Featured Speakers: Charles Blair, Automotive Program Manager at UL DQS Inc.
The new TS 16949 Rules went into effect on April 1st, 2014. Since then, UL Charles BlairDQS Inc. has received a lot of questions regarding the changes.
Join Charles Blair, Automotive Program Manager at UL DQS Inc., as he addresses the following:implementation concerns, impact of major NC, FAQ update, remote locaitons and organizational process maps.
2. DQS–ULGroup
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 from
IATF OEM
Customer
IATF Oversight Office.
Special Status (as examples):
GM: CS2, NBH
FORD: Q1 Revocation
CHRYSLER: Needs Improvement
VW: C
DAIMLER: Q-Help, NBH
FIAT: CLS2, NBH
Failure to provide Planning information.
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5.11 – NC managementReasonforthechange:
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.
Summaryofthechanges
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
No. 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:
25. DQS–ULGroup
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
# 8
Onsite verification of corrective actions
5.2 d)
5.11.2
5.11.3
Q: 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 work
Q: 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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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
39. DQS–ULGroup
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