- NC Permissions & Settings

Non Compliance Permissions and Settings

External Forms Settings (System Preferences)

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:

  1. Navigate to Administration > Settings > System Preferences
  2. Click the External Forms row to open that tab
  3. Click in the field, Default OU for externally reported Non Compliances
  4. Select the appropriate OU from the dropdown menu
  5. Tick the checkbox next to, Enable External Form for Non Compliances
  6. Click Save before navigating away from the page

To access the external form, add ‘/report_non_compliance’ to the URL address of your iPassport account (e.g., https:://TestLab.ipassportqms.com/report_non_compliance).

Who to Notify of Externally Reported Non compliances (OU Preferences)

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:

  1. Navigate to Administration > Settings > Organisational Unit Preferences
  2. Select an OU from the Organisational Unit dropdown menu
  3. Open the Non Compliance Settings tab by clicking its row
  4. Select a distribution list from the dropdown menu under, Distribution List to be notified of externally reported Non Compliances
  5. Click Save

Permissions

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

Roles

Non compliance permissions appear in the following system roles:

Global Viewer (excluding admin) and Global Viewer (excluding admin and personnel records):

  • Non Compliance:Create Reports
  • Non Compliance:Search Non Compliances
  • Non Compliance:View History
  • Non Compliance:View Non Compliance
  • Non Compliance:View Root Causes

Global Editor (excluding admin) and Global Editor (excluding admin and personnel records):

  • Non Compliance:Change Compliance
  • Non Compliance:Change OU
  • Non Compliance:Change Status
  • Non Compliance:Create Non Compliances
  • Non Compliance:Create Reports
  • Non Compliance:Delete Corrective Types
  • Non Compliance:Delete Levels
  • Non Compliance:Delete Preventative Types
  • Non Compliance:Delete Remedial Types
  • Non Compliance:Delete Root Causes
  • Non Compliance:Edit Corrective Types
  • Non Compliance:Edit Levels
  • Non Compliance:Edit Non Compliances
  • Non Compliance:Edit Preventative Types
  • Non Compliance:Edit Remedial Types
  • Non Compliance:Edit Root Causes
  • Non Compliance:Link To Records
  • Non Compliance:Manage Action Statuses
  • Non Compliance:Manage Action Types
  • Non Compliance:Manage Actions
  • Non Compliance:Manage Effectiveness Statuses
  • Non Compliance:Manage Non Compliance Categories
  • Non Compliance:Manage Review Tasks
  • Non Compliance:Schedule Reviews
  • Non Compliance:Search Non Compliances
  • Non Compliance:Verify Actions
  • Non Compliance:View Deleted Actions
  • Non Compliance:View History
  • Non Compliance:View Non Compliance
  • Non Compliance:View Root Causes

Audit Editor:

  • Non Compliance:Change Compliance
  • Non Compliance:Change OU
  • Non Compliance:Change Status
  • Non Compliance:Create Non Compliances
  • Non Compliance:Create Reports
  • Non Compliance:Delete Corrective Types
  • Non Compliance:Delete Levels
  • Non Compliance:Delete Preventative Types
  • Non Compliance:Delete Remedial Types
  • Non Compliance:Delete Root Causes
  • Non Compliance:Edit Corrective Types
  • Non Compliance:Edit Levels
  • Non Compliance:Edit Non Compliances
  • Non Compliance:Edit Preventative Types
  • Non Compliance:Edit Remedial Types
  • Non Compliance:Edit Root Causes
  • Non Compliance:Link To Records
  • Non Compliance:Manage Actions
  • Non Compliance:Manage Effectiveness Statuses
  • Non Compliance:Manage Non Compliance Categories
  • Non Compliance:Manage Review Tasks
  • Non Compliance:Schedule Reviews
  • Non Compliance:Search Non Compliances
  • Non Compliance:Verify Actions
  • Non Compliance:View History
  • Non Compliance:View Non Compliance
  • Non Compliance:View Root Causes

Audit Viewer:

  • Non Compliance:Search Non Compliances
  • Non Compliance:View History
  • Non Compliance:View Non Compliance
  • Non Compliance:View Root Causes

NEXT STEP: Raising a New Non Compliance
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