TQM1
TQM1
19 MAR 03 Rev P
EC 0990–1677–02
1. SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. APPLICABLE DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5. MANAGEMENT RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.1. Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.2. Customer Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.3. Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.4. Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.5. Responsibility, Authority and Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.6. Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6. RESOURCE MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.1. Provision of Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.2. Human Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.3. Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.4. Work Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7. PRODUCT REALIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.1. Planning of Product Realization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.2. Customer Related Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.3. Design and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
7.4. Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
7.5. Production and Service Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
7.6. Control of Inspection, Measuring and Testing Devices . . . . . . . . . . . . . . . . . . . . . . . . . 38
2 102–1, Rev P
TOTAL QUALITY MANAGEMENT PROCESS
1. SCOPE
For the purpose of this document, Tyco Electronics refers to the portion of the Tyco Electronics
Corporation that operates in North America (refer to Figure 1). Tyco Electronics Corporation is one
of the major operating units of Tyco International Ltd.
This Total Quality Management Process provides the basis for analyzing customer requirements,
defining the processes that contribute to the achievement of a product or service that is acceptable
to the customer, and provisions for keeping these processes in control. In recognition of the varying
organizational structures and needs of the Business Units, this quality manual may be
supplemented by additional detailed procedures. Such additional procedures may not be less
stringent than those provided herein unless specifically required in the customer contract; records
shall be kept of such contract exceptions.
102–1, Rev P 3
2. APPLICABLE DOCUMENTS
The following documents constitute a part of this specification to the extent specifically set forth
herein. Unless otherwise specified, the latest edition of the document applies.
4 102–1, Rev P
3. DEFINITIONS
Definitions contained in MIL–STD–790, ISO 9000, and Quality Specification 102–2 are
incorporated herein.
3.2. AMP
AMP is a product brand of the Tyco Electronics Corporation. Prior to Revision M of this document,
AMP was synonymous with the company.
3.4. Customer
The external recipient of a product or service.
3.5. Product
The output of a team or work unit, such as connectors, cables, relays, sensors, tools, molds, dies,
software, specifications, reports, or services.
102–1, Rev P 5
6
Tyco Electronics
Multi–Site
Quality Management System
102–1, Rev P 7
CUSTOMER MANAGEMENT
NEED RESPONSIBILITY
CONTRACT POLICY
ALIGNMENT
REVIEW
DESIGN RESOURCES
MATERIALS REVIEW
PURCHASING
RECEIVING
FEED–
BACK
8 102–1, Rev P
4.2. Documentation Requirements
4.2.1. Quality Policy and Quality Objectives
This quality manual contains the statement of the Quality Policy and Quality Objectives.
102–1, Rev P 9
Changes shall not be permitted in data records that verify product, process, or system acceptance
without adequate control and approval.
Corporate forms should be used where possible; equivalent forms may be generated
electronically as long as they contain the same information.
Customer supplied documents that can influence the design, verification, validation, inspection,
testing or servicing of the product shall be controlled in accordance with the established
procedures.
Documents shall be reviewed and changes implemented based on the customer required schedule. A record of
the date on which each change is implemented in production shall be maintained. (TS)
4.2.3.2. Changes
Subsequent changes to controlled documents shall be made in accordance documented
procedures and shall be reviewed and approved by the same functions that performed the original
review and approval unless specifically designated otherwise. The procedure shall require date of
approval and the effective date that product / document compliance to the change is required.
When changes are made to products or processes or when new processes are initiated that affect
the customer drawing or product specification, identified internal and external customers shall be
notified in accordance with documented procedures.
Product Part Approval Process (PPAP) documents shall be updated when affected by changes to controlled
documents. (QS)
All applicable Tyco Electronics Standards and Specifications – such as Design, Material, Mold,
Finish, Quality, and Packaging – shall be used. The applicable Engineering function shall be
responsible for the preparation, maintenance, standardization, and obsolescence of all standards
and specifications.
10 102–1, Rev P
4.2.4. Control of Quality Records
It is the responsibility of all Business Units to identify, collect, maintain, store, and dispose of quality
records to demonstrate conformance to established requirements and the effective operation of
the quality management system. Records shall remain legible, readily identifiable and retrievable.
Quality records include:
D Records of customer contracts that require less stringent quality systems procedures;
D Management quality system reviews;
D Employee qualifications and training records;
D Design, development, and testing activities;
D Customer contract and / or purchase order reviews;
D Design inputs;
D Design reviews and resulting actions;
D Results of verification and validation testing, including any necessary actions;
D Changes during the development process;
D Supplier records;
D Qualified processes, equipment, and personnel as appropriate;
D Unique identification of the individual product or lot – when traceability is a specified
requirement;
D Notification to the customer when customer property is lost, damaged, or is otherwise
unsuitable for use;
D Calibration records and test software verifications;
D Quality system audits;
D Inspection plans / control plans and results, including, as applicable, receiving, in–process,
and final;
D Records of nonconforming material transactions, including: inspection rejections, internal
rejections, deviations, customer complaints, and return material;
D Corrective and preventive actions;
D Other records as specified by the customer. (TS)
Safeguards shall be maintained for records on any media that protects against disaster, system
obsolescence, and loss.
102–1, Rev P 11
5. MANAGEMENT RESPONSIBILITY
Senior management shall monitor the product realization processes and the support processes to assure their
effectiveness and efficiency. (TS)
The various organizational structures and entities, such as teams, account management, industry
management and customer service are deployed by management to align our internal capabilities
with the needs of our customers.
5.4. Planning
5.4.1. Quality Objectives
The quality management system and sustaining processes must support the Quality Policy and
the company’s goal of achieving EBIT (Earnings Before Interest and Taxes) performance. An
effective quality management system will assist the company in meeting the needs of our
customers through the on time delivery of error free products and services. The quality
management system will provide for timely and effective corrective action and provide a factual
basis for continual improvement and defect prevention. Six Sigma Operational Excellence utilizes
12 102–1, Rev P
the DMAIC process to achieve breakthrough results. Performance against the targets that are
established for the applicable TL 9000 measurements will be monitored at the senior management
level:
102–1, Rev P 13
D Identification of customer special characteristics;
D Consideration and awareness of product safety issues relative to design and process control; (QS)
D Utilization of mistake proofing methodologies when planning processes, facilities, equipment and
tooling; (QS)
D Quality Planning, utilizing Automotive Industry Action Group (AIAG) QS–9000 Supplemental Manuals
(APQP and Control Plan, FMEA, SPC, MSA, and PPAP). (QS)
Senior management of the Business Unit shall define quality objectives that address customer expectations and
measurements that shall be included in the Business Plan and used to deploy the Quality Policy. (TS)
All levels of personnel have the authority to halt nonconforming processes and initiate,
recommend, or provide corrective / preventive solutions through designated channels.
D Ensuring adequate resources and trained personnel for management and support of work;
D Approving Six Sigma Operational Excellence projects, including the goals, objectives and
expected results;
14 102–1, Rev P
5.5.1.2. Quality Assurance Director or Manager Responsibilities:
The organizational Quality Assurance Directors and Managers shall have the authority and
responsibility for ensuring that the requirements of the Total Quality Management Process are
implemented and maintained.
D Regularly reporting to management the current performance of the Quality System and the
level of customer satisfaction as a mechanism for continual improvement;
D Ensuring that the Business Unit complies with the applicable requirements of ISO 9001,
TL 9000, and / or QS–9000 / TS 16949 standards;
D Providing liaison with external bodies on matters relating to the Quality System;
D Ensuring annually that the Business Unit has deployed the latest revision of ISO 9001,
TL 9000, and / or QS–9000 / TS 16949 that supports this Quality Manual;
D Notifying their certification body / registrar in writing within 5 working days when a customer places the
site in any of the following statuses: (QS)
D Chrysler “Needs Improvement” (QS)
D Ford Q–1 Revocation (QS)
D General Motors Level II Containment. (QS)
D Mentoring and supporting the Master Black Belts, Black Belts and Green Belts within the
Business or designated portion of the Business.
D Serving as the Six Sigma Operational Excellence Deployment Champion for Black Belt
projects within their facility or team;
D Participating in the periodic review of the Total Quality Management Process and the
implementation of any identified required improvements;
D Ensuring that adequate resources are assigned and made available for the completion of
the appropriate quality activities within their assigned scope of responsibility;
D Determining the sequence and interaction of the processes needed to maintain the quality
management system;
102–1, Rev P 15
D Ensuring the availability of information necessary to support the operation and monitoring
of these processes;
D Ensuring compliance with applicable safety and regulatory requirements.
16 102–1, Rev P
D Coaches and assists the Black Belts and Green Belts with the technical aspects of the
DMAIC process.
102–1, Rev P 17
5.5.2.1. Total Quality Management Committee
This is an ad hoc committee composed of the Quality Management, which has the following
responsibilities:
D Assisting senior management with the deployment of the Total Quality Management
Process;
D Providing input to training programs with regard to policies and procedures relating to
customer quality and reliability activities.
The management team of a Business Unit is responsible for local deployment of the Total Quality
Management Process and for reviewing the quality management system. The purpose of the
review is to assess the adequacy of resources, effectiveness and continuing suitability of the
quality system. This review shall include all elements of the entire quality system and must be
conducted at least annually.
18 102–1, Rev P
Management review shall include all elements of the quality management system, performance trends,
monitoring the quality objectives and reporting and evaluation of the cost of poor quality. Results of the review
shall address achievement of the objectives specified in the Quality Policy and Business Plan and customer
satisfaction. (TS)
D Audit results;
D Feedback from customers;
D Process performance and product conformity;
D Status of preventive and corrective actions;
D Follow up actions from previous management reviews;
D Changes that could affect the quality management system;
D Improvement recommendations;
D Analysis of actual and potential field failures and their impact on quality, safety or the environment; (TS)
D Design and development project summary measurements. (TS)
D Improvement of the effectiveness of the quality management system and it’s supporting
processes;
102–1, Rev P 19
6. RESOURCE MANAGEMENT
20 102–1, Rev P
6.2.2.3. Quality Training
To ensure that there is an awareness of the importance of quality, employees who have a direct
impact on the quality of the products, including the senior management, shall be trained in the
fundamental concepts of quality improvement, problem solving and customer satisfaction.
Personnel whose work can affect quality shall be informed about the consequences to the customer when there
is a nonconformance to specified quality requirements. (TS)
A documented procedure shall be established and maintained for identification of training needs and
achievement of competency of all personnel performing activities affecting product quality. Attention shall be
given to satisfy any customer specific requirements. (TS)
The Business Unit shall have a process to measure the extent to which employees are aware of the relevance and
importance of their activities and how they contribute to the achievement of the quality objectives. (TS)
6.3. Infrastructure
Business Unit management shall define, provide and maintain the infrastructure necessary to
ensure that product conforms to established requirements.
102–1, Rev P 21
6.4. Work Environment
Facilities, including workstations and associated equipment, shall be maintained in a state of
order, cleanliness, and repair appropriate to the product(s) manufactured or to the service being
provided. All work areas must comply with established safety, regulatory and environmental
standards and codes.
The established requirements, as described in the Quality Policy, include addressing of product safety and
means to minimize potential risks to employees. These requirements shall especially be addressed in design,
development, and manufacturing process activities. (TS)
22 102–1, Rev P
7. PRODUCT REALIZATION
102–1, Rev P 23
D Accurately defining the market demand and sector, since doing so is important in
determining the grade, quantity, price, and timing estimates for the product or service;
In those cases where there is an established cross–reference between the customer part number
and a Tyco Electronics part number, the Sales Correspondent shall review the order to confirm the
pricing and delivery requirements. If any discrepancies are observed, the order is reconciled within
the Business Unit and transmitted to the Sales Correspondent. Booking the order is confirmation
that there are no known discrepancies between the customer request and the ability to meet the
request.
24 102–1, Rev P
D The Development / Product Engineering function shall be responsible for determining
product compliance with the customer’s requirements and the initiation of the
cross–reference process;
D The Quality function shall be responsible for determining compliance to those quality
requirements that include measurement data, performance criteria, verification
requirements, customer special requirements, audit parameters and processing customer
complaints;
D The Materials function shall be responsible for determining compliance to the delivery
requirements;
D The Contracts Administration function in conjunction with the Legal Department, shall be
responsible for review of any contract documents containing other than Tyco Electronics
standard terms and conditions;
D The Manufacturing Engineering function shall investigate, confirm and document the manufacturing
feasibility of the proposed products, including risk analysis. (TS)
The Sales and Marketing organization is the primary interface for ensuring that all customer
requests for information are satisfied. In addition, there are multiple electronic systems to assist
customers in obtaining product information.
Customer Service is the primary function for providing responses to customer inquiries about
purchase orders and delivery dates.
Quality Assurance is the primary function for establishing the process for resolving customer
complaints, including problem escalation, customer feedback and product recall. Quality
Assurance, in conjunction with Field Sales, is also responsible for communicating with customers
during the resolution of complaints or product nonconformity issues.
Customer communications shall include the ability to exchange information and data in a customer–specified
language and format. (TS)
The design of a product must be the result of thorough and careful consideration of the customer’s
requirements, the potential use of the product, the potential product life cycle and the
manufacturability of the product. The following activities shall be the responsibility of Business Unit
Engineering and Quality functions. Records shall be kept of design, development, and testing
activities.
102–1, Rev P 25
7.3.1.1. Project Planning
Timely project plans shall be prepared by engineering management that identify the responsibility,
budgets, staffing and schedules for each design and development activity. The plans shall be
updated and communicated to the appropriate individuals as each design evolves. The plans,
based on the life cycle model, shall describe or reference the following activities, as applicable:
D Organizational and technical interfaces between different groups (internal and external)
shall be identified and the necessary information documented, transmitted, and reviewed;
A preliminary document clearly marked “Design Objectives” shall be prepared for use during
engineering development and related testing activity by the Development / Product Engineering
function, with the assistance of the Quality and/or Reliability Engineering functions. This
specification shall define the intended performance characteristics.
26 102–1, Rev P
D Performance characteristics such as environmental and usage conditions, including any
reliability requirements;
D Manufacturability of design, including any design constraints, nominal values and tolerances; (QS)
D Appropriate resources and facilities to utilize computer–aided product design, engineering and
analysis and technical leadership for these functions if subcontracted; (QS)
D CAD / CAE systems two way interface with customer systems; (QS)
D Establishment of targets for product quality, life, reliability, durability, maintainability, timing and
cost. (TS)
102–1, Rev P 27
7.3.2.2. Manufacturing Process Design (TS)
The manufacturing process design shall be identified, documented and reviewed. Design inputs shall
include: (TS)
D Result from a process that makes appropriate use of the Basic and Advanced Quality
Tools, such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA);
Statistical Tolerance Analysis, etc.;
28 102–1, Rev P
D Data for quality, reliability, maintainability and measurability; (TS)
D Results of error–proofing activities as appropriate; (TS)
D Identification of methods for rapid detection and feedback of product and process
nonconformances. (TS)
The design review activities shall include verification that the design output meets the design input
requirements as identified by the customer or Marketing, the identification of any problems and
their proposed resolution. Design verification shall include, as appropriate, alternative
calculations, comparison to a comparable proven design, and / or testing.
7.3.4.1. Confidentiality
Confidentiality of customer–contracted products under development and related product
information shall be ensured.
D Investigate potential failure modes and verify their effects on both the design and the
manufacturing processes;
D Demonstrate the product design capability for each performance characteristic specified in
the design objectives. The design of these tests should consider mechanical and
environmental stresses at least as severe as the design objectives, the necessity to
generate data for statistical analysis, and, when required, the establishment of a reliability
statement.
Records of the results of verification testing and any necessary actions shall be maintained.
102–1, Rev P 29
7.3.6. Design and Development Validation
Following successful completion of design verification, product for sale shall be validated to ensure
compliance with the product specification. All requests for qualification / requalification shall be
submitted to a Tyco Electronics test laboratory. When necessary, actual testing may be performed
at other qualified test facilities, but shall be under the coordination and approval of the Tyco
Electronics test laboratory receiving the initial test request.
A report of the results shall be prepared, and any differences between specification requirements
and test data must be reconciled and documented, to permit product qualification. Successful
qualification shall permit removal of the “Design Objectives” qualifier from the product
specification.
Records of the results of validation testing and any necessary actions shall be maintained.
For proprietary designs, impact on form, fit, function, performance and reliability shall be reviewed with the
customer. (TS)
30 102–1, Rev P
7.4. Purchasing
7.4.1. Purchasing Process
Purchasing, in consultation with the Business Unit, Advanced Materials Technology, Product
Engineering, Manufacturing, Supplier Quality Assurance and Legal, is responsible for supplier
selection. Purchasing is also responsible for on–going support, risk analysis, supply base
management, technical leadership, contract definition and ensuring that proprietary, usage and
licensing agreements are completed. Order releases may be done by the Purchasing function, the
Materials organization, or Contract Administration. To ensure that the supplier has the necessary
documentation to provide what is requested, Purchasing is responsible for coordinating with the
appropriate function such items as drawings, referenced specifications, packaging and labeling
requirements, and quality assurance requirements for all initial purchase orders. This
documentation shall be updated by the appropriate function to include any changes on an
as–needed basis and shall be transmitted to the supplier by Purchasing. Records of acceptable
suppliers shall be maintained. Purchased product shall comply with all governmental, safety, and
environmental requirements for the country of manufacture and sale.
In the event an external customer has an approved subcontractor list, the responsible Business
Unit must coordinate with Purchasing to make sure that those suppliers are included in the Tyco
Electronics supply base. Tyco Electronics is responsible for products and services purchased from
customer designated suppliers. Optionally, the Business Unit may work with the customer to have
the Tyco Electronics supplier added to their list of approved suppliers.
The supplier shall comply with the applicable legal and environmental requirements.
The supplier’s quality system shall be subject to development by Tyco Electronics as required.
Options for development may include training, supplier days, and one–on–one sessions with
suppliers for corrective action review.
102–1, Rev P 31
Suppliers shall be third party registered to ISO 9001:2000 with the goal of compliance to TS 16949. (TS)
Additional development activity can be identified utilizing the monthly supplier reports that are sent
to the supply base. Purchasing / Supplier Quality Assurance, in response to poor performance as
identified by the reports and based on status and importance, will solicit corrective actions to
eliminate this poor performance. Additional assistance may be offered to the supplier if the development
activity or corrective action is determined by the Business Unit to be significant. (QS)
Business Units shall utilize the Logistics reporting for the tracking of premium freight charges. Tracking shall
facilitate whether the premium freight was for inbound or outbound freight. (QS)
32 102–1, Rev P
D Skip lot inspection – lots of received material are inspected as defined by a skip lot plan.
D Product is evaluated and reported as acceptable by an accredited supplier or test
laboratory.
In the event that materials are needed for manufacturing commitments before receiving inspection
is complete, a plan shall be developed to provide for positive identification and control of the
product produced until the material is deemed to be acceptable.
Unless the manufacturing site or the Business Unit implements specific directives, material
received from other locations or subsidiaries of Tyco Electronics shall be processed directly into
stock without receiving inspection of product characteristics. Product acceptance shall be
completed as defined in documented procedures. In all cases it is the responsibility of the
supplying operation to ensure the product meets established requirements.
Tyco Electronics shall comply with reference standards and codes, engineering / production
drawings and specifications, quality plans and other documented procedures to monitor and
control suitable process parameters and product characteristics. These product characteristics
include special characteristics, which need specific attention because excessive variation might
affect a product’s safety, compliance with customer specified characteristics, government
regulations, fit, function, appearance or the quality of subsequent manufacturing operations.
Qualified operators shall carry out the processes.
Tyco Electronics shall identify key process equipment, monitoring / measuring devices and provide
appropriate resources for machine / equipment maintenance and develop an effective, planned
total preventive maintenance system. Maintenance activities are deployed to sustain process
capability requirements and product quality requirements. As a minimum, the preventive maintenance
system shall include planned maintenance activities, packaging and preservation of equipment, tooling and
gauging, availability of replacement parts for key manufacturing equipment and documenting, evaluating and
improving maintenance activities. (TS)
Records shall be maintained for qualified processes, equipment and personnel, as appropriate.
Predictive maintenance methods shall be used to continually improve the effectiveness and efficiency of
production equipment. (TS)
102–1, Rev P 33
7.5.1.1. Control Plans (TS)
Control plans shall be developed and maintained for pre–launch and production operations for raw materials,
components and finished product. Control plans shall consider the output from the design and process FMEA’s.
Control plans shall include: (TS)
The Business Unit is responsible for monitoring these activities when any of this work is completed by external
suppliers. (TS)
7.5.1.3. Delivery
Tyco Electronics shall arrange for storage that will protect the quality of product after final
inspection and test. Product shall be shipped to customers in accordance with the requirements
recorded on the distribution shipping papers.
34 102–1, Rev P
7.5.1.3.3. Delivery Performance Monitoring
Tyco Electronics shall have a systematic approach to develop, evaluate and monitor adherence to
established lead–time requirements. A system shall be implemented to monitor performance to
customer delivery requirements where corrective actions shall be taken as appropriate.
7.5.1.4. Servicing
When applicable, procedures shall be established and maintained to ensure that contractual
service agreements and product warranties are fulfilled. The procedures shall address verification
that service meets customer requirements and / or expectations and that appropriate
manufacturing, engineering, and design activities are aware of service concerns. When these
procedures exist, problem severity, classification, resolution, training of servicing personnel (TS) and
emergency service processes shall be addressed.
Process studies shall be completed on all new manufacturing processes to verify process capability and provide
input for control of the process. Manufacturing process documentation shall include operating procedures,
measurement, test and maintenance procedures. Objectives for manufacturing process capability, reliability,
maintainability, capacity and acceptance criteria shall be documented. (TS)
Process capability or performance shall be maintained as specified by the requirements of the customer part
approval process. And shall ensure implementation of the control plan and process flow diagram, including
adherence to the specified measurements techniques, sampling plans, acceptance criteria and reaction
plans. (TS)
102–1, Rev P 35
Reaction plans for either unstable or non–capable processes should include containment of process output and
100% inspection. A corrective action plan shall then be completed indicating specific timing and assigned
responsibilities to assure that the process becomes stable and capable. The plans are to be reviewed with and
approved by the customer when so required. (QS)
36 102–1, Rev P
7.5.3.1. Inspection and Test Status
All production materials in–process or in inventory shall be identifiable as acceptable for further
processing or shipment. This marking shall appear on each unit container used for handling and
storage. This marking may be on cartons, reel tags, routing cards, product travelers, or any other
suitable location, provided there is a clear indication that prior verification operations have been
performed. The verification status indication shall permit identification of the operator(s) /
inspector(s) who performed the prior inspection(s) or review. Records shall be maintained of
authorized identifiers.
When required by the customer, additional verification / identification requirements shall be met. (TS)
When the status is identifiable through machine–readable code, there shall be sufficient
information provided to identify verification status when the reader is not available.
It shall be the responsibility of the supervisor of any stores area to receive into stock only items that
are clearly identified as acceptable.
For the service and support areas of the company, an appropriate indication of approval shall be
used; when verification is electronic, this identifier shall take into account computer security
measures.
Designated distribution warehouse storage areas, general warehouse storage areas or stock
rooms are utilized to prevent damage or deterioration of product, pending use or delivery.
Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated.
Each stocking location shall apply appropriate methods for preservation and segregation of
102–1, Rev P 37
product to ensure that material or product will remain undamaged pending use or delivery. In order
to detect deterioration, each stocking area shall, at appropriate intervals, assess the condition of
the product.
Inventory systems to optimize inventory turns over time, assure stock rotation, and minimize
inventory levels shall be utilized.
Packaging and labeling / marking processes shall be controlled to the extent necessary to ensure
conformance to established requirements. This shall include systems to conform to specific
customer packaging and labeling requirements.
7.5.5.3. Shelf–Life
Materials that have a shelf life shall be clearly marked with an expiration date, or a date of
manufacture that can be used to calculate an expiration date. Materials shall not be used past the
expiration date.
38 102–1, Rev P
D All inspection, measuring and test equipment that does not require calibration shall be
appropriately identified.
D A process shall be established that assesses the validity of previous inspection and test
results when measuring devices are found to be out of calibration. Records of this
assessment shall be maintained.
D Conditions shall be established that provide a suitable environment for calibration and use
of measuring devices and that these devices are stored and handled in a way that
maintains accuracy and fitness for use.
D Methods shall be developed to safeguard measuring devices, including test hardware and
software, from adjustments which would invalidate the calibration settings.
D Appropriate statistical studies of the variation present in measurement and test systems
shall be completed as part of process capability analysis and as specified in customer
approved control plans. Such studies shall conform to generally recognized measurement
system analysis methodologies.
D All product produced with suspect measuring equipment shall be segregated and audited.
Customer notification / product recall shall be considered if suspect product was shipped.
D Non–standard measuring equipment, such as pin detectors, vision systems, etc., shall be
verified by the local manufacturing location by using product having known defects or other
suitable means. This internal verification schedule shall be established by the Product /
Manufacturing Team. The verification results shall be recorded.
D Devices that are either inactive or unsuitable for use shall be visibly identified and shall not
be used.
The variation of measuring and test equipment referenced in the control plan must be analyzed through the
completion of appropriate statistical studies. (TS)
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8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
The appropriate personnel should understand basic statistical concepts such as variation, control
(stability), process capability and over–adjustment. Understanding and deployment of statistical
concepts shall be accomplished through training and documented procedures; refer to Manual
402–105 (Quality tools and Statistics Reference Guide).
Appropriate statistical tools for each process shall be determined during the advanced quality planning process
and included in the control plan. Basic statistical concepts shall be understood and utilized throughout the
organization. (TS)
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D Meetings with customers;
D Ship to customer request performance.
Customer satisfaction / dissatisfaction will be included as a topic within the senior level
management review. If applicable, actions taken will be monitored within the management review
process.
Customer recognition and awards are posted on the Tyco Electronics Intracomm and the Quality
Systems and Engineering Assurance websites. In addition, numerous other reporting methods
exist, including Global Delivery Scorecard, backlog status, Customer Service metrics and local
QOS reviews.
Performance indicators for customer satisfaction shall be based on objective data and include, but not be limited
to: (TS)
Each organization shall conduct audits of the quality system in accordance with established
specifications at regular intervals based on status and importance of the activity. Audits of the
quality system shall be carried out by qualified personnel independent of those having direct
responsibility for the area being audited and should cover all shifts. Follow–up audit activities shall
verify and record the implementation and effectiveness of the corrective action taken.
Internal audits shall cover all the quality system, activities and shifts and shall be completed in accordance with
an annual plan. When nonconformities (internal and external) or customer complaints occur, the audit
frequency shall be appropriately increased. (TS)
The effectiveness of each manufacturing process shall be evaluated through audits that are completed at
defined intervals. Product audits shall be completed at appropriate stages of the production process. (TS)
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8.2.2.1. Customer Surveys and Inspection of Facilities
Tyco Electronics recognizes that it will be necessary for some customers to perform supplier
audits. During such customer surveys, source inspections, or quality audits, employees shall
neither demonstrate nor discuss manufacturing equipment, processes, methods, etc. which are
considered to be proprietary. In those circumstances where the customer may require additional
information about aspects of manufacturing considered proprietary, additional consideration may
be possible through the use of confidential disclosure agreements.
D Development and deployment of training to bring actual practice into alignment with
documented requirements;
D Change the documented requirements to ensure alignment with current business needs
and practices;
Where applicable, inspection plans shall classify characteristics for impact on the customer. This
impact shall be guided by the following:
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D Major characteristic – a characteristic other than critical, where nonconformance renders
the product incapable of performing its intended function or materially reduces the usability
of the product or service;
Where operator inspection or automatic inspection devices are utilized to determine product
acceptance, appropriate product auditing shall be maintained to insure the integrity of the Quality
System.
Where in–process inspection, test, or review operations are performed by other than the Quality
function (such as an engineer, technician, operator, setup person, or team member), records of
verification performed and results of that verification must still be provided and retained.
One of the goals of the quality system is to direct process activities toward defect prevention methods rather
than defect detection. (QS)
All finished goods shall have visible indication of acceptability. This acceptability indication
normally shall be applied during or following the final manufacturing inspection operation.
However, if the Quality function has identified the need for a final inspection or audit operation, the
evidence of acceptability will be applied after product compliance is verified.
Quality Assurance shall coordinate the activity of layout inspection and functional verification at a
frequency as negotiated with the customer.
Final package material audits (e.g. product integrity, packaging, labeling, documentation, quantity,
marking) should be scheduled at appropriate intervals.
Attribute sampling:
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D Major and minor characteristics shall be subjected to zero–acceptance–number sampling
plans.
Variables sampling plan shall be in accordance with the quality inspection plan or control plan as
applicable.
8.2.4.4. Re–Testing
If design changes or changes to the manufacturing process that have the potential of affecting the
form, fit, or function of the product are specified by customer requirements, agency requirements
or when determined by a requirement established within the design review process, the Quality
function shall coordinate requalification testing. Product / Development Engineering, in concert
with the test laboratory, will define the content of the re–testing. Requalification tests may be
limited to those tests that are affected by the design or manufacturing process change. Quality
Assurance may also request requalification testing in response to analysis of field failure data,
product extensions, manufacturing process location changes or material changes. The utilization
and frequency of requalification testing shall be in accordance with the customer contracts or as
established by the Business Unit Quality and Engineering functions to periodically reassess the
ability of the product to continue to meet the requirements of the product specification.
D Controlling further movement of the material to prevent material from unintended use or
delivery;
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Nonconforming product may be released for use when a deviation has been processed and
approved. All deviations shall clearly specify the temporary limits of acceptability, state the
definitive corrective action and be approved by the appropriate engineering functions. If the
affected dimension, feature, or characteristic is a specified customer requirement, no deviation
shall be issued unless the customer has granted documented concession. This applies equally to
product or services purchased from suppliers. The Business Unit shall concur with any requests by
a supplier before submission to the customer. The Business Unit shall maintain records of the
expiration date or quantity authorized. The Business Unit shall also ensure compliance with the
original or superseding specification and requirements when the deviation expires. Internally,
components shipped under deviation shall reference the deviation number on each unit container.
Material shipped with authorization for concession shall be identified on each shipping container
as required by the customer.
If the nonconforming material is accepted for rework / repair, rework instructions shall be provided
and the material shall be reinspected to an approved quality plan before it returns to the process.
Authority to dispose of defective material shall be defined by the manufacturing organization.
Records of nonconforming material transactions, including deviations, shall be maintained.
8.5. Improvement
One of the major objectives of the Tyco Electronics Total Quality Management Process and the Six
Sigma Operational Excellence initiative is to foster improvement in all aspects of our business. The
company strives to improve the satisfaction of our customers with our products and services. This
can be best accomplished by the on–going initiatives to improve the quality and reliability of our
products and to improve the operating effectiveness of the manufacturing equipment and
processes. Employees are encouraged to review the information posted on the Tyco Electronics
Intracomm website to learn more about the various improvement tools and for feedback on
customer satisfaction.
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8.5.1. Continual Improvement
The Business Units shall promote and manage continual improvement in quality, productivity,
service, and value. Improvement projects shall include as appropriate: external customer,
corporate, supplier, safety and regulatory requirements. Continual improvement shall be
measured against goals and objectives. One or more of the following techniques may assist with
achieving the goals and objectives:
D LEAN:
A series of tools and techniques that focus on process optimization through cycle time
reduction and the elimination of waste.
D Management Methods:
Self Assessment and Gap Analysis (SAGA), ISO 9001 / AS 9100 / ISO 9004 / TL 9000 /
QS–9000 / TS 16949 assessments, benchmarking, suggestion systems, taskforce teams,
cross functional teams, Performance for Business Results, performance reviews, training,
apprentice programs, bonus programs and business planning.
Continual improvement shall focus upon control and reduction of variation in product characteristics and
manufacturing process parameters. (TS)
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8.5.1.1. Quality Improvement Program
The spirit of our quality improvement program is to cost effectively achieve the basic tenets of the
Tyco Electronics Quality Policy: delivery of error free products and services, on time. Improvement
initiatives should be directed at reaching this state of “zero defects”. This quality improvement
program consists of many activities including:
D The on–going review of this Quality Manual and the supporting documents;
D Actions resulting from audits, management review, corrective action, preventive action and
the Quality Operating System (QOS) process;
As stated in the Quality Policy, continual improvement is the personal responsibility of each
employee. Formal methods for encouraging employee involvement may include: employee
recognition systems, employee suggestion systems, department / shift / team meetings, bonus
programs, and participation on problem solving or improvement teams.
A system shall be implemented and maintained to transfer any customer complaints to the owning
Business Unit such that the issues may be resolved in a timely fashion as defined by the customer.
Where a nonconformance is identified, the responsible Business Unit shall implement corrective
action according to documented procedures. Unless there is a specific format required by the
customer, the Eight Discipline (8–D) process for problem solving and corrective action shall be
utilized for all complaints received from external customers. Consideration should be given to
utilizing the Eight Discipline process when responding to internal failures. Corrective action shall
be to the degree appropriate to the magnitude of the problem and commensurate to the risks
encountered. Understanding the benefits, risks, and costs are crucial in maintaining a balance in
implementing the Total Quality Management Process. The corrective action process shall include
but not be limited to:
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D The effective and timely handling of customer complaints, return of defective material,
reports of product nonconformance (from internal operations and external suppliers), and
internal and external audit corrective action requests;
D Determining the corrective action needed and applying controls to ensure corrective action
is taken and root cause has been addressed;
Records of the results of action taken shall be maintained and shall be included as an input for
management review.
D Design FMEA’s;
D Process FMEA’s;
D Quality Function Deployment;
D Similar product / process baselining / benchmarking;
D Design of Experiments.
The second form of preventive action is the elimination of potential failure modes when information
from processes, systems, work operations, process capability studies, yield analyses, deviations,
concessions, quality records, audit reports, service reports, or customer complaints suggests a
nonconformance may occur. Steps shall be taken according to documented procedures to
eliminate potential nonconformances. The minimum, preventive action process should include,
but not be limited to:
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D Reviewing preventive action activities by management for trends and impact on
procedures, products, processes, and systems.
D The responsible function shall change the requirements for the item in question so that the
nonconforming condition is acceptable by specification or drawing; or
Define:
D Identify the gap in meeting the business strategy or objective
D Establish the scope and boundary for the project
D Identify the Black Belt and the project team
D Establish the project goals and savings
D Obtain the endorsement of the Business Executive
Measure:
D Understand the current process
D Characterize the baseline performance
D Determine measurement capability
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Analyze:
D Understand the key product performance characteristics and how they are impacted by the
process variables
D Understanding of the relationship between the input and output variables
Improve:
D Identification of the root cause of the variation
D Identification of what needs to be done to close the performance gap
D Deploy appropriate tools
Control:
D Document revised process parameters to maintain the gains
D Return the process to the process owner and sustaining operations
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