With this post I conclude the analysis of the so-called “context” of the ISO 22000: 2018
standard, analysing the missing introductory and complementary elements of this
standard.
Continuing with the clause of Introduction to the standard, subsection 0.3.3 Risk-based thinking is presented in a relatively more complex way, which is why it also contains three subsections:
In subsection
0.3.3.1 General, the
standard indicates that risk-based thinking is essential to achieve an
effective FSMS. In this document, risk-based thinking is addressed at two
levels, organizational and operational, which is consistent with the
process-based approach described in subsection 0.3.2. Plan-Do-Check-Act Cycle (PVHA).
In subsection
0.3.3.2 Organization risk management, the standard indicates that risk is the effect of uncertainty and any
of the possible uncertainties can have positive or negative effects. In the
context of the organization's risk management, a positive deviation arising
from a risk can provide an opportunity, but not all positive effects of risk
result in opportunities.
To comply
with the requirements of this document, an organization plans and implements
actions to address the organization's risks. Addressing risks lays the
foundation for increasing the effectiveness of the food safety management
system, achieving better results and preventing negative effects.
In subsection
0.3.3.3 Hazard Analysis - Operational Processes states that the concept of risk-based thinking,
which arises from HACCP principles at the operational level, is implicit in
this document.
Subsequent
steps in HACCP can be considered as the necessary measures to prevent or reduce
hazards to acceptable levels to ensure that the food is safe at the time of
consumption.
Decisions
made in applying HACCP should be science-based, bias-free and documented.
Documentation should include all key assumptions in the decision-making
process.
One of the most important points in order to understand the requirements of this standard, is to differentiate two terms that generally may cause confusion, which are the following: hazard and risk.
The same standard mentions that a food safety hazard is a biological, chemical, or physical agent in the food, including allergens and radiological substances, with the potential to cause an adverse effect on health. However, the same document clarifies that the term “hazard” should not be confused with the term “risk”, which, in the context of food safety, means a function of the probability of an adverse effect on the health (e.g., becoming diseased) and the severity of that effect (e.g., death, hospitalization) when exposed to a specified hazard.
Therefore,
the concept of “Hazard Analysis and Critical Control Points (HACCP)” refers to food
contamination hazards and not the risks related to those hazards should be made
clear.
Similarly, it
is important to understand the concept of "risk-based thinking" in
subsection 0.3.3 of the standard, it refers generally to the risks related to an FSMS.
0.4 Relationship with other management system
standards
This document
has been developed within the ISO High Level Structure (HLS). The goal of the
HLS is to improve the alignment between ISO management system standards. This
document enables an organization to use the process approach, coupled with the
PHVA cycle and risk-based thinking, to align or integrate the FSMS approach
with the requirements of other management systems and supporting standards.
This document
is the central principle and frame of reference for the FSMS and establishes
the specific requirements of the FSMS for the organizations throughout the food
chain. Other guides related to food safety, specifications and / or specific
requirements of the food sectors can be used in conjunction with this
framework.
In addition,
ISO has developed a family of associated documents, which includes documents
for:
— prerequisite programs (ISO / TS 22002
series) for specific sectors of the food
chain;
— requirements for auditing and certification
bodies;
— traceability.
ISO also
provides guidance documents for organizations on how to implement this document
and related standards.
1 Scope
This first
clause of the ISO 22000: 2018 standard, which is also informative, indicates
that this document specifies the requirements for a food safety management
system (FSMS) to be able to allow an organization that is directly or
indirectly involved in the food chain:
All requirements in this document are generic and are intended to apply to all organizations in the food chain, regardless of size or complexity. Organizations that are directly or indirectly involved include, but are not limited to, food producers, animal food producers, plant and wildlife harvesters, farmers, ingredient producers, food manufacturers, retailers, and organizations that provide food services, catering services, cleaning and disinfection services, transportation, storage and distribution services, equipment suppliers, cleaning and disinfectants, packaging materials and other food contact materials.
This document
enables any organization, including small and / or less developed (for example,
a small farm, a small packer-distributor, a small retailer, or a food service
sale) to implement externally developed elements in its FSMS.
Internal and
/ or external resources can be used to meet the requirements of this document.
Clause. 2 Normative
references, indicates that no normative references are
presented in this document.
Regarding
Clause 3. Terms and definitions, 45 terms
are identified and their corresponding definitions are established.
Regarding the
Bibliography Clause, not numbered also, which is complementary information to the standard, the following
documents are listed:
[1] ISO 9000: 2015, Quality management systems - Fundamentals and
vocabulary
[2] ISO 9001: 2015, Quality management systems - Requirements
[3] ISO 19011, Guidelines for the audit of management systems
[4] ISO / TS 22002 (all parts), Prerequisite programs on food safety
[5] ISO / TS 22003, Food safety management systems - Requirements for
bodies providing audit and certification of food safety management systems
[6] ISO 22005, Traceability in the food chain for human and animal
nutrition - General principles and basic requirements for the design and
implementation of the system
[7] ISO Guide 73: 2009, Risk management - Vocabulary
[8] CAC / GL 60-2006, Principles for Traceability / Product Tracing as a
Tool Within a Food Inspection and Certification System
[9] CAC / GL 81-2013, Guidance for governments on prioritizing hazards
in feed
[10] CAC / RCP 1-1969, General Principles of Food Hygiene
[11] Joint FAO / WHO Food Standards Program. Codex Alimentarius
Commission: Procedural Manual. Twenty-fifth edition, 2016
[12] Codex Alimentarius. Available from:
http://www.fao.org/fao-who-codexalimentarius/en/
Likewise, as
supplementary information, two Annexes are presented at the end of the text of
the standard:
- Annex A contains the
cross references between the HACCP of the Codex Alimentarius Commission and
this standard, and
- Annex B containing
cross references between this standard and the ISO 22000: 2005 edition.
Author:
Ernesto Palomares Hilton
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