QUALITY SYSTEM AUDIT CHECK LIST

(Internal Audit)
PROCESS:- Sales & Marketing DATED: -

CRITICAL COMPLIA
S. WEIGHTAGE
CHECKS ITY NCE OBSERVATION
NO. (C)=(a) x (b)
(a) (b)

1 Awareness on input, output & effectiveness 3

criteria of process.

2 Are quality manual, QSP & document of 2

effectiveness criteria available?

3 Are the latest documents available? 3

4 Is quality policy understood by the personnel? 2

5 Does the process review the requirements 3

related to the product?

6 Does the process review the requirements 3

before acceptance/ commitment to supply?

7 Are relevant documents amended & relevant 3

personnel made aware when product
requirements are changed?

8 Does the process determine & implement 3

effective arrangements for communication
with customer?

9 Are satisfaction of customers being 3

monitored, analyzed & evidence available?

10 Are corrective & preventive actions identified 3

& effectively implemented for non
conformities related to the system?

11 Are all effectiveness criteria monitored as per 3

the system and records available?

Total å 31

SYSTEM EFFECTIVESS % = å(c) x 100 =

å(a)x3
NOTE:
-
CRITICALITY:-

1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-
1 - No compliance - Major Non-conformity
2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity
4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18:01
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Material Purchasing DATED: -
CRITICALIT COMPLIANC WEIGHTA
S.
CHECKS Y E GE OBSERVATION
NO.
(a) (b) (C)=(a) x (b)
1 Awareness on input, output & effectiveness 3
criteria of process.
2 Are quality manual, QSP & document of 2
effectiveness criteria available?.
3 Are the latest documents available?. 3
4 Is quality policy understood by the personnel?. 2

5 Are suppliers evaluated and selected based on 3

their ability to meet quality system and quality
assurance requirements?.

6 Are records of the results of evaluation and 3

necessary actions available?.
7 Are the specifications of purchasing products 3
mentioned in purchasing documents?.
8 Are the intended verification arrangements, 3
methods of product release stated in purchasing
information where the organization or its
customers intends to perform verification at
supplier's end?.

9 Are corrective & preventive actions identified & 3

effectively implemented for non conformities
related to the system?.

10 Are all effectiveness criteria monitored as per 3

the system and records available?.
Total å 28

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:
CRITICALITY:-
1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name &

Signature
F:GEN:18
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Material Storage DATED: -
S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
1 Awareness on input, output & 3
effectiveness criteria of process.
2 Are quality manual, QSP & document of 2
effectiveness criteria available?.
3 Are the latest documents available?. 3
4 Is quality policy understood by the 2
personnel?.
5 Are the storage areas appropriate for 3
preventing damage of the product?.
6 Are the storage materials properly 2
identified?.
7 Are corrective & preventive actions 3
identified & effectively implemented for
non conformities related to the system?.

8 Are all effectiveness criteria monitored as 3

per the system and records available?.
9 Does the organization determine, provide 3
and maintain the infrastructure needed to
achieve conformity to product
requirements?.

Total å 24

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:

CRITICALITY:-
1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Production DATED: -
S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
1 Awareness on input, output & effectiveness 3
criteria of process.
2 Are quality manual, QSP & document of 2
effectiveness criteria available?.
3 Are the latest documents available?. 3
4 Is quality policy understood by the personnel?. 2
5 Do employees perform operations as per 2
documented instructions?.
6 Is product identified, where appropriate, at all 3
production stages?.
7 Does the process plan and carry out production 3
under controlled conditions?.
8 Are corrective & preventive actions identified & 3
effectively implemented for non conformities
related to the system?.
9 Are all effectiveness criteria monitored as per 3
the system and records available?.
10 Does the organization determine, provide and 3
maintain the infrastructure / work environment
needed to achieve conformity to product
requirements?.

11 Is the product monitored and measured to verify 2

that product requirements have been met in
stages?.
12 Are the personnel performing work affecting 3
product quality competent on the basis of
appropriate education, training, skills and
experience?.

Total å 32

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:
CRITICALITY:-

1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Design & Development DATED: -
S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
1 Awareness on input, output & effectiveness 3
criteria of process.

2 Are quality manual & document of effectiveness 2

criteria available?.

3 Are the latest documents available?. 3

4 Is quality policy understood by the personnel?. 2
5 Have development plans for each project been 3
established and responsibility assigned?

6 Are the inputs relating to product requirements 3

determined and records maintained?

7 Are the outputs of development provided in a form 3

that enables verification against development input
and are approved prior to release?

8 Are systematic reviews performed, at suitable 3

stages, in accordance with planned arrangements &
records maintained?

9 Is the verification performed in accordance with 3

planned arrangements to ensure that the outputs
have met the input requirements & record
maintained?

10 Is the validation performed in accordance with 3

planned arrangements to ensure that the resulting
product is capable of meeting the requirements for
the specified application or intended use?

11 Is the validation complete, wherever practicable 3

prior to the delivery or implementation of the
product and record maintained?

12 Are changes identified and record maintained? 3

13 Are changes reviewed, verified and validated, as 3
appropriate, and approved before implementation?

14 Does the review of changes include evaluation of 3

the effect of the changes on constituent parts and
product already maintained?

15 Are records of the results of the review of changes 3

and any necessary actions maintained?

F:GEN:18 Contd. 02
 S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
16 Are corrective & preventive actions identified & 3
effectively implemented for non conformities
related to the system?.

17 Are all effectiveness criteria monitored as per the 3

system and records available?.

Total å 49

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:
CRITICALITY:-
1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Product Verification (QA & Lab.) DATED: -
S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
1 Awareness on input, output & effectiveness 3
criteria of process.
2 Are quality manual, QSP, WI, QP & document of 2
effectiveness criteria available?.
3 Are the latest documents available?. 3
4 Is quality policy understood by the personnel?. 2
5 Is purchased material controlled and verified as per 3
system prior to release for production?.
6 Are the test certificates from suppliers received 3
and verified as per the requirement?.
7 Does the process inspect and test product as 3
required by the documented procedures?.
8 Does the process conduct final inspection and 3
testing in accordance with document procedures &
customer requirement?.
9 Does the process maintain adequate records of all 3
inspections and tests?.
10 Does the organization determine, provide and 3
maintain the infrastructure needed to achieve
conformity to product requirements?.
11 Does the process / organization determine the 3
monitoring & measurement to be undertaken and
the monitoring and measuring devices needed to
provide evidence of conformity of product to
determine requirements?.

12 Are all measuring & testing equipments/ 3

instruments calibrated in defined frequency where
the product quality can be affected?.
13 Is calibration status available on the measuring & 2
testing equipments / instruments?.
14 Are all measuring & testing equipments/ 3
instruments calibrated in defined frequency where
the product quality can be affected?.
15 Are records of calibration available? 3
16 Is inspection & test status suitably identified 3
throughout the production process?.
17 Are corrective & preventive actions identified & 3
effectively implemented for non conformities
related to the system?.
F:GEN:18 Contd. 02
 S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
18 Are all effectiveness criteria monitored as per the 3
system and records available?.
19 Are there clear responsibilities for review and 3
disposition of non conforming and suspect
product?.

20 Are non conforming products reviewed according 3

to the defined procedures?.
21 Are the personnel performing work affecting 3
product quality competent on the basis of
appropriate education, training, skills and
experience?.

22 Does the organization identify, verify, protect and 3

safeguard customer property provided for use or
incorporation in the product?.

23 Does the organization reports to the customer and 3

maintains record in case of customer property is
lost, damaged or otherwise found to be unsuitable
for use?.

Total å 66

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:
CRITICALITY:-
1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Maintenance DATED: -
S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
1 Awareness on input, output & 3
effectiveness criteria of process.
2 Are quality manual, QSP & document of 2
effectiveness criteria available?.
3 Are the latest documents available?. 3
4 Is quality policy understood by the 2
personnel?.
5 Do employees perform work as per 2
documented instructions?
6 Is appropriate maintenance conducted at 2
the prescribed frequencies for the
machineries?
7 Is there maintenance activities available 3
as per system?
8 Are records of maintenance activities 2
available as per system?
9 Are corrective & preventive actions 3
identified & effectively implemented for
non conformities related to the system?.
10 Are all effectiveness criteria monitored as 3
per the system and records available?.
Total å 25

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:
CRITICALITY:-
1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Training DATED: -
S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
1 Awareness on input, output & 3
effectiveness criteria of process.
2 Are quality manual & document of 2
effectiveness criteria available?.
3 Are the latest documents available?. 3
4 Is quality policy understood by the 2
personnel?.
5 Are the training needs for all personnel 3
performing activities affecting quality
identified?
6 Is training activity carried out as planned? 3
7 Is training effectiveness evaluated? 3
8 Are records of education, training, skills 3
and experience & effectiveness of
training maintained?
9 Are internal customer satisfaction 3
evaluated as per the system?
10 Are corrective & preventive actions 3
identified & effectively implemented for
non conformities related to the system?.
11 Are all effectiveness criteria monitored as 3
per the system and records available?.
Total å 31

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:
CRITICALITY:-
1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Internal Audit DATED: -
S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
1 Awareness on input, output & 3
effectiveness criteria of process.
2 Is the document of effectiveness criteria 2
available?
3 Is the documented procedure available? 3

4 Are the latest documents available?. 3

5 Dose the organization carry out internal 3

audit as planned?
6 Are personnel conducting the audit 2
independent of the function being
audited?
7 Are the audits scheduled on the basis of 2
the status and importance of the activity?
8 Are the audit results documented and 3
brought to the attention of the responsible
person?

9 Are corrective actions timely recorded 3

and evaluated for effectiveness?
10 Is trained internal auditors used? 3

11 Are all effectiveness criteria monitored as 3

per the system and records available?.
Total å 30

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:
CRITICALITY:-

1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18
 QUALITY SYSTEM AUDIT CHECK LIST
(Internal Audit)
PROCESS:- Management Review Meeting DATED: -
S. CHECKS CRITICALITY COMPLIANCE ( b ) WEIGHTAGE
NO. (a) 1 2 3 4 (C)=(a) x (b)
1 Awareness on input, output & 3
effectiveness criteria of process.

2 Are quality manual & document of 2

effectiveness criteria available?.

3 Are the latest documents available?. 3

4 Does the management review the QMS at 3
planned intervals, to ensure its continuing
suitability, adequacy and effectiveness?

5 Are records of reviews maintained? 3

6 Is there a clearly identified management 3
representative with authority and
responsibility to ensure the system
compliance?

7 Are the adequated informations discussed 3

in MRM as inputs?

11 Are all effectiveness criteria monitored as 3

per the system and records available?.

Total å 23

SYSTEM EFFECTIVESS % = å ( c ) x 100 =

å(a)x3
NOTE:
CRITICALITY:-
1 - Very Low, 2 - Moderate, 3 - Very High

COMPLIANCE:-

1 - No compliance - Major Non-conformity

2 - Sketchy compliance. Not effective - Major Non-conformity
3 - Single observed lapse / discipline not observed - Minor Non-conformity

4 - Very high compliance - Observation may be given. Name & Signature

F:GEN:18