Certificate of Analysis

This document explains the purpose of the Certificate of Analysis (COA) which is used exclusively in the Quality Management System (QMS).

Outcome

The Certificate of Analysis (COA) is a report that lists the quality tests and the corresponding results of those tests related to an Item or Item-Lot number.

The COA report is printed from 'Certificate of Analysis. Print' (QMS600). This program may be accessed from the menu of Quality Management System programs.

You have the ability to preview the quality inspection (QI) requests/test results to be included on the COA using 'Certificate of Analysis Preview. Open' (QMS602). On the B panel, you may specify the criteria to filter the QI requests and test results that will be displayed on the COA.

You also have the option of printing a COA from these programs:

The system executes the print function without opening 'Certificate of Analysis. Print' (QMS600).

These are the main parts in a Certificate of Analysis Printout (QMS601PF):

There are additional field values stored in a data file that can be generated in a customized report through the Streamserve solution. For more information on Streamserve, see Define Output Selection based on User.

Before you start

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

The Quality Tests, Sets and Specifications should be created for the testing of an Item. In addition, the required test must have the 'Print test on COA' (PTCA) setting enabled in 'Specification Test' (QMS201) or in 'QI Request Spec Test. Open' (QMS302).

Note: If you disable the PTCA setting in QMS302, the test will not print on the COA for this particular QI request.

Follow these steps

Set up and print the COA

  1. Define the Document Layout for the Certificate of Analysis:

    1. Start 'Document Layout. Open' (QMS650).

    2. Select the Create option.

    3. Specify a Layout Name.

    4. Specify a description of the layout in the Description field.

    5. Select the COA value from the Doc ID drop-down list.

    6. If desired, specify an Entity (i.e. customer name) and the corresponding Entity type.

      Note: If the document layout does not apply to a specific entity, select '0-None defined' for the 'Entity type' field.
    7. Select the 'Set print fields' check box if you want to specify the fields to appear on the COA document.

      Note: You cannot update the fields in the Print Settings section without enabling the 'Set print fields' check box.
    8. Update any of these fields in the Print Settings section:

      • Print order reference information - By selecting this check box, information will be printed for Ship-to customer, Bill of Lading, Order number, Delivery number, and Forwarding agent.
      • Print container ID - When this check box is selected, the Container ID will be printed on the COA.
      • Print lot details - Selecting this check box enables the lot-related information (such as manufacturing date, expiration date, harvested date, as well as approved by, and approved date) to be printed.
      • Print manufacturer information - When selected, the manufacturer-related information (i.e. country of origin, supplier/manufacturer, manufacturer's serial number) will be printed.
      • Print comments - By selecting this check box, any comments specified for each quality test will be included on the printed COA.
      • Print specification test value(s) - This field provides the options as to whether the print setting related to the specification test values should be inherited from the specification test (i.e. option 0), or if this setting should be turned on ('1-Print values') or off ('2-Do not print').
      • Print test category - The selected field option indicates which values that should be printed ('0-Expected', '1-External lab' and '2-Alarm limit'.)
      • Print result value(s) - This field provides the options as to whether the print setting related to the actual test result values should be inherited from the specification test (i.e. option 0), or if the actual results should be printed ('1-Print actual values') or the test result status of approved or rejected should be displayed ('2-Print approved/rejected status').
      • Include rejected tests - By selecting this check box, you will allow any tests with a failed status should be printed on the COA.
    Note: If the print settings are not defined in QMS650, the COA printout will include all standard fields.
  2. Preview a Certificate of Analysis

    1. From the B panel of 'QI Request. Open' (QMS300), select Related > Certificate of Analysis Preview (CTRL+21) to start 'Certificate of Analysis Preview. Open' (QMS602).

      OR

      From the B1 panel of 'Lot/Serial Number. Open/Connect to Item' (MMS235), select Related > Certificate of Analysis Preview (CTRL+47) to start 'Certificate of Analysis Preview. Open' (QMS602).

    2. Specify a Facility.

    3. Specify an Item.

    4. Specify a Lot.

    5. Specify an existing Delivery number in the corresponding field.

    6. Specify a range of QI request dates in the appropriate fields.

    7. Click Apply to see the results in the grid.

    8. Select a row in the grid and click Next.

    9. On the P panel, select the desired criteria to determine which QI request/test result information should be included on the COA preview:

      • Filter test results by hierarchy - if selected, you may preview test results based on hierarchy. The hierarchy is implemented by the system to retrieve QI requests that are used in gathering the associated quality tests and results.
        Note: The first step of the hierarchy is for the system to find any QI request (QRID) that is completed/approved with a '2- Test at pre-shipment' value in the 'QI request origin' (QITY) field. If more than one exists, use the latest QI request. Next, the system adds any unique Test IDs from the QI request with an origin value of '1 -Retest of lot'. Lastly, the system adds any unique Test IDs from the QI request with an origin value of '0 -Standard QI request'.
      • Show pre-ship test if Delivery no not given - this allows you to display the pre-shipment test(s) in the COA preview when there is no Delivery number specified on the B panel of QMS602.
      • Include retest QI request - if selected, the retest QI requests are included in the COA preview.
      • Include standard QI request - this allows you to include the the standard QI requests in the COA preview.
      • Show only the last sequence with results - this check box is selected if you want only the last test sequence that has results to display on the COA preview. If this field is not enabled, all test sequences will be displayed.
        Note: When no results exist for any test sequences, the COA preview will display the first sequence with no results.
    10. Click Next to see the COA preview.

  3. Print a Certificate of Analysis

    1. Start 'Certificate of Analysis. Print' (QMS600).

    2. Specify a Facility.

    3. Specify a Warehouse (optional).

    4. Specify an existing Delivery number (or range) in the corresponding field. If one or more delivery numbers are specified, the test details appear for all associated order lines.

      Note: To reprint the COA for Delivery number(s), the Copy check box must be selected.
    5. If desired, specify an existing Ref Order number (or range) in the appropriate field.

      Additionally, filter by Order Line and Line Suffix (optional).

      Note: To reprint the COA for a Reference Order number, the Copy check box must be selected.
    6. Specify an existing QI request number (or range) in the corresponding field.

      Note: To reprint the COA for a QI request number, the Copy check box must be selected.
    7. Select either an Item or Item-Lot or Item-Lot-Location as a more specific filter (optional).

    8. Specify information in the 'Report text' field (optional).

    9. Click Next.

    10. If the 'Confirm output' field is set to '1' on the 'Output Service Selection. Open' (MNS204), the 'Output. Select Media' (MNS212/B1) program is displayed.

      After you select the Confirm output option, the print job is submitted.

      OR

    11. If the 'Confirm output' field is set to '0' on the 'Output Service Selection. Open' (MNS204), the print job is submitted.

Pre-shipment Testing Logic

Pre-shipment testing refers to any quality testing of items immediately prior to shipment. The system follows a hierarchy for retrieving all QI requests that are used in gathering the associated quality tests:

  1. The system finds any QI request (QRID) that is completed/approved with a '2-Test at pre-shipment' value in the 'QI request origin' (QITY) field. If more than one exists, use the latest QI request.

  2. The system finds any QI request that is completed/approved with an origin value of '1-Retest of lot'. If more than one exists, use the latest.

  3. Lastly, the system finds any QI request that is completed/approved with an origin value of '0-Standard QI request'. If more than one exists, use the latest.

To find all the related Test IDs that will print on the COA (assuming the 'Print test on COA' (PTCA) setting is enabled for the test in (QMS201) or (QMS302):

  1. The system gathers all valid Test IDs from any QI request (QRID) with a '2-Test at pre-shipment' value in the' QI request origin' (QITY) field.

    Note: For the associated test properties, the system looks for the Test IDs and related data in the Custom Test (QMSOTS) table. It then searches for unique Test IDs and its related information in the QI Request Test (QMSRQT) table.
  2. The system adds any unique Test IDs from the QI request with an origin value of '1-Retest of lot'.

    Note: For the associated test properties, the system looks for Test IDs and related data in the Custom Test (QMSOTS) table. Then it searches for unique Test IDs/data in the QI Request Test (QMSRQT) table.
  3. Lastly, the system adds any unique Test IDs from the QI request with an origin value of '0-Standard QI request'.

    Note: For the associated test properties, the system looks for Test IDs and related data in the Custom Test (QMSOTS) table. Then it searches for unique Test IDs/data in the QI Request Test (QMSRQT) table.

The system retrieves test results for each Test ID, based on these conditions:

  1. The system looks for Test Result values for Test IDs and related data associated with a QI request with a '2-Test at pre-shipment' value in the 'QI request origin' (QITY) field.

    If values are found, the system sends those test results. If no results are found, the system looks to see if the same Test ID exists for a QI request with an origin value of '1-Retest of lot'.

    If a matching Test ID exists with results, those values are sent. If not, the system looks for a matching Test ID for a QI request with an origin value of '0-Standard QI request'.

    If there are no test results, no value is printed.

  2. The system looks for test result values for unique Test IDs/data associated with a QI Request (QRID) having an origin value of '1-Retest of lot'.

    If values are found, the system sends those test results. If no results are found, the system looks to see if the same Test ID exists for a QI request with an origin value of '0-Standard QI request'.

    If a matching Test ID exists with results, those values are sent. If there are no test results, no value is printed.

  3. Lastly, the system looks for Test Result values for unique Test IDs and related data associated with a QI request having an origin value of '0-Standard QI request'.

    If values are found, the system sends those test results. If no Test Results are found, no value is printed.

The system retrieves data for Actual Result, Expected Operator, and Tested Date based on these conditions:

  1. The system looks for these values for Test IDs associated with a QI request with a '2-Test at pre-shipment' value in the 'QI request origin' (QITY) field.

    If values are found, the system sends those data values. If no results are found, the system looks to see if the same Test ID exists for a QI request with an origin value of '1-Retest of lot'.

    If a matching Test ID exists with results, those values are sent. If not, the system looks for a matching Test ID for a QI request with an origin value of '0 -Standard QI request'.

    If there are no data values, no value is printed.

  2. The system looks for these values for unique Test IDs and related data associated to a QI Request (QRID) with an origin value of '1-Retest of lot'.

    If data values are found, the system sends them. If no data values are found, the system looks to see if the same Test ID/data exists for a QI request with an origin value of '0-Standard QI request'.

    If a matching Test ID exists, those values are sent. If there are no data values, no value is printed.

  3. Lastly, the system looks for these data values for unique Test IDs and related data associated with a QI request with an origin value of '0-Standard QI request'.

    If data values are found, the system sends them. If nothing is found, no value is printed.

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