Implementation Considerations

This chapter covers the following topics:

Implementing Nonconformance and Disposition Solution

This chapter contains general implementation considerations for the Nonconformance and Disposition solution.

The Nonconformance and Disposition solution is based on a set of related collection plans that store nonconformance and disposition related information. Implementation of the solution templates aid in the process of satisfying the requirements of some international quality standards, listed below:

The nonconformance and disposition records are created, updated, and copied across plans throughout the lifecycle, by various participants within the business process. Notifications are sent to responsible parties to ensure that appropriate actions are taken. Some of the disposition execution can be automated. A predefined list of values is provided to ensure the validity of data.

This implementation guide provides you with the most generic nonconformance and disposition business flow. Your specific nonconformance and disposition business processes can be different from the generic business flow. This solution is flexible and easily extensible, and can be tailored to suit your specific business needs. The following sections describe some of the factors that need to be considered before implementation.

What are the benefits of a transition from a paper based nonconformance and disposition system?

The basic premise of the solution templates provides a central repository for all the nonconformances and dispositions information, within an organization. By implementing the solution templates, you have the following advantages:

How will the solution template help your enterprise transition from stand-alone legacy systems?

If you are using different disparate, non-integrated systems to track nonconformances, as mentioned earlier, the solution templates aid to centrally maintain this information, In addition to using Oracle Quality, other integrations available within the e-Business Suite will help you to track nonconformances at different points within the supply chain.

What are the different types of nonconformances logged in your enterprise?

Depending on the type of business and industry you are in, the nonconformances reported in your enterprise might be at different points within the supply chain. To address all the likely functional areas that may generate a nonconformance, the solution has been designed to accept inputs from different sources.

Some functional areas where nonconformance occurs are identified below:

Nonconformances logged from all sources are stored in a central repository titled, Nonconformance Master.

Due to the tight integration of Oracle Quality with other modules within the Oracle eBusiness Suite, it is possible to record nonconformances during inspection or other transaction that are currently supported. Please refer to Setup Steps.

What type of data will be captured for nonconformance and disposition?

The Nonconformance and Disposition solution provides data collection capability to capture data for nonconformance, disposition, and associated quality results. Depending on your current business process, as well as your required level of detail, a choice can be made between the three different configurations:

Configuration Details and Usage Parent Plan
Nonconformance and Disposition
(recommended configuration)
This configuration has all the collection plans and seeded data for implementing Nonconformance and Disposition Management (the master set of the next two configurations) Template Nonconformance Master Plan
Disposition Only This configuration consists of all collection plans and related seeded data used for Disposition Management only.
Use this configuration if your business tracks disposition only and would like to take advantage of the automatic disposition transaction execution capability.
Template Disposition Header Plan (Disposition Only)
Nonconformance Only This configuration consists of all collection plans and related seeded data used for Nonconformance Management only.
Use this configuration if your business does not require a systematic way of tracking disposition.
Template Nonconformance Master Plan (Nonconformance only)

Additional data could be captured in user-defined collection elements and added to these collection plans. See: Setup Steps, Step 9.

Alternatively, these elements can be grouped into additional plans and linked to the nonconformance/disposition system. See: Setup Steps, Step 10.

What needs to be done after a configuration is chosen?

Once the decision on which configuration is suited for your enterprise has been made, the next step is to copy the template plans, associated with the specific configuration, to real plans. The template plans have collection elements, actions, and parent-child relationships that have already been defined.

A tool is provided to copy this set of template collection plans to real plans. See: Setup Steps, Step 2. You can choose to copy from the template collection plans, tailor these to your business needs, and make these a reference set of plans for your implementation. See: Considerations Prior to Implementation.

How is the nonconformance and disposition information organized?

All the necessary data elements required for the nonconformance and disposition lifecycle can be captured at different levels in the parent-child collection plan structure. Depending on the granularity of information that your business process requires you to capture, the different levels might or might not be applicable to you.

The following block diagram displays a simplified version of the nonconformance and disposition data structure. Following are the assumptions for this structure:

If your business organizes information in a simplified fashion, you can remove any level (collection plan) that is unnecessary. See: Setup Steps, Step 13.

How are Nonconformances and Disposition identified?

The current practice in your enterprise might require you to track Nonconformance and Disposition using standard operating procedures. In this solution, nonconformances and dispositions are identified using two collection elements: Nonconformance Number and Disposition Number. These are Sequence type collection elements and have specific attributes associated.

These attributes can be customized to match the naming convention used in your enterprise. See: Setup Steps, Step 3.

Who has privileges to access Nonconformances and Disposition information?

In any system that tracks nonconformances and dispositions, it is important to limit access to authorized individuals, due to information sensitivity. Once the information is accessed, the type of operations enabled for the user needs to be considered. You can utilize collection plan security to achieve this.

Different participants of the process can be given different privileges (create, update, view) to access different sets of information. In this manner, careful administration of user privileges is collection plan security. See: Setup Steps, Step 8.

How are user entered values validated?

New collection elements with a set of values have been provided as a starting point to record nonconformances and dispositions. The solution has included commonly used values for validation of some collection elements, listed below:

These values can be modified to your valid values, according to your business rules. See: Setup Steps, Step 4.

How are individuals informed about a nonconformance or disposition?

In this solution, e-mail alert and workflow notification capabilities have been provided. Depending on the prevalent practice in your organization, either one or both can be used to inform, update, and adding individuals to specific tasks during the nonconformance and disposition lifecycle. Optionally, the e-mail alerts can be sent to mailing lists, or people outside of your organization, such as suppliers, customers, etc. They can also be sent to mobile devices.

How do you implement the Material Review Board process?

Traditionally, when a material nonconformance is logged, depending on the business process in that industry or specific organization, the nonconformance is reviewed by a group of authorized individuals who determine how the nonconforming material needs to be dispositioned. This process can involve discussions between representatives from different functional areas, such as Quality Assurance, Inventory, and Purchasing.

If your organization has a formal MRB process, it can be modeled using the nonconformance solution; discussion threads on the cause and analysis of the nonconformance can be carried out. Initially, the nonconformance owner assigned to a distribution list can be used to send e-mail alerts on the nonconformance. It is possible to include additional reviewers or approvers in an ad hoc manner, based on the progress of the nonconformance lifecycle.

In the following example, the modeling of MRB activities via the solution templates is highlighted. When a nonconformance needs to be reviewed by a group of people (MRB, for example), the Action and Notes related elements of the Nonconformance Detail plan can be utilized.

For example, the nonconformance owner wants to ask the Quality Engineer to perform certain analysis, he or she could enter a record into Nonconformance Details with the following values:

Action Executed By Nonconformance Owner
Next Action Type FOR ANALYSIS
Next Action Description Please perform XYZ analysis...
Next Action Assigned To Quality Engineer

This Quality Engineer has performed the analysis and requests a review by his manager by updating the same Nonconformance Detail:

Notes Detailed results of the analysis...
Action Executed ANALYSIS
Action Executed By Quality Engineer
Next Action Type FOR REVIEW
Next Action Description Please review this for analysis
Next Action Assigned To Quality Manager

The following screenshots illustrate how the Material Review process is handled using the Nonconformance and Disposition solution. All updates to these elements are captured in multiple history records of this parent record.

Nonconformance Detail Plan

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Nonconformance Detail History, viewed from Nonconformance Detail

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How is MRB Hold or segregation achieved?

When nonconforming material is found, if it is decided to put the material on hold and unavailable for use, the same can be achieved by segregation actions. The segregation actions supported are: Creation of a move order to move nonconforming material found during receiving inspection or in inventory to a MRB location and component return of a nonconforming component from WIP to a MRB subinventory. With these two segregation actions, the nonconforming material cannot be transacted until a decision on its disposition is made. The designated MRB subinventory should be defined with the appropriate parameters to make it non-nettable and not reservation enabled.

There are two segregation plans that are child plans to the Nonconformance Master. The can be used to execute these segregation actions.

How is an Audit Trail of Nonconformance and Disposition maintained?

All collection plans provided in the solution contain a History plan as one of the children. When these collection plans are used out-of-the-box after copying them to real collection plans, the history plan captures all updates made to any collection element in the parent plan. Therefore, from an auditing perspective, if it is required to display the details on all changes made to a nonconformance line, the same can be demonstrated.

If there are only some collection elements that need to be captured for audit trail purposes, then the parent-child copy relationship between the parent and child plans for the non-essential collection elements needs to be removed. If for compliance purposes, the audit trail needs to be reported, custom reports can be built to generate the same.

How do you link the Corrective Action system to the Nonconformance and Disposition system?

When logging a Corrective Action Request as part of your Nonconformance or Disposition process flow, the Corrective Action system can be linked to the collection plan corresponding to the step in your process. See: Setup Steps, Step 11.

How do you use attachments for nonconformance and dispositions?

The current functionality of adding attachments within the Enter Quality Results and Update Quality Results windows is applicable to nonconformance and disposition. When logging a nonconformance, it might be required to attach pictures of the nonconforming material. In the case of dispositions, such as rework, additional instructions can be provided by drawing attachments.

In addition, for the disposition actions of creating a rework job or adding a rework operation, when attachments (for work instructions) are added at the line level of the respective disposition action, the attachments will be copied to the newly created rework job and operations. This facilitates the personnel to review the work instructions when performing a re-work.

How do you maintain a link between multiple nonconformances?

To illustrate how to link multiple nonconformances, two scenarios are used. In the first case, a nonconformance is logged for an assembly and it is later found that the actual nonconformance is because of a component in the assembly. This can be modeled in the following manner:

The collection plans, Nonconformance Master and Nonconformance Details have a collection element, Nonconform Item Type. The initial values available for this element are Assembly and Component. When the nonconformance is logged in the Nonconformance Master, the Nonconform Item Type can be entered as Assembly with the item number in the item collection element. When it is later determined that the cause of the nonconformance is the component, the Nonconform Item Type can be updated to the component with the relevant item number. Because history for the nonconformance is captured, it is possible to trace back and infer that the initial nonconformance was for the assembly and then it later became a component nonconformance.

In the second case, a nonconformance is logged for a finished product. Initial analysis reveals that it is an assembly problem. The Nonconform Item Type can be used to specify that the assembly caused the nonconformance. Additional investigation by disassembling the finished product reveals that there are multiple components in the assembly nonconforming. A nonconformance can be logged for each nonconforming component.

To maintain an association with the original nonconformance, you can create a new collection element, Parent Nonconformance, of character data type, and add the element to the Nonconformance Master and/or Details plan. When a new nonconformance is logged for each nonconforming component, a unique nonconformance number is generated. The Parent Nonconformance element can be used to maintain a link with the original nonconformance. Later, if all nonconformances for a specific parent nonconformance is required to be reported, the parent nonconformance number can be used as the query criterion to find all nonconformances. See: Reporting Overview.

How do you capture nonconformance and disposition costs?

The following steps can be performed:

Implementation Roadmap

The following process flow illustrates a generic nonconformance and disposition lifecycle:

Simplified Flow for Nonconformance Management

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Nonconformance and Disposition Lifecycle

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Each rectangle represents an action step in the business flow and corresponds to step(s) to be executed in the Oracle Quality Nonconformance Solution. The following table illustrates the business flow step and the equivalent step in the nonconformance and disposition solution. Additional details, based on the function area of the nonconformance, are provided in the remaining chapters.

Business Flow Steps Oracle Quality Nonconformance and Disposition Solution Steps
Log Nonconformance Enter a new record into the Nonconformance Master Collection Plan within Oracle Quality
Assign Owner Update Owner collection element in the Nonconformance Master
Segregate Nonconforming Material Enter information in the inventory or WIP segregation plan to segregate the material and move to a MRB or other quarantine subinventory
Review Nonconformance Update elements such as Priority and Severity in the Nonconformance Master
Enter a new record into the Nonconformance Detail (child collection plan of Nonconformance Master) to capture additional details and notes
Update elements such as Notes and Action in the Nonconformance Detail
Approve Nonconformance Update Action Executed to Approval in the Nonconformance Detail
(Customized workflows can also be used to achieve approvals, based on approval hierarchy)
Record Disposition Enter a new record in Disposition Header to describe the Disposition
Enter one or more records in the Disposition Detail (child plan of Disposition Header) to indicate the Disposition Action(s)
Disposition Implementation Enter one or more records in the Disposition Implementation collection plan for the corresponding functional area (In-Process, Inventory)
Close Disposition Update Status element to Closed in Disposition Implementation, Disposition Detail, and Disposition Header plans
Close Nonconformance Update Status element to Closed in Nonconformance Detail and Nonconformance Master plans

Implementation Checklist

The implementation might span multiple functional areas. The following list provides information on the process flow and steps to implement within these functional areas: