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DOCUMENT
FOR REFENCE ONLY
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Products Group
Document Title: Quality Manual Corporate, Quality Document No.
Management C-4.2.2-000
Systems
PPR: Alan Leukhardt, V.P. Engineering and Effective Date: Revision No.: 5
Quality 3/5/2010
Review Date: Page No.:
Revised By: Corporate Quality Systems
3/5/2011 1 of 44
I. CHANGES TO THIS REVISION
Rev,.#5 Changes to text and format for compliance to ISO 9001:2008(E) Fourth
Edition and ISO/TS16949:2009(E) added a not where to refer to ISO 14001
Deletes all references for the requirements of the following: ISO ENIS14001:2004
1c
o Deletes superfluous texts.
42 co II. PURPOSE
fe. This Quality Manual is BAE Systems Products Group's strategic decision to adopt a
4:7-
'(7). ) Quality Management System for conformance and certification to all applicable ISO
Quality Management Systems Requirements.
a.
The content of this Quality Manual applies to BAE Systems Products Group's corporate
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structure which may include any of the various Business Divisions conforming to
rh applicable ISO Quality Management System Requirements.
`3.7 ce For the purpose of this Quality Manual, the BAE Systems Products Group's Business
Divisions and other Corporate Departments will be defined as the"Organization"
(1) throughout the text of this manual.
0 This Manual [Level 1 Document] relates to the"what"that is required for conformance to
0 co applicable ISO Standards.
0
O The Organization's written Process Procedure Instructions [Level 2 Documents] and
ui
Work Instructions [Level 3 Documents] relates to the "how" conformance to applicable
ISO Standards is defined.
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o The Organization shall maintain control records [Level 4 Documents]to provide
O co assurance and evidence that the required product quality is achieved and that the
• 0 Quality Management System has been implemented.
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4, 45
tlApproved By/Date: Control:
a.)
CQS/Date:
t.
Document No.: C-4.2.2-000 Title: Quality Manual
The Organization shall provide the necessary forms that identify the status of materials,
products, equipment and other gages and devices used to achieve the specified
requirements.
Ill. SCOPE
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This Manual incorporates the following elements of ISO Quality Management Systems
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Requirements:
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0) 4- ISO 9001:2008[E]
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2 23 ISO/TS 16949:2002 9[E]
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Note: ISO 14001 Environmental requirements are administered by the Environmental,
c 1)2 Health and Safety group not directly under the control of this QMS.
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For ease of identification, correspondence references between ISO Quality Management
2 -c Systems Requirements, may be color coded as indicated above. Where applicable, text
will be printed in the appropriate color to differentiate the scopes of the applicable
E Quality Management Systems Requirements.
This Quality Manual incorporates the listed ISO Quality Management Systems
Requirements. Organization's Divisions shall certify to only the ISO standard[s]that
-e.
apply to the specific Business Unit's activities. In addition, various BAE System's
.e Products Group entities may not perform all of the functions required by the applicable
ISO Quality Management System Requirements. Where certain functions are not
›- t, performed, exclusion for audit purposes and conformance is accepted. Third party audits
plans should include awareness of any exclusion applicable to the audit.
0 .c.61
0
0 ,c The soft Body Armor and the Ballistic Engineering Systems laboratory have a dedicated
n Quality Manual that conforms to the NIST National Voluntary Laboratory Accreditation
Program, the NIJ Compliance Testing Program. These programs work in unison with
0 fj applicable ISO Quality Management System requirements. When applicable ISO
a requirements satisfy the requirements of the NIST Handbook 150:2006 and or, the NIJ
Compliance Testing Program, they shall be cross referenced in the Ballistic Engineering
CB
0 Systems Quality Manual for compliance to applicable standards.
Z 0
That the applicable Organization's Products Group Entities shall meet the specified
requirements of all ISO International Standards for a Quality Management Systems In
7i addition, to conform to Customer Specific Requirements that link to ISO International
Standards and may be proprietary to the Organization's customers.
GENERAL
0.1 The Organization will adopt the applicable requirement of ISO 9001:2008, clausc 0.1
such requirements will be addressed in the text of this Quality Manual.
Revision No.: 5 Review Date: 3/5/2011 Page 2 of 44
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'
\ Document No.: C-4.2.2-000 Title: Quality tVlanual
-- - — -- -
_
The Organization's aim is to publish a clearly defined Quality Manual that contains and
conforms to all applicable ISO International Standards and any"Customer Specific
Requirements".The Quality Manual shall be a controlled document when issued to
individual Organization Teammates. Other Teammates shall have access to the Quality
---
Manual by electronic computer access.
The Organization will develop and document requirements for a quality and
o
o management system that consistently meets customer, and stet:Idol statutory and
regulatory requirements with the aim to increase customer satisfaction through continual
(i)
improvement of the system and conformity to customer specific and or statutory and
regulatory requirements, applicable to the product*
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ii) 0 The design and implementation of the Organization's Quality Management system
1,-
0 co is influenced by:
4 V Its business environment, changes in that environment, or risks associated
c with that environment.
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IA 0.1 V Its varying needs,
I Its particular objectives,
1 The products it provides,
v The processes it employs,
45 E I Its size and organizational structure.
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„1?„) a 0.2 Process Approach and Lean Enterprise Strategies
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CL co 0.2.1 Process Approach
The Organization, where applicable,will adopt the"Process Approach" methodology
›- '0 when developing, implementing, and improving the effectiveness of a quality
management system and to enhance customer satisfaction by meeting customer
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—
-0 requirements.
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13-1 0 To function effectively,the Organization must identify-determine and manage numerous
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linked activities. An activity or set of activities that use resources and managed in
order to enable the transformation of inputs into outputs can be considered as a
process. Often the output of one process may directly form the input of the next.
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0 0.
0 Management's control of processes provides the linkage between the individual
processes within the system of processes, their combination, and an interaction of
processes is the"Process Approach".
ttAts When used within the Organization's Quality IVIanagement System, "Process Approach"
emphasizes the importance of the following:
-.3
a. Understanding and meeting requirements.
b. Consider processes in terms of added value.
_ _______---------------- _ -------_--------,
Revision No.: 5 Review Date: 315/2011 Page 3 of 44
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I IF7 "
Document No.: C-4.2.2-000 Title: Quality Manual
c. Obtaining results of processes and effectiveness.
d. The continual improvement of processes based on objective
measurement.
(1.) 0.2.2 Lean Enterprise Strategies
0 Basically, Lean Strategies is producing what is needed, when it is needed with a
minimum amount of resources, waste and space.
The application of lean concepts focus on value added activities throughout the
23 Organization by the reduction of waste and performing activities that result in doing it
(13 right the first time.
463
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a.)
$3 .-.3 0.3 Relationship with ISO 9004
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ISO 9001 and ISO 9004 have been developed as a consistent pair of quality
E management system standards which have been designed to complement each other
and can be used independently.
Conformance to ISO 9001 is used for certification. ISO 9004 provides a wider range of
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objectives with focus on continual improvement, effectiveness and efficiency. ISO 9004
is recommended as a guide to move beyond the requirements of ISO 9001. However
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ISO 9004 is not intended for certification.
0.2.-.4 0.4 Compatibility with other Quality Management System Requirements
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This Quality Manual is aligned with all applicable ISO Quality Management System
Requirements in order to enhance the compatibility of such Systems and for the benefit
of the Organization's use.
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( 1,5 0.5 Goal of the Organization's Quality Manual
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c.) n The goal of this Quality Manual is the development of a Quality Management System
Z 0 that provides continual improvement, emphasizing defect prevention and the reduction
of variation and waste in the supply chain
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1.1 General.
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The Organization will demonstrate its ability to consistently provide product that meets
:3 customer and applicable statutory and regulatory requirements and.
Aims to enhance customer satisfaction through the effective application of the system.
Including processes for continual improvement of the system and assurance of
conformity to customer and applicable statutory and regulatory requirements.
Revision No.: 5 Review Date: 3/5/2011 Page 4 of 44
LkIt
Document No.: C-4.2.2-000 Title: Quality Manual
Note. On this document when mentioned the term "product" it only applies to
• Product intended for, or required by, a customer,
• Any intended output resulting from the product realization process
Note. Statutory and regulatory requirements can be expressed as legal requirement
E
ISO/TS 16949:2009 in conjunction with ISO 9001:2008 defines the Quality Management
a System requirements for the design and development, production and relevant,
installation and service of Automotive-related products.
• 1E
O 44-
• o The Technical Specification is applicable to sites of the organization where customer-
specified parts, for
o a) production and/or service, are manufactured.
a) a
Supporting functions, whether on-site or remote (such as design centres, corporate
c headquarters and
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'Fri CU distribution centres), form part of the site audit as they support the site, but cannot obtain
'5 -c stand-alone
c certification to this Technical Specification.
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• E This Technical Specification can be applied throughout the automotive supply chain.
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412 C
• 1-1-1 2 Normative Reference
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•c..7 11 •
C
-c This Quality Manual, through references in the text, constitutes the provisions of
3 § applicable. ISO Quality Management System Requirements. The Organization will apply
›- the most recent editions of relevant Quality Management Requirement as they become
effective.
0 1.15
(,)
.c 3 Terms and Definitions
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For the purpose of this Quality Manual, the terms and definitions given in ISO 9000 shall
O 70-
tr apply. Throughout this document wherever the term "product" it can also means
5 8 "service"
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O 0 3.1 Terms and Definitions for the Automotive Industry
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This Quality Manual shall use the additional terms and definitions specific to the
automotive industry and contained in the applicable Quality Management Systems
Requirements publications
IV. PROCEDURES
4. Quality Management System
4.1 General Requirements
Revision No.: 5 Review Date: 3/5/2011 Page 5 of 44
s w• gif
Document No.: C-4.2.2-000 Title: Quality Manual
The Organization shall establish, document, implement document and
maintain a Quality Management System and continually improve its
effectiveness, for conformance to ISO 9001:2008[E], ISOfT'S 16949:2002 9 [El,
and if applicable, other Customer Specific Requirements,
a„)
P. The Organization 'I-identify shall determine processes and implement such
processes of a Quality Management System throughout all applicable
Organization Business Divisions and Departments. In addition, the Organization
will identify determine the sequences and interactions of processes. Sequences
(ti and Interactions with other ISO Quality Management Systems may be indicated
0 in the right margins and color coded as indicated in Section II, Introduction.
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The Organization will ensure that effective control of such processes are
measured monitored, measured where applicable,and analyzed these
c,f)
o processes and implement actions necessary to achieve planned results for
(i) continual improvement.The Organization shall provide the resources required to
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carry out all processes required of the Quality Management System.
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and-eentnual-imrevement
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The Organization will ensure the control of outsourced material, products and
services.
The Organization will document supplier processes and document supplier
compliance to Organization's Quality Management System. This shall include
...al any customer specific requirements.
4.1.1 General Requirements-Supplemental
111 (I)
Ensuring control over outsourced processes shall not absolve the Organization of
the responsibility of conformity to all customer requirements.
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u 4.2 Documentation Requirements
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0 a 4.2.1 General
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-o Documentation of the Quality Management System shall include: tne-fellewinC
a. Documented statement of the Quality Policy and the Quality
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(3„) Objectives
b.
All-levels-eflo matiehal
,Sandads4eud4i4ls Quality Manual.
c Documented evideneeffe6tiv lannint—Revision No.: 5 Review Date: 3/5/2011 Page 6 of 44
Document No.: C-4.2.2-000 Title: Quality Manual
procedures and records required by current applicable Standard,
and.
d. Proccdurca:-Documents, including records, determined by
the Organization to be necessary to ensure the effective
planning, operation and control of its process.
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Note I Where the term "documented procedures" appears within
this document, this means that the procedure is established,
2) documented, implemented and maintained, a single document
o co may address the requirements for one or more procedures, a
o.) 0 requirement for a documented procedure may be covered by
c more than one document.
o 44-7
Note 2 The extend of the Quality management System
—
documentation can differ from one organization to another.
°
4.2.2 Quality Manual
143 E
The Organization shall provide, establish and maintain a Quality Manual that
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(i) includes the scope of the Quality Management System, referenced to
C documented procedures.
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The Organization will identify the sequences and interactions between processes
;v.
of the Quality Management System. For ease of identification and understanding
of the sequences and interactions, the Organization, where applicable, will
41-1 provide flow charts,which will graphically show such linkage of sequences and
O interactions between processes.
tti 4.2.3 Control of Documents
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O —12 The Organization's control of documents shall include the following:
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a. Approval of document for adequacy prior to issue.
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• 0 b. Review, update, and re-approve documents as necessary.
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c. To ensure that changes and the current revision status of
documents are identified.
d. Ensure the approved and current documents are legible and
readily identifiable and available at the point of use athaf either
by hard copies or electronic computer imaging.
e. Ensure that documents of external origin determined by the
Organization to be necessary for the planning and operation
Revision No.: 5 Review Date: 3/5/2011 Page 7 of 44
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Document No.: C-4.2.2-000 Title: Quality Manual
of the Quality Management System are identified and their
distribution controlled.
e. Prevent the unintended use of obsolete documents, and identify
obsolete documents if they are retained for any purpose.
a)
4.2.3.1 Engineering Specifications
The Organization shall have a process to assure the timely review,
distribution and implementation of all customer engineering
0 4- standards/specifications based on the customer's required schedule. The
0
Q.) a) timeliness of the review shall not exceed two working weeks.
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a) 1a The Organization shall maintain a record of the date on which each change is
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c implemented in production including updated documents. Changes shall also
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be reviewed for updating of other documents that link to such changes.
cn (1)
4.2.4 Control of Records
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E Records shall bo established aneknai4tained to provide evidence of conformity to
requirements and of the effective operation of the Quality Management System
tu shall be controlled. Records shall remain legible, readily identifiable and
retrievable. A documented procedure shall be established to define the controls
needed for the identification, storage, protection, retrieval, retention time and
disposition of records.
4.2.4.1 Records Retention
O r• t, The retention of records shall satisfy statutory, regulatory and customer
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O .c requirements
5.0 Management Responsibility
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i•-• 0 Top Management shall be responsible for conformance to all applicable ISO
Z 0 Quality Management Systems Requirements.
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Z 0 5.1 Management Commitment
Top Management's commitment is confirmed in the cover letter to this
Quality Manual and incl doc ac a minimum: continually improving its
effectiveness by:
a. Communicating to the organization the importance of meeting
customer as well as statutory and regulatory requirements.
b. Establishing the Quality Policy.
, Revision No.: 5 Review Date: 3/5/2011 Page 8 of 44
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Document No.: C-4.2.2-000 Title: Quality Manual
c. Ensuring that quality objectives are established.
d. Conducting management reviews.
e. Ensuring the availability of resources.
(.1.)
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5.1.1 Process Efficiency
Top management shall review the product realization processes and the support
.4- processes to assure their effectiveness and efficiency.
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co 5.2 Customer Focus
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o 474: Top management shall ensure that customer requirements are determined and
V) a) are met with the aim of enhancing customer satisfaction.
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a 5.3 Quality Policy
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DEDICATED TO EXCELLENCE IN ALL OF OUR
PROCESSES, PRODUCTS, AND SERVICES
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Top Management shall ensure that the quality Policy.
a. is appropriate to purpose of the Organization.
b
includes a commitment to comply with requirements and
0 8 continually improve the effectiveness of the Quality
0 ti-3 Management System.
0 ,a Provides a framework for establishing and reviewing Quality
tu Objectives.
dIs communicated and understood within the Organization,
and
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0 (t) e is reviewed for continuing suitability.
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The Quality Policy also includes the following commitments to:
a. Implementing the "Process Approach" methodology and Lean
(.1) Enterprise Strategies
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d. Complying with relevant legislations and regulations and with
other requirements to which the Organization subscribes.
e. Documenting and reviewing quality objectives and requirements.
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Document No.: C-4.2.2-000 Title: Quality Manual
f. Implementing, maintaining, and communicating the Policy to all
Safariland teammates and ensuring that it is understood.
g- Making our Quality Objectives available as public record.
"EXCELLENCE IN ALL OF OUR PROCESSES, PRODUCTS, AND
SERV10E..,,
Includes all aspects of the above listed controls that are necessary to the
achievement of
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0) "EXCELLENCE".
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(1,) a The Policy and its requirements shall be included in all levels of written
documents, where applicable and with conformance to applicable ISO
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International Standards. Our objectives and commitments are updated or
(1)
renewed annually through the Business Plans.
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5.4 Planning
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5.4.1 Quality Objectives
a) 0
The Organization's Quality Objectives are established in the annual Business
ce
Planning Meeting and may be reviewed periodically through Management
Reviews.
In addition, Quality Objectives shall be established for all the Organization's
.• 11• ) Business Divisions, Departments and their relevant functions and at all levels
O La within the Organization's operations. Such objectives are contained in each
O .c Division and Department's annual business plan or in documented Goals and
in 0) Quality Objectives.
7• 2' Objectives shall be measurable and documented for the attainment of such
1.4 c4.5
I— 0 objectives.
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0 0 Objectives shall be reviewed at planned intervals, usually through Management
Z 0 Reviews completed during scheduled Management Strategic Review meetings.
Quality objectives may change as objectives are met. Quality Objectives may
recycle with tightened parameters that show continual improvement and indicate
both internal and external customer satisfaction.
5.4.1.1 Quality Objectives-Supplemental
Top Management shall define quality objectives and measurements that shall be
included in the Automotive Business Plan and used to deploy the quality policy
and achieve customer expectations within a defined period of time.
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Document No.: C-4.2.2-000 Title: Quality Manual
5.4.2 Quality Management System Planning
Planning of the Quality Management System shall be carried out in order to meet
the Quality Policy and to meet the requirements as stated in section 4.1 of
ISO 9001:2008 and ISO T/S 16949:2002 9 [E].
a)
z The integrity of the Quality Management System shall be maintained when
changes to the Quality Management System are planned and implemented
5.5 Responsibility, Authority and Communication.
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a) The responsibility for implementation of the Quality System is assigned to all levels of
0 2 management so that all Teammates are aware of and understand the Quality System and
(1.) their activities that contribute to achievement of such Quality requirements.
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u) 5.5.1 Responsibility &Authority
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2.) c
Top Management shall ensure that responsibilities and authorities are
o defined and communicated within the Organization.
a) E
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-ci 5.6.1.1 Responsibility for Quality
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• 1.11
Managers with responsibility and authority for corrective action shall be
promptly informed of products or processes which do not conform to
.c requirements.
›- "t1 Production operations across all shifts shall be staffed with personnel in
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O charge of, or delegated responsibility for ensuring conformity to product
0 requirements.
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tu Teammates, responsible to conformity to product requirements, and who
manage, perform and verify work affecting quality issues shall have the
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• t organizational freedom and authority to:
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O (/) a. Initiate action to prevent the occurrence of non-conformities relating to
0 a product, processes, and quality systems.
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b. identify and record any problem relating to the product, process and the
quality system.
U) c. Initiate, recommend, or provide solutions through designated channels.
d. Verify the implementation and effectiveness of solutions.
e. Control further processing or delivery of non-conforming product until
corrective action is initiated, implemented, and verified for permanence
and effectiveness.
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[ Document No.: C-4.2.2-000 Title: Quality Manual
5.5.1.1 Responsibility for Quality
Managers with responsibility and authority for corrective action shall be promptly
informed of products or processes, which do not conform to requirements.
Personnel responsible for conformity to product quaky requirements shall have
a the authority to stop production to correct quality problems.
(f)
ai 1E, Production operations across all shifts shall be staffed with personnel in charge
ch 4" of, or delegated responsibility for, ensuring conformity to product quaky
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a) a) requirements
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(1) 5.5.2 Management Representative.
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0 a) The Management Representative responsibility is assigned to the Quality
"> Manager.
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tc;)) The management representative shall insure the Quality
a) E Systems are established, implemented, maintained and conform to ISO
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-6 9001:20OG 8 and ISO/TS 16949:2002 9 [E).
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The management representative shall report, for management's review the
performance of the Quality Systems as a basis for improvement of the Quality
• -c Systems.
And ensuring the promotion of awareness of Customer requirements
>- 7:1 throughout the Organization.
a. 0)
a 2
The management representative has the responsibility for dealing with external
,c parties on matters relating to the Systems.
11.1
.-1 5.5.2.1 Customer Representative
o Top management shall designate personnel with responsibility and authority to
O w ensure that customer requirements are addressed. This includes selection of
(.> a special characteristics, setting quality objectives and related training, corrective
Z 0
and preventive actions, product design and development.
5.5.3 Internal Communication
Top Management shall ensure appropriate communication processes are
established within the organization and that communication takes place
regarding the effectiveness of the Quality Management System.
5.6 Management Review
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Document No.: C-4.2.2-000 Title: Quality Manual
5.6.1 General
The Organization establishes and reviews Corporate Goals annually via the
Corporate Strategic Planning Session or at another time or place at the discretion
of top management. The Quality Policy is at the forefront of all Corporate Goals.
The Organization's top management will review the Quality objectives and goals
o for continuing suitability and effectiveness in satisfying the requirements of ISO
9001:2000 8 [EL and ISOfTS 16949-2002 9 [E].
f.
The Quality Manager, or designee, will present such reviews that shall be
included in Review Inputs and Review Outputs. The review shall also include
assessing the opportunities for improvement—these assessments shall be
ce recorded as part of the review.
7) 0 5.6.1.1 Quality Management System Performance
°c These reviews shall include all requirements of the quality management system
41"
and its performance trends as an essential part of the continual improvement
(I) E process.
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in Part of the management review shall be the monitoring of quality objectives, and
. ILl the regular reporting and evaluation of the cost of poor quality.
61 IX
These results shall be recorded to provide, as a minimum, evidence of
achievement of the quality objectives specified in the Automotive Business Plan
>"- -C3 and customer satisfaction with product supplied.
O 5.6.2 Review Input
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0.) Management Reviews shall include but not limited to the following:
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r a. Results of audits.
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b. Customer feedback.
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• 0 c. Process performance and product conformity.
4, 43
d. Status of preventive and corrective actions.
e. Follow-up actions from previous management reviews.
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f. Changes that could affect the Quality Management System.
g. Recommendations for improvement.
5.6.2.1 Review Input-Supplemental
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Document No.: C-4.2.2-000 Title: Quality Manual
Inputs to management review shall include an analysis of actual and potential
field-failures and their impact on quality, safety or the environment,
4E" 5.6.3 Review Output
(i)
Outputs from Management Reviews shall include any decisions or actions
o related to the following:
(i)
a. Improvement of the effectiveness of the Quality Systems and its
processes.
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(L) 113
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(a a
C C. Resource needs.
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6.0 Resource Management
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— 0 6.1 Provision of Resource
The Organization shall provide resources essential to the implementation and
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c control of the Quality Management Systems. Resources include human
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resources, specialized skills, technology and financial resources including the
following:
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a. To implement and maintain the Quality System
And continually improve its effectiveness.
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55 b. To enhance customer satisfaction by meeting customer requirements.
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tu 6.2 Human Resources
0 72- 6.2.1 General
o Personnel performing work affecting conformity to product requirements control
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shall be competent on the basis of appropriate education, training, skills and
z0 experience.
6.2.2 Competence, Training and Awareness
The Organization shall:
a. Determine the necessary competence for Teammates performing work
affecting product requirements and quality control.
b. Where applicable provide training or take other actions to satisty=sizieli
needs. Achieve the necessary competence
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Document No.: C-4.2.2-000 Title: Quality Manual
c. Evaluate the effectiveness of the actions taken.
d. Ensure that all Teammates are aware of the relevance and importance of
4E' their activities and how they contribute to the achievement of the quality
objectives.
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e. Maintain appropriate records of education, training, skills and experience.
(r)
ai 6.2.1.1 Product Design Skills
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el) The Organization shall ensure that personnel with product design responsibility
are competent to achieve design requirements and are skilled in applicable tools
49
a) 0 and techniques.
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Applicable tools and techniques shall be identified by the Organization.
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6.2.2.2 Training
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• E The Organization shall establish and maintain documented procedures for
49,
identifying training needs and achieving competence of all personnel performing
a) activities affecting conformity to product requirements etuality, Teammates
performing specific assigned tasks shall be qualified, as required, with particular
a. attention to the satisfaction of customer requirements.
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This applies to all Teammates having an effect on quality at all levels of the
>. a Organization. In addition, training shall be provided to ensure customer specific
a. w
requirements are met,
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o .c 6.2.2.3 Training on the Job
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The Organization shall provide on the job training for Teammates in any new or
O 1- 5, modified job affecting conformity to product requirements quality, including
1.•-• 0 contract or agency personnel. Teammates whose work can affect quality shall be
informed about the consequences to the customer of nonconformity to quality
0 (i)
0 requirements.
6.2.2.4 Employee Motivation and Empowerment
The Organization shall have a process to motivate Teammates to achieve quality
objectives, to make continual improvements, and to create an environment to
promote innovation. The process shall include the promotion of quality and
technological awareness throughout the whole organization.
The Organization shall have a process to measure the extent to which its
Teammates are aware of the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives,
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Document No.: C-42.2-000 Title: Quality Manual
6.3 Infrastructure
The Organization shall determine, provide and maintain the infrastructure needed
to achieve conformity to product requirements.
(1,) may-lse Infrastructure include, as applicable:
a. Buildings, workspace and associated utilities.
b. Process equipment, machinery including hardware and software.
• o
t43) c. Supporting services such as transport, communication or
o co information systems,
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6.3.1 Plant Facility and Equipment Planning
The Organization shall use a multidisciplinary approach for developing plant,
• c facility and equipment plans. Plant layouts shall optimize material travel, handling
:4--
and value-added use of floor space, and shall facilitate synchronous material
E flow. Methods shall be developed and implemented to evaluate and monitor the
co
effectiveness of existing operations.
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In addition, these requirements should focus on lean manufacturing principles
Q. and the link to the effectiveness of quality,
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6.3.2 Contingency Plans
'4) The Organization shall prepare contingency plans to satisfy customer
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shortages, key equipment failures and field returns.
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6.4 Work Environment.
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The Organization shall determine and manage the workplace environment
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The protection and safety of all Teammates.
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b. Climate control.
c. Maintenance of machinery and equipment so if breakdowns occur
there will be minimum effect on Teammates production capability
and other resources.
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6.4./ eammate Personnel Safety to Achieve conformity to Product
requirements
Product safety and the means to minimize potential risks to Teammates shall be
addressed by the Organization especially in the design and development process
and in manufacturing process activities,
6.4.2 Cleanliness of Premises
IS, The Organization shall maintain its premises in a state of order, cleanliness and
0 4_, repair consistent with the product and manufacturing process needs.
2 611
42 03 7.0 Product Realization.
C 14. 7.1 Planning of Product Realization.
*>, The Organization shall plan and develop the processes needed for product
c realization. Planning of product realization shall be consistent with the
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tr. requirements of the other processes of the Quality Management System.
The Organization's planning for product realization shall "
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a) determine as may be required:
a. Quality objectives and requirements for the product.
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b. The need to Establishment of processes documents and provide
resources specific to the product.
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measurement, inspection and testing specific to the product and
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realization processes and resulting product and the output of the
0 planning meet requirements.
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Customer requirements and references to its technical specifications shall be
included in the planning of product realization as a component of the quality plan.
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7.1.2 Acceptance Criteria
Acceptance criteria shall be defined by the Organization and, where required,
approved by the customer. For attribute data sampling, the acceptance level
shall be zero defects.
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.1;41
S Fik,
i Document No.: C-4.2.2-000 Title: Quality Manual
7.1.3 Confidentiality
The Organization shall ensure the confidentiality of customer-contracted products
and projects under development, and related product information.
-:111
7.1.4 Change Control
ai The Organization shall have a process to control and react to changes that
impact product realization. The effects of any change, including those changes
o
2 ow caused by any supplier, shall be assessed, and verification and validation
o activities shall be defined, to ensure compliance with customer requirements.
a) Changes shall be validated before implementation.
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For proprietary designs, impact on form, fit and function, including performance
and or durability, shall be reviewed with the customer so that all effects can be
c properly evaluated.
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-6 465 notification to, and agreement from the customer. This requirement applies to
c) product and manufacturing process changes.
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TE1C4 7.2 Customer Related Processes
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7.2.1 Determination of Requirements Related to the Product.
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a. u The Organization shall determine the following:
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delivery and post-delivery activities.
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t 0 intended use, where known.
0 c. Statutory and regulatory requirements golated Applicable to the product
including the activities, products or services.
e. The Organization shall identify any additional requirements considered
necessary such as customer specific requirements and those specifically
identified by Safariland.
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The Organization's post delivery activities to the customer may include any after-
sales product service provided as part of the customer contract or purchase
order.
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* F4t!lL*NIJI
'
Document No.: C-4.2.2-000 Title: Quality Manual
This requirement includes recycling, environmental impact and characteristics
identified as a result of the Organization's knowledge of the product and
manufacturing processes.
Conformance to the above item, Statutory and Regulatory requirements, includes
all applicable government, safety and environmental regulations, applied to
acquisition, storage, handling, recycling, elimination or disposal of materials.
7.2.1.1 Customer Designated Special Characteristics
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The Organization shall demonstrate conformity to customer requirements for
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a.) 7,2.2 Review of Requirements Related to the Product.
O• 147
• a) The Organization shall review the requirements related to the product. Such
-c review will be conducted prior to a commitment to supply the product to the
customer and shall include but not limited to the following:
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E a. Product requirements are defined.
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C W is resolved.
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(1.)• C c. That the Organization has the ability to meet the defined requirements.
>. Records of the results of the review and actions arising from the review shall be
r.L. (LI maintained.
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confirm the customer requirements before acceptance.
0 T2 Where product requirements are changed, the Organization shall ensure that
t— a relevant documents are amended and that relevant personnel are made aware of
Z o the changed requirements.
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objectives and targets, such issues shall be resolved with the customer before
acceptance of the customer's order.
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7.2.2.1 Review of Requirements Related to the Product-Supplemental
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Waiving of any requirement contained in paragraph 7.2.2 shall require customer
authorization.
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11.„
Document No.: C-4.2.2-000 Title: Quality Manual
7.2.2.2 Organization's Manufacturing Feasibility
The Organization shall investigate, confirm and document the manufacturing
feasibility of the proposed products in the contract review process, including risk
analysis.
7.2.3 Customer Communication.
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The Organization shall determine and implement effective processes for
communicating with customers in relation to:
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23 a. Product Information.
b. Inquires, contracts or order handling, including amendments.
174
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c 7.2.3.1 Communication-Supplemental
The Organization shall have the ability to communicate necessary information,
including data, in a customer specified language and ferment such as, computer
0.) o aided design, electronic data exchange etc.
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7.3 Design and Development
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Note: The requirements of 7.3 include product and manufacturing process design and
"c development, and focus on error prevention rather than detection.
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The Organization shall plan and control the design and development of product.
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During the design and development planning, the Organization shall determine:
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'(13 each Design and Development stage.
c. The responsibilities and authorities for Design and Development.
The Organization shall manage the interfaces between different groups involved
in design and development to ensure effective communication and clear
assignment of responsibility.
Planning output shall be updated, as appropriate, as the design and development
progresses.
Review Date: 3/5/2011
Revision No.: 5 Page 20 of 44
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7.3.1.1 Multidisciplinary Approach
The Organization shall use a multidisciplinary approach to prepare for product
4E' realization including:
a. Development, finalization and monitoring of special characteristics
b. Development and review of FMEA's including actions to reduce
ai potential risks.
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13 0 A multidisciplinary approach typically includes the departments of the
c L- Organization's Design & Development, Manufacturing, Engineering, Quality,
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Production, and other appropriate Teammates.
c 7.3.2 Design and Development Inputs.
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maintained. Tiles°The inputs shall include:
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d. Other requirements essential for design and development.
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These inputs shall be reviewed for adequacy. Requirements shall be complete,
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0 0 7.3.2.1 Product Design Input
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(• T) The Organization shall identify, document and review the product design inputs
requirements, including the following:
Customer requirements in the contract review, special characteristics,
-c- identification, traceability and packaging.
The Organization shall have a process to deploy information gained from
previous design projects, computer analysis, supplier feedback, internal input,
field data, and other relevant sources for current and future project of similar
nature.
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41..,,Ent31.1_
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Targets for product quality requirements, life, reliability, durability,
maintainability, timing and cost,
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7.3.2.2 Manufacturing Process Design Input
• :E The Organization shall identify, document and review the manufacturing
process design input requirements including:
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a) a
c b. Targets for productivity, process capability and cost.
c. Customer requirements, if any.
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7.3.2.3 Special Characteristics
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The Organization shall identify and include special characteristics in the control
plan.
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The Organization shall comply with customer specified definitions and symbols.
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The Organization shall identify process control documents including drawings,
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• .c characteristic symbol or the Organization's equivalent symbol or notation to
w include those process steps that affect special characteristics.
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,c) parameters.
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O 7.3.3 Design and Development Outputs.
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The outputs of design and development shall be tagAiteled in a form suitable for
that=enables verification against the design and development input and shall be
approved prior to release.
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Design and development outputs shall:
a. Meet the input requirements for design and development.
b. Provide appropriate information for purchasing, production and for
service provision as may be required.
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c. Contain or reference product acceptance criteria.
d. Specify the characteristics of the product that are essential for its
safe and proper use.
Note: Information for production and service provision can include
details for the preservation of the product
• 4-- 7.3.3.1 Product Design Outputs-Supplemental
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S2 (0 The product design output shall be expressed in terms that can be verified and
0 0 validated against product design input requirements. The product design output
c shall include:
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Product error proofing as appropriate.
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data'
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f. Diagnostic guidelines where applicable,
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7.3.3.1 Manufacturing Process Design Output
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• ,c The manufacturing process design output shall be expressed in terms that can
tit be verified against manufacturing process design input requirements and
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validated. The manufacturing process design output shall include:
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e. Work instructions.
44
f. Process approval acceptance criteria.
g. Data for quality reliability, maintainability and measurability.
IRevision No.: 5 Review Date: 3/5/2011 Page 23 of 44
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ft Result of error proofing activities, as appropriate.
Methods of rapid detection and feedback of product/manufacturing
process nonconformities.
4.) 7.3.4 Design and Development Review.
At suitable stages, systematic reviews of design and development shall be
performed in accordance with planned arrangements and the following:
a. To evaluate the ability of the results of design and development to
fa.) meet requirements.
b. Identify problems and propose necessary actions.
11.5
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with the design and development stages being reviewed. Records of the results
T. c of the reviews and any necessary actions shall be maintained.
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include manufacturing process design and development.
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Measurements at specified stages of design and development shall be defined,
analyzed, and reported with summary results as an input to Management
Review.
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O ,a others, as appropriate.
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7.3.5 Design and Development Verification.
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Verification shall be performed in accordance with planned arrangements to
Z o ensure that the design and development outputs have met the design and
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0 any necessary actions shall be maintained.
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7.3.6 Design and Development Validation.
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(t) Design and development validation shall be performed in accordance with
planned arrangements to ensure that the resulting product is capable of meeting
the requirements of the specified application or intended use. Wherever
practicable, validation shall be completed prior to the delivery or implementation
of the product. Records of the results of validation and any necessary actions
shall be maintained.
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Note: The validation process normally includes an analysis of field reports for
similar products.
Note: The verification and validation processes apply to both product and
manufacturing processes.
7.3.6.1 Design and Development Validation-Supplemental
Design and development validation shall be performed in accordance with
customer requirements including program timing.
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2 (c9 7.3.6.2 Prototype Program
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When required by the customer, the Organization shall have a prototype program
and control plan. The Organization shall use, wherever possible, the same
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To a) suppliers, tooling and manufacturing processes as will be used in production.
c All performance testing activities shall be monitored for timely completion and
conformity to requirements.
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While services may be outsourced, the Organization shall be responsible for the
p outsourced services, including technical leadership.
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a) 7.3.6.3 Product Approval Process
The Organization shall conform to a product and manufacturing process approval
procedure recognized by the customer.
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111 process.
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This product and manufacturing process approval procedure shall also be
O T2 applied to the Organization's suppliers.
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7.3.7 Control of Design and Development Changes.
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Z 0 Design and development changes shall be identified and records maintained.
The changes shall be reviewed, verified, and validated, as appropriate, before
implementation. The review of design and development changes shall include
evaluation of the effects of the changes on constituent parts and product already
delivered.
Records of the results of the review of changes and any necessary actions shall
be maintained.
Note: Design and development changes include all changes during the product
program life.
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I Document No.: C-4.2.2-000 Title: Quality Manual
7.4 Purchasing.
7.4.1 Purchasing Process.
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(I) The Organization shall ensure that purchased product conforms to specified
purchase requirements. The type and extent of control applied to the supplier
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and the purchased product shall be dependent upon the effect of the purchased
product on subsequent product quality and realization of the final product.
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The Organization shall evaluate and select suppliers based on their ability to
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supply product in accordance with the Organization's requirements. Criteria for
S2 co selection, evaluation, and re-evaluation shall be established. Records of the
su a results of evaluations and any necessary actions arising from the evaluation shall
C be maintained.
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Note: Purchased products include all products and services that affect customer
a). c requirements such as sub-assembly, sequencing, sorting, rework and calibration
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-6 465' Note: When there are mergers, acquisitions, or affiliations associated with
a.) 0 suppliers, the Organization should verify the continuity of the supplier's quality
w management system and its effectiveness.
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(1) 7.4.1.1 Statutory and Regulatory Conformity
>- All purchased products or materials used in products shall conform to applicable
statutory and regulatory requirements.
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O 1,,t development with the goal of supplier conformity to ISO/TS 16949:2002 9[E].
I-• a Conformity with ISO 9001:2008 is the first step in achieving this goal.
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(.) 0 The prioritization of suppliers for development depends upon, for example, the
0 supplier's quality performance and the importance of the product supplied.
Unless otherwise specified by the customer, suppliers to the Organization shall
be third party registered to ISO 9001:2008 by an accredited third-party
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certification body.
7.4.1.3 Customer Approve Sources
Where specified by the contract with a customer, The Organization shall
purchase products, materials or services from approved sources.
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Document No.: C-4.2.2-000 Title: Quality Manual
The use of customer designated sources, including tool/gauge suppliers, does
not relieve the Organization of the responsibility for ensuring the quality of
purchased products.
7.4.2 Purchasing Information.
(t)
Purchasing information shall describe the product to be purchased, including
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where appropriate the following:
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a. Requirements for approval of product, procedures, processes and
equipment.
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c. Quality Management System Requirements.
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c requirements prior to their communication to the supplier.
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• E 7.4.3 Verification of Purchased Product
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4.) a The Organization shall establish and implement the inspection or other activities
4E' Lu necessary for ensuring the purchased product meets specified purchase
requirements.
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Where the Organization or its customer intends to perform verification at the
• "c supplier's premises, The Organization shall state the intended verification
EL (1) arrangements and method of product release in the purchasing information.
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• .c 7.4.3.1 Incoming Product Quality conformity to requirements..
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The Organization shall have a process to assure the quality of purchased product
79
1 utilizing one or more of the following methods:
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a. Receipt of, and evaluation of, statistical data by the Organization,
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performance.
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Second or third party assessment or audit of supplier sites, when
coupled with records of acceptable delivered product. Conformity
to requirements
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d. Part evaluation by a designated laboratory,
d. Another agreed to with the customer.
I Revision No.: 5 Review Date: 3/5/2011 Page 27 o'‘.1=4=-1.
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7.4.3.2 Supplier Monitoring
Supplier performance shall be monitored through the following indicators:
a. Delivered product quality.conforrnity to requirements
b. Customer disruptions including field returns.
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c. Delivery performance including incidents of premium freight.
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d, Special customer notifications related to quality of delivery issues.
O cia The Organization shall promote supplier monitoring of the performance of their
461. manufacturing processes.
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C 7.5 Production and Service Provision.
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(1) E 7.5.1 Control of Production and Service Provision.
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(1) The Organization shall plan and carry out production and service provision under
controlled conditions. Control conditions shall include the following:
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-• C a. The availability of information that describes the characteristics of
the product.
b. The availability of work instructions, as necessary.
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d. The availability and use of monitoring and measuring equipment
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t— ae The implementation of monitoring and measurement.
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7.5.1.1 Control Plan
The Organization shall develop control plans at the system, subsystem,
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component, and/or material level for the product supplied, including those for
processes producing bulk materials as well as parts.
In addition, the Organization shall develop a control plan for pre-launch and
production that takes into account the design FMEA and manufacturing process
FMEA outputs.
Revision No.: 5 Review Date: Miami Page 28 of 44
Tit
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Document No.: C-4.2.2-000 Title: Qualit Manual
The control plan shall:
a. List the controls used for the manufacturing process control.
a) b. Include methods for monitoring of control exercise over special
z characteristics defined by both the customer and Safariland.
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c. Include any customer required information.
co 4- d. Initiate the specified reaction plan when the process becomes
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a) 0 Control plans shall be reviewed and updated when any change affecting product,
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c manufacturing process, measurement, logistics, supply sources or FMEA.
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cn o.) Customer approval may be required after review or update of the control plan
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The Organization shall prepare documented work instructions for all Teammates
41,) having responsibilities for the operation of processes that impact conformity to
c product requirements quality,These instructions shall be accessible for use at
Q. the workstation.
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This instruction shall be derived from sources such as the quality plan, the
control plan and the product realization process.
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(,) Job set-ups shall be verified whenever performed, such as an initial run of a job,
material changeover, or job change.
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1— a Work instructions shall be available for set-up Teammates. The Organization
shall use statistical methods of verification where applicable.
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7.5.1.4 Preventive and Predictive Maintenance
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The Organization shall identify key process equipment and provide resources for
machine/equipment maintenance and develop an effective planned total
preventive maintenance system. As a minimum, this system shall include the
following:
a. Planned maintenance activities.
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b. Packaging and preservation of equipment, tooling and gauging.
c. Availability of replacement parts for key manufacturing equipment.
d. Documenting, evaluating, and improving maintenance objectives.
The Organization shall utilize predictive maintenance methods to continually
c.)
improve the effectiveness and the efficiency of production equipment.
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:c 7.5.1.5 Management of Production Tooling
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The Organization shall provide resources for tool and gauge design, fabrication
(iu and verification activities.
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The Organization shall establish and implement a system for production tooling
147:
• management including:
c a. Maintenance and repair facilities and personnel.
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e. Tool design modification documentation, including engineering
-a change level.
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Cl) g. Tool identification, defining status, such as production, repair or
disposal.
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17 0 The Organization shall implement a system to monitor these activities if any work
is outsourced. This requirement also applies to the availability of tools for service
0 to
c) 0 parts.
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7.5.1.6 Production Scheduling
.70 Production shall be scheduled in order to meet customer requirements, such as
just-in-time supported by an information system that permits access to production
information at key stages of the process and is order driven.
7.5.1.7 Feedback of Information from Service
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Document No.: C-4.2.2-000 Title: Quality Manual
A process for communication of information on service concerns to
manufacturing, engineering and design activities shall be established and
maintained.
The intent of service concerns is to ensure that the Organization is aware of
nonconformities that al occurs outside to the of its Organization.
7.5.1.8 Service Agreement with Customers
When and if there is a service agreement with customers, the Organization shall
verify the effectiveness of the following:
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b. Any special purpose tools or measuring equipment.
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'> c. The training of service Teammates.
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0) a The Organization shall validate any processes for production and service
C U.I provision where the resulting output cannot be verified by subsequent monitoring
17.1* or measurement, and as a consequence deficiencies become apparent only after
the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned
a. results.
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The Organization shall establish arrangements for these processes including, as
(i) applicable:
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b. Approval of equipment and qualification of personnel.
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„ 43
d. Requirements for records,
e.(f)
Revalidation.
7.5.2.1 Validation of Processes for Production and Service Provision
Supplemental
The requirements of 7.5.2 shall apply to all processes for production and service
provisions.
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_
7.5.3 Identification and Traceability.
The Organization shall identify the product by suitable means throughout product
realization.
The Organization shall identify the product status with respect to monitoring and
measurement requirements.
ei Where traceability is a requirement (for example, all automotive products), the
Organization shall control and record the unique identification of the product.
T. 133
7.5.4 Customer Property.
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The Organization shall exercise care with customer property while it is under the
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. Q.) Organization's control or being used by the Organization. The Organization shall
identify, verify, protect, and safeguard customer property provided for use or
2 incorporation into the product. If any customer property is lost, damaged or
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‘F- otherwise found to be unsuitable for use, this shall be reported to the customer
and records maintained.
0.) Note: Customer property can include intellectual property, personal data
and customer owned returnable packaging.
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7.54.1 Customer Owned Production Tooling
0 -tj Customer-owned tools, manufacturing, test, inspection tooling and equipment
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shall be permanently marked so that the ownership of each item is visible, and
b-
in ,c can be determined.
7.5.5 Preservation of Product.
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I'm 0 The Organization shall preserve the conformity of product during internal
processing and delivery to the intended destination in order to maintain
0 („0
0 (3 conformity to requirements. This preservation shall include identification,
U handling, packaging, storage and protection. Preservation shall also apply to the
jj constituent parts of a product.
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7.5.5.1 Storage and Inventory
o.)
In order to detect deterioration, the condition of product in stock shall be
assessed at appropriate planned intervals.
The Organization shall use an inventory management system to optimize
inventory turns over time and assure stock rotation such as 'first-in-first-out',
! Revision No.: 5 Review Date: 3/5/2011 Page 32 of 44
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Document No.: C-42.2-000 Title: Quality Manual
(FIFO) Obsolete product shall be controlled in a similar manner to nonconforming
product.
7.6 Control of Monitoring and Measuring Equipment
(i) The Organization shall determine the monitoring and measurement to be
undertaken and the monitoring and measuring equipment needed to provide
o evidence of conformity of product to determined requirements.
The Organization shall establish processes to ensure that monitoring and
(.0 measurement can be carried out and are carried out in a manner that is
consistent with the monitoring and measurement requirements.
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0.) a Where necessary to ensure valid results, measuring equipment shall:
7) (I) a. Be calibrated or verified or both, at specific intervals, or prior to
'› -r use, against measurement standards traceable to international or
c national measurement standards. Where no such standard exist,
the basis used for calibration or verification shall be recorded (see
4.2.4)
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ci b. Be adjusted or re-adjusted as necessary.
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c. Have identification in order to determine its calibration status.
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d. Be safeguarded from adjustments that would invalidate the
>- measurement result.
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e. Be protected from damage and deterioration during handling,
maintenance, and storage.
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In addition, the Organization shall assess and record the validity of the previous
0 -,5,7! measuring result when the equipment is found not to conform to requirements.
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0 a product affected. Records of the results of calibration and verification shall be
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When used in the monitoring and measurement of specified requirements, the
ability of computer software to satisfy the intended application shall be confirmed.
(r)
This shall be undertaken prior to initial use and reconfirmed as necessary.
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Note; Conformation of the ability of computer software to satisfy the intended
application would Typically include its verification and configuration management
to maintain its suitability for use.
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7.6.1 Measurement System Analysis |
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Statistical studies shall be conducted h) analyze the variation present in the !
results cf each type mf measuring and test equipment system, This requirement
uhaUappiytomeaaurmmantsystarnorefenanmad )ntheoontro| p|on. The
analytical methods and acceptance criteria used shall conform h0 those in
customer reference manuals on measurement systems analysis. Other analytical
� methods and acceptance criteria may be used if approved by the customer,
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7.0.2 Cali bratmnlVwhficatimoof Records
� 0 Records of the calibration/verification activity for all gauges, measuring and test '
� equipment, needed to provide evidence of conformity of product to determined !
4» o requirements, including employee and customer owned equipment shall include:
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°- � Equipment identification, including the nnemounarnen1 standard
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'> against which the equipment is calibrated.
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b. Revision following engineering changes. `
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caiibrmtion/Verification.
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�� == e� Statements of conformity to specification after calibration
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^� [ Notification bJ the customer if suspect product or material has |
.C: been shipped.
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7.8.3 Laboratory Requirements
C 7.6.3.1 Internal Laboratory
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The (]rganizutiun'e internal laboratory foci|it shall have a defined scope that \
includes its capability to perform the required |nspe(tion. Vaut or calibration |
%~ services. This laboratory scope shall be included in the quality management
system dVuunnentadon. The laboratory mhaU $pecih/ �ndimp)�nn�n�` mma !
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� minimum, t8�h�i��| requirements
o. Adequacy Qf the laboratory procedures. �
- b. Competency 0f the laboratory personnel.
C. Testing of the product, �
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Document No.: C-4.2.2-000 _ Title: Quality Manual
d. Capability to perform these services correctly, traceab e to the
relevant process standard.
e. Review of related records.
a)
7.6.3.2 External Laboratory
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External/commercial/independent laboratory facilities used for inspection test or
ai calibration services by the Organization shall have a defined laboratory scope
(.4 that includes the capability to perform the required inspection, test or calibration
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2 and there shall be evidence that external laboratory is acceptable to the
customer. Or the laboratory shall be accredited to ISO/IEC 17025 or national
a) a equivalent.
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a) 8.0 Measurement, Analysis, and Improvement.
*-'c 8.1 General.
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E The Organization shall plan and implement the monitoring, measurement,
. analysis, and improvement processes needed:
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w a. Demonstrate conformity to product requirements..
b. Ensure conformity of the Quality Management System.
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c. Continually improve the effectiveness of the Quality Management
a. a)
System.
,c d. Include determination of applicable methods, including statistical
techniques, and the extent of their use.
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O —2- This shall include determination of applicable methods, including statistical
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(,) 8.1.1 Identification of Statistical Tools
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Appropriate statistical tools for each process shall be determined during advance
quality planning and included in the control plan.
8.1.2 Knowledge of Basic Statistical Concepts
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Basic statistical concepts, such as variation, control, process capability and over-
adjustment shall be understood and utilized throughout Safariland.
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8.2 Monitoringand K0mm�ureno�nt |
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8.2.1 Customer Satisfaction.
/\a one of the measurements of the performance of the Quality Management |
System, the Organization shall monitor |rfunnetmn ra|mUn0 no customer
perception as to whether the Organization has met customer requirements. The
� methods for obtaining and using this information shall be determined and
implemented. |
Nute�. Monitoring customer perception can include obtaining input from sources
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such as customer satisfaction surveys , customer data on delivered product
quality . user opinion surveys, lost business ano|yoim, compliments, warranty
o) cz claims and dealer reports.
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y� c 8.2.1,1 Customer Satisfaction-Supplemental
�w E Customer satisfaction with the Organization shall be monitored through continual |
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' 1� eva(uabonofpe�orrnenoeuf the nea|bcaUonprocesses. Pe�orrnaAceindicators
oha|\ �ebaa�donubi��dvod�t� andi�dude. bu� �C� |ir�1��dto^
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&. Delivered part quality performance.
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b. Customer disruptions including field returns. �
C. Delivery schedule performance including pnarniunn freight .
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d. Customer notifications related ho quality or delivery issues.
The Organization shall monitor the performance of manufacturing processes to
� demonstrate compliance with customer requirements for product quality and
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efficiency of the process.
8.2.2 Internal Audit.
The Organization shall conduct internal audits at planned intervals hodetermine
whether the C>Um|ity Management System:
Conforms to the planned o[nangenTeAts, to the requirements of ISO Quality
� W1ona0annent Syo¢annR�quin»rnentmorcuetornaropeoiMuM*qUir$nnanba and im
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effectively implemented and maintained. The selection of auditors and conduct of /
audits shall ensure objectivity and impartiality of the audit process
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/\documented procedure shall bg established todefine responsibilitiesand |
requirements for planning and conducting audits, establishing records and '
reporting results.
When planned results are not achieved, correction and corrective action shall be |
taken moappropriate.
0 The responsibilities and requirements for planning and conducting audits, and for
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reporting results and maintaining naoond$ shall be defined in odocunnentmd
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procedure. !
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Records of the audits and their results shall be maintained. (See 4.2.4)
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m � The management responsible for the area being audited shall ensure that any
-- � necessary corrections and corrective actions are taken without undue delay to
' q= eliminate ina� detected nunoonh»rrnibea and their cause, Follow-up activities shall /
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include the verification of the actions taken and the reporting of verification
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8.2'2'1 Quality Management System Audit
ci"` The Organization D quality onmh� �udiCit� qua|i� aoaQernent system Uover|f« conop||anue
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with |SCv78 10949 and any additional quality management systems requirement. /
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The Organization shall audit each manufacturing process 1u determine its
� effectiveness.
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`» 8.22.3Pmmduct Audit /
C The Organization shall audit products st appropriate stages of production and
u delivery toVedfvconformnitytoaUopedY|edraguinenoents. such amproduct |
d|rnen-iuDs. functionality, packaging and labeling, at a defined frequency. |
0.2.2.4intermml Audit Plans
:3 Internal audits shall cover all quality management related processes, activities /
and shifts, and shall ba scheduled according tOan annual plan.
� When interna|/axterna| DoOcoDfurmUUesor customer complaints Vccur the' |
frequency shall be appropriately increased, Specific checklists should he used for /
each audit aa part of the audit process.
O.2.2-5 Internal Auditor Qualifications |
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Document No.: C-4.2.2-000 Title: Quality Manual
The Organization shall have internal auditors who are qualified to audit the
requirements of ISO/TS 16949 and customer specific requirements.
8.2.3 Monitoring and Measurement of Processes.
a)
The Organization shall apply suitable methods for monitoring and, where
applicable, measurement of the Quality Management System processes. These
-C3 methods shall demonstrate the ability of the processes to achieve planned
results. When planned results are not achieved, correction and corrective action
v) 4- shall be taken, as appropriate, to ensure conformity of the product.
42 at Note: When determining suitable methods, it is advisable that the organization
a) a consider the type and extent of monitoring or measurement appropriate to each
_fa 173
c 1- of it processes in relation to their impact on the conformity to product
o requirements and on the effectiveness of the quality management system
8.2.3.1 Monitoring and Measurement of Manufacturing Processes
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• E The Organization shall perform process studies on all new manufacturing
[including assembly or sequencing] processes to verify process capability and to
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tu provide additional input for process control. The results of process studies shall
• LJJ be documented with specifications, where applicable, for means of production,
measurement and test, and maintenance instructions. These documents shall
include objectives for manufacturing process capability, reliability, maintainability
and availability, as well as acceptance criteria.
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a.) The Organization shall maintain manufacturing process capability or performance
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E as specified by the customer part approval process requirements. The
Organization shall ensure that the control plan and process flow diagram are
implemented, including adherence to the specified:
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O 15 t a. Measurement techniques.
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• 0 c. Acceptance criteria.
d. Reaction plans when acceptance criteria are not met.
Significant process events, such as tool change or machine repair, shall be
recorded.
The Organization shall initiate a reaction plan from the control plan for
characteristics that are either not statistically capable or are unstable. These
reaction plans shall include containment of product and 100% inspection as
appropriate. A corrective action plan shall then be completed by the
Organization, indicating specific timing and assigned responsibility to assure that
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, Document No.: C-4.2.2-000 Title: Quality Manual
the process becomes stable and capable. The plans shall be reviewed with and
approved by the customer when so required.
The Organization shall maintain records of effective dates of process changes.
8.2.4 Monitoring and Measurement of Product.
The Organization shall monitor and measure the characteristics of the product to
verify that product requirements have been met. This shall be carried out at
appropriate stages of the product realization process in accordance with the
cr) planned arrangements.
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42 cu Evidence of conformity with the acceptance criteria shall be maintained. Records
(1) .2 shall indicate the person authorizing release of product.
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a) The release of product and sorstico delivery of service to the Customer shall not
-c proceed until the planned arrangements have been satisfactorily completed,
T. c unless otherwise approved by a relevant authority and, where applicable, by the
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When selecting product parameters to monitor compliance to specified internal
412 and external requirements, the Organization determines the types of product
c characteristics, leading to:
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0) _c a. Types of measurements.
b. Suitable measurement means.
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0 La c. The capability and skills required.
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LLI 8.2.4.1 Layout Inspection and Functional Testing
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A layout inspection and a functional verification to applicable customer
engineering material and performance standards shall be performed for each
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product as specified in the control plans. Results shall be available for customer
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a review.
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4c• 43 Note: Layout inspections is the complete measurement of all product dimensions
shown on the design records.
8.2.4.2 Appearance Items
For the Organization's manufacturing parts designated by the customer as
"appearance items", the Organization shall provide:
a. Appropriate resources including lighting for evaluation.
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Document No.: C-4.2.2-000 Title: Qualit Manual
b. Master for color, grain, gloss, metallic brilliance, texture,
distinctness of image, as appropriate.
4E" c. Maintenance and control of appearance masters and evaluation
(1)
equipment.
d. Verification the Teammates making appearance evaluations are
competent and qualified to do so.
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.4-- 8.3 Control of Nonconforming Product.
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o The Organization shall ensure that product which does not conform to product
(1) 0 requirements is identified and controlled to prevent unintended use or delivery. A
documented procedure shall be establish to define the controls and related
o responsibilities and authorities for dealing with nonconforming product sAalkiae
'> defined-in-a-doeumentee-preeedure,
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— o Where applicable the Organization shall deal with nonconforming product by
E one or more of the following ways:
0 r) a. By taking action to eliminate the detected nonconformity.
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0.. b. By authorizing its use, release or acceptance under concession by
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o a relevant authority and,where applicable, by the customer.
c. By taking action to preclude its original intended use c
O rj application.
.c d. When nonconforming product is detected after delivery or use has
started, the organization shall take action appropriate to the
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,.„I effects, or potential effects, of the nonconformity.
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• 0 When nonconforming product is corrected it shall be subject to re-verification to
ij demonstrate conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions
taken, including concessions obtained, shall be maintained
8.3.1 Control of Nonconforming Product-Supplemental
Product with unidentified or suspect status shall be classified as nonconforming
product.
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Document No.: C-4.2.2-000 Title: Quality Manual
8.3.2 Control of Reworked Product
Instructions for rework, including re-inspection requirements, shall be accessible
to and utilized by the appropriate Teammates.
8.3.3 Customer Information
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Customers shall be informed promptly in the event that nonconforming product
cn has been shipped.
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8.3.4 Customer Waiver
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O „ The Organization shall obtain a customer concession or deviation prior to further
46 a processing whenever the product or manufacturing process is different from that
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c which is currently approved.
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The Organization shall maintain a record of the expiration date or quantity
c authorized. The Organization shall also ensure compliance with the original or
‘4' °
•,_ superseding specifications and requirements when the authorization expires.
E Material shipped on an authorization shall be properly identified on each shipping
• (x)
+05 container.
This applies equally to purchased product. The Organization shall agree with any
requests from suppliers before submission to the customer.
8.4 Analysis of Data.
The Organization shall determine, collect and analyze appropriate data to
O. 12 demonstrate the suitability and effectiveness of the Quality Management System
0
and to evaluate where continual improvement of effectiveness of the Quality
.c•-: Management System can be made. This shall include data generated as a result
u.1 of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to:
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(P a. Customer satisfaction. (see 8.2.1)
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O• 0 b. Conformity to product requirements. (See 8.2.4)
c. Characteristics and trends of processes and products including
opportunities for preventive action. (see 8.2.3 and 8.2.4)
(I)
d. Suppliers. (see 7.4)
(s)
8.4.1 Analysis and Use of Data
Trends in quality and operational performance shall be compared with progress
toward objectives and lead to action to support the following:
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Document No.: C-4.2.2-000 Title: Quality Manual
a, Development of priorities for prompt solution to customer-related
problems.
b. Determination of key customer-related trends and cor-elation for
status review, decision-making and longer term plann g.
a)
c. An information system for the timely reporting of product
information arising from usage.
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lc Data should be compared with those of competitors and/or appropriate
0,) benchmarks.
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o 8.5 Improvement.
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c t5. 8.5.1 Continual Improvement
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> The Organization shall continually improve the effectiveness of the Quality
c Management System through the use of the quality policy, quality objectives,
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audit results, analysis of data, corrective and preventive action and management
review.
a) p 8.5.1.1 Continual Improvement of the Organization
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o. The Organization shall define a process for continual improvement.
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8.5.1.2 Manufacturing Process Improvement
Manufacturing process improvement shall continually focus upon control and
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reduction of variation in product characteristics and manufacturing process
c„) parameters.
w Controlled characteristics are documented in the control plan.
Te2 Continual improvement is implemented once manufacturing processes are
EI:
1— 0 capable and stable, or product characteristics are predictable and meet customer
• o requirements.
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Z 0 8.5.2 Corrective Action.
The Organization shall take action to eliminate the cause of nonconformities in
order to prevent recurrence. Corrective actions shall be appropriate to the effects
of nonconformities encountered.
(i)
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A documented procedure shall be established to define requirements for:
a. Reviewing nonconformities including customer complaints.
b. Determining the causes of nonconformities.
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Document No.: C-4.2.2-000 Title: Quality Manual
c. Evaluating the need for action to ensure that nonconformities do
not recur.
4E' d. Determining and implementing action needed.
e. .
Records the results of action taken (see 4.2.4)and
f. Reviewing the effectiveness of preventive action taken.
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8.5.2.1 Problem Solving
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w 0 cause identification and elimination.
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If a customer-prescribed problem-solving format exists, the Organization shall
5 -c use the prescribed format.
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• 0 8.5.2.2 Error Proofing
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The Organization shall use error-proofing methods in their corrective action plans.
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1.1.1 8.5.2.3 Corrective Action Impact
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(I) - The Organization shall apply to other similar processes and products the
corrective action, and controls implemented, to eliminate the cause of
›- nonconformity.
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0 8.5.2.4 Rejected Product Test/Analysis
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11.1 The Organization shall analyze parts rejected by the customer's manufacturing
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plants, engineering facilities, and dealerships. The Organization shall minimize
the cycle time of this process. Records of these analyses shall be kept and made
it— 0 available upon request. The Organization shall perform analysis and initiate
(,) corrective action to prevent recurrence.
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_75 0 Cycle time related to rejected product analysis should be consistent with the
determination of root cause, corrective and monitoring the effectiveness of
implementation.
8.5.3 Preventive Action
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The Organization shall determine action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions shall be
appropriate to the effects of the potential problems.
A documented procedure shall be established to define requirements for:
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Document No.: C-4,2.2-000 Title: Quality Manual
a. Determining potential nonconformities and their causes.
b. Evaluating the need for action to prevent occurrence of
nonconformities.
c. Determining and implementing action needed.
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(PI d. Record of results of action taken. (see 4.2.4) and
e. Reviewing the effectiveness of the preventive action taken.
e 23
RECORDS, REPORTS, AND FORMS
4.)
c In Shall be developed as required to support compliance to the Quality Management
System Requirements.
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o REFERENCES
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ISO 9001:2008[E]
0 ISO/TS 16949:2002 9[E]
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Any Customer Specific Requirements
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