This topic includes procedures for entering and finding item samples and monitoring samples. Procedures for displaying sample groups and displaying sample summaries on the navigator are also provided.
This chapter covers the following topics:
Acceptance sampling supports quality inspection of materials during various points in the supply chain. This includes sample collection at events such as receiving, batch creation, batch step release, production yield, and lot expiration. Sampling inspection also occurs for material received from suppliers, for work in process material, for inventory, for specific customers, and for shipments. Samples are also created as part of a stability study for a particular item.
You can take multiple samples from the same source, and their collective disposition can be used to control and update other processes in the supply chain. Samples can be taken to monitor environmental conditions of locators or resources used for material storage.
Refer to "Setting Up Sampling Plans" for a discussion of the sampling plan.
Samples are sent to a quality laboratory organization for testing. The organization must be process-enabled and defined a Quality Laboratory in the Process Quality Parameters window. For detailed information on inventory organizations, refer to the Oracle Inventory User's Guide.
If an item substitution affects the quality specifications required for a batch, then you can change the specification association for a sample during sample creation or specification comparison. Refer to the Oracle Process Manufacturing Product Development User's Guide for detailed information on item substitution.
You can set up a manual or automatic document numbering scheme for samples in the Process Quality Parameters window. If you create a sample with Assignment Type as Automatic, then the sample number is generated automatically. Automatic sample numbers are noneditable, sequential numbers. If you create a sample with Assignment Type as Manual, then you can enter the sample number.
Sampling methodologies are definable and maintainable using a sampling plan. The sampling plan lets you define the number of required, reserved, and archived samples. It also lets you specify the sample quantity and sampling frequency. Set up the optional sampling plan prior to creating specifications and samples. It becomes effective for an item, and optionally for a grade, when it is associated with a Specification Validity Rule. When a specification is associated to a sample, some data from the sampling plan defaults into the sample record:
Sample quantity
Number of samples required
Refer to "Setting Up Sampling Plans" for more information.
The sampling process can be performed whether the Sample Creation Notification workflow is enabled or disabled. Following are the conditions:
You receive a notification to take samples when the Specification Validity Rule in effect requires sampling for an event. If a sampling plan is defined, then the notification window displays details of the applicable sampling plan.
If a batch creation triggered a sample notification, then the batch number defaults as the sample source information. Optionally, if the batch step is not entered by default, then enter the batch step where the sample was taken and save the sample.
Once testing is complete, results are entered against the sample. Enter or update additional sample details such as sample expiration date and time and the storage subinventory and storage locator on the sample record. Run the Inventory Date Notification concurrent program in Oracle Inventory to either send a notification to manually or automatically create samples based on lot retest or lot expiry. The concurrent request can launch the Lot and Serial Date Notification workflow, which raises the business events for reaching the lot retest or expiry date. The Inventory Date Notification concurrent request searches for item lots that are process quality-enabled in a process-enabled inventory organization. Refer to the Oracle Inventory User's Guide for detailed information on the concurrent request parameters.
When a batch is terminated, the Sample Creation Workflow notifications that are open are canceled. Manage any samples that are created against the batch.
Automatic sample creation simplifies data entry and integrity when sampling in high volume production environments, or at various points in the supply chain. When you set up automatic sample creation, the application creates planned sample records with the default sample group information such as batch, item, and optional lot. This is based on a business event in the application. Existing business events that can trigger the sample creation workflow include lot expiration and retest, inventory adjustment, batch or batch step creation, batch step release, and receiving material into inventory or a receiving location. Automatic sample numbering and the sampling plan information such as sample count, sample quantity, and UOM, provide the information to create several sample records simultaneously, and associate these samples to a sample group. The application can create required, archive, and reserve sample record types. When samples are taken physically, you can update the planned sample records with details that include the actual sample quantity taken, date drawn, and sample expiration date.
Responsibilities: Workflow Administrator Event Manager, AME Application Administrator, Quality Manager
Setting up for automatic sample creation:
Set the process quality parameter for sample Assignment Type to Automatic for automatic document numbering of samples in the creation organization. Required.
Enable the business event that triggers automatic sample creation. Required.
Set up the quality workflow for notification of planned samples created by the system. Optional.
Define a sampling plan. Required.
To use automatic sample creation:
Create an item specification with a specification validity rule that has Create Samples Automatically enabled and a sampling plan associated.
Trigger the business event, for example, create inventory, create a batch, release a batch step, receive into a receiving locator or inventory.
Open the workflow notification or query the sample group though the Quality Workbench, Samples Summary, or Sample Groups window to view the planned samples created by the application.
Take physical samples by changing the sample disposition from Planned to Pending or Retain. Enter the actual sample quantity and date drawn.
Determine the material to sample. This includes items that require retesting and items that require evaluation of their expiration date. Refer to "Reports and Inquiries" for reports to run that assist in this process. When the Sample Creation Notification workflow is not enabled, create a sample directly using the Item Samples window.
Delayed lot entry lets you create a sample without entering a lot number. It postpones the identification of a lot number during sample creation until it is known at the time of assigning a final disposition. This delay accommodates sampling processes in which the material is analyzed before delivery to inventory. When assigning a final sample group disposition, the lot is specified, so that quality-driven updates to the lot status, grade, hold date, reason code, and the recommended lot-specific unit of measure conversions can occur simultaneously. For WIP and Supplier samples, the lot must belong to the batch or receipt specified at the time of sampling. After the lot number is entered at disposition time, it displays in all the sample records within the sample group for genealogy purposes.
Setting Up for Delayed Lot Entry
The Delayed Lot Entry indicator is available when Lot Optional on Sample is selected in the Process Quality Parameters window or the Validity Rules for Item Spec window. Select Delayed Lot Entry to permit the entry of a lot number only when the sample is assigned a final disposition of Accept, Accept with Variance, or Reject. Deselect to permit the entry of a lot number only at sample creation for supplier, inventory, or WIP sources.
Prerequisite
Select Lot Optional on Samples and Delayed Lot Entry in the Process Quality Parameters window and in he applicable specification validity rule.
To delay the entry of a lot numbers on a sample:
Create a sample without entering a lot number. The Lot field is protected after you save the sample.
Enter and evaluate results.
Assign a final sample group disposition and enter the following:
Lot number, to update all sample records in the sample group.
Lot update information, including requirements for status, grade, hold date, and the UOM conversion recommendation.
Lot number and appropriate lot update information displays for all the samples in the sample group. If the sample group has a single sample, then update the sample to a final disposition to enter the lot number. Otherwise, composite results before you assign a final sample group disposition and enter the lot number.
This feature reflects the sample quantity taken from a batch by modeling the sample as a batch byproduct. An inventory transaction for this sample byproduct is created automatically based on the reason code defined on the Process Quality Parameters window.
Formulator, Process Engineer, Production Supervisor, Quality Manager
Configure the Process Quality Parameter for Inventory Transaction Reason.
Set up an item for the material to sample from the batch.
To update the batch with the sample quantity:
Create a formula by entering the item to sample as a byproduct formula line:
Set the byproduct quantity equal to the quantity you plan to take as a sample.
Set the Yield Type to Manual, and the Byproduct Type to Sample.
Change the status of the formula to Approved for General Use.
Create a recipe that contains the formula.
Create a recipe validity rule for the recipe and the organization in which you will run the batch.
Change the status of the recipe and the status of the recipe validity rule to Approved for General Use.
Create and approve a specification for the item.
Create and approve a WIP specification validity rule, specifying the recipe, formula, and formula line at which the sample byproduct is yielded. Ensure that the Update Inventory Quantity indicator is selected
Create a batch from the recipe. If the Sample Creation Notification workflow is enabled, then the system prompts for the creation of the WIP sample when the batch is created.
Release the batch.
Create a sample for the item in the batch. An inventory transaction is created for the byproduct line in the batch. If the Sample Creation Notification workflow is not enabled, then use the Get Spec function to tie the sample record to the applicable WIP Specification Validity Rule for the sample byproduct line in the batch.
When a batch is terminated, the sample creation workflow notifications that are open are canceled. Manage any samples that are created against the batch.
Record the sample expiration date and time to indicate sample shelf life. The sample expiration date and time defaults to the corresponding lot expiration date. This date is stored for informational purposes, and used as a reminder to complete required testing, and properly dispose of the sample.,
Samples that originate from the same source or business event can be grouped together as a sample group so that the composite of their results can be reported or used to control inventory, production, receiving, shipping, and allocation processes.
If samples are not created using the workflow, then they can still be grouped by the Get Spec function that associates the same specification and version to these samples. Refer to "Appendix B" for the hierarchies used. The specification validity rule for this specification and version identifies the sampling plan where the required sample count is number of samples required in the sample group. When a new sample and sample group are created and a sampling plan is not specified in the specification validity rule, then the number of samples required in the sample group (and reflected in the sample record) is one.
By default, when you click Get Spec or save the sample record the application groups samples associated to the same specification and version until the sample group has a final disposition. For example, if the sampling plan requires three samples, then the first sample record has a sample instance of one of the three samples required. Each time a sample is added to a sample group, the total samples required increases by one, and each new instance is numbered appropriately in the series. When you use the Get Spec function, you can also create a new sample group instead of adding the new sample to an existing sample group.
The Get Spec function retrieves item specifications for item samples and monitoring specifications for monitoring samples. You can continue to add samples to a sample group while the sample group disposition is Pending, In Progress, or Complete. Samples with a disposition of Complete revert to In Progress when you add a test.
Lots can be created with a reference to a parent lot. A sample or sample group can represent the quality characteristics of a single lot or multiple lots, indicated by specifying a parent lot only. For samples against a particular lot, the final sample group disposition can update lot attributes such as material status and grade for the lot specified. For samples against a parent lot only, the lot attributes update can apply to all lots one level below the parent lot.
An item sample group contains one or more samples that share the same organization, item, and source, and optionally, the same lot. Tie the sample group to a specification and specification validity rule at the Item Samples window for the first sample created. This must be done before assigning a sample group disposition or creating composite results.
Quality characteristics for a lot are determined through inspection samples or by associating a sample with another sample group. You can do this by using the parent lot disposition, results association between item samples, or lot transactions such as split, merge, or translate. For example, a lot split transaction can inherit the quality sample taken against the source lot through to the destination lot. Refer to "Associating Results to Another Sample" topic and to the Oracle Inventory User's Guide for detailed information on lot transactions. The Lot Genealogy inquiry or the specification matching functionality using the Select Available Inventory window initially searches for samples taken against the specified lot before using the inherited sample group association to retrieve the samples.
Assign a control sample disposition manually, by responsibility, when the Sample Creation Notification workflow is not enabled. To assign a new disposition, choose Change Disposition from the Actions menu on the Samples window. The following summarizes sample disposition change possibilities:
Change from Planned to:
Pending
Retain
Cancel
Change from Pending to:
Cancel
Retain prior to the sample being saved.
Change from Retain to:
Pending in anticipation of sample analysis..
Cancel to terminate analysis
Change from In Progress to:
Accept with Variance if results are recorded, and at least one result is in an experimental error region, or out-of-specification. However, the sample approver must accept this variance.
Reject if results are recorded and at least one is not acceptable.
Cancel to terminate additional analysis.
Change from Complete to:
Accept if results are recorded and acceptable, and sample results are within the limits of the specification.
Accept with Variance if results are recorded, and at least one result is in an experimental error region, or out-of-specification. However, the sample approver must accept this variance.
Reject if results are recorded and at least one is not acceptable.
Cancel to terminate additional analysis.
Change from Accept to:
Accept with Variance if results are recorded, and at least one result is in an experimental error region, or out-of-specification. However, the sample approver must accept this variance.
Reject if results are recorded and at least one is not acceptable.
Cancel to terminate additional analysis.
Change from Accept with Variance to:
Reject if results are recorded and at least one is not acceptable.
Cancel to terminate additional analysis.
Change from Reject to:
Cancel to terminate additional analysis.
The Sample Storage Summary inquiry lets you find item samples based on their storage subinventory and storage locator. The Item Inquiry window in the Oracle Inventory application is used to find the sample storage locator based on the item and lot number.
Following is a discussion that describes the differences among retained, archive, and reserve samples:
A Sample Disposition of Retain identifies that a sample is stored for possible future testing. Retained samples can be used as a control group for subsequent samples that have been tested against the same sample source. Samples drawn from the same source can be separated into aliquots, or fractional samples. These samples can be used for standard quality testing, archived into storage for investigative or forensic testing, or reserved as a backup for possible future testing. A retained sample is classified by its use or type.
Retained samples can be submitted for analysis later according to the specification assigned to the sample group. You can change the sample disposition of a standard testing sample from Retain to Pending to indicate that analysis is expected, and initiate the optional OPM Quality Test notification workflow if it is enabled. For example, a stability sample is created and put into storage. Later, it is pulled for time point testing according to an item specification. Samples with a disposition of Retain are not available for entry of results until the sample disposition is changed to Pending. You cannot change the disposition of a tested sample to a disposition of Retain.
The samples for archive and reserve use do not contribute to the total number of samples required in a sample group based on a sampling plan. Therefore, it is important to distinguish these samples for traceability purposes. A standard testing sample is created based on the sampling plan definition.
The archive sample can be used to research a market complaint. This sample is stored immediately in sample archives without any default specification assignment or initial testing. When analyzed, select the specification or add tests manually to an archive sample. The archive sample can progress through the existing sample dispositions (Pending, In Progress, Complete, Accept, Accept with Variance, Reject, or Cancel), but it remains in an archived state without any of the subsequent updates to inventory and production based on the specification validity rule.
Requirements for setting up archive samples:
Specify the document numbering assignment type for samples in the creation organization where the samples are taken. Required.
Define a sampling plan. Optional.
Create and approve item specifications and specification validity rules. Optional.
To use archive samples:
Create an item sample retained as an archive sample. Associate it to a specification with a sampling plan. Optional.
Query the archive sample, change the sample disposition to Pending, and optionally, schedule tests from the associated specification upon request for investigation.
Perform tests, enter results, and change sample disposition when the analysis is complete.
This type of retained sample is set aside as additional inventory from the same sample source. A reserve sample is used as a backup supply of additional testing material when one or more tests are repeated due to instrumentation problems or reagent failure. Its quantity is consumed when the original sample for standard quality testing is insufficient to complete all required testing. A reserve sample remains in the Retain sample disposition and can only be changed to a disposition of Cancel. This supports the recording of results that are performed against a reserve sample, but reported against the original sample for standard quality testing.
Requirements for setting up reserve samples:
Set up document numbering assignment type for samples in the creation organization where samples are taken. Required.
Define a sampling plan. Optional.
Create and approve item specifications and specification validity rules. Optional.
To use reserve samples:
Create item samples in the same sample group as a required sample, and retain an additional sample as the reserve sample. Optionally, associate these samples to a specification with a sampling plan.
Enter results against the required sample. When the remaining sample quantity of the required sample is insufficient for continuing analysis, select the reserve sample for the test where an additional testing quantity is needed, and enter results.
Change the sample disposition of the required sample when analysis is complete.
Stability study sample records are created by the application when the planned stability study is approved. These samples are based on the:
Number of samples per time point
Number of retained samples for a variant
Sample quantity and UOM defined for a variant
These system-generated item samples are automatically associated to a stability study as identified by the sample source fields. You cannot create stability samples manually through the Samples window.
You create a monitoring sample on the Monitoring Samples window. Monitoring samples are taken to check the acceptability of environmental conditions for each variant storage condition in a stability study. You take these samples for tests defined in a monitoring type specification. Refer to "Understanding Specifications" for additional information.
To display the Delayed Lot Entry indicator on the Validity Rules for Item Specifications window, you must select it on the Process Quality Parameters window. If a WIP, Inventory, or Supplier sample is created with the Delayed Lot Entry indicator enabled, then you can create a sample without entering a lot number. Enter the lot number when you enter a final disposition for the sample or sample group.
Setting Up on the Process Quality Parameters Window
The Delayed Lot Entry indicator is available when Lot Optional is selected. The field defaults to null. Select Delayed Lot Entry to permit the assignment of a lot number after sample creation for a supplier, inventory, or WIP specification validity rule. The sample must have a final disposition of Accept, Accept with Variance, or Reject. Deselect to permit the assignment of a lot number only at sample creation for a supplier, inventory, or WIP specification validity rule.
Implementation Considerations
Following is a summary of implementation considerations:
If you enter a lot when you create the sample record, then delayed lot entry is not permitted. The Lot Optional indicator must be selected on a valid item specification validity rule. Do not select Update Inventory Quantity.
Enter a lot number for all the samples in a sample group, because all samples in the sample group are affected. If the lot number changes across samples, then create separate sample groups that correspond to each lot.
The Lot field is not available on the Item Samples window after you save the sample. Enter the lot number when you change the sample group to a final disposition of Accept, Accept with Variance, or Reject. Changing to a final sample group disposition controls several updates to inventory lot attributes. Receiving or in-process inspection results also reflect the quality characteristics of the material inventoried. Therefore, you can enter the lot number simultaneously with updates to its lot attributes such as lot status, grade, hold date, and reason code and the recommended lot-specific unit of measure conversions.
The lot entered must belong to the receipt or batch identified on the supplier or WIP sample record.
The specification matching logic associated to the Get Spec button is based on the sample source information entered when you create a new sample. If a lot is not entered on a new sample record, then it is not included as specification matching criteria.
Process Flow for Delayed Lot Entry
Create a sample without entering a lot number. The Lot field is protected after you save the sample.
Enter and evaluate results.
Assign a final sample group disposition and enter the following:
Lot number, to update all sample records in the sample group Lot update information, including requirements for status, grade, hold date, and the UOM conversion recommendation
Lot number and appropriate lot update information displays for all the samples in the sample group. If the sample group has a single sample, then update the sample to a final disposition to enter the lot number.
Quality Change Disposition Window
Lot is required if:
You access this window from the Composite Results window for a sample group or from the Item Samples window if the sample is the only sample in the sample group.
The Source field is Supplier, Inventory, or WIP for the sample or sample group.
The item is process quality-enabled and lot-controlled.
There is no lot specified on the sample or sample group, and Lot Optional on Sample is selected.
Delayed Lot Entry is selected for the supplier, inventory or WIP specification validity rule associated to the sample.
The current disposition is changed to a final disposition of Accept, Accept with Variance, or Reject. An error message displays if the lot is entered and the sample disposition is not updated.
A sample or sample group can represent the quality characteristics of a single lot or multiple lots, indicated by specifying a parent lot only. For samples against a particular lot, the final sample group disposition can update lot attributes such as material status and grade for the lot specified. For samples against a parent lot only, the lot attributes update can apply to all lots one level below the parent lot.
The Item Samples window lets you create samples from the following sources:
Inventory
WIP
Supplier
Customer
Refer to the "Understanding Sampling" topic for an explanation of sampling.
Note: You cannot create stability study samples from this window. However, you can query a sample with the Stability Study source from this window. Refer to the "Stability Studies" topic for additional information. You cannot create monitoring sample from this window. Refer to the "Entering Monitoring Samples" topic for additional information.
A sample group is created by a transaction event such as a receiving transaction, or an inventory transaction. If the Item Samples window is accessed from the Sample Creation Notification workflow, then the Item Samples window displays the following information:
Organization
Specification Name, Version, and Grade
Source data, depending on where the sample is created
Item and Item Revision
Date Drawn
Default for Update Inventory Quantity box, based on the Specification Validity Rule
Priority as Normal
Disposition as Planned or Pending
If a sampling plan is associated to the specification validity rule in effect, then Retain As, Sample Quantity, Sample Quantity UOM , and Samples Required fields also default in the Item Samples window. Enter the following information:
Sample Number, unless automatic sample numbering is enabled
Sample Description
Parent Lot
Lot, unless defaults are available from the sample group
Lot Retest
Quality Laboratory
External ID
Storage Organization
Storage Subinventory
Storage Locator
When you create a sample without using a workflow notification, the Item Samples window displays the following information:
Disposition is Pending
Source defaults to Inventory
Update Inventory Quantity box is cleared
Sample Priority defaults to Normal
Enter the following minimum required information:
Sample, unless automatic sample numbering is enabled
Sample Description defaults from the item entered
Retain As an Archive, Reserve, or required sample
Source data, based on where the sample is created
Lot for lot-controlled items unless marked Optional on the Process Quality Parameters window
Quantity
UOM
Date Drawn, which defaults to the current date and time
There may be an e-signature event associated with this window. Refer to "Appendix D" for additional information on e-record and e-signature approvals associated with this window.
You can use folders, attachments, and flexfields with this window.
See: Oracle E-Business Suite User's Guide and Oracle E-Business Suite Flexfields Guide.
Set up a quality lab organization where sample testing is performed.
Set up Process Quality Parameters for required indicators and configurations including Exact Spec Match, Update Inventory Quantity, Lot Optional, Manual Spec Selection, Create Samples Automatically, Delayed Lot Entry, Control Batch Step Status, Inventory Transaction Reason, Update Inventory Quantity, Control Lot Attributes, In-Spec Status, Out-of-Spec Status, and Consider Optional Test Results in the Process Quality Parameters window.
Set up document numbering for automatic or manual sample numbering in the organization where you take samples in the Process Quality Parameters window.
Enter tests, and optionally create an approved specification and specification validity rule for sampling.
Optionally, enter a sampling plan.
Optionally, set up and activate the Sample Creation Notification workflow.
Set up parent lots, lots, and lot attributes.
Navigate to the Item Samples window. The process-enabled organization displays in the window title. Select a different organization using the Organizations window.
Enter the Sample. If automatic sample numbering is selected, then the Sample field is blank and disabled until the record is saved, at which point a sample number is assigned. Otherwise, enter the number. Required.
Enter the Disposition as the sample status:
Planned when the sample is scheduled to be taken.
Retain when the sample is taken and put in storage. Results cannot exist for a sample with this disposition.
Pending when the sample is saved, and results are expected, but not yet recorded. This is the default disposition.
Cancel when the sample is canceled.
Required.
Refer to "Understanding Sampling" for an explanation of how to change sample disposition.
Enter a Description for the sample. If you do not enter a description, then the item description defaults from the item entered.
If Retain is the disposition, then enter Retain As to indicate whether the sample type is an Archive, Reserve, or required sample.
Enter Item as the process quality-enabled item sampled. A description of the item displays. Required.
Enter the item Revision. If the item is not revision-controlled, then this field is disabled. Required.
Enter a Priority for the sample 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.
Select the sample Source as Inventory.
Select the restricted or non-restricted Subinventory where the item sampled is located.
Select the restricted or nonrestricted Locator if the subinventory and item are locator-controlled. Locator control is defined at the organization, subinventory, or item level. .
Note: Restricted subinventories indicate whether to restrict transactions of an item to or from a subinventory specified in a list you define using the Item/Subinventory Information window in Oracle Inventory. Restricted locators indicate whether to restrict a transaction of the item to or from a locator specified in the list you define using the Item/Subinventory Information window in Oracle Inventory. You cannot restrict locators unless you also restrict subinventories.
Enter the sample item Parent Lot, if the item is child lot-controlled. Refer to "Understanding Parent Lots and Lots" for detailed information on parent lots and lots.
Enter the sample item Lot code. Edit this field if the item entered is child lot-controlled. Lot is not required if marked as optional for samples on the Process Quality Parameters window.
Enter the LPN for the inventory sample to consume. You can select the LPN number from the LOV. This field is enabled only for WMS enabled organizations.
Lot Retest is selected if the sample is taken for lot retesting. If the Lot Expiry/Retest Notification workflow is running, then this field defaults.
Name is the item specification name.
Version is the item specification version.
Grade is the grade associated to the specification version.
Note: If the sample was previously associated to a specification using the Sample Creation Notification workflow, then the Get Spec function is disabled. If a sample source field (Lot, Subinventory, or Locator) is changed, then the Spec, Version, and Grade fields are cleared. You can also save a sample without having a specification associated to it.
Click Get Spec to associate a specification for this sample. The Specification Association dialog box displays.
Select one of the following:
Use Default displays the specification, version, and grade with a specification validity rule that exactly or best matches the sample source information entered. The specification match depends on the process quality parameter Exact Spec Match in the Process Quality Parameters window. Select Exact Spec Match if a specification needs to be an exact match. Deselect if a specification does not need an exact match. The best match is based on the specification matching hierarchy described in "Specification Matching Business Rules" found in "Appendix B".
Use Alternate to select a specification that is different from the default specification for the sample. If Manual Spec Selection is enabled in the Process Quality Parameters window, then select Use Alternate. Select from a list of applicable specifications chosen from the specification matching hierarchy. This list is ordered based on the most specific to most generic match. If you select Use Alternate, then select the Spec as the alternate specification to use. The current Version and Grade display.
Note: If there is an existing sample group that matches the sample source and specification selected, then the Created On, Samples Taken, and Samples Required fields display. Deselect Create New to add the new sample to the existing sample group. Select Create New to add the new sample to a new sample group. If no sample group information is retrieved, then Create New defaults as selected.
Click OK to continue. The Spec, Version, and Grade display for the specification selected.
Identity
Enter the Quality Laboratory as the inventory organization where the sample is tested.
Quantities
The Update Inventory Quantity indicator is selected when the sample transaction updates the amount of sample in inventory. When you enter a specification, Update Inventory Quantity is set to the value on the specification validity rule.
Enter the sample Quantity in its inventory UOM. This is the item primary UOM, or another UOM with a valid conversion.The value defaults from the quantity entered on any associated sampling plan. Required.
Remaining Quantity displays the balance of sample remaining after the actual test quantities are deducted at the time of result entry. UOM displays the unit of measure. It is expressed in the same UOM as the sample quantity.
Dates
Enter Drawn as the date and time the sample was taken. This field defaults to the current system date and time. Required.
Retrieved displays the date and time the stability sample was pulled from storage for testing by the quality laboratory. This date defaults from the stability study.
Enter Received as the date and time the sample was received for testing by the quality laboratory.
Enter Required as the date and time when the sample analysis must be completed.
Enter Expired as the date and time when the sample expires.
Sample Group
The following fields for the sample group are display only:
Sample Instance is the sample iteration with respect to the total number of samples in the sample group based on the samples taken.
Samples Taken is the total number of samples already taken for the sample group.
Samples Required is the total number of samples required in the sample group based on the sampling plan requirement.
Storage
Enter External ID as an alternate or cross-reference code for the sample. For example, if the sample is recorded on another test database, then enter the sample ID recorded on the external system.
Select a Storage Organization as the inventory organization where the sample is stored.
Enter Storage Subinventory as the subinventory where the remaining sample quantity is stored. The description of the storage subinventory displays. If the item is restricted, then the storage subinventory is restricted. Query item samples by storage subinventory and locator using the Sample Storage Summary inquiry.
Enter a Storage Locator for the sample. If the sample storage locator is:
Restricted, then a valid locator must be entered for the specified storage subinventory. The LOV displays valid locators for the Storage Subinventory entered.
Non-restricted, then you do not have to specify a valid locator for the specified storage subinventory. Enter a storage locator in this field; however there is no LOV.
This field is protected from entry if the storage subinventory does not exist for the locator. If a Storage Subinventory is entered, then this field is required.
Note: Restricted subinventories indicate whether to restrict transactions of an item to or from a subinventory specified in a list you define using the Item/Subinventory Information window in Oracle Inventory. Restricted locators indicate whether to restrict a transaction of the item to or from a locator specified in the list you define using the Item/Subinventory Information window in Oracle Inventory. You cannot restrict locators unless you also restrict subinventories.
Approvers
Enter the Sampler as a code for the individual who withdrew the sample. The name of the individual appears in the field next to this code. This field defaults to the current user.
Note: If you intend to set up workflow and Oracle E-Records events against samples, then do not enter Sampler, Sample Approver, or Inventory Approver. Refer to "Appendix D" for additional information.
Enter the Sample Approver as the individual who is responsible to approve the sample.
Enter the Inventory Approver as the individual who can approve the item to release to production.
Composite Results
If the sample belongs to a sample group with composited results, then the Composite Results tab is enabled. The following fields are display only:
Specification indicates the specification name used for the composite results.
Version indicates the specification version used for the composite results.
Grade indicates the grade defined by the specification displayed.
Validity Rule Use indicates the type of validity rule in use to composite the results.
Date Composited indicates the date and time the composite results were saved.
Disposition indicates the disposition of the sample based on the composite results.
Click View to display the Composite Results window for this sample.
Spec Disposition
If the specification associated to the sample was replaced through specification comparison, then the history of sample dispositions against each specification displays. The following fields are display only:
Specification indicates the specification name associated to the sample.
Version indicates the specification version.
Grade indicates the grade assigned to the specification displayed.
Disposition indicates the disposition of the sample with respect to the specification displayed.
Validity Rule Use indicates the type of specification validity rule used.
Control Lot Attributes indicates if a lot status, and optionally a grade is dependent on the specification displayed.
Comments
Enter Comments for the sample.
Save the window.
Navigate to the Item Samples window. The context organization displays in the window title. Select a different organization using the Organizations window.
Enter the Sample. If automatic sample numbering is selected, and the sample is a new record, then the Sample field is blank and disabled until the record is saved, at which point a sample number is assigned. Otherwise, enter the number. Use automatic sample numbering for samples generated in a stability study. Required.
Enter the Disposition as the sample status:
Planned when the sample is scheduled to be taken.
Retain when the sample is taken and put in storage. Results cannot exist for a sample with this disposition.
Pending when the sample is saved, and results are expected, but not yet recorded. This is the default disposition.
Cancel when the sample is canceled.
Required.
Refer to "Understanding Sampling" for an explanation of how to change sample disposition.
Enter a Description for the sample. If you do not enter a description, then the item description defaults from the item entered.
If Retain is the disposition, then enter Retain As to indicate whether the sample type is an Archive, or Reserve sample.
Enter the Item as the process quality-enabled item sampled. A description of the item entered displays. Required.
Enter the item Revision. If the item is not revision-controlled, then this field is disabled. Required.
Enter a Priority for the sample 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.
Select the sample Source as WIP.
Enter Batch as the batch number for the WIP sample.
If the sample is created through the Sample Creation Notification workflow, then the following defaults as the sample source:
Batch number
Batch step, if applicable
Recipe number and version
Formula number and version
Routing number and version
Operation number and version
If the sample is created manually, then one of the following is required for the sample source:
Batch number, if the sample is created in a plant or lab organization.
Recipe number and version, if the sample is created in a lab organization.
Note: If a batch is specified, then the material detail line is used instead of the formula line.
Enter the Line as the line sequence for the item listed in the batch or formula.
Type defaults from the material or formula line entered, and indicates the type of consumption or yield that is applicable to the formula line.
Enter the Step as the batch step, if it is applicable.
Enter the step Charge as the charge controlled by the listed specification.
Enter the Subinventory where the WIP item is yielded and the sample is taken.
Enter the Locator if the subinventory exists for the locator and the item is locator controlled. Locator control is defined at the organization, subinventory, or item level, in that order.
Enter the sample item Parent Lot code if the item is child lot-controlled. Refer to "Understanding Parent Lots and Lots" for detailed information on parent lots and lots.
Enter the sample item Lot code. Edit this field if the item specified is lot-controlled. If Lot Optional On Samples is selected on the specification validity rule associated to the sample or if you enter a parent lot, then Lot is not required.
Enter the LPN for the WIP sample to consume. You can select the LPN from the LOV. This field is enabled only for WMS enabled organizations.
Enter the Recipe and version if the sample is created in a lab organization and a batch number is not entered.
Formula displays the formula used in the batch and its version. If a recipe is entered. then these fields default.
Routing displays the routing used in the batch and its version. If a batch is entered, then routing and routing version default from the batch. If a valid recipe is entered, then the routing associated to the recipe displays. You cannot change these fields.
Operation displays the operation and version associated to the routing and step displayed. These fields are blank if a routing and step are not entered.
Note: If the sample was previously associated to a specification using the Sample Creation Notification workflow, then the Get Spec function is disabled. You can also save a sample without having a specification associated to it.
Click Get Spec to associate a specification for this sample. The Specification Association dialog box displays.
Select one of the following:
Use Default displays the specification, version, and grade with a specification validity rule that exactly or best matches the sample source information entered. This depends on the value entered for the process quality parameter Exact Spec Match in the Process Quality Parameters window. Select Exact Spec Match if a specification needs to be an exact match. If a specification does not need an exact match, then deselect. The best match is based on the specification matching hierarchy described in "Specification Matching Business Rules" found in "Appendix B."
Use Alternate to select a specification that is different from the default specification for the sample. Select from a list of applicable specifications chosen from the specification matching hierarchy. This list is ordered based on the most specific to most generic match. If you select Use Alternate, then select the Spec as the alternate specification to use. The current Version and Grade display.
Note: The Created On, Samples Taken, and Samples Required fields display if there is an existing sample group that matches the sample source and specification selected. Deselect Create New to add the new sample to the existing sample group. Select Create New to add the new sample to a new sample group. If no sample group information is retrieved, then Create New defaults as selected.
Click OK to continue. The specification Name, Version, and Grade display for the specification selected.
Note: The Identity, Storage, Approvers, Composite Results, Spec Disposition, and Comments tabs have the same field definitions as those that appear in the "To enter an inventory sample" task. Refer to that task for this information.
Save the window.
Navigate to the Item Samples window.
Enter the Sample. If automatic sample numbering is selected, and the sample is a new record, then the Sample field is blank and disabled until the record is saved, at which point a sample number is assigned. Otherwise, enter the number. Required.
Enter the Disposition as the sample status:
Planned when the sample is scheduled to be taken.
Retain when the sample is taken and put in storage. Results cannot exist for a sample with this disposition.
Pending when the sample is saved, and results are expected, but not yet recorded. This is the default disposition.
Cancel when the sample is canceled.
Required.
Refer to "Understanding Sampling" for an explanation of how to change sample disposition.
Enter a Description for the sample. If you do not enter a description, then the item description defaults from the item entered.
If Retain is the disposition, then enter Retain As to indicate whether the sample type is an Archive or Reserve sample.
Enter Item as the process quality-enabled item sampled. A description of the item entered displays. Required.
Enter the item Revision. If the item is not revision-controlled, then this field is disabled. Required.
Enter a Priority for the sample 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.
Select the sample Source as Supplier.
Enter the Supplier number. Required.
Enter the Operating Unit corresponding to the supplier site. The operating unit must have an Oracle Process Manufacturing (OPM) fiscal policy to indicate that it is used for process manufacturing.
Enter the Supplier Site as the supplier site code that appears on the corresponding purchase order.
If the sample is associated to a purchase order, then enter the PO Number and Line number.
If the sample is associated to a receipt, then enter the Receipt number and receipt Line number.
Enter the receiving Subinventory and Locator for the material.
Enter the sample item Parent Lot code if the item is child lot-controlled. Refer to "Understanding Parent Lots and Lots" for detailed information on parent lots and lots.
Enter the sample item Lot code. Edit this field if the item you specified is lot-controlled. If Lot Optional On Samples is selected on the specification validity rule associated to the sample, then Lot is not required .
Enter the LPN for the Supplier sample to consume. You can select the LPN number from the LOV. This field is enabled only for WMS enabled organizations.
Enter the Supplier Lot number.
Note: If the sample was previously associated to a specification using the Sample Creation Notification workflow, then the Get Spec function is disabled. If any sample source fields (Lot, Subinventory, or Locator) are changed, then the Spec, Version, and Grade fields are cleared. You can also save a sample without having a specification associated to it.
Click Get Spec to associate a specification for this sample. The Specification Association dialog box displays.
Select one of the following:
Use Default displays the specification, version, and grade with a specification validity rule that exactly or best matches the sample source information entered. This depends on the process quality parameter Exact Spec Match in the Process Quality Parameters window. Select Exact Spec Match if a specification needs to be an exact match. If a specification does not need an exact match, then deselect. The best match is based on the specification matching hierarchy described in "Specification Matching Business Rules" found in Appendix B.
Use Alternate to select a specification that is different from the default specification for the sample. Select from a list of applicable specifications chosen from the specification matching hierarchy. This list is ordered based on the most specific to most generic match. If you select Use Alternate, then select the Spec as the alternate specification to use. The current Version and Grade display.
Note: If there is an existing sample group that matches the sample source and specification selected, then the Created On, Samples Taken, and Samples Required fields display. Deselect Create New to add the new sample to the existing sample group. Select Create New to add the new sample to a new sample group. If no sample group information is retrieved, then Create New defaults as selected.
Click OK to continue. The specification Name, Version, and Grade display for the specification selected.
Note: The Identity, Storage, Approvers, Composite Results, Spec Disposition, and Comments tabs have the same field definitions as those that appear in the "To enter an inventory sample" task. Refer to that task for this information.
Save the window.
Navigate to the Item Samples window.
Enter the Sample. If automatic sample numbering is selected, and the sample is a new record, then then the Sample field is blank and disabled until the record is saved, at which point a sample number is assigned. Otherwise, enter the number. Use automatic sample numbering for samples generated in a stability study. Required.
Enter the Disposition as the sample status:
Planned when the sample is scheduled to be taken.
Retain when the sample is taken and put in storage. Results cannot exist for a sample with this disposition.
Pending when the sample is saved, and results are expected, but not yet recorded. This is the default disposition.
Cancel when the sample is canceled.
Required.
Refer to "Understanding Sampling" for an explanation of how to change sample disposition.
Enter a Description for the sample. If you do not enter a description, then the item description defaults from the item entered.
If Retain is the disposition, then enter Retain As to indicate whether the sample type is an Archive, or Reserve sample.
Enter Item as the process quality-enabled item sampled. A description of the item entered displays. Required.
Enter the item Revision, if the item is revision-controlled. If the item is not revision-controlled, then this field is disabled. Required.
Enter a Priority for the sample 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.
Select the sample Source as Customer.
Enter the Customer name. Required.
Enter the Operating Unit corresponding to the ship-to or bill-to location. The operating unit must have an OPM fiscal policy to indicate that it is used for Process Manufacturing.
Enter one or both of the following fields only if you enter an operating unit:
Ship-To to indicate the ship-to location for the specified customer and operating unit.
Order to indicate the order number. If you enter an order number, then Type displays the sales order type code from those set up for the operating unit in the Oracle Order Management application.
If you did not enter an operating unit, then leave both of these fields blank.
Enter the Line associated to the order.
Enter the sample item Parent Lot code if the item is child lot-controlled. Refer to "Understanding Parent Lots and Lots" for detailed information on parent lots and lots.
Enter the sample item Lot code. If the item you specified is lot-controlled, then edit this field. If Lot Optional On Samples is selected on the specification validity rule associated to the sample, then Lot is not required.
Note: If the sample was previously associated to a specification using the Sample Creation Notification workflow, then the Get Spec function is disabled. You can also save a sample without having a specification associated to it.
Enter the LPN for the Customer sample to consume. You can select the LPN from the LOV. This field is enabled only for WMS enabled organizations.
Click Get Spec to associate a specification for this sample. The Specification Association dialog box displays.
Select one of the following:
Use Default displays the specification, version, and grade with a specification validity rule that exactly or best matches the sample source information entered. This depends on the process quality parameter Exact Spec Match in the Process Quality Parameters window. Select Exact Spec Match if a specification needs to be an exact match. Deselect if a specification does not need an exact match. The best match is based on the specification matching hierarchy described in "Specification Matching Business Rules" found in Appendix B.
Use Alternate to select a specification that is different from the default specification for the sample. Select from a list of applicable specifications chosen from the specification matching hierarchy. This list is ordered based on the most specific to most generic match. If you select Use Alternate, then select the Spec as the alternate specification to use. The current Version and Grade display.
Note: The Created On, Samples Taken, and Samples Required fields display if there is an existing sample group that matches the sample source and specification selected. Deselect Create New to add the new sample to the existing sample group. Select Create New to add the new sample to a new sample group. If no sample group information is retrieved, then Create New defaults as selected.
Click OK to continue. The Spec, Version, and Grade display for the specification selected.
Note: The Identity, Storage, Approvers, Composite Results, Spec Disposition, and Comments tabs have the same field definitions as those that appear in the "To enter an inventory sample" task. Refer to that task for this information.
Save the window.
You cannot enter a stability study sample on the Item Samples window. However, you can display information about it.
Navigate to the Variants window.
Query the stability Study with the desired sample.
Select the variant Num that has the sample to view.
Click Time Points.
Select the Time Interval that has the sample to view.
Click Samples.
Select the sample to view.
Click View Sample.
The Item Samples window displays the desired variant time point sample.
The following fields are display only:
Disposition displays the sample status or disposition as:
Planned when the sample is scheduled to be taken.
Pending when the sample is saved, and results are expected, but not yet recorded. This is the default disposition.
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.
Retain when the sample is taken and put in storage. Results cannot exist for a sample with this disposition.
Cancel when the sample is canceled.
Description displays a description of the time point sample for the sample.
Retain As indicates whether the sample type is an Archive, Reserve, or required sample.
Item displays the process quality-enabled item sampled and its description.
Revision displays the item revision, if the item is revision-controlled.
Source is Stability Study.
Study is the organization and study number.
Variant displays the variant sampled.
Time Point displays the variant time point sampled.
Scheduled displays the date and time the sample is scheduled for testing.
Note: The Identity, Approvers, Composite Results, Spec Disposition, and Comments tabs have the same field definitions as those that appear in the "To enter an inventory sample" task. Refer to that task for this information.
Storage
The following fields are display only:
Storage Organization displays the process quality-enabled inventory organization where the stability study sample is stored.
Storage Subinventory displays the storage subinventory for the variant time point sample.
Storage Locator displays the variant time point sample.
Resource displays the storage resource specified on the storage condition plan for the variant time point sample.
Instance displays the specific resource instance identified for the storage condition specified in the monitoring specification for the variant time point sample.
Choose Mark for Purge from the Actions menu. The sample is marked for deletion.
Choose Edit Text from the Actions menu. The Select Text Paragraph window displays.
Make appropriate text changes.
Save the window.
Click Spec Comparison to compare specifications. Refer to "Specification Comparison" for additional information.
Choose Change Disposition from the Actions menu.
Enter the new sample disposition.
If the current sample completes testing for the entire sample group, then you can enter these additional fields if the Control Lot Attributes indicator is selected on the specification validity rule:
Enter Change Lot Status To as the new or revised lot status.
Note: To change the lot status of a sample that belongs to a sample group with more than one sample, you will first need to change the quality disposition using Composite Results button in the Sample Groups window.
Enter Change Grade To as the new or revised grade.
Enter Reason Code as a valid reason code for the change.
Enter Hold Date as the new or revised lot hold release date.
Select the recommended test results to store the lot-specific UOM conversion factors if Calculate UOM Conversion is selected on tests from the associated specification. Refer to "Using Lot UOM Conversions Based on Quality Results" for additional information.
Save the window.
Query the sample with the disposition Retain.
Change the sample disposition to Pending.
For Retain As Archive samples, optionally select Schedule Spec Tests to assign tests from the associated specification upon request for investigation.
For Retain As Archive samples, the disposition remains as Retain and you cannot change it to Pending. Reserve samples can be selected for additional test quantities when testing against a required sample.
Navigate to the Results window to enter results for the sample when they become available. Refer to "Understanding Retained, Archive, and Reserve Samples" for detailed information.
You can choose Results from the Actions menu, or click Results to display the Results window.
When a batch is terminated, the Sample Creation Workflow notifications that are open are canceled. Manage any samples that are created against the batch.
The Monitoring Samples window lets you create a sample against a locator or resource using the monitoring specification that is associated to it. The monitoring sample provides the information needed to evaluate the acceptability of environmental conditions for each variant storage condition in a stability study. Take these samples for tests defined in a monitoring specification. A monitoring sample is defined for:
Organization, subinventory, locator to monitor a specific storage locator that needs to maintain a defined quality environment. For example, define FREEZER as a locator in subinventory WH1 to sample its temperature and humidity.
Organization, resource, resource instance to monitor a specific storage resource that needs to maintain a defined quality environment. For example, define the resource CHAMBER, and the resource instance SERIALNUM-1000 to identify the specific environmental chamber used in a stability study.
Monitoring samples cannot have a disposition of Retained.
Set up a quality lab organization where sample testing is performed.
Optionally, select Exact Spec Match in the Process Quality Parameters window.
Enter tests, and create an approved specification and specification validity rule for sampling.
Set up document numbering for the organization in which you take samples using Assignment Type in the Process Quality Parameters window.
Optionally, enter a sampling plan.
Navigate to the Monitoring Samples window. The context organization displays in the window title. Select a different organization using the Organizations window.
Enter the Sample. If automatic sample numbering is selected, and the sample is a new record, then the Sample field is blank and disabled until the record is saved, at which point a sample number is assigned. Otherwise, enter the number. Required.
Enter the Disposition as the sample status or disposition as:
Planned when the sample is scheduled to be taken.
Pending when the sample is saved, and results are expected, but not yet recorded. This is the default disposition.
Cancel when the sample is canceled.
Required.
Refer to the "Understanding Sampling" topic for an explanation of how to change sample disposition.
Enter a Description for the monitoring sample.
Select the sample Source as Physical Location. Required.
Enter a Priority for the sample 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.
Enter the Subinventory for the monitoring sample.
Enter the Locator in the subinventory for the monitoring sample.
Click Get Spec to retrieve the specification for this sample. The Specification Association dialog box displays.
Select one of the following:
Use Default displays the specification and version with a specification validity rule that exactly or best matches the sample source information entered. This depends on the process quality parameter Exact Spec Match in the Process Quality Parameters window. Select Exact Spec Match if a specification needs to be an exact match. If a specification does not need an exact match, then deselect. The best match is based on the specification matching hierarchy described in "Specification Matching Business Rules" found in "Appendix B".
Use Alternate to select a specification that is different from the default specification for the sample. Select from a list of applicable specifications chosen from the specification matching hierarchy. This list is ordered based on the most specific to most generic match. If you select Use Alternate, then select the Spec as the alternate specification to use. The current Version and Grade display.
Note: The Created On, Samples Taken, and Samples Required fields display if there is an existing sample group that matches the sample source and specification selected. Deselect Create New to add the new sample to the existing sample group. Select Create New to add the new sample to a new sample group. If no sample group information is retrieved, then Create New defaults as selected.
Click OK to continue.
Name displays the effective default specification that best matches the sample source information, or the alternate you selected.
Version displays the version of the specification selected.
Identity
Enter the Quality Laboratory as the organization where the sample is tested.
Dates
Enter Drawn as the date and time the sample was taken. This field defaults to the current date and time.
Enter Received as the date and time the sample was received for testing.
Enter Required as the date and time when the sample is required to be taken.
Storage
Enter External ID as an alternate or cross-reference code for the sample. For example, if the sample is recorded on another test database, then enter the sample ID recorded on the external system.
Comments
Enter Comments for the sample.
Save the window.
Navigate to the Monitoring Samples window. The context organization displays in the window title. Select a different organization using the Organizations window.
Enter the Sample. If automatic sample numbering is selected, and the sample is a new record, then the Sample field is blank and disabled until the record is saved, at which point a sample number is assigned. Otherwise, enter the number. Required.
Enter the Disposition as the sample status:
Planned when the sample is scheduled to be taken.
Pending when the sample is saved, and results are expected, but not yet recorded. This is the default disposition.
Cancel when the sample is canceled.
Required.
Refer to "Understanding Sampling" for an explanation of how to change sample disposition.
Enter a Description for the monitoring sample.
Select the sample Source as Resource. Required.
Enter the Resource for the monitoring sample.
Enter the resource Instance for the monitoring sample.
Refer to the Oracle Process Manufacturing Planning user's guides for detailed information on entering resource information linked to the resource instance that identifies it.
Enter a Priority for the sample 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.
Click Get Spec to retrieve the specification for this sample. The Specification Association dialog box displays.
Select one of the following:
Use Default displays the specification and version having a specification validity rule that best matches the sample source information entered. This match is based on the specification matching hierarchy described in "Specification Matching Business Rules" found in "Appendix B."
Use Alternate to select a specification that is different from the default specification for the sample. Select from a list of applicable specifications chosen from the specification matching hierarchy. This list is ordered based on the most specific to most generic match. If you select Use Alternate, then select the Spec as the alternate specification to use. The current Version and Grade display.
Note: The Created On, Samples Taken, and Samples Required fields display if there is an existing sample group that matches the sample source and specification selected. Deselect Create New to add the new sample to the existing sample group. Select Create New to add the new sample to a new sample group. If no sample group information is retrieved, then Create New defaults as selected.
Click OK to continue.
Name displays the effective default specification that best matches the sample source information, or the alternate selected.
Version displays the version of the specification selected.
Identity
Select the Quality Laboratory as the organization where the sample is tested.
Dates
Enter Drawn as the date and time the sample was taken. Defaults to the current date and time.
Enter Received as the date and time the sample was received for testing.
Enter Required as the date and time when the sample is required to be taken.
Storage
Enter External ID as an alternate or cross-reference code for the sample. For example, if the sample is recorded on another test database, then enter the sample ID recorded on the external system. This field is for informational purposes only.
Comments
Enter Comments for the sample.
Save the window.
Choose Mark for Purge from the Actions menu. The sample is marked for deletion.
Choose Edit Text from the Actions menu. The Select Text Paragraph window displays.
Make appropriate text changes.
Save the window.
Choose Change Disposition from the Actions menu.
Enter the new sample disposition.
Save the window.
Choose Results from the Actions menu, or click Results to display the Results window.
Click Specification. The Specifications window displays the monitoring specification.
Click Spec Validity Rule. The Validity Rules for Monitoring Spec window displays the monitoring specification validity rules.
The Find Samples dialog box lets you find a sample by item, revision, parent lot, lot, disposition, priority, source, date and time drawn, specification, grade, quality laboratory, storage subinventory and locator, or external ID.
Enter and save a sample.
Navigate to the Find Samples dialog box. The process-enabled context organization displays in the window title. Select an organization using the Organizations window.
Enter any of the following to narrow your search:
Sample code as the combination of the three-letter organization code and sample document number.
Item code as the process quality-enabled item associated to the sample.
Revision as the item revision, if the item is revision-controlled.
Parent Lot as the sample parent lot, if the item is child lot-controlled.
Lot as the sample lot, if the item is lot-controlled.
LPN as the LPN number for the sample. You can select the LPN number from the LOV. This field is enabled only for WMS enabled organizations.
Disposition of the sample as Pending, In Progress, Complete, Accept, Accept with Variance, Reject, Retain, or Cancel. If you leave this field blank, then it does not include sample disposition in the search.
Retain As to indicate whether the item sample was retained as an Archive or Reserve sample.
Priority of the sample as Normal, Low, or High. If you leave this field blank, then it does not include sample priority in the search.
Select one of the following as sample Source:
Customer to indicate that the sample source is for a customer sample. Enter Customer, Operating Unit, Customer Location, and Line.
Inventory to indicate that the sample source is for an inventory sample. Enter Subinventory and Locator.
Supplier to indicate that the sample source is for a supplier sample. Enter Supplier, Supplier Site, Operating Unit, Supplier Lot, Purchase Order number and Line, and Receipt and Line.
Stability Study to indicate that the sample source is for a stability study sample. Enter Study Name, Variant, Time Point, Scheduled, and Date Retrieved.
WIP to indicate that the sample source is for a work in process sample. Enter Batch, Recipe and its Version, Routing and its Version, Step, Charge, Operation and its Version, and Formula and its Version.
The fields listed in this step for each source type are described in the "Entering Samples" topic.
To narrow the search to a specific time interval that samples were drawn:
Enter the Date Drawn From field as the starting date and time for the search.
Enter the To field as the ending date and time for the search.
Enter the Specification, its Version, and an optional Grade for the search.
Enter the Quality Laboratory for sample processing.
Enter the Storage Organization for the sample.
Enter the Storage Subinventory for the sample.
Enter the Storage Locator for the sample.
Enter the External ID for the sample.
Select Marked for Deletion Yes to find samples that are marked for deletion. Select No to find samples that are not marked for deletion. If you do not want to limit your search based on whether a sample is marked for deletion, then leave this field blank.
Click Find. The Item Samples window displays the results of the search.
Enter any of the following to narrow your search:
Sample code as the combination of the three-letter organization code and sample document number.
Disposition of the sample as Pending, In Progress, Complete, Accept, Accept with Variance, Reject, Retain, or Cancel. If you leave this field blank, then it does not include sample disposition in the search.
Priority of the sample as Normal, Low, or High. If you leave this field blank, then it does not include sample priority in the search.
Select one of the following as sample Source:
Physical Location to indicate that the sample source is for a locator sample. Enter the Subinventory and Locator.
Resource to indicate that the sample source is for a resource sample. Enter the Resource and Resource Instance.
The fields listed in this step for each source type are described in the "Entering Samples" topic.
To narrow the search to a specific time interval that samples were drawn:
Enter the Date Drawn From field as the starting date and time for the search.
Enter the To field as the ending date and time for the search.
Enter the Specification and its Version.
Enter the Quality Laboratory for sample processing.
Enter Storage Organization as the process quality-enabled inventory organization where the physical location or resource monitoring sample is stored.
Enter the Storage Subinventory for the sample.
Enter the Storage Locator for the sample.
Enter the External ID for the sample.
Select Marked for Deletion as Yes to find samples that are marked for deletion. Select No to find samples that are not marked for deletion. If you do not want to limit your search based on whether a sample is marked for deletion, then leave this field blank.:
Yes to find samples that are marked for deletion.
No to find samples that are not marked for deletion.
Leave this field blank if you do not want to limit your search based on whether a sample is marked for deletion.
Click Find. The Monitoring Samples window displays the results of the search.
Click New. The Monitoring Samples window displays.
Create a new sample as described in the "Entering Samples" topic.
The Sample Groups window lists all existing sample groups that share common sampling information. The query function lets you filter the sample groups of interest. For a selected sample group, view or add samples in the sample group. Create or view composite results for a sample group.
Create samples.
Complete testing and enter results for the samples.
Navigate to the Sample Groups window. The Find Sample Groups dialog box displays. The context organization displays in the window title. Select an organization using the Organizations window.
Enter any of the following to narrow your search:
Sample as the sample number.
Item as the item number sampled.
Revision as the item revision, if the item is revision-controlled.
Parent lot as the parent lot number of the item sampled.
Lot as the lot number sampled, if the item is lot-controlled.
LPN as the LPN number for the sample group. You can select the LPN number from the LOV. This field is enabled only for WMS enabled organizations
Source
Click Find. The following fields are display only on the Sample Groups window:
Source indicates whether the sample source is Customer, Inventory, Locator, Resource, Supplier, Stability Study, or WIP.
Creation Date indicates the date and time of sample group creation.
Item indicates the process quality-enabled item sampled and its Description.
Revision indicates the item revision, if the item is revision-controlled.
Parent Lot indicates the parent lot number of the item sampled, if the item is child lot-controlled.
Lot indicates the lot number sampled, if the item is lot-controlled.
LPN indicates the LPN number for the sample group.
Disposition indicates the sample group disposition as Planned, Retain, Pending, In Progress, Complete, Accept, Accept with Variance, or Reject.
Samples
Required indicates the total number of samples required in the sample group based on the sampling plan requirement.
Taken indicates the total number of samples taken for the sample group based on the sampling plan requirement.
Lot Retest indicates selected if the sample group is taken for lot retesting. This defaults from the Lot Expiry/Retest Notification workflow if it is used.
Archived Taken indicates the total number of archived samples taken.
Reserved Taken indicates the total number of reserved samples taken.
The following fields are display only for a customer sample source:
Customer Name indicates the name of the customer.
Operating Unit indicates the operating unit.
Order indicates the order number.
Line indicates the order line number.
Customer Location indicates a ship-to or bill-to location.
The following fields are display only for an inventory sample source:
Subinventory is the inventory subinventory code.
Locator is the inventory locator code.
The following fields are display only for a physical location monitoring sample source:
Subinventory indicates the subinventory for the monitoring sample.
Locator indicates the locator in the subinventory for the monitoring sample.
The following fields are display only for a resource monitoring sample source:
Resource indicates the resource for the monitoring sample.
Instance indicates the specific instance for the monitoring sample.
The following fields are display only for a supplier sample source:
Supplier is the supplier code.
Supplier Site indicates the supplier site number.
Operating Unit indicates the operating unit.
Supplier Lot indicates the supplier lot number.
Purchase Order indicates the purchase order number.
Line indicates the purchase order line.
Receipt is the receipt number.
Line is the receipt line number.
The following fields are display only for a stability study sample source:
Study indicates the stability study name.
Variant indicates the variant for the sample group.
Time Point indicates the time point tested for the sample group.
Schedule Date From indicates the scheduled start date and time for drawing the sample group based on the stability study scheduled start date.
Schedule Date To indicates the scheduled date and time for drawing the sample group based on the stability study scheduled end date.
The following fields are display only for a WIP sample source:
Batch indicates the batch document number.
Recipe indicates the recipe used in the batch and its Version.
Routing indicates the routing that is associated to the recipe used in the batch and its Version.
Step indicates the step number in the batch.
Charge indicates the charge number in the step.
Operation indicates the operation in the routing and its Version.
Select the Sample Group to add a sample.
Click Add Sample. The Item Samples or the Monitoring Samples window displays, depending on the sample source.
Refer to the "Entering Samples" topic for more information on creating a sample.
Save the window.
Select the Sample Group that has the sample.
Click View Samples.
Scroll through the samples to view the sample details.
Select the Sample Group to composite, or that has existing composite results to view.
Click Composite Results.
Refer to "Compositing Test Results" for information on compositing a results set.
Save the window.
Enter any of the following to narrow your search:
Sample
Item
Revision
Parent lot
Lot
LPN as the LPN number for the sample.
Source
Click Find.
Refer to the "Finding Samples" for a discussion of these fields.
Select the sample group that has the samples to process.
Click Mass Results. The Test and Description display for each test.
Enter the Tester as the individual who enters results. Defaults to your current organization. Required.
Enter the Result Date as the date and time the result was entered. Defaults to the current system date and time. Required.
Click Select All to select all tests, or Select the tests to enter for the sample group. Deselect Select to remove tests you do not want to enter for the sample group.
Click Mass Results Entry. The Mass Results Entry window displays to enter test results for all samples selected. You cannot enter mass results for archive or reserve sample types.
The Samples By... windows let you display summaries of item samples sorted by organization, item, disposition, test, test class, test method, and laboratory.
You can use flexfields and folders with this window.
See: Oracle Applications User's Guide and Oracle Applications Flexfields Guide
Enter and save samples.
Navigate to the Quality Workbench.
Select Show Active Samples to display only those samples that are active. Active samples are defined as those samples that have a disposition of Pending or In Progress. Deselect this indicator to display item samples with all sample dispositions.
Select View By Organization, Item, Disposition, Test, Test Class, Test Method, or Laboratory to sort samples by organization, item, disposition, test, test class, test method, or laboratory.
Expand the node, and select the desired Samples By... window.
Drill down to item samples and results.
The following fields are display only on the Samples By... windows:
Sample displays the sample number.
Mass Results Entry indicates whether you can enter mass results for the sample group.
Item displays the code for the material being specified as it is listed on the Item Master in Oracle Inventory. The item must be set up as process quality-enabled.
Date Drawn displays the date and time the sample was taken.
Revision displays the item revision, if the item is revision-controlled.
Disposition displays the sample disposition as:
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.
Reject when sample testing is complete, and results are not acceptable, or out-of-specification.
Retain when the sample is taken and put in storage. Results cannot exist for a sample with this disposition.
Retain As indicates whether the sample type is an Archive, Reserve, or required sample.
Source displays Customer, Inventory, Monitoring, Supplier, Stability Study, or WIP to indicate the sample source.
Parent Lot displays the sample parent lot, if the item is child lot-controlled.
Lot displays the sample lot.
LPN displays the LPN number for the sample.
Specification displays the item specification.
Specification Version displays the item specification version.
Grade displays the grade associated to the item specification.
Sample Quantity displays the sample quantity taken.
Sample UOM displays the inventory unit of measure for the sample.
Remaining Quantity displays the quantity of the sample remaining from the original sample quantity taken.
Laboratory Organization displays the quality laboratory that analyzes the sample.
External ID displays an alternate or cross-reference code for the sample. For example, if the sample is recorded on another test database.
Source Comment displays the origin of the material sampled in addition to the sample source.
Expiration Date displays the sample expiration date and time.
Storage Organization displays the organization where the sample is stored.
Storage Subinventory displays the subinventory where the sample is stored.
Storage Locator displays the restricted or non-restricted storage locator for the sample.
Sampler displays the code for the individual that withdrew the sample.
Sample Instance displays the sample iteration with respect to the total number of samples in the sample group based on the applicable sampling plan.
Samples Required displays the total number of samples required in the sample group based on the sampling plan requirement.
Samples Taken displays the total number of samples already taken for the sample group. The position of this sample is indicated.
Lot Retest indicates whether the sample group is taken for lot retesting. This defaults from the Lot Expiry/Retest Notification workflow if it is used.
Click View Sample to display the Item Samples window for the selected sample.
Click Create Sample to display the Item Samples window where you can create a new sample.
Click Results to display the Results window.
Select Show Active Samples to display only those samples that are active. Active samples are defined as those samples that have a disposition of Pending or In Progress. Deselect this indicator to display item samples with all sample dispositions.
Select View By Organization, Item, Disposition, Test, Test Class, Test Method, or Laboratory to sort samples by organization, item, disposition, test, test class, test method, or laboratory.
Expand the Samples By... node, and select the desired sample or sample group.
Click Mass Results Entry next to all samples that you want to select for entry of mass results. You cannot enter mass results for archive or reserve sample types.
Click Mass Results Entry to display the Mass Results Entry Test Selection window. The Test and Description display for each test.
Enter the Tester as the individual who enters results. Defaults to your current organization. Required.
Enter the Result Date as the date and time the result was entered. Defaults to the current system date and time. Required.
Click Select All to select all tests, or Select the tests to enter for the sample group. Deselect Select to remove tests you do not want to enter for the sample group.
Click Mass Results Entry. The Mass Results Entry window displays to enter test results for all samples selected. You cannot enter mass results for archive or reserve sample types.
The Samples Summary window displays a summary of samples by organization.
You can use flexfields and folders with this window.
Enter and save samples.
Navigate to the Samples Summary window. The context organization displays in the window title.
The following information is display only:
Organization
Sample
Sample Description
Click Mass Results Entry to display the Mass Results Entry Test Selection window. After selecting appropriate tests, click Mass Results Entry to display the Mass Results Entry window where you can enter test results.
The following fields are display only:
Item is the process quality-enabled item sampled.
Revision is the item revision, if the item is revision-controlled.
Item Description is the description on the Item Master.
Sample Description is the description of the sample.
Date Drawn is the date and time the sample was drawn.
Disposition is the current sample disposition.
Retain As indicates whether the sample type is an Archive, Reserve, or required sample.
Source is the sample source.
Parent Lot is the sample item parent lot code, if the item is child lot-controlled.
Lot is the sample item lot code.
Specification is the specification associated to the sample.
Specification Version is the specification version.
Grade displays the grade associated to the item specification.
Sample Quantity displays the sample quantity taken.
Sample UOM displays the inventory unit of measure for the sample.
Remaining Quantity displays the quantity of sample remaining from the original sample quantity taken.
Laboratory Organization displays the quality laboratory that analyzes the sample.
External ID displays an alternate or cross-reference code for the variant time point sample if the sample is recorded on another test database.
Source Comment displays the origin of the material sampled in addition to the sample source.
Expiration Date displays the sample expiration date and time.
Storage Organization displays the storage organization for the sample.
Storage Subinventory displays the storage subinventory for the sample.
Storage Subinventory displays the storage subinventory for the sample.
Storage Locator displays the restricted or non--restricted storage locator for the sample.
Sampler displays the code for the individual that withdrew the sample.
Sample Instance displays the sample iteration with respect to the total number of samples in the sample group based on the applicable sampling plan.
Samples Required displays the total number of samples required in the sample group based on the sampling plan requirement.
Samples Taken displays the total number of samples already taken for the sample group. The position of this sample is indicated.
Lot Retest is selected if the sample group is taken for lot retesting. This defaults from the Lot Expiry/Retest Notification workflow if it is used.
Note: Additional fields displayed on the window depend on the sample source, and are the same as the source information described in "Entering Item Samples." Refer to this topic for field definitions.
Select the sample group that has the samples to process.
Click Mass Results Entry. The Test and Description display for each test.
Enter the Tester as the individual who enters results. Defaults to your current organization. Required.
Enter the Result Date as the date and time the result was entered. Defaults to the current system date and time. Required.
Click Select All to select all tests, or Select the tests to enter for the sample group. Deselect Select to remove tests you do not want to enter for the sample group.
Click Mass Results Entry. The Mass Results Entry window displays to enter test results for all samples selected.