SMG 2020 - Attachment A

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

FDA OFFICIAL COUNCILS AND COMMITTEES

FDA QUALITY SYSTEM FRAMEWORK FOR INTERNAL ACTIVITIES

Glossary of Additional Terms

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)