Quality control improvement cycle

The major problem for control based on material states, however, is the quality control culture that requires that parts be accepted based on adherence to a preset cycle within specified limits. Because state-based inferential control systems could theoretically come up with a new cure cycle every time, this sort of specification cannot be used with such systems. Specifications instead have to be in terms of the process plan used for the cure. The satisfactory completion of a certain cure history without alarm states would be assumed to produce an acceptable part. Once the culture was able to accept that difference for autoclave curing, production costs at the U.S. air force s McClellan AFB Logistic Center were substantially reduced [32], This type of specification could also give material review boards a head start on investigations because they would know that a part did not meet specification as well as what sorts of flaws might result from the deviation. The experience at McClellan is that there are fewer parts to review. It is even conceivable that, with improvements to sensors, much of the current postcure nondestructive evaluation used to verily the quality of parts could be incorporated into the process, building quality in rather than inspecting it in after the fact. 

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... 

A quality management system (QMS) is an important tool for process control and continual improvement. After a brief section about development of the quality principle in the preparation of medicines over the years, this chapter lists the processes in preparation and in the manufacture of medicines that have to be controlled. A medicine, whether developed in a pharmacy or in industry, starts with defining the needs of the patient. Then the formulation and the method of preparation are designed to meet product specifications. The next step of the product life cycle is the production, including quality control and release. 

At the core of these elements is the simple concept of a PDCA methodology, called the Shewhart cycle (Shewhart, 1931), that can equally be applied to all safety management systems. PDCA has been at the root of quality control and safety programs. The Shewhart cycle has been adapted within the framework of many voluntary compliance standards such as ANSI ZlO-2012 Occupational Safety Process (Occupational Health and Safety Systems, 2012). Refer to Figure 6.1, Shewhart, PDCA Cycle for Learning and Improvement . 

The controlled driving cycles allow manufactnrers to gain quality performance and operation feedback that will enable further system improvement. 

With thermoplastics the main purpose of the mould system is to minimise both the cycle time and thermal differences in mould part cooling. Mould cooling is therefore essential for both cost saving and quality control. Uniform cooling improves product quality by preventing differential shrinkage, high residual stress and mould release problems. 

Risk-based orientation Regulatory scrutiny based on the level of scientific understanding Mechanistic basis for understanding failure modes and variability Sources of variability and risk to quality Drive out fear Continuous improvement— Change control and life cycle management... 

As discussed in section Continuous Improvement—Change Control and Life Cycle Management. Change towards continuous improvement should be encouraged. Quality by design and process understanding can... 

Life cycle management and change control provide a mechanism for continuous improvement. To support continuous improvement through change control a quality system would need to be based on principles of manufacturing science and risk-management. The proposed ICH QIO guidance is an opportunity to accomplish this task. 

A quality management system s process should follow a standard Six Sigma process improvement life cycle that includes the following steps define (process and metrics), measure and control (identify problems and issues), analyze (analyze problems and issues), and improve (implement) circling back to measure and control [11]. An example of a process improvement life cycle can be seen in Figure 9. 

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