16 replies to this topic

[Rudra]

Hello guys,
I am very disappointed with the results of my audit ISO 22000:2005. I need to answer these non conformity within 2 days. Please help me.

1) Non conformance: It was noted that the chemical characteristics which are relevant for feed safety were not included in the product description of the end products ( for example moisture content)

My question : Is moisture content of food a chemical?
Actually I have 2 CCPs in my process:
Moisture content <12% so as to control microbial growth
Product temperature should be < Ambient Temp by 5 degrees Celcius.
How can I validate these CCPs? Any theory?


2) Non conformance: The method of distribution was not indicated in the end products description documents?
My question: What does method of distribution means according to ISO 22000?

3) Non conformance:The procedure for managing potential emergency situations (power failure, flooding and sabotage ) was not seen in the FSMS manual.
Question : Any procedure?

4) Non Conformance: The unintended but reasonably expected mishandling and misuse of the end products was not seen in the FSMS manual.
I dont understand this.

Please help

Rudra

[HPG]

Hello guys,
I am very disappointed with the results of my audit ISO 22000:2005. I need to answer these non conformity within 2 days. Please help me.

1) Non conformance: It was noted that the chemical characteristics which are relevant for feed safety were not included in the product description of the end products ( for example moisture content)

My question : Is moisture content of food a chemical?
Actually I have 2 CCPs in my process:
Moisture content <12% so as to control microbial growth
Product temperature should be < Ambient Temp by 5 degrees Celcius.
How can I validate these CCPs? Any theory?


2) Non conformance: The method of distribution was not indicated in the end products description documents?
My question: What does method of distribution means according to ISO 22000?

3) Non conformance:The procedure for managing potential emergency situations (power failure, flooding and sabotage ) was not seen in the FSMS manual.
Question : Any procedure?

4) Non Conformance: The unintended but reasonably expected mishandling and misuse of the end products was not seen in the FSMS manual.
I dont understand this.

Please help

Rudra

Dear Rudra,
1. You can include product description in your characteristic of end products (shape, color, aroma, taste etc. including moisture content)
2. Section 7.3.3.2 point g --> method(s) of distribution. You can write how you distribute your product (ship, truck etc), city or region or country that you sell your
products
3. You can try search in ISO 22000 forum. There are some great topics that are related to emergency preparedness

Rgds,
Hadi

[Charles.C]

Hello guys,
I am very disappointed with the results of my audit ISO 22000:2005. I need to answer these non conformity within 2 days. Please help me.

1) Non conformance: It was noted that the chemical characteristics which are relevant for feed safety were not included in the product description of the end products ( for example moisture content)

My question : Is moisture content of food a chemical?
Actually I have 2 CCPs in my process:
Moisture content <12% so as to control microbial growth
Product temperature should be < Ambient Temp by 5 degrees Celcius.
How can I validate these CCPs? Any theory?


2) Non conformance: The method of distribution was not indicated in the end products description documents?
My question: What does method of distribution means according to ISO 22000?

3) Non conformance:The procedure for managing potential emergency situations (power failure, flooding and sabotage ) was not seen in the FSMS manual.
Question : Any procedure?

4) Non Conformance: The unintended but reasonably expected mishandling and misuse of the end products was not seen in the FSMS manual.
I dont understand this.

Please help

Rudra

Dear Rudra,

I think HPG has given you good advice.

I also didn’t understand yr No.4, what para. in the standard was involved ?

The probable reason for the auditor query No.2 was that the method of distribution had possible significance with respect to safety, for example a frozen finished product requires refrigerated trucks for onward transport.

I understand for yr No.1 that the auditor did not accept the validation of yr moisture CCP. I don’t work in the feed business but why did you select 12% in yr plan as the maximum moisture content for preventing microbial growth ?
The critical limit will depend on the specific hazard in yr process / haccp plan, eg things like mould / mycotoxin / Salmonella ?? What “species” did you specify in yr haccp plan (I assume it was acceptable to the auditor?) ?

Just as an example, I noticed this comment for grain where mycotoxin was the hazard–

The most effective mycotoxin control measures is to dry the commodity such that the water activity (aw) is too low to support mould growth and/or prevent mycotoxin production. To prevent the growth of most moulds the aw needs to be £ 0.70, which translates to a moisture content of approximately 14% for maize and 7.0% for groundnuts at 20°C (the corresponding moisture content decreases as the temperature increases). Each toxigenic mould has its own minimum water activity for growth and mycotoxin production and these translate into moisture contents for each commodity. These moisture contents are termed 'safe' and would be the critical limit for the control measure.

http://www.fao.org/docrep/005/y1390e/y1390e0b.htm

Rgds / Charles.C

[Rudra]

Dear Rudra,

I think HPG has given you good advice.

I also didn’t understand yr No.4, what para. in the standard was involved ?

The probable reason for the auditor query No.2 was that the method of distribution had possible significance with respect to safety, for example a frozen finished product requires refrigerated trucks for onward transport.

I understand for yr No.1 that the auditor did not accept the validation of yr moisture CCP. I don’t work in the feed business but why did you select 12% in yr plan as the maximum moisture content for preventing microbial growth ?
The critical limit will depend on the specific hazard in yr process / haccp plan, eg things like mould / mycotoxin / Salmonella ?? What “species” did you specify in yr haccp plan (I assume it was acceptable to the auditor?) ?

Just as an example, I noticed this comment for grain where mycotoxin was the hazard–

http://www.fao.org/d...0e/y1390e0b.htm

Rgds / Charles.C

Thanks guys.
Another non conformity was :
The product descriptions for the raw materials (for e.g cereal, additives, fish and crustacean meals) were not seen in the FSMS manual.
any format for this?


Rudra

[HPG]

Dear Rudra,
Charles has made a good point for moisture content.
Usually Aw is considered to control microbial growth (But I don't have any experience in feed industry, so I don't know if it's commonly used)

Thanks guys.
Another non conformity was :
The product descriptions for the raw materials (for e.g cereal, additives, fish and crustacean meals) were not seen in the FSMS manual.
any format for this?


Rudra

Do you have HACCP Plan?
Raw Materials, Packagings and Products Characteristics usually specify in HACCP Plan.
Format for Raw Material Characteristics is described in section 7.3.3.1.
You can make columns based on that section.

Rgds,
Hadi

Edited by HPG, 04 March 2013 - 01:39 AM.

[Charles.C]

Thanks guys.
Another non conformity was :
The product descriptions for the raw materials (for e.g cereal, additives, fish and crustacean meals) were not seen in the FSMS manual.
any format for this?

Rudra

Dear Rudra,

Regarding my previous post, i noticed your earlier thread contained an attachment of a haccp plan for animal feed -

http://www.ifsqn.com...dpost__p__57856

In that case, the initial input hazard was apparently mycotoxins. There, the control was implemented by (real-time) sampling / analysis of mycotoxin content in ingredients at time of reception. I believe this is a common alternative to using moisture as a CCP but maybe required more analytical expertise than you have available. It does avoid the validation complexities though.

As noted previous post, details of range of possible required characteristics for "Product Specifications" are given in the standard. As examples of some of the possibilities, here are two documents previously posted by Tony-C for an ISO22000 yoghurt thread -

 t1 - SkimMilkPowder_spec1.pdf   68.36KB   138 downloads

 t2 - Drywheyspec.pdf   53.72KB   114 downloads

Different types of ingredient will vary in their specific content and emphasis of course.

Most people draft the input specifications at the beginning of FS project because (a) first step in most flow charts, (b) rather difficult to start the hazard analysis without them.

Rgds / Charles.C

[Rudra]

Dear Rudra,

Regarding my previous post, i noticed your earlier thread contained an attachment of a haccp plan for animal feed -

http://www.ifsqn.com...dpost__p__57856

In that case, the initial input hazard was apparently mycotoxins. There, the control was implemented by (real-time) sampling / analysis of mycotoxin content in ingredients at time of reception. I believe this is a common alternative to using moisture as a CCP but maybe required more analytical expertise than you have available. It does avoid the validation complexities though.

As noted previous post, details of range of possible required characteristics for "Product Specifications" are given in the standard. As examples of some of the possibilities, here are two documents previously posted by Tony-C for an ISO22000 yoghurt thread -

 t1 - SkimMilkPowder_spec1.pdf   68.36KB   138 downloads

 t2 - Drywheyspec.pdf   53.72KB   114 downloads

Different types of ingredient will vary in their specific content and emphasis of course.

Most people draft the input specifications at the beginning of FS project because (a) first step in most flow charts, (b) rather difficult to start the hazard analysis without them.

Rgds / Charles.C

Many thanks Charles. Your support is really very appreciated. Thanks a lot!
In fact, I do have buying criteris for Raw Materials and suppliers do send me SQA and their product descriptions and specifications. However I have not included these in my manual. They are present online. But my auditor gave me a critical Non conformity.
How should I argue?
Pls help
Rudra

[Charles.C]

Dear Rudra,

How should I argue?

I understand you are saying that you are maintaining yr product specification list on-line but no hard copy. I am surprised that this created a critical NC if yr documentation system was viewably controlled as per the standard’s requirements and readily available to relevant users.

Or was the critical NC due to overall assessment including other major NCs ?

I presume this was stage1 of audit similar to this schedule (not a user of iso/fssc22000 myself)? -

http://www.fssint.co...x.php?q=node/43

Rgds / Charles.C

[HPG]

In fact, I do have buying criteris for Raw Materials and suppliers do send me SQA and their product descriptions and specifications. However I have not included these in my manual. They are present online.

Dear Rudra,
Have you state in your manual that you maintain raw material's specifications online and PIC whose always make record about it?
If you already have, then I don't see any reason to give you NC.

Rgds,
Hadi

[Rudra]

Hello,

I have validated my CCP for moisture content in animal feeds with a critical limit of 12% max. This validation is not enough.
Any document from you which cn support this?


rudra

Edited by Charles.C, 05 March 2013 - 04:59 AM.
moved posts 10-12 from other thread

[williamw]

How did you validate the critical limit and why do you say it is not enough?

Without knowing the answer to that I will add that control of moisture is not the key to microbial control, it is the control of water activity. So one approach might be to measure the water activity (given the cost of the equipment you would probably want to have this done by an outside lab) of the product and determine the relationship to the water activity. Once you can show that in a given product a given moisture correlates to a safe water activity you can then use the moisture measurement as a control. However, keep in mind that if you change the product formulation you may change the a_w moisture relationship and have to revalidate the control.

[AS NUR]

dear rudra,

Can you state what is your hazard on your ccp, and what is control measures?..


rgds

AS Nur

[Rudra]

dear rudra,

Can you state what is your hazard on your ccp, and what is control measures?..


rgds

AS Nur

Thanks guys,

Is there any clause in ISO 22000:2005, which says that ingredients of animal feeds should be written on bags?
I have product description sheets mentioning all ingredients we using.
Auditor arguing that its a must to have the ingredients written on bags sent to clients.
Is this a MAJOR NONCONFORMITY.

Regards,
Shakti

[SUSHIL]

Thanks guys,

Is there any clause in ISO 22000:2005, which says that ingredients of animal feeds should be written on bags?
I have product description sheets mentioning all ingredients we using.
Auditor arguing that its a must to have the ingredients written on bags sent to clients.
Is this a MAJOR NONCONFORMITY.

Regards,
Shakti

Hello Rudra,
Labelling is a part of identification of product and traceability exercise of Iso 22000.It should contain information of raw materials/ingredients in products as well as information on shelf life and storage conditions ,Lot no/Batch no and weight . it is also mandatory Regulatory requirements of all countries (For e.g. raw materials as one of the allergens in product on labels, is in fact a ccp).
Raw material/Lot,Batch no of product labels, helps us in traceability exercise,mock recall and actual recalls and return of damaged goods , contaminated goods and expired goods etc.
Also attaching some procedures/documents on emergency preparedness/crisis management ,transportation etc some of these are from IFSQN WEBSITE.

Regards
Sushil

Attached Files

•  FSQM 29 Transportation Procedures.doc   52KB   260 downloads
•  FS -Crisis Management Procedure.docx   15.42KB   414 downloads
•  Procedure_for_Emergency Preparedness.docx   52.56KB   517 downloads
•  PRP 16.3 Despatch and Distribution Prerequisites.pdf   175.44KB   270 downloads
•  QA-011 Weight Checks & Labels Monitoring .doc   30.5KB   239 downloads
•  QA-013 Label Approval Form.doc   22.5KB   227 downloads
•  QA-013 Label Approval Form.doc   22.5KB   184 downloads
•  QA-015 Finished Products Log.doc   34KB   222 downloads
•  QSM_Transportation_Management.pdf   108.92KB   246 downloads
•  Transport Code of Practice.doc   36KB   206 downloads
•  Transportation& Storage Policy.doc   23.5KB   232 downloads
•  Truck inspection report.doc   54.5KB   241 downloads
•  Water activity chart.doc   1.98MB   246 downloads
•  Water activity testing.doc   2MB   228 downloads

[Zeeshan]

I also didn’t understand yr No.4, what para. in the standard was involved ?

This statement belongs to clause 7.3.4 'Intended use'.


Regards.
Muhammad Zeeshan Zaki.

[Rudra]

Sushil,
The attachements you sent me are very very very top!
Thanks a lot,

Rudra

Hello Rudra,
Labelling is a part of identification of product and traceability exercise of Iso 22000.It should contain information of raw materials/ingredients in products as well as information on shelf life and storage conditions ,Lot no/Batch no and weight . it is also mandatory Regulatory requirements of all countries (For e.g. raw materials as one of the allergens in product on labels, is in fact a ccp).
Raw material/Lot,Batch no of product labels, helps us in traceability exercise,mock recall and actual recalls and return of damaged goods , contaminated goods and expired goods etc.
Also attaching some procedures/documents on emergency preparedness/crisis management ,transportation etc some of these are from IFSQN WEBSITE.

Regards
Sushil

[rami hachtouki]

Hi everyone I suggest the attached form that covers all ISO22000 requirements about end product characteristics
a) product name or similar identification; b) composition; c) biological, chemical and physical characteristics relevant for food safety; d) intended shelf life and storage conditions; e) packaging; f) labelling relating to food safety and/or instructions for handling, preparation and intended use; g) method(s) of distribution and delivery.

Dear Rudra,

Regarding my previous post, i noticed your earlier thread contained an attachment of a haccp plan for animal feed -

http://www.ifsqn.com...dpost__p__57856

In that case, the initial input hazard was apparently mycotoxins. There, the control was implemented by (real-time) sampling / analysis of mycotoxin content in ingredients at time of reception. I believe this is a common alternative to using moisture as a CCP but maybe required more analytical expertise than you have available. It does avoid the validation complexities though.

As noted previous post, details of range of possible required characteristics for "Product Specifications" are given in the standard. As examples of some of the possibilities, here are two documents previously posted by Tony-C for an ISO22000 yoghurt thread -

t1 - SkimMilkPowder_spec1.pdf

t2 - Drywheyspec.pdf

Different types of ingredient will vary in their specific content and emphasis of course.

Most people draft the input specifications at the beginning of FS project because (a) first step in most flow charts, (b) rather difficult to start the hazard analysis without them.

Rgds / Charles.C

Attached Files

•  FS-Form-05 End Products Description Form.doc   89KB   56 downloads