ISO 9001:2008 QUALITY MANUAL. Revision B

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1 ISO 9001:2008 QUALITY MANUAL Revision B Because we want you to achieve the highest levels of performance, we connect care Because with leading we want science you to achieve continuously the highest improve, levels problem of performance, solve and create we connect the most care with leading science effective to cleaning continuously solutions improve, to suit problem your specific solve and needs. create the most effective cleaning solutions to suit your specific needs. KYZEN is an ISO 9001:2008 certified company. KYZEN is an ISO 9001:2008 certified company. KYZEN TECHNICAL REPORT Page 1 of 1

2 DOCUMENT APPROVAL Title: Kyzen Quality Manual Document No. Q Approval of this document verifies that it has been thoroughly reviewed and all required changes implemented. President: Date: 29-Aug-2014 Kyle J. Doyel Quality Systems Manager: Date: 29-Aug-2014 John M. Williamson, CSSBB Change Log Revision Affected Pages Description/Reason Issue Date A All Initial Release B All Continuous Improvement Changes Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Approvals

3 INTRODUCTION Kyzen Corporation s Quality Management System (QMS) meets the requirements of the International Standard ISO 9001:2008. Kyzen developed and implemented this QMS in order to document the company s best business practices, better satisfy the requirements and expectations of its customers, and improve the overall management of the company. Divided into eight sections that correlate to the Quality Management System sections of ISO 9001:2008, this manual describes the QMS and defines authorities, inter-relationships and tasks of the personnel responsible for performing within the system. This manual also provides procedures or references for all activities comprising the QMS, to ensure compliance to the necessary requirements of the standard. Kyzen uses this Quality Manual internally to guide our employees through the various requirements of the ISO standard and associated company-specific procedures that must be met and maintained to ensure customer satisfaction and continuous improvement. Kyzen releases this Quality Manual externally to (1) introduce our Quality Management System to our customers, distributors and other associates, (2) provide references to specific procedures and (3) to demonstrate that our QMS is properly maintained and focused on customer satisfaction and continuous improvement. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 1 of 15

4 1 SCOPE This manual describes the quality management system used by Kyzen Corporation ( Kyzen ), a Tennessee corporation with its principal place of business at 430 Harding Industrial Drive, Nashville, Tennessee, 37211, USA, with international operation facilities in Europe and Asia: Kyzen BvBA, Vliegplein 14B, 9990 Maldegem, Belgium Kyzen Sdn. Bhd., Plot 47, Hilir Sungai Keluang 2, Bayan Lepas, Penang, Malaysia Kyzen participates in the research, development, manufacture, sales and service of precision cleaning chemistries, processes and equipment for various electronics and industrial sectors worldwide. It is the intent of the Management Team ( MT ) to establish a system that drives consistency, customer satisfaction and continual improvement. Documentation to support the system has been created and will continue to be improved upon as we strive to meet customer and organizational needs. Kyzen s quality management system is designed in accordance with the requirements defined in ISO 9001: 2008 and the MT ensures effectiveness of the system and compliance to the standard. In some sections of this manual, the word includes is used to indicate that Kyzen will meet the intent of the applicable Shall from ISO 9001: REFERENCE 2.1 NORMATIVE The quality management system was established to meet the requirements of ISO 9001:2008 Quality Management Systems-Requirements, our customers and the organization. The quality manual and procedures retain a numbering scheme correlated directly to ISO 9001: REFERENCES Throughout this Quality Manual, the following standards, documents and/or charts are used or referenced: ISO 9001: 2008 Quality Management Systems-Requirements P-423 Control of Documents P-424 Control of Records P-622 Competence, Training & Awareness P-720 Customer-Related Processes P-741 Purchasing Process P-742 Purchasing Information P-760 Control of Monitoring and Measuring Equipment P-822 Internal Audit P-830 Control of Nonconforming Product P-852 Corrective and Preventive Action Appendix A Process Flow Appendix B Organization Chart Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 2 of 15

5 3 TERMS AND DEFINITIONS The following terms, definitions and abbreviations are used throughout this document: Organization: Kyzen Corporation Supplier: Kyzen Supplier MT Kyzen Management Team MR Kyzen Management Representative 4 QUALITY MANAGEMENT SYSTEM 4.1 INTRODUCTION The MT determines the processes needed for the quality management system as they apply to the organization. The sequence and interaction of the processes are determined, along with the criteria and methods to ensure operation and control are effective. The resources and information necessary to support operation and monitoring of processes are provided so that processes can be properly monitored, measured and where applicable, analyzed. Actions are implemented to achieve planned results and continual improvement of these processes. Processes are managed in accordance with the requirements of ISO 9001:2008. When Kyzen chooses to outsource any process that affects product conformity to requirements, Kyzen ensures control over such processes. Any process that is outsourced is controlled and the type and extent is identified within our quality management system. 4.2 DOCUMENTATION General The quality management system documentation includes statements of a quality policy and quality objectives, a quality manual, documented procedures, records required by ISO 9001: 2008 and any documents including records, determined by Kyzen to be necessary to ensure the effective planning, operation and control of our processes. The system is comprised of four levels of documentation: Level 1 Quality Management System Manual Level 2 Procedures Level 3 Work Instructions Level 4 Forms/Records Quality Manual The quality manual documents the scope of the quality management system, including justification for any exclusions, procedures established for the quality management system, and a description of the interaction between the processes of the quality management system through the reference to associated procedures or processes in Appendix A that lists procedures that apply to the process listed Control of Documents Quality management system documentation is controlled and records are maintained per section Control of Documents (P-424) is established to define the controls for: Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 3 of 15

6 Approving documents for adequacy prior to issue; Reviewing, updating and re-approving as necessary; Ensuring that changes and the 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 documents of external origin, determined by Kyzen to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled; and Preventing the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose Control of Records Records have been established to provide evidence of conformity to, and the effective operation of the quality management system. Control of Records (P-424) defines the controls needed for the identification, storage, protection, retrieval, retention and disposition of our records. Records are legible, readily identifiable and retrievable. 5 MANAGEMENT RESPONSIBILITY 5.1 MANAGEMENT COMMITMENT The MR is responsible for ensuring the communication of the quality management system s requirements throughout the organization. The MT is responsible for establishing and communicating the quality policy and quality objectives to the appropriate levels within the organization. The MT is responsible for communicating the importance of meeting customer, statutory and regulatory requirements to the appropriate levels within the organization. The MT conducts regularly scheduled reviews of the quality management system for the system s continued suitability, effectiveness, adequacy, and conformance to organizational, customer and ISO 9001:2008 requirements, ensuring that the organization is meeting its quality objectives per Section 5.6 of this manual. The MT is responsible for ensuring the availability of resources. 5.2 CUSTOMER FOCUS The MT is responsible for ensuring customer requirements are determined, communicated and fulfilled with the aim of enhancing customer satisfaction. Customer-Related Processes (P-720), Corrective and Preventive Action (P-852), Management Review and customer satisfaction records are the primary sources for this purpose. 5.3 QUALITY POLICY Our quality policy is appropriate to the purpose of Kyzen and has a commitment for meeting requirements and continuous improvement, provides a framework for establishing and reviewing quality objectives, is communicated and understood throughout the organization and is reviewed for continuing suitability. KYZEN QUALITY POLICY STATEMENT Kyzen Corporation manufactures high-quality products, exceeding customer expectations through on-time shipping, new product development and continuous improvement. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 4 of 15

7 5.4 PLANNING Quality Objectives The MT is responsible for establishing quality objectives for the appropriate levels within the organization and for ensuring that such objectives are measurable and consistent with our quality policy. Our quality objectives include, but are not limited to: Customer Satisfaction New Product Development On-Time Shipping Quality objectives are established and reviewed at, but not limited to, the following meetings: Management review meetings MT meetings Quality Management System Planning The MT is responsible for identifying, planning, allocating, and documenting those resources necessary to accomplish the requirements of ISO 9001:2008 and the quality objectives. The MT will ensure that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Quality planning is primarily done during management review per Section 5.6 of this manual and as necessary. 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION Responsibility and Authority Functions and their interrelations within the organization, including responsibilities, are defined throughout the quality management system documentation and on the organizational chart in Appendix B. Quality system training is provided to all employees. The MT appoints the Management Representative (MR): The MR, irrespective of other responsibilities, has responsibility and authority for ensuring that the processes needed for the quality management system are established, implemented and maintained. The Management Representative for Kyzen is the Global Operations Manager. The MT is responsible for the overall coordination of the quality manual. The MR is responsible for reporting to top management on the performance of the quality management system, including needs for improvement per Section 5.6 of this manual. The MR is responsible for promoting awareness of customer requirements throughout the organization Internal Communication The MT ensures that the appropriate communication processes are established within the organization. The MR is responsible for training the various levels of the organization on the processes of the quality management system. The MR is responsible for communicating audit results and management review outputs to the organization regarding the effectiveness of the processes of the quality management system. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 5 of 15

8 5.6 MANAGEMENT REVIEW General Statement A majority of the MT conducts annual reviews of the quality management system for the system s continued suitability, effectiveness, adequacy, and conformance, ensuring that the organization is meeting its quality objectives. This review includes opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records of reviews are maintained per P-424, Control of Records Review Input Review inputs include, but are not limited to: Quality policy and objectives The results of internal and external audits Customer satisfaction records Process and product performance Supplier quality results Corrective and preventive actions status and effectiveness of actions taken Training Follow-up on any issues from previous management reviews Forthcoming changes that could affect the quality management system Recommendations for improvement Review Output Review output includes any decisions and actions related to, but not limited to: Opportunities and the plans for improvement of the quality management system and its processes Improvement of product related to customer needs and expectations Necessary quality planning needed to support quality objectives Conclusions from the analysis of input data The identification of the required resources to support the above outputs 6 RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES The MT determines and facilitates the resource allocation to implement, maintain and continually improve the quality management system and enhance customer satisfaction. 6.2 HUMAN RESOURCES General Employees performing specific tasks, affecting conformity to product requirements are qualified based on education, training, skills and experience per P-622, Competence, Training and Awareness Competence, Training and Awareness The MT determines the necessary competence for employees performing work affecting conformity to product requirements. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 6 of 15

9 Where applicable, Kyzen provides training or other actions to achieve the necessary competence. The effectiveness of the training provided to employees is evaluated as deemed necessary, but no less than annually. The MT will ensure that employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. Employees may request additional training through appropriate channels. Training records are maintained per P424, Control of Records. 6.3 INFRASTRUCTURE The MT will identify, provide, and maintain infrastructure to ensure product conformity. Infrastructure includes, but is not limited to: Buildings, workspace and associated utilities Process equipment (both hardware and software) Support services (such as transportation, communication or information systems) 6.4 WORK ENVIRONMENT The MT will identify and manage the work environment needed to achieve product conformity. 7 PRODUCT REALIZATION 7.1 PLANNING OF PRODUCT REALIZATION Processes having a direct effect on product quality are identified, planned and executed under controlled conditions. The MT is responsible for the planning of product realization and may use the results of P-720, Customer- Related Processes, for planning of product realization. Planning of realization processes will determine the following: o Quality objectives and requirements for the product o The need to establish processes, documentation and provide resources specific to the product o Verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance o The records that are needed to provide evidence that the realization processes and resulting product fulfill requirements 7.2 CUSTOMER-RELATED PROCESSES Determination of Requirements Related to the Product Kyzen reviews all contracts and orders to determine whether the customer s requirements are adequately defined, documented and understood. Verification of the ability to meet the contract or order requirements is done before acceptance. P-720, Customer-Related Processes, defines the process used to determine customer requirements and review capability. This process includes, but is not limited to: Requirements specified by the customer, including the requirements for delivery and post-delivery activities, Requirements not stated by the customer but necessary for specified or intended use, where known, Statutory and regulatory requirements applicable to the product, Any additional requirements considered necessary by Kyzen Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 7 of 15

10 7.2.2 Review of Requirements Related to the Product Review of Product Requirements (e.g. Contract Review) applies to all products or services sold. Purchase orders, work instructions, specifications or drawings document and/or define customer requirements. Sales/Marketing has overall responsibility for identifying customer and internal requirements and reviewing these requirements prior to commitment to ensure that (1) product requirements are defined, (2) contract or order requirements differing from those previously expressed are resolved and (3) Kyzen has the ability to meet the defined requirements. Where the customer provides no documented statement of requirement, Kyzen confirms the customer requirements before acceptance. When product requirements are changed, Sales will ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements per P-720, Customer-Related Processes. The Review of Product Requirements and subsequent follow-up activities are records maintained per P- 424, Control of Records Customer Communication The MT and Sales/Marketing serve as the interface between Kyzen and our customers for the following: Product information Inquiries, contracts or order handling, including amendments Customer feedback, including complaints 7.3 DESIGN AND DEVELOPMENT Design and Development Planning Kyzen identifies and assigns responsibilities for achieving design milestones and controls the necessary organizational interfaces (where applicable). Design input and output criteria are documented and the criteria reviewed. Kyzen may design novel, proprietary products as well as modifications to establish products, in order to meet specific needs of customers or the marketplace. The Director of Research and Development (DR&D) is responsible for assigning design, development and planning activities. P-730, Design and Development, defines the design and development process. The DR&D is responsible for the coordination of the new product development interface with customers, purchasing, production and other personnel, as required. For any new product or product modification, the DR&D appoints a Project Manager and defines product requirements and design objectives. To meet these objectives, the project manager initiates Kyzen s new product protocol (see New Product Protocol Process Map) and notifies appropriate staff. The project manager or assigned personnel updates design and development plans and records as appropriate Design and Development Inputs Design input is provided as outlined in Customer Related Processes, P-720, or Design and Development, P-730. When customer requirements cannot be fulfilled, the appropriate sales manager will contact the customer to agree upon alternatives. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 8 of 15

11 Design input shall include: o Applicable statutory and regulatory requirements; o Applicable information derived from similar designs of previously released products; o Customer inputs from contract review activities, as appropriate; o Any other requirements essential for design and development. o Requirements that are complete, unambiguous and not in conflict with each other Design and Development Outputs The design and development process ensures that design outputs meet the design input requirements so that products perform reliably, efficiently and safely under specified operating conditions. Design output includes the final technical documentation, and the verification against the design and development inputs at various stages of the design process. This documentation includes, but is not limited to: o Applicable information for purchasing, production and service operations; o Acceptance criteria; o Product characteristics essential for its safe and proper use. Design output is reviewed and approved at predefined stages, as defined in the project plan (refer to Section below). Records of this review are maintained per P-424, Control of Records Design and Development Review At strategic points in the process, as defined in the project plan, design reviews are performed to monitor the design and development progress. These reviews evaluate output to ensure it meets the design input requirements, as well as Kyzen s ability to fulfill those requirements, identify potential problems, and propose follow-up actions. P-730, Design and Development, outlines the process for design and development review. The records of design and development review results and subsequent follow-up activities are maintained per P-424, Control of Records Design and Development Verification Design verification is performed at various stages of the design process. This verification ensures anticipated design stage outputs meet the design input requirements. The project manager is responsible for design testing to verify functional performance per Design and Development, P-730. Other forms of verification may be employed, such as: o Comparison to proven designs; o Alternative calculations; o Design stage document review. The project manager and any necessary personnel address all known conflicts before moving to the next stage of the design process. The records of Design and Development Verification results and subsequent follow-up actions are maintained per P-424, Control of Records. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 9 of 15

12 7.3.6 Design and Development Validation Design validation ensures the product will consistently perform per requirements under defined operating conditions. Design and development validation is performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Validation is performed per P-730, Design and Development. Whenever possible validation will be completed prior to delivery of the product. Where it is impractical to perform full validation prior to delivery, partial validation may be performed to the extent possible. The records of design and development validation results and subsequent follow-up actions are maintained per P-424, Control of Records Control of Design and Development Changes Design changes must be documented and approved per P-730, Design and Development. Design changes are reviewed by the project manager and approved by the DR&D prior to implementation per P-720, Design and Development. The review of design of development changes includes evaluation of the effect of the changes on constituent parts and product already delivered. Design changes to released products may be requested by employees or customers, but these changes must be documented and approved per P-730, Design and Development. The records of design and development changes results and subsequent follow-up actions are maintained per P-424, Control of Records. 7.4 PURCHASING Purchasing Process Purchasing personnel ensure specifications for purchased product are communicated per P-742, Purchasing Information. Purchasing personnel are responsible for making sure purchased product conforms to specified purchase requirements. Evaluation of Suppliers o Kyzen selects suppliers based on their abilities to meet requirements for suitability, quality, cost and/or delivery. The Approved Suppliers List, or Approved Vendors List, and Supplier Performance records are maintained per P-424, Control of Records. Supplier selection and control is dependent upon the effect of the purchased product on subsequent product realization or the final product. o Quality performance of suppliers is monitored and controlled per P-741, Purchasing Process. o Suppliers that exhibit substandard quality of products or services may be required to provide cause and corrective action response per P-852, Corrective and Preventive Action. o Unless contractually required, failure to provide required cause and corrective action responses could result in termination of business ties with said supplier o The records of evaluation of suppliers and subsequent follow-up actions are maintained per P- 424, Control of Records. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 10 of 15

13 7.4.2 Purchasing Information Purchasing documents contain a clear description of the product or services ordered, and are approved prior to release in accordance with P-742, Purchasing Information. Purchasing information describes the product to be purchased, including where appropriate: o Requirements for approval of product, procedures, processes and equipment o Requirements for qualification of personnel o Quality management system requirements Purchasing Personnel will ensure the adequacy of specified purchase requirements before their communication to the supplier Verification of Purchased Product Purchased product will be verified to ensure that it meets specified requirements per P-742, Purchasing Information, training and/or the appropriate work instructions. When purchased product requires verification at a supplier s premises, the organization will specify those arrangements in the purchasing documents in accordance with P-742, Purchasing Information. 7.5 PRODUCTION AND SERVICE PROVISION Control of Production and Service Provision Kyzen plans and carries out production under controlled conditions. The Operations Manager has overall responsibility for operations control and will ensure: o The availability of information that specifies the characteristics of the product o Where necessary, the availability of work instructions o The use and maintenance of suitable equipment for production o The availability and use of monitoring and measuring equipment o The implementation of monitoring and measurement o The implementation of product release and delivery The Operations Manager is responsible for ensuring assignment of properly trained and qualified employees to accomplish operations per P-622, Competence, Training and Awareness Validation of Processes for Production and Service Provision Excluded Identification and Traceability Product is identified throughout product realization. Kyzen identifies the product status with respect to monitoring and measurement requirements throughout product realization per the appropriate work instructions, training or P-830, Control of Nonconforming Product. Where traceability is a specified requirement, product will be traced per Kyzen requirements or the appropriate work instruction, and records maintained per P-424, Control of Records Customer Property Kyzen exercises care with customer property while it is under our control or being used by Kyzen Customer property is identified, verified, protected, and safeguarded for analysis and/or testing or other defined purposes. Lost, damaged, or unsuitable customer property is recorded and reported to the customer. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 11 of 15

14 7.5.5 Preservation of Product Kyzen preserves the product during internal processing in order to maintain conformity to requirements. As applicable, preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of the product. The MT is responsible for preservation of product under their control per the appropriate work instruction or training. 7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT Kyzen determines the monitoring and measurement techniques and related equipment needed to provide evidence of product conformity to established standards. Procedures are in place to ensure that monitoring and measurement activities are carried out in a manner consistent with established standards. Kyzen determines the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. Kyzen has established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. The organization controls, calibrates, and/or verifies equipment used to inspect and/or test products per P-760, Control of Monitoring and Measuring Equipment. The Operations Manager, Applications Lab Manager or Analytical Lab Manager (as appropriate) shall: o Ensure equipment operates per specification and provide accurate measuring results, which represent product and/or process performance o Validate any software used for measuring and monitoring of specified requirements prior to use o Establish procedures to control inspection, measuring and test equipment. They also define responsibility, adequacy of the calibration standards used, traceability, out-of-tolerance situations, and documentation procedures All measurement, inspection, and test equipment used to verify product quality shall be verified by one or more of the methods described in P-760, Control of Monitoring and Measuring Equipment, and will: o Be calibrated or verified or both at specific intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration is recorded o Be adjusted or re-adjusted as necessary o Be identified to enable the calibration status to be determined o Be safeguarded from adjustments that would invalidate the measurement result o Be protected from damage and deterioration during handling, maintenance and storage o Have the results of calibration recorded o Have the validity of previous measurement results re-assessed if equipment is found to be out of calibration, and maintain a record of the investigation. Calibration procedures are established and maintained for each type of inspection, measuring, and test equipment used that have an effect on final product quality. These procedures include frequencies and the specifics of calibration, preventive maintenance, and verification records During the review of new equipment, equipment selected for use will be capable of meeting accuracy requirements. Records for control of measuring and monitoring devices are maintained per P-424, Control of Records. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 12 of 15

15 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 GENERAL The MT holds primary responsibility for ensuring the identification, implementation, and planning of adequate measurement and monitoring of activities to assure conformity and achieve improvement to product requirements and the quality management system. The MT holds primary responsibility for using and defining those statistical techniques employed for establishing, controlling, and verifying process capability and product characteristics. Appropriate measurement, analysis and improvement activities or needed statistical techniques are identified and applied by the MT. 8.2 MONITORING AND MEASUREMENT Customer Satisfaction The MT is responsible for monitoring information relating to customer perception as to whether Kyzen has fulfilled customer requirements. This information is communicated to the organization to facilitate timely and effective implementation of customer needs. The methods used to gather this information may include, but are not limited to: o Customer feedback through personnel o Corrective Action requests o Customer surveys Customer satisfaction data is reviewed during management review per section 5.6 of this manual Internal Audit The MR is responsible for planning, documenting, and ensuring internal audits are performed to verify the compliance and effectiveness of the quality management system. Audits are planned taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. Internal audits are scheduled and conducted (criteria, scope frequency and methods) according to P-822, Internal Audit. The documented internal quality audit results are maintained by the MR and will be reviewed with the MT during management review. Personnel responsible for audited areas must respond to audit findings in a timely manner per P-822, Internal Audit and P-852, Corrective and Preventive Action. The follow-up activities on actions taken are performed per P-822, Internal Audit and P-852, Corrective and Preventive Action. Only trained employees independent of the activity being audited conduct the internal quality audits. Records of internal audit results are maintained per P-424, Control of Records Monitoring and Measurement of Processes The MT holds primary responsibility for ensuring the identification of adequate techniques for establishing, controlling, and verifying quality system processes. Processes are monitored through customer feedback, management review, corrective actions and internal audits as per section 5.6 of this manual and P-822, Internal Audit, P-830 Control of Nonconforming Product or P-852-Corrective and Preventive Action. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 13 of 15

16 When planned results are not achieved, correction and corrective action are taken, as appropriate, to ensure conformity of the product or process per P-852, Corrective and Preventive Action. Records for measurement and monitoring of processes are maintained per P-424, Control of Records Monitoring and Measurement of Product Kyzen monitors and measures the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements. The Quality Systems Manager holds primary responsibility for proper measurement and monitoring of product. Personnel are responsible for examining and verifying their own work for conformance to applicable specifications, standards and/or work instructions. Evidence of conformity to acceptance criteria is maintained as a record. Records indicate the person(s) authorizing release of product for delivery to the customer and may be represented by a digital signature Product release for shipment will not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by the President. All records covering inspections, tests and release authority are maintained per P-424, Control of Records. 8.3 CONTROL OF NON-CONFORMING PRODUCT Kyzen ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. P-830, Control of Nonconforming Product has been established to define the controls, related responsibilities and authorities for dealing with nonconforming product. The Quality Systems Manager is responsible for the review and disposition of nonconforming product as per P-830, Control of Nonconforming Product. Kyzen (as applicable) deals with nonconforming product in one or more of the following ways: o Taking action to eliminate the detected nonconformity, o Authorizing use, release or acceptance under concession by a relevant authority and, where applicable, by the customer, o Taking action to preclude its original intended use or application, o Return to Supplier. Kyzen takes action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. Reworked product is re-inspected per applicable work instructions and records maintained. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained per P-424, Control of Records. 8.4 ANALYSIS OF DATA Kyzen determines, collects and analyses appropriate data to demonstrate the suitability and effectiveness of our QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. This includes data generated as a result of our monitoring and measurement activities and from other sources listed below. Management review, tracking and review of quality objectives, and the following procedures document the primary sources of data that the MT reviews to evaluate the effectiveness of the QMS, improvement Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 14 of 15

17 progress, customer satisfaction, conformance to product requirements, characteristics and trends of processes and products, opportunities for preventive action, and suppliers: o P-741 Purchasing Process o P-822 Internal Audits o P-830 Control of Nonconforming Product o P-852 Corrective and Preventive Action Analysis of data is done during Management Review per section 5.6 of this manual, or as appropriate. 8.5 IMPROVEMENT Continual Improvement Opportunities for improvements are identified through a comprehensive analysis of the quality policy, objectives, audit results, analysis of data, corrective and preventive action and management review. The MT will define specific and measurable objectives that support the Quality Policy and the overall quality management system. Management Review is the primary time for the planning of continual improvement of the quality management system, but it may be done during other meetings and records will be maintained. Records for continual improvement are maintained per P-424, Control of Records Corrective Action Kyzen takes action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective Actions are appropriate to the effects of the nonconformities encountered. P-852, Corrective and Preventive Action has been established to define requirements for: o Reviewing nonconformities (including customer complaints), o Determining the causes of nonconformities, o Evaluating the need for action to ensure that nonconformities do not recur, o Determining and implementing action needed, o Recording of the results of action taken, o Reviewing the effectiveness of the corrective action Preventive Action Kyzen 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. P-852, Corrective and Preventive Action has been established to define requirements for: o Reviewing potential nonconformities and their causes, o Evaluating the need for action to prevent occurrence of nonconformities, o Determining and implementing action needed, o Recording of the results of action taken, o Reviewing the effectiveness of the corrective action. Preventive actions are reviewed for effectiveness during scheduled management reviews per section 5.6 of this manual. Records for preventive actions and their follow-up are maintained per P-424, Control of Records. Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Page 15 of 15

18 APPENDIX A: PROCESS FLOW Overall Process Flow DOCUMENT NOT CONTROLLED IF PRINTED Associated Documentation Management Customer Request, Market Need or Product Evolution Q-422, P-423, P-424, P-622, P852 Customer Order Do we make it? NO Design and Development of Product P-720, P-730 Product in inventory? NO Material in inventory? P-720, P-730, P-741, P-742, P830 YES YES Dispatch of materials for production Purchase of Materials for Production P-622, P-830 Product Realization (Manufacturing) P-423, P-424, P-622, P-730, P-741 Monitoring and Measuring of Process and Product P-622, P-741, P-760, P-822, P-830, P-852 Product Packaging, Labeling and Release to Shipping Carrier P-622, P-830 Customer Customer Feedback P-720, P-730, P-852 Q REV B COPYRIGHT 2014 KYZEN CORPORATION All Rights Reserved Appendix A

19 BOARD OF DIRECTORS PRESIDENT & CEO EXECUTIVE VICE PRESIDENT 1 CHIEF TECHNOLOGY OFFICER EXECUTIVE VICE PRESIDENT 2 CHIEF FINANCIAL OFFICER EXECUTIVE VICE PRESIDENT 3 GLOBAL OPERATIONS MANAGER DIRECTOR OF RESEARCH & DEVELOPMENT INSIDE SALES MANAGER QUALITY SYSTEMS MANAGER GLOBAL TECHNOLOGY MANAGER GLOBAL CORPORATE CONTROLLER INFORMATION TECHNOLOGY ADMINISTRATOR PRODUCT MANAGER SPECIALTY CONSULTANT NATIONAL SALES ELECTRONICS SALES LATIN AERICA INDUSTRIAL PRODUCTS MANAGER ASSISTANT OPERATIONS US SHIPPING MANAGER CUSTOMER SERVICE SPECIALIST 1 CUSTOMER SERVICE SPECIALIST 2 ANALYTICAL MANAGER/ EHS DOCUMENT CONTROLLER RESEARCH & DEVELOPMENT CHEMIST INSIDE SALES SPECIALIST 1 APPLICATIONS MANAGER, CHEMIST ANALYTICAL LABORATORY SPECIALIST ENGINEERING MANAGER PROCESS ENGINEER TECHNICAL EXPERT/ SALES SUPPORT ASSISTANT CONTROLLER US MARKETING SPECIALIST REGIONAL SALES NORTH EAST REGIONAL SALES MEXICO REGIONAL SALES NORTH CENTRAL US PRODUCTION TECHNICIAN 1 TRAFFIC SPECIALIST 1 RESEARCH & DEVELOPMENT SUPPORT CHEMIST APPLICATIONS TECHNICIAN 1 QUALITY CONTROL CHEMIST 1 APPLICATIONS ENGINEER ASSISTANT CONTROLLER EU REGIONAL SALES SOUTH REGIONAL SALES NORTHERN MEXICO REGIONAL SALES EASTERN MIDWEST US PRODUCTION TECHNICIAN 2 TRAFFIC SPECIALIST 2 APPLICATIONS TECHNICIAN 2 QUALITY CONTROL CHEMIST 2 EP&P SUPERVISOR ACCOUNTANT 1 REGIONAL SALES MIDWEST SHIPPING SPECIALIST EP&P TECHNICIAN ACCOUNTING ASSISTANT 1 REGIONAL SALES PACIFIC ACCOUNTING ASSISTANT 2 Q REV B COPYRIGHT 2014 KYZEN Corporation All Rights Reserved Appendix B

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