Quality Management System Quality Manual

Transcription

1 1788 Northpointe Rd. Columbia, TN & 5456 E. McDowell Rd. Suite 109 Mesa, AZ & 647 Westport Pkwy Grapevine, TX USA Quality Management System TABLE OF CONTENTS QUALITY MANUAL APPROVAL AND REVISION HISTORY QUALITY MANAGEMENT SYSTEM 1.0 Introduction (AS 9100C, 4.) (Objective, Scope, Quality Philosophy, etc.) 2.0 General (AS 9100C, 4.) (Organization, Background, Terms and Definitions, etc.) 3.0 Documentation Structure, Reference Documents (AS 9100C, 4.) 4.0 Controls (AS 9100C, 4.) (Documentation, Records) 5.0 Management Responsibility (AS9100C. 5.) 6.0 Resource Management (AS9100C, 6.) 7.0 Product Realization (AS9100C, 7.) 8.0 Measurement, Analysis and Improvement (AS9100C, 8.) Appendix A WireMasters Quality Management System Cross Reference to AS9100C Appendix B Quality System Operating Procedures List Figure 2-1, WireMasters, Inc. Organization Chart Figure 7-1, WireMasters, Inc. Product Realization Workflow Page 1 of 20

2 '-IZ'-.4C WireMasters...,,~""'-. WireMasters, Inc. QUALITY MANUAL APPROVAL AND REVISION HISTORY This was prepared in accordance with the requirements of AS91 OOC & ISO 9001 :2008; and approved by the WireMasters Management Team as indicated below. This replaces and supersedes all previously issued WireMasters s ;buc David C. Hill, CEO I President ~J_~ Richard Farris, VP of Operations Manager Drew Love, Direft(;of Sales and Operations oyle, Traffic Manager ~~ Dennis Thomason, CFO/Accounting Manager Cassie Adkison, QualitY. Manager Ramon Maxwell, Texas Site Manager No portion of this Manual may be copied or reproduced without the written consent of Wire Masters, Inc. Distribution and control of this Manual are provided in Paragraph 4.1 Revision Level - 0 Page 2 of21

3 Revisions to this Manual will be authorized by WireMasters Quality Manager and approved by WireMasters President, as indicated by their initials on the Revision History below. Rev Level Date Issued Pg/Sect. Ref Description of Change Orig All Reissue of Manual in its entirety Authoriz ed (Qual Mgr) (see above) Approved (President) (see above) Rev A 02/09/05 All Reissue of Manual in its entirety CAA DCH Rev B 02/08/06 All Reissue of Manual in its entirety CAA DCH Rev C 03/23/07 All Address Change CAA DCH Rev D 07/11/07 All Management Team & Organization Chart Change CAA DCH Rev E 01/02/08 All Franklin Address deleted & Sales Manager added CAA DCH Rev F 04/30/08 All Management Team Change CAA DCH Rev G 01/18/10 All Management Team Change CAA DCH Rev H 04/07/10 All Add section CAA DCH Rev I 09/30/10 All Revision of Manual to meet ISO 9001:2008 CAA DCH standards. Rev J 09/30/11 All Revision of Manual to meet AS 9100C standard CAA DCH Rev K 11/26/12 All Management Team Addition & Add Arizona Site CAA DCH Rev L 01/14/13 All Added responsibilities for Arizona Site Manager CAA DCH Rev M 02/08/13 All Added WireMasters Scope and Exclusions CAA DCH Rev N 02/25/14 All Management Team Addition, Texas Site Manager, & Quality Objectives Rev O 07/09/14 All Management Team Addition & Management Title Changes CAA CAA DCH DCH Page 3 of 20

4 1.0 INTRODUCTION WireMasters, Inc. is a quality provider of wire, cable, and related products in accordance with industry standards, military specifications, and customer and regulatory requirements. In order to provide products and services that comply with all requirements and standards, and assure complete customer satisfaction, WireMasters has established a single-standard Quality Management System that meets the requirements of Aerospace Quality Management Systems Standard, AS9100C and ISO 9001:2008. In accordance with AS9100C and ISO 9001:2008 WireMasters scope is; Tennessee location: Aviation and military wire, cable and connector distribution. Services include printing, striping, twisting and labeling of cable and wire. Manufacture of custom labeling of heat shrink tubing and custom cables to military specifications. Arizona location: Aviation and Military wire, cable and connector distribution. Services include re-spooling, re-packaging, labeling of wire & cable and stocking inventory. Texas location: Aviation and Military wire, cable and connector distribution. Services include re-spooling, re-packaging, labeling of wire & cable and stocking inventory. Exclusions WireMasters reserves the right to exclude itself from requirements within Clause 7. Exclusions applicable to this clause are as follows: 7.3 Design & Development; WireMasters primarily supplies wire, cables and related products for which designs are controlled by Military and Industry specifications and standards. Customers generally specify their requirements via reference to these specifications and standards. WireMasters has no design authority or responsibility for products specified to the requirements of these documents. WireMasters is excluding itself from 7.3 (TN, AZ & TX locations) Post-Delivery support; WireMasters does not provide post-delivery support and therefore WireMasters is excluding itself from (TN, AZ & TX locations) Page 4 of 20

5 7.5.2 Validation of Processes for Productions and Service Provision; WireMasters does not perform any special processes for validation at the Arizona & Texas location. WireMasters Arizona & Texas location is excluding itself from (AZ & TX locations only) Exclusions listed above do not affect the organization s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. The WireMasters Quality Management System addresses the roles, responsibilities and activities of all components of the WireMasters value delivery chain internal and external and is defined by this and the documentation referenced herein. A cross reference of content of this Manual, and the supporting procedural documentation referenced herein, to the requirements of AS9100C is provided in Appendix A. 2.0 General It is WireMasters belief that, QUALITY IS NOT EXPENSIVE, IT IS PRICELESS, and that the maintenance of a robust Quality Management System is a key part of an effective total business strategy to assure profitability, growth and complete customer satisfaction, thus providing maximum value to its investor s, customers, employees, suppliers, business partners, and the community Therefore the WireMasters Quality Management System covers all aspects of the value delivery chain and requires the direct participation of people in all parts of the organization, and of customers, suppliers and other business partners as appropriate. ORGANIZATION The WireMasters organizational chart (Figure 2-1) provides the necessary organizational references for the WireMasters Quality Management System as defined by this Manual and referenced supporting documentation. Page 5 of 20

6 TERMS AND DEFINITIONS WireMasters, Inc. References to existing terms, concepts, definitions and standards are interpreted in accordance with AS9100C and ISO 9001:2008. Rubicon Wiremasters integrated order management system. It is the primary tool for gathering and documenting customer order requirements, and for specifying and controlling internal processing, packing and shipping in order to meet those requirements. WireMasters Management Team Collectively, the managers with primary responsibility for the development, implementation and maintenance of the Quality Management System. The Team is made up of WireMasters President and all of his direct reports as identified in WireMasters Organizational Chart (Figure 2-1). 3.0 Quality Management System Definition - Documentation Structure, Reference Documents (AS9100C, 4.) WireMasters Quality Management System is defined by this and by related Quality System and Operating Procedures (QSOP s). The content, structure and controls for these documents are provided in Section 4.0 of this manual. Specific activities required by the WireMasters Quality Management System may be further defined by work instructions, checklists, guidelines, etc. as referenced in this Manual and/or defined by QSOP s. Content, structure and controls for these instructional level documents will be defined to the extent necessary in this Manual or in the appropriate QSOP. Other externally generated reference documents are utilized within the WireMasters Quality Management System, including: AS9100C, (Aerospace Standard), Quality Management Systems Aerospace Requirements ISO 9001:2008 (International Standard), Quality Management Systems Requirements Mil-Specs (Products) Industry Specifications and Standards Customer Specifications These have been determined by WireMasters to be necessary for the planning and operation of the quality management system. Internal WireMasters Controls for these documents are defined in Paragraph 4.0, and in QSOP and QSOP Page 6 of 20

7 4.0 Quality Management System Controls 4.1 Documentation WireMasters Quality Control Manager is responsible for the issuance, distribution, maintenance and control of this Controlled copies of this Manual will be issued on yellow paper to selected WireMasters Management Team members. The Quality Control Manager will maintain a list of controlled copies issued. Uncontrolled copies (on white paper) are available upon request for reference only on a needs basis as determined by the Quality Control Manager The Manual will be reviewed at a management staff level at least once per year to ensure continued pertinence and adequacy. This review will be scheduled and coordinated by the Quality Control Manager concurrent with the development of WireMasters annual operating plans and budgets, and the Quality Control Manager will maintain a record of this review Quality System and Operating Procedures (QSOP s) The Quality Control Manager will be responsible for the approval, issuance, distribution, maintenance, revision and control of QSOP s Controlled copies of QSOPs will be issued on yellow paper and made available to WireMasters personnel with assigned Quality Management System Responsibilities. The Quality Control Manager will maintain a list of controlled copies issued. Uncontrolled copies (on white paper) are available upon request for reference only on a needs basis as determined by the Quality Manager A listing of current QSOP s will be maintained and each QSOP will be reviewed at least annually as a part of the WireMasters Internal Audit Program (Ref QSOP 8.2-2). A list of QSOP s is provided in Appendix B Instructions Instructions will be generated and maintained by the appropriate functional manager as specified in this Manual or the applicable QSOP. These will include work instructions, checklists and guidelines. Page 7 of 20

8 4.2 Records WireMasters maintains and controls documents, including records, determined by the company to be necessary to ensure the effective planning, operations and control of its processes; and to provide evidence of product and process conformance, and of the effective operation of the Quality Management System. Requirements for specific records are contained in this Manual and in applicable QSOP s. QSOP contains additional procedures, controls and guidelines for the identification, storage, protection, retrieval, retention and disposition of records (both of internal/external origins). To the greatest extent practical, the WireMasters Quality System utilizes standard record forms. These forms are referenced and copies provided in the pertinent QSOPs, along with responsibilities for their development, maintenance, issuance and utilization. The Quality Control Manager maintains the master file of current record forms, except as specified in individual QSOP s. Records shall remain legible, readily identifiable and retrievable for review by customers and regulatory authorities in accordance with contract or regulatory requirements. Note: A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. Page 8 of 20

9 5.0 Management Responsibility WireMasters, Inc. 5.1 Management Commitment The top management of WireMasters has demonstrated its commitment to the development and implementation of the quality management system through the actions described in the following sections. 5.2 Customer Focus The top management of WireMasters ensures that customer requirements are by the processes described in 7.2 and that performance is measured as described in Quality Policy In line with WireMasters business philosophy that QUALITY IS NOT EXPENSIVE, IT IS PRICELESS, our quality policy is; TO FULLY MEET OR EXCEED OUR CUSTOMERS EXPECTATIONS BY PROVIDING: PRODUCT THAT MEETS ALL REQUIREMENTS AND IS DEFECT- FREE ON-TIME DELIVERY UNSURPASSED SERVICE IN ALL ASPECTS OF THE BUSINESS RELATIONSHIP ALL AT COMPETITIVE COST 5.4 Quality Objectives (see QSOP for more details) Delivered Order Quality RMAs/Orders Shipped (Target is 98% Acceptance). Supplier Quality of 90% or higher. On Time Deliveries Warehouse Productivity (Target is 90% On Time). Customer Service Score of at least 90% as determined by Customer Service Survey Response of Very Good or Excellent for Overall Service. Warehouse Error RMA S Target for TN Warehouse Error s is less than 100 for the year. Target for AZ & TX Warehouse Error s is less than 25 for the year. Quality Management System Planning The top management of WireMasters ensures that improvement objectives are set and progress monitored and that the quality management system is implemented and its integrity maintained whenever changes are made. Page 9 of 20

10 WireMasters performs Quality Planning at two (2) primary levels the Business Level and the Order Level: Business Level Quality Planning integrates Quality Control with WireMasters business and operating management. This integration is defined in Section 6.0, Resource Management, and Section 8.0, Measurement, Analysis and Improvement, of this Manual and associated QSOP s. Order Level Quality Planning assures that all customer requirements are met on each order delivered. This planning is defined by Section 7.0 of this Manual, titled Product Realization and associated QSOP s. 5.5 Responsibility and Authority Implementing the above Quality Policy requires the direct participation of all WireMasters personnel. Specific Quality Management System responsibilities of appointed WireMasters Management and Staff are provided in this Manual and the documents referenced herein, as appointed by top company management, irrespective of other responsibilities. Overall responsibilities for the Quality Management System are as follows: The President is responsible for providing the resources necessary to implement and maintain the WireMasters Quality Management System. Resource requirements are reviewed as an integral part of the annual budget and as required during management meetings. He also has primary responsibility for communicating the Quality Policy and information regarding Quality Management System performance to the organization. The Quality Control Manager is the Management Representative with overall responsibility and authority for the definition and performance of the Quality Management System. This includes but is not necessarily restricted to, Establishing and Maintaining the Quality Management System Managing the Quality Control Function Internal Audit Measuring and reporting Quality Control performance Assuring Continuous Improvement Promoting Awareness of Customer Requirements Throughout the Organization Acting as the Quality Control liaison between the company and external parties on the matters relating to the Quality Management System Page 10 of 20

11 The Management Representative has unrestricted access to top management to resolve quality management issues. Sales and Marketing is responsible for obtaining, documenting, verifying and communicating all customer quality requirements, and is the primary point of contact for all issues related to customer satisfaction. Purchasing is responsible for documenting and communicating all quality requirements to suppliers for purchased materials and outsourced processing. Operations (Warehouse, Picking, Processing, Packing and Shipping) is responsible for receiving, storing, picking, processing, packing and shipping product so that it meets the requirements of the customer order. Operations Manager is designated as deputy manager if the Quality Control Manager is not available. Arizona Site Manager is responsible for receiving, storing, picking, processing, packing and shipping product at the AZ Site so that it meets the requirements of the customer order. AZ Site Manager is designated as Quality Control for this site. Texas Site Manager is responsible for receiving, storing, picking, processing, packing and shipping product at the TX Site so that it meets the requirements of the customer order. TX Site Manager is designated as Quality Control for this site. MIS is responsible for installing, operating and maintaining Rubicon and other key operating systems. MIS infrastructure for AZ and TX site is taken care of through home office. Sales Support is responsible for providing the necessary training and support for the use of Rubicon in order to assure that sales personnel are proficient in its use. Sales Support also provides support for Sales as needed. 5.6 Management Review Reviews of the quality management system are held at regular intervals. These are attended by the top management of WireMasters. Page 11 of 20

12 Inputs to these reviews include results of audits, customer feedback, corrective and preventive actions, and progress with matters raised in previous reviews and areas identified for improvement. Outputs from these reviews include actions to be taken to improve the quality management system, its processes and the company s products and also any resource needs that may be identified. 6.0 Resource Management 6.1 Provision of Resources, Infrastructure WireMasters has established the necessary resources and infrastructure in order to meet the expectations of its customers and all regulatory requirements. These include, but are not necessarily restricted to: Our facilities (consisting of the TN warehouse, AZ warehouse, TX warehouse, and adjoining offices), workspaces, equipment, software, utilities and support services (including information systems as maintained by the MIS Department from the home office). An Order Management System (Rubicon) that provides organization-wide visibility and continuous control of Customer Orders from the definition of requirements through delivery. 6.2 Human Resource Management WireMasters recognizes the importance of personnel and personnel development in meeting the expectations and requirements of its customers and all regulatory entities. It is our policy to ensure that personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience. This policy applies to fulltime, part-time and temporary employees. The Human Resource Manager maintains job descriptions for each individual, including their responsibility and authority with respect to the Quality System. New hires are selected based upon ability to meet the needs of these job descriptions. New and existing employees are provided with the necessary orientation and training in order to meet the requirements of their jobs. Sales Support provides necessary training to all new and existing employees regarding the use of Rubicon. WireMasters Management maintains a Training Log that documents training and orientation delivered to employees. Page 12 of 20

13 Staffing levels and organizational responsibilities are established to most effectively carry out the work of the Quality Management System, and are continuously reviewed by the WireMasters Management Team and adjusted as necessary. The WireMasters Management Team regularly reviews the knowledge, capability and skill needs of the organizations against those available. In any instances where there is a gap between needs and capability, the functional manager will take the necessary steps, where applicable, to provide training or take other actions to achieve the necessary competence level. This may include training and skills development for existing employees, or the use of consultants or other outside expertise. 6.3 Integration of Resource Management with Business and Operating Management The Quality Control Manager is an active participant in WireMasters business and operating management and is responsible for determining and responding to needs for the following, New or Revised Quality Management System Policies, Procedures, Instructions and other documentation Additional or Special Quality Management System Controls New or Upgraded Quality Measurement Capabilities Infrastructure Upgrades in Support of the Quality Management System Supporting Services (such as transport, communication or information systems) Work Environment Upgrades to Support the Quality Management System Additional Personnel and Personnel Development to Support the Quality Management System 6.4 Work environment: WireMasters has established the necessary work environment to meet expectation of its customers and all regulatory requirements. WireMasters established a warehouse and production facility with the necessary environmental controls for factors including physical and environmental conditions; as well as things like noise, temperature, humidity, lighting or weather, and cleanliness. The Maintenance Manager or Site Manager of the facility will provide the necessary support to ensure the proper work environment is maintained. Maintenance Manager from home office TN warehouse works with Site Managers to meet maintenance requirements. Page 13 of 20

14 7.0 Product Realization 7.1 Planning WireMasters product realization workflow is shown in Figure 7-1. WireMasters utilizes Rubicon, an integrated order entry, material, production, packing and shipping control system as the basis for performing and controlling all necessary product realization work. Quality plans, utilizing Rubicon and other tools, are established for each individual order. These plans, required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance are defined in the subsequent sections of this Manual and in referenced Quality and Operating Procedures. WireMasters believes that the best way to assure meeting customer expectations and regulatory requirements is to establish processes and documents to provide resources specific to the product in the hands of those doing the work Project Management When planning new or modified production processes, or the introduction of a new product, a project manager will be appointed to take responsibility for the process (Ref. QSOP 7.1-1) Risk Management Wiremasters processes are subjected to a Risk Management process that identifies risks, and implements controls to mitigate risks that are judged unacceptable (Ref. QSOP 7.1-1) Configuration Management WireMasters assigns an internal part number to product ordered by customers for purposes of internal control (Ref. QSOP 4.3-1); however product configuration requirements will also be included in purchase orders to suppliers and controlled in accordance with section 7.4. Product configuration is defined by: a) Customer requirements; and, b) reference to Military and Industry Product Specifications and Standards. Customer configuration requirements are an integral part of the customer order requirements. For purposes of configuration management WireMasters maintains complete on-line access to required Military and Industry specifications and standards. In those instances where WireMasters chooses to maintain hard copies, the Quality Manager is responsible for controlling and updating these specifications as necessary (Ref. QSOP 4.3-1). Page 14 of 20

15 7.1.4 Control of Work Transfers In the event of a requirement to transfer production to another facility, a project manager will be appointed to supervise transfer and to ensure that product configuration is not compromised in any way by the transfer. This process will be handled in a similar manner to outsourcing as described in 7.4 below (Ref. QSOP and QSOP 7.4-2). 7.2 Customer Related Processes Sales are responsible for all direct customer communication related to product information and/or customer orders. They have primary responsibility for identifying and documenting Customer product requirements by entering them into the Rubicon system; in addition to obtaining/providing any additional documentation from the Customer (e.g. specifications, drawings, etc) in relation to the product ordered. The specific procedure, responsibility, mechanisms, and controls for determining, documenting and reviewing statutory, regulatory and customer requirements applicable to the product are provided in QSOP Design & Development WireMasters primarily supplies wire, cables and related products for which the designs are controlled by Military and Industry specifications and standards. Customers generally specify their requirements via reference to these specifications and standards. WireMasters has no design authority or responsibility for products specified to the requirements of these documents. WireMasters Quality Management System is excluding itself from 7.3 of our system. 7.4 Purchasing/Procurement/Outsourcing In order to meet all customer order and regulatory requirements, WireMasters purchases base material (wire, cable and related components) from manufacturers and distributors, and subcontracts selected processing. Procurement procedures, responsibilities, documentation and controls, including the verification of purchased materials and processing quality are defined by QSOP and QSOP An outsourced process is a process that WireMasters needs for its quality management system and which it chooses to have performed by an external party. WireMasters ensures control over outsourced processes does not absolve it of responsibility of conformity to all customer, statutory and regulatory requirements. Page 15 of 20

16 Page 16 of 20 WireMasters, Inc. All WireMasters suppliers (including subcontractors) are evaluated and selected based on their demonstrated production and quality capabilities. The Quality Control Department evaluates and approves new suppliers, maintains an approved supplier list, evaluates supplier performance and removes suppliers from the approved supplier list as indicated by performance. Specific procedures, responsibilities, documentation and controls are defined by QSOP Production and Service Provision Product is drawn from stock, processed, packed and shipped in accordance with customer and regulatory requirements via the order documentation generated by the Rubicon system. Control of Service Operations is excluded. Due to the nature of WireMasters product, product services are not required. Product that does not conform is replaced. Production employees have been trained in the avoidance of Foreign Object Damage. Detection and removal of foreign objects is included in the inspection checklist. (Ref. Q 33) Material furnished to WireMasters by customers will be received on a zero cost purchase order and will be processed the same as all other received material (Ref. QSOP 7.4-2). Age-sensitive material will be controlled in accordance with QSOP Additional work instructions, guidelines and checklists are provided as required. These will include necessary maintenance and control of equipment and tools utilized in the provision of products and services to the customer. The specific procedures, responsibility, mechanisms, and controls for the provision of product to customer s requirements are provided in QSOP Product is normally subject to LOT traceability controls, as defined by Customer requirements and/or Military and Industry specifications. Traceability requirements are included in Purchase Orders, and LOT traceability information is recorded for all incoming material in accordance with Purchase Order requirements. LOT identity is maintained throughout the Product Realization workflow as defined in Section 7.0 of this Manual. Warehouse Manager, Site Manager and Inventory Control Manager are responsible for preservation of product and maintenance of associated records. First Article inspection is described in

17 7.6 Control of Monitoring and Measuring Equipment WireMasters maintains measuring and test equipment necessary to verify and assure that products and processes conform to documented requirements. Equipment is maintained, calibrated, and traceable to appropriate recognized standards. Where periodic calibration is required at specific intervals, it is performed and equipment is clearly identified by a calibration label. The specific procedures, standards, responsibilities and documentation requirements (i.e. records of the results of calibration) for the control of monitoring and measuring equipment are provided in QSOP Page 17 of 20

18 8.0 Measurement, Analysis and Improvement 8.1 General WireMasters regularly evaluates the performance of and results from its Quality Management System in order to demonstrate conformity to product requirements and to ensure that it is providing the maximum ongoing value to all constituencies (customers, employees, suppliers and other business partners, the community - and WireMasters, Inc. itself), and takes appropriate corrective, preventive and improvement action based on evaluations performed. This includes Measurement of identified product and process characteristics Monitoring of key customer and management factors Analysis of data Initiation of action utilizing established action mechanisms The Quality Control Manager has primary responsibility for this aspect of the Quality Management System, but the entire WireMasters Management Team is involved. The detail of Measurement, Analysis and Improvement activities is provided in the following sections and the QSOP s referenced therein. 8.2 Monitoring and Measurement The WireMasters Management Team establishes and regularly evaluates key operating and quality characteristics, covering monitoring and measurement of all processes of the Quality management System. Monitoring and measurement will be carried out as defined below and in QSOP When Quality Management System processes do not achieve the planned results, appropriate actions or improvement will be initiated in accordance with section 8.5 of this Manual Customer Satisfaction WireMasters regularly measures the performance of the Quality Management System as it relates to meeting customer requirements and expectations including quality, on-time delivery, service and other factors and initiates action based on those measurements in order to increase value to the customer. The procedures, responsibilities, reporting, analysis and utilization of these measures are defined in QSOP Page 18 of 20

19 8.2.2 Internal Audits (Quality System Conformance and Performance) WireMasters Quality Management System places primary responsibility for meeting customer requirements and expectations in the hands of the management/staff responsible for the area being audited. It ensures that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Where required by the customer, the Quality Management System provides for formal inspection and acceptance by the Quality Department. The primary role of the Quality Department is to audit the conformance to and effectiveness of the Quality Management System; and for initiating corrective/preventative actions, identifying improvement opportunities based on the audits performed and to maintain records of internal audit activities and results. WireMasters has established and operates an Internal Audit Program as defined by QSOP for this purpose Product Realization Process and Product Conformance Measurements of the Product Realization Process and Product Conformance will be utilized to consider the impact each process has on the overall effectiveness of the Quality Management System and the impact it has on its ability to meet product requirements. They will be carried out in accordance with Section 7.0 and the documentation referenced therein. These measurements may also be utilized in monitoring factors of Customer Satisfaction and Quality System Conformance and Performance. If so, it will be defined in the QSOP s referenced in the preceding sections First Article Inspections are performed when required by the customer. This requirement is treated no differently than any other customer requirement and is assured via the processes defined by Section 7.0. In instances where design or development activities (typically First Article Inspection) is required by the customer order, specific requirements will be documented by the order and the quality planning for the order will include the necessary design and development controls for meeting those requirements including requirements of AS9102 (Ref. QSOP 7.2-1). 8.3 Control of Non-Conforming Product WireMasters has established and operates documented procedures to assure that product which does not conform to customer, regulatory and internal requirements is identified and controlled to prevent its unintended use. These documented procedures and the associated responsibilities, controls and documentation are defined in QSOP Page 19 of 20

20 8.4 Analysis of Data WireMasters performs analysis of data at various levels from the monitoring and measurement described above for purposes of assessing the ongoing performance and effectiveness of the Quality Management System, and for taking appropriate action. The procedures, responsibilities, frequency and timing, for this analysis are included within in the previously referenced QSOP s. 8.5 Improvement WireMasters has established structures and mechanisms for taking appropriate action based on the various monitoring, performance measurement and analysis defined in this Manual. These address three basic aspects of Quality Management System action: Continuous Improvement QSOP establishes the structure, mechanisms, responsibilities, procedure and controls for taking action on identified opportunities in order to reduce the risk of product nonconformances, and to improve the effectiveness of the Quality Management System in providing value. It includes the prioritization, planning and management of improvement projects Corrective Action QSOP establishes the structure, mechanisms, responsibilities, procedure and controls for taking action on non-conformances identified in product, process or any aspect of the Quality Management System. It covers the remedial action necessary to correct the nonconformance, and the identification and removal of the root cause of the nonconformance to prevent recurrence; in addition to reviewing the effectiveness of the corrective action taken Preventive Action QSOP establishes the structure, mechanisms, responsibilities, procedure and controls for continuing process which improves the quality system and processes throughout the company and therefore attempts to prevent Corrective Action from being necessary. These processes can be identified in product, process or any aspect of the Quality Management System. It covers the remedial action necessary in determining potential non-conformances and their causes; in addition to reviewing the effectiveness of the preventive action taken. Page 20 of 20

21 WireMasters Organizational Chart To view the WireMasters organizational chart, click here