SYSTEM AUDIT CHECKLIST

AS PER ISO/TS 16949:2009

Deptt.Name :-Store AUDITOR:- AUDITEE:-

Maximum 15 working days to close the NC after that:-

>> Inform to GM level on 20th working/days
>> Inform to MD on 25th working/days

Rating
NO. CLAUSE NO PROCESS REQUIREMENTS REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS
Required Actual
A) Is there is documented quality policy, quality objectives, manual & Procedure are available?
B) Is documented Procedures are fully establsihed, maintained & implemented?
(C) Location chart,List of shelf life items,Preservation method (controlled environment),Monitoring of condition of stored material, QA approval if
NG,Availability of Material Safety Data Sheet (MSDS),All the material details received from the suppliers are entered in the computer at the
1 4.2
Documentation gate.,The material is received in the Receipt stores along with the supplier documents after the gate entry. ,Availability of packing
Requirements standard,Inventory norms (Min & Max) part, Raw material ,Master List of Documents,Control of records with latest rev. no. 3

A) Is there any responsibilities & authorities defined or well communicated within the organization by the top management ?
2 5.5.1
Responsibilty &
Authority B) Are the roles and responsibility & control item of the usual operation/ abnormal situation (when and what should be made?) 3
defined for each manager and supervisor?

A) Does any type of comptence level is sets by an organization for all the personnel performing in the organization?
B) Is there is any Training procedure for improving the competency of personnel from minimum to maximum is available or not?
C) Do you make the education plan for employees (by class, specialty , external or contractual , beginner)?,Do you implement the
Competence, education as planned and keep the records?,Is education given to managers and supervisors?,Do you record the educational
3 6.2.2 training &
awareness
history of each individual?,Do you make skill sheet (Matrix) of each individual? 3

A) Does the production plan satisfy or fulfill the customer requirement or not?,
4 7.5.1.6
Production
Scheduling
B) Quantity - Difference between documented & physical stocks ,Condition of the stored materials - Details of damaged, lost, expired
materials,
3

A) Is there any identification & traceability system available for control over the product?
B)Location identification for material storsge, temporary location,Material identification with min & max levels,Material Storage as per
FIFO,Receiving of rejected material from deptt with proper identification,Material ID tag - Part name, No, Qty, Mfg dt,Mixing Avoiding
System,Is the Initial product tag attached on the product from the changed process, and is the identification of Initial product supply
5 7.5.3
Identification & controlled throughout the vendor processes (including Sub-vendors)?,Do you ensure first-in-first-out precisely with the parts tag or lot
Traceability display etc.,Do you specify the part number , quantity, manufacturing date etc. on the material, stocks, extra product& spare parts
3
etc.

A) Is there any kind of customer satisfaction survey conducts by which the organisation measure the customer satisfaction index?.
B)FIFO record,Material identification with min & max levels,Rejection sned back to vendor record,Mixing Avoiding System,Is the
Initial product tag attached on the product from the changed process, and is the identification of Initial product supply controlled
6 8.2.1
Customer
Satisfaction throughout the vendor processes (including Sub-vendors)?, 3

A) Is there any evaluation of their QMS system done by the organisation for continual improvement?

B) Does the data analysis is done with respect to the factors like customer satisfaction, conformity to product requirement, preventive
action result & its effectiveness & suppliers quality?Do you ensure first-in-first-out precisely with the parts tag or lot display etc.,Do
you specify the part number , quantity, manufacturing date etc. on the material, stocks, extra product& spare parts etc.
7 8.4 Analysis of Data 3
C) Conformation , Evaluation & Verification of department wise target By top Management.

A) Does the organization continually improves the effectiveness of QMS system with the help of quality policy, objectives, audit
results, analysis of data,corrective & preventive action & management review?
B) Do you decide the yearly quality target of company and each department and follow up the actual results numerically (money loss
for defect ,number of cases and defect rate etc.)Do you keep records of the results and follow-up the defect items.,Are the roles
8 8.5.1
Continual
Improvement
and responsibility & control item of the usual operation/ abnormal situation (when and what should be made?) defined for each
manager and supervisor?
3

IQA Criteria:- "0" :- Plan ,Record & Awareness not evident . "1" :- Plan ,WI ,Record & Awareness Available But Record not maintained . "3" :- All PDCA Available & Maintained.
>> Minimum Requirment to Prevent Re-audit is 80 % .
F-SYS-04-04
AUDITEE:- DATE:-

ROOT CAUSE ANALYSIS ACTION TAKEN RESP. PERSON / DATE

 SYSTEM AUDIT CHECKLIST
AS PER IATF 16949:2016

LEAD AUDITOR:- AUDITOR:- AUDITEE:- DATE:-

Maximum 15 working days to close the NC after that:-

>> Inform to GM level on 20th working/days
>> Inform to MD on 25th working/days

Rating
CLAUSE
NO. PROCESS REQUIREMENTS CHECK POINTS REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS
NO
RESP. PERSON /
Required Actual ACTION TAKEN
DATE
4. Context Of Organisation

NOTE 1 Understanding the external context can be facilitated by

Understanding the The organization shall determine external and internal issues that are
1 4.1 Organisation and relevant to its purpose and its strategic direction and that affect its ability
its Context to achieve the intended result(s) of its quality management system.
considering issues arising from legal, technological, competitive, market,
cultural, social, and economic environments, whether international,
national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by
considering issues related to values, culture knowledge and performance 3
of the organization.
i)Has JNS determined external and internal issues relevant to its purpose
and strategic direction?
ii)Do these Issues affect the ability to achieve the intended result of the
QMS?

Has JNS conducted a study to determine the impact or potential impact on

the organization’s ability to consistently provide products and services that
I) Has Best Bars determined what requirements those parties have that
meet customer and applicable statutory and regulatory requirements, the
Understanding the are relevant to the QMS?
organization shall determine:
needs and II)Has Best Bars determined the impact or potential impact?The
2 4.2 a) The interested parties that are relevant to the quality management
expectations of III)organization shall monitor and review the information about these
system;
interested parties interested parties and their relevant requirements.
b) The requirements of these interested parties that are relevant to the
quality management system.

Determining the
scope of the
The organization shall determine the boundaries and applicability of the
quality I) Has Best Bars set the boundaries and applicability of the QMS been
3 4.3 quality management system to establish its scope.
management used to establish the scope of the organization?
system

Supporting functions, whether of site or remote (Such as design centers,

corporate headquarters and distributions centers) shall be included in the
scope of the QMS.
The only permitted exclusion permitted for the Automotive QMS standard
Determining the
4 4.3.1 relates to the production design and development requirements within ISO
scope of the QMS
9001:2015, Section 8.3. The exclusion shall be justified and maintain as
documented information (See ISO 9001, Section 7.5_)
Permitted exclusions do not include manufacturing process design.

Customer Specific Customer specific requirements shall be evaluated and included in the Is the customers specific requirements included in the scope of Best Bars
5 4.3.2
Requirements scope of the Organisations QMS QMS?

The organization shall determine the processes needed for the quality
management system and their application throughout the organization and
shall determine:
a) the inputs required and the outputs expected from these processes;
b) the sequence and interaction of these processes;
I) The organization shall establish, implement, maintain and continually c) the criteria, methods, including measurements and related performance
improve a quality management system, including the processes needed indicators needed to ensure the effective operation, and control of these
and their interactions, in accordance with the requirements of this processes;
Quality
International Standard. d) the resources needed and ensure their availability;
management
6 4.4.1 II) The organization shall maintain documented information to the extent e) the assignment of the responsibilities and authorities for these
system and its
necessary to support the operation of processes and retain documented processes;
processes
information to the extent necessary to have confidence that the processes f) the risks and opportunities in accordance with the requirements of 6.1,
are being carried out as planned. and plan and implement the appropriate actions to address them;
g) the methods for monitoring, measuring, as appropriate, and evaluation
of processes and, if needed, the changes to processes to ensure that they
achieve intended results;
h) opportunities for improvement of the processes and the quality
management system.

Conformance of The organisation shall ensure conformance of all products and processes,
Does Best Bars conduct a risk assessment in terms of all the Statutory
7 4.4.1.1 products and including service parts and those that are outsourced, to all applicable
and regulatory requirements?
processes customers, statutory requirements (See Sections 8.4.2.2)

I) Does Best Bars identify the organisational statutory and regulatory

The organisation shall have documented processes for the Management
of Product Safety related products and manufacturing processes which
8 4.4.1.2 Product Safety
shall include but not limited to the following, where applicable:
product safety requirements?
II) Reaction plans? (See Section 9.1.1.1)
III) Identification of product safety related characteristics?
IV)Training identified by Best Bars or customer for personnel involved in
product safety related products and associated manufacturing processes?
V) Product trace-ability by manufactured lot (At a minimum) throughout the
supply chain (See section 8.5.2.1
 CLAUSE
NO. PROCESS REQUIREMENTS CHECK POINTS REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS
NO
RESP. PERSON /
Required Actual ACTION TAKEN
DATE

9 4.4.2
 CLAUSE
NO. PROCESS REQUIREMENTS CHECK POINTS REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS
NO
RESP. PERSON /
Required Actual ACTION TAKEN
DATE
 CLAUSE
NO. PROCESS REQUIREMENTS CHECK POINTS REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS
NO
RESP. PERSON /
Required Actual ACTION TAKEN
DATE
 CLAUSE
NO. PROCESS REQUIREMENTS CHECK POINTS REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS
NO
RESP. PERSON /
Required Actual ACTION TAKEN
DATE
 CLAUSE
NO. PROCESS REQUIREMENTS CHECK POINTS REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS
NO
RESP. PERSON /
Required Actual ACTION TAKEN
DATE

F-SYS-04-04
 SYSTEM AUDIT CHECKLIST
AS PER IATF 16949:2016

LEAD AUDITOR:- AUDITOR:- AUDITEE:- DATE:-

Maximum 15 working days to close the NC after that:-

>> Inform to GM level on 20th working/days
>> Inform to MD on 25th working/days

Rating
REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS

CLAUSE RESP. PERSON /

NO. PROCESS REQUIREMENTS CHECK POINTS Required Actual ACTION TAKEN
NO DATE
4. Context Of Organisation

Understanding the The organization shall determine external and internal issues that are
1 4.1 Organisation and relevant to its purpose and its strategic direction and that affect its ability 3
its Context to achieve the intended result(s) of its quality management system.

Quality
A) Is there proper control over the outsourced processes done for
2 4.1.1 Management 3
completing the product is monitored or not?
System

A) Is there is documented quality policy, quality objectives, manual &

Procedure are available?
Documentation
3 4.2 3
Requirements
B) Is documented Procedures are fully establsihed, maintained &
implemented?
A) Is Quality Management System includes the scope of the QMS
including details & justification for any exclusion?
4 4.2.2 Quality Manual 3
B) Is there is linkage or reference of documented procedures is available
in Quality manual?

A) Is all documents are in controlled manner?

B) Revision on each document is clearly visible.

C) Retention period list available or not?

Control of
5 4.2.3 3
Documents
D) Obsolete document record & revision history sheet maintained or not?

E) Is there any method developed by the organization by which latest

revised documents are properly informed or distribute to all concerned
departments?

A) Records of Engineering specification change are available or not?

Engineering
6 4.2.3.1 B) List of documents updated against the change. 3
Specification
C) Is the change implemented within the 2 Weeks or not?

A) Is there is any documented procedure is available for document &

record control?
Control of
7 4.2.4 3
Records
B) Document & record Identification, storage, protection, retrieval,
retention & disposition method is available or not?

Records A) Is the decided retention period fulfill the statutory, regulatory &
8 4.2.4.1 3
Retention Customer Requirements?

5. MANAGEMENT RESPONSIBILITY

Management A) Is there is any documented procedure is available to check timely

9 5.1 3
Commiment review of quality policy, objectives & resources?

A) Review records by top management about the product realization

10 5.1.1 Process Efficiency processes & the support processes regarding their effectiveness & 3
efficiency are available or not?

A) Is all the requirements demands by the customers are effectively

11 5.2 Customer Focus 3
monitored or fullfilled?

A) Is the Quality policy sets by the top management contains the purpose
of organization, commitment to comply & continual improve the QMS?
12 5.3 Quality Policy 3
B) Is the Quality policy communicated & understood by all bodies present
in an organization?

A) Are the objectives decided by the top management are measurable &
contains the relevant targets to met the customer requirements?
13 5.4.1 Quality Objectives 3

B) Are the decided objectives reflects the Quality Policy or not?

Quality Objectives
14 5.4.1.1 A) Is all the objectives includes in company business plan or not 3
Supplemental

A) Is QMS designed by the top management contains all the requirements

Quality of customer?
15 5.4.2 Management 3
System Planning B) Are the objectives also planned as per the customer requirements for
fully satisfaction by the customer?

Responsibilty & A) Is there any responsibilities & authorities defined or well communicated
16 5.5.1 3
Authority within the organization by the top management ?

Responsibilty for A) Is Shiftwise Quality person are available for ensuring the confirmation
17 5.5.1.1 3
Quality of quality of the product?
 REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS

CLAUSE RESP. PERSON /

NO. PROCESS REQUIREMENTS CHECK POINTS Required Actual ACTION TAKEN
NO DATE

Management A) Is the top management appoints the management representative for

18 5.5.2 3
Representative reporting or communicating the performance of QMS?

Customer A) Is there is any Customer Representative is appoints by the top

19 5.5.2.1 3
Representative management or not?

Internal A) Is there any process is established for proper communication within the
20 5.5.3 3
Communication organization?

Management A) Is there any kind of records are available regarding the reviews done by
21 5.6.1 3
Review the management?

A) Does the top management review includes:-

Quality
1.Continual Improvements data
Management
22 5.6.1.1 2.Cost of Poor Quality 3
System
3.Customer Satisfaction index
Performance
4.Quality Objectives
A) Does the review includes the following data:-
1.Results of internal Audit
23 5.6.2 Review input 2.Customer Feedback 3
3.Status of corrective & Preventive Action
4.Previous review status

A) Is the decision or action taken by the top management in MRM are

24 5.6.3 Review Output 3
properly monitored?

6. RESOURCE MANAGEMENT

Provision of A) Is there is proper resources are available to implement & maintain the
25 6.1 3
Resources Quality Management System?

General A) To ensure the product quality is there any procedure or document is

26 6.2.1 (Human established by the organization to check the minimum competency level 3
Resources) of the personnel to satisfy that there is no effects on the product quality.

A) Does any type of comptence level is sets by an organization for all the
personnel performing in the organization?
Competence,
27 6.2.2 training & B) Is there is any Training procedure for improving the competency of 3
awareness personnel from minimum to maximum is available or not?

C) Records of training are available or not?

Product Design A) Is the skill of product design personnel is high in applicable tools &
28 6.2.2.1 3
Skill techniques?

A) Is the procedure of training is available or not?

29 6.2.2.2 Training 3
B) Does the training procedure includes the method for identifying the
training needs & competence mechanism?

Training on the A) Records for On job training againsts the new models or the regular
30 6.2.2.3 3
Job customer problems communicated to personnel are available or not?

Employee A) Is there is any process or procedure is available which motivate the

31 6.2.2.4 Motivation & employee to achieve the quality objectives & continual improvements in 3
Empowerment QMS?

A) Does the organization established the well organised building,

32 6.3 Infrastructure workspace, associated utilities, process equipments & supporting 3
services?

Plant, Facility &

A) Is the layout structure of plant is well designed for proper flow of
33 6.3.1 Equipment 3
material from incoming stage to outgoing stage?
Planning

A) For sustain during emergency situation is their any contigency plan

34 6.3.2 Contigency Plans 3
available or not?

Work A) Is there is suitable work enviornment for achieving the conformity the
35 6.4 3
Enviornment quality or other requirements of the product?

Personnel safety
to achieve
A) Is the suitable work enviornment for personnel is available during
36 6.4.1 conformity to 3
design & development & manufacturing Process?
product
requirements

Cleaniness of A) At manufacturing area proper cleaniness is maintained or product

37 6.4.2 3
Premises manufacturing area is free from dust or not?

7. PRODUCT REALIZATION

A) Is there is any process or planned activities from initial to final stage of

the product are available for new product introduction or product
Planning of
realization?
38 7.1 & 7.1.1 Product 3
Realization
B) Does all customer requiremnts are incorporated in the planning of
product realization?

Acceptance A) Does the organization follow any standard for acceptance level or any
39 7.1.2 3
Criteria other customer approved acceptance criteria?
 REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS

CLAUSE RESP. PERSON /

NO. PROCESS REQUIREMENTS CHECK POINTS Required Actual ACTION TAKEN
NO DATE

A) Does the organization ensures any confidentality of the customer-

40 7.1.3 Confidentially 3
contracted product?

A) Is there is any procedure is available for control over changes that

impact product quality & cause customer issues?

41 7.1.4 Change Control B) Does the changes verified & validate properly before implementing? 3

C) Does Necessary information about the changes which affects the

customer product is timely communicated to customer or not?

Determination of
A) Does all the customer requirements like pre & post delivery activities,
requirements
42 7.2.1 Statuatory & Regulatory requirements or any other requirements by the 3
related to the
customer are properly fullfilled or not?
product

Customer
designated A) Does all the special characterstics designated by the customer are
43 7.2.1.1 3
special used in a control manner?
characterstics

Review of A) Is all the requirements are fulffilled as per the contract review with
7.2.2 & requirements customer?
44 3
7.2.2.1 related to the
product B) All the amendments records are available or not?

Organization
A) Does there is any feasibility study data which confirms that the product
46 7.2.2.2 Manufacturing 3
is manufactured as per the contract review process with customer?
Feasibility

Customer A) Does the organzation have contain proper communication system to

47 7.2.3 3
Communication communicate with the customer?

Customer
A) Is the communication system with the customer is as per the customer
48 7.2.3.1 Communication 3
understanding language & Format?
(Supplemental)

Multidisciplinary
49 7.3.3.1 A) Is multidisciplinary approach is used while developing the new product? 3
Approach

A) While developing the new product is these activities are studied or not:-
Design & 1. Functional & Performance
50 7.3.2 Development 2. Applicable Statutory & regulatory requirements 3
Inputs 3. Past Model History
4. Special Characterstics & other essential details

A) Does product design includes all the relevant data of customer such as
special characterstics, identification & traceability method & packaging
condition of the product.
Product Design
51 7.3.2.1 3
Input B) Is all the past troubles history are available?

C) Targets for product life, realability, durability, maintainability are decided

or not.

A) What are the targets for productivity, process capability & cost?
Manufacturing
52 7.3.2.2 Process Design 3
B) Is there is any other specific requirements by the customer for the
Input
above points?

Special A) Does control plan includes all the special characterstics including
53 7.3.2.3 3
Characterstics customer specified or internal?

Design &
54 7.3.3 Development A) Is the Designed Product is a per the design input requirements? 3
Output

A) Does the product design output contains all the given relevant data:-
Design &
Development 1. DFMEA
55 7.3.3.1 3
Output 2. Product Special Charaterstics
(Supplemental) 3. Product Error Proofing detail
4. Product design review results

A) Does the Manufacturing Process Design Output contains all the given
relevant data:-

1. PFMEA
2. PFD
Manufacturing
3. Specification & Drawing
56 7.3.3.2 Process Design 3
4. Layout Plan
Output
5. Control Plan
6. Work Instructions
7. Acceptance Criteria
8. Data for quality, realability, maintainability & Measurability
9. Method of detection

Design & A) Is the design review frequency is defined or not?

57 7.3.4 Development 3
Review B) All records of design review are available or not?

58 7.3.4.1 Monitoring A) Is the measuring frequency or measuring stages are defined? 3

Design & A) Is all the planned activities during design development are continuosly
59 7.3.5 Development verify to ensure that all the activities is going as per plan & meets the 3
Verification design and development input requirements?

A) Is there is any validation process which ensure that the designed

Design &
7.3.6 & products should be capable to meets the customer requirements?
60 Development 3
7.3.6.1
Validation
B) Are all the validation records are available or not ?
 REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS

CLAUSE RESP. PERSON /

NO. PROCESS REQUIREMENTS CHECK POINTS Required Actual ACTION TAKEN
NO DATE

Prototype A) Are the Activities performed during prototype programme is exactly

61 7.3.6.2 3
Programme same with Mass production programme?

Product Approval A) Is there any procedure for Product Approval Process recognized by the
62 7.3.6.3 3
Process customer?

A) Is all the changes made by design & development are available?

Control of Design
63 7.3.7 & Development B) Are these changes properly reviewed or verified before implementing? 3
Changes
C) Is all the review records available?
A) Is GPA available or not?

Purchasing B) Is there any procedure available for supplier selection, evaluation & re-
64 7.4.1 3
Process evaluation process?

C) Are all the records of evaluations are maintained?

Statutory &
A) Are all the purchased products or material follows the statuatory &
65 7.4.1.1 Regulatory 3
regulatory requirements?
Conformity

Supplier Quality
A) Is there any supplier upgradation procedure or rule available?
Management
66 7.4.1.2 3
System
B) List of ISO 9001:2008 Certified suppliers?
Development

Customer
67 7.4.1.3 Approved N/A 3
Sources

Purchasing A) Is all the relevant information like approval of product, procedures,

68 7.4.2 3
Information processes & QMS system are properly communicated to supplier?

Verification of
A) Is there any procedure available for verification of purchased product
69 7.4.3 Purchased 3
which ensures the quality of the product?
Products

A) Is there any procedure available for verification of purchased product

Incoming Product which ensures the quality of the product?
70 7.4.3.1 Conformity to 3
requirements B) Are all these records like Reciept of incoming material, inspection
reports of products, Sampling plan, test reports of material are available ?

Supplier A) Is performance of all the suppliers are monitored or is there any

71 7.4.3.2 3
Monitoring procedure available for there performance monitoring?

A) Are all the relevant data for controlling the product confirmation is
available:-
Control of
1. Information regarding the product
72 7.5.1 Production & 3
2. Suitable Work Instruction
Service Provision
3. Use of suitable instruments as per inspection standard
4. Availability of all measuring instruments

A) Is Control plan available for all the parts?

73 7.5.1.1 Control Plan 3
B) Does it contain all relevant data as per ISO/TS Annex-A ?

A) Is there documented work instructions are displayed at all work stations

74 7.5.1.2 Work Instructions 3
for performing the work?

Verificatiion of Job A) Is there any confirmation method to verify the job at startup or ant
75 7.5.1.3 3
Set-ups change in tool or process?

A) Is there planned preventive maintenance plan available for the

machines?
Preventive &
76 7.5.1.4 Predictive 3
B) List of critical spares are available or not?
Maintenance
C) Are maintenance objectives are evaluate or revised time to time or not?

A) Is there appropriate resources for tooling & gauge design & their
fabrication available?
Management of
77 7.5.1.5 Production B) Is there any procedure available for tool & die management? 3
Tooling
C) Are all the records of tool change preventive maintenance,tool
identification,repair of tools, trial run & their storage available or not ?

Production
78 7.5.1.6 Does the production plan satisfy or fulfill the customer requirement or not? 3
Scheduling

Feedback of A) Is there any well communicate system developed by the organization

79 7.5.1.7 information from for the information of non conformities obtained from outside of its 3
service organisation?

Service
Does there is any service agreement signed with customer, if yes than that
80 7.5.1.8 Agreement with 3
is fulfilled or not?
Customer

Validation of
7.5.2 Processes for Is there any process or method available which validate the processes for
81 3
& 7.5.2.1 production & production before delivered to the customer?
Service provision
 REF. DOCUMENT & OBSERVATIONS DESCRIPTION DETAILS OF NC ROOT CAUSE ANALYSIS

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NO. PROCESS REQUIREMENTS CHECK POINTS Required Actual ACTION TAKEN
NO DATE

Identification & Is there any identification & traceability system available for control over
82 7.5.3 3
Traceability the product?

Customer
83 7.5.4 Not Applicable 3
Property

Customer Owned
84 7.5.4.1 Not Applicable 3
Property Tooling

A) During all stages from BOP parts to finished goods are the product
preservation facilities well established or not?
Preservation of
85 7.5.5 3
Product
B) Is the storage place doesn't effects the property of the components or
product?

Storage &
86 7.5.5.1 A) Is there any system available for stock rotation (FIFO) or stock buildup? 3
Inventory

A) Is there proper identification available on measuring instruments?

Control of
B) Is calibration plan available for all measuring instruments?
Monitoring &
87 7.6 3
Measuring
C) Does all the measuring instruments are procured in a safe manner?
Equipments
D) Does all the records of calibration are available?

A) For all measuring instruments & equipment MSA activity is done or not?
Measurement
88 7.6.1 3
System Analysis
B) All MSA records are available or not?

A) Are all the records of calibration are available or not ?

Calibration/Verific
89 7.6.2 3
ation records
B) Is out of specification reading data available or not ?

A) Is appropriate Lab scope available or not?

Internal
90 7.6.3.1 3
Laboratory
B) Is the suitable competency of Lab Incharge is defined or not ?

A) Lab Scope of external lab agency is available?

External
91 7.6.3.2 3
Laboratory B) Does the external Lab is approved by customer or certified by ISO/IEC
17025?

8. MEASUREMENT, ANALYSIS & IMPROVEMENT

Measurement
A) Is there any plan available for monitoring, measurement,analysis &
92 8.1 Analysis &
improvement which ensures the conformity of quality manage system?
Improvement

Identification of For each process is their appropriate tools are defined in a control plan or
93 8.1.1
Statistical Tools not?

Knowledge of
Does the member of organisation having basic knowledge about variation,
94 8.1.2 basic Statistical
control & Process capability or not?
Concepts

Customer Is there any kind of customer satisfaction survey conducts by which the
95 8.2.1
Satisfaction organisation measure the customer satisfaction index?

Is the customer satisfaction index conducts all the objectives :-

Customer
1. Delivered part quality Performance
96 8.2.1.1 Satisfaction
2. Customer Return Products
Supplemental
3. Delivery Schedule

A) Is there any internal audit plan made for checking the effectiveness of
QMS

97 8.2.2 Internal Audit B) Is there any documented procedure available for internal audit?

C) Verifying the status of all the previous NC's observed during internal
audit.

Quality
98 8.2.2.1 Management Same as above
System Audit

Manufacturing Does the organisation performs regular process audit to check the
99 8.2.2.2
Process Audit effectiveness of the process?

Is there any plan available for product audit which verifies the conformity
100 8.2.2.3 Product Audit
of all product dimensions & its Functionality?

A) Does all the internal audits done as per defined plan or not?
Internal Audit
101 8.2.2.4
Plans B) Are the frequency of internal audits revised if the interna/external non
conformities are observed regularly?

Internal Auditor
102 8.2.2.5 Does the internal auditor have brief knowledge of SQM & ISO/TS 16949?
Qualification
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NO DATE

Does the organisation used appropriate methods for monitoring &

Monitoring & measurement of quality management system processes?
103 8.2.3 Measurement of
Processes B) For any delay in planned activities is there any countermeasure taken
by the organisation or not?

For all the processes does the process study or process capability is
verified or not?
Monitoring &
B) Is there any reaction plan available if the process founds unstable?
Measurement of
104 8.2.3.1
manufacturing
C) All the records for tool change or machine repair are available or not?
Processes
D) For any unsatisfactory result is there corrective action taken against the
problem or not?

A) Is there any stages, measurement method & skills defined to verify the
Monitoring & product quality as per the product requirement?
105 8.2.4 Measurement of
Product B) Is there any evidence or document available which confirms that the
product manufactured as per as per the acceptance criteria?
A) Does layout inspection report contains all the dimensions mentioned in
Layout Inspection control plans?
106 8.2.4.1 & Functional
Testing B) Are all the functional testing done as per the plan mentioned in a
control plan?
A) For apperance items is there proper LUX level is maintained on lines as
per customer requirement

107 8.2.4.2 Appearance Items B) For apperance items is there any master sample is freezed which
defines the color, grain or texture levelof the product

C) Is there any evaluation period defines for master sample?

A) Is there any procedure available for product non conformity?

B) For non conforming product does the organization takes some action to
Control of Non-
eliminate the defects?
108 8.3 conforming
Product
C) Is re-verification done for the taken action against the non conformity?

D) All the records & evidences are available or not?

Control of Non-
conforming A) Is the suspected or idenified parts consider as a non conforming parts
109 8.3.1
Product or other?
(Supplemental)

A) For rework process is there any rework instructions available or not?

Control of
110 8.3.2 Reworked
B) Is there any process available to check the rework parts by the
Product
appropriate personnel?

A) Is there any deviation system is available for concession or deviation

parts in which the product or manufacturing process is different from that
which is currently approved?

111 8.3.4 Customer Waiver B) Does all the records of deviation are available?

C) All the taken deviations are approved by customer or not ?

D) Is same kind of control system is available for suppliers also?

A) Is there any evaluation of their QMS system done by the organisation

for continual improvement?
112 8.4 Analysis of Data
B) Does the data analysis is done with respect to the factors like customer
satisfaction, conformity to product requirement, preventive action result &
its effectiveness & suppliers quality?

A) Is there any data available which shows the status of current vs

Analysis & use of
113 8.4.1 planned performance towards the objectives or goals set by the
Data
organisation?

A) Does the organization continually improves the effectiveness of QMS

Continual
114 8.5.1 system with the help of quality policy, objectives, audit results, analysis of
Improvement
data,corrective & preventive action & management review?

Continual
A) Is there any process define by the organization for continual
115 8.5.1.1 Improvement of
improvement?
the Organization

Manufacturing
A) Is there any improvement activity is going on to reduce the variation in
116 8.5.1.2 Process
product characterstics & manufacturing process parameters?
Improvement

A) For eliminating the reoccurence of problem is there possible corrective

action taken or not?
117 8.5.2 Corrective Action
B) Is there any documented procedure or method adopted which shows
the result/record of all nonconformities, their action, root cause taken
against the problem & their implementing status are effective?

A) For solving the problem is there any format used by the organization
118 8.5.2.1 Problem Solving which contains all the detail about the problem, root cause identification or
any customer suggested format is used or not?

A) Does the organization use possible error proofing methods while taking
119 8.5.2.2 Error Proofing
any corrective action?

A) Is all the analysis records of rejected parts are available?

Rejected Product
120 8.5.2.4
Test Analysis B) For prevent reoccurence of rejection is suiable corrective or preventive
action is taken or not?
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NO DATE
A) For eliminating the reoccurence of problem preventive action taken or
not?
121 8.5.3 Preventive Action
B) Is there any documented procedure or method adopted which shows
the result/record of all nonconformities, their action, root cause taken
against the problem & their implementing status are effective?

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