QUALITY ASSURANCE IN A

FOOD MANUFACTURING PLANT

BY: DUY NGUYEN LONG, MSC, MBA, 18/OCT/2021 – CHAPTER 4
 NỘI DUNG MÔN HỌC
CHƯƠNG 1
• Giới thiệu QLCL trongnhà máy hóa thực phẩm
• Thông tin cơ bản về hóa thực phẩm
• Vai trò của chất lượng trong nhà máy hóa thực phẩm
• Các mô hình QLCL hiện nay
• Xu hướng phát triển và định hướng nghề nghiệp
CHƯƠNG 2
• Khái niệm về an toàn thực phẩm
• Nhận diện các mối nguy trong ngành thực phẩm và
phòng tránh
• Khái niệm nhiễm chéo. Các yếu tố ảnh hưởng và biện
pháp ngăn chặn
• Các quy định pháp luật đi kèm
CHƯƠNG 3
• Khái niệm chất lượng
• Các phương thức kiểm soát chất lượng
• Khái niệm quản lý chất lượng
• Các phương thức quản lý chất lượng trong nhà máy
SX thực phẩm
CHƯƠNG 4
• Hệ thống QLCL theo ISO 9001:2008
• Hệ thống QLCL theo GMP, SSOP, HACCP, ISO 22000,
FSSC 22000, SQF, IFS, QHP, QACP, QMS, TQM, BRC,
Kosher, HALAL,…
• Các phương pháp, kỹ thuật và công cụ QLCL
(Fish bone diagram, 5 Why, Is and Is Not, Thống kê,
Brain storming, PDCA, 5S, FMEA,...)
• Vai trò quản lý của nhà nước đối với hoạt động QLCL
CHƯƠNG 5
• Kỹ năng mềm: kỹ thuật đào tạo và huấn luyện cho
người khác
HÌNH THỨC ĐÁNH GIÁ
• 10% chuyên cần
• 30% thảo luận nhóm và trình bày
• 60% thi cuối khóa (trắc nghiệm và tự luận)
 CHƯƠNG 4
Tìm hiểu về các HT QLCL theo ISO 9001:2008, GMP,
SSOP, HACCP, ISO 22000, FSSC 22000, SQF, IFS, QHP,
QACP, QMS, TQM, BRC, Kosher, HALAL,…
Các phương pháp, kỹ thuật và công cụ QLCL
(Fish bone diagram, 5 Why, Is and Is Not, Thống kê,
Brain storming, PDCA, 5S, FMEA,...)
FOOD SAFETY AND QUALITY
FSSC 22000

ISO 22000
ISO 9000

QACP
HACCP

GMP

https://www.researchgate.net/
 FOOD SAFETY AND QUALITY LEGISLATION
 GMP’s - Good Manufacturing Practice
The minimum legal demand of safety for aseptic food processing
FSSC 22000
 HACCP - Hazard Analysis and Critical Control Points
A tool for assessment of HEALTH hazards, risks and identification of subsequent ISO 22000
critical control points
 QACP - Quality Assurance Control Points
ISO 9000
A tool for assessment of SPOILAGE hazards, risks and identification of
subsequent critical control points
QACP
 ISO 9000 - International Organization for Standardization
Quality level is re-assured and documented
HACCP
 ISO 22000
All above could be integrated in this Food Safety Management System
GMPs
► FSSC 22000- Food Safety System Certification
Is used to control food safety risks .
/5
 CÂU HỎI THẢO LUẬN NHÓM & BÀI TẬP TÌNH HUỐNG

1/ Trình bày hiểu biết của bạn về Hệ thống IFS và SQF. Cho ví dụ vài trường hợp áp dụng cụ thể.

2/ Trình bày hiểu biết của bạn về Hệ thống TQM. Cho ví dụ vài trường hợp áp dụng cụ thể.

BÀI TẬP TÌNH HUỐNG

Giả sử nhà máy ABC (thành lập vào tháng 6/2019, có trụ sở tại KCN Vĩnh Lộc, Q.Bình Tân, Tp.HCM, chuyên
sản xuất các nguyên liệu bột trà, bột kem không béo, hạt trân châu dạng viên bột, cung cấp cho các chuỗi
kinh doanh trà sữa) đã xây dựng thành công hệ thống chất lượng ISO 9001:2015 vào tháng 12/2019, hệ
thống GMP và SSOP vào tháng 03/2020 và hệ thống HACCP vào tháng 8/2020. Vào tháng 10/2021, Ban giám
đốc nhà máy đề ra mục tiêu xây dựng và đạt chứng nhận hệ thống ISO 22000 và FSSC 22000 vào tháng
10/2022.

Một ban dự án gồm các trưởng bộ phận QA, QC, Sản xuất, R&D, Kho, Thu Mua, S.H.E., Kỹ Thuật, Hành chính
nhân sự, Tài chính,… phụ trách tham gia và hoàn thành mục tiêu này. Đóng vai trò của họ, các bạn cần chuẩn
bị và thực hiện những việc gì để đạt mục tiêu trên?
 BÀI TẬP NHÓM

Mỗi nhóm chọn ra 4 công cụ (tùy thích) trong số 18 công cụ được kể tên ở trang sau để làm bài thuyết trình
ppt và file word.

Các nhóm chỉ được trùng nhau 1-2 công cụ.

Mỗi nhóm có 25 phút thuyết trình, với nhiều thành viên cùng trình bày.

Trình bày hiểu biết của các bạn về các công cụ, kỹ thuật trong quản lý chất lượng sau:

Gơi ý:

Sử dụng cách tiếp cận 5W1H để trả lời cho các câu hỏi dạng What? Why? Who? When? Where? Và How?

Cho ví dụ về 1 vài trường hợp cụ thể

 BÀI TẬP NHÓM

Các công cụ, kỹ thuật trong quản lý chất lượng thường gặp:
i. Biểu đồ xương cá (Fishbone diagram)
ii. Phương pháp 5 Why
iii. Phương pháp “Is và Is Not”
iv. Bảy loại công cụ thống kê về chất lượng
v. Phương pháp tấn công não (Brain storming)
vi. Chu trình PDCA
vii. Phương pháp 5S
viii. Phương pháp FMEA (Xử lý sai lỗi)
ix. Phương pháp vẽ sơ đồ tư duy với MindMap và Sketchnoting
x. Phương pháp GEMBA Walk
xi. Phương pháp KAIZEN
xii. Phương pháp sản xuất tinh gọn (LEAN MANUFACTURING)
xiii. Phương pháp DMAIC và Six sigma
xiv. Kỹ thuật phỏng vấn tại hiện trường bằng câu hỏi mở và câu hỏi đóng
xv. Kỹ thuật tổ chức 1 cuộc họp hiệu quả
xvi. Kỹ thuật tạo mục tiêu, lên kế hoạch, phân công công việc và giám sát mục tiêu, đánh giá kết quả
xvii. Phương pháp truy xuất nguồn gốc sản phẩm - ngược và xuôi (traceability)
xviii. Quy trình tiếp nhận và xử lý khiếu nại khách hàng
 Main drivers of food safety

► Consumer awareness boosting

food safety demands
► Food safety legislation and standards (FDA, EU,
Codex, ISO etc. and local regulations)*
► Retailer’s Global Food Safety Initiative, GFSI and
BRC standard
► Brand protection

Food Distribution
Farming Consumption
production retailing

* Link to Legislation Training Material for more information

 Safety •Food does not affect consumer health

•Compliance with customer requirements

Quality
and satisfaction

•Compliance with legal and regulatory

Legality
requirements

•Ensure that raw materials, supplies and

Authenticity
final products are not adulterated

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OVERALL CHALLENGES OF LIQUID FOOD MANUFACTURING
…and the implications for food quality and safety

Quality control cost and competence

Regulatory pressure increasing
Consumer quality
Quality of incoming raw material difficult is more transparent
to control
Retailer quality requirements
Difficult to contain/eradicate issues increasing
Struggle to control production process

/ 11
TRACEABILITY
WHAT IS TRACEABILITY?
 Traceability is the process that enables you to see the movement of product, at the
smallest saleable units level, across the value chain.

You can Track Forwards to see the intended route of the product towards to the point of care.
And you can Trace Backwards to identify the history of the transfers and locations of the
products.
TRACEABILITY IS BECOMING MORE IMPORTANT BY THE DAY
All food producers need a traceability system to track:

 Origin of all ingredients

 Processing history of all products

 Distribution of all products

Warehouse/
Processing line Packaging line Distribution
raw material

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TRACK PRODUCTS AND ALL RELEVANT PROCESSING DATA
Foundation for traceability from gate to gate

Secure food safety and high, consistent product quality

CLOUD
Support fulfilment of regulatory and industry
traceability demands
ERP
Save time and increase data quality – efficient data collection and
digitalisation of records

Build and protect your brands with traceability

and transparency
MES Suite
Easily access data in interactive reports for fast, effective root cause
analysis and to demonstrate traceability in audits

Enable communication of credence attributes

to consumers

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 FOOD SAFETY
AND
QUALITY MANAGEMENT
LEGISLATION AND REGULATIONS
WHAT IS THE DIFFERENCE BETWEEN FOOD QUALITY AND FOOD
SAFETY?

/ 17
 FOOD QUALITY
- The totality of the features relevant to the ability of the product, to fulfil its requirements
ISO 2005

Examples: Ensuring consumers get high quality

Mass/volume products they enjoy
Nutritional Value
Examples:
Formulation Appearance
Ingredients - colour
Smell
Taste
Internal External Fresh
Specifications Specifications

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 FOOD SAFETY
- The process of preventing food from risks and hazards, which can adversely affect the consumer

/ 19
 IMPORTANT NOTE

Food Safety (HACCP) is not the same as Food Spoilage (QACP).

Food can be spoiled and have NO health risk to the consumer.

Food quality is that the product produced Food safety is - product produced safe for
meet the required specifications and design. human consumption
/ 20
HOW DOES FOOD SAFETY HAPPEN?

LOCAL LEGISLATION
LOCAL LEGISLATION

 National and state/provincial authorities

 Define the Food Standards
 Provide the legally enforceable rules
E.g. Food Act
 Defines requirements for food manufacturers
 Food companies must comply with the Food Standards
 Food companies must implement a food safety programme

 Enforcement of the rules

 Other authorities
 National testing authority, Import/export, fair trade legislation, etc.

/ 22
 EXAMPLE OF LOCAL LEGISLATION (AUSTRALIA)

 Food Standards Australia and New Zealand (FSANZ)

 Develop the Food Standards Code
 Some parts shared between Australia and New Zealand
 No ability to enforce

 States and Territories

 Each has its own Food Act
 Food companies must comply with FSANZ Food Standard Code
 Food companies must implement a food safety programme
 Only sell safe and suitable food

 Food Authority
 Most states have a single authority covering paddock to plate
 Responsible for enforcement of food safety

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HOW DOES FOOD SAFETY HAPPEN?

INTERNATIONAL FOOD SAFETY STANDARDS

INTERNATIONAL FOOD SAFETY STANDARDS (EXAMPLES)

FSSC 22000 Standard Food

Safety

Global Red Meat Standard

BRC Global Standard for Food Safety Food

Safety
and
Quality
Safe Quality Food (SQF)

International Featured Standard (IFS) Food Standard

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COMMON COMPONENTS OF INTERNATIONAL FOOD SAFETY STANDARDS

Components
• Internal auditing programme
• HACCP based risk
assessment for food safety
FSSC 22000, hazards
BRC, SQF, IFS, • Pre-requisite programmes
etc. • Suitable premises and
equipment
• Records are maintained
• Statement to follow relevant
local food legislation

/ 26
 GLOBAL FOOD SAFETY INITIATIVE

 Benchmarking of International Food Safety

Standards
 Achieved by comparison of each standard against a
GFSI guidance document
 Objectives are to
 Encourage equivalence and convergence between the
standards
 Eliminate redundancy and improve operational efficiencies
 Develop competency and capacity building in food safety
 Create consistent and effective food safe systems

/ 27
Food Protection Support May20
MATERIAL IN FOOD CONTACT, A LEGAL DEMAND AROUND THE WORLD

...TELLS YOU WHAT AND WHY, BUT NOT HOW…

FDA EFSA MoH XFDA

Food and Drug European Food China Ministry Local Food & Drug
Administration Safety Authority of Health Administration

Consequences if not fulfilling the legislation;

Withdrawal, sales stop
Fines
Imprisonment
Execution
/ 28
MATERIAL AND PARTS IN FOOD CONTACT

Intended use, is key – The selected article, material and component must
withstand impact of the food to be produced, including additives as well as
detergents and sanitizers to be used.

- Always secure the selected article, material and component are hygienically designed (if used for
food processing and have safe approved material when used in food contact or indirect food
contact.
- Don´t forget the need of traceability, a legal demand in Europe, dummy article numbers not
allowed to use.
- Locally selected material must have an assigned Product Owner securing legal compliance

/ 29
ALLERGEN LABELLING LEGISLATION

Global differences

Important for food producer to know the requirement of the target

market

Important to understand differences in legislation

/ 30
FOOD SAFETY PROGRAMMES
FOOD SAFETY PROGRAMMES

Local Legislation and Require food manufacturers

Define what a Food Safety
to have a Food Safety
Food Safety Standards Programme Programme must address

Food safety plans,

procedures, specifications, Defines what an
Food Safety Programme methods and work organisation will do
instructions

Records Records, reports, test results Evidence that procedures

were followed

/ 32
FOOD SAFETY PROGRAMME

Internal auditing programme

HACCP based risk assessment for food safety hazards

Pre-requisite programmes

Suitable premises and equipment

Records are maintained

/ 33
PRE-REQUISITE PROGRAMMES

Calibration
Cleaning
Good Hygienic Practice
Pest Control
Approved Supplier programme
Maintenance
Document Control
Training
Labelling
Product Identification and Traceability Specific pre-requisite programme
Incoming material requirements requirements are detailed within individual
International Food Safety Standards
Allergen management
Recall procedures / 34
WHAT ABOUT CODEX ALIMENTARIUS?
CODEX ALIMENTARIUS
Provides a collection of standards, guidelines and codes of practice to:

Promote uniformity in manufacture and supply of safe and wholesome food

Enable harmonisation of definitions and requirements for foods

Ensure fair practices in the food trade

Facilitate international trade

Reference material for development of national standards

/ 36
 General Principles of Food Hygiene (CAC/RCP 1-1969 (Rev 4 - 2003))

CODEX ALIMENTARIUS

Recommends
Provides foundation Refers to “food safety” application of a
for ensuring food and “suitability for HACCP-based
hygiene consumption” approach as a means
to enhance food
safety

There is no similar
(= Food safety and
food quality) CODEX
recommendation
for enhancing food
quality

/ 37
FOOD SAFETY AND QUALITY MANAGEMENT
FOOD SAFETY AND QUALITY MANAGEMENT
Quality Management System
• Incorporates food safety and food quality

Food Safety
• Codex Alimentarius, Local legislation and International Food Safety Standards

What about Food Quality?

• There are no internationally accepted standards or guidelines that specifically
address food quality
• There is no equivalent process to the HACCP concept for food quality

/ 39
 SAFETY QUALITY FOOD (SQF) CODE

Unique amongst
International Food
Safety Standards in
that it provides a
comprehensive and
separate food quality
code

/ 40
WHAT ABOUT FOOD QUALITY?

ISO 9000 series for

quality International Food
SQF Code QACP
management Safety Standards
systems

Many indicate a Food safety codes

Nothing specific for requirement to for primary Approach for
address food quality, production,
food quality
but with limited manufacturing,
food quality
detail storage and
distribution, food
packaging, retail
and food service

Food quality code,

comprehensive and
based on HACCP

/ 41
/ 42
FOOD SAFETY AND
QUALITY ASSURANCE MANAGEMENT
Food Safety and Quality Management
1. Hazard analysis and preventive controls
HACCP vs QACP
Contamination, Chemical and foreign bodies, material in food contact

2. Quality ingredients
Raw material

3. CIP and Cleaning

Food Allergen preventive Controls

4, Process Preventive Controls

CP and CCP
Food Safety Charts

5. Quality system in production

QACP
/ 44
 1. HAZARD ANALYSIS
PREVENTIVE CONTROLS
Principles of HACCP and QACP

/ 46
HAZARD ANALYSIS AND PREVENTIVE CONTROLS DETERMINATION

If a point is not a Food Safety CCP,

But will spoil the product

It is a CP for your QACP programme

/ 47
 HACCP
Unintentional
Contamination QACP
Contamination
Risks to Product Intentional
Contamination Food Defense
Biological
Product Control
SAFE
Chemical
LEGAL Process Control

Physical QUALITY
Infrastructure Control

Allergens Process failures and Risks

controls Evaluation

Adulteration Food Fraud

/ 48
RISK ANALYSIS FOR FOOD SAFETY AND QUALITY
Consequence analysis
Probability analysis

Source Event Consequenses

(Risk)
SEVERITY ASSIGNMENT
CRITERIA

Causal
Factors
Analysis of controls Existing Control
PROBABILITY ASSIGNMENT
CRITERIA

/ 49
RISK ANALYSIS CONSIDERATIONS
In food management there are 4 approaches to reduce or eliminate a hazard that creates a risk

Supply Chain (in the provider)

•For raw materials or supplies that require control from the supplier

Prerequisite programmes
•The programmes aim to reduce the appearance of dangers and sources of risks, which affect
the quality or safety of products.

Critical Control Points (Process)

•Process or stage with factors and variables to monitor, corrective actions, monitoring
mechanisms, to prevent significant hazards from appearing above levels not required

Control Points (Process)

•Actions that focus on controlling the appearance of dangers and risks that are relevant.
Could be extended to supplier and customer as control measures. Critical limits and forms of
monitoring must be defined.
/ 50
 RISK LEVEL

Risk
Probability Severity
Level

Qualitative and / or Characteristics of the

quantitative variables of impact areas:
occurrence factors Exposure, coverage,
resilience, etc.

/ 51
RISK ANALYSIS

Consequence in:

Safety

Legality

Quality

Brand name
Finance
Business
/ 52
HAZARD ANALYSIS AND PREVENTIVE CONTROLS

Contamination, Chemical and Foreign bodies

Correct and certified material in food contact

/ 53
Contamination, Chemical and Foreign bodies
Understanding the risks associated with each can dramatically reduce:
Foodborne illness.
Food quality deviations.

Biological

Chemical

Physical

Allergenic

/ 54
HAZARDS AND CONTAMINATION
Define the difference between
a food quality contamination and
a food safety risk

Example: Example:
NaOH – QACP Paper – QACP
Antibiotics - HACCP Glass - HACCP

Example:
Micrococcus – QACP
B.cereus 104 - HACCP

/ 55
MICROBIOLOGICAL QUALITY AND SAFETY

Microbiological causes

 Bacteria
 Moulds
 Yeast
 Etc
 MICROBIOLOGICAL QUALITY AND SAFETY

Bacteria, health risk and food spoilage;

 The most common organisms that spoil low-acid food. A few of

these are foodborne pathogens
 A main part of microbiological problems in the food industry is
related to food quality.
 Some spoil high-acid food, although none of these are food
pathogens.
 Some can form spores and some produce toxins and toxins is
not affected by the kill step.
 GROWTH FACTOR: ACIDITY – KNOW YOUR MICROBIOLOGY!

Moulds What does a pH of 4.6 mean?

Yeast
Pathogens do not grow below 4.6, however
other micro-organisms do…
Bacteria

pH
0 2 4 6 8 10 12 14
Milk
Fruit juices

Vegetable juices
Tomato products

Meat, vegetables, soup etc. Low Acid Food

High Acid Food
4.2
4.6

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 MICROBIOLOGICAL QUALITY AND SAFETY
Bacteria, special characteristics, gram negative;
 The Gram negative, which have a very thin cell wall and occur only as vegetative cells.
This group contains the great majority which are also able to multiply at refrigeration
temperatures.
 Very low resistance to desiccation, chemicals and heat.
 Heat sensitive ~72C
 Usually spread by water.

Food Quality Examples: Food Safety Examples:

Pseudomonas Salmonella
Aeromonas E. coli
… Shigella
 MICROBIOLOGICAL QUALITY AND SAFETY

Bacteria, special characteristics, gram positive;

 The Gram positive group, which has a thick, rigid cell wall. By far the majority occur only as
vegetative cells.
 A small number of gram positive microorganisms can sometimes occur as spores.
 Often withstands desiccation.
 Low resistance to heat and chemicals. However spores are very resistant to heat.
 Usually spread by air, but also by water.

Food Quality Examples: Food Safety, Examples:

Micrococcus Bacillus cereus (104)
Lactobacillus Strep. faecalis
Bacillus, Strep, Staph, sp. Staph. aureus

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MICROBIOLOGICAL QUALITY AND SAFETY
Fungi – Yeast and Mould
Yeasts and moulds grow best within the range from 20 to 30°C, and at pH 4-6. All grow on organic
material.

Yeasts, are single-cell organisms of spherical shape.

 Yeast is most common organisms that spoil high-acid food. There are no food pathogens.
 exhibits low to medium resistance to desiccation, chemicals and heat (Zygosaccharomyces)

Food Safety, Examples:

None

Food Quality Examples:

Candida
….. all

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 MICROBIOLOGICAL QUALITY AND SAFETY

Fungi
Yeasts and moulds grow best within the range from 20 to 30°C, and at pH 4-6. All grow on
organic material.
 Moulds, multicellular, threadlike fungi.
 All have a very thick cell wall. The majority can occur both in vegetative form and as
spores.
 By far most fungal spores are spread by air.
 Moulds may spoil high-acid food but both can also spoil low-acid food.

 A small number of fungi are carcinogenic or allergenic and can produce toxins

Food Quality Examples: Food Safety, Examples:

Byssochlamys Penicillium
Mucor Aspergillus…
Rhizopus Aflatoxins/mould allergies

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 REDUCING OR ELIMINATING MICROORGANISMS

Heat treatment

Using heat treatment* in the kill-step. Any heat treatment process used to process
unprocessed food must be able to;

Goal: Raise every part of the product to a given temperature for a given period of time

It must be ensured that the process used, achieves the desired objectives i.e. regularly
checking of main relevant parameters (particularly temperature, time, flow, etc.)

• Example of other type of treatments; high pressure, radiation, Pulsed Electrical Field, etc.
** Logarithmic reduction, absolute sterility not possible.

The process used should conform to an internationally recognised standard (e.g. pasteurisation, UHT / commercial
sterilisation** as defined in Codex Alimentarius or US FDA CFR Title 21 or European Regulation 852/2004/EC.

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LEGAL DEMANDS

Low acid food

 Pasteurisation and UHT is well defined in the legislation CODEX CAC/RCP 57 2004
 EC No 852/2004, EC No 853/2004, EC No 2074/2005, EC No 1662/2006, EC No 2073/2005
and EC No 2023/2006
 FDA 21CFR 113, 21CFR1240.61 and 21CFR131.3, Grade ”A” pasteurized milk ordinance, FDA 21
CFR 117
 Ultra pasteurization (21CFR131, USA)

No specific standards for ESL products

High acid food

 Juice 5 log pathogen reduction in US

/ 64
 CONTAMINATION, CHEMICAL

Substances intentionally added during food

production.
For instance, as food additives, prolong the shelf life of foods additives, or
colours and flavourings, they may make foods more attractive, etc.

Substances from food processing and filling

equipment or food containers
They can range from metals traces, lubricant, detergents, chemicals, foreign
bodies, etc

Substances present in ingredients or raw

material.
These contaminants are unintentionally present and can often not be
avoided
(pesticides, organic matter, veterinary drugs, environmental pollution, etc).
/ 65
Contamination, Chemical

All relevant Food Contact Material Legislations worldwide request

that migration or particles from food contact materials should;

not endanger human health

not change the organoleptic properties of the packed product

not change the composition of food in an unacceptable way

/ 66
 CONTAMINATION, CHEMICAL - DETERGENTS
Always recommend pure HNO3 and NaOH, however a few of our customers are using additional additives or
detergents.

Substances to Water Oxidants Non- Enzymes

surfactants Ingredients that
modify pH softeners (oxidizers) modify the
Surfactants affect used to for materials that to digest foaming
Abrasives performance/ counteract bleaching keep dirt in proteins, fats, properties
to 'cut' grease stability of and suspension
and to wet to scour the effect of or of the cleaning
ingredients, for "hardness" destruction carbohydrates
surfaces of dirt surfactants, to
descaling or ions on in dirt or to either stabilize or
caustics to other modify fabric counteract foam
destroy dirt ingredients feel

Secure detergents are not mixed with the product.

Note:- some ingredients may induce corrosion and can be toxic to aquatic life.
/ 67
CONTAMINATION, CHEMICAL - LUBRICANTS
Lubricants
Only NSF approved ”Food Grade” lubricant type H1 is allowed, lubricant posted NSF “white list”
don’t justify use in direct or indirect food contact

 In US the allowed amount of lubricant in food contact is 10mg/L.

 In EU lubricant in food contact is not allowed; limit is “zero”.

Older synthetic food grade lubricants often use substances to limit microbiological growth and
some of the substances are also used as pesticides with environmental restrictions.

Always try to design away risk of incidental food contact

- if not possible use food grade lubricant, with NSF type approval H1.
Contamination, Chemical - corrosion

/ 69
 CONTAMINATION, CHEMICAL – METAL IONS

Migration of metal ions is not a problem if correct alloy is selected with respect to
the food to be produced.

For combined products the recipe and production parameters must be considered, as well as type
of detergent used.

Food Protection Support

/ 702020
 CONTAMINATION, FOREIGN BODIES
Discovering a foreign object in food does not necessarily pose a serious health risk.

We can consequently divide them into two broad categories:

1. Food which is unfit for human consumption i.e.

Food which contains a foreign object which poses a serious health risk - HACCP
and
2. “Accepted” contamination but can be perceived by consumers as a food safety issue - QACP

/ 71
CONTAMINATION, FOREIGN BODIES

Physical contamination - Foreign bodies,

 Stainless steel

 Rubber

 Glass

 Ceramics

 Plastic

 Paper

 Insects

 Soil & dirt during maintenance

 CONTAMINATION – PLASTICS & RUBBER

Quality and substances used differs between manufacturers of food grade material, depending on
technical characteristics.
The actual substances included must be on the positive list in EU and US.

Approved substances are listed and must not contain any toxic matter or SVHC substances and migration of
chemicals must be within approved limits.
Plastics normally are very well regulated and allowed migration limits specified. Tests to be done using
simulants.

Within EU regulation 10/2011 is applicable for plastic and in US FDA CFR 21 for plastic and rubber.

Always secure use of rubber gaskets approved for the specific types of food and processing/cleaning parameters. Must be in
line with the legislation in the market of sales. A Declaration of Compliance is necessary to prove legal compliance in Europe,
fulfilling regulation 1935/2004/EC.

/ 73
RUBBER IN FOOD CONTACT
Failure mechanisms;

Too high temperature

- Ageing and degeneration of the material, cross-links are broken leads to loss of functionality.
Too low temperature
- Increase in tensile strength and hardness with decrease in elongation at break. Risk of brittle cracking.
Thermal expansion
- In combination with fluid uptake volume may increase up to 200%, can crack but also result in dead spot or
traps affecting cleaning.
Deformation / Extrusion
- Hardness important to secure tightness and compression can cause untightness or seal material can be
extruded into the product flow and crack.
Swelling / Shrinkage
- Often caused by chemicals or temperature. Acceptable swelling during normal conditions is up to 15%.
Shrinking can be more serious due to loss of seal effectiveness.
Abrasion
- Caused by aggressive product in combination with dynamic application.

/ 74
 CONTAMINATION, FOREIGN BODIES
Accepted Foreign objects in food
Some foreign objects (mainly of natural occurrence) are accepted, for instance:

US FDA allows up to 30 insect parts or vermin hairs for each 100 grams of peanut butter
because it’s virtually impossible to remove all particulate matter from it.

US FDA allows in flour an average of 75 or more insect fragments per 50 grams. Average of 1 or
more rodent hairs per 50 grams.

In Europe the basic principle is ”zero” but in reality the producer must show the food is safe
before it is placed on the market.

/ 75
CONTAMINATION, FOREIGN BODIES - INSECTS
Other material in food contact:
Insects

Can enter the process via ingredients, secure high-quality ingredients, good
house keeping and closed storage area

Closed processes - Openings to atmosphere, such as tank ventilation, secure

filters or mesh in place

Open processes – open equipment, several possibilities, secure good house

keeping and barriers at room entries

Filling machines – enter via paper feed track but crushed by paper rollers,
easier entry if cups or similar are used

Maintenance – equipment open for shorter or longer periods, secure good

house keeping and clean surroundings
When necessary secure entry points of building or door by barriers and/or
install bug traps, UV insect killer or similar.
/ 76
HAZARD ANALYSIS AND PREVENTIVE CONTROLS DETERMINATION

Contamination, Chemical and Foreign bodies

Correct and certified material in food contact

/ 77
 Correct and certified material in food contact

INTENDED USE
Material and parts in food contact:
The selected article, material and component must withstand impact of the food
to be produced, including additives as well as detergents and sanitizers to be
used.

/ 78
 Intended Use
MATERIAL IN FOOD CONTACT
Compliant with the legislation
► Regulation for material in food contact
− Corrosion resistant
− Non-toxic
− Inert to product, Not transfer undesirable odour, colour, or taint to the food.
− Surfaces of materials and coatings shall be durable
− Possible to trace material one step up and down in the supply chain (EU & China)
− Specification of material documented;
Certificate of compliance

► Specific directives & regulations

− Plastic material
− ceramic material
− rubber, etc
/
79
HOW CLEAN IS CLEAN?

Definition of cleanliness according to International Dairy Federation(IDF):

”A clean surface is one which is free of residual film or soil and will not
contaminate food product in contact with it.”

/ 80
EFFICIENT CLEANING

CIP / COP

Food Allergen preventive Controls

/ 81
WHAT SHOULD CLEANING REMOVE?
 How a plant that has been processing food should be cleaned depends on the type of food
produced, and under which conditions
 Processing temperature and running time affect how the equipment will be soiled

 Soil (or fouling), deposited on the walls of the equipment comes from the food product that
is processed
Juice
White milk Cream

Soups
Desserts
Flavoured and
formulated drinks
Tomato preparations
/ 82
 MAKING THE LINE READY FOR PRODUCTION

 Sterilization is performed in aseptic processing lines and lines for extended shelf life (ESL)
products.
 Inactivates all microorganisms

 Disinfection is used in non-aseptic production lines

 Inactivates pathogenic microorganisms and reduces the total amount of microorganisms

Require a successful cleaning first

/ 83
MICROBIOLOGICAL

 Avoid spreading the contamination – don’t use high pressure equipment during external cleaning.

 Foam cleaning and flush with water at low pressure, recommended – when there is no production.
ALLERGENS
What is an allergen?

Allergens are (cannot be compared to

Food allergy proteins
microorganisms which
symptoms vary in • often withstand will be inactivated when
severity food-processing heated to relevant
conditions temperature)

Food allergy are

characterised by
release of chemicals in
the body that cause
symptoms
/ 85
FOOD ALLERGEN TYPES

/ 86
ALLERGEN RISK ASSESSMENT

Many foods contain

ingredients which are known
allergens and must be
labelled according to
legislation

Food allergens can also

Implementation of Food Safety become part of food
management systems through unintended
(GMP,GHP, HACCP etc) exposure e.g.
shared equipment
/ 87
 ALLERGEN RISK MANAGEMENT
Unintentional exposure
 What is the risk?
 Cross contamination

 How can the risk be managed?

 Evaluation of the likelihood of allergen cross contamination from raw material to finished
product
 People awareness/training
 Zoning/preparation
 Raw materials/supply chain/rework
 Cleaning

/ 88
4. PROCESSES CONTROL POINTS
AND
CRITICAL CONTROL POINTS
CP & CCP
PROCESS PREVENTIVE CONTROLS

 Control Points and Critical Control Points

 FSC

/ 90
 CONTROL POINT VS CRITICAL CONTROL POINT

A control point (CP) is work which is aimed at checking of the

compliance of the results of certain work in a business
process with formulated requirements to its results.

A critical control point (CCP) is defined as a step at which

control can be applied and is essential to prevent or eliminate
a food safety hazard or reduce it to an acceptable level.

/ 91
 PRE-PROCESSING PARAMETERS – CONTROL POINTS

Process

Good Mixing with suitable formulation Sufficient hydration time Pasteurization (as necessary)

Controlling intermediate product quality waiting for UHT process

Storage temperature and time Gentle agitation to prevent product separation/sedimentation

Clean product contact surfaces

Proper cleaning (CIP) between every batch

/ 92
PRODUCTION PARAMETERS – CONTROL POINTS

Viscosity and flow

Wet or dry product pH pattern (shearing
forces)

Protein content and Sugar content and Fat content and

type type type

Microbiological
Type of enzymes - profile – unwanted
Temperature
inactivation possibility to form
toxins

Flow Time Conductivity

/ 93
 FOOD SAFETY CHART (FSC)

The FSC covers

The FSC provides an ONLY Food Safety
overview of food
Food Safety safety-relevant aspects
It is a support tool information related to
Chart (FSC) is suitable for any equipment
designed to preventive food functionality
support the safety-oriented • does not address other
establishment of analysis or important aspects of a
for the different process food manufacturing line
customer HACCP programme steps, as well as such as food quality, line
plans operational and efficiency, production
preventive maintenance planning issues, etc.
requirements

/ 94
 HOW TO USE THE FSC?

Column / Item Definitions

Process Step Name of the process and description of the method used for the process

Food Safety Concern Food safety hazard(s) addressed by the process step

Control parameter Parameter(s) regulating the correct functioning of the process step

Value(s) of the control parameter that triggers a system response when reached or
Critical Limit exceeded

Value or range of values of the control parameters at which the process is designed
Target Value to operate

/ 95
HOW TO USE THE FSC?

Column / Item Definitions

Where automatic monitoring is implemented, the appliance in place to monitor
Monitoring procedure the control parameter is indicated. Otherwise, the manual monitoring procedure is
indicated.

Frequency Type and timing of the automatic or manual monitoring procedure

System response in case of

(automatic monitoring only) Automatic corrective action taken by the equipment
infringement of the Critical when the automatic monitoring procedure detects a violation of the critical limit
limit
Actions or procedures required by the automatic system response of the manual
Requirements action to operate properly and effectively

Reference document
Equipment-specific manuals for detailed information regarding CP, CL, TV, etc.
(Ref. Doc.)
/ 96
HOW TO USE THE FSC?

Legend colour coding Definitions

No automatic monitoring / control – recommended to be

Grey background considered in HACCP or other food safety plan

Automatic monitoring / control – probability of failure low

White background provided listed requirement is met

/ 97
FOOD SAFETY CHART (FSC)

Chapter Description

1.1 Process step preparation

1.2 Process step production

1.3 Process step cleaning

1.4 Maintenance and utilities

/ 98
FOOD SAFETY
Critical control points

/ 99
 5.
QUALITY ASSURANCE SYSTEM
- IN PRODUCTION
 QACP : KEY OBJECTIVES
To ensure End Product Quality
To allow efficient troubleshooting

QACP : Hazards
Biological : ALL micro-organisms

Gram negatives, Gram positives, Gram

positive sporeformers, yeast, moulds

Chemical : Residues of agents

Physical : Foreign materials

Spore

/ 101
 QACP : IDENTIFY CPS
To ensure end product quality

To allow efficient troubleshooting

Microbiology Root cause Product

hazards Identification spoilage

Low Acid
Gram Negatives Gram Negatives
Gram
Critical Verify Gram Positives
Gram Positives Limits
Identify Control
Spore formers Control Points Spore formers
Points - in relation
Monitoring to the micro- Enzymes
Enzymes
Procedure organism
Yeast Spore Yeast
Corrective
Mould Action Mould
/ 102
 QACP : IDENTIFY CPS
To ensure end product quality

To allow efficient troubleshooting

Microbiology Root cause Product

hazards Identification spoilage

High Acid
Gram Negatives Gram Negatives
Gram
Critical Verify Gram Positives
Gram Positives Limits
Identify Control
Sporeformers Control Points Sporeformers
Points - in relation
Monitoring to the micro- Enzymes
Enzymes
Procedure organism
Yeast – gas & non-gas Spore Yeast – gas & non-gas
Corrective
Mould & HRM Action Mould & HRM
/ 103
QACP Analysis:
Example: Low Acid UHT

Result = Process Survivors + Re-infection

1. Process Survivors = Load vs. Process

• UHT pre-sterilization
• Product sterilization
2. Re-infection = Tightness
QACP Analysis:
HAZARD: PRODUCT SPOILAGE DUE TO CONTAMINATION WITH GRAM+
SPORES

Control Critical Limit Monitoring Preventive Corrective

Process Max.
Parameter Min. Nominal procedure measures actions

Product
Time Capacity
Sterilization

Length of
holding tube

Steam
pressure

▲P
▲T

Max.
production
length

Thermo
Temperature
sensor
 Thạc sỹ Nguyễn Long Duy

Trình độ học vấn

- Kỹ sư “Công Nghệ Thực Phẩm”, ĐH Nông Lâm TpHCM, 2005
- Thạc sỹ “Chăn Nuôi, Vệ Sinh, Môi Trường và Chất Lượng”, ĐH Francois Rabelais De Tours, Pháp,
và ĐH Nông Lâm TpHCM, 2006
- Thạc sỹ Quản Trị Kinh Doanh Quốc Tế, CFVG & ĐH Kinh Tế Tp.HCM, 2013
- Cử Nhân “Ngôn Ngữ Anh”, ĐH Sài Gòn, 2021

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SECURITY LEVEL Initials/YYYY-MM-DD / 106
MSc., MBA, NGUYEN LONG DUY
Email: nlongduy@gmail.com
Mobile phone: 0938 872 720