Standard Operating Procedure concept

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

The starting point for the development of automation concepts was in analytical routine laboratories (e.g. analytical R D and quality control) dealing with high numbers of samples routinely to be analyzed by the application of standardized operation procedures [349]. In parallel, the first robot systems for research were developed and these combine the key technology of liquid handling with the movement of items through a defined space. 

Considerations of overall data quality assurance include, data quality, data quality control, standard operating procedures (SOP), good laboratory practices (GLP), and concepts of accuracy, precision, and reliability. Also included are reference methods, standard methods, referee methods, official methods (from organizations or in-depth individual studies), and high-reliability methods. 

Lilly used the PSAP concept for analytical plaiming only, without details around data collection, as Lilly already had a standard operating procedure (SOP) in place for a product-level data collection plan. Lilly s format of the PSAP is very similar to an SCS SAP and contains the following sections ... 

In Production At this stage, kaizen—continual improvement—is the governing concept. Superior quality is maintained. Adherence to standard operating procedures, including safe practices, is the norm. Waste is constantly searched for and eliminated. 

Process Detailed Design Detailed specification based on concept design Minimize number of possible leak paths Make plant friendly to control, operate, and maintain Avoid or simplify hazardous activities such as sampling, loading and unloading Process conceptual design and codes/standards and procedures Experience on past projects/designs... 

Design concepts were used to minimize hazards to personnel, to prevent corrosion, and to protect the environment. Special operating procedures, personnel safety equipment, and training completed these design concepts. An extensive ambient-air monitoring network was established to insure that ambient-air standards were met to protect the environment. 

OSHA s standard requires that The employer shall establish written procedures to manage changes— The principle involved here is important and is having its impact far beyond chemical companies. What is required is that hazards be identified and evaluated when changes are made in design criteria, operations, procedures, and facilities. That s a good thing to do, and I recommend a broad application of the principle. It is a concept that can be applied in all businesses and industries, as the top performers have learned. 

For the operation related information, concepts for operating procedures, operating conditions, and parameters are necessary. The hierarchical level of ISA-S88.01 standard (ANSI/ISA-S88.01, 1995), which decomposes a process into different levels, namely procedure, unit procedure, operation, and phase, has been followed in this work. To specify a piece of operating procedure, parameters and operating conditions are needed. Definition of process chemistry is straightforward and can be divided into reaction and... 

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