Traceability in manufacturing

EU Food Law EC 178/2002 came into force early in 2002. The regulation covers food for human consumption and feed for food-producing animals.

Article 18 of this regulation will apply from 1 January 2005.

Clause 18.1 states "The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be incorporated into a food or feed shall be established at all stages of production, processing and distribution."

"… operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand."

Reliable controls for formulation management tasks and formulation execution are fundamental to the consistent and profitable production of manufactured goods.

Until recently the pharmaceutical industry, through bodies like the US Food and Drug Administration (USFDA), the Royal Pharmaceutical Society of Great Britain and in South Africa the Medicines Control Council (MCC), was the prime driver behind full lot traceability in manufactured products.

Important organisations outside the pharmaceutical industry are now mandating similar levels of traceability. One of the latest of these initiatives is the European Communities Food Law, Regulation (EC) No. 178/2002.

Major manufacturers in such diverse industries as chemicals, plastic master batching and cosmetics are also adopting the full lot traceability approach for economic and quality management motives.

Most production processes involve creating one or more products in a repeatable manner from a set of components (raw materials). The manufactured items may be semi-manufactured product or finished goods. The components that are used to manufacture a semi-manufactured product or a finished product are typically enumerated in a Bill of Materials (BOM). A BOM for an engine sub-assembly or a complete motor car may consist of thousands of line items. At the other end of the spectrum, a BOM for your favourite muffin mix, or for a tried-and-trusted flu remedy may comprise fewer than twenty components.

Where the components of a Bill of Materials are made up of chemical compounds, powders, granular and liquid elements, as in most pharmaceuticals and foodstuffs, the BOM is often referred to as a Formulation or a Recipe.

Formulation management refers to the disciplined management and control of formulations.

In many smaller manufacturing facilities the master formulations or recipes may be saved as spreadsheet files and there may be little by way of formulation control and versioning of revised formulae.

At the other end of the spectrum large multinationals manage their master formulations in enterprise systems like Syspro, BPCS, JDE and SAP. Control in such systems is more rigorous:

· Access control and user rights may limit who may modify and approve formulation changes.

· Version control may be automated or enforced through business rules.

· Relational tables may ensure that only known components are incorporated in formulations.

Inventory control is another area where there are significant differences between various sizes of business and across industries.

In a small plant there may be little by way of formalised quarantine of received goods (raw materials) prior to QA release of those components for inclusion in production. There may also be no records kept of raw material lot numbers.

In contrast at larger facilities, and in those industries where traceability is mandated, Standard Operating Procedures (SOPs) or business rules incorporated in enterprise systems may enforce:

· Quarantine of received goods.

· Lot number identification and/or labelling of all raw materials at the receiving location.

· Checks for expiry dates.

· Formal raw materials sampling, testing and acceptance or rejection.

· Control of materials movements.

Formulation execution refers to the measuring out of the correct quantities of the correct formulation components.

In high volume production where full traceability is not a requirement and where formulation tolerances are undemanding, the measuring out of the formulation components is often performed by automation systems incorporating Programmable Logic Controllers (PLCs) or dedicated batch controllers.

Automation systems are not suitable:

· Where full traceability is a requirement.

· Where manual weighing is required by law or industry regulation.

· Where the required measurement accuracy cannot be attained in a cost-effective automation solution.

Typical processes where automation systems cannot be applied include weighing formulation components in:

· Pharmaceutical production (manufacturing dispensary operations).

· Many food production processes (pre-weigh areas).

· PVC / Plastics / Rubber Master Batch operations (pigment weighing).

· Paint, Industrial Ink and Dyestuffs pigment weighing.

In such systems Production Orders for batches are typically scheduled automatically when the associated Sales Orders or Production Plans are entered into the enterprise system. These Production Orders may be transmitted electronically to one or more booths in the manufacturing dispensary. There operators confirm the correct lot number of the correct raw material using barcode scanning and then weigh out the correct amount of the component on electronic balances under computer supervision. This ensures that operators do not under- or over-weigh each component. As each weighing is completed, the computer system records full details of the weighing, including:

· Raw material identity (Inventory ID and name)

· Raw material lot parameters (Lot number, SG, Potency, Expiry date, …)

· Operator ID

· Date and time of weighing

· Booth and scale identification

As each component is weighed a bar-coded label may be printed to assist identification during subsequent manufacturing stages.

On completion of a Production Order the detailed information may be transmitted to the enterprise system for inclusion in electronic batch records (EBR) and for back-flushing actual inventory usage by lot number into the enterprise system warehouse.

Full lot traceability

In manufacturing, traceability refers to the ability to trace items. These items may be raw materials, semi-manufactured product or finished goods.

The motivation for full lot traceability is the ability to identify which lot numbers of which raw materials were incorporated in which semi-manufactured and finished production batches.

One of the benefits of full lot traceability relates to product recall. If a problem arises with a particular batch of a finished product the manufacturer is able to identify what quantities of which lot numbers of which components were used to manufacture a particular batch. It also means that if a particular lot number of a component material is identified as suspect, the manufacturer can immediately identify all other batches into which the same component lot was incorporated.

A growing number of South African based multinational corporations are adopting BatchManger from ProLoCon as the software solution of choice to meet their requirements for formulation management and full lot traceability in the regulated and other industries. Users come from such diverse industries as Food, Pharmaceutical, Chemicals, MasterBatch and Welding Electrode Manufacture.

BatchManager is a highly scaleable software solution that can either operate standalone or in conjunction with host systems such as Syspro, BPCS, JDE, ProdStar and SAP.