Part Of Quality Control Procedures Research Articles

Quality Control and Management in Manufacturing Industries: A Critical Analysis

A crucial component of India's manufacturing industry is quality control and management. Manufacturers work hard to make sure their products satisfy customers' expectations and adhere to legal regulations. During the production process, items are monitored and examined as part of quality control procedures to find and fix any flaws or deviations from required specifications. This covers the utilization of instruments such as statistical process control, inspection, and testing.Implementing quality management requires setting up procedures and systems to guarantee consistent quality at all manufacturing phases, from raw materials to completed goods.In order to remove errors and optimize operations, it also includes ongoing improvement initiatives like lean manufacturing and Six Sigma.Effective quality control and management procedures result in higher-quality products, higher customer satisfaction, lower costs, and greater competitiveness on the international market. As they work to develop high-quality goods that satisfy the various needs of domestic and international clients, Indian manufacturers place a strong priority on quality control and management. Sample of 185 respondents involved in quality control and management were surveyed to analyze different Quality Control and Management in manufacturing industries where respondents choose “Yes” or “No” for all the questions. It is found that Systematic evaluation and monitoring to meet regulatory standards and consumer expectations and Quality Control and Management in manufacturing industries help with fault detection and correction, decrease variability, and enhance overall product quality.

Abstract P5-01-02: Glandular dose in contrast-enhanced dual-energy mammography

Abstract INTRODUCTION Estimation of the Average Glandular Dose (AGD) absorbed by the breast during x-ray based examination is an established part of quality control procedures for breast imaging, both for standard mammography and new techniques as digital breast tomosynthesis (DBT) and contrast enhanced digital mammography (CEDM). It is however fundamental that every optimization program obtains an adequate imaging quality. In our study we evaluated the AGD absorbed by the breast, during CEDM examinations, performed with Dual Energy (DE) technique in our Department. MATERIALS AND METHODS We retrospectively evaluated 37 DE mammograms; we reported and analyzed AGD, Entrance Skin Exposure (ESE), anode/filter combinations, breast thickness, kV (kilovolt), mAs (milliAmpere per second), and compression in daN (decaNewton) values, for each mammography view obtained on high and low energy. In 10 Patients, it was possible to compare DE with a recent standard mammography performed on the same mammography unit. RESULTS AGD values for the entire DE study, in craniocaudal and mediolateral oblique views, resulted between 4.23 mGy and 13.44 mGy; based on the breast thickness (27-79 mm) and on the anod/filter combination. We found out a significantly lower AGD for small breast thicknesses and Mo/Rh and Mo/Cu combination compared to Rh/Rh and Rh/Cu. In the whole study evaluation, the AGD percentage report due to low and high energy acquisitions resulted between 76.8% and 81.6%, and between 18.4% and 23.2%, respectively. For the 10 Patients in which was possible a direct comparison with the data obtained with recent standard mammography, resulted a ratio between DE AGD and standard mammography AGD variable from 1.43 to 2.48 (mean value: 2.0), again with lower AGD values obtained with Mo/Rh - Mo/Cu combination and for small breast thicknesses. AGD ratio between low energy and standard mammography acquisition resulted between 1.23 and 3.31. DISCUSSION CEDM is proving to have all the potential to get a definite role in diagnosis and breast tumor staging, providing a direct correlation between morphologic and functional imaging. In our study we assessed the dosimetry to determine if an additional x-ray exposure will be a limit to DE use and, if that is the case, in which measure. Data in the literature on DE dosimetry are still spare and extremely heterogenous. In any case, the increase of delivered dose could be justifiable when compared to the great benefits given by this technique in breast cancer early diagnosis and staging, especially in dense breast tissue, in the follow-up of Patients with breast cancer history and in case of MRI incompatibility. Furthermore, when compared to MRI, CEDM is an easy-access, low-cost, fast and well accepted exam by the patient. CONCLUSIONS Although the risk of induced carcinogenesis associated with x-ray breast modalities is small, dosimetric aspects should be considered both for the risk evaluation and for optimization of acquisition systems; with the advance of the technologies we will be able to have a dose reduction by maintaining high quality standards. Results obtained from this preliminary study needs to be extended by a larger case study to get a complete evaluation and comprehension of the phenomenon. Citation Format: Cossu E, Castellani F, Fiaschetti V, Mariateresa M, Tiziana R, Angelo T. Glandular dose in contrast-enhanced dual-energy mammography [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-01-02.

Recombinant mutagenic 3ABC protein and monoclonal antibody for quality-control testing in foot-and-mouth disease vaccines

To achieve the goal of performing quality control on vaccines for foot-and-mouth disease several steps were performed in this study. First, the gene that encodes the 3ABC region of the A24 Cruzeiro strain (which is used in vaccine production) was amplified. Second, to improve protein stability, the 3ABC protein was mutated at the 3Cpro catalytic site and cloned the amplification products in the pET-SUMO expression vector. In the third step, the resulting recombinant protein was tested, which the polyclonal antibody recognized, with the semi-purified viral 3ABC protein using an immunoassay test. Fourth, the muted recombinant protein was used to produce a monoclonal antibody. Of the 217 clones obtained, two of them that were particularly stable (mAb2D3 and mAb3D12) were selected to work with. One showed better results, as characterized by immunoassay (ELISA), Western blotting, spot synthesis, and sequencing methodologies; it also showed high reactivity against the 3ABC protein. This kind of monoclonal antibodies, which was considered as immunochemical inputs, have been used in industrial processes as part of quality-control procedures, to evaluate the elimination of the 3ABC protein so as to ensure regulatory approval of the vaccine. They have also been used in immunological tests to distinguish infected from vaccinated animals.

Education of Phlebotomy Teams Improves Blood Volume in Blood Culture Bottles

The volume of blood sampled for blood culture determines its sensitivity. We measured low mean blood volumes in submitted aerobic (8.38 ± 3.88 ml) and anaerobic (7.16 ± 3.83 ml) blood culture bottles. Educational seminars were held for phlebotomy teams, and renewed measurements thereafter revealed significantly higher blood volumes in submitted aerobic (9.77 ± 4.42 ml) and anaerobic (8.30 ± 3.64 ml) bottles. Education of phlebotomy teams improves the blood volume in blood culture bottles and should be part of quality control procedures.

An alternative method for noise analysis using pixel variance as part of quality control procedures on digital mammography systems

According to the European Guidelines for quality assured breast cancer screening and diagnosis, noise analysis is one of the measurements that needs to be performed as part of quality control procedures on digital mammography systems. However, the method recommended in the European Guidelines does not discriminate sufficiently between systems with and without additional noise besides quantum noise. This paper attempts to give an alternative and relatively simple method for noise analysis which can divide noise into electronic noise, structured noise and quantum noise. Quantum noise needs to be the dominant noise source in clinical images for optimal performance of a digital mammography system, and therefore the amount of electronic and structured noise should be minimal. For several digital mammography systems, the noise was separated into components based on the measured pixel value, standard deviation (SD) of the image and the detector entrance dose. The results showed that differences between systems exist. Our findings confirm that the proposed method is able to discriminate systems based on their noise performance and is able to detect possible quality problems. Therefore, we suggest to replace the current method for noise analysis as described in the European Guidelines by the alternative method described in this paper.

Reliability of Urinary Albumin, Total Protein, and Creatinine Assays after Prolonged Storage

This study investigated the effect of long-term storage at -70 degrees C on urinary albumin, protein, and creatinine measurements in the Family Investigation of Nephropathy and Diabetes, a multicenter study designed to identify genes for diabetic nephropathy. Spot urine samples were collected at eight centers and shipped overnight on ice packs to a central laboratory. Samples were aliquotted and frozen at -70 degrees C for a median of 8 d before initial assay. As part of quality control procedures to determine interassay variability, 351 replicate samples were retrieved from storage at -70 degrees C after a median storage time between original and quality control analyses of 126 d (range 28 to 869 d). Freezer time was characterized as the difference in days between the initial assay and quality control assay. Percentage difference [(quality control - original/original) x 100%] between samples was regressed on storage time and adjusted for original value, age, race, gender, hypertension, and diabetes. After adjustment, freezer time per 30 d was associated with small decreases in percentage difference of urinary albumin (0.25%, P = 0.02), total protein (0.23%, P = 0.02), and albumin-to-creatinine ratio (0.34%, P = 0.001). Urinary creatinine levels were not affected by freezer time (P = 0.25). Measurements of urinary albumin, total protein, and albumin-to-creatinine ratio are minimally affected by storage at -70 degrees C for approximately 2.5 yr. Prolonged storage results in small decreases of urinary albumin and protein that do not substantially affect phenotype classification of overt renal disease.

Porcine cytomegalovirus in pigs being bred for xenograft organs: progress towards control.

In human medicine, human cytomegalovirus (HCMV) is readily transmitted by organ transplant causing end-organ disease and triggering graft rejection in recipients. Because of a chronic shortage of human organs, pigs transgenic for human complement control proteins are being considered as potential donors. Such xenotransplantation raises concerns about the potential zoonotic transmission of viruses including porcine cytomegalovirus (PCMV), an endemic infection of pigs. Similar to HCMV and PCMV transmission is thought to occur in utero and perinatally. We used quantitative polymerase chain reaction to examine the prevalence, organ distribution and viral load of PCMV in human decay accelerating factor (CD55) transgenic pigs. In animals reared under conventional farm conditions, virus was identified in a wide range of organs including potential xenografts (liver, kidney and heart). The spleen was PCMV DNA positive in all infected pigs. Examination of foetal spleens failed to identify evidence of transplacental infection and prospective monitoring of two litters showed that infection occurred in the postnatal period. This transmission was prevented by hysterotomy derivation and barrier rearing. Our findings demonstrate that PCMV could be eradicated from pig herds being bred for xenotransplantation and argue that the spleen from donor animals should be examined as part of quality control procedures if clinical trials proceed.

Use of similarity measures for quality control of benthic diatom samples

A method for evaluating the similarity of replicate benthic diatom samples based on the Bray–Curtis similarity measure is described. This technique may be useful as part of quality control procedures where objective performance measures are required. Levels of similarity >60% typically indicate good agreement between the primary analyst and auditor. However, an evaluation of 57 comparisons indicated that achievable levels of similarity were dependent upon the species diversity of the sample, with samples with high species diversity typically having lower levels of similarity than samples with low species diversity. Whilst a threshold value of 60% is adequate for most samples, a stiffer threshold of 70% should be applied to samples with very low levels of diversity.

Dermal route in systemic exposure.

To evaluate risk from dermal exposure, the amount of material on the skin must first be measured. The potential for dermal uptake must then be assessed for the potential health effects from systemic exposure. No standard methods exist for studying these processes, and published data are not comparable because of the different techniques used. Future validated methodology should provide a sound scientific basis for risk assessment. Methods for measuring skin and surface contamination will require development of reference contaminated surfaces and skin as part of quality control procedures. Biological monitoring is a valuable tool in the assessment of dermal absorption, in contributing to the validation of in vitro techniques, and in risk assessment and management. It will be necessary to conduct detailed investigations to support risk assessment for dermal exposure. Ultimately, predictive models will be established for exposure and for dermal absorption to support a generic approach and allow risk assessment strategies appropriate to actual workplace situations.

The Incidence of Cervical and Vaginal Dysplasia After Exposure to DES-Reply

In Reply.— Dr Richart asserts that advances in our knowledge about the morphological appearances of HPV could have led to bias in the National Collaborative Diethylstilbestrol Adenosis Project study, in which tissue slides have been analyzed since 1976. 1 Although some bias is possible, we believe it to be minimal since the slides disclosing dysplasia were reviewed by all pathologists and cytologists, and many slides were rereviewed periodically over a period of years as part of quality-control procedures. A major problem facing all pathologists and cytologists today is in fact the diagnostic criteria distinguishing HPV lesions from dysplasia and carcinoma in situ (collectively, Richart's CIN). Do lesions exhibiting both koilocytosis and marked nuclear atypia represent one disease state or both simultaneously? We have demonstrated that such lesions may have HPV demonstrable by immunoperoxidase stains while also demonstrating aneuploidy by microspectrophotometric analysis of Feulgen-stained slides. 2 We believe that many lesions