Survey of Current Manufacturing Practices in the Food Industry

Survey of Current Manufacturing Practices in the Food Industry

Food Industry Survey Apr-10-07

Survey of Current Manufacturing Practices in the Food Industry

OMB: 0910-0628

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April 10, 2007 ERG

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Password: ___________________________


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INTRODUCTION

The U.S. Food and Drug Administration (FDA) needs your help to gain a better understanding of current manufacturing practices. FDA will use the information from this survey as it considers how to modernize the Food GMPs (21 CFR 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food). Thus, your participation is vitally important.


You have been selected to receive this survey because you registered your facility with the FDA and provided an email address that permits contact electronically.


This survey collects information on the following five (5) key areas in addition to some facility-specific information to characterize your responses:


  • Training

  • Sanitation and personal hygiene

  • Allergen controls

  • Process controls

  • Recordkeeping


This survey will take around ?? minutes to complete. You will have the ability to leave the survey at any time and come back to finish it at a later time.


Your participation in this survey is voluntary, and we greatly appreciate your help. Your responses will be compiled by Eastern Research Group, Inc. (ERG), an FDA contractor, and will be kept CONFIDENTIAL. ERG will only provide aggregated data to FDA, without any facility or respondent identifiers. You can view more detail on how we are ensuring the confidentiality of your responses by clicking on “Privacy and Security Statement.”


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INSTRUCTIONS


  1. If you are not the appropriate person to complete this survey, we ask that you forward the survey invitation we emailed you to the appropriate person in your organization.


  1. Please answer each question as it pertains to your facility.


  1. If you do not know the answer to a particular question, please consult with other members of your organization.


  1. Throughout the survey, we use various words and phrases to have particular meanings. These are underlined. Please click on these to see a definition.


  1. You need to provide a response to those questions marked with an asterisk (*) to be able proceed to the next applicable question.


  1. If you would like to leave the survey at any time, just click on “Log out” at the top of the page. Your answers will be saved and you will be able to come back to finish the survey at a later time by logging in with your existing password.


  1. If you have any questions throughout the survey, please refer to the frequently asked questions (FAQs) by clicking on “FAQs” at the top of the page. You can also contact the survey helpline at surveyhelp@erg.com.


Thank you very much for your participation! Please click on the “Next Page” button to start.


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FACILITY PROFILE


Q1.(*) For verification purposes (i.e., if you misplace your password and need to request it), please provide your email address below.


Email address__________________


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Our records indicate that the name and location of your facility are as follows:


Facility Name _____________________

Street _____________________

City _____________________

State _____________________

Zip code _____________________


Q2. Please update and/or correct the information below as appropriate. This information will be used to confirm that you should be a respondent to this questionnaire because you manufacture or process food. The information you provide on this and the following questions will be kept strictly confidential. If the information does not need to be updated or corrected, please go to the next page of questions.


Facility Name _____________________

Street _____________________

City _____________________

State _____________________

Zip code _____________________


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Q3.(*) What is your primary operation at this facility? Please check only one.

_____ Manufacturer/processor of food for human consumption [Go to Q4]

_____ Manufacturer/processor of food additives/food ingredients [Go to Q5]

_____ Manufacturer/processor of food for animal consumption [Go to END1]

_____ Manufacturer/processor of dietary supplements [Go to END1]

_____ Distributor [Go to END1]

_____ Repacker/packer

_____ Warehouse/holding facility [Go to END1]

_____ Labeler/relabeler [Go to END1]

_____ Salvage operator (reconditioner) [Go to END1]

_____ Contract sterilizer [Go to END1]

_____ Interstate conveyance caterer/catering point [Go to END1]

_____ Commissary [Go to END1]

_____ Other ______________________________ [verbatim] [Go to END1]


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Q6.(*) Please choose from the list below the primary industry that corresponds to the types of products you process or pack at this facility. Please select only one.

_____ Drop-down 1


[Programmer Note 1:

  • If Q7 = “Animal Slaughtering & Processing” or “Beverage Manufacturing-Breweries” or “Beverage Manufacturing-Wineries” or “Beverage Manufacturing-Distilleries”, go to END1

  • If Q8 = “Postharvest Crop Activities,” go to Q9


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Q10.(*) Please choose from the list below the secondary industry or industries, if any, that corresponds to any additional types of food products you process or pack at this facility. Please select all that apply.

_____ Drop-down 2


[Programmer Note 2:

  • If Q11 =“Seafood Product Preparation & Packaging-Seafood Canning” or “Seafood Product Preparation & Packaging-Fresh & Frozen Seafood Processing, go to Q12

  • If Q13 =“Dairy Product Manufacturing-Fluid Milk Manufacturing” or “Dairy Product Manufacturing-Creamery Butter Manufacturing” or “Dairy Product Manufacturing-Cheese Manufacturing” or “Dairy Product Manufacturing-Dry, Condensed, & Evaporated Dairy Product Manufacturing” or “Dairy Product Manufacturing-Ice Cream & Frozen Desert Manufacturing”, go to Q14

  • All others, go to Q15]


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Q16.(*) Please choose from the list below the one industry description that corresponds to your primary food-related business at this facility. Please select only one.

_____Basic Chemical Manufacturing-Alkalies & Chlorine Manufacturing (e.g., sodium bicarbonate) [Go to Q17]

_____Basic Chemical Manufacturing-All Other Basic Inorganic Chemical Manufacturing (e.g., zinc oxide) [Go to Q18]

_____Basic Chemical Manufacturing-All Other Basic Organic Chemical Manufacturing (e.g., citric acid, lactic acid, tartrates, saccharin,

alginates) [Go to Q19]

_____Other Food Manufacturing-Spice & Extract Manufacturing (e.g., natural food colors, pectin) [Go to Q20]

_____Other Food Manufacturing-All Other Miscellaneous Food Manufacturing (e.g., yeast) [Go to Q21]

_____Pesticide, Fertilizer, & Other Agricultural Chemical Manufacturing-Phosphatic Fertilizer Manufacturing (e.g., phosphoric acid) [Go

to Q22]

_____Pharmaceutical & Medicine Manufacturing-Medicinal & Botanical Manufacturing (e.g., vitamins, ascorbic acid) [Go to Q23]

_____Pharmaceutical & Medicine Manufacturing-Pharmaceutical Preparation Manufacturing (e.g., vitamins, zinc oxide) [Go to Q24]

_____Resin, Synthetic Rubber, & Artificial Synthetic Fibers & Filaments Manufacturing-Plastics Material & Resin Manufacturing (e.g.,

methyl cellulose) [Go to Q25]

_____Starch & Vegetable Fats & Oils Manufacturing-Soybean Processing (e.g., lecithin) [Go to Q26]

_____Starch & Vegetable Fats & Oils Manufacturing-Other Oilseed Processing (e.g., coconut oil) [Go to Q27]

_____Starch & Vegetable Fats & Oils Manufacturing-Fats & Oils Refining & Blending (e.g., linseed oil) [Go to Q28]


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Q29.(*) Does your post harvest operation involve packing of fresh produce?

_____ Yes

_____ No [Go to END1]


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Q30. Which of the following describes your structure, if any, where you pack fresh produce? Please check all that apply.

_____ Field with no special equipment or physical structure

_____ Field with specialized equipment, such as a mule train or rolling conveyor, but no physical structure

_____ Floor (e.g., concrete slab) and roof

_____ Floor, roof, and some walls or screening but not completely enclosed

_____ Enclosed structure with openings, such as unscreened doors and windows

_____ Completely enclosed structure

_____ Other __________________________________ [verbatim]


Q31.(*) Which of the following describes your use of water when you pack fresh produce? Please check only one.

_____ Field with minimal processing and no water contact (e.g., minimal trimming and sorting) [Go to Q32]

_____ Field with some processing and water contact (e.g., significant trimming, coring, washing, and cooling) [Go to Q33]

_____ Physical structure with minimal processing and no water contact (e.g., minimal trimming and sorting)

_____ Physical structure with some processing and water contact (e.g., trimming, coring, washing, waxing, and cooling)


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Q34. Please indicate the type of cooling method that you use at your packing facility? Please check only one.

_____ Cold room (room cooling) [Go to Q35]

_____ Forced-air (pressure) cooling [Go to Q36]

_____ Hydrocooling [Go to Q37]

_____ Contact icing (top icing or package icing) [Go to Q38]

_____ Vacuum cooling [Go to Q39]

_____ Cooling is done off site [Go to Q40]


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Q41. Do you process any of the following refrigerated ready-to-eat products? Please check all that apply.

_____ Smoked seafood [Go to Q42]

_____ Raw seafood [Go to Q43]

_____ Preserved fish [Go to Q44]

_____ Cooked ready-to-eat crustaceans [Go to Q45]

_____ None of the above [Go to Q46]


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Q47. Do you process any of the following refrigerated ready-to-eat products? Please check all that apply.

_____ Fresh soft cheeses

_____ Soft unripened cheeses

_____ Soft ripened cheeses

_____ Semi-soft cheeses

_____ Hard cheeses

_____ Processed cheeses

_____ Pasteurized fluid milk

_____ Unpasteurized fluid milk

_____ Ice cream

_____ Frozen dairy products other than ice cream

_____ Cultured milk products other than yogurt

_____ Yogurt

_____ None of the above


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Q48.(*) Does this facility operate year round or on a seasonal basis?

_____ Year round

_____ Seasonal [Go to Q49]


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Q50. How many employees in total typically work at your facility?

_____ 20 or fewer

_____ Between 21 and 100

_____ Between 101 and 500

_____ Between 501 and 750

_____ Between 751 and 1,000

_____ 1,001 or more


Q51. What percent of your total employees are part-time or temporary?

_____ 0%

_____ 5% or less

_____ >5% to 10%

_____ >10% to 25%

_____ >25% to 50%

_____ >50% to 75%

_____ >75%


Q52. Approximately, how many production line managers/supervisors do you employ?

_____ 5 or fewer [Go to Q53]

_____ 6 to 10 [Go to Q54]

_____ 11 to 30 [Go to Q55]

_____ 31 to 50 [Go to Q56]

_____ 51 or more [Go to Q57]


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Q58. How many employees in total typically work at this facility during:


20 or fewer

21 to 100

101 to 500

501 to 750

751 to 1,000

1,001 or more

a.

Peak season?

b.

Off season?

Q59. What percent of your total employees are part-time or temporary during:


0%

5% or less


>5% to 10%


>10% to 25%

>25% to 50%


>50% to 75%

>75%

a.

Peak season?

b.

Off season?


Q60. Approximately, how many production line managers/supervisors do you employ during:


5 or fewer

6 to 10

11 to 30

31 to 50

51 or more

a.

Peak season?

b.

Off season?


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Q61.(*) Is this facility independently owned and operated or does your company own and operate other food manufacturing or processing facilities?

_____ Independently owned [Go to Q62]

_____ Company operates other facilities


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Q63. How many food manufacturing or processing facilities including this one does your company own and operate?

_____ 2 to 5

_____ 6 to 10

_____ 10 to 20

_____ Greater than 20


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Q64. For the most recent fiscal year, what was the gross sales revenue for the food manufactured or processed at this facility?

_____ $500,000 or less

_____ >$500,000 to $1 million

_____ >$1 million to $6 million

_____ >$6 million to $10 million

_____ >$10 million to $50 million

_____ >$50 million to $100 million

_____ >$100 million


[Programmer Note 3: If Q65 = “Yes,” go to Q66, otherwise go to Q67]


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TRAINING


Q68.(*) Which of the following best describes the type of food safety and sanitation training you provide for your newly hired hourly employees? Please check only one.

_____ Classroom-type training

_____ Supervised on-the-job training conducted by facility personnel

_____ Informal (not supervised) on-the-job training [Go to Q69]

_____ Self-administered training (such as supplemental reading materials, videotapes, online courses, etc.) [Go to Q70]

_____ No training program [Go to Q71]


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Q72. Does your food safety and training for newly hired hourly personnel cover the following areas?



Not applicable

Yes

No

a.

Principles of food safety hazards and prevention

b.

Personal hygiene practices

c.

Basic cleaning and sanitizing

d.

Allergen control

e.

Other GMP practices ____________[verbatim]


Q73. On average, about how many hours of food safety and sanitation training does a newly hired hourly employee receive?

_____ 4 hours or less

_____ >4 to 8 hours

_____ >8 to 16 hours

_____ >16 to 48 hours

_____ >48 hours

Q74.(*) Do you provide refresher training in food safety and sanitation to your hourly personnel?

_____ Yes

_____ No [Go to Q75]


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Q76. How often do you provide refresher training?

_____ Monthly

_____ Quarterly

_____ Semiannually

_____ Annually

_____ Other __________________________________ [verbatim]

Q77. What is the typical duration of your refresher-training sessions?

_____ 30 minutes or less

_____ >30 minutes to 1 hour

_____ >1 to 2 hours

_____ >2 to 4 hours

_____ >4 to 8 hours

_____ >8 hours


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Q78.(*) Approximately, what percentage of your hourly employees is able to read written procedures and training materials in English?

_____ 100 percent (All of our employees can read in English) [Go to Q79]

_____ 75 to 99 percent

_____ 50 to 74 percent

_____ 25 to 49 percent

_____ Less than 25 percent


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Q80. Please indicate the languages in which you provide food safety and sanitation training (including initial training provided upon hire and refresher training, if any) for your non-English speaking hourly personnel. Please check all that apply.

_____ Spanish

_____ Chinese

_____ Creole

_____ Korean

_____ Portuguese

_____ Vietnamese

_____ Thai

_____ Indigenous languages

_____ Other __________________________________ [verbatim]

_____ None (We do not provide training in any language but English)


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Q81. Apart from your hourly employees, about how many hours of food safety and sanitation training do the following types of personnel receive within the first year of employment?



None

4 hours or less

>4 to 8 hours

>8 to 16 hours

>16 to 48 hours

>48 hours

a.

Food production operation managers

b.

Production supervisors

c.

Quality control managers

d.

Sanitation and cleaning supervisors


Q82.(*) Approximately, how many hours of continuing training in food safety and sanitation do the following types of personnel receive annually?



None

4 hours or less

>4 to 8 hours

>8 to 16 hours

>16 to 48 hours

>48 hours

a.

Food production operation managers

b.

Production supervisors

c.

Quality control managers

d.

Sanitation and cleaning supervisors


[Programmer Note 4: If Q83a through Q84d = “None,” go to Q85, otherwise go to Q86 ]


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Q87. Which of the following types of ongoing training programs do you offer these personnel? Please check all that apply.

_____ Cross-training in various skills

_____ Tuition compensation for job-related outside courses

_____ Pay-for-skills program

_____ Industry short courses

_____ Other __________________________________ [verbatim]


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Q88. Do you maintain the following types of records related to food safety and sanitation training received by your employees?



Yes, for all employees

Yes, for all except hourly employees

Yes, for only hourly employees

No

a.

Documentation of administered training

b.

Documentation of the training content

c.

Proof of management oversight

d.

Corrective actions

e.

Other _________________[verbatim]


Q89. Which of the following methods do you use to assess the effectiveness of your food safety and sanitation training program? Please check all that apply.

_____ Formal employee testing with records of such tests

_____ Documented employee monitoring and performance evaluation

_____ Other __________________________________ [verbatim]

_____ Do not formally evaluate training effectiveness


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SANITATION AND PERSONAL HYGIENE


Q90.(*) Do you have written cleaning procedures for your food contact equipment?

_____ Yes

_____ No [Go to Q91]


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Q92. Do your procedures for cleaning of food contact equipment cover any of the following elements?



Yes

No

a.

Descriptions of specific steps for cleaning

b.

Frequency of cleaning

c.

Chemicals and cleaners to be used

d.

Descriptions for disassembling and reassembling equipment

e.

Personnel responsibilities for cleaning equipment


Q93. Have you validated these procedures?

_____ Yes

_____ No

_____ Don’t know


Q94. On average, how frequently do you clean your food contact equipment?

_____ After each production run

_____ More than once per shift

_____ Every shift

_____ Daily

_____ Weekly

_____ Monthly

_____ Other __________________________________[verbatim]


Q95. Which of the following methods do you use to clean your food contact equipment? Please check all that apply.

_____ Clean-in-place (CIP)

_____ Clean-out-place (COP)

_____ Push-through with product flush

_____ Push-through with inert-material flush

_____ Dry cleaning: scraping or brushing

_____ Dry cleaning: compressed air

_____ Dry cleaning: vacuum

_____ Wet cleaning: water with aqueous detergent

_____ Wet cleaning: water without aqueous detergent

_____ Wet cleaning: high-pressure washing

_____ Other __________________________________[verbatim]


Q96. Which of the following methods do you use to assess the effectiveness of your food contact equipment cleaning ?

_____ Test for chemical residue

_____ Test for microbial contamination

_____ ATP bioluminescence testing

_____ Other __________________________________[verbatim]

_____ None of the above


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Q97.(*) Do you have written sanitizing procedures for your food contact equipment?

_____ Yes

_____ No [Go to Q98]


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Q99. Do your procedures for sanitizing of food contact equipment cover any of the following elements?



Yes

No

a.

Descriptions of specific steps for sanitizing

b.

Frequency of sanitizing

c.

Chemicals and sanitizers to be used

d.

Descriptions for disassembling and reassembling equipment

e.

Personnel responsibilities for sanitizing equipment


Q100. Have you validated these procedures?

_____ Yes

_____ No

_____ Don’t know


Q101. On average, how frequently do you sanitize your food contact equipment?

_____ After each production run

_____ More than once per shift

_____ Every shift

_____ Daily

_____ Weekly

_____ Monthly

_____ Other __________________________________[verbatim]


Q102. Please indicate the types of sanitizers you use on your food contact equipment? Please check all that apply.

_____ Steam

_____ Hot water

_____ Ozone

_____ Chlorine-based sanitizers, such as chlorine gas, hypochlorites, or chloramines

_____ Chlorine dioxide (ClO2)

_____ Iodophors (or iodine compounds)

_____ Quarternary ammonium compounds mixed with water

_____ Quarternary ammonium compounds mixed with alcohol

_____ Acid anionic surfactants (mainly phosphoric acid combined with surface-active agents)

_____ Carboxylic acid (or fatty acid) sanitizers

_____ Peroxy compounds, such as hydrogen peroxide (HP) or peroxyacetic acid (PAA)

_____ Other __________________________________[verbatim]


Q103. Which of the following methods do you use to assess the effectiveness of your food contact equipment sanitizing?

_____ Test for chemical residue

_____ Test for microbial contamination

_____ ATP bioluminescence testing

_____ Other __________________________________[verbatim]

_____ None of the above


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Q104.(*) Do you have written cleaning procedures for your non-food contact equipment?

_____ Yes

_____ No [Go to Q105]


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Q106. On average, how frequently do you clean your non-food contact equipment?

_____ After each production run

_____ More than once per shift

_____ Every shift

_____ Daily

_____ Weekly

_____ Monthly

_____ Other __________________________________[verbatim]


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Q107.(*) Do you have written cleaning procedures for your production areas?

_____ Yes

_____ No [Go to Q108]


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Q109. On average, how frequently do you clean your production areas?

_____ After each production run

_____ More than once per shift

_____ Every shift

_____ Daily

_____ Weekly

_____ Monthly

_____ Other __________________________________[verbatim]


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Q110.(*) Do you have written cleaning procedures for your finished goods storage areas?

_____ Yes

_____ No [Go to Q111]


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Q112. On average, how frequently do you clean the finished goods storage areas at your facility?

_____ After each production run

_____ More than once per shift

_____ Every shift

_____ Daily

_____ Weekly

_____ Monthly

_____ Other __________________________________[verbatim]


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Q113. Do you have written cleaning procedures for your raw material storage areas?

_____ Yes

_____ No [Go to Q114]


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Q115. On average, how frequently do you clean your raw material storage areas?

_____ More than once per shift

_____ Every shift

_____ Daily

_____ Weekly

_____ Monthly

_____ Other __________________________________[verbatim]


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Q116.(*) Do you monitor microbial contamination through environmental sampling and testing?

_____ Yes, testing done in-house

_____ Yes, testing done by an outside laboratory

_____ Yes, testing done both in house and by an outside laboratory

_____ No [Go to Q117]

_____ Don’t know [Go to Q118]


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Q119.(*) Which of the following methods do you use to monitor microbial contamination? Please check all that apply.

_____ Conventional culture methods

_____ Rapid microbial detection systems

_____ ATP bioluminescence testing

_____ Other __________________________________[verbatim]


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Q120. How frequently do you monitor for microbial contamination?

_____ After each production run

_____ More than once per shift

_____ Every shift

_____ Daily

_____ Weekly

_____ Monthly

_____ Other __________________________________[verbatim]


Q121. Please indicate from the following, the personal hygiene practices for your production personnel. Please check all that apply.

_____ Employer-provided outer clothing

_____ Employer-provided uniform

_____ Employer-provided footwear

_____ Hair nets or restraints for head and facial hair

_____ Sanitary gloves

_____ Hand dips

_____ Footbaths

_____ Other __________________________________[verbatim]

Q122. Which of the following are your employee hand-washing requirements? Please check all that apply.

_____ Hand washing at the start of work

_____ Hand washing after breaks (e.g., eating, drinking, or smoking)

_____ Hand washing after using the restroom

_____ Hand washing after touching something unclean

_____ Hand washing after touching body parts

_____ Do not have an employee hand washing policy


Q123.(*) Do you have a pest control program?

_____ Yes, we have a written pest control program

_____ Yes, we have an unwritten pest control program

_____ No [Go to Q124]


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Q125. For which of the following types of pests do you control?

_____ Flying insects

_____ Food storage insects

_____ Birds

_____ Rodents

Q126. Which of the following best characterizes the inspections for assessing your applicable pest control program’s effectiveness?




Not applicable

Regular inspections required

Inspections conducted on an as needed basis

Inspections not required

a.

Flying insects


b.

Food storage insects


c.

Birds


d.

Rodents



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Q127. Does your water supply meet the U.S. Environmental Protection Agency’s (EPA’s) drinking water standards?

_____ Yes

_____ No

_____ Don’t know


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ALLERGEN CONTROLS


Q128.(*) Do you manufacture or process ingredients that are, or are derived from any of the following main (8) allergenic foods or food groups? Please check all that apply.

______ Soybean or soybean-based ingredients, including miso, tofu, and soy flour

______ Peanuts or peanut-based ingredients, including peanut butter and peanut flour

______ Fish, including fresh and saltwater finfish

______ Crustacea, including shrimp, lobster, crab, and crayfish

______ Tree nuts, including almonds, chestnuts, macadamia, pecans, walnuts, and hazelnuts

______ Milk, including butter, buttermilk, casein, cheese, cottage cheese, curds, whey, and caseinate

______ Eggs, including egg yolks, egg whites or albumin, mayonnaise, or meringue

______ Wheat, including bran, bread crumbs, farina, malt, wheat germ, wheat gluten, semolina, and spelt

______ None of the above [Go to Q129]

______ Don’t know [Go to Q130]


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Q131.(*) Do you also manufacture or process food ingredients or products that:


Yes

No

Don’t know

a.

Do not contain any of the main eight (8) allergens identified in Question 132 above, i.e., products that are allergen free?

b.

Foods that contain various mixes of different allergens listed in Question 133, such as a candy bar with peanuts and a candy bar with almonds?


[Programmer Note 5: If Q134a or Q135b=“Yes,” continue; otherwise go to Q136]


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Q137.(*) Do you have a written plan for the control of allergens?

______ Yes

______ No [Go to Q138]


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Q139. Of the following manufacturing or process issues, please identify those that are addressed by your written plan. Please check all that apply.

______ New product development

______ Product reformulation

______ Receipt of raw materials

______ Storage of raw materials

______ Handling of raw materials

______ Cleaning of food contact equipment

______ Sharing of food contact equipment between allergen and non allergen containing products

______ Cleaning of environmental surfaces

______ Production sequencing/scheduling

______ Workflow

______ Labeling finished products

______ Testing for allergen residues on food contact equipment surfaces

______ Testing for allergen residues elsewhere

______ Storage and handling of packaging materials

______ Rework storage

______ Rework handling

______ Other __________________________________ [verbatim]


Q140. Which, if any, of the following procedures do you use to reduce the cross contact of allergen-free with allergen-containing products or between products with different allergens? Please check all that apply.

______ Clean between production runs of allergen-containing products and allergen-free products or between production runs of products with different mixes of allergens

______ Utilize dedicated, separate equipment and production lines for allergen-containing and allergen-free products or for products with different mixes of allergen containing products

______ Schedule production runs for allergen-containing products at the end of the day or production period

______ Separate maintenance tools and utensils for allergen-free and allergen-containing products

______ Change the protective clothing for employees, including gloves, aprons, and uniforms between production runs

______ Other __________________________________ [verbatim]

______ None of the above


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Q141. Do you have an air filtration system for your production areas that is capable of removing airborne allergen particles?

______ Yes

______ No


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Raw Materials, In-process Materials, and Rework


Q142. Which of the following describes how your allergen-containing raw materials are stored and handled? Please check all that apply.

______ Marked or color-coded storage bins for allergen-containing raw materials

______ Dedicated storage bins for allergen-containing raw material use only

______ Separate storage room for allergen-containing raw materials

______ Separate area, such as a dedicated rack, for allergen-containing raw materials in the same storage room with other raw materials

______ Storage of like above like on storage racks

______ Storage of allergen-containing materials on the bottom rack

______ Dedicated scoops and utensils for handling allergen-containing raw materials

______ Other __________________________________ [verbatim]

______ None of the above


Q143. Do you require any of the following from your raw material suppliers? Please check all that apply.

______ Written plan for the control of allergens

______ Certificates of analysis (COA) or letters of guarantee

______ Detailed ingredient lists (e.g., artificial colors, flavors, or incidental additives)

______ Prior notification of product formulation changes in writing

______ Other __________________________________ [verbatim]

______ None of the above


Q144. Do you test your raw materials for allergens? Please check only one.

______ Yes, each incoming lot

______ Yes, periodically using a statistical sampling plan

______ Yes, sporadically when the need arises

______ No


Q145. Which of the following describes how your allergen-containing in-process materials are stored and handled? Please check all that apply.

______ Marked or color-coded storage bins for allergen-containing in-process materials

______ Dedicated storage bins for allergen-containing in-process materials use only

______ Separate storage room for allergen-containing in-process materials

______ Separate area, such as a dedicated rack, for allergen-containing in-process materials in the same storage room with other in-process materials

______ Storage of like above like on storage racks

______ Storage of allergen-containing materials on the bottom rack

______ Dedicated scoops and utensils for handling allergen-containing in-process materials

______ Other __________________________________ [verbatim]

______ None of the above


Q146. Which of the following describes how your allergen-containing rework are stored and handled? Please check all that apply.

______ Marked or color-coded storage bins for allergen-containing rework

______ Dedicated storage bins for allergen-containing rework use only

______ Separate storage room for allergen-containing rework

______ Separate area for allergen-containing rework in the same storage room with other raw materials and/or rework

______ Use rework with the same run only

______ Rework like into like only

______ Track rework to document how it is eventually used

______ Other __________________________________ [verbatim]

______ None of the above


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Testing


Q147. Which of the following methods do you use to monitor the effectiveness of your cleaning to remove allergenic residue from food contact surfaces? Please check all that apply.

______ Visual inspection

______ Commercially available enzyme linked immunosorbent assay (ELISA) allergen test kit

______ Other __________________________________ [verbatim]

______ We do not monitor the effectiveness of our cleaning for allergenic residues


Q148. Please indicate the frequency with which you conduct the following testing to ensure the absence of specific allergens?


Not applicable

Each batch is tested

Statistical batch sampling

Other

Don’t know

a.

Finished-product testing

b.

In-process testing


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Labeling


Q149. Do you have written procedures for label review to ensure that all of the allergenic ingredients are accurately identified in your ingredient statements?

______ Yes

______ No

Q150.(*) Do you have written procedures for the reconciliation of the number of labels issued and the number of labels used?

______ Yes

______ No [Go to Q151]


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Q152. Do your written procedures include any of the following? Please check all that apply.

______ Verification that labels are correctly printed

______ Verification that labels match their intended products at the beginning of every production run

______ Verification that labels match their intended products at the end of every production run

______ Other __________________________________ [verbatim]


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Q153. Do any of your finished product labels contain any of the following or similar versions of advisory labeling for allergenic ingredients? Please check all that apply.

______ May contain “_______.”

______ May contain traces of “_______.”

______ Has been processed on equipment that is also used to process “_______.”

______ Processed in a plant that also processes “_______.”

______ Other __________________________________ [verbatim]

______ We do not use any advisory labeling.


Q154. Within the last 12 months, approximately how many of your product batches were rejected due to incorrect labeling of allergenic ingredients or presence of allergenic ingredients in products that were not intended to contain them?

______ batches were rejected because of incorrect labeling

______ batches were rejected because of the presence of allergenic ingredients in products


[Programmer Note 6: Restrict Q155 to be between 0 and 10,000. If entry is out of range, prompt user.]


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PROCESS CONTROLS


Raw Materials and Ingredients


Q156. Do you have written procedures for receiving and handling incoming raw materials, ingredients, and other components?

_____ Yes

_____ No

Q157.(*) Do you have written procedures for approving vendors of raw materials, ingredients, and other components?

_____ Yes

_____ No [Go to Q158]


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Q159.(*) Do you ever use raw materials, ingredients and/or other components supplied by other than approved vendors?

_____ Yes

_____ No [Go to Q160]


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Q161. Within the last 12-month period, approximately what percentage of your vendors were not approved?

_____ 5 percent or less

_____ >5 to 10 percent

_____ >10 to 25 percent

_____ >25 percent


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Q162. Which of the following methods do you use to approve your raw materials, ingredients, and other components? Please check all that apply.

_____ Conduct vendor audits at the vendor’s location

_____ Request independent auditor’s evaluation

_____ Require Certificates of Analyses (COAs)

_____ Require Letters of Guarantee

_____ Rely on vendor reputation

_____ Other _______________________________________ [verbatim]

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Q163.(*) Do you have written procedures to ensure the condition of incoming raw materials, ingredients and other components?

_____ Yes

_____ No [Go to Q164]


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Q165. Do your written procedures require any of the following inspections or analyses? Please check all that apply.

_____ Visual inspection

_____ Chemical analysis

_____ Foreign material contamination checks

_____ Microbiological evaluation

_____ Review of Certificates of Analyses and/or Letters of Guarantee

_____ Other _______________________________________ [verbatim]

_____ Our written procedures do not require inspections or analyses


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Process and Product Evaluation


Q166. Approximately, how many finished product batches did you produce in the last 12 months?

______ batches


Q167. Approximately, how many of these finished product batches were rejected due to safety and quality problems, such as microbiological contamination and mislabeling, in the last 12 months?

______ batches


Q168.(*) Do you have a Hazard Assessment and Critical Control Point (HACCP) system ?

_____ Yes

_____ No [Go to Q169]


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Q170. Is your HACCP system currently certified by any of the following third parties? Please check all that apply.

_____ Do not use a third party for HACCP system certification

_____ NSF International

_____ Silliker Laboratories

_____ International Dairy Foods Association (IDFA)

_____ American Society for Quality (ASQ)

_____ American Institute of Baking (AIB)

_____ Other _______________________________________ [verbatim]


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Q171. Do you have ISO 9000 certification?

_____ Yes

_____ No

Q172. Do you have written procedures that specify your operational control practices for ensuring product safety and quality?

_____ Yes

_____ No


Q173. Which, if any, of the following types of operational control systems do you use?

_____ Programmable logic controller (PLCs)

_____ Statistical process controller (SPC)

_____ Material-requirements planning system (MRP)

_____ Manufacturing-resource planning system (MRPII)

_____ Supervisory Control and Data Acquisition (SCADA)

_____ Manufacturing execution system (MES)

_____ Predictive control system

_____ Other _______________________________________ [verbatim]

_____ We do not use operational control systems


Q174. Do you use statistical methods to evaluate data collected from operational control points?

_____ Yes

_____ No


Q175. Do you have written procedures for the routine calibration of operating equipment and measuring devices?

_____ Yes, for all devices

_____ Yes, for some devices

_____ No


Q176. Do you conduct in-process testing to ensure product safety?

_____ Yes

_____ No


Q177.(*) Do you conduct finished-product testing to ensure safety?

_____ Yes

_____ No [Go to Q178]


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Q179. Which of the following best describes your finished-product testing program?

_____ Each finished-product lot is tested

_____ Statistical lot sampling

_____ Other _______________________________________ [verbatim]


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Validation


Q180. Do you use any of the following techniques to validate the effectiveness of your pathogen control measures? Please check all that apply.

_____ Rely on previous validation studies or historical knowledge of the effectiveness of essential control measures

_____ Receive documentation from equipment manufacturer

_____ Conduct a challenge study

_____ Conduct culture-ID studies to identify pathogen strains present in the processing environment

_____ Use independently recognized process authority

_____ Other _______________________________________ [verbatim]

_____We do not validate the effectiveness of our pathogen control measures.


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Audits


Q181.(*)Apart from routine sanitation inspections, do you or others also conduct audits of your food safety control systems?

_____ Yes

_____ No [Go to Q182]


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Q183. Who typically requires these audits? Please check all that apply.

_____ Your plant management

_____ Your insurance company

_____ Your retail customers

_____ International government agencies

_____ State/local governments

_____ Other _______________________________________ [verbatim]


[Programmer Note 7: If Q184 = “Your retail customers,” go to Q185, otherwise go to Q186]


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Q187. Which of the following retail customers typically require these audits? Please check all that apply.

_____ Supermarkets

_____ Restaurants

_____ Military

_____ Schools

_____ Other _______________________________________ [verbatim]


Q188. Who typically performs your audits? Please check all that apply.

_____ Your QC or other specialized personnel

_____ Your customers or another independent 2nd party

_____ Specialized GMP auditors or another 3rd party contractor

_____ Your insurance company’s auditors

_____ Other _______________________________________ [verbatim]


Q189. What is the frequency of these audits?

_____ Quarterly

_____ Semi-annually

_____ Annually

_____ Randomly

_____ Other _______________________________________ [verbatim]


Q190. Which of the following areas do these audits typically cover? Please check all that apply.

_____ Administrative procedures

_____ Operational procedures

_____ Allergen control program

_____ Personnel

_____ Equipment

_____ Calibration

_____ Label design

_____ Label production procedures

_____ Material resources

_____ Environmental conditions of processing areas

_____ Manufacturing processes

_____ Product conformance

_____ Documentation and recordkeeping

_____ Consumer complaints

_____ Other _______________________________________ [verbatim]


Q191. In addition to the above, are you also audited against any of the following standards? Please check all that apply.

_____ USDA National Organic Program (NOP) Standard

_____ European Union (EU) Organic Standard

_____ European Union (EU) Directive on Genetically Modified Food and Feed

_____ Food Standards Australia New Zealand (FSANZ) Genetically Modified Food Standard

_____ Other _______________________________________ [verbatim]


Q192. In which of the following ways do you use the results from your audits? Please check all that apply.

_____ To conduct a trend analysis of changes in food safety measures

_____ To identify areas for corrective actions

_____ Other _______________________________________ [verbatim]


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RECORDKEEPING


Q193. Do you regularly maintain the following types of buildings and facilities records?



Yes, some

Yes, all

No

a.

Plant design review records

b.

Environmental monitoring records



Q194. Do you regularly maintain the following types of equipment and utensils records?



Yes, some

Yes, all

No

a.

Equipment maintenance records

b.

Equipment cleaning and sanitation records



Q195. Do you regularly maintain the following types of materials records?



Yes, some

Yes, all

No

a.

Supplier qualification records

b.

Incoming raw material inspection records


Q196. Do you regularly maintain the following types of personnel records?



Yes, some

Yes, all

No

a.

Plant personnel records

b.

Consultant/contractor records


Q197. Do you regularly maintain the following types of production and process controls records?



Yes, some

Yes, all

No

a.

Production process records

b.

Sampling and testing records

c.

Planned and unplanned process deviation records


Q198. Do you regularly maintain the following types of QA/QC and laboratory operations records?



Yes, some

Yes, all

No

a.

Analytical testing records

b.

Verification records

c.

Consumer complaints


Q199. Do you regularly maintain the following types of validation records?



Yes, some

Yes, all

No

a.

Equipment validation records

b.

Process validation records

c.

Cleaning validation records


Q200. Do you regularly maintain the following warehousing and distribution records?



Yes, some

Yes, all

No

a.

Warehousing and storage records

b.

Shipment and distribution records


Q201. On average, how long do you retain your records?

_____ Less than a year

_____ One year

_____ One to two years

_____ Two to three years

_____ Three to five years

_____ More than five years

_____ Indefinitely

_____ Other _______________________________ [verbatim]


Q202. If FDA were to modernize the GMPs, on average, how much total management time would be necessary to review the new FDA requirements for training, SSOPs, process controls, recordkeeping and allergen controls to determine whether your existing procedures are adequate or whether modifications/additions might be necessary?

_____ Less than 1 day

_____ 1 day to 1 week

_____ 1 week to 2 weeks

_____ 2 weeks to 4 weeks

_____ 4 weeks or more


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TRAINING (Fresh Produce)


Q203.(*)Which of the following best describes the type of food safety and sanitation training you provide for your newly hired personnel? Please check only one per row.



Classroom-type

Supervised on-the-job

Informal (not supervised) on-the-job

Self-administered

No training program

Not applicable

a.

Permanent supervisors

b.

Permanent packing line employees

c.

Seasonal employees


[Programmer Note 8: If Q204a or Q205b or Q206c =“Classroom-type training” or “Supervised on-the-job training conducted by facility personnel,” continue, otherwise go to Q207]


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Q208. Does your food safety and sanitation training for newly hired employees cover the following areas?



Yes

No

a.

Microbial contamination prevention

b.

Reporting illnesses and injuries to supervisors

c.

Use of toilet facilities

d.

Proper hand washing

e.

Personal cleanliness and hygiene

f.

Facility cleaning

g.

Equipment cleaning

h.

Equipment sanitizing

i.

Product handling

j.

Other practices _________________[verbatim]


Q209. On average, about how many hours of food safety and sanitation training does a newly hired employee receive? Please check only one per column.



None

Not applicable

<5 hours

5-8 hours

>8-16 hours

>16-48 hours

>48 hours

a.

Permanent supervisors

b.

Permanent packing line employees

c.

Seasonal employees


Q210. Do you utilize signage in your packing facility to reinforce training concepts, such as hand washing, personal cleanliness, and product handling?

_____ Yes

_____ No


Q211.(*)Approximately, what percentage of your packing facility employees is able to read written procedures and training materials in English?

_____ 100 percent (All of our employees can read in English) [Go to Q212]

_____ 75 to 99 percent

_____ 50 to 74 percent

_____ 25 to 49 percent

_____ Less than 25 percent


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Q213. Please indicate the languages in which you provide food safety and sanitation training (including initial training provided upon hire and refresher training, if any) for your non-English speaking packing facility employees. Please check all that apply.

_____ Spanish

_____ Chinese

_____ Creole

_____ Korean

_____ Portuguese

_____ Vietnamese

_____ Thai

_____ Indigenous languages

_____ Other __________________________________ [verbatim]

_____ None (We do not provide training in any language but English)


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Q214. Do you maintain the following records related to food safety and sanitation training received by your packing facility employees?



a. Permanent supervisors

b. Permanent packing line employees

c. Seasonal employees



Yes

No

Yes

No

Yes

No

a.

Documentation of administered training

b.

Documentation of the training content

c.

Proof of management oversight

d.

Corrective actions

e.

Other _________________[verbatim]


Q215. Which of the following methods do you use to assess the effectiveness of your food safety and sanitation training program? Please check all that apply.

_____ Formal employee testing with records of such tests

_____ Documented employee monitoring and performance evaluation

_____ Other __________________________________ [verbatim]

_____ Do not formally evaluate training effectiveness


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SANITATION AND PERSONAL HYGIENE (Fresh Produce)


Q216. Do you have written cleaning procedures applicable to various areas of your packing facility?

_____ Yes

_____ No

Q217. Do you have written sanitizing procedures applicable to various areas of your packing facility?

_____ Yes

_____ No

Q218. Which of the following best describes the type of restroom facilities for your packing facility employees? Please check only one.

_____ Permanent restroom with a hand washing facility

_____ Permanent restroom without a hand washing facility

_____ Temporary restroom with a hand washing facility

_____ Temporary restroom without a hand washing facility

_____ Hand washing facility but no restroom

_____ No restroom or hand washing facility

Q219. Do you have written standard operating procedures and/or schedules for the following tasks associated with the upkeep of your restroom and hand washing facilities? Please check all that apply.

_____ Cleaning the restroom

_____ Cleaning the hand washing facility

_____ Stocking paper towels

_____ Stocking toilet paper

_____ Stocking liquid soap

_____ Stocking drinking cups

_____ Trash removal

_____ Sewage disposal

_____ Other __________________________________ [verbatim]

_____ Do not have written procedures on restroom or hand washing facility upkeep


Q220. Which of the following are your employee hand-washing requirements? Please check all that apply.

_____ Hand washing at the start of work

_____ Hand washing after breaks (e.g., eating, drinking, or smoking)

_____ Hand washing after using the restroom

_____ Hand washing after touching something unclean

_____ Hand washing after touching body parts

_____ Do not have an employee hand washing policy


Q221.(*)Do you have written standard operating procedures and/or schedules for the following tasks? Please check all that apply.

_____ Container inspection [Go to Q222]

_____ Changing post harvest water in dump/wash tanks, if applicable [Go to Q223]

_____ Changing post harvest water in cooling units, if applicable [Go to Q224]

_____ Pest control

_____ None of the above [Go to Q225]


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Q226. For which of the following types of pests do you control? Please check all that apply.

_____ Insects

_____ Birds

_____ Rodents/small animals

_____ Reptiles/amphibians

_____ Other __________________________________ [verbatim]

_____ None of the above


Q227. Do you periodically evaluate the effectiveness of your pest control policy and make changes as needed?

_____ Yes

_____ No


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Q228. Please indicate whether you have written policies addressing the following areas? Please check all that apply.

_____ Exclusion of domestic animals from the packing and storage areas

_____ Exclusion of children from the packing and storage areas

_____ Exclusion of ill workers from direct contact with fresh produce

_____ None of the above

Q229.(*)Please indicate from the following, the personal hygiene practices for your packing facility personnel. Please check all that apply.

_____ Employer-provided outer clothing (e.g., aprons or mocks)

_____ Employer-provided uniform

_____ Employer-provided footwear

_____ Hair nets or restraints for head and facial hair

_____ Sanitary gloves

_____ Hand dips

_____ Footbaths

_____ Other __________________________________[verbatim]

_____ None of the above


[Programmer Note 9: If Q230 = “Sanitary gloves”, go to Q231; otherwise go to Programmer Note 10]


[Programmer Note 11: If Q232 = “Field with some processing and water contact (e.g., significant trimming, coring, washing, and cooling)” or “Packing in a physical structure with some post harvest processing with water contact (e.g., trimming, coring, washing, waxing, and cooling),” go to Q233, otherwise go to END2]


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Q234. Which of the following characterizes the use of sanitary gloves at your packing facility? Please check all that apply.

_____ Employees handling fresh produce wear gloves

_____ Company provides and maintains disposable gloves

_____ Company provides and maintains non-disposable gloves

_____ Non-disposable gloves are maintained by the employee


[Programmer Note 12: If Q235 = “Field with some processing and water contact (e.g., significant trimming, coring, washing, and cooling)” or “Packing in a physical structure with some post harvest processing with water contact (e.g., trimming, coring, washing, waxing, and cooling),” go to Q236, otherwise go to END2]


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PROCESS CONTROLS (Fresh Produce)


Water Quality


Q237. What is the source for your post harvest processing water? Please check only one.

_____ Municipal water

_____ Well water

_____ Surface water

_____ Other __________________________________[verbatim]


Q238. How frequently do you test your post harvest processing water for the following indicator organisms and/or pathogens?


Never

Less than once per year

Annually

Quarterly

Monthly

Daily

Total coliform bacteria

Fecal coliform bacteria

Generic E. coli

E. coli O157:H7

Salmonella spp.

Cryptosporidium parvum


Q239. Do you have backflow and vacuum breaker valves to prevent backflow and contamination of your water supply?

_____ Yes

_____ No


Q240.(*)What type of disinfectant do you use for your post harvest processing water? Please check only one.

_____ Chlorine (sodium hypochlorite, calcium hypochlorite, or chlorine gas)

_____ Chlorine dioxide

_____ Peroxyacetic acid [Go to Q241]

_____ Ozone [Go to Q242]

_____ Other __________________________________[verbatim] [Go to Q243]

_____ None of the above [Go to Q244]


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Q245. How frequently do you monitor the following during post harvest processing?



Not applicable

Never

Weekly

Daily

Hourly

Continuously

a.

Total chlorine

b.

Free chlorine

c.

Oxidation reduction potential (ORP)

d.

PH

e.

Temperature


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Q246. Which of the following methods do you use for maintaining the disinfectant concentration of your post harvest processing water? Please check all that apply.


Automatic

Manual

a.

Disinfectant concentration monitoring

b.

pH monitoring

c.

Addition of disinfectant to water

d.

pH adjustment


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RECORDKEEPING


Q247. Please indicate whether you maintain a log or other records for the following?



Not applicable

Yes

No

a.

Wash water disinfectant concentration

b.

Wash water oxidation reduction potential (ORP)

c.

Wash water pH

d.

Wash water temperature

e.

Cooling water disinfectant concentration

f.

Cooling water oxidation reduction potential (ORP)

g.

Cooling water pH

h.

Cooling water temperature


Q248. Do you keep the following records about your incoming materials?


Yes

No

a.

Field

b.

Harvest date

c.

Type of produce

d.

Volume of produce


Q249. Do you label your outgoing produce with lot codes or other marks that could facilitate traceback and recall in the event of a problem?

_____ Yes

_____ No


Q250. If FDA were to modernize the GMPs, on average, how much total management time would be necessary to review the new FDA requirements for training, SSOPs, process controls, and recordkeeping to determine whether your existing procedures are adequate or whether modifications/additions might be necessary?

_____ Less than 1 day

_____ 1 day to 1 week

_____ 1 week to 2 weeks

_____ 2 weeks to 4 weeks

_____ 4 weeks or more


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SURVEY EXIT


END1: Given your operations, we have determined that the remaining questions are not applicable to your facility. [Go to END2]


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END2: Thank you very much for your time. Please click on the “Submit Survey” button to submit your survey. If you would like to make changes to your responses before submitting, please use the “Previous Page” button.


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Drop-down 1

-Select-

Animal Slaughtering & Processing

Bakeries & Tortilla Manufacturing-Retail Bakeries

Bakeries & Tortilla Manufacturing-Commercial Bakeries

Bakeries & Tortilla Manufacturing-Frozen Cakes, Pies, & Other Pastries Manufacturing

Bakeries & Tortilla Manufacturing-Cookie & Cracker Manufacturing

Bakeries & Tortilla Manufacturing-Flour Mixes & Dough Manufacturing from Purchased Flour

Bakeries & Tortilla Manufacturing-Dry Pasta Manufacturing

Bakeries & Tortilla Manufacturing-Tortilla Manufacturing

Beverage Manufacturing-Soft Drink Manufacturing

Beverage Manufacturing-Bottled Water Manufacturing

Beverage Manufacturing-Ice Manufacturing

Beverage Manufacturing-Breweries

Beverage Manufacturing-Wineries

Beverage Manufacturing-Distilleries

Dairy Product Manufacturing-Fluid Milk Manufacturing

Dairy Product Manufacturing-Creamery Butter Manufacturing

Dairy Product Manufacturing-Cheese Manufacturing

Dairy Product Manufacturing-Dry, Condensed, & Evaporated Dairy Product Manufacturing

Dairy Product Manufacturing-Ice Cream & Frozen Desert Manufacturing

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Frozen Fruit, Juice, & Vegetable Manufacturing

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Frozen Specialty Food Manufacturing

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Fruit & Vegetable Canning

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Specialty Canning

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Dried & Dehydrated Food Manufacturing

Grain & Oilseed Milling-Flour Milling

Grain & Oilseed Milling-Rice Milling

Grain & Oilseed Milling-Malt Manufacturing

Grain & Oilseed Milling-Wet Corn Milling

Grain & Oilseed Milling-Soybean Processing

Grain & Oilseed Milling-Other Oilseed Processing

Grain & Oilseed Milling-Fats & Oils Refining & Blending

Grain & Oilseed Milling-Breakfast Cereal Manufacturing

Postharvest Crop Activities

Seafood Product Preparation & Packaging-Seafood Canning

Seafood Product Preparation & Packaging-Fresh & Frozen Seafood Processing

Sugar & Confectionery Product Manufacturing-Sugarcane Mills

Sugar & Confectionery Product Manufacturing-Cane Sugar Refining

Sugar & Confectionery Product Manufacturing-Beet Sugar Manufacturing

Sugar & Confectionery Product Manufacturing-Chocolate & Confectionery Manufacturing from Cacao Beans

Sugar & Confectionery Product Manufacturing-Confectionery Manufacturing from Purchased Chocolate

Sugar & Confectionery Product Manufacturing-Nonchocolate Confectionery Manufacturing

Other Food Manufacturing-Roasted Nuts & Peanut Butter Manufacturing

Other Food Manufacturing-Other Snack Food Manufacturing

Other Food Manufacturing-Coffee & Tea Manufacturing

Other Food Manufacturing-Flavoring Syrup & Concentrate Manufacturing

Other Food Manufacturing-Mayonnaise, Dressing, & Other Prepared Sauce Manufacturing

Other Food Manufacturing-Spice & Extract Manufacturing

Other Food Manufacturing-Perishable Prepared Food Manufacturing

Other Food Manufacturing-All Other Miscellaneous Food Manufacturing


Drop-down 2

-Select-

None

Animal Slaughtering & Processing

Bakeries & Tortilla Manufacturing-Retail Bakeries

Bakeries & Tortilla Manufacturing-Commercial Bakeries

Bakeries & Tortilla Manufacturing-Frozen Cakes, Pies, & Other Pastries Manufacturing

Bakeries & Tortilla Manufacturing-Cookie & Cracker Manufacturing

Bakeries & Tortilla Manufacturing-Flour Mixes & Dough Manufacturing from Purchased Flour

Bakeries & Tortilla Manufacturing-Dry Pasta Manufacturing

Bakeries & Tortilla Manufacturing-Tortilla Manufacturing

Beverage Manufacturing-Soft Drink Manufacturing

Beverage Manufacturing-Bottled Water Manufacturing

Beverage Manufacturing-Ice Manufacturing

Beverage Manufacturing-Breweries

Beverage Manufacturing-Wineries

Beverage Manufacturing-Distilleries

Dairy Product Manufacturing-Fluid Milk Manufacturing

Dairy Product Manufacturing-Creamery Butter Manufacturing

Dairy Product Manufacturing-Cheese Manufacturing

Dairy Product Manufacturing-Dry, Condensed, & Evaporated Dairy Product Manufacturing

Dairy Product Manufacturing-Ice Cream & Frozen Desert Manufacturing

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Frozen Fruit, Juice, & Vegetable Manufacturing

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Frozen Specialty Food Manufacturing

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Fruit & Vegetable Canning

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Specialty Canning

Fruit & Vegetable Preserving & Specialty Food Manufacturing-Dried & Dehydrated Food Manufacturing

Grain & Oilseed Milling-Flour Milling

Grain & Oilseed Milling-Rice Milling

Grain & Oilseed Milling-Malt Manufacturing

Grain & Oilseed Milling-Wet Corn Milling

Grain & Oilseed Milling-Soybean Processing

Grain & Oilseed Milling-Other Oilseed Processing

Grain & Oilseed Milling-Fats & Oils Refining & Blending

Grain & Oilseed Milling-Breakfast Cereal Manufacturing

Postharvest Crop Activities

Seafood Product Preparation & Packaging-Seafood Canning

Seafood Product Preparation & Packaging-Fresh & Frozen Seafood Processing

Sugar & Confectionery Product Manufacturing-Sugarcane Mills

Sugar & Confectionery Product Manufacturing-Cane Sugar Refining

Sugar & Confectionery Product Manufacturing-Beet Sugar Manufacturing

Sugar & Confectionery Product Manufacturing-Chocolate & Confectionery Manufacturing from Cacao Beans

Sugar & Confectionery Product Manufacturing-Confectionery Manufacturing from Purchased Chocolate

Sugar & Confectionery Product Manufacturing-Nonchocolate Confectionery Manufacturing

Other Food Manufacturing-Roasted Nuts & Peanut Butter Manufacturing

Other Food Manufacturing-Other Snack Food Manufacturing

Other Food Manufacturing-Coffee & Tea Manufacturing

Other Food Manufacturing-Flavoring Syrup & Concentrate Manufacturing

Other Food Manufacturing-Mayonnaise, Dressing, & Other Prepared Sauce Manufacturing

Other Food Manufacturing-Spice & Extract Manufacturing

Other Food Manufacturing-Perishable Prepared Food Manufacturing

Other Food Manufacturing-All Other Miscellaneous Food Manufacturing


Definition 1: By food safety and sanitation training, we mean training to teach employees concepts and practices for keeping food free of biological, chemical, and physical hazards, including allergenic ingredients and materials. By definition, this training does not include other types of training, such as job-specific and health and safety training that you may provide hourly personnel upon hire.


Definition 2: By newly hired hourly personnel, we mean any production line employee who has worked at the facility for less than four (4) weeks.


Definition 3: By refresher training, we mean training designed to refresh and/or enhance the initial food safety and sanitation training provided to newly hired personnel.


Definition 4: By continuing training, we mean training designed to refresh and/or enhance the initial food safety and sanitation training provided to newly hired personnel. This includes the time spent in conferences and workshops, if any.


Definition 5: By cross-training, we mean training an employee in another activity related to their current work.


Definition 6: By pay-for-skills program, we mean relating the pay of an employee to the acquisition of various job-related skills, thereby rewarding employees for enhancing their value to the organization.


Definition 7: By industry short courses, we mean such courses offered by organizations, such as the American Institute of Baking (AIB), Food Processors Institute (FBI), and others.


Definition 8: By validation, we mean the process of ensuring that a defined set of control measures is capable of achieving appropriate control over a specific hazard or hazards associated with an activity. Validation is typically conducted prior to the initiation of an activity, such as cleaning, and repeated only infrequently when significant changes are instituted, such as changes in cleaning agents. Validation is not the ongoing process of monitoring whether an activity is being carried out properly.


Definition 9: By production areas, we mean those areas where food contact equipment is located, including the floors, walls, drains, etc.


Definition 10: By environmental sampling and testing, we mean a systematic collection and testing of swab samples for pathogens, such as Listeria and Salmonella, for the purpose of monitoring the quality of one’s production areas, including food contact surfaces and non contact surfaces such as floors, drains, equipment, walls ceilings and more.


Definition 11: Spelt is a sub-specie of common wheat grown mostly in Europe.


Definition 12: By allergen free, we mean a finished food product that does not contain any of the following eight (8) allergens or proteins from them: soybean or soybean-based ingredients, peanuts or peanut-based ingredients, fish, crustacea, tree nuts, milk, eggs, and wheat.


Definition 13: By allergen control plan, we mean a systematic and documented method for identifying and controlling allergens at a food processing facility.


Definition 14: By rework, we mean clean, unadulterated food that has been (1) removed from processing for reasons other than insanitary conditions or (2) successfully reconditioned by reprocessing and that is suitable for use as food.


Definition 15: By label review, we mean a formal review of product label for conformance to current labeling regulations regarding product name, net weight, ingredient listing, manufacturer/distributor name and address, nutrition information, any health claims, product coding, and any statements related to product storage.


Definition 16: By batch, we mean a production run that can be isolated from other runs and identified with a specific set of material, production facility, and process characteristics. A batch may consist of one or more production lots each of which having a unique code (i.e., lot code).


Definition 17: By Hazard Assessment and Critical Control Point (HACCP) system, we mean a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles: (1) Conduct a hazard analysis. (2) Determine the critical control points (CCPs). (3) Establish critical limits. (4) Establish monitoring procedures. (5) Establish corrective actions. (6) Establish verification procedures. (7) Establish record-keeping and documentation procedures.


Definition 18: By in-process testing, we mean inline testing of materials during manufacturing, such as the continuous monitoring of throughput for metal particles with a metal detector incorporated into a processing or packaging line.


Definition 19: By finished-product testing, we mean systematic laboratory testing of the finished product according a predefined plan for pathogens, allergens, chemicals, and/or physical contaminants.


Definition 20: By food safety control system audit, we mean a thorough assessment of all food safety systems in a facility, including but not limited to administrative procedures, operational procedures, allergen control program, personnel, equipment, calibration, material resources, environmental conditions of processing areas, processes, product conformance, documentation and recordkeeping, and consumer complaints.


Definition 21: By newly hired personnel, we mean any employee who has worked at the facility for less than four (4) weeks.


Definition 22: By plant design review records, we mean routine and non-routine service logs and pest control service records.


Definition 23: By environmental monitoring records, we mean environmental sampling and testing records.


Definition 24: By equipment maintenance records, we mean maintenance logs, maintenance work and repair orders, equipment calibration master logs, and calibration compliance reviews.


Definition 25: By equipment cleaning and sanitation records, we mean equipment cleaning and sanitation logs, cleaning schedules, sanitation plans and procedures.


Definition 26: By supplier qualification records, we mean supplier certification records, supplier guarantees, certificates of analyses, and records of on-site supplier inspections.


Definition 27: By incoming raw material inspection records, we mean material review records (net-weight verification, label-to-product conformance checks, lot numbers, expiration dates), ingredient examination and testing records, sampling records (for testing purposes), packaging and supplies labeling reviews, disposition records (quarantine, approve, or reject), and records of non-conforming materials.


Definition 28: By plant personnel records, we mean employee background records, employee training records, employee training audits, and employee performance reviews.


Definition 29: By consultant/contractor records, we mean records of consultant and/or contractor qualifications.


Definition 30: By production process records, we mean master manufacturing records, production batch records, records of manufacturing process parameters (time, temperature, pressure, humidity, light), and CCP monitoring records.


Definition 31: By sampling and testing records, we mean in-process sampling and testing records for identity and for contamination.


Definition 32: By planned and unplanned process deviation records, we mean records of routing changes, corrective actions, and reprocessing and rework records.


Definition 33: By analytical testing records, we mean test method protocols, sampling plans, sample receipt protocol and checklists, test data for incoming ingredients, in-process materials, and finished products, test result review logs, and records of product deviations from standards.


Definition 34: By verification records, we mean internal and/or third-party audit records, document review logs, annual product reviews, material and ingredient reviews, and product recall reviews.


Definition 35: By consumer complaints, we mean consumer complaint data and records of records of corrective actions in response to complaints.


Definition 36: By equipment validation records, we mean equipment design, installation, operation, and performance qualification records.


Definition 37: By process validation records, we mean records of CCP determinations and manufacturing process scientific and technical documentation.


Definition 38: By cleaning validation records, we mean records of cleaning validation protocols for equipment, utensils, cleaning agents, and facility.


Definition 39: By warehousing and storage records, we mean records of storage procedures, warehouse temperature and humidity control records, and inventory logs.


Definition 40: By shipment and distribution records, we mean procedures and records for forward and backward tracing of products, salvaged product records, and food product examination and reprocessing records.


Privacy and Security Statement


Your responses to this survey will be kept strictly confidential. All data you provide is being collected and compiled by Eastern Research Group, Inc. (ERG), an independent consulting firm contracted by the U.S. Food and Drug Administration (FDA). ERG will provide FDA personnel only with a summary of the data compiled in the course of the study. In keeping with longstanding FDA practice, ERG will not provide FDA with identifiers that would permit the association of specific responses with a given respondent.


ERG has provided for the security of your Food Industry Practices Survey data, ensuring that your information is handled in the safest and most confidential manner. Our data security measures include the following.


Upon entering the Food Industry Practices Survey Web Site, you'll be asked to provide a log-in password. This password is provided for your exclusive use. A password is provided only to those facilities that have registered with the FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and supplied a valid email address.


Also, the information exchanged between your Web browser and ERG is encrypted for your protection. The encryption process converts the information being transmitted into uninterruptible machine code and then back into readable information once it is safely received.


The survey requires the use of Microsoft Internet Explorer 4.02 or higher or Netscape 4.08 or higher. These are two popular Web browsers that support the 128-bit encryption key used by the Food Industry Practices Survey Web Site to provide the security measures mentioned above. With over a trillion possible key combinations, it is the highest level of data encryption possible. Each time you sign in to the Food Industry Practices Survey Web Site, your computer is assigned a different key combination. Anyone who attempts to break that code would have to start over every time they entered the site.


Frequently Asked Questions

1. How will my data be kept secure if I submit my responses to the Food Industry Practices Survey via the Internet?

ERG has provided for the security of your survey data, ensuring that your information is handled in the safest and most confidential manner. ERG security measures include the following.

Upon entering the survey Web Site, you will be asked to provide a password. This password is provided for your exclusive use by ERG. A password is provided only to those companies scheduled to participate in the survey.

Also, the information exchanged between your Web browser and ERG is encrypted for your protection. The encryption process converts the information being transmitted into uninterruptible machine code and then back into readable information once it is safely received.

The ERG survey requires the use of Microsoft Internet Explorer 4.02 or higher or Netscape 4.08 or higher. These are two popular Web browsers that support the 128-bit encryption key used by the survey Web Site to provide the security measures mentioned above. With over a trillion possible key combinations, it's the highest level of data encryption possible. Each time you sign in to the survey Web Site, your computer is assigned a different key combination. Anyone who attempts to break that code would have to start over every time they entered the site.

2. I have forgotten my password. What should I do?

Contact the ERG survey helpline at surveyhelp@erg.com. Upon contact, we will send your password to the email address that you provide upon logging into the survey.

3. Can I make changes to the survey data that I submit?

Changes are permitted to any/all data submitted prior to the final submission of the survey. However, once you have reached the end of the survey and submitted the data, you cannot make any modifications.

4. What are the standards used for creation of the survey web pages?

The survey pages were designed in accordance with Section 508. Section 508 requires that Federal agencies' electronic and information technology is accessible to people with disabilities, including employees and members of the public.

In addition, the default screen size used in the creation of these pages is 800 x 600. This is the industry standard for normal default screen sizes used on 17-inch and higher monitor displays. You may adjust the viewing area of your monitor either by changing the text size settings of your browser or changing the screen size properties of your monitor.

5. What happens when I click on the “Next Page” button?

When you click on the “Next Page” button, all data entered will be automatically saved, and you will advance to the next page of survey. Please note that saving your data may take a few minutes, during which you will not be able to work further in the browser window.

6. What happens when I click on the “Previous Page’ button?

When you click on the “Previous Page” button, the previous page of the survey will be presented. Please note that all data entered on the page where you clicked the “Previous Page” button will be not automatically saved, unless you have clicked the “Next Page” button on that page previously.

7. What happens when I click on the “Submit Survey” button at the end of the survey?

When you click on the “Submit Survey” button, the entire contents of your survey are transmitted directly to ERG’s survey data collection database. Confirmation of your submission will then appear on your screen. Once you have submitted your survey, you will no longer be able to make changes to the data that you have entered online.

8. Who can I contact if I have questions about the survey?

You may send an email to surveyhelp@erg.com.


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File Typeapplication/msword
File TitleTraining
AuthorChet Fenton
Last Modified ByJonna Capezzuto
File Modified2007-05-22
File Created2007-05-22

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