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Accreditation Certification
by a duly recognized body of the facilities, capability, objectivity,
competence, and integrity of an agency, service or operational group
or individual to provide the specific service(s) or operation(s)
needed.
Accident An undesirable or unfortunate event that
occurs unintentionally.
Adverse
Incident 1. An
incident in which harm to a person results from receiving
health care. 2. A
laboratory-based technical adverse incident (TAI) is an event giving
rise to, or having the potential to produce,
unexpected
or unwanted effects involving the safety of patients, users or
other persons. (Note: The investigation of serious adverse events
enables you to learn from experience and, where necessary, train
staff or amend the protocols.)
AFNOR National
Institute of France / Association Francaise
de Normalization
AFNOR is France's national standards-setting organization.
ASQ American
Society for Quality
Analytical
Phase 1. Activities and steps
related to performing laboratory examinations. 2. A set of operations
having
the object of determining the value or
characteristics of a property to describe these processes. 3.
One
phase of the three-phase framework for the total testing process to
describe issues related to the quality of laboratory testing. See
Pre- and Postanalytical.
ANSI American
National Standards Institute.
Audit Systematic, independent and documented process for obtaining audit
evidence and evaluating it objectively to determine the extent to which
audit criteria are fulfilled.
Balanced
Scorecard A management system that which uses financial
data, operational measures,
customer satisfaction, internal processes and the
organization’s innovation and improvement activities. This
allows the monitoring of present performance, but also tries to
capture information
about how well the organization is positioned to perform well in
the future.
Belts A
term used to describe the levels of Six Sigma intense training. Moving
up the belt ladder denotes increased experience and the successful
completion
of courses and projects. See Green Belt, Black Belt, Champion (management
executive), Master Black Belt.
Bias The
difference between the average value of all measurements and the reference
value. A numerical value used to measure accuracy.
Black
Belt (BB) Full-time team leader responsible
for implementing process improvement projects—define, measure,
analyze, improve and control (DMAIC) or define, measure, analyze,
design and verify
(DMADV)—within the business to drive up customer satisfaction
levels and business productivity. See Green Belt. Six Sigma
term.
Brainstorming A group decision-making technique designed
to generate a large number of creative ideas through an interactive
process. Brainstorming
is used to generate alternative ideas to be considered in making decisions. 'thought showers’
BSI British Standards Institute
CAP College of American Pathologists. See
CLIA.
Cause An identified reason for the presence
of a defect or problem
Cause
and Effect Diagram See
Ishikawa Diagram.one of the "seven tools of quality."
Certification The procedure and action by a duly authorized
body of determining, verifying, and attesting in writing to the qualifications
of personnel,
processes, procedures, or items in accordance with applicable requirements.
Champion A business leader or senior manager who ensures
that resources are available for training and projects, and who is
involved
in project tollgate reviews; also an executive who supports and addresses
Six Sigma organizational issues.
Checklist A tool used to ensure all important steps or actions
in an operation have been taken. Checklists contain items important
or
relevant to an issue or situation. See check sheets.
Check Sheet A simple data recording device.
The check sheet is custom designed by the user, which allows
him or
her to readily interpret the
results. The check sheet is one of the "seven tools of quality." See
ckecklist.
CLIA In
the USA, the Centers for Medicare and Medicaid Services (CMS)
regulates all laboratory testing under the Clinical Laboratory Improvement
Amendments (CLIA). Certificate of Accreditation
is issued to a laboratory by approved accrediting organizations such
as CAP, Commission on
Laboratory Accreditation (COLA), and the Joint Commission
on Accreditation of Health Care Organizations (JCAHO).
Closed-loop corrective action (CLCA) A sophisticated
engineering system designed to document, verify and diagnose failures,
recommend and initiate
corrective action, provide follow-up and maintain comprehensive statistical
records.
CLSI Clinical and Laboratory
Standards Institute. Uses consensus process in developing standards.
CLSI
GP26 Application of a Quality Management System Model for
Laboratory Services (Quality document).
CLSI
HS1 A Quality Management System Model for Health Care (Quality
document).
CMPT (Clinical
Microbiology Proficiency Testing Program) A
university-based, Canadian external quality assessment program
for clinical microbiology, mycology, enteric parasitology, and
water testing
laboratories. Estb. 1982. See
EQA.
COLA Commission on Laboratory Accreditation (USA)
Competence Demonstrated
ability to apply knowledge skills.
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.
Conformitè Europeënne Mark (CE Mark)
Conformity European Union mark. The European Union created the
CE Mark to regulate the goods sold within its borders. The mark
represents a manufacturer's declaration products comply with the
EU's New Approach Directives. These directives apply to any country
that sells products within the EU.
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Continual/Continous Improvement The cornerstone
of quality management systems, allows the laboratory to gain insights
from setting objectives, monitoring through audit and management
review, addressing complaints and nonconformities, and performing
client satisfaction surveys. A recurring activity to increase the
ability to fulfill requirements: Plan, Do, Check, Act.
Continuous Quality Improvement (CQI) A philosophy
and attitude for analyzing capabilities and processes and improving
them repeatedly to achieve the objective of customer satisfaction.
Control Chart A chart with upper and lower control limits on which values
of some statistical measure for a series of samples or subgroups are plotted.
The chart frequently shows a central line to help detect a trend of plotted values
toward either control limit.
Controlled Documentation A system for maintaining and ensuring the proper
use of time or version sensitive documents.
Correction Action to eliminate a detected nonconformity.
Corrective Action Plan A plan to eliminate the
cause of a detected nonconformity or other undesirable situation.
Corrective Action Recommendation (CAR) The full
cycle corrective action tool that offers ease and simplicity for
employee involvement in the corrective action/process improvement
cycle.
CQA Certified Quality Auditor.
CQMgr Certified Quality Manager.
Critical to Quality (CTQ) The key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer. CTQs are what the customer expects of a product... the spoken needs of the customer. The customer may often express this in plain English, but it is up to the quality management team to convert them to measurable terms using tools such as FMEA
CSA Canadian Standards Association.
CTQ Critical to quality
Cultural Resistance A form of resistance based on
opposition to the possible social and organizational consequences
associated with change.
Culture Change A major shift in the attitudes, norms,
sentiments, beliefs, values, operating principles and behavior of
an organization.
Customer Organization or person that receives a
product.
Customer Satisfaction Customer's perception
of the degree to which the customer's requirements have been
fulfilled. It can vary from high satisfaction to low satisfaction.
If customers believe that you've met their requirements, they
experience high satisfaction. If they believe that you've not
met their requirements, they experience low satisfaction.
DAP Diagnostic
Accreditation Program in British Columbia. A new accreditation program
is under development by the DAP that will focus on clients and quality
improvement from a systems perspective consistent with the recommendations
made by the newly created Provincial Laboratory Coordinating Office (PLCO).
Deming Cycle for Continuous Improvement A
visualization of the CQI process usually consisting of four
points - Plan, Do, Check, Act -- linked by quarter circles.
The cycle was first developed by Dr. Walter A. Shewhart but
was popularized in Japan in the 1950 by Dr. W. Edwards Deming.
Deming's 14 Principles The foundation of Deming's
philosophy. The points are a blend of leadership, management theory,
and statistical concepts that highlight the responsibilities of
management while enhancing the capacities of employees.
DMADV (Define,
measure, analyze, design and verify)
DMAIC (Define opportunities, Measure performance, Analyze opportunity,
Improve performance, Control performance) A methodology used by Six Sigma.
Document Information
and its supporting medium; digital or physical. ISO identifies five types of
documents: specifications, quality manuals, quality plans, records, and procedure
documents.
Documentation Written
material defining the process to be followed.
DPMO Defects per million opportunities. See Six Sigma.
DRIFT Do It Right the First Time. From Philip Crosby's, Quality
Without Tears (QWT)
published
in
1984.
EA European
national accreditation bodies have joined to form the European
Accreditation (EA) to achieve uniformity of accreditation throughout
Europe as well as internationally working in partnership with the International
Error A
deviation from truth, accuracy or correctness; a mistake; a failure
of a planned action to be completed as intended or the use of
a wrong plan to achieve an aim.
Event An occurrence of some importance and frequently
having antecedent cause.
Examination See Analytical phase, pre- and postanalytical
phase.
External Quality Assessment (EQA) The external
challenge of the effectiveness of a laboratory’s quality
system with samples of known but undisclosed content. It checks
for accurate, timely and clinically useful process output. EQA
is a tool to provide management with an insight into the quality
of the routine laboratory work. See Proficiency Testing.
14
Points W. Edwards Deming's 14 management practices to
help companies increase their quality and productivity.
Facilitator A specifically trained person who functions as a teacher,
coach and moderator for a group, team or organization.
Fishbone Chart See Ishikawa Diagram.
Flowchart A graphical representation of the flow of a process.
A useful way to examine how various steps in a process relate to each other,
to define the boundaries of the process, to identify customer/supplier relationships
in a process, to verify or form the appropriate team, to create common understanding
of the process flow, to determine the current "best method" of performing
the process, and to identify redundancy, unnecessary complexity and inefficiency
in a process.
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FMEA Method (FMECA) Failure Mode and Effect (and Criticality)
Analysis. A tool of risk assessment and failure analysis for use in
risk management and product liability control. The systematic method
of identifying and preventing service, process or product failures
before they occur.
FOCUS-PDSA Find, Organize, Clarify, Understand,
Select—Plan, Do, Study, Act (Quality improvement tool)Form
A paper or electronic document on which information or results
are captured; once completed becomes a record.
Form A paper or electronic document on which information
or results are captured; once completed becomes a record.
Gantt Chart A type of bar chart used in process
planning and control to display planned work and finished work
in relation to time.
Gap
/ GAP Analysis Planning tool used to compare present/current
state with future desired state. Basis for development of action
plans to address high priority gaps. See Spider Diagram.
Green Belt (GB) A business team leader responsible
for managing projects and implementing improvement in his or her
organization. An employee of an organization who has been trained
on the improvement methodology of Six Sigma and will lead a process
improvement or quality improvement team as part of his or her full-time
job. See Black Belt.
Groupthink A situation in which critical information
is withheld from the team because individual members censor or
restrain themselves, either because they believe their concerns
are not worth discussing or because they are afraid of confrontation.
Histogram A graphic summary of variation in
a set of data. The pictorial nature of the histogram lets people
see patterns that are difficult to detect in a simple table of
numbers. The histogram is one of the "seven tools of quality."
Hoshin
Planning (hoshin kanri) The organization-wide strategic
planning system used widely in Japanese companies.
IATA International
Air Transport Association.
ILAC International
Laboratory Accreditation Cooperation See EA.
ILAC-G13:2000 Guidelines for the Requirements for the Competence of
Providers of Proficiency Testing Schemes.
Incident An individual occurrence of brief
duration or secondary importance.
Incident Reporting is the
barometer of risk in an organisation and all health service
quality initiatives stress its importance. See Adverse Incident.
Incremental Improvement Improvements that
are implemented on a continual basis.
Indicators Established measures used to determine
how well an organization is meeting its customers' needs as
well as other operational and financial performance expectations.
Infrastructure Buildings, workspaces, equipment,
hardware, software, utilities, and support services such as transportation
and communication. Inspection Activities,
such as measuring, examining, testing, gaging one or more characteristics
of a product or service, and comparing these with specified requirements
to determine conformity.
Instant Pudding A term used to illustrate
an obstacle to achieving quality or the supposition that quality
and productivity improvement are achieved quickly through an
affirmation of faith rather than through sufficient effort
and education. W. Edwards Deming used this term, which was
initially coined by James Bakken of Ford Motor Co., in his
book Out of the Crisis.
IOM Institute
of Medicine see Healthcare and Quality.
Internal
Audits Internal quality audits are audits carried out
by your personnel that examine the elements of a quality management
system in order to evaluate how well these elements comply with
quality
system requirements.
Internal Quality Control The processes carried
out to check that the laboratory instruments, kits, reagents, calibrators
and equipment are performing within specifications.
Ishikawa Diagram A graphic tool used to explore
and display all the factors that may influence or cause a given
outcome. Developed by Kaoru Ishikawa.
ISO International
Organization for Standardization.
ISO Standards A set of international standards providing
guidance for quality in manufacturing and service industries; developed
to help companies effectively document the quality system elements to be
implemented to maintain an efficient quality system. The standards, initially
published in 1987, are not specific to any particular industry, product
or service; broad applicability, many kinds of organizations can use. The
standards were developed by ISO. See CLSI.
ISO
9001:2000 Standard The most important and internationally
recognized series of standards for Quality Management are referred
to as the ISO 9000 series. The most recent iteration was written
in 2000, and thus is referred to as ISO 9000:2000. A series of
policy statements.
ISO 17025:1999 Standard for testing and calibration
laboratories.
ISO 15189:2003 Standard for medical laboratories. A
series of policy statements.
ISO/IEC Guide 43 Proficiency testing by inter-laboratory
comparisons.
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