Quality assurance actions

Briefly, the quality management system is a combination of quality management, quality control and quality assurance. Quality assurance and quality control are components of the laboratory s quality management system. There is often confusion over the meaning of quality control and quality assurance and regrettably they are often used interchangeably. This is possibly because some quality control and quality assurance actions are interrelated. The definition of the terms can be found in the International Organization for Standardization (ISO) Standard, ISO 9000 2005 [2],... 

Even without certification or accreditation it is highly recommended to implement a number of quality assurance actions (they are mandatory for an accreditation) ... 

Quality control (QC) Those quality assurance actions that provide a means to control and measure the characteristics of measurement equipment and processes in order to meet established requirements. 

CFR 830.120 DOE Order 5700.6C (DOE 1991a), Quality Assurance actions which provide confidence that items and processes meet or exceed requirements and expectations. 

Quality assurance in any applied science and engineering project is an essential task. It is a disciplined approach in the provision of systems and components of nuclear power plants. The main objectives for the vessel are to ensure that eaeh part of the vessel manufacture is assembled, inspeeted, tested and operated strictly in accordance with the performanee requirements, reliability and safety codes and the designers intent. The quahty control is those quality assurance actions which provide a means to eontrol measure and monitor the characteristics of the vessel throughout its life. The quality assurance in practice embodies formal documentation and procedures ... 

The "feedback loop in the analytical approach is maintained by a quality assurance program (Figure 15.1), whose objective is to control systematic and random sources of error.The underlying assumption of a quality assurance program is that results obtained when an analytical system is in statistical control are free of bias and are characterized by well-defined confidence intervals. When used properly, a quality assurance program identifies the practices necessary to bring a system into statistical control, allows us to determine if the system remains in statistical control, and suggests a course of corrective action when the system has fallen out of statistical control. 

With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

The ISO definition states that quality assurance is all those planned and systematic actions necessary to provide adequate confidence that an entity will fulfill requirements for quality. Both customers and managers have a need for quality assurance as they are not in a position to oversee operations for themselves. They need to place trust in the producing operations, thus avoiding constant intervention. 

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. 

U.S. EPA has issued regulations and guidance primarily focusing on double liners and LCRSs.6 7 Several Federal Register notices and guidance documents have been published by U.S. EPA in this area.8-11 U.S. EPA also issued final regulations for double liners and for LDSs, including construction quality assurance (CQA) and response action plans.12-14... 

There must be systems in place to monitor the study while it is in progress and to check that all systems are working in accordance with GLP requirements, to record any problems identified and to ensure that remedial action is taken. The person responsible for these quality assurance procedures must be independent of the study being audited. In large organizations, there may be a separate Quality Assurance unit but this will not be practical in smaller organizations. 

Quality assurance is defined by Donaobedian as all actions taken to establish, protect, promote, and improve the quality of health care (Donobedian 2003). He describes quality of care as an attribute of a system (structure), a set of organized activities (process), and an outcome that results from both. The definitions are described in Table 3.1. It should be noted that the efficacy of a drug (the ability for improvement under the most favourable circumstances) is included in the structure and that the effectiveness of a dmg (real improvement in the care) is included in the process. 

The company has in place numerous checks and balances to prevent human error quality assurance (QA)-driven processes require validation (secondary checks/rechecks) of operator actions, sampling/analysis, etc. 

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. 

In a quality assurance programme, the control with a mean value of 10.5 mg and a standard deviation of 0.1 mg was analysed with a batch of test samples and gave a result of 10.0 mg. Which of the following actions should be taken ... 

Two important definitions are those of quality control and quality assurance. The former relates to operational techniques and activities, whereas the latter ensures that systematic actions are in place which enable confidence that the results meet the required level of quality, such as accuracy and precision. The concept of total quality control extends to areas such as management style and reduction of waste. 

Quality assurance unit records are exempt from routine FDA inspection and copying authority on the theory that such records are more likely to be complete and candid if they are exempt from review by the FDA. This exemption extends only to records of QA inspection and audit findings and records of corrective actions recommended and taken. All other QA records are subject to inspection and cop5dng by FDA. 

Summarize the quality data of batches delivered during the last 3 years and prepare trend analysis. Report deviations with regard to normal failure levels, out-of-specification situations, and corrective actions. The quality control and quality assurance managers shall review the trend. 

Alert levels. Every time an alert level is reached, the Manufacturing and Quality Assurance managers are notified. Verification of the satisfactory operation of all components of the environmental control system, including but not limited to HVAC systems, equipment operation procedures, and material handling procedures is performed. The results of the investigation and any actions taken are documented. 

Action levels. Every time the action level is reached, an investigation shall be initiated to determine the cause(s) for excursion. All the responses as defined under the alert level are executed. Segregation and quarantine of all exposed materials are performed until determination of the cause(s) for the excursion. Final decision is executed by the quality assurance management regarding product release for commercial distribution. Results of the investigation and any actions taken are documented. 

The actions taken in response to alert and action limits are defined in the environmental control program per manufacturing site SOP. Each time an action level is reached, an investigation is performed to determine the cause. If appropriate, product is segregated and quarantined until the cause of the failure has been determined and a decision is made by Quality Assurance regarding release. 

The PAT guidance facilitates introduction of new measurement and control tools in conjunction with well-established statistical methods such as design of experiments and statistical process control. It, therefore, can provide more effective means for product and process design and control, alternate efficient approaches for quality assurance, and a means for moving away from the corrective action to a continuous improvement paradigm. 

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