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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
Section 1 QQMM VV
Amdt. 1 Rev. Orig.
30 Nov 2015
AASS//EENN 99110000 Page 2 of 95
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
Section 1 QQMM VV
Amdt. 1 Rev. Orig
30 Nov 2015
AASS//EENN 99110000 Page 94 of 95
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.
Section 1 QQMM VV
Rev. D
19 May 2014
AASS//EENN 99110000 Page 95 of 95
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