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Saturday, June 4, 2016

ISO 22000:2005 Decision Tree Logic and a Possible

Decision Tree Model
The problems with ISO 22000 Decision Tree

Considering the ISO 22000:2005 decision tree logic, it does not fairly explained in any official or private
discussions published over online or printed which is one of the very important areas of designing a system
where ISO 22000 is clearly deviated from Codex HACCP. But unfortunately working groups of standard
developers or system writers never concentrate on this specific area and various people has designed
different initiatives but none has been shown promising or addressing the exact key points defined by the
standard itself. On the other hand, when it comes to certification audits, auditors question the decision
making logic but they never provide an accurate answer to the question of what is the recognized or
recommended model. Thus lots of food safety teams adapted to digitally available models, but they seems
to be lacking the adherence to the standard or more complex and too technical. Thus it is mandatory to
address this area properly under the coming review with complete solutions to the lagging part of decision
making process.
 According to the ISO 22000:2005, following description is given under 7.4.3 Hazard Assessment; A hazard
assessment shall be conducted to determine, for each food safety hazard identified (see 7.4.2) whether its
elimination or reduction to acceptable levels is essential to the production of a safe food, and whether its
control needed to enable the defined acceptable levels to be met.

Each food safety hazard shall be evaluated

according to the possible severity of adverse health effects and the likelihood of their occurrence. The
methodology used shall be described, and the results of the food safety hazard assessment shall be
recorded. As to the above requirements, the hazard identification, analysis, and classification of defined
acceptable levels can be easily carried out with the explained model under the book published by the ISO
and WTO, “ISO 22000 Food Safety Management Systems: An easy-to-use checklist for small business, Are
you ready?” or using the HACCP seven principles or both. This is further explained in the standard under
the 7.4.4 Selection and assessment of control measures as follows: based on the hazard assessment of
7.4.3, an appropriate combination of control measures shall be selected which is capable of preventing,
eliminating or reducing these food safety hazards to defined acceptable levels. In this selection, each of the
control measures as described in 7.3.5.2 shall be reviewed with respect to its effectiveness against the
identified food safety hazards.

The control measures selected shall be categorized as to whether they need to be managed through
operational PRP(s) or by the HACCP plan.

The selection and categorization shall be carried out using a logical approach that includes assessments
with regards to the following:

a) Its effect on identified food safety hazards relative to the strictness applied
b) Its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable immediate
corrections)
c) Its place within the system relative to other control measures
d) The likelihood of failure in the functioning of a control measure or significant processing variability
e) The severity of the consequence(s) in the case of failure in its functioning
f) Whether the control measure is specifically established and applied to eliminate or significantly reduce the
level of hazard(s)
g) Synergetic effects (i.e. interaction that occurs between two or more measures resulting in their combined
effect being higher than the sum of their individual effects.)

Control measures are categorized as belonging to the HACCP plan shall be implemented in accordance
with 7.6. Other control measures shall be implemented as operational PRPs according to 7.5.

The methodology and parameters used for this categorization shall be described in documents, and the
results of the assessment shall be recorded. The entire description was given in the ISO 22000:2005 standard,
but it does not explains any specific methods to decide on CCPs or OPRPs and PRPs where standard has
given the opportunity of selecting a suitable methodology by the food safety team to segregate control
measures.

In addition to that, following description was given in the book “ISO 22000 Food Safety Management
Systems: An easy-to-use checklist for small business, Are you ready?” A logical process must be used to
assess and sort the control measures into the three groups (PRPs, Operational PRPs and CCPs). This process
should take into account a number of factors such as:
Its effect on the hazard relative to the strictness of its application;
The feasibility of monitoring it in a timely manner;
The impact of its failure;
Its role and capacity to eliminate, or significantly reduce, the level of hazard;
Its interaction or synergy with other control measures.

Decision trees may assist you in making these selections. The Codex Decision Tree was designed to identify
CCPs which is one choice. On the other hand, the ISO 22000 approach, which will aid your food safety team
in sorting control measures into the three groups.

More than one control measure is often required to control (a) specific food safety hazard(s)and more than
one food safety hazard may be controlled by the same control measure (but not necessarily to the same
extent). It is therefore advisable first to select suitable combinations of control measures for each of the
hazards identified, followed by a consequential establishment of the whole range of control measures
required to control all of them.

The information required to assess the effect of a control measure includes the following.
1. How the food safety hazards are affected by the control measure (i.e. reduction,
controlling increases, and/or controlling the frequency of occurrence); these could be
expressed as performance criteria.
2. To what extent the levels of food safety hazards are affected (qualitatively, semi-
quantitatively or quantitatively). Very often the effect depends upon the rigorousness of the
control measure (e.g. temperature, time, concentration, frequency). In carrying out the
assessment, it may be useful to obtain data on the intensity-effect relationships.
3. The step or location, where the control measure is intended to be applied. Some control
measures are more effective if applied after other control measures (e.g. after control measures
that stress microorganisms)
4. Operational variables, including their operational uncertainty (e.g. fluctuation and/or
probability of operational failure).
5. The practical operational range of intensity.

The book has given an extension to what standard defined in 7.4.4, but it has not clearly provided a way-
out to the question “how we segregate CCP, OPRP and PRP based on ISO 22000 7.4.4 requirements.
Additionally, the book has provided following images on both Codex and ISO 22000 decision tree logics as
examples for helping the food safety teams in selection of CCP, OPRP and PRP.
ISO Official Decision Tree Codex Decision Tree

However, ISO 22000 had not given any exact logical sequences like in the HACCP/Codex to decide which
category is most suitable. There are no OPRP selections in the HACCP method where there is no much
complexity over it, but when it comes to auditing, most of the auditors are questioning food safety team or
food safety team leader; “what is your selection method and also how you arrive at the given decision?”
Considering explanations, the official standard as well as their official book, there is no proper technical
explanation to it. Thus this part of the standard is very weak when it compared with Codex explanation on
decision tree logic, and ISO 22000 has tried to depend on it, but Codex decision tree cannot be used as it is
due to the requirements defined in 7.4.4 of the standard. Furthermore, any of the existing publications or
books does not clearly define the decision tree or logic to selection of CCP, OPRP and PRP according to the
ISO 22000 explanation. If you consider ProCert decision tree for an example as given in the image, it is one
of the possible answers easily find in internet, but it has no exact logical order even though it has certain
capabilities of solving the problem.

ProCert Decision Tree

Nonetheless, it does not give you a proper way of understanding the requirements black and white when
you record in a decision table. There are many other explanations available in the net, but none of them are
user-friendly decision making tools. Thus following decision tree was designed after considering most of
the possible answers as well as it defines based on the explanations given in the ISO 22000:2005 7.4.4, but
not in the same logical sequence.
 ISO 22000 Decision Tree – A possible Alternative

The requirements were used in a logical order to improve the understanding as well as to use it in a 9
columned table to get yes or no answers which is more familiar model used in HACCP decision tree. The
given decision tree also may have many limitations which has to be identified with the use which may not
be comprehensive and it has to be reviewed by industry experts before it fully pledged. However, it
provides a possible answer to the problem like ProCert Decision Tree did and modifications may be
possible according to the industry requirements before recognition as a possible solution.

HACCP Plan – CCP/OPRP Decision Table – A possible alternative

Please download the reference table for more detailed understanding, which explains possible way of
using 9 column table with 6 questions in the decision logic to be answered by the food safety team while
preparing ISO 22000:2005 system for certification. The given example is for orthodox black tea
manufacturing process which may not be a comprehensive expanation.

This article may be controversial and I request your comments since ISO 22000:2005 is under review and
industry deserves better explanations and methods to implement systems rather than adhering to technical
jargons which is not understandable for average person working in the food industry. If you need any
further explanation or if you want to rectify any technical errors in this decision tree model, you are warmly
welcome.
Posted by Vindika Lokunarangodage at 8:41 AM
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