Verification of Allergen Cleanings
What needs to be documented (or conversely, does not need to be documented) in terms of allergen cleaning verification per SQF? Note: the cleaning procedure is already VALIDATED so I'm strictly wondering about the verification. Does there need to be some sort of document every time there is a changeover, or can a verification happen on a set schedule such as once per month or quarter by myself (Quality Assurance)?
For example, we may have a changeover on a line 4 times per day between allergens. Do I or a trained designee need to inspect and document the cleaning of this line every time and/or do swabs OR can the lead person in the area just visually verify it's clean before running the next product? We are a small plant so we need the flexibility of running different products whenever a customer needs them and often times running allergens at the end of the week or grouped together isn't feasible.
I'm curious to hear how people handle the verification portion of allergen cleaning.
Thanks!
Do I or a trained designee need to inspect and document the cleaning of this line every time and/or do swabs OR can the lead person in the area just visually verify it's clean before running the next product?
I'm curious to hear how people handle the verification portion of allergen cleaning.
Thanks!
Is there a reason the lead person in the area can not be the trained designee (Like if your Sanitation Dept cleans, the Sanitation Lead shouldn't be inspecting)?
Verification here includes documenting the clean & a visual inspection per run. If I'm reviewing the batch sheets and cleaning isn't documented product goes on hold. Otherwise the one-time validation of the clean out is only allergen testing we do, with one exception. We run gluten lateral flow tests before products that have the "gluten free" claim on them, or if a customer requests such testing be conducted per lot.
What needs to be documented (or conversely, does not need to be documented) in terms of allergen cleaning verification per SQF? Note: the cleaning procedure is already VALIDATED so I'm strictly wondering about the verification. Does there need to be some sort of document every time there is a changeover, or can a verification happen on a set schedule such as once per month or quarter by myself (Quality Assurance)?
For example, we may have a changeover on a line 4 times per day between allergens. Do I or a trained designee need to inspect and document the cleaning of this line every time and/or do swabs OR can the lead person in the area just visually verify it's clean before running the next product? We are a small plant so we need the flexibility of running different products whenever a customer needs them and often times running allergens at the end of the week or grouped together isn't feasible.
I'm curious to hear how people handle the verification portion of allergen cleaning.
Thanks!
A verification can be done on a batch sheet. Add a column or row that states QA verification or Sanitation verification of cleaning: Visual (Pass/Fail) and Protein Swab Test (Pass/Fail). Lead person, if production, is too much of a conflict of interest because that person will only want to continue to process to get to go home on time. Or you can make a separate sheet that shows the time of cleaning who cleaned and who inspected using which method. Honestly, I would prefer some sort of evidence in chronological order in which your products were run like a batch sheet for traceability purposes in case something does go awry you have physical evidence in place in real time. Allergens are a big issue, so I would go with verification after every changeover. You can't identically clean pieces of equipment so once per month and quarter does not work here. If you are running different allergens on the same line with changeovers, make sure your label states something like "This product is run on shared equipment with allergens A,B,C"
Verification can be done on the basis of defined frequency starting from batch and after collecting sufficient data, Allergen testing frequency can be reduced.
Thanks for all the input! Unfortunately we are a very small company. Each department only has between 3 and 10 people in it, and I am the only QA representative. This creates the challenge of trying to ensure there are no conflicts of interest quite difficult. Also, our kitchen area starts very early in the morning before anyone else is here and they may need to do a changeover before I even arrive. We do not have a sanitation group, and because of this production cleans all their own equipment.
It sounds like I will have to have the departments fill out yet more wonderful paper work each time a changeover is completed and inspected. Hopefully this will suffice for an auditor!
SQF Terms: Monitor = Person A who does the checking, testing, or in your case, the person cleaning.
Verify = Person B who confirms that the check, test or other procedure is being done. Same as Nafar mentioned, you may not need to verify every instance depending on the how quickly you need to detect noncompliance/nonconformance.
Validate = Management review trend analysis to make sure the procedure is controlling what it is suppose to control.