Documenting Cleaning Production Lines in Medical Device Pkg facility

C

channelr

Hello all,
I was hoping some of you could share with me how you are documenting your cleaning program for your production lines and how long you retain the cleaning records? Do any of you use SharePoint to document any of it or the audits? We are trying to go paperless and are hoping to bounce ideas off other facilities

We are trying to update our facilities cleaning program. We wanted to get rid of the shift cleaning check list that is paper and possible go with a 24 hour wipe off board with a camera at each center that takes pictures of the cleaning board every 12 hours to ensure the data integrity of the orig. record is retained in a picture and attached to the Supervisor audit file. What are your thoughts on this? Would this be complaint for an ISO 13485:2016 audit or FDA inspect
 

v9991

Trusted Information Resource
i am from drug product background, and recently started with combination products ( device + drug); so while device friends start correcting/pitching in., here's :2cents:

its certainly an novel idea; but little too creative;
checklist aside, is shift-cleaning an critical function of manufacturing operation. ( because, in drug products, this is super-critical wrt contamination, cross-contamination, mix up etc )

What are your thoughts on this? Would this be complaint for an ISO 13485:2016 audit or FDA inspect
from context of (FDA)audit, it is important to have 'risk-assessment', change-management, 'validation' of proposed solution in place.

However, the solution itself may be very difficult to convince as reliable becuase, there is little control on status-board; ( viz., changes/updates/modification to the board are not really reflected, unlike an paper records or other conventional electronic-forms)

it makes even more critical from the recent flood of FDA audit observations and warning letters wrt Data Integrity.
:2cents: once again this is approaching the solution from drug product perspective, look forward for comments from device-experts.:cfingers:
 
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