Approaches to quality improvement

Hahn. G.J., and Boardman, T.J. (1987b), Statistical Approaches to Quality Improvement Part 2, CHEMTECH, 17, 412- 17. 

A typical illustration of a PAT approach to quality improvement is the use of near-infrared spectroscopy (NIRS) to qualify excipients and active principles just before they enter the production process, for example, in dispensing. As discussed in the next part, near-infrared (NIR) spectra are informative about product structure and overall quality. Because with substances such as excipients the quality range was investigated at some time in the past and fixed into a calibration, NIR measurement can provide simultaneous nondestructive confirmation of the predominant physical and chemical parameters. This is an effective method of reducing uncertainties about possible causes of failure or poor quality during production. Each time a given excipient fails its quality requirements at the moment of use, immediate action can be taken. Control is possible before the risk of failure is increased. Such an approach is complementary to container-wise identification of materials on delivery to a warehouse. 

The model assumes that the random causes are inherent in the current process and it is usually uneconomical to investigate and eliminate these variations within the confines of current technology. However, the assignable causes are external to the current process, and it is usually economical to intensively search for and eliminate the root causes and, thus, effectively optimize the application of the current technology. Hence, the approach to quality improvement is the separation of the variations internal to the process from those that are external to the process. 

Total quality management—A term coined to describe Japanese-style management approaches to quality improvement. Since then, total quality management (TQM) has taken on many meanings. Simply put, TQM is a management approach to long-term success through customer satisfaction. TQM is based on the participation of... 

We found that the following principles were key to the successful implementation of an OBMod approach to quality improvement in a continuous process production environment ... 

Open acknowledgement that an OBMod approach to quality improvement must be regarded as a process not a project. 

Feedback of the results of the opinion survey, to all personnel, provides an opportunity to sow the seed of commitment to a behaviour-based approach to quality improvement. It also signals management commitment to the importance placed on quality and the need for quality improvement, and provides a forum in which to exchange suggestions and ideas. In essence, it can facilitate the process of employee involvement and empowerment (McAfee and Wirm, 1989). 

Quality consists of two elements quality of conformance (have we met specifications ) and quality of design (are the specifications correct ). In the case of the behaviour-based approach, such specifications are expressed in terms of specific, observable and measurablebehaviours.Ratherthan being a somewhat abstract truism, quality is, in effect, defined for sub-units of the overall process in terms of specific units of behaviour. The previous use of this approach for safety improvement suggests that it would work equally well for quality of conformance. Quality of design, however, is dependent on increasing levels of inter-departmental communication and the establishment of an internal quality model. Therefore, the approach should facilitate both a team model and an internal customer approach to quality improvement. Before this structure is discussed in detail, it is important to consider the issue of gaining commitment to a quality improvement process. 

An understanding of the behaviour-based approach to quality improvement and the strategies used. 

When using the defect-detection approach to quality control certain problems develop. Inspection does nothing to improve the process and is not very good at sorting good-from-bad. Also, sampling plans developed to support an acceptable quality level (AQL) of 5%, for example, say that a company is content to deliver or reject 5% defects. 

Dettmer HW. Goldratt s theory of constraints a systems approach to continuous improvement. ASQ Quality Press, 1997. 

Recognizing these developments, the editors of this volume organized a symposium to discuss recent advances in molecular approaches to the improvement of food quality. A particular strength of the symposium, and of this book, is the international participation and the presentation of a variety of new and exciting developments in food science. 

This Chapter describes outlines and discusses the regulations applicable to the QA function and unit, structure, function, charter, and application of the unit in the pharmaceutical manufacturing environment. In addition, it discusses additional quality-related responsibilities that may result when manufacturers move toward a quality systems approach to quality that incorporates current quality system models to further improve quality and harmonize with international quality system requirements. 

Improvement of the organization s approach to quality, based, in part, on the feedback report. 

Jencks, S.F. Wilensky, G.R. The health care quality improvement initiative. A new approach to quality assurance in medicare. JAMA, J. Am. Med. Assoc. 1992, 268 (7), 900-903. 

Dettmer, H. W. (1997), Goldratt s Theory of Constraints A Systems Approach to Continuous Improvement, ASQC Quality Press, Milwaukee. 

This is key when using this family of metrics. When customer expectations are unknown or poorly defined, they cannot be intentionally achieved. You cannot set or achieve goals related to aspects of performance that you cannot even define. The approach to quality and continuous improvement reviewed above therefore, emphasizes the need to let the customer define quality, to consider any deviation from that a defect, and to set specific goals about reducing defects on a continual basis. 

Dr. Joseph M. Juran later emphasized a more strategy- and planning-oriented approach to quality. He proposed quality planning, control, and improvement as three highly interrelated processes. The Juran Institute is still an active organization promoting the Juran philosophy and quality improvement practices. In the 1980s,... 

Facilitates benchmarking, drives continuous improvement, encourages employees involvement and ownership, provides visibility in direction, raises understanding and awareness of quality related issues, develops a common approach to continuous improvement across the company. 

Six Sigma is a philosophy relating to defects based on a normal distribution but has become synonymous with the development of structured approach to the improvement of organisational systems and processes, using total quality management techniques. Staff can be trained as black belt facilitators of the six sigma approach. 

Sessions to anticipate and solve potential problems in the application of the behaviour-based approach, and to identify the facilitators and barriers to quality improvement. 

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