Internal Audit Checklist for Quality Assurance & Control Department

S.N Requirements What to look for Assessor notes / Objective evidence

Verification of Purchased Product
1. Does the organization establish and implement  Incoming inspection plans.
the inspection or other activities necessary for
ensuring that purchased product meets
specified purchase requirements?
Incoming Product Quality
2. Does the organization have a process to  Incoming inspection
assure the quality of purchased product  Source inspection
utilizing one or more of the following methods:  2nd or 3rd party audits of supplier sites.
- receipt of, and evaluation of, statistical data  Independent evaluation of acceptability
by the organization? of product by a designated 3rd party.
- Receiving inspection and/or testing such as
sampling based on performance?
- Second or third party assessments or
audits of supplier sites, when coupled with
records of acceptable delivered product
quality?
- Part evaluation by a designated laboratory?
- Another method agreed with the customer
Identification and Traceability
3. Does the organization identify the product  Clear identification of work in-process;
status with respect to monitoring and finished goods and rejected goods
measurement requirements? and /or components
 Inspection records
Customer Property
4. Does the organization verify customer property  Verification System.
provided for use or incorporation into the
product?
Control of Monitoring and Measuring Devices
5. Has the organization determined the monitoring  Test equipment accuracy and precision
and measurement to be undertaken and the capability related to the required
monitoring and measuring devices needed to measurement.
provide evidence of conformity of product to
determined requirements?

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S.N Requirements
6. Has the organization established processes to
ensure that the monitoring and measurement
can be carried out and are carried out in a
manner that is consistent with the monitoring
and measurement requirements?
7. Where necessary to ensure valid results, are
the organization’s measuring equipment:
a) calibrate or verified at specified intervals, or
prior to use, against measurement
standards traceable to international or
national measurement standards?
b) Adjusted or re-adjusted as necessary?
c) Identified to enable the calibration status to
determined?
d) Safeguarded from adjustments that would
invalidate the measurement result?
e) Protected from damage and deterioration
during handling, maintenance and storage?
8. Does the organization assess and record the
validity of the previous measuring results when
the equipment is found not to conform to
requirements?
9. Does the organization take appropriate action
on the equipment that is found not conforming
to requirements and any product affected it?
10. Does the organization maintain records of the
results of calibration and verification ( 4.2.4 of
ISO 9001:2015)?
11. When the equipment is used in the monitoring
and measurement of specified requirements
has the organization confirm the ability of
computer software to satisfy the intended
application?
What to look for Assessor notes / Objective evidence
 Monitoring and measurement trails
during prototype builds
 Procedure address in organization’s
quality manual in accordance to ISO
9001:2015 (E).
 Test equipment inventory
 Certification for calibration masters and
their tractability to international national
recognized standard.
 Calibration results records.
 Method of control of calibration settings.
 Calibration status identification.
 Records of re-inspected product.
 Action taken on the equipment that are
found not conforming to requirements
and any product that w as affected by it
 Gage studies records
 Product labeling system
 Customer requirements.
 Labeling audit
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S.N Requirements What to look for Assessor notes / Objective evidence
12. Has the organization undertaken the  Test software/ comparative references
confirmation of software satisfying an intended verification.
application prior to initial use and reconfirmed
as necessary?

Measurement System Analysis

13. Does organization conduct statistical studies to  Measurement system analysis studies
analyze the variation present in the results of including Gage Repeatability &
each type of measurement and test equipment Reproducibility
system?
14. Does the organization conduct measurement  Measurement system analysis results.
system analysis for measurement system
referenced in the control plan?

15. Does the organization use measurement
system analytical methods and acceptance
criteria that conform to those in customer
requirements?
 Check methods against customer
measurement system analysis
requirements
 Customer approval records, for other
analytical methods used

Calibration Records
16. Does the organization’s records of the  Measurement equipment records
calibration activity for all gauges, include:  Original specification of measurement
a) Equipment identification, including the equipment.
measurement standard against which the
equipment is calibrated?
b) Revisions following engineering changes
c) any out of specification readings as
received for calibration / verification?
d) An assessment of the impact of out –of-
specification condition?
e) Statements of conformity to specification
after calibration / verification?
f) Notification to the customer is suspect
product or material has been shipped?

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S.N Requirements What to look for Assessor notes / Objective evidence
Internal Laboratory
17. Does the organization’s internal laboratory  Laboratory Scope -
facility have a defined scope that includes
capability to perform the required inspection,
test or calibration services?

18. Is the organization’s lab scope included in the  Organization’s quality manual as per
quality management system documentation ISO 9001:2015(E)
including:
- adequacy of the laboratory procedures?
- Qualifications of the laboratory personnel
conducting tests?
- Testing of the commodity?
- Performing these tests correctly, traceable
to the relevant process standards?
- Review of the related quality records?

External Laboratory
19. Do the external/ commercial/ independent  commercial Laboratory Accreditation NABL approved labs
laboratory facilities used for inspection, test or records
calibration services by the organization have a
defined laboratory scope that includes
capability to perform the required inspection,
test or calibration, and:
- be accredited to ISO/IEC 17025 or national
equivalent
- have evidence that the external laboratory
is acceptable to the customer?

Measurement, Analysis and Improvement

Identification of Statistical Tools
20. Does the organization determine the  Review of control plan.
appropriate statistical tools for the processes  Review of quality plan
during Advance Product Quality Planning  Plant tour
included in the control plan?

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S.N Requirements What to look for Assessor notes / Objective evidence
Manufacturing Process Audit
21. Does the organization audit each  Audit plans.
manufacturing process to determine its  Audit reports.
effectiveness?

Product Audit
22. Does the organization audit products at  Audit plan, process flow chart and Product rating
appropriate stages of production and delivery schedule
to verify conformance to all specified  Product audit procedure and reports
requirements at a defined frequency?

Internal Audit Plans

23. Does the organization increase its audit  Audit schedule of Product & Processes
frequency appropriately when internal /external  Appropriate prioritization
non-conformities or customer complaints
occur?
Internal Auditor Qualification
24. Are the organization’s internal auditors for  Compliance to customer requirements
product & manufacturing processes qualified
for conducting the audit?

25. Does the organization perform process studies  Preliminary process capability results.
on all new manufacturing processes to verify  Production control plan
process capability and to provide additional
input for process control?

26. Does the organization maintain manufacturing
process capability or performance as specified
by the customer part approval process
requirements?
27. Does the organization maintain records of
effective dates of process changes?
 Current Cpk/Ppk versus customer
approved Cpk/Ppk
 Existing reaction plan.
 Verifying the accuracy of Cpk /Cpk
calculations.
 Records of process change dates.

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S.N Requirements What to look for Assessor notes / Objective evidence

28. Does the organization monitor and measure  Control plans

the characteristics of the product to verify that  Inspection instructions
product requirements have been met?  Records

29. Does the organization monitor and measure  Control plans

the characteristics of the product at appropriate  Inspection instructions
stages of the product realization process in  Records.
accordance with the planned arrangements?

30. Does the organization maintain evidence of
product conformity with the acceptance
criteria?
31. Does the organization’s records on monitoring
and measurement of product indicate the
person (s) authorizing release of product?
 Inspection records that includes
acceptance criteria, inspector
performance the test, test status and
testing date.
 Inspection records that indicate the
person (s) authorizing release of
product.

32. Are the organization’s product release and  Release of product and service delivery
service delivery proceed only after all the after all planned arrangement is
planned arrangements have been satisfactorily satisfactorily completed.
completed, unless otherwise approved by a
relevant authority, and where applicable by the
customer?

Layout Inspection and Functional Testing

33. Does the organization perform a layout
inspection and a functional verification to
applicable customer engineering material and
performance standards for all products at a
sufficient frequency as specified in the control
plan?
34. Does the organization have layout inspection
and functional testing results available for
customer review?
 Layout inspection reports
 Control plan.
 Inspection records, that include
acceptance criteria, inspector
performing the test, test status and,
testing data.

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S.N Requirements
Control of Nonconforming Product
35. Does the organization ensure that product
which does not conform to product
requirements is identified and controlled to
prevent its unintended use or delivery?
36. Does the organization deal with nonconforming
product by one or more of the following ways:
a) by taking action to eliminate the detected
nonconformity?
b) By authorizing its use, release or
acceptance under concession by a relevant
authority and, where applicable, by the
customer?
c) By taking action to preclude its original
intended use or application?
37. Does the organization maintain records of the
nature of non-conformities and any subsequent
actions taken, including concessions ?
38. When nonconforming product is corrected,
does the organization re-verify to demonstrate
conformity to the requirements?
39. When nonconforming product is detected after
delivery or use has started, does the
organization take action appropriate to the
effects, or potential effects, of the
nonconformity?
40. Does the organization classify unidentified or
suspect status product as nonconforming
product?
What to look for Assessor notes / Objective evidence
 Follow one or more nonconforming
case and verify the flow (identification),
segregation, etc.)
 Obsolete products
 Follow one or more non-conforming
case and verify the visual identification
and segregation area.
 Records of concession.
 Records
 Instruction for re-qualifying corrected
nonconforming product.
 Follow one or more nonconforming
case and verify the flow (identification,
segregation, etc.)
 Follow one or more nonconforming
case and verify the flow (identification,
segregation, etc.).
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S.N Requirements What to look for Assessor notes / Objective evidence
Control of Reworked Product
41. Are the organization’s instructions for rework,  Rework instructions
including re-inspection requirements accessible
and utilized by the appropriate personnel?

Customer Information about Nonconforming Product

42. Does the organization inform the customers
promptly in the event that nonconforming
product has been shipped?
Customer Waiver
43. Does the organization obtain customer
concession or deviation permit prior to further
processing whenever the product or
manufacturing process is different from that
which is currently approved?
 Follow one or nonconforming case and
verify the flow (identification,
segregation, etc.)
 Procedure stated in quality manual.
 Follow one or more nonconforming
case and verify the flow (identification,
segregation, etc.)

44. Does the organization maintain a record of the  Record of concession with expiration
expiration date or quantity authorized by data.
customer concession or deviation permit?

45. Does the organization ensure compliance with  Inspection results

the original or superseding specification and
requirements when the authorization for
deviation expires?

46. Does the organization properly identify on each  Proper label/identification for material
shipping container material shipped on an shipped on authorization.
authorization?

47. Does the organization apply the customer  Process define in quality manual
waiver requirements for production product to
purchased product as well?

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S.N Requirements What to look for Assessor notes / Objective evidence
48. Does the organization agree with any product  Process define the quality manual.
concession requests from suppliers before
submission to the customer?

Analysis and Use of Data

49. Does the organization compare trends in  Customer problem resolution
quality and operational performance compared  Comparison of trends to objectives
with progress toward objectives and lead to (goals)
action to support the following:  Specific actions to trend analysis
- Development of priorities for prompt  Prioritization of action.
solutions to customer related problems?
- Determination of key customer related
trends and correlation for status review,
decision making and longer term planning?
- An information system for the timely
reporting of product information arising from
usage?

Rejected Product Test / Analysis

50. Does the organization analyze parts rejected  List of returned parts
by the customer’s manufacturing plants,  Records of analysis
engineering facilities, and dealerships?  Minimization of cycle time

51. Does the organization minimize the cycle time  Review product test/analysis process
of its rejected product test/analysis process?

52. Does the organization keep records of its  Records

rejected product test/analyses and make
available upon request?

53. Does the organization perform analysis and,  Examples

initiate corrective action to prevent recurrence?
Signature of Auditee: Signature of Auditor: Rev. No.: 00
Date:

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