The need for manufacturers to focus on compliance and traceability initiatives is increasing significantly across the globe as commercial pressures grow to meet regulatory mandates. By mitigating the risk of product recalls, reducing manufacturing costs and quality controlling end-to-end traceability of processes, organisations will also be able to successfully reduce inefficiencies within the supply chain.
As defined by National Institute of Standards and Technology (USA), "Traceability of measurement requires the establishment of an unbroken chain of comparisons to stated references each with a stated uncertainty."
Technology can be used to track system status (status tracing), analyse system performance (performance tracing) and support decision making (goal tracing). Software systems, for example, are designed to support the levels of strategy, planning, design and operations. There is a need for all of these forms of traceability in manufacturing to provide a structured, holistic way of managing operations efficiently to meet commercial targets.
In principle, traceability takes two forms. The first, known as product tracking, is the capability to follow the path of a specified unit of a product through the supply chain as it moves between organisations. Products are routinely tracked for obsolescence, inventory management and logistical purposes. The second, product tracing, is the capability to identify the origin of a particular unit and/or batch of product located within the supply chain by reference to records held upstream in the supply chain. Products are traced for purposes, such as product recall and investigating complaints.
One of the key objectives of traceability is to provide visibility across the supply chain. In a recent survey carried out by analyst AMR (Gartner) Research into the expected business benefits of traceability, 41% of respondents, cited “achieve greater inventory visibility” as being the most important business benefit. In order to best achieve this objective, events can be captured at various points in the chain, stored in a secure traceability network and then shared with trading partners.
Why traceability matters
Traceability is a critical requirement across the process industries for several reasons. The first is the need to comply with regulation. From January 2005 onwards, following the issue of EU Regulation 178/2002 -Article 3, traceability has been a legal obligation in the European food sector. All food and feed business operators must have systems in place to identify from whom they have received a food or feed item and to whom they have sold such an item.
Another vital factor is the need for companies across the process industries to use traceability to better manage customer relationships. By using it to reduce the time required to react to customer complaints, for example, organisations can typically ensure higher levels of customer satisfaction.
Traceability enables organisations to “guarantee” the origin of a product or raw material. As such, it also allows them to reduce the risks they face where an incident has occurred by more quickly searching impacted products and removing from the marketplace as and when required.
Traceability also helps organisations enhance the quality of the process and, as a direct result, the quality of the service or solution they are developing.
In many organisations today, process improvement opportunities are being lost because genealogical data is so hard to attain. In this context, traceability helps organisations improve the efficiency and pertinence of quality controls, while at the same time reducing costs by decreasing non-conformities (deviations from specifications, standards or expectations).
Scoping out the challenge
Today, many organisations across the process industries, particularly those in the batch industries like consumer products, specialty and fine chemicals and pharmaceuticals, are still using manual approaches to traceability. While some automated point solutions exist, most users find traceability data by searching through old paper-based records in filing cabinets, log books and spreadsheets.
Even in those organisations where some of the process is automated, a considerable amount of manual intervention typically still takes place. This presents a variety of problems to process industry companies. Organisations often need to keep a history of transactions, typically stretching back as many as ten years to comply with regulations and this necessarily entails retaining a significant amount of paper.
Most of these businesses keep a paper-based standard operating procedure document and mark up comments on it. There are many disadvantages to this approach. First, it is extremely expensive. Second, it introduces errors into the system both in the process and in the documents used to support it. Third, it brings little value to the organisation. It is mainly used for compliance purposes. Unlike data that is collected and stored electronically, it cannot easily be used to support continuous process improvement, carry out ‘what if’ analysis and drive product efficiencies.
While some organisations are now looking to digitise the process, the sheer weight of paper that will need to be moved before this can happen makes this a challenging task indeed. This is why it important that data is not only analysed electronically, but also collected in the same way.
A myriad of uses
Today, to help achieve these goals, automated traceability techniques are used across a broad range of applications. First, the approach can be employed to rapidly identify lots impacted by an incident by navigating ascendant and descendant links between raw material lots, intermediates and finished products. Second, it can help identify in which specific lots a particular product has been used.
Third, automated techniques can be used to find which equipment items have been impacted by a given lot. Fourthly, the approach enables organisations to use records to find the history of a manufactured lot, typically including steps performed, relevant process variables and quality controls.
Finally, it enables users to compare manufacturing and quality parameters both at different steps of the same lot and between the same steps of different lots.
Plotting a typical scenario
So, let’s consider how electronic traceability techniques typically apply to a product development process, where the product is made up from two raw materials – A and B.
- Batches of raw material A are delivered by suppliers A via intake plant.
- Batches of raw material B are delivered by suppliers B via intake plant.
- These batches are processed in process plants A & B respectively.
- When processing is completed, batches A & B are pumped from process plants A&B to the continuous reactor via flow meters A&B and valves A&B.
- The reactor operates continuously and a plug flow model is assumed for simplicity.
- Product leaves the reactor and transfers to either of storage silos 1, 2 or 3 via valve and flow meters 1,2 & 3 respectively.
- From the silos, the finished product is then shipped to customers.
Throughout this product development process, manufacturers need to have visibility of a broad range of issues. Typically, these might include knowing the answer to questions, such as, “ In which lots of the finished product did batch A of raw material A end up?” or “which customers were these lots supplied to?”
At any given time, manufacturers might sometimes need to know, for example, which batches of raw materials A & B made up lot 1 of the finished product, which supplier provided these batches, what material was in the reactor, where did it come from and where did it subsequently go?
The problem with addressing these scenarios is how to handle material flow through the reactor itself. The batch concept is ‘lost’ in the reactor, so a method is needed to enable a trace to traverse the continuous flow region and link the reactor upstream and downstream batches. Using time models, it is possible to create the necessary linkage through the reactor from the process area to the silos area.
Implementing an effective solution
In order to fully support traceability through the process industries, tools need to be sophisticated enough to deal with a broad range of issues. First, they need to be able to collect different types of data electronically.
In a typical product development process, this includes manual data from pallets, raw materials scans and process automation data about temperatures and pressures used in the product development process. This will typically incorporate batch data, including details of product quantities, sources, destinations and times of despatch and arrival, and supply chain data typically relating to the distribution process.
Second, solutions will need to model certain interactions in order to capture relationships across the process, where materials are mixed together or where techniques, like plugged flow, are typically used.
When all this disparate information has been collected and captured, then the information needs to be stored into a database and a user interface provided in order to navigate it quickly and easily. Detailed analysis software is also needed to analyse the data, evaluate issues, pinpoint their source and find the underlining cause.
In this context, a software solution for traceability will address the core manufacturing function and the broader supply chain can be deployed across many process industries and easily integrated with many other systems. AspenTech is a perfect example of a leading software solution provider, which helps companies address these issues. The apenONE Traceability Solution offers the complete components (Manufacturing and Supply Chain) with the ability to collect and capture data and ‘interrogate’ it to find the source of problems across the manufacturing process. The additional benefit of these tools is that they successfully integrate with systems, including DCS, LIMS and ERP.
The time is right for companies to recognize that implementing traceability will identify the weak elements of the production system and also become an important tool for continuous improvement. When internal controls are tightened, the risks of defects escaping entering the system will be significantly reduced. l