Glossary
of Validation Acronyms
|
IQ
|
Installation
Qualification – Documented evidence that the equipment has been installed per the manufacturer’s requirements. Often coupled with an OQ. |
OQ
|
Operation
Qualification - Documented evidence that the equipment operates per the manufacturer’s specifications and includes maintenance requirements. Often coupled with an
IQ. |
I/OQ
|
Installation/Operation
Qualification - A compilation of the IQ and OQ, often performed simultaneously on a recently
installed piece of equipment. Also written as IQ/OQ. |
PQ
|
Process
Qualification – Documented evidence that a process will provide predictable results. This is
often a challenge of a given range of process parameters. |
PPQ
|
Product
Performance Qualification – Documented evidence when employing specifically defined operational and manufacturing
criteria that a product can be manufactured repeatedly
and reliably using a qualified process. This qualification
is typically performed over multiple production lots
under a variety of conditions, such as day/night
shifts and/or including tear down and set up of the
process. |
DOE
|
Design
of Experiments – An engineering and statistical tool used to identify critical process parameters,
their acceptable ranges and their interaction with
other process parameters. |
FMEA
|
Failure
Mode and Effects Analysis – A documented analysis developed by a cross-functional team to identify and rank
potential failure modes of a process/product based
upon the severity, rate of occurrence and detectability
of the identified failure modes. |
MSV
|
Manufacturing
Software Validation – Documented evidence that the process specific software used to perform a task
(or multiple tasks) will provide predictable results. |
Gage
R&R
|
Gage
Reliability and Repeatability – A documented blind test performed on a gage using multiple inspectors and samples
to determine the inherent variability in the measuring
technique. |
TMV
|
Test
Method Validation – A validation of an inspection method for a particular application. The TMV may
include multiple gage R&Rs or reference to them. |
DMR
|
Device
Master Record – A document that summarizes all documentation relating to the device, production
process, packaging and labeling specifications, quality
assurance and maintenance procedures and methods. |
DHR
|
Device
History Record – The complete record of all production lots of a particular item. It can also
be the combination of all information of multiple
components making a device or package. In the case
of a single component where the entire production
was made in one production lot, DHR may be synonymous
with Lot History Record. |
LHR
|
Lot
History Record – The compilation of documentation of a particular production lot. The LHR may
include documentation of the processes (the job router),
the material certifications, the certification of
outside processes, the finishing certifications and
the lot inspection records, including in-process
and final inspections and any other quality assurance
documents pertinent to that particular lot. |
cGMP
|
(Current)
Good Manufacturing Practices – The guidelines of the FDA. |
ISO
|
International
Organization of Standards – A governing body that certifies ECO’s quality system to ISO 9001:2015. |
GHTF
|
Global
Harmonization Task Force – A conglomeration of industry leaders that aid in interpretation and implementation
of the various governing body’s requirements. |