ISO 28594:2017 製品受け入れのための受け入れゼロサンプリングシステムとプロセス制御手順の組み合わせ | ページ 6

3.1.1

acceptance

act of an authorized representative of the customer by which the customer, for itself or as agent of another, assumes ownership of existing identified products tendered or approves specific services rendered as partial or complete performance of the contract

3.1.2

average outgoing quality

AOQ

expected average quality level of outgoing product for a given value of incoming product quality

Note 1 to entry: Adapted from ISO 3534-2:2006, definition 4.7.1.

3.1.3

average outgoing quality limit

AOQL

maximum AOQ over all possible values of incoming product quality level for a given acceptance sampling plan and rectification of all non‑accepted lots unless specified otherwise

[SOURCE:ISO 3534‑2:2006, definition 4.7.2]

3.1.4

acceptance quality limit

AQL

quality level that is the worst tolerable average quality of a process, when a continuing series of lots is submitted for acceptance sampling

3.1.5

contract quality requirements

technical requirements in the contract relating to the quality of the product or service and those contract clauses prescribing inspection, and other quality control procedures incumbent on the supplier, to assure that the product or service conforms to the contractual requirements

3.1.6

critical characteristic

characteristic that judgment and experience indicate must be met to avoid hazardous or unsafe conditions for individuals using, maintaining, or depending upon the product; or that judgment and experience indicate must be met to assure performance of the tactical function of a major product or service

3.1.7

critical nonconforming item

item of product that fails to conform to specified requirements for one or more critical characteristics

3.1.8

inspection

conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing or gauging

[SOURCE:ISO 3534‑2:2006, definition 4.1.2]

3.1.9

lower process capability index

index describing process capability in relation to the lower specification limit

>where X_{0,001 35} is the lower 0,001 35‑fractile of the distribution of the quality characteristic.

Note 3 to entry: Adapted from ISO 3534-2:2006, definition 2.7.3.

3.1.10

lower reference interval

Note 1 to entry: For a normal distribution, the lower reference interval − X_{0,001 35} = μ − (μ − 3σ) = 3σ.

Note 2 to entry: Adapted from ISO 3534-2:2006, definition 2.5.8.

3.1.11

major characteristic

characteristic, other than critical, that must be met to avoid failure or material reduction of usability of the item of product for intended purpose

3.1.12

major nonconforming item

item of product that fails to conform to specified requirements for one or more major characteristics, but conforms to all critical characteristics

3.1.13

minimum process capability index

C_pk

smaller of upper process capability index and lower process capability index

Note 1 to entry: Hence C_pk = min. ( ).

Note 2 to entry: Adapted from ISO 3534-2:2006, definition 2.7.5.

3.1.14

minor characteristic

characteristic, other than critical or major, whose departure from its specification requirement is not likely to reduce materially the usability of the item of product for its intended purpose or whose departure from established standards has little bearing on the effective use or operation of the item

3.1.15

minor nonconforming item

item of product that fails to conform to specified requirements of one or more minor characteristics, but conforms to all critical and major characteristics

3.1.16

nonconformity

non‑fulfilment of a requirement

[SOURCE:ISO 9000:2015, definition 3.6.9]

3.1.17

nonconforming item

item with one or more nonconformities

[SOURCE:ISO 3534‑2:2006, definition 1.2.12]

3.1.18

process capability

statistical estimate of the outcome of a characteristic from a process which has been demonstrated to be in a state of statistical control

Note 1 to entry: Adapted from ISO 3534-2:2006, definition 2.7.1.

3.1.19

process capability index

C_p

index describing process capability in relation to specified tolerance

>where X_{0,001 35} and X_{0,998 65} are respectively the lower and upper 0,001 35‑fractiles of the distribution of the quality characteristic.

Note 3 to entry: Adapted from ISO 3534-2:2006, definition 2.7.2.

3.1.20

production interval

period of production under continuous sampling, assumed to exhibit essentially homogeneous quality

Note 1 to entry: A production interval is normally a single shift. It can be a day if it is reasonably certain that shift changes do not affect quality of product, but not longer than a day.

3.1.21

quality

degree to which a set of inherent characteristics fulfils requirements

Note 1 to entry: The term “quality” can be used with adjectives such as poor, good or excellent.

Note 2 to entry: “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic.

[SOURCE:ISO 9000:2015, definition 3.6.2]

3.1.22

quality assurance

part of quality management focused on providing confidence that quality requirements will be fulfilled

[SOURCE:ISO 9000:2015, definition 3.3.6]

3.1.23

quality audit

systematic examination of the acts and decisions with respect to quality in order to independently verify or evaluate the operational requirements of the quality program or the specification or contract requirements of the product or service

3.1.24

quality program

program that is developed, planned, and managed to carry out cost effectively all efforts to effect the quality of materials and services from concept to validation, full‑scale development, production, deployment, and disposal

3.1.25

reference interval

interval bounded by the 0,998 65-fractile, X_{0,998 65}, and the 0,001 35‑fractile, X_{0,001 35}, expressed by the difference X_{0,998 65} − X_{0,001 35}

Note 1 to entry: For a normal distribution, the reference interval X_{0,998 65} − X_{0,001 35} = (μ + 3σ) − (μ − 3σ) = 6σ.

Note 2 to entry: Adapted from ISO 3534-2:2006, definition 2.5.7.

3.1.26

sampling plan

combination of sample size to be used and associated lot acceptability criteria

Note 1 to entry: A sampling plan does not contain the rules on how to draw the sample.

Note 2 to entry: For the purposes of this International Standard, a distinction should be made between the terms sampling plan (3.1.26) , sampling scheme (3.1.27) and sampling system (3.1.28) .

3.1.27

sampling scheme

combination of sampling plans with rules for changing from one plan to another

3.1.28

sampling system

collection of sampling plans, or of sampling schemes, each with its own rules for changing plans, together with sampling procedures including criteria by which appropriate plans or schemes may be chosen

Note 1 to entry: This International Standard contains a set of sampling systems each indexed by verification levels, and either lot size or production interval size ranges.

3.1.29

screening inspection

100 % inspection with rejection of all items or portions found nonconforming

Note 1 to entry: Screening inspection may be concerned only with one particular kind of nonconformity.

[SOURCE:ISO 3534‑2:2006, definition 4.1.7]

3.1.30

traceability

ability to trace the history, application or location of that which is under consideration

Note 2 to entry: In the field of metrology, the definition in ISO/IEC Guide 99 is the accepted definition.

[SOURCE:ISO 9000:2015, definition 3.6.13]

3.1.31

upper process capability index

index describing process capability in relation to the upper specification limit

>where X_{0,998 65} is the upper 0,001 35‑fractile of the distribution of the quality characteristic.

Note 3 to entry: Adapted from ISO 3534-2:2006, definition 2.7.4.

3.1.32

upper reference interval

interval bounded by the 0,998 65‑fractile, X_{0,998 65} and the process median,

Note 1 to entry: For a normal distribution, the upper reference interval X_{0,998 65} − = (μ + 3σ) − μ = 3σ .

Note 2 to entry: Adapted from ISO 3534-2:2006, definition 2.5.9.

3.1.33

verification level

VL

level of importance or utility of a characteristic to the user

Note 1 to entry: The amount of effort to assure conformance can be allocated on the basis of importance to the user. (Major characteristics require more verification effort than minor characteristics.) VL‑7 requires the highest level of effort, and the effort decreases as the VL decreases to the lowest level, VL‑1. Verification levels T and R have been included to allow for tightened inspection for VL‑7 and for reduced inspection for VL‑1.