Forth Engineering (Cumbria) Limited QUALITY MANUAL. Quality Manual Issue 4 Updated April Authorised by: Managing Director.

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1 Quality Manual Issue 4 Forth Engineering (Cumbria) Limited QUALITY MANUAL Copy Number: 1 The information contained in this Manual is the property of Forth Engineering (Cumbria) Limited and must not be copied or used in any way without its previous consent in writing. The Company shall not be liable for any loss or damage whatsoever resulting from the use of this information and no warranty is given as to its accuracy. Authorised by: Managing Director Date:

2 Contents Page 1 Introduction 3 2 Forth Engineering Quality Policy 4 3 Forth Engineering System Structure and Scope 5 4 Forth Engineering Organisation 6 5 Forth Engineering Processes 7 6 Work Environment and Infrastructure 7 7 Customer Communication and Orders 8 8 Procurement 8 9 Operations Process Routes 9 10 Calibration Controlling and Correcting Non-conformity and Responding 11 to Customer Complaints 12 Monitoring, Reviewing, Improving and Planning 11 Complying with ISO Document History 12 Authorised: Page 2 of 13

3 1. Introduction In November 2000, Forth Engineering (Cumbria) Ltd began with a simple idea, supplying hoses made to the customer's specifications, with supply only or fitting onsite. The idea soon developed into products ranging from valves to high pressure connectors from a single source and to provide the technical help needed to solve customers' interface problems. The motto: "If you don't see it, ask for it." In 2003 the business relocated to a fully equipped operations centre at Risehow Hydraulics Centre on the outskirts of Maryport, Cumbria. The premises, which have increased total capacity by over 100 per cent, house a dedicated warehousing and despatch area, customer demonstration and training facilities, administrative offices and an advanced technical centre, all catering for the highly skilled staff involved. Further premises upgrades in 2009 provide a fully operational Nuclear Research and Development Centre, allowing real-time safe trials and testing. Authorised: Page 3 of 13

4 2. Forth Engineering (Cumbria) Limited Quality Policy It is the policy of FORTH Engineering Cumbria Limited to provide complete customer satisfaction, and to supply products and systems that are fit for their intended purpose and conform in all respects to customers needs. In consequence the company operates a quality management system designed to satisfy the requirements of ISO 9001:2008. This objective is achieved through defined processes that are regularly monitored and reviewed to promote continual improvement. Every employee plays an important part in the satisfactory operation of the company's quality management system. Its success depends upon the everyday actions of all employees, and the Company ensures that they have the resources of training and equipment they need to achieve their objectives. The management is committed to: providing excellent products and first-class services for our customers. initiating and maintaining mutually beneficial long-term partnerships with both our suppliers and our customers. providing resources throughout the company to achieve a culture of continuous improvement with objectives of assuring customer satisfaction and driving towards the goal of defect-free performance in everything that we do. The Managing Director and all management at FORTH Engineering have endorsed the Quality Policy as an effective statement, commensurate with the Company s purpose. Each Manager ensures that personnel at all levels are fully knowledgeable of the Company Quality Policy. The processes contained within the FORTH Engineering Quality Management System provide for regular review of quality policy as well as setting objectives for performance and continuing suitability. Authorised: Page 4 of 13

5 Forth Engineering System Structure and Scope 3.1. In order to assure ourselves and our customers that our products and services consistently meet customer requirements we operate a quality management system in accordance with ISO9001. This Quality Manual sets out the policies of Forth Engineering Cumbria Limited. Further detail is given in the procedures and other documents referenced in the text. We generate records in the performance of our operations In addition, Forth Engineering has a Health and Safety Policy supported by Risk Assessments, an Environmental Policy supported by other environmental documentation and an Equal Opportunities Policy Forth Engineering documents are managed under PD010 Document Control Procedure and our records are managed using PD011 Records Control Procedure. These include customer supplied data, information or intellectual property The scope of our Quality Management System covers sales of proprietary industrial equipment, components for fluid power systems, assembly and supply of fluid power hoses, manufacture of bespoke fluid power systems, repairs and servicing of fluid power components and systems, providing proof of concept for nuclear innovations, research and development, engineering fabrication and design Forth Engineering (Cumbria) Limited plays a significant role in the development of bespoke hydraulic systems to meet evolving customer needs. Usually this is done by providing advice to the design houses nominated by our customers. Occasionally we provide the design ourselves, in which case designs are reviewed, verified and validated under PD015 Design Procedure. Authorised: Page 5 of 13

6 3. Forth Engineering Organisation The company structure and special responsibilities are shown in the diagram below. Company Secretary Quality Manager, Training Managing Director Health & Safety Environmental Protection Financial Controller Office Manager Logistics Controller Stock Controller Mechanical Supervisor Engineering Manager Business Development Manager Senior Administrator Trainee Administrator Engineers Apprentice Engineer Trainee Electrical Engineer 4.1. Personnel are assigned responsibilities within Job Descriptions on the basis of suitable qualification, experience, training and skills. Their competence is assessed and verified by Management and logged on a SQEP matrix New staff are inducted and training needs are assessed and provided for through the staff review scheme described in PD009 Training Staff Procedure before deployment on new duties. This includes induction to customer sites, where this is a requirement Internal communication is achieved through line management, departmental and occasional companywide meetings and meeting minutes. Authorised: Page 6 of 13

7 Internal Auditing, Monitoring, Review and Improvement Job Sheet Document and Records Control Job Pack 5. Forth Engineering Processes The Quality Management System is based on a commitment by the Directors to a process of continual improvement in processes, products and services, as shown below. Customer Orders Training Procurement Calibration Operations Design Goods In Out Consultancy Parts & Equipment Sales Hose Assemblies & Surveys Work environment and infrastructure Bespoke Systems Repairs Projects Facility Use Control of Non- Conformities 6. Work Environment and Infrastructure Support systems such as computer systems, telecommunications and utilities are managed by the Directors and maintained so that they contribute to reliable and consistent product and service delivery. Premises, equipment and the company vehicles are maintained in good order and safely to comply with relevant legislation and this is described in the Health and Safety Policy. Resource needs are identified through the planning and review process. Authorised: Page 7 of 13

8 7. Customer Communication and Orders 7.1. Our Managers and sales team hold regular review meetings with key customers, and staff meet with other customers to determine their needs and expectations Feedback from these customer meetings is used to ensure that these requirements are taken into account in the assembly and delivery of products and services, with the aim of achieving total customer satisfaction. For project work, a quality plan is devised to ensure all criteria can be met This includes compliance with regulatory and statutory requirements where applicable Forth Engineering reviews the requirements of each new customer order before commitment is made (e.g. submission of any tender, or acceptance of a contract or order), to check that product requirements are defined and differences from tender, quotation or previous order for the same or similar product are resolved and that any applicable quality plan is approved by the customer Changes to orders or specifications are also reviewed. Proposed changes to Forth procurement arrangements for project work are submitted to the customer for prior approval Records of reviews are maintained Reviews and quality planning are described in the appropriate procedures (PDs), particularly PD016 Consultancy, PD017 Bespoke Systems and PD018 Projects. 8. Procurement 8.1. We evaluate and select suppliers and subcontractors on their ability to supply products and services that meet the company s requirements. Selection and evaluation criteria are set based on the quality impact of the products or services provided using a Supplier Questionnaire All regular suppliers and subcontractors are listed on the approved suppliers list on the computer system. One-off or irregular purchases are made, subject to goods inwards inspection or service monitoring Management continually assess suppliers and subcontractors based on their performance. Where suppliers performance is unsatisfactory, a Non-conformity Report is raised and their performance is reviewed at a monthly Management Meeting. When a decision is taken not to procure from a supplier, this is marked as * Authorised: Page 8 of 13

9 DO NOT USE* on the suppliers list Procurement is controlled using our Purchasing Goods and DGS Procedures, to ensure purchases are fully specified and authorised All quality significant purchased products and services are monitored on receipt to ensure that they conform to the specified purchase requirements before acceptance and release to production. The extent of inspection to be applied in each case depends on the degree of control exercised by the supplier, and the documentation supplied. This is described in the Goods In Out Procedure. Customer supplied goods are similarly inspected, and identified. 9. Operations 9.1. Workshop and site operations are carried out under controlled conditions, which include: Documentation which defines the requirements Operating Procedures (PD and PD ) Suitable materials, tools, equipment and measuring devices Competent personnel 9.2. Systems and components (including customer free issue goods) are identified at all stages, from receipt, through storage and processing, to despatch. The status of any system or order, with respect to production stage, inspection and tests, is shown at all stages on a Job Pack, Job Sheet or Lifetime Quality Record Individual traceability to batch or date of manufacture is maintained where specified All finished product and systems are subject to independent final inspection (i.e. by an appropriately qualified person who has not been involved in the work) to ensure conformity with requirements, and, where necessary, to ensure that all previous inspections have been carried-out, and that the required procedures have been followed. When final inspection is satisfactory, goods are released for despatch Where the output from processes cannot be verified by subsequent monitoring or measurement, these processes are subject to regular validation and continuous monitoring to ensure that the processes are carried out correctly and achieve the planned results. Suitable suppliers provide coded fabrication services These arrangements include: defined criteria for review and approval of these processes approval of equipment and qualification of personnel use of specific methods and procedures Authorised: Page 9 of 13

10 maintaining records revalidation 9.7. Currently this applies only to assembly of fluid power hoses and project work as specified To ensure that product and components are preserved from damage and deterioration and conform to specified requirements components, work in process (including customer free issue goods) and finished products are stored in designated areas within a dry, ambient temperature store in accordance with Suppliers recommendations. The condition of product in storage is subject to regular monitoring and inspection. Non-conforming product is identified and segregated. However, under these controlled conditions, components held in stock do not deteriorate with age and therefore date coding and records are not necessary Deliveries are scheduled to ensure that customers requirements are met and packaging and transport methods are arranged to ensure quality of product is maintained. 10. Calibration The tools, monitoring and measuring equipment used in the workshops and on customers sites, to ensure that products and systems meet with specification are subject to regular inspection to ensure capability to requirements and are kept as follows: Equipment Cupboard All items logged in Equipment Record Book when taken out (date and user) and when replaced. Any faulty equipment is identified with a Quarantine Tag, recorded in the Equipment Record Book and reported to the Quality Operations Manager. Each service van has a designated stock Certain identified measuring equipment (verniers, tapes and non-calibrated pressure gauges) is used for reference purposes only and is not subject to calibration Specific equipment is subject to calibration and the Quality Operations Manager ensures that it is: calibrated and verified at regular intervals, or prior to use, against measurement standards traceable to international or national measurement standards with records maintained; where no such standards exist, the basis used for calibration or verification is recorded Authorised: Page 10 of 13

11 adjusted or re-adjusted as necessary identified with the calibration status, safeguarded from adjustments that would invalidate the measurement result handled, maintained and stored to prevent damage or deterioration When equipment is found not to conform to calibration requirements, the validity of previous measuring results is assessed and recorded, and appropriate action taken in respect of any product actually or potentially affected. 11. Controlling and Correcting Non-conformity and Responding to Customer Complaints We concentrate on ensuring that products and service are delivered right first time. However, Procedure PD013, Controlling Non-conformity describes Forth Engineering arrangements to ensure that should non-conforming material, product or process occur the potential impact on the customer is minimised by preventing its use or release, remedying any current impact, investigating the cause and taking corrective action to prevent a recurrence and learn from experience. This procedure also details communication about and resolution of customer complaints. 12. Monitoring, Review, Improvement and Planning Internally, we review the effectiveness and efficiency of our quality management system through internal audit, regular monitoring of process performance, product/service conformity and customer satisfaction, and the data are fed into the review process The Managing Director and other members of the management team are committed to the maintenance, development and improvement of the quality management system and the continual improvement of quality throughout the company. To this end we ensure that the Quality Management System is updated to take account of changing customer requirements, changing requirements of international standards such as ISO 9001 and ISO14001, technological and other advances and our own experience Minor improvements are made whenever the opportunity arises and is viable, but Management Review provides a means of identifying larger scale or longer term improvements, prevention of potential problems, preparation for new processes or requirements for resources, setting objectives and feeding these into the business planning process. Authorised: Page 11 of 13

12 12.4. These arrangements are detailed in PD012 Internal Audits and PD014 Monitoring, Review and Improvement. Authorised: Page 12 of 13

13 Complying with ISO 9001 ISO9001 requirement Quality Management System section 4.1 Quality Management System Quality Manual 4.2.1, 5.3 Quality Policy Manual Section , 5.4 Quality Objectives Manual Section Quality Manual Quality Manual Control of Documents Manual Section 3, PD010 Document Control Control of Records Manual Section 3, PD011 Records Control 5.1, 5.4 Management Commitment Manual Section 2 & Customer Focus Manual Section Responsibilities & authorities Manual Section 4 and all System 5.6 Management Review Manual Section 12, PD014 Monitoring, Review and Improvement 6.1, 6.3, 6.4 Provision of Resources, Infrastructure & Work Environment Manual Section 6 & 9 Health & Safety Policy 6.2 Human Resources Manual Section 4, PD009 Training Staff 7.1 Planning of Product Realization Manual Sections 7, 9 & 12, PD014 Monitoring, Review and Improvement 7.2 Customer Related Processes Manual Section 7, PD and PD Design & Development Manual Section 3, PD015 Design 7.4 Purchasing Manual Section 8, PD003, PD006, PD Product & Service Provision Manual Section 9, PD and PD Control of measuring & Manual Section 10 monitoring devices 8.1 Measurement, Analysis & Improvement Manual Sections 9 & 12, PD014 Monitoring, Review and Improvement 8.2 Monitoring & Measurement Manual Section 9 & 12, PD014 Monitoring, Review and Improvement Internal Audit Manual Section 12, PD012 Internal Audits 8.3 Control of Non-conforming Manual Section 11, PD013 Control of Non-conformity Product 8.4 Analysis of Data Manual Section 12, PD014 Monitoring, Review and Improvement 8.5 Improvement Manual Sections 11 & 12, PD014 Monitoring, Review and Improvement, PD013 Control of Non-conformity Issue No. 1 2,3,4 3 Sections All First Changed issue QM1,QM3, QM5, QM7 for ISO9001: 2008 Document History All merged - to simplify. Scope change Conversion to PDs Authorised: Page 13 of 13