13 replies to this topic

[DS1]

Anytime there is a quality deviation at my facility, we need to write a report on a controlled document that explains what happened. Our facility was recently purchased by a larger company so we have altered our controlled documents to express this alteration and also added a new segment to this form. Since we have done this, we have a new effective date on the report form. If this new form has an effective date of 10/1/18, would there be any ramifications of taking a document that was originally submitted on 6/1/18 on this controlled document under the previous ownership and resubmitting it on the new format?

[MsMars]

Are you saying that you are still investigating your quality issue from 06/01/2018, or just transferring the information to the new form? I would transfer to the new form only if you are still investigating and can use the additional section on the form to aid your investigation. Just make a note somewhere of your intentions and reasoning; bottom line is to be transparent about what you are doing in regards to the new form.

[DS1]

The quality issue from 6/1 has been long solved and filed away. I am worried about putting information about a quality issue from 6/1 with a resolved date of 6/5 onto a form with an effective date of 10/1.

[Scampi]

This is when you're change log comes into play. As long as you have logged that the NEW document you're using removed the OLD one from use, then you are all good

[FSQA]

As Scampi stated above , if you have updated the info in your document control (register), you necessarily dont need to update the (completed) form of 06/01. You can still file that form as part of your records and use the updated form for any further issues.

[DS1]

Thanks for the help. We do have a controlled document tracker that shows the change, I was mainly worried about having auditor having a problem with a resolved date on a form that was earlier than an effective date. Seemed a little fishy to me. 

[Scampi]

Is there a reasonable explanation to why this had not been completed as yet?  All you can really do here is add you're own comments on a separate page that speaks specifically to the document revisions and why the long delay, things do happen from time to time, better to be honest and transparent than try and cover anything up

[DS1]

Someone in our department just decided that the old forms need to be transferred over instead of letting them be and using the new ones from here on out. This move worried me for two reasons: 1) an auditor might be concerned that we have changed things while transferring them over and 2) this move might set a precedent that every other older form needs to be moved over as well.

[MsMars]

Someone in our department just decided that the old forms need to be transferred over instead of letting them be and using the new ones from here on out. This move worried me for two reasons: 1) an auditor might be concerned that we have changed things while transferring them over and 2) this move might set a precedent that every other older form needs to be moved over as well.

 

As someone else said, you hopefully have your document change log completed for the revisions to the form. You may just have to make another note on the log that some of the completed forms were revised to the new format and make another list of those that were revised. I would definitely let your co-worker know to leave the old completed forms as-is in the future... and maybe add something in your document control policy about any document revisions/modifications being approved by you and/or others on your food safety committee. :)

[Scampi]

Oh wow, now I understand you're concern!  I didn't realize the extent of the issue

 

To add to Ms Mars...........is there a controlled binder of blank records?  Everyone knows they are only to take copies from that binder and only a couple of people are able to revise/remove old copies?  This is the only way (unless some folks take 50 copies of something and you are not aware) to actually "control" the hard copies

 

You are correct, this should NOT have happened..........you could ask the employees in question to sign an attestation that nothing was omitted.............they didn't attach the old ones???  I'm guessing this wasn't a QA person who did this

[DS1]

Oh wow, now I understand you're concern!  I didn't realize the extent of the issue

 

To add to Ms Mars...........is there a controlled binder of blank records?  Everyone knows they are only to take copies from that binder and only a couple of people are able to revise/remove old copies?  This is the only way (unless some folks take 50 copies of something and you are not aware) to actually "control" the hard copies

 

You are correct, this should NOT have happened..........you could ask the employees in question to sign an attestation that nothing was omitted.............they didn't attach the old ones???  I'm guessing this wasn't a QA person who did this

It was a quality person that did this. That is another issue. The completed reports are kept in a shared drive and one copy of each is printed and placed into a binder. He has removed the old copies and added in the changed versions. 

[Scampi]

Perhaps moving forward, scanned copies are kept only and hard copies kept on file. That was no changes can be made once an item is closed.

 

I do still think you should add you're own NCR to the entire file. What your CA and RC were. Put it all together, and I cannot see any auditor faulting you for that.

[DS1]

Thanks for the help everyone.

[MsMars]

It was a quality person that did this. That is another issue. The completed reports are kept in a shared drive and one copy of each is printed and placed into a binder. He has removed the old copies and added in the changed versions. 

 

For documents such as HACCP/quality deviations, employee warnings, corrective actions, etc. it's always wise to have multiple sign-offs of all parties involved on a hard copy of the document once the investigation, resolutions, and corrective actions have been finalized to prove that everyone involved has reviewed and approved of the content.