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Dictionary

5 WHY – an iterative interrogative technique used to explore the cause-and-effect relationships underlying a particular problem.

Action Tracker – A spreadsheet that helps in managing a project. An action tracker lists the open issues, actions retired, owner responsible for completing that action item and the due date of completion.

CAPA – Corrective and preventive action.  Improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.

Caster – A small wheel attached to the bottom of something, such as heavy piece of furniture, to make it easier to move. (source)

CE Mark – CE marking is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985.[1] The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.

The CE marking is the manufacturer’s declaration that the product meets the requirements of the applicable EC directives.

Concept Generation – The most critical step in the design engineering process. It is a procedure that begins with a set of customer needs and target specifications and results in an array of product concept design alternatives from which a final design will be selected (source)

Continuous Improvement (CI) – A process of manufacturing which is a subsection of just-in-time manufacturing and lean manufacturing encompassing group technology. The goal of cellular manufacturing is to move as quickly as possible, make a wide variety of similar products, while making as little waste as possible.

CSA Mark – CSA International certification marks indicate that a product, process or service has been tested to a Canadian or U.S. standard and it meets the requirements of an applicable CSA standard or another recognized document used as a basis for certification.

Design for Manufacture and Assembly (DFMA) – the process of proactively design products to optimize all the manufacturing functions: fabrication, assembly, test, procurement, shipping, delivery, service, and repair, and assure the best cost, quality, reliability, regulatory compliance, safety, time-to-market, and customer satisfaction (source)

Discovery Team – A cross-functional team involved, prior to the kick-off of a design project, committed to the discovery phase within the pre-stages of product development

Empathetic design – The process of developing an understanding of users, not just their overt needs, but of their constraints, practices, problem-solving approaches, contexts, and the interrelations between people as a whole (source)

Ergonomics (or human factors) – The scientific study of people at work. The goal of ergonomics is to reduce stress and eliminate injuries and disorders associated with the overuse of muscles, bad posture, and repeated tasks. This is accomplished by designing tasks, work spaces, controls, displays, tools, lighting, and equipment to fit the employee’s physical capabilities and limitations (source)

FDA (source)

  • CLASS I – Deemed to be low risk and are therefore subject to the least regulatory controls. Examples include dental floss, enema kits, and elastic bandages.
  • CLASS II – Higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. Examples include powered wheelchairs and pregnancy test kits.
  • CLASS III – Generally the highest risk devices and are therefore subject to the highest level of regulatory control. These devices must typically be approved by FDA before they are marketed. Examples include replacement heart valves, implantable pacemakers, and breast implants.
  • Exempt – If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Examples include manual stethoscopes, mercury thermometers and bedpans.

Fishbone – A cause & effect diagram that identifies possible causes for an effect or problem.

Gemba Walk – Personal observation of work where the work takes place.

High-level assembly – A proven operations strategy that allows OEMs to focus its in-house efforts on the top-level assembly to simplify production, minimize inventory, floor space, manufacturing overhead and direct labor (source)

Human Machine Interface (HMI) – A component of certain devices that are capable of handling human-machine interactions. The interface consist of hardware and software that allow user inputs to be translated as signals for machines that, in turn, provide the required result to the user (source)

IEC 60601-1 – A series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Electrotechnical Commission (IEC) (source)

ISO 13485 – Specified requirements for a quality management where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements set by the International Organization for Standardization (ISO) (source)

ISO 9001 – A set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system (source)

ISTA Packaging Testing – International Safe Transit Association (ISTA) packaging tests are used to assess the security of goods during transport by using vibration, impact, drop and temperature testing. This testing mimics transportation conditions to gauge the likelihood of goods being damaged during transit (source)

Kaizen – Originated from Japanese philosophy that simply translates to “good change”. It is the idea of not focusing on everything all at once, but focusing on small, incremental improvements to make sustainable change

Kanban – A Japanese manufacturing system in which the supply of components is regulated through the use of an instruction card sent along the production line (source)

Lean Processing (Lean Manufacturing) – Manufacturing with the intent of giving customers the most value while using the least amount of resources through the elimination of waste

Needs Analysis – An analysis, within the product development process, assessing a list of “must haves” and “nice haves” to clearly define and prioritize the needs and wants for a project

Original Equipment Manufacturer (OEM) – A manufacturer that makes and resells products or systems to be sold under another company’s brand

Production Part Approval Process (PPAP) – A standardized process in that helps manufacturers and suppliers communicate and approve production designs and processes before, during, and after manufacturing.

Quality at the Source – a lean manufacturing principle which defines that quality output is not only measured at the end of the production line but at every step of the productive process and being the responsibility of each individual who contributes to the production or on time delivery of a product or service

Quick Response Manufacturing (QRM) – A companywide strategy to reduce lead times in all phases of manufacturing and office operations. It can bring your products to the market more quickly and help you compete in a rapidly changing manufacturing arena. It will increase profitability by reducing cost, enhance delivery performance and improve quality (source)

Scope Creep – Loosing direction of a project scope through unnecessary expansion and an excessive volume of changes

UDI Compliance – Complying with the specified UDI requirements set by the FDA.

Unique Device Identification (UDI) – A standardized numbering and traceability system for medical devices to facilitate rapid and accurate identification of a medical device and clearly document the device

UL Listing – UL Listing means that UL (Underwriters Laboratories) has tested representative samples of the product and determined that it meets UL’s requirements. These requirements are based primarily on UL’s published and nationally recognized Standards for Safety. References to UL and the UL Listing may include: the UL Listing Mark.

Waste – Anything the customer is unwilling to pay for including defects, overproduction, waiting, non-utilized talent, transportation, inventory, motion, and extra-processing