ISO 22000 2018 TRANSLATED INTO PLAIN ENGLISH
8. OPERATIONS
8.1 ESTABLISH PROCESSES NEEDED TO REALIZE SAFE PRODUCTS
1 Plan operational processes needed to meet food safety requirements. DO DN NA
2 Plan internal processes needed to meet food safety requirements. DO DN NA
3 Develop internal processes needed to meet safety requirements. DO DN NA
4 Establish criteria that your internal processes must meet. DO DN NA
5 Use your criteria to develop internal process controls. DO DN NA
6 Consider actions to address food safety risks and opportunities. DO DN NA See section 6.1, above.
7 Make these actions an integral part of your operational processes. DO DN NA
8 Document internal processes needed to meet safety requirements. DO DN NA
9 Implement operational processes needed to meet food safety requirements. DO DN NA
10 Implement internal processes needed to meet food safety requirements. DO DN NA
11 Use your process criteria to control your operational processes. DO DN NA
12 Control operational processes needed to meet food safety requirements. DO DN NA
13 Control internal processes needed to meet food safety requirements. DO DN NA
14 Use documents to show that processes are carried out as planned. DO DN NA
15 Control outsourced processes needed to meet food safety requirements. DO DN NA See section 7.1.6, above.
16 Maintain operational processes needed to meet food safety requirements. DO DN NA
17 Maintain internal processes needed to meet food safety requirements. DO DN NA
18 Maintain and retain suitable food safety documents and records. DO DN NA
19 Update operational processes needed to meet food safety requirements. DO DN NA
20 Update internal processes needed to meet food safety requirements. DO DN NA
21 Control planned changes to processes used to realize products. DO DN NA
ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
JULY 2019 PLAIN ENGLISH FOOD SAFETY MANAGEMENT STANDARD EDITION 1.0
PART 8 COPYRIGHT © 2019 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 76
ISO 22000 2018 TRANSLATED INTO PLAIN ENGLISH
8. OPERATIONS
22 Review the consequences of unintended changes in process. DO DN NA
23 Take action to mitigate adverse effects (when necessary). DO DN NA
8.2 ESTABLISH SUITABLE PREREQUISITE PROGRAMMES (PRPs)
8.2.1 MAKE SURE THAT PREREQUISITE PROGRAMMES ARE DEVELOPED
24 Prevent or reduce product contamination by developing PRPs. DO DN NA Prerequisite programs
(PRPs) are the conditions
that must be established
25 Prevent or reduce product contamination by implementing PRPs. DO DN NA throughout the food chain
and the activities and
practices that must be
26 Use your organization's PRPs to control food safety hazards. DO DN NA performed in order to
ensure that food products
are safe. PRPs must be
27 Use your organization's PRPs to establish suitable environments. DO DN NA suitable and be capable
of producing safe end
products and providing
28 Use your PRPs to establish a suitable processing environment. DO DN NA food that is safe for
human consumption.
29 Use your PRPs to establish an appropriate work environment. DO DN NA
30 Prevent or reduce product contamination by maintaining PRPs. DO DN NA
31 Prevent or reduce product contamination by updating PRPs. DO DN NA
8.2.2 MAKE SURE THAT PREREQUISITE PROGRAMMES ARE IMPLEMENTED
32 Establish your organization's prerequisite programmes (PRPs). DO DN NA
33 Authorize your organization's prerequisite programmes (PRPs). DO DN NA
34 Make sure that PRPs have been approved by the food safety team. DO DN NA
35 Make sure that PRPs are appropriate in your unique circumstances. DO DN NA
36 Make sure that these PRPs take your specific products into consideration. DO DN NA
37 Make sure that these PRPs take your type of operation into consideration. DO DN NA
38 Make sure that these PRPs take your organization's size into consideration. DO DN NA
39 Implement these PRPs throughout your entire production system. DO DN NA
40 Implement general PRPs or specific PRPs that apply to a specific product or process. DO DN NA
ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
JULY 2019 PLAIN ENGLISH FOOD SAFETY MANAGEMENT STANDARD EDITION 1.0
PART 8 COPYRIGHT © 2019 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 77
ISO 22000 2018 TRANSLATED INTO PLAIN ENGLISH
8. OPERATIONS
8.2.3 MAKE SURE THAT PREREQUISITE PROGRAMMES ARE ACCEPTABLE
41 Consider external requirements as you develop your organization's PRPs. DO DN NA
42 Consider relevant legal requirements when you develop your PRPs. DO DN NA
43 Consider regulatory requirements when you develop your PRPs. DO DN NA
44 Consider statutory requirements when you develop your PRPs. DO DN NA
45 Consider relevant customer requirements when you develop your PRPs. DO DN NA
46 Consider relevant industry requirements when you develop your PRPs. DO DN NA
47 Consider all relevant standards, guidelines, and codes of practice. DO DN NA
48 Consider applicable parts of ISO/TS 22002 on food safety PRPs. DO DN NA
8.2.4 MAKE SURE THAT PREREQUISITE PROGRAMMES ARE SUITABLE
49 Ensure that your PRPs are appropriate to your circumstances. DO DN NA
50 Consider your organization's situation as you establish PRPs. DO DN NA
51 Consider your consumers as you establish your PRPs. DO DN NA
52 Consider what consumers know about your products. DO DN NA
53 Consider contaminants as you establish your PRPs. DO DN NA
54 Consider the need to prevent cross-contamination. DO DN NA
55 Consider your processes as you establish your PRPs. DO DN NA
56 Consider sanitation as you establish your PRPs. DO DN NA
57 Consider cleaning and disinfecting practices. DO DN NA
58 Consider personal hygiene habits and routines. DO DN NA
59 Consider pest control practices and procedures. DO DN NA
60 Consider external inputs as you establish your PRPs. DO DN NA
ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
JULY 2019 PLAIN ENGLISH FOOD SAFETY MANAGEMENT STANDARD EDITION 1.0
PART 8 COPYRIGHT © 2019 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 78
ISO 22000 2018 TRANSLATED INTO PLAIN ENGLISH
8. OPERATIONS
61 Consider incoming materials as you establish PRPs. DO DN NA
62 Consider how incoming materials are received. DO DN NA
63 Consider how incoming materials are handled. DO DN NA
64 Consider how incoming materials are stored. DO DN NA
65 Consider how incoming materials are dispatched. DO DN NA
66 Consider how incoming materials are transported. DO DN NA
67 Consider incoming products as you establish PRPs. DO DN NA
68 Consider how incoming products are received. DO DN NA
69 Consider how incoming products are handled. DO DN NA
70 Consider how incoming products are stored. DO DN NA
71 Consider how incoming products are dispatched. DO DN NA
72 Consider how incoming products are transported. DO DN NA
73 Consider your infrastructure as you establish PRPs. DO DN NA
74 Consider buildings as you establish your PRPs. DO DN NA
75 Consider the lay-out of your buildings. DO DN NA
76 Consider how your buildings are constructed. DO DN NA
77 Consider layout of premises as you establish PRPs. DO DN NA
78 Consider your organization’s workspaces. DO DN NA
79 Consider your employee facilities. DO DN NA
80 Consider your equipment as you establish PRPs. DO DN NA
81 Consider the suitability of your equipment. DO DN NA
82 Consider the accessibility of your equipment. DO DN NA
ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
JULY 2019 PLAIN ENGLISH FOOD SAFETY MANAGEMENT STANDARD EDITION 1.0
PART 8 COPYRIGHT © 2019 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 79
ISO 22000 2018 TRANSLATED INTO PLAIN ENGLISH
8. OPERATIONS
83 Consider how easy equipment is to maintain. DO DN NA
84 Consider how easy equipment is to clean. DO DN NA
85 Consider your utilities as you establish your PRPs. DO DN NA
86 Consider resource providers as you establish PRPs. DO DN NA
87 Consider your organization’s supplies of energy. DO DN NA
88 Consider your organization’s supplies of water. DO DN NA
89 Consider your organization’s supplies of air. DO DN NA
90 Consider waste disposal as you establish PRPs. DO DN NA
91 Consider sewage disposal as you establish PRPs. DO DN NA
92 Consider your suppliers' constraints as you establish PRPs. DO DN NA
93 Consider your suppliers' processes as you establish PRPs. DO DN NA
94 Consider their quality assurance processes. DO DN NA
95 Consider how raw materials are approved. DO DN NA
96 Consider how ingredients are approved. DO DN NA
97 Consider how chemicals are approved. DO DN NA
98 Consider how packaging is approved. DO DN NA
99 Ensure that PRP records and documents are established. DO DN NA
100 Document how your PRPs should be managed. DO DN NA
101 Document how PRPs should be selected. DO DN NA
102 Document how PRPs should be established. DO DN NA
103 Document how PRPs should be monitored. DO DN NA
104 Document how PRPs should be verified. DO DN NA
ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
JULY 2019 PLAIN ENGLISH FOOD SAFETY MANAGEMENT STANDARD EDITION 1.0
PART 8 COPYRIGHT © 2019 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 80
ISO 22000 2018 TRANSLATED INTO PLAIN ENGLISH
8. OPERATIONS
8.3 ESTABLISH AN EFFECTIVE PRODUCT TRACEABILITY SYSTEM
105 Develop an effective material and product traceability system. DO DN NA Traceability is the ability
to identify and trace the
history, movement, location,
106 Develop a system that meets all relevant requirements. DO DN NA and application of objects.
A traceability system records
and follows the trail as
107 Develop a system that meets customer requirements. DO DN NA objects come from their
source and on through to
production, processing,
108 Develop a system that meets regulatory requirements. DO DN NA and final distribution.
109 Develop a system that meets statutory requirements. DO DN NA
110 Implement an effective material and product traceability system. DO DN NA
111 Implement a system that can keep track of end products. DO DN NA
112 Implement a system that can trace the distribution of end products. DO DN NA
113 Implement a system that tracks first stage distribution routes of end products. DO DN NA
114 Implement a system that can trace end products back to the source. DO DN NA
115 Implement a system that can trace end products back to lots of ingredients. DO DN NA
116 Implement a system that can trace end products back to lots of raw materials. DO DN NA
117 Implement a system that can trace end products back to intermediate products. DO DN NA
118 Implement a system that can keep track of reworked elements. DO DN NA
119 Implement a system that can keep track of reworked products. DO DN NA
120 Implement a system that can keep track of reworked end products. DO DN NA
121 Implement a system that can keep track of reworked intermediate products. DO DN NA
122 Implement a system that can keep track of reworked raw materials. DO DN NA
123 Evaluate your material and product traceability system. DO DN NA
124 Verify and test the effectiveness of your traceability system. DO DN NA
ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
JULY 2019 PLAIN ENGLISH FOOD SAFETY MANAGEMENT STANDARD EDITION 1.0
PART 8 COPYRIGHT © 2019 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 81
ISO 22000 2018 TRANSLATED INTO PLAIN ENGLISH
8. OPERATIONS
125 Reconcile quantities of ingredients with quantities of end products. DO DN NA
126 Maintain your organization’s material and product traceability system. DO DN NA
127 Retain traceability records for a period no less than the shelf life of products. DO DN NA
8.4 ESTABLISH EMERGENCY MANAGEMENT ARRANGEMENTS
8.4.1 FORMULATE EMERGENCY RESPONSE PROCEDURES
128 Establish procedures to respond to potential emergency situations and incidents. DO DN NA
129 Address situations and incidents that could have an impact on food safety. DO DN NA
130 Address the role that your organization plays in the food chain. DO DN NA
131 Document your emergency response procedures and maintain a record of results. DO DN NA
132 Use your documents and records to support emergency response activities. DO DN NA
8.4.2 RESPOND TO EMERGENCY SITUATIONS AND INCIDENTS
133 Consider relevant emergency response requirements. DO DN NA
134 Consider statutory emergency response requirements. DO DN NA
135 Consider regulatory emergency response requirements. DO DN NA
136 Consider customers' emergency response requirements. DO DN NA
137 Prepare for food safety incidents and emergencies. DO DN NA
138 Consider preparing for natural disasters. DO DN NA
139 Consider preparing for bioterrorist attacks. DO DN NA
140 Consider preparing for workplace accidents. DO DN NA
141 Consider preparing for environmental incidents. DO DN NA
142 Consider preparing for public health emergencies. DO DN NA
ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
JULY 2019 PLAIN ENGLISH FOOD SAFETY MANAGEMENT STANDARD EDITION 1.0
PART 8 COPYRIGHT © 2019 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 82
ISO 22000 2018 TRANSLATED INTO PLAIN ENGLISH
8. OPERATIONS
143 Consider preparing for support service interruptions. DO DN NA
144 Consider preparing for water supply problems. DO DN NA
145 Consider preparing for electricity supply problems. DO DN NA
146 Consider preparing for refrigeration supply problems. DO DN NA
147 Respond to actual food safety incidents and emergencies. DO DN NA
148 Respond to emergencies by communicating internally. DO DN NA
149 Respond to emergencies by communicating externally. DO DN NA
150 Communicate with all relevant authorities. DO DN NA
151 Communicate with all relevant customers. DO DN NA
152 Communicate with all relevant suppliers. DO DN NA
153 Communicate with all relevant media. DO DN NA
154 Mitigate the impact of all incidents and emergencies. DO DN NA
155 Consider the magnitude of each emergency or incident. DO DN NA
156 Consider the potential impact on food safety. DO DN NA
157 Periodically test your emergency response procedures. DO DN NA
158 Review your emergency response documents and records. DO DN NA
159 Review emergency response documents after each emergency. DO DN NA
160 Update your documents after each emergency (if necessary). DO DN NA
161 Review emergency response documents after each incident. DO DN NA
162 Update your documents after each incident (if necessary). DO DN NA
163 Review emergency response documents after each test. DO DN NA
164 Update your documents after each test (if necessary). DO DN NA
ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
JULY 2019 PLAIN ENGLISH FOOD SAFETY MANAGEMENT STANDARD EDITION 1.0
PART 8 COPYRIGHT © 2019 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. PAGE 83
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