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Batch Sheets and Operating Procedures

Batch Sheets and Operating Procedures

Batch Sheets and Operating Procedures

The company I work for has a few different locations. The site where I reside falls under the Process Safety Management regulations, our other locations do not.

At my location we have developed written operating procedures, and we have modeled them directly around the requirements listed in 29cfr1910.119(f) and 40cfr68.69.

We additionally have a batch sheets which follow in lock step with the operating procedures.

My personal view is the batch sheet tells you what to do / records what you did, and the operating procedure tells you how to do it.

Up to this point, our other locations, which are not Process Safety Management sites have only had batch sheets. They have decided to develop operating procedures, however they have decided they will combine these into a single document, and that we should do this at all locations.

How do others handle this? Do you have operating procedures and batch sheets? Just one or the other? Are we setting ourselves up for trouble by trying to combine these together?

RE: Batch Sheets and Operating Procedures

I'd say your system is the correct way. It is certainly the way I choose to do it.

By combining batch sheets with SOPs, it can create a record keeping nightmare when changes are made to either portion of that document. The batch sheets most likely quote quite a bit of the SOPs (like you mentioned being lock-step with one another), but the SOPs are more of general instructions, where the batch sheets can have much more minutiae built in while still referencing the SOPs.

For instance, if your process uses a particular set piece of equipment. That piece of equipment may have its own entire SOP for using it, so you can simply reference that SOP in your batch sheet instructions rather than write out the entire process of using that equipment on every batch sheet.

If it included all of the information of the SOPs that would otherwise be written as separate documents, the batch sheets would be pages and pages of instructions even for processes that are only a few steps.

Having SOPs is a way to consolidate instructions that are used a lot. If every process has its own unique SOP, that sort of defeats the purpose since the batch sheet already serves that purpose.

If you have 100 products, you've got 100 SOPs to track with that system.

With the system you employ at your site, if you have 100 products and let's say there are 10 unique groups of 10 similarly manufactured products. So you've got 10 SOPs to track.

Andrew H.

RE: Batch Sheets and Operating Procedures

We went the other way. The issue is you've got batch sheets that have to match the instructions, so you have to somehow keep them in sync. Let's say you come back to a batch sheet a year later to find out what happened, you've got to then find the corresponding instructions that match. How is that going to happen? Are you going to keep some sort of master tracking file that you have to use to look up the correct matched set? Alternately, you have to include in either document, some unique identifier to allow you to keep track of its mate, so if one document gets changed, the other must also get changed.

Configuration management is always a PITA; we mostly tend to subscribe to keeping both together in the same document. Any change is contained in the same document and they can't get separated.

TTFN (ta ta for now)
I can do absolutely anything. I'm an expert! https://www.youtube.com/watch?v=BKorP55Aqvg
FAQ731-376: Eng-Tips.com Forum Policies forum1529: Translation Assistance for Engineers Entire Forum list http://www.eng-tips.com/forumlist.cfm

RE: Batch Sheets and Operating Procedures

Thank you both for the input.

IRstuff, the nomenclature I've used for naming our files has made it fairly easy, eg "SOI - Procss A - R00 2021_01_01" so I can quickly identify what the revision and date of the revision was.

We previously did have our operating instructions and batch sheet in a single document, in the way that the batch sheet portion was an appendix to the work instruction. Is this along the lines of what you're describing?

What our group is proposing is that the work instruction and batch sheet is completely intermixed. Page 1 says "SOI - Process A". Page 2 gives all of the instructions and has blanks to sign off. Page 3 to end proceed in the same manner.

RE: Batch Sheets and Operating Procedures

We've done both, having the checklist separately, in the back, while making some things easier, makes it harder to actually use in real-time, because you need to have access and viewability to both the procedure AND the checklist AT THE SAME TIME. This calls for having the checkpoints intermingled within the procedure, so that you can see, "Do this test using this widget" and a checkbox adjacent. Makes it a little harder to hand audit the checklists, but much easier to use, particularly if you're doing a Zoom or Skype with a customer witness, since everything is one one window. For the alternate approach we had Word with split window, procedure section on top and checklist on the bottom; the operator can sometimes get out of sync and/or lost. If they had been unified, it would have been harder to get out of sync during the test.

TTFN (ta ta for now)
I can do absolutely anything. I'm an expert! https://www.youtube.com/watch?v=BKorP55Aqvg
FAQ731-376: Eng-Tips.com Forum Policies forum1529: Translation Assistance for Engineers Entire Forum list http://www.eng-tips.com/forumlist.cfm

RE: Batch Sheets and Operating Procedures

We have separated the SOPs from the batch tickets. Trying to combine them would mean hundreds of edits for a single process change, as every batch ticket would need to be edited if the process changes.

Also, combining the batch ticket with the SOP would mean a 50+ page printout for each batch made. No thanks.

RE: Batch Sheets and Operating Procedures

IRStuff, batch tickets are separate from procedures, and are printed on a per batch basis prior to making the batch, then disposed of. This is quite fine per ISO. Printed copies are also okay per ISO so long as the procedures have an automatic expiration date printed on each page - usually 2 weeks after printing.

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