HACCP Application &

Implementation Training
Trainer: Muhamad Alexander Hamid Ho Bin Ridzuan
Date : 26.02.2024

1
WHAT IS HACCP?
A system which identifies, evaluates and controls hazards which are
Hazard significant for food safety (Codex
1999) 。
Analysi HACCP IS
s • Is a technique / process
• Is a systematic approach for the assurance of food safety.
Critical • Is internationally accepted as an effective system for production of safe
food.
• Can be applied throughout the food chain from primary production to
final consumption.
Control
FarmersManufacturer Service Industry
Point

2
RELEVANT STANDARD
✔ MALAYSIAN STANDARD : MS 1480 : 2019
FOOD SAFETY ACCORDING TO HAZARD
ANALYSIS AND CRITICAL CONTROL POINT
(HACCP) SYSTEM (SECOND REVISION)

✔ Codex Alimentarius:
HACCP System and Guidelines for its
application. (Annex to CAC/RCP 1-1969,
Rev 3 (1997)
3
ORIGIN & DEVELOPMENT OF HACCP
• Developed by Pillsbury Company in USA in 1959 for NASA
space programme.
• In the 1980’s – HACCP was used for food inspection
programmes
• By 1992 – system has been improved and its benefits
recognised worldwide.

4
 WHY DO WE BENEFITS OF
NEED HACCP ? HACCP
• It provides many benefits ⮚ Instils awareness in food safety.
• Legislation recommends it ⮚Sets a preventive system for
• Many customer require it as food safety assurance
one of the conditions of ⮚Increase confidence in
product safety
doing business
⮚ Reduces losses and wastage.
• It is a insurance against ⮚ Internationally recognized.
foodborne incidents and ⮚Meet requirements set by
disease. relevant regulatory authority.

5
 FOODBORNE INCIDENTS
Can be caused by : Can be caused by:
1) Biologicals Hazards 1) Supply of poor quality raw materials
e.g : microorganisms and their toxins 2) Mishandling of raw materials
3) Change of formulation of product
2) Chemical Hazards
4) Change in processing of product
e.g. cleaning agents, chemical residue
5) Cross contamination
3) Physical Hazards 6) Inadequate maintenance
e.g. foreign objects such s metal and glass 7) Addition of wrong ingredient.

THE VICTIMS
• Consumer safety
• Product quality
• Shelf life product
• Yield / recovery
• Recall
• Management time
• Credibility
• Reputation
• Market share
• Financially Stability
How do you prevent foodborne disease ?
►Quality raw materials
►Awareness of all staff
►Personal health ( communicable disease control)
►Proper temperature control
►Proper segregation of raw uncooked from ready-to-eat
food
►Proper handling
►Correct equipment cleaning and sanitation
►Waste control
►Pest control
7
HACCP PRINCIPLES
Principle 1 : Identify hazards and preventive
measures
Principle 2 : Identify Critical Control Points (CCP)
Principle 3 : Establish Critical Limit (CL)
Principle 4 : Establish CCP monitoring requirements
Principle 5 : Establish corrective actions
Principle 6 : Establish verification procedures
Principle 7 : Establish records 8
HACCP TERMS

Hazards Control measure

• Biological, chemical • Any action and / or
or physical agent in, activity taken to
prevent a significant
or condition of, food food safety hazard or
with the potential to reduce it to an
cause an adverse acceptable level.
health effect and/or
hypersensitivity.
9
HACCP TERMS

Correction Corrective Action

• Actions that must be • Any action and / or
taken if a critical activity taken to
prevent a significant
limit is exceeded at food safety hazard or
any step of food reduce it to an
production. acceptable level.

10
HACCP TERMS
Critical Control Point (CCP) Critical Limit (CL)
• Point, operational step • Measurable value which
or stage in the process separates acceptability
at which control can be from unacceptability.
applied and is essential
to prevent a significant
food safety hazard or
reduce it to an
acceptable level.
11
HACCP TERMS
Verification Validation
• Application of • Obtaining evidence that
methods, procedures, an element of the
HACCP plan is effective.
tests and other
evaluations, in
addition to
monitoring, to
determine
compliance with the
HACCP plan. 12
FOOD SAFETY HAZARDS

• Pathogeni • Mushrooms ,

Physica
• Plastic, glass

Chemica
Biologic

c Bacteria some fish

species or some • Metal, wood
• Virus tapioca species. • Bandages
• Toxins • Allergens • Jewellery
(Bacterial and

l
toxins and • Pesticides
al

other

l
mycotoxins • Sanitizers personnel
) items
• Lubricants
• Additives, • Insects
• Colorings… • Button
• Feathers, hair
• Rodent’s 13
Physical Hazards and Controls
Sources of Physical Hazards Prevention & Control

• Contaminated raw materials ❑ Applying Good Manufacturing Practices.

• Design of facilities ❑ Using appropriate ingredients &
and equipment supplies specifications.
• Faulty production procedure ❑ Obtaining letters of guarantee / certificate
• Improper employee practices of analysis from all supplies.
❑ Able to identify types of sources of
physical hazards
❑ Able to determine Critical Control Points
❑ Training employee in Good Hygiene Practices.

14
Chemical Hazards and Controls
Control Point Example Action / Procedure
Prior to receipt of raw materials, Raw materials assessment on
food ingredients and packaging specification before confirm
materials receipt.
Upon receipt of these materials Certificate of analysis verify
During processing Formulation control, Production
control, Cleaning and sanitation
control
During storage Segregate from raw materials
storage. Proper label / ID.
During the use of sanitizers, Training the handling employee
cleaning agents, lubricants.
Prior to the shipment of finished goods. Verify chemicals content
15
Biological Hazards and Controls
Pathogens :-
Common Pathogenic Able to cause sickness / disease through:
Bacteria Carried by Food
Aeromonas hydrophila Intoxication ( TOXIN) Infection ( INVASION)
Bacillus cerues • Staphylococcus : infected food • Salmonella : chicken
handler • Shigella :
Campylobacter • Bacillus : cooked rice fecal
jejuni Clostridium • C. perfringens : meat produce, contaminatio
botulinum soil n
• E. coli : minced beef, chocolate • Campylobacter : chicken
Clostridium
perfringens Shorter incubation period : 1- Longer incubation period :
2 hours 6- 72 hours
Escherichia coli
Where do pathogen come
Listeria •from
Low??quality raw materials
monocytogenes • Poor personal hygiene
Salmonella species • Inadequate cooking
• Improper storage / holding temperature
Shigella
• Improper reheating
dysenteriae • Cross –contamination – improper
Staphylococcus segregation
1
aurues Vibro • Past use-by-time 6
FACTORS AFFECTING MICROBIAL GROWTH
• FOOD / NUTRIENTS
• ACIDITY
• TEMPERATURE
• TIME
• OXYGEN
• MOISTURE
• PRESERVATIVES

17
1. TEMPERATURE
• Grow ideally at body temperature (37.5’C). • Hot temperature (above 70’C) will kill
• Also grow at temperature higher or lower most bacteria.
than this temperature.
• Fridge temperature will slow bacteria Bacillus
growth Escherichia coli,
sterothermophilus
Archea e.g.
Salmonella Pyrolobus

Pseudomonas
fluorescens

18
2. TIME
• At an ideal temperature, bacteria will double in number every 20
minutes.
Under ideal condition
O’clock Bacteria
12.00 1
12.20 2
12.40 4
1.00 8
2.00 64
3.00 512
4.00 4096
5.00 32768
6.00 262144
7.00 2098152
19
3. MOISTURE
• Bacteria must receive their food in some kind of water solution.
• This solution is described as water activity (A w), which is the
amount of water available for growth of bacteria.
Aw = 𝑣𝑎𝑝𝑜𝑟 𝑝𝑟𝑒𝑠𝑠𝑢𝑟𝑒 𝑜𝑓 𝑓𝑜𝑜𝑑 Food Water Activity
𝑣𝑎𝑝𝑜𝑟 𝑝𝑟𝑒𝑠𝑠𝑢𝑟𝑒 𝑜𝑓 𝑤𝑎𝑡𝑒𝑟 Water 1.00
• Aw of water = 1.00 Fresh fruit 0.91 – 1.00
Bread 0.90 – 0.99
Water Activity Limit for
Microbiological Cheese 0.95 – 1.00
Growth Fresh meat 0.95 – 1.00
Group Minimal Aw Value Jam 0.75 – 0.80
Most bacteria 0.91 Honey 0.54 – 0.75
Most yeast 0.88 Chocolate candy 0.55 – 0.80
Moulds 0.82 Milk powder 0.20
Biscuit 0.10 20
4. ACIDITY
• Acidity or alkalinity of food is measured by pH.
• Acidic foods – vinegar, pickles, fruits and vegetables.
• Neutral food : pure distilled water.
• Most microorganism like to grow in near neutral
condition. Microorganisms & pH
Microorganisms pH
Salmonella 6.0 – 7.5
Staphylococcus aurues 6.8 – 7.5
E.Coli 6.0 – 8.0
Most bacteria 5.5 – 8.0
Yeast ( spoilage organisms) 4.0 – 6.5
Moulds ( spoilage organisms) 4.5 – 6.8

21
5.
OXYGEN
Aerobic Bacteria Anaerobic bacteria
Need oxygen Does not need oxygen
Gram – negative roods, Gram- positive rods
cocci Gram – positive rods,
cocci
Most pathogenic bacteira Clostridium botulinum
6. PRESERVATIVES
Natural preservatives Chemical preservatives
Salt and sugar Sodium nitrite, benzoic acid
Function: Water –binding capacity Function: Inhibit microbial (bacteria,
yeast and mould) to grow.

22
HOWTO IMPLEMENT A
HACCP PLAN ?
1. Based on the application of 7 key
principles
2. Key elements :
• common sense;
• knowledge of product and process ;
• understanding of HACCP

23
 HACCP PLAN
HACCP Plan shall mean a document prepared in
accordance with the principles of HACCP to ensure
control of hazards which are significant for food safety in
the segment of the food chain under consideration

24
 Logic Sequence for Application of HACCP System
Get
Construct
Management Set
Commitment,
Assemble HACCP Identify Flow
Diagram On site
Food Safety Describe
Team Intended Confirmation
Policy and Scope Product
Use of Flow
of Objective
Diagram

P5: Determine P4: Determine a P3: Determine P1: Determine

P2:
corrective action monitoring critical limit hazards and
Determine
for deviations system for each for each CCP control measures
CCPs
CCP

P6:
P7: Review HACCP
Determine
Documentation & Plan
verification
records keeping
procedures
25
Prerequisites of HACCP System
Establishment
1) Management 2) Product
Responsibility Description

3) Intended use(s)
of product and 4) Process
potential flow
consumers’ abuse diagram

26
 1) Management
Responsibility
Management
Define and document Food Safety Policy
and Food Safety Objectives
Appoint HACCP coordinator / team leader

HACCP Coordinator / Team Leader

: Ensure HACCP system established, implement and
maintained.
: Report and improving the effectiveness and suitability.
: Organizing and coordinating work of HACCP team.

HACCP Team Member

: Identify and record problems with
products, processes and HACCP system
: Initiate correction, corrective action and control NC products
: Initiate action to prevent of occurrence and recurrence. 27
FOOD SAFETY POLICY: FOOD SAFETY OBJECTIVE:
✔ State with the organization's ✔ A realistic, objective and
formal commitment to food measurable goal within the
safety. It explains in general timeframe to support a food safety
how the management will policy that has been set.
implement the food safety
system. ✔ Use the SMART formula as a
guide to develop this Food Safety
✔ This policy will be a driving
force and will encourage the Objective.
organization to improve the
effectiveness of the food
security system.
28
HACCP Team member:-

❑Multidisciplinary to include representatives from Production, QA,

Engineering, Product Development, Store, Purchasing, Marketing and Sales.
❑ Personnel competency on performing work affecting food safety.
❑ Training plan
❑ Effectiveness of the training provided.
❑Ensure personnel responsible for monitoring, corrections and corrective
actions are trained.
❑ Communicate the importance of food safety to all personnel
❑ Maintain the records of education, training, skills and experiences.
❑ Training and retraining be reviewed at appropriate intervals.
29
2) Product description &
Product Description :
• Summary of food product manufactured
3) Intended use(s) of the product at factory
• Formulation . recipe
and
potential consumers’ abuse Method of Distribution:
• Frozen
Important elements: • Refrigerated
❖ Materials used (No. 4) • Shelf-stable
❖ Sensitive material identified
❖ Potential material known to cause Intended Use :
hypersensitivity identified • Describe food product for storage,
preparation, serving and handling.
❖ Rework material (N/A)
❖ Important product characteristics (No. 3)
Consumer:
❖ Process type (No. 2) • General public or a particular segment of
❖ Packaging and labelling (No. 6 and No. 10) population e.g. infants , the elderly.
❖Shelf-life and storage conditions (No. 5
and No. 7)
❖ Handling and distribution (No. 11) 30
4) Process flow diagram
Requirements:-
Provides schematic overview of Verifying Flow diagram
operation including: ✔ Verified for accuracy
a) Sequence of all steps for and completeness
manufacturing process ✔ Achieved by on-site
b) Where raw mat. and inspection of facility,
intermediate products join the equipment and
flow operations
✔ Must accurately reflect
c) Where reworking take place
the current processes
d) Where intermediate, by-products and operations
and waste are removed
e) CCPs
f) Critical limits at CCPs 31
Pre-requisite Programmes
• PRP (or GMP : Good
Manufacturing
Practices) shall be
implemented in
accordance with MS
1514 before HACCP
system is established.
32
 Validation
• Proofing • HACCP plan prior to • Regulatory
• Is it the right thing to its implementation requirement
do? • Control measures • Scientific data
• Is it STILL the • Critical limits and literature
right thing to do? • Corrective actions • Plant test data /
• Obtaining evidence • when there are results
that an element of the changes to the
HACCP plan is operation ( e.g.
effective. processes, raw
(MS1480:2019) materials, ingredients,
packaging, equipment,
etc.) that could
Wha Whe
adversely affect food
safety. How
t n 33
7 Principles of HACCP
system
1. Identification of hazards and determination of control
measures.
2. Determination of Critical Control Points (CCPs).
3. Determination of critical limits for each CCP.
4. Determination of monitoring system for each CCP.
5. Determination of corrective actions for each CCP.
6. Determination of verification procedures.
7. Documentation and record keeping.

All 7 principles shall be summarised in HACCP Plan. 34

 Principle 1:
Identify hazards & control measures
• Develop a list of hazards that are reasonably likely to cause injury or
illness.
• Identify appropriate control measure for each hazard ( biological ,
chemical and physical).
• Control measure : Any action, activity or device that can be used to
prevent, eliminate or reduce to an acceptable level.
• Hazards associated with each step must be listed along with any
control measure for them.
• When conducting a hazards analysis SAFETY concerns MUST
be differentiated from QUALITY concerns. 35
Hazard Identification
• Brainstorming session
• Review ingredients, process steps , storage/ distribution and use
• Develop a list of potential hazards which may be introduced,
increased or controlled at each step

Hazard Evaluation
• Determines which potential hazards must be addressed in HACCP plan.
• Based on the severity and likely occurrence of each hazards
• Severity - the seriousness' of the consequences of exposure to
the hazards
• Risk : The likely occurrence of the hazard based on experience,
technical literature, epidemiological data, etc. 36
Hazard Matrix Table (ECO-QA-
AP21) Likelihood Hazard Column
Severity Decision
Matrix Value Color
A B C D E
Essential control
1 1 2 4 7 11 1~6 Pink measure
Is a CCP
2 3 5 8 12 16
Advised control
3 6 9 13 17 20 7 ~ 10 Yellow
measure Is a OPRP
4 10 14 18 21 23
11 ~ 25 Green Practice GMP / PRP
5 15 19 22 24 25

(A) Severity (B) Likelihood

1. Can be fatal A. Common occurrence
2. Can cause serious illness B. Know to occur (it has happened at our
3. Can result in product recall premise)
4. Can generate a customer C. Could occur (I’ve heard of if happening)
complaint D. Not expected to occur
5. Insignificant E. Practically impossible 37
Example of Control Measure : EXAMPLES Preventive Measures:
•Biological Hazard
Time/temperature control ✔ Cleaning and sanitation Program
Product characteristics ✔ Pest Control Program
manipulation: water
activity, acidity (pH), oxygen ✔ Good Personal Hygiene
content, additives ✔ Supplier Quality Assurance
(preservatives)
• Chemical Hazard ✔ Temp Control for cooking
Formulation control and Refrigeration
Segregation from non-intended
chemicals ✔ Control and Maintenance of
• Physical Hazard Plant, Machinery and Its
Visual inspection before Surrounding
usage Filtering

38
 Principle 2 : Determination of CCPs
Critical Control Point :
A step at which control can be applied and is essential to
prevent, eliminate or reduce to an acceptable level a food
safety hazard.

⮚ Prevent a food safety hazards

Example : Modify a product formulation o reduce the pH below
4.6

⮚ Eliminate a food safety hazard

Example : Thermally process a product to destroy a
potential population of known pathogens.
39
RAW MATERIAL CCP DECISION TREE
Yes No
Is there a hazard with this
Q1
raw material? Go to Q2 Not a CCP

↓
Yes No
Are you or the consumer going to
Q2
process this hazard out of Sensitive raw
Go to Q3
product? material control is a
CCP
↓
Yes No
Is there a cross-contamination risk
Q3 to the facilities or to other products Sensitive raw material
which will not be controlled? Not CCP
control is a CCP

40
 PROCESS STEP CCP DECISION TREE
Yes No
Are there preventive measure(s) for the
Q1 Q1.1 Is control necessary Modify step, process
identified hazard? Go to Q2
at this step for safety? or product

↓ ↓
↓ No Yes
↓ Not a CCP ® Proceed*

No Yes
Is the step specifically designed to eliminate or
Q2 CCP
reduce Go to Q3
the likely occurrence of a hazard to an acceptance Need Control
level?
↓
Would contamination occur at unacceptable level(s) Yes No
Q3
or increase to unacceptable level? Go to Q4 Not a CCP ® Proceed*

↓
Yes No
Will a subsequent process step eliminate or reduce
Q4 CCP 41
the hazard to an acceptable level? Not a CCP ® Stop
Principle 3: Determination of Critical Limit
Critical Limit
• Is the tolerance range within the limit.
• If the critical limits are exceeded, the CCP is out of
control – potential hazard.
• Each CCP must have a CL in order to determinate the CCP
is
IN or OUT of control.
• A CCP may have one or more CL.
• A CL is used to distinguish between safe and unsafe
operations at critical CCP – it defines the “Boundaries of 42
Rule of thumb for Determination
Measurement
of Critical Limits for Each CCP : Particle size

Measurement
(P3) : Chemical
concentratio
n
Chemical Hazards:
Non-intended
Physical
chemical Hazards
CL Shall be: adulteration
:
✔ Specified for each
, intentionally
added chemicals
but added beyond
Foreign
acceptable limit, matter
CCP Food allergen

✔ Measurable Biological
Hazards:
✔ Scientifically Food
validated pathogens Measurement:
and virus Bacterial count
43
Establishing Operational Limit (OL)
OL:
• Criteria that are MORE STRINGENT than critical limit
(CL) and that are used by an operator to reduce the risk of a
deviation.
• When OL deviates, it only needs process adjustment (an
action taken by the firm to bring the process back within
operational limits.

44
 Principle 4:
Establish CCP Monitoring Program
Monitoring is defined as:
• Conducting a planned sequence of observations or measurements to
assess whether or not a CCP is under control and production an accurate
thereof for future use in The 5 keys of
record monitoring:
verification.
Monitoring procedure shall comprise the ❖ WHAT?
❖HOW?
following:- ❖WHERE?
a) What is being monitored ❖WHEN?
❖WHO?
b) Monitoring method
c) Monitoring frequency; and
d) Personnel responsible for monitoring and evaluating the monitoring
result. 45
 Principle 4:
Establish CCP Monitoring Program
Monitoring records:
- Data entered must be accurate and timely
- Free of error or omissions
- Free of whiteouts, erasures, blackouts, etc.

Monitoring record must be:-

- Reviewed, dated and signed or initialled by someone other than the
monitoring person ( i.e. verification).
- Reviewed prior to shipment of the products ( i.e pre-shipment review)
- Made available to audit personnel upon request
- Retained as required by regulations ( shelf life + 1 years).
46
Example of Monitoring System (P4)
Criteria Example (Ref: BRD HM09)
a) What is being monitored? Baking steps’ time and temperature
b) Monitoring method (devices used) Monitor and record Oven temperature

c) Monitoring frequency End of each baking step

* Frequency shall be able to identify any

nonconformity in time for product to be
controlled and isolated

d) Personnel(s) responsible for Monitored by: Baking Supervisor

monitoring and Verified by: Factory Manager
evaluating the monitoring result
e) Location of monitoring Baking Area

47
Principle 5: Establish Corrective Actions
Deviation :
- A failure to comply with a stated critical limit / operation
limit.
- Corrective actions must be developed for each CCP to
remedy an associated deviation and assure product safety.
- Corrective action “FIX” the deviation and assure
compliance with the HACCP plan is maintained.
- Purpose of corrective action:
❖Ensure CCP is brought back into control
❖Ensure products manufactured during CCP deviation
are handled according to procedure for NC products. 48
The HACCP plan shall describe the corrective actions to be taken
and assign the responsibility for taking each one.
❑Employees should be trained on the proper corrective actions to take
in response to deviations of the CCPs for which they are
responsible.
❑The first action that should be taken is to get control of / address
the affected product ( i.e place it on HOLD)
❑All corrective action must be thoroughly and accurately, recorded.

❑Corrective Action Records

- All CA shall be recorded
- Help processors summarise the problem that has occurred to
make HACCP plan effective.
- Record provide evidence of disposition. 49
 Principle 6:
Establish Verification Procedures
• The verification procedures is to determine whether
the HACCP system is implemented in accordance
with the HACCP plan and effectively.
• Verification
⮚all significant hazards and preventive measures have
been identified.
⮚ Critical limits are sufficient to guarantee safety
⮚ monitoring procedures are effective
⮚ Corrective actions are appropriate.
50
Verification
Activities
1. :-
Review of HACCP system and its corresponding records.
2. Analysis of (near) recalls and product dispositions.
3. Assessment of all control measures.
4. Compliance of the actual flow diagrams and layout with the
documented situation.
5. Analysis of customer and consumers complaints related to food
safety.
6. Review of analytical outcome of random sampling and
analysis of products.
7. Evaluation of conformity with applicable legislation and
regulations
8. Review of gaps between current and desired level of
knowledge, awareness and training of staff with respect to 51
Verification shall be carried out by means:-

Review Audits HACCP Plan

(IA /EI) Review
Records

Management Calibration
Review
(MR)
52
Internal Audit
• Have planned intervals (Yearly)
• Internal auditors are qualified personnel
• Establish an audit programme / procedure
• The audits is to determine the HACCP system conforms to
the planned arrangement and it is effectively implemented
and updated.
• BRD / P21 Internal Audit

53
Management Review Present in manner that
enables top management
(MR)
Not more than 12 months to relate the information
MR shall include at least to stated objectives of
:- food safety management
system
• Follow up actions from previous
MR
• Analysis of result of verification activities including
internal audits, external audits and inspections
• Changing circumstances that can affect food safety
• Emergency situations, accidents and recall
• Reviewing result of system-updating activities
• Review of communication activities, including customer
54
feedback and complaints
Management Review (MR)
The outcome fro MR shall include decisions and actions related
to:-
✔ Assurance of food safety
✔ Effectiveness of the HACCP system
✔ Resource needs ; and
✔ Revisions of the organisation’s food safety policy and
related objectives.

Maintain MR records.

55
 Principle 7 :
Documentation & Record
Records are kept for Active HACCP records include:
several Keeping
reasons:- ❖ Reason why CCPs were selected
❖ Reason why the critical limits have
• Evidence of product safety been selected.
• Regulatory compliance ❖ CCP monitoring records
• Tracing product ( traceability) ❖ CCP verification records
❖ Calibration records
• Review of procedures / ❖ Corrective action records
processes ❖ Overall HACCP plan
❖ Other records (example sample result)

HACCP plan should be included

as part of the plant’s records. 56
Records Maintained
On computer
Acceptable, provided appropriate
controls are implemented to
ensure the integrity of the
electronic data and signatures

57
 HACCP Document Control
• Maintain a list of controlled copies of the HACCP plan
• Any proposed amendments to the HACCP plan must go through
a planned sequence for approval (SOP)
• A system of auditing needs to be in place to ensure that all copies of
the HACCP plan are updated when any amendments are made.
• Amended pages of the HACCP plan must be indicated in some
manner.
• Establish a filling system for the HACCP plan associated records
and supporting materials
✔ Accessible to plant and External Auditor personnel
✔ Provide adequate security
58
Hazard Analysis Worksheet for RM

59
Hazard Analysis Worksheet for RM

60
Hazard Analysis Worksheet for PM

61
Hazard Analysis Worksheet for PM

62
Hazard Analysis Worksheet for process
step

63
Hazard Analysis Worksheet for process
step

64
HACCP Plan
Summary

65
 7 HACCP Principles can be summarized
in HACCP Plan Summary
BRD/ HM09

P2

P1

P3 P5 P6 P7

P4
66
 PROBLEMS FACED IN
IMPLEMNETING HACCP SYSTEM
• Lack of knowledge and understanding about
HACCP.
• Lack of skilled personnel to look after the
system.
• Lack of confidence in HACCP.
• Lack of resource.
• Lack of facilities.
• Lack of funds.
• Lack of inter and intra sectoral coordination.
67
Operation of HACCP System
N Operation of HACCP Remark Documented Procedure
o
1. Records relating to Records shall be maintained BRD P01 Control of
the HACCP system Documents &
BRD P02 Control of Records
2. Control of non- • NC product shall be labelled BRD P16 Control of Nonconforming
conforming • It may be reworked, segregated Product
product or disposed
3. Traceability • Enables to identification of product BRD P20 Product Withdrawal
lots and their relation to batches of & Recall
RM, processing and delivery records
• Able to identify in-coming material
from the immediate suppliers and the
initial distribution route of FG.
• Traceability records shall be maintained
• Important to ensure an effective
and efficient recall system

68
Operation of HACCP System
N Operation of HACCP Remark Documented Procedure
o
4. Notification and recall • Shall be given the degree of detail BRD P19 Handling of Customer
regarding traceability in production Complaint
and post-delivery
• Ensure rapid identification and
removal of products from the market
in a timely manner.
• Recall shall be evaluated to ensure
effectiveness.

5. Control of measuring • Shall assess the validity of the BRD P07 Preventive Maintenance &
equipment and previous measurement result when the Calibration
methods equipment process environment is
found not to conform to requirement.
• Take action on the process
environment and any affected
product.
65
• Validate the software system is used in
monitoring and measuring.
Maintaining the HACCP System
• Maintain effective HACCP system through regularly
scheduled verification activities.

• Implementation of HACCP system involves the

continual application of monitoring, record-keeping,
corrective action procedures and others activities.

• Maintenance of HACCP system communicate

through HACCP Team Meeting.
70
 REVIEW HACCP
PLAN
Scope
1. To review HACCP Plan.
2. To establish whether CCPs and CLs are
adequately controlled and monitored.
3. To determine if the procedures for product
deviations and record-keeping are being
followed correctly.
Objective
To evaluate the development of HACCP plan
To evaluate day-to-day compliance of HACCP
plan
Purpose
4. To ensure all hazards have been identified
5. To ensure that every hazard is being controlled
71
6. To provide consumer with a safe product.
 REVIEW HACCP PLAN
• Introduction of a new product or a change
in formulation to any existing product.
• Any change in a processing / production parameter
• Installation of any line equipment or modification
• Changes in packaging or final product handling
• New hazard awareness regarding potential pathogens
or environmental contaminants.

72
HACCP SYSTEM EVALAUTION
Potential hazards can be identified through:
▪ HACCP records, including flow diagram, deviations from
CLs and instrument calibration records.
▪ Product history including recall and market withdrawal information.
▪ Consumer / customer complaint trends
▪ Scientific literature articles
▪ Regulatory agency alerts
▪ Test result from sample monitoring

Go through the HACCP 7 principles during

73
evaluation
 INTERNAL VERIFICATION
By HACCP Team member
Key to successful evaluation and revision of a HACCP
system

Interaction of HACCP Team

Type of Internal Verification

1.Review of Records
2.HACCP Plan Revisions
3.Periodic Verification Procedures
• Spot checks or sample analyses
• Review of calibration records
74
 EXTERNAL VERIFICATION
By Regulatory Authority & 3rd party certification
body

Type of Auditing
1. Compliance
Audit Getting ready for auditing:-
• GMP requirement are met
a. Adequacy
audit • Sanitation procedures in-place
b. On-site audit • HACCP Manual
c. Follow-up must be established
audit • HACCP system must
2. Surveillance be implemented
Audit • Internal verification is done

75
Accreditation of Big Red
Dot
❖HACCP certification under surveillance of
Kiwacert
❖Validity: 3 years
❖Surveillance audit: at least once a year by
Kiwacert

Cakes Cookies Mooncakes Paste

76
 IMPORTANT
HACCP PLAN MUSTBE ON-GOING :
• In-place
• Up-dated
• Review on continuing suitability,
validation and effectiveness. 5 Important P’s
Premise
People
Process
Procedure(s
)
Product(s) 77
BRD CCPs
1. CCP 01a (Baking using OVN01 & OVN05)
2. CCP 01b (Baking using OVN03 & OVN04)
3. CCP 02 (Cooking)
4. CCP 03 (Metal Detecting)
5. CCP 04 (Packaging Sealing)
CCP 01a (Baking using OVN01 &
OVN05)
CCP 01a (Baking using OVN01 & OVN05)
– OL (Cakes and Cookies Baking Record)
CCP 01a (Baking using OVN01 & OVN05)
– OL (Mooncakes Baking Record)
CCP 01a (Baking using OVN01 & OVN05)
– CL (Baking Monitoring Record)
CCP 01b (Baking using OVN03 &
OVN04)
CCP 01b (Baking using OVN03 & OVN04)
– OL (Cakes & Cookies Baking Record)
CCP 01b (Baking using OVN03 & OVN04)
– CL (Baking Monitoring Record)
CCP 02 (Cooking)
CCP 02 (Cooking) – OL (Paste
Preparation and Cooking Record)
CCP 02 (Cooking) – CL (Paste
Preparation and Cooking Record)
CCP 03 (Metal Detecting)
CCP 03 (Metal Detecting) – CL (Packing QC
Inspection & Metal Detector Verification Record)
CCP 04 (Packaging Sealing)
CCP 04 (Packaging Sealing) – CL