980 resultados para QUALITY CONTROL OF MEDICINES


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The concept of the quality control circle (QCC) has worked well in Japanese industry in increasing efficiency, production, and profits. The author explores the QCC, its history and advantages, and tells how it could be adapted quite easily and effectively to the hospitality industry

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X-ray computed tomography (CT) imaging constitutes one of the most widely used diagnostic tools in radiology today with nearly 85 million CT examinations performed in the U.S in 2011. CT imparts a relatively high amount of radiation dose to the patient compared to other x-ray imaging modalities and as a result of this fact, coupled with its popularity, CT is currently the single largest source of medical radiation exposure to the U.S. population. For this reason, there is a critical need to optimize CT examinations such that the dose is minimized while the quality of the CT images is not degraded. This optimization can be difficult to achieve due to the relationship between dose and image quality. All things being held equal, reducing the dose degrades image quality and can impact the diagnostic value of the CT examination.

A recent push from the medical and scientific community towards using lower doses has spawned new dose reduction technologies such as automatic exposure control (i.e., tube current modulation) and iterative reconstruction algorithms. In theory, these technologies could allow for scanning at reduced doses while maintaining the image quality of the exam at an acceptable level. Therefore, there is a scientific need to establish the dose reduction potential of these new technologies in an objective and rigorous manner. Establishing these dose reduction potentials requires precise and clinically relevant metrics of CT image quality, as well as practical and efficient methodologies to measure such metrics on real CT systems. The currently established methodologies for assessing CT image quality are not appropriate to assess modern CT scanners that have implemented those aforementioned dose reduction technologies.

Thus the purpose of this doctoral project was to develop, assess, and implement new phantoms, image quality metrics, analysis techniques, and modeling tools that are appropriate for image quality assessment of modern clinical CT systems. The project developed image quality assessment methods in the context of three distinct paradigms, (a) uniform phantoms, (b) textured phantoms, and (c) clinical images.

The work in this dissertation used the “task-based” definition of image quality. That is, image quality was broadly defined as the effectiveness by which an image can be used for its intended task. Under this definition, any assessment of image quality requires three components: (1) A well defined imaging task (e.g., detection of subtle lesions), (2) an “observer” to perform the task (e.g., a radiologists or a detection algorithm), and (3) a way to measure the observer’s performance in completing the task at hand (e.g., detection sensitivity/specificity).

First, this task-based image quality paradigm was implemented using a novel multi-sized phantom platform (with uniform background) developed specifically to assess modern CT systems (Mercury Phantom, v3.0, Duke University). A comprehensive evaluation was performed on a state-of-the-art CT system (SOMATOM Definition Force, Siemens Healthcare) in terms of noise, resolution, and detectability as a function of patient size, dose, tube energy (i.e., kVp), automatic exposure control, and reconstruction algorithm (i.e., Filtered Back-Projection– FPB vs Advanced Modeled Iterative Reconstruction– ADMIRE). A mathematical observer model (i.e., computer detection algorithm) was implemented and used as the basis of image quality comparisons. It was found that image quality increased with increasing dose and decreasing phantom size. The CT system exhibited nonlinear noise and resolution properties, especially at very low-doses, large phantom sizes, and for low-contrast objects. Objective image quality metrics generally increased with increasing dose and ADMIRE strength, and with decreasing phantom size. The ADMIRE algorithm could offer comparable image quality at reduced doses or improved image quality at the same dose (increase in detectability index by up to 163% depending on iterative strength). The use of automatic exposure control resulted in more consistent image quality with changing phantom size.

Based on those results, the dose reduction potential of ADMIRE was further assessed specifically for the task of detecting small (<=6 mm) low-contrast (<=20 HU) lesions. A new low-contrast detectability phantom (with uniform background) was designed and fabricated using a multi-material 3D printer. The phantom was imaged at multiple dose levels and images were reconstructed with FBP and ADMIRE. Human perception experiments were performed to measure the detection accuracy from FBP and ADMIRE images. It was found that ADMIRE had equivalent performance to FBP at 56% less dose.

Using the same image data as the previous study, a number of different mathematical observer models were implemented to assess which models would result in image quality metrics that best correlated with human detection performance. The models included naïve simple metrics of image quality such as contrast-to-noise ratio (CNR) and more sophisticated observer models such as the non-prewhitening matched filter observer model family and the channelized Hotelling observer model family. It was found that non-prewhitening matched filter observers and the channelized Hotelling observers both correlated strongly with human performance. Conversely, CNR was found to not correlate strongly with human performance, especially when comparing different reconstruction algorithms.

The uniform background phantoms used in the previous studies provided a good first-order approximation of image quality. However, due to their simplicity and due to the complexity of iterative reconstruction algorithms, it is possible that such phantoms are not fully adequate to assess the clinical impact of iterative algorithms because patient images obviously do not have smooth uniform backgrounds. To test this hypothesis, two textured phantoms (classified as gross texture and fine texture) and a uniform phantom of similar size were built and imaged on a SOMATOM Flash scanner (Siemens Healthcare). Images were reconstructed using FBP and a Sinogram Affirmed Iterative Reconstruction (SAFIRE). Using an image subtraction technique, quantum noise was measured in all images of each phantom. It was found that in FBP, the noise was independent of the background (textured vs uniform). However, for SAFIRE, noise increased by up to 44% in the textured phantoms compared to the uniform phantom. As a result, the noise reduction from SAFIRE was found to be up to 66% in the uniform phantom but as low as 29% in the textured phantoms. Based on this result, it clear that further investigation was needed into to understand the impact that background texture has on image quality when iterative reconstruction algorithms are used.

To further investigate this phenomenon with more realistic textures, two anthropomorphic textured phantoms were designed to mimic lung vasculature and fatty soft tissue texture. The phantoms (along with a corresponding uniform phantom) were fabricated with a multi-material 3D printer and imaged on the SOMATOM Flash scanner. Scans were repeated a total of 50 times in order to get ensemble statistics of the noise. A novel method of estimating the noise power spectrum (NPS) from irregularly shaped ROIs was developed. It was found that SAFIRE images had highly locally non-stationary noise patterns with pixels near edges having higher noise than pixels in more uniform regions. Compared to FBP, SAFIRE images had 60% less noise on average in uniform regions for edge pixels, noise was between 20% higher and 40% lower. The noise texture (i.e., NPS) was also highly dependent on the background texture for SAFIRE. Therefore, it was concluded that quantum noise properties in the uniform phantoms are not representative of those in patients for iterative reconstruction algorithms and texture should be considered when assessing image quality of iterative algorithms.

The move beyond just assessing noise properties in textured phantoms towards assessing detectability, a series of new phantoms were designed specifically to measure low-contrast detectability in the presence of background texture. The textures used were optimized to match the texture in the liver regions actual patient CT images using a genetic algorithm. The so called “Clustured Lumpy Background” texture synthesis framework was used to generate the modeled texture. Three textured phantoms and a corresponding uniform phantom were fabricated with a multi-material 3D printer and imaged on the SOMATOM Flash scanner. Images were reconstructed with FBP and SAFIRE and analyzed using a multi-slice channelized Hotelling observer to measure detectability and the dose reduction potential of SAFIRE based on the uniform and textured phantoms. It was found that at the same dose, the improvement in detectability from SAFIRE (compared to FBP) was higher when measured in a uniform phantom compared to textured phantoms.

The final trajectory of this project aimed at developing methods to mathematically model lesions, as a means to help assess image quality directly from patient images. The mathematical modeling framework is first presented. The models describe a lesion’s morphology in terms of size, shape, contrast, and edge profile as an analytical equation. The models can be voxelized and inserted into patient images to create so-called “hybrid” images. These hybrid images can then be used to assess detectability or estimability with the advantage that the ground truth of the lesion morphology and location is known exactly. Based on this framework, a series of liver lesions, lung nodules, and kidney stones were modeled based on images of real lesions. The lesion models were virtually inserted into patient images to create a database of hybrid images to go along with the original database of real lesion images. ROI images from each database were assessed by radiologists in a blinded fashion to determine the realism of the hybrid images. It was found that the radiologists could not readily distinguish between real and virtual lesion images (area under the ROC curve was 0.55). This study provided evidence that the proposed mathematical lesion modeling framework could produce reasonably realistic lesion images.

Based on that result, two studies were conducted which demonstrated the utility of the lesion models. The first study used the modeling framework as a measurement tool to determine how dose and reconstruction algorithm affected the quantitative analysis of liver lesions, lung nodules, and renal stones in terms of their size, shape, attenuation, edge profile, and texture features. The same database of real lesion images used in the previous study was used for this study. That database contained images of the same patient at 2 dose levels (50% and 100%) along with 3 reconstruction algorithms from a GE 750HD CT system (GE Healthcare). The algorithms in question were FBP, Adaptive Statistical Iterative Reconstruction (ASiR), and Model-Based Iterative Reconstruction (MBIR). A total of 23 quantitative features were extracted from the lesions under each condition. It was found that both dose and reconstruction algorithm had a statistically significant effect on the feature measurements. In particular, radiation dose affected five, three, and four of the 23 features (related to lesion size, conspicuity, and pixel-value distribution) for liver lesions, lung nodules, and renal stones, respectively. MBIR significantly affected 9, 11, and 15 of the 23 features (including size, attenuation, and texture features) for liver lesions, lung nodules, and renal stones, respectively. Lesion texture was not significantly affected by radiation dose.

The second study demonstrating the utility of the lesion modeling framework focused on assessing detectability of very low-contrast liver lesions in abdominal imaging. Specifically, detectability was assessed as a function of dose and reconstruction algorithm. As part of a parallel clinical trial, images from 21 patients were collected at 6 dose levels per patient on a SOMATOM Flash scanner. Subtle liver lesion models (contrast = -15 HU) were inserted into the raw projection data from the patient scans. The projections were then reconstructed with FBP and SAFIRE (strength 5). Also, lesion-less images were reconstructed. Noise, contrast, CNR, and detectability index of an observer model (non-prewhitening matched filter) were assessed. It was found that SAFIRE reduced noise by 52%, reduced contrast by 12%, increased CNR by 87%. and increased detectability index by 65% compared to FBP. Further, a 2AFC human perception experiment was performed to assess the dose reduction potential of SAFIRE, which was found to be 22% compared to the standard of care dose.

In conclusion, this dissertation provides to the scientific community a series of new methodologies, phantoms, analysis techniques, and modeling tools that can be used to rigorously assess image quality from modern CT systems. Specifically, methods to properly evaluate iterative reconstruction have been developed and are expected to aid in the safe clinical implementation of dose reduction technologies.

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An array of Bio-Argo floats equipped with radiometric sensors has been recently deployed in various open ocean areas representative of the diversity of trophic and bio-optical conditions prevailing in the so-called Case 1 waters. Around solar noon and almost everyday, each float acquires 0-250 m vertical profiles of Photosynthetically Available Radiation and downward irradiance at three wavelengths (380, 412 and 490 nm). Up until now, more than 6500 profiles for each radiometric channel have been acquired. As these radiometric data are collected out of operator’s control and regardless of meteorological conditions, specific and automatic data processing protocols have to be developed. Here, we present a data quality-control procedure aimed at verifying profile shapes and providing near real-time data distribution. This procedure is specifically developed to: 1) identify main issues of measurements (i.e. dark signal, atmospheric clouds, spikes and wave-focusing occurrences); 2) validate the final data with a hierarchy of tests to ensure a scientific utilization. The procedure, adapted to each of the four radiometric channels, is designed to flag each profile in a way compliant with the data management procedure used by the Argo program. Main perturbations in the light field are identified by the new protocols with good performances over the whole dataset. This highlights its potential applicability at the global scale. Finally, the comparison with modeled surface irradiances allows assessing the accuracy of quality-controlled measured irradiance values and identifying any possible evolution over the float lifetime due to biofouling and instrumental drift.

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An array of Bio-Argo floats equipped with radiometric sensors has been recently deployed in various open ocean areas representative of the diversity of trophic and bio-optical conditions prevailing in the so-called Case 1 waters. Around solar noon and almost everyday, each float acquires 0-250 m vertical profiles of Photosynthetically Available Radiation and downward irradiance at three wavelengths (380, 412 and 490 nm). Up until now, more than 6500 profiles for each radiometric channel have been acquired. As these radiometric data are collected out of operator’s control and regardless of meteorological conditions, specific and automatic data processing protocols have to be developed. Here, we present a data quality-control procedure aimed at verifying profile shapes and providing near real-time data distribution. This procedure is specifically developed to: 1) identify main issues of measurements (i.e. dark signal, atmospheric clouds, spikes and wave-focusing occurrences); 2) validate the final data with a hierarchy of tests to ensure a scientific utilization. The procedure, adapted to each of the four radiometric channels, is designed to flag each profile in a way compliant with the data management procedure used by the Argo program. Main perturbations in the light field are identified by the new protocols with good performances over the whole dataset. This highlights its potential applicability at the global scale. Finally, the comparison with modeled surface irradiances allows assessing the accuracy of quality-controlled measured irradiance values and identifying any possible evolution over the float lifetime due to biofouling and instrumental drift.

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BACKGROUND: Although most gastrointestinal stromal tumours (GIST) carry oncogenic mutations in KIT exons 9, 11, 13 and 17, or in platelet-derived growth factor receptor alpha (PDGFRA) exons 12, 14 and 18, around 10% of GIST are free of these mutations. Genotyping and accurate detection of KIT/PDGFRA mutations in GIST are becoming increasingly useful for clinicians in the management of the disease. METHOD: To evaluate and improve laboratory practice in GIST mutation detection, we developed a mutational screening quality control program. Eleven laboratories were enrolled in this program and 50 DNA samples were analysed, each of them by four different laboratories, giving 200 mutational reports. RESULTS: In total, eight mutations were not detected by at least one laboratory. One false positive result was reported in one sample. Thus, the mean global rate of error with clinical implication based on 200 reports was 4.5%. Concerning specific polymorphisms detection, the rate varied from 0 to 100%, depending on the laboratory. The way mutations were reported was very heterogeneous, and some errors were detected. CONCLUSION: This study demonstrated that such a program was necessary for laboratories to improve the quality of the analysis, because an error rate of 4.5% may have clinical consequences for the patient.

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Microneedles (MNs) are emerging devices that can be used for the delivery of drugs at specific locations1. Their performance is primarily judged by different features and the penetration through tissue is one of the most important aspects to evaluate. For detailed studies of MN performance different kind of in-vitro, exvivo and in-vivo tests should be performed. The main limitation of some of these tests is that biological tissue is too heterogeneous, unstable and difficult to obtain. In addition the use of biological materials sometimes present legal issues. There are many studies dealing with artificial membranes for drug diffusion2, but studies of artificial membranes for Microneedle mechanical characterization are scarce3. In order to overcome these limitations we have developed tests using synthetic polymeric membranes instead of biological tissue. The selected artificial membrane is homogeneous, stable, and readily available. This material is mainly composed of a roughly equal blend of a hydrocarbon wax and a polyolefin and it is commercially available under the brand name Parafilm®. The insertion of different kind of MN arrays prepared from crosslinked polymers were performed using this membrane and correlated with the insertion of the MN arrays in ex-vivo neonatal porcine skin. The insertion depth of the MNs was evaluated using Optical coherence tomography (OCT). The implementation of MN transdermal patches in the market can be improved by make this product user-friendly and easy to use. Therefore, manual insertion is preferred to other kind of procedures. Consequently, the insertion studies were performed in neonatal porcine skin and the artificial membrane using a manual insertion force applied by human volunteers. The insertion studies using manual forces correlated very well with the same studies performed with a Texture Analyzer equipment. These synthetic membranes seem to mimic closely the mechanical properties of the skin for the insertion of MNs using different methods of insertion. In conclusion, this artificial membrane substrate offers a valid alternative to biological tissue for the testing of MN insertion and can be a good candidate for developing a reliable quality control MN insertion test.

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The construction industry requires quality control and regulation of its contingent,unpredictable environment. However, taking too much control from workers candisempower and demotivate. In the 1970s Deci and Ryan developed selfdeterminationtheory which states that in order to be intrinsically motivated, threecomponents are necessary - competence, autonomy and relatedness. This study aimsto examine the way in which the three ‘nutriments’ for intrinsic motivation may beundermined by heavy-handed quality control. A critical literature review analysesconstruction, psychological and management research regarding the control andmotivation of workers, using self-determination theory as a framework. Initialfindings show that quality management systems do not always work as designed.Workers perceive that unnecessary, wasteful and tedious counter checking of theirwork implies that they are not fully trusted by management to work without oversight.Control of workers and pressure for continual improvement may lead to resistanceand deception. Controlling mechanisms can break the link between performance andsatisfaction, reducing motivation and paradoxically reducing the likelihood of thequality they intend to promote. This study will lead to a greater understanding ofcontrol and motivation, facilitating further research into improvements in theapplication of quality control to maintain employee motivation.

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LOPES, Jose Soares Batista et al. Application of multivariable control using artificial neural networks in a debutanizer distillation column.In: INTERNATIONAL CONGRESS OF MECHANICAL ENGINEERING - COBEM, 19, 5-9 nov. 2007, Brasilia. Anais... Brasilia, 2007

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This study was conducted to assess the effect of air-dried Moringa stenopetala leaf (MSL) supplementation on carcass components and meat quality in Arsi-Bale goats. A total of 24 yearling goats with initial body weight of 13.6+/-0.25 kg were randomly divided into four treatments with six goats each. All goats received a basal diet of natural grass hay ad libitum and 340 g head^(−1) d^(−1) concentrate. The treatment diets contain a control diet without supplementation (T1) and diets supplemented with MSL at a rate of 120 g head^(−1) d^(−1) (T2), 170 g head^(−1) d^(−1) (T3) and 220 g head^(−1) d^(−1) (T4). The results indicated that the average slaughter weight of goats reared on T3 and T4 was 18.2 and 18.3 kg, respectively, being (P<0.05) higher than those of T1 (15.8 kg) and T2 (16.5 kg). Goats fed on T3 and T4 diets had higher (P<0.05) daily weight gain compared with those of T1 and T2. The hot carcass weight in goats reared on T3 and T4 diets was 6.40 and 7.30 kg, respectively, being (P<0.05) higher than those of T1 (4.81 kg) and T2 (5.06 kg). Goats reared on T4 had higher (P<0.05) dressing percentage than those reared in other treatment diets. The rib-eye area in goats reared on T2, T3 and T4 diets was higher (P<0.05) than those of T1. The protein content of the meat in goats reared on T3 and T4 was 24.0 and 26.4%, respectively being significantly higher than those of T1 (19.1%) and T2 (20.1%). In conclusion, the supplementation of MSL to natural grass hay improved the weight gain and carcass parts of Arsi-Bale goats indicating Moringa leaves as alternative protein supplements to poor quality forages.

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LOPES, Jose Soares Batista et al. Application of multivariable control using artificial neural networks in a debutanizer distillation column.In: INTERNATIONAL CONGRESS OF MECHANICAL ENGINEERING - COBEM, 19, 5-9 nov. 2007, Brasilia. Anais... Brasilia, 2007

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Compaction control using lightweight deflectometers (LWD) is currently being evaluated in several states and countries and fully implemented for pavement construction quality assurance (QA) by a few. Broader implementation has been hampered by the lack of a widely recognized standard for interpreting the load and deflection data obtained during construction QA testing. More specifically, reliable and practical procedures are required for relating these measurements to the fundamental material property—modulus—used in pavement design. This study presents a unique set of data and analyses for three different LWDs on a large-scale controlled-condition experiment. Three 4.5x4.5 m2 test pits were designed and constructed at target moisture and density conditions simulating acceptable and unacceptable construction quality. LWD testing was performed on the constructed layers along with static plate loading testing, conventional nuclear gauge moisture-density testing, and non-nuclear gravimetric and volumetric water content measurements. Additional material was collected for routine and exploratory tests in the laboratory. These included grain size distributions, soil classification, moisture-density relations, resilient modulus testing at optimum and field conditions, and an advanced experiment of LWD testing on top of the Proctor compaction mold. This unique large-scale controlled-condition experiment provides an excellent high quality resource of data that can be used by future researchers to find a rigorous, theoretically sound, and straightforward technique for standardizing LWD determination of modulus and construction QA for unbound pavement materials.

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Mammography equipment must be evaluated to ensure that images will be of acceptable diagnostic quality with lowest radiation dose. Quality Assurance (QA) aims to provide systematic and constant improvement through a feedback mechanism to address the technical, clinical and training aspects. Quality Control (QC), in relation to mammography equipment, comprises a series of tests to determine equipment performance characteristics. The introduction of digital technologies promoted changes in QC tests and protocols and there are some tests that are specific for each manufacturer. Within each country specifi c QC tests should be compliant with regulatory requirements and guidance. Ideally, one mammography practitioner should take overarching responsibility for QC within a service, with all practitioners having responsibility for actual QC testing. All QC results must be documented to facilitate troubleshooting, internal audit and external assessment. Generally speaking, the practitioner’s role includes performing, interpreting and recording the QC tests as well as reporting any out of action limits to their service lead. They must undertake additional continuous professional development to maintain their QC competencies. They are usually supported by technicians and medical physicists; in some countries the latter are mandatory. Technicians and/or medical physicists often perform many of the tests indicated within this chapter. It is important to recognise that this chapter is an attempt to encompass the main tests performed within European countries. Specific tests related to the service that you work within must be familiarised with and adhered too.

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With the construction of operational oceanography systems, the need for real-time has become more and more important. A lot of work had been done in the past, within National Data Centres (NODC) and International Oceanographic Data and Information Exchange (IODE) to standardise delayed mode quality control procedures. Concerning such quality control procedures applicable in real-time (within hours to a maximum of a week from acquisition), which means automatically, some recommendations were set up for physical parameters but mainly within projects without consolidation with other initiatives. During the past ten years the EuroGOOS community has been working on such procedures within international programs such as Argo, OceanSites or GOSUD, or within EC projects such as Mersea, MFSTEP, FerryBox, ECOOP, and MyOcean. In collaboration with the FP7 SeaDataNet project that is standardizing the delayed mode quality control procedures in NODCs, and MyOcean GMES FP7 project that is standardizing near real time quality control procedures for operational oceanography purposes, the DATA-MEQ working group decided to put together this document to summarize the recommendations for near real-time QC procedures that they judged mature enough to be advertised and recommended to EuroGOOS.

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Ten growth or wood-quality traits were assessed in three nearby Corymbia citriodora subsp. variegata (CCV) open-pollinated family-within-provenance trials (18 provenances represented by a total of 374 families) to provide information for the development of a breeding program targeting both pulp and solid-wood products. Growth traits (diameter at breast high over bark [DBH], height and conical volume) were assessed at 3 and 7 years of age. Wood-quality traits (density [DEN], Kraft pulp yield [KPY], modulus of elasticity [MoE] and microfibril angle [MfA]) were predicted using near-infrared spectroscopy on wood samples collected from these trials when aged between 10 and 12 years. The high average KPY, DEN and MoE, and low average MfA observed indicates CCV is very suitable for both pulp and timber products. All traits were under moderate to strong genetic control. In across- trials analyses, high (>0.4) heritability estimates were observed for height, DEN, MoE and MfA, while moderate heritability estimates (0.24 to 0.34) were observed for DBH, volume and KPY. Most traits showed very low levels of genotype × site interaction. Estimated age–age genetic correlations for growth traits were strong at both the family (0.97) and provenance (0.99) levels. Relationships among traits (additive genetic correlation estimates) were favourable, with strong and positive estimates between growth traits (0.84 to 0.98), moderate and positive values between growth and wood-quality traits (0.32 to 0.68), moderate and positive between KPY and MoE (0.64), and high and positive between DEN and MoE (0.82). However, negative (but favourable) correlations were detected between MfA and all other evaluated traits (−0.31 to −0.96). The genetic correlation between the same trait expressed on two different sites, at family level, ranged from 0.24 to 0.42 for growth traits, and from 0.29 to 0.53 for wood traits. Therefore simultaneous genetic improvement of growth and wood property traits in CCV for the target environment in south-east Queensland should be possible, given the moderate to high estimates of heritability and favourable correlations amongst all traits studied, unless genotype × site interactions are greater than was evident. © 2016 NISC (Pty) Ltd

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ISO 9000 is a family of international standards for quality management, applicable to all sizes of company, whether public or private.Management Systems ISO 9000 quality make up the human side, administrative and operating companies. By integrating these three aspects, the organization takes full advantage of all its resources, making results more efficiently, reducing administrative and operating expenses.With globalization and opening markets this has become a competitive advantage by providing further confidence and evidence to all customers, subcontractors, personnel and other stakeholders that the organization is committed to establishing, maintaining and improving levels acceptable quality products and services.Another advantage of quality systems is the clear definition of policies and functions, the staff is utilized according to their ability and focus on real customer needs.It should be mentioned that to achieve these benefits, it is necessary that management of the organization, is committed to the development of its quality system and to allocate financial and human resources to do so. These resources are minimal compared with the benefits you can achieve.