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Sunday, August 12, 2018

ISO 22000:2018 Decision Tree

ISO 22000:2018 Determination of CCPs and OPRPs

If you search the web these days, you will come across with hundreds of articles explaining what’s new in
the ISO 22000 standard and many explanations regards to adaptation of new requirements. Hence, it was
obvious to find out ISO 22000:2018 new decision tree or a decision table of logical sequence to apply CCP
and OPRP segregation. Unfortunately, if you search the web, you still find only the old explanations of
such decision trees and if you further try to find out them as images of such logical sequence surprisingly
most of them are published in ISO 22000 resource center in various articles. Thus, I decided to publish a
new decision tree for ISO 22000:2018 version which I recently developed for my ISO 22000:2018 Generic
Model published on amazon kindle. As to the last article, it briefly discussed what’s new in the standard
and how it is going to affect your existing systems as well as new systems that are to be waiting for the
development. Since many articles talk about the various sections of the standard, it is not very important
at this point to comment on them, but there will be several new articles explaining the changes in the
standard as well as expert views on the subject.

The irony of the ISO 22000:2018 standard revision is that, the standard has kept segregation of CCP and
OPRP as mystery yet or most ambiguous puzzle yet as it was kept for last 13 years. Anyway, they have
cleaned up the idea somewhat and some of the previous words were taken off while adding few more, but
they have failed to simplify it, where it is our speculation that, even the expert panel may not have
fundamental agreement or complete understanding of how they are exactly segregate CCPs and OPRPs.
Thus, they have kept adding more and more parameters to the CODEX decision tree model but they
haven’t clear it with a proper generic model such as a decision tree or a decision table or any other method
while keeping the ball in manufacturer’s courtyard. As to the food safety, segregation of CCPs and OPRPs
are the most important part of the operation, but after four years of discussions and meetings, it is look like
the expert panel has not found any suitable solution to it rather than complexing it for average man to
understand.

The HACCP plan has been changed to Hazard

control plan and HACCP word is officially out from the standard, but it is obvious that people will not
remove HACCP decision tree officially from the systems unless there will be an official decision tree.
Because decision trees are very easy to distinguish and understand for an average intelligent person and
standard also requesting a logical sequence for decision making process. As a skeptic, I have kept my eye
open for may be last 10 years at least to the internet, ISO 22000 books, updated ISO 22004, online forums,
sessions, conferences and I have asked hundreds of auditors, many trainers and consultants, but
unfortunately no body was ever able to give me a completely satisfying answer or an easy solution that
may be very important to the users. Because it is the most ambiguous area of the standard to any average
user yet. If you consider HACCP or CODEX decision trees, whether it is completed or not, they have given
a very simple and easily understandable answer with a diagram where most of the people in food industry
actually use it rather than ISO 22000 or any other, because they are not clearly understandable to the
average user and it keeps you doubting to yourself if you are right or wrong on your decision making
process, if yourself develop a one, instead of using already accepted one.
 Accordingly, we were expecting the technical
committee to sort it out at least by this revision, because most of the private standards are also use these
principles as their base, instead of developing their own. However, technical committee have not yet
fulfilled our hopes where most of the users still will stick to the CODEX, the most clearly explained
segregation. But we all know it is not enough since there is a clear cut line between PRPs and CCPs, but
some of the control points are really don’t fall into any of these categories and everybody trying to define
it and still no clear agreement, because there is no clarity. Henceforth, many people many consider many
CCPs than they should consider or less than they should consider, which actually depend on various other
factors such as auditors, buyers, company’s budget for quality assurance or their real understanding. Here
is an image from the internet, which was found in Safe Food 360˚, published in July 30, 2014 by George
Howlett, one of my favorite writers of food safety in Europe, he named it as funny decision tree, which is
actually the case in many organizations around the world. As to his writing I have taken one another image
below to show that how we need to simplify the decision making process, rather than complexing it for
practitioners.

Many times, in various occasions when I asked experts, they provided some answers, but at the same time
they push the ball back to my court asking me, why don’t you develop a one. Most of the time, I actually
had a one developed, but as already explained I had the same doubts about it, anyway later-on when many
people asking me about the complexity of decision making part of the standard, it was published on this
blog and it has reached the top of the most viewed articles list if you look at your left, because as already
explained there are lots of ambiguity in the area of decision making in ISO 22000. However, even after
publishing it, I was not completely satisfied with what was developed and which was audited by several
auditors. However, I was not quite convinced of my own decision tree or the table, where do you think that
an average person will be okay with what he has done?
 Few weeks back, while I was developing the “ISO 22000:2018 Generic Model” which is already on amazon
as a Paperback and Kindle versions, I did several of them because I’m not convinced once they were
completed that they are fully complying with what standard requests us to comply with. The explanations
given in the standard are vague and generic (look at the below italic text), which is the usual nature of
standards, but areas like segregation of CCPs and OPRPs should have to have much more comprehensive
explanations (like a diagram or specific method of evaluation) rather than few lines given in the standard.
Because it specifically asking you for a logical sequence and documented information of how you arrived
at your decision, but if an average user can not exactly distinguish the standard, they will not apply the
right sequence for it.

Here is what ISO 22000:2018 explains about selection and categorization of control measures.

8.5.2.4 Selection and categorization of control measure(s)

8.5.2.4.1
Based on the hazard assessment, the organization shall select an appropriate control measure or combination of control
measures that will be capable of preventing or reducing the identified significant food safety hazards to defined
acceptable levels.
The organization shall categorize the selected identified control measure(s) to be managed as OPRP(s) (3.31) or at
CCPs (3.11).

The categorization shall be carried out using a systematic approach. For each of the control measures selected there
shall be an assessment of the following:
a) The likelihood of failure of its functioning;
b) The severity of the consequence in the case of failure of its functioning; this assessment shall include:
1) The effect on identified significant food safety hazards;
2) The location in relation to other control measure(s);
3) Whether it is specifically established and applied to reduce the hazards to an acceptable level;
4) Whether it is a single measure or is part of combination of control measure(s).

8.5.2.4.2
In addition, for each control measure, the systematic approach shall include an assessment of the feasibility of:
a) Establishing measurable critical limits and/or measurable/observable action criteria;
b) Monitoring to detect any failure to remain within critical limit and/or measurable/observable action criteria;
c) Applying timely corrections in case of failure.

The decision-making process and results of the selection and categorization of the control measures shall be maintained
as documented information.

External requirements (e.g. customer requirements) that can impact the choice and the strictness of the control
measures shall also be maintained as documented information.

(Source: ISO 22000:2018, Food safety management systems – Requirements for any organization in the food
chain)

Hence, I decided to publish what I have done myself which not may be the exactly what technical
committee expected, but it will at least ease the burden of many users, who will love to use a decision tree
logic than a table, until ISO 22000 expert panel or WTC book will give us a possible solution later. Thus, it
is an alternative only, and the responsibility is vested on users to decide themselves before use it, because
there will be lot of models followed by due to the lack of standard decision tree or a table to decide the fate
of CCP or OPRP. Until such a standard explanation is officially exists, you can try my decision tree model
for ISO 22000:2018 and the decision table with some logical sequence, which may not be the one exactly on
experts mind.
 ISO 22000:2018 Decision Tree
The following assumptions were used while developing the ISO 22000:2018 decision tree.
1. If a control measure do not have a measurable critical limit, it cannot be considered as a CCP according
to the general understanding in the industry.

2. If there is no possibility to monitor measurable critical limits or observable action criteria, such control
measures cannot be used as a CCP or a OPRP which needs to be modified to control or monitor.

3. The word “TIMELY” has been considered as “OPPORTUNE”, which generally means that a product that
will not be potentially harmful for the general public if the control measure is failed and still there is an
opportunity to do the corrections without effectively harming the product. Hence, it shall not be considered
as a CCP.
4. The Q5, can be considered as the segregation point for OPRPs and CCPs, because most of the “part of
combination of control measures are usually categorized under OPRPs. But the standard still specifically
instruct you to get a logical sequence and answers for all other 3 feasibility criteria mentioned before finalize
your decision.

ISO 22000:2018 Decision Table

Posted by Vindika Lokunarangodage at 12:59 PM

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1 comment:
1.
gonzalog3September 27, 2018 at 12:51 PM

thanks for you support

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