IATF 16949 Quality Manual
XYZ COMPANY
IATF 16949 QUALITY MANUAL
Order Quality Manual
DATE:
REVISION 01
UNCONTROLLED COPY
CONTROLLED COPY
Serial # _________
Issued To: ___________________________ Date: ___________
SAMPLE
Note: This sample manual only contains partial text therefore, the numbering is not consecutive.
Table of Contents
Introduction 8
1.0 Scope 9
1.1 Products and services 9
1.2 Applicability 9
1.3 Quality policy statement 10
2.0 Company history and contact information 11
3.0 Terms and definitions 11
4.0 Context of the organization 12
4.1 Understanding the organization and its context 12
4.2 Understanding the needs and expectations of interested parties 12
4.3 Determining the scope of the quality management system 13
4.3.1 Determining the scope of the quality management system - supplemental 13
4.3.2 Customer-specific requirements 13
4.4 Quality management system and its processes 13
4.4.1.1 Conformance of products and processes 17
4.4.1.2 Product safety 17
5.0 Leadership 17
5.1 Leadership and commitment 17
5.1.1 General 17
5.1.1.1 Corporate responsibility 18
5.1.1.2 Process effectiveness and efficiency 18
5.1.1.3 Process owners 19
5.1.2 Customer focus 19
5.2 Policy 19
5.2.1 Establishing the quality policy 19
5.2.2 Communicating the quality policy 20
5.3 Organizational roles, responsibilities and authorities 20
5.3.1 Organizational roles, responsibilities, and authorities – supplemental 22
5.3.2 Responsibility and authority for product requirements and corrective actions 22
5.4 Management responsibilities 22
5.5 Management representative 23
6.0 Planning 24
6.1 Actions to address risk and opportunities 24
6.1.1 24
6.1.2 24
6.1.2.1 Risk analysis 25
6.1.2.2 Preventive action 25
6.1.2.3 Contingency plans 25
6.2 Quality objectives and planning to achieve them 27
6.2.1 General 27
6.2.2 Planning to achieve quality objectives 27
6.2.2.1 Quality objectives and planning to achieve them - supplemental 27
6.2.3 Classification of quality objectives 28
6.2.4 Key initiatives 28
6.3 Planning of changes 28
7.0 Support 29
7.1 Resources 29
7.1.1 General 29
7.1.1.1 Responsibilities for determination of required resources 30
7.1.1.2 Provision of resources 30
7.1.2 People 30
7.1.3 Infrastructure 30
7.1.3.1 Plant, facility, and equipment planning 30
7.1.4 Environment for the operation of processes 31
7.1.4.1 Environment for the operation of processes – supplemental 31
7.1.4.2 Personnel safety to achieve product quality 32
7.1.5 Monitoring and measuring resources 32
7.1.5.1 General 32
7.1.5.2 Measurement traceability 33
7.1.5.3 Laboratory requirements 34
7.1.6 Organizational knowledge 35
7.2 Competence 35
7.2.1 General 35
7.2.2 Competence, awareness and training 36
7.2.2.1 Competence – on-the-job training 36
7.2.3 Internal auditor competency 36
7.2.4 Second-party auditor competency 37
7.3 Awareness 37
7.3.1 Awareness – supplemental 38
7.3.2 Employee motivation and empowerment 38
7.4 Communication 38
7.4.1 General 38
7.4.2 Internal communication 39
7.4.3 External communication 39
7.5 Documented information 39
7.5.1 General 39
7.5.1.1 Quality management system documentation 40
7.5.1.2 Quality system manual 40
7.5.2 Creating and updating 40
7.5.3 Control of documented information 40
8.0 Operation 41
8.1 Operational planning and control 42
8.1.1 Planning of product and service realization 42
8.1.2 Operational planning and control — supplemental 43
8.1.3 Confidentiality 43
8.1.4 Acceptance criteria 43
8.2 Requirements for products and services 43
8.2.1 Customer communication 43
8.2.1.1 Customer communication — supplemental 44
8.2.2 Determining the requirements related to products and services 44
8.2.2.1 Determining the requirements for products and services – supplemental 44
8.2.3 Review of requirements related to products and services 45
8.2.3.1 Review of requirements related to products and services — supplemental 45
8.2.3.2 Customer- designated special characteristics 45
8.2.3.3 Organization manufacturing feasibility 45
8.2.4 Changes to requirements for products and services 46
8.3 Design and development of products and services 46
8.3.1 General 46
8.3.1.1 Design and development of products and services – supplemental 47
8.3.2 Design and development planning 47
8.3.2.1 Design and development planning – supplemental 47
8.3.2.2 Product design skills 48
8.3.2.3 Development of products with embedded software 49
8.3.3 Design and development inputs 49
8.3.3.1 Product design input 49
8.3.3.2 Manufacturing process design input 50
8.3.3.3 Special characteristics 51
8.3.4 Design and development controls 51
8.3.4.1 General 51
8.3.4.2 Design and development review 51
8.3.4.3 Design and development validation 52
8.3.4.4 Prototype programme 53
8.3.4.5 Product approval process 53
8.3.5 Design and development outputs 53
8.3.5.1 Design and development outputs – supplemental 53
8.3.5.2 Manufacturing process design output 54
8.3.6 Design and development changes 55
8.3.6.1 Design and development changes – supplemental 55
8.4 Control of externally provided processes, products and services 55
8.4.1 General 56
8.4.1.1 General - supplemental (under control of externally provided processes, products and services) 56
8.4.1.2 Supplier selection process 56
8.4.1.3 Customer-Directed Sources (also known as “Directed–Buy”) 57
8.4.2 Type and extent of control 57
8.4.2.1 Type and extent of control – supplemental 58
8.4.2.2 Statutory and regulatory requirements 58
8.4.2.3 Supplier quality management system development 58
8.4.2.4 Supplier monitoring 59
8.4.2.5 Verification of purchased product 61
8.4.3 Information for external providers 61
8.4.3.1 Purchasing information 61
8.4.3.2 Information for external providers – supplemental 62
8.5 Production and service provision 62
8.5.1 Control of production and service provision 62
8.5.1.1 Control plan 63
8.5.1.2 Standardized work – operator instructions and visual standards 64
8.5.1.3 Verification of job set-ups 64
8.5.1.4 Verification after shutdown 64
8.5.1.5 Total productive maintenance 64
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment 65
8.5.1.7 Production scheduling 66
8.5.1.8 Validation of processes for production and service provision 66
8.5.2 Identification and traceability 67
8.5.2.1 Identification and traceability — supplemental 67
8.5.3 Property belonging to customers or external providers 68
8.5.4 Preservation 68
8.5.4.1 Preservation – supplemental 68
8.5.5 Post-delivery activities 69
8.5.5.1 Feedback of information from service 69
8.5.5.2 Service agreement with customer 69
8.5.6 Control of changes 70
8.5.6.1 Control of changes – supplemental 70
8.6 Release of products and services 71
8.6.1 Release of products and services — supplemental 71
8.6.2 Layout inspection and functional testing 72
8.6.3 Appearance items 72
8.6.4 Verification and acceptance of conformity of externally provided products and services 72
8.6.5 Statutory and regulatory conformity 73
8.6.6 Acceptance criteria 73
8.7 Control of nonconforming outputs 73
8.7.1.1 Customer authorization for concession 74
8.7.1.2 Control of nonconforming product – customer specified process 74
8.7.1.3 Control of suspect product 74
8.7.1.4 Control of reworked product 74
8.7.1.5 Control of repaired product 75
8.7.1.6 Customer notification 75
8.7.1.7 Nonconforming product disposition 75
9.0 Performance evaluation 75
9.1 Monitoring, measurement, analysis, and evaluation 76
9.1.1 General 76
9.1.1.1 Monitoring and measurement of manufacturing processes 76
9.1.1.2 Identification of statistical tools 77
9.1.1.3 Application of statistical concepts 77
9.1.2 Customer satisfaction 77
9.1.2.1 Customer satisfaction – supplemental 78
9.1.3 Analysis and evaluation 78
9.1.3.1 Prioritization 79
9.2 Internal audit 79
9.2.1.1 Internal audit program 80
9.2.1.2 Quality management system audit 80
9.2.1.3 Manufacturing process audit 81
9.2.1.4 Product audit 81
9.3 Management review 81
9.3.1 General 81
9.3.1.1 Management review – supplemental 81
9.3.2 Management review inputs 81
9.3.2.1 Management review inputs – supplemental 82
9.3.3 Management review outputs 82
9.3.3.1 Management review outputs – supplemental 83
10.0 Improvement 83
10.1 General 83
10.2 Nonconformity and corrective action 83
10.2.1 84
10.2.2 84
10.2.3 Problem solving 84
10.2.4 Error-proofing 85
10.2.5 Warranty management systems 85
10.2.6 Customer complaints and field failure test analysis 86
10.3 Continual improvement 86
10.3.1 Continual improvement – supplemental 86
Inspection and Test Procedure 88
Corrective and Preventive Action Procedure 92
Introduction
XYZ Company recognizes its responsibility as a manufacturer of quality products/provider of quality services. To this end, XYZ Company has developed and documented a quality management system. The quality management system complies with the international standard IATF 16949:2016, Automotive Quality Management System Standard. The quality management system is commonly referred to as the quality system or QMS.
This Quality Manual applies to sites of the organization where customer-specified parts, for production and/or service, are manufactured, supporting functions, whether on-site or remote and throughout the entire automotive supply chain.
The purpose of this manual is to provide comprehensive evidence to all customers, suppliers and employees of what specific controls are implemented to ensure product/service quality. This manual also governs the creation of quality related documented information. It will be revised, as necessary, to reflect the quality system currently in use. It is issued on a controlled copy basis to all internal functions affected by the quality management system and on an uncontrolled copy basis to customers and suppliers. It may be issued to customers on a controlled copy basis upon customer request.
This manual is divided into ten main sections. Sections 4-10 are modeled on the sectional organization of the IATF 16949:2016 standard. Sections are further subdivided into several subsections representing main quality system elements or activities.
__________________________________
(Name), President
4.4.1.1 Conformance of products and processes
XYZ Company ensures that all products and processes conform to all applicable customer, regulatory, statutory requirements, and expectations of all interested parties. This includes outsourced processes and parts for services. For details, refer to the Risk Management Procedure, Process Control Procedure, Inspection and Test Procedure, Purchasing Procedure, Servicing Procedure, Internal Audits Procedure, and Management Review Procedure.
4.4.1.2 Product safety
XYZ Company’s has developed and implemented a Product Safety Management Procedure to manage product safety. Design, manufacturing, and servicing processes further support product safety initiatives.
5.1.1.1 Corporate responsibility
XYZ Company promotes an ethical business culture and focuses on maintaining integrity in all of its business activities. To this end, XYZ Company has developed and enforces documented corporate responsibility policies. For details, refer to the Anti-Bribery Policy and Employee Code of Conduct, which also includes an escalation policy.
6.1.2.1 Risk analysis
XYZ Company periodically reviews lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, rework, and includes them in risk analysis. The effectiveness of these actions is evaluated, and actions are integrated in to XYZ Company’s quality management system. For details, refer to the Risk Management Procedure.
6.2.4 Key initiatives
The management of XYZ Company establishes annual key initiatives, which include quality objectives. The objectives are established via the Management Review Procedure and communicated to all levels of the organization for use in establishing each function’s and employee’s annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for products/services, and are consistent with the quality policy including the commitment to continuous improvement. The use of quality objectives for facilitating continual improvement is explained in the Continual Improvement Procedure.
8.0 Operation
8.1 Operational planning and control
8.1.1 Planning of product and service realization
XYZ Company has established and maintains a documented Product and Service Realization Planning Procedure to ensure that processes and sub-processes are conducted under controlled conditions. Planning of the realization processes is consistent with the other requirements of the organization’s quality management system.
8.3.2.3 Development of products with embedded software
XYZ Company maintains and follows a documented a software quality assurance process for products with internally developed embedded software. XYZ Company uses an appropriate assessment methodology to assess its software development process.
8.4.1 General
XYZ Company ensures that the purchasing process is controlled such that purchased products and subcontracted services, which affect product/service quality, conform to specified requirements.
8.4.2.3.1 Automotive product-related software or automotive products with embedded software
XYZ Company require suppliers of software-related products, or products with embedded software to maintain software quality assurance process for its products, this includes a software development assessment methodology. The requirements within Section 8.3.2.3 of this manual also apply to XYZ Company suppliers. For details refer to Section 8.3.2.3.
Inspection and Test Procedure
1. Receiving Inspection and Test
1. All purchased material which influences the manufacture of, or is intended for use as part of, deliverable products is subject to inspection and/or testing by Receiving Inspection. Upon receipt of products, receiving personnel verify the quantity of delivered units, check marking and identification of packages, and inspect all packages for any signs of tampering or damage. If all these checks and inspections are satisfactory, receiving personnel signs the delivery receipt. If not, any shortages or damages are noted on all copies of the delivery receipts.
2. The received containers are then moved to the designated inspection area, a copy of the purchase order is retrieved, and the packing slips are removed from the containers. Upon opening the containers, the goods are verified against the purchase order and the packing slip, and are examined visually for any signs of damage. The purchase order is stamped “RECEIVED” and is signed and dated by the receiving inspector. All receiving inspections are logged in the Receiving Inspection Log.
3. On critical parts and components, as determined by the Quality Manager, a precision inspection/test is performed. This type of inspection includes one or more of the following:
• review of material certificates, supplier inspection records, compliance certificates, and any other relevant documentation delivered with the product
• receipt of, and evaluation of, statistical data
• random sampling based on statistical technique specified
• 100% Inspection/testing if necessary
• visual inspection to detect any damage or other visible problems
• performing measurements and testing against specified requirements
• second or third party assessments or audits of supplier sites, when combined with records of acceptable delivered product quality
• part evaluation by a designated laboratory
• another method agreed with the customer
Results of such inspection/test, including recording the sample size and actual measurements are recorded on the Inspection/Test & Audit Report
4. Where it is not practical to perform receiving inspection upon receipt, provisions are made to perform source inspection at the supplier’s facility.
5. The Quality Manager determines the extent and scope of receiving inspection based on the importance of the item and the suppliers’ control methods and performance. The Quality Manager may request that suppliers provide objective evidence of conformance (i.e., material certifications, certificates of conformance, test data, first article inspection and SPC data). Objective evidence provided by suppliers may be used as the basis for reducing/waiving receiving and source inspection.
6. Upon acceptance, products are identified with an “ACCEPT” tag [green sticker] and moved to stock. In the event that product which is designated for receiving inspection is released to production due to urgency, it shall be positively identified and recorded in receiving inspection records.
2. In-process Inspection and Test
1. In-process inspection/testing is conducted to ensure that the product/process conforms to specified requirements. The inspection/testing is normally carried out by production personnel. Random audits of the in-process inspection/testing process are conducted by quality control personnel.
2. The Quality Manager determines the extent and scope of in-process inspection/testing based on the importance of the item, control methods, and previous performance.
3. Final Inspection and Test
1. For acceptance of completed products, final inspection/testing is utilized. This includes a verification of satisfactory receiving and in-process inspections/tests, as well as completion of the remaining inspections/tests to assure that the finished products/processes conform to specified requirements. Products are not released, processes are not approved until all inspection/test activities have been satisfactorily completed and the appropriate documentation is available and authorized. All final inspections are logged in the Final Inspection Log. On critical parts and components, as determined by the Quality Manager, a Final Inspection/Test & Audit Report is completed.
2. XYZ Company ensures the planned arrangement, to verify that the products and service requirements have been satisfied, are aligned with the control plan and are documented as specifies in the control plan.
3. XYZ Company ensures that the planned arrangements for initial release of products and services encompass product or services approval.
4. When changes occur after initial release, XYZ Company ensures that product or services approvals are obtained in accordance with section 8.5.6.
5. A layout inspection and a functional verification to applicable customer engineering material and performance standards is performed for each product as specified in the control plans. The frequency of layout inspections is determined by the customer. Results are available for customer review.
6. The Quality Manager determines the extent and scope of final inspection/testing based on the importance of the item, control methods, and previous performance.
4. Inspection and Test Records
1. Inspection/test records, which show clearly whether the product/process has passed or failed the defined acceptance criteria, are established and maintained.
5. Nonconforming Material/Products
1. All material/products that are found to be nonconforming are identified and segregated and/or quarantined, and appropriately dispositioned per the Control of Nonconforming Product Procedure.
Corrective and Preventive Action Procedure
1. Initiation of Corrective/Preventive Actions
1. Corrective actions may be requested when a condition, which is adverse to quality or which has the potential for product/process improvement is identified. This includes nonconforming material received from a supplier.
2. Preventive actions may be requested when potential product/process problems are identified.
3. Any employee of the company can initiate a corrective/preventive action request by completing the top portion of the Corrective Action Request (CAR) form, but only the Quality Manager can issue a Supplier Corrective Action Request (SCAR). The Quality Manager records all CARs in the Corrective Action Status Log and SCARs in the Supplier Corrective Action Status Log.
2. Customer Complaints
1. Marketing/Sales is responsible for receiving, processing, and responding to customer complaints. All received customer complaints are recorded in the Customer Complaints Status Log.
2. The Quality Manager evaluates every complaint and when relevant, requests implementation of corrective actions from the responsible function. The Quality Manager, in conjunction with the President and Sales, determines the appropriate customer response.
3. Field failures are handled as described in the Servicing Procedure.
3. Analysis and Approvals
1. A thorough analysis of all related processes, operations, quality records and specifications, which may have contributed to the deficiency, is conducted by the responsible function. The investigation and analysis of the root cause and preventive measures shall be fully documented by the group or individual assigned to the problem. The analysis shall include review of all applicable data and examination of product scrapped or reworked to determine the extent and cause of the problem and analysis of trends in processes or performance of work to prevent nonconformances.
2. Analysis of corrective action and preventive action is used as input into management reviews.
3. At a minimum, the following problem-solving methods are used:
• problem identification
• containment
• root cause identification
• verification of effectiveness of corrective action
Additionally, the following methods may be used:
• analysis of failure mode
• capability studies
• correlation diagrams
• data collection
• fish bone diagram (ishikawa diagram)
• FMEA review
• histograms
• pareto analysis
• probability charts
• recording with corresponding graphic representations
• stratification (separation of data and divisions into categories)
4. If a customer-prescribed problem-solving format exists, XYZ Company uses the prescribed format.
5. All problems are evaluated in terms of potential impact on production costs, quality costs, performance, reliability, safety, and customer satisfaction. All problems are classified either minor or major. Resolutions to all corrective and preventive actions are reviewed and approved by the Quality Manager. Where the response is unsatisfactory, the corrective action request is re-issued. The Quality Manager conducts periodic reviews/follow up to determine if the corrective and preventive actions have been implemented and are effective.
6. All department managers handle corrective /preventive actions in priority order. The Quality Manager ensures that all action plans are carried out in a reasonable timeframe relative to the severity of the problem.
4. Preventive Actions
1. When corrective actions are implemented or when a potentially serious nonconformance is identified, similar parts, products, and processes are analyzed to determine the required steps for effective implementation of preventive actions.
5. Records
1. All CARs, SCARs, customer complaints, software problem reports, surveys, returned product and post-production records, incident reports, advisory notices, recall records, and their resolution including their verification, are filed and maintained.
2. The risk management files are updated as appropriate.
QUALITY SYSTEMS INNOVATIONS, INC.
Phone: 570-350-2937
Email: qsiinc@
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