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1 A hazard analysis shall be performed by the food safety team to determine the hazards to be controlled

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2 A hazard control plan shall be established, implemented and maintained

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3 A monitoring method shall be established at each CCP to detect any failure to remain within critical limits

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4 A monitoring method shall be established for each oPRP to detect failure to meet action criterion

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5 A risk management process shall be established

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6 Actions to address risks shall be planned

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7 Actions to address risks shall be proportionate to the impact on food safety requirements

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8 Actions to prevent the entry of dangerous products into the food chain shall be undertaken unless the food safety hazards have been reduced to acceptable levels defined

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9 All food safety statutory and regulatory requirements for end products shall be identified

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10 All food safety statutory and regulatory requirements for raw materials, ingredients and materials in contact with the product shall be identified

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11 All persons concerned shall be aware of the food safety policy

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12 All persons concerned shall be made aware of the importance of their contribution to the effectiveness of the FSMS

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13 All reasonably foreseeable food safety hazards shall be identified and documented

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14 An analysis of the verification results shall be conducted by the food safety team

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15 An audit program shall be planned, established, implemented and maintained

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16 Applicable statutory, regulatory and customer requirements shall be identified when selecting or developing PRPs

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17 Appropriate actions to identify and eliminate the causes of detected nonconformities shall be established and maintained as documented information

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18 Buildings and associated facilities shall be considered when developing PRPs

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19 Calibration and verification results shall be retained as documented information

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20 Control of external providers shall be maintained as documented information

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21 Corrections to nonconforming products and processes shall be retained as documented information

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22 Criteria for evaluation, selection and monitoring of external providers shall be established and applied

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23 Data from the monitoring of oPRPs and CCPs shall be evaluated by competent persons with authority to initiate corrections and corrective actions

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24 Decisions on opportunities for continual improvement shall be included in the output of the management review

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25 Documented information of external origin shall be approved

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26 Documented information of external origin shall be identified and controlled

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27 Documented information on food safety objectives shall be retained

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28 Documented information on raw materials, ingredients and materials in contact with the product shall be maintained

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29 Documented information on raw materials, ingredients and materials in contact with the product shall include the biological, chemical and physical characteristics

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30 Documented information to retain shall be protected from unintended alterations

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31 Each food safety hazard shall be assessed according to its probability of occurrence and the severity of its adverse effects

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32 Effective communication shall be established, implemented and maintained with the statutory and regulatory authorities

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33 Evaluation activities of external providers shall be retained as documented information

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34 Evidence of the appropriateness of the monitoring and measurement methods and equipment used shall be provided

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35 External and internal issues that influence the results of the FSMS shall be determined

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36 Flow diagrams shall include sequence and interaction of operating steps

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37 Flow diagrams shall include where raw materials, ingredients, processing aids, packaging materials, utilities and intermediate products enter the flow

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38 Food safety objectives shall be established at relevant functions and levels

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39 Food safety objectives shall be measurable

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40 Food safety objectives shall take into account food safety requirements

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41 Food safety team members shall be competent on the basis of appropriate education, initial training or relevant experience

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42 Food safety team members shall have multi-disciplinary knowledge and experience in the development and application of a FSMS

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43 FSMS changes shall be made on a planned basis

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44 Handling of emergencies and incidents shall include external communication

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45 Handling of emergencies and incidents shall include internal communication

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46 Information on interested parties shall be identified, reviewed and updated

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47 Information on the performance and effectiveness of the FSMS shall be taken into account during the management review

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48 Infrastructure needed for the FSMS shall be monitored

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49 Initial documented information shall be collected, maintained and updated for hazard analysis

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50 Intended use, unplanned use, misuse, expected handling and improper handling of the end product shall be maintained as documented information

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51 Intended use, unplanned use, misuse, expected handling and mishandling of the end product shall be taken into consideration

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52 Internal and external communication needs shall be determined

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53 Internal audits shall be performed at planned intervals

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54 Leadership and commitment of top management shall be demonstrated by ensuring that the resources required for the FSMS are available

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55 Leadership and commitment of top management shall be demonstrated by ensuring that food safety policy and objectives are established and consistent with the strategic direction of the organization

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56 Leadership and commitment of top management shall be demonstrated by promoting continual improvement

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57 Outsourced processes shall be controlled

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58 Planned and unintended changes shall be controlled

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59 Preventive measures against cross-contamination shall be taken into account when preparing PRPs

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60 Process description shall be maintained as documented information

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61 Process mapping shall be established and documented

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62 Product flow diagrams, categories and food safety processes shall be established, maintained and updated as documented information

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63 Products affected by failure to remain within critical limits at CCOs shall be handled as nonconforming products and shall not be released

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64 Provisions shall be in place to respond to potential emergencies or potential incidents

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65 PRPs shall be appropriate to the organization and its food safety context

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66 PRPs shall be approved by the food safety team

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67 PRPs shall be established, applied, maintained and updated

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68 Resources for maintaining the FSMS infrastructure shall be provided

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69 Resources for the maintenance of the FSMS working environment shall be determined, provided and maintained

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70 Resources needed for the establishment, implementation, maintenance, updating and continual improvement of the FSMS safety shall be determined and provided

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71 Responsibilities and role authorities shall be assigned, communicated and understood internally

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72 Results of the classification of control measures shall be maintained as documented information

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73 Risks shall be determined in order to enhance desirable effects

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74 Risks shall be determined to give assurance that the FSMS can achieve its intended results

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75 Risks shall be determined to reduce undesired effects

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76 Sufficient information shall be available to interested parties

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77 Sufficient information shall be provided externally

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78 The acceptable level of food safety hazards identified in the end product shall be determined

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79 The accuracy of the flow diagrams shall be confirmed in situ by the food safety team

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80 The application and effectiveness of withdrawals and recalls shall be kept as documented information

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81 The characteristics of the end products shall be updated, if necessary, after establishing the hazard control plan

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82 The corrections and critical actions to be taken shall be specified when critical limits or action criterion are not met in order to identify the cause of nonconformity

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83 The disposition of nonconforming products shall be retained as documented information

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84 The distribution of the end product shall be taken into account when establishing and applying the traceability system

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85 The documented information on the characteristics of end products shall include the intended shelf life and storage conditions

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86 The documented information on the characteristics of the end products shall include the product name and the biological, chemical and physical characteristics

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87 The documented information required by the statutory authorities, the regulatory authorities and by the customers shall be included in the FSMS

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88 The documented information shall be reviewed and, if necessary, updated after the occurrence of an incident or emergency

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89 The documented information that the organization deems necessary for the effectiveness of the FSMS shall be included in the FSMS

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90 The effectiveness of the traceability system shall be verified and tested

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91 The externally provided FSMS elements shall be developed in accordance with the requirements of ISO 22000

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92 The externally provided FSMS elements shall be retained as documented information

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93 The food safety manual shall be approved by top management

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94 The food safety policy shall be appropriate to the purpose and context of the organization

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95 The food safety policy shall be communicated only internally

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96 The food safety policy shall be communicated, understood and applied internally

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97 The food safety policy shall be established, implemented, maintained

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98 The food safety policy shall provide a framework for setting food safety objectives

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99 The food safety team leader shall report on the effectiveness of the FSMS to top management

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100 The food safety team shall be informed in a timely manner of any changes made to customer requirements

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101 The food safety team shall be informed in good time about changes made to products and raw materials

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102 The FSMS and the necessary processes and their interactions shall be established, applied, maintained, updated and improved continually

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103 The FSMS shall be updated continually

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104 The FSMS update activities shall be included as input to the management review

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105 The hazard control plan shall be applied and maintained

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106 The identification and description of the documented information shall be ensured when it is created and updated

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107 The limits and applicability of the FSMS shall be determined

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108 The management review shall be maintained as documented information

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109 The necessary resources shall be determined when planning how the food safety objectives will be achieved

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110 The performance and effectiveness of the FSMS shall be evaluated

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111 The persons necessary to operate and maintain an effective FSMS shall be competent

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112/132

112 The processes necessary to meet the requirements of safe products shall be planned, implemented, controlled, maintained and updated

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113 The purpose of the changes and their consequences shall be taken into account

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114 The rationale for determining critical limits at CCPs and action criteria for oPRPs shall be maintained as documented information

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115 The responsibility and authority of the food safety team shall be assigned by top management

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Quiz requirements ISO 22000 version 2018

116/132

116 The results of any corrective action taken shall be retained as documented information

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Quiz requirements ISO 22000 version 2018

117/132

117 The results of monitoring and measurement shall be analyzed and evaluated

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Quiz requirements ISO 22000 version 2018

118/132

118 The scope of the FSMS shall be available and maintained as documented information

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Quiz requirements ISO 22000 version 2018

119/132

119 The scope of the SFMS shall include the processes, products and services that can influence the food safety of the end products

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Quiz requirements ISO 22000 version 2018

120/132

120 The selected control measures shall be classified as oPRP or CCP

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Quiz requirements ISO 22000 version 2018

121/132

121 The selected control measures shall be validated by the food safety team

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Quiz requirements ISO 22000 version 2018

122/132

122 The steps at which food safety hazards can be present, introduced, increased or persisted shall be identified

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Quiz requirements ISO 22000 version 2018

123/132

123 The suitability, adequacy and effectiveness of the FSMS shall be continually improved

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124/132

124 The withdrawal and recall of any lot of end products identified as hazardous shall be guaranteed by appointing the person with the authority to do so

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Quiz requirements ISO 22000 version 2018

125/132

125 Top management shall review the FSMS at planned intervals

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Quiz requirements ISO 22000 version 2018

126/132

126 Validation activities of software used for monitoring and measurement shall be maintained as documented information

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Quiz requirements ISO 22000 version 2018

127/132

127 Verification activities shall not be performed by the person responsible for monitoring these activities

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Quiz requirements ISO 22000 version 2018

128/132

128 Verification of PRPs and hazard control plan shall be established, implemented and maintained

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129/132

129 What needs to be monitored and measured shall be determined

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Quiz requirements ISO 22000 version 2018

130/132

130 When a nonconformity occurs, responsible persons shall react to the nonconformity and deal with the consequences

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Quiz requirements ISO 22000 version 2018

131/132

131 When action criteria for oPRPs are not met the food safety consequences of this failure shall be determined

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Quiz requirements ISO 22000 version 2018

132/132

132 When the critical limits at CCPs or action criteria for oPRPs are not met, the products concerned shall be identified and their use and release controlled

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Quiz requirements ISO 22000 version 2018