Following are some requirements that customers have for tests in Oracle Process Manufacturing (OPM) Quality Management:
Can a separate test be entered that calculates one or more tests performed on a sample?
Yes. Use the expression test data type to build a mathematical expression to reference the results of other numeric-based tests.
Build Mathematical Expressions in a Test Format:
Enter arithmetic operators such as +, -, *, /, (), exponents, constants, or any valid SQL operator to build an Expression test data type. Calculate the results of the Expression test after you enter results for all tests referenced in it. In case of replicated tests, the latest result of the referenced test is used. An Expression test can be added to a result set on an as needed basis if all of the referenced tests already exist in the result set. Decimal precision and experimental error regions and actions can be defined for an Expression test.
Can the actual method used to generate a test result be identified?
Yes. Test Methods let you describe how a test is performed, and help distinguish tests by their methods of execution.
Identify Test Methods Used to Generate Results:
Enter test methods to describe how a test is performed. A test method can refer to a test protocol or standard operating procedure. The test method is associated to the test during test definition. It facilitates the execution of quality tests by providing requirements for the quantity of test material, specific instrumentation to use for testing, number of replicates required, and the duration of the test.
Can testing resources be identified?
Yes. Associate instruments to test methods to identify testing resources to monitor in your planning application.
Develop Quality Procedures for Laboratory Instrumentation:
The quality laboratory is an inventory organization where sample analysis is performed. It contains resources or equipment that must be scheduled, calibrated, and evaluated for cost. You can define an instrument for quality testing purposes and associate it to a test method to support quality laboratory management and scheduling. OPM supports unique combinations of instrument and test method for a particular test, and you can perform a test in various ways using different laboratory equipment. Define laboratory instruments used for quality testing as generic resources in the OPM Planning application. Instrument resources are assigned at the organization level in the OPM Product Development application.
Is there flexibility in displaying decimals on-screen and in reports?
Yes. For numeric-based tests, the application saves and reports nine decimal places for each test result, specification target, minimum, maximum, and experimental error value. Specify decimal precision for displaying and saving results in the application by using the Display Decimal Precision field. Also, use the Report Decimal Precision field to specify the desired decimal precision for reporting results on a Certificate of Analysis.
Define Decimal Precision for Displayed and Printed Values:
Define decimal precision for Numeric Range, Numeric Range with Display, and Expression test data types. Test results are rounded based on the display precision specified at the test and specification levels. During test definition, define the reported decimal precision for specific customers.
Following are some requirements that were addressed in defining and managing specifications in Oracle Process Manufacturing (OPM) Quality Management:
Can several item specifications with the same set of tests, but different ranges be set up?
Yes. Define the specification for an item and grade to distinguish specifications with the same test requirements, but different limits or targets. Use base and overlay specification functionality to refine a series of specifications.
Enter the Item Grade on a Specification:
The entry of grade to grade-controlled item specifications facilitates the regrading of materials sampled and improves specification matching capabilities. Define several specifications for grade-controlled items. Compare results to these different specifications and change lot attributes under the appropriate circumstances. Use the overlay specification functionality to refine a series of specifications for an item as related to a base specification.
Is there a way to set up a test that needs to be performed several times on a sample?
Yes. Define the test replicate on the specification as the number of times the test needs to run.
Specify the Number of Test Replicates for a Test on a Specification:
To simplify data entry, test replicates are specified to denote the number of times a test should be performed on an instrument against the same sample. For example, if a test should be repeated three times on a sample, then the test can be defined on a single line of the specification record with a test replicate of three. The application adds result lines on the results record corresponding to the number of replicates specified on the applicable specification. For composite results and specification matching functionality, the result with the latest result date, acceptable value, and highest test replicate number is used.
Does every test on a specification have to be used for evaluating results?
No. Mark a test as Optional to indicate that it is not required to meet a specification. Use the Consider Optional Tests Results parameter in the Process Quality Parameters window to configure whether an optional test that appears on the specification and results records contributes to the final disposition of the sample.
See: "Setting Up Process Quality Parameters."
Mark Tests as Optional:
Mark a test as optional to indicate that it is not required to meet specification. Tests marked as optional are not considered when selecting available inventory that matches the customer specification. Results of these tests are not included in the compositing of results. However, if results are entered for optional tests, then they can be included in the results set when assigning a final sample disposition of Accept, Accept with Variance, or Reject. Optional tests are not considered when updating the sample disposition, or material status and grade. They cannot be used to control batch step status based on quality results. Use the Consider Optional Tests Results parameter in the Process Quality Parameters window to configure whether an optional test that appears on the specification and results records contributes to the final disposition of the sample. Refer to "Setting Up Parameters" for details. For example, a new test is measured over time but does not factor into sample dispositions until its test limits are formalized based on the results collected. If an optional test result must be used, then its result evaluation follows the existing business rules to change sample disposition. An out-of-specification result for an optional test only permits the sample disposition to change to Accept with Variance, Reject, or Cancel.
Can the tests required when a lot expires be identified?
Yes. A Lot Retest/Expiry indicator on the specification shows which tests need to be done when a lot expires.
Indicate the Purpose of Retesting:
The specification Lot Retest/Expiry indicator identifies which tests need to be performed when retesting an expired lot, or when retesting is required. An indicator also appears on the sample record to identify the purpose of retest. Send an electronic notification to create a sample based on the dates for lot retesting or lot expiration scenarios. The corresponding results record lists only the tests marked by the specification Lot Retest/Expiry indicator.
Can results that are printed on the Certificates of Analysis be controlled?
Yes. Set up certificate formatting options on the item specifications. The specification validity rule applies these options to the certificate type specified.
Choose Quality Certificate Formatting Options on the Specification:
Specify whether to print specification targets, limits, and results on a quality certificate when you define a specification. You can format the certificate for customers who receive these documents. The Specification Validity rule uses settings for these options.
Can specifications developed for internal versus external use be controlled?
Yes. Use specification validity rules to control item specifications developed for inventory, WIP, customer shipment, and supplier receipts. Configure the customer display on the Tests window and the report precision on individual specifications.
Validity Rules and Status Control Specification Use:
The item specification validity rule provides the specific information for how and when an item specification version applies to inventory, process execution, order management, and receiving operations. The item specification validity rule controls the:
Intended use of the specification, including inventory, WIP, customer, or supplier
Certificate of Analysis or Certificate of Conformance requirements at invoice, at shipment, or from supplier
Associated sampling plan
Inventory update for the sample quantity
Batch step completion based on quality sampling and results
Lot attributes update with default in-specification and out-of-specification material statuses, with the exception of the WIP item specification validity rule
Can customer test results on certificates they receive be formatted?
Yes. Select the certificate type on the specification validity rule.
Select the Certificate Type on the Item Specification Validity Rule:
Select the Certificate of Conformance or Certificate of Analysis on the item specification validity rule. You can specify the type of quality certificate to send to customers who receive these documents.
Following are some requirements that customers have for samples in Oracle Process Manufacturing (OPM) Quality Management:
Can the application help me plan sample collection?
Yes. Use the optional sampling plan to set up the sampling process in your facility. A Sample Creation Notification workflow helps manage the sample collection process. You can set up automatic sample creation so that the application creates planned sample records with the default sample group information such as batch, step, and item.
Use a Sampling Plan to Schedule Sample Collection:
Define both the sampling frequency and sample quantity with the optional sample plan that is set up prior to creating specifications and taking samples. Use the sampling plan with the Sample Creation Notification workflow. Use automatic sample creation when a lot is yielded to simplify data entry of production sampling in high volume production environments, or at various points in the supply chain.
Can I reserve a sample in case of sample breakage, leakage in transit to a testing facility, or future quality audits?
Yes. If you experience sample breakage, leakage, or spoiling during transit to a testing facility, then retain a reserve sample until testing is complete. For quality audits, retain an archive sample for future testing.
Reserve a Physical Sample without Testing:
Sometimes samples break or leak in transit to the testing facility. If you need the insurance of a replacement sample, then take an extra sample and mark it as Retain or Reserve. You can select reserve sample material during testing of the original sample. Create a Retain As Archive sample. If future testing is required, then change the disposition of this sample to Pending and send it for testing.
Can I track the lifecycle of a sample?
Yes. Record dates for when the sample is drawn and when it expires. If the sample is pulled from storage, specify the date and time it was retrieved, when the quality laboratory received it, and when analysis is due.
Enter Sample Dates to Track the Complete Sample Lifecycle:
Manage samples from the moment they are drawn and stored to when they are retrieved for testing. Enter additional dates for when analysis is required and when the sample expires. This helps you manage lab activities and ensures proper sample disposal.
Can I indicate which samples are designated for lot retesting purposes?
Yes. Select the Lot Retest/Expiry indicator for a sample when retesting an expired lot. Samples are marked appropriately to trace them in the storage subinventory if you need to retest the same material periodically.
Set the Lot Retest/Expiry Indicator to Indicate the Purpose of Retesting:
The Lot Retest indicator is included on the Sample record to identify the purpose of retest as a lot retest or expiration test. A notification can be sent to create a sample based on lot retesting or lot expiration requirements.
Can I track sample quantities after testing is completed?
Yes. Track the quantity of sample remaining based on the actual test quantities recorded. You can also track the physical storage subinventory and locator of a sample taken for quality testing purposes using the Sample Storage Summary inquiry.
Track Sample Quantities and Storage Locators:
Track remaining sample quantities on the Samples Summary window based on the actual test quantities recorded. Use the Sample Storage Summary inquiry to track the physical storage subinventory and locator for all your samples.
Following are some requirements that customers have for results in Quality Management:
Can individuals who perform tests be identified?
Yes. The Results window includes a Tester field for each specific test.
Identify Individual Testers Who Perform Tests:
The Results window includes a Tester field for each specific test. Each tester must be defined as a valid Oracle user. The application uses the Tester field to sort and group result data for:
Workflow notifications
Result entry
Activities for e-records and e-signatures
Can test quantities be tracked in testing:?
Yes. Manage the remaining sample quantity for testing based on actual test quantities used. Select a reserve sample if additional material is needed.
Manage Sample Quantity Used in Testing
You can determine the sample quantity remaining after testing, and select a reserve sample to retest when there is insufficient or questionable material available.
Can test kit materials be tracked in testing?
Yes. Test kit information is entered on the Results window. You can trace this material to its supplier and lot.
Identify Test Kit Item, or Lot Used in Testing:
For traceability purposes, test kit information is recorded on the Results window. This provides information about the material used in preparation or execution of a test. You can enter a test kit item as an inventory item in Oracle Inventory. In order to enter the test kit lot , the test kit item must be previously defined as a lot-controlled inventory item.
Is there a traceable record of external testing providers?
Yes. Identify the lab where the test is done by an internal laboratory, or the test provider where the test is sent to an external laboratory for testing.
Record External Test Provider Information:
Enter the facility where the test is done by an internal laboratory, or the enter the test provider where the test is sent to an external testing facility. Each test provider must be defined as a valid supplier.
Can retesting and resampling activities be enforced?
Yes. Retest and resample actions are designated upon reviewing results, so that a workflow notification can be sent to perform the test, or to take another sample.
Assign Retest and Resample Actions When Evaluating Results:
You can select a follow-up action on reviewing a test result. By associating existing action codes to the Retest and Resample Actions on the Process Quality Parameters window, the OPM Quality Testing and Sample Creation notifications are sent automatically. If the Retest Action is selected, then the test is added to the result set.
Can results be summarized using any statistical methods?
Yes. View the arithmetic mean, standard deviation, median, or range statistics for composite test results of numeric data, and the mode statistic for composite nonnumeric data.
Composite Test Results to Simplify Interpretation of the Results Set:
You can composite results from different samples of the same item lot within a sample group, and display individual sample results. The process of compositing results simplifies the determination and reporting of one final set of results from a set of multiple samples within a sample group.
When there are several test replicates for a test on a single sample, the most recent test replicate result is used in the composite result statistics. The result used cannot be canceled, voided, or marked for deletion. The application calculates result statistics for numeric-based tests, including:
Arithmetic mean
Median
Low, high, and range
Standard deviation
Mode
The Mode statistic is determined for List of Values and Text Range test types as the most frequently occurring result value. A user-definable value is enterable for Non-Validated test types.
This capability also provides options to exclude a sample or result, resample, or retest in order to derive the composite results set. You can save a new Results record that corresponds with the final set of composited results for an item and lot. The Certificate of Analysis prints the result average for each required numeric-based test that is not marked as optional on the specification.
Can lot status of an inspected item be updated automatically?
Yes. When you choose the Control Lot Attributes option, the lot status is updated automatically when all sample results are in-specification, or one of the results is out-of-specification.
Update Lot Status Automatically Based on Results:
The application evaluates sample results to determine conformance with the associated specification. Sample disposition is updated to Accept or Reject appropriately based on the test results. The default lot status specified on the specification validity rule is used to update the lot status of the item lot tested.
Can previously analyzed samples be compared to customer requirements?
Yes. Compare sample results to another quality specification to determine item conformance, and add appropriate tests to meet the specification used for comparison.
Compare a Sample to Another Specification:
You can compare a previously analyzed sample to another specification to determine whether the final results set meets the other specification requirements. Tests that were not performed previously and are part of the comparison specification can be added to the results set. The specification comparison capability evaluates results for a single sample across item specifications with the inventory, WIP, customer, and supplier validity rule types.
Can results be leveraged for adjusting lot-specific unit of measure conversions?
Yes. Select the recommended lot UOM conversions based on results for designated tests.
Leverage Test Results to Recommend Item Lot UOM Conversions:
You can use quality test results to measure the variability of a lot attribute across item lots and to propose lot unit of measure conversions. These recommended conversions are sent using OPM Quality UOM Conversion workflow for inventory approval and adjustment.
Following are some requirements that customers have for reports in Quality Management:
Is there a report that identifies inventory that is near expiration?
Yes. Use the Item/Location Required Analysis report to identify inventory that requires retesting and the process quality-enabled items that require evaluation of expiration dating in a selected organization.
Can inventory test results be identified separately from other test results?
Yes. Use the Item/Location Test Results report to display the results obtained from quality samples taken against inventory in a selected organization.
Can supplier or customer sample test results be printed?
Yes. Use the Customer/Supplier Test Results report to display the test results for customer or supplier samples for a selected organization.
Can production sample test results be viewed while material is being processed?
Yes. Use the Production Test Results report to display the test results for production samples for a selected organization.
Does the application offer both Certificate of Analysis and Certificate of Conformance reports?
Yes. Use the Certificate of Analysis/Conformance report to provide verification that the process quality-enabled items produced or shipped comply with test procedures and quality specifications prescribed by the customer.
Can sample storage subinventory and locator be identified?
Yes. Use the Sample Storage Summary inquiry to display the physical storage organization, storage subinventory, and storage locator of a sample taken for quality testing purposes. You can also find a sample storage summary for a specified organization.
Following are some requirements addressed in defining and managing stability testing in Quality Management.
Does the Oracle Process Manufacturing (OPM) stability studies capability adhere to the regulatory recommendations for a written testing program?
Yes. The stability study functionality is designed to assess the stability characteristics of products, and helps you evaluate product storage conditions and expiration dating. By supplying a repository for the collection and processing of this information, OPM stability studies assists in the documentation of a written testing program. Use the Oracle attachments functionality to link written materials to the stability study.
Use the Stability Study Window as a Launch Pad for the Entire Study:
The Stability Study window lets you enter preliminary information about the study including its document number, description, and storage condition plan. Display the status of the study, the master item specification used to evaluate product performance, the laboratory organization conducting the study, and the owner of the study. Display additional information, including the number of variant material sources, storage conditions investigated, and packaging configurations investigated in the study. Once the study is launched, you can monitor all the dates associated to the study. At the completion of the study, the Stability Study window lets you enter recommendations for shelf life and storage specification for the material tested. Use Oracle attachments to link written materials to the stability study.
Can sample size and test intervals be set up to evaluate the statistical criteria for each separate attribute?
Yes. Each of the statistical variables for the stability study can be set up to evaluate the effects of sample size, test interval, and the impact of environmental variables on each individual variant in the stability study.
Create a Test Interval Plan, Storage Condition Plan, and Variants:
The Test Interval Plan window lets you simulate, evaluate, and select test intervals for the study to help you plan for statistical evaluations of study data. Use the Storage Condition Plans window to structure a set of storage conditions to apply to a study. Each storage condition includes a monitoring specification for the environmental chamber and the test interval plan. The application creates a variant for each storage condition, sample material source, and storage package combination. Edit these variants on the Variant window.
Can you retain additional samples?
Yes. Set up the stability study for additional retained samples that are not tested as part of the study, but are retained for historical purposes.
Use Sample Disposition to Indicate Sample Retention:
Use sample disposition to indicate samples to retain in storage prior to stability testing.
Does OPM help identify that reliable, meaningful, and specific test methods were used in the stability study?
Yes. Test reliability is assessed through standard procedures that document test performance. These measures include test sensitivity, test specificity, and test linearity. Set up specifications for each test referencing a test method. By comparing the results of these individual tests to accepted reference tests, you can assess the correlation to these methods as a measure of test accuracy.
Trace Results Back to Test Methods:
OPM Quality Management lets you trace a test result directly to the tester and test method used. The traceability of test method attributes includes the quantity of material required, the instrument used to perform the test, the number of replicates used, the identification of the test kit, the duration of the test, and the decimal precision of the result. Enter realistic test targets and acceptable ranges of test performance that meet or exceed the performance of accepted reference test methods by setting up specifications for each test performed. By incorporating control materials in each test run, monitor test performance. Use control materials to evaluate correlation to reference test method performance as an assessment of test accuracy.
Can several packages be investigated in the same study?
Yes. Set up one or more packages or container closure systems to be investigated in the stability study.
Enter Package Configurations on the Stability Study Window:
Enter the Packages field as the total number of packaging configurations you plan to use to build the study. The default is one package. Study individual package closure systems to compare and contrast product performance in various packaging configurations.
Can an adequate number of batches of each product be tested in a single study to determine an appropriate expiration date?
Yes. Determine the acceptable number of batches to evaluate in the study. Records of all data for expiration dating is maintained in a single referenced study for rapid retrieval and analysis.
Use the Material Source Field to Define Materials to Test:
The required number of source materials is defined on the Stability Study window. Identify the item, lot, and batches that become the basis for the stability study. Source materials can exist in inventory, or can be requested from production for the study.
Can accelerated stability studies be run simultaneously with materials in the recommended storage conditions?
Yes. Set up the recommended storage condition variants in parallel to the accelerated studies. Evaluate basic stability information on the components, products, and container closure systems. Use this information to support tentative expiration dates when the full shelf life studies are not yet available. This indicative information helps you initiate long-term studies such as clinical investigations.
Use Storage Condition Plan and Variants to Deliver Both Standard and Accelerated Stability Testing:
Create a robust storage condition plan that includes both the standard and accelerated environmental storage conditions for materials to test in the stability study. Variants can then be tested in all specified environments simultaneously to deliver both standard and accelerated stability study test results.