Paperwork review and 'sign off' requirements
Hi everyone,
Quick question about paperwork review for forms or data generated by techs. Every lab or company I have been involved with always has a spot for someone to check, review, or verify the information on the paper. Is this an FDA requirement, and if so which CFR?
They only thing I have seen in the SQF code is under 2.2.2.1 which states "The methods and responsibility for undertaking monitoring activity, verifying, maintaining and retaining records shall be documented and implemented"
We have a lot of forms in place with no spot for a signature or review and I want to know if this is a requirement.
Thanks
Record review is a requirement under FSMA
- "All monitoring and corrective actions records must be reviewed within 7 days from the time they were created.
- Preferably prior to release of product
- Verification records, including calibration, product testing, environmental monitoring and supplier program records
- Reviewed in a reasonable time
- Performed or overseen by a Preventive Controls Qualified Individual
When issues are identified during the review, corrective action is required."
I don't think there is a stipulation that a signature or sign off line be part of the document, but inserting a line may be good practice to help ensure forms are reviewed and then signed.
It's part of haccp verification 101
If you see "(M)" by a section of the SQF code, then it is mandatory to implement. Section 2.2.2 is mandatory.
My opinion is that the tech filling out the form should at least initial and date the form. The supervisor/manager who reviews the form should at least initial and date. Thus two spots for initials/signature with date.
If the techs are checking something to verify quality levels or food safety, then your auditor will want to see signature and date.
FDA, see the following: https://www.fda.gov/...n/UCM113920.pdf
If you don't have a spot and not wish to update all of your forms to include one, then initial and date somewhere in the margins where there is enough space. Update your procedure to reflect this as the accepted practice for the review.
Can anyone provide insight as to Experimental or R&D type items that will not be shipped anywhere?
Do these products still need to be record reviewed?
Can anyone provide insight as to Experimental or R&D type items that will not be shipped anywhere?
Do these products still need to be record reviewed?
Not required unless they are for sale or go into product for sale and distribution.
To add to other suggestions you could get a stamp for the person reviewing to use with boxes for signature/date etc.
Kind regards,
Tony
Does the reviewer of Corrective Actions need to be HACCP certified for SQF?
Does the reviewer of Corrective Actions need to be HACCP certified for SQF?
Absolutely..........particularly for reviewing corrective actions.......otherwise how would they know if the CA will work or even come close?
Now that does not mean they need to be an SQFP, but they should know their way around HACCP 101