Non-conformance

Recommended approach to Sage X3 Non-conformance management

It is generally regarded as good practice to schedule regular meetings to review quality systems, procedures and regulations. Whether for changes to trends in sources of product and quality information or data information systems, these should include a formal review of results, risk analysis discussions and to sign off procedures. 

 The Sage X3 Non-conformance management functionality assumes this process is taking place in your organization.


The Non-conformance function is the central function for managing incidents of non-conformance. It controls every stage of the "corrective and preventive" process within the context of a "problem" or "defect", such as a failure or potential failure in a design or production model, or in a service, or in a process, or in the system. From the initial raising of a non-conformance incident through to the conclusion or successful resolution of a "problem" it manages business risk at every stage in making your product or process "fit for purpose". 

Quality control is a critical aspect of the development of a product and for the ongoing maintenance of a product. You can use this function to create (or report) incidents of non-conformance, or manage reported incidents of non-conformance created directly from an associated transaction such as a purchase receipt. Your quality procedures might indicate a design or production model does not comply with specifications or a defect in a purchased component is observed. You use the Non-conformance function to gather the critical information, including "in-flight" (cold call) information into one central repository. The non-conformance incident forms the details of the non-conformity or problem; it becomes the source of the information to support investigations into the root cause, or failure.

 All registered Sage X3 users can create non-conformance incidents.

Having created the initial incident the Non-conformance function then uses standardized procedures to enable efficient handling of subsequent corrective and preventive procedures:

  • Key personnel can be assigned to the incident that can challenge and determine if a problem has been identified. They can record findings from their root cause analysis. These personnel will also be able to provide input for any corrective actions.
  • It provides visibility of all proposed corrective and preventive actions.
    Personnel authorized for involvement in your "corrective and preventive" process can ensure the technical impact of the corrective and preventive actions are quality tested and approved. With easy access to data and the critical information needed to support the corrective and preventive actions, business risk is managed and minimized.
  • The corrective and preventive actions can be adapted where necessary to respond to changing business requirements or further root cause analysis. Unauthorized or unintended deviations can be prevented.
  • The approach to be taken to deliver the corrective or preventive actions, and therefore to eliminate the cause of the problem can be outlined.

You use the Non-conformance function, therefore, to manage your end to end "corrective and preventive" processes in full. When combined with regular review meetings (see Recommended approach to Sage X3 Non-conformance management above) it provides a highly effective and efficient control mechanism in making your products or processes "fit for purpose".

 A non-conformance incident can only be deleted if the NCSDEL–Delete non-conformance parameter (TC chapter, NCS group) is set to Yes and the non-conformance is at status New. Otherwise it needs to remain on file for audit purposes.

Prerequisites

SEEREFERTTO Refer to documentation Implementation

Screen management

The Non-conformance function contains a Home section and one section per feature of the corrective and preventive process:

  • Home section. The Home section provides key tracking information. It contains the key field – Status – which indicates the current stage of this non-conformance incident in the corrective and preventive cycle. You can pin this section so that it does not scroll off the page.
  • Identification. This is the main section for this function. You use it to articulate the details of the reported, or observed non-conformity. It is critical to the root cause analysis.
  • Review. Use this section to support root cause analysis. The information you add to this block is critical to the success of this incident. It will be used when defining the corrective and preventive actions required to eliminate the root cause or failure.
  • Rejection. This section is used by the QA manager for this non-conformance incident when this incident is formally rejected. Access to the fields is controlled by the Status field in the Home section.
  • Close. This section provides closure information for this non-conformance incident.
  • Reported by. Use this section to provide contact information for reporters (or sources) of this non-conformity.

Header

The Home section provides key tracking information. You can pin this section so that it does not scroll off the page.

The critical field in the Home section is the Status field. This field indicates the current stage of this incidence of non-conformance in the corrective or preventive cycle.

If this non-conformance was created directly from a particular transaction such as a purchase receipt or customer return, many fields in this section will be populated from that transaction document. You can leave the default values or change them.

You can identify a specific supplier or customer as the source of this incident, effectively implying this non-conformance is specific to them. Alternatively, you might decide that this non-conformance could affect multiple suppliers, customers or individuals (internal or external). Should this be the case you should leave the supplier/customer in this section blank and instead add multiple "reporters" directly into the Reported by section.

An incidence of non-conformance can apply to a specific product, or a system or non-stock item such as documentation, procedure or training. If a product is version managed you can add an additional level of detail by specifying which major and minor version this incident is for.

This section displays the name of the person who created this incidence of non-conformance and when they created it.

 Note the following rules if you intend to add (link) a document from an associated transaction to support this incidence of non-conformance:

  • If the Product field contains a product code you can only link a document for that product.
  • If the Supplier or Customer field contains a supplier/customer code they are the original source or reporter of this incident. You can only link a document associated with the defined supplier or customer. For example, if a particular supplier is specified in the Supplier field you can only link a document such as a purchase receipt for that supplier.

 There can be multiple non-conformance incidents per product code.

Quality assurance (QA) managers

As the QA manager for this incidence of non-conformance you ultimately have full control over this incident and the progress of it through the corrective or preventive cycle. To advance or reverse the status of this non-conformance you need to be logged in as the current QA manager for this incident.

Tab Identification

Reporting a non-conformity for a "problem" or "defect", or failure or potential failure in a design or production model, or in a service, or in a process, or in the system is critical for delivering a product that is "fit for purpose". You use this section to articulate the details of the non-conformity.

  • You can attach an image (such as a photograph) of the problem.
    You can provide an image for both a product-related incident and a non-product-related incident (process).
     You can use the Attachments icon on the Side bar to attach multiple images; if you do not want to display images you can remove the Image block using the Customize screen functionality provided with your solution.
  • You can identify the probable or possible cause of the incident.
  • The key element of the reported incident is a statement that describes the "problem" or failure in detail. You should try to quantify the suggested value for the probable cause and list several reasons why. This will help you ensure you have thought about all the possible causes.
    You can provide this statement in a free-format narrative field.
    Your list of reasons will assist the Quality control team in trying to track down the root cause of the incident. If you can explain the potential consequences if the problem or failure is not addressed, and provide a clear request for corrective or preventive action, this will also help. Ultimately, your statement is critical to the Quality control team for analyzing whether the design or production model complies with the set standard and can be considered "fit for purpose".

You also use this section to link to and view actual documents the observed problem has been reported against.

If this non-conformance was created directly from an associated transaction such as a purchase receipt its details are displayed in the Source documents block. A QA manager can manually add documents to this block to link the document with any in-progress non-conformance incident, that is at status In review, In planning, or Being implemented. Once linked, quantities can be changed, and documents activated and deactivated.

Where a linked document is from a production tracking operation the default product code is the first released product on a work order. The product code can therefore be changed to any product code associated with the work order while the non-conformance incident is at status New. This might be to a different released product code on the work order or to the routing product code if different to the released product code. The product code in the linked document line is also changed to the new non-conformance product code.

 Linking documents, activating or deactivating documents, or amending the quantity from the source document or order line is blocked if the NCSDOCCHG–Linked document change parameter is set to No, the status of a non-conformance is Being implemented and the corrective and preventive Action plan is being implemented (actioned).

 Note the following rules if adding a document to the Source documents block:

  • You can only select a transaction for the defined product if the Product field in the Home section contains a product code.
  • You can only select a transaction associated with the supplier or customer identified as the original source or reporter of this incident if the Supplier or Customer field in the Home section contains a supplier/customer code.
  • Production tracking documents need to be for a single (the same) work order if the first linked document (that is, the first document line) is a production tracking document and the NCSMULTIWO–Link prod tracking multiple WO parameter (TC chapter, NCS group) is set to No.

Tab Review

You use this section to support root cause analysis. It contains two blocks:

  • The Cause block is used to identify the single root cause of this incident.
     If as a result of the root cause analysis more than one cause is determined you could consider raising additional non-conformances to address each root cause. Each root cause will then be corrected or prevented with an individual Action plan.
  • Within this block the likely impact of this defect and the urgency of correcting or preventing it can be defined.
  • As any identified "change" needs to be managed through the critical checkpoints to the conclusion, or closure of it you use this block to assign this incident to the default, or an appropriate "QA manager". A QA manager is a subject matter expert with the authority to approve or reject any suggested changes. They might be a member of your organization’s Quality control team, such as a development manager or a test lead. Alternatively, they might be a product manager that assesses products for market suitability.
    You can reassign this incident to a different QA manager if, and when necessary.
  • You can also assign the default, or an appropriate "planner" (project manager) to be responsible for managing the "change".
    A different planner can be assigned to this non-conformance if, and when necessary.
  • The Approvers block is used to assign personnel to this incident that can challenge and determine if a problem has been identified.


The information added to this section is critical to the success of this incident. It will be used when defining the corrective and preventive actions required to eliminate the root cause or failure.

If you are the QA manager for this non-conformance or a subject matter expert that has been assigned to support investigations into the root cause, or failure, you provide your feedback in this section; if you are a stakeholder or member of your company's Quality control team or steering committee, you can use this section to view post-review decisions or conclusions.

QA managers

As the QA manager for this non-conformance incident you use the Approvers block to identify subject matter experts that have the expertise to review and confirm this incidence of non-conformance. They might be, for example, a member of your organization's Quality control team.

You can assign "approvers" to analyze the root cause of this incident and "approvers" that have the skills to confirm quality processes and standards have been followed in making a product or system "fit for purpose". Your approvers should have the skills to approve or reject the suggested incident for an assigned area of expertise.

Tip: Use the Assigned as QA manager filter to locate your non-conformances quickly and easily.

 As approvers have authority to approve or reject this incident it is important that you give due consideration to which subject matter experts you assign.

 Your organization's Quality control team should consider the point at which the decision to approve or reject this incident is made. Essentially, at which stage in the review process you should manually advance this non-conformance to either status In planning or to status Rejected.

  • You can only assign "approvers" to this non-conformance while it is at status In review.
  • As the QA manager for this non-conformance you are the only user authorized to assign "approvers" to it.
  • "Approvers" need to be authorized Non-conformance management subject matter experts.
  • You can associate multiple "approvers" with this non-conformance.
  • You can associate a single "approver" with multiple transaction types.
  • You do not have authorization to set the approvers post-review decisions.
  • You are responsible for manually advancing this non-conformance to selected stages in the corrective and preventive cycle.
  • Having a complete set of approver post-review decisions is a not a prerequisite to changing the status of this non-conformance.

Approvers

As an "approver" you have been assessed as having the expertise to review and confirm an incidence of non-conformance.

You should try to identify the root cause of this incident from the transaction types assigned to you.

Having determined or identified if a problem exists or not you notify the QA manager for this non-conformance and the stakeholders by setting a post-review decision against each transaction type. One comment field per transaction type is available to you which you could use to quantify your decision. You could use it, for example, to state assumptions or make recommendations to the Planner (project manager) responsible for planning the corrective and preventive actions. The QA manager cannot set your approval status or add comments on your behalf.

Tip: Use the My non-conformances to approve filter to locate your non-conformances quickly and easily.

 

  • You need to meet the following conditions to be able to update your assigned transaction type:
    • You need to be logged into Sage X3 with your user name.
    • You need to have approval for involvement in your company's Non-conformance management process as an approver, that is, your NCSAPPROVE–Approver user parameter (TC chapter, NCS group) is set to Yes.
  • If site restrictions are in place, visibility of and access to this non-conformance is determined by the value of the Site field.
  • You can only set an "approval status" while this non-conformance is at status In review.
  • Your post-review decisions are not a prerequisite to the status of this non-conformance being changed.
  • The QA manager is not permitted to set your post-review decisions or add comments on your behalf.

Tab Rejection

This section is used by the QA manager for this non-conformance incident. If you are a stakeholder or member of your company's "change board" or steering committee, you can use it to view the formal rejection reason and conclusions.

 This non-conformance can only be rejected by the QA manager assigned to it.

QA managers

As the QA manager for this non-conformance, you use this section to formally reject this incident. This is mandatory if the Quality control team conclude there is no problem and the product or solution is "fit for purpose". You might also choose to reject it if it has been created in error or is a duplicate of another non-conformance incident.

This non-conformance needs to be at status Rejected for the fields in this section to be available for entry. As a minimum, you need to define the reason the Quality control team is formally rejecting this non-conformance.

You can expand upon the reason for rejection in a free-format narrative field.

Tip: Use the Assigned as QA manager filter to locate your non-conformances quickly and easily.

  • You can only set a rejection reason if this non-conformance is at status Rejected.
  • As the QA manager for this non-conformance you are the only user authorized to reject it.
  • Having all approver post-review decisions at status Rejected is a not a prerequisite to the status of this non-conformance being set to Rejected.

 You will lose all information in this section if you subsequently revert the status of this non-conformance to status In review.

Tab Close

This section is updated when you close this non-conformance incident. It states who closed this incident and when it was closed.

There is a free-format narrative field which supports the reason for closure if it was completed when this incident was formally closed (using the Close action).

Tab Reported by

You use this section to provide contact information for a reporter (or source) of this incidence of non-conformance. Any individual (internal or external), customer or supplier that has identified a "problem" or "defect", or failure or potential failure in a design or production model, or service, or process, or system can report it and be recorded as a reporter of it.

If you specify a customer or supplier in the Home section they are regarded as the source of this reported non-conformance. Their details will be displayed on the first line of the appropriate table (grid) in the respective Supplier/Customer block. Otherwise you are advised to provide the name and contact details for at least one source of the information at some stage in the corrective and preventive cycle. This will ensure someone with knowledge of the incident is contactable should investigations or quality tests need clarification at any stage of the processing cycle.

 The origin or source of an incidence of non-conformance is essential should further explanation be required or questions need answering. It might be difficult to obtain this information without the name and contact details for at least one source.

Examples of a source of an incidence of non-conformance might be:

  • A product manager that has identified a potential stress test failure in your company’s line of business
  • A customer that has identified a failure in a product when used under specific conditions
  • A network engineer that has identified lack of capacity in a device
  • A service manager that has identified the failure of your company’s vendor contracts to meet agreed delivery times
  • A Tier 1, 2, or 3 support engineer that has identified a defective part in a network element
  • A security manager responding to a newly discovered vulnerability

 All registered Sage X3 users can add contact details to any new or "in progress" non-conformance incident.

Reports

By default, the following reports are associated with this function :

  NCSRECENT : List of non-conformances

This can be changed using a different setup.

Specific actions

Limitations

 Product or safety recalls. You should only use the information in this non-conformance as a guide when a product or safety recall is advisable. Each country has safety regulations and directives for recalls which you must follow. These regulations have not been implemented in the Non-conformance functionality as they can vary from one country to another.

Error messages

In addition to the generic error messages, the following messages can appear during the entry :

Supplier can be blank or enter $1$.
or
Customer can be blank or enter $1$.

Entry of a supplier or customer code is optional. There are two locations in which you can report a supplier or customer as a reporter (or source) of a non-conformance: In the Home section and in the Reported by section. The Supplier (NCSBPS field) or field in the Home section is only available for entry if the Origin field (NCSCATEGOR) is set to Supplier, Internal, or External; the Customer field (NCSBPC) if the Origin field is set to Customer, Internal, or External. If you do not know the supplier/customer code leave the field blank. In the Reported by section you use the respective Supplier field (BPSNUM)/Customer field (BPCNUM).

The Reason field must contain a value
or
The Severity field must contain a value
or
The impact field must contain a value

Why are you raising this Non-conformance? How significant is this defect likely to be? Please select an appropriate value for this field to ensure the appropriate "quality" team can be assigned to investigate the root cause, or failure.

The general parameter NCSQADEF needs to contain a value
or
User $1$ is not a QA Manager – see user parameter NCSQAMAN
or
User $1$ is the default QA Manager – see parameter NCSQADEF

Where $1$ = Sage X3 user code. Each non-conformance record needs to have a nominated Quality assurance (QA) manager (QA manager field). A QA manager is an active Sage X3 user who has been authorized to perform that particular role within your Non-conformance management process. This means that the Active checkbox on their Sage X3 user record is selected and their "QA manager" approval parameter NCSQAMAN–QA manager (TC chapter, NCS group) is Yes. One "QA manager" user should be nominated as the default QA manager for all new reported incidents of non-conformance. You define the default QA manager by adding their Sage X3 user code to the folder or site level NCSQADEF–Default QA manager parameter (TC chapter, NCS group) – but only after their user parameter has been set.

Please enter Non-conformance Planner
or
User $1$ is not a Planner – see user parameter NCSPLANNER
or
User $1$ is the default Planner – see parameter NCSPLADEF
or
No default QA Manager – see parameter NCSQADEF

Where $1$ = Sage X3 user code. Each non-conformance record needs to have a nominated Planner (Planner field). A Planner (or project manager) is an active Sage X3 user who has been authorized to perform that particular role within your Non-conformance management process. This means that the Active checkbox on their User record is selected and their "Planner" approval parameter NCSPLANNER–Planner (TC chapter, NCS group) is Yes. One "planner" user should be nominated as the default planner for all new reported incidents of non-conformance. You define the default planner by adding their user code to the folder or site level NCSPLADEF–Default planner parameter (TC chapter, NCS group) – but only after their user parameter has been set.

User $1$ is not an Approver for Non-conformance
or
The same transaction type for the same approver cannot be entered several times.

Where $1$ = Sage X3 user code. You can assign Sage X3 users as subject matter experts, or "approvers" to review and confirm an incidence of non-conformance. The Sage X3 user code selected is invalid. This might be because they are not an active Sage X3 user or because they have not been authorized for the particular Non-conformance management role you tried to assign them to. Although you can associate multiple "approvers" and multiple transaction types with a single non-conformance, you can only associate a single "approver" with a single transaction type.
 Parameters

You can only proceed if you are the QA manager for this Non-conformance record and the status is In review

You can only change the status of this non-conformance if you are the assigned QA manager.

Existing plan will be removed. Are you sure you want to continue ?

You can revert a non-conformance from status In planning to status In review. If you confirm your action the system automatically deletes the corrective and preventive Action plan. Are you sure you want to do this?

Non-conformance status is not valid.

A non-conformance is status driven (New > In review > In planning > Being implemented > Completed > Close). You have attempted to change to a status that is not a preceding, or the next status in the corrective and preventive cycle. Additionally, some statuses (status In planning, Being implemented, Completed) are directly linked with the status of the Action plan. This can lock (prevent changes to) the non-conformance while the Action plan is in progress.

$1$ is not a contact for $2$

Where $1$ = Contact within selected customer or supplier organization; $2$ = Customer/Supplier. You can only add a contact that is associated with the selected customer or supplier.

The Reason for rejection field must contain a value

Why are you rejecting this incidence of non-conformance? Select the reason in the Reason for rejection field (REJECTCOD) to ensure the decision made by the Quality team is recorded formally. You are advised to expand upon the selected reason in the Additional information field (REJDESC).

Duplicate Originator is not allowed.

This incidence of non-conformance has already been reported for the defined product code by this source (supplier, customer, internal user, external contact).

No valid document line.

This message is displayed if an internal link to the attached document line has failed. Check if the defined line on the attached document still exists. It might have been deleted.

Split receipt line selection not allowed.

This message is displayed if the attached transaction line is a purchase receipt line that has been split. That is, the original order quantity has been received in multiple deliveries or it has been distributed to multiple warehouses. You cannot specify a split receipt line. You could link this non-conformance to the transaction header instead of the transaction line.

You can only deactivate this user when all non-conformances to which they have been assigned are closed.

A Sage X3 user can only be deactivated from a specific Non-conformance role if all non-conformance incidents to which they have been assigned are closed.

Modifying this document may create discrepancies in the Non-conformances.

Documents can be linked to incidents of non-conformance from a linked function such as Purchase receipts when a non-conformity is observed, or added to a non-conformance incident manually. Once linked, non-conformance quantities can be changed and documents activated, and deactivated. Changing the source document, however, does not change the non-conformance information potentially leading to discrepancies between the two sets of information (the source document and the non-conformance).

Deleting this document does not delete the Non-conformances.

Deleting a document linked to a non-conformance does not delete the non-conformance. A non-conformance incident can only be deleted if the NCSDEL–Delete non-conformance parameter (TC chapter, NCS group) is set to Yes and the non-conformance is at status New.

Non-conformance $1$ does not exist.
or
Unknown error occurred while creating a Non-conformance.
or
Unknown error occurred while updating a Non-conformance.

Where $1$ = Non-conformance ID (NCSID field). This message is displayed if an internal link in the system has failed and it is not able to access the non-conformance incident selected. If a second attempt to access the non-conformance incident fails and the error is redisplayed you should contact your system administrator.

This Non-conformance is now closed. Amendment is forbidden.

No changes are permitted at all once a non-conformance is closed.

You can only deactivate this user when all Non-conformance to which they have been assigned are closed.

A Sage X3 user can only be deactivated from a specific Non-conformance role if all non-conformance incidents to which they have been assigned are closed.

Tables used

SEEREFERTTO Refer to documentation Implementation