7 replies to this topic

[lynzy05]

Hi everyone!

 

I started a new job and was asked to complete an internal audit in preparation for the next BRC audit. I found out that one of the NCs last audit was about CIP Validation. We do have a CIP system going on, they test the pH and stuff but they do not have a validation for this.

 

The operations manager contacted someone he knows to help us validate this however, what I got was basically a word document with just graphs.

 

I am not sure if this is what the auditor is looking for because I have never had to deal with the CIP part of the audit. I have never seen what my old company showed to the auditor.

 

The "validation document" they gave me know is an A4 document with graphs. No company name of the validator, no signature or date etc. Will this be ok as proof that the CIP system is validated?

 

Any help would be highly appreciated. I know my company is doing it right but not sure what to show to the auditor.

 

Thank you in advance

[SQFconsultant]

I would first go back to the audit where the NC was shown and determine within the company what the response was from your company to close it out.

 

There had to be a response that was accepted by the Auditor or other at the CB.

[lynzy05]

I would first go back to the audit where the NC was shown and determine within the company what the response was from your company to close it out.

 

There had to be a response that was accepted by the Auditor or other at the CB.

 

Hi. I did check it and the QA Manager used the email thread of "We have scheduled to check and validate your CIP" email as her response and for some reason it got accepted.

 

I know they will definitely look at it in the next audit so I want to make sure we have the correct one. I asked the QA Manager but she seems to be unsure as well... 

[Tony-C]

Hi lynzy05,

 

This falls under BRCGS Global Standard for Food Safety Issue 9 Section 4.11.7 Cleaning in place (CIP) and in particular Clause 4.11.7.1. Unless you have the skill in-house then this is something that should be carried out by the equipment manufacturer or a specialist contractor. In an ideal world this would have been already done at the commissioning stage.

 

Here are some extracts from the guidance offered by BRCGS which makes it clearer what validation evidence is required:

 

The site will therefore need validation to confirm that the design, set-up and proposed operation of the system are suitable for the intended use. For example:

• knowledge of the layout of the pipework and the position of valves, spray balls and holding tanks is essential to ensure that the system will operate consistently and effectively and that there are no dead spots or areas where cross-contamination between cleaning chemicals and product can occur

• correct design of the CIP system to ensure good coverage of cleaning solutions with suitable drainage to avoid pools of solutions; for example, the prevention of shadows caused by baffles or spray balls that have been incorrectly located

• assurance that the intended cleaning will be effective (e.g. that the food/products intended to be used on the equipment will be effectively removed during cleaning)

• consideration of the risk of potential contaminants (e.g. allergens) from previous products being re-introduced onto the equipment during the collection, recycling or re-use of solutions (e.g. rinse solutions).

 

Confirmation of the correct design and set-up may be achieved by an inspection report (e.g. from the equipment manufacturer) or by separate documented validation.

A schematic plan or diagram should be provided by the supplier when the system is installed and must be updated whenever a change is made, including to software, equipment and operation of the system.

 

Also note that validation is required in Section 5.3 Management of allergens – Clause 5.3.8 Allergen cleaning

 

Kind regards,

 

Tony

[lynzy05]

Hi lynzy05,

 

This falls under BRCGS Global Standard for Food Safety Issue 9 Section 4.11.7 Cleaning in place (CIP) and in particular Clause 4.11.7.1. Unless you have the skill in-house then this is something that should be carried out by the equipment manufacturer or a specialist contractor. In an ideal world this would have been already done at the commissioning stage.

 

Here are some extracts from the guidance offered by BRCGS which makes it clearer what validation evidence is required:

 

The site will therefore need validation to confirm that the design, set-up and proposed operation of the system are suitable for the intended use. For example:

• knowledge of the layout of the pipework and the position of valves, spray balls and holding tanks is essential to ensure that the system will operate consistently and effectively and that there are no dead spots or areas where cross-contamination between cleaning chemicals and product can occur

• correct design of the CIP system to ensure good coverage of cleaning solutions with suitable drainage to avoid pools of solutions; for example, the prevention of shadows caused by baffles or spray balls that have been incorrectly located

• assurance that the intended cleaning will be effective (e.g. that the food/products intended to be used on the equipment will be effectively removed during cleaning)

• consideration of the risk of potential contaminants (e.g. allergens) from previous products being re-introduced onto the equipment during the collection, recycling or re-use of solutions (e.g. rinse solutions).

 

Confirmation of the correct design and set-up may be achieved by an inspection report (e.g. from the equipment manufacturer) or by separate documented validation.

A schematic plan or diagram should be provided by the supplier when the system is installed and must be updated whenever a change is made, including to software, equipment and operation of the system.

 

Also note that validation is required in Section 5.3 Management of allergens – Clause 5.3.8 Allergen cleaning

 

Kind regards,

 

Tony

 

 

Hi Tony 

 

Thanks for this. I did see it as well and thought the one I have will not be enough.

 

Talking to the operations manager, seems like the company did get the diagram and data etc during installation but was never validated because of extra cost. They werent aiming to get a BRC certificate 5 years ago, only just last year thats why they never thought of getting it validated... tsk tsk tsk...

 

Looks like the one I have needs more work.

[Tony-C]

Hi Tony 

 

Thanks for this. I did see it as well and thought the one I have will not be enough.

 

Talking to the operations manager, seems like the company did get the diagram and data etc during installation but was never validated because of extra cost. They werent aiming to get a BRC certificate 5 years ago, only just last year thats why they never thought of getting it validated... tsk tsk tsk...

 

Looks like the one I have needs more work.

 

Hi lynzy05,

 

It will be good if the company are happy to invest that extra cost now. IME the validation will be an eye opener for sure if done properly.

 

 

Kind regards,

 

Tony

[AJL]

Sometimes your chemical supplier will have consultants that can will 'validate' your CIP process. 

Important checks are: temp, flow rate, time, check of no 'dead ends' check that the chemical is appropriate and the right concentration, etc and so on. 

The chemical used and concentration, time, temp etc will be specific for YOUR process, which is why every CIP system needs a validation.

If you can use your CIP system supplier, even better. This is WORTH the cost. Poor cleaning will cost you in recalls in the long run  

 

Once it has been validated you need to make sure it is revalidated yearly. You should also verify regularly based on risk. 

This could include:

• Finished product testing for allergens/indicator bacteria
• Swabs/rinse water tests - could be LFD or ATP 
• Visual inspections

[Tony-C]

 

Sometimes your chemical supplier will have consultants that can will 'validate' your CIP process. 

Important checks are: temp, flow rate, time, check of no 'dead ends' check that the chemical is appropriate and the right concentration, etc and so on. 

The chemical used and concentration, time, temp etc will be specific for YOUR process, which is why every CIP system needs a validation.

If you can use your CIP system supplier, even better. This is WORTH the cost. Poor cleaning will cost you in recalls in the long run

 

Once it has been validated you need to make sure it is revalidated yearly. You should also verify regularly based on risk. 

This could include:

• Finished product testing for allergens/indicator bacteria
• Swabs/rinse water tests - could be LFD or ATP 
• Visual inspections

 

 

That is a good idea AJL, especially if your chemical supplier is a major player in the market as they are likely have that resource or access to it.

 

Kind regards,

 

Tony