8 replies to this topic

[esperanza.vivas1983]

Hello everyone, I need your guidance, in a recent audit the auditor has asked me to justify how I perform the validation of cleanliness in the packaging area (Our company is only dedicated to the repackaging of processed foods). 

My explanation is that our procedures are:

- Using an ATP once a week on all contact surfaces and monthly for non-contact surfaces.

- Microbiological test (Enterobacteria test) once a year on all surfaces.

 

The question that the auditor asked me and that I could not justify is how to validate these times? scientific basis.

We have records for two years, and  have never had any deviation.

 

I am very confused.

 

I appreciate your input.

 

[olenazh]

Hello, welcome to the forum. Hope, the attached would give you some idea. 

Attached Files

•  Chemical Effectiveness Validation_SAMPLE.xls   29KB   129 downloads

[Scampi]

How did you determine your ATP parameters for clean enough

 

Do you perform a full wet clean daily?  If so, why did you chose weekly for ATP?

 

If the auditor asked specifically about VALIDATION, they are looking for a report that explains WHY you do your checks at the frequencies you do, not just what you do 

[esperanza.vivas1983]

At the beginning, ATP was performed daily and, after a year, as the results were always satisfactory, it was decided to perform it once a week.

we use the chemicals recommended by Cintas supplier for food contact surfaces and Non Contact Surface.  Follow the cleaning and sanitization schedule.

[Scampi]

So you do not have a summary of the sanitation process and testing that would work as a validation?

[esperanza.vivas1983]

Yes, we have the cleaning and sanitation procedure and records for the last two years, but this is not sufficient for the auditor. 

He wants to know how each week's decision was made for the ATP and Microbiological Test annually

[olenazh]

Yes, we have the cleaning and sanitation procedure and records for the last two years, but this is not sufficient for the auditor. 

He wants to know how each week's decision was made for the ATP and Microbiological Test annually

I don't think you need a scientific base for your decision as it's based on your historical data of testing results. Just write a document explaining your decision: no negative swabbing results for the 2-year period, no customer complaints concerning the matter, chemicals are used at correct concentration, no deviations regarding cleaning/sanitation, no negative observations during pre-ops, correlate your decision to your GFSI scheme and/or regulatory requirements, etc., etc. Pour more water into your barrel:) 

[Charles.C]

 

Hello everyone, I need your guidance, in a recent audit the auditor has asked me to justify how I perform the validation of cleanliness in the packaging area (Our company is only dedicated to the repackaging of processed foods). 

My explanation is that our procedures are:

- Using an ATP once a week on all contact surfaces and monthly for non-contact surfaces.

- Microbiological test (Enterobacteria test) once a year on all surfaces.

 

The question that the auditor asked me and that I could not justify is how to validate these times? scientific basis.

We have records for two years, and  have never had any deviation.

 

I am very confused.

 

I appreciate your input.

 

Hi esperanza,

 

What is the Standard which you are being audited for ? Local standard, BRC, SQF etc ?

 

(Sounds like a BRC risk assessment query.)

[Ryan M.]

What you basically did was verify your sanitation, and not validate. To validate your need to do swabbing and micro testing of equipment and materials pre-sanitation and then again post-sanitation.

You should see ATP pre-sanitation of course and that will be your baseline. Passing of ATP (whatever limits you set) will show the cleaning is effective and thus validated. Same with the the micro results.

Further atp and micro tests in a set frequency serve as verification.

You should re-validate anytime there is a change to cleaning procedures, cleaning supplies, and/or equipment.