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Changeover and documentation procedures requirements

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tyvaz

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Posted 28 December 2023 - 04:28 PM

I recently took over QA in a non-24/7 fully-RTE facility. We're regulated by both FDA and USDA. I'm a bit unclear on the regulatory requirements for changeover verifications and documentation. Our current in-process SSOP:  

 

Changeovers are cleaning + sanitizing of all equipment, and verifications are done by visual checks only, no ATP (although we require pre-sanitizer ATP checks for our overnight sanitation crew). The inspections are comprehensive, and QA is well-experienced in them (there is no formal training on file regarding changeover procedures/verifications, which is on my fix-list). The only place these inspections get documented is a simple check off box on their CCP/process verifications form. 

 

I've never worked anyplace that did not a) verify cleaning by ATP and b) comprehensively document their cleanup verifications. However, I'm an advocate for keeping things simple, so if we're compliant as is, without ATP checks for changeovers and with the "check box" for documentation, I'll roll with it. Otherwise I want to straighten it out early on. Looking for feedback and general compliance insight. 

 



kingstudruler1

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Posted 28 December 2023 - 05:01 PM

Here are my thoughts.  

 

1,  if you are  really recent, id make sure you understand the process and why they do things the way they do.  

2.  I would tend to agree that ATP should be used. .With that said, the FDA does not require ATP for verification.    I'm not sure what you are asking about vs overnight sanitation check.   What is only being visual inspected?

3.  i dont have a problem with the check boxes (visually clean - yes or no, or passes  ATP - yes or no) as long as its the person doing the work when the work was done.   


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tyvaz

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Posted 28 December 2023 - 05:22 PM

Thanks for the feedback! Sorry for not being clearer. Overnight sanitation does ATP checks, but for changeover sanitation there are no ATP checks/it's all visual passes, both zone 1 and zone 2 sites. As for documentation, there is one single check off box "the line has been cleaned & inspected" for the entire changeover cleanup, rather than individual check offs for each different piece of equipment being cleaned, which is what I'm accustomed to. It is initialed by the inspector. Thanks.

 

Here are my thoughts.  

 

1,  if you are  really recent, id make sure you understand the process and why they do things the way they do.  

2.  I would tend to agree that ATP should be used. .With that said, the FDA does not require ATP for verification.    I'm not sure what you are asking about vs overnight sanitation check.   What is only being visual inspected?

3.  i dont have a problem with the check boxes (visually clean - yes or no, or passes  ATP - yes or no) as long as its the person doing the work when the work was done.   

 

 SSOP:  

 

Changeovers are cleaning + sanitizing of all equipment, and verifications are done by visual checks only, no ATP (although we require pre-sanitizer ATP checks for our overnight sanitation crew). The inspections are comprehensive, and QA is well-experienced in them (there is no formal training on file regarding changeover procedures/verifications, which is on my fix-list). The only place these inspections get documented is a simple check off box on their CCP/process verifications form. 

 

I've never worked anyplace that did not a) verify cleaning by ATP and b) comprehensively document their cleanup verifications. However, I'm an advocate for keeping things simple, so if we're compliant as is, without ATP checks for changeovers and with the "check box" for documentation, I'll roll with it. Otherwise I want to straighten it out early on. Looking for feedback and general compliance insight. 



G M

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Posted 28 December 2023 - 08:46 PM

I would start by saying your inspection is probably not visual only, but is an organoleptic inspection that incorporates other senses such as touch and smell as well.  A minor distinction perhaps, but one that a pedantic inspector or auditor might jab you with.

 

Not using ATP for every changeover or wash doesn't seem that unusual, it's just a broad verification that your wash procedure is generally effective.

 

How you document that a wash procedure and inspection were conducted is open to some interpretation, so I can see how a simple yes/no checkbox could have been adequate.  Generally speaking the more detailed you make your written program, the more you paint yourself into a corner and force more criteria to be met before it is deemed acceptable.  Looking at programs and procedures over time a lot of the additions can be the result of corrective actions -- for example, we had bad micros in finished goods and concluded it was because X wasn't happening consistently during the wash procedure, so now our changeover has two checkboxes with the first one confirming that X was done.  A lack of sanitation related problems historically could have allowed the documentation to remain quite simple.





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