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HACCPHACCPالحرجة الضبط لنقاط المخاطر تحليل الحرجة نظام الضبط لنقاط المخاطر تحليل نظام

) ومتطلباته) ( الهسب ومتطلباته) الهسبHazard Analysis of Critical Control Points Hazard Analysis of Critical Control Points

(HACCP)(HACCP)

الساعد يوسف كامل علي الساعد الدكتور يوسف كامل علي الدكتور

الغذائي والتصنيع التغذية الغذائي قسم والتصنيع التغذية قسم

/ / األردن ،عمان األردنية الجامعة الزراعة /كلية / األردن ،عمان األردنية الجامعة الزراعة كلية

00962653550000096265355000هاتف المكتب:هاتف المكتب:2241322413داخليداخلي

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CONTENTSCONTENTS 11 INTRODUCTION 4INTRODUCTION 4 22 SCOPE of APPLICATION 7SCOPE of APPLICATION 7 33 REFERENCE DOCUMENTS 8REFERENCE DOCUMENTS 8 44 TERMS and DEFINITIONS 9TERMS and DEFINITIONS 9 55 HACCP SYSTEM REQUIREMENTS 12HACCP SYSTEM REQUIREMENTS 12 5.15.1 Management responsibilityManagement responsibility 12 12 5.1.1 5.1.1 PolicyPolicy 5.1.2 5.1.2 Scope of the HACCP systemScope of the HACCP system 5.1.3 5.1.3 Task, Responsibilities, AuthoritiesTask, Responsibilities, Authorities 5.1.4 5.1.4 HACCP team(s)HACCP team(s) 5.1.5 5.1.5 ResourcesResources 5.1.6 5.1.6 Management reviewManagement review

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5.25.2 Product InformationProduct Information 1414 5.2.1 5.2.1 Product CharacteristicsProduct Characteristics

5.2.2 5.2.2 Intended useIntended use5.35.3 Process InformationProcess Information 1515

5.3.15.3.1 Flow DiagramsFlow Diagrams5.3.25.3.2 LayoutLayout

5.3.35.3.3 Control and Verification of Processing Control and Verification of Processing informationinformation 5.45.4 Pre-requisite program Pre-requisite program 1616

5.55.5 Hazard Analysis Hazard Analysis 1717 5.5.15.5.1 Hazard identification Hazard identification

5.5.25.5.2 HACCP analysis (risk)HACCP analysis (risk) 5.65.6 Control MeasuresControl Measures 19 19

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5.6.1 Specific Control Measures 5.6.1 Specific Control Measures 5.6.2 General Control Measures 5.6.2 General Control Measures 5.75.7 Parameters and Critical Limits Parameters and Critical Limits 5.7.1 Critical process and product parameters5.7.1 Critical process and product parameters 5.7.2 Target values, action-limit values 5.7.2 Target values, action-limit values and critical limitsand critical limits 5.85.8 Monitoring and Measuring Monitoring and Measuring

5.95.9 Corrective Actions Corrective Actions 5.10 Validation 5.10 Validation 5.11 Verification5.11 Verification 5.12 Documentation and records5.12 Documentation and records 5.12.1 Documents and document control5.12.1 Documents and document control 5.12.2 Records5.12.2 Records

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1 INTRODUCTION Reference documents; legislation; background

information Food safety is a global concern. Not only

because of the continuing importance for public health, but also because of its impact on international trade.

Effective Food Safety Systems shall therefore manage and ensure the safety and suitability of foodstuffs.

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• In many countries world-wide, legislation on the safety In many countries world-wide, legislation on the safety and suitability of foodstuffs requires “HACCP” to be put and suitability of foodstuffs requires “HACCP” to be put in place by any food business or organisation, whether in place by any food business or organisation, whether profit-making or not and whether public or private, profit-making or not and whether public or private, carrying out any or all of the following activities:carrying out any or all of the following activities:

preparation, preparation, processing, processing, manufacturing, manufacturing, packaging, packaging, storage, storage, transportation, transportation, distribution, distribution, handling or offering for sale or supply of foodstuffs. handling or offering for sale or supply of foodstuffs.

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According to EU Directive 93/43/EEC on According to EU Directive 93/43/EEC on Food Hygiene all food business operators in Food Hygiene all food business operators in the European Union shall implement HACCP the European Union shall implement HACCP [1][1]. They shall ensure that adequate safety . They shall ensure that adequate safety procedures are identified, documented, procedures are identified, documented, maintained and reviewed on the basis of the maintained and reviewed on the basis of the principles used to develop the system of principles used to develop the system of HACCP (“Hazard Analysis and Critical HACCP (“Hazard Analysis and Critical Control Point”).Control Point”).[1][1] EU Directive 93/43/EEC on the EU Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175).(PbEC L175).

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The Joint FAO/WHO Codex Alimentarius The Joint FAO/WHO Codex Alimentarius Commission describes a series of steps, Commission describes a series of steps, including the 7 HACCP principles giving including the 7 HACCP principles giving guidance for the application of the HACCP guidance for the application of the HACCP system system [1][1]..

Also, Codex advises that minimum hygiene Also, Codex advises that minimum hygiene measures should be in place before HACCP is measures should be in place before HACCP is implemented: ”Prior to application of HACCP implemented: ”Prior to application of HACCP to any sector of the food chain, that sector to any sector of the food chain, that sector should be operating according to the Codex should be operating according to the Codex General Principles of Food Hygiene, the General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate Codex Codes of Practice, and appropriate food safety legislation.”appropriate food safety legislation.”

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Figure 1. The structure, the sequence and interaction of the Figure 1. The structure, the sequence and interaction of the assessment processassessment process for a HACCP based Food Safety Systemfor a HACCP based Food Safety System

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22 SCOPE of APPLICATIONSCOPE of APPLICATION In this document, requirements have been In this document, requirements have been

specified to be used during the assessment of specified to be used during the assessment of operational HACCP systems (HACCP-based operational HACCP systems (HACCP-based Food Safety Systems) which ensure the safety Food Safety Systems) which ensure the safety of foodstuffs during preparation, processing, of foodstuffs during preparation, processing, manufacturing, packaging, storage, manufacturing, packaging, storage, transportation, distribution, handling or offering transportation, distribution, handling or offering for sale or supply in any sector of the food for sale or supply in any sector of the food chain.chain.

The “Requirements” are basically applicable to The “Requirements” are basically applicable to all food businesses or organisations, whether all food businesses or organisations, whether profit-making or not, and whether public or profit-making or not, and whether public or private.private.

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Figure 2:Figure 2: Summary of the Codex General Summary of the Codex General

Principles of Food Hygiene (CAC/RCP 1-1969, Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3 (1997), Amended 1999)Rev. 3 (1997), Amended 1999)

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5.95.9 Corrective Actions Corrective Actions For each Critical Control Point, the food business For each Critical Control Point, the food business

operator shall document the corrective actions to operator shall document the corrective actions to be taken in case an action-limit value or critical be taken in case an action-limit value or critical limit is exceeded. limit is exceeded.

The procedure will include the process to The procedure will include the process to investigate the cause of the deviation.investigate the cause of the deviation.

A documented justification for the corrective A documented justification for the corrective action to be taken shall be available, including the action to be taken shall be available, including the responsibilities and authorities of the personnel responsibilities and authorities of the personnel which is involved. which is involved.

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The actions to be taken must be established in The actions to be taken must be established in advance. This could also involve the formation of advance. This could also involve the formation of a so-called 'emergency team'. a so-called 'emergency team'.

This team shall evaluate the causes of the This team shall evaluate the causes of the deviation and shall decide which additional deviation and shall decide which additional preventive actions are to be taken (see also section preventive actions are to be taken (see also section 5.11).5.11).

The food business operator shall also establish The food business operator shall also establish arrangements that provide procedures for recall of arrangements that provide procedures for recall of the products from the market place and/or from the products from the market place and/or from end consumers.end consumers.

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Proper product identification and a “tracing & Proper product identification and a “tracing & tracking” system shall be operational.tracking” system shall be operational.

All corrective actions taken, the causes and All corrective actions taken, the causes and consequences, and the individuals involved in consequences, and the individuals involved in the corrective actions shall be recorded.the corrective actions shall be recorded.

The effectiveness of the corrective actions, for The effectiveness of the corrective actions, for both the process and the product, shall be both the process and the product, shall be evaluated.evaluated.

Products resulting from the process while the Products resulting from the process while the critical limit has been exceeded shall be treated critical limit has been exceeded shall be treated as non-conforming products. as non-conforming products.

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The corrective actions may include:The corrective actions may include: With respect to the product:With respect to the product: Actions ranging from blockades to product recall; Actions ranging from blockades to product recall; Temporary hold of the product/batch;Temporary hold of the product/batch; Identification of non-conforming products;Identification of non-conforming products; Re-work of the product;Re-work of the product; Disposal/destruction of the product/batch.Disposal/destruction of the product/batch. With respect to the process:With respect to the process: Adjusting the process;Adjusting the process;

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5.105.10 ValidationValidation Validation is not a part of verification, but a Validation is not a part of verification, but a

separate activity prior to authorising the HACCP separate activity prior to authorising the HACCP plan plan [1][1]..

The objective of validation is to ensure that the The objective of validation is to ensure that the hazards originally identified by the HACCP team hazards originally identified by the HACCP team are complete and correct and that they will be are complete and correct and that they will be effectively controlled under the proposed plan. effectively controlled under the proposed plan.

To meet the objectives of validation it is To meet the objectives of validation it is necessary to review the effectiveness of the necessary to review the effectiveness of the supporting evidence used in the HACCP study as supporting evidence used in the HACCP study as well as the general and specific control measures, well as the general and specific control measures, the monitoring system and corrective actions.the monitoring system and corrective actions.

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Each time when the food business operation Each time when the food business operation changes in a manner that could adversely affect changes in a manner that could adversely affect food safety this review shall be up-dated. food safety this review shall be up-dated.

To ensure absence of bias, the food business To ensure absence of bias, the food business operator shall form a validation team. operator shall form a validation team.

The validation team may include members of the The validation team may include members of the HACCP team, but must also include independent HACCP team, but must also include independent reviewers e.g. from within the food business reviewers e.g. from within the food business operation, who have not been directly involved in operation, who have not been directly involved in the establishment of the HACCP plan. the establishment of the HACCP plan.

Validation is performed by demonstrating that:Validation is performed by demonstrating that:

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The established list of potential hazards The established list of potential hazards is is based on sound scientific data and has included based on sound scientific data and has included all hazards;all hazards;

The questions used to assess the significance are The questions used to assess the significance are answered using sound scientific and technical answered using sound scientific and technical knowledge;knowledge;

The control measures (general or specific) are The control measures (general or specific) are appropriate to control the hazards, i.e. to prevent or appropriate to control the hazards, i.e. to prevent or eliminate, to reduce or maintain at an acceptable eliminate, to reduce or maintain at an acceptable level;level;

Fluctuations of the control parameters (equivalent Fluctuations of the control parameters (equivalent to a process criterion) within the defined critical to a process criterion) within the defined critical limits will not affect the safety of the product;limits will not affect the safety of the product;

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The parameters and methods used to monitor the The parameters and methods used to monitor the control measures are appropriate;control measures are appropriate;

Corrective actions are appropriate and will prevent Corrective actions are appropriate and will prevent the release of unsafe products and provide evidence the release of unsafe products and provide evidence that the situation can be corrected immediately.that the situation can be corrected immediately.

Food business operators may have produced safe Food business operators may have produced safe food for many years before the introduction of the food for many years before the introduction of the HACCP system. HACCP system.

Therefore, historical results from on-line Quality Therefore, historical results from on-line Quality Control monitoring, end product testing, customer Control monitoring, end product testing, customer or consumer complaints may be used as evidence or consumer complaints may be used as evidence when validating HACCP plans. when validating HACCP plans.

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It is important to note that the data must be It is important to note that the data must be quantifiable and objective if it is to be useful.quantifiable and objective if it is to be useful.

The composition of the validation team and the The composition of the validation team and the activities undertaken shall be clearly documented. activities undertaken shall be clearly documented.

The food business operator shall demonstrate The food business operator shall demonstrate satisfactory completion of validation.satisfactory completion of validation.

5.11 5.11 VerificationVerification The food business operator shall establish, The food business operator shall establish,

document and implement procedures for document and implement procedures for verification of the HACCP system. verification of the HACCP system.

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The main purpose of verification is to determine The main purpose of verification is to determine compliance with the specifications of the HACCP compliance with the specifications of the HACCP system and to confirm that the HACCP system is system and to confirm that the HACCP system is working effectively through the application of working effectively through the application of (auditing) methods, procedures, tests (including (auditing) methods, procedures, tests (including random sampling and analysis) and other random sampling and analysis) and other evaluations, in addition to monitoring (see section evaluations, in addition to monitoring (see section 5.8).5.8).

Procedures for verification shall be documented Procedures for verification shall be documented and shall include as a minimum:and shall include as a minimum:

Purpose;Purpose; Methods, standard operating procedures or tests Methods, standard operating procedures or tests

applied;applied;

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Tasks and responsibilities;Tasks and responsibilities; Frequency;Frequency; Records.Records. The verification procedure shall address, as a The verification procedure shall address, as a

minimum, the following topics:minimum, the following topics: Review of the HACCP system and its Review of the HACCP system and its

corresponding records;corresponding records; Analysis of (near) recalls and product Analysis of (near) recalls and product

dispositions;dispositions; Assessment of all specific control measures, Assessment of all specific control measures,

deviations and corrective actions taken to seek deviations and corrective actions taken to seek confirmation of implementation and effective confirmation of implementation and effective control of CCP's;control of CCP's;

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Assessment of all general control measures to seek Assessment of all general control measures to seek confirmation of implementation and to demonstrate confirmation of implementation and to demonstrate an effective control of associated hazards;an effective control of associated hazards;

Compliance of the actual flow diagrams and layout Compliance of the actual flow diagrams and layout with the documented situation;with the documented situation;

Compliance of the PRP documents with the Compliance of the PRP documents with the operational situation;operational situation;

Analysis of customer and consumer complaints Analysis of customer and consumer complaints related to hygiene and food safety;related to hygiene and food safety;

Review of analytical outcome of random sampling Review of analytical outcome of random sampling and analysis of products;and analysis of products;

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Evaluation of conformity with applicable Evaluation of conformity with applicable legislation and regulations (as well as conformity legislation and regulations (as well as conformity to foreseeable changes in legislation and to foreseeable changes in legislation and regulations) and identification of changes in regulations) and identification of changes in legislation and regulations concerning food safety;legislation and regulations concerning food safety;

Review of gaps between current and desired level Review of gaps between current and desired level of knowledge, awareness and training of staff with of knowledge, awareness and training of staff with respect to hygiene and food safety, resulting in respect to hygiene and food safety, resulting in effective (on-the-job) training sessions;effective (on-the-job) training sessions;

Consistency of the current documentation.Consistency of the current documentation.

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Internal auditInternal audit The food business operator shall determine The food business operator shall determine

whether the HACCP system:whether the HACCP system: Conforms with the planned arrangements: Conforms with the planned arrangements: with the “Requirements for a HACCP-based Food with the “Requirements for a HACCP-based Food

Safety System” and Safety System” and with the requirements established by the food with the requirements established by the food

business operator itself.business operator itself. Is effectively implemented and maintained.Is effectively implemented and maintained. The food business operator shall plan an internal The food business operator shall plan an internal

audit scheme, taking into consideration the status audit scheme, taking into consideration the status and importance of the processes and areas to be and importance of the processes and areas to be audited, as well as the results of previous audits.audited, as well as the results of previous audits.

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The audit criteria, scope, frequency and methods The audit criteria, scope, frequency and methods shall be defined, taking into consideration the shall be defined, taking into consideration the status and importance of the processes and area’s status and importance of the processes and area’s to be audited, as well as the results of previous to be audited, as well as the results of previous audits. audits.

Selection of auditors and the conduct of audits Selection of auditors and the conduct of audits shall ensure objectivity and impartiality of the shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own audit process. Auditors shall not audit their own work.work.

The responsibilities and requirements for planning The responsibilities and requirements for planning and conducting audits, for reporting results and and conducting audits, for reporting results and maintaining records shall be defined in a maintaining records shall be defined in a documented procedure.documented procedure.

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Management reviewManagement review The food business operator shall review and The food business operator shall review and

evaluate the results of the entire verification evaluate the results of the entire verification process at planned intervals, of no more than 12 process at planned intervals, of no more than 12 months (see par. 5.1.6). months (see par. 5.1.6).

Therefore, the frequency of verification and Therefore, the frequency of verification and internal audits shall be such that the food internal audits shall be such that the food business operator can ensure continuing business operator can ensure continuing suitability, adequacy and effectiveness of the suitability, adequacy and effectiveness of the HACCP-based Food Safety System. HACCP-based Food Safety System.

Some requirements are to be verified with a Some requirements are to be verified with a higher frequency than other requirements. higher frequency than other requirements.

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For instance, the effective control of CCP’s (5.6.1) For instance, the effective control of CCP’s (5.6.1) may be evaluated with a frequency of at least may be evaluated with a frequency of at least twice a year, whereas a frequency of once a year twice a year, whereas a frequency of once a year may be sufficient to verify the actuality of process may be sufficient to verify the actuality of process lines and layout (5.3.3).lines and layout (5.3.3).

The food business operator shall collect and The food business operator shall collect and analyse the resulting data to evaluate where analyse the resulting data to evaluate where improvement is needed. improvement is needed.

The food business operator shall ensure that The food business operator shall ensure that preventive actions (see 5.9) are taken without preventive actions (see 5.9) are taken without undue delay to eliminate the causes of (potential) undue delay to eliminate the causes of (potential) non-conformities in order to prevent recurrence non-conformities in order to prevent recurrence (occurrence). (occurrence).

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The preventive actions shall be appropriate to the The preventive actions shall be appropriate to the effects of the (potential) non-conformities effects of the (potential) non-conformities encountered. encountered.

The effectiveness of the preventive actions taken The effectiveness of the preventive actions taken shall be validated. shall be validated.

Follow-up actions shall include the verification Follow-up actions shall include the verification and review of actions taken.and review of actions taken.

[1][1] In the document “Hazard Analysis and Critical In the document “Hazard Analysis and Critical Control Point (HACCP) system and guidelines for Control Point (HACCP) system and guidelines for its application” (Annex to CAC/RCP 1 –1969, its application” (Annex to CAC/RCP 1 –1969, Rev.3, 1997) Codex Alimentarius Commission Rev.3, 1997) Codex Alimentarius Commission include validation as a part of verification.include validation as a part of verification.

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There is, however, a clear distinction between the There is, however, a clear distinction between the two because they are separate actions. two because they are separate actions.

The distinction lies in justifying what a food The distinction lies in justifying what a food business operator plans to do (validation) andbusiness operator plans to do (validation) and

then checking conformity with the planned then checking conformity with the planned actions and objectives (verification).actions and objectives (verification).

Validation is an essential part of the HACCP Validation is an essential part of the HACCP process. process.

It is concerned with obtaining objective evidence It is concerned with obtaining objective evidence that the elements of the HACCP plan will be that the elements of the HACCP plan will be effective. effective.

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Validation should be targeted at the assessment of the Validation should be targeted at the assessment of the scientific and technical inputs into the HACCP plan; scientific and technical inputs into the HACCP plan;

it should ensure that the information supporting the it should ensure that the information supporting the HACCP plan is correct; HACCP plan is correct;

that the food business operator is “going to do the that the food business operator is “going to do the right things”. right things”.

Validation needs to be performed before approval of Validation needs to be performed before approval of the HACCP plan by the food business operator and the HACCP plan by the food business operator and before its implementation.before its implementation.