Quality assurance history

This book marks the conclusion of this strong period of development and is therefore a milestone in measurement science. As such, the field already has a history. But as history makes no sense without a future, the last Chapter of this book deals with expected further developments in terms of organization and needs. Between history and future the book presents, as a snap shot, the application of standards in analytical chemistry. The perspective of Quality Assurance is never forgotten. 

Analytical laboratories, especially quality assurance laboratories, will often maintain graphical records of statistical control so that scientists and technicians can note the history of the device, procedure, process, or method at a glance. The graphical record is called a control chart and is maintained on a regular basis, such as daily. It is a graph of the numerical value on the y-axis vs. the date on the x-axis. The chart is characterized by five horizontal lines designating the five numerical values that are important for statistical control. One is the value that is 3 standard deviations from the most desirable value on the positive side. Another is the value that is 3 standard deviations from the most desirable value on the negative side. These represent those values that are expected to occur only less than 0.3% of the time. These two numerical values are called the action limits because one point outside these limits is cause for action to be taken. 

History of company andproduct. Note that level of development staffing. Software development (SW Dev) and quality Assurance manual Describe purpose. For example, is it intended to facilitate validation by... 

Sample preparation involves physical and chemical treatments which are potential sources of bias, variance, contamination, and mechanical loss. Sample preparation should be planned carefully and documented in sufficient detail to provide a complete record of the sample history. Furthermore, samples taken specifically to test the quality assurance system should be subjected to the same preparation steps as the test sample. 

Quality assurance departments that demonstrate a history of effectiveness within the corporate culture and foster loyalty among their peers are usually known for fairness, constructive approach, cooperative attitude and informative style. 

Good documentation constitutes an essential part of the quality assurance system. As claimed in the European Community (EC) Guide to Good Manufacturing Practice (GMP), Chapter 4 Clearly written documentation prevents errors from spoken communications and permits tracing of batch history. In general, the requirements for documentation related to manufacturing of pharmaceuticals, as set in the GMP... 

The author has briefly recounted the history of scientific interest in precipitation chemistry and focused attention on some of the important problems dealing with the quality assurance of analyzed samples. These considerations lead the author to conclude that comparisons between data collected prior to the late 1970 s and those... 

Due to the variety of potential sources of used lubricants, their differing histories of service use and their subsequent levels of possible contaminants, assessment of the quality of the resulting re-refined base oil is a major concern. Quality assurance must be applied both to the used lubricant feedstock and, more particularly, to the product(s) of the re-refining process. Limits to the concentration of various contaminants in the finished base oil must be set and strictly adhered to. 

N.S. has been asked to help in this regard. We have a sample from them. It is a blind sample in that we do not know the history, i.e., we do not know if it is a regular quality assurance sample, whether it is one for which the expiration date has passed, or whether it is one for which they have received a customer complaint. Thus, we cannot make any judgment about the sample — only report the results. It is labeled as a 1000 ppm copper solution. 

Contents include definitions, study planning, quality assurance and control and data quality assessment, sample acquisition, and requirements for analytical laboratories. Appendices cover a hypothetical case history for drum characterization and a survey of statistical techniques. 

The implementation of pharmaceutical care is supported by data collection and documentation systems that accommodate patient care communications (e.g., patient contact notes, medical/medication history), interprofessional communications (e.g., physician communication, pharmacist to pharmacist communication), quality assurance (e.g., patient outcomes assessment, patient care protocols), and research (e.g., data for pharmacoepidemiology, etc.). Documentation systems are vital for reimbursement considerations. 

Principle. Good documentation is an essential part of the quality assurance system and, as such, should be related to all aspects of GMP. Its aims are to define the specifications for all materials and methods of manufacture and control, to ensure that all personnel concerned with manufacture know what to do and when to do it, to ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale, and to provide an audit trail that will permit investigation of the history of any suspected defective batch. The design and use of documents depend upon the manufacturer. In some cases some or all of the documents described below may be brought together, but they will usually be separate. 

Principles Every system of quality control requires documentation in order to dispose over ail data serving as the basis for production, packaging and quality assurance and in order to record the history of a lot. 

Documentation is an essential part of the Quality Assurance system. Its purposes are to define the system of control, to reduce the risk of error inherent in purely oral communication, to ensure that personnel are instructed in the details of, and follow, the procedures concerned, and to permit investigation and tracing of defective products. The system of documentation should be such that the history of each batch of product, including the utilisation and disposal of starting materials, packaging materials and intermediate, bulk and finished products, may be determined. 

When attempting to assess the biogeochemical pathways and health impact of metals it is crucial to determine the total concentration accurately and where possible to identify and quantify the physical and chemical forms, or species. The analytical determination of metals in sea water has had a difficult history and many measurements reported in the literature prior to about 1985 should be treated with caution. Major strides have been made in the minimization of contamination during sample collection, storage, and preparation and in the application of sensitive analytical techniques, sometimes coupled with methods for the separation of metal species. The concentrations of dissolved metals have been revised downwards in recent years as a consequence of the introduction of these advances, together with improvements in analytical quality assurance, including appropriate use of certified reference materials. 

Fig. 3-11. This poster from World War I was designed to encourage enthusiasm for quality assurance among women who worked manufacturing protective masks. Photograph Courtesy of Pictorial History, Gas Defense Division, Chemical Warfare Service, Vol 5, Edgewood Historical Files. Held at Chemical and Biological Defense Command Historical Research and Response Team, Aberdeen Proving Ground, Md.

The MS I group should be required by an administrative procedure to select records which provide a meaningful history of the plant and to retain them throughout the plant s lifetime. Other records that have only a transitory value (such as records on individual components that have been replaced) should be retained either until they cease to serve the purpose for which they were intended or until they are superseded by subsequent records. An important factor that should be considered in selecting records to be retained is their usefulness in assembling reliability data. More information on the retention of records necessary for quality assurance purposes can be found in Ref. [2], in particular in Safety Guide Q3 on Document Control and Records. 

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