1. Initiate medium FMECA
An FMECA is required either by a specification or by a specific contract for the operation or maintenance of a piece of equipment.
It must be included in the project schedule and resources. It begins in the early phases and continues in the design phase when the components are defined.
You need to define a deadline and the limits of the study (level of precision, questioning, etc.), which must be recorded in a FMEA file.
You'll need to prepare the materials needed to study the system, such as :
its concrete definition which specifies plans, specifications, range... ;
its functional decomposition, which includes a breakdown of the system into sub-assemblies ;
a description of the functions performed...
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Initiate medium FMECA
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Reference standards
ISO 9001:2015 Chapter 8.3.2 Design and development planning
ISO 9001:2015 Chapter 8.3.4 Design and development control
ISO 9001:2015 Chapter 8.5.1 Control of production and service provision
ISO 9001:2015 Chapter 8.5.6 Change control
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