UNIVERSITY KUALA LUMPUR MALAYSIAN INSTITUTE OF CHEMICAL AND

BIOENGINEERING TECHNOLOGY

STANDARD OF OPERATION (SOP)

SUBJECT:
HACCP
LECTURER’S NAME:
DR. NORIZA
PROGRAMME:
BACHELOR FOOD SAFETY AND QUALITY TECHNOLOGY
STUDENT NAME:
1) Nur Nadia Syazana bt Dzulkiple
2) Nor Adila binti Norhasmie
3) Siti Norzihan binti Hassan
4) Nur Izzati Husna Binti Nazmi
5) Amir Suhail bin Akmal Khir
6) Muhamad ArhamHaikal bin Md Hilmi
7) Mohammad Harris bin Shamsudin
8) 9. Nur Alifah Ilyana binti Roslee

STUDENT NO ID:
1) 55228121183
2) 55228121093
3) 55228121115
4) 55228121184
5) 55228121090
6) 55228121172
7) 55228121108
8) 55228121128
CLAUSE 6
Clause Requirement Document
6.1 Cleaning and sanitation SOP
6.1.1  SOP of Cleaning and
Sanitation
 SOP of Handling
Machines
 SOP of cleaning
equipment
 SOP of daily
monitoring and
sanitation inspection
CHECKLIST
 Pre-processing Factory
Hygiene Checklist
 Factory Hygiene
Checklist
FORM
 New Machine
Installation Form
SCHEDULE
 Cleaning and
Maintenance schedule
 Daily Cleaning and
sanitation schedule
6.1.2 Cleaning programmes: SOP
1. Areas, utensil and  SOP of Preparation
items of equipment Utensil
including food-contact  SOP of Cleaning and
surfaces, to be cleaned sanitation
2. Responsibilities for  SOP of Cleaning
particular tasks Utensils
3. Method and frequency  SOP of Cleaning
of cleaning Equipment
4. Monitory and  SOP of Hand washing
verification CHECKLIST
arrangement,  Pre-processing Factory
programmes should be Hygiene Checklist
 Factory Hygiene
Checklist
 Daily Area (Office,
Production, Toilet,
Kitchen, others)
 Cleaning Checklist
FORM
 Cleaning Materials
 Purchasing Form
 Receipt Of Purchasing

SCHEDULE
 Cleaning and
Maintenance Schedule
 Monitoring and
Verification Schedule
6.1.3 Protect against contamination SOP
of food  SOP of Prevention of
1. Food-contact surface Cross Contamination
2. Wet processing  SOP of Cleaning and
3. Non-food contact sanitation
surfaces  SOP of Cleaning
4. Single-services articles Utensils
5. Sanitising agents  SOP of Cleaning
Equipment
FORM
 Sanitising Agents
Purchasing Form
 Receipt Of Purchasing
SCHEDULE
 Cleaning and
Maintenance Schedule
 Monitoring and
Verification Schedule
6.1.4 Handling of cleaning and SOP
sanitising chemicals.  SOP of Handling
Chemicals
 SOP of Verification
and Record Keeping
CHECKLIST
 Personal Protective
Equipment Checklist
 Chemical Checklist
6.2.2 Corrective maintenance SOP
 SOP of Machines
Maintenance
SCHEDULE
 Cleaning and Maintenance
Schedule
 Monitoring and Verification
Schedule
6.2.3 Lubricant and heat transfer FORM
fluids  Product specification Form
CHECKLIST
 Personal Protective
Equipment Checklist
6.2.4 Releasing maintained SOP
equipment  SOP of Cleaning and
Sanitation
 SOP of Handling Machines
 SOP of Cleaning Equipment
6.2.5 Building, fixtures and other SOP
physical facilities  SOP of Cleaning and
Sanitation
 SOP of maintenance
operations
FORM
 Maintenance Operation
Form
CHECKLIST
 Packaging Materials
Checklist

6.2.6 Structural alteration, repairs, NIL

renovations, plumbing or
drainage
6.2.7 Maintenance, cleaning and SCHEDULE
sanitation programmes  Cleaning and Maintenance
a) monitored Schedule
b) periodically verified  Monitoring and Verification
c) regularly reviewed Schedule
6.3 Pest control systems SOP
6.3.1 Pest control programmes  SOP of Handling Chemicals
6.3.1.1 a) Responsible person  SOP of Pest Control
b) chemicals used Equipment
c) location SCHEDULE
d) method and frequency  Annually Pest Control
e) map of trap location Schedule
f) monitor the effectiveness  Monitoring and Verification
Schedule
EVIDENCE
 Certification of Pest Control
 (Company)
 Pest Control Layout
6.3.2 Pest control procedures SOP
6.3.2.1 Preventing access  SOP of Repairing
6.3.2.1.1 - Building should be kept in CHECKLIST
good repair and condition  Area Condition Checklist
6.3.2.1.2 Roll-up doors should close Evidence
tightly  Plant layout
6.3.2.2 Harbourage and infestation EVIDENCE
6.3.2.2.1  Pest Control Layout
6.3.2.3 Monitoring and detection NIL
6.3.2.3.1
6.3.2.3.2 Pest control programme SCHEDULE
(monitoring)  Annually Pest Control
Schedule
 Monitoring and Verification
6.3.2.4 Prevention SOP
6.3.2.4.1 Treatment with chemical,  SOP of Handling Chemicals
6.3.2.4.2 physical or biological agents  SOP of Pest Control
6.3.2.4.3 Equipment
CHECKLIST
 Chemicals Checklist
6.4 Waste management SOP
6.4.1 - Waste management  SOP of Waste Management
programmes
a) Responsibility SCHEDULE
b) location and condition  Waste Disposal Schedule
c) method and frequency of  Monitoring and Verification
disposal of waste Schedule
d) method and frequency of Evidence
cleaning of waste  Waste layout
e) monitoring and
verification

6.4.2 Solid waste management SOP

6.4.2.1 - Waste shall be disposed in  SOP of Waste Management
such manner as to prevent SCHEDULE
contamination  Waste Disposal Schedule
 Monitoring and Verification
Schedule
6.4.2.2 Location for removal and SOP
storage of waste  SOP of Waste Management
Evidence
 Waste layout
6.4.2.3 Waste bins and waste Evidence
 accumulating area  Waste layout
6.4.3 Liquid waste management SOP
6.4.3.1 -Liquid waste shall be  SOP of Waste Management
discharged in such a manner Evidence
as to exclude contamination  Waste layout
SCHEDULE
 Waste Disposal Schedule
 Monitoring and Verification
Schedule
6.4.3.2 Plumbing and effluent NIL
disposal lines, sewage
systems
6.4.3.3 Sumps or solid matter traps Evidence
included in the drainage  Waste layout
system
6.4.3.4 Liquid waste shall be treated SOP
and disposed in compliance  SOP of Waste Management
with the current regulations Evidence
 Waste layout
SCHEDULE
 Waste Disposal Schedule
Monitoring and Verification
Schedule

CLAUSE 7
CLAUSE REQUIREMENTS DOCUMENT PREPARE
7.1.1
People known or suspected
to be suffering from or to be
a carrier of a disease or
illness likely to be - SOP for food handling
transmitted through food, - To organize frequent medical
shall not be allowed to enter examinations
any food handling area if - Health declaration
there is a likelihood of their
food contamination. Any
7.1 person so affected shall
Personal Hygiene immediately report illness or
symptoms of illness to the
management

7.1.2
All food handlers shall be - Typhoid vaccine to be administered
vaccinated according to to all personnel food handling
current legislative - Medical Certification
requirements and medically
examined by a registered
medical practitioner

7.1.3
Food handlers should be - Health declaration form
excused for a specific time - Medical clearance form
until symptoms resolve or,
for some illness, after
getting medical clearance
before returning to work

7.2 7.2.1
Illness and Injuries Illness and injuries such as
jaundice, diarhea, vomiting, - Vaccination and medical
fever, persistent cough, sore examinations provided
throat with fever, and visibly - Minimal Change in Disease
infected skin lesions (boils, provided
cuts, etc) and discharges
from ear, eye, or nose shall
be reported to the
management so that any
need for medical
 examination and/or possible
exclusion from food
handling can be considered
7.2.2
Cut and wounds, where
personnel are permitted to - SOP for personal food hygiene
continue working, should be
covered by suitable
waterproof plasters and hand
gloves

7.3.1
All persons working in
direct contact with food,
food-contact surfaces, and
food-packaging materials
shall conform to hygienic
practices while on duty to
the extent necessary to
protect against
contamination of food. The
methods for maintaining
cleanliness include but are
not limited to:
a) wearing protective clothing,
light-colored and suitable to
the operations in a manner that
protects against the
contamination of food, food-
contact surfaces, or food
packaging materials
b) maintaining adequate
personal cleanliness such as
short and clean fingernails
c) providing understandable
signage directing employees to
wash their hands when
handling unprotected food,
unprotected food-packaging
materials, and food-contact
surfaces
d) washing hands thoroughly
(and sanitizing to protect
against contamination with
7.3 undesirable microorganisms)
Personal Cleanliness inadequate handwashing - SOP for Personal Food Hygiene
facilities before starting work, - SOP for Food Handling
after each absence from the - SOP to wearing the PPE
workstation, and at any other
time when the hands may have
 become soiled or
contamination
e) removing protective clothing
before visiting the toilet
f) removing personal effects
and other objects that might
fall into food, equipment, or
containers, and removing hand
jewellery that cannot be
adequately sanitized during
periods that can be maintained
in an intact, clean, and sanitary
condition, and which
effectively protects against the
contamination by these objects
of the food, food-contact
surface or food-packaging
materials
g) maintaining gloves, if they
are used in food handling, in an
intact, clean, sanitary
condition. The glove should be
of an impermeable material
h) wearing, where appropriate,
in an effective manner, head
covers, headbands, caps, beard
covers, face masks, face mask
extenders, or other effective
hair restraints
i) storing clothing or other
personal belongings in areas
other than where food is
exposed or where equipment or
utensils are washed
j) confining the following to
areas other than where food
may be exposed or where
equipment or utensils are
washed: eating food, chewing
gums, drinking beverages,
smoking, or vaping
k) taking other necessary
precautions to protect against
contamination of food, the
food contact surface, or food-
packaging materials with
microorganisms or foreign
substances including, but not
limited to, perspiration, hair,
cosmetics, tobacco, chemicals,
and medicines applied to the
skin
7.4 7.4.1
Personal Behaviour People engaged in food
 handling activities should
- SOP for food handling
refrain from any behaviour -SOP for personal food hygiene
could result in
contamination
- smoking
- vaping
- spitting
- chewing
- eating
- sneezing
- coughing
- licking any fingers
- scratching body
- blowing nose
7.4.2
Personal effects such as
jewellery, watches, pins, or
other items such as false - SOP for food handling
nails/eyes lashes that posed
a threat to the safety and
suitability of food shall not
be worn or brought into food
handling areas
7.5 Visitors to food
Control of Visitors - SOP for food handling
establishment, food - SOP for personal food
manufacturing, processing, hygiene
handling area should - SOP for form visitors who
- be instructed and comes into the manufacturing,
supervised processing, or handling areas
- wear PPE
- comply personal
hygiene provisions
- be guided through a
hygiene policy
CLAUSE 8
 CLAUSE REQUIREMENT SOP
8.1 -knowledge handle food
Awareness and responsibility safety
-awareness training
8.2 The type of control -allergen awareness
Management and supervision supervision needed will
depend on the size of the
food establishment, the
nature of its activities and
the type of food involved.
The GMP should been
knowledge and allergen
awareness to be able to
judge potentially of risks,
take appropriate corrective
and preventive action and
ensure effective
monitoring and
supervision take place.
8.3 8.3.1 The establishment - training plan document
Training Programmes shall prepare a training -training sessions
plan identifying the types - programme content
of training that are -competency of the trainer
essential for the -assessment of trainees
implementation and -establishment of the
maintenance of GMP. The requirement for retraining
need for training shall be - training and instruction
reviewed at appropriate programmes
intervals. -maintain the safety and
8.3.2 Training shall be suitability of food.
maintained at a level that -routinely reviewed and
ensures all employees updated Training
know their responsibilities programmes.
to maintain GMP. Details
of training sessions shall
include, for example,
programme content,
competency of the trainer,
assessment of trainees and
establishment of the
requirement for retraining.
8.3.3 Periodic assessments
on the effectiveness of
training and instruction
programmes
should be made, as well as
routine supervision and
checks to ensure that the
training is being carried
out

CLAUSE 9
Clause Requirements Documentation
9.1 Lot and batch SOP - SOP for product recall
9.1.1 identification Checklist- Product traceability
-Essential in traceability Raw material Checklist
and product recall.
9.1.2 - Provide a food
traceability system in
food premises to enable
the recall of the products.
9.2 Products information
and labelling
9.2.1 - All product should be
adequate information to
enable the next food
manufacturer in the
food chain or the
customer to handle,
prepare, display, store,
and/or use the product
safely and correctly.
9.2.2 Product labelling
- Product labelling
- Prepackaged should
be labelled with clear
instruction and include
information that
identifies food allergens
in the product as
ingredients or where
cross-contact cannot be
excluded.
9.3 Traceability
9.3.1 - Apply a traceability
system to identification of
product to batches of raw
materials p, processing
and delivery records.
9.3.2 - Be able to identify
incoming material from
immediate suppliers and
initial distribution route of
SOP - Sop for food traceability
Sop for product traceability
Checklist -Record keeping &link
management
-Process flow
-Data capture methods
-Suppliers vehicle checklist
FORM- Product traceability
-Rejection form
-Rejected incoming materials
-Despatch transport checklist
SOP- SOP for document control
Checklist-Warehouse Checklist (raw
materials)
-Traceability product
-Raw material Checklist
SOP-SOP for product labelling
--SOP for identification label and
status
-SOP for allergen food product
Checklist -Filtration Checklist
-Prepacked food Checklist
-Allergen management and
training
SOP-SOP for product lots
-SOP for raw materials batches
-SOP for traceability system
-SOP for traceability product
Checklist-Warehouse Checklist
-Despatch transport Checklist
-Suppliers vehicle Checklist
-Warehouse Checklist (finished
product)
-Product traceability
 the end product. FORM -Rejection form
9.3.3 - To ensure an effective -Rejected incoming material
and efficient recall
system.

9.4 Recall procedures

9.4.1 - Ensure effective SOP -SOP for formulation products
procedures are in place to -SOP for process validation
deal with any food safety Checklist -Product traceability
hazard and to enable the -Rejection form
effective recall of any -Rejection incoming materials
implicated the finished
food from the market.

9.4.2 -Recall system shall

include written
procedures to ensure
rapid identification and
timely removal from
the market of products
that may pose a hazard
9.4.3 to public health

- Other products with are

produced under similar
conditions and may
present similar hazard to
public health should be
evaluated for safety and
9.4.4 may need to be recalled.

- Should be held under

supervision and
determined to be safe
9.4.5 for human consumption
in a manner to ensure
their safety

-Should be documented
and maintained and
modified based on
findings of periodic
mock recalls.
CLAUSE 10
CLAUSE SOP FORM AND CHECKLIST

10.1 10.1.1 Food must be - Standard Operating

Design and requirement transported with
Procedures (SOPs)
adequate protection.
The nature of the food - Validation Documentation
and the conditions
- Design Documentation
under which it must be
transported determine - Equipment Qualification
the type of
Documentation
conveyances or
containers necessary. - Batch Records

10.1.2 Transport - Training Documentation

vehicles and bulk - Regulatory Documentation
containers must be
designed and
constructed to:

a) Avoid
contaminating food
and packaging.

b) can be cleaned and,

if necessary,
disinfected effectively.

c) allow effective
separation of different
foods or foods from
non-food items during
transport, as required.

d) protect against pest

infestation and other
forms of
contamination, such as
dust and fumes.

e) can effectively
maintain the
temperature, humidity,
atmosphere, and other
conditions required to
protect food from
harmful or undesirable
microbial growth, toxin
production, and
deterioration likely to
 render food unfit for
consumption; and

f) Permit any necessary

checks of temperature,
humidity, and other
environmental
conditions.
10.2 10.2.1 Food- - Standard Operating
Use and maintenance transporting
Procedures (SOPs)
conveyances and
containers must be - Batch Records
maintained in a
- Equipment Maintenance
suitable state of
cleanliness, repair, and Records
condition. When the
- Calibration Records
same vehicle or
container is used to - Change Control Records
transport different
- Training Records
foods or non-foods,
thorough cleaning and,
if necessary,
disinfection must occur
between loads.

10.2.2 Where
applicable, especially
in bulk transport,
containers and
conveyances should be
designated and marked
for food use only and
used exclusively for
that purpose.

CLAUSE 11
Clause Requirement SOP
11.1 Periodically, - Self-Inspection Checklist
Self-inspection designated personnel
- Standard Operating Procedures
shall conduct self-
inspections of all plant (SOPs)
facilities and
- Training Records
processing lines to
ensure the adequacy - Cleaning and Maintenance
and effectiveness of
Records
the GMP programme.
 11.2 11.2.1 Internal audit - Standard Operating Procedures
Internal Audit must be organised and
(SOPs)
carried out at least
once a year by - Validation Records
management-
- Calibration Records
designated
independent - Complaint Records
personnel. Auditors
are not permitted to
audit their own job.

11.2.2 Audits should

be expanded to
suppliers and
contractors as well.

11.2.3 Any
nonconformances
discovered must be
corrected as soon as
possible and closed
out once satisfactory
action has been done.

11.2.4 If internal
auditors are not
available within the
company, qualified
external sources can
be consulted.

CLAUSE 12
Clause Requirement SOP
12 Evaluate the ongoing - Minutes of meeting
Management Review suitability and
- Corrective and preventive
effectiveness of the
GMP to meet the actions
requirements of
- Audit reports
customers and
authorities as well as - Quality manual and procedures
the company's GMP
requirements.
CLAUSE 13
Clause Requirement SOP
13.1 13.1.1 Document - Document Control Procedure
Control of documents required by GMP shall
- Document Identification
be controlled.
- Document Review
13.1.2 Document
procedure shall be - Document Retrieval
established to define the - Document Revision Control
control.
- approve - Document Retention

documents for
adequacy the
issue.
- evaluate, revise,
and re-approve
papers as
appropriate.
- ensure that
changes and the
current revision
status of
documents are
identified.
- make certain
that current
copies of
pertinent papers
are accessible at
the points of
usage.
- make ensuring
that documents
are still readable
and
recognizable.
- manage the
circulation of
pertinent
documents with
foreign origin
and make sure
they are
recognized.
- To stop outdated
documents from
being used
unintentionally
and to make
sure they are
appropriately
labelled as such
if they are kept
for any reason.
13.2 13.2.1 - Record Control Forms
Control of records - Records must be
- Record Retention Schedule
legible, readily - Audit Trails
identifiable, and - Change Control
retrievable. Documentation
- Corrective and Preventive
13.2.2
- Records of processing, Action
manufacture, and
distribution must be
preserved for a specific
amount of time beyond
the product's shelf life.

13.2.3
- Records shall be in
accordance with
statutory and regulatory
requirements and
customer requirements
and can be based on the
product lot
identification