QS9000

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The document outlines the quality management system and policies of Brown Manufacturing Company to ensure compliance with QS-9000 and ISO 9002 standards.

The document describes the quality management system, policies, and documentation structure of Brown Manufacturing Company's quality system.

The main sections covered include management responsibility, quality system, contract review, design control, document control, and more as outlined in the table of contents.

QS 9000 Policy Manual

Brown Manufacturing Company, Inc.

Document Number: Revision: Issue Number:


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Table Of Contents
Section Page
Information Page 4

Introduction 5

Quality Policy 7

Organization 8

Requirements 9

4.1 Management Responsibility 9

4.2 Quality System 11

4.3 Contract Review 14

4.4 Design Control 16

4.5 Document and Data Control 17

4.6 Purchasing 19

4.7 Control of Customer Supplied Product 21

4.8 Product Identification and Traceability 22

4.9 Process Control 23

4.10 Inspection and Testing 26

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Table Of Contents (Continued)

4.11 Control of Inspection, Measuring and Test Equipment 28

4.12 Inspection and Test Status 30

4.13 Control of Nonconforming Product 31

4.14 Corrective and Preventive Action 33

4.15 Handling, Storage, Packaging, Preservation and Delivery 35

4.16 Control of Quality Records 37

4.17 Internal Quality Audits 39

4.18 Training 41

4.19 Servicing 42

4.20 Statistical Techniques 43

Customer 44

Glossary 44

Bibliography 56

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Document Title : QS 9000 Policy Manual

Document Number : QPM-201

Issuer : LES

Approved By :

Revision Number: 0.3

Revision Date : 1/11/00

Organization : Brown Manufacturing Company, Inc.

Organization Abbreviation : Brown Manufacturing

SIC Code : 3451

Address : 75 Northwest Drive


P.O. Box 459
Plainville CT 06062-0459

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Introduction
This quality manual describes the policies and company-wide control system for the
quality management system of Brown Manufacturing Company, Inc..
The quality system meets:

1. QS-9000 Quality System Requirements(Intro.1, 2)

2. The quality system meets ISO 9002:1994(e) -- Quality systems -- Model for
quality assurance in development and production.
Structure of the Quality System Documentation

The Quality System is documented in the following manner consistent with the
guidelines in ISO 10013, Guidance on Quality Manuals.

1. This document -- the Quality Policy Manual -- (Level I) defines overall


management commitment to the quality system and broad statements of
system components to achieve all elements of QS-9000.(Intro.1, Intro.9,
4.2.1) The quality policy manual is revised periodically to keep it up to date
and revisions issued as appropriate. All revisions to the manual are
recorded in the revision history. Obsolete copies of the manual are kept for
7 years.

2. Quality procedures (Level II) ensure that aspects of the Quality


Management System comply with the requirements of QS-9000. These
procedures are assigned the general prefix "QSP" (for Quality System
Procedure) and a reference number. In many cases, a QSP satisfies
requirements of several elements of QS 9000. This is shown in the QSP
under "Governing Element" and is reflected in the QS 9000 Element Check
Cross Reference report.

3. For most procedures, additional supporting instructions have been


established (Level III). Work Instructions have been assigned the general
prefix "QWI" (for Quality Work Instruction) and a reference number. They
are referenced in the QSP where applicable.

4. For most procedures, additional supporting record-keeping forms have been


established (Level IV). Record-keeping Forms have been assigned the
general prefix "QF" (for Quality Form) and a reference number. They are
referenced in the QSP where applicable.

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Introduction (Continued)

5. A Glossary is established to provide clear definitions of certain terms used


throughout this manual. The content of the Glossary is derived from ISO
8402 except where inconsistent terminology exists between ISO 8402 and
QS-9000. QS-9000 terminology will take precedence.

6. A cross reference defines the Quality System Procedures required to


implement each element of the policy. To simplify change control, this
information is maintained separately in the Policy Element Check Cross
Reference report.
Quality Policy Manual Translation

Any of the levels of quality policy documentation my be translated into other


languages in order to communicate the quality policy to all levels of the
organization. Should there be differences of interpretation of Brown Manufacturing
Company, Inc. policy arising out of such translations, the English language version
shall be the sole norm.
Overview
Brown Manufacturing Company, Inc. headquarters is located at:

75 Northwest Drive
P.O. Box 459
Plainville CT 06062-0459

Brown Manufacturing Company, Inc. manufactures precision products to customer


requirements and is classified under SIC Code 3451. The company was founded in
June of 1955.
Mission
Brown Manufacturing Company, Inc. Mission Statement:

We will produce precision products to satisfy or exceed our customers'


requirements.

Brown Manufacturing Company, Inc. Vision Statement:

We will be every customer's preferred supplier because of the quality of our


products and the pride and dedication of the members of our organization. Every
individual in our organization will have the opportunity for personal achievement.

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Quality Policy
Policy
We will work together continuously to improve our products and processes.
We will deliver to our customers defect-free products on time, every time.
Objectives
1. Maintain a strong Quality Policy emphasizing continuous improvement.

2. Provide a secure, safe and responsible work environment.

3. Operate with integrity.

4. Promote teamwork.

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Organization Structure
Brown Manufacturing Company, Inc. operates its production facilities at:

75 Northwest Drive
P.O. Box 459
Plainville CT 06062-0459

The senior executive of operation is the President and Chief Executive Officer.
Brown Manufacturing Company, Inc. maintains a written organization chart
designating positions and responsibilities of company officers, managers and
employees. Brown Manufacturing Company, Inc. operations are more fully
described below.

The Board of Directors has the ultimate authority in the management of the
company. The President and CEO of the company, as Chairman of the Board of
Directors, is the highest authority in the daily operation of the business. This officer
is also directly responsible for management of the Sales team.

The Sales Team directs the Marketing, Production Planning, Contract Review and
Customer Service departments.

The Executive Vice President has the responsibility for management of the
Quality Team. The Quality Team is responsible for the Quality Assurance and
Quality Control departments.

The Executive Vice President and Secretary/Treasurer share the responsibility


for the Administration Team which is responsible for the Information Services and
Human Resources departments.

The Operations Manager has the responsibility for management of the Operations
Team. The Operations Team directs the Production, Purchasing, Materials Control
and Facilities departments.

Organization References

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4.1 Management Responsibility


1. Policy
Brown Manufacturing Company, Inc. executive management establishes policy,
objectives and commitment to quality.
2. Key System Components
4.1.2.1. The Quality Policy is relevant to the organization's goals and is documented
along with the objectives and commitment to quality.(4.1.1)

4.1.2.2. The Quality Policy is communicated, understood, implemented and


maintained at all levels in the organization.(4.1.1)

4.1.2.3. The responsibility, authority, and the interrelationship of all personnel who
manage, perform, and verify work affecting quality is defined and
documented. Personnel responsible for quality have the same
organizational status as those responsible for production.(4.1.2.1)

4.1.2.4. In-house verification requirements are identified.

4.1.2.5. Responsibilities for quality improvement and problem prevention are


established.

4.1.2.6. Adequate resources are provided and trained personnel assigned for
prevention and verification activities, internal audits, as specified in
procedures and liaison with external parties as necessary. Rapid and
effective communication channels are provided to managers transmitting
information in a timely manner.(4.1.2.2).

4.1.2.7. Verification activities include inspection, testing and monitoring of production


of the product on a frequency as prescribed in procedures.

4.1.2.8. A Management Representative is appointed with defined authority for


ensuring the following:(4.1.2.3)

4.1.2.8.1. Implementation and maintenance of the quality system.

4.1.2.8.2. Reporting on the performance of the quality system to management.

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Key System Components (Continued)

4.1.2.9. Quality responsibilities are allocated on all shifts and the quality function is
tasked with representing the customer internally.

4.1.2.10. Quality System effectiveness is monitored and reviewed using a


multi-disciplinary approach by executive management as a basis for
improvement. It is documented through the Management Review procedure
which ensures the review covers all the elements of the entire quality
system and review records are maintained.(4.1.3)

4.1.2.11. The business is operated with the aid of measurement and with the
implementation of constant improvement.

4.1.2.12. Customer satisfaction is measured and improved. Records are maintained.

4.1.2.13. Authorities for Management Responsibility are identified in procedures.

3. Responsibility
CEO Chief Executive Officer
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
BUSINESS PLANNING QSP-4.01.203

CUSTOMER SATISFACTION MEASUREMENT QSP-4.01.204

ECONOMICS OF QUALITY QSP-4.01.207

MANAGEMENT REPRESENTATIVE AND QSP-4.01.205


MANAGEMENT REVIEW

ORGANIZATION QSP-4.01.206

QUALITY POLICY QSP-4.01.202

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4.2 Quality System


1. Policy
Brown Manufacturing Company, Inc. maintains a formal quality system to ensure
that products conform to specified requirements. The quality system is designed to
meet standards of the International Organization for Standardization, ISO
9002(1994).(4.2.1)
2. Key System Components
4.2.2.1. The quality system is documented and maintained. It consists of four levels
as follows:(4.2.1)
Level 1 Quality Policy Manual
Level 2 Quality Procedures
Level 3 Additional Supporting Instructions
Level 4 Forms, Labels, Records etc.

4.2.2.2. Quality planning activities define and document how quality requirements
will be met.(4.2.3)

4.2.2.3. The quality system effectively utilizes a multi-disciplinary team approach to


plan and achieve quality goals.(4.2.3.1)

4.2.2.4. Advanced quality planning is consistent with the Advanced Product Quality
Planning and Control Plan Reference Manual and is in effect to assure the
effective quality performance of new products.(4.2.3, 4.2.3a-h) Advanced
quality planning is used when required by contract.

4.2.2.4.1. The application of FMEA called for by the APQP manual is utilized by
applying customer recommended methodology as required by contract.

4.2.2.4.2. Special characteristics are finalized with appropriate controls being


established as required by contract.

4.2.2.4.3. Feasibility reviews are conducted which assess the suitability of process
for production and are documented as required by the APQP manual
and as required by contract.

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Key System Components (Continued)

4.2.2.4.4. Process FMEA considers all special characteristics with efforts directed
at process improvement to achieve defect prevention and the reduction
of high risk priority numbers as required by contract.

4.2.2.4.5. Control plans, utilizing multi-disciplinary teams, are developed at the


system, subsystem, component and/or material level as appropriate.
Plans cover pre-launch and production as appropriate to meet customer
requirements as required by contract.

4.2.2.4.6. Customer requirements for review and approval of FMEAs and control
plans are met as required by contract.

4.2.2.4.7. Control plans are reviewed and updated as appropriate when product or
process changes occur and when processes become unstable or non
capable as required by contract.

4.2.2.5. The production process is analyzed and qualified according to the practices
defined in the Production Part Approval Process which is utilized in full
where specified by the customer.

4.2.2.6. All appropriate documentation and evidence is prepared and retained.


Sample parts may be retained as evidence when not forwarded to the
customer and when required by customer contract.

4.2.2.7. Appropriate evidence is provided to the customer in accordance with the


customer-agreed submission level.

4.2.2.8. Additional customer procedures for part approval are observed where
specified.

4.2.2.9. Sub-contractors are required to comply with the Production Part Approval
Process requirements, as specified by Brown Manufacturing Company, Inc.
purchase agreements when required by contract.

4.2.2.10. Part approval is requested when processes are changed (when required by
customer guidelines).

4.2.2.11. Each activity within the company, including all business and support
services, pursues continuous improvement in all aspects of performance,
with emphasis on customer-perceived quality, cost, and delivery factors.

4.2.2.12. Executive and operating management monitors selected objective


indicators of performance and use action plans to improve

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Key System Components (Continued)

customer-important processes demonstrating stability, predictability, and


capability.

4.2.2.13. The highest priority for continuous improvement is given to special


characteristics.

4.2.2.14. Long-term performance history is periodically evaluated and trends are


analyzed.

4.2.2.15. Targets are established based on performance. Priority is given to indicators


that do not attain satisfactory customer performance levels.

4.2.2.16. Performance indicators are updated as appropriate.

4.2.2.17. Opportunities for quality and productivity improvements are identified and
improvement projects are implemented as appropriate.

4.2.2.18. Effective implementation of the Quality System is supported and monitored


by management.(4.2.2)

4.2.2.19. Authorities for the Quality System are identified in procedures.

3. Responsibility
MGMT REVIEW Management Review Team
4. References
Advanced Product Quality Planning and Control Plan, APQP
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
Potential Failure Mode and Effects Analysis Reference Manual, FMEA
Production Part Approval Process, PPAP
5. Related Procedures
ADVANCED QUALITY PLANNING QSP-4.02.201

PART APPROVAL PROCESS QSP-4.02.202

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4.3 Contract Review


1. Policy
Performance indicators are updated as appropriate to ensure requirements
received from the customer are fully understood and current capability exists to
meet all aspects of the customer requirements prior to acceptance of the contract.
2. Key System Components
4.3.2.1. Contracts are reviewed prior to acceptance through a documented process.
Records of contract reviews are kept.(4.3.1, 4.3.2, 4.3.4)

4.3.2.2. The review ensures:

4.3.2.2.1. requirements are adequately defined and documented.

4.3.2.2.2. requirements differing from the quote are resolved.(4.3.2)

4.3.2.2.3. capability can meet contract requirements.(4.3.2)

4.3.2.2.4. customer-specific requirements are identified and conformance


verified.(4.3.2)

4.3.2.2.5. the requirements for orders received by verbal means are agreed to
before their acceptance.

4.3.2.3. Contract amendments are reviewed and approved through a similar


process.(4.3.3)

4.3.2.4. Upon acceptance of contract amendments, all affected functions are


advised of the impact.

4.3.2.5. Procedures are in place to effectively maintain and guarantee confidentiality


of products as required by contract.

4.3.2.6. Authorities for Contract Review are identified in procedures.

3. Responsibility
OFF MGR Office Manager

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4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
CONTRACT REVIEW QSP-4.03.201

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4.4 Design Control


1. Policy
Brown Manufacturing Company, Inc. does not perform its own design functions.

Thus, this section and its requirements are not applicable at this time.

2. Key System Components

3. Responsibility

4. References

5. Related Procedures

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4.5 Document and Data Control


1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures to control
documents and data that affect and are related to the product. Control extends from
the initial receipt through review, approval, issuance, and obsolescence.(4.5.1)
2. Key System Components
4.5.2.1. Up-to-date documentation required for the effective function of the quality
system is available at all appropriate locations. Where such documentation
is held on electronic media it is subject to back up procedures and storage
control.(4.5.2)

4.5.2.2. Up-to-date copies of referenced customer drawings, specifications and


standards are available at the point of use. Changes to these copies are
subject to a recording system.(4.5.2)

4.5.2.3. Special characteristics affecting quality or regulatory compliance are


identified with customer specified symbols as required.

4.5.2.4. Documents and data are reviewed by authorized personnel for adequacy
and approved for release by a designated final approval authority.
Documents will be reviewed per documented procedures.(4.5.2)

4.5.2.5. Changes to documentation are carried out by the original final approval
authority, unless otherwise designated.(4.5.3, 4.5.2)

4.5.2.5.1. Pertinent background information is available for review.(4.5.2.a, 4.5.3)

4.5.2.5.2. The nature of a document change is identified when practicable.(4.5.3)

4.5.2.6. A master list is maintained to identify the current revisions of all controlled
and approved documentation.(4.5.2)

4.5.2.7. Invalid and/or obsolete documents are promptly removed from all points of
issuance, use or are otherwise prevented from unintended use. Those
retained for legal or knowledge purposes are suitably identified.(4.5.2.b, c)

4.5.2.8. Authorities for Document and Data Control are identified in procedures.

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3. Responsibility
OFF MGR Office Manager
QUAL CONTR Quality Control Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
DOCUMENT CONTROL - EXTERNAL DOCUMENTS QSP-4.05.202

DOCUMENT CONTROL - INTERNAL DOCUMENTS QSP-4.05.201

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4.6 Purchasing
1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures to ensure
products and services obtained from outside suppliers conform to specified
requirements.(4.6.1, 4.6.2.b)
2. Key System Components
4.6.2.1. Brown Manufacturing Company, Inc. has an approved subcontractor list and
purchases relevant materials only from subcontractors on that list.(4.6.1)

4.6.2.2. Subcontractors are selected after an evaluation based on their ability to


meet requirements. Subcontractor controls depend upon the type of
product, impact on final product quality and previous history of supply.
Records of product supply are maintained. Customer subcontractors lists
are utilized when applicable and new subcontractors only used after they
are added to such lists.(4.6.2.a-c)

4.6.2.3. Subcontractors who are certified to ISO-9000 requirements by third parties


are exempt from the subcontractor evaluation process.

4.6.2.4. Sub-contractor delivery performance is monitored per documented


procedures. Performance delivery reports and records of product supplied
are reviewed at intervals and used to control the approved sub-contractor
list.(4.6.2.c)

4.6.2.5. Purchasing documents clearly describe the products ordered. Planning


systems are utilized to ensure the timely receipt of products.(4.6.3)

4.6.2.6. Purchasing documents are reviewed and approved prior to use.(4.6.3)

4.6.2.7. Critical purchased materials are verified as to specification


requirements.(4.6.4.1)

4.6.2.8. Methods for release and verification of purchased product at subcontractor


premises is specified in purchasing documents. Customer representatives
may verify conformance to requirements as agreed. Customer verification is
not used as evidence of effective subcontractor quality control nor shall it
serve as acceptance by the customer.(4.6.4.2)

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Key System Components (Continued)

4.6.2.9. Authorities for Purchasing are identified in procedures.

3. Responsibility
PURC MGR Purchasing Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
PURCHASING QSP-4.06.201

SUPPLIER PERFORMANCE QSP-4.06.203

SUPPLIER SELECTION QSP-4.06.202

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4.7 Control of Customer Supplied Product


1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures to control
products furnished by customers and to ensure they are verified, stored and
maintained.(4.7)
2. Key System Components
4.7.2.1. Suitability of customer-supplied product, customer-owned tooling and
returnable packaging is verified.

4.7.2.2. Unsuitable, lost, or damaged products are recorded and immediately


reported to the customer.(4.7)

4.7.2.3. Documented procedures are maintained to incorporate customer materials


into appropriate inventory control systems, ensuring adequate storage and
maintenance.(4.7)

4.7.2.4. Authorities for Control of Customer Supplied Product are identified in


procedures.

3. Responsibility
MATL MGR Materials Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
CUSTOMER CONSIGNED MATERIAL CONTROL QSP-4.07.201

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4.8 Product Identification and Traceability


1. Policy
Brown Manufacturing Company, Inc. ensures products maintain identification and
traceability during all stages of production and delivery as required by customer
contract.
2. Key System Components
4.8.2.1. Documented procedures are maintained for the identification of the product
through all stages of receipt, production, and delivery.(4.8)

4.8.2.2. Where required by contract, documented traceability procedures are


maintained using unique identification for individual product or batches. This
identification is recorded.(4.8)

4.8.2.3. Sub-contractors are required to identify individual product or batches where


traceability is required by customer contract.

4.8.2.4. Authorities for Product Identification and Traceability are identified in


procedures..

3. Responsibility
PROD MGR Production Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
PRODUCT IDENTIFICATION, TRACEABILITY AND QSP-4.08.201
STATUS

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4.9 Process Control


1. Policy
Brown Manufacturing Company, Inc. ensures that production processes are
planned, analyzed, and qualified to ensure quality performance. Processes are
carried out under controlled conditions.
2. Key System Components
4.9.2.1. Production processes affecting quality are identified and planned under the
control of documented procedures.(4.9, 4.9.a)

4.9.2.2. Customer production process approval is obtained in accordance with the


Production Part Approval Process Reference Manual as required by
contract. Records of such approvals are maintained.

4.9.2.3. Process changes are controlled in accordance with customer requirements


as specified in Production Part Approval Process Reference Manual as
required by contract. Records are maintained.

4.9.2.4. Initial process studies, utilizing the Advanced Quality Planning procedure,
are conducted on special characteristics for new processes and significantly
changed products and processes as required by contract.

4.9.2.5. Processes are carried out under the following controlled conditions:

4.9.2.5.1. documented procedures exist for implementing and maintaining APQP


approved process capability and performance using methods
conforming to customer requirements for production as required by
contract(4.9.g)

4.9.2.5.2. the use of suitable production equipment compliant with applicable


government safety and environmental regulations(4.9.b)

4.9.2.5.3. a suitable working environment(4.9.b)

4.9.2.5.4. premises maintained in a manner applicable to the product with


appropriate indicators of cleanliness(4.9.b)

4.9.2.5.5. compliance with references, standards/codes, and control plans(4.9.c)

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Key System Components (Continued)

4.9.2.5.6. monitoring and control of processes and product characteristics by


qualified operators to meet specifically defined requirements. Records
of special processes are maintained.(4.9, 4.9.d, 4.9.g)

4.9.2.5.7. designation, control, and documentation of special characteristics(4.9.d)

4.9.2.5.8. the approval of special processes, equipment, and personnel as


appropriate and the maintenance of relevant records.(4.9.e, 4.9.g)

4.9.2.5.9. criteria for workmanship, including representative samples where


applicable(4.9.f)

4.9.2.5.10. suitable maintenance of equipment to ensure continuing process


capability(4.9.g)

4.9.2.6. An effective Preventive and Predictive Maintenance system is defined in a


documented procedure.(4.9.g)

4.9.2.7. Documented instructions derived from appropriate sources are accessible


at operator workstations for process monitoring and operations.

4.9.2.8. Job setups are verified as producing parts that meet all requirements.

4.9.2.9. Process control will incorporate safety and due care considerations. Internal
awareness of safety considerations will be promoted.

4.9.2.10. Authorities for Process Control are identified in procedures.

3. Responsibility
PROD MGR Production Manager
4. References
Advanced Product Quality Planning and Control Plan, APQP
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
Production Part Approval Process, PPAP
5. Related Procedures
PROCESS SETUP QSP-4.09.203

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Related Procedures (Continued)

PRODUCTION EQUIPMENT MAINTENANCE QSP-4.09.204

PRODUCTION PROCESS QSP-4.09.202

PRODUCTION PROCESS DEVELOPMENT AND QSP-4.09.201


QUALIFICATION

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4.10 Inspection and Testing


1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures for
inspection and testing to verify that specified requirements for products are
met.(4.10.1, 4.10.4)
2. Key System Components
4.10.2.1. Attribute sampling plans utilize a zero-defect acceptance criterion.(4.10.1)

4.10.2.2. Acceptance standards are documented.(4.10.1)

4.10.2.3. Customer-approved sources are utilized, where specified.

4.10.2.4. Verification of incoming materials is planned and documented to assure


conformance to specifications.(4.10.2.1, 4.10.2.2)

4.10.2.5. Material is not released prior to verification unless positive recall is


provided.(4.10.2.3, 4.10.3.b)

4.10.2.6. Process monitoring is utilized when practical rather than defect detection.

4.10.2.7. Nonconforming products are identified and handled as specified.(4.10.5)

4.10.2.8. No product is dispatched until all inspections and tests are carried out in
conformance with the control plan. Records of these inspections or tests will
clearly show the status of the product.(4.10.2.1, 4.10.3.a, 4.10.3.b, 4.10.4,
4.10.5)

4.10.2.9. Customer requirements for laboratory accreditation are met where specified.

4.10.2.10. Regulatory and safety constraints on materials are observed.

4.10.2.11. Records are maintained on all inspections and tests.(4.10.4)

4.10.2.12. Authorities for Inspection and Testing are identified in procedures.(4.10.4,


4.10.5)

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3. Responsibility
QUAL ASSUR Quality Assurance Manager
QUAL CONTR Quality Control Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
INSPECTION AND TESTING QSP-4.10.201

LABORATORY TESTING QSP-4.10.202

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4.11 Control of Inspection, Measuring and Test Equipment


1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures to ensure
that inspection, measuring, and test equipment is controlled, calibrated, handled,
stored and maintained. This equipment is consistent with the required
measurement capability.(4.11.1)
2. Key System Components
4.11.2.1. The scope of this policy includes all inspection, measurement, test
equipment, and software used to demonstrate the conformance of product
to the specified requirements.

4.11.2.2. Inspection, measuring, and testing equipment is identified, calibrated and


adjusted at prescribed intervals or prior to use against certified equipment
traceable to ISO/IEC Guide 25, the National Institute of Standards and
Technology, or other nationally recognized standards. This includes tooling
department equipment used to maintain production tools. When no
standards exist, the basis for calibration is documented.(4.11.1, 4.11.2.b)

4.11.2.3. Documented calibration and/or verification procedures are maintained and


used.(4.11.1, 4.11.2.b, 4.11.2.c)

4.11.2.4. Inspection, measuring, and test equipment have the necessary accuracy
and precision.

4.11.2.5. Measurement system capability is assessed per the procedures defined in


Measurement System Analysis when required by contract. When they are
required, these analytical methods will apply to measurement systems
referenced in the Control Plan.(4.11.2.a, 4.11.2.c)

4.11.2.6. Equipment is identified with suitable indicators or records to show


status.(4.11.2.d)

4.11.2.7. Calibration records are maintained which comply with customer specified
requirements, if any.(4.11.1, 4.11.2.e)

4.11.2.8. If equipment is found to be out of calibration, validity of prior inspections is


assessed.(4.11.2.f)

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Key System Components (Continued)

4.11.2.9. Environmental conditions are suitable for the tests or calibrations being
performed.(4.11.2.g)

4.11.2.10. Handling, preservation and storage practices ensure that accuracy is


maintained.(4.11.2.h)

4.11.2.11. If contractually required, measurement system design data is made


available to our customers or their representatives for verification of
functional adequacy.(4.11.1)

4.11.2.12. Whenever physically possible, equipment is safeguarded against


adjustments which would invalidate calibrations settings.(4.11.2)

4.11.2.13. A master list of all gages, measuring and test equipment is maintained.

4.11.2.14. Authorities for Control of Inspection, Measuring, and Test Equipment are
identified in procedures.

3. Responsibility
QUAL ASSUR Quality Assurance Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
Measurement Systems Analysis Reference Manual, MSA
5. Related Procedures
INSPECTION EQUIPMENT CONTROL, MAINTENANCE QSP-4.11.202
AND CALIBRATION

MEASUREMENT SYSTEMS DEVELOPMENT AND QSP-4.11.201


QUALIFICATION

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4.12 Inspection and Test Status


1. Policy
Brown Manufacturing Company, Inc. ensures products maintain the identification of
inspection and test status of conformance or nonconformance.(4.12)
2. Key System Components
4.12.2.1. All products maintain positive identification of conformance or
nonconformance status.(4.12)

4.12.2.2. Identification procedures ensure that only conforming products are


dispatched, used or installed, except when released under authorized
concession.(4.12)

4.12.2.3. Customer requirements for supplemental identification are observed.(4.12)

4.12.2.4. Authorities for Inspection and Test Status are identified in procedures.

3. Responsibility
QUAL ASSUR Quality Assurance Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
INSPECTION AND TEST STATUS QSP-4.12.201

PRODUCT IDENTIFICATION, TRACEABILITY AND QSP-4.08.201


STATUS

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4.13 Control of Nonconforming Product


1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures to ensure
that product that does not conform to specified requirements is prevented from
unintended use. Control provides for identification, documentation, evaluation,
segregation (when practicable), disposition and notification of areas affected. Active
programs to reduce scrap and rework are in effect.(4.13.1, 4.13.2)
2. Key System Components
4.13.2.1. Nonconforming and suspect product is reviewed in accordance with
documented procedures.(4.13.1, 4.13.2)

4.13.2.2. Where applicable nonconforming product is reworked, according to


documented rework instructions to ensure conformance with the specified
requirements of the PPAP submission (when contractually required) and
customer requirements.

4.13.2.3. Customer engineering approved product authorization is obtained for


nonconforming product that cannot be reworked to comply with the specified
requirements but can be repaired according to documented repair
instructions in order to fulfill intended usage or will still be acceptable to the
customer without rework or repair. Procedures ensure compliance with
specifications on expiry of authorization. This process is also applicable to
processes that differ from those currently approved and products or
processes purchased from subcontractors.(4.13.2)

4.13.2.4. Reworked and repaired product is re-inspected in accordance with the


quality plan.(4.13.2)

4.13.2.5. Product that cannot be reworked or repaired and is unacceptable to the


customer is regraded for alternative applications, rejected or scrapped.

4.13.2.6. Authorities for Control of Nonconforming Product are identified in


procedures.

3. Responsibility
PROD MGR Production Manager

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4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
NONCONFORMING MATERIAL CONTROL QSP-4.13.201

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4.14 Corrective and Preventive Action


1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures for
controlling corrective and preventive action.(4.14.1)
2. Key System Components
4.14.2.1. Corrective action procedures include:

4.14.2.1.1. effective handling of customer complaints and reports of


nonconformance.(4.14.2.a)

4.14.2.1.2. investigating the causes of nonconformance and the action needed to


prevent recurrence using disciplined problem solving and/or mistake
proofing methods.(4.14.1, 4.14.2.a, 4.14.2.b, 4.14.2.c)

4.14.2.1.3. investigating the causes of nonconformance and the action needed to


prevent recurrence using disciplined methods.(4.14.2.a)

4.14.2.1.4. the analysis of processes, work operations, concessions, quality


records, customer complaints, and returned product to detect and
eliminate potential causes of the nonconforming product.(4.14.1)

4.14.2.1.5. preventive actions at a level corresponding to the risk


encountered.(4.14.2.a, 4.14.2.d)

4.14.2.1.6. verification that corrective actions are taken and are effective.(4.14.1,
4.14.2)

4.14.2.1.7. implementing and recording changes in procedures resulting from


corrective actions.

4.14.2.2. Preventive action includes:

4.14.2.2.1. maintaining and utilizing information on performance to detect, analyze


and eliminate potential causes of nonconformance.(4.14.2, 4.14.3.b)

4.14.2.2.2. planning the steps needed to improve; obtaining management review


and approval; obtaining customer approval where needed;
implementing the plan and verifying the effectiveness.(4.14.3.a, 4.14.3.c)

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Key System Components (Continued)

4.14.2.3. Disciplined problem methods are used for internal and external
nonconformance. Customer defined methods are utilized when responding
to external nonconformance as contractually specified.(4.14.1)

4.14.2.4. Records of corrective and preventive action activities are kept. All relative
information on Corrective and Preventive Actions taken are submitted for
Management Review.(4.14.1, 4.14.3.d)

4.14.2.5. Authorities for Corrective and Preventive Action are identified in procedures.

3. Responsibility
PROD MGR Production Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
CORRECTIVE ACTION AND PROBLEM SOLVING QSP-4.14.201

CUSTOMER CONCERNS QSP-4.14.202

PREVENTIVE ACTION QSP-4.14.203

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4.15 Handling, Storage, Packaging, Preservation and Delivery


1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures to ensure
that products are controlled through handling, storage, packaging, preservation and
delivery in such a manner that product integrity is maintained.(4.15.1)
2. Key System Components
4.15.2.1. Handling methods are provided to prevent damage and deterioration.(4.15.2)

4.15.2.2. Designated storage areas are maintained that utilizes appropriate methods
for preservation, segregation, receipt and dispatch.(4.15.3, 4.15.5)

4.15.2.3. An inventory management system is established that assures periodic


assessment of product condition.(4.15.3)

4.15.2.4. Packaging, preservation and labeling processes are monitored and


controlled, in accordance with customer requirements and documented
procedures.(4.9.g, 4.15.4, 4.15.6)

4.15.2.5. Products are protected through delivery to the customer, in accordance with
customer requirements.(4.15.6)

4.15.2.6. Shipments are made in accordance with customer transportation


specifications.(4.15.6)

4.15.2.7. Shipment and production schedules are developed to meet customer


requirements.

4.15.2.8. Systems are in place to support 100% on-time shipments to meet customer
production and service requirements.(4.15.6)

4.15.2.9. Continuous efforts to improve inventory utilization are planned and executed
wherever possible.

4.15.2.10. Customer requirements for communication regarding shipments are


observed as required by contract.(4.15.6)

4.15.2.11. Authorities for Handling, Storage, Packaging, Preservation, and Delivery are
identified in procedures.

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3. Responsibility
MATL MGR Materials Manager
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
DELIVERY PERFORMANCE MONITORING QSP-4.15.204

PACKAGING QSP-4.15.201

SCHEDULING, INVENTORY MANAGEMENT AND QSP-4.15.203


SHIPPING

STORAGE AND INVENTORY CONTROL QSP-4.15.202

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4.16 Control of Quality Records


1. Policy
Brown Manufacturing Company, Inc. maintains quality records to demonstrate
conformance to specified requirements.(4.16)
2. Key System Components
4.16.2.1. Quality records are:

4.16.2.1.1. identified, collected, indexed, accessed, filed, stored and maintained


according to documented procedures.(4.16)

4.16.2.1.2. readily retrievable.(4.16)

4.16.2.1.3. maintained in a suitable environment to prevent damage or deterioration


and prevent loss.(4.16)

4.16.2.1.4. legible and identifiable to the product involved.(4.16)

4.16.2.1.5. retained as required by customers and/or regulatory agencies.(4.16)

4.16.2.2. Quality records include internal quality audit and management review
records which are retained for a minimum of three years. PPAP records,
tooling records, purchase orders and amendments are kept for the duration
of active production, plus a minimum of one calendar year.(4.16)

4.16.2.3. Sub-contractor quality records are an element of quality records. When


required by contract, customer access to records is facilitated.(4.16)

4.16.2.4. Copies of documents from superseded parts required for new part
qualification are retained.

4.16.2.5. Authorities for Control of Quality Records are identified in procedures.

3. Responsibility
QUAL CONTR Quality Control Manager

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4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
QUALITY RECORD MAINTENANCE QSP-4.16.201

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4.17 Internal Quality Audits


1. Policy
Brown Manufacturing Company, Inc. plans and implements internal quality audits to
verify and assess the operation and effectiveness of the quality system and have
objective evidence to demonstrate capability to meet all ISO 9002 requirements.
2. Key System Components
4.17.2.1. Audits are scheduled on the basis of the status and importance of the
activity to be audited.(4.17)

4.17.2.2. Audits and follow-up actions are conducted according to documented


procedures.(4.17)

4.17.2.3. Audits are conducted by personnel independent of the areas being


audited.(4.17)

4.17.2.4. Audit scope includes suitability of environmental conditions.

4.17.2.5. All remote locations that support this site (if any) are to be included in the
initial audit and participate in a surveillance audit at least once in every
twelve months.(4.17)

4.17.2.6. Results of the audits are recorded and communicated to management


responsible for the area being audited.(4.17)

4.17.2.7. Timely corrective action is taken, recorded and verified based on the results
of the audit.

4.17.2.8. Authorities for Internal Quality Audits are identified in procedures.

3. Responsibility
MGMT REP Management Representative
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO

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5. Related Procedures
INTERNAL AUDITS QSP-4.17.201

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4.18 Training
1. Policy
Brown Manufacturing Company, Inc. maintains documented procedures to ensure
that training needs are identified and training provided to all personnel performing
activities affecting quality.(4.18)
2. Key System Components
4.18.2.1. Personnel are qualified based on appropriate education, training, and/or
experience.(4.18)

4.18.2.2. Records of training are maintained.(4.18)

4.18.2.3. A periodic review of training needs and training effectiveness is conducted


for each position.

4.18.2.4. Education and training is viewed as a strategic issue and in order to achieve
the required level of performance is conducted according to a documented
training plan.

4.18.2.5. Authorities for Training are identified in procedures.

3. Responsibility
EXEC VP Executive Vice President
4. References
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
5. Related Procedures
BASIC TRAINING PROGRAM QSP-4.18.203

TRAINING NEEDS ASSESSMENT AND EVALUATION QSP-4.18.201

TRAINING RECORD MAINTENANCE QSP-4.18.202

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4.19 Servicing
1. Policy
Brown Manufacturing Company, Inc. does not have any services required by
contract.

Thus, this section and its requirements are not applicable at this time.

2. Key System Components

3. Responsibility

4. References

5. Related Procedures

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4.20 Statistical Techniques


1. Policy
Brown Manufacturing Company, Inc. identifies and uses statistical techniques
required to provide information for establishing, controlling and verifying process
capability and product characteristics.(4.20.1)
2. Key System Components
4.20.2.1. Process capability is determined as provided for in Advanced Product
Quality Planning.

4.20.2.2. Statistical process control techniques are used to verify capability and
ongoing process performance as required by contract.

4.20.2.3. Statistical problem solving techniques are utilized to support production,


preventive and corrective actions as appropriate.

4.20.2.4. Documented procedures are maintained for the selection, implementation,


and control of statistical techniques when required by contract.(4.20.2)

4.20.2.5. A basic understanding of SPC concepts is a training requirement for


appropriate personnel.

4.20.2.6. Authorities for Statistical Techniques are identified in procedures.

3. Responsibility
QUAL CONTR Quality Control Manager
4. References
Advanced Product Quality Planning and Control Plan, APQP
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
Statistical Process Control, SPC, Reference Manual
5. Related Procedures
STATISTICAL METHODS QSP-4.20.201

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Glossary
Term Definition Sector
Accelerated Life Testing Verification of machine and equipment design
relationship much sooner than if operated
typically. Intended especially for new technology,
design changes and ongoing development.
Accredited Registrars Accredited Registrars are qualified organizations
certified by a national body (e.g. the Registrar
Accreditation Board in the U.S.) to perform audits
to the QS-9000 and to register the audited facility
as meeting these requirements for a given
commodity.
Accuracy A measure of the difference (bias) between the
average of the readings from a measurement
system and a corresponding benchmark or
master.
Action Plan Plan for improving a quality issue related to a
process or product.
Active Part A part currently supplied to a customer for original
equipment or service applications. The part
remains active until tooling scrap authorization is
given by the appropriate customer activity.
Appraisal Costs The costs of assessing the quality achieved.
Approved Material Materials governed either by industry standard
specifications (e.g., SAE, ASTM, DIN, ISO) or by
customer specifications. For customer
specifications, materials may be purchased only
from customer approved sources.
Approved Source List A list of suppliers and sub-suppliers that have
been found to be acceptable to the customer.
Assessment An evaluation process including a document
review, an on-site audit and an analysis and
report. Customers may also include a
self-assessment, internal audit results and other
materials in the assessment.
Audit An on-site verification activity based upon a
sample used to determine the effective
implementation of a supplier's documented
quality system.

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Glossary (Continued)

Availability A measure of the degree to which tooling and


equipment is in an operable and committable
state at any point in time. Specifically, the percent
of time that tooling and equipment will be
operable when needed.
Benchmark Data The results of an investigation to determine how
competitors and/or best-in-class companies
achieve their level of performance.
Calibration Adjustments to measuring devices so that they
measure accurately.
Capability The total range of inherent variation in a stable
process. It is determined using data from control
charts.
Certification Procedure by which a third party gives written
assurance that a product, process or service
conforms to specific requirements.
Certified Registrars Qualified organizations certified by a national
body (e.g., the Registrar Accreditation Board in
the U.S.) to perform audits of the Quality System
Requirements and to register the audited facility
as meeting these requirements for a given
commodity.
Characteristic Distinguishing feature of a process or product.
Concern Any statement of known or potential
nonconformance or dissatisfaction by any
customer representative.
Conditioning Storing a product (or sample) in a known
environment for stabilizing the sample content.
Consulting The provision of training, documentation
development, or assistance with implementation
of quality systems to a specific customer.
Containment Action Short-term actions put in place to address a
quality issue until permanent corrective actions
are determined and implemented.
Control Plans Written descriptions of the systems for controlling
parts and processes that address important
characteristics and engineering requirements.
Each part must have a control plan that may also
apply to a family or parts produced with a
common process.

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Glossary (Continued)

Corrective Action Action taken to eliminate the causes of an


existing nonconformity, defect or other
undesirable situation in order to prevent
recurrence.
Corrective Action Plan Document specifying actions to be implemented
for correcting a process or part quality issue, with
responsibilities and target dates assigned.
Corrective Action A detailed report issued in response to a
Request (CAR) Nonconformance Report (NCR), specifying those
actions to be taken at both the immediate and the
system levels to correct the stated
noncompliances.
Customer-supplied A material, part, tool, or assembly provided by a
Product customer used to complete a product contracted
by the customer. The customer retains ownership
of all such materials.
Design Failure Mode A systematized group of activities intended to: 1)
and Effects Analysis recognize and evaluate the potential failure of a
(DFMEA) product and its effects, 2) identify actions which
could eliminate or reduce the chance of the
potential failure occurring, and 3) document the
process.
Design for A simultaneous engineering process designed to
Manufacturing and optimize the relationship between design function,
Assembly manufacturability and ease of assembly.
Design Validation Testing to ensure that the product conforms to
defined user needs and/or requirements. Design
validation follows successful design verification
and is normally performed on the final product
under defined operating conditions. Multiple
validations may be performed if there are different
intended uses.
Design Verification Review of all design features to ensure that all
design requirements have been met, through
independent inspection, alternative calculations,
or other methods.
Design Verification Plan A document which details a design verification
and Report (DVPR) plan and reports status of the verification. It lists
the evaluation and tests required for a program
and also reports the assessment and test results

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for each evaluation performed.


Destruction Items that may be destroyed during or after
testing, rendering them unfit for further use.
Document Any paper or computer data file that contains
technical information defining a process to be
followed. Examples include drawings,
specifications, manufacturing instructions,
inspection instructions, and sample parts.
Documentation Material (typically paper or electronic) defining the
process to be followed (e.g. quality manual,
operator instructions, graphics, pictorials).
Dry Run The rehearsal or cycling of machinery, normally
with the intent of NOT processing the work piece,
to verify: function, clearances and construction
stability.
Durability Ability to perform intended function over a
specified period under normal use with specified
maintenance, without significant deterioration.
Economics of Quality A method of collecting quality related costs in
order to assess the overall effectiveness of the
management of quality and determine problem
areas and action priorities.
Engineering Approved Written customer authorization that is required
Product Authorization whenever the product or process varies from
(EAPA) those currently approved. (see the Chrysler, Ford,
General Motors Production Part Approval
Process manual).
Environment All the conditions surrounding and affecting
manufacture and quality of a part or product.
Equipment The portion of process machinery which is not
specific to a component or sub-assembly.
External Failure Costs The costs, arising outside of the organization, of
the failure to achieve the quality specified after
transfer of ownership to the customer.
Failure Mode and Effect A systematized group of activities intended to: 1)
Analysis (FMEA) recognize and evaluate the potential failure of a
(product/process) and its effects, 2) identify
actions which could eliminate or reduce the
chance of the potential failure occurring, and 3)
document the process.

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Fault Tree Analysis A top-down approach to failure analysis starting


(FTA) with an undesirable event and determining all the
ways it can happen.
Feasibility A determination that a process, design, procedure
or plan can be successfully accomplished in the
required time frame.
Functional Verification Testing to ensure the part conforms to all
customer and supplier engineering performance
and material requirements.
Gage Repeatability and A measurement device's ability to report the
Reproducibility (GR & R) same results when the same operator measures
the same part more than once (repeatability) and
the variation when different operators measure
the same part with the same measurement
device (reproducibility).
Gage Reproducibility The variation which occurs when different
operators measure a part using the same gage
(between-operator variability).
Gantt Chart A simple tool that uses horizontal bars to show
which tasks can be done simultaneously over the
life of the project.
Inspection, Measuring All devices used to inspect, examine, test or gage
and Test Equipment conformance of a product or process with regard
to one or more characteristics or attributes.
Internal Audit Verifies that quality activities comply with
contractual obligations and determines the
effectiveness of the quality system.
Internal Failure Costs The costs arising within the organization of the
failure to achieve the quality specified before
transfer of ownership to the customer.
Job Instructions Describes work conducted in one function in a
company (e.g. set-up, inspection, rework,
operator) and considered to be level three (3)
quality system documentation.
Job Number Format A Brown Manufacturing Company job number
consists of three elements divided by hyphens.
The first element is the letter "J". The second
element is a four-digit job number. The third
element is a three-digit "suffix" or "dash number".
"Job Number" refers only to the first two

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elements. "Job Number and Suffix" or "Job


Number and Dash Number" refers to all three
elements. "Work Order Number" refers only to
the second element.
Known Environment At atmosphere of a known condition that is
monitored and recorded, also allowing (where
applicable) extrapolation of calculation for
measurement error.
Last Off Part Comparison A comparison of the last part made in a
production run with a part from the next
production run to verify that the quality level of the
new part is at least as acceptable as that of the
previous run.
Layout Inspection The complete measurement of all part
dimensions shown on the design record.
Life Cycle The sequence through which machinery and
equipment passes from conception through
decommission.
Life Cycle Cost (LCC) The sum of all cost factors incurred during the
expected life cycle of the machinery.
Machinery Tooling and Equipment combined. A generic term
for all hardware (including necessary operational
software) which performs a manufacturing
process.
Maintainability A characteristic of design, installation and
operation, usually expressed as the probability
that a machine can be retained in, or restored to,
specified operable condition within a specified
interval of time when maintenance is performed in
accordance with prescribed procedures.
Major Suppliers Suppliers designated by management as having
significant potential impact on quality.
Management Review A periodic formal evaluation of the effectiveness
of the quality system in achieving the quality plan
and objectives.
Mean Time Between The average time between failure occurrences.
Failures (MTBF) The sum of the operating time of a machine
divided by the total number of failures.
Mean Time To Repair The average time to restore machinery or
(MTTR) equipment to specified conditions.

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Nonconformance Product or material which does not conform to


customer requirements or other specifications.
Nonconformance Report An organized report specifying the nature of a
(NCR) noncompliance with one or more specific ISO
standard(s) and clause(s). It may be
characterized as "major" or "minor." NCR's
require a Corrective Action Request and
Corrective Action Plan.
Nonconforming Product Product which does not conform to customer
requirements or other specifications.
Nonconformity A process which does not conform to a quality
system requirement.
Ongoing Process A long-term measure of statistical process
Capability control, or process performance. Reference
Fundamental SPC Reference Manual.
Operator Instruction Describes production work performed in one
function or work center.
Part Number Format A Brown Manufacturing Company Part Number
consists of three elements. The first element is
the customer part number. The second element
consists of the letters "Rev" plus the revision level
plus a colon. The third element consists of the
part name.
Parts Per Million (PPM) A measure of process performance in terms of
actual or projected nonconforming material. In
general use, PPM defective is expressed as the
proportion nonconforming (defective parts/total
parts) times 1,000,000.
Perishable Tooling Tooling which is consumed over time, during a
manufacturing operation.
Predictive Maintenance A form of preventive maintenance that uses
historical data to predict failures and prevent
breakdowns through timely repair.
Preliminary Process See Preliminary Process Capability Studies.
Capability
Preliminary Process Short-term studies conducted to obtain early
Capability Studies information on the performance of new or revised
processes relative to internal or customer
requirements. Refer to Fundamental SPC
Reference Manual.

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Prevention Costs The costs of any action taken to investigate,


prevent, or reduce defects and failures.
Preventive Maintenance Planned activity of equipment maintenance based
on scheduled service and replacement of parts.
Problem Solving A disciplined methodology for addressing internal
Process (PSP) and external problems.
Procedures Documented processes that are used when work
affects more than one function or department of
an organization. Procedures are considered to be
level two (2) quality system documentation.
Process Any operation or sequence of operations which
contributes to the transformation of raw material
into a finished part or assembly.
Process Characteristics Measures of processing conditions affecting the
product characteristics of interest.
Process Failure Mode A systematized group of activities intended to: 1)
and Effects Analysis recognize and evaluate the potential failure of a
(PFMEA) process and its effects, 2) identify actions which
could eliminate or reduce the chance of the
potential failure occurring, and 3) document the
process.
Process Failure Modes An analytical technique which identifies potential
and Effects Analysis product-related process failure modes, assesses
(PFMEA) the potential customer effects of the failures,
identifies the potential manufacturing or assembly
process causes, and identifies significant process
variables to focus controls for prevention or
detection of failure conditions.
Product Product in relation to tooling and equipment
suppliers refers to the end item produced (e.g.,
machine, tool, die).
Product Characteristics Physical, visual, chemical or other direct
attributes of a product.
Production Production in relation to tooling and equipment
suppliers refers to the "process" required to
produce the product.
Production Run Number A number which identifies a unit of production,
made up of the Brown Manufacturing Company,
Inc. internal job number and an iteration identifier
("dash" number).

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QFD Quality Function Deployment


Quality Manual The supplier's document that describes the
elements of the quality system used to assure
customer requirements, needs and expectations
are met. The Quality Manual is considered to be
level one (1) Quality Systems Documentation.
Quality Planning A structured process for defining the methods
(i.e. as measurements, tests) that will be used in
the production of a specific product or family of
products (i.e. parts, materials). Reference
Advanced Product Quality Planning and Control
Plan Reference Manual.
Quality Procedure Written instructions to communicate the
established methods for performing and
managing work. Procedures are summaries
(Level II information). When needed, detailed
information is provided in work instructions (Level
III).
Quality Records Documented evidence that the supplier's
processes were executed according to the quality
system documentation (e.g. inspection and test
results, internal audit results, calibration data) and
records results.
Quality Related Costs Costs incurred in ensuring and assuring
satisfactory quality as well as the losses incurred
when satisfactory quality is not achieved.
Quality System Organizational structure, responsibilities,
procedures, processes and resources needed to
implement the quality policy.
Reaction Plan The action specified by a Control Plan when
non-conforming product or process instability is
identified.
Registered Suppliers/subcontractors who have received third
Suppliers/Subcontractors party QS-9000 certification for the commodity
supplied.
Registrar A company that conducts quality system
assessments to QS-9000 Requirements.
Release Date A target date for release of product for delivery as
specified by contract, as opposed to on-demand
releases with no contract-fixed date.

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Reliability The probability that an item will continue to


function at customer expectation levels at a
measurement point, under specified
environmental and duty cycle conditions.
Repair Action taken on nonconforming product so that
the product will fulfill the intended usage although
the product may not conform to the original
requirements.
Restricted Storage A location within the receiving area of the
laboratory where only authorized personnel have
access.
Retention Period A specific timetable for storage of specified
records.
Rework Action taken on nonconforming product so that it
will meet the specified requirements.
Reworked Product Products that did not meet all requirements as
originally produced but have been modified in the
manufacturing plant until all requirements are met.
Sample (or Product) An item manufactured, or supplied from
controlled processes requiring verification and/or
certification against customer or national
standards or specifications.
Sample Lot The production of a very limited quantity of parts
made to customer specifications for prototype or
research and development purposes. Sample lots
may not use production machinery and thus are
exempt from the Advanced Quality Planning
procedures of the Quality System except when
specifically required by customer contract.
Sample Stabilization Samples (or Product) retained within the
laboratory environment for climatizing, from an
unknown environment.
Service The provision of ongoing maintenance, repair or
refurbishment of product on the premises of a
customer where such work is the subject of a
contract separate to that for the original purchase
of the product.
Setup Verification Producing, measuring and testing a small sample
of parts for conformance to quality control
standards. If parts fall within the acceptable

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range, the setup is approved for production.


Shield Symbol used to identify a characteristic involving
regulatory or safety regulations.
Simultaneous Process by which all disciplines involved -
Engineering particularly Sales, Product Engineering,
Manufacturing Engineering, Materials
Management and Manufacturing - work together
to conceive, develop and implement new product
programs.
Special Characteristics A product or process element that is essential to
customer satisfaction and requires manufacturing
control.
Special Processes Production processes that cannot be
subsequently verified without destructive testing.
Statistical Process The use of statistical techniques such as control
Control charts to analyze a process or its output so as to
take appropriate actions, which achieve and
maintain a state of statistical control and improve
the capability of the process.
Statistical Technique A standard statistical method using samples of
characteristics to predict values for the entire lot.
Subcontractors Providers of materials, parts or services to a
supplier.
Supplier Company or individual which provides our
company with parts, materials or services. Major
suppliers are designated by management as
having significant potential impact on quality.
Suppliers Providers of materials, parts or services directly to
Chrysler, Ford and/or General Motors.
Suspect Product Individual products or product lots that may
include nonconforming material.
Tooling The portion of process machinery which is
specific to a component or sub-assembly.
Traceability Ability to trace the history, application, or location
of a product through identification at specified
intervals.
Training A structured process for communicating
knowledge and developing skills.

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Validation Confirmation by examination and provision of


objective evidence that the particular
requirements for a specific intended use are
fulfilled.
Value Engineering/Value A planned, clean-sheet approach to problem
Analysis solving that focuses on specific product design
and process characteristics. Where value
analysis is employed to improve value after
production has begun, value engineering is
employed to maximize value prior to expenditures
of facilities and tooling money.
Verification Confirmation by examination and provision of
objective evidence that specified requirements
have been fulfilled.
Visual Controls Techniques for conveying information by visual
means to observers so that everyone can easily
understand whether current conditions are
normal. Examples are floor markings, action
boards, standardized work charts and color
coding.

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Bibliography
ISO 9002 -- Quality systems -- Model for quality assurance in production,
installation and servicing, ISO
Advanced Product Quality Planning and Control Plan, APQP
Potential Failure Mode and Effects Analysis Reference Manual, FMEA
Production Part Approval Process, PPAP
Measurement Systems Analysis Reference Manual, MSA
Statistical Process Control, SPC, Reference Manual

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