QUALITY MANUAL

HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 1 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
1.1 RECEIVING OF Poor suppliers GMP
PACKAGING Physical Presence of foreign Inspection
MATERIAL material, Torn Bag upon receipt
Mishandling during B 3 S Y N Y Y CP
(wood, plastic, metal, pest)
transport
Poor sanitation from
Biological- Dirty Packaging Suppliers end
GMP and SSOP - - - - -
(bacteria from pests) B 4 N/S
Dirty trucks
Chemical - Adhesive not food
Not aware of the Packaging
grade C 4 N/S - - - - -
standard specification
1.2 STORAGE OF Goods are stored off the
PACKAGING Physical inclusion of foreign floor, inappropriate
MATERIALS GMP and SSOP
materials shelving, on pallets or in B 3 S Y N Y Y CP
improper containers.
Goods are stored off the
Biological- Dirty storage
floor, inappropriate
rooms GMP and SSOP - - - - -
shelving, on pallets or in B 4 N/S
improper containers.

Chemical contamination Improper storage of

C 4 N/S GMP and SSOP - - - - -
from cleaning chemicals chemicals

2.1 RECEIVING OF Inspection

Torn packaging;
INGREDIENTS Physical: Contamination with upon receipt
inclusion of foreign B 3 S
foreign material In line metal Y N Y Y CP
material
detector
Torn packaging may
Biological: Contamination Product
serve as entry of insects B 3 S
from insects or pests specification Y N Y Y CP
or pests
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 2 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
-Checking of
Certificate of
Analysis every
delivery.
Chemical excessive toxic Improper storage of -Checking of
chemicals chemicals on the B 1 S expiration
Y N Y Y CP
-Allergens delivery trucks dates of each
batch received.
-Declaration of
allergens on
the label
2.2 STORAGE OF Goods are stored off the
INGREDIENTS Physical inclusion of foreign floor, inappropriate GMP and
C 3 N/S - - - - -
materials shelving, on pallets or in SSOP
improper containers.
Goods are stored off the
Biological- Dirty storage
floor, inappropriate GMP and
rooms C 3 N/S - - - - -
shelving, on pallets or in SSOP
improper containers.
Chemical contamination Improper storage of GMP and
C 3 N/S - - - - -
from cleaning chemicals chemicals SSOP
3.1 RECEIVING OF Physical Presence of foreign Poor suppliers GMP Inspection
STICKERS material, Torn Bag Mishandling during upon receipt
(wood, plastic, metal, pest) transport B 3 S In line metal Y N Y Y CP
detector
Biological- Dirty Packaging Poor sanitation from GMP and
(dust) Suppliers end SSOP - - - - -
B 4 N/S
Dirty trucks
Chemical - Adhesive not food Not aware of the Packaging
grade standard C 4 N/S specification - - - - -

3.2 STORAGE OF Physical inclusion of foreign Goods are stored off the GMP and
STICKERS materials floor, inappropriate SSOP
shelving, on pallets or in B 3 S Y N Y Y CP
improper containers.
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 3 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
Biological- Dirty storage goods are stored off the GMP and
rooms floor, inappropriate SSOP
- - - - -
shelving, on pallets or in B 4 N/S
improper containers.
Chemical contamination from Improper storage of GMP and
C 4 N/S - - - - -
cleaning chemicals chemical s SSOP
3.3 PRINTING OF Physical: N/A - - - - - - - - - -
STICKERS Biological: N/A
- - - - - - - - - -
Chemical : N/A - - - - - - - - - -
4.1 TRANSFERRING
TO PRODUCTION Physical: N/A - - - - - - - - - -
AREA Biological: N/A
- - - - - - - - - -

Chemical : N/A - - - - - - - - - -
5.1 PREPARATION OF Physical: N/A - - - - - - - - - -
RAW MATERIAL

(EGG Biological: N/A

- - - - - - - - - -
SANITATION,
SIEVING,
WEIGHING)
Chemical : N/A - - - - - - - - - -
5.2 EGG SANITATION

Mishandling during
Visual
Physical: Cracked egg shells storage and room C 5 N/S - - - - -
inspection
transfers

Due to open waste

Sanitation of
Biological: Pathogen containers
B 3 S eggs with Y N Y Y CP
contamination
500ppm
Cracked Egg shells
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 4 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
Improper preparation/
Chemical: high Cl concentration of
C 3 N/S MSDS and SSOP - - - - -
concentration cleaning solutions.
Inadequate rinsing
5.3 SIEVING Incorrect mesh size on
Use of correct
Physical: Contamination with the machine
B 3 S mesh size and Y Y - - CCP1
foreign material
sieving logs
Damaged screens
Biological: Recontamination Due improper cleaning MSDS and
C 3 N/S - - - - -
of microbes of machine SSOP

Chemical : N/A - - - - - - - - - -

5.4 WEIGHING Tools are made

from approved
materials that
Possible chipping of food
can with wear
contact surfaces, or
and tear during
Physical: contamination from inclusion of loose items
D 4 N/S use - - - - -
extraneous material and of pieces of
Checking of
packaging that adhered
loose items and
on the raw material
condition of
tool (pre-
operative)
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 5 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
Biological: growth of
pathogens
Under processing due to
overfill of containers
Pathogen contamination due
to improper employee
handling /
operating procedures Recontamination by GMP and SSOP
/equipment pathogens in product room
C 3 N/S Y N Y Y CP
Insufficient amount of accumulations, increase temperature is
additive (e.g.: nitrite) in product temperature controlled
Pathogen growth due to
time/temperature abuse
Product heavier than
maximum fill weight in
schedules process could
result in under-processing

Chemical - Contamination Not food grade

from Cleaning agents/ lubricants
Lubricants
Improper preparation/ MSDS, GMP and
concentration of C 3 N/S SSOP - - - - -
cleaning solutions.
Inadequate rinsing

6.1 TRANSFER TO Physical: N/A - - - - - - - - - -

PRODUCTION Biological: N/A
- - - - - - - - - -
Chemical : N/A - - - - - - - - - -
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 6 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
7.1 MIXING Physical: Possible chipping of food Monitoring of
Presence of extraneous contact surfaces, or loose items and
materials inclusion of loose items condition of
Contamination by metallic and of pieces of tool (pre-
and non-metallic fragments . packaging that adhered B 3 S operative) Y N Y Y CP
Metallic and non-metallic on the raw material
fragments from the
equipment can contaminate
the product.
Biological: Pathogen Poor sanitation of GMP and SSOP
contamination due to equipment Time and
improper handling and temperature
operation Time and temperature monitoring
C 3 N/S - - - - -
procedure abuse
Microbial development due
to improper temperature Mishandling on the part
control of the workers
Chemical : Chemical residues Not food grade
on product contact surfaces lubricants
due to improper
cleaning procedures Improper preparation/ MSDS, GMP and
C 3 N/S - - - - -
Cross contamination due to concentration of SSOP
allergens product cleaning solutions.
Inadequate rinsing
-
7.2 MOULDING Physical: Contamination by Possible chipping of food Monitoring of
metallic and non-metallic contact surfaces, or loose items and
fragments. Metallic and non- inclusion of loose items condition of
metallic fragments from the and of pieces of D 3 N/S tool (pre- - - - - -
equipment can contaminate packaging that adhered operative)
the product. on the raw material

Biological: growth of Poor sanitation of GMP and SSOP

pathogens, possible equipment
contamination from food C 4 N/S - - - - -
handlers Time and temperature
abuse
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 7 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
Chemical: incorporation of Not food grade MSDS, GMP and
cleaning chemicals lubricants SSOP

Improper preparation/
D 4 N/S - - - - -
concentration of
cleaning solutions.
Inadequate rinsing

7.3 BAKING Physical: air-borne pest, dust due to fragments falling

onto/into GMP and SSOP
D 3 N/S - - - - -
uncovered product

Biological: bacterial growth Due to inadequate Monitoring

control over time, of time,
B 2 S Y Y - - CCP2
temperature and temperature
humidity and humidity
Chemical - Improper preparation/
Contamination by non food concentration of
MSDS, GMP and
chemicals (e.g.: cleaners, cleaning solutions. D 3 N/S - - - - -
SSOP
sanitizers and Inadequate rinsing.
lubricants
7.5 COOLING Physical: air-borne pest, dust Poor pest control, Pest control/
GMP and SSOP C 3 N/S monitoring - - - - -
GMP and SSOP
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 8 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
Biological: Pathogen
contamination due to air-
borne pathogens (e.g.:
Listeria
monocytogenes)
Pathogen contamination due
to improper cleaning of
Pest control/
filters/inappropriate use of Poor pest control,
C 3 N/S monitoring - - - - -
filters GMP and SSOP -
GMP and SSOP
Pathogen contamination from
unclean environmental air
sources
Pathogen contamination from
dirty air blowing equipment
and cooling
units
Chemical : Contamination by
Improper preparation/
non-food chemicals (e.g.:
concentration of
cleaners, sanitizers, MSDS, GMP and
cleaning solutions. D 3 N/S - - - - -
lubricant) SSOP
Inadequate rinsing.
Contamination due to
excessive chlorine
7.6 PACKING Physical: introduction of Incorporation of loose Loose item log
foreign materials items, human C 4 N/ S sheet - - - - -
contaminants GMP
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 9 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
Biological: growth of Time and temperature Finished
pathogens abuse product
exposure time
Dirty packaging to ambient
temperature
must be
C 2 S controlled. Y Y - - CCP3
Time at the
start and end
of the process
to be
monitored for
each batch.
Chemical: Contamination of Contamination from Use only FDA
toxic substance deleterious chemicals approved
present in the packaging C 3 N/S packaging
materials materials.

7.7 STORAGE OF Physical inclusion of foreign Goods are stored off the GMP and SSOP
FINISHED materials floor, inappropriate
- - - - -
PRODUCT shelving, on pallets or in C 3 N/S
improper containers.
Biological- Dirty storage area Goods are stored off the GMP and SSOP
floor, inappropriate
shelving, on pallets or in
improper containers.
- - - - -
B 4 N/S

Chemical contamination Improper storage of MSDS, GMP

from cleaning chemicals C 4 N/S and SSOP - - - - -
chemicals
 QUALITY MANUAL
HACCP PLAN
CCP Determination - Scones
Document Code: Revision: 00 Effective Date: Page 10 of 10
PEGI-HCP-HAZ-02 September 2, 2016

Control Q Q Q Q CCP
Step / Input Hazard Cause Likelihood Severity S
Measures 1 2 3 4 CP
7.8 DISPATCHING Physical: contamination from Poor sanitation of Check the
extraneous material delivery trucks sanitation of
introduced from driver, helper, - - - - -
D 4 N/S
dirty trucks and van
condition.
Biological : growth of Time and temperature Product will
pathogen abuse not be loaded
into transport
vehicles if the
vehicles'
C 3 N/S - - - - -
temperature
does not
preclude
microbial
growth
Chemical: contamination Improper storage of Check the van
from cleaning materials, cleaning chemicals condition, and
D 4 N/S - - - - -
gasoline, oil etc contents before
loading