Preventing Recalls through Real-time Quality Control

Product Recall. Just hearing the words is enough to make manufacturers nervous – and rightfully so. Recalls cost companies billions of dollars each year. It often takes a business years to recover from the initial recall costs, legal expenses, lost sales and negative consumer perception.

For many manufacturers the largest culprit in product recalls is often preventable human error. Manual manufacturing processes have no cost effective way of monitoring or recording shop floor activities. Nor do they have a way of catching errors before product is affected.

Manual paper systems rely on data being entered timely and correctly. The problem with this system is that humans make mistakes, processes are not always completed accurately, data is not always entered correctly and paperwork takes time to enter. The result is a potential for mistakes slipping through that can affect product quality, eventually resulting in recalls.

So how does a company protect itself? The answer is implementing a system which ties manufacturing operations with inventory and quality, all in real-time. A good chemical management system consists of manufacturing execution, inventory, formulation and LIMS. It will prompt and police employees through the entire manufacturing process, guaranteeing the use of the proper raw materials, enforcing quality rules and communicating with scales and other equipment to ensure that accurate processes are followed.

The best manufacturing systems pull process instructions from formulation software, raw material information from LIMS and inventory software, and feed the data through the manufacturing execution package to the end user. The system then guides shop floor employees through the manufacturing process checking each activity as it is performed, allowing them to continue on to the next item only when the current activity is executed correctly.

The system records every activity in real time updating manufacturing, quality and inventory with every transaction. The combination of guiding employees step-by-step (often called “prompt and police”) and recording each piece of data in real time eliminates the opportunity for human error and guarantees accurate, real-time data.

Companies who utilize this technology reap a host of benefits:

  • Increased productivity on the shop floor
  • Prevention of human error in product selection, over/under dispensing, blending and data
    entry – resulting in less waste
  • Significant reduction in recall risk, which also increases customer satisfaction
  • Improved product quality and repeatability
  • Accurate inventory records
  • Complete traceability of shop floor activities

If you are evaluating an upgrade or implementation of a new solution to achieve these benefits, there are a number of consultants and service providers that can assist. As part of your evaluation, be sure that the solution provider you select can deliver the following capabilities:

  • Direct integration with equipment (e.g. scales, dispensing systems, etc.) as well as to other third party enterprise applications, such as Enterprise Resource Planning (ERP)
  • Lot and container level inventory tracking
  • Policed maintenance of critical equipment including scales, vessels and other equipment
  • Prompt and police style formulation and execution
  • Designed specifically for wireless operation
  • Extensive use of bar codes
  • Tight integration with the host system
  • 21 CFR Part 11 compliance (for FDA regulated industries) to support the need for
    digital signatures and approvals

In conclusion, the question you need to ask yourself is how do your operations processes compare to those of your competitors? If you are operating with a decade old system filled with manual processes prone to human error that can’t deliver real-time results, then you might be at a competitive advantage if your competitor elects to install a new system. While the benefits may appear to be more long term and gradual, over time these differences can make the difference between thriving and surviving or not. If no one in your industry has elected to venture down this automation path, then your investment in such a system could be a disruptive event – and an opportunity to take a leadership position. Either way, significant opportunity awaits those companies that decide to invest in next-generation solutions to improve efficiency, throughput and performance.'

Susan Balsamello'

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