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_ISUDMIS_000003 - Define Parameter(s) for Sampling Inspection/Certification

_ISUDMIS_000003 - Define Parameter(s) for Sampling Inspection/Certification

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In this IMG activity, you define the parameters for sampling procedures and certification.

The parameters are used to establish the following settings:

  • Loss of lot membership
If this indicator is set, all devices will lose lot membership upon removal and replacement as long as the field Loss of lot memberhip is selected in the table in Define reasons for installation/removal/replacement. Loss of lot membership occurs if the lot number in the device record is deleted.
  • Loss of certification
If this indicator is set, all devices will lose their certification upon removal and replacement if the field Loss of certification is selected in the table Define reasons for installation/removal/replacement.
  • Loss of certification results in loss of lot membership
If this indicator is set, all devices will lose lot membership after losing certification.
  • Internal inspection
If this indicator is set, an internal certification period longer than the official calibration validity period can be entered in the device category.
  • Lot warehouse
If this indicator is set, you can allocate uninstalled devices to a lot. In addition, in the Determine Lot Devices function, the Include Lot Devices field becomes active. Before warehouse devices can be included in the lot, you must select this indicator.
  • Manipulation of devices despite lot inspection/drawing
If this indicator is set, devices can be allocated to a device or deleted from a lot if the lot has already undergone an inspection or drawing (Swiss requirement).
  • Warehouse devices allowed as sample devices
If this indicactor is set, uninstalled devices can be drawn as sample devices in official lots. This means the Include Warehouse Devices indicator in the Draw lot devices function is active.
  • Certificaton/seal extension control
If this indicator is set, the transaction for certification provides the inspection function in addition to certification.
  • Certification year same as installation year
If this indicator is set, the certification year is automatically set to the inpsection year when devices are installed that are subject to certification, internal certification, and sampling inspection.
  • Repeated use of devices for inspection
If this indicator is set, devices can be used several times for sample inspection (Swiss requirement).
  • Retain lot membership during certification
This means that devices do not lose their lot membership when they are re-certified.
  • Duration of certification overrides lot
This means that devices belonging to a lot that did not pass inspection only have to be replaced when their certification has expired
  • Only certified devices can be allocated to lots

Means that only certified devices can be allocated to a lot.

  • Exclude devices from sample drawing upon installation/removal/replacement
If you select this field, devices are marked as not to be included in sample drawings at the time of installation, removal or replacement.
  • Check the date of the last lead sealing against the current date
If you select this field, you cannot enter a lead sealing date later than than the current date.
  • Replacement period
This parameter specifies the number of years within which the devices belonging to a failed official sample lot must be replaced. As a general rule, failed devices have to be replaced within a year of inspection.

Read the online documentation for each parameter.

  1. Ensure that the SAP settings meet your requirements.
  2. Define the parameters to meet your requirements.






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