QUALITY MANAGEMENT SYSTEM

Transcription

1 QUALITY MANAGEMENT SYSTEM Klein Steel Service, Inc UNCONTROLLED 4/11/11 Page 1 of 30 Revision Level: 001 Printed Date: 11/15/2013 1:02

2 Table of Contents Scope General Application Design and Development... Quality Management Systems References 2.1 Quality Management... General Management Systems Definitions Quality management System Definitions... General Requirements General Requirements Document Requirements General Quality Manual Document Control Control of Quality Records... Management Responsibility Management Commitment Customer Focus Quality Policy Planning Quality Management System Planning Responsibility, Authority & Communication Responsibility and Authority Management Representative Internal Communication Management Review General Review Input Review Output... Resource Management Provision of Resources Human Resources General Competence, Awareness & Training Infrastructure... UNCONTROLLED 4/11/11 Page 2 of 30

3 Table of Contents 6.4 Work Environment... Product Realization Planning of Product Realization Customer Related Processes Determination of Requirements Related to the Process Review of Requirements related to the product Customer Communication Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Production and Service Provision Validation of processes for production and service and provision Identification and traceability Preservation of Product Control of monitoring and measuring devices... Measurement, Analysis and Improvement General Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and measurement of processes Monitoring and measurement of product Control of Nonconforming Product Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action... UNCONTROLLED 4/11/11 Page 3 of 30

4 Introduction Klein Steel Service Inc. developed and implemented a Quality Management System (QMS) in order to document the company s best business practices, better satisfy requirements and expectations of its customers and improve the overall management of the company. The QMS of Klein Steel Service Inc. meets the requirements of the International Organization for Standardization (ISO). This system addresses the development, production, installation, and servicing of the company s products and services. This manual is divided into sections that correlate to QMS sections of ISO. Each section begins with a policy statement expressing Klein Steel Service Inc. obligation to implement the basic requirements of the referenced QMS section. Each policy statement is followed by specific information pertaining to the procedures that describe the methods used to implement the necessary requirements. This manual describes QMS and delineates authorities, responsibilities, and interrelationships of the personnel responsible for achieving the standards of this policy. The manual also provides procedures or references for all activities comprising the QMS to ensure compliance to the necessary requirements of the standard. This manual is to be used internally to guide the company s team members through the various requirements of the ISO standard that must be met and maintained in order to ensure customer satisfaction, continuous improvement and provide the necessary instructions that create an empowered work force. This manual is used externally to introduce our QMS to our customers, suppliers and other external organizations or individuals. The manual is used to familiarize them with the Klein Steel Service Inc. controls that have been implemented and to assure them that the integrity of the QMS is maintained and focused on customer satisfaction and continuous improvement. UNCONTROLLED 4/11/11 Page 4 of 30 Revision Level: 001 Printed Date: 11/15/2013 1:02

5 Scope Klein Steel Service Inc. Quality Manual 1.1 General The quality manual outlines the policies, procedures and requirements of the Quality Management System (QMS). The system is structured to comply with the conditions set forth in the International Organization for Standardization (ISO) and to comply with market specific customer needs. The intent of these policies and procedures is to demonstrate Klein Steel s ability to consistently provide product that meets or exceeds customer and applicable regulatory requirements and to assure complete customer satisfaction through the effective application of the quality system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. 1.2 Application Klein Steel Service Inc. has determined that the following requirements are not applicable to the operations at this site and are documented as exclusions: 7.3 Design and Development- UNCONTROLLED 4/11/11 Page 5 of 30

6 General Management System References Klein Steel Service Inc. Quality Manual 2.1 Quality Management System References The following documents were used as reference during the preparation of the Quality Management System: American National Standard ANSI/ISO/ASQ Q , Quality Management Systems - Vocabulary American National Standard ANSI/ISO/ASQ Q , Quality Management Systems Requirements American National Standard ANSI/ISO/ASQ Q , Quality Management Systems Guidelines for performance Improvements American National Standard ANSI/ISO/ASQ Q , Quality Management Systems Guidelines for Quality Plans UNCONTROLLED 4/11/11 Page 6 of 30 Revision Level: 001 Printed Date: 11/15/2013 1:02

7 General Management Systems Definitions Klein Steel Service Inc. Quality Manual 3.1 Quality Management System Definitions This section is for definitions unique to Klein Steel Services Inc. Customer owned property - Any type of instrumentation, accessories, manuals, blueprints/or technical drawings, or shipping containers that belong to a customer. Customer supplied product - Any type of service or material supplied to be utilized in the manufacture, modification or repair of customer-owned property. Product The end item result of meeting all purchase order terms and conditions. (i.e: manufactured goods, merchandise, services etc.) Quality Records Documentation of those activities in which records of said activities must be maintained will be specified in the procedure or work instruction level documents, as applicable. Work Order The Work Order is the printed document package that defines the sequence of operations to be performed in the execution of a specific work order including inspection points. This package also contains the appropriate inspection forms, material certificates and other data gathered as the part progresses thru processing. This document package is enclosed in a clear envelope which also contains other pertinent in-process documentation that travels with the parts on the shop floor. Job Folder The job folder is the final collection point for all paperwork associated with a specific job that serves as the historical documentation for the work performed. All pertinent documents will be contained in the folder; drawings, work order routers, material certifications, inspection sheets. The job folder is considered the historical record of note for each job. Quality Management System A management system to direct and control an organization with regard to quality. Quality Objective An objective to be sought, or aimed for, related to quality. Material Review - Material review is the activity performed by the Material Review Board to determine the disposition of products that do not meet specification. This activity is performed by shop management and Quality personnel. UNCONTROLLED 4/11/11 Page 7 of 30

8 General Requirements Klein Steel Service Inc. Quality Manual Section 4: General Requirements UNCONTROLLED 4/11/11 Page 8 of 30 Revision Level: 001 Printed Date: 11/15/2013 1:02

9 General Requirements Klein Steel Service Inc. Quality Manual 4.1 General requirements Klein Steel Service Inc. has established, documented and implemented a Quality Management System (QMS) in accordance with the requirements of ISO. The system is maintained and continually improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action and management review. To design and implement the QMS, Klein Steel Service Inc. has: Identified the processes needed for the QMS and their application throughout the organization and documented them on the Process Flow Diagram at the end of this section of the Quality Manual. Determined the sequence and interaction of these processes, and illustrated them on the Process Flow Diagram. Determined criteria and methods needed to ensure that the operation and control of the processes are effective, and documented them in quality plans, work instructions and the Measuring, Monitoring and Analysis Table. Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes. Established systems to monitor, measure and analyze these processes. Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes. 4.2 Documentation Requirements General The QMS documentation includes: Documented quality policy and quality objectives This Quality Manual Documented procedures Documents identified as needed for the effective planning, operation and control of our processes Quality records Quality system requirements UNCONTROLLED 4/11/11 Page 9 of 30

10 General Requirements Klein Steel Service Inc. Quality Manual Quality manual This Quality Manual has been prepared to describe Klein Steel Service Inc. QMS. The scope and permissible exclusions of the QMS are described in section one of this manual. Each section of the manual references documented QMS procedures relating to the requirements outlined in that section. The Process Flow Diagram at the end of Section Four provides a description of the interaction between the processes of the QMS system Control of documents All QMS documents are controlled according to the Document Control Procedure. This procedure defines the process for: Approving documents for adequacy prior to issue. Reviewing and updating as necessary and re-approving documents. Ensuring that changes and current revision status of documents are identified. Ensuring that relevant versions of applicable documents are available at points of use. Ensuring that documents remain legible and readily identifiable. Ensuring that documents of external origin are identified and distribution is controlled. Preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose. Ensuring that document changes with customers and/or regulatory authorities are coordinated in accordance with contract or regulatory requirement Control of quality records Quality records are maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. The records are maintained according to the Control of Quality Records Procedure. This procedure requires that quality records remain legible, readily identifiable and retrievable. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of quality records. UNCONTROLLED 4/11/11 Page 10 of 30

11 Example of Klein Steel Service s Manufacturing Process Flow: Sale Order Request Customer Requirements Reviewed Meet Customer Requirements? NO YES Order Accepted Price quotation Purchase Order Received Order not accepted Receive & Inspect Materials Purchase Materials Control customersupplied materials Yes Customer-supplied materials? Schedule Production NO Materials approved? YES Process, test, & inspect In-Process & final tests OK? YES Packaging Ship to Customer Customer Feedback NO NO Quarantine & disposition Quarantine & disposition Concession? YES Concession or downgrade? YES NO Dispose of, or return to supplier/customer NO Rework YES Retest OK? NO Dispose of UNCONTROLLED 04/11 Page 11 of 30

12 Management Responsibility Section 5: Management Responsibility UNCONTROLLED 04/11 Page 12 of 30

13 Management Responsibility 5.1 Management commitment Senior management is charged with implementing the Quality Management System (QMS). Senior management provides the vision and strategic direction for the growth of the QMS, and established quality objectives policy. To continue to provide leadership and show commitment to the improvement of the QMS, management is responsible for the following. Communicate the importance of meeting customer, statutory, and regulatory requirements. Establish strategic objectives. Establish the quality policy. Conduct monthly management reviews. Ensure the availability of resources. Define and delegate the established Business objectives responsibilities. Continually measure and monitor Klein s Business objectives to insure they are being achieved. 5.2 Customer focus Klein Steel Service Inc. strives to identify current and future customer needs, to meet customer requirements and expectations. Senior management ensures that customer requirements are understood and met, by requiring compliance with customer communications. Customer requirements are reviewed, converted into internal processes, and communicated to the appropriate people in our organization. UNCONTROLLED 04/11 Page 13 of 30

14 Management Responsibility 5.3 Quality policy Klein Steel Quality Policy As a distributor and processor of metals, Klein Steel Service Inc. is committed to providing the highest level of quality products and services to all customers. Our image is a reflection of our mutual respect for each other, our customers and the approach we take toward being a superior performer. We measure the success of our customers and we strive to be best in class with quality, on time delivery, continuous improvement, productivity, safety and accuracy. UNCONTROLLED 04/11 Page 14 of 30

15 Management Responsibility 5.4 Planning Quality objectives Quality objectives are established to support our organization s efforts in achieving our quality policy and reviewed annually for suitability. Safety Accuracy Product Quality Responsive to schedule changes/on-time delivery Productivity Quality objectives are measurable and reviewed against performance goals Quality management system planning The quality system has been planned and implemented to meet our strategic objectives and the requirements of the ISO standard. Quality planning takes place as changes that affect the quality system are planned and implemented. 5.5 Responsibility, authority and communication Responsibility and authority Organizational charts have been established. (See HR for the latest). Job descriptions define the responsibilities and authorities of each of the positions on the organizational chart. Job descriptions and the organizational chart are reviewed and approved by senior management for accuracy. UNCONTROLLED 04/11 Page 15 of 30

16 Management Responsibility Management representative The Manager of Quality has been appointed as management representative. As management representative, he has the following responsibility and authority: Ensure that processes needed for the QMS are established and implemented. Supported by the management team, maintain the momentum with QMS performance. Promote awareness of customer requirements throughout the organization. With identified senior managers, liaison with external parties such as customers or auditors on matters relating to the QMS Internal communication Processes are established for communication within the organization. Methods of communicating the effectiveness of the QMS include verbal communication between management and team members, regular staff meetings, after actions reviews and an annual management review. This communication may take the form of review of the quality objectives, results of both internal and customer audits, and new business opportunities. 5.6 Management review General Klein s management continually reviews the QMS to insure it is consistent and up to date with our ever improving business system design. As changes happen throughout our evolving business system updates are an ongoing experience. UNCONTROLLED 04/11 Page 16 of 30

17 Management Responsibility Review input Assessment of QMS is based on a review of information inputs to management review. These inputs include the following: Results of audits. Customer feedback. Process performance and product conformity. Company level quality data. Status of preventive and corrective actions. Follow-up actions from previous management reviews. Planned changes that could affect the quality management system. Recommendations for improvement Review output During these review meetings, management will identify appropriate actions to be taken regarding the following issues: Improvement of the effectiveness of QMS and its processes. Improvement of product related to customer requirements. Priorities and resource requirements. Responsibilities for required actions are assigned to members of the management review team. UNCONTROLLED 04/11 Page 17 of 30

18 Resource Management Section 6: Resource Management UNCONTROLLED 4/11/11 Page 18 of 30 Revision Level: 001 Printed Date: 11/15/2013 1:02

19 Resource Management 6.1 Provision of resources Klein Steel Service Inc. has implemented a Quality Management System (QMS) that complies with the ISO standard. This implementation was achieved with management commitment and with sufficient resources for the implementation. To effectively maintain and continually improve the system, management determines and provides necessary resources addressed in the annual budget process. 6.2 Human resources General To ensure competence of our personnel, appropriate qualifications and routine required training provide the competence required for each position. New team members are given an orientation. Team Member Manual, Safety and Loss Prevention Program Manual, and Hazard Communication Program are addressed in our training Competence, awareness and training Team member qualifications are reviewed upon hire, when an team member changes positions or the requirements for a position change. If any differences between the team member s qualifications and the requirements for the job are found, training or other action is taken to provide the necessary competence for the job. The results are then evaluated to determine if they were effective. Training and evaluation are conducted according to the Training Procedure. All team members are trained and certified on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. 6.3 Infrastructure To meet strategic objectives and product requirements, Klein Steel Service Inc. has determined the infrastructure required. The infrastructure has been provided, and includes buildings, workspace, utilities, process equipment and supporting services. As new infrastructure requirements arise, they will be documented in quality plans. Existing infrastructure is maintained to ensure product conformity. Requirements are identified and prioritized in the annual budget process. 6.4 Work Environment A work environment suitable for achieving superior product conformance is maintained and managed for continuing suitability. UNCONTROLLED 04/11 Page 19 of 30

20 Measurement, Analysis and Improvement Section 7: Product Realization UNCONTROLLED 4/11/11 Page 20 of 30 Revision Level: 001 Printed Date: 11/15/2013 1:02

21 Measurement, Analysis and Improvement 7.1 Planning of product realization Quality planning is required before new products or processes are implemented. The quality planning will take place as a new project or customer is accepted. During this planning, management or assigned personnel identify: The quality objectives and customer requirements for the product. Processes, documentation and resources required. Verification, validation, monitoring, inspection and test requirements. Criteria for product acceptance. Criteria for meeting realization processes and meeting product requirements. The output of quality planning includes documented quality plans and processes. 7.2 Customer-related processes Determination of requirements related to the product Klein Steel Service Inc. reviews customer requirements before acceptance of an order. Customer requirements include those: Requested by the customer. Required for delivery and post-delivery activities. Not stated by the customer but necessary for specified use or known and intended use. Statutory and regulatory requirements related to the product. Additional requirements determined by Klein Steel Service. UNCONTROLLED 04/11 Page 21 of 30

22 Measurement, Analysis and Improvement Review of requirements related to the product Klein Steel Service Inc. has a process in place for the review of requirements related to the product. The review is conducted before the order is accepted. The process ensures that: Product requirements are defined. Contract or order requirements differing from those previously expressed are resolved. Klein Steel Service Inc. has the ability to meet the defined requirements. Records are maintained showing the results of the review and any actions arising from the review. Where a customer does not provide a documented statement of requirements, the customer requirements are confirmed before acceptance. When product requirements are changed, Klein Steel Service Inc. communicates changes to relevant personnel and amends relevant documents. Risks have been evaluated (e.g., new technology, short delivery time line, etc) Customer communication Klein Steel Service Inc. has implemented Customer Related Processes for communicating with customers in relation to: Product Information. Enquiries, contracts and order handling, including modifications. Customer feedback, including customer complaints. UNCONTROLLED 04/11 Page 22 of 30

23 Measurement, Analysis and Improvement 7.4 Purchasing Purchasing process A documented procedure is followed to ensure that purchased product conforms to the specified purchase requirements. The procedure outlines the extent of control required for suppliers. Suppliers are evaluated and selected based on their ability to supply product in accordance with requirements as outlined in the procedure. Criteria for selection, evaluation and re-evaluation are documented in the procedure. Records of the evaluation and any necessary actions are maintained as quality records Purchasing information Purchasing information describes the product to be purchased, including where appropriate: Requirements for approval of product, processes and equipment. Requirements for qualification of personnel. QMS requirements. The purchasing documents are reviewed to ensure the adequacy of requirements before orders are placed with the supplier Verification of purchased product The Purchasing Procedure describes the process used to verify that purchased product meets specified purchase requirements. If Klein Steel Service Inc. or the customer will perform verification at the supplier s premises, the verification arrangements and method of product release are documented in the purchasing information. UNCONTROLLED 04/11 Page 23 of 30

24 Measurement, Analysis and Improvement 7.5 Production and Service Provision Validation of processes for production and service provision Klein Steel Service Inc. does not have any processes that cannot be verified by subsequent measurement or functional testing. Special processes are subcontracted and requirements for validation of special processes are communicated to subcontractors in accordance with our Purchasing and Supplier Control Procedure Identification and traceability Klein Steel Service Inc. identifies the product throughout product realization according to the Identification and Traceability Process. Product is identified with respect to monitoring and measurement requirements. Klein Steel Service Inc. controls and records the unique identification of the product wherever traceability is applicable. Klein Steel Service Inc. exercises care with customer property while it is under the organization's control or being used. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer immediately and records maintained Preservation of product Klein Steel Service Inc. preserves the conformity of product during internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product. UNCONTROLLED 04/11 Page 24 of 30

25 Measurement, Analysis and Improvement 7.6 Control of monitoring and measuring devices Klein Steel Service Inc. will determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. A documented procedure outlines the process used to ensure that monitoring and measurement to be carried out are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment is: Calibrated or verified at required intervals, or prior to use, against measurement standards traceable to international or national measurement standards. Adjusted or re-adjusted as necessary. Identified to enable the calibration status to be determined. Safeguarded from adjustments that would invalidate the measurement result. Protected from damage and deterioration during handling, maintenance and storage. In addition, Quality Assurance assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. Klein Steel Service Inc. takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. UNCONTROLLED 04/11 Page 25 of 30

26 Measurement, Analysis and Improvement Section 8: Measurement, Analysis and Improvement UNCONTROLLED 04/11 Page 26 of 30

27 Measurement, Analysis and Improvement 8.1 General Klein Steel Service Inc. plans and implements the monitoring, measurement, analysis and improvement processes as needed. To demonstrate conformity of the product. To ensure conformity of QMS. To continually improve the effectiveness of QMS. These processes are identified in documented procedures and include determination of applicable methods, including statistical techniques and the extent of their use. 8.2 Monitoring and Measurement Customer satisfaction As one of the measurements of the performance of QMS, Klein Steel Service Inc. monitors information relating to customer perception as to whether the organization has fulfilled customer requirements Internal audit Klein Steel Service Inc. conducts internal audits at planned intervals to determine whether the Quality Management System: Conforms to the planned arrangements, to the requirements of this International Standard and to the quality management system requirements established by the organization. Is effectively implemented and maintained. An audit program has been designed and implemented and identifies an audit schedule based on the importance of the areas to be audited, as well as the UNCONTROLLED 04/11 Page 27 of 30

28 Measurement, Analysis and Improvement results of previous audits. The audit criteria, scope, frequency, methods, responsibilities and requirements for planning and conducting audits, and for reporting and maintaining results, are defined and documented in the Internal Audit Procedure. The management responsible for the area being audited is responsible for ensuring that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results Monitoring and measurement of processes Klein Steel Service Inc. applies suitable methods for monitoring and, where applicable, measurement of QMS processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product Monitoring and measurement of product Klein Steel Service Inc. monitors and measures the characteristics of the product to verify that product requirements are fulfilled. This is carried out at appropriate stages of the product realization process. Evidence of conformity with the acceptance criteria is maintained. Records indicate the person authorizing release of product. Product release and service delivery does not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer. 8.3 Control of Nonconforming Product Klein Steel Service Inc. ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in the Control of Nonconforming Product Procedure. UNCONTROLLED 04/11 Page 28 of 30

29 Measurement, Analysis and Improvement 8.4 Analysis of Data Klein Steel Service Inc. determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of QMS and to evaluate where continual improvement is required or appropriate. The analysis of data provides information relating to: Customer satisfaction. Conformance to product requirements. Characteristics and trends of processes and products including opportunities for preventive action. Suppliers. 8.5 Improvement Continual improvement Klein Steel Service Inc. continually improves the effectiveness of QMS through the use of: Ex- CPI, CKS, Internal Lean events, AARs and multiple other actions Corrective Action Klein Steel Service Inc. takes action to eliminate the cause of nonconformities in order to update procedures and prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered. A documented Corrective Action Procedure defines requirements for: Reviewing nonconformities (including customer complaints). Determining the causes of nonconformities. Evaluating the need for action to ensure that nonconformities do not recur. Determining and implementing action needed. Records of the results of action taken. Reviewing corrective action taken. UNCONTROLLED 04/11 Page 29 of 30

30 Measurement, Analysis and Improvement Preventive action Klein Steel Service Inc. determines action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. A documented Preventive Action Procedure defines requirements for: Determining potential nonconformities and their causes. Evaluating the need for action to prevent occurrence of nonconformities. Determining and implementing action needed. Records of results of action taken. Reviewing preventive action taken. UNCONTROLLED 04/11 Page 30 of 30