Documents & Records for 24 hr production

One of our production lines is moving to running continuously from Sunday night to Thursday afternoon. Currently every day we are doing a pre-op inspection for sanitation, plus all weight checks, lot numbers, sanitation sign off, overrun product, product from last run, etc.

Since production will be running from Sunday night until Thursday a thorough pre-op will not be completed each day, nor will a complete clean up be performed until the end of the week.

 

Certainly some has experienced this type of change. How did your operational paperwork change? Did it change to match your production reporting?

 

Dear P&S -

     Can you tell us what regulatory oversight you have - FDA, FSIS, Health Dept, etc. That will drive the direction of a lot of your changes.

 

     Several US FSIS inspected further processing companies are moving or have moved to Less Than Daily (LTD) cleaning. All of my plants are under LTD, so I can provide some degree of guidance in that direction for FSIS compliance.

This particular area is under FDA. However, we do have USDA FSIS in the facility.

Dear P&S -

     I have not been under FDA in so long, and with the FMSA changes, not sure I could help a lot. There are some differences between FDA & FSIS, but there is a wealth of info on the FSIS website. Search by 'Less Than Daily Cleaning' or 'Extended Run'. If you can't find what you need, let me know and I can start uploading documents.

 

     In fact, I think I have done so in the recent past - not sure if this forum or another. I am not sure how you search for associated threads. MODERATOR - Can you help here?

Regardless of a 24 hour production site, you can still undertake and record pre-operational checks. The purpose of a pre-operational check is to check that the environment is safe / tidy / clean, there is no potential sources of contamination and staff are following good hygiene practices. It can also be used as the time to calibrate manual scales that may be used for product weight checks through out the shift. Just set a particular time of the day (for example 7am) to do the check and complete to the record.

One of our production lines is moving to running continuously from Sunday night to Thursday afternoon. Currently every day we are doing a pre-op inspection for sanitation, plus all weight checks, lot numbers, sanitation sign off, overrun product, product from last run, etc.

Since production will be running from Sunday night until Thursday a thorough pre-op will not be completed each day, nor will a complete clean up be performed until the end of the week.

 

Certainly some has experienced this type of change. How did your operational paperwork change? Did it change to match your production reporting?

We have a shift hand off where the new shift does the pre-op check and both shift operators sign.  

Dear P&S and others - Not sure I understand how a PRE-op inspection can be conducted on equipment and surfaces that have not been cleaned and sanitized. Under FSIS, conducting an SSOP inspection between full sanitation clean-ups is considered an operational inspection. That fact of when it is done in relation to processing is not paramount. Again, under FSIS, you have to have some methodology to determine that you are maintaining sanitary conditions past the first 24 hours after a full cleaning. This is typically done by conducting micro testing on product contact surfaces before the switch and setting statistically valid control limits. I have attached a couple of the FSIS documents that might be useful in setting up a program.

It is important to know the standards and follow them in order to maintain the good safety. There might be different norms related to different countries, make sure to follow them.

A cleaning inspection is different to a pre-operational checks

One of our production lines is moving to running continuously from Sunday night to Thursday afternoon. Currently every day we are doing a pre-op inspection for sanitation, plus all weight checks, lot numbers, sanitation sign off, overrun product, product from last run, etc.

Since production will be running from Sunday night until Thursday a thorough pre-op will not be completed each day, nor will a complete clean up be performed until the end of the week.

 

Certainly some has experienced this type of change. How did your operational paperwork change? Did it change to match your production reporting?

 

 

After start up you would still do all your pre-op checks & product checks at change overs and predetermined intervals with the exception of sanitation. For batch codes I would normally change at midnight each day although if the shift started at 10pm say I would consider running the batch codes for 24 hours from then and file the operational paperwork separately for each day/batch code.

 

A word of warning though, it is important that you have determined that the reduced frequency of cleaning does not have a detrimental effect on the quality of the product as I have been into a site to sort out problems generated by this sort of change.

 

Regards,

 

Tony

This is our current Pre-op sheet for daily checks:

We're moving to 24 hr/day next week and I'm unsure that I need the Pre-op sheet when we use:

 

Can someone please shed some light on this? It seems like for the first day of production I would have the pre-op sheet, but after that it would be the sanitation checks as well as the other quality checks that are currently in place.

 

 

The comments I would make are: - On the Pre-Op form, I would separate equipment and other product contact surfaces from non-product contact surfaces. Not sure about FDA, but USDA treats these differently, unless you choose to combine them. - During the week after Pre-Op has been conducted, will you be doing any cleaning and/or sanitizing activities(dry or wet)? If so, you should be documenting these. - Will you be conducting any activities to verify that product surfaces are as sanitary later in the week as they were before Pre-Op cleaning frequency was reduced? Again, this is a USDA requirement, not sure about FDA. - I would add sanitary condition checks to your Operation inspection sheet to show that your new procedure is maintaining sanitary conditions Keith