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AS 9100 Quality Systems Manual

CNC Dynamics, Inc.

1320 Distribution Way , Suite A

Vista , CA 92081

Phone: 760-598-0617

Fax: 760-598-9470

CNC Dynamics developed and implemented a Quality Management System in order to document the company’s best business practices, better satisfy the requirements and expectations of its customers and improve the overall management of the company.

The Quality Management System of CNC Dynamics meets the requirements of the international standard SAE AS 9100. This system addresses the design, development, production, installation, and servicing of the company’s products.

The manual is divided into eight sections that correlate to the Quality Management System sections of the ISO 9001:2000 format and AS 9100. Each section begins with a policy statement expressing CNC Dynamic’s obligation to implement the basic requirements of the referenced Quality Management System section. Each policy statement is followed by specific information pertaining to the procedures that describe the methods used to implement the necessary requirements.

This manual describes the Quality Management System, delineates authorities, inter relationships and responsibilities of the personnel responsible for performing within the system. The manual also provides procedures or references for all activities comprising the Quality Management System to ensure compliance to the necessary requirements of the standard.

This manual is used internally to guide the company’s employees through the various requirements of the AS 9100 standard that must be met and maintained in order to ensure customer satisfaction, continuous improvement and provide the necessary instructions that create an empowered work force.

This manual is used externally to introduce our Quality Management System to our customers and other external organizations or individuals. The manual is used to familiarize them with the controls that have been implemented and to assure them that the integrity of the Quality Management System is maintained and focused on customer satisfaction and continuous improvement.

A controlled copy of the Quality Management System distributed to the following individuals:

All QMS documentation including this manual, procedures, forms, attachments, and work instructions will be made available to Company personnel via the Company intranet. The address of the intranet site containing this QMS documentation is:

A Copy of the Quality manual will be made available to Customers, Vendors, and Regulatory Agencies via the Company internet Website address:

CNC Dynamics is a Manufacturing, Engineering, and Technical Services firm located in Vista California . The company specializes in the design, manufacturing, machining, fabrication, and assembly of commercial and aircraft components, products, and tooling.

Manufacturing provides machined, fabricated and assembled components and products.

Engineering services provide a complete array of engineering services. These services include Design, Drafting, Analysis and Finite Element Analysis (FEA), tool design, and project management.

Technical Services provide engineering product support and documentation such as: 2D/3D modeling detail drawings (CATIA, Soildworks, and PRO-E), Assembly & Installation drawings, System Documentation, Legacy drawing conversions, and Drawing updates & revisions.

The quality manual outlines the policies, procedures and requirements of the Quality Management System. The system is structured to comply with the conditions set forth in the International Standard SAE AS 9100.

CNC Dynamics has determined that no AS9100 exclusions are applicable to the operations of this company.

The following documents were used as reference during the preparation of the Quality Management System:

▪ Am eric an National Standard ANSI/AS 9001/ASQ Q9000-2000, Quality Management Systems - Vocabulary.

▪ Am eric an National Standard ANSI/AS 9001/ASQ Q9001-2000, Quality Management Systems – Requirements

▪ Am eric an National Standard ANSI/AS 9001/ASQ Q9004-2000, Quality Management Systems – Guidelines for performance Improvements

▪ Society of Automotive Engineers SAE AS 9100B - Quality Management Systems – Requirements

▪ Customer owned property - Any type of instrumentation, accessories, manuals, tooling or shipping containers that belong to a customer.

▪ Customer supplied product - Any type of service or material supplied to be utilized in the manufacture, modification or repair of customer-owned property.

▪ Product – The end item result of meeting all contract terms and conditions. (eg: manufactured goods, merchandise, services etc.)

▪ Quality Records – Documentation of those activities wherein records of said activities must be maintained will be specified in the procedure or work instruction level documents, as applicable

▪ Key Characteristics- The features of a material, process, or part whose variation has a significant influence on product fit, performance, service life, or manufacturability.

▪ Customer owned property - Any type of instrumentation, accessories, manuals, software, drawings, or documentation that belongs to a customer.

▪ Executive Management – Managing Directors of the Company who possess ownership interest in the Company.

▪ Production Illustration (PI) - A technical process developed for the creation of drawings used in the support of a production process and or work instruction. It is a comparison or an example needed for explanation, corroboration, or documentation within a process flow.

▪ Top Management – Departmental Managers from Operations, Engineering, Marketing, Manufacturing, Quality, and Administration.

CNC Dynamics has established, documented and implemented a Quality Management System (QMS) in accordance with the requirements of AS 9100. The system is maintained and continually improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action and management review.

▪ Identified the processes needed for the QMS and their application throughout the organization and documented them on the Process Flow Diagram at the end of this section of the Quality Manual

▪ Determined the sequence and interaction of these processes, and illustrated them on the Process Flow Diagram

▪ Determined criteria and methods needed to ensure that the operation and control of the processes are effective, and documented them in quality plans, work instructions and the Measuring, Monitoring and Analysis Table.

▪ Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes

▪ Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes

▪ Documents identified as needed for the effective planning, operation and control of our processes, and;

CNC Dynamics ensures that personnel have access to quality management system documentation and are aware of relevant procedures. We also provide customer or regulatory authorities access to quality management system documentation.

This Quality Manual has been prepared to describe the CNC Dynamics QMS. The scope and permissible exclusions of the QMS are described in section one of this manual. Each section of the manual references documented QMS procedures relating to the requirements outlined in that section. The Process Flow Diagram at the end of section 4 provides a description of the interaction between the processes of the QMS system. The relationship between the AS 9100 standard and documented procedure has been indicated by use of a numbering system that correlates to the AS 9100 standard.

All of the QMS documents are controlled according to the Document Control Procedure (AP-423). This procedure defines the process for:

▪ Ensuring that changes and current revision status of documents are identified

▪ Ensuring that relevant versions of applicable documents are available at points of use

▪ Ensuring that documents of external origin are identified and their distribution controlled

▪ Preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose and

▪ Obtaining customer / regulatory agency approvals when required by contract or regulatory requirements

▪ Coordinating document changes with customers or regulatory authorities in accordance with contract or regulatory requirements.

Quality records are maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. The records, including those created by or maintained by suppliers, are maintained according to the Control of Quality Records Procedure (AP-424). This procedure requires that quality records remain legible, readily identifiable and retrievable. Records are available for review by customers and regulatory authorities in accordance with contract or regulatory requirements. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of quality records. Records are made available to customers / regulatory agencies when required by contract or regulatory requirements.

The organization has established, documented and maintains a configuration management process that is appropriate to the product.

Top Management has been actively involved in implementing the quality management system (QMS). It has provided the vision and strategic direction for the growth of the QMS, and established quality objectives and the quality policy.

To continue to provide leadership and show commitment to the improvement of the QMS, management will do the following.

▪ Communicate the importance of meeting customer, statutory, and regulatory requirements.

CNC Dynamics strives to identify current and future customer needs, to meet customer requirements and exceed customer expectations.

Top Management ensures that customer requirements are understood and met, by requiring compliance with documented customer communication procedures. Customer requirements are determined, converted into internal requirements, and communicated to the appropriate people in our organization (SP-720).

“CNC Dynamics inc. is committed to deliver high-quality products that meet the needs and expectations of our customers. we will actively pursue ever improving quality through programs that enable each employee to do their job right the first time and every time.”

Top Management ensures that the quality policy is communicated to all employees. It is included in new employee training and training on the QMS, and is posted in prominent places throughout the facility to maintain high standards within our organization.

Management reviews the quality policy at each management review meeting to determine the policy’s continuing suitability for our organization. The Quality Policy is documented on AP-501.

Quality objectives are established to support our organization’s efforts in achieving our quality policy and reviewed annually for suitability. Quality objectives are determined at Company, departmental, and functional levels; are measurable; and are reviewed against performance goals throughout the year. Quality objectives are measurable, and reviewed against performance goals at each management review meeting.

The quality system has been planned and implemented to meet our quality objectives and the requirements of 4.1 of the AS 9100 standard. Quality planning takes place as changes that affect the quality system are planned and implemented.

An organizational chart has been established to show the interrelation of personnel in the organization. Job descriptions define the responsibilities and authorities of each of the positions on the organizational chart. Job descriptions and the organizational chart are reviewed and approved by top management for adequacy. These documents are available throughout the organization to help employees understand responsibilities and authorities. An organizational chart is located on page 5 of this manual.

The Quality Manager has been appointed by Top Management as the management representative. As management representative, they have the following responsibility and authority:

▪ Ensure that processes needed for the quality management system are established and implemented.

▪ Report to top management on the performance of the quality management system, and note needed improvements.

▪ Act as a liaison with external parties such as customers or auditors on matters relating to the QMS and

Processes are established for communication within the organization. Methods of communicating the effectiveness of the QMS include department and management meetings, management review, circulation of minutes of management review meetings, Internal Audit Closing meetings, and other routine business communication.

Executive and Top Management review the QMS at management review meetings. This review assesses the continuing QMS suitability, adequacy and effectiveness, identifying opportunities for improvement and needed changes. Records are maintained for each management review meeting.

Assessment of the QMS is based on a review of information inputs to management review. These inputs include the following:

During these review meetings, management will identify appropriate actions to be taken regarding the following issues:

§ Improvement of the effectiveness of the quality management system and its processes

Responsibility for required actions is assigned to members of the management review team. Any decisions made during the meeting, assigned actions, and their due dates are recorded in the minutes of management review.

CNC Dynamics has implemented a Quality Management System that complies with the AS 9100 standard. This implementation was achieved with management commitment and with sufficient resources for the implementation. To effectively maintain and continually improve the system, management determines and provides necessary resources.

To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications required for each position that affects product quality. Qualifications include requirements for education, skills and experience. Appropriate qualifications, along with required training, provide the competence required for each position.

Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position change. Human resources maintain records of employee qualifications. If any differences between the employee’s qualifications and the requirements for the job are found, training or other action is taken to provide the employee with the necessary competence for the job. The results are then evaluated to determine if they were effective. Training and evaluation are conducted according to the Training procedure. (AP-622)

All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.

A work environment suitable for achieving product conformance is maintained. Requirements are determined during quality planning and documented in the quality plan. The work environment is managed for continuing suitability. Data from the quality system is evaluated to determine if the work environment is sufficient for achieving product conformance, or if preventive or corrective action related to the work environment is required.

Quality planning is required before new products or processes are implemented. The quality planning may take place as a design project, or according to the Planning of Product Realization procedure (MP-710). During this planning, management or assigned personnel identify:

The output of quality planning includes documented quality plans, processes, procedures and design outputs.

CNC Dynamics determines customer requirements before acceptance of an order. Customer requirements include those:

▪ Not stated by the customer but necessary for specified use or known and intended use

Customer requirements are determined according to the Customer Related Processes Procedure. (SP-720)

CNC Dynamics has a process in place for the review of requirements related to the product (SP-720). The review is conducted before the order is accepted. The process ensures that:

▪ Contract or order requirements differing from those previously expressed are resolved

▪ Records are maintained showing the results of the review and any actions arising from the review

▪ Where a customer does not provide a documented statement of requirement, the customer requirements are confirmed before acceptance

▪ When product requirements are changed, CNC Dynamics communicates changes to relevant personnel and amends relevant documents

▪ Risks (e.g., new technology, short delivery time scale) have been evaluated.

CNC Dynamics has implemented an effective procedure (SP-720) for communicating with customers in relation to:

The design and development procedure (EP-730) outlines the process for controlling the design and development process. The Engineering Department plans design and development according to this procedure. The design plan includes:

▪ Design and development stages including organization, task sequence, mandatory steps, significant stages and method of configuration control,

▪ Required design reviews, verification and validation appropriate to each design stage

▪ Where appropriate, due to complexity, the organization gives consideration to the following activities:

Ø For each element, analyzing the tasks and the necessary resources for its design and development. This analysis considers an identified responsible person, design content, input data, planning constraints, and performance conditions. The input data specific to each element is reviewed to ensure consistency with requirements.

▪ Verification and validation methods appropriate to each design and development stage

▪ The different design and development tasks to be carried out, defined according to specified safety or functional objectives of the product in accordance with customer or regulatory authority requirements.

Inputs relating to product requirements are determined and documented according to the Design and Development procedure (EP-730). All inputs are reviewed for adequacy and completeness, and to resolve any ambiguous inputs. Inputs include:

Outputs of design and development are documented according to the Design and Development Procedure (EP-730). They are documented in a format that enables verification against the inputs, and are approved prior to release. Outputs:

▪ Provide appropriate information for purchasing, production and for service provision

▪ Specify the characteristics of the product that are essential for its safe and proper use.

▪ Identify key characteristics in accordance with design or contract requirements (EP-731)

All pertinent data required to allow the product to be identified, manufactured, inspected, used and maintained is defined by the organization according to the Design and Development Procedure (EP-730)

The design plan specifies suitable stages of the project to conduct design and development review. Reviews take place according to the design and development procedure; results of design review are recorded in minutes of the design review meetings which are maintained as a quality record. Design reviews:

▪ Evaluate the results of design and development activities and determine if they fulfill requirements

▪ Include representatives of functions concerned with the design and development stage being reviewed to authorize progression to the next stage.

Design verification is planned and performed to ensure that the design and development outputs have satisfied the design and development input requirements. Records of the results of the verification and any necessary actions are maintained according to the Design and Development procedure (EP-730).

Design and development validation is performed according to the design plan to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application. Validation is completed prior to delivery whenever practicable. Records of the validation activities are maintained according to the design and development procedure.

At the completion of design and/or development, the organization ensures that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions.

Where tests are necessary for verification and validation, these tests are planned, controlled, reviewed, and documented to ensure and prove the following:

▪ Test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded, and relevant acceptance criteria

▪ Test procedures describe the method of operation, the performance of the test, and the recording of the results

The design and development procedure defines a process for identifying, recording, verifying, validating and approving design changes. The review of design and development changes includes an evaluation of the effect of the changes on constituent parts and delivered product. Records are maintained to show the results of the review and any necessary actions identified during the review. This procedure provides for customer or regulatory authority approval of changes, when required by contract or regulatory requirement.

A documented procedure (AP-740) is followed to ensure that purchased product conforms to the specified purchase requirements. The procedure outlines the extent of control required for suppliers. Suppliers are evaluated and selected based on their ability to supply product in accordance with requirements as outlined in the procedure. Criteria for selection, evaluation and re-evaluation are documented in the procedure. Records of the evaluation and any necessary actions are maintained as quality records. The organization is responsible for the quality of all products purchased from suppliers, including customer-designated sources.

Purchasing information describes the product to be purchased, including where appropriate:

▪ Quality management system requirements outlined in the Purchasing Procedure (AP-740)

The purchasing documents are reviewed to ensure the adequacy of requirements before orders are placed with the supplier.

The Purchasing procedure (AP-740) describes the process used to verify that purchased product meets specified purchase requirements. Purchased product is not used or processed until it has been verified as conforming to specified requirements unless it is released under positive recall procedure. If test reports are used to verify purchased product, the data must meet applicable specifications. Test reports for raw material are periodically validated.

When verification activities are delegated to the supplier the requirements are defined, and a register of delegations is maintained.

If CNC Dynamics or the customer will perform verification at the supplier’s premises, the verification arrangements and method of product release are documented in the purchasing information. Where specified in the contract, the customer or the customer’s representative is given the right to verify at the suppliers premises and organization’s premises that product conforms to specified requirements

CNC Dynamics plans and carries out production and service provision under controlled conditions according to documented procedure (MP-750). Planning considers, as applicable:

▪ The establishment of process controls and development of control plans where key characteristics have been identified,

▪ The identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of realization,

▪ The design, manufacture, and use of tooling so that variable measurements can be taken, particularly for key characteristics, and

▪ The availability of information that describes the characteristics of the product

▪ accountability for all product during manufacture (e.g., parts quantities, split orders, nonconforming product), part accountability to ensure bad parts have been destroyed

▪ evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized,

1.1 General

1.2 Application

2.0 Quality Management System References

3.0 Quality Management System Definitions

4.1 General requirements

4.2 Documentation Requirements

Related Procedures

5.2 Customer focus

5.3 Quality policy

“CNC Dynamics inc. is committed to deliver high-quality products that meet the needs and expectations of our customers. we will actively pursue ever improving quality through programs that enable each employee to do their job right the first time and every time.”

5.4 Planning

5.5 Responsibility, authority and communication

5.6 Management review

Related Procedures:

6.1 Provision of resources

6.2 Human resources

6.3 Infrastructure

6.4 Work Environment

Related Documents

7.1 Planning of product realization

7.2 Customer-related processes

7.3 Design and Development

7.4 Purchasing

7.5 Production and Service Provision