QUALITY POLICY MANUAL
1.0 Scope
This quality management system (QMS) manual has been prepared as a guide for all associates of the Company,
Incorporated organization. The QMS is designed in accordance with ISO 9001, and although some of the QMS
processes may be applied to other products, the scope of this manual and of ISO 9001 compliance is applicable only
to products produced for the aerospace/defense industry. Additionally the ISO standard pertaining to Design and
Development (sec. 7.3) is excluded from this manual. All Company associates shall adhere to the policies and
procedures set-forth in this manual.
2.0 References
This manual is designed to create a QMS which meets the operational requirements of the ISO 9001:2000 Standard.
The content of the ISO standard is therefore not repeated verbatim in this manual; the reader may instead refer to the
ISO standard in order to understand the correlation between the two documents.
3.0 Company Background
Company (COMPANY) was established in 1957. COMPANY operates from facilities located at ***********in *********.
COMPANY is a world class supplier in a global market specializing in the production of precision-machined products
for the defense, aerospace, textile, automotive, and extruder industry. COMPANY utilizes state of the art technology,
processes, and machining practices for production of products that meet or exceed customer requirements and
expectations.
4.0 Quality Management System
4.1 General
The organization has defined, documented, and implemented a QMS consisting of policies and objectives, processes
and procedures, and measurements. Interaction of the components of the QMS is understood, and the system is
monitored to determine the extent to which customer requirements are met, and to continually improve when possible
any and all facets of the business.
4.2 Documentation
4.2.1 General
Due to the size of the organization and capability of the employees, documentation of Company’s QMS is designed
to minimize size and complexity. The system is therefore two-tiered, consisting of this manual, supported by all other
documentation (e.g., forms, necessary instructions).
4.2.2 Quality Manual
The required policies and procedures included in this manual are for the satisfaction of our customers and are
organized to parallel with the ISO 9001 standard. All associates are required to be aware of the manual’s existence
and familiar with the components that directly affect their ability to perform their work and to improve it. A process
map defines the key processes and interrelationships of the QMS (See Attachment A)
1
QUALITY POLICY MANUAL
4.2.3 Controlled Documents
All internal and external quality related documents are controlled, including review and approval of originals and
revisions, issuance to proper locations, and obsolete copies. Any employee may recommend the creation or revision
of a document, and may do so through a review with a member of management. A master list of controlled
documents is maintained (QAF-4.2C), as well as a log of document changes (QAF-4.2B). A Document on the master
list is considered an approved document. Documents are reviewed as part of the internal audit process to evaluate
their continued legibility. Following is the process for controlling each type of document.
Document Type
Quality manual
Approved By
Issue Locations
Multiple
QAIs (instructions)
President
Quality Manager
User and their manager
QAFs (forms)
User and their manager
Point of use
ISO & Mil standards
Customer Drawings
QA Manager
Sales
Quality Assurance
Sales
Quality Assurance
Programming/
Engineering
Quality Assurance
QA Manager’s Office
Plant
Superintendent
Plant
Superintendent
Point of Use
Customer Specs
CNC Programs
Point of use
Obsoletes
Retain 1 copy of all
editions in obsolete file
Retain 1 most recent
copy in obsolete file
Retain 1 most recent
copy in obsolete file
shred
shred
Retain 1 most recent
copy in obsolete file
Retain 1 most recent
copy in obsolete file
4.2.4 Records Retention
Records of product and QMS performance are maintained, and are legible, identifiable and retrievable. The records
are available to customers when required by purchase order. A list of quality records is maintained (see Attachment
B) and indicates the type of record, who is to maintain each and for how long, where they are to be kept, and what
will be done when the retention time has expired. Retention time is based on customer requirements or as by
deemed necessary by management.
5.0 Management Responsibility
5.1 Management Commitment
Management of COMPANY ensures that employees are aware of the importance of meeting all requirements,
whether customer, regulatory or others. This is done by establishing and communicating:
1. The quality policy and objectives.
2. A QMS and resources to carry it out.
3. Reviewing performance.
5.2 Customer Focus
Customer requirements are determined as part of the contracting process, and compliance measured through
internal quality measures as well as customer feedback.
5.3 Quality Policy
2
QUALITY POLICY MANUAL
Management of COMPANY has defined and communicated the following quality statement throughout the
organization.
*************** provides precision machining services to the defense, textile, and commercial industries. Our goal is
to provide our customers with a quality, value added product, on time, every time with no defects. We will strive to
continually improve and evaluate our management, quality, and manufacturing processes. This will insure ongoing
customer satisfaction, and our success.
All associates understand this policy and how it relates to their work activities.
5.4 Planning
5.4.1 Quality Objectives
Measurable quality objectives are established and documented as part of the management review process (see 5.6)
and QMS planning (see 5.4.2) and communicated (see 5.5.3).
5.4.2 Quality Management System Planning
Quality planning is carried out at two levels: 1) planning of the QMS, which takes place through management reviews
and as part of the quality manager’s responsibilities, and 2) planning of product quality, which takes place as part of
planning for product realization (see 7.2). Integrity of the QMS is maintained when changes occur through control of
documents, training of personnel, and monitoring of QMS performance.
5.5 Responsibility, Authority, & Communication
5.5.1 Responsibility & Authority
Responsibility and authority is communicated to all personnel through:
1.
2.
3.
4.
An organizational chart.
This manual.
Associated instructions.
Job orientation and training.
A responsibility matrix correlating the organizational chart and components of the QMS is included in Appendix B of
this manual.
5.5.2 Management Representative
The Quality Assurance (QA) Manager is responsible for implementing and maintaining the QMS, monitoring its
performance, and reporting to management any needs for improvement. The Quality Manager will also ensure that
customer requirements are understood throughout the organization.
5.5.3 Internal Communication
Company communicates the effectiveness of the quality management system as part of a meeting of the President
with employees at least twice per year.
5.6 Management Review
3
QUALITY POLICY MANUAL
5.6.1 General
Management of COMPANY reviews performance of the QMS every six months according to Appendix C, which
becomes the record of the review.
6.0 Resource Management
6.1 Provision Of Resources
Resources required for product realization, implementing and improving the QMS, and for meeting customer
requirements are provided. This includes facilities, equipment, personnel, and knowledge.
6.2 Human Resources
6.2.1 General
Due to the types of production processes involved at COMPANY, the organization places a high emphasis on
associate knowledge rather than procedures and work instructions.
6.2.2 Competence, Awareness, & Training
Employees are selected based on their previous experience, training, and/or education, which is documented
through the employment application and training form(QAF-6.2A). New associates receive COMPANY positionspecific training by working with an associate who is experienced in that position and who will determine when the
new associate is fully qualified. The training form is also used to review each associate at least bi-annually to identify
additional training/development needs or opportunities. A competency spreadsheet is used to record which
individuals are qualified for which positions/jobs in the organization.
6.3 Infrastructure
COMPANY provides and maintains an infrastructure that will enable production of product according to requirements.
The infrastructure includes buildings, workspace, processing equipment, and support services. In order to maintain
security, the facility is within the confines of a security fence.
6.4 Work Environment
The work environment (e.g., layout, cleanliness, lighting & temperature) is maintained in such a manner that will not
allow situations contributing to product quality problems to occur. This includes temperature control of approximately
65-75 degrees F, and extensive electrical surge protection for production and engineering equipment.
7.0 Production
7.1 Planning of Products & Processes
4
QUALITY POLICY MANUAL
Planning for new products or processes is carried out and includes ensuring availability of product drawings and
specifications, resources (e.g., production and inspection equipment, human resources, raw materials, & outsourced
process suppliers), operating methods (instructions, training), and validation, inspection, and record requirements.
A key output of the planning process used to route each order through the realization process is an Operation Sheet
(see QAF 7.1) which specifies: Job number, customer, drawing number, part number, part description, material
requirements, order quantity, and a detailed list of processing and inspection operations and a description of each.
The Vice-President creates the operation sheets for the aerospace/defense orders, which are then given to the PlantFloor Superintendent to determine CNC programming requirements and operations that require external processes.
The Engineering Department provides and maintains the required NC programs, and the Quality Assurance
Department identifies sources for external processing.
7.2 Customer Related Processes
7.2.1 Determining Product Requirements
During the job quoting process, COMPANY gathers information regarding customer requirements and a quote is
generated by the Vice President.
7.2.2 Review of Orders
When an order is received it is reviewed, documented, and converted to a production order according to QAI 7.2.
Each order is entered into a job record logbook. The order review ensures that the product is adequately defined, the
order agrees with the quote, and the job requirements can be met. If an order is subsequently changed, the
documentation is reviewed/changed and personnel are made aware of the changes. Approved orders are stamped
and initialed.
7.2.3 Customer Communications
Effective communications are established with customers during the quoting process (see 7.2.1), the order handling
process (see 7.2.2), and customer feedback, including both customer satisfaction (see 8.2.2) and customer
complaints (see 8.5.2).
7.3 Design & Development
*********** works to customer drawings and specifications and is not design responsible. This element of the ISO
9001 standard is therefore excluded.
7.4 Purchasing
7.4.1 Supplier Management
COMPANY purchases quality related items such as raw metals (e.g., steel, titanium etc..), tooling, subcontracted
processing (e.g., painting, welding). Suppliers are selected by management based on their ability to meet quality
requirementsand specifications outlined by our customers. Due to specific material requirements and the complexity
of obtaining certain materials, the Vice-President and Quality approves suppliers based on their ability to meet
customer requirements and provide traceability. Materials and services will not be accepted without proper
certifications.
Supplier performance is reviewed as part of the management review process (see 5.6). Suppliers failing to meet the
requirements imposed by COMPANY may be placed on probation for a period of time to be determined by
COMPANY, or revocation of approved supplier status may be imposed.
5
QUALITY POLICY MANUAL
A supplier placed on probation is monitored by COMPANY management until supplier status is reinstated or supplier
status is revoked.
Any significant day-to-day problems that may occur with a supplier are handled through the Supplier Corrective
Action Response form (QAF-7.4B). Purchasing and Quality Assurance will notify the supplier and track the corrective
action process. A log of Supplier Corrective Action Reports (QAF-7.4C) is maintained to allow monitoring of trends in
supplier performance.
7.4.2 Purchase Orders
Suppliers are provided with appropriate drawings, specifications, and other requirements. Purchase orders may be
generated manually or through the computer system, and contain quantity, type, class/grade of goods, services
purchased, as well as any special requirements (e.g., material or process certifications, source inspections,
packaging requirements). Purchase orders are reviewed by Purchasing, QA, and Production for adequacy as
appropriate.
7.4.3 Verifying Purchased Product
Company verifies that all purchased products meet or exceed specified customer requirements. This will be
accomplished through receiving inspection or any other means necessary. QAI-7.4 is used to guide the receiving
process.
If a situation arises that stipulates or necessitates verification at supplier’s location, verification arrangements and
method of product release shall be stated in purchasing information.
7.5 Production
7.5.1 Control of Production
Production is carried out under controlled conditions including provision of product drawings, operation sheets
describing the work to be done, use of processing equipment capable of meeting product requirements, and control
of processing equipment and inspection of product with calibrated devices. First piece inspection is carried out at
each operation, with sign-off by both the operator and quality assurance personnel on the operation sheet. The first
piece is tagged and maintained until the job is completed. The general sequence used at each operation consists
of::
Receive Material
From Previous
Process
Review Drawing
and Operation
Sheet
First Piece
Run
Get First Piece
Approval from
QA
Set Up
Machine
Complete
Order at
Operation
Production equipment is maintained through a preventive maintenance program which involves shutting down machines one day
per month (typically the 1st Monday of each month). Maintenance requirements are defined in the equipment manual or by
6
QUALITY POLICY MANUAL
COMPANY for each machine, and performance of the maintenance is recorded on QAF 7.5.1. A record of breakdown
maintenance is also maintained.
7.5.2 Validation of Production Processes
COMPANY currently performs no processes that cannot be verified by subsequent inspection of the product. If such processes
were to be used, the organization would provide appropriate personnel, equipment, or subcontracted services to ensure that
product requirements would be met.
7.5.3 Product Identification & Traceability
The operation sheet documents the inspection status of each order as it moves through the sequence of operations. Each order
is traceable back to raw material, machine, and operator. Each part is laser etched to provide traceability.
Tags or other markings are used to identify material. An identification tag is used to mark received/accepted material as well as
outgoing material. A Reject tag (QMT-121P) is used for rejected material that cannot immediately be scrapped. A special
instruction tag (QMT-214P) is used to document rework instructions. A scrap tag (QMT-222P) is used to mark material that is to
be physically scrapped.
7.5.4 Control of Customer Owned Property
COMPANY exercises care of customer property (material, tooling, and inspection devices, etc..) while in the possession of
COMPANY. Upon receipt of customer property, it is inspected for:
1.
2.
3.
4.
Prior damage or missing components.
Verification of quantity.
Identification to ensure proper use.
Functional testing if applicable.
The material is checked once again prior to or during use if there are concerns about the impact on product quality. If for any
reason customer property is lost, damaged, or otherwise found unsuitable for use, the customer is notified and records
maintained.
7.5.5 Handling, Storage, Packing, & Delivery
COMPANY ensures that product, materials, and components are preserved during internal processing and delivery to customer ,
including proper identification, handling, packaging, storage, and protection. Specific controls include:
A) Time sensitive material will be confirmed to be within the proper date before use.
B) Customer orders will not be shipped until all shipping papers are identified, signed, and dated.
C) No material is shipped until required certifications, test reports, special samples, etc. have been packed with the material in
accordance with customer requirements.
D) All items will be packaged in a manner that prevents damage, deterioration, or substitution.
E) Adequate identification markings appear on packaging and components as necessary to provide correct product identification
to the customer.
F) Any required special packaging will be controlled as specified by the customer.
Shipping operates in accordance with the Receiving/Shipping Instruction QAI-7.4.
7.6 Calibration
Devices used for product inspection/testing, control of critical process parameters, or calibration of such devices, are
periodically calibrated or otherwise verified as suitable for use by either internal personnel or external calibration
7
QUALITY POLICY MANUAL
sources. This includes customer owned devices unless the customer retains calibration responsibility. All devices to
be calibrated are documented in the Gagepack software, along with guidelines for frequency of calibration for each
type of device.
All calibrations are performed within three (3) days of the due date in accordance with written instructions (QAI 7.6) or
manufacture’s guidelines.All calibrations are traceable to NIST. Each instrument or device will be assigned a unique
identification number for traceability, which is permanently affixed to the instrument and recorded electronically in the
Gagepack software.
All instruments are stored and maintained so as to prevent damage that would cause measurement results to be
invalid. The environment in which calibrations are performed is maintained at 68-72 degrees F, and relative humidity
of 40-60%. The inspection/calibration lab is also isolated from vibration.
Records of calibration are maintained including any equipment found to be out of calibration tolerance. Records of
calibration performed internally and externally are maintained in the GagePack calibration software. Labels are
affixed to each device to indicate the calibration status.
All first piece inspection and final product inspections are performed with calibrated devices. Machine personnel are
allowed to use their own gages for in-process checks. These gages are not included in the calibration system, but
may be calibrated if the employee requests it. In such cases a record of calibration is not maintained, and a
calibration label is not affixed to the gage.
Any product affected by a device found to be out of tolerance either in house or delivered to the customer shall be
evaluated and appropriate action taken. Documentation of the investigation of the device and product, and any action
taken to prevent recurrence will be treated and documented as a corrective action (see 8.5.2).
The Quality Assurance Manager oversees the calibration process, which is operated in compliance with MIL-STD45662.
8.0 Measuring & Improving Products & Processes
8.1 General
COMPANY collects and analyzes data that enables evaluation of product and QMS performance. Analysis may take
the form of discrete decisions (e.g., good or bad), or of looking for trends using tools such as Pareto diagrams, run
charts, or statistical techniques. The resulting information allows reacting to problems as well as continual
improvement of the QMS.
8.2 Monitoring & Measuring
8.2.1 Customer Satisfaction
Major customers provide periodic feedback on COMPANY performance. This information is reviewed during
management review (see 5.6) to determine the level of customer satisfaction. As part of the management review
8
QUALITY POLICY MANUAL
process the management team may also elect to solicit additional information, or similar information from other
customers either
through face-to-face meetings or phone discussions. When completed, the core information received from these
communications will be documented.
8.2.2 Internal Audits
COMPANY plans and conducts internal quality audits as one measure of the effectiveness of the QMS. These
audits cover the requirements of ISO9001:2000 and internal policies and procedures. Audits are performed based
on an audit schedule (QAF-8.2D) that considers the risk and performance of the processes being audited.
The Quality Assurance Manager or others with delegated authority will identify qualified auditors for each audit. The
selection process will consider factors such as training, objectivity, and impartiality. Auditors will review appropriate
documentation (e.g., the ISO standard, quality manual, instructions, forms, etc. and determine what evidence (verbal,
observation, records, etc.) will be requested during the audit. No specific audit checklist is required.
An Internal Audit Report (QAF-8.2B) will be completed by the auditor(s), documenting what areas were audited and
what findings, if any, were noted. The Quality Assurance Manager will determine whether non-conformances require
an official corrective action or whether the finding does not require a full-scale investigation of root cause.
Corrective actions will be handled according to the Corrective Action Report process (see 8.5.2), and future audits
will confirm the effectiveness of actions taken. Audits will not be closed out until all related Corrective Action Reports
have been effectively addressed.
8.2.3 Monitoring & Measurement of Processes
QMS processes that are closely related to achieving quality objectives are monitored. Examples include equipment
downtime, on-time delivery, and product quality (e.g., rework and scrap). The audit process also monitors QMS
processes for compliance.
8.2.4 Monitoring & Measurement of Product
COMPANY measures key characteristics of the product to ensure that customer requirements are met. The product
is measured according to the operation sheet (QAF-7.1) and/or drawing for each order. Inspection personnel use a
unique inspection stamp which is issued and logged by the Quality Assurance Manager. The operation sheet
documents the personnel performing inspections. Records of inspection are maintained to demonstrate product
compliance and noncompliance.
8.3 Control of Nonconforming Product
Product that does not meet requirements will be permanently marked or tagged with a Reject Tag (QMT-121P) and
segregated from conforming product. The nonconformity is reported to the Quality Assurance Manager for review,
the Quality Assurance Manager will then authorize to scrap or designate rework. The disposition will be recorded on
the Operation Sheet. If parts are to be scrapped, they will be tagged with the Scrap Tag (QMT-222P) until physically
scrapped. Customer approval for scrap is required in the instance of customer supplied material.
When the QA Manager cannot make a decision, the problem will be documented on the Nonconforming Product
Form (QAF-8.3). The Quality Assurance Manager will call a meeting of the Material Review Board (MRB), consisting
of the Quality Assurance Manager, Vice-President, and Production Manager. The MRB must be unanimous in their
decision, which may be to either rework the material or to submit it to the customer for disposition. The decision will
be documented on QAF-8.3.
If product is reworked, it will be re-inspected according to the original specifications. If a potential product
nonconformity is detected after delivery of the product to the customer, the customer will be notified of the potential
9
QUALITY POLICY MANUAL
problem. Customer returned product is handled according to the Receiving (7.4.3), Nonconforming Material (8.3)
and Corrective Action (8.5.2) processes.
Some nonconforming material may be retained for use as machine set-up components. In such cases, the material
will be clearly marked as nonconforming, and retained in a way as to indicate the proper use.
8.4 Analysis of Data
COMPANY analyzes data such as customer satisfaction, customer complaints, product conformity results, process
conformity results (e.g., audits and other process measures), and supplier performance in order to evaluate the
effectiveness of the QMS (see 5.6)
8.5 Improvement
8.5.1 Continual Improvement
COMPANY strives to continuously improve performance of the organization through alignment and changes to the
quality policy and objectives, product and process results, and other metrics. Although day-to-day improvements are
made, the management review process is used for long-term evaluation and direction (see 5.6).
8.5.2 Corrective Action
A corrective action process has been implemented to address failures of the QMS. Such failures might be indicated
by customers (e.g., complaints, returned product), by audits (internal or external), by internal nonconforming product,
or other process failures (e.g., calibration). Any associate may initiate a Corrective Action Report for customerrelated problems. Corrective Action Reports for audits are initiated by the Quality Assurance Manager. For internal
nonconforming product, Corrective Action Reports are initiated by the MRB. Any manager may initiate a Corrective
Action Report for a process failure. The management review process may also initiate a Corrective Action Report for
any issue. QAF-8.5.2B is used to initiate a Corrective Action Report.
Corrective Action Reports are first sent to the Quality Assurance Manager for logging of the document (QAF-8.5.2A)
and determination of responsibility for the Corrective Action Report. The responsible associate must then perform
root cause analysis to indicate what actions will be taken to prevent reoccurrence. A copy of the form is then
returned to the Quality Assurance Manager, who reviews it for adequacy of root cause analysis and action planning.
Once the actions have been taken, the responsible associate will notify the Quality Assurance Manager of the
Corrective Action Report’s completion. The Quality Assurance Manager will then perform or assign responsibility for
follow-up to evaluate effectiveness of the action. The effective data of each Corrective Action Report is documented.
8.5.3 Preventive Action
Preventive action is initiated to offset potential failures that have not yet occurred. It is done through:
10
QUALITY POLICY MANUAL
A) Planning for new products/processes (see 7.1). Consideration is taken of potential problems that might occur
during production, and to pre-plan the process so as to reduce the probability of occurrence.
B) Trending of Corrective Action Reports which may be indicated by analysis of QAF-8.5.2A. Performed by the
Quality Assurance Manager prior to each management review.
C) The management review process, which takes a more systemic view of the QMS, identifying possible
interrelationships of processes and organizational changes.
Preventive actions are documented on the same form as the Corrective Action Report, following the same sequence
of issuance, analysis, action, and follow-up (see 8.5.2).
11