Managing Quality Control

This document describes the setup of the Quality Management System (QMS). Every inspection that is performed is reported, and a Quality Inspection (QI) request is created for the lot. This provides the basis for a final assessment of the quality of the lot, which is made when all inspections are reported. The lot is then either approved or rejected.

When a lot is created for an item, which occurs when either a purchase order line or a manufacturing order is received, you can create a QI request on the item’s lot.

A QI request for a lot can be created manually. A QI request can also be created automatically through the QMS800Fnc program for these:

Before you start

Program name and ID

Use

'Qualitative Values. Open' (QMS001)

Selected when creating a Test Template (QMS100), Spec Test (QMS201) or Test Results (QMS400)

'Numeric Qualitative Header. Open' (QMS002)

Selected when creating a Test Template (QMS100), Spec Test (QMS201) or Test Results (QMS400)

'Numeric Qualitative Values. Open' (QMS003)

Selected when creating a Test Template (QMS100), Spec Test (QMS201) or Test Results (QMS400)

'Test Classification. Open' (QMS004)

Selected when creating a Test Template (QMS100) or Spec Test (QMS201)

'Sample Type. Open' (QMS005)

Selected when creating a Test Template (QMS100) or Spec Test (QMS201)

'Industry Standard. Open' (QMS006)

Selected during creation of a Test Template (QMS100) or Spec Test (QMS201)

'Quality Group. Open' (QMS007)

Selected when setting up an Item (MMS001)

'Quality Reason Code. Open' (QMS008)

Selected when creating a QI Request Spec Test (QMS302) or Spec Test (QMS201)

'Quality Plan. Open' (QMS009)

Approval rules defined

'Laboratory. Open' (QMS011)

Selected when creating a Test Template (QMS100) or Spec Test (QMS201)

'Measurement Method. Open' (QMS012)

Selected when creating a Test Template (QMS100) or Spec Test (QMS201)

'Measurement Instrument. Open' (QMS013)

Selected when creating a Test Template (QMS100) or Spec Test (QMS201)

Outcome

The process is completed when the Certificate of Analysis (COA) for the lot is issued.

Follow these steps

To set up the elements of QMS:

  1. Create a quality plan to define the rules for approval.

    The quality plan (QMS009) is used to establish rules for following the quality inspection approval of a particular lot. The qualitative test values (QMS001) and numeric qualitative values (QMS002/QMS003) must be defined as the basis of determining approval.

    The test frequency is defined on the quality plan depending on whether the transaction is related to a Manufacturing Order (MO) or a Purchase Order (PO).
    Note: If the quality plan is no longer active, the test frequency is determined by the order type.
    Quality requests are automatically approved depending on these settings in (QMS009/E):
    • Lot auto-approval through put-away - when this check box is selected, the system is automatically routed to the corresponding put-away program (depending if it is a PO, MO, or CO) for lot approval after the test results are specified. If the check box is not selected, the lot approval must be specified by manually starting the applicable put-away program.
    • Spec auto-approval - when this check box is selected, the quality approval plan for the specification status calculation is executed in QMS.
    • QI request auto-approval - when this check box is selected, the approval plan for the QI request status calculation is executed in QMS.
  2. Update the item master records and attributes to define how to manage quality control.

    These are the quality-related fields on the Item (MMS001/F) and (MMS001/Q):

    • Inspection code - this field indicates if and how the item should be quality inspected:
      • 0 = The item should not be quality inspected.
      • 1 = The item should be quality inspected but without a quality request.
      • 2 = The item should be quality inspected together with a quality request.
      • 3 = The item should be quality inspected together with a quality request and automatically create inspection records in (PPS300) and (MMS235).
    • Quality inspect - this setting indicates whether an item requires quality inspection for non-lot controlled items. When selected, a quality request will be created.
      Note: For manufacturing orders, this field is also applicable for lot-controlled items with Inspection Code set to 0 in (MMS001). A quality request will be created but the balance ID may already be set to status 2 -'Approved' upon receipt. Putaway for quality inspected item in (PMS130) is not needed.
    • Quality group - this field provides a way to classify items that are associated with similar specifications.
    • Inherit specs - this setting applied to packages items and indicates whether quality specifications can be inherited from the related bulk item.
  3. Create test templates to use as the basis to copy and change a test when added to a specification.

    When a test template is created on 'Test Template. Open' (QMS100/E), the corresponding association to an attribute will be established.

    A test template will have versions (with effective and inactive dates) which enable you to plan in advance for changes in test details. These changes can be propagated to existing specifications.

  4. Create sets as a means of placing tests into a group.

    When a set is created on 'Set. Open' (QMS150), the corresponding tests are selected.

    QC sets are used for attaching tests to specifications which are associated with particular items.

  5. Create specifications for item or quality group.

    You perform this activity using 'Specification. Open' (QMS200/E).

    Quality tests that are part of a specification can be modified for a specific item to define its exact quality testing value targets and ranges. The specification can represent the testing for a group of items or an individual item, resulting in the reduction of time required for the setup of specifications for a large number of items.

    Quality tests contain the quality measurements or parameters that determine whether items pass or fail quality testing. Tests also define the frequency in which the test is performed, the sample sizes that are used, and the acceptable values for testing results.

  6. Create lots manually or as a result of transactions.

    Lots may be created manually and require quality control.

    As a result of transactions such as lot blending, lot reclassification, manufacturing release/report receipt, purchased goods receipt and/or customer order (CO) returns, the created lots are subjected to quality control.

  7. Create a QI request.

    Use 'QI Request. Open' (QMS300) to identify a document linked to an item and/or lot and, optionally, the type of order, such as manufacturing order (MO) or purchase order (PO).

    On 'QI Request Specification. Open' (QMS301), you may list the specifications to be auto-attached to the lot. You have the option of selecting a specification and navigating to the E panel to make minor updates, such as changing the Spec manager field.

    On 'QI Request Spec Test. Open' (QMS302/B), the tests are local to the specification on the QI request only. The fields permitted for update are limited to a few, such as the Expected value and Value setup fields.

  8. Specify the test results.

    On 'QI Test Results. Open' (QMS400), you specify the results of a quality test. The values will be selected from previously specified qualitative codes if the test type is qualitative or numeric qualitative.

  9. Process the quality approvals.

    Based on the Spec approval basis and/or Lot approval basis defined in the quality plan, the auto-approval process occurs after test results are specified.

    Lot attributes are updated simultaneously with the manual update of test results of lot-controlled items.

  10. Update the lot balance ID status.

    To update the lot balance ID status (approve or reject the lot), the system employs programs such as 'Purchase Order. Put Away Goods’ (PPS320) for purchasing, 'Quality-inspected Item. Put away' (PMS130) for manufacturing, and 'Balance Identity. Reclassify' (MMS130) for reclassification.

  11. Allocate/pick customer orders and distribution orders.

    For customer orders and distribution orders, the allocation/picking process occurs. After completing the process, a Certificate of Analysis (COA) is issued. A COA can be generated at any point after the QI request is completed.

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