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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

    circumstances.

    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

    dx.doi.org/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

    management.

    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 processes, complexity of operation,

    quantity of product affected by the raw material used,

    market, or trade requirements.

    Similarly, the following could be considered in deciding

    the scope of an audit:

    1. whether it is an initial audit or a follow-up;

    2. size of operation, for example, number of employees,

    volume of production, and turnover;

    3. type of products and processes;

    4. complexity of operation;

    5. level of in-house expertise;

    6. amount of available resources;

    7. presence of management systems, for example, ISO quality

    management systems, and TQM;

    8. results of previous audits; and

    9. population at risk.

    A change in the system (process, formulation, etc.), or the

    aftermath of a natural accident or disaster, for example, fire, flood,

    etc., can also justify an audit. As mentioned previously, audits

    may also be triggered as results of a previous food safety incident.

    Subsequent frequencies for audits and their scope can be

    considered in the light of such findings.Competence of Auditors

    The validity of audits depends to a great extent on the com-

    petencies of auditors and their integrity. Food safety being a

    multifaceted subject, a carefully selected team of experts will

    be required. The composition of this team and the expertise of

    the members will be all the more important as the

  • 290 Food Safety Assurance Systems: Audits of Food Safety Management Systemsresponsibility for protecting public health is significant. In any

    case, for a full scope audit, the following competences, skills,

    and qualifications need to be considered:

    1. the technical competence,

    2. the skills in assessing and investigating (audit skills),

    3. the people skills, i.e., independence of judgment, integrity

    and objectivity, and finally, a good audit requires, and

    4. the cooperation and openness of the audit entity in pro-

    viding truthful information.

    Other factors such as time and financial constraints,

    availability of documents, also play a significant role.

    With regard to technical knowledge, the following are

    needed at the very least:

    1. Understanding the basic hygienic requirements, their rele-

    vance in supporting safe food production, and experience

    in assessing them.

    2. Knowledge of laws, regulations, standards and general

    codes of hygiene, and/or criteria for the specific category of

    products.

    3. Knowledge of relevant industry products and processes

    (including past failures in the category).

    4. Knowledge of the HACCP system and its application,

    including:

    a. The identification and audit of potential hazards which

    may occur during food production, handling, prepar-

    ation, storage, and transportation, including biological,

    chemical, and physical hazards.

    b. The ability to assess the effectiveness of control

    measures (validation) of the HACCP plan and its

    verification.

    5. Understanding the role of the human factor and of com-

    pany culture in food safety.Reporting Structure

    Another important factor in the validity of the audits is

    the organizational structure and the management reporting

    system. To prevent conflicts of interest, and ensure that cor-

    porate governance is functioning in all independence, it

    is important that audits are carried out by teams of pro-

    fessionals who are structurally independent from those who

    are designing and implementing the food safety management

    system.The Procedure and Methodology

    The procedure for an audit must be defined and carried out in

    accordance with a set format. Auditors should ensure that they

    plan the process properly, i.e., that:

    1. The scope of the audit is predetermined and sufficient time

    is allocated.

    2. The required skills are available within the team.

    3. Tools needed are made available.

    4. Arrangements are communicated and agreed upon with the

    site being assessed.The procedures for audit will need to include the following

    stages:

    1. a planning process to prioritize establishments, operations

    and their frequency, and scope of audits;

    2. a desktop audit;

    3. an on-site audit;

    4. an evaluation process to analyze findings, determine

    compliance, and decide corrective actions and follow-up

    requirements; and

    5. reporting and follow-up.The Planning Process

    Initial planning is important to clarify the scope of the audit

    and the approach that will be taken on-site. It helps to ensure

    that auditors have the necessary information and tools to

    complete an effective audit. Information that will help in this

    planning process includes:

    1. relevant company documentation;

    2. previous file records, data on premises and products; and

    3. results from previous visits or audits.

    The Desktop Audit

    The audit itself is best carried out in two steps. The first stage,

    desktop audit, consists of the initial review of documentation,

    which may be carried out on- or off-site.

    A desktop review also has the advantage of enabling auditors

    to plan their work, for example, to judge how the CCPs have

    been established, check the personnel required for detailed dis-

    cussions, the specific questions to be asked, draw a list of pri-

    orities to focus on, and/or areas to visit during the on-site audit.

    Examples of documents to review:

    1. The food safety policy.

    2. The organigramme, the responsibilities of the managers

    and food safety management team, and their respective

    technical expertise and competences.

    3. The operation, and the type of products produced.

    4. The range and number of raw materials used and their

    origin.

    5. A site layout plan may give an idea of the flow of products

    through the site, the scale of the operation and the prod-

    ucts produced.

    6. The HACCP-related documentation, including:

    a. a process flow diagram and specifications relating to it,

    b. the HACCP study (showing how potential hazards have

    been identified and on which basis they are considered

    as nonsignificant if this is the case),

    c. an HACCP plan, including the monitoring plan and the

    validation of the control measures,

    d. records of CCP monitoring and corrective actions fol-

    lowing the violation, and

    e. verification data, for example, consumer complaints,

    monitoring data for raw material, environment or end

    products, and reports of incidents and root cause analyses.

    7. Training programs, for example, the manual or other tools

    used for training.

  • Food Safety Assurance Systems: Audits of Food Safety Management Systems 2918. Incident and crisis management procedures.

    9. Reports of management review of food safety and quality.On-Site Audit

    The second stage is the on-site audit.

    The on-site audit will normally start with an initial or

    opening meeting to confirm, with the key people being as-

    sessed, the audit scope, timetable, facilities, and personnel

    required and in general to ensure cooperation.

    The purpose of this step of the audit is to confirm that

    procedures and practices described in the food safety man-

    agement system of the company or the regulatory require-

    ments to ensure food safety are properly implemented in

    practice.

    During the on-site visit, specific attention should be given

    to HACCP and prerequisite programs, including:

    1. Confirmation of the accuracy of the process flow dia-

    gram(s). This is facilitated by an initial walk through the

    site. The auditor will subsequently need to engage in a

    range of questioning and investigative activities to assess

    the efficacy of the HACCP system.

    2. Evaluation of the hazard analysis based on the state of the

    prerequisite programs mentioned above.

    3. Confirmation of the suitability of CCPs, critical limits, and

    corrective actions.

    4. That monitoring schedules are established and operating

    correctly.

    5. Confirmation that persons responsible at CCPs perform

    activities correctly, understand the importance of the step

    for safety, and their responsibility in case Critical Limits are

    violated. This will require specific interviews with the

    personnel.

    6. Establishing whether effective verification procedures are

    carried out.

    7. Reviewing monitoring data of raw materials, products,

    environment, CCPs, as well as reports of internal audits,

    suppliers audits (inclusive of supplier monitoring pro-

    grams), consumer complaints, personal reports, and com-

    plaints. It is particularly important to corroborate these

    results with the hazard analysis (for instance, if a con-

    taminant is considered as not significant in the raw

    material, this is confirmed through the monitoring carried

    out for verification).

    During these activities, the auditors will need to keep suf-

    ficiently detailed records and to collect supporting evidence to

    enable conclusions to be made. Use of checklists together with

    a narrative, notebooks, or where appropriate, tape recorders,

    will assist this process. Depending on the judgment of

    the auditors, checks might be made on items of equipment,

    on-site measurements may be carried out, or product or en-

    vironmental samples may be taken for subsequent laboratory

    analysis.Evaluation Process

    The auditor (or the team) will need to identify and analyze

    all information obtained during the audit in order to drawup preliminary conclusions of deficiencies found, if any,

    and their effect on food safety, regulatory compliance, or

    other trade-related concerns. They should also advise on their

    severity and the speed with which they would need to be

    rectified.Reporting and Follow-Up

    The format of auditor reports varies according to company

    policy and prior agreements with auditing bodies. However, it

    is essential that the results of the audit be communicated to

    the management of the company and to all relevant persons

    within the organization (i.e., with responsibility for safety) in

    a timely manner.

    Where an audit report indicates critical or serious gaps,

    these need to be followed up rapidly, and root cause analyses

    of these gaps are also made to identify the latent cause of the

    failures.Conclusion

    Audit of food safety management systems is an opportunity to

    improve food safety management and close the gaps. They

    should be carried out with objectivity and integrity. An un-

    satisfactory audit report should not always and necessarily be a

    reason for reprimanding the managers; rather over and above

    closing the gaps, a root cause analysis of the situation should

    be made and short- or long-term corrective action should be

    made. Not infrequently, the root of the problem may be in the

    management.

    Reports of audits and food incidents have shown that some

    of the major source of food safety problems are:

    1. Raw material and supplier management.

    2. Failure in the design of equipment and their maintenance.

    3. Good hygienic practice violation.

    4. Failure in hazard identification.

    5. CCP monitoring failure.

    6. Failure in corrective actions.

    7. Human negligence or error.Acknowledgment

    The authors would like to acknowledge that this article is

    based on personal experiences, and is also inspired from an

    earlier work, i.e., the FAO/WHO Expert Consultation that she

    convened on the subject of the Role of Government Agencies

    in Assessing HACCP (Geneva, 26 June 1998). The report

    of this meeting is available from the link http://www.who.

    int/foodsafety/fs_management/en/haccp98.pdf under the title

    Guidance on Regulatory Assessment of HACCP. The contri-

    bution of all experts in providing the guidance during the

    consultation is thankfully acknowledged. In spite of the date

    of publication of the report, much of the guidance is still

    up-to-date and relevant.

    http://www.who.int/foodsafety/fs_management/en/haccp98.pdfhttp://www.who.int/foodsafety/fs_management/en/haccp98.pdf

  • 292 Food Safety Assurance Systems: Audits of Food Safety Management SystemsSee also: Food Safety Assurance Systems: Documentation andRecord Keeping; Investigation of Incidents in Industry; PersonalHygiene and Employee Health. Public Health Measures: FoodInspections and Enforcement Systems; Modern Approach to FoodSafety Management: An OverviewFurther Reading

    Campden BRI (2009) HACCP Auditing Standard, 2nd edn. UK: Campden BRI.Dillon M and Griffith C (eds.) (2001) Auditing in the Food Industry. Cambridge,

    England: Woodhead Publishing in Food Science and Technology.FAO/WHO (1998) Guidance on regulatory assessment of HACCP. Report of a Joint

    FAO/WHO Consultation on the Role of Government Agencies in AssessingHACCP, 26 June. Geneva: World Health Organization.

    FAO/WHO (2004) Global forum of food safety regulators, building effective foodsafety systems. Proceedings of the Forum. Bangkok, Thailand, 1214 OctoberRome: FAO.

    ISO (2007) Food Safety Management Systems Requirements for Bodies ProvidingAudit and Certification of Food Safety Management Systems. ISO/TS 22003:2007. Geneva: International Standardization Organization.Motarjemi Y (2013) Human Factor in food safety management. In: Motarjemi Y andLelieveld H (eds.) Food Safety Management: A practical Guide for the FoodIndustry. Waltham, MA: Elsevier.

    Motarjemi Y and Lelieveld HLM (eds.) (2014) Food Safety Management: A PracticalGuide for the Food Industry. Waltham, MA: Elsevier.

    Motarjemi Y and Mortimore S (2013) Assessment of food safety managementsystems. In: Motarjemi Y and Lelieveld H (eds.) Food Safety Management: APractical Guide For The Food Industry. Waltham, MA: Elsevier.Relevant Websites

    http://www.fao.org/docrep/009/y6396e/y6396e00.htm

    Codex Alimentarius: Food Import and Export Inspection and Certification

    Systems.http://ftp.fao.org/docrep/fao/010/i0096e/i0096e00.pdf

    FAO: Risk-Based Food Inspection Manual.

    http://www.who.int/foodsafety/publications/fs_management/guidance/en/

    Guidance on Regulatory Assessment of HACCP: Report of a Joint FAO/WHO

    Consultation on the Role of Government Agencies in Assessing HACCP, 1998.

    http://www.iso.org/iso/home/store/catalogue_tc/

    catalogue_detail.htm?csnumber=39834

    ISO/TS 22003:2007 Food safety management systems Requirements for

    bodies providing audit and certification of food safety management systems.

    http://www.who.int/foodsafety/fs_management/en/haccp98.pdf

    Food Safety Assurance Systems: Audits of Food Safety Management SystemsFood Safety Assurance Systems: Audits of Food...IntroductionDefinition and PurposeScope and Frequency of AuditsCompetence of AuditorsReporting StructureThe Procedure and MethodologyThe Planning ProcessThe Desktop AuditOn-Site AuditEvaluation ProcessReporting and Follow-Up

    ConclusionAcknowledgmentSee alsoFurther ReadingRelevant Websites

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