There are external forms available for users and non-users of iPassport to report Incidents, Non Compliances and Change Control Requests. This section focuses on Non Compliance reports; more details about external forms are available in the user guide, System Preferences.
The forms can be enabled or disabled according to company practices. If they are enabled, it is necessary to declare a default Organisational Unit to ensure all the forms have an initial landing place and they are not left unattended. The external Non Compliance form has an OU field for those who know where to direct the report so the default OU is there as a safety net.
To set up availability of the external form for Non Compliances:
To access the external form, add ‘/report_non_compliance’ to the URL address of your iPassport account (e.g., https
Non-compliances are created and kept within an Organisational Unit so each OU can have its own team in charge of receiving and processing incoming reports of non-compliances. This team can consist of only one person but in any event, it has to be conformed as a ‘Distribution List’. Distribution lists are easily created in the Laboratory Management module (Laboratory Management > Distribution Lists).
To assign a distribution list of users who should be informed when a non-compliance is reported externally:
A comprehensive set of permissions is available to tailor access and authority in the Non Compliance area.
Each non-compliance is placed within an OU and the permissions only apply to noncompliances in the OUs where the user has been granted them.
However, the items of editable lists like noncompliance ‘Categories’, ‘Levels’, ‘Origins’, ‘Escalated To’, ‘Impacts’ or ‘Effectiveness Status’ are shared by all OUs in the facility.
Permission | Description |
---|---|
Non Compliance:Change Compliance | Allow a user to set a non compliance as corrected |
Non Compliance:Change OU | Allow a user to move non compliances to the selected organisational unit |
Non Compliance:Change Status | Allow a user to change the status of a non compliance |
Non Compliance:Create Non Compliances | Allow a user to create a non compliance record |
Non Compliance:Create Reports | Allow a user to print a non compliance report |
Non Compliance:Delete Corrective Types | Allow a user to delete Corrective Types |
Non Compliance:Delete Levels | Allow a user to delete non compliance levels |
Non Compliance:Delete Preventative Types | Allow a user to delete Preventative Types |
Non Compliance:Delete Remedial Types | Allow a user to delete Remedial Types |
Non Compliance:Delete Root Causes | Allow a user to delete Root Causes |
Non Compliance:Edit Corrective Types | Allow a user to edit Corrective Types |
Non Compliance:Edit Levels | Allow a user to edit non compliance levels |
Non Compliance:Edit Non Compliances | Allow a user to edit Non Compliances |
Non Compliance:Edit Preventative Types | Allow a user to edit Preventative Types |
Non Compliance:Edit Remedial Types | Allow a user to edit Remedial Types |
Non Compliance:Edit Root Causes | Allow a user to edit Root Causes |
Non Compliance:Link To Records | Allow a user to link to and from non compliances |
Non Compliance:Manage Action Statuses | Allow a user to edit types of Non Compliance Actions |
Non Compliance:Manage Action Types | Allow a user to edit types of Non Compliance Actions |
Non Compliance:Manage Actions | Allow a user to manage Non Compliance Actions |
Non Compliance:Manage Effectiveness Statuses | Allows a user to create, edit and remove Effectiveness Statuses |
Non Compliance:Manage Non Compliance Categories | Allow a user to Edit or Delete Non Compliance Categories |
Non Compliance:Manage Review Tasks | Allow a user to manage review tasks for non compliance documents |
Non Compliance:Schedule Reviews | Allow a user to schedule reviews for non compliance documents |
Non Compliance:Search Non Compliances | Allow a user to perform a search for non compliance documents |
Non Compliance:Verify Actions | Allow a user to verify Non Compliance Actions |
Non Compliance:View Deleted Actions | Allow a user to view deleted Non Compliance Actions |
Non Compliance:View History | Allow a user to view the change history for non compliances |
Non Compliance:View Non Compliance | Allow a user to view non compliance records |
Non Compliance:View Root Causes | Allow a user to view Root Cause Analysis Details |
Non compliance permissions appear in the following system roles:
Global Viewer (excluding admin) and Global Viewer (excluding admin and personnel records):
Global Editor (excluding admin) and Global Editor (excluding admin and personnel records):
Audit Editor:
Audit Viewer:
NEXT STEP: Raising a New Non Compliance
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