2 replies to this topic

[selmaassili]

hey everyone , 

i'm so thankful for all of you for the help,

actually i didn't understand the new clause about environmental monitoring, could someone explain to me what is the new about this clause 

 

thank you all alot 

[mgourley]

Basically, the new clause requires that risk based environmental monitoring programs be in place for pathogen and/or spoilage organisms. The Standard requires that at a minimum, all production areas with open and RTE products be included.

 

As I read it:

4.11.8.1 - You have to have a documented Environmental Monitoring Program that includes the minimum requirements of this clause.

4.11.8.2 - You have to set control limits for the pathogens/spoilage organisms. You then need to document corrective actions if those control limits fail or when an upward trend in positive results occur.

4.11.8.3 - You have to review the documented program at least annually and when any of the bullet points apply.

 

If you are already doing environmental testing, you are probably already doing these things. The clause simply codifies in one place the requirements that were in other places in Issue 7 and adds more specificity as to what is required.

 

Marshall

[012117]

Selmaasili,

 

In simple terms, enviornmental monitoring program serves to demonstrate that your PRP is able to effectively control microbial cross contamination within your facility. The microbial test that you made must be analagous to the product that you manufactured and the prioritization must be also analog to your process flow.

 

For example.

 

If your product (product A) and process will support growth for Listeria. Then focus must be on Listeria spp or Listeria monocytogenes instead of Salmonella or coliform or EB.

In other example, you have shoe change to separate wet side from dry side, then you will sample the dry side for micro or pathogen of interest more frequently to demonstrate that your system is effective.

 

Then you set limit which is also analog to your product to which you will take action when it exceeds the limit or your trends shows you that you are about to reach the limit.

 

You can use this link from previous discussion.

https://www.ifsqn.co...toring-example/

Or this from FDA, while focusing on listeria, you may find some useful insight for your interest.

 

 

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