2 replies to this topic

[Anne Z]

Hello,

During a customer audit the auditor made the following remark:

- The changing of the filter (CCP) at our filling line (filling drums with edible oils) need to be registered.

The filter is changed after every batch, any remarks of the filter will be writen down on the working order by the operator. There haven't been any remarks or complaints about the filter being ripped etc. The changing of the filter is writen down in the workinstructions.

Is this enough? The auditor wants a new list with dates etc. but I'm not a big fan of new lists. Also there is no space near the fillingline where I can put the list.
Chance are that if I put the list in a different area they will forget to fill in the list. Any ideas?

Kind regards

Anne

[Charles.C]

Hello,

During a customer audit the auditor made the following remark:

- The changing of the filter (CCP) at our filling line (filling drums with edible oils) need to be registered.

The filter is changed after every batch, any remarks of the filter will be writen down on the working order by the operator. There haven't been any remarks or complaints about the filter being ripped etc. The changing of the filter is writen down in the workinstructions.

Is this enough? The auditor wants a new list with dates etc. but I'm not a big fan of new lists. Also there is no space near the fillingline where I can put the list.
Chance are that if I put the list in a different area they will forget to fill in the list. Any ideas?

Kind regards

Anne

Dear AnneZ,

I'm afraid that IMO the auditor is correct.
Basically I think he/she is commenting that the record of the monitoring step for the CCP (condition of filter) is incomplete,ie no data = no evidence.
The problem is maybe analogous to auditors requiring positive rather than negative release.
Sometimes lists are inevitable .

Rgds / Charles.C

[Madam A. D-tor]

Dear Anne Z,

As Charles already mentioned your auditor is correct.
There must be records of the monitoring of the CCP. These records should include: date, result and autograph of person who is responsible for monitoring.

I think you only need a small adaption.
As I understood, the filter is checked after each produced batch. If there are any problems/remarks, the operator records this on the work order.
If you make a dedicated space on the work order form, where the operator can write down: time of check, result of check, taken correcitve actions (if needed), you will be fine. You then would not need another form.

Hope this is of any help.