Capitolo 1 Chero - Chero Piping · CHERO PIPING S.p.A. works. In this manual all the activities...

Il presente Manuale della Qualità è di proprietà della CHERO PIPING S.P.A. Non può essere riprodotto,

seppur parzialmente, senza autorizzazione scritta della Direzione.

Head Office: Località Pradaglie,

29013 Carpaneto Piacentino (PC) Tel. 0523/859997 Fax. 0523/850833

e.mail: [email protected]

Sales Office: Via Pacini, 93 20131 Milano

Tel. 02/2664058 Fax. 02/70601557

e.mail: [email protected]

Quality Manual

Revision N° 04 of 21/11/2012

Reference Standards:

UNI EN ISO 9001 Ed. 2008

Direttiva 97/23/CE

Copy N° _____ assigned to: __________________

QUALITY MANUAL Chapter

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Aim and Field of Application Revision

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CHERO PIPING S.p.A. – Località Pradaglie, 29013 Carpaneto Piacentino (PC)

Title: Aim and Field of Application 1.1 Aim 1.2 Company introduction 1.3 Field of Application 1.4 Exclusions 1/46


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1.1 Aim The aim of this chapter is to describe the Quality Programme implemented at CHERO PIPING S.p.A.. 1.2 Company introduction CHERO PIPING S.p.A. is an engineering company specialized in chemical and petrochemical sectors. It has its own know-how and is able to provide a complete service for any kind of problem relevant to the specific industrial sector. Thanks to the cooperation with the companies of CHERO Group: CHERO PIPING S.p.A., LCM S.p.A., D-KTC S.r.l. and CHERO FRANCE (associated firms, ISO 9001 certified), it solves complex industrial problems starting from base engineering, continuing with detail engineering, until arriving to plant construction and starting. 1.3 Field of application The present Quality Manual was drawn up in compliance with the Standard UNI EN ISO 9001, edition 2008 and is applied for the industrial activities of:

ISO 9001:2008: DESIGN AND MANUFACTURING OF SELF-REINFORCING BRANCH OUTLETS AND PRODUCTION OF FORGED, THREADED AND SOCKET FITTINGS TO BE WELDED, FLANGES, NUTS AND BOLTS, NUTS FOR TIE RODS AND RING JOINTS FOR FLANGES IN STAINLESS ALLOY CARBON STEEL, DUPLEX AND SUPERDUPLEX STEEL AND Ni-Cu ALLOYS. TRADING OF COMPONENTS AND TOOLS FOR

PIPING.

97/23/CE DIRECTIVE: CERTIFICATION OF MATERIALS ACCORDING TO 4.3 OF THE ANNEX I OF THE DIRECTIVE 97/23/CE (PED)

1.4 Exclusions In the Management Programme of the Quality System of CHERO PIPING S.p.A. all the requirements of reference regulations are applicable.

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Title: Normative references 2.1 Aim 2.2 References

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2.1 Aim The aim of this chapter is to define the standards, laws and regulations considered by CHERO PIPING S.p.A. for the implementation of the Quality Management System. 2.2 References • UNI EN ISO 9001:2008

Quality Management Systems – Requirements.

• ISO 9000:2005 Quality Management Systems – Fundamental notions and Terminologies.

• ISO 9004:2000

Quality Management Systems – Guidelines for Performance Improvements. • UNI 19001 - ed. 2003

General criteria for the inspections of quality systems, supervisory activity. • Directive 93/27/CE – PED Directive

• Legislative Decree 81:2008 • Acronyms: consult Chapter 3 of this Quality Manual

The technical standards UNI, DIN, ASME e PED are acknowledged by the Company for product manufacturing. All the standards, laws and regulations, together with customers’ specifications and/or procedures of the certification body, are managed according to what mentioned under chapter 04 of this manual. The chapter defines the conditions, the responsibilities and the frequency of control of the documents of external origin.

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Title: Terms and Definitions 3.1 Aim 3.2. Acronyms 5/46


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3.1 Aim The aim of the present chapter is to describe the terminology used in this Quality Manual. 3.2 Acronyms GM ⇒ General Management

QAM ⇒ Quality Assurance Manager

SE ⇒ Sales Executive

SD ⇒ Sales Department

TD ⇒ Technical Department

PM ⇒ Purchase Manager

PD ⇒ Purchasing Department

CAO ⇒ Chief Administrative Officer

ROM ⇒ Responsible for Order Management

NC ⇒ Non-Compliance

CA ⇒ Corrective Action

PA ⇒ Preventive Action

TrD ⇒ Transport Document

Company ⇒ CHERO PIPING S.p.A.

QM ⇒ Quality Manual

OP ⇒ Operating Procedure

OI ⇒ Operating Instruction

Form ⇒ Form The terminology relevant to the Quality System of the Company is in compliance with what prescribed by the standard UNI EN ISO 9000 Ed. 2005.

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Title: Quality Management System 4.1 Aim 4.2 General Requirements 4.3 Quality System Documents 4.4 Control of records 7/46


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4.1 Aim The aim of the present chapter is to establish the quality management system at CHERO PIPING S.p.A. and describe the methods used for managing the relevant documents. 4.2 General Requirements The Quality System Programme documented in this Manual describes the quality policies, the organization structure, the tasks and responsibilities of the various Persons Responsible involved, the procedures, the systems and methods through which CHERO PIPING S.p.A. meets the requirements of Customers and the reference regulations for all the activities that affect product quality. This Manual must be considered as the most important base to ensure the development and the application of the Quality System Programme and the compliance with the applicable regulations. 4.2.1 Primary Processes of the Quality Management System The Company identified (see Annex A) the primary processes, together with the relevant sequence and interaction, for the Quality System and the processes relevant to the development of Commercial, Productive, Technical and Supplying phases (inclusive of the Manufacturing phase). Every primary process is supported by special procedures, or by the chapters of this Quality Manual, that define the implementation methods with the relevant responsibilities. The General Management of CHERO PIPING S.p.A. ensures the availability of resources, both technical and human, in order to support the working and monitoring of these processes. Besides, the General Management identified suitable indicators for monitoring, measuring and analyzing the processes identified (see Annex B). The Company provides the monitoring of the processes carried out externally (thermal treatments). These processes are carried out/monitored through:

Suitable information for product/service supply; Controls of the product/service supplied.

The documents of the Quality Management System of CHERO PIPING S.p.A. include:

Documented declaration about the Quality Policy and its aims (consult chapter 5 of this Quality Manual); Quality Manual; Operating Procedures; Documents necessary in order to ensure an effective planning, working and control of the processes; Recording documents; PED Documents (Directive 97/23/CE).

All obsolete documents, filed because of legal/contract knowledge, are identified by the message “OUTDATED DOCUMENT”. 8/46


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4.2.2 Quality Manual

The Quality Manual formalizes the general Quality System of the company and describes in detail how CHERO PIPING S.p.A. works. In this manual all the activities that intervene in a production cycle are described, therefore the Quality Manual is a cultural legacy for the company. It is a key document for the continuous evolution of CHERO PIPING S.p.A., as it is an essential text for the training of the new employed staff. Besides, the Quality Manual is a document that can be used for introducing the company to real or potential customers. The official language of the Quality Manual is Italian (the company will provide as soon as possible a bilingual copy of the manual, Italian-English, in order to satisfy foreign customers’ needs). The system of section identification reflects the system of the standard UNI EN ISO 9001:2008. The QAM is the drafter of the Quality Manual. In addition to what previously mentioned, the QAM has the following tasks:

design and draw up the Quality Manual according to what prescribed by the reference regulation and the Company Quality Policy;

update the above mentioned Manual so that it reflects the evolution of the company; give the Manual to all the company functions involved; manage the external distribution and the filing of the Quality Manual and its annexed documents.

The GM is responsible for the approval of the Quality Manual. The validity of the Quality Manual is attested by the signatures of the QAM for its issue and the GM for its approval on the first page of every Chapter. The modification of just one page determines the reissue of all the Chapter. The changes made in the Quality Manual by the QAM are always approved by the GM. The new revision date is written on all the pages of the modified Chapter and on the updating table. The text modified is highlighted in cursive characters + side bar on the margin. Controlled and numbered copies of the Quality Manual are distributed to:

Copy N° 1 Certification Body; Copy N° 2 Milano (technical and sales departments); Copy N° 3 Carpaneto Piacentino (Production / Warehouse / Shipment / Quality Control).

Subsequent changes are distributed, by the QAM, to the same bodies/departments foreseen in the distribution list. It is up to the receiver to update the copy in his possession and eliminate the obsolete one. All the copies of the Quality Manual distributed in an uncontrolled way are identified by the QAM through a “Uncontrolled Copy” stamp. Every time a chapter is modified, the updating table is updated and distributed to all the owners of a copy of the Quality Manual with the section modified.

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Procedures The operating procedures (OP) are documents that supplement the Quality Manual and describe and determine the operating modes necessary to carry out the operations linked to activities that affect the quality, by ensuring a continuous and suitable control. These procedures describe the executive modes of the various activities involved in the Quality System, identify in detail the functions and/or the staff to which the tasks are entrusted, specify the supporting documents that are used for ensuring the quality inside the company.

Forms

All the forms prepared by CHERO PIPING S.p.A. are used for recording the quality level reached in connection with the performances obtained by the different activities of the company Quality System. All the forms are prepared by the company functions that need a new form for the checking or the recording of their activity. All the forms are identified by the initials Mod. T.X.Y.Z., where

Mod.: Form; T: Table; X: reference chapter of the quality manual; Y: reference paragraph; Z: progressive numbering.

The forms bought externally are identified by the coding given to the form by the printer. The QAM keeps updated the list of the forms used by the company containing the state of revision of each of them (issue and revision date) and the list of distribution. The form is considered as approved by the GM when it is included in the form list.

4.2.3 Control of the documents

The Quality Assurance is responsible for the issue, the distribution and the revision of the procedures necessary to create and document the Quality System (procedures of Quality Assurance). These procedures must be drawn up by the Quality Assurance once questioned the functions involved, that will verify their contents after the definitive drawing up. The Quality Assurance issues the procedures only after the approval of the General Management. The QAM is the drafter of the Operating Procedures who, when necessary, makes use of the company bodies involved. All the OP are approved by the GM before their issue. The Operating Procedures are identified by the initials PO.X.Y.Z., where

PO: Operating Procedures; X: Reference chapter of the quality manual; Y: Paragraph; Z: Progressive numbering.

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The changes in the OP are made by the QAM and always approved by the GM. The new revision date is written on the first page of the modified OP and on the updating table. The text modified is highlighted in cursive characters and by a side bar. The OP are distributed through controlled copies to the external and internal functions foreseen in the distribution form (Form 4.2.0 List of System Documents) and included in electronic format in viewing version only inside the company server Y:\DOCUMENTI ISO 9001 Ed. 2008. Subsequent modifications are distributed, by the QAM, to the same bodies/departments foreseen in the distribution list (Form 4.2.0 List of System Documents) and updated in the special directory in the company server. It is up to the receiver to update the copy in his possession and eliminate the obsolete one. All the copies of the OP distributed in an uncontrolled way, are identified, by the QAM, through a “Uncontrolled Copy” stamp. Every time a OP is modified, the updating table (Form 4.2.0 List of System Documents) is updated.

The minimum identification elements of the procedure are the following: On the first page: a) title b) identification (numerical, alphabetic or alphanumeric) c) number of the copy (filled in at the moment of the distribution) d) revision matrix (title block at the bottom of the page that shows: revision state, name and signature of the drafter, name and signature of the person who carries out the control, name and signature of the person who approves, date of issue) e) number of the page referred to the total number of pages. As regards the following pages: they are at least identified by the elements described in b+g+h or in a+b The procedures are drawn up on a A4 headed sheet (or showing the Company Logo), on the pattern of the present sheet, except for the variations previously agreed with the Quality Assurance.

Documents of External Origin

The documents of external origin are: standards; laws; Community Directives; etc.

These documents are managed in order to avoid to loose or damage them and to ensure the use of their latest version.

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All the external documents are recorded in a special register (Form 4.2.2 Register of External Documents). This register allows to make the management of these documents easier. The management of external documents is entrusted to the information officer.

Customer’s documents

Customer’s documents are:

customers’ drawings; customers’ specifications; contract documents.

These documents too are managed in order to avoid to loose or damage them and to ensure the use of their latest version. They are filed in paper copies inside the customer’s order printed by the sales department and in electronic copy inside the company server in the path created for every customer. Their management and updating is under the responsibility of the Sales Department. All the documents having external origin are verified and approved before they are distributed in the company, by special competent functions, in order to determine their adequacy.

4.2.4 Control of Records The records are arranged and kept for attesting the conformity to the requirements and the effective working of the quality management system. Precautions have been taken to keep the records readable, identifiable and easily findable during their filing period. The special form (Form 4.2.1 List of Recording Documents) shows:

identification methods; filing methods; protection and traceableness methods; time and person responsible for their filing; elimination methods.

All data processing positions are protected by passwords and antivirus programs. The back up of the company server is carried out daily. The disks are kept in safe places in order to preserve their content. The access to data is allowed to the employees or the authorized visitors only. All data are easily findable and consultable through the list of Quality Data. Every employee has free access to the data necessary to carry out the working activity. All data are kept in order to avoid to damage or loose them. The data may be kept in files, containers or in other ways according to company needs. When required by the contract or the specifications, CHERO PIPING S.p.A. can send the data to customers or allow their consultation at the company. The data no longer necessary or the ones that exceeded the foreseen filing period may be destroyed and the person responsible for this operation is indicated in the special form (Form 4.2.1 List of Recording Documents).

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Title: Management Responsibility 5.1 Aim 5.2 Management engagement 5.3 Quality policy 5.4 Quality aims 5.5 Planning of Quality Management System 5.6 Responsibility and Authority 5.7 Management representative 5.8 Internal communications 5.9 Management review 13/46


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The aim of this section is to describe the Quality Programme that CHERO PIPING S.p.A. wants to implement. This programme is applied to all company activities under contractual situations or not. 5.1 Management engagement The present manual documents the Quality System of CHERO PIPING S.p.A., having its registered office in Pradaglie di Carpaneto Piacentino (PC). It is applied to all the activities described under chapter 1 of this Quality Manual. The prescriptions contained in this manual have been determined in compliance with the standard UNI EN ISO 9001:2008 about external quality assurance. Every person identified in this manual is responsible, as regards the implementation of what foreseen by it, for the area in their jurisdiction. The Person Responsible for the Quality Assurance Service (appointed as Management Representative) has the necessary organizational autonomy, authority and responsibility for:

identifying the problems that affect quality; reporting the problems to the managers by suggesting possible corrective actions; checking that the corrective actions undertaken are carried out and efficacious; checking the present manual and the relevant procedures.

Besides, he has the necessary authority and responsibility for correcting the Quality System and applying all the procedures foreseen in this manual. One of his specific task is to keep the Management informed about the state and the adequacy of the Quality System and the real application of what foreseen in the present manual. The Management has the responsibility to ask for the complete application of the present manual, that it declares to approve entirely by signing on the indexes present in this chapter and declaring to carry out, at least once a year, a documented control on the state of the Quality System and its adequacy by preparing possible corrective/preventive actions. Besides, it is up to the Management to find a solution to possible disagreements between the organizational structures mentioned above.

The General Management

...................... ……………………………

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5.2 Customer satisfaction The primaty aim of CHERO PIPING S.p.A. is to manufacture products and supply services that satisfy its customers' needs completely. In particular, the Company considers as essential the following combination:

Provide to its Customers reliable products/services in compliance with order specifications.

Support the Customer in choosing the most suitable product and supply a service such as to satisfy the Customer, not only with the quality of the products supplied but also with the professionalism and the service offered by the Company. To reach these goals, the Company declares the following engagements: 1. Maintain a documented Quality System, in compliance with the reference standard (UNI EN ISO 9001:2008 and

Directive 93/27/CE - PED), that prioritizes the control of the production cycle, as well as the relationship with the Customer, with a particular attention to the aspects concerning the transmission of the information necessary to design and manufacture the product;

2. Review, at prearranged intervals, the Quality Management System according to new company aims/market

needs; 3. Manufacture products in compliance with the applicable regulations/specifications; 4. Manufacture products in compliance with Customer specifications; 5. Ensure the reliability of the products thanks to suitable tests, inspections and testing.

5.3 Quality Policy (Annex “A” to this chapter)

The Management assures that the Quality Policy is understood at all levels through:

training, instructive and/or informative courses, aimed at the study of the QM and the OP; identification and acquisition of technologies, equipments, procedures, resources and capacities necessary

for obtaining the quality required; carrying out of periodical internal inspections on the Quality System supported by the implementation of

possible corrective or preventive actions aimed at a continuous improvement of the Company Quality; check of the effectiveness of the corrective or preventive actions carried out.

5.4 Planning Our vision of the CONCEPT OF QUALITY is not only connected to product features but precisely to the pair PRODUCT/USER.

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The aim of CHERO PIPING S.p.A. concerning quality is to provide products that satisfy, under all points of view, the needs of our Customers. The quality of any industrial product is certainly influenced by all its physical, functional, aesthetic characteristics; the knowledge and study of them and the possibility to use the most advanced technologies, typical of our sector, represent the precise engagement towards which the whole management of the company is directed. Always focusing our attention towards the pair product/user, we consider the QUALITY as THE DEGREE OF SATISFACTION RELEVANT TO PRODUCT FEATURES TOWARDS THE NEEDS OF THE CUSTOMER IT IS INTENDED FOR. The quality at CHERO PIPING S.p.A. is ensured starting from order transmission until product delivery. The Management stands surety for the Quality policy to be completely understood by all the staff. Therefore, some training courses for new employees are held and information and specific courses relevant to the Quality Systems are available for all the staff of CHERO PIPING S.p.A.. The most suitable method for quality management is always determined during every meeting for the re-examination of company policies. 5.4.1 Aims for Quality In addition to what mentioned in the previous paragraph, the General Management plans, for every single company process, some aims for Quality (consult annex C to the chapter 4 of this Quality Manual). When possible, these aims are established in order to be measurable and consistent with the Quality Policy of the Company. 5.4.2 Planning of the Quality Management System The General Management of CHERO PIPING S.p.A. established a Quality Management System such as to satisfy:

customers' requirements; the general aims of CHERO PIPING S.p.A..

On this purpose, the General Management undertakes to provide all the resources (both technical and human) suitable for the reaching of the prearranged goals. Possible changes made in the Quality System are approved, by the General Management, in order to verify that these changes are not in conflict with the Company Policy. 5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority Authority and functional ties are defined by the organization chart enclosed to this chapter (Organizational Chart Rev. 0). The authority, as regards the definition of the Quality System structure and every necessary adjustment or variation, belongs to the Management and to the Legal Representatives. The responsibility for the application of what foreseen in the present manual belongs to the persons in charge of the various bodies for the part of their competence. Besides, these same persons are responsible, together with the Quality Assurance System Manager, for the review and adjustment of the procedures, forms and documents usually drawn up in the area under their direct jurisdiction. 16/46


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The persons in charge of the various bodies are authorized to delegate suitably qualified staff to a part of their tasks but the relevant responsibility can’t be subject to delegation. These same persons can carry out tasks assigned to their employees and assume the relevant responsibility, provided they are suitably qualified. The fundamental responsibilities of the bodies present in the organizational chart enclosed , with a particular reference to the activities that affect product/service quality, are described in the relevant "Staff Files" (Form 6.2.1 Rev. 0). 5.5.2 Management representative The General Management delegates and allows full power to the Factory Manager for the tasks ascribed to him in the present Manual and for what required by the standard UNI EN ISO 9001:2008. It is up the Factory Manager to:

Ensure that the processes necessary for the quality management system are planned, carried out and keep updated;

Report to the General Management the performances of the Quality System and every need for improvement;

Ensure the consciousness promotion of Customer’s requirements within the Company. 5.5.3 Internal communications Special processes are at the base of internal communications. The ways for letting the data about System effectiveness known within the organization include:

meetings between departments and Management Management review free distribution of the minutes of all the meetings internal audit closing meetings other usual ways of company communication.

5.6 Management review 5.6.1 General The General Management, in collaboration with various persons responsible of company functions, promotes and carries out yearly a review of the Quality System. 5.6.2 Review Incoming Elements The Review of the Management will deal with the following subjects:

Customers’ reactions Process performances and product conformity 17/46


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Company Quality data Practical preventive and corrective actions Actions deriving from previous reviews Planned variations that can affect the Quality Management System Suggestions for further improvements

Results, conclusions and recommendations are documented in order to make the possible preventive and/or corrective actions operative. During these activities, new policies/company aims will be determined (when possible, these goals are expressed in a measurable way and the needs of technological, human and economic resources for their reaching will be determined). The carrying out of possible preventive and/or corrective actions will be ensured by the various persons responsible and verified by the Quality Service Manager. 5.6.3 Review Outcoming Elements During the meetings dedicated to the review, the Management will establish the suitable actions to undertake in the following fields:

Improvement of the effectiveness of the System and its processes Product improvement, according to customers’ needs Need for further resources

The responsibility of the various interventions required is entitled to various persons responsible. All the decisions taken during the meetings, the interventions assigned and the relevant expiry dates have to be registered in the relevant minutes.

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6. Management of resources 6.1 Resources available The scope of the present chapter is to describe the programme carried out by CHERO PIPING S.p.A. for the management of resources:

Human resources; Facilities; Working environment.

6.2 Human resources

6.2.1 General

In order to ensure our staff’s skills, we prepared precise descriptions of its various tasks, in order to identify the qualifications required for every position that affect product quality. These qualifications, inclusive of the requirements concerning training, practical skills and experience, together with the required training period, provide the indispensable skill for every position of the operative cycle. The Staff Management records the qualifications of the whole staff. When some differences are found between an employee’s qualifications and the requirements of the job he was assigned to, the competent Management asks, when necessary, for a specific training that allows the employee to obtain the necessary skills: the efficacy of the result will be examined at the end of these courses. All the employees are trained according to the pertinence and the importance of the assigned activity, as well as their contribution to the reaching of the goals foreseen. 6.2.2 Skills, Consciousness and Training For every single company function, the relevant competences were identified (Function Matrix – Requirements Form 6.2.0 Rev.0). In the form “Staff file” (Form 6.2.1 Rev.0), are registered all the degrees of skills, education, training and experience gained during the professional activity. The monitoring of the skills is carried out by the General Management for the Persons Responsible for company functions and by these ones for the operators. As regards new employees, this activity is carried out directly during the recruitment phase. Against these monitoring operations, special training sessions can be considered as necessary for satisfying Company requirements. The training activities for the staff of CHERO PIPING S.p.A. are divided in:

informative training: directed to describe the aims and characteristics of the Company Quality System, with reference to the standards applicable, and allow everyone to understand the procedures and proceedings of the Quality System, relevant to the specific working areas.

formative training: directed to develop and complete the professional skills of the staff; the courses or

sessions of formative training can have both a theoretical or practical nature and can include a final qualification exam.

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CHERO PIPING S.p.A. develops training programmes for all the staff having tasks that affect quality. The QAM is responsible for the professional training of the staff. On this purpose, every department/office manager, when necessary, informs the QAM about the need for staff training. These needs may derive from specific requests from the parties concerned or in consequence of new processing techniques, new equipments, interpretation of the Operating Procedures etc. The Quality Manager plans and implements the courses for staff training (when required). The courses can be held by internal teachers or by external bodies specialised in staff training. The training on the job is to be considered as a training course. The staff carrying out tests, checks and testing, in order to verify the compliance of the product with the essential requirements, is qualified or trained for executing in the best way possible what required from it. The QAM coordinates the training of this personnel. In this programme it is important to consider the personal experience acquired during the years or through the carrying out of controls. The QAM has the responsibility to value the training and the experience of the staff in order to determine its qualification. The Internal Inspections are carried out by the personnel that attended a course for the execution of these activities. This course includes what follows:

theoretical indoctrination about the subjects of this activity (UNI 19001); working with personnel experienced in the carrying out of Internal Inspections; practical training about the Internal Inspections carried out by the supervision of skilled staff.

The training for new employees at their first job includes: working shoulder to shoulder, for at least two months, with skilled personnel; theoretical training, internal or external, about the subjects of the activity the new employee will have to carry

out and concerning the tasks to accomplish. For every course attended, the documents used are preserved and the efficiency of the course is valued. All the "Staff files" (Form 6.2.1 Rev.0) are managed and filed by the QAM. 21/46


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The management of resources is carried out according to the following logic diagram:

MANAGEMENT OF HUMAN RESOURCES INPUT FLOW OUTPUT DESCRIPTION

Job applications Curriculum

STAFF RECRUITMENT


To ensure the competence of our staff we prepared precise descriptions of the various tasks, in order to identify the qualifications required for every position that affects product quality.


STAFF ENGAGEMENT

Staff file Individual training

Job descriptions Training request Training programme

STAFF TRAINING Individual training Certificates / diplomas

All the employees are trained according to the pertinence and the importance of the activity assigned, as well as their contribution in reaching the goals foreseen. The training programme, deliberated every year by the Management, is updated according to company needs. The training of each employee is recorded in special training files.

Individual training Appraisal discussion STAFF EVALUATION Appraisal discussion

Appraisal discussion JOB TERMINATION Departure interview

The employees who leave the company are interviewed by the Management with the aim of finding out possible organizational inefficiencies that may influence staff’s satisfaction and motivation.

6.3 Facilities and Working environment CHERO PIPING S.p.A. works in offices of about 150 m2 situated in Via Pacini, 93 – 20131 MILANO, a shed (Chero 1) used for the Production activity of about 2200 m2 and a shed (Chero 2) used as Warehouse of about 2200 m2 situated in Località Pradaglie – 29013 Carpaneto Piacentino (PC).

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The facilities meet the safety requirements and are suitable for the kind of work carried out. The services of material transport are carried out through the aid of truck drivers with proved experience and previously qualified. The softwares used by CHERO PIPING S.p.A. are protected by special antivirus programs. These programs are periodically updated, in order to avoid pollutions deriving from:

Electronic mail; Files delivered on data carriers; Access to websites.

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7. Product manufacturing The aim of the present chapter is to determine the programme carried out by CHERO PIPING S.p.A. relevant to product manufacturing. 7.1 Planning of product manufacturing The company ensures that the product is in compliance with the specified requirements through: ⇒ Quality Manual in compliance with the standard UNI EN ISO 9001:2008 and Directive PED 97/23 CE; ⇒ Operating Procedures in compliance with the Company Quality Manual, the standard UNI EN ISO 9001:2008

and the standards applicable; ⇒ aims for quality and requirements relevant to the product; ⇒ planning of all the activities/processes that affect quality; ⇒ control and monitoring activities, inspections and specific tests for the product and relevant acceptance criteria; ⇒ internal inspections suitable for verifying the effectiveness of the Quality System. The quality is planned through:

the identification and the purchase, when necessary, of new working and control equipments suitable for reaching the prearranged goals;

the use of suitably trained personnel for the carrying out of company activities; the compatibility and the correlation between the production processes and the working and control documents

prepared; the definition of appropriate working and control parameters of the product and production process; the recording and analysis of the data concerning quality and the implementation of corrective and preventive

actions. The above mentioned planning also considers the evolution of applicable standards and laws, the market evolution and the policy/aims of the company. CHERO PIPING S.p.A. prepared a special procedure that describes the methods for managing the component manufacturing orders, and precisely the methods of: ⇒ transmission of order data; ⇒ management of activity progress report; ⇒ management of special processes; ⇒ identification of materials and accessory components (when traded); ⇒ execution of tests, checks and/or testing; ⇒ packing of finished products; ⇒ management of non-compliant products. What mentioned before has been transmitted to all the suppliers of equipments on behalf of CHERO PIPING S.p.A.. The General Management, by means of special targeted plans/programmes, also identifies the need for the acquisition of regulations, processes, production/testing equipments, human resources, control and production techniques and the drawing up of the documents for quality recording. 25/46


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7.2 Processes relevant to Customers 7.2.1 Determination of the requirements relevant to the product A preliminary need compared with the requirements prescribed by the contract is to reach a complete, univocal and appropriate definition of buyer’s requirement; on this purpose, it would be necessary to consider the situation directly with the buyer. Before accepting an order, CHERO PIPING S.p.A. determines customer’s needs, and precisely:

Main request Necessary procedures before and after the delivery Details not established by the customer but absolutely necessary for the specific use of the product, current

or foreseen Legal and regulation requirements of the product Additional requirements determined by CHERO PIPING S.p.A.

The orders can be received in electronic format, by telephone, fax or ordinary mail. When the Sales Departments receives a request for products or services by a customer, even potential, the Person Responsible will identify the requirements and document them appropriately. The information required for the execution of the order are:

Product identification code or service description Quantity Shipment date Special requirements Standards or laws to apply Shipment method Possible customer constraints

All offer requests are assessed not only by the Sales Executive but, in case of complex technical requests from the customer, by the Technical Manager too in order to verify:

⇒ technical feasibility; ⇒ analysis of the technical documents delivered by the buyer; ⇒ definition of the bill of materials; ⇒ determination of the purchase prices of the components included in the bill of materials and equipment

manufacturing; ⇒ determination of components/materials supplying time and equipment manufacturing; ⇒ productive feasibility.

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7.2.2 Review of the requirements relevant to the product The Sales Department reviews the data obtained in order to verify that customer’s requirements have been met and if CHERO PIPING S.p.A. can meet them, proceeding as follows: ⇒ check the possibility to meet customer’s needs; ⇒ plan activities, resources, equipments and staff; ⇒ identify the compulsory requirements relevant to the product; ⇒ foresee the execution time; ⇒ estimate the costs; ⇒ determine the sale price. In case of CHERO PIPING S.p.A. can't meet some of the requirements, the Sales Department will contact the customer in order to try to adapt his needs to the production capacity of CHERO PIPING S.p.A. or communicate the impossibility to provide the product or service required. If CHERO PIPING S.p.A. can meet customer’s requirements, the order is accepted. When a Offer Request is received, the Sales Department prepares and send the Offer, that is always formalized in writing. Should the Offer Request contain important prescriptions relevant to the quality, the drafter submit them to the QAM in order to value their influence. The minimum content of an Offer is the following:

identification number name of Offer receiver and references of the Offer Request object of the Offer together with references to standards or other documents quantity required delivery methods and time foreseen amount and terms of payment validity limits of the Offer (temporal, quantitative, etc.)

Upon order receipt, the Sales Department, with the support of other sections such as the Quality Assurance and the Technical Management, will:

verify the congruence between Order and Offer verify to have all the documents mentioned in the Order and that they are at the state of revision established; verify to have all the technical documents necessary to execute the Order and their applicability considering

their state of revision; ask to the Customer to send the missing documents formalize the acceptance of the Order:

once controlled the positive result of the previous verifications, the Sales Department will formalize the acceptance of the Order by issuing an Order Confirmation 27/46


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The person responsible for the management of Offers and Orders is the Sales Executive. The table here below shows the procedural phases and the relevant responsibilities of the various bodies. Phase Operation Responsibility Collaborator Person Resp. for Doc. filing

1 Offer request analysis (technical aspects) SE SD + TD SD 2 Offer request analysis (commercial aspects) SE SD SD 3 Offer Review and Formulation SE SD + TD SD 4 Order analysis SE SD + TD SD 5 Order Sheet Issue SE TD TD 6 Contract variations (technical aspects) SE SD + TD SD 7 Contract variations (commercial aspects) SE SD SD

SE = Sales Executive, SD = Sales Department, TD= Technical Department

Possible variations or changes made in the Orders already obtained are analyzed through the same methods applied to the activity of the first Review. When necessary, once made the changes, the technical documents of the order are updated. All technical documents delivered by the buyer, as for instance drawings, specifications, etc. are verified upon their receipt by the Technical Manager. The verification considers what follows:

1. Document completeness; 2. Customer’s requests; 3. Possibility of carried out what required by the customer.

Besides what mentioned before, the TM verifies that the document checked does not replace a document already in possession of CHERO PIPING S.p.A. (updating). The evidence of the control of these documents is represented by the receipt date and TM signature. The document checked is filed in the company server in the special directory dedicated to the Customer. Possible obsolete documents, filed for knowledge reasons, are saved in a special directory called “Outdated Documents”. The contract documents are filed and kept according to what prescribed by the Document Matrix of CHERO PIPING S.p.A.. 7.2.3 Communication with the customer The company function that interacts with the buyer is the Sales Department. All the communications concerning orders/job orders on hand or under negotiation are formalized on special forms. The information relevant to products, questions, etc. can be also sent/received through data processing support (electronic mail). Any claim, both technical and operational, received from the customer, is managed in compliance with what prescribed under chapter 8 of this Quality Manual. The information about the products provided by CHERO PIPING S.p.A. are sent to the customer by means of booklets, catalogues, telephone calls or web pages. 28/46


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Every System operative document that will be distributed outside the company must be reviewed and approved in compliance with what foreseen in this Manual under chapter 4. The price lists are not considered as operative documents and are distributed in an uncontrolled way and not in a systematic way to the complete discretion of the commercial agent. The information relevant to sales and marketing are filed in a specific database. The orders are received by the Sales Department. The Sales Executive has the responsibility to inform all the functions involved about the orders obtained. For every new order, a person will be entrusted with the following communication with the customer (information, approvals, etc). All the communication received by the customers must be recorded in a special file. The Sales Executive or the Project Manager who receives a communication from a customer has to immediately undertake all necessary actions in order to satisfy the customer. Should this communication be a claim, it is necessary to issue immediately a request for enquiry and a possible corrective action. Customers' communications, claims included, are processed and analyzed. 7.3 Design

7.3.1 Design and development planning The procedure P730 “Design” describes all the actions to undertake in order to control design and product development. The Technical Department follows this procedure for all the matters concerning:

Research and development phases Project revisions required Special verification and testing methods, suitable for every single phase Responsibilities and decision-making power relevant to research and development Identification of the technical interfaces necessary for the project Updating of project plans as long as the work proceeds

7.3.2 Input for design and development The data relevant to product requirements are determined and documented according to the procedure P730 and reviewed about their adequacy and completeness, in order to avoid any ambiguousness. These data concern:

Functional and efficiency requirements Applicable legal and regulation requirements When possible, information obtained by previous similar projects Further essential requirements for the phases of research and development

7.3.3 Results of design and development The results of design and development are documented according to the procedure P730; they are presented in a way suitable for verifying the data entered and they must be approved before the delivery. These documents must:

Comply with the requirements Provide appropriate information about purchase, production and assistance 29/46


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Contain or refer to customer's acceptance criteria Specify the essential characteristics of the product for its appropriate and safe use

7.3.4 Review of design and development During the design phase, the stages suitable for carrying out a review of the work done are established. These reviews are in compliance with the procedure P730; the results are recorded in the reports or minutes of the meetings held and kept as a document (Form 7.3.4 Rev. 0). The aim of these reviews is to:

Assess the results of research and development activities and determine the complete fulfilment of the results foreseen

Identify any kind of latent problem and suggest the necessary countermeasures Listen to the opinion of the persons who participate in the various phases of research and

development 7.3.5 Verification of design and development

In order to ensure that the results of the Technical Department are in compliance with the initial requirements, a special verification is planned and carried out. The results of this verification, together with the actions undertaken, are recorded and kept according to the procedure P730 by using the special form 7.3.4 Rev. 0.

7.3.6 Validation of research and development

It is carried out according to the original plans, in order to ensure that the product meets completely the requirements relevant to the application foreseen. When possible, the validation must be completed before the delivery and the relevant documents are kept according to the procedure P730 "Design”.

7.3.7 Control of design and development changes

The procedure P730 also specifies what is necessary for identifying, recording, verifying, validating and approving the changes made in the project. The examination of these changes includes an assessment of their effect on the various components and on the finished product. To demonstrate the results of the revision and all the necessary interventions, the relevant minutes are kept.

7.4 Supplying 7.4.1 Supplying process

In order to ensure that the components acquired meet the requirements specified, the purchases are carried out according to the following instructions, that describe the control reserved to the suppliers. These ones are assessed and chosen according to their capacity of supplying products that are in compliance with the requirements described in the procedure, that also contains the criteria on which founding these choices and assessments. The documents relevant to every decision taken about purchases are kept. CHERO PIPING S.p.A. suppliers are divided in three macro categories: 30/46


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⇒ Category 1: suppliers of components/thermal treatments manufacturing/working; ⇒ Category 2: suppliers of technical advices; transport suppliers; ⇒ Category 3: suppliers of packages, various supplying.

The Management carried out an initial choice of Suppliers according to the importance of materials/services, then selected the sources of supply on the basis of the previous experiences and Suppliers' characteristics. Therefore, the Suppliers are qualified as follows: Suppliers of Category 1: ⇒ Historical (suppliers who have been working with CHERO PIPING S.p.A. for a long time and who did never

show negative conditions affecting product/service quality); ⇒ ISO 9000 Certified Company or that can provide Quality Certifications (for ISO 9000 certified suppliers, it is

up to the QAM to verify, every year, the validity of the certificate. In the presence of expiry dates, it is up to the QAM to ask for a copy of the updated certificate);

⇒ Organisational Structure (“Supplier Card” sending); ⇒ Inspection at Supplier’s factory (when necessary) ⇒ Quality/Price ratio; ⇒ Monopoly.

The decision of qualification of a supplier, as regards technical aspects, is up to the QAM. The Economic/Commercial aspect must be valued by the Purchase Manager.

Suppliers of Category 2: ⇒ Historical; ⇒ References; ⇒ Accreditations (equipment calibration laboratories); ⇒ Means of transport available (carrier trucks); ⇒ Professionalism and Skills (consultants and maintenance men); ⇒ Quality/Price ratio.

Suppliers of Category 3: ⇒ the suppliers included in this category do not need any qualification.

The supplying is checked upon receipt.

All the Suppliers included in the categories 1 and 2 must be recorded, after the qualification, in the Form “List of Qualified Suppliers". The suppliers included in the category 3 do not need any recording.

Supplier File The QAM sends or passes on to all the Suppliers of the Category 1 (not ISO 9001 certified) the Form 7.4.0 Supplier File. The document must be returned by them drawn up in all its parts; its function is to inform the QAM and the Purchase Department about all the elements that are indispensable for a correct, clear and complete identification of the supplier. 31/46


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List of Qualified Suppliers The List of Qualified Suppliers (Form 7.4.1 List of Qualified Suppliers) consists of a list of all the suppliers of the categories 1 and 2 considered as suitable for meeting the requirements imposed by CHERO PIPING S.p.A. In this list, the QAM writes the following information: ⇒ supplier’s company name; ⇒ description of the supplying; ⇒ reason of the qualification; ⇒ Supplier Quality Index (year’s review carried out by the QAM).

In case of, once carried out the year’s review, a supplier is cancelled from the list of qualified suppliers, the QAM issues again the updated List of Qualified Suppliers. New Suppliers In case of there’s the need or the advantage of buying materials belonging to the categories 1 and 2 from new suppliers, that are not included in the List of Qualified Suppliers (Form 7.4.1 List of Qualified Suppliers), before issuing the purchase order the Purchase Manager will arrange for having them qualified by the QAM. Only once the new Supplier has been qualified and classified, the Purchase Manager can issue the purchase order. In case of urgency, the above mentioned activity can be bypassed. It is up to the Purchase Manager to inform the QAM about the issue of an order to a not qualified supplier (it is sufficient by e-mail). The QAM will verify the material or have it verified by the suppliers manufacturers of the equipment. The positive result of all the controls qualifies the supplier automatically. Anyway, the QAM will have to ask for the documents foreseen under the paragraph “Selection of Suppliers”. Supplier Quality Index The Quality Manager controls the reliability of the qualified suppliers. Once completed the controls upon goods receipt, the Quality Manager records the result of the control on the transport document. In addition to the recording of the control on the incoming goods, the inspection is also carried out through the analysis of the NC and the service performances. The result of the above mentioned control is recorded in the supplier list (by writing in the control column the letter “Q” qualified or “NQ” not qualified) and in the management review. According to the above mentioned data, the Quality Manager check the reliability of the supplier as regards the quality of the supplying and the Quality of the terms of delivery and decides his requalification.

7.4.2 Information about supply

The purchase orders are issued according to management criteria and/or Customer orders. The supply needs are communicated, verbally, to the Purchase Department.

The purchase orders are issued to the suppliers previously qualified by the QAM. As regards the purchase of materials for the manufacturing of PED equipments, only UNI EN ISO 9001 qualified suppliers are contacted. Otherwise, some mechanical tests on the material bought will have to be carried out by an accredited laboratory. 32/46


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The purchase order is issued by the PD and approved by the PM. This order contains all the following information: ⇒ Supplier’s Company Name; ⇒ N° of the Purchase Order and issue date; ⇒ Product description and relevant quantity; ⇒ Terms of delivery. When necessary, or in case of occasional suppliers, the price and the conditions of payment and transport are also recorded. As regards the manufacturing of equipments, the PM sends together with the order a copy of the relevant drawing. The management of CHERO PIPING S.p.A. drawing files is not foreseen at suppliers' companies. The purchase orders can be sent to the supplier by fax, mail or e-mail. Order filing The purchase orders are filed by the Purchase Manager for at least 10 years. 7.4.3 Verification of the Product Bought When it is specified in the contract, the customer or one of his representatives can verify at our factory the product bought destined to his production, in order to check its conformity. All the material bought is checked upon receipt according to what foreseen by the P743. This procedure determines, for any kind of material: ⇒ Characteristics to verify; ⇒ Reference Documents; ⇒ Sampling; ⇒ Person responsible; ⇒ Methods of identification of the state of tests, controls and/or testing carried out upon receipt.

Besides, the P743 determines the methods for the control of the documents supporting the supplying. CHERO PIPING S.p.A. does not foresee any check of the material at suppliers’ factories, unless in case of repeated non-compliance of the supply.

7.5 Production and Supply of Services

7.5.1 Inspection of equipments and services bought by external suppliers

CHERO PIPING S.p.A. plans and checks the management of products and services according to precise conditions, in compliance with the procedure P750. When possible, these conditions include:

Availability of information about product features Availability of operating instructions Use of suitable equipments Availability and use of equipments for monitoring and measuring activities 33/46


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Implementation of technologies for monitoring and measuring activities Implementation of the methods of release, delivery and assistance.

7.5.2 Validation of the processes relevant to products and services

All production processes can be verified through following controls. They are intended to be validated on the basis of the final testing applied to the product. 7.5.3 Identifiability and traceability

CHERO PIPING S.p.A. ensures product identifiability and traceability during all the phases of manufacturing by applying the procedure P753 “Identifiability and Traceability”. CHERO PIPING S.p.A. controls and records the identifiability and traceability of the products when required by a specific law or by customers.

7.5.4 Customers’ properties

CHERO PIPING S.p.A. takes a lot of care to customer’s property while it is under company control or when used. Customers’ properties must be identified according to what foreseen by the procedure “Identifiability and Traceability” (P753). Customers’ properties must be kept and preserved in order to avoid any possible damage or alteration according to what foreseen by the procedure “Product preservation” (P755). Customers’ intellectual properties are safeguarded by specific confidential agreements stipulated with the customers. In case of damage, destruction or loss of a customers’ property, it is necessary to send immediately a communication to inform them about it. If some objects belonging to a customer are lost, damaged or result to be useless, this fact must be communicated to the customer and the relevant documents must be kept. Should the contract foresee the processing of the material provided by the buyer, it is controlled during the production according to the same procedures applicable to the materials usually provided and processed internally. In case of non-compliance, the distribution of the relevant minutes is extended to the buyer. The responsibility of the Company in this case is intended to be limited to the quality of the service provided and not to the quality of the material used, for this reason the certificates of final testing 3.1 are not issued. The batches of the above mentioned materials are identified by a metal red label in order to identify them from the remaining batches of company own material as no special area for the management of the products provided by the Buyer is foreseen.

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7.5.5 Customers’ properties CHERO PIPING S.p.A. maintains product conformity during its manufacturing as long as the delivery to the destination foreseen. The procedure P755 determines the methods through which t is possible to identify, handle, pack, keep and preserve the finished product, as well as its components.

7.6 Control of monitoring and measuring equipments

CHERO PIPING S.p.A. determined monitoring and measuring operations to carry out through the special equipments in order to stress the conformity of the product to the prearranged requirements. The procedure P760 “Management of control equipments” describes the processes used for managing adequately the above mentioned control equipments. In order to ensure valid results, the measuring equipments are:

• Calibrated or verified at arranged intervals (or before they’re used) according to measuring standards relevant to international or national regulations

• Adjusted or readapted if necessary • Identified as reliable for enabling the conditions of calibration to determine • Protected from adjustments that may invalidate the result of the measuring • Protected from damages or deteriorations during their handling, maintenance and preservation

The Quality Control verifies and records the validity of the measuring results. All the results of the adjustments and verifications are recorded and kept.

After Customer’s approval, the Person Responsible for Order Management organizes a meeting with the supplier chosen for the manufacturing of the equipment. During this meeting they discuss the conditions of supply of the order, plan the manufacturing activities and equipment testing and deliver the documents necessary for the manufacturing. The production process is managed through the following documents:

Form “Job order sheet” used for starting the production of a job order. It describes the products and special quantities to manufacture, regulations, specifications and reference drawings;

Form “Job order programme”. This form is issued only if requested by the Customer. It must contain the phases of product manufacturing and the forecast of their duration.

It is up to the Supplier to update, if necessary, the form “Job order programme” and inform CHERO PIPING S.p.A. about possible delays or problems found during the process. It is up to the supplier to carry out all the controls/testing foreseen by the Quality Control Programme (issued only for the suppliers delegated to the manufacturing of finished equipments) and inform, when required by the Programme, the ROM for his attendance. Tests, controls and/or testing must be carried out by using calibrated equipments (consult par. 7.7 of this document). Tests, controls/testing must be formalized, by the supplier, through his own system documents or, when required by the contract, on a report of CHERO PIPING S.p.A.

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Product release occurs only once carried out, obtaining positive results, the controls/testing foreseen by the Quality Control Programme A special procedure determines the methods of management, and the relevant responsibilities, of the production processes. 7.6.1 Validation of Special Processes As regards all the processes the result of which can’t be verified by subsequent monitoring or measuring activities, CHERO PIPING S.p.A. verifies that these processes are carried out by qualified operators supported by some procedures/instructions that determine the method of development of the company. These processes are validated by CHERO PIPING S.p.A. by verifying what follows: ⇒ Procedures relevant to the Production Processes in hand. ⇒ Lists of the equipments used for the carrying out of these processes. ⇒ Qualifications of the staff responsible for the execution of these processes (when applicable). ⇒ The execution of the Process. ⇒ Certifications of conformity/testing provided by the suppliers. ⇒ Data sheets of the products used.

7.6.2 Identification and Traceability CHERO PIPING S.p.A. determined an identification system such as to know the state of the products and the state of development in relation to monitoring and measuring requirements. This system is used both for the products bought and for the ones stored in our warehouse and it is sent to the suppliers who manufacture, on our behalf, the equipments. The identification of the products of CHERO PIPING S.p.A. is always clear and well determined, as regards both the materials upon receipt and semi-finished or finished products. A special procedure determines the methods of identification of: ⇒ Material upon receipt; ⇒ Material under production; ⇒ Finished products. All the materials that are considered to be non-compliant are suitably identified. When possible, the operator must keep the non-compliance material in the special area “Non-compliant Material”. Thanks to the above mentioned marking, CHERO PIPING S.p.A. has the possibility to find, for every single order and/or all item, what follows: ⇒ tests, controls and testing carried out; ⇒ staff who carried out the tests, controls and testing required; ⇒ possible intervention of external bodies for the execution of particular tests, controls and testing; ⇒ possible non-compliances found. 36/46


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Besides what mentioned before, through the filing of the documents in the job order book, we can determine the suppliers of raw materials and components. 7.6.3 Customer’s properties All the material provided by the Customer is managed according to what prescribed by the relevant PO. This document determines, for every kind of material, the controls that need to be carried out upon receipt. The material, once released, is adequately identified and stored. Storage conditions are such as to preserve its integrity. Possible non-compliances or inadequacies are communicated to the Customer. The decisions are formalized and managed like quality data. 7.6.4 Product preservation The Company makes use of a special area that allows the preservation of the components and finished equipments. All the materials, even during their stay in this area, are suitably identified. The material handling is carried out manually or by means of forklift trucks. This activity is executed according to what prescribed by current safety regulations. The activities of shipment and packing are established directly by the Customer.

7.7 Control of monitoring and measuring devices To carry out the working activity of CHERO PIPING S.p.A., we have determined the monitoring and measuring operations to execute by means of suitable equipments in order to stress the conformity of the product to the prearranged requirements. The periodical inspection of these equipments is carried out by the Quality Control and formalized on the form 7.6.1 “Calibration Report”. A special list (form 7.6.1) shows the equipments that need to be periodically checked and the relevant frequency of control. The criteria of acceptation are shown on the relevant Calibration Reports. It is up to the QAM to verify, during the qualification of the suppliers assigned to equipment manufacturing, that there’s a programme for the management and the periodical check of the equipments. It is up to the ROM to verify, during the periodical inspections, that the equipments used by the suppliers are regularly checked/calibrated against primary samples (calibrated by SIT centres or similar). It is up to the supplier to record, in the document system of CHERO PIPING S.p.A., the n° of registration of the equipments used for carrying out tests, controls and testing and the relevant n° of calibration report.

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8.1 General CHERO PIPING S.p.A. designed and applies monitoring, measuring, analysis and improvement processes, in order to:

• Prove product conformity • Ensure the conformity of the Quality Management System • Continuously improve the efficiency of this same System These processes, identified in documented procedures, describe the methods applicable, including the statistical techniques and the limits of their use. 8.2 Monitoring and Satisfactions 8.2.1 Customer’s satisfaction CHERO PIPING S.p.A. makes use of a system that allows to control the information relevant to customer’s perception about the capacity of the Company to satisfy his needs. This system foresees the periodical analysis of: ⇒ Returns / claims (both of technical nature or service) ⇒ Return information; ⇒ Client retention; ⇒ Compliance with contract terms; ⇒ Perception of the commercial service through direct interviews. Possible assessments, comments or suggestions from the buyer are formalized and considered during the review activity of the management. The Company does not foresee, for this activity, the use of tools such as “Customer Satisfaction Questionnaires” as they are not considered to be reliable. 8.2.2 Internal audit In order to ensure the application of the company policy and verify the correct application of law requirements, of the directives cited in the Quality Manual and in the Operating Procedures, the QAM programmes and plans every year, by using the form 8.2.0 “Inspection Plan”, a series of internal and external inspections in order to control all company activities. The internal inspections can be carried out directly by the staff of CHERO PIPING S.p.A. or by external consultants, but however by a staff independent from the persons who are directly responsible for the activities subject to inspections, by using as a reference the Quality manual and the Operating Procedures. If necessary, the person responsible for the inspection will prepare a list of the results for carrying it out in the best way possible. The results of the inspections are recorded on the form 8.2.1 “Inspection Report”.

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The Quality Assurance Manager prepares, together with the company managements, the programme of the audits. This programme involves all the activities of the company and must consider the strategic importance of every sector that will be audited. The programme of the audits specifies when they must be carried out and the sectors involved. Every sector of the company must be audited at least once a year. The table “Functional responsibility matrix and distribution of operative documents” shows the list of the procedures of the quality system that must be applied to all company sectors. The audit programme may be subject to changes made by the managements on the basis of:

Audit results Number of corrective actions Other problems arose during the audits.

The Quality Assurance Manager starts to carry out the audits by basing himself on the programme in his possession and identifies, if necessary, one or more support audits within the qualified company staff. The Quality Assurance Manager informs the person responsible for the sector to audit about the date and the programme of the audit, determines the audit contents by basing himself on the reference procedures for the sector to audit and, when foreseen, he sends a copy of the audit plan to other auditors. The Quality Assurance Manager assigns other auditors (if present) to the verification of the execution of previous corrective actions by giving them the form of the corrective action. During the audit, the person responsible for the area to audit must be always present. The auditors carry out the audit according to what foreseen by the audit plan, by using the suitable checklists and, at the end, drawing up the “Internal inspection report”. These reports show possible non-compliances found out. The compliance with the quality system and the standard ISO 9001 is verified by remarks, interviews and analysis of the recording of quality data. The completion of the previous corrective actions must be recorded in the special recording form of these same actions. Audit results must be recorded on the checklists used. When necessary, the auditors will meet at the end in order to agree upon new corrective actions. To conclude, the Quality Assurance Manager concludes the audit with a final meeting, in which the possible other auditors and the person responsible for the audited sector will participate, during which: the possible non-compliances found out are discussed and a judgment on the state of conformity of the inspected sector is expressed. The Quality Assurance Manager prepares the final report containing:

The description of the non-compliances found out The list of the corrective actions needed A copy of the filled in forms relevant to the corrective action

The Quality Assurance Manager will then arrange for the filing of the audit documents in the special folder. The audit file must contain:

the internal audit plan; the check – list; the report of the audits carried out, showing the references to the possible minutes relevant to the

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The person responsible for the activity verified countersigns in acceptance the result of the inspection and agrees with the Quality Manager, against lacks found out during the visit, the necessary corrective and/or preventive actions. These actions are managed according to what prescribed under the paragraph “Corrective and Preventive Actions” of this chapter. The frequency of execution of the Inspections can be increased because of:

particular contract needs; important company reorganizations; particularly serious lacks found out during the inspection;

in order to ensure that the compliance with the Quality System is reached and maintained. In this case the person responsible for the inspection notifies to the function interested the date of the inspection that will be executed according to the above mentioned criteria. The results of the inspections are shown to the GM during the meeting for the review of the Quality System, foreseen in the first part of the Manual. 8.2.3 Process Monitoring and Measuring In order to control and check the processes of the quality management system, CHERO PIPING S.p.A. adopts the following criteria:

Internal Inspections carried out by qualified staff (consult the paragraph relevant to Internal Inspections); Application of Statistical techniques, such as:

1. Internal Non-Compliances; 2. Customer’s claims; 3. Suppliers’ Quality Index; 4. Back analysis of job orders

This activity, developed by the Quality Manager, together with the various persons responsible for the company function, is introduced to the Management during the meetings about System Review. In case of possible lacks/the prearranged goals are not reached, the Quality Manager will research for the causes and arrange for suitable corrective actions in order to ensure the conformity of the products/system. Product Monitoring and Measuring In order to meet the requirements prescribed by the contract, CHERO PIPING S.p.A. prepared a special procedure that determines what follows:

1. Controls to carry out; 2. Persons responsible; 3. Documents applicable; 4. Recording Methods (these ones identify, in addition to the control/testing carried out, the person/s who

authorize product release or plant validation); 5. Methods to adopt for identifying the state of the products/controls and/or testing; 6. Methods to adopt in the presence of non-compliances.

Product release only occurs after a positive result of all the controls/testing foreseen by the documents applicable. 41/46


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8.3 Control of non-compliant products

Treatment of Non-compliances

Once found out a non-compliance of raw materials, components, etc., the operator must identify the non-compliant material by a special red card, position it in the area for non-compliant materials (when possible) and fill in the form "Non-compliance Report" by writing all the information suitable for univocally identify the NC material, the supplier and the kind of NC found out. Once completed the drawing up, the NCR must be delivered to the QAM for the analysis (carried out together with the Technical Department Manager when necessary) of the non-compliances. The QAM will have the responsibility to decide whether to: • Accept (the material must be identified as compliant material); • Reject (the material must be identified as NC material and isolated); • Return the material to the supplier for having it reprocessed or repaired (the material must be identified

by a yellow card); • other. When the NC material is returned to the supplier for having it repaired, reprocessed or selected, the Supervisor has the responsibility to, when the material comes back, verify it, with the drawings and/or the specifications applicable, and record the result of the controls in the Non-Compliance Report under the paragraph Resolution of the Non-Compliance.

It is up to the QAM to take suitable measures in order to prevent the non-compliances from occurring again. On this purpose, the causes of the non-compliances must be found out. The identification of the potential cause/s may imply changes in the processes of manufacturing, control or other (consult the paragraph "Corrective and Preventive Actions").

Customers’ returns

All the claims or returns from the customer are recorded by the QAM in the form “Customer’s Claim”, by indicating what follows:

customer’s name; n° of the order relevant to the contested material, when communicated by the customer; n° of the job order; n° of the dispatch note, when communicated by the customer; reason of the claim; if the customer wants to give back the material.

The claim or the material returned is always analyzed by the QAM and the Sales Executive. The results and the possible actions to carry out for solving the problem are registered by the QAM in the special form “Customer’s Claim”. This one is distributed for information to the following functions:

General Management; Sales Executive.

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The result of the analysis of the claim or return are communicated to the customer by sending to him this form.

System non-compliances

They are managed according to what prescribed under the paragraph “Quality Internal Inspections” of this chapter.

Filing of Non-Compliance Reports

The Non-Compliance Reports are filed by the Quality Manager. This document is used for the analysis of company defectiveness.

8.4 Data analysis CHERO PIPING S.p.A. provides for collecting and elaborating the data in order to verify the adequacy and effiectiveness of the Quality Management System. The Statistical Techniques applied are:

Internal Non-Compliances; Customer’s Claims; Supplier’s Quality Index; Back analysis of job orders.

What mentioned here above aims at monitoring: Customer’s Satisfaction; Conformity to Product Requirements; Trend of Processes and Products; Assessment of Suppliers.

Supplier reliability A supplier is considered to be reliable when the product supplied, resulted to be non-compliant, does not exceed 1% of the total considered. Product conformity The product conformity of CHERO PIPING S.p.A. is obtained when the following conditions occur:

Any of the Non-Compliances found out is caused by design errors; The finished product, that shows a qualitative non-compliance (dimensional or relevant to defects) must not

exceed 1% of the total considered. Trend of the production department in terms of yield and reliability In order that the production department is considered to be reliable, it is necessary for the product rejected, both during the productive phase and subsequent controls (VNC), to not exceed 1% of the total worked. In order that the yield of the production department is considered to be positive, it is necessary for the hourly costs of the machines to be included in the following limits: 43/46


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Working centres : 60 € Transfer : 50 € Traditional lathes and cutters : 40 € Sawing machines : 30 € Customer satisfaction The Customer can consider himself satisfied when the delivery times and the quantity of the product supplied have been respected and are included in the following limits:

The days of delay as to the contract expiry date must not exceed 15 The percentage of the product rejected by the customer must not exceed 11% of the total considered. Alternatively, the cost of the claim must not exceed 1% of the total sales proceeds relevant to the batch

considered. Improvement margin The above mentioned limits of acceptability may be further reduced from year to year according to the plan of the aims. 8.5 Improvement 8.5.1 Continuous improvement The aim of CHERO PIPING S.p.A. is to improve continuously the quality management system and the internal organization. On this purpose, the Company considers the inspections, the corrective and preventive actions, the quality policy and the management reviews as instruments suitable for identifying the areas that need to be improved inside the organization. Corrective action: Action to carry out for eliminating the cause of a non-compliance found out, or other unwelcome situations. (A non-compliance may derive from different causes). Preventive action: Action to carry out for eliminating the cause of a potential non-compliance or unwelcome potential situations. (A potential non-compliance may derive from different causes). Note: A preventive action is adopted in order to avoid that a non-compliance occurs, while a corrective action is adopted in order to avoid its repetition. 8.5.2 Corrective actions The corrective actions are originated by a careful analysis conducted for identifying and eliminating the causes that generated a non-compliance in every company sector. The corrective actions can be generated after analysis of:

non-compliances found on the product; non-compliances caused by suppliers; non-compliances found out during internal inspections; announcements, claims or returns of materials from the customers; 44/46


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data of internal defects. All company functions may propose corrective actions. All the employees have the responsibility of asking for a Corrective Action when they identify a non-compliance. The Coordinator of Corrective Actions has the responsibility to identify the person responsible for the internal inspections and establish a date within the Corrective Action must be carried out. The Coordinator of the Corrective Actions has the responsibility of filing and making traceable the Requests for Corrective Actions on the basis of what foreseen by this procedure. The person responsible for the approbation is the Quality Assurance Manager or the GM. Should an employee find out a non-compliance relevant to products or processes, he must drawn up a request for Corrective/Preventive action RCPA and send it to the Coordinator of Corrective Actions. When a complaint is received from a customer, the employee who receives it must draw up a RCPA and send it to the coordinator of the Corrective Actions. All the remarks relevant to the internal inspections are documented on a RCPA. The corrective actions are recorded in the special form called “Corrective actions – Preventive actions”. In this form are registered:

the non-compliance that need to be eliminated; the possible causes that generated the non-compliance; the action proposed for eliminating the non-compliance; the function that has to apply the corrective action; the results of the actions carried out.

The coordinator of the Corrective Actions assigns a number to every RCPA and identifies the receiver of the execution of the Corrective Action and establishes a date within the Corrective Action must be carried out. The RCPA is recorded in the Database of the Corrective Actions by the coordinator of the Corrective Actions. Every RCPA is assigned to a person responsible who searches for and determines the cause of the problem and suggests a Corrective Action. Besides, this person identifies the person having the suitable responsibility and authority to carry out this Action. Once drawn up the form RCPA, it is given back to the Coordinator of the Corrective Actions who files it in the database and establishes the schedule for the following inspection. Every week the Coordinator of the Corrective Actions controls which are the RCPA to verify and assigns them to the appropriate persons responsible. The person who has been assigned to the implementation of the Corrective Action analyses the results of the action undertaken, records the results in the RCPA and signals if the action has been effective or not. Then, he returns the RCPA to the coordinator of the Corrective Action. The Coordinator of the Corrective Actions closes the Corrective Action. In case of the action has not been effective, it will be necessary to open a new RCPA.

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The Coordinator of the Corrective Actions prepares a summary of the Corrective Actions undertaken so that they can be analyzed during the management review meetings.

8.5.3 Preventive actions

These actions are decided as a consequence of analyses carried out for identifying and eliminating the potential causes of a non-compliance in every company sector. The preventive actions can be generated by:

analysis on statistical basis management review (improvement plans); internal inspections; claims; various sources.

All company functions can propose preventive actions. The person responsible for the approbation is the Quality Assurance Manager or the GM.

The preventive actions are recorded in the form “Corrective actions – Preventive actions”. In this form is recorded what follows:

potential cause of non-compliance to prevent; actions proposed for the prevention of the non-compliance; department/service responsible for the execution of the preventive action; date within the preventive action must be carried out; the results of the actions carried out.

The actions to undertake may include: changes in the production process; changes in the technical documents or operating procedures; further staff training; research for new suppliers; research for new control methods; adoption of new equipments; etc.

The results obtained by the carrying out of the preventive actions must be recorded in the form “Corrective and Preventive Actions”.

Verification of the actions undertaken

The QAM verifies, at the end of the period established, the effective solution of corrective and preventive actions. In case of the action foresees some changes in the documents, the QAM is responsible for the updating of all the documents applicable to the variations. It is up to the General Manager to control and approve it. Every year, during the phase of management review, the GM and the QAM have to review the corrective/preventive actions carried out.

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Capitolo 1 Chero - Chero Piping · CHERO PIPING S.p.A. works. In this manual all the activities...

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Transcript of Capitolo 1 Chero - Chero Piping · CHERO PIPING S.p.A. works. In this manual all the activities...