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Measurement, analysis, and improvement
Published in Itay Abuhav, ISO 13485:2016 A Complete Guide to Quality Management in the Medical Device Industry, 2018
The action for dealing with the nonconformity may be realized through repair, rework, swap of products, granting concessions, or rejection. In order to deal with the consequences effectively, you must Determine the scope of the action—In which area of process or product be the action must appliedDefine the objective of the action—What is to be achievedDetermine the needed activities—Which activities are to be undertaken, what the relevant tools and equipment are, what the necessary documentation is, and what the necessary qualifications areEvaluate relevant risks—Assessing further consequences of those actions and which controls are to be setAllocate responsibilities and resources—Who should perform those activities and what resources are requiredAccepting concession—When it is required to concede responsibility for activities that led to the nonconformity
Introduction to Problem-Solving
Published in Maharshi Samanta, Lean Problem Solving and QC Tools for Industrial Engineers, 2019
Before we start our systematic discussion on problem-solving, we need to understand the word conformity in its actual sense. The word “conformity” signifies “compliance” with standards, rules, or laws. It can be a behavior in accordance with an accepted convention. It can also refer to compliance with practices in vogue. This essentially relates to adherence to some expected set of parameters. In effect, if everything follows an expected and desired path, you should not have any concerns. Extending this understanding further, the word having the opposite meaning from conformity is nonconformity. Nonconformity means that something is not complying with, adhering to, or even following a set of standards.
Force-System Resultants and Equilibrium
Published in Richard C. Dorf, The Engineering Handbook, 2018
Nonconformity - Any deviation from standards, specifications, or expectation; also called a defect. Defects or nonconformities are classified into three major categories critical, major, and minor. A critical nonconformity renders a product inoperable or dangerous to operate. A major nonconformity may affect the operation of the unit, whereas a minor defect does not affect the operation of the product.
A non-conformance rate prediction method supported by machine learning and ontology in reducing underproduction cost and overproduction cost
Published in International Journal of Production Research, 2021
Bongjun Ji, Farhad Ameri, Hyunbo Cho
Nonconformity can be defined as the non-fulfilment of a requirement, need, or implicit or obligatory expectation (ISO 9000 2015). It is often used synonymously with defect, which is defined as ‘Non-fulfilment of a requirement related to an intended or specified use’ (ISO 9000 2015). One or more defects in a product can render it nonconforming or unfit for use. A nonconforming product has at least one Critical to Quality (CTQ) characteristic which is outside the required specifications.