Setup

Advanced quality control parameters

Path: (Quality\Setup) Besides the quality control parameter in the Inventory and warehouse parameters, the feature 'Advanced quality control' contains a set of parameters in a separate form 'Advanced quality control parameters’, that holds 5 fast tabs:

Figure 9: Advanced quality control parameters

Quality Sample Management Parameters

In this form you can define the parameters used when using the Quality samples processes:

Figure 10: Quality sample management parameters

Sites

In the Sites form a parameter must be set that will allow the license plate disposition code for the LP’s before the first sample + after the last sample to be updated- See 5.1.2 for further elaboration:

Test instruments

Path: (Quality\Setup\Quality control) When setting up the quality control functions, it is possible to create test instruments that can be linked to tests. It is optional/not mandatory information.

Lab sections

Path: (Quality\Setup\Quality control) This functionality allows for the creation of laboratory sections that can be connected to calendars. The calendar is used to decide when a quality order can be executed. The Laboratory deadline is the 'cut-off' time of the calendar days used when testing samples.

Test variables and outcomes

Path: (Quality\Setup\Quality control) In situations, where you are performing simple qualitative testing, like a visual inspection, it is possible to create variables that can have different outcomes, which decide whether a test will pass or fail. The test variables are linked to tests (of type Option) in the various test groups. This is a supplement to actual quantitative testing, where the results of specific measurements decide whether a result is a passing or failing value for a test.

Analysis methods

Path: (Quality\Setup\Quality control) Analysis methods provide a place for gathering information such as experimental protocols that can be attached using standard document management or a link to an online description.

Tests

Path: (Quality\Setup\Quality control) The test form is where you describe the different tests that are used for quality control. They cannot be used for actual testing, until they are part of a test group , which controls the use of the tests and their results. A test contains a lot of information that is used as default values on test groups, as well as relations to other tables.

When a test is added to a test group, information of the test will be inherited to the test on the test group, and most of the information will be editable and thereby unique for the test on the test group.

When a quality order is added, based on a test group, information of test in the test group will be inherited to the test on the quality order, and most of the information will be editable and thereby unique for the quality order.

Here is an overview of the fields on the form:

Item sampling

Path: (Quality\Setup\Quality control) Item sampling is a crucial component of quality management systems, used to determine the quantity of an item that needs to be tested during quality inspections. This process plays a pivotal role in quality orders, ensuring that the right amount of inventory is subjected to testing.

Item sampling in the Advanced Quality and Sample Management module is different from the standard quality module, although the same interface is used as a base.

Here are some of the major differences.

In the screenshot below the areas marked with a red box are not used by the Advanced Quality and Sample Management module.

But the “per updated quantity” field marked with yellow plays an important role in creating samples, calculating the right quantity for the Advanced quality order tests and other things. See below.

Key Features:

1. No Inventory Transactions for Sampled Quantities:

• Advanced quality orders do not create inventory transactions for the quantities calculated by item sampling. This means standard inventory dimensions, like Inventory status, are not utilized, and restrictions have been removed for creating advanced quality orders.

1. Destructive Testing Limitations:

• Destructive testing is not possible for quantities calculated by item sampling in advanced quality orders, due to the absence of inventory transactions.

1. No Inventory Blocking:

• These orders are not used to perform inventory blocking – although it is possible. Instead, blocking is managed using disposition codes at batch or license plate (LP) levels.

1. Storage and tracking dimensions

• In standard quality this controls how the system should find and treat items when a quality order is completed. If for instance a quality order fails, the system needs to block all items connected to this quality order. Using these dimensions the system can narrow down and only block the license plates received, but to do so the license plate dimension needs to be enabled.
• In Advanced quality and sample management the dimensions are used to add information to the sample. For the system to identify a license plate registered towards a batch it is needed to toggle the license plate and batch dimensions to yes. Without this the system does not register a sample towards a license plate, which affects the quality work if the test group is set to license plate sequence.

1. No On-Hand Inventory Requirement:

• There is no need for on-hand inventory availability at the dimensions of the quality order. This allows for testing samples of a batch before the main batch is received or moved during testing.

1. Multiple Orders:

• Multiple open advanced quality orders can exist simultaneously for the same batch or sequence of license plates.

1. Item Sampling Setup:

• The system can calculate the sample quantity as a sum of individual sample types, useful when a large sample is divided for various analyses. Attention to unit conversion rounding is advised to ensure accurate sample quantities. See sample types below

"Per Updated Quantity":

The "Per Updated Quantity" field is used to indicate if sampling should occur in response to the reception of goods, which is particularly relevant when receiving items in multiple shipments or batches over time.

When set to "yes," this field ensures that sampling is conducted based on the quantity received during each update or reception. This is useful in scenarios where items are received incrementally rather than in a single shipment.

Usage in Quality and Sample Management (QSM) Module:

In the context of the QSM module, this setting helps register the amount from which the sample should be drawn accurately. It is essential for calculating the correct sample quantity when dealing with advanced quality associations that reference types other than "Quality sample."

If "Per Updated Quantity" is not set, the system may face difficulties in determining the correct sample amount, potentially leading to discrepancies in sampling and testing procedures.

Restrictions:

For advanced quality associations with a reference type "Quality sample," this field should not be set to "yes." Doing so can disrupt the code responsible for creating advanced quality orders, resulting in incorrect numbers of orders or frequencies.

Advanced Quantity Calculation:

‘Advanced quantity calculation’ – Here you can select to sample sqrt(n)+1. This is a sample quantity that has been used in the industry for many years and is generally accepted by the FDA. The setup will only be available for the quantity specification of ‘Percent’. Example: Order qty is 1000 ea. 100 ea. are registered on an LP (item sampling 100% + calculated) an Adv. quality order is created for 11 ea. (√100= 10 + 1 = 11 ea.).

Sample types

Path: (Quality\Setup\Quality control)

In addition to being able to track and handle a sample, the system contains additional functionality to control the use(s) of the sample. It is possible to let the sample be a separate entity or a sum of function-specific sample types that are tracked individually.

The item sample types are used to define which kind of sample, a specified quantity of the sample is (e.g., a bacteriological, a microbiological) and the laboratory section which performs the analysis. The setup uses sample types with a quantity and container in which it is collected and subsequently stored. The form contains a section where you define sample-specific information such as lab section, quantity etc. There is also an activation checkmark, allowing for easy control of the use of a sample type.

If activated, the associated sample types for an item will be created every time a sample for the item is created. The sample types can hold information of the actual storage location of the sample type, and the storage can change according to status of the sample type. The Site and Warehouse used for sample storage is set up as system parameters for the 3 following areas: Archive, Stability and Laboratory. See 4.2.2 for setup parameters.

The process of registration in the lab. and the rest of the sample status updates can be performed for samples as well as for sample types.

Item sample type setup

Path: (Quality\Setup\Quality control)

Item sample types are a setup form accessed from the Released products form. Here you can define the possible types a sample can be divided into, this is useful if a sample is taken and part of it should be used for e.g. microbiological tests and part for bacteriological tests. The individual sample type holds a qty and a unit of measure, these would normally be very different from the inventory unit, so remember to set up unit conversions between these and the inventory unit of the product. When creating a sample that holds a sample type setup, you can choose to use the summarized ‘quantity’ of the types as the sample quantity.

Test groups

Path: (Quality\Setup\Quality control) Test groups are an important part of quality control. Their main purpose is to define the sequence of tests performed with a specific purpose in a quality order and they are sometimes referred to as check lists or test plan. Secondly, they tie all the various groups and settings together and relate the measured test results to the control of the supply chain.

Functions in Test groups (advanced)

Several functions and improvements have been added by CEPHEO Advanced Quality Control for D365FO. This includes a framework for automatic release of batches or license plates, which does NOT depend on the standard failing or passing of a quality order. Instead, this system functions by giving all tests a priority, where priority 1 tests control the release of a whole batch, individual license plates or a sequence of license plates. It is important to be aware that this release can be performed before all tests are finished on the quality order, and it is possible to have a single priority 1 test that passes leading to automatic release of the batch or license plate, followed by the failing of the remaining priority 2-4 tests and therefore the status of the quality order itself. The detail of the automatic release is explained in the next chapter.

There is, however, the possibility of the disposition code to block any automatic updates. This means that after the first update, the disposition code on the batch/license plate will no longer be changed by the automatic functions. This can also be used if something happens to the batch/license plate production that isn’t registered in the ERP system. An example could be that a license plate and its content is damaged in transport or contaminated due to spillage and you have manually allocated a blocking disposition code to it and then you of course do not want an automatic process to un-block it.

Test groups – action pane

Several new functions have been added to the action pane:

• Copy test group – It is now possible to create a test group by copying and modifying a selected existing group. This creates a new and non-approved test group with the name, description and version entered. When copying a test group to a new test group, attached documents will not be copied to the new test group not the approval status.

• New test group version – It is possible to create a new version of a test group and keep a version history to see the change history. When a new version is created, it saves the old version in the Test group history and if the test group is used on 1 or several adv. quality associations, the new version of the test group will be used prospectively:

• Show test group history – It is possible to see content of old versions of the test group.

Test groups – header

The test group form consists of three parts – an action pane with function buttons, a header section that controls the interaction and consequences of the tests, and below there is a line section, where all the tests in a specific group are listed and the specific setup for each test are defined.

The test group header holds the following fields:

Test groups – lines

The overview tab of the lines shows the tests that are linked to a test group and their sequence:

It contains the following fields:

The general tab includes the extra fields:

The test tab contains the extra fields:

The advanced quality control tab is a new tab controlling several new fields:

The 'Project' control tab is a tab containing several new fields. The purpose is to create a project hour forecast records for each test setup in the test group, when creating a quality order using the test group.

The 'Resource requirements' control tab is a tab containing several new fields. The purpose is to allow setup of resources needed to perform the QC of the current test:

Functionality regarding Supplementary tests

On the tab page 'Advanced Quality Control', the field group 'Test failed settings' is available, containing 3 fields, that enable not only adding supplementary tests when a test fails by activating the menu button 'Add supplementary test', but:

Supplementary tests: In this field you can select a test group that can hold one or more tests, that are added to a quality order, if a test fails.

Auto creation of supplementary tests: If this check box is ticked, the test(s) setup via the test group in previous field are automatically added to the current quality order if 1 of 2 criteria are met:

Automatically creation criteria: Holds the option of selecting 1 of 2 criteria for determining if a 'fail' situation has occurred: 1. When a test fails - When test results for the entire quality have been added up and the result is that the test fails OR 2. When a test result fails – If just 1 failing partial result has been entered for current test, it will trigger the supplementary test(s) to be added.

To control that a registration of test result will not update the test line at the first registration of a test result, a parameter field on tab page General 'Manual test result quantity' that will enable you to manually type in the result quantity on a result line. This will stop the automatic calculation of test quantity in the form 'Register test results' where the result quantity is calculated automatically if entering more than 1 result for a test.

NOTE : We recommend that when setting up Supplementary tests, they should hold another set of batch attributes, than the test it was triggered from, as you may want to save both results on the batch and as you cannot have 2 tests on a quality order with the same batch attribute.

Also 'Supplementary tests' should be the same or a lower priority, than the test it was triggered from, i.e., a Priority 1 test can trigger supplementary test of priority 1 or 2, 3… but a priority 2 test shouldn't trigger a supplementary test of priority 1. This is due to the option of a quality order being set up with 'auto-validation of phase' and/or quality order.

Advanced quality associations

Path: (Quality\Setup\Quality control) Under inventory parameters, when you activate quality management, you decide whether the system should look for quality associations during several processes.

Advanced quality associations create the link between a specific process step and a quality-related action. This will trigger the creation of an Advanced quality order with some pre-defined characteristics, according to the test group selected for the Advanced quality association.

Here you can define how to trigger automatic creation of an Advanced quality order, by choosing site, reference type, item sampling and potential item/account/resource requirements for the specific trigger.

You can also choose the timing of the quality order and whether an event should be blocked. When the quality order is created, it uses the sampling, test group and quality order creation parameters specified here.

It is recommended NOT to change/update the reference type on an active association record, but instead to delete the record and create a new one with the wanted reference type.

Quality order creation criteria

If it is not every time an advanced quality association is triggered that a quality order is needed, you can set up different criteria for controlling the wanted sequence for advanced quality order creation. By setting the ‘Use extended creation criteria’ to the value ‘Yes’, the following setup will be available:

The above example illustrates a setup where a purchase registration (warehouse management process) is triggering this quality association if the following conditions is found:

Site=2

Item=QSM1

First time a new batch is received from a purchase order (Registered = status when receiving using warehouse app)

• Next time after 3 receptions on the same Batch Id.

Using Resource as determinator for quality samples to trigger adv. Quality orders

On quality samples you can state where the sample was taken during production by stating a resource:

For the following combinations it is now possible to state a single resource code:

(*): The record must be saved before selecting the resource for resource code ‘Table’ go get a look up for the correct Site.

Remote device setup for batch-level reception with one quality order

When receiving raw materials in ‘Purchase receipts’ or finished items via ‘Reporting as finished’ from productions, it would often be preferred that only one quality order per batch (Reference types 'Purchase order' or 'Production/Route operations' in adv. quality associations) was generated. The standard D365FO Warehouse Management app would create a quality order per reception action, i.e., the registration of one or more LPs. If item arrival was done in the D365FO client via a journal, you would receive multiple LPs in one journal, and this would trigger one quality order/sample. If you, however, were to receive one LP at a time, as is the case when receiving through the Warehouse Management app, a quality order could be triggered for each LP.

To avoid this. the following setup can be used:

1. Select the check box field 'Use extended creation criteria'
2. Select sequence type = Batch (or Product or Batch/product)

Set up the frequency for days or counter and the frequency to as high a number that it would only be triggered once per batch/product/batch-product combination. This would mean that the first LP reception will trigger an advanced quality order, and not until the frequency is met, a second advanced quality order would be triggered:

Event types for reference type ‘Production’

In standard D365FO, the reference type ‘Production’ can only be triggered by the events ‘Report as finished’ and ‘Registration’. That way it is only possible to trigger a quality association for events that are updating inventory transactions for the produced quantity.

In several different industries, there is also a request for being able to trigger a quality association before anything has been produced, for control processes such as documenting line clearance or cleaning. To support this, the Quality and Sample management module has added two new event types to be used for reference type ‘Production’, that are placed earlier in the production flow and do not require any update of the produced quantity. The two new event types are:

Reference type ‘Return order’

In D365FO the RMA system (Return Management) is a subtype of a sales order. Therefore, RMA orders cannot be set up as a quality association in standard D365FO

To support the processes of quality assurance of products being returned from customers, the Quality associations in the Advanced quality control module for the specific reference type ‘Return order’ can be set up.

The setup of quality associations with reference type ‘Return order’, can be setup in the same way as reference type ‘Sales’, but without the possibility to choose any ‘Event type’, it defaults to ‘Registration’.

Reference type ‘Transfer order’

In D365FO the Transfer order can be found under Inventory management and is used to move on hand from one Site/warehouse combination to another via a transit warehouse.

To support the processes of quality assurance of products being received against a transfer order line the Quality Associations in the Advanced quality control module for the specific reference type ‘Transfer order’ can be setup.

The setup of quality associations with reference type ‘Transfer order’, can be setup with the event types ‘Registration’ or ‘Product receipt’.

Approval of advanced quality association

Advanced quality associations are controlled by an approval framework and are not valid before approval has been performed.

When approving the advanced quality association, the test group and tests in the test group must be approved as well. If one or more elements are not approved, the advanced quality association cannot be approved.

When approval has been performed, it is not possible to edit the record, unless the parameters to allow edit for approved quality associations is activated in the parameter settings.

Test master overview

To get an overview of the total test setup for a specific item number, a test master overview form is available. The form can be found from the released product in the quality section.

When opening the test master overview form, all test setup for the product is presented. Also test setup where the product is part of a quality group or in other ways is setup for testing, is shown.

For the selected item, related information for product specific batch attributes, customer specific batch attributes and item sample type can be shown by activating the available fact boxes. From each fact box, a direct link is available for setting up the relevant data.

For each selected advanced quality association, the related setup for the normal test group is shown below.

Advanced quality order

When created, the Advanced quality order inherits information from the Advanced quality association being used. The information on the quality order can be changed manually after creation i.e., change of parameters or adding or removing tests.

The test lines for a quality order, indicates outcome of test results. The following icons are used:

Results registered for the test have led to Pass of the test

Sufficient results for the test have not yet been registered to perform validation of the test

Results registered for the test has led to Fail of the test

The test lines will also indicate if a test result has already been registered, that are not yet ready to be part of the test validation. This could be the case where operators are creating several test results for the same test, and a Backoffice (lab) process is doing the validation of the registered test results.

The indication can be seen in the field ‘Values entered’

The single test will be calculated with information of expected treatment finished time, according to the setup of expected treatment time and the calendar setup for the lab section performing the analyses. If no lab section or no calendar is specified, the base calendar in advanced quality control parameters is used. The calculation is performed when the advanced quality order is created, if expected treatment time is set up for the tests.

Based on expected treatment finished time for the tests, filters (Views) can be set up to show tests where test results have not been entered within the expected timeframe.

Create Advanced quality order

Advanced quality orders can be created, using different processes

Using Advanced quality association

Advanced quality associations can be used to create quality orders by executing one of the events for one or more of the 9 available reference types.

Triggered via a sample being registered in lab

When using Quality samples on adv. quality associations you can have a setup that triggers a quality sample that is manually or auto registered in lab, and if you have another adv. quality association of reference 'Quality sample' that is setup to trigger an adv. quality order every time or more frequently used, by a frequency of less than every time, e.g. you can have a setup where registering a sample in lab should trigger an adv. Quality order to be created every 4th time.

Manual creation

When working with production orders, users sometimes need to create an Advanced quality order for a production before any production output has been done. Therefore, the user does not know anything about LP and location at time of quality order creation.

This combination is not allowed in standard D365FO for products setup to use the reservation principle ‘Batch below’ but is allowed for products setup to use ‘Batch above’ reservation.

Users need to be able to manually create a quality order for productions before any output is done, no matter what reservation principle the product is using.

Therefore, manual creation of an Advanced quality order of reference type Production, Route operation or Purchase, is possible for the following combination of setup:

The batch to be tested, doesn’t have any on-hand yet, Location and LP is therefore unknown.

The item is setup to use Warehouse Management with a reservation hierarchy using batch below or batch above

The test group is setup to control/release on Batch level

At manual creation of an Advanced quality order, controls will be carried out to verify the settings above, when no LP and location are known. If one or more of the settings are not met, creation of the Advanced quality order is not possible.

Advanced quality order form

Path: (Quality\Common\Advanced quality order) A advanced quality order defines a set of one or more tests (via the test group) that must be performed for an item and a test quantity of its related order (such as a Purchase-, Sales, RMA-, Transfer- or Production order..) or a test quantity of its inventory.

Multiple Process Industry fields, menu buttons/-functions have been added to the advanced quality order form:

Transfer test results to batch attributes

Path: (IM\Inquiries\Dimensions\Batches) In standard D365FO it is only possible to have a single open quality order relating to a batch. Therefore, it is also only possible to transfer test results from this quality order to the attributes of that batch.

In the CEPHEO Process Industries solution for D365FO the concept of batches has been extended, as a batch can span over multiple license plates and be manufactured over several days. We have therefore introduced the possibility of having several quality orders relating to the same batch and the ability to choose the relevant test results from these orders to represent the batch attributes. On the batch overview this can be accessed via menu item on tab page 'Test results':

and a form showing the test results related to the batch and batch attributes opens:

If the quality order has been completed (all priority 1 tests have results for the entire adv. quality order quantity), it is then possible to transfer the selected test results to the selected batch attributes. The data is shown in order of quality orders, with the lowest Id at the top.

Values to be transferred can be chosen from any completed quality orders, but only one value for each attribute. When values have been transferred to a Batch attribute, new/other values cannot be transferred to the same attribute.

For transfer of test results, select the wanted values and activate ‘Transfer test result’ in the menu bar.

In the form you can see the quality order phase that indicates whether test results have been entered, the test result icon to the left of it shows whether a result is a passing or failed value according to the limits for the attribute, and warnings will tell you whether a result can't be selected due to incomplete results on an advanced quality order or because results already have been transferred:

transfer test results from all items on batch

When reusing the same Batch Id from bulk product to the finished product, tests and test results are often registered on the bulk product but wanted as results for the finished product. In this case a parameter can control if test results can be transferred from advanced quality orders with an Item/Batch combination to the same Item/Batch combination – or also another Item/same Batch combination.

On the ‘Transfer test results’ tab, we have the ‘Allow all items on batch’ parameter. This is the general decision, to transfer test results to an Item/Batch combination from another item but the same batch.

This is in case the Batch number for bulk items is reused to multiple finished products with the same Batch number, but different item numbers.

Automatic transfer of test results to batch attributes.

Whether you want batch attribute values to be transferred to the batch number of the adv. Quality order to be manually (e.g. if you have multiple test results per adv. quality order line and want to decide which should represent the batch attribute on the current batch) OR if you want a more automated process, it is all possible based on certain parameters.

The following parameters that have an influence on when/if batch attribute values are transferred automatically placed on the test group header :

• Update inventory batch attributes: If set to YES, the field in the field group ‘Automation of transfer’ will be enabled and can be used.
• Skip if value exists: If set to NO (unticked which is default) an existing value on the batch record will be overwritten with the latest value transferred. If set to YES (ticked) an existing value on the batch record will NOT be overwritten in a transfer and will still be the value used on the batch record.
• Only for full set of tests: If set to NO (unticked which is default) batch attribute values cab be transferred even if not all test results are in for the qty on the order(s) that transfers values to the batch attribute values. If set to YES, an automated transfer of batch attributes will only occur when all test results have been entered.

See examples of the use of the settings on the test group header in the next section.

NOTE: The field Skip if value exists is copied to the adv. Quality order LINE.

The settings on the test group lines will determine, which tests will transfer test results to batch attributes. This is done by toggling the “Update inventory batch attributes” parameter on the General tab to yes.

On the test group lines below there are only checkmarks in “Update inventory batch attributes” for the first two test.

Scenarios of automatic transfer, when using the settings on test group header:

Case A : Auto-update of attribute values is not wanted first time all priority one tests have been updated with test results:

• Auto validate priority one lines = Yes
• Auto validate advanced quality order = No
• Skip if value exist = Yes
• Only full set of tests = Yes

Process:

First advanced quality order: Last test result for last priority one test is entered for an advanced quality order àAuto validation of priority one test is performed à Full set of tests is not available à Batch attributes are not updated with values.

Following advanced quality order: Last test result for last priority one test is entered for an advanced quality order à Auto validation of priority one test is performed à Full set of tests is not available à Batch attributes are not updated with values.

Case B : Auto-update of attribute values is wanted first time all priority one tests have been updated with test results:

• Auto validate priority one lines = No
• Auto validate advanced quality order = Yes
• Skip if value exist = Yes
• Only full set of tests = No

Process:

First advanced quality order: Last test result for last test is entered for an advanced quality order à Auto validation of advanced quality order is performed àBatch attributes are updated with values because no values exist for the batch.

Following advanced quality order: Last test result for last test is entered for an advanced quality order à Auto validation of advanced quality order is performed à Batch attributes are not updated with values because values already exist for the batch.

Case C : Auto-update of attribute values is wanted, but only first-time a full set of tests are done released by priority1 tests:

• Auto validate priority one lines = Yes (to be able to release LP on pri1 tests)
• Auto validate advanced quality order = Yes (to be able to update all attributes)
• Skip if value exist = Yes (to keep the first registered attribute value)
• Only full set of tests = Yes (to prevent updating attributes from a reduced set of tests)

Process:

First advanced quality order: Step1: Last test result for last priority1 test is entered for an advanced quality order à Auto validation of priority1 tests is performed à disposition code is updated à Batch attributes are not updated with values because this is not a full set of test results. Step2: Last test result for last test is entered for an advanced quality order àAuto validation of advanced quality order is performed à If full set of tests àBatch attributes are updated with values because no values exist for the batch.

Following advanced quality order: Step1: Last test result for last priority1 test is entered for an advanced quality order à Auto validation of priority1 tests is performed à disposition code is updated à Batch attributes are NOT updated with values because this is not a full set of test results. Step2: Last test result for last test is entered for an advanced quality order à Auto validation of advanced quality order is performed à If full set of tests à Batch attributes are NOT updated with values because values already exist for the batch.

Full set of tests: For a battery of tests in an advanced quality order to be considered as a full set of tests, the tests must be compared to the original set of tests in the test group for the advanced quality order. Only if all tests from the test group can be found on the advanced quality order, the tests can be considered as a full set. Some times there can be more tests on the advanced quality order than in the test group if tests has been added manually or automatically, but all tests from the test group must exist on the advanced quality order to be considered as a full set.

Advanced Quality Order postponement reason codes

In the form ‘Advanced quality order postponement reason codes you can create and maintain reason codes used when entering several days to postpone an Adv. Quality order:

Non-conformance orders

Each manufacturer is required to establish and maintain procedures to control products that don’t conform to specific requirements (21 CFR 820.90). In D365FO/SCM this can be handled via non-conformance orders. These can be created manually and are linked to standard as well as Advanced quality orders. A more automated process has been made, making it possible to auto-create NC order of type ‘Advanced quality order’ when a test/test result fails. This process is linked to the triggering of supplementary tests (see 4.3.12.5) when a test or even just a test result holds a failing value.

The setup is as follows:

1. Set parameter for limiting auto create NC orders to one per item + batch in the Advanced quality control parameters - Default NO: Every time the event that triggers the auto-created NC order occurs; a new NC order is created - YES: Only 1 NC order is created based on the same adv. Quality order.

1. Set the parameters on the test group lines where a failing test/test result should trigger the creation of an internal NC order, the field group ‘Auto-created Non-conformance orders’ is located in the tab page Advanced quality control- Set parameter to YES if you want a NC order to be created automatically, either when a test or a test result fails, and add a problem type linked to the new Non-conformance order type ‘Advanced quality order’ (can be changed on the NC order if needed):