Homework for today was WORKBOOK EXERCISE: Expansion of the Universe (pg. 87-88 in workbook)
Exercise Workbook - HACCP Mentor€¦ · Key learning from chapter and notes on your model food...
Transcript of Exercise Workbook - HACCP Mentor€¦ · Key learning from chapter and notes on your model food...
Exercise Workbook Including Food Safety Plan Worksheets
Developed by the
FSPCA PREVENTIVE
CONTROLS FOR HUMAN FOOD
Notes for Exercises
This workbook was created to assist participants in the Food Safety Preventive Controls Alliance’s
Preventive Controls for Human Food course to practice exercises in an attempt to reinforce learning.
All exercises and examples are hypothetical. Application of preventive controls requires in‐depth
knowledge of actual operating conditions, thus information in the curriculum and in exercises may not
be directly applicable to a specific operation. Assistance from a preventive controls qualified individual
may be necessary to ensure compliance with FDA regulations.
1st Edition, Version 1.2, February 2016
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 1
Table of Contents Chapter 1: Course Introduction ...........................................................................................................2
Chapter 2: Food Safety Plan Overview .................................................................................................3
Chapter 3: GMPs and other Prerequisite Programs ...............................................................................3
Chapter 4: Biological Food Safety Hazards ............................................................................................4
Chapter 5: Chemical, Physical and Economically Motivated Food Safety Hazards....................................5
Chapter 6: Preliminary Steps in Developing a Food Safety Plan ..............................................................5
Chapter 7: Resources for Food Safety Plans ..........................................................................................6
Chapter 8: Hazard Analysis and Preventive Control Deteremination ......................................................7
Chapter 9: Process Preventive Control ............................................................................................... 12
Chapter 10: Food Allergen Preventive Control .................................................................................... 14
Chapter 11: Sanitation Preventive Control.......................................................................................... 17
Chapter 12: Supply-chain Preventive Control...................................................................................... 18
Chapter 13: Verification and Validation Procedures ............................................................................ 19
Chapter 14: Record-keeping Procedures ............................................................................................ 19
Chapter 15: Recall Plan ..................................................................................................................... 20
Chapter 16: Regulation Overview ...................................................................................................... 20
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 2
Chapter 1: Introduction to Course and Preventive Controls Read the definitions at the end of this chapter for “qualified individual” and “preventive controls qualified individual,” and review 21 CFR 117.180(a) and (c) in Appendix 1 about requirements applicable to a preventive controls qualified individual. Write down the tasks that…
You are comfortable performing _____________________________________________________
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You hope to learn to perform in this class _______________________________________________
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You will likely engage others to help you perform _________________________________________
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Discussion notes:
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Notes for Exercises
FSPCA Exercise Workbook Version 1.2 3
Chapter 2: Food Safety Plan Overview Discussion notes:
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Chapter 3: GMPs and Other Prerequisite Programs Write down key learnings from presentation and from GMP violations observed on slides
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Notes for Exercises
FSPCA Exercise Workbook Version 1.2 4
Chapter 4: Biological Food Safety Hazards Pick a food that you make or an ingredient that you use, then the information in this chapter and Appendix 4 – Foodborne Pathogen Supplementary Information to do the following:
Food or ingredient: _______________________________________________________________
Biological hazard associated with this food __________________________________________________
How might you prevent contamination? ____________________________________________________
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How might you kill the pathogen? _________________________________________________________
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How might you control growth of the pathogen? _____________________________________________
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Notes on other pathogens discussed:
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Notes for Exercises
FSPCA Exercise Workbook Version 1.2 5
Chapter 5: Chemical, Physical and Economically Motivated Food Safety Hazards Discussion notes:
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Chapter 6: Preliminary Steps in Developing a Food Safety Plan Key learning from chapter and notes on your model food product:
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Would you group or separate the products in the sample plan? Record your reasoning.
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Notes for Exercises
FSPCA Exercise Workbook Version 1.2 6
Chapter 7 Resources for Preparing Food Safety Plans Discussion notes and key references you may want to consider for the products that you make:
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Notes for Exercises
FSPCA Exercise Workbook Version 1.2 7
Chapter 8: Hazard Analysis and Preventive Control Determination PLANT NAME ISSUE DATE PAGE ADDRESS SUPERSEDES
PRODUCT CODE
Hazard Analysis for:
(1) Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled or
enhanced at this step B = biological,
C = chemical (including radiological) P = physical
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for
column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent
the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other
preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No B
C
P
B
C
P
B
C
P
B
C
P
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 8
Hazard Analysis for:
(1) Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled or
enhanced at this step B = biological,
C = chemical (including radiological) P = physical
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for
column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent
the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other
preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 9
Hazard Analysis for:
(1) Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled or
enhanced at this step B = biological,
C = chemical (including radiological) P = physical
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for
column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent
the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other
preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 10
Hazard Analysis for:
(1) Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled or
enhanced at this step B = biological,
C = chemical (including radiological) P = physical
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for
column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent
the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other
preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 11
Hazard Analysis for:
(1) Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled or
enhanced at this step B = biological,
C = chemical (including radiological) P = physical
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for
column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent
the food safety hazard? Process including CCPs, Allergen, Sanitation, Supply-chain, other
preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 12
Chapter 9: Process Preventive Control PLANT NAME ISSUE DATE PAGE ADDRESS SUPERSEDES PRODUCT CODE
Product Name:
Proc
ess
Pre
vent
ive
Cont
rols
Com
plet
e Gr
ay co
lum
ns a
fter V
erifi
catio
n an
d Re
cord
-kee
ping
Cha
pter
s
Reco
rds
Verif
icatio
n
Corr
ectiv
e Ac
tion
Mon
itorin
g
Who
Freq
uenc
y
How
Wha
t
Para
met
er,
valu
es o
r cr
itica
l lim
its
Haza
rd(s
)
Proc
ess
Cont
rol S
tep
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 13
Proc
ess
Pre
vent
ive
Cont
rols
(con
tinue
d) C
ompl
ete
Gray
colu
mns
afte
r Ver
ifica
tion
and
Reco
rd-k
eepi
ng C
hapt
ers
Re
cord
s
Ve
rifica
tion
Corr
ectiv
e Ac
tion
Mon
itorin
g
Who
Freq
uenc
y
How
Wha
t
Para
met
ers,
valu
es o
r cr
itica
l lim
its
Haza
rd(s
)
Proc
ess
Cont
rol S
tep
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 14
Chapter 10: Allergen Preventive Control What allergens are present in the facility?
Raw Material Name Supplier
Food Allergens in Ingredient Formulation
Allergens in Precautionary
Labeling Egg
Milk
Soy
Whe
at
Tree
Nut
(m
arke
t na
me)
Pean
ut
Fish
(m
arke
t na
me)
Sh
ellfi
sh
(mar
ket
nam
e)
Leav
e bl
ank f
or e
xerc
ise
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 15
Do all products contain the same allergens? If not, what do you do to control these allergens?
Product Name Production Line
Intentional Allergens
Egg
Milk
Soy
Whe
at
Tree
Nut
(m
arke
t na
me)
Pean
ut
Fish
(m
arke
t na
me)
Shel
lfish
(m
arke
t na
me)
What considerations did you take into account, e.g., scheduling and allergen cleaning?
Scheduling implications:
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Allergen Cleaning Implications:
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Are there allergen labeling implications?
Product Allergen Statement
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 16
Food
Alle
rgen
Pre
vent
ive
Cont
rols
Reco
rds
Verif
icatio
n
Corr
ectiv
e Ac
tion
Mon
itorin
g
Who
Freq
uenc
y
How
Wha
t
Crite
rion
Haza
rd(s
)
Alle
rgen
Co
ntro
l
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 17
Chapter 11: Sanitation Preventive Controls Based on the E.G. Food Company omelet example, determine whether the following is a GMP or a preventive control.
Activity GMP or Preventive Control
Notes
Assemble/wrap area is separate from the cook area
Employees wash their hands and don gloves
The assemble/wrap table is cleaned and sanitized with 200 ppm quat
Floors and walls in the assemble/wrap area are cleaned and sanitized
Floors and walls are sanitized in the refrigerator
For your model facility’s production areas requiring a sanitation preventive control, would you use dry cleaning, wet cleaning or both? Describe:
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For your model facility, is zoning appropriate? Is so, where would you apply it?
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Notes for Exercises
FSPCA Exercise Workbook Version 1.2 18
Chapter 12: Supply-chain Preventive Controls Identify at least one hazard requiring a supply-chain-applied control for your model food, then:
• Identify the control(s) to be applied by the supplier, • identify at least one supplier verification activity, • outline the elements the procedure would require, and • identify required records.
Raw material or other ingredient
Hazard requiring a supply-chain-applied control
Preventive controls applied by the supplier
Identification of supplier verification procedure(s)
Verification procedure
Records
Notes for Exercises
FSPCA Exercise Workbook Version 1.2 19
Chapter 13: Verification and Validation Procedures Add your activity results to the process preventive control form.
Discussion notes:
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Chapter 14: Record-keeping Procedures Add your activity results to the process preventive control form.
Discussion notes:
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Notes for Exercises
FSPCA Exercise Workbook Version 1.2 20
Chapter 15: Recall Plan Discussion notes:
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Chapter 16: Regulation Overview Discussion notes:
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