AS 9100 Quality Systems Manual

CNC Dynamics, Inc.
939 Poinsettia Ave, Suite 302
Vista, CA 92081
Phone: 760-598-0617
Fax: 760-598-9470


CNC Dynamics developed and implemented an AS 9100 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 AS 9100 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 AS 9100 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 AS 9100 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 AS 9100 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 AS 9100 Quality Management System is maintained and focused on customer satisfaction and continuous improvement.

AS 9100 Quality Systems Manual Distribution

The AS 9100 Quality Systems Manual shall be electronically distributed to the following:
Management Representative, 
Production Personnel,
Shipping and Receiving, 
Contracts and Customer Service, 
Human Resources,
A controlled paper copy of the AS 9100 Quality Management System will be distributed to the following individuals:
Marketing Manager, 
Production Manager
Engineering Manager,
Quality Manager,
Administrative Manager,
All AS 9100 QMS documentation including this manual, procedures, forms, attachments, and work instructions are available to Company personnel via the Company Local Area Network: D:/CNC DYNAMICS DOCUMENTS/AS9100

A Copy of the AS 9100 Quality Systems Manual is available to Customers, Vendors, and Regulatory Agencies via the Company internet Website address:

Section 1: Scope

1.1 General

CNC Dynamics is a aerospace and commercial products manufacturing, engineering, and technical services firm, located at 939 Poinsettia Ave, Ste. 302, Vista, California, 92081. CNC Dynamics specializes in machining, fabrication and assembly of aircraft and commercial products and tooling.

Manufacturing provides machined, fabricated and assembled aircraft and commercial products and tooling.

Engineering provides design, drafting, tool design, manufacturing planning, and project management, and analysis and finite element analysis (FEA). 

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

1.2 Application
CNC Dynamics has determined that no AS9100 exclusions are applicable.

Section 2: Normative Reference

2.0 AS 9100 Quality Management System References

The following documents were used as reference during the preparation of the AS 9100 Quality Management

▪        American National Standard ANSI/AS 9001/ASQ Q9000-2000, Quality Management Systems - Vocabulary.
▪        American National Standard ANSI/AS 9001/ASQ Q9001-2000, Quality Management Systems - Requirements
▪        American 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

Section 3: Definitions

3.0 Quality Management System Definitions

This section is for definitions unique to CNC Dynamics.

▪        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.

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

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

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

▪        Product - The end item result of meeting all contract terms and conditions (e.g.: manufactured goods, drawings, data, services etc.)

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

▪        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.

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

Section 4: General Requirements

4.1 Quality Management System General Requirements
CNC Dynamics has established, documented, and implemented an AS 9100 Quality Management System (QMS) in accordance with the requirements of SAE 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.

To design and implement the AS 9100 QMS CNC Dynamics has:

▪        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 AS 9100 Quality Systems 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 systems to monitor, measure and analyze these processes, and;

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

Documentation Requirements

4.2.1 General

The AS 9100 QMS documentation includes:

▪        A documented Quality Policy
▪        This AS 9100 Quality Systems Manual
▪        Documented Procedures
▪        Work Instructions
▪        Documents identified as needed for the effective planning, operation and control of our processes, and;
▪        Quality Records
▪        Records required by regulatory authorities.

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.

4.2.2 AS 9100 Quality Systems Manual

This AS 9100 Quality Systems 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.

4.2.3 Control of documents

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

▪        Approving documents for adequacy prior to issue
▪        Reviewing and updating as necessary and re-approving documents
▪        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 remain legible and readily identifiable
▪        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.

4.2.4 Control of quality records

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.

4.3 Configuration Management:

The organization has established, documented and maintains a configuration management process that is appropriate to the product. The configuration management process is covered by engineering procedure EP-430-001.

Related Procedures

Document Control                AP-423
Control of Quality Records        AP-424
Configuration Management    EP-430

Section 5: Management Commitment

5.1 Quality Management System Management Commitment

Top Management has been actively involved in implementing the AS 9100 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.
▪        Establish quality objectives
▪        Establish the quality policy.
▪        Conduct management reviews.
▪        Ensure the availability of resources.

5.2 Customer focus

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). 

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."

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 in AP-501.

5.4 Planning

  5.4.1 Quality objectives

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.

Current Company level Quality Objectives are stated in attachment AP-501.

5.4.2 Quality management system planning

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. 

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

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.

5.5.2 Management representative

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.
▪        Promote awareness of customer requirements throughout the organization.
▪        Act as a liaison with external parties such as customers or auditors on matters relating to the QMS and
▪        Resolve matters pertaining to quality issues
Organizational freedom to resolve matters pertaining to quality.

5.5.3 Internal communication

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.

5.6 Management review

5.6.1 General

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.

5.6.2 Review input

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

        Results of audits
        Customer feedback
        Process performance and product conformity
        Company level quality data
        Status of preventive and corrective actions
        Follow-up actions from previous management reviews
        Planned changes that could affect the quality management system
        Recommendations for improvement

5.6.3 Review output

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
        Improvement of product related to customer requirements
        Resource needs

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.

Related Procedures:

Customer Related Processes                         SP-720
Management Responsibility                                 AP-500
Planning of Product Realization Processes                MP-710

Section 6: Resource Management

6.1 Provision of resources

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.

6.2 Human resources

6.2.1 General

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.

6.2.2 Competence, awareness and training

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.

6.3 Infrastructure

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.

6.4 Work Environment

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.

Related Documents

Competence, Awareness and Training         AP-622
Infrastructure                                         EP-630

Section 7: Planning and Product Realization

7.1 Planning of product realization

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 quality objectives and requirements for the product,
▪        Processes, documentation and resources required
▪        Verification, validation, monitoring, inspection and test requirements, and
▪        Criteria for product acceptance
▪        Resources necessary to support operation and maintenance of the product
▪                Resources to support operation and maintenance of the product.

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

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

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

▪ Requested by the customer
▪ Required for delivery and post-delivery activities
▪ Not stated by the customer but necessary for specified use or known and intended use
▪ Statutory and regulatory requirements related to the product
▪ Additional requirements determined by CNC Dynamics

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

7.2.2 Review of requirements related to the product

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:

▪ Product requirements are defined
▪ Contract or order requirements differing from those previously expressed are resolved
▪ CNC Dynamics has the ability to meet the defined requirements
▪ 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.

7.2.3 Customer communication

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

▪ Product Information
▪ Enquiries, contracts and order handling, including amendments
▪ Customer Feedback, including customer complaints

7.3 Design and Development

7.3.1 Design and development planning

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
▪ Responsibilities and authorities for design and development.
▪ Where appropriate, due to complexity, the organization gives consideration to the following activities:

Structuring the design effort into significant elements;
                2.         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
▪ Responsibilities and authorities for design and development
▪ Identification of the technical interfaces required for the project
▪ Updating of the design plan as the project progresses
▪ 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.

7.3.2 Design and development inputs

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:
  • Functional and performance requirements
  • Applicable statutory and regulatory requirements
  • Where applicable, information derived from previous similar designs
  • Other requirements essential for design and development

7.3.3 Design and development outputs

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:

▪ Meet the input requirements
▪ Provide appropriate information for purchasing, production and for service provision
▪ Contain or reference product acceptance criteria
▪ 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).

7.3.4 Design and development review

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
▪ Identify any problems and propose necessary actions
▪ Include representatives of functions concerned with the design and development stage being reviewed
to authorize progression to the next stage.

7.3.5 Design and development verification

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).

7.3.6 Design and development validation

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. Documentation of Design and/or Development Verification and Validation

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. Design and/or Development Verification and Validation Testing:

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 correct configuration standard of the product is submitted for the test
▪ The requirements of the test plan and the test procedures are observed
▪ The acceptance criteria are met

7.3.7 Control of design and development changes

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.

7.4 Purchasing

7.4.1 Purchasing process

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.

7.4.2 Purchasing information

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

▪ Requirements for approval of product, processes and equipment
▪ Requirements for qualification of personnel
▪ 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.

7.4.3 Verification of purchased product

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

7.5 Production and Service Provision

7.5.1 Control of production and service provision

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
Special processes (see 7.5.2).

Controlled conditions include, as applicable:

▪ The availability of information that describes the characteristics of the product
▪ The availability of work instructions
▪ The use of suitable equipment
▪ The availability and use of monitoring and measuring devices
▪ The implementation of monitoring and measurement
▪ The implementation of release, delivery and post-delivery activities
▪ Accountability for all product during manufacture (e.g., parts quantities, split orders, nonconforming product), part accountability to ensure bad parts have been destroyed
▪ E
vidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized,
▪ Provision for the prevention, detection, and removal of foreign objects,
▪ Monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product quality, and criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations). Production Documentation

Production operations are carried out in accordance with approved data. This data contains as necessary:

▪ Drawings, parts lists, process flow charts including inspection operations, production documents and inspection documents
▪ A list of specific or non-specific tools and numerical control (NC) machine programs required and specific instructions associated with their use. Control of Production Process Changes:

Authorized people for approving changes to production processes are identified in the Procedure MP-750. CNC Dynamics identifies and obtains acceptance of changes that require customer or regulatory authority approval in accordance with contract or regulatory requirements. Changes affecting processes, production equipment, tools and programs are documented and procedures are available to control the implementation of changes.

The results of changes to production processes are assessed to confirm that the desired effect has been achieved without adverse effects to product quality. Control of Production Equipment, Tools and Numerical Control (N.C.) Machine Programs

Production equipment, tools and programs are validated prior to use and maintained and inspected periodically according to documented procedures. Validation prior to production use includes verification of the first article produced to the design data/specification. Storage requirements, including periodic preservation/condition checks, have been be established for production equipment or tooling in storage. Control of Work Transferred, on a Temporary Basis, Outside the Organization's Facilities

When planning to temporarily transfer work to a location outside the organization's facilities, the organization defines the process to control and validate the quality of the work. Control of Service Operations

Where servicing is a specified requirement, service operation processes provide for:

▪ A method of collecting and analyzing in-service data,
▪ Actions to be taken where problems are identified after delivery, including investigation, reporting activities, and actions on service information consistent with contractual and/or regulatory requirements,
▪ The control and updating of technical documentation,
▪ The approval, control, and use of repair schemes, and
▪ The controls required for off-site work

7.5.2 Validation of processes for production and service provision

CNC Dynamics validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results.

CNC Dynamics has documented the process for validation including:

▪ Defined criteria for review and approval of the processes, qualification and approval of special processes prior to use
▪ Approval of equipment and qualification of personnel
▪ Use of specific methods and procedures, 
▪ Control of the significant operations and parameters of special processes in accordance with documented process specifications and changes thereto
▪ Requirements for records
▪ Revalidation

7.5.3 Identification and traceability

CNC Dynamics identifies the product throughout product realization according to the Identification and Traceability procedure (MP-753).

▪ CNC Dynamics maintains the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration.
▪ Product is identified with respect to monitoring and measurement requirements.
▪ When acceptance authority media such as stamps, electronic signatures or passwords are used CNC Dynamics establishes and documents controls for the media.
▪ According to the level of traceability required by contract, regulatory, or other established requirement, CNC Dynamics system provides for:

o        Identification to be maintained throughout the product life;
o        All the products manufactured from the same batch of raw material or from the same manufacturing batch to be traced, as well as the destination (delivery, scrap) of all products of the same batch;
o        For an assembly, the identity of its components and those of the next higher assembly to be traced;
o        For a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved.

CNC Dynamics controls and records the unique identification of the product where ever traceability is a specified requirement

7.5.4 Customer property

CNC Dynamics exercises care with customer property while it is under the organization's control or being used. A procedure (MP-754) outlines the Identification, verification, protection and safeguarding of customer property provided for use. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records maintained.

7.5.5 Preservation of product

CNC Dynamics preserves the conformity of product during internal processing and delivery to the intended destination per procedure (MP-755). This preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product.

Preservation of product also includes, where applicable in accordance with product specifications and/or applicable regulations, provisions for:

▪ Cleaning;
▪ Prevention, detection and removal of foreign objects;
▪ Special handling and packaging for sensitive products;
▪ Marking and labeling including safety warnings;
▪ Shelf life control and stock rotation;
▪ Special handling for hazardous materials.

The organization ensures that documents required by the contract or order to accompany the product are present at delivery and are protected against loss and deterioration.

7.6 Control of monitoring and measuring devices

CNC Dynamics has determined the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. A documented procedure (QP-760) outlines the process used to ensure that monitoring and measurement to be carried out are carried out in a manner that is consistent with the monitoring and measurement requirements.

▪ Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.
▪ Adjusted or re-adjusted as necessary
▪ Identified to enable the calibration status to be determined
▪ Safeguarded from adjustments that would invalidate the measurement result
▪ Protected from damage and deterioration during handling, maintenance and storage
▪ Be recalled according to a defined method when requiring calibration

In addition, Quality Control assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. CNC Dynamics takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained

CNC Dynamics maintains a register of these monitoring and measuring devices. The process used for their calibration is defined in procedures, work instructions and equipment manuals and includes details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria.

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is undertaken prior to initial use and reconfirmed as necessary.

CNC Dynamics ensures that environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out.

Related Documents

Planning of Product Realization Processes MP-710
Customer Related Processes SP-720
Design and Development EP-730
Purchasing AP-740
Control of Production and Service Provision MP-750
Identification and Traceability MP-753
Preservation of Product MP-755
Control of Monitoring and Measuring Devices QP-760

Section 8: Measurement, Analysis and Improvement

8.1 Measurement, Analysis and Improvement, General:

CNC Dynamics plans and implements the monitoring, measurement, analysis and improvement processes as needed

▪ To demonstrate conformity of the product,
▪ To ensure conformity of the quality management system, and
▪ To continually improve the effectiveness of the quality management system.

These processes are identified in documented procedures and include determination of applicable methods, including statistical techniques, and the extent of their use.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

As one of the measurements of the performance of the quality management system, CNC Dynamics monitors information relating to customer perception as to whether the organization has fulfilled customer requirements. The method for obtaining and using this information is identified in the Customer Related Processes (SP-720) and the Management Responsibility procedures (AP-500).

8.2.2 Internal Audit

CNC Dynamics conducts internal audits at planned intervals to determine whether the quality management system

▪ Conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization
▪ Is effectively implemented and maintained.

An audit program has been designed and implemented and identifies an audit schedule based on the importance of the areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency, methods, responsibilities and requirements for planning and conducting audits, and for reporting and maintaining results, are defined and documented in the Internal Audit procedure (QP-822).

The management responsible for the area being audited is responsible for ensuring that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results.

Detailed tools and techniques such as checksheets, process flowcharts, or any similar method to support audit of the quality management system requirements are developed, maintained and used according to the Internal Audit Procedure (QP-822). The acceptability of the selected tools is measured against the effectiveness of the internal audit process and overall organization performance.

Internal audits meet contract and/or regulatory requirements.

8.2.3 Monitoring and measurement of processes

CNC Dynamics applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product.
In the event of process nonconformity, the organization:

▪ Takes appropriate action to correct the nonconforming process,
▪ Evaluates whether the process nonconformity has resulted in product nonconformity, and
▪ Identifies and controls the nonconforming product in accordance with clause 8.3.

The process for identifying and carrying out the required monitoring and measuring of processes is documented in the Monitoring, Measuring and Analysis of Product Realization Processes (MP-824) and Management Responsibility procedures (AP-500).

8.2.4 Monitoring and measurement of product

CNC Dynamics monitors and measures the characteristics of the product to verify that product requirements are fulfilled. This is carried out at appropriate stages of the product realization process identified in Monitoring, Measuring and Analysis of Product Realization Processes (MP-824).

Evidence of conformity with the acceptance criteria is maintained. Records indicate the person authorizing release of product. Product release and service delivery does not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer.

When key characteristics have been identified, they are monitored and controlled.

When the organization uses sampling inspection as a means of product acceptance, the plan is statistically valid and appropriate for use. The plan precludes the acceptance of lots whose samples have known nonconformities. When required, the plan is submitted for customer approval.

Product is not used until it has been inspected or otherwise verified as conforming to specified requirements, except when product is released under positive-recall procedures pending completion of all required measurement and monitoring activities. Inspection Documentation

Measurement requirements for product or service acceptance are documented. This documentation is part of the production documentation, and includes:

▪ Criteria for acceptance and/or rejection,
▪ Where in the sequence measurement and testing operations are performed,
▪ A record of the measurement results, and
▪ Type of measurement instruments required and any specific instructions associated with their use.
▪ Test records shall show actual test results data when required by specification or acceptance test plan.
▪ Where required to demonstrate product qualification the organization shall ensure that records provide evidence that the product meets the defined requirements. First Article Inspection

The organization's system shall provide a process for the inspection, verification, and documentation of a representative item from the first production run of a new part, or following any subsequent change that invalidates the previous first article inspection result.

8.3 Control of Nonconforming Product

CNC Dynamics ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in the Control of Nonconforming Product procedure (QP-830).

The organization does not use dispositions of use-as-is or repair, unless specifically authorized by the customer, if

▪ The product is produced to customer design, or
▪ The nonconformity results in a departure from the contract requirements.

Unless otherwise restricted in the contract, organization-designed product which is controlled via a customer specification may be dispositioned by CNC Dynamics as use-as-is or repair, provided the nonconformity does not result in a departure from customer-specified requirements.

Product dispositioned for scrap is conspicuously and permanently marked, or positively controlled, until physically rendered unusable.

In addition to any contract or regulatory authority reporting requirements, CNC Dynamics system provides for timely reporting of delivered nonconforming product that may affect reliability or safety. Notification includes a clear description of the nonconformity, which includes as necessary parts affected, customer and/or organization part numbers, quantity, and date(s) delivered.

The term "nonconforming product" includes nonconforming product returned from a customer.

Responsibility for review and authority for the disposition of nonconforming product and the process for approving personnel making these decisions is defined in the procedure.

8.4 Analysis of Data

CNC Dynamics determines, collects and analyses appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the quality management system can be made. The process for determining, collecting and analyzing this data is defined in the Management Responsibility procedure (AP-500). Appropriate data includes data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data provides information relating to:

▪ Customer satisfaction
▪ Conformance to product requirements
▪ Characteristics and trends of processes and products including opportunities for preventive action
▪ Suppliers

8.5 Improvement

8.5.1 Continual improvement

CNC Dynamics continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

8.5.2 Corrective action

CNC Dynamics takes action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered.

A documented procedure (QP-852) defines requirements for

▪ Reviewing nonconformities (including customer complaints),
▪ Determining the causes of nonconformities,
▪ Evaluating the need for action to ensure that nonconformities do not recur,
▪ Determining and implementing action needed,
▪ Records of the results of action taken (see 4.2.4), and
▪ Reviewing corrective action taken.
▪ Flow down of the corrective action requirement to a supplier, when it is determined that the supplier is responsible for the root cause, and specific actions where timely and/or effective corrective actions are not achieved.

8.5.3 Preventive action

CNC Dynamics determines action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems.

A documented procedure (QP-853) defines requirements for:

▪ Determining potential nonconformities and their causes
▪ Evaluating the need for action to prevent occurrence of nonconformities
▪ Determining and implementing action needed
▪ Records of results of action taken
▪ Reviewing preventive action taken

Related Documents

Management Responsibility AP-500
Customer Related Processes SP-720
Monitoring, Measuring and Analysis of Customer Satisfaction AP-821
Internal Audits QP-822
Monitoring and Measuring of Product and Realization Processes MP-824
Control of Nonconforming Product QP-830
Corrective Action QP-852
Preventive Action QP-853
Statistical Techniques QP-840

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