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ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
ISO/TS 16949 Rules 4th edition training
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ISO/TS 16949 Rules 4th edition training

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In this presentation, Charles highlights the changes to the TS16949 Rules Document and the affect on the certificate holders. The presentation is followed by a very informative FAQ session which can …

In this presentation, Charles highlights the changes to the TS16949 Rules Document and the affect on the certificate holders. The presentation is followed by a very informative FAQ session which can be found at the end of the ISO/TS 16949 webinar here - http://ul-dqsusa.com/information-center/recorded-webinars/amendment-isots-164949-rules-document-4th-edition-training/

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  • 1. Amendment ISO/TS - Rules 4th Edition Charles Blair Automotive Program Manager US & CN January 3 2014 DQS –UL Group
  • 2. Questions Please save any questions to the end of the presentation. I will address any questions or concerns you may have as soon as possible. Charles Blair, Charles.E.Blair@us.dqs-ul.com I will not be able to offer any suggestions on implementation plans or consult in any way. I will be able to answer any Accreditation concerns and how the new Rules may affect your organization Each Client is responsible to have a copy of the R4 document DQS –UL Group
  • 3. Section 1.0 – Eligibility for Certification to ISO/TS 16949 Foreword and Introduction DQS –UL Group • Public information about the validity of IATF recognized certificates can be found at www.iatfglobaloversight.org. • ISO/TS 16949 defines the quality management system requirements for a client providing design and development, production and, when relevant, assembly, installation, and services (see the definition of “Manufacturing” for the list of services) of automotive-related products.
  • 4. Background While UL-DQS certified clients are required to meet the TS16949 Specification, certification bodies like UL-DQS are required to meet the rules. The TS Rules govern certificates, contracts between certification bodies and suppliers, audit length, timing and conduct, and auditor qualification. The new rules go into effect April 1, 2014. DQS –UL Group
  • 5. Why change the rules? Changes to the rules are geared mainly toward changing the behavior of certification bodies to ensure that all automotive suppliers worldwide are held to the same high standards. DQS –UL Group
  • 6. What should I expect? Clients can expect impact on the following: • Audit Preparation • Audit Conduct • Nonconformity Management • Certificate Content and Certification Structure DQS –UL Group
  • 7. Audit Preparation The following are required to be provided to the lead auditor in advance of the audit: • The clients quality management system documentation, including evidence about conformity to the ISO/TS16949 requirements and showing linkages to any remote support locations and or outsourced processes (Typical evidence is the quality manual) • Customer and internal performance data since the previous audit. • Customer satisfaction and complaint summary since the last audit • Identification of any customer special status condition since the previous audit (i.e. Q1 Probation or revocation, CS1 or CS2, New Business Hold) • Notification of any new customers since the last audit • Results of internal audits. We now have a new form we will be asking you to help us complete. DQS –UL Group
  • 8. Audit Conduct In addition to completing our new form, you can expect a one hour meeting before the opening meeting to ensure that any changes since the audit plan was prepared are accounted for in the audit plan. DQS –UL Group
  • 9. Audit Conduct – Expect More Focus Here More focus on tracking customer complaints through to updates in control plans, FMEA’s and auditor evaluation of effective implementation For all processes assessed the auditors will need to document in the report a summary of the process performance against targets and action plans where targets are not met. Tip: To ensure a smooth audit – make sure all of your process owners are prepared to talk about their measures, goals and action plans. Auditing of shift transition and overlap Focus on ensuring all processes are covered on all shifts during the three year cycle – all audits will continue to cover all shifts – but now coverage across the processes must also be tracked. DQS –UL Group
  • 10. Nonconformity Management Any rewritten minor nonconformity will become a major nonconformity and a major nonconformity will be written against the corrective action process. Tip – Verify your prior audit nonconformities yourselves thoroughly before the next audit. DQS –UL Group
  • 11. Details on the changes Copies of the TS rules can be purchased from aiag.org. The following slides provide more details on the changes. DQS –UL Group
  • 12. Section 1.0 – Eligibility for Certification to ISO/TS 16949 Client Customer-specified production parts • The entire entity (including all related manufacturing sites and remote supporting locations) applying for ISO/TS 16949 certification. • ISO/TS 16949 is applicable to all sites of a client where customerspecified production parts and/or service parts are manufactured. • Parts that are an integral part of a vehicle. The only customerspecified parts that do not meet this requirement but are to be included are the following: fire extinguisher, car jacks, and floor mats. Manufacturing • The process of making or fabricating production materials, production of service parts, assemblies, or heat treating, welding, painting, plating, or other finishing services of automotive-related parts” (see ISO/TS 16949, section 3.1). DQS –UL Group Site • The location at which value-added manufacturing processes occur (see ISO/TS 16949, section 3.1). Fabless sites are not eligible for ISO/TS 16949 certification (see section 10.0).
  • 13. Section 1.0 – Eligibility for Certification to ISO/TS 16949 Service parts • Replacement parts manufactured to OEM specifications that are procured or released by the OEM for service-part applications including remanufactured parts. Aftermarket parts • Replacement parts not procured or released by the OEM for service part applications that may or may not be produced to original equipment specifications. Sites manufacturing only aftermarket parts are not eligible for ISO/TS 16949 certification. Supporting function • An onsite or remote facility at which non-production processes occur and that supports one or more manufacturing site(s) of the same client. DQS –UL Group Automotive • Includes the following: Passenger Cars, Light Commercial Vehicles, Heavy Trucks, Buses, Motorcycles, and to exclude the following: Industrial, Agricultural, Off-Highway (Mining, Forestry, Construction, etc.). Aftermarket parts are excluded.
  • 14. Section 1.0 – Eligibility for Certification to ISO/TS 16949 “Subscribing customer” is no longer used in the IATF Rules but replaced by “automotive customer.” When determining product design responsibility, the certification body shall allow two options: • The scope of ISO/TS 16949 audits/ certification shall include all manufacturing and all ISO/TS 16949 requirements. • Even if an automotive customer of the client – whether subscribing to ISO/TS 16949 or not – does not specifically require e.g. control plans or FMEAs, the certified client has to implement the requirements of ISO/TS 16949. This is the standard and the requirements the client is certified to. • 1) Client responsibility, including outsourced design, or • 2) Customer responsibility. • If the client provides evidence that it is not design responsible, the certification body shall exclude ISO/TS 16949, 7.3 Product Design from the client’s audit scope DQS –UL Group
  • 15. Section 1.0 – Eligibility for Certification to ISO/TS 16949 Site Extensions Site extensions as defined previously in CB Communiqué 2008-002 will no longer exist as part of the ISO/TS 16949 Certification Scheme. Existing manufacturing site extensions will need to transition to a single site between April 1, 2014 and April 1, 2015 using the process described in CB Communiqué 2013-006. IATF will withdraw, and make obsolete, the current possibility to include site extensions effective April 1, 2014. Clients with current Site Extensions should direct ?’s to Hoss Parandeh, VP of Sales & Marketing •Hoss.Parandeh@us.dqsul.com •Office 847-279-3336 •Cell 847-502-1521 DQS –UL Group
  • 16. 3.0 – Certification body contract requirements with the client Summary of the changes: 3.1 d) and e) Changed the requirement from “shall authorize …” to “cannot refuse” The contract between the certification body and the client shall address the following items: • d) the client cannot refuse the presence of an IATF representative or their delegates, • e) the client cannot refuse the request of the certification body to provide the final report to the IATF, Added in 3.1 that the audit team shall be knowledgeable in the legally enforceable agreement with the client Added in 3.2 the failure by the client to inform the certification body of a change may result in withdrawal of the client’s ISO/TS 16949 certificate DQS –UL Group These statements shall clearly appear in the contract with the client. Therefore, all contracts shall be updated with the new wording.
  • 17. 3.0 – Certification body contract requirements with the client The contract between the certification body and the client shall address the following items: g) consultants to the client cannot be physically present at the client's site during the audit or participate in the audit in any way. • Reason for the change: SI1 of Rules 3rd edition has been reworded to make clear that consultant cannot physically participate to the audit, but also in any other way, using technology such as: • videoconference, • e-mails, • sms … Failure by the client to inform the certification body of a change is considered a breach of the legally enforceable agreement and may result in the withdrawal of the client's ISO/TS 16949 certificate by the certification body. • Reason for the change: Stronger requirement to allow the certification bodies to take punitive action if the client fails to notify the certification body of an important change. DQS –UL Group
  • 18. 5.1 – Audit and Certificate cycle Summary of the changes: Clarified the target date for scheduling of recertification audits to ensure all certification bodies and Oversight offices have the same understanding. The consequences are now clear for not scheduling and conducting the recertification audit within the timing requirements (-3 months / +0 days). Added the requirement “recertification decision shall be made before expiration of the existing certificate” from Figure 5.1 into section 5.1.2 - Certificate cycle. This now makes the requirement clear for the certification body and the client. The last day of the first recertification audit shall not exceed three (3) years (-3 months / +0 days) from the last day of the initial stage 2 audit. If timing is exceeded, the client shall start over with an initial certification audit. The last day of the subsequent recertification audit shall not exceed three (3) years (-3 months / +0 days) from the last day of the previous recertification audit. If timing is exceeded, the client shall start over with an initial certification audit. DQS –UL Group • Even if the closing meeting target date for the recertification audit falls on a weekend or during a holiday
  • 19. 5.2 – Audit day determination In determining the number of audit days… An audit day is typically a full normal working day of 8 hours. A half of an audit day is typically a working day of four (4) hours. Each audit shall include auditing on all shifts • An exception to the eight (8) hour working day is when third shift work is being covered – see section 5.2 b). • An exception to the eight (8) hour working day is on Day 1 when the audit day shall be nine (9) hours. Section 5.7.2 a) requires the auditor to schedule a minimum of 1 hour to verify changes at the client’s site. The hour is in addition to the normal 8 hour day. • Expect a later start time for Audits to cover a 2nd shift operation. • 5.8 n). Multiple shift patterns shall be audited at each audit. • The minimum audit time in manufacturing shall be a minimum of one-third of the total audit days. • For 1.5 audit days (equal to 12 hours), the minimum amount of time auditing manufacturing should be 4 hours. DQS –UL Group
  • 20. 5.2 – Audit day determination Split Employee Count Section 5.2 (h): if a portion of the site is dedicated to automotive, then the headcount from that portion can be used to determine audit time when the following conditions are met: • approval from the relevant Oversight office is received prior to implementation, • all automotive manufacturing processes are physically separated from nonautomotive manufacturing (e.g. separate building, permanent barrier in between auto and non-automotive lines/machines, etc.), • personnel working in the automotive manufacturing process areas are completely dedicated, • all support activity personnel are included in the headcount, • Note: If automotive mfg processes are integrated on the manufacturing floor with non-automotive mfg processes, then this requirement cannot be applied. DQS –UL Group
  • 21. 5.2 – Audit day determination Split Employee Count: If client meets 5.2 h) then Certification body shall submit the “IATF Audit Day Reduction” application form and a waiver form to the appropriate Oversight office for approval PRIOR to implementing the reduced headcount for audit day calculation purposes. DQS –UL Group • No grandfathering is allowed. Previously approved sites will have to resubmit new paperwork. • Copy of the IATF Audit Day Reduction application form shall be made available to the auditor during audit planning to ensure the approved conditions are still met. • Auditors are required per 5.10 l) to include a written summary validating that the current conditions in the approved IATF Audit Day Reduction application form are still in place.
  • 22. 5.2 – Audit day determination When a client’s scope changes…when do you go on site for a special audit vs. waiting for the next audit? It depends upon how much has changed (e.g. management, people, processes, quality management system, etc.). It depends on when you were notified of the change by the client (e.g. 2 months before the next audit or 10 months before the next audit?). If the next audit is less than six (6) months from date of notification, review the changes at the next scheduled audit. If the next audit is greater than six (6) months, then conduct a special audit (see Rules 7.2). DQS –UL Group
  • 23. 5.5 – Remote support location In situations where remote supporting functions support many sites and these sites are audited by more than one certification body, the client has two options: Option 1: Each certification body audits the same remote supporting location(s). Option 2: A certification body may accept the audit by another certification body of the remote supporting locations subject to the following conditions being met prior to each audit. 1. The audit covered the complete product scope of those functions, consistent with the process-based audit approach, 2. The report given to the client by the CB who audits the remote support location has to identify the scope that was covered, describe the interfaces that were audited, and list the manufacturing sites it supports (see section 5.10) DQS –UL Group
  • 24. 5.5 – Remote support location Option 2 - Continued 3) The client provides…, prior to the site audit, a copy of audit plan, audit report, all findings, all corrective actions, & all verification actions by the other CB. DQS –UL Group • The CB (or their lead auditor)receiving the report has to be able to read or translate the documents to confirm the audit covered the scope of the functions supporting this site (see item 2) and to confirm the interfaces were audited (see item 4). • It is not acceptable just to store the documents created by the other CB or to accept information in a language that cannot be understood by the CB. • The Remote Location documentation must be in a language understood by the auditor.
  • 25. 5.5 – Remote support location Option 2 - Continued 4) The information (in the audit report) confirms that all the interfaces between the remotes supporting location and the site were audited… • Note: Deleted from Rules 3rd edition words “…during the stage 1 readiness review…” 5) Verification of the client’s corrective actions was conducted by the CB that audited the remote supporting location. Copies of all onsite verification activities reports shall be provided by the client to the CB. When any of the conditions cannot be met (items 1-5), the CB shall notify the client and go back to Option 1. DQS –UL Group
  • 26. 5.7.1 – Audit planning (Client) The certification body shall have a process to ensure that audit planning is completed prior to the start of the onsite audit. • a) the client’s quality management system documentation, including evidence about conformity to ISO/TS 16949 requirements and showing the linkages and interfaces to any remote support functions and/or outsourced processes. • Process map and/or quality manual has to clearly identify the linkage to remote support location and outsourced processes or the auditor shall write a nonconformance! • A Current Organizational Process Map will be required by the next scheduled Audit including detailed references to remote functions as well as an outsourced processes. DQS –UL Group Audit planning is a very critical step in the audit process and is very important to the IATF.
  • 27. 5.7.1 – Audit planning (Client) The client shall provide … Customer and internal performance data since the previous audit, Customer satisfaction and complaint summary since the previous audit, including a copy of the latest customer reports and/or scorecards, Identification of any customer special status condition since the previous audit, Notification about any new customers since the previous audit, Results of internal audits and management review since the previous audit. Note: For recertification audits, the information provided by the client (section 5.7.1, items b) – f) shall be collected for the period of certification (i.e. 3 years) and analyzed prior to developing the audit plan (see section 6.8.1 – Recertification audit activities). DQS –UL Group
  • 28. 5.7.2 – Audit plan The certification body shall undertake an analysis of the required information provided by the client to determine critical areas to be prioritized based upon risk to the customer, performance trends, and criticality of the process(es). b • Includes a review of the client’s website to validate the information provided (i.e. organization structure, customer, support activities, scope of certification, use of the IATF logo, etc.). A summary of the client’s performance, the result of the analysis, and identified priorities shall be recorded and retained as part of the audit record (see Annex 3) as minimum content. DQS –UL Group
  • 29. 5.7.2 – Audit plan The content of the audit plan ( Agenda ) shall… Identify the name of client’s processes to be audited. • Each activity in the plan shall reference the client’s process name and/or number • Generic activity names can be used, as long as, the client’s process(es) name(s) or number(s) are identified Identify when the interactions with remote support functions will be audited. • Example: Purchasing (client’s process AE 192) – including remote support interactions with Korea Where all of the required information in 5.7.1 a – f is not provided by the client prior to audit plan issuance, time shall be allocated to collect & review the missing information prior to the start of the opening meeting w/ the site management team or the decertification process shall be initiated (see section 8.1 g). • Can be included as part of the one (1) hour for verification of changes. DQS –UL Group
  • 30. 5.8 – Conducting on site audit Each onsite audit shall include the assessing and evaluating … • Review of IATF OEM customer performance reports online is covered during the verification of changes prior to the opening meeting (5.7.2 a). • Customer complaints and client’s responses for all customers is reviewed in detail during the appropriate process activity on the agenda. Prioritize the IATF OEMs. • Auditors need to take good notes, the final audit report requires a written summary of client’s performance to IATF OEM customers and information on actions implemented when performance was not met ( 5.10 e). • The client’s process for gathering, communicating, and implementing customer-specific requirements. Priority shall be given to IATF OEM members. DQS –UL Group Customer complaints and the client’s responses (for recertification see section 6.8), including a review of the applicable IATF OEM customer performance reports online.
  • 31. 5.8 – Conducting on site audit Each onsite audit shall include the assessing and evaluating … All shifts where it occurs, including an appropriate sample of the shift changeover. DQS –UL Group • For the stage 2, recertification, and transfer audits, all manufacturing processes shall be audited on each shift. Sampling of shifts and processes is not allowed. • At the subsequent surveillance audit cycle, all manufacturing processes shall be audited on each shift
  • 32. Auditing on all shifts Initial, Recertification, or Transfer Audit Example  On each of the 3 shifts, each of the manufacturing processes were audited. The auditor recorded the line or machine audited in each process on each shift. DQS –UL Group
  • 33. Auditing on all shifts Surveillance Audit Example  As you can see, all manufacturing processes were audited at the annual surveillance audit, but not every process was audited on every shift. DQS –UL Group
  • 34. Auditing on all shifts The Audit Team Has to: Audit all manufacturing processes (Stamping, Welding, Heat Treatment, Painting & Assembly) and all shifts Include inputs from the review of internal and external performance data to make decisions on where to go and which lines/machines are a priority. Decide how “deep” to audit a certain machine, workstation, line, etc. in each of the manufacturing processes. Decide based on experience whether to go back to the same line/machine on another shift to verify what was learned on current shift or to audit a different line/machine on the next shift. DQS –UL Group
  • 35. 5.9 – Audit findings Reason for the change: Observation and feedback through Office Assessments, Witness Audits, and IATF OEMs has shown us that: DQS –UL Group • The level of detail in the objective evidence in many cases is insufficient or poorly written to enable anyone (other than the auditor) to really determine the categorization of nonconformity. • Too many times witness auditors observe a closing meeting where the managing director accepts the 4 majors and numerous minor nonconformities, then turns to the witness auditor and states the only reason the auditor raised them “this time” was because he/she was being witnessed.
  • 36. 5.9 – Audit findings Reason for the change:  The level of nonconformities written at witnessed audits vs non-witnessed audits are significantly different - average of 8 per audit compared to 2.74, - 17% major compared to 4%, and - 1% audits with zero NCs raised compared to 16%. This does not provide Value & Credibility to the CB’s, auditor, client, IATF OEM or the scheme.  6 nc / audit 5 4 3 2 1 0 China Korea India USA Germany Japan Thailand Mexico Brazil Italy DQS –UL Group 16% 14% 12% 10% 8% 6% 4% 2% 0%
  • 37. 5.9 – Audit findings Summary of the changes:    Additional requirements regarding objective evidence content. Clarification regarding the impact of terminating audits due to major nonconformities. IATF is questioning if the # of audits with zero NCR’s is an indicator of soft grading or are the clients really that good? 45% Percent of Audits with Zero Nonconformances 39% 40% 35% 31% 30% 27% 25% 22% 20% 20% 18% 15% 19% 15% 15% 10% 7% 5% China Korea India USA Germany Japan Thailand Mexico Brazil Italy DQS –UL Group 0%
  • 38. 5.9 – Audit findings Example of Major NCR with quantifiable data The additional objective evidence provided now lets the auditor make a justified categorization. Other people reading the nonconformity (i.e. veto powers) can also more readily understand the justification of the categorization. Nonconformity: The gauge calibration system is not fully effective. Requirement: ISO/TS 16949:, 7.6(a) states that “… measurement equipment shall be calibrated or verified at specified intervals …” Objective Evidence: Gage XF 102, a digital caliper, being used in work cell 4 was found out of calibration (over due by 3 months). 9 other gauges were checked and found to be in calibration. The product is not tested after work cell 4 prior to delivery to the customer DQS –UL Group
  • 39. 5.10 – Writing the audit report Summary of the changes: Written audit reports • Required for each site and remote support locations. • Closing meeting report required with NCR’s, OFI’s & recommendation • Final Report within 15 days • Requires client signature or written acknowledgement of receipt New content for the audit report – see 5.10 DQS –UL Group • b) total number of employees on site, • c) list of all automotive customers • e) summary of client‘s performance to IATF OEM • g) completion of Annex 1.2 table for manufacturing processes on all shifts • k) descibing the interactions with remote support locations • l) validation of the current employees dedicated to automotive conditions (5.2 h) • n) copy of final audit plan.
  • 40. 5.10 – Writing the audit report The final audit report shall …contain the following information: List of all automotive customers whose requirements were audited during audit cycle. • Required to keep a running history over the 3 year period of which automotive customer requirements were audited. List of all automotive customers and, if applicable, the latest date of their CSR’s. • List all automotive customer names (OEMs, tier 1, tier 2, tier 3, etc.). • If the customer does not have CSR’s – show it as “Not Applicable”. Summary of client’s performance (i.e. product quality, delivery, and special status) to IATF OEM customers & info on actions implemented when performance not met. • Often IATF OEMs have read CB audit reports for their problem suppliers and find little detail in the reports explaining the client’s performance or what actions (and effectiveness of actions) have been taken by the client when performance was not meeting their expectations. • Paragraph(s), not a single sentence or a single statement DQS –UL Group
  • 41. 5.10 – Writing the audit report The final audit report shall …contain the following information: Summary of audited processes (see table in Annex 1.1). …and written information on the performance of each process audited. DQS –UL Group • Complete Annex 1.1. Renumbered from Rules 3rd edition • For each of the client’s processes…auditor needs to provide written information on the objectives, targets planned for the year, and current status of the client’s performance and what was investigated when performance did not reach the targets and if any nonconformities were issued against the process. • The expectation is that each process have a defined goal and the summary have details on the progress of the goal and specific actions taken if the goal has not been met • This list of processes should align to the processes in the audit plan (see 5.7.2).
  • 42. 5.10 – Writing the audit report The final audit report shall…contain the following information: If a remote support location is included as part of this (site audit) report, the report shall include their address, their function(s), a list of sites it supports, and a written description of the interactions that were audited for the support location. DQS –UL Group • Functions listed for the remote support location (e.g. purchasing, warehousing, management, etc.) shall match the list of functions in the IATF DB – see section 5.13 of this presentation for the current list.
  • 43. Observation and feedback through Office & Witness Audits indicated the process was inconsistently applied. IATF believes in may cases this had led to ineffective nonconformity management by both clients & CB’s, i.e. major nonconformities 100% resolved, no onsite followup prior, 100% resolved has been adopted as the standard approach for all nonconformities by some CB’s. Introduction of client responsibilities including submission timing requirements of 60 calendar days. Redefined CB responsibilities. Introduction of impact of failure to close within 90 calendar days. Clarification regarding the use of 100% resolved. Mandatory onsite verification for major nonconformities and related requirements. DQS –UL Group The requirements needed further enhancement to drive the right process and achieve the benefits of effective problem solving through nonconformity management. Summary of the changes Reason for the change: 5.11 – NC management
  • 44. 5.11.2 CB Responsibility CB shall require client to submit within 60 calendar days of the closing meeting of the site audit, evidence of the following: • implemented correction, • root cause including methodology used, analysis, and results, • implemented systemic corrective actions to eliminate each nonconformity, including consideration of the impact to other similar processes and products, • verification of effectiveness of implemented corrective actions. CB shall review the submitted information and make a decision regarding acceptability within a maximum of ninety (90) calendar days from the closing meeting of the site audit. If found acceptable, the nonconformity shall be closed and the CB shall verify effective implementation of the identified corrective actions at the next audit Note: Next audit is understood to be the next scheduled audit (surveillance or recertification). DQS –UL Group
  • 45. 5.11.2 - CB responsibility If found not acceptable • The CB shall resolve the outstanding issues with the client within a maximum of ninety (90) calendar days from the closing meeting of the audit. • If resolution cannot be completed, the final audit result shall be considered failed and the IATF database shall be updated. The certification decision shall be negative and the client shall start over with an initial certification audit. • The current valid certificate shall be immediately withdrawn 5.11.2 - 100% resolved: In exceptional case(s) where the implementation of corrective actions cannot be completed within a maximum of ninety (90) calendar days from the closing meeting of the site audit, the CB shall consider the nonconformity open but 100% resolved. The expectation is that if it takes more than 90 days to resolve, why was the Finding not identified as a Major Nonconformance. DQS –UL Group
  • 46. 5.11.1 – Nonconformity Management Exceptional Case Examples: Allowed Where the Corrective Action includes: A new piece of equipment (machine, testing or handling equipment) is required and the lead time for delivery / installation is more than 90 days. A new IT system is required and the delivery / installation is more than 90 days. Building of a new facility has been identified i.e. warehouse and the build phase is more than 90 days. A problem is found with information on drawings or specifications and maybe the company has 2000 to update. It may not be practical to update all within the 90 days. In this case we would look for good containment and a plan for updating (maybe it will be updated when the drawing/spec is next used in production), but this could take for example 1 year to complete. A problem is found in a design process, where the process/procedure may be updated, but evidence of full implementation may not be until the next project is instigated, which could be more than 90 days. DQS –UL Group
  • 47. 5.11.2 - 100% resolved Conditions for allowing a) containment of the condition to prevent risk to the customer has been taken, including a review of the systemic impact on the client’s process, b) documented evidence of an acceptable action plan, instructions, and records to demonstrate the elimination of the nonconformity condition, including a review of the systemic impact on the client’s process, c) scheduled onsite follow-up audit based on the accepted action plan and prior to the next audit, (Note this is an additional audit before the next scheduled surveillance or recertification audit) d) in situations where 100% resolution has been determined, the CB shall maintain records of the justification. DQS –UL Group
  • 48. 5.11.3 - Onsite verification A major nonconformity shall require onsite verification of the corrective action within a maximum of 90 calendar days from the closing meeting of the site audit. If the accepted corrective action plan for a major nonconformity is found not effectively implemented, the audit result shall be considered failed, the IATF database shall be updated, and the certificate withdrawn (see 8.4) Onsite verification of the corrective action for a minor nonconformity within a maximum of 90 calendar days from the closing meeting of the site audit is at the discretion of the CB based on knowledge & experience. If the accepted corrective action plan for a minor nonconformity is found not effectively implemented, a new major nonconformity shall be issued against the corrective action process (TS 8.5.2) & the previous minor nonconformity reissued as a major nonconformity. Immediate Suspension is initiated. CB shall issue a supplemental report to the client after verification of corrective action is complete, which shall include the verification details of each nonconformity. DQS –UL Group
  • 49. 5.13 – Certificate issuance The content of the certificate shall… • b) include only all design and manufacturing activities for automotive-related products and services meeting the applicability of ISO/TS 16949 To ensure consistency, certificate scope statements shall be stated as: • “design and manufacturing of widgets”, • “manufacturing of widgets” or “manufacturer of widgets” • “assembly, heat treat, welding, plating, painting, etc. of widgets” • Shall not include: For the auto industry, Development, Sales, Engineering, Servicing, Warehousing, Sequencing, etc. DQS –UL Group
  • 50. 5.13 – Certificate issuance The content of the certificate shall ... Include in the appendix the remote supporting functions that are part of the quality management system and have been audited. DQS –UL Group • Remote support location will no longer be allowed on the front page of certificate. Has to be included in an appendix. • Complete address and functions • The functions shall match the list identified in the IATF database. No longer use the function names provided, or requested, by the client. • If a remote supporting function supports more than one site, it shall appear on each site certificate.
  • 51. Current List of Support Functions from IATF DB DQS –UL Group
  • 52. 5.13 – Certificate issuance The content of the certificate shall… k) Include the IATF logo in equal prominence with the certification body logo on each certificate page. Client logos are not permitted on the certificate. l) Not include CB membership logos on the certificate (e.g. IQ NET, etc.). o) Not reference other standards for which the CB is not recognized by IATF (i.e. ISO 9001). o) Existing certificates bearing the client logos, CB membership logos, site extensions, or with support functions names that do not match the IATF Database list have to be updated between 1 April 2014 – 1 April 2015. DQS –UL Group
  • 53. Questions ? DQS –UL Group

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