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Supplier Quality Improvement Manual
Technical Supplier Manual
Revision 10
Effective date : 20 May 2011
Approved by
Technical SectionTokai Eastern Rubber (Thailand), Ltd.
Issued by Checked by
Supplier Quality Improvement Manual
ContentsItem Page
1. Quality assurance ideality 1
2. Purpose 1
3. Scope 1
4. Requests for supplier
4.1 Initial Control Organization 2
4.2 Approval Initial Part of Supplier 3
4.2.1 Production Preparation Schedule 4
4.2.2 SPTT Audit 4
4.2.3 Inspection Standard 5
4.2.4 SBSC 7
4.3 Initial Delivery Control 8
4.4 PPAP Activity 8
4.4.1 Reason to submit PPAP 8
4.4.2 PPAP Retention / Submission Requirement for Supplier 9
4.4.3 TER PPAP Status 23
4.4.4 Record Retention 23
4.5 Process Change Requirement 24
4.5.1 Reason to information of process change 24
Submission requirement for supplier
4.5.2 Delivery requirement after PCN approved 25
4.5.3 Change Control Flow 26
4.5.4 Record Retention 27
4.6 Guideline for Environmental Hazardous Substance Management 27
4.7 Control of initial nonconforming products(NC) 32
5. Attachment List 33
Technical Supplier Manual Change Notification
Technical Supplier Manual
Supplier Quality Improvement Manual
1. Quality assurance ideality
1.1 Supplier shall produce parts that meet to TER satisfaction as purchasing agreement.
TER would approve parts that shall be controlled quality continuously.
1.2 Supplier shall improve production process to achieve condition and requirement and
prepare quality assurance of part have not problem after delivery Especially for problems in TER
shall be corrected and prevented immediately.
1.3 TER shall audit QA system of supplier including monitoring and advising in order to
assure quality of supplier efficiently and continuously.
1.4 To conduct coordination between TER and supplier.
1.5 Supplier shall apply ISO9000 or ISO/TS16949 to implement in Quality Assurance
system.
1.6 Initial part of supplier shall approved by TER before start Mass production.
2. Purpose
This guide to Technical Supplier Manual is defined a standard of quality assurance for new or
changed product as supplied to "Tokai Eastern Rubber (Thailand),Ltd."
3. Scope
This manual applies to the quality assuarance activities of suppliers for new or change, which
related to TER in assembly product. If it difficult to carry out them please contact to Technical section,
QA&Technical department of TER
Page 1 of 34 Technical Supplier Manual
10
Supplier Quality Improvement Manual
4. Requests for supplier
4.1 Initial Control Organization
Establish and maintain the quality assurance system. The supplier shall assign a person
who responsible in quality and delivery for initial part. This assignment has aimed to ensure an establishment
of a consistent quality assurance and delivery system to cover all processes of each supplied product
for TER and response in our satisfaction of requirements. Supplier shall submit to Technical section within
7 days after received New Part Notice from Technical / TER.
** If Contact person change. Please Review /Revise this organization and submit to Technical
section within 7 days.
Page 2 of 34 Technical Supplier Manual
Factory ManagerName : Mr.N. YoshidaE-mail : n.yoshida@ter.co.th
Tel : (038) 893-557-61 ext.162Mobile Phone : 081-9496355
< Manager > < Staff >Project Leader (Department): Project Leader (Department):Name : Name :Position : Position :E-mail : E-mail :Tel : Tel :Mobile Phone : Mobile Phone :
Core Team # 1 (Department): Core Team # 1 (Department):Name : Name :Position : Position :E-mail : E-mail :Tel : Tel :Mobile Phone : Mobile Phone :
Core Team # 2 (Department): Core Team # 2 (Department):Name : Name :Position : Position :E-mail : E-mail :Tel : Tel :Mobile Phone : Mobile Phone :
Core Team # 3 (Department): Core Team # 3 (Department):Name : Name :Position : Position :E-mail : E-mail :Tel : Tel :Mobile Phone : Mobile Phone :
Core Team # 4 (Department): Core Team # 4 (Department):Name : Name :Position : Position :E-mail : E-mail :Tel : Tel :Mobile Phone : Mobile Phone :
Core Team # 5 (Department): Core Team # 5 (Department):Name : Name :Position : Position :E-mail : E-mail :Tel : Tel :Mobile Phone : Mobile Phone :
Core Team # 4 (Department): Core Team # 4 (Department):Name : Name :Position : Position :E-mail : E-mail :Tel : Tel :Mobile Phone : Mobile Phone :
Rev.01
(038) 893-557-61 ext.125 (038) 893-557-61 ext.125081-865-2072 081-330-4431
PC Asst.Mgr. Supv.w.prapan@ter.co.th k.narest@ter.co.th
Production Engineer Production EngineerMr.W.Prapan Mr.K.Narest
Production Control Production ControlMr.W.Prapan Mr.P.Sakdinan
081-865-2072 081-7825986(038) 893-557-61 ext.125 (038) 893-557-61 ext.189
w.prapan@ter.co.th p.sakdinan@ter.co.th
PC Asst.Mgr. Supv.
081-629-4615
Production Mgr.
TER Engineering Div.
Mr.W.CherdpanMkt.Mgr.
w.cherdpan@ter.co.th
02-685-3557-60 ext.110
Engineering Div.Mr.T.Makino
Production Div. Production Div.
Engineering Div.
Marketing Div. Marketing Div.
Quality Div. Quality Div.
02-685-3557-60 ext.112
(038) 893-557-61 ext.116
084-084-6660
Production EngineerProduction Engineer
081-663-6295
Mr.C.AtthayaProduction Supv.
c.atthaya@ter.co.th
(038) 893-557-61 ext.175081-723-2936
Mr.K.Projob
prajob@ter.co.th
081-663-6295
Mr.M.YoothasisthProduction Engineer Supv.
m.yoothasisth@ter.co.th
(038) 893-557-61 ext.175081-750-7738
Mr.K.ProjobProduction Mgr.prajob@ter.co.th
(038) 893-557-61 ext.175
(038) 893-557-61 ext.175
089-939-5191
Mr.S.EkkaratQA Supv.
s.ekkarat@ter.co.th
(038) 893-557-61 ext.117081-377-8504
Ms.S.SaranyaQA & Technical Dept.Mgr.
s.saranya@ter.co.th
t.suppachai@ter.co.th
t.makino@ter.co.th
(038) 893-557-61 ext.210081-664-9426 085-436-4241
t.chawalit@ter.co.th
(038) 893-557-61 ext.112
Mr.T.SuppachaiMkt.Staff
Core team4
QA & Technical GM
Marketing Div. Quality Div. Production Div.
Mr.T.ChawalitTechnical Dept.Supv.
PE Div. PC Div. WH Div.Core team6
Project Organization Chart
Core team1
Project Leader
Core team2 Core team3
Project Name
RT-50Supplier Name
Core team5
10
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Supplier Quality Improvement Manual
4.2.1 Production Preparation Schedule(PPS)
Supplier issue PPS which contains New Part Notice, TER master plan
(TD0, TM0, TM1, MP), SPTT stage and detail of part preparation. After received plan Supplier shall issue
Supplier plan submit to TER within 2 week and update supplier plan in PPS submit to Technical every
month. Technical will check progressive of part from PPS.
Supplier shall issue supplier's PPS to Technical / TER after received New Part Notice by
7 working days. Supplier shall update progressive of PPS by 25th of wery month
4.2.2 SPTT Audit
Technical set SPTT activity for
1. 100% Quality meet to TER requirement
2. 100% On time delivery in each stage
3. Close communication between TER and Supplier
SPTT activity has 3 steps and criteria as list below.
Page 4 of 34 Technical Supplier Manual
Supplier : XXXXXXXXXXXXXXXX 3Part No. : XXXXXXXXXXXXXXXX 2 Approved Approved Checked Checked Approved Checked IssuedPart Name: XXXXXXXXXXXXXXXX 1Mfg.No.: XXXXXXXXXXXXXXXX PLAN 0 dd/mm/yy xxxx
ACTUAL Rev. Date PIC President Manager Advisor Engineer President Manager Engineer
7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1
Raw Material& CKD XXXComponent Local parts XXX
Process planning XXXXXXXXXxProd. Of Tooling/Equipment XXXXXXXXXxProd. Of Checking Fixture XXXXXXXXXxTry-out XXXXXXXXXxTurning & Modilication XXXXXXXXXxTooling & Equipment Transfer XXXXXXXXXxProd. Of Tooling/Equipment XXXXXXXXXxProd. Of Checking Fixlure XXXXXXXXXxInstallation XXXXXXXXXxTry-out XXXXXXXXXxTuning & Modification XXXXXXXXXxLow Volume Production Trial (LVPT) XXXXXXXXXxHigh Volume Production Trial (HVPT) XXXXXXXXXxStart of Vulume Production XXXXXXXXXxDimension & Appearance XXXXXXXXXxMaterial Evaluation XXXXXXXXXxPerformance Evaluation(Sample part) XXXXXXXXXxPerformance Evaluation XXXXXXXXXx(Re-comfirmation of Local Prod. Part) XXXXXXXXXxInspection Standard XXXXXXXXXxQC Process Chart XXXXXXXXXxProcess Standard (WI,QCS,etc.) XXXXXXXXXxPPAP Submit (SPSW Submit) XXXXXXXXXxEducation & Training XXXXXXXXXx
sign sign sign
20112010
Supplier Plan
TER Plan
CUSTOMER Plan
Tokai Eastern Rubber(Thailand),Ltd.
History Recordnew issue sign sign sign sign
THAI
Quality Document
Evalution
Production Preparation Schedule
Master Schedule
Proc
ess P
repa
ratio
n
ResponsibilityActivities
JAPAN
Supplier:________________
S-Lot ET PT1 PT2 SOP
TM1TM0TD0 MP
TM1TM0TD0 MP1stSPTT 3rdSPTT2ndSPTT
10
Supplier Quality Improvement Manual
SPTT
1st Audit
2nd Audit
3rd Audit
Supplier shall control part follow Approval Initial Part of Supplier schedule.
4.2.3 Supplier shall issue Inspection standard and record which identify all measuring items
and specification for supplier product testing and submit to TER after received drawing within 2 weeks
Supplier shall maintain inspection item which TER approved. (TER form)
Page 5 of 34 Technical Supplier Manual
Stage Part Quality Quantity ReferenceActivity
SPTT audit check sheet
(Trial Dimension) (CKD or Local) -Co-check dimension of part
TD0 Part Off Tool n=3 pcs/shots -Check tooling status
Can rework
TM0 Part Off Tool Refer to Pilot PO
TM1 Part Off Tool Refer to PO -Check production process
-Confirm capacity PPAP Approved
MP Part Off Tool Refer to PO -Confirm production process
Can not rework -Confirm part before shipping
SPTT audit check sheet
(Trial mold at THA) Off Process -Check capacity
(Trial mold at JP) Off Process
Can not rework -Supplier PPAP Approve
SPTT audit check sheet
(Mass Production) Off Process
Doc. No. TES-IY- DCR No. Rev. 0
(DATE)
MFG. NO PART NO PART NAME
MODEL ROUTE MATERIAL RANK
INSPECTION INSPECTION SAMPLING INSPECTIONCRITERION INSTRUMENT PLAN METHOD
①
②
③
④
⑤ ※
⑥ ※
⑦
⑧
⑨
⑩ ※
⑪
⑫
⑬
⑭
DIMENSION
DIAMETER CALIPER
15.5 (MIN) CALIPER
RADIUS B
CALIPER
A TSB1001G-11.9 EVIDENCE
B 14 -0.25
B
CUSTOMER QA DEPT
Dimen-sion
THREAD ACCURACY
LENGTH
B
B
THREAD GAUGEM10 X 1.25
OUTER DIAMETER
LENGTH B
B
DIMENSION B
DIAMETER B
B
DIMENSION
xxxxxx
ITEM
TSB1001G-11.9
NO INSPECTION ITEM RANK
xxxxxx
INSPECTION STANDARD
xxxxxxxxxxxxx
26 0 HEIGHT GAUGE / CMM
CALIPER / CMM9.5 ( MAX )
PAGE OF
( 1 / 2 )
HEIGHT GAUGE / CMM
SAFETY PART
xxxxxxxx
FINISHEDUNFINISHEDMETAL
20-May-10
40 + 0.5
n = 5, c = 0 / METAL LOT
※ n = 5, c = 0 / LOTSUPPLIER DATA
CHECK ONLY
1.35 ( MIN ) HEIGHT GAUGE / CMM
PROFILE
∅ 21.5 ( MAX )
R0.5 ( MIN )
CHECK
ALL METAL LOT MATERIAL CERTIFICATE
ISSUE
MATERIAL CERTIFICATE
CALIPER
SUPPLIER QA DEPT (TER)
APPROVE CHECK CHECK CUSTOMER TOKAI EASTERN RUBBER (THAILAND),LTD. APPROVE CHECK
SUPPLIER XXXXXXXXXXXXXXXXXX
ISSUE DATE REVISION RECORD
∅ 9.5 -0.15
n = 1, c = 0 / INITIAL OR PROCESS CHANGE
/ IF NECESSARY
BALANCER n = 5, c = 0 / METAL LOT
EVIDENCE
33 g
MATERIAL OF PART
NO USE OF 4ENVIRONMENTAL SOCs A CONFORM TO
TSZ0001G
VISUAL n=10%,c=0 / METAL LOTALL(SUPPLIER)
TSH7903GTSH6524G-B
Appea-rance
SURFACE TREATMENT B ZINC COATING
Charac-teristic
WEIGHT Ref
+2.5
0
0
10
10
Supplier Quality Improvement Manual
Inspection Rank List Control
For (Safety) (Regulation) (Emission)
Page 6 of 34 Technical Supplier Manual
S S - Test before shipping part to
TER evey lot- Use SPC control
RankControl Method
Dimension Appearance Characteristic Remark
-Visual 100% Inspection - Test before start production evey lot - Use SPC control
-Sampling check
Control methodand frequencyrefer to TER'srequirement
whichagree together
-Visual 100% Inspection
-Test before shipping part to TER
- Test before start production evey lot - Use SPC control
-Test before shipping part to TER
A
B
C
S R ES
R
E
S S
NO. 1 2 3 4 5 X JUDGE TESTEQUIPMENT NO. 1 2 3 4 5 X JUDGE
THREAD ACCURACYM10 X 1.25
Due
LENGTH40 ± 0.5
( 39.50 ~ 40.50 ) Due
LENGTH + 2.526 - 0
( 26.0 ~ 28.5 ) Due
DIMENSION
Due
RADIUS
Due
DIMETER
Due
OUTER DIMETER
Due
DIMENSION 014 - 0.25
( 13.8 ~ 14.0 ) Due
DIMENSION
Due
DIMETER 0∅ 9.50 - 0.15
( 9.35 ~ 9.50 ) Due
⑫
⑭
Keep period : EFFECTIVE DATE :
DIM
ENSI
ON
APPE
ARAN
CE
CALIPER
⑨ CALIPER 15.5 ( MIN )
⑤ R 0.5 ( MIN )
⑥
③
PCS
④ 9.5 ( MAX )
1.35 ( MIN )
∅ 21.5 ( MAX )
⑩
⑧
CALIPER
PCS
PROFILE
HEIGHT GAUGE / CMM
GOODGOOD
CALIPER/CMM
HEIGHT GAUGE / CMM
CALIPER
PCS NG PCS
CHECKED BY
INSPECTED BY
NG
n=1 , c =0 / INITIAL OR PROCESS CHANGE &
IF NECESSARY
ALL SUPPLIERn=10%,c=0/LOT
TER⑪
SURFACE TREATMENT
VISUAL
n=5,c=0/METAL LOT
MATERIAL OF PART (TSB1001G-11.9)
SPEC. INSTRUMENT SAMPLING PLAN
②HEIGHT
GAUGE / CMM
①THREAD GAUGE
n=5,c=0/METAL LOT
CUSTOMER NAME
PART NAME
SHIPPING QT'Y
SKETCH
NO USE OF 4 ENVIRONMENTAL SOCs (CONFORM TO TSZ0001G) EVIDENCE
⑦
PART NO.
MFG NO.
MODEL
TER 's DATA
INSPECTION DATE
INSPECTION QTY
SUPPLIER 's DATA
SHIPPING DATE
QAINSPECTION RECORD ( METAL PART )
NG QTY
RECEIVING LOT
SUPPLIER NAME
SHIPPING LOT
EVIDENCE ※ SUPPLIER DATA CHECK ONLY
CHAR
ACTE
RIST
IC
⑬ WEIGHT: 33 g. (REF.)*VICKER
HARDNESSTESTER
ZINC COATING
(TSH7903G, TSH6524G-B)
Keep period :
(GM)
APPROVE
RECEIVING LOT
INSPECTION QTY
QASKETCH
MFG NO. SUPPLIER 's DATA TER 's DATA
PART NO. INSPECTION DATESUPPLIER NAME
INSPECTION RECORD ( METAL PART )
SHIPPING DATE
SHIPPING LOTPART NAME
MODEL
CUSTOMER NAME
SHIPPING QT'Y NG QTY
History Record
Rev. Date Revisior Record PIC
TER
CHECKED
(SUPV.)
SUPPLIER
ISSUED CHECKED
APPROVE
(MGR.)
APPROVE APPROVE
(ENGINEER) (SUPV.) (MGR.) (MGR.)
xx-xxxxxx-xxxxxxxxxxxxxxxTERxxxxx
xxxxx
xx-xxxxxx-xxxxxxxxxxxxxxxTERxxxxx
xxxxx
Supplier Quality Improvement Manual
4.2.4 SBSC
SBSC is Supplier Banned Substance Check Sheet
Suppliers shall
check your material and reply to Technical by attach with TM0 Data. Concentration of banned substances
calculate from MSDS or Chemical ingredient. (Attach sheet No. 18)
SBSC
Page 7 of 34 Technical Supplier Manual
Tech Tech Mgr. Tech Supplier
Supplier Name :
Address :
Responsible person :
Reason for submission
New model New Materials / Chemical Change ECN no. … … … Current material Correction for previous discrepancy with Mfg.No. ……...………….Change Process ……………..to……………….
Please fill form of your material or chemical name and concentation if it don't have these chemical Substanced, Pleases fill in that column.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
1
2
3
4
5
6
7
8
1 Cadmium and cadmium compounds 11 Polybrominated diphenylethers (PBDE) 21 Trinuvin 3202 Lead and lead compounds 12 Other brominated organic compounds 22 Dimethylfumarate ( DMF )3 Mercury and mercury compounds 13 Organic tin compounds 23 REACH (SVHC)4 Hexavalent chromium compounds 14 Asbestos 24 Other5 Polychlorinated biphenyls (PCB) 15 Azo compounds6 Polychlorinated naphthalenes (PCN) 16 Formaldehyde7 Polychlorinated terphenyl (PCT) 17 Polyvinyl chloride (PVC) and PVC blends8 Chlorinated paraffins (CP) 18 Perfluorooctane sulfonate anion (PFOS)9 Other chlorinated organic compounds 19 Recycled Meterial
10 Polybrominated bihenyls (PBB) 20 Polycyclic Aromatic Hydrocarbon(PAHs)
* For specification refer to Sony Technical Standards SS-00259, Yano standards and Green Procurement Standard of Matsushita group and GGP-001 of Pioneer Group *For REACH refer to the European Chemical Agency has announced the latest SVHC Candidate List - please see information from UK. The summary of the obligations is available on ECHA's website.
For Supplier
Approved by: ………………………… Checked by …………………………Checked by …………………… Approved by ………………………(Mgr) (Technical Engineer) (Technical SoC) (Tech Mgr.)
Date : ……../……../……… Date : ……../……../……… Date : ……../……../……… Date : ……../……../………
Page 1 of 1
For TER
Supplier
Supplier Banned Substance Check Sheet (SBSC)
No.Material Concentration of Banned Substances (ppm)
Chemical Name
Remark
7
77
7
7
Supplier Quality Improvement Manual
4.3 Initial Delivery Control
Part delivery in each stage shall attached Shipping Tag follow this manual.
4.3.1 TD0 Stage (White color tag) 4.3.6 Last Lot (PCR Old Part)
4.3.2 TM0 Stage (Orange color tag) 4.3.7 First Lot (PCR New Part)
4.3.3 TM1 Stage (Sky blue color tag)
4.3.4 MP Stage (Green color tag)
4.3.5 Special Stage (Pink color tag)
Supplier shall attach delivery tag to every box and invoice.
4.4 PPAP activity
PPAP: Production Part Approval Process is a activity for preparation of part and document to
control process and inspection to reach TER requirement before part approval process in TER. Refer to
Production Part Approval Process : PPAP 4th edition
4.4.1 Reason to submit PPAP
4.4.1.1 New part or product (e.g., a specific part, material, or color not previously
supplied to TER).
4.4.1.2 Correction of a discrepancy on a previously submitted part.
4.4.1.3 Product modified by an engineering change to design records, specifications,
or materials.
4.4.1.4 Any situation required by TER example 4M Change (Man, Machine, Method and
Material)
Page 8 of 34 Technical Supplier Manual
TO: ARRIVAL DATE : dd/mm/yySUPPLIER : XXX MODEL: XXX
PART NO. : XX-XXXXX MFG. NO. : XX-XXXPART NAME.: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Q'TY (Pcs.) XXX P/O NO. XXX
PART FOR TD0 TM0 TM1 MP Other
Change PCN No.
DELIVERY BY MR.XXXXXXXX PHONE XXX-XXXXXX
Technical Contact Person IPP Name ESIE MR.XXXXXXXXXX
TOKAI EASTERN RUBBER (THAILAND), LTD.Technical
10
Supplier Quality Improvement Manual
4.4.2 PPAP Retention/Submission Requirement for Supplier
Supplier shall submit document follow this requirement separate to supplier group or any required
by TER (supplier shall to use TER format some requirement at symbol is )
S = Supplier shall submit to TER and retain a copy of records or documentation items at appropriate locations.
R = Supplier shall retain at appropriate location and make available to TER upon request.
Page 9 of 34 Technical Supplier Manual
Metal part, Plastic part, Rubber part
Rubber CompoundPlastic Material
ChemicalOther
1 Design Record S - S
-For proprietary components/ details R - R
-For all other components/ details S - R
2 Engineering Change Documents S - S
(List of engineering standard and drawing) -
3 Customer Engineering Approval S - S
4 Process Flow Diagrams S S S -
5 Process FMEA S - R -
6 Control Plan S S S -
7 Measurement System Analysis Studies S - - -
8 Dimensional Results S - S
9 Material, Performance Test Results, Supply Chain S S S
10 Initial Process Studies S - - -
11 Qualified Laboratory Documentation S - S -
12 Master Sample S - S -
13 Checking Aids R - - -
14 Records of Compliance with Customer-Specific Requirements S - S -
15 Part Submission Warrant (PSW) S S S
16 SBSC, Certification of Non-Use of the Controlled Substances S S S
17 Cover sheet and Test report S S S
18 Material Data Sheet S S S
19 Declaration of no use of PFOS S S S
20 SVHC survey S S S
Requirement Fix TER format
Production Matetial
10
Supplier Quality Improvement Manual
4.4.2.1 PPAP Retention/Submission Requirement for Supplier
TER issue "Supplier PPAP Request Sheet" to supplier after TM1 stage. Supplier shall
submit document/PPAP folow the request sheet
Remark : TER will control Supplier PPAP by Supplier PPAP Request Sheet
4.4.2.2 Design Record (List of Engineering Record)
Supplier shall have the design record for the saleable product/part, including design
records for components or details of the saleable product/parts which approved and distributed by TER.
Where the design record is in electronic format, e.g., CAD/CAM math data, the supplier shall produce
a hard copy (e.g.pictorial, geometric dimensioning & tolerancing[GD&T] sheets, drawing) to identify
measurements taken.
Page 10 of 34 Technical Supplier Manual
Supplier PPAP Request Sheet Model : _______________
Supplier Name : Submit Criteria: Production Matetial
Part No. : ❒ Metal part, Plastic part, Rubber part
Part Name : ❒ Rubber Compound, Plastic Material, Chemical
Revision : E.C.I. No. : ❒ Other
Due Date of Submission : _______________________ Received Date from Supplier : _____________________
1
2
3
4
5
6 ❒
❒
❒❒❒ ❒ Accept ❒ Not Accept
❒ Accept ❒ Not Accept
❒ Accept ❒ Not Accept
❒ Accept ❒ Not Accept
❒ Accept ❒ Not Accept
TER's Request
❒ Accept ❒ Not Accept
❒ Accept ❒ Not Accept
❒❒❒
TER Judge
❒ Not Accept❒ Accept
RemarkRequirement
Control Plan
Customer Engineering Approval
Process Flow Diagrams
Process FMEA
Design Record
-For proprietary components/ details
-For all other components/ details
Engineering Change Documents(List of engineering standard and drawing)
19
20
Supplier PPAP Result
❒ Approved ❒ Interim ❒ RejectedResubmit within ________________ Resubmit within ________________
Detail of document (Not Accept item)
Distribution Flow : TER(Technical) Supplier TER(Technical)
Request Submit Approve
Declaration of no use of PFOS
SVHC survey
SupplierTechnical
❒ Accept ❒ Not Accept
❒ Accept ❒ Not Accept
❒❒
SupplierApprove Check Incharge Approve Check
TER
10
10
Supplier Quality Improvement Manual
4.4.2.2(a) When supplier received "List of Engineering Drawing to Supplier" shall reply to
TER within 3 days for convenient date to receive new engineering drawing by supplier must to receive
drawing within 7 days
4.4.2.2(b) In receive date supplier must return "Old Engineer Drawing" to TER
4.4.2.2(c) Supplier must review new engineering drawing by record date of "First Lot,
Last Lot" in List of Engineering Drawing to Supplier document and reply to TER within 7 days after supplier
have received drawing by result are reviewed
Page 11 of 34 Technical Supplier Manual
Issued date : dd/mm/yyyyTo : From : Tokai Eastern Rubber (Thailand), Ltd.
Attn : Ms. Suthasri Suwannasri
Position : Position : Technical Staff
Dept. Dept. Technical
Tel. No.: CC : Ms. Maneerat / Technical Dept. Senior Staff
Model :
① Supplier Confirm Sheet
วันทีเ่ขามารับ ………………………………………….……... เวลา 09.30 - 16.00 น. สถานที ่ TER / ESIE
กรุณาเซ็นตรับทราบ และตอบกลบัเอกสารมายัง Fax: (038)-927594 หรือ E-mail: s.suthasri@ter.co.th
ภายในวันท่ี........................................... โดย Supplier จะตองกรอกขอมูลในสวนที ่2 ใหครบถวน
รับทราบ ……………………………………………….
วันที ่………………………………………………......
② List Engineering Drawing / Confirm Submittion Date
Inspection Standard
1 XXXXX-XXXXX XXXXXXXXXXXXXXX XX-XXX A T-XXXX dd/mm/yyyy dd/mm/yyy
2 XXXXX-XXXXX XXXXXXXXXXXXXXX XX-XXX A T-XXXX dd/mm/yyyy dd/mm/yyy
หมายเหต:ุ Supplier จะตองทําการยืน่เอกสาร Inspection Standard ภายในวันเวลาทีกํ่าหนด
หากมีขอสงสยัประการใด กรุณาตดิตอ : คณุนิลบุล เจียมประสตูร / คณุมณีรัตน แสงสงัข / คณุสธุาส ี สวุรรณศรี
เบอร 038-927-500 ตอ 601, 602, 630 E-mail: j.nilubon@ter.co.th, s.maneerat@ter.co.th, s.suthasri@ter.co.th
โดยสงถึงคณุนิลบุล เจียมประสตูร แผนกเทคนิคคอล
No. Part No. Part Name MFG.No
dd/mm/yyyy
dd/mm/yyyy
List of Engineering Drawing to Supplier
** Supplier จะตองกรอกขอมูลใหครบถวน
Submittion Due DateDrawing Effective Date
Level ECI.No.** 1st Lot
(กรุณาระบุวันท่ีสําหรับ 1st Lot)
TER Supplier
( ) ( )
ผูรับคนื/ผูสง ผูรับ
วันที่ วันที่
xxxxxxxxxxxxxMr. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx(0xx)xx-xxxx
xxxxxxxxxxxxxxxxxxxx
dd/mm/yyyy
dd/mm/yyyy Supplier Confirm Receive date
Supplier Confirm Firt Old ECI
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Supplier Quality Improvement Manual
4.4.2.3 Engineering Change Documents (ECR, PCR and Deviation)
Supplier shall have any authorized engineering change documents for those changes
not yet recorded in the design record but incorporated in the product, part or tooling.
4.4.2.4 Customer Engineering Approval (Inspection Standard and Record)
Where specified by TER, supplier shall have evidence of TER engineering approval. (TER's format )
4.4.2.5 Process Flow Diagrams
Supplier shall have a process flow diagram in a supplier-specified format that clearly
describes the production process steps and sequence, as appropriate, and need specified TER needs,
(e.g., Advanced Product Quality Planning and Control Plan reference manual).
Page 12 of 34 Technical Supplier Manual
TER's signature
TER's signature
<Engineering Standard> <Engineering Recorder>
10
* ECR (Engineering Change Reques)* PCR (Process Change Request)
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Supplier Quality Improvement Manual
Note: Process flow diagrams for "families" of similar parts are acceptable if the new parts have
been reviewed for commonality by the supplier.
4.4.2.6 Process FMEA
Suplier shall develop a Process FMEA in accordance with, and compliant to, TER-
specified requirements, (e.g., Potential Failure Mode and Effects Analysis referance manual).
Supplier must undertake efforts to reduce this calculated risk through corrective action
and preventive action
1. RPN more than 128
or 2. The highest RPN
After action will evaluate RPN again
Remark : Refer to Potential Failure Mode and Effects Analysis Manual 4th edition
Page 13 of 34 Technical Supplier Manual
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4.4.2.7 Control Plan
Supplier shall have a Control Plan that defines all methods used for process control and
complies with TER-specified requirements, (e.g., Advanced Product Quality Planning and Control
Plan reference manual). Use TER format
Note: Control Plan for "families" of similar parts are acceptable if the new parts have been
reviewed for commonality by the supplier.
4.4.2.8 Measurement System Analysis Studies
Supplier shall have applicable Measurement System Analysis studies, e.g. gage R&R,
bias, linearity, stability, for all new or midified gages, measurement, and test equipment.(Measurement
Systems Analysis reference manual)
G.R&R technique and/ or Hypothesis test use to analyze measurement system.
Guideline for acceptance of G.R&R
Page 14 of 34 Technical Supplier Manual
% R&R Value Judge
Under 10% Measurement system is acceptable
10% to 30% Acceptable based upon importance of application,
cast gage, cost of repairs.
Needs comment in result and approve by QA Mgr.
Over 30% Measurement system needs improvement.
Supplier Quality Improvement Manual
4.4.2.9 Dimensional Results
Supplier shall provide evidence that dimensional verifications required by the design
record and the control plan have been completed and result indicate compliance with specified
requirements. The supplier shall have dimensional results for each unique manufacturing process, e.g.,
cells or production lines and all cavities, molds, patterns or dies. The supplier shall record, with the
actual results: all dimensions (except reference dimensions), characteristics, and specifications as noted
on the design record and control plan.
Supplier shall indicate the date of design record, change level, and any authorized
engineering change document not yet incorperated in the design record to which the part was made. The
supplier shall record the change level, drawing date, supplier name and part number on all auxiliary
documents (e.g., supplementary layout results sheets, sketches, tracings, cross sections, CMM
inspection point results, geometric dimensioning and tolerancing sheets, or other auxiliary drawings used
in conjunction with the part drawing).
Page 15 of 34 Technical Supplier Manual
※ D4 = 3.27 for 2 trials and 2.58 for 3 trials. UCLR represents the limited individual R's.Circle those that arc beyond this limited.Identify thecause and correct.Repeat these reading using the same appraisers and unit as originally used for discard value and re-average and recomputeR and the limiting value from the remaining observation.% R&R Value Judge Recomment Action Tokai Eastern Rubber (Thailand), LtdUnder 10% Measurement system is acceptable Detail Due PIC
10% to 30% Acceptable based upon importance of application, 1
cast gage, cost of repairs. 2
Needs comment in result and approve by QA Mgr. 3
Over 30% Measurement system needs improvement. 4
CheckedApproved
Supplier Quality Improvement Manual
The supplier shall identify one of the parts measured as the master sample.
4.4.2.10 Material, Performance Test Results, Supplier Chain
The supplier shall have records of material and/or performance test results for tests
specified on the design record or control plan
Material test results shall indicate and include :
-the design record change level of the parts tested;
-any authorized engineering change documents that have not yet been incorporated in the
design record;
-the number, date, and change level of the specifications to which the part was tested;
-the date on which the testing took place;
-the quantity tested;
-the actual results (Attach with test result from laboratory) ;
-Mill sheet
-Supply chain check sheet
-Material List & Component Parts
Page 16 of 34 Technical Supplier Manual
Dimension ResultsSupplier Name : Part No. : Revision :
Part Name : E.C.I. No. :
Stage : Test Date : Test Quantity :
1 2 3 4 5 X R 1 2 3 4 5 X R
①
②
③
④
⑤
⑥
⑦
⑧
⑨
Judge Judge
Supplier Measure TER Measure
ResultTestEquipment
ResultSpecificationTest Item
Supplier Quality Improvement Manual
Mill Sheet
Supply Chain Check Sheet
Material List & Component Parts
Page 17 of 34 Technical Supplier Manual
Supplier Quality Improvement Manual
Performance test results shall indicate and include :
-the design record change level of the parts tested;
-any authorized engineering change documents that have not yet been incorporated in the
design record;
-the number, date, and change level of the specifications to which the part was tested;
-the date on which the testing took place;
-the quantity tested;
-the actual results (Attach with test result from laboratory);
4.4.2.11 Initial Process Studies and Control
The level of initial process capability or performance shall be determined to be acceptable
prior to submission for all special characteristics designated by TER or supplier. The supplier shall obtain
TER concurrence on the index for estimating initial process capability prior to submission.
The supplier shall perform measurement system analysis to understand how
measurement error affects the study measurements.
Note: For characteristics that can be study using X-bar and R charts, a short term study should
be based on a minimum of 25 subgroups containing at least 100 readings from consecutive
parts of the significant product run.
Acceptance Criteria for Initial Study
Index > 1.67 The process currently meets the acceptance criteria.
1.33 < Index > 1.67 The process maybe acceptable. Contact the authorize TER
representative for a review of the study results.
Index < 1.33 The process does not currently meet the acceptance criteria.
Contact the authorize TER representative for a review of the study
results.
Page 18 of 34 Technical Supplier Manual
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After 2nd SPTT audit, supplier will launch to intial process control. Supplier shall record
key process characteristic and key product characteristic as SPC data. The record shall report to TER
for 3 months or 30 production lots by 1 time per month or appropriate period which accept by TER.
4.4.2.12 Qualified Laboratory Documentation
The qualified laboratory (internal or external to the supplier) shall have a laboratory scope
and documentation showing that the laboratory is qualified for the type of measurements or tests
conducted.
When an external/commercial laboratory is used, the supplier shall submit the test
results on the laboratory letterhead or the normal laboratory report format. The name of the laboratory that
performed the tests, the date(s) of the tests, and the standards used to run the tests shall be identified.
4.4.2.13 Master Sample
The supplier shall submit sample product 3 pcs. or 3 shots and retain a master sample
for the same period as the production part approval records, or
-until a new master sample is produced for the same part number for TER approval
-where a master sample is required by the design record, control plan or inspection
criteria, as a reference and standard. The master sample shall be identified as such, and shall show TER
approval date on the sample. The supplier shall retain a master sample for each position of a multiple
cavity die,mold,tool or pattern,or production process.The master sample will attached with full lay out data.
Page 19 of 34 Technical Supplier Manual
Supplier Quality Improvement Manual
4.4.2.14 Checking Aids
The supplier shall submit any part-specific assembly or component checking aids. The
supplier shall certify that all aspects of the checking aid agree with part dimensional requirements. The
supplier shall document all released engineering design changes that have been incorporated in the
checking aid at the time of submission. The supplier shall provide for preventive maintenance of any
checking aids for the life of the part.
4.4.2.15 Records of Compliance with Customer-Specific Requirements
The supplier shall have records of compliance to all applicable TER-specific requirement.
4.4.2.16 Part Submission Warrant (PSW)
Upon completion of all PPAP requirements, the supplier shall complete the Part
Submission Warrant(PSW).
If production parts will be produced from more than one cavity, mold, tool,die, pattern,
or production process, the supplier shall complete a dimensional evaluation on one part from each.
The specific cavities, molds, line, etc., shall then be identified in the "Mold/Cavity/production Process"
line on a PSW, or in a PSW attachment
Note: One warrant per customer part number
Page 20 of 34 Technical Supplier Manual
SUPPLIER XXXXXXXXXXXXXXXXXXXXXXXXXXX
MFG.NO. XXXXXXXXXPART NAME XXXXXXXXXXXXX
PART NO. XXXXXXXXXX NEW
MODEL XXXXXXXX CHANGE
DATE XXXXXXXX RENEWAL
DESCRIPTION & SKETCH : LOT NO. :XXXXXX
MAKER : TOKAI EASTERN RUBBER (THAILAND) , LTD.APPROVED CHECKED
SUPPLIER : XXXXXXXXXXXXXXXXXXAPPROVED APPROVED CHECKED ISSUED
MASTER SAMPLE TAG
FRONT VIEW SIDE VIEW
Supplier Quality Improvement Manual
4.4.2.17 Certification of Non-Use of the controlled substances.
Certification of Non-Use of the controlled substances is the document for supplier certify
the non-use of the controlled substances in process of supplier which produce production material to TER.
Certified with test report or ICP data.
Certification of Non-Use of the controlled substances
Page 21 of 34 Technical Supplier Manual
TOKAI EASTERN RUBBER (THAILAND), LTD.
Supplier name :
Supplier code :
Responsible person name :
Responsible Division/Dept. :
Part no./ Part name:
This is to certify that , these material/ products which were delivered to TER did not contains ;
1. Cadmium and cadmium compounds 13. Organic tin compounds
2. Lead and lead compounds 14. Asbestos
3. Mercury and mercury compounds 15. Azo compounds
4. Hexavalent chromium compounds 16. Formaldehyde
5. Polychlorinated biphenyls (PCB) 17. Polyvinyl chloride (PVC) and PVC blends
6. Polychlorinated naphthalenes (PCN) 18. Perfluorooctane sulfonate anion (PFOS)
7. Polychlorinated terphenyl (PCT) 19. Recycled material
8. Chlorinated paraffins (CP) 20.Polycyclic Aromatic Hydrocarbon(PAHs)
9. Other chlorinated organic compounds 21.Trinuvin 320
10. Polybrominated biphenyls (PBB) 22.Dimethylfumarate ( DMF )
11. Polybrominated diphenylethers (PBDE) 23.REACH(SVHC)
12. Other brominated organic compounds 24. Other
* Remark:For REACH refer to the European Chemical Agency has announced the latest SVHC Candidate List -
please see information from UK. The summary of the obligations is available on ECHA's website.
Put a check in this box if applicable chemical substances are used are no used
If use that substances, what item do you use (1 to 24) ?
If use that substances, when change to no use ?
For Technical of TER
Received by Approved by
Date Date
Supplier Tech (TER) Tech Manager <Attached Sheet 19>Remark : Supplier shall submit this format together with PPAP
Certification of non-use of the controlled substances(for initial parts)
Date
(date/ month/ year)
Approved by
(Manager or higher)
334
334
334
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4.4.2.18 Cover sheet and Test report
4.4.2.19 Material Data Sheet
Material Data Sheet is the document which show and calculate ingredient or
use of substance.
4.4.2.20 Declaration of no use of PFOS
Declaration of no use of PFOS is the document for declaration of no use of PFOS
in your product and material.
Page 22 of 34 Technical Supplier Manual
Cover sheet Test report
Material Data Sheet
Measured Component Component Part Component Material Name Material No. / Symbol Material Norms/Standard Material Weight (g) Material Classification Basic Substance Percentage of SoC/ EHS SoC/ EHS Substance
Weight Part/Item No. Measured Weight Part Or Or Inhouse Norm Surface Treatment (Select from sheet of Name Basic Substance Substance Name Purpose of Use
per Items (g) per Item (g) Quantity Surface Treat. Name Surface Treat. Code Surface Treat. Standard Weight (mg) Material Classification) %
Delivery Part Material SoC/ EHS
Part No. Part Name Component Part Name
Component Part
Supplier Name :
Contact Person : Tel :
Position : Fax :
Dept. : Mobile :
Email:
TOKAI EASTERN RUBBER (THAILAND), LTD.
Issued byChecked byApproved by
Supplier
Attention: Managing Director TOKAI EASTERN RUBBER (THAILAND), LTD.
Signature
Date
Fax
Contact phone no.
Position
Responsible Person’s Name
Responsible Division/ Dept.
Company name
Signature
Date
Fax
Contact phone no.
Position
Responsible Person’s Name
Responsible Division/ Dept.
Company name
I, on behalf of , declare our (Company Name)
delivery products (Including parts, components, direct and indirect Materials) to TOKAI EASTERN RUBBER (THAILAND), LTD. are PerfluorooctaneSulphonate Anion (PFOS) free in accordance with the law and regulation
Declaration of no use of PFOS
(Directive 2006/ 122/ EC).
(Company Name)
Supplier Quality Improvement Manual
4.4.2.21 SVHC Survey
To survey substances of very high concern (SVHC) in product to comply with REACH
regulation.
4.4.3 TER PPAP Status
4.4.3.1 Approved
Approved indicates that the part or material meet all TER requirements. The supplier is
therefore authorized to ship production quantities of the product, subject to releases from TER schedule.
4.4.3.2 Interim Approval
Interim Approval permits shipment of material for production requirements on a limited
time or piece quantity basis. The supplier shall re-submission to TER for status of "Approved" within
7 days after TER reply to supplier.
4.4.3.3 Rejected
Rejected means that the PPAP of supplier does not meet TER requirement. Supplier
shall be corrected to meet TER requirement then submit to TER within 15 days.
4.4.4 Record Retention
PPAP shall be maintained for the length of time that the part is active plus one calendar year.
Supplier shall ensure that the appropriate PPAP records from a superseded part PPAP file are included,
or referenced in the new pat PPAP file.
For (Safety) (Regulation) (Emission) Supplier shall keep the PPAP 11 years
after moldle run out.
Supplier shall keep approved PPAP in paper file and Electronic file (PDF file).
Electronic file shall submit to TER by 7 working days after received PPAP from TER.
Page 23 of 34 Technical Supplier Manual
Accompanying Document Exhibit 2 : SVHC Questionnaire Supplier codeComponents that contain any of the proposed substances listed in Accompanying Document Supplier name in a concentration of 0.1% or more in a homogeneous material or not ? Authority's name( Please add your answer mark in the blank ) Position
Phone no.
If yes please fill in the following table regarding components that contain any of the proposed substances listed in Accompanying Document in a concentration of 0.1%
or more in a homogeneous material. ※If more lines are needed, please add lines as necessary.
a b c d e f
Material Name
Material Standard
Weight of basic material
(homogeneous material)
Concentration of SVHC in homegenious
material (%)Total weight of SVHC Weight of component
12345678910111213
No.SVHC-containing part of component
Part name./Component name.
Part no./Component No.
Name of SVHC
Have
Not have
Company Stamp
S R E10
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4.5 Process Change Requirement
4.5.1 Reason to information of process change and submission requirement for supplier
4.5.1.1 Process Change Notice
Process Change Notice to define change previous process compare with new process for
TER approve. The supplier shall submit Process Change Notice before
change 1 month. (N-1)
4.5.1.2 Sample production parts
The supplier shall provide sample product 3 pcs./shots or all cavity for TER evaluation.
and compare data old with new before approve to Process Change Notice (Before 2 months)
4.5.1.3 Balance Stock Control
Supplier shall to confirm implement timing of change to TER below
N
N-2 -Submit Process Change Notice before 2 months
- Implement timing by forecast
N-1 - Co-Check the Sample production parts before 1 month
D-9 -Stock balance information to TER before 9 days
D-3 -Stock balance information to TER before 3 days
D-1 - Last & First Lot Confirm & Information before 1 day
D - First Lot arrive to TER Implement date
Page 24 of 34 Technical Supplier Manual
Confirm Item Remark
Type
PCN
PPA
P
Proc
ess
Flow
Cha
rt
and
cont
rol p
lan
MSA
Dim
ensi
on R
esul
t
Perf
orm
ance
Res
ult
Supp
ly C
hain
Initi
al P
roce
ss s
tudy
PSW
Sam
ple
Engineering Change from customer O O - - - - - - - -Shape Change O O - - - - - - - -Add/Change Tolerance O O - - - - - - - -Characteristic O O - - - - - - - -Material (Design Change) O O - - - - - - - -
MAN Subcontractor use O - - - - - - O - -Machine add to up capacity (same specification with current machine) O - - - O - - O O O
Machine change (change specification with current machine) O - - - O - - O O O
Process flow chart O - O - - - - O - OControl item I control plan change O - O - - - - O - -Sub-supplier production (Tier3) O - O O O O O O OAdd material sourcing O O - - - - - - - -Change material sourcing O O - - - - - - - -Add mold/die/tooling to up capacity O O - - - - - O - -Change mold/die/tooling O - - - O O - O O OUse tooling which stop production over 12 months O - - - O O - O O O
Checking figure/inspection gauge add O - - O - - - - - OChacking figure/inspection gauge change (design change) O - - O - - - - - O
OTHERS Location change O - - - O - - O - O
Item Cange
Prod
uct
(EC
N)
MEASUREMENT
Mold
MATERIAL
METHOD
MACHINE
Proc
ess
Cha
nge
10
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Supplier Quality Improvement Manual
4.5.2 Delivery requirement after PCN approved.
Supplier shall use initial tag for control shipping parts change to TER follow
Delivery requirement table
Deliver requirement
Last Lot Confirm Change is "Old Part in Last - Attach with Invoise and Part
(Old Parts) ECI" at " Others - Confirm by telephoen / e-mail
First Lot Confirm Change is "New Part Lot - Attach with Invoise and Part
(New Parts) ECI" at " Others - After PSW approved is 1 lot
- Confirm by telephone / e-mail
<Old Part in last ECI tag> < New Part Lot ECI tag>
Page 25 of 34 Technical Supplier Manual
Red
Yellow
RemarkReason / identifyPurposeColor Tag
TO: ARRIVAL DATE : dd/mm/yySUPPLIER : XXX MODEL: XXXX
PART NO. : XX-XXXX-XX MFG. NO. : XX-XXXPART NAME.: XXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Q'TY (Pcs.) XX P/O NO. XX
PART FOR TD0 TM0 TM1 MP Other
Change XXXXXXXXX PCN No. XXXX
DELIVERY BY MR.XXXXX PHONE XXX-XXX
Technical Contact Person IPP Name ESIE
TOKAI EASTERN RUBBER (THAILAND), LTD.Technical
MR.XXXXXXXXXX
TO: ARRIVAL DATE : dd/mm/yySUPPLIER : XXX MODEL: XXXX
PART NO. : XX-XXXX-XX MFG. NO. : XX-XXXPART NAME.: XXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Q'TY (Pcs.) XX P/O NO. XX
PART FOR TD0 TM0 TM1 MP Other
Change XXXXXXXXX PCN No. XXXX
DELIVERY BY MR.XXXXX PHONE XXX-XXX
Technical Contact Person IPP Name ESIE
TOKAI EASTERN RUBBER (THAILAND), LTD.Technical
MR.XXXXXXXXXX
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4.5.3 Change Control Flow
4.5.4 Record Retention
PCN shall be maintained for the length of time that the part is active plus one calendar year.
Supplier shall ensure that the appropriate PCN records are included, or referenced in the past PPAP file.
Page 26 of 34 Technical Supplier Manual
Customer/ TER Supplier
Customer
ManMachineMethodMaterial
Mold/ ToolingMeasurement
Others
TER
Process ChangePart Change
Supplier
ECI Request(Drawing Change)
APQP Team Set up
Master Plan6M Review
Trial
Part and ProcessConfirmation
PCN and DocumentSubmission
1st Shipping to TER
Record
Confirm Shipping
Approve
Trial
PPAP Submit
ECN
Approve
1st Shipping toCustomer
Record
Trial
Inform to Customerby ECR
ECI
Balance Stock
Balance Stock
Cancel PCN
Approved PCN
Review and Approve
Change Information
Confirm ChangeInformation
Review Product and Process
PCN
Cancel PCN
Part and ProcessConfirmation
Document Submission
1st Shipping to TER
Record
Confirm Shipping
ApproveBalance Stock
Balance Stock
N Y
Y
Y
N
Balance Stock
Within 7 Days
D-9, D-3
D-1
Part InformationPCN
APQP Team Review
N
Y
Y
N
D-9, D-3
D-1
N
APQP Team Review Y
Cancel PCN
N Y
N-1Balance Stock
N-1N-2
N-1
N-1
N-2
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Supplier Quality Improvement Manual
4.6 Guideline for Environmental Hazardous Substance Management
4.6.1. Introduction
4.6.1.1 Introduction
According to automotive parts and electronic equipment are commerced to EU market, it is
enforced by ELV, RoHS Directive and REACH regulation. The ELV concept is about "Do not use Lead
Mercury, Cadmium and Hexavalent Chromium for automotive parts (some material / parts are exempted
by Annex II). For RoHS (Restriction of the use of certain Hazardous Substances in electrical and
electronic equipment) is about "Do not use Lead, Mercury, Cadmium, Hexavalent Chromium, PBBs
(Polybrominated Biphenyl) and PBDEs (Polybrominated Diphenyl Ether) for electronic part.
REACH concept is to survey use of SVHC in product.Tokai Eastern Rubber (Thailand), Ltd. have many
supplier that manufacture and deliver raw material / part. It will be finished goods which send to OEM
customer who export the goods to EU market. Then we would like to coorperate with our
supplier in order to establish Environmental Hazardous Substance Management System and protect
contamination of these substances in raw material and product.
4.6.1.2 Purpose
This document is a guideline of quality management for our supplier to comply with it.
4.6.1.3 Scope
This document can apply for all suppliers to prevent Environmental Hazardous Substances
contamination in raw material, part and solution include in-direct material. Supplier will be considered
by supply chain.
4.6.2. Implement
4.6.2.1 Policy/ Objective & Target / Action Plan
(1) Policy/ Objective & Target/ Action Plan is issued by top management. The detail shall
concern activity to decrease Environmental Hazardous Substances. These document shall implement
and review cover organization.
(2) Shall set up training program about Environmental Hazardous Substances for employee.
4.6.2.2 Organization
Shall set up responsible person or team to support management of Environmental Hazardous
Substances in organization. The purpose is to achieve the target.
Note
1 ELV: Directive of End-of-Life vehicles (2000/53/EC)
2 RoHS: Directive of Retriction of the use of certain hazardous substances in electrical and electrinic equipment
(2002/95/EC)
3 REACH: Registration, Evaluation, Authorization and Restriction of Chemicals (Regulation 2006/1907/EC)
4 SVHC: Substance of Very High Concern
Page 27 of 34 Environmental Supplier Manual
*1 *2 *3
*4
Supplier Quality Improvement Manual
4.6.2.3 Communication
(1) Shall set up communication route and information method inside and outside company
about Environmental Hazardous Substances.
(2) Shall have procedure for report to top management and customer when Environmental
Hazardous Substances are found in raw material, part and product.
4.6.2.4 Internal audit
(1) Shall have internal audit and audit report that contain Environmental Hazardous Substances
item.
(2) Shall set up skill and/ or training of internal auditor.
(3) Shall set up procedure for corrective action from internal audit result.
(4) Shall present internal audit result to top management for review performance.
4.6.2.5 Supplier selection
(1) Shall set up supplier selection standard and activity of top management about Environmental
Hazardous Substances with supplier.
(2) Shall set up / inform analysis method of Environmental Hazardous Substancess to supplier.
4.6.2.6 Supplier management
(1) Shall set up plan to monitor Environmental Hazardous Substances at supplier
manufacturing site.
(2) Shall inform supplier about Environmental hazardous Substances control and standard.
4.6.2.7 Receiving raw material
(1) Shall have standard for raw material and part receiving. The standard have to contain
Environmental Hazardous Substances item in check sheet and keep record of it.
(2) Shall have standard for material receiving / distribution from Warehouse and record it
such as lot number.
(3) Shall have analysis result of Environmental Hazardous Substances of raw material.
(4) Shall have method to prevent contamination of Environmental Hazardous Substances in
receiving area.
4.6.2.8 Production
(1) In case of using same equipment/ machine with other customer, production shall have
method to prevent Environmental Hazardous Substances contamination when change raw material.
(2) Shall have procedure for protection of wrong material using.
(3) Shall not use recycled material.
Page 28 of 34 Environmental Supplier Manual
Supplier Quality Improvement Manual
4.6.2.9 Shipping
(1) Shall have supplier history record about lot no.
(2) Shall have procedure for stop shipping raw material when Environmental Hazardous
Substances are found.
(3) Shall have procedure for protection of product mixing.
4.6.2.10 Prevention of re-occurrence
(1) Shall have preparation to protect Environmental Hazardous Substances contamination.
It shall find root cause to protect re-occurrence.
Reference TER's customer requirements
Requirement
The Environmental Hazardous Substances shall not be used for material/part, in-direct & sub-material
which are delivered to TER according to EU Directive 2000/53/EC.The amendment on a regular basis
shall be obeyed, regarding Annex II (2005/673/EC) for automotive part and RoHS Directive 2002/95/EC
for electronic part. All products must be free from Perfluorooctane Sulfonates in accordance
with laws and regulation Directive 2006/122/EC, and REACH Regulation (Regulation 2006/1907/EC)
for chemical.
Supplier' s Responsibility
(1) Supplier shall fulfill all requirements that contained in this manual regardless if is mentioned
in the drawing or not.
(2) Supplier shall fulfill the latest version for amending of the related directives, laws regulations etc.
(3) In case of use of Environmental Hazardous Substance can not be avoided, supplier shall
report to Technical and Purchasing of TER.
Standard of environmental hazardous substances control
Environmental Hazardous Substance Control Flow
TER Supplier
Technical
Technical
Technical
Technical
QA
In case of change : When supplier have change, shall consider environmental hazardous substance which may be effect to
material/part which are sent to TER. Supplier shall submit test report of environmental hazardous substance to Technical section of TER.
Page 29 of 34 Environmental Supplier Manual
Flow In charge Document
Request new material/part
Trial new material/part
Approve PPAP
Start Mass Production
New Part Notice
SBSC (at TM0stage)
- Test reporrt (ICP Data) + Cover sheet - Certificate of non-use of the controlled substances- Declaration of no use of PFOS- Material Data Sheet + Mill sheet/certificate- SVHC survey sheet- PPAP
PPAP
- Certificate of non-use of the controlled substances- Mill sheet- Test reporrt (ICP Data) + Cover sheet (annual)
10
Submit PPAP
Supplier Quality Improvement Manual
Standard for environmental hazardous substances control
In case of unintentional using
Table 1 Criteria of environmental hazardous substances for metal, rubber, chemical which use for
automotive parts
Table 2 Criteria of environmental hazardous substances for rubber, chemical which use for
electronic parts
Remark: Cr6+ Criteria for rust preventive plating part (for TM, JT, DR, DT part) and criteria for reference
is less than 300 ppm by use method prEN 15025 for testing.
: Preparation of PFOS must be less than 50 ppm
Reference
TER' s customer requirements
Page 30 of 34 Environmental Supplier Manual
In case of found environmental hazardous substances
intentional use unintentional use
inform top management and customercompare with criteria at Table 1, 2
And Annex II
acceptover than criteria
inform top management and customer
Corrective action such aschange raw material, change chemical
change process
re-submit PPAP to TER Corrective action such aschange raw material, change chemical
change process
submit PPAP to TER
Pb Hg Cr6+ Cd PFOS
100 100 100 50 1000
ppm max ppm max ppm max ppm max ppm max
Criteria for reference
Pb Hg Cr6+ Cd PBBs, PBDEs ChlorinatedParaffin PFOS
100 100 100 50 None None 1000
ppm max ppm max ppm max ppm max ppm max ppm max ppm max
Criteria for reference 5 NoneNoneNone
less than
Supplier Quality Improvement Manual
Analytical method of Environmental Hazardous Substances
There are 2 types of analysis methods, having different purposes.
(1) Qualitative analysis
The qualitative analysis is the method for determining with each whether a substance of
environmental concern is contained. Basically, the methods specified in Table 1 shall be used.
The main purpose of this analysis is to examine whether there is a content of a substance of
environmental concern in production materials, production trial materials and products. If no such
substances are detected, it means that there is no substances of environmental concern.
Table 1 Qualitative Method and Lower Limit if Detection Level
Cadmium - Fluorescent X-ray method - when measured with magnified
Lead/ Mercury (ED-XRF) detection ability, a signal
intensity level of the concerned
element shall be approximately
3 times the fluctuation of
background intensity (S/B ration
shall be approximately 1/1)
Hexavalent chromium - Colorimetric testing paper(1) - The lower limit of the detection
(Colourometric analysis using level when using a colorimetric
diphenyl carbazide) testing paper shall be such that
the color corresponding to the
corresponding to the color that
indicates the minimum
concentration on the testing
paper can be visually identified.
Note (1); Pack test: KYORITSU CHEMICAL-CHECK Lab., Corp.
(2) Quantitative analysis
The quantitative analysis is the method for accurately determining the amount of a substance, in
order to quantitatively prove that the amount of the substance is equal to or less than the threshold value.
Table 2 shows the analysis method and the lower limit of determination amount for each substance.
However, other quantitative methods may be used instead as long as the method assures the
accuracy of measured value with use of a standard sample and a standard substance, and satisfies
a lower-limit determination amount as specified in Table 2.
Page 31 of 34 Environmental Supplier Manual
Controlled elements Analysis method Lower limit of detection level
Supplier Quality Improvement Manual
Table 2 Quantitative Method and Lower Limit of Determination Amount
amount (ppm)
Cadmium - Inductively coupled plasma atomic
Lead/ Mercury emission spectrometry (ICP-AES)
- Atomic absorption
spectrophotometry (AAS)
Hexavalent chromium - Colourometric analyses using
diphenyl carbazide
Outline of Analysis
The outline of the analyses shall be as shown.
Analytical Instruments
(1) ICP - AES analytical instrument
An instrument comprising an excitation power supply unit, sample injection unit, atomic
emitting unit , spectrometer, device control system, and recorder. It is desirable to use an
instrument equipped with a device for producing atomic vapor by reduction (for Mercury) as an
auxiliary instrument.
(2) AAS analytical instrument
An instrument comprising a light source unit, sample atomization unit, wavelength selection
unit, measuring unit, and data display / recording unit. It is desirable to use an instrument equipped
with auxiliary instruments such as device for producing atomic vapor by reduction (for Mercury)
and electrothermal type furnace.
(3) Absorption photometer
An instrument comprising a light source unit, wavelength selection unit, sample chamber,
measuring unit, and data display/ recording unit.
(4) Fluorescent X-ray spectrometer
An analytical instrument comprising an X-ray generation unit , spectrometer / detector /
proportional counter, data processing unit. Basically, for qualitative analysis, an energy dispersive
type instrument with less restrictions on sample surface shapes shall be used. Further , the
instrument shall be capacle of exciting targeted elements by means of X-ray that prevents detection.
Page 32 of 34 Environmental Supplier Manual
Lower limit of determination
10
50
Controlled elements Analysis method
Materials/ parts
Qualitative analysis
Reporting of nodetection
Quantitative analysis
Reporting measured value
Controldivision
Not detected
Detected
Supplier Quality Improvement Manual
4.7 Control of Initial Nonconforming Products(NC)
To determine supplier responsibility for control and make corrective action in initial nonconforming
product. Nonconforming product is the production part from supplier which their specifications do not
reach engineering drawing and related standard.
Nonconforming Product divided to 2 cases
-Major NC : NC effect to part functional
-Minor NC : NC not effect to part functional
When Technical found NC which occur in supplier process, Technical and supplier shall action
follow this step.
Control of Initial Nonconforming Products(NC) Flow Chart
TER Problem Follow Up Sheet
Note: When Technical found NC may effect to quality score in TER Initial Technical Control(TITC) refer
to TITC criteria.
For special control of initial part, supplier shall take activity QRE (Quality Resident Engineering)
3 months or 30 supplier's production lot. Supplier shall inspect part whice supplied to TER before use
in TER's production process, record for inspection result and identified on delivery tag is "QRE Passed"
Criteria for QRE Approve No major case in part function
Minor case in appearance less than 0.05 ppm
Page 33 of 34 Technical Supplier Manual
Technical/TER found NC part
Issue Quality Information(QI)
Judgement
Major NC Minor NC
QA/TER issue CAR Technical/TER issue Problem follow up sheet
Supplier analyze and report CAR within 7 days
QA and Technical follow up CAR in
process of supplier
Technical follow up Problem follow up sheet
in process of supplier
Supplier analyze and report Problem follow up sheet within 7 days
CAR closing Problem follow up sheet closing
Accept Accept
Not accept Not accept
10
Supplier Quality Improvement Manual
5. Attachment list
Attached Sheet No.1 : Project Organization Chart
Attached Sheet No.2 : Production Preparation Schedule : PPS
Attached Sheet No.3 : List of Engineering drawing of supplier
Attached Sheet No.4 : SPTT Audit Report
Attached Sheet No.5 : MSA format
Attached Sheet No.6 : Shipping Tag
Attached Sheet No.7 : List of Engineering Change
Attached Sheet No.8 : Process Flow Diagram
Attached Sheet No.9 : Control Plan
Attached Sheet No.10 : Dimension Results
Attached Sheet No.11 : Material Test Results
Attached Sheet No.12 : Supply Chain Database List
Attached Sheet No.13 : Material List & Component Parts
Attached Sheet No.14 : Performance Test Results
Attached Sheet No.15 : Initial Master Sample Tag Format
Attached Sheet No.16 : Supplier PPAP request sheet
Attached Sheet No.17 : Part Submission Warrant(PSW)
Attached Sheet No.18 : Supplier Banned Substance Check Sheet (SBSC)
Attached Sheet No.19 : Certification of Non-Use of the Controlled Substances
Attached Sheet No.20 : Process Change Notice
Attached Sheet No.21 : Quality Problem follow up sheet
Attached Sheet No.22 : Environmental test report cover
Attached Sheet No.23 : Material Data Sheet
Attached Sheet No.24 : Declaration of no use of PFOS
Attached Sheet No.25 SVHC Survey
Attached Sheet No.26 Inspection Standard and Inspection Record
Attached Sheet No.27 Allowed maker <Making paint list free SoC>
Page 34 of 34 Technical Supplier Manual
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1 Quality assurance ideality 1 Quality assurance ideality 1 Quality assurance ideality
2 Purpose 2 Purpose 2 Purpose
3 Scope 3 Scope 3 Scope
4 Requests to supplier 4 Requests to supplier 4 Requests to supplier
4.1 Responsibility for Quality and delivery 4.1 Responsibility for Quality and delivery 4.1 Initial Control Organization
4.2 SPTT activity 4.2 SPTT activity 4.2 Approval Initial Part for Supplier
4.2.1 Supplier SPTT Organization 4.2.1 Supplier SPTT Organization 4.2.1 Production Preparation Schedule (PPS)
reponsibility, mobile phone, e-mail
4.2.2 Approval Initial Part for Supplier 4.2.2 Approval Initial Part for Supplier 4.2.2 SPTT activity
New approval flow
4.2.2.1 Production Preparation Schedule (PPS) 4.2.2.1 Production Preparation Schedule (PPS)
4.2.2.2 SPTT activity 4.2.2.2 SPTT activity
4.2.2.3 Inspection Standard 4.2.2.3 Inspection Standard 4.2.3 Supplier Inspection standard
inspection SC rank
4.2.4 SBSC
4.3 Delivery 4.3 Delivery 4.3 Initial Delivery Control
Last lot & First Lot of PCN control
4.4 PPAP Activity 4.4 PPAP Activity 4.4 PPAP Activity
4.4.1 Reason to submit PPAP 4.4.1 Reason to submit PPAP 4.4.1 Reason to submit PPAP
4.4.2 PPAP Retention/Submission Requirement forSupplier
4.4.2 PPAP Retention/Submission Requirement forSupplier
4.4.2 PPAP Retention/Submission Requirement forSupplier
Fix TER format Production material typeEngineering drawing to supplier sheet
- - 4.4.2.1 Supplier PPAP request sheet 4.4.2.1 Supplier PPAP request sheet
Submit Criterial : Production Material
4.4.2.1 Design Record 4.4.2.2 Design Record 4.4.2.2 Design Record
Engineering drawing to supplier sheet extend the detail and format
4.4.2.2 Engineering Change Documents 4.4.2.3 Engineering Change Documents 4.4.2.3 Engineering Change Documents
Engineering drawing to supplier sheet extend the detail and example
4.4.2.3 Customer Engineering Approval 4.4.2.4 Customer Engineering Approval 4.4.2.4 Customer Engineering Approval
extend the detail and format
4.4.2.4 Process Flow Diagrams 4.4.2.5 Process Flow Diagrams 4.4.2.5 Process Flow Diagrams
4.4.2.5 Process FMEA 4.4.2.6 Process FMEA 4.4.2.6 Process FMEA
Refer to 4th edition Established standard for preventive/corrective action
4.4.2.6 Control Plan 4.4.2.7 Control Plan 4.4.2.7 Control Plan
4.4.2.7 Measurement System Analysis Studies 4.4.2.8 Measurement System Analysis Studies 4.4.2.8 Measurement System Analysis Studies
Criteria
4.4.2.8 Dimensional Results 4.4.2.9 Dimensional Results 4.4.2.9 Dimensional Results
Format revise
4.4.2.9 Material, Performance Test Results,Supply Chain 4.4.2.10 Material, Performance Test Results,Supply Chain 4.4.2.10 Material, Performance Test Results,Supply Chain
4.4.2.10 Initial Process Studies 4.4.2.11 Initial Process Studies 4.4.2.11 Initial Process Studies
4.4.2.11 Qualified Laboratory Documentation 4.4.2.12 Qualified Laboratory Documentation 4.4.2.12 Qualified Laboratory Documentation
4.4.2.12 Master Sample 4.4.2.13 Master Sample 4.4.2.13 Master Sample
4.4.2.13 Checking Aids 4.4.2.14 Checking Aids 4.4.2.14 Checking Aids
4.4.2.14 Records of Compliance with Customer-SpecificRequirements
4.4.2.15 Records of Compliance with Customer-SpecificRequirements
4.4.2.15 Records of Compliance with Customer-SpecificRequirements
4.4.2.15 Part Submission Warrant (PSW) 4.4.2.16 Part Submission Warrant (PSW) 4.4.2.16 Part Submission Warrant (PSW)
4.4.2.16 SBSC, Certification of Non-Use of the ControlledSubstances
4.4.2.17 SBSC, Certification of Non-Use of the ControlledSubstances
4.4.2.17 SBSC, Certification of Non-Use of the ControlledSubstancesformat change by not separate initial /mass production
4.4.2.17 - 4.4.2.18 - 4.4.2.18 -4.4.2.18 - 4.4.2.19 - 4.4.2.19 -
4.4.2.19 - 4.4.2.20 - 4.4.2.20 -4.4.2.20 - 4.4.2.21 - 4.4.2.21 -
4.4.3 PPAP Status 4.4.3 PPAP Status 4.4.3 PPAP Status
4.4.3.1 Approved 4.4.3.1 Approved 4.4.3.1 Approved
4.4.3.2 Interim Approval 4.4.3.2 Interim Approval 4.4.3.2 Interim Approval
4.4.3.3 Rejected 4.4.3.3 Rejected 4.4.3.3 Rejected
4.4.4 Record Retention 4.4.4 Record Retention 4.4.4 Record Retention
for PL Law keed the PPAP by PDF file
4.5 Process Change Requirement 4.5 Process Change Requirement 4.5 Process Change Requirement
4.5.1 Reason to information of process change 4.5.1 Reason to information of process change and 4.5.1 Reason to information of process change and
submission requirement for supplier submission requirement for supplier
ECN
4.5.1.1 Process Change Notice 4.5.1.1 Process Change Notice 4.5.1.1 Process Change Notice
4.5.1.2 Sample Product parts 4.5.1.2 Sample Product parts 4.5.1.2 Sample Product parts
- - 4.5.1.3 Balance Stock Control 4.5.1.3 Balance Stock Control
remark
4.5.2 Submission Requirement for Supplier 4.5.2 Delivery requirement after PCN approved 4.5.2 Delivery requirement after PCN approved
Delivery requirement technical control person in tag
4.5.3 Approval process change notice from supplier 4.5.3 Change Control Flow 4.5.3 Change Control Flow
Balance Stock Control
4.5.4 Delivery requirement after PCN approved 4.5.4 Record Retention 4.5.4 Record Retention
4.5.5 Record Retention 4.5.5 - 4.5.5 -
4.6 Control of Initial Nonconforming Products (NC) 4.6 Control of Initial Nonconforming Products (NC) 4.6 Guideline for Environmental Hazardous Substance Management
4.7 Control of Initial Nonconforming Products (NC)
5 TER Initial Technical Control (TITC) 5 TER Initial Technical Control (TITC) 5 Attachment list
6 Attachment list 6 Attachment list format change
Add attachment list 5 Technical Supplier Manual Change Notification
Old Technical Supplier Manual (Rev.9) New Technical Supplier Manual (Rev.9.1)
Technical Supplier Manual Change Notification
New Technical Supplier Manual (Rev.10)
S R E
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