Quality assurance efforts

Monitoring programs must have their own quality assurance programs. These may be called project quality assurance plans or protocols for specific purposes O). If reliable vendors of services are used, the bulk of the quality assurance effort can be placed on those activities unique to the program. Without reliable vendors, QA efforts will be ineffective since it is not cost effective to police quality assurance practices at all lower levels nor to screen all data for its validity. 

Over the past decade, a major trend has been the development of the use of proficiency testing (PT) or evaluation materials (Fox 2000). PT materials are a type of reference material, which aid in assessment of analytical laboratory measurement quality. There will be an increased use of such materials as part of laboratory accreditation programs and other new quality assurance efforts, including internal audits. At the same time, a number of providers have used PT schemes to produce a form of RM intended to meet the ever-growing need for RMs required for routine QC use (Jenks 1995,1997). 

No health system in the world have unlimited access to all medicines. Rational selection of essential medicines is one of the core principles of national medicines policy. It focuses on therapeutic decisions, professional training, public information, financing, supply and quality assurance efforts on... 

Quality assurance efforts within this phase will focus on four types of studies conducted for safety evaluation (a) safety studies on regulated products, (b) safety studies that encompass the full scope of laboratory operations, (c) studies that are significant to safety assessment, e.g., carcinogenicity, reproduction, chronic toxicity studies, and (d) studies that encompass operations for several species of animals. 

Pharmacists should be involved in all steps of pain management. This includes the initial development of pain management policies and procedures development of standardized pain assessment and documentation forms development of standardized treatment orders, including recommendations to manage adverse effects education of staff on the implementation of the new pain management standards and quality assurance efforts to evaluate the policies and procedures. 

From a historical perspective, with the introduction of univariate control charts by Walter A. Shewhart [267] of Bell Labs, the statistical quality control (SQC) has become an essential element of quality assurance efforts in the manufacturing industry. It was W.E. Deming who championed Shew-hart s use of statistical measures for quality monitoring and established a series of quality management principles that resulted in substantial business improvements both in Japan and the U.S. [52]. 

Pacemakers are among the most reliable electronic devices ever built device survival probabilities of 99.9% (excluding normal battery depletion) at 10 years are not unheard of. But despite intensive quality assurance efforts by manufacturers, the devices do remain subject to occasional failures the annual pacemaker replacement rate due to generator malfunction has been estimated at roughly one per 1000 devices implanted, a marked improvement in reliability since the early 1980s (Maisel et al. 2006 Maisel 2006). There have been multiple major advisories and recalls issued by the FDA regarding pacing leads, with more of these because of problems with the lead insulation than with the lead conductor. 

Specific product and process characteristics identified Certain features of the component will affect performance more than other features. Called "key" characteristics, these are the focus of quality assurance efforts. 

Contractual agreements with major OEMs often require that the material under transaction meet the specifications set forth by the OEM for the incoming material, as part of the quality assurance effort. The resin supplier is required to demonstrate that the shipped material is within the specification. The testing involved is dependent on the OEM and targeted application, to provide proof of compliance. 

Our quality assurance effort on H-VAD software consists of two parts code coverage measurement in in-vitro environment using blood-like liquid and live animal testing conducted in close consultation with KAOC staff and in compliance to the relevant guideline. 

Data from monitoring programs cannot be evaluated with confidence unless adequate quality assurance has been Incorporated Into the program designs. A good quality assurance program enables sources of error associated with each step of the monitoring efforts to be Identified and quantified. 

For example, if ever we want to understand whether global warming to a substantial degree is, or is not, caused by human activities, then we should first of all know and understand the performance of our models and the accuracy of data we put into these models. If ever we want to know whether all efforts to improve the quality of the sea for biota are effective, then we need to know the accuracy and uncertainty of all our data. If we do not want to take Quality Assurance into account, we will never be able to lay the solid scientific foundations for our research, political and legal actions etc. In other words we will remain only believers. 

If one wishes to predict the future of additive analysis in polymers, it is relevant to consider the prospects of further evolution of polymeric and additive materials the influence of legislation and environment instrumental developments and currently unsolved problems. It then becomes clear that additive analysis stands a fair chance remaining in use for some time, certainly in a strongly competitive environment, which will require improved product design specifications, quality assurance and research for new applications. As ideal production environments are rare, customer complaints will also require continuous attention. Government regulations are another reason for continuous analytical efforts. 

Independent quality assurance assessment of validation effort... 

Among them, standardization, testing, inspection and quality assurance activities have been developed to cover additional fields of products and services. At the same time great effort is being made worldwide to ensure a harmonised approach both in terminology and the context of various procedures. 

Clearly, the commercial or consultancy laboratory that tests sub-samples of a marketed product worth millions of pounds, or assesses the purity of pharmaceuticals, or analyses forensic samples, must have far higher levels of both accuracy and verifiability than student practical classes. There should, however, always be an effort to produce the most accurate and reliable results within the constraints of the laboratory facilities available, otherwise a lax attitude will produce work of doubtful interpretation that could mislead others, as well as giving little job satisfaction. Several books, which are more suited to the commercial sector, have been written on the quality of laboratory analysis, however some quality assurance practices could be beneficial in the smaller laboratory. A useful open-learning style book on basic concepts of quality in the analytical laboratory has been co-authored by staff at the Laboratory of the Government Chemist (Crosby et ai, 1995). 

Process owners must be capable to evaluate and interpret the effect of nonconformances and planned deviations on their systems. Process owners can evaluate the need and lead efforts for corrective or preventive action, ensuring adequate corrections and improvements are implemented. An effective QMS ensures deviations from approved processes are owned and adequately investigated by the process owner s and ultimately approved by their quality assurance counterpart. The knowledge of these events is the basis and foundation for the process owners to make a risk-based evaluation on whether or not process changes are required, documentation or training require modification, or continuous improvement efforts are warranted. 

The PQ is the phase in which either a technical system is tested over a long period of time (e.g., water system), or a complex technical system is tested overall (connected filling line). For many systems OQ is the last phase performed during qualification. If there are only a few performance tests needed, it might be more practical to include them during OQ or process validation. Combining OQ and PQ decreases the number of documents (less documentation work in the future) and cuts approval time and effort. Again, the procedure for PQ is the same as for IQ and OQ ([develop PQ protocols, approve PQ protocols (by the quality assurance, production, and technical departments), perform PQ, work out the PQ report, and approve the PQ report (by the quality assurance, production, and technical departments)]. The documentation and test description are identical to those in the OQ phase. 

Quality assurance in pharmaceutical companies embodies the effort to ensure that products have the strength, purity, safety, and efficacy represented in the company s new drug application (NDA). For new drug products, QA has also become the effort that is needed to satisfy the consumer or to achieve an established standard of excellence. The total effort requires that sound working relationships be developed among the QA, development, and production departments. Other groups such as engineering may be included in this effort. 

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