Manufacturing support according to 21 CFR Part11 / GAMP5#
In production, the finished product reports are often posted by several employees at centrally installed workstations. In order to clearly identify the person who posts the consumption reports or finished reports, an additional identification of the user is required in the production log sheet (electronic signature) so that the requirements of 21 CFR Part 11 are guaranteed.
Advanced production facility#
In the extended production setup, you can define that the verification of the current user via digital signature is activated / deactivated. To do this, first call up the "Extended production setup" via the user search.
The "Advanced production setup" opens. As soon as you activate the "Check Dig. signature in Prod. book. sheet" check box, the user's check by digital signature is active.
Production user facility#
All users who are allowed to perform bookings in production are set up in the so-called "Production User Setup". To access the production user setup, call it up via the search.
The production user setup card opens on which you can create a new user via "New".
When creating users, there are three options for mapping booking rights:
- Each user has his own login. Then the "Resource no." field can remain empty.
- Each workstation has a fixed user. Only certain persons are allowed to book at each workstation. In this case, all permitted resources are recorded per user ID.
- It does not matter at which workstation the booking is made. In this case, the "User ID" column remains empty. Only the "Resource no." column is recorded.
The other fields are used to manage the digital signature:
|Digital signature||The digital signature of the user is entered here|
|Digital signature locked||Here you can manually block a user from executing the digital signature|
|Digital signature No. Incorrect entries||Displays how many times the user entered the digital signature incorrectly during the last attempt.|
If three incorrect entries are made, the "Digital signature blocked" field is set and the text "Password entered incorrectly 3 times" is stored in the "Digital signature blocking reason" field. Digital signature blocking reason Specification of the reason for blocking Reset digital signature If the field is set, the user must update it before entering the next signature.
Book. production sheet#
When booking the production book. sheet, the digital signature is requested (if activated in the facility).
If several resources are stored for the currently used workstation, the resource number of the user must also be entered in the "Resource no." field.
The digital signature is then entered.
Logging of user ID/resource no.#
The user ID and the resource no. from the digital signature are logged in the item items / capacity items during the posting process and can be displayed.
The overview and map of released production orders have been adjusted so that the status of the production order is visible as a percentage and by traffic light for the following statuses.
- Consumption material
- Consumption capacity
- Confirmation (status of actual confirmation)
In addition, progress values for external work are displayed as follows:
Status external production:
In the field "% Fremd. Fert. Orders", the remaining order quantity (base) from the associated order lines + the quantity (base) from the associated Geb. purchase delivery lines is added for each FA operation (with external production).
Subsequently, the sum of the two fields (as a sum over all FA operations) is divided by the input quantity from the FA operations (also as a sum over all FA operations) and then divided again by 100.
Status external production confirmation
In the field "% Fremd. Confirmations" is added per FA operation (with external production) the finished quantity from the associated capacity items.
Subsequently, the sum of the field (as a sum over all FA operations) is divided by the input quantity from the FA operations (also as a sum over all FA operations) and then divided again by 100.
For the color highlighting of fields on the map of released production orders, the respective fields can be defined via "Style Definition". The style definition causes a different style of the column "Quantity" on the page "Released production orders".
You can find more information about "Style Definitions" in the section of the same name „Style Definitions“.
Comfort navigation for production bill of materials and routings#
This service area gives you direct navigation to the production bill of materials and routing from the parts card. This makes it easier to navigate to the production-related master data.
Likewise, the production BOM for the component, the production BOM stored on the article and the routing are visible. Navigation is also possible here.
In the daily work of production control or work preparation, it is often necessary to branch from an article to another screen such as that of the production BOM or the routing. The aim of the comfort navigation is to reduce this click depth to one step in order to branch quickly and safely to the background information.
In Microsoft Dynamics Business Central™ Standard, for example, 3 calls are required to branch from the article via the production BOM overview to the version overview in the production BOM version.
Insight via Assist call#
The insight is executed via the Assist call. You can find applications for this:
- From the article card to the production BOM, routing with their versions. (Via the Assist button [...] on the respective field (production BOM, routing with their versions)
- From the production BOM line to the production BOM (Via the Assist button [...] on the field Production BOM.
!!!Note "Note In KUMAVISION factory365 the insight via the Assist call has been extended. Further information can be found here.
Creation of production master record via convenient navigation#
If the fields of the production parts list and the routing on the article card are empty, the automatic creation and linking of the production master data with the assembly article can be initialized via the Assist button [...].
To do this, first call up the required article card and click on the Assist button [...] next to the "Finished parts list no." field on the "Procurement" info tab.
A user query appears asking whether you want to set up a new production BOM for the corresponding article. Confirm the query with "Yes" to set up the production BOM.
After confirming the user query, the production BOM editing card opens where you can set up the BOM for the selected article as usual and then certify it.
Release inspection for missing parts#
The "Release check for missing parts" function adds a missing parts list as a form to the production orders. The form shows all FA components that are not available. The form can be called manually (function call via the menu ribbon) or during the release check if missing parts are available.
In order to use the functionality, the appropriate setting must first be made in the production setup.
In the production setup, you can control whether the missing parts table is displayed when the FA status is changed. Depending on the setting, a warning message is displayed which can be accepted.
To do this, call up the "Production setup" via the user search. In the "General" info tab in the "Release check for missing parts" field, you have the following selection options:
|Never||No warning appears.|
|Availability balance||The component availability is checked. This availability is displayed in the overview table.|
|Current stock||The current stock is checked against the production order components and missing components are displayed in a summary table.|
Depending on how the radio button is set up, the results table shows different views:
Column content for the "Current stock" setting#
|Stock (base)||The field shows the current stock of the item (for the selected variant and warehouse)|
|Quantity in FA lines (base)||The field shows the sum of the FA lines. This is the remaining quantity (base)|
|Component quantity in current FA (base)||The field shows the sum of the other FA components. This is the remaining quantity (base) related to the same item, variant and storage location. The due date of the line is also taken into account. If the article in this constellation appears only once as FA component in the production order (= this line), the field thus shows the value 0.|
|Residual quantity (base)||The field shows the remaining quantity (base) of the production order component|
|Inventory by production (base)||The field shows the stock level of the item (same variant code, storage location code) that would result if all FA components and FA lines of the production order were fully confirmed. The following applies:
Stock After Production (Base)
= Stock (Base)
+ Quantity in FA Lines (Base)
- Quantity in FA Components (Base)
- Remaining Quantity (Base).
|Shortage quantity (base)||The field shows the quantity of the item that would be needed at least for the FA component to be completely removed.|
Column content for the "Availability balance" setting#
In this view, the reference quantity is now the item's availability balance, not the item's inventory.
|Availability balance (base)||The "Availability balance (base) results from the stock of the article (same variant code, storage location code) plus all receipts/issues up to the due date of the displayed line. All receipt and issue documents are taken into account, which are also integrated in the availability calculation of the NAV standard (sales, purchase, stock transfer, assembly, etc.).|
|Availability balance After production (base)||The availability balance After production (base) also takes into account the component requirements of the line shown.|
All other columns are understood in an analogous way as in the previous case.
Production structure list#
The data for the production of an article are stored for the corresponding article in the form of routings and a production bill of material in modular form.
You can use the production structure list to display a production BOM in structural representation. The production BOM is exploded across all levels, i.e. if a component of a production BOM has a production BOM again, this is also displayed.
To display a production structure for an item, proceed as follows:
Call up the production structure list via the user search.
Select an article number in the "Article filter" field. Once you have entered the article number, the production BOM number defined for the article is displayed in the "Finished parts list filter" field and the routing number defined for the article is displayed in the "Routing filter" field. In the "Finished BOM version filter" field, the BOM version active on the calculation date is displayed, and in the "Routing version" field, the active version of the routing is displayed. The calculation date is initially preset with the routing.
If you want to display the operations in the production structure in addition to the BOM components, activate the "Display routings" check box.
Then execute the "Calculate" function in the menu ribbon.
All the BOM components and operations of the first level are then displayed in the rows of the window (the "Level" field contains the value 1).
Using the arrow in the "Level" field of the respective line, you can expand and collapse individual branches of the structure. The expanded lines have a larger value in the "Level" field than the initial line.
If you want to expand the complete structure over all levels, you can do it using the double arrow in the "Level" field.
You can view the article card of the initial article of the production structure by clicking on the "Article card" button in the menu ribbon, in the "Associated" menu tab in the "Production structure" area. Furthermore, the "Production BOM" and "Routing" calls are available in the "Production Structure" area.
You can also view the same information for an article in the structure, i.e. in a row, by clicking on the corresponding buttons in the "Row" area.
If you want to view the production structure for a different calculation date than the working date, proceed as follows:
1) In the "Calculation date" field, select the date for which you want to display the production structure. When you enter a date in this field, the application automatically searches for the versions of the production BOM and routing that are active on that date and displays them in the "Production BOM Version Filter" and "Routing Version" fields.
2) Then click the "Calculate" button.
If you want to calculate a specific version of the production BOM that is not the active version on the calculation date, you can change the Finished BOM version filter manually. The calculation date will then only affect the validity of individual components of the BOM, which is controlled by the Start date and End date fields.
You can also display the production structure list for production BOMs that are not assigned to any item, i.e. phantom BOMs. To display a phantom BOM, proceed as follows:
1) Select a production BOM number in the "Production BOM filter" field. The application automatically searches for the BOM version active on the calculation date. If you calculate a phantom BOM without a part number, you will not be able to display routings.
2) Then click the "Calculate" button.
FA Production structure list#
With the help of the "FA Production structure list" you can display a production order in structure view. The FA. Components are exploded over all levels if it is a multi-level production order.
To represent a FA production structure for a production order, proceed as follows:
In the "FA status filter" field, select the status of the production order you want to display. Then, in the "FA No. Filter" field, select the number of the production order you want to display.
If, in addition to the FA components, you also want to display the FA operations in the FA production structure, place a check mark in the "Calculate routings" field.
Then click the "Calculate" button in the ribbon.
The same functions are available in the FA Production Structure List window as in the Production Structure List window.
FA Cancel release#
In Microsoft Dynamics Business Central™ it is not possible to terminate a FA if bookings (consumptions, time messages) have already been made but no actual message (stock receipt) has been made yet.
In order to be able to execute a cancellation of a FA including the status change to Finished, a cancellation function has been implemented in KUMAVISION base (BOOSTER) which also considers the constellation as described above.
The cancellation function requires the following conditions:
In the user setup on the info tab "KUMAVISION" the right "FA cancellation allowed" must be activated for the respective user.
If actual notifications (stock receipts) have already been made, these must be cancelled in advance via the actual notification book. sheet.
If consumption postings have already been canceled, it is checked whether these cancellations were really posted with a concrete compensation to the original consumption. If this was not carried out/posted in this way, a cancellation can no longer be carried out via this function. In this case, the cancellation of the individual movements and the termination of the production order must be carried out manually, as provided by the standard system.
Carrying out cancellation bookings#
Provided that the prerequisites for a cancellation are met, the respective production order is cancelled as follows.
Cancellation takes place per production order line, based on its consumption and capacity postings. The postings are made on the working date.
The remaining quantities of the material consumptions are reversed via an explicit clearing of the respective consumption items. Thus, one reversal posting is carried out per consumption item
The dimension values are transferred from the original consumption item during the reversal posting.
Actual messages (capacities)#
For each routing no. and operation no., the posted actual quantities, scrap quantities, setup times, processing times, downtimes, "direct costs" and overhead costs are added up.
The "Direct costs" are calculated per cancellation booking on the basis of the total times (setup time, processing time, downtime) since the cancellation of setup times, processing times and downtimes is carried out with one booking.
If the finished/semi-finished product of the FA line is not valuated according to standard, the overhead costs (indirect costs %) are posted weighted according to the total overhead costs!
The dimension values are transferred from the original capacity items during the reversal posting.
After the cancellation of the consumptions and actual messages (capacities) per FA line, the production order is transferred to the status "Finished" with the standard functionality.
Here it is to be noted that by the standard functionality of the status change on "Finished" very well still bookings "backwards" can take place. These could be, for example, setup times of operations.