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AmendmentISO/TS - Rules 4th Edition

Charles Blair

Automotive Program Manager US & CN

June 24 2014

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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 including the published Sanctioned Interpretations and Frequently asked Questions.

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Section 1.0 – Eligibility for Certification to ISO/TS 16949

Foreword and Introduction• Public information about the validity of IATF

recognized certificates and updates may be found at www.iatfglobaloversight.org.

• Questions sent to UL-DQS• Impact of a Major Nonconformance• IATF FAQ Update• Remote Locations• Organizational Process Maps

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Questions to UL-DQS

Q: Design Responsibility:Must this requirement extend to non-subscribing customers

(i.e. Toyota)?A: Yes. The entire manufacturing facility holds a TS Certificate.

Each OEM will be audited to their published Customer Requirements. It’s the responsibility of the Site to determine Customer requirements are determined and are met (TS 5.2 )

Q: If Overseas design group is starting at “ground zero” for TS compliance, what is needed by April 1? Is an action plan

targeting their first TS audit sufficient?A: All Support process will be audited to the Customer Specific requirements as they support the Manufacturing facility. The

next audit will be performed to TS requirements..

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Questions to UL-DQS

Q: Is it still allowable to not meet specific TS clause requirements (such as control plan) if a non-subscribing

automotive customer has requirements that differ from TS or if such customer provides a document waiving our need

to follow TS for a given clause?A: NO. With regards to control plan, a customer may not waive the need for a control plan. The control plan may

take a different form as long as it includes the proper content. Each process will be audited to the OEM specific

requirements as applicable. For example: a Ford product or process will be audited to the Ford requirements and a

Toyota process will be audited to the Toyota requirements. Remember, a customer can waive any part of their CSR, but

they may not waive any clause (or sub clause) in the TS Standard

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Questions to UL-DQS

Q: New rules include non-automotive products (forklift, lawn mowers, etc) in audit man-day head count unless

there is physical separation between the production lines (wall, different building, etc).

A: The new Rules again allow for a Spit Employee Count. The presentations are very specific about conditions and all require authorization from the IATF. There is a form to fill

out. Also, at every audit we must re-confirm that the approved condition still exists.

Q: Does this mean the processes involved in non-automotive products also have to meet TS requirements?

A: Yes. Plus, each process will be audited to the Customer’s requirements. Paccar or John Deere will be audited to the

published Customer requirements.

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Questions to UL-DQS

Q: Major Nonconformities:are to be issued for certain conditions, including:

Any noncompliance that would result in the probable shipment of nonconforming product.

Audits always include a review of customer claims and corrective actions taken to address those claims. These claims often but do not

always represent product received by the customer that is nonconforming, whether due to damage or other situations.

Q: Are we to expect auditors to issue Major nonconformities on a regular basis because customer claims provide evidence that

nonconforming product has been shipped?A: The Review of Customer Complaints will be for cause, correction / implementation and verification of effectiveness of the actions taken as a result of the complaint on the part of the Client. If a condition is

discovered during the audit that an out-of specification condition exists with no further verification, that would be an example of a

condition that would result in the probable shipment of nonconforming product.

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Questions to UL-DQS

Q: Rewritten Nonconformities:Rewritten nonconformities result in the issuance of 2 Major findings, 1

addressing the specific nonconformity and another addressing the failure of the corrective action system. Is there a time period

associated with identifying specific problem recurrence, i.e. within one year? Triennial cycle?

A: All previous nonconformities may come under review during an audit. The Recertification audit will include all previous

nonconformances identified during the last cycle. Q: Will auditors consider nonconformities as “rewritten” if a new

finding is similar or related to a previous finding, but is not exactly the same?

A: An example may be if a non-calibrated measurement device is discovered in one process area and another non-calibrated device is discovered in another area the next audit. This would indicate the

system for gage recall is not effective and may be considered a Major nonconformance. However, if you had the same initial finding above and then they had another finding in calibration, but it was for MSA,

then that would not be considered a repeat.

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Audit Preparation FAQ # 31 6/23/2014

The following are required to be provided to the lead auditor in advance of the audit:• The IATF´s expectation is that the client has to submit at least the following information to the certification

body as part of 5.7.1 a) and 5.7.1 f):• - documented statements of a quality policy and quality objectives• - a quality manual• - documented processes• - process map showing linkages and interactions of the processes• - documented linkages between processes and ISO/TS requirements• - summary of internal system, process and product audits conducted• since the last certification body audit, including a summary of• •• the total no. of nonconformities by audit type• •• the classification of each nonconformity and• •• the relevant requirement (audit criteria) as applicable• - management review output / action item list

We now have a new form we will be asking you to help us complete. The Lead Auditor will be sending in Form CF160.

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Audit Planning

Please make sure you answer all questions in the CF160 Form. If you have concerns, contact the Lead Auditor. If the planning information is not received, you may not

get an Agenda in a timely manner.

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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.

Audit planning is a very critical step in the

audit process and is very

important to the IATF.

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Manufacturing & Assembly

Process

Measurements• Scrap / Rework• Customer PPM• Production Efficiency• Sales Past Due

Input• Customer Requirements (Corporate)• Build Schedules• Plant Goals• Purchasing ( Corporate )• Print Requirements(Corporate)• Engineering Specifications(Corporate)

Controls• Operator Work Instructions• Poka-Yokes• Gauging• SPC• Process Sheets• Back-up Sheets

Output• Elimination of Waste (Overproduction, Idle Time, Over Processing, Excess Inventory, Scrap/Rework)• Improved Delivery, Quality, and Cost

Resources• Production Manager (Process Owner)• Production Supervisor • Quality Manager• Quality Engineers ( Site and Corporate )• Production Operators•Industrial Engineering ( Site and Corporate )• Suppliers• Process Engineers ( Site and Corporate )

Linkages: •ISO/TS16949 Section 7 - Product Realization•Internal Processes: 2.1 - Strategy Development; 2.2 - Strategy Deployment; 4.1 - Measurement and Analysis of Organizational Performance; 5.1 - Work Systems; 6.1 - Value Creation Process, 7.1 - Customer-Focused Results; 7.5 - Organizational Effectiveness Results•FORD CSR 4.9, 4.10, 4.13, 4.31, 4.34

Outsourced processes• Plating• Finishing•Painting

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Nonconformity Management

Any rewritten minor nonconformity will become a major nonconformity and a major nonconformity may

be written against the corrective action process.

Tip – Verify your prior audit nonconformities yourselves thoroughly before the next

audit.

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Nonconformity Management

Complaint fromIATF OEM CustomerIATF Oversight Office.Special Status (as examples):

GM: CS2, NBHFORD: Q1 RevocationCHRYSLER: Needs ImprovementVW: C DAIMLER: Q-Help, NBHFIAT: CLS2, NBHFailure to provide Planning information.

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5.11 – NC management Re

ason

for t

he c

hang

e: 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 follow-up prior, 100% resolved has been adopted as the standard approach for all nonconformities by some CB’s.The requirements needed further enhancement to drive the right process and achieve the benefits of effective problem solving through nonconformity management.

Sum

mar

y of

the

chan

ges 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.

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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).

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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.

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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.

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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.

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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

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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.

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Nonconformity Management

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Nonconformity ManagementNo. 1 of 1 Ref. No.

1. Finding to be filled in by Auditor

Standard Requirement(Reference)

Process/Area

Statement of nonconformity:

Requirement:

Objective evidence:

Reasons why the nonconformity was not classified as major nonconformity:

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Nonconformity ManagementNo. 1 of 1 Ref. No.

4. Root cause of nonconformitie(s) filled in by company

1.Why

2. Why

3. Why

4. Why

5. Why

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IATF FAQ 6.23.2014

# 5 Notice of changes by the client Q: 3.2 Should the audit team issue a major nonconformity to the client if the client fails to inform the CB of any changes?

A: Yes, failure by the client to inform the CB of a change to their legal, commercial, ownership, address, scope of operations, IATF customer special status or management system/process is considered as a breach of the legally enforceable agreement and a major nonconformity should be issued. This may result in the withdrawal of the client’s ISO/TS 16949 certificate by the CB.

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IATF FAQ 6.23.2014

# 8Onsite verification of corrective actions5.2 d)5.11.25.11.3Q: Is the onsite review of previous nonconformities only applicable to minor nonconformities?A: Yes, the onsite verification of previous nonconformities is additional to the specified audit days [5.2 d)] and is only applicable to minor nonconformities.For major nonconformities, onsite verification of corrective actions is completed within a maximum of 90 calendar days from the closing meeting date.For nonconformities open, but 100% resolved, onsite verification of corrective actions is completed based upon the accepted corrective action plan dates and prior to the next audit.NOTE: If there was an on-site visit to verify a Major nonconformance and the Minors were resolved at the same time, there’s no need to verify at the next Surveillance or add time after the 8 hour day.

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IATF FAQ 6.23.2014

# 14 Supporting activities

Q: 5.5 It is required that "additional audits of remote supporting functions may be necessary based on their demonstrated performance as seen at the site". However there is no requirement for the CB who audited the remote location to review the audit finding/results from the site-auditing-CB who may recommend additional audit of remote supporting functions. What is the site-auditing-CB´s obligation is this situation?

A: It will be up to the site-auditing-CB to have the client contact the remote-support-auditing-CB to make a request for additional follow-up. This would include sending the site-auditing-CB a copy of the site audit report and any nonconformity issued. If the remote auditing CB fails to implement their request, the site-auditing-CB needs to explain the client that they have to go back to Option 1.

NOTE: Option 1 is an on-site visit to the remote Location

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IATF FAQ 6.23.2014

# 15 Establishing the audit team Q: 5.6 Can a CB assign a different audit team member to conduct the on-site verification of nonconformities than the audit team member who conducted the original audit? If so, can this auditor be allowed to audit the client in the subsequent audit cycle?

A: The IATF´s expectation is that a member of the current audit team is to conduct the onsite special audit to verify previous nonconformities. If the CB assigns a different auditor to conduct the onsite special audit (which is also to be entered into the IATF Database), then this auditor would be considered part of the current audit team for this audit cycle and therefore is not eligible to participate in the subsequent audit cycle.

NOTE: In the case of travel expenses, a more local auditor may be used. However, the more local auditor will not be able to participate in the next audit Cycle.

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IATF FAQ 6.23.2014

# 17 Audit Plan Q: 5.7.2 Is the 1 hour minimum on site prior to the opening meeting applicable to audits at remote support functions?

A: If a remote support function is subject to external customer performance data which is being reported to the remote support function directly, then the minimum one hour verification of changes is required in the audit plan.

NOTE: Please provide your Lead Auditor with a description and , if applicable, Customers that provide scorecard information from the Customer. An example may be a warehouse that directly ships to an OEM. Another may be if a Corporate Function is scored by on-time PPAP Submission.

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IATF FAQ 6.23.2014

# 18 Audit Plan Q: 5.7.2 Assume the audit team has three auditors [A (lead), B & C]. While the lead auditor (A) is conducting the one hour onsite meeting to verify changes (per 5.7.2 a), can co-auditor (B) already verify previous audit minor nonconformities prior to opening meeting? A: Rules, section 5.7.2 does not require the entire audit team to be present at the 1 hour on site verification of changes meeting prior to the opening meeting of the audit. During the CB conference in November 2013, it was verbally recommended that co-auditors participating on Day 1 of the audit attend the 1 hour pre meeting, but it is not mandatory. The 1 hour meeting cannot be reduced by having more than 1 auditor participate in the meeting. NOTE: A co-auditor can conduct the verification of previous minor nonconformities during the same time the one hour onsite verification of changes meeting is occurring. This is another opportunity to verify previous nonconformities without adding time to the Agenda.

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IATF FAQ 6.23.2014

# 18 Audit Plan ( cont. )Q: And can co-auditor (C) audit the night shift (i.e. 3rd shift) production prior to opening meeting?

A: No member of the audit team can start any part of the audit prior to opening meeting.

NOTE: If there is a dedicated, non-rotating weekend shift and the Lead Auditor needs to start on a Saturday or Sunday, you still have to have a formal Opening Meeting prior to the start of the Audit.

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IATF FAQ 6.23.2014

# 24 Onsite Verification Q: 5.11.3 Are two onsite verification activities required when a major nonconformity is accepted as open, but 100% resolved (i.e. onsite within 90 days per 5.11.3 / 8.4 and onsite based on the date of the corrective action plan per 5.11.2.c)?

A: Yes, two onsite verifications are required. One onsite verification within 90 calendar days per 5.11.3 and one based on the date of the corrective action plan per 5.11.2 c.

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IATF FAQ 6.23.2014

# 25 Certification decision Q: 5.12 Is it possible to make a certification decision on day 61 for an audit with a major nonconformity if the onsite special audit was not conducted until day 89, per 5.11.3?

A: If the effective implementation of corrective action for a major nonconformity is accepted at day 61, the CB cannot conduct the certification decision until the onsite verification has been conducted. If a major nonconformity is accepted as 100% resolved at day 61 and based on the client's action plan the onsite special audit cannot be done before the maximum of 120 days (or before cert expires), than per Rules 5.12 d) a certification decision can be made at day 61, as long as, Rules 5.11.2 were met.

NOTE: Please do not get anywhere near the 60 or 90 day deadline as required by the Rules. The nonconformance has to be accepted by the Lead Auditor ( the evidence provided sufficient to meet the intent of the 100% resolved ) and go through the Review Process. If not – minors get escalated to Majors and Majors lead to Certificate Withdrawal.

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IATF FAQ 6.23.2014

# 29 5.2 b) Third shift workQ: If a client has two shifts (7:00am – 19:00pm and 19:00pm – 7:00am), can the audit team work more than 8 hours to audit the 2nd shift since it operates outside of normal working hours of the site?

A: The answer is no. If the client only has two manufacturing shifts, than the CB cannot work longer than 8 hours to cover the 2nd shift which may operate outside of the normal working hours (i.e. 19:00pm - 7:00am). The audit plan start or end times will need to be adjusted to ensure the 2nd shift is covered in an 8 hour audit day

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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.

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Current List of Support Functions from IATF DB

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Selection on the CF160 Audit Planning Information Form

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General Comments

Changes that require notification New executive Management, contacts, Senior positions of responsibility New Location, additional building, warehouse location, etc. Change in responsibilities – Corporate remote Location is now

responsible for all Purchasing Decisions. Remote Location has new responsibilities Any merger, acquisition, change in ownership.

Contact your Customer Service Professional when the changes occur. If you do not know who your Customer service professional is, contact:

Michael.Spurlock@us.dqs-ul.com

If you add a location and don’t know who your Sales representative may be, contact:

Steve.Pinter@us.dqs-ul.com

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General Comments

June 2013: CD

(Committee Draft)

May 2014: DIS

(Draft International Standard)

July 2015: FDIS

(Final Draft International Standard)

September 2015: IS

International Standard

201520142013

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Questions ?