Programme Management - Definition justification and qualification - A guide to drawing up the definition justification plan and of the definition justification dossier

This document sets forth the general rules applying to the justification of the definition of a product (tangible or intangible) and specifies the content of the Definition Justification Plan (DJP) and the Definition Justification Dossier (DJD).
It is applicable to all products designed and developed to fulfil the requirements of a customer expressed in a (Need) Technical Specification. Industrials are advised to apply the following principles to their own needs for justification in their internal customer/supplier relations.
Clause 5 presents the concepts and the documents associated with the justification of the definition and qualification processes.
Clause 6 summarizes the role and the contractual nature of the qualification of the definition.
Clause 7 gives details of the qualification of the definition process, while Clause 8 positions this process in the programme development logic.
The document also describes the differences between the justification and the qualification of the definition and other notions, such as verification, validation or acceptance (Clause 9).
Clause 10 is a guide to the establishment and maintenance of the documents associated with the justification of the definition and qualification processes. Information related to the certification process, even if it is out of the scope of the present document, is also presented in Clause 10, because this process has certain similarities with the justification of the definition and qualification process.
This document belongs to the documents supporting the EN 9200 relating to Project Management Specification.

Programm-Management - Festlegung, Nachweis und Qualifikation - Richtlinien zur Erstellung des Konstruktionsstands-Nachweisplans und der Konstruktionsstands-Nachweisunterlage

No Scope available

Management de programme - Justification et qualification de la définition - Guide pour l'élaboration du plan de justification de la définition et du dossier de justification de la définition

Le présent document fixe les règles générales relatives à la justification de la définition d'un produit (tangible ou intangible) et précise les contenus du plan de justification de la définition (PJD) et du dossier de justification de la définition (DJD).
Il est applicable à tout produit conçu et développé pour satisfaire aux exigences d'un client exprimées dans une spécification technique de besoin. Il est recommandé aux industriels d’appliquer les principes ci-dessous pour leurs propres besoins de justification dans le cadre de relations client/fournisseur internes.
L’Article 5 présente les concepts et les documents associés aux processus de justification et de qualification de la définition.
L’Article 6 rappelle le rôle et le caractère contractuel de la qualification de la définition.
L’Article 7 détaille le processus de qualification de la définition alors que l’Article 8 positionne ce processus dans la logique de déroulement d’un programme.
Le document présente également les différences entre la justification et la qualification de la définition et les autres notions telles que vérification, validation ou acceptation (Article 9).
L’Article 10 est une aide pour l’établissement et le maintien des documents liés aux processus de justification et de qualification de la définition. Bien qu’en dehors du périmètre du présent document, des informations associées au processus de certification sont également présentées à l’Article 10 car ce processus présente des similitudes avec le processus de justification et de qualification de la définition.
Le présent document fait partie des documents d'accompagnement de la norme EN 9200 relative à la spécification de management de programme.

Upravljanje programov - Definicija upravičenosti in razvrščanja - Vodilo za pripravo načrta za definicijo upravičenosti in dokumentacije definicije upravičenosti

General Information

Status
Not Published
Publication Date
11-Jul-2023
Current Stage
6055 - CEN Ratification completed (DOR) - Publishing
Start Date
02-Jan-2023
Completion Date
02-Jan-2023

Buy Standard

Draft
prEN 9215:2020 - BARVE
English language
33 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 9215:2020
01-oktober-2020
Upravljanje programov - Definicija upravičenosti in razvrščanja - Vodilo za
pripravo načrta za definicijo upravičenosti in dokumentacije definicije
upravičenosti

Programme Management - Definition Justification and Qualification - A guide to drawing

up the definition justification plan and of the definition justification dossier
Programm-Management - Festlegung, Nachweis und Qualifikation - Richtlinien zur
Erstellung des Konstruktionsstands-Nachweisplans und der Konstruktionsstands-
Nachweisunterlage

Management de Programme - Justification et Qualification de la Définition - Guide pour

l'élaboration du plan de justification de la définition et du Dossier de justification de la

Définition
Ta slovenski standard je istoveten z: prEN 9215
ICS:
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
oSIST prEN 9215:2020 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN 9215:2020
---------------------- Page: 2 ----------------------
oSIST prEN 9215:2020
DRAFT
EUROPEAN STANDARD
prEN 9215
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2020
ICS 49.020
English Version
Programme Management - Definition Justification and
Qualification - A guide to drawing up the definition
justification plan and of the definition justification dossier

Management de Programme - Justification et Programm-Management - Festlegung, Nachweis und

Qualification de la Définition - Guide pour l'élaboration Qualifikation - Richtlinien zur Erstellung des

du plan de justification de la définition et du Dossier de Konstruktionsstands-Nachweisplans und der

justification de la Définition Konstruktionsstands-Nachweisunterlage

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee ASD-

STAN.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 9215:2020 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)
Contents Page

European foreword ...................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 List of acronyms............................................................................................................................................... 8

5 Presentation of the associated concepts and documents ................................................................. 8

5.1 Qualification of the document .................................................................................................................... 8

5.1.1 Purpose of the qualification of the definition ....................................................................................... 8

5.1.2 Difference from other types of qualification ......................................................................................... 9

5.2 Justification of the definition .................................................................................................................... 10

5.2.1 Concept ............................................................................................................................................................. 10

5.2.2 Differences with other related notions ................................................................................................. 10

5.3 Justification of the producibility of the definition ............................................................................ 12

6 Role and contractual nature of the qualification of the definition ............................................. 12

7 Definition qualification process .............................................................................................................. 14

7.1 General .............................................................................................................................................................. 14

7.2 Establishment of the DJP by the supplier ............................................................................................. 14

7.3 Approval of the DJP by the customer ..................................................................................................... 14

7.4 Justification works and elaboration of the DJD by the supplier .................................................. 15

7.5 Acceptance of the DJD and the MIJF by the customer ...................................................................... 15

7.6 Qualification tests by the customer ........................................................................................................ 15

7.7 Qualification review (QR) .......................................................................................................................... 16

7.8 Qualification pronouncement .................................................................................................................. 16

8 Positioning of the qualification process in the phasing and scheduling ................................... 17

8.1 General case: product without certification and with a designated customer ....................... 17

8.2 Specific cases .................................................................................................................................................. 18

8.2.1 Partial qualification of the definition .................................................................................................... 18

8.2.2 Reuse of components off-the-shelf (COTS) .......................................................................................... 19

8.3 Qualification according to the level of the product breakdown structure............................... 19

9 Verification and validation (V&V) versus definition justification and qualification ........... 20

10 Production and content of the associated documents ..................................................................... 22

10.1 Production and content of the DJP .......................................................................................................... 22

10.1.1 Production of the DJP .................................................................................................................................. 22

10.1.2 Content of the DJP ......................................................................................................................................... 22

10.2 Production and content of the DJD ......................................................................................................... 23

10.2.1 Production of the DJD .................................................................................................................................. 23

10.2.2 Content of the DJD ......................................................................................................................................... 23

10.3 Changes to the justification ....................................................................................................................... 24

10.4 Definition justification versus certification ........................................................................................ 25

Annex A (informative) An example of the presentation of a Definition Justification Plan —

DJP ...................................................................................................................................................................... 30

---------------------- Page: 4 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)

Annex B (informative) An example of the presentation of a Design Justification Dossier —

DJD ...................................................................................................................................................................... 31

Bibliography ................................................................................................................................................................. 33

---------------------- Page: 5 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)
European foreword

This document (prEN 9215:2020) 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 document is currently submitted to the CEN Enquiry.
---------------------- Page: 6 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)
1 Scope

This document sets forth the general rules applying to the justification of the definition of a product

(tangible or intangible) and specifies the content of the Definition Justification Plan (DJP) and the

Definition Justification Dossier (DJD).

It is applicable to all products designed and developed to fulfil the requirements of a customer

expressed in a (Need) Technical Specification. Industrials are advised to apply the following principles

to their own needs for justification in their internal customer/supplier relations.

Clause 5 presents the concepts and the documents associated with the justification of the definition and

qualification processes.

Clause 6 summarizes the role and the contractual nature of the qualification of the definition.

Clause 7 gives details of the qualification of the definition process, while Clause 8 positions this process

in the programme development logic.

The document also describes the differences between the justification and the qualification of the

definition and other notions, such as verification, validation or acceptance (Clause 9).

Clause 10 is a guide to the establishment and maintenance of the documents associated with the

justification of the definition and qualification processes. Information related to the certification

process, even if it is out of the scope of the present document, is also presented in Clause 10, because

this process has certain similarities with the justification of the definition and qualification process.

This document belongs to the documents supporting the EN 9200 relating to Project Management

Specification.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

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

— ISO Online browsing platform: available at https://www.iso.org/obp/ui
— IEC Electropedia: available at http://www.electropedia.org/
3.1
document acceptance

decision by which the customer agrees that the document complies with the contractual requirements

Note 1 to entry: In the case of document acceptance, customer’s responsibility is not committed. The document

author remains responsible for its content and is in particular in charge of fixing any non-conformity detected

after acceptance decision.

Note 2 to entry: Without any response from the customer within a time limit previously specified, the document

is considered as de facto accepted.
---------------------- Page: 7 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)
3.2
product acceptance

contractual decision by which the customer agrees that the product is manufactured according to its

qualified definition and the agreed deviations and waivers, and it is free of defects when delivered by

the suppliers
3.3
certificate

document formalizing the definition approval issued by the Authority when the designer demonstrates

that the product complies with the applicable regulations
3.4
certification

acknowledgement, formalized by a certificate written internally or by an accredited third party, that the

subject of the certification conforms to specified requirements and is acceptable for operational use

Note 1 to entry: The certification may apply to a product, a service, a system, a management system or a person.

Note 2 to entry: This acknowledgement does not systematically authorize actual use. E.g.: regarding air

transports, a specific second certificate issued by national authorities is necessary for the conformance to its

operational requirements.
3.5
definition justification dossier (DJD)

document or file gathering all the information of design and tests demonstrating that the definition of

the product described in its Definition Data File fulfils all the requirements of the (Need) Technical

Specification [(N)TS]
3.6
justification of the definition

process by which the supplier collects arguments and evidence, coming from product verification and

validation activities, in order to demonstrate that the product definition fulfils all the requirements of

the customer’s (Need) Technical Specification [(N)TS]

Note 1 to entry: Evidence acquisition activities are planned in a Definition Justification Plan (DJP) submitted to

customer approval. However, DJP elements deemed design-critical regarding costs and time shall be included in

the contract and are de facto approved by the customer.

Note 2 to entry: Collected evidence and conclusions are gathered in a Definition justification dossier (DJD)

submitted to customer acceptance.

Note 3 to entry: The justification of the definition does not add specific technical activities for the supplier. It is

based on the results of the product verification and validation technical activities carried out in any case by the

supplier.
3.7
definition Justification Plan (DJP)

document presenting how and when (types of means of compliance, types of activities, etc.) will be

justified that the definition of the product fulfils all the requirements of the (Need) Technical

Specification [(N)TS]
---------------------- Page: 8 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)
3.8
qualification pronouncement

act whereby the customer certifies, on the basis of the theoretical and experimental justifications

presented by the supplier in the DJD and the Manufacturing and Control Justification File, and on the

customer’s qualification tests, that the definition of the product (contained in the Definition File) fulfils

all the requirements expressed in the (Need) Technical Specification and that this definition is

producible

Note 1 to entry: The pronouncement can be a formal document issued by the client or simply an explicit

mention in a qualification review report.
Note 2 to entry: The qualification pronouncement ends the development contract.

Note 3 to entry: This pronouncement is worth customer's commitment to the supplier regarding the qualified

definition. This definition becomes the reference definition on the basis of which the serial production specimens

are made.

Note 4 to entry: If the definition changes, because of the customer, after the qualification pronouncement and

after the production launching, the customer should bear the cost of the resumption of production related to the

changes.
3.9
qualification of the definition

process whose objective is to demonstrate that the product definition fulfils the requirements of the

(Need) Technical Specification and is producible. This process encompasses the activities of the

justification of the definition (theoretical and experimental) carried out by the supplier and activities

carried out by the customer. Customer activities consist on the one hand by the analysis of justification

of the definition elements and producibility justification elements transmitted by the supplier, and on

the other hand by so-called qualification tests in a customer environment

Note 1 to entry: The qualification tests are conducted by the customer, on samples of the product called

qualification samples, in an environment representative of the operating environment. The scenarios used during

these tests may go beyond those defined in the supplier's Definition Justification Plan (additional testing facilities,

extended domain, etc.). During these tests, the supplier may be present in support, for the implementation of the

product as part of a support service.
3.10
product validation

process which demonstrates through objective evidence (results of inspections, measurements,

analyses, tests, etc.) that the product as designed fulfils operational need in the intended operational

environment

Note 1 to entry: Validation activities may be carried out in real or simulated operational environment.

Note 2 to entry: Product validation answers the question “Has the right product been built?”

3.11
product verification

process which demonstrates through objective evidence (results of inspections, measurements,

analyses, tests, etc.) that the product as designed is compliant with specified requirements

Note 1 to entry: Product verification differs from requirements verification.

Note 2 to entry: Product verification answers the question “Is the product built right?”.

---------------------- Page: 9 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)
4 List of acronyms
AC Acceptance Conditions
AS Acceptance Specification
CDR Critical Design Review
CF Certification File
COTS Component Off-The-Shelf
CP Certification Plan
CR Certification Review
DDF Definition Data File
DDFi intermediate Definition Data File
DGA Direction Générale de l’Armement [French Directorate General for Armaments]
DJCF Design Justification Choice File
DJD Definition Justification Dossier
DJP Definition Justification Plan
FPS Functional Performance Specification
MIJF Manufacturing and Inspection Justification File
(N)TS (Need) Technical Specification
ORR Operational Readiness Review
PBS Product Breakdown Structure
PDR Preliminary Design Review
PTS Product Technical Specification
QR Qualification Review
SoW Statement of Work
TOEV Technical and Operational Evaluations
TRR Test Readiness Review
V&V Verification and Validation
WS Work Specification [Cahier des Prestations]
5 Presentation of the associated concepts and documents
5.1 Qualification of the document
5.1.1 Purpose of the qualification of the definition
For the customer, the qualification of the definition:

— ensures that the definition of the product covered by the development contract fulfils the technical

requirements of the contract; and

— uses the output from the certification process to consider the fulfilment of the regulatory

requirements of the product (see 10.4) when the product is subject to certification.

---------------------- Page: 10 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)

For the supplier, it limits the demonstration costs and enables the customer’s agreement to be obtained

on the product definition on a clear and negotiated basis from the very start of the contract.

The pronouncement of the qualification of the definition formally recognizes the success of the

development and constitutes the milestone representing the end of the development contract.

It constitutes an “OK to series production” on the basis of the qualified definition.

5.1.2 Difference from other types of qualification

The term “qualification” could not be used without specifying the purpose to be qualified, because

qualification covers a number of diverse notions that it is important to distinguish from one another.

Unlike the qualification of the definition, operational qualification (see Figure 4) corresponds to the use

of the product in the operational environment. Operational qualification covers the Technical and

Operational Evaluations (TOEV) made by the end user (the supplier may provide support). The purpose

of operational qualification is to demonstrate that the product:
— is operable in an operational context and environment;

— possesses the expected operational capabilities (a capability is described by a set of operational

scenarios and processes representative of the use cases of the product); and

— achieves a level of performance required by the users (according to criteria, measurements, service

levels, etc., defined by the users).

Operational qualification is established on the basis of the operational concept document, and in

particular the description of the operational scenarios.

The pronouncement of the qualification of the definition is a prerequisite of operational qualification.

The product subject to operational qualification is a representative sample of the series definition or the

first article. Operational qualification can be pronounced by the buyer and the users (decision to adopt)

after the operational readiness review (ORR).

The purpose of the qualification of the production system is to demonstrate that the production

system is capable of producing samples of the product in keeping with its definition and the objectives

of the programme at controlled risk levels. The qualification of the production system takes place in

parallel and is consistent with the qualification of the definition. The qualification of the production

system takes account of the requirements of industrialization and of the manufacturing rules.

The approach to the qualification of the production system guarantees that the factors of the industrial

process (procedures, means of manufacturing and integration, means of inspection, the environment)

are operated under controlled conditions and can guarantee the compliance and the reproducibility of

the products. The qualification of the production system is established on the basis of the

manufacturing and inspection justification file (MIJF). The supplier can pronounce the qualification of

the production system at the end of a review.

The qualification of a manufacturing process attests that the process fulfils the specified

requirements (characteristics, level of performance, reliability, etc.) on the basis of the evidence

produced. It is a part of the qualification of the production system.

Reduced qualification is a material qualification relative to a subset of requirements for resistance to

the environment, on a complete product or on a representative part of the product. When such a

qualification takes place, it is one of the steps of the qualification of the definition. Under conditions of

minimal safety, it enables intermediate milestones (e.g. first flight readiness, etc.) to be passed.

Material qualification is the complete qualification of one or more items of equipment in relation to

the requirements for resistance to the environment. It is part of the qualification of the definition (see

the RTCA DO-160, for example).
---------------------- Page: 11 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)
5.2 Justification of the definition
5.2.1 Concept

Justification of the definition is a part of the efforts made to control development costs.

The justification of the definition of a product consists of providing evidence and proof demonstrating

that the product definition fulfils the requirements to be met.

To this end, the supplier proposes an approach that justifies the product definition. This approach

consists in:

— reaching a common agreement on the requirements, or even the objectives, contained in the (need)

technical specification ((N)TS) and in the regulation, for which justification of the product

definition is necessary, and ensuring that they are properly and identically understood;

— identifying the risks of failing to fulfil the requirements or failing to achieve the objectives, and

estimating their gravity and probability of occurrence; and

— by common agreement, producing a common framework of reference for the elaboration of the

documents to provide, i.e.:

— the Definition Justification Plan (DJP), which precises how and when each response to the

expressed requirements will be justified (nature of the work to be done and the corresponding

resources), in view of the identified and accepted risks;

— the Definition Justification Dossier (DJD), which provides access to the agreed justification

information and contains a review of the justifications acquired.

For products subject to certification, the supplier makes sure that the proposed approach includes all

the factors associated with the certification process in order to optimize the justifications (studies, tests,

documentation, etc.) and to make sure they are consistent with the needs expressed by the customer

and the Authorities (see 10.4).

The arguments and evidence, based on the results of the verification and validation works of the

product (see Clause 9), collected by the supplier during the development of the product and compiled in

the DJD, contribute to the pronouncement of the qualification of the definition of this product by the

customer.

The justification of the definition is based on theoretical factors, experimental factors, experience

acquired in similar developments and the supplier’s know-how. If necessary, it takes the justifications

already obtained for the constituent parts of the product concerned into consideration.

5.2.2 Differences with other related notions
5.2.2.1 Justification of the definition versus requirements justification

The justification of the definition shall not be confused with, and bears no direct relation to, the

requirements justification.

The purpose of the requirements justification of a requirements specification document (Functional

Performance Specification (FPS), (N)TS, Product Technical Specification (PTS), etc.) is to:

— trace and validate the requirements in relation to the requirements of a higher level, by making

sure that they are implemented correctly and completely; and
---------------------- Page: 12 ----------------------
oSIST prEN 9215:2020
prEN 9215:2020 (E)

— explain the choices and compromises made for each requirement (functional analysis of the need,

negotiations with the potential suppliers, results of works resulting in the allocation of

performances, etc.).
5.2.2.2 Definition Justification versus Design Choice Justification

The justification of the definition does not explain the reasons for choosing one solution rather than

another but it is the demonstration, based on evidence, that the requirements expressed by the

customer in the (N)TS are fulfilled by the chosen solution.

The purpose of the design choice justification (information included in the design choice justification

file – DJCF) is to provide all the information required to select alternative(s) that fulfil the requirements.

To this end, the design choice justification can be used:

— to establish the choices and hypotheses to be adopted, as well as the counter-proposals, in view of

the various possible solutions;

— to choose the best solution by, in particular, considering the criteria that are, or are not, specified in

the programme (design-to-cost, integration of value analysis, identification of improvements,

options / constraints, maturity of the technology, etc.);

— to trace the options of the definition and the decisions that led to the reference solution described

in the definition data file (DDF); and

— in the reviews (programme, requirements, architecture, etc.), to help to reach a decision by

providing the necessary justifications of the elements produced in the DDF.

The data associated with the design choice justification forms an integral part of the knowledge and

know-how of the industrial. It is essential to always protect this knowledge and nev

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.