Clause 7.6.3 - determination of critical limits for ccp

hi, all,

need some help here, any idea or kindly explain on clause 7.6.3?

"Critical limits based on subjective data (such as visual inspection of product,process,handling, etc.) shall be supported by instructions or specifications and or education and training." Thank You.

hi, all,

 

need some help here, any idea or kindly explain on clause 7.6.3?

 

"Critical limits based on subjective data (such as visual inspection of product,process,handling, etc.) shall be supported by instructions or specifications and or education and training." Thank You.

Dear Ralh,

it means validation is required.

Rgds / Charles.C

i cant really understand the "subjective data". can you explain or give an example regarding this? my head is gonna explode. :headhurts:

i cant really understand the "subjective data". can you explain or give an example regarding this? my head is gonna explode. :headhurts:

Dear Ralh,

it presumably means a significant (safety) hazard classified as CCP but where you can only set a non-quantitative critical limit.

I don't think I have ever met one (have you?), but probably more likely to anyway classify as OPRP (strictly no critical limit but validation still required) such as defective segregation between high/low risk areas /  visual control.

These days, most of such possibilities are, IMO, included within PRP programs but ISO people thought a bit differently in 2005. :smile:

Rgds / Charles.C

Hello Mr RALH.

   CCP based on Subjective data like visual Inspection is normally practised by Chefs in restaurants like roasting/grilling or smoking of the products,where he observes the color change of the product while grilling etc.How ever this has to be validated and such training may be provided to trianee chefs etc.and supported by SOP.

Dear Sushil,

Ingenious suggestion but I am dubious as to its ISO 22000 validity.

One of the primary reasons for the original introduction of the  “OPRP” program was to handle situations where a hazard was risk-assessed as a  potential / necessary  “CCP”  but quantitative critical limits could not be readily  allocated/validated. Subsequently, the interpretation has “enlarged”.

A similar approach to yr idea is seen  in the SFBB (safer food better business) system in UK. This was  implemented in certain business applications, eg catering, so as to satisfy the compulsory requirements of  the haccp portion of the ca.2006 EC food safety directive. (Attempts to implement a formal haccp approach were found impractical, ie technically too difficult for intended users).

The UK text  is careful to note  –

“This pack is based on the principles of HACCP (hazard analysis and critical control point), but you will not find words such as ‘HACCP’ or ‘hazard’ in the pack because we have cut out all the jargon.” Nor will you find any reference to CCP. Have attached document below if anyone interested.

One might (generously?) call this an “informal” haccp methodology.

In above case, the validation of the  “critical limit”  was that the methodology was officially issued/auto-approved.

I can see the attractiveness of  a similar approach for ISO 22000 in the industries mentioned but I doubt that this was the intended purpose of the text under current discussion. Also doubt that  this interpretation would be acceptable in an audit for compliance to the ISO 22000 standard.

However only too willing to be convinced by some data – can you elaborate on its application (in India?) / supply any links to the published  acceptability of this interpretation for ISO 22000 purposes ?

sfbb-catering.pdf   2.31MB   67 downloads

Rgds / Charles.C

It can often mean the user of visual standards which indicate a 'Pass', 'Fail' and 'Pass but near to failure'. This would of course refer to critical limits. It can also mean actual physical examples of a defect e.g. the quality of seam on a can in a canning process where a visual inspection of a double seam is used to control the process (not ideal). 

In short, the clause is seeking to remove the subjective nature of the control where the result could vary from inspector to inspector. 

George

hi, all,

 

need some help here, any idea or kindly explain on clause 7.6.3?

 

"Critical limits based on subjective data (such as visual inspection of product,process,handling, etc.) shall be supported by instructions or specifications and or education and training." Thank You.

Hi Ralh,

A good example is in aseptic packing where seals are critical to the integrity of the product and maintaining sterility.

Operators carrying out seal checks need to be clear on what is acceptable and not acceptable. Training, instructions, visual standards and operator assessment are required to ensure that operators are competent to carry out this task.

Here is an example of how subjective testing is supported by visual standards.

Subjective Testing of Package Integrity.pdf   521.35KB   69 downloads

Regards,

Tony

2 quotes from same section of the standard.

(a) Critical limits shall be measurable.

 

(b) Critical limits based on subjective data (such as visual inspection of ……) shall be supported by instructions or specifications and/or education and training.

 

IMO most haccp critical limits are subjective, regardless of whether being based on (1) directly  quantitated parameters, eg temperature, or (2) more descriptive gradings such as  visually evaluated hazards.

The section under current discussion comes after sections such as  7.4.4 .

I suggest that the type (2) hazard is relatively unlikely to qualify as a CCP-related feature when assesssed as per the validatory  / (a-f) categories of the standard.

(this IMO was a causal reason for introducing OPRP)

I’m still intrigued as to the  validation of  a cooking critical limit based on meat colour. By (bitter?) experience perhaps ?. Regardless, the practice persists. How about verification ? :smile:

Rgds / Charles.C

2 quotes from same section of the standard.

 

IMO most haccp critical limits are subjective, regardless of whether being based on (1) directly  quantitated parameters, eg temperature, or (2) more descriptive gradings such as  visually evaluated hazards.

 

The section under current discussion comes after sections such as  7.4.4 .

 

I suggest that the type (2) hazard is relatively unlikely to qualify as a CCP-related feature when assesssed as per the validatory  / (a-f) categories of the standard.

(this IMO was a causal reason for introducing OPRP)

 

I’m still intrigued as to the  validation of  a cooking critical limit based on meat colour. By (bitter?) experience perhaps ?. Regardless, the practice persists.

 

Rgds / Charles.C

You make a good point there Charles.

I don't necessarily agree that all critical limits are subjective (temperature?) but perhaps that by nature of the prescribed criteria in the 22000 standard any control point which is judged by subjective criteria could be categorised as an OPRP based on clause 7.4.4 b) its feasibility for monitoring ?

Regards,

Tony