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ROW regulatory guidance
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
Manufacture of an SBP should be based on a comprehensively designed production process, taking all relevant guidelines into account. The manufacturer must demonstrate the consistency and robustness of the manufacturing process by implementing good manufacturing practices, modern quality control, and assurance procedures, in-process controls, and process validation. The manufacturing process should meet the same standards as required by the NRA for originator products. It should be optimized to minimize differences between the SBP and RBP in order to (1) maximize the reduction in clinical testing requirements for the SBP based upon the clinical history of the RBP and (2) minimize any predictable impact on the clinical safety and efficacy of the product. Some differences between the SBP and RBP are expected and may be acceptable, provided that appropriate justification of the lack of impact on clinical performance can be given.
A Process-Driven Socio- Technical Approach to Engineering High- Performance Organisations
Published in Peter Vink, Advances in Social and Organizational Factors, 2012
Heston and Phifer (2009) ascribe the following organisational benefits to MBPI: Improving consistency and repeatability: consistency and repeatability assist with minimising process variation, a major source of product defects. It also allows project staff to move into and out of projects more easily by having clearly defined roles and responsibilities.Improving communication: achieved through the adoption of a common vocabulary with clearly prescribed meanings that allows project staff, clients and business partners to communicate with less ambiguity.Enabling more improvement: process improvement programs create an environment which is conducive to further improvement. Beyond consistency and repeatability comes the ability to measure and record process performance. This performance data can then be used to plan further improvements and to benchmark against best practice.Providing motivation: objective targets, for example being assessed at a certain level of maturity, become a visible motivator for project staff to maintain their efforts to improve process performance.
Control Charts
Published in Lawrence S. Aft, Fundamentals of Industrial Quality Control, 2018
Often the term “quality product” is taken to mean a product that performs at or near perfection. A more practical definition of quality focuses on consistency. A quality product is a product that consistently performs in the expected manner. In most production applications, consistency, producing the product virtually the same way every time, is more important than occasionally producing a perfect product. Consumers develop product expectations based on past performance, and they often change their buying habits when anything happens to change this perception. Potential customers often demand evidence that a product is produced uniformly before they start to use the product.
Teaching system transformation of logistics engineering major from the perspective of smart economy: an empirical study from China
Published in International Journal of Logistics Research and Applications, 2023
Yang He, Weihua Liu, Xiaoran Shi, Peiyuan Gao
Reliability is often used to measure the degree of consistency in measurement results. It usually includes the factors equivalence, stability, and internal consistency, which are generally used in empirical studies. In this study, a Cronbach's alpha coefficient was used for reliability analysis. The range of the coefficient is usually 0–1, with higher values indicating greater internal consistency. In general, a coefficient of 0.9 or above is considered to have excellent reliability, a coefficient of 0.80–0.89 is considered to have good reliability, and a coefficient of 0.70–0.79 is considered to have reliability. The results of the overall reliability analysis for this study are shown in Table 3. The overall coefficient for the question items in the scale is 0.965, which indicates that the scale has excellent reliability.
Business Analytics Capabilities and Decision Quality: The Mediating Roles of Decision Speed and Comprehensiveness
Published in Information Systems Management, 2023
Mamdouh Abdallah Mohamed Abdellatif, A. Mohammed Abubakar, Malek Bakheet Haroun Elayan, Jamal Abdelrahman.M. Hayajneh
Solution consistency and coverage are the two metrics used to quantify fuzzy-set relations. Consistency is the “degree to which cases correspond to the set-theoretic relationships expressed in a solution” (Fiss, 2011, p. 402). Consistency metrics demonstrate the strength of causal conditions in a set relationship like p-values or t-values for statistical inference. Set theory relationships with consistency scores (>0.90) are considered high and acceptable. But the coverage metric “assesses the empirical relevance of a set of causal conditions or factors and/or a range of configurations of causal condition predicting the desired outcome” (Elçi & Abubakar, 2021). Coverage is like the coefficient of determination (R-squared) in classical methods. For the necessary condition(s), coverage is how relevant the condition(s) are to the outcome. For sufficient condition(s), coverage is to what degree a combination of the causal conditions explains a result (Ragin, 2009; Schneider & Wagemann, 2012). In this study, Figure 4 depicts the asymmetric model, and the fsQCA analysis was executed in three steps (See the succeeding paragraphs).
Choosing the system configuration for high-volume manufacturing
Published in International Journal of Production Research, 2018
Yoram Koren, Xi Gu, Weihong Guo
Manufacturing systems should be designed to produce products with consistent quality that meets the product specifications. Although all the parallel machines in the same stage perform the same operations, no two processes are identical due to the small differences in the machines and various types of randomness in the machines and workpieces. As a result, having dimension variations is inevitable. Furthermore, although the variations on each machine are within the tolerances, the variations propagate to the next stage, and continuously accumulate during the processing in the next stages. Therefore, the quality of the final product depends on the precision of all the machines in the route in which the product is processed through in the entire system. In serial lines the product goes through only one processing route. But in RMS the number of processing routes is huge.