Manuale Qualità ISO 9000 ed. 2000
Transcription
Manuale Qualità ISO 9000 ed. 2000
IMSM INTEGRATED MANAGEMENT SYSTEM MANUAL according to standards UNI EN ISO 9001:2008 UNI EN ISO 14001:2004 BS OHSAS 18001:2007 SA8000:2008 EN ISO/IEC 80079-34:2012 The present Document is the of property of BIFFI ITALIA S.r.l. and cannot be reproduced or disclosed without written authorization by Management. INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 2 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL REV DATE DESCRIPTION PREPARED CHECKED APPROVED 0 09/01/2006 1st Issue ASGI RSGI DDL 1 13/07/2007 DDL modified and RLS added ASGI RSGI DDL 2 15/01/2008 Insertion ref. BS OHSAS 18001:2007 ASGI RSGI DDL 3 16/04/2009 Modification § 4.4.1 ASGI RSGI DDL ASGI RSGI DDL ASGI RSGI DDL Updated § 3; § 4.2; 4.3.1; 4.3.3; 4.4.3; annex eliminated Updated for integration with ISO 9001 Manual and SA8000 contents 4 14/03/2011 5 08/01/2013 6 11/03/2013 Modification § 9.7.4 ASGI RSGI DDL 7 19/05/2014 Modification § 6.2 ASGI RSGI DDL ASGI RSGI DDL ASGI RSGI DDL 8 11/11/2014 9 02/02/2015 Updated with ISO/IEC 80079-34:2012 EXPLOSIVE ATMOSPHERES – Part 34: Application of quality systems for equipment manufacture Updated § 4 with reference to Pentair Valves and Controls Quality Manual INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 3 of 80 CONTENTS 1 PURPOSE AND SCOPE OF APPLICATION OF THE SGI ........................................................................................... 8 2 STANDARD REFERENCES....................................................................................................................................11 3 DEFINITIONS......................................................................................................................................................11 3.1 TERMS, DEFINITIONS AND ABBREVIATIONS................................................................................................................. 11 3.2 CORRESPONDENCES WITH THE STANDARDS UNI EN ISO 9001, UNI EN ISO 14001, BS OHSAS 18001, SA8000 AND ISO/IEC 80079-34 (CHAPTER 7) ........................................................................................................................................ 17 4 SGI REQUIREMENTS ..........................................................................................................................................25 4.1 STRUCTURE OF THE INTEGRATED MANAGEMENT SYSTEM ............................................................................................. 25 4.2 DOCUMENTATION REQUIREMENTS........................................................................................................................... 28 4.2.1 List of documents of the Integrated Management System ......................................................................... 28 4.2.2 SGI Manual.................................................................................................................................................. 28 4.2.3 Monitoring documents................................................................................................................................ 29 4.2.4 Monitoring records ..................................................................................................................................... 29 5 MANAGEMENT RESPONSIBILITY .......................................................................................................................31 5.1 MANAGEMENT COMMITMENT: RESPONSIBILITY AND AUTHORITY ................................................................................... 31 5.2 FOCUS ON THIRD PARTIES INVOLVED ........................................................................................................................ 31 5.2.1 Customer-orientation .................................................................................................................................. 31 5.2.2 Environmental aspects ................................................................................................................................ 32 5.2.3 Identifying danger, risk assessment and defining monitoring systems ...................................................... 32 5.2.4 Legal and other provisions .......................................................................................................................... 34 5.3 SGI POLICY ......................................................................................................................................................... 35 5.4 PLANNING .......................................................................................................................................................... 36 5.4.1 Objectives and improvement plans ............................................................................................................. 36 5.4.2 Planning of the Integrated Management System ....................................................................................... 37 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION ................................................................................................... 38 5.5.1 Responsibility and authority ....................................................................................................................... 38 5.5.2 Management Representative, RSGI, ATEX Manager and RLSA8000 .......................................................... 38 5.5.3 Communication ........................................................................................................................................... 40 5.6 MANAGEMENT REVIEW......................................................................................................................................... 41 6 RESOURCE MANAGEMENT ................................................................................................................................44 6.1 6.2 6.3 7 AVAILABILITY OF RESOURCES................................................................................................................................... 44 HUMAN RESOURCES ............................................................................................................................................. 44 INFRASTRUCTURES AND WORK ENVIRONMENT (6.4) ................................................................................................... 47 PRODUCT DEVELOPMENT .................................................................................................................................49 7.1 PRODUCT PLANNING AND DEVELOPMENT ................................................................................................................. 49 7.2 PROCESSES RELATED TO THE PARTIES INVOLVED .......................................................................................................... 51 7.3 DESIGN AND DEVELOPMENT ................................................................................................................................... 52 7.3.1 Design and development planning ............................................................................................................. 52 7.3.2 Design and development input elements .................................................................................................... 53 7.3.3 External input elements .............................................................................................................................. 53 7.3.4 Internal input elements ............................................................................................................................... 53 IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 4 of 80 7.3.5 Design and development output elements ................................................................................................. 54 7.3.6 Design and development review ................................................................................................................. 54 7.3.7 Design and development verification.......................................................................................................... 54 7.3.8 Design and development validation............................................................................................................ 54 7.3.9 Monitoring design and development modifications ................................................................................... 54 7.4 PROCUREMENT .................................................................................................................................................... 55 7.5 SERVICE DEVELOPMENT AND PROVISION ................................................................................................................... 56 7.5.1 Monitoring production and provision of services ........................................................................................ 56 7.5.2 Operational monitoring .............................................................................................................................. 57 7.5.3 Preparing for emergencies and reaction ..................................................................................................... 58 7.5.4 Validation of processes for production and provision of services ............................................................... 58 7.5.5 Identification and traceability ..................................................................................................................... 59 7.5.6 Customer property ...................................................................................................................................... 59 7.5.7 Product storage........................................................................................................................................... 59 7.6 MONITORING CONTROL AND MEASUREMENT DEVICES ................................................................................................. 59 8 MEASUREMENTS, ANALYSIS AND IMPROVEMENT ............................................................................................61 8.1 GENERAL INFORMATION ........................................................................................................................................ 61 8.2 MONITORING AND MEASURING .............................................................................................................................. 63 8.2.1 Customer satisfaction ................................................................................................................................. 63 8.2.2 Internal Audit .............................................................................................................................................. 64 8.2.3 Monitoring and measuring processes ......................................................................................................... 64 8.2.4 Aspects related to quality ........................................................................................................................... 64 8.2.5 Assessment of compliance with provisions ................................................................................................. 65 8.2.6 Monitoring and measuring products .......................................................................................................... 65 8.3 MANAGING NON-CONFORMITY ............................................................................................................................... 66 8.4 DATA ANALYSIS .................................................................................................................................................... 66 8.5 IMPROVEMENT .................................................................................................................................................... 67 8.5.1 Continuous improvement ............................................................................................................................ 67 8.5.2 Corrective actions........................................................................................................................................ 67 8.5.3 Preventive actions ....................................................................................................................................... 68 9 ADDITIONAL ASPECTS OF SOCIAL RESPONSIBILITY ............................................................................................70 9.1 CHILD LABOUR ..................................................................................................................................................... 70 9.1.1 Purpose ....................................................................................................................................................... 70 9.1.2 Introduction ................................................................................................................................................ 70 9.1.3 Opposition to the use .................................................................................................................................. 71 9.1.4 Use of children or young workers ............................................................................................................... 71 9.2 FORCED LABOUR .................................................................................................................................................. 71 9.2.1 Purpose ....................................................................................................................................................... 71 9.2.2 Introduction ................................................................................................................................................ 71 9.2.3 Overtime ..................................................................................................................................................... 71 9.2.4 Holidays and leave ...................................................................................................................................... 72 9.2.5 Penalties...................................................................................................................................................... 72 9.2.6 Loans ........................................................................................................................................................... 72 9.2.7 Health and Safety........................................................................................................................................ 72 9.3 FREEDOM OF ASSOCIATION AND RIGHT TO COLLECTIVE BARGAINING ............................................................................ 73 9.3.1 Introduction ................................................................................................................................................ 73 9.3.2 Collective Bargaining .................................................................................................................................. 73 9.3.3 Freedom of association ............................................................................................................................... 73 9.4 DISCRIMINATION .................................................................................................................................................. 73 IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 5 of 80 9.4.1 Purpose ....................................................................................................................................................... 73 9.4.2 Definition of competences .......................................................................................................................... 74 9.4.3 Personnel recruitment ................................................................................................................................. 74 9.4.4 Definition of the initial salary ...................................................................................................................... 74 9.4.5 Definition of the trial period ........................................................................................................................ 74 9.4.6 Training ....................................................................................................................................................... 74 9.4.7 Organization of overtime ............................................................................................................................ 75 9.4.8 Organization of holidays ............................................................................................................................. 75 9.4.9 Dismissal ..................................................................................................................................................... 75 9.4.10 Retirement .............................................................................................................................................. 75 9.4.11 Freedom of exercise of the rights of the person ..................................................................................... 75 9.4.12 Personnel protection............................................................................................................................... 76 9.4.13 Interim labour ......................................................................................................................................... 76 9.4.14 Protected categories ............................................................................................................................... 76 9.5 DISCIPLINARY PROCEDURES .................................................................................................................................... 76 9.5.1 Purpose ....................................................................................................................................................... 76 9.5.2 General Information.................................................................................................................................... 77 9.5.3 Type of applicable penalties in agreement with the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS (ref Articles 7, 8, 9, 10 and 11 – Title VII – Section IV) ........................................................................... 77 9.5.4 Conduct subject to penalty ......................................................................................................................... 77 9.5.5 Rebuttal ...................................................................................................................................................... 78 9.5.6 Responsibility and records .......................................................................................................................... 78 9.6 WORKING HOURS ................................................................................................................................................. 78 9.6.1 Purpose ....................................................................................................................................................... 78 9.6.2 Analysis of the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS ..................................... 78 9.6.3 Legislation on part-time work ..................................................................................................................... 78 9.6.4 Working hours............................................................................................................................................. 79 9.6.5 Organization of overtime ............................................................................................................................ 79 9.7 REMUNERATION .................................................................................................................................................. 79 9.7.1 Purpose ....................................................................................................................................................... 79 9.7.2 Salary .......................................................................................................................................................... 79 9.7.3 Deductions and readability of the "payslip" ............................................................................................... 79 9.7.4 Salary payment procedures ........................................................................................................................ 80 IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 6 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL PRESENTATION OF BIFFI ITALIA S.R.L. BIFFI ITALIA S.R.L. has been a leading manufacturer of valve actuators for more than 50 years. BIFFI began their operations in 1955 in the town of Fiorenzuola d'Arda (Piacenza), located in Italy's northern industrial area. The factory moved to its present location in 1969, with a substantial expansion of the facility in 1978. 2 A further expansion in 1996 building of 2,715 m provided the factory with new automated 2 painting facilities. BIFFI ITALIA S.R.L. therefore now has a covered area of 16,785.91 m , which includes factory floor space, warehouses and offices. BIFFI ITALIA S.R.L. is the only actuator manufacturer which can offer Customers worldwide a comprehensive range of standard as well as specifically designed customized actuation products aimed at meeting all industrial regulations and the most special Clients' requirements. In fact, the range includes electric actuators, tires, hydraulics, gas-hydraulics and subsea actuators, all available with a full complement of accessories suitable for a wide range of applications. In 1989, BIFFI was acquired by the KEYSTONE INTERNATIONAL Inc. Group, leader in flow control. In 1997 the whole Keystone group was acquired by TYCO INTERNATIONAL LTD, a global manufacturer, installer and distributor of products for a broad spectrum of markets: flow and process control, fire and safety, telecommunications. BIFFI ITALIA S.R.L. participates in this market with its Italian facilities, the assembly operation in Houston (Texas) as well as distribution centres throughout Europe, Africa, the Middle and Far East, Australia and Japan. In 2012 the whole TYCO INTERNATIONAL LTD group was incorporated by PENTAIR Inc through a merger agreement. The company resulting from the merger will be in a position to provide our customers with a more comprehensive product range and complementary solutions. It will have extensive presence in final key markets, with greater opportunities to capitalize the growth trend in the energy, infrastructure and industrial sectors worldwide. Pentair is a diversified company operating in the industrial sector and based in Minneapolis, Minnesota. Its company Water & Fluid Solutions is a global leader in the supply of products and systems for the handling, treatment and storage of water. Its company Equipment Protection is leader in the design and production of products for IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 7 of 80 thermal management and enclosures for the protection of sensitive electric components and the people that use them. With a turnover of 3.5 billion dollars in 2011, Pentair employs over 15,000 people worldwide. BIFFI ITALIA S.R.L. has a modern facility with state-of-the-art equipment, in which the Industrial and Application Engineering departments use a completely automated computer system for the design, and the engineers of the Research and Development department constantly develop technical innovations that will allow maintaining a leading position in its sector thanks to the application and development of the latest technologies. The Technical and Sales Offices are always available to meet any Client requests. The facility in Fiorenzuola has a department in which, thanks to simulators that reproduce real operating conditions of the actuator on the valve, actuators are tested that develop a coupling up to 600,000 Nm. BIFFI ITALIA S.R.L. individually tests and certifies every actuator manufactured, and is pleased to welcome all its clients to the facility, engineering companies or valve manufacturers that would like to see the tests. BIFFI ITALIA S.R.L. has always pursued the aim of supplying a top-quality product completely in accordance with Customer specifications, always delivering within the time limits agreed. The intention of implementing a true culture of Quality Service, in addition to the incessant search for a product with ZERO DEFECTS allowed obtaining the certification according to the standard ISO 9000, since 1993, to cover all the services provided by the international institute Det Norske Veritas. Moreover, BIFFI ITALIA S.R.L. boasts the certifications UNI EN ISO 14001, BS OHSAS 18001 and SA 8000, received by the international institute Det Norske Veritas and the Product Quality Assurance Notification for equipment intended for use in potentially explosive atmospheres received by the international institute INERIS. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 8 of 80 1 PURPOSE AND SCOPE OF APPLICATION OF THE SGI BIFFI ITALIA S.R.L., with the aim of carrying out its activities in the best way possible and improving the environment in which it operates, decided to adopt an Integrated Management System for Quality, the Environment, Safety and Social Responsibility compliant with the standards UNI EN ISO 9001:2008, UNI EN ISO 14001:2004, BS OHSAS 18001:2007, SA8000:2008 and ISO/IEC 80079-34:2012. The SGI adopted by BIFFI ITALIA S.R.L. establishes the management requirements that allow expressing company policy and setting objectives to achieve continuous improvement of company services, as well as objectives that allow the organization to identify and manage business risks and improve performance. The SGI continuously establishes, documents, implements, maintains and improves the company management system, in compliance with the requirements of the International Standards UNI EN ISO 9001:2008, UNI EN ISO 14001:2004, BS OHSAS 18001:2007, SA8000:2008 and ISO/IEC 80079-34:2012. The following diagram presents the fundamental processes on which the standards UNI EN ISO 9001:2008, UNI EN ISO 14001:2004, BS OHSAS 18001:2007, SA8000:2008 and ISO/IEC 80079-34:2012 are based: IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 9 of 80 Continuous Improvement Management Review Policy Audit Planning Assessment and Functioning IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 10 of 80 The present Manual and the SGI described therewith, apply to the planning and production of electric actuators, tires, hydraulic, gas-hydraulic and subsea for the industry and relevant monitoring systems by means of the following phases: mechanical processing; degreasing and phosphating; intermediate and final painting; sale and after-sales assistance phase, complying with contractual requirements and applicable binding ones. Exclusions are not expected regarding the points in chapter 7 of the reference standard UNI EN ISO 9001:2008. The present Manual was developed with a view to providing parties involved (within and outside the Company) with a clear and concise image of the approach of BIFFI ITALIA S.R.L. to quality and environment management by illustrating the main aspects elements required to allow the reader to understand the procedure by which the company acknowledged and translated, in operating terms, the requirements of the standards ISO 9001, ISO 14001, BS OHSAS 18001, SA8000 and ISO/IEC 80079-34. The present document is one of the cornerstones, together with the Policy for Quality, the Environment, Safety and Social Responsibility, the commitment toward Customers, the community, partners and administrative and control authorities. The structure of this manual is articulated on the basis of voluntary standards applied, according to the correspondence table in paragraph 3.2. The parts related to ethics (standard SA8000), for aspects that do not correspond to other points of the standard UNIEN-ISO 9001 and 14001, BS-OHSAS 18001 and ISO/IEC 80079-34, are specifically outlined in chapter 9 of this manual. These activities are carried out at the site in Fiorenzuola d’Arda in the Province of Piacenza (Area Caselle San Pietro, 420). IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 11 of 80 2 STANDARD REFERENCES BIFFI ITALIA S.R.L. developed its integrated management system in accordance with: the model UNI EN ISO 9000:2005 - Quality management systems – Fundamentals and terminology; the model UNI EN ISO 9001:2008 - Quality management systems – Requirements; the model UNI EN ISO 9004:2009 - Managing an organization for long-term success The quality management approach; the model UNI EN ISO 14001:2004 –Environmental management systems – Requirements and manual for use; the model of the standard BS OHSAS 18001:2007 – Occupational health and safety management system – Assessment of occupational safety and health; the model SA8000:2008 – Social Accountability 2008; the standard CEI UNI EN ISO/IEC 80079-34:2012-03 - Explosive atmospheres - Part 34: Application of quality systems for equipment manufacture. The binding product requirements can be traced in appropriate documents managed at the Research and Development office of BIFFI ITALIA S.R.L. The main EU directives that constitute the references for the Biffi actuator are the following: machinery directives, low tension directives, electromagnetic compatibility, PED directives (pressure equipment) and ATEX/IECEx directives (potentially explosive atmospheres), with the subsequent amendments and integrations. 3 DEFINITIONS 3.1 Terms, definitions and abbreviations ISO 9001:2008 The terms and definitions used are those defined by the standard ISO 9000:2005. ISO 14001:2004 Environmental Aspects: element of an activity, product or service of an organization that can interact with the environment. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 12 of 80 Corrective Action: action to undertake to eliminate the cause of a problem (nonconformity) whose negative effects are already evident. Preventive Action: Action to undertake to eliminate the cause of a problem (nonconformity) that it is expected to occur. BS OHSAS 18001:2007 Serious Incident: unpleasant event that is cause of death, health risk, injury, damages or other risks. Audit: systematic review to determine whether the activities and related results correspond to the regulations and if these regulations are respected and suitable for the policy and objectives of the organization. Continuous improvement: Improvement of the health and safety management system, to improve global health and safety services in all activities, in line with the health and safety policy of the organization. Danger: source or situation with potential damage, in terms of injury or health risks, damages to things, damages to the work environment or a combination of these. Identification Of The Danger: procedure of identifying the existence of a danger, and defining its features. Incident: event that causes a serious incident or creates the conditions. Parties involved: individuals or groups that are involved in the health and safety management system of the organization. Non-Conformity: every deviation from work rules, practises, procedures, regulations of the management system etc. that could lead, directly or indirectly, to injuries or illnesses, damages to things, damages to the work environment, or to a combination of these. In the notion of NC it also includes "issues" according to the standard SA 8000. Objectives: the targets that an organization plans to reach in terms of health and safety. Occupational Health and Safety: conditions and factors that influence the well-being of employees, temporary workers, the personnel of the contractors, visitors and any other person that it is at the work place. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 13 of 80 Health and Safety Management System: the part of the global management system that facilitates the management of risks related to the activity of the organization. This includes the organizational structure, planning, responsibility, practises, procedures, processes and the resources to develop, implement, realize, review and maintain the health and safety policy of the organization. Organization: company, operator, firm, enterprise, authority or association or part thereof, whether juridical or not, public or deprived, that has own functions and administration. Service: measurable results of the health and safety management system, related to monitoring health and safety risks on behalf of the organization, on the basis of its policy and related health and safety objectives. Risk: combination of probability and results of a dangerous event. Risk Assessment: general assessment of the risk and decision regarding the fact that the risk is can be tolerated or not. Safety: absence of unacceptable risks Tolerable Risk: risk that was reduced to a level that can be bearable for the organization, in respect of its legal obligations and its health and safety policy. SA8000:2008 Recovery Action For Children: every type of support and necessary action to ensure the safety, health, education and development of children that were subject to child labour, as defined above, and finished such work. Child: any person under 15 years of age, unless local laws on minimum age provide a higher age for work or compulsory school, in which case the higher age is applied. Young Worker: any worker that exceeds the age of child as defined above and under 18 years of age. Child labour: any work carried out by a child under the age specified in the definition of child above, exception as provided by the ILO Recommendation 146. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 14 of 80 Forced labour: any work or service obtained by a person under any criminal threat and for which said person did not consent voluntarily. ISO/IEC 80079-34 Ex Component: part of Ex equipment or a module (other than an Ex cable gland), marked with the symbol “U”, which is not intended to be used alone and requires additional consideration when incorporated into Ex equipment or systems for use in explosive atmospheres. Ex Equipment: machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition. Ex certificate: document that assures the conformity of a product with specified requirements for explosive atmospheres. Manufacturer: organization, situated at a stated location or locations, that carries out or controls such stages in the manufacture, assessment, handling and storage of a product that enables it to accept responsibility for continued compliance of the product with the relevant requirements and undertakes all obligations in that connection. Contract: requirements forming an agreement between a manufacturer and a customer and transmitted by any appropriate means. Customer complaint: reported written or verbal allegation made by a customer which concerns the identity, quality, durability, safety, security, conformity or performance of any equipment or protective system or component as defined in the Ex certificate. Product: Ex equipment, protective systems, safety devices, Ex Components and their combinations, as well as software and service as defined in 3.4.2 of ISO 9000:2005. Protective systems: design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Safety devices: devices intended for use inside or outside explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 15 of 80 Schedule drawing: drawing or document listed in the Ex certificate and/or test report. Related drawing: drawing or document not listed in the Ex certificate but linked to the schedule drawing, and used for example, for detailed manufacture of component parts technical documentation: documentation that enables the conformity of the product with the requirements of the standard(s) to be assessed. Manufacturer’s documentation: documents required by a manufacturer but not subject to assessment by body responsible for verification when making an application for a test report or an Ex certificate . Type of Protection: specific measures applied to Ex equipment to avoid ignition of a surrounding explosive atmosphere. Body responsible for verification: body which conducts documentation review and periodical audit as appropriate. The document contains the following abbreviations: ILO, International Labour Organization; RLSA8000 Workers' Representative for the SA8000 For further information refer to the integrated management system procedure related to "Managing SGI Documents". The following are the abbreviations of the functional authorities as per the organization chart. Initials DIR CdD QA PLANT ADM HR SALES PMO ENG R&D PL PR ACQ COLL SPED Authorities Management Management Committee Quality Plant Manager Administration Human resources Sales Project Manager Office Engineering Research and Development Product Line Production Procurement Entrance test Shipping/Invoicing IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL Initials MAN DDL DG D. Stab RSGI RSPP RLS MC CE SPP IMSM rev. 9 of 02.02.2015 page 16 of 80 Authorities Maintenance Employer General Manager/Delegated Executive for Environment and Safety Plant Manager Person in charge of the SGI Occupational Health and Safety Officer Workers' Health and Safety Representative Doctor Emergency Coordinator Health and Safety Officer The following abbreviations will be used in the document: SGI (IMS) MSGI PGI IOA I-SPP DR DGI Integrated Management System Integrated Management System Manual (IMSM) Integrated Management procedure Environmental Operating Instructions Safety Operating Instructions Environmental, Health and Safety Records Document Integrated Management Documents IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 17 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL 3.2 Correspondences with the standards UNI EN ISO 9001, UNI EN ISO 14001, BS OHSAS 18001, SA8000 and ISO/IEC 80079-34 (chapter 7) ISO 9001:2008 ISO 14001:2004 BS OHSAS 18001:2007 SA8000:2008 ISO/IEC 80079-34 (chapter 7) SGI Manual - State of the quality manual list of audits - Presentation Of BIFFI ITALIA S.R.L. 1 Purpose and scope of application of the quality management system 1 Purpose and scope of application 1 Purpose I Purpose and scope of application 1 Scope 1 PURPOSE and SCOPE of APPLICATION OF THE IMS 2 Standard references of the quality management system 2 Standard references 2 Publications of reference II Standard elements and their interpretation 2 Normative references 2 STANDARD REFERENCES 3 Terms and definitions used 3 Terms and definitions 3 Terms and definitions III Definitions 3 Terms and definitions 3 DEFINITIONS 4 Quality management system 4 Environment management system requirements 4 SSL management system requirements IV Social responsibility requirements 4 Quality management system 4 SGI REQUIREMENTS 4.1 Structure of the quality management system 4.1 Environment management system requirements 4.1 SSL management system requirements IV - 9 Management systems 4.1 General requirements 4.1 Structure of the Integrated Management System 4.2 Documentation requirements 9.16 Records 4.2 Documentation requirements 4.2 Documentation requirements 4.2.1 List of documents of the Quality Management System 4.2.1 General 4.2.1 List of documents of the Integrated Management System 4.2.2 Quality Manual 4.2.2 Quality manual 4.2.2 SGI Manual 4.2.3 Monitoring documents 4.2.3 Control of documents 4.2.3 Monitoring documents 4.4.4 Documentation 4.4.5 Monitoring documents 4.4.4 Documentation 4.4.5 Monitoring documents 9.16 Records IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 18 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL ISO 9001:2008 ISO 14001:2004 BS OHSAS 18001:2007 4.2.4 Monitoring records 4.5.4 4.5.4 5 Management Responsibility 5.1 Management commitment: responsibility and authority 5.2 Customer-orientation 4.2 4.4.1 4.3.1 4.3.2 Monitoring records Environmental policy Resources, roles, responsibility and authority Environmental aspects Legal and other provisions 4.2 4.4.1 4.3.1 4.3.2 Monitoring records SSL Policy Resources, roles, responsibility, financial responsibility and authority Quality Policy 4.2 Environmental policy 4.2 SSL Policy 5.4 Planning 4.3 Planning 4.3 Planning 5.4.1 Quality Objectives 5.4.2 Planning of the quality management system Objectives, goals and plans 4.3.3 9.1 Policy Identifying danger, risk assessment and defining monitoring systems Legal and other provisions 5.3 4.3.3 SA8000:2008 Objectives and plan ISO/IEC 80079-34 (chapter 7) SGI Manual 4.2.4 Control of records 4.2.4 Monitoring records 5 Management responsibility 5 Management Responsibility 5.1 Management commitment 5.1 Management commitment: responsibility and authority 5.2 Focus on third parties involved 5.2.1 Customer-orientation 5.2.2 Environmental aspects 5.2.3 Identifying danger, risk assessment and defining monitoring systems 5.2.4 Legal and other provisions 5.2 9.1 9.5 Policy Planning and implementation Customer focus 5.3 Quality policy 5.3 SGI Policy 5.4 Planning 5.4 Planning 5.4.1 Quality objectives 5.4.1 Objectives and improvement plans 5.4.2 Planning of the quality management 5.4.2 Planning of the Integrated Management System IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 19 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL ISO 9001:2008 ISO 14001:2004 BS OHSAS 18001:2007 SA8000:2008 ISO/IEC 80079-34 (chapter 7) SGI Manual system 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 4.4.1 Resources, roles, responsibility and authority 4.4.1 Resources, roles, responsibility, financial responsibility and authority 9.2 9.3 Management Representative Workers' Representative for the SA8000 5.5 Responsibility, authority and communication 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.1 Responsibility and authority 5.5.2 Management Representative 5.5.2 Management Representative, RSGI, ATEX Manager and RLSA8000 5.5.3 Internal communication 5.5.3 Communication 5.6 Management review 5.6.1 General 5.6 Management Review 5.5.2 Management Representative 5.5.3 Internal communication 5.6 Review of the organization by management and development plans 5.6.1 General 5.6.2 Review input 5.6.2 Review input 5.6.3 Review output 5.6.3 Review output 6 Resource Management 6 Resource management 6 Resource Management 6.1 Availability of resources 6.1 Provision of resources 6.1 Availability of resources 6.2 Human resources 6.2 Human resources 6.2 Human resources 4.4.3 4.6 4.4.1 4.4.2 4.4.3 Communication Management Review Resources, roles, responsibility and authority Skills, Training and 4.4.3 4.6 4.4.1 4.4.2 4.4.3 Communication, participation and consultation Management Review Resources, roles, responsibility, financial responsibility and authority 9.4 9.5 Management Review Planning and implementation IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 20 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL ISO 9001:2008 ISO 14001:2004 BS OHSAS 18001:2007 6.2.1 General Awareness 6.2.2 Competence, training and awareness Communication 6.3 6.4 Infrastructures and work environment 7 Product development 4.4 Implementation and operation 4.4 Implementation and operation 7.1 Product Planning and Development 4.4.6 Operational monitoring 4.4.6 Operational monitoring 7.2 Customer processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 4.3.1 4.3.2 4.4.6 7.2.3 Customer communication Identifying danger, risk assessment and defining monitoring systems Legal and other provisions Operational monitoring 7.3 7.3.1 SA8000:2008 SGI Manual 6.2.1 General 6.2.2 Competence, training and awareness 6.3 6.4 Infrastructures and work environment 6.3 6.4 Infrastructures and work environment 7 Product realization 7 Product development 7.1 Planning of product realization 7.1 Product Planning and Development 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2 Processes relevant to the parties involved 7.2.2 Review of requirements related to the product 7.2.3 Customer communication Design and development 7.3 Planning and development Design and development planning 7.3.1 Design and development planning 7.3.2 Design and development input elements 7.3.3 External input elements 7.3.4 Internal input elements 7.3.5 Design and development 4.3.1 4.3.2 4.4.6 4.4.6 7.3.2 Design and development input elements 7.3.3 Design and Environmental aspects Legal and other provisions Operational monitoring Operational monitoring Skills, Training and Awareness Communication, participation and consultation ISO/IEC 80079-34 (chapter 7) 4.4.6 Operational monitoring 9.5 9.13 9.14 Planning and implementation External communication and involvement of parties involved IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 21 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL ISO 9001:2008 ISO 14001:2004 BS OHSAS 18001:2007 SA8000:2008 ISO/IEC 80079-34 (chapter 7) SGI Manual development output elements output elements 7.3.4 Design and development review 7.3.6 Design and development review 7.3.5 Design and development verification 7.3.7 Design and development verification 7.3.6 Design and development validation 7.3.8 Design and development validation 7.3.7 Monitoring design and development modifications 7.3.9 Monitoring design and development modifications 7.4 Procurement process 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4 Procurement 7.4.3 Verification of purchased product 7.5 Service development and provision 7.5 Service development and provision 7.5.1 Monitoring production and provision of services 7.5.2 Operational monitoring 7.5.3 Preparing for emergencies and reaction 7.5.4 Validation of processes for production and provision of services 7.5.1 7.5.2 9.7 9.8 9.9 9.10 Monitoring suppliers/Subcontra ctors and SubSuppliers 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product 7.5 Production and service provision Monitoring production and provision of services 7.5.1 Validating production and service provision 7.5.2 Control of production and service provision Validation of processes for production and IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 22 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL ISO 9001:2008 ISO 14001:2004 BS OHSAS 18001:2007 SA8000:2008 ISO/IEC 80079-34 (chapter 7) SGI Manual service provision 7.5.3 Identification and traceability 7.5.3 Identification and traceability 7.5.5 Identification and traceability 7.5.4 Customer property 7.5.4 Customer property 7.5.6 Customer property 7.5.5 Product storage 7.5.5 Preservation of product 7.5.7 Product storage 7.6 Monitoring control and measurement devices 7.6 Control of monitoring and measuring equipment 7.6 Monitoring control and measurement devices 8 Measurements, analysis and improvement 8 Measurement, analysis and improvement 8 Measurements, analysis and improvement 8.1 General Information 8.1 General 8.1 General Information 8.2 Monitoring and measuring 8.2 Monitoring and measuring 8.2 Monitoring and measuring 8.2.1 Customer satisfaction 8.2.1 Customer satisfaction 8.2.1 Customer satisfaction 8.2.2 Internal Audit 8.2.2 Internal audit 8.2.2 Internal Audit 8.2.3 Monitoring and measuring processes 8.2.3 Monitoring and measurement of processes 8.2.3 Monitoring and measuring processes 8.2.4 Aspects related to quality 8.2.5 Assessment of compliance with provisions 8.2.6 Monitoring and measuring products 8.3 Managing not-conformity 8.2.4 8.3 Monitoring and measuring products Monitoring non- 4.5.1 Supervision and measurement 4.5.1 Measuring and monitoring services 4.5 Verification 4.5 Verification 4.5.1 Measuring and monitoring services 4.5.1 4.5.5 4.5.1 4.5.2 4.5.3 Supervision and measurement Internal Audit Supervision and measurement Assessment of compliance with provisions Non-conformity, 4.5.5 4.5.1 4.5.2 4.5.3 Internal Audit Measuring and monitoring services Conformity assessment Analysis of 9.5 9.15 9.5 Planning and implementation Verification access Planning and implementation 8.2.4 9.11 Dealing with 8.3 Monitoring and measurement of product Control of IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 23 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL ISO 14001:2004 BS OHSAS 18001:2007 compliant products 4.4.7 4.4.7 8.4 Data analysis 4.5.1 8.5 Improvement 8.5.1 Continuous improvement 8.5.2 Corrective actions ISO 9001:2008 8.5.3 Preventive actions 4.3.3 4.5.3 corrective and preventive actions Preparing for emergencies and reaction Supervision and measurement Objectives, goals and plans Non-conformity, corrective and preventive actions 4.5.1 SA8000:2008 incidents. Nonconformity, corrective and preventive actions Preparing for emergencies and reaction problems and implementation of corrective actions Measuring and monitoring services 4.3.3 Objectives and plan 4.5.3 Analysis of incidents. Nonconformity, corrective and preventive actions ISO/IEC 80079-34 (chapter 7) 9.11 Dealing with problems and implementation of corrective actions SGI Manual nonconforming product 8.4 Analysis of data 8.4 Data analysis 8.5 Improvement 8.5 Improvement 8.5.1 Continuous improvement 8.5.1 Continuous improvement 8.5.2 Corrective actions 8.5.2 Corrective actions 8.5.3 Preventive actions 8.5.3 Preventive actions 9 Aspects of social responsibility 1 Child labour 9.1 Child labour 2 Forced labour 9.2 Forced labour 3 Health and safety 9.3 Health and safety 4 Freedom of association and Right to collective bargaining 9.4 Freedom of association and Right to collective bargaining 5 Discrimination 9.5 Discrimination IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 24 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL ISO 9001:2008 ISO 14001:2004 BS OHSAS 18001:2007 SA8000:2008 ISO/IEC 80079-34 (chapter 7) SGI Manual 6 Disciplinary procedures 9.6 Disciplinary procedures 7 Working hours 9.7 Working hours 8 Remuneration 9.8 Remuneration IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 25 of 80 4 SGI REQUIREMENTS 4.1 Structure of the Integrated Management System The SGI adopted by BIFFI ITALIA S.R.L. allows the Company to: establish an integrated policy suitable to the actual business reality; identify the legislative provisions and applicable regulations; define objectives and appropriate goals and the consequent strategy for the achievement of the same; plan, manage, monitor and verify the application of the integrated management system to ensure suitability of the same to the integrated policy for quality, the environment, health and safety protection and social responsibility; identify the environmental aspects related to activities, products and services, to determine the related significant environmental impacts; identify the dangers related to the activities carried out at the organization; eliminate or reduce risks to employees and in general to people exposed to risks associated with their activity; adapt to any company changes; ensure that the product conforms to the type described in the Ex certificate and the technical documentation. The Quality Management System (QMS) is described in this Quality Assurance Manual are compliant with the Pentair Valves and Controls Quality Manual. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 26 of 80 The document structure of the Integrated Management System (SGI) is outlined in the following figure: Laws SGI Manual Procedures Technical specifications Operating Instructions Standards and Technical Regulations Manual Records The SGI implemented allows identifying the processes that impact company operations, to establish the proper flow and interaction, by managing them with appropriate controls and indicators. The following are the tables related to the company processes for product development in accordance with as provided in ISO 9001: primary implementation (tab.1); transversal support for general and improvement (tab.2); transversal support for implementation (tab.3). Tab. 1 Sequence of primary implementation processes Managing orders Design management Assistance and Customer complaints Tab. 2 Sequence of transversal support processes for implementation Resource Management Managing non-conformity Monitoring documents Monitoring quality records Supplier assessment IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 27 of 80 Tab. 3 Sequence of transversal support processes for improvement Review of the system and Annual Improvement Plan Managing continuous improvement projects Inspection verifications Managing corrective and preventive actions Costs indicators for quality and analysis of data trends Monitoring customer satisfaction and Complaints The interaction between support processes for implementation and general monitoring and improvement is complete and in general regards all company processes and is as illustrated in the following flowchart. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 28 of 80 4.2 Documentation requirements 4.2.1 List of documents of the Integrated Management System The Integrated Management System of BIFFI ITALIA is based on the following documentation: statements on the company policy, objectives and goals set; this Integrated Management manual; the procedures documented required by the international standard and the manual; the operating instructions and record documents; the documents required by the organization to ensure effective planning, operation and monitoring of its processes. 4.2.2 SGI Manual The MSGI is the document of reference for SGI and recalls the procedures developed to meet, at operating level, the requirements of the technical standards of reference. The Manual was divided in Paragraphs directly corresponding to the structure of the Standard UNI EN ISO 9001:2008 and within the same one (paragraph 3.2) the correspondences between the points of the standards of reference and the paragraphs of the materials are defined. The SGI Manual represents the first level of the System documentation and describes: the scope of application of the management system; reference to the management system procedures; the general procedure of application of the requirements of the standard of reference and related responsibility. The SGI Manual is a document subject to checking and editing rules, verification and approval are indicated in the PGI-08 "Managing SGI documents". The updating state of the various chapters of the Manual is indicated in the second cover page and updating of a single chapter of the MSGI requires updating of the general state of revision indicated on the cover. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 4.2.3 IMSM rev. 9 of 02.02.2015 page 29 of 80 Monitoring documents The activity is carried out according to as provided by the PGI-08 procedure "Managing SGI documents" to ensure that the updated editions of the documentation are available where necessary and accessible to who may request it, subject to any limits set by Management. The Manual is edited, reviewed and distributed according to as indicated in the abovementioned procedure which outlines the responsibility for preparing, modifying, verifying and approving the documents. The Manual, Procedures and Work Instructions are available to personnel in appropriate folders of the company computer system, and can be viewed and read by all users. 4.2.4 Monitoring records The activity is carried out according to as provided by the PGI-08 procedure "Managing SGI documents". The management documents, technical documents and record documents are all those documents cited in this Manual, in the Procedures, in the Operating Instructions and any other documents required to demonstrate conformity of the products/services provided by the company with current or voluntary requirements established by the Organization. All personnel at the company is responsible for to complying with the provisions of this Manual and properly managing (including filling in) the record documents therein recalled. The environmental records produced by BIFFI ITALIA show the objective evidence of: training activity performed; results obtained during the management of internal inspection verifications; company reviews that ensure the suitability and effectiveness of the SGI; record of the NC, AC and AP, incidents, missed incidents and injuries; reports on environmental incidents; reports on non-conformity related to internal social responsibility or notified by parties involved outside the Organization; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 30 of 80 information on the preparation of emergencies and replies; information on process-related quality aspects, significant environmental aspects, company risks identified and aspects related to social responsibility. Such documents, written or saved on IT support, allow extracting trend data and improving implementation and effectiveness of the SGI. BIFFI ITALIA monitors the management process of the records during all its phases: identification of the records, definition of related content, storage and protection, traceability, filing and destruction. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 31 of 80 5 MANAGEMENT RESPONSIBILITY 5.1 Management commitment: responsibility and authority In order to ensure the efficient operation of the SGI, the roles, responsibilities, tasks and reciprocal relations are identified for all personnel that manages, develops and monitors activities that have an impact on the quality of products and services, the environment and the health and safety of workers and social responsibility. In order to effectively carry out the company policy expressed and in order to successfully achieve the relevant objectives and continuous improvement of effectiveness of the SGI, Management has constituted an Executive Committee that provides the Corporate Functions with all the resources required to manage, execute and verify work, activating appropriate communication processes within the organization. The specific structure for system management is represented in the Company Organization Chart. In addition, Management is responsible for notifying the Organization of the importance of complying with Customer and binding requirements by developing personnel awareness of roles. The Corporate Functions have the necessary organizational freedom and authority to carry out the tasks and responsibilities outlined below and specified in detail in the flowcharts of applicable processes. The procedure of reference is the PGI-05 "Organizational Structure". 5.2 Focus on third parties involved 5.2.1 Customer-orientation Regarding the commitment stated in point 5.1, Management reminds all functions of the Organization clearly understand and fulfil Customer requirements. To this end, focus is on sales and assessment of implicit and explicit Customer requirements, to improve fulfilment. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 5.2.2 IMSM rev. 9 of 02.02.2015 page 32 of 80 Environmental aspects The DG with the assistance of the RSGI, have identified the significant environmental aspects and impacts, by carrying out an Environmental Analysis. The conclusions of such Analysis, are documented in specific documents recording the significance of environmental aspects, that constitute a point of reference for the organization of the SGI and for the definition of the Company Objectives concerning the environment. BIFFI ITALIA, to monitor the interactions of its activities with the environment, has an active procedure aimed at identifying, reviewing and assessing the environmental aspects and effects of its activities. The procedure of reference PGI-02 "Identifying and quantifying environmental aspects, dangers and occupational risk assessment" With a view to continuous improvement, BIFFI ITALIA through the SGI reviews and assesses the environmental aspects and impacts regarding modification to processes, current products and/or the introduction of new processes, products or services with the purpose of updating, if necessary the record documents of the significance of environmental aspects and considers them in determining the Company Objectives and Plans. The environmental aspects concerning the product are managed in accordance with the procedure P-SGQ-04 Design Management. The environmental aspects related to Supplier activities, which BIFFI ITALIA can influence, are assessed through specific questionnaires and on the basis of the analysis of the same, through audits. The environmental aspects related to Contractor activities, which BIFFI ITALIA can influence, are monitored through specific forms that are submitted and analyzed before the work that such companies shall carry out in accordance with the procedure PGI 14-02 "Discipline of contracted work". 5.2.3 Identifying danger, risk assessment and defining monitoring systems The DDL and the DG, with the assistance of the RSPP, the collaboration of the MC and the preventive consultation of the RLS, have established and edited documents to identify danger, assess risks and implement the necessary prevention, protection and control measures. The analysis considered: ordinary and extraordinary activities; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 33 of 80 activities of personnel that have access to the work place (including suppliers and visitors); means and plants at the work place provided by BIFFI ITALIA or third parties; product design (P-SGQ-04 "Design Management"). The results of these assessment and the effects of monitoring are taken into consideration upon defining health and safety objectives. The methodology used to identify danger and assess risks ensures that: the assessment is defined with respect to the purpose, the nature and times, to ensure that it is preventive rather than reactive; the assessment provides the classification of the risks and identification of those that should be eliminated or monitored, in the measures defined from the objectives and from the of company management program; the assessment is consistent with work experience and the ability to control current risks; the assessment provides feedback regarding the determination of the requirements of the means and plants, identification of the training requirements and/or development of operational monitoring; the assessment provides the monitoring of the necessary actions, to ensure effective and timely implementation. All the activities carried out at its premises and those that BIFFI ITALIA develops directly outside the premises (for example transportation, assistance at customer premises), as well as activities carried out by third parties at the company premises and that can interfere with its activities (contractors) are analyzed to identify the danger present as well as the organizational and operational aspects that can significantly influence Occupational Health and Safety (real or potential). The analysis is coordinated by the RSPP, in collaboration with the SPP and the entire company structure (executives, managers, workers), with the doctor and with external companies operating at the premises or locations where BIFFI ITALIA personnel operates. As specified previously, the risk assessment is preceded by the consultation, by the employer or delegate, of Workers' Health and Safety Representatives (RLS). Work IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 34 of 80 processes are divided in elementary phases, the sources and dangerous situations are identified and the risks are assessed. Occasional activities carried out at and outside the premises that Biffi Italia S.r.l. can influence are also considered, as much as possible. Solely and exclusively concerning Title IV (temporary or mobile sites) of Legislative Decree 81/08 the DDL appointed, by means of a contract, an external specialized firm to cover the following roles: works manager; safety and health coordinator during work activities; safety and health coordinator during work planning; Periodic reports issued by the Works manager allow Biffi Italia S.r.l. to monitor such activities. The risk assessment is updated annually during review and following possible events or situations that require it (in this case within 30 days from the introduction of the modification as provided by Legislative Decree 81/2008). In particular, the assessment is updated following: legislative, regulatory or voluntary agreement amendments; modifications in the elements of the activities carried out and/or products/services; audit results and, if necessary, policy modifications; projects concerning new products, machinery or new/modified plants or production lay-out modifications or modifications to substances/products used. Such projects involve the preventive consultation of the RSGI, RSPP and RLS. 5.2.4 Legal and other provisions BIFFI ITALIA maintains a procedure PGI-03 "Managing Legal Provisions" aimed at identifying and recording all the legal provisions, standards and regulations (codes of good practise, guidelines, etc.) concerning the environment and the protection of health and safety at work related to its activities, products and services. Such procedure will allow: IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 35 of 80 monitoring the amendments of regulatory and other provisions, concerning the environment, occupational health and safety and personnel management; BIFFI ITALIA personnel to access the regulations above; verifying regulatory compliance and suitability to BIFFI ITALIA regulations. 5.3 SGI Policy The SGI policy constitutes the basis on which BIFFI ITALIA has defined its objectives and goals. The organization, in collaboration with the parties involved, defined the policy ensuring that: it is easily comprehensible for the parties involved, both within and outside the Company; it has been edited considering product quality aspects (fulfilment of Customer expectations is among the main strategic company objectives), significant environmental aspects and resource availability as well as social responsibility aspects in which the Organization is involved; it is suitable to the nature and type of risks for the health and safety of the Organization; it is adopted and periodically reviewed in light of the internal audits and its consistency with company reality is assessed periodically; it is available to the public and therefore to the parties involved; it is communicated to all the people that work for the Company or on behalf thereof; it provides a framework of reference to review company objectives and goals; it includes a commitment to compliance with applicable legislation and any voluntary agreements signed by the company; it includes continuous commitment of the system adopted. The Policy Management of the SGI is indicated in the procedure PGI-01 Managing company policy. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 36 of 80 5.4 Planning 5.4.1 Objectives and improvement plans The Objectives and their review are defined by the DDL with the assistance of the DG and RSGI. BIFFI ITALIA ensures that the objectives related to quality, environmental aspects, occupational health and safety, as well as ethical and social responsibility are established for the relevant functions and company levels. The objectives are mainly inspired by the following: 1. complete fulfilment of Customer expectations, by complying with the binding regulations and specifications defined and/or provided; 2. improvement of the Organization, production standards and/or methodologies, in order to raise production efficiency levels and reduce internal costs, exploiting company management resources; 3. improvement of the Organization in order to raise environmental and occupational health and safety efficiency levels, exploiting company management resources; 4. improvement of the Organization in order to raise efficiency levels in terms of compliance with social responsibility principles, exploiting company management resources; 5. improving the sensitivity of the collaborative spirit and the focus of all staff on aspects defined as significant for the Organization; 6. full compliance with the relevant applicable legislation in force (ex. contract law, national labour contracts, binding environmental regulations, binding occupational health and safety regulations, IECEx, ATEX, PED, etc... ). The objectives and targets relating to each aspect considered significant by BIFFI ITALIA are specific and, where possible, measurable, consistent with the policy, including the commitment to continuous improvement and maintaining regulatory compliance. The definition of objectives and their review, is, as a rule, following a review of the contents of the policy, the analysis of regulations enacted at the national level and, where applicable , at the international level (ex. with regard to environmental regulations and health and safety at work appropriate registration documents of the regulatory changes updated on a quarterly basis are provided in terms of integrated management system), IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 37 of 80 analysis of the results of the Environmental Analysis (significance of environmental aspects), analysis of the contents of the risk assessment document, as well as the results of internal and external audits conducted by third parties. The objectives identified take into account the economic and financial resources of BIFFI ITALIA available and the best technology available. The periodic objectives are set during the Management Review and appropriately brought to the attention of all parties concerned with a specific document issued by the management. The Management Plan is the document through which BIFFI ITALIA makes actions operative concerning maintenance of regulatory compliance and continuous improvement of business performance in terms of quality, environment, occupational health and safety and social responsibility. In the Management program, performance indicators and the individual actions taken to achieve the objectives are identified. For each action, the manager for its implementation and the completion time and related resources are identified. If deemed necessary, in the Management Programme, the milestones that allow the progressive control of the actions with respect to objectives to be achieved shall be defined. The realization of these targets is monitored at set intervals and in case of inadequacy of their level of achievement, Corrective Actions will be taken. If a project relates to new developments or new or changed activities, products or services, the programs need to be revised, where necessary, to ensure that a correct SGI is applied to them. The procedure of reference is the PGI-05 "Management Program". 5.4.2 Planning of the Integrated Management System With regard to the aspects related to the Quality of products and services provided to Customers, BIFFI ITALIA planned activities by defining (when not specifically defined by the Customer) the quality of products/services provided, the performance characteristics and criteria for application of the quality management system, so that the quality level is achieved, maintained constant, made evident by the quality records. Such planning is therefore consistent with the general requirements of the system and objectives. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 38 of 80 However, in terms of the management of environmental, occupational health and safety at work, as well as social responsibility aspects, BIFFI ITALY planned activities highlighting which mandatory regulations are applicable to the company and how to monitor them for continuous improvement. Records relating to these aspects demonstrate the commitment of BIFFI ITALY and the Management Review illustrates the planning of activities at least annually. Even in this case, planning is therefore consistent with the general requirements of the system and objectives. All the elements, requirements and provisions adopted by the manufacturer in order to ensure compliance of the product with its Ex certificate and technical documentation shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of quality programs, plans, manuals and records. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority The definition of internal responsibilities of the Organization and their authority is illustrated in the Functional Organization Chart identified as "Organizational Chart" and available to all functions. Therefore, for more information please refer to the above document (Organizational Chart) and to define the specific responsibilities associated with the Integrated Management System, please refer to the content of specific procedures of the system. The organization chart also highlights the functions of ATEX Manager and PED Manager. 5.5.2 Management Representative, RSGI, ATEX Manager and RLSA8000 The Management of BIFFI ITALIA identifies and appoints the Management Representative for the Integrated Management System: the person shall have the authority and resources necessary to ensure the implementation and updating of the SGI and reports directly to the Management. The Management also empowers company managers to ensure that the SGI is operationally applied. The Management Representative is responsible for: ensuring the correct definition and implementation of business processes; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 39 of 80 reporting to management on the performance of the SGI and possible options for improvement; ensuring compliance with the system of all applicable national and/or international regulations; ensuring compliance of the management system with the standards adopted by the Organization; ensuring understanding of Customer requirements within the Organization. The RSGI (Integrated Management System Manager - Quality, Environment, Safety and Social Responsibility) continuously monitors the SGI so that it is effectively implemented. The RSGI is mandated by the RDD in determining whether the company is operating as planned so that, if a problem should arise, this can be addressed quickly and efficiently. This task is carried out by: ensuring the proper management and storage of quality, environment, safety and ethics records for the set of processes carried out by the Company; supporting Process Managers in the preparation, implementation and updating of processes according to the quality, environmental protection, health and safety of workers and social responsibility specifications defined by the company, helping Relevant departments in order to facilitate the process approach; supporting the Process Managers in the preparation and updating of the SGI documentation; ensuring that the procedures developed and approved are accessible to personnel concerned; monitoring and analyzing the performance of the SGI; offering training programs to raise awareness of the organizational structure in terms of quality, environment, safety and social responsibility; managing SGI audits and reporting to the Management Representative on the performance of the system and any need for improvement; ensuring follow-up of audits (checking that all non-conformities have been resolved). With regard to the ATEX/IECEx Directive, the figure of ATEX Manager is responsible for: IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 40 of 80 effectively coordinating activities for equipment intended for use in potentially explosive atmospheres; communicating with the body that issues the Ex certificate in relation to any proposed change to the project contained in the Ex certificate and the technical documentation; maintaining the link with the body responsible for monitoring the quality system; authorizing the initial approval process and changes to the designs when necessary; authorizing the concessions; reviewing the Ex certificate and the technical documentation and identifying any changes that may affect the conformity of the product with the certificate. In the field of Corporate Social Responsibility, in order to ensure that all workers have the Right to Representation and to facilitate communication with the Management on issues relating to social responsibility, the company trade union representation commissioned a Workers' Representative for the SA8000 . 5.5.3 Communication The company BIFFI ITALIA maintains a continuous channel for the dissemination of both internal and external information relevant to the SGI in this Company. This channel provides information on the Integrated Management implemented in the Company (Policy circulation, System procedures, Operating Instructions, etc...) and allows the organizational structure to communicate any suggestions for better Management of the system, any problems have not yet highlighted by the system, and more. For this reason, BIFFI ITALIA prepares the management procedures specified in PGI-07 "Communication Management" for the collection of notifications, their assessment and storage. Internal communication aims to involve those interested in the SGI and can be managed: by means of verbal communication; by notice in writing and delivered personally; by e-mail; by written notice posted on the company notice board; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 41 of 80 communications submitted anonymously in boxes for this purpose; through regular meetings that allow the comparison and discussion on company issues; by means of company TOTEMS (information towers); by means of BIFFI Magazine. In addition, BIFFI ITALIA establishes and keeps active the procedure PGI- 07 "Communication Management" with the purpose of ensuring that the organization responds appropriately to requests from external parties concerned (Customers, suppliers, Control Agencies and Public Authorities, environmentalist associations, residents, etc...), in relation to its aspects of quality, environmental protection, protection of the health and safety of workers and the responsible management of social and ethical aspects. For example, with regard to the aspects related to the quality of products/services offered to Customers, communication is often provided by the PMO function to share information regarding an order confirmation among the functions involved. However, it is emphasized that all company functions can convene and hold meetings to analyze and evaluate situations in particular as regards to interaction between a function and the other; the outcome of these meetings may prompt changes to the descriptions of company processes to improve the transmission of information and adapt to the changes. In order to pursue an open and effective dialogue with external parties, BIFFI ITALIA is committed to communicating to the public, when required, the information necessary to understand the environmental impact of its activities and the efforts it has made to ensure the highest levels of security and respect for social and ethical principles; such communication is implemented with the instruments from time to time deemed suitable for the purpose, first and foremost by making available to the public its Corporate Policy. BIFFI ITALIA keeps records of decisions made about methods of external communication and actual communication. 5.6 Management Review The SGI is reviewed periodically to ensure its suitability, adequacy and effectiveness over time. An assessment of the need for changes in the organization system, including policy and objectives is also under review. As a rule, the SGI review is at least annual. During the Review the following elements are assessed: IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 42 of 80 the results of internal audits and assessment of compliance with legal requirements and any requirements subscribed by BIFFI ITALIA performance monitoring and the degree of achievement of objectives and targets; verification of the conformity of the goods supplied and services provided; non-compliance including incidents, injuries; the status of preventive and corrective actions; subsequent actions to previous reviews by the Management; recommendations for improvement; circumstances arising from changes, including changes to legal requirements and any requirements subscribed by BIFFI ITALIA; the status of activities relating to the management of resources; communications from parties concerned, including complaints and Customer satisfaction. The review shall include the overall effectiveness of the quality management system with respect to equipment intended for use in explosive atmospheres. The purpose of the Review is formalized in an appropriate Report (see the procedure PGI13 "Management Review") whose contents summarize the convening of the meeting, the participants, the input documents considered, the topics covered and the actions decided; this report formalizes: need for new internal audits; need to take appropriate corrective/preventive actions; need for new resources and training plans; verification of the achievement of the objectives for improvement; improvement objectives of the SGI. The review report and improvement targets are presented in a meeting between the Management and the functions involved in order to present the contents. During this meeting changes can be made to the objectives if approved by the Management. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 43 of 80 The Review Report constitutes a record of the system. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 44 of 80 6 RESOURCE MANAGEMENT 6.1 Availability of resources BIFFI ITALIA has identified and allocated the resources necessary for the implementation and the achievement of the Corporate Policy on quality, environment, health and safety at work and in terms of social responsibility, the targets set in all areas and customer satisfaction. The term, resources is defined as the set of factors which, in various ways, help to the achievement of corporate goals, such as: internal personnel and their skills; suppliers; the flow of information, within the Company and to external entities; infrastructure and technologies used; economic resources of the Organization; work environment; natural environment. 6.2 Human resources The activity related to the definition of the human resource management policy, the organization model, the tools and the responsibility is supported by the HR procedure PENTAIR PFCI 01. The purpose of this procedure is: - motivate staff to achieve corporate objectives while maintaining high ethical and quality standards in the field of health, safety and environment, continuous improvement and a suitable environment to promote innovation; - manage and provide HR, recruitment and selection, assessment, training, compensation policies, in accordance with the requirements of the Quality Management System. BIFFI ITALIA has thus acquired, adopted and keeps the HR PENTAIR PFCI 01 ensuring skills to identify strength areas and areas for improvement. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 45 of 80 At the operational level, qualified staff is trained according to PGI-06 "Staff training" in order to ensure that the needed and identified skills for activities crucial for proper management of the system. BIFFI ITALIA establishes and maintains active procedures whose purpose is to ensure that the needs are identified in terms of expertise of staff whose professional activities may be crucial for proper management of the system. Personnel qualified as such must be able to acquire the necessary skills through education and appropriate training. Training is dispensed to anyone performs activities related to the management of environmental aspects, health and safety at work, the aspects of social responsibility and activities that affect compliance with the requirements of products. Each entity manager defines the skills and abilities necessary to perform the tasks within the service, both in relation to the demands of Customers who according to the continuous improvement of the SGI in the part relating to the management of the quality of the products and services provided and in the specific part concerning Corporate Social Responsibility. The skills required should emphasize: level of expertise required to perform a job; level of competence required for the performance of an activity for a service/organization; level of expertise held by the personnel of the organization. The need for training and education for issues related to quality and social responsibility aspects are, therefore, identified and planned by each Entity in collaboration with Human Resources and approved by the Management, considering the following factors: awareness and competence while performing the task ; introduction of new machinery, equipment; introduction of new processes, new activities, company expansion; expansion of resources and hiring new staff or need to change a role; non-compliance and customer complaints (formal and informal) or outcomes of audits; assessment and analysis of skills or requests from personnel or their managers in relation to experience gained; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 46 of 80 opportunities arising from courses / seminars / updates from external institutions; need for retention and/or new personnel qualifications such as non-destructive testing, welding, etc. Functional Managers ensure that personnel skills meet the requirements mentioned above and otherwise are suitable for operational effectiveness and efficiency of the Organization. The training is designed before delivery in order to highlight the objectives and expected results, the resources involved and the most appropriate training for the achievement of expected results. Periodically, after the provision of training activities, these documents are updated, reflecting the increased capacity acquired by the personnel involved. With regard to environmental aspects and health and safety at work, the training process and awareness of people, whose tasks can cause significant environmental impacts and be involved in the protection system of health and safety at work, play a role to ensure: awareness with respect to company policy, procedures and operational instructions, in order to improve their performance; knowledge of significant environmental aspects, under normal, abnormal and emergency conditions; the consequences, actual or potential, in the field of health and safety of their work activities and the benefits in terms of health and safety, improved personal performance; awareness of their roles and responsibilities in the implementation of the SGI; raising awareness of the consequences of behavioural deviations from the operating procedures established by the SGI. BIFFI ITALIA ensures that all persons having an impact on Ex compliance receive appropriate training. BIFFI ITALIA established the organizational structure in line with the business objectives of the Company and ensures the recruitment, selection and management of the personnel necessary for the efficient operation of business in terms of the environment and workplace safety. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 47 of 80 The training activities of BIFFI ITALIA consist in identifying training needs, in their execution, documentation, recording and subsequent evaluation of effectiveness. The DG is responsible for staff training, who then uses the RSGI for the organization of participation of personnel in the training and specialization courses, and of individual contributors in the identification of training needs. The training process is documented by the personal folders bearing the qualifications attained and required courses, proposals for training/education, annual training schedule, meeting minutes. The responsibilities of records management and the relative retention times are shown in the attached procedure PGI-08 "Document Handling of the SGI". 6.3 Infrastructures and work environment (6.4) The Management defines the suitability of the infrastructure and working environment based on the service to be provided and based on the Environmental Analysis and Risk Assessment Document. Infrastructure involves: buildings, workspaces and related services; equipment and process equipment (machinery, plant, equipment, hardware, software, etc.). support services. Routine maintenance of the infrastructure is designed to maintain efficiency and avoid interruptions in service due to breakdowns or malfunction. If an infrastructure requires special measures (due to failure, malfunction, lack of reliability, etc..) the manager contacts the Management and the internal maintenance service, signalling the need to ensure that action is taken to solve the problem. the management and the maintenance department are in charge of the definition of the frequency of intervention, methods of execution and verification of maintenance for both infrastructure and the workplace. Working environments have been analyzed in detail within the Environmental Analysis (for environmental aspects) and the Company risk assessment document (for issues related to IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 48 of 80 health and safety at work). Finally, they were also analyzed for the aspects relating to the SA8000 (with specific focus on the points of the standard 3.7, 3.8 and 3.9). It is also recalled how BIFFI ITALIA is attentive to the aspects of energy consumption keeping reduction as a priority objective. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 49 of 80 7 PRODUCT DEVELOPMENT This section discusses the third macro-process defined by the standard UNI EN ISO 9001:2008 for the activities related to the implementation and delivery of products and services and includes similar requirements of the standard UNI EN ISO 14001:2004 and BS OHSAS 18001:2007 and the standard SA8000: 2008. These activities include various processes from order management, to design to service provision (with ancillary processes such as the identification of products and services and equipment management - Work and measurement). This is described in the paragraphs of this section, keeping the index proposed by UNI EN ISO 900. There are two principal realization processes identified by BIFFI ITALIA and they are defined "Construction Contracts Development" and "New product design." The first process indicated is headed by the realization of the actuator according to Customer requirements. In response to a client request according to its specifications, BIFFI ITALIA evaluates products already made and suggests one or more solutions: these are solutions that do not alter the characteristics of the product, and thus do not require a real design process. If accepted by the Customer, the request is transformed into an actual contractual document which, in turn, is transformed into a final product delivered to the Customer. The other process is the design of a new actuator or a new series of actuators. Depending on the demands of the market, new technologies and technical developments toward particular solutions may require the need to develop a new series of actuators, for this purpose all the mechanisms start that lead to the drafting of specifications, then preliminary projects followed by the realization of prototypes and finally, after the necessary fine-tuning, the launch of the product on the market. 7.1 Product Planning and Development BIFFI ITALIA defines in the main order management process all the activities related to the planning of product development, taking into account, as applicable: quality objectives; compliance with regulatory requirements relating to product manufacturing, the environment, health and safety at work and social responsibility; product requirements; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 50 of 80 need to establish documents and processes, as well as dedicated resources, methods of verification, validation, monitoring, inspection, testing specifications and corresponding acceptance criteria and recording procedures. In particular, for services provided the Company: identifies the processes that contribute to the proper implementation of the product and their interactions; establishes the stages of each process required to develop the product and obtain the desired result; verifies the feasibility of the processes; identifies the risks associated with the activities and processes required to develop the product and the possible environmental impacts; defines the procedures necessary to prevent the risk of incidents both for their staff and for any suppliers, sub-suppliers and sub-contractors; defines the possible environmental impacts and identifies the consequent actions to prevent or minimize these impacts; defines the criteria for monitoring necessary to ensure conformity of the product/service; identifies the Personal Protective Equipment (DPI) and plans the necessary training for the proper use of the same; determines and implements means to monitor processes so they provide the planned results over time. ensures the availability of data and information to effectively support activities and monitoring of processes and the definition of possible improvement actions. maintains as records the results of the monitoring of processes and the services provided as evidence of effective implementation and monitoring of processes and services and of their conformity with the technical and contractual specifications as well as statutory and customer requirements. It is highlighted how appropriate quality plans for orders that need to be carried out can be developed upon request by the functions involved, or when provided for by contract. Appropriate reference instructions are provided to support such activity. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 51 of 80 7.2 Processes related to the parties involved The business processes are carried out in compliance with the implicit or explicit requirements of parties concerned, with particular attention to: Public Administration and Control Bodies; customers (buyers and conferrers); local population; company personnel. In order to ensure full compliance with the requirements BIFFI ITALIA: monitors applicable laws keeping the relevant record documents updated; verifies compliance with all regulatory requirements relating to product manufacturing, the environment, health and safety at work and social responsibility; identifies the technical specifications of processes/products contained in agreements/contracts with Customers, monitoring processes and measuring the merchandise quality of the products; identifies the environmental aspects that can cause trouble or danger to the local population; identifies risks to which workers are exposed by keeping the risk assessment Document duly updated; identifies applicable aspects of social responsibility. With specific reference to aspects of the quality of the product, BIFFI TALIA, through the Sales function, identifies the requirements specified by the Customer, those necessary for the use of the actuator, statutory and regulatory requirements applicable to the product, as well as any other components necessary to the definition of contracts during Sales negotiations. The Sales function involves, where appropriate, other services, generally ENG, in order to obtain technical support for the accurate definition of requirements. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 52 of 80 When the order is received from the Customer, the sales office assesses it in order to resolve any inconsistencies or inaccuracies that should be detected and draws up a document for this purpose to certify the review of the product requirements. This document is the input data for the ENG to start the customization of the actuator. Activities after delivery, such as warranty service, maintenance or additional services, are indicated in the maintenance manuals of the products. Further details on how to manage contracts, sales policies, assessment of requirements and the involvement of the other functions of the Company are provided in the description of the management process of orders and support instructions to Sales. The review ensure that any stated customer requirement is compatible with the Ex certificate e.g. equipment group, temperature class, type of protection, EPL and ambient temperature range. 7.3 Design and development This paragraph describes the organizational criteria adopted by the Organization to monitor planning and development in accordance with the needs and expectations of Customers as well as technical specifications and applicable regulations. As much as possible and depending on the type of design activity, said activity is carried out taking into account environmental and safety aspects and tending to minimize the risks involved. 7.3.1 Design and development planning The start of the design of a new actuator can be done at BIFFI TALIA through an explicit request by the Customer, or in response to a request from marketing that within the Group identifies a market need. At this point resources are assigned, the main stages of design and development, the moments of review, the procedures for verification of the actuators are defined; the procedures for validation are also agreed on and finally the responsibility and authority for planning and development are decided. The schedule is updated with the progress of activities. More details are available in the procedure P-SGQ-04 and in the applicable instructions. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 7.3.2 IMSM rev. 9 of 02.02.2015 page 53 of 80 Design and development input elements The design input elements of BIFFI ITALIA are contained in the "General specifications" that contain the requirements that the new actuator will have, this document has been developed within the Group and reports the technical and functional requirements, the instructions related to the statutory and regulatory requirements applicable and anything else needed to start the business. In particular, the input elements of the design and development process are divided into external and internal input elements and involve awareness of the following parameters: 7.3.3 External input elements Customer needs and expectations assessed by careful examination of requirements Applicable binding modifications to the requirements National and international technical Laws and Regulations Requirements for safety Requirements relating to environmental impact. 7.3.4 Internal input elements Competence requirements for the personnel carrying out the design and development Feedback information from past experience Records and data on existing products and processes General items related to the product The head of planning within the group ensures that the design input data is reviewed and verified in order to verify the adequacy and resolve any ambiguities contained therein. For all projects/products that need to take account of European Directives (PED, ATEX) the Design draws up and, if necessary, submits a calculation dossier to the Body notified, based on the requests received. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 7.3.5 IMSM rev. 9 of 02.02.2015 page 54 of 80 Design and development output elements Design and development output elements include bills of materials, designs, specifications, plans, manuals of operation and maintenance, including any details for the storage of the product, as well as all the specific installation, testing, commissioning work and whatever is identified as a requirement of the actuator for proper use, in terms of specifications and safety, as well as compliant with environmental requirements. These documents that have been developed throughout the design activities are assessed and tested to ensure they meet the input requirements for design, are adequate to provide all the necessary information for procurement, production and service provision, recall the acceptance criteria of the actuators themselves and clearly identify the scope of proper, safe use. 7.3.6 Design and development review In planning the design information can be found on review activities, which, conducted in a cross-functional way, generally under the responsibility of the design, allow assessing design and development abilities to meet the requirements. 7.3.7 Design and development verification The verification of the design, according to the plans, is conducted through a series of trials and tests in order to ensure that the design and development output elements are consistent with the relevant input requirements. All findings and follow-up actions are recorded in order to assess the development of consequent actions. 7.3.8 Design and development validation Once development stages are complete and after validation of the design, which gives rise to the release of the final documentation, the Management of the Group authorizes the launch of the product on the market. 7.3.9 Monitoring design and development modifications In the launch phase of the product on the market performance of the same are constantly monitored through contacts with Customers who use the product, if necessary the appropriate investigations are undertaken, both from the sales functions and by Management and the Group that may result in reviews of the design to make changes to the product, if the need has been underlined. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 55 of 80 Modifications are always managed by the ENG that will assess, in cooperation with other functions, with the management and the heads of the Group whether or not to initiate a new project. If the need for special interventions is not identified, rather the need to initiate changes to the project already validated, new activities will be determined by ENG, as applicable, for review, verification and validation. 7.4 Procurement BIFFI ITALIA ensures that products supplied comply with the proposed application and also defines monitoring procedures both in terms of the supplier and the purchased product. The QA is responsible for the supplier qualification in BIFFI ITALIA that tests their ability to supply products in accordance with the requirements, through assessment of their quality system and analysis of samples and pre-production, before deciding on their introduction into the list of qualified suppliers. The "Vendor List" is an electronic document verified by QA and ACQ, and used to monitor the performance of the supplier and the subsequent renewal of the qualification. As regards the methods of procurement, issue and approval of orders, requirements to identify both for products and personnel, please refer to the appropriate instruction on support to the activity. BIFFI ITALIA verifies the purchased product using a special procedure that takes into account the documentary requirements that goods must meet on arrival at the Plant, any certification with the products, the quality level of the previous supplies, sampling of products, in order to assess the conformity of the incoming lots. Suppliers are classified by product families and those that provide special processes, in outsourcing and that are critical in terms of ATEX/IECEx and PED are subsequently identified. For each category the criteria for the qualification are defined and through the Vendor Rating the performance of supplies is monitored. During the contract phase, all suppliers are informed of any requirements of BIFFI ITALIA regarding safety, environmental and social responsibility requirements. If necessary, procedures, instructions and/or related technical specifications are delivered to the supplier, in a non- controlled way, to provide the offer and in order to subsequently perform the work covered by the contract. In addition, the contractual requirements, in particular for construction and maintenance contracts, include compliance with the requirements of laws relating to safety, in particular those indicated in Legislative Decree IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 56 of 80 no. 81/2008 and subsequent amendments and compliance with environmental regulatory requirements (Legislative Decree 152/2006 and subsequent amendments). 7.5 Service development and provision 7.5.1 Monitoring production and provision of services BIFFI ITALIA plans production activities depending on as contractually agreed with the customer. The ENG, once the contract documents are received from PMO, shall initiate the study and customization of the actuator, thus completing the Engineering BOM (Bill of Material) of the actuator. During completion of the customization of the actuator, depending on the production schedule and deliveries agreed with the customer, procurement of products with orders to suppliers can be initiated, following the indications in the chapter on supply; or activities can be initiated to internally implement the parts to be assembled. In this second case the Manufacturing Engineering identifies the most appropriate equipment and verifies the availability of instructions, control plans or other in order to ensure conformity of the parts produced. In addition, with the support of QA, all the activities of monitoring and measurement deemed necessary for the fulfilment of contractual requirements are put in place. Once the codes are acquired, they are loaded in the warehouse, thus making them available for subsequent assembly and testing. The production planning office can operate in three different ways: acquisition, internal construction, processing acquisition (Subcontracting). Acquisition of details occurs by batch or individual parts according to requirements. The services/processes that are complementary to production are as follows: Support services including responsibilities related to personnel (HR), the environment and health and safety at work (RSGI and RSPP); Administrative service; Integrated Management System Service (RSGI and ASGI); control process for measuring and monitoring (including equipment and devices); process of resource management; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 57 of 80 control process of documentation and records; process of assessing Customer satisfaction; process of managing Internal Audits; process of managing non-conformity of the Corrective and Preventive Action; internal communication process; data analysis process; Management review process. BIFFI ITALIA provides procedures, production equipment, working environments and inspection/testing facilities that together provide assurance with respect to the compliance of the product with the type as described in the Ex certificate. 7.5.2 Operational monitoring BIFFI ITALIA identifies the activities and operations that are deemed essential for the protection of the environment and the protection of health and safety at work, in order to provide for their control through appropriate tools provided by the SGI. BIFFI ITALIA plans these activities, including maintenance of equipment and instruments, in order to ensure that they are conducted under prescribed conditions. In particular, BIFFI ITALIA plans the operational monitoring in relation to all significant environmental aspects and operational risks. To achieve this purpose, it is necessary to: define appropriate operational criteria within procedures, which take into account any regulatory requirements; establish and keep procedures and/or documented work instructions updated, to prevent situations where the lack of such procedures/instructions could lead to deviations from the requirements of the SGI; communicate to suppliers and contractors procedures and requirements pertaining to them. To this end, BIFFI ITALIA has prepared a special procedure PGI-09 "Operational control and Emergency Management" to which various Procedures and operating instructions are IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 58 of 80 attached that ensure the proper management of activities associated with the significant environmental aspects and company risks. 7.5.3 Preparing for emergencies and reaction BIFFI ITALIA establishes and maintains active the procedure PGI-09 Operational control and emergency management, in order to ensure the identification and monitoring of potential emergencies through intervention plans that are able to: adequately respond to potential incidents and emergency situations; prevent or mitigate the consequences of incidents and emergency situations that may occur regardless. The procedure applies to the: definition of responsibilities and procedures for the detection of emergencies; definition, preparation, review, approval and periodic simulation of the "Plan of emergency and evacuation." The procedure, operating instructions and the Emergency Plan should be periodically reviewed in the Management Review and in any case after the occurrence of an emergency or in the event of significant changes for the purposes of security in business processes. 7.5.4 Validation of processes for production and provision of services The production processes whose outcome is not verified by subsequent monitoring or measurement are welding and painting. Specific instructions include the criteria defined for the review and approval of these processes, the approval of the equipment and the personnel involved, the procedures and instructions for the execution of these processes, the procedures for their registration and revalidation, as well as any third-party entities desired by BIFFI ITALIA or the Customer to certify the conformity of the validation of the processes and operators. With regard to thermal and surface treatments, these are treated as outsourcing and managed through the applicable documents. For ATEX/IECEx requirements, where a process can affect the integrity of a type of protection, and where the resulting integrity cannot be verified after manufacture (e.g. the environmental conditions required for curing an encapsulant), that specific process is measured or monitored and documentary evidence is maintained to demonstrate compliance with required parameters. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 7.5.5 IMSM rev. 9 of 02.02.2015 page 59 of 80 Identification and traceability BIFFI ITALIA identifies all the products within the production cycle by means of markings on the same, when expected, or identification codes on the packaging of the products. Where traceability is an explicit requirement of the Customer BIFFI ITALIA monitors components and products with associated records. 7.5.6 Customer property The properties of the Customer which may be found at BIFFI ITALIA are actuators being repaired that are identified as described in the specific procedures or instructions of reference. Specifications or technical specifications or documentation that the Customer sends to BIFFI ITALIA to support the construction contract are handled and stored in accordance with the rules established by the PMO service and can be found in the instructions. Such documentation shall be retained for the duration of the contract for those directly responsible and involved in the activities, and shall not be returned unless explicitly requested by the Customer at the end of the contract. It is the responsibility of BIFFI ITALIA to verify the compatibility of the customer supplied product with the requirements of the Ex certificate. 7.5.7 Product storage All products are stored and managed so as to prevent damage. There will also be different handling, packaging, storage and delivery procedures in relation to the specifications of each Customer, for further details please refer to the instructions on the support activities. 7.6 Monitoring control and measurement devices The QA function has identified and managed all monitoring and measurement equipment of the products required to provide evidence on the conformity of the products with respect to certain requirements, in consultation with the manufacturers' manuals and technical industry publications, identifying the type of measurement, the fields and the tolerances allowed, and making a choice of tools to use. The purchase of these instruments is managed by QA in collaboration with management and the responsible Entities. All the measurement devices are managed through a specific software concerning the calibration checks, the schedule, the reference to instructions and/or verification IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 60 of 80 procedures, the use of samples with related metrological chain, the use of accredited laboratories for performing calibrations. In addition, the devices are identified so that their calibration status is known and protected by regulations which may affect the measurement results. If an instrument is out of calibration (also during periodic inspection) validity of the checks carried out with the instrument calibration is assessed and any corrective action is taken if they are unacceptable (repeat controls, notice to the Customer, etc.). Moreover, the appropriateness of software used for measurements is also verified, through verification of their configuration. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 61 of 80 8 MEASUREMENTS, ANALYSIS AND IMPROVEMENT The following section of the SGI Manual deals with the procedures by which BIFFI ITALIA manages the activities related to the fourth macro process defined by UNI EN ISO 9001 and incorporates the relevant applicable requirements defined by the standards OHSAS 18001, SA 8000 and UNI EN ISO 14001. 8.1 General Information BIFFI ITALIA has defined, planned and enabled measurement, monitoring, analysis and improvement to ensure that the SGI and the business processes and services comply with the provisions of the Corporate Policy and related objectives and allow providing services that meet the requirements of Customers. To this end, the critical issues and the related objectives have been identified for the processes and the services provided, in order to have indicators that can measure effectiveness and efficiency for each of them. In addition, to monitor the entire SGI, internal audits are planned, designed and executed by the RSGI. The results of the analysis of data obtained from monitoring of processes and services, from the Audit Reports, non-conformities and complaints, incidents, emergencies, assessments of risks related to safety, health and environment, the investigations on the degree of customer satisfaction, the corrective and preventive actions and initiatives aimed at improvement are assessed periodically within the Management Review and at the end of the presentation by RSGI of the Report on the State of the Integrated System. The review by the DIR is the appropriate time for data analysis and the definition of improvement actions. In terms of quality, the parameters available to the Company for the assessment of activity progress are internal indicators related to: complaints received from customers; non-conformity analysis of products and services; analysis of corrective and preventive actions taken; analysis of the number and type of changes / contract changes that occurred in the course of work; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 62 of 80 sales analysis and sales trends; Customer satisfaction; monthly reports on trends in the activities of each sector (monthly report). During the review of the SGI by the Management, parameters to be monitored and measured in order to control the performance of business activities are identified by the same management and QA with the express purpose of: verifying and ensuring compliance of processes, products and services; ensuring compliance of the SGI; having elements to continuously improve the SGI. As regards, however, the monitoring of the integrated management system, BIFFI ITALIA establishes and maintains active documented procedures to monitor and measure regularly the main characteristics of the activities and operations that can have a significant impact on the environment and to monitor and measure on a regular basis performance in terms of health and safety and social responsibility. BIFFI ITALIA establishes and maintains active procedures whose purpose is to ensure that the following are carried out periodically: checks on the state of progress of the implementation programs of the respective Goals & Objectives (performance verification); verification of compliance with laws, regulations and directives. recording the information needed to verify the performance, operational controls and compliance with the objectives and targets set. reactive performance measures to monitor the non-conformities, incidents, injuries, hazards and similar historical evidence of non-fulfilment; plan and perform the maintenance of surveillance equipment. BIFFI ITALIA has prepared a special procedure ensuring the proper management of monitoring and measurement PGI-10 "Managing the monitoring plan." IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM IMSM rev. 9 of 02.02.2015 page 63 of 80 INTEGRATED MANAGEMENT SYSTEM MANUAL 8.2 Monitoring and Measuring 8.2.1 Customer satisfaction At the regular meetings, Client information concerning satisfaction of product delivered and service provided and general comments, complaints and suggestions, is collected and discussed. The outcome is used to make improvements to company services and subject to specific monitoring. Such monitoring is provided in the subsequent regular meetings and during management reviews. The QA and DIR function, with the CdD, as part of the Management Review, define the business ratios that, properly calculated and monitored are used to assess how the company meets the demands and needs expressed and implied by its customers. To define the parameters that contribute to the considerations are required on the following aspects: Customer satisfaction some correspondence of our products to the needs required; product conformity; service accuracy; communication quality. To assess customer satisfaction and identify the necessary interventions it should be remembered that: Customer satisfaction is an ongoing process; it is necessary to provide the customer with a communication process that acts as a strong element of retention and training of its staff. The QA is responsible for the demands of the Management to that effect and stimulate the various functions involved in the collection of data required from time to time in order to assess Customer satisfaction. The results of the analysis are reported in the form of percentage tables and possibly on graphs (ex. Criticality Matrix) to allow overall statistical analysis. The QA function examines and reports to DIR the performance of these indices and shall solicit the necessary action to improve the degree of satisfaction expressed by the Customer. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 8.2.2 IMSM rev. 9 of 02.02.2015 page 64 of 80 Internal Audit BIFFI ITALIA performs internal audits planned in order to monitor the SGI, to ensure that it is implemented in accordance with the applicable standards and the company's policy, and that it is effectively implemented and maintained to achieve the objectives set by the Management. A series of audits is planned that take into consideration the status and importance of the activities concerning Quality, the Environment, Business risks (occupational health and safety) and Social Responsibility, as well as the results of previous Audits. As regards Quality, the QA function plans internal audits according to the criticality of the business areas, the anomalies found in the area, any complaints received by customers. All business functions are, however, subject to verification at least once a year. To conduct the audit, QA may use "checklists" that allow no verification point to be omitted and recording objective evidence found. The "checklist" duly completed, or the final report shall be signed by the participants of the audit (auditors and audited) for acceptance of the results of the audit. Criteria, scope, frequency and methods of audits are established. The results of the audits are documented through appropriate records that shall be communicated to the functions audited. In view of the shortcomings found, adequate remedial action is readily taken in accordance with the procedure PGI-12 "Internal audits". The implementation and effectiveness of the actions taken is determined in subsequent audits and properly recorded. The choice of Auditors and conduct of Audits shall ensure objectivity and impartiality of the audit process. The Auditors do not conduct audits on their work. 8.2.3 Monitoring and measuring processes 8.2.4 Aspects related to quality Monitoring of the realization process parameters necessary to meet the requirements of the customer, when necessary, is provided in the SGI documents The methods employed confirm the ability of the individual processes to achieve planned results. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 65 of 80 The processes of monitoring compliance with the criteria for the acceptability of products/services, procurement processes and those of domestic production are described in the specific flowcharts within the procedures and instructions mentioned in this manual. Monitoring activities for the preparation of the goods is carried out by operators in selfcontrol to ensure the integrity of the activities and their compliance with the specified requirements. The work and monitoring are executed when the relevant documents have been checked and signed thus allowing the traceability of the operations and inspections conducted. All checks and verifications performed during and at the end of the production processes are carried out in accordance with appropriate Operating Instructions or regulations. If abnormalities are detected, these and the processing are recorded in the software for the management of non-conformities. 8.2.5 Assessment of compliance with provisions BIFFI ITALIA establishes and maintains a documented procedure PGI-03 Management of legal requirements for periodic assessment of compliance with applicable legal requirements and all requirements that BIFFI ITALIA signed. The periodic assessments are stored by the RSGI. 8.2.6 Monitoring and measuring products Monitoring and measurement of products is implemented at BIFFI ITALIA through the execution and recording of the tests throughout the realization cycle in order to ensure compliance with customer specifications. The trials, inspections and tests on products are performed starting from the entrance of the purchased product as described in the appropriate reference procedures. The product is then controlled during the phases of assembly and final checks are then performed before the release of the product. When specifically requested by the customer checks can be performed by third-party bodies or by the Customer or its representatives. Otherwise, the QA organization is responsible for the final release of the product, in the case of a dispute it is QA responsibility to ensure that the customer can receive the product anyway accepting a request for a grant. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 66 of 80 8.3 Managing non-conformity The activity is conducted as required by the procedure P-SGQ-01, in general the procedure provides the following operational methods. Anyone within the company is responsible for identifying and reporting anomalies and non-conformities identified: on materials and products: identification anomaly as to make the use uncertain or doubtful, incorrect coding, damage, damaged or expired products, usage over the period of the warranty, etc.; on the SGQ: non-compliance with the rules and provisions contained in this manual and in the specific Operating Instructions, errors and inaccuracies in the specific Operating Instructions, documentation not updated or not available, omitted or incomplete records, etc.; following notification of the Customer: anomalies can be reported regarding the products used following an installation or delivery to the final customer, the assessment of the damage and the possible replacement is subject to evaluation by the technician sent by the manufacturer; anomalies of machinery and means: malfunctions, failures from the point of view of safety, overheating, etc. Those who have detected the non-compliance is responsible for identifying and secluded it, as applicable. The QA function shall analyze non-conformities reported and consult relevant company functions concerned to identify the actions to be taken and the manner and timing of application. Following the analysis of the causes of non-conformity, for particularly severe or recurrent non-conformity QA may request the departments concerned to take corrective action aimed at eliminating the source of the cause of non-conformity to avoid recurrence. 8.4 Data analysis To verify the adequacy and effectiveness of the management system and to evaluate its improvement a constant analysis of data collected during the monitoring of the various business processes is done. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 67 of 80 This analysis provides the information necessary to assess: Customer satisfaction; conformity of the products to the specifications; characteristics and trends of processes and products; situation of suppliers; monitoring of measurable indicators defined by the Organization. This data, which defines the indicators of the SGI, contribute to the evaluation of the effectiveness and efficiency of business processes and opportunities for preventive actions for the improvement of the same. 8.5 Improvement 8.5.1 Continuous improvement The continuous improvement process is based on the improvement objectives assigned to the Departments by the Management during the review of the SGI. On a monthly basis, with regard to the issues of quality, meetings are formalized for the analysis of the company performance, for which an update is reported in a folder (Strategy Deployment), which is shared with all the department heads, and where expected Improvement Plans are recorded. 8.5.2 Corrective actions If identified, at any stage of the production process and based on controls, situations that do not conform to the provisions of the SGI, the procedure PGI-11 Managing nonconformities is implemented. The company functions under the authority of which the non-conformity is identified, are responsible for: defining the resolution of the non-conformity; verifying the implementation of the resolution; analyzing data of anomalies to identify the causes of non-conformity; proposing possible corrective and preventive actions of broader impact. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 68 of 80 Non-conformities detected are kept for statistical purposes to implement corrective and preventive actions for continuous improvement of environmental business performance. Corrective actions are taken to eliminate the causes of existing non-conformities, defects or other undesired situations in order to prevent recurrence. The responsibilities and procedures for implementing corrective actions are described in detail in the procedure PGI-15 Corrective and preventive actions. This procedure involves: a) review of non-conformities; b) research into the causes that led to the non-conformity on the SGI, c) definition of the corrective actions necessary to eliminate the causes of nonconformity and appropriate to the magnitude of problems and commensurate with the risks involved; d) implementation of corrective actions; e) recording the results and effectiveness of the actions taken and subsequent updating of the corporate procedures for changes to the SGI. f) review of the results of corrective actions and the information to the management (input to the review of the SGI). The documentation concerning corrective actions implemented is stored in accordance with the provisions of the reference procedure. 8.5.3 Preventive actions Preventive actions are taken to eliminate the causes of potential non-conformities, defects or other undesired situations in order to prevent occurrence. The responsibilities and procedures for implementing preventive actions are described in detail in the procedure PGI-15 Corrective and preventive actions. This procedure involves: a) analysis of the processes and work activities that influence performance; b) determination and implementation of preventive actions; IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 69 of 80 c) carrying out checks to ensure that preventive actions are implemented and effective; d) the documentation in the business procedures of the changes made to the SGI. e) The review of the results of corrective actions and the information toward the Management (input to the review of the SGI). The results of preventive actions are subject to review by the Management. The documentation relating to preventive actions implemented is stored in accordance with the provisions of the reference procedure. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 70 of 80 9 ADDITIONAL ASPECTS OF SOCIAL RESPONSIBILITY 9.1 Child labour 9.1.1 Purpose The purpose of this chapter of the SGI Manual is to define, in compliance with clear indications of Ethics Policy of BIFFI ITALIA, relating to child labour, the procedures and responsibilities identified by BIFFI ITALIA within its operational staff to ensure full compliance with the requirements defined by the reference standard adopted in the field of child labour. Given that Biffi Italia is an Italian company and, as such, observes what is already regulated in relation to the prohibition of child labour in the relevant national legislation (ref. the Italian Constitution Articles 37 and 34; Law 977/67, as amended by Legislative Decree 345/1999 in transposition of the EU directive 94/33/CE; CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS, Art. 6 – Title I – Fourth Section), it is also recalled that the activity of BIFFI ITALIA requires, for the particular matter handled, product and Work places, adult personnel with certain experience, able to work in safety and with good self-control and self-management of workloads. For this reason it is extremely difficult that personnel that fall within the definition of child or young worker can be employed by BIFFI ITALIA. Only in rare cases an internship is allowed to for minors in order to make them aware of the working world, in accordance with the applicable binding regulations. 9.1.2 Introduction The present Chapter is indicated in reality for the sole purpose of completeness of the provisions related to the company with respect to the Standard SA8000 as BIFFI ITALIA: never employed personnel that could be defined as "child" or "young worker" has no intention of employing such workers in the future. To guarantee the actual commitment in implementing a Social Policy aimed at improving the standards of living, BIFFI ITALIA is against the use of children and/or young workers and does not even take in consideration the remote possibility of employing them. In the case in which BIFFI ITALIA you entrust subsections to suppliers that use to their young inside workers or verified l' existence I press third suppliers of an of the situations under listed, would have been opposed to their utilization, activating itself for the they recover. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 9.1.3 IMSM rev. 9 of 02.02.2015 page 71 of 80 Opposition to the use If BIFFI ITALIA, during the initial assessment or subsequent monitoring of its suppliers identified the use of child labour, remedial and/or corrective action would be implemented in accordance with the procedures of the management system. The nonuse of child labour by a supplier is one of the basic conditions for the maintenance of a contractual relationship with the supplier. If this type of labour were identified, BIFFI ITALIA would promote an improvement plan aimed at eliminating the problems noted. 9.1.4 Use of children or young workers In the exceptional case in which employees are young students in internship courses at the company, subject to the limits provided by law, every precaution is taken to safeguard their health and safety. 9.2 Forced labour 9.2.1 Purpose The purpose of this chapter, in accordance with the desire expressed by BIFFI ITALIA, is to demonstrate that the staff employed at BIFFI ITALIA does not work, nor will ever work for corporate conviction, under conditions of forced labour. Never, even in the future, will this ever happen and to establish this principle, this chapter and the related procedure have been provided. 9.2.2 Introduction Given the scope of operating of BIFFI ITALIA (both in terms of geographical allocation and in terms of type of activity) it seems superfluous to point out that it is never absolutely required to leave money deposits or identity documents upon start of the work relation (subject to the declarations, any copies of documents, and/or certifications required to proceed with communication relating to recruitment). Provided the provisions above, we wish to emphasize the voluntary nature of the actions of the staff of the different case studies. Neither the company nor any other entity that provides work to the company retains part of the wages of the staff, benefits, property or documents and uses them in order to force the staff to continue to work for the company. 9.2.3 Overtime The procedures by which staff is required to carry out overtime work are defined in full respect of METALWORKER INDUSTRY AND INSTALLATION OF PLANTS in force, applicable to IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 72 of 80 the Organization (ref. Art 7 - Title III - Section Four). Notwithstanding as regulated within the CCNL mentioned, Biffi Italia, together with the Union Representatives, has established, in a Supplementary Company Agreement still in force, a more favourable remuneration as payment of overtime. 9.2.4 Holidays and leave Given as defined in the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS in force regarding holidays and Leave (ref. Art 10 Title III and Article 13 Title VI - Section Four), BIFFI ITALIA also in the organization of holidays leave their employees the freedom to organize their holidays and take advantage of work leave, previously communicated to Managers in order to allow proper organization of work activities 9.2.5 Penalties Penalties may be applied to the staff, but only for carelessness of the staff regarding the requirements established by the applicable National Collective Labour Agreement applied at BIFFI ITALIA and/or the requirements documented in this manual and in the documentation relating to health and safety in the workplace. These penalties are always given in full compliance with the provisions of the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS in force (ref. Articles 7, 8, 9, 10 and 11 – Title VII – Section Four). 9.2.6 Loans At BIFFI ITALIA loans are not issued to its employees, subject to any requests for advance on their TFR (severance pay), and as regulated by CCNL Metalworker Industry and Installation of Plants (ref. p. 775 ref. L. 29 May 1982 no. 297). The provision of a possible advance of severance pay to the employee will not affect in any way the freedom of any employee including that of submitting resignation from work. 9.2.7 Health and Safety The purpose of this chapter is to highlight that BIFFI ITALIA meets the aspects of analysis and assessment of all occupational health and safety risks, considering them of primary importance. As required by Legislative Decree no. 81/2008 and subsequent amendments, BIFFI ITALIA, has carried out and implemented all the provisions concerning the protection of workers concerning occupational health and safety. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 73 of 80 In addition, this Manual, and documents concerning the management and recording, conforms to BS OHSAS 18001:2007 (BIFFI ITALIA is certified by accredited body even for the technical regulation cited above). 9.3 Freedom Of Association And Right To Collective Bargaining 9.3.1 Introduction Within the geographical area in which BIFFI ITALIA operates there are situations in which the right to freedom of association and collective bargaining are prevented, thanks to the national legislation and the work of public control bodies (ref. CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS in force, p. 743, ref. L. 20 May 1970, no. 300, Workers' Statute). 9.3.2 Collective Bargaining BIFFI ITALIA, as described in other sections of chapter 9 herewith applies in the conduct of contractual relations with all its employees the management guidelines and requirements set by the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS in force and all the requirements established by the binding law applicable for contractual relations with employees. 9.3.3 Freedom of association At the time of preparation of this document at BIFFI ITALIA, there are union representatives for workers. The company effectively informs personnel regarding the freedom to join any organization, without their choice entailing any negative consequences or leading to retaliation by the company. 9.4 Discrimination 9.4.1 Purpose The purpose of this Chapter is to outline the principles and methods of managing relationships with internal staff, as well as the related responsibilities, in order to ensure that actions are implemented aimed at the discrimination of the personnel of BIFFI ITALIA. This Chapter takes into account the stages of recruitment, hiring, promotions, disciplinary procedures, assignment of salary increases, access to training, dismissal, retirement in order to demonstrate that in none of these steps are discriminatory actions implemented based on race, caste, national origin, religion, disability, gender, sexual orientation, union membership, political affiliation, age, and type of contractual relationship. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 74 of 80 In view of the analysis of reference documents (CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS and applicable legal requirements) and SA8000 it was verified that the former is more restrictive than the latter. This chapter also describes the way in which any personnel employed by the organization with a temporary contract work (temporary work) is managed, that is the use of workers not directly hired by the company, but by authorized body for the supply fixed term labour. 9.4.2 Definition of competences The Management has defined, and periodically updates, the skills necessary for people to carry out the functions and roles required by the organizational structure. 9.4.3 Personnel recruitment The recruitment of new staff, based on the needs highlighted by the Management, takes place in accordance with local regulations (ref. CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS, Title I, Section Four, Legislative Decree 26 May 1997, no. 152). For everything related to the staff recruitment and hiring process, please refer to as better defined in the HR Procedure, rev. 1 of 01/02/2013). 9.4.4 Definition of the initial salary It is the responsibility of the Management to establish the initial salary of new employees, based on the assigned tasks and their profiles and tables listed in the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS in force (ref. Title II and Title IV Section Four) 9.4.5 Definition of the trial period The Management shall establish, on the basis of the regulated CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS in force, the trial period of the employee hired by the company (ref. Art. 2 - Title I - Section Four). 9.4.6 Training The procedures for managing training are such as to ensure that employees have access to training, as evidenced by the Training needs analysis conducted annually by the HR together with company managers. For all matters regarding the issue of training in the company reference is made to as outlined in further detail in the HR Procedure, rev. 1 of 01/02/2013). IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 9.4.7 IMSM rev. 9 of 02.02.2015 page 75 of 80 Organization of overtime The management of overtime shall be such to ensure that, on the basis of exceptional and contingent circumstances of the organization, employees and their managers may agree on the need to perform, in cases of special need, overtime activities, or run over the daily work schedule. For all matters regarding the organization and regulation of overtime, please refer to as regulated within the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS and second level internal bargaining (ref. Art 7 - Title III - Section Four). 9.4.8 Organization of holidays Holidays are organized on the basis of requests from individual workers, with a program by the official authorized to do so by the Management, each within their own area of competence, upon consultation with the department heads by the worker (line/service/office). The program is designed to not force, in such contingent moments, the remaining staff to work overtime or in emergencies (within the existing structural limits). For all matters concerning the regulation of staff holidays, please refer to CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS in force (ref. Art 10 Title III and Article 13 Title VI - Section Four) 9.4.9 Dismissal The dismissal of an employee by BIFFI ITALIA can be determined and implemented exclusively on the basis of legal and contractual regulations that specifically regulate this aspect. By the rules documented, it is clear to all staff that no redundancies are implemented based on discriminating elements of a person. (Ref. Article 10, Title VII Section Four - CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS). 9.4.10 Retirement The retirement of an employee by BIFFI ITALIA is managed in full compliance with the current requirements in regard without this ever being subject to factors related to the individual. 9.4.11 Freedom of exercise of the rights of the person The Management of BIFFI ITALIA allows any employee/collaborator to practise all the activities related to the exercise of the personal right to observe principles or practises or to meet needs relating to race, caste, national origin, religion, disability, gender, sexual orientation trade union membership or political affiliation. This freedom, however, is bound, of course, by full compliance with the requirements of all staff working and the guidelines established by binding legislation. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 76 of 80 9.4.12 Personnel protection Any behaviour and/or activity and/or language that can result in a: threat; offence; coercion; exploitation. of any kind and nature, are managed in accordance with the applicable requirements (according to CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS and binding applicable documentation) for the administration of disciplinary procedures. 9.4.13 Interim labour It is the faculty of BIFFI ITALIA to recruit personnel through companies providing temporary labour. Such organizations (chosen, evaluated and monitored according to the requirements of SA8000) are all in possession of a valid authorization for the conduct of the business of providing temporary work as required by Italian law on the subject. The arrangements for the management of this category of workers are the same as analyzed by the workers directly hired by the Organization in such a way as to allow an immediate verification of compliance with the requirements referred to in this Chapter in respect of any discrimination. Contractual relationships with this type of workers are managed according to current regulatory requirements. 9.4.14 Protected categories Biffi Italia acts in a manner not defined within the provisions of law in force regarding the targeted placement of the protected categories and rules for the right to work of disabled people (ref. Law 12 March 1999, no. 68). 9.5 Disciplinary procedures 9.5.1 Purpose The purpose of this Chapter is, in accordance with the intention of BIFFI ITALIA, which incorporates the principle of equal treatment of its employees, to outline and describe briefly, referring to specific documents clearly identified, the disciplinary procedures in the company that may be implemented at BIFFI ITALIA in accordance with the requirements set by the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS applied to IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 77 of 80 employees in order to demonstrate that punitive methods are never used or supported at the company involving corporal punishment, mental coercion physical or verbal abuse. 9.5.2 General Information The topics covered in this Chapter are by no means exhaustive of all possible cases in regard to events that may lead to disciplinary action as the vastness of this type makes it almost an impossible undertaking. The following section outlines the management methods of the events in such a way that it may become possible to extend to the different cases that may occur related to the recognition of the facts, records and the procedures for solutions. 9.5.3 Type of applicable penalties in agreement with the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS (ref Articles 7, 8, 9, 10 and 11 – Title VII – Section IV) The shortcomings of the worker can be punished, depending on the severity, by: verbal warning, which is in any case registered; written warning; fine of not more than three hours of the minimum hourly wage calculated; suspension from work without pay for a maximum of three days; dismissal with notice; dismissal without notice. 9.5.4 Conduct subject to penalty The failure to observe, on the part of the employee, the provisions of law and of the National Collective Labour Agreement, with particular regard to those relating to the rights and duties and the provisions of services outsource by the company can result, depending on the severity of the offence, in the imposition to the employee of one of the penalties provided for in the preceding paragraph, according to the principles of reasonableness, fairness and progressive measures. It is the obligation of this company to comply with the provisions contained in the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS applied (ref. Articles 7, 8, 9, 10 and 11 – Title VII – Section IV). IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 9.5.5 IMSM rev. 9 of 02.02.2015 page 78 of 80 Rebuttal Any employee subject to disciplinary action, seeking to challenge the legality of the decision, may apply for conciliation procedures provided by law and, in any case, rely on the support of the Trade Unions of Workers 9.5.6 Responsibility and records It is the responsibility of the Personnel Manager to store documents relating to disciplinary proceedings initiated and concluded. 9.6 Working hours 9.6.1 Purpose The purpose of this Chapter is to outline the procedures for managing relationships with internal staff in order to ensure compliance with the requirements expressed by the SA8000 Standard regarding the management of working hours. The purpose of this Chapter is also to point out only some of the existing requirements for managing contractual relations concerning the management of working hours as this area is sufficiently regulated in other documents of external origin (ref. CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS, Title III, Section IV). 9.6.2 Analysis of the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS The CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS, concerning working hours, shall meet the requirements of SA8000 and binding legislation as well as the voluntary standardization. In this document, in fact, provisions are established that require: definition of the working week number of standard hours per work week definition of day/s of rest 9.6.3 Legislation on part-time work In order to regulate the working hours of its staff, BIFFI ITALIA shall also consider the provisions of Legislative Decree no. 61 of 26/02/2001 and subsequent amendments (which regulates part-time work) and to monitor compliance both when defining the agreement with staff and subsequently. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL 9.6.4 IMSM rev. 9 of 02.02.2015 page 79 of 80 Working hours It is the responsibility of the RSGI to verify that the Management, in accordance with the Personnel Manager, subject to the requirements defined by CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS and the mandatory documentation recalled in the preceding paragraphs, in conjunction with the company's needs already expressed in the recruitment phase, establishes the working hours of new employees and univocally communicates it to the same. 9.6.5 Organization of overtime The request to perform work outside normal hours is always carried out with attention to the limitations prescribed in respect of overtime within the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS, Art. 7, Title III, Section Four. The RSGI still has the task of verifying that the Personnel Manager reviews for each employee, overtime for the period under review to verify that it is not necessary to provide for a different planning of resources available. Moreover, the maximum of 12 hours of overtime per week per employee is introduced in compliance with the requirements of the ethics rules. 9.7 Remuneration 9.7.1 Purpose The purpose of this Chapter is to outline how BIFFI ITALIA manages the activities related to the remuneration of its internal staff and the related responsibility to demonstrate full compliance with the requirements in this area as defined by the standard of reference. 9.7.2 Salary The wage determination is carried out by applying the rules contained in the current CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS based on the duties assigned and the related qualification attributed to the worker, which must always be consistent with the profiles and statements contained in the CCNL METALWORKER INDUSTRY AND INSTALLATION OF PLANTS (ref. Title II and Title IV Section Four). 9.7.3 Deductions and readability of the "payslip" The Personnel Manager implements all the necessary tools in order to meet all the needs of employees with regard to readability and understanding of the information given in the pay slip. IMSM Manual Rev. 9 INTEGRATED MANAGEMENT SYSTEM INTEGRATED MANAGEMENT SYSTEM MANUAL IMSM rev. 9 of 02.02.2015 page 80 of 80 To this end, in view of the fact that the pay slip is processed inside the same structure, each employee who notices errors, discrepancies, or simply were not able to understand some of the items listed, has the right to request and timely receive, by the Personnel Office, all the information and explanations required and deemed necessary. 9.7.4 Salary payment procedures Payment of remuneration is disbursed as agreed between the Company and the Trade Unions of Workers, at the beginning of each month (following the month of reference) on day 10. If the 10th day falls on a Sunday, the payment will be on the 11th, and if it falls on a Saturday, the payment will be on the 9th. The employee can choose the mode of payment of remuneration and if the worker does not express a preference payment is ordinarily made by bank transfer on the Institute indicated by the worker. Further to an agreement with the social parties a common shared methodology can be defined and accepted by all workers. IMSM Manual Rev. 9