Implementation Roadmap

This chapter covers the following topics:

Overview of Implementation Roadmap

This chapter provides the guidance needed to implement the Corrective Action Solution. After the implementation of the Corrective Action Solution, the Corrective Action collection plans will contain all information related to problems requiring corrective action reported within your enterprise, and subsequent review and implementation of those corrective actions.

Implementation Considerations

You can identify factors that need to be considered, prior to setting up and implementing the Corrective Action Solution. Depending on your specific business processes, these factors may or may not be applicable.

This section includes the following topics:


Following are the prerequisites needed to implement the solution:

Corrective Action Request Types

It is important to consider the types of Corrective Action Requests that are commonly handled by your organization, and the types that will be implemented in the Corrective Action Solution.

Based on the origin of the CAR within the Supply Chain, there can be different types of requests. The responsibility for the action might lie with different parties. We will assume Supplier S supplies material and services to Enterprise E who in turn sells products to Customer C.

You can enter request types using the solution template collection plans. The solution includes seeded values for request types. The Corrective Action Requests (CARs) can be categorized into the following types:

Internal CAR

This CAR category is primarily associated with resolving problems within Enterprise E. Examples of these problems are poor quality due to non-adherence to quality procedures, and recurring physical damage to assembly during handling and storage.

CAR requiring Supplier Action

This CAR category originates from the supplier. Examples of these are related rejections of supplier lots received from Supplier S in the receiving integration.

Customer Initiated CAR

This CAR category is initiated by a customer to address problems from their suppliers, within the Supply Chain. For example, Customer C logs a CAR with Enterprise E to identify the reason recent shipments from Enterprise E have labels that do not match their contents.

Internal CAR that eventually requires Supplier Action

This CAR category is associated with problems that were initially thought to be internal issues, but further analysis identified them as a supplier problem.

Customer initiated CAR that requires Supplier Action

This CAR category is an extension of the previous category. The customer initiates a CAR, but further evaluation and analysis identifies the cause as supplier related.

Corrective Action Request Sources

Corrective Action Requests can originate either from customer complaints, nonconformance trends, quality audits, or other sources. Following are some of the factors that need to be considered before you implement the Corrective Action Solution:

Captured Data

Oracle Quality provides a data collection capability within Collection Plans; they can capture all data involved in your business process, including Corrective Action and related Quality test results.

Additional data not covered by the template collection plans can be captured in user-defined collection elements, and added to collection plans.

Alternatively, these elements can be grouped into additional plans and linked to the nonconformance/disposition system.

Valid Values

The solution has included commonly used values for validation of some collection elements. These values can be modified to your valid values, according to your business rules. Some of these elements are listed below:

Corrective Action Identification

Corrective Action is identified by sequence numbers. Your business may use a prefix/suffix for identification purposes; the corrective action number can be customized.

Corrective Action Data Privileges

Different participants of the process can be given different privileges (new record, update record, read only) to access different sets of data. You can enforce collection plan security.

Corrective Action Process

This section includes a look at the corrective action process flow and maps the business flow to Oracle Quality.

Corrective Action Process Flow

The following process flow illustrates a generic Corrective Action Request lifecycle. The actual process used in your organization may be different than what is depicted in the following diagram:

the picture is described in the document text

Some of the procedural steps taken during the lifecycle of a Corrective Action Request are described below:

Step 1 - Submitting a Corrective Action Request

Corrective Action Requests are a result of problems identified in the quality management system. They can originate internally, or as a result of a customer complaint, falling into one of the different request types. See: Corrective Action Request Types.

Step 2 - Request Review by Owner

The owner reviews the Corrective Action Request and either approves or rejects it. The criteria for approval or rejection depends on your organization's specific business processes.

Step 3 - Owner decides Course of Action

For Internal and Customer Initiated CARs, based on the problem description, the owner consults with other individuals, and decides on how to process the CAR. For a Supplier CAR, this step might not be required. The supplier is automatically responsible for providing a plan of corrective action.

Step 4 - Owner/Assignee Implements CAR Actions

After sufficient review and analysis has been performed by the individuals involved in the CAR lifecycle, decisions are made on the CAR actions (Containment, Corrective, Preventive Actions).

Step 5 - Owner Reviews CAR Lifecycle

After the corrective actions have been successfully implemented and the effectiveness of the implementation has been verified, the CAR's owner closes the CAR with appropriate comments.

Mapping the Business Flow to the Oracle Quality Step

The following table maps the business flow steps to the equivalent steps to be executed within Oracle Quality:

Business Flow Step Oracle Quality Step
Submit Corrective Action Request Invoke the Corrective Action Request collection plan within Oracle Quality and submit a CAR
Assign Owner Update Owner collection element in Corrective Action Request
Review Corrective Action Request Update elements (Priority, Severity, etc.) in the Corrective Action Request plan.
Assign CAR actions Owner determines the course of action and creates Review actions, assigning the same within the CAR Review plan
Owner determines the course of action and creates Implementation actions, assigning the same within the CAR Implementation plan
Analysis/Review by Assignee The assignees update the CAR Review plan with the Notes on the review actions that were performed, and the status of the review actions
Determine Root Cause Owner/Assignee determines the root cause and updates the CAR plans with the information
Implement Corrective Actions Assignees update the Corrective Action Implementation plans with the implementation actions, notes, resolution dates, and statuses of the actions
Verify implementation and its effectiveness Owner reviews the CAR and the child review and implementation plans to verify successful implementation. Additionally, the owner may set up a follow-up date to review implementation effectiveness
Inform necessary parties If required, owner informs the customer, supplier, or any other internal or third party, on CAR status via e-mail alerts
Close CAR Owner closes the CAR in the Corrective Action Request Plan

Implementation Checklist

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


Set Up

Corrective Action Implementation

Reporting and Tailoring your Solution