Product Variability Risks and Robust Design

1994 ◽  
Vol 208 (1) ◽  
pp. 9-19 ◽  
Author(s):  
K G Swift ◽  
A J Allen
Keyword(s):  
Quality Control ◽  
Robust Design ◽  
General Model ◽  
Best Practice ◽  
Quality Evaluation ◽  
Evaluation Methodology ◽  
Design For Manufacture ◽  
And Performance ◽  
Competitive Products

The design of a product largely predetermines its cost and quality, and there are therefore limits to the benefits that can be obtained by the application of best practice in manufacturing and quality control. The paper introduces a general model of design for quality and describes a systematic quality evaluation methodology to aid the development of quality competitive products. The application and performance of the methodology are described and its integration with techniques in design for manufacture and assembly is discussed.

scholarly journals A verified genomic reference sample for assessing performance of cancer panels detecting small variants of low allele frequency

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Wendell Jones ◽  
Binsheng Gong ◽  
Natalia Novoradovskaya ◽  
Dan Li ◽  
Rebecca Kusko ◽  
...  
Keyword(s):  
Quality Control ◽  
Allele Frequency ◽  
Liquid Biopsy ◽  
Limit Of Detection ◽  
Reference Sample ◽  
Digital Pcr ◽  
Detection Sensitivity ◽  
Analytical Accuracy ◽  
And Performance ◽  
Reference Samples

Abstract Background Oncopanel genomic testing, which identifies important somatic variants, is increasingly common in medical practice and especially in clinical trials. Currently, there is a paucity of reliable genomic reference samples having a suitably large number of pre-identified variants for properly assessing oncopanel assay analytical quality and performance. The FDA-led Sequencing and Quality Control Phase 2 (SEQC2) consortium analyze ten diverse cancer cell lines individually and their pool, termed Sample A, to develop a reference sample with suitably large numbers of coding positions with known (variant) positives and negatives for properly evaluating oncopanel analytical performance. Results In reference Sample A, we identify more than 40,000 variants down to 1% allele frequency with more than 25,000 variants having less than 20% allele frequency with 1653 variants in COSMIC-related genes. This is 5–100× more than existing commercially available samples. We also identify an unprecedented number of negative positions in coding regions, allowing statistical rigor in assessing limit-of-detection, sensitivity, and precision. Over 300 loci are randomly selected and independently verified via droplet digital PCR with 100% concordance. Agilent normal reference Sample B can be admixed with Sample A to create new samples with a similar number of known variants at much lower allele frequency than what exists in Sample A natively, including known variants having allele frequency of 0.02%, a range suitable for assessing liquid biopsy panels. Conclusion These new reference samples and their admixtures provide superior capability for performing oncopanel quality control, analytical accuracy, and validation for small to large oncopanels and liquid biopsy assays.

scholarly journals Characterizing the Effects of Explosive Ordnance Disposal Operations on the Human Body While Wearing Heavy Personal Protective Equipment

2021 ◽  
pp. 001872082199262
Author(s):  
Yi-Ning Wu ◽  
Adam Norton ◽  
Michael R. Zielinski ◽  
Pei-Chun Kao ◽  
Andrew Stanwicks ◽  
...  
Keyword(s):  
Human Body ◽  
Personal Protective Equipment ◽  
Evaluation Methodology ◽  
Protective Equipment ◽  
Physiological Measurement ◽  
Cognitive Stress ◽  
Explosive Ordnance Disposal ◽  
And Performance ◽  
Inspection Tasks ◽  
Muscle Activations

Objective To provide a comprehensive characterization of explosive ordnance disposal (EOD) personal protective equipment (PPE) by evaluating its effects on the human body, specifically the poses, tasks, and conditions under which EOD operations are performed. Background EOD PPE is designed to protect technicians from a blast. The required features of protection make EOD PPE heavy, bulky, poorly ventilated, and difficult to maneuver in. It is not clear how the EOD PPE wearer physiologically adapts to maintain physical and cognitive performance during EOD operations. Method Fourteen participants performed EOD operations including mobility and inspection tasks with and without EOD PPE. Physiological measurement and kinematic data recording were used to record human physiological responses and performance. Results All physiological measures were significantly higher during the mobility and the inspection tasks when EOD PPE was worn. Participants spent significantly more time to complete the mobility tasks, whereas mixed results were found in the inspection tasks. Higher back muscle activations were seen in participants who performed object manipulation while wearing EOD PPE. Conclusion EOD operations while wearing EOD PPE pose significant physical stress on the human body. The wearer’s mobility is impacted by EOD PPE, resulting in decreased speed and higher muscle activations. Application The testing and evaluation methodology in this study can be used to benchmark future EOD PPE designs. Identifying hazards posed by EOD PPE lays the groundwork for developing mitigation plans, such as exoskeletons, to reduce physical and cognitive stress caused by EOD PPE on the wearers without compromising their operational performance.

scholarly journals Commentary: Quality nutrition care is integral to the Oncology Care Model

2021 ◽  
Author(s):  
Mary Beth Arensberg ◽  
Beth Besecker ◽  
Laura Weldishofer ◽  
Susan Drawert
Keyword(s):  
Best Practice ◽  
Treatment Guidelines ◽  
Nutrition Therapy ◽  
Care Model ◽  
Nutrition Care ◽  
Ambulatory Oncology ◽  
Oncology Care ◽  
Improvement Programs ◽  
And Performance ◽  
Registered Dietitian Nutritionists

AbstractThe Oncology Care Model (OCM) is a US Centers for Medicare & Medicaid Services (CMS) specialty model implemented in 2016, to provide higher quality, more highly coordinated oncology care at the same or lower costs. Under the OCM, oncology clinics enter into payment arrangements that include financial and performance accountability for patients receiving chemotherapy treatment. In addition, OCM clinics commit to providing enhanced services to Medicare beneficiaries, including care coordination, navigation, and following national treatment guidelines. Nutrition is a component of best-practice cancer care, yet it may not be addressed by OCM providers even though up to 80% of patients with cancer develop malnutrition and poor nutrition has a profound impact on cancer treatment and survivorship. Only about half of US ambulatory oncology settings screen for malnutrition, registered dietitian nutritionists (RDNs) are not routinely employed by oncology clinics, and the medical nutrition therapy they provide is often not reimbursed. Thus, adequate nutrition care in US oncology clinics remains a gap area. Some oncology clinics are addressing this gap through implementation of nutrition-focused quality improvement programs (QIPs) but many are not. What is needed is a change of perspective. This paper outlines how and why quality nutrition care is integral to the OCM and can benefit patient health and provider outcomes.

Abstract 218: Expanding a Learning Collaborative Model in Chicago to Improve Door to Needle for Stroke Thrombolysis: Raising the Bar

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Shyam Prabhakaran ◽  
Renee M Sednew ◽  
Kathleen O’Neill
Keyword(s):  
Best Practices ◽  
Performance Improvement ◽  
Best Practice ◽  
Learning Collaborative ◽  
Collaborative Model ◽  
Stroke Registry ◽  
Chicago Area ◽  
Regional Collaboration ◽  
Content Expert ◽  
And Performance

Background: There remains significant opportunities to reduce door-to-needle (DTN) times for stroke despite regional and national efforts. In Chicago, Quality Enhancement for the Speedy Thrombolysis for Stroke (QUESTS) was a one year learning collaborative (LC) which aimed to reduce DTN times at 15 Chicago Primary Stroke Centers. Identification of barriers and sharing of best practices resulted in achieving DTN < 60 minutes within the first quarter of the 2013 initiative and has sustained progress to date. Aligned with Target: Stroke goals, QUESTS 2.0, funded for the 2016 calendar year, invited 9 additional metropolitan Chicago area hospitals to collaborate and further reduce DTN times to a goal < 45 minutes in 50% of eligible patients. Methods: All 24 hospitals participate in the Get With The Guidelines (GWTG) Stroke registry and benchmark group to track DTN performance improvement in 2016. Hospitals implement American Heart Association’s Target Stroke program and share best practices uniquely implemented at sites to reduce DTN times. The LC included a quality and performance improvement leader, a stroke content expert, site visits and quarterly meetings and learning sessions, and reporting of experiences and data. Results: In 2015, the year prior to QUESTS 2.0, the proportion of patients treated with tPA within 45 minutes of hospital arrival increased from 21.6% in Q1 to 31.4% in Q2. During the 2016 funded year, this proportion changed from 31.6% in Q1 to 48.3% in Q2. Conclusions: Using a learning collaborative model to implement strategies to reduce DTN times among 24 Chicago area hospitals continues to impact times. Regional collaboration, data sharing, and best practice sharing should be a model for rapid and sustainable system-wide quality improvement.

Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets

2021 ◽  
pp. 255-258
Author(s):  
Bhavana Habib ◽  
Jyoti Mittha
Keyword(s):  
Quality Control ◽  
Quality Evaluation ◽  
Indian Market ◽  
Disintegration Time ◽  
Innovator Product ◽  
Drug Content ◽  
Weight Variation ◽  
Generic Products

The aim of the present study was the evaluation and comparison between four different Metformin and Vildagliptin tablets which are commercially available in Indian market. These tablets were assessed for various pharmacopoeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (three generic and an innovator). These results show that the tested generic products were biopharmaceutically similar to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.

scholarly journals A Framework of Cloud Model Similarity-Based Quality Control Method in Data-Driven Production Process

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Sheng Hu ◽  
Shuanjun Song ◽  
Wenhui Liu
Keyword(s):  
Quality Control ◽  
Production Process ◽  
Control Method ◽  
Cloud Model ◽  
Data Driven ◽  
Monitoring Method ◽  
Control Approach ◽  
Acceptable Method ◽  
And Performance ◽  
Model Similarity

Considering the problem that the process quality state is difficult to analyze and monitor under manufacturing big data, this paper proposed a data cloud model similarity-based quality fluctuation monitoring method in data-driven production process. Firstly, the randomness of state fluctuation is characterized by entropy and hyperentropy features. Then, the cloud pool drive model between quality fluctuation monitoring parameters is built. On this basis, cloud model similarity degree from the perspective of maximum fluctuation border is defined and calculated to realize the process state analysis and monitoring. Finally, the experiment is conducted to verify the adaptability and performance of the cloud model similarity-based quality control approach, and the results indicate that the proposed approach is a feasible and acceptable method to solve the process fluctuation monitoring and quality stability analysis in the production process.

scholarly journals Exploring the Efficacy of Facebook Groups for Collective Occupant Learning About Using Their Homes

2017 ◽  
Vol 61 (7) ◽  
pp. 757-773 ◽  
Author(s):  
Magdalena Baborska-Narozny ◽  
Eve Stirling ◽  
Fionn Stevenson
Keyword(s):  
Urban Communities ◽  
Collective Efficacy ◽  
Best Practice ◽  
Evaluation Studies ◽  
Group Development ◽  
High Rate ◽  
Residential Developments ◽  
And Performance ◽  
Context Specific ◽  
Quality Learning

Using Facebook Groups to connect otherwise anonymous people that live in a single urban development is a relatively new phenomenon. Within residential developments, there are a number of common comfort, management, and performance issues experienced by many isolated inhabitants that are identified through building performance evaluation studies. Facebook is a ubiquitous social network tool and powerful communication platform, particularly popular among young adults. This article explores the use of closed Facebook Groups in relation to collective learning about home use in two residential communities in the United Kingdom. Data were collected through longitudinal digital and physical visits to case study residential developments and to the Facebook Group sites. Group development, dynamics, and the quality of knowledge sharing is evaluated. Findings are presented in relation to home use learning, as it proved to be a vital theme of each Group’s activity. We propose that weak-tie urban communities can develop collective efficacy through communicating on a Facebook Group that enables quality learning based on reciprocal sharing of experiences and knowledge by its members. This helps tackle comfort issues experienced, lower the cost of living, and share bespoke, context-specific home use best practice. Strong engagement and leadership of group administrators limited to early stages of the Groups’ formation followed by high rate of activity by the majority of members was key. There was a clear overlap observed between social media narrative and the physical experiences of daily life, which helps support residents. The analysis suggests the positive effect of the learning environment created bottom-up would not be easily transferable to professional applications.

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