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#1 LoredanaM

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Posted 24 December 2014 - 03:26 PM

I am trying to figure out the best way to use proper documents with proper information.There was a Pre-Operational checklist created before I joined the QA department, and since then many updates have been made, but it seems like some data should/shouldn't be on the list.

 

One employee (supervisor) that is filing the form in the morning prior to any other employees even coming into the plant, pointed out that the GMP's part in regards to employees should not be included in the Pre-Op. How he can say it is acceptable that "Employees do not show signs of medical problems" when employees are not even there ... So, I am thinking of removing anything that relates to employees, and leave that information for the Daily Sanitation Inspection that has to be filled out at Production Star-time, and then every 4 hours and even at Post-Op. 

 

Note: there is a time gap between pre-op and start-time, sometimes even 2-3 hours. 

 

Your thoughts? 



#2 That Guy

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Posted 24 December 2014 - 04:27 PM

If the pre-op is sometimes conducted 2-3 hours before start up, what controls are in place to ensure that the conditions recorded on the pre-op have not changed during time prior to processing start up?

 

It really depends exactly what items are being checked on your Pre-Operational checklist, but you may need two separate checklists/inspections to be conducted. Something like personnel GMP's will need to be conducted while employees are present. I would think that sanitary conditions should be checked shortly before processing activities begin, not 2-3 hours before, but it depends on your operations, controls and certification standard.


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#3 LoredanaM

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Posted 24 December 2014 - 05:01 PM

The process as is for now looks more like the pre-op is done when the door of the plant is open for first time of the day - every single area is checked; if there are any issues observed/identified they are taken care right away, thus not taking away from production run. I actually have two separate forms (surely not making my supervisors happy), and the sanitation form does cover all before, during and after production run. 

 

Thank you for your comment, as you just made a great suggestion. I am going to change the Pre-Operational Checklist to be done not at the start of the day, but just prior to production run; and use the sanitation form as inspection form upon turning the lights on for a "new working day". 



#4 RG3

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Posted 24 December 2014 - 05:41 PM

Pre-ops is best done before production starts and preferably while sanitation is there to correct any areas that still need to be cleaned, after all you need a trained employee to handle the chemicals and understand how to clean a particular piece of equipment. The GMP portion when the form was created may have not of been for the production employees but for the sanitors. However, if there are no sanitation employees at the time of pre-op, I agree the portion of GMP's should be taken out, be self standing as a GMP daily Audit performed by QA while production is running. Pre-ops should focus on house-keeping and cleanliness of the equipment and the facility, however sometimes the sanitation crew think they're alone and don't follow GMP's (You'll be surprised with what you find in their carts or in their mouths [gum]).



#5 supadill

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Posted 20 January 2019 - 07:01 PM

Hello all,

I'm just wondering if the Pre-Op can be checked after Sanitation. For instance, our facility is one shift and sanitation ends around 4 pm and the shift start at 7 am.

I'm looking forward to your responses.

 

Thanks,

 

Suyapa



#6 Scampi

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Posted 21 January 2019 - 01:52 PM

Pre op= pre operational inspection and is ALWAYS done between sanitation completing the tasks and manufacturing beginning. Depending on your product/process, you may want PreOp done while someone from sanitation is still there in case something needs recleaned.

 

At PP sanitation was done around 12am and preop started at 7. Some facilities need time to dry prior to the shift beginning.......oh and sanitizer cannot be in puddles..............most are approved for incidental food contact only


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#7 SQFconsultant

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Posted 21 January 2019 - 07:12 PM

No.

Too much time between post sanitation and start time.

All sorts of things can happen in that time frame.


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Glenn Oster
 
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#8 supadill

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Posted 22 January 2019 - 12:24 PM

Thank you!



#9 QA_123

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Posted 22 January 2019 - 04:54 PM

Our sanitation happens on 2nd shift.  Sanitation fills out a post-op form after they are done  The supervisor on the shift that starts the lines up fills out the pre-op form right before production starts.   






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