I need your help interpreting the requirements of Clause 3.4.4?

I think, if there is any area with product out os the package, you need to do it monthly.

As it specifies open product areas then you should be fine to reduce the frequency, however, you do need to specify the risk assessment very clearly. An auditor wouldn't accept "we are enclosed product producers". If you have chosen a frequency different to the suggested, you need to justify why.

Is there absolutely no point where the product is open? E.g. filling?

GMO, The filling and closing of the product are fully enclosed - the closing of the product takes place in the same enclosed unit where it is filled. We will do a risk assessment to motivate our decision to change the audit from monthly to 3-monthly. We are already doing daily hygiene inspections during production at prescribed intervals.

Makayla

Completely depends wat product u producing at that site . For good manufacturing practise I will suggest keep it monthly .
Deb

I would be more inclined to reduce the daily hygiene inspections rather than reduce the monthly ones. The monthly ones are often more in depth and performed by someone more senior.

One thing worth considering if you move to 3 monthly is about non conformances. Are you and your operations team controlled and strict enough to ensure non conformances don't take 3 months to be completed? What if they're not done by the time you reaudit?

Audit non-conformances will be discussed on the monthly BRC meeting - the closing thereof must be within in time frame given on the report. I am therefore feeling at ease to change the frequency to 3-monthly.
The final decision to change will be made on the next BRC meeting.
Thanks for all your input

Hi,


I am struggling with this requirement at the moment.

Has anyone have a pro-form/ checklist to do the fabricationinspections to identify risks to the product from the building or equipment?

Thanks in advance.


Agnes

Hi,

Check out a post on the same topic started 11th June on the BRC Forum. Tony very kindly attached an example checklist to that :-)

Bev

Hi,


I am struggling with this requirement at the moment.

Has anyone have a pro-form/ checklist to do the fabricationinspections to identify risks to the product from the building or equipment?

Thanks in advance.


Agnes