Medical Devices Standards Full Framework

FTA is a top-down, deductive failure analysis technique. It starts with a potential undesired event (the "top event") and uses Boolean logic gates (AND, OR, etc.) to determine the combinations of component failures or human errors that could cause it. It provides a graphical model for understanding and quantifying system risk, identifying critical failure paths.

Passive solar design is a building design strategy that uses a building's components—walls, floors, windows, and orientation—to collect, store, reflect, and distribute solar energy in the form of heat in the winter and reject solar heat in the summer. Unlike active solar heating systems, it does not involve the use of mechanical and electrical devices.

The Buying Center is a model representing all individuals and groups within an organization who participate in a purchase decision. It's not a fixed unit but a set of roles assumed by different people for different purchases. These roles include initiators, users, influencers, deciders, approvers, buyers, and gatekeepers, each impacting the final decision through their specific function and authority.

Total Quality Management (TQM) is a management philosophy where all members of an organization participate in improving processes, products, services, and the culture in which they work. It aims for long-term success through customer satisfaction. TQM integrates quality-discipline into the culture and activities of a company, moving beyond simple product inspection to a holistic, organization-wide approach.

Successful Takt time implementation requires a highly stable production environment. Common challenges include managing machine downtime, ensuring consistent quality to avoid rework, and balancing lines that produce multiple products with different work contents (mixed-model lines). Without addressing these sources of variability, a Takt-driven system can be brittle and fail to meet demand consistently.

Six Sigma is a disciplined, data-driven methodology for eliminating defects in any process – from manufacturing to transactional and from product to service. The statistical representation of Six Sigma describes a process where 99.99966% of all opportunities to produce some feature of a part are statistically expected to be free of defects (3.4 defects per million opportunities).

Parametric modeling is a CAD paradigm where designs are defined by parameters and constraints rather than just geometric shapes. Dimensions and relationships between features (e.g., parallelism, tangency) are stored as parameters. Modifying a parameter value automatically updates the entire model, maintaining the defined constraints. This approach facilitates design iteration, automation, and the creation of design families.

Takt time is a theoretical calculation representing the pace of customer demand (\(Available Time \div Demand\)). In contrast, cycle time is an empirical measurement of the actual time taken to complete one unit of work at a specific process step. A core principle of lean manufacturing is to ensure that cycle time is consistently less than or equal to Takt time.

The use of computer systems to assist in the creation, modification, analysis, or optimization of a design. CAD software allows product designers and engineers to create precise 2D and 3D models, replacing manual drafting. This technology dramatically increases productivity, improves the quality of design, and facilitates better communication through detailed visualizations and simulations.

Solid modeling in CAD represents objects as unambiguous, voluminous 3D shapes. Two primary techniques dominate: Boundary Representation (B-rep), which defines a solid by its bounding surfaces (faces, edges, vertices), and Constructive Solid Geometry (CSG), which builds complex shapes by applying Boolean operations (union, subtract, intersect) to simpler primitive solids like cubes, spheres, and cylinders.

A design methodology where 'X' represents a specific product life cycle objective. DFX encompasses a collection of guidelines and techniques aimed at optimizing a product's design for a particular goal, such as manufacturability (DFM), assembly (DFA), reliability (DFR), or sustainability (DfS). This proactive approach addresses potential issues early in the design phase, reducing costs and improving quality.

To address the inability of different CAD systems to share data, neutral file formats were created. The Initial Graphics Exchange Specification (IGES), developed in the late 1970s, was an early attempt. It was later superseded by the more robust and comprehensive STEP (Standard for the Exchange of Product model data, ISO 10303), which can represent full 3D models, assembly structure, and metadata.

Concurrent engineering, also known as simultaneous engineering, is a design philosophy that emphasizes the parallelization of tasks. Instead of a sequential process where design is completed before manufacturing is considered, it involves a team-based approach where designers, manufacturing engineers, and other stakeholders work together from the outset. This overlap significantly reduces product development time and improves design quality.

The Juran Trilogy, developed by Dr. Joseph M. Juran, is a foundational quality management approach consisting of three interconnected processes: Quality Planning, Quality Control, and Quality Improvement. This framework provides a structured way for organizations to manage for quality. It emphasizes that quality does not happen by accident; it must be planned and managed systematically.

ISO 9001 is the world's most recognized standard for Quality Management Systems (QMS). It provides a framework and a set of principles that ensure a common-sense approach to the management of an organization to consistently satisfy customers and other stakeholders. It is based on seven quality management principles, including a strong customer focus and a process-based approach.