1D - 8D Report A

1. 1D -PROGRESS OF 8D
VENDOR MANAGEMENT 8D REPORT
PROGRESS OF 8D DATE [DDMMYYYY]
QIS ISSUED 15Dec2015
D1 -Team Formation 16/12/2015
D2 -Problem Description 16/12/2015
D3 -Immediate Containment Action 16/12/2015
D4 -Root Cause Analysis 20th Jan 2016
D5 -Corrective Action And Verification 20th Jan 2016
D6 -Preventive Action 20th Jan 2016
D7 -Final Conclusion 20th Jan 2016
D8 -Lesson Learnt 20th Jan 2016
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2. 1D INITIAL INFORMATION FOR SUPPLIER CORRECTIVE ACTION
INITIAL INFORMATION FOR SUPPLIER CORRECTIVE ACTION REQUEST
QIS Ref No : QI-15-12-02
Issued By : Yeo Ai Fang
Issued Date : 15-Dec-2015
Initiator Business Unit : LDHU_
Material Description :
Material / Package :
Type No :
SFL0000640BC
Supplier : ENPLAS HI TECH (SINGAPORE)
Batch No :
151016C193-1
Occurrence Date : 15-Dec-2015
Occurrence Ratio : 4.34% (88/2028 pcs)
Occurrence Stage : In Process
Reoccurence[ Y / N ] : No
Specification : [OS] Out of Specs
Defective Description : HOE LENS STAIN ISSUE
Email Communication Subject :
Outline of concern :
[Highlight additional
concern like impact
to assembly ]
Completion Date 21-Dec-2015
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3. 1D -Team Members
Team Name Position Position
Members:
Kobayashi Hisanobu General Manager 0936.265.104 [email protected]
Bui Thu Ha Manager 0904.885.012 [email protected]
Nguyen Van Truong Assistant Manager 0904.885.025 [email protected]
Bui Van Hien Assistant Manager 0904.885.026 [email protected]
Mai Chi Tien Assistant Manager 0904.885.028 [email protected]
Duong T. Thuy Mai Staff - [email protected]
HuaThi Thuy Staff - -
Lee Kin Nan
Senior Technical
Engineer - [email protected]

4. 2D -PROBLEM DESCRIPTION (DESCRIPTION OF NONCONFORMANCE) (D2)
[Please Provide more detail (e.gPhotograph & Measurement) as
compared to initial information given by Site in 1]
(1) Defect Mode : ENPLAS HOE LEN Stain Issue
(2) Part No : SFL0000640BC
(3) Type No : LNLDHU-HOE7-1AM
(4) Lot No: 151016C193-1
(5) Failure Rate : 4.34% (88/2028 pcs)
(6) Current Stock [UTAC] : 120Kpcs
Problem Description:
UTAC detected HOE Stain issue during AVI . Upon Investigation , the failure was found to be NG with stain.
The affected area are random and the stain are located at functional area and outside functional area
Defect Photo:
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5. 3D . IMMEDIATE CONTAINMENT ACTION.
A. What Containment Action have been taken for current stock? [VI on Finished Goods] :
[Please provide detail of Method being used for the containment Action -eg. Visual Inspection by 20X
Scope / Naked Eye]
Enplasperformed stop delivery, wait return sample for recheck.
Based on appearance standard, we'll re-check all inventory of Enplas
(Vietnam) by Stereo Microscope (over 20 + 5X).
B. What current Stocks were re-inspected?
[Stock in Supplier WIP, Supplier Warehouse, Shipment Route, Customer VMI , Customer
Warehouse ]
Enplasre-checked stock parts: all stock 1172612pcs OK
We did not find the stain defect detect in stock parts.
C. Is there any Kept Sample or Retention Sample being verified for such
failures?
No, There is not any keeping sample being verified for such failures.
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6. 3D . IMMEDIATE CONTAINMENT ACTION.
E. What is the indication being used to indicate the goods that were inspected
or do not have such issue?
Enplaswill stick indication " Re-check stain defect" on all box before
shipping.
F. Based on Supplier's expertise, please state clearly on whether other types
provided to Site is also affected.
Please state to the best of knowledge during the initial investigation till
now.
Enplasperformed checking on others parts, there are no common defects
found on the others types lens which provided to site.
D. Any immediate changes to the assembly process to prevent any more
defectives being produced?
[Eg. Some selected line are stopped or some process are modify
temporarily to continue the production]
Enplaswill stop production and investigate the cause and take
countermeasure
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7. 4D -ROOT CAUSE ANALYSIS PART 1.
4.1 Re-check all inventories
–We re-checked Enplas stock parts: all stock 1172612pcs OK
–We did not find the stain defect detect in stock parts.
A.Please Provide Analysis to find out the CAUSE in whichever format that
Supplier would like to use.
Please provide clear analysis and conclusion that will lead on to the
derivation of the root cause [CAUSE ANALYSIS]Part No Pro. Date Pcs
The stain defect
SFL0000640BC 7,8/2015 1172612 OK
Check the stain defect the sample of inventory
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8. 4D -ROOT CAUSE ANALYSIS PART 1.
4.2 4M Factor Analysis
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9. 4D -ROOT CAUSE ANALYSIS PART 1.
4.3 Hypothesis & Simulation Test
Consideration for the solvent adhesion
The stain can be solvent or solvent stain. 4.2.1) saliva , 4.2.2) Oil, 4.2.3) such as an
adhesive
4.3.1: Consideration for saliva:
From the results of saliva flying reproduction test, There is a tendency to spread
the case of saliva stains
⇒But, In our production process, and thorough the mask worn, We have
conducted a saliva shatterproof (Pic1,2)
We used the swab cleaned dry saliva,
the saliva was take out (Pic. 3)
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10. 4D -ROOT CAUSE ANALYSIS PART 1.
4.3.2) Consideration oil adhesion
⇒Base on confirmed the result of inspection history and the keep-sample , oil
adhesion failure has not been identified.
4.3.3) Consider the adhesive
And the solvent as an adhesive is not used at our all process.
There are stains defect on the lens, It is considered to be adhesive is a product after
use .
'=> The stains defect on the lens likely caused by the adhesive cling
'It believed that there is a high possibility of scattering marks at the time of adhesive
application.
We used the swab cleaned solvent on the part received from customer, it wasn't
take out (Pic.4)
'We'll send sample to Enplas (Japan) for analyze
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11. 4D -ROOT CAUSE ANALYSIS PART 1.
4.5 Recheck stain samples which were returning
from customer.
•Enplasdid visual check for the stain sample which were
returning from customer. (5pcs crack samples)
•Enplasfound there was residue of adhesion around the stain
area which looks like liquid leaking from other area. (Pic.5)
4.6 Result:
From the above survey results. Enplassuspected that the liquid look like materials
may occurred after shipment from Enplas.
Enplaswill continually note confirming dirty solution or Solvent in all its process.
Enplaswould like Utacto investigate any changes in bonding process.
4.4 Confirm whether or not the defect arising the visual inspection
results.
Enplasasked each inspection weather discovered a defect like this phenomenon in the past.
Results showed that this phenomenon does not ever arise in the past.
H.5
4.7 SEM/ EDX result from customer
SEM/ EDX result shows the element of the stain are chlorine, carbon, Patassium, Nitrogen,
Oxygen, Sodium and Silicon.
Analytical results from the customer is on the surface coating of the products. The element of
the stain are coating materials. 11

12. 4D -ROOT CAUSE ANALYSIS PART 1.
B. Please describe in summary the conclusion from A above on the root cause of the
issue. [CAUSE CONCLUSION]
Analyzed result show the stains is dry runny nose (nasal mucus) of human.
4.8) Analyzed results from EVN:
EVN has analyzed the stain on surface product is the stains was dry runny nose (nasal mucus)
of human.
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13. 4D -ROOT CAUSE ANALYSIS PART 1.
C. Please Provide Analysis to find out the reason of ESCAPE in whichever format that
Supplier would like to use.
Please provide clear analysis and conclusion that will lead on to the derivation of the root
cause [ESCAPE ANALYSIS]
At EnplasVietnam has not yet experience and discovered this defect in the past, it is high possibility
the dry nasal mucus arise after appearance inspection process.
D. Please describe in summary the conclusion from C above on the reason of ESCAPE of the
issue.[ESCAPE CONCLUSION]
There are high possibility the dry nasal mucus arise after appearance inspection process.
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14. 4D ROOT CAUSE ANALYSIS PART 2.
Vendor Management Group will inform Supplier on whether the following WHYWHY
Analysis are required for the closure of the report.
The following three Areas of Why WhyAnalysis may have to be performed.
E. Why did we have the specific Problem ? [WHYWHY FOR CAUSE]
Nasal mucus stick on the products arises only after coating process, because if it happened
before coating products, the product will be crack.
May be someone did not the wear the mask, or remove the mask when exposed the
product after coating, so the nasal mucus stick on the products.
So, the nasal mucus stick on the after coating products may happen in our factory.
However, we have the Cleanroom control procedure, everybody understands clearly the
regulation and must compliance with wear the clean room clothing and mask when enter
the cleanroom or exposure to product.
Therefore, the stick of nasal mucus on the product. Likely to happen is low in our
company. Else, may be after delivery, the nasal mucus stuck on the products when
assembly.
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15. 4D ROOT CAUSE ANALYSIS PART 2.
F. Why was the Problem not detected? (Why did the problem reach Customer?) [WHYWHY
FOR ESCAPE]
At EnplasVietnam has not yet experience and discovered this defect in the past, the sticky
nose will arise after appearance inspection process is high. So, we did not detected.
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16. 4D ROOT CAUSE ANALYSIS PART 2.
G. Why did the system fail? (Why did our system allow it to occur) [WHYWHY FOR QMS
SYSTEM]
Our the system not have problem. We have the Cleanroom control procedure, everybody
understands clearly the regulation and must compliance with wear the clean room clothing
and mask when enter the cleanroom or exposure to product (Pls. see Pic4, 5,6)
Pic 4
Regulation of wear clothing Clean room clothing Appearance Inspection
Wear the clean room
clothing and mask
Pic 5
Pic 6
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17. –We informed about to all operator to comply with regulations
when in cleanroom.
5D CORRECTIVE ACTION AND VERIFICATION.
I.Enplas informed about the nasal mucus stick on the products issue to all operators.
(Effective date : From 25
th
Dec 2015)
II.Re-training compliance with proper wear the clean room clothing and mask when enter
the cleanroom or exposure to product. (Effective date : From 28
th
Dec 2015)
III.Enplas will establish prohibitions to talk during products inspection. (Effective date :
From 20
th
Jan 2016)
Re-training compliance with wear the
clean room clothing
Re-training regulation Cleanroom
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Regulation not talk during
products inspection

18. 6D PREVENTIVE ACTION.
QA will periodically check compliance with wear the clean room clothing and mask.
(Effective date : From 20
th
Jan 2016)
We maintain periodic training the Cleanroom management procedure.(Completion date :
December every year)
7D FINAL CONCLUSION.
1)From the above findings, We think there is a high possibility that the runny nose stick
on the products after shipment. Because, We have the Cleanroom control procedure,
everybody understands clearly the regulation and must compliance with wear the clean
room clothing and mask when enter the cleanroom or exposure to product.
2) Could the customers review about compliance with wear the wear a mask in customer's
process?
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19. 8D LESSON LEARN
Re-train compliance with wear the clean room clothing and mask when enter the cleanroom
or exposure to product.
We maintain periodic training the Cleanroom management procedure.(Completion date :
December every year)
The Details Cleanroom management procedure
Periodic training plan of the Cleanroom
management procedure
Periodic Training
Record
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