Compliance Management / QRM Process / QRM Tools

Crazy About Quality and Compliance?

All elements and levels of the organization must be engaged to create effective manufacturing processes

By Michalle Adkins, Director, Life Sciences Consulting, Emerson Automation Solutions

Are you passionate about quality and compliance? If not, you should be. The most effective companies know how to meet the industry’s stringent regulatory requirements while manufacturing safely, efficiently and profitably.

Have you ever stopped to ponder how many things can go wrong during the planning, manufacturing, testing, reviewing, releasing and storage of a batch? Thinking back to my production management experience at a pharmaceutical manufacturer, I can recall my own amazement at the number of things that could and did go wrong, even when the production process was supposedly fully automated.

I was equally amazed that while running a rather manual process we somehow managed to prepare, manufacture, document, test and release batches without a deviation or problem. Unfortunately, at that time, this error-free state was a rare and amazing feat worthy of a celebration.

Fortunately, we now live in a world where at least some of this turmoil can be averted with appropriate planning and the use of modern automation and technologies. There are several sources to consider when looking at how to “poka-yoke,” or error-proof, manufacturing processes. Error-proofing can aid in achieving compliance, and figuring out how to get there is the key. The mantra is, as Stephen Covey says, “Begin with the end in mind,” and it’s important for everything we do in this industry.

Sifting through quality and compliance challenges brings to mind critical attributes we see working with many companies: Successful manufacturers supply quality products by putting compliance-ready processes in place from research through commercial manufacturing, within the supply chain process, as well as on the shop floor and in the labs.
Do you think this may be why we hear so much about data integrity, data analytics, continued process verification, PAT, electronic batch records, electronic log books and predictive analytics? These are not just buzzwords, but are several of the right-first-time or compliance enablers used to produce beneficial products that ultimately improve the global quality of life — yours and mine.

Taking a multi-dimensional view of successful organizations, there are many places to build in compliance enablers. Starting in the pipeline process from R&D to commercial manufacturing, here are some of these enablers: build process understanding, design capable processes, and deliver appropriate controls. Design of experiments and PAT are also important pieces of this process. In addition, tools enabling process control, product data collection and recipe management across the product lifecycle are pertinent as well.

With appropriate modeling tools developed and transferred across the lifecycle into the commercial manufacturing environment, process fault detection and predictive diagnostics can be used to identify, alert or avert production problems.

Looking at another dimension, manufacturing business processes include shop-floor components all the way up to the ERP system, and everything in between. There are many useful, compliance-enabling tools in this dimension.

Reliable flow, temperature and pressure instruments provide insight into the process. Analyzers verify product composition and quality. Automation systems and actuators act on these measurements to control the process.

Diagnostics, predictive sensing, process analytics, electronic batch records, electronic log books, process verification tools and predictive reliability tools enable right-first-time manufacturing. Looking across the supply chain network, many of these tools need to be shared with contract manufacturers and suppliers.

Successful organizations have a right-first-time culture, and view technology as a tool to provide talented people with the right information at the right time so they can make the best possible decisions.

Manufacturers must be passionate about quality and compliance, and committed to effective manufacturing. Companies with these attributes can put compliance-ready processes in place from research through commercial manufacturing and within the whole supply chain. Right-first-time is a key part of compliance. Technology enables it in manufacturing, and organizational culture plays an important role in producing the best possible products.

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