Management System Manual E. NS-EN ISO 9001:2008 Quality Management System NS-EN ISO 14001:2004 Environmental Management System

Transcription

1 Document name Management System Manual Document number E Scope NS-EN ISO 9001:2008 Quality Management System NS-EN ISO 14001:2004 Environmental Management System D Changed in acc. to external and internal audit Steinar Helge Ingelin C Changed in accordance with internal audit Guro Ingelin Rolf B Changed some referance Christian Rolf Torstein A Issued for EPTEC release Christian Ulf Torstein Rev. Issue date Reason for issue Author Review Approved Replacement for: Total number of pages: 12 Additional information (if applicable):

2 Side: 2 av 12 TABLE OF CONTENTS 1. Introduction Scope Normative References Terms and Definitions Management system General Requirements Documentation Control of Documents Control of Records Management responsibility Management Commitment Quality Policy and Customer Focus Environmental Policy and Objectives Quality Objectives and Environmental Targets Responsibility, Authority and Communication Management Review Resource Management Provision of Resources Human Resources Infrastructure and Work Environment Project execution Planning process Identification and Follow-up of Environmental Aspects Operational Control in the EMS Customer-related Processes Design and Development: Planning, Input and Output Engineering and construction Procurement Production and Service Provision Calibration and Control of Tools and Measuring Equipment Monitoring, Measurement, Analysis, Improvement General Customer Satisfaction Monitoring and Measurement of Operations with Significant Environmental Aspects Internal Audit Control of Non-Conformities Analysis of Data Corrective Action and Preventive Action References... 12

3 Side: 3 av INTRODUCTION The EPTEC Group consists of the parent company EPTEC - Energy & Process Technic AS and its daughter company. We are an engineering company with a great many years of experience within energy and process technologies, including rotating equipment, refrigeration and air conditioning. Our main activities have traditionally been in the general industry - industry related to infrastructure and the process industry. I In addition, we have strategic alliances with manufacturers of pumps and compressors for process packages to the oil and gas industry. Our competitive strength consists of high engineer competence, technological skill as well our experience in handling of complex projects. We are using environmental concepts with low energy consumption, low noise execution and refrigerants with low global warming potential. Environmental energy systems will be the focus in future and we are working intensively with modern heat pump technology that can utilize natural energy sources even with low temperatures. EPTEC recognizes its responsibility towards quality and environmental requirements. In order to live up to its promise of high quality and environmentally responsible products EPTEC has appropriately documented and implemented a Management System following the ISO 9001:2008 QMS Standard as well as the ISO 14001:2004 Standard for Environmental Management Systems. Additionally, EPTEC is certified according to Pressure Equipment Directive PED 97/23 EC Module H. This Management System Manual is produced in order to give a comprehensive overview of what specific assurance and control mechanisms have been implemented. It is not only meant to be an information source to our customers, suppliers and employees but also to relevant authorities and other interested stakeholders of ours. Website: eptec@eptec.no

4 Side: 4 av SCOPE The scope of EPTEC s Management System certificate for ISO 9001:2008 QMS and ISO 14001:2004 Environmental Management System covers project engineering and management, sales, service and installation of energy and process systems as well as project- and construction management. Above activities are performed for customers in the Oil & Gas industry, building/construction and general industry. The requirements of ISO 9001:2008 and ISO 14001:2004 are complied with by EPTEC s management system (certificate number 965, Teknologisk Institutt). EPTEC is also certified according to Pressure Equipment Directive PED 97/23 EC (certificate number TK-00042). Additionally are EPTEC as a company and its Service Technicians F-gas Certified. 3. NORMATIVE REFERENCES ISO 9000:2005 makes integral part of this manual and is related to the ISO terminology used. EU Directive 94/9/EC is complied with, e.g. with regard to minimum storage time of documentation and records generated in connection with EPTEC s products and services. Teknologisk Institutt in Oslo/Norway is EPTEC s current certification body for both ISO 9001, ISO and PED 97/23 EC. 4. TERMS AND DEFINITIONS EMS EPTEC HSE MS NC QA QMS Environmental Management System Health, Safety and Environment Management System Non-conformity Quality Assurance Quality Management System

5 Side: 5 av MANAGEMENT SYSTEM 5.1 General Requirements EPTEC generates product and service value by running three main processes (in grey). Each is related to and depending on specific client projects. Management as well as procurement processes support the main processes (in white). Quality and Environment processes (dotted) embrace all of abovementioned processes and are thereby integral part of them. All processes have specific controls imposed on them to secure compliance with customer, statutory and regulatory requirements. Process ownership has been assigned to the respective departments. The interfaces between the main processes are managed by defined hand-over routines. Among other, yearly management reviews and internal audits evaluate process effectiveness and suitability. Output from such review is used to continually improve those processes and keep the quality system updated in accordance with EPTEC s and its customers as well as regulatory and statutory requirements. The scope of EPTEC s Environmental Management System (EMS) includes all activities that relate to the relevant legal requirements and that show significant environmental aspects. Environmental aspects shall hereby always be such ones that can be identified and influenced by EPTEC (ref Prosedyre for identifisering og rangering av miljøaspekter). Quality and Environment processes Owned by: Quality Manager Management processes Main process: Inquiry and Offer Main process: Project Management Main process: Service and Spare Parts Supporting process: Procurement Figure A: EPTEC s business processes The success of company quality policy, and therefore the success of the company, requires on awareness on the part of every individual, in every department at every level of his own contribution to quality and his individual responsibility for it. It is vital that all stakeholders understand that responsibility for quality and environmental aspects is not a specialized function within our company. Respective responsibility rests with each employee and is ensured via introduction and re-training. 5.2 Documentation EPTEC intends to set up and use the manual at hand as a high-level description of its Management System (MS). It shall act as its entry door, provide a quick and comprehensive overview and lead to relevant docu-

6 Side: 6 av 12 mentation and established processes. Every main process as well as the supporting processes have their respective descriptions and rely on dedicated documentation. EPTEC s MS includes procedures, checklists and guidelines. Procedures and checklists are must-follow work instructions, whereas guidelines help keeping a certain process within an allowed frame. Checklists help ensure that product and services comply with their pre-defined quality specification. 5.3 Control of Documents The purpose of document and data control is to ensure that all documentation related to the MS is reviewed and approved by authorized personnel before release. Another purpose is to ensure that only formally released documents are available for use and that obsolete documents are withdrawn from use. However, their availability for history purpose is secured. All released documents are available via our online system called IK-Sentral. MS-related documents are easily identifiable, searchable and downloadable. IK-Sentral also secures adequate access rights and controls document editing and releasing authority. The QA Manager at EPTEC has the overall responsibility for document control and shall be consulted when needed with regards to document numbering, layout, distribution, editing and updating of documents. A respective procedure has been established to control this MS process ( Dokumentstyring). 5.4 Control of Records EPTEC has procedures and systems in place to ensure that records are established and maintained to provide evidence of conformity to customer, regulatory and statutory requirements and of the effective functioning of the Management System. Minimum record storage time is in accordance with EU Directive 94/9/EC (10 years after last day of production of product), unless otherwise stated in contracts /agreements with individual customers. Back-up routines to secure record/document availability and retrieval are in place for EPTEC s IT systems. The following, non-extensive list shows an overview of controlled documentation and records: Documentation of the quality system QA notification, internal and external audit reports and management reviews Product documentation Construction, design and testing documentation regarding customer projects Identification (serial numbers) of products supplied Information on delivered products and services: what, who, when, where, etc. Service and maintenance documentation Documentation showing actions taken towards customers and resp. authorities in case of nonconforming products Documentation of corrective & preventive actions taken 6. MANAGEMENT RESPONSIBILITY 6.1 Management Commitment EPTEC s management is not only dedicated to satisfying customer requirements towards its products and services. It also commits to statutory and regulatory requirements on both quality and environmental product aspects. Specifically regarding potential environmental impact of its products EPTEC is committed to prevent pollution. EPTEC management further commits itself to continuously improving quality, consistency and cost effectiveness of its products and processes. A system for registering and solving detected non-conformances but also for following up improvement suggestions is in place. The manual at hand shows the importance of such MS, internally as well as to external stakeholders.

7 Side: 7 av Quality Policy and Customer Focus Delivering excellent product and service quality to all its customers worldwide is self-evident to EPTEC. Customer requirements and satisfaction are gathered and measured ( Prosedyre for måling av kundetilfredshet). Policy and customer satisfaction make also part of the periodical management review. In more detail the EPTEC s quality policy looks as follows: To supply goods and services meeting customers quality requirements To ensure that equipment is installed and commissioned satisfactorily To deliver effective after-sales service To maintain and develop our knowledge of the market in order to provide the best possible service to customers To safeguard and enhance company reputation for quality We also aim to establish and maintain good relations with partners for manufacture of products and systems included in our scope of supply. This, taken together with our own design, engineering, commissioning, servicing, and coordinating activities, will ensure the highest possible quality content in deliveries from EPTEC. 6.3 Environmental Policy and Objectives EPTEC s policy and objectives to prevent or reduce adverse environmental impact are shaped as follows: - To focus on and maintain continuous awareness of potential pollution risk in all our activities - To follow up current and implement new environmental regulation/legislation fast and targeted - To use processes, practices, techniques and materials to avoid, reduce or control creation and emission of any type of pollutant or waste - To specifically establish and maintain procedures for emergency situations where pollution is an immediate threat or where a pollution incident has taken place already We recognize that successful implementation of above policies demands qualified personnel, the provision of adequate resources and orderly methods of work. This manual and its related procedures and other supporting documents are meant to assist us in our work and will be used as a reference for company policies and procedures as a basis for evaluating and improving current practices to encourage continuity of practice when personnel changes to introduce EPTEC s quality and environmental policies and objectives to new employees 6.4 Quality Objectives and Environmental Targets Delivery time Goal Definition Products 95% in time delivery time +/- 2 days Spare parts 95% in time delivery time +/- 2 days Service - contract 90% in time +/- 2 weeks - emergency 100% in time agreed date Product guarantee cost Guarantee cost less than 2% of total product sales Customer satisfaction objectives 95% satisfied customers (acc. to Prosedyre for måling av kundetilfredshet) Number of credit notes < 3% (of total invoices) HSE objectives no injuries that require medical treatment (H-value shall be 0) less than 3% sick leave

8 Side: 8 av 12 Environmental targets Reduce release of greenhouse gasses by minimizing leakages of traditional refrigerant and by increased use of natural refrigerants with low global warming potential. Targets: at least 20% of delivered equipment (measured of total installed effect in kw) should have natural refrigerants like Ammonia or CO2 report every release of refrigerant 6.5 Responsibility, Authority and Communication EPTEC management has delegated responsibility and authority to a dedicated Quality Manager. The Quality Manager is responsible for establishing and maintaining EPTEC s Management System covering both ISO 9001 and ISO requirements verifying that the requirements of the system are met regarding both quality and environmental aspects identifying risks, issues and recommending solutions, together with all other employees reporting performance of the MS to EPTEC management The Quality Manager also takes steps to have requirements, effectiveness and suitability of the Management System communicated internally with respective focus towards and between all hierarchies in the organization. With regard to the organization s environmental aspects and their significance EPTEC maintains a transparent communication approach. EPTEC s website offers information in both English and Norwegian to all interested external parties. Receipt, documentation and response to external inquiries concerning our EMS are either treated in the project organization or via our management. This depends on the character and source of the communication. 6.6 Management Review EPTEC s management shall review the MS twice a year to ensure its continuing suitability, adequacy and effectiveness ( Ledelsens gjennomgang og internrevisjon). Both quality and environmental aspects shall be part of the review. In addition, status and update according to our PED certification (Pressure Directive Equipment). The review shall comply with the resp. requirements in the ISO 9001 and ISO standards and take into account as a minimum the input and output requirements as stated in those standards. Management Review Meetings are always documented and followed up closely. 7. RESOURCE MANAGEMENT 7.1 Provision of Resources EPTEC depends on the adequate provision of resources to run its business. It therefore continuously evaluates the resource situation (a.o. management meetings and management review) and takes necessary actions when indicated. This includes financial resources which are planned for in yearly budgets. 7.2 Human Resources EPTEC recognizes the importance of competent, qualified, and trained personnel for the success of the company's operations. New employees are to be familiarized with the EPTEC organization, its policies, routines and the quality and environmental system. Continuous internal training for new products is provided. As the need arises employees attend dedicated internal and/or external training courses. ( Personalhåndbok).

9 Side: 9 av 12 Minimum annually, at formal employee talks, current competence level and need for training is discussed, documented and followed up thereafter. 7.3 Infrastructure and Work Environment EPTEC continuously determines, provides and maintains the infrastructure needed to achieve conformity to product and environmental requirements (e.g. work space, utilities, process equipment and supporting services like IT). EPTEC has further established and implemented Health, Safety & Environment (HSE) procedures according to local laws and regulations ( HMS-manual for ). A dedicated HSE responsible is in place. 8. PROJECT EXECUTION 8.1 Planning process Quality objectives and requirements for our products have been clearly determined. Processes serving this purpose have been put in place, e.g. product and construction/design documentation which is used as standard in all projects. Necessary records have been determined and are constantly improved. Requirements regarding verification, monitoring, inspection, and testing to ensure desired product quality and acceptance of it have been defined. 8.2 Identification and Follow-up of Environmental Aspects EPTEC has implemented and maintains procedures to adequately identify significant environmental aspects of its activities and products. At the same time it is regularly evaluated and determined what effects those aspects have or can have on the environment (see Prosedyre for risikovurdering i prosjekt and Ledelsens gjennomgang og internrevisjon). Output from such analyzes is further used to establish, implement and maintain emergency preparedness and response. 8.3 Operational Control in the EMS With respect to identified environmental aspects and EPTEC s environmental policy, objectives and targets, control in day-to-day operations is essential. Respective processes have been identified and are planned for in written by taking into account above environmental aspects. Where relevant, this is also communicated to our suppliers and contractors. 8.4 Customer-related Processes Winning and constantly satisfying our customers, starts with determining their requirements. Client communication processes (clarifications, offers, feedback, complaints, etc.) are cared for in the respective processowning departments ( Prosedyre for måling av kundetilfredshet). Further, customer requirements and contracts go through standard review processes. This ensures that deviations are kept at a minimum, both before and after contract commitment (ref Prosedyre for prosjektgjennomføring). Respective records are kept for each project. EPTEC further secures adequate knowledge of statutory and regulatory requirements by closely following up the respective rules, laws and guidelines ( Myndighetskrav). This counts for requirements both in the area of product quality as well as environmental aspects.

10 Side: 10 av Design and Development: Planning, Input and Output While EPTEC does not have processes linked to research or development of its products it still performs activities that refer to design and construction of component systems. Such systems are assembled from various third-party components. Establishing a project organisation ensures appropriate control of interfaces and effective communication. Further, during progress on the project, suitable information is generated and collected to enable verification of the product against its initial specification. Such information also includes data required by the procurement and service functions to plan and perform their related activities. 8.6 Engineering and construction For assembled refrigeration systems applies EN 378 1/2/3/4 and Pressure Equipment Directive PED 97/23 EC. Assembled refrigeration systems shall be categorized according to the requirements of Pressure Equipment Directive and implemented as described in our procedure ( Prosedyre for PED). Potential design changes are handled and agreed on via variation order requests (ref Prosedyre for prosjektgjennomføring). Validation of a finished project is normally done with factory/site acceptance tests. Respective commissioning and test procedures have been established and are to be followed strictly by EPTEC personnel. 8.7 Procurement The capabilities of our suppliers make an obvious and important contribution to the products and services supplied by EPTEC. It is therefore essential that we select suppliers who are able to meet specified requirements ( Prosedyre for leverandørgodkjennelse). Purchase requirements are determined and communicated very clearly and unambiguously ( Prosedyre for innkjøp og lagerføring). A yearly approval routine for key suppliers supports EPTEC in securing component quality (checklist in Prosedyre for leverandørgodkjennelse). Additionally, purchased goods and accompanying documentation undergo incoming inspection and verification activities before storage or use in a client project ( Prosedyre for inngangskontroll, vareinspeksjon og varemottak). 8.8 Production and Service Provision EPTEC shall provide products and services under controlled conditions. This includes provision of adequate documentation, including relevant procedures. Deficiencies in product or service provision should be avoided or detected before delivery. Therefore, procedures and routines are provided for in such a way that planned results are achieved acc. to specification. In case of non-conformity after delivery, respective measures have been established and implemented ( Prosedyre for avvikshåndtering). 8.9 Calibration and Control of Tools and Measuring Equipment Appropriate testing and calibration of tools and measurement equipment secure correct product acceptance. Equipment shall therefore be calibrated in accordance with applicable statutory regulations and company requirements. Respective measurement uncertainties shall be known and be complying with requirements.

11 Side: 11 av MONITORING, MEASUREMENT, ANALYSIS, IMPROVEMENT 9.1 General EPTEC is committed to continually improve its product and services quality. Respective processes are in place to ensure continued conformity with customer, statutory and regulatory requirements. The effectiveness and suitability of the MS is regularly under scrutiny in order to continuously improve it. Management review and internal audits are examples for this. 9.2 Customer Satisfaction Project-based customer satisfaction surveys are in use to keep track of our client satisfaction level. The procedure ( Prosedyre for måling av kundetilfredshet) shows how the measurement shall to be executed and how the responsibilities are distributed. Analysis of output data from the survey are done continuously as well as in the annual management review. The QA Manager together with the project engineers is responsible for initiating, monitoring and communicating necessary improvements. 9.3 Monitoring and Measurement of Operations with Significant Environmental Aspects EPTEC monitors and measures the key characteristics of its operations that can have a significant environmental impact. This is in most cases concerning the performance of our products and less our production operations themselves. Relevant controls are established in the final product testing before delivery. 9.4 Internal Audit EPTEC performs annual internal audits to determine whether the MS complies with the resp. standards, internal requirements and the planned way of product and service realization. The focus for internal audits is normally derived from changes in product, MS and/or other areas which had shown critical issues. The evaluation of compliance with applicable legal requirements makes standard part of such audit. ( Ledelsens gjennomgang og internrevisjon). Internal audits can be carried out by EPTEC internal personnel who can act independently and objectively towards the audited areas. The auditor shall have competence for performing audits. Respective audit reports shall be distributed to EPTEC s management. The QA Manager takes responsibility for having nonconformances analyzed and corrective and/or preventive actions proposed. 9.5 Control of Non-Conformities EPTEC has established a system for detecting, registering and following up non-conformances (NC). Registration and follow-up of both NC s and improvement proposals is handled in an online system called IK- Sentral. A respective procedure is in place and describes process flow and responsibilities ( Prosedyre for avvikshåndtering). The QA Manager is responsible for initiating follow-up with internal and external customers as well as authorities, where necessary. EPTEC s NC procedure secures among other that all detected non-conformances are reported and documented a risk analysis is performed in case the NC is estimated critical effective corrective/preventive actions are taken to eliminate the NC and its root cause non-conforming products are separated from others if detected before delivery corrective action (incl. risk analysis if necessary) is taken for non-conformities detected after delivery use, release or acceptance of non-conforming product is only authorized under concession of the notified body and/or the customer Improvement proposals are reviewed and put into action where reasonable

12 Side: 12 av Analysis of Data EPTEC has determined what data needs to be collected and analyzed for the QMS to be evaluated on effectiveness and suitability. Such analysis shall at a minimum cover the following: Conformity of product/services/processes to their pre-defined specifications Characteristics and trends of processes and products, incl. opportunities for preventive action Customer satisfaction Supplier quality It is the QA Manager s responsibility to periodically perform such analysis of the trends derived from NC data. Serious negative trends shall be brought up immediately with the responsible personnel and EPTEC management. 9.7 Corrective Action and Preventive Action Corrective and preventive actions are handled acc. to a defined ( Prosedyre for avvikshåndtering). The purpose of this routine is to ensure that the causes of non-conformances are identified and that reoccurrence of the same non-conformances is avoided (root-cause elimination). Procedures for corrective actions include: Review of non-conformances and cause determination Need for preventive action in order to avoid recurrence Record-keeping Review of effectiveness of the corrective actions taken Procedures for preventive actions include: Determination of potential non-conformances and their causes Evaluation of need for action to prevent non-conformity occurrence Determination and implementation of action Record-keeping Review of effectiveness of preventive actions taken The QA Manager is in charge of maintaining the processes of non-conformities, corrective and preventive actions. 10. REFERENCES Personalhåndbok HMS-manual Prosedyre for identifikasjon av miljøaspekter Prosedyre for avvikshåndtering Myndighetskrav Dokumentstyring Ledelsens gjennomgang og internrevisjon Prosedyre for måling av kundetilfredshet Prosedyre for innkjøp og lagerføring Prosedyre for inngangskontroll, vareinspeksjon og varemottak Prosedyre for leverandørgodkjennelse Prosedyre for prosjektgjennomføring Prosedyre for risikovurdering og risikostyring i prosjekt Prosedyre for PED