Procedures and criteria exist for a “hold and release program” . This program is designed for product that has not met specifications or is awaiting results of the checks for conformance to specifications . A “hold and release program” should include the following attributes:

– A designated area that is for “on-hold” product only . This area is clearly marked and it is well known that products

in the area are not to be used . A computer system that would prevent shipment of product or use of ingredients would be sufficient .

– A system for identification of product that is on hold . This can include tags, color-coding, or signs . Any system of identification should include the identification of the product (code date, lot number, etc .), date of the hold, and declaration that item is not to be used or distributed . – A log book or record (can be electronic) of all holds

within the facility . This should include the hold number, the product identification, the reason for the hold, the date of the hold, and the product disposition . This log book should be reconciled frequently to ensure all held product is accounted for .

• Facility must have a documented record retention policy for all QA/QC records . The policy must describe the documents that are covered by the policy, the length of storage and storage area for retained records . The policy must include the use of electronic records and back-up systems for electronic records .

• Facility must have an established glass and brittle plastic policy . The glass policy must describe the shielding of glass used in the facility . The policy should specifically state what glass must be shielded, what action is taken if a glass breakage is detected, and how glass packaging is addressed and controlled in production areas (if applicable) . There should also be a brittle plastics policy explaining how the facility handles any brittle plastics within the facility . Documentation must be kept of all QA/QC functions . Any occurrence of product failing to meet specific QA/QC criteria must include product disposition . This disposition should be made by an appropriately trained and qualified individual .

• Facility should have a documented label verification program to ensure accuracy and regulatory compliance .

E. Product Recovery/Traceability

All products must be able to be traced within the facility . Incoming raw materials and primary packaging must be able to be linked with the finished product . All incoming ingredients and primary packaging must be identified in such a manner that they can be included on production records, or linked by another defined means to the finished product in which they were used in the production . The traceability (coding) should be well understood . A formal product recovery program is required to be in place in order to recover shipped product in the event of a recall or product withdrawal . The following elements need to be included in a product withdrawal program:

• A current 24 hour/ 7 day a week availability list of key personnel and customers .

• Procedures on how to conduct a product recall . This should include how to identify product, how to determine the amount of product produced, the amount of product shipped, where it was shipped, and the amount of product still within the facility (if applicable) . Procedures should also include the reconciliation of documented product found versus actual product produced and shipped .

• Worksheets to aid in the completion of the recall A mock recall needs to be conducted at least annually . This mock recall should include all appropriate documentation (production records, shipping documents, and recall

worksheets) . A guideline to follow is that all products (100%) should be identified within 2 hours . An actual recall should not take the place of a mock recall . Any portion of a mock recall that is found to be deficient should be tested again . Food production facilities must have the ability to recall ingredients as well as primary packaging materials . F. Customer Complaints

A program needs to be in place to track and record all customer complaints . Those valid complaints that are related to food safety or food quality issues need to be summarized and analyzed over a period of time to identify probable cause trends or producer issues . When trends or significant issues are discovered, documented corrective action should take place to improve producer performance .

G. Maintenance

A maintenance program that is food safety based needs to be developed and implemented . Included in the maintenance program should be a preventive maintenance section . Elements of a preventive maintenance program should include:

• A schedule for when specific preventive maintenance activities will occur

• Calibration of key equipment (thermometers, scales, etc .) on a regularly scheduled basis . The maintenance program should include a work order type system so that employees can identify equipment that needs repair . The work orders should be prioritized by food safety significance, with the items most critical to food safety designated with the highest priority . Documentation needs to exist that details the type of repair, the materials used, and that sanitation was notified that equipment needed proper sanitation prior to placement back into production .

• Temporary repairs with inappropriate materials (tape, cardboard, wood, plastic, etc) should not exist within a food production facility .

• Guidelines to ensure product protection during maintenance activities, specific to include when product is exposed vs . not exposed . Tools should be properly cleaned and sanitized when used with food contact surfaces or in production areas . There should be a written policy delegating with documented verification on who ensures the food contact surfaces are cleaned and sanitized after maintenance work is performed .

• Guidelines are established to ensure tool and part control when repairs are taking place . These should include proper placement of nuts and bolts, tools used in raw areas vs . finished product areas, etc .

Maintenance equipment and materials must be adequately stored when around processing equipment to prevent potential contamination . Only food grade lubricants with properly labeled grease guns are used in the processing facility for food contact equipment, and they should be properly stored .

H. Good Laboratory Practices

A documented GLP program needs to be in place . It must include standard operating procedures (SOPs) for the performance of each specified method . Methods should be documented and appropriately referenced . An internal quality control program must exist to ensure the results of the analyses are accurate . Routine participation in a proficiency program is utilized for verification of results . Laboratory employees must be trained for the tasks that they are performing . All laboratory equipment must be on a regular calibration schedule . With results documented and verification procedures of calibration . • If the lab is testing for pathogens, the laboratory must be physically isolated from production areas . Controls to prevent pathogen contamination need to be in place .

• There must be a program for running positive controls/cultures with documented records for all analyses .

II. Food Safety Practices

A. Food Safety Practices

Employee and equipment traffic flows are used to minimize contamination from raw and finished products . All employees need to follow in-place activities to separate raw materials from finished product areas . The activities may include footbaths, hand washing, changing of frocks, etc . Processing areas are designed to minimize cross-contamination (separation of raw materials, finished products, storage areas, and distribution areas) . Employees will comply with the Good Manufacturing Practices including:

• Employees with an obvious medical condition shall not be allowed to have direct contact with exposed food products or production/storage areas

• Employees wash their hands after any activity that may contaminate them

• Employees wash hands prior to entering production areas, handling product, entering packaging areas, touching product contact surfaces, or other areas where contamination may occur

B. Product Contamination

No contamination of raw or finished product is observed . This contamination could occur in the form of condensation, product contact with water from a non-potable source, insects, rodents, glass, wood, plastic, etc . No overhead condensation should be present in the processing area . The use of high pressure water hoses or high pressure air in production areas with product present or where food is stored is strictly prohibited .

• No condition or practice exists that may potentially contaminate product, or could lead to product contamination .

• No equipment used has the potential to contribute to the contamination/adulteration of product with physical, chemical or microbial contaminants .

III. Grounds, Buildings, and Equipment

A. Plant Grounds

Within 20 feet of the building, all weeds, litter, parking lots, and grounds are well maintained with no harborage areas for pests . All equipment that is stored within this 20-foot area must be at least 6 inches off the ground . Any tube or piping must have the end caps sealed to prevent harborage sites . No standing water is found on the facility grounds but especially within 20 feet of the buildings .

The dumpster area is clean, with no litter overflowing onto the ground . The lids on the dumpsters are closed . All loading dock and shipping areas are well maintained . All dock levers, dock shelters, and bumpers are clean and in good repair .

B. Plant Facilities

The food plant facility is structurally sound with no roof leaks . Floors, walls, and ceilings are well maintained and properly designed . All product zone surfaces should be made of easily cleanable, non-porous material . This includes walls in dry storage areas . All outer openings are protected to prevent pest entry . No opening exists that is greater than 1/4 inch . The interior of the facility should have an 18-inch perimeter for sanitation and pest control . This includes all break rooms, locker rooms, coolers, dry storage areas that are located along the interior perimeter of the facility .

All lights in production, storage, shipping, and receiving must be shielded or protected against breakage . All areas of the facility should have proper lighting .

Annual testing of the water must be done to ensure potability . The samples must be taken at the processing facility and analyzed by a certified laboratory . All water lines are protected against back flow or cross-connections . All hoses in the facility, including janitor sinks, are protected against back flow . All drain lines into floor drains are protected by an air gap or an appropriate back flow preventor .

Ladders and walkways over exposed product lines are protected with kick plates or other appropriate means . The kick plates should be at least 4 inches in height .

C. Equipment

All plant equipment must be designed for proper sanitation . All material must be easily cleanable, non-porous, and easily accessible . Equipment should be used only for the task for which it was intended .

Adequate ventilation equipment is utilized to prevent odors and vapors . Fans and other air blowing equipment are cleaned and well maintained .

Vehicles and equipment used for moving raw materials, finished products and packaging throughout the facility are cleaned and well maintained .

IV. Pest Control

Each food processing facility must have a documented pest control program . It must include a designated pest control operator, scheduled frequency of service, as well as the following documentation:

• A current, dated map of the facility, which shows all pest control devices both inside and outside the facility . These include glueboards, insect light traps, tin cats, mechanical traps, pheromone traps, etc . The devices should be numbered so that activity and service can be tracked . • Service records showing any chemicals used, the method

of application, any signs of pest activity, corrective action due to activity noted, description of service rendered, and signature of pest control operator .

• If a third party is performing service, then current business license and insurance must be available at time of review . • A current certification for all persons who are applying

chemicals for pest control activities at the facility .

• Any pesticide used at the facility must be EPA approved for use in an industrial food processing facility . A sample label and MSDS sheet must also be available .

• Service labels must be kept on the interior of all pest control devices . These labels must contain the date of service and the initials of the PCO who performed the service . Punch cards may be used if the PCO who punches the card signs it . Any pesticides stored at the facility must be in a segregated, secured facility . To be secured, the stored area must be locked . On the interior of the facility, there must be pest control

devices around the interior perimeter of the facility, spaced approximately 25 feet apart . This includes any locker room, break room, dry storage area, cooler, or processing area that shares an outside wall . All dry storage areas need pest control devices placed appropriately . On each side of each exterior door, there must be a mechanical trap within 10 feet of the door . All devices must be located so as not to contaminate product, packaging material, or equipment . No bait is to be used on the inside of the facility . All devices should be functioning properly and in good condition .

Insect light traps, if used, must be properly located so as not to contaminate product . If stun (low voltage) type of insect light traps are utilized, they must not be stored directly above exposed product . If the explosive (high voltage) types are used, then insect light traps must not be stored within 30 feet of exposed product or within 10 feet of packaged product . This includes all shipping and receiving areas .

All interior devices should be checked by a PCO at least twice per month . There should be no decomposed rodents found in the devices . There should be no signs of pest activity inside the facility, especially around food products or packaging materials . On the exterior of the facility, there needs to be tamper-resistant bait stations positioned approximately every 50 feet around the exterior perimeter of the facility . In public areas or areas not

A. Food Safety Practices B. Product Contamination

A. Plant Grounds B. Plant Facilities C. Equipment

allowed to contain pesticides by local ordinance, no pest control stations are required . However, bait stations must be utilized in all other areas except those prohibited by local regulation . The stations must be secured in place at the ground-building junction . Attaching to a patio block, chaining to the building, or anchoring to the ground are all acceptable means of securing the station . Tamper- resistant means that a tool must be used

to open the bait station . Bait inside the station must have a fresh appearance and be secured . All exterior stations must be checked at least once per month .

There should be no pest activity on the exterior of the building . Activity includes bird nests, heavy insect activity in close proximity to the building, burrowing, excessive pellets in stations, and heavily chewed or missing bait .

A documented GMP program has been established . The program includes a section on employee hygiene practices, as well as procedures for outer garment and uniform control . An appropriate program for uniforms and outer garments includes that employees should not wear outer garments out of the facility . Uniforms can be laundered by employees, provided a properly laundered outer garment is worn while at their work stations . Outer garments should be laundered by company at a proper location or by a third party service . No outer garments should have pockets above the waist or have buttons .

The section on employee hygiene practices includes directions on use of hair restraints in production and storage areas by all employees, no jewelry other than plain wedding bands, personal cleanliness and hand washing, no artificial finger nails or exposed body piercings allowed in the processing area . Any employee with a beard must wear a beard cover in processing and storage areas . Also included must be no eating, drinking, smoking, gum chewing in any production, storage, receiving,

or shipping area . Gloves, if worn, must be clean and in good condition . Hand washing must occur before putting gloves on, as well as before any application of a hand sanitizer, after all breaks, and prior to handling product or packaging materials . Appropriate signage stating the basic GMPs must be posted at all restrooms, break rooms, and entrances to processing and storage areas . If applicable, signs in other languages may need to be posted as well . All locker rooms must be clean, with no food stored in lockers . All restrooms must be clean, have fixtures in good repair, have adequate ventilation and have hot and cold running water, hand soap, and an appropriate hand-drying device . Water and towel operations must be hands-free . Break rooms should be kept clean and free of aged debris .

A monthly self-audit that covers all areas of the facility and all processing operations should be conducted by a team of appropriately trained personnel . Findings from the audit must be reviewed with plant management, and corrective actions for deviations need to be developed and implemented .

VI. Receiving, Storage, and Shipping

A. Receiving & Shipping

B. Storage

V. Good Manufacturing Practices (GMPs)

A. Receiving & Shipping

A program needs to be in place to ensure that all incoming ingredients and packaging materials are from approved suppliers . A master list of approved suppliers, the products that they supply, and contacts should be available . A method of monitoring the supplier performance needs to be in place . This can include internal QA checks, third party audits, periodic verification of certificate of analysis (COA) results, as well as additional methods for monitoring . A feedback mechanism needs to be in place when supplier performance is observed to be below standard .

Each food processing facility must have an inbound inspection program for all raw materials, ingredients, and packaging materials . This inspection should include trailer condition, temperature of product (if applicable), condition of product, any evidence of infestation, and conformance to specifications . Letters of guarantee are required when appropriate, as well as certificates of analysis (COA) . All incoming ingredients and materials should be dated with the date of receipt . A first in/first out (FIFO) or first expired/first out (FEFO) rotation system is in place for all food products, ingredients, and packaging materials . Documentation for all observations must be completed .

Equipment used to receive bulk ingredients must be clean, hoses must be capped when not in use, and all must be stored off the ground .

Products must not be stored in the receiving or shipping area . Staging is allowed for the purpose of paperwork completion

on inbound product or loading of outbound product . Products should promptly be moved into permanent storage areas . All products must maintain proper temperature during receiving, staging, and shipping .

Receiving and shipping areas need to be clean, organized, and free of debris and spilled product . Receiving and shipping areas for perishable products should be temperature controlled . All outbound transport vehicles should be inspected prior to loading product . The vehicles should be clean, free of infestation, capable of maintaining proper temperature, and pre-cooled, if applicable .

If a facility uses outside storages, these facilities shall be in a documented program that includes self or third-party inspections . Through documentation, the outside facilities shall demonstrate they can meet the same requirements as the facility being audited .

B. Storage

All storage facilities must have an 18 inch access around the interior perimeter of the storage area for sanitation and pest control activities . All products and materials must be stored at least 6 inches or pallet height above the floor . All storage areas are clean and well maintained . All floors, walls, and ceilings are in good repair and made of appropriate materials (non-porous and easily cleanable) . All spills are cleaned promptly . There is no aged ice in freezers .

Containers that are single use are not reused unless they can be adequately sanitized . Ingredient containers or finished product containers or packaging are used for the intended purpose only . Soiled or broken pallets are not used . Empty pallets are not stored near raw material, food processing, or food storage areas . All cases and packages are in good condition . Any damaged product, ingredient, or material is immediately segregated and repacked or discarded . Any restricted chemical for use in processing or as an ingredient is stored in a segregated, secured location .

Temperatures of coolers and freezers are adequate to ensure product temperature requirements . Monitoring of temperatures is done twice per day, or on a continuous system with alarm . Documentation of temperature checks is kept .

Coolers and freezers show no sign of condensation . Products stored in freezers and coolers should be free from condensation and ice .

VII. Plant Sanitation

A. Sanitation Standard Operating Procedures (SSOPs) Each processing facility must have a master cleaning schedule that details tasks to be done by the sanitation personnel on a periodic, regular basis . The sanitation schedule should include all areas of the facility, including outside . Standard operating procedures for completing sanitation activities, including pre-operational inspection, must be developed and implemented . The SSOPs must include the task to be completed, the responsible party, the chemicals and equipment necessary, the method used, the frequency, and records that must be completed once the task is complete . A visual pre-operational inspection must be done on a regular basis to verify sanitation . Additional environmental monitoring tools of rapid monitoring (bioluminescence) and microbiological swabbing should be utilized as needed . When monitoring activities show that sanitation is deficient, then corrective action must be developed and documented . Appropriate documentation for all tasks completed must be kept .

B. Cleaning Equipment and Chemicals

All chemicals used for cleaning and sanitizing must have EPA approval for use in an industrial food processing facility . MSDS must be kept of all products used and be easily accessible .

Any chemical not in its original container must contain an appropriate, permanent label . All chemicals must be stored in a secured, segregated location when not in use . Test kits or sanitizer strength strips are routinely used to monitor chemical concentration for hand dip stations, foot baths, and sanitizing solutions . Procedures for checks are established and records documented .

Equipment, containers or brushes used for cleaning and sanitizing are color coded or labeled to appropriately identify them for their intended use . Cleaning equipment must be made of nonporous material, clean and properly stored when not in use . This storage is not in food processing areas .

C. Cleaning, Sanitation, and Housekeeping Procedures Cleanliness must be maintained in all areas of the plant . There should be no evidence of aged spills in processing or non-processing areas . Excessive moisture and condensation are removed promptly; floors are free of standing water .

All equipment used in wet processing is cleaned and sanitized on a regular basis .

A. Sanitation Standard Operating Procedures (SSOPs) B. Cleaning Equipment and Chemicals

C. Cleaning, Sanitation, & Housekeeping Procedures

VIII. Process Controls

Appropriate process control points within the production of the product shall be established by each production facility . Limits or ranges must be defined and monitored on a regularly scheduled basis . Corrective action is taken when monitoring reveals products not within established criteria . Documentation is completed for all tasks .

All processing operations are conducted to protect the product from contamination . Product maintains established temperature parameters throughout production . Thawing or tempering of frozen product is done under controlled conditions and is monitored to ensure that proper temperature control is maintained . Heated ingredients and finished products are rapidly cooled or used in a subsequent processing step without delay . Any breakdowns or shutdowns are monitored to insure that product integrity is not compromised or product is not temperature abused . All perishable products must be promptly removed to storage when shutdowns, breakdowns, or extended breaks occur .

All packaging materials are kept clean, dry, and stored appropriately . When glass is used as a packaging material, a glass control program is in place . Otherwise, no glass should be in the production area .

Ingredient containers are properly labeled and/or color coded and covered as appropriate . If a color coding system is utilized, then appropriate signage must be posted in areas of heaviest use, or areas with high volumes of employee traffic .

Proper equipment is installed to ensure protection of the product from foreign material .

This can include metal detectors, X-ray, screens, magnets, sieves, etc . These devices are well maintained and are on the preventive maintenance schedule for routine checking . Where metal detectors are mandatory by customers, calibration of the detector needs to be completed using the prescribed sensitivity . The method for checking the metal detector needs to be developed by the customer or the processing facility . The metal detector should be positioned as close to the final packaging step as possible, or preferably after product is already in the package . Foreign material control systems must have automatic rejection or line stoppage mechanisms when metal or other foreign material is detected . Documentation of calibration checks of the metal detector must be maintained .

IX. Food Defense

All food processing facilities need to take measures to address food defense risks within the facility . At a minimum, the following areas should be addressed:

• Have a documented food defense plan that outlines the following items:

- A multidisciplinary team designated to meet annually and review the plan for completeness and accuracy as well as to either perform (or ensure one is performed) a vulnerability assessment of the facility and all of its processing operations .

- Employee/contractors/visitors management: How

employees/contractors/visitors are screened, hired, trained and provided limited access only to areas where access is required . This would include: reference checks, drug testing, and background checks where appropriate . - A description of how processing areas are protected

throughout processing . This includes control of:

o Raw materials, ingredients (including bulk), packaging materials, food processing equipment, etc . This should also include verification inspection upon receipt and shipping of all materials . This also includes how the water sources are to be protected as well .

o Policy for sealing and/or locking (less than full loads) of trailers (both incoming and outgoing shipments) . o Driver (delivery or shipping company) verification

procedures (to minimize the potential for products being shipped by unauthorized drivers/companies) . o Access to potential harmful substances (chemicals,

pesticides, reagents, etc) .

o Access to formulation software, recipes, specifications, etc .

- If under FDA regulatory guidance: the plan must include how the facility will meet the basic requirements of the Bioterrorism Act of 2002:

o Registration: a letter signed by the plant manager stating that the facility is registered with the FDA as required by the Act will suffice .

o An explanation of how the facility determines who their suppliers and customers are . The FDA requires facilities to be able to easily identify suppliers and customers (one up and one down the food chain) . o If a direct importer of any foods or ingredients: the

plan should indicate how the facility will meet the obligations of prior notice as required by the Act . o An explanation of how the facility will meet the

records maintenance requirements of the Act . • These items should be verified each year by the team and

will be evaluated through internal and external audits as well through policy review, direct observations and records verification .

Automatic Failure Questions

Question I A #8

Corrective action procedures have been identified and are taken when critical limits are not met . Corrective action records are maintained . Product disposition is documented .

Question I B #2

Employees with obvious sores, infected wounds, or other infectious illnesses shall not be allowed to have direct contact with exposed food products or production/storage areas .

Question I C #1

No actual product contamination is observed .

Question I D #1

Allergens

The facility processes allergens and has no allergen control program developed .

Question I F #1

Bioterrorism

Registration

The FDA regulated facility is not registered with the FDA . Only applies to FDA regulated facilities .

Question II B #1

A documented GMP program has been established . It complies with all applicable regulations .

Question II C #1

A written pest control program has been established . It must include a designated pest control operator (internal or an outside service); scheduled frequency of service; types of pesticides used and location of application, and a current map showing the location and type of all devices (internal and external) . All records and documents must be readily accessible .

Question II D #5

The facility water is from a potable source . Potability is checked at least annually with a sample taken at the plant location, and proper records are maintained .

Question II E #6

All finished products shall be properly coded for traceability . Lot or batch number records of ingredients can be linked to the finished product, including traceability for reworked product .

Question IV #7

There is no evidence of decomposed pests (NOT insects or flies) anywhere in the interior of the facility .

Question IV #8

There is no evidence of insects, spiders rodents or birds on or in any food ingredients, products or packaging material .

Additional information can be obtained by referring to the sites listed below.

HACCP

http://www .haccpalliance .org/

http://www .cfsan .fda .gov/~lrd/haccp .html

CANADA: http://www .inspection .gc .ca/english/ppc/psps/haccp/haccpe .shtml

Recall Procedures

FDA/ ORA Regulatory Procedures Manual Chapter 7 Recall & Emergency Procedures http://www .fda .gov/ora/compliance_ref/rpm_new2/ch7 .html

Food Allergens

Compliance Policy Guide Sec . 555 .250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens http://www .fda .gov/ora/compliance_ref/cpg/cpgfod/cpg555-250 .htm

CANADA: http://www .inspection .gc .ca/english/bureau/inform/allergen .pdf

Food Security

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL107-188) http://www .cfsan .fda .gov/~dms/sec-ltr .html

Food Producers, Processors, Transporters, and Retailers: Food Security Preventive Measures Guidance http://www .cfsan .fda .gov/~dms/secguid .html

Good Manufacturing Practices

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food 21 CFR Part 110 http://www .cfsan .fda .gov/~lrd/part110t .html

Good Laboratory Practices

FDA Laboratory Procedures Manual http://www .fda .gov/ora/science_ref/lpm/lpmtc_dec02 .html Proficiency testing information: http://www .aoac .org/proficiencytesting/proficiency .html

Sanitation

http://www .fsis .usda .gov/OPPDE/rdad/frpubs/sanitationguide .htm

Pest Control

http://www .nrcs .usda .gov/technical/ECS/pest/pest_policy .doc

National Pest Management Association, http://www .npmapestworld .org/

General

21 CFR 110 http://www .access .gpo .gov/nara/cfr/waisidx_02/21cfr110_02 .html

Quality Systems

Food Processing Industry Quality System Guidelines, ASQ Food, Drug, and Cosmetic Division; www .asq .org

Resources:

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111 E . Wacker Drive, Ste . 2300 Chicago, IL 60601 / USA Tel . +1 312 938 5151 email . info@silliker .com www .silliker .com