16949 Sample Manual

XYZ COMPANYIATF 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. .............................................. 9 1...................................................2........................................... 17 5...................................................1 Corporate responsibility...................................................... 13 4..........................................................................1...................................................................................................................................................12 4............................3..............................................................17 4...................................................................................... 19 5..................................................3 Quality policy statement....2 Customer-specific requirements.3 Process owners......1.......2 Product safety.......................................................................................1.........2 Customer focus....... 19 5....1.......................................2 Policy.......................................................................................................................................................................................................................................0 TERMS AND DEFINITIONS................. 19 5.....................................................................2 Applicability.......................................................................... 1 DATE: xx/xx/xx PAGE 2 OF 17 Table of Contents Introduction................................ 17 5.................................................................................1 Conformance of products and processes.......... 13 4...................................... 18 5..........1 General...........................1.................9 1.......................................... 9 1......................... 18 5......... XYZ COMPANY IATF 16949 QUALITY MANUAL REV....11 4............................. 8 1....1 Establishing the quality policy.................................................2 Process effectiveness and efficiency..........0 LEADERSHIP...................1 Leadership and commitment......11 3............................13 4.......2 Understanding the needs and expectations of interested parties..................................................................12 4....0 CONTEXT OF THE ORGANIZATION........................................................4 Quality management system and its processes................................1...1 Products and services..................1 Understanding the organization and its context.13 4............................... 10 2............................17 5.......................................................................................................................................................................................... 19 5..................................................................................................................2........................................................3............... 17 5.......................................................supplemental....................................................12 4....................................................................2 Communicating the quality policy........................1.....................................................................1............................1 Determining the scope of the quality management system ........... 20 ...........0 COMPANY HISTORY AND CONTACT INFORMATION.......................................4.......................................................................................................................................................................................1.............................................0 SCOPE...............4...........................................................................................3 Determining the scope of the quality management system..1.... ..............30 7...................................... and equipment planning................................2 Preventive action......................... facility...........................................................................1 Plant...............................................................................................................2 Responsibility and authority for product requirements and corrective actions...........1.............................1....................... 25 6.2....3 Classification of quality objectives..................1..........................................4 Key initiatives...............................................5 Management representative................. 29 7.. responsibilities and authorities................................................................................ 28 7..................1 Risk analysis........3... 30 7.....3 Planning of changes............................................................................................2 Planning to achieve quality objectives..1..2................................................................1 Responsibilities for determination of required resources...................................................................................3 Organizational roles......... 22 5..................................................27 6......2........................ XYZ COMPANY IATF 16949 QUALITY MANUAL REV..............22 5.................................................................................................................1.......................................................1.......1.1..............4 Management responsibilities........................................................................................... 33 ....................................................................................................1 General..........................................................................................2...........................3...................................................2 Measurement traceability.................... 32 7.......5....................................................................... 32 7................................................................................................29 7............. 25 6.....1................................................................................1 Resources............................................................ 1 DATE: xx/xx/xx PAGE 3 OF 17 5....27 6.................................................... 24 6.........................1 Organizational roles.............1...................................................... 25 6....................................... 24 6.......................................................................................2.....................................................................................................2.................................................................................20 5................................1............................................................. 24 6...................................................................31 7............................................................................ and authorities – supplemental............................1................................5.......1 Environment for the operation of processes – supplemental............. 28 6........2................1...........................................................4............................................................................................. 27 6.............................. 23 6...............3....................4.........................................................1 Actions to address risk and opportunities..................2 Quality objectives and planning to achieve them..........2...............1..........1..1 General...........................4 Environment for the operation of processes.....................supplemental................................................ 29 7.................5 Monitoring and measuring resources.................. 30 7........................................1......2 Personnel safety to achieve product quality.......... 27 6.......... 31 7.............. responsibilities................. 30 7..........................................................................................................1...................................................2.............................................1 General............................. 32 7....1........24 6...............................0 PLANNING...........22 5....0 SUPPORT..................................................................................1.....................................................................2 People............................................................................... 30 7......................1..........................................................................1 Quality objectives and planning to achieve them .........2 Provision of resources..................2...................3 Infrastructure.......3 Contingency plans........................................ 28 6................................... ............................................................................................................. 35 7.....2 Employee motivation and empowerment.................................4......................................................................................... 36 7.....6 Organizational knowledge............................4 Second-party auditor competency............... XYZ COMPANY IATF 16949 QUALITY MANUAL REV.2 Quality system manual................................................2.................................................................................2............................................1.............................1....................................................... 39 7.......5 Documented information..........................................................5............................................................................................3 External communication......1............................. 40 .........4.......................................2 Competence...............................4...................................2........................................................................1 Quality management system documentation......................... 39 7............................................................................ awareness and training................................3 Control of documented information.. 38 7........2...... 35 7..........................2 Internal communication. 35 7..2 Creating and updating...................................................5................. 34 7................................................................3...............................................................................40 7......................... 38 7................................................2.......................................... 39 7.................................................................1 Awareness – supplemental............................................................................................... 39 7...3.................................................3 Internal auditor competency...........................................................................3 Awareness...................3 Laboratory requirements.................................................................................................................. 37 7....................................................1 General.............. 40 7... 37 7........................................................................................................................ 36 7.....................................................................5............................................................... 36 7.......5..............................................................2 Competence............................. 40 7..........................................1 Competence – on-the-job training......................1........4 Communication... 38 7..........................................................5......... 1 DATE: xx/xx/xx PAGE 4 OF 17 7..................2...1 General.................................................................................................................................................................................................................................................................................... 38 7...5.1 General..... ............. 58 ...... 45 8............. 53 8.........4..........................4.......56 8.....2..............................................4 Control of externally provided processes......................................1....2..45 8................ 46 8....................................................... products and services.......................................4 Design and development controls....................................................................................3..................................................................................3..................... 52 8................................................3 Customer-Directed Sources (also known as “Directed–Buy”)..............3 Design and development inputs. 43 8.......................................45 8...............4......supplemental (under control of externally provided processes...............................................3......... 53 8...............................3.............0 OPERATION.......................................................................2..3............2.....................................47 8...........6 Design and development changes....................... 43 8.........................................................................................................................................................................1 Design and development planning – supplemental..................................................................................... products and services)......... 57 8...3 Design and development of products and services....................1 Product design input.................................................4....2 Design and development planning.............3.................3.4...............................2......................................................................................1 Design and development of products and services – supplemental.........................2 Type and extent of control.............................3.5 Design and development outputs................................4 Acceptance criteria............................... 58 8.......................................................................................1 Customer communication — supplemental.....1 General ....................6........................................4.......3................................................ 43 8..........designated special characteristics...........................3...................................2......... XYZ COMPANY IATF 16949 QUALITY MANUAL REV.................2 Supplier selection process..................................................... 56 8...................2 Statutory and regulatory requirements...........3..2...................................1 Design and development outputs – supplemental...3 Organization manufacturing feasibility............................................4 Changes to requirements for products and services.......................... 49 8.................................................................... 1 DATE: xx/xx/xx PAGE 5 OF 17 8......................44 8................4...........................3 Development of products with embedded software...............................................3....... 42 8........1 General...................2 Design and development review................................. 48 8.........................47 8...........1...1 General..............................................................................3......................1......................2................................................ 43 8......................... 51 8.............2..............................41 8..........1..... 56 8.46 8.....3.................3.................1 Review of requirements related to products and services — supplemental................................................................1 Type and extent of control – supplemental...........2.............53 8........1....................................................................................................................1 Operational planning and control................2 Requirements for products and services.........................57 8..............3..............3......4.3.............1...........5.4..49 8.............................1 Planning of product and service realization..........................4...............3. 51 8.....................................................1 Determining the requirements for products and services – supplemental...........................................................................4....3....2........1 Design and development changes – supplemental.......................................... 51 8..........................................1 General................................................................................3.....................................1............................. 50 8........... 54 8.......2.....3 Confidentiality.................................................................2 Customer....................................................... 53 8.........................................................2 Operational planning and control — supplemental.......................................................................46 8........................................4....................55 8..............5.......................................55 8................................3............................. 42 8............3 Review of requirements related to products and services........................................................................................... 47 8.........................................................................2.........................1. 44 8.................2 Product design skills.3...............................................................................................................................45 8...............................3 Design and development validation.....................................2 Manufacturing process design input.......................................................................... 43 8..............3..2......... 51 8.........................................................................................................2 Determining the requirements related to products and services........................................1.................................................. 55 8..........................3.5 Product approval process.....................................................44 8.....................................................................4 Prototype programme..............................1 Customer communication.........3...................3 Special characteristics..............3........2 Manufacturing process design output......2................................................ 49 8....................................................... ........................................................................................5..............................6.......6.......................................2 Service agreement with customer......................5....4 Preservation...............67 8.....1............. 63 8............................................................................................................................................................. 72 8......................75 9...........................7......5 Verification of purchased product......7.......................4...............1 Control of production and service provision.......................... 1 DATE: xx/xx/xx PAGE 6 OF 17 8.........................................62 8..... 69 8................71 8.....................1 Control plan............... 75 8...........3 Information for external providers................................ 69 8................................ 70 8...............................................1 General.................................... and evaluation.................1............ 64 8.....................6 Acceptance criteria...... 67 8................................................................................................................................................................................1..........................................................................................5.............................................................................................3...1.....5.............65 8......................76 9...........................6.................................................................................... 72 8.................................4................5......................................5..........................5...................................................4 Verification and acceptance of conformity of externally provided products and services...............................................5....................................................................2........1...2...............................................................................2 Identification and traceability................................................. 74 8.............................................................3 Supplier quality management system development....................7 Production scheduling....... test...................1 Feedback of information from service........................3...................................................................................................................4 Control of reworked product......... 71 8..................................................5.......................5.6 Management of production tooling and manufacturing... measurement.............5...7..................................................1.........5 Total productive maintenance................................................................... 76 ..........................6.....................................................................................................4........................................................1 Purchasing information...........................................................2..............6..........1 Identification and traceability — supplemental..................................................................1............................1 Monitoring...........................4..5...................................................5........ XYZ COMPANY IATF 16949 QUALITY MANUAL REV.......................................... 61 8..................4.......................................................................... 68 8........................................1............................5.......................................................1........................................................5.........3 Verification of job set-ups.1....................... 74 8............................................................ analysis........7 Control of nonconforming outputs. 59 8..........74 8.....................................5 Control of repaired product....................................64 8........................................................3 Property belonging to customers or external providers.....................58 8..................................................................................................5...............................................................................1 Preservation – supplemental.....2.............1........ 75 9.......................................68 8................................6.....1 Control of changes – supplemental............... 73 8......1 Customer authorization for concession...3 Appearance items.........5.....0 PERFORMANCE EVALUATION.................... 68 8..................... 73 8......3 Control of suspect product.................................. 66 8....................1...5 Production and service provision.......................2 Control of nonconforming product – customer specified process................................. 61 8..........................4.2 Standardized work – operator instructions and visual standards............................................4 Verification after shutdown................5...........................................4.........................................7. 69 8.............................1........... 74 8........................ 64 8......... 62 8........72 8..............5 Post-delivery activities............66 8......... 62 8.............1.........7.......................5..................................5 Statutory and regulatory conformity....................... 61 8..............................................2 Layout inspection and functional testing......................................6 Customer notification...........................................................................................................5...7 Nonconforming product disposition...................................................... 64 8.............................................. inspection tooling and equipment....................4 Supplier monitoring....5............... 73 8..6 Release of products and services......................2 Information for external providers – supplemental..........................7............................6.... 75 8.......1..................... 70 8.............8 Validation of processes for production and service provision.....................................................................1 Release of products and services — supplemental...........................................................................................1..........................................7....6 Control of changes.... ......1 Management review outputs – supplemental.3.....1....................................................................................................................................................1 Management review – supplemental.........................................3 Problem solving...3.............1 Continual improvement – supplemental........................................ 84 10................................................... 84 10......................................................1........... 81 9.......................................................................................................................................................3..................2 Customer satisfaction........................................................................1 Customer satisfaction – supplemental....................1 Management review inputs – supplemental..........................2.................... 1 DATE: xx/xx/xx PAGE 7 OF 17 9......3.......................................3 Management review................................................. 79 9........................... 81 9............................................................................... 86 Inspection and Test Procedure...........................2.................................1 General........3 Continual improvement......................86 10.............3.....................................................2.........2..................................................................1................................................................................................................................2 Internal audit................................................................3 Analysis and evaluation.......1......................................................................................................................1................... 85 10................................................................................................................................ 81 9.......3 Management review outputs.......1 Monitoring and measurement of manufacturing processes....... 83 10................................................................................................................2..................2.................................... 77 9.....................2 Management review inputs............................................................................1..0 IMPROVEMENT...1... 83 10.............................................................2 Nonconformity and corrective action............................................................. 81 9........................................1 General.3 Application of statistical concepts........................................................ 77 9.................................................. 79 9..............1.................................................................................................................1...........1...........................2 Identification of statistical tools............................................................................................................................................................1..1............................................................................................ 92 ..... 84 10............3.............................................. XYZ COMPANY IATF 16949 QUALITY MANUAL REV.............3.........................................................................................................................................2 Quality management system audit..............2...............................................................................................................................................4 Product audit.................................................................................. 80 9............................. 77 9......6 Customer complaints and field failure test analysis......................2.................................................... 86 10..............................................82 9.......................2.......................1...............................................................................2......................................................................... 81 9......................1 Internal audit program......................................................................................................76 9...................1............................ 80 9.....1.............. 82 9......5 Warranty management systems...........................2.................................................3 Manufacturing process audit....................... 88 Corrective and Preventive Action Procedure.... 78 9.....2.........2..3........................................................................................ 78 9...83 10.......................................1....... 81 9.....3................................................................................................83 10........................... 85 10...........4 Error-proofing................1 Prioritization......................... This manual is divided into ten main sections. XYZ Company has developed and documented a quality management system. are manufactured. Automotive Quality Management System Standard. whether on-site or remote and throughout the entire automotive supply chain. The quality management system complies with the international standard IATF 16949:2016. XYZ COMPANY IATF 16949 QUALITY MANUAL REV. for production and/or service. 1 DATE: xx/xx/xx PAGE 8 OF 17 Introduction XYZ Company recognizes its responsibility as a manufacturer of quality products/provider of quality services. The quality management system is commonly referred to as the quality system or QMS. Sections 4-10 are modeled on the sectional organization of the IATF 16949:2016 standard. supporting functions. This manual also governs the creation of quality related documented information. 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. __________________________________ (Name). 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. To this end. President . This Quality Manual applies to sites of the organization where customer-specified parts. to reflect the quality system currently in use. It may be issued to customers on a controlled copy basis upon customer request. It will be revised. Sections are further subdivided into several subsections representing main quality system elements or activities. as necessary. statutory requirements. and expectations of all interested parties. rework. refer to the Risk Management Procedure. manufacturing. 4. Purchasing Procedure.1 Risk analysis XYZ Company periodically reviews lessons learned from product recalls. 6. XYZ COMPANY IATF 16949 QUALITY MANUAL REV.1 Corporate responsibility XYZ Company promotes an ethical business culture and focuses on maintaining integrity in all of its business activities.1. which also includes an escalation policy. Servicing Procedure.2 Product safety XYZ Company’s has developed and implemented a Product Safety Management Procedure to manage product safety. Inspection and Test Procedure. Process Control Procedure. refer to the Anti-Bribery Policy and Employee Code of Conduct. refer to the Risk Management Procedure.2. 5. This includes outsourced processes and parts for services.1. and Management Review Procedure. For details. scrap. The effectiveness of these actions is evaluated.1.1. field returns and repairs. For details. complaints.1. . product audits. Internal Audits Procedure. and includes them in risk analysis. XYZ Company has developed and enforces documented corporate responsibility policies. 1 DATE: xx/xx/xx PAGE 9 OF 17 4. and actions are integrated in to XYZ Company’s quality management system. regulatory.1 Conformance of products and processes XYZ Company ensures that all products and processes conform to all applicable customer. To this end. and servicing processes further support product safety initiatives. Design.4.4. For details. which affect product/service quality. which include quality objectives.2. 8.4.1.0 Operation 8.2.4.1 General XYZ Company ensures that the purchasing process is controlled such that purchased products and subcontracted 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. 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. 8. 8. XYZ Company uses an appropriate assessment methodology to assess its software development process.3. Quality objectives are measurable.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. 8.3.3 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. Planning of the realization processes is consistent with the other requirements of the organization’s quality management system.4 Key initiatives The management of XYZ Company establishes annual key initiatives. XYZ COMPANY IATF 16949 QUALITY MANUAL REV. 1 DATE: xx/xx/xx PAGE 10 OF 17 6.2. conform to specified requirements.1 Automotive product-related software or automotive products with embedded software . include business performance indicators reflecting requirements for products/services.1 Operational planning and control 8. 3.2. 1 DATE: xx/xx/xx PAGE 11 OF 17 XYZ Company require suppliers of software-related products.3.2.3 of this manual also apply to XYZ Company suppliers.3. For details refer to Section 8. this includes a software development assessment methodology. or products with embedded software to maintain software quality assurance process for its products. The requirements within Section 8. XYZ COMPANY IATF 16949 QUALITY MANUAL REV. . If all these checks and inspections are satisfactory. and the packing slips are removed from the containers. 1. receiving personnel verify the quantity of delivered units. a precision inspection/test is performed.3 On critical parts and components. as determined by the Quality Manager. 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. The purchase order is stamped “RECEIVED” and is signed and dated by the receiving inspector. any shortages or damages are noted on all copies of the delivery receipts. a copy of the purchase order is retrieved. deliverable products is subject to inspection and/or testing by Receiving Inspection. If not. or is intended for use as part of. 1. This type of inspection includes one or more of the following:  review of material certificates.2 The received containers are then moved to the designated inspection area. Upon opening the containers. and any other relevant documentation delivered with the product  receipt of. check marking and identification of packages. and evaluation of. receiving personnel signs the delivery receipt. XYZ COMPANY IATF 16949 QUALITY MANUAL REV.0 Receiving Inspection and Test 1. All receiving inspections are logged in the Receiving Inspection Log. supplier inspection records. the goods are verified against the purchase order and the packing slip. compliance certificates. and inspect all packages for any signs of tampering or damage. 1 DATE: xx/xx/xx PAGE 12 OF 17 Inspection and Test Procedure 1. when combined with records of acceptable delivered product quality  part evaluation by a designated laboratory  another method agreed with the customer . Upon receipt of products.1 All purchased material which influences the manufacture of. and are examined visually for any signs of damage. as well as completion of the remaining inspections/tests to assure that the finished products/processes conform to specified requirements. 2. products are identified with an “ACCEPT” tag [green sticker] and moved to stock..1 In-process inspection/testing is conducted to ensure that the product/process conforms to specified requirements. 2.e. The Quality Manager may request that suppliers provide objective evidence of conformance (i. as determined by the Quality Manager. first article inspection and SPC data). are aligned with the control plan and are documented as specifies in the control plan.1 For acceptance of completed products. 1.2 The Quality Manager determines the extent and scope of in-process inspection/testing based on the importance of the item. All final inspections are logged in the Final Inspection Log. certificates of conformance. final inspection/testing is utilized. Products are not released. This includes a verification of satisfactory receiving and in-process inspections/tests. test data. 3. including recording the sample size and actual measurements are recorded on the Inspection/Test & Audit Report 1.0 Final Inspection and Test 3.5 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. and previous performance. a Final Inspection/Test & Audit Report is completed. 3. it shall be positively identified and recorded in receiving inspection records. 1 DATE: xx/xx/xx PAGE 13 OF 17 Results of such inspection/test. to verify that the products and service requirements have been satisfied. In the event that product which is designated for receiving inspection is released to production due to urgency.0 In-process Inspection and Test 2. XYZ COMPANY IATF 16949 QUALITY MANUAL REV. Objective evidence provided by suppliers may be used as the basis for reducing/waiving receiving and source inspection. material certifications. control methods. 1.4 Where it is not practical to perform receiving inspection upon receipt. processes are not approved until all inspection/test activities have been satisfactorily completed and the appropriate documentation is available and authorized. 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.6 Upon acceptance. On critical parts and components. provisions are made to perform source inspection at the supplier’s facility. .2 XYZ Company ensures the planned arrangement. . 4.1 Inspection/test records.6 The Quality Manager determines the extent and scope of final inspection/testing based on the importance of the item. are established and maintained. 1 DATE: xx/xx/xx PAGE 14 OF 17 3. XYZ COMPANY IATF 16949 QUALITY MANUAL REV.0 Inspection and Test Records 4.1 All material/products that are found to be nonconforming are identified and segregated and/or quarantined. XYZ Company ensures that product or services approvals are obtained in accordance with section 8. 3. 3.0 Nonconforming Material/Products 5.3 XYZ Company ensures that the planned arrangements for initial release of products and services encompass product or services approval. Results are available for customer review.5. which show clearly whether the product/process has passed or failed the defined acceptance criteria.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. 5. and previous performance. 3.4 When changes occur after initial release. and appropriately dispositioned per the Control of Nonconforming Product Procedure.6. control methods. is conducted by the responsible function. requests implementation of corrective actions from the responsible function. operations. The Quality Manager. This includes nonconforming material received from a supplier. The Quality Manager records all CARs in the Corrective Action Status Log and SCARs in the Supplier Corrective Action Status Log.1 Marketing/Sales is responsible for receiving. processing. 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. quality records and specifications. 3. 3. 1 DATE: xx/xx/xx PAGE 15 OF 17 Corrective and Preventive Action Procedure 1. 1. determines the appropriate customer response.0 Analysis and Approvals 3. . XYZ COMPANY IATF 16949 QUALITY MANUAL REV. but only the Quality Manager can issue a Supplier Corrective Action Request (SCAR).0 Initiation of Corrective/Preventive Actions 1. and responding to customer complaints. All received customer complaints are recorded in the Customer Complaints Status Log. 2. which may have contributed to the deficiency.1 Corrective actions may be requested when a condition.2 The Quality Manager evaluates every complaint and when relevant.3 Field failures are handled as described in the Servicing Procedure. 2. The investigation and analysis of the root cause and preventive measures shall be fully documented by the group or individual assigned to the problem.2 Preventive actions may be requested when potential product/process problems are identified. which is adverse to quality or which has the potential for product/process improvement is identified. 1. 2. in conjunction with the President and Sales.1 A thorough analysis of all related processes.0 Customer Complaints 2.2 Analysis of corrective action and preventive action is used as input into management reviews.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. the corrective action request is re-issued. the following problem-solving methods are used:  problem identification  containment  root cause identification  verification of effectiveness of corrective action Additionally.5 All problems are evaluated in terms of potential impact on production costs. Where the response is unsatisfactory. quality costs. The Quality Manager conducts periodic reviews/follow up to determine if the corrective and preventive actions have been implemented and are effective. safety. XYZ Company uses the prescribed format. . All problems are classified either minor or major.3 At a minimum.4 If a customer-prescribed problem-solving format exists. 3. performance. XYZ COMPANY IATF 16949 QUALITY MANUAL REV. the following methods may be used:  analysis of failure mode  capability studies  correlation diagrams  data collection  fish bone diagram (ishikawa diagram)  FMEA review  histograms  pareto analysis  probability charts  recording with corresponding graphic representations  stratification (separation of data and divisions into categories) 3. and customer satisfaction. Resolutions to all corrective and preventive actions are reviewed and approved by the Quality Manager. 1 DATE: xx/xx/xx PAGE 16 OF 17 3. reliability. are filed and maintained.0 Records 5. SCARs. XYZ COMPANY IATF 16949 QUALITY MANUAL REV. software problem reports. 5. QUALITY SYSTEMS INNOVATIONS.2 The risk management files are updated as appropriate. advisory notices. similar parts.net . returned product and post-production records. customer complaints. products.qsinnovations. 5. www.6 All department managers handle corrective /preventive actions in priority order. incident reports. recall records. surveys.1 All CARs.com Phone: 570-350-2937 Email: [email protected] Preventive Actions 4. 4. INC. The Quality Manager ensures that all action plans are carried out in a reasonable timeframe relative to the severity of the problem. 1 DATE: xx/xx/xx PAGE 17 OF 17 3. and their resolution including their verification.1 When corrective actions are implemented or when a potentially serious nonconformance is identified. and processes are analyzed to determine the required steps for effective implementation of preventive actions.