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What can be done to demonstrate effective cleaning validation?


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#1 Smitjc1984

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Posted 15 October 2018 - 08:01 AM

Good day everyone

 

My client is in the low risk manufacturing but was asked by the auditor to proof validation of cleaning, she already does swabs, a complete cleaning checklist as well as testing of her chemical strength with QAC strips, any tips on what else can be done to satisfy the auditor?



#2 mohamed ahmed yusuf

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Posted 15 October 2018 - 08:05 AM

Good day everyone

 

My client is in the low risk manufacturing but was asked by the auditor to proof validation of cleaning, she already does swabs, a complete cleaning checklist as well as testing of her chemical strength with QAC strips, any tips on what else can be done to satisfy the auditor?

Hello, 

For this issue i think results of swabs before cleaning and disinfection and after is an evidence for Validation.


M.Yusuf


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#3 012117

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Posted 15 October 2018 - 10:12 AM

Hi, Smitjc.

 

 

What is the objective of cleaning? Is this the manual cleaning or is this CIP to begin with?  Normally, swabs and QAC strips are for "verification".  For the validation, you need first to assess the cleanbility of your line and are the equipment (including auxiliaries - gaskets, etc) are compatible with your cleaning chemicals. Then check historical data if there some issues in the line related to cleaning. Then validate for different cycles (with different personnel or shift) if each shift is doing the procedure as defined or as written.  Took photos of the activity (e.g if the procedure say 3 are required, the shift should be allotted with 3 person every time or if the procedure said to dismantle some parts then it should be what is happening). Check also the cleaning implements if what are needed are all available. Check the training if they are competent and trained to perform the cleaning.  All of these to be documented. 

 

Based on what you observed then you take the swabs and QAC to "verify" its effectiveness.



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#4 Hreddy

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Posted 15 October 2018 - 10:51 AM

Hi Smit,

 

Your already identified its low risk area based on the risk assessment and previous history, 

 

As our IFSQN members mentioned maintaining the verifying records of swab tests after and before cleaning gives confidence to auditors.

 

Secondly conduct the environment sampling data and monitoring records gives good impression to auditors.

 

Also sharing or displaying the cleaning SOP of the particular place or machine its added advantage.

 

Regards

H.reddy



#5 Jean Carmona

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Posted 15 October 2018 - 11:59 AM

Is it swabs the only way to verify cleanliness? or to tell what you are saying you are cleaning it's really clean?

 

I don't do swabbing of any kind and my final audit is in December for sqf lvl 2 for food packaging (we don't handle food) we only manufacture food packaging.



#6 Scampi

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Posted 15 October 2018 - 12:56 PM

The other way to verify (and is included as a method in SQF guidance) is by VISUAL INSPECTION

 

If you have a pre op record and SOP this should suffice

 

From the guidance

11.2.13.5 Pre-operational inspections shall be conducted following cleaning and sanitation operations to ensure
food processing areas, product contact surfaces, equipment, staff amenities and sanitary facilities and other
essential areas are clean before the commencement of production. Pre-operational inspections shall be
conducted by qualified personnel.
 
Evaluation of cleaning. Monitor the effectiveness of cleaning and keep records of all inspections
implemented to verify the effectiveness of the cleaning program
 
To verify the effectiveness of sanitation, a visual pre-operational inspection of equipment and site is to be
conducted prior to the start of operations, after a sanitation activity or the beginning of a shift. For high risk
operations and allergen cleaning verification (refer to 2.8.2.1), a more thorough swabbing program shall be
implemented to verify the integrity of the cleaning regime.
 
Guidance for Developing, Documenting, Implementing,
Maintaining and Auditing an SQF System
SQF Code, Edition 8 – Module 11: Good Manufacturing Practices for Processing of
Food Products
© 2017 Food Marketing Institute 30
SQF Code Module 11 Guidance

 

 

Auditors NEED to start reading the guidance as well


Edited by Scampi, 15 October 2018 - 01:00 PM.

Because we always have is never an appropriate response!


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#7 Jean Carmona

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Posted 15 October 2018 - 02:02 PM

The other way to verify (and is included as a method in SQF guidance) is by VISUAL INSPECTION

 

If you have a pre op record and SOP this should suffice

 

From the guidance

11.2.13.5 Pre-operational inspections shall be conducted following cleaning and sanitation operations to ensure
food processing areas, product contact surfaces, equipment, staff amenities and sanitary facilities and other
essential areas are clean before the commencement of production. Pre-operational inspections shall be
conducted by qualified personnel.
 
Evaluation of cleaning. Monitor the effectiveness of cleaning and keep records of all inspections
implemented to verify the effectiveness of the cleaning program
 
To verify the effectiveness of sanitation, a visual pre-operational inspection of equipment and site is to be
conducted prior to the start of operations, after a sanitation activity or the beginning of a shift. For high risk
operations and allergen cleaning verification (refer to 2.8.2.1), a more thorough swabbing program shall be
implemented to verify the integrity of the cleaning regime.
 
Guidance for Developing, Documenting, Implementing,
Maintaining and Auditing an SQF System
SQF Code, Edition 8 – Module 11: Good Manufacturing Practices for Processing of
Food Products
© 2017 Food Marketing Institute 30
SQF Code Module 11 Guidance

 

 

Auditors NEED to start reading the guidance as well

 

 

Couldn't agree more, sometimes they just wanna keep doing the way that they have been doing without proper follow of the requirements.

 

Thank you Scampi!



#8 Scampi

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Posted 15 October 2018 - 02:28 PM

The auditor I had tried this trick on me too...........but I had prepared by reading the guidance and referring to it during the audit. In order for any of these GFSI's to actually MEAN anything, they need to be applied evenly and equally regardless of location/auditor..


Because we always have is never an appropriate response!


#9 012117

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Posted 15 October 2018 - 03:06 PM

yep but the keyword for the guidance is to "verify" but the OP referred to "validation", unless the guidance pertain to the same thing.. but agree, that above are ways to "verify" effectiveness or after the cleaning. :)



#10 Scampi

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Posted 15 October 2018 - 03:40 PM

From the code

"vi. The responsibility and methods used to verify the effectiveness of the cleaning and sanitation
program."
 
The only mention for VALIDATION in the code is for CIP and that is new for V8
 
SQF has done a horrible job of explaining Verify vs Validate----they have used almost the exact same description and as a result, there are being used interchangeable when they are NOT interchangeable
 
So again, it comes back to what the code says and unless PP is talking about CIP (and I doubt it in low risk) that the cleaning does not require "validation"........even swabbing is not VALIDATION it is verification

Because we always have is never an appropriate response!


#11 Charles.C

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Posted 16 October 2018 - 03:52 AM

Good day everyone

 

My client is in the low risk manufacturing but was asked by the auditor to proof validation of cleaning, she already does swabs, a complete cleaning checklist as well as testing of her chemical strength with QAC strips, any tips on what else can be done to satisfy the auditor?

 

Standard ??

 

Process ??

 

Product ??


Kind Regards,

 

Charles.C





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