Internal Audit Checklist for Production

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

Control of Production and Service Provision
1. Does the organization plan and carry out  Tour of plant and facilities.
production and service provision under the  Master Sample
following controlled conditions, as applicable:  Work instructions at work stations
a) The availability of information that describes
the Characteristics of the product?
b) The availability of work instructions, as
necessary?
c) The use of suitable equipment?
d) The availability & use of monitoring &
measuring devices?
Control Plan
2. Does the organization:  Control plans for different product levels.
- develop control plans at the system,  PFMEA were used as inputs to the
subsystem, component and /or material level, control plans.
for the product supplied, including those for
bulk materials produced by the organization
and all purchased products and materials?
- Have a control plan for pre-launch and
production that take into account the
manufacturing process FMEA outputs?
3. Does the organization’s control plan:  Review of control plans
- List the control used for the manufacturing  Control plans for applicable stage
process control?  Control plan framework with data.
- Includes methods for monitoring and
recording results of control exercised over
special characteristics (8.3.2.3 of ISO
9001:2015:(E)) defined by both the customer
and the organization?
- Include the customer-required information if
any?
- Initiate the specified reaction plan ( 8.2.3.1 of
ISO 9001:2015:(E)) when the process
becomes unstable or non- capable?

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S.N Requirements What to look for Assessor notes / Objective evidence
4. Does the organization review and update control  Matching between product / process
plans when any change occurs affecting product, changes instability/ non-capability
manufacturing process, measurement, logistics, process resulting, and control plans
supply sources of ISO 9001:2015 (E))? updating

5. Has the organization prepare documented work  Availability of job instruction at the
instructions for all employees having workstation.
responsibilities for the operation of processes?

6. Are the organization’s work instructions  Availability of job instruction at the

accessible for use at the workstation? workstation

7. Are the organization’s work instruction derived  Link between job instructions and source
from sources such as the quality plan, the control documents, e.g. Control Plan,
plan and the product realization process?

8. Does the organization verify job set-ups  Job set-up records and approval
whenever performed?

9. Are the organization’s work instructions available  Set-up instructions

for set-up personnel?

10. Does the organization use statistical methods of  Job set-up records
verification of job set-ups where applicable?

11. Does the organization validate any processes for  Process validation/capability studies
all its production and service provision where the results.
resulting output cannot be verified by subsequent  Process parameters monitoring and
monitoring or measurement? control evidence

12. Does the organization’s validation of process for  Process validation / capability studies

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S.N Requirements What to look for Assessor notes / Objective evidence
all its production and service provision results.
demonstrate the ability of these processes to
achieve planned results?

13. Has the organization establish arrangements for  Requirements specification for
all its processes for production and service operations, equipment and personnel.
provision including, as applicable:  Related records of qualification
a) Defined criteria for review and approval of the  Frequency and conditions of revalidation
processes?
b) Approval of equipment and qualification of
personnel?
c) Use of specific methods and procedures?
d) Requirements for records?
e) Revalidation?

14. Does the organization identify the product by  Check for positive recall
suitable means throughout product realization?  Suitable product identification throughout
the facility
 Tractability from raw material to delivered
product

15. Does the organization identify the product status  Clear identification of work in-process;
with respect to monitoring and measurement finished goods and rejected goods and /or
requirements? components
 Inspection records

16. Where traceability is requirement, does the  Traceability system

organization control and records the unique
identification of the product (4.2.4 of ISO
9001:2015?)

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S.N Requirements What to look for Assessor notes / Objective evidence
17. Does the organization report to the customer and  Damage to customer supplier product
maintain records for customer property that is reports.
lost, damaged otherwise found to be unsuitable  What happened to customer owned
for use? returnable packaging? How was it
accounted for?

Customer Tooling
18. Are the customer-owned tools, tooling and  Permanent identification of tooling and
equipment permanently marked so that the equipment ownership.
ownership of each item is visible, and can be
determined?

Preservation of Product
19. Does the organization preserve the conformity of  Procedure development and -
product during internal processing and delivery to documentation.
the intended destination?  Plant tour

20. Does the organization’s preservation of product  Product preservation procedures

include identification, handling packaging,  Plant tour
storage and protection?

21. Does the organization’s preservation of  Scope product preservation procedures

production apply to the constituent parts of a  Plant tour
product?

7.5.5.1 Storage and Inventory

22. Does the organization use an inventory  Inventory management system
management system to optimize inventory turn  Evidence of FIFO
over time and assure stock rotation?  Control of obsolete product

23. Where necessary to ensure valid results, are the  Test equipment inventory

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S.N Requirements What to look for Assessor notes / Objective evidence
organization’s measuring equipment:  Certification for calibration masters and
a) Identified to enable the calibration status to their tractability to international national
determined? recognized standard.
b) Safeguarded from adjustment that would  Calibration results records.
invalidate the measurement result?  Method of control of calibration settings.
c) Protected from damage and deterioration  Calibration status identification.
during handling, maintenance and storage?

Production Scheduling
24. Is the organization’s production scheduled in  Process for production scheduling
order to meet customer requirements?  The scheduling system should be based
on a “pull” and not on a “push” system.

Monitoring and Measurement of Manufacturing Processes

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 document the results of  Process study reports
process studies with specifications, where  Plan / executed actions form process
applicable, for means of production, study results.
measurement and test, and maintenance
instructions?

27. Does the organization document include  Monitoring & measurement of

objectives for manufacturing process capability, manufacturing process documents.
reliability, maintainability & availability, as well as
the acceptance criteria?

28. Does the organization maintain manufacturing  Current Cpk/Ppk versus customer
process capability or performance as specified by approved Cpk/Ppk
the customer part approval process  Existing reaction plan.
requirements?  Verifying the accuracy of Cpk /Cpk
calculations.
29. Does the organization ensure that the control  Review of production line to process flow

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S.N Requirements What to look for Assessor notes / Objective evidence
plan and process flow diagram are implemented, diagram and control plan
including adherence of the specified:
- Measurement techniques?
- Sampling plans?
- Acceptance criteria?
- Reaction pans when acceptance criteria are
not met?

30. Does the organization note significant process  Review of control charts
events on the control charts such as tool change
or machine repair?

31. Does the organization initiate the appropriate  Records of reaction taken.
reaction plan from the control plan for
characteristics that are either unstable or non-
capable?

32. Does the organization’s reaction plan for  Contents of reaction plan for unstable and
characteristics that are either unstable or non- non-capable processes.
capable include containment of product and  Records
100% inspection as appropriate?

33. Does the organization establish a corrective  Corrective action reports.

action following the initiation or reaction plans,
indicating specific timing and assigned
responsibilities to assure that the process
becomes stable and capable?

34. Are the organization’s corrective action plans  Corrective action approval process
reviewed with and approved by the customer  Corrective action reports.
when so required?

35. Does the organization maintain records of  Records of process change dates.

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S.N Requirements What to look for Assessor notes / Objective evidence
effective dates of process changes?

Control of Nonconforming Product

36. Does the organization ensure that product which  Follow one or more nonconforming case
does not conform to product requirements is and verify the flow (identification),
identified and controlled to prevent its unintended segregation, etc.)
use or delivery?  Obsolete products

37. Does the organization classify unidentified o r  Follow one or more nonconforming case
suspect status product as nonconforming and verify the flow (identification,
product? segregation, etc.).

Control of Reworked Product

38. Are the organization’ s instructions for rework,  Rework instructions
including re-inspection requirements accessible
and utilized by the appropriate personnel?

Manufacturing Process Improvement

39. Does the organization’s continual improvement  Records showing improvement in special
focus upon control and reduction of variation in characteristics,
product characteristics and manufacturing  Reduction in process parameter variation.
process parameters?

Infrastructure
40. Does theorganisation maintain the infrastructure  Quality manual according to ISO
needed to achieve conformity to product 9001:2015
requirements? Product results – internal and external
product failure rate.
Contingency Plans
41. Has the organization prepare contingency plans  Contingency plans -
to satisfy the customer requirements in the event  Identification of Key Equipment
of an emergency such as utility interruptions,
labour shortages, key equipment failure, and field
returns?

Work Environment

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S.N Requirements What to look for Assessor notes / Objective evidence
42. Does the organization manage the work  Work environmental relevant to physical
environment needed to achieve conformity to working
product requirement?  Work environment relevant to product
requirement

Preventive and Predictive Maintenance

43. Does the organization identify key process  Existence of preventive maintenance.
equipment and provide resources for
machine/equipment maintenance and develop an
effective planned total preventive maintenance
system?

44. Does the organization’s preventive maintenance  System effectiveness demonstrated by

system minimum include the following : specifics measurement indicator
- Planned maintenance activities?  Key equipment list.
- Packaging and preservation of equipment,  Key equipment list
tooling and gauging?  Maintenance records
- Availability of replacement parts for key  Predictive maintenance examples
manufacturing equipment?  Plant tour
- Documenting, evaluating and improving
maintenance objectives?

45. Does the organization utilize predictive  Predictive maintenance examples

maintenance methods to continually improve the
effectiveness of its preventive system?

Signature of Auditee: Signature of Auditor: Rev. No.: 01

Date:

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