4 replies to this topic

[Bansal]

Hello everyone,

question - Do we have to have corrective actions for monthly inspection (clause 3.4.4. BRC Edition 9). or corrections are good enough.

If yes, could you please help, how can we justify to Auditor if we just do corrections no corrective actions.

Thanks in advance

[SHQuality]

It seems like you are confused about the definitions. a corrective action is an action you undertake to deal with an immediate problem. A preventive action prevents the problem from reoccurring.

 

Auditors tend to prefer prevention over putting out fires on a common problem repeatedly.

Can you provide more details?

[SheenaQA&BRCGS]

Hello everyone,

question - Do we have to have corrective actions for monthly inspection (clause 3.4.4. BRC Edition 9). or corrections are good enough.

If yes, could you please help, how can we justify to Auditor if we just do corrections no corrective actions.

Thanks in advance

So you mean if, during the inspection, something fails so you're wondering if you need to write up a RC and CA Or just note the immediate correction?

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[Scampi]

If an issue can be immediately corrected, I always record that on the inspection record--who/when/what

 

If not, a deviation with follow up and/or a work order # is recorded on the record, as well as the follow up inspection once the issue has been fixed

[mgourley]

As with all good answers, it depends.

1) Mineral oil bottle at x location was not labeled: You grab the lead/supervisor of the area and have them go get a label for the bottle. You write it up and consider it corrected. If it happens again the next walk through, then perhaps a RCA/CAPA is necessary because apparently someone does not understand that secondary containers need to be labeled.

 

2) Pipe insulation behind mixer 2 is falling apart. Write it up and submit a work order to have the insulation replaced.

 

3) Review of CCP check paperwork revealed several instances of missing or incomplete documentation: Immediately gather the person responsible for the check and their supervisor. Explain the non-conformance and needed correction. Raise a formal NC and do the whole RCA/CAPA thing because it's a CCP and there is no excuse for not following proper procedure. Obviously there is/are things that need to be done to ensure it does not happen again.

 

Unless you have the time and people available to do a full blown CAPA for every minor thing you may find in a GMP walkthrough, they are generally a waste of time. Pick and choose, based upon risk, of course, those things that need to be formally investigated and action plans created for.

 

Marshall