The production preparation process is a tool for designing lean manufacturing environments. Hotelling's T2 model: It is known as EN9100 in Europe and JIS Q 9100 in Japan. A European Union (EU) conformity mark for regulating the goods sold within its borders. Definitions in Patient Safety and Quality Improvement: An Overview In this module, you will be reviewing several key terms and tools that are used in patient safety and quality improvement. Fishbone diagram: Refers to ANSI/ISO/ASQ Q9000 series of standards, which is the verbatim American adoption of the 2000 edition of the ISO 9000 series of standards. A method whereby the arduous and labor-intensive task of multiparameter model calibration can be carried out automatically under the control of a computer. BS 7799 Part 3 covers risk analysis and management. Inspection, reduced: Acceptance number: A systematic, independent process of gathering objective evidence to determine whether audit criteria are being met. The critical incident technique is an advanced tool for root cause analysis that can aid in the search for causes through interviews of various people involved in the process in which a critical event occurred. The variation in measurements made by different people using the same measuring device to measure the same characteristic on the same product. Company culture: The system of rules, practices and processes that directs and controls an organization. The current reality tree, conflict resolution diagram, future reality tree, prerequisite tree and transition tree are the five tools used in TOC’s ongoing improvement process. A need or expectation, generally mandatory or compulsory. The person who has responsibility and authority for ensuring that a process meets specified requirements and achieves objectives. A table that graphically presents a large volume of data so the central tendency (such as the average or mean) and distribution are clearly displayed. A high-level automotive process for product realization, from design through production part approval. (The principle was used much earlier in economics and inventory control methods.) The maximum and minimum limit values a product can have and still meet customer requirements. Error proofing: Eighty-twenty (80-20): A philosophy and attitude for analyzing capabilities and processes and improving them repeatedly to achieve customer satisfaction. Situation, Background, Assessment, Recommendation (SBAR) is a verbal or written communication tool that helps provide essential, concise information, usually during crucial situations. Regression analysis: Continuous improvement (CI): Pediatrics in review. 360 Cool Springs Boulevard But there is a prescribed maximum number of samples, after which a decision to accept or reject the lot must be reached. In single sampling, however, the whole sample is usually inspected in order to have an unbiased record of quality history. New! Nagara system: Safety Manager – Provides cost savings and staffing flexibility while ensuring you’re in compliance with safety regulations. A European quality management system standard for the medical device industry. An ASQ certification. A visual representation using a continuous flow line tracing the path of an item or activity through a process. Key process: A term referring to the intent to find and use the best way to perform tasks to improve quality, productivity and efficiency. Generally considered to be the sum of prevention, appraisal, internal and external failure costs. The jidohka system puts faith in the worker as a thinker and allows all workers the right to stop the line on which they are working. Lean: Key process characteristic: A set of goals designed to position an organization to meet future requirements. Requirements: Sampling at random: In acceptance sampling, a plan, intended for application to a continuous flow of individual units of product, that involves acceptance and rejection on a unit-by-unit basis and employs alternate periods of 100% inspection and sampling. Five-phase lean approach: Supplier quality management: Also, English translation of the Japanese word seiketsu, one of the Japanese five S’s (see listing) used for workplace organization. The metric, specification, gauge, statement, category, segment, grouping, behavior, event or physical product sample against which the outputs of a process are compared and declared acceptable or unacceptable. George M. Low was the NASA administrator for nearly three decades. Analyzing the components and process that create a product, with an emphasis on minimizing costs while maintaining standards required by the customer. Four sets of tables were published in 1940: single sampling lot tolerance tables, double sampling lot tolerance tables, single sampling average outgoing quality limit tables and double sampling average outgoing quality limit tables. Customer relationship management (CRM): Operations: A tool that creates frequency distributions. Inspection lot: Also see AS9100. Technical report (TR): Released for the first time in October 1994, an economic indicator and cross-industry measure of the satisfaction of U.S. household customers with the quality of the goods and services available to them. In variables sampling, there are single, double and sequential sampling plans. Validation: Level loading: Laboratory accreditation assesses the capability of a laboratory to conduct testing, generally using standard test methods. External failure: Also see "informative inspection.". This definition … A quality system (for example, 21 CFR, part 58) for labs and organizations to use to ensure the uniformity, consistency, reliability, reproducibility, quality and integrity of testing performed. Qualitician: Process kaizen: See “first pass yield.”. Acceptance quality limit (AQL): A healthcare term for any event that is not consistent with the desired, normal or usual operation of the organization; also known as a sentinel event. The concept that business entities should balance profit-making activities with activities that benefit society. Plan-do-check-act (PDCA) cycle: ANSI/ASQ Z1.4-2003 (R2013): Sampling Procedures and Tables for Inspection by Attributes is an acceptance sampling system to be used with switching rules on a continuing stream of lots for the acceptance quality limit (AQL) specified. Process improvement: A way to prioritize a list of issues, ideas or attributes by assigning points to each item based on its relative importance. Often, a TPA handles the claims processing for an employer that self-insures its employees. Sampling, multiple: The number of units in a sample. It helps businesses use technology and human resources to gain insight into the behavior of customers and the value of those customers. P chart: This includes voice of the customer, value stream mapping, process mapping, capability analysis, Pareto charts, root cause analysis, failure mode and effects analysis, control plans, statistical process control, 5S, mistake proofing and design of experiments. Sort: The practice of grouping machines (such as grinding machines) or activities (such as order entry) by type of operation performed. the Recommendations for Terminology, Abbreviations and Symbols used in the Prescribing and Administration of Medicines in December 2008 for use in all Australian hospitals. Upper control limit (UCL): Basic quality concepts: An ASQ certification; formerly certified mechanical inspector (CMI). It involves screening through unnecessary materials and simplifying the work environment. A control chart for evaluating the stability of a process in terms of the levels of two or more variables or characteristics. Upon successful completion of the audit, the organization receives a certificate indicating it has met the standard requirements. Adverse event: The smallest number of defectives (or defects) in the sample or samples under consideration that will require rejection of the lot. A Japanese strategic planning process in which an organization develops up to four vision statements that indicate where the organization should be in the next five years. Heijunka: Average outgoing quality limit (AOQL): The dissemination of information for taking a specific product from order entry through detailed scheduling to delivery. Percent chart: Quincunxes are often used in classrooms to simulate a manufacturing process. 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