3 replies to this topic

[qualityhr]

Hello!

 

I am a QM at a small dietary supplement manufacturing facility. I am struggling to find information regarding quality expectations when production is running.

 

For example, can production run while there are no employees from the quality department present? Would the QM need to be on call in this instance? Does any management in general need to be present if production is running?

 

Thank you! 

[Brothbro]

For live production, it depends on the level of training of your staff. There are likely some quality control checks that you perform during production that can't be ignored (capsule fill counts, weights, label reviews), are your production staff trained to perform these checks? Would there be a supervisor present to verify that these checks are being performed? Is the supervisor trained to stop production when issues arise? Typically, only the quality department has the authority to release product after production. So if they were absent, product would need to be held for review by the QM before being released to distribution. (<<This is usually the case anyway since testing of samples can take a few days post-production.)

 

Personally, I wouldn't run production if there were no supervisors or management staff available. All operations require some amount of oversight and monitoring. But to my knowledge it isn't a requirement that the QM be present whenever production is running. What -is- a requirement is that all the products you manufacture adhere to your established specifications and are reviewed by your quality control system before release.

Edited by Brothbro, 09 January 2024 - 05:13 PM.

[MDaleDDF]

I agree with the brothbro.   So the answer to me is no, with an asterisk.   I'm QM, but my lab tech is awesome, and she handles most of this stuff while production is running because I'm busy with FSTL stuff.  BUT!   One of us is always here while production is running, and handling QA checks, any metal kickouts, etc.   So someone has to be there.   Does it need to be QM?   No.  

[Setanta]

I'm in agreement with the folks above!