Understanding Quality Management

This topic provides the fundamentals of Quality Management. It presents the basic tasks, responsibilities, and process flow required to manage the quality of a product. An introduction to process quality management concepts, and the impact that quality has on other applications is provided.

This chapter covers the following topics:

About This Guide

The purpose of this guide is to provide reference information for end-level users of the Oracle Process Manufacturing (OPM) Quality Management application. It presents:

Depending on your system security profile, it is possible that you do not have access to all of the windows and functions described in this guide. If you do not see a menu option described, and you need to access it, then contact your system administrator.

About Quality Management

To maintain productivity and a high level of customer satisfaction, the inherent variability of materials and methods used in a process manufacturing environment must be controlled. Most process companies use quality inspection to determine the capabilities of their manufacturing procedures. By understanding process and material variability, process manufacturers optimize throughput without sacrificing product quality.

Understanding Quality Improvement

Quality improvement is a continuous process that controls component variability by monitoring the sources of material instability. Quality responsibilities in the supply chain assist in this process by:

The aim is to identify methods to turn unpredictable manufacturing events into well characterized manufacturing capabilities.

Process control begins with understanding process capability. Knowing how to improve the manufacturing process helps everyone in the supply chain. One of the aims of total quality management is to design quality into products. The overall aim of quality inspection is to ensure material conformance to specification in inventory, production, shipping, and receiving operations.

Designing Quality into Products

Consistent testing of products and materials reduces waste by detecting potential problems before they become major issues. A total quality approach designs the manufacturing process in parallel with the quality testing process. Oracle Process Manufacturing (OPM) Quality Management interfaces quality testing into all aspects of research, development, commercialization, production, purchasing, and shipping operations. This seamless interfacing across the supply chain assists in the consistent development and application of quality standards.

Communicating Quality Throughout the Supply Chain

The most important part of quality management is the successful communication of quality requirements from receipt of incoming materials to the shipment of finished goods. OPM Quality Management provides notification and approval workflows to control quality throughout the supply chain.

Communicating Quality Consistently

Consistency is essential to uniform quality communications. By using common test methods, sampling plans, and decimal precision for reports, the supply chain benefits from a standardized approach to quality testing.

Agreeing to Quality Capabilities

The specification serves as a written agreement on the conformance of a material to a predefined level of acceptance. OPM Quality Management uses the specification and the specification validity rule to manage the inspection sampling. From the laboratory batch to the full production run, the specification validity rule controls the use of the specification in the supply chain. Workflows reduce the specification and validity rule approval process to a series of defined steps that are managed by the application.

Ensuring Proper Sample Collection and Processing

The coordination of sampling throughout the supply chain is often complex and error prone. OPM Quality Management controls the sampling process through workflow notifications to create and process samples. The application monitors business events that require sampling, and optionally updates inventory to reflect material sampled. Using this transaction event-based approach, each of the quality inspection points are coordinated. From material receipt, through batch step release, the sample is traced by source, priority, and disposition.

Ensuring Proper Result Reporting

From result entry to result evaluation, OPM Quality Management coordinates the appropriate capture of electronic signatures for electronic results records. The application composites results and compares specifications on analyzed samples for efficient quality grade assignment and customer specification matching.

Tasks and Responsibilities

Each role in the organization must collaborate throughout the supply chain to ensure effective quality management and information sharing.

The following is representative of the work breakdown structure for managing quality within the supply chain. It lists most of the key tasks and job titles responsible for those tasks:

Process Flow

The following provides a suggested process flow for setting up and running Oracle Process Manufacturing (OPM) Quality Management.

Set Up Other Applications

Set up each of the following applications:

Set Up OPM Quality Management

Set up OPM Quality Management in the Quality Manager responsibility:

Set Up and Create Specifications

Set up and create specifications in the Quality Manager responsibility:

Set Up and Create Item Samples

Set up and create samples in the Quality Manager or Quality Technician responsibilities:

Enter Test Results

Enter results in the Quality Manager or Quality Technician responsibility:

Evaluate Test Results

Results are evaluated in the Quality Manager responsibility:

Composite Test Results

Composite results in the Quality Manager responsibility:

Compare Specifications

Specifications comparison for results is performed in the Quality Manager responsibility:

Set Up, Run, and Evaluate a Stability Study

Refer to the "Stability Testing" topic for a complete discussion of how to set up, run, and evaluate a stability study.

Understanding the Interface to Other Applications

Quality Management interfaces with Oracle Process Manufacturing (OPM) Process Execution, Oracle Inventory, Oracle Quality, and Oracle Purchasing applications to allow the following optional functionality:

Batch Updated by Sample Quantity

When sampling is performed on work in process material, the batch must account for the sample quantity drawn from it. This quantity is either consumed for destructive testing purposes, or it is retained in inventory for possible future testing. The application lets you trace this material by yielding the sample as a byproduct of the batch. In cases where the sample quantity drawn is negligible, the WIP sample quantity can be configured as part of the overall process loss, and does need to be accounted for in the batch.

Batch Step Release Notifies Sampler

Configure the validity rule for a WIP specification to notify appropriate individuals to draw the number of samples required by the sampling plan. The release of a batch step sends a summary notification of all the samples required for the batch. By notifying samplers at the beginning of a batch step, they can prepare for the sample drawing process. This also serves to constrain batch step completion based on the results of quality testing.

Batch Step Completion Controlled by Quality Testing Requirements

The validity rule for a WIP specification prevents a batch step from completing once a sample is taken and quality testing results are pending. Once testing is complete, the application allows the batch step to complete if quality results and the sample disposition are acceptable. Completion of the batch step is not permitted if a sample is rejected, or if adjustments must be made.

Inventory Adjusted for Sample Quantity

The sample quantity can be deducted from the on-hand balance of an item when a sample is drawn from inventory. This inventory adjustment option is configurable at the at the process quality parameter level, which defaults and can be overridden at the specification validity rule and sample levels.

Material Status and Grade Updates Based on a Final Results Set

The application updates material status and grade based on the final results for the item lot sampled from inventory or production. It ensures that each required sample and the sample group has a final disposition that is acceptable or unacceptable before updating the material status and grade of the material sampled.

Receipts Sampled Prior to Being Inventoried

Receiving inspection in Oracle Purchasing is enforced through an inline inspection step using Oracle Quality collection plans before the material is delivered into inventory. A workflow notification is sent for taking lab samples based on an OPM Quality Management supplier specification validity rule. Create a sample against the receipt and receipt line without specifying a lot number. The acceptability of the supplier sample results displays in context with the collection plan results and the accepted and rejected quantities are either delivered into inventory or put on hold for further action.

Inspection Lead Time for Planning

Material that is received or manufactured often requires quality testing before it is used for production or shipping. The duration of quality test can be defined as a post-processing lead time for an item in Oracle Inventory, so that Oracle Advanced Supply Chain Planning recognizes the future availability of the lot without suggesting another planned order. After quality assurance completes inspection and assigns a final disposition, the lot is released according to this hold date or updated to another date in the future.

Changing the Status of Expired Lots

You can access the Inventory Quantities - Mass window to change the status of expired lots.

Refer to the Oracle Inventory User's Guide for a complete discussion of the Inventory Quantities - Mass window.

Understanding Navigation

The following information is a summary of more detailed discussions found in the Oracle E-Business Suite User's Guide.

Navigating the Application

In addition to the standard menu and tool palette, a hierarchical navigator provides a display of the objects in a treelike framework known as a workbench.

Node and Leaf

The top-level nodes in the navigator are expanded to display groups of individual database objects. Lower level nodes, and the objects they contain, are indented to indicate that they belong to these higher level nodes. The terminal node in a branch is called a leaf node.

Menu and Tools

Menu and tools let you access all globally available functions.

Data Organizer

The Data Organizer groups objects on separate tabs. Each has a unique icon and its own hierarchy. The Oracle Process Manufacturing (OPM) Quality Management application uses Data Organizer tabs to group specifications and samples. Refer to the "Identifying Nodes and Tabs on the Navigator" topic for specific nodes and tabs used in OPM Quality Management.

Summary Views

Summary views provide the highest level of business information and only display information. When you select an unexpanded, higher level node on the Data Organizer, the summary view also lists the contents of the container in a multirecord block.

Detail Views

Detail views let you display and edit information.

To navigate the application from the workbench:

The following is a typical flow through the Quality Management application:

  1. Log on to your assigned responsibility.

  2. Choose Quality Workbench from the Navigator menu.

  3. Select the tab that contains the object type of interest.

    • Click Specifications, and select the Show Active Specs indicator to display only approved specifications and specification validity rules. Deselect the indicator to show all specifications and specification validity rules.

    • Click Samples, and select the Show Active Samples indicator to display only pending or in-progress samples. Deselect the indicator to show all samples, regardless of their disposition.

  4. Select the appropriate View By field. This field presents records sorted and grouped by the selection you make.

  5. Use one of the following methods to find the appropriate folder:

    • Expand or collapse entries in the hierarchical Data Organizer.

    • Use the Find feature to retrieve the appropriate object from the results. Save the objects in a Personal or Public folder for future reference in the Data Organizer.

  6. Use one of the following methods to show the detailed view of a selected object:

    • Select the object in the Summary View and click the desired button.

    • Double-click the object in the Data Organizer until you reach the terminal or leaf object.

  7. Perform actions on selected objects that you have permission to edit.

  8. Navigate from detailed view to other related windows.

Identifying Nodes and Tabs on the Navigator

The navigator has these two tabs:

Selecting the Specifications Tab

The following lists some of the typical elements displayed on the navigator when you display active specifications on the Quality Workbench in the View By Specification mode.

The numbers reference each of the nodes and tabs depicted in the graphic that follows this discussion. Click nodes that are marked with a plus (+) sign to expand them.

The following graphic illustrates the previously described nodes and tabs in the navigator window when the Specifications tab is selected:

the picture is described in the document text

Selecting the Samples Tab

The following lists some of the typical elements displayed on the navigator when you display active samples on the Quality Workbench in the View By Organization mode. You can view the samples for organizations that your responsibility can access. The numbers reference each of the nodes and tabs depicted in the graphic that follows this discussion.

Displaying the Samples Summary window:

Display the Samples Summary window for an item by selecting View By Item, and then select the item. Refer to the "Displaying the Samples Summary from the Navigator" topic for a complete discussion of this feature.

Displaying the Item Samples window:

Display the Item Samples window for each sample by expanding the node and selecting an individual sample.

The following graphic illustrates the previously described nodes and tabs in the Quality Management workbench window when the Samples tab display:

the picture is described in the document text

Standard Custom View

A standard custom view lets you query the database for:

Once a view is generated, the criteria or output can be saved for future use in the Personal or Public Shortcuts. Click a node to display a summary window.

Using the Navigator Find Window

Use the Quality Workbench Find Samples or Find Specifications window to find one or a series of specifications and samples.

See: Oracle E-Business Suite User's Guide

To display the Find Samples window from the Quality Workbench:

  1. Navigate to the Find Samples window on the navigator.

  2. Enter one or more search criteria on the Standard, Source, or Advanced tabs.

Standard

  1. Enter the Sample organization and sample number.

  2. Select sample Disposition as:

    • Retain when the sample is reserved and put in storage. Typically, results do not exist for a sample with this disposition.

    • Pending when the sample is saved, and results are expected, but not yet recorded.

    • In Progress when at least one result exists for the sample, but testing is not yet complete.

    • Complete when testing of all required tests and all additional tests is complete.

    • Accept when sample testing is complete, and results are in-specification.

    • Accept With Variance when sample testing is complete, and at least one result is in the experimental error region or out-of-specification. However, the sample approver has accepted this with variance.

    • Reject when sample testing is complete, and results are not acceptable, or out-of-specification.

    • Cancel when the sample is canceled.

  3. Enter Item as the item sampled.

  4. Select the sample Source as:

    • Customer

    • Inventory

    • Supplier

    • Stability Study

  5. Enter Parent Lot as the item parent lot number.

  6. Enter Lot as the item lot number.

  7. Enter LPN as the License Plate Number of the sample. You can select the LPN number from the LOV.

    Note: This field is enabled only for WMS enabled organizations.

  8. Enter Laboratory as the laboratory where the sample is sent for analysis.

  9. Enter Date Drawn as the date the sample was taken. This must be entered in the format DD-MMM-YYYY.

  10. Select Priority as:

    • Normal to indicate that the sample has the usual processing requirements.

    • Low to indicate that the sample has minimal urgency for processing.

    • High to indicate that the sample has urgent processing requirements.

  11. Enter Specification as the specification name and version associated to the sample entered.

Source

  1. Enter any of these additional criteria when Source is selected as Customer, Supplier, Inventory, or WIP:

    • Customer Name

    • Operating Unit

    • Ship To

    • Order

    • Line

    • Subinventory

    • Locator

    • Supplier

    • Supplier Site

    • Purchase Order

    • Line

    • Receipt

    • Line

    • Batch

    • Recipe

    • Formula

    • Line

    • Routing

    • Step

    • Operation

    • Charge

Advanced

  1. In an advanced search of samples, select Item as:

    • Sample

    • Date Drawn

    • Disposition

    • Organization

    • Laboratory

    This selection functions with the Condition field and the Value field to define a custom search. You can enter any number of individual criteria to narrow your search.

  2. Select Condition as:

    • Equals to find targets equal to the specified Value entered.

    • Greater than to find targets greater than the specified Value entered.

    • Less than to find targets less than the specified Value entered.

    • Greater than or equal to to find targets greater than or equal to the specified Value entered.

    • Less than or equal to find targets less than or equal to the specified Value entered.

    • Like to find targets similar to the information specified using the wildcard %.

      For example, if you specify the Item as Sample, select the Condition Like and enter FORM%, then you find each target product that contains entries with the letters FORM.

  3. Enter the Value for the appropriate condition selected.

  4. Click Find. The window displays the results of the search.

  5. Select the drill-down indicator next to the row you want to display the details of the search.

To display the Find Specifications window from the Quality Workbench:

  1. Navigate to the Find Specifications window on the navigator.

  2. Enter one or more search criteria on the Standard, Validity Rule Type, or Advanced tabs.

Standard

  1. Enter Specification as the name for the specification.

  2. Enter Version as the version for the specification.

  3. Select Specification Status for the specification to find as:

    • New to indicate that the specification is new.

    • Request Approval for Laboratory Use to indicate that an approval is requested for using the laboratory specification.

    • Revise for Laboratory Use to indicate that a revision is requested for using the laboratory specification.

    • Approved for Laboratory Use to indicate that the specification is approved for laboratory use.

    • Request Approval for General Use to indicate that a request was made to approve the specification for general use.

    • Revise for General Use to indicate that a request was made to revise the specification for general use.

    • Approved for General Use to indicate that the specification is approved for general use.

    • On Hold to indicate that the specification is on hold.

    • Frozen to indicate the specification is frozen.

    • Obsolete/Archived to indicate that the specification is no longer approved for use and is obsoleted, archived, or both.

  4. Enter Item as the item code for the material being specified as it is listed on the Item Master. The item must be set up as process quality-enabled in the Item Master. Refer to the Oracle Inventory User's Guide for detailed information.

  5. Enter Grade as the grade for the item lot.

  6. Enter Owner Organization as the owner organization of the specification.

  7. Enter Owner as the owner of the specification.

  8. Enter Validity Rule Type as:

    • Customer

    • Inventory

    • Supplier

    • Production

Validity Rule Type

  1. Enter any of these additional criteria when a Validity Rule Type is selected as Customer, Supplier, Inventory, or Production:

    • Organization

    • Status

    • Customer Name

    • Operating Unit

    • Ship To

    • Order

    • Line

    • Parent Lot

    • Lot

    • Subinventory

    • Locator

    • Supplier

    • Supplier Site

    • Purchase Order

    • Line

    • Batch

    • Recipe

    • Formula

    • Line

    • Routing

    • Step

    • Operation

    • Charge

Advanced

  1. In an advanced search of specifications, select Item as:

    • Specification

    • Item

    • Status

    • Owner Organization

    • Owner

  2. Select Condition as:

    • Equals to find targets equal to the specified Value entered.

    • Greater than to find targets greater than the specified Value entered.

    • Less than to find targets less than the specified Value entered.

    • Greater than or equal to to find targets greater than or equal to the specified Value entered.

    • Less than or equal to to find targets less than or equal to the specified Value entered.

    • Like to find targets similar to the information specified using the wildcard %.

      For example, if you specify the Item as Sample, select the Condition Like, and enter FORM%, then you find each target product that contains entries with the letters FORM.

    This selection functions with the Condition field and the Value field to define a custom search. You can enter any number of individual criteria to narrow your search.

  3. Enter the Value for the appropriate condition selected.

  4. Click Find. The window displays the results of the search.

  5. Select the drill-down indicator next to the row you want to display the details of the search.