Exercise Workbook - HACCP Mentor€¦ · Key learning from chapter and notes on your model food product : ... Notes for Exercises. 14 . FSPCA Exercise Workbook Version 1.2 . Chapter

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


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


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


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


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


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


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




Step





(3) Do any


hazards require a

preventive control?


column 3




preventive control

(6) Is the

preventive control


Yes No Yes No

Notes for Exercises




Step





(3) Do any


hazards require a

preventive control?


column 3




preventive control

(6) Is the

preventive control


Yes No Yes No

Notes for Exercises




Step





(3) Do any


hazards require a

preventive control?


column 3




preventive control

(6) Is the

preventive control


Yes No Yes No

Notes for Exercises




Step





(3) Do any


hazards require a

preventive control?


column 3




preventive control

(6) Is the

preventive control


Yes No Yes No

Notes for Exercises


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


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


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


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


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


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


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


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


Chapter 15: Recall Plan Discussion notes:

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Chapter 16: Regulation Overview Discussion notes:

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Documents

Exercise Workbook - HACCP Mentor€¦ · Key learning from chapter and notes on your model food product : ... Notes for Exercises. 14 . FSPCA Exercise Workbook Version 1.2 . Chapter