September 5, 2019
By Joe Schutte
In a high-volume manufacturing environment, the factory floor is where all of the action happens. It is on the factory floor that items arrive as components and leave as products, slotted to be sent to the next factory for further processing or shipped to distributors to be sold. It is here, too, where product quality and safety are either made or broken.
Let’s explore a recent example. In July, Altaire Pharmaceuticals, Inc announced a recall of over-the-counter drugs shipped to CVS as early as September of 2016 and as recently as June of 2019 due to concerns over the sterility of its products. If unsterile, the products in question could lead to serious and potentially life-threatening infections. What was the cause of this concern? The official FDA notice states the voluntary recall was, “due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.”
The official FDA notice states the voluntary recall was,
over critical systems in the manufacturing facility.”
In short, this particular recall came down to the manufacturers’ inability to determine with confidence that standards for sterility were maintained throughout the manufacturing process. And the pharmaceutical space is just one example. In material manufacturing, product integrity can be compromised by a minute change in factory conditions, such as process temperature or pressure. In food and beverage, a product can be spoiled by a temporary lapse in storage conditions or cross-contamination by a potential allergen. It is impossible, therefore, to address product security comprehensively without also considering practices and processes occurring on the factory floor.
But which factory system is responsible for matching quality practices to individual products? Unfortunately, for many factories, this need is unmet by current systems. While it is true that standard manufacturing execution systems (MES) often provide equipment integration to monitor factory conditions, controls, and processes, this data is rarely linked to individual products. The problem lies in the primary objective of the MES. Such systems are designed to optimize process and not necessarily product. Therefore, the MES’s factory floor data typically focuses on understanding quality throughout the factory, and not for each product in the line.
Addressing the quality of each and every product requires a specialized solution. Let’s take a closer look how the right product security and forensic traceability solution can enable granular product quality control at scale.
USE CASE
Read Now
First, the right solution will integrate with mission-critical factory equipment to gather key inputs about production practices—from documenting each step in the manufacturing process, to monitoring conditions like temperature and pressure, to alerting operators of equipment failures before they impact production. These sensor-based inputs are foundational to understanding quality at a product level.
It’s not sufficient to collect sensor-based data inputs from factory equipment. In order to define the relationship between factory processes and product integrity, the solution must link this data to each subcomponent and product on the factory floor. Leveraging serialization and authentication, operators can then decipher which products were subject to process compromises and are therefore at risk for subpar performance or safety.
Using this data, manufacturers can proactively address process failures and eliminate product-in-question before it ever leaves factory doors. Moreover, examining the relationship between factory conditions and products empowers manufacturers to make minute adjustments to conditions and processes that maximize the quality of each and every product produced. Finally, by examining this data on a macro level, manufacturers can quickly identify and close off product quality gaps, and develop targeted initiatives for continual quality improvement.
Raising the Quality Standard for Every Product with ProLinc®
As a product security and forensic traceability solution, ProLinc® follows each and every product through the entire manufacturing process, building a digital genealogy containing critical insights related to authenticity, quality, and safety. By integrating with sensors on factory equipment, ProLinc® provides the critical link between factory processes and product quality that is needed to manage product security in today’s high velocity, high volume manufacturing environment.
Ready to bring forensic traceability to your factory floor? Talk to an expert to learn how our solution can integrate seamlessly into your environment.
Tags: factory data, mes, quality controls