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Page 1: QUALITY MANUAL QM V - ihfelectronics.comihfelectronics.com/iacobucci/news/AS9100...ISO9001.pdf · quality manual qm v issue : 1 amdt.: ... 7.1.2 risk management 56 7.1.3 configuration

Section 1 QQMM VV

Amdt. 1 Rev. Orig.

30 Nov 2015

AASS//EENN 99110000 Page 1 of 95

QQUUAALLIITTYY MMAANNUUAALL QQMM VV

Issue : 1 Amdt.: Original November 2015

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Section 1 QQMM VV

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Table of content

Table of content 2

Introduction 5

I. Top management statement 6

II. Revision Table 8

III. Compliance Table 9

IV. Relevant processes and their correlation 12

V. Company presentation 13

1. SCOPE 14

1.1. GENERAL 14

1.2. APPLICABILITY 15

2. NORMATIVE REFERENCE 15

3. DEFINITIONS 15

4. QUALITY MANAGEMENT SYSTEM 19

4.1 GENERAL REQUIREMENTS 19

4.2 DOCUMENTATION REQUIREMENT 20

4.2.1 GENERAL 20

4.2.2 QUALITY MANUAL 22

4.2.3 CONTROL OF DOCUMENTS 23

4.2.4 CONTROL OF RECORDS 24

5. MANAGEMENT RESPONSIBILITY 26

5.1 MANAGEMENT COMMITMENT 26

5.2 CUSTOMER FOCUS 26

5.3 QUALITY POLICY 27

5.4 PLANNING 28

5.4.1 QUALITY OBJECTIVES 29

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 29

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5.5. RESPONSIBILITY, AUTHORITY AND COMMUNICATION 30

5.5.1. RESPONSIBILITY AND AUTHORITY 30

5.5.2 MANAGEMENT REPRESENTATIVE 41

5.5.3 INTERNAL COMMUNICATION 42

5.6. MANAGEMENT REVIEW 43

5.6.1 GENERAL 43

5.6.2 REVIEW INPUT 43

5.6.3 REVIEW OUTPUT 44

6. RESOURCE MANAGEMENT 45

6.1. PROVISION OF RESOURCES 45

6.2 HUMAN RESOURCES 45

6.2.1 GENERAL 45

6.2.2 COMPETENCE, TRAINING AND AWARENESS 46

6.3 INFRASTRUCTURE 48

6.4 WORK ENVIRONMENT 50

7. PRODUCT REALIZATION 52

7.1 PLANNING OF PRODUCT REALIZATION 53

7.1.1 PROJECT MANAGEMENT 55

7.1.2 RISK MANAGEMENT 56

7.1.3 CONFIGURATION MANAGEMENT 58

7.2 CUSTOMER RELATED PROCESS 61

7.2.1 DETERMINATION OF REQUIREMENT RELATED TO PRODUCT 62

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT 63

7.2.3 CUSTOMER COMMUNICATION 63

7.3 DESIGN AND DEVELOPMENT 65

7.4.1 PURCHASING PROCESS 71

7.4.2 PURCHASING INFORMATION 71

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7.4.3 VERIFICATION OF PURCHASED PRODUCT 71

7.5 PRODUCTION AND SERVICE PROVISION 71

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION 71

7.5.1.1 PRODUCTION PROCESS VERIFICATION 71

7.5.1.2 CONTROL OF PRODUCTION PROCESS CHANGES 71

7.5.1.3 CONTROL OF PRODUCTION EQUIPMENT, TOOLS AND SOFTWARE PROGRAMS 71

7.5.1.4 POST-DELIVERY SUPPORT 71

7.5.2 VALIDATION OF PROCESS FOR PRODUCTION AND SERVICE PRODUCTION 71

7.5.3 IDENTIFICATION AND TRACEABILITY 71

7.5.4 CUSTOMER PROPERTY 71

7.5.5 PRESERVATION OF PRODUCT 71

7.6 CONTROL OF MONITORING AND MEASURING DEVICES 71

8. MEASUREMENT, ANALYSIS AND IMPROVEMENT 71

8.1 GENERAL 71

8.2 MONITORING AND MEASUREMENT 71

8.2.1 CUSTOMER SATISFACTION 71

8.2.2. INTERNAL AUDIT 71

8.2.3. MONITORING AND MEASUREMENT OF PROCESSES 71

8.2.4 MONITORING AND MEASUREMENT OF PRODUCT 71

8.3 CONTROL OF NON CONFORMING PRODUCT 71

8.4 ANALYSIS OF DATA 71

8.5 IMPROVEMENT 71

8.5.1 CONTINUOUS IMPROVEMENT 71

8.5.2 CORRECTIVE ACTIONS 71

8.5.3 PREVENTIVE ACTIONS 71

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Introduction

Iacobucci HF Aerospace (IHF) is a worldwide leader in designing and manufacturing of

Galley Inserts since 1994, and at the end of 2011 has expanded its scope of work to new

Seat Division.

The IHF production satisfies the Commercial Aviation market as well as the General

Aviation one.

Since 2006 the IHF is certified under EASA Part 21-Sub G as Production Organization

Approved and under EASA Part 145 as Maintenance Organization Approved; whereas

since 2011 is certified under EASA Part 21-Sub O as Alternative Procedure to Design

Organization Approved.

IHF is aware about the importance of the strategic choice to have a recognized Quality

Management System in compliance to the international Standard; in order to emphasize

the importance of this choose IHF has decided to be in conformity with the AS/EN9100.

This Quality Manual has been issued as consequence of up-mentioned decision.

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I. Top management statement

The IHF, CEO is aware about the strategic decision to establish, implement and

maintain a Quality Management System. It is in accordance to the Mission of the

Company:

“To be the worldwide leader in innovative technology and manufacturing of

quality cabin interiors products and services of the highest safety standards

for Commercial Airliners and General Aviation Companies”

Therefore the CEO has decided that its Quality Management System and all its

organisational processes will be conform to the Standard AS/EN 9100. All the Top

Management and the IHF personnel will strive to achieve this challenging result. This

is in order to obtain maximum benefits from the adoption of that standard in terms of:

increasing customer satisfaction;

improving visibility on the markets;

increasing accountability vs. the stakeholders;

increasing level of quality of products/services;

improving the efficiency of internal processes;

maintaining the highest standards of airworthiness and safety of its products.

The CEO declares the complete availability in term of Resources, Means and

Procedures to achieving the quality objectives. Particular emphasis, will be gave to the

expectations of customers and their continuous satisfaction, in all company processes.

Moreover the CEO wants to assure to the Third Part Body, Authorities, and Customers,

about the availability of the all personnel, to perform processes in transparent way,

including those processes carried out by Suppliers/Partner of the organization. This is

to facilitate the audits and inspections performed by the External Bodies, Authorities

and Customers in order to assess the company processes against the AS/EN9100

requirements. All the Top Management is committed to comply with the requirements

and to improve continually the effectiveness of the QMS described in this Manual.

CEO

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II. Revision Table

Rev.

Date § Change description Prepared: Verified: Approved:

Original 8 January 09 All 1st Original issuing A. Guadagnino A. Fiordelli L. Iacobucci

A Oct. 30th, 10 All

Alll

All

2

II

V

5.5.1

8.2.1

7.2.3

2nd issuing after DNV Annual Audit 2010:

Changed header Logo;

Changed company acronym: was IHE, is IHF;

Changed footer

Changed reference in chapter 2, was ISO 9001:2000 is ISO 9001:2008 (Observation, Ref. Audit DNV 16-17/02/2010);

Changed Top Management Mission, as per 21-02-2009 e-mail from Marketing & Communication;

Updated Phase 2 – Design Process (PGM is part of DO Design Review);

Updated Key Process 2 ;

Changed Key Process 4- (MOA involved in the warranty decision);

Updated Organizational Chart;

Changed chapter 8.2.1, (Add Customer Satisfaction Questionnaire);

Changed chapter 7.2.3 Customer Communication (Aligned to the Key process 4);

F. Mascioni R. Tarallo L. Iacobucci

B January 16,

2012

All Updates as per EN9100:2009

requirements

F. Mascioni R. Tarallo L. Iacobucci

C July 16 2013 All

§5.5.1

Deleted some typo errors and add list of

effective pages.

Updated as per new organization chart

F. Mascioni R. Tarallo L. Iacobucci

D May 19, 2014 All Update for Company name change. S. Cittadini R. Tarallo L. Iacobucci

E Nov 28, 2014

Changed Organization chart due to the

insert in the Production Capability List of

Non Electrical Galley Insert article

S. Cittadini F. Mascioni R. Tarallo

Amdt. Rev Date Changes description Prepared Checked Approved

1 Orig. Nov 30, 2015

Introduced handbook management

system in order to uniform to the other

QSM handbook.

§ 4.2.2 introduced the handbook update

criteria including the information to the

Customer in case of ”significant change”.

Updated Organization Chart with the

introduction of General Manager.

S. Cittadini R. Tarallo L. Iacobucci

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III. Compliance Table

The following table shows the documental correlation between the SAE AS9100

Section 1 (EN9100:200 9, Section 1) clauses and the IHF QMS procedures and process

flow charts. The complete list of the Procedures and Instructions, with the revision

level is attached to this Manual and is managed as a separate document.

9100 Section

Description Document Title

4.2.1 a) documented statement of a quality policy and quality

objectives QM V Quality Manual

4.2.2 Quality Manual QM V Quality Manual

4.2.3 Control of Documents 21-QP001 Emissione, approvazione e

modifica della documentazione

4.2.4 Control of Records 21-QP010 Compilazione e tenuta delle

registrazioni

5.1 Management Commitment QM V Quality Manual

5.2 Customer Focus QM V Quality Manual

5.3 Quality Policy Flow Chart

Support Process 6 Review & Improvement

5.4.1 Quality Objectives Flow Chart

Support Process 6 Review & Improvement

5.5.1 Responsibility and Authority QM V Quality Manual

5.5.3 Internal Communication Flow Chart

Support Process 6 Review & Improvement

5.6 Management Review Flow Chart

Support Process 6 Review & Improvement

6 RESOURCE MANAGEMENT 21-QP011 Competenza e qualificazione del

personale

6.2.2 Competence, Training and

Awareness 21-QP011

Competenza e qualificazione del personale

6.3 Infrastructure Flow Chart

Support Process 5 Work Environment

6.4 Work Environment Flow Chart

Support Process 5 Work Environment

7.1 Planning of Product

Realization 21-OP005 Processi di produzione

7.1.1 Project Management 21-ADP001 Design data management

7.1.2 Risk Management Flow Chart

Support Process 1 Gestione del Rischio

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7.1.3 Configuration Management Flow Chart

Support Process 2 Gestione della Configurazione

21-ADP001 Design data management 7.2.2

Review of Requirements Related to the Product Flow Chart

Key Process 1 Gestione vendite

Flow Chart Key Process 1/4

Gestione vendite / Gestione post vendita

7.2.3 Customer Communication 21-ADP005

Assistenza tecnica e pubblicazioni tecniche

7.3.1 Design and Development

planning 21-ADP001 Design data management

7.3.2 Design and Development

inputs 21-ADP001 Design data management

7.3.3 Design and Development

outputs 21-ADP001 Design data management

7.3.4 Design and Development

review 21-ADP001 Design data management

7.3.5 Design and Development

verification 21-OP006 Ispezione e collaudi

21-ADP001 Design data management 21-ADP003 Certification management 7.3.6

Design and Development validation

21-ADP007 Testing activity management

7.3.6.1 Design and Development verification and validation

testing 21-ADP003 Certification management

7.3.6.2 Design and Development verification and validation

documentation 21-ADP003 Certification management

7.3.7 Control of Design and Development changes

21-ADP002 Design change management

21-OP002 Qualificazione, auditing e

controllo dei fornitori 7.4.1 Purchasing Process

21-ADP006 Qualificazione e controllo dei

fornitori

7.4.2 Purchasing Information 21-OP003 Gestione Acquisti e Verifica della conformità di prodotti e/o parti in

accettazione

7.4.3 Verification of Purchased

Product 21-OP003

Gestione Acquisti e Verifica della conformità di prodotti e/o parti in

accettazione

7.5.1 Control of Production and

Service Provision 21-OP005 Processi di produzione

7.5.1.1 Production process

verification 21-OP006 Ispezione e collaudi

7.5.1.2 Control of Production Process

Changes 21-OP005 Processi di produzione

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7.5.1.3 Control of Production Equipment, Tools and Software Programs

9100-QP019 Infrastrutture e ambiente di

lavoro

7.5.1.4 Post-Delivery support 21-ADP005

MOE

Assistenza tecnica e publicazioni tecniche

Maintenance Organization Exposition

7.5.2 Validation of Processes for

Production and Service provision

21-QP006 Ispezione e collaudi

7.5.3 Identification and Traceability 21-OP004 Identificazione e rintracciabilità

7.5.5 Preservation of Product 21-OP013 Movimentazione,

immagazzinamento e imballaggio

7.6 Control of Monitoring and

Measuring Equipment 21-OP007

Taratura e controllo di apparecchiature e strumenti di

prova

8.2.1 Customer Satisfaction Flow Chart

Key Process 3 Support Process 6

Gestione post vendita & Riesame del Sistema

8.2.2 Internal Audit 21-QP014 Audit interni di qualità e Azioni

correttive

8.2.3 Monitoring and Measurement

of Processes 9100-QP017

Analisi statistica e andamento della Qualità

8.2.4 Monitoring and Measurement

of Product 21-OP006 Ispezione e collaudi

8.3 Control of Nonconforming

Product 21-OP008

Controllo degli elementi non conformi

8.4 Analysis of Data 9100-QP017 Analisi statistica e andamento

della Qualità

8.5.1 Continual Improvement Flow Chart

Support Process 6 Miglioramento continuo

8.5.2 Corrective Action 21-QP014 Azioni correttive e preventive

8.5.3 Preventive Action 21-QP014 Azioni correttive e preventive

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IV. Relevant processes and their correlation

IHF uses several processes to manage and develop work activities. Here following are identified and shown the relevant processes in the organization.

The processes are standardized in Key Processes and Support Processes.

Key Process: is a process involving the organization resources in order to realize the

Hardware, directly related to the core business of the IHF.

Support Process: Is a process performed in order to provide the indirect support to the

key processes. Generally they are not performed on regular basis but are carried out

when requested by the specific situation occurring.

Key Processes:

Key Process 1 Sales Management;

Key Process 2 Design Process

Key Process 3 Product Realization;

Key Process 4 After sales Management.

Support Process:

Support Process 1 Risk Management;

Support Process 2 Configuration Management;

Support Process 3 Purchasing Process;

Support Process 4 Suppliers Qualification;

Support Process 5 Work environment Management;

Support Process 6 System review and continuous improvement;

The following flow charts are not exhaustive of the entire number of processes

executed in the IHF. All the processes or sub processes having active role for the

Quality Management System are documented and disciplined in the procedures

recalled in this manual in the compliance table.

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V. Company presentation

Facility description

The industrial site is located in Strada SC ASI 1/S nn 16-18 - Ferentino (Frosinone).

The buildings are inside an area of 44,087 square meters, and are completely

surrounded by a court. The court is about 10,030 sqm.

The part of the area used by IHF is composed by building used for offices, areas

dedicated to production activities, maintenance activities and a bordered area as

warehouse for row material, sub-assy and finite products.

The IHF buildings area is about 4000 square meters and have the following

construction characteristics:

the framework is made up of reinforced concrete foundations on plinths;

the walls of the perimeter are made of cement and are lightened with expanded

clay;

the roof structure is made of reinforced concrete beams;

Here after there is the map of the facilities.

Facility organization

The Buildings are in line with the general requirements of environmental laws in order

to permit a good and undisturbed execution of work by staff.

The Emergency Escape Exit are routed and well identified by signals for all the area of

the buildings. The working environment is lighting by natural light and is facilitated by

neon lamps, in order to obtain a satisfactory uniform lighting.

The air conditioning is satisfactory.

Production activities consist of Final Assembly for Galley Insert, Assembly for Seat,

Incoming Inspection and Final Check. The Final Assembly of Galley Inserts is

performed by Lines, organized in “islands”, each one composed by two work benches.

The activities connected to the Seat Division are performed in an assembly area, a

test article area, a test area and a production warehouse.

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1. SCOPE

1.1. GENERAL

This document shows the IHF Quality Management System by means of the processes

of the Organization and the described functions. This is in order to manage the

Production and Maintenance of all Aeronautical Products, realized by the IHF.

A Quality Management System is instituted to achieve the complete satisfaction of:

Customers;

Stakeholders;

Authorities;

the Organization itself;

Partners and Suppliers;

and for the following purpose:

to implement the activities needed for the continuous improvement;

to guarantee the conformity of the products delivered, to the customer requirement

and Airworthiness Rules.

This Manual is considered a mandatory document from the Top Management and

should be used as reference for undertake actions, support the general principles and

the objectives contained in the IHF Quality Policy.

The document has been drawn up in conformity with the reference norms listed in

paragraph 2 and shall be considered as permanent reference to implement the

principles of the norms into the Quality Management System.

This Manual is the main document to regulate the Quality Management System of the

IHF and have to be used in concurrence to the indicated procedures and theirs

processes.

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1.2. APPLICABILITY

This document satisfies the UNI EN ISO 9001:2008, SAE AS9100 Rev. C e

EN9100:2009 requirements for the Quality Management System.

The IHF Management System regarding the EASA part 21 Sub. G, EASA part 21 Sub.

O and EASA part 145 approvals, are controlled by specific documents, but could be

supplemented also by the paragraphs of this manual and recalled procedures.

2. NORMATIVE REFERENCE

Following are listed the reference Norms of this Manual:

UNI EN ISO

9001:2008

“Quality Management Systems – Requirements"

(Edition November 2008)

UNI EN ISO

9000:2005

“Quality Management Systems – Fundamentals and Vocabulary”

(Edition September 2005)

SAE AS9100

Rev. C

Quality Management Systems- Requirements for Aviation, Space and

Defense Organization -

EN9100:2009

Aerospace series

Quality Management Systems – Requirements based on ISO

9001:2000 and Quality System

3. DEFINITIONS

PRODUCT OR SERVICE

The result of activity or job processing.

QUALITY

The total of the properties and characteristics of a product or service that grants the

capability to satisfy the explicit or implicit demands.

QUALITY POLICY

The objective and the general directions of an organization stated in a formal way

from the Top Management.

QUALITY ASSURANCE

The total of planned and systematic actions necessary to give adequate trusts that a

product or service fulfils defined requirements of quality.

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QUALITY CONTROL

The operational techniques and activities established to fulfill the requirements of

quality.

QUALITY SYSTEM

The organizational structure, the responsibilities, the procedures, the processes and

the resources established for the IHF's management of the quality.

QUALITY PLAN

Document that defines the operational modalities, the resources and the sequences of

activity that influence the quality of a defined product, service, contract or project.

QUALITY AUDIT

Systematic and independent examination to determine if the activities carried out for

the quality and the results achieved are in accordance with the schedule and that what

is described is effectively realized and results suitable to the achievement of the goals.

QUALITY SURVEILLANCE

Check and control of the status of the procedures, methods, conditions, processes,

products and services, examinations of records and certificates in respect to the stated

reference documents, in order to assure the fulfillment of the requirements established

for the quality. This could be implemented by or on behalf of the customer.

QUALITY SYSTEM REVIEW

Formal evaluation by the Top Management, of the status of the quality system and of

its appropriateness, related to the policy for quality and to possible new goals

originated from the variation of the conditions.

TESTING & INSPECTION

Activity of measurement, examination, test, control by means of calipers, for one or

more characteristics of a product or service, in accordance with specified

requirements, in order to check for the relevant conformity.

TRACEABILITY

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Capability to recall the history and follow up the usage or the location of an article or

of an activity (or similar articles and activities), by means of the identification

documented and predisposed.

CONFORMITY

The satisfaction of defined requirements.

NON CONFORMITY

Non-satisfaction of specified requirements.

SUPPLIER

The organization which provides a product to the customer

SUBCONTRACTOR

A Company which supplies products or services through a direct agreement with the

supplier. Sometimes it is called also "sub tier".

PROCESS

A group of resources and activities dependent to each other, that transform input in

output.

OBJECTIVE EVIDENCE

Information that could be proven true on the basis of achieved events by means of

observations, measurements, test and other means.

Regarding all the others general terms and definitions referred to the ISO 9000

applicable version, see Paragraph 2.

Same particular terms used by the organization connected to the specific process are

listed in the pertinent procedures.

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Acronyms:

IHF - IACOBUCCI HF Aerospace

CEO - Managing Director

HQS - Quality Management

AQU - Quality Assurance

CQU - Quality Control & Certifying Staff (CS)

COL - Incoming Inspection

CSP - Customer Support

PZP - Production Planning

PDZ - Product Realization

INP - Production Engineering

MAG - Warehouse & Logistics

COM - Sales Department

AMF - Finance & Administration

ACQ - Purchasing & Planning

IT - Computer Data System & Data File

HR - Human Resources

S&H - Safety and Health

MOA - EASA part 145 Maintenance Organization Approval

POA - EASA part 21 Production Organization Approval

APtoDOA - EASA part 21 Alternative Procedure to Design Organization Approval

MKG - Marketing

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4. QUALITY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS

IHF has predisposed and documented a Quality Management System complying to the

Norms in paragraph 2.

Such System is kept up-to-dated and improved with regard to its effectiveness.

The Quality Management System has been structured by processes.

In particular the Organization has identified the relevant processes needed for the

Quality Management System (See Paragraph IV) and with regard to them has:

1. defined the sequence of the processes (See Paragraph IV);

2. established the criterions and methods needed to assure an effectively and

efficiently control of the processes;

3. ensured the availability of the resources and of the needed information necessary to

support the implementation and monitoring of the processes;

4. defined the method to monitor, measure (if applicable) and analyze the processes;

5. implemented actions necessary to achieve planned results and continuous

improvement of the processes.

Regarding outsourced processes, affecting product conformity to requirements, IHF

specifies methods of execution and control within the contractual documents, and

verifies their effectiveness by mean of the suppliers monitoring process.

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4.2 DOCUMENTATION REQUIREMENT

4.2.1 GENERAL

The documentation of the Quality Management System is composed of the following

levels:

Lev. Document Code Title Format Purpose and Content

Section 1 QM V QUALITY MANUAL

SINGLE

DOCUMENT

Describes the Quality System in accordance with the quality policy and norms in § 2

Section 2

21-QP()()()

21-OP()()()

21-ADP()()()

9100-QP()()()

QUALITY SYSTEM

PROCEDURES

PROCEDURES COLLECTION

Describe processes necessary to manage the quality system implementation

Section 3 21-IO()()()

QUALITY SYSTEM

OPERATIVE INSTRUCTION

S

PROCEDURE INSTRUCTIONS COLLECTION

They rule some particular activities/processes called out by the reference Procedures

21-MO()()()-()()

9100-MO()()()-()() FORMS

FORM AND RECORD OF THE QUALITY SYSTEM

Forms and records that give the evidence of the level achieved by the implementation of the Quality System.

The documents issued are distributed to the IHF Personnel, Customers and Regulatory

Authorities with the following criteria:

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Lev. Document Code. Title Department & Personnel

Section 1

QM V QUALITY MANUAL

Management (Heads of Departments),

Customers, CRB and/or Certification Authorities

Section 2

21-QP()()()

21-OP()()()

21-ADP()()()

9100-QP()()()

QUALITY SYSTEM

PROCEDURES To the complete Company’s Organization

Section 3

21-IO()()()

QUALITY SYSTEM

OPERATIVE

INSTRUCTIONS

All the interested Departments

21-MO()()()-()() 9100-MO()()()-()() FORMS

As per the processes contained in the Procedures or

Instruction

The following documents are added, if applicable, to the Quality Assurance documents

listed above:

Quality Plan;

Control Quality Plan;

Quality Assurance Forms;

Company Manuals (MOE, POE, APtoDOA Handbook) for aeronautical Airworthiness or

Customers;

Quality Master Plan and Objectives;

A Quality Plan is issued when a specific quality requirement, not covered by the actual

Quality Management System, is invoked by a contractual document; the Quality Plan

is subsidiary to the actual procedures.

The up mentioned documentation for the Quality Management System, is issued by

the Quality Department or, in any case, approved by the HQS.

In addition to the discussed documents the Quality Management System

documentation could be composed by Technical Operative Documentation issued to

execute and to manage a process.

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Quality Department, manages the distribution of all the Quality Assurance

Documentation.

Quality Master Plan and Objectives are documents that allow to assure the effective

control and monitoring of the organization processes according to the Quality Policy.

All the documentation of Quality Management System is reviewed yearly unless when

necessary.

The Quality System Review, may involve the new issue of the whole documents

(Quality Manual, Procedures and Quality Plan) with the new index of revision and a

detailed description of the change in the Revision paragraph.

Quality Manual, if required, can be distributed outside of IHF. In such case, except

specific applications, will be provided a copy of the last index, without any

commitment to supply the future updating documents.

Procedures and Instructions (21-QP()()(), 21-OP()()(), 21-ADP()()(), 9100-QP()()()

and 21-IO()()(), 9100-IO()()()) are distributed only inside the IHF.

Quality Plans, edited by the Quality Management Department, are distributed to

external people having part in a specific project and to the interested inner

Department.

4.2.2 QUALITY MANUAL

The Quality Manual is the document of synthesis used to describe, document,

coordinate and integrate the IHF structure, the responsibilities, and all the activities

regarding the Quality System Management.

The document exposes the following topics:

• the aim and applicability of the Quality Management System.;

• the procedures established for the Quality Management System;

• a synthetic description of the Quality Management System processes and of their

interactions.

The management of the changes for the Quality Manual is realized by the attribution of

a number of issue and a letter of amendment to each page; both of them are used in

sequence and are written, together with the date of the change, in the header of the

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page. The letter of issue increases when a “significant change” occurs in the

Organization. The following types of changes are considered significant:

- changes in the organization structure and/or in the Organization Quality System;

- changes in the Organization scope of work;

- changes affecting the Management Staff, their responsibilities and the

responsibilities among the certified personnel;

- change of resources in terms of number, skill

- change of the facility or relocation of new premises;

- change of ownership;

- changes of Organization name, address or corporate name.

All this changes must be communicated to the Customer if requested by the agreement

signed with them.

Changes not included among the significant ones are considered “minor changes”, they

will increase the number of amendment. The modified text is highlighted by means of

blue color in correspondence of the section/paragraph modified. All the modified

paragraphs are listed in the table “List of revisions” with a brief description of the

reason of change; moreover the list of effective pages will be up-to-dated when new

issues and/or new amendments occur.

4.2.3 CONTROL OF DOCUMENTS

With exception to this manual, IHF issues documented procedures in order to define

methods and responsibilities for managing the Quality System documentation.

The documented procedures assure that:

• documents are approved for adequacy before their issue; when necessary they’re

reviewed, up-to-dated and re-approved before their new issue. The documents are

considered approved when they are signed for Preparation, Verification and

Approval by the designed people. The Designed person characteristics are reported

in the 21-IQ001. The authorized signatories are indicated by means their function

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on the Title Row of the Revision Table in the 21-QP/OP/ADP/IO()()() and 9100-

QP/IO()()() procedures.

• the changes in the documents are identified and the state on the current revision of

the documents recorded. With regard to the 9100-QP/IO()()(), the identification of

the updated procedures parts will be made by means of the Vertical Line in

correspondence of the changed text, for the 21-QP/OP/ADP/IO series the

identification method is reported on the 21-QP001.

• the documents are available in the pertinent version, in the places of use;

• the documents are readable, easily identifiable and traceable;

• the documents of external origin, determined by IHF to be necessary for the

planning and operation of the quality management system, are identified and their

distribution is controlled;

• the obsolete documents are removed from the places of use under the responsibility

of the RdF as reported in the 21-QP001.

Superseded documents retained for any purpose are suitably identified; the document

distribution, the document format, the management of external and obsolete

document is managed as indicated in the 21-QP001.

References:

Procedure: 21-QP001 “Emissione, approvazione e modifica dei documenti”;

Instruction: 21-IQ001-01 “Impostazione e stesura di procedure, istruzioni, modulistica

e manuale”;

4.2.4 CONTROL OF RECORDS

All the Records produced by the IHF and relevant for the QMS are described into the

procedures and called into the Processes shown in paragraph V.

The procedure 21-OP010 “Compilazione e Tenuta delle registrazioni” and, in addition,

the table 21-MQ010-01 ”Matrice dei Documenti del Sistema Qualità”, define the

control adopted by IHF for the identification, storage, protection, retrieval and

disposition of records. The procedure 21-OP010 defines also the method for controlling

records created and retained, as applicable, by the suppliers.

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Reference:

Procedure 21-OP010 “Compilazione e Tenuta delle registrazioni”;

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5. MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT

With reference to the “Top Management Statement”, the Top Management provide

evidence of its commitment to the development and implementation of the Quality

Management System and continually improving its effectiveness by:

a. communicating to the organization about the importance of the customer and

statutory requirements (Laws, Airworthiness Regulations), this can be done by

means of:

quality trends communications;

in-service problem bulletins;

periodical Staff Meetings;

notices on Company board, etc..

b. application of the concepts contained in the IHF Quality Policy;

c. objectives for each Department in line with the IHF Policy;

d. Quality System Review conducted and with the review of the Quality System

Indicators;

e. the assurance of the availability of resources supporting the Quality Objectives

achievement.

5.2 CUSTOMER FOCUS

The Top Management is actively involved in order to assure that the Customer

expectation will be clearly understood, identified, translated into standard

requirements and complied (See Paragraph 7.2.1).

At this scope the product conformity and the on time delivery performance are

measured as indexes to evaluate the customer satisfaction.

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5.3 QUALITY POLICY

IHF policy is based on the “Top Management Statement” reported in the paragraph I,

and ensures that:

the quality Policy is appropriate to the purpose of the IHF, by means of the

Company Mission.

the commitment to comply with required high standard and the continuous

improvement of the Quality Management System effectiveness, is in the Top

Management Statement.

the quality objectives communication is made by means of several media, but

mainly by the Staff Meeting and the meeting report.

the quality policy and the quality objectives are communicated and understood

within the IHF. During the Staff Meeting the quality policy and the objectives are

reviewed and can also be modified for its continuing suitability.

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5.4 PLANNING

Data and Information Analysis

Data Gathering

Improvement Actions Definition and Planning

Possible Improvement Actions Proposal and Indicators Definition

Team Definition

Action Effectivity Evaluation

Data Analysis with Indicators

CEO/ALL

CEO

TEAM

TEAM

CEO

Interested Functions

TEAM

CEO/ALL

Improving Opportunities from Staff Meeting:- Quality System Review;- Communication of new objectives and strategies;- Company Riorganization;- Request and needings by customer and/or suppliers.

Agenda Discussion

Mansion and Responsibilities Assignment

Improvement Action Execution

POA/MOA/APtoDOA

CEO/ALL

CEO/TEAM

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5.4.1 QUALITY OBJECTIVES

Since the Quality Policy has been outlined from Top Management, and supported by

all the Department Managers, the Top Management defines the Quality Master Plan

and Objectives in the year.

The objectives are referenced to organization, technical and operational resources,

resources acquisition, structure and so on. This is to meet the requirements of the

processes necessary for the organization functioning.

The official copy of the Quality Master Plan and Objectives is distributed to the

responsible personnel, to generate the consequent actions for the objectives

achievement. The Quality Master Plan can be documented by means of the Staff

Meeting Reports.

The objectives are formulated considering the measurable characteristics and

expressed by means of proper indexes. The overall assessment regarding the

achieved objectives is carried out into the Quality System Review process as

indicated in the flow chart of support process 6 “System review and continuous

improvement” see § 5.4.

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

The Top Management, through the Quality Assurance Department, ensures that the

planning of the Quality Management System is suitable for the correct identification,

definition, check and improvement of the IHF processes, and for the achievement of

the established Quality Objectives.

In particular, the planning of the Quality Management System includes:

the editing of the Quality Manual, of the Procedures and of the documentation of

the Quality (Operational Instructions, models etc..);

the acquisition and the availability of suitable resources: human, technical and

structural;

the definition of the IHF processes, relating to Management System, and to the

customer, logistic processes, servicing processes, monitoring and improvement.

the management of the documents and of the Quality Records;

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Such activities are developed in the continuous improvement of the System and in

order to increase the satisfaction of the customer.

The Quality Assurance Department assures that the integrity of the Quality

Management System is maintained during the various phases of the system life.

5.5. RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1. RESPONSIBILITY AND AUTHORITY

To guarantee and support an effective Quality Management System, among IHF

personnel, the role of the various functions and their connection in the

Organization, have been defined in a chart, and issued as well as the related

responsibility and authority.

Top Management has issued and approved for the above purpose:

- IHF’s organization chart;

- IHF’s personnel duties.

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Organization Chart – IHF Functions

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Duties and Responsibility

Herein below, duties and responsibilities of the IHF Departments, mentioned in the

organizational chart, having role in the IHF’s Organization.

Managing Director (AM - CEO)

Is responsible to:

a) define and emanate the IHF’s policies and objectives, included those related to the

quality;

b) establish the strategies for the implementation of the aforesaid policies and goals;

c) evaluate and approve the programs implementation proposed by the IHF’s

Organization;

d) evaluate and approve the IHF’s budget proposed by the organization, relating to

the above mentioned programs;

e) verify, review and approve the trend of the IHF Management in reference to the

above mentioned programs and budget, deciding also the priorities;

f) survey the financial administration of the IHF, deciding also the investment and

credit policies;

g) assure the finance for the established plans;

h) manage the relationships of strategic business for the IHF;

i) promote and conduct the review of the Quality System;

j) guarantee, in general, the implementation, the maintenance and improvement of

the IHF’s Quality System, in reference to the established policy and goals of the

Quality.

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General Manager (DGN)

Reports to CEO and is responsible for coordinating the areas of Finance, Operations

and Human Resources to ensure the efficiency of resources for productive activities. In

particular, in the area of operations, in collaboration with the COO he is responsible

for:

- organize activities considering the redistribution of tasks based on the needs of production;

- manages the employees, considering the main factors affecting the activity of production, such as environmental conditions, the performance limit of employees and ergonomics.

In Human Resources, in collaboration with the Human Resources Manager, he is responsible to promote:

- the development of the staff through training campaigns, seminars and internal training;

- the necessary actions to mitigate the risks from the relevant management personnel;

- necessary analysis to identify areas of intervention for the proper management of the manpower.

In Finance, in collaboration with the Head of Administration, it has the responsibility to ensure the proper administrative, accounting and finance, to ensure business continuity (delivery fees, payment of suppliers and other tax issues).

Administration (CFO)

Reports to DGN and is responsible to:

a) plan and implement the IHF’s administrative, accounting, financial and insurance

activities, in accordance with the laws and the assigned directions;

b) manage the cash flow and the coordination of the control activities of the financial;

c) manage the external relationships with the customers, suppliers, administrative

public units, etc. with regard to the cash flow;

d) manage the relationships with the credit Institutes;

e) coordinate with the various Departments, for the definition of the strategies

related to the payment of suppliers and employees, collection of debts, etc…;

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f) cooperate with the various Departments for each change proposal to the

strategies, or highlighting irregularities, relevant to the payments etc.;

g) find out the information and documents on the financing opportunities;

h) interact with the various Departments for the tasks resulting from access

opportunities to the financing channels;

i) coordinate, in collaboration with CEO, for the drawing up of the annual budget;

j) supervise to the implementation of the tax activity in accordance with the terms of

law;

k) control of the survey of the IHF’s costs;

l) manage and organize the IHF’s administrative and fiscal files;

m) manage the fiscal aspects for the warehouses.

Human Resource (HR)

Reports to DGN and is responsible to:

a) develop the Human Resource Policy in accordance to the Company Policy;

b) manage the Human Resources in collaboration with the IHF Departments in terms

of:

research for human resources,

hiring of new personnel,

entry in force of new personnel;

c) collaborate to fix the necessary characteristics/skill level, required in the various

Departments, for the assigned human resources;

d) promote the growing up of the personnel, as per the needing of the organization

by mean of:

training campaigns;

internal seminars;

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dedicate courses;

e) manage the Human Resource assessment for the various Company purposes:

Supporting the Department Responsible in the assessment interviews;

Managing the assessment questionnaires;

issuing assessment personal charts;

recording the evidences;

f) perform the analysis aimed to highlight the critical area of the Organization with

regard to the Human Resources.

g) propose the necessary actions to mitigate the risks with regard to the human

resources.

h) calculate the costs of the human resources, the vacations and the various

competences.

Information Technology (IT)

Report to the CEO and is responsible to:

a) manage the Company network of the ERP system;

b) provide any assistance for the HW and SW installed and related tools within the

Organization;

c) collaborate with the Production Planning in order to set up the ERP system in

accordance to the Production Master Plan;

d) keep the external contacts with the SW Houses providing guidance and services to

upgrade the ERP system;

e) conduct the general support on the evolution of the ERP system;

Marketing

Reports to CEO and is responsible to:

a) plan and put in place the activities aiming to promote the products and business;

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b) coordinate and assist the CEO in choosing the direction of the business;

c) communicate internally the strategy of the company with regard to the Business

objectives;

d) develop a public relationship in order to increase the business channels of the

Organization;

e) take care about the brand and image of the Organization;

f) represent the Organization during the commercial events to look after the brand

presentation.

Sales (COM)

Reports to CEO and is responsible to:

a) coordinate the Sales Review process.

b) manage the resources of the commercial area to fulfill the commercial policy

defined by the Top Management;

c) monitor new directions and demands of the acquired and potential market, in

order to address the decisions about the development of the products and/or

investments;

d) verify and define the specifications and contracts, analyze the forms of credits, and

feasibility of legal, temporal, technical-commercial and certification commitments;

e) follow up the feedback from the operational functions involved in the activities

(making offers, bid, tenders, orders, etc…);

f) interact with the customers about the resolution of particular problems (such as

recovery credit, re-examination of contracts; non-conformance of the contractual

procedures, etc…) and assure the necessary after sale assistance;

g) be responsible for the application inside the Commercial Department of IHF’s

Quality System.

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Head of Design organization (HDO)

Reports to CEO and takes on the responsibility, to the Authority, for the compliance to

the airworthiness requirements regarding the design of all the galley inserts and

interiors. The Design Management is responsible to:

a) optimize and direct the resources operating in the engineering for an effective and

efficient treatment of the activities and tasks assigned;

b) ensures the collaboration with the Commercial Department for the preliminary

technical valuation of tender;

c) ensures the correct and effective interaction between the Design Organization and

external entities such as Agency, customer or suppliers;

d) ensures the correct planning, execution, check and approval of the projects, in

compliance with technical and financial parameters foreseen/expected, as well as

with applicable rules and procedures;

e) ensures the compliance of the technical documentation issued with the customer

basis requirements, with the law requirements and with the airworthiness

requirements, as well as its correct issuing and distribution;

f) ensures the correct and complete course of all the activities connected to the

articles certification, in compliance with the applicable requirements, respecting

the established delivery time, issuing all the necessary and requested technical

documentation, assuring correct and effective relations with the Agency;

g) ensures the respect of all the interested quality procedures and of the assigned

objectives concerning the organization quality policy;

h) promotes and facilitates, having recurs to specialist courses if necessary, the

professional grown of the organizational structure; managing, if necessary, its

certification and qualification.

Chief of Operation Officer (COO)

Reports to DGN and is responsible to:

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a) manage the organizational structure of the Production (PDZ), Logistic (ACQ),

Quality Control (COLL, final and incoming inspection, CS), Production Planning and

all the Departments directly involved in the production processes.

b) assure the effective application of the Production Plans, taking care about the

performance of the Production and related activities in terms of quality level and

respect of lead times;

c) collaborate with the other Departments Responsible in order to have a Production

Processes completely organized following the defined procedures; is also

responsible to take under control the House Keeping of the Production Areas.

d) take in consideration the respect of expected economic parameters;

e) assure the respect of the procedures of the IHF’s Quality System and of the

assigned tasks inside the IHF’s Quality Policies;

f) support the Production Engineering in the developing of its duties with particular

regards to:

a. the applicability of the issued manufacturing data;

b. the technical analysis for the non-conformities issues for the product;

c. test and inspection on parts to optimize the products;

g) promote and facilitate, even applying to dedicate courses, the professional growth

of its own structure;

h) motivate the collaborators for achieve the assigned tasks in the respect of the IHF’s

directions.

Production Engineering (INP)

Reports to COO and is responsible to:

a) assure the continued airworthiness of the product through the complete

implementation of the Design Data with an adequate configuration control;

b) act as adequate link between the Design Organization and the Production

Departments in order to solve all the issues related to the Configuration

Management of the product and to product evolution;

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c) assure the necessary support to the Design Organization during the design of new

product;

d) cooperate with the Design Organization to improve the product by proposing

solutions based on technical investigation;

e) assure the fully compliance of the issued Manufacturing Data with the ultimate

revision of the Design Data;

f) analyze the production process in terms of tools, timing and equipment; and is

responsible to manage and issue the relative data;

g) assure the best industrialization of the manufacturing processes;

h) monitor the production processes;

i) support the supply chain with adequate Manufacturing Data in order to cascade the

design requirements to the suppliers;

j) assure the availability of the Manufacturing Data in due time according to the

Production Plan;

k) analyze and solve production deviations and non-conforming parts;

l) collect any information and any consequent investigation related to occurrences

that may involve failures, defects and malfunctions in any products, part or

appliance related to the Design Data;

m) collaborate in the Subcontractors an Suppliers technical assessment process;

n) collaborate in the Sales and Contract review process;

o) collaborate with the Production Department to solve the traceability issues of the

parts;

p) collaborate with the Production Department and with the Quality Department in

case of Customer Claim or claimed “In service Problem“, included the case of

Occurrence Reports involving the Authorities.

Quality Management (HQS)

The Quality Manager, reports to CEO and is responsible to:

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a) ensure the compliance of the Quality Management System to the requirements of

the applicable standards (i.e.: AS/EN9100);

b) assure the implementation of the Quality System, in conformity with the approved

quality documentations;

c) supervise the implementation of the Quality Policy established by CEO;

d) implement and promote the audit activity (system and process) through internal

audits and external audits at the sub-suppliers;

e) assure the qualification of the personnel involved in activities of control, audit and

Quality certification (such as inspectors, auditors and certifying staff);

f) take care as far as its own competence is concerned, the relationship with the

Authorities, CRB and customer Quality representatives;

g) effectively and efficiently manage the assigned resources to supervise the assigned

Department tasks in the respect of Regulations, Company’s Procedures and Laws .

(For details see the paragraph 5.5.2.)

Maintenance Management (MOA)

The Maintenance Products Department is managed by the Maintenance Manager who

refers to CEO.

The Maintenance Manager has the responsibility to assure that all the maintenance

activities are carried out in accordance with EASA part-145 and particularly in

accordance with the IHF’s MOE (Maintenance Organization Exposition).

Procurement (ACQ)

Reports to COO and to the Production Manager (for purchased materials relates to the

Production) and is responsible to:

a) carry out all formalities in order to commence the relationship with potential

Suppliers and Subcontractors;

b) stipulate contracts and bilateral agreements with Suppliers/Subcontractors;

c) list and classify Supplier and Subcontractors of the Company Supply Chain;

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d) process the approve purchaser requests and issue the Purchase Orders;

e) manage suppliers with regard to the purchase orders already issued;

f) collect and internally deliver the Supplier inquiries for technical clarification

concerning the subcontracted parts;

g) act as link between the Suppliers and the Quality Control to give solutions for the

non-conformities of purchased products;

h) support the Quality Assurance Department in the supplier qualification process;

i) perform the scouting process in order to find external sources to subcontract the

parts.

Safety and Health System (S&H)

Report to the CEO and is responsible to:

a) coordinate any action related to the control of environmental factors affecting the

normal production processes (such as temperature, humidity, lightning, cleanliness,

protection from electrostatic discharge, etc.);

b) assure the improvement, conformance and/or efficient maintenance of the factory’s

assets (such as buildings, equipment, machines and tooling) in accordance with the

current laws of hygiene and industrial safety;

c) assure the respect of the established House Keeping in order to control the FOD

occurrence for the Products delivered;

d) take care about the Maintenance Programs of the equipments in accordance to the

Production Processes;

e) process, promote, develop and apply the new factory lay-out in accordance with the

Production Processes evolution and in agreement with the Company Budget.

5.5.2 MANAGEMENT REPRESENTATIVE

The Quality Manager, is the designate “Management Representative”, as per the

previous paragraph, he has the organizational freedom and unrestricted access to Top

Management to resolve quality management issues reporting directly to the CEO; in

addition to the tasks already listed, he is responsible to:

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analyze and assess the performances of the Quality Management System and every

other demand of improvement;

plan the audit system and communicate with the Authorities regarding possible

problems connected to the Quality and Airworthiness.

implement the internal Audit plan to verify the correct actuation and effectiveness

of the Quality System;

schedule the dates of the periodical Audit;

monitor the corrective and preventive actions, taking care to verify the

effectiveness in order to promote the continuing improvement of the Quality

System;

catch the opportunity to improve the IHF’s Quality System;

interconnect to all Departments to furnish the necessary support on the Quality

aspect, assuring the real application of established methodologies.

The Quality Manager has the Authority to put in place monitoring systems, audit and

corrective/preventive actions to conform the Quality Management System to the

Quality Manual and its relative requirements.

Moreover he maintains a proper liaison with external parties for the topics concerning

the QMS.

5.5.3 INTERNAL COMMUNICATION

IHF has founded and activated an effective communication system between the

various Departments to manage the processes of the Quality Management System and

their effectiveness.

With reference to this scope, the Top Management has defined the flows, interfaces,

and prescriptive measures to guarantee a suitable knowledge, comprehension and

implementation of the Quality Management System and a constant feedback on its

effectiveness (quality training, meetings, etc..).

Moreover in order to setup an effective communication among the various Department

Representatives, periodical Staff Meetings are scheduled.

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The Staff Meetings can be considered an opportunity to evaluate the effective

application of the Organization Policy and its eventual adjustment, the strategic

objectives originating by those adjustments and can also include separated analysis

for ordinary Programs, looking after Consolidated Products/Programs, and new

Projects/Programs regarding new Products or new Customer Programs.

For every Staff Meeting a Minute is issued and recorded (Mod. 9100-MO002) by the

Department whom has called the Meeting.

5.6. MANAGEMENT REVIEW

5.6.1 GENERAL

The IHF’s Quality Management System is yearly reviewed by the Top Management, or

whenever it is necessary.

The Management Review is the practical control of the efficiency status of the

organization, with the purpose to improve the Company Quality Management System.

The CEO with the support of all the Managers carries out the review.

The Management Review can include assessment of improvement opportunities and

need for changes of the Quality Management System, including Quality Policy and

Quality Objectives.

The Management Review, is one of the fundamental elements constituting the Annual

Improvement Plan (or Quality Master Plan and Objectives) and the associated records

are maintained by the Quality Assurance Department.

5.6.2 REVIEW INPUT

To carry out the review, the Top Management, according to Quality Manager and the

Function Responsible, analyses the following parameters:

• audit results (Internal/External);

• claims or feedback from the Customers;

• control indexes from the Product/Process;

• corrective and Preventive actions reports;

• input from Staff Meetings;

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• objectives control indexes;

• new Quality requirements.

5.6.3 REVIEW OUTPUT

The Top Management, afterwards the review, plans the actions related to:

• issue the guide lines for the improvement of the effectiveness of the Quality

Management System and of the associated processes;

• upgrade, improve and fit IHF’s products with regard to the customer expectations

and to the customer requirements;

• decide the Resources Plan/Budget.

The review of the results, the examined documents, the corrective actions and

dispositions to proceed and the actions to be undertaken are formalized on the

“Quality System Review”, undersigned by all the participants, approved by the CEO,

and retained c/o the Quality Department.

All the Departments involved in the management of the Quality System, can propose

to the Quality Manager possible changes or modifications involving the Quality

System, always in accordance with the Company’s objectives.

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6. RESOURCE MANAGEMENT

6.1. PROVISION OF RESOURCES

IHF has provided needfull resources in terms of personnel, equipments and

instruments, to implement and maintain the Quality Management System.

In particular to:

a) fulfill the processes related to the product and to the Quality Management System,

in order to prevent possible non-conformities and/or implement the improvements.

b) fulfill the planned quality audits in all the Company’s areas to verify the

Organization activities with regard to the Quality Management System Procedures.

c) meet the customer expectations regarding supplied services and/or products;

moreover to enhance customer satisfaction by meeting its requirements.

6.2 HUMAN RESOURCES

6.2.1 GENERAL

Personnel involved in the activities affecting the quality of the product have an

adequate level of competence, assured by the combination of several elements,

required in consideration of the characteristics, the role and the responsibilities

assigned.

The factors concurring to the required level of competence are:

adequate educational level;

work experience;

specific training received;

owned skills.

The following figures inside the Organization are selected and qualified on the basis of

the previous elements:

Quality Control Inspectors;

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Auditors;

Responsible of Operative Area;

Responsible of Department.

6.2.2 COMPETENCE, TRAINING AND AWARENESS

All the personnel is responsible for its own activities and, takes part to the

improvement and development of the Quality Management System and to the

achievement of the Quality Objectives.

Performed actions, issued procedures and assigned responsibilities have the aim of:

define the necessary level of competence for personnel performing work affecting

quality aspects;

define the gap for each person between the necessary level and his/her own level;

provide training or take other actions to achieve the necessary level;

evaluate the effectiveness of training given;

ensure the awareness of everyone regarding the relevance and the importance of

his/hers activities in the achievement of the Quality Objectives.

The records concerning the “significant data” are adequately preserved and filed in

order to monitor the qualification level achieved.

The education program can include training meetings, internal and/or external courses

or training on the job; it’s personalized for each duty, considering the following three

guidelines:

1. all the personnel must be familiar with the aspects relating to the established

Quality System and its relevant procedures;

2. generally, all the personnel must receive a specific technical and/or managerial

training, connected to the technical-productive processes in which he/her is

involved;

3. a specific formative training is necessary for Quality Inspectors, Auditors and

Certifying Staff.

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The aim of the education is the refreshing of the personnel competence with regard to

the quality aspects; the success of the up mentioned activities, is considered strategic

for IHF.

The technical/production refresh courses are finalized to the qualification and

improvement of the personnel’s skill, oriented to theoretical-practical aspects related

to technologies, machines and production processes.

Personnel that carry on the quality control and audit activities, such as Inspectors,

Auditors and Certifying Staff, are qualified by means of specific training.

This qualification, is assured through the verification of appropriate individual

characteristic, by the Quality Manager, moreover an initial training (i.e. Courses,

training on the job, etc…) is carried out to allow the achievement of the necessary

requisites.

IHF periodically asses the skill level of all the personnel involved in the Quality System

Management.

The Quality Procedure 21-QP011 “Competenza e Qualificazione del Personale” regards

the know-how and qualification of personnel affecting the Quality aspect of the IHF

products.

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6.3 INFRASTRUCTURE Intervention

Request

New Intervention?

Work Planning

Feasible?

Work Coordination

CEO Approval?

Validation

Validation OK?

Utilization

Maintenance Request

Validation

Work Planning

Ordinary intervention?

Intervention Plans

Technical Requirements Defect Analysis

Technical / Economical Analysis

Feasible?

End of Process Validation OK?

NO

NO

YES

YES

YES

YES

NO

NO

NO

NO

NO

YES

YES

YES

POA/MOA/APtoDOA

ACQ

S&H/IT

POA/MOA/APtoDOA

ACQ

S&H/IT

POA/MOA/APtoDOA

S&H/IT

POA/MOA/APtoDOA

POA/MOA/APtoDOA

INP

S&H/IT

POA/MOA/APtoDOA

S&H/IT

POA/MOA/APtoDOA

S&H/IT

INP/S&H/IT

Purchase Request

Purchase Order

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Efficient plant, machinery and equipments are fundamental requirements in order to

carry out the activities and to achieve the conformity to the product requirements; for

these reasons and to prevent non-conformities, The IHF defines and performs the

maintenance activities of the infrastructures involved in the processes.

All the machinery and the equipments are approved before their use in the production

processes; with respect of their features, they’re checked and maintained to

guarantee their functionality, accuracy and safety.

The evidence is given by appropriate lists, showing, for each item, the following

information:

the kind of maintenance that must be performed, it can be Preventive

Maintenance (P.M.) or Corrective Maintenance (C.M.);

the personnel involved in the maintenance activities (inner resources or specialized

technicians in outsourcing);

the Department having in charge the machinery/equipment.

In addition other specifications related to the particular equipment can be listed.

Preventive Maintenance

The Preventive Maintenance aim to prevent the possible malfunction of all the

production equipments and machineries. It must be applied according to the

specifications and to the service operations, reported on the owner manual of the

equipment/machinery.

The Preventive Maintenance activities are scheduled by mean of a specific plan issued

for each machinery or equipment.

These defined activities implement the following aspects:

Economical - minimal economical impact for the maintenance costs;

Technical - technical feasibility of the maintenance operation;

Operational - acceptable impact on the production schedule;

Safety - regarding the safety requirements that must be met;

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Corrective Maintenance

The Corrective Maintenance is made on demand and it aims to repair a failure or an

inefficiency occurred in the production line. It can also consist in a further action,

required as result of a preventive maintenance operation, when a potential failure

condition for the equipment has been highlighted.

For both kind of maintenance operations, the Responsible of the Safety and Health

(S&H) Department planes and coordinates the activities; in case of Corrective

Maintenance he will schedule the maintenance operation in order to minimize the

production plan discomfort, however the machine stop must be approved by the

Production Responsible.

Moreover the S&H Department will be supported by outsourcing Technical Assistance,

with preventive approval of the Production Department, or by internal Departments

chosen on the basis of the specific necessary action.

All the maintenance activities are carried out in observance of the industrial safety and

health requirements.

6.4 WORK ENVIRONMENT

The environmental, human and physical factors are identified and properly managed

to realize the conformity of the products.

The factors affecting the conformity of the product like FOD (Foreign Object Debris) or

other are controlled by the Responsible of each area.

Regular notices are issued in order to make aware the working personnel about the

needing to take under control the cleanness and the FOD condition of the area.

A special team is dedicated to assess and establish the Work Environmental Factors; it

is composed of:

the Production Representative;

the H&S Representative;

the Quality Representative;

a representative of the specific area under observation.

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The typical assessed factors are:

temperature and humidity;

lighting;

cleanness;

house keeping;

ergonomics;

material protection;

equipment level.

IHF assures and guarantees that its personnel meet the requirements of the safety

regulations and guarantees the prevention of any risk in the working environment in

conformity with the Laws in force.

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7. PRODUCT REALIZATION

Hystoric P/N?

Production Plan

Warehouse taking

Warehouse depository

Incoming Check

Purchasing Process

Material Compliant?

Final Check

Final Assembly

Intermediate check

Assembly lines

Subassy compliant?

P/N compliant?

Warehouse depository

Packaging

Packaging check

Packaging compliant?

Packaging Check

Shipment

Design ProcessAs per 21-ADP001

Purchasing Process

Production Plan

Manufacturing data release

Approved Design data reception

Preliminary Release Manufacturing Data

FAI

Incoming Check

FAI ok?

Assembly lines

Warehouse taking

Warehouse depository

FAI

FAI ok?

Final Assembly

FAI

FAI ok?

N/C Management

N/C Management

CSP

MAG

MAG

COLL

ACQ

INP

INP

INP

CS

PDZ

COLL

PDZ

MAG

MAG

CS

CS

LOG

Design Organization

INP

INP

INP

INP

ACQ

COLL

COLL

MAG

MAG

PDZ

COLL

PDZ

COLL

INP

NO

NO

NO

NO

NO

YES

NO

NO

YES

YES

YES

YES

YES

YES

YES

NO

Work Order / PO

Approved Manufacturing Data

Approved Manufacturing Data

Order Reception and Review

Order in compliance

with the offer?

Offer / order Disagreement Solution

Order compliant to

the offer?Order insertion in

Master Plan

YES

NO

YES

NO

COMM

COMM

Customer communication

CSP

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KEY PROCESS 2 PRODUCT REALIZATION

Customer Order;Risk Analysis;Approved Design Data;Manufacturing Data;

Product realization in compliance to approved design data.

POE;21-MO007-02 (Schede strumenti);21-MQ009-01 Agreement DOA/POA Form;Master Plan;Capability List;FAI;21-MO005-06 (ECN Form);Quality Assurance Audit.

Purchased Materials;Assembly Lines;Measurement Instruments;Warehouse;ERP System.

ENGINEERING FOR PRODUCTION PRODUCTION PLANNING PRODUCTION PURCHASING DEPARTMENT INVOLVED FUNCTIONS:

Inspection;Customer SupportAPtoDOA

Nr of planned units / produced units;Lacks Classification;Product Non Conformance;On Time Delivery.

Process Needing Resources

Process Responsibilities

Process Monitoring

Process efficiency measurement

HOW? RESULTS (KPI)?

WHAT? WHO?

INPUT OUTPUT

7.1 PLANNING OF PRODUCT REALIZATION

IHF has defined the procedures for planning the production processes in conformity to

the norms listed in paragraph 2 and consistently with the requirements of the other

processes of the quality management system.

The planning is realized:

according to quality objectives and requirements for the product, including:

- product and personal safety;

- reliability, availability, and maintainability of the product;

- producibility and inspectability of the product;

- suitability of parts and material used in the product;

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- selection of embedded software when necessary;

- recycling and/or final disposal of the product at the end of its life.

according to all the requirements of the Quality Management System and the

applicable aeronautical rules;

defining processes and documents and providing resources specific for the product;

ensuring a configuration management appropriate to the product;

with evaluation of necessary resources to support the use and the maintenance of

the product.

All the activities regarding required verification, validation, monitoring, measurements,

inspection and test, specific for the product and the criteria for its acceptance are also

considered, together with the records needed to provide evidence of the product

conformity to the requirements.

For these purposes, the IHF, by means of defined procedures, has described and

documented the flow of activities, the operational phases, the criteria and the

responsibilities connected to the product realization and its inspection; assuring that

such activities are completed respecting the delivery date and performing the

necessary inspections at all stages of the product realization.

All the characteristics of the product realization process are summarized in the flow

chart and in the turtle diagram at the top of this chapter and detailed in the procedure

21-OP005 “Processi di Produzione” see also § 7.5.1.

Referenece:

Procedure 21-OP005 “Processi di Produzione”;

Procedure 21-OP009 “Coordinamento ai fini dell’aeronavigabilità”;

Procedure 21-ADP001 “Design data management”

Procedure 21-ADP005 “Assistenza Tecnica e pubblicazioni tecniche”.

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7.1.1 PROJECT MANAGEMENT

IHF has defined the procedures for planning and managing the product realization to

meet requirements at acceptable risk, within resource constrains and schedule

constrains.

The product realization is planned, scheduled and controlled in collaboration with all

the involved Department Responsible; responsibilities are defined for managing

activities in case of leaking of resources or in case of troubles for maintaining

scheduled constrains.

Referenece:

Procedure 21-OP005 “Processi di Produzione”;

Procedure 9100-QP016 “Gestione vendite”.

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7.1.2 RISK MANAGEMENT

Offer request

Risk management Team definition

Acceptable?NO

Definition of Gravity levels and associated risk values

Definition of Probability levels and associated risk values

Definition of Detectability levels and associated risk values

Criticity Index achievement

Criticity Index acceptability level

Mitigation Risk Execution Activities

Mitigation Risk Planning Activities

Mitigation Risk Monitoring Activities

Activities Effective?

YES

NO

YES

Control Risk Activities End

COMM/HDO/INP

COMM/HDO/INP

COMM/HDO/INP

COMM/HDO/INP

COMM/HDO/INP

COMM/HDO/INP/HQS

COMM/HDO/INP/HQS

COMM/HDO/INP/HQS

CEO

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SUPPORT PROCESS 1 RISK ANALYSIS

Offer request;Risk mitigation activity

Control of risk;

Quality Manual QMV;Evaluation method of Criticity Index;Risk mitigation activity planning.

Customer reliability.Master plan;Production capacity.Personnel competency;

CEO COMM INVOLVED FUNCTIONS:

HDO;INP;RAQ.

Criticity Index

Process Needing Resources Process

Responsibilities

Process Monitoring

Process efficiency measurement

HOW?RESULTS

(KPI)?

WHAT? WHO?

INPUT OUTPUT

IHF has established and implemented a process for the risks management to the

achievement of expected requirements throughout product realization. The

responsibilities for the risk management have been assigned by the identification of a

specific Team, and a criteria has been defined for the evaluation of the risk by means

of a criticality index. Depending on its numerical value, the planned risk mitigating

activities will be executed until its effectiveness makes the risk acceptable.

All the characteristics of the Risk Management process are summarized in the flow

chart and in the turtle diagram at the top of this chapter and detailed in the procedure

9100-QP016 “Gestione vendite”.

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7.1.3 CONFIGURATION MANAGEMENT

Change Request

ECN

ECN to APtoDOA

Approved Design Data

Manufacturing Data Elaboration

FAI necessary?

FAI Execution

FAIR

FAI OK?

Approved Manufacturing Data Release

NO

YES

NO

SI

INP

INP

Design Organization

INP

INP/PDZ/COLL

INP

INP

ALL

Design Change Management Process as per 21-ADP002

Design Organization

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SUPPORT PROCESS 2CONFIGURATION

MANAGEMENTDesign change proposal.

Changes Approval from:- DOH (for NOT ETSO article);- EASA for a MAJOR change to ETSO article;- IHFE APtoDOA for minor changes to ETSO article.

Approved Design Data

ECN;21-ADP002 (Design Change Management);FAI/FAIR.

CAD/CAM software;Test Laboratory;Personnel Skill;Measurement / Test Tools

INP APtoDOA INVOLVED FUNCTIONS:

PDZ;COLL.

Nr of approved ECN’s / Nr of issued ECN’s;Average time for closing FAI.

Process Needing Resources Process

Responsibilities

Process Monitoring

Process efficiency measurement

HOW?RESULTS

(KPI)?

WHAT? WHO?

INPUT OUTPUT

IHF has established and implemented a process for the management of the

configuration in terms of configuration identification and control of changes.

The Product Configuration is identified by a P/N assignment and defined by technical

documents related to the P/N.

The P/N assignment is done in accordance with the criteria that describes the main

characteristic of the product (I.e.: certifications, functional, aesthetic).

The basic document describing the configuration of the original Product are:

Components Drawings;

Top Assembly Drawings;

Schematic Diagram;

Other documents added to describe the Original Configuration are:

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Bill of Material (First level)

The introduction of product changes are identified by the configuration status; it is

shown by means of numeric and literal revisions on the Product identification tag and

its correlated documents.

Changes in the configuration, occurring after the Certification and release of the

Original Configuration Approved data, are managed as described in the Procedure 21-

ADP002 “Design change management” starting from an ECN (Engineering Change

Notice, Form 21-MO005-06).

Reference:

Procedure 21-ADP002 “Design change management”

Procedure 21-ADP004 “Design office data standards”

Procedure 21-OP004 “Identificazione e rintracciabilità”

Procedure 21-OP005 “Processi di Produzione”

7.1.4 CONTROL OF WORK TRANSFERS

IHF plans and controls the temporary or permanent transfer of work only in the case

of transfer from a supplier to another; this process is managed as a supplier changing.

It involves the research and the qualification of a new supplier as per Procedure 21-

OP002 “Qualificazione, Auditing e controllo Fornitori”; Procedure 21-ADP006 “Qualifica

e controllo dei subfornitori” and Flow Chart Support Process 4 “Qualificazione Fornitori”

in pharagraph 7.4.

Reference:

Procedure 21-OP002 “Qualificazione, Auditing e controllo Fornitori”

Procedure 21-ADP006 “Qualifica e controllo dei subfornitori”

Flow Chart Support Process 4 – “Qualifica dei Fornitori”

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7.2 CUSTOMER RELATED PROCESSES

Offer request reception

Compatible?

Time Analysis –Compatibility Master Plan

NO

YES

COMM

COMM Approval?

HQS Approval?

Consolidated configuration

P/N?

Offer issuing

Offer preparing

CEO Approval?

Customer Comunication

Productive Feasibility

Manufacturing Feasibility

Project Feasibility

Resources available for the project?

Technologies available?

Production planning

compatible?

Analysis and Strategies

NO

NO

NO

YES

YES

YES

NO

YES

NO

YES

YES

NO

CSP

COMM

COMM

CSP

Design Organization

INP

PDZ/INP

NO

YES

Risk ManagementCOMM/HDO/

INP/HQS

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KEY PROCESS 1 SALES MANAGEMENT

Customer Requirements;Rules and Norms Requirements.

Offer Issuing according to Norms / Customer requirements

Capability List;9100-QPxx Risk Management;21-MO005-01 Sale’s Order Form;Master Plan;

ERP System;Commercial Network;Production Planning.

SALES OFFICE CUSTOMER SUPPORT INVOLVED FUNCTION:

CEO;Engineering for ProductionProduction Planning;Quality Assurance;Finance and Administration;APtoDOA di IHFE (1).

On Time Delivery

Process Needing Resources

Process Responsibilities

Process Monitoring

Process efficiency measurement

HOW?RESULTS

(KPI)?

WHAT? WHO?

INPUT OUTPUT

(1) Only for new P/N

7.2.1 DETERMINATION OF REQUIREMENT RELATED TO PRODUCT

To assure that all the Customer requirements and expectations are constantly

respected, the IHF pays particular attention in the determination and the achievement

of the requirements related to the product. In detail the requirements taken in

consideration are the following:

requirements specified by the customer, including the ones for delivery and the

ones connected to post-delivery activities;

requirements not stated by the customer but necessary for specified use of the

product;

the statutory and regulatory requirements applicable to the product;

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any other requirements considered necessary by the organization.

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

When the requirements are known, these are reviewed by the IHF before the issue of

a tender, or before taking any commitment with the customer.

This is to evaluate and avoid all kind of risks connected to the specific product and its

production arrangement. The requirements review assures that:

the requirements definition is sufficiently clear and detailed;

the possible differences are solved among the contract requirements or are ordered

with reference to the amendments issued during the offer/quotation;

IHF has the ability to meet the defined requirements;

eventual special requirements of the product are clearly determined;

the risk management process is activated.

The Review is conducted as per procedures 21-OP005 “Processi di Produzione”, 21-

QP016 “Gestione vendite” and included in the Flow Chart, regarding the Key Process 1

“Gestione Vendite”. Where product requirements changes, IHF ensures that all the

relevant documentation are amended and that involved personnel is made aware of

the changes.

Reference :

Procedure 21-OP005 “Processi di Produzione”

Procedure 21-QP016 “Gestione vendite”

Flow Chart Key Process 1- “Gestione Vendite”

7.2.3 CUSTOMER COMMUNICATION

The communications between the IHF and Customers are established in various ways

according to the type of information originated by IHF Departments or Customer.

The flow chart of the Key Process 1 “Gestione Vendite” describes the communication

link from and to the customer along the Process.

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Product information and requirements relating to the contract, including amendments,

are managed and issued by the Commercial Department (COM) and Customer Support

Department (CSP) as per the above mentioned flow chart.

Approved product information, including the Customer claims management, are filed,

distributed internally or externally, by Customer Support Department (CSP) and

managed as per Flow Chart Key Process 3 “Gestione Post-Vendita”.

Flow Chart Key Process 1- “Gestione vendite”

Flow Chart Key Process 3- “Gestione Post-Vendita”

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7.3 DESIGN AND DEVELOPMENT

Sales Order

Master Plan

Initial Technical Coordination Meeting

Design Program

Design Review

Are Design Requirements

satisfied?

Corrective Actions

Preliminary Project Release (Test Article)

Article Qualification as per 21-ADP003

Test Campaign Passed?

Design Changen as per 21-ADP002

Project Release

Y

N

Y

N

Customer/COMM

COMM/CSP

Design Organization Customer and Involved

Organization Dept

PGM/CDO/DOA

Design Organization(PGM/CDO/COA)

PGM

Design Organization(OdA – Design Office)

OoA

PGM

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KEY PROCESS 4 DESIGN PROCESS

New product design;Changes to a consolidated P/N.

Changes Approval from:- DOH (for NOT ETSO article);- EASA for a MAJOR change to ETSO article;- IHFE APtoDOA for minor changes to ETSO article;

Design Data Approval from: - EASA for article ETSO;- DOH for NOT ETSO article.

APtoDOA HandbookAPtoDOA Procedures ;ECN;Airworthiness Directive.

ERP System;CAD/CAM software;Test Laboratory;Personnel Skill.

APtoDOA INVONVELD FUNCTIONS:

Design Office;Office of Airworthiness;Technical Publications;Engineering For Production;Production (Test Article Manufacturing)

Nr of changes (major/minor) to design;Nr of deviation to Master Plan Date.

Process Needing Resources Process

Responsibilities

Process Monitoring

Process Efficiency

Measurement

HOW?RESULTS

(KPI)?

WHAT? WHO?

INPUT OUTPUT

The IHF APtoDOA Organization assures that Planning, Control, Review, and Validation

of the projects are performed in accordance with the assigned objectives (i.e.: Project

execution and optimization, matching the economical, technical, qualitative,

functionally, requirements, etc.) and to guarantee the compliance to the airworthiness

requirements of the projected products.

The activities of a product development and product design are carried out as per the

flow chart at the top of the paragraph.

7.3.1 DESIGN AND DEVELOPMENT PLANNING

Design process will be starting by signature of contract with the customer.

In the contract will be specified all the product requirements.

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Project Manager organizes in collaboration with Head of Design Organization the ITCM

(Initial Technical Coordination Meeting) with the participation of customer

representative and all the resources involved in the program, in order to freeze the

product requirements.

The MoM of the ITCM highlights the following aspects:

- product requirements in terms of certification basis;

- the program milestone;

- Statement of Work;

- Availability of resources;

When the resources have been defined, design development process can start.

The development of design program will be constantly checked both internally and

with the customer according to the basis of program milestone.

The project review has the purpose to guarantee the respect of product requirements

and finally to permit the test article manufacturing accordingly.

In case of design change an Engineering Change Notice (ECN) will be issued.

Through this document is possible to identify the type of change (major or minor) and

its applicability.

All the process and involved departments are specified by Quality System Procedure

21-ADP001 Design Data Management.

7.3.2 DESIGN AND DEVELOPMENT INPUTS

Design Process input data are:

- drawings/specifications from the Aircraft builder/Customer;

- similar projects;

- technical/aesthetic requirements agreed with the Customer (Minute of

meetings; Contract, etc.)

- Airworthiness/certification/qualification requirements.

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The Customer/OEM input are generally reported on the Minute of Initial Meeting (i.e.

Initial Technical Coordination Meeting). The Regulatory Airworthiness input are found

on the reference Norms by means of the Certification Basis and/or on the Certification

Specification of the OEM. The Statement of Work (SoW) is listing and summarizing all

the above Technical Inputs. The Statement of Work is prepared by assigned project

Manager and is approved by the Head of Design Organization. The Project Manager is

responsible to maintain updated the SoW.

The Head of Design Organization, in collaboration with the Chief of Design Office, the

Chief of Office of Airworthiness, will transfer the information from the milestone to the

detailed plans for each Department.

7.3.3 DESIGN AND DEVELOPMENT OUTPUTS

The Output of the Design and Development Process must be in compliance with the

requirements fixed in the initial phases and approved prior their release.

- the results of the design activity consist of:

- approved drawings (i.e. Top Assembly DWGs, Schematic DWGs, Wiring DWGs,

etc.);

- Component Maintenance Manual and Illustrated Part List;

- evidence of approval (i.e ETSO for “ETSO Article” and “Approval for Installation”

for no ETSO Article).

These design output, therefore, represent the inputs for the Production Engineering

activities (Manufacturing Data release), in accordance with the applicable

Airworthiness regulations.

7.3.4 DESIGN AND DEVELOPMENT REVIEW

Design review are performed accordingly to the project milestone. Review mainly

consists in the evaluation of:

- design features that have to meet the basic data and requirements;

- design project developments,

- design project data and test results.

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The design review is necessary in order to check the status of project and step by step

the compliance to the applicable requirements (fixed by Customer and Authority) to

let the progression to next stage by means of minute of meeting.

Participants in such reviews shall include representatives of involved Departments

concerned with the design development phase being reviewed. Record of result of the

reviews and any necessary actions are maintained.

7.3.5 DESIGN AND DEVELOPMENT VERIFICATION

IHF perform Design Controls as per agreed milestone in order to ensure that all the

activities and related outputs have meet the input requirements; evidences are given

by the design documents (ex. drawings, specifications, calculations, etc.) and

certification / qualification Test Report (i.e. structural test, flammability test, electrical

test, environmental test, functional test carried out as per the test-plan and in

compliance to the procedure).

7.3.6 DESIGN AND DEVELOPMENT VALIDATION

Design Data validation is performed in order to ensure that the Production

Organization is capable to meet the Design Organization requirements.

The validation is performed prior the production start by Production Organization

department (Production Engineering, Production and Quality Control), in collaboration

with Design Office. Evidence of those activities are recorded on First Article Inspection

Report.

All the process and involved departments are specified by Quality System Procedure

21-QP006 Inspection and Check.

7.3.6.1 DESIGN AND DEVELOPMENT VERIFICATION AND VALIDATION TESTING

In case of new article, test activities are planned, controlled, performed, reviewed and

documented by Office of Airworthiness.

Chief of Office of Airworthiness (COA) ensures that:

- Test Plan identifies the article being tested, resources used, condition and objective

of test, parameters to be recorded and acceptance criteria;

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- Test procedure describes the methods of operation, the performance of test and

record of result;

- the correct configuration of test article;

- the observation of Test Plan, test procedure and acceptance criteria.

All the process and involved departments are specified by Quality System Procedure

21-ADP003 Management of Certification activities.

7.3.6.2 DESIGN AND DEVELOPMENT VERIFICATION AND VALIDATION

DOCUMENTATION

At completion of design and/or development, COA ensures that reports, calculations,

test results , etc demonstrate that the article definition meets the specification

requirements for all identified operational conditions.

All the process and involved departments are specified by Quality System Procedure

21-ADP003 Management of Certification activities.

7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

All the design changes are managed by issuing of Engineering Change Notice through

the form 21-MO005-01, it represents the document used for request the change

implementation to the Design Department.

The process is detailed in the Procedure 21-ADP002 “Design Change Management”.

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7.4 PURCHASING

Market Research

Check Supplier List

Purchase feasible?

Offer Analysis

Supplier in List?

Offer ok?

New supplier research

Supplier qualification

process

Incoming documentation receipt

Documentation ok?

End of Process

Furnishement Sample Check

ALL

NO

NO

SI

SI

Purchase Request

Offer request

Purchase order

Documentation request

100% furnishement check

ACQ

ACQ

ACQ

ACQ

NO

SI

NO

YES

ACQ

COLL

COLL

COLL

COLL

ACQ

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SUPPORT PROCESS 3 PURCHASING PROCESS

Purchasing request;Production planned supply needings.

Supply acceptance.

Qualified Supplier List.POE Procedures 21-OP002 / 21-OP003;Purchasing request form;FAI form;

ERP System;Production planning;Market research;Personnel competency.

ACQ INVOLVED FUNCTIONS:

COLL;POA;MOA;APtoDOA.

Nr of incoming non conformities;Delivery time deviation.

Process Needing Resources Process

Responsibilities

Process Monitoring

Process efficiency measurement

HOW?RESULTS

(KPI)?

WHAT? WHO?

INPUT OUTPUT

7.4.1 PURCHASING PROCESS

IHF has established methods and responsibilities to keep under control its purchasing

process, to ensure that purchased products conform to the specified purchase

requirements.

A method has been defined to regulate the selection, evaluation and re-evaluation of

the IHF suppliers, based on their ability and capacity to supply products in accordance

with the IHF requirements. Results of evaluations and any actions arising from the

evaluation is recorded and maintained.

The suppliers management is regulated by the procedure 21-OP002 “Qualificazione,

Auditing e Controllo Fornitori”. This procedure describes the qualification criterion, the

supplier initial assessment and the criterion for the periodical review of its

qualification.

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On this basis IHF maintains a Register of its qualified suppliers that includes the

approval status and the scope of the approval, specifying the product type or the

process/service family.

Supplier performance are periodically reviewed and the results of this review are used

as a basis for its confirmation as qualified supplier and for the determination of the

level of control by IHF on its activity.

The Procedure 9100-OP017 “Analisi statistica e andamento della Qualità” describes the

method to collect and analyze the Supplier Performance in concurrence with the 21-

OP002.

Reference:

Procedure 21-OP002 “Qualificazione, Auditing e Controllo Fornitori”

Procedure 9100-QP017 “Analisi statistica e andamento della Qualità”

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7.4.2 PURCHASING INFORMATION

Purchasing information, describing the product to be purchased, are made available

c/o the supplier or sub-tiers by the Purchasing Department (ACQ) of IHF by means of

formal purchasing order.

All informations and requirements connected to the products manufactured in IHF are

elaborated by the Production Engineering Departments (INP) in accordance to the flow

charts of Key Process 1 “Gestione Vendite” and Key Process 2 “Programmazione e

Realizzazione del Prodotto”. The Production Engineering Department is responsible for

the transmission of the correct informations concerning:

requirements for approval of product, procedures, processes and equipment;

requirement for personnel competency;

quality management system requirements;

revision status of specifications, drawings, process requirements, inspections,

instructions and all the other relevant data;

requirements for design, test, inspection, verification, use of statistical techniques

and related instructions for acceptance;

requirements for notification of non conformities and disposition of non conforming

products;

notification of changes in product and/or process;

record retention requirements;

In the case of products or parts subcontracted outside, the Purchasing Department

(ACQ) assures that such information are timely available c/o suppliers or sub tiers;

Purchasing Department flows down to IHF supplier all the applicable requirements,

including customer requirements.

Every requirement regarding the need for the supplier is reported in the Bilateral

Agreement issued by IHF and undersigned by an IHF representative together with the

supplier one.

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The Procedure 21-OP003 “Gestione Acquisti e conformità in accettazione” regulates

the data information flow, from the request for purchase until the reception of the

product.

Reference:

Procedure 21-OP003 “Verifica della conformità in accettazione”

Bilateral Agreement attached to Procedure 21-OP003

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7.4.3 VERIFICATION OF PURCHASED PRODUCT

Purchasing Needing

Contact the Supplier

Reception of Documentation Complete

Self Evaluation Questionnaire and Bilateral Agreement dispatch

Supplier Classification

Class 1 o 2

Audit Report Evaluation

Supplier Audit

Documentation ok?

Positive Evaluation?

FAI ok?

Insertion in List

Class 3 Supplier

Requirements Research

Requirements ok?

ALL

ACQ

NO

YES

FAI

Insertion Failed

Corrective Action Analysis

Supplier Responsibility?

Insertion Failed

Insertion in List

Non Conformities management

Insertion Failed

ACQ

ACQ

ACQ

INP/HQS/ACQ

INP/HQS/ACQ

INP/PDZ/COLL

ACQ

INP/HQS/PDZ

INP/HQS/PDZ

ACQ

ACQ

ACQ

NO

NO

NO

SI

YES

YES

YES

SI

NO

NO

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SUPPORT PROCESS 6 SUPPLIER

QUALIFICATIONPurchasing demand

Furnisher qualification and insertion in the qualified supplier List.

Qualified supplier list;21-OP002;21-OP003;21-OP006FAI/FAIR.

ERP System;Incoming Inspection;Measurement Tools;

ACQ INVOLVED FUNCTIONS:

INP;RAQ;COLL.

Supplier Reliability Index

Process Needing Resources Process

Responsibilities

Process Monitoring

Process efficiency measurement

HOW?RESULTS

(KPI)?

WHAT? WHO?

INPUT OUTPUT

IHF has established and implemented in the Procedure 21-OP003 (“Gestione Acquisti e

conformità in accettazione”) the inspection activities necessary for ensuring that

purchased product meets the established requirements.

Verification activities can include inspection and audit at the Supplier’s premises and

the evaluation of its Quality Management System; all these activities are accomplished

by IHF in the Supplier qualification phase according to the Flow chart of Support

Process 6 “Supplier Qualification” and the Procedure 21-OP002 “Qualificazione,

Auditing e Controllo dei Fornitori”.

The Right of Entry of IHF organization or its Customers/Authorities, is clearly flow

down to the supplier organization by means of the Bilateral Agreement (BA),

undersigned by an IHF representative and by the audited supplier.

Reference:

Procedure 21-OP002 “Qualificazione, Auditing e Controllo dei Fornitori”

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Procedure 21-OP003 “Verifica della conformità in accettazione”

7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

The IHF has established by appropriate procedures to keep under control the

production activities. The production is planned in accordance to general plan (“Master

Plan”) based on the work orders received. The Control of Production is realized by

means of:

- Operative Instruction;

- Work/Control Cycles;

- Assembly Instruction;

- Configuration Sheets;

- DWG’s;

- Bill of Material;

- Process Specification;

- Suitable equipments (jigs, special tools if applicable, etc);

- Monitoring and measurement equipments;

- Implementation of product release, delivery and post-delivery activities;

- Accountability for all product during production;

- Evidence that all production and inspection activities have been completed as

established;

- Provision for the prevention of FOD;

- Monitoring and control of utilities and supplies affecting the product conformity;

The Company ERP is used to manage the Production Planning and monitor all the

production activities.

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The process is detailed in the Procedure 21-QP005 “Production Processes” and 21-

QP009 “Coordinamento ai fini dell’aeronavigabilità”.

7.5.1.1 PRODUCTION PROCESS VERIFICATION

IHF has implemented the activity referred to as First Article Inspection according to

the flow chart of Key Process 3 “Product Realization”. A representative item from the

first production run of a new part or assembly is used to verify that the production

process, the production documentation and the tooling involved are capable of

producing products that meet the requirements. This process is repeated when

changes occur invalidating the original results.

The process is detailed in the Procedure 21-QP006 “Ispezioni e collaudi”

7.5.1.2 CONTROL OF PRODUCTION PROCESS CHANGES

IHF has identified the Production Engineering Responsible, in collaboration with the

Production Responsible, as the personnel authorized to approve changes to production

processes, production equipment, tools or eventual software programs. These changes

are assessed to confirm that the desired effects have been achieved without adverse

effects to product conformity by means of the process verification as per paragraph

7.5.1.1.

7.5.1.3 CONTROL OF PRODUCTION EQUIPMENT, TOOLS AND SOFTWARE

PROGRAMS

IHF validates all production equipment, tools and software programs used in the

product realization process, prior to release for production, under the responsibility of

the Engineering Production Responsible with the collaboration of the Production

Responsible. The validation process is included in the production process verification

as per paragraph 7.5.1.1 by mean of the First Article Inspection. All the production

equipment and tooling are stored in a defined area for preservation and are

periodically checked under the responsibility of the Production Responsible.

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7.5.1.4 POST-DELIVERY SUPPORT

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KEY PROCESS 3 AFTER SALES MANAGEMENT

Customer claims;Intervention required by customer;Repair Order.

Product timely delivered in compliance to customer requests and applicable CMM;Nr Release to Service;Spare Parts.

MOE;21-OP012 Rilascio Certificati Aeronavigabilità;Capability List;EASA Form 1;Applicable CMM/SB/SL;Airworthiness Directive.

ERP System;Measurement Instruments;Warehouse;Maintenance/Assistance Area;Test Bench;Personnel Competency.

CUSTOMER SUPPORT INVOLVED FUNCTIONS:

MOA;Engineering for ProductionProduction;APtoDOA di IHFE.

Nr of Report claims per customer and per P/N;Nr of Warranty/NonWarranty Intervention;Customer Satisfaction.

Process Needing Resources Process

Responsibilities

Process Monitoring

Process efficiency measurement

HOW?RESULTS

(KPI)?

WHAT? WHO?

INPUT OUTPUT

The activities through which the IHF assures the assistance and the conformity of the

products during the in service use are regulated and documented by the Customer

Support Department. It provides for the action to be taken when problems are

detected after delivery, and for the collection and the analysis of the in-service data.

Concerning the delivered products, IHF is certified as Maintenance Organization from

EASA to provide a maintenance service involving its own products.

The maintenance Processes is carried out in the maintenance area, the specific

Department is separated from the rest of the factory and has a dedicated Maintenance

Organization Exposition (EASA Part 145 Maintenance Manual) and related procedures

and instructions.

7.5.2 VALIDATION OF PROCESS FOR PRODUCTION AND SERVICE PRODUCTION

IHF implements and manages special processes in terms of processes where the

resulting output can’t be verified by measurements or monitoring activities during, or

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at the end of the realization of the product; in these cases eventual deficiencies

become apparent only after the products are in use or in service.

The validation of the process parameter is conducted by means of one or more

qualification tests to demonstrate the ability of these processes to achieve planned

results.

Dedicated Operative Instructions have been issued in order to manage these

processes, including:

overview of the technology used;

key parameters used to control the process and assuring the repeatability of the

process results;

criteria for processes approval and for processes review;

approval of equipment and qualification of personnel;

requirements for records;

criteria for the revalidation.

7.5.3 IDENTIFICATION AND TRACEABILITY

All the products from IHF are suitably identified and their traceability is assured as

shown and detailed in the procedure 21-OP004 Identificazione e rintracciabilità.

For a general assembly, the method in procedure lets to trace its components and

makes it traceable to the next higher assembly; instead for a product a sequential

record of its production steps is retrievable.

The inspection status is visible through authorized stamps, tags, labels, working

documentation indicating the conformity of the products as shown in the procedure

21-OP004 that also describes the control of the stamps used to identify the subject

authorized to perform control and inspection.

7.5.4 CUSTOMER PROPERTY

IHF exercises care with customer property while it’s under its control or when used in

the manufacturing processes. Such a property is identified and protected in the same

manner of IHF own properties. If any customer property is damaged, lost or found

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unsuitable for expected use, Customer Support Department reports opportunely to the

customer maintaining record of it.

7.5.5 PRESERVATION OF PRODUCT

IHF preserves the product during internal processes and delivery, in order to maintain

the conformity to requirements. The preservation of the product includes, according to

product specifications and applicable statutory and regulatory requirements,

identification, handling, packaging, protection and storage.

All material inside IHF are clearly and unambiguously identified by means of different

methods depending on the type of material, its destination and its utilization.

Materials and products handling inside the IHF is carried out in manner to avoid

damages and by mean of adequate handling machines (electric or manual trucks and

forks lift); protection materials are also used as necessary for the same purpose.

IHF makes use of different techniques and materials for products packaging,

depending on the type of product involved. This is carried out in order to avoid

damages (bumps, abrasions etc…) and deterioration caused by environmental effects

(corrosion, superficial modification, product pollution etc.).

Moreover, as necessary, an adequate packaging is carried out in order to ensure a

safe handling.

All the materials and products, inside IHF, are stored in a specific and selected area

(Incoming inspection area, material waiting area, Warehouse) depending on the phase

of the IHF activity involving the material. The up mentioned areas are reserved and

controlled, and only authorized personnel have access to these areas (store personnel

or incoming inspection personnel).

Also in the delivery phase the products are packaged and protected conforming to the

defined requirements, keeping into consideration also the handling operations as well

as the mean of transport used.

At the end of the packaging an apposite label is applied on the pack to identify the

product, the destination and other indication (graphic signs for manipulation) including

possible safety warnings.

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Pertinent documentation, in original or in a copy form, is attached to the pack, until

the final destination.

Reference:

Procedure 21-OP013 “Movimentazione Immagazzinamento e Imballaggio”

7.6 CONTROL OF MONITORING AND MEASURING DEVICES

IHF has implemented a procedure to manage the maintenance and recording of the

monitoring and measuring equipment undertaken; it defines also the process

employed for their calibration and or verification, including datails of the equipment

type, unique identification, location, frequency of checks, check method and

acceptance criteria. IHF assures that the calibration activities and the measurements

are carried out in suitable environmental conditions.

Reference:

Procedure 21-OP007 “Taratura e controllo di apparecchiature e strumentazione”.

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8. MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 GENERAL

IHF has implemented a defined procedure regarding monitoring, measurement,

analysis and improvement processes in order to:

assure the conformity of the product to the required requirements;

assure the compliance of the Quality Management System to the Standard

Reference and Norms;

continually improve the quality of the product and the effectiveness of the Quality

Management System.

The analysis includes determination of applicable methods, such as statistical

techniques, and the scope of their application.

In particular, statistical techniques are used to support:

design process verification;

process control (selection and inspection of key characteristics, process capability

measurements, statistical process control);

inspection;

Failure Mode Effect Analysis, if required.

Reference:

Procedure 9100-QP017 “Analisi statistica e andamento della Qualità”

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8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION

As measurement of the performance of the Quality Management System, the IHF has

determined a method to monitor the information concerning the customer perception

as to whether IHF has met its expectation. A Customer Satisfaction Questionnaire is

regularly issued to get the feedback from the main customer.

The data collected are analyzed in order to determine required improvement,

preventive and corrective actions. All the documents related to customer satisfaction,

are collected by the Customer Support Department and, with the collaboration of the

Quality Assurance Department are inserted in the periodical Review of the Quality

Management System.

This data concern the evaluation of information coming from in service product

conformity, on-time delivery process, customer claims, maintenance warranty

interventions and corrective action plan, when required.

In the flow chart Key Process 3 – “Gestione Post-Vendita” is also described the process

regarding the customer satisfaction.

Reference:

Procedure 9100-QP017 “Analisi statistica e andamento della Qualità”.

Flow Chart Key Process 4 – “Gestione Post-Vendita”

8.2.2. INTERNAL AUDIT

IHF conducts, by means of its Quality Assurance Department, internal audits at

planned intervals to determine whether the Quality Management System:

conforms to the planned arrangements, including customer contractual

requirements, to the requirements of the reference standard normative and to the

Quality Management System requirements established by itself;

is effectively implemented and maintained.

The Quality Assurance Department defines the audit criteria, scope, frequency and

methods, therefore an yearly audit programme is scheduled taking into account both

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the status processes and areas to be audited, and the results of previous audits.

The auditors and the conduct of audits ensure the objectivity and the impartiality of

the audit process. The selection of auditor ensure that he never audits his own

function inside the IHF.

The responsibilities and requirements for the internal audit activities, such as

planning, conducting of audits, reporting results and maintaining records are defined

in the documented procedure 21-QP014.

Reference:

21-QP014 “Audit interni di Qualità e Azioni Correttive”.

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8.2.3. MONITORING AND MEASUREMENT OF PROCESSES

IHF has defined suitable methods to monitor and measure the capability of the Quality

Management System processes to achieve planned results. The methods are selected

considering the type and the extent of monitoring and measurement appropriate to

each processes in relation to their impact on the effectiveness of the Quality

Management System.

When planned results are not achieved and there are process nonconformities IHF

takes appropriate action to:

correct the non conforming process;

evaluate if the process non conformity has resulted in product non conformity;

determine if the process non conformity could affect or could have affected other

process or products;

identify and control any non conforming product.

Process performance are evaluated by indexes and indicators which are object of

analysis during the yearly Quality Management System Review. They take also in

account the quality objectives outlined in the annual Quality Management System

Objectives Plan.

The indexes are usually originated from the following sources:

supplier performance and product performance, as reported in the procedure 9100-

QP017 “Analisi statistica e andamento della Qualità”;

Internal process performance, as reported in the procedure 21-QP014;

post delivery performance, as shown in the flow chart Key Process 3 “Gestione Post-

Vendita”.

Reference:

9100-QP017 “Statistical Analysis and Quality Trend”.

Flow Chart Key Process 3 “Gestione Post-Vendita” “Purchasing Process”.

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8.2.4 MONITORING AND MEASUREMENT OF PRODUCT

IHF has determined the products characteristics that must be monitored and

measured to verify the product has satisfied its requirements; this is carried out at

appropriate stages (tipically incoming, intermediate and final control) of the product

realization process.

The measurement requirements for product acceptance include:

the criteria for acceptance or rejection;

the sequence of the testing operation;

records of the measurement results;

any specific measurement instruments required, and any specific instructions

associated with their use.

Product release and service delivery must not proceed until all the planned monitoring

and measurement activities have been satisfactorily completed, unless otherwise

authorized.

The evidence of conformity, is maintained in records and indicates the personnel

authorizing products release; the same personnel have the responsibility to ensure

that all documents required to accompany the product are present at delivery.

IHF has defined a sampling inspection plan, when using a sampling inspection method,

justified on the basis of statistical principles, applied as mean of product acceptance,

when a sampling inspection method is used.

Procedures 21-OP003 “Verifica della conformità in accettazione” and 21-OP006

“Ispezione e Collaudi” define the processes where the conformity control and

inspection are based on.

Reference:

21-OP003 “Verifica della conformità in accettazione”.

21-OP006 “Ispezione e collaudi”.

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21-OP005 “Processi di Produzione”.

21-OP012 “Rilascio dei certificati di aeronavigabilità”.

8.3 CONTROL OF NON CONFORMING PRODUCT

IHF has established a documented procedure to define the controls and related

responsibilities and authorities for dealing with nonconforming products, including non

conforming products returned by customers, in terms of review and dispositions; such

products must be identified and managed to prevent their unintended use or delivery.

The above mentioned procedure defines:

responsibilities and authorities dealing with the detection of non conformities;

responsibilities and authorities dealing with taking actions to eliminate the detected

nonconformities and to provide the product re-verification;

areas involved in the nonconformities correction process;

eventual criteria and methods to be used to eliminate product nonconformities;

action to be taken when nonconforming product is detected after delivery or during

the in service use. The non conforming product control process reports timely of

delivered non conforming product;

action to be taken to contain the effect of the nonconformity on other processes or

products.

Detected nonconformities are documented by means of approved forms, analyzed

and, when necessary, notified to the customer; all the necessary corrective and

preventive actions are planned, carried out and documented using approved forms by

the IHF.

Dispositions of use-as-is or repair can be carried out after approval by an authorized

representative of the Organization responsible for the product Design; moreover

disposition of scrap causes the product permanently marking and its physically un

usability rendering.

When nonconforming product is corrected it will be re-verified to demonstrate

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conformity to the requirements.

Reference:

21-OP008 “Controllo degli elementi non conformi”.

8.4 ANALYSIS OF DATA

IHF has determined the data to be collected and analyzed to demonstrate the

suitability and effectiveness of the Quality Management System and how to evaluate

where continual improvement of the effectiveness of the Quality Management System

can be made.

The analysis of data provides information relating to:

customer satisfaction (See Flow Chart – Key Process 3);

conformity to product requirements;

On Time Delivery;

characteristics and trends of processes and products, including opportunities for

preventive action, (Audit interni ed Azioni correttive e preventive, 21-QP014)

Suppliers.

The 9100-QP017 “Statistical Analysis and Quality Trend” defines the methods of data

collection and analysis.

Reference:

9100-QP017 “Statistical Analysis and Quality Trend”.

8.5 IMPROVEMENT

8.5.1 CONTINUOUS IMPROVEMENT

IHF continually improves the effectiveness of the Quality Management System through

the use of the Quality Policy, Quality Objectives, audit results, analysis of data,

corrective and preventive actions and Quality Management System review.

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Improvement activities are implemented using the PDCA method (PLAN-DO-CHECK-

ACT) see flow chart in § 5.4

8.5.2 CORRECTIVE ACTIONS

IHF takes action to eliminate the cause of nonconformities in order to prevent

recurrence; the corrective actions are appropriate to the cause of the nonconformities

occurred.

The procedure 21-QP014 “Audit interni ed Azioni correttive e preventive” defines

requirements and responsibilities for:

reviewing nonconformities (including customer complaints);

determining the causes of nonconformities;

evaluating the need for action to avoid the nonconformities recurrence;

determining and implementing actions needed;

records of the results of action taken;

reviewing the effectiveness of the corrective action taken;

flowing down the corrective action requirements to the supplier when the supplier

has responsibility in the nonconformity occurrence;

determining all additional nonconforming products existing involved by the causes

of the nonconformity founded, and taking further action if necessary.

References:

Procedure 21-QP014 “Audit interni ed Azioni correttive e preventive”.

8.5.3 PREVENTIVE ACTIONS

IHF takes action to eliminate the causes of potential nonconformities in order to

prevent their occurrence. Preventive actions are appropriate to the effects of the

potential nonconformities.

The procedure 21-QP014 “Audit interni ed Azioni correttive e preventive” defines

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requirements and responsibilities for:

determining potential nonconformities and their causes;

evaluating the need for action to prevent occurrence of nonconformities;

determining and implementing actions needed;

records of results of action taken;

reviewing the effectiveness of the preventive action taken.

An example of preventive action conducted in IHF is the risk management process, as

shown in flow chart – Support process 1 “Risk Analysis”.

References:

Procedure 21-QP014 “Audit interni ed Azioni correttive e preventive.

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List of Procedure (managed externally)

Procedure Titole Rev. Date

9100-QP016 Gestione Vendite New Gennaio 2012

9100-QP017 Analisi statistiche ed indicatori di processo A Gennaio 2012

9100-QP019 Gestione degli ambienti di lavoro A Gennaio 2012

POE Production Organization Exposition

HB-APDOA Handbool of Alternative procedure to DOA - ETSO