4 replies to this topic

[mhosn]

I can't understand the meaning of the question 4 in decision tree in fssc guideline :

 

Question 4: Is there any failure of the control measure with a high risk (likelihood x severity) for the safety of the product? (8.5.2.4.1) Include the following: - The effect on the hazard. - Control measure specifically applied to reduce to acceptable level? - Any subsequent control measures? - Single control measure or combination?

 

 

I need example to determine oprp or ccp

 

 

Regards,

[Scampi]

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).

[mhosn]

I need an example one if the answer is no to be prp , and other example with yes answer to be ccp.

Because i didn't understand how can I answer the question 4 in decision tree

[Tony-C]

Hi mhosn,

 

I’m posting the FSSC 22000 Guidance document: ISO 22000 Interpretation Decision Tree Questions Image so that everyone is clear what you are referring to when you are asking about Question 4.

 

 FSSC Guidance ISO 22000 Interpretation Decision Tree Q4.png   887.02KB   1 downloads

 

Not sure I like this decision tree, it seems to add a bit more confusion by trying to simplify the assessment process. A No to question 4 means that failure of the control measure does not have a high risk of unsafe product. This means to me that the control measure is more likely PRP or if needed there should be a redesign of the control measure, process or product. Maybe if the control measure is considered effective in combination with another control measure then it may well be considered an OPRP.

 

FSSC 22000 Guidance document: ISO 22000 Interpretation offers the following:

 

In clause 8.5.2.4, ISO 22000 includes both the assessment of likelihood x severity of failure and of the feasibility of detection and correction. ISO 22000:2018 is not explicit about how these assessments relate to the categorization of OPRPs and CCPs. Table 2 displays a possible interpretation for the outcomes of the assessment. Note that the categorization in clause 8.5.2.4 does not include PRPs: PRPs are added to table 2 to complete the overview. The impact of failure of PRPs is low, basically because they do not control significant hazards.

 

Table 2: PRPs, OPRPs and CCPs as a product of the likelihood x severity of failure and the feasibility for detection and correction of this failure.

 

 FSSC Guidance ISO 22000 Interpretation PRP OPRP CCP Table.png   278.24KB   1 downloads

 

The assessment of the likelihood x severity of failure in ISO 22000 is the basic to the understanding of OPRPs: a control measure, managed as an OPRP controls a significant hazard but failure of on OPRP does not necessarily lead to unsafe product. This is reflected in clause 8.5.2.4.1. In this clause control measures can be categorized as to be managed as OPRPs when a) the likelihood of failure is low and/or b) the severity of the consequence of failure is low.

 

Since failure of an OPRP does not necessarily lead to unsafe product, it is not necessary to detect and correct each and every single case of failure. To express this, the criteria for the application of OPRPs are referred to as action criteria. Failure to meet an action criterion requires corrective actions towards the process. Correction towards the product is decided on case by case after assessment of causes and consequences of failure. For CCPs, where the likelihood x severity is high, the criteria for the application of the control measure are referred to as critical limits.

 

My view is the guidance is somewhat simplified for ease of explanation as you also need to consider Question 4 in conjunction with clause 8.5.2.4.2 requirements/Question 5.

 

An example as you ask that would be a No to Question for would be filtration of a raw material when there is a control measure for finished product that removes the hazard such as metal detection or X-ray. In this case I want to filter my raw materials to remove foreign bodies but the control measure is early in the process. My subsequent control measure (a likely CCP but if not an OPRP) is at the end of the process and will pick up any foreign bodies that may have contaminated the product during processing as well as those in the original raw material.

 

My question would be, is raw material filtration an OPRP or a PRP? Probably a PRP.

 

Kind regards,

 

Tony

[Charles.C]

Hi Tony,

 

This decision tree has been additionally discussed in previous threads with (in my case) mostly negative opinions.

IMO, analogously to the intro in your previous Post, it is an attempt to give a veneer of "scientific" precision to what is (and always has been for iso22000) often a subjective Procedure and final choice of CCP/OPRP.

I note that the FSSC Guideline includes a comment that the presentation is only one approach and alternative methods can be acceptably used. Personally I would utilize the latter option for which some suggestions have been posted elsewhere on this Forum.