Continuous quality performance

In Section IV we considered a categorical performance metric y. Although that represents a common practice, especially when y defines the quality of a product or process operation, there are many instances where system performance is measured by a continuous variable. Even when y is quality-related, it is becoming increasingly clear that explicit continuous quality cost models should be adopted and replace evaluations of performance based on categorical variables. 

Self-assessment Self-assessment can help an organization to learn about its own strengths and weaknesses. Transforming a DRA into a learning organization which routinely conducts self-assessment and continuous quality improvement can be a powerful approach to enhancing dmg regulatory performance. 

It is always recommended that OQ is carried out after a service visit. Evidence of continued satisfactory performance during use (PQ) should be obtained from everyday method-related checks (e.g. system suitability testing, calibration and analytical quality control). It is advisable to set up thresholds outside of which the performance of an instrument is no longer acceptable. Each stage of the equipment qualification needs to be fully documented so that the evidence of performance at any given time can be checked. 

Reliability and availability Does the running system reliably continue to perform correctly over extended periods of time What proportion of time is the system up and running In the presence of failure, does it degrade gracefully rather than shut down completely Reliability is measured as the mean time to system failure availability is the proportion of time the system is functioning. Both qualities are typically dealt with by making the architecture fault-tolerant using duplicated hardware and software resources. 

A modified Youden two sample quality control scheme is used to provide continuous analytical performance surveillance. The basic technique described by other workers has been extended to fully exploit the graphical identification of control plot patterns. Seven fundamental plot patterns have been identified. Simulated data were generated to illustrate the basic patterns in the systematic error that have been observed in actual laboratory situations. Once identified, patterns in the quality control plots can be used to assist in the diagnosis of a problem. Patterns of behavior in the systematic error contribution are more frequent and easy to diagnose. However, pattern complications in both error domains are observed. This paper will describe how patterns in the quality control plots assist interpretation of quality control data. 

Quality assessment programs must foster and support continuous improvement and quality performance. 

With the use of microprocess technology, the fluorination with DAST can be performed under decomposition conditions in continuous-flow mode [50], Temperatures of 90-100 °C and reaction times of 60-120 min are necessary for high conversions in order to compensate for the slow intrinsic reaction rate. A continuous quality control allows regulation of the process parameters (PAT, process analytical technology). A throughput of 5-10kg/day using three parallel modules was achieved. 

With continuing new developments in equipment (and plastics) their quality performance and output rate improves and overhead costs are reduced. Result has been the industry worldwide continues to be more productive even though the economy has its ups and downs.135 136 248... 

Specification tests are perfomied on plant streams once or twice per worker shift, or even more often if necessary, to assure the continuing quality of the product. The tests are also performed on a sample from an outgoing shipment, and a sample of the shipment is usually retained for checking on possible subsequent contamination. Tests on specialty types of acetone may require sophisticated instruments, eg, mass spectrometry for isotopically labeled acetone. 

In any laboratory, a number of routine checks are performed to ensure continuing correct performance. Under a quality system, one very important... 

Level 5 Continually improving performance benefits on successive projects in terms of costs, schedule, and quality. Of issues raised, 100% are resolved. Teams are cohesive and seamless. Level 5 organizations typically are specialized into niche expertise. 

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. 

MacKinnon, N.J. Hepler, C.D. Bennett, L. Performance Indicators for Continuous Quality Improvement in Pharmacy (PICQIP) A Study Update. In American Pharmaceutical Association Annual Meeting, San Antonio, TX Mar. 1999 Posey, L.M., Ed. (Presentation abstract). 

The precision of a determination is defined as the concordance of a series of measurements of the same quantity (V3). The definition of precision includes the terms repeatability and reproducibility (Hll). Repeatability is a measure of the deviation of test results from their mean value, all determinations being carried out by one operator and without change of apparatus, where apparatus can be significant (Hll). For reproducibility in clinical chemistry the definition provided by Hughes (Hll) is not entirely satisfactory, and an alternative is proposed as follows reproducibility of a method is a measure of deviation of test results from their mean value, the determinations being carried out over a period of weeks or months, perhaps by different operators, the operators in no case knowing the identity of the analytical specimens that are being used to assess the continued quality of performance of the technique. 

Continuous quality measures should be in place for any laboratory performing EIER2 testing. 

Within a company, QC action is directed at three areas raw material control, process control, and finished product control. The approach in setting up a system will be very similar in each case, i.e. design into the operation all the parameters that will bear on the manufacture of quality, followed by a means of establishing that conformance has been achieved. (An important element of this is the continuing revalidation that processes continue to perform as specified.)... 

Once a method has been validated, an important aspect of applying it is to assure that it is working properly. Quality assurance (QA) is the implementation of procedures to ensure and document that the method continues to perform as required and is part of the responsibility of the quality assurance unit. It includes written documentation of validation of the method, procedures followed, and the sample custody chain. A number of quality control procedures are implemented, based on quantitative measurements. Typical quality control activities are listed below. 

Similar to Robert Pirsig s hypothesis of Zen and the art of motorcycle maintenance [1], a mental exercise is at the heart of managing a perfect laboratory . The mind needs to be prepared to perform a flawless analysis and whatever is required to make it so otherwise a perfect analysis is simply not possible. Determination to excel, mental discipline to stay the course, willingness to overcome inertia and resistance of others, and focus on producing perfect analysis at all levels of laboratory staff are essential. Improvement in laboratory quality performance is a process, not a project. A project ends, but a process continues. 

Infrastructure and Conditions Suitable to Perform the Analyses. The laboratory, equipment, and instrumentation must be suitable for the purpose and properly maintained and calibrated, and the analytical methods used must be validated as fit for purpose and under continuous quality control. 

Information on specific production methods can be found in the literature [Pinna 1998]. Impregnated catalysts are mainly produced batchwise with discontinuous process steps. Therefore, continuous quality control of the individual catalyst batches is vital (e.g., testing of mechanical strength, performance tests in screening reactors). The process developer must pay special attention to transferring the laboratory recipe to industrial catalyst production. Test production should be carried out relatively early... 

The swap yield curve is correlated with the Treasury yield curves, but this correlation has decreased from 2001 to 2002. This may be explained by the increase in the investors risk aversion as continuing poor performance of equity markets in 2002 has triggered a search for liquidity and quality. The correlation with the Treasury yield curves is high for the first factor (see Exhibit 24.4), but weak for the second and third factors (see Exhibits 24.5 and 24.6). 

Methods to achieve product quality are identical in most respects with the methods used to achieve superior results in safety. Also, the processes addressed in a continuous improvement initiative to minimize product defects are the same processes in which injuries, illnesses, and environmental incidents occur. Is the practice of safety, as suggested by Dr. Thomas A. Selders, simply another means of achieving quality performance ... 

X You cannot put a price tag on a quality employee or on continued superior performance. Money is a poor form of recognition. 

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