Transitioning from ISO/TS 16949:2009 to IATF 16949:2016 Presented by Brandon Kerkstra Revision: 10/24/2016

Transcription

1 Transitioning from ISO/TS 16949:2009 to IATF 16949:2016 Presented by Brandon Kerkstra Revision: 10/24/2016 1

2 For Web Training To Prepare for the training and to get the most out of this session: 1. Print a copy of the slides 2. Follow along and take notes 3. Remember you have access to the course so you can refer back if necessary 2

3 Thoughts for us to consider As we review the changes in IATF 16949:2016, think about the best place in your QMS to implement the changes and how you might verify the information in an audit: 1. How will this change your QMS or do you already cover? 2. What are changes in the Objective Evidence that you would collect? 3. What processes in your organization could be improved? 3

4 Presentation information Requirements that have significantly changed will be identified Requirements that have been expanded will be identified Notes that have become requirements will be reviewed 4

5 Section 4.3.1: Determining the scope of the quality management system supplemental IATF Section 4 (formerly sections 1.1 & 1.2): 5 Supporting functions, whether on-site or remote (such as design centers, corporate headquarters, and distribution centers), shall be included in the scope of the Quality Management System (QMS). The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented Copyright information 2016 Management (see Solutions ISO Group, 9001, Inc. Section 7.5).

6 Section 4.3.2: Customer-specific requirements Customer-specific requirements must be evaluated and included in the scope of the organization's quality management system. 6

7 Section : Conformance of products and processes The organization shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements (see Section ). The organization is responsible for the conformity of outsourced processes 7

8 Section : Product Safety Documented processes for the management of product-safety related products and manufacturing processes Process must included, but not limited to (Where applicable) items on the next page 8

9 Section : Product Safety Identification by the organization of statutory and regulatory product-safety requirements Customer notification of requirements above Special approvals for design FMEA Identification of product safety-related characteristics Identification and controls of safety-related characteristics of product and at the point of manufacture Special approval of control plans and process FMEAs Reaction plans (see Section ); Defined responsibilities, escalation process, flow of information, including top management, & customer notification Training identified by the org. or customer for personnel involved in product-safety related products & manufacturing processes Changes of product or process approved prior to implementation, including evaluation of potential effects on product safety Transfer of requirements throughout the supply chain, including customer-designated sources Product traceability by manufactured lot (at a minimum) throughout the supply chain Lessons learned for new product introduction. 9

10 Section : Corporate Responsibility ISO 9001: 2015 has increased the requirements for leadership by management. The IATF adds the following: The organization shall define and implement corporate responsibility policies, including at a minimum: Anti-bribery policy Employee code of conduct Ethics escalation policy 10

11 Section : Process effectiveness & efficiency The requirement to review processes to ensure effectiveness and efficiency now encompasses: Top management shall review the product realization processes and support processes to evaluate and improve their effectiveness and efficiency. Including the results of process review activities in 11

12 Section : Process Owners Section requires management to: Identifying process owners and Assure they are competent to perform their assigned roles. 12

13 Section 5.3.1: Organizational roles, responsibilities, & authorities supplemental This modified requirement now addresses the 13 need to: Document assigned personnel responsibilities and authorities; Not only address but MEET customer requirements; and This includes but is not limited to the selection of special characteristics, setting quality objectives

14 Section 5.3.2: Responsibility and authority for product requirements and corrective actions Top management shall ensure that: 14 Personnel responsible for conformity to product requirements have the authority to stop shipment & stop production to correct quality problems Personnel with authority & responsibility for corrective action are promptly informed of products / processes nonconformances to ensure that nonconforming product is not shipped to the customer, is identified and contained All shifts are Copyright staffed 2016 Management with personnel Solutions Group, in Inc. charge of, or

15 Section : Risk Analysis Additional requirements for risk analysis now include: At a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework. Retaining documented information (Records) as evidence of the results of risk analysis 15

16 Section : Preventive action Actions to eliminate the causes of potential nonconformities to prevent their occurrence Appropriate to the severity of the potential issues. Process to lessen the impact of negative effects of risk including the following: Determining potential nonconformities and their causes; 16 Evaluating the need for action to prevent occurrence of nonconformities; Determining and implementing action needed;

17 Section : Contingency Plans This section requires the organization to define and prepare contingency plans. A systematic approach should be taken to identify and evaluate risk for all manufacturing processes, particularly external risk. Contingency plans should be developed for: 17 disruption conditions -- interruption of externally provided products, processes, and services, key equipment failures

18 Section : Quality objectives and planning to achieve them supplemental Ensure that quality objectives to meet customer requirements are defined for relevant functions, processes, and levels throughout the organization Results of the interested parties and their relevant requirements review must be considered when the organization establishes its annual (at a minimum) quality objectives and related performance targets (internal and external). 18

19 Section : Plant, facility, and equipment planning Multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. In designing plant layouts, the organization shall: 19 Optimize material flow, material handling, and valueadded use of floor space including control of nonconforming product, and Facilitate synchronous material flow, as applicable.

20 Section : Measurement system analysis Statistical studies conducted to analyze the variation present in the results of each type of inspection, measurement, and test equipment system identified in the control plan Analytical methods and acceptance criteria used must conform to MSA manual Other methods and acceptance criteria may be used if approved by the customer (Must have 20 records)

21 Section : Calibration/verification records Documented process for managing calibration / verification records. Records needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements 21

22 Section : Calibration/verification records Revisions following engineering changes Out-of-specification readings as received for calibration/verification; Assessment of the risk of the intended use of the product caused by the out-ofspecification condition; M&TE with AS-Found: calibration data out of tolerance records of evaluation of previous measurement results Notification to the customer if suspect product or material has been shipped; statements of conformity to specification after calibration/verification; verification that the software version used for product and process control is as specified; records of the calibration and maintenance activities for all gauging (including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment); production-related software verification used for product and process control 22

23 Section : External laboratory Org. assessments or second party are allowed when approved by customer Calibration requirements are increased to 23 accreditation the laboratory shall be accredited to ISO/IEC or national equivalent and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national

24 Section 7.2.1: Competence supplemental Document processes for identifying training needs Awareness, is a new requirement which would typically include: Quality policy, quality objectives, personnel contribution to the QMS, benefits of improved performance, and implications of not conforming with QMS requirements. Focus on satisfaction of customer requirements Qualified for specific assigned tasks 24

25 Section 7.2.2: Competence on-the-job training Provide on-the-job training (which shall include customer requirements training) Includes contract or agency personnel Includes new or modified responsibilities Informed about the consequences of nonconformity to customer requirements. 25

26 Section 7.2.3: Internal auditor competency Organizations need to: 26 Provide a documented process to verify competence (Including any customer specific requirements) Record a list of the approved auditors Approved auditors competent on process approach, risk based thinking, customer specifics, ISO 9001 & IATF 16949, Core tools, Plan, report, close findings The clause differentiates between quality management system auditors, manufacturing

27 Section 7.2.3: Internal auditor competency Maintenance of and improvement in internal auditor competence shall be demonstrated through: executing a minimum number of audits per year, as defined by the organization; and maintaining knowledge of relevant requirements based on internal and eternal changes (e.g. core tools updates ) 27

28 Section 7.2.4: Second-party auditor competency Requirements for second-party auditors are outlined to ensure they are properly qualified to conduct those types of audits, with customer specific requirements being a main focus. The same core competencies that apply to internal auditors should, at a minimum, also apply to second-party auditors. 28

29 Section 7.3.1: Awareness supplemental Maintain documented information that demonstrates that all employees are aware of their impact on: The organization s product quality output Customer specific requirements Risks involved for the customer should non-conforming product be released 29

30 Section 7.3.2: Employee motivation and empowerment This section now requires "maintain[ing] a documented process(es)" for employee motivation and empowerment, instead of simply "having a process." 30

31 Section : Quality management system documentation Quality Manual is a requirement for IATF It can be one main document or a series of multiple documents (hard copy / electronic). Requirements are: Scope & Justification for any exclusions References to the documented QMS processes Organization s processes and sequence & interactions including type and extent of control of 31

32 Section : Record retention Define, document, implement a record retention 32 policy Statutory, regulatory, organizational, and customer requirements PPAPs, tooling records (including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts and amendments Kept for production and service + one calendar year

33 Section : Engineering specifications Documented process describing the review, distribution, implementation of customer engineering standards/specifications Customer Schedules When Spec changes = design changes reference ISO 9001 section When spec changes = Process changes reference ISO 9001 section

34 Section 8.1.1: Operational planning and control supplemental When planning for product realization, the following topics shall be included: 34 Customer product requirements and tech specs Logistics requirements Manufacturing feasibility Project Planning see ISO Acceptance criteria ISO c resources refer to required verification, validation, monitoring, measurement,

35 Section : Customer communication supplemental Requirement now includes that the communication language (written or verbal) must be agreed upon with the customer. 35

36 Section : Determining the requirements for products and services supplemental Requirements for products and services include 36 recycling, environmental impact, and characteristics identified as a result of the organization's knowledge of the product and manufacturing processes. Compliance to ISO 9001, Section item a) 1, includes but is not limited to: all applicable government, safety, and environmental regulations related to acquisition, Copyright 2016 Management storage, Solutions Group, handling, Inc. recycling,

37 Section : Review of the requirements for products and services supplemental Shall retain documented evidence of a customerauthorized waiver for the requirements stated in ISO 9001, Section , for a formal review. 37

38 Section : Organization manufacturing feasibility Manufacturing feasibility analysis now includes the following changes: Requiring a multidisciplinary approach to analyze 38 feasibility, Considering all engineering and capacity requirements specified Feasibility analysis for any manufacturing or product technology new to the organization and any

39 Section : Design and development of products and services supplemental The requirements of ISO 9001, Section applies to product and manufacturing process design and development and focuses on error prevention rather than detection. Documented design and development process is required 39

40 Section : Design and development planning supplemental Design and development planning includes all affected stakeholders (Include supply chain, where appropriate) Examples include, but are not limited to: 40 Project management (for example, APQP or VDA-RGA) Product and manufacturing process design activities (DFM, DFA, alternative designs & Mfg processes) Design FMEAs, design risk analysis including risk reduction

41 Section : Development of products with embedded software A process for quality assurance for products with internally developed embedded software is req. Software development assessment methodology is required to assess the process Records of a software development capability selfassessment using risk prioritization 41

42 Section : Product design input Product design input requirements include, but are not limited to, the following: Product specifications & special characteristics (see Section ) Boundary and interface requirements Identification, traceability, and packaging Consideration of design alternatives Assessment of risks with the input requirements 42

43 Section : Manufacturing process design input Document, and review mfg. process design input requirements including but not limited to: product design output data including special 43 characteristics targets for productivity, process capability, timing, and cost manufacturing technology alternatives customer requirements, if any Error-proofing methods to a degree appropriate to the magnitude of the problem(s) and commensurate with the risks encountered now required

44 Section : Special characteristics Multidisciplinary approach to special characteristics identification including customer identified and as identified by risk analysis, including: Identification on drawings, FMEA, Control plans, instructions.. Development of control & monitoring (Products & Processes) Customer specified approvals, when required 44 Compliance with customer specified definitions &

45 Section : Monitoring Measurements at specified stages during the design and development of products and processes shall be defined, analyzed, and reported Summary results input to Management Review As required by customer, measurements of product & process development shall be reported 45

46 Section : Design and development validation Design and development validation in accordance with customer requirements Including any applicable industry and governmental agency-issued regulatory standards Timing in alignment with customer specified 46 schedules Evaluation of the interaction of the organization's product, including embedded software, within the system of the Copyright final 2016 customer's Management Solutions Group, product, Inc. as required

47 Section : Prototype program Prototype program and control plan when required 47 by the customer Whenever possible, the same suppliers, tooling, and manufacturing processes as production. Performance-testing monitored for timely completion and conformity to requirements When outsourced, include type and extent of control in scope of QMS

48 Section : Product approval process Product and manufacturing approval process conforming to requirements defined by the customer Approve externally provided products and services per ISO 9001, Section 8.4.3, prior to Cust, PPAP Documented product approval prior to shipment, if required by customer with Records 48

49 Section : Design and development outputs supplemental (Outputs as applicable) Design risk analysis (FMEA) Reliability study results Product special characteristics Results of product design errorproofing, such as DFSS, DFMA, and FTA Product definition including 3D models, technical data packages, product Mfg information, and GD&T 2D drawings, product manufacturing information, and GD&T Product design review results; Service diagnostic guidelines and repair and serviceability instructions; Service part requirements; Packaging and labeling requirements for shipping. 49

50 Section : Manufacturing process design output Document the manufacturing process design output so that it can be verified against input requirements Verify the outputs against manufacturing process design input requirements 50

51 Section : Manufacturing process design output Outputs Include: 51 specifications and drawings; special characteristics for product and manufacturing process; identification of process input variables that impact characteristics; manufacturing process FMEA; maintenance plans and instructions; control plan (see Annex A); standard work and work instructions;

52 Section : Design and development changes supplemental Evaluate all design changes after initial product approval, including organization or supplier proposed 52 Fit, form, function, performance, and/or durability validated against customer requirements and approved internally, prior to implementation obtain documented approval, or documented waiver Embedded software document rev level of software and hardware as part of change record

53 Section : General - supplemental (under Control of externally provided processes, products and services) Includes all products and services that affect customer requirements such as sub assembly, sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products, processes, and services 53

54 Section : Supplier selection process Documented supplier selection process that 54 includes: An assessment of the selected supplier's risk to product conformity and uninterrupted supply of the organization's product to their customers Relevant quality and delivery performance An evaluation of the supplier's quality management system Multidisciplinary decision making

55 Section : Customer-directed sources (also When known specified as by Directed Buy ) the customer, the organization shall purchase products, materials, or services from customer-directed sources. All requirements of Section 8.4 (except the requirements in IATF 16949, Section ) are applicable to the organization's control of directed sources 55

56 Section : Type and extent of control supplemental Documented process to identify outsourced processes Select the types and extent of controls used to verify conformity of externally provided products, processes, and services Include the criteria and actions to escalate or reduce the types and extent of controls 56

57 Section : Statutory and regulatory requirements Document process to ensure that purchased products, processes, and services conform to statutory and regulatory requirements (Country of receipt) If the customer defines special controls for certain products with statutory and regulatory requirements: 57 Ensure they are implemented and maintained as defined, including Copyright 2016 at Management suppliers Solutions Group, Inc.

58 Section : Supplier quality management system development ISO 9001 certification required then improve with the ultimate objective of complying with IATF The following development sequence (Should) 58 ISO 9001 through second-party audits ISO 9001 Certification by an accredited registrar (IAF MLA) ISO 9001 Certification with MAQMSR or equivalent Second party audits

59 Section : Automotive productrelated software / automotive products with embedded Suppliers of SW automotive product-related software, or automotive products with embedded software: Implement and maintain a process for software quality assurance for their products. Software development assessment methodology Record of a software development capability selfassessment 59

60 Section : Supplier monitoring Documented process and criteria to evaluate supplier performance (conformity of products, processes and services). Minimum indicators: Delivered product conformity requirements Customer disruptions Delivery schedule performance Premium Freight 60

61 Section : Supplier monitoring If provided by the customer, the following, as appropriate, must be included in supplier performance monitoring Special status customer notifications related to quality or delivery issues; Dealer returns, warranty, field actions, and recalls 61

62 Section : Second-party audits Second-party audit process must be used in supplier management approach & can be used for: 62 supplier risk assessment; supplier monitoring; supplier QMS development; product audits; process audits. Based on a risk analysis, document the criteria for determining the need, type, frequency, and scope

63 Section : Supplier development Determine the priority, type, extent, and timing of required supplier development actions for its active suppliers Inputs include but are not limited to the following: 63 performance issues identified through supplier monitoring second-party audit findings (see Section ); third-party quality management system certification status;

64 Section : Information for external providers supplemental Must pass down to Suppliers all applicable statutory and regulatory requirements and special product and process characteristics And require the suppliers to cascade all applicable requirements down the supply chain to the point of manufacture. 64

65 Section : Control plan Develop control plans (See Annex A) at the system, subsystem, component, and/or material level Family control plans are acceptable for bulk material and similar parts Pre-launch and production control plans must show linkage and incorporate information from the DFMEA, process flow diagram, and manufacturing 65 PFMEA).

66 Section : Control plan (continued) Items required in the control plan: controls used for the manufacturing process control, including verification of job set-ups; first-off/last-off part validation, as applicable; methods for monitoring of control exercised over special characteristics (see Annex A) defined by both the customer and the organization; the customer-required information, if any; 66 specified reaction plan (see Annex A); when

67 Section : Control plan (continued) review control plans, and update as required, for: 67 The organization determines it has shipped nonconforming product to the customer When any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA) (see Annex A) After a customer complaint and implementation of the associated corrective action, when applicable

68 Section : Standardized work operator instructions and visual standards Standardized work document requirements: communicated to and understood by the employees who are responsible for performing the work; legible; presented in the language(s) understood by the personnel responsible to follow them; accessible for use at the designated work area(s). Also include rules for operator safety. 68

69 Section : Verification of job set-ups Verify job set-ups when performed, such as an initial run of a job, material changeover, or job change that requires a new set-up; Maintain documented information for set-up personnel; Use statistical methods of verification, where applicable; Perform first-off/last-off part validation, as 69

70 Section : Verification after shutdown The organization shall define and implement the necessary actions to ensure product compliance with requirements after a planned or unplanned production shutdown period. 70

71 Section : Total productive maintenance Documented total 71 productive maintenance system: identification of process equipment necessary to produce conforming product at the required volume; availability of documented maintenance objectives, (e.g. OEE MTBF and MTTR) and Preventive Maintenance compliance metrics. Performance to the maintenance objectives shall form an input into

72 Section : Management of prod. tooling and mfg., test, inspection tooling and Provide equipment resources for tool & gauge design, fabrication, verification activities for production, service materials & bulk materials, as applicable Verify that customer-owned tools, mfg. equipment, and test/inspection equipment permanently marked in a visible location Includes any work outsourced 72

73 Section : Management of prod. tooling and mfg., test, inspection tooling and equipment System for production tooling management; owned by the organization or the customer, including: 73 maintenance and repair facilities and personnel storage and recovery set-up tool-change programs for perishable tools tool design modification documentation, including eng. change level of the product tool modification Copyright and 2016 Management revision Solutions to Group, documentation; Inc.

74 Section : Production scheduling Production is scheduled in order to meet customer orders/demands (e.g. JIT) Supported by an information system that permits access to production information at key stages of the process and is order driven Planning information during production scheduling includes relevant information, e.g., customer orders, supplier on-time delivery performance, 74 capacity, shared loading, lead time, inventory level,

75 Section : Identification and traceability supplemental Purpose of traceability is to support identification of clear start and stop points for product received by the customer (quality / safety-related issues) Conduct an analysis of internal, customer, and regulatory traceability requirements developing and documenting traceability plans based on risk or failure severity 75

76 Section : Identification and traceability supplemental Defined Plans: (Enable / Ensure) 76 Identification of nonconforming and/or suspect product; Segregation of nonconforming and/or suspect product; Ability to meet the customer and/or regulatory response time requirements; Records are retained in the format that enables the organization to meet the response time requirements; Serialized identification of individual products, if specified by the customer or regulatory standards;

77 Section : Preservation supplemental Includes identification, handling, contamination control, packaging, storage, transmission or transportation, and protection Apply to materials and components from external and/or internal providers Receipt through processing, until delivery to/acceptance by the customer 77

78 Section : Preservation supplemental Assess at appropriate planned intervals the condition of product in stock, the place/type of storage container, and the storage environment FIFO inventory Obsolete product controlled similar to nonconforming product Comply with requirements provided by customers 78

79 Section : Feedback of information from service Process for communication of information on service concerns to manufacturing, material handling, logistics, engineering, and design 79

80 Section : Service agreement with customer When there is a service agreement with the customer, the organization shall: Verify that the relevant service centers comply with applicable requirements; Verify the effectiveness of any special purpose tools or measurement equipment; Ensure that all service personnel are trained in applicable requirements. 80

81 Section : Control of changes supplemental Documented process to control and react to changes that impact product realization Effects of any change, must be addressed, and 81 shall: Define verification and validation activities to ensure compliance with customer requirements; Validate changes before implementation; Document the evidence of related risk analysis; (e.g. FMEA)

82 Section : Control of changes supplemental Changes (including suppliers), should require a production trial run for verification to validate the impact of any changes on the mfg. process. When required by the customer 82 Notify the customer of any planned product realization Obtain documented approval, prior to the change; Complete additional verification or identification requirements, such as production trial run and new product validation.

83 Section : Temporary change of process controls Identify, document, & maintain a list of the process controls, including inspection, measuring, test, & error-proofing devices, that includes the primary process control & the approved back-up or alternate methods. Document the process that manages the use of alternate control methods including approvals to be obtained prior to use of alternate control method 83 Before shipping, obtain approval from customer

84 Section : Temporary change of process controls (Continued) Work instruction for each alternate process control 84 method Review operation of alternate controls daily Return to standard process ASAP Methods may include daily audits, daily leadership meetings Restart verification is documented for a defined period

85 Section 8.6.1: Release of products and services supplemental Ensure that the planned arrangements to verify that the product & service requirements have been met, encompass the control plan, and are documented as specified in the control plan Planned arrangements for initial release of products & services encompass product or service approval. Ensure that product or service approval is 85 accomplished after changes following initial

86 Section 8.6.2: Layout inspection and functional testing A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review. Layout inspection is the complete measurement of all product dimensions on the design record. 86

87 Section 8.6.3: Appearance items For Appearance Items must provide: Appropriate resources, including lighting, for evaluation masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) & haptic technology, as appropriate maintenance and control of appearance masters and equipment Verification of competency of evaluating personnel 87

88 Section 8.6.4: Verification & acceptance of conformity of externally provided products & services Process to ensure the quality of externally provided processes, products, & services, using 1 or more: 88 Receipt and evaluation of statistical data provided by the supplier Receiving inspection and/or testing, such as sampling based on performance; Second-party or third-party assessments or audits of supplier sites when coupled with records of acceptable delivered product conformance to requirements;

89 Section 8.6.5: Statutory and regulatory conformity Prior to release of externally provided products into its production flow, Confirm (with evidence) that externally provided processes, products, & services conform to the latest applicable statutory, regulatory, & other requirements in: Countries where they are manufactured Customer-identified countries of destination, if provided. 89

90 Section : Customer authorization for concession Obtain a customer concession or deviation permit prior to further processing (product or mfg. process is different than approved) Customer authorization prior to further processing for "use as is" and rework dispositions of nonconforming product Includes notification of sub-component reuse Record of the expiration date or quantity 90

91 Section : Control of nonconforming product customer specified process Must comply with applicable customer-specified controls for nonconforming product 91

92 Section : Control of suspect product Must ensure that product with unidentified or suspect status is classified and controlled as nonconforming product. Must ensure that all appropriate manufacturing personnel receive training for containment of suspect and nonconforming product. 92

93 Section : Control of reworked product Must utilize risk analysis (such as FMEA) to assess risks in the rework process prior to rework Obtain approval, if required by customer, before 93 rework Documented process for rework confirmation reference the control plan Instructions for disassembly, rework, re-inspections & traceability requirements shall be accessible

94 Section : Control of repaired product Same as Reworked product, but for repaired product The organization shall obtain a documented customer authorization for concession for the product to be repaired. 94

95 Section : Customer notification The organization shall immediately notify the customer(s) in the event that nonconforming product has been shipped. Initial communication shall be followed with detailed documentation of the event. 95

96 Section : Nonconforming product disposition Documented process for disposition of nonconforming product not subject to rework or repair Must verify that the product to be scrapped is rendered unusable prior to disposal Must not divert nonconforming product to service or other use without prior customer approval 96

97 Section : Monitoring and measurement of manufacturing processes Perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability provide additional input for process control, including those for special characteristics Must maintain process capability or performance results per customer's PPAP requirements 97

98 Section : Monitoring and measurement of manufacturing processes Must verify that the process flow diagram, PFMEA, and control plan are implemented, including: 98 Measurement techniques; Sampling plans; Acceptance criteria; Records of actual measurement values and/or test results for variable data; Reaction plans and escalation process when acceptance criteria are not met.

99 Section : Identification of statistical tools Determine the appropriate use of statistical tools. Verify that appropriate statistical tools are included as part of the APQP process and included in: DFMEA (where applicable) PFMEA) Control plan 99

100 Section : Application of statistical concepts Employees involved in the collection, analysis, and management of statistical data must understand: Statistical concepts, such as variation, control (stability), process capability The consequences of over-adjustment 100

101 Section : Customer satisfaction supplemental Monitored through continual evaluation of internal & external performance indicators: 101 delivered part quality performance customer disruptions field returns, recalls, and warranty (where applicable) delivery schedule performance (including premium freight) customer notifications quality, delivery issues, special status

102 Section : Prioritization Must compare trends in quality and operational performance with progress toward objectives and lead to action to support prioritization of actions for improving customer satisfaction. 102

103 Section : Internal audit program Documented internal audit process, including internal audit program that covers the entire QMS: QMS audits, mfg. process audits, & product audits. Prioritized on risk, performance trends, criticality Software development capability assessments for SW Effectiveness of the audit program in Management Review 103

104 Section : Quality management system audit All QMS processes must be audited over each three-year period, according to an annual program Must use the process approach to verify compliance with IATF Must include sample of customer-specific QMS requirements for effective implementation 104

105 Section : Manufacturing process audit All manufacturing processes must be audited over each three-year period to determine their effectiveness and efficiency using customerspecific required approaches for process audits. If not defined by the customer, the organization determines the approach used. Each individual audit, each manufacturing process must be audited on all shifts where it occurs, 105 including the Copyright appropriate 2016 Management sampling Solutions Group, Inc. of the shift

106 Section : Product audit Must audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements. Where not defined by the customer, the organization defines the approach to be used. 106

107 Section : Management review supplemental Management review conducted at least annually. The frequency of management review must be increased based on risk to compliance with customer requirements resulting from internal or external changes impacting the quality management system performance-related issues 107

108 Section : Management review inputs Must Include: supplemental 108 cost of poor quality measures of process effectiveness measures of process efficiency product conformance assessments of mfg. feasibility made for changes to existing operations and for new facilities or new product customer satisfaction review of performance against maintenance objectives warranty performance review of customer scorecards (where applicable) identification of potential field failures identified through risk analysis (FMEA) actual field failures and their impact on safety or the env.

109 Section : Management review outputs supplemental Top management must document and implement an action plan when customer performance targets are not met. 109

110 Section : Problem solving Documented process for problem solving including: 110 Defined approaches for various types and scale of problems Containment, interim actions, and related activities necessary for control of nonconforming outputs Root cause analysis, methodology used, analysis, and results Implementation of systemic corrective actions, including CAR impact on similar processes and products;

111 Section : Error-proofing Documented process to determine the use of appropriate error-proofing methodologies Details of methods documented in the PFMEA (or equivalent) - test frequencies in the control plan Testing of error-proofing devices for failure or simulated failure. Records must be retained Challenge parts shall be identified, controlled verified and calibrated 111

112 Section : Warranty management systems Where warranty is required for their products: Implement a warranty management process. The organization shall include in the process a Method for warranty part analysis, including NTF (no trouble found) must be included. 112

113 Section : Customer complaints and field failure test analysis Perform analysis on customer complaints & field failures, including any returned parts Initiate problem solving & corrective action to prevent recurrence Include analysis of the interaction of embedded software of the product within the system of the final product Communicate the results of testing/analysis to the 113

114 Section : Continual improvement supplemental Documented process for continual improvement: Identification of the methodology used, objectives, measurement, effectiveness, & documented information A mfg. process improvement action plan emphasizing the reduction of process variation and waste risk analysis (such as FMEA) 114

115 Thoughts for us to consider Additional thought or concerns? What are the current activities at your organization that may meet the requirements? What changes in the new version may add value or improvements to your current business practices? 115

116 Next Steps & Closing 116