Quality Management System Manual

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1 SpecSys, Inc. recognizes its responsibility as a provider of quality products and services. To this end, SpecSys, Inc. has documented, implemented and maintains a System that complies with ISO This manual provides comprehensive evidence to all customers, suppliers and employees of what specific controls are implemented to ensure product and service quality. This manual will be revised, as necessary, to reflect the System currently in use. It is available on the SpecSys, Inc. server to all employees and supplied on an uncontrolled copy basis to customers and suppliers who request a copy. Approved: Dave Gelhar President Daniel Eggen Quality Director Page 1 of 21

2 1.0 Scope / Mission Statement The scope of this is to specifically meet the requirements of ISO 9001:2000 and to develop and improve the quality management system. 1.1 Mission Statement SpecSys, Inc. is a full service provider of project management, engineering, and manufacturing for fast track projects, systems, and products. 1.2 Exclusions and Clarifications SpecSys, Inc. has permissible exclusion from the Service provision requirements of ISO 9001:2000 clause & 7.5.2; however; the production provisions of these two clauses still apply. SpecSys, Inc. does not plan or schedule the servicing of any of its manufacturing services produced at its Granite Falls, Montevideo, or Redwood Falls facilities. 2.0 Quality Policy At SpecSys we will: Ensure customer satisfaction by providing quality project management, manufacturing, and engineering services that meet our client s project requirements by: *Providing a work environment and culture that promotes initiative, innovation, and teamwork. *Understanding, documenting, and communicating customer requirements. *Practice processes, which are defined, measurable, reviewed, and updated as needed. Vision Statement At SpecSys our commitment is to embrace those who respect, honor, and value relationships. 3. Core Competency Simplifying complexity, on-time and on-budget. 4. Core Value Do what it takes while attempting to meet the client s expectations. Page 2 of 21

3 4 System 4.1 General Requirements SpecSys, Inc. has established, implemented and maintains a documented quality system in accordance with the requirements of ISO9001:2000. The Director of Quality, in conjunction with top management, has been given the authority and responsibility to review, maintain and improve the quality system. This is accomplished by: 1. The continual review and updating of the processes which comprise the quality system. 2. The documentation of the processes and the identification of their inputs and outputs as well as their sequence and interaction in the various quality system documentation. 3. Assigning authority and responsibility and making available the resources and personnel necessary to maintain the quality system. 4. The ability to monitor, measure, analyze and review the quality management system processes, the identification and correction of process and operational deficiencies and providing the resources and methods necessary to continually improve the effectiveness of the quality system. Should a process be out sourced by SpecSys, Inc. which may affect product quality, SpecSys, Inc. shall retain control of the process and the process controls shall be documented in the System. This Quality Manual Purchasing SOP 4.01, SOP Documentation Requirements General SpecSys, Inc. maintains a documented System in sufficient detail to ensure effective and consistent operation of the quality system and includes the following types of documents: Quality Policy / Vision Statement. Standard Operating Procedures and Flow Charts. Work Instructions. Miscellaneous Documentation, such as forms, supplier and/or customer supplied documentation, drawings, etc. Records as required by the quality system and ISO9001:2000. This Quality Manual The Quality Policy Page 3 of 21

4 Quality System Procedures & Documentation Quality Manual SpecSys, Inc. has developed and maintains a quality manual that includes: The scope of the quality management system. A reference to the documented procedures established for the quality management system. A description of the interaction of the processes that comprise the quality management system. This Quality Manual Control of Documents SpecSys, Inc. has established and maintains documented procedures to ensure the control of all documents and data that relate to the requirements of the Quality Management System and the ISO standard. The control system provides for the identification, approval, distribution, modification and recall of controlled documents. Controlled documents are maintained on the SpecSys, Inc. server and/or in an environment that provides for minimal deterioration or damage and prevents their loss. Should documents of an external origin be used, they will be controlled by the location or person receiving them. Should they be distributed to multiple people or locations, a distribution list will be maintained. SOP 2.01, SOP Control of Records A documented procedure outlines the process for the identification, collection, indexing, filing, storage, maintenance and disposition of quality records. Quality records include both hard copy and electronic records. The Director of Quality has overall responsibility for the administration of quality records. However, individual records may be stored and maintained in identified functional areas. Quality records are to be legible and maintained in a manner that prevents damage, loss or deterioration. The actual records, storage location and their retention times are documented. SOP Management Responsibility 5.1 Management Commitment Page 4 of 21

5 The management of SpecSys, Inc. is committed to implementing and maintaining a documented System. This commitment includes ensuring that customer, regulatory and legal requirements are understood and appropriately addressed, that the Quality Policy is understood and implemented at all levels of the organization, that quality objectives and plans are established as necessary and that the responsibilities of all functions affecting quality are clearly defined. Management will make provisions for the necessary resources and personnel to maintain the system, including a management representative, who will ensure that the requirements of this manual are met. Management will review the Quality Management System annually to determine its effectiveness and drive improvement. Communication and training of employees on applicable customer, regulatory and legal requirements. SpecSys, Inc. Quality Policy Quality Objectives Management Review Meetings 5.2 Customer Focus The management of SpecSys, Inc. is committed to customer service and satisfaction. By the development, implementation and continual improvement of the Quality Management System, management has focused the organization on the importance of identifying and meeting customer requirements and the continuous improvement of customer satisfaction. SOP 1.01, SOP Quality Policy The management of SpecSys, Inc. has defined and documented the company s commitment to quality, meeting customer requirements, customer service and continuous improvement in the Quality Policy. During the regular management review of the quality system, the Quality Policy is reviewed for continuing suitability and that it is appropriate for the quality goals and objectives of SpecSys, Inc. Quality Policy SOP Planning Quality Objectives The Management of SpecSys, Inc. establishes annual key initiatives, which include quality objectives. The objectives are established by the Management Review Process and are communicated to all levels of the organization for use in establishing each function s and employees annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for Page 5 of 21

6 products and are consistent with the quality policy including the commitment to continuous improvement. SOP System Planning The Management of SpecSys, Inc. ensures that the resources needed to achieve the quality objectives are identified and planned. Quality Planning takes place at both the system and process level and is integrated into the quality system procedures. Provisions are made to develop, implement, and improve the quality system documentation and processes for an effective total quality system. SOP Responsibility, Authority and Communication Responsibility and Authority The Management of SpecSys, Inc. has defined and documented the responsibilities and authorities of all members of the organization. These are communicated primarily by the Quality System documentation. Other methods used to communicate the responsibilities and authorities are new employee orientation, job and quality training, meetings and annual reviews. Every Employee of SpecSys, Inc. is responsible for the quality of the product and/or service that they provide to both internal and external customers. Also, they have the responsibility and the authority to identify and initiate action to prevent the occurrence of any non-conformances related to the product or service they provide. Individual quality responsibilities are defined in job descriptions and applicable quality system documentation Management Representative The Director of Quality has been given responsibility and authority for ensuring that the requirements of the ISO standard are established, implemented and maintained, and for providing management with evaluations of the quality system and support in administering and coordinating the quality system and for ensuring that the importance of meeting internal and external customer requirements is communicated to all levels of the organization. This Quality Manual SOP 1.01, SOP Internal Communication The management of SpecSys, Inc. has the responsibility to communicate to all SpecSys, Inc. employees information on the Quality System, its policies and procedures, its effectiveness and on-going issues. This is accomplished primarily by the distribution of the various quality policies and procedures, the SpecSys, Inc. Page 6 of 21

7 server, posting of the various Quality Performance Measures and the Quality Management System training. Additional methods can include but are not limited to departmental and/or location meetings, publication of meeting minutes, the employee review process, quality postings, etc. 5.6 Management Review General Reviews of the quality system are conducted by SpecSys, Inc. management at planned intervals. SpecSys, Inc. management uses the inputs to the management review process to assess the effectiveness, adequacy and suitability of the quality system. Based upon the results of the review, opportunities for improvement and potential changes to the quality system will be identified and documented. The review also looks at the need to update the quality policy and quality objectives. The Director of Quality will have ultimate responsibility for scheduling and conducting the review. Records of any conclusions reached and actions taken will be documented and maintained. SOP Review Input Inputs to the Management Review Process shall take into account the needs of both internal and external customers and shall be sufficient to allow for evaluation of the Quality System effectiveness and applicability to the identified goals and objectives of SpecSys, Inc. The necessary inputs are information on: a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement SOP Review Output When the need for improvement activities and/or corrective action is identified during the Management Review Process, such activities will be documented, responsibilities assigned and reporting and follow-up requirements identified. The output from the management review shall include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes, Page 7 of 21

8 b) improvement of product related to customer requirements, and c) resource needs SOP Resource Management 6.1 Provision of Resources The management of SpecSys, Inc. ensures that resources are determined and provided to implement, maintain and to continually improve the effectiveness of the System with the goal of enhancing customer satisfaction by meeting defined customer requirements. SOP 1.01 Quality Objectives Customer Feedback 6.2 Human Resources General The competency of SpecSys, Inc. employees to do the job is based upon appropriate education, training, skills and experience. The competencies required are identified in the appropriate job description. Job Descriptions Performance Reviews Competence, Awareness and Training Selection and Qualification Job descriptions which outline the knowledge and experience required for each position are established, maintained and communicated to all employees. Human Resources has the responsibility to maintain the job descriptions for the company. Employees are selected on the basis of capability and experience, and/or potential capability to do the job if provided the required training. Records of employee qualifications are maintained by HR. Training and Development The training needs for SpecSys, Inc. personnel are identified and training is provided which covers orientation, job skills, general and technical knowledge, quality and company policies and procedures. The importance and relevance of the employee s activities toward quality objectives are discussed. The effectiveness of training is evaluated and documented. Personnel whose job function changes are provided the training necessary to complete their new assignment. Page 8 of 21

9 Optional training is offered, along with an education reimbursement program for individuals who seek job-related training outside of SpecSys, Inc. Human Resources is responsible to maintain training records. Applicable training, education and experience SOP Infrastructure To ensure product and service quality and that customer requirements are met, SpecSys, Inc. maintains safe and clean facilities and equipment. Buildings and their associated equipment are maintained on a regular basis. Equipment is suitable for the job being done and is regularly maintained. Regular cleaning of facilities Preventive Maintenance Programs 6.4 Work Environment A suitable work environment is ensured by proper maintenance of buildings and HVAC equipment and by regular cleaning of the building. Safety is stressed and unsafe conditions are identified and corrected when found. Items such as lighting, work place design, equipment type and systems are taken into account Regular cleaning of facilities Preventive Maintenance Programs Safety Committee 7 Product Realization 7.1 Planning of Product Realization SpecSys, Inc. plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system. As appropriate, SpecSys, Inc. will determine: a) Quality objectives and requirements for the product b) The need to establish processes, documents, and provide resources specific to the product c) Verification, validation, monitoring, inspection, and test activities specific to the product and the criteria for product acceptance d) The records necessary to prove that the realization process and resulting product fulfill requirements Page 9 of 21

10 7.2 Customer Related Processes Determination of Requirements Related to the Product Before customer orders are accepted, SpecSys, Inc. shall determine customer requirements including: Customer specified product requirements Availability, delivery and support requirements Product requirements other than customer specified that are necessary for intended/specified use obligations related to product, including regulatory and statutory requirements any additional requirements of the organization SOP 5.01, SOP Review of Requirements Related to the Product Each order received by SpecSys, Inc. is reviewed by sales to verify that the customer s requirements are adequately defined and documented, are well understood, and that the customer s order requirements, including delivery, can be met. The Sales personnel interact with the customer to resolve all differences before contract acceptance. Appropriate departments are consulted as necessary during the contract review. The record of the review will be the accepted order. Changes to orders will be controlled and reviewed in the same manner as the original order, and when necessary, the change will be communicated to the proper functions to ensure that the customer requirements are met. SOP Customer Communication While any employee of SpecSys, Inc. may have contact with the customer, the primary responsibility falls with Sales and Marketing. The customer communication process includes: Requests for product information Response to bids, quotes, sales orders and changes to these documents. Requests for returns. Customer feedback, including customer complaints. SOP 5.01, SOP 5.03 Page 10 of 21

11 7.3 Design and Development SpecSys, Inc. plans and controls the design and development of product, and manages the interfaces between different groups involved to ensure effective communication and clear assignment of responsibility, and determine: a) The design and development stages b) The review, verification, and validation that is appropriate to each design and development stage c) The responsibilities and authorities for design and development This is accomplished by Flow Chart ENG Design and Development Inputs Inputs relating to product requirements will be determined and records maintained. The inputs will be complete, unambiguous, and do not conflict with each other, including: a) Functional and performance requirements b) Applicable statutory and regulatory requirements c) Applicable information derived from previous similar designs d) Other requirements essential for design and development This is accomplished by Flow Chart ENG Design and development Outputs SpecSys, Inc. documents design and development outputs that provides verification against the design and development input and is approved prior to release. The design and development outputs: a) Meet the input requirements for design and development b) Provide appropriate information for purchasing, production and if required, clients service provisions c) Contain or reference product acceptance criteria d) Specify the characteristics of the product that are essential for its safe and proper use This is accomplished by Flow Chart ENG Design and Development Review SpecSys, Inc. will conduct design reviews with representatives of functions concerned with the design and development stages being reviewed. At suitable stages, systematic reviews of design and development will be conducted to: a) Evaluate the ability of the results of the design and development to fulfill the requirements b) Identify problems or potential problems and identify necessary actions Page 11 of 21

12 Records will be maintained. This is accomplished by Flow Chart ENG Design and Development Verification SpecSys, Inc. will verify that the design and development outputs have satisfied the design and development input requirements. Records of the results and any actions will be maintained. This is accomplished by Flow Chart ENG Design and Development Validation SpecSys, Inc. performs design and development validation to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application. Where applicable, validation, validation will be completed prior to the delivery or implementation of the product, and records or validation results will be maintained. This is accomplished by Flow Chart ENG Control of Design and Development Changes SpecSys, Inc. documents and controls design and development changes and maintains the necessary records. Changes are reviewed, verified and validated as appropriate, and approved for implementation. Changes include evaluation of the effect on constituent parts and delivered product. This is accomplished by Flow Chart ENG Purchasing Purchasing Process The selection, assessment, and quality performance monitoring of suppliers is the responsibility of Materials Department. When an evaluation of a supplier s quality system is required, it will be conducted jointly by Materials Department and Quality Assurance. A documented system has been established to ensure that products and services purchased for inventory and customer orders conform to specified requirements and are purchased from approved suppliers or suppliers required by customers. Suppliers not specified by customers are selected based on their ability to meet specified requirements and an electronic file is maintained for each acceptable supplier. The on-going control of suppliers is through the receiving verification process as outlined in section of this manual. Should supplier performance or customer complaints so indicate, further controls may be implemented. Supplier performance will be monitored, and information on supplier nonconformance will be communicated as required to individuals who select suppliers. Supplier performance and selection will be reviewed at least annually. Page 12 of 21

13 SOP 4.01, SOP 4.02, SOP 4.07, SOP Purchasing Information Purchase orders will be reviewed and controlled and will contain information which clearly describes the product or service being purchased and any special requirements for delivery. Changes to Purchase Orders will be documented, reviewed and controlled in the same manner as the original. SOP Verification of Purchased Product Inbound product from suppliers will be visually inspected upon receipt for physical damage and verification that the shipment contains the correct product and quantity. Discrepancies will be documented and the product will be held and segregated until dispositioned. No stock will be released until the required inspection has been completed and documented. In the event more detailed inspection is required, it will be documented in an inspection procedure. Dock-to-Stock shipments will be allowed based upon historical records of vendor performance and establishment of a lot received audit system. SOP Production and Service Provision Control of Production and Service Provision Processes within SpecSys are controlled by any or all of the following: the sales order, work order, documented procedures, work instructions, applicable standards, and employee training. The sales/work order defines the items needed and also lists any special requirements, such as marking, packaging and delivery. Various procedures and work instructions are documented to ensure process consistency and quality and they define the various requirements needed to complete a process or task in an acceptable manner. Internal Audits are performed on the processes to determine the potential effectiveness of the process and the results are used to identify opportunities for improvement. A suitable work environment is ensured by proper maintenance of buildings and HVAC equipment and by regular cleaning of the building. All equipment, including any needed monitoring and measuring devices, is suitable for the job being done and is regularly maintained. All processes are carried out by trained employees and where appropriate, processes and their parameters are controlled and monitored to ensure that specified requirements are met. Various workmanship requirements are defined in the quality system documentation. Page 13 of 21

14 7.5.2 Validation of Processes for Production and Service Provision This element if exempted because SpecSys, Inc. has no special processes that require validation Identification and Traceability At all times while product and material is under SpecSys, Inc., Inc. control, it will be identified to ensure proper control and use. Traceability is not a normal customer requirement. However, should it be a contractual requirement for a customer, a documented method of traceability agreeable to the customer will be provided. Specific customer marking requirements will be noted on the order and will be transferred to the item or container as required. The acceptability of incoming product is documented on the receiving documentation by the individual performing the receiving operation. Acceptable material is moved to a staging area to be put into stock, while non-acceptable material is identified and held until dispositioned. Customer orders will be processed per documented procedures and inspection and test results will be recorded on appropriate paperwork. This will ensure that orders which are approved will be shipped and orders with discrepancies will be held until the discrepancies are resolved. Any employee may hold a nonconforming order, while the responsibility for release of orders is defined in the quality system documentation. SOP Customer Property The organization exercises care with customer property while it is under the organizations control or being used by the organization. The organization identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product. If customer property would become damaged or lost or otherwise found to be unsuitable for use, it s reported to the customer and records maintained (see4.2.4). Note: Customer property can include intellectual property Preservation of Product General Policy All parts and material, will be handled, stored and shipped in a manner that prevents damage and deterioration. The receipt and shipment of material to and from the warehouse will be controlled. Handling Material will be transported and handled in a manner to prevent damage and deterioration of the product quality. Material will be moved, identified, and staged in a manner to keep items segregated. Material will be stored on racks, pallets, in original Page 14 of 21

15 delivery containers, or other means to prevent damage and deterioration. When required, special handling instructions will be included on the sales order. Warehousing and Preservation Designated storage areas will be used, and storage conditions will be maintained to ensure material integrity. Storage conditions will be in conformance with environmental and shelf-life requirements when specified. Stored goods are reviewed on a continual basis during stock put-away and order picking to ensure its quality and condition. Stored goods found to be damaged or in a deteriorated condition will be identified and processed as nonconforming material. The requirements of this section shall apply to constituent parts of product as well. In the event that any special storage, segregation, or preservation techniques are required for specific material, procedures will be developed to ensure the requirements are met. Packaging Packaging of material is accomplished by providing boxes, cartons, plastic wrap, pallets and containers designed to provide protection and damage free delivery of the material. Delivery Customer orders will be packaged, labeled, and prepared to ensure material integrity during shipment and delivery. Shipping conditions will be in conformance with environmental and shelf-life requirements when specified. Delivery is accomplished by SpecSys, Inc or by a freight forwarder appearing on the Approved Carrier List. S0P Control and Monitoring and Measuring Devices The SpecSys, Inc. calibration program and supporting documentation ensures that: Equipment selected for use has the necessary accuracy for the measurement to be performed and that the equipment usage is controlled to ensure that the measurement uncertainty is known and that it is consistent with equipment capability. Equipment is identified and calibrated/adjusted at specified intervals and the calibration status is readily known. The calibration is traceable to a nationally recognized standard. Where no such standard exists, the basis used for calibration is documented. Documented calibration procedures are used which identify the equipment type, frequency, calibration method, acceptance criteria and the action to be taken when an out-of-calibration condition is found. Page 15 of 21

16 Calibration records are maintained, including action taken when equipment is found to be out of calibration. This would include the impact on previously performed operations. When appropriate, safeguards are taken to avoid unauthorized adjustments or tampering. Suitable calibration environment and facilities are provided and that the handling, storage and preservation of the equipment is adequate to ensure its continued accuracy. Test hardware or software, when used for acceptance, are subject to calibration control. Suppliers of calibration services are reviewed and approved prior to their use. The location or assigned responsibility for all inspection, measuring and test equipment is documented. Calibration records will be maintained. SOP Measurement, Analysis and Improvement 8.1 General SpecSys, Inc. has planned and implemented the measurement, monitoring and improvement processes needed to: Demonstrate conformity of product; Ensure conformity of the System; Continually improve the effectiveness of the System. This shall include determination of applicable methods, including statistical techniques, and the extent of their use. SOP 1.01, SOP 8.02, SOP 8.03, Flow Charts QA-08, QA-09, QA Monitoring and Measurement Customer Satisfaction Customer satisfaction, dissatisfaction and perception will be monitored and measured. This will be accomplished by various ways including but not limited to customer surveys, customer complaints, customer retention figures, market share and delivery measures. This information will be gathered by various departments and will be reviewed and made available to all SpecSys employee s through charts, meetings, announcements and the server and any other way that can communicate the level of satisfaction or dissatisfaction of a customer. SOP 1.01, SOP 5.03 Page 16 of 21

17 Customer Contacts-Companies and Regions Internal Audit Comprehensive, planned and documented quality audits are conducted according to a published schedule maintained by the Director of Quality. The frequency of each audit is dependant on the importance of the activity being audited and past audit results. The audits will be conducted by trained auditors having no direct responsibility for the area being audited. Records of auditor qualifications will be maintained. The purpose of the audits will be to verify the implementation of the quality system and supporting procedures, and to ensure it's continued compliance to the ISO standard. The audit results will be documented and reported to the appropriate managers and personnel. Nonconforming conditions will be reviewed and if necessary, corrective actions will be initiated. It shall be the responsibility of the manager of the audited area to inform all personnel in the area of the audit results. Follow-up activities will be done to verify the implementation and effectiveness of the corrective action. The Director of Quality will report as to the status of the internal audit system during the management review. Internal quality system audit records, including any corrective action activities to address audit deficiencies will be maintained as a quality record. The retention period for audit records is defined in the quality records procedure. SOP Monitoring and Measurement of Processes Monitoring and measurement of processes will take place a various levels within SpecSys, Inc. This can occur during management review, internal audits, as a result of customer complaints, non-conforming product among others. Management will monitor and review the quality objectives and determine if corrective actions need to take place Monitoring and Measurement of Product Product will be identified, controlled and inspected at receiving, while in stock and during picking and shipping to ensure that product requirements are met. These requirements have been previously described in the appropriate sections of this manual and the quality system documentation. Records of these activities are maintained either electronically or on paper and records are signed or initialed by the people who are authorized to release the product. Product shall not be released until all requirements have been met unless approved by the customer and/or user. Statistical techniques are not used in the normal daily operation of SpecSys, Inc., However, should it be deemed necessary to utilize statistical techniques, their application will be documented and those utilizing statistical techniques will be trained in their use and the statistical data will be maintained as a quality record. Page 17 of 21

18 8.3 Control of Nonconforming Product Nonconforming product is identified, segregated (when practical), and dispositioned to prevent unintended use or shipment. All non-conforming product is strictly controlled. Nonconformances are documented and analyzed to determine necessary corrective action. The responsibility, disposition options and authority for the disposition of nonconforming product is documented and records of dispositions maintained. If the disposition will have a negative impact on customer service, the affected parties will be notified. When nonconforming product is detected after delivery or use has started, the company shall take appropriate action to minimize the effects, or potential effects, of the nonconformity. Flow Charts QA-08 & QA Analysis of Data SpecSys shall determine the suitability and effectiveness of the quality management system and identify continual improvement opportunities that can be made by collecting and analyzing appropriate data to provide information on: customer satisfaction conformance to product requirements characteristics and trends of processes and products including opportunities for preventive action. Analysis shall include data from results of monitoring and measurement and from other relevant sources. SOP Improvement Continual Improvement Management will review the effectiveness of the quality system and determine what improvements can be made. Information used to make improvement decisions can be (but not limited to) audit findings, customer complaints, internal measures, employee input and market trends. This analysis will take place during Management Review and will be documented in the meeting minutes. SOP 1.01 Page 18 of 21

19 8.5.2 Corrective Action General Policy The organization takes action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered. A documented procedure is established to define requirements for: a) Reviewing nonconformities (including customer complaints) b) Determining the causes of nonconformities, c) Evaluating the need for action to ensure that nonconformities do not recur, d) Determining and implementing action needed, e) Records of the results of action taken(see 4.2.4) and f) Reviewing corrective action taken. SOP 8.02, SOP 8.03 and Flow Chart QA-10 Returned Material The process for the handling, identification, and disposition of returned material will be documented to ensure that only material that conforms to requirements is placed back into stock. Records of the return and reason for the return will be maintained and analyzed for chronic problems at least annually. The results of the analysis will be used to initiate corrective action, improve quality, and increase customer satisfaction. This is accomplished by Flow Chart QA-09 Quality System For quality system deficiencies identified outside of the internal audit system, the Director or Quality shall be notified and will be responsible for coordination of corrective action. This is accomplished by Flow Chart QA Preventive Action The organization determines actions to eliminate the cause of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. A documented procedure is established to define requirements for: a) Determining potential nonconformities and their causes, b) Evaluating the need for action to prevent occurrence of nonconformities, c) Determining and implementing action needed, d) Records of results of action taken (see 4.2.4), and e) Reviewing preventive action taken. Page 19 of 21

20 SOP 8.02 and Flow Chart QA-10 Interaction between System Processes Page 20 of 21

21 Appendix A-Organizational Chart REVISION HISTORY Issue Date Changes 6/16/06 Approval 3/15/07 Revised and updated. PCO 4/9/07 Rev B PCO 4/16/07 Rev C PCO 4/20/07 Rev D Updated sections & PCO 5/11/07 Rev E Corrected Fonts/Typos PCO 6/26/07 Rev F Added Organizational Chart PCO 7/11/07 Rev G-Defined review input and output & records PCO Page 21 of 21

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