sqa implementation customer trainingsmithersregistrar.com.cn/smitherssqa/media/smith... · – sqa...

Michael Fournier

07/10/14

SQA

TS4 Rules Revisions

Implementation –

Customer Training

www.smithersregistrar.com CONFIDENTIAL 2

Agenda – Why Rules 4?

– Changes (and clarifications!)

– SIs and FAQs

– Questions

Overview


TS 4 Rules • Issued 10/01/13

• Effective by 04/01/14

• Changes affect – Clients

– Office staff

– Auditors

Why Rules 4?


• Strengthen the Value & Credibility of ISO/TS16949 • IATF & CB’s “Raising the Bar” • TS Certification = “Good or Improving Performance”

for certified automotive suppliers & CBs • Poor performing suppliers should NOT be

certified • Enhanced focus on

– CB

– Client

– Customer performance • Reduced variation between

– CB’s

– Oversight offices • Communication & execution is imperative.

Why Rules 4?


• Customer Project: – SQA ongoing project to contact all certified TS

customers to validate

• Current conditions

• Manufacturing site extensions

• Support sites

– Approach - Chronological order with prioritization on known “manufacturing site extensions.”

– 3 months ahead of the schedule. • Process Updates

– Revised procedures & forms (i.e. CRW, Audit Plan & Report, CAR, etc.)

– Ongoing based on auditor feedback

SQA Actions


Manufacturing Site Extensions

Existing site extensions will need to transition

into single certified sites between April 1, 2014

and April 1, 2015

Transition audit site extension

Stage 2

At recertification days.

Any support activities that occur at this site will

also be audited at that time

Corporate scheme can apply if conditions met

New certificate will be issued for the site

Changes/Clarifications


Eligibility for TS Certification (Section 1.0) Manufacturing sites defined as sites where

production and/or service parts are manufactured

and supplied to automotive customers

Term “subscribing customer” has been removed

The quality management systems must support all

automotive customers (requiring TS or not).

• Review your current customers to identify any supplier quality

manuals for applicability

• CSR often buried in PO/contractual documents.

• Need to ensure control plans, FMEA’s , MSA, and other core

tools that may have not been required previously



Eligibility for TS Certification (Section 1.0) Sanctioned Interpretations (SIs) – April 2014

• SI 02 – Exclusion of site that could be registered if

customer does not require TS registration

Frequently Asked Questions (FAQs) – May 2014

• FAQ 01 – If IATF OEM act as “up-fitters” then suppliers of

parts eligible.

• FAQ 02 – Value added activities on a customer site – not

eligible for certification but may be a “supporting activity”

under “Service” for IATF DB entry

• FAQ 03 – "client” with multiple “sites" of which only some

are having “automotive production – only sites with

automotive are eligible for certification

• FAQ 04 – Production material at a certified site to be

excluded – No, if used for automotive production



Certification agreement (3.1)

Must be legally enforceable

States some of the following

Cannot refuse the presence of an IATF Witness Audit

of SQA

Cannot refuse the presence of an IATF representative

or delegate

Cannot refuse the presence of an SQA Internal

Witness Auditor

Consultants cannot be physically present during the

audit or participate in audits in any way



Notification of Changes (3.2)

Identifies what material changes require

notification

Include some of the following

Legal & commercial status

Changes in organizational personnel in key roles

IATF OEM special status conditions

Major changes in processes/management system

Failure to inform SQA could result in certificate withdrawal




FAQs

FAQ 05 – Should the CB issue a MAJOR

nonconformity (CAR) if changes not communicated? –

Yes – considered a breach of the legally enforceable

agreement.

FAQ 06 – Site moves to new address - considered a

“full site move” if all the below met

> 80% of employees relocate

Same equipment and processes (no changes or

additions)

Same products (no changes or new products)

SQA notified prior to move

If above met – Stage 2 (initial) at recert days; if not full

Stage 1 & 2 audit




FAQs

FAQ 07 – Site moves to new address - considered a

“partial site move” if any one of below met

< 80% of employees relocate

Equipment and processes (changes or additions)

Same products (changes or new products)

SQA not notified prior to move

If above met – full Stage 1 & 2 audit



Audit Day Determination (5.2)

Changes in on-site time

1.0 hour added on to the audit on day 1 to review

current score card/performance data

1/3 the on site time to be auditing production processes

Verification of effectiveness for previously identified

corrective actions must be separate and adds time to

the audit.

FAQ 09 – If MINOR CAR effectiveness verification occurs

during a special audit then additional time is not required

to be added at the next audit activity..

SQA will continue to verify the continued effectiveness

of Corrective Action at the next audit



Audit Day Determination (5.2)

Changes in on-site time

If the number of employees changes during the audit

then the audit time changes for that audit

Audit day

• 8.0 hours for a full day

• 4.0 hours for a half day

• Exception is auditing off (3rd) shift activities

o Can apply up to 4 hours on one of the days for the audit.



Audit Planning (5.7) Pre-audit planning information

Submittal per SQA’s Pre-audit planning letter sent out

approximately 60 days prior to the audit

Auditors use this information to create a performance

based audit plan

Failure to submit • Add time to audit to review before opening meeting (up to

4 hours, depending on the extent of information)

• Separate from the 1.0 hour required review

• Could lead to suspension per 8.1.g

See also FAQ 31 at the end of presentation

Audit plans more detailed List all manufacturing processes to be audited by shift

Interactions with any remote supporting function`

Which customer specifics are to be audited.



On-site Audit Activities (5.8)

New customers since last audit

Implementation of requirements

Manufacturing processes

Stage 2 and Recert – all manufacturing processes

Surveillance – all manufacturing processes during the

surveillance cycle

Auditor must use the Process Flow Diagram, FMEA,

the Control Plan during the audit of the shop floor.

Shifts

All shifts

All audits



On-site Audit Activities (5.8)

FAQ 21 – Auditing customer performance &

requirements

Every audit - Verify IATF OEM performance reports (i.e.

scorecards) on line at each audit (if OEM IATF

publishes on-line)

Every audit - Auditor review customer satisfaction for all

automotive customers & and investigate any

complaints, including the client’s responses , with

priority given to applicable IATF OEM's regardless of

how large or small of a customer they are to the client.

IATF OEM CSR effective implementation sampled over

the three (3) year audit cycle.



Audit Findings (Section 5.9) Audit Termination

As agreed between client, Team Leader and SQA

MAJOR CARs can be the basis for this termination

Consequences o Surveillance

• Suspension

• Complete a full repeat surveillance audit within 90 days of

closing meeting date

o Recertification • Suspension

• Complete a full repeat recertification audit within 90 days

of closing meeting date but

• audit must meet the timing of 5.1.1

• If timing exceeded – Stage 1 & Stage 2 audit

o Transfer • Stage 1 & Stage 2 audit



Audit Report (5.10)

More content then before

Audit process summary

Includes performance (objectives/targets and

performance thereto)

Support site processes and interactions clearly

described

Copy of the final audit plan maintained as a record

Shall be acknowledged by the client

Use of SQA Opening/Closing Sheet acknowledgement

of report received

If final report provided after audit departure

• Acknowledgement email

• Within 15 days



Non-conformity Management (5.9,5.11, & 8.0)

Major CARs

Surveillance

• Auditor required to justify CAR classification as “Major”

• Within <15 calendar days (6.7)

o Implement correction

o Identify root cause

o Submit to SQA Auditor

• Suspension is mandatory (8.3)

• On-site verification is required (special audit)

Recertification

• Same above

• Timing (i.e. when the current certificate expires) may

shorten time for response



Non-conformity Management (5.0, 6.0 & 8.0)

Minor CARs

Surveillance

• Auditor required to justify CAR classification as “Minor”

• Within 60 calendar days

o Implemented correction

o Identified root cause

o Corrective action taken and implemented

o Submit to SQA Auditor

Recertification

• Same as surveillance

• Timing (i.e. when the current certificate expires) may

shorten time for response



Non-conformity Management (5.0, 6.0 & 8.0) All CARs

Root Cause Analyses • Shall utilize a documented problem solving method

• Includes 5-Why, 8D, Fishbone, etc.

Corrective Action • Shall be implemented.

• Related to the identified root cause.

Closure within 90 days by SQA • Allows for some time between submittal of corrective

action evidence submission by 60 days and closure per

rules at 90 days

• 100% Resolved

o Only under special circumstances

o Requires on-site verification prior to the next

scheduled audit



Non-conformity Management (5.0, 6.0 & 8.0) On-site Verification (5.11.3)

Major • Within 90 calendar days

• If CA is ineffective the certificate will be withdrawn

Minor • At the discretion of SQA

• Within 90 calendar days

• If CA is ineffective

o Major CAR issued against 8.5.2

o Previous Minor is raised to a Major

Verification of CAR Effectiveness next audit (5.11.2) Required for all CARs issued at the previous audit if not

verified effective during a special audit. If CA is ineffective

• Major CAR issued against 8.5.2

• Previous Minor is raised to a Major



Other Noteworthy FAQs

FAQ 29 – Auditing Shifts

Question: Two shifts (7A – 7P & 7P – 7A) - Can the audit

team work > 8 hours to audit the 2nd shift as it operates

outside of normal working hours of the site

IAOB – No - Audit start or end times will need to be adjusted

to ensure the 2nd shift is covered in an 8 hour audit day.



Other Noteworthy FAQs

FAQ 31 – Pre-Audit Information Submission

Question - What level of detail shall the client provide as an

input for developing an audit plan?

IAOB Response

• Documented statements of a quality policy and objectives

• Quality manual & documented processes

• Process map showing linkages & interactions

• Documented linkages between processes & ISO/TS

• Internal Audits - Summary of system, process & product audits

since last certification body audit, including a summary of the

total no. of nonconformities by audit type, classification of each

nonconformity & relevant requirement (audit criteria)

• Management Review output/action items



Summary

– These are the highlights!!!!!!!!!!!!

– Client is responsible for knowing the rules

– We highly recommend you purchase a copy

– Buy at AIAG

» https://www.aiag.org/source/orders/prodDetail.

cfm?productDetail=TSRULES-4

– Rules 4th Edition SIs & FAQs

» Available at http://www.iatfglobaloversight.org

– Customer Specific Requirements

» IATF OEMs - http://www.iatfglobaloversight.org

» Others - http://www.customerspecifics.com


https://www.aiag.org/source/orders/prodDetail.cfm?productDetail=TSRULES-4




http://www.iatfglobaloversight.org/

http://www.iatfglobaloversight.org/

http://www.customerspecifics.com/

http://www.customerspecifics.com/


Q&A

Smithers Quality Assessments

425 West Market Street

Akron, OH 44303

www.smithersregistrar.com

(330) 762-4231 ext. 1440

[email protected]

mailto:[email protected]

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