When revised documents, relationships, processes and training inventories are held in separate sources, their fields must be matched by hand before a list of affected documents and responsible owners can be prepared.
The quality systems manager must compare every suggestion in the list of affected documents and responsible owners with its source record; missing or conflicting evidence must not replace the final decision.
If similar wording that applies to a different site is not set aside for review, a critical linked record could be missed; the record must not proceed without a human decision.
The quality systems manager compares the list of affected documents and responsible owners with the supporting record. The workflow pauses when similar wording applies to a different site. The responsible person can revise or reject the suggestion, or request further information.
Only the fields required for this decision should be processed from the revised document, relationships, processes and training inventory. Access to the source systems must be authorised separately from the quality systems manager role, and personal data, commercial information and technical secrets must not be passed into the model context unnecessarily. Reading, suggestions and human decisions must be logged separately.
A good fit
Not a good fit
Revised documents, relationships, processes and training inventories can be received through an API or controlled file transfer. Fields whose source and version cannot be established are not treated as confirmed information.
The record goes to the quality systems manager for review when similar wording applies to a different site. If supporting evidence is missing, no action is taken in the target system.
No. The list of affected documents and responsible owners remains a draft until the quality systems manager approves it. Acceptance, revision and rejection are recorded in the processing log as human decisions.
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