Sample glossary

 

Acceptable risk

risk reduced to a tolerable level (see also OHSAS 18 001, 3.1)

Acceptance criteria

the requirements against which a comparison is done to assess conformity

Accident

undesired event causing death or health and environmental damages (see also OHSAS 18 001, 3.9)

Do not confuse accident and incident:

  • an accident is an unexpected serious event
  • an incident is an event that can lead to an accident

Advisory notice

notice on the use, modification, return or destruction of a medical device

Aerospace quality management system

set of processes allowing the achievement of the aerospace quality objectives (see also ISO 9000, 3.2.3)

AFNOR

French association for standardization

Alarm from food origin

information related to food the absence of treatment of which can involve a potentially harmful effect on the health of the consumers

Anomaly

variation compared to what is expected

Do not confuse anomaly, defect, dysfunction, failure, nonconformity, reject and waste:

  • anomaly is a deviation from what is expected
  • defect is the non-fulfillment of a requirement related to an intended use
  • dysfunction is a degraded function which can lead to a failure
  • failure is when a function has become unfit
  • nonconformity is the non-fulfillment of a requirement in production
  • reject is a nonconforming product which will be destroyed
  • waste is when there are added costs but no value

APQP

Advanced Product Quality Planning

AQMS

Aerospace Quality Management System

Asset

any element of value to the organization

Audit

a systematic and independent survey to determine whether activities and results comply with pre-established measures and are capable of achieving the objectives (see also ISO 19011, 3.1)

Do not confuse audit and inspect:

  • to audit is to improve the management system
  • to inspect is to verify the conformity of a process or product

Audit client

Everyone requesting an audit

Audit conclusion

Outcome of an audit (see also ISO 19 011, 3.5)


Audit criteria

everything against which audit evidence is compared (see also ISO 19 011, 3.2)

Audit evidence

demonstrably true data related to audit criteria (see also ISO 19 011, 3.3)

Audit findings

every deviation from audit criteria (see also ISO 19 011, 3.4)

Audit plan

a planned description of activities and means to accomplish an audit (see also ISO 19011, 3.12)

Audit program

planning of audits for a fixed period (see also ISO 19 011, 3.11)

Do not confuse audit program and plan: an audit program is the annual planning of the audits an audit plan is the description of the audit activities

Auditee

everyone who is audited (see also ISO 19 011, 3.7)

Do not confuse audit, auditee and auditor:

  • an audit is the process of obtaining audit evidence
  • an auditee is the one who is audited
  • an auditor is the one who conducts the audit

Auditor

everyone who is trained to carry out audits (see also ISO 19011, 3.8)  

Availability

property of information to be usable in time (see also ISO 27000, 3.7)

Awareness

when people understand their responsibilities and how their actions contribute to the achievement of the organisation’s objectives

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Backup

copy of data in order to archive and protect afainst loss

Benchmarking

comparative analysis method in connection with one or more competitors

benefit

positive impact of the use of a medical device

Brainstorming

method allowing the development of ideas from the participants in order to find solutions

Bulk product

any intermediate product of a process or activity

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Calibration

set of operations allowing the establishment of a relationship between the values shown on the apparatus and the values of a reference standard

Do not confuse calibration and verification:

  • calibration is the confirmation of a value found related to a standard (troy weight)
  • verification is the positioning of reference marks

CCP

Critical Control Point

Certification

written recognition by an independent organization of the conformity of a product, process or organization with requirements established in a standard (see also ISO/IEC Guide 2: 1996)  

Do not confuse certification and accreditation:

  • certification is compliance to requirements of a standard
  • accreditation is the evidence of a specific technical skill to evaluate conformity

Communication

exchange of information  

Do not confuse communicate and inform:

  • to communicate is to pass on a message, listen to the reaction and discuss
  • to inform is to give someone an information

Company

a structure that satisfies a need

Competence

personal skills, knowledge and experiences (see also ISO 19011, 3.10.4)

Compliance obligation

legal and other requirements

Concession (waiver)

written authorization to deliver a nonconforming product (see also ISO 9000, 3.12.5)

Confidentiality

property of information to be accessible only to authorized persons (see also ISO 27000, 3.10)

Conformity

fulfillment of a specified requirement (see also ISO 9000, 3.6.11)

Consequence

result of an event

Contaminant

substance introduced accidentally or deliberately into food (see also Codex Alimentarius, 2.3)  

Do not confuse contaminant and micro-organism:

  • a contaminant is a harmful residue
  • a micro-organism is a dangerous or useful organism

Contamination

presence of undesirable substances in the product

Continual improvement

process allowing the improvement of the global performance of the organization (see also ISO 9000, 3.3.2)

Control

to ensure compliance with the specified criteria (see also General Principles of Food Hygiene, CAC/RCP, 2003)  

Do not confuse control and optimization:

  • control is meeting the objectives
  • optimization is the search for the best possible results
Do not confuse control, inspection and management:
  • control are the activities to get a process or an organization under control
  • inspection are actions on the product, process or material related to requirements
  • management are the activities with regard to personnel

Control measure

process to prevent, eliminate or bring back to an acceptable level a food safety hazard (see also ISO 22 000, 3.7 and Codex Alimentarius, 2.3)


Control plan

document describing the specific measures to carry out the control of a product or process (see also ISO/TS 16 949, 3.1.10)

COQ

costs of obtaining quality

Correction

any action to eliminate or transform a potentially unsafe product (see also ISO 9000, 3.12.3)

Corrective action

action to eliminate the causes of nonconformity or any other undesirable event and to prevent their recurrence (see also ISO 9000, 3.12.2)

Cosmetic product

any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours

Counterfeit part

unauthorized copy, imitation, replacement part or modified part, deliberately presented as an authentic part

Crisis with food origin

collective situation of risk, relating to food, which can create a collective concern

Critical control point

stage at which a control must be applied to prevent, eliminate or reduce a food safety hazard or to bring it back to an acceptable level (see also ISO 22 000, 3.10 and Codex Alimentarius, 2.3)

Critical item

item which requires specific actions to control its effect (see also AS9100D, 3.2)

Critical limit

criterion to determine if a CCP is under control (see also ISO 22 000, 3.11)

Criticality

level of a potential risk

Cryptography

activities of codification and decoding of information

Curative action

action to eliminate a detected nonconformity


Customer

anyone who receives a product (see also ISO 9000, 3.2.4)  

Do not confuse customer, supplier and subcontractor:

  • a customer receives a product
  • a supplier provides a product
  • a subcontractor provides a service or a product on which a specific work is done

Customer satisfaction

top priority objective of every management system (see also ISO 9000, 3.9.2)

CWQC

Company Wide Quality Control  

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Defect

nonconformity related to a specified use (see also ISO 9000, 3.6.10)

Detection

level of identification of a failure by a means

Deviation

failure to meet a given threshold (see also Codex Alimentarius, 2.3)

Do not confuse deviation and problem:

  • a deviation is the non respect of a threshold
  • a problem is a variation which should be reduced (to obtain a result)

Device

every product, component or system which can be examined as a unit (see also IEC 60 812, 3.1)

Document

any support allowing the treatment of information (see also ISO 9000, 3.8.5)

Documented information

any support allowing the treatment of information

Dysfunction

element disturbing the operation of a process  

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Effectiveness

capacity to perform planned activities with minimum effort (see also ISO 9000, 3.7.11)  

Do not confuse effectiveness and efficiency:

  • effectiveness is the level of achievement of planned results
  • efficiency is the ratio between results and resources

Efficiency

financial relationship between achieved results and resources used (see also ISO 9000, 3.7.10)

EMS

Environmental Management System

End product

any final result of a process or an activity (see also ISO 22 000, 3.5)

Environment

space in which any organization functions (see also ISO 14 001, 3.5)

Environmental aspect

every element of an organization that interacts with the environment (see also ISO 14001, 3.2.2)  

Do not confuse environmental aspect and impact:

  • aspect is the element which reacts with the environment
  • impact is the change of the environment following an aspect

Environmental impact

every change in the environment caused by an organization (see also ISO 14001, 3.2.4)

Environmental management system

set of processes allowing the achievement of the environmental objectives (see also ISO 14001, 3.1.2)


Environmental objective

environment related, measurable goal that must be acheived (see also ISO 14001, 3.2.6)

Environmental performance

measurable results of the environmental management system (see also ISO 14001, 3.4.11)

Environmental policy

statement by top management allowing the establishment of environmental objectives (see also ISO 14001, 3.1.3)

Error

actions or omissions leading to results that were neither foreseen or intended

External provider

an entity that provides a product (see also ISO 9000, 3.2.6)

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FA

functional analysis

Factual approach

decisions are made using reliable data and information and valid analysis methods (see also ISO 9004, Annex B.8)

Fail safe device

system allowing the prevention of errors by eliminating the human factor (see also IATF 16949, p. 13; "Poka-Yoke" in Japanese)

Failure

variation of aptitude of a functional unit to satisfy a specified function (see also IEC 60 812, 3.2)

Failure effect

consequence of a failure mode (see also IEC 60 812, 3.4)

Failure mode

way in which a product or system deviates from a specified function (see also IEC 60 812, 3.5)

FEFO

Fisrt expired, first out


FIFO

First in, first out


Finished product

any end result of a process or activity

First article inspection

Aerospace product approval activities (see also EN 9102, 3.5)

Flow diagram

picture of a process that shows the steps performed and their interactions (see also ISO 22 000; also called flowchart)

Flowchart

picture of a process that shows the steps performed and their interactions (see also ISO 22 000; also called flow diagram)

FMEA

Failure Mode and Effects Analysis

FMECA

Failure Mode, Effects, and Criticality Analysis  

Do not confuse follow-up and review:

  • follow-up is the verification of the obtained results of an action
  • review is the analysis of the effectiveness in achieving objectives

Food

every product intended for nourishment (see also Reglement CE N° 172, 2002)

Food hazard

potential harmful effect of a biological, chemical or physical nature on people's health following the consumption of food (see also ISO 22 000, 3.3)  

Do not confuse food hazard and risk:

  • hazard is a potential harmful effect coming from food
  • risk is the level of occurrence and the severity of the hazard on the consumer

Food hygiene

means and conditions to control food hazards and to guarantee the food safety and suitability (see also Codex Alimentarius, 2.3)

Food risk analysis

methodical analysis of the existence of a hazard to understand its nature and to facilitate the adoption of control measures (see also Codex Alimentarius, 2.3)

Food safety

absence of harm to the consumer when food is prepared or consumed according to its intended use (see also ISO 22 000, 3.1 and Codex Alimentarius, 2.3)  

Do not confuse food safety and suitability:

  • safety is the absence of damage for the consumer
  • suitability is what is acceptable for the consumer

Food safety management system

set of processes allowing the achievement of the food safety objectives


Food safety manual

document stating the general measures of an organization to obtain safe finished products

Food safety policy

statement by top management allowing the establishment of food safety objectives (see also ISO 22 000, 3.4)

Food suitability

assurance that food when consumed in accordance with the intended use is acceptable for consumption (see also Codex Alimentarius, 2.3)

Food traceability

property to memorize or restore the history or the trace of food (see also CE 178/2002 and ISO 22 005, 3.6)


FS

Food Safety

FSMS

Food Safety Management System

Functional analysis

studies of the functions of a product or system in relation to its environment (see also NF X50-151)  

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Good manufacturing practice

all the necessary preventive activities for food production under acceptable hygienic conditions

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HACCP

Hazard Analysis Critical Control Point. System for the control of the hazards yhat threaten food safety (see also Codex Alimentarius, 2.3)

HACCP method

tool of reasoning that makes it possible to identify, evaluate and control the food safety hazards

HACCP plan

planned description of the procedures and means to ensure the control of food hazard safety (see also Codex Alimentarius, 2.3)

HACCP system

the HACCP plan and the prerequisite programs for the control of food safety

Harmlessness

quality of what is not harmful to health

Hazard

situation that could lead to an incident (see also OHSAS 18 001, 3.6 and Codex Alimentarius, 2.3)  

Hazard analysis

way to determine the hazards and to establish the critical controls so as to guarantee food safety  

Do not confuse hazard and risk:

  • the hazard is the state, the situation, the source which can lead to an incident
  • the risk is the measure, the result of a hazard

 

Do not confuse hazard and risk analysis:

  • hazard analysis is the responsibility of participants in the food chain
  • risk analysis is of the public health domain

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IMS

Integrated Management System

Incident

undesired event that could lead to health damages (see also OHSAS 18 001, 3.9)

Incident (information security)

unwanted and unexpected event that can compromise information security (see also ISO 27000, 3.31)

Indicator

value of a parameter, associated with an objective, allowing the objective measure of its effectiveness (see also FD X50-171, 2.1)  

Do not confuse indicator and objective:

  • an indicator is the information on the difference between the achieved result and the preset objective
  • an objective is a sought after commitment

Information security

controls to protect the confidentiality, integrity and availability of information (see also ISO 27000, 3.28)

Information security management system

set of processes allowing the achievement of the information security objectives

Inspection

the actions of measuring, testing and examining a process, product or material to establish whether requirements are met (see also ISO 9000, 3.11.7)

Intégrity

property of information to be unaltered (see also ISO 27000, 3.36)

Interested party

person, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3)

IS

information security

ISMS

information security management system

ISO

International Organization for Standardization  

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JIT

Just In Time   M

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Key characteristic

attribute which can require specific actions to manage its variation (see also AS9100D, 3.3)

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Legal watch

collection and permanent use of statutory and regulatory information

Level of risk

criticality of risk by impact and likelihood (see also ISO Guide 73, 3.6.11.8)

Likelihood

possibility that something happens (see also ISO Guide 73, 3.6.1.1)

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Management by quality

activities with quality as first priority


Management review

a periodic survey carried out by top management of the management system for its continual improvement

Management system

set of processes allowing objectives to be achieved (see also ISO 9000, 3.5.3)


Manager

someone who gets results through other people

MCT

Multiple-choice Test

Medical device

product or service to be used for purposes of diagnosis, prevention, monitoring, treatment, alleviation of disease or injury

Micro-organism

living organism of microscopic size, dangerous or useful (microbe, bacterium, virus, yeast)

Mistake

wrong action done correctly or incorrectly

Monitoring

pack of planned actions to guarantee the effectiveness of control measures (see also ISO 22000, 3.27)

MTBF

Mean Time Between Failures  

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Nonconformity

non-fulfillment of a specified requirement (see also ISO 9000, 3.6.9)  

Nonquality

gap between expected quality and perceived quality

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Objective

measurable goal to be achieved

Objective evidence

demonstrably true factual data (see also ISO 9000, 3.8.3)

Occupational health and safety

everything that can influence the wellbeing of the personnel in a company (see also OHSAS 18 001, 3.12)

Occupational health and safety management system

set of processes allowing the achievement of the occupational health and safety objectives (see also OHSAS 18 001, 3.13)

Occupational health and safety policy

statement by top management allowing the establishment of occupational health and safety objectives (see also OHSAS 18 001, 3.16)

Occurrence

frequency or probability of the appearance of a failure or an event

ODT

Open and Distance Training

OH&S

Occupational health and safety

OH&SMS

occupational health and safety mamagement system

Operational prerequisite program (oPRP)

set of essential processes and conditions guaranteeing the control of the probability of the introduction, contamination or proliferation of food safety hazards (see also ISO 22 000, 3.9)

Opportunity

uncertain event that may have a favorable impact

oPRP

operational prerequisite program

Organization

a structure that satisfies a need (see also ISO 9000, 3.2.1)  

Do not confuse organization and enterprise, society, company:

  • organization is the term used in the standard ISO 9001 as the entity between the supplier and the customer
  • an enterprise, society and company are examples of organizations

  Do not confuse organizational chart and process map:

  • the organizational chart is the graphic display of departments and their links
  • the process map is the graphic display of processes and their interaction

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PDCA

Plan, Do, Check, Act

Performance

measurable and expected results of the management system (see also ISO 9000, 3.7.8)

PEST

Political, Economic, Sociological, Technological. Analysis to identify the influence of external factors

Poka-Yoke

see Fail safe device

Poor quality

see nonquality

Potential cause of failure

circumstance capable of leading to a failure

PPAP

Production Part Approval Process

Predictive maintenance

group of planned forecast actions to avoid likely failures of the equipment (see also IATF 16949, p. 15)

Do not confuse predictive and preventive maintenance:

  • predictive maintenance avoids the potential dysfunctions by forecast analysis
  • preventive maintenance avoids the unforeseen dysfunctions by regular maintenance

Prerequisite program (PRP)

set of processes and conditions guaranteeing safe finished products for the consumer (see also ISO 22 000, 3.8)

Preventive action

action to eliminate the potential causes of nonconformity or any other undesirable event and to prevent their appearance (see also ISO 9000, 3.6.4 and ISO 14 001, 3.17)

Preventive maintenance

group of planned prevention actions to maintain the equipment in perfect state and provide specified service (see also IATF 16949, p. 15)

Problem

the distance that has to be overcome between the real and the desired situation

Procedure

document describing the to carry out a process (see also ISO 9000, 3.4.5 and documented information)

Process

activities that transform inputs into outputs (see also ISO 9000, 3.4.1)

Do not confuse procedure, process, product, activity and task:

  • a procedure is the description of how we should conform to the rules
  • a process is how we satisfy the customer using people to achieve the objectives
  • a product is the result of a process
  • an activity is a set of tasks
  • a task is a sequence of simple operations

Process approach

management by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency (see also ISO 9001, 03)

Product

any outcome of a process or activity (see also ISO 9000, 3.4.2)

Product (or service)

any outcome of a process or activity (see also ISO 9000, 3.7.6)

Product safety

the state in which a product is capable of achieving its purpose without causing an unacceptable risk of harm to persons or property

PRP

prerequisite program

PSW

Part Submission Warrant  

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QC

Quality control

QCD

Quality, Cost, Delay

QM

Quality Manual

QMS

Quality Management System

QSE

Quality, Safety, Environment

Quality

aptitude to fulfill requirements (see also ISO 9000, 3.6.2)

Quality approach

set of continual improvement activities to achieve the objectives of quality policy

Quality management

activities allowing the control of an organization with regard to quality (see also ISO 9000, 3.3.4)

Quality Management System

set of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4)


Quality manager

leader of the journey towards excellence

Quality manual

document specifying the general measures taken by an organization to obtain conforming products or services (see also ISO 9000, 3.8.8)

Quality objective

quality related, measurable goal that must be achieved (see also ISO 9000, 3.7.2)

Quality plan

document specifying the methods, means, responsibilities and stages of activities related to quality, applied specifically to a product, project or process (see also ISO 9000, 3.8.9)

Quality policy

statement by top management allowing the establishment of quality objectives (see also ISO 9000, 3.5.9)  

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Recall

measure preventing the consumption of unsafe food after distribution or sale (see also Directive 2001/95/CE)

Do not confuse recall and withdrawal:

  • recall is a measure to prevent consumption after distribution
  • withdrawal is a measure to prevent distribution

Record

document providing objective evidence of achieved results (see also ISO 9000, 3.8.10 and documented information)

Regulatory watch

collection and permanent use of statutory and regulatory information

Reject

treatment of an unrecoverable product

Requirement

explicit or implicit need or expectation (see also ISO 9000, 3.6.4)

Residual risk

accepted risk (see also ISO Guide 73, 3.8.1.6)

Responsibility

capacity to make a decision alone

Review

survey of a file, product, process so as to verify whether preset objectives are achieved (see also ISO 9000, 3.11.2)

Risk

likelihood of occurrence of a threat or an opportunity (see also ISO Guide 73, 1.1)

Risk appetite

quantity and type of opportunity to seize or risk to take (see also ISO Guide 73, 3.7.1.2)

Risk assessment

risk identification, analysis and evaluation process (see also ISO Guide 73, 3.4.1)

Risk management

activities to restrict the possibility that something goes wrong (see also ISO Guide 73, 2.1)

Risk management system

set of processes allowing the achievement of the risk objectives (see also ISO Guide 73, 2.1)

Risk policy

statement by top management allowing the establishment of risk objectives (see also ISO Guide 73, 2.1.2)

Risk prevention

activities based on decreasing risk likelihood of occurence

Risk protection

activities based on reducing risk impacts

Risk treatment

risk modification activities (see also ISO Guide 73, 3.8.1)

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Safety

aptitude to avoid an undesired event

Sanitary quality

aptitude to satisfy and guarantee an optimal food safety

Service

See Product

Severity

level of perception of a failure by the customer

SMART

Specific, Measurable, Achievable, Realistic, Time-bound

SMED

Single Minute Exchange of Die

SPC

Statistical Process Control

Special characteristic

characteristic of a product or process which could affect the safety of the product or compliance with regulation or could decrease customer satisfaction (see also IATF 16949, p. 16)

Special requirement

requirement at the limit of its technical capabilities (see also AS9100D, 3.5)

Specification

final description of system or product requirements in order to develop or validate it (see also ISO 9000, 3.8.7)

Stakeholder

person, group or organization that can affect or be affected by a company (see also ISO 26000, 2.20)

Statement of Applicability

document describing the objectives and security controls

Strategy

total approach to achieve objectives (see also ISO 9000, 3.5.12)

Do not confuse goal, mission, purpose, strategy and vision (its always reasons for existence):

  • a goal is to make money on the long term
  • a mission is how to realize its vision
  • a purpose is to meet the identified requirements
  • a strategy is a plan to achieve its objectives
  • a vision is what we want to become in the long run

Supplier

an entity that provides a product (see also ISO 9000, 3.2.5)

SWOT

Strengths, Weaknesses, Opportunities, Threats. Tool for structuring a risk analysis

System

set of interacting processes (see also ISO 9000, 3.5.1)

System approach

management of a set of interacting processes to be able to achieve organizational objectives (see also ISO 9004, Annex B.6)

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TC

Technical Committee

Threat

uncertain event that could have a negative impact on the objectives

Top management

group or persons in charge of the organizational control at the highest level (see also ISO 9000, 3.1.1)

TQC

Total Quality Control

Traceability

the aptitude to memorize or restore all or part of a trace of executed functions (see also ISO 9000, 3.6.13)

Trust

believe in something common

TS

Technical Specification  

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VA

Value Analysis

Validation

confirmation that the application of a process, product, service or material allows expected results to be achieved (see also ISO 9000, 3.8.13)  

Do not confuse validation and verification:

  • validation is to approve compliance
  • verification is to review compliance

Validation (food)

establishment that application of the FSMS is compliant (see also ISO 22 000, 3.15 and Codex Alimentarius, 2.3)

Value analysis

method of optimization of a product or system intended to satisfy user's needs

Verification

the periodic inspection survey of compliance of a process, product or material (see also ISO 9000, 3.8.12)  

Verification (food)

periodic inspection survey of compliance of the FSMS (see also ISO 22 000, 3.16 and Codex Alimentarius, 2.3)

Verification (metrology)

set of operations allowing the positioning of a reference mark on a measuring apparatus

VLAN

Virtual Local Area Network

Vulnerability

weakness of an asset that could lead to unauthorized access (see also ISO 27000, 3.77)

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Waste

anything that adds cost but no value

Withdrawal

measure preventing the distribution or the sale of an unsafe food (see also Directive 2001/95/CE)

Work environment

set of human and physical factors in which work is carried out (see also ISO 9000, 3.5.5)

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