This topic explains how to set up quality responsibilities, action codes, grades, test classes, test units, sampling plans, and process quality parameters.
This chapter covers the following topics:
If you plan to set up inventory quality attributes, then set up the following in the Oracle Inventory application:
Items and item attributes for every raw material, intermediate, and end item. Items must be set up as process quality-enabled in the Item Master
Unit of measure conversions for each item, between the primary inventory unit of measure and the unit of measure you use, if these are different
Refer to the Oracle Inventory User's Guide for detailed information.
The Maintain Actions window lets you set up action codes in Oracle Inventory, and view all existing action codes. Action codes represent user actions to perform when quality testing yields out-of-specification exception cases, such as out-of-specification conditions, or experimental error results. You can associate an action to a result disposition when you evaluate the result. Action codes are assigned for experimental error at the test and specification levels. They are also assigned in individual specification tests for out-of-specification results. Action codes display for items on appropriate quality reports.
The Find Actions dialog box lets you search for actions by action code, description, or marked for deletion.
Refer to the Oracle Inventory User's Guide for detailed information on setting up and finding action codes.
The Maintain Grades window lets you set up grades and view all existing grades in Oracle Inventory. Grade is a characteristic of an item lot and is usually a combination of inventory and quality attributes. Items must be lot and grade-controlled to enter grades for them. The process of assigning a grade to a lot provides a standardized means of describing its marketability. Grades are often based on criteria such as color, physical size, weight, or appearance. If a lot grade changes on a locator-controlled item, then assign the item to a new locator manually.
The Find Grades dialog box lets you search for grades by grade code, description, or marked for deletion.
Refer to the Oracle Inventory User's Guide for detailed information on setting up and finding grades.
Once you enter action codes, grades, and reasons in Oracle Inventory, use them to set default attributes for inventory items. Quality attributes include grade and material status control.
With material status, Oracle Inventory lets you identify the use of lot-controlled material in production, order processing, or shipping. Once it is determined that a sample does not meet quality specifications or has failed quality tests, change the status of the sample lot for certain purposes in production or shipping.
The first step is to define each Material Status and its associated permissions. After you perform quality tests, change the status of lots that do not meet quality specifications in order to prevent them from being sold or used for production.
Refer to the Oracle Inventory User's Guide for a complete description of setting up material status.
When you select an inventory transaction reason code on the Process Quality Parameters window or the Quality Change Disposition dialog box, only those reason codes that you were granted permission to access display. Refer to the Oracle Inventory User's Guide for detailed information.
Depending on your security profile, some of the information on certain windows may not be available to you. Contact your Product Development Security Manager or Product Development Security Profile Manager if you require access to this information.
Oracle Order Management users define specifications, create samples, and record results for customers, ship-to locations, sales orders, and order lines. Defining a customer order specification requires entry of the operating unit and order information. Customer quality data and Query Find functions display optional fields for customer ship-to location, operating unit, order number, order type, and order line number. To select available inventory based on whether quality results match the customer specification, a sample and a set of results must exist for the order line item and one lot must display in the Oracle Inventory Transact Move Orders window using the Manual Allocate option. Available lots display in addition to information whether an acceptable quality match exists. The Order Management user can view the specification and results for each lot.
In order for specification matching to find results, a sample and set of results must exist for the order line item and one lot must display in the Select Available Inventory window or Transact Move Orders window in Oracle Inventory using the Manual Allocate option.
The Customer Test Results report displays customer number, operating unit, ship-to, order number, type, and line when this information is entered.
The Maintain Actions window lets you set up action codes in Oracle Inventory, and view all existing action codes. Action codes represent user actions to perform when quality testing yields out-of-specification exception cases, such as out-of-specification conditions, or experimental error results. You can associate an action to a result disposition when you evaluate the result. Action codes are assigned for experimental error at the test and specification levels. They are also assigned in individual specification tests for out-of-specification results. Action codes are displayed for items on appropriate quality reports. Refer to the Oracle Inventory User's Guide for detailed information on setting up action codes.
The Find Actions dialog box lets you search for actions by action code, description, or marked for deletion. Refer to the Oracle Inventory User's Guide for detailed information on finding action codes.
The Maintain Grades window lets you set up grades and view all existing grades in Oracle Inventory. Grade is a characteristic of an item lot and is usually a combination of inventory and quality attributes. Items must be lot and grade-controlled in order to enter grades for them. The process of assigning a grade to a lot provides a standardized means of describing its marketability. Grades are often based on criteria such as color, physical size, weight, or appearance. If a lot grade changes on a locator-controlled item, then you need to assign the item to a new locator manually. Refer to the Oracle Inventory User's Guide for detailed information on setting up grades.
The Find Grades dialog box lets you search for grades by grade code, description, or marked for deletion. Refer to the Oracle Inventory User's Guide for detailed information on finding grades.
A test helps determine a quality characteristic or attribute of an item or lot. A test methods describes how a test is performed. A test method can refer to a test protocol or standard operating procedure. Set up tests and test methods using information provided in "Tests."
The Test Classes window lets you group specific tests into meaningful sets for purposes of evaluating them or managing them in workflows, or managing results. You set up basic classes for each test data type.
Here are some examples of test classes:
CHEMICAL, a test class containing test measurements of pH, sugar content, or water content
PROTEIN, a test class containing test measurements of total protein, albumin, and globulin.
MICROBIO, a test class containing test measurements of bacterial, fungal, or viral components
ENTERICS, a test class containing tests for enteropathogens
PHYSICAL, a test class containing test measurements of specific gravity, hardness, or visual opacity
DISSOLVE, a test class containing measurements for various materials to dissolve
Analyze all tests performed and group them into meaningful classes.
Develop a list of test classes and descriptions.
Navigate to the Test Classes window.
Enter a code for the test Class. Required.
Enter a Description for the test class. Required.
Save the window.
Refer to "Setting Up Test Groups" for detailed information on test grouping.
The Find Test Classes dialog box lets you search for test classes by class, description, or marked for deletion.
Enter a test class.
Navigate to the Find Test Classes dialog box.
Enter any of the following to narrow your search:
Class code
Description of the class
Select Marked for Deletion as:
Yes to find test classes that are marked for deletion.
No to find test classes that are not marked for deletion.
Leave this field blank if you do not want to limit your search based on whether a test class is marked for deletion.
Click Find. The Test Classes window displays the results of the search.
Click New. The Test Classes window displays.
Create a new test class as described in "Setting Up Test Classes."
A test group organizes tests into a meaningful set for collaborative analysis. Test grouping facilitates the rapid creation of specifications and addition of tests during sample analysis. After tests are grouped and sequenced into a test class, you can add a test group to a specification or results record using the Test Group window. You can add individual tests or all tests in the group before the specification is approved or results have a final sample disposition. A test can belong to only one test class or test group.
See: Oracle E-Business Suite Flexfields Guide
Perform all required setup procedures.
Enter tests.
Optionally, enter specifications for test group assignment.
Navigate to the Test Classes window.
Enter a Test Class.
Enter a Description for the test class.
Select the Test Group indicator to treat the test class as a test group.
Navigate to the Tests window.
Enter a test as described in "Entering Tests."
Select the desired test class with a previously defined Test Group indicator.
Enter Ordering as the sequence number for the test to appear in the list of tests in the test group. Tests are listed in ascending order. If you plan to add tests before 10, then sequence the list beginning at 10.
The Test Units window lets you set up quality test units and view all existing quality test units. Set up standard or custom test units such as %T for percent optical transmittance, or A for spectral absorbance. Test units are used for recording results.
If you want to convert test units, then set up an expression test for the conversion. For example, to convert a Celsius temperature of 100 degrees into degrees Fahrenheit, multiply the Celsius temperature reading by nine-fifths, or the decimal 1.8, to get 180. Then, add 32 to 180 to get 212 degrees Fahrenheit. The expression is:
"CELSIUS" test result
"FAHRENHEIT" expression is: (1.8*"CELSIUS")+32
See: Oracle E-Business Suite Flexfields Guide
Analyze all tests performed and identify their reporting units.
Develop a list of units and a description for each one.
Navigate to the Test Units window.
Enter a code for the test Unit. Required.
Enter a Description of the test unit. Required.
Save the window.
The Find Test Units dialog box lets you search for test units by unit, description, or marked for deletion.
Navigate to the Find Test Units dialog box.
Enter any of the following to narrow your search:
Unit code
Description of the unit
Select Marked for Deletion as:
Yes to find test units that are marked for deletion.
No to find test units that are not marked for deletion.
Leave this field blank if you do not want to limit your search based on whether a test unit is marked for deletion.
Click Find. The Test Units window displays the results of the search.
Create a new test unit as described in "Setting Up Test Units."
The Sampling Plan window lets you define how much and how often to sample. By entering the number, size, and frequency of samples to take, the sampling plan lets you prescribe sample groups. Used in conjunction with the Sample Creation Notification workflow, individuals responsible for sampling are notified when and where to sample materials that require quality testing. Sampling plans are an optional setup. They are associated to a specification validity rule on the Validity Rules for Item Spec window.
The Count, Frequency Type, and Frequency Period, or Per fields, work together to define the number of repetitions for sampling.
For example, to indicate ten samples that each contain 5 milliliters every hour, you would enter:
Count = 10
Quantity = 5 mL
Per = 1 hour
The following are examples of each sampling plan type:
Quantity-based Sampling Rate
Quantity-based sampling is entered in a valid inventory UOM. To take one sample every 1,000 kilograms produced, enter:
Count = 1
Per = 1000 kg
Fixed Number of Samples to Take
Fixed number sampling is entered for a batch, batch step, or receipt. To take three samples per receipt, enter:
Count = 3
Per = 1 Receipt
To take two samples of 10.0 grams for every five batches produced, the sampling plan is entered as:
Count = 2
Quantity = 10.000000000
UOM = GRAM
Frequency Type = Fixed Number
Per = 5 Batch
Percentage of Samples to Take
Percentage-based sampling frequency applies to the amount of product produced, or the amount of item delivered. To sample 20% of a delivery, enter:
Count = 1
Per = 20 Percent Amount of Product Produced
Defining a sampling plan is optional. Setup a sampling plan before you create specifications and samples in which you intend to use it. A sampling plan becomes effective for a process quality-enabled item and optionally, for a grade when it is associated with a specification validity rule. The Validity Rules for Item Spec window displays all applicable details of a sampling plan if one is selected for use. You can have required, reserved, or archived samples associated with a sampling plan. As long as one of these sample types is specified, the sampling plan is valid.
You can use flexfields and attachments with this window.
See: Oracle E-Business Suite User's Guide and Oracle E-Business Suite Flexfields Guide
Navigate to the Sampling Plan window.
Enter the Name for the sampling plan. Required.
Enter a Description for the sampling plan. Required.
Required Samples
Enter the Count as the number of samples to take at each instance of the frequency entered. You do not have to enter this field. You can specify the sampling plan in terms of reserved or archived samples to be taken.
Enter Quantity and UOM as the sample size, or the amount of material needed to take a sample from the material requiring inspection. This is expressed in the primary inventory unit of measure as defined in Oracle Inventory. Required.
Enter the Frequency Type as previously described:
Quantity Based to indicate quantity-based sampling in a valid inventory UOM. Enter the sample UOM.
Fixed Number to indicate fixed number sampling for a batch, batch step, or receipt.
Percent to indicate sampling by percentage of product produced, or percentage of item delivered.
Enter Per as the frequency period. Count, Frequency Type, and Frequency Period or Per fields work together to define the number of repetitions for sampling.
Depending on the entry you make in the Frequency Type field, do one of the following:
For quantity based sampling, enter a valid inventory UOM.
For fixed number sampling, select Batch, Batch Step, or Receipt.
For percent sampling, select Amount of item delivered or Amount of product produced.
Reserved Samples
Enter Count as the number of samples to take at each instance of the frequency entered.
Enter the Quantity of sample for the reserved sample.
UOM displays the unit of measure for the sample size. This defaults from the default UOM for required samples.
Archived Samples
Enter Count as the number of samples to take at each instance of the frequency entered.
Enter the Quantity of sample for the archived sample.
UOM displays the unit of measure for the sample size. This defaults from the default UOM for required samples.
Save the window.
The Find Sampling Plans dialog box lets you search for sampling plans by name, frequency type, or marked for deletion.
Enter a sampling plan.
Navigate to the Find Sampling Plans dialog box.
Enter any of the following to narrow your search:
Name of the sampling plan
Frequency Type of the sampling plan as Quantity Based, Fixed, or Percent
Select Marked for Deletion as:
Yes to find sampling plans that are marked for deletion.
No to find sampling plans that are not marked for deletion.
Leave this field blank if you do not want to limit your search based on whether a sampling plan is marked for deletion.
Click Find. The Sampling Plan window displays the results of the search.
Click New. The Sampling Plan window displays.
Create a new sampling plan as described in "Setting Up Sampling Plans."
The Process Quality Parameters window lets you set up system defaults to enforce quality management business rules for a specific organization. This window serves as a default template that is typically defined at the time of implementation by a system administrator and may be updated later. Following are windows and options that are configurable on other Oracle Process Manufacturing (OPM) Quality Management windows:
Validity Rules for Item Spec window
Control Batch Step Status
Control Lot Attributes
In-Specification Status
Out-of-Specification Status
Update Inventory Quantity
Lot Optional
Delayed Lot Entry
Item Samples window
Lot Retest
Update Inventory Quantity
Mass Search and Replace window
When you select an inventory transaction reason code on this window, only display those reason codes that you were granted permission to access. Refer to the Oracle Inventory User's Guide for detailed information on reason code.
Set up organizations as process-enabled.
Set up quality action codes in Oracle Inventory to assign them to retest and resample actions.
Set up reason codes in Oracle Inventory for the inventory transaction for samples.
Set up material statuses in Oracle Inventory for in-specification and out-of-specification statuses.
Navigate to the Process Quality Parameters window.
Enter the desired default process-enabled inventory Organization.
Organization Type
Select Organization Type as Quality Laboratory to designate the organization as a quality laboratory where the sample is analyzed.
Plant is selected if an organization is defined as a plant organization in OPM Product Development. This field is display only.
Laboratory is selected if an organization is defined as a research and development laboratory organization in OPM Product Development. This field is display only.
Note: Quality Laboratory is used to designate the organization as a quality laboratory where the sample is analyzed. Laboratory is selected if an organization is defined as a research or lab organization in OPM Product Development.
Spec
Yes to activate full version control for specifications. Changes made to an unapproved specification require a new version.
No to specify that specification version control is not active for specifications. You can make changes to an existing unapproved specification without changing it version.
Optional to specify that version control is discretionary for specifications. Create a new version when you update an existing unapproved version.
Select Exact Spec Match if a specification must be an exact match based on the sample source or inventory selection criteria. Deselect to enable the application to retrieve the specification that best matches this criteria based on the specification matching hierarchy. For detailed information refer to "Specification Matching Business Rules" in Appendix B.
Actions
Enter a Retest Action for samples. Retest actions are set up in Oracle Inventory.
Enter a Resample Action for samples. Resample actions are set up in Oracle Inventory.
Spec Validity Rule
Select Create Samples Automatically to enable automatic sample creation on the Specification Validity Rules window for an Inventory, WIP, or Supplier sample type.
Select Lot Optional to bypass the entry of a lot number while creating a sample against a lot-controlled item. Deselect to require a lot to be entered on a sample.
Select Delayed Lot Entry to require the entry of a lot number when assigning the final disposition for a supplier, inventory, or WIP sample. Deselect to make the entry of a lot optional when assigning the final sample disposition. Delayed Lot Entry is available only if Lot Optional is selected. Refer to "Delaying the Entry of Lot Numbers" for additional information.
Select Control Batch Step Status to indicate that you want quality test results to control the completion of batch steps. The batch step quality status of whether sampling and results are required is reflected at the batch step level. Only in-specification results permit a batch step to complete.
Inventory Updates
Enter an inventory Transaction Reason code. This previously defined reason code is used for the sample inventory transaction, when a sample record is created and Update Inventory Quantity is selected.
Select Update Inventory Quantity to enforce an inventory transaction for drawing the sample quantity.
Select Control Lot Attributes for the application to update lot attributes status, grade, and hold date based on the test result of samples in a sample group.
Enter the default In-Spec Status to update the material status when in-specification results are entered. The sample group has a disposition of Accept and Control Lot Attributes is selected.
Enter the default Out-of-Spec Status to update the material status when out-of-specification results are entered. The sample group has a disposition of Reject and Control Lot Attributes is selected.
Samples
Select Manual Spec Selection to override the default specification and select an alternate specification on the Item Samples window. Select from a list of applicable specifications chosen from the specification matching hierarchy. This list is ordered based on the most specific to the most generic match. For detailed information, refer to "Specification Matching Business Rules" in Appendix B. Deselect to use the default specification only.
Select Consider Optional Tests Results for optional tests that display on the specification and results records to contribute to the final disposition of the sample. Deselect to exclude optional test results when assigning a final sample disposition. For example, a new test which is measured over time does not factor into sample dispositions until its test limits are formalized based on the results collected. The Consider Optional Tests Results option is specific to a specification validity rule organization and is enforced for all item specifications in which the test is used. If an optional test result is used, then its result evaluation is factored into the possible sample dispositions. An out-of-specification result for an optional test only permits the sample disposition to change to Accept with Variance, Reject, or Cancel.
Select the Account to use for deducting inventory for samples creation. The Account list is based on the organization you select.
Document Numbering
Select Assignment Type as:
Automatic for the system to automatically generate the sample number when creating a sample
Manual to manually enter the sample number
If the Assignment Type you select is Manual, then enter Last Assigned as the starting number for the automatic generation of samples. This field is disabled if Assignment Type is Manual.
Results
Applications Programming Interface Decimal Precision
Select one of the following for Applications Programming Interface Decimal Precision:
Round to round decimals for the data imported by the Applications Programming Interface
Truncate to truncate decimals for the data imported by the Applications Programming Interface. If a test or specification is defined with a decimal precision that is less than the default of nine places and the numeric results are imported using an Applications Program Interface (API), then the numeric results are rounded as indicated by this entry.
Stability Studies
Document Numbering
Select Assignment Type as:
Automatic to automatically generate the sample number when creating a sample
Manual to manually enter the sample number
Enter Last Assigned as the starting number for the automatic generation of samples, if the Assignment Type is Manual. This field is disabled if Assignment Type is Automatic.
Mass Search and Replace
Select from the following values in the Default Spec Status field:
New (Default)
Approved for Laboratory Use
Approved for General Use
Select an option from the following values in the Managing Validity Rules field:
Copy and Set Obsolete Status for Old Rules to copy validity rules from the old specification to create validity rules against the new specification. The statuses of the validity rules for the old specifications change to Obsolete.
Copy and Set End Date for Old Rules to copy validity rules from the old specification to create validity rules against the new specification. The Effective To Dates of validity rules for the old specifications are set to the system date and time.
Copy to copy validity rules from the old specification to create validity rules against the new specification. The validity rules are created with a status of New. Validity rules from the old specification are not affected.
Do Not Create (Default) to not create any validity rules for the new specification. Validity rules from the old specification are not affected.
Save.