6 replies to this topic

[scoot915]

I searched for this problem but did not find anything, possibly because it is such a stupid error no one has done it before

 

After two 3rd party audits, daily monitoring and weekly review I just noticed I have a < (less than) instead of a > (greater than) sign  before the critical limits regarding temperatures for one of our freezers.

It is correct in my written plan but incorrect on the actual monitoring sheet.

The temperature monitoring is not a CCP but is now a PC for FSMA

 

I can correct the sheet in time for my FSMA compliance date and hope the FDA doesn't ask to look back before the compliance date, but I still have years of monitoring records for future 3rd party audits.

 

I was thinking of just correcting the monitoring sheet and hoping at the next audit it will not be noticed, but I believe the correct thing to do is write a corrective action stating the error and that the monitoring sheet was corrected as of today.

 

Is that the correct way to handle this?

 

Thanks for any help

[FurFarmandFork]

If it's just a paperwork error, and your refrigeration temperature was recorded at the correct temperature, then document the paperwork error and the correction, so that if they look at the old paperwork and notice, they understand it was a typo and didn't play a role in food safety.

 

If instead you actually recorded data where for example you had your refrigerator in excess of the necessary limits, you have much more work to do to demonstrate why you shouldn't have to issue a recall for products produced within those dates.

[scoot915]

Thankfully it was just a paperwork error.

 

I was overthinking that documenting the error would send up a red flag.  

But as you noted, since temperatures were recorded correctly it should be fine.

 

Guessing that even the auditors missed it because the recorded temperatures were obviously correct.

 

Thanks for your help!

[Ryan M.]

Correct the form.  Then document the correction and explanation.  It is so simple any auditor or inspector will understand the error and see that in all practicality there was no harm.

[Panos]

Since you have the temperatures recorded it is not such a big deal. Just make sure that all your temperatures fall within the acceptable limit and make your correction. 

[Gerard H.]

Dear Scoot,

 

Here is what I could find in the BRC norm about making alterations:

 

"Record completion and maintenance

 

The company shall maintain genuine records to demonstrate the effective control of product safety, legality and quality.

Records shall be legible, maintained in good condition and retrievable. Any alterations to records shall be authorised and justification for alteration shall be recorded."

 

By doing so, in addition to the suggested actions above, the only thing to say about is that you apply the right quality system principles. It results in some work now, however you will be more sure during future audits.

 

I wish you good luck in resolving this question.

 

Kind regards,

 

Gerard Heerkens

[scoot915]

Thank to all for the help.

 

Feel better about it now but still kicking myself for making such a stupid error