QUALITY MANUAL W.R. Larson Rd. P. O. Box San Antonio, Texas San Antonio, Texas (830) (210) FAX

Transcription

1 Company Location: Postal Address: 2420 W.R. Larson Rd. P. O. Box San Antonio, Texas San Antonio, Texas (830) (210) FAX David Martinez, Vice President Bradley Buchanan, QA Manager

2 INTRODUCTION D & D Machinery & Sales, Inc. was established in 1983 as a distributor and exporter of replacement parts for construction, industrial, and hydraulic equipment. After incorporating in 1984, D & D (named after owners, David and Dolores Martinez) began to manufacture its own parts and soon specialized in precision manufacturing and fabrication. Three years later, D & D began to manufacture ground support and aircraft maintenance equipment, vehicular accessories, system components, and other miscellaneous equipment for the USAF and commercial airline customers as an 8A (small/disadvantaged business) contractor. In 1997, D & D moved from 8A to become a Blue Ribbon Contractor (AF Logistics Command) by successfully completing an order for TTF90 (C-17) Engine Transport Trailers which included reverse engineering due to data deficiencies.. D & D Machinery & Sales, Inc. has also joined the Boeing family of Preferred Suppliers as a direct supplier to the C- 17 Production Program at Long Beach, California. D & D is classified by the Small Business Administration (SBA) as a small, woman-owned business. D & D actively supports the efforts of the SBA by serving on the Region IV Board and in an advisory capacity to the National Ombudsman. Our facilities and shops consist of the latest in CNC machinery and welding capabilities and cover 105,000 square feet on six acres. There is an additional 40 acres available for expansion, all of which is within 15 miles of the San Antonio airport. Our Quality Management System (QMS) is designed to meet the requirements of International Aerospace Standard SAE AS9100 Revision C, Quality Management System Requirements for Aviation, Space and Defense Organizations and D Revision F, 2011, Boeing Quality Management System Requirements for Suppliers. D & D remains a family owned and operated business committed to high quality standards, lean manufacturing techniques, on time delivery, and the complete satisfaction of our customers. My original signature below attests to my commitment to you David Martinez, Vice-President and Chief Operating Officer TABLE OF CONTENTS Page 2 of 15

3 Cover Page 1 Introduction 2 Table of Contents 3 Revision Summary 3 Scope/Exclusions 4 SECTION 4 - QUALITY MANAGEMENT SYSTEM 5 SECTION 5 - MANAGEMENT RESPONSIBILITY 7 SECTION 6 RESOURCE MANAGEMENT 10 SECTION 7 PRODUCT REALIZATION 11 SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 14 REVISION SUMMARY Revision Revision Date Revision Description A 8/28/07 Initial Release B 10/24/07 Typographical errors and clarification of some narratives C 3/25/08 Revised following AS9100B Audit D 3/28/08 Cross Reference, 1.2, added E 2/02/12 Revised to meet AS9100C F 6/27/12 Change in Company Objectives, exclusions, process map and overall format G 8/8/12 Updated QMS Process Map H Expounded para 5.6; added Approved Supplier Guidance to para 7.4; para approval media managed by the Quality Manager; removed last sentence in para 8.1; added Work Order and QMS Form narrative to para I Added Index of Operational Procedures to para as reference to the procedures used in the QMS. J Revised figure Process Map K Included new company logo, revised fig 4.1.1, revised exclusion to match OASIS Database. Note: This is a Controlled Document. The current version is maintained on the Company server and is document protected. Copies of this document are uncontrolled. Page 3 of 15

4 Scope D & D Machinery and Sales, Inc. manufacture and assemble customer designed ground support equipment for the support of The Boeing Company C-17 Project. The key processes are identified in Figure The various process functions are detailed in Company QMS documents that support AS9100C clauses. The QMS has been developed to provide the Company a means to deliver quality products that meet customer and applicable regulatory and statutory requirements. It is structured to address customer satisfaction by meeting or exceeding customer expectations through the effective application of defined processes, including continuous process improvement and the systematic prevention of parts nonconformity. Exclusions: Design and Development is excluded as D&D manufactures and assembles to customer supplied designs and drawings (ref: Clause 7.3). Page 4 of 15

5 4. Quality Management System 4.1 General Requirements: The QMS is designed as a system of interrelated processes. The Company has identified three major areas: Management Processes: These support the overall business plan, guidance and policies that give direction to the organization Support Processes: These support the Customer Oriented Product Realization Processes both directly and indirectly and include such areas as facilities, training, admin, supplies, tools, equipment, etc. Customer Product Realization Processes: These are the processes that manufacture/fabricate product. These are the most important in satisfying customer requirements and identify how we do business as a company The interrelationship between the various processes is illustrated in the QMS Process Map diagram below. Figure Page 5 of 15

6 4.1.2 QMS documents and records provide the guidance and evidence to ensure that the QMS processes are effective. The company has determined: a. The processes needed for the QMS and how they apply throughout the organization. These are explained in this manual and in the associated D&D Procedures. b. The sequence of the processes and how they interact throughout product realization. c. The criteria and methods needed to ensure both the operation and the control of these processes are effective. d. That appropriate resources are in place and information available to ensure proper operation and monitoring of these processes. e. That applicable processes are monitored and measured for success. f. The necessary actions to ensure planned results are achieved This Company does utilize outside sources. See paragraph for details. 4.2 Documentation Requirements: General: The Company has developed documentation to ensure that quality; consistency and reliability are part of all production jobs. QMS documentation consists of Company quality policy, objectives, Quality Manual and procedures that conform to the applicable clauses of AS9100 and provides evidence of conformity Quality Manual: Although AS9100C does not require a clear relationship between the Standard and QMS documentation, the Quality Manual was developed logically following the clauses of AS9100. This manual includes: The scope of the QMS and exclusions, Reference to our documented procedures are identified on QMS Form 4230, Index of Operational Procedures Described interaction of the processes identified within the QMS Control of Documents: Documents required by the Standard are controlled and protected on the Company server. The Company has developed a documented procedure that defines how documents are controlled within the company Control of Records: The Company has developed a documented procedure to control records that provide evidence of conformity. It defines what is required for record identification, storage, protection, retrieval, retention time and disposition. These records are maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. The records are electronically maintained to provide legibility and are readily identifiable and retrievable. Page 6 of 15

7 5. Management Responsibility 5.1 Management Commitment: The Company is committed to operating a QMS that meets and/or exceeds the requirements of AS9100 and continually improving its effectiveness through the following: a. Communicate to the organization the importance of meeting customer requirements as well as all statutory and regulatory requirements. That information is communicated through briefings, meetings, s and through the Company QMS. b. The company quality policy has been established and made available to view by all personnel. The policy is posted in several locations around the facility and is presented in our new employee orientation briefing. c. Established quality objectives that are reviewed routinely for success and revision as needed. d. Management reviews which are held at least once a year and routinely scheduled staff meetings provide status on the health of the Company. e. Resources determined and reviewed in Management Reviews, Staff Meetings as needed to meet customer requirements and ensure company success. 5.2 Customer Focus: Top Management ensures that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not met, or will not be achieved. Top Management is responsible for implementing this commitment by promoting awareness of customer requirements throughout the company with the aim of enhancing customer satisfaction. 5.3 Quality Policy: Top management ensures that the quality policy: a. Is appropriate for the organization and provides guidance to the lowest level within the organization. b. The policy further includes our commitment to comply with the requirements of AS9100 and make every effort to improve the effectiveness of the QMS. c. The policy provides a framework for ensuring Company objectives meet or exceed customer satisfaction and if not, provides an avenue for review and change if needed for continuing suitability. d. Is communicated to all levels of the company through posted notifications, periodic publications, meetings and other means deemed appropriate by management. e. The policy is reviewed at least annually through management reviews for continuing suitability. Page 7 of 15

8 D&D Quality Policy At D & D, our customers are our sole reason for being in business. They will be treated as friends and partners and their expectations met without exception. Superior workmanship, sound business practices and the continued process of quality improvement has earned us an exceptional reputation. Our reputation depends on never forgetting the needs and the importance of our friends. The Quality Policy is posted in several locations within the Company and discussed during orientation training. 5.4 Planning: Quality objectives: Top management ensures that quality objectives are established at relevant levels and functions and levels within the organization. These are measurable and consistent with the quality policy. Top Management will revise the objectives as needed. There are three objectives based on the April 2012 Management Review: 1. Meet or exceed a 99.5% customer acceptance rating based on part count acceptance/rejection. 2. Meet or exceed a 97% customer on time delivery rating. 3. Maintain a customer satisfaction rating of 3.0 out of a possible rating of 4.0 based on our D&D Customer Surveys sent to our customer QMS planning: Top management ensures both the quality policy and objectives of the QMS are applied to measure success and organizational performance and to document the expectations and needs of the customer. a. The QMS is planned and carried out to meet the requirements outlined in section 4.1 of the Standard. Management is ultimately responsible for establishing, maintaining, and improving the QMS through Company operational procedures, establishing the quality policy and quality objectives, conducting Management Reviews, Internal Audits, and ensuring the availability of adequate resources. b. All planning is evaluated by Top Management at regular intervals and changes to the QMS are adjusted according to changes in Company conditions, strategy, customer requirements, technological advances, market pressure or other circumstances. Page 8 of 15

9 5.5 Responsibility, authority and communication: Responsibility and authority: The Company Organizational Chart is retained on the Company Server and depicts the lines of responsibility and departmental functions Management Representative: By the authority of this document, the Vice President has appointed the Quality Manager as the Management Representative. The Management Representative has the responsibility and authority to: a. ensure that processes needed for the QMS are established, implemented and maintained in accordance with AS9100. b. report to top management on the QMS and any need for improvement. c. ensuring the promotion of awareness of customer requirements throughout the Company and, d. have the organizational freedom and unrestricted access to top management to resolve matters of quality within the company Internal communication: Top management ensures that appropriate communications processes are in place within the Company and that communication reaches the lowest level regarding the effectiveness of the QMS. Such communications are provided via internal audits, postings, bulletin boards, internal memos, s and during company meetings, etc. 5.6 Management Review: General: Top Management reviews the QMS at planned intervals to ensure continuing suitability, adequacy and effectiveness. Data indicating the suitability and effectiveness of the QMS is compiled and presented to top management. The review includes any opportunities for improvement and the need for changes to the QMS, including quality policy and objectives. The records for management reviews and any supplementary meetings are maintained on the Company Server in accordance with clause Management Review looks at a number of inputs such as audits, customer feedback, conformity of product, business changes as well as management recommendations for change The output of the Management Review will be the decisions made by Management that affects the quality system as well as identifying resource needs and anything else needed to meet continued customer requirements. Page 9 of 15

10 6. Resource Management 6.1 Provision of resources: Top Management ensures that adequate resources are available to implement and maintain the QMS and continually improve its effectiveness and enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources: General: Those personnel who perform work affecting conformity of product shall be competent based on appropriate education, training, skills and experience. The immediate supervisor identifies employee training needs, assists with training, and evaluates the effectiveness of the training provided Competence, Training and Awareness: Company training procedures such as on the job training and recurring training are used. a. The supervisor determines the competence level necessary to ensure employees are performing work that successfully supports product quality. b. The Company provides training of various kinds to ensure employee competence to satisfy production quality. c. The supervisor performs individual assessment of employee performance at regular intervals to ensure training has been effective. d. The Company manages required employee certifications. Employees are made aware of the relevance of their activities and how they contribute to the achievement of quality objectives. Records of personnel qualifications, certifications and training are maintained. e. All employee records are maintained in accordance with section of this manual. Training records are maintained by QA. 6.3 Infrastructure: Company resources are applied to provide and maintain the infrastructure needed to achieve conformity to product requirements. These resources include: a. buildings, workspace and associated utilities, b. supplies, process equipment (both hardware and software) and, c. any supporting services as necessary. 6.4 Work environment: The Company strives to provide a favorable work environment for its employees to achieve conformity for product. Page 10 of 15

11 7. Product Realization All processes for the manufacture of product to satisfy customer requirements are encompassed in clause 7 of the Standard. The flow chart below depicts the processes and flow beginning with a customer purchase order and finalized in delivery and post-delivery support. Page 11 of 15

12 7.1 Planning of product realization: The Company plans and develops the processes needed to ensure effective product realization. These processes are consistent with the requirements of the other processes included in the QMS. The output of this planning is our D&D Job Traveler which defines all operations of product realization Project Management: As a small company we have limited the scope of project management while still maintaining a structured and controlled system to meet requirements at acceptable risk, within resources and schedule constraints. The Company places increased focus on planning to ensure that product realization is realistic and obtainable given the resources and time allowed Risk Management: The Company has established a process for evaluating risk that is appropriate to the requirements and product developed. Company procedures involving planning and customer related processes further define the risk process. It defines responsibilities, risk criteria, management throughout product realization, and mitigation of risk and acceptance of risk following mitigation Configuration Management: The Company has established a configuration Management (CM) process that is in line with customer life cycle management and provides integrity of product throughout our manufacturing processes. CM includes product: Planning Identification Change control Configuration status accounting Configuration verification and audit Control of Work Transfers: The Company has established, implemented and maintained a process to control work transferred, on a temporary basis, outside Company facilities to approved suppliers. This process is managed by Planning and Purchasing. The control to suppliers is defined in our purchase process, company generated purchase orders and this manual. The transfer of work does not absolve the Company from its liability or responsibility of conformity to the customer, statutory or regulatory requirements. 7.2 Customer-related processes: The Company determines and defines requirements related to the product in support of customer requirements. Established and defined Company processes outline how the company determines customer requirements Customer communication: The Company continually communicates and interfaces with the customers for the collection, analysis, and distribution of customer information which are necessary to understand customer requirements and are indispensible for quoting, contract review and planning. 7.3 Design and development (Excluded) 7.4 Purchasing: Purchasing of product begins with ensuring that purchased product conforms to our specified purchase requirements. Only approved suppliers are utilized in providing materials and products for use in product realization. The QA department is responsible for evaluating and approving potential suppliers, allowing the Company to purchase only from those suppliers that Page 12 of 15

13 measure up to defined quality requirements. The extent of control over suppliers is based on the purchased product and its affect or impact on subsequent product realization and/or final product. The Company provides an Approved Supplier Guidance procedure to all approved suppliers. This procedure defines company requirements such as purchase order flow-down, quality expected, nonconforming product and general guidance for the purchasing process, purchasing information and verification of purchased product. 7.5 Production and service provision Control of production and service provision: Product realization is planned and carried out under controlled conditions. Company procedure provides guidance for control of production and service provision through process verification, process change and control of production equipment, tools and software. Finally, Company procedure details post-delivery support Validation of processes for production and service provision: Production processes are normally validated by applicable methods, such as measurements of product and equipment qualification. However, special processes are those processes that are validated through other means where resulting output cannot be verified by subsequent monitoring or measurement. Company procedure is provided for the guidance to validate special processes and to demonstrate the ability of these processes to achieve planned results Identification and traceability: Throughout product realization, the product must be suitably identified. Company procedure includes assignment of part numbers and job numbers to control the identification of the product. The identification of the configuration of the product is strictly controlled throughout realization to ensure any differences are identified between the actual configurations and agree configuration. Product status is continually monitored through company software and measurements of product are stipulated through In-process inspections in the job traveler. Acceptance authority media (Company Inspection Stamps) is controlled by the Quality Manager Customer Property: Customer property may be required to assist in the product realization process. Customer property may include intellectual materials, customer furnished data used for design, production and/or inspection. This property, no matter what media, will be provided the protection and care needed to prevent damage, loss or compromise of proprietary information. Records will be maintained under the guidance of section 4.2 of this manual and company procedures for record documentation Preservation of Product: The Company preserves the conformity of all products during the entire product realization process. Company procedure identifies steps to be taken that include proper identification, handling, packaging, storage and protection. Preservation of product will include where applicable by purchase order, product specifications, applicable statutory and regulatory requirements, and provisions for: cleaning, prevention, detection and removal of foreign objects, special handling for sensitive products, marking and labeling including safety warnings, shelf life control and stock rotation and special handling for hazardous materials. 7.6 Control of Monitoring and Measuring Equipment: Company Management maintains a quality measurement capability through its Quality Assurance (QA) Department. Company procedure determines the monitoring and measurement to be undertaken and the equipment needed to provide evidence of conformity of product. Page 13 of 15

14 8. Measurement, Analysis and Improvement 8.1 General: Company Management, plans and implements monitoring, measurement and improvement processes needed to demonstrate conformity to product requirements, ensure conformity to the QMS and continually improve the effectiveness of the QMS. 8.2 Monitoring and Measurement Customer Satisfaction: Customer satisfaction is the principal measurement of the effectiveness of the QMS. Customer satisfaction is also the highest management goal of the Company (See Section 5.2, Customer Focus). At a minimum customer satisfaction is measured by assessing product conformity, on-time delivery performance, customer complaints and corrective action requests (CARs) and customer returns Internal Audit: Company departments and activities related to QMS operations are internally audited at least once a year. Company procedure provides guidance to perform the Internal Audit to determine whether the QMS conforms to planned arrangements and has been effectively implemented and maintained Monitoring and Measuring of Processes: QMS processes are monitored by a variety of techniques as appropriate for a particular process and its importance. These methods demonstrate the ability of the processes to achieve planned results. The Company has developed Company Department Processes (CDP) which provide detailed information on how each process is accomplished and how each processes interacts with others which makes up our business model for the QMS. See figure in this manual. The CDPs provide a basis for understanding how we do business and are used as part of Company Internal Audits Monitoring and Measurement of Product: Production management monitors and measures the characteristics of the product to verify that product requirements have been met. The inspection and testing approach for product is defined in various types of documents, such as product drawings and specifications. The Company Work Order and QMS Inspection Forms provide the means to monitor and measure product. 8.3 Control of Nonconforming Product: Implementation of the QMS ensures that nonconforming product (NCP) is identified, documented, evaluated, and prevented from being used or delivered. Company procedure has been established to define the controls and related responsibilities for dealing with nonconforming product. 8.4 Analysis of Data: The Company collects and analyzes information to determine the effectiveness of the QMS. The information includes data generated as a result of monitoring and measurement of product and services from Company departments, customers, and relevant to continuous process improvement. QA is reports the information to management who responsible for effectiveness of the QMS. Information collect are customer satisfaction; conformity to product and customer requirements; characteristics and trends of processes and products including opportunities for preventive action and suppliers/subcontractors performance. Page 14 of 15

15 8.5 Improvement Continual improvement: The Company continually improves the effectiveness of the QMS through the use and analysis of our quality policy, objectives, and audits, analysis of customer data, product conformity, corrective/preventive action and management review of these factors Corrective Action: The need for corrective action is determined on the basis of identified nonconformities or when there are trends that indicate decreasing quality capability or decreasing effectiveness of the QMS. Corrective actions shall be appropriate to the effects of the nonconformities encountered. Company procedure is in place that addresses: a. Reviewing nonconformities (including customer complaints) b. Determining the causes of nonconformities. c. Evaluating the need for action to ensure that nonconformities do not recur. d. Determining and implementing action needed. e. Records of the results of action taken. f. Reviewing the effectiveness of the corrective action taken. g. Flowing down of the corrective action requirements to a supplier, when it is determined that the supplier is responsible for the nonconformity h. Specific actions where timely and/or effective corrective actions are not achieved. i. Determining if additional NCP exists based on the causes of the nonconformities and taking further action when required Preventive Action: Preventive actions are implemented to eliminate the causes of potential nonconformities in order to prevent their occurrence. The Company must look for all opportunities to identify preventive action. Such opportunities are risk management, error proofing our processes, looking at particular failures in product and information gained from external sources. Company procedure defines: a. Determining potential nonconformities and their causes. b. Evaluating the need for action to prevent occurrence of nonconformities. c. Determining and implementing action needed. d. Records of results of action taken. e. Reviewing the effectiveness preventive action taken. Page 15 of 15