Aerospace series - Requirements for Advanced Product Quality Planning and Production Part Approval Process

This standard establishes requirements for performing and documenting APQP and PPAP. APQP begins
with conceptual product needs and extends through product definition, production planning, product
and process validation (i.e. PPAP), product use, and post-delivery service. This standard integrates and
collaborates with the requirements of the EN 9100, EN 9102, EN 9103 and EN 9110 standards.
The requirements specified in this standard are complementary (not alternative) to contractual and
applicable statutory and regulatory requirements. Should there be a conflict between the requirements
of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.

Luft- und Raumfahrt - Anforderungen an die Produktqualitätsvorausplanung und das Produktionsteil-Freigabeverfahren

Série aérospatiale - Exigences pour une planification avancée de la qualité produit et un processus d’approbation des pièces de production

Aeronavtika - Zahteve za napredno načrtovanje kakovosti izdelkov in proces odobravanja proizvodnih delov

Ta standard določa zahteve za izvajanje in dokumentiranje naprednega načrtovanja kakovosti izdelkov (APQP) ter procesa odobravanja proizvodnih delov (PPAP). Napredno načrtovanje kakovosti izdelkov temelji na konceptualnih potrebah po izdelkih in zajema opredelitev izdelkov, načrtovanje proizvodnje, validacijo izdelkov in postopkov (npr. PPAP), uporabo izdelkov ter storitev po dostavi. Ta standard upošteva in uporablja zahteve standardov EN 9100, EN 9102, EN 9103 ter EN 9110.
Zahteve iz tega standarda dopolnjujejo (niso alternativna možnost) pogodbene in ustrezne zakonske ter regulativne zahteve. V primeru neskladnosti med zahtevami iz tega standarda in ustreznimi zakonskimi ali regulativnimi zahtevami imajo prednost ustrezne zakonske ali regulativne zahteve.

General Information

Status
Published
Publication Date
14-Nov-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
08-Nov-2018
Due Date
13-Jan-2019
Completion Date
15-Nov-2018

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SLOVENSKI STANDARD
SIST EN 9145:2019
01-januar-2019
$HURQDYWLND=DKWHYH]DQDSUHGQRQDþUWRYDQMHNDNRYRVWLL]GHONRYLQSURFHV
RGREUDYDQMDSURL]YRGQLKGHORY

Aerospace series - Requirements for Advanced Product Quality Planning and Production

Part Approval Process
Luft- und Raumfahrt - Anforderungen an die Produktqualitätsvorausplanung und das
Produktionsteil-Freigabeverfahren

Série aérospatiale - Exigences pour une planification avancée de la qualité produit et un

processus d’approbation des pièces de production
Ta slovenski standard je istoveten z: EN 9145:2018
ICS:
03.120.01 Kakovost na splošno Quality in general
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
SIST EN 9145:2019 en,fr,de

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

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SIST EN 9145:2019
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SIST EN 9145:2019
EN 9145
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2018
EUROPÄISCHE NORM
ICS 03.120.10; 49.020
English Version
Aerospace series - Requirements for Advanced Product
Quality Planning and Production Part Approval Process

Série aérospatiale - Exigences pour une planification Luft- und Raumfahrt - Anforderungen an die

avancée de la qualité produit et un processus Produktqualitätsvorausplanung und das

d'approbation des pièces de production Produktionsteil-Freigabeverfahren
This European Standard was approved by CEN on 28 August 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

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

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

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9145:2018 E

worldwide for CEN national Members.
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SIST EN 9145:2019
EN 9145:2018 (E)
Contents
Page

Rationale ........................................................................................................................................................................... 4

Foreword .......................................................................................................................................................................... 4

0 Introduction ...................................................................................................................................................... 5

0.1 General ................................................................................................................................................................ 5

0.2 Application ........................................................................................................................................................ 6

1 Scope .................................................................................................................................................................... 7

1.1 Purpose ............................................................................................................................................................... 7

1.2 Convention ......................................................................................................................................................... 7

2 References ......................................................................................................................................................... 7

3 Terms and definitions ................................................................................................................................... 8

4 Advanced product quality planning requirements ......................................................................... 13

4.1 General requirements ................................................................................................................................ 13

4.2 Advanced product quality planning project management ............................................................ 13

4.3 Phase 1 requirements – planning ........................................................................................................... 14

4.4 Phase 2 requirements – product design and development .......................................................... 15

4.5 Phase 3 requirements – process design and development ........................................................... 16

4.6 Phase 4 requirements – product and process validation .............................................................. 18

4.7 Phase 5 requirements – on-going production, use and post-delivery service ....................... 20

5 Production part approval process requirements............................................................................. 21

5.1 Process requirements for production part approval process ..................................................... 21

5.2 Production part approval process file and submission ................................................................. 22

5.3 Production part approval process disposition .................................................................................. 22

5.3.1 Production part approval process submission disposition .......................................................... 22

5.3.2 Recording the production part approval process disposition ..................................................... 22

5.4 Production part approval process resubmission ............................................................................. 22

(informative) Acronym log ................................................................................................................... 23

(informative) Advanced product quality planning phase activities, deliverables

and outputs ..................................................................................................................................................... 25

(informative) Control plan .................................................................................................................... 30

C.1 Phases of the control plan ......................................................................................................................... 30

C.2 Content of the control plan ....................................................................................................................... 30

(informative) Production part approval process approval form ........................................... 31

Figures
Figure 1 — Product development process and advanced product quality planning

(conceptual illustration) ............................................................................................................................ 6

Tables

Table 1 — Acceptance criteria for process capability studies ................................................................... 20

Table 2 — Production part approval process file contents ......................................................................... 21

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SIST EN 9145:2019
EN 9145:2018 (E)
European foreword

This document (EN 9145:2018) has been prepared by the Aerospace and Defence Industries

Association of Europe - Standardization (ASD-STAN).

After enquiries and votes carried out in accordance with the rules of this Association, this Standard has

received the approval of the National Associations and the Official Services of the member countries of

ASD, prior to its presentation to CEN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by April 2019, and conflicting national standards shall be

withdrawn at the latest by April 2019.

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

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

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
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SIST EN 9145:2019
EN 9145:2018 (E)
Rationale

This standard was created to define the aviation, space and defence process requirements for Advanced

Product Quality Planning (APQP) and Production Part Approval Process (PPAP). The APQP aspects of

this standard define a methodology for ensuring that the product development processes deployed

throughout the aviation, space and defence industries are fully integrated phased processes that extend

from concept and design through manufacturing process planning and execution and on into product

use, service and customer feedback. The PPAP is an output of APQP confirming that the production

process has demonstrated the potential to produce products that consistently fulfil all requirements at

the customer demand rate.
Foreword

To assure customer satisfaction, the aviation, space and defence industry organizations must produce

and continually improve safe, reliable products that equal or exceed customer and regulatory authority

requirements. The globalization of the industry and the resulting diversity of regional / national

requirements and expectations have complicated this objective. End-product organizations face the

challenge of assuring the quality of and integration of product purchased from suppliers throughout the

world and at all levels within the supply chain. Industry suppliers face the challenge of delivering

product to multiple customers having varying quality expectations and requirements.

The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG)

for the purpose of achieving significant improvements in quality, delivery, safety and reductions in cost,

throughout the value stream. This organization includes representation from companies in the

Americas, Asia / Pacific and Europe.

This document standardizes the requirements for the Product Development Process (PDP) through the

use of APQP and PPAP methodologies. The establishment of common requirements, for use at all levels

of the supply chain, should result in the elimination or reduction of organization unique requirements

and the resulting variation inherent in the multiple expectations.

This document has been developed by IAQG to cover a wide domain of global applicability (Aerospace &

Defence); please be informed that some standards have been developed by CEN to cover specifically

space systems (e.g. CEN/CENELEC TC5 EN 166XX series). For European space applications these

standards may be taken into account.
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SIST EN 9145:2019
EN 9145:2018 (E)
0 Introduction
0.1 General

This standard specifies requirements in a structured framework to plan and complete actions of the

product realization cycle which are necessary to ensure quality product(s) are delivered on time, while

satisfying cost performance targets. APQP drives a quality focused approach to product development

through the use of a phased planning process within which specific deliverables are established,

monitored and tracked to closure, while highlighting and mitigating risks as they are identified. PPAP is

an output of APQP confirming that the production process has demonstrated the potential to produce

products that consistently fulfil all requirements while operating at the customer demand rate.

Successful implementation of APQP requires: management commitment and support from the

beginning of the product development cycle and multidisciplinary project teams integrating all

stakeholders and delivering a committed timeline for executing planned activities.

APQP has five phases (conceptually illustrated in Figure 1) starting with conceptual product needs and

extending throughout the product life cycle. The actual duration of each phase will differ depending

upon the scope and timing of the specific product and/or production development project. These

phases are described as follows:
• Phase 1 – Planning:

The goal of this phase is to capture customer inputs, benchmark data, lessons learned, regulatory

requirements, technical specifications, company know-how and strategy into a product concept and

realization plan. This includes identification of the high-level technical, quality and cost targets.

• Phase 2 – Product Design and Development:

The goal of this phase is to translate the technical, quality and cost requirements into a controlled,

verified and validated product design. Design validation is achieved using prototype, development,

or production parts in test environments that can represent the customer’s installation and subject

the product to extreme conditions required by contract or regulation.
• Phase 3 – Process Design and Development:

The goal of this phase is to design and develop the production processes needed to produce product

that consistently fulfil technical, quality and cost requirements while operating at the customer

demand rate.
• Phase 4 – Product and Process Validation:

The goal of this phase is to validate that product fulfils the design requirements and the production

processes have demonstrated the capability to consistently produce conforming product at the

customer demand rate. Product validation is achieved using product produced from the defined

production processes.
• Phase 5 – On-going Production, Use and Post-delivery Service:

The goal of this phase is to ensure customer requirements are continually fulfilled through the use

of process control, lessons learned and continuous improvement.
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SIST EN 9145:2019
EN 9145:2018 (E)
Figure 1 — Product development process and advanced product quality planning
(conceptual illustration)
0.2 Application

This standard applies to new product development efforts, but can also be applied to products currently

in production where changes are planned. It can be applied to the final product or selected levels of

parts (i.e. parts within an assembly as defined by the organization or customer). When this standard is

flowed down as a general contractual requirement (i.e. not for a specific program or project), the scope

of applicability is established between the organization and the customer.

This standard is generally not applied to standard parts or Commercial-off-the-Shelf (COTS) items.

Producers and their suppliers are responsible for flow down of the requirements of this standard, as

appropriate, to suppliers who design and/or produce product.

When this standard is invoked, APQP and PPAP shall continue to apply when previously approved

products and processes undergo change (e.g. introduction of a new production process, change to

existing production process, change of production source, addition to the existing production sources).

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SIST EN 9145:2019
EN 9145:2018 (E)
1 Scope

This standard establishes requirements for performing and documenting APQP and PPAP. APQP begins

with conceptual product needs and extends through product definition, production planning, product

and process validation (i.e. PPAP), product use, and post-delivery service. This standard integrates and

collaborates with the requirements of the EN 9100, EN 9102, EN 9103 and EN 9110 standards.

The requirements specified in this standard are complementary (not alternative) to contractual and

applicable statutory and regulatory requirements. Should there be a conflict between the requirements

of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.

1.1 Purpose

The purpose of this standard is to establish a uniform approach to product realization across the

aviation, space and defence industry ensuring that quality products are delivered on time, while

satisfying cost performance targets.
1.2 Convention
The following conventions are used in this standard:
 the word “shall” indicates a requirement;

 the word “should” indicates a recommended action (content or path), but not mandatory

application;

 words “typical”, “example”, “for reference” or “e.g.” indicate suggestions given for guidance only;

 “NOTES” are used for additional clarification;

 words or phrases with specific meaning pertaining to this document are defined in 3 (Terms and

definitions).
2 References

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

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

EN 9100, Quality Management Systems — Requirements for Aviation, Space and Defence Organizations

EN 9102, Aerospace series — Quality systems — First article inspection requirements

EN 9103, Aerospace series — Quality management systems — Variation management of key

characteristics

EN 9110, Quality Management Systems — Requirements for Aviation Maintenance Organizations

EN ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

NOTE Equivalent versions (e.g. AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published

internationally in each sector.
IAQG Supply Chain Management Handbook (SCMH) – http://www.sae.org/iaqg/:
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SIST EN 9145:2019
EN 9145:2018 (E)
 Advanced Product Quality Planning (APQP);
 Aerospace Advanced Product Quality Planning (APQP) Manual.

Advanced Product Quality Planning and Control Plan; APQP Second Edition; Automotive Industry

Action Group (AIAG); www.aiag.org.
ASTM E 2782, Guide for Measurement Systems Analysis (MSA)

IEEE 1490:2011, Guide — Adoption of the Project Management Institute (PMI) Standard; “A Guide to the

Project Management Body of Knowledge (PMBOK Guide)” — Fourth Edition; www.ieee.org

SAE J1739, Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode

and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA)
3 Terms and definitions

Definitions for general terms can be found in EN ISO 9000 and the IAQG International Dictionary

(located on the IAQG website). An acronym log for this document is presented in Annex A. For the

purpose of this standard, the following definitions apply:
3.1
Bill of Material
BOM
list of components and materials contained in the design record(s) of a product
3.2
Commercial Off-The-Shelf
COTS

commercially available products, defined by industry recognized specifications and standards, sold

through public catalogue listings
3.3
control plan

documented description linking manufacturing process steps to key inspection and control activities.

The intent of a control plan is to control the design characteristics and the process variables to ensure

product quality
3.4
Critical Item

those items (e.g. functions, parts, software, characteristics, processes) having significant effect on the

product realization and use of the product; including safety, performance, form, fit, function,

producibility, service life, etc.; that require specific actions to ensure they are adequately managed.

Examples include: safety CIs, fracture CIs, mission CIs, Key Characteristics (KCs) and maintenance tasks

critical for safety (reference EN 9103 standard)
3.5
customer

organization, legal entity, or person that receives a product or service (e.g. consumer, client, end-user,

retailer, beneficiary, purchaser)
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SIST EN 9145:2019
EN 9145:2018 (E)
3.6
deliverables
items (outputs) completed as part of the APQP process
3.7
demand rate

quantity of products required to be produced by the production organization over a specified period of

time to fulfil the delivery schedule
3.8
design characteristic

those dimensional, visual, functional, mechanical and material features or properties, which describe

and constitute the design of the article, as specified by drawing or Digital Product Definition (DPD)

requirements. These characteristics can be measured, inspected, tested, or verified to determine

conformance to the design requirements. Dimensional features include in-process locating features (e.g.

target-machined or forged / cast dimensions on forgings and castings, weld / braze joint preparation

necessary for acceptance of finished joint). Material features or properties may include processing

variables and sequences, which are specified by the drawing or DPD (e.g. heat treat temperature,

fluorescent penetrant class, ultrasonic scans, sequence of welding and heat treat). These provide

assurance of intended characteristics that could not be otherwise defined (reference EN 9102 standard)

3.9
design records

records of the engineering definition / specification, which fully define the product (system, part,

component, or assembly), including physical or electronic / digital drawings, electronic / digital models,

software, or other associated information; This includes records of authorized engineering changes not

yet incorporated into the released engineering definition / specification
3.10
design risk analysis

analytical techniques used by the design responsible organization to identify, to the extent possible,

potential failure modes related to product performance (i.e. fit, form and function), durability,

manufacturability and cost
3.11
Failure Mode and Effects Analysis
FMEA

structured method for analysing risk by ranking and documenting potential failure mode in a system,

design, or process
The analysis includes:
 identification of potential failures and their effects;

 ranking of factors (e.g. severity, frequency of occurrence, detectability of the potential failures); and

 identification and results of actions taken to reduce or eliminate risk.

The FMEA assists in the identification of CIs as well as key design and process characteristics, helps

prioritize action plans for mitigating risk and serves as a repository for lessons learned. Examples

include: system FMEA, interface FMEA, design FMEA and process FMEA.
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SIST EN 9145:2019
EN 9145:2018 (E)
3.12
Inspection / test plan

detailed description of inspection and test activities (e.g. tolerances, methods, gages) for features or

attributes to be performed during specific manufacturing operations
3.13
Key Characteristic

attribute or feature whose variation has a significant influence on product fit, performance, service life

or producibility; that requires specific action for the purpose of controlling variation (reference

EN 9103 standard)
This definition is further explained as follows:

 KCs for a part, subassembly, or system are those selected geometrical, material properties,

functional and/or cosmetic features; which are measurable and whose variation control is

necessary for fulfilling customer requirements and enhancing customer satisfaction;

 process KCs are those selected measurable characteristics of a process whose control is essential to

manage variation of part or system KCs.

Substitute KCs may be identified when a customer-defined KC is not readily measurable, within the

production / maintenance setting and other characteristics may need to be controlled to ensure

conformance.
3.14
Measurement Systems Analysis
MSA

study of the effects of selected elements of a measurement process (i.e. people, machines, tools,

methods, materials, environment) on accuracy, precision and uncertainty of measurement

3.15
phase

period of time (during the PDP) in which specific processes, tasks, deliverables and outcomes of APQP

occur; phases may overlap as illustrated in Figure 1; The end of a phase is indicated by fulfilment of

phase deliverables (see Annex B)
3.16
post-delivery service

service rendered to the customer or to end users in support of the product's successful continuing use.

This includes, but is not limited to, providing documents (e.g. maintenance manuals, service bulletins),

product use training, repair or overhaul activity, service hot lines and spare parts provisioning

3.17
pre-design

set of design related activities that establishes a preliminary concept design based upon the product

specifications and requirements; This may include sketches, drawings and physical or mathematical

models that provide an understanding of the principle of operation and a high-level product structure

3.18
Preliminary Bill of Material (BOM)

initial BOM completed, prior to design validation and release of design record, for production use

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EN 9145:2018 (E)
3.19
preliminary capacity assessment

assessment performed early in the process planning and development phase to determine resources

(e.g. people, equipment, facilities) necessary to produce product at the customer demand rate

3.20
process capability study

study that compares the output of an in-control process to the specification limits, expressed in terms of

process capability index (e.g. Cpk) or as a process performance index [e.g. Ppk, parts per million (PPM)]

3.21
product breakdown structure
high-level bill of material (BOM)

breakdown of a product into its subsystems and major components; it is used to support early planning

activities, including sourcing decisions
3.22
Product Development Process
PDP

generically applied term referring to an organization’s process(es) for product realization. The process

begins with conceptual product needs and expands throughout the life of the product. Common

milestones include: kick-off, end of concept [i.e. preliminary design review (PDR)], design release [i.e.

Critical Design Review (CDR)], initial production approval and production launch (see Figure 1)

3.23
Production Part Approval Process (PPAP) file
file containing objective evidence in support of PPAP requirements
3.24
production preparation plan

plan that identifies all resources (e.g. production and test / inspection equipment, tooling, jigs, fixtures,

computing processes, materials, supply chain, trained work force, facilities) required to produce a

product in sufficient quantity to satisfy the customer demand rate; additionally, it defines the timing of

the release of work instructions, operator training and commissioning of the machines

3.25
Production Readiness Review
PRR

review of the manufacturing process (e.g. equipment, operator training, manufacturing documentation,

control plan, associated measurement tools) by a multi-disciplinary team to verify that the production

processes are appropriately defined, documented and ready for production
3.26
special requirements

those requirements identified by the customer or determined by the organization, which have high

risks of not being achieved, thus requiring their inclusion in the risk management process; Factors used

in the determination of special requirements include product or process complexity, past experience,

and product or process maturity; Examples of special requirements include performance requirements

imposed by the customer that are at the limit of the industry’s capability, or requirements determined

by the organization to be at the limit of its technical or process capabilities (reference EN 9100 and

EN 9110 standards)
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EN 9145:2018 (E)
3.27
stakeholder

individual or organization having a right, share, claim, or interest in a system or in its possession of

characteristics that meet their needs and expectations; Stakeholders include, but are not limited to:

customers, suppliers, regulatory bodies and functional organizations or groups involved in product

realization
3.28
standard part

parts for which the design, manufacturing, inspection data and marking requirements necessary to

demonstrate conformity to the part are in the public domain and published / established as part of

...

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