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Processes, building quality into

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. [Pg.467]

Quality Control Building Quality into the Process... [Pg.195]

HPLC analytical specification for I (<8 ppm) was introduced. The sum of detectable contaminant peaks eluting prior to Trp was reduced to <100 ppm and the sum of those eluting after Trp was reduced to <300 ppm. This case, more than any other, has served to reinforce the FDA s position on the vital importance of building quality into process operations. [Pg.112]

These two quality titles are not synonymous, although they are occasionally used indiscriminately. QC can be defined as the function responsible for the maintenance of quality to an agreed standard. QA covers the activities and functions concerned with the attainment of quality, i.e. building quality into processes by broad association with GMP, GLP, etc. [Pg.26]

Process control is defined as taking measures to monitor and, if necessary, adjust processes that lead to the end product. Quality of products can stiU not be guaranteed but a production based on professional standards aims to build quality into every step of the preparation process. [Pg.772]

Cease dependence on mass inspection to achieve quality. Improve the process and build quality into the process in the first place. [Pg.11]

Frequently one will find new citations (not found in the database just completed) in the next bibliographical database that one searches. Are these new citations unique to this second bibliographic database, or were they present in the first database but your search did not find them To build quality control into your search process, return to the first bibliographical database and search for the newfound citations using an author or a title-word search statement. If you do find the newfound citations in the first database, explore the citations index/key words. You may discover additional appropriate search terms or procedures to improve your search. [Pg.786]

Traditional industry paradigm has the Quality Department responsible for quality and the Manufacturing Department responsible for producing product. Inherent conflict exists in this model due to competing functional priorities. By building quality concepts and accountabilities into production processes responsible for production, quality becomes infused into the organization. Both Quality and... [Pg.245]

This section discusses common methods for building quantitative chemometric models in PAC. In this field, the user most often desires to build a model that converts values generated by an analytical instrument into values of properties or concentrations of interest for use in process control, quality control, industrial hygiene, safety, or other value-adding purposes. There are several chemometric techniques that can be used to build quantitative models, each of which has distinct advantages and disadvantages. [Pg.254]

Design Review is a formally documented and structured process of confirming that the LIMS design is both fit for purpose in terms of the requirements of the users/business and also meets regulatory expectations. This is all part of the process of building Quality Assurance into the design. [Pg.524]

The use of color in labeling and packaging is obviously widespread in consumer products and many industrial products. Color is used in such labels primarily because of its emotion-mood related characteristics which can, if effectively integrated into the design of label and package, contribute to the enhancement of attention processes and favorable image building qualities. Obviously, these tend to improve the probability of product trial and brand loyalty development. [Pg.18]

The manufacture of drugs depends on the starting materials, manufacturing processes, building, equipment and personnel involved, it is not sufficient that the finished product passes testing protocols, but quality must be built into the product. [Pg.206]

The BMS and similar systems integrated into the IS architecture provide control and performance monitoring functionality to ensure that performance criteria are met and performance deviations are detected. Functional performance deviations will inevitably affect product quality and, consequently, GxP compliance. It is essential that the design process "builds in quality" to ensure that the system is reliable, consistent and capable of meeting the... [Pg.201]


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See also in sourсe #XX -- [ Pg.11 ]




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