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These terms are provided to clarify their use in the Framework components, elements, and criteria. Any underlined words within a definition are also defined in the glossary. See the FDA Quality System Framework "Definitions" section for quality system terms.
Accountability - ultimate responsibility for action
Authority - power to command action; right to command or give a final decision (see also: responsibility)
Authorization - approved to take a certain action
Business Process Improvement (BPI) - the process includes awareness, assessment, alignment, action, and accountability to enhance the overall performance to improve productivity, customer satisfaction, and profitability.
Capability - ability of an organization, a system, or process to fulfill requested requirements
Correction - action to resolve specific nonconformance
Corrective action - reactive activity to prevent recurrence of detected nonconformance
Data - facts, especially numerical facts, collected together for reference or information (see also: document)
Defect/deficiency - absence of something necessary for completeness/fitness (see also: nonconformance)
Design and development - a set of processes to transform requirements into product/process characteristics
Deviation - variation from the standard (see also: nonconformance)
Directive - directions to be followed during standard operations; as per FDA SMG 3280.1, a written communication issued in an organized system to establish policy, organization, procedures, or responsibilities; to require action; or to set forth information needed for the effective operation of a system or program. A directive may be a policy memo, procedure, instruction or form. A directive may also be a guidance documents.(see also: document; policy procedure; instruction (see also FDA SMG 3280.1))
Document - (n) information and its supporting medium (see also: data; directive; record); (v) to write down, to provide evidence
Goal - objective or actions related to objective achievements that are quantified and measurable
Instruction - directive on how to carry out a task
Interim guidance -A temporary directive which is applicable for one time only or for a limited period of time.
Lifecycle - the activities that plan, produce, deliver, and service a work product
Management - the managers and supervisors in an organization who lead, direct, and oversee the organization; Senior manager - manager in the top levels of organization with responsibility for strategic direction; Quality manager - a program manager, independent of the unit producing the product, who conducts QA and/or QC activities on unit work products and reports findings to the unit Director.
Measure - determine dimensional or quantifiable metrics; objective evidence used to evaluate a process or performance (see also: monitor)
Metric - specific data selected as an indicator (see also: monitor)
Monitor - watch over; check systematically for the purposes of collecting metrics (see also: measure; trend)
Need - requirement
Nonconformance - an unfulfilled requirement; "nonconformity" is an equivalent term (see also: deviation; defect; corrective action)
Objective - desired achievements derived from policy (strategic or quality); something to be achieved or attempted; to achieve an aim, goal, target (see also: goal)
Organization - The entire FDA or a first echelon component of the FDA whose head reports directly to the Commissioner as per definitions in FDA SMG 1005.1
(PDCA - Plan, Do, Check, Act: a process for quality improvement, also known as the 'Shewhart Cycle' or the 'Deming Cycle'.)
Plan - formulation or organized method by which something is to be done
Policy - a directive setting out a course of action or principle
Preventive action - proactive activity to stop occurrence of a possible nonconformance
Procedure - directive on how to carry out an activity or process
Process - a set of interrelated activities (tasks, procedures, sub-processes) that transform inputs into desired outputs (product) (see also: system)
Project - a process with defined start and finish dates to achieve an objective; 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
Unit - sub-part of an organization
Record - document stating results achieved or providing evidence of activities performed
Requirement - A need or expectation of the customer or other interested party that may be stated, implied, or compulsory resulting in product or process characteristics.
Responsibility - duty, action you are assigned to do; charge, trust, or duty, for which one is responsible (see also: role; authority)
Risk management - process of identifying, evaluating, selecting, and implementing actions to reduce risk to human health and to ecosystems. The goal of risk management is scientifically sound, cost-effective, integrated actions that reduce or prevent risks while taking into account social, cultural, ethical, political, and legal considerations. (see Quality System Framework Reference section, #10)
Role - position or function (see also: responsibility)
Support services - those processes that support daily operations and your product/service delivery but are not usually designed in detail; the support process requirements usually do not depend significantly on product/service characteristics (see Quality System Framework Reference section, #1, p. 47)
System - a set of interrelated or integrated processes to accomplish a purpose
(Task - a piece of work; portion of an activity or procedure (see also: instruction))
Trend (analyze) - review metrics systematically to see if useful behaviors can be deduced from the data relationships (see also: monitor)
FDA Official Councils and Committees Index Page
SMG 2020 - FDA Quality System Framework for Internal Activities