Quality Manual - Whittington & Associates€¦ · Web viewquality manual, which includes: a) the scope of QMS, including details of and justification for any exclusions; b) references

Quality Manual

(Revise the policies expressed in this template to be appropriate for your quality management system)

(Add references within this manual to procedures and other related documents or edit the attachment)

(Edit Title Page)

(Include company name, logo, address, etc.)(Change entries in document footer)(TOC is auto generated from section headers, i.e., H1, H2, H3(Click at top of TOC to “Update entire table” after document revisions)

QualityManual

Whittington & Associates Page 1 of 67 Revision 0.0

Quality Manual

Contents1. Company Name.......................................................................................................................................9

1.1 Company Overview............................................................................................................................9

1.2 Organization Chart.............................................................................................................................9

1.3 Management Responsibilities............................................................................................................9

2. Management System...............................................................................................................................9

2.1 System Scope.....................................................................................................................................9

2.2 Scope Map.........................................................................................................................................9

2.3 System Exclusions..............................................................................................................................9

3. Policies and Objectives............................................................................................................................9

3.1 Quality Principles...............................................................................................................................9

3.1.1 Customer Focus........................................................................................................................10

3.1.2 Management Leadership..........................................................................................................10

3.1.3 Engagement of People..............................................................................................................10

3.1.4 Process Approach.....................................................................................................................10

3.1.5 Improvement............................................................................................................................10

3.1.6 Evidence-based Decision Making..............................................................................................10

3.1.7 Relationship Management........................................................................................................10

3.2 Quality Policy...................................................................................................................................10

3.3 Quality Objectives............................................................................................................................10

4. Context of the Organization..................................................................................................................11

4.1 Understanding the Organization and its Context.............................................................................11

4.2 Understanding the Needs and Expectations of Interested Parties..................................................11

4.3 Determining the Scope of the Quality Management System...........................................................11

4.3.1 Determining Scope of the Quality Management System – Supplemental................................12

4.3.2 Customer-Specific Requirements..............................................................................................12

4.4 Quality Management System and its Processes..............................................................................12

4.4.1 (untitled)...................................................................................................................................12

4.4.1.1 Conformance of Products and Process..............................................................................13

4.4.1.2 Product Safety...................................................................................................................13

4.4.2 (untitled)...................................................................................................................................14


Quality Manual

5. Leadership.............................................................................................................................................14

5.1 Leadership and Commitment..........................................................................................................14

5.1.1 General.....................................................................................................................................14

5.1.1.1 Corporate Responsibility....................................................................................................14

5.1.1.2 Process Effectiveness and Efficiency..................................................................................15

5.1.1.3 Process Owners.................................................................................................................15

5.1.2 Customer Focus........................................................................................................................15

5.2 Policy...............................................................................................................................................15

5.2.1 Establishing the Quality Policy..................................................................................................15

5.2.2 Communicating the Quality Policy............................................................................................15

5.3 Organizational Roles, Responsibilities, and Authorities...................................................................15

5.3.1 Organizational Roles, Responsibilities, and Authorities – Supplemental..................................16

5.3.2 Responsibility and Authority for Product Requirements and Corrective Actions.....................16

6. Planning.................................................................................................................................................17

6.1 Actions to Address Risks and Opportunities....................................................................................17

6.1.1 (untitled)...................................................................................................................................17

6.1.2 (untitled)...................................................................................................................................17

6.1.2.1 Risk Analysis.......................................................................................................................17

6.1.2.2 Preventive Action...............................................................................................................18

6.1.2.3 Contingency Plans..............................................................................................................18

6.2 Quality Objectives and Planning to Achieve Them..........................................................................19

6.2.1 (untitled)...................................................................................................................................19

6.2.2 (untitled)...................................................................................................................................19

6.2.2.1 Quality Objectives and Planning to Achieve Them - Supplemental...................................19

6.3 Planning for Changes.......................................................................................................................20

7. Support..................................................................................................................................................20

7.1 Resources........................................................................................................................................20

7.1.1 General.....................................................................................................................................20

7.1.2 People.......................................................................................................................................20

7.1.3 Infrastructure............................................................................................................................20

7.1.3.1 Plant, Facility, and Equipment Planning.................................................................................21

7.1.4 Environment for the Operation of Processes............................................................................21


Quality Manual

7.1.4.1 Environment for the Operation of Processes - Supplemental............................................21

7.1.5 Monitoring and Measuring Resources......................................................................................22

7.1.5.1 General..............................................................................................................................22

7.1.5.1.1 Measurement Systems Analysis..................................................................................22

7.1.5.2 Measurement Traceability.................................................................................................22

7.1.5.2.1 Calibration/Verification Records.................................................................................23

7.1.5.3 Laboratory Requirements..................................................................................................23

7.1.5.3.1 Internal Laboratory.....................................................................................................23

7.1.5.3.2 External Laboratory.....................................................................................................24

7.1.6 Organizational Knowledge........................................................................................................24

7.2 Competence....................................................................................................................................25

7.2.1 Competence – Supplemental....................................................................................................25

7.2.2 Competence – On-The-Job Training..........................................................................................25

7.2.3 Internal Auditor Competency...................................................................................................25

7.2.4 Second-Party Auditor Competency...........................................................................................26

7.3 Awareness.......................................................................................................................................27

7.3.1 Awareness – Supplemental.......................................................................................................27

7.3.2 Employee Motivation and Empowerment................................................................................27

7.4 Communication...............................................................................................................................27

7.5 Documented Information................................................................................................................28

7.5.1 General.....................................................................................................................................28

7.5.1.1 Quality Management System Documentation...................................................................28

7.5.2 Creating and Updating..............................................................................................................28

7.5.3 Control of Documented Information........................................................................................28

7.5.3.1 (untitled)............................................................................................................................28

7.5.3.2 (untitled)............................................................................................................................28

7.5.3.2.1 Record Retention........................................................................................................29

7.5.3.2.2 Engineering Specifications..........................................................................................29

8. Operation..............................................................................................................................................30

8.1 Operational Planning and Control...................................................................................................30

8.1.1 Operational Planning and Control – Supplemental...................................................................30

8.1.2 Confidentiality..........................................................................................................................31


Quality Manual

8.2 Requirements for Products and Services.........................................................................................31

8.2.1 Customer Communication........................................................................................................31

8.2.1.1 Customer Communication – Supplemental.......................................................................31

8.2.2 Determining the Requirements for Products and Services.......................................................31

8.2.2.1 Determining the Requirements for Products and Services - Supplemental.......................31

8.2.3 Review of the Requirements for Products and Services...........................................................32

8.2.3.1 (untitled)............................................................................................................................32

8.2.3.1.1 Review of the Requirements for Products and Services - Supplemental....................32

8.2.3.1.2 Customer-Designated Special Characteristics.............................................................32

8.2.3.1.3 Organization Manufacturing Feasibility......................................................................32

8.2.3.2 (untitled)............................................................................................................................33

8.2.4 Changes to Requirements for Products and Services...............................................................33

8.3 Design and Development of Products and Services.........................................................................33

8.3.1 General.....................................................................................................................................33

8.3.1.1 Design and Development of Products and Services – Supplemental.................................33

8.3.2 Design and Development Planning...........................................................................................33

8.3.2.1 Design and Development Planning – Supplemental..........................................................34

8.3.2.2 Product Design Skills..........................................................................................................34

8.3.2.3 Development of Products with Embedded Software.........................................................34

8.3.3 Design and Development Inputs...............................................................................................34

8.3.3.1 Product Design Input.........................................................................................................35

8.3.3.2 Manufacturing Process Design Input.................................................................................35

8.3.3.3 Special Characteristics.......................................................................................................36

8.3.4 Design and Development Controls...........................................................................................36

8.3.4.1 Monitoring.........................................................................................................................37

8.3.4.2 Design and Development Validation..................................................................................37

8.3.4.3 Prototype Program............................................................................................................37

8.3.4.4 Product Approval Process..................................................................................................37

8.3.5 Design and Development Outputs............................................................................................37

8.3.5.1 Design and Development Outputs – Supplemental...........................................................38

8.3.5.2 Manufacturing Process Design Output..............................................................................38

8.3.6 Design and Development Changes...........................................................................................39


Quality Manual

8.3.6.1 Design and Development Changes....................................................................................39

8.4 Control of Externally Provided Processes, Products, and Services...................................................40

8.4.1 General.....................................................................................................................................40

8.4.1.1 General - Supplemental.....................................................................................................40

8.4.1.2 Supplier Selection Process.................................................................................................40

8.4.1.3 Customer-Directed Sources...............................................................................................41

8.4.2 Type and Extent of Control.......................................................................................................41

8.4.2.1 Type and Extent of Control - Supplemental.......................................................................41

8.4.2.2 Statutory and Regulatory Requirements............................................................................42

8.4.2.3 Supplier Quality Management System Development........................................................42

8.4.2.3.1 Automotive Product-Related Software or Automotive Products with Embedded Software....................................................................................................................................42

8.4.2.4 Supplier Monitoring...........................................................................................................42

8.4.2.4.1 Second-Party Audits....................................................................................................43

8.4.2.5 Supplier Development.......................................................................................................43

8.4.3 Information for External Providers...........................................................................................44

8.4.3.1 Information for External Providers – Supplemental...........................................................44

8.5 Production and Service Provision....................................................................................................44

8.5.1 Control of Production and Service Provision............................................................................44

8.5.1.1 Control Plan.......................................................................................................................45

8.5.1.2 Standardized Work – Operator Instructions and Visual Standards....................................46

8.5.1.3 Verification of Job Set-ups.................................................................................................46

8.5.1.4 Verification After Shutdown..............................................................................................46

8.5.1.5 Total Productive Maintenance...........................................................................................46

8.5.1.6 Management of Production Tooling and Manufacturing, Test, Inspection Tooling and Equipment.....................................................................................................................................47

8.5.1.7 Production Scheduling.......................................................................................................48

8.5.2 Identification and Traceability..................................................................................................48

8.5.2.1 Identification and Traceability – Supplemental..................................................................48

8.5.3 Property belonging to Customers or External providers...........................................................49

8.5.4 Preservation..............................................................................................................................49

8.5.4.1 Preservation – Supplemental.............................................................................................49

8.5.5 Post-delivery activities..............................................................................................................50


Quality Manual

8.5.5.1 Feedback of Information from Service...............................................................................50

8.5.5.2 Service Agreement with Customer....................................................................................50

8.5.6 Control of changes....................................................................................................................50

8.5.6.1 Control of Changes – Supplemental...................................................................................50

8.5.6.1.1 Temporary Change of Process Controls......................................................................52

8.6 Release of Products and Services....................................................................................................53

8.6.1 Release of Products and Services - Supplemental....................................................................53

8.6.2 Layout Inspection and Functional Testing.................................................................................53

8.6.3 Appearance Items.....................................................................................................................53

8.6.4 Verification and Acceptance of Conformity of Externally Provided Products and Services......54

8.6.5 Statutory and Regulatory Conformity.......................................................................................54

8.6.6 Acceptance Criteria...................................................................................................................54

8.7 Control of Nonconforming Outputs.................................................................................................54

8.7.1 (untitled)...................................................................................................................................54

8.7.1.1 Customer Authorization for Concession............................................................................55

8.7.1.2 Control of Nonconforming Product – Customer-Specified Process...................................55

8.7.1.3 Control of Suspect Product................................................................................................55

8.7.1.4 Control of Reworked Product............................................................................................55

8.7.1.5 Control of Repaired Product..............................................................................................55

8.7.1.6 Customer Notification........................................................................................................56

8.7.1.7 Nonconformity Product Disposition...................................................................................56

8.7.2 (untitled)...................................................................................................................................56

9. Performance Evaluation........................................................................................................................56

9.1 Monitoring, Measurement, Analysis, and Evaluation......................................................................56

9.1.1 General.....................................................................................................................................56

9.1.1.1 Monitoring and Measurement of Manufacturing Processes.............................................57

9.1.1.2 Identification of Statistical Tools........................................................................................57

9.1.1.3 Application of Statistical Concepts.....................................................................................57

9.1.2 Customer Satisfaction...............................................................................................................58

9.1.2.1 Customer Satisfaction – Supplemental..............................................................................58

9.1.3 Analysis and Evaluation............................................................................................................58

9.1.3.1 Prioritization......................................................................................................................59


Quality Manual

9.2 Internal Audit...................................................................................................................................59

9.2.1 (untitled)...................................................................................................................................59

9.2.2 (untitled)...................................................................................................................................59

9.2.2.1 Internal Audit Program......................................................................................................59

9.2.2.2 Quality Management System Audit...................................................................................60

9.2.2.3 Manufacturing Process Audit.............................................................................................60

9.2.2.4 Product Audit.....................................................................................................................60

9.3 Management Review.......................................................................................................................60

9.3.1 General.....................................................................................................................................60

9.3.1.1 Management Review – Supplemental...............................................................................60

9.3.2 Management Review Inputs.....................................................................................................60

9.3.2.1 Management Review Inputs – Supplemental....................................................................61

9.3.3 Management Review Outputs..................................................................................................61

9.3.3.1 Management Review Outputs – Supplemental.................................................................62

10. Improvement.......................................................................................................................................62

10.1 General..........................................................................................................................................62

10.2 Nonconformity and Corrective Action...........................................................................................62

10.2.1 (untitled).................................................................................................................................62

10.2.2 (untitled).................................................................................................................................63

10.2.3 Problem Solving......................................................................................................................63

10.2.4 Error-Proofing.........................................................................................................................63

10.2.5 Warranty Management System..............................................................................................64

10.2.6 Customer Complaints and Field Failure Test Analysis.............................................................64

10.3 Continual improvement.................................................................................................................64

10.3.1 Continual Improvement – Supplemental................................................................................64

Appendix: Document References..............................................................................................................65

Change History..........................................................................................................................................67


Quality Manual

1. Company Name

1.1 Company Overview (add description from website or marketing brochure)

1.2 Organization Chart (add chart with functional areas, but without manager names)

1.3 Management Responsibilities(add high-level summary of top management responsibilities)

2. Management System

2.1 System Scope(Replace with your scope statement)

We design, manufacture, and maintain XXX products at our XXX site for the automotive industry. We have not excluded any requirements of the IATF 16949:2016 standard.

(note that supporting functions such as design centers, corporate headquarters, and distribution centers, whether onsite or remote, must be included in the Scope of your quality management system)

2.2 Scope Map (add a diagram that depicts the overall process sequence and interaction)

2.3 System Exclusions (only permissible exclusion is “product” design in clause 8.3)(“manufacturing process” design in clause 8.3 cannot be excluded)

3. Policies and Objectives

3.1 Quality Principles Our top management recognizes that to successfully lead and operate <company name>, it is necessary that they direct and control our organization in a systematic manner. Our business success depends on operating a quality management system focused on continually improving performance while addressing the needs of our customers.

Our quality management system is guided by, and management is committed to, these seven Quality Management Principles on which ISO 9001:2015, and therefore IATF 16949:2016, are based:


Quality Manual

3.1.1 Customer Focus We depend on our customers for continued business success. Therefore, we want to understand their needs, meet their requirements, and strive to exceed their expectations.

3.1.2 Management Leadership Management recognizes that they need to establish unity of purpose and direction for our organization. We are committed to creating and maintaining conditions in which people are engaged in achieving our quality objectives.

3.1.3 Engagement of People Management recognizes that our most valuable resource is our people. We need competent, empowered, and engaged employees at all levels because they are essential to enhance our capability to create and deliver value.

3.1.4 Process Approach Management recognizes that consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system. We have implemented the process approach to focus on the methods, resources, measures, risks, and controls needed to transform our process inputs into quality outputs.

3.1.5 Improvement Management is committed to improvement, because it is essential for us to maintain current levels of performance, to react to changes in internal and external conditions, and to create new opportunities.

3.1.6 Evidence-based Decision Making Management understands that decision-making can be a complex process and involves some degree of uncertainty. It often involves multiple types and sources of inputs, as well as, their interpretation, which can be subjective. We recognize it is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence, and data analysis will lead to greater objectivity and confidence in our decision making.

3.1.7 Relationship ManagementManagement understands that relevant interested parties influence our performance. We are aware our sustained success is more likely to be achieved when we manage our relationships with supplier, external provider, and partner networks.

3.2 Quality Policy (Replace with your quality policy statement)

We are committed to meeting customer requirements, providing on-time delivery, supplying high quality products and services, and continually improving the effectiveness of our QMS.

3.3 Quality Objectives (Replace with your quality objectives)

We have three primary quality objectives:


Quality Manual

on-time delivery; on-target cost; high quality.

Specific, measurable targets have been established for these quality objectives and the trends are analyzed at our management review meetings.

NOTE: The policies in this manual related to ISO 9001:2015 requirements are expressed in regular font. The additional policies unique to IATF 16949:2016 requirements are shown in italics.

4. Context of the Organization

4.1 Understanding the Organization and its ContextWe have determined the external and internal issues that are relevant to our purpose and strategic direction, and that may affect our ability to achieve the intended results of our quality management system (also referred to as “QMS” in this quality manual).

We monitor and review information about these external and internal issues, and discuss their changes and impacts at our management review meetings. We consider issues that may be positive and negative factors or conditions. We understand that external issues can arise from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. We also understand that internal issues can relate to our values, culture, knowledge, and performance.

4.2 Understanding the Needs and Expectations of Interested PartiesDue to their effect, or potential effect, on our ability to consistently provide products and services that meet customer and applicable statutory and regulatory (legal) requirements, we have determined the:

a) interested parties that are relevant to our QMS;

b) requirements of these interested parties that are relevant to our QMS.

We monitor and review information about these interested parties and their relevant requirements. We consider feedback from these interested parties at our management review meetings.

4.3 Determining the Scope of the Quality Management SystemWe have determined the boundaries and applicability of our QMS to determine its scope. When we determined this scope, we considered:

a) external and internal issues referred to in 4.1;

b) requirements of relevant interested parties referred to in 4.2;

c) our products and services.


Quality Manual

We have applied all the IATF 16949:2016 requirements that are applicable within the scope of our QMS. The scope statement is documented, maintained, and available within our organization and to all relevant interested parties.

The scope statement in section 2.1 includes the types of products and services covered, and provides justification for any IATF 16949:2016 requirements that were determined as not applicable for our QMS.

We have determined that the excluded requirements (see 2.3) in our scope statement (see 2.1) do not affect our ability, or responsibility, to ensure the conformity of our products and services, as well as, the enhancement of customer satisfaction.

4.3.1 Determining Scope of the Quality Management System – SupplementalOur supporting functions, whether onsite or remote (e.g., design centers, corporate headquarters, and distribution centers) are included in the scope of our quality management system.

We understand that the only permitted scope exclusion is for product design and development, see section 8.3. That exclusion must be justified and maintained as documented information.

Our manufacturing process design is included in our QMS scope.

4.3.2 Customer-Specific RequirementsCustomer-specific requirements have been evaluated and are included in our QMS scope.

4.4 Quality Management System and its Processes

4.4.1 (untitled)We have established, implemented, maintain, and continually improve our QMS, including the processes needed and their interactions, in accordance with the IATF 16949:2016 requirements.

We have determined the processes needed for our QMS and their application throughout our organization. Our approach has been to:

a) determine the inputs required and the outputs expected from these processes;

b) determine the sequence and interaction of these processes;

c) determine and apply the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes;

d) determine the resources needed for these processes (and ensure their availability);

e) assign the responsibilities and authorities for these processes;

f) address the risks and opportunities as determined in accordance with the requirements of 6.1;

g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;


Quality Manual

h) improve the processes and our quality management system.

See the Scope Map in section 2.2 for a description of the process sequence and interaction.

4.4.1.1 Conformance of Products and ProcessWe ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements (see 8.4.2.2).

4.4.1.2 Product Safety We have documented the processes for management of product-safety related products and manufacturing processes, which include, but are not limited to the following, as applicable:

a) identification of statutory and regulatory product-safety requirements;

b) customer notification of requirements in item a);

c) special approvals for design FMEA;

d) identification of product safety-related characteristics;

e) Identification and controls of safety-related product characteristics and at the point of manufacture;

f) special approval of control plans and process FMEAs;

g) reaction plans (see 9.1.1.1);

h) defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification;

i) training identified by organization or customer for personnel involved in product-safety related products and associated manufacturing processes;

j) changes of product or process must be approved prior to implementation, including evaluation of potential effects on product safety from process and product changes (see 8.3.6);

k) transfer of requirements regarding product safety throughout the supply chain, including customer-designated sources (see 8.4.3.1);

l) product traceability by manufactured lot (at a minimum) throughout the supply chain (see 8.5.2.1);

m) lessons learned for new product introduction.

We understand that special approval is an additional approval by the function (typically the customer) that is responsible to approve such documents with safety-related content.


Quality Manual

4.4.2 (untitled)To the extent necessary, we:

a) maintain documented information (documents) to support the operation of our processes;

b) retain documented information (records) to have confidence that the processes are being carried out as planned.

5. Leadership

5.1 Leadership and Commitment

5.1.1 GeneralOur top management demonstrates its leadership and commitment with respect to our QMS by:

a) taking accountability for the effectiveness of the quality management system;

b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;

c) ensuring the integration of our QMS requirements into our business processes;

d) promoting the use of the process approach and risk-based thinking;

e) ensuring that the resources needed for our QMS are available;

f) communicating the importance of effective quality management and of conforming to the QMS requirements;

g) ensuring that the QMS achieves its intended results;

h) engaging, directing, and supporting persons to contribute to the effectiveness of the QMS;

i) promoting improvement;

j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

5.1.1.1 Corporate ResponsibilityWe have defined and implemented corporate responsibility policies, including an anti-bribery policy, employee code of conduct, and ethics escalation policy (whistle-blowing policy).


Quality Manual

5.1.1.2 Process Effectiveness and EfficiencyTop management reviews product realization processes and support processes to evaluate and improve their effectiveness and efficiency. Results of these process review activities are included as input to the management review (see 9.3.2.1).

5.1.1.3 Process OwnersTop management has identified process owners who are responsible for managing the processes and related outputs. Our process owners understand their roles and are competent to perform those roles (see 7.2).

5.1.2 Customer FocusOur top management demonstrates its leadership and commitment with respect to customer focus by ensuring that:

a) customer and applicable legal requirements are determined, understood, and consistently met;

b) risks and opportunities that can affect conformity of products and services, and the ability to enhance customer satisfaction, are determined and addressed;

c) our focus on enhancing customer satisfaction is maintained.

5.2 Policy

5.2.1 Establishing the Quality PolicyTop management has established, implemented, and maintains a quality policy that:

a) is appropriate to the purpose and context of our organization and supports its strategic direction;

b) provides a framework for setting quality objectives;

c) includes a commitment to satisfy applicable requirements;

d) includes a commitment to continual improvement of the quality management system.

5.2.2 Communicating the Quality PolicyOur quality policy (see 3.2) is:

a) available and maintained as documented information;

b) communicated, understood, and applied within our organization;

c) available to relevant interested parties.

5.3 Organizational Roles, Responsibilities, and AuthoritiesTop management ensures that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization.


Quality Manual

Top management has assigned the responsibility and authority for:

a) ensuring that the QMS conforms to the IATF 16949:2016 requirements;

b) ensuring that the processes are delivering their intended outputs;

c) reporting on the performance of the QMS and on opportunities for improvement (see 10.1), especially to top management;

d) ensuring the promotion of customer focus throughout our organization;

e) ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

5.3.1 Organizational Roles, Responsibilities, and Authorities – SupplementalTop management has assigned personnel with the responsibility and authority to ensure customer requirements are met. These assignments are documented and include, but are not limited to:

selection of special characteristics setting of quality objectives and related training corrective and preventive actions product design and development capacity analysis logistics information customer scorecards customer portals.

5.3.2 Responsibility and Authority for Product Requirements and Corrective ActionsTop management ensures that:

a) personnel responsible for conformity to product requirements have authority to stop shipment and stop production to correct quality problems;

If it is not possible to stop production immediately, the affected batch will be contained and shipment to the customer prevented.

b) personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform to requirements to ensure that nonconforming product is not shipped to the customer and all potential nonconforming product is identified and contained;

c) production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements.


Quality Manual

6. Planning

6.1 Actions to Address Risks and Opportunities

6.1.1 (untitled)We have considered the issues referred to in 4.1, and the requirements referred to in 4.2, and determined the risks and opportunities that need to be addressed to:

a) give assurance that our QMS can achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects;

d) achieve improvement.

6.1.2 (untitled)We plan:

a) actions to address these risks and opportunities;

b) how to:

1) integrate and implement the actions into our QMS processes (see 4.4);

2) evaluate the effectiveness of these actions.

The actions taken to address these risks and opportunities will be proportionate to the potential impact on the conformity of our products and services.

Our options to address risks can include avoiding risk, taking risk to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

We understand that opportunities can lead to adopting new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology, and other desirable and viable possibilities to address our needs or those of our customers.

6.1.2.1 Risk AnalysisWe include in our risk analysis, at a minimum, the lessons learned from:

product recalls and product audits field returns and repairs complaints, scrap, and rework

We retain documented information (records) as evidence of the results of risk analysis.


Quality Manual

6.1.2.2 Preventive ActionWe determine and implement actions to eliminate the causes of potential nonconformities to prevent their occurrence. Preventive actions are appropriate to the severity of the potential issues.

We have established a process to lessen the impact of negative effects of risk, including the following:

a) determine potential nonconformities and their causes;

b) evaluate the need for action to prevent occurrence of nonconformities;

c) determine and implement action needed;

d) document action taken;

e) review effectiveness of preventive action taken;

f) use lessons learned to prevent recurrence in similar processes (see 7.1.6).

6.1.2.3 Contingency PlansFor contingency planning, we:

a) Identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that customer requirements are met;

b) define contingency plans according to risk impact to the customer;

c) Prepare contingency plans for continuity of supply in event of any of the following:

key equipment failures (see 8.5.6.1.1) interruption from externally provided products, processes, and services; recurring natural disaster; fire; utility interruptions; labor shortages; infrastructure disruptions;

d) include as a supplement to our contingency plans, a notification process to customer and other interested parties for the extent and duration of any situation impacting customer operations;

e) periodically test the contingency plans for effectiveness;

f) conduct contingency plan reviews (at least annually) using a multi-disciplinary team including top management, and update the plan as required;

g) document the contingency plans and retain documented information (records) describing any revisions, including the persons who authorized the changes.


Quality Manual

Our contingency plans include validating that the manufactured product continues to meet customer specifications after restart of production following an emergency in which production was stopped and if the regular shutdown processes were not followed.

6.2 Quality Objectives and Planning to Achieve Them

6.2.1 (untitled)We have established quality objectives at relevant functions, levels, and processes needed for our QMS. The quality objectives are:

a) consistent with the quality policy;

b) measurable;

c) based on applicable requirements;

d) relevant to conformity of products and services and to enhancement of customer satisfaction;

e) monitored;

f) communicated;

g) updated as appropriate.

We maintain documented information on the quality objectives.

6.2.2 (untitled)When planning how to achieve our quality objectives, we determine:

a) what will be done;

b) what resources will be required;

c) who will be responsible;

d) when it will be completed;

e) how the results will be evaluated.

6.2.2.1 Quality Objectives and Planning to Achieve Them - SupplementalTop Management ensures that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout our organization.

We consider the results of our review of relevant interested parties (and their relevant requirements) when establishing our annual quality objectives and related performance targets (internal and external).


Quality Manual

6.3 Planning for ChangesWhen we determine the need for changes to our QMS, the changes are carried out in a planned manner (see 4.4).

We consider the:

a) purpose of the changes and their potential consequences;

b) integrity of the quality management system;

c) availability of resources;

d) allocation or reallocation of responsibilities and authorities.

7. Support

7.1 Resources

7.1.1 GeneralWe determine and provide the resources needed for the establishment, implementation, maintenance, and continual improvement of our quality management system.

We consider:

a) the capabilities of, and constraints on, existing internal resources;

b) what needs to be obtained from external providers.

7.1.2 PeopleWe determine and provide the persons necessary for the effective implementation of our QMS and for the operation and control of its processes.

7.1.3 InfrastructureWe determine, provide, and maintain the infrastructure necessary for the operation of our processes and to achieve conformity of our products and services.

Our infrastructure includes:

a) buildings and associated utilities;

b) equipment, including hardware and software;

c) transportation resources;

d) information and communication technology.


Quality Manual

7.1.3.1 Plant, Facility, and Equipment PlanningWe use a multi-disciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans.

In designing plant layouts, we:

a) optimize material flow, materials handling, and value-added use of floor space, including control of nonconforming product, and

b) facilitate synchronous material flow, as applicable.

We develop and implement methods to evaluate manufacturing feasibility for new products or new operations. These assessments include capacity planning. Our methods are applicable for evaluating the proposed changes to existing operations. We maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance (see 8.5.1.1), and verification of job set-ups (see 8.5.1.3).

These assessments of manufacturing feasibility, and evaluation of capacity planning, are inputs to management reviews (see 9.3).

We apply lean manufacturing principles during our plant, facility, and equipment planning. We also apply the policies in 7.1.3.1 to onsite supplier activities, as applicable.

7.1.4 Environment for the Operation of ProcessesWe determine, provide, and maintain the environment necessary for the operation of our processes and to achieve conformity of our products and services.

A suitable operating environment may be a combination of human and physical factors, such as:

a) social (e.g., non-discriminatory, calm, non-confrontational);

b) psychological (e.g., stress-reducing, burnout prevention, emotionally protective);

c) physical (e.g., temperature, heat, humidity, light, airflow, hygiene, noise).

We understand that where third-party ISO 45001 certification is recognized, it may be used to demonstrate our conformity to the personnel safety aspects of this IATF 16949:2016 requirement.

7.1.4.1 Environment for the Operation of Processes - SupplementalWe maintain our premises in a state of order, cleanliness, and repair that is consistent with our product and manufacturing process needs.


Quality Manual

7.1.5 Monitoring and Measuring Resources7.1.5.1 GeneralWe determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of our products and services to requirements.

We ensure that the resources provided are:

a) suitable for the specific type of monitoring and measurement activities being undertaken;

b) maintained to ensure their continuing fitness for their purpose.

We retain appropriate documented information (records) as evidence of fitness for purpose of the monitoring and measurement resources.

7.1.5.1.1 Measurement Systems AnalysisWe conduct statistical studies to analyze the variation present in the results of each type of inspection, measurement, and test equipment identified in the control plan.

We use analytical methods and acceptance criteria that conform to those in reference manuals on Measurement Systems Analysis (MSA). We may use other analytical methods and acceptance criteria if they are approved by the customer.

We retain records of customer acceptance of alternative methods, along with results from alternative measurement systems analysis (see 9.1.1.1).

We focus our prioritization of MSA studies on critical or special product or process characteristics.

7.1.5.2 Measurement TraceabilityWhen measurement traceability is a requirement, or considered to be an essential part of providing confidence in the validity of measurement results, our measuring equipment is:

a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification is retained as documented information (records);

b) identified to determine their status;

c) safeguarded from adjustments, damage, or deterioration that would invalidate the calibration status and subsequent measurement results.

We determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and we take appropriate action as necessary.

We understand that a number or another identifier traceable to the device calibration record meets the intent of this ISO 9001:2015 requirement.


Quality Manual

7.1.5.2.1 Calibration/Verification RecordsWe have a documented process for managing our calibration/verification records.

We retain records of calibration/verification activity for all gauges and measuring and test equipment (including employee-owned equipment relevant for measuring, and customer-owned or on-site supplier-owned equipment) needed to provide evidence of conformity to internal, legislative and regulatory, and customer-defined requirements.

We ensure that calibration/verification activities and records include the following details:

a) revisions following engineering changes that impact measurement systems;

b) any out-of-specification readings as received for calibration/verification;

c) an assessment of the risk of intended use of product caused by the out-of-specification condition;

d) when a piece of inspection measurement or test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, we retain documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment. The records include the associated standard’s last calibration date and the next due date on the calibration report;

e) notification to the customer if suspect product or material has been shipped;

f) statements of conformity to specification after calibration/verification;

g) verification that the software version used for product and process control is as specified;

h) records of calibration and maintenance activities for all gauging (including employee-owned, customer-owned, or onsite supplier-owned equipment);

i) production-related software verification used for product and process control, including software installed on employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment.

7.1.5.3 Laboratory Requirements

7.1.5.3.1 Internal LaboratoryWe have defined the scope for our internal laboratory to include its capability to perform required inspection, test, or calibration services. The laboratory scope is included in the QMS documentation.

Our laboratory has specified and implemented:

a) adequacy of the laboratory technical procedures;

b) competency of laboratory personnel


Quality Manual

c) test of product;

d) capability to perform these services correctly, traceable to relevant process standard (e.g., ASTM);

When no national or international standard is available, we will define and implement a methodology to verify measurement system capability;

e) customer requirements, if any;

f) review of related records.

We understand that third-party accreditation to ISO 17025 (or equivalent) may be used to demonstrate in-house laboratory conformity to this IATF 16949:2016 requirement.

7.1.5.3.2 External LaboratoryAny external/commercial/independent lab facilities we use for inspection, test, or calibration will have a defined laboratory scope that includes the capability to perform required inspection, test, or calibration, and either:

accreditation to ISO 17025 or national equivalent and include relevant inspection, test, or calibration service in the scope of the accreditation; the certificate of calibration or test report must include the mark of national accreditation body, or

evidence that the external laboratory is acceptable to the customer.

We understand that such evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that laboratory meets the intent of ISO 17025 or national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment.

The equipment manufacturer may perform the calibration services when a qualified laboratory is not available for a given piece of equipment. In such cases, we ensure that the requirements in section 7.1.5.3.1 have been met.

We understand that use of calibration services other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation.

7.1.6 Organizational KnowledgeWe determine the knowledge necessary for the operation of our processes and to achieve conformity of our products and services. This knowledge is maintained and made available to the extent necessary.

When addressing changing needs and trends, we consider our current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.

We understand that our organizational knowledge is generally gained by experience. It is information that is used and shared to achieve our objectives. Our organizational knowledge is based on:


Quality Manual

a) internal sources (e.g., intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; and the results of improvements in processes, products, and services);

b) external sources (e.g., standards; academia; conferences; and gathering knowledge from customers or external providers).

7.2 CompetenceWe ensure the necessary level of competence for our organization by:

a) determining the necessary competence of persons doing work under our control that affects the performance and effectiveness of our quality management system;

b) ensuring that these persons are competent based on appropriate education, training, or experience;

c) where applicable, taking actions to acquire the necessary competence, and evaluating the effectiveness of the actions taken;

d) retaining appropriate documented information (records) as evidence of competence.

Our actions may include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons.

7.2.1 Competence – SupplementalWe have established and maintain a documented process for identifying training needs, including awareness (see 7.3.1) and achieving competence of all personnel performing activities affecting conformity to product and process requirements.

We qualify, as required, the personnel performing specific assigned tasks, with particular attention to the satisfaction of customer requirements.

7.2.2 Competence – On-The-Job TrainingWe provide on-the-job training (which includes customer requirements training) for personnel in any new or modified responsibilities affecting conformity to quality requirements, internal requirements, or regulatory or legislative requirements. This OJT includes contract or agency personnel.

The level of detail required for the OJT is commensurate with the level of education of the personnel and the complexity of tasks they are required to perform for their daily work.

We inform the persons whose work can affect quality about the consequences of a nonconformity to customer requirements.

7.2.3 Internal Auditor CompetencyWe maintain a documented process to verify that internal auditors are competent, considering any customer-specific requirements. We rely on ISO 19011 for guidance on auditor competencies.


Quality Manual

We maintain a list of qualified internal auditors.

Our QMS, manufacturing process, and product auditors must be able to demonstrate following competencies (understanding of):

a) automotive process approach for auditing, including risk-based thinking;

b) applicable customer-specific requirements;

c) applicable ISO 9001:2015 and IATF 16949:2016 requirements related to the audit scope;

d) applicable core tool requirements related to the audit scope;

e) how to plan, conduct, report, and close out audit findings.

Our manufacturing process auditors must also demonstrate a technical understanding of relevant manufacturing processes to be audited, including process risk analysis (e.g., PFMEA) and control plan.

Our product auditors must also demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity.

We retain documented information (records) of the trainer’s competency with the above requirements.

We demonstrate maintenance of, and improvement in, internal auditor competence through:

f) executing a minimum number of audits per year; and

g) maintaining knowledge of relevant requirements based on:

internal changes (e.g., process technology, product technology) and external changes (e.g., ISO 9001, IATF 16949, core tools, and customer specific requirements).

7.2.4 Second-Party Auditor Competency We demonstrate the competence of auditors undertaking second-party audits. They must meet customer specific requirements for auditor qualification and demonstrate the following core competencies, including an understanding of:

a) automotive process approach to auditing, including risk-based thinking;

b) applicable customer and organization specific requirements;

c) applicable ISO 9001 and IATF 16949 requirements related to scope of audit;

d) applicable manufacturing processes to be audited, including PFMEA and control plan;

e) applicable core tool requirements related to scope of audit;

f) how to plan, conduct, report, and close out audit findings.


Quality Manual

7.3 AwarenessWe ensure that persons doing work under our control are aware of:

a) our quality policy (see 3.2);

b) relevant quality objectives (see 3.3);

c) their contribution to the effectiveness of our QMS, including the benefits of improved performance;

d) the implications of not conforming to our QMS requirements.

7.3.1 Awareness – SupplementalWe maintain documented information to demonstrate that all employees are aware of:

• their impact on product quality and

• the importance of their activities in achieving, maintaining, and improving quality, including customer requirements and risks involved for customer with nonconforming product.

7.3.2 Employee Motivation and EmpowermentWe maintain a documented process to motivate employees to:

• achieve quality objectives,

• make continual improvements, and

• create an environment that promotes innovation.

This process includes the promotion of quality and technological awareness throughout our organization.

7.4 CommunicationWe have determined the internal and external communications relevant to our QMS, including:

a) on what we will communicate;

b) when to communicate;

c) with whom to communicate;

d) how to communicate;

e) who communicates.


Quality Manual

7.5 Documented Information

7.5.1 GeneralOur quality management system includes:

a) documented information required by ISO 9001:2015 and IATF 16949:2016;

b) documented information determined to be necessary for the effectiveness of our QMS.

The extent of our documented information may vary from process to process based on their complexity and the competence of the people that operate or use those processes.

7.5.1.1 Quality Management System DocumentationWe have documented our QMS, including this quality manual, which includes:

a) the scope of QMS, including details of and justification for any exclusions;

b) references to the documented processes established for our QMS;

c) our processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes;

d) a matrix indicating where within our QMS their customer-specific requirements are addressed.

7.5.2 Creating and UpdatingWhen creating and updating documented information, we ensure appropriate:

a) identification and description (e.g., a title, date, author, or reference number);

b) format (e.g., language, software version, graphics) and media (e.g., paper, electronic);

c) review and approval for suitability and adequacy.

7.5.3 Control of Documented Information

7.5.3.1 (untitled)The documented information required by our QMS, and ISO 9001:2015 and IATF 16949:2016, is controlled to ensure it is:

a) available and suitable for use, where and when it is needed;

b) adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 (untitled)For our control of documented information, we have addressed the following activities, as applicable:

a) distribution, access, retrieval, and use;


Quality Manual

b) storage and preservation, including preservation of legibility;

c) control of changes (e.g., version control);

d) retention and disposition.

Documented information of external origin determined as necessary for the planning and operation of our quality management system has been identified as appropriate, and controlled.

Documented information retained as evidence of conformity is protected from unintended alterations.

Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.

7.5.3.2.1 Record RetentionWe have defined, documented, and implemented a record retention policy. Our control of records satisfies statutory, regulatory, organizational, and customer requirements.

We retain production part approvals, tooling records (including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts and amendments. We keep these records for the length of time the product is active for production and service requirements, plus one calendar year, unless otherwise specified by customer or regulatory agency.

Our production part approval documented information may include approved product, applicable test equipment records, or approved test data.

7.5.3.2.2 Engineering SpecificationsWe have documented the process for describing review, distribution, and implementation of all customer engineering specifications and related revisions based on customer schedules, as required.

Refer to 8.3.6 when an engineering specification change results in a product design change. Refer to 8.5.6.1 when an engineering specification change results in a product realization process change. We retain record of the date on which each change was implemented in production. Our implementation includes updated documents.

We strive to complete our engineering change review within 10 working days of receipt. We understand that a change in these specifications may require an updated record of customer production part approval when these specifications are referenced on the design record, or if they affect documents of the production part approval process, such as control plan, risk analysis (such as FMEAs).


Quality Manual

8. Operation

8.1 Operational Planning and ControlWe plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of our products and services, and to implement the actions determined in clause 6, by:

a) determining the requirements for our products and services;

b) establishing criteria for the:

1) processes;

2) acceptance of products and services;

c) determining the resources needed to achieve conformity to our product and service requirements;

d) implementing control of the processes in accordance with the criteria;

e) determining, maintaining, and retaining documented information to the extent necessary to:

1) have confidence that the processes have been carried out as planned;

2) demonstrate the conformity of our products and services to their requirements.

The output of this planning is in a form suitable for our operations. We control planned changes and review the consequences of unintended changes, and act to mitigate any adverse effects, as necessary.

We also ensure that any outsourced processes are controlled (see 8.4).

8.1.1 Operational Planning and Control – SupplementalWe include the following topics when planning for product realization:

a) customer product requirements and technical specifications;

b) logistics requirements;

c) manufacturing feasibility;

d) project planning (refer to 8.3.2);

e) acceptance criteria.

The resources identified in 8.1.c refer to required verification, validation, monitoring, measurement, inspection, and test activities specific to product and criteria for product acceptance.


Quality Manual

8.1.2 ConfidentialityWe ensure confidentiality of customer-contracted products and projects under development, including related product information.

8.2 Requirements for Products and Services

8.2.1 Customer CommunicationCommunication with our customers includes:

a) providing information relating to our products and services;

b) handling inquiries, contracts, or orders, including changes;

c) obtaining customer feedback relating to our products and services, including customer complaints;

d) handling or controlling any customer property;

e) establishing specific requirements for contingency actions, when relevant.

8.2.1.1 Customer Communication – SupplementalOur written or verbal communication is in the language agreed with the customer. We can communicate the necessary information, including data in a customer-specified computer language and format (e.g., computer-aided design data, electronic data exchange).

8.2.2 Determining the Requirements for Products and ServicesWhen determining the requirements for the products and services to be offered to customers, we ensure that:

a) the requirements for our products and services are defined, including:

1) any applicable legal (statutory and regulatory) requirements;

2) those considered necessary by our organization;

b) we can meet the claims for our products and services.

8.2.2.1 Determining the Requirements for Products and Services - SupplementalThe requirements for our products and services include the recycling, environmental impact, and characteristics identified as result of our knowledge of product and manufacturing processes.

Compliance to 8.2.2.a.1 includes, but is not limited to all applicable government, safety, and environmental regulations related to acquisition, storage, handling, recycling, elimination, or disposal of material.


Quality Manual

8.2.3 Review of the Requirements for Products and Services

8.2.3.1 (untitled)We ensure that we can meet the requirements for our products and services to be offered to customers. We conduct a review before committing to supply products and services to a customer that includes:

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;

b) requirements not stated by the customer, but necessary for the specified or intended use, when known;

c) requirements specified by our organization;

d) statutory and regulatory requirements applicable to our products and services;

e) contract or order requirements differing from those previously expressed.

We ensure that contract or order requirements differing from those previously defined are resolved. We confirm the customer’s requirements before acceptance, when the customer does not provide a documented statement of their requirements.

In some situations, such as internet sales, a formal review is impractical for each order. Instead, our review would cover the relevant product information used during the automated process.

8.2.3.1.1 Review of the Requirements for Products and Services - SupplementalWe retain documented evidence of a customer-authorized waiver for the requirements stated in 8.2.3.1 for a formal review.

8.2.3.1.2 Customer-Designated Special CharacteristicsWe conform to customer requirements for designation, approval documentation, and control of special characteristics.

8.2.3.1.3 Organization Manufacturing FeasibilityWe use a multidisciplinary approach to conduct an analysis to determine if it is feasible that manufacturing processes are capable of consistently producing product that meets all engineering and capacity requirements specified by the customer.

We conduct this feasibility analysis for any manufacturing or product technology new to our organization and for any changed manufacturing process or product design.

We validate our ability to make product to specification at the required rate through:

• production runs, • benchmark studies, or • other appropriate methods.


Quality Manual

8.2.3.2 (untitled)We retain documented information (records), as applicable, on:

a) the results of the review;

b) any new requirements for the products and services.

8.2.4 Changes to Requirements for Products and ServicesWe ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for our products and services are changed.

8.3 Design and Development of Products and Services

8.3.1 GeneralWe have established, implemented, and maintain a design and development process that is appropriate to ensure the subsequent provision of our products and services.

8.3.1.1 Design and Development of Products and Services – SupplementalWe apply the requirements of 8.3.1 to product and manufacturing process design and development and focus on error prevention rather than detection. We use a documented design and development process.

8.3.2 Design and Development PlanningIn determining the stages and controls for design and development, we consider the:

a) nature, duration, and complexity of the design and development activities;

b) required process stages, including applicable design and development reviews;

c) required design and development verification and validation activities;

d) responsibilities and authorities involved in the design and development process;

e) internal and external resource needs for the design and development of our products and services;

f) need to control interfaces between persons involved in the design and development process;

g) need for involvement of customers and users in the design and development process;

h) requirements for subsequent provision of our products and services;

i) level of control expected for the design and development process by our customers and other relevant interested parties;

j) documented information needed to demonstrate that design and development requirements have been met.


Quality Manual

8.3.2.1 Design and Development Planning – SupplementalWe ensure that the design and development planning includes all affected stakeholders within our organization and its supply chain. Examples of areas for using a multidisciplinary approach include but are not limited to:

a) project management (e.g., APQP);

b) product and manufacturing process design activities (e.g., DFM and DFA) such as consideration of the use of alternative designs and manufacturing processes;

c) development and review of product design risk analysis (FMEAs), including actions to reduce potential risks;

d) development and review of manufacturing process risk analysis (e.g., FMEAs, process flows, control plans, standard work instructions).

Our multidisciplinary approach typically includes design, manufacturing, engineering, quality, production, purchasing, supplier, maintenance, and other appropriate functions.

8.3.2.2 Product Design SkillsWe ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in the applicable product design tools and techniques (which we have identified).

8.3.2.3 Development of Products with Embedded SoftwareWe use a process for quality assurance for our products with internally developed embedded software. A software development assessment methodology is used to assess our software development process.

Using prioritization based on risk and potential impact to the customer, we retain documented information of a software development capability self-assessment.

8.3.3 Design and Development InputsWe determine the requirements essential for the specific types of products and services to be designed and developed. We consider:

a) functional and performance requirements;

b) information derived from previous similar design and development activities;

c) legal (statutory and regulatory) requirements;

d) standards or codes of practice that we have committed to implement;

e) potential consequences of failure due to the nature of our products and services.


Quality Manual

The inputs will be adequate for design and development purposes, complete, and unambiguous. Any conflicting design and development inputs will be resolved.

We retain documented information (records) on the design and development inputs.

8.3.3.1 Product Design InputWe identify, document, and review product design input requirements as result of contract review. Product design input requirements include, but are not limited to:

a) product specifications, including but not limited to special characteristics (see 8.3.3.3);

b) boundary and interface requirements;

c) identification, traceability, and packaging;

d) consideration of design alternatives;

e) assessment of risks within the input requirements and our ability to mitigate/manage the risks, including from the feasibility analysis;

f) targets for conformity to product requirements including preservation, reliability, durability, serviceability, health, safety, environmental, development timing, and cost;

g) applicable statutory and regulatory requirements of customer-identified country of destination, if provided;

h) embedded software requirements.

We have a process to deploy information gained from previous design projects, competitive product analysis (benchmarking), supplier feedback, internal input, field data, and other relevant sources for current and future projects of a similar nature.

8.3.3.2 Manufacturing Process Design InputWe identify, document, and review manufacturing process design input requirements including, but not limited to:

a) product design output data including special characteristics;

b) targets for productivity, process capability, timing, and cost;

c) manufacturing technology alternatives;

d) customer requirements, if any;

e) experience from previous developments;

f) new materials;


Quality Manual

g) product handling and ergonomic requirements;

h) design for manufacturing and design for assembly.

Our manufacturing process design includes the use of error-proofing methods to a degree appropriate to magnitude of problems and commensurate with risks encountered.

8.3.3.3 Special CharacteristicsWe use a multidisciplinary approach to establish, document, and implement our processes to identify special characteristics, including those determined by the customer and our risk analysis, and include:

a) documentation of all special characteristics in drawings (as required), risk analysis (e.g., FMEA), control plans, and standard work/operator instructions; special characteristics are identified with special markings and are cascaded through each of these documents;

b) development of control and monitoring strategies for special characteristics of products and production processes;

c) customer-specified approvals, when required;

d) compliance with customer-specified definitions and symbols, or our equivalent symbols or notations, as defined in a symbol conversion table. We will submit the symbol conversion table to the customer, if required.

8.3.4 Design and Development ControlsWe have applied controls to the design and development process to ensure that:

a) the results to be achieved are defined;

b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;

c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;

d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;

e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;

f) documented information (records) of these activities is retained.

Design and development reviews, verification, and validation have distinct purposes. They may be conducted separately, or in any combination, as is suitable for our products and services.


Quality Manual

8.3.4.1 MonitoringWe define, analyze, and report measurements (at specified stages during design and development) with summary results as an input to management review (see 9.3.2.1).

We report measurements of the product and process development activity to the customer at stages specified, or agreed to, by the customer. When appropriate, these measurements may include quality risks, costs, lead times, critical paths, and other measurements.

8.3.4.2 Design and Development ValidationWe perform design and development validation in accordance with customer requirements, including any applicable industry and government agency-issued regulatory standards. We plan the timing of design and development validation in alignment with customer-specified timing, as applicable.

Where contractually agreed with the customer, we include evaluation of interaction of our product, including embedded software, within system of the final customer’s product.

8.3.4.3 Prototype ProgramWhen required by the customer, we will have a prototype program and control plan. We will use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in production.

We monitor all performance-testing activities for timely completion and conformity to requirements.

When services are outsourced, we include the type and extent of control in the scope of our QMS to ensure outsourced services meet requirements (see 8.4).

8.3.4.4 Product Approval ProcessWe have established, implemented, and maintain a product and manufacturing approval process conforming to requirements defined by customers.

We approve externally provided products and services per 8.4.3 prior to submission of part approval to customer. We obtain documented product approval prior to shipment, if required by the customer, and retain approval records.

Product approval occurs after verification of our manufacturing process.

8.3.5 Design and Development OutputsWe ensure that design and development outputs:

a) meet the input requirements;

b) are adequate for the subsequent processes for the provision of our products and services;

c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;

d) specify the characteristics of our products and services that are essential for their intended


Quality Manual

purpose and their safe and proper provision.

We retain documented information (records) on design and development outputs.

8.3.5.1 Design and Development Outputs – SupplementalWe express the product design output in terms that can be verified and validated against product design input requirements. The output includes, but is not limited to:

a) design risk analysis (FMEA);

b) reliability study results;

c) product special characteristics;

d) results of product design error-proofing, such as DFSS, DFMA, and FTA;

e) product definition including 3D models, technical data packages, product manufacturing information, and geometric dimensioning and tolerancing (GD&T);

f) 2D drawings, product manufacturing information, and geometric dimensioning and tolerancing (GD&T);

g) product design review results;

h) service diagnostic guidelines and repair and serviceability instructions;

i) service part requirements;

j) packaging and labeling requirements for shipping.

Interim design outputs include any engineering problems being resolved through a trade-off process.

8.3.5.2 Manufacturing Process Design OutputWe document our manufacturing process design output in a manner that enables verification against the manufacturing process design inputs. We verify the outputs against manufacturing process design input requirements..Our manufacturing process design output includes, but is not limited to:

a) specifications and drawings;

b) special characteristics for product and manufacturing process;

c) identification of process input variables that impact characteristics;


Quality Manual

d) tooling and equipment for production and control, including capability studies of equipment and processes;

e) manufacturing process flow charts/layout, including linkage of product, process, and tooling;

f) capacity analysis;

g) manufacturing process FMEA;

h) maintenance plans and instructions;

i) control plan;

j) standard work and work instructions;

k) process approval acceptance criteria;

l) data for quality, reliability, maintainability, and measurability;

m) results of error-proofing identification and verification, as appropriate;

n) methods of rapid detection, feedback, and correction of product and manufacturing nonconformities.

8.3.6 Design and Development ChangesWe identify, review, and control any changes made during or after the design and development of our products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

We retain documented information (records) on the:

a) design and development changes;

b) results of reviews;

c) authorization of the changes;

d) actions taken to prevent adverse impacts.

8.3.6.1 Design and Development ChangesWe evaluate all design changes after initial product approval, including those proposed by us or our suppliers, for potential impact on fit, form, function, performance, and/or durability. We validate these changes against customer requirements and approve them internally prior to implementing production.


Quality Manual

If required by the customer, we obtain documented approval, or documented waiver, from the customer prior to production implementation

For products with embedded software, we document the revision level of software and hardware as part of the change record.

8.4 Control of Externally Provided Processes, Products, and Services

8.4.1 GeneralWe ensure that externally provided processes, products, and services conform to requirements.

We determine the controls to be applied to externally provided processes, products, and services when:

a) products and services from external providers are intended for incorporation into our own products and services;

b) products and services are provided directly to our customers by external providers on our behalf;

c) a process, or part of a process, is provided by an external provider because of a decision by us.

We determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. We retain documented information (records) of these activities and any necessary actions arising from the evaluations.

8.4.1.1 General - SupplementalWe include all products and services that affect customer requirements (e.g., subassembly, sequencing, sorting, rework, and calibration services) in the scope of our defined externally provided products, processes, and services.

8.4.1.2 Supplier Selection ProcessWe use a documented supplier selection process that includes:

a) assessment of the selected supplier’s risk to product conformity and uninterrupted supply of our product to customers;

b) relevant quality and delivery performance;

c) evaluation of the supplier’s QMS;

d) multidisciplinary decision making; and

e) an assessment of software development capabilities, if applicable.

We also consider other supplier selection criteria:

• volume of automotive business (absolute and as percentage of total business);• financial stability;


Quality Manual

• purchased product, material, or service complexity;• required technology (product or process);• adequacy of available resources (e.g., people, infrastructure); • design and development capabilities (including project management);• manufacturing capability;• change management process;• business continuity planning (e.g., disaster preparedness, contingency planning);• logistics process;• customer service.

8.4.1.3 Customer-Directed SourcesWe purchase products, materials, or services from customer-directed sources, also known as “directed-buy”, when specified.

We apply all the 8.4 requirements (except for 8.4.1.2) to the control of customer-directed sources, unless specific agreements are otherwise defined by contract with the customer.

8.4.2 Type and Extent of ControlWe ensure that externally provided processes, products, and services do not adversely affect our ability to consistently deliver conforming products and services to our customers.

Our organization:

a) ensures that externally provided processes remain within the control of our QMS;

b) defines both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;

c) takes into consideration the:

1) potential impact of the externally provided processes, products, and services on our ability to consistently meet customer and applicable legal (statutory and regulatory) requirements;

2) effectiveness of the controls applied by the external provider;

d) determines the verification, or other activities, necessary to ensure that the externally provided processes, products, and services meet requirements.

8.4.2.1 Type and Extent of Control - SupplementalWe use a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provide products, processes, and services to internal (organizational) and external customer requirements.

The process includes the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks.


Quality Manual

8.4.2.2 Statutory and Regulatory RequirementsWe use a documented process to ensure that purchased products, processes, and services conform to the current applicable statutory and regulatory requirements in the country of receipt, country of shipment, and customer-identified country of destination, if provided.

If the customer defines special controls for certain products with statutory and regulatory requirements, we ensure they are implemented and maintained as defined, including at suppliers.

8.4.2.3 Supplier Quality Management System DevelopmentWe require our suppliers of automotive products and services to develop, implement, and improve a QMS certified to ISO 9001, unless otherwise authorized by the customer [e.g., see item a) below], with the ultimate objective of IATF 16949 certification.

Unless otherwise specified by the customer, we apply the following sequence to achieve this requirement:

a) compliance to ISO 9001 through second-party audits;

b) certification to ISO 9001 by third-party audits;

Unless otherwise specified by the customer, our suppliers must demonstrate conformity to ISO 9001 by maintaining a third-party certification issued by a certification body bearing the accreditation mark of a recognized IAF MLA member and where the accreditation body’s main scope includes management system certification to ISO 17021;

c) certification to ISO 9001 with compliance to other customer-defined QMS requirements through second-party audits;

d) certification to ISO 9001 with compliance to IATF 16949 through second-party audits;

e) certification to IATF 16949 through third-party audits by an IATF-recognized certification body.

8.4.2.3.1 Automotive Product-Related Software or Automotive Products with Embedded SoftwareWe require suppliers of automotive product-related software, or automotive products with embedded software, to implement and maintain a process for software quality assurance for their products.

We use a software development assessment methodology to assess the supplier’s software development process. Using prioritization based on risk and potential impact to the customer, we require the supplier to retain documented information of a software development capability self-assessment.

8.4.2.4 Supplier MonitoringWe use a documented process and criteria to evaluate supplier performance to ensure conformity of externally provided products, processes, and services to internal and external customer requirements.

We monitor the following supplier performance indicators:

a) delivered product conformity to requirements;


Quality Manual

b) customer disruptions at receiving plant, including yard holds and stop ships;

c) delivery schedule performance;

d) number of occurrences of premium freight.

If provided by customer, we also include, as appropriate, in supplier performance monitoring:

e) special status customer notifications related to quality or delivery issues;

f) dealer returns, warranty, field actions, and recalls.

8.4.2.4.1 Second-Party AuditsWe include a second-party audit process in our supplier management approach. We may use second-party audits for:

a) supplier risk assessments;

b) supplier monitoring;

c) supplier QMS development;

d) product audits;

e) process audits.

Based on a risk analysis, including product safety/regulatory requirements, performance of supplier, and QMS certification level, we document the criteria for determining need, type, frequency, and scope of second-party audits. We retain records of second-party audit reports.

If the scope of the second-party audit is to assess the supplier’s QMS, then the approach must be consistent with the automotive process approach.

We rely upon the guidance in IATF Auditor Guide and ISO 19011.

8.4.2.5 Supplier DevelopmentWe determine the priority, type, extent, and timing of required supplier development actions for our active suppliers, and include these inputs:

a) performance issues identified through supplier monitoring (see 8.4.2.4);

b) second-party audit findings (see 8.4.2.4.1);

c) third-party QMS certification status;

d) risk analysis.


Quality Manual

We implement the actions necessary to resolve open (unsatisfactory) performance issues and pursue opportunities for continual improvement.

8.4.3 Information for External ProvidersWe ensure the adequacy of requirements prior to their communication to the external provider. We communicate to external providers our requirements for:

a) the processes, products and services to be provided;

b) the approval of:

1) products and services;

2) methods, processes, and equipment;

3) the release of products and services;

c) competence, including any required qualification of persons;

d) the external providers’ interactions with us;

e) control and monitoring of the external providers’ performance to be applied by us;

f) verification or validation activities that we, or our customer, intends to perform at the external providers’ premises.

8.4.3.1 Information for External Providers – SupplementalWe pass down all applicable statutory and regulatory requirements and special product and process characteristics to our suppliers. We require our suppliers to cascade all applicable requirements down the supply chain to the point of manufacture.

8.5 Production and Service Provision

8.5.1 Control of Production and Service ProvisionWe implement production and service provision under controlled conditions. Those controlled conditions include, as applicable, the:

a) availability of documented information that defines the:

1) characteristics of the products to be produced, the services to be provided, or the activities to be performed;

2) results to be achieved;

b) availability and use of suitable monitoring and measuring resources;

c) implementation of monitoring and measurement activities at appropriate stages to verify that


Quality Manual

criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;

d) use of suitable infrastructure and environment for the operation of processes;

e) appointment of competent persons, including any required qualification;

f) validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;

g) implementation of actions to prevent human error;

h) implementation of release, delivery, and post-delivery activities.

8.5.1.1 Control PlanWe develop control plans (in accordance with Annex A of IATF 16949:2016) at the system, subsystem, component, and/or material level for the relevant manufacturing site and all product supplied, including those for processes producing bulk materials as well as parts.

We understand that family control plans are acceptable for bulk material and similar parts using a common manufacturing process.

We have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis (if provided by customer), process flow diagram, and manufacturing process risk analysis outputs (such as FMEA).

If required by customer, we provide measurement and conformity data collected during execution of either the pre-launch or production control plans.

We include in control plan:

a) controls used for manufacturing process control, including verification of job set-ups;

b) first-off/last-off part validation, as applicable;

c) methods for monitoring of control exercised over special characteristics defined by both the customer and our organization;

d) customer-specified information, if any;

e) specified reaction plan when nonconforming product is detected, the process becomes statistically unstable, or not statistically capable.

We review the control plans, and update them as required, for any of the following:

f) our organization determines we have shipped nonconforming product to the customer;


Quality Manual

g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA);

h) after customer complaint and implementation of associated corrective action, when applicable;

i) at a set frequency based on risk analysis.

If required by the customer, we obtain customer approval after review or revision of control plan.

8.5.1.2 Standardized Work – Operator Instructions and Visual StandardsWe ensure that standardized work documents are:

a) communicated to and understood by the employees responsible for the performing work;

b) legible;

c) presented in the language understood by the personnel responsible to follow them;

d) accessible for use at the designated work areas.

Our standardized work documents include rules for operator safety.

8.5.1.3 Verification of Job Set-upsOur organization will:

a) verify job set-ups when performed, such as initial run of job, material changeover, or job change that requires a new set-up;

b) maintain documented information for set-up personnel;

c) use statistical methods of verification, where applicable;

d) perform first-off/last-off part validation, as applicable; where appropriate:

first-off parts are retained for comparison with last-off parts; last-off parts are retained for comparison with first-off parts in subsequent runs;

e) retain records of process and product approval following set-up and first-off/last-off part validations.

8.5.1.4 Verification After ShutdownWe define and implement the necessary actions to ensure product compliance with requirements after a planned or unplanned production shutdown period.

8.5.1.5 Total Productive MaintenanceWe have developed, implemented, and maintain a documented total productive maintenance system.Our system includes:


Quality Manual

a) identification of process equipment necessary to produce conforming product at required volume;

b) availability of replacement parts for the equipment identified in entry a) above;

c) provision of resource for machine, equipment, and facility maintenance;

d) packaging and preservation of equipment, tooling, and gauging;

e) applicable customer-specific requirements;

f) documented maintenance objectives, e.g.,

OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure), MTTR (Mean Tie to Repair), and Preventive Maintenance compliance metrics.

Performance to the maintenance objectives is an input to management reviews (see 9.3);

g) regular review of maintenance plan and objectives, and a documented action plan to address corrective actions where objectives are not achieved;

h) use of preventive maintenance methods;

i) use of predictive maintenance methods, as applicable;

j) periodic overhaul.

8.5.1.6 Management of Production Tooling and Manufacturing, Test, Inspection Tooling and Equipment We provide resources for tool and gauge design, fabrication, and verification activities for production and service materials and for bulk materials, as applicable.

We have established and implemented a system for production tooling management, whether owned by us or the customer, including:

a) maintenance and repair facilities and personnel;

b) storage and recovery;

c) set-up;

d) tool-change programs for perishable tools;

e) tool design modification documentation, including engineering change level of the product;

f) tool modification and revision to documentation;


Quality Manual

g) tool identification, such as serial or asset number; the status, such as production, repair, or disposal; ownership; and location.

We verify that customer-owned tools, manufacturing equipment, and test/inspection equipment are permanently marked in a visible location so that the ownership and application of each item can be determined. We’ve implemented a system to monitor these activities, if any work is outsourced.

8.5.1.7 Production SchedulingWe ensure that production is scheduled to meet customer orders/demands such as Just-In-Time (JIT) and is supported by an information system that permits access to production information at key stages of the process and is order driven.

We include relevant planning information during production scheduling, e.g., customer orders, supplier on-time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, preventive maintenance, and calibration.

8.5.2 Identification and TraceabilityWe use suitable means to identify outputs when it is necessary to ensure the conformity of products and services. We identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

We control the unique identification of the outputs when traceability is a requirement, and retain the documented information (records) necessary to enable traceability.

We understand that inspection and test status is not indicated by the location of the product in the production flow, unless inherently obvious, such as material in an automated production transfer process. Alternatives are permitted if the status is clearly identified, documented, and achieves the designated purpose.

8.5.2.1 Identification and Traceability – SupplementalThe purpose of traceability is to support identification of clear start and stop points for product received by the customer or in the field that may contain quality and/or safety-related nonconformities.

We have implemented identification and traceability processes as described below.

We conduct an analysis of internal, customer, and regulatory traceability requirements for all automotive products, including developing and documenting traceability plans, based on levels of risk or failure severity for employees, customers, and consumers.

These plans define the appropriate traceability systems, processes, and methods by product, process, and manufacturing location to:

a) enable identification of nonconforming and/or suspect product;

b) enable segregation of nonconforming and/or suspect product;


Quality Manual

c) ensure the ability to meet customer and/or regulatory response time requirements;

d) ensure documented information is retained in the format (electronic, hardcopy, archive) that enables us to meet the response time requirements;

e) ensure serialized identification of individual products, if specified by the customer or regulatory standards;

f) ensure the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics.

8.5.3 Property belonging to Customers or External providersWe exercise care with property belonging to customers or external providers while it is under our control or being used by us.

We identify, verify, protect, and safeguard customers’ or external providers’ property provided for use or incorporation into our products and services.

When the property of a customer or external provider is lost, damaged, or otherwise found to be unsuitable for use, we report this to the customer or external provider and retain documented information (records) on what has occurred.

The property of our customers and external providers may include materials, components, tools and equipment, premises, intellectual property, and personal data.

8.5.4 PreservationWe preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.

Preservation may include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.

8.5.4.1 Preservation – SupplementalPreservation includes identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. Preservation is applied to materials and components from external and/or internal providers from receipt through processing, including shipment and until delivery to, or acceptance by, the customer.

To detect deterioration, we assess at appropriate planned intervals the condition of product in stock, the place or type of storage container, and the storage environment.

We use an inventory management system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out” (FIFO).

We ensure that obsolete product is controlled in a manner like that of nonconforming product. We comply with preservation, packaging, shipping, and labeling requirements as provided by customers.


Quality Manual

8.5.5 Post-delivery activitiesWe meet the requirements for post-delivery activities associated with our products and services.

In determining the extent of required post-delivery activities, we consider:

a) legal (statutory and regulatory) requirements;

b) the potential undesired consequences associated with our products and services;

c) the nature, use, and intended lifetime of our products and services;

d) customer requirements;

e) customer feedback.

Post-delivery activities may include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

8.5.5.1 Feedback of Information from ServiceWe ensure that a process for communication of information on service concerns to manufacturing, material handling, logistics, engineering, and design activities is established, implemented, and maintained.

Nonconforming products and materials may be identified at the customer location or in the field.Service concerns may include the results of field failure test analysis (see 10.2.6), where applicable.

8.5.5.2 Service Agreement with CustomerWhen there is a service agreement with the customer, we:

a) verify that the relevant service centers comply with applicable requirements;

b) verify the effectiveness of any special purpose tools or measurement equipment;

c) ensure that all service personnel are trained in applicable requirements.

8.5.6 Control of changesWe review and control changes for production and service provision (to the extent necessary to ensure continuing conformity with requirements).

We retain documented information (records) describing the results of the review of changes, the persons authorizing the change, and any necessary actions arising from the review.

8.5.6.1 Control of Changes – SupplementalWe use a documented process to control and react to changes that impact product realization. The effects of any change, including changes caused by our organization, customer, or suppliers, is assessed.


Quality Manual


Quality Manual

As an organization, we:

a) define verification and validation activities to ensure compliance to customer requirements;

b) validate changes before implementation;

c) document evidence of related risk analysis;

d) retain records of verification and validation.

Changes, including those made at suppliers, require a production trial run for verification of changes (e.g., changes to part design, manufacturing site, or manufacturing process) to validate the impact of any changes on the manufacturing process.

When required by the customer, we:

e) notify the customer of any planned product realization changes after the most recent product approval;

f) obtain documented approval, prior to implementation of the change;

g) complete additional verification or identification requirements, e.g., production trial run and new product validation.

8.5.6.1.1 Temporary Change of Process ControlsWe have Identified, documented, and maintain a list of process controls, including inspection, measuring, test, and error-proofing devices, that includes the primary process control and the approved back-up or alternate methods.

We use a documented process to manage the use of alternate control methods. We have included in this process, based on risk analysis (such as FMEA), severity, and the internal approvals to be obtained prior to production implementation of the alternate control method.

Before shipping product that was inspected or tested using the alternate method, if required, obtain approval from the customer.

We maintain and periodically review a list of approved alternate process control methods that are referenced in the control plan.

We make standardized work instructions available for each alternate process control method. We review the operation of alternate process controls on daily basis, at a minimum, to verify implementation of standard work with goal to return to the standard process as defined by control plan as soon as possible.

Example methods include, but are not limited to:

a) daily quality focused audits (e.g., layered process audits, as applicable);

b) daily leadership meetings.


Quality Manual

We document the restart verification for a defined period based on severity and confirmation that all features of error-proofing device or process are effectively reinstated.

We implement traceability of all product produced while any alternative process control devices or processes are being used (e.g., verification and retention of first piece and last piece from every shift).

8.6 Release of Products and ServicesWe implement planned arrangements, at appropriate stages, to verify that our product and service requirements have been met.

The release of products and services to the customer does not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.

We retain documented information (records) on the release of products and services. The documented information includes:

a) evidence of conformity with the acceptance criteria;

b) traceability to the persons authorizing the release.

8.6.1 Release of Products and Services - SupplementalWe ensure that the planned arrangements to verify that the product and service requirements have been met encompass the control plan and are documented as specified in the control plan.

We ensure that planned arrangements for initial release of products and services encompass product or service approval. We also ensure that product or service approval is accomplished after changes following initial release, according to 8.5.6.

8.6.2 Layout Inspection and Functional TestingWe perform a layout inspection and a functional verification to applicable customer engineering material and performance standards for each product as specified in the control plans. The results are available for customer review. Our layout inspection is a complete measurement of all product dimensions shown on the design records. The frequency of layout inspection is determined by the customer.

8.6.3 Appearance ItemsFor manufactured parts designated by the customer as “appearance items”, we provide:

a) appropriate resources, including lighting, for evaluation;

b) masters for color, grain, gloss, metallic brilliance, texture, distinctness of image, and haptic technology, as appropriate;

c) maintenance and control of appearance masters and evaluation equipment;

d) verification that personnel making appearance evaluations are competent and qualified.


Quality Manual

8.6.4 Verification and Acceptance of Conformity of Externally Provided Products and ServicesWe have a process to ensure the quality of externally provided processes, products, and services using one or more of these methods:

a) receipt and evaluation of statistical data provided by the supplier;

b) receiving inspection and/or testing, such as sampling based on performance;

c) second-party or third-party assessments or audits of supplier sites when coupled with records of acceptable delivered product conformance to requirements;

d) part evaluation by designated laboratory;

e) another method agreed with the customer.

8.6.5 Statutory and Regulatory ConformityPrior to release of externally provided products into the production flow, we confirm we can provide evidence that externally provided processes, products, and services conform to the latest applicable statutory, regulatory, and other requirements in countries where they are manufactured and in the customer-identified countries of destination, if provided.

8.6.6 Acceptance CriteriaWe define acceptance criteria and, where appropriate or required, have the criteria approved by the customer. For attribute data sampling, we set the acceptance level as zero defects (see 9.1.1.1).

8.7 Control of Nonconforming Outputs

8.7.1 (untitled)We ensure that outputs that do not conform to our requirements are identified and controlled to prevent their unintended use or delivery.

We take the appropriate action based on the nature of the nonconformity and its effect on the conformity of our products and services. This also applies to nonconforming products and services detected after delivery of products, and during or after the provision of services.

We deal with nonconforming outputs in one or more of the following ways:

a) correction;

b) segregation, containment, return, or suspension of provision of products and services;

c) informing the customer;

d) obtaining authorization for acceptance under concession.

Conformity to the requirements is verified when nonconforming outputs are corrected.


Quality Manual

8.7.1.1 Customer Authorization for ConcessionWe obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.

We obtain customer authorization prior to further processing for “use as is” and rework dispositions of nonconforming product. If sub-components are reused in the manufacturing process, we clearly communicate this reuse to the customer in the concession or deviation permit. We maintain a record of the expiration date or quantity authorized under concession. We also ensure compliance with the original or superseding specifications and requirements when the authorization expires.

We properly identify on each shipping container the materials shipped under concession (this applies equally to purchased product). We approve any requests from suppliers before submission to the customer.

8.7.1.2 Control of Nonconforming Product – Customer-Specified ProcessWe comply with applicable customer-specified controls for nonconforming products.

8.7.1.3 Control of Suspect ProductWe ensure that product with unidentified or suspect status is classified and controlled as nonconforming product. We ensure that all appropriate manufacturing personnel receive training for containment of suspect and nonconforming product.

8.7.1.4 Control of Reworked ProductWe use risk analysis (such as FMEA) methodology to assess risks in the rework process prior to a decision to rework the product. If required by customer, we obtain approval from the customer prior to commencing rework of the product.

We follow a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications.

We ensure that instructions for disassembly or rework, including re-inspection and traceability requirements, are accessible to and used by the appropriate personnel.

We retain documented information on the disposition of reworked product, including quantity, disposition, disposition date, and applicable traceability information.

8.7.1.5 Control of Repaired ProductWe use risk analysis (such as FMEA) methodology to assess risks in the repair process prior to a decision to repair the product. We obtain approval from the customer before commencing repair of the product.

We follow a documented process for repair confirmation in accordance with the control plan or other relevant documented information. We ensure that instructions for disassembly or repair, including re-inspection and traceability requirements, are accessible to and used by the appropriate personnel.


Quality Manual

We obtain a documented customer authorization for concession for the product to be repaired.

We retain documented information on the disposition of repaired product, including quantity, disposition, disposition date, and applicable traceability information.

8.7.1.6 Customer NotificationWe immediately notify our customers if nonconforming product has been shipped. We follow the initial communication with detailed documentation of the event.

8.7.1.7 Nonconformity Product DispositionWe use a documented process for disposition of nonconforming product not subject to rework or repair.For product not meeting requirements, we verify that the product to be scrapped is rendered unusable prior to disposal.

We do not divert nonconforming product to service or other use without prior customer approval .

8.7.2 (untitled)We retain documented information (records) that:

a) describes the nonconformity;

b) describes the actions taken;

c) describes any concessions obtained;

d) identifies the authority deciding the action in respect of the nonconformity.

9. Performance Evaluation

9.1 Monitoring, Measurement, Analysis, and Evaluation

9.1.1 GeneralWe determine:

a) what needs to be monitored and measured;

b) methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results;

c) when the monitoring and measuring must be performed;

d) when the results from monitoring and measurement must be analyzed and evaluated.

We evaluate the performance and the effectiveness of our quality management system. We retain appropriate documented information (records) as evidence of the results.


Quality Manual

9.1.1.1 Monitoring and Measurement of Manufacturing ProcessesWe perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control, including those for special characteristics.

For some of our manufacturing processes, it may not be possible to demonstrate product compliance through process capability. For those processes, we may use alternate methods such as batch conformance to specification.

We maintain manufacturing process capability or performance results as specified by the customer’s part approval process requirements. We verify that the process flow diagram, PFMEA, and control plan are implemented, including adherence to:

a) measurement techniques;

b) sampling plans;

c) acceptance criteria;

d) records of actual measurement values and/or test results for variable data;

e) reaction plans and escalation process when acceptance criteria are not met.

We record and retain as documented information any significant process events, such as tool change or machine repair.

We initiate a reaction plan indicated on the control plan and evaluate for impact on compliance to specification for characteristics that are either not statistically capable or are unstable. These reaction plans include product containment and 100 percent inspection, as appropriate. We develop and implement a corrective action plan indicating specific actions, timing, and assigned responsibilities to ensure that the process becomes stable and statistically capable. The plans are reviewed with, and have approved by, the customer, when required.

We maintain records of the effective dates of process changes.

9.1.1.2 Identification of Statistical ToolsWe determine the appropriate use of statistical tools. We verify that appropriate statistical tools are included as part of advanced product quality planning (or equivalent) process and included in the design risk analysis (such as DFMEA), the process risk analysis (such as PFMEA), and the control plan.

9.1.1.3 Application of Statistical ConceptsStatistical concepts, such as variation, control (stability), process capability, and the consequences of over-adjustment are understood and used by employees involved in the collection, analysis, and management of statistical data.


Quality Manual

9.1.2 Customer SatisfactionWe monitor our customers’ perceptions of the degree to which their needs and expectations have been fulfilled. We have determined the methods for obtaining, monitoring, and reviewing this information.

Examples of monitoring customer perceptions may include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims, and dealer reports.

9.1.2.1 Customer Satisfaction – SupplementalWe monitor customer satisfaction through continual evaluation of internal and external performance indicators to ensure compliance to product and process specifications and other customer requirements.

We base performance indicators on objective evidence that includes, but is not limited to:

a) delivered part quality performance;

b) customer disruptions;

c) field returns, recalls, and warranty (where applicable)

d) delivery schedule performance (including incidents of premium freight);

e) customer notifications related to quality or delivery issues, including special status;

We monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency. The monitoring includes the review of customer performance data, including online customer portals and customer scorecards, where provided.

9.1.3 Analysis and EvaluationWe analyze and evaluate appropriate data and information arising from monitoring and measurement. The results of analysis are used to evaluate:

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of our quality management system;

d) if planning has been implemented effectively;

e) the effectiveness of actions taken to address risks and opportunities;

f) the performance of external providers;

g) the need for improvements to the quality management system.

Methods to analyze the data may include statistical techniques.


Quality Manual

9.1.3.1 PrioritizationWe compare trends in quality and operational performance with progress toward objectives and lead to action to support prioritization of actions for improving customer satisfaction.

9.2 Internal Audit

9.2.1 (untitled)We conduct internal audits at planned intervals to provide information on whether our quality management system:

a) conforms to:

1) our requirements for our quality management system;

2) the requirements of ISO 9001:2015 and IATF 16949:2016;

b) is effectively implemented and maintained.

9.2.2 (untitled)Our organization:

a) plans, establishes, implements, and maintains an audit program including the frequency, methods, responsibilities, planning requirements, and reporting, which take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;

b) defines the audit criteria and scope for each audit;

c) selects auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

d) ensures that the results of the audits are reported to relevant management;

e) takes appropriate correction and corrective actions without undue delay;

f) retains documented information (records) as evidence of the implementation of the audit program and the audit results.

9.2.2.1 Internal Audit ProgramWe have a documented internal audit process. The process includes the development and implementation of an internal audit program that covers the entire QMS, including QMS audits, manufacturing process audits, and product audits.

We prioritize the audit program based on risk, internal and external performance trends, and criticality of the processes. We include software development capability assessments in the internal audit program (if responsible for software development).

We review the frequency of audits and, where appropriate, adjust the frequency based on occurrence of process changes, internal and external nonconformities, and/or customer complaints.


Quality Manual

We also review the effectiveness of the audit program as a part of management review.

9.2.2.2 Quality Management System AuditWe audit all QMS processes over each three-year calendar period, according to an annual program, using the process approach to verify compliance with IATF 16949:2016..Integrated with these audits, we sample customer-specific QMS requirements for effective implementation.

9.2.2.3 Manufacturing Process AuditWe audit all manufacturing processes over each three-year calendar period to determine their effectiveness and efficiency using customer-specific required approaches for process audits. If not defined by the customer, we determine the approach to be used.

Within each individual audit plan, we audit each manufacturing process on all shifts where it occurs, including the appropriate sampling of shift handover. We include an audit of the effective implementation of process risk analysis (such as PFMEA), control plan, and associated documents.

9.2.2.4 Product AuditWe audit our products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specific requirements. If not defined by the customer, we define the approach to be used.

9.3 Management Review

9.3.1 GeneralTop management reviews our quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with our strategic direction.

9.3.1.1 Management Review – SupplementalWe conduct management reviews at least annually. The frequency of management reviews may be increased based on the risk to compliance with customer requirements resulting from internal or external changes impacting the QMS and performance-related issues.

9.3.2 Management Review InputsOur management reviews are planned and carried out taking into consideration:

a) the status of actions from previous management reviews;

b) changes in external and internal issues that are relevant to our quality management system;

c) information on the performance and effectiveness of our QMS, including trends in:

1) customer satisfaction and feedback from relevant interested parties;

2) the extent to which our quality objectives have been met;


Quality Manual

3) process performance and conformity of our products and services;

4) nonconformities and corrective actions;

5) monitoring and measurement results;

6) audit results;

7) the performance of external providers;

d) the adequacy of resources;

e) the effectiveness of actions taken to address risks and opportunities (see 6.1);

f) opportunities for improvement.

9.3.2.1 Management Review Inputs – SupplementalIn addition to the management review inputs identified in 9.3.2 to satisfy ISO 9001:2015, we include the following inputs to meet the requirements of IATF 16949:2016:

a) cost of poor quality (cost of internal and external nonconformity);

b) measures of process effectiveness;

c) measures of process efficiency;

d) product conformity;

e) assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new product (see 7.1.3.1);

f) customer satisfaction (see 9.1.2);

g) review of performance against maintenance objectives;

h) warranty performance (if applicable);

i) review of customer scorecards (where applicable);

j) identification of potential field failures identified through risk analysis (e.g., FMEA);

k) actual field failures and their impact on safety or the environment.

9.3.3 Management Review OutputsThe outputs of our management reviews include decisions and actions related to:

a) opportunities for improvement;


Quality Manual

b) any need for changes to our quality management system;

c) resource needs.

We retain documented information (records) as evidence of the results of management reviews.

9.3.3.1 Management Review Outputs – Supplemental

Our top management documents and implements an action plan when customer performance targets are not met.

10. Improvement

10.1 GeneralWe determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

These actions include:

a) improving products and services to meet requirements, as well as, to address future needs and expectations;

b) correcting, preventing, or reducing undesired effects;

c) improving the performance and effectiveness of our quality management system.

We recognize that improvements may include correction, corrective action, continual improvement, breakthrough change, innovation, and re-organization.

10.2 Nonconformity and Corrective Action

10.2.1 (untitled)When a nonconformity occurs, including any arising from complaints, we:

a) react to the nonconformity and, as applicable:

1) act to control and correct it;

2) deal with the consequences;

b) evaluate the need for action to eliminate the causes of the nonconformity, in order that it does not recur or occur elsewhere, by:

1) reviewing and analyzing the nonconformity;


Quality Manual

2) determining the causes of the nonconformity;

3) determining if similar nonconformities exist, or could potentially occur;c) implement any action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportunities determined during planning, if necessary;

f) make changes to our quality management system, if necessary.

Our corrective actions will be appropriate to the effects of the nonconformities encountered.

10.2.2 (untitled)

We retain documented information (records) as evidence of the:

a) nature of the nonconformities and any subsequent actions taken;

b) results of any corrective action.

10.2.3 Problem SolvingWe use a documented process for problem solving that includes:

a) defined approaches for various types and scale of problems (e.g., new product development, current manufacturing issues, field failures, audit findings);

b) containment, interim actions, and related activities necessary for control of nonconforming outputs (see 8.7);

c) root cause analysis, methodology used, analysis, and results;

d) implementation of systemic corrective actions, including consideration of the impact on similar processes and products;

e) verification of the effectiveness of implemented corrective actions;

f) reviewing and, where necessary, updating the appropriate documented information, e.g., PFMEA, control plan.

Where the customer has specific prescribed processes, tools, or systems for problem solving, we use them unless otherwise approved by customer.

10.2.4 Error-ProofingWe use a documented process to determine the use of appropriate error-proofing methodologies.Details of the method used are documented in the process risk analysis (e.g., PFMEA) and the test frequencies are documented in the control plan.


Quality Manual

The process includes testing of error-proofing devices for failure or simulated failure, as well as, maintaining records. Challenge parts, when used, are identified, controlled, verified, and calibrated when feasible. Error-proofing device failures have a reaction plan.

10.2.5 Warranty Management SystemWhen required to warranty for our products, we use a warranty management process. We include in the process a method for warranty part analysis, including NTF (no trouble found). When specified by the customer, we will implement the required warranty management process.

10.2.6 Customer Complaints and Field Failure Test AnalysisWe perform analysis on customer complaints and field failures, including any returned parts. We initiate problem solving and corrective action to prevent recurrence.

Where requested by the customer, we include analysis of the interaction of embedded software of our product within the system of the final customer’s product.

We communicate the results of testing/analysis to the customer and within our organization.

10.3 Continual improvementWe continually improve the suitability, adequacy, and effectiveness of our quality management system.

We consider the results of analysis and evaluation, and outputs from management review, to determine if there are needs or opportunities that should be addressed as part of continual improvement.

10.3.1 Continual Improvement – SupplementalWe follow a documented process for continual improvement that includes:

a) identification of the methodology used, objectives, effectiveness, and documented information;

b) a manufacturing process improvement action plan with emphasis on the reduction of process variation and waste;

c) risk analysis (e.g., FMEA).

We implement continual improvement when our manufacturing processes are statistically capable and stable, or when product characteristics are predictable and meet customer requirements.


Quality Manual

Appendix: Document References

Document Number

Clause Number Document Title (edit this table to refer to your procedures and documents)

(ISO 9001:2015-related in regular font; IATF 16949:2016-related in Italics)

4. Context of the Organizationxxxxxx 4.3 Scope of quality management system

4.3.1 Justification for scope exclusion of product design and development

4.4.1.2 Processes for management of product-safety related products and manufacturing processes

4.4.2 Documented information to extent necessary to support operation of processes5. Leadership

5.2.2.a Quality policy

5.1.1.1 Corporate responsibility policies, including anti-bribery policy, employee code of conduct, and ethics escalation policy

5.3.1 Personnel assignments for responsibility to ensure customer requirements are met6. Planning

6.1.2.3 Contingency plans6.2.1 Quality objectives

7. Support7.1.5.2.1 Process for managing calibration and verification records7.1.5.3.1 Laboratory scope7.2.1 Process for identifying training and awareness needs and achieving competence of

personnel7.2.3 Process to verify internal auditors are competent7.3.1 Documented information that demonstrates all employees are aware of their impact

on product quality, importance of their activities, and risks for customer with nonconforming product

7.3.2 Process to motivate employees to achieve quality objectives, make improvements, and innovate

7.5.1.a Documented information required by the standard7.5.1.b Documented information determined as necessary for effectiveness of QMS7.5.1.1 Quality manual7.5.1.1.a Scope of QMS and details and justification for any exclusions (see 4.3 and 4.3.1)7.5.1.1.b Documented processes or reference to them7.5.1.1.c Processes and their sequence and interactions, and control of any outsourced

processes7.5.1.1.d Matrix indicating where customer-specific requirements are addressed7.5.3.2 Documented information of external origin needed to plan and operate the QMS7.5.3.2.1 Record retention policy7.5.3.2.2 Process to review, distribute, and implement customer engineering specifications and

revisions8. Operations

8.1.e.1 Documented information necessary to have confidence processes are carried out as planned

8.1.e.2 Documented information necessary to demonstrate product and service conformity8.2.4 Amended documents when product and service requirements are changed8.3.1.1 Process for design and development


Quality Manual

8.3.2.j Documented information needed to demonstrate design and development requirements were met

8.3.3.1 Product design input requirements from contract reviewDocument Number

Clause Number Document Title

8. Operations 8.3.3.2 Manufacturing process design input requirements8.3.3.3 Process to identify special characteristics8.3.3.3.a Documents with special characteristics identified with special markings8.3.5.2 Manufacturing process design output8.4.1.1 Supplier selection process8.4.1.2 Process to identify outsourced processes and select controls8.4.2.2 Process to ensure purchased products, processes, and services met legal requirements

for country of receipt, country of shipment, and country of destination, if provided8.4.2.4 Process and criteria to evaluate supplier performance8.4.2.4.1 Criteria for determining need, type, frequency, and scope of second-party audits8.5.1.a.1 Documented information that defines characteristics of products, services, and

activities8.5.1.a.2 Documented information that defines the results to be achieved8.5.1.1 Control plans (and reaction plans)8.5.1.2 Standardized work documents, e.g., operator instructions, visual standards, and safety

rules8.5.1.3 Job set-up documents8.5.1.5 Total productive maintenance system8.5.1.5.d Maintenance objectives, e.g., OEE, MTBF, MTTR, and PM compliance8.5.1.5 Action plan to address corrective actions when objectives not achieved8.5.1.6.e Tool design modification documentation8.5.1.6.f Tool modification and revision to documentation8.5.1.7 Production schedule8.5.2.1 Traceability plan8.5.5.2 Customer service agreement, if applicable8.5.6.1 Process to control and react to changes that impact product realizations8.5.6.1.1 List of process controls8.5.6.1.1 Process for managing use of alternate control methods8.5.6.1.1 List of approved alternate process control methods 8.5.6.1.1 Standardized work instructions for each alternate process control method8.5.6.1.1 Restart verification for a defined period8.6.1 Planned arrangements to verify products and services are documented per control

plan8.7.1.4 Disassembly or rework instructions8.7.1.4 Process for rework confirmation8.7.1.5 Process for repair confirmation 8.7.1.5 Disassembly or repair instructions8.7.1.7 Process for disposition of nonconforming product not subject to rework or repair

9. Performance Evaluation9.1.1.1 Corrective action plan to ensure process becomes stable and statistically capable9.2.2.1 Internal audit process (QMS, manufacturing process, and product)9.3.3.1 Action plan when customer performance targets are not met

10. Improvement10.2.3 Process for problem solving


Quality Manual

10.2.4 Process to determine use of appropriate error-proofing methodologies10.2.4 Details of methods in process risk analysis10.2.4 Test frequencies in control plan10.3.1 Process for continual improvement

Change History

Revision Author Revision Date Revision Description

0.0 (author name) xx/xx/17 Initial Release
