Manuale Qualità ISO 9000 Ed. 2000 - Biffi
MSGI QHSE MANAGEMENT SYSTEM MANUAL according to standards ISO 9001:2015 ISO 14001:2015 45001:2018 ISO/IEC 80079-34:2018 Rev. 19 del 07/04/2021 This document is property of BIFFI ITALIA S.r.l. and must not be reproduced or disclosed without written authorization from the Management.
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL REV 19 DATE 07/04/2021 DESCRIPTION Added references to ISO 45001:2018 Removed references to BS OHSAS 18001:2007 MSGI Rev.19 del 07/04/2021 page 2 of 43 ISSUED CHECKED G. Fava M. Stoto
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 3 of 43 CONTENTS 0. PROCESSES APPROACH AND RISK ASSESSMENT (UNI EN ISO 9001:2015) . 5 0.1 GENERAL . 5 0.2 INTEGRATED MANAGEMENT SYSTEM FUNDAMENTALS . 5 0.3 PROCESSES APPROACH. 5 0.3.1 General . 5 0.3.2 PDCA . 6 0.3.3 RISK ASSESSMENT – Risk-Based Thinking . 6 0.3.4 RISK ASSESSMENT – Quality . 6 0.3.5 RISK ASSESSMENT – Environment . 6 0.3.6 RISK ASSESSMENT – Health & Safety . 7 1. SCOPE AND SGI APPLICABILITY . 8 2. NORMATIVE REFERENCES . 9 3. TERMS, DEFINITIONS . 9 4. ORGANIZATION CONTEXT .13 4.1 4.2 4.3 4.4 5. INTERNAL AND EXTERNAL RELEVANT FACTORS . 13 NEEDS AND EXPECTATIONS OF INTERESTED PARTIES . 16 APPLICABILITY . 16 QHSE MANAGEMENT SYSTEM REQUIREMENTS AND ITS PROCESSES . 17 LEADERSHIP .17 5.1 LEADERSHIP AND COMMITMENT . 17 5.1.1 General . 18 5.1.2 Customer focus . 19 5.2 INTEGRATED MANAGEMENT SYSTEM POLICY. 19 5.2.1 Policy definition . 19 5.2.2 Policy communication . 19 5.3 ROLES, RESPONSIBILITIES AND ORGANIZATION AUTHORITIES . 19 5.3.1 Environment . 20 6. 6.1 6.2 6.3 7. 7.1 7.2 7.3 7.4 7.5 PLANNING (PLAN – DO – CHECK – ACT).20 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES. 20 SGI OBJECTIVES AND PLANNING TO ACHIEVE THEM . 21 PLANNING OF CHANGES . 21 SUPPORT .22 RESOURCES . 22 COMPETENCE. 24 AWARENESS . 24 COMMUNICATION . 24 DOCUMENTED INFORMATION . 25
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL 7.5.1 7.5.2 7.5.3 8. SGI Manual . 26 Documents and data . 26 Control of documented information . 26 OPERATION .27 8.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.4.1 8.4.2 8.4.3 8.5 8.5.1 8.5.2 8.5.3 8.5.4 8.5.5 8.5.6 8.6 8.7 9. MSGI Rev.19 del 07/04/2021 page 4 of 43 OPERATIONAL PLANNING AND CONTROL . 27 PRODUCTS AND SERVICES REQUIREMENTS . 27 Customer Communication . 27 Definition of the requirements for products and services . 28 Review of the requirements for product and services . 28 Changes to requirements for product and services . 28 DESIGN AND DEVELOPMENT OF PRODUCT AND SERVICES . 28 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES . 29 General . 29 Type and extent of control . 29 Information for external providers . 30 PRODUCTION AND SERVICE PROVISION . 31 Production and services provision control . 31 Identification and traceability . 31 Customer or external providers’ properties . 32 Preservation . 32 Post-delivery activities . 32 Control of changes . 32 PRODUCTS AND SERVICES RELEASE . 32 CONTROL OF NONCONFORMING OUTPUTS . 32 PERFORMANCE EVALUATION .33 9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION. 33 9.1.1 General . 33 9.1.2 Customer satisfaction . 33 9.1.3 Analysis and evaluation. 34 9.2 INTERNAL AUDIT . 34 9.3 MANAGEMENT REVIEW . 35 9.3.1 General . 35 9.3.2 Management review input . 35 9.3.3 Management review output . 35 10. IMPROVEMENT .36 10.1 GENERAL . 36 10.2 NONCONFORMITY AND CORRECTIVE ACTIONS . 36 10.3 CONTINUAL IMPROVEMENT . 37 ATTACHMENT 1: CORRESPONDENCE AMONG THE STANDARDS ISO 9001, ISO 14001, ISO 45001 AND ISO/IEC 80079-34 . 38
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 5 of 43 0. PROCESSES APPROACH AND RISK ASSESSMENT (UNI EN ISO 9001:2015) Biffi Italia (hereinafter “the Company”) has updated, redesign and implemented its own Integrated Management System in compliance with the new references mentioned above in the cover sheet and the Corporate Emerson requirements included in GLOBAL QUALITY MANAGEMENT SYSTEM MANUAL. 0.1 General Redesigning and improving its own Integrated Management System, the Company has evaluated: Its capacity to supply regularly products and services which satisfy Customer requirements and the applicable mandatory references; Risks and opportunities associated to the internal and external context; Customer and stakeholders needs and expectations; Product and service typologies offered; Processes complexity and the interactions of the same ones; Personnel skills; Its dimensions and organizational structure. 0.2 Integrated Management System fundamentals The Company Integrated Management System is based on the following fundamentals: Customer focus; Leadership; People active involvement; Processes approach; Continuous improvement; Decision process based on objective evidences; Relationships management. 0.3 0.3.1 Processes approach General The Company has established a documented and maintained functional SGI to ensure that products supplied are compliant to the explicit and implicit Customer requirements and to the achievement of a company continuous improvement. To properly apply the System, the Company has: arranged an MSGI citing SGI procedures; identified processes necessary to SGI; established consecutions and interactions among the processes and criteria and methods to ensure the operating effectiveness of the same ones through suitable procedures; implemented the SGI applying documented procedures and instructions; defined work instructions; defined the necessary resources; measured, monitored, analyzed the processes and implemented the necessary actions to obtain the results expected and continuous improvement. Furthermore, the Company has defined, described and highlighted its full process in “DR 158 Flow Chart QA” document and employs Value Stream Map methodology, typical of Lean Management, for process management.
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 6 of 43 These documents are constantly updated in order to act from the point of view of processes optimization, continuous improvement, risk management, monitoring of the full process and identification of development and improvement opportunities. 0.3.2 PDCA PDCA methodology, also as known as “Deming Wheel”, is used for SGI management and for particularly strategic processes also in a Kaizen optic (continuous improvement) and it follows the following method: 0.3.3 RISK ASSESSMENT – Risk-Based Thinking Company SGI aims to identify and manage risks and opportunities related to processes, to identify and evaluate risks which could influence on environmental, health and safety conditions and resulting risks and to define the more suitable preventive and protective measures to eliminate and reduce to the minimum the risks. 0.3.4 RISK ASSESSMENT – Quality The Company, in accordance with P-SGQ-03, evaluates, with regard to Quality aspects: All the risks that may prevent Biffi from reaching its objectives (Risk Assessment); All the risks that can lead to a block of production (Business Contingency Plan). The assessed risks are reported on the DR 208-Quality according to the criteria included in the document itself. 0.3.5 RISK ASSESSMENT – Environment The Company chooses to use a methodology similar to GxP (Gravity x Probability) for risk definition and treatment, defining a series of gravity criteria of the probable risks identified, measured with a numeric value, described in DR 208-Environment. The resulting risk value is calculated through the product of the defined criteria gravity, obtaining an R value.
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 7 of 43 If the resulting R value is upper than the value established in DR 208-Environment, then the management defined for the potential risk is activated. Once activated, the new condition is monitored and the criteria definition is updated. For a better understanding, refer to DR 208 Risk Management. 0.3.6 RISK ASSESSMENT – Health & Safety DDL and DS, in association with RSPP, MC collaboration and RLS preventive consultation, have established and drawn up the documents for risks identification and the realization of the necessary prevention, protection and control measures. In the analysis were considered: ordinary and extraordinary activities; activity of the personnel who has access to the workplace (suppliers and visitors included); means and plants on the workplace supplied by BIFFI ITALIA or third parties; product design. The Company ensure that the results of these evaluations and the effects of these verifications are considered when will be defined health and safety goals. The Company supports and keeps updated this information. The methodology used for hazards identification and risks assessment ensures that the evaluation: is defined compared with purpose, nature and timing to guarantee that it is preventive rather than reactive; supplies risks classification and the identification of those ones which have to be eliminated or controlled using measures defined by goals and company management program; is coherent with work experience and control capacity of the current risks; supplies starting points related to the definition of means and plants requirements, training needs identification and/or development of operating controls; provides to the monitoring of necessary actions to ensure the effectiveness and promptness of its realization. All the activities unrolled in the plant and those ones which the Company directly unrolled outside the plant (e.g. transports, Customer service), as well as activities unrolled by third parties in the company plant and which could interfere in company activities (subcontractors) are analyzed to identify the hazards as well as the organizational and operational aspects which could significantly interfere on Health and Safety (in a real or a potential way). This analysis is coordinated by RSPP in collaboration with SPP and all the company structure (managers, supervisors, workers) with MC and the external companies which operates inside the plant or where BIFFI ITALIA personnel go. Only and exclusively regarding Title IV (temporary or moving construction sites) of D.Lgs 81/08, the Company has appointed through a contract a specialized external company to perform the positions of: Works supervisor; Health and Safety Coordinator during works realization; Health and Safety Coordinator during works planning. As above specified, risk assessment is preceded by the consultation from the employer or a delegate of Safety Workers’ Representatives (RLS). Working processes were broken down in elementary phases, sources and dangerous situations are identified and risks evaluated.
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 8 of 43 Occasional activities unrolled inside and outside the plant on which the Company could have an influence are also considered as far as possible. Periodical reports are issued by Works Supervisors and they consent to Biffi Italia S.r.l. to maintain control on these activities. Risk assessment update is annually done during the Review and after possible events or situations which make it necessary (in this case, the Review is had to be done within 30 days from the introduction of the modification as requested by D.Lgs. 81/2008). In particular, the assessment will be updated as a consequence of: legislative, regulatory or by voluntary agreements modification; elements of the unrolled activity and/or product/services modification; audit results and policy modification; design of new products, machineries projects, new/modified plants, changes to production lay-out or used substances/formulations modifications. These projects involve a preventive consultation of RSGSA/RQ, RSPP and RLS. 1. SCOPE AND SGI APPLICABILITY The Company, with the aim to unroll their own activities in the best way and in order to improve the environment in which it works, it decides to adopt an Integrated System Management for Quality, Environment, Health&Safety in compliance with ISO 9001:2015, ISO 14001:2015, ISO 45001:2015 and ISO/IEC 80079-34:2018 reference standards. SGI adopted by the Company establishes management requirements which consent to express the company policy and establish goals which allows to obtain the continuous improvement of the company performances, as well as goals which permit to the organization to identify and manage company risks and improve performances. SGI establishes, documents, effects, maintains and improves continuously the company management system in accordance with International Reference Standards. The following model shows the fundamental processes on which standards ISO 9001:2015, ISO 14001:2015, ISO 45001:2015 and ISO/IEC 80079-34:2018 are based:
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 9 of 43 This Manual and SGI described in it are applicable to the activities of design, production, sales and after sales service for electric, pneumatic, hydraulic, gas-hydraulic and subsea actuators and the related control system respecting contractual and applicable standards requirements. This Manual was realized to provide to stakeholders (internal and external from the Company) a clear and concise image of the company approach to quality, health&safety, environment management describing the principal aspects and the elements necessary to allow the reader to comprehend the way with which the Company has recognized and transferred in operating terms ISO 9001, ISO 14001, ISO 45001:2015 and ISO/IEC 80079-34 standard requirements. This document is one of the cornerstones of the commitment toward Customers and all the stakeholders, together with Integrated Policy. The structure of this Manual is based on the voluntary standards applied. These activities are carried out at Fiorenzuola d’Arda plant in Piacenza province (Strada Biffi,165). 2. NORMATIVE REFERENCES The Company has developed its own integrated management system according to: ISO 9000:2015 model – Quality management system – Basis and vocabulary; ISO 9001:2015 model – Quality management system – Requirements; ISO 9004:2009 model – How to manage an organization for durable success – Quality management approach; ISO 14001:2015 model – Environmental management system – Requirements and User guide; ISO 45001:2015 model – Health and Safety management system – Health and Safety assessment; CEI UNI EN ISO/IEC 80079-34 technical standard – Implementation of quality management system to produce equipment installed in potentially explosive atmospheres. The binding product requirements can be traced in appropriate documents managed by Quality Office. The main EU directives that constitute the references for Biffi actuators are the following: machinery directive, low tension directive, electromagnetic compatibility, PED Directive (2014/68/UE pressure equipment – See P-SGQ-30) e ATEX Directive (2014/34/UE potentially explosive atmospheres), with subsequent amendments and integrations. Binding requirements related to environmental and safety aspects are traceable in specific documents managed at EHS office. 3. TERMS, DEFINITIONS See the HSE Management System procedure PGI 08 regarding “Document Management” for more information for EHS aspects. See the Quality Management System procedure P-SGQ-35 regarding “Documentation Management” for more information for Quality aspects.
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 10 of 43 Here are quoted the functional bodies abbreviations: Abbreviation ACQ AF AGQ AM AMM ASGSA CE COM DDL DS/RD EHS ENG HR LOG MC MKT NC PMG PMO PPP PRD QA RQ RLS RSGSA RSPP SAL SGI SPP Function Sourcing After Sales Quality Management System Employee Atex Manager Administration Environment, Health&Safety Management System Employee Emergency Coordinator Sales Employer Plant Manager / Management Representative Environment, Health&Safety Office Engineering Human Resources Logistics Plant Physician Marketing Non-compliance Product Manager Project Management Production Planning Production Quality Office Quality Management System Manager Workers’ Safety Representative Environment, Health&Safety Management System Manager Prevention and Protection Service Manager Sales Integrated System Management Prevention and Protection Service The following abbreviations are cyclic in the text: SGI MSGI PGI P-SGQ IOA I-SPP I-SGQ SW DR Integrated Management System Integrated Management System Manual Integrated Management Procedure Quality Management System Procedure Environmental Operating Instruction Safety Operating Instruction Quality Management System Instruction Standard Work Recording Document ISO 9001:2015 Terms and definitions used are those defined by standard ISO 9000:2015. ISO 14001:2015 e ISO 45001:2015 Environmental Aspects: element of an activity, product or service of an organization that could interact with the environment.
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 11 of 43 Process: totality of the connected or interacted activities which transform input elements into output elements. Stakeholders: person or organization which could have influence or that could be influenced by a decision or an activity (High Management included). Risk: effect of goals (expected results) uncertainty. Risk could be positive or negative. Acceptable risk: risk level which could be beard by the organization towards its legal obligations and its Health and Safety policies. Performance: measurable results. Monitoring: establishment of a system, process or product status. Involvement: being committed, contribute to the achievement of shared goals. Feedback: viewpoints, comments, expressions of interest to products, services or Claim management processes. Management Review: management formal assessment of the Integrated System status and its adequacy towards the integrated policy and possible new goals deriving from circumstances mutation. Integrated Policy: general goals and directives of an organization related to SGI expressed formally by the High Management. Working environment: context or set of conditions (air, water, soil, natural resources, flora, fauna, human being and their interactions) in which the work is unrolled under organization management. Infrastructure: system of means, equipment and services necessary for organization functioning. Customer: organization or person who receives a product, service or process output. Supplier: organization or person who supplies a product, service or process output (which could be the input of the next process). Monitoring and measuring: set of activities through which the company analyzes and collects the data related to process, services and Integrated Management System application performances, including NCs, corrective and preventive actions, injuries, professional diseases, natural resources use, etc. Non-compliance: failure to meet a requirement. Corrective action: action taken for eliminating the cause of a detected non-compliance or other undesirable situations detected and preventing their repetition. Preventive action: action taken for eliminating the cause of a potential non-compliance or other potential undesirable situations. Serious accident: unwanted event which causes death, health injury, wound, damage or other injuries. Audit: systematic examination to determine if activities and results related to them correspond to the expected regulations and if these standards are respected and suitable for the continuation of organizational policy and goals. Continuous Improvement: process of health and safety management system growth to reach an improvement in health and safety global performances on all the activities, in line with organizational health and safety policy. Danger: source or situation with damage potentiality in terms of wounds or health injury, damage to things, work environment or both. Danger identification: procedure for recognizing the existence of a danger and definition of its characteristics. Accident: event which originates a serious accident or creates its premises. Goals: purposes that an organization intends to reach in a health and safety field. Health and Safety at work: conditions and factors which influence the employees’ wellness, fixedterm workers, subcontractors, visitors and every other person who is at the workplace.
QHSE MANAGEMENT SYSTEM QHSE MANAGEMENT SYSTEM MANUAL MSGI Rev.19 del 07/04/2021 page 12 of 43 Organization: society, operator, company, body or association or a part of them legally known or not, public or private, which have its own functions and administration. Performance: measurable results of the health and safety system management related to the control by the company of health and safety risks based on its policy and goals related to health and safety. Safety: absence of unacceptable risks. ISO/IEC 80079-34 Ex Component: part of Ex equipment or a module (other than an Ex cable gland), marked with symbol “U”, which is not intended to be used alo
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ISO 8402 was published in 1986, with ISO 9000, ISO 9001, ISO 9002, ISO 9003 and ISO 9004 being published in 1987. Further feedback indicated that there was a need to provide users with application guidance for implementing ISO 9001, ISO 9002 and ISO 9003. It was then agreed to re-number ISO 9000 as ISO 9000-1, and to develop ISO 9000-2 as the .
ISO 9000:2000 ISO 9000:2000 refers to the ISO 9000 update released in the year 2000. The ISO 9000:2000 revision had five goals: 1.Meet stakeholder needs 2.Be usable by all sizes of organizations 3.Be usable by all sectors 4.Be simple and clearly understood 5.Connect quality management system to business processes ISO 9000:2000 was again updated .
ISO 9000. ISO 9000:2000 Consists of 3 Areas ISO 9000:2000 Quality Management Systems: fundamentals and vocabulary ISO 9001:2000 Quality Management Systems - Requirements (required for certification) Management responsibility Resource management Product/service realization. Measurement, analysis, improvement ISO 9004-2000 Quality Management .
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ISO 10771-1 ISO 16860 ISO 16889 ISO 18413 ISO 23181 ISO 2941 ISO 2942 ISO 2943 ISO 3724 ISO 3968 ISO 4405 ISO 4406 ISO 4407 ISO 16232-7 DIN 51777 PASSION TO PERFORM PASSION TO PERFORM www.mp ltri.com HEADQUARTERS MP Filtri S.p.A. Via 1 Maggio, 3 20060 Pessano con Bornago (MI) Italy 39 02 957
ISO 45001 Established:-ISO 10006 -Quality in project management-ISO 10007 -Configuration management-ISO 15161 -Food safety (ISO 9000 and HACCP)-ISO 19600 -Compliance management systems-ISO 20000 -IT services-ISO 20121 -Sustainable event management-ISO 20400 -Sustainable purchasing-ISO 22000 -Food safety-ISO 22301 -Business continuity management
ISO 18400-107, ISO 18400-202, ISO 18400-203 and ISO 18400-206, cancels and replaces the first editions of ISO 10381-1:2002, ISO 10381-4:2003, ISO 10381-5:2005, ISO 10381-6:2009 and ISO 10381-8:2006, which have been structurally and technically revised. The new ISO 18400 series is based on a modular structure and cannot be compared to the ISO 10381
