Our clients have extensive experience and familiarity with CLIC, but for many of you out there, it is a new concept. Thus, I decided to write a multipart blog series discussing CLIC as a concept and how it can help your organization achieve the required level of compliance.

Our QMS as a Self-Learning System – a different perspective

At the heart of a QMS is the rule-based Core, a multi-layered set of Procedures and Data Structures (forms) that define the architecture and stipulate the operation, interoperation, and behavior of an organization to achieve consistent high value results.

In most implementations of a QMS, the CAPA process initiates changes to the Procedures to effect updates, corrections or improvements that address the difference between the actual or predicted performance of the QMS vs. the desired ideal performance.

The QMS can thus be rationalized into a simple operational block diagram; the procedural rule- based component represents the output and actuator of the system – the component that controls the business operation. The CAPA function is considered the instigator of changes to the procedural core based on various input events.

It becomes apparent that this is a closed loop system (i.e., a system that calculates the difference, gap or error between the desired outcomes and the actual outcomes and returns the result for evaluation as effective or non-effective). For any given input, it may take just one loop or perhaps more iterations through these steps before the desired system performance/outcome is achieved; conceptually each of these iterations is a step towards (convergence on) the desired optimal outcome.

The Procedural core of this system is quite unlike a typical static control algorithm in that it is adaptive and is modified on an iterative basis to improve its performance. This is actually the basis for a Self-Learning system or a Neural Network1.

If we now consider a business organization as a competitive entity in a market with numerous competitors, then apply the principles of Game Theory2 for Strategic advantage, we could conclude that advancing the learning and thus optimization of the QMS faster than the competitive field could lead to superior business success from higher quality, more efficient operations at a reduced risk.

In an ideal world, businesses would be able to measure the speed of their QMS self-learning towards the ideal optimized state, the Optimization Velocity. We would then expect to see a significantly higher Optimization Velocity (at lower cost) for a business with CLIC vs. a standard QMS as a result of significantly improved efficiencies in initiating and processing CAPAs within the integrated QMS environment.

If you’d like to learn more about CLIC, feel free to reach out to me directly. Also, if you have any quality, regulatory, or staff augmentation needs, then EMMA is the right service provider for you. We are better than the competition because we provide our clients with a true consulting experience. We can be reached at 248-987-4497, or info@emmainternational.com.

1 Michael A. Nielsen, “Neural Networks and Deep Learning”, Determination Press, 2015, http://neuralnetworksanddeeplearning.com/chap1.html#perceptrons

2 Financial Post: “Using Game Theory to Improve Strategic Decision Making”, Mitchell Osak, July 24, 2010, https://business.financialpost.com/executive/using-game-theory-to-improve-strategic-decision-making

Carmine Jabri

Carmine Jabri

CEO - As co-founder of E.M.M.A. International Consulting Group, Inc., Carmine Jabri, PhD, MSJ, MSQM, MHA serves as EMMA International’s CEO. Dr. Jabri is an experienced Quality Assurance & Regulatory Affairs professional with more than twenty years of experience implementing, improving, and directing Quality Management Systems and compliance operations. His career includes expertise in the Pharmaceuticals, Medical Device and Biologics industries. Dr. Jabri serves on the Food and Drug Law Institute’s Medical Products committee and is an internationally sought-after quality systems expert. Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration, and a Bachelor of Science in Chemistry.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This