DLC Machine, Inc. Quality Management System
QSM - 001 Rev 10
Page 1 of 32
DLC Machine, Inc.
Quality Management System
Manual
Revision History
Rev.Level / Section /
Revision
/ Date1 / All / Initial Release / 11/01/2007
2 / Appendix C / Revisions made to the following sections:
Appendix C was revised to include responsibilities of Office Manager and ISOmatrix / 1/28/08
3 / 5.6.2 / Documentation of preventative and corrective action / 12/22/08
3 / 7.5.1.2 / Incorporation of the President or designees designee / 12/22/08
3 / 7.1.4 / Control of work transferred on temp basis is incorporated / 12/22/08
4 / Logo change / 02/02/09
5 / 7.5.2 / Validation of Process is incorporated and no longer exempt / 12/15/09
6 / ALL / Conversion to AS9100-2009 Rev. C / 11/18/11
7 / ALL / Include Presidents Designee and New Org. Chart / 4/3/12
8 / 7.4.1.2 / Extended Approved Supplier List, from 2 Years to 3 years / 1/14/14
9 / 7.4.2 / Revised Document F_033 Note (j) has been added / 1/21/14
10 / 1.1,Appendix A, 1.2 / 1.1 Revised Scope Information, Appendix A. IOP was recreated to meet Dlc Machine’s Quality System Processes, 1.2. Section 7.5.1.4 was removed due to Dlc Machine providing post delivery support. Section 7.5 was removed due to Dlc Machine Servicing provisions / 5/20/14
Contents Page
Cover Page...... 1
Revision History...... 2
Contents Page...... 3
Company Background………………………………………………………………………..6
1.0Quality Policy Statement...... 7
1.1 Scope...... 8
1.2 Application...... 8
2.0References...... 9
3.0Terms and Definitions...... 9
4.0Quality Management System...... 10
4.1 General Requirements...... 10
4.2 Documentation Requirements...... 10
4.2.1General...... 10
4.2.2Quality Manual...... 11
4.2.3 Control of Documents...... 11
4.2.4 Control of Records ...... 11
5.0 Management Responsibility...... 12
5.1 Management Commitment...... 12
5.2 Customer Focus...... 12
5.3 Quality Policy...... 12
5.4 Planning...... 12
5.4.1Quality Objectives...... 12
5.4.2Quality Management System Planning...... 13
5.5 Responsibility, Authority and Communication...... 13
5.5.1Responsibility and Authority...... 13
5.5.2Management Representative...... 13
5.5.3Internal Communication...... 13
5.6 Management Review...... 13
5.6.1General...... 13
5.6.2Review Input...... 14
5.6.3Review Output...... 14
6.0Resource Management...... 15
6.1 Provision of Resources...... 15
6.2 Human Resources...... 15
6.2.1General...... 15
6.2.2Competence, Awareness and Training...... 15
6.3 Infrastructure...... 15
6.4 Work Environment...... 16
7.0Product Realization...... 16
Contents Page - continued
7.1 Planning of Product Realization...... 16
7.1.1 Project Management…………………………………………………………………..16
7.1.2 Risk Management……………………………………………………………………...16
7.1.3 Configuration Management……………………………………………………………17
7.1.4 Control of Work Transfers……………………………………………………………..17
7.2 Customer-Related Processes...... 17
7.2.1Determination of Requirements Related to the Product...... 17
7.2.2Review of Requirements Related to the Product...... 17
7.2.3Customer Communication...... 18
7.3 Design and Development...... 18
7.4 Purchasing...... 18
7.4.1Purchasing Process...... 18
7.4.2Purchasing Information...... 19
7.4.3Verification of Purchased Product...... 20
7.5 Production Provision...... 20
7.5.1Control of Production and ServiceProvision...... 20
7.5.1.1ProductionProcess Verification...... 21
7.5.1.2Control ofProduction Process Changes...... 21
7.5.1.3Control of Equipment, Tools and Software Programs...... 21
7.5.1.4Post Delivery Support...... 22
7.5.2Validation of Processes forProduction and Service Provision...... 22
7.5.3Identification and Traceability...... 22
7.5.4 Customer Property...... 22
7.5.5 Preservation of Product...... 23
7.6 Control of Monitoring and Measuring Devices...... 23
8.0Measurement, Analysis and Improvement...... 24
8.1 General...... 24
8.2Monitoring and Measurement...... 24
8.2.1Customer Satisfaction...... 24
8.2.2 Internal Audit...... 25
8.2.3Monitoring and Measurement of Processes...... 25
8.2.4Monitoring and Measurement of Product...... 25
8.3 Control of Nonconforming Product...... 26
8.4 Analysis of Data...... 27
8.5 Improvement...... 27
8.5.1 Continual Improvement...... 27
8.5.2 Corrective Action...... 27
8.5.3 Preventive Action...... 28
Contents Page - continued
Appendices
A. Interaction between the processes of The Quality Management System..29
B. Management Review Meeting Process...... 30
C. Organizational Chart, Responsibilities and Authority List...... 31
D.Quality Management System Relationship to AS9100 ...... 32
Company Background
DLC Machine, Inc. was founded in 1996. It has been providing the highest quality in precision machined products to the Aerospace, Military and Commercial Sectors for over 12 years. Combining equipment, personnel and over 25 years of preparation and experience, places DLC Machine, Inc. in a position to make a significant contribution to your machining projects. Our state-of-the-art facility enables us to supply our customers with the best quality, price and deliveryusing the latest in C.N.C.equipment. We have beensteadily growing over the past years and will continue to grow with our customers in a mutual partnership offering the best service along with their satisfaction.
We pride ourselves on our operations management system which is compliant with the AS9100 Aerospace Standard. Within its framework, the business, manufacturing, and quality processes, are designed to maximize production efficiency while maintaining the highest quality standards. We bring to you the most modern technology available today in our industry, and provide optimized and innovative manufacturing solutions to serve you faster and more cost effectively.
Quality Management Systems — Requirements
1.0 Quality Policy Statement
Quality Policy
We, at DLC Machine, Inc. accept the responsibility for the complete satisfaction of our customers. We exercise this responsibility through adequate training of our employees, adherence to proven procedures, total commitment to meeting and exceeding all requirements, and continually improving the effectiveness of the quality management system. We are committed to building quality partnerships with our customers by consistently providing quality products, optimized processing, and on-time delivery. To support this commitment, DLC Machine, Inc.has established a Quality Management System that will meet the AS9100 Standard.
DLC Machine, Inc.’s Quality Policy shall be understood, endorsed and implemented by all employees, at all levels throughout the organization.
DLC Machine, Inc.’s Quality Policy provides the framework for establishing quality objectives, and is reviewed periodically to ensure its continuing suitability and effectiveness.
Charlie Duong
President
DLC Machine, Inc.
1.1 Scope
The scope of the DLC Machine, Inc. Quality Management System is Applicable to: The Manufacture and assembly of fabricated metal parts utilizing precision CNC high-speed lathes and mills capable of machining all kinds of materials such as stainless steel, titanium, rubber, phenolics, inconel, plastics, aluminum, and other materials as per customer specifications for the aerospace industry
Type of products / processes:
●Precision CNC Machining / ●Deburring● Dimensional Inspection / ●Tumbling
Types of external support processes:
●Heat Treating / ●Plating●Deburring / ●NDT Inspection
Our customer base includes:
●Aerospace / ●Commercial●Military
1.2 Application
The DLC Machine, Inc. Quality Management System was established to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
The following AS9100,Rev. CAerospace Standard requirements have been excluded from the DLC Machine, Inc. Quality Management System, as they do not reflect the current business model or customer contractual requirements:
Section(s)
7.3 Design and Development
--Justification: Currently, all product designs are provided by customers, and therefore, no Design and Development activities are required or performed by DLC Machine, Inc.in the processing of its products.
2.0 References
The following references were used in construction of this Quality System Manual.
●AS9100,Rev. C Aerospace Standard, Quality Management Systems – Aerospace - Requirements
3.0 Terms and Definitions
The following terms and definitions are used with this manual:
●Organization = DLC Machine, Inc.
●Product = Intended deliverable for, or required deliverable by a customer. (Product can also mean Service)
●Supplier = A provider of materials, services, labor, or equipment. Also, referred to as Subcontractor.
●Customer = The external organization purchasing product / service from DLC Machine, Inc.
●Key Characteristics = The features of a material, process, or part whose variation has a significant influence on the product fit, performance, service life, or manufacturability.
●Contract = An accepted order from the customer.
●Controlled Document= Any document that is reviewed and approved before release for use or for reference.
●Multi-disciplinary Approach = Typically includes management, production, engineering, quality, and other appropriate personnel.
●Proposal = Offer made by an organization in response to an invitation to satisfy a contract award to provide product.
●Risk = An undesirable situation or circumstance that has both a likelihood of occurrence and a potentially negative consequence.
4 Quality Management System
4.1 General Requirements
DLC Machine, Inc. has established documented, implemented and maintains a Quality Management System and continually improves its effectiveness.The QMS will also address any customer and applicable statutory and regulatory requirement.
DLC Machine, Inc. has:
a) identified the processes needed for the quality management system and their application throughout the organization (see 1.2, Application),
b) determined the sequence and interaction of these processes (see Appendix – A),
c) determined the criteria and methods needed to ensure that both the operation and control of these processes are effective (see 7.5.1, Control of Production Provision).
d) ensured the availability of resources and information necessary to support the operation and monitoring of these processes,(see, 8.2.3, Monitoring and Measurement of Processes),
e) identified the methods to monitor, measure where applicable and analyze these processes(see 8.4, Analysis of Data), and
f) implemented actions necessary to achieve planned results and continually improvethese processes (see 5.6, Management Review.)
These above processes are managed by DLC Machine, Inc. in accordance with the requirements of this manual.
When, DLC Machine, Inc. chooses to outsource any process that affects product conformity with requirements, the organization ensures control over such processes. Control of such outsourced processes will be identified within the Quality Management System (see 7.4, Purchasing.)
Those processes needed for the Quality Management System referred to above will include processes for management activities, provision of resources, product realization and measurement(see Appendix – A.)
Evidence in complying with each of the above items is available within their references.
The DLC Machine, Inc.Quality Management System is reviewed in accordance withManagement Review Meetings (see 5.6, Management Review.)
4.2 Documentation Requirements
4.2.1 General
The DLC Machine, Inc.Quality Management System documentation (which can be made in any form or type of medium: hard copy or electronic) includes the following:
a) a documented Quality Policy and Quality Objectiveswill be referenced inAppendix-D, DLC Machine, Inc. QMS relationship to AS9100.(see 5.3, Quality Policy and 5.4.1, Quality Objectives.)
b) this manual,
c) documented procedures required specifically by the AS9100Standard, will be referenced inAppendix-D, DLC Machine, Inc. QMS relationship to AS9100.
d) documents needed by the organization ( such as procedures, instructions, forms, records, etc.) to ensure the effective planning, operation and control of its processes (see 4.2.3, Control of Documents),
DLC Machine, Inc. has ensured that personnel have access to the Quality Management System documentation and are aware of relevant procedures (see 4.2.3, Control of Documents.)
Customer and/or regulatory authorities’ representatives shall have access to quality management system documentation (see 4.2.3, Control of Documents.)
4.2.2 Quality Manual
DLC Machine, Inc.’sPresident or designee has established and maintains this manual for implementing the DLC Machine, Inc. Quality Management System which includes:
a) the scope of the Quality Management System, including details of and justification for any exclusions (see 1.2, Application),
b) those documented procedures establishing the Quality Management System and
c) a description of the interaction between the processes of the Quality Management System (see Appendix - A.)
4.2.3 Control of Documents
DLC Machine, Inc. has controlled all documents required by our Quality Management System.
Records are a special type of document and will be controlled in accordance with the requirements specified in section 4.2.4, of this manual (see 4.2.4, Control of Records.)
DLC Machine, Inc.has established a documented procedure that addresses the controls needed to:
a) approve documents for adequacy prior to issue;
b) review and update as necessary and re-approve documents;
c) ensure that changes and the current revision status of documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin determined necessary for the planning and operation of the QMS are identified and their distribution controlled;
g) prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose and
Refer toAppendix-D, DLC Machine, Inc. QMS relationship to AS9100.
4.2.4 Control of Records
DLC Machine, Inc. has established records and maintains these records to provide evidence of conformity to specified requirements and for the effective operation of our Quality Management System.
Records will remain legible, readily identifiable and retrievable.
DLC Machine, Inc. has established a documented procedure that addresses the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. This procedure also defines the method for controlling records that are created by and/or retained by suppliers.
Refer toAppendix-D, DLC Machine, Inc. QMS relationship to AS9100.
5.0 Management Responsibility
5.1 Management Commitment
DLC Machine, Inc.’s President or designee can provide evidence of its commitment to the development and implementation of the Quality Management System and continually improving its effectiveness by:
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements (see 8.2.2, Internal Audit),
b) establishing the Quality Policy (see 5.3, Quality Policy),
c) ensuring that quality objectives are established (see 5.4.1, Quality Objectives),
d) conducting management reviews(see 5.6 Management Review), and
e) ensuring the availability of resources (see 6.1, Provision of Resources.)
Evidence in complying with each of the above items is available within their references.
5.2 Customer Focus
DLC Machine, Inc.’s President or designee has ensured that customer requirements,such as on-time delivery and product conformity,are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1, Determination of Requirements Related to the Product, and 8.2.1, Customer Satisfaction.)
When applicable, Customer Focus will be addressed during our Management Review Meeting (see 5.6, Management Review.)
5.3 QualityPolicy
DLC Machine, Inc.’s President or designee has defined a Quality Policy and ensures that it
a) is appropriate to the purpose of the organization(see 5.6, Management Review),
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system (see 1.0,Quality Policy),
c) provides a framework for establishing and reviewing Quality Objectives (see 5.4.1, Quality Objectives)
d) is communicated and understood within the organization(see 8.2, Internal Audit), and
e) is reviewed for continuing suitability (see 5.6 Management Review.)
Evidence in complying with each of the above items is available within their references.
Refer toAppendix-D, DLC Machine, Inc. QMS relationship to AS9100.
5.4 Planning
5.4.1 Quality Objectives
DLC Machine, Inc.’s President or designee has ensured that Quality Objectives, including those needed to meet requirements for product (see 7.1, Planning of Product Realization), are established at relevant functions and levels within the organization.
The Quality Objectives are measurable and consistent with the Quality Policy.
Quality Objectives will be addressed during our Management Review Meeting (see 5.6, Management Review.)
Refer toAppendix-D, DLC Machine, Inc. QMS relationship to AS9100.
5.4.2 Quality Management System Planning
DLC Machine, Inc.’s President or designee has ensured that:
a) the planning (those exclusions identified within 1.2 Application) of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the Quality Objectives, and
b) the integrity of the Quality Management System is maintained when changes to the Quality Management System are planned and implemented.
When applicable, changes to the Quality Management System will be addressed during the Management Review Meeting (see 5.6, Management Review.)
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
DLC Machine, Inc.’s President or designee has ensured that responsibilities and authorities are defined and communicated within the organization.
This is accomplished by the implementation of the Organizational Chartand Responsibilities and Authority List. (see Organizational Chart and Responsibilities and Authority List, Appendix –C.)
When applicable, changes to Responsibility and Authority will be addressed during our Management Review Meeting (see 5.6, Management Review.)
5.5.2 Management Representative
DLC Machine, Inc.’s General Manageris the Management Representativeand irrespective of other responsibilities:
a) ensures that processes needed for the Quality Management System are established, implemented and maintained,
b) maintains the performance of the Quality Management System and any need for improvement (see 5.6, Management Review),
c) ensures the promotion of awareness of customer requirements throughout the organization, and
d)the organizational freedom and unrestricted access to top management to resolve matters pertaining to quality.
The Management Representative is responsible for addressing any issues or concerns during the Management Review Meeting (see 5.6,Management Review.)
5.5.3 Internal Communication
DLC Machine, Inc.’s President or designeehas ensured that appropriate communication processes such as: Posters, Employee Meetings, Bulletin Boards, etc. are implemented within the organization and that communication takes place regarding the effectiveness of the Quality Management System.
When applicable, internal communication will be addressed during the Management Review Meeting (see 5.6, Management Review.)
5.6 Management Review
5.6.1 General
DLC Machine, Inc.’s President or designeereviews the Quality Management System, at minimum of annual intervals, to ensure its continuing suitability, adequacy and effectiveness. (Management Review Meeting, Form F_002)
This review shall include assessing opportunities for improvement and the need for changes to the Quality Management System, including the Quality Policy and Quality Objectives (see 4.2 Quality Management System.)
The President or designee has identified the Management Review Meeting as the foundation for the success and health of the DLC Machine, Inc. Quality Management System (see The Management Review Meeting Process, Appendix –B.)
Records from Management Reviews shall be maintained (see 4.2.4 Control of Records).
5.6.2 Review Input
The input to Management Review includes information on:
a) results of audits such as: Internal Audits, Customer, Certification Bodies (Registrar), etc. (see 8.2.2, Internal Audits),
b) customer feedback, (see 7.2.3, Customer Communication and 8.2.1, Customer Satisfaction),
c) process performance and product conformity (see 8.2.3, Monitoring and Measurement of Processes and 8.2.4, Monitoring and Measurement of Product),