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TABLE OF CONTENTS
Quality/Environmental Manual ......... 4
Documentation Requirements .......... 93
Control of Documents ...................... 96
Control of Records ......................... 100
Management Review ...................... 103
Competence Awareness & Training 111
Control of Nonconforming Product . 116
Corrective and Preventive Action .... 120
Work Instructions ......................... 124
Work Instructions ......................... 127
Management Review FC-MR-5.6 .... 131
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QUALITY/ENVIRONMENTAL MANUAL
SOP 4.2.2
1. ScopeGeneral
The Company is a design-responsible supplier of (name
your product here). Our products (name your market
here) and therefore the quality and environmental
management system adhere to the current ISO/TS 16949
and ISO 14001 standards, andThe Companys quality
and environmental policies.
The Company has based the Quality Environmental
Management System described in this manual to
demonstrate our capability (see Section 5) to provide
products and services that meet customer and applicableregulatory requirements, and to operate with increased
effectiveness and efficiency with the overall aim of
enhancing customer satisfaction consistently.
We developed Quality/Environmental Systems in
accordance with the following four additional types of
documents containing recommended automotive industrypractices, examples, illustrations, and explanations, to
smooth the progress of continual improvement by
emphasizing defect prevention and the reduction of
variation and waste:
y International Automotive Task Force (IATF)Guidance to ISO 9001 and all related documents
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Status reports on actions from previous Management
Reveiws
Identification of any stratigic or operations changes
that could affect the SystemIdentification of any policy issues requiring review
Status reports on progress towards meeting specific
improvement objectives:
y Customer Satisfactiony Supplier Performancey Overall System effectiveness including evidence
of repeat audit findings or other repeat problems
y Overall operational effedciency including anevaluation of the cost of poor quality
y Manufacturing process effectivness and efficiencyincluding performance against customer specified
(or other targets for productivity, process
capability and costy Overall product performance including an
analysis of actual and potential field failures and
their impacton on quality, safety, or the
environment
y Oerall product qualtiy including performanceagainst customer spcified (or other) targets related
to product qualityy Overall effectiveness of training completed including
skills training, on-the-job training, and employeeawareness and effectiveness of employee motivation
y Recommendations for improvement and plans
Page: 5
y Quality System Assessment Checklist to ISO 9001and all related documents
y ISO/TS 16949 Automotive Certification Scheme-Rules for Achieving IATF Recognition and all
related documents
y ISO 14001 Environmental Management SystemsRequirements and all related documents
y Customer-specific requirements and guidancedocuments
Company Background
The Company, established in XXXX, and the
headquarters is located at XXX Some Street, City, State,
zip.
The Company currently supplies to the followingmanufacturers:
y XXXX,y XXXX
Where possible we integrated the quality system and the
environmental management system to ensure that
operations are cost effective and environmentally
responsible.The Companys Quality and
Environmental Policy are available upon request.
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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 therequirements not applicable to our organization and provides a brief
narrative justifying their exclusion from the scope of our
Quality/Environmental Systems:
Exclusion Table
Clause Exclusion Justification
2. Reference DocumentsThe following external documents contain provisions,which, through reference in this manual, constitute
provisions of our Quality/Environmental Systems:
y ISO 9000:2005, Quality management systems Fundamentals and vocabulary
y ISO 9001:2000, Quality management systemsRequirements
y ISO 9004:2000, Quality management systems Guidelines for performance improvements
Page: 131
MANAGEMENT REVIEW FC-MR-5.6
Assess Overall
System Effectiveness
Monitor Objedctives and
Operations
Plan & Schedule
ManagamentReview
Meetin
Significant
Impact on
System
Analyze Results & Trends
Issue Management
Review Agenda
Prepare Management
Review Inputs
Issue Management
Rewview Minutes
Review Inputs & Develop
Outputs
Monitor
Implementation of
ActionsResulting
from Management
Review
Assess Process for
Effectiveness
Action to improve Effectiveness
of the System & its processesActionss to improve products
Actions to provide nedded
resources
New or revised improment of
objectives
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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: 7
Customer Specific Requirements:y ISO/TS 16949:2002, Quality management
systems particular requirements for theapplication of ISO 9001:2000 for automotive
production and relevant service part
organizations
y CSR-Ford, Ford Motor CompanyCustomer-Specific Requirements for Use with ISO/TS
16949:2002
y CSR-GM, General Motors Customer SpecificRequirements - ISO/TS 16949:2002
y CSR-DC, DaimlerChrysler (Chrysler Group)Customer-Specific Requirements for Use with
ISO/TS 16949:2002
Customer Reference Manuals:y APQP-2, Advanced Product Quality Planning
& Control Plan (APQP)
y FMEA-3, Potential Failure Mode and EffectsAnalysis (FMEA Third Edition)
y PPAP-4, Production Part Approval Process(PPAP Fourth Edition)
y SPC-3, Statistical Process Control (SPC)Note:
1. The SPCReference Manual, SecondEdition, has an improved flow and
2. Reinforces the need for a systemicapproach to analysis of variation in data
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3. Addresses additional control chartmethods and tools
y MSA-3, Measurement Systems Analysis(MSA)
y TS-QSA2, Quality System AssessmentChecklist, Checklist to ISO/TS 16949:2002
TS-GS, IATF Guidance to ISO/TS
16949:2002
3. Terms and DefinitionsOur Quality/Environmental Systems uses the same
internationally recognized terms, vocabulary, and
definitions given in ISO 9000 as supplemented by
terms defined in ISO/TS 16949:2002, Section 3.
Acronyms, terms, vocabulary, and definitions unique
to our organization, customers, industry, and region
and referenced throughout ourQuality/Environmental Systems are contained in
Appendix A, Terms and Definitions.
4. Quality Management SystemGeneral Requirements
Top Management is responsible to define theorganizations quality and environmental policy and
ensure that it is documented, communicated, and
understood throughout the organization.
Management review meetings, include the Quality and
Environmental policies and objectives for continuing
suitability.
Page: 129
9. The quality inspector performs 1st piece inspection atbeginning of shift (If needed follow SOP 8.3
Nonconforming product), and records the
information
10.The operator then places the finished parts into ashipping container to packaging specifications
11.When the container is full, the operator has thematerial handler to remove the container and bring an
empty one as needed
12.The material handler puts a shipping label oncontainer and moves the container to the inspection
holding area
13.The quality inspector performs part inspection andlooks for (see boundary sample):
y Correct Colory No Forming Flaws (I.E., Excess Carpet, Carpet
Wrinkles)
y Clean Trim Edge No Fuzz Or Debrisy Hole Clean No Slugsy Slots and additional cutouts are cut or punched
clean.y Overall Appearance Good
14.The quality inspector records the findings (If neededfollow SOP 8.3 Nonconforming product)
15.The quality inspector also checks for containerquantity and correct label
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The material handler:
y Brings carpet to the press and helps theoperator to load the carpet onto carpet feeder
y Provides shipping containers as requiredduring the shift
Process:
1. The operator uses pre-cut carpet and the operatorattaches the tenor frame to the carpet
2. The operator raises the carpet to the cutter and cutsthe carpet just above the tenor frame
3. The operator then places the tenor frame central overthe tool
4. The operator cycles the press by pressing the twoblack palm buttons simultaneously
5. When the press finishes its cycle, the operatorremoves the parts and the left over material
6. The operator then places the waste material into thecompactor
7. The operator inspects the part to verify 15 holes, oneslot, and 3 additional cutouts are clean with no slugs
or fabric strings or debris. If holes, slots, or cutouts
are not punched clean, followRework Instruction.
8. The operator burnishes the part edges of extra fuzz (ifnecessary).
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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 ISO9001/ 14001.
We have adopted the process approach advocated by
ISO 9000, by defining and managing:
y Process inputs, controls, and outputs to ensuredesired results are achieved, and
y Interfaces between interrelated processes toensure system effectiveness is achieved.
Specific responsibilities for and the sequence and
interaction of our key Quality/EnvironmentalSystems 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 Systemsdocuments.
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
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outsourced Quality/ Environmental Systems
processes (Section 7). Outsourced processes are also
depicted in our flowcharts; procedures governing
their management are described in documentsreferenced in applicable SOPs.
Documentation requirements
General
The Management, through the Management Team, is
responsible to implement and maintain a quality andenvironmental management system, and continually
improve its effectiveness.
Quality/Environmental Management System
processes, including their sequence and interaction
with other processes, have been identified and
documented in this Quality/ Environmental Manual,
and are 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.
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WORK INSTRUCTIONS
WI-DL-6.2.2
General Safety Notes
PPE:
y Safety Glassesy Kevlar Glovesy Kevlar Sleevesy Knife
General Notes
Setup includes:
yPress (See Setup Sheet)
y Check Fixturey Burnishing Tabley Final PackContainer
Material Needed:
y Carpet Milliken -62 rollStage Material for production:
The team leader ensures that the proper tenor frames
are available at the beginning of the shift and will
check throughout the shift.
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11.When the container is full, the operator calls thematerial handler to remove the container and bring an
empty one
12.The material handler puts a shipping label oncontainer and moves the container to the inspection
holding area
13.Part inspection14.Pack and labelRevision History
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Each Department Manager is responsible for
evaluating and adjusting resource requirements to
efficiently execute assignments and accomplish goals
defined in the business plan, including theimplementation and control of the 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
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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/EnvironmentalSystems processes.
Control of documents
Quality/Environmental records represent
information that demonstrates conformity to
Quality/Environmental Systems requirements and
effective operation ofThe Companys Quality andEnvironmental system. Pertinent records from our
subcontractors are an element of this.
Each Process Owner is responsible for identifying
which records they consider quality/environmental
records and for collection, storage, protection,
retrieval, and the retention and disposition of theserecords
Quality/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/TS requirements. Once retention time is met,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:
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Process:
1. The material is automatically loaded onto conveyorand into oven while the operator prepares the carpet
for insertion into the press
2. The operator uses the controls to roll out the carpetlong enough to place the tenor frames on the carpet
3. Attach both tenor frames to the carpet and cut thecarpet between them
4. Raise carpet to the cutter and cut the carpet justabove 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 twoblack palm buttons simultaneously
7. When the press finishes its cycle, the operatorremoves the parts and the left over material
8. The operator then places the part on over bendfixture 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 ashipping container
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WORK INSTRUCTIONS
WI-SB-5.2.2
Important General Safety Notes
PPE:
y Safety glassesy Gloves
Important General Notes
Setup includes:
y Pressy Carpet Cuttery Over Bend fixturey Check Fixturey Final PackContainer
Stage Material for production:
1. Material handler brings material to conveyor andsetup in proper position for conveyor load
2. Material handler brings carpet to the press to beloaded onto carpet cutter
3. Provide shipping container4. Two frames are required
Page: 13
a) Approve documents for adequacy prior to issue.b) Review, update as necessary, and re-approve
documents.
c) Identify the current revision status ofdocuments.
d) Ensure that relevant versions of applicabledocuments are available at points of use.
e) Ensure that documents remain legible, readilyidentifiable, and retrievable
f) Ensure that identified external documents(including customer-engineering
standards/specifications) have controlled
distribution
g) Prevent the unintended the use of obsoletedocuments, and to apply suitable identificationto them if they are retained for any purpose.
Engineering specifications
The Program Manager oversees our process for
assuring the timely review, distribution, and
implementation of all customer-engineeringstandards/ 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).
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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, wesubmit an updated PPAP.
(Section 7)
Master Lists
Requirements for the establishment and maintenance
of Master Lists of internal and external
Quality/Environmental Systems documents aredefined in SOP 4.2.3.
Control of records
Quality/Environmental records represent
information that demonstrates conformity to
Quality/Environmental Systems requirements and
effective operation ofThe Companys 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:a) Results of processes performed, including
identification of the individual performing the
activity.
b) Product/process evaluation/acceptance criteria
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Work Instructions
This booklet contains sample Work Instructions. Theyare very generic in nature and would need to be added toor changed for a real company.
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The corrective action is monitored for thirty days to
assure that the action taken has been successful.
Statistical methods (i.e. diagrams, x-bar and r charts,
etc.) are used when applicable. All corrective actionsare to be reviewed 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.
All forms used in the corrective and preventive
action procedure are retained for active life of the
product for reference to prevent reoccurrence.
Analysis of customer returned rejects will begin
upon receipt of the defective material. Records of
the analysis will be made available upon request. If acorrective action is initiated because of the analysis
will be tracked through the corrective action format.
Preventive Actions may be initiated because of,
TPM activities, lessons learned follow up, the
APQP process, Lean activities or technology
changes. Preventive actions will be tracked on the
Preventive Action Log.
Preventive actions will be reviewed during regular
management review meetings.
Revision History
Page: 15
c) Procedures, drawings, or instructions used toperform an activity, including revision or date of
document.
d) Identification of material, parts, or equipmentused in the making of the product
e) Personnel, material or equipment qualificationsf) Pertinent technical records from sub-contractors
Records Retention
SOP 4.2.4 contains related procedures and responsibilities
to ensure:
y Record controls established satisfy all regulatoryand customer requirements.
y Records controlled include customer-specifiedrecords.
y Disposition of records also includes theirdisposal.
y Management Responsibilityy Management commitment
The Managing Director, along with the management
team, is responsible to communicate the importance ofmeeting customer as well as statutory and regulatory
requirements. We provide evidence of commitment to
the development, implementation, and improvement of
our Quality/ Environmental Systems in very tangible
ways:
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Our quality policy statement (Section 5) documents and
communicates the importance of meeting or exceeding all
applicable requirements (including customer, regulatory
and legal requirements) through continual improvementof our processes, products, and services.
We ensure understanding, implementation, and
maintenance of our quality policy at all levels of the
organization through widespread printed distribution of
our quality policy statement, through periodic
management review of the quality policy statement, and
corporate level improvement objectives. We
communicate and deploy our quality policy and objectives
throughout the organization through individual
performance objectives established and reviewed during
employee performance reviews (Section 5 and 6).
y All managers demonstrate their commitment to thedevelopment and improvement of the Quality/
Environmental Systems through the provision of
necessary resources (Section 6), through their
involvement in the internal audit process, and
through their proactive involvement in our
continual improvement activities (Section 8).
Emphasis is placed on improving both effectiveness
and efficiency of our key Quality/Environmental
Systems processes.
Page: 121
SOP 8.3 Control of Nonconforming
Product Procedure
FOPARLOG Preventative Action Log
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.
All suspect parts are inspected and inventoried. The
quantity checked, the quantity defective, and
disposition of stock are determined and recorded.-
If future shipments are to be certified a method and
duration must be established by Manufacturing,
Quality, and the customer (if applicable).
The root cause of the problem is established anddocumented after the initial write up.
Corrective/Preventative action reports must be
complete through interim corrective action within
three days of issuance. Permanent corrective action
is to be determined by the team within 7 days of
issuance. The time frame to verify the effectivenessof the corrective action is to be determined by the
corrective action team. The team will utilize
mistake-proofing methodology to the degree
appropriate to the magnitude of the problems and
commensurate with the risks encountered.
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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
The Quality Manager is responsible for ensuring
that the corrective/preventative action is managed
effectively. 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.
5.0 Associated Materials
FOCAR8.5.2 Concern Report (MCR)
FOMCRLOG Material Concern Report Tracking
Log
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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
enhancingC
ustomer Satisfaction, throughC
ustomerfeedback and the following activities:
y The Company continually monitors and measurescustomer complaints and other customer input/
feedback to identify opportunities for improvement
(Section 8).
y These customer focused communications andinteractions 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).
y Our quality policy statement indicates ourcommitment 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
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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 aframework for establishing key corporate level
performance measures and related improvement
objectives. (Section 5)
y We ensure that our quality policy is communicatedand understood at all levels of the organization
through documented training, regular
communication, and reinforcement during annual
employee performance reviews (Section 6).
y Our quality policy statement is controlled byinclusion in this manual, and along with all policies
contained in this manual, is reviewed for continuing
suitability during management review meetings
(Section 5).
Quality/Environmental Policy
Management review meetings checks the Quality andEnvironmental policies and objectives for continuingsuitability.
Quality Objective
Our objective is to satisfy all of our customers with
quality products and services.
Page: 119
y Acceptable Product - some reworknecessary with written instructions &
records.
y Unacceptable Product (placed in redSCRAP container / on rack)
y Questionable Product (QA dispositionrequired)
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 material is re-inspected by the designatedQualityRepresentative. Conforming materials are
removed from the container and returned to
production flow. Nonconforming materials are
scrapped or reworked accordingly. Scrapped
material is recorded in the Scrap Log and the
Material Concern Report.
All material shipped under a customer concession
or deviation will be identified as required by the
customer. Records of the quantity and expiration
date shall be maintained.
Revision History
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SOP 8.5.2 Corrective/Preventive Action
Procedure
FO 8.3 Quarantine Area Record
FO 8.3 Scrap Log
6.0 Procedure
When material is found to be nonconforming, the
container(s) is identified by a Quality representative
or production supervisor with an initial Material
Concern Report. (If material is part of an
accumulation, a Material Concern Report will beissued at the time of occurrence)
The non-conforming material is moved 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 employeeconducting these activities. There are four possible
determinations of inspected product:
y Acceptable Product green check mark
Page: 19
Quality Policy
Our Objective Will Be Accomplished Through Customer
Satisfaction by Providing:
1. Make statement2. 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 Companys 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.
The quality manual documents the necessary processesthat define the planning process for
quality/environmental management system and
objectives.
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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):
y Customer Satisfaction: Managing Director(Section 8)
y Supplier Performance: Materials Manage(Section 7)
y Quality/Environmental Systems Effectiveness: ISOManagement Representative. (Section 8)
y Overall Operational Efficiency and ManufacturingProcess Efficiency (Section 5 and 6)
y Training Effectiveness and Employee Awareness:Human Resource Director (HRD) with input from
the Training Manager. (Section 6)
y Product Performance: Program Manager. (Section7)
y Effectiveness of Manufacturing Processes:Production Manager (Section 7)
y Product Quality: Quality Manager (Section 8)Page: 117
product which does not conform to specified
requirements. It is clearly (visually) identified and
quarantined or segregated to prevent inadvertent
use or installation. Material is reviewed anddisposition 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.
4.3 The Quality Manager is responsible for
notifying the customer if non-conforming
material is detected after shipment has been made
or use has started. Actions will be taken such as
stock returns and replacement, sorting or even
sending a company representative to their site toprotect their interests.
5.0 Associated Materials
FO 8.3 NCMRMaterial Concern Report
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Page: 116
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.)
Suspect Product: All material having the same lot
number as known nonconforming product.
4.0 Responsibility
The Production Supervision and Quality
Department are responsible for following
documented procedures and work instructions for
Page: 21
Quality objectives Supplemental: Top management
utilizes the management review process (Section 5) to
define quality objectives and measurements to include in
ourB
usiness 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 to achieve as a Full Service
Supplier (FSS) to the automotive industry:
a) Achievement of Zero Defects and 100% on timedelivery performance. (Section 7 and 8)
b) Manage and control facilities, processes, qualitysystems and personnel to consistently and cost
effectively produce products and furnish services
that meet customer needs (Section 7).
c) Develop and implement Advanced Product QualityPlanning (APQP) practices and procedures inaccordance 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 suppliedproducts 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
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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 improvementby emphasising reduction of part-to-part variationand the elimination of all waste. (Section 8)
g) Conduct operations in conformance with, or toexceed, all applicable environmental laws and
regulations of the jurisdictions in which we do
business (Section 6).
h) Meet customer requirements by controlling andusing returnable packaging, of. (Section 7).
Quality management system planning
The Quality/Environmental Systems planning process
involves the establishment and communication of our
quality policy and objectives through issuance of thismanual and its associated procedures, and through the
provision of resources needed for its effective
implementation. This manual constitutes our overall plan
for establishing, maintaining, and improving systems.
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Determine Effectiveness of Training
One or more of the following determines training
effectiveness:
y Review of Salaried and Hourly Evaluationsy Post-training tests, when applicabley Employee on the job performance
Revision History
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Page: 114
5.0 Associated Materials
Orientation Manual
Job Descriptions
6.0 Procedure
Identify training needs.
The Company employees and their
manager/supervisor shall review the employees
training status to determine training needs. Thisreview occurs concurrently with the employees
performance evaluation or upon need.
Provide Training
One or more of the following provides formal
training:
y Identified The Company Trainersy Professional / Industry Organizations or
Societies
y Local Community and Trade Schoolsy College and University Sponsored Classesy On-The-Job training is provided for all
personnel, including contract or service
personnel, in any new or modified job.
Page: 23
Our management review process and internal audit
process ensure the integrity of our System is maintained
when significant changes are planned and implemented
that affect our key Systems. (Sections 5, 6, and 8)
The Quality Manager develops appropriate quality
planning documents for specific products, projects, or
contracts whenever customer requirements exceed the
capability or intent of the product/service realization and
support processes described in our
Quality/Environmental Systems (Section 7).
Responsibility, authority, and communication
Responsibility and authority
The Managing Director (MD), with the help of
department managers, sets direction and ensures the
success of our business through the clear definition and
communication of Quality/Environmental Systems
responsibilities and authorities. Other members of Top
Management include:
y The Operations Managing andy The Human Resource Director
The interrelationship of Top Management and other key
personnel is depicted our Organization Chart.
Responsibility for quality
Overall Quality/Environmental Systems responsibility
and authority is as follows:
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Top Management
Members of Top Management are ultimately responsible
for the quality ofThe Companys 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 controllingQuality/ 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 actionpromptly 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).
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employees 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 training courses offered internally are
continually assessed by the Human Resource
Department. The content of the courses are
evaluated through a training feedback and
evaluation form, and an assessment test (if
applicable) is given upon completion of thecourse.
It is the responsibility of the Manufacturing
Supervisor to inform personnel whose work
affect quality of the consequences to the customer
of nonconformity to quality requirements.
It is the responsibility of the TS-16949 ManagementRepresentative to measure the extent to which our
personnel are aware of the relevance and
importance of their activities and how they
contribute to the achievement of the quality
objectives.
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Training Records
Hourly Employees: Records of hourly training
needs and training received by active employees
performing activities affecting quality shall bemaintained by the Human Resource Department.
Each hourly employee has an individual training
record, which is maintained by the Human
Resource Department. These records include, but
are not limited to, training matrices and copies of
training certificates.
Salary Employees: Records of salary training needs
and training received by active employees
performing activities affecting quality shall be
maintained by the Human Resource Department.
Each salary employee has an individual training
record, which is maintained by the Human
Resource Department. These records include, butare 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. Personnelwhose work affects quality are informed 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
Page: 25
Employees
All employees are responsible for the quality of their
work and implementation of the policy and procedures
applicable to processes they perform. Personnelresponsible for product quality have the authority to stop
production to correct quality problems (Section 8).
Detailed responsibilities and authorities for Quality/
Environmental Systems implementation and
improvement are contained in lower level documents
referenced throughout this manual and otherQuality/Environmental Systems documents including
procedures, flow charts, job descriptions, work
instructions, etc.
Management representative
The Company has appointed Quality and Environmental
Management representatives for each system. The
management representatives have the responsibility and
authority to:
y Ensuring that the ISO/TS 16949:2002 processesneeded for quality and environmental management
systems are established, implemented, and
maintained in accordance with their respectivestandards
(Section 5).
y Ensuring the promotion of awareness of customerand environmental requirements throughout the
organization (Section 5)
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y The Environmental Management Representative isresponsible 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:
y The ISO Management Representative postsinformation on quality bulletin boards throughout
the facility to convey information regarding
customer requirements, and the status and
importance of quality activities.
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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.
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Page: 110
9.0 Associated RecordsManagement ReviewReport: 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.
Documented using form FO-MRR-5.6.1,
Management ReviewReport.
Quality Objectives Matrix: Record of established
quality objectives. Documented on the title page ofthe Management ReviewReport (MRR5.6).
Revision History
Page: 27
y The Company uses internal audits (Section 8) toreinforce or communicate appropriate information
to employees.
The Operations Manager posts information on safety
bulletin boards throughout the facility to convey
information 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 throughproduction 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
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or designee chairs the corporate reviews and top
management from all relevant functions attends. (Section
8)
The Company record review results provide at aminimum, 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 onquality, safety, and environment. The primary output of
management 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 toreview plant specific data and process effectiveness
indicators, identifying opportunities for improvement and
corrective and preventative actions.
Quality system performance
Each management review includes all requirements of the
Quality/Environmental Systems including monitoring ofquality objectives (Section 5), regular evaluation of the
cost of poor quality (Section 8) , and an assessment of the
suitability and effective of support processes (i.e. plant,
facility and equipment, Section 6) as an essential part of
our continual improvement process (Section 8).
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Resource needs for implementing improvement
actions are identified. These include assignment of
responsibility, time frame, and allocation of human,
equipment, technical knowledge, and other
necessary resources.
7.0 RecordsManagement review records must be as
comprehensive as possible. They will be the sole
evidence that the agenda of the review was
completely covered, and that the review wasconcluded with appropriate decisions and actions.
Management review output is documented in the
Management ReviewReport 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. The location and retention
period for management review records are specified
in Operational Procedure SOP 4.2.4, Control of
Records.
8.0 Referenced Documents5.6.1 Management ReviewReport Form
SOP 4.2.4 Operational Procedure, Control ofRecords
SOP 8.5.2 Operational Procedure, Corrective and
Preventive Action
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Page: 108
6.0 Management review outputy Improvement of the quality management system,y Improvement of quality performance, andy Improvement of products and/or services to
better meet customer requirements and increase
customer satisfaction
These improvement actions are defined implemented as:
Management review actions
Documented in the Management ReviewReport(FO-MRR-5.6.1) in theActions, Assigned to, and Due
Datecolumns. This type of action is most suitable
for minor improvements that can be quickly
implemented, and which are not directly related to
product or process conformity.
Corrective or preventive actions
Documented in the Corrective Action Request
(CAR) form (FO-NCCAR-8.2.3) and processed in
accordance with procedure SOP 8.5.2, Corrective
and Preventive Actions. CARs are normally used
for improvements related to specific actual or
potential product or process nonconformities.
Quality objectives
Documented on the title page of the Management
ReviewReport (refer to Section 6 of this
procedure). This method is most suitable for
implementing long-term improvement goals.
Page: 29
At a minimum, we use these results to demonstrate
achievement of the quality objectives in our Business Plan
and customer satisfaction with supplied product.
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 affectthe 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.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
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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.
5. Resource ManagementProvision 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
provided through our budgeting and other business
management processes including:
Page: 107
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 theprevious 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 itstarget value, or extend the target due date.
Objectives that have been achieved may be
discontinued or be retained with a higher target
value.
Any quality objectives that are carried on into the
next period and any new objectives established bythe review meeting are documented in the Quality
Objectives Matrix on the title page of the
Management ReviewReport.
The principal quality policy is reviewed 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.
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Changes and quality system planning
Quality highlights any product, process, capacity, or
other operational or organizational changes that
affect the quality system and proposes specificactions 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.
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 policyAn 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
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Subject
y Quality/Environmental Planningy Business Planningy Human Resource Planningy Plant, Facility, Equipment and other
Infrastructure Planning
y Contingency Planningy Work Environment, and Safety Planningy Product Quality Planning (including Advance
Product Quality Planning)
y Planning ofCustomer-related Processesy Product and Manufacturing Process Design
and Development Planning
y Planning of Purchased Product (Materials,Services and Vendors)
y Production, and Service Provision Planningy Measurement Systems Planning (including the
conduct of MSA)
y Measurement, Analysis, and ImprovementPlanning (including the use of SPC)
y Organizational Continual ImprovementPlanning
y Manufacturing Process Continualy 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
TheC
ompany ensures that all employees who performactivities 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 ofmanagement 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.
Competence,Awareness, and Training
The Company maintains a Training/Competence Matrix
for personnel by job description. It is a four-quadrant
system. It is which visually displays the capabilities of the
person according to which of the quadrants have been
achieved. This Competency Matrix is available to persons
assigning work. All personnel understand the importance
of their activities and their contribution to the
achievement of the quality and environmental objectives.
(SOP 6)
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abandoned. Reasons for the failure to implement
the action and any decisions regarding continuation
of the action are recorded in the Management
ReviewReport.
Process performance and product conformity
Quality presents quality performance data. This
includes rates of process and product
nonconformities, on-time delivery performance,
supplier quality performance, and productivity data.
Edit the scope of the quality performance data asappropriate, 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.
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Page: 104
Manager may call for unscheduled extraordinary
reviews.
Attendance
Management reviews are chaired by the Quality
Manager and are 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 thanone manager may be absent from the meeting. The
Operations Manager and Quality Manager must
always attend.
Agenda
The agenda for management review meetingscovers at least all items listed in Section 4 of this
procedure. The agenda is documented on the cover
page of the Management ReviewReport.
Management review input
At a minimum, the following information and data
are presented for review:
Follow-up actions from previous reviews
Quality reports on the status of action items from
the previous meetings. Actions which are not
completed may be extended with a new due date,
reassigned to another person/function, changed, or
Page: 33
Need Determination
Department managers and supervisors are responsible to
identify required training and competency for personnel
in their respective areas and to coordinate training andfollow through with evaluations for competencies. Our
TrainingCoordinator 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 applicantsfor 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). At a minimum, these
include:
Product design skills
The Program Manager ensures that personnel with
product or manufacturing process design responsibility
(Section 7) are competent to achieve design requirements
and are skilled in design methods (Section 7) needed to
achieve desired results.
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
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Page: 34
required, with particular attention to the satisfaction of
customer requirements (application of digitized
mathematically based data, e.g.).
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 ourobjectives.
Employee motivation and empowerment
The management team is responsible to motivate
employees to achieve quality objectives, to make
continual improvements and to create an environment to
promote innovation.
The Company carries out periodic audits with
employees to determine their awareness of the relevance
and importance of their activities and contribute to the
achievement of the quality and environmental objectives.
We conduct Annual employee reviews to give one on one
interaction of communication employee withThe
Company Management.
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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 ApplicationThis procedure applies to all activities comprising
the quality system, and in particular those named in
Section 4, Review Input, of this procedure.
3.0 DefinitionsNone
4.0 ProcedureFrequency and Scheduling
Quality performance and the quality management
system are reviewed at least once a year. The annual
review is conducted in March.
For the first two years (i.e., through the maturation
phase of the quality system), management reviews
are conducted twice a year. The additional review is
conducted in September. In response to changing
or special conditions and events, the Operations
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Page: 102
6.0 ProcedureThe responsible personnel and/or departments
ensures the validity and completeness, and
determines the filing and storage method (forretrievability and preventing damage) and the
retention duration (conforming to TS-16949
requirements) for quality records. The retention
duration listed is a minimum retention. The
records may be retained longer for reference at
the discretion of the responsible party. The status
of archived records is determined and appropriaterecords are disposed of annually.
The Quality Department retains superseded part
documents used for new part qualification.
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, shall be maintained for the length of
time established by the corresponding
Department Manager and in accordance with
minimum customer requirements.
Revision History
Page: 35
Provision.
We utilize the employee performance review process to
motivate employees to achieve individual or functional
performance objectives that support achievement of ourcorporate 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 ouremployee 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
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achieving our quality policy (Section 5) and objectives
(Section 5). This is accomplished through awareness
training, employee performance reviews (Section 6), and
employee participation 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. Employee qualification/competency review
records and annual performance review results aremaintained by the Human Resources Department. 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 detailmethods 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
Page: 101
Accounting department and the Materials Manager
are responsible for ensuring the proper retention of
subcontractor purchase orders and amendments.
The Materials Manager and Accounting departmentare responsible for ensuring the proper retention of
customer related purchase orders and amendments.
5.0 Associated Materials AIAG APQP Advanced Product Quality
Planning Manual
AIAG FMEA Failure Mode Effect Analysis
Manual
AIAG MSA Measurement Systems Analysis
Manual
AIAG SPC Statistical Process Control
Manual
AIAG PPAP Production Part Approval
Process
SOP 5.6 Management Review Procedure
SOP 7.2 Contract Review Procedure
SOP 8.2.2 Internal Audit Procedure
FO 4.2.4 DD Destroyed Documents List
FO 4.2.4 QR QualityRecords List
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Page: 100
CONTROL OF RECORDS
SOP 4.2.4
1.0 PurposeThis procedure provides a method of maintaining
quality records consisting of identification,
collection, indexing, filing, storage, and disposal.
2.0 ApplicationThis procedure applies to all departments
responsible for the maintenance of quality records.
3.0 DefinitionsNone
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 systemaudits, and management review.
The Program Manager and/or designee is
responsible for ensuring the proper retention of
appropriate tooling records. This is inclusive of all
prints.
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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 Maintenanceprograms in accordance with SOP 6.3; these programs
include:
y Facilities management, maintenance and repairy Housekeeping/custodial services managementy Process equipment management, maintenance and
repair
y Production tooling management, andy Transportation and material handling equipment
management, maintenance, and repair
Plant, facility, and equipment planning
The MD uses a multidisciplinary approach for developing
plant, facility, and equipment plans. The Program
Manager ensures plant layouts are designed and
continually evaluated through the application of lean
manufacturing principles (state your approach here) to
minimize material travel, handling and value-added use offloor space and facilitate synchronous material flow.
The Plant Supervisor develops and implements an
effective preventive maintenance program utilizing
predictive maintenance methods (Section 7) as
appropriate. The Information Systems Manager has
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overall responsibility for managing our automated data
processing and communications systems. Management
reviews the effectiveness of these efforts during
management review meetings (Section 5).
Contingency plans. The Quality Manager, in conjunction
with the Information Systems Manager and other
appropriate managers, ensures contingency plans are
documented in the Business Plan and implemented as
needed to satisfy customer requirements in the event of
an emergency such as utility interruptions, labor
shortages, and key equipment failure and field returns.
Work environment
We provide employee benefits, job and schedule
flexibility, interesting work, and involvement of our
employees in an 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 andenvironmental 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,
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Department Managers are responsible for
reviewing all of their applicable documents within
their departments at a minimum of annually to
insure relevance and conformance.
5.0 Associated Materials
SOP 4.2.4 Control of QualityRecords Procedure
SOP 7.3 Advanced Quality Planning Procedure
WI 4.2.3 Documentation Writing Procedures
and Work Instructions
Revision History
C l P d d E i i Ch d h h f i d i i (S i
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Control Procedure and EngineeringChange
Process.
The Program Manager is responsible for receiving,
reviewing and retainingCAD/ 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
obsolete copies are retrieved and replaced with the
latest revision. Both the person receiving a copy of
a new or revised document and the persondistributing the document are responsible for
ensuring that obsolete copies are identified and/or
disposed of.
The Plant Supervisor is responsible for ensuring
records of Total Preventive Maintenance activities
are maintained.
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) are in agreement.
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and through safety team meetings and training (Section
6).
Personnel safety to achieve product quality: We design
and carry out production processes to ensure productsafety 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)
6. Product RealizationPlanning of product realization
1. The Company has implemented a Quality andEnvironmental-planning process to define and
document 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/
TS16949 standard and sets the framework for all
Company processes of the quality/environmental
management systems.
2. For new projects, a cross functional team plans theprocesses with consideration given to, but not limited
to, the following:
Th lit / i t l bj ti d 4 0 R ibilit
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a. The quality/environmental objectives andrequirements for the product
b. Environmental aspects/impactsc. 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 testequipment), 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 thatthe realization processes and resulting product
meet company and customer requirements per the
quality and environmental plans
h. Customer requirements and references totechnical specifications are to be included in thequality plan
3. The Company uses the methods in the APQP, SPCPFMEA, PPAP, MSA, and Control Plan manuals as
required.
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4.0 Responsibility
The Department Managers are responsible for
ensuring that the Quality System Procedures have
the appropriate controls in place to ensure thatcurrent issues are available in all locations as
required.
The Quality Manager and/or designee is
responsible for retaining master copies and assuring
current revision level of the AIAG reference
manuals:
y Advanced Product Quality Planning &Control Plan
y Fundamental Statistical Process Controly Measurement Systems Analysisy Potential Failure Mode and Effects Analysisy Product Part Approval Processy Quality System Requirements TS 16949y 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
4 The quality plan and relevant work instructions
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CONTROL OF DOCUMENTS
SOP 4.2.3
1. Purpose
This procedure describes the responsibilities for
receipt, review, and distribution of drawings and
documents, including documents of external origin.
2. Application
This procedure applies to statutory & regulatory
requirements the drawings specifications and
documents that explain the engineering
requirements, manufacturing processes, assembly
methods, test procedures, work instructions and
inspection instructions related to deliverable goods
and our processes.
3. Definitions
y Quality Manager is the Document ControlSpecialist
y Controlled Customer owned product relatedprints & specifications are located on the X
drive and are available to Engineering Quality
&Manufacturing personnel
y AIAG Automotive Industry Action Group
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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 productsand projects under development, and related product
information, including electronic data.
6. The Company assesses product and manufacturingprocess changes that affect product realization. We
confirm defined activities to ensure compliance with
customer requirements. When we receive theapproval for any changes affecting customer
requirements, we notify the customer and validate
changes before implementation.
Planning of product realization Supplemental
We review proprietary designs, impact use with the
customer.. (Section 7)
Our APQP/PPAP process, as detailed in SOP 7.1
provides a consistent advanced product quality planning
process acceptable to all of our customers. The APQP
Team uses the APQP process:
y Develop a control plany Develop/review failure modes and effects analysisy Setup actions to reduce potential failure modes with
high risk
y Report required deliverables (i.e. Tooling, Fixtures,PFMEA, Control Plans, PPAP, Run @ Rate, etc.)
Special Characteristics for inclusion in the control plan 6 0 Procedure
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Special Characteristics for inclusion in the control plan
comply with customer specifications (including drawings,
FMEAs, operator instructions, etc.) that affect product
characteristics and process parameters.
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. PPAP approval is obtained
prior to the first production shipment of product (unless
specifically waived by the customer).
The APQP Team Leader ensures:
y Submissions for part approval prior to theimplementation of changes, to determine the type
of quality re-certification required (PPAP
documentation.)
y Production following any change in process ormethod of manufacture
y Change of source for subcontracted parts, materials,or services (e.g. heat treating or plating)
y Product re-released after the tooling has beeninactive 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).
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6.0 ProcedureAny member of staff, through their department
manager, may request document changes. If a
Quality System procedure needs to be changed,send a Quality Manual Change Request Form to the
Quality Manager describing the proposed change.
The changes become part of the revision history. If
not approved, the request form gives an explanation
and a copy returned to the originator. The Quality
Department files original form.
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 unacceptablecosts which would be incurred by disposing of
unused forms.
Revision History
The Program Manager and/or designee are Confidentiality
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The Program Manager and/or designee are
responsible for controlling issuance and
maintenance of drawings.
Department/Plant Supervisor are responsible forcontrolling 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 relatingto 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 A