Quality Manual QM-9001
Rapport, Inc. dba Car-Go Battery Co. 13180 West 43rd Drive Wheat Ridge, Co 80403-7232 Phone: (303)-202-9599 Fax: (303)-202-9596 www.rapportinc.com Quality Manual QM-9001 Revision #10 September 2013 Submitted by: Thomas Derryberry, General Manager Approved by: Dale Lehman, Vice President Page 1 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. Rapport, Inc. Quality Manual 1.0 2.0 3.0 4.0 General Purpose / Scope………………………………………………… Normative references……………………………………………………… Terms and Definitions……………………………………………………… Quality Management System………………….…………………………… 4.1 General requirements 4.2 Documentation requirements 5.0 Management Responsibility……………………………………………….. 5.1 Management Commitment…………………………………………… 5.2 Customer Focus……………………………………………………… 5.3 Quality Policy………………………………………………………… 5.4 Planning………………………………………………………………. 5.5 Responsibility, Authority and Communication………………………. 5.6 Management Review…………………………………………………. 6.0 Resource Management……………………………………………………… 6.1 Provision of Resources……………………………………………….. 6.2 Human Resources……………………………………………………. 6.3 Infrastructure…………………………………………………………. 6.4 Work environment…………………………………………………… 7.0 Product Realization………………………………………………………… 7.1 Planning of Product Realization……………………………………… 7.2 Customer Related Process……………………………………………. 7.3 Design and Development…………………………………………….. 7.4 Purchasing……………………………………………………………. 7.5 Product and Service provision……………………………………….. 7.6 Control of Monitoring and Measuring Devices……………………… 8.0 Measurement, Analysis and Improvement……………………………….. 8.1 General………………………………………………………………. 8.2 Monitoring and measurement……………………………………….. 8.3 Control of Nonconforming Product…………………………………… 8.4 Analysis of Data……………………………………………………… 8.5 Improvement 9.0 Procedure and Records Matrix……………………………………………. 10.0 Authorization………………………………………………….…………….. 11.0 Revision History……………………………………………….……………. Page 2 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 1.0 QMS Purpose / Scope and Exclusions: This quality manual documents the Quality System, quality policy, and quality objectives implemented at Rapport, Inc dba Car-Go Battery Co. located in Wheat Ridge, Colorado. General company information may be obtained at Rapport Inc. website: www.rapportinc.com. This manual provides specific policies and procedures to ensure customer satisfaction in our products and services with continuous improvement built in. The scope of ISO registration applies to the manufacture, marketing, sales, purchasing, shipping and receiving of interconnecting cables, wire harness, wire assemblies, electro-mechanical assemblies, batteries and custom battery assemblies. It is essential that we provide the highest quality products and service in order to earn and maintain the confidence of our customers. The Vice President of Rapport, Inc approves this quality manual. This manual and all supporting documents support the ISO 9001 International Quality Standard, ANSI/ASQC 9001-2008 with two exclusions: 7.3. (Design and Development) and 7.5.2 (Validation Of process for production and service provision). 2.0 Normative References: • N/A. 3.0 Terms and Definitions: • Documented Procedure – Is a written document used to define a process. • Management Review – Is a regular systematic evaluation of the suitability, adequacy, effectiveness and efficiency of the quality management system. • Management Team – Is a team of supervisors, managers and the General Manager representing each department within Rapport Inc. dba Car-Go Battery Co. • Process – Is a set of interrelated or interacting activities that transforms inputs into outputs. • Product – Is the result of a set of interrelated or interacting activities, which transforms inputs into outputs. • Product Realization – Is a set of interacting processes designed to produce a product or service and fulfill the customer’s requirements. • Top Management – Is a person or group of people who lead the organization at the General Manger level or above. • Rapport Inc. – Rapport Inc. dba Car-Go Battery Co as of March 21, 2012. Page 3 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 4.0 Quality Management System: 4.1 General Requirements: Rapport Inc. documents, implements and maintains a quality management system that continually monitors and provides continuous improvement in accordance with the requirements of the ISO 9001 International Standard. The Quality Management System is evaluated via internal audits, external customer audits, customer surveys, customer scorecards, management reviews, and through daily use. These practices ensure: • The processes for the quality management system are identified and implemented throughout the organization. This includes but not limited to, processes for management activities, provision of resources, product realization and measurement. • The sequence and interaction of processes is determined and documented on process maps and flowcharts. • Methods and criteria for control of processes have been determined and identified to ensure effectiveness. • Resources and information necessary to support the implementation and monitoring of processes are available. • Quality management system processes are monitored, measured, and analyzed at prescribed intervals to meet the business needs of the company, along with all customer requirements. • Necessary actions are taken to achieve planned results, and continual improvement processes. • Methods of control over out-sourced processes that affect product conformity with requirements are established. 4.2 4.2.1 Documentation: General statement: Rapport, Inc. maintains and implements a documented Quality management System that includes: • A quality policy statement and objectives are documented in this manual and also published and distributed throughout the organization in both hard copy and electronic formats. • The quality manual is reviewed by the Management Team and approved by the Vice President of Rapport, Inc. • Rapport, Inc. quality system is documented in four levels: a) Tier 1: Quality Manual & Company Info b) Tier 2: Procedures and Plans c) Tier 3: Work Instructions d) Tier 4: Quality Records Page 4 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. • The level of documentation to support the quality system is based on skills, methods, and training required by the personnel responsible for the performed work. It is the responsibility of the General Manager to provide revision control and organization of the master and controlled copies of all Tiers 1, 2, and 3 quality system documents. Controlled records (level 4) are maintained and controlled as required. 4.2.2 Quality Manual: The Quality Manual represents the quality system utilized in the daily operations at Rapport Inc. The quality manual includes: • The scope of the quality management system, including details of any justification for exclusions. • The documented procedures established for the quality system, or reference to them. • The description of the interaction between the processes of the quality management system. See Rapport Inc. QMS Map. 4.2.3 Control of Documents: • All documents required by the quality management system will be controlled according to the requirements given in 4.2.3 and defined in Rapport, Inc. Control of Documents procedure. • All documents are approved for adequacy by a designated authority prior to use. • Any redlines to controlled documents must be dated and initialed. • All documents are revision-controlled, by either a specific revision number or a date. • Relevant versions of applicable documents are available to those who require them. • All documents are legible and identified with a document name document number and / or version number. • Documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and have their distribution controlled. • Obsolete quality system documents are removed from the quality system master file and suitable identification is applied if the company retains them for any purpose. 4.24 Control of Records: • Records are established and controlled to provide evidence of conformity to requirements and of the effective operation of the quality management system. • All records required by the quality management system will be controlled according to the requirements given in 4.2.4 and defined in Rapport, Inc. Control of Records procedure. • Rapport, Inc. has a documented procedure to define the controls needed for identification, storage, protection, retrieval, retention and disposition of records. • All records are legible, readily identifiable and retrievable. • Records are in the form of electronic or hard copy. • All ISO required records are tracked on a Records Retention Matrix located on the “G” drive (Tier 2). Page 5 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 5.0 Management Responsibility: 5.1 Management Commitment: Rapport, Inc. management is committed to the development and implementation of the quality management system, and continually improving its effectiveness. Management commitment is demonstrated by the following ways: • Communicating to the organization the importance of meeting customer requirements, plus all statutory and regulatory requirements. • Establishing a quality policy and ensuring that it is communicated and understood throughout the organization. • Establishing quality objectives and reviewing them. • Conduct management reviews. • Conduct internal audits. • Ensuring availability of resources as required to achieve the business needs of the company. 5.2 Customer Focus: Rapport, Inc. manufactures and markets cables, wire harnesses, batteries, custom battery assemblies, and electromechanical subassemblies for a wide range of industrial applications. Rapport, Inc. continually monitors the market and customer demands to ensure that quality solutions are produced for existing and potential customers. We create and review customer quotations, along with identifying and improving customer satisfaction. 5.3 Quality Policy: Rapport, Inc. quality policy is to provide our customers with products and services that perform to their specifications, delivered on time, at a competitive price, and to continually review and improve the quality management system, thereby insuring stability and future growth for the company and its associates. Rapport, Inc. management ensures that: • Our quality policy is appropriate to the purpose of the organization. • We are committed to comply with the requirements of our customers and the quality management system, and to continually improve the effectiveness of the quality management system. • Provide a framework for establishing and reviewing quality objectives. • We communicate the quality policy and ensure that it s understood throughout the organization. • Our quality policy is reviewed annually at a minimum for continuing suitability. . Page 6 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 5.4 Planning; 5.4.1 Quality Objectives: Top management ensures that the quality objectives are established for the relevant functions and at the correct level within the company. All quality objectives are measurable and consistent with the quality policy. Rapport Inc.’s quality objectives are: * Deliver product within the requirements of the expected delivery date 98% of the time, excluding any special arrangements with our top 3 battery customers and our top 3 cable harness customers. * Commitment to the continual improvement of the Quality Management System * Improve Customer satisfaction year-over-year. * Enable and encourage employees to strive for excellence in their work. 5.4.2 Quality management system planning: We have various types of quality planning at Rapport, Inc. (1) Product Planning, (2) Project Planning and (3) Setting Quality Objectives. All three types of planning are implemented to meet the requirements in clause 4.1, as well as the quality objectives established by Rapport, Inc. Product Planning is in response to an identified market or customer need. The customers design process controls the development process for new products. The procedure is used to identify customer requirements and to ensure internal capability to meet those requirements. Project Planning is a process where opportunities for improvement or problems are identified and a plan is developed accordingly. These plans address preventive measures involving the quality process or service improvement. Projects are initiated as the result of input from any and all employees and may come from, but are not limited to, areas such as performance goals, department targets, and plans because of strategic planning. Projects are assigned to individuals or groups by management. These individuals or groups are then responsible for the development and execution of the project plan. Management ensures the integrity of Rapport, Inc’s quality management system is maintained when changes to the system are planned and implemented. The methods of implementing change at Rapport, Inc: 1. Organization plans, objectives, and goals derived from the company business plan. 2. Preventive/Corrective Actions. 3. Engineering Change Orders (ECO's). 4. Approved customer requirements. Based on the business plan, departments work with management to develop project plans. Project plans contain measurable objectives, and/or specific targets. Page 7 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. The formal input and feedback instruments for the Quality System are explained in our Corrective / Preventive action procedures. This provides the mechanisms for routing to the correct department, verification and effectiveness of solutions, and any additional controls needed. Corrective and preventive actions are tracked from initiation to closure. The way to make changes to product, or processes, is through the ECO process and through the Preventive Action process. 5.5 Responsibility, Authority and Communication: Responsibility and Authority: Top management ensures that responsibilities and authorities are established and communicated throughout the organization: • Job descriptions/job category descriptors list the responsibilities, competencies and authorities necessary for employees to effectively carry out the requirements of their jobs. • Employees have the responsibility and authority to identify, document, and report any nonconformance’s relating to the quality management system. • All employees have the responsibility to identify, document and implement improvements and preventive action within their process. 5.5.1 Management Representative: A management representative is appointed by Rapport, Inc. to coordinate, manage, monitor and evaluate the quality management system as well as serve as liaison regarding quality issues. The management representative has the responsibility and authority to: • Ensure that all processes needed for the quality management system are established, implemented and maintained. • Report to top management on the performance of the quality management system, including any need for improvement. • Ensure the promotion of awareness of customer requirements throughout the organization. 5.5.2 Internal Communication: Top management ensures that effective communication processes are established throughout the organization with regard to the quality management system. • Company status meetings are conducted once a year at a minimum to review the status of key quality objectives with all employees. • Departmental meetings are held as required to review the status of tactical goals. • Management meetings are held as required to monitor and evaluate quality related data such as corrective / preventive actions, customer satisfaction, and manufacturing yields. Page 8 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. • • 5.6 Performance appraisals are conducted as required with individual employees to review and evaluate progress toward achieving individual goals. Lines of communication are cross -functional and open at Rapport, Inc. Communication between and within departments may occur via email, open discussions, and management reviews. Management Review: 5.6.1 General: A formal review of the quality management system is conducted a minimum of once per year, scheduled by the quality management representative. During this review, the quality management system is reviewed to ensure its effectiveness, adequacy and continuing suitability along with assessing opportunities for improvements. Records from these reviews are maintained per ISO 4.2.4. In addition, quality data is monitored and evaluated to meet the business needs of Rapport, Inc. 5.6.2 Review Input: At a minimum, the following information is reviewed during the management review: • Results of all internal audits. • Customer feedback / satisfaction. • Performance to quality objectives. • Preventive and corrective action data. • Follow-up actions from previous management reviews to ensure that they were implemented effectively and on time. • Changes that could affect the quality management system. • Recommendations for improvement. 5.6.3 Review Output: Minutes from management review meetings are documented and included any decisions and actions related to: • Improvement to the effectiveness of the quality management system and its processes. • Product improvements, in relation to customer requirements. • Resources needed to meet the business needs of the company. All action items assigned as a result of management reviews are documented and tracked until completion. 6.0 Resource Management: 6.1 Provision of Resources: Resources are determined and provided that they are necessary to: • Implement and maintain the quality management system, and continually improve its effectiveness. • Ensure that customer requirements are met with the intent of enhancing customer satisfaction. Page 9 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 6.2 Human Resources: 6.2.1 General: Our hiring process is established to ensure that all personnel are competent based on their education, training, skills and experience. Job descriptions help in defining the required experience, training skills and amount of supervision necessary to perform the tasks. 6.2.2 Competence, Awareness and Training: Rapport Inc. ensures that: a) All personnel are competent based on the requirements set for their job description to conform to product requirements. • In addition to skills and experience, core-training needs are determined for each employee upon hire and documented within the training matrix. • Additional training needs may be determined for each employee during the performance appraisal process and documented on the appraisal form. Training needs may also be determined as part of the internal audit process. b) All necessary training or certifications are provided. Other actions are taken to satisfy competency needs that meet the business needs of the company. c) The effectiveness of training is evaluated during the performance appraisal process and as part of the internal audit process. d) Records of appropriate education, skills, experience and training for each employee is maintained. 6.3 Infrastructure: The management team determines, provides and maintains the infrastructure necessary to achieve conformity to product requirements. This includes: • Providing workspace and associated utilities to meet the business needs of the company. • Provisions of suitable equipment, tools and software for manufacturing, inventory, finance, and administrative processes. Maintenance of the manufacturing equipment is performed per the manufacturer’s specifications or customer requirements to ensure equipment is capable of achieving conformity of processes and product. • Supporting services such as shipping or transport, internet service, document disposal and building security. • Resources needed to maintain the infrastructure. 6.4 Work Environment: Adequate facilities and programs are maintained to provide the infrastructure needed to achieve conformity to product requirements. This infrastructure includes but is not limited to: • Clean, safe workstations/work areas with adequate lighting to ensure the health and efficiency of our employees. Page 10 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. • • Adequate facilities that includes a lunch/break room, restrooms, outside picnic/break area and a first aid station. Employee programs such as 401(K) retirement plan, luncheons, and special events, to motivate and involve employees through social interaction. 7.0 Product Realization: 7.1 Planning of Product Realization: Rapport Inc. plans and develops the processes needed for product development and product realization. Planning of product development and product realization is consistent with the process requirements of the quality management system (4.1), including: • Reviewing quality objectives for the product. • Establishing processes, reference documents and resources that are specific to the product. • Ensuring verification, validation, monitoring, measurement, inspection and test activities specific to the product take place, and criteria for product acceptance are provided. • Ensuring records are generated to provide evidence that the realization processes and resulting product meet requirements. 7.2 Customer-Related Processes: 7.2.1 Determination of Requirements as related to the Product: Rapport Inc. determines: • The customer-specified requirements for delivery schedules before us accepting orders for product. • The requirements not stated by the customer, but required for intended use. These requirements, usually technical in nature, are determined at the initial stages of development is documented for each product and sent back to the customer for clarification of customer requirements. • The statutory and regulatory requirements to the product are documented. • Any additional requirements that are considered necessary by the company. 7.2.2 Review of Requirements related to the Product: Prior to Rapport’s commitment to supply product to a customer, a review process takes place for both standard catalog products and nonstandard products. The review takes place to ensure: • Product requirements are adequately defined, including availability, price and shipment details. • All sales order conflicts or action items are resolved. • The capability to meet shipping dates, product requirements and any other defined requirements. Records of the results of the reviews and any actions taken from reviews are maintained in accordance with ISO 4.2.4. A written confirmation is required between Rapport, Inc. and the customer before us processing the order. Page 11 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. When product requirements are changed using the ECO Process, Rapport, Inc. ensures that customer relevant documents are amended, and that all relevant personnel are made aware of the amended requirements. 7.2.3 Customer Communication: Effective communication with customers is established regarding product information, orders, complaints and feedback. In addition, normal responsibilities for communication with customers are assigned as follows but can be changed to meet the business needs of the company: • Sales are responsible for communication with existing and potential customers regarding products, technical specification, and applications assistance and determining initial customer requirements. • Customer Service is responsible for communication with the customer regarding pricing and delivery inquiries, orders and contracts, order amendments and shipment issues. • Management, Operations, Quality Assurance, Customer Service, and Sales, are responsible for communications with the customer regarding customer returns, complaints, customer feedback and satisfaction. 7.3 Design and Development: This section does not apply to Rapport, Inc. 7.4 Purchasing: 7.4.1 Purchasing Process: We maintain suppliers retained based on their ability to conform to specific customer and purchasing requirements. The extent of controls applied to suppliers and purchased products is dependent upon the effect of the final product. Most suppliers are dock to stock unless supplier corrective actions have been issued. Some suppliers are determined by the customer’s requirements. Rapport Inc’s suppliers are evaluated to meet the business needs of the company. Criteria for supplier selection, or evaluation is documented and the results, along with necessary actions arising from the evaluation is maintained (see 4.2.4) 7.4.2 Purchasing Information: Purchased parts and subassemblies are adequately described on the purchase order to ensure conformance to specifications, including the following as necessary: • Requirements for approval of product, procedures, processes and equipment. • Quality management system requirements. • Requirements for qualification of personnel. All purchasing documents are reviewed for accuracy and completeness before communicating to the supplier. Page 12 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 7.4.3 Verification of Purchased Product: Inspection activities have been implemented to ensure that the purchased product meets the specified purchase requirements. Rapport, Inc. or our customers, have the right, through authorized representatives and subject to reasonable notice, to perform a source inspection or otherwise evaluate the product provided by our suppliers on their premises. 7.5 Product and Service Provision: 7.5.1 Control of Production and Service Provision: Our production process plans are established to ensure they are implemented under controlled conditions. These conditions include: • The availability of what describes the characteristics of the product. • The availability of procedures or work instructions as necessary. • The use of equipment suitable for our manufacturing processes. • The availability and use of suitable monitoring and measuring devices. • The implementation of monitoring and measuring. • The implementation of product release, delivery and post-delivery activities. 7.5.2 Validation of Processes for Production and Service Provision: This section does not apply to Rapport, Inc. 7.5.3 Identification and Traceability: Where appropriate we have identified product by suitable means throughout the product realization process. A product status is identified throughout the product realization process. Where tractability is required, Rapport, Inc. has established a system to trace specific material, components or equipment. 7.5.4 Customer Property: Whenever customer property is provided for use or incorporation into product, Rapport, Inc. exercises care in control of the property. Customer property is identified, and documented to ensure appropriate tractability. Methods of control that are specified by the customer, if applicable, are documented in the customer’s contract. In the event that customer property is lost, damaged or otherwise found unsuitable for use, records of the nonconformance are maintained, and the customer is notified. 7.5.5 Preservation of Product Processes are defined and implemented to ensure that products and components are identified, handled, packaged and stored in a manner to maintain conformity to requirements. Page 13 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 7.6 8.0 Control of Monitoring and Measuring Devices: The methods of monitoring and measuring are defined, and appropriate devices are used to provide evidence of conformity of product. Processes are established to ensure that monitoring and measurement takes place in accordance with the appropriate monitoring and measurement criteria. To ensure valid results, measuring equipment shall: • Be calibrated, verified, or both, at specified intervals or prior to use, against measurement standards that are traceable to international or national standards. Where no standards exist, the basis for verification of equipment is recorded. • Measuring equipment can be adjusted or readjusted as necessary. • Calibration status of all equipment is appropriately identified, and where calibration is not necessary, equipment is labeled as such. • Measuring equipment is protected from adjustments that would invalidate the measurement result. • Measurement equipment is handled, stored and maintained in a manner to prevent damage and preserve its accuracy for use. In the event that a monitoring or measuring device is found to be out of calibration, the device is removed from service, the product is segregated, and handled to ensure prior measuring results are verified and that procedure are followed that deals with products that do not conform to requirements. All records for calibration and verification are maintained. (See 4.2.4) Measurement, Analysis & Improvement: 8.1 General: Rapport Inc. has in place a quality management system that supports the monitoring, measuring, and analyzing information, as to whether the organization meets customer requirements and to validate continuous improvement activities. 8.2 Monitoring and Measurement: 8.2.1 Customer Satisfaction: Several sources to measure and evaluate customer satisfaction, including: • Customer satisfaction surveys and product feedback • On-time delivery and shipment data • Customer complaints and requests for Corrective action • Rework and repair records • Customer audits of the quality management system. This data is complied and reviewed by management at regular intervals with the intent of implementing improvements to customer satisfaction. Page 14 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 8.2.2 Internal Audits: Internal Audits are conducted at planned intervals to provide evidence that the quality management system is effectively implemented and maintained and conforms to the requirement of planned arrangements and the ISO 9001 International Standard. Internal audit results are reported immediately following the audit and as part of management review input. An annual audit schedule is determined, and areas/processes are scheduled for audit, based on their status, importance and past audit results. Audit methods, criteria, scope and frequency are defined in a documented procedure, along with the responsibilities and requirements for planning, conducting, reporting results and maintaining audit records. Auditors shall not audit their own work. Management is responsible for the area being audited and ensuring that timely actions are taken. Follow-up activities include verification of the actions taken and a report of verification results. 8.2.3 Monitoring and Measurement of Processes: Suitable methods are applied for monitoring and where applicable, measurement of the processes that make up the quality management system. These methods demonstrate the ability of the processes to achieve planned results. Where a process is monitored for effectiveness, the suitable method of monitoring and measurement is documented on the process flowchart or procedure for that process. 8.2.4 Monitoring and Measurement of Products: Throughout the product realization process, products are inspected and tested at planned stages to verify that product requirements are being met. Products are not authorized for release to finished goods until it is verified that all stages of the work order have been satisfactorily completed, and that all acceptance criteria has been met. 8.3 Control of Nonconforming Product: Documented procedures exist that define the process for controlling nonconforming product. The disposition of nonconforming product is handled in accordance with procedures, and many include any of the following options: • Action can be taken to eliminate the nonconformity by repairing or reworking the product. This is done in accordance with applicable standards and is subject to reverification, to demonstrate conformity to the original criteria. • May be “use as is” and released under concession, with authorization from the appropriate management personnel, or the customer, if applicable. • The nonconforming product is removed from use, and either scrapped or returned to the original supplier if applicable. Records of nonconforming material, including actions taken, are maintained and reviewed as part of the continual improvement process. Page 15 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 8.4 Analysis of Data: As part of continuous improvement effectiveness of the quality management system, data is collected and analyzed from multiple sources: • Customer delivery times, customer complaints, customer surveys and feedback. • Product conformity information gathered from monitoring and measuring processes during manufacturing, inspection testing, including results of nonconformance records to ensure that they do not reoccur. • Process and product trends and characteristics that would provide opportunities for preventive action. • This data is reviewed and analyzed at planned intervals, and during management review. 8.5 Improvement: 8.5.1 Continual Improvement Commitment to continual improvement of the effectiveness of the quality management system is accomplished by: • Setting a company-wide quality policy that reflects this commitment and ensuring that it is known and understood at all levels of the organization. • Setting quality objectives and ensuring total company involvement is achieving these objectives. • Conducting internal audits, recommending areas for improvement during audits and reviewing audit results. • Reviewing and analyzing quality data • Ensuring an effective program for corrective and preventive action 8.5.2 Corrective Action: Action is taken to ensure that conditions adverse to product and service quality are identified, investigated and corrected in order to prevent recurrence. All employees are responsible for initiating the corrective action process if any nonconformances are identified. A documented procedure is established to define the requirements for: • Reviewing process or product nonconformance, which include customer complaints. • Determining the root cause of the nonconformance. • Evaluations of the need for action to ensure that nonconformance’s do not recur. • Determining and implementing appropriate corrective action, including and retraining if necessary. • Maintaining records of the results of action taken • Conducting follow-up activities to review results and ensure that the action taken is effective. Page 16 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 8.5.3 Preventive Action As a part of our commitment to continual improvement, Rapport, Inc. identifies potential causes of a nonconformance and takes action to prevent the occurrence. A documented procedure is established to define the requirements for: • Determining potential nonconformance and their causes and assigning the preventive action task to the relevant personnel. • Evaluating the need for action to prevent occurrence of nonconformance’s • Determining and implementing action that is appropriate to the effects of potential problems. • Maintaining records of the results of action taken. • Reviewing preventive action taken to ensure that nonconformance’s do not occur and ensure that the action taken is effective. 9.0 Procedure and records Matrix: This section referenced the procedures and forms that are specifically required by ISO 9001 International Standard. Additional procedures, process flowcharts and records may exist and are referenced accordingly throughout the applicable sections of this manual. 10.0 Authorization: Department Quality Assurance Representative Authorization Vice President Dale Lehman Thomas Derryberry Page 17 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it. 11.0 Revision History: Issue # 01 02 03 04 05 Changes Initial Release of QA Manual Include process map Added statement to Scope section excluding Rapport Inc. from Element 7.3 of ISO 9001:2000 Added exclusion section 4.2.2 page 5 Re-write of QA manual to ISO 90012008 requirements DCC # 7001 8002 Date 1/5/2007 4/14/2008 8/19/08 12/05/08 07/01/09 06 Re-write of Quality objectives 11/20/09 07 Re-write of Quality objectives and Rewording 5.2 to exclude design 01/17/11 08 Reviewed for effectiveness and updated to reflect process changes and improvements. Annual review for effectiveness and to incorporate Car-Go Battery Co. Corrected grammar, spelling, improved word usage and added in 401K Retirement Plan. 8/01/2011 09 10 Annual review for change to 5.4.1 Quality Objectives and also to 5.5.2 pertaining to employee reviews. 5/23/2012 9/30/2013 Page 18 of 18 QM 9001 Rev 10 Once printed, the revision level of this document must be verified against the on-line document master. If this printed document is not current, destroy it.
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