Non-conformance - Implementation

Prerequisites

Your system is supplied with a predefined set of 'actions' and 'transaction types' commonly used by businesses in the distribution and manufacturing sectors. The list of actions (business processes) is defined in Miscellaneous table 806 - Actions; the list of transaction types is defined in Miscellaneous table 807 - Transaction type. You should review the lists in these Miscellaneous tables. Add to the lists if necessary and deactivate (by clearing the Active check box) the codes you do not require. The lists ultimately should reflect 'processes' common to preventing or correcting non-conformances in your particular business.

 You can add to the predefined 'actions' and 'transaction types' to suit your organization but do not modify or deactivate those which are in use.

Having set up Miscellaneous tables 806 and 807 you must match, or link, business process with transaction types using the Actions (GESNCSA) function. The 'actions' will be used during the Planning phase of the corrective and preventive cycle.

 Actions

You are also advised to review the values in the Miscellaneous tables listed in Other prerequisites and add to the values if required. Do not amend or delete the Local menus.

 Other prerequisites

Activity codes

The following activity codes (sorted by type) may have an impact on the way the function operates :

 ECC : Product version management

 NCS : Non-conformance

General parameters

The following general parameters may change the way the function is working :

Common Data

 NCSAPPROVE (defined at level User) : Approver

 NCSDEL (defined at level Site) : Delete non-conformance

 NCSDOCCHG (defined at level Site) : Linked document changes

 NCSDOCCRE (defined at level User) : Non-conformance creation mode

 NCSMULTIWO (defined at level Site) : Link prod tracking multiple WO

 NCSPLADEF (defined at level Site) : Default planner

 NCSPLANNER (defined at level User) : Planner

 NCSQADEF (defined at level Site) : Default QA manager

 NCSQAMAN (defined at level User) : QA manager

It is not mandatory to update the Site level parameters.

Sequence numbers

The sequence numbers used to number the documents managed by this function are :

 NCSRE : Non-conformance

The sequence number assignment function defines the sequence number which is used

Authorizations

This function is object managed. The creation, modification, anddeletion operations can be activated or deactivated for a given user.Filters by rolescan also be associated with this function.

As data is linked to a site, a filter per site can be activated.

Users

All employees that are permitted to be involved in your Non-conformance management (NCS) process must have an active User record (Users (GESAUS)).

Visibility of and access to non-conformance incidents is controlled using the standard user profile and access functionality:

• Access to a non-conformance incident is controlled using the user’s profile. Their profile is defined in the General block on their user record and controlled through the permissions defined for their profile code (Function profile (GESAFT)).
   Users assigned to a QA manager role and users that require unrestricted visibility and access to non-conformance incidents should have administrator rights.
• Access to specific roles in your Non-conformance management process is controlled through parameters. Roles are assigned and approved in the Parameters block on the user record (chapter TC, group NCS) and optionally at Site level using the Site level parameters.
   You can set up a default QA manager and Planner for each site and folder.
• The user’s functional profile also controls their site access and therefore the individual non-conformance incidents visible to them.
  You must ensure your users have site access for Non-conformance if you restrict your users’ access by site. Site authorization is defined using the Functional authorization (GESAFP) function for the function code GESNCSH (Non-conformance).
  With site authorization set up, visibility of and access to individual non-conformance incidents will be determined by the Site field on the non-conformance incident – the users assigned to the NCS roles above must have a profile code which has approval for the defined site.
• The user’s menu profile must provide access to the Non-conformances functions appropriate to their role in your NCS process.

Other prerequisites

Miscellaneous tables

The following miscellaneous tables are used by the function. They must be populated if necessary :

 Miscellaneous table number 802 : Reasons for Non-conformance

 Miscellaneous table number 803 : Root cause

 Miscellaneous table number 804 : Probable cause

 Miscellaneous table number 805 : Plan action type

 Miscellaneous table number 806 : Actions

 Miscellaneous table number 807 : Transaction type

 Miscellaneous table number 808 : Reason for rejection

Local menus

The following parameterizable local menus are used by the function. Their content must be updated if necessary :

 Local menu number 2030 : Severity level

 Local menu number 2031 : Product version impact

 Local menu number 2033 : Change status

 Local menu number 2041 : Approval status

 Local menu number 2042 : Closed status

 Local menu number 2045 : Plan status

 Local menu number 3703 : Non-conformance creation mode

 Local menu number 3715 : Origin

 Local menu number 3718 : Document type

 Local menu number 3719 : Line status

Miscellaneous tables: You can add lines to all miscellaneous tables listed above. Click the Active check box to activate a new line. To deactivate a code if the line has not been used in an incidence of non-conformance, clear the check box.

 Miscellaneous table 807 - Transaction type. Do not amend the existing values in this table. If your organization requires additional transaction types for approvers (subject matter experts assigned to review and confirm an incidence of non-conformance) or action plans you can add new codes and descriptions.

 Local menus: Do not amend or delete the existing values in the Local menus.

Tables used

The following tables are implemented by the function :