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Difference b/w Potentially Unsafe Product and Non-conforming Product

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S.U.Siddiqui

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Posted 28 April 2009 - 05:51 AM

Dear All,

I have been in real confusion in the past and hence decided to discuss this issue regarding the terminologies of Potentially Unsafe Product and Non-conforming Product.

In clause 7.6.5, standard uses the word of POTENTIALLY UNSAFE PRODUCT for the first time and requires a DOCUMENTED PROCEDURE for handling such product.

However when standard discusses the handling of PUP in clause 7.10.3.1 titled as "HANDLING OF POTENTIALLY UNSAFE PRODUCTS" the statement is changed and the product is referred as "NON CONFORMING PRODUCT".

As far as i think, a potentially unsafe product is a doubtful product i.e. IT MAY CAUSE HARM TO ITS CONSUMER, however a NON-CONFORMING PRODUCT is confirmed as UNSAFE PRODUCT and hence IT WILL CAUSE HARM TO ITS CONSUMER.

Hence in this scenario, i suggest to TC-34 to replace the words of NONCONFORMING PRODUCT with potentially unsafe product in the first line of 7.10.3.1

Am i right? Please clarify the point.

Regards
Siraj



Raj21

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Posted 28 April 2009 - 10:20 AM

Yes Mr.Siddiqui,

You are absoutely right.

It is similar as difference between a manufactured lot which is kept on hold(under test due to a significant level of doubt) and the one which is Rejected and needs to be dealt with as per the disposal procedures defined.

Regards,
Rajesh Naik.



Erasmo

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Posted 28 April 2009 - 11:53 AM

Dear All,

I have been in real confusion in the past and hence decided to discuss this issue regarding the terminologies of Potentially Unsafe Product and Non-conforming Product.

In clause 7.6.5, standard uses the word of POTENTIALLY UNSAFE PRODUCT for the first time and requires a DOCUMENTED PROCEDURE for handling such product.

However when standard discusses the handling of PUP in clause 7.10.3.1 titled as "HANDLING OF POTENTIALLY UNSAFE PRODUCTS" the statement is changed and the product is referred as "NON CONFORMING PRODUCT".

As far as i think, a potentially unsafe product is a doubtful product i.e. IT MAY CAUSE HARM TO ITS CONSUMER, however a NON-CONFORMING PRODUCT is confirmed as UNSAFE PRODUCT and hence IT WILL CAUSE HARM TO ITS CONSUMER.

Hence in this scenario, i suggest to TC-34 to replace the words of NONCONFORMING PRODUCT with potentially unsafe product in the first line of 7.10.3.1

Am i right? Please clarify the point.

Regards
Siraj


Hi,
The answer is in other requirement. All PUP has to be evaluated (7.10.3.2), if the result of the evaluation is that the product is a non-conforming product, you have only 2 options (7.10.3.3):
Re-work (if its possible), or
Discard (that is always possible),

in some ocasions you can realease a PUP as a result of the evaluation.


S.U.Siddiqui

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Posted 29 April 2009 - 04:53 AM

Hi, thanks for the prompt reply

I totally agree with the points but my suggestion is again valid. The terminology used twice in the first line of 7.10.3.1 is wrong. It shall be POTENTIALLY UNSAFE PRODUCT (Doubt) rather than NON CONFORMING PRODUCT (Confirm).

That's what i think....

Regards
Siraj



S.U.Siddiqui

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Posted 13 May 2009 - 09:27 AM

Any one... Pleas clarify the point.. I am in real confusion


Regards
Siraj



Erasmo

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Posted 13 May 2009 - 04:02 PM

Any one... Pleas clarify the point.. I am in real confusion


Regards
Siraj


Hi Siraj,
I hope this diagram can help you. Just remember: Sometimes it wont be feasible or possible to make an evaluation of a PUP, and sometimes rework is not a possibility.

Attached Files



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S.U.Siddiqui

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Posted 14 May 2009 - 06:10 AM

Dear Erasmo,

Nice figure, really. But dont u think that 7.10.3.1 wrongly states Potentially unsafe product as Non-conforming product? Do reply, its open for everyone.

Regards
Siraj



Saviour

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Posted 14 May 2009 - 07:43 AM

Dear Siraj

Before we discuss this point I will request you to again read this clause and focus on
highlights.

7.10.3 Handling of potentially unsafe products

7.10.3.1 General

The organization shall handle nonconforming products by taking action(s) to prevent the nonconforming product from entering the food chain unless it is possible to ensure that

a) the food safety hazard(s) of concern has(ve) been reduced to the defined acceptable levels,

b) the food safety hazard(s) of concern will be reduced to identified acceptable levels (see 7.4.2) prior to entering into the food chain, or

c) the product still meets the defined acceptable level(s) of the food safety hazard(s) of concern despite the nonconformity.

All lots of product that may have been affected by a nonconforming situation shall be held under control of the organization until they have been evaluated.

If products that have left the control of the organization are subsequently determined to be unsafe, the organization shall notify relevant interested parties and initiate a withdrawal (see 7.10.4).

NOTE The term “withdrawal” includes recall.

The controls and related responses and authorization for dealing with potentially unsafe products shall be documented.

Now coming to the valid point

NON CONFORMING PRODUCT is the product that has been deviated from its required process/ quality parameter.
Whereas POTENTIALLY UNSAFE PRODUCT is the product where there is doubt that due to this deviation/ non conformity product may become unsafe for consumption.

Thus product may still remain nonconforming but safe for consumption.

In other words
ALL NON CONFORMING PRODUCT ARE NOT ALWAYS POTENTIALLY UNSAFE
HOWEVER
ALL POTENTIALLY UNSAFE PRODUCTS ARE ALWAYS NONCONFORMING.



If the product is detected as potentially unsafe then ‘The controls and related responses and authorization for dealing with potentially unsafe products shall be documented.’

If product is tested as safe

7.10.3.2 Evaluation for release

Each lot of product affected by the nonconformity shall only be released as safe when any of the following conditions apply:

a) evidence other than the monitoring system demonstrates that the control measures have been effective;

b) evidence shows that the combined effect of the control measures for that particular product complies with the performance intended (i.e. identified acceptable levels as identified in accordance with 7.4.2);

c) the results of sampling, analysis and/or other verification activities demonstrate that the affected lot of product complies with the identified acceptable levels for the food safety hazard(s) concerned.

If the product tested as unsafe

7.10.3.3 Disposition of nonconforming products

Following evaluation, if the lot of product is not acceptable for release it shall be handled by one of the following activities:

a) reprocessing or further processing within or outside the organization to ensure that the food safety hazard is eliminated or reduced to acceptable levels;

b) destruction and/or disposal as waste.

That’s why this terminology NON CONFORMING PRODUCT is been used in

Clause 7.10.3 Handling of potentially unsafe products

Regards


Edited by Saviour, 14 May 2009 - 07:53 AM.


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Erasmo

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Posted 14 May 2009 - 02:51 PM

Dear Erasmo,

Nice figure, really. But dont u think that 7.10.3.1 wrongly states Potentially unsafe product as Non-conforming product? Do reply, its open for everyone.

Regards
Siraj


No, I think the Standard is OK. Remember that sometimes you need confirmation to declare a product as a non-conforming product. that will depend of the nature of the validation, the nature of the process and the nature of the product.


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S.U.Siddiqui

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Posted 15 May 2009 - 03:44 AM

Dear Savior,

I appreciate the discussion you have made in this topic but I strongly disagree with your point.

Just try to imagine if some one says that Product XYZ is a non-conforming product it means he/she is SURE (not doubtful) about the non-conformance of that product. When we consider it w.r.t food safety, a non-conforming product means an unsafe product b/c it "does not conform with the requirements" (ISO9000- Terminology) of food safety.

Whereas, a potentially unsafe product is a doubtful product i.e. it has the potential to be unsafe. Hence it shall be evaluated for release.

NON CONFORMING PRODUCT is the product that has been deviated from its required process/ quality parameter.


Remember that ISO22000 does not focus on QUALITY. Its main focus is FOOD SAFETY. Quality is dealt with ISO9001 as it is titled "Quality Management System". Now if i modify your definition w.r.t food safety it becomes:

Non conforming product is the product that has been deviated from its required FOOD SAFETY parameters.

This parameter can either be OPRP or CCP, hence in this situation the product will become POTENTIALLY UNSAFE (according to 7.10.1, second last paragraph) not NON-CONFORMING.

Further more, according to 7.10.3.1,

"All lots of product that may have been affected by a nonconforming SITUATION shall be held under control of the organization until they have been evaluated"

It clearly suggest that it is not necessary that a product which is affected by a NONCONFORMING SITUATION becomes a NON-CONFORMING PRODUCT. If this would have been the case, there would have been no requirement of Evaluation.

Kindly, provide a reference of your definition of NON-CONFORMING PRODUCT :rolleyes: .

Regards
Siraj


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Bhavna

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Posted 26 June 2015 - 05:14 AM

Hi,

 

Got clear idea related to the diff. between non-conforming & potentailly unsafe product.

 

Will anyone of you tell me ,can I merge SOP of these two product in one SOP ??

 

And also please do share the SOP for handling Potentially Unsafe Product and Non -conforming product .

 

 

 

Thanks a lot,

 

Bhavna



arun potdar

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Posted 29 September 2015 - 07:24 AM

siraj , i fully endorse your views.

arun potdar





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