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Verification that Manufacturing Equipment has maintained a Validated State
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Verification that Manufacturing Equipment has maintained a Validated State
Verification that Manufacturing Equipment has maintained a Validated State
Verification that Manufacturing Equipment has maintained a Validated State
Verification that Manufacturing Equipment has maintained a Validated State
Verification that Manufacturing Equipment has maintained a Validated State
Verification that Manufacturing Equipment has maintained a Validated State
Verification that Manufacturing Equipment has maintained a Validated State
Verification that Manufacturing Equipment has maintained a Validated State
Verification that Manufacturing Equipment has maintained a Validated State
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manufacturing equipment, medical device company or industry, validation of machines equipment processes design etc.
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  Post Number #9  
Old 15th April 2015, 06:46 PM
Ronen E

 
 
Total Posts: 3,433
Re: Verification that Manufacturing Equipment has maintained a Validated State

Quote:
In Reply to Parent Post by Vthouta View Post

Since you are working in growing medical device industry this could be a good read based on your application

http://www.fda.gov/Drugs/GuidanceCom.../ucm064971.htm

For process validation - http://www.fda.gov/downloads/Drugs/G.../UCM070336.pdf

Based on this document, you can tweak according to your needs. I do completely agree with Ronen that there is no specific standard practice, but if you comply to FDA CGMP it would be a good practice to begin now and helpful in long run.
I didn't refer to a "standard practice" for equipment validation (in fact I do know a few of those); rather, I was addressing what the OP was after - a "standard practice" for verifying that the equipment is still in a validated state (i.e. doesn't require re-validation).

Cheers,
Ronen.

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  Post Number #10  
Old 17th April 2015, 06:48 PM
Grimaskr

 
 
Total Posts: 17
Re: Verification that Manufacturing Equipment has maintained a Validated State

I'm not sure if it's applicable to the medical industry, but in various electronics manufacturing plants I've worked in we do a checklist and 'release to production' form after maintenance or engineering experiments have tampered with manufacturing equipment.

It's just a tickler list that asks questions like:
  • Have all safety features (shield, guards, alarms, etc) been reactivated?
  • Have all facilities (water, power, air, etc) been re-connected and checked?
  • Have all process controls (vision systems, guides, etc) been checked?
  • Does any of this maintenance/engineering activity require re-validation of product before release to production?
  • And various other types of reminder questions.
The engineer responsible for the equipment needs to sign off on the checklist before Production starts running parts again. It serves as a good reminder system and shows auditors that you are double-checking things after tampering with equipment.

But again, I'm not familiar with medical industry rules/regs... so I don't know if this is applicable.
Thank You to Grimaskr for your informative Post and/or Attachment!
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  Post Number #11  
Old 18th April 2015, 10:22 AM
Person_n_PA

 
 
Total Posts: 1
Re: Verification that Manufacturing Equipment has maintained a Validated State

Quote:
In Reply to Parent Post by dedvalson View Post

I am a QA manager with a growing medical device company, I have been tasked with setting up a workflow to verify production line equipment has remained in a validated state after it has been taken off the line for a repair.
Is there any guidance documents or industry standard practices which I could model my workflow from?
I too work in the medical device field. The product lines I oversee as QE are manufactured by Swiss-style turning centers (Star, Citizen, Mazak) and vertical mills (Matsuura, Robodrill). The non-conforming (NC) material process outputs records and data that are routinely used to gauge the state of the validated manufacturing processes. The NC process has evolved from a simple one page form completed by one QE - to document the finding and how the material was dispositioned - to something that requires documented evidence supporting decisions and claims as to a) the extent of the non-conformance (bounding), b) the risk to end users, d) actions taken (corrections, etc). Today, NC forms are signed by two QEs; one to sign for the investigation and to approve the disposition and actions taken and a second to verify the documented evidence of those actions. Of course the NC process requires documented evidence of acceptance activities (inspection). And there's more. A Process Monitoring process is used. It involves an audit of the processes at each machine tool every six months. So separate but integrated QA processes (acceptance activities, non-conforming material and process monitoring) combine to help identify any shifts in the validated state of the manufacturing processes and thus ensure the quality and compliance of the product.

Hope this helps.

PS: If you need to demonstrate validated state after changes are made (e.g., machine tool moves, repairs after crashes, process changes, etc.) your Process Validation procedures should address this. In certain situations, re-validation (either full or partial) may be required.

Last edited by Person_n_PA; 18th April 2015 at 10:34 AM. Reason: to include post-script
Thank You to Person_n_PA for your informative Post and/or Attachment!
  Post Number #12  
Old 18th April 2015, 09:53 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,254
Re: Verification that Manufacturing Equipment has maintained a Validated State

Quote:
In Reply to Parent Post by dedvalson View Post

I am a QA manager with a growing medical device company, I have been tasked with setting up a workflow to verify production line equipment has remained in a validated state after it has been taken off the line for a repair.
Is there any guidance documents or industry standard practices which I could model my workflow from?
Identify changes requiring re-validation... (Perhaps the only guidance or standard practice) ....
Workflow >>>
Repair is one such change...
This effects installation...
So do the installation qualification (IQ)
Decide if the nature of repair poses a risk to the operations...
Depending upon that perform a PQ or OQ & PQ
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