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A2LA - See
below.
Adequacy - In QS-9000, a term used to indicate
that the intent of the standard has been met appropriate to the
scope of the operation.
Aerospace standards - See AS9100
American Association for Laboratory
Accreditation (A2LA) - a nonprofit, non-governmental,
public service, membership society. The mission of A2LA is to
provide comprehensive services inn laboratory accreditation and
training. The organization also certified accrediting
bodies.
American Society for Quality - Measurement
Quality Division (ASQ-MQD)
Analysis of data - Data analysis is necessary to
demonstrate the effectiveness of your quality management
system. In ANSI/ISO/ASQ Q90001-2000, analysis of data is one of
the most important elements (8.4).
ANSI - American National Standards Institute
(ANSI.Org)
AS9100 - SAE
AS9100 is the standard for aerospace manufacturers. It includes ISO
9000 plus additional requirements by the
industry.
ASQ - American Society for Quality (ASQ.Org).
Audit - A systematic, independent and
documented process for
obtaining evidence and evaluating it objectively to determine the
extent to which requirements are being
fulfilled.
Auditee - Organization being
audited.
Auditor - Person(s) performing an audit.
Automotive Standards - Standards for quality
used by automotive industry such as QS-9000 and ISO TS/16949. See also
IATF.
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Baldridge Award (Malcolm Baldridge National Quality Award ) - Annual award
given to U.S. company that excels in quality
management/achievement (also known as
MBNA)
Benchmark Data - The results of an
investigation to determine how competitors and/or best-in-class
companies achieve their level of
performance.
BSI - British Standards Institution.
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Capability- The ability of an organization,
system or process to
realize/produce a product
that will fulfill its requirements.
Cause and Effect Diagram - A graphical statistical
technique used to tie multiple possible causes to a significant
effect that is generally causing a problem.
Characteristic - A distinguishing feature of
an item.
CIM - Computer Integrated
Manufacturing.
Competence - A demonstrated ability;
evidence of applied knowledge or skill.
Compliance - An
affirmative indication or judgment that the supplier of a product or service has met the
requirements of the
relevant specifications, contract, or
regulation; also the state of meeting the requirements.
Component - Any raw material,
substance, piece, part, software, firmware, labeling, or assembly
which is intended to be included as part of a finished product.
Conform - To meet (or conform to) stated requirements.
Conformance - The ability of a product or service to meet (or
conform to) stated requirements.
Conformity - The ability of a product or
service to meet (or conform to) stated requirements. In 9000-2000
the term conformity has replaced the term conformance, although both
are interchangeable regarding definition and acceptable as
description.
Continuous Improvement - Action taken to
find ways in improve processes, decrease variation,
decrease costs, and improve effectiveness of the organization. A requirement under
9000-2000.
Contract review - A contract review is a set
of activities carried out to ensure that all customer orders,
purchase orders or contracts specify all the quality requirements and to ensure
that the organization
can meet these requirements before committing to do
so.
Control Plan - Written description of the
system for controlling parts and processes. Sometimes called a quality
plan.
Correction - Action taken to eliminate a
detected nonconformity
Corrective action - Action taken to remove
the cause of a detected nonconformity or other
undesirable situation. Action(s) designed to identify and eliminate
root causes
of nonconformities (nonconformances). See ISO 9001-2000 clause
8.5.2.
Customers - A customer is anyone who
receives products or services
from the organization.
Customer Satisfaction - Customer's
perception of the degree to which the customer's requirements have been
fulfilled.
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Data - facts, especially numerical facts,
collected together for reference or
information.
Data analysis - Analysis of data is necessary to demonstrate
the effectiveness of your quality management
system. In ANSI/ISO/ASQ Q90001-2000, analysis of data is one of
the most important elements. See ISO 9001-2000 clause
8.4
Defect- Nonfullfillment of a requirement related to
intended or specified use.
Deficiency - (the amount of a) shortfall -
something lacking.
Descriptive statistics - Statistical
techniques used to summarize numerical or quantitative data. Pie charts, bar charts, histograms and scatter plots
are some of the simple graphical methods used to display descriptive
statistics.
Design of experiments - Designed experiments
are used to carry out tests or investigations in a planned manner.
Statistical
techniques are then used to evaluate the data so that conclusions may be
reached with certain levels of confidence. Design of experiments
finds its greatest use in investigating complex system where
outcomes may be influenced by a larger number of
factors.
Design review - A design review is a set of
activities whose purpose is to evaluate how well a potential product (a design) meets all
quality requirements.
During the course of this review, problems must be identified and
solutions must be developed.
Design validation - Design validation is a
process whose purpose is to
examine products and to use objective evidence to
confirm that these products meet user
needs.
Design verification - Design verification is
a process whose purpose is to examine design outputs and to use objective evidence to
confirm that outputs meet input requirements.
Disposition - action of getting rid of or
making over, to arrange, a putting in
order.
Document - Information and its supporting
medium. Document control in ISO 9001-2000 is described in
clause 4.2.3.
Documentation - Objective evidence committed
to writing. Also, supporting medium for compliance such as Manual,
SOPs, Work Instructions, Quality Records, NCMRs, CARs,
etc.
Dominant Element - that element that is most influential
or prominent.
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Element(s) - Elements include
responsibilities, authorities, relationships, functions, policies,
procedures, practices, processes, and resources. Quality system elements
combine to form a quality
system.
Entity - An entity could be a product, process, person, activity,
machine, service, system, department, company, institution, or organization.
Evaluate -To determine the amount or value
of something. To appraise or assess.
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Fishbone Diagram - A problem-solving tool
(statistical
technique) that uses a graphic description of the various process elements to analyze
potential sources of variation, or problems. Sometimes called Cause
and Effect Diagrams.
FMEA (Failure Mode Effects Analysis) - An
analytical technique used to assure that potential failure modes and
associated causes have been considered and addressed.
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Grade - A category or rank given to
different quality requirements for products, processes or systems having the
same functional use.
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HACCP - Hazard Assessment and Critical
Control Point application for food safety. See also ISO 22000
Histogram - A simple graphical statistical
technique used to measure central tendencies and
dispersion.
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top
IATF - The IATF is an ad hoc
group of OEM's and automotive trade associations with a common goal
is to improve the quality of automotive products worldwide. IATF
members include the Big 3 (Ford, Chrysler and GM), along with Fiat,
Citroen, VW, Renault and national automotive trade associations from
the US, Germany, UK, Italy and France. Additionally, the Japanese
vehicle association, JAMA, has been involved with the IATF's efforts
to develop TS
16949.
Identify - To establish who or what a given
person or thing is; to recognize.
IEC - International
Electro-technical Commission.
IEEE - Institute of Electrical and Electronic
Engineers.
Improvement - The action or process of making or becoming
greater; an increase, growth, development or intensification. Also
see continuous
improvement and quality
improvement.
Infrastructure - System of facilities,
equipment and services needed for the operation of an organization.
Inspection - Measuring, monitoring and
testing a product; Observing
and evaluating for conformity.
Interested party - A person or group having
an interest in the performance or success of an organization.
Internal quality audit - Internal audits are audits carried out by
the organization's
personnel. Internal quality audits examine the elements of a quality system in order
to evaluate how well these elements comply with quality system requirements.
International Organization for
Standardization - Developers of the ISO quality
management system standards (ISO.ORG)
Ishikawa Diagram - A problem-solving tool
(statistical
technique) that uses a graphic description of the various process elements to analyze potential
sources of variation, or problems. [Sometimes called Cause and
Effect Diagram or Fishbone Diagram]
ISO - A group of global standards maintained
by the International Organization
for Standardization. ISO is from the Greek Isos, meaning equal.
The purpose of ISO originally was to "equalize" the standard for
quality between the various countries of
Europe.
ISO
8402 - ISO standard that standardizes quality management
and quality assurance vocabulary.
ISO
9000 - A family of ISO standards that apply to quality management
and quality assurance . Specifically, quality
systems.Superceded by ISO/TS
16949.
ISO
Q9000 - Q9000 is the American version of ISO 9000. The
content is the same, the grammar has been Americanized to enhance
understanding. Superceded by ISO/TS 16949.
ISO
9001 - Quality Management System. The worlds most popular
QMS Standard applies to both product and service oriented
companies.
ISO
9004 - The companion document to the ISO 9001 Standard.
Provides Guidance to understanding and implementing (and
self-auditing) the Standard.
ISO
10011 - A family of ISO standards that apply to quality audits
and auditors.
ISO
10303 - Standard for the Exchange of
Product data (See STEP,
below),
ISO
14000 - Series of standards for Environmental
Management
ISO
14001 - Primary standard for Environmental
Management
ISO 15161:2001 - Guidelines on the
application of ISO 9001 for
the food and drink industry (replaced by: ISO
22001).
ISO 22000 is a "hybrid" of the
Quality Management Standard ISO
9001 and HACCP. The ISO 22000 series of Standards applies ISO
9001 and HACCP methodologies to specific food safety
applications.
ISO 22000 - Food safety management
systems - Requirements for any organization in the food chain.
ISO 22001 - Guidelines on the
application of ISO 9001 for
the food and drink industry (replaces: ISO 15161:2001).
ISO TS 22003 - Food safety
management systems for auditing bodies (providing audit and
certification of food safety management systems).
ISO TS 22004 - Food safety
management systems - Guidance on the application of ISO
22000:2005.
ISO 22005 - Traceability in the
feed and food chain - General principles and basic requirements for
system design and implementation.
ISO 22006 - Quality management
systems - Guidance on the application of ISO 9002:2000 for crop
production.
ISO
26000 - The Standard for Social Responsibility. A
guidance document for sustainable business practices. See Social
Responsibility.
ISO/TS 16949:1999 - Automotive standard that
uses ISO 9000:1994 as a
base, but improves upon QS 9000. The standard was developed by the IATF.
ISO TS/16949:2002 - Automotive standard that
supercedes QS-9000 and includes ISO 9001:2000's process
approach. The standard
was developed by the IATF.
ISO/IEC 17025 - Standard for Calibration and
Laboratory Accreditation. With 2005 release added many elements of
ISO 9001, while maintaining
layout of 1999 Standard..
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JIS - Japan
Industrial Standards.
JUSE - Japanese
Union of Scientists and
Engineers.
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Major - In auditing, a nonconformity which is
indicative of a system deficiency that poses immediate hazard to the
product quality. Any nonconformity has to be
corrected prior to obtaining
certification.
Malcolm Baldridge National Quality Award
(MBNA) - Annual award given to U.S. company that excels in quality
management/achievement (same as Baldridge
Award)
Management Review - A periodic review, by
management, of the quality management
system as required by the standard.
Management System - A set of interactive elements (system) to establish a
policy and objectives and to achieve
them.
MBNA - See Baldridge
Award
Minor - In auditing, a finding of nonconformity which is
indicative of a system deficiency, but poses no immediate hazard to
product quality.
Nonconformities have to be rectified within a certain time limit.
Note, a number of minor discrepancies listed against the same requirement can represent a
total breakdown of the system and thus be considered a Major.
Monitor - To observe, supervise, keep under
review; To measure or test at intervals, especially for the purpose
of regulation or control.
MRB - Material review
board.
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NIST - National Institute of Science
and Technology.
Nonconformance - Product or material which does
not conform to the customer specifications and/or requirements. Sometimes used
interchangeably with non-conformity.
Nonconforming product - Product which does not conform
to the customer specifications and/or requirements. Same as NonConformance/Nonconformity.
Nonconformity - When a product, process, procedure, system, or
structure deviates from the ISO requirements; the nonfullfillment of
a requirement.
Nonfulfillment - Failure to fulfill a specified requirement. Sometimes used
interchangeably with nonconformance/nonconformity.
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Objective Evidence - Used in quality audits, objective evidence is
information which can be proven true, based on facts obtained
through observation, measurement, test or other
means.
Organization - The term organization
(in the 2000 standard) refers to you, the unit to which the standard
applies, replacing supplier (in the 1994) standard. The terms used
in ANSI/ISO/ASQ Q9000-2000 to define the supply chain are as
follows:
supplier --> organization -->
customer. Where supplier replaces what was called the
subcontractor in the 1994 standard.
Organizational structure - The pattern of
responsibilities, authorities, and relationships that control how
people perform their functions and govern how they interact with one
another.
Outsource - In ISO 9000-2000, the terms
subcontract and outsource are interchangeable and have the same
meaning.
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Pareto Charts - a graphical statistical
technique used to tally data
in descending or ascending frequency order. They are used to
identify significant areas for investigation.
Parts Per Million - See PPM
PPM - PPM is a way of stating the
performance of a process in terms of actual or projected defective
material.
PFMEA - Process Failure Mode Effects
Analysis- An analytical technique used to assure that potential process failure modes and
associated causes have been considered and addressed. [See FMEA]
Pie
Chart - a simple graphical technique used to show
percentages of a whole, and represent percentages at a set point in
time
Policy - A course of action or principle
adopted or proposed by a government, party, individual, etc.; any
course of action
adopted as advantageous or expedient.
Preservation - An action or an act of
preserving or protecting something; the fact of being
preserved.
Prevention - The action of stopping
something from happening or making impossible an anticipated event
or intended act.
Preventive action - An action taken to
eliminate the cause of a potential nonconformity or other
undesirable potential situation; Action(s) designed to prevent the
occurrence of nonconformities. See ISO
9001-2000 clause 8.5.3
Procedure - Specified way to carry out an
activity or a process.
Quality procedures are used
to control how work should be done, who should do it, and under what
circumstances. Procedures are also used to define responsibility and
authority, which supplies and materials should be used and which documents and records must be
used to carry out the work.
Process - A set of interrelated or
interacting activities, which transforms inputs into outputs.
Processes can be social, industrial, agricultural, governmental,
chemical, mechanical, electrical, and so on. In every case, inputs
are turned into outputs because some kind of work, activity, or
function is carried out.
Process approach - The systematic
identification and management of the processes employed within an
organization, with emphasis on the interactions between such
processes.
Process capability analysis - Analyses used
to examine variability of a process so that an estimate can
be made of its ability to produce product that conforms to requirements.
Process Map - A flowchart used to show the
sequence of processes and how
they tie together.
Product - A product is the result of a process. Products can be
tangible or intangible, a thing or an idea, a service or function, a
concept or creation, etc.
Product Realization - Product realization refers to
the layers of processes that
are used to bring products into being. It is the process of creating a product,
from conceptualization through development. ISO 9001-2000's use of
the term product realization, underscores an important change in
philosophy from a product-centric to process-centric approach.
Product inspection - An activity that
compares one or more characteristics of a product with specified requirements in order to
determine if the product conforms to these
requirements.
Product nonconformity - When one or more
characteristics of a product
fail to meet specified requirements they are
referred to as product nonconformities.
Property - That which one owns; a thing or
things belonging to a person, persons or organization; possessions
collectively; a characteristic possessed by
something.
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QMS - See Quality Management
System
QS-9000 - A set of quality requirements based on ISO
9000, used by the American domestic automobile manufacturers to
register their suppliers. Superceded by ISO
TS/16949.
Qualification - Demonstrating the ability to
fulfill specified requirements.
Quality - The degree to which a set of
inherent characteristics fulfills a requirement.
Quality assurance - The part of quality
management that is focused on providing confidence that quality requirements will be
fulfilled; planned and
systematic activities implemented within the quality system to provide
adequate confidence that requirements for quality will be met.
Quality audits- Quality audits examine the elements of a quality system in
order to evaluate how well these elements comply with quality system requirements. Elements
include responsibilities, authorities, relationships, functions, procedures, processes, and resources.
Elements combine to form a quality system. A
systematic and independent examination to determine quality related
activities are implemented effectively and comply with the quality
systems and/or quality standards
Quality Circle - A group of individuals who
share job responsibilities, that work together to solve quality
problems.
Quality control - That part of quality management
that is focused on fulfilling quality requirements; a set of
activities or techniques whose purpose is to ensure that all quality
requirements are being met and to eliminate any nonconformities.
Quality improvement- A set of activities
whose purpose is to enhance the efficiency and effectiveness of the
organization for the
benefit of both the organization and its customers. ISO 9001-2000
defines quality improvement as part of quality
management focused on increasing the ability to fulfill
quality requirements. Note: The requirements can be related
to any aspect such as effectiveness, efficiency or
traceability.
Quality management - Quality management
includes all the activities that managers carry out in an effort to
implement their quality policy. These activities include quality planning, quality
control, quality assurance, and quality
improvement.
Quality Management System (QMS) -
System used to direct or control an organization with regard to
quality.
Quality manual - A document specifying the
quality
management system of an organization. A quality
manual states your quality policy, quality objectives and describes
your quality system
(which describes the roles, relationships, functions, processes, procedures, systems, and
resources that affect quality).
Quality Objective - Something sought or
aimed for relating to quality.
Quality plan - A document specifying which procedures and associated
resources shall be applied by whom and when to a specific project,
product, process or
contract.
Quality planning - Quality planning is
defined as a set of activities whose purpose is to define quality system policies,
objectives, and requirements, and to explain
how these policies will be applied, how these objectives will be
achieved, and how these requirements will be met.
Quality policy - A quality policy statement
defines your organization's
commitment to quality. The overall intentions and direction of
an organization related
to quality as is formally expressed by top
management.
Quality record - A quality record contains
objective evidence
that shows how well a quality requirement is being met or
how well a quality
system element is
performing. See ISO 9001-2000 clause 4.2.4.
Quality requirement - A quality requirement is a property or
characteristic (quality) that a product or service must have.
For example, a customer may require that a particular product
(entity) achieve a specific dependability score (characteristic).
Quality surveillance - Quality surveillance
is a set of activities whose purpose is to monitor an entity and
review its records to ensure that quality requirements are being
met.
Quality system - A quality system is a
network of processes made up
of elements. Elements include
responsibilities, authorities, relationships, functions, plans,
policies, procedures,
practices, processes, and resources. The purpose of a quality system
is to satisfy quality
management requirements and to assure
that customers receive quality products and services.
Organizational structure, procedures, processes and resources
required to implement quality management
.
Quality System Element - Quality system elements include
responsibilities, authorities, relationships, functions, plans,
policies, procedures,
practices, processes, and
resources. Quality system elements combine to form a quality
system.
Quality System Requirement - A quality is a
characteristic. A system is a set of interrelated elements. And a requirement is an
obligation. Therefore, a quality system requirement is a
characteristic that a systemic element must
have.
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RAB - Registrar Accreditation Board
(U.S.)
Random Sampling - The process of selecting units for a
sample of size, so that all units have an equal chance of being
selected as the sample. In auditing, it refers to how we
obtain objective
evidence.
Range - A measure of the
variation a set of data. It is calculated by
subtracting the lowest value in the data set from the highest value
in that same set.
Reaction Plan - The action
specified by a control plan
when nonconforming product or process instability is
identified.
Record - A document stating results
achieved or providing objective evidence of
activities performed.
Release - Permission to proceed to the next
stage of a process.
Requirement - A need or expectation that is
stated, generally implied or obligatory.
Resource(s) - A resource is a stock or
reserve that can be drawn on when necessary; an available asset.
Resources include people, money, information, knowledge, skill,
energy, facilities, machines, tools, equipment, technologies, and
techniques.
Responsibility - A charge, trust, or duty,
for which one is responsible; a person for whom or thing for which
one is responsible.
Review - An activity undertaken to determine
the suitability, adequacy and effectiveness of the subject matter to
achieve established objectives.
Root Cause - The lowest level cause of a
failure or variation in a product, component, or process
.
Root Cause Analysis - Using one or more
various tools to determine the root cause of a specific
failure.
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SAE - Society of Automotive Engineers (SAE.Org). Responsible for the SAE
AS9100 Aerospace Standard a well as the QS9000 Automotive
Standards.
SAE
AS9100 - SAE AS9100 is the standard for aerospace
manufacturers. It includes ISO 9000 plus additional requirements by the
industry.
Sampling - A statistical
technique (method) for obtaining information about a
characteristic of a large group of data (population) by studying a
smaller representative fraction (sample) of population.
Scope - In your Quality Manual, the Scope
describes all your quality manual (quality management
system) encompasses as well as exclusions to your quality
management system.
Service - Service is a customer-oriented
result. This result is produced when suppliers perform activities
that are oriented towards meeting customer
needs.
Service delivery - Service delivery is a
customer-oriented activity. Service delivery activities are carried
out by suppliers and are oriented towards meeting customer
needs.
Shall - A requirement; a thing that
must be done. Note: "must" may not be used as an alternative to
"shall". (See Directives Part 3-1997, Table
E.1)
Should - A certain course of action is
preferred but not necessarily required.
Six Sigma - A quality process, developed at Motorola,
focused on reducing defects to a six sigma level (3.4 defects per
million; 0.00034%), for all practical purposes
zero defects.
Skill - An ability to do something
(especially manual or physical) well.
Social Responsibility Standard - ISO
26000. A guidance document for sustainable business practices
that defines business as not only providing products and
services that satisfy the customer, but doing so without
jeopardizing the environment, exploiting labor,
etc.
Society of Automotive Engineers (SAE) -
Responsible for the SAE AS9100 Aerospace Standard a well as the
QS9000 Automotive Standards. (See SAE.Org)
SOP - Standard Operating Procedure. Name
generally applied to second-level documentation that describes how
specific work procedures
are performed.
Specification- A document stating requirements
SPC
chart - Statistical Process Control charts graph data obtained from samples drawn
from a process. Data is
processes in sequence. SPC charts show control limits based on the
variability of the process when it is stable. The chart is then used
to detect changes in the process. A Statistical
Technique.
Standard - Often used interchangeably with
(ISO's) requirement. ISO
also uses the term standard to suggest the concept of an
expectation, obligation, requirement, or norm that they want organizations to accept. In
addition, ISO seems to use the term standard to refer to a way of
being or doing things as in the phrase: "this is the standard way we
do this".
Statistical Techniques - An assortment of
methodologies for measurement/modelling of data. Examples include Sampling,
Cause and Effect Diagrams, etc.
STEP
(Standard for the Exchange of Product
data) - otherwise known as ISO 10303, provides a mechanism that is
capable of describing product data throughout the life cycle of a
product, independent from any particular system. The nature of this
description makes it suitable not only for neutral file exchange,
but also as a basis for implementing and sharing product databases
and archiving.
Subcontract - See outsource
Subcontractor - see
Supplier
Suitable - Fit for or appropriate to a
purpose, occasion, person, character,
etc.
Supplier - The term supplier in the 2000
standard replaces the previously used term subcontractor (1994) and
refers to the organization's supplier The
terms used in ANSI/ISO/ASQ Q9000-2000 to define the supply chain are
as follows: supplier --> organization -->
customer. The term organization in the chain refers to
you, the unit to which the standard applies. Note: Suppliers are
sometimes referred to as Vendors. Where differentiation between
supplier types based on ability to affect product quality, Supplier should
be used to describe one who provides "off-the-shelf" product or
services; Sub-contractor to describe one whose product is
incorporated in, or otherwise has potential to affect the the
product quality of, the organization's
product(s).
Supply Chain - The terms used in
ANSI/ISO/ASQ Q9000-2000 to define the supply chain are as follows:
supplier --> organization -->
customer. These replace subcontractor
--> supplier --> customer in the 1994
standard.
Surveillance Audit - A post-registration
quality audit to ensure that the quality system is still
effectively implemented and continuous
improvement is evident.
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Time Series Analysis - See Trend
Analysis.
Total Quality Management (TQM) - A
management approach of an organization centered on
quality.
TQM (Total Quality Management) - A
management approach of an organization centered on
quality
Traceability -The ability to trace the
history, application or location of the item/process under
consideration.
Trend Analysis - Also known as time series
analysis, trend analyses are used for studying observations made
sequentially in time, describing patterns in time series data, detecting a turning point in
a trend, and identifying outliers or extreme
values.
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top
Vendor - used interchangeably with Supplier
and Subcontractor.
Validation - Confirmation, through the
provision of objective
evidence that the requirements for a specific
intended use or application have been
fulfilled.
Verification - Confirmation through the
provision of objective
evidence that specified requirements have been
fulfilled.
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Work Environment - A set of conditions under
which work is performed.
Work Instruction - A third-level document that describes how
work is to be performed. Because sequence of operation on the work
instruction is often compared with what the "operator" actually does
during an audit, this can be an
easy area to uncover nonconformities. Work
instructions should only be used where absolutely necessary.
Training can often be used to eliminate the need for work
instructions.
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