Quality assurance independence

The detection sensitivity of radiography is related among others to the properties and quality of industrial x-ray film systems. Changes of the products, variations due to different emulsions and combinations of products of different manufacturers can influence the decisive properties of film systems as classified in EN 584-1.To ensure the quality of industrial x-ray film systems a system for quality assurance open to all interested parties is proposed which is based on periodical round robin tests and quality controls of the manufacturer or an independent third party institution. 

You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

The organization chart shown in Figure 6.3-2 shows the Quality Assurance Manager high in the organization, to achieve independence of QA as required by 10CFR50 Appendix B. 

Each contract laboratory used in the QPMBS and the organization that coordinated the field phase already had in place a well-defined GLP-compliant quality assurance program. In addition to these existing quality assurance programs, an independent QA specialist was engaged to ensure compliance of all the aspects of the smdy with GLP requirements. 

Validation of extraction procedures is frequently lacking. A good assessment of quality assurance implies that the extraction recoveries are verified, e.g. by spiking of standard addition. A major drawback is that the spike is not always bound the same way as the compounds of interest. For the development of good extraction methods, materials with an incurred analyte (i.e. bound to the matrix in the same way as the unknown), which is preferably labelled (radioactive labelling would allow verification of the recovery), would be necessary. Such materials not being available, the extraction method used should be validated by other independent methods, e.g. by verification against known samples and by use of a recovery SPC chart. A mere comparison of extraction methods is no validation. 

Independent quality assurance assessment of validation effort... 

In analytical practice, they are best recognized by the determination of xtest as a function of the true value xtrue, and thus, by analysis of certified reference materials (CRMs). If such standards are not available the use of an independent analytical method or a balancing study may provide information on systematic errors (Doerffel et al. [1994] Kaiser [1971]). In simple cases, it may be possible, to estimate the parameters a, / , and y, in Eq. (4.5) by eliminating the unknown true value through appropriate variation of the weight of the test portions or standard additions to the test sample. But in the framework of quality assurance, the use of reference materials is indispensable for validation of analytical methods. 

The previous chapters of this book have discussed the many activities which laboratories undertake to help ensure the quality of the analytical results that are produced. There are many aspects of quality assurance and quality control that analysts carry out on a day-to-day basis to help them produce reliable results. Control charts are used to monitor method performance and identify when problems have arisen, and Certified Reference Materials are used to evaluate any bias in the results produced. These activities are sometimes referred to as internal quality control (IQC). In addition to all of these activities, it is extremely useful for laboratories to obtain an independent check of their performance and to be able to compare their performance with that of other laboratories carrying out similar types of analyses. This is achieved by taking part in interlaboratory studies. There are two main types of interlaboratory studies, namely proficiency testing (PT) schemes and collaborative studies (also known as collaborative trials). 

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. 

In the analysis of solid samples (e.g., LA-ICP-MS, SEM), synthetic standards cannot easily be prepared to the required concentrations, and accurate calibration of such techniques is often challenging. In some cases (e.g., SEM) pure element or single mineral standards are used, ideally with an appropriate standard for each element to be quantified. (It is possible in SEM, within limits, to use fewer standards than the number of elements to be determined, with the calibration for other elements being predicted from the response of the nearest element.) More often, however, multielement primary standards are used as the means of calibrating the instrument, e.g., for LA-ICP-MS of glasses, volcanics, and ceramics, two glass standards, NIST 610 and 612 (Pearce et al. 1996), are often used. It is always advisable to use more than one multielement standard in order to cover as wide a range of concentrations as possible, and to use at least one additional independent reference material as an unknown, for quality assurance purposes (see below). 

Sponsor companies use quality assurance units independent of the clinical research group to audit medical operations. Their role is to ensure that regulatory standards and company policies and procedures for clinical research are being followed in all countries where research is being conducted. 

Internal quality control is undertaken by the inclusion of particular reference materials, called control materials , into the analytical sequence and by duplicate analysis. The control materials should, wherever possible, be representative of the test materials under consideration in respect of matrix composition, the state of physical preparation and the concentration range of the analyte. As the control materials are treated in exactly the same way as the test materials, they are regarded as surrogates that can be used to characterise the performance of the analytical system, both at a specific time and over longer intervals. Internal quality control is a final check of the correct execution of all of the procedures (including calibration) that are prescribed in the analytical protocol and all of the other quality assurance measures that underlie good analytical practice. IQC is therefore necessarily retrospective. It is also required to be as far as possible independent of the analytical protocol, especially the calibration, that it is designed to test. 

The application of HPLC in routine environments, like pharmaceutical, food, or environmental analysis and particularly quality assurance, makes not only great demands on the robnstness of HPLC hardware, comprising pumps, column thermostats, and detection units, bnt in addition to the column reproducibility. Column reproducibility can be investigated at different levels of complexity Run-to-run reproducibility compares consecutive chromatographic runs, whereas long-term stability describes the column variance over several hundreds of injections. Column-to-column (batch-to-batch) reproducibility finally explores the match of independently fabricated chromatographic columns. Column characteristics that are routinely consulted for the determination of the robustness are retention, selectivity, column efficiency, and peak symmetry. 

The FDA retained the requirement for a quahty assurance unit, or function, to monitor studies for conformance to the regulations. It was emphasized that the function was administrative rather than scientific. The personnel responsible for quality assurance for a given study were required to be separate from, and independent of, the personnel responsible for the direction and conduct of that study. 

Similarly, ethos, the testimonial dependent upon the expertise and credibility of the witness, is critical. Evidence supplied by an impartial and credentialed observer may estabhsh comphance with control standard operating procedures (SOPs), accuracy of documentary evidence, and suitability of code design. Whereas the accuracy of logos transcends its interpretation, however, ethos proof must be evaluated on the basis of its source. Who said so , How does he or she know , and Why should he or she be trusted become the key questions. It is upon the importance of ethos that the important issues of independent, quality assurance (QA), and confirmatory investigation hes. Most ethos testimony takes the form of reports, observational records, and certifications. 

The design has been well proved in quality assurance and origin control of flavours and fragrances. A double-oven system is shown in the Fig. 17.3, with two independent temperature controls and two detectors (DM 1, DM 2). A live switching coupling piece is used to switch the effluent flow to either the first detector or the chiral column. With optimum pneumatic adjustment of the MDGC system, certain fractions are selectively transferred onto the chiral main column as they are eluted from the precolumn (heart-cutting technique) [15]. 

Other instruments for evaluation of electron beam process are real-time monitors. They provide a continuous display in real time of dose delivered to product, as well as the energy of the electron beam. Moreover, they can show the variations in dose across a wide web if multiple detectors are installed and provide alarm signals to warn the operator of high- and low-dose conditions, and record the performance of the processor for production control, quality assurance, and maintenance needs. The major advantage of these real-time instruments is that they monitor the current and beam energy independently. ... 

Where practical, the calibration standards used for production and quality assurance measurement equipment shall be traceable to the national standards of the National Bureau of Standards, Department of Commerce. If national standards are not practical for the parameter being measured, an independent reproducible standard shall be used. If no applicable standard exists, an in-house standard shall be developed and used. 

By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of... 

Quality assurance personnel must have the appropriate training, experience, familiarization with the manufacturing facility and products, enforced independence from the production chain of command, and the ability to review adherence to procedures, policies, and agreed-upon approaches to manufacturing quality pharmaceuticals. This helps to provide both an environment and a manufactured product that can withstand Food and Drug Administration (FDA) inspection and support a firm s reputation for quality products. 

URL http //www.os.dhhs.gov/ about/opdivs/hcfa.html Phone (410) 966-3000 200 Independence Avenue SW Washington, DC 20201 An agency within the Department of Health and Human Services that oversees Medicare, the federal portion of Medicaid, and quality assurance for federal health care programs. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

There is an appointed management representative quality assurance manager (ISO 9000 system coordinator), independent of other functions, with the necessary authority and responsibility to ensure that the requirements of the standard are implemented and maintained. 

Maintenance of an independent quality assurance unit within the laboratory to be responsible for a master schedule, sample receipt, and periodic inspections of the conduct and reporting of each laboratory study. 

Quality assurance—organizational independence, staff qualifications, self-inspection program, AQL, change control procedures, documentation and reports, complaint files, awareness of current regulations, statistical concept employed, batch record turnaround time, etc. 

The Quality Assurance and Laboratory Inspection Section at DCLS consists of a staff of five, and is responsible for a number of functions in addition to its QA function. Staff members inspect and certify independent and municipal laboratories in Virginia that conduct analyses covered by EPA s Safe Drinking Water Act. In addition, the section is responsible for administering the safety program for the laboratory. Another function of the section is to evaluate a number of products for compliance with bid specifications in support of procurement activities for the Division of Purchases and Supply. Because of these... 

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