HACCP Ja Akkreditointi-Eng

9/10/2015 Quality management system to ensure food safety (HACCP) certification and accreditation of laboratories

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Page 1

7.12.2011

Quality system

food safety

In order to ensure (HACCP) and

Accreditation of laboratories

MICRO 575 Food

and environmental hygiene, and

surveillance

1Seija Pihlajaviita

Page 2

Guidelines and legislation

Codex Alimentarius, the International Food Standards /

international food standards

EC legislation, in particular the hygiene of foodstuffs EC

852/2004, Article Analysis and Critical Control 5 Risk

Control Points

National legislation

General Food Hygiene Regulation EC 852/2004 Annex II: All

hygiene requirements applicable to food business operators

• that you have received this Annex, the Regulation!



See. Contents.

Claims MAFDcr 37 / EEO / 2006 foodstuffs of animal origin

the hygiene of foodstuffs, in particular, annexes 15

MAFDcr 28/2009 of certain food establishments

the hygiene of foodstuffs

7.12.2011 2Seija Pihlajaviita

Page 3

HACCP guidelines

Codex Alimentarius

European Commission: Guidance document. HACCP

the implementation of procedures based on the principles of

and facilitating the implementation of HACCP principles

in certain food businesses

http://ec.europa.eu/food/food/biosafety/hygienielegislation

/guidance_doc_haccp_fi.pdf

The HACCP system, principles and application (Evira's

Help 10002/1)

Www.evira.fi


Page 4

HACCP guidelines

Food Association HACCPbased

selfregulating instructions

Www.etl.fi

A general part

Fishing industry

Vegetables and berries, industrial

Bakery Industry

Meat and convenience food industry



Milk Processing Industry

Confectionery industry

Magazine articles

Food and Health

Developing food


Page 5

7.12.2011

Danger = the food of the biological,

physical or chemical factor that may

jeopardize the safety of the food

Risk = Hazard to health caused by

the adverse impact of the likelihood and

strength

(EPNAs 178/2002 Article 3)

5Seija Pihlajaviita

Page 6

Scientific risk assessment

Risk assessment (in english. Risk assesment)

means an international scientific work

EFSA (European Food Safety Authority)

the scientific risk assessments and statements →



7.12.2011

The development of legislation

National scientific risk assessments →

national legislation, programs and guidelines

Some of the risk analysis (see following figure).

6Seija Pihlajaviita

Page 7

7.12.2011

Risk analysis(CAC Codex Alimentarius

Comission) Source: Maijala, R. 2007 work Korkeala Food Hygiene (ed.)

Risk management:

Overall Risk Assessment

Evaluation of options

Application options

Monitoring and

Reassessment

Risk assessment:

Hazard identification

Hazard characterization

Exposure assessment

Risk characterization

Rhit

message

on Colorado

7Seija Pihlajaviita

Page 8

! Practical risk assessment!

Inhouse control planning requires reliable

and systematic information on the food business operator

the dangers of a risk assessment of the production

Production facilities



7.12.2011

Identify the hazards

Assess the risks involved, and

Be able to choose the right risk management measures.

Regional State Administrative Agencies and municipal

control plans are based mostly

practical risk assessment → control

targeting, forecasting and resource

contingency situations

8Seija Pihlajaviita

Page 9

7.12.2011

The most significant food poisoning

In recent years, causes of

2004 2005 2006

1. Too slow cooking

cooling

Infected

employee

Incorrect

storage temperature

2. Insufficient

heating food

Incorrect

storage temperature

Inadequate

cooling

3. Invalid

storage temperature

Contaminated raw

substance

Inadequate

heating

Source: Food poisonings in Finland reports, Evira

9Seija Pihlajaviita

Page 10

Selfcontrol and risk management

The legislation

based on

selfcontrol →



7.12.2011

Selfassessment plan

GHP Good Hygienic

Practices Ladies

hygiene practices

GMP Good

Manufacturing Practices

Good production practices

HACCP Hazard

Analysis and Critical

Control Point

10Seija Pihlajaviita

Page 11

7.12.2011

Food safety and

Quality systems

GMP, GHP, ie GoodProduction andhygiene practices

HACCP

Quality management system, for example. ISO 9000,ISO 22000

Quality Management, TQM

Support ProgramsPRSPs,selfmonitoringfoundation

Selfassessment plan


Page 12

HACCP system and

prerequirements (support programs)



7.12.2011

HACCP

The aid scheme, or

prerequisites:

Staff

training

Food hygiene requires thatfood businesses to implement HACCP

prerequisite requirements and based on the principles

procedures

Em. The purpose of the requirements is the general risks

control


Page 13

7.12.2011

Own checks /

support system

Prerequisite programs, PRSPs

all of the HACCP system prerequisite

The systems and rules that aim at

food safety

support system consists of food hygiene

the general principles (General Principles of Food

Hygiene) based programs

Ks.HACCP system, principles and application

(Evira's instruction 10002/1) p. 67


Page 14

Prerequisites



Infrastructure and equipment requirements

Requirements for the raw materials

Safe handling of food (packaging and

transportation included)

Food Processing

Tuholaistorjuntamenettely

Sanitation procedures (cleaning and disinfection)

Water Quality

Maintaining the cold chain

Employee Health

Personal hygiene

Education


Page 15

7.12.2011

HACCP principle

H Azard A nalysis C ritical C ontrol P oints

The objective of manufacturing and processing of food

potential microbiological, chemical and related

Prevention of physical risks

applicable throughout the food processing chain

Primary production of food, industrial manufacturing, transportation,

storage, marketing, catering and large economies EVENT

cooking

Hazard Analysis assessment of risk, ie the risk of

Critical Control Points critical, or essential

management of credit

Such working or processing stage, where the risk can be seen and its

progression can be halted and to which management measures can be

target

Of vital importance of food safety threat,

in order to prevent, eliminate or reduce to an acceptable

level


Page 16



HACCP procedures

Requires a wide range of expertise to be considered

raw materials, manufactured products,

the production process, distribution chain, maintenance and

sanitation, quality control and

the hygiene of foodstuffs (microbiological, chemical and

physical hazards and their management)

HACCP group, which may also be used, if necessary,

external expertise

May also be, for example, subgroups of products HACCP.

The HACCP system functionality requires commitment and

training in the principles of the system (training will be

recorded)


Page 17

Product Descriptions

Product ...

Product Name

Features

Preparation and additives

The characteristics and origin of the raw material

Manufacturing method

Type of packaging and Supplies

Labeling

Shelf life

Storage

Distribution

and its use of the description

A user group (general consumption, or some specific group)

Operating mode




Page 18

Flowcharts

Product or group of products processing and

the preparation stages of the work

in chronological order of raw materials

the reception of the packing and distribution

Product Safetyrelevant data

Temperatures, the duration of the stages of production and residence

Transfers to another room space

Possible product retreatment

(If necessary, the room of the hygiene level)


Page 19

HACCP seven principles

1. Risk assessment

2. Determination of critical control points

3. Determination of critical limits

4. CCP monitoring practices

compilation

5. Determination of remedial measures

6. Establishment of verification process and HACCP program

Validation

7. HACCP documents and records

The principles 2 to 5 are managed by identified hazards!




Page 20

Risk assessment

a) Identify hazards that must be prevented,

eliminated or reduced to an acceptable level

(EPNAs 852/2004 of 5 art.)

Flowcharts and product descriptions underlying

Hazards identification

All manufacturing and product additives,

in packaging, labor and production phases,

storage and distribution of medicines biological,

chemical and physical hazards

Takes into account user groups

Making use of research data, information

food poisoning, control data


Page 21

Risk assessment

Risk assessment of the probability and severity of

Use of food products and their raw materials related to

epidemiological statistics, the results of the national control programs

and scientific publications, information on selfevaluation,

customer complaints

Seriousness refers to the health risk posed by a particular hazard

degrees (the focus here is specifically detrimental health effects, no other

quality defects)

Based on the severity and the probability of deciding whether

identified a risk of significant

Control of means of identification

Identify the means by which significant risks can be managed, ie

to prevent, eliminate or reduce to an acceptable level

For example, heating, cooling, decrease in pH, or the raw material.

Requirements procurement requirements

Hazards can also be managed using the system of aid programs

(eg., hygienic working methods, production space temperature control,



labeling)


Page 22

Microbiological hazards

The microbes can cause

Food contamination

Food poisoning (intoxication, infetktiot)

Process Problems

Pollution, ie contamination

Crosscontamination

Introducing secondary


Page 23

Chemical Risks

The food natural toxins

The preparation of food processing born

toxins, for example. PAH

Mycotoxins, ie mycotoxins (can also be

The microbiological risk)

The preparation of food processing born

toxins, for example. PAH

Additives too much in metered

Environmental Toxins

Pesticide residues



Residues of veterinary medicinal

Transferred to the food package chemicals


Page 24

Physical hazards

Can contaminate the food mechanically

Foodstuffs appear to the naked eye

seen in foreign objects

Dust, dirt, mud, mold

The stones, buttons, nails, wood and metal pieces etc.

Hair, plasters, cigarette butts, etc.

Dead insects, other pests as well as their

droppings

Equipment used in the manufacture of food

detached parts, fragments etc. of the packaging material.

Other nonfood items


Page 25

Critical control points (critical

Control Point CCP) Setting

b) identify the critical control points at the step or

stages, which control is essential hazard

combat, eliminate or reduce it to

to an acceptable level (EPNAs 852: 2004 art. 5)

The starting point is always a health risk, no product

Quality features

The risk can be detected by measuring or estimating

The risk can be controlled



Halls satisfying about it to determine the critical limits

The critical limit is exceeded, the safety can be guaranteed

corrective measures


Page 26

Critical Control Point (Critical Control

Point CCP)

The Ministry of Employment and the production phase, in which food security

controlled by means of an aid scheme, should not be selected as a critical

management point

The CCP may be

The heating of the product, wherein the microbial pests harmful to

Cooling and freezing step in which microbial growth is prevented

Production phase where the safety of the product of the active

the composition is controlled (pH, aw)

Production phase, using a metal detector or

fluoroscopy

CCP can be used to determine the

decisionmaking tree (Sanco and the Codex Alimentarius)


Page 27

Determination of critical limits

c) Define the fight against the identified risks,

elimination or reduction of critical

critical limits at control points acceptable

level to separate levels, which can not be

approve (EPNAs 852: 2004 art. 5)

The minimum and maximum values within which critical

Control points of the health hazards remain well



controlled or prevented altogether

Justified and measurable


Page 28

Determination of critical limits

May be based on legislation, regulatory guidance,

literature, food, and the test reports

experts views

Critical limits can be set to a temperature period,

water content, water activities, pH,

salinity, preservatives, and the number of

Sensory characteristics

The alarm limit the upper or lower than the critical limit,

a crossing / undercutting suggests that

approached the critical limit


Page 29

Establishment of monitoring practices

d) Establish effective critical control points

procedures for monitoring and implementing

(EPNAs 852: 2004 art. 5)

Each CCP will be monitored as planned

Monitoring practices are described

What will be monitored



Monitoring Method

Monitoring Frequency

monitoring supplier

to whom be notified if a discrepancy is critical limits or

any alarm limits

how to followup are recorded

Necessary followup forms or the system CCP

automatic monitoring


Page 30

Establishment of monitoring practices

Tracking Method

The results should be made quickly, in order to appropriate corrective measures,

to take immediate In most cases chemical and physical measurements (pH,

temperature and time measurements, the use of a metal detector, fluoroscopy) Sensory evaluation

Microbiological and chemical analyzes for this purpose is often too slow

Monitoring frequency

Sufficient to establish the basis of whether the management of the CCP or not

Execution and followup measures

Record: date, time, product identification, monitoring results

In the manual followup verification of the monitoring provider

Monogrammed / signature Automatic followup monitoring to check on a regular basis (eg.

daily, batch by batch) recorded the results and records of the automatic equipmentthe date of the inspection and initials / signature

The deviations are clearly marked

Deviations indicate the person who is responsible for the corrective measures

the execution of Conducts the monitoring records their actions


Page 31

Determination of remedial measures

e) Establish corrective actions when monitoring

indicates that a critical control point is not

under control(EPNAs 852: 2004 art. 5)

the monitoring of the supplier detects a discrepancy of the critical

limits or possible alarm limits should take



corrective measures

Remedial measures shall be determined for all critical

all critical control points at the borders and

potential alarm limits

Be designated as the supplier of the remedial measures described

Recognition and developing measures used

Forms

For example, the temperature correction of pH. Adjusters,

additional cleaning measures, the functioning of equipment maintenance and

corrections in the production process


Page 32

Corrective measures should be

comprises:

1. The measures relevant to the product that are

depending on the case:

a) the continuation of processing (eg. the direct heating,

Continuation)

b) the product lot of use of (often the first

measure)

c) investigation of the hygienic quality of the batch (for all other

as the cases of a paragraph)

d) Retraction (If a consignment of products already on the market, this is an indication

the fact that the HACCP system has been betrayed)

e) The product reprocessing even when the product is still

food premises

2. Correcting the deviation so that a critical control point

will again control

3. The deviation detection and elimination of the cause

4. Prevention of a recurrence of the deviation


Page 33

Preparation and verification process

HACCP plan validation

f) Establishing procedures, which shall take

at regular intervals, ae subparagraph

the effectiveness of the measures referred to



revision(EPNAs 852: 2004 art. 5)

, Verification ensures the HACCP

effectiveness and adequacy of the system

Monitoring and records arising from the remedial measures

and summaries of inspection

Monitoring and corrective measures for persons performing

Audit activities


Page 34

Preparation and verification process


The functioning of measurement instruments used in inspection

Potential measurements made by the verifier himself

Sampling products (microbiological, chemical and

physical examinations) or sensory evaluation

Authentication is done on a regular basis the agreed schedule

in accordance with

The verification shall be carried out to a different person than the followup

Verification is documented


Page 35


Is the HACCP program drawn up correctly?



Can the implementation of a program to ensure the product

the security or whether the program need to change?

Alkuvalidointi before the introduction of the HACCP program

The reassessment annually or

You change the process, the raw materials or product

New information on possible health hazards

This product can be found pathogens

The products have caused food poisoning

The critical limits are exceeded repeatedly

Validation is done in a documented


Page 36

HACCP documents and records, as well as

their management

g) Elaborate food company size and nature

in accordance with the documents and records of the

demonstrate that referred to in subparagraph f

measures are effectively applied

HACCP documents include plans and instructions,

arising from the HACCP system preparation

and to guide the implementation of the system

HACCP records are entries and information, which

born of the implementation of the HACCP program

• Must be identifiable and traceable, and made so that they are not

can change

• HACCP records are kept for two years, and

at least 6 months than the product of the sales period


Page 37

EL 23/2006 20 §



7.12.2011

"Inhouse control should be accompanied, if necessary

sampling and analysis plan as well as

Data laboratories, where selfmonitoring

Samples to be analyzed. "

in particular, are required by law

omavalvontatutkimukset is made

approved laboratory


Page 38

7.12.2011

Classification of laboratories

Regulatory Laboratories

Accredited

Omavalvontanlaboratoriot

The examinations provided for legal acts

Other supervisory authority ordered

studies (VnA 321/2006)

Estimated for approval by Evira, the assessment

take FINAS Accreditation

Meat Inspection Bodies

VnA laboratories


Page 39

EL 23/2006 20 §



7.12.2011

"Inhouse control should be accompanied, if necessary

sampling and analysis plan as well as

Data laboratories, where selfmonitoring

Samples to be analyzed. "

in particular, are required by law

omavalvontatutkimukset is made

approved laboratory


Page 40

7.12.2011

Classification of laboratories

Regulatory Laboratories

Accredited

Omavalvontanlaboratoriot

The examinations provided for legal acts

Other supervisory authority ordered

studies (VnA 321/2006)

Estimated

Meat Inspection Bodies

Coming VnA laboratories




Page 41

Accreditation

Testing and calibration laboratories General

on the requirements of the standard SFSEN ISO / IEC

17025: 2005

MIKES Centre for Metrology and Accreditation / FINAS

Accreditation

Akkreditointikausi 4 years

Every 4th year reaccreditation

The intervals, as a rule, periodic assessments every year

Lead Auditor FINASista

Technical Reviewers tend to other laboratories

Accredited Pätevyysalueessa methods


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