I was asked one day to explain and to describe my professional job. Based on my educations, skills and job experiences, I used to deal with quality and Good Manufacturing Practice (GMP) principles in Bio-Pharmaceuticals, Foods and cosmetics. I finally considered to qualified myself to improve human being by collaborating to deliver a quality and validated product.

Indeed, my professional activities help developing products that meet their intended specifications. How do I do that in day-to-day basis? I simply use to apply the following five (5) lifecycle principles.

the 5 Key lifecycles - Mivado GP

A. PLAN-DO-CHECK-ACT (PDCA) CYCLE

The plan-do-check-act cycle is a four-step model carrying out change. Just as a circle has no end, the PDCA cycle should be repeated again and again for continuous improvement (1). PDCA, sometimes called the "Deming Wheel," "Deming Cycle," or Plan-Do-Study-Act (PDSA) was developed by renowned management consultant Dr William Edwards Deming in the 1950s. He found that the focus on Check is more about the implementation of a change. Deming's focus was on predicting the results of an improvement effort, studying the actual results, and comparing them to possibly revise the theory. He stressed that the need to develop new knowledge, from learning, is always guided by a theory (2).

B. DEFINE-MESURE-ANALYSE-IMPROVE-CONTROL (DMAIC) PROCESS

DMAIC is a data-driven quality strategy used to improve processes. It is an integral part of a Six Sigma initiative, but in general can be implemented as a standalone quality improvement procedure or as part of other process improvement initiatives such as lean (1). DMAIC is a data driven improvement cycle designed to be applied to business processes to find flaws or inefficiencies – particularly resulting in output defects – and to combat them. The goal of employing DMAIC is to improve, optimize, or stabilize existing processes (3).

C. PROCESS VALIDATION

The Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product (4). Process validation involves a series of activities taking place over the lifecycle of the product and process. This lifecycle approach links product and process development to the commercial manufacturing process, and maintains the process in a state-of control during routine production.

D. RISK MANAGEMENT

The risk management is a process, a structured way to think about risk and how to deal with it. The Risk management is also the process of identifying, assessing and controlling threats to an organization's capital and earnings. These threats, or risks, could stem from a wide variety of sources, including financial uncertainty, legal liabilities, strategic management errors, accidents and natural disasters. Per ICH Q9, the quality risk management is systematic process for the assessment, control, communication and review of risk to the quality of the drug product across the product lifecycle.

E. FIVE (5)S METHOD

The original 5S principles were stated in Japanese. Because of their proven value, they have been translated and restated in English. 5S consists of five practices; Sort, Straighten, Shine, Standardize and Sustain. (The Japanese equivalents are Seiri, Seiton, Seiso, Seiketsu and Shitsuke).The 5S is a mantra of sorts designed to help build a quality work environment, both physically and mentally. It’s one of the most popular methods used to create lean functional work environments (5). The 5S Method is a standardized process that when properly implemented creates and maintains an organized, safe, clean and efficient workplace. Improved visual controls are implemented as part of 5S to make any process non-conformance’s obvious and easily detectable. 5S is often one element of a larger Lean initiative and promotes continuous improvement (6).

Applying these cycles through my business contribute and allow controlling; and continually improving processes and products by using all available workplace assets. Using these 5 key lifecycles helps understanding the process variability in order to improve it. As said W. Edwards Deming, ‘’In God we trust, all others bring data’’.

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REFERENCES

  1. The American Society for Quality (ASQ), http://asq.org/learn-about-quality/project-planning-tools/overview/pdca-cycle.html, Accessed: 2018-10-20  
  2. MindTools, https://www.mindtools.com/pages/article/newPPM_89.htm, Accessed: on 2018-10-20
  3. Adam Henshall, DMAIC: The complete guide to Lean Six Sigma in 5 Steps, https://www.process.st/dmaic/, Accessed:  2018-10-20
  4. Guidance for Industry : Process Validation: General Principles and Practices, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf, Accessed:  2018-10-20
  5. What is 5S method?, BDC, https://www.bdc.ca/en/articles-tools/operations/operational-efficiency/pages/lean-manufacturing-using-5s-method.aspx, Accessed: on 2018-10-20
  6. 5S Methodology, https://quality-one.com/5s/, Accessed: 2018-10-20

About the Author

Kossi D. Molley, Chemist, GPP, QMS, CQV & Compliance