Quality Tests, Sets and Specifications
In the Quality Management System (QMS), the 'Specification' (QMS200) program allows you to define the quality requirements specific to items. Quality tests contain the quality measurements or parameters to determine whether items pass or fail testing. When setting up quality tests, you define the frequency in which a test is performed, the sample sizes that are used, and the acceptable values for testing results.
There also is an option to create Sets that each contain a group of tests associated with items having similar characteristics (for example, a quality set for liquid-related tests). In addition, quality tests are created as a part of a quality specification and can be modified for a specific item to define its exact quality testing targets and ranges. Quality specifications can be defined for an item or a group of items.
The 'Test Template' (QMS100) is a program that allows you to define various default test-related data values to be used when a Spec Test is created. It is a test that serves as a model to copy and change when added to a specification. This functionality allows for consistency across facilities.
QMS also offers the capability to auto-attach specifications based on the setup of Specification Entities for each specification. There are several Entity types available:
- Customer
- Delivery Customer
- Supplier
- Manufacturer
- From Warehouse
- PO receipt warehouse
- Facility
- Country of origin
- To warehouse
When setting up an entity type on 'Specification Entities' (QMS210), you select the actual entities that are to be included in that particular entity type for a specification. As part of this setup, the Auto-attach setting may be applied to any or all of the listed entities, and the specification auto-attach function would occur at the time of a transaction. For example, if you are setting up the Customer entity type, the list of customer organizations will be defined as specification entities. In the case of those entities which have the Auto-attach setting enabled, the specification(s) will be attached automatically for customer-related transactions, such as Customer Orders (CO).
Before you start
The setup conditions outlined in Managing Quality Control must be met.
Follow these steps
Set up Test Template, Set, Specification, Spec Test, and Specification Entities
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Create the Test Template.
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Start 'Test Template. Open' (QMS100).
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On the B1 panel, enter the required field values:
- Test name
- Effective Date/Time
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Select the Create option to access the E panel and enter the various field values:
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Test type - indicates the type of test for which the template will be used. The test type may be:
- Quantitative, meaning the test result is associated with an objective quality of an item that is measurable and verifiable, such as thickness, weight, PH balance, viscosity, etc.
- Numeric qualitative, which applies user-defined values as a means of modeling a certain number of discrete test result values defined by a code. For example, if a numeric qualitative test is assigned a test results code called Color, the test results for that code would be allowed to have several possible values associated with it. In this example, the Color test results code has 4 possible values: 0=white, 1=off-white, 2=yellow and 3=unacceptable.
- Qualitative, which reflects the subjective quality of an item such as feel, taste, appearance, color, etc.
- Inactive date - indicates when the test template will become inactive.
- Required - this setting indicates if the test will be used for the Approval functionality to define it as a test required to pass in order to pass the specification.
- Description - provides a brief summary of the test template's purpose.
- Sampling required - this setting indicates that the test will require samples when executed and when test results are entered.
- Test order - represents the numeric order of a test in a QI request. It is used to identify in which order a test should be executed in the lab to limit sample size and contamination.
- Internal test required - this setting indicates whether an internal test should be conducted.
- Test class - a user-defined code to classify the test based on its nature. For example, a test could be classified as Microbiological, Analytical, Physical, etc.
- Test priority - an informational field to indicate the priority of the test.
- Attribute ID - a unique ID for an attribute used to store values connected to an item.
- Industry standard - a code representing generally accepted requirements followed by the members of an industry.
- Value setup - indicates how the test result values will be defined. If the '0 - Expected value' option is selected, you will enter minimum or maximum expected values on the test template. If the setup option is '1 - Range of values', you must enter a minimum and maximum value range. The value setup option of '2 - Target value only' requires you to enter a Target value.
- Number of decimal places - number of decimal used as precision for the test results.
- Test U/M - the unit of measure in which the test should be measured. The unit of measure also controls accuracy of the test using the decimal precision set.
- Expected value - the value defined in a qualitative type test. Valid values are pre-authorized.
- Target value - the ideal value for the test result.
- External lab limit - The range of values used to record any demands from outside authorities. The value can be used for follow-up statistics and must be entered with the same accuracy as the range value.
- Alarm limit - this value may be used to bring to the attention of the specification manager that the limit violates a security level.
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Test type - indicates the type of test for which the template will be used. The test type may be:
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On the F panel, enter these field values:
- Frequency per - indicates the frequency basis. The test
frequency options include:
- Lot - the number of test sequences per lot
- Units - samples taken from a certain number of units
- Frequency times - the number of samples to be created per each frequency. For example: 4 times every batch, 2 times every 100 eaches, 4 times per lot. This will create the number of test sequences on the QI request.
- Frequency quantity - the size of the sample when the Frequency per value is Units. For example: 2 sequences every 100 eaches. This only applies to a Frequency per field value of Units.
- Frequency U/M - the unit of measure of the frequency quantity. For example, every 10,000 eaches, every 1000 pounds.
- Sample type - user-defined code to classify a sample. For example, liquid, solid, etc.
- Sample size - indicates the size of the sample that will be taken to test.
- Sample U/M - the unit of measure of the sample size that will be taken when testing is performed.
- Measurement method - the technique or approach used to obtain data describing the factors of a process or the quality of the output of the process. Measurement methods must be documented as part of a Six Sigma project or other process improvement initiative, in order to ensure that measurements of improvement to a process are accurate.
- Measurement instrument - this describes what equipment to use for performing an inspection.
- Department - the name of the department. It is given a higher level of priority than a work center. Department is often used as a cost center.
- Laboratory - the internal or external laboratory that will perform the testing.
- Destructive testing - this setting indicates the sample material is broken down in order to be tested.
- Retain sample - this setting indicates whether the sample is to be reserved or stored for further testing.
- Spec approval rule - this setting indicates whether the Spec approval rule is dictated by a setting in 'QI Request Spec Test. Open' (QMS302) or by a setting in 'Quality Plan. Open' (QMS009). If the value is 0, then (QMS009) controls the behavior, if the value is 1, then (QMS302) controls the behavior.
- Spec approval basis - this field indicates options to determine how many test sequence results you must specify to automatically approve 'QI Request Specification. Open' (QMS301) and 'QI Request. Open' (QMS300). If the value is equal to 0, then you must specify the last test sequence. If the value is equal to 1, then you must specify at least one test sequence. The value equal to 2 indicates that you must specify all test sequences.
- Frequency per - indicates the frequency basis. The test
frequency options include:
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Create the Set, optionally.
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Start 'Set. Open' (QMS150).
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On the B1 panel, enter the:
- Set name
- Test to be included in the set
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Select the Create option to access the E panel that shows a grid with the included quality tests in the Set.
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You have the option of including other existing tests in the Set.
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Create the Specification.
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Start 'Specification. Open' (QMS200).
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On the B1 panel, enter the:
- Specification name
- Item or Quality group to which the specification will be associated
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Effective Date/Time
Note: Effective dates and times on a specification are not the same as those on the tests that are attached to it.
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Select the Create option to access the E panel and enter the various field values:
- Status - the specification may be in preliminary, approved, or deactivated status. The preliminary status indicates the specification was created but is not available for use. The approved status means the specification is available to be used in any QI request. Deactivated status indicates the specification is no longer in use.
- Spec Type - indicates which entities the specification is required by (for example, customer, supplier, country of origin, manufacturer, ship to, to warehouse, receiving warehouse and facility).
- Laboratory manager - indicates the person responsible for ensuring that the analysis is performed.
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Set - upon creation of the specification, you may enter a set (i.e. a group of tests) or click F4 to browse for the desired set.
Note: To create a new set, navigate from QMS200 by selecting the Related option 'Spec Test' to populate the Specification Test grid on QMS201. On the B panel of QMS201, select Actions > Select Set which launches 'Set. Open' (QMS150).
After making a selection in the Set field on QMS200/E, the system automatically populates the grid on the 'Specification Test' (QMS201) program, showing the test associated with that set for you to save.
- Auto attach - select this setting in order for the Auto-attach function to be enabled for this specification.
- Retest - if selected, it indicates that the specification is going to be used for retesting purposes only. This is applicable when the stock is in inventory and quality is still monitored. A retest QI request is the document that will be generated manually for the specific item/lot/location/container against which you can record test results.
- Reclassification - indicates the specification is going to be used for reclassification purposes.
- Test at pre-shipment - select this setting if you want to indicate that testing should be performed after the allocation of an item, but prior to its shipment.
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Blending - select this check box if the specification is to be used for a blended lot. For more details on lot blending, refer to the document:
- Retest DO (distribution order) receipt - select this check box if the specification is to be automatically attached to the QI request that is created in the receiving warehouse for a distribution order.
- Grower agreement - select this check box to indicate that the specification is required for the grower agreement.
- Approved by - indicates the person who approved the specification.
- Date approved - when specification was last approved.
- Deactivated by - if applicable, the person who deactivated the specification.
- Deactivated date - when the specification was last deactivated, if applicable.
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Create the Specification Test
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Start 'Specification Test. Open' (QMS201).
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On the B panel, enter the:
- Item number or Quality group
- Effective date/time
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In the Test field, enter a Test template ID.
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Click the Apply button to show all the tests associated with the specification.
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Select the Create option to add a test to the grid.
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On the E panel, indicate the test type and enter any of the fields in the Details section:
- Value setup
- Inactive date/time
- Description of test
- Test class
- Test priority
- Industry standard
- Test order
- Required check box
- Sampling required check box
- Internal test required check box
- Calculated Quality Tests check box
- Formula (only visible and editable if the Calculated by formula check box is enabled)
- Include test in QI request check box
- Print test on COA (Certificate of Analysis) check box
- Print test on specification check box
- Print spec test value check box (to indicate whether the range of spec test values are to be printed on the COA)
- Print result value (to select the option of printing the actual spec test value or only the approved/rejected status of the spec test)
- Copy DO test results (to indicate whether the test results should be copied from the shipping warehouse associated with a distribution order when a QI request is created in the receiving warehouse)
- Test U/M (unit of measure)
- Expected minimum/maximum values and/or Target value
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On the F panel, in addition to other data like the 'Frequency times' and 'Frequency per', specify:
- Spec approval rule - this setting indicates whether the Spec approval rule is dictated by a setting in (QMS302) or by a setting in (QMS009). If the value is 0, then (QMS009) controls the behavior, if the value is 1, then (QMS302) controls the behavior.
- Spec approval basis - this field indicates options to determine how many test sequence results you must specify to automatically approve (QMS301) and (QMS300). If the value is equal to 0, then you must specify the last test sequence. If the value is equal to 1, then you must specify at least one test sequence. The value equal to 2 indicates that you must specify all test sequences.
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Save your changes.
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Create the Specification Entities.
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Start 'Specification Entities. Open' (QMS210).
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On the B1 panel, enter the:
- Specification
- Effective date/time
- Item or Quality group
- Entity type (options are Customer, Delivery customer, Supplier, Manufacturer, From warehouse, PO receipt warehouse, Facility, Country of origin, and To warehouse)
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Click the Apply button to show all the current entities attached.
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Enter an Entity ID and select the Auto-attach check box if required. Select the Create option to add the entity to the grid.
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QMS100Fnc function program
The Test template function program (QMS100Fnc) calls the logic for creating and/or updating a test template.
The Test template function program (QMS100Fnc) includes these operations:
- Add/Copy/Update - this function creates or updates a generic test
template. The information is validated by calling the function
QMS700Fnc.OperationTestValidate. The system displays a warning message to indicate the
existence of any tests with overlapping effectivity dates. If such a condition exists, the
system retrieves the existing test that is overlapping. The effective date range of the
existing test is updated to indicate it has become inactive one minute prior to the
effective date of the new test.
In addition, the system validates that the entered Attribute has the quality controlled setting enabled. It then validates that the Attribute type is numeric if the test is of either the type quantitative or numeric qualitative. If Attribute is alphanumeric, then the test type should be qualitative. The system validates that only one Attribute can be associated with one test. No other test in the system should have a reference to the selected Attribute.
- Delete - this function performs deletion of the test template.
QMS150Fnc program
The Set function program (QMS150Fnc) calls the logic for creating, updating and/or deleting a quality set.
This function program (QMS150Fnc) includes these operations:
- Create/Update - this function populates the Set (QMSSET) table with the set and related tests. Upon creation, the system validates that the Set ID is unique and each test in the set must be unique as well.
- Delete - this function performs deletion of the set from the Set (QMSSET) table.
QMS200Fnc program
The Specification function program (QMS200Fnc) calls the logic for creating and/or updating a specification.
This function program (QMS200Fnc) includes these operations:
- Add/Copy/Update - this function populates the specification data. The
required fields are validated by calling the function QMS700Fnc.OperationSpecValidate. The
system displays a warning message to indicate the existence of any specifications with
overlapping effectivity dates. If such a condition exists, the system retrieves the
existing specification that is overlapping. The effective date range of the existing
specification is updated to indicate it has become inactive one minute prior to the
effective date of the new specification.
For the function to copy a spec, all its test and entities are copied as well. The Approve date, Approved by, Deactivated date and Deactivated by fields should be empty when the spec is copied. The Status field defaults to preliminary.
- Delete - this function performs deletion of the specification which includes deleting all of the specification entities in the Specification Entities (QMSENT) table and all of the tests in the Quality Test (QMSTST) table.
QMS201Fnc function program
The Specification Test function program (QMS201Fnc) calls the logic for setting up specification tests.
This function program (QMS201Fnc) includes these operations:
- Add/Copy/Update - this function populates the specification test data.
The required fields are validated by calling the function QMS700Fnc.OperationTestValidate.
The system displays a warning message to indicate the existence of any specification tests
with overlapping effectivity dates. If such a condition exists, the system retrieves the
existing specification test that is overlapping. The effective date range of the existing
test is updated to indicate it has become inactive one minute prior to the effective date
of the new test.
When updating the test, the system validates that the test effective dates fall within the effective dates of the specification.
The quality controlled attribute associated with the spec test cannot be overridden. The attribute must match the one defined in the test template.
If the test type is Quantitative or Numeric Qualitative, at least one of the expected values must be defined. If the test is Qualitative, you must enter the expected result.
- Delete - this function performs deletion of the specification test.
QMS210Fnc function program
The Specification Entities function program (QMS210Fnc) calls the logic for setting up specification entities.
QMS301Fnc function program
The QI Request Specification function program (QMS301Fnc) calls the logic for adding, updating or deleting a specification. The Changing QI request (QIMD) setting on the Quality plan determines whether or not modifications are allowed to be made on a QI request.
The function program includes these operations:
- Add/Update - this function adds a specification to the QI request or it updates an existing specification in the QI request. After the specification has been added or updated, the system executes the call to the QMS702Fnc program to trigger the auto-approval process.
- Delete - this function deletes a specification from the QI request. After the deletion, the system executes the call to the QMS702Fnc program to trigger the auto-approval process.
QMS302Fnc function program
The QI Request Spec Test function program (QMS302Fnc) calls the logic for adding spec tests to a QI request. The Adding Test to QI request (FIAT) setting on an Item determines whether all tests may be added to a QI request or only internal tests are allowed to be added.
The function program includes these operations:
- Add/Update - this function adds a spec test to the QI request or it updates an existing spec test in the QI request.
- Delete - this function deletes a spec test from the QI request.
QMS400Fnc function program
The Test Results function program (QMS400Fnc) calls the logic for entering, updating or deleting quality test results and test sequences. Any additions, updates or deletions will impact the related quality control lot attributes. It also may trigger auto-approval (QMS702Fnc) when applicable.
The function program includes these operations:
- Update - this function enters test results.
- Copy - this function creates one or multiple test sequences via a copy function.
- Delete - this function deletes a test sequence except for the final test sequence.
QMS700Fnc function program
The Test Validation function program (QMS700Fnc) may be called from the Test template (QMS100Fnc), Specification test (QMS201Fnc) and QI request spec test (QMS302Fnc) where test validations must be implemented.
The Test Validation function program (QMS700Fnc) function program includes these operations:
- Validation of test - this function validates the test data.
- Validation of test dates - this function checks the date and time to detect overlapping test dates in the Test template. The system will issue an error if an existing test overlaps a future test. The new test's Inactive date must be modified, or the original test with the earlier effective date must be deleted manually.
- Validation of specification - this function validates the specification data.
MI transactions
The Test Template Interface includes these QMS100MI transactions:
- AddTstTemplate - adds a test template.
- DltTstTemplate - deletes a test template.
- GetTstTemplate - gets data for a test template.
- LstTstTemplates - lists a test template.
- UpdTstTemplate - updates a test template.
The Set Interface includes these QMS150MI transactions:
- AddSet - adds a new set.
- DltSet - deletes a set.
- GetSet - gets data for a set.
- LstSet - lists a set.
- UpdSet - updates a set.
The Specification Interface includes these QMS200MI transactions:
- AddSpec - adds a specification.
- DltSpec - deletes a specification.
- GetSpec - gets data for a specification.
- LstSpec - lists a specification.
- LstSpecsByItem - lists specifications by item.
- LstSpecsByQMGP - lists specifications by quality groups.
- LstSpecsByRange - lists specifications by item and date or time range.
- LstSpecsBySpec - lists specifications by specification.
- UpdSpec - updates a specification.
The Specification Entities Interface include these QMS210MI transactions:
- AddSpecEntity - adds a specification entity.
- DltSpecEntity - deletes a specification entity.
- GetSpecEntity - gets a specification entity.
- LstSpecEntity - lists a specification entity.
- UpdSpecEntity - updates a specification entity.
The Specification Test includes these QMS201MI transactions:
- AddSpecTest - adds a new test into the Quality Test (QMSTST) table. This transaction calls the QMS201Fnc program.
- UpdSpecTest - updates a test in the Quality Test (QMSTST) table.
- DltSpecTest - deletes a test from the Quality Test (QMSTST) table.
- GetSpecTest - retrieves the details from the Quality Test (QMSTST) table.
- LstSpecTest - lists the tests from the Quality Test (QMSTST) table.
The Specifications on a QI request include these QMS301MI transactions:
- AddSpecToQIReqt - this function adds a specification to the QI request. After the specification has been added, the system executes the call to the QMS702Fnc program to trigger the auto-approval process.
- UpdSpecToQIReqt - this function makes an update to a specification in the QI request. After the update, the system executes the call to the QMS702Fnc program to trigger the auto-approval process.
- DeleteSpecToQIReqt - this function deletes a specification from the QI request. After the deletion, the system executes the call to the QMS702Fnc program to trigger the auto-approval process.
- GetSpecQIReqt - retrieves the details from the QI Request Specification (QMSRQS) table.
- LstSpecQIReqst - lists the specification tests from the QI Request Specification (QMSRQS) table.
The Test Results include these QMS400MI transactions:
- UpdTestResults - this function enters test results and also adds a test sequence if it is provided. If the quality plan is set as auto-approved for the specification, this function will trigger the auto-approval process.
- AddResultSeq - this function creates one or multiple test sequences via a copy function. If the quality plan is set as auto-approved for the specification, this function will trigger the auto-approval process.
- DltTestResults - this function deletes a record from the Test Results (QMSTRE) table. If the quality plan is set as auto-approved for the specification, this function will trigger the auto-approval process for the last existing test sequence.
- GetTestResults - retrieves the details from the Quality Test Results (QMSTRE) table.
- LstTestResults - lists the tests from the Quality Test Results (QMSTRE) table.