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

    it is.

    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

    corporate officers.

    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

    party audit.

    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

    and/or marketed.

    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


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