Chemical and Drugs
The packaged enterprise systems offered by Strategic Systems International (SSI) (http://www.ssi-world.com) support such industries as chemical and drugs, and mill-based. The definition of the production process in SSI's flagship product TROPOS can be a close description of the actual way products are manufactured. For background information on SSI, and additional information on TROPOS, see Vendor Defends Its Strongholds With Focused Enterprise Resource Planning Solution.
Part Two of the series Vendor Defends Its Strongholds With Focused Enterprise Resource Planning Solution.
As for chemicals and pharmaceuticals, SSI also shows a deep understanding of their requirements and consequent must-have capabilities, such as potency controls, container movements, top-down and bottom-up traceability (for example, when one needs to trace back from a particular tin of paint to find the test results of a batch material that went into it, or when one needs to identify all the other [completely unrelated] products that were made from a particular tank of crude oil), integrated and automated customs and excise (C&E) controls and documentation, shelf life controls, location validation control, dip tanks with correction controls, and so on. For more information on the chemical industry's exacting requirements, see So What's the Big Deal with Chemicals?.
Like food consumer products, chemicals and drugs are not made of components that can be aggregated into traditional discrete bills of material (BOMs). But on the other hand, these are not generally simple products, as they may be synthesized by way of complex chemical formulae (requiring complex manufacturing processes), or they may be extracted, along with many other by-products, from one major raw material. The TROPOS formulae and process model again comes in handy: process stages can be further broken down to process steps, each with process instructions, quality specifications, and control and test criteria that can integrate with (or even replace) manufacturing execution system (MES) and laboratory inspection management system (LIMS) packages. This allows the user to configure and cost a product according to features and options and user-defined rules without any need to create and maintain part numbers and BOMs for the end product beforehand. The product definition options offer a variety of choices:
- fully defined product codes
- partially defined product codes with quality specifications, grade, or extra data fields
- partially defined product codes with unit of measure (UOM) conversion or secondary dimension controlled by the control reference
- fully configurable products (via a product configurator)
Furthermore, the TROPOS Process Configurator module allows the manufacturing process to be defined according to a similar set of predefined rules, concurrently with configuration of the end product. This module will then calculate the lead time, cost the production process, and add it atop the product costs, while the manufacturing order can be linked directly to the source sales order. The process defined this way can be rate-based if required, with granular time-based traceability for all stages and inputs and outputs.
Recouping huge research and development (R&D) costs is the great challenge for chemical and pharmaceutical companies, owing to a humongous regulatory burden. The environmental regulations require strict monitoring and production restraints, since the manufacture and use of hazardous chemicals requires adherence to strict regulations, especially in North America and the European Union (EU). The chemical industry (and companies that rely on chemicals within their plants) thus have a myriad of new regulations to address.
Restrictions, Requirements, and Other Constraints
The new regulations address the EU's Restriction of Hazardous Substances (RoHS) directive and other regulations that require compositional analysis, development of material safety data sheets (MSDS), environmental analysis, and hazards identification. The chemical industry faces particular scrutiny from a regulatory perspective, since companies have been discussing the impacts of European Classification and Labeling Inspections of Preparations, including Safety Data Sheets (ECLIPS), Registration, Evaluation and Authorization of Chemicals (REACH), Science, Children, Awareness, Legislation and Evaluation (SCALE), and Global Harmonized System for the Classification and Labeling of Chemicals (GHS). For more information, see Process Manufacturing: Industry Specific Requirements; Part Two: Chemical.
Life science and pharmaceutical manufacturers face possibly the toughest restrictions of all, and are required to maintain strict adherence to "good manufacturing practices" as well as to the comprehensive and highly enforced US Food and Drug Administration (FDA) regulations. Implementing and ensuring compliance with employee safety guidelines, possible food contact rules, monitoring emissions (which are often delineated by regulatory permits), and even validating the origin and composition of products are all mission-critical processes that contribute to the cost of doing business. Drugs and chemicals are thus perhaps the most tightly regulated of all manufacturing sectors, and without the ability to satisfy regulators as to the most minute details of production data, companies will be unable to prosper.
For these reasons, chemicals quality control is an integral part of TROPOS, which controls the release of products to customers or for internal use, supporting compliance with regulatory authorities such as the FDA in the US; Hazard Analysis Critical Control Points (HACCP) in Canada; the Medicines and Healthcare products Regulatory Agency (MHRA), Her Majesty's Revenue & Customs (HM C&E), Control of Substances Hazardous to Health Regulations (COSHH), and the Food Standards Agency (FSA) in the UK; Health and Safety Statutory Instruments in Ireland; and European Food Safety Inspection Service (EFSIS)/British Retail Consortium (BRC) standards. (EFSIS is a premier third-party independent inspection and certification service, providing retailers, manufacturers, farmers, and caterers, throughout the world, with expert inspection and certification of their operations to ensure that only the highest standards are maintained.)
Accordingly, the TROPOS Hazards Management module aims at helping users achieve compliance with respect to health and safety, transport, and national inventory regulations throughout the entire business cycle, from receipt of raw materials to dispatch and transportation of finished goods. Each item within TROPOS can have a designated hazard category, which controls how the item must be handled. Hazard and safety information can be defined for each product, detailing the handling instructions, labeling and packaging instructions, and risk and safety phases, and this information can differ depending on the method of transportation.
Additionally, raw materials defined as hazardous cannot be received on-site until the safety information is recorded on the system: all goods receipt notes contain hazard and safety information to ensure safe material handling. Furthermore, all work instructions relating to the use or creation of hazardous materials contain hazard and safety information to ensure safe production and packing activity. Selection of hazardous finished goods automatically checks whether an MSDS needs to accompany the goods, and based on the method of transport, advises which transport documents are required to accompany the goods (in the form of Tremcards), and defines the languages required based upon the transport route defined.
Tremcard is a universally recognized European Chemical Industry Council (CEFIC) system for dangerous goods vehicles that must have emergency information in writing. The information must be set out in a prescribed format, in a language the driver can understand, and in the language of the countries of origin, transit, and destination, so that it meets national and international regulatory requirements and minimizes delays. Last but not least, a national inventory list can be maintained which defines the products that are banned in some countries. The TROPOS Sales Order Processing and TROPOS Purchasing modules automatically check this list and prevent goods being purchased which are not allowed in the home country, and prevent the sale of banned goods to other countries.
Mill products (paper, packaging, textiles, and primary metals) functions are especially strong too, thereby giving SSI strength in these under-served markets. Because it is based on a process model of manufacturing rather than on traditional manufacturing resource planning (MRP II), SSI TROPOS also copes well with by-products, waste products, rework, and scrap. Process yield, work-in-progress (WIP) and roll traceability on a single manufacturing order, job sequencing, and flexible material backflushing capabilities also come in handy to these users, which are almost without exception working in highly competitive markets in which margins are shaved to the bone, and where getting the highest possible yield from materials is crucial to profitability (see The Exacting Needs of Metal Service Centers).
Indeed, dimension-based manufacturers such as paper mills, carpet makers, and steel plants face very different challenges from their brethren in other sectors, since potentially every single product they make may be unique. Like food and chemicals, these environments do not use traditional discrete BOMs or product identity (which are also traditional for discrete engineering companies), given that derivative products must have multiple attributes covering dimensions, length, color, coating, texture, width, grade, thickness, patterns, and specification, all to be defined without creating new product codes. The TROPOS Attributes capability provides a facility for those industries whose ordered products are not discretely definable. It also represents an ideal place to store customer-specific data on the TROPOS database, with the added advantage that it can be flexibly searched. The ability to search by attribute (for example, by dimension) is fundamental, and needs to be fast. Up to thirty attributes can be searched at a time in TROPOS, and numeric ranges (for instance, "less than 1.2 m and greater than 0.6 m"), specific values ("black and gray"), and wild cards can be used to qualify searches.
It's especially true in these industries that standard products and the typical "one product equals one product number" principle do not apply, since here customers prefer to order in an "attribute" of a product group manner (such as a specific dimension, grade, quality, catch-weight, or pack type). If there had to be a distinct product and process code for each potential ordered item, then the item master and process maintenance would be unwieldy, and the resultant planning, ordering, production, costing, inventory management, allocation, delivery, tracking, invoicing, and dispatch processes would be very difficult to manage. Thus, the TROPOS Attributes functionality is specifically designed for industries which sell many derivatives of a standard product: a single product code and process of manufacture per product group or type can be complemented by user-defined attributes. The result is a slicker business process, and a system which is easier to use and maintain. For instance, the allocation of inventory is sensitive to attributes, whereby only lots with matching attribute values will be allocated to orders that specify a required attribute or range of attributes.
User-definable "intelligent" attributes can be set up by applicability for all key data entities and contexts, such as product group, product, customer, customer/product, sales order line, and so on, whereby attributes default according to a defined hierarchy of data entities (such as product or customer/product to sales order line). There can be multiple attributes (up to a thousand) defined for each data entity in TROPOS, and they can be numeric, calculated, selected from a menu, or free text. Furthermore, user-defined calculations can be added to calculate attribute values from other attribute values, or even from customized access to the database for additional data. UOM conversions can also be attribute-based and automatically linked to inventory movements. For example, inventory can be moved in units of a defined attribute, in addition to the default inventory and standard ordering units for the product.
The standard scheduling logic within the conventional TROPOS Production Planning suite caters to constraint-based scheduling. But where multiple constraints, schedule optimization, or a visual representation of the schedule is required, SSI recommends the use of the TROPOS Planners Workbench. The optional module provides a faster, more effective alternative to manual planning boards or traditional block-scheduling procedures. It is a scheduling system capable of more rapid response in complex situations, and is based on Greycon's S-Plan 4 Advanced Planning and Scheduling (APS) tool (see Advanced Planning and Scheduling: A Critical Part of Customer Fulfillment), and can be implemented stand-alone or fully integrated with TROPOS.
When implemented with TROPOS, the module supports complicated scheduling algorithms that provide available-to-promise (ATP) responses at order entry, in addition to supporting the production planning and management processes. The production scheduling optimization component can help schedule production in a manner consistent with business goals, which can carry varied weighting factors (such as customer order satisfaction, minimum labor, maximized plant utilization, minimum downtime, and so on). Key functionality includes a plant optimization capability, including the number of underlying algorithms (for instance, block scheduling, constraint-based scheduling, traditional MRP, load and transportation mode planning, and intelligent semi-finished stock utilization).
A series of particular capabilities have been developed for industries which are manufacturing dimensional products (such as reels, coils, webs, sheets, and the like), where schedules are based on attributes, and where products are managed that appear in a large number of combinations of physical sizes and specifications. The product manages the many-to-many relationships between orders and physical entities, while using the many UOMs that are part of the product at each step of the manufacturing process. Some users have also been using the module's interface options for budget planning, reservations and enquiries, and data collection mechanisms.
In fact, the days when product quality or price alone were the order winners are long gone: nowadays, time is often the real differentiator. Therefore, in addition to the tight integration with the S-Plan 4 APS engine to allow for accurate sequencing of work through the factory (so that customers get their goods when they want them, at the time they have been promised), the TROPOS Integration Toolkit seamlessly connects planning systems to shop floor IT systems and plant equipment (such as process equipment and weigh scales). This way, the users are better able to know what is actually happening on the factory floor at any given time, rather than having to rely on what the planning system surmises ought to be happening (see The Importance of Plant-level Systems).
The real-time data collection from production affects ATP accuracy, scheduling accuracy, WIP tracking, data validation, and process management, and there is also the possibility of collecting more data, such as quality, traceability, and performance statistics. In fact, the aforementioned APS techniques frequently provide the right solution when backed up by time- or rate-based material pull techniques and efficient shop floor data collection (see The Why of Data Collection).