Approving QC Results

Companies have the option to determine if QC results must be approved. If approval is not required, users may enter then finish QC results to place items into regular inventory or failed QC inventory. The QC approval process involves the ability to review and indicate final approval for those QC Groups that require this check and also the ability to approve individual QC results that are out of spec for manufactured items. Several different security options and features are available to ensure QC results are validated.

Configuration

The following master data and settings need to be considered prior to approving QC results in DEACOM. Note that QC results must be entered before they can be approved. The process and configuration required for entering QC results is discussed via the Entering Purchasing and Stability QC Test Results and Entering Production and Stability QC Test Results pages. The list below is specific to enabling QC approval. Companies must decide which type and level of approvals will be required.

  • "Approval Type" field - Available on the Quality Control Group level, each Group may be set to either require approval for all QC Tests within the Group, only those Tests that fail, or none of the Tests.
  • "Require E-Signature For Results" flag - Available on Quality Control Groups, if this flag is checked, a valid DEACOM username and password is required to be entered before the “Finish QC” step is allowed. A record of this approval is stored in DEACOM in an AES-256 encrypted record. The DEACOM application complies with the FDA requirement for E-Signatures by employing at least two distinct identification components, namely a username and password as indicated in Section 11-200 of the Code of Federal Regulations.
    • "QC Results E-signature Counts" - Used to determine how many e-signatures are needed to enter results. Enabled only when 'Require E-Signature For Results' is true.
    • "QC Approval E-Signature Counts" - Only used when approving QC to determine how many e-signatures are required.
  • "Must Pass QC To Continue" flag - Available on the Edit Quality Control Item form when managing Quality Control Groups, if this flag is checked, a value entered for the selected Quality Control Test must be between the minimum and maximum values defined for the user to approve results.
  • Security settings - The following security settings will need to be considered for QC approval.
    • "Jobs -- approve out-of-spec QC" - Permission to approve QC results when test results are out of specification, on tests that are marked as "must pass", in Production QC testing. If QC Approval is allowed to override failed tests, give this permission to the appropriate personnel. If QC Approval is not allowed to override failed tests, do not give this permission to any personnel.
    • "Jobs -- approve QC" - Permission to approve quality control results, either for production or purchased material.
    • "Purchasing -- approve out-of-spec QC" - Permission to approve QC results when test results are out of specification, on tests that are marked as "must pass", in Purchasing QC testing. If QC Approval is allowed to override failed tests, give this permission to the appropriate personnel. If QC Approval is not allowed to override failed tests, do not give this permission to any personnel.
    • "Quality control -- approve QC with e-signature" - Permission to approve QC results, if the QC Group requires separate approval.
    • "Quality control -- approve QC with no entered results" - Allow approving qc without any results. Required tests are still required.

Process

Approving QC results and submitting e-signatures

If any type of approval is required by the QC Group, users may check the "Approve QC" on the Quality Control Results form after all test results have been entered.

  • To access this form for purchasing QC, navigate to Purchasing > QC Result Entry and click "Continue", select the appropriate Purchase Order, then click "Continue".
  • To access this form for during production QC, navigate to Production > Job Reporting and click "View", select the appropriate Job, then Click "QC Values".
  • To access this form for post-production QC, navigate to Production > QC Result Entry and click "Continue", select the appropriate Job, then click "Continue".

If an e-signature is also required by the QC Group for approval, a valid DEACOM username and password will be requested. These credentials will be requested again in the event any existing QC results are modified after they were already approved and e-signed. Once the "Approve QC" flag is checked and an e-signature entered, if required, QC results may be finished using the "Finish QC" button on the Quality Control Results form. Keep in mind, results must also be within the test's defined minimums and maximums if the "Must Pass QC To Continue" flag is checked on the QC Group items before results may be approved and finished - that is, unless the user has appropriate security to override this flag.

Performing multiple QC testing passes and adding additional QC Tests

Multiple QC results may be entered as necessary provided the QC Test(s) have not been flagged as "Complete" on the Quality Control Results form and the QC process has not been finished by clicking the "Finish QC" button. If users have entered QC results and wish to allow for multiple testing passes, they can click the "Exit" button on the Quality Control Results form. Any previously entered results will be saved and users may click the "QC Values" button on the Close/Relieve Job form, the Job Entry form, or on various Job reports to enter additional QC testing passes. If multiple results or passes are entered for a QC test, the system will create a new line on the Quality Control Results form and indicate the appropriate pass in the "Pass" column. There are no limits to the number of passed that may be entered.

Additionally, supplementary QC Tests may be added to a Lot, even if those tests are not part of the assigned QC Group. This gives users with the appropriate access the ability to add more results that can be included on the C of A or other print outs, or just kept for informational and reporting purposes.

Automatically inherit and approve QC results for blended lots

Deacom Version 16.07.000 includes the option to gather previously entered QC values for inventory lots relived during production and transfer, and marked as approved, those QC values to produced lots that contain the same QC Test or QC Groups. This optional feature was designed for blended lot scenarios where a lot produced on a job uses/relives multiple lots of the same material that is produced on the job. The feature requires some setup steps prior to use. These steps as well as the steps used in a typical production scenario are listed below.

The following configuration options are recommended when using this feature:

In Inventory > Options > QC tab

  • The "Post QC Location" field should be set to "Current".
  • The "QC Freq Lot Type" field should be set to "System Lot"
  • The "QC Pend Move Revision" field should be set to "Current"

Steps:

  1. Navigate to Inventory > Maintenance > Quality Control Tests.
  2. Click the "New" button to display the "Edit Quality Control Test" form.
  3. Enter a name in the "Name" field. Make a selection in the "Combine Results" field. All other fields on the form are optional. See the "Edit Quality Control Tests" form encyclopedia section for more information on all these fields.
  4. Once all the information is complete, click the "Save" and "Exit" button to complete the process.
  5. Input Production will need to occur in DEACOM and the items that are finished sent to "Pending QC". This is accomplished by adding Quality Control Groups to the items Bills of Material.
  6. Next, QC results are entered in the system.
  7. Finally, a job is created that will produce the final blended lot and if the QC Tests that are marked with "Combine Results" match the QC Tests and QC Groups on the item being produced/finished, the system will automatically insert, and approve, the QC values from the items being relived into the QC results for the lots being finished.

Un-approving QC results

The option to un-approve QC results is only available when performing before production QC in situations where material has not been finished and the production Job has not been closed. This option exists with the assumption that QC results may be un-approved since no material has been placed into inventory on open Jobs where materials have not been finished. In general, this option should be used sparingly and soon after the initial approval process has occurred. The process for un-approving QC results is as follows:

  1. Navigate to Production > Job Reporting.
  2. Enter filters as desired then click the “View” button.
  3. Select the appropriate Job and click the “Close/Relieve” button.
  4. Click the “QC Values” button to display the Quality Control Results form.
  5. Check the “Un-Approve QC” flag and click the “Finish QC” button.

At this point, the QC results will be un-approved but the values entered for the tests will remain on the Quality Control Results form. Users may modify the test values or make other modifications as necessary and either click the “Exit” button if modified results will not yet be approved or the “Approve QC” and “Finish QC” buttons to complete the QC entry process.

FAQs & Diagnostic Tips

TIP: Failed QC Approval Requirements

The system checks the "Aggregate Type" field when determining if Quality Control Groups requiring approval for failed results have passed or failed. Example: Assume a QC Group is set with an Approval Type of "Failed" and all tests in the group have an Aggregate Type of "Last." If multiple QC passes are made, and the last pass for all tests pass, the system will apply all QC test results without requiring approval.