Professional Documents
Culture Documents
Wes Westberg
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CONTENTS
Quality/Environmental Manual.............................................5
SOP 4.2.2..............................................................................5
Scope.................................................................................5
Procedures..............................................................................78
Documentation Requirements................................................79
SOP 4.2...............................................................................79
Control of Documents............................................................82
SOP 4.2.3............................................................................82
Control of Records.................................................................85
SOP 4.2.4............................................................................85
Management Review.............................................................88
SOP 5.6...............................................................................88
Competence Awareness & Training......................................94
SOP 6.2.2............................................................................94
Control of Nonconforming Product.......................................98
SOP 8.3...............................................................................98
Corrective and Preventive Action........................................101
SOP 8.5.2/8.5.3.................................................................101
Work Instructions................................................................105
WI-SB-5.2.2.....................................................................105
Work Instructions................................................................107
WI-DL-6.2.2.....................................................................107
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Management Review FC-MR-5.6........................................110
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QUALITY /ENVIRONMENTAL
MANUAL
SOP 4.2.2
SCOPE
GENERAL
Page: 5
ISO/TS 16949 Automotive Certification Scheme-Rules
for Achieving IATF Recognition and all related
documents
Company Background
XXXX,
XXXX
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APPLICATION
Our Quality/Environmental Systems comply with all
applicable requirements contained in ISO/TS 16949:2002,
covers the design and provision of all company products, and
encompasses all operations at both of our facilities. The
following table identifies the requirements not applicable to
our organization and provides a brief narrative justifying their
exclusion from the scope of our Quality/Environmental
Systems:
1. Reference Documents
The following external documents contain provisions, which,
through reference in this manual, constitute provisions of our
Quality/Environmental Systems:
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CSR-DC, DaimlerChrysler (Chrysler Group)
Customer-Specific Requirements for Use with
ISO/TS 16949:2002
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3. Quality Management System
GENERAL REQUIREMENTS
The responsibility belongs to Top Management for
defining the organization’s quality and environmental
policy and to ensure the documented, communicated, and
understood throughout the organization.
Management review meetings, include the Quality and
Environmental policies and objectives for continuing
suitability.
Our Quality/Environmental Systems is part of our overall
management system, which establishes documents and
implements our quality policy, and related processes for
providing products and services, which meet or exceed
customer requirements, and satisfies Quality/
Environmental Systems requirements of ISO900/14001.
We have adopted the process approach advocated by ISO
9000, by defining and managing:
Process inputs, controls, and outputs to ensure desired
results are achieved, and
Interfaces between interrelated processes to ensure
system effectiveness.
Specific responsibilities for and the sequence and
interaction of our key Quality/Environmental Systems
processes are detailed in the Standard Operating
Procedures (SOPs), many of which contain or reference
deployment flow charts depicting the process or procedure
described in the narrative SOP. Appendix A contains a
List of Key Quality/ Environmental Systems Documents,
including all SOPs and other key Quality/Environmental
Systems documents.
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GENERAL REQUIREMENTS – SUPPLEMENTAL
We also recognize the significant role that subcontractors
play in achieving desired results and recognize that we
must ensure proper control over outsourced Quality/
Environmental Systems processes (Section 7). Our
flowcharts depict outsourced processes and procedures
describe the governing of their management in documents
referenced in applicable SOPs.
DOCUMENTATION REQUIREMENTS
GENERAL
The Management, through the Management Team, is
responsible to implement and maintain a quality and
environmental management system, and continually
improve its effectiveness.
Quality/Environmental Management System processes,
including their sequence and interaction with other
processes, we identify and document in this Quality/
Environmental Manual, and managed in accordance with
ISO and customer requirements. Management reviews the
identified and documented indicators for measurement
and analysis to assure effectiveness and efficiency.
The Management ensures that adequate resources and
information necessary to support the operation,
monitoring, measuring, and analysis of these processes is
made available and actions necessary to achieve planned
results and support continuous improvement.
Each Department Manager is responsible for evaluating
and adjusting resource requirements to efficiently execute
assignments and accomplish goals defined in the business
plan, including the implementation and control of the
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Environmental Management System. Management gives
individuals total support and the necessary authority to
perform the assigned tasks.
The Company recognizes that control of any outsourced
processes is necessary in order to ensure the product
conforms to customer requirements.
Quality/Environmental Systems documents and data may
be in hard copy or electronic media. This quality manual,
SOPs, and other internal and external documents and data
needed to manage, perform, or verify work affecting
product quality. We use SOPs and flow charts to
document and define the key Quality/Environmental
Systems processes. We also issue and control work
instructions, job descriptions, and other internal and
external documents and data as appropriate and needed to
manage our systems (Section 4).
QUALITY MANUAL
This manual is that part of our Quality/Environmental
Systems defines the scope of our Quality/Environmental
Systems and documents the policy, procedures, and
processes needed to implement our quality policy and
achieve our quality objectives. This manual also shows
our justification for any exclusion from ISO/TS
16949:2002 requirements (Section 1) and defines the
overall sequence of between our key
Quality/Environmental Systems processes.
CONTROL OF DOCUMENTS
Quality/Environmental records represent information that
demonstrates conformity to Quality/Environmental
Systems requirements and effective operation of The
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Company’s’ Quality and Environmental system. Pertinent
records from our subcontractors are an element of this.
Each Process Owner is responsible for identifying which
records they consider quality and environmental records
and for collection, storage, protection, retrieval, and the
retention and disposition of these records
Quality and Environmental records are legible, readily
available and retained for a specified period in Quality
Record Matrix. Record retention must satisfy both
regulatory and customer requirements, as well as ISO or
TS requirements. When we reach retention time, records
should be disposed of accordingly.
The information Quality Manager has overall
responsibility for ensuring that all Quality/Environmental
Systems documents, below includes forms used to create
controlled quality records as detailed in procedure SOP
4.2.3:
a) Approve documents for adequacy prior to issue.
b) Review, update as necessary, and re-approve
documents.
c) Identify the current revision status of documents.
d) Ensure that relevant versions of applicable
documents are available at points of use.
e) Ensure that documents remain legible, readily
identifiable, and retrievable
f) Ensure that identified external documents (including
customer-engineering standards/specifications) have
controlled distribution
g) Prevent the unintended the use of obsolete
documents, and to apply suitable identification to
them if they are retained for any purpose.
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ENGINEERING SPECIFICATIONS
The Program Manager oversees our process for assuring
the timely review, distribution, and implementation of all
customer-engineering standards/ specifications and
changes based on customer-required schedule; The
Company uses a Product Data Management system to
manage and control engineering records and data (see
SOP 4.2.3).
The Company considers reviews timely if performed
within two working weeks of receipt. When a change
involves standards or specs that are reference on design
records, or they affect PPAP documents, we submit an
updated PPAP.
(Section 7)
MASTER LISTS
We define requirements for the establishment and
maintenance of Master Lists of internal and external
Quality and Environmental Systems documents in SOP
4.2.3.
CONTROL OF RECORDS
Quality/Environmental records represent information that
demonstrates conformity to Quality/Environmental
Systems requirements and effective operation of The
Company’s’ Quality and Environmental system. Pertinent
Records from our sub-contractors are an element of this.
Records may be in the form of hard copy or electronic
media. SOP 4.2.4 details procedures necessary to control
Quality/Environmental Systems records that, as a
minimum, are prepared to document:
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a) Results of processes performed, including
identification of the individual performing the activity.
b) Product/process evaluation/acceptance criteria
c) Procedures, drawings, or instructions used to perform
an activity, including revision or date of document.
d) Identification of material, parts, or equipment used in
the making of the product
e) Personnel, material or equipment qualifications
f) Pertinent technical records from sub-contractors
RECORDS RETENTION
SOP 4.2.4 contains related procedures and responsibilities to
ensure:
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legal requirements) through continual improvement of our
processes, products, and services.
PROCESS EFFICIENCY
Top management reviews product realization and support
processes to assure both effectiveness and efficiency during
management reviews (Section 5).
CUSTOMER FOCUS
Customer requirements are determined during Quoting and
Contract review processes. Top Management ensures that we
meet these requirements with the aim of enhancing Customer
Satisfaction, through Customer feedback and the following
activities:
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The Company continually monitors and measures
customer complaints and other customer input/ feedback
to identify opportunities for improvement (Section 8).
These customer focused communications and
interactions ultimately yield clear, explicit customer
requirements and expectations in the form of a
contractual agreement or customer order; the Managing
Director has overall responsibility for ensuring that
specified and unspecified requirements are determined,
understood, and converted into requirements (Section
7).
Our quality policy statement indicates our commitment
and focuses on what is important to us as an
organization: achieving customer satisfaction; and it
prescribes the method by which we accomplish this: by
continually improving processes, products, and services
to ensure they consistently meet or exceed requirements.
Moreover, our quality policy statement acts as a
compass in providing the direction and a framework for
establishing key corporate level performance measures
and related improvement objectives. (Section 5)
We ensure that our quality policy is communicated and
understood at all levels of the organization through
documented training, regular communication, and
reinforcement during annual employee performance
reviews (Section 6).
We control our quality policy statement by including it
in this manual, and along with all policies contained in
this manual, is reviewed for continuing suitability
during management review meetings (Section 5).
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QUALITY/ENVIRONMENTAL POLICY
Management review meetings checks the Quality and
Environmental policies and objectives for continuing
suitability.
QUALITY OBJECTIVE
Our objective is to satisfy all of our customers with quality
products and services.
QUALITY POLICY
We will Accomplish Our Objective through Customer
Satisfaction by Providing:
1. Make statement
2. Make another statement
PLANNING
QUALITY OBJECTIVES
The Managing Director and Operations Manager ensures
(established at relevant functions and levels within the
organization) that quality and environmental objectives and
measures are documented in a business plan, including those
needed to meet product requirements.
The Company’s Management Team annually reviews
business plan and revises, as appropriate, to encourage
customer satisfaction and overall growth of the organization.
The business plan includes short and long-term goals relating
to quality and environmental policy objectives, and defines
timeframes to achieve each goal. We also have methods to
track update and revise fall under the Continuous
Improvement Process.
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The quality manual documents the necessary processes that
define the planning process for quality/environmental
management system and objectives.
The Company benchmarks trends in quality; productivity,
efficiency, and effectiveness are, as information is available.
We accomplished Benchmarking formally and informally via
trade shows, reading material, customer feedback, and
charting of performance measures (Section 6).
Objectives may include the following possible measures
(Section 5):
Customer Satisfaction: Managing Director (Section 8)
Supplier Performance: Materials Manage (Section 7)
Quality/Environmental Systems Effectiveness: ISO
Management Representative (Section 8)
Overall Operational Efficiency and Manufacturing
Process Efficiency (Section 5 and 6)
Training Effectiveness and Employee Awareness: Human
Resource Director (HRD) with input from the Training
Manager (Section 6)
Product Performance: Program Manager (Section 7)
Effectiveness of Manufacturing Processes: Production
Manager (Section 7)
Product Quality: Quality Manager (Section 8)
Quality objectives – Supplemental: Top management utilizes
the management review process (Section 5) to define quality
objectives and measurements to include in our Business Plan
and used to deploy our quality policy. We base specific
measurable objectives on achievable performance within a
specified period, driven by the following objectives we strive
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to achieve as a Full Service Supplier (FSS) to the automotive
industry:
a) Achievement of Zero Defects and 100% on time
delivery performance. (Section 7 and 8)
b) Manage and control facilities, processes, quality systems
and personnel to consistently and cost effectively
produce products and furnish services that meet
customer needs (Section 7).
c) Develop and implement Advanced Product Quality
Planning (APQP) practices and procedures in
accordance with ISO/TS 16949:2002, including the
AIAG “Advanced Product Quality Planning and Control
Plan” reference manual, APQP-2, and associated
customer specific requirements documents. (Section 7)
d) Provide objective evidence that all supplied products
and services satisfy all AIAG Production Part Approval
Process (PPAP) requirements, PPAP-4¸ (Section 7) as
required including acceptable process capabilities for all
Special/Control Characteristics that have been
established. Note: In the absence of any specific
instructions, we will default to a level 3 PPAP
submission. (Section 7)
e) Utilize appropriate statistical techniques for on-going
process control and improvement as established in the
AIAG “Statistical Process Control (SPC)” reference
manual, SPC-3, and associated customer specific
requirements documents. (Section 8)
f) Be committed to continuous process improvement by
emphasising reduction of part-to-part variation and the
elimination of all waste. (Section 8)
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g) Conduct operations in conformance with, or to exceed,
all applicable environmental laws and regulations of the
jurisdictions in which we do business (Section 6).
h) Meet customer requirements by controlling and using
returnable packaging, of. (Section 7).
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The Operations Managing and
The Human Resource Director
The interrelationship of Top Management and other key
personnel is depicted our Organization Chart.
TOP MANAGEMENT
Members of Top Management are ultimately responsible for
the quality of The Company’s’ products and services since
they control the systems and processes accomplished work.
Top Management is responsible for Business Planning,
development and communication of our quality policy,
Quality/Environmental Systems Planning including the
establishment and deployment of objectives (Section 5), the
provision of resources needed to implement and improve
Quality/Environmental Systems and management reviews
(Sections 5 and 6).
MANAGEMENT
All managers are responsible for execution of the Business
Plan and implementation of the policy, processes, and systems
described in this manual. All managers are responsible for
planning and controlling Quality/ Environmental Systems
processes within their area(s) of responsibility, including the
establishment and deployment of operational level objectives
(Section 5), and the provision of resources needed to
implement and improve these processes. Managers also
conduct employee performance reviews (Section 6).
Management with responsibility and authority for corrective
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action promptly notifies employees of non-conformities
(Section 8). Management ensures the staffing of all
production shifts with personnel in charge of, or delegated
responsibility for product quality (Section 7).
EMPLOYEES
All employees are responsible for the quality of their work
and implementation of the policy and procedures applicable to
processes they perform. Personnel responsible for product
quality have the authority to stop production to correct quality
problems (Section 8).
MANAGEMENT REPRESENTATIVE
The Company has appointed Quality and Environmental
Management representatives for each system. The
management representatives have the responsibility and
authority to:
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The Environmental Management Representative is
responsible for documenting and responding to relevant
communication from external parties.
CUSTOMER REPRESENTATIVE
The Program Manager will ensure and address customer
requirements and will represent the needs of the customer
internal functions, from contract review through production
INTERNAL COMMUNICATION
The Company uses a variety of tools, including but not
limited to workplace meetings, memos, bulletins, new
employee orientation, and specific training sessions to
communicate internal information about the effectiveness of
our quality and environmental management system, and its
policies, objectives and significant environmental aspects.
We communicate information regarding Quality/
Environmental Systems processes and their effectiveness
through documented training (Section 6), the internal audit
process (Section 8), continual improvement, and corrective/
preventive action processes (Section 8), and regular formal
and informal communications as follows:
The ISO Management Representative posts information
on quality bulletin boards throughout the facility to
convey information regarding customer requirements,
and the status and importance of quality activities.
The Company uses internal audits (Section 8) to
reinforce or communicate appropriate information to
employees.
The Operations Manager posts information on safety bulletin
boards throughout the facility to convey information
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regarding the status of the Safety and Environmental
Management Program, and related statutory/regulatory
requirements. The Human Resources Department posts
information on employee bulletin boards throughout the
facility to convey information regarding employee benefits,
programs, involvement opportunities, and applicable
statutory/regulatory requirements.
All managers and supervisors, are responsible for establishing
internal communications as needed to convey to their
employees the relevance and importance of their activities;
typically this information is conveyed through production
team meetings and cross-functional improvement projects
(Section 8). Communications regarding how employees
contribute to the achievement of objectives, which we convey
and reinforce during employee performance, reviews (Section
6).
MANAGEMENT REVIEW
Top Management conducts formal review meetings at least
quarterly to ensure the continuing suitability, adequacy, and
effectiveness of our Quality/Environmental Systems in
accordance with procedures detailed in SOP 5.6. The
Managing Director or designee chairs the corporate reviews
and top management from all relevant functions attends.
(Section 8)
The Company record review results provide at a minimum,
evidence of achievement of quality/environmental objectives
and customer satisfaction. We retain meeting records.
(Section 5)
The Quality Manager ensures that review includes analysis of
actual and potential field failure and their impact on quality,
safety, and environment. The primary output of management
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review meetings are management actions taken (Section 8) to
make changes or improvements to our Quality/Environmental
Systems and the provision of resources needed to implement
these actions.
The Company holds review meetings at least monthly to
review plant specific data and process effectiveness
indicators, identifying opportunities for improvement and
corrective and preventative actions.
REVIEW INPUT
The management review meeting includes a review of our
quality policy (Section 5), all applicable requirements of the
QEMS, related performance trends, and opportunities for
improvement, follow-up actions from earlier management
reviews, results of self-assessments (Section 8), and strategic
or operational changes that could affect the QEMS.
At a minimum, corporate level, effectiveness and/or
efficiency improvement objectives (Section 5) documented in
prior management reviews (and/or specified in our Business
Plan) and reviewed for status and continuing suitability.
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REVIEW INPUT – SUPPLEMENTAL.
In addition, The Program Manager provides an analysis of
actual and potential field-failures and their impact on quality,
safety or the environment as an input to the management
review process.
REVIEW OUTPUT
At a minimum, outputs from management review meetings
include new/revised corporate level improvement objectives
and any related actions required for improvement of the
Quality/Environmental Systems and its processes,
improvement of product related to customer requirements,
and provision of resource needs. Per SOP 5.6, we record the
results of management review meetings and the ISO
Management Representative maintains the records.
RESOURCE MANAGEMENT
PROVISION OF RESOURCES
The Company, through the Management team,
determines its resource needs and provides the resources
to implement and maintain the quality management
system and continually improve its effectiveness, and to
enhance customer satisfaction by meeting customer
requirements.
Resource requirements identified during the Business Plan
Process, Quoting process, and advanced Quality/
Environmental Planning. We accomplish verification of
work through budget comparisons, capital expenditure
review, performance measurements, as well as through the
results of internal audits of the quality and environmental
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provided through our budgeting and other business
management processes including:
SUBJECT
Quality/Environmental Planning
Business Planning
Human Resource Planning
Plant, Facility, Equipment and other Infrastructure
Planning
Contingency Planning
Work Environment, and Safety Planning
Product Quality Planning (including Advance Product
Quality Planning)
Planning of Customer-related Processes
Product and Manufacturing Process Design and
Development Planning
Planning of Purchased Product (Materials, Services
and Vendors)
Production, and Service Provision Planning
Measurement Systems Planning (including the
conduct of MSA)
Measurement, Analysis, and Improvement Planning
(including the use of SPC)
Organizational Continual Improvement Planning
Manufacturing Process Continual
Improvement Planning
The MD, with input from other responsible managers,
monitors and measures overall operational efficiency
(including the cost of poor quality) and provides related input
and recommendations that may affect Quality/ Environmental
Systems effectiveness to Top Management for review and
action. (Section 5)
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HUMAN RESOURCES
GENERAL
The Company ensures that all employees who perform
activities that may affect product quality or have significant
impact on the environment have the appropriate training,
skills, experience and competence. We utilize a “mentor”
system for the first of four phases with an experienced
operator working with a new person and the work instructions
of the particular process. In the second phase, the experienced
person or member of management continues to observe the
new person. In the third phase, we deem the new person
“competent” to work on his or her own. Some persons may
move on to the fourth stage and we deem them an “expert”
allowing them to train others or assume other responsibilities.
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NEED DETERMINATION
Department managers and supervisors are responsible to
identify required training and competency for personnel in
their respective areas and to coordinate training and follow
through with evaluations for competencies. Our Training
Coordinator is responsible to analyze effectiveness of training
and competence, and update of hourly employee
Training/Competence Matrix records.
The Human Resource Department, with input from
responsible managers, evaluates and qualifies applicants for
specific job openings based on documented or demonstrated
competencies. Where possible, we help existing employees
qualify for new/changed jobs through the provision of
appropriate education and training, including on-the-job-
training (OJT).
TRAINING
Responsible managers identify training needs for their
employees and achieve competence of all personnel
performing activities affecting product quality. Personnel
performing specific assigned tasks are qualified, as required,
with particular attention to the satisfaction of customer
requirements (application of digitized mathematically based
data, e.g.).
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ON-THE-JOB-TRAINING
Responsible managers ensure on the job training (OJT) is
provided for personnel in any new or modified job affecting
product quality, including agency or contract employees.
Responsible managers ensure that employees are aware of the
relevance and importance of their activities and contributions
to the achievement of our objectives.
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PROVISION
We utilize the “employee performance review process” to
motivate employees to achieve individual or functional
performance objectives that support achievement of our
corporate objectives (Section 5). We use employee
performance reviews and the internal audit process (Section
8) to promote and assess the extent of quality and
technological awareness throughout our organization.
Responsible managers, officers, and supervisors re-evaluate
employee competencies and evaluate employee performance
against established objectives through our employee
performance review process.
EFFECTIVENESS
The Company evaluates the effectiveness of all actions taken
to meet competency needs. We evaluate provided training
through immediate feedback from the employee and the
manager, or supervisor who identified the training
requirement.
The responsible manager collects the documents for each
training event. Responsible managers monitor and measure
the overall training effectiveness and to meet competency
needs and provides related recommendations to Top
Management for review and action (Section 5).
EMPLOYEE AWARENESS
Through their activities and contributions, we ensure that our
employees are aware of customer requirements (Section 5 and
Section 5), the relevance, and importance achieving our
quality policy (Section 5) and objectives (Section 5). We
accomplished this through awareness training, employee
performance reviews (Section 6), and employee participation
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in our internal audit (Section 8) and improvement (Section 8)
processes.
RECORDS
We maintain appropriate records of education, training, skills,
and experience in accordance with provision of Section 4. The
Human Resources Department maintains employee
qualification and competency review records and annual
performance review results. The Training Manager maintains
records of all training completed.
INFRASTRUCTURE
The Company provides and maintains the infrastructure
needed to achieve conformity to product requirements,
including buildings, workspace and associated utilities;
process equipment (hardware and software as necessary); and
any supporting services that are needed, such as transportation
or communication.
We use a multi-disciplinary approach to develop plant,
facility, processes, and equipment. In addition, we detail
methods to evaluate and monitor the effectiveness of existing
operations in SOP 7.5.1.4 and SOP 5.6.
The Company prepared contingency plans to satisfy
customer requirements in event of an emergency such as
utility interruptions, labor shortages, and key equipment
failure and quality issues. (SOP 6.3.2)
The Plant Supervisor has overall responsibility for managing
our Facilities and Equipment Maintenance programs in
accordance with SOP 6.3; these programs include:
Facilities management, maintenance and repair
Housekeeping/custodial services management
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Process equipment management, maintenance and repair
Production tooling management, and
Transportation and material handling equipment
management, maintenance, and repair
WORK ENVIRONMENT
We provide employee benefits, job and schedule flexibility,
interesting work, and involvement of our employees in an
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empowered environment of continual improvement (Section
6). We engender total participation by involving employees in
internal audit (Section 8) and improvement (Section 8)
activities. The Human Resources Department has overall
responsibility for identifying, implementing, and maintaining
effective employee benefit and workforce involvement
programs.
The Operations Manager has overall responsibility for
identifying, implementing, and maintaining safety and
environmental management systems, processes and controls
needed to ensure product conformance and meet customer,
statutory or regulatory requirements. We monitor and improve
workplace safety, health, and ergonomics by following proper
manufacturing practices, and through safety team meetings
and training (Section 6).
Personnel safety to achieve product quality: We design and
carry out production processes to ensure product safety and
minimize potential risks to employees as may be identified
during development of design FMEAs (Section 7) and/or
process FMEAs (Section 7) and documented in work
instructions located in process areas (Section 7).
CLEANLINESS OF PREMISES
We provide and maintain a work environment in a state of
order, cleanliness, and repair consistent with the product and
manufacturing process needs (Section 6)
PRODUCT REALIZATION
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how the respective requirements will be met (See SOP 7.1
& SOP 7.2). This planning process is consistent with the
requirements of the ISO standards and sets the framework
for all Company processes of the quality/environmental
management systems.
2. For new projects, a cross functional team plans the
processes with consideration given to, but not limited to,
the following:
a. The quality/environmental objectives and
requirements for the product
b. Environmental aspects/impacts
c. Product special characteristics, including safety
characteristics
d. Error proofing for processes, facilities, equipment, and
tooling
e. The identification of any controls, processes,
equipment (including inspection and test equipment),
documentation, fixtures, training and skills needed to
achieve the required quality and environmental
objectives and targets, including the prevention of
pollution
f. Identification of required verification, monitoring,
measuring, inspection and test activities
g. Records are identified and kept as evidence that the
realization processes and resulting product meet
company and customer requirements per the quality
and environmental plans
h. Customer requirements and references to technical
specifications are to be included in the quality plan
3. The Company uses the methods in the APQP, SPC
PFMEA, and PPAP, MSA, and Control Plan manuals as
required.
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4. The quality plan and relevant work instructions clearly
define acceptance criteria and approved by the customer.
5. We maintain customer confidentiality for all products and
projects under development, and related product
information, including electronic data.
6. The Company assesses product and manufacturing
process changes that affect product realization. We
confirm defined activities to ensure compliance with
customer requirements. When we receive the approval for
any changes affecting customer requirements, we notify
the customer and validate changes before implementation.
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Production Part Approval Process (PPAP) (Section 7). The
APQP Team Leader implements the PPAP recognized by our
customers, PPAP-4; see SOP 7.1) in the absence of any
specific instructions, we will default to a level 3 PPAP
submission. We obtain PPAP approval prior to the first
production shipment of product (unless specifically waived by
the customer).
The APQP Team Leader ensures:
Submissions for part approval prior to the
implementation of changes, to determine the type of
quality re-certification required (PPAP documentation.)
Production following any change in process or method
of manufacture
Change of source for subcontracted parts, materials, or
services (e.g. heat treating or plating)
Product re-released after the tooling has been inactive
from volume production for twelve months or more.
ACCEPTANCE CRITERIA
Acceptance criteria is approved by the customer, where
required. For attribute data sampling, the acceptance level is
zero defects (Section 8).
CONFIDENTIALITY
We ensure the confidentiality of customer-contracted
products and projects under development and related product
information (Section 7).
CHANGE CONTROL
The Quality Manager obtains necessary customer approval of
quality plans, acceptance criteria, product, and/or
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manufacturing process, and all related changes that may affect
product realization. For propriety designs, impact of form, fit,
and function (including performance and durability) and
reviewed with the customer, so all effects can be properly.
When required by the customer, we perform additional
verification and identification requirements, such as required
for new product introduction, validation, and SOP 7.1.
(Section 7)
CUSTOMER-RELATED PROCESSES
Achieving our quality policy “to meet or exceed customer
requirements” requires that we determine, understand, and
consistently meet or exceed our customers’ requirements and
expectations, and that we establish effective communication
systems with our customers with regards to product
information, inquiries, contract or order handling and related
changes, and customer feedback, including complaints.
(Section 8)
DETERMINATION OF REQUIREMENTS
RELATED TO THE PRODUCT
The Company maintains documented procedures for quoting
and contract review and the coordination of these activities.
When a request for quote is received, it is processed according
to the Quoting Process to ensure that quality and
environmental requirements adequately define and document
considerations for recycling, environmental impact, and
identified characteristics (Section 7).
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safety and environmental regulations and requirements; and
any additional requirements determined by the Company.
ORGANIZATION MANUFACTURING
FEASIBILITY
The Program Manager confirms and documents the
manufacturing feasibility of proposed automotive products,
including risk analysis, and product design input and
manufacturing process design input in accordance with
customer-specific requirements governing the APQP/PPAP
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process detailed in SOP 7.1 in accordance with APQP.
(Section 7)
CUSTOMER COMMUNICATION
During the design and development planning the following
are determined and controlled: the design and development
stages, review, verification, and validation that are appropriate
to each design and development stage and the responsibilities
and authorities for design and development.
CUSTOMER COMMUNICATION –
SUPPLEMENTAL
The Information Systems Manager establishes/maintains an
ability to communicate necessary information, including data,
in a customer specified language and format, including but
not limited to computer-aided design (CAD) data and
electronic data interchange (EDI).
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initiatives, policies, and transaction sets comply with the
guidelines set forth by the AIAG and our key suppliers
mandate we have the capability to interface with us
electronically.
DESIGN PLANNING
The Program Manager serves as Design Team Leader for
tooling design projects for new/changed non-automotive
products; The Quality Manager assigns a qualified Quality
Engineer to service as APQP Team Leader for design projects
involving new/changed automotive products and related
manufacturing processes. The Design (or APQP) Team
Leader uses project management planning tools (available
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software etc.) to establish a Design Plan that identifies design
stages, fixed design reviews, scheduled verification and
validation activities.
MULTIDISCIPLINARY APPROACH
The Design (or APQP) Team Leader forms a Design (or
APQP) Team composed of design, manufacturing,
engineering, quality, production and other appropriate
qualified personnel to prepare for product realization,
through:
Development/finalization and monitoring of special
characteristics
Development and review of Potential Failure Mode
Effects Analysis (FMEA) including actions to reduce
potential risks per customer guidance, FMEA, and
requirements
Development and review of control plans
DESIGN INPUTS
The Product Engineer or Program Manager is responsible for
identification, documentation and reviewing all applicable
design inputs are for adequacy. These inputs include
functional and performance requirements; applicable statutory
and regulatory requirements and other requirements essential
for design and development. (See APQP Workbook Master)
(Section 7)
The Product Engineer or Program Manager is responsible for
ensuring that we identify, document and review all valid
design inputs. These inputs include functional performance
requirements, applicable legal and regulatory requirements
and other requirements essential for design and development.
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As designs and processes are developed, a document for
lessons learned is maintained which documents information
derived from previous similar designs. This information is
also reviewed as an input to new designs, where applicable.
Incomplete, unclear, or conflicting requirements are resolved
prior to the release of the final design.
We identify product design inputs, documented, and
reviewed, including:
a. Customer requirements such as special characteristics,
identification, traceability and packaging
b. Information from similar product experience including
field data and internal input and Competitor Analysis
c. Targets for product quality, life reliability, durability,
maintainability, timing and cost
We identify process design inputs, documented, and reviewed
including:
a. Product design output data (i.e., DFMEA)
b. Targets for productivity, process capability and cost
c. Customer requirements
d. Process design includes the use of error proofing
We use Advanced Product Quality Planning to indentify
Customer product and process special characteristics and
symbols to be included on FMEAS, Control Plans, and other
process documents as appropriate.
DESIGN OUTPUTS
The Design (or APQP) Team Leader ensures that design
outputs comply with the design input requirements; include
information needed for production and service provision;
include or reference acceptance criteria; indicate design
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characteristics critical to the safe and proper operation of the
product; and are approved before issuance:
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DESIGN REVIEW
During the evolution of each design project, the Design (or
APQP) Team Leader conducts design reviews as planned and
records results and any necessary actions. The Design (or
APQP) Team Leader uses input from those involved in the
review to propose a remedy for each identified problem.
MONITORING
The Design (or APQP) Team Leader monitors the design
project by defining, analyzing and recording measurements at
specified stages of design and reports summary results as an
input to management review (Section 5). Measurements may
include quality risks, costs, lead-times, and critical paths.
DESIGN VERIFICATION
We conduct design verification to ensure that the design and
development outputs have met the specified input
requirements. Records of verification results and any
necessary actions which we record on the DVP & R and
Program Open Issues.
Design Validation includes a review of field reports for
similar products, if applicable. Wherever practicable, we
complete validation prior to the delivery or implementation of
the product.
We conduct final validation testing to validate the final
product, design, and process. We perform Validation in
accordance with customer requirements, including program
timing, Production Part Approval Process (PPAP) for
customers requiring this program or other sample submission
programs as required.
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after process verification we submit the Product approval. It is
the responsibility of the Program Manager in cooperation with
the Quality Manager to ensure The Company submissions
meet functional, material, and appearance specifications as
required by the customer. Suppliers are required to follow The
Company product and manufacturing process approval
procedures and requirements.
We perform design validation on products that we produced
from production equipment and tooling wherever and to the
extent possible. The Program Manager keeps records of
required tests in the APQP documentation. If there needs to be
corrective actions, these we document these changes and keep
them in the ECN documentation.
DESIGN VALIDATION
The Design (or APQP) Team Leader ensures design
validation is carried out as planned (per the Design Plan) and
records results and any necessary actions. We perform design
validation to ensure the product or service resulting from
design efforts performs as intended for all specified or known
uses and applications. As applicable, the Design (or APQP)
Team Leader plans and carries out or oversees design
validation to ensure it is performed in accordance with
customer requirements, including program timing.
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absence of any specific instructions, we will default to a level
3 PPAP submission (Section 7).
PURCHASING
We work in partnership with our suppliers to ensure that
purchased products and services meet all applicable
requirements. The processes applicable to the planning,
acquisition and verification of all products and services that
affect customer requirements (such as sub-assembly,
sequencing, sorting, and rework and calibration services) are
defined in accordance with the policies outlined in this
section.
PURCHASING PROCESS
The type and extent of control applied to our suppliers and
purchased product is dependent upon the effect on subsequent
realization processes and their output, as well as consideration
of other characteristics including the type of product; the
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potential impact of the product on our processes, products, or
services; the results of supplier evaluations; and past
performance.
Purchased products are verified (Section 7 and 8) to ensure
conformity to specified purchase requirements.
REGULATORY CONFORMITY
We also verified purchased products or materials to ensure
conformity to applicable regulatory requirements.
Purchasing, Quality Control, and engineering work together
to ensure purchased products and /or services conform to all
specified requirements, including those from the customer.
We have documented Purchasing procedures.
CUSTOMER-APPROVED SOURCES
Where specified (by contract, customer engineering drawing,
or specification) we purchase products, materials, or services
from customer-approved sources.
We maintain a master list of approved suppliers to ensure we
only purchase product from The Company qualified sources
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or customer-approved sources. We then recorded the results
of evaluations and follow/up actions.
The Materials Manager monitors Supplier performance per
SOP 7.4.1 through one or more of the following indicators:
delivered product quality; customer disruptions including
field returns; delivery schedule performance (including
incidents of premium freight), and special status customer
notifications related to quality or delivery issues.
PURCHASING INFORMATION
The Materials Planning and Logistics ensure the adequacy of
specified purchase requirements prior to communication to
the supplier per procedures defined in SOP 7.4.2 and the
following policies. Purchasing information communicated to
our suppliers contains the appropriate data needed to clearly
and fully describe requirements for purchased materials and
services; including, where appropriate, requirements for
approval/qualification of product, procedures,
processes/systems, equipment; qualification of personnel; and
quality management system requirements.
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The Quality Manager plans and implements appropriate
sampling plans and other statistical techniques to verify
purchased product per Section 8. As applicable, the Quality
Manager documents and communicates the intended
verification arrangements and method of product release
related to verification activities performed at our suppliers’
premises.
CONTROL PLAN
The Quality Manager develops control plans at the system,
subsystem, component, and material level for the product
supplied, including processes producing bulk materials, as
well as parts. (Section 7):
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For pre-launch and production that takes into account the
design FMEA and manufacturing process FMEA
outputs
Ensures that productions across all shifts are staffed with
personnel in charge of, or delegated responsibility for
product quality
Tooling Management: The Company personnel maintain
control over any work that is outsourced. This is
responsibility if Program Manager.
The Quality Manager further ensures that control plans:
List the controls used for manufacturing process control
Include methods for monitoring of control exercised over
special characteristics defined by both The Company
and the customer
Include customer-required information, if any
Initiate the specified reaction plan when the process
becomes unstable or not statistically capable
Are reviewed and updated when any change occurs
affecting product, manufacturing process, measurement
logistics, supply sources or FMEA
WORK INSTRUCTIONS
The Production Manager prepares appropriate work
instructions for all employees having responsibility for
processes that impact product quality and employee safety
(Section 6). The instructions are derived from sources such as
the control plan and the product realization process and are
accessible to the work areas where they are needed.
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8). Work instructions governing set ups and related
verifications are developed and available, and use statistical
methods of verification where applicable.
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Tool design modification documentation, including
engineering change level
Tool identification, defining the status, such as
production, repair, or disposal
PRODUCTION SCHEDULING
The Production Manager schedules production to meet
customer requirements and our goal to achieve 100% on-time
delivery performance through a just in-time production
control.
INFORMATION
Information inputs to the process include both product
characteristics and appropriate work instructions containing
specific work methods and other pertinent information,
including process monitoring and verification instructions and
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criteria developed during product quality planning and
manufacturing process development (Section 7).
The Production Manager ensures that all appropriate
information including final product specifications, raw
material characteristics and the required product parameters,
is provided to production personnel throughout the product
and service provision process. We provided such information
through job schedules, plans, team meetings, work
instructions posted in areas as needed, and through job
specific information included in individual job packs.
WORK INSTRUCTIONS
The need for work instructions is dependent upon the
knowledge, skills, and abilities of our employees and the
complexity of their assigned work process. Engineering,
Quality and other technical personnel identify critical
production and service work will provide process sheets
included in the job pack or other information included in work
instructions posted in areas where needed.
EQUIPMENT
The Plant Supervisor ensures the suitability and availability of
all equipment, facilities, and tooling used for production and
service operations-(Section 6)
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MONITORING ACTIVITIES
The Production Manager, through Production Shift
Supervisors, ensures that production personnel monitor the
quality of the work and that employees understand the
procedures for reporting related problems and suspected
nonconforming conditions.( SOP 7.5.1) The Quality Manager
is responsible for planning and implementing in-process
inspections needed to ensure process control and product
quality. (Section 8)
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Defining criteria for review and approval of the
processes
Approval of equipment and qualification of personnel
Requirements for records; and revalidation
Use of specific methods and procedures
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We assign Incoming material part numbers. We must receive
incoming material with labels indicating the assigned part
numbers. We tag or label, incoming product received without
part numbers in Receiving. QC Receiving personnel are
responsible for verifying incoming material part numbers and
date coding as detailed in the Receiving and Inspection
Process.
Where contractually required, the Quality Manager plans for,
establishes, and maintains appropriate traceability records in
accordance with customer requirements. (Section 7)
CUSTOMER PROPERTY
Customer property includes customer-owned material, tools
(including returnable packaging), tooling (including
test/inspection tooling and equipment), and intellectual
property. The Company identifies, verifies, protects, and
maintains customer property provided for use or incorporation
into the product, by applying the same process controls as we
do to purchase product. (Section 7)
PRESERVATION OF PRODUCT
The Plant Supervisor is responsible for preserving the
conformity of the product during internal processing and
delivery to the intended destination including identification,
handling, packaging, storage, and protection. We design
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designated storage areas to prevent damage, deterioration, and
preservation of product pending use or delivery.
A FIFO inventory system is used and regular tracking of
inventory turns, we report at the management meeting.
Inventory turns and levels are goals defined within the
business plan.
Obsolete product is treated the same as nonconforming
product and is appropriately identified and segregated to
avoid using it for production.
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measuring devices and verify their capability of meeting such
requirements prior to use. In addition, the Program Manager
documents the method for confirming the ability of software
to satisfy the intended application (Section 7)
We define the processes employed for the on-going
calibration, control, and maintenance of monitoring and
measuring devices including their identification, location,
frequency/method of checks, uses/acceptance criteria and
what actions to take when results are unsatisfactory.
All monitoring and measuring devices that can affect product
quality we identify and calibrate at prescribed intervals
against certified equipment having a known valid relationship
to internationally or nationally known standards.
When we find monitoring and measuring devices out of
calibration (or when we do not know the calibration status),
we adjust or re-adjust as necessary and the validity of
previous measuring results and document; actions taken are
documented, including appropriate corrective actions to
remedy the situation and preclude its recurrence. (Section 8)
We maintain appropriate calibration records to document
results of calibration activities and suitable indicators are used
to show current calibration status. We used a number or other
identifier to provide traceability to the device calibration
record. (Section 4 & 7)
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CALIBRATION/VERIFICATION RECORDS
Records of the calibration verification activity for all gauges,
measuring, and test equipment needed to provide evidence of
product conformity to determined requirements, including
employee and customer owned equipment, include:
Equipment identification, including the measurement
standard against which the equipment is calibrated
Revisions following engineering changes
Statements of conformance to specification after
calibration/verification
EXTERNAL LABORATORY
The Quality Manager ensures external laboratories used for
inspection, test, or calibration services are either acceptable to
the customer or accredited to ISO 17025. (See SOP 7.6 for
calibration laboratories)
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MEASUREMENT, ANALYSIS AND
IMPROVEMENT
GENERAL
These sections describes how we define, plan, and implement
the monitoring, measurement, analysis, and improvement
activities needed to assure product and Quality/Environmental
Systems conformity and achieve continual
Quality/Environmental Systems improvement. These
activities include assessment of customer satisfaction, conduct
of internal audits, process monitoring and measurement, and
product monitoring and measurement.
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MONITORING AND MEASUREMENT
CUSTOMER SATISFACTION
Customer satisfaction is the reason we exist. This drives our
quality policy “to meet or exceed customer requirements”.
The Managing Director has overall responsibility for
identifying and reviewing customer requirements (Section 7)
and for monitoring and measuring customer satisfaction per
procedures contained in SOP 8.2.1:
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INTERNAL AUDIT
The Company’s internal audit results are critical inputs to aid
in assessing the effectiveness of our QEMS, in identifying any
opportunity for improvement, and in promoting awareness of
customer requirements and effectiveness of the Quality/
Environmental Systems.
QUALITY/ENVIRONMENTAL MANAGEMENT
SYSTEM AUDIT
The Company conducts system audits. The purpose of these
audits is to verify that the quality/environmental system
conforms to product realization arrangements and to the
requirements of ISO/TS16949, ISO 14001.
PRODUCT AUDIT
We conducted Product audits at appropriate stages of
production and delivery to verify conformance to all specified
requirements contained in the control plan (Section 8).
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The Quality/Environmental Systems process, function, or
quality system element under review is effective if it is
achieving the desired results or established objectives.
Responsible managers may also request that the audit be used
to gather “value added” data serving as input to aid in
monitoring, measurement, and improvement of
Quality/Environmental Systems processes and systems.
(Section 8)
SOP 8.2.2 defines the criteria, scope, frequency and methods
used for internal audits and define the responsibilities and
requirements for planning and conducting audits, and for
reporting results and maintaining records.
AUDITOR QUALIFICATION
Internal auditors are qualified to audit to ISO/TS 16949:2002
requirements (Section 6). We use qualified personnel to audit
areas for which they have no direct responsibility for the
activity. Audit checklists are prepared and used to aid in
ensuring audit consistency and comprehensiveness.
Management is responsible for the area-audited implement
and timely corrective action to eliminate detected non-
conformances and their causes, and initiate other appropriate
action in response to opportunities for improvement identified
by process participants or managers. We conduct follow-up
audits to verify timely and effective implementation of the
proposed action.
The ISO Management Representative maintains all internal
audit records, including internal auditor training records,
results of internal audits and related follow-ups; periodically
reviews internal audit results as well as progress towards
achievement of corporate level objectives aimed at improving
overall Quality/Environmental Systems effectiveness and
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provides related recommendations for review by Top
Management. (Section 5)
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instructions) are documented. Acceptance criteria (as well as
objectives for process capability, reliability, maintainability
and availability) and appropriate reaction plans are included
in control plans and/or job packs. For attribute data sampling,
the acceptance level shall be Zero Defects. (Section 7)
PROCESS MONITORING
Process operators per applicable instructions monitor
processes. Control plans and process flow diagrams are
implemented to ensure adherence to the specified
measurement techniques, sampling plans, acceptance criteria,
and reaction plans when acceptance criteria is not met.
(Section 7 and 8)
Production personnel follow documented reaction plans when
processes become unstable or no longer capable. The Quality
Manager then initiates a corrective action plan indicating the
timing and assigned responsibilities to assure the process
becomes stable and capable. The corrective action plan is
reviewed with and approved by the customer, and requires
application of a customer recognized or approved problem-
solving approach (Section 8).
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The scope of our product monitoring and measurement
system (SOP 8.2.4) includes receiving inspection, job set up
verification, in-process inspection, final inspection and test,
layout inspection and functional test, and special
consideration regarding monitoring and measurement of
appearance items.
RECEIVING INSPECTION
Incoming product is not used or processed until it has been
inspected or otherwise verified as conforming to specified
requirements in accordance with the control plan and/or
documented procedures. Methods used to verify incoming
product from the supplier; such as receiving inspection or
(SOP 8.2.4), evaluation by accredited laboratories; or source
inspections. (Section 7)
IN-PROCESS INSPECTION
Quality Control personnel perform formal in-process
inspections in accordance with the control plan and SOP
8.2.4. Production personnel in accordance with the applicable
control plan perform manufacturing process monitoring
(Section 7 and 8).
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RELEASE
We do not release products for further processing or delivery
until we have objective evidence that meet all requirements.
EVIDENCE OF CONFORMITY
We maintain test and inspection records for a minimum of
three years. These records include final inspection authority,
identify, and confirm that all critical parameters are in
accordance with established requirements and specifications.
Additionally, product samples are stored for a minimum of 3
years.
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APPEARANCE ITEMS
For parts designated by the customer as “appearance items”
The Company provides; appropriate resources, including
lighting, for evaluation areas for appearance items. We
maintain Masters for color, gloss, grain, & texture and
evaluation equipment in the QC laboratory. Personnel
responsible for making appearance evaluations are qualified
and competent to do so, including performance of color
eyesight testing. (Section 6)
IDENTIFICATION
Identification of nonconforming product originates from
inspection, internal testing, product audits or customer
complaints. Employees clearly mark or otherwise identify
nonconforming product or suspect material.
DOCUMENTATION
The Quality Manager or authorized Quality Control
personnel enter the nonconformance into the corrective
action system identifying the nonconforming product and lot
number if applicable, description of nonconformance, and
location where the nonconforming product is being held
pending further review or disposition. (Section 8)
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SEGREGATION
Nonconforming product is segregated pending evaluation and
disposition.
EVALUATION
The Quality Manager through authorized Quality Control
personnel, perform the initial evaluation of nonconforming
product in accordance with approved test and inspection
procedures. Where needed, Engineering, Production and other
technical personnel may become involved in the evaluation
and recommendation for disposition.
DISPOSITION
The results of the evaluation and resultant disposition
determinations are documented. Dispositions resulting from
the evaluation of nonconforming product may include rework
to meet specified requirements; re-grade for an alternative
application; use as is (under customer concession or other
required approval authority); obtain (from relevant authority)
a waiver of or deviation from requirements; return to supplier;
scrap or other disposal.
Suspect or rejected material is either clearly identified with
yellow Quality Hold tape or is stored in clearly marked
designated areas, depending on the nonconformity. The
Quality Control Manager has the responsibility to ensure
disposition of all suspect or nonconforming material within an
appropriate timeframe.
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PRODUCT RECALL
In the event we detect nonconforming product after delivery
or use has started, the Quality Manager notifies the customer
and initiates action appropriate to the effects, or potential
effects, of the nonconformity. Where appropriate, product
recall is initiated based on trace and recall data and records
(Section 7)
NONCONFORMANCE REPORTING
Records of the nature of nonconformities and any subsequent
actions taken, including concessions obtained, and maintain
them according to SOP applicable inspection and test
procedures. (Section 4)
CUSTOMER INFORMATION
It is the responsibility of the Quality Control Manager to
ensure that the customer is promptly informed in the event
that nonconforming product has been shipped.
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CUSTOMER WAIVER
According to the production Part Approval Process (PPAP)
manual, we obtain prior written customer approval whenever
the product or process is different from currently approved.
We maintain Engineering Approved Product Authorization
(EAPA) records, including expiration date or quantity
authorized, and label the carton of parts. The original or
superseding specs and requirements are complied with when
the authorization expires.
Non-conformance reports requested by the customer (usually
if/when a customer receives material or service that fails to
conform to applicable quality and delivery specifications) are
processed per customer requirements and the procedures
defined in SOP 8.3.
If placed on “containment status” (due to continued poor
performance and/or failure to achieve goals and objectives),
The Company will take all actions required by the customer,
and guidelines contained in SOP 8.3.
ANALYSIS OF DATA
We collect and analyze data from quality and environmental
system processes evaluate the effectiveness of the
quality/environmental management system. This helps us to
find opportunities for continual improvement of the
effectiveness of the quality/environmental management
system.
Analysis of this data provides information relating to
customer satisfaction, product conformity; characteristics and
trends of processes and products, and suppliers.
We report and compare with progress towards the overall
business objectives During Business Planning and
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Management Review processes, trends in data and
information. We use this information to develop priorities for
prompt solutions to customer-related problems, support status
review, decision-making, and longer term planning, and
compare with competitors and/or appropriate benchmarks.
When we notice negative trends during data analysis, we may
initiate corrective/preventative action.
We implement computerized information systems for timely
reporting of data related to product usage. (Section 5)
We use comparative Analysis and Use of Data Trends in
quality and operational performance with progress toward
objectives and we develop recommendations for improvement
and present them to Top Management for review and action
during management reviews. (Section 5)
CONTINUAL IMPROVEMENT
We implement Continual Improvement with the goal of
continually improving the quality/environmental management
system using the quality policy, quality and environmental
objectives, customer feedback, audit results, analysis of data,
corrective and preventive actions and management review.
Management Action Requests (MARs), Form 8.5-1, is used to
document improvement, corrective and preventive actions.
We prioritize and implement all management an action based
on data analysis (Section 8) and performs cost/benefit
analyses to identify and prioritize improvement actions.
Our Management Review Process assesses the overall
effectiveness of continual improvement program. (Section 5)
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Essentially, such actions are effective if the problems
corrected do not reoccur, potential problems identified do not
occur, and other improvement actions accomplish the desired
results or objectives. We use inputs to the management
review process to establish new or changed improvement
objectives and to initiate/prioritize additional improvement
actions. (Section 5)
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CORRECTIVE ACTION
It is the policy of The Company to strive to prevent problems
before they occur. The Company maintains a corrective
action system that provides for the identification, analysis,
and elimination of the cause of quality and environmental
problems in order to prevent recurrence.
The corrective/preventive action system utilizes documented
procedures, which define requirements for the review and
handling of customer complaints; non-conforming material
from suppliers; internal, customer or third Party Audit non-
conformities; returned products; internally recognized product
or process non-conformities or potential non-conformities;
and environmental non-conformities, including external party
communications. See SOP 8.5.2 which describes the 8D
methodology we use internally. If a customer requires another
format, we do as they wish.
The procedures also define requirements for determining:
The causes of non-conformities and potential non-
conformities
Evaluating the need for action to prevent occurrence or
recurrence
Determining and implementing action needed, including
error proofing
Documenting results of action taken and reviewing
action taken SOP 8.5.2.
We analyze Non-conformities relating to customer returns
from assembly plants, engineering facilities, and dealerships
in a timely manner and the results are. These records are
available to the customer upon request and we follow
corrective action procedures to prevent recurrence.
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We consider the size and effects of the nonconformities when
corrective/preventative actions are taken.
There is a defined problem-solving process used in all plants.
When external non-conformances occur, The Company
responds in the problem-solving format prescribed by the
customer.
We apply corrective actions and controls to similar processes
and products, when appropriate. When we implement a
process change, procedures, policies, we change work
instructions as appropriate.
We conduct follow-ups (through the internal audit process
(Section 8) to ensure that we take effective corrective action
appropriate to the impact of the problem encountered. Results
of this analysis and related recommendations presented to Top
Management for review and action during management
reviews. (Section 5)
PREVENTIVE ACTION
Data from internal audits, customer feedback, employee
suggestions, and other appropriate data is collected and
analyzed (Section 8) to identify the actions needed to
eliminate the causes of potential problems and thereby
prevent their occurrence. Investigating and eliminating the
root cause of potential failures is a critical part of our
continual improvement process. We consider our preventive
action system effective if we avoid potential losses. Results of
this analysis and related recommendations and present them
to Top Management for review and action during
management reviews. (Section 5)
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ENVIRONMENTAL MANAGEMENT SYSTEM
ENVIRONMENTAL ASPECTS
The Company has identified the environmental aspects of its
activities, products and services that it can control and
influence and has determined those that have, or could have, a
significant environmental impact. We identified these
significant environmental aspects and their associated impacts
during the Initial Environmental Aspects Review.
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OBJECTIVES/TARGETS AND ENVIRONMENTAL
MANAGEMENT PROGRAMS
The Company identifies environmental objectives and targets,
and establishes action plans and programs for achieving these
objectives, as described in the objectives, targets and action
plans establish them at each relevant function and level within
the organization.
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The Company shall document procedures to cover situations
where the absence of such procedures could adversely affect
quality or have a significant environmental impact.
EMERGENCY RESPONSE
When appropriate, specific emergency response instructions
are prepared to allow rapid and effective response to
environmental incidents. Procedures provide general
guidelines to follow in the event of an environmental accident
or incident and references appropriate emergency response
instructions, where they exist.
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PROCEDURES
This booklet contains sample procedures.
They are very generic in nature.
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DOCUMENTATION
REQUIREMENTS
SOP 4.2
1.0 Purpose
This procedure addresses the maintenance of quality
documents pertaining to customer requirements. Quality
receives, prepares, revises, reviews, approves, and
systematically issues documents in a controlled manner.
2.0 Application
To maintain designated secured locations for original
policy, procedure, and instruction elements, drawings,
and specifications.
3.0 Definitions
Not applicable
4.0 Responsibility
The Process Owners/Area Managers are responsible for
controlling issuance and maintenance of quality/and
environmental-related policies, procedures, and operator
instructions.
One level above the author will be an approver for
reviewing and approving companywide policies,
procedures, and operator instructions for original release
and the release of changes.
The Program Manager and/or designee are responsible
for controlling issuance and maintenance of drawings.
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Department/Plant Supervisor are responsible for
controlling issuance and maintenance of associated
manuals and data within their area of responsibility as
required, Reference 6.0.
The responsible Department ensures that designated
personnel receive approval, initial issue, and
amendments of all documents and data relating to the
requirements of the quality system, and for the recall of
obsolete documents. The responsible Department
ensures availability of appropriate documents at all
locations where the performance of operations affect the
quality system.
The Administrator will maintain a master list of quality-
related documents.
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Where practical, the revision history identifies the
changes.
The quality department distributes a copy of the new or
revised policy, procedure, or instruction according to the
Quality Policy Manual, Procedure Manual, and Operator
Instructions Distribution List. Upon receipt of the new
or revised policy, procedure, or instruction, the recipient
updates the manual.
All documents used during, or forms generated before
the revision process shall be considered ‘grandfathered’,
acceptable to use ‘as is’ due to unavailability of revised
forms or unacceptable costs which would be incurred by
disposing of unused forms.
Revision History
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CONTROL OF DOCUMENTS
SOP 4.2.3
1. Purpose
2. Application
3. Definitions
4.0 Responsibility
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The Quality Manager and/or designee is responsible for
retaining master copies and assuring current revision
level of the AIAG reference manuals:
Advanced Product Quality Planning & Control
Plan
Fundamental Statistical Process Control
Measurement Systems Analysis
Potential Failure Mode and Effects Analysis
Product Part Approval Process
Quality System Requirements ISO 9000 or TS
16949
Environmental Mgmt. System, ISO 14001
The Program Manager is responsible for a timely review
of customer drawings and specifications. The PM has 10
business days of receipt to document the receipt of
drawings and maintain the engineering standards
according to the Drawing Control Procedure and
Engineering Change Process.
The Program Manager is responsible for receiving,
reviewing and retaining CAD/ Math data, Instructions
and Test Procedures are available.
The Plant Supervisor is responsible for ensuring current
instructions are available at all work instructions.
Department Managers are responsible for creating,
approving, and maintaining their individual department
work instructions.
All Department Managers listed above are also
responsible for making sure distributed and or retrieving
and replacing obsolete copies with the latest revision.
Both the person receiving a copy of a new or revised
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document and the person distributing the document are
responsible for ensuring the identification and/or
disposition of obsolete copies.
The Plant Supervisor is responsible for ensuring the
maintenance of records for Total Preventive
Maintenance activities.
The Program Manager is responsible for ensuring all
levels of documents and subordinate documents (such as
control plan, first piece, and in-process and operator
instructions) and that they agree with each other.
Department Managers are responsible for reviewing
all of their applicable documents within their
departments at a minimum of annually to insure
relevance and conformance.
Revision History
Page: 87
CONTROL OF RECORDS
SOP 4.2.4
1.0 Purpose
This procedure provides a method of maintaining
quality records consisting of identification, collection,
indexing, filing, storage, and disposal.
2.0 Application
This procedure applies to all departments responsible for
the maintenance of quality records.
3.0 Definitions
None
4.0 Responsibility
Each Department Manager is responsible for records
their department creates and for their maintenance,
protection, availability, and disposal.
The Quality Manager is responsible for ensuring the
proper retention of production part approvals, quality
performance records, internal quality system audits, and
management review.
The Program Manager and/or designee are responsible
for ensuring the proper retention of appropriate tooling
records. This is inclusive of all prints.
Accounting department and the Materials Manager are
responsible for ensuring the proper retention of
subcontractor purchase orders and amendments.
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The Materials Manager and Accounting department are
responsible for ensuring the proper retention of
customer related purchase orders and amendments.
6.0 Procedure
The responsible personnel and/or departments ensure
the validity and completeness, and determine the filing
and storage method (for retrieving and preventing
damage) and the retention duration (conforming to
TS-16949 requirements) for quality records. The
retention duration listed is a minimum retention. We
might retain the records longer for reference at the
discretion of the responsible party. The status of
archived records is determined and appropriate records
are disposed of annually.
The Quality Department retains superseded part
documents used for new part qualification.
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The Quality Department ensures quality records are
available for evaluation by the customer for the stated
period.
Obsolete documents, other than production part
approvals, tooling records, purchase orders and
amendments, we shall maintain them for the length of
time established by the corresponding Department
Manager and in accordance with minimum customer
requirements.
Revision History
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MANAGEMENT REVIEW
SOP 5.6
1.0 Purpose
The purpose of this procedure is to provide for a system
and instructions, and to assign responsibilities for
scheduling, conducting, and recording management
reviews of the quality management system.
2.0 Application
This procedure applies to all activities comprising the
quality system, and in particular, those named in Section
4, Review Input, of this procedure.
3.0 Definitions
None
4.0 Procedure
Frequency and Scheduling
Quality performance and the quality management
system and reviewed at least once a year. We conduct
the annual review in March.
For the first two years (i.e., through the maturation
phase of the quality system), management reviews are
conducted twice a year. We conduct the additional
review in September. In response to changing or special
conditions and events, the Operations Manager may call
for unscheduled extraordinary reviews.
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Attendance
The Quality Manager chairs the Management Reviews
attended by Management, Engineering, Production, and
Purchasing.
Those managers who are unable to attend shall receive
minutes of the review meeting and, after reviewing the
minutes, may submit their input and comments to the
Quality Manager. No more than one manager may be
absent from the meeting. The Operations Manager and
Quality Manager must always attend.
Agenda
The agenda for management review meetings covers at
least all items listed in Section 4 of this procedure. We
document the agenda on the cover page of the
Management Review Report.
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delivery performance, supplier quality performance, and
productivity data.
Edit the scope of the quality performance data as
appropriate, and coordinate with ISO/TS 16949 Element
8.4- Analysis of Data.
Corrective and preventive actions:
Quality presents the most important corrective and
preventive actions implemented through the period, and
the status of pending actions.
Customer feedback and complaints
Customer Service presents summaries of customer
feedback and customer complaints, including analysis of
trends.
Internal quality audits
Quality presents results of internal quality system audits.
This includes summaries of results for the cycle, the
frequency of audit findings against particular elements
of the quality system and discussion of significant
findings.
Changes and quality system planning
Quality highlights any product, process, capacity, or
other operational or organizational changes that affect
the quality system and proposes specific actions to
update or modify the system in response to these
changing circumstances.
Recommendations for improvement
Quality concludes the input phase of the review with
recommendations for improvement.
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In addition to the topics listed above, the management
review may also consider such issues as cost of quality
and non-quality; integration of the quality system with
other operations and activities; market and customer
response to the quality effort; and any other such issues
related to the quality management system.
Following each presentation, the participants discuss the
issues, compare their status and performance with
preceding periods, and identify areas where
improvement is required.
5.0 Quality objectives and quality policy
An important role of management reviews is to establish
quality objectives and to review progress toward
achieving the objectives and fulfilling the quality policy.
Quality objectives are established to improve
performance and/or the quality system and thus fulfill
the quality policy and other organizational goals and
aspirations.
At the end of the meeting, Quality presents the status of
quality objectives established by the previous review
(those objectives are documented on the title page of the
Management Review Report); and records their status in
the Status Next Management Review column.
When an objective is not achieved, the participants
decide whether to drop the objective, reduce its target
value, or extend the target due date.
We carry any quality objectives into the next period and
any new objectives established by the review meeting
and document in the Quality Objectives Matrix on the
title page of the Management Review Report.
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We review the principal quality policy to ensure its
continuing suitability. The policy is changed when the
goals expressed in the policy have been achieved, or
when changes within or outside the company render the
policy inadequate or inappropriate.
6.0 Management review output
Improvement of the quality management system,
Improvement of quality performance, and
Improvement of products and/or services to better
meet customer requirements and increase customer
satisfaction
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We identify resource needed for implementing
improvement actions These include assignment of
responsibility, time frame, and allocation of human,
equipment, technical knowledge, and other necessary
resources.
7.0 Records
Management review records must be as comprehensive
as possible. They will be the sole evidence that the
agenda of the review was completely covered, and
concluded the review with appropriate decisions and
actions.
We document the Management Review output in the
Management Review Report based on form MRR 5.6.1.
The report is prepared by the Quality Manager and is
distributed to the attending and, if any, absent
participants. Operational Procedure SOP 4.2.4, Control
of Records The location, and retention period for
management review records.
8.0 Referenced Documents
5.6.1 Management Review Report Form
SOP 4.2.4 Operational Procedure, Control of Records
SOP 8.5.2 Operational Procedure, Corrective and
Preventive Action
9.0 Associated Records
Management Review Report: Record of the
management review meeting, to include presented and
discussed topics and issues; conclusions, policies and
changes; and any actions initiated to implement the
conclusions and policies. Management Review Report
Documented using form FO-MRR-5.6.1,
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Quality Objectives Matrix:
We document Record of established quality
objectiveson the title page of the Management Review
Report (MRR 5.6)
Revision History
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COMPETENCE AWARENESS &
TRAINING
SOP 6.2.2
1.0 Purpose
The system described in this section is used to ensure
that all personnel performing activities affecting quality
shall have their training needs identified and, as
appropriate, the training provided.
2.0 Application
The scope of this procedure incorporates the training of
all employees performing quality related activities.
3.0 Definitions
Not applicable
4.0 Responsibility
Job Description
Each position has a written job description maintained
by the Human Resources Department. Each job
description identifies the competence level/ education,
skills appropriate required for the position.
Training Records
Hourly Employees: Records of hourly training needs
and training received by active employees performing
activities affecting quality shall be maintained by the
Human Resource Department. Each hourly employee
has an individual training record, which the Human
Resource Department maintains. These records include,
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but are not limited to, training matrices and copies of
training certificates.
Salary Employees: Human Resource Department shall
maintained records of salary training needs and training
received by active employees performing activities
affecting quality. Each salary employee has an
individual training record, which the Human Resource
Department maintains. These records include, but are
not limited to, training matrices and copies of training
certificates.
Evaluating Training Needs
All employees (salaried and hourly) must complete the
specific orientation program administered by the Human
Resource Department. We inform personnel whose
work affects quality about the consequences to the
customer of nonconformity to quality requirements. All
employees have training in awareness, relevance, and
importance of their activities and how they contribute to
the achievement of our overall quality objectives. The
employee’s manager/supervisor in the performance
review process determines individual training needs.
Safety Training
All employees receive safety training
Specialized Training
Employees requiring specialized training in areas
affecting quality shall receive the training needed per
job description.
Evaluating Training
The Human Resource Department continually assesses
the training courses offered internally. They evaluate
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content of the courses through a training feedback and
evaluation form, and give an assessment test (if
applicable) upon completion of the course.
6.0 Procedure
Identify training needs.
The Company employees and their manager/supervisor
shall review the employees training status to determine
training needs. This review occurs concurrently with the
employee’s performance evaluation or upon need.
Provide Training
One or more of the following provides formal training:
Identified The Company Trainers
Professional / Industry Organizations or Societies
Local Community and Trade Schools
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College and University Sponsored Classes
On-The-Job training is provided for all personnel,
including contract or service personnel, in any new
or modified job.
Determine Effectiveness of Training
One or more of the following determines training
effectiveness:
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CONTROL OF NONCONFORMING
PRODUCT
SOP 8.3
1.0 Purpose
This procedure provides a method to control
nonconforming material at any location in the S Group
and to eliminate its potential for unintended use or
delivery.
2.0 Application
This procedure applies to, but is not limited to,
unidentified or suspect material, in-house rejections,
customer rejection / returns or material received from
a supplier.
3.0 Definitions
Nonconforming Product: Material (e.g., resin,
purchased components, work-in-progress, etc.) that
does not meet established parameters (e.g., melt flow,
dimensions, visual, etc.)
4.0 Responsibility
The Production Supervision and Quality Department
are responsible for following documented procedures
and work instructions for product that does not
conform to specified requirements. It is clearly
(visually) identified and quarantined or segregated to
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prevent inadvertent use or installation. Material is
reviewed and disposition is determined by
management and quality. The Quality Department is
responsible for maintaining and analyzing data from
NC material activities.
The Program Manager/Production is responsible for
managing the customer authorization of products or
processes and the procurement of a deviation or
concession, including materials and services provided
by vendors, that differ from those currently approved
according to the Production Part Approval Process
Manual. This managing includes the procurement of a
deviation or concession from the customer if changes
to the product differ.
The Quality Manager is responsible for notifying the
customer of non-conforming material found after
shipment or use has started. The Quality Manager will
take Actions such as stock returns and replacement,
sorting or even sending a company representative to
their site to protect their interests.
6.0 Procedure
When finding nonconforming material, the Quality
representative or production supervisor identifies the
container(s) with an initial Material Concern Report. (If
material is part of an accumulation, issue a Material
Concern Report at the time of occurrence)
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We move non-conforming material to the Quarantine
Area and a member of the quality department or
Production Supervision, up to the disposition section,
completes the Quarantine Area Record.
The Production Supervision and Quality Manager
determine the disposition of the non-conforming
material and record it on the Quarantine Area Record.
Production personnel complete sort or rework. Quality
or a member of management will provide written
instructions to the employee conducting these activities.
There are four possible determinations of inspected
product:
Acceptable Product – green check mark
Acceptable Product - some rework necessary
with written instructions & records.
Unacceptable Product (placed in red “SCRAP”
container / on rack)
Questionable Product (QA disposition required)
Quality disposes of questionable product and records the
final counts and outcomes. No rework shall be visible
on the exterior of the product.
A Quality representative records the results of the
inspection and rework on the Material Concern Report
listing the method of rework, number of acceptable/
unacceptable parts, date, employee responsible for
reprocessing, etc.
The designated Quality Representative re-inspects the
material. Remove Conforming materials from the
container and returned to production flow. Scrap
Nonconforming materials or reworked accordingly.
Record Scrapped material in the Scrap Log and the
Material Concern Report.
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Identify, as required by the customer, all material
shipped under a customer concession or deviation will
be. Maintain Records of the quantity and expiration
date.
Revision History
Page: 105
CORRECTIVE AND PREVENTIVE
ACTION
SOP 8.5.2/8.5.3
1.0 Purpose
This procedure provides a systematic means in which
quality problems will be eliminated.
2.0 Application
This procedure applies to all quality problems, including
internal rejections, problems from subcontractors and
customer complaints.
3.0 Definitions
Not applicable
4.0 Responsibility
It is the responsibility of the Quality Manager to manage
the corrective/preventative action. The format utilized
will be an 8D, unless otherwise directed by the
customer.
The Top Management Team is responsible for analysis
of customer-rejected material.
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6.0 Procedure
An immediate (possibly temporary) fix is developed and
implemented with documentation, within twenty-four
hours of the receipt of the notice of concern.
We inspect and inventory all suspect parts. The quantity
checked, the quantity defective, and disposition of stock
are determined and recorded.-
If future shipments are to be certified, Manufacturing,
Quality, and the customer (if applicable) must establish
a method and duration.
The root cause of the problem is established and
documented after the initial write up.
Corrective/Preventative action reports must be complete
through interim corrective action within three days of
issuance. A team will determine permanent corrective
action within 7 days of issuance. The corrective action
team determines the period to verify the effectiveness of
the corrective action is to be by. The team will utilize
mistake-proofing methodology to the degree appropriate
to the magnitude of the problems and commensurate
with the risks encountered.
We monitor the corrective action for thirty days to
assure that the action taken has been successful. We use
Statistical methods (i.e. diagrams, x-bar and r charts,
etc.) when applicable. We review all corrective actions
during management review meeting.
If the action is successful, appropriate documents
(procedures, work instructions, etc.) are updated to
permanently implement the changes required by the
corrective or preventive action.
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We retain all forms used in the corrective and preventive
action procedure for active life of the product for
reference to prevent reoccurrence.
Analysis of customer returned rejects begins upon
receipt of the defective material. We will make records
of the analysis available upon request. If a corrective
action is initiated because of the analysis will be tracked
through the corrective action format.
We initiate Preventive Actions because of, TPM
activities; lessons learned follow up, the APQP process,
Lean activities, or technology changes. We track
preventive actions on the Preventive Action Log.
We review preventive actions during regular
management review meetings.
Revision History
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Work Instructions
This booklet contains sample Work
Instructions. They are very generic in
nature.
Page: 109
WORK INSTRUCTIONS
WI-SB-5.2.2
Important General Safety Notes
PPE:
Safety glasses
Gloves
Important General Notes
Setup includes:
Press
Carpet Cutter
Over Bend fixture
Check Fixture
Final Pack Container
Stage Material for production:
1. Material handler brings material to conveyor and setup in
proper position for conveyor load
2. Material handler brings carpet to the press to be loaded
onto carpet cutter
3. Provide shipping container
4. Two frames are required
Process:
1. The material is automatically loaded onto conveyor and
into oven while the operator prepares the carpet for
insertion into the press
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2. The operator uses the controls to roll out the carpet long
enough to place the tenor frames on the carpet
3. Attach both tenor frames to the carpet and cut the carpet
between them
4. Raise carpet to the cutter and cut the carpet just above the
tenor frames
5. Place the both tenor frames central over the cavities (one
tenor frame per two cavities)
6. The operator cycles the press by pressing the two black
palm buttons simultaneously
7. When the press finishes its’ cycle, the operator removes
the parts and the left over material
8. The operator then places the part on over bend fixture and
the waste material into the compactor and presses the
green palm buttons simultaneously
9. The quality inspector performs 1st piece inspection, at
beginning of shift, and after the removal of the part from
the over bend fixture
10. The operator then places the finished parts into a shipping
container
11. When the container is full, the operator calls the material
handler to remove the container and bring an empty one
12. The material handler puts a shipping label on container
and moves the container to the inspection holding area
13. Part inspection
14. Pack and label
Revision History
Page: 111
WORK INSTRUCTIONS
WI-DL-6.2.2
General Safety Notes
PPE:
Safety Glasses
Kevlar Gloves
Kevlar Sleeves
Knife
General Notes
Setup includes:
Page: 112
Provides shipping containers as required during
the shift
Process:
1. The operator uses pre-cut carpet and the operator attaches
the tenor frame to the carpet
2. The operator raises the carpet to the cutter and cuts the
carpet just above the tenor frame
3. The operator then places the tenor frame central over the
tool
4. The operator cycles the press by pressing the two black
palm buttons simultaneously
5. When the press finishes its’ cycle, the operator removes
the parts and the left over material
6. The operator then places the waste material into the
compactor
7. The operator inspects the part to verify 15 holes, one slot,
and 3 additional cutouts are clean with no slugs or fabric
strings or debris. If holes, slots, or cutouts are not punched
clean, follow Rework Instruction.
8. The operator burnishes the part edges of extra fuzz (if
necessary).
9. The quality inspector performs 1st piece inspection at
beginning of shift (If needed follow SOP 8.3 –
Nonconforming product), and records the information
10. The operator then places the finished parts into a shipping
container to packaging specifications
11. When the container is full, the operator has the material
handler to remove the container and bring an empty one as
needed
12. The material handler puts a shipping label on container
and moves the container to the inspection holding area
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13. The quality inspector performs part inspection and looks
for (see boundary sample):
Correct Color
No Forming Flaws (I.E., Excess Carpet, Carpet
Wrinkles)
Clean Trim Edge – No Fuzz Or Debris
Hole Clean – No Slugs
Cut or punched clean Slots and any additional
cutouts.
Overall Appearance Good
14. The quality inspector records the findings (If needed
follow SOP 8.3 – Nonconforming product)
15. The quality inspector also checks for container quantity
and correct label
Rework Instructions:
If the tool in the press does not punch the required holes in
the S197 Deck Lid remove the part to designated rework
area.
Rework the part by manually punching the holes using
correct size punch 3/16 for the two holes on each side of
the release trunk slot and 5/16 for the remaining holes.
Revision History
Page: 114
MANAGEMENT REVIEW FC-MR-5.6
Page: 116