h. Process Capability. This is a process capability a statistical evaluation of a
process to determine its ability to produce output within specified limits. The composite
of all attributes or characteristics, including performance, of an item or product that bear
on its ability to satisfy stated or implied needs.
i. Quality Assurance . Quality assurance (QA) is a planned and systematic
pattern of all actions necessary to provide adequate confidence that management and
technical planning and controls are adequate to:
Establish correct technical requirements for design and manufacturing.
(2) Create products and services that conform to the established technical
j. Quality Audit. A systematic and independent examination and evaluation to
determine whether quality activities and results comply with planned arrangements and
whether these arrangements are implemented effectively and are suitable to achieve
k. Process Audit. This is an analysis of elements of a process and appraisal of
completeness, correctness of conditions, and probable effectiveness.
l. Product Audit. A quantitative assessment of conformance to required
product characteristics. Product quality audits usually involve an inspection operation,
but these are carried out independently of the routine inspection and assessment
m. Quality System Audit. A documented activity performed to verify, by
examination and evaluation of objective evidence, that applicable elements of the
quality system are suitable and have been developed, documented, and effectively
implemented in accordance with specified requirements.
n. Statistical Process Control. This is the application of statistical techniques
to the control of processes and quality. These techniques include the use of frequency
distributions, measures of central tendency and dispersion, control charts, acceptance
sampling, regression analysis, etc.
o. Traceability. The ability to trace the history, application, or location of an
item or activity and like items or activities by means of recorded identification.
Generally, the ability to identify the assembled lots and location of those lots that
contain a particular component.