Record Not Completed Correctly - What Should be the Corrective Action?

Here is a scenario:

You are reveiwing a monitoring record from the day before. You noticed that the record was not completed (e.g. record was blank, record missing, some information missing). What is your corrective action? Are you going to sign the reveiwed/verification?

This is not neccesarily a failure. The best way to address this is to make a note at the bottom of the form notating that their is something not filled out but that you can validate it was done, just not documented. Additionally, retrinaing for document and recordkeeping might be neccessary and you would add that note as well. Obviusly, document the retraining.

My plants use an addendum form where the issue is described, any CAs that can be done are documented, and details of the on-going investigation are noted. You can still sign the form...you have verified it. The addendudm form has a verification signature also. BRIAN H's comments also apply...

Depending on the document, may have other actions to take, such as placing product on HOLD pending completion of the investigation.

ya, I guess product hold is necessary for certain situation e.g missing cooking temperature record. For something like that, a micro/sensory test might be necessary?

First thing is to find out WHY the record was not completed and the CAR will be different based on that. For instance:

· The operator didn’t know how to complete it: Retraining

· The form is too complicated: Re-Design the form

· The operator is taking the measurement but notrecording immediately because the form is not available on the site where the observation ins made, it waits for “later”and at the end forgets to do it: Make form available on site

· The operator in charge was out sick and there was no back up person to complete the form or the backup was not aware: Designate backup operator and place a system that works

.........................................And so on…. I may come out lot of things, but it depends of the actual reason why.

With that said, I can tell you for sure what NOT TO DO: Do not falsify records. (that means, do not make the records to complete the form and “hide” the issue). As Brian and KTD said, make a note explaining the reason why the records was missing, and document the CAR.

I always check with personnel first why the document was not completed. Then get a little training on the floor of how to complete the forms and answer the questions. However, human factor is always present. Usually, they forget. It's ongoing process and hard to fight with it.

So many questions about this subject I dont know where to start.

 

The use of an addendum form interreges me. Would it be a generic form for records such as (Metal detection, Daily Sanitation Schedule and Pre-Operation checklist)? Or would each document have its own?

 

Besides dates, times, personnel involved and what KTD already covered what else should be included on an addendum form?

 

The way things are currently set up our Pre-Op. checklists and Metal Detector operation forms are part of our HACCP plan and are verified by a Q.A. technician and the Daily Sanitation Schedule is verified by the Sanitation Group Leader and is not part of the HACCP. Not sure if this would matter or not.