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NC Closure 5 Why Analysi

The document describes a nonconformity finding regarding the effectiveness of contingency plan testing. The IATF requirement for contingency plans includes provisions to test plans periodically and review them annually. The organization's contingency plan and risk analysis document did not have evidence that testing was conducted for interruptions from externally provided products. The corrective actions included conducting testing for this contingency and revising the contingency testing format to include interruptions from external suppliers.

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Karan Malhi
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100% found this document useful (3 votes)
5K views26 pages

NC Closure 5 Why Analysi

The document describes a nonconformity finding regarding the effectiveness of contingency plan testing. The IATF requirement for contingency plans includes provisions to test plans periodically and review them annually. The organization's contingency plan and risk analysis document did not have evidence that testing was conducted for interruptions from externally provided products. The corrective actions included conducting testing for this contingency and revising the contingency testing format to include interruptions from external suppliers.

Uploaded by

Karan Malhi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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Finding

IATF Requirement

NC Details
INCIDENT SPECIFIC
CORRECTIVE ACTION
(What is done to solve this
problem)

Why Why Analysis

Why 1

Why 2

Why 3

Why 4

Why 5

Root Cause

Correction

Systemic Corrective Action

Documented Evidence
The process of identifying & documenting the special characteristics is not effective.

The organization shall use a multidisciplinary approach to establish,


document, and implement its process(es) to identify special
characteristics, including those determined by the customer and the
risk analysis performed by the organization, and shall include the
following:
a) documentation of all special characteristics in the drawings (as
required), risk analysis (such as FMEA), control plans, and standard
work/operator instructions; special characteristics are identified with
specific markings and are cascaded through each of these
documents;
b) development of control and monitoring strategies for special
characteristics of products and production processes;
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or the
organization’s equivalent symbols or notations, as defined in a symbol
conversion table. The symbol conversion table shall be submitted to
the customer, if required.

Refer Drawing No: 10329393, Rev.02 for Model: K ZS11 Brake line for MG Motors. Also Refer FMEA /ATO/009, REV,06, & Control
plan: CPO/
ATO/022 , REV.02, for the same.
As per drawing, material shall conform to automotive prohibition of hazardous substances and meet specifications: SMTC 5 500 001.
However
this regulatory characteristic, not identified in the PFMEA & Control Plan.
The process of identifying & documenting the special characteristics is not effective.

Identification of special characteristics Regarding Hazardous Substances not added in the format.

Format for capturing the Design Input is not reviewed and updated for the requirement of Standard IATF 16949:2016

Training for requirement of IATF 16949:2016 not given to the concerned person - Mr.Pravin Chovatiya

Due to lack of requirements of IATF 16949:2016 to the concerned person, the format was not reviewed and updated for the
requirements of IATF16949:2016.

The Design Input Capture Form - FRM/ENGG/DICF Rev 0 dated 06.10.2017 was reviewed and updated with revision change for the
requirement of standard IATF 16949:2016

Design Input Format Revised with including all design input requirement as per IATF 16949:2016
Training Provide to Mr.Pravin Chovatiya for IATF 16949:2016 and

1) Design Input Capture Form - FRM/ENGG/DICF - Rev 0 dated 06.10.2017


2) Design Input & Output Capture Form - FRM/ENGG/DIOCF - Rev 01 dated 04.06.2018
3) Training Certificate - IATF 16949:2016 for Mr.Pravin Chovatiya
Finding

IATF Requirement

NC Details

INCIDENT SPECIFIC
CORRECTIVE ACTION
(What is done to solve this
problem)

Why Why Analysis

Why 1

Why 2

Why 3

Why 4
Why 5

Root Cause

Correction

Systemic Corrective Action

Documented Evidence
Process of Layout Inspection is not effective.Process of Layout Inspection is not effective.

A layout inspection and a functional verification to applicable


customer engineering material and performance standards shall be
performed for each product as specified in the control plans. Results
shall be available for customer review.

Refer Layout inspection report, dated 03-03-21 for TML part no. 542542800121: pipe Assly. Brake. Pipe size: 4.75 mm OD
x 0.7 mm thickness &
marking 20 mm away from coupling nut & width 20 mm, as mentioned in the drawing not found checked during layout
inspection.

Layout Inspection done for TML part no. 542542800121 with considering all drawing specification with including Notes also

Process of Layout Inspection is not effective.

All the drawing specification was not Included in Layout Report for TML part no. 542542800121

Format not included all the drawing specification

Drawing Notes not consider in report format


Drawing Notes not consider in report format

Layout Inspection done for TML part no. 542542800121 with considering all drawing specification with including Notes also

Layout Inspection Format revised with considering all drawing specification with including Notes also

1.Layout Report
2.Training Records
3.Drawing with Balooning
Finding

IATF Requirement

NC Details

INCIDENT SPECIFIC
CORRECTIVE ACTION
(What is done to solve this
problem)

Why Why Analysis

Why 1
Why 2

Why 3

Why 4

Why 5

Root Cause

Correction

Systemic Corrective Action

Documented Evidence
The process of internal audit planning is not effective.

The organization shall have a documented internal audit process. The


process shall include the development and implementation of an
internal audit programme that covers the entire quality management
system including quality management system audits, manufacturing
process audits, and product audits.
The audit programme shall be prioritized based upon risk, internal and
external performance trends, and criticality of the process(es).
Where the organization is responsible for software development, the
organization shall include software development capability
assessments in their internal audit programme.
The frequency of audits shall be reviewed and, where appropriate,
adjusted based on occurrence of process changes, internal and
external nonconformities, and/or customer complaints. The
effectiveness of the audit programme shall be reviewed as a part of
management review.

Product Audit annual plan verified for 2021. Frequency: Yearly .


product audit of SMG Part No: 51410M68P10, was conducted, in Jan.21 as per annual plan. In Feb.21 customer complaint
was received for the
same part, however after that frequency of product audit not increased for this part, and no extra product audit evident for
this part.

The process of internal audit planning is not effective.


Product audit not conducted after receiving complaints

Product Audit plan frequency not review after any Customer complaints

Internnal Audit Procedure not included for frequency increase when customer complaint received

Internnal Audit Procedure not included for frequency increase when customer complaint received

Internal Product Audit Done for SMG Part No: 51410M68P10

1.Internal Audit Procedure BIQAP 9.2 Rev. No. 03, Rev.Date 01.07.2021, Revised with included "Product Audit should be
done after receiving any customer complaints"

1.Product Audit Plan


2.Product Audit Report For SMG Part No: 51410M68P10
3.Revised Internal Audit Procedure BIQAP 9.2 Rev. No. 03, Rev.Date 01.07.2021
Finding
IATF Requirement

NC Details

INCIDENT SPECIFIC
CORRECTIVE ACTION
(What is done to solve this
problem)

Why Why Analysis

Why 1

Why 2

Why 3

Why 4

Why 5

Root Cause

Correction

Systemic Corrective Action

Documented Evidence
any of the following: key equipment failures (also see Section
8.5.6.1.1); interruption from externally provided products, processes,
and services; recurring natural disasters; fire; utility interruptions;
labour shortages; or infrastructure disruptions;
d) include, as a supplement to the contingency plans, a notification
process to the customer and other interested parties for the extent
and duration
Process of anyofsituation
of testing impacting
contingencies customer
is not operations;
effective.
e) periodically test the contingency plans for effectiveness (e.g.,
simulations, as appropriate);
f) conduct contingency plan reviews (at a minimum annually) using a
multidisciplinary
Refer Contingency team
Planincluding top management,
& Risk Analysis: and update
CF-06-ALL-1201, as B dated: 01-05-20. Testing of contingency for 'In
Rev.
required; provided products' not evident.
externally
g) document the contingency plans and retain documented
information describing any revision(s), including the person(s) who
authorized the change(s).
The contingency plans shall include provisions to validate that the
Contegency
manufactured Testing
productdone For Interruption
continues from externally
to meet customer provided products
specifications
after the re-start of production following an emergency in which
production was stopped and if the regular shutdown processes were
not followed.
Statement of nonconformity
Process of testing of contingencies is not effective.
Draft audit report
Organization nameof contingencies is not effective.
Process of testing

Interruption from externally provided products not tested for contigency

Format For Capturing the Contigency Testing Check sheet not included for contigency of Interruption from exter

Due to lack of awareness for the requirements of IATF 16949:2016 to the concerned person, the format was not
requirements of IATF16949:2016.

Due to lack of awareness for the requirements of IATF 16949:2016 to the concerned person, the format was not
requirements of IATF16949:2016.

Contegency Testing done For Interruption from externally provided products

Format for Capturing Contigency testing check sheet revised with including "Interruption from externally provide
other requirements of IATF16949:2016 for contigency

1.Contigency Testing Check sheet


2.Contigency Plan
ed products
Finding

IATF Requirement
NC Details
INCIDENT SPECIFIC
CORRECTIVE ACTION
(What is done to solve this
problem)

Why Why Analysis

Why 1

Why 2

Why 3

Why 4

Why 5

Root Cause

Correction

Systemic Corrective Action

Documented Evidence
The organization shall audit all manufacturing processes over each
three-year calendar period to determine their effectiveness and
efficiency using customer-specific required approaches for process
audits.
PlanningWhere not defined by
of manufacturing the customer,
process theeffective
audit is not organization shall
determine the approach to be used.
Refer manufacturing process audit: annual plan: 2020 & 2021. Coating is running in 3 shifts, however planning o
Within
processeach
auditindividual audit plan, each manufacturing process shall be
audited
of coating inallallshifts
on where
3 shifts not itdone.
occurs, including
Refer the appropriate
manufacturing process audit report dated: 05-05-21, 3rd shift for coating
sampling
shift of the shift handover.
The manufacturing
handover audit alsoprocess audit shall include an audit of the effective
not evident.
implementation of the process risk analysis (such as PFMEA), control
plan, and associated documents.

Manufacturing Process audit done for CPP with covering all 3 shifts with including sampling of shift handover

Planning of manufacturing process audit is not effective

Manufacturing process audit of coating (CPP) in all 3 shifts not done

Audit Schedule not reflect for covering all 3 shifts for Coating Process ( CPP)

Audit schedule only reflect the date and time of audit ,not reflect the shift

Audit schedule only reflect the date and time of audit ,not reflect the shift

Manufacturing Process audit done for CPP with covering all 3 shifts with including sampling of shift handover

Revised Audit schedule with mention date ,time period and shift
Revised Manufacturing Process Audit Check sheet with including "Shift handover activity"

1.Audit Reschedule Plan for CPP


2.Audit Schedule for CPP
3.Manufacturing Process audit Report for coating (CPP)
Finding
IATF Requirement
NC Details

INCIDENT SPECIFIC
CORRECTIVE ACTION
(What is done to solve this
problem)

Why Why Analysis

Why 1

Why 2

Why 3

Why 4

Why 5

Root Cause

Correction

Systemic Corrective Action

Documented Evidence
manufacturing process design output shall include but is not limited to
the following:
a) specifications and drawings;
b) special characteristics for product and manufacturing process;
c) identification of process input variables that impact characteristics;
d) tooling and equipment for production and control, including
The process
capability of manufacturing design out put with regard to FMEA is not effective.
During thestudies of equipment
manufacturing processandaudit
process(es);
FMEA, Doc. No. FMEA/PBW/01, Rev. 31, Date : 16/09/20 reviewed. Potent
e) manufacturing
verified for process flow charts/layout, including linkage of
product, process,
tube rolling process.and tooling;
f) capacityfailure
Potential analysis;
mode - Poor tube construction - Severity : 8, Occurrence : 6, Detection : 3, RPN : 192
g) manufacturing process
Potential failure mode FMEA;
- Voids / loose seam - Severity : 8, Occurrence : 7, Detection : 3, RPN : 168
h)
Nomaintenance plans and
any recommended instructions;
actions were identified. Further no any record available to demonstrate the type of actions to
i) control plan (see Annex A);
j) standard work and work instructions;
k) process approval acceptance criteria;
l) data for quality, reliability, maintainability, and measurability;
m) results of error-proofing identification and verification, as
appropriate;
n)
The methods
processofofrapid detection, design
manufacturing feedback,
outand correction
put with regardoftoproduct/
FMEA was not effective.
manufacturing process nonconformities.
Recommended action not mentioned against high RPN
Finding

IATF Requirement

NC Details

INCIDENT SPECIFIC
CORRECTIVE ACTION
(What is done to solve this
problem)

Why Why Analysis

Why 1

Why 2

Why 3

Why 4

Why 5

Root Cause

Correction

Systemic Corrective Action


Documented Evidence
The process of analysis and evaluation with regard to internal rejection is not effective.

(Enter ISO 9001:2015 requirement)


The organization shall analyze and evaluate appropriate data and
information arising from monitoring and measurement.
The results of analysis shall be used to evaluate:
a) conformity of products and services;
b) the degree of customer satisfaction;
c) the performance and effectiveness of the quality management
system;
d) if planning has been implemented effectively;
e) the effectiveness of actions taken to address risks and
opportunities;
f) the performance of external providers;
g) the need for improvements to the quality management system.
NOTE : Methods to analyze data can include statistical techniques.

The internal rejection target for Assembly (Rigid & Nylon) is <1000 PPM. However it have been observed beyond th
the month
of : Aug'20 : 4350 PPM, Oct : 3176 PPM, Dec : 2288 PPM, Jan'21 : 3897 PPM, Mar : 2838 PPM, Apr : 3127 PPM, M
Analysis and
evolution of data reviewed but analysis is not effective to meet the target level.

The process of analysis and evaluation with regard to internal rejection was not effective.

Last 5 month Internal PPM Target not achieved

Target not Achievable

Target setting strategy not on factual data of previous


Finding

IATF Requirement

NC Details

INCIDENT SPECIFIC
CORRECTIVE ACTION
(What is done to solve this
problem)

Why Why Analysis

Why 1

Why 2

Why 3

Why 4

Why 5

Root Cause

Correction

Systemic Corrective Action


Documented Evidence
The process of on-the-job training is not effective.

The organization shall provide on-the-job training (which shall include


customer requirements training) for personnel in any new or modified
responsibilities affecting conformity to quality requirements, internal
requirements, regulatory or legislative requirements; this shall include
contract or agency personnel. The level of detail required for on-the
job training shall be commensurate with the level of education the
personnel possess and the complexity of the task(s) they are required
to perform for their daily work. Persons whose work can affect quality
shall be informed about the consequences of nonconformity to
customer requirements.

Refer to Maintenance process, the skill matrix of maintenance technicians involved in preventive maintenance - mec
maintenance
verified for Mr. RJ Kharwa, Mr J Goasi and Mr KC Panchal. All these technicians have been graded with all 4 skills f
maintenance.
Further it was enquired for the skill wise training and evaluation record for Mr RJ Kharwa, which was not available.
Skill Evaluation done with level wise question Paper for Mr.RJ Kharwa

The process of on-the-job training is not effective.

Skill wise training and evaluation record not available.

Skill Evaluation done on the basis of behaviour,softs kill and hard skill as per observation & verbal questioning .

Skill Level wise question paper not Available

Skill Level wise question paper not Available

Skill Evaluation done with level wise question Paper for Mr.RJ Kharwa

Skill Evaluation done on the basis of result of Exam with Level wise question paper
1.Skill wise Training Records
2. Skill Evaluation Question Paper Level wise Records
3.Skill Matrix

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