The Waters Difference: Building Quality into Everything We Do – From A to Z

“The master in the art of living makes little distinction between work & play, his labor & his leisure,” said James Michener, Pulitzer Prize-winning author. While I am still mastering the art of living, I have been most fortunate to absolutely love my work. I’m Ed Grover, and I am the Director of Engineering and Product Development at our Chemistry Manufacturing Facility, in Taunton, Massachusetts, where I have worked for the last 36 years.

Build Quality into Every Step of the Process
In Taunton, MA, we synthesize the sorbents contained within our key chromatography and sample preparation products, and everything we do is focused on making sure our customers receive high quality products, on time. It’s my job to ensure quality is built into every step of the process. Most of our sorbents start with the basic raw materials and we take them through several processing steps to the final particles, before they are packed into our columns and sample preparation hardware. At each stage, we perform rigorous quality control testing to ensure batch-to batch repeatability.

 

Everything we do is focused on making sure our customers receive high quality products, on time.

Higher Manufacturing Frequency = Better Quality Control
To ensure we are gathering sufficient statistical data and maintaining the manufacturing skills of our chemists and engineers, we typically manufacture any given sorbent between four to eight times per year. This frequency means we are very familiar with the process. We monitor the in-process chemical and physical parameters that impact the final chromatographic response factors and monitor our control charts very carefully.

How does this benefit our customers?  This gives us better control over our manufacturing processes and allows us to minimize the risk of out-of-specification intermediates all the way through to final products. Simply put, our batch-to-batch repeatability provides confidence that our columns consistently deliver the expected performance throughout its lifecycle – today, tomorrow, and in the future.

Higher manufacturing frequency gives us better control over our production processes which allows us to minimize the risk of out-of-specification intermediates or final products reaching our customers’ laboratories.

Several times, our customers have asked us why we don’t make our own lives easier and scale up production to produce very large batches of sorbent every few months, or even years. They asked us if this would not be a better way of guaranteeing product quality – by providing the same batch for a longer period. We understand that some chromatographic vendors operate this way, but we believe that this strategy does not allow for long-term, sustainable statistical control and consistent product quality. Imagine if we didn’t create a batch for a couple of years, and then something went wrong?

Continuous Improvement is Key for Ensuring Quality
Our manufacturing operations are supported by a highly skilled chemistry technical support group, comprised of chemistry graduates and PhDs. This team are thoroughly trained on chemical and analytical processes, statistical analysis, and problem-solving techniques. They play a key role in new product introductions, as well as continuing to improve the manufacturing process of our existing products, which includes identifying risks in our supply chain. Any change to our processes is governed by our ‘Management of Change System,’ an internal quality system which defines our current state, the desired future state and summarizes potential benefits and risk impact.

Through the optimization and evolution of our organization, quality system, technologies – and some very hard work – we routinely achieve 97% first pass quality of our bulk material. Over the past five years, we have reduced scrap by a factor of six and reduced special-cause batch failures by a factor of three. Our sorbents are shipped to our packing facility in Wexford, Ireland.

Even through the SARS-CoV-2 pandemic created some global logistical issues, we managed to deliver 99.8 % of our sorbents on time.

As we look to the future, we are currently in the final phase of constructing a new $215 million manufacturing facility to increase capacity and automate routine tasks. We are doing this to ensure that we can continue to meet the demands of our customers, providing high quality products, on-time.

Building Quality into Everything we do – From A to Z

To finish, I wanted to share that the favorite part of my job is when I get to interact with colleagues and customers around the world. I love showing how we care about building quality into everything we do, and I’ve benefited enormously from these interactions. Read some of my favorite stories in a future blog. I look forward to the time that we can all meet again in person.

Additional Resources

Quality Video

Infographic: How Product Quality Translates to Better Results

Blog: Advancing Science Together for a Better Tomorrow