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Is using outdated form for records on the floor consider a deviation?


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#1 Charles193

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Posted 28 March 2018 - 12:48 PM

Hi  guys,

 

Please am just wondering should I initiate a deviation report for  an outdated copies of form I found on the floor yesterday being used by the Operators?

 

I do not know how they came about the forms -  we always ensure will take out all forms whenever an forms are updated or revise



#2 FSQA

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Posted 28 March 2018 - 01:10 PM

Yes, an internal deviation should be initiated (with CAPA), as this is a violation of document control policy (if you have one in place).



#3 Scampi

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Posted 28 March 2018 - 02:58 PM

My hunch is the operators squirreled away copies somewhere convenient for them to get at so they didn't have to come back to the master binder to get more. 

I always include a mini training session when a new version of an operational record is made. Then you can ask for old ones back to destroy, the operators know what version they should be using and why or what is different on the newest one. 

 

I would also suggest you move to a master binder if you don't already have one, kept close to the copier for ease of use, and limit the number of staff who are authorized to make copies, it limits the number of people you have to talk to find out where the documents came from


Because we always have is never an appropriate response!


#4 Charles193

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Posted 29 March 2018 - 01:23 AM

Thank you all for your  help. Yes we have document control procedure in place.

 

And we also have a master binder -  and Line Leads are the only authorized employee(s) to make a maximum of  20 copies  of any require Form or CCP monitoring form at a time.

 

I have initiated a deviation report in regards to this .....  Thanks once again!

 

 

 



#5 bryan63

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Posted 29 March 2018 - 03:43 PM

We do not allow multiple copies of a form on the floor.  Forms being used should be verified by the operator and or line lead, tech, supervisors, etc during first audit of the day.



#6 Hoosiersmoker

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Posted 29 March 2018 - 03:59 PM

Our biggest issue was supervisors copying the document to their desktop and printing from there. No way to determine if the document had been revised.






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