- Please visit Acronyms.
Just-in-time Training The provision of training only when it is needed to all but eliminate the loss of knowledge and skill caused by a lag between training and use.
Kaizen Taken from the Japanese words kai and zen, where kai means change and zen means good. The popular meaning is continual improvement of all areas of a company not just quality. (Small, continuous improvements, often using the PDSA cycle.)
Karoshi (Japanese term) Death from overwork.
Laboratory Director Person(s) with responsibility for, and authority over, a laboratory.
Laboratory Manager Person(s) who manage the activities of a laboratory headed by a laboratory director.
Lean A system of methods that emphasize identifying and eliminating all non-value-adding activities. (Tools include, S5: sort, set, shine, standardize, sustain and CANDO: clearing up, arranging, neatness, discipline, and ongoing improvement). An English phrase coined to summarize Japanese manufacturing techniques (specifically, the Toyota Production System).
Licensure The granting of legal permission to provide a specific service by a regulatory body to an organization that meets certain expectations.
Management 1. Coordinated activities to direct and control an organization. 2. See Laboratory Director and Laboratory Manager.
Management Review Evaluation of the overall performance of an organization's quality management system and identification of improvement opportunities. These reviews are carried out by the organization's top managers and are done on a regular basis.
Master Black Belt (MBB) Six Sigma or quality experts responsible for strategic implementations within the business. The Master Black Belt is qualified to teach other Six Sigma facilitators the methodologies, tools and applications in all functions and levels of the company and is a resource for utilizing statistical process control within processes. Matrix A planning tool for displaying the relationships among various data sets.
Metrics A measurement for standard of quality for comparing different items or time periods. You can't improve what you can't measure. Decision makers examine the outcomes of various measured processes and strategies and track the results to guide the company and provide feedback.
MIL-STD-105E A military standard that describes the sampling procedures and tables for inspection by attributes.
Myers-Briggs Type Indicator (MBTI) A methodology and an instrument for identifying an individual's personality type based on Carl Jung's theory of personality preferences.
NCPS VA National Center for Patient Safety Nonconformity A process which does not conform to a quality system requirement.
Nested PDSA Plan, Do, Study, Act Also referred to as "wheel-within-a-wheel," the nested PDSA process involves doing PDSA as part of each PDSA step.
Objective Evidence Data supporting the existence or verity of something.
Occurrence An event, accident or circumstance that happened without intent, volition, or plan.
Occurrence Management A Quality System for detecting, reporting, investigating, tracking, and trending events that do not conform with established policies, processes, and procedures.
Opportunity Statement A concise description of a process in need of improvement, its boundaries, and the general area of concern where a CQI Team should begin its efforts.
Organization Group of people and facilities with an arrangement of responsibilities, authorities and relationships.
Organizational Charts Defines the working structure for the organization; Organizes jobs along lines of authority; Defines reporting structure and span of control; Defines authority to make decisions and accountability for results; Works together with job descriptions to define the working structure of the organization.
Organizational Control The systematic process through which managers regulate organizational activities to make them consistent with the expectations established in plans and to help them achieve all predetermined standards of performance.
Organizational Structure The pattern of responsibilities, authorities, and relationships that control how people perform their functions and govern how they interact with one another.
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Pareto Chart A graphical tool for ranking
causes from most significant to least significant. It is
based on the
Pareto
principle, which was first defined by J. M. Juran in 1950.
The principle, named after 19th century economist Vilfredo
Pareto,
suggests most effects come from relatively few causes; that
is, 80% of the effects come from 20% of the possible causes.
The
Pareto chart is one of the "seven tools of quality."
Path
of Workflow (clinical laboratory) Sequential processes
in preanalytic, analytic, and postanalytic clinical laboratory activities
that transform a physician's order into laboratory information.
PDCA Plan,
Do, Check, Act (Quality improvement tool). A checklist of the four
stages which you must go through to get from `problem-faced' to `problem
solved'.See Deming Cycle.
PDSA Plan, Do, Study, Act
The process of continual quality improvement and learning proposed
by
Walter Shewhart and espoused by W. Edwards Deming. see Nested PDSA. See
Deming Cycle.
PFMEA Process Failure Mode and Effects Analysis. A
Quality improvement tool that emphasizes the importance of actions
that can be taken to eliminate or reduce
the potential causes leading to the process failures.
Poka-yoke Japanese term that means mistake-proofing.
Policy An overarching plan (direction) for achieving an
organization's goals.
Postanalytical Phase (post-examination procedures)
Processes following the examination including systematic review,
formatting and
interpretation,
authorization for release, reporting and transmission
of the results, and storage of samples for the examinations.
One phase of the three-phase framework for the total testing
process to describe issues
related to the quality of laboratory testing.
Preanalytical Phase (Pre-examination
procedures) Steps starting, in chronological order,
from the clinician’s
request and including the examination requisition,
preparation of the patient,
collection of the primary sample,
and transportation to and within the laboratory, and
ending when the analytical examination procedure begins.
One phase of the three-phase framework for the total
testing
process to describe issues
related to the quality of laboratory testing.
Preventative
Action Plan Steps that are taken to remove the causes of
potential nonconformities or to make quality improvements. Preventive actions
address potential problems, ones that haven't yet occurred. In general,
the preventive action process can be thought of as a risk analysis process.
Problem Solving The act of defining a problem;
determining the cause of the problem; identifying, prioritizing
and selecting
alternatives for a solution; and implementing a solution.
Process The use of resources to transform
inputs into outputs. In every case, inputs are turned into
outputs because some kind of work, activity,
or function is carried out.
Process Approach A management strategy used
by managers to control the processes that make up their
Quality Management Systems,
the interaction
between these processes.
Process
Control Concerns all operations of the laboratory, e.g., method
evaluation, validation procedures, standard operating procedures (SOPs),
specimen
management, and quality control.
Process Improvement A systematic and
periodic approach to improving laboratory qualitys,
and the inputs and outputs
that glue these processes together.
It means that they manage by focusing on processes. Read a pdf-linked document about
this topic with glossary-authors, dates
Product Result of a process. (May
be services, software, hardware or processed materials,
or a combination
thereof.)
Proficiency Testing A program
in which multiple samples are periodically sent to
members of a group of laboratories for analysis
and/or identification; whereby each laboratory’s
results are compared with those of other laboratories
in the group and/or with an assigned value, and reported
to the participating laboratories and others. See EQA
Project Unique process, consisting
of a set of coordinated and controlled activities with
start and
finish dates, undertaken to achieve an objective
conforming to specific requirements, including the
constraints of time, cost and resources.
Project Management The application
of knowledge, skills, tools and techniques to a broad
range of activities
to meet
the requirements of the particular project. Project
management knowledge and practices are best described
in terms of their
component processes. These processes can be placed
into five process groups (initiating, planning, executing,
controlling
and closing) and nine knowledge areas (project integration
management, project scope management, project time
management, project cost management, project quality
management, project
human resource management, project communications management,
project risk management and project procurement management).
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Q9000
Series Refers to ANSI/ISO/ASQ Q9000 series of standards,
which is the verbatim American adoption of the 2000 edition of the
ISO 9000 series standards.
Quality Degree to which a set of inherent characteristics
fulfills requirements.
Quality Assurance A planned and
systematic set of quality activities focused on
providing confidence that quality requirements
will be fulfilled.
Quality Audit (also Quality Assessment,
or Conformity Assessment) 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
objectives.
Quality Control A set of activities
or techniques whose purpose is to ensure that all
quality requirements are being met.
Quality Improvement Part of quality
management focused on increasing the ability to
fulfill quality requirements.
Quality Management Coordinated
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. See Quality
System Essentials.
QMPLS Quality
Management Program-Laboratory Services administers
laboratory accreditation in Ontario Canada.
Quality Management Standards (such as ISO 9001:2000 and ISO 15189:2003)
are a series of policy statements. Required statements include the term “shall”.
Full compliance with the standard requires that all “shall” statements
are implemented. Were the laboratory to be inspected to ensure compliance with
the standard, the auditor or inspector would expect to see evidence that each
required “shall” policy was being met. “Shall” statements
are often supplemented by notes or comments that often contain examples or statements
using the term “should”. These statements are intended to give guidance
on what would be considered as reasonable activities, content, or structure to
demonstrate that the “shall” statement is being followed. The organization
is not required to meet all the comments, suggestions or recommendations included
within these notes or commentary.
Quality
Management System Management system to direct and control
an organization with regard to quality.
Quality Manual Document specifying
the quality management system of an organization.
Quality Partnerships Collective group of independent
stakeholders essential for laboratory quality.
Quality Plan Document specifying which
procedures and associated resources shall be applied
by whom and when to a specific project, product, process
or contract.
Quality Policy Overall intentions
and directio n
of an organization related to quality as formally expressed
by top management.
Quality Record Objective evidence
which shows how well a quality requirement is being
met or how well a quality process
is performing. It always documents what has happened in the
past.
Quality Surveillance A set of activities whose
purpose is to monitor an entity and review its records to prove
that quality
requirements are being met.
Quality System The defined organizational structure,
responsibilities, processes, procedures and resources for implementing
and coordinating the Quality Assurance and Quality Control activities.
All aspects of the laboratory operation need to be addressed to
assure quality; this constitutes a quality system.
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.
Quality System Essentials (QSE) The necessary
infrastructure or foundational building blocks in any organization
that need to
be in place and functioning effectively in order to support the
organization’s
work operations so that they proceed smoothly. See Quality Management.
Quality System Review A formal evaluation by management
of the status and adequacy of the quality system in relation to
quality policy and/or new objectives resulting from changing circumstances.
Quality Tools The diagrams, charts, techniques,
and methods that, step by step., accomplish the work of quality
improvement.
Record Document stating results achieved or providing evidence
of activities performed.
Quantification
A process for calculating how much is required of any particular item
supplies for a given period of time.
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