Quality Control Groups

Quality Control is a major method of providing process control within Deacom. Quality Control ensures that required Quality Control Tests are performed when Raw Materials are received on Purchase Orders, when Finished Goods are produced on production Jobs, and when previously sold products are returned. Quality Control is an optional feature with a wide array of applications ranging from completely turned off to extremely strict requirements, and is established on an item by item basis. This means that some items can have absolutely no quality control, while others can have many required QC tests.

Quality Control Tests are required to do QC testing. The Quality Control Test describes the base name of the test as well as any applicable testing methods and the Unit of Measure that should be used for testing. Quality Control Groups are a list of sequenced Quality Control Tests for the group to perform. QC Groups can be attached to a Part's Item Master to indicate testing required upon PO receipt or on a Bill of Materials to indicate testing required prior to, or following, finishing of material on a production Job. If two items have identical QC Tests and allowable results, they can share the same QC Group. If two items have different QC Tests or different allowable results, they would each have a different QC Group. A system can have as few as one QC Group, or as many QC Groups as there are items, or anything in between. Items may also have multiple QC Groups assigned based on different testing levels. For example, all Raw Materials may be assigned a basic QC Group, with a certain sub set of Raw Materials being assigned an additional QC Group on the Item Master record to ensure these materials undergo additional QC testing requirements.

Quality Control Security Groups are assigned to each Quality Control Test when the test is added to a Quality Control Group. User Groups are then assigned to QC Security Groups using Quality Control Group Security. This grid must be updated whenever a new Quality Control Security Group or User Group is created to ensure the new group has appropriate access. Specific test protocols and security for entering QC data are configured via Quality Control Groups and security for who can enter QC values is configured via Quality Control Security Groups. Additional system security is required to perform functions such as creating or modifying QC Tests and QC Security Groups.

QC approval process and security options

Quality control results may be entered without requiring approval before users may click the "Finish QC" button and 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.

General QC approval

The ability to require QC approval is determined by the "Approval Type" field on the QC Group. If this field is set to any value other than "None", a separate approval step is required in addition to entry of test results to indicate final approval or rejection of the tested material. In addition, users will be unable to use the "Finish QC" button when performing testing until the "Approve QC" flag has been checked on the Quality Control Results form. Security exists to control access to Approve QC.

E-Signature approval

The "Require E-Signature For Approval" and "Require E-Signature For Results" flags are available to each Quality Control Group. If checked, a valid Deacom username and password is required to be entered before the “Finish QC” step is allowed or before a QC pass may be entered. A record of this approval is stored in Deacom in an encrypted record (AES-256 encryption like the rest of the system). The Deacom application complies with the FDA requirement (21 CFR 11) 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. Note: Multiple e-signatures may be required for each QC pass via the "e-Signatures Counts" fields.

Approving out of spec QC results

A QC result is considered within specification if the result is between the minimum and maximum values defined on the test. The "Must Pass QC To Continue" flag is an optional setting located on each QC item within the QC group. If this flag is checked, the QC result must be between the minimum and maximum values before the material can be accepted into regular inventory. Security exists that allows users to approve QC results when the results are out of specification. This security is used in connection with the Approve QC security mentioned above.

System Navigation

Inventory > Maintenance > Quality Control Groups

Edit Quality Control Group form

Opened via the "New" or "Modify" button on the Quality Control Groups form, the Edit Quality Control Group form is used to group together Quality Control Tests that should be performed on a given Part. Information pertaining to the group is configured using the General and User Fields tabs and all QC Tests belonging to the group are listed on the bottom of the form. A couple notes regarding QC Groups include:

The "un_name" column, which displays the QC Unit of Measure (if populated) is available to this form.
The "Require E-Signature When Saving A QC Group" flag on the System > Options > Inventory tab will prompt and require a user to enter valid credentials before modifying a QC Group.
When modifying an existing QC group, including QC tests on the group, the system checks to see if there are open jobs using this QC Group or if there are lots in Pending QC using this QC Group that have QC values already entered.
- If open jobs are found with the QC Group, the system will prompt users asking if they wish to the update the QC Group on these jobs.
- If there are lots in Pending QC using this QC Group that have existing QC values, then the system will list the affected lots, and prompt users that these lots will have their QC values removed and if they wish to Continue. If users choose to continue, QC values will have to be reentered for the affected lots.

Button	Description
Same As	Allows the user to copy an existing Quality Control Group to use as a base for the one being created. Used Field values, if present, will be copied to the newly created Quality Control Group.
Add	Opens the Edit Quality Control Item form, which is used to add a Quality Control Test to the group and assign values and other qualities.
Modify	Opens the Edit Quality Control Item form, which is used to modify the selected Quality Control Test.
Delete	Deletes the currently selected Quality Control Test.
Sort	Allows the user to sort the order of the Quality Control Tests listed.

General tab

Field/Flag	Description
QC Group Name	Defines the name of the group.
Days Open	Indicates the number of days after production that QC entry is allowed.
Approval Type	Pick list used to indicate when and how approval is required. Options are: All - Approval is required for all tests in the group, regardless if the tests are within range, passed, or failed. Failed - Approval is required only when tests in the group fail the testing parameters. None - Approval is not required for this group. Approval overrides failed tests that are flagged as “Must Pass QC To Continue”. Rejection sends material into Failed QC status, where only approved users have access to it.
E-Sig Approval Type	Pick list used to indicate when and how E-Signatures are required. Introduced in 15.03.072 and replaces the "Require E-Signature For Approval" flag. Options are: All - An E-Signature is required for all tests in the group, regardless if the tests are within range, passed, or failed. Only available when "Approval Type" is set to "All". Failed - An E-Signature is required only when tests in the group fail the testing parameters. Only available when "Approval Type" is set to "All" or "Failed". None - An E-Signature is not required for this group.
QC Approval E-Signature Counts	Only used when approving QC to determine how many e-signatures are required. Option to require, and store, multiple e-signatures when approving QC. If the number in this field is greater than 1, the system will display a signature form, requiring an entry, for the number specified in this field. Only enabled when the E-Sig Approval Type is not set to "None:. Text field with a mask of "9" When the E-Sig Approval Type is set to All or Failed, the value is this field will default to 1. Business Case: - useful for tight quality control processes where an employee and supervisor e-signature is required on QC results. Notes: If multiple e-signatures are required, all must be completed, or no e-signature's will be entered/stored in the system. The enforcement of different credentials per QC Group only is applied when the value in this field is greater than 1. So, for example: If approving quality control results, and there are two QC groups involved, each with an Approval E-Signature Count of "1" in this field, the same approver credentials can be used to sign off on each QC Group.
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.
Active	If checked, this record is active. Only active records may be used in the system.
Default	This flag is not used for Quality Control Groups and therefore has no purpose if checked. It is listed only because it is a standard field on forms.
Complete Empty Tests	If checked, the system will complete empty tests with empty values and move them to QC list/values form. If not checked, the system will only move tests that have values to the QC list/values form. Checking this flag is useful in situations where QC will be performed incrementally on Jobs since users will be able to enter QC via the Close/Relieve form without having to go back to the first pass of QC results and enter values for tests not completed in that pass.
Require E-Signature For Approval	If checked, a valid Deacom username and password is required to be entered before the “Finish QC” step is allowed. Replaced with the "E-Sig Approval Type" pick list. A record of this approval is stored in Deacom in an encrypted record (AES-256 encryption like the rest of the system). The Deacom application complies with the FDA requirement (21 CFR 11) for E-Signatures by employing at least two distinct identification components, namely a username and password as indicated in 21 CFR 11.200. If checked, the "Approval Type" field will automatically be set to "All". If results for a test with this flag checked are entered then modified, the user will be prompted to add a new e-signature for the modified results.
Require E-Signature For Results	If checked, a valid Deacom username and password is required to be entered when applying each pass of QC results. A record of this approval is stored in Deacom in an encrypted record (AES-256 encryption like the rest of the system). The Deacom application complies with the FDA requirement (21 CFR 11) for E-Signatures by employing at least two distinct identification components, namely a username and password as indicated in 21 CFR 11.200. If checked, the "Approval Type" field will automatically be set to "All".
Do QC After Production	If checked, QC is performed after production. Valid only for groups pertaining to produced, not purchased material. Finished material is put into QC Hold status, pending test results.
Approval Required	If checked, approval is required for the QC results to be posted.
Copy Vendor/Pre-Production QC	If checked, and the “Retain QC” field on the Vendor's General tab is set to “Same Part” or “All”, then the system will automatically populate the QC results when receiving the sameUser Lot for items from this Vendor. Useful in situations where companies trust the Vendor's products and QC process. Example: Assume a Vendor has "Retain QC" set to "Same Part" and the QC group has this flag checked. Part 123 is received with a Vendor Lot of "ABC" today and the same item and Lot is also received tomorrow. The user will be prompted to copy QC results when the “Receive” button is clicked on the PO. Once this happens, the Lot goes right into inventory and by-passes QC. The user can still choose a Location in inventory if it is not retained. The security option "Purchasing -- Select lots when copying QC" works with this feature. When set to no, the system will not show the lot selection mover form when copying QC results. This option is useful in situations where customers do not want the employees receiving the product to be making the decision on what QC values to copy. Systematically, if this flag is checked and The QC Group is set on the Item Master, the copy vendor QC functionality will be used. The "Do QC After Production" flag is not checked, and the QC Group is set on the Formula, the copy pre-production QC functionality will be used. The "Do QC After Production" flag is checked, and the QC Group is set on the Formula, QC will not be copied since it is occurring after production. The "Do QC After Production" flag is checked, and the QC Group is set on the Item Master, the copy vendor QC functionality will be used. Additional requirements that are supported by checking or not checking this flag: Check this flag for products when, once QC approves the job (right labels, containers, etc.) the production team can finish as many pallets as needed. Uncheck this flag for products when every single finish/pallet needs its own in-process QC approval before being finished. Another option for QC release of individual pallets is post-production QC.
Fail To Quarantine	If checked, Lots that fail QC testing will automatically be failed to the Quarantine inventory segment. Specifically, functionality has been added on the QC results form to put the Lot into Quarantine if the results are being failed and if any Test in a Group flagged with "Fail To Quarantine" failed. Users with approval can then access Quarantine and determine if the material can be used or scrapped. This feature was added to allow users to produce material via Input Production and have the inventory automatically go to Quarantine. There, a QC Manager may determine if it can be used or needs to be scrapped.

User Fields tab

Deacom allows the creation of user-defined fields that, once created, are available on various master data records such as items, Vendors, and Ship-to Companies. These fields allow companies to enter and store information outside of the fields provided in the system. User fields may be added via Tools > Tools Maintenance > User Fields.

Note: QC Test user fields can be added to the Edit Quality Control form

Work Flow tab

Work Flows, managed via Tools > Maintenance > Work Flows, that are assigned to a QC Group are the associated Sequences that must be completed before it is considered complete. This requires the permission "Quality control -- edit QC Group work flow level 0-9" in Edit User Access to add a Work Flow to a QC Group. A search box with applicable Work Flows allows the user to add the desired Work Flow to the QC Group.

Edit Quality Control Item form

Opened via the "Add" or "Modify" buttons on the Edit Quality Control Group form, the Edit Quality Control Item form is used to manage Quality Control Tests within a Quality Control Group and assign values and other qualities. A few notes regarding the values specified in this form:

The "Min Value" must be less than the "Max Value", unless the max is 0.
Tests may be created with a minimum and no maximum, in which case QC results will pass if the result is greater than the minimum and the maximum is set to 0.
- Example: Assume a test has a minimum of 10 and a maximum of 0. The system will enforce only that the result must be greater or equal to the minimum.
Numbers must be used to accommodate situations where a test result needs to be expressed as "Yes" or "No", "True" or "False", or "Pass" or "Fail".
- In these cases, 0 represents no/false/fail and 1 represents yes/true/pass.
- To enable this option, users may set the minimum and maximum values both to 1.0, in which case 1.0 means yes and any other value means no.
- A "9" may also be added to the "Input Mask" field to ensure only one number is entered for the test result.

Field/Flag	Description
Quality Control Test	Search field used to select a Quality Control Test to add to the group.
QC Test Group	Search field used to select the Quality Control Security Group that applies to this test.
Description	Displays a description of the test, up to 200 characters.
Target Value	Memo field used to indicate the target value for the test. Both numeric and non-numeric test results are allowed. Maximum length is 120 characters.
Default Value	Optional, set the default QC Test value in a QC Test setup which will populate by default. Useful if have many simple/optional QC Tests to lessen the burden of entry.
Min Value	Indicates the minimum accepted value for the test.
Max Value	Indicates the maximum accepted value for the test.
Min Detectable	Indicates the default value for a minimum detectable reading, generally used for legal requirements. Testers can indicate an amount was evident but below the stated detectable level for the test, the testing equipment, or both when entering QC results.
Print Mask	Field used for formatting the QC results on forms. When the Print Mask is not used, the Input Mask will be the fallback field used for formatting the QC Results on forms. Input Mask and Print Mask can be used together when users should enter results with 4 decimals, but only display 3 decimals. Example: If results should always be displayed with 3 decimals, the value in this field should be “9.999”.
Input Mask	Defines the mask, which governs the format, that will be used when entering the results. Example: If results should always be 4 digits long, the value in this field should be "9999".
Aggregate Type	Pick list used to select which QC value, when multiple iterations of a test are performed, will populate on Part Forms. Options are: Average - The average of all values entered for this test will be used. Last - Most commonly used. The last value entered for this test will be used. Max - The highest value entered for this test will be used. Min - The lowest value entered for this test will be used.
Notes	Memo field used to store notes regarding the test.
Required	If checked, a value must be entered for this test prior to moving the item to inventory. This flag indicates that a value must be entered; it does not indicate that the value entered must be a passing value. This means that the validation that all required tests have been completed occurs for pre-production QC at the time of a finish. For post production QC, the validation occurs when the results are finished via Production > QC Result Entry.
Must Pass QC To Continue	If checked, a value entered for this test must be between the minimum and maximum defined. For tests set with a minimum but no maximum, results will pass if the result is greater than the minimum and the maximum is set to 0.
Print On Forms	If checked, the test description, values, and notes will be available for display on Part Forms, including Certificates of Analysis. When checked, the "Required" and "Must Pass QC To Continue" flags will usually also be checked since Certificates of Analysis will primarily display required tests with passing results indicated.
Prints On POs	If checked, the test description, values, and notes will be available for display on Purchase Orders. This allows companies to display/communicate the QC parameters that will be utilized. Even if this flag is checked, the appropriate fields will still need to be added to the appropriate Part Forms and Report Layouts in the system.
Require Notes	If checked, users will be required to enter notes for this test, via the "Edit Notes" button on the Edit QC Results form, before results can be saved/applied. Useful in situations where additional, critical notes, must be entered on a test. The "Result Notes" field on the Modify QC Result form will be displayed in blue when this flag is checked to better alert users when multiple QC Tests are present.