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DOCUMENT NUMBER: 99-9999 PAGE 1 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
EV CN #: DESCRIPTION:
08 CAT-98-2251 Renew spec without content changes – <Name> – 10/12/98 (rm)
09 CAT -99-0275 Complete rewrite, reformat to comply with governing spec
7-section formatting – <Name> – 2/5/99 – (rm)
10 CAT -99-0596 CN – To comply with ISO audit finding in development of a more robust
and closed loop system for dealing with out-of-tolerance and overdue
measurement and test equipment that require calibration from the site(s)
Standard Calibration Lab – <Name> – 4/2/99 (rm)
11 CAT -99-0920 CN – Clarify when a DRB should not occur – <Name> – 5/26/99 – (ks)
12 CAT -00-0162 CN – Rewrite by <Name> – 02/14/00 – (ks)
13 Draft Complete rewrite using new template to comply with ISO 9001:2000 –
(ks)
DISTRIBUTION AND QUANTITY: “B” LOOP
C-DMIS 1
Trng Pod 1
APPROVALS: ISSUE DATE:
SPEC OWNER: <Name> * REVIEW CYCLE: Annual
QUALITY SYSTEMS MANAGER: <Name> * EXPIRATION DATE:
<BUSINESS UNIT> TRAINING: <Name> * GROUP RESPONSIBLE: Quality Systems
Department
*Signatures/Master on File in <Business Unit> DMIS
TITLE: <Business Unit> Quality Manual
DOCUMENT NUMBER: 99-9999 PAGE 2 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
Table of Contents
1 Purpose............................................................................................................................. 5
2 Scope................................................................................................................................ 5
3 Applicable Documents ...................................................................................................... 5
4 General ............................................................................................................................. 6
4.1 Definitions................................................................................................................. 6
4.2 <Business Unit> Profile ............................................................................................ 7
4.2.1 <Business Unit> history................................................................................ 7
4.2.2 <Business Unit> vision ................................................................................. 8
4.2.3 <Business Unit> mission statement ............................................................. 8
4.2.4 <Business Unit> values................................................................................ 8
4.3 Quality Management System Documentation........................................................... 9
4.3.1 <Business Unit> quality management system.............................................. 9
4.3.2 <Business Unit> documentation and documentation levels ......................... 9
4.3.3 Quality records ........................................................................................... 10
4.4 Quality Manual........................................................................................................ 10
4.4.1 Classification and control............................................................................ 10
4.4.2 Distribution ................................................................................................. 10
4.4.3 Review and revision ................................................................................... 11
4.4.4 Approval ..................................................................................................... 11
4.5 Control of Documents............................................................................................. 11
4.6 Control of Quality Records...................................................................................... 12
5 Management Responsibility ............................................................................................ 13
5.1 Management Commitment ..................................................................................... 13
5.2 Customer Focus ..................................................................................................... 13
5.3 Quality Policy.......................................................................................................... 14
5.3.1 <Business Unit> quality policy.................................................................... 14
5.3.2 <Company> mission and quality value statements .................................... 14
5.3.3 Communicating the <Business Unit> quality management system to
employees ............................................................................................................. 14
5.4 Planning.................................................................................................................. 14
5.4.1 Quality objectives ....................................................................................... 14
5.4.2 Quality management system planning ....................................................... 15
5.5 Responsibility, Authority, and Communication........................................................ 15
5.5.1 <Business Unit> quality management structure ......................................... 15
5.5.2 Deployment responsibilities of management.............................................. 16
5.5.3 Personnel responsible for quality implementation ...................................... 18
5.6 Management Review.............................................................................................. 18
5.6.1 Frequency .................................................................................................. 18
5.6.2 Review items.............................................................................................. 19
5.6.3 Review outcome......................................................................................... 19
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
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6 Resource Management................................................................................................... 19
6.1 Assignment of Personnel........................................................................................ 19
6.2 Competence, Awareness, and Training.................................................................. 20
6.2.1 Commitment to training .............................................................................. 20
6.2.2 Identifying competency needs and developing training schedules............. 20
6.2.3 Technical training and evaluation............................................................... 20
6.2.4 Training records ......................................................................................... 21
6.3 Infrastructure .......................................................................................................... 21
6.4 Work Environment.................................................................................................. 21
7 Product Realization......................................................................................................... 22
7.1 Planning of Product Realization.............................................................................. 23
7.1.1 Creating product-specific quality plans....................................................... 23
7.1.2 Quality plan documentation........................................................................ 23
7.2 Customer-Related Processes................................................................................. 24
7.2.1 Determination of requirements related to deliverables ............................... 24
7.2.2 Review of requirements related to deliverables.......................................... 24
7.2.3 Customer communication........................................................................... 25
7.3 Design and Development ....................................................................................... 25
7.3.1 Design and development planning ............................................................. 25
7.3.2 Design and development inputs ................................................................. 25
7.3.3 Design and development outputs............................................................... 26
7.3.4 Design and development review ................................................................ 26
7.3.5 Design and development verification.......................................................... 26
7.3.6 Design and development validation............................................................ 27
7.3.7 Control of design and development changes ............................................. 27
7.4 Purchasing.............................................................................................................. 27
7.4.1 Purchasing process.................................................................................... 27
7.4.2 Purchasing information............................................................................... 28
7.4.3 Verification of purchased product............................................................... 28
7.5 Production Provision............................................................................................... 29
7.5.1 Control of production operations ................................................................ 29
7.5.2 Validation of processes for production ....................................................... 30
7.5.3 Identification and traceability ...................................................................... 31
7.5.4 Customer property...................................................................................... 32
7.5.5 Preservation of product .............................................................................. 32
7.6 Control of Monitoring and Measuring Devices........................................................ 32
7.6.1 Introduction................................................................................................. 32
7.6.2 Calibration safeguards, identification, status, and records ......................... 33
7.6.3 Calibration methods ................................................................................... 33
7.6.4 Corrective action ........................................................................................ 33
8 Measurement, Analysis, and Improvement ..................................................................... 34
8.1 Planning Monitoring, Measurement, and Improvement Activities ........................... 34
8.2 Monitoring and Measurement................................................................................. 35
8.2.1 Customer satisfaction................................................................................. 35
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
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8.2.2 Internal and external audits ........................................................................ 35
8.2.3 Monitoring and measurement of processes................................................ 36
8.2.4 Monitoring and measurement of deliverables............................................. 36
8.3 Control of Nonconforming Product ......................................................................... 37
8.3.1 Disposition Review Board........................................................................... 37
8.3.2 Material Review Board ............................................................................... 37
8.4 Analysis of Data...................................................................................................... 37
8.5 Improvement........................................................................................................... 37
8.5.1 Continual improvement .............................................................................. 37
8.5.2 Corrective and preventive actions .............................................................. 37
8.5.3 Customer feedback system........................................................................ 38
8.5.4 Corrective action tracking........................................................................... 38
8.5.5 Corrective/preventive action implementation.............................................. 38
8.5.6 Corrective/preventive action escalation...................................................... 38
9 Revision History .............................................................................................................. 39
10 Appendices .....................................................................................................................40
10.1 Key Organizational Responsibilities ....................................................................... 40
10.2 ISO 9001:2000/<Business Unit> Quality Manual Matrix......................................... 43
10.3 <Business Unit> Quality Manual/Quality Management System Documentation
Matrix...................................................................................................................... 46
10.4 Abbreviations.......................................................................................................... 50
DOCUMENT NUMBER: 99-9999 PAGE 5 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
<Business Unit>
Quality Manual
1 Purpose
The <Business Unit> Quality Manual serves several purposes. The manual:
• Establishes a concise outline of <Business Unit>’s quality management system, including the
strategies for achieving and maintaining quality standards across all processes that comprise
<Business Unit>’s quality management system.
• Provides a reference for <Business Unit>’s quality management system procedural
documentation and work instructions.
• Identifies and designates the responsibility and authority for implementing and maintaining
<Business Unit>’s quality management system.
• Establishes and demonstrates compliance of <Business Unit>’s quality management system
with the International Organization of Standardization (ISO) 9001:2000 standard.
2 Scope
This document applies to <Business Unit>. It complies with all requirements of ISO 9001:2000
but may contain information beyond the scope of ISO 9001:2000 registration.
3 Applicable Documents
Number Title
ISO 9001:2000(E) Quality management systems – Requirements
http://legal.<Company>.
com/crm/index.htm
Corporate Records Management Document Retention
Guidelines
http://legal.<Company>.
com/crm/index.htm
Corporate Records Management Document Handling
Procedures
http://services.<Company>.
com/EHS
Various corporate Environmental Health and Safety guidelines
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
4 General
4.1 Definitions
Definitions for the terms used in this document are as follows:
Term Description
Controlled
distribution
The automatic distribution of controlled documents to controlled
locations where the documents are used. Controlled distribution
ensures that documents are distributed every time they are
modified, including revisions, renewals, and Temporary
Engineering Instructions (TEIs), or rendered obsolete.
Controlled
document
A document that:
• Meets Information Security requirements for creation, approval,
distribution, and retrieval.
• Is legible and readily identifiable.
Additionally, controlled documents may be defined by either or
both of the following criteria:
• May be used to procure or produce products.
• May have an impact on the quality of the deliverable.
Controlled
documents list
A group of indexes that list the current revision status of
controlled documents.
Customer Recipient of a deliverable resulting from <Business Unit>
processes.
Deliverable An output from a specific process expressed as a product or a
process.
Document change
control
Process by which controlled documents are reviewed and
approved by authorized personnel at initial and superseding
(revised) issues.
ISO 9001 A member of the ISO 9000 family of internationally recognized
and accepted standards, specifies requirements for a quality
management system where an organization needs to demonstrate
its ability to provide products that meet customer and applicable
regulatory requirements and aims to enhance customer
satisfaction.
Objective evidence Data obtained through observation, measurement, test, or other
empirical means that support the existence or verity of something.
Management
system
A set of interrelated or interacting elements for establishing policy
and objectives and for achieving those objectives.
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
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Term Description
Quality The degree to which a set of inherent characteristics of a product,
process, or system, to fulfill requirements of the organization, its
customers, and other interested parties.
Quality
management
Coordinated activities for directing and controlling an
organization with regard to quality.
Quality
management system
A management system for directing and controlling an
organization with regard to quality. Direction and control
generally include establishment of the quality policy and quality
objectives, quality planning, quality control, quality assurance,
and quality improvement.
Quality manual Document specifying the quality management system of an
organization.
Quality objective Something sought, or aimed for, related to quality.
Quality plan Documentation specifying which procedures and associated
resources are to be applied by whom and when to a specific
project, product, process, or contract.
Quality policy An organization’s overall business commitments toward quality
systems, continual improvement, and customer satisfaction as
formally expressed by top management.
Quality record Documentation that:
• States results achieved or provides objective evidence of
activities performed in fulfillment of quality requirements.
• Is identified by name (as a quality record) in the appropriate
controlled document.
Quality system The organizational structure, responsibilities, procedures,
processes, and resources needed to implement quality
management (refer to previous term, Quality management).
4.2 <Business Unit> Profile
4.2.1 <Business Unit> history
<Business Unit> is a business unit within <Company>’s <Sector>. <Business
Unit>was established in 1992 and merged with <another business unit> in 1998.
The <Business Unit>facility includes over 120,000 square feet of manufacturing
space, operates 24 hours a day, 7 days a week, and employs approximately 900
full-time employees.
As a design, development, and deployment facility of new assembly test
technologies, <Business Unit>produces microprocessor and semiconductor
products for the worldwide market. The factory is dedicated to the introduction of
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
new assembly technologies prior to their being transferred to <Company> high-
volume manufacturing (HVM) sites.
<Business Unit> does not provide direct servicing to its customers, and this is
reflected in the reduced scope of <Business Unit>’s ISO 9001:2000-compliant
quality management system and quality manual. Likewise, owing to the nature of
its processes, non-CPU (Central Processing Unit) activities and concept
qualification (Path Finding) activities fall outside the scope of this quality manual.
4.2.2 <Business Unit> vision
Interconnecting silicon to the digital world.
4.2.3 <Business Unit> mission statement
Identify, develop, and deliver assembly packaging solutions to meet <Company>’s
business needs.
4.2.4 <Business Unit> values
<Business Unit>is guided by the following values:
• Uncompromised integrity and honesty. We trust each other, employ
<Company>’s Code of Conduct, and disclose issues and risks fully.
• Assume ownership. We own the problem and drive resolution, and we find
the right people to get it resolved.
• Speak with data. We support our conclusions with data.
• Be disciplined. We hold effective meetings, are on time, and employ
systematic problem-solving methodology.
• Open communication. We explain what we know when we know it.
• Make and meet commitments. We base business goals on high-confidence
schedules, identify stretch goals to challenge ourselves, and do everything
within reason to meet those schedules.
• Teamwork. We contribute ideas to result in more options and better problem
resolution, we reallocate resources to maximize organization results, and we
work as one organization and to one agenda for the common good.
• Safety. Safety is owned by everyone. We proactively promote a safe and
healthy environment.
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
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4.3 Quality Management System Documentation
4.3.1 <Business Unit> quality management system
This manual defines the <Business Unit>quality management system. The quality
management system consists of <Business Unit>’s quality manual, procedural
documentation and work instructions, quality objectives and quality plans,
activities, practices, resources, and quality records which together ensure that
<Business Unit>’s deliverables conform to the requirements of the organization, its
customers, and other interested parties.
4.3.2 <Business Unit> documentation and documentation levels
The <Business Unit>quality management system is documented in sufficient detail
to ensure its effective operation and control of processes. Procedural coverage
varies depending on the type of activity, the complexity of processes and their
interactions, and on the competence of personnel involved in carrying out the
activity.
The following table shows how <Business Unit>’s quality management system is
documented. Each level of documentation contains steadily increasing details about
<Business Unit>’s quality operations and methods. Documents that direct activity
affecting <Business Unit>’s quality management system are placed under control.
Level Documentation Type Describes . . .
1 <Business Unit> Quality
Manual
<Business Unit>’s quality management
system: its scope, the interaction between
the processes of the quality management
system, and the documented procedures
established for the effective operation of
that system.
2 Procedural
documentation
Responsibilities and governing procedures
within the <Business Unit> quality system.
Samples include the following types of
documents:
• <Business Unit> operating policies and
procedures
• Functional group governing procedures,
process specifications, and business
flow diagrams
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
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Level Documentation Type Describes . . .
3 Work instructions Steps to be taken within a specific job
function to achieve quality and production
plan results. Samples include the following
types of documents:
• Process operational specifications
• Preventive maintenance specifications
• Local desktop procedures (LDCs)
• Best known methods (BKMs)
• Toolkits
4.3.3 Quality records
<Business Unit> maintains quality records at each documentation level to
demonstrate:
• Conformity to specified requirements.
• Suitability, adequacy, and effective operation of the quality management
system.
4.4 Quality Manual
4.4.1 Classification and control
<Business Unit>’s quality manual is classified as <Company> Confidential and is a
controlled document. Control is exercised by Document Management Information
Services (DMIS).
4.4.2 Distribution
DMIS distributes controlled copies of the current revision of <Business Unit>’s
quality manual to individuals and departments on request.
Uncontrolled copies of <Business Unit>’s quality manual can be viewed and
printed by accessing the following online resources:
• Documentum (WorkSpace, SmartSpace, Vspec)
• The <Business Unit> DMIS shared local repository
Copies printed using these access modes are uncontrolled reference copies.
Individuals with uncontrolled copies must take responsibility for verifying that they
are in possession of the current revision of this quality manual. They do this by
contacting DMIS directly or by checking the controlled documents list on the
<Business Unit> DMIS shared local repository or on the DMIS shared repository on
the <Company> intranet.
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
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4.4.3 Review and revision
<Business Unit> employees are encouraged to propose amendments, additions, and
improvements to this quality manual through their supervisor or manager or
directly to the Quality Systems Manager.
Maintenance and revision of <Business Unit>’s quality manual are the
responsibility of the <Business Unit> Quality Systems Manager. The manual is
reviewed at a minimum on an annual basis and as necessary to incorporate changes
in business direction and continual improvement activities.
4.4.4 Approval
The <Business Unit> ISO Management Representative approves the release of
<Business Unit>’s quality manual. Other approvals may be required at the
discretion of designated <Business Unit> management staff. Records of the review
and approval processes are maintained.
4.5 Control of Documents
<Business Unit> places documents that direct activity affecting its quality management
system under strict approval, controlled distribution, and change control, including to the
extent applicable documents of external origin such as standards and customer documents.
Authorized personnel review and approve controlled documents for adequacy prior to issue,
and a quality record is kept of this process. When changes are required to existing
documents, designated functions are provided with pertinent information, including
recommended improvements and corrective or preventive action implementation, upon
which to base their review and approval. The nature of the change and the current revision
status are identified in the controlled document.
After approval, the relevant version of the document is distributed under controlled
conditions to all locations where operations essential to the effective functioning of the
quality system are performed. Locations may be authorized distribution points, electronic
terminals, or a central or local repository. Members of the affected work group receive
relevant training when systems, processes, or procedures are implemented or modified.
<Business Unit> promptly removes obsolete (not current) controlled documents from all
points of issue or use or otherwise assures against their unintended use. Obsolete controlled
documents retained for legal and/or knowledge-preservation purposes are suitably
identified.
<Business Unit> uses several methods to maintain the current revision status of all
<Business Unit> controlled documents. To preclude anyone’s using obsolete documents,
DMIS maintains a controlled documents list that is readily accessible to users of the
<Business Unit> DMIS shared local repository and the DMIS shared repository located on
<Company>’s intranet. In addition, designated personnel who use non-DMIS controlled
documents maintain records of the current revision status of their documents; for example,
local desktop procedures, best known methods, and toolkits.
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
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4.6 Control of Quality Records
<Business Unit> maintains quality records to provide evidence of conformity to specified
requirements and of the effective operation of the quality management system. Pertinent
quality records from subcontractors are elements of these data.
In accordance with <Company> guidelines and procedures, <Business Unit> maintains
quality records that:
• Are legible and readily identifiable to the product/process involved.
• Are retrievable.
• Are protected against deterioration, damage, and loss.
• Have established retention periods.
Retention periods vary from record to record depending on statute or regulation, trade
practices, projected business needs, or specific customer requirements. For longer storage
periods, quality records are stored off-site.
Each functional work group maintains a master index that identifies records that support
and substantiate all <Business Unit> quality-related activities. The index specifies, as a
minimum, the following:
• Name of quality record
• Medium (paper, foils, microfilm, magnetic disk or tape, optical disk, photograph, or a
combination thereof)
• Responsible group ensuring the integrity of the quality record
• Location where the quality record is maintained
• Retention period
• Disposition authority for the quality record
5 Management Responsibility
5.1 Management Commitment
<Business Unit> management staff is committed to the development, implementation, and
improvement of <Business Unit>’s quality management system. The quality management
system rests on the following foundations:
• <Business Unit> management staff communicates to employees the importance of the
quality management system to the continued success and effectiveness of the
organization.
• <Business Unit> management staff and personnel are visibly and actively committed to
a total quality system and to its continual improvement.
• <Business Unit> management staff continually assesses the quality management
system’s capability to fulfill customer requirements and expectations.
• <Business Unit> management staff ensures planning and allocation of necessary
resources, including the assignment of competent personnel.
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<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
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• <Business Unit> management staff defines responsibilities for personnel who perform
work and verify activities affecting quality.
• Documented and controlled processes are implemented and maintained.
• An effective corrective and preventive action program is implemented and maintained.
5.2 Customer Focus
<Business Unit> management staff, with help from other <Company> management teams,
ensures that customer requirements (i.e., needs and expectations) are determined, converted
into specific requirements related to the deliverable, and fulfilled with the goal of enhancing
customer satisfaction. Methods used may include:
• Identifying potential customers
• Customer surveys
• Customer feedback
• Customer requests for product changes
• Market research
• Analysis of competitive products
• Benchmarking
5.3 Quality Policy
5.3.1 <Business Unit> quality policy
<Business Unit> is committed to continuous quality improvement of our products,
processes, and people. Quality is integrated into all aspects of our business and
forms the foundation of customer satisfaction.
5.3.2 <Company> mission and quality value statements
<Business Unit>’s quality policy is the driver for the quality system. It is linked to
<Business Unit>’s vision, mission, and values. Together they support
<Company>’s mission statement:
Do a great job for our customers, employees and stockholders by being the
preeminent building block supplier to the worldwide Internet economy.
<Business Unit>’s quality policy, vision, mission, and values are aligned with
<Company>’s value statement on quality:
We strive to:
• Achieve the highest standards of excellence
• Do the right things right
• Continuously learn, develop and improve
• Take pride in our work
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5.3.3 Communicating the <Business Unit> quality management system to
employees
<Business Unit>’s quality policy, vision, mission, and values, as well as
<Company>’s mission and quality value, are communicated throughout the
organization by:
• Key personnel who are responsible for implementing <Business Unit>’s quality
management system.
• Using various media, including distribution of controlled documents, the
<Business Unit> newsletter, bulletin board postings, badge cards, monthly
update meetings (MUMs), quality-related training, team briefings, and the
<Company> intranet.
5.4 Planning
5.4.1 Quality objectives
<Business Unit> management staff establishes measurable quality objectives and
related requirements that are consistent with <Business Unit>’s quality policy and
communicates them to relevant functions and levels within the organization using,
among other instruments:
• <Business Unit> Agenda. The annual <Business Unit> Agenda lists
objectives pertaining to the general quality system and continual improvement.
• Management by Planning (MBP). MBP objectives include objectives for
increasing organizational effectiveness, productivity, and employee satisfaction.
Other quality objectives include those for product and improving products and
processes. Together, these quality objectives drive the quality management system
planning process.
5.4.2 Quality management system planning
<Business Unit> management staff identifies and plans processes and resources
required for the quality system and for achieving quality objectives. Elements in the
overall quality management system planning process include:
• Planning for the achievement of quality objectives and general quality system
planning, the results of which are manifested in <Business Unit>’s quality
manual.
• Planning of product realization processes and product verification and
validation activities.
• Design and development planning.
• Planning of monitoring and measurement of products, capability of processes,
achievement of project objectives, and customer satisfaction.
• Planning for continual improvement.
Quality planning also ensures that adequate and appropriate resources are identified
and implemented throughout the organization.
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The output of the quality management system planning process is documented in
quality records. Any changes that are introduced into the quality management
system are conducted in a controlled manner in order to maintain the integrity of
the system.
5.5 Responsibility, Authority, and Communication
5.5.1 <Business Unit> quality management structure
<Business Unit> management staff is responsible for defining, implementing, and
maintaining the <Business Unit> quality system. This responsibility is delegated
through the organization using structured lines of authority (see organizational
chart). The structure:
• Integrates all activities that affect the quality of <Business Unit> processes and
products into a single system.
• Facilitates reliable and continuous control over those activities.
• Ensures that appropriate communication processes are established and that
communication takes place regarding the effectiveness of the quality
management system.
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Important: Departments identified in shaded boxes fall outside the scope of
<Business Unit>’s ISO registration. Departments connecting to the <Business
Unit> organization using dashed lines are outside <Business Unit> but provide
support functions.
Finance
Director, <Business Unit>
Organizational
Effectiveness
Programs (OEP)
Assembly Technology
Architecture and
Pathfinding
Module Engineering Factory Operations
Roadmap and
Business Process
Management (RBPM)
Platform, Materials,
and Enabling
Development (PMED)
Automation Non-CPU Packaging
Design Process
Development (DPD)
Human Resources
Quality and Reliability
(Q&R)
Quality and Reliability
Engineering Support
5.5.2 Deployment responsibilities of management
<Business Unit> management staff acknowledges its responsibility for deploying
<Business Unit>’s quality management system throughout the organization by:
• Defining and documenting <Business Unit>’s quality policy and quality
objectives, and ensuring that they are communicated and understood within the
organization.
• Appointing a management representative with authority to ensure that the
quality management system is effectively implemented and maintained.
• Establishing work roles and responsibilities.
• Regularly reviewing the status and adequacy of <Business Unit>’s quality
management system.
• Communicating to the organization the importance of meeting customer as well
as statutory and regulatory requirements.
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<Business Unit> management staff gives personnel performing quality functions
sufficient responsibility and authority to:
• Identify and record problems relating to <Business Unit>’s deliverables.
• Initiate action to prevent the occurrence of nonconformities relating to
<Business Unit>’s products, processes, and quality system.
• Initiate, recommend, or provide solutions through designated channels.
• Verify the implementation of solutions.
• Control further processing, delivery, or installation of nonconforming product
until the deficiency or the unsatisfactory condition has been corrected.
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5.5.3 Personnel responsible for quality implementation
The responsibility, authority, and interrelationship of all personnel who manage,
perform, and verify work are defined by procedures within the various departments
and functional work groups, in organizational charts, and in Appendix 10.1, Key
Organizational Responsibilities. The responsibilities for the <Business Unit>
Director and the <Business Unit> ISO Management Representative appear in the
table below.
This person . . . is responsible and accountable for . . .
<Business Unit>
Director
• Overall management of the business, including
<Business Unit>’s quality management system as
defined in <Business Unit>’s quality manual.
<Business Unit>
ISO Management
Representative
• Reviewing <Business Unit>’s quality management
system and reporting the findings to management staff.
• Maintaining the effectiveness of <Business Unit>’s
quality management system by adapting it to fit changing
circumstances.
• Ensuring that functional work groups are proactive when
probable instances of nonconformity exist.
• Reporting to <Business Unit> management staff if
resources are inadequate for maintaining an effective
internal quality audit program.
• Maintaining contact with the Registering Authority.
• Providing <Business Unit> management staff with
updates on the findings of quality audits and assessments
and with progress reports on plans for corrective action
that result from the findings of these audits and
assessments.
• Ensuring the promotion of awareness of customer
requirements throughout the organization.
• Performing the duties of a management representative as
defined in ISO 9001:2000.
5.6 Management Review
5.6.1 Frequency
<Business Unit> management staff periodically review the <Business Unit> quality
management system to ensure its continuing suitability, adequacy, and
effectiveness. The reviews assess opportunities for improvement and the need to
incorporate improvements in <Business Unit>’s quality management system,
including changing <Business Unit>’s quality policy and quality objectives. The
review occurs at least once a year but may occur more often based on the
performance of the quality management system and business needs.
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5.6.2 Review items
Review items at any one meeting vary depending on importance, frequency of
meetings, and whether the meetings are attended by <Business Unit> management
staff or by another appropriate level of management. <Business Unit> management
staff use these meetings to address, over the course of a year, the following
performance and improvement opportunities:
• Results of audits
• Customer feedback
• Process performance and product conformity
• Status of preventive and corrective action
• Follow-up actions from previous management reviews
• Planned changes that could affect the quality management system
• Recommendations for improvement
5.6.3 Review outcome
The outcome of a review includes actions related to:
• Improvement of the effectiveness of the quality management system and its
processes.
• Improvement of deliverables related to requirements.
• Resource needs.
Results of the reviews are recorded and required actions (ARs) are assigned to
responsible parties for follow-up actions. The status of ARs is tracked to ensure
successful and timely completion.
6 Resource Management
<Business Unit> determines and provides the resources needed to:
• Implement and maintain the quality management system and continually improve its
effectiveness.
• Enhance customer satisfaction.
6.1 Assignment of Personnel
Personnel performing work affecting <Business Unit> deliverables are deemed competent
on the basis of their appropriate education, skills, experience, and training. Appropriate
departments and functional work groups maintain records documenting employees’
competencies..
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6.2 Competence, Awareness, and Training
6.2.1 Commitment to training
<Business Unit> management staff is committed to employee training as a way of
ensuring that personnel:
• Have the knowledge, skills, tools, and techniques required to perform their jobs
and initiate improvements and innovations.
• Understand the potential consequences of not following procedures.
• Are aware of the relevance and importance of their activities and how they
contribute to the achievement of <Business Unit>’s quality objectives.
This commitment to training extends to newly recruited personnel and personnel
transferred to new assignments.
6.2.2 Identifying competency needs and developing training schedules
Each functional work group is responsible for:
• Determining the necessary competence for personnel performing work affecting
deliverables by analyzing job requirements and an individual’s current
qualifications and career development goals.
• Developing and regularly reviewing training plans and schedules.
• Arranging training or taking other actions to satisfy competency needs of
personnel.
• Ensuring that training or other actions continue to be appropriate throughout an
individual’s tenure in the work group.
6.2.3 Technical training and evaluation
A technical training group coordinates and facilitates the instruction of <Business
Unit> personnel who require additional technical skills as required by <Business
Unit> business and training needs. Training may occur on the job, in a formal
classroom setting, or off-site at a customer’s or supplier’s facility. The training
group regularly evaluates training activities to ensure that they are fulfilling the
requirements of personnel and the needs of <Business Unit>.
Individual functional groups also evaluate their training needs. These needs may
change because:
• An employee is reassigned, promoted, or assumes additional responsibilities.
• A new employee is hired.
• Customer requirements change.
• A new structure, system, process, or procedure is implemented.
• A specific performance problem is identified.
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6.2.4 Training records
Personnel competency needs are documented in departmental and/or individual
employee training plans. Qualified trainers and facilitators carry out the training.
Records of an individual’s training and qualifications (including copies of licenses
and certifications, as appropriate) are maintained.
6.3 Infrastructure
<Company> provides the infrastructure <Business Unit> needs to achieve conformity to
requirements for deliverables, including:
• Buildings, workspace, and associated utilities.
• Process equipment, both hardware and software.
• Supporting services, such as transport facilities and information and communication
technology.
Southwest Regional Site Materials and Services (SMS) provisions and maintains buildings,
workspace, and associated utilities. Specifically SMS:
• Installs, qualifies, operates, and maintains process support facilities.
• Monitors the performance of facilities support equipment associated with product
manufacturing.
• Provides preventive and corrective maintenance of facilities support and monitoring
equipment.
6.4 Work Environment
<Business Unit> management staff, with support from <Company> Site Environmental,
Health, and Safety (EHS), is committed to providing a suitable work environment.
The following human factors affect the work environment:
• Creative work methodologies, such as telecommuting
• Opportunities for professional and personal development through programs such as
ERSA (Employee Relations Self-Assessment)
• Opportunities for greater involvement within <Business Unit> and outside in the
community through programs such as <Company>’s It’s a Great Place to Work
• Ergonomics
• Workplace location
• Safety rules and guidance
• Use of protective equipment
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The following physical factors affect the work environment:
• Cleanliness
• Hazardous substances and situations
• Air flow, temperature, humidity, and pollution
• Lighting
• Noise and vibration
7 Product Realization
<Business Unit>’s manufacturing packaging technology development consists of five phases,
associated activities, and “Rev” (Revision) levels:
• Path Finding. Assembly and test and silicon technology optimization begins during this phase.
Silicon and packaging technology roadmaps are synchronized, and the strategic assembly
technology direction is determined. The Technology Architecture Plan (TAP) is published.
• Definition. The packaging technology envelope is defined and aligned with business and
product needs during this phase. The product is formally added to the <Business Unit>
roadmap, and the product Package Design Requirements Document (PDRD) is initiated.
Among the controlled documents that are released are the Product Division’s Package Product
Requirements Document (PRD); the initial Technology Target Specification (TTS), which
defines the requirements for a package technology; the initial design rules; and the initial
Technology Performance Specifications (TPSs).
• Discovery. The assembly and test process, materials, piece-parts, and equipment are designed
to satisfy the packaging technology envelope, lead product requirements, and design rules
during this phase. A Plan of Record (POR) baseline process is established.
• Development. The baseline process is defined. During this phase, the focus is on
manufacturing stability and capability and the analysis of data related to manufacturability,
yield, and reliability, as well as EHS (environmental, health, and safety) data related to
equipment, materials, and waste streams. Process specifications are written and change control
is implemented.
• Deployment. Revenue product begins to ship and the factory ramps to high-volume
manufacturing during this phase, which is normally defined as the period from Technical
Certification to Factory Certification or High-Volume Manufacturing (HVM) Certification.
(When Simultaneous Technical Certification [STC] methodology is employed, Technical
Certification and HVM Certification occur simultaneously.) Continual focus is on yield and
manufacturability improvements. The Development Manufacturing Line transfers the process
to the production factory.
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The following figure represents the five phases of <Business Unit>’s manufacturing packaging
technology development that are described in the preceding paragraphs. The figure also defines
the scope of <Business Unit>’s ISO 9001:2000 certification. The scope starts with the initial
publication of the Technology Target Specification and ends with High-Volume Manufacturing
Certification, when the packaging process has been duplicated in the receiving factory and the
factory assumes responsibility for running and sustaining the process.
Path-
Finding Definition Discovery Development Deployment
Technology
Target
Specification
High-Volume
Manufacturing
Certification
Technology
Certification
Plan of
Recordand
Non-
CPU Scope of ISO Certification
7.1 Planning of Product Realization
7.1.1 Creating product-specific quality plans
<Business Unit> creates product-specific quality plans for product realization
processes and for product verification and validation activities. These plans are
consistent with the other requirements of <Business Unit>’s quality management
system.
In creating product-specific quality plans, <Business Unit> determines:
• Quality objectives and requirements for the deliverable.
• The need to establish processes, documents, and provide resources specific to
the deliverable.
• Required verification, validation, monitoring, inspection, and test activities
specific to the deliverable.
• Product acceptance criteria.
• Records needed to provide evidence that the realization processes and resulting
deliverable fulfill requirements.
7.1.2 Quality plan documentation
<Business Unit> documents its plans for realization processes and for verification
and validation activities in product drawings and specifications, material or process
flow diagrams, process flowcharts, setup sheets, verification and validation reports,
work orders, lot travelers, inspection and test procedures, and similar documents
that define the manner of production and specify the inspection and test programs
for given products. Collectively, these documents comprise the product-specific
quality plan.
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7.2 Customer-Related Processes
7.2.1 Determination of requirements related to deliverables
<Business Unit> does not identify requirements initiated by external customers;
rather, a corporate organization determines them in accordance with documented
procedures. The procedures ensure that the following items are determined:
• Requirements specified by the customer, including requirements for delivery. If
customer requirements differ from standard <Company> products, a corporate
mediator resolves the differences.
• Requirements and technologies not stated by the customer but necessary for
specified use or application.
• Statutory and regulatory requirements related to the product.
• Any additional requirements determined by corporate.
These requirements are communicated to <Company> divisions, fabrication sites,
and subsequently <Business Unit>.
Requirements may also be initiated by internal customers who want to have
<Business Unit>’s processes applied to their design concepts. Design concepts are
systematically analyzed to identify customer requirements.
7.2.2 Review of requirements related to deliverables
<Business Unit> reviews requirements related to deliverables prior to the
commitment to supply deliverables to customers. The review process ensures that:
• Product and technology requirements are understood.
• Requirements differing from those previously expressed are resolved.
• Requirements are confirmed before acceptance.
• <Business Unit> can meet the defined requirements.
Review results and action items are maintained.
Requirements for deliverables are defined in terms of frequency, power, die size,
device speed, volumes, delivery dates, and other factors. They are communicated to
responsible departments and functional work groups within <Business Unit> using
various methods, including:
• Technology Target Specifications
• Module Target Specifications (MTSs)
• Design rules
• Technology Performance Specifications (TPSs)
• Equipment specifications
• Material specifications
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• Package Design Requirements Documents (PDRDs)
• Bills of Materials (BOMs)
• Plan It
• Meeting minutes
• Scientific record books
When requirements for deliverables change, <Business Unit> ensures that the
relevant documents are amended and that relevant personnel are made aware of the
changes.
7.2.3 Customer communication
<Business Unit> has implemented effective processes for communicating with its
customers. These customers may be other <Company> organizations.
Communications include, but are not limited to, the following:
• Product information
• Inquiries
• Order handling
• Customer feedback
7.3 Design and Development
7.3.1 Design and development planning
<Business Unit> plans and controls design and development of its products.
Planning activities determine:
• Design and development stages.
• Review, verification, and validation that are appropriate to each design and
development stage.
• Responsibilities and authorities for design and development.
<Business Unit> manages interfaces between different groups involved in design
and development to ensure effective communication. Planning output is updated as
the design and development progresses.
7.3.2 Design and development inputs
<Business Unit> ensures that inputs relating to requirements for deliverables are
determined and records maintained. Inputs may include:
• Functional and performance requirements.
• Applicable statutory and regulatory requirements.
• Where applicable, information derived from previous similar designs.
• Other requirements essential for design and development.
Qualified personnel review the requirements for adequacy and completeness and
resolve any issues.
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7.3.3 Design and development outputs
<Business Unit> ensures that the outputs of design and development are in a format
suitable to manufacturing and capable of verification against design and
development input. These outputs generally consist of:
• PDRDs
• Design rules
• iTech files
• Design library
• Vendor Design Approval (VDA)
• SPEED BOM specification
• Netlist/pin map
The outputs of design and development (baseline) are approved prior to release to
ensure that they:
• Meet input requirements for design and development.
• Provide appropriate information for purchasing and production operations.
• Contain or reference product acceptance criteria.
• Specify the characteristics of the product that are essential for its safe and
proper use.
7.3.4 Design and development review
At suitable stages, individuals involved with product design and development meet
to:
• Evaluate the ability of the results of design and development to fulfill
requirements.
• Identify any problems and propose necessary actions.
Review results and action items are maintained.
7.3.5 Design and development verification
Design and development verification is the process by which individuals involved
with design and development demonstrate that outputs have satisfied the design and
development input requirements. Verification provides a preliminary assessment of
the package’s manufacturability.
<Business Unit> has documented procedures that establish the points at which
verification activities are performed. Verification records and action items are
maintained.
7.3.6 Design and development validation
Design and development validation is the process by which individuals involved
with product design and development demonstrate that the resulting product is
capable of fulfilling the requirements for the specified use or application.
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<Business Unit> has documented procedures that establish when in the design and
development process validation is performed. Validation records and action items
are maintained.
7.3.7 Control of design and development changes
Authorized <Business Unit> personnel identify, document, review, and approve all
design and development changes before implementation. Records of the results of
the change review and action items are maintained.
7.4 Purchasing
Purchases and services that impact the quality of products delivered to <Business Unit>
customers are strictly controlled. The type and extent of control applied to the supplier and
the purchased product are dependent on the effect of the purchased product on subsequent
product realization or the final product. Controls are exercised by departments inside and
outside <Business Unit> depending on the purchased product or service.
7.4.1 Purchasing process
<Business Unit> controls its purchasing processes to ensure that direct and indirect
materials:
• Conform to requirements.
• Reach manufacturing without interruption.
• Are procured from approved suppliers.
The responsible commodity management team evaluates and selects suppliers on
the basis of their ability to meet <Business Unit>’s requirements, including, as
applicable, having a quality management system and meeting any stated product-
or service-specific quality assurance requirements.
The responsible commodity team performs subsequent reevaluations at prescribed
intervals using methods including, but not limited to, those in the following list:
• A formal assessment process of the supplier’s capability to supply products
and/or services.
• Analysis of data in relation to key parameters; for example, delivery
performance and material rejects
• Feedback received.
• Evaluation at the time of subcontract renewal.
Evaluation records and action items arising from the evaluation are maintained.
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7.4.2 Purchasing information
<Business Unit> ensures that its purchasing documents are approved prior to
submitting them to the supplier. During the approval process, information relating
to the particular purchase is checked for accuracy and adequacy of the specified
requirements. Purchasing information may include:
• Drawings.
• Specifications.
• References to part numbers and descriptions.
• Requirements for approval of product, procedures, processes, and equipment.
• Requirements for qualification of personnel.
• Verification arrangements at the supplier’s premises and method of product
release.
• Supplier quality management system requirements.
<Business Unit> maintains records of all its purchasing documents.
7.4.3 Verification of purchased product
<Business Unit> has established and implemented inspection and other activities
necessary for ensuring that purchased product meets specified purchase
requirements.
When the applicable contract with the supplier allows, <Business Unit>’s
representatives may audit the supplier’s premises. Also, when specified under
contract and allowable under the contract with <Business Unit>’s suppliers,
<Business Unit>’s customers or their representatives will be afforded the
opportunity to visit the supplier’s premises to perform verification.
7.5 Production Provision
7.5.1 Control of production operations
<Business Unit> plans and carries out production operations under controlled
conditions. Controlled conditions include, as applicable:
• Availability of information that describes the characteristics of the product.
• Availability of work instructions at points of use.
• Use of suitable equipment.
• Availability and use of measuring and monitoring devices.
• Implementation of monitoring and measurement activities.
• Implementation of release, delivery, and any applicable post-delivery activities.
7.5.1.1 Control of processes and equipment
The processes and equipment used to produce new package technology are
initially qualified under controlled conditions. Platform managers define
the transfer requirements for high-volume manufacturing.
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The methods used to qualify equipment purchased to support increasing
product demand are described in procurement specifications and/or
contracts. Additional equipment characterization requirements are defined
in Change Control Board (CCB) documents.
7.5.1.2 Process sequence and recipes
The procedures and recipes for each process step are documented in
controlled documents, which typically include the following:
• Individual process operating specifications
• Bills of materials (BOMs)
• Basic product specifications (BPSs)
• Special customer specifications (S-specs)
• Online Summary of Electrical Test (OSET)
The correct production sequences are controlled and planned using
WorkStream. Information contained in WorkStream includes the product
routes, operation numbers, processing data, and other information
necessary to support the manufacturing process. The progress of a product
or group of products through a production route is controlled and
monitored in WorkStream. WorkStream is accessible using computer
terminals located throughout the factory.
7.5.1.3 Process change control/process improvement
Changes to continually improve qualified processes, testing, equipment, or
indirect and direct materials are documented and controlled by the
appropriate CCB. To maintain the integrity of the process, <Business
Unit> verifies the resulting output to ensure that the instituted change has
the desired effect.
7.5.1.4 Statistical process control
Where appropriate, statistical process control (SPC) is used on key process
parameters and quality characteristics. Response flow checklists (RFCs) to
correct out-of-control conditions are used where appropriate. The details
of the SPC system and other monitors are documented in individual
process specifications.
7.5.2 Validation of processes for production
Validation of processes for production demonstrates the ability of processes to
achieve planned results. At appropriate intervals in the realization process,
<Business Unit> validates processes where:
• Subsequent monitoring or measurement cannot verify the resulting output.
• Deficiencies in the product may become apparent only after the product is in
use.
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<Business Unit> validation arrangements of these processes include, as applicable:
• Defined criteria for review and approval of the processes.
• Approval of equipment and qualification of personnel.
• Use of specific methods and procedures.
• Records requirements.
• Revalidation.
7.5.3 Identification and traceability
<Business Unit> identifies, where appropriate, the product by suitable means
throughout product realization, and it identifies the product status with respect to
monitoring and measurement requirements as described below.
7.5.3.1 Identification and traceability control
<Business Unit> maintains product identification and traceability
throughout product realization using a combination of the following
methods:
• Physical segregation
• Fab lot number
• Lot travelers (Assembly Test Process Orders [ATPOs] or Finish Process
Orders [FPOs])
• WorkStream routes
• Product package marking
• Substrate Lot Identifiers (SLIs)
The automated shop floor control system, WorkStream, controls product
routing and traceability. WorkStream routes are programmed to prevent
product from being moved to a future operation until all processing and
data collection at the current operation are complete. This control process
applies to production lots; nonstandard flow products, which are processed
using specialized routes; and die sales, which are normal product
processed through a partial assembly route in accordance with customer
request. WorkStream can be used to trace lots currently in the factory to a
specific location or operation in the factory. Records pertaining to lot
processing (ATPO/FPO) are retained.
Production lots are physically segregated from each other through the use
of approved carts. A lot is carried on a designated cart (or carts), and the
cart carries only one lot to maintain traceability and lot integrity.
7.5.3.2 Monitoring and measurement status
Lot travelers (ATPOs and FPOs) and WorkStream are used to indicate the
status of product within the overall process flow. Manufacturing personnel
record the measurement and monitoring status of each lot on the
appropriate traveler and enter the data into WorkStream.
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Product that has been inspected and has passed the defined quality criteria
is moved to the next operation. Rejected product is physically separated
from acceptable product whenever possible. If physical separation is not
yet possible, the rejected product is clearly identified as reject product and
disposed of according to the governing procedure. Product that has been
placed on hold for production-related problems is identified as “on hold”
and cannot be processed further until its disposition is determined.
7.5.4 Customer property
<Business Unit> identifies, verifies, and protects property and other assets owned
by customers and other interested parties while the property is under its control.
Such property may be provided for use or incorporation into an <Business Unit>
deliverable.
Property that is lost, damaged, or does not meet specification is reported to the
customer and records are maintained.
7.5.5 Preservation of product
<Business Unit> has processes that preserve conformity of product and constituent
product parts during internal processing and delivery to the intended destination.
<Business Unit> personnel are responsible for handling product inside the factory
and for delivery to the Arizona Distribution Center (ADC). ADC is responsible for
packaging and handling of finished product.
Southwest Regional Site Materials and Services monitors direct materials from
point of receipt through storage until it is issued to <Business Unit> manufacturing.
Supplier packaging is maintained as long as possible to ensure proper handling and
storage. Perishable material is coded with expiration dates. Indirect materials are
coded with part numbers and revision levels to ensure that correct revision level
materials are being used in manufacturing.
<Business Unit> product is assembled under appropriate environmental control to
prevent contamination, deterioration, and damage from electrostatic discharge. Use
of automated process equipment and associated carriers minimizes the potential for
damage due to material handling.
<Business Unit> packaging and shipping standards conform to corporate drawing
specifications. Packaging supplies are procured through corporate-contracted
suppliers.
7.6 Control of Monitoring and Measuring Devices
7.6.1 Introduction
<Business Unit>’s processes ensure that monitoring and measurement activities are
carried out in a manner that is consistent with monitoring and measurement
requirements.
<Business Unit> controls, calibrates, and maintains monitoring and measuring
devices needed to provide evidence of conformity of product to determined
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requirements. Manufacturing and support organizations deliver to the Site
Calibration Standards Lab measuring equipment that either needs adjustment or is
due for calibration on or before the calibration due date. Every organization that
comes into contact with measuring equipment has procedures to protect the
equipment from damage and deterioration during handling, maintenance, and
storage.
Monitoring and measuring devices subject to calibration include, but are not
limited to:
• Measurement and test equipment (M&TE).
• Analytical in-process inspection equipment.
• Final test equipment.
• Computer software used in the monitoring and measurement of specified
requirements.
<Business Unit> preventive maintenance and calibration procedures also apply to
monitoring and measuring devices used by suppliers in the Supplier Support
Program (SSP) and by other contractors who actively support the factory.
7.6.2 Calibration safeguards, identification, status, and records
<Business Unit> safeguards measuring equipment from adjustments that would
invalidate measurement results. Measuring equipment subject to calibration control
is uniquely identified. Calibration frequency is documented and controlled by the
Calibration Scheduling System or other appropriate system. Records and results of
calibration and maintenance performed on each piece of equipment are maintained
as specified by the supporting group and factory requirements. Calibration status
appears on a sticker or label affixed to the equipment or in a readily accessible
database or record.
7.6.3 Calibration methods
When performing calibration, qualified <Business Unit> personnel use procedures
that identify the measurements to be made, the accuracies required, and the
calibration settings. The measuring equipment used is capable of the precision and
accuracy requirements, and the uncertainty of each measurement within specified
limits.
Measuring equipment is calibrated or verified at specified intervals or prior to use,
as applicable, against measurement standards traceable to international or national
measurement standards. Where no such standards exist, the basis used for
calibration or verification is recorded.
7.6.4 Corrective action
<Business Unit> initiates appropriate action if measuring equipment is found to be
out of tolerance or in an overdue condition. Appropriate action may include, but is
not limited to, frequency, validity, and product risk reviews as described below.
Records of the results of action taken are maintained and reviewed.
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7.6.4.1 Out-of-tolerance equipment for user/owner and calibrating
departments
When measuring equipment is found in an out-of-tolerance condition, the
using department is notified. The notification includes, but is not be
limited to, all associated measurement data. Departments notified of an
out-of-tolerance device evaluate the impact and possible acceptance of
nonconforming product or services by performing a Disposition Review
Board (DRB). The Quality Systems Engineer generates the DRB in SPEED.
Important: No DRB is required if an out-of-tolerance condition occurs
during initial (first) equipment calibration performed by the Site
Calibration Standards Lab.
7.6.4.2 Overdue equipment for user/owner and calibrating departments
When measuring equipment is found in an overdue condition, the using
department is notified. The notification includes, but is not limited to, all
associated scheduling data. Departments notified of an overdue device
evaluate the impact by performing a Process Trouble Report (PTR). The
Quality Systems Engineer generates the PTR in SPEED.
8 Measurement, Analysis, and Improvement
8.1 Planning Monitoring, Measurement, and Improvement Activities
<Business Unit> plans and implements the monitoring, measurement, analysis, and
improvement processes needed to:
• Demonstrate conformity of processes and product.
• Ensure conformity of the quality management system.
• Continually improve the effectiveness of the quality management system.
<Business Unit> establishes the applicable methods, including statistical techniques and the
specific equipment used for measuring processes and products.
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8.2 Monitoring and Measurement
8.2.1 Customer satisfaction
<Business Unit> gathers, analyzes, and monitors information relating to customer
perception of <Business Unit>’s performance. <Business Unit> uses the sources of
customer satisfaction information to determine if the organization is meeting the
needs and expectations of <Business Unit>’s customers. Results are reported to the
<Business Unit> management staff as part of the management review process, and
records and action items are maintained.
8.2.2 Internal and external audits
<Business Unit> conducts internal audits at planned intervals in all areas of the
organization where the quality of deliverables to the customer is affected.
<Business Unit> also facilitates second-party audits from Corporate Quality
Assessment and third-party audits from the Registering Authority. These audits:
• Verify compliance of the quality management system to product realization
plans, the requirements of ISO 9001:2000 and internal specifications, as
appropriate, and the quality management system requirements established by
<Business Unit>.
• Determine whether the quality management system has been effectively
implemented and maintained.
• Help drive continual improvement throughout <Business Unit>.
8.2.2.1 Quality audit implementation
Quality system audits are the defined responsibility of the Quality Systems
Department. Audits are:
• Carried out annually or as needed in line with documented procedures
and responsibilities. Audit frequency is based on business needs and/or
maturity system.
• Performed in a manner that ensures objectivity and impartiality of the
audit process. Auditors do not audit their own work.
• Defined, planned, and scheduled on the basis of the status and
importance of the activities and areas to be audited, as well as on the
results of previous audits.
In addition to internal audits, the manufacturing floor performs self-audits
annually or as needed.
8.2.2.2 Audit results, follow-up, and records
The results of audits are formally recorded, along with timely
corrective/preventive action and the time frame agreed on by personnel
having responsibility in the areas audited. The effectiveness of the
corrective/prevention action is reviewed as needed with personnel
independent from the audited areas either during a subsequently scheduled
audit or randomly.
DOCUMENT NUMBER: 99-9999 PAGE 35 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
The status and effectiveness of corrective and preventive actions, as well
as audit results and trends, are assessed and reviewed as part of the
management review process.
8.2.2.3 Continual improvement
Audit and assessment results are analyzed to identify root causes of
problems. Organization-wide issues are identified and presented to
management. The approach ensures the continual improvement of the
quality management system, while it mitigates the recurrence of problems
and nonconformities.
8.2.3 Monitoring and measurement of processes
At pertinent stages of the realization process, <Business Unit> monitors and, where
applicable, measures the performance of its processes. Records and action items are
maintained.
Measures of process performance that may be incorporated into various realization
processes include the following indicators:
• Capability
• Cost allocation and reduction
• Cycle time or throughput
• Measurable aspects of dependability
• Yield
• Effectiveness and efficiency of people
• Reaction time
• Utilization of technologies
• Waste reduction
8.2.4 Monitoring and measurement of deliverables
At pertinent stages of the realization process, <Business Unit> monitors and, where
applicable, measures product characteristics. Verification (inspection) records and
the test history of each production lot are maintained in WorkStream. Records are
also maintained as specified by the relevant documentation, including the name of
the person authorizing release of the deliverable.
8.3 Control of Nonconforming Product
<Business Unit> ensures that nonconforming product is identified and controlled to prevent
its unintended use or delivery. Nonconforming data are collected and analyzed, and records
and action items are maintained.
8.3.1 Disposition Review Board
A DRB is convened to confirm that questionable product is normal or
indistinguishable from normal and to determine the disposition of such product. A
DOCUMENT NUMBER: 99-9999 PAGE 36 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
DRB is required when routine dispositioning procedures do not specify the
appropriate disposition.
8.3.2 Material Review Board
A Material Review Board (MRB) is convened to evaluate the shipment of
nonconforming product. Nonconforming product is shipped only with the consent
of a Quality and Reliability (Q&R) engineer, the customer, and/or Product Division.
8.4 Analysis of Data
<Business Unit> identifies, collects, and analyzes appropriate data to:
• Demonstrate the effectiveness of the quality management system.
• Evaluate improvement and performance opportunities.
8.5 Improvement
8.5.1 Continual improvement
<Business Unit> plans and manages the processes necessary for the continual
improvement of its quality management system.
8.5.2 Corrective and preventive actions
<Business Unit> documents and follows processes that review nonconforming
product and evaluates the need for correction and preventive actions. The results of
corrective and preventive actions taken are recorded and reviewed.
Examples of <Business Unit> processes that may initiate corrective and preventive
actions are:
• Management review of quality systems
• Internal and external audits and self-audits
• Incoming material quality control inspections
• Dispositioning of nonconforming product, including DRBs and MRBs
• Yield review and low-yield analysis
• Customer feedback, including Functional Analysis Correlation Requests
(FACRs)
• External Administrative Customers Issues (EACIs)
• Customer Quality Incident Report (CQIR)
8.5.3 Customer feedback system
<Business Unit> sometimes receives feedback from <Company>’s customers
(through the <Company> Quality Support Center) in the form of FACRs and
EACIs. <Company>’s Customer Quality Engineers may raise awareness of certain
high-impact issues by generating a CQIR.
DOCUMENT NUMBER: 99-9999 PAGE 37 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
8.5.4 Corrective action tracking
The coordinator/owner for each process that is part of the formal corrective/-
preventive action system is responsible for tracking corrective and preventive
actions.
8.5.5 Corrective/preventive action implementation
Implementation of corrective and preventive actions is prioritized as necessary
based on factory requirements and customer expectations. Corrective and
preventive actions that require process changes are reviewed and approved for
implementation by the appropriate Process Change Control Board (PCCB). The
results of actions taken are recorded.
8.5.6 Corrective/preventive action escalation
Any issues identified within the formal corrective/preventive action system that
require escalation due to priority, risk, or resourcing may be escalated using any of
the following people or systems:
• Platform manager
• Department manager
• Manufacturing shift manager
• Quality and Reliability Manager
• ISO Management Representative
• Management review process
• Other communication forums as appropriate
9 Revision History
Rev. Date Description Initiator
08 10/12/98 Renew spec without content changes. <Name>
09 2/5/99 Complete rewrite, reformat to comply with governing
spec 7-section formatting.
<Name>
10 4/2/99 CN – To comply with ISO audit finding in
development of a more robust and closed loop system
for dealing with out-of-tolerance and overdue
measurement and test equipment that require
calibration from the site(s) Standard Calibration Lab.
<Name>
11 5/26/99 CN – Clarify when a DRB should not occur. <Name>
12 02/14/00 CN – Rewrite. <Name>
13 10/13/00 Complete rewrite using new template to comply with
ISO 9001:2000
<Name>
DOCUMENT NUMBER: 99-9999 PAGE 38 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
10 Appendices
10.1 Key Organizational Responsibilities
The responsibility, authority, and interrelationship of all personnel who manage, perform,
and verify work are defined in organizational charts, by procedures within the various
organizations, focus areas, and functional work groups, and in the following matrix:
Important:
• Refer to 5.5.3 for a description of the responsibilities assigned to the <Business Unit>
Director and the <Business Unit> ISO Management Representative.
• Organizations and focus areas in rows bordered by dashed lines are outside <Business
Unit> but provide specified support functions.
Organization Focus Areas
Roadmap and Business Process
Management (RBPM)
• Product and Technology Integration
• CPU Packaging and Enabling Roadmaps
• Technology Assessments and Communications
• Package Technology Management and Capability Roadmaps
Design Process Development
(DPD)
• Design Tool Development
• Thermal/Mechanical Tools and Analysis
• Electrical Modeling and Analysis
• Mechanical Design and Integration
• Package Design and Integration
• Design Processes
Platform, Materials and Enabling
Development (PMED)
• Platform Integration
• Materials
• Enabling
• Substrate Assembly Subcontractors
Module Engineering • Process Engineering
• Process Change Control Board
DOCUMENT NUMBER: 99-9999 PAGE 39 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
Organization Focus Areas
Automation • Equipment Integration
• Engineering Analysis
• Shop Floor Control
• Infrastructure
• Planning and Logistics Group (PLG)
• Test Automation
• Change Requests
• Change Control Board
• MDT
• Operations
Factory Operations • Manufacturing
• Manufacturing Systems
• Industrial Engineering
• Build Logistics
Organizational Effectiveness
Programs
• Organizational Development
• Salaried Non-Exempt/Exempt/First Line Management (FLM)
Development
• Mentoring
• Embedded Staffing and Sourcing
• Statistical Applications
• Factory Support
• Peer Training Systems
• Business Practices
• Safety
• Employee Relations Self-Assessment (ERSA)
• Quality Systems Audit
• Document Management Information Services
• Learning Technologies Integration and Validation
Quality and Reliability (Q&R) • Platform and Enabling Quality and Reliability Engineering
(QRE)
• Materials Analysis
• Failure Analysis
• Fault Isolation
• Product QRE
• Customer and Sustaining Engineering
Quality and Reliability
Engineering Support
• Product reliability stress
• Preventive maintenance and calibration of equipment and
tools
DOCUMENT NUMBER: 99-9999 PAGE 40 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
Organization Focus Areas
Product Engineering • Product sample and early revenue requirements management
• Primary interface to Product Division
• Division to Virtual Factory coordination
• Product silicon test software (Test Change Control Board,
Component test, Burn-in, PC Platform Validation)
Southwest Regional Site Materials
and Services (SMS)
• Process support facilities
• Facilities support equipment
• Preventive and corrective maintenance of facilities support
and monitoring equipment
DOCUMENT NUMBER: 99-9999 PAGE 41 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
10 Appendices
10.2 ISO 9001:2000/<Business Unit> Quality Manual Matrix
ISO Clause
<Business Unit> Quality Manual
Section
∗∗∗∗
1.2 Application .............................................................. 4.2.1, 5.5.1, 7
4 Quality management system ............................................. 1
4.1 General requirements .............................................. 1
4.2 Documentation requirements .................................. 4.3
4.2.1 General ........................................................ 4.3
4.2.2 Quality manual ............................................ 4.3, 4.4
4.2.3 Control of documents .................................. 4.3.2, 4.4, 4.5, 4.6
4.2.4 Control of quality records ............................ 3, 4.3.3, 4.4.4, 4.5, 4.6, 5.6.3, 6.1,
6.2.4, 7.1.1, 7.2.2, 7.3.4, 7.3.5, 7.3.6,
7.3.7, 7.4.1, 7.4.2, 7.5.2, 7.6.2, 7.6.4,
8.2, 8.5.2, 8.5.5
5 Management responsibility .............................................. 5
5.1 Management commitment ....................................... 5.1, 5.5.3, 5.6, 6, 10.1
5.2 Customer focus ........................................................ 5.2, 7.2
5.3 Quality policy .......................................................... 5.3, 5.5.2, 5.6.1
5.4 Planning ................................................................... 5.4
5.4.1 Quality objectives ........................................ 5.4.1, 5.4.2
5.4.2 Quality management system planning ........ 4.6, 5.4.2, 6, 7.1, 7.3.1, 8.1, 8.5.1
5.5 Responsibility, authority and communication ......... 5.5
5.5.1 Responsibility and authority ........................ 5.3.1, 5.4.1, 5.5.1, 5.5.2, 5.5.3, 5.6,
10.1
5.5.2 Management representative ......................... 5.5.3
5.5.3 Internal communication ............................... 5.3.3, 5.5.3, 6.2, 10.1
5.6 Management review ................................................ 5.6
5.6.1 General ........................................................ 4.4.3, 5.4.2, 5.6.1
5.6.2 Review input ................................................ 5.6.2, 8.2.1, 8.2.2.2, 8.5.2, 8.5.6
∗∗∗∗
Boldface = Strong relationship between the <Business Unit> Quality Manual and the ISO 9001:2000
clause.
DOCUMENT NUMBER: 99-9999 PAGE 42 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
ISO Clause
<Business Unit> Quality Manual
Section
∗∗∗∗
5.6.3 Review output .............................................. 5.6.3, 4.6
6 Resource management ..................................................... 6
6.1 Provision of resources ............................................. 5.1, 6
6.2 Human resources ..................................................... 6.1, 6.2
6.2.1 General ........................................................ 5.1, 6.1, 6.2
6.2.2 Competence, awareness and training .......... 4.6, 6.2
6.3 Infrastructure ........................................................... 6.3
6.4 Work environment .............................................. 6.4
7 Product realization ....................................................... 7
7.1 Planning of product realization ............................... 5.4.2, 4.6, 6, 7.1, 7.2.2, 7.3.3, 7.3.5,
7.3.6, 8.1
7.2 Customer-related processes ..................................... 7.2
7.2.1 Determination of requirements related to
the product ................................................... 5.2, 7.2.1
7.2.2 Review of requirements related to the
product ......................................................... 4.6, 7.2.2
7.2.3 Customer communication ............................ 7.2.3, 8.5.3
7.3 Design and development ......................................... 7.3
7.3.1 Design and development planning ............... 5.4.2, 7.3.1
7.3.2 Design and development inputs .................. 4.6, 7.3.2
7.3.3 Design and development outputs ................ 7.3.3, 7.5
7.3.4 Design and development review ................. 4.6, 7.3.4
7.3.5 Design and development verification .......... 4.6, 7.3.5
7.3.6 Design and development validation ............ 4.6, 7.3.6
7.3.7 Control of design and development
changes ........................................................ 4.6, 7.3.7
7.4 Purchasing ............................................................... 7.4
7.4.1 Purchasing process ...................................... 4.6, 7.4.1, 8.4
7.4.2 Purchasing information ............................... 4.6, 7.4.2
7.4.3 Verification of purchased product ............... 7.4.3
7.5 Production and service provision ............................ 7.5
DOCUMENT NUMBER: 99-9999 PAGE 43 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
ISO Clause
<Business Unit> Quality Manual
Section
∗∗∗∗
7.5.1 Control of production and service
provision ...................................................... 7.5.1
7.5.2 Validation of processes for production
and service provision.................................... 4.6, 6.2.3, 7.5.2
7.5.3 Identification and traceability ...................... 4.6, 7.5.3, 8.3
7.5.4 Customer property ....................................... 7.5.4
7.5.5 Preservation of product ............................... 7.5.5
7.6 Control of monitoring and measuring devices ........ 4.6, 7.2.1, 7.6, 8.3
8 Measurement, analysis and improvement ........................ 8
8.1 General .................................................................... 5.4.2, 7.1, 8.1, 8.2
8.2 Monitoring and measurement .................................. 8.2
8.2.1 Customer satisfaction .................................. 5.6.2, 8.2.1, 8.5.3
8.2.2 Internal audit .............................................. 4.6, 5.6.2, 8.2.2, 8.4, 8.5.1
8.2.3 Monitoring and measurement of
processes ...................................................... 4.6, 8.2.3, 8.4
8.2.4 Monitoring and measurement of product .... 4.6, 8.2.4, 8.3, 8.4
8.3 Control of nonconforming product .......................... 8.3, 8.4
8.4 Analysis of data ....................................................... 5.6.2, 7.4.1, 8.2.1, 8.2.2.3, 8.2.3,
8.2.4, 8.3, 8.4
8.5 Improvement ........................................................... 8.5
8.5.1 Continual improvement ............................... 5.3.1, 5.4, 5.6, 8.2.2.3, 8.4, 8.5.1,
8.5.2
8.5.2 Corrective action ......................................... 4.6, 7.6.4, 8.5
8.5.3 Preventive action ......................................... 4.6, 8.5
DOCUMENT NUMBER: 99-9999 PAGE 44 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
10 Appendices
10.3 <Business Unit> Quality Manual/Quality Management System Documentation
Matrix
The table below lists the sections by number and title of the <Business Unit> Quality
Manual along with the applicable quality management system documentation associated
with the quality manual (QM) sections.
Sec. QM Section Title Quality Management System Documentation
1 Purpose
2 Scope
3 Applicable Documents
4 General
4.1 Definitions 99-9999 <Business Unit> Quality Manual
4.2 <Business Unit>
Profile
NA
4.3 Quality Management
System
Documentation
99-9999 <Business Unit> Quality Manual
99-9999 Departmental Document Control Policies and
Procedures
4.4 Quality Manual 99-9999 <Business Unit> Quality Manual
99-9999 Distribution of Controlled Documents
99-9999 DMIS “<Company> Confidential” Requirements
4.5 Control of
Documents
99-9999 Document Management Information Services
Governing Spec for 99-XXXX SECC Documents
99-9999 Document Management Information Services Policies
and Procedures for <Business Unit> Series
Specifications
99-9999 Departmental Document Control Policies and
Procedures
99-9999 Distribution of Controlled Documents
99-9999 DMIS “<Company> Confidential” Requirements
4.6 Control of Quality
Records
99-9999 Virtual Factory Quality Records Retention
Policies/Procedures
5 Management Responsibility
5.1 Management
Commitment
99-9999 Departmental Document Control Policies and
Procedures
5.2 Customer Focus
5.3 Quality Policy 99-9999 <Business Unit> Quality Manual
5.4 Planning
DOCUMENT NUMBER: 99-9999 PAGE 45 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
Sec. QM Section Title Quality Management System Documentation
5.5 Responsibility,
Authority, and
Communication
99-9999 <Business Unit> Quality Manual
5.6 Management Review 99-9999 <Business Unit> Management Review Policy and
Procedure
6 Resource Management
6.1 Assignment of
Personnel
6.2 Competence,
Awareness, and
Training
99-9999 Training Guidelines and Procedures for <Business
Unit>
New Hire Orientation Documentation
6.3 Infrastructure
6.4 Work Environment <Business Unit> Manufacturing Safety Handbook
Office Safety Handbook
7 Product Realization
7.1 Planning of Product
Realization
7.2 Customer-Related
Processes
99-9999 Change Management Specification
Plan It Manual
7.3 Design and
Development
99-9999 Assembly/Test CCB Policies and Procedures
99-9999 Change Management Specification
99-9999 DPD Department Operations Process
99-9999 Software Development Process
99-9999 Product Design Integration Process
99-9999 Enabling Design Process
99-9999 Technology Design Integration Process
99-9999 Design Validation Process
99-9999 Product Package Design Requirements Document
(PDRD) Process
Applicable design rules
Applicable library standards
7.4 Purchasing <Business Unit> Materials Desktop Procedures
DOCUMENT NUMBER: 99-9999 PAGE 46 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
Sec. QM Section Title Quality Management System Documentation
7.5 Production Provision 99-9999 Procurement specification for (Commodity) Materials
99-9999 <Business Unit> ESD Requirements
99-9999 Assembly/Test CCB Policies and Procedures
99-9999 Traceability and Bottomside Marking Requirements
99-9999 Standard Lot Numbering Specification
99-9999 Virtual Factory Quality Records Retention
Policies/Procedures
99-9999 Chandler, AZ Site Environmental Controls
Specification
99-9999 Unit Integrity/ Reject Management Specification
99-9999 C4/OLGA Traceability Requirements
99-9999 WorkStream Policies and Procedures for C4 OLGA and
FC-PGA
99-9999 C4/FC-PGA Class 10,000 Cleanroom Protocol Guideline
99-9999 C4/FC-PGA Class 100,000 Cleanroom Protocol
Guideline
99-9999 OLGA1, OLGA2, INT2, FC-PGA VF and MCM On-
Hold/Off-Hold System Procedure
99-9999 Pack Procedure
Applicable process operating and other specifications
AzLO Desktop Operating Procedures
Handling and storage procedures documented in individual
specifications
Online Summary of Electrical Test (OSET)
Product build kits
7.6 Control of
Monitoring and
Measuring Devices
99-9999 Arizona Standards Lab Calibration Procedures
99-9999 Measuring Equipment and Calibration Policy
99-9999 Virtual Factory Assembly/Test Manufacturing
Preventive Maintenance and Calibration Spec
Individual manufacturing equipment specifications
8 Measurement, Analysis, and Improvement
8.1 Planning Monitoring,
Measurement, and
Improvement
Activities
DOCUMENT NUMBER: 99-9999 PAGE 47 OF 47
<COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP
IF PRINTED – REFERENCE COPY
Sec. QM Section Title Quality Management System Documentation
8.2 Monitoring and
Measurement
99-9999 Procurement specification for (Commodity) Materials
99-9999 ATMO Spec Template for 08 Series Specs
99-9999 A/T Internal Audit Policies & Procedures for Virtual
Factories
99-9999 A/T Self Audit Policies & Procedures for Virtual
Factories
99-9999 <Business Unit>/ATM Quality Audit Corrective Action
Tracking Procedure using Speed
99-9999 FC-PGA/INT2 and OLGA VF Inspection Trouble Report
(ITR) Procedures
99-9999 C4 & FC-PGA VF Material and Disposition Review
Board Procedure
99-9999 Final Visual Inspection Procedure
99-9999 FC-PGA/INT2 and OLGA Virtual Factory Final QA
Minimum Lot Acceptance Inspections Requirements
and Procedure
99-9999 Quality System Auditing Policy
8.3 Control of
Nonconforming
Product
99-9999 Material and Disposition Review Board procedure
99-9999 Unit Integrity/Reject Management Specification
99-9999 OLGA1 and FC-PGA VF Process Trouble Report System
99-9999 Yield Issue Procedures and Guidelines
99-9999 OLGA1, OLGA2, INT2, FC-PGA VF and MCM On-
Hold/Off-Hold System Procedure
99-9999 C4 & FCPGA VF Material and Disposition Review
Board Procedure
8.4 Analysis of Data
8.5 Improvement 99-9999 Assembly/Test CCB Policies and Procedures
99-9999 A/T Internal Audit Policies & Procedures for Virtual
Factories
99-9999 Excursion (DRB/MRB/ITR/PTR)
Notification/Documentation in SPEED – Policies and
Procedures
99-9999 C4 & FC-PGA VF Material and Disposition Review
Board Procedure
Departmentally controlled procedures for yield management
Departmentally controlled procedures for FACRs
Sample q ma1
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Sample q ma1

  • 1. DOCUMENT NUMBER: 99-9999 PAGE 1 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY EV CN #: DESCRIPTION: 08 CAT-98-2251 Renew spec without content changes – <Name> – 10/12/98 (rm) 09 CAT -99-0275 Complete rewrite, reformat to comply with governing spec 7-section formatting – <Name> – 2/5/99 – (rm) 10 CAT -99-0596 CN – To comply with ISO audit finding in development of a more robust and closed loop system for dealing with out-of-tolerance and overdue measurement and test equipment that require calibration from the site(s) Standard Calibration Lab – <Name> – 4/2/99 (rm) 11 CAT -99-0920 CN – Clarify when a DRB should not occur – <Name> – 5/26/99 – (ks) 12 CAT -00-0162 CN – Rewrite by <Name> – 02/14/00 – (ks) 13 Draft Complete rewrite using new template to comply with ISO 9001:2000 – (ks) DISTRIBUTION AND QUANTITY: “B” LOOP C-DMIS 1 Trng Pod 1 APPROVALS: ISSUE DATE: SPEC OWNER: <Name> * REVIEW CYCLE: Annual QUALITY SYSTEMS MANAGER: <Name> * EXPIRATION DATE: <BUSINESS UNIT> TRAINING: <Name> * GROUP RESPONSIBLE: Quality Systems Department *Signatures/Master on File in <Business Unit> DMIS TITLE: <Business Unit> Quality Manual
  • 2. DOCUMENT NUMBER: 99-9999 PAGE 2 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Table of Contents 1 Purpose............................................................................................................................. 5 2 Scope................................................................................................................................ 5 3 Applicable Documents ...................................................................................................... 5 4 General ............................................................................................................................. 6 4.1 Definitions................................................................................................................. 6 4.2 <Business Unit> Profile ............................................................................................ 7 4.2.1 <Business Unit> history................................................................................ 7 4.2.2 <Business Unit> vision ................................................................................. 8 4.2.3 <Business Unit> mission statement ............................................................. 8 4.2.4 <Business Unit> values................................................................................ 8 4.3 Quality Management System Documentation........................................................... 9 4.3.1 <Business Unit> quality management system.............................................. 9 4.3.2 <Business Unit> documentation and documentation levels ......................... 9 4.3.3 Quality records ........................................................................................... 10 4.4 Quality Manual........................................................................................................ 10 4.4.1 Classification and control............................................................................ 10 4.4.2 Distribution ................................................................................................. 10 4.4.3 Review and revision ................................................................................... 11 4.4.4 Approval ..................................................................................................... 11 4.5 Control of Documents............................................................................................. 11 4.6 Control of Quality Records...................................................................................... 12 5 Management Responsibility ............................................................................................ 13 5.1 Management Commitment ..................................................................................... 13 5.2 Customer Focus ..................................................................................................... 13 5.3 Quality Policy.......................................................................................................... 14 5.3.1 <Business Unit> quality policy.................................................................... 14 5.3.2 <Company> mission and quality value statements .................................... 14 5.3.3 Communicating the <Business Unit> quality management system to employees ............................................................................................................. 14 5.4 Planning.................................................................................................................. 14 5.4.1 Quality objectives ....................................................................................... 14 5.4.2 Quality management system planning ....................................................... 15 5.5 Responsibility, Authority, and Communication........................................................ 15 5.5.1 <Business Unit> quality management structure ......................................... 15 5.5.2 Deployment responsibilities of management.............................................. 16 5.5.3 Personnel responsible for quality implementation ...................................... 18 5.6 Management Review.............................................................................................. 18 5.6.1 Frequency .................................................................................................. 18 5.6.2 Review items.............................................................................................. 19 5.6.3 Review outcome......................................................................................... 19
  • 3. DOCUMENT NUMBER: 99-9999 PAGE 3 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 6 Resource Management................................................................................................... 19 6.1 Assignment of Personnel........................................................................................ 19 6.2 Competence, Awareness, and Training.................................................................. 20 6.2.1 Commitment to training .............................................................................. 20 6.2.2 Identifying competency needs and developing training schedules............. 20 6.2.3 Technical training and evaluation............................................................... 20 6.2.4 Training records ......................................................................................... 21 6.3 Infrastructure .......................................................................................................... 21 6.4 Work Environment.................................................................................................. 21 7 Product Realization......................................................................................................... 22 7.1 Planning of Product Realization.............................................................................. 23 7.1.1 Creating product-specific quality plans....................................................... 23 7.1.2 Quality plan documentation........................................................................ 23 7.2 Customer-Related Processes................................................................................. 24 7.2.1 Determination of requirements related to deliverables ............................... 24 7.2.2 Review of requirements related to deliverables.......................................... 24 7.2.3 Customer communication........................................................................... 25 7.3 Design and Development ....................................................................................... 25 7.3.1 Design and development planning ............................................................. 25 7.3.2 Design and development inputs ................................................................. 25 7.3.3 Design and development outputs............................................................... 26 7.3.4 Design and development review ................................................................ 26 7.3.5 Design and development verification.......................................................... 26 7.3.6 Design and development validation............................................................ 27 7.3.7 Control of design and development changes ............................................. 27 7.4 Purchasing.............................................................................................................. 27 7.4.1 Purchasing process.................................................................................... 27 7.4.2 Purchasing information............................................................................... 28 7.4.3 Verification of purchased product............................................................... 28 7.5 Production Provision............................................................................................... 29 7.5.1 Control of production operations ................................................................ 29 7.5.2 Validation of processes for production ....................................................... 30 7.5.3 Identification and traceability ...................................................................... 31 7.5.4 Customer property...................................................................................... 32 7.5.5 Preservation of product .............................................................................. 32 7.6 Control of Monitoring and Measuring Devices........................................................ 32 7.6.1 Introduction................................................................................................. 32 7.6.2 Calibration safeguards, identification, status, and records ......................... 33 7.6.3 Calibration methods ................................................................................... 33 7.6.4 Corrective action ........................................................................................ 33 8 Measurement, Analysis, and Improvement ..................................................................... 34 8.1 Planning Monitoring, Measurement, and Improvement Activities ........................... 34 8.2 Monitoring and Measurement................................................................................. 35 8.2.1 Customer satisfaction................................................................................. 35
  • 4. DOCUMENT NUMBER: 99-9999 PAGE 4 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 8.2.2 Internal and external audits ........................................................................ 35 8.2.3 Monitoring and measurement of processes................................................ 36 8.2.4 Monitoring and measurement of deliverables............................................. 36 8.3 Control of Nonconforming Product ......................................................................... 37 8.3.1 Disposition Review Board........................................................................... 37 8.3.2 Material Review Board ............................................................................... 37 8.4 Analysis of Data...................................................................................................... 37 8.5 Improvement........................................................................................................... 37 8.5.1 Continual improvement .............................................................................. 37 8.5.2 Corrective and preventive actions .............................................................. 37 8.5.3 Customer feedback system........................................................................ 38 8.5.4 Corrective action tracking........................................................................... 38 8.5.5 Corrective/preventive action implementation.............................................. 38 8.5.6 Corrective/preventive action escalation...................................................... 38 9 Revision History .............................................................................................................. 39 10 Appendices .....................................................................................................................40 10.1 Key Organizational Responsibilities ....................................................................... 40 10.2 ISO 9001:2000/<Business Unit> Quality Manual Matrix......................................... 43 10.3 <Business Unit> Quality Manual/Quality Management System Documentation Matrix...................................................................................................................... 46 10.4 Abbreviations.......................................................................................................... 50
  • 5. DOCUMENT NUMBER: 99-9999 PAGE 5 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY <Business Unit> Quality Manual 1 Purpose The <Business Unit> Quality Manual serves several purposes. The manual: • Establishes a concise outline of <Business Unit>’s quality management system, including the strategies for achieving and maintaining quality standards across all processes that comprise <Business Unit>’s quality management system. • Provides a reference for <Business Unit>’s quality management system procedural documentation and work instructions. • Identifies and designates the responsibility and authority for implementing and maintaining <Business Unit>’s quality management system. • Establishes and demonstrates compliance of <Business Unit>’s quality management system with the International Organization of Standardization (ISO) 9001:2000 standard. 2 Scope This document applies to <Business Unit>. It complies with all requirements of ISO 9001:2000 but may contain information beyond the scope of ISO 9001:2000 registration. 3 Applicable Documents Number Title ISO 9001:2000(E) Quality management systems – Requirements http://legal.<Company>. com/crm/index.htm Corporate Records Management Document Retention Guidelines http://legal.<Company>. com/crm/index.htm Corporate Records Management Document Handling Procedures http://services.<Company>. com/EHS Various corporate Environmental Health and Safety guidelines
  • 6. DOCUMENT NUMBER: 99-9999 PAGE 6 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 4 General 4.1 Definitions Definitions for the terms used in this document are as follows: Term Description Controlled distribution The automatic distribution of controlled documents to controlled locations where the documents are used. Controlled distribution ensures that documents are distributed every time they are modified, including revisions, renewals, and Temporary Engineering Instructions (TEIs), or rendered obsolete. Controlled document A document that: • Meets Information Security requirements for creation, approval, distribution, and retrieval. • Is legible and readily identifiable. Additionally, controlled documents may be defined by either or both of the following criteria: • May be used to procure or produce products. • May have an impact on the quality of the deliverable. Controlled documents list A group of indexes that list the current revision status of controlled documents. Customer Recipient of a deliverable resulting from <Business Unit> processes. Deliverable An output from a specific process expressed as a product or a process. Document change control Process by which controlled documents are reviewed and approved by authorized personnel at initial and superseding (revised) issues. ISO 9001 A member of the ISO 9000 family of internationally recognized and accepted standards, specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that meet customer and applicable regulatory requirements and aims to enhance customer satisfaction. Objective evidence Data obtained through observation, measurement, test, or other empirical means that support the existence or verity of something. Management system A set of interrelated or interacting elements for establishing policy and objectives and for achieving those objectives.
  • 7. DOCUMENT NUMBER: 99-9999 PAGE 7 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Term Description Quality The degree to which a set of inherent characteristics of a product, process, or system, to fulfill requirements of the organization, its customers, and other interested parties. Quality management Coordinated activities for directing and controlling an organization with regard to quality. Quality management system A management system for directing and controlling an organization with regard to quality. Direction and control generally include establishment of the quality policy and quality objectives, quality planning, quality control, quality assurance, and quality improvement. Quality manual Document specifying the quality management system of an organization. Quality objective Something sought, or aimed for, related to quality. Quality plan Documentation specifying which procedures and associated resources are to be applied by whom and when to a specific project, product, process, or contract. Quality policy An organization’s overall business commitments toward quality systems, continual improvement, and customer satisfaction as formally expressed by top management. Quality record Documentation that: • States results achieved or provides objective evidence of activities performed in fulfillment of quality requirements. • Is identified by name (as a quality record) in the appropriate controlled document. Quality system The organizational structure, responsibilities, procedures, processes, and resources needed to implement quality management (refer to previous term, Quality management). 4.2 <Business Unit> Profile 4.2.1 <Business Unit> history <Business Unit> is a business unit within <Company>’s <Sector>. <Business Unit>was established in 1992 and merged with <another business unit> in 1998. The <Business Unit>facility includes over 120,000 square feet of manufacturing space, operates 24 hours a day, 7 days a week, and employs approximately 900 full-time employees. As a design, development, and deployment facility of new assembly test technologies, <Business Unit>produces microprocessor and semiconductor products for the worldwide market. The factory is dedicated to the introduction of
  • 8. DOCUMENT NUMBER: 99-9999 PAGE 8 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY new assembly technologies prior to their being transferred to <Company> high- volume manufacturing (HVM) sites. <Business Unit> does not provide direct servicing to its customers, and this is reflected in the reduced scope of <Business Unit>’s ISO 9001:2000-compliant quality management system and quality manual. Likewise, owing to the nature of its processes, non-CPU (Central Processing Unit) activities and concept qualification (Path Finding) activities fall outside the scope of this quality manual. 4.2.2 <Business Unit> vision Interconnecting silicon to the digital world. 4.2.3 <Business Unit> mission statement Identify, develop, and deliver assembly packaging solutions to meet <Company>’s business needs. 4.2.4 <Business Unit> values <Business Unit>is guided by the following values: • Uncompromised integrity and honesty. We trust each other, employ <Company>’s Code of Conduct, and disclose issues and risks fully. • Assume ownership. We own the problem and drive resolution, and we find the right people to get it resolved. • Speak with data. We support our conclusions with data. • Be disciplined. We hold effective meetings, are on time, and employ systematic problem-solving methodology. • Open communication. We explain what we know when we know it. • Make and meet commitments. We base business goals on high-confidence schedules, identify stretch goals to challenge ourselves, and do everything within reason to meet those schedules. • Teamwork. We contribute ideas to result in more options and better problem resolution, we reallocate resources to maximize organization results, and we work as one organization and to one agenda for the common good. • Safety. Safety is owned by everyone. We proactively promote a safe and healthy environment.
  • 9. DOCUMENT NUMBER: 99-9999 PAGE 9 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 4.3 Quality Management System Documentation 4.3.1 <Business Unit> quality management system This manual defines the <Business Unit>quality management system. The quality management system consists of <Business Unit>’s quality manual, procedural documentation and work instructions, quality objectives and quality plans, activities, practices, resources, and quality records which together ensure that <Business Unit>’s deliverables conform to the requirements of the organization, its customers, and other interested parties. 4.3.2 <Business Unit> documentation and documentation levels The <Business Unit>quality management system is documented in sufficient detail to ensure its effective operation and control of processes. Procedural coverage varies depending on the type of activity, the complexity of processes and their interactions, and on the competence of personnel involved in carrying out the activity. The following table shows how <Business Unit>’s quality management system is documented. Each level of documentation contains steadily increasing details about <Business Unit>’s quality operations and methods. Documents that direct activity affecting <Business Unit>’s quality management system are placed under control. Level Documentation Type Describes . . . 1 <Business Unit> Quality Manual <Business Unit>’s quality management system: its scope, the interaction between the processes of the quality management system, and the documented procedures established for the effective operation of that system. 2 Procedural documentation Responsibilities and governing procedures within the <Business Unit> quality system. Samples include the following types of documents: • <Business Unit> operating policies and procedures • Functional group governing procedures, process specifications, and business flow diagrams
  • 10. DOCUMENT NUMBER: 99-9999 PAGE 10 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Level Documentation Type Describes . . . 3 Work instructions Steps to be taken within a specific job function to achieve quality and production plan results. Samples include the following types of documents: • Process operational specifications • Preventive maintenance specifications • Local desktop procedures (LDCs) • Best known methods (BKMs) • Toolkits 4.3.3 Quality records <Business Unit> maintains quality records at each documentation level to demonstrate: • Conformity to specified requirements. • Suitability, adequacy, and effective operation of the quality management system. 4.4 Quality Manual 4.4.1 Classification and control <Business Unit>’s quality manual is classified as <Company> Confidential and is a controlled document. Control is exercised by Document Management Information Services (DMIS). 4.4.2 Distribution DMIS distributes controlled copies of the current revision of <Business Unit>’s quality manual to individuals and departments on request. Uncontrolled copies of <Business Unit>’s quality manual can be viewed and printed by accessing the following online resources: • Documentum (WorkSpace, SmartSpace, Vspec) • The <Business Unit> DMIS shared local repository Copies printed using these access modes are uncontrolled reference copies. Individuals with uncontrolled copies must take responsibility for verifying that they are in possession of the current revision of this quality manual. They do this by contacting DMIS directly or by checking the controlled documents list on the <Business Unit> DMIS shared local repository or on the DMIS shared repository on the <Company> intranet.
  • 11. DOCUMENT NUMBER: 99-9999 PAGE 11 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 4.4.3 Review and revision <Business Unit> employees are encouraged to propose amendments, additions, and improvements to this quality manual through their supervisor or manager or directly to the Quality Systems Manager. Maintenance and revision of <Business Unit>’s quality manual are the responsibility of the <Business Unit> Quality Systems Manager. The manual is reviewed at a minimum on an annual basis and as necessary to incorporate changes in business direction and continual improvement activities. 4.4.4 Approval The <Business Unit> ISO Management Representative approves the release of <Business Unit>’s quality manual. Other approvals may be required at the discretion of designated <Business Unit> management staff. Records of the review and approval processes are maintained. 4.5 Control of Documents <Business Unit> places documents that direct activity affecting its quality management system under strict approval, controlled distribution, and change control, including to the extent applicable documents of external origin such as standards and customer documents. Authorized personnel review and approve controlled documents for adequacy prior to issue, and a quality record is kept of this process. When changes are required to existing documents, designated functions are provided with pertinent information, including recommended improvements and corrective or preventive action implementation, upon which to base their review and approval. The nature of the change and the current revision status are identified in the controlled document. After approval, the relevant version of the document is distributed under controlled conditions to all locations where operations essential to the effective functioning of the quality system are performed. Locations may be authorized distribution points, electronic terminals, or a central or local repository. Members of the affected work group receive relevant training when systems, processes, or procedures are implemented or modified. <Business Unit> promptly removes obsolete (not current) controlled documents from all points of issue or use or otherwise assures against their unintended use. Obsolete controlled documents retained for legal and/or knowledge-preservation purposes are suitably identified. <Business Unit> uses several methods to maintain the current revision status of all <Business Unit> controlled documents. To preclude anyone’s using obsolete documents, DMIS maintains a controlled documents list that is readily accessible to users of the <Business Unit> DMIS shared local repository and the DMIS shared repository located on <Company>’s intranet. In addition, designated personnel who use non-DMIS controlled documents maintain records of the current revision status of their documents; for example, local desktop procedures, best known methods, and toolkits.
  • 12. DOCUMENT NUMBER: 99-9999 PAGE 12 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 4.6 Control of Quality Records <Business Unit> maintains quality records to provide evidence of conformity to specified requirements and of the effective operation of the quality management system. Pertinent quality records from subcontractors are elements of these data. In accordance with <Company> guidelines and procedures, <Business Unit> maintains quality records that: • Are legible and readily identifiable to the product/process involved. • Are retrievable. • Are protected against deterioration, damage, and loss. • Have established retention periods. Retention periods vary from record to record depending on statute or regulation, trade practices, projected business needs, or specific customer requirements. For longer storage periods, quality records are stored off-site. Each functional work group maintains a master index that identifies records that support and substantiate all <Business Unit> quality-related activities. The index specifies, as a minimum, the following: • Name of quality record • Medium (paper, foils, microfilm, magnetic disk or tape, optical disk, photograph, or a combination thereof) • Responsible group ensuring the integrity of the quality record • Location where the quality record is maintained • Retention period • Disposition authority for the quality record 5 Management Responsibility 5.1 Management Commitment <Business Unit> management staff is committed to the development, implementation, and improvement of <Business Unit>’s quality management system. The quality management system rests on the following foundations: • <Business Unit> management staff communicates to employees the importance of the quality management system to the continued success and effectiveness of the organization. • <Business Unit> management staff and personnel are visibly and actively committed to a total quality system and to its continual improvement. • <Business Unit> management staff continually assesses the quality management system’s capability to fulfill customer requirements and expectations. • <Business Unit> management staff ensures planning and allocation of necessary resources, including the assignment of competent personnel.
  • 13. DOCUMENT NUMBER: 99-9999 PAGE 13 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY • <Business Unit> management staff defines responsibilities for personnel who perform work and verify activities affecting quality. • Documented and controlled processes are implemented and maintained. • An effective corrective and preventive action program is implemented and maintained. 5.2 Customer Focus <Business Unit> management staff, with help from other <Company> management teams, ensures that customer requirements (i.e., needs and expectations) are determined, converted into specific requirements related to the deliverable, and fulfilled with the goal of enhancing customer satisfaction. Methods used may include: • Identifying potential customers • Customer surveys • Customer feedback • Customer requests for product changes • Market research • Analysis of competitive products • Benchmarking 5.3 Quality Policy 5.3.1 <Business Unit> quality policy <Business Unit> is committed to continuous quality improvement of our products, processes, and people. Quality is integrated into all aspects of our business and forms the foundation of customer satisfaction. 5.3.2 <Company> mission and quality value statements <Business Unit>’s quality policy is the driver for the quality system. It is linked to <Business Unit>’s vision, mission, and values. Together they support <Company>’s mission statement: Do a great job for our customers, employees and stockholders by being the preeminent building block supplier to the worldwide Internet economy. <Business Unit>’s quality policy, vision, mission, and values are aligned with <Company>’s value statement on quality: We strive to: • Achieve the highest standards of excellence • Do the right things right • Continuously learn, develop and improve • Take pride in our work
  • 14. DOCUMENT NUMBER: 99-9999 PAGE 14 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 5.3.3 Communicating the <Business Unit> quality management system to employees <Business Unit>’s quality policy, vision, mission, and values, as well as <Company>’s mission and quality value, are communicated throughout the organization by: • Key personnel who are responsible for implementing <Business Unit>’s quality management system. • Using various media, including distribution of controlled documents, the <Business Unit> newsletter, bulletin board postings, badge cards, monthly update meetings (MUMs), quality-related training, team briefings, and the <Company> intranet. 5.4 Planning 5.4.1 Quality objectives <Business Unit> management staff establishes measurable quality objectives and related requirements that are consistent with <Business Unit>’s quality policy and communicates them to relevant functions and levels within the organization using, among other instruments: • <Business Unit> Agenda. The annual <Business Unit> Agenda lists objectives pertaining to the general quality system and continual improvement. • Management by Planning (MBP). MBP objectives include objectives for increasing organizational effectiveness, productivity, and employee satisfaction. Other quality objectives include those for product and improving products and processes. Together, these quality objectives drive the quality management system planning process. 5.4.2 Quality management system planning <Business Unit> management staff identifies and plans processes and resources required for the quality system and for achieving quality objectives. Elements in the overall quality management system planning process include: • Planning for the achievement of quality objectives and general quality system planning, the results of which are manifested in <Business Unit>’s quality manual. • Planning of product realization processes and product verification and validation activities. • Design and development planning. • Planning of monitoring and measurement of products, capability of processes, achievement of project objectives, and customer satisfaction. • Planning for continual improvement. Quality planning also ensures that adequate and appropriate resources are identified and implemented throughout the organization.
  • 15. DOCUMENT NUMBER: 99-9999 PAGE 15 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY The output of the quality management system planning process is documented in quality records. Any changes that are introduced into the quality management system are conducted in a controlled manner in order to maintain the integrity of the system. 5.5 Responsibility, Authority, and Communication 5.5.1 <Business Unit> quality management structure <Business Unit> management staff is responsible for defining, implementing, and maintaining the <Business Unit> quality system. This responsibility is delegated through the organization using structured lines of authority (see organizational chart). The structure: • Integrates all activities that affect the quality of <Business Unit> processes and products into a single system. • Facilitates reliable and continuous control over those activities. • Ensures that appropriate communication processes are established and that communication takes place regarding the effectiveness of the quality management system.
  • 16. DOCUMENT NUMBER: 99-9999 PAGE 16 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Important: Departments identified in shaded boxes fall outside the scope of <Business Unit>’s ISO registration. Departments connecting to the <Business Unit> organization using dashed lines are outside <Business Unit> but provide support functions. Finance Director, <Business Unit> Organizational Effectiveness Programs (OEP) Assembly Technology Architecture and Pathfinding Module Engineering Factory Operations Roadmap and Business Process Management (RBPM) Platform, Materials, and Enabling Development (PMED) Automation Non-CPU Packaging Design Process Development (DPD) Human Resources Quality and Reliability (Q&R) Quality and Reliability Engineering Support 5.5.2 Deployment responsibilities of management <Business Unit> management staff acknowledges its responsibility for deploying <Business Unit>’s quality management system throughout the organization by: • Defining and documenting <Business Unit>’s quality policy and quality objectives, and ensuring that they are communicated and understood within the organization. • Appointing a management representative with authority to ensure that the quality management system is effectively implemented and maintained. • Establishing work roles and responsibilities. • Regularly reviewing the status and adequacy of <Business Unit>’s quality management system. • Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.
  • 17. DOCUMENT NUMBER: 99-9999 PAGE 17 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY <Business Unit> management staff gives personnel performing quality functions sufficient responsibility and authority to: • Identify and record problems relating to <Business Unit>’s deliverables. • Initiate action to prevent the occurrence of nonconformities relating to <Business Unit>’s products, processes, and quality system. • Initiate, recommend, or provide solutions through designated channels. • Verify the implementation of solutions. • Control further processing, delivery, or installation of nonconforming product until the deficiency or the unsatisfactory condition has been corrected.
  • 18. DOCUMENT NUMBER: 99-9999 PAGE 18 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 5.5.3 Personnel responsible for quality implementation The responsibility, authority, and interrelationship of all personnel who manage, perform, and verify work are defined by procedures within the various departments and functional work groups, in organizational charts, and in Appendix 10.1, Key Organizational Responsibilities. The responsibilities for the <Business Unit> Director and the <Business Unit> ISO Management Representative appear in the table below. This person . . . is responsible and accountable for . . . <Business Unit> Director • Overall management of the business, including <Business Unit>’s quality management system as defined in <Business Unit>’s quality manual. <Business Unit> ISO Management Representative • Reviewing <Business Unit>’s quality management system and reporting the findings to management staff. • Maintaining the effectiveness of <Business Unit>’s quality management system by adapting it to fit changing circumstances. • Ensuring that functional work groups are proactive when probable instances of nonconformity exist. • Reporting to <Business Unit> management staff if resources are inadequate for maintaining an effective internal quality audit program. • Maintaining contact with the Registering Authority. • Providing <Business Unit> management staff with updates on the findings of quality audits and assessments and with progress reports on plans for corrective action that result from the findings of these audits and assessments. • Ensuring the promotion of awareness of customer requirements throughout the organization. • Performing the duties of a management representative as defined in ISO 9001:2000. 5.6 Management Review 5.6.1 Frequency <Business Unit> management staff periodically review the <Business Unit> quality management system to ensure its continuing suitability, adequacy, and effectiveness. The reviews assess opportunities for improvement and the need to incorporate improvements in <Business Unit>’s quality management system, including changing <Business Unit>’s quality policy and quality objectives. The review occurs at least once a year but may occur more often based on the performance of the quality management system and business needs.
  • 19. DOCUMENT NUMBER: 99-9999 PAGE 19 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 5.6.2 Review items Review items at any one meeting vary depending on importance, frequency of meetings, and whether the meetings are attended by <Business Unit> management staff or by another appropriate level of management. <Business Unit> management staff use these meetings to address, over the course of a year, the following performance and improvement opportunities: • Results of audits • Customer feedback • Process performance and product conformity • Status of preventive and corrective action • Follow-up actions from previous management reviews • Planned changes that could affect the quality management system • Recommendations for improvement 5.6.3 Review outcome The outcome of a review includes actions related to: • Improvement of the effectiveness of the quality management system and its processes. • Improvement of deliverables related to requirements. • Resource needs. Results of the reviews are recorded and required actions (ARs) are assigned to responsible parties for follow-up actions. The status of ARs is tracked to ensure successful and timely completion. 6 Resource Management <Business Unit> determines and provides the resources needed to: • Implement and maintain the quality management system and continually improve its effectiveness. • Enhance customer satisfaction. 6.1 Assignment of Personnel Personnel performing work affecting <Business Unit> deliverables are deemed competent on the basis of their appropriate education, skills, experience, and training. Appropriate departments and functional work groups maintain records documenting employees’ competencies..
  • 20. DOCUMENT NUMBER: 99-9999 PAGE 20 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 6.2 Competence, Awareness, and Training 6.2.1 Commitment to training <Business Unit> management staff is committed to employee training as a way of ensuring that personnel: • Have the knowledge, skills, tools, and techniques required to perform their jobs and initiate improvements and innovations. • Understand the potential consequences of not following procedures. • Are aware of the relevance and importance of their activities and how they contribute to the achievement of <Business Unit>’s quality objectives. This commitment to training extends to newly recruited personnel and personnel transferred to new assignments. 6.2.2 Identifying competency needs and developing training schedules Each functional work group is responsible for: • Determining the necessary competence for personnel performing work affecting deliverables by analyzing job requirements and an individual’s current qualifications and career development goals. • Developing and regularly reviewing training plans and schedules. • Arranging training or taking other actions to satisfy competency needs of personnel. • Ensuring that training or other actions continue to be appropriate throughout an individual’s tenure in the work group. 6.2.3 Technical training and evaluation A technical training group coordinates and facilitates the instruction of <Business Unit> personnel who require additional technical skills as required by <Business Unit> business and training needs. Training may occur on the job, in a formal classroom setting, or off-site at a customer’s or supplier’s facility. The training group regularly evaluates training activities to ensure that they are fulfilling the requirements of personnel and the needs of <Business Unit>. Individual functional groups also evaluate their training needs. These needs may change because: • An employee is reassigned, promoted, or assumes additional responsibilities. • A new employee is hired. • Customer requirements change. • A new structure, system, process, or procedure is implemented. • A specific performance problem is identified.
  • 21. DOCUMENT NUMBER: 99-9999 PAGE 21 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 6.2.4 Training records Personnel competency needs are documented in departmental and/or individual employee training plans. Qualified trainers and facilitators carry out the training. Records of an individual’s training and qualifications (including copies of licenses and certifications, as appropriate) are maintained. 6.3 Infrastructure <Company> provides the infrastructure <Business Unit> needs to achieve conformity to requirements for deliverables, including: • Buildings, workspace, and associated utilities. • Process equipment, both hardware and software. • Supporting services, such as transport facilities and information and communication technology. Southwest Regional Site Materials and Services (SMS) provisions and maintains buildings, workspace, and associated utilities. Specifically SMS: • Installs, qualifies, operates, and maintains process support facilities. • Monitors the performance of facilities support equipment associated with product manufacturing. • Provides preventive and corrective maintenance of facilities support and monitoring equipment. 6.4 Work Environment <Business Unit> management staff, with support from <Company> Site Environmental, Health, and Safety (EHS), is committed to providing a suitable work environment. The following human factors affect the work environment: • Creative work methodologies, such as telecommuting • Opportunities for professional and personal development through programs such as ERSA (Employee Relations Self-Assessment) • Opportunities for greater involvement within <Business Unit> and outside in the community through programs such as <Company>’s It’s a Great Place to Work • Ergonomics • Workplace location • Safety rules and guidance • Use of protective equipment
  • 22. DOCUMENT NUMBER: 99-9999 PAGE 22 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY The following physical factors affect the work environment: • Cleanliness • Hazardous substances and situations • Air flow, temperature, humidity, and pollution • Lighting • Noise and vibration 7 Product Realization <Business Unit>’s manufacturing packaging technology development consists of five phases, associated activities, and “Rev” (Revision) levels: • Path Finding. Assembly and test and silicon technology optimization begins during this phase. Silicon and packaging technology roadmaps are synchronized, and the strategic assembly technology direction is determined. The Technology Architecture Plan (TAP) is published. • Definition. The packaging technology envelope is defined and aligned with business and product needs during this phase. The product is formally added to the <Business Unit> roadmap, and the product Package Design Requirements Document (PDRD) is initiated. Among the controlled documents that are released are the Product Division’s Package Product Requirements Document (PRD); the initial Technology Target Specification (TTS), which defines the requirements for a package technology; the initial design rules; and the initial Technology Performance Specifications (TPSs). • Discovery. The assembly and test process, materials, piece-parts, and equipment are designed to satisfy the packaging technology envelope, lead product requirements, and design rules during this phase. A Plan of Record (POR) baseline process is established. • Development. The baseline process is defined. During this phase, the focus is on manufacturing stability and capability and the analysis of data related to manufacturability, yield, and reliability, as well as EHS (environmental, health, and safety) data related to equipment, materials, and waste streams. Process specifications are written and change control is implemented. • Deployment. Revenue product begins to ship and the factory ramps to high-volume manufacturing during this phase, which is normally defined as the period from Technical Certification to Factory Certification or High-Volume Manufacturing (HVM) Certification. (When Simultaneous Technical Certification [STC] methodology is employed, Technical Certification and HVM Certification occur simultaneously.) Continual focus is on yield and manufacturability improvements. The Development Manufacturing Line transfers the process to the production factory.
  • 23. DOCUMENT NUMBER: 99-9999 PAGE 23 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY The following figure represents the five phases of <Business Unit>’s manufacturing packaging technology development that are described in the preceding paragraphs. The figure also defines the scope of <Business Unit>’s ISO 9001:2000 certification. The scope starts with the initial publication of the Technology Target Specification and ends with High-Volume Manufacturing Certification, when the packaging process has been duplicated in the receiving factory and the factory assumes responsibility for running and sustaining the process. Path- Finding Definition Discovery Development Deployment Technology Target Specification High-Volume Manufacturing Certification Technology Certification Plan of Recordand Non- CPU Scope of ISO Certification 7.1 Planning of Product Realization 7.1.1 Creating product-specific quality plans <Business Unit> creates product-specific quality plans for product realization processes and for product verification and validation activities. These plans are consistent with the other requirements of <Business Unit>’s quality management system. In creating product-specific quality plans, <Business Unit> determines: • Quality objectives and requirements for the deliverable. • The need to establish processes, documents, and provide resources specific to the deliverable. • Required verification, validation, monitoring, inspection, and test activities specific to the deliverable. • Product acceptance criteria. • Records needed to provide evidence that the realization processes and resulting deliverable fulfill requirements. 7.1.2 Quality plan documentation <Business Unit> documents its plans for realization processes and for verification and validation activities in product drawings and specifications, material or process flow diagrams, process flowcharts, setup sheets, verification and validation reports, work orders, lot travelers, inspection and test procedures, and similar documents that define the manner of production and specify the inspection and test programs for given products. Collectively, these documents comprise the product-specific quality plan.
  • 24. DOCUMENT NUMBER: 99-9999 PAGE 24 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 7.2 Customer-Related Processes 7.2.1 Determination of requirements related to deliverables <Business Unit> does not identify requirements initiated by external customers; rather, a corporate organization determines them in accordance with documented procedures. The procedures ensure that the following items are determined: • Requirements specified by the customer, including requirements for delivery. If customer requirements differ from standard <Company> products, a corporate mediator resolves the differences. • Requirements and technologies not stated by the customer but necessary for specified use or application. • Statutory and regulatory requirements related to the product. • Any additional requirements determined by corporate. These requirements are communicated to <Company> divisions, fabrication sites, and subsequently <Business Unit>. Requirements may also be initiated by internal customers who want to have <Business Unit>’s processes applied to their design concepts. Design concepts are systematically analyzed to identify customer requirements. 7.2.2 Review of requirements related to deliverables <Business Unit> reviews requirements related to deliverables prior to the commitment to supply deliverables to customers. The review process ensures that: • Product and technology requirements are understood. • Requirements differing from those previously expressed are resolved. • Requirements are confirmed before acceptance. • <Business Unit> can meet the defined requirements. Review results and action items are maintained. Requirements for deliverables are defined in terms of frequency, power, die size, device speed, volumes, delivery dates, and other factors. They are communicated to responsible departments and functional work groups within <Business Unit> using various methods, including: • Technology Target Specifications • Module Target Specifications (MTSs) • Design rules • Technology Performance Specifications (TPSs) • Equipment specifications • Material specifications
  • 25. DOCUMENT NUMBER: 99-9999 PAGE 25 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY • Package Design Requirements Documents (PDRDs) • Bills of Materials (BOMs) • Plan It • Meeting minutes • Scientific record books When requirements for deliverables change, <Business Unit> ensures that the relevant documents are amended and that relevant personnel are made aware of the changes. 7.2.3 Customer communication <Business Unit> has implemented effective processes for communicating with its customers. These customers may be other <Company> organizations. Communications include, but are not limited to, the following: • Product information • Inquiries • Order handling • Customer feedback 7.3 Design and Development 7.3.1 Design and development planning <Business Unit> plans and controls design and development of its products. Planning activities determine: • Design and development stages. • Review, verification, and validation that are appropriate to each design and development stage. • Responsibilities and authorities for design and development. <Business Unit> manages interfaces between different groups involved in design and development to ensure effective communication. Planning output is updated as the design and development progresses. 7.3.2 Design and development inputs <Business Unit> ensures that inputs relating to requirements for deliverables are determined and records maintained. Inputs may include: • Functional and performance requirements. • Applicable statutory and regulatory requirements. • Where applicable, information derived from previous similar designs. • Other requirements essential for design and development. Qualified personnel review the requirements for adequacy and completeness and resolve any issues.
  • 26. DOCUMENT NUMBER: 99-9999 PAGE 26 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 7.3.3 Design and development outputs <Business Unit> ensures that the outputs of design and development are in a format suitable to manufacturing and capable of verification against design and development input. These outputs generally consist of: • PDRDs • Design rules • iTech files • Design library • Vendor Design Approval (VDA) • SPEED BOM specification • Netlist/pin map The outputs of design and development (baseline) are approved prior to release to ensure that they: • Meet input requirements for design and development. • Provide appropriate information for purchasing and production operations. • Contain or reference product acceptance criteria. • Specify the characteristics of the product that are essential for its safe and proper use. 7.3.4 Design and development review At suitable stages, individuals involved with product design and development meet to: • Evaluate the ability of the results of design and development to fulfill requirements. • Identify any problems and propose necessary actions. Review results and action items are maintained. 7.3.5 Design and development verification Design and development verification is the process by which individuals involved with design and development demonstrate that outputs have satisfied the design and development input requirements. Verification provides a preliminary assessment of the package’s manufacturability. <Business Unit> has documented procedures that establish the points at which verification activities are performed. Verification records and action items are maintained. 7.3.6 Design and development validation Design and development validation is the process by which individuals involved with product design and development demonstrate that the resulting product is capable of fulfilling the requirements for the specified use or application.
  • 27. DOCUMENT NUMBER: 99-9999 PAGE 27 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY <Business Unit> has documented procedures that establish when in the design and development process validation is performed. Validation records and action items are maintained. 7.3.7 Control of design and development changes Authorized <Business Unit> personnel identify, document, review, and approve all design and development changes before implementation. Records of the results of the change review and action items are maintained. 7.4 Purchasing Purchases and services that impact the quality of products delivered to <Business Unit> customers are strictly controlled. The type and extent of control applied to the supplier and the purchased product are dependent on the effect of the purchased product on subsequent product realization or the final product. Controls are exercised by departments inside and outside <Business Unit> depending on the purchased product or service. 7.4.1 Purchasing process <Business Unit> controls its purchasing processes to ensure that direct and indirect materials: • Conform to requirements. • Reach manufacturing without interruption. • Are procured from approved suppliers. The responsible commodity management team evaluates and selects suppliers on the basis of their ability to meet <Business Unit>’s requirements, including, as applicable, having a quality management system and meeting any stated product- or service-specific quality assurance requirements. The responsible commodity team performs subsequent reevaluations at prescribed intervals using methods including, but not limited to, those in the following list: • A formal assessment process of the supplier’s capability to supply products and/or services. • Analysis of data in relation to key parameters; for example, delivery performance and material rejects • Feedback received. • Evaluation at the time of subcontract renewal. Evaluation records and action items arising from the evaluation are maintained.
  • 28. DOCUMENT NUMBER: 99-9999 PAGE 28 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 7.4.2 Purchasing information <Business Unit> ensures that its purchasing documents are approved prior to submitting them to the supplier. During the approval process, information relating to the particular purchase is checked for accuracy and adequacy of the specified requirements. Purchasing information may include: • Drawings. • Specifications. • References to part numbers and descriptions. • Requirements for approval of product, procedures, processes, and equipment. • Requirements for qualification of personnel. • Verification arrangements at the supplier’s premises and method of product release. • Supplier quality management system requirements. <Business Unit> maintains records of all its purchasing documents. 7.4.3 Verification of purchased product <Business Unit> has established and implemented inspection and other activities necessary for ensuring that purchased product meets specified purchase requirements. When the applicable contract with the supplier allows, <Business Unit>’s representatives may audit the supplier’s premises. Also, when specified under contract and allowable under the contract with <Business Unit>’s suppliers, <Business Unit>’s customers or their representatives will be afforded the opportunity to visit the supplier’s premises to perform verification. 7.5 Production Provision 7.5.1 Control of production operations <Business Unit> plans and carries out production operations under controlled conditions. Controlled conditions include, as applicable: • Availability of information that describes the characteristics of the product. • Availability of work instructions at points of use. • Use of suitable equipment. • Availability and use of measuring and monitoring devices. • Implementation of monitoring and measurement activities. • Implementation of release, delivery, and any applicable post-delivery activities. 7.5.1.1 Control of processes and equipment The processes and equipment used to produce new package technology are initially qualified under controlled conditions. Platform managers define the transfer requirements for high-volume manufacturing.
  • 29. DOCUMENT NUMBER: 99-9999 PAGE 29 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY The methods used to qualify equipment purchased to support increasing product demand are described in procurement specifications and/or contracts. Additional equipment characterization requirements are defined in Change Control Board (CCB) documents. 7.5.1.2 Process sequence and recipes The procedures and recipes for each process step are documented in controlled documents, which typically include the following: • Individual process operating specifications • Bills of materials (BOMs) • Basic product specifications (BPSs) • Special customer specifications (S-specs) • Online Summary of Electrical Test (OSET) The correct production sequences are controlled and planned using WorkStream. Information contained in WorkStream includes the product routes, operation numbers, processing data, and other information necessary to support the manufacturing process. The progress of a product or group of products through a production route is controlled and monitored in WorkStream. WorkStream is accessible using computer terminals located throughout the factory. 7.5.1.3 Process change control/process improvement Changes to continually improve qualified processes, testing, equipment, or indirect and direct materials are documented and controlled by the appropriate CCB. To maintain the integrity of the process, <Business Unit> verifies the resulting output to ensure that the instituted change has the desired effect. 7.5.1.4 Statistical process control Where appropriate, statistical process control (SPC) is used on key process parameters and quality characteristics. Response flow checklists (RFCs) to correct out-of-control conditions are used where appropriate. The details of the SPC system and other monitors are documented in individual process specifications. 7.5.2 Validation of processes for production Validation of processes for production demonstrates the ability of processes to achieve planned results. At appropriate intervals in the realization process, <Business Unit> validates processes where: • Subsequent monitoring or measurement cannot verify the resulting output. • Deficiencies in the product may become apparent only after the product is in use.
  • 30. DOCUMENT NUMBER: 99-9999 PAGE 30 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY <Business Unit> validation arrangements of these processes include, as applicable: • Defined criteria for review and approval of the processes. • Approval of equipment and qualification of personnel. • Use of specific methods and procedures. • Records requirements. • Revalidation. 7.5.3 Identification and traceability <Business Unit> identifies, where appropriate, the product by suitable means throughout product realization, and it identifies the product status with respect to monitoring and measurement requirements as described below. 7.5.3.1 Identification and traceability control <Business Unit> maintains product identification and traceability throughout product realization using a combination of the following methods: • Physical segregation • Fab lot number • Lot travelers (Assembly Test Process Orders [ATPOs] or Finish Process Orders [FPOs]) • WorkStream routes • Product package marking • Substrate Lot Identifiers (SLIs) The automated shop floor control system, WorkStream, controls product routing and traceability. WorkStream routes are programmed to prevent product from being moved to a future operation until all processing and data collection at the current operation are complete. This control process applies to production lots; nonstandard flow products, which are processed using specialized routes; and die sales, which are normal product processed through a partial assembly route in accordance with customer request. WorkStream can be used to trace lots currently in the factory to a specific location or operation in the factory. Records pertaining to lot processing (ATPO/FPO) are retained. Production lots are physically segregated from each other through the use of approved carts. A lot is carried on a designated cart (or carts), and the cart carries only one lot to maintain traceability and lot integrity. 7.5.3.2 Monitoring and measurement status Lot travelers (ATPOs and FPOs) and WorkStream are used to indicate the status of product within the overall process flow. Manufacturing personnel record the measurement and monitoring status of each lot on the appropriate traveler and enter the data into WorkStream.
  • 31. DOCUMENT NUMBER: 99-9999 PAGE 31 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Product that has been inspected and has passed the defined quality criteria is moved to the next operation. Rejected product is physically separated from acceptable product whenever possible. If physical separation is not yet possible, the rejected product is clearly identified as reject product and disposed of according to the governing procedure. Product that has been placed on hold for production-related problems is identified as “on hold” and cannot be processed further until its disposition is determined. 7.5.4 Customer property <Business Unit> identifies, verifies, and protects property and other assets owned by customers and other interested parties while the property is under its control. Such property may be provided for use or incorporation into an <Business Unit> deliverable. Property that is lost, damaged, or does not meet specification is reported to the customer and records are maintained. 7.5.5 Preservation of product <Business Unit> has processes that preserve conformity of product and constituent product parts during internal processing and delivery to the intended destination. <Business Unit> personnel are responsible for handling product inside the factory and for delivery to the Arizona Distribution Center (ADC). ADC is responsible for packaging and handling of finished product. Southwest Regional Site Materials and Services monitors direct materials from point of receipt through storage until it is issued to <Business Unit> manufacturing. Supplier packaging is maintained as long as possible to ensure proper handling and storage. Perishable material is coded with expiration dates. Indirect materials are coded with part numbers and revision levels to ensure that correct revision level materials are being used in manufacturing. <Business Unit> product is assembled under appropriate environmental control to prevent contamination, deterioration, and damage from electrostatic discharge. Use of automated process equipment and associated carriers minimizes the potential for damage due to material handling. <Business Unit> packaging and shipping standards conform to corporate drawing specifications. Packaging supplies are procured through corporate-contracted suppliers. 7.6 Control of Monitoring and Measuring Devices 7.6.1 Introduction <Business Unit>’s processes ensure that monitoring and measurement activities are carried out in a manner that is consistent with monitoring and measurement requirements. <Business Unit> controls, calibrates, and maintains monitoring and measuring devices needed to provide evidence of conformity of product to determined
  • 32. DOCUMENT NUMBER: 99-9999 PAGE 32 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY requirements. Manufacturing and support organizations deliver to the Site Calibration Standards Lab measuring equipment that either needs adjustment or is due for calibration on or before the calibration due date. Every organization that comes into contact with measuring equipment has procedures to protect the equipment from damage and deterioration during handling, maintenance, and storage. Monitoring and measuring devices subject to calibration include, but are not limited to: • Measurement and test equipment (M&TE). • Analytical in-process inspection equipment. • Final test equipment. • Computer software used in the monitoring and measurement of specified requirements. <Business Unit> preventive maintenance and calibration procedures also apply to monitoring and measuring devices used by suppliers in the Supplier Support Program (SSP) and by other contractors who actively support the factory. 7.6.2 Calibration safeguards, identification, status, and records <Business Unit> safeguards measuring equipment from adjustments that would invalidate measurement results. Measuring equipment subject to calibration control is uniquely identified. Calibration frequency is documented and controlled by the Calibration Scheduling System or other appropriate system. Records and results of calibration and maintenance performed on each piece of equipment are maintained as specified by the supporting group and factory requirements. Calibration status appears on a sticker or label affixed to the equipment or in a readily accessible database or record. 7.6.3 Calibration methods When performing calibration, qualified <Business Unit> personnel use procedures that identify the measurements to be made, the accuracies required, and the calibration settings. The measuring equipment used is capable of the precision and accuracy requirements, and the uncertainty of each measurement within specified limits. Measuring equipment is calibrated or verified at specified intervals or prior to use, as applicable, against measurement standards traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration or verification is recorded. 7.6.4 Corrective action <Business Unit> initiates appropriate action if measuring equipment is found to be out of tolerance or in an overdue condition. Appropriate action may include, but is not limited to, frequency, validity, and product risk reviews as described below. Records of the results of action taken are maintained and reviewed.
  • 33. DOCUMENT NUMBER: 99-9999 PAGE 33 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 7.6.4.1 Out-of-tolerance equipment for user/owner and calibrating departments When measuring equipment is found in an out-of-tolerance condition, the using department is notified. The notification includes, but is not be limited to, all associated measurement data. Departments notified of an out-of-tolerance device evaluate the impact and possible acceptance of nonconforming product or services by performing a Disposition Review Board (DRB). The Quality Systems Engineer generates the DRB in SPEED. Important: No DRB is required if an out-of-tolerance condition occurs during initial (first) equipment calibration performed by the Site Calibration Standards Lab. 7.6.4.2 Overdue equipment for user/owner and calibrating departments When measuring equipment is found in an overdue condition, the using department is notified. The notification includes, but is not limited to, all associated scheduling data. Departments notified of an overdue device evaluate the impact by performing a Process Trouble Report (PTR). The Quality Systems Engineer generates the PTR in SPEED. 8 Measurement, Analysis, and Improvement 8.1 Planning Monitoring, Measurement, and Improvement Activities <Business Unit> plans and implements the monitoring, measurement, analysis, and improvement processes needed to: • Demonstrate conformity of processes and product. • Ensure conformity of the quality management system. • Continually improve the effectiveness of the quality management system. <Business Unit> establishes the applicable methods, including statistical techniques and the specific equipment used for measuring processes and products.
  • 34. DOCUMENT NUMBER: 99-9999 PAGE 34 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 8.2 Monitoring and Measurement 8.2.1 Customer satisfaction <Business Unit> gathers, analyzes, and monitors information relating to customer perception of <Business Unit>’s performance. <Business Unit> uses the sources of customer satisfaction information to determine if the organization is meeting the needs and expectations of <Business Unit>’s customers. Results are reported to the <Business Unit> management staff as part of the management review process, and records and action items are maintained. 8.2.2 Internal and external audits <Business Unit> conducts internal audits at planned intervals in all areas of the organization where the quality of deliverables to the customer is affected. <Business Unit> also facilitates second-party audits from Corporate Quality Assessment and third-party audits from the Registering Authority. These audits: • Verify compliance of the quality management system to product realization plans, the requirements of ISO 9001:2000 and internal specifications, as appropriate, and the quality management system requirements established by <Business Unit>. • Determine whether the quality management system has been effectively implemented and maintained. • Help drive continual improvement throughout <Business Unit>. 8.2.2.1 Quality audit implementation Quality system audits are the defined responsibility of the Quality Systems Department. Audits are: • Carried out annually or as needed in line with documented procedures and responsibilities. Audit frequency is based on business needs and/or maturity system. • Performed in a manner that ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. • Defined, planned, and scheduled on the basis of the status and importance of the activities and areas to be audited, as well as on the results of previous audits. In addition to internal audits, the manufacturing floor performs self-audits annually or as needed. 8.2.2.2 Audit results, follow-up, and records The results of audits are formally recorded, along with timely corrective/preventive action and the time frame agreed on by personnel having responsibility in the areas audited. The effectiveness of the corrective/prevention action is reviewed as needed with personnel independent from the audited areas either during a subsequently scheduled audit or randomly.
  • 35. DOCUMENT NUMBER: 99-9999 PAGE 35 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY The status and effectiveness of corrective and preventive actions, as well as audit results and trends, are assessed and reviewed as part of the management review process. 8.2.2.3 Continual improvement Audit and assessment results are analyzed to identify root causes of problems. Organization-wide issues are identified and presented to management. The approach ensures the continual improvement of the quality management system, while it mitigates the recurrence of problems and nonconformities. 8.2.3 Monitoring and measurement of processes At pertinent stages of the realization process, <Business Unit> monitors and, where applicable, measures the performance of its processes. Records and action items are maintained. Measures of process performance that may be incorporated into various realization processes include the following indicators: • Capability • Cost allocation and reduction • Cycle time or throughput • Measurable aspects of dependability • Yield • Effectiveness and efficiency of people • Reaction time • Utilization of technologies • Waste reduction 8.2.4 Monitoring and measurement of deliverables At pertinent stages of the realization process, <Business Unit> monitors and, where applicable, measures product characteristics. Verification (inspection) records and the test history of each production lot are maintained in WorkStream. Records are also maintained as specified by the relevant documentation, including the name of the person authorizing release of the deliverable. 8.3 Control of Nonconforming Product <Business Unit> ensures that nonconforming product is identified and controlled to prevent its unintended use or delivery. Nonconforming data are collected and analyzed, and records and action items are maintained. 8.3.1 Disposition Review Board A DRB is convened to confirm that questionable product is normal or indistinguishable from normal and to determine the disposition of such product. A
  • 36. DOCUMENT NUMBER: 99-9999 PAGE 36 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY DRB is required when routine dispositioning procedures do not specify the appropriate disposition. 8.3.2 Material Review Board A Material Review Board (MRB) is convened to evaluate the shipment of nonconforming product. Nonconforming product is shipped only with the consent of a Quality and Reliability (Q&R) engineer, the customer, and/or Product Division. 8.4 Analysis of Data <Business Unit> identifies, collects, and analyzes appropriate data to: • Demonstrate the effectiveness of the quality management system. • Evaluate improvement and performance opportunities. 8.5 Improvement 8.5.1 Continual improvement <Business Unit> plans and manages the processes necessary for the continual improvement of its quality management system. 8.5.2 Corrective and preventive actions <Business Unit> documents and follows processes that review nonconforming product and evaluates the need for correction and preventive actions. The results of corrective and preventive actions taken are recorded and reviewed. Examples of <Business Unit> processes that may initiate corrective and preventive actions are: • Management review of quality systems • Internal and external audits and self-audits • Incoming material quality control inspections • Dispositioning of nonconforming product, including DRBs and MRBs • Yield review and low-yield analysis • Customer feedback, including Functional Analysis Correlation Requests (FACRs) • External Administrative Customers Issues (EACIs) • Customer Quality Incident Report (CQIR) 8.5.3 Customer feedback system <Business Unit> sometimes receives feedback from <Company>’s customers (through the <Company> Quality Support Center) in the form of FACRs and EACIs. <Company>’s Customer Quality Engineers may raise awareness of certain high-impact issues by generating a CQIR.
  • 37. DOCUMENT NUMBER: 99-9999 PAGE 37 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 8.5.4 Corrective action tracking The coordinator/owner for each process that is part of the formal corrective/- preventive action system is responsible for tracking corrective and preventive actions. 8.5.5 Corrective/preventive action implementation Implementation of corrective and preventive actions is prioritized as necessary based on factory requirements and customer expectations. Corrective and preventive actions that require process changes are reviewed and approved for implementation by the appropriate Process Change Control Board (PCCB). The results of actions taken are recorded. 8.5.6 Corrective/preventive action escalation Any issues identified within the formal corrective/preventive action system that require escalation due to priority, risk, or resourcing may be escalated using any of the following people or systems: • Platform manager • Department manager • Manufacturing shift manager • Quality and Reliability Manager • ISO Management Representative • Management review process • Other communication forums as appropriate 9 Revision History Rev. Date Description Initiator 08 10/12/98 Renew spec without content changes. <Name> 09 2/5/99 Complete rewrite, reformat to comply with governing spec 7-section formatting. <Name> 10 4/2/99 CN – To comply with ISO audit finding in development of a more robust and closed loop system for dealing with out-of-tolerance and overdue measurement and test equipment that require calibration from the site(s) Standard Calibration Lab. <Name> 11 5/26/99 CN – Clarify when a DRB should not occur. <Name> 12 02/14/00 CN – Rewrite. <Name> 13 10/13/00 Complete rewrite using new template to comply with ISO 9001:2000 <Name>
  • 38. DOCUMENT NUMBER: 99-9999 PAGE 38 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 10 Appendices 10.1 Key Organizational Responsibilities The responsibility, authority, and interrelationship of all personnel who manage, perform, and verify work are defined in organizational charts, by procedures within the various organizations, focus areas, and functional work groups, and in the following matrix: Important: • Refer to 5.5.3 for a description of the responsibilities assigned to the <Business Unit> Director and the <Business Unit> ISO Management Representative. • Organizations and focus areas in rows bordered by dashed lines are outside <Business Unit> but provide specified support functions. Organization Focus Areas Roadmap and Business Process Management (RBPM) • Product and Technology Integration • CPU Packaging and Enabling Roadmaps • Technology Assessments and Communications • Package Technology Management and Capability Roadmaps Design Process Development (DPD) • Design Tool Development • Thermal/Mechanical Tools and Analysis • Electrical Modeling and Analysis • Mechanical Design and Integration • Package Design and Integration • Design Processes Platform, Materials and Enabling Development (PMED) • Platform Integration • Materials • Enabling • Substrate Assembly Subcontractors Module Engineering • Process Engineering • Process Change Control Board
  • 39. DOCUMENT NUMBER: 99-9999 PAGE 39 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Organization Focus Areas Automation • Equipment Integration • Engineering Analysis • Shop Floor Control • Infrastructure • Planning and Logistics Group (PLG) • Test Automation • Change Requests • Change Control Board • MDT • Operations Factory Operations • Manufacturing • Manufacturing Systems • Industrial Engineering • Build Logistics Organizational Effectiveness Programs • Organizational Development • Salaried Non-Exempt/Exempt/First Line Management (FLM) Development • Mentoring • Embedded Staffing and Sourcing • Statistical Applications • Factory Support • Peer Training Systems • Business Practices • Safety • Employee Relations Self-Assessment (ERSA) • Quality Systems Audit • Document Management Information Services • Learning Technologies Integration and Validation Quality and Reliability (Q&R) • Platform and Enabling Quality and Reliability Engineering (QRE) • Materials Analysis • Failure Analysis • Fault Isolation • Product QRE • Customer and Sustaining Engineering Quality and Reliability Engineering Support • Product reliability stress • Preventive maintenance and calibration of equipment and tools
  • 40. DOCUMENT NUMBER: 99-9999 PAGE 40 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Organization Focus Areas Product Engineering • Product sample and early revenue requirements management • Primary interface to Product Division • Division to Virtual Factory coordination • Product silicon test software (Test Change Control Board, Component test, Burn-in, PC Platform Validation) Southwest Regional Site Materials and Services (SMS) • Process support facilities • Facilities support equipment • Preventive and corrective maintenance of facilities support and monitoring equipment
  • 41. DOCUMENT NUMBER: 99-9999 PAGE 41 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 10 Appendices 10.2 ISO 9001:2000/<Business Unit> Quality Manual Matrix ISO Clause <Business Unit> Quality Manual Section ∗∗∗∗ 1.2 Application .............................................................. 4.2.1, 5.5.1, 7 4 Quality management system ............................................. 1 4.1 General requirements .............................................. 1 4.2 Documentation requirements .................................. 4.3 4.2.1 General ........................................................ 4.3 4.2.2 Quality manual ............................................ 4.3, 4.4 4.2.3 Control of documents .................................. 4.3.2, 4.4, 4.5, 4.6 4.2.4 Control of quality records ............................ 3, 4.3.3, 4.4.4, 4.5, 4.6, 5.6.3, 6.1, 6.2.4, 7.1.1, 7.2.2, 7.3.4, 7.3.5, 7.3.6, 7.3.7, 7.4.1, 7.4.2, 7.5.2, 7.6.2, 7.6.4, 8.2, 8.5.2, 8.5.5 5 Management responsibility .............................................. 5 5.1 Management commitment ....................................... 5.1, 5.5.3, 5.6, 6, 10.1 5.2 Customer focus ........................................................ 5.2, 7.2 5.3 Quality policy .......................................................... 5.3, 5.5.2, 5.6.1 5.4 Planning ................................................................... 5.4 5.4.1 Quality objectives ........................................ 5.4.1, 5.4.2 5.4.2 Quality management system planning ........ 4.6, 5.4.2, 6, 7.1, 7.3.1, 8.1, 8.5.1 5.5 Responsibility, authority and communication ......... 5.5 5.5.1 Responsibility and authority ........................ 5.3.1, 5.4.1, 5.5.1, 5.5.2, 5.5.3, 5.6, 10.1 5.5.2 Management representative ......................... 5.5.3 5.5.3 Internal communication ............................... 5.3.3, 5.5.3, 6.2, 10.1 5.6 Management review ................................................ 5.6 5.6.1 General ........................................................ 4.4.3, 5.4.2, 5.6.1 5.6.2 Review input ................................................ 5.6.2, 8.2.1, 8.2.2.2, 8.5.2, 8.5.6 ∗∗∗∗ Boldface = Strong relationship between the <Business Unit> Quality Manual and the ISO 9001:2000 clause.
  • 42. DOCUMENT NUMBER: 99-9999 PAGE 42 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY ISO Clause <Business Unit> Quality Manual Section ∗∗∗∗ 5.6.3 Review output .............................................. 5.6.3, 4.6 6 Resource management ..................................................... 6 6.1 Provision of resources ............................................. 5.1, 6 6.2 Human resources ..................................................... 6.1, 6.2 6.2.1 General ........................................................ 5.1, 6.1, 6.2 6.2.2 Competence, awareness and training .......... 4.6, 6.2 6.3 Infrastructure ........................................................... 6.3 6.4 Work environment .............................................. 6.4 7 Product realization ....................................................... 7 7.1 Planning of product realization ............................... 5.4.2, 4.6, 6, 7.1, 7.2.2, 7.3.3, 7.3.5, 7.3.6, 8.1 7.2 Customer-related processes ..................................... 7.2 7.2.1 Determination of requirements related to the product ................................................... 5.2, 7.2.1 7.2.2 Review of requirements related to the product ......................................................... 4.6, 7.2.2 7.2.3 Customer communication ............................ 7.2.3, 8.5.3 7.3 Design and development ......................................... 7.3 7.3.1 Design and development planning ............... 5.4.2, 7.3.1 7.3.2 Design and development inputs .................. 4.6, 7.3.2 7.3.3 Design and development outputs ................ 7.3.3, 7.5 7.3.4 Design and development review ................. 4.6, 7.3.4 7.3.5 Design and development verification .......... 4.6, 7.3.5 7.3.6 Design and development validation ............ 4.6, 7.3.6 7.3.7 Control of design and development changes ........................................................ 4.6, 7.3.7 7.4 Purchasing ............................................................... 7.4 7.4.1 Purchasing process ...................................... 4.6, 7.4.1, 8.4 7.4.2 Purchasing information ............................... 4.6, 7.4.2 7.4.3 Verification of purchased product ............... 7.4.3 7.5 Production and service provision ............................ 7.5
  • 43. DOCUMENT NUMBER: 99-9999 PAGE 43 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY ISO Clause <Business Unit> Quality Manual Section ∗∗∗∗ 7.5.1 Control of production and service provision ...................................................... 7.5.1 7.5.2 Validation of processes for production and service provision.................................... 4.6, 6.2.3, 7.5.2 7.5.3 Identification and traceability ...................... 4.6, 7.5.3, 8.3 7.5.4 Customer property ....................................... 7.5.4 7.5.5 Preservation of product ............................... 7.5.5 7.6 Control of monitoring and measuring devices ........ 4.6, 7.2.1, 7.6, 8.3 8 Measurement, analysis and improvement ........................ 8 8.1 General .................................................................... 5.4.2, 7.1, 8.1, 8.2 8.2 Monitoring and measurement .................................. 8.2 8.2.1 Customer satisfaction .................................. 5.6.2, 8.2.1, 8.5.3 8.2.2 Internal audit .............................................. 4.6, 5.6.2, 8.2.2, 8.4, 8.5.1 8.2.3 Monitoring and measurement of processes ...................................................... 4.6, 8.2.3, 8.4 8.2.4 Monitoring and measurement of product .... 4.6, 8.2.4, 8.3, 8.4 8.3 Control of nonconforming product .......................... 8.3, 8.4 8.4 Analysis of data ....................................................... 5.6.2, 7.4.1, 8.2.1, 8.2.2.3, 8.2.3, 8.2.4, 8.3, 8.4 8.5 Improvement ........................................................... 8.5 8.5.1 Continual improvement ............................... 5.3.1, 5.4, 5.6, 8.2.2.3, 8.4, 8.5.1, 8.5.2 8.5.2 Corrective action ......................................... 4.6, 7.6.4, 8.5 8.5.3 Preventive action ......................................... 4.6, 8.5
  • 44. DOCUMENT NUMBER: 99-9999 PAGE 44 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY 10 Appendices 10.3 <Business Unit> Quality Manual/Quality Management System Documentation Matrix The table below lists the sections by number and title of the <Business Unit> Quality Manual along with the applicable quality management system documentation associated with the quality manual (QM) sections. Sec. QM Section Title Quality Management System Documentation 1 Purpose 2 Scope 3 Applicable Documents 4 General 4.1 Definitions 99-9999 <Business Unit> Quality Manual 4.2 <Business Unit> Profile NA 4.3 Quality Management System Documentation 99-9999 <Business Unit> Quality Manual 99-9999 Departmental Document Control Policies and Procedures 4.4 Quality Manual 99-9999 <Business Unit> Quality Manual 99-9999 Distribution of Controlled Documents 99-9999 DMIS “<Company> Confidential” Requirements 4.5 Control of Documents 99-9999 Document Management Information Services Governing Spec for 99-XXXX SECC Documents 99-9999 Document Management Information Services Policies and Procedures for <Business Unit> Series Specifications 99-9999 Departmental Document Control Policies and Procedures 99-9999 Distribution of Controlled Documents 99-9999 DMIS “<Company> Confidential” Requirements 4.6 Control of Quality Records 99-9999 Virtual Factory Quality Records Retention Policies/Procedures 5 Management Responsibility 5.1 Management Commitment 99-9999 Departmental Document Control Policies and Procedures 5.2 Customer Focus 5.3 Quality Policy 99-9999 <Business Unit> Quality Manual 5.4 Planning
  • 45. DOCUMENT NUMBER: 99-9999 PAGE 45 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Sec. QM Section Title Quality Management System Documentation 5.5 Responsibility, Authority, and Communication 99-9999 <Business Unit> Quality Manual 5.6 Management Review 99-9999 <Business Unit> Management Review Policy and Procedure 6 Resource Management 6.1 Assignment of Personnel 6.2 Competence, Awareness, and Training 99-9999 Training Guidelines and Procedures for <Business Unit> New Hire Orientation Documentation 6.3 Infrastructure 6.4 Work Environment <Business Unit> Manufacturing Safety Handbook Office Safety Handbook 7 Product Realization 7.1 Planning of Product Realization 7.2 Customer-Related Processes 99-9999 Change Management Specification Plan It Manual 7.3 Design and Development 99-9999 Assembly/Test CCB Policies and Procedures 99-9999 Change Management Specification 99-9999 DPD Department Operations Process 99-9999 Software Development Process 99-9999 Product Design Integration Process 99-9999 Enabling Design Process 99-9999 Technology Design Integration Process 99-9999 Design Validation Process 99-9999 Product Package Design Requirements Document (PDRD) Process Applicable design rules Applicable library standards 7.4 Purchasing <Business Unit> Materials Desktop Procedures
  • 46. DOCUMENT NUMBER: 99-9999 PAGE 46 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Sec. QM Section Title Quality Management System Documentation 7.5 Production Provision 99-9999 Procurement specification for (Commodity) Materials 99-9999 <Business Unit> ESD Requirements 99-9999 Assembly/Test CCB Policies and Procedures 99-9999 Traceability and Bottomside Marking Requirements 99-9999 Standard Lot Numbering Specification 99-9999 Virtual Factory Quality Records Retention Policies/Procedures 99-9999 Chandler, AZ Site Environmental Controls Specification 99-9999 Unit Integrity/ Reject Management Specification 99-9999 C4/OLGA Traceability Requirements 99-9999 WorkStream Policies and Procedures for C4 OLGA and FC-PGA 99-9999 C4/FC-PGA Class 10,000 Cleanroom Protocol Guideline 99-9999 C4/FC-PGA Class 100,000 Cleanroom Protocol Guideline 99-9999 OLGA1, OLGA2, INT2, FC-PGA VF and MCM On- Hold/Off-Hold System Procedure 99-9999 Pack Procedure Applicable process operating and other specifications AzLO Desktop Operating Procedures Handling and storage procedures documented in individual specifications Online Summary of Electrical Test (OSET) Product build kits 7.6 Control of Monitoring and Measuring Devices 99-9999 Arizona Standards Lab Calibration Procedures 99-9999 Measuring Equipment and Calibration Policy 99-9999 Virtual Factory Assembly/Test Manufacturing Preventive Maintenance and Calibration Spec Individual manufacturing equipment specifications 8 Measurement, Analysis, and Improvement 8.1 Planning Monitoring, Measurement, and Improvement Activities
  • 47. DOCUMENT NUMBER: 99-9999 PAGE 47 OF 47 <COMPANY> CORPORATION, STREET ADDRESS, CHANDLER, ARIZONA ZIP IF PRINTED – REFERENCE COPY Sec. QM Section Title Quality Management System Documentation 8.2 Monitoring and Measurement 99-9999 Procurement specification for (Commodity) Materials 99-9999 ATMO Spec Template for 08 Series Specs 99-9999 A/T Internal Audit Policies & Procedures for Virtual Factories 99-9999 A/T Self Audit Policies & Procedures for Virtual Factories 99-9999 <Business Unit>/ATM Quality Audit Corrective Action Tracking Procedure using Speed 99-9999 FC-PGA/INT2 and OLGA VF Inspection Trouble Report (ITR) Procedures 99-9999 C4 & FC-PGA VF Material and Disposition Review Board Procedure 99-9999 Final Visual Inspection Procedure 99-9999 FC-PGA/INT2 and OLGA Virtual Factory Final QA Minimum Lot Acceptance Inspections Requirements and Procedure 99-9999 Quality System Auditing Policy 8.3 Control of Nonconforming Product 99-9999 Material and Disposition Review Board procedure 99-9999 Unit Integrity/Reject Management Specification 99-9999 OLGA1 and FC-PGA VF Process Trouble Report System 99-9999 Yield Issue Procedures and Guidelines 99-9999 OLGA1, OLGA2, INT2, FC-PGA VF and MCM On- Hold/Off-Hold System Procedure 99-9999 C4 & FCPGA VF Material and Disposition Review Board Procedure 8.4 Analysis of Data 8.5 Improvement 99-9999 Assembly/Test CCB Policies and Procedures 99-9999 A/T Internal Audit Policies & Procedures for Virtual Factories 99-9999 Excursion (DRB/MRB/ITR/PTR) Notification/Documentation in SPEED – Policies and Procedures 99-9999 C4 & FC-PGA VF Material and Disposition Review Board Procedure Departmentally controlled procedures for yield management Departmentally controlled procedures for FACRs