Quality Improvement Cycle

Provide continuous quality improvement training to all employees 

Make an unrelenting commitment to quality and involve all levels in the organization 

The first step in the improvement cycle is to increase current knowledge of the process. The more the team knows about the process, the more likely it is that changes submitted by the team will improve quality. Phase 1 takes a significant amount of time to complete. The planning phase should address specific objectives and questions, make predictions, and propose a plan fortesting. At the conclusion of Phase 1, the plan that is developed should consider methods, resources, schedules, and people. 

Phase 2 implements the data collection process. The data collected is used to address the questions from Phase 1. Data analysis can reveal what is actually happening, and lead to refinement 

This phase combines Phase 1 and Phase 2 activities. The results of the data analysis are compared to current knowledge and theories to see if contradictions exist. 

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Explain the four phases of the quality improvement cycle (plan, observe and analyze, learn, and act). 

The key fxmctions of the CRO industry include improving cycle time, increasing quality and lowering the cost of therapeutic product development. A critical element of that process is the adophon of computer-based electronic enhancements (IT applied to the product development segment of the research and development continuum). Compared... 

Planning quality improvement, implementing the plan, analysing the results and re-plamung is a continuous cycle (Plan-Do-Check-Act). Interrelated improvement plans are deployed at all levels of the laboratoiy (corporate, department, process, individual). It is essential to note that the commitment of laboratory personnel is maximized when such personnel is actively involved in the generation and deployment of the improvement plans. 

Improved cycles were developed to increase the efficiencies of PSA systems. The innovation consisted of withdrawing product-quality gas from an adsorber that has completed its adsorption step by depressurizing the bed cocurrently, in the direction of feed and product flow, to some intermediate pressure. By control of the mass-transfer fronts of the impurities, the purity of this lower-pressure gas is maintained at... 

Third, small changes should be implemented in quick cycles (Hume, 1999). The quality improvement team should be given the opportunity to learn about quality by attempting small changes at first. It may be too frustrating for them to take on a large project for the first cycle. Team members should be allowed to experience a success and see how much improvement can be made with a relatively small change then their enthusiasm will redouble. 

Focused or targeted medication use evaluation follows a reasonably well-established cycle identification of a potential problem in the use of a specific drug or therapy, collection and comparison of data, determination of compliance with a pre-established guideline/expectation, and action as needed to improve discrepancies between expected and measured results. This type of medication use evaluation provides an excellent opportunity to apply the Shewhart cycle for continuous quality improvement (Figure 26.3). Focused medication use projects are typically selected for a specific reason. Table 26.4 lists reasons to consider drugs for focused evaluation projects. 

A diagram of the quality planning process is shown in Fig. 4. This planning process represents the first four steps in the continuous improvement cycle (Fig. 5), discussed in the section The Quality Improvement Process. ... 

The link between quality planning and quality improvement is execution. The continuous improvement cycle (Fig. 5) starts with benchmarking and internal assessment to arrive at a gap analysis. From the gap analysis an action plan with assigned leadership, resources, timelines, and metrics is developed. From this quality plan, the plant s human resources must successfully execute the plan for improvement to occur. It is the leadership s responsibility to assure that the plan is do-able, appropriate and adequate resources are assigned, and that the culture of the plant supports change. This starts with the project leaders who must have not only the technical skills, but also the project... 

Four principles construct a planning and design framework in an effort to value natural capital and consider true environmental impact.1 Each of these four principles is powerful enough alone to impact an organization s progression toward sustainability, but the greatest impact is when these principles are adopted as a complete framework. Additionally, the principles will be presented linearly, but are best used as a circuitous framework, similar to the quality improvement framework of the Deming Cycle Plan, Do, Check, Act.2... 

Pharmaceutical outcome data are also used to improve the quality of care, identify potential problems, and improve patient outcomes. These data are often used within a continuous quality improvement (CQI) cycle, where rate-based performance measures are tracked over time and used in conjunction with control charts to show changes in quality and assess the impact of programs or changes in process. Information can be fed back to front line health care practitioners, areas for possible improvement identified, appropriate changes made, and reassessments initiated. 

This is a four-step process for quality improvement that is sometimes referred to as the Deming cycle (Figure 54.6). One of the consistent requirements of the cycle is the long-term commitment required. The Shewhart cycle or PDCA cycle is outlined here and has had overwhelming success when used properly. It is also a very handy tool to use in understanding the quality-cycle process. The results of the cycle are studied to determine what was learned, what can be predicted, and appropriate changes to be implemented. 

Not lower than 85°C (185°F). Mold filling and article quality improve with increasing temperature. High mold temperature increases cycle time only marginally, as the glass transition temperature is at 145°C (293°F). Pre-drying... 

The process becomes one of never ending quality improvement and Figure 18.16 shows a typical cycle of improvement. 

Figure 18.16 Cycle of never-ending quality improvement.

The Deming cycle entails make a plan for an improvement, do it, check whether the desired result is obtained, and act from now on in this way. Continuous monitoring of the result, if necessary followed by (further) adjustment, allows for a structured quality improvement. In the pharmaceutical area a QMS (PQS) is also necessary for the demonstration of compliance with regulatory requirements and professional standards. Thus, the Ph. Eur. monograph Pharmaceutical Preparations (see Sect. 35.5.3) states Manufacture/prepa-ration must take place within the framework of a suitable... 

Fig. 35.1 Deming s circle or PDCA-cycle for quality improvement...

The writers of ANSI7AIHA ZlO-2005, the Occupational Health and Safety Management Systems (OHSMS) Standard, emphasized that the OHSMS continual improvement cycle [is] based on the recognized quality concept of Plan-Do-Check-Act (PDCA). A depiction of the PDCA concept appears at the beginning of each of the Scope, Purpose, Application, and Definitions sections. Figure 1 duplicates that depiction. 

Deming s original depiction of The Shewhart Cycle is a six-step, numerically identified process in which the words plan, do, check, and act do not appear boldly as in later PDCA depictions. These are the six steps. Keep in mind that this is a quality improvement process ... 

They could also be organized by solution type. Examples would be systems, production technology, or organization development and skills enhancement. Another alternative for sorting is by end result. Examples include cost reduction, cycle time reduction, quality improvement, or revenue enhancement. A "six sigma" program is an example of an end result approach. Another alternative set of initiatives might be our five tasks for SCM. 

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