GDP - Having to provide a reason when writing N/A?

NikkiQSM

Quite Involved in Discussions
#1
Hello All -

Apparently, our company has not been following GDP as closely as it should.

But we are putting the training in place now and hope it goes smoothly.

While going on this training, it states that the person completely a form, much initial, date and provide a reason when documenting "N/A".

We have a medical clean out which is completely for every product we produce. This does not mean a medical clean out is required for every product. It lists out all the steps of the medical clean out and at the bottom, there is a section for QC to approve the line clearance. Line clearance is required with every job.

When a medical clean out is not needed, the operator put N/A next to all but a couple steps of the medical clean out.

Does this mean he hates to write a reason for N/A next to every N/A?

Thoughts?

Thanks,
Nikki
 
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QAengineer13

Quite Involved in Discussions
#2
Hello All -

Apparently, our company has not been following GDP as closely as it should.

But we are putting the training in place now and hope it goes smoothly.

While going on this training, it states that the person completely a form, much initial, date and provide a reason when documenting "N/A".

We have a medical clean out which is completely for every product we produce. This does not mean a medical clean out is required for every product. It lists out all the steps of the medical clean out and at the bottom, there is a section for QC to approve the line clearance. Line clearance is required with every job.

When a medical clean out is not needed, the operator put N/A next to all but a couple steps of the medical clean out.

Does this mean he hates to write a reason for N/A next to every N/A?

Thoughts?

Thanks,
Nikki
HI Nikki,

"When a medical clean out is not needed, the operator put N/A next to all but a couple steps of the medical clean out."

My 2c's at the end of the form , you should include a Summary of some sort where the Justification/rationale for N/A , if applicable..........."Should be written by the QC" and sign ,date.
 
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