Glossary of Terms

21 CFR Part 11 Compliance
The U.S. Food & Drug Administration’s (FDA) code of federal regulations (CFR) for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company’s quality management system and gives guidance for industry best practices.

A2LA 17025 Accreditation
The American Association for Laboratory Accreditation (A2LA) for testing and calibration laboratories that range from the organization, personnel and training, method validations/verification, internal audits, and management review.

Accreditation
Accreditation is the process of officially qualifying a metrology lab to perform inspections. Accreditation is done by an unbiased 3rd-party organization to verify that the lab meets certain standards (e.g., ISO 17025).

AUKOM
Ausbildung Koordinatenmesstechnik or coordinate metrology training in English (AUKOM) is a globally recognized Controlled Measurement Machine (CMM) metrology training program with the international goal of reducing uncertainty and conflict in measurement. All AUKOM CMM training courses are vendor-neutral, allowing you to take the skills that you learn and apply them to any CMM programming software.

BIM Modeling
Building Information Modeling (BIM) can be used for planning, design, construction, and operation of facilities. It helps architects, engineers, and construction companies visualize what is being built in a simulated environment to identify any potential design, construction, and/or operational issues.

Calibration
Calibration is a process that reduces uncertainty by comparing two measurements – one being a standard of known accuracy or value, and one of an unknown accuracy or value. The difference between these two values is then used to achieve an accurate result.

cGMP
Current Good Manufacturing Practice (cGMP) regulations are enforced by the FDA and assure proper design, monitoring, and control of manufacturing processes and facilities.

Cleanroom
Cleanrooms are enclosed spaces where the concentration of airborne particles is controlled and classified. Cleanrooms are designed, constructed, and operated in a manner to control the introduction, generation, and retention of particles inside the room. Levels of other cleanliness are also specified and controlled. Other parameters might also be controlled including temperature, humidity, pressure, vibration, and electrostatic.

Cold Rooms
Cold rooms are spaces where the temperature of the manufacturing process is controlled. Examples of cold rooms include a vehicle test tunnel, where a cold room simulates certain climatic conditions, or in the manufacturing process of medicines such as insulin.

DDC
Direct Digital Control (DDC) enables a single control point for a building’s various systems. DDCs are frequently used to improve efficiency in heating, ventilation, and air conditioning (HVAC), lighting, alarm systems, or in automating an entire building’s system by controlling all electrical and mechanical systems.

Design/Build
Design/build is a project delivery method used by construction companies, architects, and engineers to complete a project more quickly and efficiently. Design/build has one point of contact who oversees all other team members.

Dependability
Dependability is the degree to which a machine or tool is operable and capable of performing its required function at any point in its operating time.

Deviation
Deviation is the difference of an individual data value from the mean (average) of the data set.

Dry Rooms
A dry room is a sealed airtight room that maintains controlled low humidity levels. It is insulated and protected from external contaminants and is designed for accurate, consistent low dew point and temperature control.

EMR Rating
A construction company’s Experience Modification Rating (EMR) is used to gauge its safety metrics. The average EMR is 1.0, and a rating under 1.0 is considered good. Learn more about Precision Environments’ Safety and Quality Program.

FED STD 209E
Enacted in 1992, FED STD 209E was the federal standard for airborne particulate cleanliness classes in cleanrooms. It was cancelled in 2001 and replaced internationally by ISO 14644-1 but is still widely referred to.

Gigafactory
Gigafactories are very large-scale manufacturing facilities that produce batteries for electric vehicles. The term was originally coined by electric car manufacturer Tesla. As an example of size, Tesla’s original Gigafactory has 5.3 million square feet of operational space, the equivalent of 92 football fields.

Histogram
Commonly referred to as a bar graph, a histogram is a visual representation of numerical data.

IEC
The International Electrotechnical Commission (IEC) is an international standards organization that prepares and publishes international standards for all electrical, electronic, and related technologies – collectively known as electrotechnology.

ISO
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. ISO 14644-1 specifies classes of air cleanliness in terms of the number of particles expressed as a concentration in air volume. It also specifies the standard method of testing to determine cleanliness class, including selection of sampling locations.

Metrology
Metrology is the scientific study of measurement of which there are three basic sub-fields: fundamental metrology is concerned with the establishment of units of measurement; industrial metrology is the application of measurement to manufacturing; and legal metrology covers the regulation and statutory requirements for measuring instruments and methods of measurement.

Metrology Laboratory
Metrology Laboratory environments are specially designed to control environmental contaminates that could affect the measurement process including temperature stability, temperature gradients, humidity, air velocity, particulates, pressurization, vibration, EMI/RFI, electrostatic discharge, and acoustics.

Repeatability
Repeatability is the degree to which a measurement tool can do its job repeatedly without losing accuracy.

Tolerance
Tolerance is the minimum and maximum amounts a product is allowed deviate from its ideal form while legally meeting customer requirements.

Turnkey
Turnkey construction is an arrangement in which a contractor designs and constructs a project and delivers it to the owner ready for operation.

Validation
Validation is the act of confirming that a product or service meets the requirements for which it was intended.