Quality Approval Rules and Process

Outcome

The 'Quality Plan. Open' (QMS009) program defines the approval rules based on the settings of these definable fields:

• Change the QI request - provides options to indicate whether the QI request will allow modifications:
  • Prevent changes - this option allows no modifications.
  • Allow changes when no test results exist - if selected, you can make changes to an existing QI request when there are no test results already recorded against it.
  • Always allow changes - if selected, any change may be made to a QI request.
• Add test to QI request - provides options to indicate whether a test may be added to the QI request:
  • Only internal tests allowed - this option allows only an internal test to be added to the QI request.
  • All tests allowed - if selected, you can add any test, internal or otherwise, to the QI request.
• Test frequency basis for MO - provides options to define how the test frequency will be addressed for manufacturing orders (MO) when creating a QI request per group of test frequencies or a test sequence on a single QI request:
  • Inherit test frequency from order type - this option allows you to identify how the test frequency will be determined based on the order type.
  • Create test sequence - if selected, the test sequence will be created on an existing QI request.
  • Create separate QI request per sequence - a new QI request will be created when a frequency needs to be generated.
• Replace MO QI request - provides these options on how to handle inventory processing when there are multiple MO receipt transactions for the same lot but with different balance identities (example: inventory status):
  • Use the last QI request recorded - this option enables you to override any quality requirements for subsequent receipts of the same item-lot.
  • Manually reclassify the lot - if selected, an existing item-lot is manually reclassified to the default setting of 'Under inspection' to enable the processing of subsequent receipts into the same lot.
  • Use different location - this selection requires that each inventory receipt is processed separately in a different location, until such time that the balance identities of the inventory receipts allow for the lots to be reclassified into the same location.
  Note: For items that are not lot-controlled, a new QI request will be created in every instance.
• Test frequency basis for PO - provides options to define how the test frequency will be addressed for purchase orders (PO) when creating a QI request per group of test frequencies or a test sequence on one single QI request:
  • Inherit test frequency from order type - this option allows you to identify how the test frequency will be determined based on the order type.
  • Create test sequence - if selected, the test sequence will be created on an existing QI request.
  • Create separate QI request per sequence - a new QI request will be created when a frequency needs to be generated.
• Replace PO QI request - provides these options on how to handle inventory processing when there are multiple PO receipt transactions for the same lot but with different balance identities (example: inventory status):
  • Use the last QI request recorded - this option enables you to override any quality requirements for subsequent receipts of the same item-lot.
  • Use different location - this selection requires that each inventory receipt is processed separately in a different location, until such time that the balance identities of the inventory receipts allow for the lots to be reclassified into the same location.
  Note: For items that are not lot-controlled, a new QI request will be created in every instance.
• Spec approval basis - provides options to define what information is used to auto-approve a spec status and QI request status:
  • Last test sequence must be entered - if selected, the specification is submitted for approval when the last sequence on the test has a value.
  • At least 1 test sequence must be entered - if selected, the specification is submitted for approval when at least one sequence on the test has a value.
  • All test sequences must be entered - this option indicates that the specification is submitted for approval when all sequences on the test has a value.
  Note: 

  For 'QI Request Specification. Open' (QMS301) to be approved, the value of 'Spec approval basis' (QPLN) derives either from the 'QI Request Spec Test. Open' (QMS302) or the 'Quality plan. Open' (QMS009). If the 'Spec approval rule' (SARL) for the (QMS302) is set to 0, then the basis value from the (QMS009) is used to evaluate the test results. If the rule is set to 1, then the basis value from (QMS302) is used to evaluate the test results.

  For example, QI Request 12345 created for an item with QI Request Spec ABC-Spec with two quality tests XYZ and PQR. Test XYZ has a 'Spec approval rule' (SARL) equal to 1 and test PQR has a Spec approval rule of 0. To evaluate Spec ABC-Spec, the logic checks the 'Spec approval basis' (QPLN) for test XYZ from (QMS302) and the 'Spec approval basis' (QPLN) for test PQR from (QMS009) for the item.

• Lot approval basis - provides options to define how to auto-approve a balance ID lot status:
  • All specifications passed - this option indicates that all specifications must pass for the lot to pass.
  • At least one spec with required test passed - if selected, at least one of the specifications with a required test must pass for the lot to pass.
  • At least one spec passed - this option indicates that at least one of the specifications must pass for the lot to pass.

Before you start

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

Follow these steps

Create the quality plan

1. Start 'Quality Plan. Open' (QMS009).

2. On the B panel, select the desired Sorting order (1-'Quality plan, Item' or 2-'Item, Quality plan').

3. Specify the Quality plan ID and select Create.

4. On the E panel, update the desired field values, including the fields that define the rules for the QI request:

   • Maximum quantity per QI request and corresponding unit of measure (U/M)
   • Note: The Maximum quantity field applies only to items that are set as container-managed. This setting is specified in the 'Container mgt' field in 'Item. Connect Warehouse' (MMS002/G). In addition, the QI request must be at the lot level.
   • QI request level (lot or location)
   • Change QI request
   • Active setting
   • Add test to QI request
   • QI request auto-approval setting
   • Spec approval basis
   • Specification auto-approval setting
   • QI request approval basis
   • Lot auto-approval - If this check box is selected, the system automatically routes to the corresponding Put-away program (depending if it is a purchase order, manufacturing order, or customer order) for lot approval after specifying the test results.
   • Manual QI req status - 0-'Pending' is the default selection. Another option is to set the QI request status to 1-'Released' whenever a QI request is created manually.
     Note: This field value defaults to the QI request status when the QI request origin is set to 0-'Standard QI request' or 1-'Retest of lot'.
   • Default QI request as test at pre-ship - This setting only applies if a specification will be used on a QI request immediately prior to the shipment of the item.
   • Auto-reinspection of lots setting
   • QI reinspection level - Lot level or Balance ID
   • Reinspection generation basis - Generated at the release time of the previous QI standard/retest request, or generated upon approval, that is, the completion time of the previous standard/retest QI request.
   • Reinspection calculation date - Use the lot manufacturing date or the previous QI request approved date.

5. Click Next to go to the F panel where the rules for specification approval are defined:

   • For each required and/or non-required test, select the Specification Status value (such as 0-'Not tested', 1-'Passed', 2-'On hold', 3-'Failed').

6. Click Next to go to the G panel, and specify these settings for each business area:

   Purchasing Settings

   • Test frequency basis for PO
   • Replace PO QI request

   Manufacturing Settings

   • Test frequency basis for MO
   • Replace MO QI request

   CO Return Settings

   • Create QI request on CO returns - This setting only applies if a QI request needs to be created for a customer order (CO) return.
   • Copy QI request on new lot only - This check box can be selected only if the 'Create QI req' check box is enabled.
     Note: If you select this check box, the QI request is created then copied from the lot created in 'Customer Return. Open Lines' (OIS391) to the lot specified in 'Customer Return. Display Inspect Result' (OIS392). The (OIS392) program is where the lot reclassification and put-away processes for CO return lines occur.

7. Click Next to save your changes.

MI transactions

The Quality Plan includes these MI transactions:

• AddQualityPlan - Creates a new Quality plan in the Quality Plan (QMSQPL) table using the standard function program QMS009Fnc.
• UpdQualityPlan - Sends updates to the settings in the Quality Plan (QMSQPL) table.
• DltQualityPlan - Deletes the entire quality plan from the Quality Plan (QMSQPL) table.
• GetQualityPlan - Retrieves details of the quality plan from the Quality Plan (QMSQPL) table.
• LstQualityPlan - Lists the settings defined in the quality plan in the Quality Plan (QMSQPL) table.