Today’s plant manager is tasked with monitoring product quality, adapting to regulation, and vetting new technologies. Ensuring safety and compliance inside production environments has only become more important in the COVID-19 era - but are the tools manufacturers use to gather internal plant data sufficient?
Take one scenario from a recent customer meeting: a national dairy producer was forced to dump a large batch of milk after a false-positive test for salmonella. Under current protocol, this test was taken manually by a lab technician and the result went unnoticed for hours. Four previous tests and three hourly tests after were all negative for salmonella, but when queried about the positive test, the lab technician was unable to remember why she wrote what she did. Out of an abundance of caution, this national producer had no choice but to discard the entire batch of milk.
How did this costly error occur? Simply put, the process for procuring internal data was fraught with complications. In this instance we can observe how several factors turned one small mistake into a facility-wide setback:
Manually collecting scientific data exposed the production site to inevitable human error
The lack of automatic data upload meant hours of delay before QA departments could analyze clearly erroneous results
Failure to react in near real-time ultimately compounded total volume of product lost
Mistakes like this are a nightmare for plant managers. Production stops, product is destroyed, and the appearance of bad data casts a shadow over the entire compliance process. These challenges come as no surprise to our team at Phizzle as manufacturers repeatedly stress that the daily process for procuring accurate and auditable compliance data is painstaking.
Today, collecting accurate scientific data inside these production environments is a thoroughly manual process. For particle counters, which are critical to measuring the air quality in production environments, workers are deployed each day with a pushcart and a recording log to walk the length of their facility. These technicians flush each measurement device to prime it for testing, run the device, physically record these results, and then flush it again. The compliance data that is generated for regulatory review or internal use is logged by hand or printed out on cashier tape. At a break or end of day, this technician’s log is hand-delivered to another department for entry into the Lab Information Management System (LIMS). Manual operation and data transmission make this process labor-intensive and error-prone, while many of the scientific devices used for testing produce variable data formats. Simple variance like particles per million or particles per cubic liter of air also opens up QA departments to additional complexity on the backend of data entry.
Consistency and auditability are the keys to compliance. Manufacturers must be able to depend on precise measurements when reporting data to agencies, whether it be the USDA, SQF, EPA, or FDA. Logging results by hand, dealing with non-standardized data formats, and being unable to report results in near real-time turn what could be a one-person job into a growing list of compliance deadweight for these industries. At Phizzle, we look at this environment - heavily regulated, labor-intensive, and using a disunified fleet of edge devices - as a perfect opportunity for automation.
What if this entire testing and compliance process could be done remotely, from a single UI?
Consider the value of automating scientific particle counters alone. These devices are commonly used in regulated manufacturing to measure contaminants in production environments. Each particle counter runs multiple tests per day across every active part of a production facility, which amounts to hundreds of particle counters and lab technicians at scale. These particle counters are relatively cheap yet their operational costs are staggering when annualized. Reducing the total number of lab technicians, backend QA analysis, and overall human error each contribute to compelling ROI for automation. One pharmaceutical manufacturer estimated that Phizzle’s EDGMaker solution could reduce annual particle counter operating costs by over $100,000 per device. And they have nearly 2,000 particle counters - ideal scale to implement an IIOT solution.
These savings from automation drive value and can apply to any regulated industry operating these devices. A good example of an adjacent industry that uses particle counters in a different way is hospital cleanrooms used to hand mix pharmaceuticals for patients. These rooms must adhere to the highest air quality standards as outlined in USP 797 and USP 800 regulations. Automating the operation of particle counters in cleanrooms can ensure compliance and streamline record-keeping for assessment. Recent studies also indicate that the leading cause of cleanroom contamination is employees entering the room. By remotely operating these devices, it eliminates the need for hospital lab technicians to enter the room just to initiate an air quality test.
Regulation and data demand are unavoidable realities of modern manufacturing. Phizzle’s EDGMaker simplifies the entire regulatory process through automation and creates three main value drivers for digitizing data collection in these environments:
Reduces labor costs for lab technicians to manually operate scientific devices
Normalizes data reporting to eliminate back-end conversion requirements
Removes factors for human error and batch dumpage due to bad data
These benefits provide real business value in multiple use cases across various industries. Phizzle’s EDGMaker paves the way for customers to realize these benefits in a multi-vendor and highly non-standard environment. If your business encounters similar challenges to the ones outlined above, please request a demo or reach out to our team at sales@phizzle.com. - Jeff Cristee, Chief Revenue Officer