Quality Management System Manual

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1 Quality Management System Manual 10V Gill Street Woburn, MA USA 01801

2 INTRODUCTION RL CONTROLS, LLC RL Controls, LLC is a privately held company headquartered in Woburn, MA, USA. RLC has more than 80 years of mass transportation and over 100 years of technology experience among our team of managers, engineers, and technicians. RLC was founded to support the diverse technical needs within the mass transit industry. Our services include management, technical, maintenance and repair, installation and support of ITS and various vehicle controls. We understand that mass transit is diverse in nature; that it is in constant technological advancement; and that service requirements are always evolving. Our mass transit experience includes light, heavy, commuter rail and bus, and facilities infrastructure that includes: PTC and Automatic Train Control/Operation (ATC/ATO) Communication and ITS solutions that include CAD/AVL, AAS, Destination Signs LMR, various Wayside support from Access points, PTC and Information, APC and ISS Consulting and Electrical Construction support HVAC Systems Bus and Rail Vehicle Control that includes ETN, Propulsion, Diagnostics, LVPS and Vehicle Communications Installation service and support for vehicle systems with vast experience with all systems and suppliers throughout the U.S.A. supporting Rail, Bus and Non-Revenue vehicles Wire Harness builds for custom installation We are experts in the transportation maintenance industry and have MBE/WBE/DBE certifications in 32 states as well as Federal SDB/8a. Our goal is to enhance the long-term viability and integrity of relationships and equipment by facilitating useful interactions between us and our supplier s vendors and the customers we serve beyond the nuts and bolts of maintenance. RLC will help to perform gap analysis where services would create the most value that are logistically flexible. We are prepared to expand in order to meet customer needs. We maintain a list of services and project available and provide others via our website. The codes with which we are certified under are listed on the business codes page of our website. Mission Statement: RLC develops partnerships with organizations to support and augment their existing capabilities whether the goal is to expand into the United States, or to increase local presence. To build trustworthy customer relationships and customize according to the needs of each client and address every concern that can impact quality and the relationships that we value. QMS Manual RLC - rev.03 7/06/2014 2

3 TABLE OF CONTENT 4.1 General Documentation Requirements General Quality Manual Control of Documents Control of Records Management Committment Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning Responsibility, Authority and Communication Responsibility and Authority Management Representative Internal Communication Management Review General Review Input Review Output Provision of Resources Human Resources General Competence, Awareness and Training Infrastructure Work Environment Planning of Product Realization Customer Related Processes Determination of Requirements Related to the Product Review of Requirements Related to the Product Customer Communication Design and Development Design and Development Planning Design and Development Inputs Design and Development Output Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes Purchasing Purchasing Process QMS Manual RLC - rev.03 7/06/2014 3

4 7.4.2 Purchasing Information Verification of Purchased Product Production and Service Provision Control of Production and Service Provision Validation of Processes for Production and Service Provision Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Devices General Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Nonconforming Product Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action LIST OF TABLES Table 1 - Referenced procedures... 8 LIST OF FIGURES Figure 1 Quality Management System... 6 Figure 2 Interaction between departments (deleted)... Error! Bookmark not defined. Figure 3 Quality system documentation, interaction overview... 7 QMS Manual RLC - rev.03 7/06/2014 4

5 4 QUALITY MANAGEMENT SYSTEM 4.1 GENERAL This Quality Manual represents RL Control s plan to establish, document, implement and maintain a quality management system (QMS) and continually improve its effectiveness. To accomplish this plan RLC shall: a) Determine the processes needed for the quality management system and their application throughout the organization; b) Determine the sequence and interaction of these processes; c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective; d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes e) Monitor, measure where applicable, and analyze these processes, and; f) Implement actions necessary to achieve planned results and continual improvement of these processes. Where RLC chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system, its procedures and instructions. Ever mindful that RLC is a small business with limited resources, we strive to meet our Customers requirements and create value within our limited means. Think Lean! SCOPE, EVOLUTION AND MATURITY: The scope of this Manual includes all elements included in the ISO 9001:2008 International Standard, as outlined in Table I. RLC wishes to implement this quality management system (QMS) to better service its customers and their requirements. Given this goal, the organization has removed prior exclusions to the scope of the QMS. Nevertheless, it must be recognized that the organization is a recent adopter of this QMS. QMS development efforts are ongoing with the goal to migrate to more advanced levels of QMS maturity. As of this Revision 3, the QMS maturity level at RLC, as measured by instruments such as the ISO 9004:2009 selfassessment tool, is at maturity level 1 to 2. Note: The ISO 9001 standard is the basis for the ISO 9004:2009 evaluation criteria. ISO 9004:2009 promotes self-assessment as an important tool for the review of the maturity level of the organization, covering its leadership, strategy, management system, resources and processes, to identify areas of strength and weakness and opportunities for either improvements or innovations, or both. QMS Manual RLC - rev.03 7/06/2014 5

6 Figure 1 Quality Management System Using the Plan-Do-Check-Act methodology, RLC Quality Management System identifies the required processes and their application throughout the organization. These include but are not restricted to: Management Activities Provision for Resources Product Realization Measurement, Analysis and Improvement 4.2 DOCUMENTATION REQUIREMENTS GENERAL RLC s Quality Management System documentation includes: a) a documented quality policy and measurable quality objectives that have been established to provide a focus to direct the organization and the commitment to continual improvement (Reference PR400); b) a quality manual, which provides consistent information about the company s quality management system; c) documented procedures that provide the basis of the Quality Management System in support of the Quality Policy and its objectives; d) documents needed by RLC to ensure the effective planning, operation and control of its process. These include work instructions and quality plans; e) records that provide objective evidence of activities performed or results achieved. Figure 2 DELETED at rev.3 QMS Manual RLC - rev.03 7/06/2014 6

7 Figure 3 Quality system documentation, interaction overview QMS Manual RLC - rev.03 7/06/2014 7

8 4.2.2 QUALITY MANUAL RLC has established and maintains a quality manual that includes: a) the scope of the quality management system; b) reference to the documented procedures established for the quality management system (see Table I); c) a description of the interaction between the processes of the quality management system (see Figure 3). Table 1 - Referenced procedures Section Description - ISO 9001:2008 Quality Manual Supporting Document(s) Section Quality Management System Quality Manual General Requirements 4.1 PR400, Wl400-01, Wl Documentation requirements 4.2 PR400 General PR400 Quality manual PR400 Control of documents PR400 Control of records PR400 Management responsibility 5 PR401 Management commitment 5.1 PR401 Customer focus 5.2 PR401 Quality policy 5.3 PR401 Planning 5.4 PR401 Quality objectives PR401 Quality management system planning PR401 Responsibility, authority & communication 5.5 PR401, WI Responsibility and authority PR401 Management representative PR401 Internal communication PR401, WI401-01, WI Management review 5.6 PR401 General PR401 Review input PR401 Review output PR401 Resource management 6 PR402 Provision of resources 6.1 PR402 Human resources 6.2 PR402 General PR402, WI402-01, WI Competence, training and awareness PR402, WI402-03, WI Infrastructure 6.3 PR402, WI Work environment 6.4 PR402, WI402-06, WI Product realization 7 PR404 Planning of product realization 7.1 PR404 Customer related processes 7.2 PR403 Determination of requirements related to the product PR403 Review of requirements related to the product PR403 Customer communication PR403 Design and development 7.3 PR404 Design and development planning PR404 Design and development Inputs PR404 Design and development outputs PR404 Design and development review PR404 Design and development verification PR404 Design and development validation PR404 Control of design and development changes PR404 WI Purchasing 7.4 PR405 Purchasing process PR405 WI (International) -02 (State Side)I Purchasing information PR405 FM (International) Verification of purchased product PR405 WI WI Production and service provision 7.5 PR406 Control of production and service provision PR406, W , W , QMS Manual RLC - rev.03 7/06/2014 8

9 Section Description - ISO 9001:2008 Quality Manual Supporting Document(s) Section Validation of processes for production and service provision PR406, WI WI XX, WI XX Identification and traceability PR406, W1406-0I, WI Customer property PR406 WI406-16, WI406-17, Preservation of product PR406, WI Control of monitoring and measuring devices 7.6 PR407, WI Measurement, analysis and improvement 8 PR408 General 8.1 PR408 Monitoring and measurement 8.2 PR408 Customer satisfaction PR408, WI Internal audit PR408 Monitoring and management of the process PR408, WI Monitoring and measurement of product PR408 Control of nonconforming product 8.3 PR408, WI Analysis of data 8.4 PR408, KPI Improvement 8.5 PR408 Continual improvement PR408, FM408-8D Corrective action PR408, FM Preventive action PR CONTROL OF DOCUMENTS Documents required by RLC quality management system are controlled. RLC s documented procedure to define the controls needed in compliance with this standard is PR400. This procedure defines the controls used by RLC to: a) Review, update and approve as necessary documents prior to issue; b) ensure changes and the current revision status of documents are identified; c) ensure relevant versions of applicable documents are legible and available; d) ensure that documents originating from external sources are identified and their e) distribution controlled; f) prevent the unintended use of obsolete documents by applying suitable identification CONTROL OF RECORDS Records are considered a special type of document by RLC and are controlled. PR400 identifies which records are controlled by RLC to provide evidence of conformity to requirements and support the effective operation of the quality management system. RLC s procedures ensure records are legible, readily identifiable and readily retrievable. PR400 also identifies the controls required to ensure records are managed to ensure their appropriate identification, protection, retention time and disposition. Records to be maintained are listed in the Quality Records procedure, and include, at minimum: 1. Record of management review (5.6.1) 2. Record of education, experience, training and qualifications (6.2.2) 3. Records needed to provide evidence that the realization processes and resulting product meet requirements (7.1 d) 4. Records of the results of the product review and actions arising thereof (7.2.2) 5. Record of design and development input (7.3.2) 6. Record of design and development review (7.3.4) 7. Record of design verification actions (7.3.5) 8. Record of design validation actions (7.3.6) QMS Manual RLC - rev.03 7/06/2014 9

10 9. Record of the results of the review of design changes (7.3.7) 10. Record of the evaluation of suppliers (7.4.1) 11. Record of unique identification of the product (7.5.3) 12. Record of lost, damaged or unsuitable customer property (7.5.4) 13. Record of the basis of calibration used when no traceable standard exists (7.6) 14. Record of the results of calibration (7.6) 15. Record of internal audits (8.2.2) 16. Records of the authority to release product (8.2.4) 17. Record of the nature of nonconformities and subsequent actions (8.3) 18. Record of the results of corrective action taken (8.5.2) 19. Record of the results of preventive action taken (8.5.3) 5 MANAGEMENT ENGAGEMENT AND LEADERSHIP 5.1 MANAGEMENT COMMITMENT RLC s Senior Managers (referred to as the Management Committee) responsibilities relative to the Quality Management System are defined in PR401. These documents identify the criteria the Management Committee use to provide evidence of its commitment to the development and implementation of the quality management system and to continually improve its effectiveness. The activities defined in the procedures include but are not limited to: a) communicating to the organization the importance of meeting customer and statutory and regulatory requirements; b) establishing the quality policy; c) ensuring that quality objectives are established; d) conducting management reviews; e) ensuring the availability of resources. 5.2 CUSTOMER FOCUS RLC s Management Committee complies with PR401 to ensure that customer requirements are determined and met, with the focus on enhancing customer satisfaction through the systems established for document control as well as the review of information presented to the Management Committee by key members of each department. 5.3 QUALITY POLICY RLC s Management Committee complies with PR401 to ensure the quality policy: a) is appropriate to the purpose of the company; b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system; c) provides a framework for establishing and reviewing quality objectives; d) is communicated and understood within the organization. QMS Manual RLC - rev.03 7/06/

11 5.4 PLANNING The Management Committee complies with activities defined in PR401 to ensure quality objectives, including those needed to meet requirements for products, are established for relevant functions and levels within the company QUALITY OBJECTIVES The Management Committee ensures the stated objectives are measurable and consistent with the Quality Policy QUALITY MANAGEMENT SYSTEM PLANNING The Management Committee has the responsibility to comply with PR401. These procedures have been designed to ensure: a) the planning of the quality management system is completed; b) the requirements of the quality objectives can be met; c) the integrity of RLC s quality management system is maintained when changes to it are planned and implemented. 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION RESPONSIBILITY AND AUTHORITY The Management Committee ensures PR401 is reviewed and revised as changes occur within the organization to ensure that responsibilities and authorities for various activities which support the quality management system are defined and communicated within the company MANAGEMENT REPRESENTATIVE In compliance with PR401 the Principal Owner of RLC has appointed a Quality Manager irrespective of his other responsibilities to have responsibility and authority which includes: a) ensuring that processes needed for the quality management system are established, implemented and maintained; b) reporting to the Management Committee on the performance of the quality management system and any need for improvement; c) ensuring the promotion of awareness of customer requirements throughout the organization INTERNAL COMMUNICATION The Management Committee complies with PR401 in taking steps to ensure that appropriate communication processes are established within the organization and that communication regarding the effectiveness of the quality management system is undertaken. Various means of communication are used; s, meetings and general gatherings. 5.6 MANAGEMENT REVIEW GENERAL The Management Committee complies with PR401 during its reviews of RLC s quality management system. The Management Committee ensures the reviews are performed at QMS Manual RLC - rev.03 7/06/

12 planned intervals to ensure the system s continuing suitability, adequacy and effectiveness. The procedure requires that reviews include: a) assessing opportunities for improvement; b) assessing the potential need for changes to the quality management system REVIEW INPUT Information reviewed by the Management Committee includes but is not restricted to the following items as defined in PR401: 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) required changes that could affect the quality management system g) recommendations for improvement REVIEW OUTPUT Output from the Management Committee s review of the quality management system is formally documented as per PR401 and may include but is not restricted to: a) improvement of the effectiveness of the quality management system and its processes; b) improvement of product related to customer requirements; c) identification of resource needs. 6 RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES RLC management s responsibilities for determining and providing needed resources are defined in PR402. These responsibilities include, but are not restricted to, defining resources needed to implement and maintain the quality management system and continually improve its effectiveness and enhance customer satisfaction by meeting customer requirements. 6.2 HUMAN RESOURCES GENERAL RLC s management complies with PR402 to ensure personnel performing work affecting product quality are deemed competent on the basis of appropriate education, training, skills and experience COMPETENCE, AWARENESS AND TRAINING Individuals holding specific functional roles within RLC are assigned responsibilities that are identified in PR402 to: a) determine the necessary competence for personnel performing work affecting product quality; b) provide training or take other actions to satisfy needs; c) evaluate the effectiveness of actions taken; QMS Manual RLC - rev.03 7/06/

13 d) ensure that RLC s personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives; e) maintain appropriate records of education, training, skills and experience. 6.3 INFRASTRUCTURE In compliance with the requirements defined in PR402 specified managers are responsible for determining, providing and maintaining the infrastructure needed to achieve conformity to product requirements. The requirements include providing, where applicable, buildings, workspace and associated utilities, process equipment (both hardware and software) and supporting services (i.e., transport or communication). 6.4 WORK ENVIRONMENT Specified Managers are assigned the responsibility to determine and manage the work environment needed to achieve conformity to product requirements in compliance with and as defined in PR PRODUCT REALIZATION 7.1 PLANNING OF PRODUCT REALIZATION Planning of product realization is performed by taking into consideration management activities, provision of resources, and requirements for measurement, analysis and improvement in keeping with the general focus of our quality management system. In planning for Product Realization, the individuals involved with the process determine the following (as appropriate): a) quality objectives and requirements for the product; b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements. RLC documents the resulting plan, and the corresponding action items are distributed as required. The final plan summary is referred to as a Quality Plan. 7.2 CUSTOMER RELATED PROCESSES DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT In compliance with PR403 RLC determines: a) requirements specified by the customer, including the requirements for delivery and post-delivery activities; b) requirements not stated by the customer but necessary for specified or intended use (where known); c) statutory and regulatory requirements related to the product; d) any additional requirements determined by RLC. QMS Manual RLC - rev.03 7/06/

14 7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT RLC reviews requirements related to the product prior to making a commitment to supply a product to the customer. In keeping with PR403 the appropriate managers ensure that: a) product requirements are defined b) contract or order requirements differing from those previously expressed are resolved c) RLC has the ability to meet the defined requirements. d) Records of the reviews are maintained. In the event the customer does not provide a documented statement of requirement, RLC confirms the customer requirements before acceptance. In the event requirements are changed, RLC ensures that relevant documents are amended and that the appropriate personnel are made aware of the change in the requirements CUSTOMER COMMUNICATION The individuals identified in PR403 comply with the activities defined within the procedure to determine and implement effective arrangements for communicating with customers in relation to: a) product information; b) inquiries, contracts or order handling, including amendments; c) customer feedback, including customer complaints. 7.3 DESIGN AND DEVELOPMENT Design and Development activities under RLC s responsibility, whether performed internally or by external partners, shall be planned and controlled as per the following guidelines and as detailed in the appropriate sections of procedure PR404 Product Realization DESIGN AND DEVELOPMENT PLANNING The planning and controlling of the design and development of product shall include the following elements: a) a definition of the design and development stages; b) the review, verification and validation that are appropriate to each design and development stage; c) the responsibilities and authorities for design and development. RLC shall manage the interfaces between different groups involved in design and development to ensure the effective communication and clear assignment of responsibility. Planning output shall be updated and distributed appropriately as the design and development progresses DESIGN AND DEVELOPMENT INPUTS Design and Development inputs shall include but are not restricted to the following: a) functional and performance requirements; QMS Manual RLC - rev.03 7/06/

15 b) applicable statutory and regulatory requirements; c) where applicable, information derived from previous similar designs; d) other requirements essential for design and development. Records of Design and Development inputs must be maintained (per 4.2.4). All inputs are reviewed for adequacy and to ensure the requirements are complete, unambiguous and not in conflict with each other DESIGN AND DEVELOPMENT OUTPUT The outputs of design and development shall be in a form suitable for verification against the design and development input. D&D outputs shall be approved prior to release. Design and development outputs must: a) meet the input requirements for design and development; b) provide appropriate information for purchasing, production and service provision; c) contain or reference product acceptance criteria; d) specify the characteristics of the product that are essential for its safe and proper use DESIGN AND DEVELOPMENT REVIEW At suitable stages, systematic reviews of design and development activity shall be performed in accordance with planned arrangements (see 7.3.1). The intent is to: a) evaluate the ability of the results of design and development to meet requirements; b) identify any problems and propose necessary actions. c) ensure that all the requirements as stated are complete, unambiguous and not in conflict with each other Participants in such reviews shall include representatives of the functions involved with, or affected by, the design and development stages being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4) DESIGN AND DEVELOPMENT VERIFICATION Note: Verification activities include review of product design specification outputs such as drawings, prototypes, process plans, etc., to meet Requirement inputs. Verification must be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of verification and any necessary action items must be documented and maintained (see 4.2.4) DESIGN AND DEVELOPMENT VALIDATION Note: Validation activities include inspection and testing. Validation must be performed in accordance with planned arrangements (see 7.3.1). QMS Manual RLC - rev.03 7/06/

16 Design and development validation is performed to ensure that the resulting product is capable of meeting the requirements for specified application or intended use (where known). Wherever practical, validation must be completed prior to the delivery or implementation of the product. Records of the results of validation activities and any necessary action items are documented and maintained (see 4.2.4) CONTROL OF DESIGN AND DEVELOPMENT CHANGES Design and Development changes shall be identified and records maintained (see 4.2.4). The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of Design and Development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. 7.4 PURCHASING PURCHASING PROCESS RLC ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to suppliers and the purchased product is dependent on the effect of the purchased product on subsequent product realization or the final product. RLC evaluates and selects suppliers based on their ability to supply product in accordance with RLC s specified requirements. All of the activities identified above as well as the criteria for selection, evaluation and re-evaluation are established in PR405. The results of evaluations and any necessary actions arising from the evaluation are documented and maintained PURCHASING INFORMATION RLC compiles the following information in compliance with PR405 to describe the product to be purchased, including: a) requirements for approval of product, procedures, processes and equipment; b) requirements for qualification of personnel; c) quality management system requirements. In addition, RLC ensures the adequacy of specified purchase requirements prior to their communication to the supplier VERIFICATION OF PURCHASED PRODUCT RLC has established and implemented PR405 to ensure the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements are completed. PR405 identifies that in the event RLC or its customer intends to perform verification at a supplier s premises, RLC will state the intended verification arrangements and method of product release in the purchasing information. QMS Manual RLC - rev.03 7/06/

17 7.5 PRODUCTION AND SERVICE PROVISION CONTROL OF PRODUCTION AND SERVICE PROVISION RLC has defined its plans and processes to carry out production and service provisions under controlled conditions in PR406. The controlled conditions include where applicable: a) the availability of information that describes the characteristics of the product; b) the availability of work instructions; c) the use of suitable equipment; d) the availability and use of monitoring and measuring devices; e) the implementation of monitoring and measurement; f) the implementation of release, delivery and post-delivery activities VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION RLC validates any processes for production and service provision where subsequent monitoring or measurements cannot verify the resulting output. PR406 provides the instruction for ensuring the information is developed and implemented as process, products and services are developed and/or changed. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. RLC s validation practices have been designed to demonstrate the ability of these processes to achieve planned results. The procedures identify the actions required for these processes and include where applicable: a) defined criteria for review and approval of the processes; b) approval of equipment and qualification of personnel; c) use of specific methods and procedures; d) requirements for records; e) revalidation IDENTIFICATION AND TRACEABILITY RLC identifies the product by suitable means throughout product realization. The criteria used are identified in PR406. Product is controlled and status is recorded and maintained for ease of retrieval to: a) monitoring and measurement requirements; b) traceability through unique identification practices (which may vary depending on the product or subset of a product) CUSTOMER PROPERTY RLC complies with instructions contained within PR406 to ensure we consistently exercise care with customer property while it is under the company s control or being used by RLC uniquely identifies, protects, and safeguards all customer property provided for use or incorporation into products. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the condition is reported to the customer and records are dutifully maintained PRESERVATION OF PRODUCT RLC preserves the conformity of product during internal processing and delivery to the intended destination as instructed in PR406. The preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of RLC s products. QMS Manual RLC - rev.03 7/06/

18 7.6 CONTROL OF MONITORING AND MEASURING DEVICES In compliance with PR407, RLC determines the monitoring and measurement to be undertaken and the monitoring and measuring devices required to provide evidence of conformity of products to determined requirements and specifications. RLC has established processes in PR407 to ensure that monitoring and measurement can be carried out and results are validated. When required to ensure valid results, RLC s choice of measuring equipment is: a) calibrated or verified at specified 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 or verification is recorded; b) adjusted or re-adjusted as necessary; c) identified to enable the calibration status to be determined; d) safeguarded from adjustment that would invalidate the measurement result; e) protected from damage and deterioration during handling, maintenance and storage. In addition, RLC assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. RLC takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. Confirmation is undertaken prior to initial use and reconfirmed at specified intervals as appropriate to the application. 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 GENERAL RLC complies with PR408 to ensure the planning and implementation of monitoring, measurement, analysis and improvement processes that are needed to: a) demonstrate conformity of the product; b) ensure conformity of the quality management system; c) continually improve the effectiveness of the quality management system. Planning and implementation includes determination of applicable methods, including statistical techniques, as well as the extent of their use. 8.2 MONITORING AND MEASUREMENT CUSTOMER SATISFACTION PR408 ensures we monitor information relating to customer perception as to whether the organization has met customer requirements. Senior management defines the methods for obtaining and using this information, The Management Committee reviews the status of customer input annually (at a minimum) INTERNAL AUDIT RLC conducts internal audits as defined in PR408 at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements; QMS Manual RLC - rev.03 7/06/

19 b) conforms to the quality management system described in the Quality Manual; c) conforms to the quality management system requirements defined in RLC s Quality Audit Checklists; d) is effectively implemented and maintained. RLC s audit program is planned and pre-scheduled annually, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined in the procedure and the supporting checklist. Selection of auditors and the conduct of the audits are designed to ensure objectivity and impartiality of the audit process. Auditors are not authorized to audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are identified in PR MONITORING AND MEASUREMENT OF PROCESSES RLC has designed and applied suitable methods for monitoring and, where applicable, measuring the quality management system processes. These methods are contained in PR408 and its supporting checklist. The methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken as appropriate to ensure conformity of the product MONITORING AND MEASUREMENT OF PRODUCT RLC monitors and measures the characteristics of its products to verify that product requirements have been met and are in compliance with PR408. The verifications are carried out at appropriate stages of the product realization process in accordance with the planned arrangements found in each product Quality Plan document. Evidence of conformity and the acceptance criteria is maintained. In addition to evidence of conformity the inspection and test records also identify the person(s) authorizing release of product. Product release and service delivery are not authorized to proceed until the planned monitoring and measurement (arrangements) have been satisfactorily completed and documented, unless otherwise approved by the appropriate authority and where applicable by customer concession. 8.3 CONTROL OF NONCONFORMING PRODUCT RLC has developed and complies with PR408 to ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The procedure also defines the controls and related responsibilities and authorities for dealing with nonconforming product. RLC deals with nonconforming product by taking one or more of the following actions: a) eliminate the detected nonconformity b) authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer c) precluding its original intended use or application. In compliance with our procedure, records of the nature of non-conformities and any subsequent actions taken, including concessions obtained, are maintained. Nonconforming product that is corrected is subjected to re-verification to demonstrate conformity to the requirements. In addition, when nonconforming product is detected QMS Manual RLC - rev.03 7/06/

20 after delivery or use has started, RLC takes action appropriate to the effect, or potential effect, of the nonconformity. 8.4 ANALYSIS OF DATA In compliance with PR408, various departments within the company collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This includes data generated as a result of monitoring and measurement as well as other relevant sources. The analysis of data provides information relating to: a) customer satisfaction; b) conformity to product requirements; c) characteristics and trends of processes and products including opportunities for preventive action; d) suppliers. 8.5 IMPROVEMENT CONTINUAL IMPROVEMENT RLC strives to continually improve the effectiveness of the quality management system through the use of the quality policy, and quality objectives, audit results, and implementing corrective and preventive actions. In addition continual improvement is also supported by the analysis of data and ensuring management review. The detailed process is defined in PR CORRECTIVE ACTION RLC takes action to eliminate the cause of non-conformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the non-conformities encountered. PR408 has been established to define RLC s requirements for: a) reviewing non-conformities (including customer complaints); b) determining the causes of non-conformities; c) evaluating the need for action to ensure that non-conformities do not recur; d) determining and implementing action needed; e) records of the results of action taken; f) reviewing corrective action taken PREVENTIVE ACTION RLC s focus is on determining action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are analyzed prior to implementation to determine their appropriateness to the effects of the potential problem(s). PR408 have been established to define requirements for: a) Determining potential non-conformities and their causes; b) Evaluating the need for action to prevent occurrence of non-conformities; c) Determining and implementing action needed; d) Records of results of action taken; e) Reviewing preventive action taken. QMS Manual RLC - rev.03 7/06/

21 9 REASON FOR RE-ISSUE Rev. 01, Implementation Date: September 1, 2007 Original Release Rev. 02, Implementation Date: March 30, 2014 Rewritten with Exclusions and Implementation Plan reference Rev. 03, Implementation Date: July 7, 2014 Table of Contents: Figure I. Correction. Removed reference to ISC. 4.1 inserted statements describing means to establish a QMS; removed prior exclusions to RLC QMS; extended QMS to outsourced processes; commented on rev.3 QMS maturity level status. 4.1 Figure 2 removed (Interaction between departments) a) removed note about exclusion d) removed note indicating TBD Table I, o (PR401) Removed exclusions for Sections 5; 5.3; 5.4; 5.4.1; 5.4.2; 5.5; 5.5.1; 5.5.2; 5.5.3; 5.6; 5.6.1; 5.6.2; o Removed note about development status for Sections 7, and 7.1. o Sections 7.3; 7.3.1; 7.3.2; 7.3.3; 7.3.4; 7.3.5; 7.3.6; Design and Development shifted from PR 406 to procedure PR404 Product Realization; references to design partner removed. o Sections 8.2.2; 8.2.3; 8.4; 8.5; 8.5.1; Removed exclusions. 5 retitled Management Engagement and Leadership 5.6.1, line 1 company name corrected. 7.3 D&D. Referenced procedure changed from PR 406 Production an Service Provision, to PR 404 Product realization; removed references to design partner as responsible party to 7.3.6, changes to syntax to add clarity. 10 APPROVAL Lena Walsh Principal/Owner William Hennigan Operations Manager/Quality Manager Sean Sutherland Quality Manager QMS Manual RLC - rev.03 7/06/

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