4 replies to this topic

[qualityhr]

Hello! I am the QM at a small dietary supplement production facility. We are currently understaffed and production is running way behind. The company CEO often needs to come in on the weekend to make product alone. However, this does not follow our quality program in terms of always have a second person to verify ingredient weight, equipment calibration, etc. 

 

Is there any way to make this situation quality-approved? Could she be her own verifier?

 

Any guidance is appreciated, thanks!

[SQFconsultant]

The CEO can not be their own verifier.

[Scampi]

NO   you cannot check your own work

[FirstQualityConsulting]

Is there a way where the weights, equipment calibration checks, etc. can be monitored (CCTV) or automated (recorded on a computer) for verification prior to release? 

 

Otherwise, no you cannot verify your own work.

 

Also, for dietary supplements or any food/drug safety program the company must ensure adequate resources which includes humans.  The company should not perform a production run if there are insufficient resources.

[matthewcc]

I don't know what country you're in ("Earth"), but in the United States for dietary supplement manufacturing, there must be two people.  If you show her a regulation, then hopefully that will convince her.  The definition of "verify" is to check something that has been done, and you cannot check your own work.

 

21 CFR 111.210(h)(3)(ii)

 

(ii) For manual operations, such specific actions must include: 

 

(A) One person weighing or measuring a component and another person verifying the weight or measure; and 

 

(B) One person adding the component and another person verifying the addition.

 

https://www.ecfr.gov...1.210(h)(3)(ii)