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Quality, Environmental, Safety Manual

MQAS Revision 1 dated 15/11/2004 Page 1 of 53

Edition Date Nature of change


Addition of matrix of responsibilities, explanation of environmental
1 15.11.2004
objectives, updating of general organization chart
ISO 9000:2000 update and addition of management systems for
0 24.10.2003
the environment and safety

COMPILED BY APPROVED BY AUTHORIZED BY


Quality Assurance Quality Assurance General Management
Giovanni Faoro Giovanni Faoro Francesco Basso

COELME Costruzioni Elettromeccaniche S.p.A. – via G. Galilei ½ - 30036 Santa Maria di Sala – Venezia ITALY
Tel. +39 041 486 022 - Fax. +39 041 486 909 - coelme@coelme.it
This document is the property of COELME Costruzioni Elettromeccaniche S.p.A. and cannot be copied, reproduced or revealed to third parties according to the law
provisions in force.
Quality, Environmental and Safety Manual
MQAS Revision 1 dated 15/11/2004 Page 2 of 53

CONTENTS
Section Title Page
0 COELME 4
0.1 Brief history 4
0.2 Milestones of COELME's history 6
0.3 The COELME product range 7
0.4 The COELME market 9
0.5 Location of facility 10
0.5.1 Directions to COELME facility 11
0.6 Organization 12
0.7 Current Management Systems 12
1 Integrated company management system manual 14
1.1 Purpose 14
1.2 Handling of the Manual 14
1.3 Periodic Examination 14
1.4 Distribution 14
1.5 Field of Application 14
2 References 15
2.1 Standards 15
2.2 Definitions 15
3 Integrated quality, environmental and safety company management system 16
3.1 Description of COELME's Primary Processes 16
3.2 Interfunctional Matrix of Responsibilities 19
4 Processes relating to the environment and occupational health 20
5 Structure of integrated system documentation 21
5.1 Integrated Manual 21
5.2 First-Level procedures 21
5.3 Detailed procedures 22
6 COELME Costruzioni Elettromeccaniche S.p.A. Policy 23
7 Quality, Environmental and Health Planning 24
7.1 Quality Planning 24
7.2 Identification of environmental aspects 24
7.3 Identification of dangers and risk assessment 24
7.4 Legal and other requirements 25
7.5 Environmental and worker health objectives and targets 25
7.6 Environmental Management Programme 26
8 Organization 27
8.1 COELME organizational structure 27
8.1.1 Management representatives 27
9 Application of Standard ISO 9001:2000 29
9.1 Communication 29
9.2 Management review 29
9.3 Resource management 30
9.3.1 Human Resources 30
9.4 Infrastructure 30
9.5 Worker wellbeing and satisfaction 31
9.5.1 Work Environment 31
9.6 Product Realization 31
9.6.1 Planning of product realization 31
9.6.2 Customer-related processes 32
9.7 Design and development 32
9.7.1 Organizational setup 32
9.7.2 Planning 33
9.7.3 Review 33
9.7.4 Verification 33
9.7.5 Validation 34
9.7.6 Industrial design engineering 34
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9.7.7 Changes to the design 34


9.8 Purchasing 35
9.8.1 General 35
9.8.2 Supplier assessment 35
9.8.3 Purchasing data 35
9.8.4 Verification of purchased product 35
9.8.5 Environmental and safety aspects 35
9.9 Production 36
9.9.1 General 36
9.9.2 Identification and traceability of product 37
9.9.3 Preservation of product 38
9.9.3.1 Handling 38
9.9.3.2 Storage 38
9.9.3.3 Packaging 38
9.9.3.4 Preservation 38
9.9.3.5 Delivery 38
9.10 Control of monitoring and measuring devices 39
9.11 Measurement, Analyses and Improvement 40
9.11.1 General 40
9.11.2 Measurement of Customer satisfaction 41
9.11.3 Internal audits 41
9.11.4 Monitoring of processes 42
9.11.5 Monitoring of product 42
9.11.6 Receiving inspection and testing 42
9.11.7 In-process inspection and testing 42
9.11.8 Final inspection and testing 42
9.11.9 Monitoring and measurement of environmental and safety aspects 43
9.12 Disposition of nonconformities 44
9.12.1 Product nonconformity 44
9.12.2 Internal nonconformity 44
9.12.3 Nonconformity at customer's premises (complaints) 45
Environmental and health-related nonconformity and management of
9.12.4 45
emergencies
9.12.5 Analysis of data 46
9.12.6 Improvement 46
9.12.6.1 General 46
9.12.6.2 Corrective and preventive action relating to quality 46
Corrective and preventive action relating to the environment and
9.12.6.3 47
health: accident, injury and potential hazard report.
Correspondence between first-level procedures and ISO 9001:2000 - ISO
10 48
14001:1996 with first-level procedures
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0 COELME
0.1 Brief history

COELME was founded in 1975, a product of the Veneto region's business


initiative. Bravely taking up the challenge thrown down by profitable market
opportunities, it has successfully catalyzed some of the top experts in the field of
electromechanics around a well-defined industrial project, exploiting their know-
how and professionalism in the business of overhead line fittings and substation
connectors and medium-, high- and extra high-voltage disconnectors.

The first products bearing the COELME brand were overhead line fittings
and substation connectors. Following that, COELME started designing, producing
and marketing medium- and high-voltage disconnectors, becoming the driving
force behind a progression in turnover growth and behind the expansion and
diversification of the company's products and markets.
As a matter of fact, over the years COELME has improved, increased and
differentiated its product range to include an extensive assortment of standard
products. At the same time, though, it has displayed great flexibility and skill in
designing and producing special equipment, such as the extra high-voltage DC
disconnectors for the Italy-Greece power connection.
COELME today designs and produces electromechanical equipment to
meet a whole host of different, exacting market demands in terms of quality,
reliability and performance.
With the launch of its disconnector business unit, COELME has
undertaken the marketing of EGIC products at a world level, thus completing the
range with devices not yet manufactured in house.
The range currently includes medium - high - extra high-voltage
disconnectors up to 550 kV – 6300 A.
COELME has established itself as a market leader and is seen as a
privileged supplier in its business, not just in Italy (where it is one of the few
suppliers with its own type-approved products conforming to the stringent
specifications of the Italian electricity board ENEL and State Railways), but
Quality, Environmental and Safety Manual
MQAS Revision 1 dated 15/11/2004 Page 5 of 53

abroad too, by virtue of numerous supplies delivered to national electricity boards


whether directly or through major contractors.
These results are attributable to the skill of the employees and to company
management constantly geared towards customer satisfaction, whose inspiring
and guiding principle is total company quality. This has allowed COELME to
attain certification of its company quality system, in 1994, in conformity with
standard ISO 9001.
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0.2 Milestones of COELME's history


1979
1978 First Order for 1986
1975 First Order for High-Voltage ENEL Approval of
First Order Substation Disconnectors Disconnectors for 1989
for Overhead Connectors Distribution 145 kV Order for Busbars
Line Fittings 18,300 A - 24 kV

1975 ÷1990
1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990
1975 1990

2001
New SLOB 2003 - 2004
1999 Vertical Disconnector New
New ENEL Approval UNI EN ISO 9001:2000
1995 of Disconnectors for 2000 &
ENEL Approval of Transmission High-Voltage DC UNI EN ISO 14001:1996 2004
Disconnectors for 420 kV Disconnectors 420 kV Development and
Certifications
Transmission (Italy-Greece Application of Vacuum
1994 420 kV 1997 power connection) 2002 and SF6 Technology
Marketing of Entry into
2004
UNI EN ISO Composite
9001:1994 550kV “Business Unit”
Disconnectors Insulators
Certification

1991 ÷ 2004
1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
1991 2004
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0.3 The COELME product range

The Santa Maria di Sala facility near Venice is home to the design and manufacture of the high-voltage equipment illustrated in the
table below for electric power generation, transmission and distribution substations:
Side Break Vertical Break Vertical Break
Separation of 2 conductors at same level Separation of 2 conductors at different levels Separation of 2 conductors at same level

Centre Break Double Break Pantograph Semi-Pantograph Vertical Break Vertical Break knee type

36 kV Å Å Å
72-100 kV Å Å Å Å
123 kV Å Å Å Å
145-170 kV Å Å Å Å Å
245 kV Å Å Å Å Å
300-420-550
kV
Å Å Å Å Å Å
800 kV Å Å
Rated Current Up to 4000 Up to 4000 Up to 4000 Up to 4000 Up to 4000 Up to 6300
Short-
Circuit ≤ 50 kA/3 sec 75 kA/3 sec 63 kA/3 sec 63 kA/3 sec 63 kA/3 sec 75 kA/3 sec
Current

72-100-123 kV 145-170 kV 245 kV 300-420-550 kV

Independent
Earthing Switch
Short-Circuit
Current
Up to 75 kA/3 s
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Centre Break Double Break Pantograph

Semi-Pantograph Vertical Break Earthing Switch


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0.4 The COELME market


COELME's is a worldwide market. The most important installations are indicated on the world map below.
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0.5 Location of facility


COELME's headquarters and factory, initially located in a small town in the
neighbouring province of Padua, came to Santa Maria di Sala in the province of
Venice in 1985, setting up in the industrial area of a small town positioned
roughly the same distance from Padua, Treviso and Venice.
With Venice's international airport "Marco Polo" nearby and the A4
motorway just a short distance away, not to mention Mestre's and Padua's
respective train stations - two railway hubs of national importance - the
company's headquarters is easy to reached for people, means and materials
alike.
T re rom
o
vis
F

S. Maria di Sala
Industrial Area

S.S. 515
ST y
I E rwa
E
T R to
ale

to Mo
Riv

S. Maria di
A4
V ia

s
ari

Sala
er r

Fr
.F

om
le G

M
Pa rom
va

Do estr
Via
do

lo e -
F

- M Ve
ira ne
i
alile

n o z ia
.G

“Tangenziale” bypass
G

M
Via

ir a MARCO
no
S. M aria

/ S To POLO
.M International
S. Ma

ar Airport
ia
To

di
S
ri
To

di Sala

ala
a di

PADOVA EST A4
S ala

Exit MESTRE
To
MILANO
DOLO - MIRANO
To Exit
VENEZIA

PADOVA

VENEZIA
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0.5.1 Directions to COELME facility

From Venice • If you are on the A4 motorway heading towards Milan, take the Dolo-
Mirano exit.
• Follow signs for S. Maria di Sala and go through the town.
• Once you've gone through S. Maria di Sala, take the SS 515 trunk road
and continue towards Padua.
• After approx. 300 metres, take a left onto Viale G. Ferraris.
• Continue down the road for about half a kilometre, following it round to
the right and, about a hundred metres further down, turn left onto Via G.
Galilei - COELME's headquarters is at the end.

From Padua • If you are on the A4 motorway heading from Milan towards Venice, take
the Padova Est exit.
• Follow signs for Treviso, driving along the SS 515 trunk road for approx.
15 kilometres, passing through the towns of Vigonza and Mellaredo.
• Once you've reached and gone through Tabina di Santa Maria di Sala,
the SS 515 trunk road makes a very wide 90° bend.
• After approx. 400 metres, take a right onto Via Rivale.
• Continue down the road for about half a kilometre and then take a left
onto Via G. Ferraris.
• About a hundred metres down the road, turn right onto Via G. Galilei -
COELME's headquarters is at the end.

From • Once on the SS 515 trunk road heading towards Padua, after going
Treviso through Quinto di Treviso, Zero Branco, Scorzè, Noale and Stigliano, go
through the town of Treponti and keep going for about 3 kilometres.
• At this point (with Villa Farsetti on your left), the SS 515 road makes a
rather sharp 90° bend to the right.
• After approx. 300 metres, take a left onto Viale G. Ferraris.
• Continue down the road for about half a kilometre, following it round to
the right and, about a hundred metres further down, turn left onto Via G.
Galilei - COELME's headquarters is at the end.
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0.6 Organization
COELME Costruzioni Elettromeccaniche S.p.A.'s organization features
five main departments and a set of secondary company departments that either
fall under the various main departments or answer directly to the General
Management.
The basic organization chart is illustrated below.
The General Management reports directly to the Board of Directors.

Board of Directors

General Management

Management Secretary's Office Q. A. S. - Quality, Environment and Safety

Quality Assurance Department IT Department

Company Services

Sales Department Accounting and Finance Quality Control Department Manufacturing Department Technical Department
Department

Order Management Human Resources Quality Control Order Management

Offers Finace Research & Developement Research & Developement

(*) Note

Marketing Administration Services Planning

Management Control
Reporting
e Reporting
Purchasing Industrial Engineering
Department Warehouse Dept. Production
Costs & Methods

Strategy Inventory Workshop


Management

Accounting Programming
Dispatch
& Reporting & Reporting

Accounting
Purchasing
& Reporting
(*) Note
Research and development activities are coordinated by the Technical Department's R&D: personnel from the Quality Control Department
are also essentially involved in these activities for the performance of development tests.

0.7 Current management systems


COELME Costruzioni Elettromeccaniche's company organization has
always been geared towards continual improvement and designed to achieve
customer satisfaction.
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ISO 9001:1994 certification, awarded towards the end of 1994, therefore


proved the natural formal acknowledgement of a management procedure already
meeting the requirements of the reference standard.
With awareness of environmental and safety issues reaching ever-higher
levels, and continual improvement geared towards customer satisfaction, in the
widest acceptation of the term, which also includes the 'internal customer'
acceptation, COELME has advanced and steered operational decisions towards
new management scenarios implying greater and more binding restrictions in
terms of environment and safety matters.
As part of a multi-year plan, COELME - partly to limit the extent of
resources to be channelled into implementing a fully integrated management
system - has planned to attain Quality&Environmental certification in conformity
with ISO 9001:2000 and ISO14001 before the end of the year, whilst safety
certification in conformity with OHSAS 18001 has been put off to next year.
The road to certification will lead to integration between the different
management systems as illustrated in the graphical schematic representation
below, which must be applied at a management, document, organizational and
operational level.

Quality
&

NIC Q NIC A
Environment

Quality Environment
Quality
Environment
Safety
Quality Environment
& &
Safety Safety

NIC S
Safety

The intersecting areas will be attributed in terms of document priority to


the Quality management system, i.e. for essentially historical reasons.
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1 INTEGRATED COMPANY MANAGEMENT SYSTEM MANUAL


1.1 Purpose
The purpose of the Manual is to furnish a description of the Integrated
Quality, Environmental and Safety Management System created by COELME
Costruzioni Elettromeccaniche S.p.A. and intended to act as a constant reference
in the application, updating and implementation of said system.

1.2 Handling of the Manual


The Manual is a document of a general nature applicable to the company
and handled by the Quality Assurance Department.
Handling of the Manual and its appendices includes the following tasks:
• periodic examination and updating;
• distribution of the Manual and updates;
• filing previous versions.

1.3 Periodic examination


If a change is required following company reorganization of some kind, it is
the responsibility of the Quality Assurance Department to produce the new
edition.
Each new edition is authorized by the Management and identified with a
new revision number. A short description of the nature of the changes is given on
the first page of this Manual.

1.4 Distribution
The Manual is available to all employees off the company's computer
network in a protected form, with the head of the Quality Assurance Department
given full control.
There are just two controlled copies of the Manual, held respectively by:
• Quality Assurance Department;
• certification body.
Other uncontrolled copies of the Manual can be distributed outside the
company via email or in hardcopy.

1.5 Field of application


The Manual is applicable inside the COELME Costruzioni
Elettromeccaniche facility for all Quality, Environmental and Safety matters.
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2 REFERENCES
2.1 Standards
This Manual makes reference to the following Standards:
Field Standards

Quality • UNI EN ISO 9000:2000 Quality management


systems - Fundamentals and vocabulary.
• UNI EN ISO 9001:2000 Quality management
systems - Requirements
• UNI EN ISO 9004:2000 Quality management
systems - Guidance for performance improvement

Environment • UNI EN ISO 14001 Environmental management


systems - Requirements with guidance for use
• UNI ISO 14004 Environmental management
systems - General guidelines on principles, systems
and support techniques
Quality • ISO 19011 Guidelines for quality management
& and/or environmental management system audits
Environment

Safety • OHSAS 18001 Occupational health and safety


management systems - Specifications
• OHSAS 18002 Guidelines for the implementation of
OHSAS 18001

2.2 Definitions
For the purpose of this Integrated Quality and Environmental Manual,
reference is made to the definitions given in the following Standards:
Field Standards

Quality • UNI EN ISO 9000:2000 Quality management


systems - Fundamentals and vocabulary;

Environment • UNI ISO 14050:2002 Environmental management –


Terms and definitions.
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3 INTEGRATED QUALITY, ENVIRONMENTAL AND SAFETY COMPANY


MANAGEMENT SYSTEM
3.1 Description of COELME's Primary Processes
COELME Costruzioni Elettromeccaniche's business can be narrowed
down into primary processes, which can in turn be broken down into sub-
processes, where necessary. The logical flow of these processes can be
represented in the following diagrams (Figures 1-2).

Managerial Process
Performance
Process Management

Core
Business
Technical Manufacturing
Department Department

Improvement

Customer Sales Department Customer

Core Business Support Functions


Quality Control
Administration & Accounting

Company Support Functions Colour Key

Human Resources Management


Quality - Environment - Safety
IT and ERP Core Business
Company Services
Support

Fig.1 - COELME Costruzioni Elettromeccaniche S.p.A.'s key processes


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Core Business
Managerial Process
Performance
Process Management

Technical Department Manufacturing Department


Industrial
Research &
Engineering
Developement
Department

Technical Order Purchasing


Programming
Management Department

Warehouse
Department

Improvement Production

Dispatch
Department

Customer Offers
Order
Management Customer
Sales Department

Fig.2 - Definition of COELME Costruzioni Elettromeccaniche S.p.A.'s key Core


Business processes

Mission Description
Managerial Planning and Plan and manage COELME business so as to
Process general suitably meet customer requirements and
management constantly evolving market demands.

Quality, Plan and manage activities in terms of Quality,


Environment and Environment and Safety in line with provisions of
Safety the ISO standards for certified Quality
Management and Environmental Management
Systems and, with respect to the Safety
Management System, standard OHSAS 18001.
Verify attainment of predetermined quality,
environmental and safety objectives at all stages
of the production process; implement solutions to
remedy nonconformities; and take any corrective
action needed.
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Offer improvement Determine, verify and implement actions designed


to increase customer satisfaction with reference to
products and services marketed or undergoing
industrial engineering.
Process Determine, verify and implement actions designed
improvement to increase process performance.
Environmental Determine, verify and implement actions designed
impact improvement to improve process performance so as to reduce
environmental impacts with respect for natural
resources and the community's resources.

Mission Description
Core Offer Management Management of offers by the Sales Department's
Business Purchasing, including all related activities, is
governed by a specific procedure.

Order Management Management of orders by the Sales Department's


Order Management, including all related activities,
is governed by a specific procedure.
Design and Order Design is based on a number of modular product
Development types, which can be tailored in different ways to
the customer's demands. This means a whole
range of different market requirements can be met.
Purchasing Ensure that raw materials, manufactured parts,
components and subassemblies required for
production are promptly available, in compliance
with the applicable specifications.
Production Carry out product manufacturing, in compliance
with the order specifications, in terms of cost,
quantity, quality, service, based on precise
references.
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3.2 Interfunctional Matrix of Responsibilities

Accounting Finance Department


Quality Assurance Department
Interfunctional Matrix of

Quality Control Department

Manufacturing Department
Responsibilities

Technical Department
General Management

Sales Department
R = Responsible A = Assists

Point of Standard UNI EN ISO 9001:2000


Standard Clause Standard Requirements
4 Quality and Environmental management system
1 4.1 • General requirements
4.2 A R A A A A A
• Documentation requirements
5 Management Responsibility
5.1 • Management commitment
5.2 • Customer focus
2 5.3 • Quality policy
5.4 • Planning R A A A A A A
5.5 • Responsibility, authority and communication
5.6 • Management review
6 Resource Management
6.1 • Provision of resources R A
3 6.2 • Human resources A R
6.3 • Infrastructure
R A
6.4 • Work environment
7 Product Realization
7.1 • Planning of product realization
7.2 • Customer-related processes A A R A A A A
4 7.3 • Design and development A A A A R
7.4 • Purchasing A A R
7.5 • Production and service provision A R
7.6 • Control of monitoring and measuring devices R A
8 Measurement, Analyses and Improvement
8.2 • Monitoring and measurement
A R A
5 8.3 • Control of nonconforming product
8.4 • Analysis of data A R
8.5 • Improvement R A A

Point of Standard UNI EN ISO 14001:1996


Standard Clause Standard Requirements
4 Planning
4.3.1 • Environmental Aspects
R
4.3.2 • Legal and other requirements
4 4.4.3 • Communication R
4.4.6 • Operation Control R A A
4.4.7 • Emergency preparedness and response R A
4.5.1 • Monitoring and measurement R A
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4 PROCESSES RELATING TO THE ENVIRONMENT AND OCCUPATIONAL


HEALTH
Processes relating to the environment and health at work describe the
ways in which regulations and policies are applied in the company to ensure the
laws, company rules and COELME policy are complied with.
The flow featured in Fig. 3 conforms to standards UNI EN ISO 14001 and
OHSAS 18001 and represents the process relating to the management of the
environment and occupational health in the integrated management system.
The process is not an end in itself, rather it is spread in an integrated
manner throughout the activities performed in the facility where the
Environmental Management System and Safety Management System are
implemented.

Environmental and Non conformances


Safety Compatibility Corrective and
of Products Preventive Action

Identification of
Environmental Aspects: Measurement and
Environmental Analysis Control of
Legal requirements Monitoring of
Environmental,
and control of Environmental,
Safety and Health
Identification of fulfilment register Safety and Health
Aspects
dangers and risk Aspects
assessment

Management of Emergencies

Fig. 3 - Flowchart applied to environmental management and occupational health


management
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5 STRUCTURE OF INTEGRATED SYSTEM DOCUMENTATION


Documents for the Integrated System's implementation are ideally split
into three document levels.

Integrated Quality
Environmental
Safety Manual
MQAS

NIC Q
First-Level
NIC A - NIC S Procedures
COELME Internal Procedures
Quality - Environment - Safety

Work Instructions Detailed


Procedures

System Product

5.1 Integrated Manual


This is the only document to be distributed outside the company, used to
describe and apply the Integrated System.
It furnishes a suitable description of the quality, environmental and safety
management system in force at COELME and is a constant reference for the
application of said system.
In addition to the company's organization, it contains a summarized
description of activities, referring to necessary procedures, operational functions
and responsibilities.

5.2 First-Level procedures


These are the documents describing, where necessary, the procedures
through which the requirements expressed by the standards UNI EN ISO 9001,
UNI EN ISO 14001 and OHSAS 18001 are applied at COELME at a general level
for the individual management system.
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5.3 Detailed procedures


These are the documents designed to assure correct application of the
Integrated System in all operational activities carried out at COELME.
To achieve correct, effective management, they are divided up - with
reference to a general application or a specific product - into system work
instructions and product work instructions.
Various forms are associated with the above-mentioned documents. Once
filled out, they become quality and environmental records. The relevant handling
procedures (issuance, filing, safekeeping etc.) are covered in specific
procedures.
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6 COELME COSTRUZIONI ELETTROMECCANICHE S.p.A. POLICY


COELME is committed to complying with the most stringent requirements on
the subject of quality, occupational health and safety, as well as the protection of
the environment, which are part of the integrated management system.
The integrated company management system systematically integrates
quality, occupational health and safety aspects with environmental protection
employing the same methods and structural setup.

Within this overall framework, we have decided to consider the


"CUSTOMER" as our primary objective, and in this context we intend to:
Become familiar with our customer;
Understand and anticipate the customer's needs;
Meet not just the customer's explicit needs, but implicit needs, too;
Provide competitive advantages.

We are convinced that this can be achieved through:


Commitment to achieving improvements every day;
Proposing solutions, not justifications;
Attaining measurable results;
Motivating all personnel;
Improving technical and organizational synergies with other companies in the
relevant group;
Maintaining and improving company profitability;
Acknowledging and rewarding best performances.

On the technical side of things, we believe we must:


Develop and maintain a leading level of technology;
Introduce continual improvements in processes;
Come up with innovative, reliable products and solutions;
Work together with the customer to seek value-adding solutions;
Change our competencies, turning from product suppliers into partners who can
offer innovative, comprehensive technological solutions.

In our activities as a whole, we undertake to:


Comply with all applicable rules and legislation, prevent any form of pollution and
safeguard the health of all workers;
Maintain an active conduct, aware that we can contribute to improving the
environment within the company, within the community we work in, and outside,
at our suppliers' premises and those of users employing our products;
Integrate environmental protection methods in the researching, designing and
fine-tuning of the company's products and processes - production processes and
otherwise - as well as the relations with interacting parties (suppliers, customers,
authorities etc.);
Improve environmental culture and training and health of personnel;
Determine and document environmental improvement objectives and check their
attainment by measuring their impact on savings in terms of resources such as:
water, gas, electricity, reduction of scrap, swarf and waste.

The Chairman
Francesco BASSO
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7 Quality, Environmental and Health Planning


7.1 Quality Planning
Through the Integrated System documentation, COELME plans, defines
and documents the activities required to meet the quality requirements. In quality
planning, special attention is placed on defining relevant procedures to govern
processes that are essential to assuring quality of products and services supplied
as well as continual improvement.

7.2 Identification of environmental aspects


Using special procedures, COELME identifies and evaluates the
environmental aspects of its activities, products and services that it can monitor
and over which it exerts an influence so as to determine which of them have or
may have significant impacts on the environment.
The environmental analysis is the starting point or update based on which
these aspects can be identified as can the organization's actual ability to control
them.
Identification and evaluation of environmental aspects must be updated
whenever there are changes to methods or evaluation criteria, or when changes
are planned for processes and activities carried out in the facility, so as to ensure
a preventive evaluation is made of environmental aspects associated with such
changes.
In particular, environmental aspects associated with the use of new
materials (raw and/or auxiliary materials) and/or new products must be identified
beforehand. In this case, an evaluation will be made whenever it is called for.
The results of the initial environmental analysis and its later updates are
taken into consideration by the production facility, in the definition of objectives
and environmental targets.

7.3 Identification of dangers and risk assessment


Worker health and safety and accident prevention activity, which is the
responsibility of the occupational safety and risk management department and
the company health department, is managed by procedures designed to
determine potential risks, assess the risk and implement measures to
reduce/eliminate said risk.
Safety and health risks are identified and assessed through the following
stages:
Identification of danger;
Assessment and rating of risks associated with company activities both in
terms of probability and seriousness, and consequent measures adopted;
Decision on tolerability of said residual risks;
Identification of any additional control measure deemed necessary;
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Assessment of said measures to see whether they are sufficient to reduce


the risk to a tolerable level;
Improvement programme.
The process entails a series of activities, which include: examining risks
related to individual tasks, conducting inspections in the workplace, preparing a
health protocol, performing health checks imposed by the protocol, assessing
reports both at an individual and group level, and drawing up health files for each
worker. The Competent Doctor, through the information system, correlates the
health files with the health and hygiene risk assessments.
The Occupational Safety and Risk Management Department Manager
(OSRMD Manager) determines and compiles job sheets containing risks
associated with each job, indicating the extent of risks and determining what PPE
(Personal Protective Equipment) should be used as well as defining the job in
question. The thus-determined risks are assessed, after which the next step is to
measure and carefully weigh the collective risks associated with each job.
Workers are informed of aspects brought to light during safety meetings. Said
meetings are held at regular intervals during the course of the year.
The OSRMD Manager determines measures required to reduce/eliminate
the risk. Said measures are then carefully examined, taking into account reports
of accidents, potential accidents and injuries. The proposal is examined by the
Management, after which it is formally recorded and entered in the official plan of
risk reduction/elimination measures. The job sheets and results of the risk
assessment activity are recorded and filed in the risk assessment document.

7.4 Legal and other requirements


The nature and volume of company activities enable the company to
define the legal and normative requirements that must be applied.
These requirements, together with the industry's codes of good practice
and other non-legal technical sources, are the reference referred to for company
problem matters.
The main documents taken as reference for the environment are recorded
on the standard's register, and there is a procedure in force to ensure that
relevant laws and regulations are identified over time along with procedures for
handling the fulfilment of associated obligations.

7.5 Environmental and worker health objectives and targets


Environmental and worker health objectives and targets are defined
coherently with the Quality Policy. Environmental objectives and targets are
defined by the General Management, with input from the Occupational Safety,
Risk Assessment and Environment Dept. Manager and the other functions, as
part of the annual operational planning and of the continual performance
improvement process. In addition to Company Policy, definition of the objectives
and targets takes into account the continuously updated evaluation of significant
environmental impacts, the risk assessment and evaluation of applicable
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regulations, the best technologies and financial resources available, as well as


the organization's operational and business requirements.
General environmental objectives are as follows:
reducing the amount of natural resources used;
reducing the amount of waste produced;
using natural resources compatible with the environment and with
sustainable development;
promoting and developing more energy-efficient products and
production technologies, with a low environmental impact;
prevention and protection of the environment.
The detailed definition of objectives and determination of targets is
formulated during the management review meeting.

7.6 Environmental Management Programme


All objectives and targets relating to quality, the environment and health
can be associated with a Plan of Action defined by the Management, whose
implementation is then entrusted to the various Department heads.
The formally recorded Plans of Action are the base of the Management
programmes.
Each Plan of Action gives a detailed description of the activities and tasks
that must be carried out to achieve the objective, and features the investments
required in terms of means and resources. Through the Plan, the progress of
activities can also be verified. The investments and training activities required are
submitted to the General Management for approval.
The Plans of Action relating to new installations or product, process or
service changes must incorporate actions to prevent and improve environmental
impacts and to protect health.
The person in charge of a Plan of Action will take the actions required to
attain the objectives, both directly and by setting one or more workgroups in
motion.
It is the responsibility of the person in charge of the Management System
involved to verify the progress of the Plans of Action in order to assess risks and
any difficulties that might be encountered and, depending on the case, decisions
will be taken as to what changes, planning updates and/or recovery action are
needed.
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8 ORGANIZATION
8.1 COELME organizational structure
8.1.1 Management representatives
Quality

To make sure that regulations relating to the Quality Management System


are applied efficiently and effectively, COELME's General Management, as
appropriate to the organization introduced:

APPOINTS

Mr. Giovanni Faoro as the Management Representative for Quality matters


according to the terms indicated in standard UNI EN ISO 9001:2000.

General Manager
Francesco Basso

Environment

To make sure that regulations relating to the Environmental Management


System are applied efficiently and effectively, COELME's General Management,
as appropriate to the organization introduced:

APPOINTS

Mr. Giovanni Faoro as the Management Representative for Environmental


matters according to the terms indicated in standard UNI EN ISO 14001:1996.

General Manager
Francesco Basso
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Safety

To make sure that regulations on Work Safety and Hygiene, Ecology and
Fire Prevention are applied efficiently and effectively, COELME's General
Management, as appropriate to the organization introduced:

APPOINTS

Mr. Stefano Girardin, by means of a power of attorney, as the Management


Representative for Occupational Health matters, according to the terms dictated
by the legislation in force and as expressed in standard OHSAS 18001.

General Manager
Francesco Basso
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9 APPLICATION OF STANDARD ISO 9001:2000


9.1 Communication
The purpose of communication, which may be directed at in-house
personnel or third parties, is to:
• show the Management's involvement in activities related to quality and
to the protection of the environment and health;
• promote awareness of COELME's Integrated Policy;
• provide information on quality and environmental and health objectives
and performance, as well as on the results of measures, checks and
audits;
• make the people concerned aware of rules of conduct concerning
quality and the environment and health (with particular reference to
binding laws and provisions);
• meet legal requirements on environmental and health matters.

To inform its personnel, COELME puts up written notices and, where


possible, employs commonly used computer tools (email) as its preferred means
of communication.
Voluntary communication aimed at third parties working in the facility
concerns risks and significant environmental aspects associated with the
activities carried out. These information activities are conducted according to
precise methods indicated in specific procedures.
Compulsory communication concerning environmental and health matters,
for the purpose of meeting legal obligations or complying with requests coming
from Control Bodies, is done according to the methods indicated in the specific
procedure. How the receiving of relevant documents and replies are handled is
also dictated by the methods indicated in the document handling procedure.
For information coming from operators, it shall be the responsibility of the
department heads or occupational safety officers to gather said news and make it
known to the Manager of the Occupational Safety, Risk Assessment and
Environment Department.

9.2 Management review


The Integrated Company Management System, in addition to being
monitored, in terms of effectiveness, is subject to review, at least twice a year, by
the Management to ensure that it is suitable and effective in meeting the
requirements of the standard, policy and established quality and environmental
objectives.
The elements considered during the review are mainly those relating to
customer satisfaction, indicator trends, the progress of plans of action, and the
discussion of first-, second- and third-party audits with verification of the situation
of any corrective action that has been taken following the detection of
nonconformities.
Said reviews are filed according to the provisions of the specific
Procedure.
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9.3 Resource management


9.3.1 Human resources
The effectiveness of the Integrated Management System depends directly
on the training and motivation of the company's personnel. Hence:
• rules have been established both for the management of training in
general and for the provision of training to company personnel
performing activities affecting quality, the environment and health of
workers (with particular attention on the 'needs identification - planning
and implementation of measures - verification of effectiveness' cycle);
• personnel performing certain activities affecting quality, the
environment and health are qualified/authorized based on adequate
training courses and/or by being teamed with previously trained, expert
personnel;
• the level of the personnel's recognized competence, especially of
operators, is given in special matrices known as "Multiple skills tables".
As for the specific aspects of integrated quality, environmental and health
management, all personnel receive awareness-building training on:
• the importance of conformity to Quality, Environmental and
Occupational Health Policy, to procedures and requirements of the
Integrated System;
• the significant environmental impacts, real or potential, and the risks
resulting from activities carried out in the facility;
• benefits for the environment achieved through the success of plans of
action intended to reduce environmental impact;
• the roles and responsibilities of personnel given the task of taking
action in emergency situations;
• the associated dangers and risks.
A Job Description document is prepared by the Human Resources
department for all clerical personnel. The Job Description, intersecting the
different requirements making up the job profiles with the degree of skill
possessed for each by each employee, can thus highlight any shortcomings as
well as outstanding performance in training. These results help in determining
what direction each individual's training should take.
A record is kept for each kind of training carried out.

9.4 Infrastructure
An integrated company management information system known as
"Galileo Visuale" has been adopted to support the various activities (processes)
carried out. The specific purpose-built quality management application known as
"Galileo Qualità" runs on this system, interacting with it.
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9.5 Worker wellbeing and satisfaction


9.5.1 Work environment
COELME has always been aware that nothing is more important than the
health and safety of its employees. This is why the company has been committed
to assessing the risks associated with production activity and to defining,
pursuing, disseminating and periodically reviewing (by means of plans of action
and meetings with the Management, Company Doctor, Worker Safety
Representatives and OSRMD Manager) improvement objectives such as:
• minimizing or eliminating risks that can be associated with the
company's processes, producing healthy, safe and pleasant work
conditions for employees (optimizing workplace temperature as much
as possible);
• setting concrete improvement objectives, especially in terms of
reducing noise in the workplace and the amount of solvents used, and
the prompt preventive maintenance of atmospheric emission vacuum
systems;
• evaluating every process change, every replacement of substances or
machinery used, also taking into account the effects said changes may
have in terms of occupational health and safety, always intended to
reduce the degree of dangerousness associated with them;
• checking the healthiness of workstations with monitors, with eye tests
for operators;
• working with our suppliers and with anybody else working inside the
facility for any reason, so that safety is not just a company procedure,
but a natural and systematic approach to all activities;
• setting up suitable training activities to ensure that everyone in the
company, in conformity with his/her duties and responsibilities, is
suitably trained to carry them out in a safe way, both for him/herself
and for anyone else who may be involved.

9.6 Product realization


9.6.1 Planning of product realization
COELME product realization is planned and developed through a
sequence of activities consisting in checking the orders in process, managed with
the specific Databases or MS Excel spreadsheets.
Specifically for quality purposes, product/service realization is described
by documents such as the Manufacturing and Control Plans (MCP), the Quality
Control Plans (QCP), and the Supply Management Plans (SMP).
They furnish a complete overview of realization and control operations
carried out at every stage of the manufacture of a device or a system, from the
receiving of materials and components contracted out through to final testing.
These documents include, amongst others:
• the device's manufacturing flowchart, with descriptions of the main
operations for its manufacture, including packaging and dispatch, with
reference to whatever sheets or instructions are applicable;
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• mechanical and electrical checks, during assembly or during final


testing at the factory or on site, with reference to whatever instructions
and technical drawings are applicable.
An important part of these activities is determining what the significant
impact (real or potential) on the environment and on worker health is, with a view
to assuring their conformity with the Company Policy. The relevant performance
methods, measurement and control are dealt with, along with relevant Plans of
Action that might be required.

9.6.2 Customer-related processes


At COELME, these processes are identified with:
• the sequence of activities and relevant operating methods through
which, in handling business dealings - from taking part in a bid for
tenders to formulating the offer and subsequently handling the order -
the company ascertains whether the Customer's demands are really
likely to be met. A special communication channel is activated to give
the Customer confirmation of feasibility or report non-feasibility, as
determined by the review process. All business problems are gone
through in specific procedures, which describe how economic/financial
and technical aspects are dealt with as well as quality-, environment-
and health-related aspects.
• the system through which COELME deals with and forwards Customer
dissatisfaction reports (Complaints) to people and departments within
the organization and how the organization provides an exhaustive
response.

9.7 Design and development


9.7.1 Organizational setup
The Technical Department, inside which design activities are carried out
for COELME products - medium-, high- and extra high-voltage disconnectors and
earthing switches, and relevant accessories - is divided into two secondary
Departments, each with the skills required to perform its respective duties:
• The Research & Development Department
• The Order Management Department
The Research & Development Department is responsible for designing
new products and for carrying out "substantial" changes on existing products.
The Order Management Department is in charge of preparing the
technical documents required for the manufacture of the so-called "modular"
products (which have already been built in the past) or "custom-designed"
products.
All activities concerning design are described in detail in the specific
procedure, which also features the executive stages of order management.
The procedure contains a description of the operational stages prescribed
by the standard ISO 9001:2000 on the subject of design, which, at COELME, are
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applicable practically just to the Research and Development Department - they


are Planning, Review, Verification, Validation.

9.7.2 Planning
The Design Plan defines and describes the various stages of the design
activity. The following elements are also determined for each of them:
• the person in charge;
• organizational and technical interfaces;
• reference documents;
• expected execution times.
• design results, i.e. what documents and reports are to be issued,
especially those to be kept handy, or to be sent, where necessary, to
the Customer.

9.7.3 Review
The Design Review activity consists in a critical, possibly
interdepartmental analysis carried out in order to check consistency between the
results achieved and preset objectives.
It can go from a full detailed control of the design to a check limited to a
number of particular aspects, such as progress, cost objectives, performance.
At this stage, aspects relating to safety and to the environmental
compatibility of the equipment designed and components used are also
evaluated, also taking into account the cost objectives of the design in question.
The results of the Review are documented in special written records filed
in the design dossier.

9.7.4 Verification
Design verification is "graduated" according to the complexity of the
design, and usually includes:
• verification of "progress": the purpose of which is to check that
progress is made according to the schedule established beforehand in
the Design Plan;
• verification of design soundness: the purpose of which is to make sure
the design papers comply with the basic requirements and data;
• verification of costs: the purpose of which is to evaluate whether they
match the costs estimated in the budget defined for the design;
• verification of safety and environmental compatibility: the purpose of
which is to evaluate compliance with safety and environmental
compatibility requirements of the equipment designed and components
used, which must be in line with the cost objectives of the design in
question.
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The results of these checks are suitably recorded in writing and filed in the
design dossier.

9.7.5 Validation
Design validation is based on the outcome of development and type tests,
performed in house and/or at independent laboratories.
The task of defining validation tests, and rating their results for the
purpose of design soundness, is entrusted to a joint examination conducted by
the Research & Development department in association with the Quality Control
Department.
The design is validated when the scheduled tests give a positive outcome,
once it has been ascertained that the product is in conformity with the regulations
applied and that it can meet the design's basic requirements.

9.7.6 Industrial design engineering


The Design Plan gives company functions involved in the process of
industrial design engineering the task of ensuring that quality requirements are
continually met, and that executive measures are consistent, when switching
from the design stage to the production stage. They perform a preventive action,
which consists in choosing the most opportune manufacturing methods and with
measures regarding production equipment so as to assure production continuity
at a constant level of quality.
A fundamental aspect on which attention is placed regards the matter of
equipment safety and the use of substances that must be handled with due care
to protect the safety of workers, as well as the evaluation of the kind of waste
generated by the production process. To deal with this aspect, the services of the
Environment and Health Manager are called upon.
The engineers responsible for industrial engineering work in close contact
with the designers. They also cooperate with the Quality Control Department and
Purchasing department both for procurement and for preparation of production
and control equipment.

9.7.7 Changes to the design


Engineering changes are handled based on certain requirements, such as:
eliminating problems, technological improvements, market changes,
rationalization made necessary subsequent to proposals/requests from inside or
outside the company, or as a result of "Nonconformities" detected.
Special procedures govern the stream of information to the Technical
Department regarding ascertained "Nonconformities". Said "Nonconformities" are
resolved by implementing suitable corrective action.
"Substantial" changes made to the design are identified, documented and
subjected to review and approval based on the same procedures followed for the
original design.
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9.8 Purchasing
9.8.1 General
The purchasing activity carried out by COELME has the following
objectives:
• To make sure that products/services purchased conform to the
specified requirements (technical quality)
• To make sure that suppliers fulfil obligations set out in the agreements
in terms of agreed deadlines (service quality)
• To make sure that suppliers of services and subcontractors meet the
level of quality required by COELME and fulfil all legal obligations
prescribed for the environment and health of workers.

9.8.2 Supplier assessment


Suppliers are chosen based on whether they are fit to meet the agreement
terms and quality requirements. This suitability is assessed based on their past
record and/or by means of auditing.
The type and extent of the checks is established depending on the product
and on the supplier's potential. Supplier performance is assessed at regular
intervals by analysing indicators (trouble with products received, service quality),
which highlight possible deviations, and pinpoint corrective action is taken at the
supplier's premises when the origin of such deviations is determined.

9.8.3 Purchasing data


Purchasing documents contain information required to clearly define the
products/services being ordered and, where necessary, indicate:
• details of the type or class;
• material requirements, as well as applicable technical literature
(specifications, drawings etc.);
• standards relating to the quality system to be applied when
manufacturing the material;
• before they are issued, purchasing documents are checked and
approved, according to who has been officially appointed.

9.8.4 Verification of purchased product


Where so provided for by the agreement documents, COELME can carry
out checks at the Suppliers' premises. If specified in the agreement, the
Customer is entitled to ascertain that the product purchased conforms to the
stated requirements either at the source or when the product is received.

9.8.5 Environmental and safety aspects


In the event independent suppliers or contractors are involved in any of
the organization's activities with a significant environmental impact or with
implications on health, they will be advised of specific relevant procedures and
requested to apply them.
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9.9 Production
9.9.1 General
Production inside COELME, essentially relating to machining,
welding and assembly, proceeds:
• in conformity with reference documents:
o drawings
o work cycles
o work instructions
o control documentation
o quality control plans
• according to a defined sequence of activities:
o materials/components to be used are checked to make
sure they are available
o reference documents are analysed
o equipment is checked to make sure it is available
o protection and safety equipment is checked to make sure
it is available and efficient for safety purposes
o actual manufacturing
o checking
• in compliance with production equipment maintenance
schedules.
On the subject of environmental and safety management, the head of the
Manufacturing Department is responsible, with input from the other company
functions involved, for determining performance/management procedures for
activities and/or processes that have a potential significant impact on the
environment or pose real or potential risks for workers. In doing so s/he provides
operation control to assure conformity to company policy, and to its objectives
and targets.
Operation control is applied through a series of documents (environmental
and safety management procedures) that govern the activities and/or processes,
which, if not carried out under the prescribed conditions, might result in situations
not in compliance with provisions.
More specifically, following assessments made on the environmental
aspects associated with the facility's activities, specific documents have been
determined for the management of:
• waste;
• atmospheric emissions;
• wastewater drains.
Operation control is also applied to the following activities, with special
focus on the prevention of pollution:
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• use of hazardous substances;


• maintenance of systems for reducing and/or dealing with environmental
aspects;
• all activities that entail employing the services of outside contractors.
At COELME, the possible emergency situations are as follows:
• fire
• spills of oil or other hazardous substances (waste or raw materials);
• gas leaks (methane);
• earthquake;
• mixing of incompatible substances;
specific reference documents have also been defined for the management
of such situations/events.
It is the responsibility of the environmental management system manager
and safety management system manager to ensure that the documents
prescribed for operation control and the management of emergency situations
are brought up to date, changed, and added to where circumstances so dictate,
for instance following:
• changes to products or processes or systems;
• new environmental regulations;
• corrective and/or preventive environmental action affecting the ways in
which certain activities are carried out, possibly subsequent to
accidents with effects on the environment;
• results of audits and/or management reviews.
Through information and training activities, internal communication,
distribution and/or availability of integrated system documents, in the ways
defined by the specific procedures, company personnel are made aware of how
operations governed by operation control and/or emergency management control
must be carried out.

9.9.2 Identification and traceability of product


To identify parts and subassemblies, a method is usually employed that
results in the correlation of the individual batches of parts and components with
the relevant documentation, by means of appropriate handling and positioning,
with the appropriate documents then sent together with the parts.
During the final assembly stage, the product acquires personalized
identification that is unique to the specific order.
If traceability is a requirement specified by COELME and/or the Customer,
COELME can agree to apply a satisfactory system whose extent of application,
or period of time, makes it compatible with the company's own mass production.
Traceability of the COELME product is usually assured starting from the
control tests, assembly and final testing - during which the product is not merely
identified, but personalized so that it is recognized as specific to the Order - and
continuing all the way through to delivery to the Customer.
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For the purpose of traceability, various identification methods may be


used, like writing, punching, stamping, adhesive labels etc..

9.9.3 Preservation of product


Correct performance of activities involved in handling, storing, packaging,
preserving and delivering the products is essential to prevent products being
mixed up, damaged or deteriorating during said operations, as well as to prevent
possible emergency situations and the generation of waste. More specifically,
said operations are managed at COELME according to the following principles:

9.9.3.1 Handling
Suitable handling methods and means are specified to prevent damage or
deterioration.

9.9.3.2 Storage
Warehousing and storage areas are designated, intended to prevent
products being damaged or deteriorating while they are waiting to be used or
delivered. Handling of materials stored in said areas is governed by specific
rules. Given the short turnover times of materials in the warehouse, there is no
need for verification to check their state of preservation. Perishable materials are
handled and their correct use is assured (used before they expire).

9.9.3.3 Packaging
To ensure that requirements are met, product packaging and marking
procedures are defined and checked.
More specifically, devices produced are packed automatically according to
precise work instructions.

9.9.3.4 Preservation
Work instructions regarding packaging also contain instructions for the
products' correct preservation prior to dispatch.

9.9.3.5 Delivery
Assures that products are suitably protected to keep the products' quality
intact until they are delivered.
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9.10 Control of monitoring and measuring devices


Each person in charge of measurement, inspection and testing operations
has the task of:
• ensuring that equipment or instruments s/he is issued with are used
correctly and that only coded, qualified equipment and instruments are
actually used.
• making sure that equipment used for testing, measurement, inspection
and control of parameters relating to the environment and health meets
the accuracy and precision requirements demanded by the
measurements to be taken in accordance with the applicable
regulations and/or technical specifications;
• determining what equipment must be checked at regular intervals.

For the purpose of calibration:


• only equipment designed specifically for checking, measurement,
testing and inspection must be taken into consideration, such as:
equipment for electrical measurements (e.g. voltmeters, ammeters);
mechanical measurements (e.g. gauges, equipment for adjusting
product parts during assembly); electronic measurements. Hence
equipment built for indicating purposes are not contemplated, and not
entered in the production or control process.
• an ID code is established as well as a system of cards on which,
depending on the kind of device or instrument, characteristics, uses,
technical tips, diagrams and tolerances are recorded along with a
schedule for subsequent inspections and calibration;
• cards are correctly handled so that certain events are immediately
evident, such as cyclic deadlines, early recalls (if there are any),
temporary unavailability of equipment undergoing scheduled
inspection, repairs outside the company, replacement;
• suitable rooms are designated and made available, where possible,
where specialized personnel carry out inspections and calibration. Said
personnel are issued with the necessary means and sufficiently
accurate samples, which come with certificates and are subjected to
cyclic checks by authorized bodies;
• instead of performing calibration in house, the services of accredited
laboratories may be employed;
• national reference samples, in the mechanical and electrical field, are
generally sufficient to meet our periodic instrument calibration needs. If
said samples are not available for certain kinds of calibration, the test
procedure and acceptability criteria are documented in detail.
For electronic equipment and/or operating software, specific output data
can be checked against certain physical reference samples or by comparing
them with other electromechanical measuring equipment.
Documents containing the outcome of periodic calibration are usually kept
by the function responsible for the equipment being examined and can be
correlated with them to show that they have actually been checked.
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COELME usually uses measuring equipment and instruments belonging to


the company and managed thereby, ensuring that they are kept in constant
working order.
During manufacture and control (including that relating to the environment
and health), there are a variety of verification opportunities for ensuring that
measurements taken are good.
We can mention, for instance:
• equipment whose level of calibration is set for each series of
measurements based on reference sample-tests;
• instruments that can be quickly checked if there is reasonable doubt;
• preliminary measurements and final measurements, taken one after
the other on the same components/products;
• in-line sample-taking plans, followed by checking of operating
characteristics;
• tests carried out on small batches, which must feature similar
measurement values, within certain ranges;
• checking of self-inspection activities, with measurements repeated.
These conditions enable the company:
• to achieve systematic control over all measurement activities;
• to increase reliability of the measurements taken;
• to narrow down and single out the number of devices/components that
might have been produced while defective or out-of-calibration
measuring equipment was in use.
In the latter case, the consequences associated with the non-calibration of
instruments can be dealt with as a nonconformity.
The acceptability or non-acceptability of said anomalous conditions shall
be determined and, if necessary, checks can then be carried out on products at
the factory or through After-Sales Customer Support - outside the company.
Measurement characteristics of inspection and test equipment are
available for perusal by Customers on request. This also goes for periodic
calibration documentation.

9.11 Measurement, Analyses and Improvement


9.11.1 General
The COELME Integrated Management System provides for a suitable
series of product and process verifications. These verifications are intended to
ascertain the continuous compliance of the product and process with the
predetermined acceptance criteria, and to suitably deal with any nonconformity
situations, as well as to monitor signs indicating deviation, based on which
preventive or improvement action can be launched.
To supplement these product and process verification operations, the
Integrated System provides for a series of activities (backed with relevant
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instruments) intended to complete the informational picture of COELME


performance. Relevant activities in this regard include:
• measurement of Customer satisfaction;
• internal audits (Quality, Environment and Safety);
• performance indices;
• monitoring and measurement of environmental and safety aspects;
• management of nonconformities;
• management of emergencies.

9.11.2 Measurement of Customer satisfaction


COELME considers Customer satisfaction the primary element of its
strategies. Guaranteed customer satisfaction is the essential requirement based
on which strategies and policies are defined both outside and inside the
organization. Hence knowledge of the degree of customer satisfaction is the
starting point for determining levels of service and for steering activities and
strategies focussed on the customer by optimizing service provision and
detecting unsatisfied needs.
In this regard, surveys and measurements are determined and promoted
c/o a given number of customers at regular intervals. Surveys are conducted with
the aid of questionnaires, which are submitted to customers during visits, with
telephone interviews and/or email interviews. The results, which are processed
and evaluated, are disseminated, and where areas of weakness are detected,
support projects are launched to improve perception and to remove any sources
of dissatisfaction.
On a more short-term level, the "Complaint Management" report is used
as the main routine source for gathering information on customer satisfaction and
dissatisfaction - its management is described in a specific procedure.

9.11.3 Internal audits


Planned and programmed internal audits are carried out with the aim of
making sure that activities with an impact on Quality, the Environment and Safety
meet the prescribed conditions, and verifying the effectiveness of the Integrated
System.
An annual plan of internal audits is established based on the importance of
the activities and is approved by the Management.
Audits are carried out by qualified personnel. Results are recorded and
reported to the person in charge of the activity who, should any shortcomings be
brought to light, promptly adopts a plan of action to overcome them.
The Plan of Action ends with the evaluation of the effectiveness of
corrective action taken - said verification is documented.
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9.11.4 Monitoring of processes


Processes are monitored through a series of indicators, determined by the
Managers, by splitting the company's strategic vision into critical success factors
and hence into parameters to be measured. The definition and management
criteria of these indicators are contained in a specific document, and make up the
COELME Performance Measurement System.

9.11.5 Monitoring of product


COELME's manufactured products and activities are monitored by
carrying out checks prescribed at the various stages of the production processes
- said checks are recorded as prescribed by the relevant provisions.

9.11.6 Receiving inspection and testing


They are intended to ensure that none of the incoming products are used
or processed until they have been inspected.
Conformity inspections can be carried out by the supplier (if appointed to
perform testing on the company's behalf) or in the receiving department of
COELME's production facilities.
Inspections are carried out in accordance with the technical and inspection
specifications in force and take into account any testing done at the supplier's
premises.

9.11.7 In-process inspection and testing


In-process inspection operations are usually carried out by means of self-
inspection on the production line, and through them:
• products are checked, tested, inspected and identified according to the
requirements of the MCP and/or QCP production control cycles;
• product conformity is established, with respect to the specified
requirements, by monitoring and checking the production process;
• products are held until required testing and inspection have been
completed, except in the case of products released with reservations;
• nonconforming products are identified and segregated.

9.11.8 Final inspection and testing


Nonconforming products do not usually reach final testing. With reference
to the control plans, defined in the MCP / QCP, finished products are inspected to
see whether they meet the specifications. The results of final inspection and
testing on the defined product are recorded and available for viewing. The
finished product is only dispatched once all inspection activities prescribed in the
QP / MCP / QCP have been completed, and once the relevant inspection and
test data have been evaluated.
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Should tests give a negative result, the 'disposition of nonconforming


products' procedure is applied.

9.11.9 Monitoring and measurement of environmental and safety aspects


The following procedures are established and kept in effect for:
• regularly monitoring and measuring the characteristics of
activities/processes that prove to have a significant impact on the
environment. This includes recording information that will enable the
company to monitor the progress of performance, appropriate
operation controls and conformity to the Facility's objectives and
targets.
• periodically evaluating conformity to applicable environmental laws and
regulations.
Measurement activities are usually entrusted to independent laboratories,
which have their own instruments subjected to calibration and maintenance and
which are authorized to issue records attesting to the fulfilment of these
obligations.
Whenever measurements are carried out with the facility's own
instruments, they shall be subjected to calibration as described in the applicable
internal procedures.
It is the responsibility of the environmental management system manager
to determine parameters for which specific obligations must be fulfilled
(verification of conformity of values measured with those established by the
standard for specific parameters, other compulsory notices etc.). The system
manager must also determine any other parameters that, although not governed
directly by the legislation in force, enable greater control of the facility's
environmental problems for which provision has been made for periodic
measurements according to a specific Plan.
Measurements laid down by the Monitoring Plan are taken under the
supervision of the environmental management system manager. The system
manager, also taking into account the prescribed methods, decides which of
these measurements may be made by functions inside the facility and which
must instead be entrusted to independent laboratories. In the latter case, the
manager indicates the requirements to be specified when defining agreements
with outside suppliers.
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9.12 Disposition of nonconformities


COELME has implemented a system for the management of anomalies,
which considers and deals with all kinds of nonconformities:
• product nonconformities;
• internal nonconformities
o design;
o process:
o system;
• complaints;
• environmental and health-related nonconformities.

9.12.1 Product nonconformity


These are nonconformities concerning the products, whether produced in
house or supplied by an outside source. Responsibilities are defined for
examining nonconforming products as is authority for relevant decisions.
Nonconforming products are examined according to procedure and
classified as follows:
• product with defect (subsequent use of product has limited or zero
repercussions - given a waiver);
• product that must be reworked (the defectiveness of the raw material
must be repaired before it can be used);
• products to be rejected permanently (material must be returned to the
supplier or sent off for scrapping).
Nonconforming products that are repaired or have been given a waiver are
used, though their actual state is recorded. If products have been repaired, an
additional inspection is called for. Information on products given a waiver is only
given to the customer in the event this is provided for by the agreement and/or
the specific procedure.
Data and information relating to nonconformities in the production process
are recorded and reviewed at regular intervals to determine whether corrective
action is required.

9.12.2 Internal nonconformity


These are nonconformities that bring to light the objective operational and
functional inefficiency and ineffectiveness of both design activities and usual
behavioural practice, and of the set of procedures that govern them. Indeed,
even the undiscerning application of the written procedure, when its operational
effectiveness seems questionable, can constitute a process nonconformity and
must therefore be pointed out.
Actions resulting from the issuance of internal nonconformities, devised to
correct them, are indicated in the relevant procedure.
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Data and information relating to internal nonconformities are recorded and


reviewed at regular intervals to determine whether more effective corrective
action is required.
9.12.3 Nonconformity at customer's premises (complaints)
These are nonconformities that are encountered after the product has
been delivered to the Customer.
The anomaly reported by the Customer can have a connotation of a
particularly critical nature both for the Customer in question (e.g. plant downtime,
production stoppages, economic impact etc.) and for COELME (e.g. penalties,
claims for damages, risk of losing Customer etc.). In such cases, the Customer
usually sends COELME an official report (letter, fax, email etc.).
Customer complaints are handled using relevant IT tools, via which:
• the competent person responsible for taking emergency action to solve
the Customer's problem is activated in realtime;
• the progress of said action is monitored;
• a database is created on which periodic assessments can be made
and suitable corrective and improvement measures implemented.

9.12.4 Environmental and health-related nonconformity and management of


emergencies
Such Nonconformities can be of the following kind:
• accident with people injured;
• accident that, according to the associated risks, could have resulted in
people being injured but did not;
• accident with no risks for operators, but with implications for the
environment (unexpected waste, spillage of chemicals, unforeseen
emissions into the atmosphere);
• emergency stoppage of production processes;
• human error;
• measurements with unacceptable values compared to the ones
defined;
• results of environmental verification;
• failure to update legal requirements;
• failure to comply with environmental procedures;
• failure to receive forms;
• new kinds of waste;
• spillage of solvents into sewers.
The most critical and potentially dangerous of the possible environmental
Nonconformity situations are determined beforehand, and rules defined for them
so that emergency situations that might arise can be suitably dealt with.
To deal with such situations, procedures are kept in effect that are devised
to locate and respond to possible accidents and emergency situations (including
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natural disasters), and to prevent environmental impact that might ensue whilst
ensuring that in-house personnel are unhurt.
If an emergency situation is encountered, once it is over the effectiveness
of the procedures used is analysed and, where necessary, they are amended.
A programme of practice drills is scheduled yearly to verify procedures
defined for dealing with emergencies.

9.12.5 Analysis of data


As part of their duties, the Area or System Managers determine which
measures relating to the activities and to the products are subjected to periodic
monitoring.
The significant indicators relating to business and manufacturing
processes, and to products and customers, are analyzed by the facility
management and management for that country, whilst environmental and
occupational health-related indicators are analyzed at a facility level only. Targets
and possible improvement action and/or action bringing change are determined
based on these analyses and assessments.

9.12.6 Improvement
9.12.6.1 General
Continual improvement is covered by one of COELME's main processes,
and is based on the critical analysis of data collected on:
• Customer satisfaction;
• overall company performance;
• performance regarding the environment and occupational health in the
production facilities.
This analysis leads to the determination and development of improvement
opportunities affecting:
• product;
• business, manufacturing and logistical processes;
• resources (human, materials);
• organization:
• environmental impact;
• occupational health.

9.12.6.2 Corrective and preventive action relating to quality


These are the main instruments through which, at COELME, the company
develops improvement opportunities brought to light by performance monitoring
and other analysis methods.
The use of said instruments is governed by a specific procedure, which
essentially consists in the following stages:
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• Locating the causes of product, process or System nonconformities


and developing corrective action to remove them, recording the results
of analyses;
• Analysing the processes, operating methods, records relating to quality
and environmental management, occupational health and customer
complains to locate and eliminate the potential causes of
nonconformity (preventive action);
• Submitting final corrective and preventive action to the Management for
examination during the periodic review so that results can be validated
and verified;
• Taking suitable corrective and preventive action proportioned to the
risks;
• Carrying out verifications to make sure corrective and preventive action
is actually taken and proves effective;
• Putting into effect and documenting changes brought about by
corrective and preventive action, especially as far as adaptation of the
Integrated System procedures is concerned.

9.12.6.3 Corrective and preventive action relating to the environment


and health: accident, injury and potential hazard report.
Nonconformities, corrective and preventive action, managed in accordance with a
written procedure, involve widespread reporting and recording of nonconformities and
controlled management of the removal of nonconforming situations, where possible, or
the implementation of corrective action where this is deemed necessary.
Corrective or preventive action is implemented based on the evaluation of the
seriousness of events or of the risk of potential nonconformities linked to situations
encountered in the facility.
The nonconformities considered concern: the management system, the
application of safety and environmental procedures and directives at all levels, deviation
from planned control conditions, emergency situations.
Nonconformities are evaluated during the management review. All deviations from
established practice that are detected are recorded by the personnel on the accident,
injury and potential hazard report, whether it is an event that has actually happened or
whether it is a potential risk situation. The following details are also recorded in the report
document: the time of the event, data identifying the place where the event occurred, the
dynamics of the event or description of the risk situation, what damage (if any) was
caused, remarks, distribution list.
In the event of injury, an analysis of the root causes is conducted jointly by the
head of the department and the OSRMD Manager - the resulting actions are formally
recorded. The OSRMD Manager gathers together all comments and proposals on the
event, prepares and distributes the examination report and notifies the head of the
department of what corrective or preventive action needs developing. Again it is the
OSRMD Manager who periodically monitors the progress of planned action, and once
they have been brought to completion, verifies the effectiveness of measures adopted
and whether procedures have actually been amended, where necessary.
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10 Correspondence between first-level procedures and ISO 9001:2000 - ISO 14001:1996 with first-level procedures
With reference to the schematic representations introduced and featured below, the table shows the correspondence between
clauses of the standards ISO 9001:2000 – ISO 14001:1996 and the first-level procedures of the integrated company management system.

Colour Key

Specific Procedure Not Available

Integrated Quality
Environmental
Quality Safety Manual
&
MQAS
NIC Q NIC A
Environment

Quality Environment
Quality
NIC Q
First-Level
Environment
Safety
NIC A - NIC S Procedures
Quality Environment COELME Internal Procedures
& & Quality - Environment - Safety
Safety Safety

Work Instructions
NIC S Detailed
Procedures
Safety

System Product
Quality, Environmental and Safety Manual
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ISO 9001:2000 ISO 14001:1996


ISO ISO
NIC Procedure Q Title NIC Procedure A Title
9001 14001
Introduction Introduction

General 0.1
Process approach 0.2
Relationship with ISO 9004 0.3
Compatibility with other management systems 0.4
Scope 1 1 Scope

General 1.1
Application 1.2
Normative references 2 2 Normative references

Terms and definitions 3 3 Definitions

Quality management system 4 4 Environmental management system requirements

General requirements 4.1 4.1 General requirements

Documentation requirements 4.2


General 4.2.1
MQAS Quality manual 4.2.2 4.4.4 Environmental management system documentation

NIC Q 423 Control of documents 4.2.3 4.4.5 Document control

NIC Q 424 Control of quality records 4.2.4 4.5.3 Records

Management responsibility 5 4.4.1 Structure and responsibility


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ISO 9001:2000 ISO 14001:1996


ISO ISO
NIC Procedure Q Title NIC Procedure A Title
9001 14001
Management commitment 5.1 4.2 Environmental policy

4.4.1 Structure and responsibility

Customer focus 5.2 NIC A 431 4.3.1 Environmental aspects

NIC A 432 4.3.2 Legal and other requirements

Quality policy 5.3 4.2 Environmental policy

Planning 5.4 4.3 Planning

Quality objectives 5.4.1 4.3.3 Objectives and targets

Quality management system planning 5.4.2 4.3.4 Environmental management programme(s)

Responsibility, authority and communication 5.5 4.1 General requirements

Responsibility and authority 5.5.1 4.4.1 Structure and responsibility

Management representative 5.5.2


Internal communication 5.5.3 NIC A 443 4.4.3 Communication

NIC Q 560 Management review 5.6 4.6 Management review

General 5.6.1
Review inputs 5.6.2 4.3.3 Objectives and targets

Review outputs 5.6.3


Resource management 6 4.4.1 Structure and responsibility

Provision of resources 6.1


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ISO 9001:2000 ISO 14001:1996


ISO ISO
NIC Procedure Q Title NIC Procedure A Title
9001 14001
Human resources 6.2
General 6.2.1
NIC Q 622 Competence, awareness and training 6.2.2 4.4.2 Training, awareness and competence

Infrastructure 6.3 4.4.1 Structure and responsibility

Work environment 6.4


Product realization 7 4.4 Implementation and operation

4.4.6 Operation control

NIC Q 720 Planning of product realization 7.1 4.4.6 Operation control

Customer-related processes 7.2


NIC Q 721 Determination of requirements related to the product 7.2.1 4.3.1 Environmental aspects

4.3.2 Legal and other requirements

4.4.6 Operation control

Review of requirements related to the product 7.2.2 4.4.6 Operation control

4.3.1 Environmental aspects

Customer communication 7.2.3 4.4.3 Communication

NIC Q 730 Design and development 7.3 4.4.6 Operation control

Design and development planning 7.3.1


Design and development inputs 7.3.2
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ISO 9001:2000 ISO 14001:1996


ISO ISO
NIC Procedure Q Title NIC Procedure A Title
9001 14001
Design and development outputs 7.3.3
Design and development review 7.3.4
Design and development verification 7.3.5
Design and development validation 7.3.6

Control of design and development changes 7.3.7

NIC Q 740 Purchasing 7.4 4.4.6 Operation control (supplier control)

Purchasing process 7.4.1


Purchasing information 7.4.2
Verification of purchased products 7.4.3
NIC Q 750 Production and service provision 7.5 NIC A 446 Operation control

Control of production and service provision 7.5.1

Validation of processes for production and service


provision
7.5.2

Identification and traceability 7.5.3


Customer property 7.5.4
Preservation of product 7.5.5

NIC Q 760 Control of monitoring and measuring devices 7.6 NIC A 451 4.5.1 Monitoring and measurement
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ISO 9001:2000 ISO 14001:1996


ISO ISO
NIC Procedure Q Title NIC Procedure A Title
9001 14001
Measurement, analyses and improvement 8 4.5 Checking and corrective action

General 8.1 NIC A 451 4.5.1 Monitoring and measurement

Monitoring and measurement 8.2


NIC Q 821 Customer satisfaction 8.2.1
NIC Q 822 Internal audit 8.2.2 4.5.4 Environmental management system audit

Monitoring and measurement of processes 8.2.3 NIC A 451 4.5.1 Monitoring and measurement

Monitoring and measurement of product 8.2.4


NIC Q 830 Control of nonconforming product 8.3 4.5.2 Non-conformance, corrective and preventive action

NIC A 447 4.4.7 Emergency preparedness and response

Analysis of data 8.4 4.5.1 Monitoring and measurement

Improvement 8.5 4.2 Environmental policy

Continual improvement 8.5.1 4.3.4 Environmental management programme(s)

NIC Q 852 Corrective action 8.5.2 4.5.2 Non-conformance, corrective and preventive action

Preventive action 8.5.3

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