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:

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

  1. Create the Test Template.

    1. Start 'Test Template. Open' (QMS100).

    2. On the B1 panel, enter the required field values:

      • Test name
      • Effective Date/Time
    3. Select the Create option to access the E panel and enter the various field values:

      • 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.
    4. 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.
  2. Create the Set, optionally.

    1. Start 'Set. Open' (QMS150).

    2. On the B1 panel, enter the:

      • Set name
      • Test to be included in the set
    3. Select the Create option to access the E panel that shows a grid with the included quality tests in the Set.

    4. You have the option of including other existing tests in the Set.

  3. Create the Specification.

    1. Start 'Specification. Open' (QMS200).

    2. On the B1 panel, enter the:

      • Specification name
      • Item or Quality group to which the specification will be associated
      • 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.
    3. 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.
      • 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.
      • 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:

        Lot Blending

      • 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.
  4. Create the Specification Test

    1. Start 'Specification Test. Open' (QMS201).

    2. On the B panel, enter the:

      • Item number or Quality group
      • Effective date/time
    3. In the Test field, enter a Test template ID.

    4. Click the Apply button to show all the tests associated with the specification.

    5. Select the Create option to add a test to the grid.

    6. 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
    7. Save your changes.

  5. Create the Specification Entities.

    1. Start 'Specification Entities. Open' (QMS210).

    2. 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)
    3. Click the Apply button to show all the current entities attached.

    4. Enter an Entity ID and select the Auto-attach check box if required. Select the Create option to add the entity to the grid.

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:

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:

QMS200Fnc program

The Specification function program (QMS200Fnc) calls the logic for creating and/or updating a specification.

This function program (QMS200Fnc) includes these operations:

QMS201Fnc function program

The Specification Test function program (QMS201Fnc) calls the logic for setting up specification tests.

This function program (QMS201Fnc) includes these operations:

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:

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:

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.

Note: The QMS702Fnc (auto-approval) program will not update lot status unless the selected value of the QI request origin field is 'Standard QI request'.

The function program includes these operations:

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:

MI transactions

The Test Template includes these QMS100MI transactions:

The Set includes these QMS150MI transactions:

The Specification includes these QMS200MI transactions:

The Specification Entities include these QMS210MI transactions:

The Specification Test includes these QMS201MI transactions:

The Specifications on a QI request include these QMS301MI transactions:

The Test Results include these QMS400MI transactions:

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