BTSF

ACADEMY
Day 5 - Audit

Laureano Garcia-Munoz

Budapest, October 2023

BTS
Time Activity Objectives Method Tutor

Registration • To review participants’ expectations daily;

Warm-up
08:15 Overview of • To introduce the scope and topics of the day’s GC
exercise
the previous day session.

• To know the EU legal framework;

Audits - Introducing
• To understand the principles of auditing;
the principles of Lecture
• To gain information on how to conduct audits,
08:30 audit and inspection Group discussion: LGM
preparatory steps, on-site audit activities,
activities within the Q&A
conclusions and reporting, corrective actions and
EU legal framework
audit follow up.

• To know the quality management systems in

connection to audits;
Audits and Quality Lecture
• To understand the Auditor’s competences and
09:15 Management Group discussion: LGM
training requirements;
Systems Q&A
• To be knowledgeable on the PDCA circle,
continuous improvements and MANCPs

10:30 Coffee – break

Time Activity Objectives Method Tutor

10:30 Coffee – break

Working Group Session

related with:

• Audit criteria, evidence,

findings and conclusions
linked to the field
• To know how to set up and carry out an Audit; Group discussion
activities of the previous
• To link the audit process to the week’s training and exercise.
days LGM
10:45 activities;
• To understand how to introduce improvements in Exercise
• Improvements and PDCA
audit activities. presentation
Circle.

Presentation of group
conclusions by a
designated speaker for
each group
1.- Principles of
auditing within
the EU legal
framework
 The EU legal framework

• Official controls to ensure the verification of compliance with feed and

882/2004 (to be revoked on 14/12/2019) food law, animal health and animal welfare rules

• On Official Controls - amending and Repelling 882/2004 & 854/2004

(and others)
625/2017 (from 14/12\2019) • 2019/624 – implementing Regulation meat and live molluscs
• 2019/627 – implementing Regulation – POAO

• Hygiene of food stuffs

852/2004 • Primary production
• GHP & HACCP

ISO 19011/2018 • Guidance for managing auditing systems

ISO 9000/2015 • Principles of Quality Management

• Conduct of audits under Regulation (EC) No 882/2004 on official

Commission decision 2006/267/EC controls to verify compliance
 The EU legal framework – EC No 625/2017

Tittle I, Article 3 - Definitions

30.- “audit” means a 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

Article 7 of 882/2004 (removed in 625/2017).- “inspection” means the

examination of any aspect of feed, food, animal health and animal welfare in
order to verify that such aspect(s) comply with the legal requirements of feed
and food law and animal health and animal welfare rules;
 The EU legal framework – EC No 625/2017

• Less frequent Allows for deeper

• Un/Announced, more formalised
• Larger scale/scope
investigation and root cause
• Often system/program based analysis to identify
• Structured but allows for further systematic/process
investigation & root cause analysis
issues

• Frequent
• Unannounced
• Focused/Specific Allows for the identification
• Often equipment or area based & correction of hazards on
• More rigid, often check-list based a case by case basis
 The EU legal framework – EC No 625/2017

Tittle II, Chapter II, Section I, Article 14 – Methods and techniques for official controls

Official control methods and techniques shall include the following as appropriate:

a) an examination of the controls that operators have put in place and of the results obtained;

b) an inspection of:

i. equipment, means of transport, premises and other places under their control and their
surroundings;
ii. animals and goods, including semi-finished goods, raw materials, ingredients, processing
aids and other products used for the preparation and production of goods or for feeding
or treating animals;
iii. cleaning and maintenance products and processes;
iv. traceability, labelling, presentation, advertising and relevant packaging materials including
materials intended to come into contact with food;

c) controls on the hygiene conditions in the operators’ premises;

 The EU legal framework – EC No 625/2017

d) an assessment of procedures on good manufacturing practices, good hygiene practices,

good farming practices, and of procedures based on the principles of hazard analysis critical
control points (HACCP);

e) an examination of documents, traceability records and other records which may be relevant
to the assessment of compliance with the rules referred to in Article 1(2), including, where
appropriate, documents accompanying food, feed and any substance or material entering or
leaving an establishment;

f) interviews with operators and with their staff;

g) the verification of measurements taken by the operator and other test results;

h) sampling, analysis, diagnosis and tests;

All of the above!
i) audits of operators;

j) any other activity required to identify cases of non-compliance.

 The EU legal framework – EC No 625/2017

Recital 29 – internal audits

The competent authorities should carry out internal audits or have audits carried out on their behalf,
to ascertain compliance with this Regulation. Those audits should be carried out in a transparent
manner and be subject to independent scrutiny.

Tittle II, Chapter I, Article 6 – Competent authorities

1.To ensure their compliance with this Regulation, the competent authorities shall carry
out internal audits or have audits carried out on themselves and shall take
appropriate measures in the light of the results of those audits.

2.The audits referred to in paragraph 1 shall be subject to independent scrutiny and

carried out in a transparent manner.
 The EU legal framework – EC No 625/2017

Recital 76 – Multi-annual control plan (MANCP)

Each Member State should be required to set up and regularly update a multi-annual
national control plan (MANCP) covering all the areas governed by Union agri-food
chain legislation and containing information on the structure and organisation of its
system of official controls.

Such MANCPs are the instrument through which each Member State should ensure that
official controls are performed in a manner that is risk-based and efficient across
their territory and across the entire agri-food chain, and in compliance with this
Regulation. Appropriate consultation with relevant stakeholders in advance of the
preparation of the plans should ensure their fitness for purpose.
 The EU legal framework – EC No 625/2017

Chapter VII, Article 133 – Annual reports by the Member States

1.By 31 August every year, each Member State shall submit to the Commission a report setting out:

(a) any amendments made to its MANCP to take account of the factors referred to in Article
111(2);

(b) the outcome of official controls performed in the previous year under its MANCP;

(c) the type and number of cases of non-compliance with the rules referred to in Article 1(2),
per area, detected in the previous year by the competent authorities;

(d) the measures taken to ensure the effective operation of its MANCP, including enforcement
action and the results of such measures, and

(e) a link to the web page of the competent authority containing the public information on fees or
charges referred to in Article 85(2).
 The EU legal framework – EC No 625/2017

No. of audits completed in meat plants by audit

outcome for 2018/19
600 488 420
400
200 32 3
0

Number of egg production sites, inspections and

non- compliance
2500
2059
2000

1500

1000
511 481
500
72
0
No. of registered egg No. of inspections No. of Inspections No. of Inspections not
production sites compliant compliant
 The EU legal framework – EC No 625/2017

Policy area audited Audit opinion Recommendations

Egg hygiene Moderate 2

Slaughterhouse hygiene verification system Moderate 7

Approved game handling establishments Limited 12

Approved game handling establishments Moderate 6

Minced meat, meat prep, meat products and ready to eat Moderate 10

HACCP based controls Moderate 5

 The EU legal framework – EC No 625/2017

Recital 33 – notification approach

To preserve the effectiveness of official controls in the verification of compliance, no

notice should be given prior to performing controls, unless such prior notice is
absolutely necessary for the controls to be carried out (for example, in the case of those
official controls performed in slaughterhouses during slaughter operations which require
the continuous or regular presence of staff or representatives of the competent
authorities in the operator’s premises) or the nature of the official control activities
requires otherwise (as is particularly the case with regard to audit activities).
 The EU legal framework – EC No 625/2017

Title II, Chapter III, Section II, article 33 – Delegation

Competent authorities that have delegated certain official control tasks to delegated
bodies or natural persons in accordance with Article 28(1), or certain tasks related to
other official activities to delegated bodies or natural persons in accordance with Article
31, shall:

(a) organise audits or inspections of such bodies or persons, as necessary and

avoiding duplication, taking into account any accreditation referred to in point (b)(iv)
of Article 29
 The EU legal framework – EC No 852/2004

Article 4- General and specific hygiene requirements

1. Food business operators carrying out primary production and those associated
operations listed in Annex I shall comply with the general hygiene provisions laid down in
part A of Annex I and any specific requirements provided for in Regulation (EC) No
853/2004.

2. Food business operators carrying out any stage of production, processing and
distribution of food after those stages to which paragraph 1 applies shall comply with the
general hygiene requirements laid down in Annex II and any specific requirements
provided for in Regulation (EC) No 853/2004.

3. Food business operators shall, as appropriate, adopt the following specific hygiene
measures:
(a) compliance with microbiological criteria for foodstuffs;
(b) procedures necessary to meet targets set to achieve the objectives of
this Regulation;
(c) compliance with temperature control requirements for foodstuffs;
(d) maintenance of the cold chain;
(e) sampling and analysis.
 The EU legal framework – EC No 852/2004
Article 5 - Hazard analysis and critical control points

1. Food business operators shall put in place, implement and maintain a permanent
procedure or procedures based on the HACCP principles.

2. The HACCP principles referred to in paragraph 1 consist of the following:

(a) identifying any hazards that must be prevented, eliminated or reduced to acceptable
levels;
(b) identifying the critical control points at the step or steps at which control is essential to
prevent or eliminate a hazard or to reduce it to acceptable levels;
(c) establishing critical limits at critical control points which separate acceptability from
unacceptability for the prevention, elimination or reduction of identified hazards;
(d) establishing and implementing effective monitoring procedures at critical control
points;
(e) establishing corrective actions when monitoring indicates that a critical control point is
not under control;
(f) establishing procedures, which shall be carried out regularly, to verify that the
measures outlined in subparagraphs (a) to (e) are working effectively; and
(g) establishing documents and records commensurate with the nature and size of the
food business to demonstrate the effective application of the measures outlined in
subparagraphs (a) to (f).
 The Principles of Auditing

Integrity

Fair
Risk based
presentation

Professional
Evidence based
care

Independence Confidentiality
1.- Integrity: the foundation of professionalism Auditors and the
individual(s) managing an audit programme should:

i. perform their work ethically, with honesty and responsibility;

ii. only undertake audit activities if competent to do so;
iii. perform their work in an impartial manner, i.e. remain fair and
unbiased in all their dealings;
iv. be sensitive to any influences that may be exerted on their
judgement while carrying out an audit.
 The Principles of Auditing

2.- Fair presentation: the obligation to report truthfully and accurately

 Audit findings, audit conclusions and audit reports should reflect

truthfully and accurately the audit activities.
 Significant obstacles encountered during the audit and
unresolved diverging opinions between the audit team and the
auditee should be reported.
 The communication should be truthful, accurate, objective, timely,
clear and complete.
 The Principles of Auditing

3.- Due professional care: the application of diligence and judgement in

auditing.

 Auditors should exercise due care in accordance with the

importance of the task they perform and the confidence placed in
them by the audit client and other interested parties.
 An important factor in carrying out their work with due
professional care is having the ability to make reasoned
judgements in all audit situations.
 The Principles of Auditing

4.- Confidentiality: security of information.

 Auditors should exercise discretion in the use and protection of

information acquired in the course of their duties.
 Audit information should not be used inappropriately for personal
gain by the auditor or the audit client, or in a manner detrimental
to the legitimate interests of the auditee.
 This concept includes the proper handling of sensitive or
confidential information
 The Principles of Auditing

5.- Independence: the basis for the impartiality of the audit and objectivity of
the audit conclusions
 Auditors should be independent of the activity being audited wherever
practicable, and should in all cases act in a manner that is free from
bias and conflict of interest.
 For internal audits, auditors should be independent from the function
being audited if practicable.
 Auditors should maintain objectivity throughout the audit process to
ensure that the audit findings and conclusions are based only on the
audit evidence.
 For small organizations, it may not be possible for internal auditors to
be fully independent of the activity being audited, but every effort
should be made to remove bias and encourage objectivity.
 The Principles of Auditing
6.- Evidence-based approach: the rational method for reaching reliable and
reproducible audit conclusions in a systematic audit process
 Audit evidence should be verifiable.
 It should in general be based on samples of the information available,
since an audit is conducted during a finite period of time and with finite
resources.
 An appropriate use of sampling should be applied, since this is closely
related to the confidence that can be placed in the audit conclusions.
 The Principles of Auditing

7.- Risk-based approach: an audit approach that considers risks and

opportunities
 The risk-based approach should substantively influence the
planning, conducting and reporting of audits in order to ensure
that audits are focused on matters that are significant for the audit
client, and for achieving the audit programme objectives.
The Principles of Auditing
The Principles of Auditing – audit types
 The Principles of Auditing – audit types

Systems
based

Compliance
Others based

Audit

Official Good
audits practice

Costumer/
Themed
supplier’s
audits
audits
 The Audit Process Flow – how to conduct audits

Onsite-visit
• Opening
meeting
• Documentation
Audit
Arrange audit review
preparation – Corrective
with FBO & • Site tour Report write- Submission - Follow-up
desktop • Closing action report
confirmation in up publication audit
review/draftin meeting (FBO)
written
g of checklist
2.- Audit and quality
management
systems
 Quality management systems and audits

ISO 9000:2015 describes the fundamental concepts and principles of quality

management which are universally applicable to the following:

 organizations seeking sustained success through the implementation of a

quality management system;
 customers seeking confidence in an organization's ability to consistently
provide products and services conforming to their requirements;
 organizations seeking confidence in their supply chain that their product and
service requirements will be met;
 organizations and interested parties seeking to improve communication
through a common understanding of the vocabulary used in quality
management;
 organizations performing conformity assessments against the requirements
of ISO 9001;
 providers of training, assessment or advice in quality management;
 developers of related standards.
The PDCA circle & Continuous improvement
 Auditor competencies

General

Knowledge Personal
and skills behaviour
 Auditor competencies - general

a) the size, nature, complexity, products, services and processes of

auditees;
b) the methods for auditing;
c) the management system disciplines to be audited;
d) the complexity and processes of the management system to be
audited;
e) the types and levels of risks and opportunities addressed by
the management system;
f) the objectives and extent of the audit programme;
g) the uncertainty in achieving audit objectives;
h) other requirements, such as those imposed by the audit client
or other relevant interested parties, where appropriate.
 Auditor competencies – personal behaviour
a) ethical, i.e. fair, truthful, sincere,
honest and discreet
b) open-minded, i.e. willing to consider
alternative ideas or points of view;
c) diplomatic, i.e. tactful in dealing with
individuals;
d) observant, i.e. actively observing
physical surroundings and activities;
e) perceptive, i.e. aware of and able to
understand situations;
f) versatile, i.e. able to readily adapt to
different situations;
g) tenacious, i.e. persistent and focused
on achieving objectives
h) decisive, i.e. able to reach timely
conclusions based on logical reasoning
and analysis
i) self-reliant, i.e. able to act and
function independently while
interacting effectively with others;
j) able to act with fortitude, i.e. able to
act responsibly and ethically, even
though these actions may not always
be popular and may sometimes result
in disagreement or confrontation;
k) open to improvement, i.e. willing to
learn from situations
l) culturally sensitive, i.e. observant
and respectful to the culture of the
auditee;
m) collaborative, i.e. effectively
interacting with others, including audit
team members and the auditee’s
personnel
 Auditor competencies – knowledge and skills

General - Auditors should possess:

a) the knowledge and skills necessary to achieve the intended
results of the audits they are expected to perform;
b) generic competence and a level of discipline and sector-specific
knowledge and skills
 Auditor competencies – knowledge and skills
Generic knowledge and skills of management system auditors:
a) Audit principles, processes and methods: knowledge and skills in
this area enable the auditor to ensure audits are performed in a
consistent and systematic manner.
b) Management system standards and other references:
knowledge and skills in this area enable the auditor to understand
the audit scope and apply audit criteria.
c) The organization and its context: knowledge and skills in this
area enable the auditor to understand the auditee’s structure,
purpose and management practices
d) d) Applicable statutory and regulatory requirements and other
requirements: knowledge and skills in this area enable the auditor
to be aware of, and work within, the organization’s requirements.
Knowledge and skills specific to the jurisdiction or to the auditee’s
activities, processes, products and services.
 Auditor competencies – how to achieve auditor competency

Auditor competence can be acquired using a combination of the following:

a) successfully completing training programmes that cover generic
auditor knowledge and skills;
b) experience in a relevant technical, managerial or professional position
involving the exercise of judgement, decision making, problem solving
and communication with managers, professionals, peers, customers
and other relevant interested parties;
c) education/training and experience in a specific management system
discipline and sector that contribute to the development of overall
competence;
d) audit experience acquired under the supervision of an auditor
competent in the same discipline.
Auditor evaluation
The Principles of Auditing – audit types
 The Principles of Auditing – audit types

3.- Working group

session
Each group to select one of the previous visits and identify a
spokesperson.

a) To develop an audit plan, in particular (10 mins):

 the high level sections of the check list
 with a couple of questions on two of the high level
sections identified above
Requirements for Environmental hygiene / Good hygiene Assessment
Structure
Design and layout permit good food hygiene practice and protect against
4-1
contamination between and during operations
4-2 Room size and number sufficient for different processes, species and throughput
Staff training / instruction and supervision
FBO has operating procedures in place to supervise, instruct and/or train staff in
4-11
food hygiene and work procedures commensurate to their work activity
FBO has operating procedures in place to train staff responsible for the
4-12
development and maintenance of HACCP - based procedures
The implementation of the operating procedures is effective and supported by
4-13
records
b) Based on the visit you selected (10 mins)
 describe 2 non-compliances observed, detailing the
regulatory background to support your conclusions
 and the severity of the non-compliance
c) How would you apply the CI and the PDCA circle to the
scenario you have been dealing with? (10 mins)
30 mins
 Keep in touch
ec.europa.eu/ europeancommission

europa.eu/ @EuropeanCommission

@EU_Commission EUTube

@EuropeanCommission EU Spotify

European Commission
 BTSF
ACADEM
Y
Thank you!

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