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Affected Objects Table(s): Failure Codes (QMS)

Affected Objects Table(s): Failure Codes (QMS)

Only the Customer Experience Management module contains Failure Codes (FMEA) table, that table does not exist in the other quality modules; both in Intake and during Investigation.  Clients have asked numerous times where Process FMEA tables and codes are stored.  They expect them to be in a spot that is different than the current dFMEA codes.  Numerous clients are now participating in the FDA Medical Device Single Audit Program (MDSAP) to reduce the number of audits and harmonize with the new ISO 13485:2016 standard.  They have commented that codification needs to be consistent across QMS modules to participate in the MDSAP program.  Currently there is no codification with the NC records, only dFMEA codes on the CEM records and a risk tree on the CAPA records, which is confusing and not logical.  Lastly Manufacturer parts, Vendor parts and software parts don’t support adding FMEA codes OOTB.

 

1 Comment
olivierlp
Community Manager
Status changed to: Archived

Hello,

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