We live in a world in constant change. So, the desire to achieve perfection in what we do is just an ideal. What is possible and strategic is to achieve in every single step of a determined activities, better and better results by optimizing processes following a methodology that focus effort and strategy to what add value to our business and purposes.
The well executed continuous improvement program never stops; it is constant and integrated to the company goals. It is a perpetual cycle that with the assessment of the right metrics allow to assess Today´s performance with the future goals in mind. The objective is to be closer and closer to the future goals, and once achieved, establish new one to get better and better, investing resources, efforts and capital where really matters.
Kaizen: The Continuous Improvement Process
The japaneses brought wonderful concepts on process efficiency that were initially adopted and developed by the automovile industry (by Toyota “Lean Manufacturing”, several years ago) and now days reapplied to all kind of processes.
Kaizen means “change to improve” and require involvement of all people, systems, processes and organizational levels (from top to bottom) to warrant integration and high efficiency.
With the continuous improvement approach we minimize variations, remove redundancies, simplify processes, increase productivity and warrant that resources are invested where are required. Removing losses and maximizing gains.
Deming Cycle or PDCA Cycle
The process consist on doing small planned steps to improve a determined activity. The methodology is based on the cycle: Plan –> Do -> Check – > Act – > and restart again in a betteer state applying the learnings from the previous stage, establishing a improved standard and do this process continously. This is what PDCA means.
The PDCA Cycle. Figure taken from https://th.bing.com/th/id/OIP.HTwraLBxP5SFK0U1MBlruQHaE_?pid=ImgDet&w=474&h=319&rs=1
This process will bring positive results as long the team implementing the cycle understand clearly the business priorirites and strategies and leadership is in touch and understand team needs ie. Resource allocation, remove obstacles. Leadership and operations action planning should be linked and synchronized.
The methodoloy allow to focus in what is established as a priority and decision making is based on data compiled during the execution of the cycle.
The PDCA Cycle is fundamental for the continuous improvement process.
How this is linked to Quality? A Quality Management System enable the culture of excellence through continuous improvement process (see ISO – Quality management: The path to continuous improvement). Applying PDCA cycle and Kaizen culture applied to quality will contribute to the maturity of the quality program beyond compliance.
Principles – Happy patient (consumer), happy doctor (customer), healthy business (sales). My own summary of continuous improvement program is summarized in the following principles:
Leadership – leaders with vision to the future fully engaged with the operations, understanding losses and obstacles and actively providing solutions. Listening to a broad range of employees (all levels and diversity) to really understand what is needed to reach the goals. Assuring infrastructure, organizational structure and resources to warrant success.
Value Mapping – understanding cost: essential activities that generate value and those that are required/ needed by law and regulations. Establish the right balance to move forward and keep the organization healthy and components satisfied.
Stream Mapping – every process is a flow. It have its input and output. Every step is connected and influence the next one. A good understanding of the whole supply chain, demands, bottle necks, the requirements (resources, associated cost) and timings. All should be completely mapped to assure right level of flow and synchronization. Not more, not less. Smart metrics to really measure what its matter.
Effective Flow – establish preventive actions, buffers, to assure client/consumer/patients demands are met: efficacy, safety, quality, capacity, expectations. Targeting to the perfect product delivery, just in time, providing truly satisfaction -> delight. Knowing the risks, source of potential problems establish the preventive actions to avoid them. If failures occurs, review the data thoroughly, learn from it and correct them to avoid reocurrance. Assure following deliveries are improved versus the previous ones.
What can go wrong? Common errors
- Leadership not engaged. Deprioritize improvement and involuntary sabotage. Flow to the work from established action plan for continuous improvement to work mainly on crisis mode.
- Traffic light mentality. Focused on the reds, and doing nothing on the opportunity areas until they become reds; or leaders only focused on the Greens, rewarding the good news and punishing resources that communicate opportunity areas.
- Poorly executed investigations. Not enough time and resources allocated to fully understand deviation´s root-cause. Corrective actions not rigorously and scientific – based verified.
- Decentralized PDCA at each operation´s unit, not fully integrated to the general plan and units not understanding the Company vision.
- Lack of Capability. Assigning responsibilities of continuous improvement program to not qualified resources working in isolation. Resources focused on the financial metrics and not on requirements, capability or stream barriers. Productivity metrics not linked to organizational needs.
- Lack of recognition. Only awarding rescue effort during crisis.
- Short sight. Quality control focused on finish product testing and very few (or none) done on process control. Believe that continuous improvement is only for highly regulated industries, and nothing required for less regulated categories.
- Poor validation practices. No rigor validating processes and following recognized standards.
- Complexity. Establishing of complex procedures, poorly understood and difficult to execute by operators. Specialist and master’s not involving executers during developing and review of written procedures and instructions.
Conclusion
Without continuous improvement culture your quality program is poor and never evolve. Gets stock in the cost-saving mentality, equipment’s get olds and dirty, state of the art technologies become dinosaurs, employees are not satisfied and motivated, and sooner or later this will be reflected in less compliance, failure, not meeting clients’ expectations -> less sales. A good quality management system requires of processes of continuous improvement truly penetrated in the culture of the organization. Everyone contributing to do the best according to Company priorities. Focusing not only in safety but also in consumer/patients delight.
References
Miller, J. (2013) Creating a Kaizen Culture: Align the Organization, Achieve Breakthrough Results, and Sustain the Gains, McGraw-Hill Education
Chandrasekaran A, Toussaint JS. (2029) Harvard Business Review. Creating a Culture of Continuous Improvement (hbr.org)
Eichfeld A, Golding D, Hamilton D, Robinson K. (2017). Mejora continua – logrando que la buena gestión se convierta en un hábito para los líderes | McKinsey
Meller W. (2017). Os 14 princípios de Deming e o ciclo PDCA (profissionaisti.com.br)
Info-Tech Research Group (2023). Continual Improvement Strategies Can Help Businesses Enhance Productivity and Competitive Edge in Current Economic Climate, Says Info-Tech Research Group (prnewswire.com)
Borris, S. (2008). Lean Manufacturing the Value-Stream Map, and Partial Value; McGrawHill Professional.
Aranda Rodriguez K, Oviedo Gallo DA. (2024). Universidad Peruana de Ciencias Aplicadas (UPC). info:eu-repo/semantics/bachelorThesis: Propuesta de mejora de los procesos de producción, almacenamiento y despacho de una empresa de productos cosméticos e higiene (upc.edu.pe)
Foster M, PDA (2020). FDA Shares Views on ICH Q12, Continuous Improvement and Innovation (pda.org)
02/13/2024. Advanced Manufacturing | FDA
Mazzarisi C, Quality Lead (Quality & Manufacturing Expert) – FDA News Webinar. CGI May 13th, 2020. Pharmaceutical Continuous Quality Improvement (fdanews.com)
Vega G (2021). The Food Tech. Mejora continua: la clave para ahorrar y aumentar la producción de alimentos (thefoodtech.com)
Santiago N. (2018). Calatec. AMFE y Lean Six Sigma para el ISO 22716 de la industria cosmética – Caletec
Beatriz graduated in Biology in the Universidad Central de Venezuela (UCV), PhSc in Physiology and Biophysics by Instituto Venezolano de Investigaciones Científicas (IVIC) – Caracas, Venezuela; and Postdoc in Biophysics at Univ. of Califórnia (UCLA), Los Angeles (USA).
23+ years of work experience in Industry at Procter & Gamble, having global and regional responsibilities in the areas of Industrial Microbiology (R&D and manufacturing), Open Innovation, and quality assurance. Before P&G. worked also in academy and research during 13 years. Teaching experience (3 years) delivering courses for graduate and post-graduate students at UCV and IVIC.
Currently, delivering services as independent consultant in Quality Assurance, Industrial Microbiology, Open Innovation and Coaching at the BMRV Consulting (https://bmrvconsultoria.com/); active member of the Innovation Commitee of ABIHPEC (Brasilian Association of Industries of higiene, personal care, perfumery and cosmetics), and member of the Global Chamber, among others.
