HFI Fluid Power Products Quality Manual Revision # 5 dated 02/07/10. HFI FLUID POWER PRODUCTS A Division of Hydraulic Fittings, Inc.

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1 HFI FLUID POWER PRODUCTS A Division of Hydraulic Fittings, Inc. ISO QUALITY MANUAL SCOPE HFI Fluid Power Products is a full line stocking distributor/manufacturer for both hydraulic and pneumatic products. HFI manufactures a complete line of quality hydraulic fittings and adapters including metric standards and specials adhering to all JIC, SAE, and ISO standards. Hydraulic tube and hose assemblies are fabricated at our modern production facilities utilizing the latest CNC manufacturing and inspection equipment. REDUCTIONS IN SCOPE The following elements of ISO are not applicable to the organization's quality system. Justification for exclusion can be found in the applicable section of this manual Exclusions: 7.3 Racine Wisconsin locations included in the scope of this registration are: 1210 Washington Avenue 1220 Washington Avenue 1232 Washington Avenue 1230 Racine Street This manual defines the company's policies in relation to the ISO standards. The Company Management endorses the policies contained in this manual and certifies that this manual correctly describes the company s quality system. Robert G. DeMicchi Controlled Copy _x_ or Uncontrolled Copy Page 1 of 17

2 1 Scope 1.1 General The product scope and the quality system scope are printed on the cover of this manual. 1.2 Application Elements of the ISO 9001:2008 standards not applicable to the organization's quality system are to be identified as such in the quality system scope printed on the cover of this manual. These exclusions are justified in the associated section of this manual and are reviewed for possible inclusion in the quality system during management review (section 5.6). 2 References ANSI/ISO/ASQ Q Quality management systems - Requirements 3 Terms and definitions For the purposes of the organization's Quality System, the terms and definitions given in ISO Quality Management Systems - Fundamentals and Vocabulary apply. 4 Quality management system 4.1 General requirements The organization's Quality Management System has been developed and documented in this manual to ensure that product conforms to customer requirements. This manual identifies the elements needed for an effective Quality Management System and their application throughout the organization. The sequence and interaction of processes is defined in this manual and associated procedures. Effective methods have been implemented to operate and control all identified processes. The structure of the Quality system ensures adequate and effective Management (see section 5) resources (section 6), product/production process control (see section 7), Monitoring, measurement, and analysis of operations (see section 8), and a process of continuous improvement throughout the structure of the system. Processes that have been outsourced are controlled by defined methods per section 7.4. The Quality Management System is implemented, maintained, and improved in accordance with International Standards as referenced in section Documentation requirements General The organization s quality system is documented to ensure compliance with international quality standards (section 2) and to provide a means to conduct training (section 6.2.2) and assessment (section 8.2.2) of the quality system and its effectiveness. Page 2 of 17

3 The organizations quality system includes a statement of a quality policy and objectives (section 5.2 and W policy poster), a quality manual (this document), procedures, work instructions, and records (see associated master lists) either required by the ISO standards or needed to ensure the effective planning, operation, and control of the organization s processes Quality manual This document describes the elements of the organization's quality management system and how they interact (see overview in section 4.1 as well as references internal to this quality manual and references to system level procedures provided in the body of this document). Reductions in scope are identified and justified in the applicable section of this manual and increases or decreases in scope are determined during management review (section 5.6) and then updated in this document. Changes to the quality manual may only be made by directive of the Management Review Committee (MRC) with the approval of the President. Quality manual (policy) changes are recorded in the quality manual revision history (Appendix II of this manual) Control of documents Documents, whether in hard copy form or electronic media, associated with the Quality System are maintained in a controlled environment. New and changed Documents are, reviewed, updated, and approved by authorized personnel prior to issue. This review is conducted to ensure continued compliance with Quality System requirements, International Quality Standards, and for appropriateness to the process(es) affected (per section 5.4.2). Documents of external origin required for the effective planning and operation of the company s quality system are identified and their distribution is controlled per procedures. Mechanisms for the distribution of current documents and the disposition of obsolete documents are detailed in control procedures. ref - P-050 Document and Data Control When customer drawings or specifications reference other documents, currently released editions of those documents, or customer interpretations of the specifications, are made available at appropriate locations. Master lists identify the latest release of procedures, forms, and work instructions to preclude the use of invalid or obsolete documents. ref - F-000 Forms Master List ref - P-000 Procedure Master List ref - W-000 Work Instruction Master List ref - S-000 Standards Master List Process, product knowledge/experience, plus supplier and customer supplied information necessary for the control of processes and needed to ensure product quality are computerized in order to provide immediate access to applicable employees and departments. This computer data is controlled through limited access to maintenance screens and backups of computer files. Computer data changes/updates are only made by authorized, trained personnel to ensure system and data integrity ref - P-050 Document and Data Control Page 3 of 17

4 4.2.4 Control of records Quality records are controled in order to provide evidence of the successful operation of the quality system and remedial actions taken to correct nonconformances. Quality records may be in paper or electronic form and are to be legible and retrievable by internal and external auditors as well as individuals requiring access to perform their job functions. ref - P-160 Quality Records Individual procedures identify the quality records to be retained, retention periods, maintenance requirements, and custodial locations. 5 Management responsibility 5.1 Management commitment Top Management has demonstrated its commitment to the implementation, maintenance, and improvement of the organization's quality management system through the establishment of the Quality Policy, Quality Objectives, and this Quality Manual. Further, Top Management continues its support through ongoing involvement in the management review process, providing resources and direction to ensure the continuing effectiveness of the system to meet customer requirements and achieve customer satisfaction. 5.2 Customer focus Customer requirements are determined and reviewed during the quote process and/or upon receipt of an order (section and 7.2.2). Customer confidence in ensured through a process that converts customer needs and expectations into requirements to be fulfilled by the organization's quality management system (section 7.3). The organization s aim is to enhance customer satisfaction by meeting or exceeding the customer s requirements. Customer satisfaction is measured (section 8.2.1). 5.3 Quality policy We will attain total customer satisfaction through continuous improvement of our distribution, manufacturing, marketing, sales, and customer service operations. The success of our company depends upon our ongoing commitment to quality through teamwork, education, communication, and consistency of all HFI employees, processes, and products. Top Management takes responsibility for ensuring the quality policy and the associated quality objectives (section 5.4.1) are understood and posted throughout the organization (section 6.2). ref - W-010 Quality Policy and Responsibilities Poster Understanding of the organization s quality policy is verified during internal auditing (section 8.2.2) Page 4 of 17

5 The quality policy is reviewed for continuing suitability during Management Review (section 5.6) 5.4 Planning Quality objectives To continually: Improve customer satisfaction reduce customer complaints and returns reduce internal rejects improve on-time delivery Top management takes responsibility for ensuring the quality objectives are measurable and consistent with the quality policy and are understood throughout all levels of the organization (section 6.2). Understanding of the organization s quality objectives are verified during internal auditing (section 8.2.2). ref - W-010 Quality Policy and Responsibilities Poster Measurements associated with quality objectives are reviewed during each management review where goals for each are established for the following year. The status of results associated with quality objectives are communicated to employees. ref - P-010 Management Review Quality management system planning The company's overall Quality Plan is spelled out in detail in this manual and associated procedures. Together, these documents represent our overall plan to ensure operational consistency, prevent non-conformances, and achieve the company s stated quality objectives. Action plans needed to ensure the achievement of quality objectives (including any necessary additions or reductions in the scope of the quality management system) are documented in management review (section 5.6) Organizational and quality management system changes always require changes to documentation and are therefore e conducted per procedures associated with document changes (section 4.2.3) in a manner that ensures the overall operation of the system is maintained during the change process. Quality plans for specific products/processes are documented in the production control routing system, internal and/or customer drawings, and associated test and inspection procedures and work instructions (section 7.5). Internal Quality Plans are initiated by the Production and Quality Management Committee (PQMC) when considering expanding manufacturing capabilities based on market potential. Quality plan requirements are detailed in documented procedures and records of quality plan formulation are maintained in the form of checklists associated with the procedures (section 7.1). When the Company decides to "no-quote" a product due to its incompatibility with current manufacturing processes, no quality plan checklist is created. Note: Design and development planning is not applicable to this organization. Page 5 of 17

6 5.5 Responsibility, authority and communication Responsibility and authority Top Management has identified, assigned, and communicated specific responsibilities and authorities for the operation and maintenance of the organization's Quality System. Processes have been put in place to ensure employees are aware of the responsibilities and authorities they have. ref - W-010 Quality Policy and Responsibilities Poster The inter-relationships of individuals and departments within the organization are outlined in the company organization chart (see appendix I). Responsibilities and authorities associated with specific procedures and the interrelationships of individuals with responsibilities within specific procedures are identified in the procedures themselves Management representative The president has appointed a management representative with the responsibility and authority to ensure the establishment, implementation, and maintenance of the quality system and to ensure the awareness of customer and quality system requirements throughout the organization, ref - W-010 Quality Policy and Responsibilities Poster The management representative reports on the status and performance of the quality system during management review (section 5.6) Internal communication The organization has established procedures for effective communication regarding the quality management system and its effectiveness. Employees are also informed of the affect their jobs have on the quality objectives and overall operation of the quality system (per 6.2.2). Lines of communication and department/staff interfaces needed to ensure process consistency are outlined in procedures specific to the processes involved. Employee input on improvement opportunities and identification of needed organizational skills is collected during the internal auditing process (section 8.2) 5.6 Management review General The management review committee (MRC) conducts an annual review of the entire quality system to ensure its continued suitability and effectiveness. The quality policy and quality objectives, along with the results of internal audits, are reviewed during this process. Critical quality system elements are reviewed quarterly through a formal meeting of the management review committee. ref - P-010 Management Review Review input At a minimum, management review includes information on the following: Page 6 of 17

7 Reduction or expansion of quality system scope (per 1.0) Quality policy review for continued suitability (per 5.3) Quality objective review and establishment of goals (per 5.4.1) Results of customer satisfaction data (satisfaction/dissatisfaction with current services and customer overall needs and expectations that are to be translated into requirements for Quality System improvements) (per 8.2.1) Status of, and trends in, corrective/preventive, actions (per and 8.5.3) Results of internal audits and potential process, organizational, or operational improvements identified during the audit process and establishment of the next 12 month audit schedule (per 8.2.2) Training effectiveness assessment (per 6.2.2). Assessment of infrastructure adequacy and infrastructure plans (per 6.3) Continuous improvement results, plans, and projects (per 8.5.1) Status, plans, and initiation of improvement actions (per 8.5.1) which includes followup on actions from previous management reviews Review output Directives, organizational changes, quality system changes, continuous improvement projects, product/process changes, audit schedule changes/additions, resource studies/acquisitions, and corrective/preventive actions resulting from the review are processed through the action request system (section 8.5) 6 Resource management 6.1 Provision of resources Resources for the establishment and maintenance the Quality System to ensure product conformity and the organization's ability to meet customer requirements are provided as needed on an ongoing basis. An overall resource adequacy assessment takes place during the management review process (section 5.6). 6.2 Human resources General Personnel are assign positions of responsibility in the quality management system only after demonstrating the appropriate level of education, training, skill and/or experience necessary to effectively execute the assigned tasks (section 6.2.2) Competence, training and awareness Employment of qualified staff is achieved by job specific pre-employment skills testing and supplemented by on- the-job training, internal classes, outside courses, and seminars where appropriate. Each job has specified and documented procedure and work instruction training requirements. Records of training are maintained. ref - P-180 Training System Training effectiveness is assessed during management review and on an ongoing basis in association with internal auditing (sections 5.6 and respectively). Page 7 of 17

8 Each employee is aware of the elements of the organization's quality management system and their role in its effective operation and the quality objectives their jobs affect. ref - P-180 Training System Employee input on needed organizational skills is collected during the internal auditing process (section 8.2) Job descriptions, where they exist, are used in the performance assessment process and are not part of the quality management system. 6.3 Infrastructure Infrastructure elements are defined and undergo periodic audit and assessment. This assessment is carried out in conjunction with the annual management review (section 5.6). Equipment to be used in production and for handling products and materials is verified as capable of producing to desired standards prior to use. Production equipment is maintained according to a documented maintenance schedule. ref - P-091 Preventive Maintenance 6.4 Work environment Human and physical factors of the work environment are defined and undergo periodic audit and assessment. This assessment is carried out in conjunction with the annual management review (section 5.6). 7 Product realization 7.1 Planning of product realization There is a formal, documented multi-functional system to plan production activities. Quality plans which includes the identification and documentation of associated inspection, measurement, acceptance, resource, process, and records requirements are part of the planning process. Changes are controlled via formal documented procedures and concessions, where applicable, are documented via contract changes and records of communication with the customer (section 7.2). Determination of the measurements to be made, the accuracy requirements and selection (specify) of the appropriate measuring and monitoring devices that are capable of the necessary accuracy and precision is achieved through quality assurance involvement in the planning process. ref - P-011 PQMC ref - P-020 Quality Planning Quality plan requirements are detailed in documented procedures and records of quality plan formulation are maintained in the form of checklists associated with the procedures. ref - P-020 Quality Planning Individual product production processes are planned per procedures associated with section 7.5 and changes to processes are planned and executed according to procedures associated with section Page 8 of 17

9 7.2 Customer related processes Determination of requirements related to the product A formal, documented process ensures customer requirements are adequately understood. ref - P-030 Contract Review Inside Sales determines if existing processes are capable of fulfilling the requirements on customer orders for manufactured goods. Written quotes are provided for manufactured items and require customer approval prior to the initiation of production. First piece approval by the customer is provided for when specified in the contract. Any customer initiated changes to the quote are resolved through communications with the customer prior to the release of a shop order. Exception: written quotes are not provided on repeat orders. ref - P-030 Contract Review Changes to customer contracts, individual sales orders, or to component specifications as well as differences between quotes and sales orders, are confirmed/resolved through communications with the customer and are documented. ref - P-030 Contract Review Review of requirements related to the product A formal, documented process ensures customer requirements are effectively translated into pick tickets for shipment, purchase orders for non-stock items and/or raw materials, and into shop orders for production. The review process and subsequent follow-up actions are recorded as described in control procedures. ref - P-030 Contract Review Customer communication Arrangements for communication with customers have been implemented with the aim of meeting customer requirements. Communication requirements and records of customer communication are defined in documented procedures associated with various clauses of the organization's quality management system: Communication on product information/orders/and amendments (section 7.2.1) Communication on technical data pertaining to measuring and monitoring devices (section 7.6) Communication related to customer property (section 7.5.4) Communication relating to nonconforming product (section 8.5.2) Customer complaints are handled and resolved per documented procedures, ref - P-140 Corrective and preventive action 7.3 Design not applicable HFI Fluid Power Products does not design products. 7.4 Purchasing Purchasing process Page 9 of 17

10 The organization has instituted processes to ensure raw materials, components, and services obtained from suppliers conform to specified requirements and that suppliers are capable of meeting the quality and delivery requirements. ref - P-060 Purchasing Selection of suppliers is based on their ability to meet specified requirements. A master list of approved suppliers is maintained. Raw materials such as hydraulic tubing, hydraulic hose, and bar stock require documented certification upon delivery and traceability to HFI's PO and the supplier s lot. Where applicable, purchased materials satisfy current government and safety constraints on restricted, toxic and hazardous materials. ref - P-060 Purchasing Purchasing information Purchasing documents supplied to the subcontractor clearly identify and describe the product ordered, the requirement date, and where applicable, relevant technical data to assure that quality objectives are met. Purchasing documents are reviewed and approved for adequacy of specified requirements prior to release to the subcontractor. ref - P-060 Purchasing Requirements for suppliers to operate specific types of quality management systems are determined during the management review process (section 5.6) Verification of purchased product Raw material receiving procedures ensure the item(s) are of the correct material, dimensions, and quantity. Inspection requirements, including the confirmation of material certifications when required, are contained in the PO and verified upon receipt. Discrepancies are resolved prior to the materials being placed in inventory or given to production. Regardless of the urgency, material is not released to production or for shipment until all required inspections have been completed. Ref - P-100 Inspection and test The company reserves the right to perform source inspection of any raw material or outside service performed for any contract or purchase order issued to a supplier. When applicable, verification requirements will be specified in the purchasing documents. Customer verification of product at the supplier's or HFI's premises can be afforded to the customer where specified by contract. Customer verification is not used as evidence of effective control of quality by the supplier nor does it absolve HFI from providing acceptable product to the customer. 7.5 Production and service provisioning Quality plans for specific products are documented in the production control routing system, internal and/or customer drawings, and associated test and inspection procedures and work instructions (section 7.5). Servicing and installation are not applicable to the scope of this registration Control of production provisioning Page 10 of 17

11 Shop orders and supporting documentation contain all information needed to enable the facility to produce to output specifications mandated by the customer and/or internal standards. Compliance with documented procedures and work instructions is mandatory for all employees. The quality plan for process control is documented in formal procedures. Changes to base orders and routings are processed per documented procedures. ref - P-090 Process Control Availability and use of suitable measuring and monitoring equipment is controlled (section 7.6). Statistical process control is utilized when specified by customer contract or identified by quality assurance as necessary to control product characteristics, or are implemented in response to corrective or preventive action requirements or continuous improvement efforts. Statistical process control techniques carried out by trained personnel. Procedures address the identification, use and training of statistical process control methodology. ref - P-200 Statistical Techniques The maintenance of production equipment is defined in procedures (section 6.3) Control of Distribution operations is defined and documented (section 7.5.5) Validation of processes for production and service provisioning Where the resulting quality of a process cannot be verified by subsequent inspection or testing, they are validated only by qualified operators that continually monitor specified (special) process controls and/or process parameters. ref - P-090 Process Control Identification and traceability Products/materials are identified by suitable means by customer part number or are assigned unique HFI part numbers in order to maintain identification all stages of storage, handling, shipment, and receipt by the customer. Unique shop order numbers are used to maintain identification throughout the manufacturing process. Products are traceable to specific customer drawings and revisions levels. Distribution inventory is identified by vendor or HFI part number and traceability is provided upon customer request only ref - P-080 Identification and Traceability All products awaiting inspection is specifically identified as such. All items passing inspection and test are appropriately identified for the next stage of production, for stock, or for shipment to a customer. Non-conforming items are appropriately identified and/or segregated in order to prevent inadvertent use or shipment. ref - P-120 Inspection and Test Status Customer property In addition to normal handling, verification and storage procedures, the company has developed methods to specifically identify and control customer raw materials, tools and documents to protect them from loss or damage. Damaged Page 11 of 17

12 or unsuitable customer property is recorded and reported to the customer (per 7.2.3). ref - P-100 Inspection and Test Materials purchased from customers are not considered customer property and are controlled through normal purchasing and receiving processes (section 7.4) Preservation of product Documented procedures have been implemented and personnel have been trained so that identification, handling, storage, packaging, preservation, and shipment of product and product components are carried out in manner that will maintain conformity with product requirements. ref - P-150 Handling, Storage, Packaging, Preservation, and Delivery Special packaging requirements specified by the customer are listed or referenced in shipping documents (section 7.2). Products are not released for shipment until all required inspections and verifications have been completed and approved documentation is available (sections and 8.2.4). 7.6 Control of monitoring and measuring equipment To ensure that all inspections, measurements and tests for production are valid, inspection, measurement and test equipment is calibrated, verified, or both, at scheduled intervals per documented procedures. Records of all such calibrations and verifications are maintained and the equipment is protected from unauthorized adjustment. Re-calibrations and verifications are done based on manufacturers' recommendations, industry standards, and/or the history of the individual piece of equipment by qualified sub-contractors or qualified company personnel. Procedures include a decision making process to determine the necessity of the assessment of the validity of previous inspections/tests when inspection, measurement, and test equipment is found to be out of calibration. ref - P-110 Calibration System Inspection, measurement, and test equipment (calipers, rulers, measuring indicators/devices, tape measures, and scales) used in warehousing and distribution operations are controlled in the same manner as production inspection, measurement, and test equipment. ref - P-110 Calibration System Technical data pertaining to measuring and monitoring devices is made available when required by a customer. Determination of the measurements to be made, the accuracy requirements and selection (specify) of the appropriate measuring and monitoring devices that are capable of the necessary accuracy and precision is achieved through quality assurance personnel input to the product planning/realization process (section 7.1). 8 Measurement, analysis, and improvement Page 12 of 17

13 8.1 General HFI's plan for measurement, monitoring, analysis, and improvement processes are defined and implemented through documented procedures referenced in this section of the quality manual. The procedures contain descriptions of the type, frequency and records of the evaluation process. 8.2 Monitoring and measurement Customer satisfaction An integral part of the monitoring activities associated with quality system improvement is the requirement that the methods for the collection, analysis, and reporting of information on customer satisfaction (and/or dissatisfaction) be included in control procedures. Communication methods and frequencies for soliciting customer satisfaction data are procedurally defined. ref - P-030 Contract Review Customer satisfaction data and results are used as input to management review (section 5.6) Internal audit Trained internal auditors conduct documented assessments of the quality system in order to determine if it has been effectively implemented and is being maintained per policy. In addition, internal audits are used to identify process, organizational, infrastructure, and operational improvements as well as assessing and monitoring training effectiveness (per 6.2.2) and the understanding of the organization s quality policy and objectives (per 5.3 and 5.4.1). Audits are scheduled based on the status and importance of the activity/area being audited and the results of previous audits with each segment of the quality system are audited at least once every year. Procedures define the qualifications of internal auditors and the methods for scheduling and performing internal audits. Audits are conducted by personnel independent of those having direct responsibility for the activity being audited. ref - P-170 Internal Quality Audits Results of internal audits and potential process, organizational, or operational improvements identified during the audits are reported to Management Review (section 5.6). Verification of corrective actions associated with internal audit findings is done as part of the formal corrective action process (section 8.5.1) Internal auditing forms are structured to collect employee input on improvement opportunities (section 8.5) and identification of needed organizational skills (section 6.2) Monitoring and measurement of processes The quality management system is monitored on an ongoing basis through the process of internal audits (section 8.2.2). Verification of corrective actions associated with internal audit findings is accomplished through the systemic action process (section 8.5.1) Page 13 of 17

14 Statistical process control is used to ensure process effectiveness when specified by customer contract per procedures associated with product realization (section 7.5) Nonconformities in processes are subject to corrective action (section 8.5.2) Evaluation of production process takes place in conjunction with the quality planning and evaluation system and as part of the continuous improvement process associated with Management review ref - P-010 Management review ref - P-011 PQMC ref - P-020 Quality planning and evaluation Monitoring and measurement of product The company maintains documented procedures to ensure monitoring and measurement of product is carried out in a consistent and controlled manner in order to ensure customer requirements are met. Records of conformance with acceptance criteria are maintained for measurement and monitoring activities. Authority for the release of products, components, and raw materials are specified in control procedures. ref - P-100 Inspection and Testing The means of identifying the status of products or components relative to inspection, measurement and verification activities is described in the above procedures (per 7.5.3). Products are not released for shipment or delivery until all required inspections and verifications have been completed and approved documentation is available (section 7.5.1) 8.3 Control of non-conforming product The control and disposition process for non-conforming product is documented in quality procedures and is carried out in a manner that prevents its inadvertent use or shipment. Non-conforming product remains so identified until disposition has been completed. Where applicable, the disposition may be to reject, rework, or scrap. Reworked product is required to undergo re-inspection and/or re-test in accordance with the documented inspection requirements. ref - P-130 Control of Non-Conforming Product Nonconformities discovered after delivery to the customer may be accepted by the customer on concession, reworked/re-verified at the customer site, or returned for disposition. ref - P-030 Contract review 8.4 Analysis of data In an effort to continually improve the operation of the organization s quality management system, procedures have been established that describe the use of data and records associated with Quality System operations to facilitate the continuous improvement process and direct the activities associated with Page 14 of 17

15 collection, analysis, and reporting of applicable system data elements and records. These procedures also cover the collection of data from specific activities within the Quality Management System. This data includes, but is not limited to, process operation trends, customer satisfaction, conformance to customer requirements, characteristics of processes and products, and suppliers. ref - P-010 Management review ref - P-011 PQMC 8.5 Improvement Continual improvement Discussion and monitoring of continuous improvement plans are an integral part of management reviews (section 5.6) and quarterly quality review meetings. Actions necessary to implement those plans as well as organizational changes needed to improve system performance and actions necessary to address findings from internal audits (per 8.2.2) are directed via action requests during management reviews (section 5.6), quarterly quality reviews and/or weekly PQMC meetings. ref - P-010 Management review ref - P-011 PQMC ref - P-020 Quality planning and evaluation ref - P-140 Corrective and Preventive Action Employee input on improvement opportunities is collected during the internal auditing process (section 8.2) and reported to the PQMC Corrective and preventive action Corrective action takes place in conjunction with defined processes and procedures throughout the company's quality system. For repetitive discrepancies, major problems, declining performance in quality objective measurements, and systemic issues, the formal corrective and preventive action system is used. The formal system operates on 3 levels: 1 Corrective Action address the symptom and correct the error made. 2 Preventive Action change process to prevent this and similar problems from occurring in the future. 3 Systemic Action change documentation to institutionalize the improvement and ensure future employees are trained on the new, better methods. Verification that the action taken has been successful is carried out by qualified internal auditors and records of the entire process are maintained as evidence that the system is operating effectively. ref - P-140 Corrective and Preventive Action Management review includes the status of, and trends in, corrective and preventive actions (section 5.6) Preventive action See section Page 15 of 17

16 Overview Organization Chart APPENDIX I Note: This page is modified as necessary without revision level change to Quality Manual Page 16 of 17

17 Quality Manual Revision History: APPENDIX II Rev Date Description of Change(s) #0 08/23/99 Original Issue #1 10/22/99 Changed ref. P-091 #2 12/31/99 S-000 ref. Removed #3 09/13/02 Changed Binder Designation #4 11/01/02 Updated to ISO standards #5 02/09/10 Updated to ISO standards Page 17 of 17