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Assessment of Food Safety Management Systems
C H A P T E R
38 Assessment of Food Safety Management Systems Yasmine Motarjemi1 and Sara Mortimore2 1
Food Safety Consultant, Nyon, Switzerland, 2Land O’Lakes, Inc., MN, USA
O U T L I N E The Desktop Assessment On-site Assessment Evaluation Process Reporting and Follow-up
Introduction 987 Background 988 Definition and Purpose
989
Scope and Frequency of Assessments
989
Competence of Assessors
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The Procedure and Methodology The Planning Process
995 995
995 997 999 999
The Development and use of a Checklist 1000 Conclusions 1003 Acknowledgment 1004
INTRODUCTION At first, it is important to clarify the use of the term assessment in this chapter. For the purpose of this book, the term assessment refers to an industry or governmental activity to verify that the food safety management system is implemented correctly and effectively, and is maintained. The primary reason for assessing a food safety management system is to establish whether a food business has the ability to consistently produce, manufacture or distribute “safe” food and to ascertain that the food safety management system provides adequate assurance. In industry, the term is better known as audits, which itself is used in a variety of ways (audit of systems, processes and procedures, projects, laboratories, manufacturing,
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organizations and their management) and in different contexts such as financial, environmental or quality management. In the framework of the enforcement of laws and regulations, governmental authorities are also led to verify the compliance1 of industry practices with laws and regulatory requirements. This activity is usually referred to as inspection. In the past, inspections consisted of a snap-shot visit for checking compliance with good hygienic practice. With advances of HACCP and the development of an integrated approach to food safety management, the procedures and scope for inspection have also evolved. Today, it consists of a more comprehensive procedure similar to industry audits, referred to as regulatory audits. Therefore, while the industry and regulatory audits differ in the purpose for which they are carried out and the authority that carries out the task, in essence they use similar processes and methods; and in both cases they are carried out with the aim of verifying compliance with a given standard. Therefore, this chapter will cover food safety audits from the perspective of both governments and industry. As will be seen later, auditing processes may also be used for reasons other than verifying compliance, such as evaluating the capability of a supplier to provide a raw material according to given safety specifications, evaluating equivalence in control measures in case of export–import certification, or evaluating the status of a factory or a business. Therefore, for the purpose of this chapter, the more neutral term of assessment is used. In simple terms, we can distinguish different types of food safety assessments: 1. Internal assessments carried out by industry (part of self-control); and 2. External assessments carried out by either a. Regulatory agencies (known as inspection); or b. Third party assessments by customers or certification bodies.
BACKGROUND During the past few decades, the management of food safety has greatly evolved in both the food industry sector and the governmental agencies (see Chapter 1). This change has also made an impact on the role and responsibilities of the industry versus regulatory authorities, and on the importance that is given to inspection or audits in food safety management. While in the past the onus of safety was on governments, i.e. detecting an unsafe marketed product, with advances of the HACCP system in the last two to three decades, the responsibility for ensuring food safety and providing evidence for this has been shifted to industry. This means that the industry is to provide evidence that it is aware of the risks associated with its products and is taking the necessary preventive measures to control these. Over and above establishing clear food safety laws, standards and regulations, the role of the regulatory authorities is to verify that the industry is complying with these; the assessment of the food safety management systems of industry is part of this verification. In industry, assessments are also used as part of self-control to verify that food safety management is effectively implemented and maintained. 1
Compliance means that products and/or practices meet regulatory requirements.
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In other words, regulatory or internal assessments are not for the purpose of controlling hazards but for confirming that control/preventive measures are implemented correctly and are effective. Governmental or supplier inspection cannot be a measure to ensure safety, but a measure to verify that the processor is implementing necessary control measures and complying with safety standards and other requirements to ensure food safety. There are many books on the general aspects of assessments (audits or inspection) and the reader is referred to these sources, in particular to the ISO Standard ISO/TS 22003:2007 (see “Further Reading”). The objective of this chapter is not necessarily to turn the reader into a food safety assessor, but to highlight some essential points in an industry or regulatory assessment.
DEFINITION AND PURPOSE As mentioned before, an assessment is an evaluation to verify the actual practices against set standards and codes. The purpose of an assessment may vary. It can include: 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 assessments. ● Evaluating the ability of a supplier or a contractor to produce, 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. ● Investigating violations or incidents, for example investigating a recurring CCP-related violation, employee complaints, alerts by internal whistleblowers, frequent consumer complaints or a fully fledged incident. ● Obtaining a certificate of assurance for customers that their requirements are met. This may be with customers nationally or internationally. ● Benchmarking or analyzing gaps in view of identifying the need for improvement, including the need for technical assistance, training and guidance on competences and/or improving the infrastructure (equipment, design of premises), etc. This can happen when a new factory or business is purchased, or when companies are merged. Experience has shown that small or medium-sized businesses are often not resourceful enough to know the regulations and 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 ASSESSMENTS As mentioned before, the scope and content of assessments have also evolved with time. Some years ago, depending on the stage of the food chain, such assessments were limited to verifying compliance with good fishery, agriculture, farming, manufacturing, transport or hygienic practices. Later, they were developed to include assessment of HACCP. Today, with the advance of an integrated approach to food safety management, particularly the development of ISO 22000, assessments include a variety of elements, from prerequisite
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programs (e.g. GMP) to HACCP, supplier management, product development, training, communication with other stakeholders of the food chain and regulatory authorities, and incident and crisis management. In this chapter, an appeal is made to give particular attention to management of people and to management commitment (see Chapter 37) since the people in a company, from the general manager to the workers on the line, play a key role in food safety management. The decision on the scope and frequency of assessments or inspection will depend on a number of considerations, in particular whether the assessment is a first assessment or a follow-up assessment. Whether a full or partial assessment is carried out will depend on the original purpose of the assessment. For example, partial assessments might be appropriate for closing out non-compliances, for investigatory purposes after an incident or where a previous assessment has confirmed that a sound system is in place. Classification of risks is an important criterion for prioritizing and deciding on the frequency, i.e. having more frequent assessments 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 assessments: The potential hazards known to be associated with the product and/or process; The history or level of previous compliance; ● The state of the food safety management systems and other management systems that may be in place, e.g. ISO quality management systems and certification, TQM as well as the level of in-house expertise; ● Other considerations such as processing methods, intended use and population at risk, size of operation (e.g. number of employees, volume of production, 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 the scope of an assessment: ● ● ● ● ● ● ● ● ●
Whether it is an initial assessment or follow-up; Size of operation, e.g. number of employees, volume of production, turnover; Type of products and processes; Complexity of operation; Level of in-house expertise; Amount of available resources; Presence of management systems, e.g. ISO quality management systems, TQM; Results of previous assessments; and Population at risk.
A change in the system (process, formulation, etc.), or the aftermath of a natural accident or disaster, e.g. fire, flood etc., can also justify an assessment or an inspection. As mentioned previously, assessments may also be triggered as results of a previous food safety incident. Subsequent frequencies for assessments and their scope can be considered in the light of the findings. Table 38.1 presents the elements that could be the subject of a food safety assessment and presents some highlights of issues to be considered.
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TABLE 38.1 Elements of Food Safety Management Systems and Some Highlights of Issues to be Assessed Elements to be Assessed
Examples of Issues to be Considered During the Assessment
Management commitment, resources and management of people
This consists of ensuring that: – Management is aware of their responsibilities as listed below and set the example by following company policies. – A food safety policy is established and is communicated to all levels of the organization. – The food safety management system is described in an accessible language and is available at all levels. – The food safety management structure guarantees integrity and transparency. – A food safety leader is appointed with clear definition of his/her responsibilities and authority. – The food safety leader reports directly or has direct access to the top management of the company; he/she can report non-compliances without negative repercussions on his/her career. – The food safety management team is supported by an adequate infrastructure, equipment and material, and resources proportionate to its responsibilities and according to its scope of activities. – The responsibilities, interactions, reporting system and authorities are clear and mapped out. – The members of the team are knowledgeable, have integrity and are competent for their job. They receive training commensurate with their responsibilities and they are updated with development in the food safety areas, e.g. incidents, emerging risks, etc. – Periodic audits are used to verify the well functioning of the team as well as to provide an overview of the effective implementation of the food safety management system. – The system of corporate governance guarantees independence of audits and corrective actions, root cause investigation of gaps and incidents and their reporting to the higher management. – A system of whistleblowing is established and personnel grievances as related to their work are followed up, investigated objectively and corrective actions are implemented. – The management is open to providing necessary resources or investment where needed, supporting testing of products, making recalls in case of incidents. – The management gives priority to consumer health over business interests. – The crisis manager, if different from the food safety team leader, is also identified and competent for his/her job. – All important decisions, instructions, reports of non-compliance or possible risks, follow-up and closing out of issues are well recorded and documented.
Product traceability, recall and crisis management, incident management
– An effective traceability system is in place at the factory. – It is possible to trace every consumer unit. – It is possible to identify all finished products manufactured from a given consignment of incoming material, including rework. – Traceability exercises are carried out regularly, at least once a year to ensure that the traceability system is effective. – A formal written procedure for product recall is available and the system is tested periodically. – A formal early warning, crisis management procedure and crisis committee are in place and the role and responsibilities of the members are specified. – Incidents are thoroughly investigated, root causes established and lessons learned from the incidents are disseminated across the organization to prevent their recurrence. – Senior management is engaged in incident debriefs and preventive action. (Continued)
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Elements of Food Safety Management Systems and Some Highlights of Issues to be Assessed TABLE 38.1 (Continued) Elements to be Assessed
Examples of Issues to be Considered During the Assessment
Raw materials and supplier management
– Supplier management is in place: suppliers are selected and approved based on their capability to ensure safety of the raw material and are periodically audited and monitored. – Suppliers are aware of the intended use of their products and of the regulatory requirements of the country where their product will be used or these are indicated in the specifications. – Supplier auditors have the appropriate experience and training to enable them to carry out a risk-based assessment at the supplier’s manufacturing location. – Raw materials (ingredients and packaging) have clear specifications and are signed to indicate agreement between the supplier and customer. – Certificates of analysis (where used) come from a laboratory that is able to competently test and samples are appropriately handled. The sensitivity of methods used are adequate for meeting the safety and regulatory requirements
Good hygienic practice (GHP)
– Incoming raw materials are inspected for their integrity authenticity and final goods are stored safely. – Warehouse management is in place, e.g. first in first out (FIFO) is respected, and raw material is properly labeled – Pest management is effective. – Adequate security measures are foreseen and visitors are screened for both health and security. – Housekeeping issues are respected, e.g. where applicable tools are labeled, chemicals are kept in a safe and secure location, identification (e.g. color coding) systems are used for tools, 5 S system is used for maintaining order. – Training of employees is comprehensive and validated for effectiveness of learning: personal health and hygienic behavior protocols are observed as verification that knowledge is being reinforced in the facility. Employee facilities for hygiene, such as lockers, bench barrier entryways (where needed) and hand-washing facilities are readily available. – Basic rules of food hygiene are also respected in canteens. – Buildings (including drains) are designed to minimize risks and meet hygienic requirements. Doors and windows are appropriately closed and screened. – Zoning (including air flow and the need of a filter) and flow of people are managed to minimize risk of cross-contamination throughout the facility. – Hygienic design of equipment and maintenance programs, including calibration of equipment, are followed rigorously according to the state of the art. – Food grade lubricants are used. – Industrial services are managed to maintain a safe production environment. – Cleaning procedures are correctly laid out, are valid and the implementation is verified. – Rejected raw material or final products are correctly handled and disposed of. – In case of maintenance work, the impact of the work is considered in risk and control measures. – Foreign matters are prevented through various measures and policies, such as glass-free policy, jewelry-free policy. – Consumers’, customers’ and regulatory authorities’ complaints are properly recorded and investigated and followed up in a timely manner. – Products are correctly labeled (content, visibility, clarity) and where consumers’ practice is critical for safety, the communication of safety information is validated for accuracy and clarity. – Before launching or modifying any product, it is ensured that regulatory or safety requirements are met. – Examination of the area, such as security measures for the premises and screening of visitors and subcontractors for security as well as their health status. (Continued)
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Elements of Food Safety Management Systems and Some Highlights of Issues to be Assessed TABLE 38.1 (Continued) Elements to be Assessed
Examples of Issues to be Considered During the Assessment
HACCP – Adequacy of the hazard analysis. All potential hazards are adequately identified and system and evaluated, and if this evaluation indicates the risk is insignificant, is this validated implementation by data? – Validity of control measures, i.e. the control measures eliminate or reduce the hazards to acceptable levels. – CCPs are identified, and critical limits are identified and operating within food safety and regulatory limits. Evidence should be obtained as to how these were determined, including the expertise used and any supportive document to validate these. – Evidence should be obtained that the monitoring of the critical limits indicates adequate control of the hazards. The adequacy of training in relation to personnel working at the CCPs and engaged in monitoring should also be considered, e.g. whether suitable instructions have been given to such personnel, and their role in relation to appropriate and timely actions. – An assessment as to whether the corrective actions would adequately restore control and are adequate to prevent an unsafe product from reaching the consumer. – An assessment of what, how, when and by whom the verification procedures have been undertaken, and whether these are adequate and effective. This may be indicated by an assessment of the validation data, sampling results, internal and external audit documentation as well as the frequency and thoroughness of all verification activities. The assessor should also consider whether changes, deficiencies in the HACCP plan, new emerging hazards, etc., are adequately provided for. Assessors should consider what actions are taken as a result of inadequacies in the HACCP plan or its prerequisites, or any other non-conformitya. – Additionally, assessors should consider whether records and documents are complete and in order. Where records indicate an issue or non-compliance, how these have been followed up. – The assessors should also evaluate the adequacy of the implementation, i.e. whether the HACCP plan and the prerequisites for HACCP have actually been implemented in the food business, maintained and are functioning correctly. – Root cause of CCP violations, or near miss investigations are carried out and short- and longterm corrective measures are in place. Verification activitiesa
– Internal audits are carried out regularly by a competent team; they cover all levels and aspects of the operations and unsatisfactory reports are subject to an investigation and root cause analysis. – Consumer complaint handling system is valid and is working effectively, i.e. personnel are trained in what to do, how to ask questions and they have the ability to connect different sets of information to detect a pattern or a cluster of non-compliances. – Suppliers are audited according to a risk-based program by a competent team. The results of the supplier audits, including the monitoring activities of the suppliers (e.g. their end-product testing), are considered in the hazard analysis and maintenance of the HACCP plan. – The assessment of GHP and equipment maintenance programs is carried out on a regular basis. – The system for recording consumer complaints is verified and it is ensured that it is working effectively. – The pathogen and environmental monitoring as well as raw- and end-product testing are carried out effectively and results are regularly reviewed and used for the validation of the GHP program, and also for the maintenance of the HACCP system. – Laboratories carrying out chemical and microbial testing are audited for good laboratory practice and are accredited. (Continued)
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Elements of Food Safety Management Systems and Some Highlights of Issues to be Assessed TABLE 38.1 (Continued) Elements to be Assessed Verification activitiesb
Examples of Issues to be Considered During the Assessment – HACCP teams receive the results of various verification activities. – Hazard analyses are reviewed based on the verification data and where necessary, e.g. a non-compliance or a change, the HACCP plan is revised accordingly. – A release procedure is in place for finished products and raw materials. – Senior management reviews the status of the food safety program, including reports of audits, incidents, consumer complaints or other non-compliances reported by the staff. – Periodic traceability, recall and crisis management exercises, or other verifications, are carried out in an effective manner.
a
Conformity means that activities are carried out according to the established procedures. This is part of the HACCP system; however, as described in Chapter 1, to highlight the importance of verification activities for the validation of the hazard analysis and maintenance of HACCP, they are mentioned separately. b
COMPETENCE OF ASSESSORS The validity of assessments depends to a great extent on the competencies of assessors 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 responsibility for protecting public health is significant. In any case, for a full scope assessment, the following competences, skills and qualifications need to be considered: The technical competence; The skills in assessing and investigating (audit skills); ● The interpersonal skills and values, i.e. communications skills, diplomacy, resilience, patience, self-discipline and open mindedness. In addition they need to be curious and analytical in how they should interpret what they observe; ● Finally, a good assessment requires the cooperation and openness of the assessment entity in providing truthful information. ● ●
Other factors such as time and financial constraints and availability of documents also play a significant role. With regard to technical knowledge, the following are needed at the very least: Understanding the basic hygienic requirements, their relevance in supporting safe food production, and experience in assessing them; ● Knowledge of laws, regulations, standards and general codes of hygiene and/or criteria for the specific category of products; ● Knowledge of relevant industry products and processes (including past failures in the category); ● Knowledge of the HACCP system and its application, including: ● The identification and assessment of potential hazards which may occur during food production, handling, preparation, storage and transportation, including biological, chemical and physical hazards; ●
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The ability to assess the effectiveness of control measures (validation) of the HACCP plan and its verification; ● Understanding the role of the human factor and of company culture in food safety. ●
THE PROCEDURE AND METHODOLOGY The procedure for an assessment must be defined and carried out in accordance with a set format. Assessors should ensure that they plan the process properly, i.e. that: ● ● ● ●
The scope of the assessment is predetermined and sufficient time is allocated; The required skills are available within the team; Tools needed are made available; Arrangements are communicated and agreed upon with the site being assessed. The procedures for assessment will need to include the following stages:
1. A planning process to prioritize establishments, operations and their frequency and scope of assessments; 2. A desktop assessment; 3. An on-site assessment; 4. An evaluation process to analyze findings, determine compliance and decide corrective actions and follow-up requirements; 5. Reporting and follow-up.
The Planning Process Initial planning is important to clarify the scope of the assessment and the approach that will be taken on-site. It helps to ensure that assessors have the necessary information and tools to complete an effective assessment. Information that will help in this planning process includes: Relevant company documentation; Previous file records, data on premises and products; and ● Results from previous visits or assessments. ● ●
The information obtained at this planning stage will also help to determine the focus of the assessment and the skills that might be necessary, particularly where assessments are carried out by a team. It also provides an opportunity to refine any checklist and protocols that might be used and, where appropriate, to communicate arrangements of the visits to the establishment. Any material such as camera, flashlight, tool kits, safety shoes, documentation and manuals can also be foreseen at this stage.
The Desktop Assessment The assessment itself is best carried out in two steps. The first stage, desktop assessment, consists of the initial review of documentation, which may be carried out on- or off-site.
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Although it is possible to carry out an assessment without a prior review of documentation, experience shows that a review of these prior to visiting the site leads to a more focused, thorough and informed assessment. A review of the documentation allows assessors to get an idea of the standards that are relevant to examine and become familiar with the site products and processes. It will give the assessors an opportunity to carry out some research to build up knowledge of the product technology, legislative control measures and/or industry standards. A desktop review also has the advantage of enabling assessors to plan their work, e.g. to judge how the CCPs have been established, check the personnel required for detailed discussions, review the specific questions to be asked, draw a list of priorities to focus on and/ or examine areas to visit during the on-site assessment. If the assessors find on the other hand that the document review has indicated obvious inadequacies, they may decide to stop the assessment at this point instead of proceeding to the on-site verification. Based on the findings, the assessors may decide to communicate to the company the type of measures which it needs to take. A review of the company documentation is best carried out off-site, particularly when government agencies are concerned. In some instances, there may be some constraints that make this difficult or impractical, for example where the assessment is of an urgent investigatory nature or where it is intended to be unannounced. However, even where this can only take place on-site, it is important to review and make use of relevant documentation prior to a further physical examination of the site premises, processes and procedures. A review of the flow diagram or site plan, for example, will provide information on the nature and scale of activities carried out. This will help to target the assessment, particularly the further necessary scrutiny of records, equipment and processes. Examples of documents to review: The food safety policy. The organigram, the responsibilities of the managers and food safety management team, and their respective technical expertise and competences. ● The operation and the type of products produced. ● The range and number of raw materials used and their origin. ● A site layout plan may give an idea of the flow of products through the site, the scale of the operation and the products produced. ● The HACCP-related documentation, including: ● A process flow diagram and specifications relating to it; ● The HACCP study (showing how potential hazards have been identified and on which basis they are considered as non-significant if this is the case); ● An HACCP plan, including the monitoring plan and the validation of the control measures; ● Records of CCP monitoring and corrective actions following the violation; ● Verification data, e.g. consumer complaints, monitoring data for raw material, environment or end products, reports of incidents and root cause analyses. ● Training programs, e.g. the manual or other tools used for training. ● Incident and crisis management procedures. ● ●
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Records of investigation and root cause analysis of incidents (both active and latent failures) as well as evidence of follow up and corrections of gaps and dissemination of lessons learned from the incidents. ● Reports of management review of food safety and quality. ●
Together with the type of products and operation, such information is crucial for planning the assessment, particularly of high risk products but also to gauge if the number of personnel and their qualifications are adequate to manage the safety of the products. Many organizations use a pre-assessment survey to organize the information required for this type of desktop assessment.
On-site Assessment The second stage is the on-site assessment. This will normally start with an initial or opening meeting to confirm, with the key people being assessed, the assessment scope, timetable, facilities and personnel required and in general to ensure cooperation. The time and location of the closing meeting could be confirmed and any additional documentation required for on-site document review could be requested at this stage. As a regulatory authority, inspections may be carried out unannounced. This has the advantage of examining the place and practices as they are on an everyday basis and of obtaining the best picture of the real practices. However, there is also a disadvantage in that appropriate personnel may not be available to answer questions or that the inspection may disrupt the workflow, which itself can create other opportunities for mistakes leading to risk for consumers. In an announced visit, it is helpful to prepare an agenda for the assessment program to ensure that relevant personnel are available during the assessment, and that their routine work is not disturbed more than it needs to be. The purpose of this step of the assessment is to confirm that procedures and practices described in the food safety management system of the company or the regulatory requirements to ensure food safety are properly implemented in practice. The scope of the assessment should have been decided during the planning stage. However, it could change depending on the findings of the on-site review of information, particularly if an off-site review (pre-assessment) was not done and the on-site assessment represents the first examination of the material. The scope of the assessment should also be changed during the assessment if serious non-compliance/deficiencies are seen. The on-site assessment will consist of a combination of activities. It should start with a review of the relevant documentation, their adequacy and accuracy. A special focus should be put on HACCP, understanding the flow diagram, the competence of the team, the hazard analysis and validity of the decision taken in the HACCP study. It will then move on to a physical examination of the processes, practices and records, by observation, measurement or interview to assess whether the actual operation in practice complies with the documented procedures. An important activity during this process is the evaluation of the state of prerequisite programs, including good hygienic practices
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according to the Codex General Principles of Hygiene or any other hygienic codes which may be applicable for the product or process in question. Such an examination will include the criteria listed earlier in Table 38.1. During the on-site visit, specific attention should be given to HACCP implementation, including: Confirming the accuracy of the process flow diagram(s). This is facilitated by an initial walk through the site. The assessor will subsequently need to engage in a range of questioning and investigative activities to assess the efficacy of the HACCP system. ● Evaluating the hazard analysis taking into consideration the state of the prerequisite programs mentioned above. ● Confirming the suitability of CCPs, critical limits and corrective actions. ● Confirming that monitoring schedules are established and operating correctly. ● Confirming 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. ● Establishing whether effective verification procedures are carried out. ● Reviewing monitoring data of raw materials, products, environment, CCPs, as well as reports of internal assessments, suppliers’ assessments (inclusive of supplier monitoring programs), consumer complaints, personal reports and complaints. It is particularly important to corroborate these results with the hazard analysis (for instance, if a contaminant is considered as not significant in the raw material, this is confirmed through the monitoring carried out for verification). ●
During these activities, the assessors will need to keep sufficiently 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 assessors, checks might be made on items of equipment, on-site measurements may be carried out, or product or environmental samples may be taken for subsequent laboratory analysis. Additionally, assessors may Carry out tests to verify the well functioning of the traceability system. Check awareness of the regulatory requirements of the country where products are produced and/or marketed. ● Evaluate the knowledge and training of key personnel in food safety in relation to the job they are required to do. ● Review the handling of non-compliances (incidents of food contamination) or complaints from the regulatory authorities. ● Examine the organization’s management structure to determine whether there are issues which may create conflict and undermine the reporting of non-compliances and/or investigation of incidents. The reporting system to ensure that top management is informed in a timely manner of food safety incidents or serious gaps in the company program, including managers’ attitude and behavior, is a critically important element. ● ●
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Evaluation Process Where the assessment is being carried out by a team and a range of skills are being utilized, the evaluation and conclusions drawn will need to be agreed in advance of any final meeting with the site representatives. The assessor (or the team) will need to identify and analyze all information obtained during the assessment in order to draw up preliminary conclusions of deficiencies found, if any, and their effect on food safety, regulatory compliance or other trade-related concerns. Assessors should use the findings of their investigations to evaluate the effect any deficiencies may have on food safety and the speed with which they would need to be rectified. The assessors(s) should evaluate findings based on objective evidence drawn from qualitative or quantitative information, records, statements, observations, measurements or tests which demonstrate that the prerequisites for HACCP or the HACCP system itself would not compromise food safety. Information and records gathered should be organized into a format that would support and justify the presentation of findings. It is beneficial to provide feedback on any positive findings of the assessment, where appropriate. This helps in presenting a balanced view. At the exit meeting, the assessor will need to discuss non-compliances/deficiencies and agree on the expected corrective actions. The approach taken at this stage will depend on the purpose of the assessment, for example when the assessment had been triggered off by a serious food safety problem or where the assessment was to exclude previously identified deficiencies. However, in all circumstances, it is preferable to present any findings in a methodical manner, specifically highlighting best practices as well as areas of critical noncompliance or deficiencies. The company should be given the opportunity to put forward its own solutions, as these may have substantial economic consequences such as capital expenditure, recruitment of new personnel, retraining of personnel or change of suppliers. A timeframe for corrective actions should be decided according to the importance of the gaps identified. At the conclusion of any assessment, the company should be clear on any immediate remedial action required. The remedial action should be communicated to the site representatives with the appropriate responsibility. In some cases, written assessment reports might only follow more detailed off-site evaluation of the findings by the assessor. However, in all cases, it is necessary for the assessors to engage in follow-up activities to ensure that reported non-conformance is rectified. The actions taken by government agencies where deficiencies are noted will depend on the nature of the identified deficiency, i.e. whether it is a non-conformance or a noncompliance. Some deficiencies will not have a direct impact on food safety. Assessors will need to have sufficient skills and competencies to evaluate the impact of deficiencies. Other factors which will influence the action taken will include evidence of a repetitive pattern suggesting insufficient control that could lead to an adverse food safety problem.
Reporting and Follow-up The format of assessor reports varies according to company policy and prior agreements with assessment bodies. However, it is essential that the results of the assessment be
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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 assessment 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 (see Chapter 37).
THE DEVELOPMENT AND USE OF A CHECKLIST Very often, to assess an operation assessors work from a checklist, i.e. a list of points to be considered during an assessment. Such a checklist is a useful tool for the assessment of the food safety management system provided that assessors are aware of its limitations and do not refrain from pursuing additional avenues of inquiry. Such a list has certain advantages and disadvantages (Table 38.2). A checklist should be designed so that a quantitative or qualitative measure of the evaluation can be recorded. An example of qualitative evaluation would be the use of the terms: “excellent, good, medium, and poor” or “critical, serious, major, minor.” Space should also be provided for written comments and objective evidence to be recorded next to each heading. The content of a checklist will depend upon the purpose of the specific assessment being undertaken and a specific checklist should be designed for each specific sector of the food chain. To facilitate their application, checklists should be supported by an assessment reference manual to guide the assessor in their correct and consistent application. As an example, a list of commonly used questions in regard to assessment of HACCP is provided below. It does not represent a comprehensive checklist; it intends to show how a list may look and the sort of questions and activities which may lead to an effective assessment (Table 38.3).
TABLE 38.2 Advantages and Limitations of a Checklist Concerns and Potential Misuse of Checklists
Advantages of Checklists – – – – – –
– – –
Function as an aide-memoire Help maintain the focus and objectivity of the assessment Act as a record of the assessment itself Ensure the completeness of the assessment Are a useful tool in ensuring consistency of approach between different assessors Help, together with associated reference manuals, to evaluate the comparability of different assessments, different companies or different assessors Ensure transparency of the assessment process Create confidence in the assessment process by all concerned, including government, industry and consumers Enable assessment data to be more easily entered into a database which, in turn, can be used for reporting and trend analysis
– If designed or used improperly, may restrict the initiative and judgment of the assessors and discourage critical thinking and evaluation – It is important that the use of a checklist not evolve into a simple “tick-box” approach where there is no critical evaluation – A checklist may be improperly designed so that it may include unnecessary or irrelevant items, or may omit critical points
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The Development and use of a Checklist
TABLE 38.3 An Example of Checklist for the Assessment of the HACCP System Preparatory activities
What evidence is there of management commitment to HACCP use? HACCP team – Who was on the team? – Are all disciplines relevant to the product in question represented? – What is the likely knowledge level of the individuals (evidence of training, qualifications, experience, etc.)? – Has external expertise been sought where necessary? – What is the decision-making leverage of the HACCP team leader? HACCP system – How does the system fit with the overall food safety management system? – Is HACCP included in the food safety policy? – Has the scope been clearly defined? – Are previous records of safety (e.g. incidents) known to the team? – Has the product been properly described? – Are intrinsic control measures identified? Process flow diagram (PFD) – Is the PFD comprehensive? – How was the PFD verified for accuracy and by whom? – Are all raw materials and process/storage activities included in the flow diagram? – Are there rework opportunities and have they been included? – Is the PFD correct? – Have changes been made since the PFD was drawn up? – How is the HACCP team notified of changes to the process or product parameters? – How were the changes recorded and approved? – Were any changes discussed with the HACCP team before implementation?
Principle 1 “Conducting a hazard analysis”
How was the hazard analysis conducted? – Have all raw materials (including rework) been included? – Have all process steps been considered? – Have the potential hazards been specifically identified by type/source or have they been generalized? – How did the team assess the likelihood of occurrence? – What information sources were utilized? – Where potential hazards have been considered as insignificant have these been validated? Have appropriate control measures (CMs) been identified for each hazard? – Will the CMs control the hazards to an acceptable level and how was this validated? – Have regulatory requirements been considered in making these decisions? – Are all the CMs in place at the plant level?
Principle 2 “Determining the Critical Control Points”
How were the CCPs identified? – By expert judgment? – By the use of a decision tree (has the decision tree been used correctly?)? – By the use of consultants? – Have all necessary CCPs been identified? – Did each identified hazard undergo a systematic consideration? – How are the hazards which are not controlled by CCPs addressed? (Continued)
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TABLE 38.3 38.3 (Continued) An Example of Checklist for the Assessment of the HACCP System TABLE Principle 3 “Establishing Critical Limits”
How were the critical limits established? – Have critical limits been established for each CCP? – What validation exists to confirm that the critical limits control the hazards identified? – Is there evidence (experimental data, literature references, etc.)? – How do they differ from operational limits?
Principle 4 “Establishing a system to monitor the control of the CCP”
Have realistic monitoring schedules been established? – Do they cover all CCPs? – Has the reliability of monitoring procedures been assessed where appropriate? – What is the status of monitoring equipment? – Is it evidenced as being in place and calibrated appropriately? – Are the CCP log sheets being used at all CCPs? – Have CCP log sheets been filled out correctly? – Is there any evidence that procedures are not being followed consistently? – Does the frequency of monitoring adequately confirm control? – Are the sampling plans statistically valid? – Are statistical process control records being used to demonstrate that the process is in control on a day-to-day basis? – Check that records agree with stated activities. Are monitoring personnel properly identified and trained? – How was the training undertaken? – Are the monitoring records being reviewed by designated appropriate reviewers? Are violations of CCPs investigated and root cause analysis made?
Principle 5 “Establishing the corrective action to be taken when monitoring indicates that a particular CCP is not under control”
– Have the corrective actions been properly defined so that control is regained? – What evidence is there to demonstrate that this is being done in the event of a CCP deviation? – Has corrective action been recorded and how is the effectiveness being verified? – How has the authority for corrective action been assigned? – How are non-conforming products controlled and is this clearly recorded? – Are there clear disposition actions listed?
Principle 6 “Establishing procedures for verification to confirm that the HACCP system is working effectively”
– – – – – – – – – – – – –
Have verification procedures been clearly and appropriately established? How are these procedures communicated through the business? Have responsibilities for verification procedures been allocated? Are they being carried out effectively? Are all CCPs covered by the verification program? Are hazards considered as non-significant validated through verification programs? Is there a formal system to trigger amendments? Are control parameters being achieved? Have process capability studies been carried out? How are the data from HACCP being used to improve the system? Are prerequisite support systems included within the verification program? How is consumer complaint data being used within the verification system? Is there a regular review of CCP failure and product dispositions? (Continued)
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Conclusions
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An Example of Checklist for the Assessment of the HACCP System TABLE 38.3 (Continued) Principle 7 “Establishing documentation concerning all procedures and records appropriate to these principles and their application”
What format is being used to document the system? – Does the documentation cover all of the HACCP system operation, including: (1) the description of the product and its intended use, (2) the process flow diagram with the location of CCPs and related parameters available, (3) the HACCP worksheets on which are mentioned the hazards, the control measures, the CCPs, the critical limits, the monitoring procedures and the corrective actions, (4) data used for validation of hazard analysis, critical limits and monitoring parameters, corrective and verification activities, (5) the list of verification activities, (6) the results of monitoring and verification of the HACCP plan, and (7) the appropriate records necessary to ensure adequacy of prerequisite programs, particularly those used for validation of hazard analysis? – How is the documentation controlled with regard to update and issue, etc.? – Are the records accessible and are they clearly identified by unique reference numbers? – Are all documents accurate and current? – How is change control managed?
Implementation
Have the HACCP plan and the prerequisites for HACCP been implemented? – Personnel are trained in managing CCPs and know what to do when the CCPs are violated. – Personnel involved in verification activities and prerequisite activities are aware of the significance of their work for supporting the HACCP system and of the importance of reporting any non-compliance.
CONCLUSIONS Assessment of food safety management systems is an opportunity to improve food safety management and close the gaps. It should be carried out with objectivity and integrity. An unsatisfactory 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-term 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 sources of food safety problems are: ● ● ● ● ● ● ●
Raw material and supplier management. Failure in the design of equipment and its maintenance. GMP violation. Failure in hazard identification. CCP monitoring failure. Failure in corrective actions. Human negligence or error.
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Acknowledgment The authors would like to acknowledge that this chapter is based on personal experiences but also inspired from an earlier work, i.e. the FAO/WHO Expert Consultation that they convened on the subject of the Role of Government Agencies in Assessing HACCP (Geneva, 2–6 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 contribution 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.
Further Reading Dillon, M., Griffith, C. (Eds.), 2001. Auditing in the Food Industry. Woodhead Publishing in Food Science and Technology, Cambridge England. Campden, B.R.I., 2009. HACCP Auditing Standard, second ed. Campden BRI, UK. FAO/WHO Guidance on Regulatory Assessment of HACCP. Report of a Joint FAO/WHO Consultation on the role of Government Agencies in Assessing HACCP. Geneva, 2–6 June 1998, World Health Organization. FAO/WHO. Global Forum of Food Safety Regulators, Building effective food safety systems. Proceedings of the Forum 12–14 October 2004, Bangkok, Thailand. ISO. Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems. ISO/TS 22003:2007. International Standardization Organization, 2007.
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38 Assessment of Food Safety Management Systems Yasmine Motarjemi1 and Sara Mortimore2 1
Food Safety Consultant, Nyon, Switzerland, 2Land O’Lakes, Inc., MN, USA
O U T L I N E The Desktop Assessment On-site Assessment Evaluation Process Reporting and Follow-up
Introduction 987 Background 988 Definition and Purpose
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Scope and Frequency of Assessments
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Competence of Assessors
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The Procedure and Methodology The Planning Process
995 995
995 997 999 999
The Development and use of a Checklist 1000 Conclusions 1003 Acknowledgment 1004
INTRODUCTION At first, it is important to clarify the use of the term assessment in this chapter. For the purpose of this book, the term assessment refers to an industry or governmental activity to verify that the food safety management system is implemented correctly and effectively, and is maintained. The primary reason for assessing a food safety management system is to establish whether a food business has the ability to consistently produce, manufacture or distribute “safe” food and to ascertain that the food safety management system provides adequate assurance. In industry, the term is better known as audits, which itself is used in a variety of ways (audit of systems, processes and procedures, projects, laboratories, manufacturing,
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© 2014 Elsevier Inc. All rights reserved.
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organizations and their management) and in different contexts such as financial, environmental or quality management. In the framework of the enforcement of laws and regulations, governmental authorities are also led to verify the compliance1 of industry practices with laws and regulatory requirements. This activity is usually referred to as inspection. In the past, inspections consisted of a snap-shot visit for checking compliance with good hygienic practice. With advances of HACCP and the development of an integrated approach to food safety management, the procedures and scope for inspection have also evolved. Today, it consists of a more comprehensive procedure similar to industry audits, referred to as regulatory audits. Therefore, while the industry and regulatory audits differ in the purpose for which they are carried out and the authority that carries out the task, in essence they use similar processes and methods; and in both cases they are carried out with the aim of verifying compliance with a given standard. Therefore, this chapter will cover food safety audits from the perspective of both governments and industry. As will be seen later, auditing processes may also be used for reasons other than verifying compliance, such as evaluating the capability of a supplier to provide a raw material according to given safety specifications, evaluating equivalence in control measures in case of export–import certification, or evaluating the status of a factory or a business. Therefore, for the purpose of this chapter, the more neutral term of assessment is used. In simple terms, we can distinguish different types of food safety assessments: 1. Internal assessments carried out by industry (part of self-control); and 2. External assessments carried out by either a. Regulatory agencies (known as inspection); or b. Third party assessments by customers or certification bodies.
BACKGROUND During the past few decades, the management of food safety has greatly evolved in both the food industry sector and the governmental agencies (see Chapter 1). This change has also made an impact on the role and responsibilities of the industry versus regulatory authorities, and on the importance that is given to inspection or audits in food safety management. While in the past the onus of safety was on governments, i.e. detecting an unsafe marketed product, with advances of the HACCP system in the last two to three decades, the responsibility for ensuring food safety and providing evidence for this has been shifted to industry. This means that the industry is to provide evidence that it is aware of the risks associated with its products and is taking the necessary preventive measures to control these. Over and above establishing clear food safety laws, standards and regulations, the role of the regulatory authorities is to verify that the industry is complying with these; the assessment of the food safety management systems of industry is part of this verification. In industry, assessments are also used as part of self-control to verify that food safety management is effectively implemented and maintained. 1
Compliance means that products and/or practices meet regulatory requirements.
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In other words, regulatory or internal assessments are not for the purpose of controlling hazards but for confirming that control/preventive measures are implemented correctly and are effective. Governmental or supplier inspection cannot be a measure to ensure safety, but a measure to verify that the processor is implementing necessary control measures and complying with safety standards and other requirements to ensure food safety. There are many books on the general aspects of assessments (audits or inspection) and the reader is referred to these sources, in particular to the ISO Standard ISO/TS 22003:2007 (see “Further Reading”). The objective of this chapter is not necessarily to turn the reader into a food safety assessor, but to highlight some essential points in an industry or regulatory assessment.
DEFINITION AND PURPOSE As mentioned before, an assessment is an evaluation to verify the actual practices against set standards and codes. The purpose of an assessment may vary. It can include: 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 assessments. ● Evaluating the ability of a supplier or a contractor to produce, 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. ● Investigating violations or incidents, for example investigating a recurring CCP-related violation, employee complaints, alerts by internal whistleblowers, frequent consumer complaints or a fully fledged incident. ● Obtaining a certificate of assurance for customers that their requirements are met. This may be with customers nationally or internationally. ● Benchmarking or analyzing gaps in view of identifying the need for improvement, including the need for technical assistance, training and guidance on competences and/or improving the infrastructure (equipment, design of premises), etc. This can happen when a new factory or business is purchased, or when companies are merged. Experience has shown that small or medium-sized businesses are often not resourceful enough to know the regulations and 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 ASSESSMENTS As mentioned before, the scope and content of assessments have also evolved with time. Some years ago, depending on the stage of the food chain, such assessments were limited to verifying compliance with good fishery, agriculture, farming, manufacturing, transport or hygienic practices. Later, they were developed to include assessment of HACCP. Today, with the advance of an integrated approach to food safety management, particularly the development of ISO 22000, assessments include a variety of elements, from prerequisite
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programs (e.g. GMP) to HACCP, supplier management, product development, training, communication with other stakeholders of the food chain and regulatory authorities, and incident and crisis management. In this chapter, an appeal is made to give particular attention to management of people and to management commitment (see Chapter 37) since the people in a company, from the general manager to the workers on the line, play a key role in food safety management. The decision on the scope and frequency of assessments or inspection will depend on a number of considerations, in particular whether the assessment is a first assessment or a follow-up assessment. Whether a full or partial assessment is carried out will depend on the original purpose of the assessment. For example, partial assessments might be appropriate for closing out non-compliances, for investigatory purposes after an incident or where a previous assessment has confirmed that a sound system is in place. Classification of risks is an important criterion for prioritizing and deciding on the frequency, i.e. having more frequent assessments 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 assessments: The potential hazards known to be associated with the product and/or process; The history or level of previous compliance; ● The state of the food safety management systems and other management systems that may be in place, e.g. ISO quality management systems and certification, TQM as well as the level of in-house expertise; ● Other considerations such as processing methods, intended use and population at risk, size of operation (e.g. number of employees, volume of production, 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 the scope of an assessment: ● ● ● ● ● ● ● ● ●
Whether it is an initial assessment or follow-up; Size of operation, e.g. number of employees, volume of production, turnover; Type of products and processes; Complexity of operation; Level of in-house expertise; Amount of available resources; Presence of management systems, e.g. ISO quality management systems, TQM; Results of previous assessments; and Population at risk.
A change in the system (process, formulation, etc.), or the aftermath of a natural accident or disaster, e.g. fire, flood etc., can also justify an assessment or an inspection. As mentioned previously, assessments may also be triggered as results of a previous food safety incident. Subsequent frequencies for assessments and their scope can be considered in the light of the findings. Table 38.1 presents the elements that could be the subject of a food safety assessment and presents some highlights of issues to be considered.
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TABLE 38.1 Elements of Food Safety Management Systems and Some Highlights of Issues to be Assessed Elements to be Assessed
Examples of Issues to be Considered During the Assessment
Management commitment, resources and management of people
This consists of ensuring that: – Management is aware of their responsibilities as listed below and set the example by following company policies. – A food safety policy is established and is communicated to all levels of the organization. – The food safety management system is described in an accessible language and is available at all levels. – The food safety management structure guarantees integrity and transparency. – A food safety leader is appointed with clear definition of his/her responsibilities and authority. – The food safety leader reports directly or has direct access to the top management of the company; he/she can report non-compliances without negative repercussions on his/her career. – The food safety management team is supported by an adequate infrastructure, equipment and material, and resources proportionate to its responsibilities and according to its scope of activities. – The responsibilities, interactions, reporting system and authorities are clear and mapped out. – The members of the team are knowledgeable, have integrity and are competent for their job. They receive training commensurate with their responsibilities and they are updated with development in the food safety areas, e.g. incidents, emerging risks, etc. – Periodic audits are used to verify the well functioning of the team as well as to provide an overview of the effective implementation of the food safety management system. – The system of corporate governance guarantees independence of audits and corrective actions, root cause investigation of gaps and incidents and their reporting to the higher management. – A system of whistleblowing is established and personnel grievances as related to their work are followed up, investigated objectively and corrective actions are implemented. – The management is open to providing necessary resources or investment where needed, supporting testing of products, making recalls in case of incidents. – The management gives priority to consumer health over business interests. – The crisis manager, if different from the food safety team leader, is also identified and competent for his/her job. – All important decisions, instructions, reports of non-compliance or possible risks, follow-up and closing out of issues are well recorded and documented.
Product traceability, recall and crisis management, incident management
– An effective traceability system is in place at the factory. – It is possible to trace every consumer unit. – It is possible to identify all finished products manufactured from a given consignment of incoming material, including rework. – Traceability exercises are carried out regularly, at least once a year to ensure that the traceability system is effective. – A formal written procedure for product recall is available and the system is tested periodically. – A formal early warning, crisis management procedure and crisis committee are in place and the role and responsibilities of the members are specified. – Incidents are thoroughly investigated, root causes established and lessons learned from the incidents are disseminated across the organization to prevent their recurrence. – Senior management is engaged in incident debriefs and preventive action. (Continued)
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Elements of Food Safety Management Systems and Some Highlights of Issues to be Assessed TABLE 38.1 (Continued) Elements to be Assessed
Examples of Issues to be Considered During the Assessment
Raw materials and supplier management
– Supplier management is in place: suppliers are selected and approved based on their capability to ensure safety of the raw material and are periodically audited and monitored. – Suppliers are aware of the intended use of their products and of the regulatory requirements of the country where their product will be used or these are indicated in the specifications. – Supplier auditors have the appropriate experience and training to enable them to carry out a risk-based assessment at the supplier’s manufacturing location. – Raw materials (ingredients and packaging) have clear specifications and are signed to indicate agreement between the supplier and customer. – Certificates of analysis (where used) come from a laboratory that is able to competently test and samples are appropriately handled. The sensitivity of methods used are adequate for meeting the safety and regulatory requirements
Good hygienic practice (GHP)
– Incoming raw materials are inspected for their integrity authenticity and final goods are stored safely. – Warehouse management is in place, e.g. first in first out (FIFO) is respected, and raw material is properly labeled – Pest management is effective. – Adequate security measures are foreseen and visitors are screened for both health and security. – Housekeeping issues are respected, e.g. where applicable tools are labeled, chemicals are kept in a safe and secure location, identification (e.g. color coding) systems are used for tools, 5 S system is used for maintaining order. – Training of employees is comprehensive and validated for effectiveness of learning: personal health and hygienic behavior protocols are observed as verification that knowledge is being reinforced in the facility. Employee facilities for hygiene, such as lockers, bench barrier entryways (where needed) and hand-washing facilities are readily available. – Basic rules of food hygiene are also respected in canteens. – Buildings (including drains) are designed to minimize risks and meet hygienic requirements. Doors and windows are appropriately closed and screened. – Zoning (including air flow and the need of a filter) and flow of people are managed to minimize risk of cross-contamination throughout the facility. – Hygienic design of equipment and maintenance programs, including calibration of equipment, are followed rigorously according to the state of the art. – Food grade lubricants are used. – Industrial services are managed to maintain a safe production environment. – Cleaning procedures are correctly laid out, are valid and the implementation is verified. – Rejected raw material or final products are correctly handled and disposed of. – In case of maintenance work, the impact of the work is considered in risk and control measures. – Foreign matters are prevented through various measures and policies, such as glass-free policy, jewelry-free policy. – Consumers’, customers’ and regulatory authorities’ complaints are properly recorded and investigated and followed up in a timely manner. – Products are correctly labeled (content, visibility, clarity) and where consumers’ practice is critical for safety, the communication of safety information is validated for accuracy and clarity. – Before launching or modifying any product, it is ensured that regulatory or safety requirements are met. – Examination of the area, such as security measures for the premises and screening of visitors and subcontractors for security as well as their health status. (Continued)
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Elements of Food Safety Management Systems and Some Highlights of Issues to be Assessed TABLE 38.1 (Continued) Elements to be Assessed
Examples of Issues to be Considered During the Assessment
HACCP – Adequacy of the hazard analysis. All potential hazards are adequately identified and system and evaluated, and if this evaluation indicates the risk is insignificant, is this validated implementation by data? – Validity of control measures, i.e. the control measures eliminate or reduce the hazards to acceptable levels. – CCPs are identified, and critical limits are identified and operating within food safety and regulatory limits. Evidence should be obtained as to how these were determined, including the expertise used and any supportive document to validate these. – Evidence should be obtained that the monitoring of the critical limits indicates adequate control of the hazards. The adequacy of training in relation to personnel working at the CCPs and engaged in monitoring should also be considered, e.g. whether suitable instructions have been given to such personnel, and their role in relation to appropriate and timely actions. – An assessment as to whether the corrective actions would adequately restore control and are adequate to prevent an unsafe product from reaching the consumer. – An assessment of what, how, when and by whom the verification procedures have been undertaken, and whether these are adequate and effective. This may be indicated by an assessment of the validation data, sampling results, internal and external audit documentation as well as the frequency and thoroughness of all verification activities. The assessor should also consider whether changes, deficiencies in the HACCP plan, new emerging hazards, etc., are adequately provided for. Assessors should consider what actions are taken as a result of inadequacies in the HACCP plan or its prerequisites, or any other non-conformitya. – Additionally, assessors should consider whether records and documents are complete and in order. Where records indicate an issue or non-compliance, how these have been followed up. – The assessors should also evaluate the adequacy of the implementation, i.e. whether the HACCP plan and the prerequisites for HACCP have actually been implemented in the food business, maintained and are functioning correctly. – Root cause of CCP violations, or near miss investigations are carried out and short- and longterm corrective measures are in place. Verification activitiesa
– Internal audits are carried out regularly by a competent team; they cover all levels and aspects of the operations and unsatisfactory reports are subject to an investigation and root cause analysis. – Consumer complaint handling system is valid and is working effectively, i.e. personnel are trained in what to do, how to ask questions and they have the ability to connect different sets of information to detect a pattern or a cluster of non-compliances. – Suppliers are audited according to a risk-based program by a competent team. The results of the supplier audits, including the monitoring activities of the suppliers (e.g. their end-product testing), are considered in the hazard analysis and maintenance of the HACCP plan. – The assessment of GHP and equipment maintenance programs is carried out on a regular basis. – The system for recording consumer complaints is verified and it is ensured that it is working effectively. – The pathogen and environmental monitoring as well as raw- and end-product testing are carried out effectively and results are regularly reviewed and used for the validation of the GHP program, and also for the maintenance of the HACCP system. – Laboratories carrying out chemical and microbial testing are audited for good laboratory practice and are accredited. (Continued)
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Elements of Food Safety Management Systems and Some Highlights of Issues to be Assessed TABLE 38.1 (Continued) Elements to be Assessed Verification activitiesb
Examples of Issues to be Considered During the Assessment – HACCP teams receive the results of various verification activities. – Hazard analyses are reviewed based on the verification data and where necessary, e.g. a non-compliance or a change, the HACCP plan is revised accordingly. – A release procedure is in place for finished products and raw materials. – Senior management reviews the status of the food safety program, including reports of audits, incidents, consumer complaints or other non-compliances reported by the staff. – Periodic traceability, recall and crisis management exercises, or other verifications, are carried out in an effective manner.
a
Conformity means that activities are carried out according to the established procedures. This is part of the HACCP system; however, as described in Chapter 1, to highlight the importance of verification activities for the validation of the hazard analysis and maintenance of HACCP, they are mentioned separately. b
COMPETENCE OF ASSESSORS The validity of assessments depends to a great extent on the competencies of assessors 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 responsibility for protecting public health is significant. In any case, for a full scope assessment, the following competences, skills and qualifications need to be considered: The technical competence; The skills in assessing and investigating (audit skills); ● The interpersonal skills and values, i.e. communications skills, diplomacy, resilience, patience, self-discipline and open mindedness. In addition they need to be curious and analytical in how they should interpret what they observe; ● Finally, a good assessment requires the cooperation and openness of the assessment entity in providing truthful information. ● ●
Other factors such as time and financial constraints and availability of documents also play a significant role. With regard to technical knowledge, the following are needed at the very least: Understanding the basic hygienic requirements, their relevance in supporting safe food production, and experience in assessing them; ● Knowledge of laws, regulations, standards and general codes of hygiene and/or criteria for the specific category of products; ● Knowledge of relevant industry products and processes (including past failures in the category); ● Knowledge of the HACCP system and its application, including: ● The identification and assessment of potential hazards which may occur during food production, handling, preparation, storage and transportation, including biological, chemical and physical hazards; ●
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The ability to assess the effectiveness of control measures (validation) of the HACCP plan and its verification; ● Understanding the role of the human factor and of company culture in food safety. ●
THE PROCEDURE AND METHODOLOGY The procedure for an assessment must be defined and carried out in accordance with a set format. Assessors should ensure that they plan the process properly, i.e. that: ● ● ● ●
The scope of the assessment is predetermined and sufficient time is allocated; The required skills are available within the team; Tools needed are made available; Arrangements are communicated and agreed upon with the site being assessed. The procedures for assessment will need to include the following stages:
1. A planning process to prioritize establishments, operations and their frequency and scope of assessments; 2. A desktop assessment; 3. An on-site assessment; 4. An evaluation process to analyze findings, determine compliance and decide corrective actions and follow-up requirements; 5. Reporting and follow-up.
The Planning Process Initial planning is important to clarify the scope of the assessment and the approach that will be taken on-site. It helps to ensure that assessors have the necessary information and tools to complete an effective assessment. Information that will help in this planning process includes: Relevant company documentation; Previous file records, data on premises and products; and ● Results from previous visits or assessments. ● ●
The information obtained at this planning stage will also help to determine the focus of the assessment and the skills that might be necessary, particularly where assessments are carried out by a team. It also provides an opportunity to refine any checklist and protocols that might be used and, where appropriate, to communicate arrangements of the visits to the establishment. Any material such as camera, flashlight, tool kits, safety shoes, documentation and manuals can also be foreseen at this stage.
The Desktop Assessment The assessment itself is best carried out in two steps. The first stage, desktop assessment, consists of the initial review of documentation, which may be carried out on- or off-site.
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Although it is possible to carry out an assessment without a prior review of documentation, experience shows that a review of these prior to visiting the site leads to a more focused, thorough and informed assessment. A review of the documentation allows assessors to get an idea of the standards that are relevant to examine and become familiar with the site products and processes. It will give the assessors an opportunity to carry out some research to build up knowledge of the product technology, legislative control measures and/or industry standards. A desktop review also has the advantage of enabling assessors to plan their work, e.g. to judge how the CCPs have been established, check the personnel required for detailed discussions, review the specific questions to be asked, draw a list of priorities to focus on and/ or examine areas to visit during the on-site assessment. If the assessors find on the other hand that the document review has indicated obvious inadequacies, they may decide to stop the assessment at this point instead of proceeding to the on-site verification. Based on the findings, the assessors may decide to communicate to the company the type of measures which it needs to take. A review of the company documentation is best carried out off-site, particularly when government agencies are concerned. In some instances, there may be some constraints that make this difficult or impractical, for example where the assessment is of an urgent investigatory nature or where it is intended to be unannounced. However, even where this can only take place on-site, it is important to review and make use of relevant documentation prior to a further physical examination of the site premises, processes and procedures. A review of the flow diagram or site plan, for example, will provide information on the nature and scale of activities carried out. This will help to target the assessment, particularly the further necessary scrutiny of records, equipment and processes. Examples of documents to review: The food safety policy. The organigram, the responsibilities of the managers and food safety management team, and their respective technical expertise and competences. ● The operation and the type of products produced. ● The range and number of raw materials used and their origin. ● A site layout plan may give an idea of the flow of products through the site, the scale of the operation and the products produced. ● The HACCP-related documentation, including: ● A process flow diagram and specifications relating to it; ● The HACCP study (showing how potential hazards have been identified and on which basis they are considered as non-significant if this is the case); ● An HACCP plan, including the monitoring plan and the validation of the control measures; ● Records of CCP monitoring and corrective actions following the violation; ● Verification data, e.g. consumer complaints, monitoring data for raw material, environment or end products, reports of incidents and root cause analyses. ● Training programs, e.g. the manual or other tools used for training. ● Incident and crisis management procedures. ● ●
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Records of investigation and root cause analysis of incidents (both active and latent failures) as well as evidence of follow up and corrections of gaps and dissemination of lessons learned from the incidents. ● Reports of management review of food safety and quality. ●
Together with the type of products and operation, such information is crucial for planning the assessment, particularly of high risk products but also to gauge if the number of personnel and their qualifications are adequate to manage the safety of the products. Many organizations use a pre-assessment survey to organize the information required for this type of desktop assessment.
On-site Assessment The second stage is the on-site assessment. This will normally start with an initial or opening meeting to confirm, with the key people being assessed, the assessment scope, timetable, facilities and personnel required and in general to ensure cooperation. The time and location of the closing meeting could be confirmed and any additional documentation required for on-site document review could be requested at this stage. As a regulatory authority, inspections may be carried out unannounced. This has the advantage of examining the place and practices as they are on an everyday basis and of obtaining the best picture of the real practices. However, there is also a disadvantage in that appropriate personnel may not be available to answer questions or that the inspection may disrupt the workflow, which itself can create other opportunities for mistakes leading to risk for consumers. In an announced visit, it is helpful to prepare an agenda for the assessment program to ensure that relevant personnel are available during the assessment, and that their routine work is not disturbed more than it needs to be. The purpose of this step of the assessment is to confirm that procedures and practices described in the food safety management system of the company or the regulatory requirements to ensure food safety are properly implemented in practice. The scope of the assessment should have been decided during the planning stage. However, it could change depending on the findings of the on-site review of information, particularly if an off-site review (pre-assessment) was not done and the on-site assessment represents the first examination of the material. The scope of the assessment should also be changed during the assessment if serious non-compliance/deficiencies are seen. The on-site assessment will consist of a combination of activities. It should start with a review of the relevant documentation, their adequacy and accuracy. A special focus should be put on HACCP, understanding the flow diagram, the competence of the team, the hazard analysis and validity of the decision taken in the HACCP study. It will then move on to a physical examination of the processes, practices and records, by observation, measurement or interview to assess whether the actual operation in practice complies with the documented procedures. An important activity during this process is the evaluation of the state of prerequisite programs, including good hygienic practices
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according to the Codex General Principles of Hygiene or any other hygienic codes which may be applicable for the product or process in question. Such an examination will include the criteria listed earlier in Table 38.1. During the on-site visit, specific attention should be given to HACCP implementation, including: Confirming the accuracy of the process flow diagram(s). This is facilitated by an initial walk through the site. The assessor will subsequently need to engage in a range of questioning and investigative activities to assess the efficacy of the HACCP system. ● Evaluating the hazard analysis taking into consideration the state of the prerequisite programs mentioned above. ● Confirming the suitability of CCPs, critical limits and corrective actions. ● Confirming that monitoring schedules are established and operating correctly. ● Confirming 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. ● Establishing whether effective verification procedures are carried out. ● Reviewing monitoring data of raw materials, products, environment, CCPs, as well as reports of internal assessments, suppliers’ assessments (inclusive of supplier monitoring programs), consumer complaints, personal reports and complaints. It is particularly important to corroborate these results with the hazard analysis (for instance, if a contaminant is considered as not significant in the raw material, this is confirmed through the monitoring carried out for verification). ●
During these activities, the assessors will need to keep sufficiently 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 assessors, checks might be made on items of equipment, on-site measurements may be carried out, or product or environmental samples may be taken for subsequent laboratory analysis. Additionally, assessors may Carry out tests to verify the well functioning of the traceability system. Check awareness of the regulatory requirements of the country where products are produced and/or marketed. ● Evaluate the knowledge and training of key personnel in food safety in relation to the job they are required to do. ● Review the handling of non-compliances (incidents of food contamination) or complaints from the regulatory authorities. ● Examine the organization’s management structure to determine whether there are issues which may create conflict and undermine the reporting of non-compliances and/or investigation of incidents. The reporting system to ensure that top management is informed in a timely manner of food safety incidents or serious gaps in the company program, including managers’ attitude and behavior, is a critically important element. ● ●
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Evaluation Process Where the assessment is being carried out by a team and a range of skills are being utilized, the evaluation and conclusions drawn will need to be agreed in advance of any final meeting with the site representatives. The assessor (or the team) will need to identify and analyze all information obtained during the assessment in order to draw up preliminary conclusions of deficiencies found, if any, and their effect on food safety, regulatory compliance or other trade-related concerns. Assessors should use the findings of their investigations to evaluate the effect any deficiencies may have on food safety and the speed with which they would need to be rectified. The assessors(s) should evaluate findings based on objective evidence drawn from qualitative or quantitative information, records, statements, observations, measurements or tests which demonstrate that the prerequisites for HACCP or the HACCP system itself would not compromise food safety. Information and records gathered should be organized into a format that would support and justify the presentation of findings. It is beneficial to provide feedback on any positive findings of the assessment, where appropriate. This helps in presenting a balanced view. At the exit meeting, the assessor will need to discuss non-compliances/deficiencies and agree on the expected corrective actions. The approach taken at this stage will depend on the purpose of the assessment, for example when the assessment had been triggered off by a serious food safety problem or where the assessment was to exclude previously identified deficiencies. However, in all circumstances, it is preferable to present any findings in a methodical manner, specifically highlighting best practices as well as areas of critical noncompliance or deficiencies. The company should be given the opportunity to put forward its own solutions, as these may have substantial economic consequences such as capital expenditure, recruitment of new personnel, retraining of personnel or change of suppliers. A timeframe for corrective actions should be decided according to the importance of the gaps identified. At the conclusion of any assessment, the company should be clear on any immediate remedial action required. The remedial action should be communicated to the site representatives with the appropriate responsibility. In some cases, written assessment reports might only follow more detailed off-site evaluation of the findings by the assessor. However, in all cases, it is necessary for the assessors to engage in follow-up activities to ensure that reported non-conformance is rectified. The actions taken by government agencies where deficiencies are noted will depend on the nature of the identified deficiency, i.e. whether it is a non-conformance or a noncompliance. Some deficiencies will not have a direct impact on food safety. Assessors will need to have sufficient skills and competencies to evaluate the impact of deficiencies. Other factors which will influence the action taken will include evidence of a repetitive pattern suggesting insufficient control that could lead to an adverse food safety problem.
Reporting and Follow-up The format of assessor reports varies according to company policy and prior agreements with assessment bodies. However, it is essential that the results of the assessment be
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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 assessment 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 (see Chapter 37).
THE DEVELOPMENT AND USE OF A CHECKLIST Very often, to assess an operation assessors work from a checklist, i.e. a list of points to be considered during an assessment. Such a checklist is a useful tool for the assessment of the food safety management system provided that assessors are aware of its limitations and do not refrain from pursuing additional avenues of inquiry. Such a list has certain advantages and disadvantages (Table 38.2). A checklist should be designed so that a quantitative or qualitative measure of the evaluation can be recorded. An example of qualitative evaluation would be the use of the terms: “excellent, good, medium, and poor” or “critical, serious, major, minor.” Space should also be provided for written comments and objective evidence to be recorded next to each heading. The content of a checklist will depend upon the purpose of the specific assessment being undertaken and a specific checklist should be designed for each specific sector of the food chain. To facilitate their application, checklists should be supported by an assessment reference manual to guide the assessor in their correct and consistent application. As an example, a list of commonly used questions in regard to assessment of HACCP is provided below. It does not represent a comprehensive checklist; it intends to show how a list may look and the sort of questions and activities which may lead to an effective assessment (Table 38.3).
TABLE 38.2 Advantages and Limitations of a Checklist Concerns and Potential Misuse of Checklists
Advantages of Checklists – – – – – –
– – –
Function as an aide-memoire Help maintain the focus and objectivity of the assessment Act as a record of the assessment itself Ensure the completeness of the assessment Are a useful tool in ensuring consistency of approach between different assessors Help, together with associated reference manuals, to evaluate the comparability of different assessments, different companies or different assessors Ensure transparency of the assessment process Create confidence in the assessment process by all concerned, including government, industry and consumers Enable assessment data to be more easily entered into a database which, in turn, can be used for reporting and trend analysis
– If designed or used improperly, may restrict the initiative and judgment of the assessors and discourage critical thinking and evaluation – It is important that the use of a checklist not evolve into a simple “tick-box” approach where there is no critical evaluation – A checklist may be improperly designed so that it may include unnecessary or irrelevant items, or may omit critical points
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The Development and use of a Checklist
TABLE 38.3 An Example of Checklist for the Assessment of the HACCP System Preparatory activities
What evidence is there of management commitment to HACCP use? HACCP team – Who was on the team? – Are all disciplines relevant to the product in question represented? – What is the likely knowledge level of the individuals (evidence of training, qualifications, experience, etc.)? – Has external expertise been sought where necessary? – What is the decision-making leverage of the HACCP team leader? HACCP system – How does the system fit with the overall food safety management system? – Is HACCP included in the food safety policy? – Has the scope been clearly defined? – Are previous records of safety (e.g. incidents) known to the team? – Has the product been properly described? – Are intrinsic control measures identified? Process flow diagram (PFD) – Is the PFD comprehensive? – How was the PFD verified for accuracy and by whom? – Are all raw materials and process/storage activities included in the flow diagram? – Are there rework opportunities and have they been included? – Is the PFD correct? – Have changes been made since the PFD was drawn up? – How is the HACCP team notified of changes to the process or product parameters? – How were the changes recorded and approved? – Were any changes discussed with the HACCP team before implementation?
Principle 1 “Conducting a hazard analysis”
How was the hazard analysis conducted? – Have all raw materials (including rework) been included? – Have all process steps been considered? – Have the potential hazards been specifically identified by type/source or have they been generalized? – How did the team assess the likelihood of occurrence? – What information sources were utilized? – Where potential hazards have been considered as insignificant have these been validated? Have appropriate control measures (CMs) been identified for each hazard? – Will the CMs control the hazards to an acceptable level and how was this validated? – Have regulatory requirements been considered in making these decisions? – Are all the CMs in place at the plant level?
Principle 2 “Determining the Critical Control Points”
How were the CCPs identified? – By expert judgment? – By the use of a decision tree (has the decision tree been used correctly?)? – By the use of consultants? – Have all necessary CCPs been identified? – Did each identified hazard undergo a systematic consideration? – How are the hazards which are not controlled by CCPs addressed? (Continued)
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TABLE 38.3 38.3 (Continued) An Example of Checklist for the Assessment of the HACCP System TABLE Principle 3 “Establishing Critical Limits”
How were the critical limits established? – Have critical limits been established for each CCP? – What validation exists to confirm that the critical limits control the hazards identified? – Is there evidence (experimental data, literature references, etc.)? – How do they differ from operational limits?
Principle 4 “Establishing a system to monitor the control of the CCP”
Have realistic monitoring schedules been established? – Do they cover all CCPs? – Has the reliability of monitoring procedures been assessed where appropriate? – What is the status of monitoring equipment? – Is it evidenced as being in place and calibrated appropriately? – Are the CCP log sheets being used at all CCPs? – Have CCP log sheets been filled out correctly? – Is there any evidence that procedures are not being followed consistently? – Does the frequency of monitoring adequately confirm control? – Are the sampling plans statistically valid? – Are statistical process control records being used to demonstrate that the process is in control on a day-to-day basis? – Check that records agree with stated activities. Are monitoring personnel properly identified and trained? – How was the training undertaken? – Are the monitoring records being reviewed by designated appropriate reviewers? Are violations of CCPs investigated and root cause analysis made?
Principle 5 “Establishing the corrective action to be taken when monitoring indicates that a particular CCP is not under control”
– Have the corrective actions been properly defined so that control is regained? – What evidence is there to demonstrate that this is being done in the event of a CCP deviation? – Has corrective action been recorded and how is the effectiveness being verified? – How has the authority for corrective action been assigned? – How are non-conforming products controlled and is this clearly recorded? – Are there clear disposition actions listed?
Principle 6 “Establishing procedures for verification to confirm that the HACCP system is working effectively”
– – – – – – – – – – – – –
Have verification procedures been clearly and appropriately established? How are these procedures communicated through the business? Have responsibilities for verification procedures been allocated? Are they being carried out effectively? Are all CCPs covered by the verification program? Are hazards considered as non-significant validated through verification programs? Is there a formal system to trigger amendments? Are control parameters being achieved? Have process capability studies been carried out? How are the data from HACCP being used to improve the system? Are prerequisite support systems included within the verification program? How is consumer complaint data being used within the verification system? Is there a regular review of CCP failure and product dispositions? (Continued)
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An Example of Checklist for the Assessment of the HACCP System TABLE 38.3 (Continued) Principle 7 “Establishing documentation concerning all procedures and records appropriate to these principles and their application”
What format is being used to document the system? – Does the documentation cover all of the HACCP system operation, including: (1) the description of the product and its intended use, (2) the process flow diagram with the location of CCPs and related parameters available, (3) the HACCP worksheets on which are mentioned the hazards, the control measures, the CCPs, the critical limits, the monitoring procedures and the corrective actions, (4) data used for validation of hazard analysis, critical limits and monitoring parameters, corrective and verification activities, (5) the list of verification activities, (6) the results of monitoring and verification of the HACCP plan, and (7) the appropriate records necessary to ensure adequacy of prerequisite programs, particularly those used for validation of hazard analysis? – How is the documentation controlled with regard to update and issue, etc.? – Are the records accessible and are they clearly identified by unique reference numbers? – Are all documents accurate and current? – How is change control managed?
Implementation
Have the HACCP plan and the prerequisites for HACCP been implemented? – Personnel are trained in managing CCPs and know what to do when the CCPs are violated. – Personnel involved in verification activities and prerequisite activities are aware of the significance of their work for supporting the HACCP system and of the importance of reporting any non-compliance.
CONCLUSIONS Assessment of food safety management systems is an opportunity to improve food safety management and close the gaps. It should be carried out with objectivity and integrity. An unsatisfactory 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-term 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 sources of food safety problems are: ● ● ● ● ● ● ●
Raw material and supplier management. Failure in the design of equipment and its maintenance. GMP violation. Failure in hazard identification. CCP monitoring failure. Failure in corrective actions. Human negligence or error.
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Acknowledgment The authors would like to acknowledge that this chapter is based on personal experiences but also inspired from an earlier work, i.e. the FAO/WHO Expert Consultation that they convened on the subject of the Role of Government Agencies in Assessing HACCP (Geneva, 2–6 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 contribution 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.
Further Reading Dillon, M., Griffith, C. (Eds.), 2001. Auditing in the Food Industry. Woodhead Publishing in Food Science and Technology, Cambridge England. Campden, B.R.I., 2009. HACCP Auditing Standard, second ed. Campden BRI, UK. FAO/WHO Guidance on Regulatory Assessment of HACCP. Report of a Joint FAO/WHO Consultation on the role of Government Agencies in Assessing HACCP. Geneva, 2–6 June 1998, World Health Organization. FAO/WHO. Global Forum of Food Safety Regulators, Building effective food safety systems. Proceedings of the Forum 12–14 October 2004, Bangkok, Thailand. ISO. Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems. ISO/TS 22003:2007. International Standardization Organization, 2007.
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