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IMS - IQA AUDIT CHECK LIST

Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

Unintended use of obsolete documents.

4.2.4

4.5.4

Whether they have established the control of Records?

4.2.4

4.5.4

Records are Legible and Readily Available

4.2.4

4.5.4

CSR

4.2.4

4.5.4

10

5.5.1

4.4.1

11

5.5.1

4.4.1

What to look for

Result

RecordControl

Document Control

Whether they have established the control of Documents?


Latest Revision of Documents available at point of use.
Legible and Readily identifiable.

Storage method & retention of records?


Are they retained the"D" / Safety / Traceability related records for 15 years?

Latest Revision of formats available at point of use.


Responsibility & Authority

Form No. F/MR/06

Title

Whether Responsibility & Authority of they established and known to the personnel?

Is there KRA assigned for all personnel & is it linked with company objectives?

Page No. 1 of 123

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Auditor
Auditee
S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

12

CSR

13

5.5.3

14

6.3.2

Form No. F/MR/06

Internal
Contingency Communicat Responsibility & Authority
ion

IMS - IQA AUDIT CHECK LIST

Title

Date
Department
What to look for

Result

Are they Identified & defined responsible person for updating PTDB?

Whether they has established the internal communication regarding internal rejection, customer
complaints / rejection, online rejection, Process audit observations and Product audit
observations ?

Whether they has established the contingency plan for the critical measuring equipments &
Replacement plan for key Inspection activities?

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

15

6.2.2.2

Do they have a defined guideline for training to ensures that competent personnel performing
work affecting product quality?

16

6.2.2.2

Is competency requirements are defined on the basis of appropriate education, training, skills &
experience?

17

6.2.2.2

18

6.2.2.2

19

6.2.2.2

20

6.2.2.2

Do they have sufficient training records such as attendance sheet, class room / theoretical test
questionnaires & evaluation sheet?

21

6.2.2.2

Do they have defined qualification criteria for each skill & are they updated the skill matrix
accordingly?

22

7.3.3.2

Whether they have guide line for preparing the Process FMEA & Control plan & Is it developed
according to AIAG manual?

23

CSR

Is all potential failure modes & it's effects in all stages are considered & developed?
(Next process, Subsequent Process, Customer & End user)

24

CSR

Are they considered maximum Severity, Occurrence and minimum value of Detection, while
calculating RPN?

Form No. F/MR/06

Training & Development

Title

What to look for

Result

Are they identified the training needs based on the competency requirements & is training plan
developed accordingly?
Do they have a training aids / materials each topic / skill wise & is it updated regularly?

Are they carried out the training as per the plan or not?

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

25

7.3.3.2

Do they considered the PTDB, while preparation of PFMEA & Is PTDB updated regularly?

26

CSR

Are they maintained cause wise/defect wise internal rejection data , customer complaint data &
Based on the real data the occurrence rating calculated or not?

27

CSR

Are they reviewed & updated the occurrence rating (Matrix) as per the defined frequency?

28

7.3.3.2

Is SOD rating & Identification of CC/SC characteristics are as per the latest AIAG FMEA
guideline / WI for FMEA?

29

CSR

Do they have a defined RPN reduction rules based on SOD matrix, SO & Is action initiated
accordingly to reduce the RPN??

30

CSR

Ia all the above check points are addressed in PFMEA review check list to avoid the missing of
any important points & are they utilized the same?

31

CSR

Is PFMEA periodical review frequency defined & Is it updated regularly as when required?

32

7.3.3.2

Is all process / product characteristics identified in CP & is it linked with PFMEA?

33

CSR

Are they defined a standard like QFD to decide the product - process characteristic relation
shipmatrix?

34

7.3.3.2

Do they have a phase wise control plan? (Proto type, Pre-launch & production)& adequate
control methods defined accordingly?

Form No. F/MR/06

ontrol Plan

FMEA

Title

What to look for

Page No. 4 of 123

Result

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

35

CSR

36

CSR

Are they reviewed the control plan accordingly change in control methods?

37

7.3.3.2

Is Control plan periodical review frequency defined & Is it updated regularly as when required?

38

7.3.3.2

Is CP check list to avoid the missing of any important points & are they utilized the same?

Form No. F/MR/06

Control Plan

Title

What to look for

Result

Are they defined the guideline to change control method according to change in the gravity?

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department
TS
Clause
Ref.

EHS
Clause
Ref.

39

7.4.3.1

40

7.4.3.1

41

7.4.3.1

42

7.4.3.1

43

7.4.3.1

44

7.6.2

Form No. F/MR/06

What to look for

Result

Whether they have defined mechanism for carrying out incoming inspection ?
Is all purchased materials are verified as per control plan & sufficient inspection records
available? (ie.supplier & Internal - TC)
Are adequate receiving inspection and test facilities, equipment, standards & workmanship
provided and used for the required inspections and tests?

Is all concerns noticed at receipt stage communicated to supplier through SCAR?

Are they maintained SCAR register & Effectiveness of SCAR being monitored?

Whether they have defined mechanism for carrying out calibration and is it covered,
a) All the monitoring & measuring Instruments / equipments?
b) Calibration frequency (based on what)?
c) Method of calibration, environment condition & qualification of personnel ? (for In-house
calibration)
d) Acceptance criteria?
e) Correction in case of out of tolerance situation?

Do they have any defined unique identification methods to identify,


a) Identification No.
b) calibration status?
c) Validity of calibration?
D) MMD does not require calibration?

Calibration

45

7.6.2

Title

Verification of Incoming Materials

S. No.

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

46

7.6.2

47

7.6.2

Do they have sufficient records of calibration & is it verified before release of instruments for
usage?

48

7.6.3.2

Is your calibration lab accredited to or meet the intent of ISO/IEC 17025 or national equivalent?

49

7.6.3.1

Do they have lab scope of calibration lab, Master instruments calibration certificates to prove the
traceability to international or national standards?

50

7.6.2

Do they have any positive recall methods to identify the previous measurement results &
notification to customer when suspected parts delivered, if in the case of MMD out of calibration
situation?

Form No. F/MR/06

Calibration

Title

What to look for

Result

Do they have a plan for calibration & are they calibrated the MMD as per plan or not?

Page No. 7 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

51

7.6.1

Do they have a plan for MSA & are they conducted the study as per plan or not?

52

7.6.1

Are they used appropriate statistical MSA study methods to qualify (R&R, Bias, Linearity,
Stability) & do they have sufficient records for it?

53

7.6.1

Do they have any periodical verification & preventive maintenance methods to ensure the
condition of MMD? (apart from periodic calibration activity)

54

8.2.2.2 /
8.2.2.3

Whether they have defined mechanism for carrying out the process / product audit?

55

CSR

Are they carried out D/TLD audit as per the defined frequency
(for VW parts)?

56

8.2.2.2 /
8.2.2.3

57

8.2.2.2 /
8.2.2.3

58

8.2.2.2 /
8.2.2.3

59

8.2.2.2 /
8.2.2.3

Form No. F/MR/06

Process / Product Audit

MSA

Title

What to look for

Result

Do they have annual audit schedule & is it covered all manufacturing process / products?
Whether they have a defined criteria for selection of auditors & sufficient qualification records
maintained for it?
Are they carried out the process / product audit as per schedule & do they have sufficient
records for it?
Are they maintained audit concern register & status and effectiveness of CAPA being monitored
& tracked?

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

60

8.2.3

61

8.2.3

62

8.2.3

63

8.2.4

Whether they have defined mechanism for carrying out in-process inspection ?

64

8.2.4

Whether they identified appropriate sampling plans, measuring techniques , for acceptance of
product at appropriate stages of product realization & is it effectively followed?

65

8.2.4

Are adequate In-process inspection and test facilities, equipment, standards & workmanship
provided and used for the same?

66

8.2.4

67

8.2.4.2

68

8.2.4

Are they have defined mechanism to communicate the quality concerns during product
realization stages

69

8.2.4

Are they maintained quality concern register & Effectiveness being monitored?

Form No. F/MR/06

In-Process Inspection

Monitoring and Measurement


of Process.

Title

What to look for

Result

Whether they has established the process measures which affect the customer requirements?

Are they monitoring the process measures periodically?

Is all the process measures are under controlled?


If not are they developed the action plan to improve further?

Whether the product conformity is done by authorized personnel & Qualification records
available?
Whether they has established appropriate resources ( lighting norms ) for evaluating
appearance items ? Ex: Master samples ( For color , texture , Distinctness of Image)

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department
TS
Clause
Ref.

EHS
Clause
Ref.

70

8.2.4.1

71

8.2.4.1

72

8.2.4.1

73

8.2.4.1

Form No. F/MR/06

Title

Layout & Functional testing

S. No.

What to look for

Result

Whether they has identified a mechanism for carrying out layout & Functional testing?

Do they have plan for layout / functional testing & is it covered all products?
Are they carried out the layout inspection as per schedule & do they have sufficient records for
it?
Are they ensured for all dimensions, material specification , fit / functional requirements as
specified in drawing & engineering specification?

Page No. 10 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department
EHS
Clause
Ref.

74

8.3.1

75

8.3.1

76

8.3.1

77

8.3.3

78

8.3.4

79

8.3.4

80

8.5.2

81

8.5.3

82

8.5.3

Form No. F/MR/06

Title

Control of NC parts

TS
Clause
Ref.

Customer
In-House rejection analysis Customer waiver Informatio
n

S. No.

What to look for

Result

Whether they identified the NC parts as per the defined guidelines?

Are they kept / stored the NC parts in Inspection area as per defined layout?

Do they have upto date quarentine register &


Is physical quantity matching with register?

Whether they has identified a mechanism for informing customers if any NC prodcut is shipped ?

Whether they has established a mechanism for customer concession or deviation if any product
or manufacturing process is different from that which is currently approved ?

Whether they has having enough records for justifying the above ?

Are they monitored the effectiveness & recurrence at a defined timeline and is it effective?

Are they updated the relevant documents accordingly such as PFMEA,CP,PTDB, WI & etc.?

Are they identified & implemented the horizontal deployment for similar process / products?

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Auditor

Date

Auditee

Department
TS
Clause
Ref.

EHS
Clause
Ref.

83

CSR

84

CSR

85

CSR

86

CSR

Form No. F/MR/06

Title

Information analysis on warranty

S. No.

What to look for

Result

Are they defined the alarm level for No. of claim /month, Modelwise, production monthwise,
customerwise, Dealerwise, kilometerwise, defectwise & NTF?
Are they updated the Market claim information record & Warranty return analysis monitoring
sheet periodically?

Are they carried out the action planbased on the alarm level?
Do they have defined phenomenawise analysis flow, with the associated method and the tool
used?
For example (Water leakage), first I perform a visual check, How? With which master sample to
compare / 2nd if OK I perform dimensional check, method to be used and tools to be used +
specification

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

87

8.5.2

Whether they have a defined guideline to carry out corrective & preventive actions for customer /
warranty concerns?

88

CSR

Are they defined the timeline for each step of cause analysis from containment action, CAPA
implementation, Standardization etc.

89

8.5.2

Are they identified the root cause analysis by using problem solving techniques such as brain
storming, cause & effect diagram, why-why analysis & etc and are they validated the potential
root cause?

90

CSR

Are they validated possible causes through observation, trials to arrive at probable causes?

91

CSR

92

8.5.2

93

8.5.2

94

CSR

Are they updated the relevant documents accordingly such as PFMEA,CP,PTDB, WI & etc. & do
they have check list?

95

8.5.3

Are they identified & implemented the horizontal deployment for similar process / products?

Form No. F/MR/06

Customer / Return part analysis

Title

What to look for

Result

Are they used QC tools such as why why analysis for deriving root causes for Occurrence &
Escape?

Are they implemented the suitable corrective actions with in defined timeline?

Are they monitored the effectiveness & recurrence at a defined timeline and is it effective?

Page No. 13 of 123

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Customer /

IMS - IQA AUDIT CHECK LIST

Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

96

8.5.2

Title

What to look for

Result

Are they monitored / improved the lead to response / close the quality concerns raised by
customer within timeline as defined by customer?

Any other observations, if any (Use additional sheet, if required)

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor NonConformity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

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Objective Evidence

Form No. F/MR/06

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QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

Form No. F/MR/06

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Objective Evidence

rmity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

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Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

Ref.

EHS
Clause
Ref.

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

Unintended use of obsolete documents.

4.2.4

4.5.4

Whether they have established the control of Records?

4.2.4

4.5.4

Records are Legible and Readily Available

4.2.4

4.5.4

CSR

4.2.4

4.5.4

10

4.3.1

11

4.3.1

Title

What to look for

Record Control

Document Control

Whether they have established the control of Documents?


Latest Revision of Documents available at point of use.

Legible and Readily identifiable.

Storage method & retention of records?


Are they retained the"D" / Safety / Traceability related records for 15 years?
Latest Revision of formats available at point of use.

Hazard identification
& Risk assesment

TS

S. No. Clause

Are aspects/impacts & hazards/risks identified and Significant study conducted as per the rating
guidelines?
Are study reports reviewed and updated for
-After implementation of Objectives (Management Program)
-After occurrence of any accident / emergency

Result

IMS - IQA AUDIT CHECK LIST


Date

Auditee

Department
Title

12

4.3.3

13

5.5.1

4.4.1

14

5.5.1

4.4.1

15

5.5.3

16

CSR

17

CSR

18

6.2.2.2

Do they have a defined guideline for training to ensures that competent personnel performing
work affecting product quality & Including EHS related skills?

19

6.2.2.2

Do they have a competent personnel performing significant activities related to EHS interms of
education, training, skills and experience?

20

6.2.2.2

Is competency requirements are defined on the basis of appropriate education, training, skills &
experience?

21

6.2.2.2

Are they identified the training needs based on the competency requirements & is training plan
developed accordingly?

Internal Communication
opment

TS

S. No. Clause

Responsibility &
Authority

Ref.

EHS
Clause
Ref.

Objectives
& Target

Auditor

What to look for

Is EHS Management Programs made for all EHS objectives and implemented?

Whether Responsibility & Authority of they established and known to the personnel?

Is there KRA assigned for all personnel & is it linked with company objectives?
1.Whether they has established the internal communication regarding
Internal rejection status & action plan, Productivity, Safety, Customer dissatisfactions, Process
audit observations and Product audit observations ?
Are they displayed the quality result graph like customer ppm trend, in-house ppm trend , pareto
chart, daily rejection monitoring chart?.
Are they displayed the monthly trends & action plan status with target dates, responsibility &
status at the communication area?

Result

IMS - IQA AUDIT CHECK LIST


Auditee

Department

Ref.

EHS
Clause
Ref.

22

6.2.2.2

23

6.2.2.2

24

6.2.2.2

Are they carried out Theoritical / Practical evaluation of the operator after training?

25

6.2.2.2

Do they have sufficient training records such as attendance sheet, class room / theoretical test /
practical test questionnaires & evaluation sheet?

26

6.2.2.2

Do they have defined qualification criteria for each skill & are they updated the skill matrix
accordingly each operator-wise?

27

6.2.2.2

Are they carried out the operator observation after training to evaluate the effectiveness of
training program & is it includes re-training?

28

6.3.2

Contingency

Date

Whether they has established the contingency plan for the Key equipments failure, Manpower
shortage, Material shoratge, Delivery failure?

29

6.4.2

5S

Auditor

Are they following & maintained the work place environment based on 3C & 5S concepts?

Title
Training & Development

TS

S. No. Clause

What to look for

Do they have a training aids / materials each topic / skill wise & is it updated regularly?

Are they carried out the training as per the plan or not?&
Is it effective?

Result

IMS - IQA AUDIT CHECK LIST


Date

Auditee

Department
Title

30

7.5.1

31

4.4.6

32

4.4.6

33

4.4.6

34

4.4.6

35

7.5.1.6

36

7.5.1.6

37

7.5.1.6

What to look for


Are the inputs identified for carrying out the production and service provisions under controlled
conditions?
a)
Characteristics of product
b)
Work instructions if necessary
c)
Suitable equipment
d)
Availability and use of monitoring and measuring devices
e)
Implementing monitoring and measurement
f)
Implementation of release, delivery and post delivery activities.

Whether they have established the OCP for smooth functioning of the EHS process?
Operational Control

Ref.

EHS
Clause
Ref.

Is Operational control effective to control situations where their absence could lead to deviations
from the EHS policy and the objectives?
Whether the OCP's are derived from EHS risk assesment study & is it linked?
Is it accessible for use at work station?
Is activity performing by the personnel effectively adhered to OCP &
Are PPEs effectively used, wherever required?

Production Planning

TS

S. No. Clause

Control of production

Auditor

Are they have material requirement plan considering the rolling plan & stock availability?
Is production planned according to customer requirements?
Are they monitoring the production plan vs. actual & Suitable action initiated in case of non
achievement?

Result

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

7.5.1.2

39

7.5.1.2

40

7.5.1.3

41

7.5.1.3

42

7.5.1.3

43

7.5.2

44

CSR

45

CSR

Work Instruction

38

Title

Verification of Job set-ups

Ref.

EHS
Clause
Ref.

Process Validation

TS

S. No. Clause

What to look for

Whether they have established the work instructions for smooth functioning of the process?

Whether the work instructions are derived from control plan & is it linked?
Is it accessible for use at work station?

Are setup instructions available for setup personnel?

When and how the Job Setups are verified? Are statistical methods used during verification,
where applicable?

Is production carried out after approval or not?

Are manufacturing processes validated & revalidated?

Are they conducted trials, with details of product characteristics achieved as an output for
different values and different combinations of process parameters?
Are they conducted the feasibility review and record for the same has to be maintained for all
the process change identified?

Result

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

Ref.

EHS
Clause
Ref.

46

CSR

47

CSR

48

CSR

49

CSR

50

CSR

Are they have defined criteria for conducting PPAP for process changes i.e. for which changes
PPAP is required from customer & Internal?

51

CSR

Do they have approved internal / customer PSW copy & records for all changes related to
process?

52

7.5.3

53

7.5.3

54

7.5.3

55

8.2.3

Title

What to look for

Process Change management

Whether they checked all the possible risks including stock loss, quality crisis, equipment / tool
break downs, non achievement of timing plan etc and actions to be planned for the same?

surement
Identification & Traceability
.

TS

S. No. Clause

Are they prepared the list of process / plant related changes and progress control tracked or
not?
Are they tracked the progress of the each action related to the change including the relevant
document updation and implementation?
Are they monitored the effectiveness of actions implemented (i.e. comparison of pre and post
change data like rejection, Cp/ CpK values etc)

Do you have a documented process for the identification of products throughout product
realization process by means of unique identification of the products?
Is product status identified with respect to monitoring and measurement requirements?

Is product traceability system followed & Is it traceable from delivery to receipt of child parts?

Whether they has established the process measures such as set-up & process rejections at all
manufacturing stages,Machine utilization, OEE?

Result

IMS - IQA AUDIT CHECK LIST


Date

Auditee

Department
TS

Ref.

EHS
Clause
Ref.

56

8.2.3

57

8.2.3

S. No. Clause

Monitoring and Measurement


of Process.

Auditor

Title

What to look for

Are they monitoring the process measures periodically?

Is all the process measures are under controlled?


If not are they developed the action plan to improve further?

Result

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

Ref.

EHS
Clause
Ref.

58

8.2.3.1

Are they following the process capability study for CC / SC characteristics?

59

8.2.3.1

Whether they has corrective action plan ( should include specific time and assigned
responsibilities to assure process becomes stable or capable ) for characters whose CpK is less
than 1.33 ?

60

8.2.3.1

61

CSR

62

CSR

63

CSR

Are they defined and performed the retroactive confirmation for the NC's related to safety
parameters?

64

CSR

Are they trained all the operators for the defined NC handling for safety parameters?

Title

Statistical Process control

TS

S. No. Clause

What to look for

Are they recording the significant process events such as machine / parameter adjustment, tool
change or machine repair?
Are they Identified Special / Critical characteristics on all relevant documents?
Are they maintained specific recording sheet, action sheet for NC's related to safety
parameters?

Result

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

Ref.

EHS
Clause
Ref.

65

CSR

Whether they have identified a mechanism for control of non conforming product with time line &
responsibility?

66

CSR

Are they given training to all operators for NC handling based on defined guideline?

67

8.3.1

Is Nonconforming products identified and stored in designated area and is it controlled?

68

CSR

69

8.3.1

70

CSR

71

CSR

72

8.3.1

Work instructions are accessible to the employees doing re-working and is it displayed?

73

8.3.1

Are they maintained the rework register up to date & are action includes the corrective action?

74

CSR

Are they established a system to cross check the number of parts in the non conformity box
with the number of defects in the record?

75

CSR

Control of NC Parts & Rework parts

Title

Unusual" product
and equipment
situation

TS

S. No. Clause

What to look for

Do they have defined shift wise / day wise defective targets in order to control the out flow of
defect and take immediate corrective action?
Whether they has identified a mechanism for control of reworked product such as list of rework
able & non rework able defects with rework instructions?
Is acceptance criteria after rework defined & adhered accordingly?
Are they Identified the area for rework & is it secured against part-mix up with regular lot?

Have to define the format to capture the retroactive actions taken

Result

IMS - IQA AUDIT CHECK LIST


Date

Auditee

Department

Ref.

EHS
Clause
Ref.

76

CSR

77

8.4.1

78

8.5.1.1

79

8.5.1.2

80

8.5.2

81

8.5.2

82

8.5.2

83

8.5.2

Title

What to look for

Have to record the retroactive confirmation results in the defined format.


Are they established the mechanism for the analysis of data through statistical concepts?
1. Internal rejections & on line rejections?
2. Process Problems?
3 Negative trend of OEE / process measures?
Whether they has identified the areas for continual improvements?
No of Improvements
No of Kaizens done.
No of Environmental Management Programs

Whether they has identified a mechanisn for manufacturing process improvement to control &
reduce variation in product characteristics & Process parameters ?

Whether they have a defined guideline to carry out, In-house concern analysis?
In-House rejection analysis

TS

S. No. Clause

Manufacturing
"Unusual" product
Continual
Analysis of
Process
and equipment
Improvement
data
Improvement
situation

Auditor

Are they carried out the quality review meeting internally at a defined frequency along with
CFT?
Do they have register for In-house concerns & are they monitored the progress status and
reviewed periodically?
Are they identified the root cause analysis by using problem solving techniques such as cause &
effect diagram, why-why analysis & etc and are they validated the potential root cause?

Result

TS

Ref.

EHS
Clause
Ref.

8.5.2

S. No. Clause

84

85

8.5.2 &
8.5.3

In-House rejection analysis

Auditee

Title

Date
Department
What to look for

Are they implemented the suitable corrective actions with in defined timeline?

Corrective &
Preventive action

Auditor

IMS - IQA AUDIT CHECK LIST

Whether they has initiated the corrective action for the non conformities observed during?
1) Negative Trends of the Process Measures
2) Not able to achieve the established targets
3) Internal NCRs raised from the interrelated departments
4) IQA NCRs
5) External Audit Findings

Result

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department
TS

S. No. Clause
Ref.

EHS
Clause
Ref.

Title

What to look for

Result

Any other observations, if any (Use additional sheet, if required)

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor NonConformity, MAJ.NC : Major Non Conformity

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

QA AUDIT CHECK LIST

Objective Evidence

IMS - IQA AUDIT CHECK LIST


Auditor
Auditee
S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

Unintended use of obsolete documents.

4.2.4

4.5.4

Whether they have established the control of Records?

4.2.4

4.5.4

4.2.4

4.5.4

4.2.4

4.5.4

5.5.1

4.4.1

Form No. F/MR/06

Title

What to look for

Result

Record Control

Document Control

Whether they have established the control of Documents?

Latest Revision of Documents available at point of use.

Legible and Readily identifiable.

Records are Legible and Readily Available

Storage method & retention of records?

Responsibility &
Authority

Latest Revision of formats available at point of use.

Whether Responsibility & Authority of they established and known to the personnel?

Page No. 53 of 123

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Auditor

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

10

5.5.1

4.4.1

11

5.5.3

12

6.3.2

Form No. F/MR/06

Internal
Responsibility &
Contingency Communicat
Authority
ion

Auditee
Title

What to look for

Result

Is there KRA assigned for all personnel & is it linked with company objectives?

Whether they has established the internal communication regarding material requirements,
Performance status, Supplier APQP status & etc?

Whether they has established the contingency plan for purchasing materials?

Page No. 54 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor
Auditee
S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

13

7.4.1

Is there a documented procedure for selection, evaluation & re-evaluation of suppliers & is it
followed?

14

7.4.1

Whether they have evaluated and selected the supplier based on their ability to supply product
prior to release of product?

15

7.4.1

Is up to date approved Supplier / Sub-Contractor list maintained?

16

7.3.6.3

Are they monitoring the sub-supplier APQP readiness review & state the frequency?

17

7.3.6.3

18

7.4.1

When issuing purchase orders, is supplier quality history considered in continuing operations
with the supplier?

19

7.4.1

Whether they have a supplier audit schedule and are they conducted periodic supplier
assessment to conform the quality performance? (State the frequency)

20

7.4.1

Whether they have any defined mechanism for sub-supplier change management to obtain your
approval prior to implementation of any changes?

Form No. F/MR/06

Purchasing process

Title

What to look for

Result

Is product and process approval procedure is (eg PPAP) applied to suppliers / subcontractors

Page No. 55 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor
Auditee

21

7.4.1.2

22

7.4.1.3

23

7.4.2

24

7.4.2

25

7.4.2

26

7.4.3.2

27

7.4.3.2

Form No. F/MR/06

Title

Purchasing Information

EHS
Clause
Ref.

Supplier Monitoring

TS
Clause
Ref.

Supplier
Customer
QMS
approved
developme
Sources
nt

S. No.

What to look for

Result

Whether all suppliers are ISO 9001: 2008 certified ?

Whether the organization is purchasing the product , materials , or services from customer
approved sources ?

Whether purchase order consists of all relevant information about the product ?
Are purchasing information including EHS requirements adequately communicated to the
suppliers / subcontractors through purchase order or through work order / LETTER?
Is adequacy of purchase document reviewed and approved prior to release to suppliers?
Is there a documented supplier rating system, which includes
a) Delivered Product quality
b) customer disruptions including field returns
c) Delivery schedule performance
d) Premium Freight?
Are supplier ratings recorded, communicated back to the supplier, and appropriate action plans
obtained from poor performing suppliers?

Page No. 56 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

TS
Clause
Ref.

EHS
Clause
Ref.

Title

28

8.5.2 &
8.5.3

29

8.2.3

30

8.2.3

31

8.2.3

Monitoring and Measurement


of Process.

S. No.

Corrective &
Preventive action

Auditee
What to look for

Result

Whether they has initiated the corrective action for the non conformities observed during?
1) Negative Trends of the Process Measures
2) Not able to achieve the established targets
3) Internal NCRs raised from the interrelated departments
4) IQA NCRs
5) External Audit Findings

Whether they has established the process measures such as Supplier PPM, %Supplier rating in
A grade, No.of premium freight & etc?

Are they monitoring the process measures periodically?

Is all the process measures are under controlled?


If not are they developed the action plan to improve further?

Any other observations, if any (Use additional sheet, if required)

Form No. F/MR/06

Page No. 57 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor
Auditee
S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

Title

What to look for

Result

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor Nonconformity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

Page No. 58 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 59 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 60 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 61 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 62 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 63 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 64 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

Unintended use of obsolete documents.

4.2.4

4.5.4

Whether they have established the control of Records?

4.2.4

4.5.4

4.2.4

4.5.4

4.2.4

4.5.4

4.3.1

10

4.3.1

Form No. F/MR/06

Title

Danesh (for material planning)

Result

Record Control

Document Control

Whether they have established the control of Documents?

Latest Revision of Documents available at point of use.

Legible and Readily identifiable.

Records are Legible and Readily Available

Storage method & retention of records?

Hazard identification &


Risk assessment

Latest Revision of formats available at point of use.

Are aspects/impacts & hazards/risks identified and Significant study conducted as per the rating
guidelines?
Are study reports reviewed and updated for
-After implementation of Objectives (Management Program)
-After occurrence of any accident / emergency

Page No. 65 of 123

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IMS - IQA AUDIT CHECK LIST


Date

Auditee

Department
TS
Clause
Ref.

EHS
Clause
Ref.

Title

11

4.3.3

12

5.5.1

4.4.1

13

5.5.1

4.4.1

Form No. F/MR/06

Responsibility &
Authority

S. No.

Objectives
& Target

Auditor

Danesh (for material planning)

Result

Is EHS Management Programs made for all EHS objectives and implemented?

Whether Responsibility & Authority of they established and known to the personnel?

Is there KRA assigned for all personnel & is it linked with company objectives?

Page No. 66 of 123

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Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

14

5.5.3

15

6.2.2.2

16

6.2.2.2

17

6.2.2.2

18

6.3.2

19

6.4.2

5S

Date

20

7.5.1.2

Work
Instructio
n

Auditor

21

7.5.1.6

22

7.5.1.6

Internal
Contingency Training & Development Communicatio
n
Production Planning

Form No. F/MR/06

Title

Danesh (for material planning)

Result

Whether they has established the internal communication regarding


current status of Objectives, Performance Indicators, Safety, Customer dissatisfactions & Audit
observations (Internal / External)?

Are they carried out the training as per the plan or not?
Do they have a defined guideline for training to ensures that competent personnel performing
work affecting product quality & Including EHS related skills?
Is competency requirements are defined on the basis of appropriate education, training, skills &
experience?

Whether they has established the contingency plan for the Key equipments failure, Manpower
shortage, Material shortage, Delivery failure?

Are they following & maintained the work place environment based on 3C & 5S concepts?

Whether they have established the work instructions for smooth functioning of the process?

Are they have material requirement plan considering the rolling plan & stock availability?

Is production planned according to customer requirements?

Page No. 67 of 123

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IMS - IQA AUDIT CHECK LIST


Date

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

23

7.5.1.6

24

4.4.6

25

4.4.6

26

4.4.6

27

4.4.6

Form No. F/MR/06

Title

Department
Danesh (for material planning)

Result

Are they monitoring the production plan vs actual & suitable action initiated in case of nonachievement?
Whether they have established the OCP for smooth functioning of the EHS process?

Operational Control

Auditee

Production Planning

Auditor

Is Operational control effective to control situations where their absence could lead to deviations
from the EHS policy and the objectives?
Whether the OCP's are derived from EHS risk assessment study & is it linked?
Is it accessible for use at work station?
Is activity performing by the personnel effectively adhered to OCP &
Are PPEs effectively used, wherever required?

Page No. 68 of 123

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Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

28

7.5.5.1

Whether they have defined mechanism for the receipt of all Bought out parts, consumables, &
Packing materials ?

29

7.5.5.1

Whether they have identified a mechanism for identification, handling , storage and protection of
the product ?(Stores Layout)

30

7.5.3

31

7.5.3

32

7.5.5.1

33

7.5.5.1

34

7.5.5.1

35

7.5.5.1

Whether they have identified a location for keeping waiting for inspection & non confirmed
material ?

36

7.5.5.1

Do they have a defined location for packing & storage of FG parts & is it secured to avoid mixup of SFG / NC parts?

37

7.5.1.2

Do they have defined packaging instructions (parts wise) & is it being followed accordingly?

Child parts - Storage & Inventory Management


& Transport

Form No. F/MR/06

Title

Danesh (for material planning)

Result

Is all the materials are having valid identification tag with approval status?

Is all the Raw materials / Child parts are traceable, till supplier traceability details?

Whether they are following inventory management system & is it effective?


(To optimize inventory turn over time and assure stock rotation)

Whether the organization is following FIFO ?

Are they preserved the materials from dust, damage, deformation & etc?

Page No. 69 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

38

7.5.5.1

39

7.5.3

40

7.5.3

41

7.5.5

Are they preserved the materials from dust, damage, deformation & etc?

42

Are they delivered the materials as per the customer schedules & are they monitoring the
delivery performance?

Packing, Storage & Transport

Title

Danesh (for material planning)

Result

Are they implemented the FIFO mechanism for all parts in stock?
Is all the materials are having valid identification tag with approval status?
Is all the SFG / FG PFT's are traceable, till supplier traceability details?

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor Nonconformity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

Page No. 70 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 71 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 72 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 73 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 74 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 75 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 76 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

EHS
TS Clause
Clause
Ref.
Ref.

Title

What to look for

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

Unintended use of obsolete documents.

4.2.4

4.5.4

Whether they have established the control of Records?

4.2.4

4.5.4

4.2.4

4.5.4

4.2.4

4.5.4

4.3.1

10

4.3.1

11

4.3.3

Form No. F/MR/06

Whether they have established the control of Documents?

RecordControl

Document Control

Result

Latest Revision of Documents available at point of use.


Legible and Readily identifiable.

Records are Legible and Readily Available


Storage method & retention of records?

Objectives
& Target

Hazard
identification &
Risk assesment

Latest Revision of formats available at point of use.


Are aspects/impacts & hazards/risks identified and Significant study conducted as per the rating
guidelines?
Are study reports reviewed and updated for
-After implementation of Objectives (Management Program)
-After occurrence of any accident / emergency
Is EHS Management Programs made for all EHS objectives and implemented?

Page No. 77 of 123

Rev.No. 1

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Auditor

Date

Auditee

Department
EHS
TS Clause
Clause
Ref.
Ref.

Title
Responsibility &
Authority

S. No.

What to look for

5.5.1

4.4.1

13

5.5.1

4.4.1

14

5.5.3

15

6.2.2.2

Do they have a defined guideline for training to ensures that competent personnel performing
work affecting product quality & Including EHS related skills?

16

6.2.2.2

Do they have a competent personnel performing significant activitites related to EHS interms of
education, training, skills and experience?

17

6.2.2.2

Is competency requirements are defined on the basis of appropriate education, training, skills &
experience?

18

6.2.2.2

19

6.2.2.2

20

6.2.2.2

Form No. F/MR/06

Training & Development

Internal
Communicatio
n

12

Result

Whether Responsibility & Authority of they established and known to the personnel?

Is there KRA assigned for all personnel & is it linked with company objectives?

1.Whether they has established the internal communication regarding


Internal rejection status & action plan, Productivity, Safety, Customer dissatifactions, Process
audit observations and Product audit observations ?

Are they identified the training needs based on the competency requirements & is training plan
developed accordingly?
Do they have a training aids / materials each topic / skill wise & is it updated regularly?

Are they carried out the training as per the plan or not?

Page No. 78 of 123

Rev.No. 1

Auditee
S. No.

EHS
TS Clause
Clause
Ref.
Ref.

Training & Development

Auditor

Title

IMS - IQA AUDIT CHECK LIST


Date
Department
What to look for

21

6.2.2.2

Do they have sufficient training records such as attendance sheet, class room / theoretical test
questionnaires & evaluation sheet?

22

6.2.2.2

Do they have defined qualification criteria for each skill & are they updated the skill matrix
accordingly?

23

6.2.2.2

Are they carried out the operator observation after training to evaluate the effectiveness of
training program & is it includes re-training?

Form No. F/MR/06

Page No. 79 of 123

Result

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

6.3.2

25

6.3.2

26

6.3.2

27

6.4.2

28

4.4.6

29

4.4.6

30

4.4.6

31

4.4.6

Form No. F/MR/06

Contingency

24

Title

What to look for

Result

Whether they has established the contingency plan for the Key equipments & Production tools,
Manpower shortage & Power failure ?
Are they defined the critical spare list? & Is it effective?
Are they monitored & maintained the critical spare list & availablity?

5S

EHS
TS Clause
Clause
Ref.
Ref.

Are they following & maintained the work place environment based on 3C & 5S concepts?

Whether they have established the OCP for smooth functioning of the EHS process?
Operational Control

S. No.

Is Operational control effective to control situations where their absence could lead to deviations
from the EHS policy and the objectives?
Whether the OCP's are derived from EHS risk assesment study & is it linked?
Is it accessible for use at work station?
Is activity performing by the personnel effectively adhered to OCP &
Are PPEs effectively used, wherever required?

Page No. 80 of 123

Rev.No. 1

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Auditor

Date

Auditee

Department

S. No.

EHS
TS Clause
Clause
Ref.
Ref.

Title

What to look for

7.5.1.4

4.4.6

Whether they have defined mechanism for carrying out Break down & Preventive maintenance?

33

7.5.1.4

4.4.6

Do they have a plan for preventive maintenance & are they carried out the PM as per plan or
not?

34

7.5.1.4

4.4.6

Are they maintained machines in good condition & is it consistent to produce good quality
products? (Check for oil / water / air leakages)

35

7.5.1.4

4.4.6

36

7.5.1.4

4.4.6

37

7.5.1.4

4.4.6

38

7.5.1.4

4.4.6

Are they maintained machine / equipment history card & is it updated regularly?

39

7.5.1.4

4.4.6

Is predictive maintenance method utilized to continually improve the effectiveness and efficiency
of the production equipment?

40

7.5.1.5

Whether they identified defined Identification & storage mechanism of production tools?

41

7.5.1.5

Are they stored the production tools as per the defined storage mechanaism & is it identifiable
easily?

42

7.5.1.5

ment of Production Tooling

Form No. F/MR/06

Control of machineries

32

Result

Are they carrying out the machine capability study for important characteristics and process
parameters & is it capable?
Are they installed any Poka yoke system to prevent / detect the failure in station? (Pls specify
the details)
Whether they have a defined mechanism to verify the functioning of Poka Yoke & are they
followed accordingly?

Whether they has established a mechanism for maintenance mould ?

Page No. 81 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Date

Auditee
S. No.

EHS
TS Clause
Clause
Ref.
Ref.

43

7.5.1.5

44

7.5.1.5

45

7.5.1.5

46

7.5.1.5

Form No. F/MR/06

Management of Production Tooling

Auditor

Title

Department
What to look for

Result

Do they have Mould history card & updated regularly?


Whether they have Preventive Maintenance plan for procduction tools?
Do they have a checklist for preventive Maintenance of tools & is it adequate?
Are they carried out the PM as per schedule? Do they have sufficient records?

Page No. 82 of 123

Rev.No. 1

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Auditor

Date

Auditee

Department

47

7.5.4

48

7.5.4

49

7.6.2

50

7.6.2

51

7.6.2

52

7.6.2

53

7.6.3.2

Form No. F/MR/06

Title

Customer
property

EHS
TS Clause
Clause
Ref.
Ref.

Calibration of monitoring equipments

S. No.

What to look for

Result

Do they have a list of customer property?

Is all customer proprties are identified permeantly & is it legible & Identifiable easily?

Whether they have defined mechanism for carrying out calibration and is it covered,
a) All the monitoring & measuring Instruments / equipments?
b) Calibration frequency (based on what)?
c) Method of calibration, environment condition & qualification of personnel ? (for In-house
calibration)
d) Acceptance criteria?
e) Correction in case of out of tolerance situation?
Do they have any defined unique identification methods to identify,
a) Identification No.
b) calibration status?
c) Validity of calibration?
D) MMD does not require calibration?
Do they have a plan for calibration & are they calibrated the MMD as per plan or not?

Do they have sufficient records of calibration & is it verified before release of instruments for
usage?

Is your calibration lab accredited to or meet the intent of ISO/IEC 17025 or national equivalent?

Page No. 83 of 123

Rev.No. 1

Calibration of monitorin

Auditor
Auditee
S. No.

54

Form No. F/MR/06

EHS
TS Clause
Clause
Ref.
Ref.
7.6.3.1

Title

IMS - IQA AUDIT CHECK LIST


Date
Department
What to look for

Result

Do they have lab scope of calibration lab, Master instruments calibration certificates to prove the
traceability to international or national standards?

Page No. 84 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

55

8.2.3

56

8.2.3

57

8.2.3

58

8.5.1.1

59

8.5.2 &
8.5.3

60

8.5.2 &
8.5.3

Title
Continual Monitoring and Measurement
Improvement
of Process.

EHS
TS Clause
Clause
Ref.
Ref.

Corrective & Preventive action

S. No.

What to look for

Result

Whether they has established the process measures such as MTBF, MTTR, No. of Break downs
& Machine availability % ?

Are they monitoring the process measures periodically?

Is all the process measures are under controlled?


If not are they developed the action plan to improve further?
Whether they has identified the areas for continual improvements?
No of Improvements
No of Kaizens done.
No of Environmental Management Programs

Whether they has initiated the corrective action for the non conformities observed during?
1) Negative Trends of the Process Measures
2) Not able to achieve the established targets
3) Internal NCRs raised from the interrelated departments
4) IQA NCRs
5) External Audit Findings
Are they carrying out the detailed cause analysis, corrective & preventive actions for the key
failures?

Any other observations, if any (Use additional sheet, if required)

Form No. F/MR/06

Page No. 85 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

EHS
TS Clause
Clause
Ref.
Ref.

Title

What to look for

Result

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor NonConformity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

Page No. 86 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 87 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 88 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 89 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 90 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 91 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 92 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 93 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 94 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 95 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Form No. F/MR/06

(Mould & Machine)

Page No. 96 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

Ref.

EHS
Clause
Ref.

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

Unintended use of obsolete documents.

4.2.4

4.5.4

Whether they have established the control of Records?

4.2.4

4.5.4

4.2.4

4.5.4

4.2.4

4.5.4

5.5.1

4.4.1

10

5.5.1

4.4.1

Form No. F/MR/06

Title

What to look for

Result

RecordControl

Document Control

Whether they have established the control of Documents?

Latest Revision of Documents available at point of use.

Legible and Readily identifiable.

Records are Legible and Readily Available

Storage method & retention of records?

Latest Revision of formats available at point of use.


Responsibility &
Authority

TS

S. No. Clause

Whether Responsibility & Authority of they established and known to the personnel?

Is there KRA assigned for all personnel & is it linked with company objectives?

Page No. 97 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

11

7.2.1

12

7.2.1

13

7.2.2

14

7.2.3

15

8.2.1

16

8.2.1

Form No. F/MR/06

Title

Customer satisfaction

Ref.

EHS
Clause
Ref.

Review of
Customer
Determination of
requirements
communicati
requirements related to
related to the
on
the product
product

TS

S. No. Clause

What to look for

Result

Does the organization determine customer requirements, including the delivery and postdelivery activities? (such as warranty claims collection, analyze)

Are customer specific requirements on management system received, reviewed & defined?

Are they reviewed the requirements related to the product prior to the organization's
commitment to supply a product to the customer? (such as documented as well as verbal
requirements)

How are the information related to products, enquiries, contracts/orders / amendments,


customer feedback including complaints communicated to customers?

Does the Organization conduct customer satisfaction survey (by internal data & getting
feedback from customer at a defined frequency?

Do they have sufficien records & maintained properly?

Page No. 98 of 123

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IMS - IQA AUDIT CHECK LIST


Auditee

Department
TS

S. No. Clause
Ref.

17

18

8.2.3

8.5.2 &
8.5.3

EHS
Clause
Ref.

Title

Monitoring and
Measurement of
Process

Date

Corrective &
Preventive action

Auditor

What to look for

Result

Whether they has established the process measures?


Sale value projection vs Actual
Trend on spare capacity
Customer satisfaction score (by using Internal data)
Customer satisfaction score ( by getting feedback from Customer)
No.of customers rated as Excellent

Whether they has initiated the corrective action for the non conformities observed in theys?
1) Negative Trends of the Process Measures
2) Not able to achieve the established targets
3) Internal NCRs raised from the interrelated departments
4) IQA NCRs
5) External Audit Findings

Any other observations, if any (Use additional sheet, if required)

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor NonConformity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

Page No. 99 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 100 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 101 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 102 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

Ref.

EHS
Clause
Ref.

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.4

4.5.4

Whether they have established the control of Records?

4.2.4

4.5.4

Records are Legible and Readily Available

4.2.4

4.5.4

CSR

4.2.4

4.5.4

10

5.5.1

4.4.1

11

5.5.1

4.4.1

12

5.5.3

13

6.3.2

14

4.4.6

15

4.4.6

16

4.4.6

17

4.4.6

Form No. F/MR/06

Record Control

Document Control

Title

What to look for

Result

Objective Evidence

Whether they have established the control of Documents?


Latest Revision of Documents available at point of use.
Legible and Readily identifiable.
Unintended use of obsolete documents.

Storage method & retention of records?


Are they retained the"D" / Safety / Traceability related records for 15 years?

Internal
Responsibility &
Contingency Communicat
Authority
ion

Latest Revision of formats available at point of use.


Whether Responsibility & Authority of they established and known to the personnel?

Is there KRA assigned for all personnel & is it linked with company objectives?

Whether they has established the internal communication regarding internal rejection, Testing
results, Product development status ?

Whether they has established the contingency plan for the Equipments in the organization ?

Whether they have established the OCP for smooth functioning of the EHS process?
Operational Control

TS

S. No. Clause

Is Operational control effective to control situations where their absence could lead to deviations
from the EHS policy and the objectives?
Whether the OCP's are derived from EHS risk assesment study & is it linked?
Is it accessible for use at work station?
Is activity performing by the personnel effectively adhered to OCP &
Are PPEs effectively used, wherever required?

Page No. 103 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

Ref.

EHS
Clause
Ref.

18

7.1

Whether they have guide line for APQP process &


Do they an APQP tracking mechanism in place?

19

7.1

Are they scheduled & conducted the mile stone review meeting to communicate launch status,
open issues to top management & sufficient records available or not?

20

7.3.4.1

21

7.1

22

CSR

Do they have effective communication matrix for the sharing or feedback to design reviews?

23

7.1

Do they have a mechanism for product and manufacturing process approval procedure
recognized by the customer ?

24

7.1.4

Do they have a guideline to manage the changes (Process / Product change)?

25

7.1.4

Do they have defined check list for manage and track the changes?

26

CSR

Are they conducted the feasibility & risk analysis along with CFT before initiating the changes?

27

7.1.4

28

7.1.4

29

7.1.4

Do they have a defined criteria for Internal / External PSW & Is it followed accordingly?

30

7.1.4

Is effective date of implementation recorded & is it communicated to customer?

31

7.2.2.2

Form No. F/MR/06

Change control:

Quality Planning

Title

MFG.
Feasibilit
y

TS

S. No. Clause

What to look for

Result

Objective Evidence

Is phase wise quality targets through out APQP process defined & being monitored & analyzed?
Are the results of such reviews reported in Management review for progress on design & any
constraints of resources?
Are they considering experience from previous developments / projects & Lessons learned from
existing serial production ?
(i.e.. TGR / TGW)

Do they have a list of changes happened & is it updated regularly?

Are they monitored the progress of changes & is it reviewed periodically?

Are they carried out manufacturing feasibility study , risk analysis for the proposed product ?

Page No. 104 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

Ref.

EHS
Clause
Ref.

32

7.3.1.1 &
7.2.1.1

33

7.3.5 &
7.3.6

34

8.1.1

Title
Design & dev. Multidisciplin
Statistical
-Verification &
ary
study
Validation
approach

TS

S. No. Clause

What to look for

Result

Objective Evidence

Are they using Multi disciplinary approach to prepare for product realisation , Identifying the
special characterstics, Develop and review of FMEA's & While identifying actions to reduce
potential risks ?

Are they performing design and development verification & Validation?


(Trial feed Back report, Trial reports)

Whether the organisation has determined a appropriate statistical tools at the time of APQP?

Any other observations, if any (Use additional sheet, if required)

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor NonConformity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

Page No. 105 of 123

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IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.4

4.5.4

4.2.4

4.5.4

4.2.4

4.5.4

4.3.1

4.3.1

4.3.2

10

4.3.2

Form No. F/MR/06

Title
Document Control

EHS
Clause
Ref.

RecordControl

TS
Clause
Ref.

Legal and
Hazard identification
other
& Risk assesment
requirements

S. No.

What to look for

Result

Latest Revision of Documents available at point of use.


Legible and Readily identifiable.
Unintended use of obsolete documents.
Records are Legible and Readily Available

Storage method & retention of records?

Latest Revision of formats available at point of use.


Are aspects/impacts & hazards/risks identified and Significant study conducted as per the rating
guidelines?
Are study reports reviewed and updated for
-After implementation of Objectives (Management Program)
-After occurrence of any accident / emergency
Do they have legal register?
Is all applicable legal & other requirements are addressed

Page No. 106 of 123

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IMS - IQA AUDIT CHECK LIST


Date

Auditee

Department
TS
Clause
Ref.

EHS
Clause
Ref.

Title

11

4.3.3

12

5.5.1

4.4.1

13

5.5.1

4.4.1

14

5.5.3

4.4.3

15

4.4.3

16

4.4.3

17

4.4.3

18

4.4.6

Internal
Communicat
ion
Participation & Consultation

What to look for

Result

Is EHS Management Programs made for all EHS objectives and is it implemented effectively?

Whether Responsibility & Authority of they established and known to the personnel?

Is there KRA assigned for all personnel & is it linked with company objectives?

1.Whether the department has established the internal communication regarding Training
programs, General Instructions & Process Performance of the department. ?

Are employees participated & consulted for development & review of EHS Policy, Objectives,
Risk Assessment and further introduction of facilities, infrastructure, system etc

Is there any system that is implemented for internal and external communications to and from
interested parties?

Is analysis done for the interested partys complaints?

Whether they have established the OCP for smooth functioning of the EHS process?
nal Control

Form No. F/MR/06

Responsibility &
Authority

S. No.

Objectives
& Target

Auditor

Page No. 107 of 123

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Auditor

Date

Auditee

Department

19

4.4.6

20

4.4.6

21

4.4.6

22

4.4.7

23

4.4.7

24

6.2.1

4.4.2

25

6.2.1

4.4.2

26

6.2.2.2

4.4.2

27

6.2.2.2

4.4.2

28

6.2.2.2

4.4.2

Form No. F/MR/06

Title
Operational Control

EHS
Clause
Ref.

What to look for

Result

Is Operational control effective to control situations where their absence could lead to deviations
from the EHS policy and the objectives?
Whether the OCP's are derived from EHS risk assesment study & is it linked?
Is it accessible for use at work station?
Is activity performing by the personnel effectively adhered to OCP &
Are PPEs effectively used, wherever required?

Emergency
Prepardness &
response

TS
Clause
Ref.

Is Emergency Preparedness procedure established for all emergency situations and


communicated to all concern?
Is periodical mock drill on emergency preparedness conducted and records maintained?
Do they have a defined guideline for training to ensures that competent personnel performing
work affecting product quality & Including EHS related skills?

Training & Development

S. No.

Do they have a competent personnel performing significant activitites related to EHS interms of
education, training, skills and experience?
Are they carried out the training as per the plan or not?
Do they have sufficient training records such as attendance sheet, class room / theoretical test
questionnaires & evaluation sheet?
Do they have defined qualification criteria for each skill & are they updated the skill matrix
accordingly?

Page No. 108 of 123

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Auditor

Date

Auditee

Department

29

6.2.2.4

30

6.2.2.4

31

6.2.2.4

32

8.2.3

4.5.1

33

8.2.3

4.5.1

34

8.2.3

4.5.1

35

8.2.3

4.5.1

36

8.5.1.1

Form No. F/MR/06

Title
Employee motivation and
empowerment

EHS
Clause
Ref.

Monitoring and Measurement of Process.

TS
Clause
Ref.

Continual
Improvement

S. No.

What to look for

Result

Does organization have a process to motivate employees to achieve objectives, to make


continual improvements, and to create an environment to promote innovation?

Are they carry out periodical suggestion committee meeting?

Are they monitoring the progress status of suggestions & recognization given for that?

Whether they has established the process measures such as attrition rate, Absentism rate,
employee satisfaction index & etc. ?

Are key characteristics of EHS performance defined, monitored & measured and related reports
maintained?

Are they monitoring the process measures periodically?


Is all the process measures are under controlled?
If not are they developed the action plan to improve further?
Whether they has identified the areas for continual improvements?
No of Improvements
No of Kaizens done.
No of Environmental Management Programs

Page No. 109 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

Title

What to look for

Result

Any other observations, if any (Use additional sheet, if required)

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor NonConformity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

Page No. 110 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 111 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 112 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 113 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 114 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 115 of 123

Rev.No. 1

IMS - IQA AUDIT CHECK LIST


Date

Auditee

Department
TS
Clause
Ref.

EHS
Clause
Ref.

Title

4.1

4.1

Doc.Requi
Quality Manual
rements

S. No.

General

Auditor

What to look for


Is IMS system established, Documented, Implemented, and Maintained and Continually
improved in accordance with ISO/TS 16949:2009, ISO 14001:2009 and OHSAS 18001:2007
Standards?
Whether they established the Quality Management Manual ?
Whether the Quality Manual has included
1) Scope of certification
2) Justification for any exclusions of TS Clause
3) Documented procedures for all departments
4) Description of the interaction between the processes of the QSM.

4.2.2

4.4.4

4.2.1

4.4.4

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

4.2.3

4.4.5

Unintended use of obsolete documents.

4.2.4

4.5.4

Whether they have established the control of Records?

4.2.4

4.5.4

10

4.2.4

4.5.4

Form No. F/MR/06

Result

Whether the organization have documented procedures for all processes /departments?

RecordControl

Document Control

Whether they have established the control of Documents?


Latest Revision of Documents available at point of use.
Legible and Readily identifiable.

Records are Legible and Readily Available


Storage method & retention of records?

Page No. 116 of 123

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IMS - IQA AUDIT CHECK LIST


Date

TS
Clause
Ref.

EHS
Clause
Ref.

11

4.2.4

4.5.4

12

5.3

4.2

13

5.4.1

4.3.3

14

5.4.1.1

Form No. F/MR/06

Title

Department
What to look for

Result

Latest Revision of formats available at point of use.


Quality Policy

S. No.

Quality & EHS


Objectives

Auditee

RecordControl

Auditor

Whether the top management has ensured that the Quality policy?
a) is appropriate to the purpose of the organisation?
b) is providing a frame work for establishing and reviewing quality objectives ?
c) is reviewed for continuing suitability
Whether IMS Objectives & Targets Of they has been established based on qulaity policy?
Whether the Quality objectives and targets established are SMART ?

Whether Quality Objectives & Targets have been Monitored and achieved?

Page No. 117 of 123

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Date

Auditee

Department
TS
Clause
Ref.

EHS
Clause
Ref.

Title

17

5.5.3

18

5.6

4.6

19

5.6

4.6

20

5.6

4.6

21

5.6

4.6

22

8.2.2

4.5.5

Is procedure established and documented for conducting internal audits on QMS?

23

8.2.2

4.5.5

Is internal audit planned / scheduled and communicated to relevant functions?

24

8.2.2

4.5.5

25

8.2.2

4.5.5

Are internal auditors qualified to perform audit and is independent?

26

8.2.2

4.5.5

Are corrective actions identified and implemented with in the target date for the nonconformities, if any?

Form No. F/MR/06

Management Review

S. No.

Internal
Communicat
ion

Auditor

What to look for

Result

1.Whether they has established the internal communication regarding IMS Policy, IMS
Objectives and targets, Internal Quality Audits , Audit observations , Non conformities observed
in the organisation , any changes in International Standards ?
Is management review meeting conducted as per the planned intervals & sufficient records
available?
Are follow-up actions from previous management review included & tracked for the progress?

Is management review covers all inputs as defined in IMS Manual / procedure?

Internal Audit

Is management review minutes maintained? Are outputs from management review identified?

Is internal audit conducted as per the plan and reports (Filled audit checklists) maintained?

Page No. 118 of 123

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Auditor

Date

Auditee

Department

S. No.

TS
Clause
Ref.

EHS
Clause
Ref.

Title

What to look for

Result

Any other observations, if any (Use additional sheet, if required)

Legands : O+ : Positive Point, C : Conformance, OI : Opportunities for Improvement, MIN.NC: Minor NonConformity, MAJ.NC : Major Non Conformity

Form No. F/MR/06

Page No. 119 of 123

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QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 120 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 121 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 122 of 123

Rev.No. 1

QA AUDIT CHECK LIST

Objective Evidence

Form No. F/MR/06

Page No. 123 of 123

Rev.No. 1

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