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Microbiological sampling plan for QA monitoring

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danieljoshua.tayamora

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Posted 30 June 2016 - 04:24 AM

Good day Everyone!

 

May I ask for your opinions on the ideal sampling plan for microbiological testing of in-line products for monitoring product quality and safety?

 

The current sampling plan we are using is composite sampling of 5 individual packs obtained from one batch of production performed on a monthly basis. 

 

Is this sufficient enough as a validation process for product safety and quality? or should we implement a more stringent testing procedure?

 

Looking forward to your valuable insights.

 

Many thanks,

 

Dan



Charles.C

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Posted 30 June 2016 - 05:45 AM

Good day Everyone!

 

May I ask for your opinions on the ideal sampling plan for microbiological testing of in-line products for monitoring product quality and safety?

 

The current sampling plan we are using is composite sampling of 5 individual packs obtained from one batch of production performed on a monthly basis. 

 

Is this sufficient enough as a validation process for product safety and quality? or should we implement a more stringent testing procedure?

 

Looking forward to your valuable insights.

 

Many thanks,

 

Dan

 

Hi Dan,

 

An answer will require data.

 

A meaningful answer may relate to risk factors such as -

(1) the product / its description.

(2) the process involved.

(3) any local/destination regulatory micro.requirements regarding Q/S

(4) any contractual micro.requirements regarding Q/S

(5) micro.history of product regarding Q/S


Kind Regards,

 

Charles.C


danieljoshua.tayamora

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Posted 01 July 2016 - 09:59 AM

Hi Dan,

 

An answer will require data.

 

A meaningful answer may relate to risk factors such as -

(1) the product / its description.

(2) the process involved.

(3) any local/destination regulatory micro.requirements regarding Q/S

(4) any contractual micro.requirements regarding Q/S

(5) micro.history of product regarding Q/S

 

Hi Charles!

 

Thank you for pointing these out. Here are some of the data that I can provide as of the moment:

 

1.) Raw, minimally processed meat (marinate and seasoning are the only process involved prior to frozen storage)

2.) From carcass meat it will undergo cutting and slicing, tumbling, marinate, blast freeze, store

3 & 4.) As for micro-requirements, this is what I am uncertain. So far, our testing scheme involves just what was mentioned above and conducted in-house

5.) as for the history, this data is not yet available to me

 

Thank you and really appreciate all help as I would be starting from scratch. XD 

 

Best regards,

 

Dan



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Charles.C

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Posted 01 July 2016 - 12:30 PM

Hi Dan,

 

I assume by "raw" you are referring to the finished product, ie NRTE.

Beef meat not my area of expertise but I anticipate that a Product Specification / Flowchart will be useful for posters to make meaningful suggestions.

Regarding yr OP, a comment likely relates to what you are specifically sampling for.? and what the results / trends are like.

 

Not sure what level of technical support is currently available to you but text atttached offers some insights into likely hazards / sampling procedures for (a) finished product/Raw material, (b) environment from a USDA POV. The latter may be less relevant to a purely NRTE finished product. Line sampling seems not utlilised although perhaps would be if finished product specifications not met. I normally (but different product mix) focus on initial bacterial levels as compared to final when checking a raw process. Particularly at potential delay stages.

 

One (product) sampling scheme (N60) mentioned in the text is also attached.  This appears a highly intensive scheme and illustrates the statistical difficulty in efficiently detecting pathogens prevalent at low levels. I daresay not readily implemented for some locations. Options using smaller sample sizes do exist if less demanding  probability requirements are acceptable.

 

Attached File  USDA Introduction to Microbiology of Food processing,2012.pdf   2.32MB   243 downloads
Attached File  FSIS 10010.1,Rev4,2015.pdf   4MB   221 downloads

 

Hope this helps.


Kind Regards,

 

Charles.C


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ebell

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Posted 01 July 2016 - 03:19 PM

Dan-

 

We do similar things and since we are an USDA inspected site, we follow those regulations. However, our marinated product is NOT vacuum tumbled and therefore it is an intact product. If it were vacuum tumbled, it would be included in our robust test and hold program where samples are taken every 15 minutes, composited in 2 hour lots, and tested for E. coli O157:H7.

 

Do you test the incoming material for any microorganisms?

 

Hope this helps a little.

 

Erin



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Charles.C

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Posted 01 July 2016 - 06:32 PM

Hi Dan,

 

If you don't mind doing a little back-tracking/reading, some summaries/attachments explaining the development of sampling plans are sub-linked / sub-sub-linked from this thread -

 

http://www.ifsqn.com...-sampling-plan/

 

There are at least 3 types of sampling plans commonly used with micro.variables  -

 

(1) Plans which are basically intended for accept/reject decisions, eg nmMc Plans for specific pathogens like Salmonella or general characteristics such as Plate Count. Also AQL-type plans.

 

(2) Plans which are firstly intended to estimate the average value of a specific lot characteristic and perhaps secondly allow an accept/reject decision. These are based on formulae/statistical distributions linking factors such as standard deviation, desired accuracy of estimate /confidence level.

 

(3) Plans designed to enable the detection of (or imply the absence of) the presence of pathogens such as Salmonella with a known probability/confidence level.


Kind Regards,

 

Charles.C


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danieljoshua.tayamora

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Posted 05 July 2016 - 01:13 AM

Hello Charles and Erin! 

 

Thank you so much for all your inputs. I skimmed thru some of the attachments you referred and these were all very helpful. As I am still waiting for the inputs of our QA dept. (I'm from R&D), I do not yet have full info on how they conduct sampling. I just want to equip myself with knowledge of the ideal sampling plan that is applicable to our company before we meet. I am

 

Nevertheless, these are all very good materials to begin with, and will be reviewing them thoroughly.

 

Thank you once again and God bless you all! :)





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