Noratel International (Pvt) Ltd. 8D-Report FO/QA/8.

7/06

Report Complete Date: 2020-10-02 (Rev1: 2020-10-13 ) 8D Initiator: Snr.QA & Env. Engineer
Customer: GE Healthcare Approved by: Manager-QA & Env.
Product No: S-080-000034 Complaint No. C-6575/2020 | 4676
Customer Part Number: 2078042-001 Rev C Complaint Reference: SCAR 26460
Complained Order No.: J095655101-100 (LK1941C) Qty. Delivered: 280
J095695601-100 (LK1943C) 280
J094757401-100 (LK1819C) 64
Quantity Reported: 34 (2020-10-05) Qty. Returned: 6 (2 pcs – LK1941C + 4 pcs - LK1943C)

D1 Establishing the Team:

Function Name
S. QA&E Yedum Karunarathne
QA&E M Audrey Samaraweera
Team S. DE Sarith Charuka
E&CR M Deepal Wijesinghe
Members:
S. DE Pahan Aberathne
OM Jalaka Wickramasinghe
QA&E Sajith Ranatunge
Sales E. Binju Alexander
D2 Problem Description & Analysis:
Customer Faulty Description: Loud Noise coming out from the transformer
Observations & Analysis Findings of Returned Samples

• 6 field returned samples were used for the analysis.

Serial Numbers:
SN 02260 (LK1941C), SN 02268 (LK1941C), SN 02767 (LK1943C), SN 02800 (LK1943C), SN 02796 (LK1943C),
SN 02762 (LK1943C)

• Past electrical test records were checked & confirmed that all products had been passed the no load
electrical tests before delivering them from Noratel Sri Lanka.
Refer attachments:
Attachment 1: Past Electrical Test Records of Field Retuned Samples

• In BH graphs (Magnetic Hysteresis Loops), if there is no significant increase in flux (B) against the increases
in magnetizing force (H), the transformer is driven to Saturation region. BH graphs (Magnetic Hysteresis
Loops) were obtained for the returned samples & confirmed that transformers were not reached to the
saturation.

Refer attachments:
Attachment 3: BH waveforms (Magnetic Hysteresis Loops) at 50 Hz & 60 Hz.

• An abnormal noise was heard in all field returned samples. The abnormal noise was generating from the E
laminations & I laminations joint in all samples.
• Noise values were recorded in different voltages at no load condition after the products were powered
under rated load condition & 253 V/ 50 Hz overvoltage condition.
Refer attachments:
Attachment 4: Noise Test Results of field returned samples

• Varnish penetration level & curing condition (Dry, had & tack free) were checked between the E & I joint
after cutting down the field returned samples.
Refer attachments:
Attachment 5: Varnish penetration level & curing condition of field returned samples
Date of Issue : 2018-05-30 Revision No : A0 Revision Date : --
This document contains proprietary & confidential information belonging exclusively to Noratel International (Pvt).Ltd.
All Rights reserved
PO Box: 15, Phase II, EPZ, Katunayaka, Sri Lanka
Tel: (+94)0112252300 fax: (+94)0112259965
 Noratel International (Pvt) Ltd. 8D-Report FO/QA/8.7/06

• When comparing noise test values (Attachment 4) & the area of less varnish penetration in each field
returned transformers (Attachment 5) it can be seen that
➢ If the less varnish penetration area is high the recorded noise level is high.
➢ If the less varnish penetration area is low the recorded noise level is also comparatively low.
• Therefore, it is clear that varnish penetration is causing the abnormal noise generation.

In addition to the field returned product analysis findings three experiments were done to further verify the
analysis findings & narrow down the possible causes for the failure.
Experiment no. 1

• An experiment was done for a high noise product to see the noise level after it was re-varnished using Dip
varnish method. (Varnish Method: Dipping Time - 20 min dipping time, Viscosity - 1000 cP – 3500 cP, Oven
Cycle - 100 0C/ 6 hrs)
• The Product was tested (Test Method: 253V/ 50 Hz overvoltage to input) for 10 hrs.
• After 10 hr testing time the product started to generate the abnormal noise. Refer below table.
Voltage / Before After re-varnishing &
V re-varnishing / dB 10 hrs testing / dB
230 54.6 53.4
253 56.5 56.2

• The varnish penetration level was checked between the E & I portions in this product & it was observed that
there are still some area which has less varnish penetration.

• From this experiment, it is was concluded that a successful penetration is not happened from a second time
Dip varnish since the varnishing shell created from the initial varnish layer is blocking further varnish
penetration to the varnish free areas.

Experiment No. 2
• 5 production samples which were identified as low noise samples during the 253V/ 50 Hz overvoltage test
for 15 minutes, were tested for another 52 hrs. Refer below table.
Sample # Noise after 15 mins / dB After 52 hrs testing / dB
62 47.2 47.3
66 46.5 46.5
67 46.3 46.4
68 45.7 45.9
69 47.4 47.4

Date of Issue : 2018-05-30 Revision No : A0 Revision Date : --

This document contains proprietary & confidential information belonging exclusively to Noratel International (Pvt).Ltd.
All Rights reserved
PO Box: 15, Phase II, EPZ, Katunayaka, Sri Lanka
Tel: (+94)0112252300 fax: (+94)0112259965
 Noratel International (Pvt) Ltd. 8D-Report FO/QA/8.7/06

• The varnish penetration levels of these samples were checked between the E & I portions. The level of
varnish penetration was acceptable in all five samples.
Refer attachment:
Attachment 6: Varnish penetration level between the E & I portions of Low Noise samples.

Experiment No. 3

• Field returned sample SN 2800 was subjected to 130 0C /4 hours oven cycle. 130 0C/ 4 hours is the supplier
given typical oven cycle for Dip varnish (Ultimeg 2000/380).
• Noise levels were compared before & after 130 0C /4 hours oven cycle.
Note: Thermal fuses of primary windings were bypassed during this experiment.
• The varnish curing level was compared with the other field returned samples & a low noise sample.
• The abnormal noise was not reduced even after this oven cycle & there was no noticeable difference in the
varnish curing level when compared to rest of the field returned samples & low noise samples.
Refer attachments:
Attachment 4: Noise Test Results of field returned samples
Attachment 5: Varnish penetration level & curing condition of field returned samples

• From this experiment, it was concluded that the there is no justifiable relationship between the abnormal
noise generation & the varnish curing.

Conclusions

• Based on the above analysis results & the experiments, it can be concluded that the less varnish
penetration between E & I portions is the cause for this abnormal noise generation.
• There is a risk of using two times dip varnishing as a solution for the humming products.

Left / Right Look

• S-080-000035 (2077510-001) is the other design which is supplying for GEHC.

• A field returned transformer from S-080-000035 (2077510-001) were received for analysis due to
abnormal noise / humming. It was analysed & confirmed that the varnish was properly penetrated
between the E & I laminations
Refer attachments:
Attachment 13: Analysis Report S-080-000035

• Three products were randomly picked from the on-going production & checked the varnish penetration
level between E & I lamination joints.
Refer attachments:
Attachment 14: Varnish Penetration Level of S-080-000035

• 253V/ 50 Hz overvoltage test for 15 minutes was done for the ongoing batch from 960063-1/ LK2026C/ 504
pcs. There was no any rejection due to abnormal humming.
• When looking all analysis findings above it can be concluded that this less varnish penetration has not been
caused for the design S-080-000035 (2077510-001).

Date of Issue : 2018-05-30 Revision No : A0 Revision Date : --

This document contains proprietary & confidential information belonging exclusively to Noratel International (Pvt).Ltd.
All Rights reserved
PO Box: 15, Phase II, EPZ, Katunayaka, Sri Lanka
Tel: (+94)0112252300 fax: (+94)0112259965
 Noratel International (Pvt) Ltd. 8D-Report FO/QA/8.7/06

D3 DEFINE AND VERIFY ROOT CAUSE(S): Week: 202037

Defect Occurred Root Cause Analysis:

Problem: Abnormal Noise coming Out from the transformer

Why: Less varnish penetration between the E & I portions
Varnish has not been penetrated through the small gaps between E & I portions due to the
Why: high viscosity of the used varnish
Refer attachment:
Attachment 5 & Attachment 6

The viscosity range of the varnish bath has been shifted to upper limit of the defined
viscosity range from week 201941 to week 201944.
Following batches have completed during this period.
Order Ref / Date Code Batch Qty Serial Number Range
947574-12 (LK1819C) 64 From 002027 To 002090
Why: 956551-1 (LK1941C) 280 FROM 02091 TO 02370
956956-1 (LK1943C) 280 FROM 02571 TO 02850
956551-2 (LK1942C) 200 FROM 02371 TO 02570

Refer attachment:
Attachment 7: Viscosity Records for S-080-000034 & S-080-000035 Orders
Attachment 8: Variation Viscosity Values

Viscosity of varnish bath has been maintained within the defined viscosity range. But, the
defined viscosity range for Ultimeg 2000/380 varnish is too wide.

Why: Defined viscosity range for the vanish bath: 1000 cP (Top) – 6000 cP (Bottom).
Note: This viscosity range was defined by Noratel through an internal evaluation.
Refer attachment:
Attachment 9: Process validation for Dip Varnish – Viscosity Adjustment

• Root cause:
Defined viscosity range for the varnish bath is too wide.

Defect Escape Root Cause Analysis:

Problem: Abnormal Noise coming Out from the transformers were not detected

Why: Noise/Humming test was not performed

Why: Noise/Humming test was not a specified test in the Noratel manufacturing specification

Noise/ Humming level was not a specified parameter in the customer specification
Why: Refer attachment:
Attachment 15: Customer specification for 2078042-001

• Root cause:
Noise/ Humming level was not a specified parameter.

Date of Issue : 2018-05-30 Revision No : A0 Revision Date : --

This document contains proprietary & confidential information belonging exclusively to Noratel International (Pvt).Ltd.
All Rights reserved
PO Box: 15, Phase II, EPZ, Katunayaka, Sri Lanka
Tel: (+94)0112252300 fax: (+94)0112259965
 Noratel International (Pvt) Ltd. 8D-Report FO/QA/8.7/06

Achieved
D4 Containment Action(s): Resp
Week
On-Hand Stock
• On-hand stock of Noratel Power Engineering was tested & verified. NPE 202031
Note: Noratel Power Engineering is a Storage Facility
Number of Rejects: 0 out of 330 products.
Order Ref.:
95856-2/ LK2007C, 95856-3/ LK2007C , 957942-3/LK1950C NOLK 202026

• On-hand stock of Noratel Sri Lanka was tested & verified.

Number of Rejects: 0 out of 180 products.
Order Ref.:
958563-4/ LK2007C

Test Method:
Apply 253V/ 50 Hz overvoltage to primary winding for 15 minutes. (Nominal voltage is
considered as 230 Vac at 50 Hz. The transformer is applied 10% overvoltage input
during this test)
Refer attachments: NOLK 202026
Attachment 10: Verification of 253 V/50 Hz Overvoltage test for 15 min
Acceptance Criteria: Noise level < 55 dB at 253 V.
NOLK 202037
Production Process
• Aware Production line & varnishing section on the customer complaint.

• Viscosity of the dip varnish (Ultimeg 2000/380) bath was maintained 1000 cp (top) – NOLK 202026
6000 cp (bottom). This range was revised to 1000 cp (top) – 3500 cp (bottom).
Starting Order Ref:
961174-2 / LK2035C1

• 253V/ 50 Hz overvoltage test for 15 minutes was implemented for this design & similar
GE designs.
Starting Order Ref:
958563-4/ LK2007C(2078042-001 Rev C), 960063-1/ LK2026C (2077510-001)

NOLK- Noratel Sri Lanka , NPE – Noratel Power Engineering

Planned Achieved
D5 CHOOSE AND VERIFY CORRECTIVE ACTION(S): Resp.
Week Week

S.QA&E 202042
• Change the existing varnishing process as below,
Step 1: VPI (Ultimeg 2000/ 520) varnish will be used as the primary varnish
coating.
➢ Varnishing method: Vacuum Pressure Impregnation (VPI)
➢ Viscosity: 400 cp – 600 cp
➢ Curing Temperature: 120 0C/ 6 hrs
Due to the less viscosity of the varnish & VPI varnishing technique,
varnish penetration capability is increased when using Ultimeg
2000/ 520 varnish.

Date of Issue : 2018-05-30 Revision No : A0 Revision Date : --

This document contains proprietary & confidential information belonging exclusively to Noratel International (Pvt).Ltd.
All Rights reserved
PO Box: 15, Phase II, EPZ, Katunayaka, Sri Lanka
Tel: (+94)0112252300 fax: (+94)0112259965
 Noratel International (Pvt) Ltd. 8D-Report FO/QA/8.7/06

Step 2: Dip (Ultimeg 2000/ 380) varnish will be used as the secondary
varnish coating.
➢ Varnishing method: Dip
➢ Viscosity: 1000 cp – 3500 cp
➢ Curing Temperature: 120 0C / 6 hrs
Due to the high viscosity of the varnish, varnish make a thick layer
of varnish over the outer surfaces of the steel core & this thick
layer prevents the steel core from the rust.
Refer attachments:
Attachment 16: Work Instruction

• Implementing 253V/ 50 Hz overvoltage test for 15 minutes as routing test

for 2078042-001 (S-080-000034), 2077510-001 (S-080-000035) & any S.DE 202042
future EI design for GEHC.

Refer attachments:
Attachment 17: Work Instruction

• Implementing batch wise recording for system for 20 minutes varnish OM 202044
dipping time & 30 minutes varnish dripping time.
Note:
Varnish dipping time is an already specified requirement in the operational
documents. This requirement is currently verified through the QA & Production
random inspections.
Refer attachments:
Attachment 18: Process Flow Chart & Records

Planned Achieved
D6 IMPLEMENT AND VALIDATE CORRECTIVE ACTION(S): Resp.
Week Week

• 30 pcs sample batch was completed using new varnish method (Step 1: VPI
+ Step 2: Dip).
• All products were subjected for 253 V (10% overvoltage) test for 40 hrs. 15
products were subjected for 575 VA load test for 36 hours. Any product
was not rejected due to abnormal noise generation.
• Visual check was done for 30 samples to see the varnish penetration
between E & I portion. Varnish was properly penetrated between the E & S.QA&E 202038 202038
I portions in all products.
Refer attachments:
Attachment 11: Evaluation VPI + Dip varnishing_S-080-000034

Date of Issue : 2018-05-30 Revision No : A0 Revision Date : --

This document contains proprietary & confidential information belonging exclusively to Noratel International (Pvt).Ltd.
All Rights reserved
PO Box: 15, Phase II, EPZ, Katunayaka, Sri Lanka
Tel: (+94)0112252300 fax: (+94)0112259965
 Noratel International (Pvt) Ltd. 8D-Report FO/QA/8.7/06

Planned Achieved
D7 SYSTEM PREVENTION ACTIONS: Resp.
Week Week

• Include the Ultimeg 2000/520 varnish into the UL file UL file E496375. DE 202040 202040
Refer attachments:
Attachment 19: E496375-VolD2-SecD1001-UL Mark Procedure
• Review Operational Procedure & Inspection Procedures to include new QA&E M 202041
process changes related to varnishing process.
Refer attachments:
Attachment 20: Process changes for varnish time tracking system.

• Revise the manufacturing specification of this transformer. S.DE 202042

Refer attachments:
Attachment 17: Specification instruction for 253V/50 Hz overvoltage test.

• Aware new changes to Production line & Varnishing section. S.QA&E 202042
Refer attachments:
Attachment 21: Training Records
Planned Achieved
D8 VERIFICATION OF EFFECTIVENESS: Resp.
Week Week

• 5 pcs sample batch was shipped in week 202040 to GEHC India for approval.
Refer attachments: S.DE 202042
Attachment 12: NOLK Test results of 5 pcs sample order

REMARKS

Should you have any queries please contact us.

Thank you for your cooperation,

Yedum Karunarathne,
Snr. QA&E Engineer

Date of Issue : 2018-05-30 Revision No : A0 Revision Date : --

This document contains proprietary & confidential information belonging exclusively to Noratel International (Pvt).Ltd.
All Rights reserved
PO Box: 15, Phase II, EPZ, Katunayaka, Sri Lanka
Tel: (+94)0112252300 fax: (+94)0112259965