Doc.

No: QMD-F-04
Rev. No: 2 NC REPORT Page 1 OF 2
Rev. Date: 23.12.2019

Auditor : NCR No. :01

Department / Auditee Name : Production-Assembly Date : 10.01.2020

objective Evidences :

Process parameter monitoring sheet-Identification for frequency on gun shows 20KHz control plan shows 35 KHz.Air pressure not measured in Start up checksheet.

Treated as minor as other process parameters are recorded and process validation reports found adequate.No impact to product conformity.

Details of non-conformity : .
Process of monitoring & measurement of manufacturing process was not effective.

Requirement : 9.1.1.1

9.1.1.1 Monitoring and measurement of manufacturing processes The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to
provide additional input for process control, including those for special characteristics. NOTE For some manufacturing processes, it may not be possible to demonstrate product compliance through process capability. For those
processes, alternate methods such as batch conformance to specification may be used. The organization shall maintain manufacturing process capability or performance results as specified by the customer's part approval
process requirements. The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented, including adherence to the following: a) measurement techniques; b) sampling plans; c) acceptance
criteria; d) records of actual measurement values and/or test results for variable data; e) reaction plans and escalation process when acceptance criteria are not met. Significant process events, such as tool change or machine
repair, shall be recorded and retained as documented information. The organization shall initiate a reaction plan indicated on the control plan and evaluated for impact on compliance to specifications for characteristics that are
either not statistically capable or are unstable. These reaction plans shall include containment of product and 100 percent inspection, as appropriate. A corrective action plan shall be developed and implemented by the
organization indicating specific actions, timing, and assigned responsibilities to ensure that the process becomes stable and statistically capable. The plans shall be reviewed with and approved by the customer, when required.
The organization shall maintain records of effective dates of process changes.

Proposed disposition : Horizontal Deployement of disposition :

Responcibility /Targate Date : Responcibility /Targate Date :

Attribution : Product Audit/ Process Audit /IATF/EMS/OHSAS Clause No: 8.5.1

Sign of Auditor :

Root Cause (Use Why-Why Analysis) :

Why Problem not detected ? Why did the Problem occure? Why did system fail to Prevent this problem ?
Why : Why Why

Why Why Why

Why Why Why

Why Why : Why

Why Why Why

Root Cause : Root Cause : Root Cause :

Proposed Corrective action : Proposed Corrective action : Proposed Corrective action :

Responsibility/Targate Date : Responsibility/Targate Date : Responsibility/Targate Date :
Proposed Horizontal Deployment : Proposed Horizontal Deployment : Proposed Horizontal Deployment :

Responsibility/Targate Date : Responsibility/Targate Date : Responsibility/Targate Date :

Proposed Preventive Action : Proposed Preventive Action : Proposed Preventive Action :

Responsibility/Targate Date : Responsibility/Targate Date : Responsibility/Targate Date :

Date:
Follow Up Audit (Verification for Implementation):

Verification of disposition :

Verification of Corrective action :

Verification of Preventive Action :

Documents Updation & Verification

Documents Updation Verification Documents Updation Verification Documents Updation Verification

Process Flow Diagram □ □ Packaging Sign Off □ □ Incoming Material Control Plan □ □
PFMEA □ □ Jig/ Fixture Drawings □ □ Final Insp.Checkpoints □ □
Control Plan □ □ BOM □ □ Firewall Insp.Checkpoints □ □
Product Drawing □ □ Approved Supplier List □ □ SOP □ □
Inspection Report □ □ Training Records □ □ Startup/Setup Checklist □ □
Process Validation Report □ □ Lession Learn (TGW/TGR) □ □ Supplier PSW □ □
Other Documents if any
Processing Sheet □ □ Preventive Maintenance Checksheet □ □ □ □
Status of Horizontal Deployment : Verification of NCR Status by Management Representative

Sign of Auditor:
Hence NCR is : Closed / Not Closed Date:

Effectiveness Monitoring (After 03 month & Next consecutive audit)

Effeciveness Monitoring Remark by MR Sign & Date of MR

Corrective action is found to be : Effective/Not Effective

Doc. No:
Rev. No:
Rev. Date:

Auditor :

Department / Auditee Name : Production-Moulding

objective Evidences :

Refer control plan-CP/MM/S201/090. & ultrasonic welding process.Weld quality control method an

Treated as minor as checking for weld quality and use of correct tool is implemented,hence no con

Details of non-conformity : .
Control plan development process was not effective.

Requirement : 8.5.1.1

Proposed disposition :
Proposed disposition :

Responcibility /Targate Date :

Attribution : Product Audit/ Process Audit /IATF/EMS/OHSAS Clause No: 8.5.1

Sign of Auditor :

Why Problem not detected ?

Why :

Why
Why

Why

Why

Root Cause :
Proposed Corrective action :

Responsibility/Targate Date :

Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Proposed Preventive Action :

Responsibility/Targate Date :

Date:

Verification of disposition :

Verification of Corrective action :

□

Verification of Preventive Action :

Documents
Process Flow Diagram

PFMEA

Control Plan

Product Drawing

Inspection Report

Process Validation Report

Processing Sheet

Status of Horizontal Deployment :

Hence NCR is : Closed

Effeciveness Monitoring Remark by MR

Corrective action
 QMD-F-04
2
23.12.2019

ction-Moulding

0. & ultrasonic welding process.Weld quality control method and use of hand tool for fixing of riblock not men

eld quality and use of correct tool is implemented,hence no concern to product quality.

was not effective.

8.5.1.1 Control plan The organization shall develop control plans (in accordance with Annex A) at
those for processes producing bulk materials as well as parts. Family control plans are acceptable
launch and production that shows [inkage and incorporates information from the design risk analys
organization shall, if required by the customer, provide measurement and conformity data collected
controls used for the manufacturing process control, including verification of job set-ups; b) first-off
defined by both the customer and the organization; d) the customer-required information, if any; e)
not statistically capable. The organization shall review control plans, and update as required. for an
occurs affecting product, manufacturing process, measurement, logistics, supply sources, product
corrective action, when applicable; i) at a set frequency based on a risk analysis. If required by the
Audit /IATF/EMS/OHSAS Clause No: 8.5.1

Root Cause (Use Why-W

oblem not detected ?
Follow Up Audit (Verifi
 Documents Updation & V

Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
 □ □

Hence NCR is : Closed / Not Closed

Effectiveness Monitoring (After 03 month
by MR

Corrective action is found to be : Effective/Not Effec

 NC REPORT

ontrol method and use of hand tool for fixing of riblock not mentioned.

ted,hence no concern to product quality.

n shall develop control plans (in accordance with Annex A) at the system, subsystem, component, and/or m
materials as well as parts. Family control plans are acceptable for bulk material and similar parts using a com
nkage and incorporates information from the design risk analysis (if provided by the customer), process flow
customer, provide measurement and conformity data collected during execution of either the pre-launch or
process control, including verification of job set-ups; b) first-off/last-off part validation, as applicable; c) meth
e organization; d) the customer-required information, if any; e) specified reaction plan (see Annex A); when
zation shall review control plans, and update as required. for any of the following: f) the organization determi
ring process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA)
) at a set frequency based on a risk analysis. If required by the customer, the organization shall obtain custo
 Root Cause (Use Why-Why Analysis) :
Why did the Problem occure?
Why

Why
Why

Why :

Why

Root Cause :
Proposed Corrective action :

Responsibility/Targate Date :

Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Proposed Preventive Action :

Responsibility/Targate Date :

Follow Up Audit (Verification for Implementation):

 Documents Updation & Verification

Documents
Packaging Sign Off

Jig/ Fixture Drawings

BOM

Approved Supplier List

Training Records

Lession Learn (TGW/TGR)

 Preventive Maintenance Checksheet

R is : Closed / Not Closed

Effectiveness Monitoring (After 03 month & Next consecutive audit)

rective action is found to be : Effective/Not Effective

 NC REPORT

of riblock not mentioned.

with Annex A) at the system, subsystem, component, and/or material level for the relevant manufacturing sit
s are acceptable for bulk material and similar parts using a common manufacturing process. The organizatio
design risk analysis (if provided by the customer), process flow diagram, and manufacturing process risk ana
mity data collected during execution of either the pre-launch or production control plans. The organization sh
et-ups; b) first-off/last-off part validation, as applicable; c) methods for monitoring of control exercised over s
mation, if any; e) specified reaction plan (see Annex A); when nonconforming product is detected, the proce
as required. for any of the following: f) the organization determines it has shipped nonconforming product to
sources, production volume changes, or risk analysis (FMEA) (see Annex A); h) after a customer complaint
If required by the customer, the organization shall obtain customer approval after review or revision of the co

Horizontal Deployement of disposition :

 Horizontal Deployement of disposition :

Responcibility /Targate Date :

Use Why-Why Analysis) :

the Problem occure?
w Up Audit (Verification for Implementation):
nts Updation & Verification

Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
 □ □
Verification of NCR Status by Management Representativ

(After 03 month & Next consecutive audit)

tive/Not Effective
 Page

ponent, and/or material level for the relevant manufacturing site and all product supplied, including
parts using a common manufacturing process. The organization shall have a control plan for pre-
er), process flow diagram, and manufacturing process risk analysis outputs (such as FMEA). The
he pre-launch or production control plans. The organization shall include in the control plan: a)
pplicable; c) methods for monitoring of control exercised over special characteristics (see Annex A)
Annex A); when nonconforming product is detected, the process becomes statistically unstable or
anization determines it has shipped nonconforming product to the customer; g) when any change
analysis (FMEA) (see Annex A); h) after a customer complaint and implementation of the associated
shall obtain customer approval after review or revision of the control plan.

on :
on :

Why did system fail to Prevent this problem ?

Why

Why
Why

Why

Why

Root Cause :
Proposed Corrective action :

Responsibility/Targate Date :

Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Proposed Preventive Action :

Responsibility/Targate Date :
 Documents
Incoming Material Control Plan

Final Insp.Checkpoints

Firewall Insp.Checkpoints

SOP

Startup/Setup Checklist

Supplier PSW
 Other Documents if any

Verification of NCR Status by Management Representative

Sign of Auditor:
 1 OF 2

NCR No. :01

Date : 10.01.2020

manufacturing site and all product supplied, including

s. The organization shall have a control plan for pre-
process risk analysis outputs (such as FMEA). The
e organization shall include in the control plan: a)
exercised over special characteristics (see Annex A)
tected, the process becomes statistically unstable or
ming product to the customer; g) when any change
tomer complaint and implementation of the associated
revision of the control plan.
fail to Prevent this problem ?
Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
 □ □
nt Representative

Date:

Sign & Date of MR

Doc. No:
Rev. No:
Rev. Date:

Auditor :

Department / Auditee Name : Inspection & Calibration

objective Evidences :

Refer complaint for wrong stud assembly-updated in FMEA no.10--occurence improved to 2 from 5
captured in process flow dia.PFD/MM/S201/250G related to change in M5 stud.
Treated as minor as this was one of case and process already implemented,removing risk to custo
Details of non-conformity : .
Process of development of Process flow diagram was not effective.

Requirement : 8.3.5.2

Proposed disposition :

Responcibility /Targate Date :

Attribution : Product Audit/ Process Audit /IATF/EMS/OHSAS Clause No: 8.5.1

Sign of Auditor :

Why Problem not detected ?

Why :

Why

Why

Why
Why

Root Cause :

Proposed Corrective action :

Responsibility/Targate Date :
Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Responsibility/Targate Date :

Date:

Verification of disposition :
Verification of Corrective action :

Verification of Preventive Action :

 Documents
Process Flow Diagram

PFMEA

Control Plan

Product Drawing

Inspection Report

Process Validation Report

Processing Sheet

Status of Horizontal Deployment :

Hence NCR is : Closed

Effeciveness Monitoring Remark by MR

Corrective action
 QMD-F-04
2
23.12.2019

ction & Calibration

embly-updated in FMEA no.10--occurence improved to 2 from 5. and Control plan-CP/MM/S201/250B.Work

M/S201/250G related to change in M5 stud.
case and process already implemented,removing risk to customer.

flow diagram was not effective.

8.3.5.2 Manufacturing process design output The organization shall document the manufacturing p
shall verify the outputs against manufacturing process design input requirements. The manufactur
characteristics for product and manufacturing process; c) identification of process input variables t
process(es); e) manufacturing process flow chartsflayout, including linkage of product, process, an
Annex A); j) standard work and work instructions; k) process approval acceptance criteria; I) data f
n) methods of rapid detection, feedback, and correction of product/manufacturing process nonconf

Audit /IATF/EMS/OHSAS Clause No: 8.5.1

 Root Cause (Use Why-W
oblem not detected ?
Follow Up Audit (Verifi
 Documents Updation & V

Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
□ □

Hence NCR is : Closed / Not Closed

Effectiveness Monitoring (After 03 month
by MR

Corrective action is found to be : Effective/Not Effec

 NC REPORT

proved to 2 from 5. and Control plan-CP/MM/S201/250B.Work instructions modified accordingly. Pending ac

oving risk to customer.

gn output The organization shall document the manufacturing process design output in a manner that enable
ufacturing process design input requirements. The manufacturing process design output shall include but is
ufacturing process; c) identification of process input variables that impact characteristics; d) tooling and equi
ess flow chartsflayout, including linkage of product, process, and tooling; f) capacity analysis; g) manufactur
k instructions; k) process approval acceptance criteria; I) data for quality, reliability, maintainability, and mea
back, and correction of product/manufacturing process nonconformities.
 Root Cause (Use Why-Why Analysis) :
Why did the Problem occure?
Why

Why

Why

Why :
Why

Root Cause :

Proposed Corrective action :

Responsibility/Targate Date :
Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Responsibility/Targate Date :

Follow Up Audit (Verification for Implementation):

 Documents Updation & Verification

Documents
Packaging Sign Off

Jig/ Fixture Drawings

BOM

Approved Supplier List

Training Records

Lession Learn (TGW/TGR)

Preventive Maintenance Checksheet

R is : Closed / Not Closed

Effectiveness Monitoring (After 03 month & Next consecutive audit)

rective action is found to be : Effective/Not Effective

 NC REPORT

S201/250B.Work instructions modified accordingly. Pending action for Cushion reviewed in FMEA review.Ho

e manufacturing process design output in a manner that enables verification against the manufacturing proce
The manufacturing process design output shall include but is not limited to the following: a) specifications a
input variables that impact characteristics; d) tooling and equipment for production and control, including ca
duct, process, and tooling; f) capacity analysis; g) manufacturing process FMEA; h) maintenance plans and
e criteria; I) data for quality, reliability, maintainability, and measurability; m) results of error-proofing identifica
process nonconformities.

Horizontal Deployement of disposition :

Responcibility /Targate Date :

Use Why-Why Analysis) :
the Problem occure?
w Up Audit (Verification for Implementation):
nts Updation & Verification

Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
□ □
Verification of NCR Status by Management Representativ

(After 03 month & Next consecutive audit)

tive/Not Effective
 Page

ngly. Pending action for Cushion reviewed in FMEA review.However change of location not

anner that enables verification against the manufacturing process design inputs. The organization
all include but is not limited to the following: a) specifications and drawings; b) special
tooling and equipment for production and control, including capability studies of equipment and
s; g) manufacturing process FMEA; h) maintenance plans and instructions; i) control plan (see
nability, and measurability; m) results of error-proofing identification and verification, as appropriate;

on :
 Why did system fail to Prevent this problem ?
Why

Why

Why

Why
Why

Root Cause :

Proposed Corrective action :

Responsibility/Targate Date :
Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Responsibility/Targate Date :
 Documents
Incoming Material Control Plan

Final Insp.Checkpoints

Firewall Insp.Checkpoints

SOP

Startup/Setup Checklist

Supplier PSW
Other Documents if any

Verification of NCR Status by Management Representative

Sign of Auditor:
 1 OF 2

NCR No. :01

Date : 10.01.2020

FMEA review.However change of location not

nufacturing process design inputs. The organization

) specifications and drawings; b) special
ntrol, including capability studies of equipment and
enance plans and instructions; i) control plan (see
proofing identification and verification, as appropriate;
fail to Prevent this problem ?
 Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
□ □
nt Representative

Date:

Sign & Date of MR

Doc. No:
Rev. No:
Rev. Date:

Auditor :

Department / Auditee Name : Inspection & Calibration

objective Evidences :

Refer Attribute study for scratch mark--3 appraisers and 50 parts-Kappa value-100,98,100--Miss ra
Treated as minor as other reports checked and miss rate and false alarm found adequate,knowled

Details of non-conformity : .
MSA process was not effective.

Requirement : 7.1.5.1.1

Proposed disposition :

Responcibility /Targate Date :

Attribution : Product Audit/ Process Audit /IATF/EMS/OHSAS Clause No: 8.5.1

Sign of Auditor :
 Why Problem not detected ?
Why :

Why

Why

Why
Why

Root Cause :

Proposed Corrective action :

Responsibility/Targate Date :
Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Responsibility/Targate Date :

Date:

Verification of disposition :
Verification of Corrective action :

Verification of Preventive Action :

 Documents
Process Flow Diagram

PFMEA

Control Plan

Product Drawing

Inspection Report

Process Validation Report

Processing Sheet

Status of Horizontal Deployment :

Hence NCR is : Closed

Effeciveness Monitoring Remark by MR

Corrective action
 QMD-F-04
2
23.12.2019

ction & Calibration

rk--3 appraisers and 50 parts-Kappa value-100,98,100--Miss rate is showing 16.7.No action evident.
hecked and miss rate and false alarm found adequate,knowledge for MSA was found adequate with concern

7.1.5.1.1 Measurement systems analysis Statistical studies shall be conducted to analyse the vari
The analytical methods and acceptance criteria used shall conform to those in reference manuals
Records of customer acceptance of alternative methods shall be retained along with results from a
special product or process characteristics.

Audit /IATF/EMS/OHSAS Clause No: 8.5.1

 Root Cause (Use Why-W
oblem not detected ?
Follow Up Audit (Verifi
 Documents Updation & V

Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
□ □

Hence NCR is : Closed / Not Closed

Effectiveness Monitoring (After 03 month
by MR

Corrective action is found to be : Effective/Not Effec

 NC REPORT

0,98,100--Miss rate is showing 16.7.No action evident.

dequate,knowledge for MSA was found adequate with concerned auditee.

alysis Statistical studies shall be conducted to analyse the variation present in the results of each type of ins
ance criteria used shall conform to those in reference manuals on measurement systems analysis. Other ana
alternative methods shall be retained along with results from alternative measurement systems analysis (se
ristics.
 Root Cause (Use Why-Why Analysis) :
Why did the Problem occure?
Why

Why

Why

Why :
Why

Root Cause :

Proposed Corrective action :

Responsibility/Targate Date :
Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Responsibility/Targate Date :

Follow Up Audit (Verification for Implementation):

 Documents Updation & Verification

Documents
Packaging Sign Off

Jig/ Fixture Drawings

BOM

Approved Supplier List

Training Records

Lession Learn (TGW/TGR)

Preventive Maintenance Checksheet

R is : Closed / Not Closed

Effectiveness Monitoring (After 03 month & Next consecutive audit)

rective action is found to be : Effective/Not Effective

 NC REPORT

n evident.
uate with concerned auditee.

analyse the variation present in the results of each type of inspection, measurement, and test equipment sy
erence manuals on measurement systems analysis. Other analytical methods and acceptance criteria may
with results from alternative measurement systems analysis (see Section 9.1.1.1). NOTE Prioritization of MS

Horizontal Deployement of disposition :

Responcibility /Targate Date :

Use Why-Why Analysis) :
the Problem occure?
w Up Audit (Verification for Implementation):
nts Updation & Verification

Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
□ □
Verification of NCR Status by Management Representativ

(After 03 month & Next consecutive audit)

tive/Not Effective
 Page

each type of inspection, measurement, and test equipment system identified in the control plan.
nalysis. Other analytical methods and acceptance criteria may be used if approved by the customer.
ems analysis (see Section 9.1.1.1). NOTE Prioritization of MSA studies should focus on critical or

on :
 Why did system fail to Prevent this problem ?
Why

Why

Why

Why
Why

Root Cause :

Proposed Corrective action :

Responsibility/Targate Date :
Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Responsibility/Targate Date :
 Documents
Incoming Material Control Plan

Final Insp.Checkpoints

Firewall Insp.Checkpoints

SOP

Startup/Setup Checklist

Supplier PSW
Other Documents if any

Verification of NCR Status by Management Representative

Sign of Auditor:
 1 OF 2

NCR No. :01

Date : 10.01.2020

est equipment system identified in the control plan.

nce criteria may be used if approved by the customer.
oritization of MSA studies should focus on critical or
fail to Prevent this problem ?
 Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
□ □
nt Representative

Date:

Sign & Date of MR

Doc. No:
Rev. No:
Rev. Date:

Auditor :

Department / Auditee Name : Inspection & Calibration

objective Evidences :

Refer torque tester-Torque tester-Sr No.15105217--calibrated according to DIN standard.DIN ISO

Treated as minor as overall calibration system is not impacted,checked calibration records for Torq

Details of non-conformity : .
Calibration process was not effective.

Requirement : 7.1.5.2.1

Proposed disposition :
Proposed disposition :

Responcibility /Targate Date :

Attribution : Product Audit/ Process Audit /IATF/EMS/OHSAS Clause No: 8.5.1

Sign of Auditor :

Why Problem not detected ?

Why :

Why
Why

Why

Why

Root Cause :
Proposed Corrective action :

Responsibility/Targate Date :

Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Proposed Preventive Action :

Responsibility/Targate Date :

Date:

Verification of disposition :

Verification of Corrective action :

□

Verification of Preventive Action :

Documents
Process Flow Diagram

PFMEA

Control Plan

Product Drawing

Inspection Report

Process Validation Report

Processing Sheet

Status of Horizontal Deployment :

Hence NCR is : Closed

Effeciveness Monitoring Remark by MR

Corrective action
 QMD-F-04
2
23.12.2019

ction & Calibration

No.15105217--calibrated according to DIN standard.DIN ISO 6789.Calibration on 10.04.17.Range 0.6-1.5 N

on system is not impacted,checked calibration records for Torque wrench,vernier,pressure gages,found with

e.

7.1.5.2.1 Calibration/verification records The organization shall have a documented process for ma
equipment (including employee-owned equipment relevant for measuring, customer-owned equipm
regulatory requirements, and customer-defined requirements shall be retained. The organization s
changes that impact measurement systems; b) any out-of-specification readings as received for ca
condition: d) when a piece of inspection measurement and test equipment is found to be out of cal
previous measurement results obtained with this piece of inspection measurement and test equipm
notification to the customer if suspect product or material has been shipped; f) statements of confo
as specified; h) records of the calibration and maintenance activities for all gauging (including emp
verification used for product and process control (including software installed on employee-owned
Audit /IATF/EMS/OHSAS Clause No: 8.5.1

Root Cause (Use Why-W

oblem not detected ?
Follow Up Audit (Verifi
 Documents Updation & V

Updation Verification

□ □
□ □
□ □
□ □
□ □
□ □
 □ □

Hence NCR is : Closed / Not Closed

Effectiveness Monitoring (After 03 month
by MR

Corrective action is found to be : Effective/Not Effec

 NC REPORT

andard.DIN ISO 6789.Calibration on 10.04.17.Range 0.6-1.5 Nm,no clarity about calibration frequency,not c
n records for Torque wrench,vernier,pressure gages,found with adequate calibration records and traceability

ords The organization shall have a documented process for managing calibration/verific.ation records. Reco
ned equipment relevant for measuring, customer-owned equipment, or on-site supplier- owned equipment) n
mer-defined requirements shall be retained. The organization shall ensure that calibration/verification activitie
systems; b) any out-of-specification readings as received for calibration/verification; c) an assessment of the
tion measurement and test equipment is found to be out of calibration or defective during its planned verifica
ned with this piece of inspection measurement and test equipment shall be retained, including the associate
ct product or material has been shipped; f) statements of conformity to specification after calibration/verificat
ation and maintenance activities for all gauging (including employee-owned equipment, customer-owned eq
cess control (including software installed on employee-owned equipment. customer-owned equipment, or o
 Root Cause (Use Why-Why Analysis) :
Why did the Problem occure?
Why

Why
Why

Why :

Why

Root Cause :
Proposed Corrective action :

Responsibility/Targate Date :

Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Proposed Preventive Action :

Responsibility/Targate Date :

Follow Up Audit (Verification for Implementation):

 Documents Updation & Verification

Documents
Packaging Sign Off

Jig/ Fixture Drawings

BOM

Approved Supplier List

Training Records

Lession Learn (TGW/TGR)

 Preventive Maintenance Checksheet

R is : Closed / Not Closed

Effectiveness Monitoring (After 03 month & Next consecutive audit)

rective action is found to be : Effective/Not Effective

 NC REPORT

7.Range 0.6-1.5 Nm,no clarity about calibration frequency,not captured in calibration list.
gages,found with adequate calibration records and traceability.

ed process for managing calibration/verific.ation records. Records of the calibration/verification activity for all
mer-owned equipment, or on-site supplier- owned equipment) needed to provide evidence of conformity to in
he organization shall ensure that calibration/verification activities and records shall include the following deta
as received for calibration/verification; c) an assessment of the risk of the intended use of the product cause
d to be out of calibration or defective during its planned verification or calibration or during its use, documen
nt and test equipment shall be retained, including the associated standard's last calibration date and the nex
tements of conformity to specification after calibration/verification; g) verification that the software version us
g (including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipmen
employee-owned equipment. customer-owned equipment, or on-site supplier-owned equipment).

Horizontal Deployement of disposition :

 Horizontal Deployement of disposition :

Responcibility /Targate Date :

Use Why-Why Analysis) :

the Problem occure?
w Up Audit (Verification for Implementation):
nts Updation & Verification

Updation Verification

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 □ □
Verification of NCR Status by Management Representativ

(After 03 month & Next consecutive audit)

tive/Not Effective
 Page

n frequency,not captured in calibration list.

s and traceability.

on records. Records of the calibration/verification activity for all gauges and measuring and test
ned equipment) needed to provide evidence of conformity to internal requirements, legislative and
erification activities and records shall include the following details: a) revisions following engineering
ssessment of the risk of the intended use of the product caused by the out-of-specification
s planned verification or calibration or during its use, documented information on the validity of
ing the associated standard's last calibration date and the next due date on the calibration report; e)
libration/verification; g) verification that the software version used for product and process control is
tomer-owned equipment, or on-site supplier-owned equipment); i) production-related software
equipment, or on-site supplier-owned equipment).

on :
on :

Why did system fail to Prevent this problem ?

Why

Why
Why

Why

Why

Root Cause :
Proposed Corrective action :

Responsibility/Targate Date :

Proposed Horizontal Deployment :

Responsibility/Targate Date :

Proposed Preventive Action :

Proposed Preventive Action :

Responsibility/Targate Date :
 Documents
Incoming Material Control Plan

Final Insp.Checkpoints

Firewall Insp.Checkpoints

SOP

Startup/Setup Checklist

Supplier PSW
 Other Documents if any

Verification of NCR Status by Management Representative

Sign of Auditor:
 1 OF 2

NCR No. :01

Date : 10.01.2020

ion activity for all gauges and measuring and test

of conformity to internal requirements, legislative and
he following details: a) revisions following engineering
he product caused by the out-of-specification
ts use, documented information on the validity of
date and the next due date on the calibration report; e)
ftware version used for product and process control is
owned equipment); i) production-related software
ment).
fail to Prevent this problem ?
Updation Verification

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nt Representative

Date:

Sign & Date of MR

 Abhijeet Technoplast India Pvt. Ltd, Nashik.
PROGRESS CONTROL LIST FOR NC (NC MONITORING SHEET) -IATF Follow Up Audit

Follow Up Audit (NCR Verification of Horizontal Deployement

IATF 16949 Major/M REPETATIVE NCR issued on NCR Submission Disposition Action (A+2 Days) Horizontal Deployement Preventive Action Verification of Corrective Action
Month SR. NO. NC Raised on Dept Name Auditee Auditor NC details (A+4days) ( A+7 days) for external Corrective Action (A+30 days) (A+30 Days) (A+60 Days) Verification) Horizontal Deployement Verification of Disposition action Action Verification of Preventive Action
clause inor ( YES/NO ) (A) (A+31 days) Root Cause Disposition Action Corrective Action

Plan Actual Plan Actual Plan Actual Plan Actual Plan Actual Plan Actual Plan Actual

Verified Quality requirement defined by SEDEMAC for yearly

Ravindra testing for Raw material for material identification, whereas no No mechanism available to trigger out addressing Customer Specific Raw Material testing plan updated by adding the Raw material & test has Annual CSR Review plan prepared including all All customer consider in Verified the Third Party Test report for Verified Annual CSR Review Plan
1 07.02.2019 QA AW, SJ 4.3.2 Minor No 10.02.2019 11.02.2019 15.02.2019 NA
Pagar material testing report evident for current year & available for last Requirement for new customer. carried out as per requirement. customer. CSR Review plan. raw material. 2019-20.
year.

Verified process change for Tailgate Garnish, not evident for Mold shifting to Mumbai only for trial purpose as per customer Change management to be initiate for every Verified the change management for Verified the outsource mold and change
2 07.02.2019 NPD Jitendra Mali RS, AW 8.5.6 Minor No 10.02.2019 11.02.2019 15.02.2019 Change management initiated for location change. Considering all molds. NA
molding. guideline. location change including trial. Tailgate Garnish. management initiated.

Ganesh Verified training record for Nov.18. Dec. 18 & Jan. 19, not evident Verified the training calender for the
3 08.02.2019 HRD RS, JM 7.2.2 Minor No 10.02.2019 11.02.2019 15.02.2019 Training not done as per scheduled in Jan. 2019. Training re-arranged in next month & completed. Agenda add in QRM ppt for HR Dept. …… Verified the QRM ppt for HR Dept. NA
Gaikwad for Jan. 19. month of March 2019.

Ganesh Verified the 5S audit score for Jan. 19. Audit not conducted for Jan. New 5S zones are identified and task assigned to Verified the 5S zones member and zone
4 08.02.2019 HRD RS, JM 7.1.4 Minor No 10.02.2019 11.02.2019 15.02.2019 Due to new construction 5S zone are changed. New 5S zones are identified and audit is completed. …… Verified the new identified 5S zones. NA
Gaikwad 19. zone leader. leader list.
Feb-19

Verified the stock of Raw material, MS C20 I Light Gray - RM 142 ERP SWAN system updated for returing the Verified the material ruturn note for MSC Verified the warehouse stock at store
5 08.02.2019 STR SS, NB Sagar Manzil 8.5.2 Minor No 10.02.2019 11.02.2019 15.02.2019 No provision for returing the material to store in SWAN system. Material return note filled up for returing the material to store. …… NA
stock observed physical 1050 Kg & in SWAN 905 Kg. material through SWAN to store warehouse. 20 I. and found updated.

Verified the critical spare part list & found available but actual parts
Critical Spare part list updated for considering the lead time for ordering Criteria point add by considering the lead time Verified the criteria defined in Crtical
6 07.02.2019 MNT Arun Pawar RP, PB 8.5.1.5 Minor not available as per list. Also no requirement given to PSD for No 10.02.2019 11.02.2019 15.02.2019 Parts are defined critical but available in market within a day. …… Verified the updated critical spare list. NA
above two days. above two days. Spare Part list.
same.

Verified that Internal Auditor and

Process of identifying criteria for maintaining auditor
Clause 7.2.3 requirement get understood and trainee auditor criteria is defined in
competency was not effective. -Documented process AGAQM-
accordingly system defined i.e core tool List cum competency of internal
P04 for Internal audit is not showing criteria identified for Internal
Shobha Yatin Criteria for internal audit defined for internal auditors considering IATF knowledge, CSR ,minimum audit conducted etc Verifief that Criteria for internal audit auditor,QMD-LS-02 (B),Rev-04 ,
1 14.02.2019 MR 7.2.3 Minor auditors.Shekhar Jadhav,Amol Waghmare. No 14.02.2019 15.03.2019 15.04.2019 Partial understanding of requirement of internal auditor competency …… NA
Shelar Gandhe requirements. evaluation checkpoints considered for internal defined 08/03/2019 and Internal Audit
Treated as minor as requirement knowledge was evident with
auditor competency. procedure AG-AQM-P-04,Rev-
process owner Organization has 5 Internal auditors and everybody
01,08.03.2019
has conducted 2 audits in 2018.

Problem solving process was not effective. - Refer complaint for

Foot rest bumper-Scorpio-poor aesthetic-RCA-Mat
weaviness.Loctite adhesive used for weaviness
defect.PFMEA/MM/W110/0990-weaviness already Verifed FMEA review checklist
PFMEA/MM/W110/0990 updated for
Shobha Yatin covered,However S,O,D values not mentioned after implementing No mechanism available to trigger out addressing of actions in PFMEA/MM/W110/0990 updated for severity ,Occurrence and detection FMEA review checklist to be defined to have defined to have trigger for
2 14.02.2019 QAD 10.2.3 Minor No 14.02.2019 15.03.2019 15.04.2019 …… severity ,Occurrence and detection for NA
Shelar Gandhe recommended action. FMEA for Loctite application trigger for addressing actions. addressing actions ,DOC . NO -
Loctite application
QAD-F-40,Rev-00,01.03.2019
Treated as minor as process already implemented and
recommended actions and S,O,D values checked for other failure
modes,found adequate

Process of conducting Manufacturing process audit was not

Verified that audit procedure for
effective. - Refer manufacturing process audit plan for Molding
manufacturing process audit is
process.Only first shift was covered and second shift planning and IATF manual reviewed for new requirement Process Audit Plan Modified for addition
Yatin New IATF requirement and partial awareness about the Process Audit Plan Modified for addition of second shift plan for audit modified for addition of all shift
3 14.02.2019 9.2.2.3 Minor evidence of shift hand over was not evident. No 14.02.2019 15.03.2019 15.04.2019 and thorough implementation of the clause …… of second shift plan for audit ,and audit NA
Gandhe Manufacturing process audit. ,and audit conducted accordingly. coverage and other IATF
requirement 9.2.2.3 done. conducted accordingly.
requirements,AG-AQM-P-04 -A
Treated as minor as this is the first year of implementation and
,dated 08.03.2019
requirement can be planned within next 2 years.

Servillaa Supplier QMS development process was not effective.- Refer

1.Verified Purchase order for B019
nce supplier list for supplier QMS status,Most of the suppliers are System defined for -
for BROS Plastics ,provision made in
Audit certified for ISO 9001:2015 and IATF 16949,however QMS status 1.Certification Due date on Purchase Order
SWAN for addressing IATF
was not clear for QMS for Autotech polymers,Ace which linked with Purchase Order
Prashant Yatin 1. Review Mechanism Or Prior trigger for Certification Due Date not Valid QMS certificate collected from certificate Due date and linkaged of it
4 14.02.2019 PSD 8.4.2.3 Minor Enterprises.Organization could not demonstrate compliance to No 14.02.2019 15.03.2019 15.04.2019 Valid QMS certificate collected from Basell ,Kingfa & Evonik 2.Certification Date & Due date availability on …… NA
Bagul Gandhe defined in system Basell ,Kingfa & Evonik with generation of PO
QMS status. Supplier score card which would be review
2.Verified Score Card for Grace
monthly.
Plast revised for addressing QMS
Treated as minor as supplier audit conducted for these suppliers
certification date & due date.
and QMS status checked during audit and found certfied.

System rectified for

Process of informing statutory and regulatory requirements to
1.Addition of Statutory & Regulatory
supplier was not effective. - Refer Mahindra std-Control of
requirement in Purchase Orders Verified Purchase Order
Hazardous Chemical substances-F-00-0387,which covers statutory Testing reports as per F-00-0387
Prashant Yatin Supplier verification for statutory and regulatory requirements & its Testing reports as per F-00-0387 collected from supplier and verified for 2.Statutory & Regulatory requirements POP/040004 for mentioning
5 14.02.2019 PSD 8.4.3.1 Minor and regulatory requirements.Though the standard was shared with No 14.02.2019 15.03.2019 15.04.2019 …… collected from supplier and verified for NA
Bagul Gandhe compliance not defined in System compliance with requirements verification at initial and process/product audits requirement of complience with
supplier,the compliance with the requirement was not evident. compliance with requirements
at supplier end. statutory & Regulatory requirements
treated as minor as supplier selection from covers the statutory and 3.Points added in CIR for suppliers
regulatory requirement point and checked during audit.

Process of capturing Overhaul of machines requirement was not

effective. - Refer Total productive maintenance
Verified Process Manual MTD
Yatin system.Overhauling plan for molding machines 1300 Tonne,800 System Defined i.e Process Manual modified for
6 14.02.2019 8.5.1.5 Minor No 14.02.2019 15.03.2019 15.04.2019 Overhaul was new concept and not defined in system Overhaul plan for 1300T & 800T made …… Overhaul plan for 1300T & 800T made -PRO/MNT/01 for adderessing NA
Gandhe Tonne was not added. addition of Overhaul requirement and issued
Overhaul maintainance system.
Treated as minor as actually for 800 Tonne is planned in March 19
and related work is in progress,no avbsence of system.

Set up approval process was not effective.- Refer set up approval

dated 14 Feb 19 for molding machine 1300 Tonne,Calendar
marking was showing January 19 ,still report was accepted. Verified Setup checklist MLD-F-04
Yatin Check point not available in set up change over check sheet in Check point of calendar addressed in set up
7 14.02.2019 MLD Rajesh Sahoo 8.5.1.3 Minor No 14.02.2019 15.03.2019 15.04.2019 Calender Punched for Feb-19 …… Calender Punched for Feb-19 for addition of checkpoint of NA
Gandhe molding change over check sheet.
Treated as minor as operator writes the date and shift on each part Calender punching verification.
which ensures manufacturing date and month.

Verified that Mock drill conducted for

Shobha While reviewing contigency plan,it is observed that periodic tests of Mock drill conducted for molding supplier -Mayuresh Industried for Verified that Mock drills of Contigency
1 8/26/2019 MLD Rajesh Sahoo 6.1.2.3 Major Yes 8/27/2019 8/27/2019 8/31/2019 9/1/2019 9/27/2019 10/10/2019 Mock drill of contigency not defined in system Mock drills of Contigency situation to be define NA molding supplier -Mayuresh NA
Shelar contigency plans are not evident Inhouse capacity situation to be define
Industried for Inhouse capacity
Verified that Supplier audit criteria
Supplier audit criteria to be define considering
Shekhar Shobha Supplier Audit report for Exotech Zanini ,pune not evident as per Defined Supplier audit frequency not suitable to follow for all verified that Self assesment done for defined considering ppm,delivery
2 8/27/2019 Purchase 8.4.2.4 Minor No 8/27/2019 8/27/2019 8/31/2019 9/1/2019 9/27/2019 10/10/2019 Self assesment done for Exotech Zanini ppm,delivery ,quality issues,customer approved NA NA
Jadhav Shelar supplier audit plan. suppliers Exotech Zanini ,quality issues,customer approved source
Aug-19 source etc.
etc.
statutory & regulatory
requirements to be identify Verified that statutory and regulatory Verified PO format modifed for
Shekhar Shobha Statutory & Regulatory requirements are not identified for Sairaj PO format which exist in system does not give trigger to consider PO format to be modify for adderessing
3 8/27/2019 Purchase 8.4.3 Minor No 8/27/2019 8/27/2019 8/31/2019 9/1/2019 9/27/2019 10/10/2019 statutory and regulatory requirements identified for Sairaj plastic while supplier evalution - requirements identified for Sairaj adderessing statutory & Regulatory NA
Jadhav Shelar Plastics,Ambad. statutory and regulatory requirements statutory & Regulatory requirements
accordingly format to be plastic requirements
modify