11 replies to this topic

[Tresa]

Hi everyone, can anyone helps on how to conduct the risk analysis for these clause requirements for food manufacturing? 11.1.2.5 Ducting, conduit, and pipes that convey ingredients, products, or services, such as steam or water, shall be designed and constructed to prevent the contamination of food, ingredients, and food contact surfaces and allow ease of cleaning. A risk analysis shall be conducted to ensure food contamination risks are mitigated. 11.1.2.6 Pipes carrying sanitary waste or wastewater that are located directly over product lines or storage areas shall be designed and constructed to prevent the contamination of food, materials, ingredients, and food contact surfaces and shall allow ease of cleaning. A risk analysis shall be conducted to ensure food contamination risks are mitigated.

[Charles.C]

 

Hi everyone,

 

can anyone helps on how to conduct the risk analysis for these clause requirements for food manufacturing?

 

11.1.2.5 Ducting, conduit, and pipes that convey ingredients, products, or services, such as steam or water, shall be designed and constructed to prevent the contamination of food, ingredients, and food contact surfaces and allow ease of cleaning.

A risk analysis shall be conducted to ensure food contamination risks are mitigated.

 

11.1.2.6 Pipes carrying sanitary waste or wastewater that are located directly over product lines or storage areas shall be designed and constructed to prevent the contamination of food, materials, ingredients, and food contact surfaces and shall allow ease of cleaning.

A risk analysis shall be conducted to ensure food contamination risks are mitigated.

 

 

Hi Tresa,

 

This is SQF becoming a PITA as they borrow  a nuisance feature pioneered by BRC which IMO is a superfluous request as individually featured..

 

if you do a search SQF now has approximately 5-10  clauses of equivalent  style (ie RA of GMP items).

 

I assume that an appropriately implemented GMP program will assure that all these repetitive clauses will actually pose a Low Risk.

 

IMO the semi-generic pdfs in Posts 1, 2  of this thread will handle all these abstractions by introducing the word "frequency" as illustrated -

 

https://www.ifsqn.co...nts/#entry58503

(the suitability is further discussed in Posts 3 et seq)

[SQFconsultant]

First of all, is any of that present in your facility?

[Tresa]

First of all, is any of that present in your facility?

Yes, The pipes carrying the sanitary water are present above an equipment. The pipes are designed to allow ease of cleaning and constructed to prevent the contamination of the product and the food contact surfaces resulting in product safety, but not sure how to complete a risk analysis.

[Tresa]

First of all, is any of that present in your facility?

OR, The flexible conduits are washed/ cleaned to prevent any cross-contamination in the production. The cleaning is done according to the frequency.

[Mulan1010]

Hi Tresa - I can not say if it is right or wrong as we have not been audited on it yet but for...

   11.1.2.5 we basically listed out the ducting, conduit and piping used through out our facility.  We then stated the materials that they were made of.  Fortunately most of it is Stainless Steel although we do have some PVC and Flex Hosing.  For the PVC and Flex Hosing we have their specifications on file stating they are food grade and made that statement in our risk assessment.   We then stated that all the items are inspected on a regular basis and if become loose, damaged or compromised in a way that could affect product safety then they are repaired, cleaned and/or replaced.  For the piping or hoses that carry product from one area to another during production we break them apart nightly and clean so they are addressed daily on pre-op inspections.  For the ducting, conduit, water, steam and compressed air piping we have work orders for them to be inspected periodically and our staff is to be on the look out as well.  We do have documentation where issues with such items have been addressed, as needed.  We also run periodic micro tests on our water, compressed air, equipment surfaces and environment and used that as support that the procedures we have in place are being verified and based on the results the materials used and procedures in place are effective in protecting and maintaining the safety of our products.

  11.1.2.6 - We made a statement that none of our pipes carrying sanitary waste or wastewater are located above, they all run along or under the floor in our facility and we have procedures in place should there be a clogged drain or the drain backs up.  We are fortunate to only have a one level facility for our production areas so this one was not an issue for us. 

[Tresa]

Hi Tresa - I can not say if it is right or wrong as we have not been audited on it yet but for...

   11.1.2.5 we basically listed out the ducting, conduit and piping used through out our facility.  We then stated the materials that they were made of.  Fortunately most of it is Stainless Steel although we do have some PVC and Flex Hosing.  For the PVC and Flex Hosing we have their specifications on file stating they are food grade and made that statement in our risk assessment.   We then stated that all the items are inspected on a regular basis and if become loose, damaged or compromised in a way that could affect product safety then they are repaired, cleaned and/or replaced.  For the piping or hoses that carry product from one area to another during production we break them apart nightly and clean so they are addressed daily on pre-op inspections.  For the ducting, conduit, water, steam and compressed air piping we have work orders for them to be inspected periodically and our staff is to be on the look out as well.  We do have documentation where issues with such items have been addressed, as needed.  We also run periodic micro tests on our water, compressed air, equipment surfaces and environment and used that as support that the procedures we have in place are being verified and based on the results the materials used and procedures in place are effective in protecting and maintaining the safety of our products.

  11.1.2.6 - We made a statement that none of our pipes carrying sanitary waste or wastewater are located above, they all run along or under the floor in our facility and we have procedures in place should there be a clogged drain or the drain backs up.  We are fortunate to only have a one level facility for our production areas so this one was not an issue for us. 

Hi Mulan, Thank you for your input. are you able to share your RA?

[PQAManager]

Risk Description:

Date:

Scope:

Assessment:

Control Step:

[KMC]

Is there a template for the RA of pipes carrying sanitary waste or wastewater that are located directly over product lines or storage areas? 

[yoelastorga]

Hi Tresa, 

Can you find the way to resolve the risk assesment for ducting, conducts and pipes?

[TylerJones]

We have recently had a pre-assessment for 9.0 and our auditor would not leave our refrigeration units alone regarding this clause. The evaporators have a few pipes, one carrying freon and another for the drain when they go into defrost mode. These are clearly in the worst possible location in my old building -directly over packaging machines with open product. I risk assesed them using historical data on maintenance issues to include overhead pipe failures, showing zero. I have also made them a monthly PM procedure to be inspected / repaired if needed and I also added them to the pre-op inspection. Once the audior saw that he left me alone and moved on. So basically in this plant all overhead pipes are inspected through the maintenance program on a monthly frequency and any over machines / product I added to daily pre-op. I feel that my frequency is overkill, but felt this was more of a check in the box for SQF (there are a few more elements that I feel are like this as well). 

[Kara S.]

I would just do a general overhead risk assessment - if it is above open product (no shields to protect the product) then your risk is high. Something is capable of falling into the product stream because it is open to environment. You may want to have a daily check for overheads, calling out specific items so your employees understand what to look out for if you think any of the overhead elements could potentially cause an issue. 

• Leaking pipes
• Peeling paint
• excessive dust
• damaged lights