Mancuso Controls Ion and Risk CL

OFFICIAL CONTROLS ON
FOODSTUFFS:
PREPARATION OF NATIONAL
CONTROL PLANS
Alberto Mancuso
Bucharest, 30 March 2006
1
Alberto Mancuso – Official control
OBJECTIVES
OBJECTIVES OF
OF THE
THE SEMINAR
SEMINAR
• To present the basic criteria of a National

Control Plan on food safety
• To draft a roadmap for the preparation of
guidelines on official controls
• To present a tool for risk classification of food
establishments
• To present an example of check-list for own-
check assessment
2
OFFICIAL CONTROL PLANS:
OBJECTIVES AND LEGAL
FRAMEWORK
3
REG.
REG. 882/04:
882/04: PURPOSE
PURPOSE
To establish general rules for official control
 Harmonised framework of general rules

 It establishes basic criteria that Member States
shall take in consideration for the organisation of
official control
 No specific criteria is included
4
REGULATION
REGULATION 882/04:
882/04: MAIN
MAIN PRINCIPLES
PRINCIPLES
• Official controls carried out using appropriate
techniques
• Necessity that CAs take decisions in a uniform way
• Frequency: regular and proportionate to the risk
• Official controls: on the basis of documented

procedures
• Where different control units are involved: coordination
• Multiannual national control plans 5

REG.
REG. 882/04
882/04 and
and OFFICIAL
OFFICIAL CONTROL
CONTROL
1. General obligations
2. Operational criteria
3. Methods and techniques
4. Verification procedures
5. Reporting
6
REGULATION
REGULATION N.
N. 882/2004
882/2004
1 GENERAL OBLIGATIONS
• regularly
Official
controls shall
be carried • on a risk basis
out
• with appropriate frequency
7
REGULATION
REGULATION N.
N. 882/2004
882/2004
1 GENERAL OBLIGATIONS
Official controls shall be carried out taking account of
(a) identified risks

(b) FBOs’ past record
(c) reliability of any own checks
(d) Previous non compliance
8
OFFICIAL
OFFICIAL CONTROL
CONTROL and
and REG.
REG. 882/04
882/04
2 OPERATIONAL CRITERIA
• Transparency
• Impartiality
• Independence (no conflict of interest)
• Effectiveness and appropriateness
• Quality and consistency
9
OFFICIAL
OFFICIAL CONTROL
CONTROL and
and REG.
REG. 882/04
882/04
TRANSPARENCY
control activities and their

The public shall effectiveness
have access to in case of risk: nature of the
information on risk, food or feed, measures
which are taken
10
OFFICIAL
OFFICIAL CONTROL
CONTROL and
and REG.
REG. 882/04
882/04
IMPARTIALITY • Documented Procedures

• Planning on the basis of objective
data
QUALITY
• Competence (training)
• Organisation/Command chain
EFFECTIVENESS • Audit
11
REGULATION
REGULATION N.
N. 882/2004
882/2004
3 METHODS AND TECNIQUES
• monitoring
• surveillance
• verification
• audit
• inspection
• sampling and analysis
12
VERIFICATION
Checking, by examination and the consideration of

objective evidence, whether specified requirements
have been fulfilled
Example: Competent Authorities verify that Reg. 882/04

goals are achieved, through audit
13
AUDIT
It is a verification tool
Systematic and independent examination to

determine whether activities and related results
comply with planned arrangements and whether
these arrangements are implemented effectively
and are suitable to achieve objectives
14
AUDIT
examples
• Competent authorities shall carry out internal audits or may
have external audits carried out, and shall take appropriate
measures in the light of their results, to ensure that they are
achieving the objectives
• Commission experts carry out audits in Member States, in

order to verify that official controls take place in accordance
with the national control plans and in compliance with
Community law
15
INSPECTION
Examination of any aspect of feed, food, animal

health and animal welfare in order to verify that
such aspects comply with the legal requirements
16
AUDIT
AUDIT VERSUS
VERSUS INSPECTION
INSPECTION
CLASSIC INSPECTION: verification of infrastructure,

good manufacturing practices, end products
The Food Hygiene Package changes the approach of

inspectors
The necessity to carry out audit is a result of the new

approach of EU regulation on food safety
AUDITS of the Food Safety System (OWN-

CHECK)
17
DIFFERENT TYPES OF AUDITS
• By staff of the establishment: INTERNAL AUDIT
• By customers: CUSTOMERS AUDIT
• By certifying organisms: CERTIFICATION AUDIT
• By inspection services: FOOD SAFETY SYSTEM

AUDIT = OWN-CHECK AUDIT
18
OFFICIAL
OFFICIAL CONTROL
CONTROL
AUDIT
AUDIT VERSUS
VERSUS INSPECTION
INSPECTION
• Inspection is unannounced, audit is announced
• Audit is aimed at continuous improvement
• Inspection’s main goal: verify compliance with

legal requirements
Audit can be carried out only if the food business

operator has in place a food safety system
19
SAMPLING
SAMPLING ACTIVITY
ACTIVITY
• Carried out by the State

Official control
• Paid by the State (unless in case of
non-compliance)
• Carried out by the FBO/consultants

Own-check
• Paid by the FBO
• Carried out by the State

Research
• Paid by the State
20
SAMPLING
SAMPLING ACTIVITY
ACTIVITY
Action in case of non-compliance

Official control
shall be taken by CA
Own-check Action in case of non-compliance

shall be taken by FBO
No action in case of non-compliance

Research
(unless in case of unsafe food)
21
SAMPLING
SAMPLING ACTIVITY
ACTIVITY
• Specific procedures shall be followed

Official control
• Guarantees shall be provided to the
FBO (possibility to assist to analysis)
Own-check Under the responsibility of FBO
• Specific procedures shall be followed

Research • No particular guarantee shall be
provided to the FBO
22
SAMPLING
SAMPLING ACTIVITY
ACTIVITY
• In case of suspect, or
Official control • According to the National monitoring
plan
Own-check According to the HACCP plan of the FBO
Research According to a National Research Plan
23
REGULATION
REGULATION N.
N. 882/2004
882/2004
4 Control procedures and guidelines
Official controls should take place on the basis

of documented procedures so as to ensure that
these controls are carried out uniformly and are
of consistent high quality
information and instructions for

procedures
staff performing official controls
24
5 OFFICIAL
OFFICIAL CONTROL:
CONTROL: REPORTING
REPORTING
• a description of the purpose of the official controls

• the control methods applied
Includes
Includes
• the results of the official controls
• action that the FBO concerned is to take
A record-keeping system allows to prove official

controls’ activity carried out and enables to
gather uniform data on relevant results
25
PREPARATION OF A
NATIONAL CONTROL PLAN
26
REG.N.
REG.N. 882/2004
882/2004 NATIONAL CONTROL PLAN
Each Member State shall prepare a multi annual national

control plan, containing information on
• strategic objectives (prioritisation of controls)
• risk categorisation of the activities concerned
• designation of competent authorities, tasks and resources
• general organisation and management of official controls
• control systems applied to different sectors and coordination
• methods to ensure compliance with the operational criteria
• training of staff performing official controls
• documented procedures
27
OFFICIAL
OFFICIAL CONTROL
CONTROL PLANNING
PLANNING
BASIC CRITERIA
1. Each inspection shall be documented

2. Control’s frequency (average) shall be
established
3. Controls shall be prioritised (Risk categorisation
of establishments)
Check list and templates for official control shall be

developed and implemented
28
OFFICIAL
OFFICIAL CONTROLS:
CONTROLS: PROGRAMMING
PROGRAMMING
A. ACTIVITIES TO BE CONTROLLED
B. TYPE OF CONTROL
C. CONTROL PROCEDURES
D. RISK CLASSIFICATION OF THE ESTABLISHMENTS
E. PROGRAMMING ACTIVITIES
F. ACTIVITY’S RECORD-KEEPING
G. ACTIVITY’S VERIFICATION
H. REPROGRAMMING
29
A:
A: LIST
LIST ACTIVITIES
ACTIVITIES TO
TO BE
BE CONTROLLED
CONTROLLED
Information Management System
• Registered and approved establishments shall

be included in a Dbase
• Establish information’s flow
• Keep updated data on official controls
• Communicate data at central level
• Aggregate data
• Analyse data in order to reprogram activity
30
B:
B: TYPE
TYPE OF
OF CONTROL
CONTROL
AUDIT INSPECTION
Food safety system • premises, surroundings,
that FBOs have put equipment, transport
in place:
• raw materials, ingredients
prerequisites,
HACCP • semi‐finished products
• materials intended to come
into contact with food
• cleaning and maintenance
products and processes
• labelling, presentation
31
C:
C: CONTROL
CONTROL PROCEDURES
PROCEDURES
For each control shall be established the control
procedure
• hygienic condition of premises, equipment,

Visual employees, maintenance, flows, employees’
inspection behaviour
Documentary • trade documents

check • monitoring records, HACCP documentation
Measurements • temperature, pH, Aw, etc.
Analysis • sampling
32
D:
D: RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
HOW?
Development of an objective tool to classify food

establishments according to the risk, useful to
increase or decrease control’s frequency on the basis
of uniform criteria
Food industries with the same risk are

Final goal controlled in a homogeneous way
33
E:
E: PROGRAMMING
PROGRAMMING ACTIVITIES
ACTIVITIES
• A control’s program shall be established for each

plant, including type and frequency of the controls
to be carried out
• Take in consideration available resources
• Based on the risk classification
34
F:
F: RECORD-KEEPING
RECORD-KEEPING
Official controls can be recorded by
• Official controls’ record book
• Check list
• Inspection forms
• Sampling activity
• Fines
35
G:
G: ACTIVITY’S
ACTIVITY’S VERIFICATION
VERIFICATION
• That program is respected

In order to
verify • Results of controls
• Effectiveness of adopted measures
Verification is carried out revising documentation and

performing on-site visits in the plants
36
H:
H: ACTIVITY’S
ACTIVITY’S REPROGRAMMING
REPROGRAMMING
Based on the outcomes of verification, controls

program can be adjusted
At plant level, • when there are substantial changes in

program shall be production, premises, equipments
changed… • when serious non-compliance occurs
37
WHAT
WHAT HAS
HAS TO
TO BE
BE DONE…
DONE…
• National control plan
• Guidelines on official control (prioritisation,

reporting, frequency of inspections)
• Documentation: Check lists and templates
• Guidelines on own check and HACCP assessment
• Procedures to carry out official controls
• Training of inspector: on official control techniques,

HACCP, food safety legislation, audit
38
GUIDELINES
GUIDELINES ON
ON OFFICIAL
OFFICIAL CONTROL
CONTROL
OBJECTIVES
OBJECTIVES
 adoption of a system for official control programming,
in order to guarantee a uniform controls’ level
 guarantee official controls uniformity: preparation of
documented procedures, forms and check lists
 establishment of a risk-based system for official
controls prioritization
 establishment of a record-keeping and reporting
system
39
PROPOSAL
PROPOSAL
• Appointment of a Working Group
• Preparation of guidelines on official controls, including
• documented procedures, forms and check lists (on the
basis of Food Hygiene Package provisions) to be used
in official control activities
• a risk-based system for official controls prioritization
• a record-keeping system and of a reporting system
adoption of a system for official control programming, in

order to guarantee a minimum uniform frequency of controls
on the whole territory of Romania
40
PROPOSAL
PROPOSAL
NATIONAL CONTROL PLAN PREPARATION - STEPS
1. Review of the database of establishments subject

to official control
2. Instructions for official controls
 Definition of methods and techniques:
inspection of premises, equipment, etc
audit on GMP, GHP
audit on HACCP based procedures
 Definition of control procedures
 Establishment of documentation (check-lists)
41
NATIONAL CONTROL PLAN PREPARATION - STEPS
3. Definition on a control frequency, on average, for

each type of establishment
4. Establishment of a tool for risk classification
5. Pilot-testing of the developed tools
6. Review of the tool on the basis of the results
7. Programming controls on the basis of risk
classification
8. Training of Inspectors on the established system
9. Verification on official controls activities
10.Reprogramming of official controls
42
11.Definition of a reporting system
ANY QUESTIONS?
E-mail
E-mail alberto.mancuso@mps.hr
43
PRESENTATION OF A TOOL
FOR RISK CLASSIFICATION OF
FOOD ESTABLISHMENTS
Alberto Mancuso
Bucharest, 30 March 2006
44
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF FOOD
FOOD INDUSTRIES
INDUSTRIES
Premises must be rated in a scheme of priority
classification
• In few cases a system for risk classification of food

businesses has been officially developed.
• In Regione Piemonte it has been developed an objective
tool for risk classification of food businesses.
• This tool is in place since 2004 and official controls are
prioritised according to the risk classification obtained.
• This tool will be used with a view to the more efficient use
of staff resources within the constraints of the available
budget.
45
OFFICIAL
OFFICIAL CONTROL:
CONTROL: PRIORITIES
PRIORITIES
DEFINITION
DEFINITION
GOALS OF THE DOCUMENT

to develop a tool to classify food establishments according to
the risk, at the aim to make available an objective tool, useful to
increase or decrease control’s frequency on the basis of
uniform criteria
Food industries with the same risk are

Final goal controlled in a homogeneous way
46
RISK
RISK EVALUATION
EVALUATION IN
IN CONTROL
CONTROL
REGULATIONS
REGULATIONS
Nature and frequency of controls is to be based

on RISK: evaluation of risk
• It is not the same as the step of RISK ANALISYS
• It will be based on experience, data, records
• It will result in a qualitative categorization (low,

intermediate, high..)
47
OFFICIAL
OFFICIAL CONTROL:
CONTROL: PRIORITIES
PRIORITIES
DEFINITION
DEFINITION
Two steps should be foreseen for the

establishment of control’s frequencies
11 Type of production and control’s frequency
22 Risk classification of food industries
48
TYPE
TYPE OF
OF PRODUCTION
PRODUCTION AND
AND
A
A CONTROL’S
CONTROL’S FREQUENCY
FREQUENCY
This is the first criteria to address official controls’

frequency
• An average frequency of controls is established on

the basis of the type of production
• Risk profile are not depending on food safety
system established by each FBO and are not
connected with past history of non compliance
49
Type of production and control’s frequency
retail 1 control/18
months
DISTRIBUTION
Large supermarket 2 control/year
Small/medium 1 control/year
PRODUCTION 2 control/year
Large
Schools, hospitals etc. 2 control/year

CATERING
Restaurants, cafeteria etc 1 control/18 months
50
B
B RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
• Subsequently, each establishment should be taken

in consideration separately, taking in consideration
specific aspects
• Controls frequency is therefore established for each
establishment
51
B
B RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
Evaluation criteria
• Premises
11 criteria have
• Scale of the operation
been taken in
• Product
consideration,
• Hygiene
grouped in 6
• Own check
categories • Past record (non compliance)
Four different scores have been foreseen for each criteria;
a specific score is assigned for each establishment 52
CRITERIA FOR THE EVALUATION OF RISK OF ESTABLISHMENTS OF ANIMAL ORIGIN PRODUCTS:
Category Evaluation Criteria Evaluation

1 Date of building or last restore new: 0 recent restoring: medium: 20 old: 30
Features of 10
establishments
2 General conditions and good: 0 average: 20 poor: 40 Not sufficient: 70
mantening
3 Level of production Familiar: 0 Artisanal: 15 Industrial small: Industrial large: 50

Dimension of 30
production 4 Market Local: 0 Regional: 15 National: 30 International: 50
5 Category of food* A: 0 B: 15 C: 30 D: 50
Products
6 Use To be cooked Food B, C, D Specifi use
before use: 15 ready to eat: 30 (medical, infant): 50
7 Quality of management and High: 0 average: 15 low: 30 Not sufficient: 50

Hygiene inclination in term of
cooperation with CA
8 Level of training and expertise High: 0 average: 15 poor: 30 Not sufficient: 50

of staff
9 HACCP plan complete: 0 Quite good: 5 To be improved: Inadequate: 25

Own checks 15
10 Level of compliance Good: 0 Minor non Major non Not implemented:
compliances: 25 compliances: 45 75
Records 11 Previous non compliances Minor/formal/ Minor/formal/ Major/substanti Major/substantial/
53
sporadic: 0 frequent: 30
al/corrected: 60 not corrected: 100
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
Category Element Reason/explanation

Premises Building date, main General condition and maintenance are assessed
renovation taking in consideration the possibility that non
General conditions, compliances have direct effect on food safety.
maintenance Building date is considered but has low influence on
the final score.
Scale of Scale of the These components are indicators of the number and
the operation spread of population potentially exposed to a food
operation Market’s extent hazard. The business size has been used to
approximate the size of the exposed population and
therefore as an indicator of risk severity.
Type of Perishability As above stated, the frequency of inspection is
food Intended use, already based on the type of operation; nevertheless,
consumers within each type of operation the risk posed to the
population ranges according to the perishability of the
food and the intended use. In case of different
productions, the highest score is taken in
consideration.
54
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
Category Element Reason/explanation
Production Management’s Capacity and disposition to solve problems are a
expertise and demonstration of the management’s commitment; this
disposition to adopt is a key aspects in ensuring that an effective food
corrective action in safety system is implemented in a plant.
case of deficiency
Employee’s It has been taken in consideration above all the
training level on employee’s disposition to apply in practical activity the
hygiene theoretic knowledge.
Own Completeness An effective own check plan based on an adequate
check Application, application of prerequisites and Haccp principles is
system adequacy the pillar of any food safety system. In the score’s
assignment, more importance is given to the practical
implementation. Seriousness of non compliance is
bounded to the possibility of a direct effect on food
safety.
Past Irregularities and The score’s assignment is based on seriousness of
record non compliance the non compliance (possibility to have direct effect on
recorded in the food safety) and on the trend.
past
55
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
For each category, the total of the obtained score

must be multiplied by a specific value, identifying
the importance of the category (correction index)
Category X value
Premises 0,10
A Ms Excel sheet has Scale of the operation 0,10
been developed to Products 0,18
perform automatically Production 0,20
all these calculations Own check system 0,22
Past record 0,20
Total 1,00
56
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
57
RISK
RISK CATEGORIES
CATEGORIES
At the end of the • < 30: low risk

evaluation process,
each establishment
get a score and an • 30 - 42: medium risk
allocation in one of
the three identified
risk categories • > 42: high risk
• The most important factors were considered those related to
own check plan implementation and past non compliance
• Less importance has been assigned to premises
58
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
• Risk classification must be based on objective

criteria
• It is necessary to carry out an inspection/audit in
the establishment
• Take in consideration also documentation
• The word “risk” doesn’t necessarily mean a
negative evaluation
• A criteria can influence another criteria
59
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
• Specific guidelines shall be provided to local services, at the

aim to facilitate the evaluation’s process
• For each element: parameters that shall be taken in
consideration to give an objective score are to be specified
• Regarding score’s assignment:
consider if non compliances could cause food direct

contamination and therefore a direct effect on food safety;
take in consideration the trend (repeated non compliance)
A new classification can be done at any moment, depending

on changes of the situation
60
FINAL
FINAL SETTING
SETTING OF
OF FREQUENCY:
FREQUENCY: AUDIT
AUDIT
every x months
High risk Medium risk Low risk
Retail 9 18 24
Large supermarket 3 6 12
Catering: School, hospital 3 6 12

Catering: Restaurant, cafeteria 9 18 24
Production: handcraft 6 12 24
Production: industrial 3 6 12
61
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
Regione Piemonte - Results (31/12/04)
Low risk Medium risk High risk

Total
N. % N. % N. %
Abattoirs and Industrial 17 12,1 93 66,4 30 21,4 140
cutting plants Low capacity 143 48,0 136 45,6 19 6,4 298
Industrial 23 35,4 35 53,8 7 10,8 65
Meat products
Low capacity 84 45,9 85 46,4 14 7,7 183
Industrial 92 42,6 95 44,0 29 13,4 216
Milk products
Low capacity 165 56,1 104 35,4 25 8,5 294
Fishery products 22 48,9 18 40,0 5 11,1 45
Minced meat preparation 1 5,3 13 68,4 5 26,3 19
Honey 70 100 0 0 0 0 70
Eggproducts 2 33,3 2 33,3 2 33,3 6
Other 7 53,8 5 38,5 1 7,7 13
62
Total Alberto Mancuso –626 46,4
Official control 586 43,4 137 10,2 1349
Regione
Regione Piemonte
Piemonte -- Results
Results (31/12/04)
(31/12/04)
High
High risk
risk
Medium
Medium risk
risk
Low
Low risk
risk
63
RISK
RISK CLASSIFICATION
CLASSIFICATION OF
OF ESTABLISHMENTS
ESTABLISHMENTS
• Official control of food establishments is prioritised in

accordance with this risk categorisation
• Control’s frequency is based on the type of business and on
assigned risk
• The so obtained risk classification is particularly useful to
direct official control’s activity, avoiding waste of resources
and improving control’s effectiveness
• Furthermore, all data are collected and computerised at
national level
• National supervision is therefore prioritised on the basis of
unbiased data
64
CHECK
CHECK LISTS:
LISTS:
A
A PRACTICAL
PRACTICAL EXAMPLE
EXAMPLE
65
OFFICIAL
OFFICIAL CONTROL
CONTROL AND
AND DOCUMENTATION:
DOCUMENTATION:
CHECK
CHECK LISTS
LISTS
• To facilitate consistency, government agencies

should coordinate the design and use of checklists
• A checklist should lists at least the minimum
requirements referred to in regulatory criteria
• Checklists should be supported by a reference
manual to guide the assessor in their application
66
CHECK-LIST
CHECK-LIST FOR
FOR ASSESSMENT
ASSESSMENT OF
OF OWN-
OWN-
CHECK
CHECK PLAN
PLAN
1. General information
2. General documentation
3. Specific documentation
• Cleaning and disinfection
• Water supply
• Pest control
• Training
• Preoperative check
• Others
4. HACCP documentation
5. Final result
67
1.
1. GENERAL
GENERAL INFORMATION
INFORMATION
Company ____________________________________________________________________________
Address______________________________________________________________________________
Proprietor/representative ________________________________________________________________
Official veterinarian Dr. _________________________________________________________________
Responsible of own check plan __________________________________________________________
N° of employees: __________________________________________N° veterinarian _______________
ACTIVITY AND PRODUCTION AMOUNT
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
GENERAL INFORMATIONS
Sewage discharge: _____________________________________________________________________
Waste disposal ________________________________________________________________________
Water supply _________________________________________________________________________
This section includes generic data • Name and address

on the Food Business. It is • Type of activity
indispensable in order to address • General information
properly the assessment • Production amount
68
2.
2. GENERAL
GENERAL DOCUMENTATION
DOCUMENTATION
GENERAL DOCUMENTATION Yes no N.A. Non compliance

/ notes
Does the plant have a written self control plan?
Does the plan identify the person with overall
responsibility? Not applicable: to cross
Organization chart and responsibility assignment
Premises and equipments are properly identified
when the assessment is not
(plan and forms)
carried out, or when it is not
Approval/authorisation
possible to carry out
The map of the establishment

should be available, with clear
Copy of the official authorisation, indication of rooms; a
and attached documentation document (in correspondence
presented for the authorisation with the map) should list
69
Alberto Mancuso – Official control rooms and equipment
3.
3. SPECIFIC
SPECIFIC DOCUMENTATION:
DOCUMENTATION: PROCEDURES
PROCEDURES
Document including aim, field of application,

responsibilities, what has to be done, which
Procedure
documentation utilizes and provides, monitoring
and recordkeeping activities, corrective actions
Each procedure shall quote the date of

Dated and
signed by the approval and dates of following revisions. The
person in signature means that the person in charge is
charge directly responsible for the supervision of the
implementation of the procedure
Assignment of It shall be quoted the name and the position in
the person in
the firm
charge
70
3.
3. SPECIFIC
SPECIFIC DOCUMENTATION:
DOCUMENTATION: PROCEDURES
PROCEDURES
Identification Critical limit: value separating acceptability from

of critical unacceptability. It shall be clearly reported in the
limits procedure
Quote the source on the basis of which critical

Deriving
from limits have been set. Relevant documentation
should be available
Corrective actions should be established

Does the
plan identify beforehand, defining: person in charge for the
corrective implementation, what has to be done, disposition
actions on affected product, record-keeping of the
adopted measures
71
CLEANING
CLEANING AND
AND DISINFECTION
DISINFECTION
CLEANING AND DISINFECTION Yes no N.A. Non compliance /
notes
Does the plant have a written sanitation plan?
Just one plan should be available, to
Dated and signed by the person in charge
Available documentation be used for several procedures
Assignment of the person in charge for implementation
Plan of the building A detailed description on
Does the sanitation plan identify the establishment employee/s responsible for each
sanitation procedure? products to be used, how
Does the sanitation plan clearly identify and describe the procedures to be
conducted?
to use them, equipment,
Does the sanitation plan identify equipments and chemicals to be used? frequency etc. shall be
Does the plan identify the way the equipments and the chemicals must be used?
available
Does the sanitation plan identify the frequency of each sanitation procedure?
Are the chemicals’ technical papers updated and readily available?
Does the plant conduct verification activity (visual monitoring, swabs, etc)
according to a plan?
Technical papers should report
Does the sanitation plan identify the critical limits for verification? instruction on how to use the
Deriving from:  legislation  scientific documentation .….
product.
….
Check if available
... …... ……………………
……..
technical
Have been established corrective actions to carry out in case of non compliance? papers are consistent with the
Documentation on employees specific training
products used in the plant
Procedure for preoperational and operational checks
Including checks on hygiene of premises and equipment
Training should be carried out to provide employees information on how 72
to
Including checks on hygiene of the staff and clothes
carry
Documentation is correctly updated out cleaning
and filed and
Alberto Mancuso disinfection
– Official control activities
CLEANING
CLEANING AND
AND DISINFECTION
DISINFECTION
CLEANING AND DISINFECTION
A verification plan should
Yes no N.A.
be available,
Non compliance /
notes
Does the plant have a written sanitation plan? including what has to be verified, how
Available documentation
and when, person in charge
Plan of the building
A preoperative check is carried out,
before to start the operation, in
Does the sanitation plan identify the establishment employee/s responsible for each
sanitation procedure?
Does the sanitation plan clearly identify and describe the procedures to be
order to assess that hygienic
conducted?
condition are suitable. This is
Does the sanitation plan identify equipments and chemicals to be used?
Does the plan identify the way the equipments and the chemicals must be used? indispensable when more than one
Does the sanitation plan identify the frequency of each sanitation procedure? person is in charge to carry out
Are the chemicals’ technical papers updated and readily available?
cleaning and disinfection. Particular
Does the plant conduct verification activity (visual monitoring, swabs, etc)
according to a plan? attention should be dedicated to
Does the sanitation plan identify the critical limits for verification?
surfaces that come in direct contact
Deriving from:  legislation  scientific documentation .…. …. ... …... ……………………
with food
……..
Have been established corrective actions to carry out in case of non compliance?
Documentation on employees specific training
Procedure for preoperational and operational checks
Including checks on hygiene of premises and equipment
Including checks on hygiene of the staff and clothes 73
Documentation is correctly updated and filed Alberto Mancuso – Official control
WATER
WATER SUPPLY
SUPPLY Including: type of source,
WATER SUPPLY internal
Yes water
no N.A. supply description,
Non compliance /
notes
A procedure is available
water tanks, controls to be
Dated and signed by the person in charge of the procedure carried out (to be decided
according to the situation)
In case of public water supply: copy of the contract Assess data on consumption. It
Plan of the building reporting water outlets
Internal water supply scheme
is important to check if there are
Does the plant regularly test water to be used? other sources
Are analysis adequate?
critical limits have been established
Deriving from:  legislation  scientific documentation .… …. ….. …... ……………………..
Does the plant identify procedures to be performed in case of irregular water analysis data?
In case the plant has an intermediate water tank, does it conduct inspection, cleaning and
maintaining procedures?
Does the plant identify a procedure to be conducted to inspect, clean and maintain water filters,
if present?
In case of water coming from the well
Technical description of the well
Is the water chlorinated or otherwise potabilized?
On the map, water outlets should be identified and….numbered
If yes, describe …………………………………………………………….. (important for
….. …... ………………………
…..
sampling plan). Furthermore, internal
Does the plant have written procedures to manage and verify water potabilization?
water supply scheme should be
available,
Assignment of the to assess
person in charge of possible situation at risk (proximity with sewage discharge
the disinfection system
74
Documentation is correctly updated and filed
system)
WATER
WATER SUPPLY
SUPPLY
WATER SUPPLY
AYes
sampling
no N.A.
plannotesshould be
Non compliance /
A procedure is available available, detailing: where to

Dated and signed by the person in charge of the procedure
sample, how, analyses to be
Available documentation carried out, when samples have
In case of public water supply: copy of the contract
to be taken
Plan of the building reporting water outlets
Internal water supply scheme
Evaluate on the basis of the
Does the plant regularly test water to be used?
Are analysis adequate? situation: public supply,
critical limits have been established water from the well, tanks,
Deriving from:  legislation  scientific documentation .… …. ….. …... ……………………..
Does the plant identify procedures to be performed in case of irregular water analysis data? possible previous non-
In case the plant has an intermediate water tank, does it conduct inspection, cleaning and compliance, situation at risk
maintaining procedures?
Does the plant identify a procedure to be conducted to inspect, clean and maintain water filters,
if present?
If yes, describe …………………………………………………………….. …. ….. …... ………………………
…..
Corrective actions adequacy should be evaluated on the basis of the non
compliance
Assignment of the person in(i.e. severe
charge of actions
the disinfection system have to be taken in case of pathogens
Documentation is correctly updated and filed 75
Alberto presence)
Mancuso – Official control
WATER
WATER SUPPLY
SUPPLY
A document describing
in details well’s
characteristics should be
available
If yes, describe …………………………………………………………….. …. ….. …... ………
Assignment of the person in charge of the disinfection system
A detailed description of interventions carried out in order to obtain potable

water should be available. Moreover, the following documentation should be
available: technical documentation on disinfection equipment, description of
alarm systems, a report on treatment efficacy on the basis of water
76
consumption and contact
Alberto Mancuso – Official control period
PEST
PEST AND
AND RODENT
RODENT A description on measures
CONTROL adopted to prevent pests’
CONTROL harboring should be included
PEST AND RODENT CONTROL Yes no N.A. No
Contract should include: n° of
Does the plant have a written pest control plan?
intervention, type of operation
carried out, actions to be taken in
case of non-compliance
Are the pest control procedures performed by an approved company? Does the plant have a
written contract with the external company?
In case the plant is self-managing pest control procedures, is there a list of trained employee/s?
Does the plan identify the employee/s responsible for the procedures?
Does the pest control plan clearly identify and describe procedures to be conducted? Traps and baits shall
Does the pest control plan identify the frequency of procedures? be indicated and
Is there an updated map of the facility showing location of all traps? numbered on the
Are the baits’ technical papers updated and readily available? map
Does the plan identify corrective actions to carry out in case of non compliance?
Critical limits should be established, and corrective actions in case of 77non

compliance should be specified
PERSONAL
PERSONAL HYGIENE
HYGIENE --
TRAINING
TRAINING Companies should have in
place a policy concerning
employees’ health status
PERSONAL HYGIENE Yes no N.A. Non compliance /
notes
Does the company verify employees’ health certificates before their admittance to work?
A regulation on clothes used by employees is available
In the regulation are defined
clothes allowed in working areas
Clothes and personal object not allowed in working areas
Changing Frequency of clothes
Training program should provide
Person in charge for cleaning clothes
Cleaning procedure details on sessions addressed to
How and where dirt and clean clothes are stored employees (date, issues,
TRAINING
trainers, Yes no N.A. Non compliance /
trainees), verification
notes
Does the plant have an employees’ training program? activities, updating, goals
Does the training program address good hygiene requirements and good manufacturing practices?
Does the plant verify employees’ learning?
Had the Official Veterinary Service been involved in the training program?
Training’s effectiveness should be assessed, through final tests or evaluating

employees’ behaviour during operative checks (compliance with Operating 78
procedure established by the management). Critical limits should be established
SUPPLIERS
SUPPLIERS AND
AND RAW
RAW Procedure should include a
program of analysis and of
MATERIAL
MATERIAL acceptance checks (frequency,
type, responsibility)
Data on suppliers should be

available, together with
SUPPLIERS AND RAW MATERIAL Yes no N.A. Non complianc
products description, notes
A procedure is available acceptance checks to be
Dated and signed by the person in charge of the procedure
carried out, specific
Assignment of the person in charge for implementation requirements
Record keeping: Suppliers and raw materials
Letters of guarantee from the suppliers
Suppliers should provide a
Documentation on audits perfomed written acceptance of general
corrective actions to carry out in case of non compliance and specific requirements,
Test results of the analysis performed by the supplier
according to customer’s need
Schedule of acceptance are filled, dated and signed
It is important that corrective actions to undertake in case of non compliance

79
with specified requirements are–detailed,
Alberto Mancuso Official control and adopted if necessary
TEMPERATURE
TEMPERATURE CHECKS
CHECKS
Limits should be established for
rooms and for products
TEMPERATURE CHECKS Yes no N.A. Non
Assignment of the person in charge In case of non compliance,

critical limits have been established
corrective actions should
Deriving from:  legislation  scientific documentation .… …. ….. …... ……
specify: product’s disposition,
corrective actions to carry out in case of non compliance
An emergency procedure is available action to reestablish
Documentation is correctly updated and filed compliance, recordkeeping
Does the plant have any process-monitoring instruments calibration procedures?
Indispensable in case instruments measure temperature in correspondence of

a CCP
80
LOT
LOT IDENTIFICATION,
IDENTIFICATION, TRACEABILITY
TRACEABILITY AND
AND RECALL
RECALL
Companies producing food not intended to be directly sold to

the final consumer shall have in place this procedure. Aim: to
enable the identification of homogeneous batches
LOT IDENTIFICATION, TRACEABILITY AND RECALL Yes no N.A. Non

Procedure shall include
Does the plant have a procedure for lot identification? operative instructions on
Does the plant have a procedure to hold and to manage returned products? measures to be adopted
Does the plant have a procedure for recall?
concerning withdrawn
Including an updated customers list
products
Documentation connecting lot and customers
In order to guarantee traceability, FBOs shall establish a connection between

lots and customers
81
4.
4. HACCP
HACCP SYSTEM:
SYSTEM: DOCUMENTATION
DOCUMENTATION
HACCP Yes no N.A. Non compliance /
notes
Has a written HACCP plan been developed and implemented by the plant?
Does the HACCP plan contain a list of revisions or changes? Is the present revision correctly
identified?
Does the plan include a product description?
Does the plan include a Flow Chart Diagram for each product/process?
Did the HACCP team verify the Flow Chart on site?
The establishment has conducted, for each product/process, a hazard analysis that includes food
safety hazards likely to occur
The analysis includes the intended use of or the consumers of the finished products
All hazards identified in the analysis are included in the HACCP plan; the plan lists a CCP for
each food safety hazard identified
Have the critical limits been established?
Have the monitoring procedures been established?
Does the plan establish monitoring frequency?
Does the plan identify the staff with monitoring responsibility?
If necessary, does the plan identify the instruments to be used in monitoring procedures?
Does the plan identify records documenting monitoring activity at CCPs?
Does the plan include for each CCPs corrective actions as required?
Does the plan identify records documenting corrective actions?
The HACCP plan was validated using multiple monitoring results
The HACCP plan lists the establishment’s procedures to verify that the plan is being effectively
implemented and functioning and the frequency for these procedures
82
The HACCP plan is dated and signed by a responsibleAlberto
establishment
Mancuso official
– Official control
4.
4. HACCP
HACCP SYSTEM:
SYSTEM: RECORD-KEEPING
RECORD-KEEPING
DOCUMENTS REVIEW Yes no N.A. Non compl

notes
Are monitoring records being conducted as planned?
Are corrective actions regularly recorded?
Do documents indicate that corrective action procedures are effective?
Are laboratory’s analytical results promptly recorded?
Are sanitation monitoring results reflecting the effectiveness of procedures conducted? Are
corrective actions records regularly conducted?
Check-lists for preoperational and operational checks are correctly filled in, dated and signed
Are pests monitoring results reflecting the effectiveness of procedures conducted? Are
corrective actions records regularly conducted?
Are employees’ training activities properly documented?
Are maintenance procedures actually conducted and documented?
Is instruments calibration documented?
Are monitoring and corrective action records routinely reviewed to assess the plan’s
effectiveness and eventually to adjust it?
83
4.
4. HACCP
HACCP SYSTEM:
SYSTEM: PRACTICAL
PRACTICAL IMPLEMENTATION
IMPLEMENTATION
PLANT ON SITE VERIFICATION Yes no N.A. Non complia

notes
Is the person in charge of plan implementation aware of his role, has he sufficient authority and
autonomy to correctly perform his job?
Are monitoring procedures effectively conducted as planned?
Do employees demonstrate to perform hygienic procedures as planned and expected?
Do employees in charge of monitoring procedures perform them consistently and correctly?
Do employees have suitable and clean working outer garments?
Is there evidence that sanitation plan is conducted as expected?
Is there evidence that the maintenance plan is conducted as expected?
Are all products labeled with a lot code as indicated by traceability procedures?
Does available evidence exist that the company can trace all supplies and finished products?
84
ANY QUESTIONS?
E-mail
E-mail alberto.mancuso@mps.hr
85

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OFFICIAL CONTROLS ON

Bucharest, 30 March 2006

• To present the basic criteria of a National

OBJECTIVES AND LEGAL

To establish general rules for official control

 Harmonised framework of general rules

• Necessity that CAs take decisions in a uniform way

• Frequency: regular and proportionate to the risk

• Official controls: on the basis of documented

• Where different control units are involved: coordination

• Multiannual national control plans 5

3. Methods and techniques

Official controls shall be carried out taking account of

(a) identified risks

• Independence (no conflict of interest)

• Effectiveness and appropriateness

• Quality and consistency

control activities and their

IMPARTIALITY • Documented Procedures

3 METHODS AND TECNIQUES

Checking, by examination and the consideration of

Example: Competent Authorities verify that Reg. 882/04

Systematic and independent examination to

• Commission experts carry out audits in Member States, in

Examination of any aspect of feed, food, animal

CLASSIC INSPECTION: verification of infrastructure,

The Food Hygiene Package changes the approach of

The necessity to carry out audit is a result of the new

AUDITS of the Food Safety System (OWN-

• By staff of the establishment: INTERNAL AUDIT

• By customers: CUSTOMERS AUDIT

• By certifying organisms: CERTIFICATION AUDIT

• By inspection services: FOOD SAFETY SYSTEM

• Inspection is unannounced, audit is announced

• Audit is aimed at continuous improvement

• Inspection’s main goal: verify compliance with

Audit can be carried out only if the food business

• Carried out by the State

• Carried out by the FBO/consultants

• Carried out by the State

Action in case of non-compliance

Own-check Action in case of non-compliance

No action in case of non-compliance

• Specific procedures shall be followed

Own-check Under the responsibility of FBO

• Specific procedures shall be followed

Own-check According to the HACCP plan of the FBO

Research According to a National Research Plan

4 Control procedures and guidelines

Official controls should take place on the basis

information and instructions for

• a description of the purpose of the official controls

A record-keeping system allows to prove official

NATIONAL CONTROL PLAN

Each Member State shall prepare a multi annual national

1. Each inspection shall be documented

Check list and templates for official control shall be

D. RISK CLASSIFICATION OF THE ESTABLISHMENTS

Information Management System

• Registered and approved establishments shall

• hygienic condition of premises, equipment,

Documentary • trade documents

Measurements • temperature, pH, Aw, etc.