FprCEN ISO/ASTM/TS 52930

Additive Manufacturing - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-LB equipment (ISO/ASTM/DTS 52930:2021)

This document provides recommended practices for process qualification of metal production parts produced with the powder bed fusion by laser beam process (PBF-LB/M). This document covers only process qualification issues directly related to the AM equipment and does not cover feedstock qualification or post processing beyond powder removal. This guideline addresses IQ, OQ, and PQ issues directly related to the AM machine and connected equipment. Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification.

Additive Fertigung - Grundlagen der Qualifizierung - Installation, Funktion und Leistung (IQ/OQ/PQ) von PBF-LB-Anlagen (ISO/ASTM/DTS 52930:2021)

Dieses Dokument befasst sich mit Fragen der Abnahmebeurteilung (IQ), der Funktionsbeurteilung (OQ) und der Leistungsbeurteilung (PQ), die in direktem Zusammenhang mit dem additiven Fertigungssystem stehen und einen direkten Einfluss auf die Konsolidierung des Materials haben. Die ersten drei Elemente der Prozessvalidierung, Prozessabbildung, Risikobewertung und Validierungsplanung sind notwendige Voraussetzungen für die Maschinenbeurteilung, liegen jedoch außerhalb des Anwendungsbereichs dieses Dokuments.
Dieses Dokument behandelt Themen, die in direktem Zusammenhang mit Anlagen zur additiven Fertigung stehen, und beinhaltet keine andere Rohstoffbewertung oder Nachbearbeitung als die Entfernung von Pulver.
Die physischen Aspekte der Anlage, des Personals, des Prozesses und des Materials werden nur in dem Umfang berücksichtigt, der zur Unterstützung der Bewertung der Maschine erforderlich ist.

Fabrication additive - Principes de qualification - Installation, fonctionnement et performances (IQ/OQ/PQ) de l'équipement de PBF-LB (ISO/ASTM/DTS 52930:2021)

[Not translated]

General Information

• Status: Not Published
• Technical Committee: CEN/TC 438 - Additive Manufacturing
• Drafting Committee: CEN/TC 438 - Additive Manufacturing
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Due Date: 23-Jul-2021
• Completion Date: 23-Jul-2021
• Ref Project: kSIST FprCEN ISO/ASTM/TS 52930:2021 - Additive Manufacturing - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-LB equipment (ISO/ASTM PRF TS 52930:2021)

Standards Content (sample)

SLOVENSKI STANDARD
kSIST FprCEN ISO/ASTM/TS 52930:2021
01-maj-2021
[Not translated]

Additive Manufacturing - Qualification principles - Installation, operation and performance

(IQ/OQ/PQ) of PBF-LB equipment (ISO/ASTM PRF TS 52930:2021)

Additive Fertigung - Grundlagen der Qualifizierung - Installation, Funktion und Leistung

(IQ/OQ/PQ) von PBF-LB-Anlagen ( ISO/ASTM PRF TS 52930:2021)

Fabrication additive - Principes de qualification - Installation, fonctionnement et

performances (IQ/OQ/PQ) de l'équipement de PBF-LB ( ISO/ASTM PRF TS
52930:2021)
Ta slovenski standard je istoveten z: FprCEN ISO/ASTM/TS 52930
ICS:
25.030 3D-tiskanje Additive manufacturing
kSIST FprCEN ISO/ASTM/TS 52930:2021 en,fr,de

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

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kSIST FprCEN ISO/ASTM/TS 52930:2021
TECHNICAL ISO/ASTM TS
SPECIFICATION 52930
First edition
Additive manufacturing —
Qualification principles —
Installation, operation and
performance (IQ/OQ/PQ) of PBF-LB
equipment
Fabrication additive — Principes de qualification — Installation,
fonctionnement et performances (IQ/OQ/PQ) de l'équipement de PBF-
PROOF/ÉPREUVE
Reference number
ISO/ASTM TS 52930:2021(E)
ISO/ASTM International 2021
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kSIST FprCEN ISO/ASTM/TS 52930:2021
ISO/ASTM TS 52930:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/ASTM International 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be

reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on

the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

or ISO’s member body in the country of the requester. In the United States, such requests should be sent to ASTM International.

ISO copyright office ASTM International
CP 401 • Ch. de Blandonnet 8 100 Barr Harbor Drive, PO Box C700
CH-1214 Vernier, Geneva West Conshohocken, PA 19428-2959, USA
Phone: [phone] Phone: [phone]
Fax: [phone]
Email: [e-mail] Email: [e-mail]
Website: www.iso.org Website: www.astm.org
Published in Switzerland
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ISO/ASTM TS 52930:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Abbreviated terms .............................................................................................................................................................................................. 2

5 General concepts .................................................................................................................................................................................................. 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Preliminary considerations .......................................................................................................................................................... 4

6 Elements of process validation .............................................................................................................................................................. 4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Installation qualification (IQ) ..................................................................................................................................................... 5

6.2.1 General...................................................................................................................................................................................... 5

6.2.2 Specific considerations for installation qualification ....................................................................... 5

6.3 Operational qualification (OQ) .................................................................................................................................................. 8

6.3.1 General...................................................................................................................................................................................... 8

6.3.2 Specific considerations for operational qualification ...................................................................... 9

6.4 Performance qualification (PQ) .............................................................................................................................................11

6.4.1 General...................................................................................................................................................................................11

6.4.2 Specific considerations for performance Qualification ...............................................................11

6.4.3 Deterioration of products......................................................................................................................................13

7 Revalidation............................................................................................................................................................................................................13

Annex A (normative) Process capability evaluation (Statistical process control) ............................................15

Bibliography .............................................................................................................................................................................................................................19

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Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

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

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 261, Additive manufacturing, in

cooperation with ASTM Committee F42, Additive Manufacturing Technologies, on the basis of a

partnership agreement between ISO and ASTM International with the aim to create a common set of

ISO/ASTM standards on Additive Manufacturing.
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Introduction

Additive manufacturing is a machine-centric process. This document provides recommended practices

for machine-related process qualification for serial production of metal parts produced with the

powder bed fusion by laser beam process (PBF-LB/M). This document is addressed to organizations

that already have a comprehensive quality system in place.

While this document is process specific, it is intended to apply to any industry with strict quality

requirements. In such industries, it is not possible to complete machine qualification without ensuring

repeatable production of the desired process result, given the current state of AM process knowledge.

Operational quality and part performance quality sections are included for this reason.

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TECHNICAL SPECIFICATION ISO/ASTM TS 52930:2021(E)
Additive manufacturing — Qualification principles —
Installation, operation and performance (IQ/OQ/PQ) of
PBF-LB equipment
1 Scope

This document addresses installation qualification (IQ), operational qualification (OQ), and

performance qualification (PQ) issues directly related to the additive manufacturing system that

has a direct influence on the consolidation of material. The first three elements of process validation,

process mapping, risk assessment, and validation planning, are necessary pre-conditions to machine

qualification, however, they are outside the scope of this document.

This document covers issues directly related to the AM equipment and does not cover feedstock

qualification or post processing beyond powder removal.

Physical facility, personnel, process and material issues are only included to the extent necessary to

support machine qualification.
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.

ISO/ASTM 52900, Additive manufacturing — General principles — Terminology
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/ASTM 52900 and the

following apply.

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

— ISO Online browsing platform: available at https:// www. iso. org/o bp
— IEC Electropedia: available at http:// www.e lectropedia. org/
3.1
installation qualification

establishment by objective evidence that all key aspects of the process equipment and ancillary system

installation adhere to the manufacturer’s approved specification and that the recommendations of the

supplier of the equipment are suitably considered
3.2
operational qualification

establishment by objective evidence process control limits and action levels which result in product

that meets all predetermined requirements
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3.3
performance qualification

establishment by objective evidence that the process, under anticipated conditions, consistently

produces a product which meets all predetermined requirements
3.4
calibration
verification of an instrument’s accuracy against a standard
3.5
verification

confirmation by examination and provision of objective evidence that the specified requirements have

been fulfilled
Note 1 to entry: Verification may include end product testing.
3.6
process validation

establishment by objective evidence that a process consistently produces result of product meeting its

predetermined requirements
3.7
system acceptance test

series of documented procedures and tests agreed between equipment supplier and equipment

purchaser with results meeting predetermined requirements

Note 1 to entry: Satisfactory completion typically constitutes a procurement milestone and can be tied to

payments.
3.8
build interruption
unplanned stop or delay during the build cycle
3.9
means of compliance
method used to satisfy audit requirement
3.10
factory acceptance test
FAT
system acceptance test (3.7) performed at equipment supplier’s facility
3.11
site acceptance test
SAT

system acceptance test (3.7) performed after installation of machine at customer facility

4 Abbreviated terms
The following abbreviated terms are used in this document.
AM additive manufacturing
FAT factory acceptance test
FAI first article inspection
IQ installation qualification
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NDT non-destructive testing
OQ operational qualification
OEM original equipment manufacturer
PQ performance qualification
SAT site acceptance test
SPC statistical process control
5 General concepts
5.1 General

Assurance of product quality is derived from careful attention to many factors including selection of

parts and materials, product and process design, control of the process, equipment installation and

maintenance, and in-process and end-product testing. By managing these factors, a machine user can

establish confidence that all manufactured units from successive manufacturing lots will be acceptable.

The basic principles of quality assurance have as their goal the production of articles that are fit for

their intended use. These principles can be stated as follows:

— quality, safety, and effectiveness shall be designed and built into the end product;

— acceptable quality of the finished product is dependent upon implementing satisfactory quality

controls throughout the manufacturing process and consideration at the inspection and testing

stage only is not sufficient. Testing and inspection proves the quality of the product;

— each step of the manufacturing process shall be controlled to maximize the probability that the

finished products meet all applicable quality and design specifications.

Process validation is a key element in assuring that these quality assurance goals are met. Note: In

some industries, for example aerospace, this element is referred to as special process qualification.

Routine end-product testing alone often is not sufficient to assure product quality for several reasons:

a) some end-product tests have limited sensitivity;

b) destructive testing would be required in some cases to show that the manufacturing process was

adequate;

c) in some situations end-product testing does not reveal all variations that can occur in the product

that can impact on safety and effectiveness.

Successfully validating a process can reduce the dependence upon intensive in-process and finished

product testing. It should be noted that in most cases, end-product testing plays a major role in assuring

that quality assurance goals are met (i.e. validation and end-product testing are not mutually exclusive).

Critical process variables shall be identified, monitored and documented by the machine user. Analysis

of the data collected from monitoring will be used to establish the variability of process parameters for

individual runs to assure that the process is under control. The machine user will then verify whether

the equipment and process controls are adequate to enable product specifications to be met. These

activities are part of statistical process control (see 6.3 Clause 2 and Annex A).

Finished product and in-process test data can be of value in process validation, particularly in situations

where quality attributes and variabilities can be readily measured. Where finished (or in-process)

testing cannot adequately measure certain attributes, process validation should be derived primarily

from qualification of each system used in production and from consideration of the interaction of the

various systems.
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5.2 Preliminary considerations

The machine user should evaluate all factors that affect product quality when designing and

undertaking a process validation study. These factors can vary considerably among different products

and manufacturing technologies and could include, for example, component specifications, air and

water handling systems, environmental controls, equipment functions, powder storage and handling

systems, shielding gas storage and delivery systems, and process control operations. No single approach

to process validation will be appropriate and complete in all cases; however, the following quality

activities should be undertaken in most situations:

a) the product's end use is a determining factor in the development of product (and component)

characteristics and specifications;

b) all pertinent aspects of the product that impact safety and effectiveness should be considered

(including performance, reliability and stability);

c) acceptable ranges or limits should be established for each characteristic to set up allowable

variations in critical process variables;
d) ranges should be expressed in readily measurable terms.

Once a specification is demonstrated as acceptable, it is important that any changes to the specification

be made in accordance with documented change control procedures.
6 Elements of process validation
6.1 General

Validation shall be considered when a new product is introduced, when there is a change in the product,

or when there is a change in the manufacturing process that can affect the product's characteristics.

The following are considered as key elements:
a) process mapping;
b) risk assessment;
c) validation planning – identify processes that need validation;
d) installation qualification;
e) operational qualification;
f) performance qualification.

While the first three elements listed (process mapping, risk assessment, and validation planning) are

key elements of process validation; they are outside the scope of this guideline. When planning for

validation it is important to take in consideration different sizes of product, structure, and volume of

production.

It is essential that the validation programme is documented and that the documentation is properly

maintained. Approval and release of the process for use in routine manufacturing should be based upon

a review of all the validation documentation, including data from the equipment qualification, process

performance qualification, and product testing to ensure compatibility with the process.

For routine production, it is important to adequately record process details (e.g. time, temperature,

equipment used). Documentation requirements should be part of the machine user’s quality system.

Maintenance logs and build logs can be useful in performing failure investigations concerning a

specific manufacturing lot. Process development data (along with specific test data) can also determine

expected variance in product or equipment characteristics.
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6.2 Installation qualification (IQ)
6.2.1 General

Installation qualification studies establish confidence that the process equipment and ancillary systems

are capable of consistently operating within established limits and tolerances. After process equipment

is designed or selected, it should be evaluated and tested to verify that it is capable of operating

satisfactorily within the operating limits required by the process. This phase of validation includes

examination of equipment design, determination of calibration, maintenance, and adjustment of critical

equipment features that could affect the process and product. Information obtained from these studies

should be used to establish written procedures covering equipment calibration, maintenance, set-up,

monitoring, and control.

In assessing the suitability of a given piece of equipment, it is usually insufficient to rely solely upon the

representations of the equipment supplier, or upon experience in producing some other product. Sound

theoretical and practical engineering principles and considerations are a first step in the assessment.

It is important that equipment qualification simulate actual production conditions, including those that

are at extreme limits of the process. These conditions shall be defined and rationalized by the user of

the equipment based on the OEM’s machine specifications.

Tests and challenges should be repeated as necessary to assure reliable and meaningful results. All

acceptance criteria need to be met during the test or challenge. If any test or challenge shows that the

equipment does not perform within its specifications, an evaluation should be performed to identify

the cause of the failure. Corrections should be made, and additional test runs performed as needed, to

verify that the equipment performs within specifications. The observed variability of the equipment

between and within runs can be used as a basis for determining the total number of trials selected for

the subsequent performance qualification studies of the process.
6.2.2 Specific considerations for installation qualification
a) Equipment design validation and installation:

1) system acceptance testing should be completed and documented during the installation.

The equipment supplier should perform a system acceptance test regardless of whether the

equipment purchaser requires one:
i) system acceptance testing can include the following:

aa) factory acceptance testing (FAT) performed at the equipment supplier prior to

delivery:
— equipment purchaser and equipment supplier should agree in advance on FAT

acceptance criteria and data to be collected. Results of the FAT should be documented

and delivered to the machine user;

— if measurements are being taken, verify calibration status for measurement devices;

— as an example of areas that might be included, see ISO/ASTM 52941;
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bb) site acceptance testing (SAT) performed following the installation activity at

the equipment user site by the equipment supplier (equipment user involved or
witnessing);

ii) examine equipment design and locate supplied documentation, prints, drawings, and

manuals, including where applicable, software documentation:

aa) establish a filing location to safely retain the supplied equipment documents;

iii) the user should generate or locate a spare parts list with guidance from the OEM;

2) installation conditions:

i) there should be a documented procedure for humidity, temperature and other environmental

conditions (vibration, etc.) for the machine location:

aa) environmental conditions and limits shall be specified by the OEM. Verification that

the facility is in compliance and able to adequately control and monitor environmental

conditions is the responsibility of the user:

— procedures and equipment used to monitor the environmental conditions should be

recorded in the IQ report.
— humidity and temperature shall each be measured in at least one representative

location in the vicinity of the equipment. Instruments shall be calibrated periodically

and the calibration records maintained. Note that for systems where powder shall be

exposed to atmosphere during loading or other handling operations, direct effects on

the powder shall also be considered in setting appropriate limits.
— consider allowable limits on other environmental factors such as vibration;

bb) The surrounding work area should fulfil the requirements specified by the OEM and have

sufficient space to perform the processing and associated activities. Location of equipment

should allow for adequate servicing, ventilation, and safety;

cc) OEMs are responsible for providing facilities guides detailing siting requirements prior to

system installation. User is responsible for meeting facility requirements prior to install of

the equipment;
ii) verify that all utilities are conforming:

aa) determine machine requirements based on information that shall be provided by OEM. The

OEM should be consulted for specific system facility requirements prior to installation.

Utilities can include:
— electricity;
— inert gas;
— compressed air;
— chill water;
— exhaust;
— electrostatic bonding or grounding;
— computer network or other communications connections, if applicable;
b) procedure control:

1) OEM shall provide adequate instruction and documentation on how to properly operate

equipment;
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2) as part of the installation qualification the user should establish proper documented control

of the AM equipment and supporting equipment. Such written instruction can include the

following and should be documented within the installation qualification:
i) Build preparation and powder bed manufacture- including:
— machine start-up;
— establishment of process conditions;
— build set-up;
— cleaning of build platform;
— build platform removal;
— build monitoring;
— post build (e.g. removal of loose powder and build platform);
— build platform traceability;

ii) powder storage, handling, traceability (labelling conventions) and waste disposal;

iii) configuration management;
iv) nonconforming material in case of build interruption or build anomaly;
v) file preparation;
vi) control of digital workflow;
c) software and data control:
1) data management should be a documented process according to ISO/ASTM 52920 ;

2) software used for file preparation and operation of the AM equipment should be characterized

and (configuration) controlled;

3) the user should have a documented procedure for configuration management to ensure that

software versions are controlled and recorded on manufacturing build records;
4) software updates should be controlled following a written procedure;

5) based on industry and application further software validation can be required;

d) calibration of machines and subsystems:
1) equipment calibration:

i) establish calibration, adjustment, performance tests and expected repair procedures

(including schedules):

aa) calibration schedules of instruments and measurement devices used either within the

process or as part of the calibration of the system shall be determined. Procedures

should be in place to ensure compliance to calibration system. Refer to ISO/IEC 17025

or internal calibration standard;
bb) specific recalibration intervals depend on a number of factors including:
— accuracy requirements set by customers;
— requirements set by contract or regulation;

1) Under preparation. Stage at the time of publication ISO/ASTM/CD 52920:2021.

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— inherent stability of the specific instrument or device;
— environmental factors that can affect the stability;
e) preventive maintenance

1) OEM should provide guidance to frequency, content and tools needed for preventative

maintenance. Procedures should be in place to establish a preventative maintenance

programme. The procedure should ensure that records of maintenance are dul
...