Internal Audit Checklist - QC

Auditee- Date-

Auditor- Time-

Sr. No Clause Question for Internal Audit Check points Audit Observations Remarks

1. List down all aplicable business processes

0 2. check targets of KPI are achieved
3. Last AUDIT NC are clossed ?

1. is production stopage authority defined ? And those persons

1 5.3.2 1. Roles and responsibility defined ?
are available in all shifts ?

1. Does FMEA exist ?

2 6.1.2.1 2. Does FMEA is based on customer complaints/ Field 1. FMEA and process owner interactions
failures ?

1. Appropriate instruments as per control plan,

7.1.5 1. Are the proper measuring and monitoring devices are
3 2. Least count rule applicability - Tolarance to
7.1.5.1 available at shop floor ? Are they suitable for its purpose ?
least count ration must be more than 10

1. MSA Plan
2. All instruments of control plan must be
covered
1. Does MSA plan is available ? And MSA is conducted as per
4 7.1.5.1.1 3. All MSA conducted as per plan
plan ?
4. Results of MSA are valid and approved
5. If results of MSA are not OK, what actions
are taken

1. Skill Requirements/ Job discriptions

2. SOPs
5 7.1.6 1. Is the organizational Knowledge is defined and maintained ?
3. On the job trainings
4. Planned trainings

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 Internal Audit Checklist - QC

Auditee- Date-

Auditor- Time-

Sr. No Clause Question for Internal Audit Check points Audit Observations Remarks

1. Does the production requirements are made clear through

product requirements, Acceptance criteria, resources for
processes, controls at processes ? 1. Job card/ Job specification
6 8.1 2. Does the SOPs/Control plans and neccesory information is 2. Control Plan/SOP/ Charts/Tables
available for production ? 3. All logs of production/Quality
3. Are the records are maintained ? does conformity of product
is recorded ?

1. If asked by customer, Does Organization plans additional

7 8.3.4.2 1. Addional information asked by Customer.
validation activities ?

1. Does the control on incoming products are established to

1. Incoming inspection process, Plan,
ensure the final product is manufactured as per requirement ?
8 8.4 Inspection methods
Does it includes all raw materails, materail that affects product
2. Calibnration report verifications
quality and calibration reports ?

1. Does the proper control is established for outsourced/ bought

9 8.4.2 1. Method of control on Boughtout materail
out products ?

1. Does the documented process is established to define the

1. Documented process and Evidance of
10 8.4.2.1 type and extent of control on outsourced and boughtout
following the process
products ?

1. Does the guideline documents like work instructions/ SOP

1. Availibility of work instruction, Take operator
11 8.5.1.2 are available at work locations ? Does operator understands
interview for the work instruction understanding
the same ?

1. Does the process maintions verification after long 1. Verification of first article after long
12 8.5.1.4
shutdown ? If yes, verification is done for the process ? shutdown- Sunday/ Diwali holidays.

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 Internal Audit Checklist - QC

Auditee- Date-

Auditor- Time-

Sr. No Clause Question for Internal Audit Check points Audit Observations Remarks

1. Does the Identiifcation to materail laying in shop floor/Stores/

Finish goods is maintained ? 1. Identification of OK/NOK/Suspected parts
13 8.5.2 2. How the traciability of products is maintained ? 2. Traciability
3. Does the rejected products are treated as per defined 3. Handling of NC products
process of " Handling of non-conforming products "

1. Does the products are preserved in the way to protect it from

14 8.5.4 1. Storage conditions
mixing, damage, enviornmental impact ?

1. Does feedback system from customer to manufacturing is 1. How the customer feedback is transferred to
15 8.5.5.1
inplace ? concerns

1. Does all the products at all production and final inspection 1. IPQC checks
16 8.6
stages are released after found OK ? 2. FQC checks and their results

1. Does IPQC and Production checks confirms that product is

17 8.6.1 1. Control plan and applicable records
manufactured as per control plan ?

1. Does the process for layout inspection in place ? All the 1. Layout Inspection SOP
18 8.6.2 layout inspections are conducted as per plan and are the 2. Layout inspection Plan
records are maintained ? 3. Records of Layout inspection

1. Does the documented process for Incoming goods inspection

19 8.6.4 is in plce ? Does the process is followed and are records 1. IGQC Process and IGQC reports
maintained ?

1. Does IGQC conforms that goods meets statutory and

20 8.6.5 1. Evidance
regulatory requirements applicable to those products ?

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 Internal Audit Checklist - QC

Auditee- Date-

Auditor- Time-

Sr. No Clause Question for Internal Audit Check points Audit Observations Remarks

1 does acceptance criteria is defined ? Does criteria is ZERO

21 8.6.6 1. AQL sampling plan
for attribute defects ?

1. Process for Non conforming materail

1. Does the process for Non conforming products is defined ?
handling
Does the separate identification on product and separate area
2. Area for non conforming materail.
22 8.7.1 is identified for such products ?
3. separate area for non conforming materail
2. Does the Non conforming materail is avoided to mix up in
4. Identification on non-conforming products
good materail ?
5. Action on non--conforming products

1. Does the customer approval taken prior to dispatch if any

non conforming products need to be disptached to customer ?
23 8.7.1.1 1. Customer deviation
Does the same approval is taken if manufacturing defect
observed in production process for further processing ?

1. Does customer specific instructions for non conforming 1. Customer specific instructions for Non
24 8.7.1.2
products are identified and followed ? conforming products

1. Does the unidentified, suspect products are treated as non -

25 8.7.1.3 1. How shop flor treats the suspect product
conforming products ?

1. Does risk analysis is done prior to decision regarding

rework ? 1. Rework process
26 8.7.1.4 2. Does the documented process for rework is in place ? Does 2.Rework risk analysis
the process is followed ? 3. Inspection process
3. Does the reworked products undergo the 100 % inspection ?

1. Is the documented process for control of repaired products 1. Documented process for control of repaired
available ? Does the repaired products are undergone risk products
27 8.7.1.5 analysis before conducting repair on the product ? Does 2. Risk analysis for repaired products
customer approval is taken (If asked by customer) is obtained 3. Customer approval, if demanded by
before start of repair ? customer

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 Internal Audit Checklist - QC

Auditee- Date-

Auditor- Time-

Sr. No Clause Question for Internal Audit Check points Audit Observations Remarks

1. Does the process for informing customer, when non 1. Customer communication for defective
28 8.7.1.6 conforming products are shipped to customer is in place ? Does products disptached
any evidance of such incidance ? 2. Evidance if any

1. Does the documented process for non conforming product 1. Process of non conforming product
29 8.7.1.7
distribution in place ? disposition

1. Does the information regarding non conforming products and 1. Non conformities. Actions, deviations and
30 8.7.2
details are maintained as documented information ? authorizations

1. Does the performance indicators are set for processes ? Is

1. Data monitoring as per defined targets,
31 9.1.1 the analysis and evaluation done after monitoring and
Action plans and evaluations
measurement of processes ?

1. Does the process for customer satisfaction implemented ?

1. Process for customer satisfaction
32 9.1.2 2. Does the customer satisfaction index matches the target
2. Customer satisfaction servey results
defined by organization

1. Are the internal indicators for customer satisfaction defined 1. Customer return PPM, Field failures, Delivery
33 9.1.2.1
and monitored ? ratings

1. Is the appropriate data is analysed ?

2. Is the analysis used to evaluated the KPIs like customer 1. KPI defined,
34 9.1.3
satisfaction, Product conformity, effectiveness of actions, 2. KPI monitoring and actions
Performance of suppliers etc.

Are the action taken on KPIs prioritized based on customer

35 9.1.3.1 1. Prioritization of action on KPI
satisfaction and risk?

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 Internal Audit Checklist - QC

Auditee- Date-

Auditor- Time-

Sr. No Clause Question for Internal Audit Check points Audit Observations Remarks

1. Does the opportunities for improvements are identified and

36 10.1 1. Kaizens, Pokayokes, Projects
neccesory actions are taken ?

1. Does the documented process for handling non-conformity

1. Documented process
and corective preventive action in place ? Does process
37 10.2 2. CAPA and NC handling methods
explains about the how to handle the non conformity ? Does the
3. CAPA Evidances
process is followed ?

1. Does the documented process for problem solving is in place

1. Documented process
38 10.2.3 ? Does it explains about how to deal with Non conformities of
2. Evidance
different types ?

1. Does the customer complaint and field failure register is

39 10.2.6 maintained ? 1. Customer complaint register and analysis
2. Does the proper analysis is done for customer complaints ?

40 10.3 1. Does the continual improvement is evidant ? 1. Kaizens, Pokayokes, Projects

1. Does the Continual improvement process is documented and 1. Documented process of continual
41 10.3.1
followed ? improvement

Legends- 1) C- Conformance
2) NC- Non Conformity Auditee Sign- Auditor Sign-
3)O- Observation

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