Companies in process industries usually manufacture products that are subject to varying degrees of regulation by regional, national or global organizations to safeguard workers and/or consumers. For instance DDT is banned in most countries but allowed in some countries or use of asbestos is completely banned but use of benzenes up to 5mg/Kg in toys is allowed in EU.

Process Manufacturing for Microsoft Dynamics® AX 2012 provides a rich toolset for food, drug and chemical manufacturers to manage products containing restricted and / or regulated substances. Process manufacturing solution has been extended further by several ISVs to meet specific requirements of chemical and pharmaceutical manufacturers.

First it is important to familiarize with key terms and definitions as used in Dynamics AX2012

Regulated product

A product is considered to be a regulated product if it is regulated by a government authority and if it requires compliance and audit reporting.

Restricted product

A product is considered to be a restricted product if its distribution is limited or constrained by a government authority.

Reported product

Reported product is a product that is regulated and company is required by regional or national authority to provide usage data on the product.

Product safety data sheet

Product safety data sheet is a brochure that contains handling, emergency and other related information about the product for example, flash point, boiling point etc. of the substance.

Now, follow these steps to setup controls on your products.

Inventory setup

Restriction lists

Restriction lists for countries and regions can be setup in Inventory management module. There are two types of lists – inclusive and exclusive. Inclusive type lists need to be setup for a country before exclusive type list can be setup for its regions.

Figure 1 – maintaining regional lists for restricted products

If number of regions in which product is allowed are more than the number in which it is not allowed, setup an inclusion list for country and an exclusion list for provinces where it is not allowed. If the product and excluded region appear together on a sales order line, system will throw a warning and prevent the sale.

Once the restriction lists are setup, products can be added to such lists. Once products are added to such lists, they are treated by system as restricted products.

Figure 2 – maintaining individual products on a specific restricted products list

Regulated and reported products

Regulated products and reporting lists for countries and regions can be setup in Inventory management module. If the product is only regulated in a country or region then it need not be marked as reported. However if usage data of a product needs to be reported then it needs to exists on a reporting list.

Figure 3 – maintaining regulated products and reporting lists

In the adjoining figure, all products that are regulated in Germany but not reported can be setup against the last record in the table. All other records are for specific reported lists and hence will contain only products that need reporting in specific regions on given reporting lists.

Product safety data sheet

Using this form, default parameters like validity interval and expiry advice interval for product safety data sheets can be setup.

Figure 4 – maintaining defaults for product safety data sheets

   

Setup on Released products list page

Figure 5 – Options available on released products list page to maintain compliance data

Once standard lists are defined in the inventory management module, individual products can be added to such lists from the released products list page.

Regulated products

A (1) regulated or (2) regulated and reported list needs to exist before it can be selected from this option. The user is only able to see the country/ region in the list if a list is already defined. Using this option is faster if a product exists on multiple lists. 

Restricted products

A restricted list needs to exist before it can be selected from this option. The user is only able to select the list ID for a given country/region if a list for that combination is already defined. Using this option is faster if a product exists on multiple lists. 

Safety data sheet

Using this option, user can setup product safety data sheets in various languages and versions. The sheets can be activated as needed. If the records are changed, then a modification reason can be entered and an update log is automatically maintained.

Note: there are several parameters in inventory module that control the display and timing of alerts specific to events that may occur related to product safety data sheets.

Reporting details

Figure 6 – maintaining compliance data as required by a specific regulating authority

Using this form the user can setup additional information as required by some US-centric regulatory authorities. This information can be printed to documents or exposed to external interfaces as maybe needed. If a substance name as defined by a regulatory body is referenced from an external system, then all the product related information attached to such a name can be retrieved. Regulatory authorities covered by this form are as below.

EPCRA: Emergency, Planning and Community Right-To-Know Act

CERCLA: Comprehensive Environmental Response, Compensation, and Liability Act

TSCA: Toxic Substances Control Act

TRI: Toxics release Inventory from United States Environmental Protection Agency

OSHA: Occupational Health and Safety Administration

EHS: Extremely Hazardous Substances

Figure 7 – viewing usage data

Using this form, the user can check the usage data for a particular product. Such information can then either be exposed to custom reports or provided to external systems electronically. CAS numbers (Chemical Abstract Registry) can be linked to the product on this form. 

Using product safety data sheets

Figure 8 – using product safety data sheets

If a product is regulated and if a product safety data sheet already exists then it automatically appears during purchase order or a sales order entry. If a new safety data sheet or a newer version of existing data sheet is received from a vendor then it can be added during purchase order entry. If a new or existing data sheet is to be sent to a customer then that can be added to the log as well. This form keeps a log of all safety data sheets sent or received on each order. Parameters can be setup in inventory management module to control the system behavior regarding safety data sheets at various points in the logistics process.

Figure 9 – setting up product compliance parameters

As shown in adjoining figure, parameters in the inventory management module can be setup to receive warnings and / or e-mail notifications during following processes

Purchase order entry

Sales order entry

Sales packing slip posting

Sales invoice posting

Figure 10 – warning received during purchase order entry

Figure 10 shows one such warning received when a product set to be regulated in Germany is received in a company with German address and if product safety data sheet for such a product is in expiry advice interval.

Figure 11 – parameters control printing and posting on sales packing slip

Figure 11 shows how sales packing slip or invoice posting can be prevented from sales packing slip. It also shows that product safety data sheets attached to the sales order can be optionally printed along with the packing slip posting if setup on parameters in inventory management module.

Hopefully with the help of above setup you will be able to utilize regulatory compliance capabilities in Process Manufacturing for Dynamics AX2012.