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TQM

ISO 9000

QACP

HACCP

GMP/GHP

Stairs to TQM (Total Quality Management)

Traditional control

Surprise – swoop
Unrepeatability
Irregularity
Inaccurate scope and evaluation
Revealing faults not in all production steps
Rating on the base of final product

Good Manufacturing Practice

Buildings and surroundings
Machines and tools
Trainings
Storing and distribution
Cleaning and disinfection
Staff hygiene
Raw materials and supplementary materials

General plans

for:

Testing plant water
Removing waste and sewage
Pests control
Cleaning and disinfections
Control for health status

Plans and drafts

General plan of plant with surroundings – horizontal view, zoning
Technological line draft
Waste remove ways
Additives and packages input ways
Requirement for physical parameters for space: humidity, temperature, light, and ventilation
Air stream directions

HACCP history

’50 NASA demand to safety food for astronauts

1959 Pilsbury Company + NASA + Natic Laboratory (US Army) + US Air Force Space +

Laboratory Project Group

1975 WHO System acceptance

1980 General basics and definitions International Commision on Microbiological

Specification (ICMSF FAO/WHO)

1987 Committee for Food Hygiene FAO/WHO (Codex Alimentarius) recommendation to

apply in food plants

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1980 – 1992 National Advisory committee on Microbiological Criteria for Foods

(NACMCF) The HACCP Seven Principles

1993 Codex Alimentarius Commission

HACCP

Hazard Analysis and Critical Control Point

It allows to:
Monitor whole production of food and its distribution
Determine hazards on each step of production and distribution of food
Risk analysis
Eliminate or minimalize particular hazards on individual step of production – it is prevention
HACCP – tools to provide food safety – mainly sanitary aspects of food

The essence of HACCP

HACCP – tool for protection consumers against food origin hazards

HACCP:
Could be applied to ensure other quality expected aspects of food (ie. sensory)
Enables to identify hazards in food production processes
Enables to establish Critical Control Points (places where hazards threaten food quality and
consumer safety)
Enables to monitor hazards in CCP – prevention and elimination
HACCP considered during:
Designing production of new product
Minimizing probability of faulty technological process influencing food safety and quality

HACCP

Specific for individual process, product, plant
Is not transferable to other plant
Is applied to provide food safety and quality
The HACCP principals are universal (common in variety food plant, applied to prevent hazards

Food safety in the HACCP system

Quality control

Raw and

supporting

materials

Staff

Technology

Machines

and tools

Good -

food item

Lack of food safety assurance

HACCP

Raw and

supporting

materials

Staff

Technology

Machines

and tools

Good -

food item

Food safety assurance

The HACCP Seven Principles

According to Codex Alimentarius 1997

Principle 1: Conduct a hazard analysis. Plants determine the food safety hazards and identify the
preventive measures the plant can apply to control these hazards. A food safety hazard is any biological,
chemical, or physical property that may cause a food to be unsafe for human consumption.

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Principle 2: Identify critical control points. A critical control point (CCP) is a point, step, or procedure in a
food process at which control can be applied and, as a result, a food safety hazard can be prevented,
eliminated, or reduced to an acceptable level.
Principle 3: Establish critical limits for each critical control point. A critical limit is the maximum or
minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control
point to prevent, eliminate, or reduce to an acceptable level.
Principle 4: Establish critical control point monitoring requirements. Monitoring activities are necessary
to ensure that the process is under control at each critical control point.
Principle 5: Establish corrective actions. These are actions to be taken when monitoring indicates a
deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the
corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no
product injurious to health or otherwise adulterated as a result of the deviation enters commerce.
Principle 6: Establish procedures for ensuring the HACCP system is working as intended. Validation
ensures that the plants do what they were designed to do; that is, they are successful in ensuring the
production of safe product. Plants will be required to validate their own HACCP plans.
Principle 7: Establish record keeping procedures. The HACCP regulation requires that all plants maintain
certain documents, including its hazard analysis and written HACCP plan, and records documenting the
monitoring of critical control points, critical limits, verification activities, and the handling of processing
deviations.

Food law documents and HACCP

Regulations:

EU
852/2004,
853/2004,
854/2004,
882/2004
Polish
Act of 25

th

of August 2005 on safety of food and nutrition

Act of 16

th

of December 2005 on products of animal origin

HACCP advantages

HACCP enables to demonstrate to all interested parties, plant has done everything to produce safety
food according to food law requirements, good manufacturing practice and consumers needs
DUE DILIGENCE

HACCP scope

HACCP

Raw materials

Animals

purchasing

Processing

Food market

Non obligatory

Obligatory

Non obligatory

Food safety

Food quality

HACCP definitions

HACCP: A system which identifies, evaluates, and controls hazards which are significant for food
safety.
HACCP plan: 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.
CORRECTIVE ACTION:

Any action to be taken when the results of monitoring at the CCP

indicate a loss of control.
CRITICAL CONTROL POINT (CCP): A step in a food process at which control can be applied
in order to prevent a food safety hazard or to reduce its occurrence to an acceptable level.

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CRITICAL LIMIT: A maximum and/or minimum value to which a biological, chemical or
physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable
level the occurrence of a food safety hazard.
DEVIATION.: Failure to meet a critical limit.
HAZARD: For the purposes of HACCP, a food safety hazard is considered any chemical,
biological or physical property that may cause a food to be unsafe to consume. HACCP is not
concerned with properties that may be merely objectionable or that only affect the quality of the
food.
HAZARD ANALYSIS: The process of collecting and analyzing information about hazards for a
particular food under consideration. The likelihood of occurrence and the severity of consequences
are considered with the objective of deciding which hazards need to be addressed in the HACCP
plan.
MONITORING: A planned sequence of observations or measurements performed in order to
determine whether a Critical Control Point is under control and to produce an accurate record.
PROCESS-MONITORING INSTRUMENT means an instrument or device used to indicate
conditions during processing at a critical control point.
VALIDATION: Validation consists of activities designed to determine if the plan, when properly
executed, will effectively control the significant hazards in the process. As such it is not so much
concerned with how employees perform the tasks associated with HACCP, but rather with the
underlying scientific assumptions of the plan design itself. For example, if a plan requires that a
meat product be heated to a minimum center temperature of 160°F – 71,1 °C, validation would seek
to determine if attainment of 160°F would really control all of the organisms of public health
significance that would be expected to be present in that product. Validation is based on an
evaluation of the science and technical data that form the basis of the HACCP plan.
VERIFICATION: Activities (other than monitoring) that determine the adequacy of and
compliance with the HACCP plan. In other words, verification of a plan seeks to determine if the
plan is meeting its own requirements. In practice, verification would be done by reviewing the
written plan for completeness, comparing its elements (such as flow charts) to the actual process to
make sure they are in agreement, observing the actual process to see if monitoring, record-keeping
and corrective actions are being performed according to the plan, and reviewing records for
correctness and completeness. Adequacy of calibration of test equipment would be included in a
verification audit. In most cases the auditor would interview operators to judge their level of
training with regard to HACCP. Most experts and some regulations require a minimum of annual
documented verification of a HACCP plan. Failure to verify can result in a plan becoming obsolete
and ineffective.
CONTROL: To take all necessary actions to ensure and maintain compliance with criteria
established in the HACCP plan.
CONTROL MEASURE: Any action or activity that can be used to prevent, eliminate or reduce a
significant hazard.
PREVENTIVE MEASURE means physical, chemical, or other factors that can be used to control
an identified food safety hazard.
STEP: A point, procedure, operation or stage in the food system from primary production to final
consumption.
CONTROL POINT: Any step at which biological, chemical, or physical factors can be controlled
AUDIT: A systematic and functionally independent examination to determine whether activities
and related results comply with planned objectives

CONTAMINANT: Any biological or chemical agent, foreign matter or other substances not
intentionally added to food that may compromise food safety and suitability. (Codex)
CONTAMINATION: The introduction or occurrence of a contaminant in food or food
environment. (Codex)
CROSS CONTAMINATION: A contamination occurring during the production, processing or
preparation of food, either through direct contact of uncontaminated materials with contaminated
materials or through transmission by a vehicle.

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FOOD HANDLER: Any person who handles packaged or unpackaged food, food equipment and
utensils or surfaces in contact with food and is therefore expected to comply with food hygiene
requirements. (Codex)
FOOD HYGIENE: All conditions and measures necessary to ensure the safety and suitability of
food at all stages of the food chain. (Codex)
FOODBORNE DISEASE (FBD): A disease, usually either infectious or toxic in nature, caused by
agents that enter the body through the ingestion of food. The term "food" includes drinking-water.
Sometimes this is incorrectly referred to as food poisoning.
FOOD POISONING: This is a term that is often used to refer to foodborne illness/disease but
WHO does not recommend it.
FOOD SAFETY: Assurance that food will not cause harm to the consumer when it is prepared
and/or eaten according to its intended use. (Codex)
FOOD SPOILAGE: Food becomes unfit to eat as a result of: growth and activities of
microorganisms, insect infestation, action of enzymes, chemical reactions, and physical changes
(e.g. freezing, burning, drying, pressure, and humidity).
HIGH-RISK FOOD:

These include foods that have been linked epidemiologically to foodborne

disease or that, due to their nature, preparation or storage, present a greater risk of foodborne
disease than other foods.
INFECTION: Entry and colonisation of an infectious microorganism in a living macroorganism
(host). Disease does not always develop but the host becomes a “carrier”.
INTOXICATION: Bacteria such as Clostridium botulinum or Staphylococcus aureus grow and
produce toxin in the food. When the food is eaten the person becomes ill. In contrast to an infection,
the person becomes ill without eating the live bacteria.
MALABSORPTION: Failure to absorb various nutrients.
PRESERVATION: Various methods to extend the shelf life of food (e.g. dehydration, heat
sterilisation, freezing, radiation, addition of preservatives) by inhibiting the multiplication and/or
growth of microorganisms and by minimising chemical and sensory changes.
PRESERVATIVES:

Antimicrobial substances that prevent multiplication of microorganisms and

sometimes also used for preventing other types of undesirable activities.
RISK: A function of the probability of an adverse health effect and the severity of that effect,
consequential to (a) hazard(s) in food.
TARGET Value: A value or characteristic of a physical, chemical or biological nature, used to
assure that critical limits are not exceeded.
VECTOR: Also known as a vehicle. Method of transport for microorganisms to hosts or habitats
(e.g. wind, water, insects, rodents, pets, man, utensils).
VERIFICATION: The application of methods, procedures, tests and other evaluations, in addition
to monitoring to determine compliance with the HACCP plan. (Codex)
ADDITIVES AND INGREDIENTS: Substances added to foods to influence their condition or to
bring about specific characteristics or effects (help manufacture, preserve, improve palatability, eye
appeal, convenience - e.g. emulsifiers, flavours, thickeners, curing agents, humectants, colours,
vitamins, minerals, moulds, yeasts, and bacterial inhibitors).
A

w

(WATER ACTIVITY) VALUE: The ratio of the water vapour pressure over a food to the

saturation pressure of pure distilled water at a given temperature, expressed on a scale of 1.0 to 0.0.
Pure water is 1.0 on this scale (WHO). It refers to the amount of water available for growth and
multiplication of microorganisms.

Steps of introducing HACCP

1. Defining scope of system – food item, technology, raw materials,
2. Establish HACCP team responsible for introducing
3. Describing product – content, structure, technology, packaging, storing, durability, manner of use
4. Describing product usage and target group consumers
5. Work out technology flow chart
6. Verifying technology flow chart

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7. Identifying and listing hazards and ways of preventing them
8. Identifying critical control points (CCP), establishing priorities – use of decision tree
9. Determining expected values and critical limits for identified CCP

10. Determining monitoring system for CCP
11. Establishing corrective action plan
12. Work out verifying procedures – internal audits of HACCP, procedures of HACCP audits
13. Work out documentation and recordings storage
14. Revising HACCP plan

The HACCP team

Specialists in

- quality assurance
- production
- food technology

other:

- microbiologists,
- chemists

Not more that 5 – 6 persons

EXERCISE 1

Preparing product description

-

name

-

brief characteristic

-

form of package

-

weight

-

features (chemical, physical, microbiological)

-

storing conditions,

-

consumers assignment

-

durability

Product description

Name
Characteristic
Package
Sensory features
Weight
Components
Chemical contents

-

proteins

-

water

-

fat

-

carbohydrates

-

water activity

-

pH

Food additives (preservatives, colorants, antioxidants, residues, vitamins, flavorings, emulsifying salts,
emulsifiers)

Microbiological features

-

total counts

-

E. coli

-

Salmonella,

-

Staphyloccocus

-

Listeria

Enterococcaceae
Storing conditions
Durability
Consumers assignment
Label

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Preparing technology flow charts

All production steps should be listed one by one
Apply proper symbols
Number steps

Symbols

Process step

Product, byproduct, raw material, additive, side product, drop off, supporting material

Measurement

Decision

Adjustment or process follow -up

Document, instruction, procedure, norm

Bond

End step of process, assignment

Follow-up treatment

Basic rules for preparing flow charts

Symbols have to be fixed in vertical columns
Main process should be fixed shorter to left side. Right side left for additions
Avoid crossing lines
Enumerate steps, pages
Apply A4 paper format

Flow chart verification

In individual plant on individual technology line
Consider former and next steps
Include each technology event – brakes, stops,

FOOD SAFETY HAZARDS CATEGORIES

Biological – microbiological

Bacteria – Salmonella, Staphylococcus, viruses, prions, moulds, yeasts, worms,

Chemical

Heavy metals, pesticides, disinfectants, antibiotic, preservatives, toxins,

Physical

Glass, jewelry, fabric, concrete, bricks, watches

Physical hazards

Cleaning tools

foam particles, mops, plastic, fabric

Machine and devices

metal particles – fillings, rubber, paints,

Air

dust,

Packaging materials

paper, plastic, wood, wires,

Staff

cigarette ends, chewing gum, jewelry, ball pens,

Animals,

Fur, pests and insects, feces, eggs,

Water,

sludge,

Surroundings

plaster, stones, sand, glass, rust,

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Chemical hazards

Residues of veterinary treatments

hormones, antibiotics

Industrial and agricultural contaminants

nitrates, heave metals, radioactive elements,

Toxins

bacterial, fungi,

Establishing critical limit for identified CCP
Establishing monitoring methods for CCP
Establishing revising operations when CCP is beyond control
Preparing quality control loop for established CCP

-

on the base of monitor sheet

-

considering appropriate symbols

Hazard analysis and establishing way to take control on identified hazards

-

each step of process must be analyzed considering chemical, physical and biological
hazards

-

apply team techniques to solve problem (ie. Brain storm)

-

to take control other means could be used: general procedures, control means

Establishing list of all hazards

Evaluation of all hazards
Preparing list of all preventive actions on each steps of process

Hazards priority defining

1. Defining frequency of hazard appearance [A]

frequency appearance [A]

high

A = 3

medium

A = 2

low

A = 1

2. Establishing priority index – risk hazard (probability of hazard appearance) [B]

priority index [B]

high

B = 3

medium

B = 2

low

B = 1

PRIORITY

P = A * B

READING

P > 3 – There is necessity to look for in production cycle step in which individual hazards could be

under constant control = establishing CCP

P < 3 – It is enough to apply preventive actions and eventually establishing CP (control point)

Result analysis

Establishing preventive actions and means

Do its exist?

Are its enough to prevent?

In case of lack preventive means for hazard it should be consider process changing

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Task after “brain storm”. Where to look for next hazards?

In:

- reclamation book
- revulsion book
- complaint book
- minutes of internal control

Establishing CCPs

CCP – the most trouble spots in production process (considering food safety)

ATTENTION
Not each CP is CCP
Not each Control Point is Critical Control Point

Ways:

-

using decision tree

-

using own experience and nous

All sideway processes must be considered
Not all steps should be controlled
ATTENTION

Hazard ≠ CCP

CCP decision tree

CCP Monitoring

Recording monitoring results
Recording made up revising operations
Signature responsible person

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CCP Monitoring

Basic requirements

When?
What?
Who?
How?
How often?
What record?
Measures:
-

physical

-

chemical

-

sensory

Applied methods have to deliver objective information

Exceeding critical limits in CCP

CCP beyond control

Return CCP to control

Utilizing produced during lose of CCP control

temperature, time, pH, flow, pressure,

humidity, concentration, staff habits

Restrain goods

- destroying item incompatible with demands
- dispose after price reducing
- repeat process
- destine for feedstuff
- treat as product fulfilled requirements

Process verification

Special tests
Microbiology tests
Market research
Consumers opinions
Internal audits
Verification processes records
-

testing

-

checking up

-

evaluation

o

with established frequency

o

regularly

o

according to instruction

HACCP system evaluation

Plans undergo constant improvement
System always is not closed – final
Plan is prepared by many years
Whichever change or modification automatically causes necessity to built new plan

HACCP Book

example

Content:

11

Title
Distributor
List of content
Preface
HACCP policy
Definitions and abbreviations
Structure of documents
Scope of HACCP system
Plan of plan – division
Characteristics of products
Flow charts
HACCP data sheets – hazards and CCP identifications
HACCP data sheets – monitor and correction actions

Documentation structure

HACCP documents:

Basic

HACCP book
Systemic Procedure Book
Company GMP/GHP Codex
Records

Supplementary

Technique-technology documentation
Cleaning and Disinfection Book
Pest and Rat Control Book
Specifications and Certifications Book
Stand instructions
Records

HACCP documentation hierarchy

1. HACCP book
2. Systemic Procedure Book, Company GMP/GHP Codex
3. Technique-technology documentation, Cleaning and Disinfection Book, Pest and Rat Control

Book, Specifications and Certifications Book

4. Stand instructions
5. Records

Restraints in HACCP implementation

Lack of understanding
Unwillingness to changes

Lack of time
Lack of means
Insufficient of training
Moving for future
Magnifying difficulties

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Measure

Establishing

actions

Follow up

Record

of results

Action record

Instruction

Preparing

instruction

Standards,

tolerances

Step

Step

(control point)

OK ?

Next step

Quality control loop

Process in control

Process in control

Failure to meet a critical limit

Loss of control