Traceability is more than just a process of tracking events in the supply chain; it’s a method of being customer centric. Steven Kratsis writes.
THE need for manufacturers to focus on compliance and traceability initiatives is increasingly significant 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 be able to successfully reduce inefficiencies within the supply chain.
Technology can be used to track system status, analyse system performance and support decision making. 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, 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 obsolesce, 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.
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.
In many organisations today, opportunities for process quality enhancements are being lost because genealogical data is so hard to attain. Traceability helps organisations improve the efficiency and pertinence of quality controls, while at the same time reducing costs by decreasing non-conformities.
Scoping out the challenge
Many organisations across the process industries, particularly those in the batch industries like consumer products and pharmaceuticals are still using manual approaches to traceability.
This presents a variety of problems as organisations need to keep a history of transactions, stretching back as many as ten years to comply with regulations and this entails retaining a significant amount of paper.
Most 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.
Some organisations are now looking to digitise the process but the sheer weight of paper that will need to be moved before this can happen makes this a challenging task indeed. It is important that data is collected and analysed electronically.
A myriad of uses
To 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, 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.
Implementing an effective solution
To fully support traceability, sophisticated tools are needed to deal with a broad range of issues.
In the 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 incorporate batch data, including details of product quantities, sources, destinations and times of despatch and arrival, and supply chain data 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 used.
When all disparate information has been collected and captured, 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.
Traceability should not been seen merely as a process of tracking events in the supply chain, it’s a method of being customer centric, enhancing service excellence and achieving commercial success by developing a genuine value chain.
[Steven Kratsis is Country Director, AspenTech Australia 02 9572 5544, www.aspentech.com]