ISO 22000 - Requirements and comments

Clause,
No sub- Requirement Comment, link
clause
Context of the
4 Plan
organization
The organization and
4.1
its context
1 4.1 Determine external and Understand everything that can influence
internal issues 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 Issue: what can be gained or lost during
update information an activity (factors, conditions). Some
about external and issues may change quickly, so stay alert.
internal issues See § 9.3
4.2 Interested parties
3 4.2 a Determine the "There is only one valid definition of a
interested parties business purpose: to create a
customer. Peter Drucker". List of
relevant interested parties
4 4.2 b Clarify the requirements Every need and expectation is unique. Aim
of interested parties for a partnership in the long term. Including
legal requirements
5 4.2 Identify, review and Before accepting an order. Cf. sub-clause
update information 7.5
about interested parties
4.3 Scope of the FSMS
6 4.3 Determine the scope of Geographical and organizational scope
the FSMS available to interested parties
7 4.3 Take into account the Including specific processes and
products and services production sites
8 4.3 Take into account Such as activities, products and services
everything that can have
an influence on the food
safety of end products
9 4.3 a Take into account the Cf. sub-clause 4.1
external and internal
issues
10 4.3 b Take into account the Cf. sub-clause 4.2
requirements of
interested parties
11 4.3 Maintain the scope of Cf. sub-clause 7.5
the FSMS available as
documented information
4.4 FSMS
12 4.4 Establish, implement, For this it is necessary to determine the
maintain, update and necessary processes, their applications,
continually improve a sequence and interactions. Process sheet,
process-based FSMS flow diagram
5 Leadership Plan , Do, Check, Act
5.1 Commitment
13 5.1 a Ensure that the food "When you sweep the stairs, you start
safety policy and at the top". Romanian proverb. Top
objectives are management demonstrates
established and are leadership (fully assuming its responsibility
compatible with the and commitment)
strategic direction of the
organization
14 5.1 b Integrate the FSMS Cf. sub-clause 4.4
requirements into the
internal business
processes
15 5.1 c Provide the resources Cf. sub-clause 7.1
neede for the FSMS
16 5.1 d Communicate the Cf. sub-clause 7.4
importance of an
effective and conforming
FSMS
17 5.1 e Evaluate and maintain In order to achieve its intended results , cf.
the FSMS sub-clause 4.1
18 5.1 f Support persons In order to improve the effectiveness of the
contributing to the FSMS. "Employee first, customers
FSMS second. Vineet Nayar".
19 5.1 g Promote continual Essential commitment of top management
improvement
20 5.1 h Support management The responsibility and authority of
leadership managers are supported at all times by top
management
5.2 FS policy
 Establishing the FS
5.2.1
policy
21 5.2.1 a Establish, implement Top management applies a policy tailored
and maintain an to the purpose, strategic direction, culture
appropriate food safety and context of the organization
policy
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 Requirements relating to he food safety,
satisfy FS requirements 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 Of the FSMS
continual improvement
26 5.2.1 f Include the competence In food safety
guarantee
Communicating the FS
5.2.2
policy
27 5.2.2 a Maintain the FS policy And available internally, cf. sub-clause 7.5
as documented
information
28 5.2.2 b Communicate the FS In order to be understood ans
policy implemented, cf. sub-clause 7.4
29 5.2.2 c Keep the FS policy The FS policy cannot be a confidential
available to interested document, it is available to relevant
parties interested parties
Roles, responsibilities,
5.3
authorities
30 5.3.1 Define and Top management assigns all relevant
communicate roles of the FSMS
responsibilities and
authorities
31 5.3.1 a Assign the In order to ensure that the FSMS conforms
responsibilities and to the requirements of ISO 22000
authorities
32 5.3.1 b Assign the In order to report on the performance of
responsibilities and the FSMS to top management
authorities
33 5.3.1 c Assign the In order to appoint the food safety team
responsibilities and leader and its members
authorities
34 5.3.1 d Assign the In order to designate persons who can
responsibilities and initiate and document actions
authorities
35 5.3.2 a Ensure that the FSMS is Role of the FS team leader
established,
implemented,
maintained and updated
36 5.3.2 b Manage and organize Role of the FS team leader
the FS team
37 5.3.2 c Ensure the training and Role of the FS team leader, cf. sub-clause
competencies of the FS 7.2
team
38 5.3.2 d Report to top Role of the FS team leader
management on the
suitability of the FSMS
39 5.3.3 Have the responsibility For any FSMS problem, by all staff
to report to identified
persons
6 Planning Plan
Actions to address
6.1
risks
40 6.1.1 a Determine risks and In order to ensure that the FSMS can
opportunities 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 In order to increase desirable affects
opportunities (beneficial impact - opportunity)
42 6.1.1 c Determine risks and In order to reduce undesired effects
opportunities (negative effect - threat). Risks related to
public health are the responsibility of
public authorities
43 6.1.1 d Determine risks and In order to confirm the continual
opportunities improvement approach, cf. sub-clause
10.2
44 6.1.2 a Plan actions to address Take into account risks in each process
risks and opportunities
45 6.1.2.b 1 Plan how to implement Define how to integrate actions into the
the actions FSMS, cf. sub-clause 4.4
46 6.1.2 b 2 Plan how to evalaute Monitor the effectiveness of each action,
the effectiveness of cf. sub-clauses 9.1 and 9.2
actions
47 6.1.3 a Adapt actions to In relation to the potential impact on food
address risks and safety product conformity
opportunities
48 6.1.3 b Adapt actions to In relation to the conformity of food
address risks and products and services with customers
opportunities
49 6.1.3 c Adapt actions to In relation to requirements of interested
address risks and parties
opportunities
6.2 FS objectives
50 6.2.1 Establish objectives for "He who has no goals will not achieve
the FSMS them. Sun Tzu", cf. sub-clause 7.5
51 6.2.1 a Choose objectives for Clarify the criteria for setting objectives
the FSMS consistent with the FS policy
52 6.2.1 b Use measurable And realistic
objectives
53 6.2.1 c Take into account Including statutory, regulatory and
applicable FS customer
requirements
54 6.2.1 d Monitor objectives And verify them regularly
55 6.2.1 e Communicate on At all levels
objectives
56 6.2.1 f Update objectives During management review, cf. sub-clause
9.3
57 6.2.1 Retain documented Cf. sub-clause 7.5
information on the
objectives of the FSMS
58 6.2.2 a Plan what will be done In order to achieve FS objectives
59 6.2.2 b Plan the resources In order to achieve FS objectives
needed
60 6.2.2 c Plan the responsibilities In order to achieve FS objectives
61 6.2.2 d Plan the deadlines to In order to achieve FS objectives
respect
62 6.2.2 e Plan how the results In order to achieve FS objectives
will be evaluated

6.3 Changes
63 6.3 Plan the need for "The only person who likes change is a
changes to the FSMS, wet baby"
implementation and
communication
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 Plan
7.1 Resources
7.1.1 General
68 7.1.1 Provide the resources In order to support the FSMS, cf. sub-
needed clauses 7.1 and 10.3
69 7.1.1 a Take into account the And their capabilities and constraints, cf.
existing resources sub-clause 7.1.2
70 7.1.1 b Take into account the In order to obtain the necessary services
need for external not available internally
providers
7.1.2 People
71 7.1.2 Provide competent "But in the long run - and I emphasis
persons necessary to this - no matter how good or successful
operate and maintain an you are or how clever or crafty, your
effective FSMS business and its future are in the hands
of the people you hire." Akio Morita "
72 7.1.2 Retain the contract with Including their competence,
external experts as responsibilities and authorities, cf. sub-
documente information clause 7.5
7.1.3 Infrastructure
73 7.1.3 Provide and maintain In order to obtain compliant products and
the infrastructure services. Examples: buildings, equipment,
needed to run transportation, computer hardware,
processes software
7.1.4 Work environment
74 7.1.4 Provide and maintain In order to obtain compliant products and
the work environment services. Examples: corporate culture,
 needed to run work environment, temperature,
processes ergonomics
External elements of
7.1.5
the FSMS
75 7.1.5 a Ensure that externally Like PRPs, the hazard analysis and the
provided elements of hazard control plan, cf. sub-clauses 8.2,
the FSMS are 8.5.2 and 8.5.4
developed in
accordance with the
requirements of ISO
22000
76 7.1.5 b Ensure that externally Including processes and products
provided elements of
the FSMS are
applicable to the sites of
the organization
77 7.1.5 c Ensure that externally By the food safety team
provided elements of
the FSMS are adapted
to the processes and
products of the
organization
78 7.1.5 d Ensure that externally Cf. sub-clauses 8.1 to 8.9
provided elements of
the FSMS are
implemented,
maintained and updated
in accordance with the
requirements of ISO
22000
79 7.1.5 e Ensure that externally Cf. sub-clause 7.5
provided elements of
the FSMS are retained
as documented
information
7.1.6 External providers
80 7.1.6 a Establish and apply In order to control processes, products and
criteria for the services provided. "You can outsource
evaluation and selection the activity but you can’t outsource the
of external providers risk. Michael Gallagher "
and monitor their
performance
81 7.1.6 b Communicate Cf. sub-clause 7.4
requirements to external
providers
82 7.1.6 c Ensure that what is Processes, products and services
provided by external provided are under control
providers does not
adversely affect the
organization to meet the
requirements of the
FSMS
83 7.1.6 d Retain documented Cf. sub-clause 7.5
information on
evaluation of external
providers
7.2 Competence
84 7.2 a Determine the Identify all the people who influence the
necessary competence performance of the FSMS
85 7.2 b Ensure the persons On the basis of appropriate training and
responsible for the experience
operation of the hazard
control plan are
competent
87 7.2 c Ensure that the food In relation to the development and
safety team has multi- application of the FSMS as processes,
disciplinary competence products, equipment and hazards
86 7.2 d Acquire the necessary And evaluate the effectiveness of actions
competence undertaken
88 7.2 e Retain documented Cf. sub-clause 7.5
information on
competence
7.3 Awareness
89 7.3 a Make all relevant Including people working under the
persons aware of the FS organization's control. Cf. sub-clause 5.2
policy
90 7.3 b Make all relevant Cf. sub-clause 6.2
persons aware of the FS
objectives
91 7.3 c Make all relevant And on the beneficial effects of improving
persons aware of their the performance of the FSMS
contribution
92 7.3 d Make all relevant If not conforming with FSMS requirements,
persons aware to the cf. sub-clauses 8.9 and 10.1
negative impacts
7.4 Communication

7.4.1 General

93 7.4.1 a Determine the On which subjects to

necessary internal and communicate. "Good news walks, bad
external communication news runs". Swedish proverb
relevant to the FSMS
94 7.4.1 b Determine the When to communicate
necessary internal and
external communication
relevant to the FSMS
95 7.4.1 c Determine the With whom to communicate
necessary internal and
external communication
relevant to the FSMS
96 7.4.1 d Determine the How to communicate
necessary internal and
external communication
relevant to the FSMS
97 7.4.1 e Determine the Who will communicate
necessary internal and
external communication
relevant to the FSMS
98 7.4.1 Ensure that the By all persons whose activities have an
requirement for effective impact on food safety
communication is
understood
External
7.4.2
communication
99 7.4.2 Communicate externally Available for interested parties
sufficient information
100 7.4.2 a Communicate effectively Cf. sub-clause 7.1.6
with external providers
101 7.4.2 b 1 Communicate effectively Product information related to food safety
with customers and
consumers
102 7.4.2 b 2 Communicate effectively On food hazards requiring control by other
with customers and companies in the food chain
consumers
103 7.4.2 b 3 Communicate effectively On contractual arrangements, inquiries,
with customers and orders and amendments
consumers
104 7.4.2 b 4 Communicate effectively On customer feedback and complaints
with customers and
consumers
105 7.4.2 c Communicate effectively And regulatory
with statutory authorities
106 7.4.2 d Communicate effectively Regarding the FSMS
with other organizations
107 7.4.2 Designate people with For any information concerning food safety
responsibility and
authority for external
communication
108 7.4.2 Include information Cf. sub-clauses 9.3, 4.4 and 10.3
obtained as input for
management review
and update of the FSMS
109 7.4.2 Retain documented Cf. sub-clause 7.5
information as evidence
of external
communication
Internal
7.4.3
communication
110 7.4.3 Communicate on food Internally
safety
111 7.4.3 a Ensure that the food Regarding products
safety team is informed
of changes
112 7.4.3 b Ensure that the food Regarding raw materials, ingredients and
safety team is informed services
of changes
113 7.4.3 c Ensure that the food Regarding equipment and systems
safety team is informed
of changes
114 7.4.3 d Ensure that the food Regarding premises, location of equipment
safety team is informed and environment
of changes
115 7.4.3 e Ensure that the food regarding cleaning and sanitation
safety team is informed
of changes
116 7.4.3 f Ensure that the food Regarding packaging, storage and
safety team is informed distribution
of changes
117 7.4.3 g Ensure that the food Regarding competence, responsibilities
safety team is informed and authorities
of changes
118 7.4.3 h Ensure that the food Regarding statutory and regulatory
safety team is informed requirements
of changes
119 7.4.3 i Ensure that the food Regarding food safety hazards and control
safety team is informed measures
of changes
120 7.4.3 j Ensure that the food Regarding customer requirements
safety team is informed
of changes
121 7.4.3 k Ensure that the food Regarding information requests from
safety team is informed interested parties
of changes
122 7.4.3 l Ensure that the food Regarding complaints and alerts on food
safety team is informed safety hazards with the end product
of changes
123 7.4.3 m Ensure that the food Regarding other conditions that have an
safety team is informed impact on food safety
of changes
124 7.4.3 Include this information Cf. sub-clauses 4.4 and 10.3
when updating the
FSMS
125 7.4.3 Include this information As input, cf. sub-clause 9.3
to the management
review
Documented
7.5
information
7.5.1 General
126 7.5.1 a Include documented Documented information to maintain
information required by (documented procedures):
the ISO 22000 standard

• 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 "Spoken words fly away, written ones
information deemed stay. Latin proverb"
necessary to the
effectiveness of the
FSMS
128 7.5.1 c Include documented Required by statutory, regulatory
information and food authorities and customers
safety requirements
7.5.2 Creating and updating
129 7.5.2 a Identify and describe Such as title, author, date, coding
documented information
appropriately
130 7.5.2 b Ensure that the format Language, software and graphics version.
and the media of Examples of media: paper, electronic
documented information
are appropriate
131 7.5.2 c Review and approve Who writes, who codify, who approves
documented information
appropriately
Control of
7.5.3 documented
information
132 7.5.3.1 a Control the availability of Where and when it is needed in a form
documented information suitable for use
133 7.5.3.1 b Control the adequate Such as loss of confidentiality, improper
protection of use or loss of integrity
documented information
134 7.5.3.2 a Control the distribution, Who is responsible, methods to use, rules
access and use of to respect
documented information
135 7.5.3.2 b Control the distribution, Including preservation, protection and
access, retrieval and readability
use of documented
information
136 7.5.3.2 c Control the changes of Using updated versions, restricted access
documented information of outdated versions
137 7.5.3.2 d Control the retention Retention and disposition
and disposition of
documented information
138 7.5.3.2 Identify and control Unique codification, access, protection
documented information
of external origin
139 7.5.3.2 Protect documented Who has the right to read, who has the
information retained as right to modify or eliminate
evidence of conformity
Realization of safe
8 Do
products
Operational planning
8.1
and control
140 8.1 a Plan and determine the By establishing process criteria in order to
requirements for the control processes, cf. sub-clauses 4.4 and
realization of safe 6.1
products
141 8.1 b Control processes In accordance with criteria
142 8.1 c Keep documented In order to ensure that the processes have
information on process been carried out as planned. Cf. sub-
control clause 7.5.1
143 8.1 Control planned and By analyzing the consequences of
unintended changes unintended changes, action to mitigate any
adverse effects
144 8.1 Control outsourced Cf. sub-claise 7.1.6
processes
Prerequisite programs
8.2
(PRPs)
145 8.2.1 Control PRPs in the In order to facilitate the prevention of
products, product contamiets
processing and work
environment
146 8.2.2 a Adapt PRPs to the And the context of the organization, cf.
organization sub-clause 4.1
147 8.2.2 b Adapt PRPs to the type And the nature of the products
of operation
148 8.2.2 c Apply the production Programs applicable in general or to a
system at all levels particular product or process
149 8.2.2 d Approve PRPs By the food safety team
150 8.2.3 Identify statutory, When selecting or establishing PRPs
regulatory and customer
requirements
151 8.2.3 a Consider ISO/TS 22002 Only applicable part
series
152 8.2.3 b Consider standards, Such as NF V01-001 and NF V01-006,
codes of practice and European regulations 178/2002, 852/2002,
guidelines 183/2005
153 8.2.4 a Consider, when Buildings and utilities
establishing PRPs
154 8.2.4 b Consider, when Premises, workplaces and facilities
establishing PRPs
155 8.2.4 c Consider, when Supplies of air, water, energy and utilities
establishing PRPs
156 8.2.4 d Consider, when Pest control, waste and sewage disposal
establishing PRPs
157 8.2.4 e Consider, when Equipment and its accessibility for
establishing PRPs cleaning and maintenance
158 8.2.4 f Consider, when Monitoring of external providers
establishing PRPs
159 8.2.4 g Consider, when Reception of incoming materials, storage,
establishing PRPs handling, expedition and transport
160 8.2.4 h Consider, when Prevention measures of cross
establishing PRPs contamination
161 8.2.4 i Consider, when Cleaning and disinfecting
establishing PRPs
162 8.2.4 j Consider, when Personal hygiene
establishing PRPs
163 8.2.4 k Consider, when Product information
establishing PRPs
164 8.2.4 l Consider, when Other elements needed
establishing PRPs
165 8.2.4 Control documented Including selection, establishment,
information on PRPs monitoring and verification, cf. sub-clause
7.5
8.3 Traceability
166 8.3 Be able to identify Including suppliers and distributors
external providers
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, In relation with traceability
regulatory and customer
requirements
171 8.3 Retain documented For a defined period, as a minimum the
information as evidence shelf life of the product, cf. sub-clause 7.5
of the traceability
172 8.3 Verify and test the And its effectiveness
traceability system
8.4 Emergencies
8.4.1 General
173 8.4.1 Prepare for and respond Procedures are in place to respond to
to emergencies everything that can have an impact on
food safety
174 8.4.1 Maintain documented Cf. sub-clause 7.5
information on
emergencies and
incidents
Handling of
8.4.2
emergencies
175 8.4.2 a 1 Respond to emergency By identifying statutory and regulatory
situations and incidents requirements
176 8.4.2 a 2 Respond to emergency By communicating internally appropriate
situations and incidents information
177 8.4.2 a 3 Respond to emergency By communicationg externally appropriate
situations and incidents information to interested parties
(customers, suppliers, authorities, media)
178 8.4.2 b Take appropriate Actions appropriate to the magnitude of
actions to reduce the the situation and the food safety impact
consequences such as natural disasters, interruption of
services such as water, electricity
179 8.4.2 c Simulate test Periodically, where practical
procedures to
emergency situations
180 8.4.2 d Update the documented On any emergency situation or incident
information occurred and realized simulations
8.5 Hazard control
8.5.1 Preliminary steps
8.5.1.1 General
181 8.5.1.1 Collect, maintain and In order to analyze hazards. Done by the
update preliminary food safety team, cf. sub-clause 7.5
documented information
182 8.5.1.1 a Include statutory, Cf. sub-clause 4.2
regulatory and customer
requirements
183 8.5.1.1 b Include products, Provided by the organization
processes and
equipment
184 8.5.1.1 c Include food safety Relevant to the FSMS
hazards
Characteristics of
8.5.1.2
materials
185 8.5.1.2 Identify statutory and For all raw materials, ingredients and
regulatory food safety product contact materials
requirements
186 8.5.1.2 a Maintain documented Such as biological, chemical and physical
information on characteristics, cf. sub-clauses 7.5 and
components in contact 8.5.2
with the product
187 8.5.1.2 b Maintain documented Such as ingredients, additives and
information on processing aids, cf. sub-
components in contact clauses 7.5 and 8.5.2
with the product
188 8.5.1.2 c Maintain documented Such as animal, mineral or vegetable
information on source, cf. sub-clauses 7.5 and 8.5.2
components in contact
with the product
189 8.5.1.2 d Maintain documented Such as place of origin, cf. sub-
information on clauses 7.5 and 8.5.2
components in contact
with the product
190 8.5.1.2 e Maintain documented Such as production method, cf. sub-
information on clauses 7.5 and 8.5.2
components in contact
with the product
191 8.5.1.2 f Maintain documented Such as method of packaging and
information on delivery, cf. sub-clauses 7.5 and 8.5.2
components in contact
with the product
192 8.5.1.2 g Maintain documented Such as storage conditions and shelf life,
information on cf. sub-clauses 7.5 and 8.5.2
components in contact
with the product
193 8.5.1.2 h Maintain documented Such as preparation, handling or
information on processing, cf. sub-clauses 7.5 and 8.5.2
components in contact
with the product
194 8.5.1.2 i Maintain documented Such as food safety accpetance criteria or
information on purchase specifications, cf. sub-
components in contact clauses 7.5 and 8.5.2
with the product
Characteristics of end
8.5.1.3
products
195 8.5.1.3 Identify all statutory and For all the end products
regulatory food safety
requirements
196 8.5.1.3 a Maintain documented Such as product name, cf. sub-
information concerning clauses 7.5 and 8.5.2
the characteristics of
end products
197 8.5.1.3 b Maintain documented Such as composition, cf. sub-
information concerning clauses 7.5 and 8.5.2
the characteristics of
end products
198 8.5.1.3 c Maintain documented Such as biological, chemical and physical
information concerning characteristics, cf. sub-
the characteristics of clauses 7.5 and 8.5.2
end products
199 8.5.1.3 d Maintain documented Such as shelf life and storage conditions,
information concerning cf. sub-clauses 7.5 and 8.5.2
the characteristics of
end products
200 8.5.1.3 e Maintain documented Such as packaging, cf. sub-
information concerning clauses 7.5 and 8.5.2
the characteristics of
end products
201 8.5.1.3 f Maintain documented Such as labeling, and handling,
information concerning preparation and use instructions, cf. sub-
the characteristics of clauses 7.5 and 8.5.2
end products
202 8.5.1.3 g Maintain documented Such as distribution and delivery methods,
information concerning cf. sub-clauses 7.5 and 8.5.2
the characteristics of
end products
8.5.1.4 Intended use
203 8.5.1.4 Consider the intended Including reasonably expected unintended
use and handling of the use and misuse
end product
204 8.5.1.4 Maintain the intended For the hazard analysis, cf. sub-
use as documented clauses 7.5 and 8.5.2
information
205 8.5.1.4 Identify groups of Where appropriate
consumers or users
206 8.5.1.4 Identify groups of To specific food safety hazards
consumers or users
known to be especially
vulnerable
Flow diagrams and
8.5.1.5 description of
processes
Preparation of the flow
8.5.1.5.1
diagrams
207 8.5.1.5.1 Establish, maintain and To be done by the food safety team as
update flow diagrams documented information, cf. sub-
for the processes, clause 7.5
products and product
categories
208 8.5.1.5.1 Use flow diagrams as a In order to evaluate food safety hazards
graphic representation during hazard analysis , cf. sub-clause
of processes 8.5.2
209 8.5.1.5.1 Create clear, accurate In order to carry out a hazard analysis , cf.
and detailed flow sub-clause 8.5.2
diagrams
210 8.5.1.5.1 Include in the flow Steps, sequences and interactions
a diagram
211 8.5.1.5.1 Include in the flow Any outsourced processes, cf. sub-clause
b diagram 7.1.6

212 8.5.1.5.1 Include in the flow Components introduction points (raw

c diagram materials, ingredients, processing aids,
packaging, intermediate products)
213 8.5.1.5.1 Include in the flow Points of reworking and recycling
d diagram
214 8.5.1.5.1 Include in the flow Points of release of end products,
e diagram intermediate products, derivatives and
waste
On-site confirmation
8.5.1.5.2
of flow diagrams
215 8.5.1.5.2 Confirm on-site the To be done by the food safety team
accuracy of the flow
diagrams
216 8.5.1.5.2 Update the flow To be done by the food safety team
diagrams
217 8.5.1.5.2 Retain flow diagrams as Cf. sub-clause 7.5
documented information
Description of
8.5.1.5.3 processes and their
environment
218 8.5.1.5.3 Describe the layout of To be done by the food safety team in
a promises order to carry out an analysis of hazards,
including in handling areas
219 8.5.1.5.3 Describe processing And material flow
b equipment, contact
materials, processing
aids and flow of
materials
220 8.5.1.5.3 Describe existing PRPs, And procedures that can influence food
c process parameters and safety
control measures
221 8.5.1.5.3 Describe external Such as statutory, regulatory and
d requirements that can customers
impact the control
measures
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 Cf. sub-clause 7.5
descriptions of
processes as
documented information
8.5.2 Hazard control
8.5.2.1 General
224 8.5.2.1 Conduct a hazard To be done by the food safety tean in
analysis based on the order to determine hazards to be
preliminary information 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
Hazard identification
8.5.2.2
and acceptable levels
226 8.5.2.2.1 Identify and document In relation to the process, product and the
all food safety hazard 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 Base hazard The preliminary information, cf. sub-
a identification on clause 8.5.1.1
228 8.5.2.2.1 Base hazard The experience of the FS team, staff and
b identification on external experts
229 8.5.2.2.1 Base hazard Internal and external information
c identification on (epidemiological and scientific data)
230 8.5.2.2.1 Base hazard The information of the food chain (food
d identification on safety-related hazards of end products,
intermediate products and at the moment
of consumption)
231 8.5.2.2.1 Base hazard Statutory, regulatory and customer
e identification on requirements and the Codex Alimentarius
Commision
232 8.5.2.2.2 Identify the possible Such as reception, processing, handling,
steps at which each storage, distribution, delivery
hazard can be
introduced
233 8.5.2.2.2 Consider when Stages preceding and following in the food
a identifying hazards chain
234 8.5.2.2.2 Consider when All steps in the flow diagram
b identifying hazards
235 8.5.2.2.2 Consider when People, equipment, services and process
c identifying hazards environment
236 8.5.2.2.3 Determine the In the end product
acceptable level of each
food safety hazard
identified
237 8.5.2.2.3 Identify statutory, When determining acceptable levels
a regulatory and customer
requirements
238 8.5.2.2.3 Consider the intended When determining acceptable levels
b use
239 8.5.2.2.3 Consider any other When determining acceptable levels
c relevant information
240 8.5.2.2.3 Maintain documented And the justification for the acceptable
information on levels, cf. sub-clause 7.5
acceptable levels
8.5.2.3 Hazard assessment
241 8.5.2.3 Conduct a hazard In order to determine the need for
assessment for each prevention or reduction
identified hazard
242 8.5.2.3 a Evaluate each food With regard to the likelihood of its
safety hazard occurrence prior to the application of
control measures
243 8.5.2.3 b Evaluate each food With regard to the severity of its adverse
safety hazard health effects in relation to the intended
use, cf. 8.5.1.4
244 8.5.2.3 Identify any significant In relation to food safety
hazards
245 8.5.2.3 Describe the Cf. sub-clause 7.5
methodology used and
maintain the results of
the hazard assessment
as documented
information

8.5.2.4 Control measures

246 8.5.2.4.1 Select a control In order to prevent or reduce significant

measure or combination food safety hazards to an acceptable level,
of control measures cf. sub-clause 8.5.2.3
based on the hazard
assessment
247 8.5.2.4.1 Categorize the control Cf. sub-clause 8.5.4
measures in oPRP or
CCP
248 8.5.2.4.1 Carry out the Using a systematic approach
categorization of control
measures
249 8.5.2.4.1 Assess for each control The likelihood of failure of its functioning
a measure selected
250 8.5.2.4.1 Assess for each control The severity of the consequences of
b1 measure selected failure including the impact on significant
food safety hazards
251 8.5.2.4.1 Assess for each control The severity of the consequences of
b2 measure selected failure including the location in relation to
other control measures
252 8.5.2.4.1 Assess for each control The severity of the consequences of
b3 measure selected failure including whether the measure will
reduce the hazards to an acceptable level
253 8.5.2.4.1 Assess for each control The severity of the consequences of
b4 measure selected failure including whether it is a single
measure or is part of combination of
control measures
254 8.5.2.4.2 Include an assessment Establishing measurable critical limits and
a of the feasibility for each measurable action criteria (observable)
control measure
255 8.5.2.4.2 Include an assessment Monitoring to detect any failure to remain
b of the feasibility for each within critical limits or measurable action
control measure criteria
256 8.5.2.4.2 Include an assessment Applying timely corrections
c of the feasibility for each
control measure
257 8.5.2.4.2 Maintain the decision- Cf. sub-clause 7.5
making process, results
of the selection and
categorization of the
control measures as
documented information
258 8.5.2.4.2 Maintain external Requirements such as statutory,
requirements as regulatory and customer, that can impact
documented information the selection and strictness of the control
measures, cf. sub-clause 7.5
Validation of control
8.5.3 measures and their
combinations
259 8.5.3 Validate the selected By the food safety team
control measures that
are capable of achieving
the intended control of
significant food safety
hazards
260 8.5.3 Conduct validation prior Including validation in the hazard control
to implementation of plan, cf. sub-clause 8.5.4 and following
control measure or any change of the plan, cf. sub-clauses
combination of control 7.4.2, 7.4.3, 10.2 and 10.3
measures
261 8.5.3 Re-assess the control By the food safety team
measures when the
 result of validation
shows that the control
measures are not
capable of achieving the
intended control
262 8.5.3 Maintain the validation By the food safety team, cf. sub-clause 7.5
methodology and
evidence of capability of
the control measures to
achieve the intended
control as documented
information
Hazard control plan
8.5.4
(HACCP/oPRP plan
8.5.4.1 General
263 8.5.4.1 Establish, implement By the food safety team
and maintain a hazard
control plan
264 8.5.4.1 Maintain the hazard Cf. sub-clause 7.5
control plan as
documented information
265 8.5.4.1 a Include in the hazard The food safety hazards have to be
control plan controlled at the CCP level or through
oPRP
266 8.5.4.1 b Include in the hazard Critical limits at CCP or action criteria for
control plan oPRP
267 8.5.4.1 c Include in the hazard Monitoring procedures
control plan
268 8.5.4.1 d Include in the hazard Corrections to undertake in case critical
control plan limits or action criteria are not met
269 8.5.4.1 e Include in the hazard Responsibilities and authorities
control plan
270 8.5.4.1 f Include in the hazard Records (documented information to
control plan retain) of monitoring, cf. sub-clause 7.5
Critical limits and
8.5.4.2
action criteria
271 8.5.4.2 Specify critical limits and At CCPs and for oPRPs
action criteria
272 8.5.4.2 Maintain the rationale Cf. sub-clause 7.5
for their determination
 as documented
information
273 8.5.4.2 Use measurable critical By the food safety team
limits at CCPs
274 8.5.4.2 Ensure that the Conformance with critical limits
acceptable level is not
exceeded
275 8.5.4.2 Use measurable action Or observable
criteria for oPRPs
276 8.5.4.2 Ensure that the Conformance with action criteria
acceptable level is not
exceeded
8.5.4.3 Monitoring systems
277 8.5.4.3 Establish at each CCP a In order to detect any failure to remain
monitoring system for within critical limits
each control measure or
combination of control
measures
278 8.5.4.3 Include in the monitoring Relative to critical limits
system all scheduled
measurements
279 8.5.4.3 Establish for each oPRP In order to detect any failure to remain
a monitoring system for within action criteria
each control measure or
combination of control
measures
280 8.5.4.3 a Include in the monitoring On results of measurements or
system documented observation within an adequate time
information frame, cf. sub-clause 7.5
281 8.5.4.3 b Include in the monitoring On monitoring methods or devices used,
system documented cf. sub-clause 7.5
information
282 8.5.4.3 c Include in the monitoring On calibration methods or equivalent
system documented methods, cf. sub-clause 7.5
information
283 8.5.4.3 d Include in the monitoring On monitoring frequency, cf. sub-
system documented clause 7.5
information
284 8.5.4.3 e Include in the monitoring On monitoring results, cf. sub-clause 7.5
system documented
information
285 8.5.4.3 f Include in the monitoring On monitoring responsibilities and
system documented authorities
information
286 8.5.4.3 g Include in the monitoring On responsibilities and authorities related
system documented to evaluation of monitoring results
information
287 8.5.4.3 Allow each CCP to In order to isolate and evaluate the
quickly detect any product, cf. sub-clause 8.9.4.1
failure to remain within
critical limits
288 8.5.4.3 Use monitoring method And the severity of consequences
and frequency for each
oPRP proportionate to
the likelihood of failure
289 8.5.4.3 Support the monitoring By instructions or specifications
method of an oPRP
based on observation
data as a visual
inspection
Actions when critical
8.5.4.4 limits or action criteria
are not met
290 8.5.4.4 Specify corrections and Cf. sub-clauses 8.9.2 and 8.9.3
corrective actions to be
taken when critical limits
and action criteria are
not met
291 8.5.4.4 a Ensure that potentially Cf. sub-clause 8.9.4.1
unsafe products are not
released
292 8.5.4.4 b Identify the cause of Cf. sub-clause 8.9.3
nonconformity
293 8.5.4.4 c Ensure that again the Cf. sub-clause 9.1
critical limits and action
criteria are met
294 8.5.4.4 d Ensure that recurrence Cf. sub-clause 8.9.3
is preventedMake
corrections and
corrective actions
295 8.5.4.4 Make corrections and In accordance with sub-
corrective actions clauses 8.9.2 and 8.9.3
 Implementation of the
8.5.4.5
hazard control plan
296 8.5.4.5 Implement and maintain Cf. sub-clause 8.5.4.1
the hazard control plan
297 8.5.4.5 Retain evidence of the Cf. sub-clause 7.5
implementation of the
hazard control plan as
documented
information
Update of PRPs and
8.6 the hazard control
plan
298 8.6 a Update, if necessary, Characteristics of product-contact
the information materials, cf. sub-clause 8.5.1.2
specifying the PRPs and
the hazard control plan
299 8.6 b Update, if necessary, Characteristics of end product, cf. sub-
the information clause 8.5.1.3
specifying the PRPs and
the hazard control plan
300 8.6 c Update, if necessary, Intended use, cf. sub-clause 8.5.1.4
the information
specifying the PRPs and
the hazard control plan
301 8.6 d Update, if necessary, Flow diagrams, descriptions of processes
the information and process environment, cf. sub-clause
specifying the PRPs and 8.5.1.5.1
the hazard control plan
302 8.6 Ensure that the hazard Cf. sub-clauses 8.5.4 and 8.2
control plan and the
PRPs are updated
Control of monitoring
8.7
and measuring
303 8.7 Provide evidence that Equipment in use
the specified monitoring
and measuring methods
are adequate related to
the PRPs and the
hazard control plan
304 8.7 a Use appropriate Calibrated and verified regularly
monitoring and
measuring equipment
305 8.7 b Use appropriate Adjusted as many times as needed
monitoring and
measuring equipment
306 8.7 c Use appropriate Identified (with calibration date)
monitoring and
measuring equipment
307 8.7 d Use appropriate Protected against ill-fitting
monitoring and
measuring equipment
308 8.7 e Use appropriate Protected against deterioration
monitoring and
measuring equipment
309 8.7 Retain the results of Cf. sub-clause 7.5
calibration and
verification as
documented information
310 8.7 Base calibration on National or international
standards
311 8.7 Retain the basis used When no standard exists, cf. sub-
for calibration or clause 7.5
verification as
documented information
312 8.7 Assess the validity of When the equipment or the process
the previous results environment is not conforming
313 8.7 Take appropriate action On nonconforming equipment or process
environment
314 8.7 Maintain the Cf. sub-clause 7.5
assessment and
resulting action as
documented information
315 8.7 Validate software used By the organization, the supplier or third
in monitoring and party
measuring prior to use
316 8.7 Maintain validation Cf. sub-clause 7.5
activities as
documented information
317 8.7 Update the software in a With the software supplier
timely manner
318 8.7 Authorize, document Prior implementation
and validate software
changes
 Verification of PRPs
8.8 and hazard control
plan
8.8.1 Verification
319 8.8.1 Establish, implement "Inspection does not improve quality,
and maintain verification nor guarantee quality. Edwards
activities Deming"
320 8.8.1 Define purpose, This is part of verification planning
methods, frequencies
and responsibilities for
the verification activities
321 8.8.1 a Include in verification The implementation and effectiveness of
activities PRPs
322 8.8.1 b Include in verification The implementation and effectiveness of
activities the hazard control plan
323 8.8.1 c Include in verification The state of acceptable hazard levels
activities
324 8.8.1 d Include in verification Updating input to the hazard analysis
activities
325 8.8.1 e Include in verification The implementation and effectiveness of
activities other actions
326 8.8.1 Ensure that verification "No one is a judge in his own case.
activities are not carried Latin proverb"
out by the person
responsible for
monitoring these
activities
327 8.8.1 Retain verification And communicate them, cf. sub-clauses
results as documented 7.4 and 7.5
information
328 8.8.1 Handle products as When the verification found nonconforming
potentially unsafe and samples (non-acceptable level of the food
apply corrective actions safety hazard), cf. sub-clauses 8.5.2.2,
8.9.4.3 and 8.9.3
Analysis of
8.8.2
verification activities
329 8.8.2 Conduct an analysis of Cf. sub-clause 9.1.2
the results of verification
and use as an input to
the performance
evaluation of the FSMS
 Control of
8.9
nonconformities
8.9.1 General
330 8.9.1 Ensure that the results And who has the authority to initiate
from the monitoring of corrections and corrective actions, cf. sub-
oPRPs and at CCPs are clauses 8.9.2 and 8.9.3
evaluated by competent
persons
8.9.2 Corrections
331 8.9.2.1 Identify and control When critical limits at CCPs or action
nonconforming products criteria for oPRPs are not met
with corrections
332 8.9.2.1 a Include in established, A method of identification, assessment
maintained and updated and correction for affected products in
documented information order to ensure their proper handling, cf.
sub-clause 7.5
333 8.9.2.1 b Include in established, Arrangements for review of corrections
maintained and updated
documented information
334 8.9.2.2 Identify products when Considering them as unsafe products, cf.
critical limits at CCP are sub-clause 8.9.4.1
not met
335 8.9.2.3 a Carry out actions where By determining the food safety
action criteria for an consequences
oPRP are not met
336 8.9.2.3 b Carry out actions where By determining the causes
action criteria for an
oPRP are not met
337 8.9.2.3 c Carry out actions where By identifying the products concerned and
action criteria for an their handling, cf. sub-clause 8.9.4.1
oPRP are not met
338 8.9.2.3 Retain results of the Cf. sub-clause 7.5
evaluation as
documented information
339 8.9.2.4 a Retain results of The nature of the nonconformity, cf. sub-
corrections as clause 7.5
documented information
340 8.9.2.4 b Retain results of The causes of the nonconformity, cf. sub-
corrections as clause 7.5
documented information
341 8.9.2.4 c Retain results of The consequences of the nonconformity,
corrections as cf. sub-clause 7.5
documented information
8.9.3 Corrective actions
342 8.9.3 Evaluate the need for When critical limits at CCPs or action
corrective actions criteria for oPRPs are not met
343 8.9.3 Establish and maintain In order to prevent recurrence of
documented information nonconformities, cf. sub-clause 7.5
on the control of
nonconformities
344 8.9.3 a Include in corrective Reviewing nonconformities following
actions complaints or regulatory reports
345 8.9.3 b Include in corrective Reviewing trends in monitoring that can
actions indicate loss of control
346 8.9.3 c Include in corrective Determining the root causes of
actions nonconformities
347 8.9.3 d Include in corrective Determining and implementing actions in
actions order to ensure that nonconformities will
not recur
348 8.9.3 e Include in corrective Documenting the results, cf. sub-
actions clause 7.5
349 8.9.3 f Include in corrective Verifying the effectiveness of actions
actions
350 8.9.3 Retain documented Cf. sub-clause 7.5
information on
corrective actions
Handling of potentially
8.9.4
unsafe products
8.9.4.1 General
351 8.9.4.1 a Undertake actions to Food safety hazards are reduced to
prevent the entry of acceptable levels
potentially unsafe
products into the food
chain unless
352 8.9.4.1 b Undertake actions to Food safety hazards will be reduced to
prevent the entry of acceptable levels prior to entering the food
potentially unsafe chain
products into the food
chain unless
353 8.9.4.1 c Undertake actions to The product still meets the defined
prevent the entry of acceptable level despite the nonconformity
 potentially unsafe
products into the food
chain unless
354 8.9.4.1 Retain the control of Until the products are evaluated and their
products that have been disposition determined, cf. sub-clause
identified as potentially 8.9.4.3
unsafe
355 8.9.4.1 Notify relevant Initiate a withdrawal or recall, cf. sub-
interested parties if clause 8.9.5
products are
subsequently
determined to be unsafe
356 8.9.4.1 Retain feedback from Cf. sub-clause 7.5
interested parties and
authorization for dealing
with potentially unsafe
products as
documented information
8.9.4.2 Evaluation for release
357 8.9.4.2 Evaluate each lot of Concerning all unsafe products
products including
nonconformities
358 8.9.4.2 Handle products with Do not release but handled in accordance
critical limits at CCPs with sub-clause 8.9.4.3
not met
359 8.9.4.2 a Release products as Monitoring demonstrates that the control
safe but affected by measures are effective
failure to meet action
criteria for oPRPs
provided that
360 8.9.4.2 b Release products as The combined effect of the control
safe but affected by measures conforms to the performance
failure to meet action intended (identified acceptable levels)
criteria for oPRPs
provided that
361 8.9.4.2 c Release products as The results of sampling, analysis or other
safe but affected by verification activities demonstrate that the
failure to meet action products conform to the identified
criteria for oPRPs acceptable levels
provided that
362 8.9.4.2 Retain evaluation for Cf. sub-clause 7.5
release of products as
documented information
Disposition of
8.9.4.3 nonconforming
products
363 8.9.4.3 a Submit to a new In order to reduce food safety hazard to an
transformation products acceptable level
that are not acceptable
for release
364 8.9.4.3 b Redirect for other use As long as food fasety in the food chain is
products that are not not affected
acceptable for release
365 8.9.4.3 c Destroy or dispose As waste
products that are not
acceptable for release
366 8.9.4.3 Retain the disposition of Including the person with approving
nonconforming products authority, cf. sub-clause 7.5
as documented
information
8.9.5 Withdrawal or recall
367 8.9.5 Ensure the timely By appointing a person having the
withdrawal or recall of authority to initiate and carry out the
any lot identified as withdrawal or recall
potentially unsafe
368 8.9.5 a Maintain documented Notify interested parties (authorities,
information for customers, consumers), cf. sub-clause 7.5
369 8.9.5 b Maintain documented Handling withdrawn, recalled or still in
information for stock products, cf. sub-clause 7.5
370 8.9.5 c Maintain documented Performing actions to be taken, cf. sub-
information for clause 7.5
371 8.9.5 Secure products Until they are managed in accordance with
withdrawn, recalled or sub-clause 8.9.4.3
still in stock
372 8.9.5 Retain the cause, extent Cf. sub-clause 7.5
and result of a
withdrawal and recall
as documented
information
373 8.9.5 Report withdrawal and Cf. sub-clause 9.3
recall information as
 input to the
management review
374 8.9.5 Verify the Such as simulations or pratical test
implementation and
effectiveness of
withdrawals and recalls
through the use of
appropriate techniques
375 8.9.5 Retain the verification of Cf. sub-clause 7.5
the implementation and
effectiveness of
withdrawals and
recalls as documented
information
Performance
9 Check
evaluation
Monitoring,
measurement,
9.1 analysis and
performance
evaluation
9.1.1 General
376 9.1.1 a Determine what needs "If you can't measure it, you can't
to be inspected manage it. Peter Drucker"
(monitored and
measured)
377 9.1.1 b Determine the methods In order to ensure valid results
for inspection, analysis
and evaluation
378 9.1.1 c Determine when to At essential steps or following a customer
inspect request
379 9.1.1 d Determine when to When it brings added value
analyze and evaluate
the results of inspection
380 9.1.1 e Determine who shall Responsibilities and authorities, cf. sub-
analyze and evaluate clause 5.3
the results of inspection
381 9.1.1 Retain inspection results Cf. sub-clause 7.5
as documented
information
382 9.1.1 Evaluate the In order to guarantee safe food at all times
performance and
 effectiveness of the
FSMS
Analysis and
9.1.2
evaluation
383 9.1.2 Analyze and evaluate Including the results of verification
the results of monitoring activities related to PRPs and the hazard
and measurement control plan and audits, cf. sub-clauses
8.8, 8.5.4 and 9.2
384 9.1.2 a Confirm that the overall By conducting an analysis of the
performance of the management system
organization meets the
FSMS requirements
385 9.1.2 b Identify the need for By conducting an analysis of the
updating or improving management system, cf. sub-clauses 10.2
the FSMS and 10.3
386 9.1.2 c Identify rate trends of By conducting an analysis of the
potentially unsafe management system
products or process
failures
387 9.1.2 d Plan the audit program By conducting an analysis of the
related to the status and management system
importance of areas to
be audited
388 9.1.2 e Provide evidence that By conducting an analysis of the
corrections and management system
corrective actions are
effective
389 9.1.2 Retain the results of the Cf. sub-clause 7.5
analysis and the
resulting activities as
documented information
390 9.1.2 Report the results as Cf. sub-clauses 9.3 and 10.3
input to the
management review
and the updating of the
FSMS
9.2 Internal audit
391 9.2.1 a 1 Conduct regularly In order to determine whether the FSMS
planned internal audits conforms to the internal requirements of
the organization. Cf. ISO 19011
392 9.2.1 a 2 Conduct regularly In order to determine whether the FSMS
planned internal audits conforms to the requirements of ISO
22000
393 9.2.1 b Conduct regularly In order to determine whether the FSMS is
planned internal audits effective and updated
394 9.2.2 a Plan, establish, Including the frequency, methods,
implement and update responsibilities, planning requirements
an internal audit (audit program) and the requirements for
program reporting (audit report)
395 9.2.2 a Take into account in the Essential points such as:
audit program the
importance of the • process importance
processes concerned • changes in the FSMS
• the results of:
o monitoring
o measurement
o 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 Cf. sub-clause 7.4
of the audits are
communicated to the
food safe team and top
management
399 9.2.2 e Retain documented Cf. sub-clause 7.5
information on the
application of the audit
program and audit
results
400 9.2.2 f Undertake corrections Cf. sub-clauses 8.9.2 and 8.9.3
quickly and corrective
actions, if necessary
401 9.2.2 g Determine if the FSMS Cf. sub-clauses 5.2 and 6.2
meets the food safety
policy and objectives
 9.3 Management review
9.3.1 General
402 9.3.1 Review the FSMS at In order to confirm its suitability, adequacy
least once a year and effectiveness. "No system is
perfect"
Management review
9.3.2
input
403 9.3.2 a Conduct management Considering the status of actions from
review previous management reviews
404 9.3.2 b Conduct management Considering changes in external and
review internal issues of the FSMS, including
changes in the organization and its context
405 9.3.2 c 1 Take into account On update of the FSMS, cf. sub-clauses
information on the 4.4 and 10.3
performance and the
effectiveness of the
FSMS and trends
406 9.3.2 c 2 Take into account Results of inspection, cf. sub-clause 9.1
information on the
performance and the
effectiveness of the
FSMS and trends
407 9.3.2 c 3 Take into account Results of verification of PRPs and the
information on the hazard control plan, cf. sub-clause 8.8.2
performance and the
effectiveness of the
FSMS and trends
408 9.3.2 c 4 Take into account Nonconformities and corrective actions, cf.
information on the sub-clauses 8.9.2 and 8.9.3
performance and the
effectiveness of the
FSMS and trends
409 9.3.2 c 5 Take into account Audit results, cf. sub-clause 9.2
information on the
performance and the
effectiveness of the
FSMS and trends
410 9.3.2 c 6 Take into account Regulatory and customer inspections
information on the
performance and the
effectiveness of the
FSMS and trends
411 9.3.2 c 7 Take into account The performance of external providers, cf.
information on the sub-clause 7.1.6
performance and the
effectiveness of the
FSMS and trends
412 9.3.2 c 8 Take into account The review of risks, cf. sub-clause 6.1
information on the
performance and the
effectiveness of the
FSMS and trends
413 9.3.2 c 9 Take into account The extent to which objectives of the
information on the FSMS are met, cf. sub-clause 6.2
performance and the
effectiveness of the
FSMS and trends
414 9.3.2 d Take into account the The adequacy of resources, cf. sub-clause
resources 7.1
415 9.3.2 e Take into account any Including incidents, cf. sub-clauses 8.4.2
emergency situation, and 8.9.5
withdrawal or recall
416 9.3.2 f Take into account Including complaints, cf. sub-clauses 7.4.2
feedback from external and 7.4.3
or internal origin
417 9.3.2 g Take into account Continual improvement, cf. sub-clause
opportunities for 10.2
improvement
418 9.3.2 Present this data in a Cf. sub-clause 6.2
manner that enables top
management to
associate it with food
safety objectives
Management review
9.3.3
output
419 9.3.3 a Include in the output of Cf. sub-clause 10.2
the management review
decisions and actions
related to continual
improvement
opportunities
420 9.3.3 b Include in the output of Such as resources, fod safety policy and
the management review objectives, cf. sub-clauses 7.1, 5.2 and 6.2
decisions related to any
 need for changes to the
FSMS
421 9.3.3 Retain the results of the Cf. sub-clause 7.5
management review as
documented information
10 Improvement Act
10.1 Nonconformities
422 10.1.1 a React to the By controlling it and correcting it. "Where
1 nonconformities there is a problem, there is potential for
improvement. Masaaki Imai"
423 10.1.1 a React to the By dealing with the consequences
2 nonconformities
424 10.1.1 b Evaluate the need for By reviewing the nonconformity
1 action to eliminate the
root causes
425 10.1.1 b Evaluate the need for By researching and analyzing the root
2 action to eliminate the causes of nonconformity
root causes
426 10.1.1 b Evaluate the need for By researching similar nonconformity of
3 action to eliminate the the past or the future
root causes
427 10.1.1 c Undertake any action In order to treat the nonconformity
needed
428 10.1.1 d Review the in order to verify whether the action is
effectiveness of completed
corrective actions
429 10.1.1 e Make changes to the If necessary
FSMS
430 10.1.1 React proportionally to Do not go overboard on quality
the consequences of
nonconformities
431 10.1.2 a Retain evidence of the Cf. sub-clause 7.5
nature of the
nonconformities as
documented information
432 10.1.2 b Retain the results of Cf. sub-clause 7.5
action as documented
information
Continual
10.2
improvement
433 10.2 Improve continually the By finding improvement opportunities
performance of the
FSMS
434 10.2 Ensure continual Cf. sub-clause 7.4
improvement of the
effectiveness of the
FSMS through
communication
435 10.2 Ensure continual Cf. sub-clause 9.3
improvement of the
effectiveness of the
FSMS through
management review
436 10.2 Ensure continual Cf. sub-clause 9.2
improvement of the
effectiveness of the
FSMS through internal
audit
437 10.2 Ensure continual Cf. sub-clause 8.8.2
improvement of the
effectiveness of the
FSMS through analysis
of results of verification
activities
438 10.2 Ensure continual Cf. sub-clause 8.5.3
improvement of the
effectiveness of the
FSMS through
validation of control
measures
439 10.2 Ensure continual Cf. sub-clause 8.9.3
improvement of the
effectiveness of the
FSMS through
correctives actions
440 10.2 Ensure continual Cf. sub-clause 10.3
improvement of the
effectiveness of the
FSMS through FSMS
updating
10.3 Update of the FSMS
441 10.3 Ensure that the FSMS is Permanently
updated
442 10.3 Evaluate the FSMS at By the food safety team
planned intervals
443 10.3 Evaluate the need to Cf. sub-clause 8.5.2
review the hazard
analysis
444 10.3 Evaluate the need to Cf. sub-clause 8.5.4
review the hazard
control plan
445 10.3 Evaluate the need to Cf. sub-clause 8.2
review the PRPs
446 10.3 a Base updating activities Cf. sub-clause 7.4
on communication
447 10.3 b Base updating activities In relation with the suitability, adequacy
on any othe information and effectiveness
448 10.3 c Base updating activities Cf. sub-clause 9.1.2
on results of verification
activities
449 10.3 d Base updating activities Cf. sub-clause 9.3
on decisions from
management review
450 10.3 Retain system updating Cf. sub-clause 7.5
activities as
documented information
451 10.3 Report system updating Cf. sub-clause 9.3
activities as input to the
management review