Active Optical Cables
(AOC) can be defined as an optical fiber jumper cable terminated with optical transceivers on both ends. It uses electrical-to-optical conversion on the cable ends to improve speed and distance performance of the cable without sacrificing compatibility with standard electrical interfaces. In an active optical cable, electrical input is converted to photons via the combination of a specialized chipset or driver and laser(s). Photons are received at the other end of the cable and converted back to electrical impulses.
The AOI inspection method is an automated visual examination technique that is used to detect flaws in printed circuit board assemblies (PCBAs). The AOI scans PCBAs with cameras and detects two kinds of failures: catastrophic failures, such as missing components, and quality failures, such as misshapen fillet or components that are skewed.
A widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
A collection of individual components put together to create a finished product. This finished product may be ready for the end user or may become part of a larger assembly.
ATPI – Automated Test Platform Solutions
Customizable software and hardware configurations to analyze functionality, performance, and detect system defects.
Automated Optical Inspection (AOI)
An advanced quality control technique to inspect printed circuit boards (PCBs) and electronic assemblies utilizing high-resolution cameras and image processing algorithms to detect defects, such as solder joint issues, component placement errors, and other anomalies.
Automated Pick and Place
A robotic assembly process for accurately and efficiently placing surface mount components onto printed circuit boards (PCBs). It utilizes vision systems and robotic arms to pick components from feeders and accurately position them onto predetermined locations on the PCB, enabling high-speed and high-precision placement, improving manufacturing efficiency, reducing human errors, and ensuring consistent and reliable assembly.
Automated Test Platform Solutions
Customizable software and hardware configurations used to analyze functionality, performance, and detect system defects.
AWG – American Wire Gauge
A standardized wire gauge system created in 1857 that is commonly used throughout the US and Canada to measure conductor size. The AWG shows the conductor’s diameter, conductor area, and resistance per length.
Backshells are an accessory to a connector. Backshells can be round or rectangular based on the shape of the connector and typically are attached to the connector by screw threads or separate screws through connector flanges. Backshells make the transition from a connector to a long length of cable. They can have special features such as the ability to connect a braided metallic shield to provide electromagnetic field protection. They often provide a way to pot (fill with material to seal) and secure in a mold tool that will over-mold a strain relief.
A ball lens is a small lens used in expanded beam fiber optic connectors, enhancing data capacity and optical performance by creating a contactless connection through a tiny air gap. It improves vibration resistance, reduces insertion loss, and increases connector reliability. Nortech's Expanded Beam Xtreme™ platform has six smaller yet high-performing ball lenses, significantly boosting data capacities compared to other expanded beam connectors.
Balun's condition electromagnetic signals emanating from the patient to improve performance by blocking unwanted, common-mode shield currents while passing the differential currents, which deliver noise-free imaging information.
Also known as Ball Grid Array assembly, is an electronics manufacturing technique mounting integrated circuits (ICs) onto printed circuit boards (PCBs) using a grid of small solder balls on the underside of the IC. This method offers numerous advantages, including increased circuit density, improved thermal performance, and enhanced electrical connections, making it well-suited for complex and high-performance electronic devices.
Bill of Materials (BOM)
A comprehensive list of all the raw materials, parts, components, and sub-assemblies required to manufacture a finished product, including the name and description of each item and the quantity needed for each assembly or sub-assembly. The accuracy and completeness of a BOM are critical to ensure efficient manufacturing, avoid production delays, and maintain quality control.
Blind Mateable Connector
An electronic connector designed for mating without visual alignment, often used in cable assemblies requiring unique designs to allow for quick and easy connections in hard-to-reach or limited-access areas. They often utilize a keying or guiding mechanism to ensure correct alignment and mating.
A system integration which assembles a PCB and related components into an enclosure. These assemblies include installing components, sub-assemblies, wire and cable harnesses, and the enclosure.
Bulk cable is a long uncut length of jacketed, shielded, and twisted wires that is used in the production of cable assemblies. Flexibility, flex life, EMI protection, EMP protection, ruggedness, and environmental compatibility are all customizable.
Burn-In & Environment Stress Screening
The process of subjecting components to anticipated environmental stressors such as vibration, pressure, and temperature variations. The testing is completed early in the assembly process to identify simple defects that otherwise may fail soon after the completed assembly’s first use.
A collection of electrical cables or wires protected by a molding or environmental-proof backshell. Used to transmit power and/or signals, these harnesses can range from a simple commercial application to multi-legged assemblies with multiple breakouts and junctions like those used more often for defense, medical, or industrial applications.
The total amount of greenhouse gas emissions, particularly carbon dioxide, released into the atmosphere directly or indirectly as a result of human activities, such as energy consumption, transportation, and production processes. It quantifies the environmental impact of an individual, organization, or product in terms of carbon dioxide equivalents, serving as a measure of their contribution to climate change.
Casted 2-part Molding
A manufacturing process where a liquid resin or plastic material is poured into a two-part mold made of silicone, metal, or thermoplastics. The material is allowed to solidify or cure, and then the mold is opened to remove the finished object or part. Casted 2-part molding is widely used for creating small to medium-sized complex shapes with high precision.
An economic model that aims to keep resources in use for as long as possible through recycling, reuse, and remanufacturing strategies. Waste is minimized through improved design and production processes, and it is seen as a more sustainable alternative to the traditional linear economy, which is based on a "take-make-dispose" model, and is increasingly being adopted by businesses and governments around the world.
An approach to manufacturing that seeks to reduce waste, maximize the use of resources, and minimize environmental impact by designing products and processes that operate in a closed loop. Products are designed for easy disassembly, repair, and reuse, and materials are recycled and reused to the greatest extent possible.
A highly regulated and monitored environment with advanced air filtration, temperature, humidity, and cleanliness controls designed to limit the number and size of particles in the air. Clean rooms are classified based on the permissible particle count per air volume, denoting the maximum number of particles, typically 0.5 mm or larger, allowed per cubic foot, ensuring optimal manufacturing conditions and product quality.
Clinical Hazard Analysis
A systematic method used to identify, assess, and rank hazards. A medical device hazard analysis is a requirement of ISO 14971 risk management, as well as the FDA and other regulatory bodies.
A process of assessing and ensuring adherence to applicable laws, regulations, standards, and policies involving tracking and verifying compliance with safety, environmental, quality, or other regulatory requirements. It typically involves regular reviews and audits to evaluate performance against established criteria and identify improvement areas.
Configuration Management (CM)
Refers to a systems engineering approach for ensuring that a product's performance, functionality, and physical characteristics adhere to its requirements, design, and operational information throughout its life.
A protective layer applied to a printed circuit board (PCB) to insulate and safeguard against harsh environmental conditions, such as moisture and contaminants, improving reliability and longevity. It conforms to the shape of the circuit and its components and is commonly made of silicone, polyurethane, or parylene.
Refers to a computer, program, device, or system's ability to connect with one or more like systems.
Corrective Action Status
The completion percentage or phase of a Corrective Action Plan that has outlined steps addressing process and operation issues and gaps. Draft, In Progress, In Review, and Closed are all potential corrective action statuses.
Costed BOM Analysis
A process that includes reviewing all direct and indirect costs associated with manufacturing an item or assembly, including materials, labor, overhead, shipping, and packaging. This process is an essential part of supply chain management and is used in manufacturing to help negotiate prices with suppliers, track inventory levels, and forecast demand.
The interference of signals between two channels of communication. Intentional crosstalk occurs when two or more devices are paired together and designed to interact. Unintentional crosstalk occurs when two devices, not intended to interact, affect the signal of the other device. Crosstalk can be caused by electromagnetic interference, capacitive coupling, and inductive coupling; and can also enhance or diminish the signal of either device.
The measurement of the amount of data stored on a given medium, which affects transmission speed and capacity, and also affects the number and types of devices that can be connected.
A process that considers a demand forecast (often referred to as an unconstrained forecast) as well as operational and supply chain constraints to develop a Demand Plan dictating what can happen and what should happen to optimize inventory availability, costs, and resource usage.
A collaborative process in which requirements, system performance, test readiness, and other critical factors are reviewed by a cross-functional team, including engineers, management, and the customer. Design reviews usually occur at key milestones in the development process identified by the project management team before the project moves to the subsequent development or production phases.
Design to BOM Incompatibility
Specifying components and layouts that are different from the layout on the printed circuit boards. This can be avoided by following accepted Design for Manufacturability practices.
The stage in product development when the design is transferred from engineering to production to ensure that the production team has all the information and resources necessary to manufacture the product to the required specifications and quality levels. The design transfer process typically involves extensive documentation and communication reducing the risk of errors and delays in bringing new products to market quickly and efficiently.
The process of design verification ensures that the results produced by your designs match the intended inputs.
Device Master Record (DMR)
A collection of information and specifications required by the FDA for commercializing a medical device and includes information on the device's design, manufacturing, testing, quality control, packaging, and labeling. It is used to track the progress of a medical device through its development, production, and marketing and provides information to the FDA in the event of a recall or other problem with the device.
DFM – Design for Manufacturability
The process of design that optimizes the component, parts, or products for ease of manufacturing and to reduce manufacturing costs.
DfSC – Design for Supply Chain
An engineering practice that focuses on leveraging strategies and tactics across the business, from product development and engineering to operations and business intelligence, in order to optimize product designs and entire supply chain networks to drive value for customers and stakeholders. DfSC allows businesses to innovate rapidly by improving agility in responding to changing market conditions.
A class of insulating materials used to separate and electrically isolate conductive components. These materials possess high electrical resistance and low conductivity, allowing them to store and transmit electrical energy without significant loss or dissipation, providing insulation, electrical stability, and protection against short circuits and signal interference.
Dip and Look Solderability Test
The D&L test is a manual technique in which the test object is submerged in molten solder and then visually evaluated.
The Device Master Record is a compilation of documentation for a device, including design specifications and reviews, regulatory documentation, verification and validation, and more. It is released upon product launch.
The practice of involving design, engineering, and manufacturing teams in the product development process as early as possible. This collaboration identifies potential issues early on, saves time and money, improves communication and coordination, leads to a smoother development process, and is seen as a key best practice in today’s competitive marketplace.
Early Supplier Engagement
Refers to involving suppliers in the design and development process as early as possible, allowing for collaboration and feedback, resulting in optimized designs and efficient supply chain processes. Early supplier engagement is crucial since it can lead to cost reduction, accelerated time to market, and enhanced product quality.
Elastomer Transfer Molding
A manufacturing process that produces rubber parts with precise dimensions and excellent surface finish. It involves the transfer of uncured elastomer material from a pressurized pot through a runner and gate system into a heated mold cavity containing a pre-inserted metal or plastic substrate. Under heat and pressure, the elastomer material fills the mold cavity and cures, forming a bonded rubber-to-metal or rubber-to-plastic part. Elastomer transfer molding is commonly used in the automotive, aerospace, medical, and consumer products industries, where the parts require high precision, tight tolerances, and excellent sealing properties.
A term denoting engineering or devices that combine electric and mechanical elements and processes.
The use of electricity in treating disease, particularly electrical equipment used for medical purposes. Examples of electromedical devices include electrical stimulation devices used to relieve pain and MRI machines used for diagnosing illnesses.
EMI (Electromagnetic Interference)
Unwanted electrical noise introduced into a system by an outside source that can cause poor operation, malfunction, or complete system shutdown.
EMS – Electronics Manufacturing Services
A company that provides a wide range of services, including research and development, engineering, supply chain management, production, sales, and distribution for electronic components and assemblies.
EMS Strategic Partner
An EMS provider that integrates into the OEM's supply chain and business operations, collaborating closely, leveraging expertise in engineering, supply chain management, and lifecycle management to drive innovation and achieve shared business goals.
Enhanced Shipping Management
Refers to the optimization and streamlining of the shipping process, including the planning, execution, and monitoring of deliveries, to improve efficiency, reduce costs, and ensure timely and accurate delivery. It involves the integration of various technologies, such as transportation management systems, real-time tracking, and data analysis, to enhance visibility, control, and flexibility in shipping operations.
Enterprise Resource Planning (ERP)
A software system that integrates, organizes and manages some or all of an organization's business activities. This data tracking allows for a real-time, holistic view of financial and operational performance.
ESD (Electrostatic Discharge) Assembly
A protective measure in a printed circuit board (PCB) designed to prevent damage from ESD events which secures sensitive components and maintains reliable operation.
ESG (environmental, social, and governance)
A comprehensive framework and global trend aimed at evaluating and promoting environmentally sustainable practices, social responsibility, and effective corporate governance. It encompasses the integration of green technologies, ethical considerations, employee well-being, community relations, and environmental oversight in assessing a company's overall impact and sustainability performance.
Expanded Beam Xtreme™
An advanced interconnect system developed by Nortech that utilizes fiber optic cabling and increased optical density to provide significant space savings and reliable data transmission in challenging environments. They provide reliable data transmission in harsh environments and are particularly advantageous for medical applications with high mating cycles, as they can tolerate contaminants, offer contactless connections, and enhance reliability by minimizing mechanical wear.
Failure Modes and Effects Analysis (FMEA)
A tool used to identify a system's potential failure modes and evaluate each failure's possible consequences. It is typically used during the design phase of a product or process to identify and assess risk, identify root causes, and develop controls to prevent or mitigate failures.
A conductive path on a printed circuit board connecting internal and external layers, enabling electrical signal transmission. Feedthroughs are commonly implemented as vias, plated through holes, or microvias and used in high-density boards and applications with limited space or high-frequency signals.
Fiber optic cables are communication lines that transmit information as pulses of light through glass or plastic fiber strands (aka: optical fibers, optical fibre) over great distances.
Final Trace Matrix
An industry best practice visualizing the connections between the key design and development activities. The matrix usually begins with how the user's needs translate into design inputs and finish with verification and validation activities.
Fine Pitch Assembly
An advanced electronics manufacturing technique involving the precise placement and soldering of components with tight spacing, typically less than 0.8mm pitch, enabling high circuit density and the production of compact, high-performance electronic devices.
Flat molded cables
Flat molded cable assemblies consist of conductors encapsulated in a flexible rubber material such as polyurethane or silicone in a flat form. Typically one or two layers are laid out parallel into a thin and wide configuration. Molded flat cables are not extruded ribbon cable.
Flex Faraday XtremeTM
A flexible printed circuit for transmitting high-frequency signals while precisely controlling crosstalk and impedance, minimizing electromagnetic interference, improving parallel transmission alignment, and increasing data density.
Flying Probe Test
The flying probe test (FPT) is a system of automated robotic hands that may move in X and Y directions to access all points on the entire PCB and utilize the Z-axis to raise and lower the probe vertically.
A process using historical data, trends, industry insights, and analytics to budget, plan, and estimate business outcomes. Qualitative and quantitative techniques are used to generate a sales forecast, which becomes part of the input to a Demand Planning process.
The size, shape, and other physical attributes required for a connector to physically fit into the mating space.
Fulfillment, also referred to as supply chain management, inventory management, or strategic demand planning, is the process of manufacturing, packaging, and shipping products. A successful fulfillment process requires accurate forecasts and a detailed analysis of supply chain risks to make inventory more readily available to meet supply and demand fluctuations.
Functional tests verify that the product tested operates in the way it was designed.
Hazardous Substance Audit
A systematic evaluation process to identify and assess the presence of restricted or hazardous substances in products, ensuring compliance with relevant regulations and standards. These audits evaluate the supply chain, implement tracking systems, and regularly review compliance status to ensure the elimination of hazardous substances, promoting sustainability and product safety.
Higher-level assemblies are production units consisting of sub-assemblies and components that have been brought together via engineering specifications and design. A higher-level assembly may be used in the production of a product, or it may be an end item itself. The term also refers to the bill of material for such an assembly.
Human Clinical Trials
Research studies in which people volunteer to test new pharmaceuticals, medical devices, or treatments. Trials are conducted in phases, each successive phase designed to provide increasingly strong evidence of the product's safety and effectiveness.
Human Factors Analysis
The study of how people interact with systems, products, and processes to ensure that they are designed to be safe, efficient, and effective. It determines the capabilities and limitations of the users and the system, as well as the environmental and situational factors that may affect their performance and is used to identify potential user errors, assess the risks associated with using a product or system, and inform the design of interventions to mitigate those risks.
A series of technical standards for the essential performance and safety of medical electrical equipment published by the (IEC) International Electrotechnical Commission.
An International Electrotechnical Commission standard specifying life cycle requirements for developing medical software and software within medical devices.
IIoT – Industrial Internet of Things
a subset of the Internet of Things (IoT) that specifically relates to the use of connected devices and systems in industrial settings, such as manufacturing plants, power grids, and oil and gas facilities. The IIoT involves the integration of sensors, software, and connectivity into industrial equipment and processes, which improves efficiency, productivity, and quality in industrial settings by enabling the monitoring and control of processes, equipment, and assets through data-driven decision-making.
The effective resistance of an electric circuit or component to alternating current arising from a combination of ohmic resistance and reactance.
In-circuit tests are performed on a PCBA using a test platform and a custom fixture. These tests measure component parameters and verify correct component-to-component connectivity.
Also known as the Fourth Industrial Revolution, it is the growing trend of automation and data exchange in manufacturing, including developments in artificial intelligence, the Internet of Things (IoT), and the Industrial Internet of Things (IIoT). Industry 4.0 involves the integration of advanced technologies, such as machine learning and robotics, into the design and operation of industrial systems, leading to a new level of efficiency, productivity, and agility.
A widely used manufacturing process for producing parts by injecting molten material, typically plastic, into a mold cavity under high pressure, where it cools and solidifies, forming a finished part. Injection molding is ideal for producing high volumes of small to medium-sized components with complex geometries, precise dimensions, and excellent repeatability. Injection molding offers advantages such as high efficiency, low scrap rates, and the ability to incorporate various design features, such as inserts and over-molding.
The signal power decrease that happens when a component, like a connector or cable, is inserted into a transmission path. Measured in decibels (dB), it indicates the extent of signal strength reduction due to factors such as impedance mismatches, reflections, and absorption, with lower values indicating better signal integrity.
The outermost layer of a cable, providing insulation for the inner components and protection from physical damage and chemical corrosion.
An assembly that uses connection hardware to directly connect a cable to another cable or to an equipment cable in place of a patch cord or jumper, depending upon where it’s used.
IoT – Internet of Things
a network of physical devices, vehicles, buildings, and other objects that are embedded with sensors, software, and connectivity, allowing them to collect and exchange data. The IoT allows these connected devices to communicate with each other and with external systems, such as cloud-based servers, to exchange data and perform tasks.
IP Rating is also known as the International Protection Marking or Ingress Protection Code. It defines the level to which an enclosure for electrical equipment must protect against penetration by dust and liquids.
Requirements published by the International Organization for Standardization for regulatory purposes and is a voluntary standard for designing and manufacturing medical devices.
A nine-part standard that establishes a framework for risk analysis, evaluation, control, and review; and specifies review and monitoring procedures for use during production and post-production.
The internationally recognized standard for Quality Management Systems (QMS). It was first published in 1987 and is the most widely used QMS standard in the world.
International Traffic in Arms Regulations (ITAR) control the export and import of defense-related articles and services on the United States Munitions List (USML).
Jumpers are wires with connector prongs on both ends, allowing them to be used to connect two points without soldering. These wires make it easier to add a circuit as needed and are frequently utilized with breadboards and other prototyping equipment.
An inventory management methodology involving producing, procuring, and delivering inventory only when needed for production. This philosophy focuses on slowly building a stable supply chain to ensure inventory needs are always met while reducing inventory-related costs such as storage, insurance, and obsolescence.
A strategic approach to the planning, design, deployment, and maintenance of resources throughout the development and operational life of a product or process. It looks at the entire development scope, considers how processes will be supported, protected, and adapted over time, and requires proactive planning and collaborative participation among multiple stakeholders.
A technology and engineering discipline that uses optics, communication theory, and digital imaging to develop automated systems that use visual information to guide machines and inspect products for defects, errors, or deviations from predetermined patterns. These systems typically involve using one or more high-resolution cameras connected to specialized image processing boards through specialized cables and are used in various applications, including quality control, manufacturing, and robotics.
The extent to which a product design can be efficiently and effectively manufactured at scale. It encompasses the design's compatibility with manufacturing processes, assembly techniques, and cost-effective production. High manufacturability allows for streamlined manufacturing workflows, reduced production costs, improved quality control, and optimized time-to-market.
Market Release Plan
Part of the reliability documentation included upon validation and launch and after regulatory approvals are obtained, defining how you will introduce the new product or service to potential and current customers.
Metallic shielding can come in many forms and provides protection against both electromagnetic (EMI) susceptibility and emissions. Susceptibility means incoming EMI that can affect Nortech products. Emissions means EMI that goes out to other devices from Nortech products. Shielding is typically comprised of braided metal strands of wire (looks like a Chinese finger trap or maypole braid). Other shielding options include backshells, formed metal sheets, or copper foil to cover gaps.
An electrical cable that transmits radio frequency (RF) signals from one point to another. It consists of an inner conductor surrounded by a dielectric insulation material and an outer shield. The shielding helps to minimize interference from outside sources.
Molded Cable Assemblies
Molded cables have strain reliefs formed between the connector or backshells, which overlap the cable's outer covering (cable jacket). Moldings may also be applied to the portion of the cable where a large section branches out into multiple legs. Molding provides additional pull strength and prevents damage at the flex points near the cable ends. Molding materials may include injection-molded PVC, 2-part mixes of liquid materials that cure into an elastomer, or transfer molded rubber materials that are pushed into a mold through high pressure.
NBC – Nuclear/Biological/Chemical
Refers to weapons or hazardous materials that can cause mass destruction or widespread harm to people and the environment. In a military or emergency response context, NBC typically refers to measures taken to detect, protect against, and respond to potential threats posed by such weapons or materials.
A term that refers to the aim of achieving a balance between negative and positive impacts, and involves reducing negative impacts as much as possible and then offsetting any remaining impact through practices such as recycling or reuse. Net zero can be applied to a range of ESG issues, such as waste, water, diversity and inclusion, human rights, or corruption, resulting in a shift towards more sustainable and responsible practices.
OM3 Fiber Optic Cabling
A type of multimode optical fiber cable specifically designed for high-speed data transmission over short to medium distances. It is optimized to support data rates of up to 10 gigabits per second (Gbps) and offers enhanced bandwidth capabilities compared to standard multimode fiber cables. OM3 cabling is commonly used in data centers, enterprise networks, and other applications where reliable and high-bandwidth communication is required within a limited range.
A measure of the attenuation of light as it passes through a material. It is defined as the logarithmic ratio of the intensity of incident light to the intensity of transmitted light. In engineering, it is commonly used to design and test optical filters, lenses, and other components.
Printed Circuit Boards (PCBs) are rigid, rigid-flex, or flexible laminates consisting of one or more conductive or insulating layers. They are the raw board upon which traces and holes are laid out and components are installed. Once populated with components, it is then referred to as a Printed Circuit Board Assembly (PCBA).
A PCB layout defines the individual components' placement so that they can be easily routed with as few layers as possible. Adhering to DFM practices while creating these layouts can aid in avoiding production delays.
An acronym for Printed Circuit Board Assembly. A blank circuit board after electrical components such as capacitors, resistors, and integrated circuits (ICs) have been added.
The process of filling the space around a printed circuit board (PCB) and its components with a protective, electrically insulating material to guard against physical shock, vibration, moisture, and harsh conditions. The material, typically a two-part epoxy resin, is poured into a mold and cured, creating a solid protective enclosure that improves thermal management.
A design verification process whereby a prototype(s) is built to evaluate the design, accuracy of the documentation, and potential manufacturing issues. This stage usually comes after the design stage and before full-scale production and is used to verify many design aspects, such as material acquisition, assembly methods, software loading, and basic functionality. Various tests may be performed on the pre-production build, including fit and function tests, reliability tests, thermal tests, and electromagnetic compatibility tests.
A record of manufacturing processes, quality control measures, and production schedules ensuring that products are manufactured in a consistent and controlled manner.
Process Validation Protocol
Collecting and evaluating data from the design stage through pre-production to full-scale production establishes scientific evidence that a process can consistently deliver a quality product. A process validation protocol begins with design verification, followed by pre-production build and design to production transfer phases.
Product Lifecycle Management
Product lifecycle management (PLM) is the strategic management of a product's entire journey, from inception to disposal. PLM refers to managing everything connected with a product from start to finish.
The discipline of overseeing and coordinating multiple projects, activities, and resources within an organization to achieve specific strategic goals, from conception to completion, by ensuring that all projects are aligned with the program's objectives, budget, timeline, and quality standards. Effective program management involves breaking down projects into coordinated phases, customized to meet client requirements, and regularly communicating with stakeholders on project status updates.
Project Close-Out Audit
A final review, designed to ensure that all deliverables have been met and delivered according to the agreed upon specifications. It assesses the reliability of the documentation and verifies that corrective actions have also been completed.
A comprehensive document outlining the customer’s requirements as well as the tasks, milestones, deliverables, and resources required to complete the project. It should provide a strategy for managing risks, identifying hazards, and evaluating the effectiveness of risk controls. The manufacturing strategy should also be aligned with the project schedule and should take into account the capabilities of the manufacturing facilities and equipment.
Proof of Concept
A term used to describe a preliminary demonstration or experiment that verifies the feasibility of a concept or idea. It is an early step in the product development process, where a prototype or model is created to test the basic functionality, design, and performance, providing valuable information about the potential for success and any technical challenges or limitations, and guides the development of a more detailed go-forward plan.
PTH – Plated Through Hole
A method for mounting components on a printed circuit board (PCB) by inserting their leads into drilled holes and plating them to make electrical connections between both sides of the board. This provides robust mechanical and electrical connections but takes up more space than Surface Mount Technology (SMT).
The comprehensive approach to ensure consistent quality and performance in an organization's products or services, involving establishing, monitoring, and achieving quality objectives, which encompasses the documentation of processes and responsibilities and the active involvement of team members in problem-solving and continuous improvement. The quality management philosophy emphasizes the importance of fostering a culture of excellence, utilizing relevant metrics, and creating an open environment where feedback and input from all team members are valued and incorporated.
Quality Management System (QMS)
A structured framework that defines and outlines the methods, procedures, and policies for maintaining and improving the quality of products or services within an organization. Vital components of an effective QMS include certifications, documented policies, manuals, procedures, team member training, corrective and preventive action processes, Defective Parts per Million (DPPM) metrics, and ongoing system refinement through continuous improvement practices.
REACH is the Registration, Evaluation, Authorization, and Restriction of Chemicals. This regulation of the European Union was adopted to improve the protection of human health and the environment from the possible risks posed by chemicals while enhancing the competitiveness of the EU chemicals industry. Companies identify and manage the risks linked to the substances they manufacture and market in the EU to comply with the regulation. They have to demonstrate to ECHA (European Chemicals Agency) how the substance can be safely used, and they must communicate the risk management measures to the users. REACH includes a Candidate List of Substances of Very High Concern (SVHC), a Restricted List, and an Authorization List.
Regulatory Body Submissions
Detailed documentation and data submitted to government agencies for obtaining clearance or approval to market a medical device. The submission includes information about the device's design, materials, manufacturing processes, and clinical performance data from preclinical and clinical studies to demonstrate the product's safety, effectiveness, and quality to regulatory authorities and gain approval.
Regulatory compliance refers to the adherence to laws, regulations, standards, and guidelines relevant to a particular industry or product. It ensures that organizations operate within legal and ethical boundaries while minimizing risk to themselves and the public. Achieving regulatory compliance requires thoroughly understanding the relevant regulations and implementing robust compliance processes and controls.
Regulatory Requirements Checklist
A list of technical regulatory requirements as determined during the Planning and Architecture phase of Product Development.
Regulatory standards are the rules and guidelines established by governing bodies to ensure compliance with legal and ethical requirements in developing, manufacturing, and distributing products. They enable customers to trust the quality, safety, and efficacy of products while also ensuring fair competition in the marketplace. Compliance with regulatory standards is essential for companies to operate legally, responsibly, and sustainably in a global economy.
Reliability documentation is a collection of records demonstrating regulatory approvals, clinical evaluations, corrective action status, and risks associated with a given product. The purpose of this documentation is to provide a clear and concise picture of the product's safety and effectiveness and, in many cases, is required to obtain regulatory approval for the sale or use of a product.
Documentation containing definitions of the product's functional, physical, reliability, safety, packaging, and labeling characteristics.
The process of identifying potential threats that could endanger the safety or quality of a product, design, or production method. Analyzing the likely consequences and probability of each risk occurring, the analysis allows design engineers to devise strategies for minimizing these risks as early in the design process as possible and can also lead to better design decisions and mitigation actions when building complex devices and systems.
Risk management identifies, assesses, and mitigates risks throughout the product lifecycle and supply chain. The goal is to identify and control these risks early in the process before they have a chance to impact quality, cost, or delivery timelines.
RoHS is a product level compliance based on the European Union's Directive 2002/95/EC, the Restriction of the Use of Hazardous Substances in Electrical and Electronic Equipment (RoHS). Products compliant with this directive do not exceed the allowable amounts of the following restricted materials: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE), with some limited exemptions. RoHS 3 (EU Directive 2015/863) adds Category 11 products and adds four new restricted substances: Bis(2-Ethylhexyl), Phthalate (DEHP), Butyl Benzyl phthalate (BBP), Dibutyl phthalate (DBP), and Diisobutyl phthalate (DIBP).
RTOS – Real Time Operating System
An operating system designed for applications where timely and predictable responses to events are critical. It prioritizes tasks based on their deadlines and provides deterministic behavior, ensuring that tasks are executed within a guaranteed time frame, and prioritizes the tasks based on their importance, handling them in the order of their deadlines. This makes it ideal for control systems, embedded systems, robotics, and similar time-sensitive systems.
The design and construction of components to withstand harsh operating environments and conditions. This can include protection against shock, vibration, temperature changes, and exposure to moisture, dust, and other environmental factors. Ruggedized devices are built to maintain their performance and function in challenging conditions, making them suitable for military, industrial, and outdoor use.
Shielding is the process of reflecting electromagnetic radiation. The purpose is to protect components and wiring from outside interference and reduce any signal radiating outward from the cable or device.
Signal integrity (SI) is a set of measures that quantify the quality of an electrical signal over long distances, through multiple devices, and under various conditions. Key aspects of signal integrity include transmission speed, ringing, crosstalk, distortion, power supply noise, and signal loss.
An advanced manufacturing facility that uses a range of digital technologies, such as the Internet of Things (IoT), artificial intelligence (AI), and machine learning, to optimize the production process and improve efficiency, productivity, and quality. A Smart Factory aims to create a more agile and flexible production process that can adapt to changing market conditions and customer demands in real time while reducing waste, improving resource utilization, and increasing sustainability.
SMT – Surface Mount Technology
A method of attaching electronic components onto a printed circuit board's surface instead of through holes, resulting in compact, high-density circuits with improved electrical performance, reduced size and weight, and increased production efficiency.
Designing, developing, and maintaining software systems that support and optimize manufacturing processes. It applies engineering principles and methodologies to create reliable, scalable, and efficient software solutions that enhance operational efficiency and enable automation within the manufacturing environment.
Solder Paste Inspection
A process utilizing high-resolution cameras and image processing algorithms to analyze the volume, shape, and alignment of solder paste deposits to verify the accuracy and consistency of these deposits on printed circuit boards (PCBs) before reflow soldering.
Solderability testing is a destructive test used to verify that the solder adheres to the leads adequately. Two typical testing methods are “dip and look” and Surface Mount Process Simulation.
When the customer or some situational incident dictates the specific use of a component or commodity source due to contractual arrangements, tooling considerations, security classification requirements, or other controlling circumstances.
Supply Chain Evaluation
A comprehensive assessment of a company's entire supply chain network, from raw material sourcing to product delivery, and includes analyzing efficiency, risks, and costs and identifying opportunities for improvement. The evaluation process considers factors such as supplier performance, logistics, inventory management, and sustainability, resulting in an optimized supply chain that improves a company's competitiveness, costs, and overall performance.
Supply Chain Evaluation
A systematic assessment and analysis within a supply chain to gauge its efficiency, effectiveness, and overall performance, involving evaluating supplier capabilities, quality control measures, lead times, logistics, cost structures, and overall supply chain resilience. Through this comprehensive evaluation, businesses gain insights to identify areas for improvement, optimize processes, mitigate risks, and enhance collaboration with suppliers.
Supply Chain Management
A supply chain is the network of all the people, organizations, resources, activities, and technology involved in producing and selling a product. A supply chain includes everything from source materials to the manufacturer through end-user delivery.
Supply Chain Risk Management
Supply Chain Risk Management involves implementing best practices to mitigate risks and disruptions in the supply chain, including creating strategic partnerships with suppliers, accurate demand planning, leveling demand fluctuations, understanding product lifecycles, and establishing long-term commitments. By adopting these practices, businesses can achieve improved inventory availability, supplier performance, production planning, cost planning, and revenue actualization.
Surface Mount Process Simulation Solderability Test
Surface mount simulation testing is carried out by screen printing a specific solder paste onto a ceramic plate and then placing the component on top of it, after which you apply a specified convection reflow profile.
System Validation Report
This report confirms that all activities specified in the validation plan have been marked as completed. It summarizes the testing results and provides confirmation that all acceptance criteria have been met and the product is ready for deployment.
Through Hole Auto Insertion (Axial, Radial, DIP)
An automated manufacturing process to attach electrical components to printed circuit boards (PCBs). This process is used for components such as axial resistors, radial capacitors, and dual in-line package (DIP) ICs. Through hole auto insertion offers precise component placement and soldering, ensuring secure and reliable connections between components and PCBs, enhancing manufacturing efficiency, reducing assembly time, and maintaining high-quality standards in electronic products manufacturing.
Tombstoning is a surface mount passive component, such as a resistor or capacitor, that lifts from one pad on one end in the case of a PCB design.
Designing the layout of a PCB’s wiring structure, which defines the copper paths and vias on a PCB.
The action or process of passing on a property, including electrical currents or data signals, or the condition of being transmitted.
Upper Level Assemblies
A combination of board-level and system-level assemblies. A higher level bill of materials structure consisting of components and sub-assemblies.
Vertical manufacturing refers to the integration of a value chain by a producer in order to gain a strategic advantage. Vertical integration is achieved when manufacturers have control or ownership over aspects of a value chain that are beyond the main manufacturing component.
The practice of a company extending its operations throughout its supply chain. A vertically integrated firm will bring previously outsourced activities back in-house. The vertical integration process may be either upstream (backward) or downstream (forward).
A via is a copper connection between printed circuit board layers. A via is a tiny drilled hole that passes through two or more adjacent layers, which is plated with copper to create an electrical link between the copper sheets.
Wire and Cable Harnesses
An arrangement of wires and cables, usually with many breakouts, which have been tied together or pulled into a rubber or plastic sheath, used to interconnect an electrical system.