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Virtual and Physical Prototyping

ISSN: (Print) (Online) Journal homepage: www.tandfonline.com/journals/nvpp20

A review on qualification and certification for


metal additive manufacturing

Ze Chen, Changjun Han, Ming Gao, Sastry Yagnanna Kandukuri & Kun Zhou

To cite this article: Ze Chen, Changjun Han, Ming Gao, Sastry Yagnanna Kandukuri & Kun Zhou
(2022) A review on qualification and certification for metal additive manufacturing, Virtual and
Physical Prototyping, 17:2, 382-405, DOI: 10.1080/17452759.2021.2018938

To link to this article: https://doi.org/10.1080/17452759.2021.2018938

© 2021 The Author(s). Published by Informa


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Published online: 29 Dec 2021.

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VIRTUAL AND PHYSICAL PROTOTYPING
2022, VOL. 17, NO. 2, 382–405
https://doi.org/10.1080/17452759.2021.2018938

A review on qualification and certification for metal additive manufacturing


Ze Chena, Changjun Han b
, Ming Gaoa, Sastry Yagnanna Kandukuric and Kun Zhou a

a
Singapore Centre for 3D Printing, School of Mechanical and Aerospace Engineering, Nanyang Technological University, Singapore,
Singapore; bSchool of Mechanical and Automotive Engineering, South China University of Technology, Guangzhou, People’s Republic of
China; cDNV Additive Manufacturing Centre of Excellence, Singapore, Singapore

ABSTRACT ARTICLE HISTORY


Metal additive manufacturing (AM) has tremendous potential for manufacturing geometrically Received 13 October 2021
complex metallic products with freedom of design and desirable performance. Qualification and Accepted 13 December 2021
certification are critical to ensuring the successful adoption of metal AM by various sectors and
KEYWORDS
accelerating the standardisation progress. This article provides a comprehensive review on the Additive manufacturing; 3D
status of standardisation and challenges for the qualification and certification of metal AM, printing; qualification;
which is a timely summary to bridge the readiness gap between metal AM technologies certification; standards
developed at academia and industry. It begins with introducing fundamentals of metal AM
qualification and certification. Thereafter, the status of standards, rules, and regulations
developed by international organisations and communities is summarised and discussed. The
challenges are then addressed, including the qualification and certification process, materials,
process reliability and repeatability, post-processing, data, and standards and protocols. Finally,
the conclusion and future outlook are drawn to provide guidance for future research and
development.

1. Introduction
Qualification and certification are critical steps for
Additive manufacturing or three-dimensional (3D) production realisation and popularisation and appli-
printing is a disruptive technology that can provide cation of products (DebRoy et al. 2018). Qualification
freedom of design and enable fabrication of custo- can be defined as a process of evaluating a prototype
mised or complex products through a layer-by-layer design, a material, and a product during their develop-
fashion (Tian et al. 2017; Han et al. 2020; Li et al. ment or testing. Items to be qualified can be techniques,
2021). It has been widely accepted and adopted in machines, materials, parts, or even suppliers. Certifi-
industrial applications of aerospace, automotive, bio- cation is predominantly established for the satisfaction
medical, energy, space, construction, electronics, and of a certification authority or organisation. Items to be
marine and offshore, etc. (Abdulhameed et al. 2019). certified can be parts, components, systems, or the pro-
According to an industrial insight report on the AM cesses of evaluating a material/product/component
market, the average annual growth of the AM market during or at the end of development/production (DNV
was predicted to be over 20% in the next five years GL 2017a; Bae, Diggs, and Ramachandran 2018). Qualifi-
(Wohler’s Associates 2020). Metal AM, which includes cation and certification can be interchanged in most
directed energy deposition (DED), powder bed fusion cases, as both aim to meet specified requirements.
(PBF), binder jetting, and sheet lamination techniques, However, qualification focuses on whether a product is
plays an increasingly critical role in the AM industrial designed or fabricated according to industrial require-
market due to the superior overall performance of ments, while certification emphasises more on whether
toughness, strength, hardness, and wear and heat deliverables (e.g. products) are satisfied by the authority.
resistance of metallic products as compared to those There are three pillars under the qualification and cer-
of polymeric and ceramic counterparts (Sames et al. tification scheme: standards, rules, and regulations. Stan-
2016; Lee, An, and Chua 2017; Bandyopadhyay, dards are to satisfy various requirements from industrial,
Zhang, and Bose 2020). trade, and consumer groups globally (Monzón et al.

CONTACT Changjun Han cjhan@scut.edu.cn School of Mechanical and Automotive Engineering, South China University of Technology, Guangzhou
510641, People’s Republic of China; Kun Zhou kzhou@ntu.edu.sg Singapore Centre for 3D Printing, School of Mechanical and Aerospace Engineering,
Nanyang Technological University, 50 Nanyang Avenue, Singapore 639798, Singapore
© 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-
nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built
upon in any way.
VIRTUAL AND PHYSICAL PROTOTYPING 383

2015). Typical organisations, which are working on metal been working on promoting specific standards and
AM standards covering materials, processes, post-pro- rules and regulations for metal AM.
cesses, and inspections, include the ASTM International, An overview of the qualification and certification for
International Organization for Standardization (ISO), metal AM is illustrated in Figure 1. The qualification
Society of Automotive Engineers (SAE), Aerospace process is to demonstrate the ability to fulfil specified
Materials Society (AMS), American Society of Mechanical metal AM requirements that may involve specification
Engineers (ASME), and American Welding Society (AWS) review, design verification, feed stock, materials, manu-
(Seifi et al. 2017; Lee, Nagalingam, and Yeo 2021). The facturing process follow-up, product testing and
developments of AM standards provide industrial guide- inspection, and document preparation and review
lines for mutual understanding, clear communication, etc. The certification process is to assure the compli-
accurate measurement, easy commerce, and robust ance with qualified parameters, standards, or specific
manufacturing. requirements that may involve unscheduled survey
Rules can be described as guidelines or industry prac- of the metal AM process, testing and inspection,
tice, while regulations refer to the directives or statutes verification of traceability, witnessing of test speci-
enforced by the law. Both are guided by international mens, verification of compliance to requirements, and
organisation standards and developed to fulfil regulat- documentation of compliance in the form of a
ory, technical, and safety requirements in certain certificate.
sectors. For example, aviation authorities like the The feasibility of metal AM technology for target pro-
Federal Aviation Administration (FAA) and European ducts should be primarily evaluated and qualified. Metal
Aviation Safety Agency (EASA) developed their rules AM opportunities may come from existing and new pro-
and regulations for metal AM parts in the aerospace ducts, which will determine the selection of materials (e.g.
sector (Singamneni et al. 2019). Because of the specificity powders, wires, and sheets) and processes (e.g. PBF, DED,
and complexity of aerospace products, their qualifica- binder jetting, and sheet lamination). The feasibility of the
tion and certification protocols may not be applicable existing products focuses on the direct printing for both
to other industries. Therefore, some commercial organis- small batch production and bypassing for long supply
ations, including the Det Norske Veritas (DNV), Bureau chain/lead time, the structure optimisation on lightweight
Veritas (BV), Lloyd’s Register (LR), American Bureau of and non-assembly through redesign, and repair and rema-
Shipping (ABS), Underwriters Laboratories (UL), and nufacture. The design of the new products should be con-
Technischer Überwachungsverein (TÜV SÜD) have sidered to achieve multiscale, multifunctional, and

Figure 1. Overview of qualification and certification for metal AM.


384 Z. CHEN ET AL.

hierarchical structures with remarkable and desired insightful works in this field is of great importance to
properties. introduce and broadcast knowledge about qualification
Technical specifications (e.g. topological optimis- and certification, which will bridge the readiness gap of
ation, part consolidation, part integration, ease to metal AM technologies between academia institutes
repair, and material usage and recycle) can be estab- and industry.
lished by considering the technology capabilities and This article aims to provide a comprehensive review
productivities, while product design specifications can on the status of standardisation and challenges for the
be established according to product application require- qualification and certification of metal AM, and thus
ments (e.g. hardness, toughness, strength, fatigue, cor- propose frameworks as the qualification and certifi-
rosion resistance, and wear resistance). The cation pathway for a broad range of industries. After a
characterisation and review of the materials should be brief introduction in Section 1, Section 2 summarises
utilised for quality control. The operation procedure the status of standards and the developments in rules
and process parameters should be assessed according and regulations related to metal AM in representative
to the technical requirements and product manufactur- international organisations and discusses the gaps and
ing procedure specification. Then, sample testing for their approaches to fulfil qualification and certification.
consistency and robust production performance vali- Projects and application cases, which have been
dation can be witnessed or proven for serial production qualified and certified by industries, are presented to
qualification during metal AM processes and post-pro- assess the benefits from standards, rules, and regu-
cessing. Metal AM certification is a repetitive exercise lations. In Section 3, qualification and certification frame-
to certify the conformity of a single product or series works and cost-effective pathways are proposed to
of product batches. The type of certification often accelerate the adoption of metal AM and manage
depends on the criticality of the component, which in quality risk. Finally, Section 4 concludes with an
turn defines the involvement of certification require- outlook on the challenges and opportunities in the
ments/activities, and thus building and bringing trust development of a robust qualification and certification
to the product. process for metal AM.
There are gaps in qualification and certification for
metal AM, such as standards that can support qualifying
and certifying various systems (Junghans et al. 2020). 2. Qualification and certification
Compared to conventional manufacturing processes, development
the unified acceptance criteria for detecting metal AM
2.1. Standards development
defects (e.g. non-destructive testing for cracks and por-
osity) have not been established yet. Particularly, the ISO and ASTM are the leading developers of voluntary
metallurgical process complexities of metal AM make it international standards in the world and have been
difficult to establish standards in a systematic and uni- playing critical roles in the development of AM stan-
versal form (Frazier 2014). The American National Stan- dards. The two organisations established AM Commit-
dards Institute (ANSI) and Additive Manufacturing tees ASTM F42 and ISO/TC 261 in 2009 and 2011,
Standardization Collaborative (AMSC) have been trying respectively (ANSI 2011; Monzón et al. 2015). In 2011,
to address the qualification and certification gaps of ISO and ASTM signed a cooperative agreement titled
metal AM (Russell et al. 2019). Partner Standards Developing Organization (PSDO) to
Currently, there are limited research works on the eliminate the duplication of standards and maximise
qualification and certification of metal AM parts, and resource allocation within the AM field (ASTM Inter-
most AM standards are still under development. national 2011). There are 28 active Joint Groups consist-
Several books briefly introduced the qualification of ing of experts nominated by the ISO/TC 261 and ASTM
metal AM from different aspects such as technical and F42 committees to develop international standards for
scientific challenges, materials, and processes (Chua, the AM field globally (Moroni, Petrò, and Shao 2020;
Wong, and Yeong 2017; Bae, Diggs, and Ramachandran ISO 2021). Prioritised topics on the development of AM
2018; Dutta, Babu, and Jared 2019a). Mohsen et al. sys- standards by ISO/ASTM include the characterisation of
tematically reviewed the qualification and certification AM materials, test methods of mechanical properties
of AM parts in the aerospace industry since 2016 (Seifi of AM parts, qualification principles, design guidelines,
et al. 2016; Russell et al. 2019; Singamneni et al. 2019). feedstock recycling/reuse guidelines, round-robin
In view of the rapid development of metal AM in testing protocols, standard test artifacts, AM parts pro-
various industries and the increasingly significant role curement requirements, existing terminology standards
of standardisation in AM, a timely summary of the harmonisation, etc.
VIRTUAL AND PHYSICAL PROTOTYPING 385

ISO/TC 261 and ASTM F42 have co-established a Table 1. Summary of published ISO/ASTM AM standards related
common structure that addresses their perspectives to metal AM (ASTM International 2020; ISO 2020).
and requirements for AM standards. The structure Published active ISO/AM standards
defines three levels of AM standards, Including the Simplified title with reflecting on
Topic Code standard scope
general, category, and specialised standards. The
Terminology ISO/ASTM General principles – Terminology
general standards specify basic concepts and general 52900:2015
requirements (terminology, data formats, qualification ISO/ASTM Coordinate systems and test
52921:2013 methodologies
guidance, system performance and reliability, design General principle ISO 17296- General principles – Part 2: Overview
guides, test methods, test artifacts, safety, inspection 2:2015 of process categories and feedstock
ISO 17296- General principles – Part 3: Main
methods, etc.), which are applicable to commonly used 3:2014 characteristics and corresponding
AM materials and processes and potential applications; test methods
ISO/ASTM General principles – Part 4: Overview
the category standards indicate requirements for a 52950:2021 of data processing
certain material type (e.g. powders, sheets, and wires) ISO/ASTM General principles – Requirements for
or a process category (e.g. PBF, DED, and binder 52901:2017 purchased AM parts
Materials and F2924-14 Ti6Al4V with PBF
jetting); the specialised standards refer to requirements processes F3001-14 Ti6Al4V ELI (Extra Low Interstitial)
for a particular material, process, or application (e.g. with PBF
F3049-14 Guide for characterising properties of
material-specific size/chemical specifications, process- metal powders used for AM
specific performance test methods, and industrial processes
F3055-14a Nickel alloy (UNS N07718) with PBF
sector specifications) (Naden 2016). F3056-14 Nickel alloy (UNS N06625) with PBF
Summaries of 28 published standards and 60 pro- F3184-16 Stainless steel alloy (UNS S31603)
with PBF
posed in-development standards related to metal AM F3187-16 Guide for DED of metals
by ISO/ASTM are listed in Tables 1 and A1, respectively F3213-17 Standard specification for Co28Cr6Mo
(ASTM International 2020). The standards of terminology via PBF
F3301-18a Standard specification for thermal
define and regulate AM terms to eliminate confusing post-processing metal parts made
jargon and allow for efficient and accurate communi- via PBF
F3302-18 Standard specification for titanium
cation globally within the AM ecosystem. The standards alloys via PBF
for general principles mainly cover all the fundamentals F3318-18 Specification for AlSi10Mg with PBF-
LB
of AM and define the minimum acceptance criteria for ISO/ASTM Installation/Operation and
materials and parts. They also guide the perspectives 52930:2021 performance qualification (IQ/OQ/
PQ) of Laser-Beam PBF equipment
of process categories and feedstock, main characteristics for production manufacturing
and test methods, data processing, and procurement. ISO/ Practice for metal PBF process to
Standardisation of materials and process is the priority ASTM52904- meet critical applications
19
to be established in the metal AM field, as indicated by 14 ISO/ASTM Methods to characterise metal
published and 9 proposed standards (Tables 1 and A1). In 52907:2020 powders
Design F3413-19 Guide for design – DED
particular, 11 published and 6 proposed standards are ISO/ Design – Requirements, guidelines
applicable to the PBF process; 1 published and 2 pro- ASTM52910- and recommendations
18
posed standards are applicable for the DED process. ISO/ Design – Part 1: Laser-based PBF of
Regarding AM materials, nickel and titanium alloys are ASTM52911- metals
1-19
the priority in standards development. Test methods F2971-13 Standard practice for reporting data
Standards for design contribute to determining the for test specimens prepared by AM
utilisation of design considerations in a project of F3122-14 Guide for evaluating mechanical
properties of metal AM materials
various metal AM processes. The design freedom of ISO/ASTM Test artifacts – Geometric capability
metal AM is subjected to the understanding of the limit- 52902-19 assessment of AM systems
Qualification ISO/ASTM Qualifying machine operators of laser
ations of materials and processes engaged. The stan- principle 52942:2020 metal PBF machines and
dards of design contain general principles and equipment used in aerospace
applications
recommendations of design, guidance for a specific Data ISO/ASTM Specification for AM file format (AMF)
printing process, AM file support for modeling, and 52915:2020 version 1.2
post-processing. These standards aim to provide gui-
dance for metal AM parts in the design of devices, com-
ponents, systems, products, etc.
Test methods are of great importance in the stan- assess the required incoming and unique deliverable
dards development of ISO/ASTM with 20 standards pub- features (e.g. feedstock powder/wire characterisation,
lished and under development for metal AM. They printed specimen location and orientation, test artifacts
386 Z. CHEN ET AL.

of geometric capability, non-destructive testing, and a non-destructive testing standard, which aims to
evaluation of post-processing). Test method standards address the common causes and nature of defects
define the minimum requirements specified in the during the DED process and the applicability of tra-
general principles and build the foundation of inspec- ditional test methods for DED; a wire arc additive manu-
tion for qualification, which are used to validate the per- facturing (WAAM) standard that covers terminology,
formance of AM products for assuring their quality opportunities and restrictions of materials, geometry
reliability and consistency. constraints, inspection, and finishing requirements.
There are a limited number of published standards on Some international and national/regional institutes
the topics of qualification principle and data, as shown in also devote themselves to the development of the stan-
Table 1. The first qualification principle standard (ISO/ dards for metal AM. In 2013, the Association of German
ASTM 52942:2020) regarding laser PBF machine oper- Engineers, also known as Verein Deutscher Ingenieure
ators for aerospace applications was published in 2020, (VDI) introduced one of the first standards for metal
which opens the door to a healthy and robust ecosystem AM, VDI 3405-2, with the scope of qualification, quality
of metal AM by the fulfilment of necessary industrial assurance, and post-processing of laser beam melting
requirements and evaluations. A total of seven qualifica- parts. Standards developed by VDI include some printa-
tion-related standards are proposed and under develop- ble material datasheets (e.g. AlSi10Mg, Ti6Al4V, Inconel
ment, as depicted in Table A1, which cover the fields of 718), printing processes, design recommendations, etc.
industrial AM sites and machine operators for specific The German Institute for Standardization (DIN) is
processes and applications. actively promoting metal AM standardisation. There
The data-driven approach is promising for the metal are two joint working committees that have been devel-
AM industrialisation due to digital 3D files and other oping metal AM standards under the DIN standards AM
input data such as the control programme for printing. section (NA 145-04 FB), i.e. interdisciplinary topics and
Meanwhile, various measurements and sensing equip- digitalisation (NA 145-04-01 AA) and joint working com-
ment that are used for machines generate output data mittee for metals (NA 145-04-02 GA). Being the German
as a record for quality control and further optimisation mirror committee to the European Technical Commit-
feedback. The standardisation of the metal AM data eco- tees CEN/TC 438 and ISO/TC 261, NA 145-04-01 AA
system has attracted attention from industries. For deals with terminology, testing, and related information
example, ISO/ASTM 52915 defines a specification for the technology (e.g. data formats, digital data interfaces,
AM file format, which provides guidance on the prep- software architectures, and domain-specific digital tech-
aration, display, and transmission of files. Moreover, nologies requirements) in metal AM (DIN 2021). NA 145-
other aspects of AM data, such as data formats, data regis- 04-02 GA is the German mirror committee to the inter-
tration, data pedigree, and data processing, are regulated national working group ISO/TC 261/JWG 5, which
under six proposed standards listed in Table A1, by which focuses on the application of PBF, DED, and sheet lami-
various huge volume data can be collected via a common nation (DIN 2021). DIN has published DIN SPEC 17071
method. The proposed standards related to data topics which defines the requirements for AM manufacturing
also provide guidance to process and organise different centres (DIN 2019).
AM data types, which enable their identification and The Society of Automotive Engineers (SAE) Aerospace
usage in downstream applications, including qualifica- Materials Specification Additive Manufacturing (AMS-
tion, certification, and analytics. AM), a technical committee in SAE’s aerospace materials
There is an increasing number of government insti- system group, aims to develop and maintain aerospace
tutes and commercial companies in collaboration with specifications and AM technical reports. The AM reports
ASTM and ISO for the development of metal AM stan- include the precursor materials, printing processes, sys-
dards. For example, ASTM and the British Standards Insti- tematic demands, pre- and post-processing, quality
tution (BSI) collaborated to develop standards for DED assurance, and non-destructive testing. The specifica-
with the support from Innovate UK. Private companies tions for metal precursor materials and printed com-
including Airbus, General Electric, Guest, Keen and Net- ponents as well as processes with sufficient controls
tlefolds, British Aerospace Systems, and Rolls-Royce and traceability for safety-critical parts are under devel-
have been participating in this collaboration to acceler- opment (SAE International 2018). Figure 2 lists the stan-
ate the development of the standards (Rapid News Pub- dards published and under development by SAE AMS-
lications 2019). The three standards include a AM, and materials and processes are the priority in
specification for using wires as the feedstock for addres- their standardisation. Materials such as titanium alloy,
sing the key requirements of material chemistry, toler- nickel alloy, and precipitation-hardening steel are tar-
ance, contamination, packaging, handling, and storage; geted for standardisation; laser PBF, electron beam
VIRTUAL AND PHYSICAL PROTOTYPING 387

Figure 2. Standards published and under development by SAE AMS-AM (SAE International 2021).

PBF, laser wire DED, plasma arc DED, and post-proces- A subsequent specification, MSFC-SPEC-3717 pro-
sing are the focused processes of the committee. With vides a consistent framework for evaluating AM parts
emphasis on consistency and reliability, SAE AMS has during their development and production for spacefl-
established a comprehensive database on materials ight applications (Williams and Butler-Jones 2019). It
and processes for conventional manufacturing, which contains requirements addressing material property
provides a solid foundation to develop metal AM stan- development, part classification, part process control,
dards by SAE AMS-AM. part inspection and acceptance, qualification of laser
A centre-level standard (MSFC-STD-3716) was pub- PBF metallurgical processes, equipment process
lished by the National Aeronautics and Space Adminis- control, and personnel training. The two MSFC standards
tration (NASA) Marshall Space Flight Center in 2017, allow for witness testing schemes based on individual
which aims to establish the laser PBF process standard part acceptance and can be used as an ongoing statisti-
practices. It has been used as the foundation of the cal process control methodology for continuous oper-
implementation of printing processes for AM parts in ation paradigm for NASA hardware producers.
human spaceflight programmes. Based upon the stan- NASA recently published another Technical Standard,
dard, an agency-level standard has been proposed for NASA-STD-6030, which defines the minimum require-
other AM processes and is readily adaptable to all ments for AM processes used in the design, fabrication,
NASA programmes. Figure 3 exhibits the topical and testing of spaceflight hardware for NASA (NASA
outline of general AM quality control requirements for 2021). This standard is applicable to both metals and
MSFC-STD-3716 (NASA 2017). It shows the general tech- polymers, and metal AM technologies covered include
nical requirements, such as an AM control plan to govern L-PBF and DED.
engineering and production practices from establishing The standards developed via the American Society of
foundational processes to placing parts into service. Mechanical Engineers (ASME) focus on AM design,
These practices together with an active quality pro- including ASME Y14.46 and ASME Y14.47 (ASME 2017).
cedure provide quality assurance. The control require- The former standard ASME Y14.46, Product Definition
ments of the foundational process for laser PBF for Additive Manufacturing, covers the features unique
provide the benchmark for realising part design and pro- to AM technologies and term definitions and rec-
duction reliability, including the qualification of pro- ommends the unitive specifications for the definition
cesses, equipment controls, personnel competency, data sets of products, which involves subjects including
and material properties. The control requirements for design, manufacturing, and quality engineering; the
part production, which are representative in aerospace latter standard ASME Y14.47 establishes a schema for
industry operations, include controls for design and regulating 3D models and other associated information
assessment, part production plan, first article processes, within the context of digital product definition data sets
and production controls. for the purpose of conveying a product definition, which
388 Z. CHEN ET AL.

Figure 3. Topical outline for MSFC-STD-3716 (NASA 2017).

is the foundation of design development in a model- AM qualification process and to create a framework for
based enterprise. Additionally, ASME Y14.47 outlines the acceptance criteria for metallic materials in the oil
model organisation schema practices to support and gas industry (API 2021). The standardisation from
model-based definitions and provides guidelines for the API 20S task group was initiated by 90 members
computer-aided design users. The schema is compliant from 51 organisations in various countries in the field
with an annotated model, which is defined in another of AM, including end-users, original equipment manufac-
standard, Digital Product Definition Data Practices turers, AM machine manufacturers, AM feedstock manu-
(ASME Y14.41). facturers, and academic institutions. Along the lines of
The American Welding Society (AWS) initiated the the well-established and widely used product specifica-
D20 committee for the development of metal AM stan- tion levels in the oil and gas industry, a novel tiered
dards. Based on supply chain sectors, several task approach was formulated using the Additive Manufactur-
groups were set under the committee, i.e. D20A/TG1, ing Specification Levels (AMSL) to facilitate the matching
D20B/TG2, D20C/TG3, D20E/TG5, and D20F/TG6 with of the appropriate qualification rigour to the required
the scope of general requirements, material character- level of application criticality. The tiered approach
istics, pre-qualification, fabrication, and inspection, covers AM process qualification, as-printed product qua-
respectively. A published standard (AWS D20.1) has lification, and product supplemental requirements. The
already been used as an AM vendor qualification tool AMSL spans from Level 1 (least critical) to Level 3 (most
by industries (AWS 2020). It provides the general require- critical) to signify the increasing level of product techni-
ments for the fabrication of metal components using cal, quality, and qualification requirements. In addition,
AM, which include the design, qualification, fabrication, the API 20S task group has been actively working
inspection, and acceptance of AM components. towards the alignment with multiple AM standards and
The American Petroleum Institute (API) 20S Standard specifications from ABS, DNV, ISO, ASTM, ASME, ANSI,
has been designed to streamline and standardise the etc. (De Bernardi and Miller 2020).
VIRTUAL AND PHYSICAL PROTOTYPING 389

Table 2. Testing items in the order of importance levels of AM quality consistency including raw materials, machine,
parts from GB/T 35022 (SAC, 2019). ‘+’, ‘0’, and ‘-’ mean operator, and parts (SSC 2020). Another Technical Refer-
compulsory testing, recommended testing, and unnecessary ence TR 92: 2021 released recently with the focus on
testing, respectively.
design guidelines for AM parts, with PBF for metal
Importance level
parts as the predominant process while including DED
Testing item High Middle Low
for comprehensiveness. TR 92 emphasis risk mitigation
Surface characteristics Appearance 0 0 0
Surface Roughness + 0 0 during design and pre-design stage for parts requires
Geometric Length & Angular + + + safety and reliability considerations (SSC 2021).
characteristics Tolerance
Geometric Tolerance + + + Other organisations are also actively involved in the
Mechanical Properties Hardness + + + development of metal AM standards for commercial
Tension + + +
Impact + + 0 and industrial purposes. For example, the National Addi-
Compression + + 0 tive Manufacturing Innovation Cluster Singapore
Bending + 0 0
Fatigue + 0 -
(NAMIC) supports standardisation activities of the
Creep + 0 - ASTM International through R&D activities to facilitate
Friction + 0 - the commercialisation of AM technologies in frontier
Shear + 0 0
Others Density + + + sectors such as aerospace, maritime and offshore, and
Physicochemical + 0 - logistics and fabrication. NAMIC joined the ASTM Inter-
national’s Global AM Center of Excellence as the first
strategic partner in Asia to address technical and scien-
The National Standardization Administration of China tific needs of qualification (NAMIC.sg 2018). In the elec-
(SAC) Technical Committee has been leading the devel- trical and electronics industry, a few international
opment of national AM standard construction guidelines associations have started to work on the standards and
since 2018. The first national AM standard released in guidelines of electronics made through AM. The Institute
China, GB/T 35022-2018, gives the guidance for test of Electrical and Electronics Engineers (IEEE) developed
items, test methods, test reports, etc. This national stan- standards for data management, simulation, and test
dard applies to the testing of metal, plastic, and ceramic methods of printed electronics (America Makes and
parts prepared by AM processes as well as powder ANSI AMSC 2018). The Institute of Printed Circuits
materials. Metal AM parts are recommended to be (IPC)–Association Connecting Electronics Industries®
tested according to the importance levels of parts as pre- and the Japan Electronics Packaging and Circuits Associ-
sented in Table 2. High, middle, and low importance ation (JPCA) have collaborated to establish guidelines
levels indicate critical parts with safety priority consider- and standards for the design, material, and test
ation, functional parts without safety priority consider- method of AM electronics (Tan, Chua, and Tran 2016).
ation, and design evaluation prototype parts,
respectively. Parts at the high importance level will be
2.2. Rules and regulations development
tested for surface and geometric characteristics as well
as overall properties to minimise the risk of part usage, Qualification and certification organisations are essential
while parts at the low importance level will be tested in accelerating the commercialisation of metal AM tech-
with specific properties such as tolerance, hardness, niques into industries by providing various types of ser-
tension, and density, according to the effective cost for vices, such as feasibility evaluation, training and
design evaluation and prototypes (SAC 2019). consultancy, quality management system accreditation,
Singapore Standard Council (SSC) Manufacturing testing and audit, and survey. The organisations can
Standards Committee has been leading the develop- safeguard the reliability of the industrial application of
ment of AM guidelines and standards since 2019. The metal AM through releasing rules and regulations to
first Technical Reference TR 70: 2019 was published to qualify or certify materials, structural design, equipment,
provide guidelines for metal product process selection processes, and products. The class programmes, class
between conventional manufacturing and AM, which guidelines, advisory notes, and guidance notes, which
helps the industry to determine the suitability and are typically involved in rules and regulations, are devel-
justify the benefits and limitations of engaging AM for oped and published for elaborating standards to specific
new or redesigned manufacturing process (SSC 2019). industries. Type approval, certificate of conformity, and
The standard SS 666: 2020 for qualification of parts approval of manufacturer are used to describe
printed by metal AM was published to provide a frame- different types of accreditation for qualification and cer-
work with part classification and qualification require- tification under the class scheme, which originated from
ments for metal AM processed part with the aim of marine insurers classifying the conditions of ships (IACS
390 Z. CHEN ET AL.

2011). The type approval or certificate of conformity is feedstock in the form of powder or wire, including
issued to a product that can meet regulatory, technical, steel-based materials (e.g. high-strength steel, austenitic
and safety requirements. The approval of manufacturer stainless steel, and duplex steel), aluminium, copper,
confirms that the service providers/suppliers are in com- nickel, and titanium alloys (DNV GL 2019).
pliance with the international standards, regulations, or The class guideline (DNVGL-CG-0197) offers a frame-
recognised rules for proof of high quality and safety work for the approval and certification of materials, com-
standards. ponents, and products and is relevant to AM materials
Being one of the biggest classification and certifi- suppliers and service providers as well as end-users
cation societies for AM products approval, DNV is adopting AM in the maritime industry.
actively providing different services related to the assur- The specific standard (DNVGL-ST-B203) presents an
ance of AM based on their extensive involvement in internationally acceptable quality management frame-
energy, marine and offshore, and other allied industries work for the quality consistency of AM parts for the oil
globally. DNV has conducted feasibility and pilot studies and gas industry. Furthermore, this standard can be
on metal AM products and established several rules and employed as a guide to establish quality procedures,
regulations, which include two class programmes, one identify essential parameters, and specify requirements
class guideline, and one specific standard. and guidance on the qualification of metal AM products.
The first class programme (DNVGL-CP-0267) includes Figure 4 illustrates the certification pathway devel-
the requirements of approval requests, documentation, oped under the rules and regulations of DNV for AM pro-
approval scope and limitations, approval testing, ducts in the energy as well as marine and offshore
quality control, and process verification. This programme industries (DNV GL 2017a). The qualification or certifi-
is applicable for the manufacturers and sub-suppliers of cation requests may come from AM service providers,
AM materials and products (DNV GL 2017a). The product owners, or end-users. The request evaluation
second class programme (DNVGL-CP-0291) specifies the always starts from the design review of a 3D model
requirements that the manufacturers should comply with the approval of design or type approval as the
with to obtain certificates for the manufacture of first deliverable. In most cases, technology assessment

Figure 4. DNV AM certification process flow (DNV GL 2017a).


VIRTUAL AND PHYSICAL PROTOTYPING 391

is necessary for AM stakeholders for market access to services related to the qualification of AM manufacturers,
identify the potential failure modes. Then, a parallel service providers, and AM parts specified in DNVGL-ST-
activity for the qualification of feedstock can be carried B203 (DNV GL 2021).
out to obtain the type approval of feedstock certificate. BV offers a voluntary certification scheme to address
AM manufacturers should go through initial qualification the challenges of quality, safety, and environmental per-
before production, which includes build process qualifi- formance in the AM field. An AM rule published by BV
cation, printing and post-processing, and evaluation (NI662 DT R00 E 2019) describes a certification scheme
and testing. The approval of AM manufacture compli- of WAAM products, including scope, activities, and deli-
ance certificate can be obtained based on the assess- verables for the usage of ships and offshore units
ment of AM workshop during the initial qualification. (Figure 5) (BV 2019). The scope involves the raw material
For AM with sufficient production readiness, the assess- suppliers and manufacturers of AM. The certification of
ment of AM components or parts should be carried out the raw material supplier applies to the type approval
by testing of the material and product properties, such and periodical control tests of wires used in WAAM for
as the functionality test or pressure test. Certificate with high-strength steel, austenitic and austenitic-ferritic
the approval of manufacturer and 3.2 certificate (state- stainless steel, martensitic stainless steel, and aluminium
ment of compliance issued by inspector designated by bronze. The type approval certificate can be issued when
the official regulations under European standard EN the raw material supplier completes the approval tests
10204) for non-class could be obtained based on 3.1 cer- satisfactorily. The certificate of recognition can be
tificate (statement of compliance issued by authorised achieved by review and audit on an organisation’s man-
inspection representative by the manufacturer under agement structure, quality system, quality manual, and
European standard EN 10204) and function testing. documented procedures (BV 2018).
There is a systematic pathway for the approval and Under NI662 DT R00 E, the documents of product
certification of AM-related processes and products in design, such as design drawings, material technical spe-
DNV. The latest published service specification (DNVGL- cification, part technical specification, and calculation
SE-0568) describes the qualification management notes, should be submitted for design review. Process

Figure 5. BV certification scheme for products made by WAAM (BV 2018).


392 Z. CHEN ET AL.

approval certification starts with a preliminary AM pro- certification of materials and parts. AM processes
cedure specification prepared by a manufacturer, covered by the guidance notes are electron beam PBF,
which should be submitted to BV for review and wit- laser PBF, laser DED, and WAAM. The guidance notes
nessed by the surveyor prior to testing. Thereafter, the provide a modular approach for the certification of metal
preliminary AM procedure specification is approved as AM segments (e.g. design, material supply, printing
a final specification of all the parameters that character- process, post-processing, and inspection), which can facili-
ise the WAAM process. The certification of products tate the qualification of each segment. Thereafter, parts are
should be carried out individually or per batch according released with an affirmative certificate (LR and TWI 2020).
to the product category pre-defined at the design stage. TÜV SÜD is a German testing and certification organ-
For products tested with satisfactory results, a certificate isation. TÜV SÜD certification framework provides three
will be issued with the endorsement from surveyors. types of AM certification, i.e. production workflow certifi-
ABS has developed guidance notes for the AM qualifi- cation, production facility certification, and product
cation process, which can be categorised into the stages approval and certification. The production workflow cer-
of feasibility, verification, pre-production validation, and tification contains design, manufacturing process, and
production (ABS 2018). At each stage, ABS reviews a pro- regulatory conformity to ensure the manufacturability
posed cradle-to-grave file, which is the data package and reliability of AM products are within defined specifi-
specifying the entire design, production, inspection, cations. The production facility certification aims to
and testing information for an AM part. The aim of the evaluate and certify industrial production sites that
feasibility stage is to assess if AM processes can theoreti- provide AM services. The product approval and certifi-
cally produce a part that can meet the design require- cation ensure the AM processes and products to
ments. Therefore, the feasibility evaluation focuses on conform with the industrial standards, rules, and techni-
how the initial cradle-to-grave file is populated and cal requirements (TÜV SÜD 2018).
reviewed at a high level. The verification stage aims to UL is a global safety certification company and has
fulfil a thorough review of the cradle-to-grave file con- published one specific standard for AM, addressing the
tents, including part design, material properties, environmental, health, and safety concerns from the
testing and inspection criteria, AM process details, facility and material aspects. One specific standard, UL
witness/hold points, and final part applications. The 3400, aims to provide guidance on the investigation of
pre-production validation stage aims to conduct, AM facility safety management. This standard indicates
monitor, and review the processes stated in the verifica- the various hazards associated with materials, equip-
tion stage. The printing of production parts, reference ment, and facilities e.g. fire, explosion, and toxic
parts, test samples, and test artifacts is performed exposure. It also includes recommendations for the
according to agreed procedures and monitored to design, installation, and maintenance of powder-based
show repeatability within assigned values and toler- AM facilities. This specific standard has been utilised as
ances. The adequate completion of testing and inspec- the basis of AM testing and certification programmes
tion regimen ensures the process qualification. The for AM facility safety management (UL Standards 2020).
cradle-to-grave file will be converted to a qualified In addition to the publications developed by qualifica-
status after satisfactory completion of the manufactur- tion and certification organisations, there are numerous
ing, testing, and inspection. Finally, the purpose of the programmes, codes, practice benchmarks, industrial spe-
production stage is to set up a robust monitoring and cifications, and handbooks under development as sup-
quality control plan. The maintenance of a qualified plementary documents that support metal AM rules
AM process requires gathering and analysing all record- and regulations. The qualification and certification organ-
able parameter data indicated in the qualified cradle-to- isations not only adopt international standards devel-
grave file. The whole qualification process is managed oped by ISO/ASTM as references but also develop
on a project basis with clear deliverable targets in the further guidelines/specifications for specific products
predetermined timeline, which is cost-effective for the and the applications in marine & offshore, oil & gas, trans-
emerging metal AM qualification. portation & mobility, engineering, and healthcare.
LR and The Welding Institute have worked in partner-
ship to update their guidance notes for the certification
of products produced by AM processes and the qualifica- 3. Current challenges and frameworks
tion of AM facilities since 2016. The latest guidance notes
3.1. Challenges
for AM certifications developed by the partnership were
published in 2020 (LR and TWI 2020), including the qualifi- The identified challenges of metal AM progression are in
cation of metal AM facilities and processes and the the aspects of education, design, materials, in-situ
VIRTUAL AND PHYSICAL PROTOTYPING 393

monitoring, post-processing, repeatability, traceability, aerospace industry is rapidly growing with early metal
standards, etc. (Thomas-Seale et al. 2018). Most of the chal- AM adoption, benefiting from existing rigorous quality
lenges, except for education, hinder the qualification and frameworks and multiple well-established standards for
certification of metal AM. For example, there is no single AM qualification and certification (Williams and Butler-
software tailored for design, simulation, build preparation, Jones 2019); oil & gas and marine industries are still at
build process, and final inspection, hence the fragmented an early stage and utilise metal AM as an alternative sol-
software is one of the biggest obstacles to form an inte- ution to fabricate non-critical parts with a few newly
grated metal AM ecosystem. Table 3 shows the main chal- released standards/rules/regulations (Section 2.2) (Siree-
lenges of metal AM qualification and certification. sha et al. 2018); healthcare and biomedical industries are
The primary challenge for qualification and certifi- tightly associated with the physical safety of human
cation is that the process to qualify and certify various beings, and standards/rules/regulations for commercial
metal AM applications is not well established. This chal- qualification and certification are still under develop-
lenge burdens commercial organisations with high cost ment (Yeong and Chua 2013; Javaid and Haleem 2018).
and prolonged lead time due to inadequate types and Challenges on the qualification and certification of
quantity of standards/rules/regulations. For example, materials originate from their development, insufficient
AM projects with a significant amount of testing and characterisation techniques, and a lack of applicable
survey for qualification and certification may cost up to standard specifications (NIST 2013). Only a few standard
millions of dollars in approximately a two-year time specifications have been developed for several powder
frame (Tryon et al. 2020). Different industries have materials such as Ti6Al4V, Inconel 718, Inconel 625,
experienced dissimilar stages of challenges in the qualifi- and 316L (Table 1 and Figure 2) for the PBF process.
cation and certification process. For example, the Powder characteristics such as the degree of sphericity,
particle size distribution, chemical composition, and
Table 3. Challenges of metal AM qualification and certification flowability have a crucial impact on the printability and
(NIST 2013; Go et al. 2017; Bae, Diggs, and Ramachandran the quality of the products. However, there is a lack of
2018; Melia et al. 2020; Panwisawas, Tang, and Reed 2020; rigorous and comprehensive understanding on the
Swerim 2020). relationship between material characteristics, printing
Item Description
processes, and final product quality for the qualification
Qualification and Guidelines currently not standardised (types
certification process and quantity not defined) High cost and
and certification of materials.
prolonged lead time. Lack of rules and Challenges on the reliability and repeatability of
regulations for wide variation applications. metal AM processes are ascribed to their point-by-
Materials Lack of standard specifications for material
characterisation: flowability of powders; point, line-by-line, and layer-by-layer fashions to print
particle size distribution of powders; wire a part, which is significantly different from conventional
filament requirements; recycling of used
powders criteria; material characteristics, processes (e.g. casting, powder metallurgy, and forging)
process printability, and product quality (Feucht et al. 2020). The complicated metallurgical
requirement.
Process reliability and Lack of deep understanding of metallurgical process with multiple physical and chemical reactions
repeatability physical and chemical reaction basis: heat during the printing of each layer brings great difficulty
source powder interactions; hierarchical
microstructure; heat transfer and
in the consistency of each printable layer (DebRoy
vaporisation; defect formation; quantitative et al. 2018; Panwisawas, Tang, and Reed 2020). There-
metallography; in-situ monitoring on real- fore, process control and feedback are crucial to the
time closed-loop process control. Non-
standardised equipment. reliability and repeatability of metal AM products.
Post-processing Lack of technical solutions for inner channels Other factors, such as inadequate in-situ real-time moni-
post-processing. Lack of post-processing
specification requirements (e.g. heat toring, non-standardised equipment, and the gap of
treatment). high-throughput scaled-up manufacture bring greater
Data Lack of databases for the process–
microstructure–property relationship, open challenges for the process control (Go et al. 2017;
databases including historical and statistical Melia et al. 2020). Several challenges have been ident-
performance and developed materials
properties, information to capture printing
ified regarding the implementation of in-situ monitoring
process data, and pedigree data including in AM processes. Major challenges include the selection
existing processes and printing history, of the optical and lighting system, the creation of a
process control, and materials.
Standards and protocols Limited available qualification standards; lack speckled pattern, the issue of high radiation especially
of protocol for round-robin testing on in DED and PBF processes, significant particle projection
materials and products; incomplete
inspection and test standards, insufficient during DED, the difficulty in camera position in PBF
non-destructive evaluation techniques for (Cunha, Santos, and Xavier 2021), and the dynamics of
complex parts.
keyhole pore formation (Huang et al. 2021).
394 Z. CHEN ET AL.

A lack of the specifications of post-processing, includ- approach to guarantee and deliver quality services with
ing heat treatments, surface finish, and the removal of essential requirements by addressing challenges proac-
supporting structures, leads to challenges in the reliable tively. Well-established frameworks enable various
usage of the final metal AM products. A heat treatment organisations in the metal AM value chain (e.g. design &
specification can achieve a stable microstructure that simulation services, materials suppliers, service bureaus
results in the steady service performance of a product, of printing, original equipment manufacturers, post-pro-
which has not been standardised for metal AM products. cessing providers, sub-suppliers of hardware and soft-
The surface finish for complex parts, especially for their ware) to identify current issues, adopt the best practice,
inner surface areas and the removal of supporting struc- and implement continuous improvement along with
tures on the printed parts are challenging and need metal AM technology evolution.
standardised specifications (Williams 2018).
The lack of a valid database for the process-micro- 3.2.1. QMS framework
structure-property relationship burdens the progress of ISO 9001 is the most extensively adopted quality man-
the qualification and certification. Challenges emerging agement system (QMS) for the manufacturing industry,
within the metal AM ecosystem include the reliability thus being employed in metal AM for quality assurance
of open-source data (e.g. the performance of the devel- and production consistency. Additionally, there are
oped materials and the statistical and historical perform- some other QMSs to match upstream and downstream
ance records of part service), the collection of non- organisations for metal AM particularly in the aerospace
standardised process data (e.g. printing and post-pro- and biomedical industries (e.g. AS 9100 and ISO 13485)
cessing parameters), and the lack of specifications to (Gibbons and Van der Merwe 2019). According to the
establish pedigree database (e.g. materials character- ISO 9001 standard, there are seven sections to be estab-
istics, process control, process and fabrication history, lished for a QMS framework of metal AM, i.e. the context
and part properties) (Swerim 2020). of organisation, leadership and commitment, planning,
Standards and protocols are lacking in the qualifica- support, operation, performance evaluation, and con-
tion and certification of printing processes, equipment, tinuous improvement (ISO 2016; Chua, Wong, and
materials, and printed parts. Standards are commonly Yeong 2017).
taken as reference or guidelines, while protocols set The context of metal AM organisation consists of
compulsory requirements. Most metal AM processes external and internal factors. The external factors
are still at the early stage of development, and inter- include technology advancements and limitations, the
national standards organisations and committees (such market of interest, the economy, and existing industry
as ISO/ASTM) need a long time to investigate and stan- infrastructure, etc. The internal factors consist of
dardise the processes with tremendous efforts. The pro- product and service offering, values, assets (e.g. facilities
tocol of round-robin testing (a set of independent tests and equipment), and resource and knowledge capabili-
to determine the reproducibility of a test method and ties. For the establishment of the QMS framework for
the reliability of a product or a process) for metal AM, metal AM in an organisation, there are still abundant
which is indispensable for various processes and equip- technological challenges on materials, process reliability
ment in the qualification of functional parts, has not and repeatability, post-processing, and data (listed in
been established. The defects in metal AM parts, such Table 3). Thus, innovation and internal research and
as cracks, porosity, lack of fusion, inclusions, and residual development are crucial to the context of the organis-
stresses, may reduce the mechanical performance of ation. The internal factors should be seamlessly linked
printed products (e.g. low strength and elongation due with the external factors by collaborating with industrial
to porosity, inclusions, and cracks as well as distortion specification development communities (e.g. NASA,
due to residual stresses) (Lewandowski and Seifi 2016; AMS, AWS, and API) to clarify the challenges in metal
Sames et al. 2016). Unfortunately, limitations of detec- AM production.
tion techniques (e.g. non-destructive testing) for Leadership and commitment from the top manage-
complex, dense, or large structures hinder the establish- ment are critical for metal AM organisations to sustain-
ment of inspection standards for the defect detectability ably invest in the knowledge of machine, process and
of the printed parts (Dutton et al. 2020). materials, design, inspection and testing, product per-
formance analysis along with a continuous funding on
hardware, software, and human resources. The
3.2. Quality frameworks
implementation of metal AM technology requires a
Quality frameworks have been developed by metal AM prudent integration of available interdisciplinary collab-
communities to mandate a consistent and integrated orations and resources to establish the QMS framework
VIRTUAL AND PHYSICAL PROTOTYPING 395

through the effective leadership and commitment most organisations that adopt metal AM as a new
within an organisation (Srivatsan and Sudarshan 2015). technology, such as the resistance from engineers
For example, in the biomedical industry, a deep under- and designers who prefer traditional manufacturing
standing on intrinsic interactions between materials methods. These constraints can be converted to the
and AM processes is essential to bringing about capabilities of the organisations by introducing metal
effective cooperation between engineers and biologists, AM as a supplementary technology to overcome the
which can be realised through strong leadership within drawbacks of the traditional methods. External
an organisation or between different organisations. In supporting resources (e.g. hardware and software,
addition, the top management should satisfy customer training, and consultancy) can be obtained to establish
needs while identifying risks and opportunities, as well personal competency and infrastructure capability pro-
as initiate, implement and disseminate quality policies. gressively along with organisation development in
The primary purpose of planning is to address risks and different stages.
opportunities for metal AM QMS, which are consistent The plan-do-check-act (PDCA) cycle is another frame-
with the context of organisation and expectations from work to help an organisation with QMS. Figure 6 depicts
customers. Risks are associated with the challenges in the four stages of ‘plan’, ‘do’, ‘check’, and ‘act’ in the
metal AM, such as inaccurate and inefficient design context of metal AM to maintain the product quality
tools represented via some file formats (e.g. standard tes- and customer satisfaction. In the PDCA cycle, the feasi-
sellation language) and defects derived from insufficient bility evaluation of metal AM in the plan stage should
process control and inspection techniques (Dutta, Babu, be primarily conducted based on available resources,
and Jared 2019b). Strategies used to deal with these existing regulations to fulfil certain specifications (e.g.
risks can include risk avoidance by proper design evalu- technology feasibility, design evaluation, and technical
ation, risk elimination by improving the process control, requirement negotiation). Subsequently, applicable AM
changing the consequences by developing suitable equipment, materials, and post-processing should be
inspection techniques, etc. Opportunities in metal AM selected with the consideration of the risks and opportu-
come from the desirable potential to address the nities. Corrective actions (e.g. failure analysis on metal
demands of organisations and their customers, which AM defects) should be taken when nonconformities of
can lead to adopting new practices, launching new pro- product performance occur, or negative customer feed-
ducts, searching for new customers, establishing partner- back is received. An integrated PDCA cycle enables the
ships, and realising research and development improvement of metal AM processes with robustness
innovation. Other purposes of planning include establish- and the reduction of defects in final products.
ing quality objectives and proposing changes.
Internal and external resources are determined and 3.2.2. Qualification and certification framework
provided by organisations to support the metal AM In the field of metal AM, a qualification and certification
QMS with the consideration of capabilities and con- framework that is utilised to identify processing factors
straints. Internal existing resources (e.g. personal com- and their influences on product performance can be
petency and infrastructure) may become constraints in developed by metal AM experts from external parties

Figure 6. A PDCA cycle integrated with metal AM.


396 Z. CHEN ET AL.

to professionalise the QMS of metal AM and control risks. specification, properties for functional applications,
The qualification and certification framework that con- and printing process requirements. Material qualification
sists of specific standards, rules, and regulations for and certification address the challenge of the character-
industrial applications is essential to ensure that the pro- isation of feedstocks. There have been a few standards
ducts can be designed and manufactured according to available for the characterisation of materials in the
the standardised requirements of metal AM. Table 4 aspects of chemistry, morphology, density, particle size
summarises the critical aspects (e.g. technology, distribution, and flowability (shown in Table 4). A fulfil-
design, materials, printing processes, post-processing, ment approach integrates these existing standards to
and inspection and testing), which are required to be aid the qualification and certification of material charac-
established within the qualification and certification fra- terisation for metal AM. For instance, wire feedstock sub-
mework of metal AM as well as their scope and activities, jected to type approval can be tested according to
related standards/rules/regulations, and deliverable manufactures’ specifications for the chemistry, dimen-
documentation. It provides potential practical sion, and mechanical properties of printed samples (BV
approaches to address the challenges of metal AM qua- 2019). The related documentation includes material spe-
lification and certification (shown in Section 3.1). cification and safety data sheets, certification of confor-
The technology of metal AM brings uncertainties that mity, and testing reports.
imply risks to developers, manufacturers, vendors, oper- The printing processes focus on operations (e.g.
ators, and end-users (DNV GL 2013). Technology qualifi- installation of equipment and accessory facilities, per-
cation provides a systematic approach to ensure sonal training, and facility control) and printing activities
traceability throughout a technology, which is deter- (e.g. printing parameter setting, sample and part print-
mined by functions, targets, and expectations of the rel- ing, in-process monitoring). The qualification of printing
evant failure modes, qualification activities, and processes can be divided into two sub-stages, i.e. facility
evidence; technology assessment is to determine the accreditation and printing activities qualification, which
elements that require technology qualification and to could be qualified simultaneously or individually. Facility
identify the key challenges and uncertainties of engaging accreditation is for AM service bureaus, especially new
metal AM. A fulfilment approach (DNVGL-RP-A203) devel- startups without production orders. The approval of
oped by DNV for the qualification and assessment of manufacturers for metal AM production is a kind of
novel technology can be potentially applied to metal schemes to accredit the facility and printing activities
AM. The approach provides key documentation required seamlessly. For instance, the approval of manufacturer
during the qualification of metal AM, including the com- scheme from DNV (CP-0346) is a classification society’s
position of the technology and sub-system, risk assess- programme to verify manufacturers’ ability to consist-
ment with the specification of personnel competence ently manufacture materials and products according to
and failure mode register, qualification evidence, the the related specifications and rule requirements (DNV
description and justification of methods applied in qua- GL 2016). Typical documentation to support the printing
lification activities, system reliability, etc. process qualification includes QMS certificates, materials
The design for metal AM should fulfil functional, tech- stock and handling procedures, manufacturing pro-
nical, and quality requirements from customers, as well cedures, and personal training records.
as specific statutory and regulatory requirements (Dura- The post-processing of metal AM products mainly
kovic 2018). Design qualification and approval (e.g. refers to heat treatment, surface finishing, and perform-
potential failure modes, consequences, and likelihood) ance improvement (Kumbhar and Mulay 2018). The qua-
are required to assess the requirements of specific appli- lification of post-processing is required to ensure the
cations before finalising the design intent and material final product performance. Only a few existing standards
specification (LR and TWI 2020). Standards, rules, or are available, such as AMS 7000, which focuses on HIP for
regulations developed by ISO/ASTM (52910, 52911, L-PBF parts. ISO/ASTM have been developing standards
F3413), ASME (Y14.46, Y14.47), DNV (CP-0267), and LR on methods and requirements of post-processing for L-
(TWI Guidance notes) can be used as a benchmark for PBF parts. The approach for fulfilling the qualification of
the guidance and assessment of the design. The docu- post-processing with limited standards is more flexible
mentation for the design qualification consists of as compared to that for fulfilling printing process qualifi-
defined design requirements, part geometry and calcu- cation. For instance, end-users can define post-processing
lations, engineering models, inspection and test plans, requirements, and suppliers can establish post-processing
printing layout, and risk analysis. methodology for the approval of the end-users.
The materials for metal AM are mainly in the form of Inspection and testing are the most important aspect
wire, powder, or sheet, which should fulfil the design during the establishment of the qualification and
VIRTUAL AND PHYSICAL PROTOTYPING 397

Table 4. Critical aspects of qualification and certification for metal AM (IACS 2011; DNV GL 2013, 2016, 2017a, 2017b, 2021; BV 2019).
Critical
aspects Scope and activities Standards, rules and regulations Documentation
Technology Technology assessment. Technology Standards for data (ISO/ASTM 52915). Risk assessment (e.g. failure mode register).
qualification. Recommended practice for technology System reliability results. Qualification
assessment and qualification (DNVGL-RP- evidence.
A203).
Design Statutory and regulatory requirements. General design principle (ISO/ASTM52910, Defined design requirements. Part geometry
Functional, technical and quality ISO/ASTM52911-1, ASME Y14.46, ASME and calculations. Build layout and
requirements. Potential failure modes, Y14.47). DED (F3413). DNVGL-CP-0267, Engineering drawings/models. Risk analysis
consequences and likelihood of failure due TWI-LR guidance notes. (high level). Inspection and test plan (high
to the application requirements. level).
Materials Feedstock materials (e.g. powder or wire). Apparent density (ISO 3923-1/-2, ASTM B212, Powder characterisation results. Wire testing
Supporting materials (e.g. base material, B329, B417). Tap density (ISO 3953, ASTM results. Material specification. Material
additives for composite alloy, gases). B527). Flowability (Hall flowmeter, ISO safety data sheet. Material certification of
4490 or ASTM B213; Carney flowmeter, conformity.
ASTM B964; Gustavsson flowmeter, ISO
13517; measuring the angle of repose, ISO
4324). Particle size distribution (ISO 2591-
1, 4497, ASTM B214, B215; laser diffraction,
ISO 13320; light scattering, ISO 22412,
ASTM B822; image analysis ISO 13322-1/2;
Power particle morphology, ISO 3252 or
ASTM B243, ISO 3954).
Printing Facility audit (AM equipment, supporting QMS standard (ISO 9001, AS9100, ISO QMS certificate. Materials stock and handling
process system) and facility control (QMS, facility 13485). Manufacturing control (ISO/ASTM procedure. Manufacturing procedures.
procedures, work instructions, 52904). Process related guidance (ASTM Personal training records. Approval of
manufacturing control). Personal F2924, F3001, F3049, F3055, F3056, F3184, manufacturer.
competency. Printing parameters. F3187, F3213, F3301, F3302, F3318, F3434,
Qualification sample and part builds. In- ISO/ASTM52904, ISO/ASTM 52907). Facility
process monitoring. Requalification. safety management (UL3400). Approval of
manufacturer scheme (DNVGL-CP-0346).
Post- Removal from build space. Heat treatment. Specification (AMS 7000). End-user technical Post-processing documentation. Equipment
processing Build platform separation. Mechanical requirements. procedure (e.g. capability, calibration
finishing. schedule & records). Personal training
records.
Inspection Direct inspection. Process qualification. Test method standards (ASTM F2971, F3122, Record of inspection equipment used for
and testing Mechanical testing. Metallurgical testing. ISO/ASTM 52902). Qualification standards measuring and testing (e.g. calibration
Non-destructive examination. Control of (VDI 3405-2, MSFC-STD-3716/3717, AWS certificate). Testing reports (e.g.
non-conforming items. Acceptance of D20, GB/T 35022-2018). Reference specific metallographic examinations, mechanical
deviations. Corrective and preventive application standards and guidance tests, NDE). Personal training records.
actions. (DNVGL-CP-0267, CP-0291, ST-B203, CG-
0197; NI662 DT R00 E). Reference guidance
notes (ABS, TWI LR).

certification framework and should be carried out at all modeling can be utilised to investigate the likelihood
stages of product development. Test sample locations, of metal powder disturbance by the eddy current
defect mechanisms, acceptance of deviations, and sensor electromagnetic field and real-time data acqui-
long-term reliability in metal AM products are different sition for in-situ inspections (Zhakeyev et al. 2017;
from those for conventionally manufactured counter- Todorov 2020).
parts (Vander Voort 2001; Tobar et al. 2010; Keane Some organisations have applied their developed
2016; Baerwaldt 2018; Bonanno et al. 2018; Masete, qualification and certification frameworks to produce
Muchavi, and Chikosha 2018; Smith 2018). The standard- metal AM products in the fields of aerospace, marine
isation of inspection and testing is the leading work of and offshore, etc. A metal fuel nozzle printed by
international standards and certification organisations. General Electric (GE) for a leading-edge aviation propul-
A number of test methods and qualification standards sion engine received dual certifications from the FAA
have been developed (e.g. ASTM F2971, F3122; ISO/ and EASA, which significantly improved aircraft hard-
ASTM 52902; VDI 3405-2; MSFC-STD-3716, 3717, AWS ware component production and engine shipment
D20, and GB/T 35022), which can be supplemented (Russell et al. 2019). Within the certification framework,
with specific standards and guidance developed by cer- a printed T25 sensor housing for compressor inlet temp-
tification organisations (e.g. DNVGL-CP-0267, CP-0291, erature monitoring was approved to be applied in the
ST-B203, CG-0197, and NI662 DT R00 E). The integration GE90 jet engine (Russell et al. 2019). NASA has been
of the developed standards and state-of-the-art inspec- actively preparing AM components, such as injectors
tion technologies can be used to fulfil the challenges and combustion chambers printed and tested by the
raised from metal AM. For instance, computational Marshall Space Flight Centre with internal qualification
398 Z. CHEN ET AL.

and certification procedures in rocket engines (Gradl The qualification and certification of metal AM are
et al. 2018). In the marine and offshore industry, hindered by critical challenges in the aspects of
leading certification organisations (e.g. DNV, BV, and design, materials, in-situ monitoring, post-processing,
LR) have qualified and certified industrial functional repeatability, traceability standards, etc. The primary
parts based on the standards, rules, and regulations challenge is that the qualification and certification
listed in Table 4. Thyssenkrupp Tech Center Additive process is underdeveloped for many applications due
Manufacturing received the certificate for the approval to high cost, prolonged lead time, as well as inadequate
of metal AM production from DNV in 2019 (Tess 2019). types and quantity of standards, rules, and regulations.
Later, Sembcorp Marine received certifications from Other challenges are mainly due to the lack of in-situ
DNV, which qualified its AM procedures and specifica- monitoring on real-time close-loop process control,
tions for products in the field of construction and insufficient data, and the process reliability and repeat-
repair (Sembcorp Marine 2019). AML Technology and ability that result from limited research on heat source-
3D Metalforge received the certification of metal AM powder interactions, heat transfer and vaporisation,
facility from LR (LR 2018; Metal AM 2018). A metal AM defect formation, quantitative metallography, etc.
propeller for shipbuilding (WAAMpeller) was developed The qualification and certification framework of metal
by RAMLAB, Promarin, Autodesk, and Damen and is the AM is proposed and discussed to address challenges
world’s first metal AM class approved by BV (Damen proactively and is utilised to identify processing factors
2017). and their influences on product performance. Compar-
ing with the universal applicability of the QMS frame-
work, the qualification and certification framework
4. Conclusion and outlook requires more expertise in metal AM technology and
product application specialisation. The framework con-
4.1. Conclusion
sists of specific standards, rules and regulations for
A comprehensive review on the status and pathway of industrial applications in several critical aspects (e.g.
the qualification and certification of metal AM is technology, design, materials, printing processes, post-
carried out. It is a timely summary to provide guidance processing, and inspection and testing). Such a frame-
for the commercialisation of the scientific and techno- work can mandate a consistent and integrated approach
logical achievements of metal AM. The qualification of to guarantee and deliver quality services with essential
metal AM is to evaluate a prototype design, material, requirements for metal AM products. A well-establish
and product during their development or testing, framework not only overcomes the challenges for qua-
which can include a technique, machine, material, part, lification and certification but also sets benchmarks to
or even supplier. Certification of metal AM can be estab- accelerate the metal AM adoption by demonstrating a
lished for the satisfaction of authority, which applies to a cost-effective qualification and certification process.
part, component, product, and their evaluation process
as well as a system during or at the end of develop-
4.2. Outlook
ment/production. Qualification and certification can be
interchanged in most cases as both are inextricably Current qualification and certification methodologies
interwoven with each other and rely on the standards, are predominantly conveyed from conventional manu-
rules, and regulations. International and national stan- facturing processes (e.g. casting, forging, and powder
dards organisations are actively involved in the develop- metallurgy), which results in high cost and long lead
ment of standards, rules, and regulations for metal AM to time due to a tremendous amount of physical testing
accelerate its standardisation process. Representative and survey involved (Kandukuri and Chen 2021). More
organisations, such as ISO, ASTM, NASA, SAE AMS, importantly, qualification and certification method-
ASME, AWS, API, VDI, IEEE, DNV, BV, LR, ABS, UL, and ologies in the conventional manufacturing processes
TÜV SÜD, have devoted themselves to the qualification may not be suitable for metal AM. The outlook for the
and certification of metal AM. Among these organis- qualification and certification for metal AM can focus
ations, ISO and ASTM have played a leading role for on a digital methodology, which addresses the features
the development of metal AM standards through their of metal AM as part of industrial digital transformation. A
collaboration with 28 published and 60 under develop- perspective pathway of digital qualification and certifi-
ment (Tables 1 and A1). The topics of these standards cation can be proposed for future research, as shown
include terminology and general principle, materials in Figure 7.
and processes, design, test methods, and qualification The digital qualification and certification for metal
principle. AM can be expected from two aspects, i.e. data-
VIRTUAL AND PHYSICAL PROTOTYPING 399

Figure 7. Outlook for digital qualification and certification for metal AM.

based digital process monitoring and digital transform- with industrial communication networks. For example,
ation of processes. The fundamentals of the qualifica- a tighter processing window and tolerance control can
tion and certification implementation of digital be achieved by machine learning with the perquisition
process monitoring can generate an open-source data- of production engineering knowledge, which involves
base (e.g. using cloud technology) of printing process industrial information technology and artificial neural
parameters, material-process-microstructure-property networks. Consequently, little human intervention will
relationship, and statistical and historical product per- be involved for future process modification to prevent
formance. The qualification and certification of digital possible faults and deviations. Trust, traceability, and
process monitoring can be achieved by data-driven security are critical aspects in metal AM qualification
in-situ process inspection. The process inspection can and certification, i.e. blockchain technology that can
assess the geometry and temperature of melt pools, be utilised to decentralise and distribute the material
residual stresses, inclusions, porosity, cracks and moment and status information along the metal AM
warping in each printing layer, and part shrinkage supply chain among related stakeholders. Finally,
during solidification, which can be captured in real remote survey based on cyber-physical systems can be
time and then converted into records in a visible and used to make the qualification and certification
readable data format. Moreover, the data-driven process more cost-effective and efficient as future
process-microstructure-property correlation and metal AM ecosystems will be globalised. For example,
product performance prediction provide another a live stream survey can be easily verified by other
effective way to monitor product quality proactively. parties in case of any dispute, and the digital records
Based on printing parameters, statistical and historical are retrievable.
data of product performance can be predicted for qua- Metal AM digital transformation is the evolution
lification and certification benchmark reference. Data- version of the data-based digital process monitoring,
based digital process monitoring can produce reports rather than recording the defects and predicting the
of real-time defects and predict failures in printed pro- product performance. The implemented digital trans-
ducts, which can be utilised as qualification and certifi- formation will proactively minimise the defects and
cation documents. improve the product performance with limited human
Integration of digital transformation with metal AM intervention. Consequently, it will relieve the burden at
will magnify the benefits of each, which will be crucial the final stage of metal AM qualification and certification
to the implementation of digital qualification and certifi- with enhanced efficiency and transparency.
cation. Machine learning can enable the quality control It is hoped that the recent works on the qualification
of metal AM products with successful engagement and certification of metal AM will boost more research
400 Z. CHEN ET AL.

interests and efforts into the topic, and thereby acceler- America Makes & ANSI Additive Manufacturing
ating the standard adoption of metal AM in a broad Standardization Collaborative (AMSC), June: 1–269.
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Disclosure statement
Additive Manufacturing.” Accessed March 2, 2021. https://
No potential conflict of interest was reported by the author(s). ww2.eagle.org/content/dam/eagle/rules-and-guides/current/
other/299-gn-on-additive-manufacturing-2018/additive-
manufacturing-gn-sept18.pdf.
Funding American National Standards Institute (ANSI). 2011. “ISO and
ASTM to Cooperate on International Standards for
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Board, Singapore and DNV GL Singapore Pte. Ltd through March 2, 2021. https://www.ansi.org/news/standards-
the Industrial Postgraduate Programme with Nanyang Techno- news/all-news/2011/10/iso-and-astm-to-cooperate-on-inter
logical University, Singapore, and the National Research Foun- national-standards-for-additive-manufacturing-26 ().
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Nanyang Technological University, Singapore. He has worked product-definition-additive-manufacturing/2017/drm-enabled-
on projects for metal additive manufacturing industrialization, pdf.
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Appendix

Table A1. Summary of proposed ISO/ASTM AM standards related to metal AM (ASTM International 2020; ISO 2020). ‘WK’, ‘WD’, ‘CD’,
and ‘DIS’ are the abbreviations of work items, working drafts, committee drafts, and draft international standards, respectively.
Proposed new ISO/ASTM standards under development
Topic Code Simplified title with reflecting on standard scope
General principle ISO/ASTM DIS 52900 Fundamentals and vocabulary
ISO/ASTM DTR Non-destructive testing of AM products
52905
ISO/ASTM DIS 52921 Standard practice for part positioning, coordinates and orientation
Materials and processes WK65937 Space application-Flight hardware made by PBF-LB process
WK65929 Finished part properties and post-processing spaceflight hardware by PBF-LB in metals
WK62190 AM feedstock materials technical specifications on metal powder
WK65420 Guideline for IQ/OQ/PQ of PBF-LB equipment for production manufacturing
WK69730 Wire for DED processes in AM
WK69732 New Guide Wire Arc Additive Manufacturing
WK72317 PBF – Multiple energy sources
ISO/ASTM AWI Standard specification for quality assurance and post-processing of PBF metallic parts
52908
ISO/ASTM WD TS Guideline for IQ/OQ/PQ of PBF-LB equipment for production manufacturing
52930
Design WK48549 AMF Support for solid modeling: Voxel information, constructive solid geometry representations and
solid texturing
WK62867 Guide for design for material extrusion processes
WK64190 Design – Decision guide
WK71507 General principles – Overview of data processing
WK72938 Design – Part 3: Electron-based PBF of metals
WK73444 Design – Post-processing
WK74006 Data formats – Specification for optimised medical image data
ISO/ASTM WD Design – Part 3: Standard guideline for Electron-based PBF of metals
52911-3
ISO/ASTM TR 52912 Design – Functionally graded AM
Test methods WK66030 Quality assessment of metal powder feedstock characterisation data for AM
WK49229 Orientation and location dependence mechanical properties for metal AM
WK55610 The characterisation of powder flow properties for AM applications
WK70207 Test method of sand mould for metal casting – Part 2: Physical properties
WK56649 Standard practice/guide for intentionally seeding flaws in AM parts
WK66029 Mechanical testing of polymer AM materials
WK70206 Test method of sand mould for metal casting – Part 1: Mechanical properties
WK69371 Standard practice for generating mechanical performance debits
WK69731 NDT for use in DED AM processes
WK71393 Assessment of powder spreadability for PBF processes
WK71395 Accelerated quality inspection of build health for laser beam PBF process
WK66682 Evaluating post-processing and characterisation techniques for AM part surfaces
ISO/ASTM AWI Test artifacts – Geometric capability assessment of AM systems
52902
ISO/ASTM CD TR NDT and evaluation – Standard guideline for intentionally seeding flaws in parts
52906
ISO/ASTM WD Test method of sand mould for metalcasting – Part 1: Mechanical properties
52919-1
ISO/ASTM WD Test method of sand mould for metalcasting – Part 2: Physical properties
52919-2
ISO/ASTM FDIS System performance and reliability – Acceptance tests for laser metal PBF machines for metallic materials
52941 for aerospace application
ISO/ASTM WD Round robin testing – Guidance for conducting round-robin studies
52917
Qualification principle ISO/ASTM WD Requirements for industrial AM sites
52920
ISO/ASTM WD Part 1: Qualification of machine operators for metallic parts production
52926-1
ISO/ASTM WD Part 2: Qualification of machine operators for metallic parts production for PBF-LB
52926-2
ISO/ASTM WD Part 3: Qualification of machine operators for metallic parts production for PBF-EB
52926-3
ISO/ASTM WD Part 4: Qualification of machine operators for metallic parts production for DED-LB
52926-4
ISO/ASTM WD Part 5: Qualification of machine operators for metallic parts production for DED-Arc
52926-5
ISO/ASTM WD Qualification of coordinators for metallic parts production
52935
Data WK73978 Data registration

(Continued)
VIRTUAL AND PHYSICAL PROTOTYPING 405

Table A1. Continued.


Proposed new ISO/ASTM standards under development
Topic Code Simplified title with reflecting on standard scope
WK72172 General principles – Overview of data pedigree
ISO/ASTM WD Data formats – Standard specification for optimised medical image data
52916
ISO/ASTM CD TR Data formats – File format support, ecosystem and evolutions
52918
ISO/ASTM DIS 52950 Overview of data processing
Applications WK66637 4340 Steel via PBF-LB for transportation and heavy equipment industries
WK67583 Powder reuse schema in PBF processes for medical applications
WK70164 Standard practice for assigning part classifications for metallic materials
WK72659 Guideline for material process validation for AM of medical devices
WK71891 AM of Ti6Al4V ELI (Extra Low Interstitial) with PBF for medical devices
WK73231 Acceptance tests for PBF machines for metallic materials for aerospace application
WK73688 Generic machine evaluation and KPI for LPBF-M processes in automotive applications
ISO/ASTM AWI Orientation and location dependence of mechanical properties for metal PBF
52909
Environment, health and WK73227 Investigation for AM facility safety management
safety ISO/ASTM CD 52931 Standard guideline for use of metallic materials

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