SIST EN 9145:2019

SLOVENSKI STANDARD
SIST EN 9145:2019
01-januar-2019
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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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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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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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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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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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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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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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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
CI
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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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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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
KC
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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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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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
...