Encyclopedia of Food Safety || Food Safety Assurance Systems: Audits of Food Safety Management Systems
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FOOD SAFETY ASSURANCE SYSTEMS28Audits of Food Safety Management SystemsY Motarjemi, Food Safety and Risk Management Consultant, SwitzerlandS Mortimore, Land OLakes, Inc., St. Paul, MN, USA
r 2014 Elsevier Inc. All rights reserved.GlossaryAdulteration A fraudulent action that is intended to: (i)
omit a valuable constituent or substitute another substance,
in whole or in part, for a valuable constituent; (ii) conceal
damage or inferiority in any manner; or (iii) add any
substance to increase its bulk or weight, reduce its quality or
strength, or make it appear bigger or of greater value than
Audit A systematic and functionally independent
examination to determine whether activities and related
results comply with planned objectivities.
Benchmark A reference point or standard against which
performance or achievements can be assessed. A benchmark
refers to the performance that has been achieved in the
recent past by other comparable organizations, or what can
be reasonably inferred to have been achieved in the
Compliance The products and/or practices meet
regulatory requirements (to be differentiated from
conformity which means that activities are carried out
according to the established procedures).
Control measure Any action and activity that can be used
to prevent or eliminate a food safety hazard or reduce it to
an acceptable level.Encyc8Corporate governance A system of law and sound
approaches by which corporations are directed and
controlled, focusing on the internal and external corporate
structures, with the intention of monitoring the actions of
the management and directors and thereby mitigating
agency risks which may stem from the misdeeds of
Critical control point (CCP) A step at which control can
be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable level.
Good hygienic practice A system of management
controls that need to be adopted at production, processing,
storage, distribution, and preparation to ensure safety and
suitability of products of consumption.
Hazard analysis and critical control point (HACCP)
system A preventive system which identifies, evaluates,
and controls hazards which are significant for food safety.
Validation Obtaining evidence that a control measure or
combination of control measures, if properly implemented,
is capable of controlling the hazard to a specified outcome.
Verification The application of methods, procedures, tests
and other evaluations, in addition to monitoring, to
determine whether a control measure is or has been
operating as intended.Introduction
Audits (food safety audits) refer to an industry activity to verify
that the food safety management system is implemented
correctly and effectively, and is maintained. The primary
reason for auditing food safety management systems is to es-
tablish whether a food business has the ability to consistently
produce, manufacture, or distribute safe food and to ascertain
that the food safety management provides adequate assurance.
Audits may be carried out by a business itself as part of self-
control in which case the audit is called internal audits. It
can also be carried out by an external body such as the cus-
tomer or a certification body, which is then referred to as third
In the framework of the enforcement of laws and regu-
lations, governmental authorities also verify the compliance
of industry practices with laws and regulatory requirements.
This activity is usually referred to as inspection. Today, in-
spections follow a similar process as audits and have becomevery comprehensive; although they are carried out for a dif-
ferent purpose. For a more thorough review of inspection,
the readers are referred to a specific article on this subject. The
focus of this article is on the industry audit of the food safety
management systems.Definition and Purpose
An audit is an evaluation to verify that actual practices match set
standards and codes and determine gaps, if any. With advances
of the hazard analysis and critical control point (HACCP) sys-
tem and the integrated food safety management system, the
scope and purpose of audits in the industry have shifted from a
snapshot examination of good hygienic and manufacturing
practices to a more general audit of the food safety manage-
ment systems. Thus, the primary purpose of audits is no longer
for controlling hazards, but for confirming that control/pre-
ventive measures are implemented correctly and are effective.lopedia of Food Safety, Volume 4 doi:10.1016/B978-0-12-378612-8.00368-1
Food Safety Assurance Systems: Audits of Food Safety Management Systems 289However, there are multiples reasons for which audits may
be carried out. These include:
1. Confirming the compliance (or identifying the divergence)
with the internal rules and/or regulatory requirements. This
is perhaps one of the most frequent objectives of audits.
2. Evaluating the ability of a supplier or a contractor to pro-
duce, manufacture, or transport a food according to the set
requirements. This can happen when choosing a supplier, a
contract manufacturer, or even purchasing a new business.
3. Investigating violations or incidents, for example, investi-
gating a recurring critical control point-related violation,
employee complaints, alerts by internal whistleblowers,
frequent consumer complaints, or a full-fledged incident.
4. Obtaining a certificate of assurance for the customers that
their requirements are met. This may be with customers
nationally or internationally.
5. Benchmarking or analyzing gaps in view of identifying the
need for improvement, including the need for technical as-
sistance, training and guidance on competences, and/or
improving the infrastructure (equipment, design of prem-
ises), etc. This can happen when a new factory or business is
purchased, or when companies are merged. Experience has
shown that small- or medium-size businesses are often not
resourceful enough to know the regulations that they often
learn about these when they are visited by an inspector or
assessed by a customer or the representative of a certification
body. In such a situation, to avoid conflict of interest it is
important that those involved in guiding the business are not
the same individuals who will also assess for compliance.Scope and Frequency of Audits
The scope and content of audits have also evolved with time.
Some years ago, depending on the stage of the food chain,
such audits were limited to verifying compliance with good
fishery, agriculture, farming, manufacturing, transport, or hy-
gienic practices. Later, they were developed to include audit of
HACCP. Today, with the advance of an integrated approach to
food safety management, particularly the development of ISO
22 000, audits include a variety of elements, such as:
1. Management commitment, organizational structure, cor-
porate governance and its impartiality and resources.
2. Management of people (including training).
3. Awareness and infrastructure for monitoring the regulatory
requirements of the country where products are produced
4. Product traceability, recall, and incident and crisis
5. Product development.
6. Raw materials and supplier management; this should also
include any possibility of fraud or adulteration.
7. Good hygienic practice.
8. HACCP system and implementation.
9. Verification activities (consumer complaints, pathogen and
environmental monitoring, review of noncompliances, and
their root cause analysis).The decision on the scope and frequency of audits will
depend on a number of considerations, in particular whether
the audit is a first audit or a follow-up audit. Whether a full or
a partial audit is carried out will depend on the original pur-
pose of the audit. For example, partial audits might be ap-
propriate for closing out noncompliances, for investigatory
purposes after an incident, or where a previous audit has
confirmed that a sound system is in place.
Classification of risks is an important criterion for priori-
tizing and deciding on the frequency, i.e., having more fre-
quent audits at higher-risk premises or suppliers of high-risk
material. The following information can be considered in the
classification of risks and in deciding on the frequency and
scope of the audits:
1. the potential hazards known to be associated with the
product and/ or process, including the previous records of
safety of the product;
2. the history or level of previous compliance;
3. the state of the food safety management systems and other
management systems that may be in place, for example,
ISO quality management systems and certification, total
quality management (TQM), as well as the level of in-
house expertise; and
4. other considerations such as processing methods, intended
use and population at risk, size of operation (e.g., number
of employees, volume of production, and turnover), type
of products and