ISO 22000:2018/FSSC 22000 Decision Tree Model

A Trickledown Approach

The blog earlier published ISO 22000:2018 Decision Tree Model, when there were not any single model were available on the internet, then it was expecting comments from the public, however, unfortunately it was visited vast majority, but very few were to be comment or ask questions. The blog has two decision tree models published to date for ISO 22000:2005 and another for ISO 22000:2018, and both have very high rates of visits every day, because it might have  been a tough question for users to find reliable information. On the other hand, with the limited comments, it is almost impossible for us to give you a better information, thus I encourage readers to comments on the facts and ask valuable questions that it will be useful to others too.

 Being said that, it was sometime before I realized a minor mistake that was in my previous model which I eventually corrected immediately, but I didn’t relieved my embarrassment until I could come out of a solution after months of brooding and working on it. Thus, I hope this new model will answer lots of ambiguity in the minds of the users and it will give a more comprehensive approach to the requirements of the ISO 22000:2018 selection and categorization of control measures. The model given below is a hybrid development extending my former ISO 22000:2018 decision model and descriptions given in the ISO/ITC book “ISO 22000:2005 Food safety Management Systems, An easy-to-use check list for small business – Are you ready?” as well as codex decision tree and new requirements added in the ISO 22000:2018 version. However, it is not perfect as use to be and application on your work is completely voluntary, but if you need any clarification; you are always welcome to write down a comment or send a mail. The site is always happy to help anyone who is in need.

Now let’s get to the major facts laid out in the standard where following information is directly extracted from the standard to give a clear picture of what we are up to.

        

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 a n 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)

Mandatory Definitions

However, it is mandatory to refer following definitions in order to clearly understand the complex nature of the requirements for a practical applications of the above requirements in a decision making process while segregating CCPs, OPRPs and PRPs. Hence, it is a general norm that, ISO 22000 standard is promoting more intelligence based decision making instead of logical decision making through a standard decision tree. In contrast, most of the users prefer logical sequence even though they apply intelligence based answers for the requirements. In fact, it is pretty normal situation, because users of the standards are usually supposed to be looking at standard recognized expert models rather than wasting time for developing something extravagant. Thus, it is a useful objective of developing something like a comprehensive decision tree that can apply standard framer’s intelligence based requirements in the ISO 22000:2018 to demonstrate logical sequence such as CODEX decision tree, where you need to consider above 8.5.2.4 with the following definitions to understand the complete picture.       

Action criterion (3.2)

Measurable or observable specification for the monitoring of an OPRP

Control Measure (3.8)

Action or activity that is essential to prevent a significant food safety hazard or reduce it to an acceptable level  

Correction (3.9)

Action to eliminate a detected nonconformity

Critical control point - CCP (3.11)

step in the process (3.36) at which control measure(s) is (are) applied to prevent or reduce a significant food safety hazard to an acceptable level, and defined critical limit(s) and measurement enables the application of corrections

Critical limit (3.12)

Measurable value which separates acceptability from unacceptability

Food safety hazard (3.22)

Biological, chemical or physical agent in food with the potential to cause an adverse health effect

Measurement (3.27)

Process to determine a value

Monitoring (3.28)

Determining the status of a system, a process or an activity

Operational prerequisite programme - OPRP (3.31)

Control measure or combination of control measures applied to prevent or reduce a significant food safety hazard to an acceptable level, and where action criterion and measurement or observation enable effective control of the process and/or product

Prerequisite programme - PRP (3.35)

Basic conditions and activities that are necessary within the organization and throughout the food chain to maintain food safety

Significant food safety hazard (3.40)

Food safety hazard, identified through the hazard assessment, which needs to be controlled by control measures

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

By considering above all information you can distinguish CCP and OPRP with following specific differences.

CCP                                                    OPRP

Step in the process                          Step in the process or not in the process                      

Single control measure                   Control measure or combination of CMs

Critical limits                                    Action criteria or control limits

Measurement                                    Measurement or observation

Enable correction                             Enable control of product or process

Once you have a clear idea of what you need to separate through your process, it is becomes easy to deal with 8.5.2.4 selection and categorization of control measure(s), the most critical and most ambiguous explanation of the standard.  However, clause 8.5.2.4.1 (a, b:1-4) and 8.5.2.4.2 (a, b, c) share eight basic requirements which further needs to be evaluated based on above differentiation in mind. In fact, given 10 questions in the ISO 22000:2018/FSSC 22000 decision tree and in CCP/OPRP Decision Table were developed to differentiate above requirements in a sequential order with familiar terminologies used in available HACCP decision tree questions as the process is basically a more comprehensive extension of CODEX HACCP process.  

Once you look at the given ISO 22000:2018 and FSSC 22000 compatible decision tree, it is obvious that question Q2, Q3 and Q4 are exactly the same questions in the codex decision tree in the same positioning while question Q5 has slightly deviated and extended from the question Q1 of the codex diagram. However, the given model is not as same as its predecessor, because it has very limited window of eliminating a process step, if it is identified as a prone to functional failures or has a significant food safety hazard. The only possibility of slipping off of any step/process/product from the process of evaluation through questions Q3 or Q4 (the basic codex decision tree questions). However, those “not a CCP/OPRP” steps are still needs to identify with relevant PRPs to monitor its environment. If a step is identified as not prone to failures or no significant food safety hazard at the beginning, the step still needs to be managed with relevant PRPs as they are usually managed.

ISO 22000:2018/FSSC 22000 Decision Tree Model - A Trickledown Approach

Thus, a step, process or a product reaches up to the question Q5 means that, it is supposed to be repeatedly going in comprehensive cycles of loops before it is categorized in to a CCP or an OPRP in most occasions. As it developed, it is more obvious that there will be very few CCPs while many OPRPs in a process. In fact, all the identified CCPs and OPRPs are required to be addressed in the Hazard Control Plan which is another term to a preventive control plan.  This part of the standard is more aligned with FSMA requirements as it was in consideration at the time of its revision process. Hence, if an organization trying to operate an ISO/FSSC 22000 FSMS with the status of a FDA registered facility complying to FSMA requirements or FSVP,  it is actually very easily compatible with each other as both documents are preventive control plans that requiring almost same requirements while documenting it. As such, the framers of the standard has smoothly aligned its requirements with FDA regulations promoting more effective synchronization.  

Therefore, the given decision tree “ISO 22000:2018/FSSC 22000 Decision Tree Model - A Trickledown Approach” basically designed to trickle down the CCPs while making sure that almost any of a kill-step or a critical control point is a specifically designed process step for its objectives and open for continuous improvements. Further, it has been looped inside logical sequence to provide any rejection to flow-back to the top of the decision tree, and move down through the process until it is accurately assigned according to the standard requirements.  

In addition, the questions used in the decision tree can be converted to a CCP/OPRP Decision Table, which eventually becomes the part of Hazard Control Plan. The following example provide clear dynamics of the application based on the previous article “ISO 22000:2018 Decision Tree”. The CCP/OPRP table can be used as an alternative to decision tree or both can be used in a combination with more clarity and transparency for decision making process.     

     

ISO 22000:2018 Decision Table