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 or business processes is defined in the 806–Actions miscellaneous table. The list of transaction types is defined in the 807–Transaction type miscellaneous table. Review the lists in these miscellaneous tables. Add to the lists if necessary and deactivate the codes you do not require by clearing the Active checkbox. The lists ultimately should reflect "processes" common to your particular business.

Having set up the 806 and 807 miscellaneous tables, you need to match or link business process with transaction types using the Actions (GESNCSA) function. The "actions" are 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 needed. 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, and deletion operations can be activated or deactivated for a given user. Filters by roles can 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 need to 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 need unrestricted visibility and access to non-conformance incidents need to 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 (TC chapter, NCS group) 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 need to 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 is determined by the Site field on the non-conformance incident–the users assigned to the NCS roles above need to have a profile code that has approval for the defined site.
• The user’s menu profile needs to 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 need to 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

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

Local menus

The following parameterizable local menus are used by the function. Their content needs to 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

Tables used

The following tables are implemented by the function:

Table	Table description
ATEXTRA [AXX]	Texts to translate
NCSADES [NCSADE]	Non-conformance description
NCSAPPROVER [NCSAPPR]	Non-conformance approvers
NCSBPC [NCSBPC]	Customers
NCSBPS [NCSBPS]	Suppliers
NCSDES [NCSDES]	Non-conformance description
NCSDOCHDR [NCSDHD]	Non-conformance documents
NCSDOCLIN [NCSDLN]	Non-conformance documents
NCSEXTUSR [NCSEU]	External user
NCSINTUSR [NCSIU]	Internal users
NCSRECENT [NCSRC]	Non-conformance
NCSREJDES [NCSREJ]	Rejection description