XYZ COMPANY

IATF 16949 QUALITY MANUAL

Order Quality Manual

DATE:
REVISION 01

UNCONTROLLED COPY

CONTROLLED COPY

Serial # _________

Issued To: ___________________________ Date: ___________

SAMPLE
Note: This sample manual only contains partial text therefore, the numbering is not
consecutive.
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Table of Contents

Introduction.................................................................................................................................................................... 8

1.0 SCOPE.....................................................................................................................................9
1.1 Products and services...................................................................................................................................... 9

1.2 Applicability....................................................................................................................................................... 9

1.3 Quality policy statement................................................................................................................................. 10

2.0 COMPANY HISTORY AND CONTACT INFORMATION.......................................................11

3.0 TERMS AND DEFINITIONS..................................................................................................11

4.0 CONTEXT OF THE ORGANIZATION...................................................................................12

4.1 Understanding the organization and its context..........................................................................................12

4.2 Understanding the needs and expectations of interested parties..............................................................12

4.3 Determining the scope of the quality management system........................................................................13

4.3.1 Determining the scope of the quality management system - supplemental..................................................13
4.3.2 Customer-specific requirements.................................................................................................................... 13

4.4 Quality management system and its processes........................................................................................... 13

4.4.1.1 Conformance of products and processes.................................................................................................17
4.4.1.2 Product safety........................................................................................................................................... 17

5.0 LEADERSHIP........................................................................................................................17
5.1 Leadership and commitment.......................................................................................................................... 17
5.1.1 General......................................................................................................................................................... 17
5.1.1.1 Corporate responsibility............................................................................................................................ 18
5.1.1.2 Process effectiveness and efficiency........................................................................................................ 18
5.1.1.3 Process owners........................................................................................................................................ 19
5.1.2 Customer focus............................................................................................................................................. 19

5.2 Policy................................................................................................................................................................ 19
5.2.1 Establishing the quality policy....................................................................................................................... 19
5.2.2 Communicating the quality policy.................................................................................................................. 20
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5.3 Organizational roles, responsibilities and authorities.................................................................................20

5.3.1 Organizational roles, responsibilities, and authorities supplemental..........................................................22
5.3.2 Responsibility and authority for product requirements and corrective actions...............................................22

5.4 Management responsibilities......................................................................................................................... 22

5.5 Management representative........................................................................................................................... 23

6.0 PLANNING.............................................................................................................................24
6.1 Actions to address risk and opportunities.................................................................................................... 24
6.1.1........................................................................................................................................................................... 24
6.1.2........................................................................................................................................................................... 24
6.1.2.1 Risk analysis............................................................................................................................................. 25
6.1.2.2 Preventive action...................................................................................................................................... 25
6.1.2.3 Contingency plans.................................................................................................................................... 25

6.2 Quality objectives and planning to achieve them........................................................................................27

6.2.1 General......................................................................................................................................................... 27
6.2.2 Planning to achieve quality objectives........................................................................................................... 27
6.2.2.1 Quality objectives and planning to achieve them - supplemental..............................................................27
6.2.3 Classification of quality objectives................................................................................................................. 28
6.2.4 Key initiatives................................................................................................................................................ 28

6.3 Planning of changes....................................................................................................................................... 28

7.0 SUPPORT..............................................................................................................................29
7.1 Resources........................................................................................................................................................ 29
7.1.1 General......................................................................................................................................................... 29
7.1.1.1 Responsibilities for determination of required resources......................................................................30
7.1.1.2 Provision of resources.......................................................................................................................... 30
7.1.2 People........................................................................................................................................................... 30
7.1.3 Infrastructure................................................................................................................................................. 30
7.1.3.1 Plant, facility, and equipment planning...................................................................................................... 30
7.1.4 Environment for the operation of processes.................................................................................................. 31
7.1.4.1 Environment for the operation of processes supplemental....................................................................31
7.1.4.2 Personnel safety to achieve product quality.............................................................................................. 32
7.1.5 Monitoring and measuring resources............................................................................................................ 32
7.1.5.1 General..................................................................................................................................................... 32
7.1.5.2 Measurement traceability.......................................................................................................................... 33
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7.1.5.3 Laboratory requirements........................................................................................................................... 34

7.1.6 Organizational knowledge............................................................................................................................. 35

7.2 Competence..................................................................................................................................................... 35
7.2.1 General......................................................................................................................................................... 35
7.2.2 Competence, awareness and training........................................................................................................... 36
7.2.2.1 Competence on-the-job training............................................................................................................. 36
7.2.3 Internal auditor competency.......................................................................................................................... 36
7.2.4 Second-party auditor competency................................................................................................................. 37

7.3 Awareness....................................................................................................................................................... 37
7.3.1 Awareness supplemental........................................................................................................................... 38
7.3.2 Employee motivation and empowerment...................................................................................................... 38

7.4 Communication............................................................................................................................................... 38
7.4.1 General......................................................................................................................................................... 38
7.4.2 Internal communication................................................................................................................................. 39
7.4.3 External communication................................................................................................................................ 39

7.5 Documented information................................................................................................................................ 39

7.5.1 General......................................................................................................................................................... 39
7.5.1.1 Quality management system documentation............................................................................................40
7.5.1.2 Quality system manual......................................................................................................................... 40
7.5.2 Creating and updating................................................................................................................................... 40
7.5.3 Control of documented information............................................................................................................... 40
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8.0 OPERATION..........................................................................................................................41
8.1 Operational planning and control.................................................................................................................. 42
8.1.1 Planning of product and service realization................................................................................................... 42
8.1.2 Operational planning and control supplemental........................................................................................ 43
8.1.3 Confidentiality................................................................................................................................................ 43
8.1.4 Acceptance criteria........................................................................................................................................ 43

8.2 Requirements for products and services...................................................................................................... 43

8.2.1 Customer communication............................................................................................................................. 43
8.2.1.1 Customer communication supplemental.............................................................................................. 44
8.2.2 Determining the requirements related to products and services...................................................................44
8.2.2.1 Determining the requirements for products and services supplemental.................................................44
8.2.3 Review of requirements related to products and services.............................................................................45
8.2.3.1 Review of requirements related to products and services supplemental..............................................45
8.2.3.2 Customer- designated special characteristics...........................................................................................45
8.2.3.3 Organization manufacturing feasibility...................................................................................................... 45
8.2.4 Changes to requirements for products and services.....................................................................................46

8.3 Design and development of products and services.....................................................................................46

8.3.1 General......................................................................................................................................................... 46
8.3.1.1 Design and development of products and services supplemental.........................................................47
8.3.2 Design and development planning................................................................................................................ 47
8.3.2.1 Design and development planning supplemental..................................................................................47
8.3.2.2 Product design skills................................................................................................................................. 48
8.3.2.3 Development of products with embedded software..................................................................................49
8.3.3 Design and development inputs.................................................................................................................... 49
8.3.3.1 Product design input................................................................................................................................. 49
8.3.3.2 Manufacturing process design input......................................................................................................... 50
8.3.3.3 Special characteristics.............................................................................................................................. 51
8.3.4 Design and development controls................................................................................................................. 51
8.3.4.1 General................................................................................................................................................. 51
8.3.4.2 Design and development review........................................................................................................... 51
8.3.4.3 Design and development validation...................................................................................................... 52
8.3.4.4 Prototype programme............................................................................................................................... 53
8.3.4.5 Product approval process......................................................................................................................... 53
8.3.5 Design and development outputs.................................................................................................................. 53
8.3.5.1 Design and development outputs supplemental....................................................................................53
8.3.5.2 Manufacturing process design output....................................................................................................... 54
8.3.6 Design and development changes................................................................................................................ 55
8.3.6.1 Design and development changes supplemental..................................................................................55

8.4 Control of externally provided processes, products and services.............................................................55

8.4.1 General......................................................................................................................................................... 56
8.4.1.1 General - supplemental (under control of externally provided processes, products and services)...........56
8.4.1.2 Supplier selection process........................................................................................................................ 56
8.4.1.3 Customer-Directed Sources (also known as DirectedBuy)...................................................................57
8.4.2 Type and extent of control............................................................................................................................. 57
8.4.2.1 Type and extent of control supplemental............................................................................................... 58
8.4.2.2 Statutory and regulatory requirements...................................................................................................... 58
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8.4.2.3 Supplier quality management system development..................................................................................58

8.4.2.4 Supplier monitoring................................................................................................................................... 59
8.4.2.5 Verification of purchased product......................................................................................................... 61
8.4.3 Information for external providers.................................................................................................................. 61
8.4.3.1 Purchasing information......................................................................................................................... 61
8.4.3.2 Information for external providers supplemental....................................................................................62

8.5 Production and service provision.................................................................................................................. 62

8.5.1 Control of production and service provision.................................................................................................. 62
8.5.1.1 Control plan.............................................................................................................................................. 63
8.5.1.2 Standardized work operator instructions and visual standards..............................................................64
8.5.1.3 Verification of job set-ups.......................................................................................................................... 64
8.5.1.4 Verification after shutdown........................................................................................................................ 64
8.5.1.5 Total productive maintenance................................................................................................................... 64
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment...............65
8.5.1.7 Production scheduling............................................................................................................................... 66
8.5.1.8 Validation of processes for production and service provision...............................................................66
8.5.2 Identification and traceability......................................................................................................................... 67
8.5.2.1 Identification and traceability supplemental..........................................................................................67
8.5.3 Property belonging to customers or external providers.................................................................................68
8.5.4 Preservation.................................................................................................................................................. 68
8.5.4.1 Preservation supplemental.................................................................................................................... 68
8.5.5 Post-delivery activities................................................................................................................................... 69
8.5.5.1 Feedback of information from service....................................................................................................... 69
8.5.5.2 Service agreement with customer............................................................................................................. 69
8.5.6 Control of changes........................................................................................................................................ 70
8.5.6.1 Control of changes supplemental.......................................................................................................... 70

8.6 Release of products and services................................................................................................................. 71

8.6.1 Release of products and services supplemental......................................................................................71
8.6.2 Layout inspection and functional testing....................................................................................................... 72
8.6.3 Appearance items......................................................................................................................................... 72
8.6.4 Verification and acceptance of conformity of externally provided products and services..............................72
8.6.5 Statutory and regulatory conformity.............................................................................................................. 73
8.6.6 Acceptance criteria........................................................................................................................................ 73

8.7 Control of nonconforming outputs................................................................................................................ 73

8.7.1.1 Customer authorization for concession..................................................................................................... 74
8.7.1.2 Control of nonconforming product customer specified process.............................................................74
8.7.1.3 Control of suspect product........................................................................................................................ 74
8.7.1.4 Control of reworked product...................................................................................................................... 74
8.7.1.5 Control of repaired product....................................................................................................................... 75
8.7.1.6 Customer notification................................................................................................................................ 75
8.7.1.7 Nonconforming product disposition........................................................................................................... 75

9.0 PERFORMANCE EVALUATION...........................................................................................75

9.1 Monitoring, measurement, analysis, and evaluation....................................................................................76
9.1.1 General......................................................................................................................................................... 76
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9.1.1.1 Monitoring and measurement of manufacturing processes..................................................................76

9.1.1.2 Identification of statistical tools................................................................................................................. 77
9.1.1.3 Application of statistical concepts............................................................................................................. 77
9.1.2 Customer satisfaction.................................................................................................................................... 77
9.1.2.1 Customer satisfaction supplemental...................................................................................................... 78
9.1.3 Analysis and evaluation................................................................................................................................ 78
9.1.3.1 Prioritization.............................................................................................................................................. 79

9.2 Internal audit.................................................................................................................................................... 79

9.2.1.1 Internal audit program............................................................................................................................... 80
9.2.1.2 Quality management system audit............................................................................................................ 80
9.2.1.3 Manufacturing process audit..................................................................................................................... 81
9.2.1.4 Product audit............................................................................................................................................. 81

9.3 Management review........................................................................................................................................ 81

9.3.1 General......................................................................................................................................................... 81
9.3.1.1 Management review supplemental........................................................................................................ 81
9.3.2 Management review inputs........................................................................................................................... 81
9.3.2.1 Management review inputs supplemental..............................................................................................82
9.3.3 Management review outputs......................................................................................................................... 82
9.3.3.1 Management review outputs supplemental............................................................................................83

10.0 IMPROVEMENT.....................................................................................................................83
10.1 General............................................................................................................................................................. 83

10.2 Nonconformity and corrective action............................................................................................................ 83

10.2.1......................................................................................................................................................................... 84
10.2.2......................................................................................................................................................................... 84
10.2.3 Problem solving........................................................................................................................................ 84
10.2.4 Error-proofing............................................................................................................................................ 85
10.2.5 Warranty management systems............................................................................................................... 85
10.2.6 Customer complaints and field failure test analysis..................................................................................86

10.3 Continual improvement.................................................................................................................................. 86

10.3.1 Continual improvement supplemental.................................................................................................... 86

Inspection and Test Procedure................................................................................................................................... 88

Corrective and Preventive Action Procedure.................................................................................................................. 92

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Introduction

XYZ Company recognizes its responsibility as a manufacturer of quality products/provider of quality

services. To this end, XYZ Company has developed and documented a quality management
system. The quality management system complies with the international standard IATF 16949:2016,
Automotive Quality Management System Standard. The quality management system is commonly
referred to as the quality system or QMS.

This Quality Manual applies to sites of the organization where customer-specified parts, for
production and/or service, are manufactured, supporting functions, whether on-site or remote and
throughout the entire automotive supply chain.

The purpose of this manual is to provide comprehensive evidence to all customers, suppliers and
employees of what specific controls are implemented to ensure product/service quality. This manual
also governs the creation of quality related documented information. It will be revised, as necessary,
to reflect the quality system currently in use. It is issued on a controlled copy basis to all internal
functions affected by the quality management system and on an uncontrolled copy basis to
customers and suppliers. It may be issued to customers on a controlled copy basis upon customer
request.

This manual is divided into ten main sections. Sections 4-10 are modeled on the sectional
organization of the IATF 16949:2016 standard. Sections are further subdivided into several
subsections representing main quality system elements or activities.

__________________________________
(Name), President
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4.4.1.1 Conformance of products and processes

XYZ Company ensures that all products and processes conform to all applicable customer,
regulatory, statutory requirements, and expectations of all interested parties. This includes
outsourced processes and parts for services. For details, refer to the Risk Management Procedure,
Process Control Procedure, Inspection and Test Procedure, Purchasing Procedure, Servicing
Procedure, Internal Audits Procedure, and Management Review Procedure.

4.4.1.2 Product safety

XYZ Companys has developed and implemented a Product Safety Management Procedure to
manage product safety. Design, manufacturing, and servicing processes further support product
safety initiatives.

5.1.1.1 Corporate responsibility

XYZ Company promotes an ethical business culture and focuses on maintaining integrity in all of its
business activities. To this end, XYZ Company has developed and enforces documented corporate
responsibility policies. For details, refer to the Anti-Bribery Policy and Employee Code of Conduct,
which also includes an escalation policy.

6.1.2.1 Risk analysis

XYZ Company periodically reviews lessons learned from product recalls, product audits, field returns
and repairs, complaints, scrap, rework, and includes them in risk analysis. The effectiveness of
these actions is evaluated, and actions are integrated in to XYZ Companys quality management
system. For details, refer to the Risk Management Procedure.
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6.2.4 Key initiatives

The management of XYZ Company establishes annual key initiatives, which include quality
objectives. The objectives are established via the Management Review Procedure and
communicated to all levels of the organization for use in establishing each functions and employees
annual key objectives. Quality objectives are measurable, include business performance indicators
reflecting requirements for products/services, and are consistent with the quality policy including the
commitment to continuous improvement. The use of quality objectives for facilitating continual
improvement is explained in the Continual Improvement Procedure.

8.0 Operation

8.1 Operational planning and control

8.1.1 Planning of product and service realization

XYZ Company has established and maintains a documented Product and Service Realization
Planning Procedure to ensure that processes and sub-processes are conducted under controlled
conditions. Planning of the realization processes is consistent with the other requirements of the
organizations quality management system.

8.3.2.3 Development of products with embedded software

XYZ Company maintains and follows a documented a software quality assurance process for
products with internally developed embedded software. XYZ Company uses an appropriate
assessment methodology to assess its software development process.

8.4.1 General

XYZ Company ensures that the purchasing process is controlled such that purchased products and
subcontracted services, which affect product/service quality, conform to specified requirements.

8.4.2.3.1 Automotive product-related software or automotive products with embedded

software
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XYZ Company require suppliers of software-related products, or products with embedded software
to maintain software quality assurance process for its products, this includes a software
development assessment methodology. The requirements within Section 8.3.2.3 of this manual also
apply to XYZ Company suppliers. For details refer to Section 8.3.2.3.
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Inspection and Test Procedure

1.0 Receiving Inspection and Test

1.1 All purchased material which influences the manufacture of, or is intended for use as
part of, deliverable products is subject to inspection and/or testing by Receiving
Inspection. Upon receipt of products, receiving personnel verify the quantity of
delivered units, check marking and identification of packages, and inspect all
packages for any signs of tampering or damage. If all these checks and inspections
are satisfactory, receiving personnel signs the delivery receipt. If not, any shortages
or damages are noted on all copies of the delivery receipts.

1.2 The received containers are then moved to the designated inspection area, a copy of
the purchase order is retrieved, and the packing slips are removed from the
containers. Upon opening the containers, the goods are verified against the
purchase order and the packing slip, and are examined visually for any signs of
damage. The purchase order is stamped RECEIVED and is signed and dated by
the receiving inspector. All receiving inspections are logged in the Receiving
Inspection Log.

1.3 On critical parts and components, as determined by the Quality Manager, a precision
inspection/test is performed. This type of inspection includes one or more of the
following:

review of material certificates, supplier inspection records, compliance certificates,

and any other relevant documentation delivered with the product

receipt of, and evaluation of, statistical data

random sampling based on statistical technique specified

100% Inspection/testing if necessary

visual inspection to detect any damage or other visible problems

performing measurements and testing against specified requirements

second or third party assessments or audits of supplier sites, when combined with
records of acceptable delivered product quality

part evaluation by a designated laboratory

another method agreed with the customer

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Results of such inspection/test, including recording the sample size and actual
measurements are recorded on the Inspection/Test & Audit Report

1.4 Where it is not practical to perform receiving inspection upon receipt, provisions are
made to perform source inspection at the suppliers facility.

1.5 The Quality Manager determines the extent and scope of receiving inspection based
on the importance of the item and the suppliers control methods and performance.
The Quality Manager may request that suppliers provide objective evidence of
conformance (i.e., material certifications, certificates of conformance, test data, first
article inspection and SPC data). Objective evidence provided by suppliers may be
used as the basis for reducing/waiving receiving and source inspection.

1.6 Upon acceptance, products are identified with an ACCEPT tag [green sticker] and
moved to stock. In the event that product which is designated for receiving inspection
is released to production due to urgency, it shall be positively identified and recorded
in receiving inspection records.

2.0 In-process Inspection and Test

2.1 In-process inspection/testing is conducted to ensure that the product/process

conforms to specified requirements. The inspection/testing is normally carried out by
production personnel. Random audits of the in-process inspection/testing process
are conducted by quality control personnel.

2.2 The Quality Manager determines the extent and scope of in-process
inspection/testing based on the importance of the item, control methods, and previous
performance.

3.0 Final Inspection and Test

3.1 For acceptance of completed products, final inspection/testing is utilized. This

includes a verification of satisfactory receiving and in-process inspections/tests, as
well as completion of the remaining inspections/tests to assure that the finished
products/processes conform to specified requirements. Products are not released,
processes are not approved until all inspection/test activities have been satisfactorily
completed and the appropriate documentation is available and authorized. All final
inspections are logged in the Final Inspection Log. On critical parts and components,
as determined by the Quality Manager, a Final Inspection/Test & Audit Report is
completed.

3.2 XYZ Company ensures the planned arrangement, to verify that the products and
service requirements have been satisfied, are aligned with the control plan and are
documented as specifies in the control plan.
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3.3 XYZ Company ensures that the planned arrangements for initial release of products
and services encompass product or services approval.

3.4 When changes occur after initial release, XYZ Company ensures that product or
services approvals are obtained in accordance with section 8.5.6.

3.5 A layout inspection and a functional verification to applicable customer engineering

material and performance standards is performed for each product as specified in the
control plans. The frequency of layout inspections is determined by the customer.
Results are available for customer review.

3.6 The Quality Manager determines the extent and scope of final inspection/testing
based on the importance of the item, control methods, and previous performance.

4.0 Inspection and Test Records

4.1 Inspection/test records, which show clearly whether the product/process has passed
or failed the defined acceptance criteria, are established and maintained.

5.0 Nonconforming Material/Products

5.1 All material/products that are found to be nonconforming are identified and
segregated and/or quarantined, and appropriately dispositioned per the Control of
Nonconforming Product Procedure.
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Corrective and Preventive Action Procedure

1.0 Initiation of Corrective/Preventive Actions

1.1 Corrective actions may be requested when a condition, which is adverse to quality or
which has the potential for product/process improvement is identified. This includes
nonconforming material received from a supplier.

1.2 Preventive actions may be requested when potential product/process problems are
identified.

1.3 Any employee of the company can initiate a corrective/preventive action request by
completing the top portion of the Corrective Action Request (CAR) form, but only the
Quality Manager can issue a Supplier Corrective Action Request (SCAR). The
Quality Manager records all CARs in the Corrective Action Status Log and SCARs in
the Supplier Corrective Action Status Log.

2.0 Customer Complaints

2.1 Marketing/Sales is responsible for receiving, processing, and responding to customer

complaints. All received customer complaints are recorded in the Customer
Complaints Status Log.

2.2 The Quality Manager evaluates every complaint and when relevant, requests
implementation of corrective actions from the responsible function. The Quality
Manager, in conjunction with the President and Sales, determines the appropriate
customer response.

2.3 Field failures are handled as described in the Servicing Procedure.

3.0 Analysis and Approvals

3.1 A thorough analysis of all related processes, operations, quality records and
specifications, which may have contributed to the deficiency, is conducted by the
responsible function. The investigation and analysis of the root cause and preventive
measures shall be fully documented by the group or individual assigned to the
problem. The analysis shall include review of all applicable data and examination of
product scrapped or reworked to determine the extent and cause of the problem and
analysis of trends in processes or performance of work to prevent nonconformances.

3.2 Analysis of corrective action and preventive action is used as input into management
reviews.
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3.3 At a minimum, the following problem-solving methods are used:

problem identification

containment

root cause identification

verification of effectiveness of corrective action

Additionally, the following methods may be used:

analysis of failure mode

capability studies

correlation diagrams

data collection

fish bone diagram (ishikawa diagram)

FMEA review

histograms

pareto analysis

probability charts

recording with corresponding graphic representations

stratification (separation of data and divisions into categories)

3.4 If a customer-prescribed problem-solving format exists, XYZ Company uses the

prescribed format.

3.5 All problems are evaluated in terms of potential impact on production costs, quality
costs, performance, reliability, safety, and customer satisfaction. All problems are
classified either minor or major. Resolutions to all corrective and preventive actions
are reviewed and approved by the Quality Manager. Where the response is
unsatisfactory, the corrective action request is re-issued. The Quality Manager
conducts periodic reviews/follow up to determine if the corrective and preventive
actions have been implemented and are effective.
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3.6 All department managers handle corrective /preventive actions in priority order. The
Quality Manager ensures that all action plans are carried out in a reasonable
timeframe relative to the severity of the problem.

4.0 Preventive Actions

4.1 When corrective actions are implemented or when a potentially serious

nonconformance is identified, similar parts, products, and processes are analyzed to
determine the required steps for effective implementation of preventive actions.

5.0 Records

5.1 All CARs, SCARs, customer complaints, software problem reports, surveys, returned
product and post-production records, incident reports, advisory notices, recall
records, and their resolution including their verification, are filed and maintained.

5.2 The risk management files are updated as appropriate.

QUALITY SYSTEMS INNOVATIONS, INC.

www.qsinnovations.com

Phone: 570-350-2937

Email: qsiinc@ptd.net