Capture Traceability for Increased Product Quality and Regulatory Compliance

Potential Value Gains – Track & Trace
Reduce Labour costs associated with collecting paper records
Save more than £100,000 for a single recall
Eliminate or reduce packaging issues

Product Genealogy

Genealogy has become an increasingly important factor in Manufacturing, having the ability to identify all parts, materials, and components that created a final product has been led by the increased demand for complete traceability from stakeholders including; regulatory compliance, retailers, suppliers and consumers. The ability to track, trace and record the genealogy of raw materials and Work In Progress (WIP) throughout each stage of the production process and product life-cycle is imperative. The ability to track and trace a product from ‘Farm to Fork’ will lead to increased product quality, safety, transparency and greater recall responsiveness, full genealogy will help eliminate the risk of cross contamination between batches. Product Genealogy will reduce the cost of product recall and the damaging affects to brand reputation caused by poor quality products.

Regulatory Compliance

Compliance requirements are regularly changing and emerging; having a traceability system in place to demonstrate auditable compliance and product genealogy is essential to lowering the costs caused through regulatory compliance. Fixing quality problems can be very time consuming and costly, but eliminating common quality problems and reducing the number of defect products makes for a healthier bottom line. Having real-time and historical data  is required to meet regulatory compliance and customer audits. Improving Electronic Batch Records (EBR) to meet regulatory requirements is vital, as traceability of raw materials throughout the production process is critical to ensure legislation is met, whilst protecting customers and branding.

Audit trails

Handling high volumes of traceability data including audit reports/logs when a product recall occurs can have a real impact on operational performance. Providing the reports in a timely, effective manor is key, yet paper trails documenting the history of a product throughout the supply chain can be difficult to control, and unreliable. Documented audit processes, electronic signature sign-off,  and electronic records can help to maintain and achieve compliance with regulatory requirements such as 21 CRF Part 11 and ease the audit process altogether.

Errors in Manual Data

Manual paper based data processes can often lead to inconsistent and poor data accuracy resulting in poor intelligence to base decisions on. These challenges can be overcome by implementing an electronic paperless data platform to enable greater visibility and increase data and reporting accuracy across the entire manufacturing enterprise, including; production, quality, maintenance, inventory, and supply chain. Disparate quality, traceability and genealogy data from multiple sources can result in nonconforming products having a major impact on product safety and quality. However, track and trace systems can reduce this risk by allowing easy access to information and records in the event of a product recall. Replacing paper documentation with Electronic Batch Records (EBR) will minimise recipe or batch errors, and involve operators in the quality improvement process, whilst easing collaboration between departments.

Product Recalls

Capture and manage critical quality-related events, providing the capacity to involve and engage personnel in quality initiatives and improve product safety and recall responsiveness. Capture traceability data from across operations to prevent quality events such as product recall from happening, and to contain and take control of a recall if one should occur,  enabling optimum product and safety recall responsiveness, whilst protecting the brand. Improving the recall process and containing the quality problem before it continues through the distribution supply chain can mean escaping from costly and damaging recalls. At least having accurate genealogy and traceability ensures that recalls can be targeted quickly and efficiently to reduce the impact of the recall.

Product labelling

Do you have significant issues related to ensuring the correct product packaging and labelling? Product labelling involves high level identification of groups or lots of production. Finished goods lot identification throughout the supply chain can help monitor and record raw material usage as well as capturing real-time production data such as process variable trends, HACCP (Hazard Analysis and Critical Control Points) tasks, quality tests, operator approvals, and performance events. Unique product identification systems such as Radio Frequency Identification (RFID) and barcode scanning technologies can aid traceability efforts and help improve inventory management.

Stock & Material movement

MOM (Manufacturing Operations Management) systems integration eases traceability of raw materials throughout the whole process, tracks raw materials and WIP, and aids the integration of barcode or RFID technology for mix-up prevention and traceability. It also helps interface to Enterprise Resource Planning (ERP) systems for stock management, work order creation and helps monitor planned vs actual material usage. Item and location structures can be used to track the actions, statuses, and movements of various physical items throughout the manufacturing environment, and users can also track and record resource transfers in and out of inventory with the storage systems function. Track and trace solutions allow manufacturers to detect and report the physical location of products in real-time, and manage logistics and quality more effectively leading to a better inventory management.

For further information about track and trace systems please call us on 01274 599955 or email us here

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