Terrestrial photovoltaic (PV) modules - Quality system for PV module manufacturing

IEC 62947:2019 is applicable to organizations manufacturing photovoltaic (PV) modules certified to IEC 61215 series and IEC 62108 for design qualification and type approval and IEC 61730 for safety qualification and type approval. The design qualification and type approval of PV modules depend on appropriate methods for product and process design, as well as appropriate control of materials and processes used to manufacture the product. This document lays out best practices for product design, manufacturing processes, and selection and control of materials used in the manufacture of PV modules that have met the requirements of IEC 61215 series, IEC 61730, or IEC 62108. These standards also form the basis for factory audit criteria of such sites by various certifying and auditory bodies. The object of this document is to provide a framework for the improved confidence in the ongoing consistency of performance and reliability of certified PV modules. The requirements of this document are defined with the assumption that the quality management system of the organization has already fulfilled the requirements of ISO 9001 or equivalent quality management system. This document is not intended to replace or remove any requirements of ISO9001 or equivalent quality management system. By maintaining a manufacturing system in accordance with this document, PV modules are expected to maintain their performance as determined from the test sequences in IEC 61215 series, IEC 62108, or IEC 61730.

Terrestrische Photovoltaik(PV)-Module - Qualitätssystem zur Fertigung von PV-Modulen

Modules photovoltaïques (PV) pour applications terrestres - Système de qualité pour la fabrication des modules photovoltaïques

IEC 62941:2019 que aux organismes fabriquant des modules photovoltaïques (PV) certifiés au titre de la série IEC 61215 et de l'IEC 62108 pour la qualification de la conception et l'homologation et de l'IEC 61730 pour la qualification de la sûreté de fonctionnement et l'homologation. La qualification de la conception et l'homologation des modules PV reposent sur des méthodes appropriées de conception du produit et des processus, ainsi que sur une maîtrise adéquate des matériaux et procédés employés lors de la fabrication du produit. Le présent document établit les meilleures pratiques en ce qui concerne la conception des produits, les processus de fabrication, le choix et la maîtrise des matériaux utilisés dans la fabrication des modules PV satisfaisant aux exigences de la série IEC 61215, de l'IEC 61730 ou de l'IEC 62108. Ces normes constituent également la base des critères pour l'audit d'usine de ces sites par différents organismes de certification et d'audit. Le présent document a pour objectif de fournir un cadre en vue de renforcer la confiance en ce qui concerne la cohérence constante des performances et la fiabilité des modules PV certifiés. Les exigences du présent document sont définies en partant de l'hypothèse que le système de management de la qualité de l'organisme satisfait d'ores et déjà aux exigences de l'ISO 9001 ou d'un système de management de la qualité équivalent. Le présent document n'est pas destiné à remplacer ou à supprimer les exigences de d'ISO 9001 ou d'un système de management de la qualité équivalent. En respectant un système de fabrication conforme au présent document, il est attendu que les modules PV conservent leurs performances telles que déterminées par les séquences d'essais de la série IEC 61215, l'IEC 62108 ou l'IEC 61730.

Prizemni fotonapetostni (PV) moduli - Sistem kakovosti za proizvodnjo PV-modulov

General Information

Status
Published
Publication Date
12-Mar-2020
Current Stage
6060 - Document made available
Due Date
13-Mar-2020
Completion Date
13-Mar-2020

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SLOVENSKI STANDARD
SIST EN IEC 62941:2020
01-maj-2020
Prizemni fotonapetostni (PV) moduli - Sistem kakovosti za proizvodnjo PV-
modulov

Terrestrial photovoltaic (PV) modules - Quality system for PV module manufacturing

Terrestrische Photovoltaik(PV)-Module - Qualitätssystem zur Fertigung von PV-Modulen

Modules photovoltaïques (PV) pour applications terrestres - Système de qualité pour la

fabrication des modules photovoltaïques
Ta slovenski standard je istoveten z: EN IEC 62941:2020
ICS:
03.120.99 Drugi standardi v zvezi s Other standards related to
kakovostjo quality
27.160 Sončna energija Solar energy engineering
SIST EN IEC 62941:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 62941:2020
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SIST EN IEC 62941:2020
EUROPEAN STANDARD EN IEC 62941
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2020
ICS 27.160
English Version
Terrestrial photovoltaic (PV) modules - Quality system for PV
module manufacturing
(IEC 62941:2019)

Modules photovoltaïques (PV) pour applications terrestres - Terrestrische Photovoltaik(PV)-Module - Qualitätssystem

Système de qualité pour la fabrication des modules zur Fertigung von PV-Modulen
photovoltaïques (IEC 62941:2019)
(IEC 62941:2019)

This European Standard was approved by CENELEC on 2020-01-16. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 62941:2020 E
---------------------- Page: 3 ----------------------
SIST EN IEC 62941:2020
EN IEC 62941:2020 (E)
European foreword

The text of document 82/1635/FDIS, future edition 1 of IEC 62941, prepared by IEC/TC 82 "Solar

photovoltaic energy systems" was submitted to the IEC-CENELEC parallel vote and approved by

CENELEC as EN IEC 62941:2020.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2020-10-16

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2023-01-16

document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 62941:2019 was approved by CENELEC as a European

Standard without any modification.
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SIST EN IEC 62941:2020
EN IEC 62941:2020 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60812 - Failure modes and effects analysis (FMEA EN IEC 60812 -
and FMECA)
IEC 60891 - Photovoltaic devices - Procedures for EN 60891 -
temperature and irradiance corrections to
measured I-V characteristics
IEC 60904-1 - Photovoltaic devices - Part 1: EN 60904-1 -
Measurement of photovoltaic current-
voltage characteristics
IEC 60904-2 - Photovoltaic devices - Part 2: EN 60904-2 -
Requirements for photovoltaic reference
devices
IEC 60904-3 - Photovoltaic devices - Part 3: EN IEC 60904-3 -
Measurement principles for terrestrial
photovoltaic (PV) solar devices with
reference spectral irradiance data
IEC 60904-4 - Photovoltaic devices - Part 4: Reference EN IEC 60904-4 -
solar devices - Procedures for establishing
calibration traceability
IEC 60904-7 - Photovoltaic devices - Part 7: Computation EN IEC 60904-7 -
of the spectral mismatch correction for
measurements of photovoltaic devices
IEC 60904-9 - Photovoltaic devices - Part 9: Solar EN 60904-9 -
simulator performance requirements
IEC 61215 - Crystalline silicon terrestrial photovoltaic - -
(PV) modules - Design qualification and
type approval
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SIST EN IEC 62941:2020
EN IEC 62941:2020 (E)
IEC 61730-1 - Photovoltaic (PV) module safety EN IEC 61730-1 -
qualification - Part 1: Requirements for
construction
IEC 61730-2 - Photovoltaic (PV) module safety EN IEC 61730-2 -
qualification - Part 2: Requirements for
testing
IEC 61853-1 - Photovoltaic (PV) module performance - -
testing and energy rating - Part 1:
Irradiance and temperature performance
measurements and power rating
IEC 62108 - Concentrator photovoltaic (CPV) modules EN 62108 -
and assemblies - Design qualification and
type approval
IEC 62759-1 - Photovoltaic (PV) modules - EN 62759-1 -
Transportation testing - Part 1:
Transportation and shipping of module
package units
ISO 9001 - Quality management systems - EN ISO 9001 2015
Requirements
IEC/TS 61836 - Solar photovoltaic energy systems - - -
Terms, definitions and symbols
IEC/TS 62915 - Photovoltaic (PV) modules - Type - -
approval, design and safety qualification -
Retesting
ISO/IEC 2008 Uncertainty of measurement - Part 3: - -
Guide 98-3 Guide to the expression of uncertainty in
measurement (GUM:1995)
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SIST EN IEC 62941:2020
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SIST EN IEC 62941:2020
IEC 62941
Edition 1.0 2019-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Terrestrial photovoltaic (PV) modules – Quality system for PV module
manufacturing
Modules photovoltaïques (PV) pour applications terrestres – Système de qualité
pour la fabrication des modules photovoltaïques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 27.160 ISBN 978-2-8322-7625-9

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 8 ----------------------
SIST EN IEC 62941:2020
– 2 – IEC 62941:2019 © IEC 2019
CONTENTS

FOREWORD ........................................................................................................................... 4

1 Scope .............................................................................................................................. 6

2 Normative references ...................................................................................................... 6

3 Terms, definitions and abbreviated terms ........................................................................ 7

4 Support ......................................................................................................................... 10

4.1 Resources ............................................................................................................ 10

4.1.1 Succession planning ...................................................................................... 10

4.1.2 Provision of resources for product warranty system ....................................... 10

4.2 Monitoring and measuring resources..................................................................... 11

4.2.1 Control of monitoring and measuring equipment ............................................ 11

4.2.2 Control of performance rating (IV) measurement equipment .......................... 11

4.3 Control of documented information........................................................................ 11

5 Operation ...................................................................................................................... 11

5.1 Operational planning and control .......................................................................... 11

5.2 Requirements for products and services ............................................................... 12

5.2.1 Customer communication .............................................................................. 12

5.2.2 Determining the requirements for products and services ................................ 12

5.2.3 Review of the requirements for products and services ................................... 12

5.2.4 Organization manufacturing feasibility ........................................................... 13

5.3 Design and development of products and services ................................................ 13

5.3.1 Design and development planning ................................................................. 13

5.3.2 Design and development inputs ..................................................................... 13

5.3.3 Design and development controls .................................................................. 13

5.3.4 Design and development outputs ................................................................... 14

5.3.5 Design and development changes ................................................................. 14

5.3.6 Manufacturing process design inputs ............................................................. 14

5.3.7 Manufacturing process design outputs ........................................................... 14

5.4 Control of externally provided processes, products and services ........................... 15

5.4.1 General ......................................................................................................... 15

5.4.2 Type and extent of control ............................................................................. 15

5.4.3 Information on external providers ................................................................... 16

5.5 Production and service provision .......................................................................... 16

5.5.1 Control of production and service provision ................................................... 16

5.5.2 Control plan ................................................................................................... 16

5.5.3 Control plan for the measurement procedure ................................................. 17

5.5.4 Control plan for all solar simulators used for performance rating .................... 17

5.5.5 Validation of processes for production and services provisions ...................... 18

5.5.6 Identification and traceability ......................................................................... 18

5.5.7 Customer property ......................................................................................... 18

5.5.8 Preservation of product .................................................................................. 18

5.5.9 Post-delivery activities ................................................................................... 19

5.6 Control of nonconforming outputs ......................................................................... 19

6 Performance evaluation ................................................................................................. 19

6.1 Monitoring, measurement, analysis and evaluation ............................................... 19

6.1.1 Monitoring and measurement of a manufacturing process .............................. 19

6.1.2 Monitoring and measurement of product ........................................................ 20

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SIST EN IEC 62941:2020
IEC 62941:2019 © IEC 2019 – 3 –

6.1.3 Ongoing product monitoring ........................................................................... 20

6.2 Customer satisfaction ........................................................................................... 21

6.3 Analysis and evaluation ........................................................................................ 21

6.4 Internal audit ......................................................................................................... 21

7 Improvement ................................................................................................................. 21

7.1 Corrective and preventive action ........................................................................... 21

7.2 Continual improvement ......................................................................................... 21

Annex A (informative) Correspondence between ISO 9001:2015 and IEC 62941 ................. 22

Bibliography .......................................................................................................................... 25

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SIST EN IEC 62941:2020
– 4 – IEC 62941:2019 © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
TERRESTRIAL PHOTOVOLTAIC (PV) MODULES –
QUALITY SYSTEM FOR PV MODULE MANUFACTURING
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 62941 has been prepared by IEC technical committee 82: Solar

photovoltaic energy systems
The text of this International Standard is based on the following documents:
FDIS Report on voting
82/1635/FDIS 82/1641/RVD

Full information on the voting for the approval of this International Standard can be found in

the report on voting indicated in the above table.
---------------------- Page: 11 ----------------------
SIST EN IEC 62941:2020
IEC 62941:2019 © IEC 2019 – 5 –

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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SIST EN IEC 62941:2020
– 6 – IEC 62941:2019 © IEC 2019
TERRESTRIAL PHOTOVOLTAIC (PV) MODULES –
QUALITY SYSTEM FOR PV MODULE MANUFACTURING
1 Scope

This document is applicable to organizations manufacturing photovoltaic (PV) modules

certified to IEC 61215 series and IEC 62108 for design qualification and type approval and

IEC 61730 for safety qualification and type approval. The design qualification and type

approval of PV modules depend on appropriate methods for product and process design, as

well as appropriate control of materials and processes used to manufacture the product. This

document lays out best practices for product design, manufacturing processes, and selection

and control of materials used in the manufacture of PV modules that have met the

requirements of IEC 61215 series, IEC 61730, or IEC 62108. These standards also form the

basis for factory audit criteria of such sites by various certifying and auditory bodies.

The object of this document is to provide a framework for the improved confidence in the

ongoing consistency of performance and reliability of certified PV modules. The requirements

of this document are defined with the assumption that the quality management system of the

organization has already fulfilled the requirements of ISO 9001 or equivalent quality

management system. This document is not intended to replace or remove any requirements of

ISO9001 or equivalent quality management system. By maintaining a manufacturing system in

accordance with this document, PV modules are expected to maintain their performance as

determined from the test sequences in IEC 61215 series, IEC 62108, or IEC 61730.

This document is applicable to all PV modules independent of design and technology, i.e. flat

panel, concentrator photovoltaic (CPV). Quality controls for CPV and nonconventional flat-

plate manufacturing will differ somewhat from those of more conventional designs; this

document has not considered these differences.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their

content constitutes requirements of this document. For dated references, only the edition

cited applies. For undated references, the latest edition of the referenced document (including

any amendments) applies.
IEC 60812: Failure modes and effects analysis (FMEA and FMECA)

IEC 60891, Photovoltaic devices – Procedure for temperature and irradiance corrections to

measured I-V characteristics

IEC 60904-1, Photovoltaic devices – Part 1: Measurement of photovoltaic current-voltage

characteristics

IEC 60904-2, Photovoltaic devices – Part 2: Requirements for photovoltaic reference devices

IEC 60904-3, Photovoltaic devices – Part 3: Measurement principles for terrestrial

photovoltaic (PV) solar devices with reference spectral irradiance data

IEC 60904-4, Photovoltaic devices – Part 4: Reference solar devices – Procedures for

establishing calibration traceability
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SIST EN IEC 62941:2020
IEC 62941:2019 © IEC 2019 – 7 –

IEC 60904-7, Photovoltaic devices – Part 7: Computation of the spectral mismatch correction

for measurements of photovoltaic devices

IEC 60904-9, Photovoltaic devices – Part 9: Solar simulator performance requirements

IEC 61215 (all parts), Terrestrial photovoltaic (PV) modules – Design qualification and type

approval

IEC 61730-1, Photovoltaic (PV) module safety qualification – Part 1: Requirements for

construction

IEC 61730-2, Photovoltaic (PV) module safety qualification – Part 2: Requirements for testing

IEC TS 61836, Solar photovoltaic energy systems – Terms, definitions and symbols

IEC 61853-1, Photovoltaic (PV) module performance testing and energy rating – Part 1:

Irradiance and temperature performance measurements and power rating

IEC 62108, Concentrator photovoltaic (CPV) modules and assemblies – Design qualification

and type approval

IEC 62759-1, Photovoltaic (PV) modules – Transportation testing – Part 1: Transportation and

shipping of module package units

IEC TS 62915, Photovoltaic (PV) modules – Type approval, design and safety qualification –

Retesting

ISO/IEC Guide 98-3:2008, Uncertainty of measurement – Part 3: Guide to the expression of

uncertainty in measurement
ISO 9001:2015, Quality management systems – Requirements
3 Terms, definitions and abbreviated terms

For the purposes of this document, the terms and definitions given in IEC TS 61836 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following

addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
containment
action taken to protect the customer from the effect of a harmful situation

Note 1 to entry: Containment may include correcting an existing situation or adding additional screening or

retesting.
3.2
control plan

documented description of the systems and processes, and controls required for maintaining

the product and process quality as well as reaction to non-conformance
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SIST EN IEC 62941:2020
– 8 – IEC 62941:2019 © IEC 2019
3.3
customer

end user, investor, installer who purchases modules from the organization for their own use

3.4
design lifetime

design target period during which PV modules are expected to safely satisfy the specified

performance under the specified conditions

Note 1 to entry: Specified conditions include application of use, installation environment configurations and

operation conditions of the PV module in use. The design target period is set considering changes in performance

of PV modules due to aging degradation of parts and materials used in the stated environment.

3.5
Design Failure Mode and Effects Analysis
DFMEA

application of the Failure Mode and Effects Analysis (FMEA) method specifically to design

activities related to the product/service
3.6
Define, Measure, Analyse, Improve, Control
DMAIC

data-driven quality strategy for improving processes and an integral part of a Six Sigma

quality initiative
3.7
Electrostatic discharge
ESD

transfer of electric charge between bodies of different electric potential in proximity or through

direct contact

Note 1 to entry: Electrostatic discharge (ESD) events are known to damage semiconductor devices such as

diodes.
3.8
Failure, Modes and Effects Analysis
FMEA

document that defines the design, process, or solution with requirements and includes

potential modes, causes and severity of effects of failure, along with an evaluation of the

likelihood of their occurrence and ease of detection

Note 1 to entry: FMEA provides a mechanism to prioritize the risks and take appropriate mitigation steps.

3.9
key materials

those materials that affect safety, reliability, product performance, or lifetime of the PV

module

Note 1 to entry: Key materials may include indirect materials. Those materials which are used during the

manufacturing process of PV modules, but are not found in the end product. In most chemical processes,

catalyzers are indirect materials.
3.10
organization

entity that supplies modules to the customer and that has responsibility for design, production,

and after-sales service for the modules or entity that owns the trademark of the PV modules

Note 1 to entry: The organization may subcontract some of its responsibilities for design, production, and the

after-sales service.
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SIST EN IEC 62941:2020
IEC 62941:2019 © IEC 2019 – 9 –
3.11
out of control action plan
OCAP
supporting document to an SPC (Statistical Process Control) chart

Note 1 to entry: An OCAP is typically presented as a flowchart that guides manufacturing floor employees'

reactions to out-of-control situations.

Note 2 to entry: An OCAP consists of activators (which define out-of-control conditions); checkpoints (which are

likely causes for the conditions); and terminators (which contain the action that should resolve the conditions).

Note 3 to entry: OCAPs should be dynamic and updated continually as and when new knowledge and information

become available. A frequently occurring OCAP activator is an indication of a systemic issue in the process.

3.12
Plan, Do, Check, Act
PDCA
four-step process for quality improvement

Note 1 to entry: In the first step (Plan), a way to affect improvement is developed. In the second step (Do), the

plan is carried out, preferably on a small scale. In the third step (Check), a study takes place between what was

predicted and what was observed in the previous step. In the last step (Act), action is taken on the causal system

to affect the desired change.
3.13
Process Failure Modes and Effects Analysis
PFMEA

application of the FMEA method specifically to manufacturing process and activities to the

product/service
3.14
prototype

early sample, model, or release of a product built to test a concept or process, but may not

have been produced with the intended future processes
3.15
Quality Management System
QMS

formalized system that documents the structure, responsibilities, and procedures required to

achieve effective quality management
3.16
quality plan

document, or several documents, that together specify quality standards, practices, resources,

specifications, and the sequence of activities relevant to a particular product, service, project,

or contract
3.17
reliability

ability of an item to perform a required function under given conditions for a given time

interval
3.18
repeatability

closeness of agreement between the results of successive measurements of the same

measurand, carried out under the same conditions of measurement, i.e.:
– by the same measurement procedure,
– by the same observer,
– with the same measuring instruments, used under the same conditions,
– in the same laboratory,
– at relatively short intervals of time
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SIST EN IEC 62941:2020
– 10 – IEC 62941:2019 © IEC 2019

Note 1 to entry: The concept of "measurement procedure" is defined in VIM:2007,2.5.

3.19
reproducibility

closeness of agreement between the results of measurements of the same value of a quantity,

when the individual measurements are made under different conditions of measurement:

– principle of measurement,
– method of measurement,
– observer,
– measuring instruments,
– reference standards,
– laboratory,

– under conditions of use of the instruments, different from those customarily used,

– after intervals of time relatively long compared with the duration of a single measuremen

...

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