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How to Implement the Continuous Improvement Cycle in Regulated Industries


Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ingredients for a great organizational culture or a superior product, the public generally understands that a company or department is not likely to have everything perfected at the outset. However, in the pharma and healthcare industries, a lower tolerance for error exists because mistakes have a greater potential of being damaging to human life. To err is human, but as The Institute of Medicine insisted in its standard-setting report that drew attention to quality control in the healthcare sector: improving the healthcare system requires constant critical attention to the function of the system itself, always with an eye to intervention and improvement. 


What exactly is the continuous improvement concept?

Continuous improvement is a quality management concept that the best businesses utilize to keep their products and employment teams at the peak of good shape with respect to quality, cooperation, performance, and engagement. The pharma and healthcare industries derive potentially large benefits from adopting a continuous improvement model that seeks gradual increases in quality over time and often even achieves breakthrough levels of improvement within shorter periods. 

Generally, in the business world, a few quality management models exist via which a company, its managers, and its employees can actively pursue continuous improvement cycles to set goals and achieve the levels of progress that will realize those goals in an appreciable timeframe. The PDCA is representative of these models, and they achieve positive results. What it has in common with the other models is the determination of the team to assess its strengths and shortcomings, set goals to attain improvements, and persevere with the intervention (or alter it, if necessary), until the desired change occurs. 


The PDCA model

PDCA—the Plan-Do-Check-Act Model—involves identifying a problem in the organizational setting and proceeds by:

  • Devising an initial plan to improve the conditions. This means collecting all data that pertains to the issue and then testing hypotheses to determine the root causes. 

  • Implementing that plan—doing what has been proposed as a likely solution. This implementation is a test of the proposed solution and during this stage the team measures the results to gauge the effectiveness of the intervention. 

  • Checking the data, a task that requires a before-and-after comparison of the group’s (or product’s) performance since the intervention. At this stage, the group or manager decides whether the initial assessment and hypothesis about how to improve was actually a workable one for the situation. 

  • Action: the activity that follows this is the documentation of the results—creating a record of whether the proposed solution actually solved the problem—and a recommendation for future action regarding the situation. So, if the tested plan works, it gets implemented throughout the organization and if it doesn’t work, it gets adjusted and the continuous improvement cycle is re-entered. 


Circle graph of PDCA, continuous improvement cycle | Scilife



Expanding PDCA to OPDCA

A more scientific formulation of PDCA adds an observation stage prior to the other phases. This updated OPDCA model is useful for the advancement not just of quality but also of intelligence, sustainability, and performance goals. Managers using this model spend time learning and understanding the environment by observing how things are meant to occur as well as the deviations that might cause hiccups within the system. Since the health sector is founded upon the scientific method, the extension of the system to include observation is particularly pertinent to the industry. Accurate observation leads naturally into the other stages—it is, in fact, implicit in the PDCA system. For in order to collect the data necessary to devise a plan (or hypothesis), observation must be performed first. At this point, the quality cycle continues through the doing, checking, and action phases, as described above. 

Recent research has shown that the healthcare and pharmaceutical sectors need to support their regular systems of quality assurance with continuous improvement methods in ways that allow employees and managers alike “to address complex issues, like the improvement of clinical care processes” (Mazzocato et al., 2016). This focus on processes rather than the individual demonstrates the importance of examining systems’ functioning and the engineering of solutions at the operational level. 


Nonconformity as the driver

One surprising but the key factor that supports continuous improvement is the existence of deviations, complaints, and instances of nonconformity within the processes of the organization. The term nonconformity is used when performing quality audits to designate that a system, product, or process fails to meet all the standards or specifications as set forth in its charter or objectives. In the health industry, this may refer to instances within the system in which patients feel less than secure—whether as a result of medications prescribed, privacy breaches, or physical dangers of the facility. 


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as the driver for continuous improvement


Problems versus opportunities

Whenever clients, patients, or employees file complaints or such nonconformity is otherwise shown to exist, rather than consider it a failure of the system, managers and quality control specialists should view it as an opportunity to adjust the system so that it attains its optimal performance capabilities. In preparing a performance report in order to log such problems, the document should be composed with the continuous improvement cycle in mind and not just as an incident or error log. Therefore, documenters should consider not only the instance of deviation or nonconformity that took place but also the circumstances that supported that deviation in order to examine conditions within the system itself that might make such aberrations likely to happen in the future. 

Nonconformity assessment and documentation with a focus on the system provides a better method of gauging the full scope of a problem rather than focusing solely on a problem that might be just a symptom. Reviews by management and employees as well as internal audits and client feedback provide ways of performing thorough quality assessments of nonconformity from a variety of angles to ascertain root causes. Since the identification of root causes is the first step in the cycle of continuous improvement, no management team can afford to omit or remove the analysis of nonconformity from its set of continuous improvement tools.



In the medical industry, continuous improvement cycles provide a significant benefit to its users, as these improvements can be measured in terms of quality of life. Developing a problem-solving focus in the execution of actions related to product development or services creates opportunities for increased efficiency. A manager dedicated to this processual and incremental improvement gets the best out of any situation, including instances of nonconformity. To such a manager, instances of deviation are opportunities for refining the process and making it even safer, more efficient, and more satisfying to the company's clients, employees, stakeholders, and the public at large.

The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to...