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Best Answer David@sher, 29 April 2015 - 07:53 PM

I generally identify 5 classes of physical hazards: the first is physical hazards not associated with foreign bodies, e.g. packaging injuries... the remaining four are foreign bodies.
A) low severity - FBs that can't really harm you but are disgusting. Hair, insects...
B) medium severity - FBs that can break teeth: stones, bolts, pits...
C) high severity - FBs that cause laceration - sharps, glass...
D) High severity - choking hazards - only for infant food Go to the full post


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#1 bowmank

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Posted 28 April 2015 - 12:36 PM

Hi,

 

 

I am currently in the process of reviewing and re-writing our foreign body risk assessment. I am using a HACCP based approach for this and was wondering if anyone has a risk matrix with clear justifications on. Our current risk assessment has a 3 stepped matric for severity and likelihood and while I am happy with the categories, I would like to find model with a more defined description of what facilitates a 1, 2 or 3 rating. For example Severity 1 = minor discomfort…

 

Can anyone help please!!



#2 Charles.C

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Posted 28 April 2015 - 08:15 PM

Hi,

 

 

I am currently in the process of reviewing and re-writing our foreign body risk assessment. I am using a HACCP based approach for this and was wondering if anyone has a risk matrix with clear justifications on. Our current risk assessment has a 3 stepped matric for severity and likelihood and while I am happy with the categories, I would like to find model with a more defined description of what facilitates a 1, 2 or 3 rating. For example Severity 1 = minor discomfort…

 

Can anyone help please!!

 

This parallel thread perhaps -

 

http://www.ifsqn.com...rix/#entry88331


Kind Regards,

 

Charles.C


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#3 xylough

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Posted 29 April 2015 - 12:41 AM

Hi bowmank,

 

Two considerations in addition to the fine matrices Charles has provided.

 

I have observed that it is often convention in the US to use or at least include the verbiage already enshrined in the food code for Class 1, 2 and 3 recalls as the verbiage used in a hazard risk matrix. The triggers and levels of hazard already identified and used by the enforcers of the food code. If you desired you could create additional descriptions in your matrix for lesser hazard risks, e. g., you have identified a problem, but the product is still in your possession and under your control, not having entered commerce.

 

7.1.1.2
Recall Classification
Recall Class
ification is
the numerical designation, i.e., I, II,
or III, assigned by the FDA to a particular product recall to
indicate the relative degree of health hazard presented by
the product being recalled.
7.1.1.2.1
-
CLASS I RECALL
Class I Recall is a
situati
on in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences
or death.
7.1.1.2.2
-
CLASS II RECALL
Class II Recall is a
situation in which use of, or exposure
to, a violat
ive product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
7.1.1.2.3
-
CLASS III RECALL
Class III Recall is a
situation in which use of, or exposure
to, a violative product is not not likely to cause adverse health
consequences.

Another way to approach the hazard risk assessment is to augment known historical data of instances of foreign body events that triggered recalls with the data from your own customer complaints tracking and trending logs regarding foreign body discovery from your products in the market.



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#4 bowmank

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Posted 29 April 2015 - 06:59 AM

Thanks for these comments, however I understand the matrix system and have used in health and safety.

 

I was really after definitions as you would have in a health and safety risk assessment i.e. severity 1 = insignificant; 2 = minor injury; 3 = major injury... etc.

 

I wondered if there was anything out there already or if I will have to invent my own terms of reference for each score.  



#5 Charles.C

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Posted 29 April 2015 - 09:21 AM

Thanks for these comments, however I understand the matrix system and have used in health and safety.

 

I was really after definitions as you would have in a health and safety risk assessment i.e. severity 1 = insignificant; 2 = minor injury; 3 = major injury... etc.

 

I wondered if there was anything out there already or if I will have to invent my own terms of reference for each score.  

 

Hi bowmank,

 

Did you actually see the matrix examples linked in my post.?

 

Do they not answer yr query ?

 

If not, please clarify why not so as to enable a more accurate response.

 

Perhaps you are seeking details on exactly why a particular foreign body, eg material/shape/diameter value is associated with a severity of 1 or 2 or whatever ? that is going to be a little more complicated. :smile:

 

IMEX, many foreign body hazards in, say, raw materials are simply defined as Prerequisite controlled. So no need to worry about matrices. :smile:

 

If occurring within the main process i typically award such hazards a severity of "M" but perhaps depending on, for example, the material so that the conclusion as to a significant hazard (ie the risk) will then depend on the likelihood of their occurrence. This is all subjective logic of course. There is no such entity as an absolute risk matrix.

 

Some criteria/SOP for deciding between Prerequisite and CCP in raw materials have also been published. I can post the reference if you are interested


Kind Regards,

 

Charles.C


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#6 David@sher

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Posted 29 April 2015 - 07:53 PM   Best Answer

I generally identify 5 classes of physical hazards: the first is physical hazards not associated with foreign bodies, e.g. packaging injuries... the remaining four are foreign bodies.
A) low severity - FBs that can't really harm you but are disgusting. Hair, insects...
B) medium severity - FBs that can break teeth: stones, bolts, pits...
C) high severity - FBs that cause laceration - sharps, glass...
D) High severity - choking hazards - only for infant food



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#7 Charles.C

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Posted 29 April 2015 - 09:56 PM

I generally identify 5 classes of physical hazards: the first is physical hazards not associated with foreign bodies, e.g. packaging injuries... the remaining four are foreign bodies.
A) low severity - FBs that can't really harm you but are disgusting. Hair, insects...
B) medium severity - FBs that can break teeth: stones, bolts, pits...
C) high severity - FBs that cause laceration - sharps, glass...
D) High severity - choking hazards - only for infant food

 

AFAIK, the defects noted in A) are not classified as safety-related so technically have no severity rating. They are disregarded from a HACCP POV..

 

I have not previously seen such a table in the literature. Is there any validation available ?


Kind Regards,

 

Charles.C


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#8 David@sher

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Posted 30 April 2015 - 04:21 AM

Good point, Charles!

 

Nauseating foreign bodies in many organizations do fall under HACCP... ISO 22000 defines a food safety hazard as a: "biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect". Feeling disgusted with your food to the point of feeling nausea due to the presence of objectionable foreign bodies such as hair, insects, fingernails, slime, etc. is considered by many as a food safety hazard, albeit a hazard of low severity. As an auditor, if an organization chooses this approach it is acceptable, and if the organization chooses to exclude these, and manage them as quality issues, it is acceptable as well.

 

As for this classification in literature, I doubt if it has been academically documented, however it is the outcome of over 20 years experience and hundreds of risk assessments. Determining severity for various hazards can be challenging, and this is just a practical guideline that can help.



#9 Charles.C

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Posted 30 April 2015 - 06:52 AM

Good point, Charles!

 

Nauseating foreign bodies in many organizations do fall under HACCP... ISO 22000 defines a food safety hazard as a: "biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect". Feeling disgusted with your food to the point of feeling nausea due to the presence of objectionable foreign bodies such as hair, insects, fingernails, slime, etc. is considered by many as a food safety hazard, albeit a hazard of low severity. As an auditor, if an organization chooses this approach it is acceptable, and if the organization chooses to exclude these, and manage them as quality issues, it is acceptable as well.

 

As for this classification in literature, I doubt if it has been academically documented, however it is the outcome of over 20 years experience and hundreds of risk assessments. Determining severity for various hazards can be challenging, and this is just a practical guideline that can help.

 

Thanks for the comments. I do recall some previous proposals/threads here to formally introduce Psychological factors into HACCP. :smile:

 

In fact support for including hair within "Physical Hazards", together with a long list of other objects such as writing pens, feathers, string does exist as per the (first) link/sub links in this post -

 

http://www.ifsqn.com...indpost&p=83880

 

However a classification intended to focus on (Physical?) Safety presumably has to exercise some degree of selectivity.

 

For me, the step from A) to B) is  Apples to Oranges.

 

IMO,  A) is simply redundant.

 

The step from B) to C) seems more logical and particularly in view of FDA 's, data-based, highlighting of hard/sharp objects. Whether the associated levels should be from (L to M) or (M to H) is of course subjective. In fact it could be argued that a Y x 2 matrix is inadequate to cope. Or even a Y x 3 for that matter.

 

I totally agree an Organisation is responsible for it's own Policies. If in the present case,  any associated Procedures contained a rider stating something like unaligned to, say Codex / NACMCF, this would be nearer acceptability from my POV.

 

As an alternative route to the present discussion, particularly from a HACCP POV,,  the logic/methodology implemented by Kraft seemed quite effective to me. A partial extract from their SOP is here (at end of the post) -

 

http://www.ifsqn.com...indpost&p=83137

 

It's an interesting thread :thumbup:


Kind Regards,

 

Charles.C


#10 bowmank

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Posted 01 May 2015 - 08:57 AM

Thanks for the comments. I do recall some previous proposals/threads here to formally introduce Psychological factors into HACCP. :smile:

 

In fact support for including hair within "Physical Hazards", together with a long list of other objects such as writing pens, feathers, string does exist as per the (first) link/sub links in this post -

 

http://www.ifsqn.com...indpost&p=83880

 

However a classification intended to focus on (Physical?) Safety presumably has to exercise some degree of selectivity.

 

For me, the step from A) to B) is  Apples to Oranges.

 

IMO,  A) is simply redundant.

 

The step from B) to C) seems more logical and particularly in view of FDA 's, data-based, highlighting of hard/sharp objects. Whether the associated levels should be from (L to M) or (M to H) is of course subjective. In fact it could be argued that a Y x 2 matrix is inadequate to cope. Or even a Y x 3 for that matter.

 

I totally agree an Organisation is responsible for it's own Policies. If in the present case,  any associated Procedures contained a rider stating something like unaligned to, say Codex / NACMCF, this would be nearer acceptability from my POV.

 

As an alternative route to the present discussion, particularly from a HACCP POV,,  the logic/methodology implemented by Kraft seemed quite effective to me. A partial extract from their SOP is here (at end of the post) -

 

http://www.ifsqn.com...indpost&p=83137

 

It's an interesting thread :thumbup:

 

 

Good point, Charles!

 

Nauseating foreign bodies in many organizations do fall under HACCP... ISO 22000 defines a food safety hazard as a: "biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect". Feeling disgusted with your food to the point of feeling nausea due to the presence of objectionable foreign bodies such as hair, insects, fingernails, slime, etc. is considered by many as a food safety hazard, albeit a hazard of low severity. As an auditor, if an organization chooses this approach it is acceptable, and if the organization chooses to exclude these, and manage them as quality issues, it is acceptable as well.

 

As for this classification in literature, I doubt if it has been academically documented, however it is the outcome of over 20 years experience and hundreds of risk assessments. Determining severity for various hazards can be challenging, and this is just a practical guideline that can help.

 

 

AFAIK, the defects noted in A) are not classified as safety-related so technically have no severity rating. They are disregarded from a HACCP POV..

 

I have not previously seen such a table in the literature. Is there any validation available ?

 

 

I generally identify 5 classes of physical hazards: the first is physical hazards not associated with foreign bodies, e.g. packaging injuries... the remaining four are foreign bodies.
A) low severity - FBs that can't really harm you but are disgusting. Hair, insects...
B) medium severity - FBs that can break teeth: stones, bolts, pits...
C) high severity - FBs that cause laceration - sharps, glass...
D) High severity - choking hazards - only for infant food

Hi,

 

Just to clarify, I am using a HACCP based approach not completing a HACCP study. This will sit independently from HACCP along with our speciation R/A and allergen R/A. Thanks for your comments I have enjoyed watching how this has panned out.

 

Kevin



#11 Charles.C

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Posted 01 May 2015 - 06:13 PM

Hi Kevin,

 

The fact is that from A HACCP / Risk Assessment POV, BCP Categories of Hazards are not necessarily, intrinsically, regarded as created equal. More specifically, Harm to an individual is a too-narrow perspective. In this respect a matrix such as discussed in this thread which ignores relative prioritization  is possibly, fundamentally, flawed.

 

More comprehensive risk assessment publications / QMRAs expand on this aspect, eg include “exposure” factors.Tie-line RAs are one practical implementation of the larger picture viewpoint. Another expanded direction is FMEA although chronologically HACCP is better considered a subset of FMEA rather than the reverse. In practice many haccp users intuitively apply some of the conclusions from such documents but without detailing them in their conventionally presented matrix, eg for predicted severity of microbial hazards as compared to physical.

 

Some more titbits for the pan. :biggrin:


Kind Regards,

 

Charles.C


#12 syju28380

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Posted 07 October 2015 - 06:20 AM

Hi,

 

You may find this useful

 

Syju

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