4 replies to this topic

[Jpainter]

Does anyone have an example of a GMP violation form that works well for them? I currently have a form for this, however it is not the most user friendly form. I would like to have a simple one page form that covers issues dealing with in facility GMP violations. Does everyone maintain their GMP violations and disciplinary actions on a separate form? I would like to ideally combine these forms to have less confusion for area supervisors on what form should be used for violations. 

[nwilson]

I like to us a log or register of the violation.  This way you can categorize by violation or department for trending or KPI's.  Also adding in the manager or supervisor this issue was reported to at the time of the noted violation helps with keeping everyone honest about the issue(s). 

 

 GMP Violation Checklist.xlsx   11.21KB   249 downloads

 

 

[Watanka]

 FORM 12.1.001 GMP VIOLATION REPORT.pdf   53.94KB   307 downloads

 

This is the form we use.  It lists the most common GMP violations we see.  Typical correction is education and fix the issue immediately.  E.g. "VI - sweater removed to personnel locker."  VI = Verbal Instructions.  Used by department managers to document employee compliance with GMPs.  Copied to QA Manager for trend analysis.  Since it was put in place, GMP violations have been reduced very significantly, especially after the first time the evidence was used for a disciplinary action.  Had one auditor object to the use of the word "violation".   I asked them to cite the regulation/code that prohibits the use of that word.  No response.  Case closed.

[Charles.C]

FORM 12.1.001 GMP VIOLATION REPORT.pdf

 

This is the form we use.  It lists the most common GMP violations we see.  Typical correction is education and fix the issue immediately.  E.g. "VI - sweater removed to personnel locker."  VI = Verbal Instructions.  Used by department managers to document employee compliance with GMPs.  Copied to QA Manager for trend analysis.  Since it was put in place, GMP violations have been reduced very significantly, especially after the first time the evidence was used for a disciplinary action.  Had one auditor object to the use of the word "violation".   I asked them to cite the regulation/code that prohibits the use of that word.  No response.  Case closed.

 

Hi Watanka,

 

An Impressive list. Definitely Magisterial !

 

Might add-

 

Perfume/Aftershave

False Eyelashes/Fingernails

 

PS - Is "necklasses" an American spelling ?

[Watanka]

Added. Americanized version is necklaces, but the incorrect spelling may be more descriptive  

.

 

Thank you Sir Charles!