530549302.

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Supplier Audit : Deepak Fasteners Ltd
Date : 04-06-2021 to 05-06-2021

Quality Management System Assessment Number of Observations

Category Audit Score Max Score Final Score NC OFI BP
Document Control - ISO 7.5.1, 7.5.2, 7.5.3 9 11 81.82
Leadership -ISO 5 26 30 86.67
Human Resources - ISO 7.1.2 7 10 70
Safety - ISO 7.1.4, TS16949 6.4.1 6 8 75
Customer Requirements - ISO multiple clauses 8 12 66.67
Supplier Management -ISO8.4 12 15 80
Planning - ISO 8.1 5 6 83.33
Engineering/Product Development - ISO 8.2 NA NA Marking done in check list considering Process Design
Product Realization - Shop Floor - IQC 17 22 77.27
Product Realization - Shop Floor - Production 34 35 97.14
Product Realization - Shop Floor - Test 20 20 100
Product Realization - Control of Non-conforming product - ISO 8.7 5 5 100
Measurement Calibration Systems - ISO 7.1.5 11 14 78.57
Maintenance - ISO 8.5.1 7 8 87.5
Quality Assurance- ISO multiple clauses 21 22 95.45
Quality Management System Summary 188 218 86.24 0 0 0

Heat Treatment audit report 0 #DIV/0! 0 0

Forging Audit Report 0 #DIV/0! 0 0

% of Total Audit
Audit Score Max Score Score Final Score
Total Quality Management System Score 188 218 75 64.67889908
Total Factory Acceptance Test Score 0 25 #DIV/0!
Grand Total 188 218 100 #DIV/0!

Terminology: Audit Score Range Key

NC: Non- Conformance 80 - 100 Pass & Prefered
OFI: Opportunity For Improvement 70 - 79 Pass
BP: Best Practice 60 - 69 Conditional Pass
< 60 Fail

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Max Audit
Catoegory Clause # Evaluation Questions Score Guideline Score
How do customer specifications, requirements, and
special requests get defined and reviewed ? Can you
show me an example of a customer's requirement or
special request. (prefer SunEdison request if possible)

If no objective evidence score = 0 and issue minor non-

Customer conformance. If only hardcopy objective evidence score = 1, if
Requirements and Customer specifications - ISO automated system linked into business systems score = 2 and
communication 4.2, 7.4, 8.2 1 2 log BP.

How do customer specifications, requirements, and

special requests get recorded/documented? Can you
show me an example of a customer's requirement or
special request. (prefer SunEdison request if possible) 1 1

If no objective evidence score = 0 and issue minor non-

How are customer changes entered/recorded into your conformance. If only hardcopy objective evidence score = 1, if
Customer change requests - ISO systems? Can you show me an example of a customer automated system linked into business systems score = 2 and
8.2 2 change request 2 log BP. 1

If no management of change transition, score 0 and issue OFI

to 7.5.3 and 8.3, if hardcopy system only (stickers, colored
tags, or other poke yoke'd system) score 1, if online system
How are customer changes managed in your manages conversion, then score =2 If online system for
3 production line? 3 traceability and poke yoke, score 3 and issue BP. 1

Check the QA/QC Plan against the drawing requirements

How are special customer requests checked prior to **The supplier/factory must have sample QAPs from their
4 shipment? 1 customers. 1
If a request cannot be met, how is this communicated
5 back to the requester/customer? 1 1

Customer Communication - ISO

7.4, 9.1.2 6 Is there a established contract review process? 1 1

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Is there a process established for customer feedback

7 related to quality, service and product reviews? 1 1
Max Score 12 Audit Score 8

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Audit Remarks

Customer specification and requirments are reviewed during

the APQP Stage. Verified : Customer Name Ashok Leyland.
Customer requirment Part No. FYJ06311 Hex Flange Screw
M20 x 1.5 x 55 Long converted to Production drawing no.
MBC1800130. Customer specific requirment is captured and
recorded in CSR sheet F-EN-23 Rev 01,Customer
code:104824 . Also Fesasibility Review is conducted Format
No. F-EN-03,Report No. DFL/RFQ/0022 ,SOP-EN-02 Rev:02
Procedure for Engineering -APQP,Product Development &
Process Design. Clause: 4.4

Customer specific requirment is captured and recorded in CSR

sheet CSR verified for Customer ASHOK LEYLAND, Customer
code 104824, CSR sheet F-EN-23 Rev 01 , SOP-EN-02 Rev:02
Clause : 4.1,4.2

ECN(Engineering Change Note),PCN(Product Change Note)

system followed.Changes notified by customer or insisted by
the organisation get reviewed and executed as per procedure
SOP-EN-02 Rev:02 Clause : 4.17 and record maintained in
Format for ECN : F-EN-01, Format for PCN: F-EN-04. ECN No.
39 is verified, where change in head marking from Unbroko
to DFL given by customer. Drawings revised and issued to
each HOD in CFT Meeting.

After the engineering change/Product change, once drawings

are revised CFT meeting is conducted and old drawing are
taken back and new revised drawings are issued. Verifed F-EN-
10 Drawing issue register

FMEA is conducted and Control plans are prepared for process

as well as product characterstics. Verified Control Plan No.
PCP/PF/HHB/006 for Bolt forging,Control Plan No. PCP/HT/05
Along with test certificate control plans are shared with
customer.

SOP-MK-01 Rev:0 clause 4.2, Format :F-MK-01 for Contract

review check list. Verified for PO No. 6010188720.

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SOP-MR-06 Rev:02 (Procedure for monitoring customer

satisfaction)Once in six months , customer feedback forms
are sent to the entire customer. Verified Customer feedback
form : F-MR-18 (Tafe Motors & Tractors Ltd)

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Max
Category Clauses # Evaluation Questions Score Guideline

Supplier
Management- Procurement
8.4.1
Specifications - ISO
1
Show me your procurement specification for your incoming material
Check dwg. And spec. revision rev for alignment 2
Purchasing

Supplier conformance - ISO 8.4.2 2 Show me how you guarantee supplier conformance of incoming 2 **This is linked to Production IQC item#1.
material to your/their specification. **This is more focused on supplier audits.

If yes and trend or Cpk data from IQC or CoCs is shared with
Do you hold regular meetings or feed back performance data to your sub-supplier, score = 2. If regular meetings are held with
5 3
suppliers? Are there supplier metrics? Do you have QBRs? supplier, but no data is presented, score = 1. If no meetings
with supplier are held, score = 0.

Supplier change mgmt 6 Is there a system and process to track and manage changes at the 2 Sub-supplier SCN process
supplier?
Supplier complaint resolution and 7 Do you feedback non-conforming material complaints to your 2 If yes score = 1, if no, or RMA non-conforming material to
tracking - ISO 8.4.3 suppliers? supplier, score = 0

Do you have a closed loop corrective action system with your If an 8D/Supplier corrective action report is required (less
8 suppliers (SCARs) in the event of non-conforming material? 2 than 8D), score = 1.

9 Do you have an automated system to track progress of suppliers 2 If automated system, score = 1, else 0
corrective actions and closure of the issue with the supplier?

Max Score 15 Audit Score

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Audit
Score Remarks

Checked Drawing No. MBS1300308 refering to 10B33(M).

Requirment are shared with the supplier in the form of
2 Technical Delivery condition in return supplier provide TDC
feasibility report against TDC.Verified TDC: 19-005 Grade
10B33(M) ,PO 3500136162 .

Supplier audits are not done. Necessary information of the

raw material suppliers and product related consumables
are obtained and capabilities of suppliers are assessed
through supplier self assessment form.Quality
management system of raw material supplier shall be
certified to iso 9001. In addition Deepak Fastners perform
1
all applicable tests on all incoming raw materials each heat
number. WI-QA-03 Rev 05 dated 01-02-2018 (Incoming
Raw material testing and sampling). Deepak fasteners
doing all process inhouse, only raw material are procured
from outside.SOP-PU-01 (Procedure for purchasing
process) Clause 4.1

Supplier performance is evaluated at regular interval, SOP-

PU-01 Clause 4.3 .Supplier performance evalution
conducted based on Delivery Performance,Quality
3 Performance etc. Verfied Supplier performance rating form
F-PU-02 dated 31-12-2020.Verifed feedback to supplier
M/s Panchmahal steel Quaterly basis.

Deepak fasteners doing all process inhouse, only raw

2 material are procured from outside.

2 Yes , Verified MOM dated 20-07-2017

SOP-PU-01 Clause 4.3.4 , Supplier 8D is required in case of

2 rejection identified during incoming inspection or any
rejection during processing of material in production.

0 Using offline mode . I,e through mail.

12

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Max
Category Clauses # Evaluation Questions
Score

Planning - Order Entry 1 How do you process an order when you receive it from FTC Solar? 1
ISO 8.1

Scheduling 2 How is the order scheduled and a delivery date determined? 1

Inventory Management 3 Based on inputs from planning and scheduling, how do you manage your 2
inventory levels?

Cycle time tracking 4 Is cycle time tracked and reviewed by production management? 2

Max Score 6

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Guideline Audit Remarks
Score

Verified PO No. 1300007631 converted in Work order

C0359 in SAP by Core Business Team, Based on the
Must have on-line system for order entry. Online system, score = 1, any 1 feasibility review by engineering team with respect to
hardcopy system, score = 0 If hardcopy system, issue OFI product,dispatch/delivery requirments formal work
order is released .SOP-PP-01.Clause : 4.1.1 to 4.1.3

SOP-PP-01 Clause 4.2.1 , Production plan is prepared by

review of previous month pendings and upcoming work
orders.All new work order of successive month is
consolidated and production plan is made based on
Online system with either manual or automated resource checks, score = 1, any 1 1)Delivery commitment,2)Raw
hardcopy system score = 0 Material,3)Tools,4)Machine capacity
utilization,5)Production Lead Time,6)Outsource
items,8)Interplant Transfer Verified work oder no.
C0330 scheduled for june delivery.

Any system (online, 5S, or manual) score = 1. No system, score = 0. If fully

automated system with full links and communications to scheduling, inventory 1 Day to day production output is verified against Raw
management, buyers, and management, score +1 - BP If no system issue minor Material Inventory utilizing SAP.
non-conformance to 7.2.2(c)

If cycle time is reviewed at least weekly by management, score = 1. If reviewed Cycle time not directly reviewed but production based
by mgmt, posted for production personnel to review, and reviewed in 2 on pre decided cycle time is daily reviewed and reviewed
management review, score +1 - BP If not tracked by management, issue OFI by management on weekly basis. Cycle time is fixed for
machines and products.

Audit Score 5

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Max
Category Clause # Evaluation Questions Score

Design and
Engineering/Produc development What is the process followed for design and development of new
1 products? What are the inputs for the features and characteristics of 4
t Development planning, inputs, your next product?
outputs - ISO 8.2

Is there a design and development review process with phase gate

Design and 2 reviews? Does this include advanced Quality Planning and provides for 3
development review change control.

Is there a documented process and plan for Design verification testing 2

and validation? Is there a hand-off to production? PVT plans etc?

Customer notification
of changes 3 Is there a customer change notification procedure 1

What is the process to document, control and manage changes during

4 the design and development process? 2

Max Score 12

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Audit
Guideline Score Remarks

Need to show the following: Inputs based on customer feedback, market

trends, best practices, etc. Score = 2, if certain attributes then 1, if no Deepak fasteners limited has system & APQP (SOP-EN-02)
customer or market based input is evident, score = 0 PROCEDURE FOR PROCESS DESIGN AND PRODUCT
4
Inputs from D-FMEA analyses. Score = 4 If no input based on discovered DEVELOPMENT.APQP process in followed for handling the
or know failure modes score = 0 and issue Major Non-conformance to inputs. Verifed APQP of Customer ID : 104824
FTCQMS Section 8.2.1

Requirement for multiphase gated system for design and development Deepak fasteners limited has system & APQP (SOP-EN-02)
review. Must have the equivalent of at least 4 phases from design inputs 3 PROCEDURE FOR PROCESS DESIGN AND PRODUCT
through to production release. Score = 3, if no system score = 0 and DEVELOPMENT.APQP process is followed for handling the
issue Major Non-conformance to ISO 8.2.2. inputs. Verifed APQP of Customer ID : 104824

Pre-Launch Production Trials are performend refer SOP-EN-

2 if process and records, 0 if not. Check the Engineering methodology to 2
validate test conditions. 02 Clause 4.13. - 4.19. Verifed APQP of Customer ID :
104824

If evident, score = 1, if no CCN procedure, score = 0, issue major non- ECN system followed.Changes addressed by engineering or
conformance to FTCQMS 8.2.1 1 product or by customer are reviewed and handeled as per
procedure and record maintained in F-EN-01.

ECN system followed.Changes addressed by engineering or

2 product or by customer are reviewed and handeled as per
procedure and record maintained in F-EN-01.

Audit Score 12

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#DIV/0!

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Max
Category Clause Question Evaluation Questions Score Guideline

Human Highlight 3 employees (1 operator, 1 maintenance, 1 manager) & ask HR to produce job
Resources - Job Descriptions 1 Are there job descriptions for all employees? 2 descriptions. Review, in detail, the maintenance job description. If all JD are adequate, score
ISO 7.1.2 = 1. If there is a career progression section of JD, score = 2

If there are training procedures, score = 1, If they require: orientation training, at least yearly
Training safety training (+1), job specific training, job specific certification, minimum passing scores
specifications and 2 Are there training procedures? 4 and/or performance levels (+1) within a specified number of attempts, reaction plan on the
procedures event of failure (+1), and at least yearly recertification for critical operations (+1).

Are there training records for employees? Paper or

Training records 3 electronic? Who owns the updates and maintenance of the 1 1 if there is a system, 0 if not
records?

For individuals on the production floor, locate at least 2 and verify that they have current
Training records Review training records and certifications. Check specifically
and certifications 4 if there is a re-certification program?
3 certifications for their position. If possible, find 1 trainee and verify that the trainer signs off
on all product manufactured by trainee. If fully compliant, score = 3, else score = 0

Max Score 10 Audit Score

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Audit Score Supplier Remarks

Verified Doc: DFL-QSM, JD for Head Quality

1 Assurance ,JD for Nut Production operator,JD for
fitter. Career Progression section not defined

Doc SOP-HR-01 Rev-02 Clause 4.5 to 4.7 address

traning procedure. Orientation/Induction tranning
provided to new employes.Yearly safety tranning is
provided as per the nature of job. After job specific
3 tranning evaluations are performed to monitor
performance level.For MPI (NDT ) Mr Dhruva
Kumar is qualified, his certification renewed every
5 years as per SNT-TC-1A. Yearly recertification is
not conducted as not required by the ASNT.

Taken on Paper and kept as a scan copy also. HR

1 department owns the record. Yes system exist.
SOP-HR-01 Rev:02

Deepak fasteners are not having any certificiation

requiremnet for the operating personel.Trainee are
2 not allowed for operations.For MPI (NDT ) Mr
Dhruva Kumar is qualified, his certification
renewed every 5 years as per SNT-TC-1A

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Max Audit
Category Clauses # Evaluation Questions Score Guideline Score

Safety - ISO 1
7.1.4, If safety policy exists, score 1, else 0. If 0 issue a minor non-
TS16949 6.4.1 Safety Policy 1 Does a safety policy exist? conformance to ISO 6.4 and TS16949 6.4.1 1
Does the safety policy promote compliance with local laws 1
2 and requirements? If compliant, score 1, else score 0 1

1
Are there any open safety issues, how are these incidents
Safety Tracking 3 tracked? Records? 0

Examples of a safety program: established safety manuals or

3 elements in the working instructions which are job specific,
posted building escape routes, posted building disaster
shelter locations, dedicated communication means for spill,
accident, and disaster notification, established ERT teams,
etc. Max Score = 3 If there are no established safety
Safety Programs and Training 4 Is there an established safety program? programs, issue major non-conformance to 6.0 and 6.4.1 3
1 Yearly training = 1, Training during orientation only = 0. If
5 Is there regular and repetitive training of safety elements? zero, issue OFI 1
1 Hardcopy systems only = 0, automated systems = 1, if 1 issue
6 Is there an automated system for tracking safety training? BP 0
Max Score 8 Audit Score 6

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Remarks

Yes, Doc No. DFL-EHSM. Issue no. 1 Dated 09-

01-2017

Yes

Incidents are recorded in formats F-EMR-08,

F-EMR-09 , Safety issues are not recorede on
daily bassis only incidents are recorded.

Safety Manual : DFL-EHSM Edition 2 Rev:0,

safety instructions are added in job specific
work instruction. Escape routes are defined,
safety drills are also conducted twice in a
year.

Yearly tranning provided.

Hard copy system

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Category Clauses # Evaluation Questions Max Score
Quality Manual Quality Manual 1 Quality manual exists and meets requirements of the std 2
- 4.2.2

Procedure and
Work Instructions 2 Is there a document control procedure? 2

Revision control 3 Do documents within the document control system, possess a revision 2
number, and is it well displayed?

4 Are edits of controlled documents, controlled such that two edits cannot be 1
Control of in progress concurrently?
Documents and
Records - ISO
4.2.3, 4.2.4

Does the DC system allow for only the latest revision to be accessed in a
5 controlled fashion? (Only QA or authorized access to obsolete documents is 1
allowed)

6 Are external documents required for the operation of the business identified 1
and their distribution controlled?

Records Retention 7 How long are production records retained? 2

Maximum Score 11

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Guideline Audit Score Remarks
Quality manual released and meets all clauses=2, meets certain clauses=1, no QM 2 Yes , verified Quality manual DFL-QSM
0 and document NC Rev:01

If there is no document control procedure, score = 0 for this whole section and SOP-MR-01, Control of documented
issue Major NC. If procedure is in place, score = 1 2 information-system procedure is
available.

If revision numbers are evident on controlled documents, score = 1, if not score = 2 Yes, Verified WI. No. : WI-QA-03
0.

Master list of documes are maintened

for current revision.After any new
If a "check-out" feature or other means by which all editors are aware of 1 ammendment documet is submited to
concurrent edits, score = 1, if concurrent edits are not controlled, score = 0. MR for its approval and release. Verified
Master list FMR-01

If obsolete documents are removed from the system for general access, score = 1, Obsolete documents are stamped
if obsolete documents are evident in any production area, or are accessible on 1 obsolete and removed from the system
the production floor, score = 0 and issue Major NC. as well as called back from user. Only
Authorised person is having access.

1 if there is a process, 0 if not 1 Yes

Only Special Product and customer

If < 10yrs, score = 0, if 10-15 score = 1, if >15yrs score = 2. 0 specific requirment records retained for
10 years.
Final Score 9

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#DIV/0!

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Category Clauses # Evaluation Questions Result

Measurement
Calibration Do you have all critical measurement and production tools on a
Calibration Systems - Systems
1
calibration program?
1
ISO 7.1.5

2 How is this calibration program managed? 2

3 How are individuals notified that "their tool" has an upcoming calibration 2
due?

4 What is the frequency of calibration and how was that determined? 2

Internal 5 If you perform internal calibrations, are your calibration standard linked 2
calibrations to a regulatory body's standards?

6 Is your lab ISO 17025 certified? 1

External If you send out tools for calibration by a third party, are they ISO17025
7 1
calibrations certified and use recognized governing body standards?

Review of 8 For internal calibrations, what are the standards used to calibrate. 1
standards

Inspect measurement tools on shop floor for certification stickers. Must

Review of 9 inspect a minimum of 3 measurement or production tools which require 2
records
calibration.
Max Score 14

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Audit
Guideline Score

If no, score = 0 for the complete section, and skip all other questions in this
1
section and issue a major NC. If yes, score = 1

Fully automated on-line system, score = 2, Manual, but effective system, score
= 1, ineffective manual system, score = 0. 1

Fully automated email notification system, score = 2, effective manual system, 1

score = 1, responsibility lies with the individual, score = 0

Smart, adaptive system, score = 2, frequency based on manufacturers 2

recommendation, score = 1. If no determined frequency, score = 0

If yes, score = 1, if no score = 0, +1 if all calibrations are done internally (to 2

compensate for scores possible with external calibration systems)

If yes, score = 1, if no score = 0 0

If yes, score = 1, if no score = 0, if only external calibrations are done score = 3

1
(compensates for scores possible with internal calibration systems)

If standards reference to certifying body standard, score = 1, if not, score = 0 1

and score CAL5 = 0.

If all stickers current, score 2. If 1 sticker not current, inspect additional

stickers and score = 1. If 2 stickers are found not current or indicate that tool 2
is out of calibration, score = 0
Audit Score 11

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Category Clauses # Evaluation Questions Result

Quality Internal Audits - 1 Do you perform and is there evidence of internal audits? 1
Assurance ISO 9.2

2 Are individuals trained in internal audits? Is there a internal audit calendar? 2

Audit results 3 Are there written internal audit reports which are submitted to management? 1

Corrective actions -
4 Are corrective actions identified and closure of actions tracked? Is this a closed loop system? 2
ISO 10.2

Customer 5 Is there a system and window for the customer to accept and acknowledge complaints? 1
Complaint Systems

6 How soon must the supplier acknowledge the customer complaint/concern/information request? 1

Is there an automated system which customer service, sales, or quality enter the customer
7 complaint, and automated emails are sent to the source location for the initiation of analysis? 2

8 Are complaint metrics (number of complaints, time to close with customer, time until verification 2
of CAPA, etc.) tracked and reported in mgmt review?

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8D/Root Cause Is 8D the accepted method of reporting for internal complaints, external complaints, and other
Reporting 9 internal manufacturing issues? 2

Corrective Actions 10 Are corrective actions identified and closure of actions tracked? 1
- ISO 10.2.1 a

RnO update - ISO 11 Is there a need to update risk and opportunities determined during planning or make changes to 2
10.2.1e 10.2.1f QMS? if necessary.

Effectiveness of Are repeat events designated, highlighted to management, and tracked as a quality metric in
CAPA/Repeat 12 2
Issues management review?

Continuous
13 How does the organization continually improve the effectiveness of the QMS through the analysis 3
improvement - ISO of data?
10.3

Max Score 22

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Audit
Guideline Score Remarks

Internal Audit Performed yearly once.Audit Plan F-MR-08

Rev.00, Verified audit cycle No. 32, Internal System Audit
If yes, score = 1, if no score = 0 1 schedule , Audit report of production department
dated16-07-20 Minor NC was reported NCR No. PB-01, IN
all 47 minor NCs was recorded and closed covering 18
departments.

Verified Internal Auditor Name Jason Joseph Tranning

2 Record & Audit Plan F-MR-08 Rev.00

Yes addressed in MRM , MRM No. 14 dated 23rd Sep

If yes, Score = 1, if no score = 0 1 2020

NCR No PB 01 verified, Corrective action identified as

tranning to the operator about the importance in the
If corrective actions are identified from internal audits, score = 1, if CAPAs are tracked within the quality system & same is closed after providing tranning.
2
quality CAR system, score = +1, if no CAPAs are identified or tracked score = 0. SOP-MR-04 (Procedure for internal audit) Audit Nc
Sumarry is verified and same is monitered by MR for
closure.

If customer has an interface, either through customer service, sales, or quality management, score One dedicated person Marketing associate who
= 1, if customer must call the general number for the supplier, score = 0 1 cordinate with customers regarding complaints is
If there is no dedicated person to handle FTC related issues, issue a major NC. available . (Mr. Gursewak Singh)

SOP-QA-03 Rev 01 (Procedure for handling customer

If within 48hr of notification, score = 1, any longer score = 0 1 complaints). Verifed few customer complaints and found
acknowledged with in 48 hours. (But no time line
defined in SOP)

If there is a system, but it is manual, score = 1. If the system is automated, score = 2, if no system SOP-QA-03 Rev 01 (Procedure for handling customer
score = 0 1 complaints) is followed. System is manual

If metrics are compiled and reviewed by quality dept. score = 1, if quality department reports Customer Complaint Register verified Format No. F-QA-
2 39 Rev 00 & same is reported, discussed in MRM No. 15
metrics in management review, score = 2.
Dated 18th March 2021 verified

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If 8D is used, score = 1. If additional problem solving methods, as appropriate, are used (Is/Is Not, SOP-QA-03 Rev 01 Clause No. 4.3 for external
Fishbone diagram, root cause model table, 3 way 5 why, etc.) score +1. If a method other than 8D complains,SOP-QA-02 Rev:01 Procedure for control of
is used, it must contain the following elements to score =1; root cause analysis, root cause non conforming products refers 8D as a accepted
identification, containment actions, corrective action identification, corrective action method. Verified Inhouse rejection Corrective &
implementation, preventive action implementation, and verification of the effectiveness of 2 preventive action report dated 10-02-2021 for the part
implemented corrective actions. Also check for effective implementation of CAPA - proper RCCA, 5011804 root cause analysis done through Why Why
PA etc analysis. Verified 8D for the Part No 816318 for external
If Supplier do not have any equivalent problem solving tool, issue a major NC. complaints.

If CA are identified and tracked through implementation, verification, and effectiveness evaluation, 1 Verified CA for PB-01, System adherence is verified on
score = 1, else score = 0 random machines after CA implemented.

If PA are tracked through implementation and verification, score = 1. If the FMEA is updated to For Customer complaint no. SPM-June-0320 Preventive
2 action is identified and implemented , in addition PFMEA
reflect the enhancements due to the CAPA, score = +1
is also revised evident in PFMEA 030 Rev:03.

If repeat events are designated, score = 1, if they are further highlighted to management as a Verifed MRM Mo.15 . Defect analysis is conducted on
2 monthly basis using pareto, Why Why analysis. Same is
quality metric tracked during management review, score +1 discussed in MRM .

SOP-MR-07 clause 4.1 Procedure for data analysis &

continual improvement . List of continual improvement
projects verified. Target set for 12 projects per annum.
3 Inhouse rejection trend analysis conducted monthly
using tools like pareto , why why analysis and corrective,
preventive actions identified. Verified Inhouse rejection
trend for the month of april 2021. In April month set
targets are achieved.

Audit Score 21

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Category Clauses # Evaluation Questions Max Score Guideline

Leadership Quality Policy - 1 Is there an established Quality Policy under document control? (5.2.2) 1 If yes score 1, if not or if not in DC score 0 and write up minor
Section 5 ISO 5.2 non-conformance.

Includes a) Has the Top management established, implemented & maintained a

Customer 2 Quality policy that is consistent with the purpose and context of the 1 1 if yes, 0 if no
Satisfaction organization and its strategic direction?(5.2.1)

3 Does the quality policy includes commitments to satisfy any applicable 1 1 if yes, 0 if no
requirements s? (5.2.1)
In reviewing the QP document, is there commitment to comply and
4 continuously improve? (5.2.1) 1 1 if yes, 0 if no

5 Does the QP provide a framework for reviewing quality objective? (5.2.1) 1 1 if yes, 0 if no

6 Is the QP displayed and communicated to all employees? (5.2.2) 1 enter 1 if yes, 0 if no If not displayed, issue OFI
7 Is the QP regularly reviewed by top management? (5.3) 1 enter 1 if yes, 0 if no If not displayed, issue OFI

8 Overall Quality Policy Implementation 2 If 3 or less of Q2-7 are yes, then 0, if 4-5 are yes, score 1, if all
yes, score 2

Response should not directly quote QP. Management response

should include: customer focus, commitment to quality, and
Specific question during audit: Ask factory manager or other non-quality continuous improvement. Employee response should include:
9 management representative and at least 1 other employee: "What does 1 execution to quality systems, recognizing out of compliance
the quality policy mean to you?" (5.2.2c) product, and responsibility to inform management/engineering
of non-compliant materials or abnormal conditions. Score 1 for
management correct response. Score 1 for employee correct
response.

Management Are there management communications systems (production status

Communications - 10 boards, quality policy postings, top customers, results of management 1 If no communication score 0, based on response and evidence of
ISO 7.4. meetings communicated to all through group or shift meetings, etc.) communication, score fractionally from 0-1. Max score = 1

Does top management hold regular "town hall" or "all hands" meetings to Only if top management holds regular "all hands" meeting score
11 communicate the state of the site, division, or company? 1 = 1, else score = 0 "All hands" meetings are best practice.

Management 12 Are there a Risk-based thinking way and the adoption of the process 1
Review - ISO 9.3 approach during management review? Such as SWOT analysis.

If management review is held score 1, else 0. Elements of MR

13 Does the organization hold management review? 1 scored later

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If yearly score 0, if 2x per year score 1, if quarterly or more score

14 Frequency of management review 2 2. Note: If individual elements of management review are
reviewed by management more frequently, use that frequency
for scoring.

Review at least two minutes (documents) from management review.

15 Match the actions from the first MR with the initial proceedings from the 2 If continuity in MR score 1, else 0.
second MR. This proves continuity.

Review action items from previous management review and ask for
16 objective evidence of closure. Also, check for improvement of 1 Review evidence of closure
effectiveness of QMS and products related to customer requirements

Management review shall include the following site metrics as a

minimum: the changes to context (internal/ external issues) of the Score as follows for the following being reviewed:
organization that are relevant to its QMS, production performance, yield Production performance, yield/rework = 1
17 or rework rate, results of audits (internal and external), status of CAPA 4 Customer complaints/feedback = 1
from previous MRs, customer feedback and complaints, KPIs for critical Critical process KPI's = 1
processes, repeat complaint/non-conformances, and cost of poor quality, cost of poor quality = 1
adequacy of resources required for maintaining an effective QMS, Max score = 4 (CAPAs and repeats scored in Quality section)
opportunities for improvement.

18 Are MR minutes, results, and actions maintained as a record and tracked 3 Fully automated system score +3, if hardcopy only score +1, if not
in an automated system or is the system hardcopy only? minutes, score = 0

If site metrics are communicated through shift or weekly

Site Metrics - ISO 19 Are site metrics communicated to all employees? 2 meetings by management, score 1, if site metrics are posted
7.4. (production performance, scrap, rework, yield, safety events,
etc.) score 2.
ISO 9.1.2
Customer 20 What is the process to track, manage and improve customer satisfaction? 2 On-line (Survey Monkey), self, 3rd party
Satisfaction
Max Score 30 Audit Score

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Audit Score Remarks

1 Yes, Verified Quality Policy .Document No. DFL-QSM,

Rev:01

1 Yes

1 Yes

1 Yes

1 Yes

1 Yes
1 Yes , Verified MRM No.:15 dated 18th March 2021

Mr Anup Sakalley (Manager Maintenance) questioned

1 about Quality Policy and response is satisfactory.
Mr Suneet Kampharia (Executive Heat Treatment Process)
responded satisfactorly.

Performance of individual departments are displayed at

Display Boards.Diplay boards are also available at
1 machines. During shift change every day meeting is held
by supervisour.Quality policy displayed at shop floor
areas.

0 No

1 Yes, Verifed MRM No. 15 , Dated 18th March 2021. Serial

No. 03

1 Yes,

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Verifed MRM No. 15. SOP-MR-03 .Management review is

conducted at frequency of once in six months. Verified
1 MRM calander updated on march 2020. (weekly , monthly
quaterly review meetings are conducted regularly for
individual department on key elements.

2 Verified MRM No. 14 and 15. Contunity observed.

Methonal storage planning discussed in MRM No. 14 and

observed completion of work in MRM No. 15. Process
1 performance and product conformity is discussed in
MRM, Discussion on the department wise status of
production plan vs achieved and rejection trend is
reviewed and discussed.

Verified monthly data for :1)Production performance ,

4 2)Customer Complaint 3)Cost of poor quality3) Critical
process KPI's

1 Hard Copy Only

2 All dept KPI metrics are displayed in the shop gallery to

communicate to all employes

2 Self.SOP-MR-06 Procedure for monitoring of Customer

Satisfaction is exist in place.

26

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Max
Category Clauses # Evaluation Questions Score

Product Realization - IQC - ISO 9.1.1 1

What is the process to verify purchased product against specification, P/N and
2
Shop Floor - IQC qty?

2 Do you perform IQC ? 2

3 Do you perform IQC on critical components and materials 6

Traceability of supplied 4 Are all supplied materials traceable? Show me the system which tracks the 3
materials supplied materials and how they are traced through the production flow.

Show me in your system how non-conforming supplies are segregated to

Segregation of non- 5 prevent use in the product. Is there a material review board to disposition such 5
conforming product material?

Preservation of product 6 Look throughout warehouse to guarantee no water damage, no crush damage, 1
no leakage of liquids onto other supplies or shelving, etc

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IQC Data trending and 7 Is IQC data analyzed more than just trending? 3
SPC

Max Score 22

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Audit
Guideline Score

Must log supplies with a serial number (either internal or suppliers) into an
automated inventory management system. If supplier, date, and lot number are
traceable score = 2, if supplies are in a manual 5S or inventory management 1
system score = 1, If no system score = 0 and issue a major NC.

Check for data and CoC 1

Check for data and CoC 6

If supplies are traceable throughout the production flow, score = 3. If supplies are
traceable through warehouse and failing material is segregated in the system, 3
score = 1. If supplies are not traceable, but only inventory levels are monitored,
score = 0.

If segregated in the system and effectively removed from production inventories,

score = 3. If non-conforming materials are segregated into a locked and controlled
room or area, such that production does not have access to these materials, score 4
= +2. If non-conforming material is placed in a well marked and separated area
away from conforming material, score = +1. If no system, score = 0 and issue major
non-conformance for ISO 8.7

If supplies are stored and transported such that they will arrive on the production
floor undamaged, score = 1, else score = 0 and if pervasive, issue minor non- 1
conformance to ISO 7.1.4.

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If there are distributions, Cpk's or other statistical analyses (or if SPC is statistically
valid) which engineering is reacting to, score = 3 and issue BP, if no further analysis, 1
besides trending, score = 0.

Audit Score 17

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Category Clauses # Evaluation Questions Max Score

Product
Realization - Work Instructions and 1 How do technicians/operators on shop floor know to do their job? 5
Shop Floor - Compliance - ISO 8.5.1
Production

2 If there are hardcopy work instructions, verify that the revision is 2

the latest revision in document control system

Is there a system by which you trace product through the

Traceability of product - 3 production line? Review at least two workstations on the 7
ISO 8.5.2 production floor for traceability systems. Score the parametric
data entry separate for each of the two areas reviewed.

Are all individuals working on the product trained and certified to

4 work on the product, or is there a trainer who is fully responsible 2
for the compliance of said trainee?

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Observe at least two technicians/operators processing product per

the work instructions. Inspect the work, watch closely the order in
which they complete the work, and review specifics of the work,
5 such as torque wrenches, cable sizes, soldering quality, etc. Check 6
for porper and adequate process controls in prodution. This should
part of overall prodcution review and scoring

Observe product flow, is there a chance of mix up between

6 processed and finished material at a work station? What is the 2
shift change process?

Is the product protected from, excessive heat, moisture exposure,

Preservation of product - corrosive or caustic materials, excessive rework, electronic
7 discharge, mechanical damage (from dropping, other materials, 6
ISO 8.5.4 product, or supplies falling onto product, etc.), hand or skin oils,
etc. 5S systems?

Segregation of non-
Is non-conforming material moved out of the production flow for
conforming product - 8
MRB review?
3
ISO 8.7

Production data trending 9 Is production parametric, or step conformance testing results 2

and SPC - ISO 9.1 trended and controlled under SPC?

Max Score 35

Special Note/s:
1. Need to audit critical processes - tube fabrication, punching/stamping & welding process; check work instruction and skill of workers

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Audit
Guideline Score Remarks

Technician/operator must reference latest revision of work instructions (either on-line

or hardcopy). Assess work instructions for ease of use and revision integrity. BP WI use
color coding, contain clarifying pictures, indicate specific requirements (torque settings, Verified Work instruction WI-HT-02 Rev 02 for Dephosphate
wire gauge, etc), and contain step by step instructions indicating the order in which 5 Process and inspection, WI-PK-02 for Label on the material packing
work is to be carried out. Start with score = 5 and follow: No pictures = -1, no color or box. Wrok instruction is detaild , in dual language , included colour
other clarifying indicators for connections = -1, WI lacking specific requirements = -1, pictures for better understanding.
lack of step by step instructions = -1, lack of shop drawings = -1. If no WI, score = 0.
Min score = 0. If score = 0, issue minor non-conformance to FTCQMS 8.5.1

If hardcopy (or referenced softcopy) WI are latest released revision, score = 2, if 2 Verified Work instruction WI-HT-02 Rev 02 at shop and found latest
obsolete version, score = 0 and issue minor non-conformance to ISO 8.5.1. revision as per the Master list of documents

SOP-QA-05-Procedure for Identification & Traceability is

documented and followed. Traceability of product is ensure with
the unique batch number at stage of process and it is chained with
On line production flow system is required. Details that the system must include are: next stage of process. Flow of traceability from product to raw
Process step, date of process step (begin and end), operator(s) working on product at material is ensured. traceability batch number is evident in log
step, supplies used by part number and lot number, individual parametric data, specific book records.All details are recorder in Production Log Book &
critical equipment serial number, production comments, requirement for MRB and/or 7 Quality assurance chart FPB-06 Production Log Sheet,Quality
rework. Start with score = 6 and follow: No process step identified = -1, no dates of step Assurance assurance chart FQA-03 for Forging Verified Quality
= -1, no operator numbers = -1, no supplied materials lot number = -1, no indication of assurance Chart & Production Log book for Part No. 5000131,
MRB and/or rework = -1, no comments = -1. If there are parametrics measured and Description M16x75 HSS, Grade A270 , Operator Name Arjun
they are recorded in the system score +1. Verma dated 05-06-2021.
For Heat Treatment log Boot F-HT-01 .
Verified Part No. 119790 M6x 20 SHCS, Grade 12.9 Heat No.
C71744, Operator Jitendra Parmar.

No special certification requiret for heat treatment/Forging. NDT

If all individuals are certified or are trainees under the responsibility of a trainer who is person is Certified. Employee competency is evaluated thrugh skill
also responsible for the compliance of the trainee to the work instructions, score = 2, 2
matrix form and where the training need is identified and planned
else score = 0 and issue OFI or Minor NC for FTCQMS 7.2 for training. Records maintained.

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Is the operator/technician executing the work instructions accurately and completely?

If the operator/technician is executing accurately, all aspects of the work instructions, Yes, For heat Treatment process interviewed Mr Sunit Kampharia
score = 5. If the operator is not executing exactly to the work instructions, but is responsible for furnance control, he has good understanding of his
achieving the desired end-of-step result, score = 1. If the operator can explain the work 6 work , roles and responsibility and work instruction.
they are doing and how the work instructions provide for the optimum result of the For Forging Interviewed Mr Gaurav . He found working as per
product score +2. If execution is poor for whatever reason, score = 0. workinstructions and compliance.

All operatins are performed through Multi stage advanced

automated machines hence the forging has no chance of skiping of
any operation. To ensure the correct material quality bucket
system intermidate checking frequency and material identification
2 tag system is followed. SOP-QA-05. J ok stamp is verified at forging .
Heat Treat is a continius furnance matrial are loaded at the input
stage and processed as per the process Flow in covered furnance
then material in unloaed after the process at other end. Verified H
OK Stamp. SOP-QA-05

If operators are dissipating any electrical charges through the use of ESD protection
footwear and/or wrist straps, score = +5. If product is protected from corrosive ESD is not applicable at Deepak Fasteners.Soft pads are used to
materials, the work station is well configured to minimize damage from other sources, 5 collect the product (fasteners) from coveyor chute so that the
and there is no evidence of damage due to excessive rework, score = +1. Minimum product protected from thread damage. 5s maintained in the
score = 0, max = 6 If no ESD protection, issue major non-conformance to FTCQMS 8.5.4 machine/ work zone.

If non-conforming material is immediately reworked or moved effectively out of the

production flow and is in a well marked area with the status of the product clearly
visible, score = 2, if the segregation area is not well marked or the status of the product Non conforming material is immediately quarantined from the
is not clearly visible (resulting is a risk to the product being introduced back into the 3 production line, kept in a locked area and reviewed for disposition
production flow without appropriate disposition) score = 0 and issue a major NC. If action. This area is under control of QA.
non-conforming material found on the production floor is segregated into a locked
room, controlled only by QA, score +1, BP.

Where applicable, if parametric data is logged and trended, score 1, if SPC is applied, 2 Verified Quality Assurance Chart for Forging.Part No. 5000131,
score = 2, if data is collected or logged but not otherwise analyzed, score = 0. Description M16x75 HSS, Grade A270

Audit Score 34

truction and skill of workers

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Category Clauses # Evaluation Questions Max Score Guideline

Product Test Area

Technician/operator must reference latest revision of work instructions (either on-

line or hardcopy). Assess work instructions for ease of use and revision integrity. BP
WI use color coding, contain clarifying pictures, indicate specific requirements (order
Product Work Instructions and of initial verification testing and tool settings, etc.), and contain step by step
How do technicians/operators on shop floor know to do
Realization - Shop Compliance - ISO 1
their job?
5 instructions indicating the order in which testing is to be carried out. Start with score
Floor - Test 7.5.3.2 = 5 and follow: No pictures = -1, no color or other clarifying indicators of test points =
-1, WI lacking specific requirements = -1, lack of step by step instructions = -1. If no
WI, score = 0. Min score = 0. If score = 0, issue minor non-conformance to FTCQMS
7.5.3.2

If there are hardcopy work instructions, verify that the If hardcopy (or referenced softcopy) WI are latest released revision, score = 2, if
2 2 obsolete version of WI or test program is referenced, score = 0 and issue minor non-
revision is the latest revision in document control system conformance to ISO 7.5.3.2.

Test program or procedure revision must be clearly identified in the work

How does the tech/operator know which revision of test instructions. Based on varying models and requirements, the test program revision
program or test procedure to follow? IF automated test, must be indicated on the run card or WIP system. If revision is clearly indicated in
3 is download and verification of latest test program 2 the work instructions and on the run card or WIP system, score = 2, if WI indicate
automated/central control or manual correct revision, but is not on run card or WIP system, score = 1. If revision to be
used is unclear and not poke yoke'd, score = 0 and issue non-conformance to
FTCQMS 7.5.3.2.

Show me how you trend, apply SPC, or otherwise If no trending or other data analysis, score = 0, if data is trended only, score = 1. If
Test data trending and 4 analyze the test data for capability, trends, and react to 3 capability analysis and screening to spec is evident, score = +1. If SPC is applied,
SPC - ISO 9.1.1, 9.1.3 identified issues. and/or capability analysis, engineering review, and reaction plans are in place for
non-compliant materials, score +1. Max score = 3

5 Are there rules and a procedure for re-tests? 1

If the reaction plan is to simply submit unit for rework, score =1. If failure mode is
6 Show me your reaction plan for units failing test. 4 investigated and fed back into FMEA, score +3. If no reaction plan for non-complying
material at test, score = 0

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Segregation of non- When you have failures at test, how do you segregate Generally, inverters are reworked immediately. If test failure, rework, and passing
conforming product - 7 this material so that it does not get mixed in with 3 results are noted in WIP tracking system and this data is traceable and extractable
ISO 8.7 passing units? from the system, then score = 3, else score = 0 and issue a major NC.

Max score 20 Audit Score

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Audit
Score Remarks

Verifed WI for Salt Spray Test WI-QA-

33, WI is well defined, proper pictures
5 are used for understanding, specific
requirments are included.
Verified WI for Thread Pals Checking
WI-QA-31

WI-QA-33 Rev . 03 , WI-QA-31 Rev.01

5 Verified with master list of documents
and found latest

Deepak Fatners Implemented Control

2 Plan and drawing to ensure that
quality inspections for the product

Verified Process capability study report

for head thickness 18.02.21, WI-QA-
3 09 Work instruction For SPC. Process
capability study conducted monthly
Dimensional Characterstics

Yes WI-QA-04 Sampling plan for

1 Product quality audit states retest
rules sampling plan.

reaction plan is given in the control

plan and followed when needed.
Yellow Tag (Rejected Tag Product )
4 Includes Corrective action , preventive
action & if needed feedback given to
FMEA. For Across Flat over/under size
PFMEA/006 revised on date 16-10-
2020

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Failure/ non conforming parts are
identified with yellow tag and
quarantined from the OKAY parts. WI-
QA-04 is followed
20

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Max
Category Clauses # Evaluation Questions Score

Control of NCM - 1 Do you have an MRB/DRB system to disposition questionable 1

ISO 8.7 materials/supplies/product

Abnormal 2 Is there an abnormal condition program? 1

Conditions

Control of Non
Conforming Product
Control of NCM 3 1
product

When an abnormal condition is detected or a questionable

Reaction Plans 4 product/supply/or materials are detected, is there a documented 1
reaction plan?

If NCM is to be used, then what is the process, how is this

Use of NCM 5 1
decision documented?

Max score 5

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Audit
Guideline Score

Evidence of engineering review and disposition signoff by engineering, 1

production, and quality, score = 1, else score = 0

Do shop floor staff have the ability to shut down the production line if an 1
abnormal condition is detected? If yes, score = 1, if no, score = 0.

Who has keys to the NCM cage/holding area?

Does the factory have a defined NCM cage/holding area? If none, do they
have an effective procedure for segregating and identifying non conforming 1
material? How do they ensure the non conforming material is not used for
production.
If supplier has no procedure, issue a major NC.

If yes score = 1, if no score = 0. 1

NCM=non-conforming material 1

Audit Score 5

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Max
Category Clauses # Evaluation Questions Score Guideline

Reactive
Maintenance - Maintenance Is there a system by which the learning's/data from tool repairs If no system for the formal incorporation of learning's from maintenance
- 1 (failure modes, common repairs, updates to PM procedures, etc.) are 2 activities, score = 0. If learning's are fed back into the PM system, spares are
ISO 8.5.1 Learning's fed back into the PM system? ordered based on maintenance history, etc. Score = 2

Preventive If there is an automated PM system which notifies maintenance of upcoming

Maintenance - 2 Are critical tools on a preventive maintenance schedule? 2 PMs, score = 2, If the PM schedule is manual, score = 1, if no PM system, score
Learning's and = 0 and issue a major NC.
Records **At the minimum, supplier/factory should have a maintenance program.

Is there a system to extend the time between PMs based on If production can manipulate the PM dates, score = 0, if the PM schedule is set
3 2
production needs? If so, what is the process? by maintenance and is generally not delayed for production reasons, score = 2

Predictive If yes, score = 2 BP, if no maintenance history data is reviewed to adjust PM

Maintenance 4 Is maintenance history and PM data used to adjust the PM schedule? 2
schedules, score = 0.
Systems
Max Score 8 Audit Score

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Audit
Score Remarks

SOP-MT-01 follwed,clause 4.2 , PM check listed

revised based on the learnings from failure, latest
revison of Preventive maintenance list is 03. SOP-
2 PB-02 is followed, Tool life data is monitored based
on No. of pieces manufactured and frequency is
monthly.

1 Verified PM plan format F-MT-04.

PM schedule is followed as planned.PM schedule is

2 set by maintenance and is generally not delayed for
production reasons

2 History card is maintained for every machine.Data is

reviewed to plan the PM with respct to the actions.

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