CNC Dynamics developed and implemented a
Quality Management System in order to document thecompany’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.
David T. Daum, President / CEO: (Signature on File)
Quality
Manual Distribution
A
controlled copy of the Quality Management System distributed to the following
individuals:
President
/ CEO,
Marketing
Manager,
Engineering
Manager,
Quality
Manager,
Production
Manager
Administrative
Manager,
Quality
Inspector,
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:
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.
1.2 Application
CNC
Dynamics has determined that no AS9100
exclusions are applicable to the operations of this company.
Section
2: Normative Reference
2.0 Quality Management System References
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
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.
▪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.
4.1 General requirements
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.
To design and implement the
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 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 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
4.2 Documentation Requirements
4.2.1 General
The QMS documentation
includes:
▪A documented Quality Policy
▪This Quality 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 Quality manual
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.
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.
Related Procedures
Document ControlAP-423
Control of Quality RecordsAP-424
Configuration ManagementEP-430
5.1 Management commitment
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.
▪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 on 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 A-500-002.
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 ResponsibilityAP-500
Planning of Product
Realization ProcessesMP-710
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
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
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:
ŘStructuring the design
effort into significant elements;
ŘFor 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.
7.3.6.1 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.
7.3.6.2 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
▪evidence 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).
7.5.1.1 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 num
eric
al control (NC) machine programs required and specific instructions associated
with their use.
7.5.1.2 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.
7.5.1.3 Control of Production
Equipment, Tools and Num
eric
al 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.
7.5.1.4 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.
7.5.1.5 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:
oIdentification
to be maintained throughout the product life;
oAll
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;
oFor
an assembly, the identity of its components and those of the next higher
assembly to be traced;
oFor
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
8.1 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.
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.
8.2.4.1 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.
8.2.4.2 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
▪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