Connecticut Valve & Fitting Co.

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1 Connecticut Valve & Fitting Co. 120 Long Hill Cross Road Shelton, CT Phone Fax Revision 03 Date of Revision 12/14/2010 Quality Manual Approved by: Greg Hines (President) Amy Rogers (Quality Manager) Date: 12/14/ /14/2010 Signature: 1

2 Table of Contents Section Page Section Page Introduction 3 Product Realization 10 Scope 3 Contract Review Order Entry Purchasing Quality Policy 4 Outsourcing Custom Solutions Planning & Assembly Basis for this manual 4 Custom Solutions Factory Approval Requirements Process Model 4 Identification & Traceability Receiving & Shipping Quality System 5 Packaging, Handling & Storage Rentals 10CFR21 Reporting Process Approach 5 Measurement, Analysis & 15 Improvement Quality System Documentation 6 Customer Satisfaction 16 Document Control 6 Internal Auditing 16 Record Control 6 Continuous 17 Improvement Management Responsibility 7 Corrective Action Preventative Action Quality & Business 7 Non-Conforming 17 Planning Product Quality Objectives 7 Product Recall 18 Communication 7 Measurement & 18 Analysis Management Review 8 Document History 19 Resource Management 9 Training & 9 Qualification Equipment 10 Maintenance Calibration

3 Introduction To our valued customers: Connecticut Valve & Fitting Co. is proud to be an exclusive sales and service center providing Swagelok products and solutions. Your unique business challenges and product applications have provided an opportunity for our business to grow over the years. It seems that every year you are challenged to grow your own businesses with fewer resources and less technical support. You continue to find ways to meet the demands of a changing marketplace and it is our goal to support your efforts. We are committed to continuing to innovate and adapt our business to meet your requirements. We know that this will require the highest commitment to quality and continuous improvement. All of our associates are dedicated to improving every day. To the best of our knowledge and belief, this is in accordance with the Swagelok Quality System, 10CFR50 Appendix B and ISO 9001:2008. We are committed to zero customer disappointments and will continuously monitor and measure the effectiveness of the quality systems in place. Thank you for your continued support as together we take on the challenges of today and plan for the challenges of the future. Sincerely, Greg Hines President Scope Scope of certification for ISO 9001:2008 The distribution and assembly of fluid system components. The scope of the quality management system at Connecticut Valve & Fitting Co. includes all activities, from integrated services and postponement to activities related to selling and servicing Swagelok products. Changes that may affect quality control or approval status are communicated to Swagelok. These may include, but are not limited to quality system scope/quality manual changes quality system certification status sales and service center ownership sales and service center quality management representative 3

4 Relocation and/or addition of any functions defined in this policy document. (example: Adding a branch location or beginning integrated service activity in a branch location) Only personnel qualified through appropriate Swagelok certification programs perform activities related to custom solutions. Where certification programs do not exist, requests are processed according to the sourcing and assembly process and we will follow acceptable industry standard guidelines for technical competencies. Proficiencies will apply. Under no circumstances will work requiring a Swagelok certification program be performed by someone without those credentials. Exclusion: Connecticut Valve and Fitting does not perform Design and Development as defined in the requirements of ISO 9001:2008 Section 7.3. Design and development of Swagelok products is performed by Swagelok Company. Custom solutions work and fabrication performed by Connecticut Valve and Fitting is according to customer provided requirements, in compliance with the Swagelok Quality System (SQS) policies and as defined in this manual. Quality Policy Connecticut Valve & Fitting Co. is SQS certified, with an unrelenting commitment to seeking and incorporating customer and associate feedback to continuously improve our performance. We are committed to: quickly and efficiently meeting customer requirements on time delivery of safe, reliable, defect-free fluid system solutions providing support and service that exceeds customer expectations and; continuously improving the effectiveness of our quality system We develop organizational excellence and quality awareness through innovative process improvements, training, measurements and development of customer and employee satisfaction programs. Basis for this manual To ensure an effective quality system is created, documented and managed to meet the requirements of the Swagelok Quality System (SQS) for Authorized Sales & Service Centers, ISO 9001:2008 and 10CFR50 Appendix B. As an authorized organization performing integrated services and postponement-related activities, meeting or exceeding the SQS objectives, policies and requirements is vital to ensure quality products, processes and systems. This manual describes how we meet each of these requirements. Process Model Connecticut Valve & Fitting Co. promotes the use of a process approach to describe the overall design & interaction of business processes. This approach will help ensure the effectiveness of the overall system to meet customer expectations for execution & continuous improvement. 4

5 Quality System Requirements Connecticut Valve & Fitting Co. has established documented, implemented and maintains a quality system and continuously improves its effectiveness. The quality system refers to the network of quality and business processes needed to regulate, control and improve the quality of products and services. Process Approach Connecticut Valve & Fitting Co. has adopted a process methodology to define and manage business and quality activities of our quality system. The process approach is built on the understanding that a desired result is achieved more efficiently when activities and related resources are planned and managed as a process. The process approach is a management strategy that means understanding and managing the processes in the organization, their interactions with each other and the inputs and outputs that glue them together. Following established processes will provide better overall results than the results of individuals putting forth their best individual efforts. Customer-related, support, management and improvement processes needed to meet the requirements of the quality system have been identified, as well as a process owner for each. Connecticut Valve & Fitting Co. defines the sequences and interactions of the processes, as well as key interfaces with Swagelok processes as described in the process model below: 5

6 Quality System Documentation This quality manual describes our Quality processes and appropriate business process documentation. The manual is a communication tool to describe the process of planning, managing, and improving quality, and will be used with customer, corporate and internal audiences. Document Control Documents required by Swagelok, customers, regulators or other sources are controlled, and the method of control is defined and documented in procedure QS2. Document control ensures authority, accuracy, & the currency on which Connecticut Valve & Fitting Co. acts. Document control refers to the system of collecting, reviewing, revising, approving, accessing, filing, indexing, maintaining and disposing of electronic and hard-copy documents. Documents which are essential in ensuring the consistent operation of Connecticut Valve & Fitting Co. are controlled and identified with a document number. Other documents need not be controlled but are nonetheless identified with a document number and are classified as Uncontrolled. Relevant documents shall be appropriate to their intended purpose, available at points of use, up-to-date and legible. If a process is changed, the documented procedures must also be revised according to defined practices. A history of process changes also should be maintained to provide evidence of the development and improvement of modifications. Record Control Records required as a part of our business system will be maintained in a manner that allows for prompt retrieval. The method of control is documented in procedure QS1. A list of records under record control jurisdiction is maintained in the document Records Matrix Template.doc. Quality records are evidence that the quality system has been followed and activity has been performed. Examples of records include but are not limited to purchase orders, sales records, contracts, internal audits, and test data. 6

7 Management Responsibility Effective leadership greatly enhances the possibility that initiative, dedication and innovation will flourish throughout an organization; the accompanying positive impact on productivity and continual improvement is obvious. The president of our organization shall establish clear direction and purpose for quality, and create an environment that encourages associates to achieve organizational objectives. The president must be responsible for keeping the focus on customers and meeting or exceeding customer expectations in systematic and measurable ways. Quality and Business Planning During our annual business planning, the impact of changes in our business is assessed to ensure the integrity of the quality system, and define appropriate action to ensure its continued effectiveness. Furthermore, the process serves to assure that our business plan and quality systems are in alignment with Swagelok s quality objectives. Quality Objectives Quality objectives are established annually during our normal operational planning activities. Objectives are communicated at each relevant function and level within the organization. Communication Work responsibilities and decision-making authority are defined and communicated within the organization. These responsibilities are depicted in the following organization 7

8 chart: The Quality Manager is the quality management representative. The quality management representative has the responsibility and authority to: assure that quality system processes are established, implemented and maintained; report on the performance of the system and any needs for improvement; promote awareness of customer requirements to all associates; and act as a liaison for Connecticut Valve & Fitting Co. for issues of quality. Management Review The quality system is reviewed regularly to determine continued suitability for our organization, market, scope of activities and work, as well as for performance and effectiveness. Through this Management Review process we ensure that customer satisfaction is met, customer requirements are completely comprehended, planning activities include objectives at each relevant point within the organization, internal communications are established, and information within the system is used to facilitate progress. The following inputs, at a minimum, are included in the review: feedback from Swagelok, results of audits, customer feedback, including complaints and product returns, process performance and product conformity, 8

9 status of preventive and corrective actions, follow-up actions from previous management reviews, changes that could affect the quality system, and recommendations for improvement. The results of the review include decisions and actions related to: improvement of the effectiveness of operations and processes, including the quality system, improvement of product related to customer requirements, and resources needs. Resource Management Connecticut Valve & Fitting Co. plans for, identifies, assigns and manages resources needed to maintain and continuously improve the effectiveness of business and quality system, and enhance customer satisfaction. Training and Qualification Training and qualification provides our employees with the tools they need to successfully and efficiently fulfill their job requirements. The thorough education of our trained and qualified employees reflects directly to our customers through the high level customer service we provide and the quality products we distribute and produce. Associate competence and experience, as it relates to the tasks at hand, is documented in RM9. Training needs and qualification requirements, such as Swagelok certification programs or legal, regulatory, customer or market/industry instruction, are managed throughout the Training and Qualification process. 9

10 Equipment Maintenance We have established, documented and continue to manage the process for maintaining equipment in order to deliver the highest quality products and service. In this process, we ensure that our equipment is functioning properly and preventing equipment failure and malfunction. The process is documented in RM10. Calibration The process to control the monitoring and measuring of instruments used to provide evidence of conformity to product and process requirements is documented in the Calibration process RM14. This process is important to effectively manage because it will ensure that all gages and other methods to verify product provide accurate measurements. Records of calibrations will be maintained and includes: the monitoring and measuring device number the date the calibration was performed identification of standard(s) used for calibrating identification of personnel/company performing the calibration disposition of the monitoring and measuring device location of the monitoring and measuring device Product Realization Connecticut Valve & Fitting Co. has developed processes that identify, plan for, control and fulfill customer requirements on all products and services. 10

11 Product realization is the term used to describe the work that we go through to develop, manufacture, and deliver finished goods or services. An effective quality system provides a comprehensive approach to getting from product requirements to finished product. Our approach is a quality plan that includes: product requirements and quality objectives; processes, documents, and resources needed for product realization; required verification, monitoring, inspection, and test activities, and a list of records to be maintained. Contract Review We provide our customers with accurate quotations by gathering, reviewing and confirming the requirements of each quote/order/contract prior to acceptance and effectively communicate with customers in regards to product information, contracts and order handling. This process is titled Contract Review Process and can be found in PR6. Our Quote process used for creating and providing the customer with a document of proposed product specifications and conditions of sale can be found in PR7. Quote records will minimally include: customer name date of quote Swagelok product part numbers and quantity customer part number(s) and drawings, as appropriate customer and/or regulatory specifications, as appropriate packaging and freight proposals delivery terms other terms and conditions pricing Order Entry We obtain and accurately process information from customer purchase orders. The result of this process is a completed customer order in our business systems that is correctly shipped and invoiced to the customer in a timely manner. Our process for Order Entry can be found in PR3. Order Entry records will minimally include: 11

12 customer name date of order name of customer service associate who processed the order Swagelok part numbers and quantity purchase order number or credit card information customer or regulatory specifications, as appropriate signed customer drawings, as appropriate packaging and freight specifications delivery method special terms and conditions pricing Purchasing We review and purchase any Swagelok items needed to satisfy customer orders and replenish our inventory. This process ensures precise order fulfillment through Swagelok and the timely delivery of customer orders. By replenishing our inventory through our categorical purchasing process, we are better able to fulfill and ship many customer orders from stock. The Purchasing process is defined in document PR11 and PR42. Outsourcing We verify, quote, and order appropriate materials to be purchased through suppliers other than Swagelok. This process is defined in PR42. We track and record outside supplier performance regarding issues such as on-time delivery, non-conformance, and other measures. This careful analysis and record keeping ensures that we only use exceptional outside vendors for completion of customer orders and helps us maintain the integrity of the Swagelok brand. Custom Solutions Planning & Assembly We plan production and service processes and provide an environment where work can proceed in an orderly fashion as defined in the process PR17. We ensure that the product is manufactured/ assembled/purchased to the latest revision of all documents. 12

13 Custom solutions planning and production process refers to the overall system for carrying out production and service based upon the related requirements from the customer. This ensures the manufacturing and assembly processes meet product requirements and align with the customer requirements. Custom solutions planning records may include but are not limited to: drawings, bills of material, customer approval signatures (as appropriate), and the integrated service sales form. We assemble all custom solutions products through consistent and documented procedures, ensuring that customer requirements are fulfilled in an orderly and accurate manner. Custom solutions assembly records may include but are not limited to: bills of material, drawings, product requirements checklists, welding verification book, and Swagelok certifications. Custom Solutions Factory Approval Requirements Approval is obtained from Swagelok for each use of 3rd party (non-swagelok purchased) product or service and for custom solution builds done on-site that are not covered under a Swagelok certification program as defined in process PR56. Certain projects are pre-approved as outlined below. For all other approvals, the distributor will submit a request through the Sourcing & Assembly Opportunity Assessment Form. Sourcing and custom solution opportunities that have been previously approved in the past three months are pre-approved provided that they are for the same end item part number and customer. Other sourcing and custom solutions service opportunities are pre-approved provided that ALL of the following conditions are met Our quality system is certified to the requirements of SQS. All internal manufacturing operations are covered by a Swagelok Certification program and will be performed by associates that have been certified. The project requires no outside processing or assembly services. All 3rd party products that contain pressure, affect wetted surfaces, or control or regulate fluid flow or pressure are customer approved (Ref. Section 7.5 c.). All 3rd party products do not compete with a Swagelok product and are not manufactured by a Swagelok competitor. No 3rd party products will be resold without being incorporated into an assembly. 13

14 Identification & Traceability We control and record unique identification of the product from receipt to customer delivery as required by the customer, industry, and/or Swagelok. Component and assembly traceability enables us to provide product information and certifications to customers and industries that require material traceability. Traceability records also enable the sales and service center to properly notify affected customers and mitigate risk resulting from improper manufacture. Records are maintained for all Swagelok orders and are traceable to the factory order number and product ID code. For orders from suppliers other than Swagelok, we maintain records traceable to the purchase order. Records are maintained for the following information for each Swagelok product affected: part number, factory order number (six-digit alpha numeric), and Swagelok product identification code (10-digit alpha numeric). Receiving and Shipping We ensure that the packages which are received are accurate and are in conformance with the purchase orders issued to suppliers. Receipts for items received are checked for accuracy, timeliness, and conformance to the purchase order. Our Receiving and Shipping process can be found in PR50 and PR52. We satisfy customer delivery requirements by packaging and shipping items to meet customer purchase order specifications. All shipments are checked twice by Connecticut Valve & Fitting Co. personnel to ensure that the shipments are in conformance with customer purchase orders. Packaging, Handling and Storage We ensure that handling, packaging, and storage of product is sufficient to prevent product from becoming damaged or mixed during processing and delivery to the customer as defined in process PR31. Processes involving packaging, handling, and storage help protect the Swagelok brand image by ensuring the proper product is delivered in good condition, and in packaging that has a consistent look and feel to all Swagelok customers worldwide. 14

15 Rentals We provide equipment to our customers for rental purposes. Such equipment is provided with a rental agreement which states the length of the rental, terms of the rental, and cost of the rental period. Connecticut Valve & Fitting Co. personnel also ensure that the equipment provided is in good working condition and is suitable for rental. Our process for Rentals can be found in PR34. Upon return of equipment, Connecticut Valve & Fitting Co. personnel will also thoroughly inspect the equipment, ensuring that there has been no damage done while in use as a rental and is suitable for the next customer request. 10CFR21 Reporting Upon our knowledge of a possible defect, we will submit the product to Swagelok under our Customer Action Process (CAP) procedure within 48 hours. Swagelok would assume responsibility for performing an evaluation of the defect for 10CFR 21 applicability under their QA Program. Measurement, Analysis and Improvement We plan, identify and implement measurement, analysis and continuous improvement processes to systematically do things better and improve overall customer satisfaction. Key measurements drive the results required to continuously improve operations & customer satisfaction. All processes critical to meeting or exceeding customer expectations are measured and monitored. 15

16 Customer Satisfaction We have established customer satisfaction processes to effectively communicate with customers to ensure requirements and expectations are understood, and that all comments and inquiries are heard and managed. This process monitors customers perceptions of our ability to meet requirements. Our customer satisfaction policy incorporates outbound customer satisfaction calls, the on time delivery report, and our return and CAP procedures. We strive for continuous improvement in satisfying our customer s requirements and expectations, promoting positive resolutions to customer issues, and improving business processes as a result of customer feedback. We have established a policy, objectives and a process that ensures complaints regarding products and service are handled in a consistent, timely and professional manner that satisfies the customer. Related information is analyzed to identify opportunities to improve products and business processes. This process can be found at MA7. Internal Auditing Our Internal Audit procedure defines our process to plan and conduct internal audits to verify the performance, conformance and effectiveness of the QMS. The responsibilities and requirements for managing (planning, conducting, reporting and maintaining records of) internal audit activities are documented in the Internal Audit Procedure which can be found at MA29. Internal audits are a primary tool of management to determine the effectiveness and suitability of the quality system. They are performed to ensure the quality system adequately defines the needs of the business; is effective and operating in accordance with specified requirements; documented procedures are practical, understood, followed, and meet specified requirements; quality activities and related results are documented and meet expectations; and the quality system is functioning in accordance with stated objectives. 16

17 Continuous Improvement Our continuous improvement process is documented and mapped as reflected in Document # MA16. We strive to maintain a methodical approach to this process through multiple processes, procedures, and programs. These include our Quality Policy, Quality Objectives, Internal Audits, Corrective Action, Preventative Action, Management Review, and Value Stream Mapping. All of these items contribute to Connecticut Valve & Fitting Co. s continual refining and evolving of customer satisfaction, positive problem resolution and streamlined business processes. Corrective Action A systematic attitude toward corrective action ensures the removal of existing nonconformities and defects of other undesirable situations to prevent reoccurrence (reactive). Corrective action is reacting to a problem and taking steps to eliminate the cause so the problem never reoccurs. Our procedure for Corrective Action can be found in Document # MA14. Preventative Action Preventive action eliminates the causes of potential nonconformities or other undesirable situations in order to prevent occurrence (proactive). Trend analysis is performed to prevent any reoccurrence of nonconformities and customer complaints to ensure continuous customer satisfaction. Our Preventive Action procedure ensures effective proactive practices for handling potential nonconformities. Actions will be based on the significance of the potential nonconformities identified and the potential impact on product performance and customer satisfaction. The Preventive Action can be found at Document # MA13. Non-Conforming Product Product that does not conform to requirements is identified and controls are in place to prevent unintended use or delivery. The Non-Conforming Product procedure identifies personnel responsible for identifying, controlling, documenting, dispositioning and processing nonconforming items. This procedure applies to all products, materials and work performed by, supplied by or supplied to us. This procedure can be found at MA21. Records of the type of nonconformities (e.g., defect code) and the actions taken to deal with the nonconformity are maintained. The Swagelok CAP process is used to return non-conforming Swagelok product to the factory. 17

18 Product Recall Our product recall procedure ensures the timely recalling of product from customers. This procedure can be found at MA21. Measures and Analysis We have developed and implemented processes for identifying, monitoring, measuring, and analyzing key product and process performance indicators. The indicators support the improvement of Connecticut Valve & Fitting Co. and Swagelok objectives. Metrics are used to monitor, analyze, and improve overall performance. The metrics include certain identified Swagelok-required metrics to be reviewed on a routine basis. We have planned for and implemented the monitoring, measuring, analysis, and improvement processes needed to: demonstrate conformity of product ensure conformity of the quality system continuously improve the effectiveness of the quality system We monitor and measure processes, using suitable methods to monitor and measure the business and manufacturing and quality system processes; demonstrating the ability of the process to achieve planned results and when planned results are not achieved, taking appropriate corrective action. We monitor and measure product characteristics to verify that product requirements have been met. We collect and analyze appropriate data to demonstrate the suitability and effectiveness of the business and quality system and to evaluate where the quality system can be improved. The analysis of data provides information relating to: customer satisfaction, conformity to product requirements. characteristics and trends of processes and products including opportunities for preventive action, and suppliers. 18

19 We have established metrics and assess performance of: non-conforming material, returns and recalls, and complaints. The following metrics are reported to Swagelok on a routine basis: complaints, returns, and recalls. 19

20 Document History Revision Level Date of Revision Description of Revision Revision Made By: 02 07/10/2009 Updated to reflect 9001:2008 and new organization chart Laura Klauser 03 12/14/2010 -Added introduction to include 10CFR50 Appendix B -Removed scheduling and invoicing -Updated name of Integrated Solutions to Custom Solutions Amy Rogers 20