Welcome back
to this blog. I hope the approach used here to break down and
analyze the different requirements of these management system standards will help to reinforce your understanding of the
different requirements somewhat. I hope this information is of interest
to you.
In previous entries we dealt with the requirements corresponding to Section
5.2.1-Establishing the food safety policy, and we did so in two parts, due to the importance and complexity of
the requirements derived from said section, as well as the requirements derived from Section 5.2.2 –
Communicating the food safety policy.
On this
occasion we will focus on analyzing the requirements derived from the last sub-clause of those that
make up Clause 5 - Leadership, and I am referring to Subclause
5.3 - Organizational roles, responsibilities and authorities.
As I have
explained to you in a previous entry, the food safety policy is the most important element of a food safety
management system, because all
the processes and activities carried
out by the organization within that FSMS will be to comply with the aforementioned policy. That is why in this group of requirements of this standard, derived from Section 5.2.2, all of them refer to this food safety
policy, specifying how, and to whom, this element of the food safety
management system should be communicated.
In that Section 5.2.2, the ISO 22000:2018 Standard establishes a series of requirements, all directed to top management, since if you remember, we are still analyzing Clause 5 - Leadership, and all requirements that derive from this Sub-clause 5.3 refer to the exercise of leadership by top management to assign responsibilities and authorities at all
levels of the organization. Below I
present to you the list of these requirements derived from Sub-clause 5.3, and I present them with the corresponding
progressive numbering, as we have been presenting, individually, all requirements of this ISO 22000 Standard that have been analyzed:
If we apply
the appropriate correction corresponding to ISO 22000 Standard, the Technical Specification TS 9002:2016 - Quality
management systems — Guidelines for the application of the ISO 9001:2015
Standard, in relation to this Subclause 5.3 - Organizational roles,
responsibilities and authorities, mentions that the intent of this sub-clause is for top
management to assign relevant roles related to food safety
management system, in order to
ensure effectiveness and the
achievement of intended results. Top
management will need to
establish specific responsibilities and authorities for those roles, and ensure that people in the organization understand and are aware of their assignments
through effective communication
activities.
It also
indicates that responsibilities and authorities can be assigned to one or more people. They should
be able to make decisions and effect changes in the area and/or processes to which they have been
assigned. It is essential to emphasize that although authority may be delegated, overall responsibility and accountability for the food safety management system remains with top management.
It mentions
that in some organizations there may be
a limited number of people available with the necessary competence to carry out
the required tasks; it might be helpful to plan so that roles, responsibilities and authorities are shared.
Such plans are valuable during
vacations, when managers are not on site, or in cases of accident or illness.
Top management, in accordance with TS 9002: 2016, should determine the manner in which relevant roles, responsibilities and authorities are
communicated. This could be done through the use of relevant documented information, e.g. job
descriptions, work instructions, duty statements, organizational charts, manuals, procedures.
The responsibilities and authorities to be assigned by top management to the relevant
roles within the food safety management system are closely linked, but are not the same, and are
therefore presented here as different elements of different requirements.
If there are
several people who carry out the same role
within the FSMS, the
responsibilities assigned to them should be practically the same, for the performance
of their roles, but in the case of the assignment
of authorities, the situation
changes, since the top management should decide to whom of these people will assign the necessary authorities to make decisions and give orders to others.
In accordance
with the list of requirements presented above, the next one to be analyzed, first of this sub-clause, is the following:
Requirement No. 86: Top management shall ensure that the responsibilities for relevant roles are assigned within the organization.
What this requirement points out is that top management should first identify which
are all relevant roles to the food safety management system.
As you may have noticed, this standard includes commonly used
terms, but there are some of them that supposedly we all clearly understand,
but in fact each person understands those in a different way.
That is why it is convenient for us to look
for a dictionary and use it to find the definitions of these types of terms
that can cause confusion if we do not understand and use them in the same way.
For example, among the terms that can cause
this type of confusion, we have the following:
In light of this definition, the organization should identify all
activities that are performed by one or more persons, for a particular
operation or process that is relevant to the food safety management system. It is worth clarifying
that, for this task, it is generally not convenient to include all the roles
or functions that are performed in the organization, but only those that are
relevant to this system. Among the roles
that most organizations can identify, that are
relevant to the FSMS, we could mention the
following: food system
team leader, food system team members, processes owners,
processes operators, those who create documented information,
those who update it, those who control documented information, those who
generate records (documented information as evidence of conformity), those who maintain records
(documented information maintained as evidence of conformity), inspectors, supervisors, verifiers, internal
auditors, those who identify and document non conformities, those who initiate corrective actions, those who plan, carry out, verify and
close corrective
actions, among others.
Once we have identified what the term "role" means, in order to
identify the pertinent roles of the FSMS, it is convenient to
consult other definitions, such as those presented below:
We can understand, then, that once top management has identified all these relevant
roles, it should ensure that, through the deployment of its entire chain of
responsibility and authority, each of these relevant
roles for the FSMS have been assigned their corresponding responsibilities, that is, that it has
been indicated, for each of these roles, all the obligations that
correspond to it for the fulfillment of the duty.
There is a situation that is worth rising so
that it is well understood, as we saw it in TS 9002:2016. Even though responsibilities should be assigned
for all relevant roles within the FSMS, top management cannot delegate these responsibilities, they can only share
them, but this top
management will always have primary responsibility and accountability for the food safety
management system.
When assigning responsibilities for the relevant
roles within the food safety management system, top management should take into account
that those responsibilities should be clearly
assigned to each role and should be sufficient for the person(s) to whom
they are going to assign, be able to fulfill the entrusted role.
Requirement
No. 87: Top management shall ensure that the responsibilities for relevant
roles are communicated within the organization.
In accordance with this requirement, top management should ensure that, once responsibilities for relevant roles
to the FSMS are assigned, they are
communicated throughout the organization.
To achieve this, it will be important for the organization to present these assigned responsibilities as documented
information, either generally in a food safety manual, on a web
page, or as the organization has arranged to present and describe its food safety
management system, so that all personnel have access to this
information, and it can also be done in a more specific and better described
way in documentation of processes, procedures or work
instructions.
This ensures that the personnel who carry out
these types of roles for the FSMS clearly know what
activities they are responsible for carrying out, and that all personnel know
who carries out those relevant roles of the FSMS and what their
corresponding responsibilities
are.
Requirement
No. 88: Top management shall ensure that the responsibilities for relevant
roles are understood within the organization.
The intent of this requirement is to ensure that all
personnel have a proper understanding of what those relevant roles are, and
what are those responsibilities associated with each of
these roles.
Top management will need to establish
specific responsibilities for those roles,
and ensure that people in the organization understand and are aware of those assignments,
in order to ensure the effectiveness of the FSMS and the achievement of
the intended
results.
That is why top management should establish
mechanisms to ensure that all staff understands these responsibilities, such as informational
meetings, workshops, seminars, evaluations, among others, and generate evidence
of understanding of said responsibilities, at the level of understanding that it deems
appropriate to estimate that they have been understood by the entire staff of
the organization.
Requirement
No. 89: Top management shall ensure that the authorities for relevant roles are assigned within the organization.
To better understand this requirement, it is convenient to
also present the definition of the term “authority”.
Once top management has identified all the relevant
roles for the FSMS, it should ensure that, through the deployment of its entire chain of responsibility and authority, each of these roles
has been assigned its corresponding authorities, that is, that it has
been pointed out, for each of these roles, all the official power to
make decisions for other people or to tell them what they must do, in their
delimited scope.
As we have seen, when an authority is assigned to a
specific role, it is granted the right to give orders or make decisions,
within what corresponds to said role. Contrary to what is indicated in requirement No. 116, concerning the case of responsibility, the authority is delegated.
When assigning authorities to the relevant roles
within the food safety management system, top management should take into account
that these authorities should be clearly assigned
to each role and should be sufficient for the person(s) to whom they are going
to assign, be able to fulfill the entrusted authority. No more, no less.
Requirement
No. 90: Top management shall ensure that the authorities for relevant roles are communicated within
the organization.
In accordance with this requirement, top management should ensure that, once authorities are assigned for
the relevant roles to the FSMS, they are communicated
to the entire organization.
To achieve this, it will be important for the organization to present these assigned authorities as documented
information, either generally in a quality manual, on a web page, or
as the organization has arranged to present
and describe its food safety management system, so that all personnel
have access to this information, and it can also be done in a more specific and
better described way in documentation of processes, procedures or work
instructions.
With this, it is ensured that the personnel
who carry out these types of roles for the FSMS know what activities they
are responsible for carrying out, and
that all personnel know who carries out those relevant roles of the management system and who their
corresponding authorities are.
Requirement
No. 91: Top management shall ensure that the authorities for relevant roles are understood within the organization.
The intent of this requirement is to ensure that all
personnel have a proper understanding of what those relevant roles are, and
what are those authorities associated with each of
these roles.
Top management will need to establish
specific authorities for those relevant roles,
and ensure that people in the organization understand and are aware of those assignments,
in order to ensure the effectiveness of the FSMS and the achievement of
the intended
results.
That is why top management should
establish mechanisms to ensure that
all staff understands these authorities, such as briefings, workshops, seminars,
evaluations, among others, and generate evidence of understanding of said authorities, at the level of
understanding that it deems appropriate to estimate that they have been
understood by the entire staff of the organization.
Requirement
No. 92: Top management shall assign the responsibility for ensuring that the FSMS conforms to the requirements of this document.
Top management should
assign for one or more persons
the responsibility that the food safety
management system conforms to requirements of this ISO
22000:2018 standard, to ensure that the FSMS considers all the specific
roles necessary, such as internal
auditors, or for management
review, among others, not only regarding the roles of the food safety team. In the event that this authority is assigned to
more than one person, it will be important to define their areas of action, so
that there is no interference between them.
Requirement
No. 93: Top management shall assign the authority for ensuring that the FSMS conforms to the requirements of this document.
Top management should
assign for one or more persons
the authority for the food safety
management system to conform to requirements of this ISO
22000:2018 standard, to ensure that the QMS considers all
specific roles required, such as internal
auditors, or for management
review, among others, not only regarding the roles of the food safety team. In the event that this authority is assigned to
more than one person, it will be important to define their areas of action, so
that there is no interference between them.
Requirement
No. 94: Top management shall assign the responsibility for reporting on the performance of the FSMS to top management.
If we remember that top management maintains the primary responsibility and accountability for the food safety
management system, it is essential that it is kept informed of
the performance of this system.
In accordance with Technical Specification TS 9002:2016, this reporting is
typically carried out as part of the management review process (see ISO 22000:2018 Sub-clause
9.3); One person might be assigned responsibility for coordinating
reporting, with other people taking responsibility for reporting on
specific food safety management system processes.
In this assignment of responsibilities, top management should take into
consideration, that this standard establishes, in paragraph
5.3.2.d) that the food safety
team leader shall be responsible for reporting to top management on the effectiveness
and suitability of the FSMS.
Requirement
No. 95: Top management shall assign the authority for reporting on the performance of the FSMS to top management.
Considering, as mentioned in the previous requirement, that top management maintains primary responsibility and accountability for the food safety
management system, it is essential that it be kept informed of
the performance of this system.
In accordance with Technical Specification TS 9002:2016, this reporting is
typically carried out as part of the management review process (see ISO 22000:2018 Sub-clause
9.3); Authority could be assigned to a
person to coordinate reporting, with other persons with reporting authority on specific processes
of the quality
management system.
In this assignment of authorities, top management should take into consideration
that this standard does not assign any
authority on the food safety team leader, for reporting to
top
management on the effectiveness and suitability of the FSMS just a responsibility.
Requirement
No. 96: Top management shall assign the responsibility for appointing the food safety team.
The food safety team is of great importance
for the “Hazard
analysis and critical control points” (HACCP) to be carried out, for
the integration of the food safety plan, as well as to achieve control of critical points, and therefore, so that
the food
management system achieves an appropriate performance
and the expected
results. This should be a multidisciplinary team, with people with a high
technical level in various fields of knowledge related to food safety, the food chain, processes and products,
the organization and it could include
people from outside the organization, in case it is required to complete the
competencies of this team.
That is why top management should be very careful in
selecting the person, or persons, to whom they will assign the responsibility for choosing the members
of this food safety
team.
Requirement
No. 97: Top management shall assign the authority for appointing the food safety team.
As we have seen in relation with the previous requirement, the food safety team is of great importance
for the “Hazard
analysis and critical control points” (HACCP) to be carried out, for
the integration of the food safety plan, as well as to achieve control of critical points, and therefore, so that
the food
management system achieves an appropriate performance
and achieves the expected
results. This should be a multidisciplinary team, with people with a high
technical level in various fields of knowledge related to food safety, the food chain, processes and products,
the organization, and it could include
people from outside the organization, in case it is required to complete the
competencies of this team.
That is why top management should be very careful in
selecting the person, or persons, to whom they will assign the authority for choosing the members
of this food safety
team.
Requirement No. 98: Top management shall assign the responsibility for appointing the food safety team leader.
Just as the importance of assigning the
responsibility for appointing food safety team members was previously
mentioned, it is also important that top management carefully assign the
responsibility for appointing
the leader of that food safety team. For this, it would be
important to consider a person who has a sufficient knowledge and experience in
relation to hazard
analysis and critical control points, safety food programs,
the products involved in that food safety management system, as well as from the organization itself, and in this case
it is important that it be someone who is part of the organization's staff.
Requirement
No. 99: Top management shall assign the authority for appointing the food safety team leader.
Just as the importance of assigning the
authority for appointing food safety team members was previously
mentioned, it is also important that top management carefully assign the
authority for appointing
the leader of that food safety team. For this, it would be
important to consider a person who has a sufficient knowledge and experience in
relation to hazard
analysis and critical control points, safety food programs,
the products involved in that food safety management system, as well as from the organization itself, and in this case
it is important that it be someone who is part of the organization's staff.
Requirement
No. 100: Top management shall assign the responsibility for designating persons with defined responsibility and authority to initiate action(s).
The ISO 22000: 2018 standard identifies four types
of actions that can be carried out
by the organization:
- Actions taken by the organization to address risks and opportunities (see
6.1);
- Actions to reduce the consequences of an emergency situation (see 8.4.2 b);
- Corrections (see 8.9.2 and 10.1.1 a);
- Corrective actions (see 8.9.3 and 10.1.1 b).
The food safety management system should have the ability
to respond quickly to any emergency situation as to any nonconformity, and that is why top management should assign the
responsibility for designating all
persons with defined responsibility and authority who, after an
identification of an emergency situation as well as of a failure in the FSMS and documentation of the
corresponding nonconformity, may initiate the
necessary actions to reduce the consequences of that emergency situation,
or in its case correct or eliminate the cause of that failure, as well as to prevent
its recurrence.
It is recommended that the same person(s) be assigned
the responsibility and the authority to initiate one
or some types of actions.
Requirement
No. 101: Top management shall assign the authority for designating persons with defined responsibility and authority to initiate action(s).
These two last requirements are closely linked, since although they are
different, because one refers to assigning
responsibility and the other to assigning authority, in order to designate
the people with defined responsibility and authority to initiate action(s).
As we saw with the previous requirement, the ISO 22000: 2018 standard identifies four types
of actions that can be carried out
by the organization:
- Actions taken by the organization to address risks and opportunities
(see 6.1);
- Actions to reduce the consequences of an emergency situation (see 8.4.2 b);
- Corrections (see 8.9.2 and 10.1.1 a);
Corrective actions (see 8.9.3 and 10.1.1 b).
In the same way that we have mentioned it in
relation to other requirements of this section, the assignment
of responsibility and authority to designate the persons
with responsibility and authority to initiate action(s), may be to one or
more persons.
Requirement
No. 102: Top management shall assign the responsibility for designating persons with defined responsibility and authority to document action(s).
This requirement is closely related to No. 100, previously seen, assigning
the responsibility for designating
persons with defined responsibility and authority to document action(s). It is recommended that the
person to whom this responsibility is assigned is the
same person to whom the responsibility mentioned in relation to requirement No. 100 above has been assigned.
The persons designated in order to
accomplish this requirement, with defined responsibility and authority to document action(s) could be the same designated
in relation with that Requirement
No. 100, or they could be different.
Requirement
No. 103: Top management shall assign the authority for designating persons with defined responsibility and authority to
document action(s).
This requirement is closely related to No. 101, previously seen, assigning
the authority for designating
persons with defined responsibility and authority to document action(s). It is recommended that
the person to whom this authority is assigned is the same person to whom the authority mentioned in relation to
requirement No.
101 above has been assigned.
In the same way we mention it, the persons designated in order to accomplish this requirement, with defined responsibility and authority to document action(s), could be the same designated in relation with that Requirement No. 101, or they could be different.
Requirement
No. 104: The food safety team leader shall be responsible for ensuring the FSMS is established.
In this one and the following requirements, this section of ISO 22000: 2018 standard assign directly
these responsibilities to the food safety team leader. In other management standards, these responsibilities are assigned
to top
management.
If you remember, in the Sub-clause 4.4, there is the next requirement: The organization shall establish a food safety management system, including the processes needed and their interactions, in accordance with the requirements of this standard. Thus, according to this requirement, is the food safety team leader who will be responsible for ensuring the FSMS is established.
So, it is
convenient for us to remember that the definition of this term is:
In this way,
based on the meaning of this term and the original wording of both requirements,
we can understand, therefore, that the organization should somehow bring into
existence a food safety management system, in an orderly or determined manner, including the necessary processes and their interactions, in accordance with all requirements of this standard and the food safety
team leader will be responsible for ensuring that this FSMS is existing.
Requirement No. 105: The food safety team leader shall be responsible for ensuring the FSMS is implemented.
In a similar way to what we saw with the
previous requirement, but considering the
term "implement", which if we remember we
can define it as follows:
If we analyze
this
requirement considering this definition, we see that in order for an organization to accomplish this requirement, it should, once it has established its food safety management system, apply the appropriate measures and methods to put
the entire management system into operation. For this, it will be necessary that
all the processes that are part of
this system are operating and are managed appropriately, and the food safety team leader will be responsible for ensuring that this FSMS is operating properly.
Requirement
No. 106: The food safety team leader shall be responsible for ensuring the FSMS is maintained.
Again, in a similar way to what we saw with
the two previous requirements, but considering the
term "maintain", which if we remember we
can define it as follows:
If we analyze
this
requirement considering this definition, we see that in order for an organization to accomplish this requirement, it should, once it has established and implemented its food safety management system, the organization shall keep in an existing state, as of efficiency or validity, a food safety management system, preserving it from failure or decline, including
the processes necessary and their interactions, in accordance with the requirements of this standard and the food safety
team leader will be responsible for ensuring that this FSMS is properly maintained.
Requirement
No. 107: The food safety team leader shall be responsible for ensuring the FSMS is updated.
Again, in a similar way to what we saw with
the three previous requirements, but considering the
term "update", which if we remember we
can define it as follows:
If we analyze
this
requirement considering this definition, we see that in order for an organization to accomplish this requirement, it should, once it has established, implemented and maintained its food safety management system, the organization shall
ensure the application of the
most recent information, by immediate and/or planned activity, of a food safety management system, including the necessary
processes and their interactions, in accordance with the requirements of this document and the food safety team leader will be responsible for ensuring that this FSMS is properly updated.
Requirement
No. 108: The food safety team leader shall be responsible for managing the work of the food safety team.
In order to comply with this requirement, the food safety team leader must have the responsibility of directing the work of
that food safety
team, so that activities such as the following are carried out appropriately:
- Approval of prerequisite programs,
- Collection, maintenance and updating of
preliminary documented information for hazard analysis,
- the establishment, maintenance
and updating of flow charts as documented information for the
products or categories of products within the FSMS,
- On-site confirmation of flow charts,
- Description of the processes and the process
environment,
- carry out the hazard analysis,
- Validation that the selected control
measures, or their combinations, are capable of achieving the expected
control of significant safety hazards,
- Analysis of the results of verification activities, and
- Evaluate the FSMS at planned intervals for
possible updating.
Requirement
No. 109: The food safety team leader shall be responsible for organizing the work of the food safety team.
In order to comply with this requirement, the food safety team leader should have the responsibility of organizing the work
of that food safety
team, so that activities such as the following are carried out appropriately.
Through this responsibility, the food safety team leader should be in charge of structuring the
essential relationships among the food safety team members, tasks, and other
activities. This should be done in a way that the organization's resources are integrated
and are coordinated to accomplish the objectives efficiently and effectively.
Requirement
No. 110: The food safety team leader shall be responsible for ensuring relevant training for the food safety team (see 7.2).
In order to comply with this requirement, the food safety team leader should have the responsibility of ensuring that the food safety
team has a
combination of multi-disciplinary knowledge and experience in developing and
implementing the FSMS (including, but not limited to, the organization’s products, processes, equipment and food safety hazards within the scope of the FSMS), and where
applicable, take actions to acquire
the necessary competence, and
evaluate the effectiveness of the actions taken.
Applicable actions can include, for example, the provision of training to, or the mentoring of currently employed persons.
Requirement
No. 111: The food safety team leader shall be responsible for ensuring relevant competencies for the food safety team (see 7.2).
In order to comply with this requirement, the food safety team leader should have the responsibility of ensuring that the food safety
team members have a
combination of multi-disciplinary knowledge and experience in developing and
implementing the FSMS (including, but not limited to, the organization’s products, processes, equipment and food safety hazards within the scope of the FSMS). This food safety team leader should:
- determine the necessary competence of the food safety team members, including external
providers, doing work under its control that affects its food safety performance and effectiveness
of the FSMS;
- ensure that these food safety team members are competent on the
basis of appropriate education, training and/or experience;
- ensure that the food safety
team members have a combination of multi-disciplinary knowledge and experience in developing
and implementing the FSMS (including, but not limited to, the organization’s products, processes,
equipment and food safety
hazards within the scope of the FSMS); and
. retain appropriate documented information
as evidence of competence.
Requirement
No. 112: The food safety team leader shall be responsible for reporting to top management on the effectiveness of the FSMS.
In order to comply with this requirement, the food safety team leader should have the responsibility for keeping informed of
the performance of the FSMS, as well as the comparison of the results achieved against the food safety objectives established by the organization, and for reporting to top management on the effectiveness of the FSMS.
Requirement
No. 113: The food safety team leader shall be responsible for reporting to top management on the suitability of the FSMS.
In order to comply with this requirement, the food safety team leader should have the responsibility for keeping informed of
the performance of the FSMS, as well as the comparison of the results achieved against the food safety objectives established by the organization, and for reporting to top management, in addition to the effectiveness of the FSMS, as we saw it in the previous requirement, the quality of being right or appropriate this system for its
particular purpose.
Requirement
No. 114: All persons shall have the responsibility to report problem(s) with regards to the FSMS to identified person(s).
To meet this requirement, the organization´s top management should make all staff
aware of the responsibility assigned to them by
the standard for reporting problems
with respect to the FSMS to the identified persons who have been assigned responsibility for documenting nonconformities, as well as those to
document and initiate action(s).
In the next entry we will begin the
analysis of requirements derived from Clause 6 - Planning, So for this we will be
starting with requirements derived from Sub-clause
6.1 - Actions to address risks and opportunities, of this ISO 22000:2018 Standard.
Your doubts or comments that you want to
upload to this blog about the analysis
presented will be always welcome.
Author:
Ernesto Palomares Hilton
Comments
Post a Comment
Nombre:
País:
Comentarios: