7 replies to this topic

[LivingHealthy86]

Would anyone happen know if there was a regulation or guidance document regarding production writing ahead on there document. For instance, if the next salad is thought to be coming down the line and they writing down that product is starting, but for some reason the product is now not going to run that day or the production order changes. All products are wrote on on-going documents per shift as we have short runs. The current practice where I am, when reviewing documentation if there is signs of writing ahead a CAPA is issued as it is considered falsifying documentation. Could we be over doing system is my question? 

[olenazh]

Your production records shall be true and not misleading. They should reflect real data: product name, date, etc. - so, no writing ahead. I'm not aware of regulatory documents requiring that, but what I know is: it is a manufacturer's responsibility to supply consumers with products which are safe for human consumption. However, if your production record is falsified - a corresponding product cannot be considered safe, can it? That's my thoughts.

[Kara S.]

Yeah - they shouldnt be writing ahead - you can train to do the single line crossout with initials and dates - have them write a comment that schedule was changed.

 

For errors like that - we did not classify that as a deviation from the food safety plan needing a CAPA. We would treat it as a GMP violation which was still documented, but through the HR process. GMPs (not something that needs to be documented per regulation), PPE, and operational rules like being caught not washing hands or wearing safety glasses were basically "breaking" the basic plant rules stated and signed off on, day 1 and throughout their training period. So that is just something that was not documented within the CAPA program. 

[Brothbro]

To build off what post 2 and 3 have stated, it sounds like the way your record-keeping system is designed lends to these types of errors. The documentation (on-going record) sort of encourages operators to write the next product scheduled. A change in the production schedule is not a GMP non-compliance or a deviation in and of itself, but it sounds like they become record-keeping errors simply because of how your system is designed. Have you ever considered switching to a form-based record keeping system, where each production run is instead recorded as its own separate form? 

[SafetyP]

"Would anyone happen know if there was a regulation or guidance document regarding production writing ahead on there document?"

 

Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements | FDA

[jfrey123]

From a tip sheet from SQF on the topic of records:

 

Tip-Sheet-9-Document-Control-and-Records.pdf (sqfi.com)

 

 

3. Records

a. Records collect and retain the information about processing operations recorded on forms, which must be clear, concise, legible and accurate.

 

Most GFSI and regulatory codes will have a mention of "accurate" records.  Prefilling a form is an inaccurate practice, as you cannot predict the future.  A 5 minute delay in the appearance of that next salad will make your form inaccurate unless corrected.

 

And I get that it seems like a small issue, just prewriting the time.  The problem is that allowing them to prefill the times will lead to prefilling of other form items, maybe leading to them initialing or signing the form as complete before it actually is.  I've run into instances where an operator handed me a form reflecting a shift full of checks that I know were not performed because their equipment went down half way through the shift, but the operator didn't think about that as they'd prefilled the whole form at the beginning of shift and just turned it in absent mindedly.

 

So you might not specifically find "prefilling forms" as a topic addressed in regulations, but any form you fill out needs to be accurate in the moment it is reviewed.  And prefilling times that haven't occurred yet make that form 100% inaccurate.

[G M]

Would anyone happen know if there was a regulation or guidance document regarding production writing ahead on there document. ...

 

You mention salad but not what regulatory framework or GFSI scheme you're inspected under, so its a bit tricky to suggest relevant regulation.

 

For FSIS inspected facilities we have CFR Title 9.III.E.417-5.b  https://www.ecfr.gov...7/section-417.5

"Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry."

Edited by G M, 21 July 2022 - 08:15 PM.

[mgourley]

Regardless regulation, checks of products should be documented at the time they are conducted. Period.

 

Train that out and hold people accountable.

 

Marshall