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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
After identifying the root cause that led to the nonconformity, you must decide whether a corrective action is necessary. An effective review and evaluation is one that gathers all the relevant information and evaluates it, using the right tools and functions (or roles) to help understand the meaning of the data. This is why the activities and inputs related to the nonconformity must be defined. The inputs for the evaluation include: The review of the nonconformityIdentification of affected devices and recipients of the devicesThe identification and location of the root causeIdentification of all the quality documentation related to the nonconformityIdentification of all regulations, standards, or directives that may set requirements for the reviewEvaluation and analysis of risks affecting other elements, scopes, areas, or functions of the product
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.