5. From PDCA and PDSA to OODA and beyond
The quality management system is based on the PDCA cycle concept, which is a quality management method used in ISO 9001 and ISO 13485 related to the manufacture of medical devices.
PDCA is a method of continuously improving quality in the order of Plan (plan) → Do (execution) → Check (evaluation) → Act (improvement) → Plan (plan). The PDCA cycle is often from Walter Andrew Shewhart, who advocated statistical quality management, to Schhardt Cycle, and from US statistician William Edwards Deming, Deming Wheel / Deming.・ It may be called a cycle.
There are various theories, but it is said that a Japanese who listened to Mr. Deming's lecture, which was requested to give a lecture on this statistical quality management in Japan, proposed PDCA [i] . It can be said that PDCA originated in Japan.
Through this PDCA cycle, the quality in Japanese industry, especially in the manufacturing industry, has improved dramatically, and "KAIZEN" has been recognized as a Japanese word that can be understood in the world instead of "Improvement". In addition, the quality of the ISO 15883 cleaning and disinfecting equipment, which is an international standard, and the validation and daily monitoring guidelines in the automatic cleaning and hot water disinfection process for medical devices by DGKH, DGSV® / SGSV and AKI compiled based on the standard. A management system must be built and improved, that is, similar to ISO 9001 and ISO 13485, the PDCA cycle is required to build a process for improvement within the organization.
In 1986, Deming said that PDCA “Check” means “to hold back”, so Check cannot lead to the next action. [ii] In 1993, Deming changed "Check" to "Study" and said that "learning" would improve the process of products and services. Plan (plan) → Do (execution) → Study (learning) → Act We proposed (improvement) PDSA. [iii]
However, PDSA has been used as two types of improvement processes as the development of PDCA. Achieving consistent and continuous improvement in the process of products and services Plan → Do → Check → Act → Plan → Do… Used as a spiral flow method to achieve consistent and continuous improvement. , PDSA is Plan → Do → Study → In Act, “Study” means what is obtained by “learning” and affects not only the approach to Act (improvement) but also Plan (plan) and Do (execution). It is said that it is a method of exerting.
PDCA is considered to be effective as an approach to improve effectiveness, efficiency, and safety in a stylized production line, and PDSA uses the data obtained from learning to make a difference between the planning stage and the execution stage. It is an approach to analyze in detail and further analyze the impact on the execution of the improvement system and utilize the results obtained for learning. PDSA is said to be effective for operations that change or change relatively frequently.
Methods using PDCA and PDSA for production control of quality management systems have been recognized and adopted by many organizations, but I hear that this cycle does not actually work or does not work well.
In recent years, research has been conducted on the malfunction of the PDCA and PDSA cycles, and the need for an OODA loop [iv] in addition to PDCA and PDSA has come to be mentioned.
OODA [v] is a loop method in which Feedforward and Feedback exist at each stage of Observe, Orient, Decision, and Act to guide the "best decision". It is advocated as a theory. The transition to each stage of PDCA and PDSA involves individual and organizational decision-making. It is said that this decision-making dysfunction is one of the reasons why the PDCA and PDSA cycles do not work well. The OODA loop theory is especially useful in the context of this decision.
The OODA loop was a theory advocated by John Richard Boyd of the United States Air Force and applied to the concept of the process of military and combat operations. Nowadays, this theory is often used to understand commercial activities and learning processes. This approach has been shown to be effective in reaching the best and quickest decisions to take the agile actions needed to survive, and this theory has become popular and at each stage of PDCA and PDSA. It has begun to be applied to the decision-making process for the transition.
In addition to detailed explanations of each factor and relationship of the OODA loop, it is not the procedures that comply with machines and equipment, ISO and various guidelines, let alone artificial intelligence, but "people" that make "decisions". It is brought about by the group "people".
It is inevitable that PDCA and PDSA, which are the methods for making quality management systems work, and even OODA, which is used for decision-making methods, are caused by the factors (Factors) of "people" and "people." We think that.
At SMP Laboratories Japan Co., Ltd., the quality management system is simply measured for "safety," "effectiveness," "reliability," "efficiency," etc., and its validity is confirmed and verified. The essence of a quality management system through the theme of "medical care" is not to capture the values of patients and their families, interested parties such as medical institutions and life-related companies, but also the values of individuals and the social values that change with the times. We provide education and training on how we can share and accept.
[i] “History of statistical management methods”. Union of Japanese Scientists and Engineers. Http://www.juse.or.jp/statistical/history/ (Refer to statistical management methods)
[ii] Deming, WE 1986.Out of the Crisis. MIT Press. Cambridge, MA, p88.
[iii] Deming, WE 1993.The New Economics. MIT Press. Cambridge, MA. P135.
[iv] Boyd, John R.1976. Destruction and Creation (PDF). US Army Command and General Staff College.
[v] Kent B.2018. Observe, Orient, Decide, Act: A Subjectivist Model of Entrepreneurial Decision Making. JOURNAL OF MANAGERIAL ISSUES Vol. XXX. P349.