Propagating Specification Data to a Specification and/or Quality Inspection (QI) Request

In the event of a regulatory organization such as the Federal Drug Administration (FDA) updating its rules, a corresponding change to the Test Template (QMSTTP) table may be required. Those data changes in the Test Template should be propagated to, or reflected in, the associated specification tests and ultimately the Setup of Quality Inspection (QI) Requests. Rather than modifying the specification tests and/or QI requests manually, the update capability is handled via the 'Propagate Test Template Data to Spec Test. Open' (QMS110) program and the 'Propagate Specification Data to QI Request. Open' (QMS220) program.

Before you start

The setup conditions outlined in Managing Quality Control must be met.

Follow these steps

Propagate Data to a Specification and/or QI Request

  1. Propagate Test Template Data to a Specification.

    1. Start 'Test Template. Open' (QMS100) and go to the B1 panel.

    2. Enter a Test template.

    3. Enter the effective date/time.

    4. Select Related > 'Propagate Test Template Data to Specification. Open'

      Note: By selecting this related option, the 'Propagate Test Template Data to Specification. Open' (QMS110) program launches. The purpose of this program is to select the specification(s) to which you want the test template changes to take effect.

      OR

    5. Launch 'Propagate Test Template Data to Specification. Open' (QMS110) directly.

    6. On the B panel, select a Test and also the corresponding effective date/time.

    7. Select a Test type.

    8. Enter any of the desired criteria to filter the specifications to be displayed:

      • Show effective specifications
      • Show future-dated specs
      • Show changed spec tests
    9. Click Apply to populate the specification grid.

    10. Highlight the desired specification(s) in the grid and select Related > Confirm.

    11. In the Propagation Date Parameter section, enter the Test template effective date if you want to apply the changes in the Spec Test (QMSTST) table to the same test template with a new set of effective dates.

      Note: The selected effective date range must already exist for that test template.
    12. On the P panel, enter any of these settings to configure the elements of the test template to be copied:

      • Inactive date
      • Expected, External and Alarm values
      • Frequency-related options
      • Print settings (for Certificate of Analysis and other specification reports)
      • Miscellaneous details (for other fields such as Alternate ID, Description, Calculated Test setting, Formula, Internal Test Required settings, Sampling-related fields, etc.)
    13. Click Next to save your changes.

  2. Propagate Specification Data to a QI Request.

    1. Start 'Specification. Open' (QMS200) and go to the B1 panel.

    2. Enter a Specification.

    3. Enter an Item or Quality group to which the specification is associated.

    4. Enter the effective date/time.

    5. Select Related > Propagate Spec Data to QI Request to start 'Propagate Specification Data to QI Request. Open' (QMS220).

      Note: The purpose of this program is to select the QI request(s) to which you want the specification test changes to take effect.

      OR

    6. Open 'Propagate Spec Data to QI Request. Open' (QMS220) directly.

    7. On the B panel, select a Specification.

    8. Enter a Quality group or an Item.

    9. Select the corresponding effective date/time of the specification.

    10. Enter any of the desired criteria to filter the specifications to be displayed:

      • Show pending QI requests
      • Show released QI request(s)
    11. Click Apply to populate the QI request grid.

    12. Highlight the desired specification(s) in the grid and select Related > Confirm.

    13. In the Propagation Date Parameter section, enter the Specification effective date if you want to apply the changes in the QI Request Test (QMSRQT) table to the same specification with a new set of effective dates.

      Note: The selected effective date range must already exist for that specification.
    14. Click Next to save your changes.

QMS110Fnc program

The Propagate Test Template to Specification function program (QMS110Fnc) calls the logic for copying changes from a test template to associated specifications when a new test is attached to a specification or an existing spec test is updated.

QMS220Fnc program

The Propagate Specification to a QI Request function program (QMS220Fnc) calls the logic for copying changes from a specification to a QI request when a new spec is attached or updated.

QMS301Fnc program

The QI Request Specification function program (QMS301Fnc), which has the purpose of adding, updating or deleting a specification, is called from the propagation programs to validate and insert specifications into a QI request.

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