ABTREX INDUSTRIES, INC. QUALITY MANAGEMENT SYSTEM MANUAL

Transcription

1 ABTREX INDUSTRIES, INC. QUALITY MANAGEMENT SYSTEM MANUAL Project Quality Management System Status APPROVED Approved by KB Keith Byars, Vice President Owner KC Kevin Couvillion, Operations Manager Author CRG Charles Groom Contributors KC Kevin Couvillion AP Anna Pedzinski, Office Manager

2 Contents /17/11 1 of 1 MSM Section Contents ISO 9001 Ref. 0.0 Contents 0.1 Quality Policy Statement System Scope 0.3 Process Interaction Flow Business and Resource Planning 5.0, 6.0, 8.2.3, 8.4, Sales and Quoting 7.1, 7.2, Project Management 7.1, 7.2, Design 7.2, Purchasing Manufacturing 7.5, 8.2.4, Installation and Servicing 7.5, 8.2.4, Equipment Maintenance and Calibration 6.3, Training Internal Audits 8.2.2, 8.2.3, Continual Improvement Document and Record Control 4.0 Appendix A Records Table 4.2.4

3 Quality Policy Statement /17/11 1 of 1 Abtrex Industries is committed to: Providing linings and coatings that meet or exceed our customers expectations for quality, conformance and timeliness Establishing and maintaining an effective Management System based on ISO 9001 Involvement of every employee in the continual improvement of our systems and our overall quality goals To ensure continual improvement, Abtrex Industries management reviews the effectiveness of the management system during regular scheduled meetings.

4 System Scope /17/11 1 of 1 This Management System Manual addresses all applicable requirements of ISO 9001:2008 for the following: Exclusions Abtrex Industries, Inc Market St. South Bend, IN Based on the nature of our business there are no exclusions to ISO 9001:2008

5 Process Interaction Flow /17/11 1 of 1 Start Business Planning Business and Resource Planning MSM 1.0 Continual Improvement MSM 11.0 Training MSM 9.0 Document & Record Control MSM 12.0 Analysis of Data Business and Resource Planning MSM 1.0 Continual Improvement MSM 11.0 Project Management MSM 3.0 Customers Sales and Quoting MSM 2.0 Project Management MSM 3.0 Field Work & Servicing MSM 7.0 Design MSM 4.0 Production and Measurement Project Management MSM 3.0 Planning Design MSM 4.0 Purchasing MSM 5.0 Equipment Maintenance & Calibration MSM 08 Manufacturing MSM 6.0 Purchasing MSM 5.0 Field & Servicing MSM 7.0 Project Management MSM 3.0 Sales and Quoting MSM 2.0 Document & Record Control MSM 12.0 Internal Audits MSM 10.0

6 Business and Resource Planning of Purpose This procedure describes the processes used for business planning and setting of business objectives, to support the overall management system with management review meetings and communication of management system related information, including the importance of meeting customer, statutory and regulatory requirement, and the planning and provisioning of the needed business resources. 2.0 Responsibilities Abtrex has established Job Descriptions for each position in the company. For the purposes of this quality manual the following positions are noted. The Vice President is responsible for approval of the organization s quality policy, and ensuring that business objectives are established The Operations Manager is responsible for ensuring evidence of its commitment to the development and improvement of the Management System, and coordinating the management review meetings and following up on assigned action items. The Management Team is responsible for ensuring that customer needs and expectations are determined, converted into requirements and fulfilled with the aim of achieving customer satisfaction, ensuring that resources needed to achieve the business objectives are identified and planned, supporting the establishment and maintenance of the Management System and communication of Management System processes to all employees, and attending management review and communication meetings, providing results and taking action to improve the Management System, when appropriate.

7 Business and Resource Planning of 4 The management team at Abtrex consists of the following positions: Vice President Operations Manager Sales Engineers Shop Forman Office Manager 3.0 Procedure Business Planning and Objectives During the business planning process, the Vice President, with input from the Operations Manager, determines the organization s Goals and Objectives. The business objectives are measurable and consistent with the Policy Statement. Data is collected quarterly in support of the goals and objectives as Monthly Measurements. The Management reviews the results of the measurements during management review meetings per the Management Review Agenda Matrix. Management Review The Management Team reviews the Quality Management System at a minimum or twice per calendar year per the Management Review Meeting Agenda to ensure its continuing suitability, adequacy and effectiveness. The reviews assess opportunities for improvement and evaluate the need for changes to the organization s Management System. The minutes from these meetings include: any decisions made, action items related to the improvement of the effectiveness of the Management System and its processes, action items related to the improvement of product related to requirements, identification and provision of resources to support completion of assigned actions, and target or planned completion dates.

8 Business and Resource Planning of 4 Management System Support and Communication The Management Team provides evidence of its commitment to the development and improvement of the Quality Management System. The following shows this commitment: a) holding scheduled meetings with the employees to discuss the importance of meeting customer and operational requirements; b) conducting management review meetings; c) ensuring the availability of necessary resources Management Representative The Operations Manager has been appointed the Management Representative. This function is responsible for supporting team, to ensure that the Quality Management System processes are established, implemented and maintained. This function acts as the liaison for internal and external parties who inquire about Abtrex Industries management system and associated documentation. Provision of Resources Management, during management review meetings determines the personnel needed to implement, maintain and continually improve the effectiveness of the Quality Management System and to enhance customer satisfaction by meeting customer requirements. Actions are assigned and carried out as a result of this determination. Infrastructure Management determines, provides, and assigns actions to ensure the infrastructure needed to achieve of the conformity of product. This identification process includes an evaluation of buildings, workspace and associated utilities; process equipment, hardware, and software; and supporting services such as transportation or communication. Work Environment The organization determines and manages the work environment needed to achieve conformity of product. Actions are identified, when appropriate, to correct deficiencies in the work environment.

9 Business and Resource Planning of 4 All employees are encouraged to make suggestions for improvement through the use of the Continual Improvement Form (CIF). 4.0 Related Documentation Policy Statement CIF Monthly Measurement Summary Management Review Agenda Matrix Management Review Minutes/Actions 5.0 Revision History Revision Date Revision Details Initial Release

10 Sales and Quoting of Purpose This section describes the sales and quoting processes. 2.0 Responsibilities/Authorities The Management Team is responsible for receiving requests for quotes, preparing quotes and providing them to customers. The Vice President is responsible for monitoring customer satisfaction and dissatisfaction and other indicators of the operations that are necessary to meet customer requirements and business goals and objectives. 3.0 Process/Procedure Responding to Request for Quote When a request for quote is received, it is reviewed to ensure that Abtrex Industries can meet the customer requirements, and fully understands any new or additional statutory or regulatory requirements. If it is determined that Abtrex Industries can not meet the defined requirements, the customer is notified that Abtrex Industries has declined the RFQ, with reason(s) noted. If Abtrex Industries can meet the customer requirements, typically a quote is prepared and submitted to the customer. If the job is repair work, or a service visit, the quote may be generated and submitted after the customer request/equipment has been received or reviewed. Quotes, supporting quote information and records of the results of the review and actions arising from the review are maintained per the Records Table.

11 Sales and Quoting of 6 Responding to Requests for Quote Opportunity The Management Team Receive request for quote (RFQ) The Management Team Review requirements The Management Team The Management Team Contact Customer with No Quote decision No The Management Team Quote or No Quote Yes Review Team Requirements acceptable & understood? The Management Team Contact customer or internal departments for clarification No Maintain quote documentation as a record The Management Team Forward quote to customer The Management Team Prepares Quote Yes

12 Sales and Quoting of 6 Order/Amendment Review and Entry Process Upon receipt of the customer s order, verbal or written, it is reviewed. Often, requirements such as delivery are not addressed in the quotation; if it hasn t been addressed in the quotation, it is addressed when the order is received. Once the requirements are determined and agreed upon, the order is processed and scheduled for all stages (i.e. design, production, and installation as appropriate). A copy of the PO or agreed order requirements is forwarded to Accounting. The Management Team Pull quote and compare to the order The Management Team Order Acceptance/ Amendment Process The Management Team Customer changes to existing order received Does the order meet the quote? Yes The Management Team No The Management Team Are the new requirements acceptable? No The Management Team Contact with customer and internal departments, as necessary The Management Team Assign Project Manager if appropriate or Initiate Work Order Can we meet the delivery requirements, etcetera? Yes Yes The Management Team Process order within the system The Management Team Adjust order as necessary

13 Sales and Quoting of 6 Customer Communication Management and/or the assigned project manager determines and implements effective arrangements for communication with customers relating to inquiries, contracts, change orders, status meetings and customer feedback. Responding to Customer Feedback Management continually monitors information on customer perception as to whether Abtrex Industries has fulfilled customer requirements as one of the measurements of performance. Management measures customer satisfaction and dissatisfaction indicators for inclusion in the monthly measurements. These indicators include on-time delivery performance and customer complaints. Any employee should report customer dissatisfaction or complaints using the Continual Improvement Form (CIF) process. Data from the CIF process is evaluated during the Management Review.

14 Sales and Quoting of 6 Responding to Customer Feedback Processes Customer-related Objectives The Management Team Customer Feedback process at a minimum annually The Management Team Evaluation of customer-related objectives Management Management Positive Results back? No Contact customers as necessary Customer Feedback Yes Management Negative Management Summarize and analyze data Other customer feedback received? Negative Positive Management Discuss/Plan at Management Review Meeting Management Initiate CIF process

15 Sales and Quoting of 6 Service to the Customer Confidence of our customers and assisting their needs are critical to Abtrex Industries. To address these concerns, we place a high value on working with our customers to maintain communication and assistance throughout the contract cycle. This is done by: Providing technical advice and guidance when appropriate, Providing project status, when appropriate, Documenting and addressing feedback from the client, Assisting in verification activities. 4.0 Related Documentation MSM 3.0 Project Management MSM 4.0 Design MSM 6.0 Manufacturing MSM 7.0 Installation CIF Customer Contracts/PO Management Review Minutes 5.0 Revision History Revision Date Revision Details 07/10/12 Initial Release

16 Project Management of Purpose This procedure defines the activities associated with Project Management in support of effective planning, implementation and reporting of project information against the customer contract. Project Management is used for projects based on their manufacture/installation duration and/or quoted project duration of more than one month (not including material lead times). 2.0 Responsibilities Operations Manager has overall responsibility for the Project Management function, including activity prioritization and resource allocation. In most cases the Sales Engineers are appointed as the Project Managers Assigned Project Managers/Sales Engineer Primary contact with the customer. Document and maintain the project schedule Support the coordination of customer interactions, facilitate meetings, and ensure project specific information is available and shared across all functional areas. Support vendor communications and ensure conformance to delivery requirements and project deadlines. Gather and communicate job/project metrics, and Report to management on overall project performance. 3.0 Procedure Project Plan A project schedule is generated for each project at its acceptance. The schedule outlines the project timing, the key deliverables and the key milestone activities with associated responsibilities.

17 Project Management of 3 Project Information The Job File is used to store and share project information. The following is a list of the minimum information found in the project file: Project Schedule Customer Requirements Documentation (PO, Contract, Specifications) Design Information Vendor Contracts/POs Customer Meeting Minutes Copies of any CIFs associated with the Project Warranty Information/Terms Project Management Meeting Facilitation Meetings are scheduled, as required at key phases of the project, based upon the overall Project Schedule. All formal meetings are documented using the Meeting Minutes Form as applicable. Any associated action items are forwarded to the appropriate individuals. It the responsibility of the project manager to ensure all action items are completed based upon the defined requirements and associated deadlines. Project Amendments/Changes Formal updates or changes to the agreed upon customer contract or timeline, must be documented and processed as order amendments per the Sales and Quoting Process (MSM 2.0)

18 Project Management of Related Documents Project Schedule Meeting Minutes Form CIF Project Job File MSM 2.0 Sales and Quoting MSM 4.0 Design MSM 5.0 Purchasing MSM 6.0 Manufacturing MSM 7.0 Service and Installation 5.0 Revision History Revision Date Revision Details Initial Release

19 Management System Manual 4.0 Title: Design 1 of Purpose This Management System Manual (MSM) Section describes procedures and documents used to plan and control design and development activities for products. 2.0 Responsibilities The Operations Manager has responsibility for the control and implementation of the design process and associated activities. The Project Managers are responsible for interfacing with customers to determine the design requirements. 3.0 Procedure Design and Development Planning The Operations Manager manages the design and development activities. Design projects are reviewed during management review meetings. A Design Checklist is initiated for each design project to identify the required design activities based on the scope of the overall project. The Checklist includes activities, as appropriate, to support review, verification and validation at each design stage. Design and Development Inputs Design and development input requirements are determined and recorded at the start of a project. Incomplete, ambiguous, or conflicting requirements are reviewed/resolved with the customer. Design and Development Outputs Outputs are reviewed to ensure they meet input and customer requirements (the Drawing Submittal Form may be used), provide appropriate information for purchasing, manufacturing and field service provisions, contain or reference

20 Management System Manual 4.0 Title: Design 2 of 5 acceptance criteria and specify the characteristics of the product. (See Design Checklist.) Design and Development Review The Project Manager is responsible to ensure at least one formal review of the design at a suitable stage of the project. (See Design Checklist) This review evaluates the ability of the outputs to fulfill the requirements. Records of reviews and subsequent follow-up actions are recorded and maintained in the Project File. Design and Development Verification Design and development verification activities are performed to ensure that output have satisfied inputs and can include, but are not limited to: drawing and CAD review, customer specification comparison, comparison of new design to existing proven design, and performance testing The results of the verification activities and subsequent follow-up actions are recorded and maintained in the Project File. Design and Development Validation Design validation is normally performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting requirements for the intended use. Whenever applicable, validation is completed prior to the delivery or implementation of the product. If necessary, the validation process makes use of field service reports. When design services are outsourced, the organization maintains responsibility for the subcontracted services. The results of the validation activities and subsequent follow-up actions are recorded and maintained in the Project File.

21 Management System Manual 4.0 Title: Design 3 of 5 Control of Design and Development Changes Design and development changes are identified, documented and controlled. The changes are verified and validated prior to implementation. The results of the review of changes and subsequent follow-up actions are recorded and maintained in the Project File.

22 Management System Manual 4.0 Title: Design 4 of 5 MSM 2.0 Sales Process Design & Development of Product Project Manager Customer Design Requirements are viewed. Project Manager Project File Started and Design Checklist is initated Project Manager Inputs are reviewed No Inputs are clear Yes Project Manager D&D Inputs are documented in the Project File Project Manager Verification results are documented in the Project File Operations Manager Outputs are documented Project Manager Rejected Job is complete and enters warranty period Accepted Project Outputs Mana are reviewed. Project Manager Project Manager Design Review Records are maintained in the Project File Approved Project Manager Output documents are approved and released D&D Project Pr is Validated Rejected Project Manager Project Manager Validation subsequent actions are documented in Project Book MSM 6.0 Manufacturing Process Action Item list is initiated and all modifications are implemented or concessions documented.

23 Management System Manual Related Documentation Title: Design 5 of 5 Project File Meeting Minutes Form Design Checklist MSM 1.0 Business and Resource Planning MSM 2.0 Sales MSM 3.0 Project Management MSM 5.0 Purchasing MSM 6.0 Manufacturing MSM 7.0 Service and Installation 5.0 Revision History Revision Date Revision Details Initial Release

24 Purchasing of Purpose This Management System Manual (MSM) Section describes the processes used for Vendor selection, evaluation and purchasing. 2.0 Responsibilities/Authorities The Operations Manager is responsible for approving Vendors and tracking Vendor performance. The Office Manager is responsible for processing purchase orders. Project Managers are responsible for placing project-specific purchase orders. The Shop Forman is responsible for verifying that received product/material meets purchasing requirements and for reporting Vendor performance issues to the Office Manager or Operations Manager. 3.0 Process/Procedure Vendor Qualification and Evaluation Abtrex Industries ensures that purchased product conforms to specific purchase requirements. The type and extent of control of the Vendor and purchased product is dependent upon the effect on subsequent realization processes and their output. Current Vendors of materials and services as of are approved based on past performance. Vendors are evaluated and selected based on their ability to supply product in accordance with our requirements. Initial use of the Vendor and their performance determines if the Vendor is suitable. The use of customer-specified Vendors does not release Abtrex Industries from the responsibility of ensuring the quality of the purchased product/service. Vendor performance is periodically evaluated and the results of these evaluations and any needed actions are discussed at management review and may be documented using a CIF that is issued to the Vendor for response.

25 Purchasing of 5 Purchasing Information Project Specific Material Quotes/Purchasing Request for quote sheets are sent to Vendors during the quoting phase for a customer project when pricing is not pre established. The sheets are submitted to the defined vendors for quote. Based on the quotes received, a vendor is selected. A Purchase Order Form is generated and submitted to the vendor. The completed PO form is then forwarded to the Office Manager to be entered into the accounting system. If the purchasing requirements are not complete, the Office Manager returns quote information to the Operations Manager or issuer for completion before processing. Acknowledgments, if received, from vendors agreeing to the order requirements are reviewed and attached to the Purchase Order and filed. Amendments to Purchase Orders are processed for an open order when there is a change or addition in the items, quantity, price, or delivery. Amendments go through the same review and approval process as the original order. If vendors do not meet the Purchase Order requirements (e.g. price, quantity, quality, or on-time delivery), the Office Manager may issue the vendor a Continual Improvement Form or make a note of the discrepancy on the purchasing documents in the vendor file. If Vendors consistently do not meet the Purchase Order requirements, Management may decide to terminate the vendor relationship. General Supply Purchasing A hardcopy Purchase Order form is generated that clearly defines the products or services to be ordered and the vendor to be used. The completed PO form is then forwarded to the Office Manager to be entered into the accounting system.

26 Purchasing of 5 Verification of Purchased Product Abtrex Industries performs inspection or other activities necessary, ensuring that purchased product meets specified purchase requirements.

27 Purchasing of 5 Receive a Vendor Sheet or Hard Copy PO Is the requisition/ material available with an approved vendor? No Project Manager select a vendor Yes No Purchase Information complete and vendor approved? Yes Issue Purchase Order to vendor Raw Material Receive the material, check the shipper for size, quantity and type of material. Stock Items Checks the content and quantity on the packing slip. Purchase delivered on time? No Document Performance Issue on Vendor Paperwork and/or CIF Service Items Verify that the service was performed adequately per the PO. Yes Receipts that meet the purchasing requirements are signed off and Paperwork is given to the Office Manager. Purchase product/ service acceptable? No Receipts that have issue the issue is noted on the vendor paperwork and the Operations Manager or Office Manager is notified immediately. Yes Received Vendor Paperwork is forwarded to Office Manager Upon Receipt Raw Material and Stock Items are identified with appropriate Project Number, if applicable and placed in inventory or designated storage location.

28 Purchasing of Related Documentation CIF Peachtree Accounting Software Purchase Order Form Vendor File Vendor Packing List/Shipper 5.0 Revision History Revision Date Revision Details Initial Release

29 Management System Manual 6.0 Title: Manufacturing 1 of Purpose This Management System Manual (MSM) Section describes the processes used to control production and repair operations. 2.0 Responsibilities The Operations Manager has responsibility for manufacturing operations, identification of products, and preservation of products and control of customer property. Production personnel are responsible for processing work orders/jobs per the order requirements. 3.0 Process/Procedure Control of Production The organization carries out production activities which may include any or all of the following under controlled conditions: Welding Metal and/or Plastic, Cutting/Sawing, Drilling, Sandblasting, Assembly, Piping, Lining/Coating/Painting, and Shipping and Receiving Production and service operations are documented on a Work Order to cover at a minimum the following things: Equipment Needed Personnel/Competency Needed (as applicable) Inspection Points Acceptance Criteria Monitoring/Measuring Devices Needed

30 Management System Manual 6.0 Process Qualification Title: Manufacturing 2 of 4 Abtrex Industries utilizes qualified personnel that are certified against industry standards for any welding operations that are conducted. Records are maintained to support this process. Inventory Controls Most materials are ordered specific for job requirements and are received, stored and identified with the job on the floor until processed. Standard materials are stored in designated inventory locations until needed. Storage areas ensure proper preservation of these materials. Inspection and Test Required inspection and test activities are carried out based on the work order/job package information at defined process steps. When all processes are completed, the Project Manager (who is the authority responsible for the release of product) verifies that customer requirements are met and indicates the job is released for shipment. Jobs are not released for delivery until all the specified activities have been satisfactorily completed, unless otherwise approved by the customer or Abtrex management. Control of Nonconforming Product Jobs and/or materials, which do not conform to requirements, are identified and controlled to prevent unintended use or delivery. Nonconforming raw material, work in process or finished jobs are tagged from the time it is identified until it is dispositioned.

31 Management System Manual 6.0 Title: Manufacturing 3 of 4 One or more of the following is an expectable disposition: Returned to the supplier, Reworked or adjusted to meet the customer requirements, Scrapped, or Accepted, with or without rework, by customer deviation. Reworked or adjusted material is re-inspected according to the original order requirements. When suspect or nonconforming material or equipment is detected after delivery to the customer, Abtrex Industries initiates the Continual Improvement process by documenting the occurrence with a CIF. Job Identification and Traceability Work Order numbers are used to identify jobs at all stages from receipt thru ready for delivery. The status of the product with respect to measuring and monitoring requirements is identified on the associated tag, or the job package/work order information. Customer Property Abtrex Industries exercises care with customer property while it is under our control or being used by us. Abtrex identifies, verifies, protects, and maintains customer property provided for repair, use or incorporation into our final product. Any customer property that is lost, damaged or otherwise found to be unsuitable for use is reported to the customer by the Project or Operations Manager and disposition is noted in the job file. Customer is notified via , fax or other written correspondence. Work Order Completion/Storage/Shipping Abtrex Industries ensures that jobs are packaged to safeguard the product until it is delivered or picked up by the customer. After packaging, shipping containers are labeled according to customer and internal requirements found on the shipper.

32 Management System Manual Related Documents Title: Manufacturing 4 of 4 Work Order/Job Package Information Work Orders CIF Job Files Shipper/Packing List Customer Shippers 5.0 Revision History Revision Date Revision Details Initial Release

33 Management System Manual 7.0 Title: Installation and Servicing 1 of Purpose This Management System Manual (MSM) Section describes the processes used to control product installation and onsite service calls at customer locations. 2.0 Responsibilities The Project Manager has responsibility for all field jobs and customer service calls. The Project Manager is responsible for working with the Plant Forman to assign Technicians to customer service calls and field projects. Technicians are responsible for processing work orders/job tickets or Service Calls per the order requirements. 3.0 Process/Procedure Field Work When applicable, a Technician, who is qualified for the specific project, performs job using specific equipment and tooling designed for a successful project. After project is complete, the Technician completes a Work Order indicating what activities were performed and what materials were used. Form is returned to the Project Manager for review. Copies of the Work Orders are filed with the applicable system Job File. Any changes to As Built engineering drawings are noted or marked-up by the Technician. The drawings are returned for drawings revision. Service Calls All customer requests for service are reviewed by the Project Manager and documented on Work Orders. The Project Manager with input from the Plant Manager assigns personnel to handle the request. The assigned personnel, as appropriate, respond to customer requests at the customer s location.

34 Management System Manual 7.0 Title: Installation and Servicing 2 of 3 The Technician performs an initial inspection to determine if the repair is covered under the customer s warranty. If the repair is a warranty item, then failure of the product is noted on the Work Order for review by the Operations Manager and/or the Vice President. If the repair is a service item not covered under warranty the Technician performs the required repairs and documents the work performed on the Work Order. Once the assignment has been completed, the assigned personnel complete the Work Order indicating what activities were performed, and obtain the customer s approval signature on the appropriate line of the form. Completed Work Orders are returned to the Project Manager for review and analysis. If any service concerns or nonconforming supplier product are detected in the maintenance history of equipment, corrective action is initiated and tracked to completion via the CIF System. Copies of the Work Orders are filed with the applicable system Job File. Any changes to As Built engineering drawings are noted or marked-up by the Technician. The drawings are returned for drawings revision. Suspect or Nonconforming Product If the Technician believes that the equipment is defective and/or is suspect and could be a problem that should have been resolved by Abtrex Industries, the Project Manager and/or the Operations Manager is contacted for disposition. When suspect or nonconforming material or equipment is detected after delivery to the customer, Abtrex Industries initiates the Continual Improvement process by documenting the occurrence with a CIF. 4.0 Related Documents MSM 2.0 Sales MSM 3.0 Project Management MSM 11.0 Continual Improvement Work Order Job Files CIF

35 Management System Manual 7.0 Title: Installation and Servicing 3 of Revision History Revision Date Revision Details Initial Release

36 Equipment Maintenance and Calibration of Purpose This Management System Manual procedure describes the process used to manage equipment maintenance activities and the control of inspection and measurement equipment. 2.0 Responsibilities The Shop Forman is responsible for: determining the maintenance requirements for production equipment identifying the inspection and measurement equipment that are critical to the manufacturing process and implementing a calibration system for critical equipment, assuring that the environmental conditions are appropriate for performing calibrations, inspections, and tests. The Project Manager is responsible for notifying the customer if suspect product has been shipped due to Inspection and Test Equipment being out of calibration/verification. Employees are responsible for: using only calibrated equipment for required inspections and tests handling and storing equipment in a way that maintains its accuracy and fitness for use 3.0 Procedure Equipment Maintenance Abtrex Industries ensures the maintenance of equipment for production operations through the use of a Preventive Maintenance (PM) process. The preventive maintenance system includes: planned maintenance activities for defined manufacturing equipment, packaging and preservation of equipment, tooling and gauging availability of replacement parts

37 Equipment Maintenance and Calibration of 3 Production personnel perform PM according to the equipment manufacturers reference manuals, work instructions and the PM Schedule, as appropriate. Records for the PM activities are filed per the Records Table. Inspection and Test Equipment Verification/Calibration Abtrex identifies the inspection and measuring equipment that requires verification to assure conformity of product to specified requirements. Equipment is used and controlled to ensure that measurement capability is consistent with the measurement requirements. Inspection and test equipment is verified and/or calibrated either in house using traceable masters and defined work instructions, or by qualified suppliers. The frequency of calibration/verification is determined based on calibration/verification history, testing or inspection method, severity of environment, frequency of usage, and the required accuracy of the measurement, as appropriate. Frequencies are defined on the Calibration Schedule. Inspection and test equipment is uniquely identified by a sticker or permanently etched and an individual calibration/verification record is established. The status of calibration/verification is either on a sticker attached to the equipment or is found in the appropriate calibration/verification record. When calibration/verifications are due, the Plant Manager either arranges for the calibration by a supplier or internal verification. Records of as-found measurements, the condition of the equipment, and any adjustments made are in the Calibration Records. The Plant Manager reviews the verification/calibration record to for the as-found condition and its effect on previously inspected and tested product since the last acceptable calibration/verification. If it is determined that there is suspect nonconforming material is still under our control, or suspected material has been shipped, our Manufacturing or Service/Field Work process is followed to support the control of nonconforming product. After calibration/verification, equipment is safeguarded from adjustments that would invalidate the calibration/verification.

38 Equipment Maintenance and Calibration of Related Documentation Calibration Schedule Calibration Work Instructions Calibration Records MSM Appendix A - Records Table PM Schedule PM Records 5.0 Revision History Revision Date Revision Details Initial release

39 Training of Purpose This Management System Manual (MSM) Section describes the process used for the assignment and training of employees that support the operation of the Management System. 2.0 Responsibilities/Authorities The Management Team is responsible for ensuring that employees who are assigned responsibilities within the Management System are competent and for providing training for employees, when applicable. The Management Team is responsible for new hire orientation and maintaining individual employee training records. The Management Team responsible for evaluating training effectiveness and maintaining training records. 3.0 Process/Procedure Abtrex Industries policy is to employ competently trained or experienced employees. This is achieved by a comprehensive recruitment and selection procedure, supplemented by on-the-job training. Competence, Awareness and Training 1) A Training Matrix is used to document employee required skills/knowledge and track the implementation or achievement of the skill set. 2) Management uses the Training Matrix to assess, at least annually, the training needs and training effectiveness for new and existing employees. 3) Management is responsible for ensuring that employees and contract personnel receive appropriate on-the-job training in new or modified jobs and are informed of the impact of nonconforming product/services to the customer. Employees are evaluated on their awareness of relevant activities and their impact on meeting the established quality objects during Internal Audits and the results are included in the management reviews.

40 Training of 3 New Employee or New Skill Set Need identified Department Foreman Does employee meet competency requirements Yes Department Foreman Provide initial organization orientation training Training includes: Quality Policy, MSM, WI, Forms & How employee contributes to the overall business goals/objectives No Department Foreman Department Foreman Identify and document training/skill needs Complete new hire paperwork, maintain as record Department Foreman Provide Training Department Foreman Maintain training / skills records (Update Training Matrix) Yes Department Foreman Was the training effective? No Department Foreman Take Appropriate Actions Inputs: Internal Audits Management Review Management Observation

41 Training of Related Documents Training Matrix New Hire Orientation Checklist Management Review Minutes MSM Appendix A - Record Table 5.0 Revision History Revision Date Revision Details Initial Release

42 Management System Manual 10.0 Title: Internal Audit 1 of Purpose This Management System Manual (MSM) Section describes internal audit process. 2.0 Responsibilities/Authorities The Management Representative has overall responsibility for the Internal Audit process which includes: Developing and maintaining an internal audit schedule based on status and importance Assuring that internal auditors are trained in ISO 9001 and ISO Assuring that all audits are carried out independently Internal audits may be carried out by internal employees or external contracted auditors as required 3.0 Process/Procedure Internal audits are held to determine: whether the Management System conforms to the requirements of ISO 9001 and any additional organization Management System requirements, whether the manufacturing processes are effective, whether products/services, at appropriate stages of production and delivery, conform to specified requirements, and whether the Management System has been effectively implemented and maintained. The frequency of audits may change due to internal/external nonconformities and audit results, and customer complaints. At a minimum, the audit schedule will be reviewed and updated annually. Audit checklist are developed as needed by the auditor

43 Management System Manual 10.0 Title: Internal Audit 2 of 3 Internal Audits Management Representative Create annual audit schedule Internal Auditor Auditor Qualification Records Management Representative Determine auditors Internal Auditor Arrange audit with area manager/ supervisor Internal Auditor Prepare for audit Internal Auditor Perform audit; document objective evidence Internal Auditor Audit Questions/ Marked Up QMS Sections Internal Auditor Identify nonconformance's Internal Auditor Fill out CIFs and Audit Summary Report Internal Auditor Forward Audit Summary Report and CIFs to MR Management Representative Review completed audit Internal Auditor Verify closeout of audit findings Management Representative Schedule re-audit if necessary Management Representative Review audit results at Management Review Meetings

44 Management System Manual Related Documents Title: Internal Audit 3 of 3 MSM 1.0 Business and Resource Planning MSM 11.0 Continual Improvement CIF Audit Summary Report Audit Schedule Management Review Minutes MSM Appendix A - Record Table 5.0 Revision History Revision Date Revision Details Initial release

45 Continual Improvement of Purpose This Management System Manual (MSM) Section describes the process used by Abtrex Industries to ensure corrective action, preventive action and continual improvement to the management system and our business process improvement. 2.0 Responsibilities/Authorities The Management Team is responsible for planning and managing processes necessary for continual improvement, reviewing trends and assigning resources to support continual improvement efforts. The Management Representative has overall responsibility for the CIF (Continual Improvement Form) process. Employees are responsible for initiating CIFs as necessary. The Management Representative and Internal Auditors are responsible for determining if CIFs are closed out, and if the closeout is effective 3.0 Process/Procedure Continual Improvement Abtrex Industries continually improves the effectiveness of the Management System through the use of: the Quality Policy Statement, Business Objectives and Goals, Audit Results, Analysis of Data, Corrective and Preventive Action, and Management Review. Continual Improvement Projects/Initiatives are implemented where appropriate. They are identified at Management Review and required activities, responsible personnel and status of activities are recorded in the meeting minutes.

46 Continual Improvement of 5 Continual Improvement Management Team Determination that Improvement is needed Management Team Determine Project Owner Process Owner Outline Improvement Project and firm up Objectives Process Owner Identify solutions and determine the best Process Owner Implement solution Process Owner No Did this solution meet our objective? Yes Process Owner Update system documentation and look at similar processes for preventive opportunities Process Owner Report Project Status at Management Review Meetings

47 Continual Improvement of 5 Corrective / Preventive Action Process The Continual Improvement Form (CIF) is used to identify and eliminate root causes of corrective and preventive actions. Corrective actions are analyzed for applicability to other similar processes and/or products. Where applicable, the corrective action resolutions are applied and implemented to those processes to eliminate the potential nonconformity. The impact of corrective actions is considered to ensure that the implementation of solutions does not adversely affect stable or capable systems. Abtrex Industries analyzes customer rejected or returned products in a timely manner. The Continual Improvement process is initiated and corrective action is taken, for all customer-rejects, returns or complaints. Customer nonconformance is addressed in the customer-prescribed format using the customer s form, if required. CIFs are maintained per MSM Appendix A, Records Table.

48 Continual Improvement of 5 Corrective / Preventive Action Need can include: audit findings, customer complaints, supplier problems, nonconforming products, nonconforming process, preventive action, maintenance problems, and employee suggestions CIF Originator Need is identified CIF Originator A Continual Improvement Form (CIF) is initiated CIF Originator Management Representative Return to initiator for revision / clarification No Forward CIF to Management Representative (MR) Management Representative Is CIF valid? Management Representative Report on CIF trends and any corrective / preventive action to Management Review Management Representative CIF Log is updated Yes Management Representative CIF is assigned and logged into CIF Log MR s Designee Document results of corrective / preventive action on the CIF Yes CIF Champion Assignee determines root cause and corrective / preventive action CIF Champion Implement corrective action / Update systems No MR s Designee Is corrective / preventive action effective? (follow up) Management Representative CIF Champion Complete the CIF and return to MR No CIF Log is updated Yes MR s Designee Corrective / preventive action in place? (follow up)

49 Continual Improvement of Related Documents MSM 10.0 Internal Audit Process CIF CIF Log Management Review Minutes MSM Appendix A - Record Table 5.0 Revision History Revision Date Revision Details Initial release

50 Management System Manual 12.0 Title: Document and Record Control 1 of Purpose This Management System Manual (MSM) Section describes the structure of the Management System and how we control documents. 2.0 Responsibilities/Authorities The Management Representative (MR) is responsible for the establishment, maintenance, control, issue and changes to the Management System documents and records. The Operations Manager is responsible for the control of customer and organization drawings and specifications. The Office Manager is responsible for the control of electronic documents and data. Designated employees/functional areas may be responsible for the control of records if deemed necessary by the MR. 3.0 Process/Procedure Management System Manual This MSM is established and maintained in compliance with ISO 9001, and to define the operational processes/procedures that support the business activities at Abtrex Industries. The MSM is controlled to ensure that up-to-date documentation is available to our employees. Control of Documents All Management System documents are approved for adequacy by designated employees prior to issue and are identified with a current revision status. Electronic documentation is maintained on the company network and is accessible to all employees in a read-only format and maintained by the Management Representative and/or designee. Documents on the network are approved and up-to-date based on their inherent nature. Hardcopy documents may be printed for use, but are not controlled. Any employee can propose Management System document changes by using the Continual Improvement Form (CIF) or by submitting a proposed changed document to the document owner. Recommendations for changes are

51 Management System Manual 12.0 Title: Document and Record Control 2 of 5 forwarded to the MR. Changes to documents are identified by revision date and letter (A, B, C, etc.) or may have revision history box used to describe changes. A Master Document List is maintained to identify the controlled management system documentation, ownership and location. The MR periodically reviews Management System documents to ensure that they are legible and readily identifiable. To support the control of electronic documents and data used within the Management System, the files are automatically backed up on a regular basis to a network-attached external hard drive. The Document Control processes are described in the attached Flow Charts. Engineering Documents The Operations Manager is also responsible for maintaining customer drawings and specifications. This file contains the master set of drawings and/or associated electronic CAD data. Documents referenced on the customer s drawings and specifications are maintained in our facility and are kept at the latest release level spelled out on our customers purchase orders. (Reference the Master Document List External Documents) Control of Records The Records Table indicates records required for the Management System (reference MSM Appendix A, Records Table). These records are legible, readily identifiable and retrievable and are maintained to provide evidence of conformance to requirements and the effective operation of the Management System.

52 Management System Manual 12.0 Document Control Flow Title: Document and Record Control 3 of 5 No Need for a document is determined Management Representative Determine document champion Document Champion Create/modify document(s) Document Champion or Management Representative Review and approve document(s) Yes Management Representative Have placed on network as Read Only Management Representative Update Master Document List Process Owner(s) Notify, Train employees Document Champion or Management Representative Is document acceptable?

53 Management System Manual 12.0 External Document Control Title: Document and Record Control 4 of 5 External Document Control Document Receiver External Document is received MR Review documents for content MR Contact receiver or issuing organization about reason for document No MR Does the document impact the organization? Yes MR Dispose of the Document Yes MR Do we already have a copy of this revision? No MR Update customer Folder and/or Master Document List MR Contact appropriate parties that will be impacted by change

54 Management System Manual 12.0 Title: Document and Record Control 5 of Related Documents Master Document List Customer Drawing Folders CIF MSM Appendix A - Record Table 5.0 Revision History Revision Date Revision Details Initial release