Thursday, August 13 2020

ISO 22000 REQUIREMENTS version 2018

Requirements ISO 22000 version 2018

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The "ISO 22000 version 2018 Requirements" quiz will help you understand the main requirements of the standard.

The questions (requirements) included in this quiz are 132 of the 451 in the standard, but don't worry. These requirements are among the most important. So do not hesitate to learn in a fun way!

Do not think you can finish this quiz in less than an hour, or even two hours, unless of course you are a little genius!

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The T 70v18 training package ISO 22000 version 2018 readiness and internal audit

The 451 ISO 22000 version 2018 requirements (verb shall) of clauses 4 to 10 are as follows: 

ISO 22000: 2018 requirements 
No
Clause
PDCA cycle
Requirement No
Quantity
4
Context Plan 1 ÷ 12 12
5
Leadership Plan, Do, Check, Act
13 ÷ 39
27
6
Planning Plan
40 ÷ 67
28
7
Support Do
67 ÷ 138
72
8
Operation Do
139 ÷ 374
236
9
Performance Check
375 ÷ 420
46
10
Improvement Act
419 ÷ 448
30
Total
451

 

ISO 22000 requirements

ISO 22000 version 2018 requirements

 

pdca

The Deming PDCA cycle

Note. Any requirement normally begins with "The organization shall...". For simplicity's sake we present the requirements directly, starting with the verb

ISO 22000 - Requirements and comments
No
Clause, sub-clause
Requirement
Comment, link
  4
Context of the organization
 
4.1
The organization and its context
 
1
4.1
Determine external and internal issues Understand everything that can influence the purpose and strategic direction of the company (corporate culture, innovation, strategic direction, competition, market, obligations). Cf. sub-clause 6.1
2
4.1
Identify, review and update information about external and internal issues Issue: what can be gained or lost during an activity (factors, conditions). Some issues may change quickly, so stay alert. See § 9.3
 
4.2
Interested parties
 
3
4.2 a Detrmine the interested parties

"There is only one valid definition of a business purpose: to create a customer. Peter Drucker". List of relevant interested parties

4
4.2 b
Clarify the requirements of interested parties Every need and expectation is unique. Aim for a partnership in the long term. Including legal requirements
5
4.2
Identify, review and update information about interested parties Before accepting an order. Cf. sub-clause 7.5
 
4.3
Scope of the FSMS
 
6
4.3
Determine the scope of the FSMS Geographical and organizational scope available to interested parties
7
4.3
Take into account the products and services Including specific processes and production sites
8
4.3
Take into account everything that can have an influence on the food safety of end products Such as activities, products and services
9
4.3 a
Take into account the external and internal issues Cf. sub-clause 4.1
10
4.3 b
Take into account the requirements of interested parties Cf. sub-clause 4.2
11 4.3 Maintain the scope of the FSMS available as documented information Cf. sub-clause 7.5
 
4.4
FSMS
up
12
4.4
Establish, implement, maintain, update and continually improve a process-based FSMS For this it is necessary to determine the necessary processes, their applications, sequence and interactions. Process sheet, flow diagram
 
5
Leadership
Plan Do, CheckAct 
 
5.1 
Commitment
 
13
5.1 a
Ensure that the food safety policy and objectives are established and are compatible with the strategic direction of the organization "When you sweep the stairs, you start at the top". Romanian proverb. Top management demonstrates leadership (fully assuming its responsibility and commitment)
14 5.1 b Integrate the FSMS requirements into the internal business processes Cf. sub-clause 4.4
15
5.1 c
Provide the resources neede for the FSMS Cf. sub-clause 7.1
16
5.1 d
Communicate the importance of an effective and conforming FSMS Cf. sub-clause 7.4
17
5.1 e
Evaluate and maintain the FSMS In order to achieve its intended results , cf. sub-clause 4.1
18
5.1 f
Support persons contributing to the FSMS In order to improve the effectiveness of the FSMS. "Employee first, customers second. Vineet Nayar".
19
5.1 g
Promote continual improvement Essential commitment of top management
20
5.1 h
Support management leadership

The responsibility and authority of managers are supported at all times by top management

 
5.2
FS policy
 
 
5.2.1
Establishing the FS policy
 
21  5.2.1 a Establish, implement and maintain an appropriate food safety policy Top management applies a policy tailored to the purpose, strategic direction, culture and context of the organization
22 5.2.1 b Provide a framework In order to define and review the food safety objectives
23 5.2.1 c Include a commitment to satisfy FS requirements Requirements relating to he food safety, statutory, regulatory and customer 
24 5.2.1 d Include communication  Internally and externally, cf. sub-clause 7.4
25 5.2.1 e Include a commitment to continual improvement Of the FSMS
26 5.2.1 f Include the competence guarantee In food safety
5.2.2
Communicating the FS policy
 up
27 5.2.2  a Maintain the FS policy as documented information And available internally, cf. sub-clause 7.5
28 5.2.2 b Communicate the FS policy In order to be understood ans implemented, cf. sub-clause 7.4
29 5.2.2 c Keep the FS policy available to interested parties The FS policy cannot be a confidential document, it is available to relevant interested parties
 
5.3
Roles, responsibilities, authorities
 
30
5.3.1
Define and communicate responsibilities and authorities Top management assigns all relevant roles of the FSMS
31
5.3.1 a
Assign the responsibilities and authorities In order to ensure that the FSMS conforms to the requirements of ISO 22000
32
5.3.1 b
Assign the responsibilities and authorities In order to report on the performance of the FSMS to top management
33
5.3.1 c
Assign the responsibilities and authorities In order to appoint the food safety team leader and its members
34
5.3.1 d
Assign the responsibilities and authorities In order to designate persons who can initiate and document actions  
35
5.3.2 a
Ensure that the FSMS is established, implemented, maintained and updated Role of the FS team leader
36
5.3.2 b
Manage and organize the FS team Role of the FS team leader
37
5.3.2 c
Ensure the training and competencies of the FS team Role of the FS team leader, cf. sub-clause 7.2
38
5.3.2 d
Report to top management on the suitability of the FSMS Role of the FS team leader
39
5.3.3
Have the responsibility to report to identified persons For any FSMS problem, by all staff
 
6
Planning
 
6.1
Actions to address risks
up
40  6.1.1 a Determine risks and opportunities In order to ensure that the FSMS can achieve its intended results, cf. sub-clauses 4.1 (context) and 4.2 (interested parties) and 4.3 (scope). "Any decision involves a risk". Peter Barge
41 6.1.1 b Determine risks and opportunities In order to increase desirable affects (beneficial impact - opportunity)
42
6.1.1 c
Determine risks and opportunities In order to reduce undesired effects (negative effect - threat). Risks related to public health are the responsibility of public authorities
43
6.1.1 d
Determine risks and opportunities In order to confirm the continual improvement approach, cf. sub-clause 10.2
44
6.1.2 a
Plan actions to address risks and opportunities Take into account risks in each process
45
6.1.2.b 1
Plan how to implement the actions Define how to integrate actions into the FSMS, cf. sub-clause 4.4
46
6.1.2 b 2
Plan how to evalaute the effectiveness of actions Monitor the effectiveness of each action, cf. sub-clauses 9.1 and 9.2
47
6.1.3 a
Adapt actions to address risks and opportunities In relation to the potential impact on food safety product conformity 
48
6.1.3 b
Adapt actions to address risks and opportunities In relation to the conformity of food products and services with customers
49
6.1.3 c
Adapt actions to address risks and opportunities In relation to requirements of interested parties
  6.2
FS objectives
 
50
6.2.1
Establish objectives for the FSMS "He who has no goals will not achieve them. Sun Tzu", cf. sub-clause 7.5
51
6.2.1 a
Choose objectives for the FSMS Clarify the criteria for setting objectives consistent with the FS policy
52
6.2.1 b
Use measurable objectives And realistic
53
6.2.1 c
Take into account applicable FS requirements Including statutory, regulatory and customer
54
6.2.1 d
Monitor objectives And verify them regularly
55
6.2.1 e
Communicate on objectives At all levels
56
6.2.1 f
Update objectives During management review, cf. sub-clause 9.3
57 6.2.1 Retain documented information on the objectives of the FSMS Cf. sub-clause 7.5
58 6.2.2 a Plan what will be done In order to achieve FS objectives
59
6.2.2 b
Plan the resources needed In order to achieve FS objectives
60
6.2.2 c
Plan the responsibilities In order to achieve FS objectives
61
6.2.2 d
Plan the deadlines to respect In order to achieve FS objectives
62
6.2.2 e
Plan how the results will  be evaluated In order to achieve FS objectives 
  6.3
Changes
 up
63
6.3
Plan the need for changes to the FSMS, implementation and communication "The only person who likes change is a wet baby"
64
6.3 a
Plan the changes Taking into account the purpose of the change and potential consequences, cf. sub-clause 6.1
65
6.3 b
Plan the changes Taking into account the continued integrity of the FSMS
66
6.3 c Plan the changes Taking into account the resources available, cf. sub-clause 7.1
67
6.3 d Plan the changes Taking into account the responsibilities and authorities allocated, cf. sub-clause 5.3
 
 7
Support
 
 7.1
Resources
 
 
 7.1.1
General
 
68
 7.1.1 Provide the resources needed In order to support the FSMS, cf. sub-clauses 7.1 and 10.3
69
 7.1.1 a Take into account the existing resources And their capabilities and constraints, cf. sub-clause 7.1.2
70
 7.1.1 b Take into account the need for external providers In order to obtain the necessary services not available internally
 7.1.2
People
 
71
 7.1.2 Provide competent persons necessary to operate and maintain an effective FSMS "But in the long run - and I emphasis this - no matter how good or successful you are or how clever or crafty, your business and its future are in the hands of the people you hire." Akio Morita "
72
 7.1.2 Retain the contract with external experts as documente information Including their competence, responsibilities and authorities, cf. sub-clause 7.5
 
 7.1.3
Infrastructure
 
73
 7.1.3 Provide and maintain the infrastructure needed to run processes In order to obtain compliant products and services. Examples: buildings, equipment, transportation, computer hardware, software
 
 7.1.4
Work environment
 
74
 7.1.4 Provide and maintain the work environment needed to run processes In order to obtain compliant products and services. Examples: corporate culture, work environment, temperature, ergonomics
 7.1.5
External elements of the FSMS
 up
75
7.1.5 a Ensure that externally provided elements of the FSMS are developed in accordance with the requirements of ISO 22000 Like PRPs, the hazard analysis and the hazard control plan, cf. sub-clauses 8.2, 8.5.2 and 8.5.4
76
 7.1.5 b Ensure that externally provided elements of the FSMS are adapted to the organization Including sites, processes and products
77
7.1.5 c Ensure that externally provided elements of the FSMS are adapted to the organization Including the food safety team
78
7.1.5 d Ensure that externally provided elements of the FSMS are implemented, maintained and updated in accordance with the requirements of ISO 22000 Cf. sub-clauses 8.1 to 8.9
79
7.1.5 e Ensure that externally provided elements of the FSMS are retained as documented information Cf. sub-clause 7.5
 7.1.6
External providers
 
80
7.1.6 a Establish and apply criteria for the evaluation and selection of external providers and monitor their performance In order to control processes, products and services provided. "You can outsource the activity but you can’t outsource the risk. Michael Gallagher "
81
7.1.6 b Communicate requirements to external providers Cf. sub-clause 7.4
82
7.1.6 c Ensure that what is provided by external providers does not adversely affect the organization to meet the requirements of the FSMS Processes, products and services provided are under control
83
7.1.6 d Retain documented information on evaluation of external providers Cf. sub-clause 7.5
   7.2
Competence
up
84 7.2 a Determine the necessary competence Identify all the people who influence the performance of the FSMS
85 7.2 b Ensure the persons responsible for the operation of the hazard control plan are competent On the basis of appropriate training and experience
87 7.2 c Ensure that the food safety team has multi-disciplinary competence In relation to the development and application of the FSMS as processes, products, equipment and hazards
86 7.2 d Acquire the necessary competence And evaluate the effectiveness of actions undertaken
88 7.2  e Retain documented information on competence Cf. sub-clause 7.5
   7.3 Awareness
 
89 7.3 a Make all relevant persons aware of the FS policy Including people working under the organization's control. Cf. sub-clause 5.2
90 7.3 b Make all relevant persons aware of the FS objectives Cf. sub-clause 6.2
91 7.3 c Make all relevant persons aware of their contribution And on the beneficial effects of improving the performance of the FSMS
92 7.3 d Make all relevant persons aware to the negative impacts If not conforming with FSMS requirements, cf. sub-clauses 8.9 and 10.1
   7.4
Communication
 
   7.4.1
General
 up
93 7.4.1 a Determine the necessary internal and external communication relevant to the FSMS On which subjects to communicate. "Good news walks, bad news runs". Swedish proverb
94  7.4.1 b Determine the necessary internal and external communication relevant to the FSMS When to communicate
95  7.4.1 c  Determine the necessary internal and external communication relevant to the FSMS With whom to communicate
96  7.4.1 d Determine the necessary internal and external communication relevant to the FSMS How to communicate
97  7.4.1 e Determine the necessary internal and external communication relevant to the FSMS Who will communicate
98  7.4.1 Ensure that the requirement for effective communication is understood By all persons whose activities have an impact on food safety
   7.4.2
External communication
 
99 7.4.2 Communicate externally sufficient information Available for interested parties
100 7.4.2 a Communicate effectively with external providers Cf. sub-clause 7.1.6
101 7.4.2 b 1 Communicate effectively with customers and consumers Product information related to food safety
102 7.4.2 b 2 Communicate effectively with customers and consumers On food hazards requiring control by other companies in the food chain
103 7.4.2 b 3 Communicate effectively with customers and consumers On contractual arrangements, rinquiries, orders and amendments
104 7.4.2 b 4 Communicate effectively with customers and consumers On customer feedback and complaints
105
7.4.2 c
Communicate effectively with statutory authorities And regulatory
106
7.4.2 d
Communicate effectively with other organizations Regarding the FSMS
107
7.4.2
Designate people with responsibility and authority for external communication For any information concerning food safety
108
7.4.2
Include information obtained as input for management review and update of the FSMS Cf. sub-clauses 9.3, 4.4 and 10.3
109
7.4.2
Retain documented information as evidence of external communication Cf. sub-clause 7.5
   7.4.3
Internal communication
 up
110
7.4.3
Communicate on food safety Internally
111
7.4.3 a
Ensure that the food safety team is informed of changes Regarding products
112
7.4.3 b
Ensure that the food safety team is informed of changes Regarding raw materials, ingredients and services
113
7.4.3 c
Ensure that the food safety team is informed of changes Regarding equipment and systems
114
7.4.3 d
Ensure that the food safety team is informed of changes Regarding premises, location of equipment and environment
115
7.4.3 e
Ensure that the food safety team is informed of changes  regarding cleaning and sanitation
116
7.4.3 f
Ensure that the food safety team is informed of changes  Regarding packaging, storage and distribution
117
7.4.3 g
Ensure that the food safety team is informed of changes Regarding competence, responsibilities and authorities
118
7.4.3 h
Ensure that the food safety team is informed of changes Regarding statutory and regulatory requirements
119
7.4.3 i
Ensure that the food safety team is informed of changes Regarding food safety hazards and control measures
120
7.4.3 j
Ensure that the food safety team is informed of changes Regarding customer requirements
121
7.4.3 k
Ensure that the food safety team is informed of changes Regarding information requests from interested parties
122
7.4.3 l
Ensure that the food safety team is informed of changes Regarding complaints and alerts on food safety hazards with the end product
123
7.4.3 m
Ensure that the food safety team is informed of changes Regarding other conditions that have an impact on food safety
124
7.4.3
Include this information when updating the FSMS  Cf. sub-clauses 4.4 and 10.3
125
7.4.3
Include this information to the management review As input, cf. sub-clause 9.3
   7.5
Documented information
 
   7.5.1
General
up
126  7.5.1 a Include documented information required by the ISO 22000 standard Documented information to maintain (documented procedures):

 

  • scope (sub-clause 4.3)
  • FS policy (sub-clause 5.2.2)
  • emergency situations (sub-clause 8.4.1)
  • hazard analysis (sub-clause 8.5.1.1)
  • raw materials, ingredients and materials (sub-clause 8.5.1.2)
  • end products (sub-clause 8.5.1.3)
  • intended use (sub-clause 8.5.1.4)
  • flow diagrams (sub-clause.8.5.1.5.1)
  • description of processes (sub-clause 8.5.1.5.3)
  • acceptable levels of hazard (sub-clause 8.5.2.2.3)
  • hazard assessment (sub-clause 8.5.2.3)
  • decision-making (sub-clause 8.5.2.4.2)
  • external requirements (sub-clause 8.5.2.4.2)
  • control measures (sub-clause 8.5.3)
  • hazard control plan (sub-clauses 8.5.4.1 and 8.5.4.5)
  • critical limits and action criteria (sub-clause 8.5.4.2)
  • assessment of monitoring and measurement (sub-clause 8.7)
  • monitoring and measurement software (sub-clause 8.7)
  • corrections (sub-clause 8.9.2.3)
  • corrective actions (sub-clause 8.9.3)
  • withdrawal, recall (sub-clause 8.9.5)
Documented information to retain (records)
  • external and internal issues (sub-clause 4.1)
  • interested parties (sub-clause 4.2)
  • objectives of the FSMS (sub-clause 6.2.1)
  • external expert assistance (sub-clause 7.1.2)
  • externally developed elements of the FSMS (sub-clause 7.1.5)
  • external providers (sub-clause 7.1.6)
  • staff competences (sub-clause 7.2)
  • communication (sub-clause 7.4.2)
  • of external origin (sub-clause 7.5.3)
  • operational planning and control (sub-clause 8.1)
  • PRPs (sub-clause 8.2)
  • traceability (sub-clause 8.3)
  • emergency situations (sub-clause 8.4.2)
  • flow diagrams (sub-clause 8.5.1.5.1)
  • hazard identification (sub-clause 8.5.2.2)
  • monitoring system (sub-clause 8.5.4.3)
  • calibration and verification of equipment (sub-clause 8.7)
  • verification (sub-clause 8.8.1)
  • correction (sub-clauses 8.9.2 and 8.9.2.4)
  • evaluation (sub-clause 8.9.2.3)
  • corrective actions (sub-clause 8.9.3)
  • potentially unsafe products (sub-clause 8.9.4.1)
  • evaluation for release (sub-clause 8.9.4.2)
  • disposition of nonconforming products (sub-clause 8.9.4.3)
  • withdrawal, recall (sub-clause 8.9.5)
  • monitoring and measurement (sub-clause 9.1)
  • analysis and evaluation of the performance of the FSMS (sub-clause 9.1.2)
  • audit program and audit results (sub-clause 9.2)
  • management review output(sub-clause 9.3.3)
  • nonconformities (sub-clause 10.1.2)
  • updates to the FSMS (sub-clause 10.3)
127  7.5.1 b Include documented information deemed necessary to the effectiveness of the FSMS "Spoken words fly away, written ones stay. Latin proverb"
128  7.5.1 c Include documented information and food safety requirements Required by statutory, regulatory authorities and customers
   7.5.2
Creating and updating
up
129 7.5.2 a Identify and describe documented information appropriately Such as title, author, date, coding
130 7.5.2 b Ensure that the format and the media of documented information are appropriate Language, software and graphics version. Examples of media: paper, electronic
131 7.5.2 c Review and approve documented information appropriately Who writes, who codify, who approves
   7.5.3
Control of documented information 
 
132 7.5.3.1 a  Control the availability of documented information Where and when it is needed in a form suitable for use
133 7.5.3.1 b Control the adequate protection of documented information Such as loss of confidentiality, improper use or loss of integrity
134 7.5.3.2 a Control the distribution, access and use of documented information Who is responsible, methods to use, rules to respect
135 7.5.3.2 b Control the distribution, access, retrieval and use of documented information Including preservation, protection and readability
136 7.5.3.2 c Control the changes of documented information Using updated versions, restricted access of outdated versions
137 7.5.3.2 d Control the retention and disposition of documented information Retention and disposition
138 7.5.3.2 Identify and control documented information of external origin Unique codification, access, protection
139 7.5.3.2 Protect documented information retained as evidence of conformity Who has the right to read, who has the right to modify or eliminate
   8
Realization of safe products
Do
   8.1
Operational planning and control
 
140  8.1 a Plan and determine the requirements for the realization of safe products By establishing process criteria in order to control processes, cf. sub-clauses 4.4 and 6.1
141  8.1 b Control processes In accordance with criteria
142  8.1 c Keep documented information on process control  In order to ensure that the processes have been carried out as planned. Cf. sub-clause 7.5.1
143  8.1 Control planned and unintended changes By analyzing the consequences of unintended changes, action to mitigate any adverse effects
144  8.1 Control outsourced processes Cf. sub-claise 7.1.6
 8.2 
Prerequisite programs (PRPs)
up
145 8.2.1 Control PRPs in the products, product processing and work environment In order to facilitate the prevention of contamiets
146 8.2.2 a Adapt PRPs to the organization And the context of the organization, cf. sub-clause 4.1
147 8.2.2 b Adapt PRPs to the type of operation And the nature of the products
148 8.2.2 c Apply the production system at all levels Programs applicable in general or to a particula product or process
149 8.2.2 d Approve PRPs By the food safety team
150 8.2.3 Identify statutory, regulatory and customer requirements When selecting or establishing PRPs
151 8.2.3 a Consider ISO/TS 22002 series Only applicable part
152 8.2.3 b Consider standards, codes of practice and guidelines Such as NF V01-001 and NF V01-006, European regulations 178/2002, 852/2002, 183/2005
153 8.2.4 a Consider, when establishing PRPs Buildings and utilities
154 8.2.4 b Consider, when establishing PRPs Premises, workplaces and facilities
155 8.2.4 c Consider, when establishing PRPs Supplies of air, water, energy and utilities
156 8.2.4 d Consider, when establishing PRPs Pest control, waste and sewage disposal
157
8.2.4 e
Consider, when establishing PRPs Equipment and its accesibility for cleaning and maintenance
158
8.2.4 f
Consider, when establishing PRPs Monitoring of external providers
159  8.2.4 g Consider, when establishing PRPs Reception of incoming materials, storage, handling, expedition and transport
160 8.2.4 h Consider, when establishing PRPs Prevention measures of cross contamination
161 8.2.4 i Consider, when establishing PRPs Cleaning and disinfecting
162 8.2.4 j Consider, when establishing PRPs Personal hygiene
163 8.2.4 k Consider, when establishing PRPs Product information
164 8.2.4 l Consider, when establishing PRPs Other elements needed
165 8.2.4 Control documented information on PRPs Including selection, establishment, monitoring and verification, cf. sub-clause 7.5
  8.3
Traceability
 
166 8.3 Be able to identify external providers Including suppliers and distributors
167 8.3 a Consider Relation of materials, ingredients, intermediate products to the end products 
168 8.3 b Consider Reworking and recycling
169 8.3 c Consider Distribution of the end product
170 8.3 Identify statutory, regulatory and customer requirements In relation with traceability
171 8.3 Retain documented information as evidence of the traceability For a defined period, as a minimum the shelf life of the product, cf. sub-clause 7.5
172 8.3 Verify and test the traceability system And its effectiveness
   8.4
Emergencies
 
 8.4.1
General
 
173  8.4.1 Prepare for and respond to emergencies Procedures are in place to respond to everything that can have an impact on food safety 
174  8.4.1 Maintain documented information on emergencies and incidents Cf. sub-clause 7.5 
 8.4.2
Handling of emergencies
up
175  8.4.2 a 1 Respond to emergency situations and incidents By identifying statutory and regulatory requirements
176 8.4.2 a 2 Respond to emergency situations and incidents By communicating internally appropriate information 
177 8.4.2 a 3 Respond to emergency situations and incidents By communicationg externally appropriate information to interested parties (customers, suppliers, authorities, media)
178 8.4.2 b Take appropriate actions to reduce the consequences Actions appropriate to the magnitude of the situation and the food safety impact such as natural disasters, interruption of services such as water, electricity
179 8.4.2 c Simulate test procedures to emergency situations Periodically, where practical
180 8.4.2 d Update the documented information On any emergency situation or inceident occurred and realzed simulations
   8.5
Hazard control
 
   8.5.1
Preliminary steps
 
 8.5.1.1
General
 
181  8.5.1.1 Collect, maintain and update preliminary documented information In order to analyze hazards. Done by the food safety team, cf. sub-clause 7.5
182 8.5.1.1 a Include statutory, regulatory and customer requirements Cf. sub-clause 4.2
183 8.5.1.1 b Include products, processes and equipment Provided by the organization
184 8.5.1.1 c Include food safety hazards Relevant to the FSMS
 8.5.1.2
Characteristics of materials
 
185 8.5.1.2 Identify statutory and regulatory food safety requirements For all raw materials, ingredients and product contact materials
186  8.5.1.2 a Maintain documented information on components in contact with the product Such as biological, chemical and physical characteristics, cf. sub-clauses 7.5 and 8.5.2
187  8.5.1.2 b Maintain documented information on components in contact with the product Such as ingredients, additives and processisng aids, cf. sub-clauses 7.5 and 8.5.2
188  8.5.1.2 c Maintain documented information on components in contact with the product Such as animal, mineral or vegetable source, cf. sub-clauses 7.5 and 8.5.2
189  8.5.1.2 d Maintain documented information on components in contact with the product Such as place of origin, cf. sub-clauses 7.5 and 8.5.2
190 8.5.1.2 e Maintain documented information on components in contact with the product Such as production method, cf. sub-clauses 7.5 and 8.5.2
191 8.5.1.2 f Maintain documented information on components in contact with the product Such as method of packaging and delivery, cf. sub-clauses 7.5 and 8.5.2
192 8.5.1.2 g Maintain documented information on components in contact with the product Such as storage conditions and shelf life, cf. sub-clauses 7.5 and 8.5.2
193 8.5.1.2 h Maintain documented information on components in contact with the product Such as preparation, handling or processing, cf. sub-clauses 7.5 and 8.5.2
194 8.5.1.2 i Maintain documented information on components in contact with the product Such as food safety accpetance criteria or purchase specifications, cf. sub-clauses 7.5 and 8.5.2
8.5.1.3
Characteristics of end products
up
195 8.5.1.3 Identify all statutory and regulatory food safety requirements For all the end products
196 8.5.1.3 a Maintain documented information concerning the characteristics of end products Such as product name, cf. sub-clauses 7.5 and 8.5.2
197 8.5.1.3 b Maintain documented information concerning the characteristics of end products Such as composition, cf. sub-clauses 7.5 and 8.5.2
198 8.5.1.3 c Maintain documented information concerning the characteristics of end products Such as biological, chemical and physical characteristics, cf. sub-clauses 7.5 and 8.5.2
199 8.5.1.3 d Maintain documented information concerning the characteristics of end products Such as shelf life and storage conditions, cf. sub-clauses 7.5 and 8.5.2
200 8.5.1.3 e Maintain documented information concerning the characteristics of end products Such as packaging, cf. sub-clauses 7.5 and 8.5.2
201 8.5.1.3 f Maintain documented information concerning the characteristics of end products Such as labelling, and handling, preparation and use instructions, cf. sub-clauses 7.5 and 8.5.2
202 8.5.1.3 g Maintain documented information concerning the characteristics of end products Such as distribution and delivery methods, cf. sub-clauses 7.5 and 8.5.2
8.5.1.4
Intended use
 
203 8.5.1.4 Consider the intended use and handling of the end product Including reasonably expected unintended use and misuse
204 8.5.1.4 Maintain the intended use as documented information For the hazard analysis, cf. sub-clauses 7.5 and 8.5.2
205 8.5.1.4 Identify groups of consumers or users  Where appropriate
206  8.5.1.4 Identify groups of consumers or users known to be especially vulnerable  To specific food safety hazards
  8.5.1.5
Flow diagrams and description of processes
 
8.5.1.5.1
Preparation of the flow diagrams
 
207 8.5.1.5.1 Establish, maintain and update flow diagrams for the processes, products and product categories To be done by the food safety team as documented information, cf. sub-clause 7.5
208 8.5.1.5.1 Use flow diagrams as a graphic representation of processes In order to evaluate food safety hazards during hazard analysis , cf. sub-clause 8.5.2
209 8.5.1.5.1 Create clear, accurate and detailed flow diagrams In order to carry out a hazard analysis , cf. sub-clause 8.5.2
210 8.5.1.5.1 a Include in the flow diagram Steps, sequences and interactions 
211 8.5.1.5.1 b Include in the flow diagram Any oursourced processes, cf. sub-clause 7.1.6
 
212 8.5.1.5.1 c Include in the flow diagram Components introduction points (raw materials, ingredients, processing aids, packaging, intermediate products)
213 8.5.1.5.1 d Include in the flow diagram Points of reworking and recycling
214  8.5.1.5.1 e Include in the flow diagram Points of release of end products, intermediate products, derivatives and waste
  8.5.1.5.2
On-site confirmation of flow diagrams
up
215 8.5.1.5.2 Confirm on-site the accuracy of the flow diagrams To be done by the food safety team
216 8.5.1.5.2 Update the flow diagrams To be done by the food safety team
217  8.5.1.5.2 Retain flow diagrams as documented information Cf. sub-clause 7.5
8.5.1.5.3
Description of processes and their environment
 
218 8.5.1.5.3 a Describe the layout of promises To be done by the food safety team in order to carry out an analysis of hazards, including in handling areas
219 8.5.1.5.3 b Describe processing equipment, contact materials, processing aids and flow of materials And material flow
220 8.5.1.5.3 c Describe existing PRPs, process parameters and control measures  And procedures that can influence food safety
221 8.5.1.5.3 d Describe external requirements that can impact the control measures Such as statutory, regulatory and customers
222 8.5.1.5.3 Include the variations Resulting from expected seasonal changes or shift patterns
223 8.5.1.5.3 Update and maintain the descriptions of processes as documented information Cf. sub-clause 7.5
8.5.2
Hazard control
 
  8.5.2.1
General
 
224  8.5.2.1 Conduct a hazard analysis based on the preliminary information To be done by the food safety tean in order to determine hazards to be controlled, cf. sub-clause 8.5.1.1
225  8.5.2.1 Ensure food safety With a sufficient degree of control. Or, where appropriate, use a combination of control measures
8.5.2.2
Hazard identification and acceptable levels
up
226  8.5.2.2.1 Identify and document all food safety hazard In relation to the process, product and the environment of the process. Examine the hazards in sufficient detail to evaluate them and select the appropriate control measures
227 8.5.2.2.1 a Base hazard identification on The preliminary information, cf. sub-clause 8.5.1.1
228 8.5.2.2.1 b Base hazard identification on The experience of the FS team, staff and external experts
229 8.5.2.2.1 c Base hazard identification on Internal and external information (epidemiological and scientific data)
230 8.5.2.2.1 d Base hazard identification on The information of the food chain (food safety-related hazards of end products, intermediate products and at the moment of consumption)
231 8.5.2.2.1 e Base hazard identification on Statutory, regulatory and cutomer requirements and the Codex Alimentarius Commision
232 8.5.2.2.2 Identify the possible steps at which each hazard can be introduced Such as reception, processing, handling, storage, distribution, delivery
233 8.5.2.2.2 a Consider when identifying hazards Stages preceding and following in the food chain
234 8.5.2.2.2 b Consider when identifying hazards  All steps in the flow diagram
235 8.5.2.2.2 c Consider when identifying hazards People, equipment, services and process environment
236 8.5.2.2.3 Determine the acceptable level of each food safety hazard identified In the end product
237 8.5.2.2.3 a Identify statutory, regulatory and customer requirements When determining acceptable levels
238 8.5.2.2.3 b Consider the intended use When determining acceptable levels
239 8.5.2.2.3 c Consider any other relevant information When determining acceptable levels
240 8.5.2.2.3 Maintain documented information on acceptable levels  And the justification for the acceptable levels, cf. sub-clause 7.5
8.5.2.3
Hazard assessment
 
241 8.5.2.3 Conduct a hazard assessment for each identified hazard In order to determine the need for prevention or reduction
242 8.5.2.3 a Evaluate each food safety hazard With regard to the likelihood  of its occurrence prior to the application of control measures
243 8.5.2.3 b Evaluate each food safety hazard With regard to the severity of its adverse health effects in relation to the intended use, cf. 8.5.1.4
244 8.5.2.3 Identify any significant hazards In relation to food safety
245 8.5.2.3 Describe the methodology used and maintain the results of the hazard assessment as documented information Cf. sub-clause 7.5
  8.5.2.4
Control measures
 up
246 8.5.2.4.1 Select a control measure or combination of control measures based on the hazard assessment In order to prevent or reduce significant food safety hazards to an acceptable level, cf. sub-clause 8.5.2.3
247 8.5.2.4.1 Categorize the control measures in oPRP or CCP Cf. sub-clause 8.5.4
248 8.5.2.4.1 Carry out the categorization of control measures Using a systematic approach
249 8.5.2.4.1 a Assess for each control measure selected The likelihood of failure of its functioning
250 8.5.2.4.1 b 1 Assess for each control measure selected The severity of the consequences of failure including the impact on significant food safety hazards
251 8.5.2.4.1 b 2 Assess for each control measure selected The severity of the consequences of failure including the location in relation to other control measures
252 8.5.2.4.1 b 3 Assess for each control measure selected The severity of the consequences of failure including whether the measure will reduce the hazards to an acceptable level
253 8.5.2.4.1 b 4 Assess for each control measure selected The severity of the consequences of failure including whether it is a single measure or is part of combination of control measures
254 8.5.2.4.2 a Include an assessment of the feasibility for each control measure Establishing measurable critical limits and measurable action criteria (observable)
255 8.5.2.4.2 b Include an assessment of the feasibility for each control measure Monitoring to detect any failure to remain within critical limits or measurable action criteria
256 8.5.2.4.2 c Include an assessment of the feasibility for each control measure Applying timely corrections
257 8.5.2.4.2 Maintain the decision-making process, results of the selection and categorization of the control measures as documented information Cf. sub-clause 7.5
258 8.5.2.4.2 Maintain external requirements as documented information Requirements such as statutory, regulatory and customer, that can impact the selection and strictness of the control measures, cf. sub-clause 7.5 
8.5.3
Validation of control measures and their combinations
up
259 8.5.3 Validate the selected control measures that are capable of achieving the intended control of significant food safety hazards By the food safety team
260 8.5.3 Conduct validation prior to implementation of control measure or combination of control measures Including validation in the hazard control plan, cf. sub-clause 8.5.4 and following any change of the plan, cf. sub-clauses 7.4.2, 7.4.3, 10.2 and 10.3
261 8.5.3 Re-assess the control measures when the result of validation shows that the control measures are not capable of achieving the intended control  By the food safety team
262 8.5.3 Maintain the validation methodology and evidence of capability of the control measures to achieve the intended control as documented information By the food safety team, cf. sub-clause 7.5
8.5.4
Hazard control plan (HACCP/oPRP plan
 
8.5.4.1
General
 
263 8.5.4.1 Establish, implement and maintain a hazard control plan By the food safety team
264 8.5.4.1 Maintain the hazard control plan as documented information Cf. sub-clause 7.5
265 8.5.4.1 a Include in the hazard control plan The food safety hazards have to be controlled at the CCP level or through oPRP
266 8.5.4.1 b Include in the hazard control plan Critical limits at CCP or action criteria for oPRP
267 8.5.4.1 c Include in the hazard control plan Monitoring procedures
268 8.5.4.1 d Include in the hazard control plan Corrections to undertake in case critical limits or action criteria are not met
269 8.5.4.1 e Include in the hazard control plan  Responsibilities and authorities
270 8.5.4.1 f Include in the hazard control plan  Records (documented information to retain) of monitoring, cf. sub-clause 7.5
8.5.4.2
Critical limits and action criteria
 
271 8.5.4.2 Specify critical limits and action criteria At CCPs and for oPRPs
272 8.5.4.2 Maintain the rationale for their determination as documented information Cf. sub-clause 7.5
273 8.5.4.2 Use measurable critical limits at CCPs By the food safety team
274 8.5.4.2 Ensure that the acceptable level is not exceeded Conformance with critical limits
275 8.5.4.2 Use measurable action criteria for oPRPs Or observable
276 8.5.4.2 Ensure that the acceptable level is not exceeded Conformance with action criteria
8.5.4.3
Monitoring systems
up
277 8.5.4.3 Establish at each CCP a monitoring system for each control measure or combination of control measures In order to detect any failure to remain within critical limits
278 8.5.4.3 Include in the monitoring system all scheduled measurements Relative to critical limits
279 8.5.4.3 Establish for each oPRP a monitoring system for each control measure or combination of control measures In order to detect any failure to remain within action criteria
280 8.5.4.3 a Include in the monitoring system documented information On results of measurements or observation within an adequate time frame, cf. sub-clause 7.5
281 8.5.4.3 b Include in the monitoring system documented information On monitoring methods or devices used, cf. sub-clause 7.5
282 8.5.4.3 c Include in the monitoring system documented information On calibration methods or equivalent methods, cf. sub-clause 7.5
283 8.5.4.3 d Include in the monitoring system documented information On monitoring frequency, cf. sub-clause 7.5
284 8.5.4.3 e Include in the monitoring system documented information On monitoring results, cf. sub-clause 7.5
285 8.5.4.3 f Include in the monitoring system documented information On monitoring responsibilities and authorities 
286 8.5.4.3 g Include in the monitoring system documented information On responsibilities and authorities related to evaluation of monitoring results
287 8.5.4.3 Allow each CCP to quickly detect any failure to remain within critical limits In order to isolate and evaluate the product, cf. sub-clause 8.9.4.1
288 8.5.4.3 Use monitoring method and frequency for each oPRP proportionate to the likelihood of failure And the severity of consequences
289 8.5.4.3 Support the monitoring method of an oPRP based on observation data as a visual inspection By instructions or specifications
  8.5.4.4
Actions when critical limits or action criteria are not met
 
290 8.5.4.4 Specify corrections and corrective actions to be taken when critical limits and action criteria are not met Cf. sub-clauses 8.9.2 and 8.9.3
291 8.5.4.4 a Ensure that potentially unsafe products are not released Cf. sub-clause 8.9.4.1
292 8.5.4.4 b Identify the cause of nonconformity Cf. sub-clause 8.9.3
293 8.5.4.4 c Ensure that again the critical limits and action criteria are met Cf. sub-clause 9.1
294 8.5.4.4 d Ensure that recurrence is preventedMake corrections and corrective actions Cf. sub-clause 8.9.3
295 8.5.4.4 Make corrections and corrective actions In accordance with sub-clauses 8.9.2 and 8.9.3
8.5.4.5
Implementation of the hazard control plan
up
296 8.5.4.5 Implement and maintain the hazard control plan Cf. sub-clause 8.5.4.1
297 8.5.4.5 Retain evidence of the implementation of the hazard control plan as documented information  Cf. sub-clause 7.5
  8.6
Update of PRPs and the hazard control plan
 
298  8.6 a Update, if necessary, the information specifying the PRPs and the hazard control plan Characteristics of product-contact materials, cf. sub-clause 8.5.1.2
299 8.6 b Update, if necessary, the information specifying the PRPs and the hazard control plan Characteristics of end product, cf. sub-clause 8.5.1.3
300 8.6 c Update, if necessary, the information specifying the PRPs and the hazard control plan Intended use, cf. sub-clause 8.5.1.4
301 8.6 d Update, if necessary, the information specifying the PRPs and the hazard control plan Flow diagrams, descriptions of processes and process environment, cf. sub-clause 8.5.1.5.1
302 8.6 Ensure that the hazard control plan and the PRPs are updated Cf. sub-clauses 8.5.4 and 8.2
  8.7
Control of monitoring and measuring
 
303 8.7 Provide evidence that the specified monitoring and measuring methods are adequate related to the PRPs and the hazard control plan Equipment in use 
304 8.7 a Use appropriate monitoring and measuring equipment Calibrated and verified regularly
305 8.7 b Use appropriate monitoring and measuring equipment Adjusted as many times as needed
306 8.7 c Use appropriate monitoring and measuring equipment Idnetified (with calibration date)
307 8.7 d Use appropriate monitoring and measuring equipment Protected against maladjustments
308 8.7 e Use appropriate monitoring and measuring equipment Protected against deterioration
309 8.7 Retain the results of calibration and verification as documented information Cf. sub-clause 7.5
310 8.7 Base calibration on standards  National or international
311 8.7 Retain the basis used for calibration or verification as documented information When no standard exists, cf. sub-clause 7.5 
312 8.7 Assess the validity of the previous results When the equipment or the process environment is not conforming
313 8.7 Take appropriate action On nonconforming equipment or process environment
314 8.7 Maintain the assessment and resultin action as documented information Cf. sub-clause 7.5
315 8.7 Validate software used in monitoring and measuring prior to use By the organization, the supplier or third party
316 8.7 Maintain validation activities as documented information Cf. sub-clause 7.5
317 8.7 Update the software in a timely manner With the software supplier
318 8.7 Authorize, document and validate software changes  Prior implementation
  8.8
Verification of PRPs and hazard control plan
 
  8.8.1
Verification
up
319 8.8.1 Establish, implement and maintain verification activities "Inspection does not improve quality, nor guarantee quality. Edwards Deming"
320 8.8.1 Define purpose, methods, frequencies and responsibilities for the verification activities This is part of verification planning
321 8.8.1 a Include in verification activities The implementation and effectiveness of PRPs
322 8.8.1 b Include in verification activities The implementation and effectiveness of the hazard control plan
323 8.8.1 c Include in verification activities The state of acceptable hazard levels
324 8.8.1 d Include in verification activities Updating input to the hazard analysis
325 8.8.1 e Include in verification activities The implementation and effectiveness of other actions
326 8.8.1 Ensure that verification activities are not carried out by the person responsible for monitoring these activities "No one is a judge in his own case. Latin proverb"
327 8.8.1 Retain verification results as documented information And communicate them, cf. sub-clauses 7.4 and 7.5
328 8.8.1 Handle products as potentially unsafe and apply corrective actions When the verification found nonconforming samples (non-acceptable level of the food safety hazard), cf. sub-clauses 8.5.2.2, 8.9.4.3 and 8.9.3
  8.8.2
Analysis of verification activities
 
329 8.8.2 Conduct an analysis of the results of verification and use as an input to the performance evaluation of the FSMS Cf. sub-clause 9.1.2
  8.9
Control of nonconformities
 
  8.9.1
General
 
330  8.9.1 Ensure that the results from the monitoring of oPRPs and at CCPs are evaluated by competent persons And who has the authority to initiate corrections and corrective actions, cf. sub-clauses 8.9.2 and 8.9.3
8.9.2
Corrections
up
331 8.9.2.1 Identify and control nonconforming products with corrections When critical limits at CCPs or action criteria for oPRPs are not met
332 8.9.2.1 a Include in established, maintained and updated documented information A method of identification, assessment and correction for affected products in order to ensure their prpoer handling, cf. sub-clause 7.5
333 8.9.2.1 b Include in established, maintained and updated documented information Arrangements for review of corrections
334 8.9.2.2 Identify products when critical limits at CCP are not met Considering them as unsafe products, cf. sub-clause 8.9.4.1
335 8.9.2.3 a Carry out actions where action criteria for an oPRP are not met By determining the food safety consequences 
336 8.9.2.3 b Carry out actions where action criteria for an oPRP are not met By determining the causes
337 8.9.2.3 c Carry out actions where action criteria for an oPRP are not met By identifying the products concerned and their handling, cf. sub-clause 8.9.4.1
338 8.9.2.3 Retain results of the evaluation as documented information Cf. sub-clause 7.5
339 8.9.2.4 a Retain results of corrections as documented information The nature of the nonconformity, cf. sub-clause 7.5
340 8.9.2.4 b Retain results of corrections as documented information  The causes of the nonconformity, cf. sub-clause 7.5
341 8.9.2.4 c Retain results of corrections as documented information The consequences of the nonconformity, cf. sub-clause 7.5
8.9.3
Corrective actions
 
342 8.9.3 Evaluate the need for corrective actions When critical limits at CCPs or action criteria for oPRPs are not met
343 8.9.3 Establish and maintain documented information on the control of nonconformities In order to prevent recurrence of nonconformities, cf. sub-clause 7.5
344 8.9.3 a Include in corrective actions Reviewing nonconformities following complaints or regulatory reports
345 8.9.3 b Include in corrective actions Reviewing trends in monitoring that can indicate loss of control
346 8.9.3 c Include in corrective actions Determining the root causes of nonconformities
347 8.9.3 d Include in corrective actions Determining and implementing actions in order to ensure that nonconformities will not recur
348 8.9.3 e Include in corrective actions Documenting the results, cf. sub-clause 7.5
349 8.9.3 f Include in corrective actions Verifying the effectiveness of actions
350 8.9.3 Retain documented information on corrective actions Cf. sub-clause 7.5
   8.9.4
Handling of potentially unsafe products
 
 8.9.4.1
General
up
351 8.9.4.1 a Undertake actions to prevent the entry of potentially unsafe products into the food chain unless Food safety hazards are reduced to acceptable levels
352 8.9.4.1 b Undertake actions to prevent the entry of potentially unsafe products into the food chain unless Food safety hazards will be reduced to acceptable levels prior to entering the food chain
353 8.9.4.1 c Undertake actions to prevent the entry of potentially unsafe products into the food chain unless The product still meets the defined acceptable level despite the nonconformity
354 8.9.4.1 Retain the control of products that have been identified as potentially unsafe Until the products are evaluated and their disposition determined, cf. sub-clause 8.9.4.3
355 8.9.4.1 Notify relevant interested parties if products are subsequently determined to be unsafe Initiate a withdrawal or recall, cf. sub-clause 8.9.5
356 8.9.4.1 Retain feedback from interested parties and authorization for dealing with potentially unsafe products as documented information Cf. sub-clause 7.5
 8.9.4.2
Evaluation for release
 
357 8.9.4.2 Evaluate each lot of products including nonconformities Concerning all unsafe products
358 8.9.4.2 Handle products with critical limits at CCPs not met Do not release but handled in accordance with sub-clause 8.9.4.3
359  8.9.4.2 a Release products as safe but affected by failure to meet action criteria for oPRPs provided that Monitoring demonstrates that the control measures are effective
360 8.9.4.2 b Release products as safe but affected by failure to meet action criteria for oPRPs provided that The combined effect of the control measures conforms to the performance intended (identified acceptable levels)
361 8.9.4.2 c Release products as safe but affected by failure to meet action criteria for oPRPs provided that The results of sampling, analysis or other verification activities demonstrate that the products conform to the identified acceptable levels 
362 8.9.4.2

Retain evaluation for release of products as documented information

Cf. sub-clause 7.5
 8.9.4.3
Disposition of nonconforming products
 
363 8.9.4.3 a Submit to a new transformation products that are not acceptable for release  In order to reduce food safety hazard to an acceptable level
364 8.9.4.3 b Redirect for other use products that are not acceptable for release  As long as food fasety in the food chain is not affected
365 8.9.4.3 c Destroy or dispose products that are not acceptable for release  As waste
366 8.9.4.3 Retain the disposition of nonconforming products as documented information Including the person with approving authority, cf. sub-clause 7.5
8.9.5
Withdrawal or recall
up
367 8.9.5 Ensure the timely withdrawal or recall of any lot identified as potentially unsafe By appointing a person having the authority to initiate and carry out the withdrawal or recall
368 8.9.5 a Maintain documented information for Notify interested parties (authorities, customers, cconsumers), cf. sub-clause 7.5
369 8.9.5 b Maintain documented information for Handling withdrawn, recalled or still in stock products, cf. sub-clause 7.5
370 8.9.5 c Maintain documented information for Performing actions to be taken, cf. sub-clause 7.5
371 8.9.5 Secure products withdrawn, recalled or still in stock Until they are managed in accordance with sub-clause 8.9.4.3
372 8.9.5 Retain the cause, extent and result of a withdrawal  and recall as documented information Cf. sub-clause 7.5
373 8.9.5 Report withdrawal and recall information as input to the management review Cf. sub-clause 9.3
374 8.9.5 Verify the implementation and effectiveness of withdrawals and recalls through the use of appropriate techniques  Such as simulations or pratical test
375 8.9.5 Retain the verification of the implementation and effectiveness of withdrawals and recalls as documented information Cf. sub-clause 7.5
   9
Performance evaluation
Check
   9.1
Monitoring, measurement, analysis and performance evaluation

   9.1.1
General
up
376 9.1.1 a Determine what needs to be inspected (monitored and measured)

"If you can't measure it, you can't manage it. Peter Drucker"

377 9.1.1 b Determine the methods for inspection, analysis and evaluation In order to ensure valid results
378 9.1.1 c Determine when to inspect At essential steps or following a customer request
379 9.1.1 d Determine when to analyze and evaluate the results of inspection When it brings added value
380 9.1.1 e Determine who shall analyze and evaluate the results of inspection  Responsibilities and authorities, cf. sub-clause 5.3
381 9.1.1 Retain inspection results as documented information Cf. sub-clause 7.5
382 9.1.1 Evaluate the performance and effectiveness of the FSMS In order to guarantee safe food at all times
   9.1.2
Analysis and evaluation
 
383 9.1.2 Analyze and evaluate the results of monitoring and measurement Including the results of verification activities related to PRPs and the hazard control plan and audits, cf. sub-clauses 8.8, 8.5.4 and 9.2
384 9.1.2 a Confirm that the overall performance of the organization meets the FSMS requirements By conducting an analysis of the management system
385 9.1.2 b Identify the need for updating or improving the FSMS By conducting an analysis of the management system, cf. sub-clauses 10.2 and 10.3
386 9.1.2 c Identify rate trends of potentially unsafe products or process failures By conducting an analysis of the management system
387 9.1.2 d Plan the audit program related to the status and importance of areas to be audited By conducting an analysis of the management system
388 9.1.2 e Provide evidence that corrections and corrective actions are effective By conducting an analysis of the management system
389 9.1.2 Retain the results of the analysis and the resulting activities as documented information Cf. sub-clause 7.5
390 9.1.2 Report the results as input to the management review and the updateing of the FSMS  Cf. sub-clauses 9.3 and 10.3
   9.2
Internal audit
up
391 9.2.1 a 1 Conduct regularly planned internal audits In order to determine whether the FSMS conforms to the internal requirements of the organization. Cf. ISO 19011
392 9.2.1 a 2 Conduct regularly planned internal audits In order to determine whether the FSMS conforms to the requirements of ISO 22000
393 9.2.1 b Conduct regularly planned internal audits In order to determine whether the FSMS is effective and updated
394 9.2.2 a Plan, establish, implement and update an internal audit program Including the frequency, methods, responsibilities, planning requirements (audit program) and the requirements for reporting (audit report)
395 9.2.2 a Take into account in the audit program the importance of the processes concerned

 Essential points such as:

  • process importance
  • changes in the FSMS
  • the results of:
    • monitoring
    • measurement
    • previous audits

"The quality control should verify the process, not the product. Edwards Deming"

396 9.2.2 b Define the audit criteria Define the scope of the audit; use defined and known audit criteria
397 9.2.2 c Select auditors Do not audit your own department. "No-one is a judge in his own case. Latin proverb"
398 9.2.2 d Ensure that the results of the audits are communicated to the food safe team and top management Cf. sub-clause 7.4
399 9.2.2 e Retain documented information on the application of the audit program and audit results Cf. sub-clause 7.5
400 9.2.2 f Undertake corrections quickly and corrective actions, if necessary Cf. sub-clauses 8.9.2 and 8.9.3
401 9.2.2 g Determine if the FSMS meets the food safety policy and objectives Cf. sub-clauses 5.2 and 6.2
   9.3
Management review
up
   9.3.1
General
 
402 9.3.1 Review the FSMS at least once a year In order to confirm its suitability, adequacy and effectiveness. "No system is perfect"
   9.3.2
Management review input
 
403 9.3.2 a Conduct management review Considering the status of actions from previous management reviews
404 9.3.2 b Conduct management review Considering changes in external and internal issues of the FSMS, including changes in the organization and its context
405 9.3.2 c 1 Take into account information on the performance and the effictiveness of the FSMS and trends On update of the FSMS, cf. sub-clauses 4.4 and 10.3
406 9.3.2 c 2 Take into account information on the performance and the effictiveness of the FSMS and trends Results of inspection, cf. sub-clause 9.1
407 9.3.2 c 3 Take into account information on the performance and the effictiveness of the FSMS and trends Results of verification of PRPs and the hazard control plan, cf. sub-clause 8.8.2
408 9.3.2 c 4 Take into account information on the performance and the effictiveness of the FSMS and trends Nonconformities and corrective actions, cf. sub-clauses 8.9.2 and 8.9.3
409 9.3.2 c 5 Take into account information on the performance and the effictiveness of the FSMS and trends  Audit results, cf. sub-clause 9.2
410 9.3.2 c 6 Take into account information on the performance and the effictiveness of the FSMS and trends Regulatory and customer inspections
411 9.3.2 c 7 Take into account information on the performance and the effictiveness of the FSMS and trends The performance of external providers, cf. sub-clause 7.1.6
412 9.3.2 c 8 Take into account information on the performance and the effictiveness of the FSMS and trends The review of risks, cf. sub-clause 6.1
413 9.3.2 c 9 Take into account information on the performance and the effictiveness of the FSMS and trends The extent to which objectives of the FSMS are met, cf. sub-clause 6.2
414 9.3.2 d Take into account the resources The adequacy of resources, cf. sub-clause 7.1
415 9.3.2 e Take into account any emergency situation, withdrawal or recall Including incidents, cf. sub-clauses 8.4.2 and 8.9.5
416 9.3.2 f Take into account feedback from external or internal origin Including complaints, cf. sub-clauses 7.4.2 and 7.4.3
417 9.3.2 g Take into account opportunities for improvement Continual improvement, cf. sub-clause 10.2
418 9.3.2 Present this data in a manner that enables top management to associate it with food safety objectives Cf. sub-clause 6.2
 9.3.3
Management review output
up
419 9.3.3 a Include in the output of the management review decisions and actions related to continual improvement opportunities Cf. sub-clause 10.2
420 9.3.3 b Include in the output of the management review decisions related to any need for changes to the FSMS Such as resources, fod safety policy and objectives, cf. sub-clauses 7.1, 5.2 and 6.2
421 9.3.3 Retain the results of the management review as documented information Cf. sub-clause 7.5
   10
Improvement
Act
   10.1
Nonconformities
 
422 10.1.1 a 1 React to the nonconformities By controlling it and correcting it. "Where there is a problem, there is potential for improvement. Masaaki Imai"
423 10.1.1 a 2 React to the nonconformities By dealing with the consequences
424 10.1.1 b 1 Evaluate the need for action to eliminate the root causes By reviewing the nonconformity
425 10.1.1 b 2 Evaluate the need for action to eliminate the root causes By researching and analyzing the root causes of nonconformity
426 10.1.1 b 3 Evaluate the need for action to eliminate the root causes By researching similar nonconformity of the past or the future
427 10.1.1 c Undertake any action needed In ordtreat the nonconformityer to 
428 10.1.1 d Review the effectiveness of corrective actions in order to verify whetehr the action is completed
429 10.1.1 e Make changes to the FSMS If necessary
430 10.1.1 React proportionally to the consequences of nonconformities Do not go overboard on quality
431 10.1.2 a Retain evidence of the nature of the nonconformities as documented information Cf. sub-clause 7.5
432 10.1.2 b Retain the results of action as documented information Cf. sub-clause 7.5
   10.2
Continual improvement
up
433 10.2 Improve continually the performance of the FSMS By finding improvement opportunities
434 10.2 Ensure continual improvement of the effectiveness of the FSMS through communication  Cf. sub-clause 7.4
435 10.2 Ensure continual improvement of the effectiveness of the FSMS through management review Cf. sub-clause 9.3
436 10.2 Ensure continual improvement of the effectiveness of the FSMS through internal audit Cf. sub-clause 9.2
437 10.2 Ensure continual improvement of the effectiveness of the FSMS through analysis of results of verification activities Cf. sub-clause 8.8.2
438 10.2 Ensure continual improvement of the effectiveness of the FSMS through validation of control measures Cf. sub-clause 8.5.3
439 10.2 Ensure continual improvement of the effectiveness of the FSMS through correctives actions Cf. sub-clause 8.9.3
440 10.2 Ensure continual improvement of the effectiveness of the FSMS through FSMS updating Cf. sub-clause 10.3
  10.3
Update of the FSMS
up
441 10.3 Ensure that the FSMS is updated Permanently
442 10.3 Evaluate the FSMS at planned intervals  By the food safety team
443 10.3 Evaluate the need to review the hazard analysis Cf. sub-clause 8.5.2
444 10.3 Evaluate the need to review the hazard control plan Cf. sub-clause 8.5.4
445 10.3 Evaluate the need to review the PRPs Cf. sub-clause 8.2
446 10.3 a Base updating activities on communication Cf. sub-clause 7.4
447 10.3 b Base updating activities on any othe information In relation with the suitability, adequacy and effectiveness
448 10.3 c Base updating activities on results of verification activities Cf. sub-clause 9.1.2
449 10.3 d Base updating activities on decisions from management review Cf. sub-clause 9.3
450 10.3 Retain system updating activities as documented information Cf. sub-clause 7.5
451 10.3 Report system updating activities as input to the management review Cf. sub-clause 9.3