Manufacturing Regulation & Traceability
Manufacturers are facing ever increasing competitive pressures and legal requirements.
It is easy for complications to start when error prone manual operations are not running effectively. According to ISO 8402, traceability is the ability to trace the history, application or location of an entity by means of recorded identifications.¹ To combat issues, manufacturing processes are becoming increasingly automated. This involves the capture, storage and management of information plus the use of technology. Traceability collectively ensures that product quality standards are met and helps adhere to regulations. Additionally, manufacturers can gain real time information about the production and equipment.
Traceability acts as a risk-management tool, and takes two forms. The first is product tracking which is the capability to follow the path of a specified unit of a product through the supply chain as it moves through organisations.² This is necessary in the manufacturing industry to yield a structured and holistic approach to managing daily operations. The second form is product tracing which is the capability to identify the origin of a particular unit and/or batch of products located within the supply chain by reference to records held upstream in the supply chain.² This can be necessary for instances such as product recalls and complaints investigation.
Records and traceability indicate the authenticity of a certain item or material etc. Without the correct product knowledge, the manufacturing process can be hindered and slowed, leading to poor quality manufactured products or no products at all. It is also practical as it helps companies adhere to government regulations, lessening product recalls. Figure 1 below shows what each component of a track and tracing system provides to the chain of a manufacturing process.
Figure 1
The desire for visibility in the manufacturing process, customer satisfaction, profits and regulation compliance is pushing many to look at traceability as their long term solution. Many have discovered that implementing a traceability program is a proven method to meet their strategic goals.⁴ The benefits to implementing a traceability system are monumental, and can result in; increased revenues, improved customer satisfaction and reduced manufacturing liabilities.
The below are a few suggested results of implementing traceability;⁵
Increased customer satisfaction & safety
In the event of a recall, manufacturers are able to minimise the impact by only recalling items with specific serial numbers built with the faulty item, therefore reducing expenses and customer impact.Meet government and compliance mandates
Real-time visibility helps food manufacturers meet the challenges of stricter government regulations, and general manufacturers can manage detailed product histories to meet discrete and process manufacturing standards and regulations.Improve data accuracy
Human error is significantly reduced as materials, parts and ingredients etc. are handled with technology. Product, ingredient, part, employee number, quantity and supplier information can be automatically captured accurately and timely rather than written on a tablet and transcribed into a computer system.Improve operational productivity
Additionally to the efficiencies gained through the removal of manual processes, businesses can save millions in lost revenue, recall costs, damage control campaigns, litigation and fines through the use of traceability solutions to prevent quality issues.Focus on generating revenue
With automation and traceability solutions for discrete manufacturers you can track warranty and part information to up-sell and cross-sell complementary products and services. In addition, labour hours can be reallocated to focus on revenue-generating activities versus the double reporting that occurs when data is collected manually and then later transferred into a computer system. And for process manufacturers, retailers are increasing their track-and-trace initiatives and supplier requirements, thus setting the stage for businesses that are proactive in taking steps to meet these changing demands to have a competitive advantage.
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¹ Costa, J. (2011). Why You Need Real-time Track and Trace Solutions Now. Best Practices for Traceability in Manufacturing. 1 (1), p1.
² Sandford, A. (2011). Traceability in the manufacturing process. Available: http://www.qmtmag.com/display_eds.cfm?edno=179989. Last accessed 07 Dec 2017.
³ Motorola. (2011). MUST-KNOWS THAT PROTECT YOU AND YOUR CUSTOMER. Traceability for Manufacturing, p4.
⁴ Balluff. (2016). Industrial identification to improve your process chain. Traceability in Manufacturing. 1206 (1), p4.
⁵ Motorola. (2011). MUST-KNOWS THAT PROTECT YOU AND YOUR CUSTOMER. Traceability for Manufacturing, p6.
