Statistical process control: is it the right business strategy for you?

Ph.D. fellow at the Technical University of Denmark

Bzhwen A Kadir

Ph.D. fellow at the Technical University of Denmark

 

Bzhwen A Kadir is a Ph.D fellow at the Technical University of Denmark (DTU), engineering systems division, researching on designing new ways of working in Industry 4.0 and aligning humans, technology, and organisation to enhance productivity and human well-being.

Kadir holds B.Eng. in civil engineering and a M.Sc. in Industrial Engineering and Management from DTU. Prior to his Ph.D. studies, Kadir worked as a consultant in Applied Manufacturing Science at NNE, assisting large pharmaceutical clients with R&D and production related improvement and compliance projects through the application of Lean and Six Sigma tools and methodologies.

 

 

Developing robust statistical process control (SPC) can do wonders for your quality control. But where do you begin when outlining this strategy? The pilot, of course. And that happens to be the most critical step.

 Statistical process control is a great business strategy to consider if your company is experiencing one or more of the following issues:

  • Variation in yield or product quality
  • Random component errors
  • Verifying effect of error correction
  • Anchoring optimisation projects
  • Meeting recent regulatory requirements regarding process verification

Where to begin?

The foolish man built his house on sand and the wise man on rock. The same goes for SPC – the success is in its foundation, or rather, a successful pilot.

Figure 1 - Statistical Process Control

Every company is different and thus, results differ as well. However, the basic steps to achieve a strong control strategy are the same. Manufacturers must begin with a pilot project focused on developing and customising an SPC system that corresponds to a company's specific processes. Additionally, manufacturers would do well to prepare the entire organisation by creating awareness and defining new roles and responsibilities so everyone can embrace the change.

The ability to react flexibly is crucial in the initial phases of preparing for statistical process control implementation.

Bzhwen A Kadir, Ph.D. fellow

A journey founded on science

Successful SPC implementation requires more than just software installation. It is a journey founded on science and risk-based analysis. You need to identify critical aspects of the process, establish reliable process measures and indicators and determine the relationship between a healthy process and products.

Figure 2 – The building blocks and necessary elements in successful implementation of SPC and CPV

 

Agility – the key ingredient

Finally, the ability to react flexibly is crucial in the initial phases of preparing for statistical process control implementation. This is true not only in regards to the system, but also the involved organisation. Working with control charts requires a change in approach - from being reactive, to being proactive.

Therefore, it is important to have an engaged group that can adapt as the project evolves. A shift from iterative learning processes to fully standardised working procedures will occur as roles, requirements and action plans start to form.

 

TechTalk

Recording: Manage the challenges of pharma 4.0

Control strategy is hot right now - it's a requirement, and it's good business. It is also a focus point for the FDA, issuing 5 warning letters in August and September alone. Get up to speed on control strategy with this webinar.

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