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. |
FDA
|
Food
and Drug Administration of the United States of
America – A governing body that
certifies NNI’s quality system to Federal
Register Quality System Register 21 CFR Part 820. |
ISO
|
International
Organization of Standards – A governing
body that certifies NNI’s quality system
to ISO 13485:2003 and ISO 9001:2000. |
GHTF
|
Global
Harmonization Task Force – A conglomeration
of industry leaders that aid in interpretation
and implementation of the various governing body’s
requirements. |
