Fisher_DeGarmo_Reiche_Gray-IATF-16949-Panel-Discussion-CHS-Aug-25-v3-C.ppt

IATF 16949:2016 Update and Automotive QMS Transition Success,SCAC/AIAG Supply Chain & Quality Conference August 25, 2017,IATF 16949 Success Panel,SCAC/AIAG Supply Chain & Quality Conference August 25, 2017,Cherie ReicheIAOB Program Manager,Scott Gray AIAG Director Quality,Bob DeGarmoGeneral Motors BIQS,Cathy Fisher Panel ModeratorQuistem, LLC,Session Agenda,IATF 16949:2016 OverviewCustomer-specific Requirements and IATF 16949IATF 16949 Transition Audit UpdateTop 8 IATF 16949 Transition Audit NonconformitiesCommon Questions about transitioning your Automotive QMS to IATF 16949Your Questions AnsweredNext Steps,SCAC/AIAG Supply Chain & Quality Conference August 25, 2017,IATF 16949:2016 Overview,SCAC/AIAG Supply Chain & Quality Conference August 25, 2017,Scott Gray AIAG Director Quality,Transitioning to IATF 16949:2016Scott Gray, AIAGAugust 25, 2017,Background on the Revision Project,Revision work began in December 2014 and was completed in August 2016The team completed a 5-Phase approach to develop IATF 16949Pre-plan; Analyze; Build; Validate; and DeployRevision Work Team consisted of 17 global partners from 14 organizations (IATF OEMs, National Associations, Oversight Offices),Unprecedented Stakeholder Input,IATF launched a survey (via the National Associations) early June 2015 soliciting feedback from over 2,000 key stakeholders:OEMsSuppliers (all Tiers)Certification BodiesWitness AuditorsSubject Matter ExpertsOversight OfficesOver 1,700 comments were received for considerationAdditionally, the IATF conducted a face to face review of the draft IATF 16949 standard in Rome, Italy in April 2016 with over 100 stakeholder representatives including CBs, suppliers, and witness auditors.Several hundred more comments were received for consideration,ISO/TS 16949 to IATF 16949,The new automotive standard: IATF 16949:2016 . . .Follows the high level structure of ISO 9001:2015,Check,Act,ISO/TS 16949 to IATF 16949,The new automotive standard: IATF 16949:2016 . . .Builds on the new areas of emphasis in ISO 9001:2015LeadershipCompetenceRisk-Based ThinkingMust be used in conjunction with ISO 9001:2015Two (2) documents must be used to have all requirementsIATF 16949 cannot be used as a stand-alone requirements document,Changes to Drive Value & Credibility,IATF members focused on the linkage between ISO/TS 16949 Certification and Supplier/Client quality performanceIncreased focus on operational performance and customer feedback (customer scorecards/metrics)IATF 16949 contains many former OEM Customer Specific Requirements (CSRs)Most of the changes occurred in areas where IATF OEMs observed weakness trends and systematic issues,IATF Transition Support,IATF 16949:2016 Resource CenterIATF and ISO StandardsRules 5thCore Tools and other CQIsIATF 16949 TrainingAuditor CertificationsGap Analysis Tool,IATF16949 Training Courses,Understanding IATF 16949:2016Transitioning to IATF 16949:2016Transitioning to IATF 16949:2016 for Automotive AuditorsIATF 16949 Understanding and Internal Quality AuditingExemplar Global Certified ISO9001:2015 Internal Auditor Training with Automotive EmphasisExemplar Global Certified ISO9001:2015 Lead Auditor Training with AIAG IATF 16949:2016 Supplier Auditor CertificationNew IATF 16949 Executive Understanding New Transitioning to IATF 16949 - eLearning,Questions?,Customer-specific Requirements and IATF 16949:2016,SCAC/AIAG Supply Chain & Quality Conference August 25, 2017,Bob DeGarmoGeneral Motors BIQS,IATF 16949 Roll-Out Meeting Robert DeGarmo GM IATF RepresentativeSCAC/AIAG Conference Charleston, SC August 25,Instructions to Suppliers,The need to transition to IATF 16949 has been affirmed by Gary West, General Motors Executive Director of Supplier Quality and DevelopmentThe letter was communicated to all GM Tier 1 Suppliers on November of 2016,Customer Specific Requirements,GM released the new CSR for IATF 16949 (80% reduction in content)ISO/TS 16949 CSR has also been updatedEach CSR contain requirements unique to the two standardsBoth documents will be maintained in sync during the transition periodBoth are available on IATF web site and on GM Supply Power,Changes to GM-CSR for IATF 16949, Customer satisfaction Supplemental.BIQS CertificationOrganizations shall achieve and maintain BIQS or QSB certification. The organization whose BIQS or QSB certification is revoked shall notify its Certification Body within 5 business days after revocation. Lack of the organization having a BIQS or QSB certification shall result in a major finding by the organizations Certification Body.CSII (Controlled Shipping Level 2)The organization shall notify its Certification Body within 5 business days after being placed in Controlled Shipping Level 2 (CS II) Status.NOTE: The GM special status conditions of CS II (Controlled Shipping Level 2) is a performance indicators of an organizations product realization problems. Such status should have resolution, or credible resolution and corrective plans in place, which are confirmed by the customer.,SUPPLIER CERTIFICATION MANAGEMENT SYSTEM (SCMS),NEED SLIDE(S),123456789 ABCD Supplier,New GM Sourcing Tool (replacing the old GM Bid-List),Key Points about Customer-specific Requirements (CSRs),May exist at any level in Automotive supply chain, (OEM, Tier 1, etc.)Identify CSRs for all your Automotive customersDetermine applicability of CSRs and align with your QMS processesInclude CSRs in Scope of our QMSInternal auditing of CSRs,SCAC/AIAG Supply Chain & Quality Conference August 25, 2017,IATF 16949 Transition Audit Update including Transition Audit Nonconformities,SCAC/AIAG Supply Chain & Quality Conference August 25, 2017,Cherie ReicheIAOB Program Manager,SCAC / AIAG IATF 16949:2016 Transition Audit Update,August 25, 2017Cherie Reiche, IAOB,Current Certificate Distribution (both standards),Distribution of the 68,654 certified sites as of 31st July 2017,(only countries with more than 500 certified sites listed),IATF 16949 - Progress,As of 31st July 2017:1,939 completed audits to IATF 16949As of 31st July, total NCs issued = 2,320,IATF 16949 - Progress,Top 8 non-conformity areas in order of frequency8.5.1 (ISO) Control of production and service provision Total productive maintenance Control plan Standardized work operator instructions and visual standards Special characteristics Contingency plans.1 Measurement systems analysis Manufacturing process design output,8.5.1 Control of Production & Serv,ISO 9001:2015 requirementProduction and service provision implemented under controlled conditionsIncludes documented information for:characteristics of the products produced, services provided, activities performed;results to be achieved;availability and use of suitable monitoring and measuring resources;,27,8.5.1 Control of Production & Serv,monitoring and measurement activities at appropriate stages (verify criteria for control of processes or outputs, and acceptance criteria for products and services)use of suitable infrastructure and environment for the operation of processes;appointment of competent persons, including any required qualification;,28,8.5.1 Control of Production & Serv,Validation of the ability to achieve planned results of the processes for production and service provisionImplementation of actions to prevent human errorImplementation of release, delivery and post-delivery activitiesAlso see IATF Standardized Work and Verification of Job Set-ups,29, TPM,Total productive maintenanceSystem for maintaining and improving the integrity of production and quality systems through machines, equipment, processes, and employees that adds value to the manufacturing process.TPM should be fully integrated within the manufacturing processes and any necessary support processes.Also see Management of production tooling ,30, Control Plan,Strengthened control plan requirementsBrought IATF OEM customer-specific requirements into the IATF 16949 standardElevated NOTE regarding customer approval to a requirementStrengthened control plan review and updated criteria and linked to the PFMEA updates. Control plans are needed for the relevant manufacturing site and all product supplied, and not just for the final product or final assembly line,31, Control Plan,Family control plans are acceptable for bulk material and similar parts using a common manufacturing processCare should be given to identify the degree of difference that is acceptable to apply common control,32, Standardized Work ,Operator instructions and visual standardsCommunicated / understood by the employees who perform the work (legible, in the language understood by personnel, accessible at the designated work areas),33, Special characteristics ,Established using multidisciplinary approach to identify special characteristicsRisk analysis performedDocumentation of all special characteristics:drawings, control plans, standard work / operator instructions (identify with specific markings)Control and monitoring strategiesCustomer-specified approvals, as requiredUse of symbol conversion table, submitted to customer as required,34, Contingency Plans,Prepare contingency plans along with a notification process to the customer or other interested parties.Organizations would first take a systematic approach to identifying and evaluating risk for all manufacturing processes, giving particular attention to external risk.,35, Contingency Plans,Contingency plans would be developed for any of the outlined disruption conditions - interruption of externally provided products, processes, and services, recurring natural disasters, fire, or infrastructure-related disruptions.Customer notification is a mandatory step in any contingency plan, unless there is no risk to deliver nonconforming product or affect on-time delivery.,36,.1 MSA,Conducted to analyse variation in results of each type of inspection, measurement, and test equipment system (per control plan)Analytical methods and acceptance criteria; alternative methods may be approved by customer (records of customer acceptance retained along with results of alternative MSA)MSA study prioritization should focus on critical or special product / process characteristics.Also see Section ,37, Mfg Proc. Design Output,Shall be verifiable against mfg process design inputsThis includes specs/drawings; special characteristics for product/mfg process; id of input variables; tooling and equipment for production and control, including capability studies of equipment and processes; mfg process flowcharts/layouts; capacity analysis;,38, Mfg Proc. Design Output,mfg process FMEA; maintenance plans/instructions; control plan; std wk/wk instructions; acceptance criteria approval; quality/reliability data; results of error proofing; rapid detection and correction of nonconformities,39,IATF 16949 - Progress,Top 8 non-conformity areas in order of frequency8.5.1 (ISO) Control of production and service provision Total productive maintenance Control plan Standardized work operator instructions and visual standards Special characteristics Contingency plans.1 Measurement systems analysis Manufacturing process design output,Common questions ,Must we use both ISO 9001:2015 and IATF 16949:2016 when conducting audits?ANSWER: Yes, as it states in the IATF 16949 Foreword Automotive QMS Standard, IATF 16949 is not a stand-alone standard, it must be used in conjunction with ISO 9001:2015,Common questions ,Will the IATF be granting waivers for those organizations who cannot meet the Transition Plan timing?ANSWER: No, from 1st October 2017 onward, all audits are required to be conducted to IATF 16949There are no plans to approve/grant waiversISO/TS 16949 certificates are not valid past their expiry or 14th September 2018, whichever occurs first.,Common questions ,What about competency for internal auditors and second-party auditors? Do they have to all take an IATF-sanctioned lead auditor training course?ANSWER: No. Organizations are responsible for ensuring key personnel, including their auditors, are properly trained and competent. The IATF supports the use of IATF-recognized training providers; however, the IATF does NOT mandate the use of a lead auditor training course for all auditors in the organization.Organizations are still allowed to have key personnel trained and certified as lead auditors, and then using those key personnel to T3 (train-the-trainer) to disseminate the information throughout the organization.,Common questions ,What is the goal of ? Do all organizations supplying automotive product have to be IATF 16949 certified?ANSWER: As stated in , the ultimate objective is to have IATF 16949 certification; however, the IATF recognizes that for various reasons, that is not feasible for all organizations.At a minimum, the expectation is for organi