Quality Assurance Requirements Research Articles

Aspects of dosimetry and clinical practice of skin brachytherapy: The American Brachytherapy Society working group report.

Nonmelanoma skin cancers (NMSCs) are the most common type of human malignancy. Although surgical techniques are the standard treatment, radiation therapy using photons, electrons, and brachytherapy (BT) (radionuclide-based and electronic) has been an important mode of treatment in specific clinical situations. The purpose of this work is to provide a clinical and dosimetric summary of the use of BT for the treatment of NMSC and to describe the different BT approaches used in treating cutaneous malignancies. A group of experts from the fields of radiation oncology, medical physics, and dermatology, who specialize in managing cutaneous malignancies reviewed the literature and compiled their clinical experience regarding the clinical and dosimetric aspects of skin BT. A dosimetric and clinical review of both high dose rate ((192)Ir) and electronic BT treatment including surface, interstitial, and custom mold applicators is given. Patient evaluation tools such as staging, imaging, and patient selection criteria are discussed. Guidelines for clinical and dosimetric planning, appropriate margin delineation, and applicator selection are suggested. Dose prescription and dose fractionation schedules, as well as prescription depth are discussed. Commissioning and quality assurance requirements are also outlined. Given the limited published data for skin BT, this article is a summary of the limited literature and best practices currently in use for the treatment of NMSC.

Determinants and barriers to lean implementation in food-processing SMEs – a multiple case analysis

This study explored contextual or determining factors and their impacts on lean manufacturing in small- and medium-sized enterprises (SMEs) operating in food-processing industries. In order to get an in-depth insight into the real situation at the work floor, this study adopted a multiple-case-study research approach. The inherent characteristics of food industries, such as mandatory quality assurance requirements, low shelf life of food products, and the extremely volatile demand and supply presented barriers to lean manufacturing adoption. In addition, the challenges of ‘change’ in an SME environment are distinct from those faced by large organizations. The small size of the plant, the traditional setup, and inflexible layout make it difficult to implement lean manufacturing in food-processing SMEs. The knowledge of contextual factors influencing lean manufacturing adoption in food processing SMEs will be a contribution to current knowledge. Many studies have explored lean constructs and tools, while far fewer have explored the crucial element of actually implementing these. The study will also help practitioners to anticipate potential obstacles and take proper measures to deal with them during lean implementation.

From supply chain to welding network: A framework of the prospects of networks in welding

Changes in the competitiveenvironment of global manufacturing markets mean that study of supply chainsand business networks has become an important aspect of efforts to enhanceefficiency in industrial manufacturing. The difference between a supply chain andnetwork approach is not unambiguous and the utility of such approaches inspecific manufacturing contexts is not always clear. This paper reviews networkingtheory as it pertains to industrial manufacturing and compares this theoreticalinformation with practices in welding manufacturing. The study analyzes weldingnetworks with the example of a three welding network structure with multiplelinkages. The analysis shows that the level of cooperation in welding manufacturingis insufficiently developed for optimal network prospects and that weldingnetworks have enormous potential to increase the profitability of productionthrough effective management of internal cooperation linkages and by focusingexternal cooperation on quality assurance and welding requirements. DOI: http://dx.doi.org/10.5755/j01.mech.21.2.8463

Impact of college-administered quality practice assessments: a longitudinal evaluation of repeat peer assessments of continuing competence in physiotherapists.

The College of Physiotherapists of Ontario (CPO) developed its peer practice assessment (PA) process under statutory requirements for quality assurance. Each year, a small percentage of physiotherapists, most selected at random, undergo PA. To shed light on continuing competence, we report outcomes from physiotherapists who have had two PAs. Records were extracted for physiotherapists with two unrelated PAs. Demographic features, peer assessors' scores, and consequent outcome decisions were examined. Outcomes were examined cross-sectionally (vs. other PAs in the same time period) and longitudinally (within cohort). Between 2004 and 2012, 117 Ontario physiotherapists underwent two unrelated PAs, typically 5-7 years apart. This cohort was representative of Ontario physiotherapists in terms of sex ratios, education, and years in practice. At the first PA (PA1), this cohort's outcomes were similar to those of other physiotherapists; at the second PA (PA2), they were better than others undergoing PA1 in the same period (p=0.02). The cohort's outcomes were better at PA2 than at PA1 (p<0.001). Physiotherapists are likely to meet professional standards in a repeat PA 5-7 years after an initial one. Additional research is required to identify risk factors for not meeting standards. The findings provide empirical evidence to guide ongoing development of the CPO's quality management program.

THE ROLE OF THE CONTINUOUS IMPROVEMENT TOOLS OF PROCESESS IN BUILDING RELATIONSHIPS IN SUPPLY CHAIN

Background: The aim of this paper is to determine the importan ce of the quality management and environmental management systems as well as operational improvement tools (such as TPS, Six Sigma, and Lean Management) in building partnerships in supply chai n. Methods: This paper contains the results of survey in compa nies operating in Poland and an analysis of the req uirements for suppliers in the implementation of the quality and environmental management systems elements as well as recommendation for them to implement process improvement tools (such as elements of the TPS, the conce pt of Lean Management and Six Sigma methodologies). Results: The results of the survey and the analysis of the examples show that companies that are buyers in the B2B market often define the very individualized to supp liers needs through detailed specifications definin g the requirements for quality assurance, performance increases, (for example, shortening implementation cycles), efficie ncy (cost reduction), safety, reducing the negative impact on the environment. Conclusions: The effectiveness of the action on improving the q uality of processes and products by building relationships with suppliers depends largely on the support provided to them. To achieve these objecti ves many companies introduce special development programs for suppliers.

Knowledge is Not a Product to be Bought or Sold: A South African Perspective

T can be little argument that knowledge is the wellspring of economic and social development. It is thus imperative for a country like South Africa that its higher education institutions become innovative, highquality powerhouses of knowledge production and dissemination. To succeed in this endeavor, the reform agenda has to take full cognizance of the need for efficiency, effectiveness, and responsiveness. However, it is possible and indeed necessary to do so without sacrificing social accountability and without subservience to the “market.” A tall order, some might say in light of increasing pressure to commercialize or commodify education. In a country like South Africa, and especially at this important point in its history, the transformation of higher education has to be seen in the context of the broader reconstruction and development of the country. In particular, it has to respond to the dual challenges of equity and development—that is, to overcome the fragmentation and inequality of the past and to meet current and future development challenges, especially in the context of an increasingly globalizing environment. An important element of our agenda in higher education is to focus on quality. Only through due attention to quality, including the building of inclusive institutional cultures, can there be meaningful access to higher education especially for those who were denied opportunities in the past. Only through combining access, quality, and success will the system be able to erode the domination of high-level occupations and knowledge production by privileged social groups. Quality improvement must, of course, include attention to the curriculum and to teaching and learning support. Clearly, no education system exists in isolation. However, an appropriate balance should be struck between global, local, or regional imperatives. In particular, the engagement of South Africa’s higher education system with the global order has to be guided by national objectives. To ignore this is to run the risk of further entrenching the unequal power relations between the developed and developing worlds. This can be illustrated by reference to the proliferation of foreign higher education institutions establishing operational bases in South Africa—either independently or in some cases in partnership with local public and private institutions. Prior to the promulgation of the 1997 Higher Education Act, there was a policy vacuum with respect to the regulation of private higher education, both local and foreign. This gap was exploited by overseas institutions, especially from countries threatened by declining student numbers and revenue, that set up shop in South Africa. Regrettably, many of these institutions appear to be driven by concerns largely unrelated to human resources development priorities or equity imperatives that are driving change in South Africa. Fortunately, through the implementation of our policy and legal frameworks, South Africa has been able to ensure the planned development of the private sector in ways that do not threaten the sustainability and integrity of the higher education system as a whole. This is not an attempt to exclude foreign institutions but rather to ensure that those who operate in South Africa do so with due regard to our policy goals and priorities and in ways that meet our national transformation agenda and quality assurance requirements. We have not allowed increased trade in education to undermine our national efforts to transform higher education and, in particular, to strengthen the public sector so that it can effectively participate in an increasingly globalizing environment. We cannot also countenance the excessive marketization and commodification of higher education, which among other factors can lead to the unfortunate homogenization of academic approaches and to the undermining of institutional cultures and academic values.

MOAtox: A comprehensive mode of action and acute aquatic toxicity database for predictive model development

The mode of toxic action (MOA) has been recognized as a key determinant of chemical toxicity and as an alternative to chemical class-based predictive toxicity modeling. However, the development of quantitative structure activity relationship (QSAR) and other models has been limited by the availability of comprehensive high quality MOA and toxicity databases. The current study developed a dataset of MOA assignments for 1213 chemicals that included a diversity of metals, pesticides, and other organic compounds that encompassed six broad and 31 specific MOAs. MOA assignments were made using a combination of high confidence approaches that included international consensus classifications, QSAR predictions, and weight of evidence professional judgment based on an assessment of structure and literature information. A toxicity database of 674 acute values linked to chemical MOA was developed for fish and invertebrates. Additionally, species-specific measured or high confidence estimated acute values were developed for the four aquatic species with the most reported toxicity values: rainbow trout (Oncorhynchus mykiss), fathead minnow (Pimephales promelas), bluegill (Lepomis macrochirus), and the cladoceran (Daphnia magna). Measured acute toxicity values met strict standardization and quality assurance requirements. Toxicity values for chemicals with missing species-specific data were estimated using established interspecies correlation models and procedures (Web-ICE; http://epa.gov/ceampubl/fchain/webice/), with the highest confidence values selected. The resulting dataset of MOA assignments and paired toxicity values are provided in spreadsheet format as a comprehensive standardized dataset available for predictive aquatic toxicology model development.

Comments: Innovation Follows Price

Editor's column Higher than normal oil prices during the past few years have led to a sharp rise in spending on upstream technology and innovation. The investment drivers are the need to extend the life of producing assets, improve operational efficiency, access new resources, and improve safety. Those are the results of a survey of 257 oil and gas executives and professionals who work for international and national oil companies, independents, and the service sector in Asia, Europe, and the United States. Conducted by Lloyd’s Register Energy and Longitude Research, the survey examined the rate of upstream innovation and which technologies were likely to become widely adopted in the near and medium term. Some of the participants in the study included Shell, Maersk Drilling, Woodside Energy, UK Onshore Operations Group, Enertech, GE Oil &amp; Gas, TouGas Oilfield Solutions, Horton Wison Deepwater, and the US National Energy Technology Laboratory. Among the findings are: 73% surveyed believe innovation in the upstream sector is increasing. 68% intend to increase R&amp;D budgets in the next 2 years. In the past 2 years, 46% of breakthroughs have been driven by international oil companies and 31% by pure exploration and production (E&amp;P) companies. Respondents expect an increasing role in technology spending by national oil companies (NOCs). Two-thirds of those polled expect NOCs to increase their spending on R&amp;D significantly. The technologies thought to be most valuable in the short term and likely to become mainstream by 2020 are automation, including remote and subsea operations; enhanced oil recovery advances; integrated real-time operating systems and related software advances; deposit-resistant materials and coatings; injection fluid and additive improvements; and improvements in inflow control devices and valves. High-impact technologies going mainstream in 2020 and shortly thereafter include high-pressure/high-temperature drilling, wellhead, and related technologies; multistage hydraulic fracturing; automated and wireless monitoring; digital wells, systems integration, and related technologies; remote sensing, radiofrequency identification, and related technologies; horizontal electrical submersible pumps; steam-assisted gravity drainage and other heavy-oil extraction techniques; composite risers and related technologies; and gellants and other fracking fluid ingredient improvements. The survey was conducted in April and May of this year, before the recent drop in oil prices, and respondents noted that high oil prices since the mid-2000s have led to hefty increases in R&amp;D and innovation spending. Although price seems to drive innovation spending, technology adoption is affected by industry culture. In the survey, only one quarter of respondents said their companies are “early adopters,” while 56% of respondents described themselves as “fast followers,” adopting technologies that have proved their worth. A major factor in slow adoption is the difficulty of testing technologies in appropriate, real-world conditions. More than one in five said this was the biggest problem ensuring quality-assurance requirements associated with deployment. JPT

Quality Management- The Key to Inherent Safety and Reliability of Prototype fast Breeder Reactor

The term “Quality management” has a specific meaning within many business sectors. Quality has metamorphosed from the synonyms of “Customer satisfaction” to “Customer delight”, thriving for excellence in every sphere of business with continuous improvements. In today’s business scenario, more often quality is perceived as “Fitness for purpose “focusing on the customer. But there is horizon beyond this as, “quality” is always intertwined with “safety and reliability” if the nature of the business is perilous. The prime focus for any nuclear industry is about the safety and reliability which can be accomplished only through the inherent quality. The quality embarks right from the construction phase of the nuclear power plant till the decommissioning and the four main components i.e. quality planning, quality control, quality assurance and quality improvement trek alongside. The high temperature low pressure system of fast breeder reactors using sodium as the coolant demands very high reliability and high degree of quality during each and every stage of construction of all the individual components for trouble free operation of the reactor for the committed years. The “Quality Assurance (QA)” plan of Prototype Fast Breeder Reactor is unique. The reactor being first of its kind in India, quality assurance starts right from the raw material procurement and extends through all the stages of plant till commissioning. The principal material of construction being stainless steel for the reactor components shall be handled with care following best engineering practices coupled with stringent QA requirements to avoid stress corrosion cracking in the highly brackish environment. Integranular stress corrosion cracking and hot cracking are additional factors to be addressed for the welding of stainless steel components. The low alloy ferritic steel like 9Cr-1Mo (mod) has been extensively deployed and the fabrication requires structured inspection, testing and QA plan. Corrosion protection and preservation during fabrication, erection and post erection is mandatory be it reinforcement bar or a reactor vessel.

The quality assurance of volumetric modulated arc therapy (VMAT) plans for early stage prostate cancer: a technical note.

As radiation therapy transitions from intensity modulated radiation therapy (IMRT) to volumetric modulated arc therapy (VMAT) it is important to consider the quality assurance (QA) of VMAT plans in light of what has previously been learned and developed in IMRT QA. This technical note assesses if IMRT based plan QA software, which has reduced the need in IMRT for phantom dose measurements on the linear accelerator, can be incorporated into VMAT QA processes. Twenty prostate cases were retrospectively planned using VMAT with one arc to deliver a prescription of 74 Gy in 37 fractions. A plan QA was performed using both IMSure (version 3.3), a software‐based IMRT QA program, and ArcCHECK (version 6.2.3.5713), a phantom‐based VMAT QA tool. Outcomes assessed included the time needed to perform the QA of both the IMSure and ArcCHECK QA methods, and agreement between planned dose and QA measured dose. On average per case, the ArcCHECK technique needed 31.5 min to perform the VMAT plan QA, while IMSure required 3.5 min to perform the same QA. All 20 cases passed dosimetric QA using ArcCHECK. However, using IMSure, three cases failed dosimetric QA using the departments existing IMRT QA criteria. This research has demonstrated that the IMRT QA software IMSure may be incorporated into the QA of VMAT plans, however the criteria to assess the dosimetry of the VMAT plans may need to be different to that for IMRT cases. The implication of this research for radiation therapists is to be critically aware of the differences between the plan QA requirements and methods for IMRT and those required for VMAT.

Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe

Pharmaceutical preparations are medicines that the pharmacist makes for the special needs of the patients that the pharmaceutical industry cannot comply for economic and logistic reasons. Pharmacy compounding is still an important component of pharmacy practice and a valuable therapeutical service that is an integrant part of the modern health care system, but its legislation is not harmonized among European and US countries.In 2011 the Committee of Ministers of the Council of Europe has adopted a Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. Aim of this resolution is to harmonize quality assurance and standards for pharmacy-made medicinal products among European countries and to pass the gap in quality assurance and standards between preparation in pharmacies and medicines prepared by the pharmaceutical industry. This article will analyze the actual rules and technical norms that regulate compounding activity and the expectations resultants from the new European and US laws.

Regulatory Requirements for PET Drug Production.

The Food and Drug Administration (FDA) issued the final rule for title 21 of Code of Federal Regulations part 212 regarding the regulations on current good manufacturing practice for PET drugs. The regulations are intended to ensure that PET drugs meet the safety and quality assurance requirements of the Federal Food, Drug, and Cosmetic Act. The new regulation became effective December 12, 2011, but the FDA used regulatory discretion to allow new drug applications and abbreviated new drug applications to be filed until June 12, 2012, without interruption of the existing PET drug production for human use. The production of PET drugs for both clinical use and clinical research use are outlined in this continuing education module, including an overview of specific requirements for compliance. Additionally, FDA preapproval inspections and postapproval reporting requirements are reviewed.

The cumulative risk of false-positive screening results across screening centres in the Norwegian Breast Cancer Screening Program

BackgroundRecall for assessment in mammographic screening entails an inevitable number of false-positive screening results. This study aimed to investigate the variation in the cumulative risk of a false positive screening result and the positive predictive value across the screening centres in the Norwegian Breast Cancer Screening Program. MethodsWe studied 618,636 women aged 50–69 years who underwent 2,090,575 screening exams (1996–2010. Recall rate, positive predictive value, rate of screen-detected cancer, and the cumulative risk of a false positive screening result, without and with invasive procedures across the screening centres were calculated. Generalized linear models were used to estimate the probability of a false positive screening result and to compute the cumulative false-positive risk for up to ten biennial screening examinations. ResultsThe cumulative risk of a false-positive screening exam varied from 10.7% (95% CI: 9.4–12.0%) to 41.5% (95% CI: 34.1–48.9%) across screening centres, with a highest to lowest ratio of 3.9 (95% CI: 3.7–4.0). The highest to lowest ratio for the cumulative risk of undergoing an invasive procedure with a benign outcome was 4.3 (95% CI: 4.0–4.6). The positive predictive value of recall varied between 12.0% (95% CI: 11.0–12.9%) and 19.9% (95% CI: 18.3–21.5%), with a highest to lowest ratio of 1.7 (95% CI: 1.5–1.9). ConclusionsA substantial variation in the performance measures across the screening centres in the Norwegian Breast Cancer Screening Program was identified, despite of similar administration, procedures, and quality assurance requirements. Differences in the readers’ performance is probably of influence for the variability. This results underscore the importance of continuous surveillance of the screening centres and the radiologists in order to sustain and improve the performance and effectiveness of screening programs.

Progress on TF and PF Conductor for ITER in China

China International Nuclear Fusion Energy Program Execution Center (ITER China), the China Domestic Agency for ITER, is in charge of about 7.51% of the Toroidal Field (TF) conductors, 65.15% of the Poloidal Field (PF) conductors, namely 11 TF conductors and 60 PF conductors. All those conductors are supplied in-kind by ITER China. Following success in qualification test on full-scale short conductor samples, ITER China is stepping into the series production of the TF and PF super conductors. Several tons of Nb3Sn and NbTi strands were manufactured, tested, and delivered from strands supplier to assembling supplier under the supervision of the ITER China and all the conductor manufacture processes complied with ITER quality assurance requirements. This article reports the progress on TF and PF conductor of ITER China up to December 2012.

Production management and quality assurance for the fabrication of the In-Vessel Components of the stellarator Wendelstein 7-X

The In-Vessel Components (IVC) of the stellarator Wendelstein 7-X consist of the divertor components and the first wall (FW) with their internal water cooling supply and a set of diagnostics. Due to the significant amount of different components, including many variants, a tool called Production Managing System (PMS) has been developed to organize the fabrication and the associated quality assurance. The PMS works by building a database containing the basic parts and assembly data, manufacturing and quality control plans, and available machine capacity. The creation of this database is based mainly on the parts lists, the manufacturing drawings, and details of the working flow organization. As a consequence of the learning process and technical adjustments during the design and manufacturing phase, the database needed to be permanently updated. Therefore an interface tool to optimize the data preparation has been developed. PMS has been demonstrated to be an efficient tool to support the IVC production activities providing reliable planning estimates, easily adaptable to problems encountered during the fabrication and provided a basis for the integration of quality assurance requirements.

Hand Calculations for Transport of Radioactive Aerosols through Sampling Systems

Workplace air monitoring programs for sampling radioactive aerosols in nuclear facilities sometimes must rely on sampling systems to move the air to a sample filter in a safe and convenient location. These systems may consist of probes, straight tubing, bends, contractions and other components. Evaluation of these systems for potential loss of radioactive aerosols is important because significant losses can occur. However, it can be very difficult to find fully described equations to model a system manually for a single particle size and even more difficult to evaluate total system efficiency for a polydispersed particle distribution. Some software methods are available, but they may not be directly applicable to the components being evaluated and they may not be completely documented or validated per current software quality assurance requirements. This paper offers a method to model radioactive aerosol transport in sampling systems that is transparent and easily updated with the most applicable models. Calculations are shown with the R Programming Language, but the method is adaptable to other scripting languages. The method has the advantage of transparency and easy verifiability. This paper shows how a set of equations from published aerosol science models may be applied to aspiration and transport efficiency of aerosols in common air sampling system components. An example application using R calculation scripts is demonstrated. The R scripts are provided as electronic attachments.

Obtaining and maintaining ABET accreditation

Accreditation is an important method for higher education institutions to meet accountability and quality assurance requirements. In this article, we share our experience of obtaining and maintaini...

Long term performance of metal seals for transport and storage casks

AbstractDual purpose casks for the transportation and storage of spent nuclear fuel and other radioactive materials require very high leak tightness of lid closure systems under accident conditions as well as in the long term to prevent activity release. For that purpose metal seals of specific types with an inner helical spring and outer metal liners are widely used and have shown their excellent performance if certain quality assurance requirements for fabrication and assembling are satisfied. Well defined surface roughness, clean and dry inert conditions are therefore essential. No seal failure in a loaded cask happened under these conditions until today. Nevertheless, the considered and licensed operation period is limited and all safety assessments have been performed and approved for this period of time which is 40 years in Germany so far. However, in the meantime longer storage periods might be necessary for the future and therefore additional material data will be required. BAM is involved in the ...

Education for sustainable development and quality assurance in universities in China and the Nordic countries: a comparative study

The global goal for education for sustainable development (ESD) is to integrate it at all levels of education. For ensuring it the change has to be put in practice, by transforming universities. The Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) strive to be among the regions that lead the way in enhancing ESD, and want to increase cooperation with China. It is therefore interesting to compare the region with China. We compared ESD and quality assurance between these areas at both policy and implementation levels. The former was based on literature, and the latter was studied with specific surveys in academia in both regions; in two provinces in China and in the Nordic countries. We investigated the possibilities to improve ESD in these regions by benefiting from quality assurance requirements. We found that both regions enhance ESD. The rather similar quality assurance requirements do not include ESD. In China, the respondents viewed quality assurance as sustainable development.

Performance of Contracting Agencies by Adopting Checklists in Quality Assessment

In order to improve quality in construction industry it is important to understand the factors affecting the quality and analyze these factors in terms of its effects. Better management would result in increased efficiency with reduced quality failures while saving tremendous amount of money. Better management is dependent on the different agencies involved in a project and their attitude towards quality improvement, measurement and efforts taken to achieve quality. The purpose of this paper is to provide information regarding assessment of contractor's performance, from the point of view of achieving quality on site. Checklist fulfills the criteria for quality assurance requirements of construction activities. The checklists are provided as part of the evaluation process for the quality assurance plan.