April 10, 2007 ERG
Please enter your pre-assigned survey password below.
If you have any questions about your participation, please contact the survey helpline at [email protected].
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
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.
Please answer each question as it pertains to your facility.
If you do not know the answer to a particular question, please consult with other members of your organization.
Throughout the survey, we use various words and phrases to have particular meanings. These are underlined. Please click on these to see a definition.
You need to provide a response to those questions marked with an asterisk (*) to be able proceed to the next applicable question.
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.
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 [email protected].
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:
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20 or fewer |
21 to 100 |
101 to 500 |
501 to 750 |
751 to 1,000 |
1,001 or more |
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Peak season? |
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Off season? |
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Q59. What percent of your total employees are part-time or temporary during:
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0% |
5% or less |
>5% to 10% |
>10% to 25% |
>25% to 50% |
>50% to 75% |
>75% |
a. |
Peak season? |
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b. |
Off season? |
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Q60. Approximately, how many production line managers/supervisors do you employ during:
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5 or fewer |
6 to 10 |
11 to 30 |
31 to 50 |
51 or more |
a. |
Peak season? |
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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?
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Not applicable |
Yes |
No |
a. |
Principles of food safety hazards and prevention |
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b. |
Personal hygiene practices |
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c. |
Basic cleaning and sanitizing |
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d. |
Allergen control |
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e. |
Other GMP practices ____________[verbatim] |
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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?
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None |
4 hours or less |
>4 to 8 hours |
>8 to 16 hours |
>16 to 48 hours |
>48 hours |
a. |
Food production operation managers |
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b. |
Production supervisors |
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c. |
Quality control managers |
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d. |
Sanitation and cleaning supervisors |
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Q82.(*) Approximately, how many hours of continuing training in food safety and sanitation do the following types of personnel receive annually?
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None |
4 hours or less |
>4 to 8 hours |
>8 to 16 hours |
>16 to 48 hours |
>48 hours |
a. |
Food production operation managers |
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b. |
Production supervisors |
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c. |
Quality control managers |
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d. |
Sanitation and cleaning supervisors |
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[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?
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Yes, for all employees |
Yes, for all except hourly employees |
Yes, for only hourly employees |
No |
a. |
Documentation of administered training |
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b. |
Documentation of the training content |
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c. |
Proof of management oversight |
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Corrective actions |
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e. |
Other _________________[verbatim] |
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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?
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Yes |
No |
a. |
Descriptions of specific steps for cleaning |
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b. |
Frequency of cleaning |
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c. |
Chemicals and cleaners to be used |
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d. |
Descriptions for disassembling and reassembling equipment |
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e. |
Personnel responsibilities for cleaning equipment |
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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?
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Yes |
No |
a. |
Descriptions of specific steps for sanitizing |
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b. |
Frequency of sanitizing |
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c. |
Chemicals and sanitizers to be used |
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d. |
Descriptions for disassembling and reassembling equipment |
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e. |
Personnel responsibilities for sanitizing equipment |
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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?
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Not applicable |
Regular inspections required |
Inspections conducted on an as needed basis |
Inspections not required |
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Flying insects |
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Food storage insects |
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Birds |
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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:
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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? |
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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? |
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[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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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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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?
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Not applicable |
Each batch is tested |
Statistical batch sampling |
Other |
Don’t know |
a. |
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b. |
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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?
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Yes, some |
Yes, all |
No |
a. |
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b. |
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Q194. Do you regularly maintain the following types of equipment and utensils records?
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Yes, some |
Yes, all |
No |
a. |
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b. |
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Q195. Do you regularly maintain the following types of materials records?
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Yes, some |
Yes, all |
No |
a. |
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b. |
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Q196. Do you regularly maintain the following types of personnel records?
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Yes, some |
Yes, all |
No |
a. |
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b. |
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Q197. Do you regularly maintain the following types of production and process controls records?
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Yes, some |
Yes, all |
No |
a. |
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b. |
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c. |
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Q198. Do you regularly maintain the following types of QA/QC and laboratory operations records?
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Yes, some |
Yes, all |
No |
a. |
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b. |
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c. |
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Q199. Do you regularly maintain the following types of validation records?
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Yes, some |
Yes, all |
No |
a. |
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b. |
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c. |
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Q200. Do you regularly maintain the following warehousing and distribution records?
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Yes, some |
Yes, all |
No |
a. |
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b. |
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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 |
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b. |
Permanent packing line employees |
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c. |
Seasonal employees |
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[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?
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Yes |
No |
a. |
Microbial contamination prevention |
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b. |
Reporting illnesses and injuries to supervisors |
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c. |
Use of toilet facilities |
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d. |
Proper hand washing |
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e. |
Personal cleanliness and hygiene |
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f. |
Facility cleaning |
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g. |
Equipment cleaning |
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h. |
Equipment sanitizing |
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i. |
Product handling |
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j. |
Other practices _________________[verbatim] |
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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 |
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b. |
Permanent packing line employees |
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c. |
Seasonal employees |
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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?
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a. Permanent supervisors |
b. Permanent packing line employees |
c. Seasonal employees |
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Yes |
No |
Yes |
No |
Yes |
No |
a. |
Documentation of administered training |
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b. |
Documentation of the training content |
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c. |
Proof of management oversight |
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d. |
Corrective actions |
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e. |
Other _________________[verbatim] |
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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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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 |
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Fecal coliform bacteria |
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Generic E. coli |
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E. coli O157:H7 |
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Salmonella spp. |
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Cryptosporidium parvum |
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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?
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Not applicable |
Never |
Weekly |
Daily |
Hourly |
Continuously |
a. |
Total chlorine |
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b. |
Free chlorine |
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c. |
Oxidation reduction potential (ORP) |
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d. |
PH |
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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.
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Automatic |
Manual |
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Disinfectant concentration monitoring |
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b. |
pH monitoring |
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c. |
Addition of disinfectant to water |
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d. |
pH adjustment |
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Q247. Please indicate whether you maintain a log or other records for the following?
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Not applicable |
Yes |
No |
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Wash water disinfectant concentration |
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b. |
Wash water oxidation reduction potential (ORP) |
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c. |
Wash water pH |
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d. |
Wash water temperature |
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e. |
Cooling water disinfectant concentration |
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Cooling water oxidation reduction potential (ORP) |
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g. |
Cooling water pH |
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h. |
Cooling water temperature |
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Q248. Do you keep the following records about your incoming materials?
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No |
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Field |
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Harvest date |
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Type of produce |
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Volume of produce |
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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]
[“Previous Page” and “Next Page” buttons]
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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-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
-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.
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.
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 [email protected]. 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 [email protected].
| File Type | application/msword |
| File Title | Training |
| Author | Chet Fenton |
| Last Modified By | Jonna Capezzuto |
| File Modified | 2007-05-22 |
| File Created | 2007-05-22 |