4 replies to this topic

[Evez]

In the Question for this Decision Tree, there are 4 sub-items.
it there a need that all answers will be "No" to consider the step as OPRP?

 

 

Q4. Is there any failure of the control measure with a high risk (likelihood x severity) for the safety of the product?
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?

If NO, Categorize the control measure as an OPRP.

If YES, move to Q5.

[Tony-C]

Hi Evelyn,

 

Welcome to the IFSQN forums

 

This question 4 is related to INTERNATIONAL ISO STANDARD 22000 2018 Food safety management systems — Requirements for any organization in the food chain – Section 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) (see 3.30) or at CCPs (see 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).

 

It would appear that the Question 4 in the guidance is not a clear Yes/No answer to all the bullet points and you should take a view on the likelihood of it being an OPRP or CCP based on the ISO 22000 8.5.2.4.1 criteria.

 

For example, last control measure controlling a hazard in the process is more likely to be a CCP. Also, whether it is a single measure or is part of combination of control measure(s), is not really a Yes/No answer in my view.

 

I would reword this question: Is the severity of the consequence in the case of failure of its functioning likely to mean this is a CCP?

No – OPRP

Yes – Go to question 5

 

The guidance document does state: The appendix to this document presents a decision tree (spread over two pages) that can be used to conduct a hazard analysis within the framework of ISO 22000. Potential users should be aware that this decision tree is a result of an interpretation and that other tools can be used.

 

Kind regards,

Tony

[Charles.C]

In the Question for this Decision Tree, there are 4 sub-items.
it there a need that all answers will be "No" to consider the step as OPRP?

 

 

Q4. Is there any failure of the control measure with a high risk (likelihood x severity) for the safety of the product?
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?

If NO, Categorize the control measure as an OPRP.

If YES, move to Q5.

Hi Evelyn,

 

The fss22000 Guidance document  is undoubtedly well-intentioned but, particularly on the page you refer, IMO tends to confuse rather than assist. Tony's final quote is a key one, the choice of an appropriate decision tree/methodology involves interpretation, ie is subjective, just like haccp.

There have been an innumerable number of Decision trees/methodologies proposed for determining as to whether a control measure for a significant hazard in the iso-haccp context should be associated with an oprp or CCP. From an auditorial POV, any implemented tree/methodology is likely to be acceptable if it is "logical" and can be "adequately" correlated to the Standard's text (and possibly to the auditor's working experience).

 

This thread/discussion of OPRP/CCP differentiation for iso22000:2018 may be of some interest to you -

 

https://www.ifsqn.co...18/#entry136663

 

Here is a model example of  hazard analysis - CCP/OPRP categorization which was developed for fssc22000 /  iso22000:2005 -

 

http://www.ifsqn.com...ge-7#entry50651

 

 

The iso22000 Guidance document iso22004:2005 commented -

Categorization of control measures: The organization may focus on having as many of the control measures as possible managed by operational PRPs and only a few managed by the HACCP plan, or the opposite. It should be noted that, in certain cases, no CCP can be identified, for example because monitoring results cannot be provided within an adequate time frame.

As the effects of the combination of control measures are validated prior to categorization, food safety will be achieved in cases even when all control measures are to be managed through operational PRPs.

 Nonetheless if, for example, you designate a particular control measure as an OPRP when an auditor has routinely encountered  it elsewhere set as a CCP a "lively" discussion can be anticipated.

[Evez]

Thanks Tony and Charles.

 

This Q4 subquestions really confused us during the audit time.
We considered Metal Detection as CCP as this is already the last step.

Auditor is asking question on the assessment following the Q4:
 

- The effect on the hazard  -if the bag contains metallic, the size can be 'exactly' measured once it's passed thru MD; it will just give us indication that it has FM inside. so you'll just know if there is significant hazard once the FM is extracted. even if there is an added task for to determine this, can we consider a YES answer for this subquestion?

- Control measure specifically applied to reduce to acceptable level? passing a bag thru MD will not remove or reduce the foreign matter inside the bag. but we can segregate to check and remove the FM that maybe present. can we consider a YES for this subquestion?
- Any subsequent control measures? No (last control); or can we answer YES and declare inspection of the bag that triggered alam so we can move to Q5?
- Single control measure or combination? Yes (Sieve & Magnet prior to Metal Detection)

If NO, Categorize the control measure as an OPRP.

 

 

also found this statement in Guidance document: ISO 22000 Interpretation FSSC 22000 Version 5 | December 2019 (page 8):

"Despite high likelihood x severity of failure of control measures on food safety, when the feasibility of measurement to detect and correct of failure is low, a CCP cannot be established. In ISO 22000 this type of control measure is also identified as an OPRP. To express low feasibility of measure, ISO 22000:2018 uses the expression "observation" for OPRP, as counterpart of "measurement" for CCP.

 

 

[Charles.C]

Thanks Tony and Charles.

 

This Q4 subquestions really confused us during the audit time.
We considered Metal Detection as CCP as this is already the last step.

Auditor is asking question on the assessment following the Q4:
 

- The effect on the hazard  -if the bag contains metallic, the size can be 'exactly' measured once it's passed thru MD; it will just give us indication that it has FM inside. so you'll just know if there is significant hazard once the FM is extracted. even if there is an added task for to determine this, can we consider a YES answer for this subquestion?

- Control measure specifically applied to reduce to acceptable level? passing a bag thru MD will not remove or reduce the foreign matter inside the bag. but we can segregate to check and remove the FM that maybe present. can we consider a YES for this subquestion?
- Any subsequent control measures? No (last control); or can we answer YES and declare inspection of the bag that triggered alam so we can move to Q5?
- Single control measure or combination? Yes (Sieve & Magnet prior to Metal Detection)

If NO, Categorize the control measure as an OPRP.

 

 

also found this statement in Guidance document: ISO 22000 Interpretation FSSC 22000 Version 5 | December 2019 (page 8):

"Despite high likelihood x severity of failure of control measures on food safety, when the feasibility of measurement to detect and correct of failure is low, a CCP cannot be established. In ISO 22000 this type of control measure is also identified as an OPRP. To express low feasibility of measure, ISO 22000:2018 uses the expression "observation" for OPRP, as counterpart of "measurement" for CCP.

 Hi Evez,

 

TBH, my recommendation is that you abandon the Guidance methodology for a simpler, time-tested, Procedure (eg based on that of CocaCola). IMO the former example  is causing you unwarranted "logic" headaches.