CERTIFICATION AUDIT REPORTsouthernopto.com/BVQI QMS Audit Report 2018-19.pdf · Recertification...

SOUTHERN OPTOELECTRONICS DEVICES P.LTD

CERTIFICATION AUDIT REPORT

4372044

Bureau Veritas (India) Pvt. Ltd.

(Certification Business)

on behalf of BVC Holding SAS - UK Branch (Address: 5th Floor,

66 Prescot Street, London, E18HG, United Kingdom)

Recertification Audit / ISO 9001:2015

Recertification Audit / ISO 9001:2015 Audit Start Date: 11-02-2019 - Audit End Date: 13-02-2019 - Report completed on:

This report is confidential and distribution is limited to the audit team, the company and the Bureau Veritas Certification office.

SOUTHERN OPTOELECTRONICS DEVICES P.LTD Bureau Veritas (India) Pvt. Ltd.


INDEX

1 GENERAL INFORMATION

1.1 ORGANIZATION INFORMATION

1.2 CONTACT INFORMATION

2 AUDIT INFORMATION

2.1 AUDIT STANDARDS

2.2 SCOPE OF CERTIFICATION

2.3 AUDITOR INFORMATION

2.4 AUDIT SCOPE

- Audit Objectives

- Audit Plan

- General & legal compliance requirements

3 AUDIT PROCESS

3.1 AUDITOR NOTES / SIGNIFICANT AUDIT TRAILS

3.2 DOCUMENT REVIEW

3.3 AUDIT SUMMARY REPORT PER STANDARD

3.4 NON CONFORMITY REPORT

4 PERFORMANCE TO DATE

5 EXECUTIVE AUDIT SUMMARY

5.1 AUDIT CONCLUSIONS

5.2 SUMMARY OF AUDIT FINDINGS

5.3 MANAGEMENT SYSTEM EFFECTIVENESS

5.4 BEST PRACTICES

5.5 UNRESOLVED POINTS ON DIVERGING OPINIONS

6 TEAM LEADER RECOMMENDATIONS

7 SURVEILLANCE PLAN

8 AUDIT PROGRAMME

9 NEXT VISIT AUDIT PLAN

10 Certificate information

This report is confidential and distribution is limited to the audit team, the company and the Bureau Veritas Certification office. Page 1 / 61




1 GENERAL INFORMATION

1.1 ORGANIZATION INFORMATION

Organization Name SOUTHERN OPTOELECTRONICS DEVICES P.LTD

Address No.104, Venkateshpuram , Arabic College Post

City BANGALORE

Postal Code 560045

County/State -

Country India

Phone Nº +9108025476627 Fax Nº

Contract nº 4372044

1.2 CONTACT INFORMATION

Contact Name Prakash Savanur

Email [email protected]

Phone Nº +9108025476627





2 AUDIT INFORMATION

2.1 AUDIT STANDARDS

Audit Standard(s) ISO 9001:2015

Language Scope of Certification

2.2 SCOPE OF CERTIFICATION

Site Name Head

Office

Standard

EN MANUFACTURE OF LED LAMPS, LED

DISPLAYS, POPULATED PCB ASSEMBLIES

AND LED LIGHTING PRODUCTS

HO ✓ISO 9001:2015

Nº of Sites 1

Nº of Employees 85

Head Office HO

If this is a multi-site audit an Appendix listing all the relevant sites and/or remote locations has been established and attached to the

audit report.

Recertification AuditType

Audit Start Date 11-02-2019 Audit End Date 13-02-2019 Duration 3





2.3 AUDITOR INFORMATION

Team Leader Team MembersInitials Initials

NAGARAJU THEJASWINI THN-IN T. V. VARDARAJAN TVV-IN

PRIYADARSANAN KAPPALLIL MADHAVAN PRK-IN





2.4 AUDIT SCOPE

1. To confirm that the management system conforms with all the requirements of the audit standard(s);

2. To confirm that the organization has effectively implemented its planned arrangements;

3. To confirm that the management system is capable of achieving the organization’s policies and objectives and

evaluation of the ability of the management system to ensure the client organization meets applicable statutory, regulatory

and contractual requirements;

4. If applicable to identify areas for potential improvement of the management system.

5. The purpose of the stage 2 audit is to evaluate the implementation, including effectiveness, of the client's management

system.

It shall include at least the following:

a) information and evidence about conformity to all requirements of the applicable management system standard or other

normative document;

b) performance monitoring, measuring, reporting and reviewing against key performance objectives and targets (consistent

with the expectations in the applicable management system standard or other normative document);

c) the client's management system and performance as regards legal compliance;

d) operational control of the client's processes;

e) internal auditing and management review;

f) management responsibility for the client's policies;

g) links between the normative requirements, policy, performance objectives and targets (consistent with the expectations

in the applicable management system standard or other normative document), any

applicable legal requirements, responsibilities, competence of personnel, operations, procedures, performance data and

internal audit findings and conclusions.

Audit Objectives





Audit Plan

CommentAuditorProcessSite NameDate - Time

Activity

11-02-2019 - 09:30

Opening meeting

HO THN-IN,

TVV-IN,

PRK-IN

11-02-2019 - 10:00

Plant tour

HO THN-IN,

TVV-IN,

PRK-IN

11-02-2019 - 10:30

Audit

HO Top Management THN-IN,

TVV-IN,

PRK-IN

11-02-2019 - 11:00

Audit

HO Management Process THN-IN

11-02-2019 - 11:00

Audit

HO Production TVV-IN

11-02-2019 - 11:00

Audit

HO Stores & Despatch PRK-IN

11-02-2019 - 12:00

Audit

HO Purchase PRK-IN

11-02-2019 - 13:30

Lunch

HO THN-IN,

TVV-IN,

PRK-IN

11-02-2019 - 14:00

Audit

HO Quality Assurance TVV-IN

11-02-2019 - 14:00

Audit

HO Training THN-IN



Page 6 / 61



CommentAuditorProcessSite NameDate - Time

Activity

11-02-2019 - 15:30

Audit

HO Maintenance THN-IN

11-02-2019 - 15:30

Audit

HO Marketing TVV-IN

11-02-2019 - 17:00

Auditor(s)

preparation for

closing meeting

HO THN-IN,

TVV-IN

11-02-2019 - 17:30

Closing meeting

HO THN-IN,

TVV-IN

13-02-2019 - 09:30

Reporting

HO THN-IN



Page 7 / 61



08-03-2019Audit plan preparation date

Comment

Audit Plan is tentative.

General & legal compliance requirements

Refer Appendix-1





3 AUDIT PROCESS

3.1 AUDITOR NOTES / SIGNIFICANT AUDIT TRAILS

Mr. ANATHA KUMAR11-02-2019

DateAuditor ContactsProcess

PRIYADARSANAN

KAPPALLIL

MADHAVAN

Purchase

Standard

ISO

9001:2015

Notes

The process involves selection of vendors/suppliers, purchase of raw material and components, issuing of raw

material kits to external provider, outsourcing of assembly processes and receipt of final assemblies from the external

provider by the organization. The suppliers are selected on the basis of their capability to supply quality

materials/components within specified requirements of quality and delivery date. Existing suppliers are taken as

approved suppliers based on their past performance. Based on evaluation of samples supplied, the supplier is

approved. Supplier rating is being carried out on the external provider on a monthly basis as evidenced digitally.

Vendor Qualification is done on new vendors as per Doc Ref No. F/PURIOS Rev No.00 dated 03.02.2014.

The overall procedure followed is the Standard Operating Procedure for Store Process vide Doc Ref No. SOP/STR/08

Rev 3 Issue 2 dated 01.02.2019 and the Work Instruction Ref No. WI/STR/01-S2 Rev No.1 Issue 1 dated 28/5/2018 .It

was evidenced that Raw Materials are issued to the External Provider M/s Varidha, Mysore, by Work Order as

evidenced in Work order Ref No. VET/0081/2018-19 dated 31 Jan 2019. This external provider was selected as the

provider of ‘Wave Soldering Process’ after a series of trials culminating in validation of the process and freezing of its

operating parameters.

The organization ensures that externally provided products procured from overseas suppliers conform to

requirements in an indirect way by testing the final assembly product only. There is no test required to be done on

components at inward goods section as evidenced in Inspection Plan Ref No. WI/QA/02-S2 Rev 00 Issue No.1 dated

20/7/2015. However, controls are being applied on such externally provided products by ensuring that the components

are procured only from authorized dealers/manufacturers of the designated component manufacturer recommended by

the client. For example, for the item HBC Fuse TIA20, the client M/s Siemens Healthcare has recommended that the

procurement should be Fuses of GE ( Cooper Bussmann) make only. It was evidenced the items are actually being

procured from dealer M/s Kreatronix as per Invoice G181961241 dated 25 Jan 2019 for supply of Qty 760 numbers.

As per Sales order No. 212755910 dated 11.1.2018, M/s EATON who is the manufacturer of the GE/Cooper

Bussmann product has originally supplied Qty 360 numbers of the item to M/s Kreatronix.

The organization communicates to external providers, its requirements for processes and products by verbal

communication only and not by documented manner. However, it was verbally confirmed that the organization has so

far not determined/communicated to its external providers any requirements for competence, including any

qualification of persons carrying out outsourced processes, although there is no objective evidence, since all

communication is verbal. (Clause 7.2 under Training/HR refers).

QUALITY OBJECTIVES: There are two stated KPIs: i) Cost Reduction in K to be >150K/Qtr and ii)

Supplier rating should be minimum 80%. As per the KPI monitoring Sheet 2018-19 updated digitally every quarterly

basis, both KPIs are met.

INTERNAL AUDIT: The last IA was conducted on 12 Jan 2019 and one NC was recorded. Correction and Corrective

action has been taken.

Purchase Process is satisfactory.





Mr. HANUMANTHARAYAPPA11-02-2019


PRIYADARSANAN

KAPPALLIL

MADHAVAN

Stores & Despatch

Standard

ISO

9001:2015

Notes

Description of process: GRN is received and the quantity of inward goods received is verified. A copy of GRN is sent

to Inwards Goods Inspection (QA) where quality assurance tests are conducted. Quarantine stores is used to keep

goods till QA tests are over. On completion of QA tests, goods are stored in Store-1 and Store-2.The location of

storage is determined as per Index Store-1 Rack dated 21.7.2018 and Store-1 Location Map dated 21.7.2018.The

storage is done as per evidenced in the Standard Operating Procedure for Stores Process Doc Ref No. SOP/STR/08

Rev 3 & Issue No.2 dated 01.02.2019. Inward goods are segregated into racks having three boxes A,B and C in each

rack. Finished goods are stored in FG Stores and are identified by their work order numbers displayed on their

packings with ink.

Bin cards are used to keep tally of the quantity of each item being issued as evidenced in Bin Card No.F/STR/03/S1

for Rack 1-A, Box-2. One Dispatch Register is maintained for recording the quantity of stores issued against each

work order as evidenced in Despatch Register No.63. Checked Work Order Traceability as per Register Reference

No.R/STR/103/S1 dated 16.8.2018 for Work Order No.WO-151 and Indent No.654. Traceability is maintained as

evidenced by recording of Quantity 45,000 SETS of the items PCB , LED ,Single pole Slide switches etc.,sent to

Assembly L-1,L-2,L-4 and L-6.

QUALITY OBJECTIVE: The KPI set for 2018-19 is that Stock not to exceed 0.5%.Stock assessment is done on first

day of every month and its trend is displayed digitally on a graph as evidenced in the graph for the current year

2018-19.The Quality Objective of Stock percentage to be within 0.5% is being met as evidenced from the recorded

values of Stock % for the months of the current year2018-19, which are as follows:-

April-0.41%; May-0.07%; June-0.14%; July-0.27%; Aug-0.21%; Sep-0.4%; Oct-0.30%; Nov-0.15%; Dec-0.03% and

Jan-0.4%.

INTERNAL AUDITS: Internal Audits are being conducted as per IA Schedule No. F/IQA/03 dated 26.10.2016 Rev 0

Issue 02 on four monthly basis. Last audit conducted on 11the and 12th of January 2019 with two reported NC.

Corrective action taken and NC closed. Audit Plan followed is as evidenced Ref Doc No. F/1QA/01 dated 26.10.2016.

Packing and Final Inspection are observed to be done as per Work Instruction Ref No. WI/QA/02-S2 Rev 00 Issue

No.1 dated 20/7/2015. Final Inspection is done as per the Inspection Plan and release of product is done after planned

arrangements are completed with evidence of conformity to acceptance criteria. Traceability to the person authorizing

the release is complied with as evidenced in the digitally signed Tax Invoice/ Bill of Sale No.0501/2018-2019 dated 31

Jan 2019 for supply of 10 Nos FG Filament Inverter PCB D781, 4 Nos FG Display and Key PCB D730 and, 7 Nos

FG Fluoroscopy Display PCB D806. The stores and dispatch process was found satisfactory.





MR. PERUMAL.RAJ.J.S11-02-2019


T. V. VARDARAJAN Marketing

Standard

ISO

9001:2015

Notes

Marketing receives customer enquiries review and determine the product requirement, procure order , handle

customer complaints and measure customer satisfaction

Audit sample

• Customer order no TTSSL/PO/2018-19/022 dtd 2-2-19 of m/s Trinity Technologies, Hubli for 3000 nos of LED

• Customer order no 4500191072 dtd 4-2-19 of m/s Godrej , Pondicherry for 400000nos of PCBs

Inquiry by email dtd 17-01-19

Quotation by e mail dtd 17-01-19

Feasibility review record vide form F/MK/01 dtd 17-1-19

Customer complaint register F/MKT/03 listed 9 complaints in the year 2018-19. Corrective action report dtd 7-1-19 for

a sample complaint from M/s Scientific Mes-Technik ltd, Indore regarding display failure in 100 nos and complaint

dtd 4-7-18 from m/s Incap regarding No glow in 10nos of LED , checked . Customer communication includes the

complaint resolution also

Customer satisfaction procedure SOP/MKT/05 dtd 25-1-18

Customer feed backs analysed and over all satisfaction level is determined. For 2016-17 it is 84 % and the same for

2017-18, it is 84.84%.

Overall process is satisfactory





Mrs. MARY.A11-02-2019


T. V. VARDARAJAN Quality Assurance

Standard

ISO

9001:2015

Notes

The function is responsible for incoming, in-process and final product inspection. Calibration of test equipment

There is no Quality plan made

Sampling plan vide SOEPL/F/QA/09 dtd16-10-17

SOP QA 11 dtd 25-1-18

Audit sample

Incoming inspection of flux MCE#007 LRF dtd 1-2-19 , Qty 200 Litres and PVC vide inspection report dtd 2-2-19.

Twisted wires, green and yellow 50000 nos each dtd 24-01-19 vide inspection report dtd

However, there is no evidence of complying with the sampling plan that requires 32 litres to be sampled for lot of

200litres. Clause 8.1

In-process inspection report FT 128 dtd 9-2-19 of PCB assembly , There are 11 defects recorded I.e, 6 for soldering

short, 4 for pin hole , 1 for LED lift.

Final test report FT129 dtd 6-12-18 of PCB Qty 10 nos and the rejection log for the month Jan 2019. 70, 009 nos

foundn on conforming out of 1740290 nos inspected for 11 types of defects like LED Lift, diode reverse, without

switch/ fuse etc.

However corrective action not evident

Master list of calibration vide F/CAL/01 dtd 5-2-19 checked. There are 32 equipment listed with defined frequency and

source. Sampled the report of Digital multimeter SL NO 50459 vide report dtd 14-1-19 at Transcal.

The Quality objectives include FPY, Customer complaints etc. however no corrective action evident for the

complaints in April 18 is 3 against target of <1.

Overall process is satisfactory except the NC





Mr. PANDYAN11-02-2019


T. V. VARDARAJAN Production

Standard

ISO

9001:2015

Notes

The process includes receipt of inputs like active components like Diodes, resisters, LED , switched , fuse etc and

stuff the, soldering the wires, inspection/ testing and packing .

Objectives and targets checked and noted there are 3objectives set

To achieve production of PCB/LED/DISPLAYS in lakh nos per month : 12,5 and 15 Actual in July 18 is 9.3 L

FPY of 97.5 % . Actual is okay

OEE of 80%. Actual in Nov 18 is 56 %

Action plan to achieve the targets not evident

Corrective actions for variance in achieving the target is not evident.

Risk and opportunity F/RSK/01 dtd 27-9-18 listing 4 risks and opportunities checked. However a mitigation plan for

the risks not evident

Production plan is based on the customer order and the sample for jan 19 checked. PCB is 16lakhs. However, similar

plan is not evident for other products. Actual production of PCB is 1590000 nos

Production planning can cover all products

Corrective actions for Variance between target and actual required

Audit Samples

• Work order no 139 dtd 16-1-19 for PCB Active +

• Work order no 13 dtd 29-12-18for LED

• Work order no 06 dtd 11-12-18 for Displays

Production controls checked vide the

Product description by a photograph

Work instruction WI/MFG/052 dtd 20-7-15

Work instruction WI/MFG/044 dtd 18-9-18 of stuffing thru-hole

Process log dtd 9-2-19

Final inspection report FT-129 dtd 18-1-19 of PCB

Disposition by QA

There are 3 operators engaged in lead soldering. Ms.Haseena 1032 Ms. Muskaan 2274and Ms. Saranya2295.

Competency related to soldering qualification is not evident clause 8.5.1

Validation of wave soldering process is checked vide report dtd 2-3-18 valid for 1 year. Method of validation and

criterion for validation is established.

Identification is by way of tagging the work order number on Packing slip

There are 19 KPI defined and monitored on monthly basis . few of the indicators include customer satisfaction, OTD,

Reworks etc

The bonding process of LED is outsourced to M/s. However control of out sourced process is not evident clause

8.4.2

Overall process is satisfactory except the NC





Mr. Pandiyan11-02-2019


NAGARAJU

THEJASWINI

Maintenance

Standard

ISO

9001:2015

Notes

Risk and opportunities are determined

- Delay in assembly of the product due to machine breakdown

Objectives

Standard operating procedure for Maintenance process, SOP/MNT/10 Rev No 01 dtd 01.07.2017 Issue No 02 dtd

01.07.2017

Evidenced equipment List, F/MNT/01 Rev No 00 dtd 26.10.2016 that consist of Wave Soldering machine, Die bonding

display, Soldering station, manual wire bonder lamps, Power driven resistor cutting machine

Verified the break down activities for the below sample

(a) Equipment – Wave soldering machine

Breakdown dated – 22.01.2019

Break down hours – 1 hour

Break down for belt problem

Root cause – Bearing problem

Corrective action – Bearing maintenance included in preventive action plan

(b) Equipment - Power driven resistor cutting machine

Break down dtd – 15.09.2018

Break down hours – 2 hours

Break down for Cutting problem

Route cause – Teeth of cutting wheel broken

Action- New center wheel assembly replaced

Preventive maintenance for

(a) wave soldering done in the Month of Jan 2019, Dec 2018, Nov 2018

(b) Power driven resistor cutting machine for the month of Oct 2018, Nov 2018, Dec 2018

No NCs from last internal audit






Mr. Prummal Raj, Mr. Anatha

Kumar

11-02-2019


NAGARAJU

THEJASWINI

Management Process

Standard

ISO

9001:2015

Notes

Quality Manual Ref No QM/01 dtd 26.10.2016

Context of the organization, Doc Ref QM/I Rev No 01 dtd 23.11.2018

External issue – Competitors offers products with low cost, Increase in raw material, Meeting customer demands on

time

Internal Issues are such that – Limited product range, Increase in product cost, Man power attitude

Interested parties are determined and needs and expectations of interested parties are listed-

(a) Customer – On-time delivery, Customized products as per requirement. Good packing condition

(b) Supplier – Clear purchase specification, Clear delivery schedules

Shareholder, Service providers, bankers, Employees……

External issues, Internal Issues, Issues arising out from fulfilling needs and expectations of interested parties are

considered in determining the risks and opportunities

Evidenced mitigation action for the identified risks and opportunities

Last review dtd 23.11.2018

Sequence and Interaction of the processes, QM/H Rev No 00 dtd 26.10.2016, Issue No 02 dtd 26.10.2016

Quality Policy dtd 26.10.2016

Quality Objectives

There are company objectives set in line with the company quality policy, and these company objectives are

percolated down to the various departments, these objectives are monitored, measured and periodically reviewed

Organization chart and Roles, responsibility and Authority, QM/G Rev No 01 dtd 20.01.2018, Issue No 02 dtd

26.10.2016

Internal Audit

Procedure – SOP/IQA/12 Rev No 00 dtd 26.10.2016, Issue No 02 dtd 26.10.2016

Frequency of internal audit – Once in 3 months

Last internal audit was conducted on 11.01.2019 – 12.01.2019, 3 NCs – 2 stores, 1 Purchase. The non-conformance

raised in last internal audit were closed with appropriate correction and corrective action

NCS are closed with appropriate correction and corrective action

Previous to that internal audit was conducted on 11.10.2018- 12.10.2018.1 NC from Production

Before that the internal audit was conducted on 17.08.2018 – 18.08.2018, 1 NC from Quality

Management review

Procedure – SOP/MRM/13 Rev No 00 dtd 26.10.2016 Issue No 02 dtd 26.10.2016

Frequency – Once in 6 months

Last management review was conducted on 07.02.2019

Previous to that management review was conducted on 15.10.2018

Before that 27.08.2018

All review inputs are covered as per the standard requirement






Mr. Vijayendra P Bhat, Mr.

Prakash Savanur

11-02-2019


NAGARAJU

THEJASWINI

Top Management

Standard

ISO

9001:2015

Notes

1) Interaction done with the top management on integration of the QMS into the business processes, intended

outcomes expected from the QMS and the system of monitoring, measurement and review, deployment of the quality

policy and quality objectives, allocation of resources, assignment of responsibilities and authorities for the QMS,

communication mechanisms, issues impacting the QMS, needs and expectations of interested parties, determination

of the risks and opportunities and the actions being taken to address them.

2) Top Management demonstrated leadership and committment towards the QMS which was clearly demonstrated by

their involvement and during the interaction.





Mr. Ananth Kumar11-02-2019


NAGARAJU

THEJASWINI

Training

Standard

ISO

9001:2015

Notes

Risks and opportunities are determined, Such as- No compete tent employee, No trainings to the employee, internal

conflict

Evidenced mitigation actions for the identified risks and opportunities

There are no recruitment happened in last year, Last recruitment happened in 01.12.2017, And in case of recruitment

it is directly handled by the top Management

Objectives are defined for the department, Compliance to statutory and regulatory requirement, Actual – Achieved

Conduct the training as per the training plan, Actual – 100%

Standard Procedural Manual for Training Process, SOP/TRG/04 Rev No 01 dtd 20.01.2018, Issue No 02 dtd

26.10.2016

Type of training – Induction trainings, On-Job training, Awareness training

Evidenced training plan for the period 2018-2019, F/TRG/04 Rev No 02 dtd 30.05.2018

Verified the below samples for training activities

(a) Awareness training - ISO 9001 awareness training dtd 03.01.2018

Trainer – External

Number of participants – 10

Training effectiveness evaluation was done, Verified for Mr. Hanumanth, and evaluated as satisfactory for both

understanding and Implementation

(b)On Job training – Wave soldering dtd 12.09.2018

Number of trainee – 5

Trainer – Internal

Training effectiveness evaluation was done on 04.11.2018, evaluated as qualified for in-depend handling of assigned

tasks for Ms. Haseena and Ms. Laths

( c) On Job training – PCB Simulation and wire removing dtd (Training duration from Oct 2017 – Mar 2018

Number of trainee – 10

Trainer – Internal

Training effectiveness evaluation was done on 05.10.2017, and evaluated as qualified for in-depend handling of

assigned tasks for Ms. Sangeetha M and Ms. Pramila N

There were no NCs from last internal audit






3.2 DOCUMENT REVIEW

Compliant CommentsDocument Review Item

X9K-A documentation

indicating the scope of your

Quality Management System

(QMS)

X9K-If available, a

documentation setting out

the issues, the relevant

stakeholders and their

relevant requirements for the

QMS

X9K-A detailed description of

the processes determined for

the QMS

X9K-The quality policy, quality

objectives and informations

on the associated planning

X9K-The minutes of your last

management review

X9K-The list of codes,

standards and legal /

regulatory requirements

applicable to products or

services provided

X9K-Internal audit plans

(realised and scheduled)

Document Review and Initial Audit Comments

The overall documentation is found to be satisfactory and is in line with ISO 9001 : 2015 standard requirement

Organisation Manual - Revision Date or number QM/01 dtd

26.10.2016

Doc. Review Completed on 11-02-2019





3.3 AUDIT SUMMARY REPORT PER STANDARD ISO

9001:2015

Department / Activity / Process

P

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M

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anagem

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M

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9K-4.1 Understanding the organization and its context ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-4.2 Understanding the needs and expectations of intereste... ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-4.3 Determining the scope of the QMS ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-4.4 Quality management system and its processes ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-5.1 Leadership and commitment ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-5.1.1 General ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-5.1.2 Customer focus ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-5.2 Quality policy ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-5.2.1 Establishing the quality policy ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-5.2.2 Communicating the quality policy ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-5.3 Organizational roles, responsibility and authorities ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-6.1 Actions to address risks and opportunities ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-6.2 Quality objectives and planning to achieve them ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-6.3 Planning of changes ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.1 Resources ✓ ✓ ✓ ✓

9K-7.1.1 General ✓

9K-7.1.3 Infrastructure ✓

9K-7.1.2 People ✓

9K-7.1.4 Environment for the operation of processes ✓

9K-7.1.5 Monitoring and measuring resources ✓

9K-7.1.6 Organizational knowledge ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.2 Competence ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.3 Awareness ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.4 Communication ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.5 Documented information ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.5.1 General ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.5.2 Creating and updating ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.5.3 Control of documented information ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.5.3.1 ( ) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-7.5.3.2 ( ) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-8.1 Operational planning and control ✓ 1 1

9K-8.2 Requirements for products and services ✓ ✓ ✓

9K-8.2.1 Customer communication ✓ ✓ ✓

9K-8.2.2 Determining the requirements related to products an... ✓ ✓ ✓

9K-8.2.3 Review of requirements related to products and serv... ✓ ✓ ✓

9K-8.2.3.1 ( ) ✓ ✓ ✓

Clauses





Department / Activity / Process

P

roductio

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Q

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M

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P

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S

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Despatc

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M

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9K-8.2.3.2 ( ) ✓ ✓ ✓

9K-8.2.4 Changes to requirements related to products and ser... ✓ ✓ ✓

9K-8.3 Design and development. of products and services

9K-8.3.1 General

9K-8.3.2 Design and development planning

9K-8.3.3 Design and development inputs

9K-8.3.4 Design and development controls

9K-8.3.5 Design and development outputs

9K-8.3.6 Design and development changes

9K-8.4 Control of extern. provided products and services ✓

9K-8.4.1 General ✓

9K-8.4.2 Type and extent of control 1 ✓ 1

9K-8.4.3 Information for external providers ✓

9K-8.5 Production and service provision ✓ ✓

9K-8.5.1 Control of production and service provision 1 ✓ 1

9K-8.5.2 Identification and traceability ✓ ✓

9K-8.5.3 Property belonging to customers or external provide... ✓ ✓ ✓

9K-8.5.4 Preservation ✓ ✓ ✓ ✓

9K-8.5.5 Post-delivery activities ✓ ✓ ✓ ✓

9K-8.5.6 Control of changes ✓ ✓

9K-8.6 Release of products and services ✓ ✓ ✓

9K-8.7 Control of nonconforming outputs ✓ ✓ ✓

9K-9.1 Monitoring, measurement, analysis and evaluation ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.1.1 General ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.1.2 Customer satisfaction ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.1.3 Analysis and evaluation ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.2 Internal audit ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.2.2 Internal audit programme ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.3 Management Review ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.3.1 General ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.3.2 Management review inputs ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-9.3.3 Management review outputs ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-10.1 Improvement - General ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-10.2 Nonconformity and corrective action 1 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 1

9K-10.3 Continual improvement ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

9K-* Use of marks, and/or reference to the certification ✓

Total 3 1 4

Exclusions

- 9K-8.3 Design and development of products and Organization does not involve in product design and

justification





services. manufactures as per the customer specifications and

requirements. Hence this clause is not applicable





3.4 NON CONFORMITY REPORT

Non conformities detailed herein shall be addressed through the organization’s corrective action process, in accordance with

the relevant corrective action requirements of the audit standard.

Hereunder you will find Bureau Veritas Certification requirements for:

· expected timelines to address the nonconformity (a)

· response content (b)

Expected timelines to address the non conformity (a)

Corrections and Corrective actions (if possible) to address identified major nonconformities shall be carried out immediately.

Correction, Root Cause Analysis and Corrective action plan together with satisfactory evidences of implementation shall be

submitted within 90 days after the last day of the audit unless Bureau Veritas Certification and client agree on a longer

period of time.

Review of nonconformities is done through desktop review. However, depending of severity of the findings, our auditor may

perform a follow up visit to confirm the actions taken, evaluate their effectiveness, and determine whether certification can be

recommended or continued.

For a minor nonconformity, correction, root cause analysis and corrective action plan shall be approved by the team leader and

verification of implementation and effectiveness of corrective action(s) taken will be performed at the next visit.

It is recommended that the Client provide responses early to allow time for additional reviews if needed.

For recertification time limits to address nonconformities will be defined by the team leader in order to have them implemented

prior to expiration of certification.

Any responses to the nonconformities which were raised may be either in hard copy or electronically using the NCR herein

(preferred) and forwarded to the Bureau Veritas Certification office.

Expected response content (b)

Client response to NCR should be reviewed by the lead auditor in three parts; correction, root cause analysis and corrective

actions.

In reviewing the three parts, the auditor looks for a plan and then evidence that plan is being implemented.

Correction

1. The extent of the nonconformity has been determined (NCR has been corrected & the client has examined the system to see

if there are other examples that need to be corrected). Ensure that correction answers the question “Is this isolated case or

not?” in other words “Is there a risk that this can reoccur at the other site / department?”

2. If correction cannot be immediate; a plan to correct the NCR may be appropriate (responsible & date).

3. Evidence that the correction was implemented or evidence that the plan is being implemented.

Root Cause Analysis

1. The Root Cause is not simply repeating the finding, neither is the direct cause of the issue.

2. Well thought out analysis to determine the true root cause: e.g. someone did not follow a process would be direct cause;

determining why someone did not follow a process would lead to the true root cause.

3. The root cause statement must focus on a single issue without any obvious """"""""""""""""why"""""""""""""""" questions

remaining.

If a """"""""""""""""why"""""""""""""""" question can reasonably be asked about the root cause analysis, this indicates that the

analysis did not go far enough.

4. Ensure that the root cause answers the question, “What in the system failed such that the problem occurred?”

5. Blaming the employee will not be accepted as the only root cause

6. Address problems with the process as well as what detection system failed

Corrective Action

1. The corrective action or corrective action plan addresses the root cause(s) determined in the root cause analysis. If you have

not defined true root cause you cannot prevent the problem from its reoccurrence

2. In order to accept the plan it shall include;

- actions to address the root cause(s)

- identification of responsible parties for the actions and

- a schedule (dates) for implementation.

- always include a “change” to your system. Training and/or publishing a newsletter are generally not changes to your

system

3. In order to accept the evidence of implementation:

a. Enough evidence is provided to show the plan is being implemented as outlined in the response (and on schedule).




(Certification Business)b. Note: Evidence in full is not required to close the NCR; some evidence may be reviewed during future audit when

verifying the corrective actions.

Auditing is based on a sampling process of the available information and the audit methods used were interviews, observations,

sampling of activities and review of documentation and records.





To be completed by Bureau Veritas

Date

11-02-2019

Organization Contract nº

4372044

Report n°

9KSMTVV-IN01SOUTHERN OPTOELECTRONICS DEVICES P.LTD

Non Conformity Observed During Main Audit

Process Production

Standard ISO 9001:2015

Clause 9K-8.5.1 Control of production and service provision

Site Name HO

Non Conformity Description

STANDARD REQUIREMENT:

The organization shall implement production and service provision under controlled conditions.

Controlled conditions shall include, as applicable:

a) the availability of documented information that defines:

1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed;

2) the results to be achieved;

b) the availability and use of suitable monitoring and measuring resources;

c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of

processes or outputs, and acceptance criteria for products and services, have been met;

d) the use of suitable infrastructure and environment for the operation of processes;

e) the appointment of competent persons, including any required qualification;

f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes or production and

service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;

g) the implementation of actions to prevent human error;

h) the implementation of release, delivery and post-delivery activities.

NON-CONFORMANCE STATEMENT:

Competency and qualification of Soldering operators not evident

EVIDENCES:

Wave soldering operators, Ms.Haseena #1032 Ms. Muskaan #2274and Ms. Saranya#2295

Grade Lead Auditor Auditor Organization Rep.

Major NAGARAJU THEJASWINI T. V. VARDARAJAN

To be completed before

22-02-2019 THN-IN 1-1KP20Q6 TVV-IN 1-14B1F-90

To be completed by the organization

Mr. PANDYAN

_

.

Root Cause Analysis (What failed in the system to allow this non conformity to occur ?)

Correction (What is done to solve this problem)

_





.

_

.

Corrective Action (What is done to prevent reoccurrence)

Implementation of

Corrective Actions

Date of Completion

Org. Representative

_

_


Verification of

corrective Actions

Date Status

CA Waiting Proposal T. V. VARDARAJAN

Auditor

Comment






Date

11-02-2019


4372044

Report n°



Process Production


Clause 9K-8.4.2 Type and extent of control

Site Name HO



The organization shall ensure that externally provided processes, products and services do not adversely affect the

organization’s ability to consistently deliver conforming products and services to its customers.

The organization shall:

a) ensure that externally provided processes remain within the control of its quality management system;

b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting

output;

c) take into consideration:

1) the potential impact of the externally provided processes, products and services on the organization’s ability to

consistently meet customer and applicable statutory and regulatory requirements;

2) the effectiveness of the controls applied by the external provider;

d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and

services meet requirements.


Control of out sourced processes is not evident

EVIDENCES:

The bonding process of LED is outsourced to M/s. Wuxi Ever bright co ltd, China


Minor NAGARAJU THEJASWINI T. V. VARDARAJAN




Mr. PANDYAN

_

.



_

.





_

.


Implementation of

Corrective Actions

Date of Completion

Org. Representative

_

_


Verification of

corrective Actions

Date Status


Auditor

Comment






Date

11-02-2019


4372044

Report n°



Process Quality Assurance


Clause 9K-8.1 Operational planning and control

Site Name HO



The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the

provision of products and services, and to implement the actions determined in Clause 6, by:

(e) determining, maintaining and retaining documented information to the extent necessary:

1) to have confidence that the processes have been carried out as planned;

2) to demonstrate the conformity of products and services to their requirements.


There is no evidence of complying with the specified sampling plan SP001.

EVIDENCES:

Incoming inspection of flux MCE#007 LRF dtd 1-2-19 of 200 liters . Sample Qty is not known while the sampling plan

specified 32 litres.


Minor NAGARAJU THEJASWINI T. V. VARDARAJAN




Mrs. Mary A

_

.



_

.

_

.






Implementation of

Corrective Actions

Date of Completion

Org. Representative

_

_


Verification of

corrective Actions

Date Status


Auditor

Comment






Date

11-02-2019


4372044

Report n°



Process Production


Clause 9K-10.2 Nonconformity and corrective action

Site Name HO



When a nonconformity occurs, including any arising from complaints, the organization shall:

a) react to the nonconformity and, as applicable:

1) take action to control and correct it;

2) deal with the consequences;

b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur

elsewhere, by:

1) reviewing and analysing the nonconformity;

2) determining the causes of the nonconformity;

3) determining if similar nonconformities exist, or could potentially occur;

c) implement any action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportunities determined during planning, if necessary;

f) make changes to the quality management system, if necessary.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.


Corrective actions for several of the non-conformities are not evident

EVIDENCES:

a) In-process inspection report FT 128 dtd 9-2-19 of PCB assembly , There are 11 defects recorded I.e, 6 for soldering

short, 4 for pin hole , 1 for LED lift.

b) Final test report FT129 dtd 6-12-18 of PCB and the Rejection log for the month Jan 2019. 70, 009 nos foundn on

conforming out of 1740290 nos inspected for 11 types of defects like LED Lift, diode reverse, without switch/ fuse etc.

c) Customer complaints from M/s Scientific Mes-Technik ltd, Indore regarding display failure in 100 nos and complaint

dtd 4-7-18 from m/s Incap regarding No glow in 10nos of LED ,

d) Actuals is not complying with the set Targets in production objectives

In July 18, PCB produced is 9.3 against 12 lakh nos

In Nov 18, OEE is 56% against 80%


Major NAGARAJU THEJASWINI T. V. VARDARAJAN




Mr. PANDYAN, Mrs.

MARY A, MR.

PERUMAL.RAJ.J.S





_

.



_

.

_

.


Implementation of

Corrective Actions

Date of Completion

Org. Representative

_

_


Verification of

corrective Actions

Date Status


Auditor

Comment





4 PERFORMANCE TO DATE

The Quality Management System is found to be effective with the existence of documented information at appropriate levels like Quality Manual, Quality Policy, Quality Objectives,

Procedures and Work Instructions. Quality Plan, Documents, Records, Formats, etc., are also available.

Internal Audits and Management Reviews are being conducted as per the plan. The Customer satisfaction is collected periodically. Awareness on quality management system among

the personnel was also found to be good.

All the requirements of ISO 9001:2015 are addressed in the quality manual. Overall, the quality management system documentation is found adequate.

The organisation has established Quality policy and Quality objectives in line with the Quality Policy. Specific functional measurable quality objectives have also been established for

supporting the organisational quality objectives. Trend towards achievement of Quality Objectives are being reviewed in Management Review Meetings.

Non conformity

number

Non conformity description Process Standard Clause Grade Issued Date Date of Completion Verification

of Corrective

action

9KSMTVV-IN01 __11-02-2019Major9K-8.5.1 Control

of production and

service provision

ISO

9001:2015

ProductionSTANDARD REQUIREMENT:

The organization shall implement production

and service provision under controlled

conditions.

Controlled conditions shall include, as

applicable:

a) the availability of documented information

that defines:

1) the characteristics of the products to be

produced, the services to be provided, or the

activities to be performed;

2) the results to be achieved;

b) the availability and use of suitable

monitoring and measuring resources;

c) the implementation of monitoring and

measurement activities at appropriate stages

to verify that criteria for control of processes

or outputs, and acceptance criteria for

products and services, have been met;

d) the use of suitable infrastructure and



Page 32 / 61



Non conformity

number


of Corrective

action

environment for the operation of processes;

e) the appointment of competent persons,

including any required qualification;

f) the validation, and periodic revalidation, of

the ability to achieve planned results of the

processes or production and service

provision, where the resulting output cannot

be verified by subsequent monitoring or

measurement;

g) the implementation of actions to prevent

human error;

h) the implementation of release, delivery and

post-delivery activities.


Competency and qualification of Soldering

operators not evident

EVIDENCES:

Wave soldering operators, Ms.Haseena #1032

Ms. Muskaan #2274and Ms. Saranya#2295

9KSMTVV-IN02 __11-02-2019Minor9K-8.4.2 Type and

extent of control

ISO

9001:2015


The organization shall ensure that externally

provided processes, products and services do

not adversely affect the organization’s ability

to consistently deliver conforming products

and services to its customers.

The organization shall:

a) ensure that externally provided processes

remain within the control of its quality



Page 33 / 61



Non conformity

number


of Corrective

action

management system;

b) define both the controls that it intends to

apply to an external provider and those it

intends to apply to the resulting output;

c) take into consideration:

1) the potential impact of the externally

provided processes, products and services on

the organization’s ability to consistently meet

customer and applicable statutory and

regulatory requirements;

2) the effectiveness of the controls applied by

the external provider;

d) determine the verification, or other

activities, necessary to ensure that the

externally provided processes, products and

services meet requirements.


Control of out sourced processes is not

evident

EVIDENCES:

The bonding process of LED is outsourced to

M/s. Wuxi Ever bright co ltd, China

9KSMTVV-IN03 __11-02-2019Minor9K-8.1

Operational

planning and

control

ISO

9001:2015

Quality

Assurance


The organization shall plan, implement and

control the processes (see 4.4) needed to

meet the requirements for the provision of

products and services, and to implement the

actions determined in Clause 6, by:



Page 34 / 61



Non conformity

number


of Corrective

action

(e) determining, maintaining and retaining

documented information to the extent

necessary:

1) to have confidence that the processes

have been carried out as planned;

2) to demonstrate the conformity of products

and services to their requirements.


There is no evidence of complying with the

specified sampling plan SP001.

EVIDENCES:

Incoming inspection of flux MCE#007 LRF

dtd 1-2-19 of 200 liters . Sample Qty is not

known while the sampling plan specified 32

litres.

9KSMTVV-IN04 __11-02-2019Major9K-10.2

Nonconformity

and corrective

action

ISO

9001:2015


When a nonconformity occurs, including any

arising from complaints, the organization

shall:

a) react to the nonconformity and, as

applicable:

1) take action to control and correct it;

2) deal with the consequences;

b) evaluate the need for action to eliminate

the cause(s) of the nonconformity, in order

that it does not recur or occur elsewhere, by:

1) reviewing and analysing the nonconformity;

2) determining the causes of the



Page 35 / 61



Non conformity

number


of Corrective

action

nonconformity;

3) determining if similar nonconformities exist,

or could potentially occur;

c) implement any action needed;

d) review the effectiveness of any corrective

action taken;

e) update risks and opportunities determined

during planning, if necessary;

f) make changes to the quality management

system, if necessary.

Corrective actions shall be appropriate to the

effects of the nonconformities encountered.


Corrective actions for several of the

non-conformities are not evident

EVIDENCES:

a) In-process inspection report FT 128 dtd

9-2-19 of PCB assembly , There are 11

defects recorded I.e, 6 for soldering short, 4

for pin hole , 1 for LED lift.

b) Final test report FT129 dtd 6-12-18 of

PCB and the Rejection log for the month Jan

2019. 70, 009 nos foundn on conforming out

of 1740290 nos inspected for 11 types of

defects like LED Lift, diode reverse, without

switch/ fuse etc.

c) Customer complaints from M/s Scientific

Mes-Technik ltd, Indore regarding display

failure in 100 nos and complaint dtd 4-7-18



Page 36 / 61



Non conformity

number


of Corrective

action

from m/s Incap regarding No glow in 10nos of

LED ,

d) Actuals is not complying with the set

Targets in production objectives

In July 18, PCB produced is 9.3 against 12

lakh nos

In Nov 18, OEE is 56% against 80%



Page 37 / 61



5 EXECUTIVE AUDIT SUMMARY

Auditing is based on a sampling process of the available information and the audit methods used were interviews,

observations, sampling of activities and review of documentation and records.

A three manday Recertification audit was conducted by Ms. Thejasiwni Nagaraju as Team Leader & Mr.T V

Vardharajan and Mr. Priyadharshan as team Memeber at Venkateshpuram site. Out of three man-days, 2.5 was onsite

audit and 0.5 man-day was for offsite reporting on 13.02.2019.The audit was conducted against the ISO 9001:2015

standard. The objective of the audit was to determine conformance to the QMS requirements.

Audit plan was communicated in advance. The audit was started with an opening meeting attended by the Top

Management & all auditees where the audit scope, criteria, methodology, sampling principle & confidentiality clause

were explained. The possible outcomes of the audit & the processes of raising nonconformity reports & gradation of

nonconformance were also explained. The audit plan was confirmed & communicated at the end of the opening

meeting.

During the audit two major and two minor nonconformity reports were raised. The positive observations as well as

opportunities for improvements were shared with the auditees in the closing meeting at respective sites attended by the

concerned auditees & the MR. The audit sampling principle & process for closure of non-conformities was also

explained. It was informed that all Bureau Veritas Certification auditors are bound by a confidentiality agreement with

Bureau Veritas Certification and that any information that we may come across during the audit process will be strictly

kept as confidential and not disclosed to any third party without prior consent from the organization. The organization

has agreed to vacate the NCRs raised within the next 10 days.

Based on the Number and Nature of non-conformance the organization is recommended for follow-up audit of one

manday

5.1 AUDIT CONCLUSIONS

5.2 SUMMARY OF AUDIT FINDINGS

Major Minor

N° of Non Conformities recorded 2 2





5.3 MANAGEMENT SYSTEM EFFECTIVENESS

Basic Inputs:

A three man-day Recertification audit was conducted by Ms. Thejasiwni Nagaraju as Team Leader & Mr.T V

Vardharajan and Mr. Priyadharshan as team Member at Venkateshpuram site. Out of three man-days, 2.5 was onsite

audit and 0.5 man-day was for offsite reporting on 13.02.2019.The audit was conducted against the ISO 9001:2015

standard. The objective of the audit was to determine conformance to the QMS requirements.

The audit plan was sent in advance and the audit was conducted as per the plan. A brief opening meeting was

conducted with Top Management and other Process owners. It was held to explain on the audit process, grading of

non-conformities, confidentiality, disclaimer and the possible outcome of the audit and brief introduction of Bureau

Veritas India Pvt. Ltd. and its new services and activities. The audit is conducted with respect to the ISO 9001: 2015

standard.

Confirm if the data provided in the application is valid:

The inputs like address, number of sites, manpower, accreditation, shifts were verified and found to be correct.

Description of the company activities:

M/s. SOUTHERN OPTOELECTRONIC DEVICES PVT LTD was the second company in India and first in Karnataka to

start manufacturing LED (Light Emitting Diode) Lamps and Seven Segment Displays with fully automated factory and

established in the year 1987 after extensive market research to meet the potentially high demand area, and has now

grown to become a leader in the manufacturing and marketing of Optoelectronic devices. The complete range of

lamps and displays are sold under the brand name "Starlite”. Starlite lamps and displays are manufactured against

specifications of the customer. The company is also the OE supplier, supplying against brand specifications and to

various key customers. The key customers includes M/s Godrej Consumer Products Ltd, M/s Siemens, M/s Secure

Meters Ltd, M/s MRO TEK Ltd, M/s BEL,M/s Altek Systems M/s Phoenix Contact India Pvt Ltd, etc. The factory

building is located at No.104, Venkateshpuram, Arabic College Post, Bangalore - 560 045. The organization has a

good infrastructure facility, like Die Bonding M/c, Gold Wire Bonding M/c, Curing Oven, Wave Soldering M/c, and

various types of monitoring and measuring equipment.

Validation of scope of certification:

The scope of certification remains same and is retained as-

“MANUFACTURE OF LED LAMPS, LED DISPLAYS, POPULATED PCB ASSEMBLIES AND LED LIGHTING

PRODUCTS”

The audit team has validated the scope of certification in the following manner:

The organisation has identified all the processes required and established the controls required. Procedures, SOPs,

and Formats are established. Competent manpower is provided. Required expertise to the manpower been provided.

Required infrastructure for production like Wave Soldering machine, Die bonding display, Soldering station, manual

wire bonder lamps, Power driven resistor cutting machine….required for production activities have been identified and

provided. Appropriate monitoring and measurement mechanism established. Conducive work environment been

provided. Required legal requirements been identified and compliance is evidenced. Executed many projects

successfully, Customer satisfaction is collected periodically. Evidenced many work orders in hand.

The Clause 8.3 - Design and Development of products and services from the requirements of ISO 9001:2015 Standard

is not applicable

Organization does not involve in product design and manufactures as per the customer specifications and

requirements. Hence this clause is not applicable

Manual Adequacy

Quality Manual – QM/01 dtd 26.10.2016, All the requirements of ISO 9001:2015 are addressed in the manual. The

process is well established. All the requirement of the standard is adequately addressed in the manual. The

mandatory documented procedures have reference in the Quality Manual. The Quality Manual includes Quality Policy

and Quality Objectives. The Quality Manual is established, maintained & controlled.





Achievement of Policy commitments:

The Top Management of the organization has established a Quality Policy which has been communicated throughout

the organization by displaying at prominent places. The present quality policy is well defined and is appropriate to the

purpose of the organization. Measurable quality objectives have been established which are monitored periodically

through MR meetings. The Quality Policy was displayed and communicated to all employees. The Top management

involvement and commitment is visible.

Description of System Conformance:

The organizations QMS documentation consists of a quality manual including mandatory procedures, work instruction,

check lists and formats. The documentation is process oriented and structured based on ISO 9001:2015

requirements. The quality objectives are set for the achievement of the company’s goals. The system is matured with

adequate process monitoring system and quality plans in place. The management is committed to continually improve

the effectiveness of the system. The effectiveness of quality management system is periodically measured &

monitored by internal audits and reviewed through Management review meetings. Experienced staff is available in the

organization and organizational knowledge is adequate for the employees/staffs. Appropriate trainings are planned to

maintain the knowledge necessary for the operation of its processes and to achieve conformity of products and

services and also to acquire new knowledge. Customer feedbacks are captured periodically, in line with the

requirements of ISO 9001:2015 Standard.

Internal Audit:

Frequency - Once in 3 months. Last conducted internal audit on 11.01.2019 – 12.01.2019, 3 non conformances

raised. The non-conformances raised in the internal audit are closed with appropriate root cause, correction and

corrective action

Management review:

Frequency – Once in 6 months. Last conducted – 07.02.2019, All the input points as per standard requirement are

reviewed in management review

Verification of each previous Bureau Veritas Certification audit nonconformities:

SA 2 – 3 NCs

1. Validation of wave soldering process is checked vide report dtd 2-3-18 valid for 1 year. Method of validation and

criterion for validation is established.

2. Last internal audit was conducted on 11.01.2019 – 12.01.2019, 3 NCs – 2 stores, 1 Purchase. The

non-conformance raised in last internal audit were closed with appropriate correction and corrective action

3. Not able to achieve the business goals, Mitigation action – KPI’s defined and tracked and reviewed periodically to

know the status

SA 1 – 4 NCs

1. Sampled the report of Digital multimeter SL NO 50459 vide report dtd 14-1-19 at Transcal. This instrument is with-in

valid calibrated period

2. Incoming inspection of flux MCE#007 LRF dtd 1-2-19 , Qty 200 Liters and PVC vide inspection report dtd 2-2-19.

Incoming inspection is done as per the requirement of the raw material

3. Actuals is not complying with the set Targets in production objectives – Since the closure is not effective raised as

major NC

4. Incoming inspection is carried out and reports evidenced for flux MCE#007 LRF dtd 1-2-19 , Qty 200 Liters

Re-Certification Audit– 2 NCs

1. Competency and qualification of Soldering operators not evident – Raised as Major NC

2. Root Cause, correction and Corrective action evidenced for Equipment – Wave soldering machine

Breakdown dated – 22.01.2019

– Effectiveness of corrective action taken is not fully Satisfactory

Extent to which the previous audit findings have been addressed by the system:

The corrective actions addressing the root cause are effective.

External communication:

The Client has adequate infrastructure for external communication with customers. The general modes of

communications are e-mail, and telephone.





Comments on effectiveness of system implementation during the second/third shifts:

Organization is being operated in general shift. Internal communication is good across the organization with regards to

process to be carried out. Effectiveness of Quality Management System found good.

Uncertainty / obstacles that could affect the reliability of audit conclusions:

Nil

Use of logo:

Verified visiting cards, Test certificates, product, Letterheads. BV Logo is used on Vising cards and Letterheads.

Miss use of BV Logo was not observed during this audit

Agreed follow-up actions:

During the audit two major and two minor nonconformity reports were raised. The organization has agreed to vacate

the NCRs raised within the next 10 days.

Based on the Number and Nature of non-conformance the organization is recommended for follow-up audit of one

man-day.





5.4 BEST PRACTICES

Good housekeeping

Infrastructure

5.5 UNRESOLVED POINTS ON DIVERGING OPINIONS

Unresolved points concerning diverging opinions about evidences and

findings

NIl





6 TEAM LEADER RECOMMENDATIONS

Standard Accreditation Certificate Copies Language

ISO 9001:2015 UKAS 1 EN


Recommendation Grant Certification after a satisfactory corrective action plan is completed.

Reason for issue or change of

the certificate

Re-certification audit

Scope Modification Comments As per CR the Scope is “Manufacture of LED Lamps, Numeric, Alpha Numeric

and Dot Matrix LED Displays, populated PCB Assemblies and Led lighting

Products”

The scope is revised to “MANUFACTURE OF LED LAMPS, LED DISPLAYS,

POPULATED PCB ASSEMBLIES AND LED LIGHTING PRODUCTS”

Is a follow up audit required Yes

Follow up audit start date 25-02-2019

Duration (days) 1





7 SURVEILLANCE PLAN

Site Name Process Clause

Surveillance

1 2 3 4 5 6 7 8 9






Surveillance

1 2 3 4 5 6 7 8 9

9K-4.1 Understanding

the organization and its

context


the needs and

expectations of

interested parties

9K-4.3 Determining the

scope of the QMS

9K-4.4 Quality

management system

and its processes

9K-5.1.1 General

9K-5.2 Quality policy

9K-5.2.2 Communicating

the quality policy

9K-6.2 Quality objectives

and planning to achieve

them

9K-6.3 Planning of

changes

9K-7.1.3 Infrastructure

9K-7.1.4 Environment

for the operation of

processes

9K-7.1.5 Monitoring and

measuring resources

9K-7.1.6 Organizational

knowledge

9K-7.5 Documented

information

9K-7.5.1 General

9K-7.5.2 Creating and

updating

9K-7.5.3 Control of

documented information

9K-7.5.3.1 ( )

9K-7.5.3.2 ( )

9K-8.1 Operational

planning and control

9K-8.5 Production and

service provision

9K-8.5.1 Control of

production and service

provision

9K-8.5.2 Identification

and traceability

9K-8.5.3 Property

belonging to customers

or external providers

9K-8.5.4 Preservation

X XHO Production






Surveillance

1 2 3 4 5 6 7 8 9

9K-8.5.5 Post-delivery

activities

9K-8.5.6 Control of

changes

9K-8.7 Control of

nonconforming outputs

9K-9.1 Monitoring,

measurement, analysis

and evaluation

9K-9.1.1 General

9K-9.1.3 Analysis and

evaluation

9K-9.2 Internal audit

9K-9.2.2 Internal audit

programme

9K-10.1 Improvement -

General

9K-10.2 Nonconformity

and corrective action

9K-10.3 Continual

improvement






Surveillance

1 2 3 4 5 6 7 8 9



context


the needs and

expectations of

interested parties


scope of the QMS

9K-4.4 Quality

management system

and its processes


9K-5.2.1 Establishing the

quality policy


the quality policy

9K-6.1 Actions to

address risks and

opportunities



them

9K-6.3 Planning of

changes

9K-7.4 Communication

9K-7.5 Documented

information

9K-7.5.1 General


updating

9K-7.5.3 Control of


9K-7.5.3.1 ( )

9K-7.5.3.2 ( )

9K-9.1 Monitoring,


and evaluation

9K-9.1.1 General


evaluation



programme

9K-9.3 Management

Review

9K-9.3.1 General

9K-9.3.2 Management

review inputs

9K-9.3.3 Management

review outputs

X XHO Management Process






Surveillance

1 2 3 4 5 6 7 8 9


General



9K-10.3 Continual

improvement

9K-* Use of marks,

and/or reference to the

certification






Surveillance

1 2 3 4 5 6 7 8 9



context


the needs and

expectations of

interested parties


scope of the QMS

9K-4.4 Quality

management system

and its processes

9K-5.1 Leadership and

commitment

9K-5.1.1 General

9K-5.1.2 Customer focus


9K-5.2.1 Establishing the

quality policy


the quality policy

9K-5.3 Organizational

roles, responsibility and

authorities

9K-6.1 Actions to

address risks and

opportunities



them

9K-6.3 Planning of

changes


knowledge

9K-9.1 Monitoring,


and evaluation

9K-9.1.1 General

9K-9.1.2 Customer

satisfaction


evaluation



programme

9K-9.3 Management

Review

9K-9.3.1 General

9K-9.3.2 Management

review inputs

9K-9.3.3 Management

X XHO Top Management






Surveillance

1 2 3 4 5 6 7 8 9

review outputs


General



9K-10.3 Continual

improvement

9K-* Use of marks,

and/or reference to the

certification

XHO Training






Surveillance

1 2 3 4 5 6 7 8 9



context


the needs and

expectations of

interested parties


scope of the QMS

9K-4.4 Quality

management system

and its processes

9K-5.1.1 General



the quality policy

9K-6.1 Actions to

address risks and

opportunities



them

9K-6.3 Planning of

changes


knowledge

9K-7.5 Documented

information

9K-7.5.1 General


updating

9K-7.5.3 Control of


9K-7.5.3.1 ( )

9K-7.5.3.2 ( )

9K-8.1 Operational


9K-8.2 Requirements for

products and services

9K-8.2.1 Customer

communication

9K-8.2.2 Determining the

requirements related to


9K-8.2.3 Review of



9K-8.2.3.1 ( )

9K-8.2.3.2 ( )

9K-8.2.4 Changes to


XHO Marketing






Surveillance

1 2 3 4 5 6 7 8 9


9K-9.1 Monitoring,


and evaluation

9K-9.1.1 General

9K-9.1.2 Customer

satisfaction


evaluation



programme


General



9K-10.3 Continual

improvement

XHO Purchase






Surveillance

1 2 3 4 5 6 7 8 9



context


the needs and

expectations of

interested parties


scope of the QMS

9K-4.4 Quality

management system

and its processes

9K-5.1 Leadership and

commitment

9K-5.1.1 General



the quality policy

9K-6.1 Actions to

address risks and

opportunities



them

9K-6.3 Planning of

changes

9K-7.1 Resources

9K-7.1.5 Monitoring and

measuring resources


knowledge

9K-7.5 Documented

information

9K-7.5.1 General


updating

9K-7.5.3 Control of


9K-7.5.3.1 ( )

9K-7.5.3.2 ( )

9K-8.1 Operational


9K-8.4.2 Type and

extent of control


and traceability

9K-8.5.3 Property




9K-8.5.6 Control of

X XHO Quality Assurance






Surveillance

1 2 3 4 5 6 7 8 9

changes

9K-8.6 Release of


9K-8.7 Control of


9K-9.1 Monitoring,


and evaluation

9K-9.1.1 General


evaluation



programme


General



9K-10.3 Continual

improvement






Surveillance

1 2 3 4 5 6 7 8 9



context


scope of the QMS

9K-4.4 Quality

management system

and its processes

9K-5.1.1 General



the quality policy



them

9K-6.3 Planning of

changes


knowledge

9K-7.5 Documented

information

9K-7.5.1 General


updating

9K-7.5.3 Control of


9K-7.5.3.1 ( )

9K-7.5.3.2 ( )


and traceability

9K-8.5.3 Property




9K-8.5.6 Control of

changes

9K-8.7 Control of


9K-9.1 Monitoring,


and evaluation

9K-9.1.1 General


evaluation



programme


General



XHO Stores & Despatch






Surveillance

1 2 3 4 5 6 7 8 9

9K-10.3 Continual

improvement






Surveillance

1 2 3 4 5 6 7 8 9



context


the needs and

expectations of

interested parties


scope of the QMS

9K-4.4 Quality

management system

and its processes



the quality policy

9K-6.1 Actions to

address risks and

opportunities



them

9K-6.3 Planning of

changes

9K-7.1 Resources

9K-7.1.3 Infrastructure

9K-7.1.4 Environment

for the operation of

processes

9K-7.5 Documented

information

9K-7.5.1 General


updating

9K-7.5.3 Control of


9K-7.5.3.1 ( )

9K-7.5.3.2 ( )

9K-9.1 Monitoring,


and evaluation


evaluation



programme


General



9K-10.3 Continual

improvement

XSITE 1 –

Bangalore

Maintenance





Man Days

DateSurv. plan prepared / modified by 13-02-2019NAGARAJU THEJASWINI

1.5 1.5

Comment Surveillance audit Plan is tentative





8 AUDIT PROGRAMME ISO 9001:2015

Audits

Main Surv1 Surv2

HO - Head Office 3 1.5 1.5

Man Days 3 1.5 1.5

Sites

Tentative number of days for recertification 3

Date 13-02-2019 Prepared / revised by NAGARAJU THEJASWINI

Comment Audit Programme is tentative.



Page 59 / 61



9 NEXT VISIT AUDIT PLAN

Site Name Process Auditor CommentDate - Time

Activity

13-02-2020 - 00:00

Audit

HO Production

13-02-2020 - 00:00

Audit

HO Quality Assurance

13-02-2020 - 00:00

Audit

HO Marketing

13-02-2020 - 00:00

Audit

HO Purchase

13-02-2020 - 00:00

Audit

HO Stores & Despatch

13-02-2020 - 00:00

Audit

HO Top Management

13-02-2020 - 00:00

Audit

HO Management Process

Audit plan preparation date 13-02-2019

Comment Next Audit plan is tentative.



Page 60 / 61



10 Certificate information

SOUTHERN OPTOELECTRONICS DEVICES P.LTD

Certificate information

Site Name

10.1 ISO 9001:2015 - UKAS - EN

Address No.104, Venkateshpuram , Arabic College Post

City BANGALORE

Postal Code 560045

-County/State

IndiaCountry

MANUFACTURE OF LED LAMPS, LED DISPLAYS, POPULATED PCB

ASSEMBLIES AND LED LIGHTING PRODUCTS

Scope

1Number of certificates



CERTIFICATION AUDIT REPORTsouthernopto.com/BVQI QMS Audit Report 2018-19.pdf · Recertification...

Documents

Transcript of CERTIFICATION AUDIT REPORTsouthernopto.com/BVQI QMS Audit Report 2018-19.pdf · Recertification...