Process Audit Planning Checklist

This checklist is designed to be used as an aid in planning process-based audits of one or more production
processes. It contains requirements associated with key inputs, resources and controls related to manufacturing
operation, as defined in ISO 9001:2000. Auditors can review the checklist and pull out requirements relating to
areas for focus based the auditors review of internal and external data and performance metrics.
Although this checklist could be used to evaluate a process, its size and complexity restrict its normal use to
audit planning. Normally, the shortened versions of this checklist (QMS Audit Checklists 1, 2 and 3) would be
used to perform the audit. This Process Audit Planning Checklist could be carried with the auditor during the audit
as a reference tool in case the auditor determines the need to probe deeper into an area such as maintenance,
training, or inspection and testing. In these instances the auditor can refer to the additional questions contained in
this full comprehensive checklist. Parenthetical references on QMS Audit Checklists 1, 2 and 3 refer back to the
page where the item is addressed on this comprehensive checklist.
To use this checklist system for production process evaluation, the auditor should make 1 copy of QMS Audit
Checklist 1 (Area Owner/Manager) for the production supervisor of the process being evaluated and one copy of
QMS Audit Checklist 2 (Basic Production Process) for each workstation to be visited during the audit. In
addition, the auditor should make one copy of QMS Audit Checklist 3 (Basic Preservation Process) if the
evaluation will trace back to the final shipping and warehousing operations. One audit checklist will be used for
each person interviewed or workstation visited. The auditor can refer to this full Process Audit Planning Checklist
for additional questions if the need arises. The audit program manager or lead auditor could also pull specific
pages from this checklist and provide them to the auditors if a more thorough evaluation of one of the items on
this checklist were desired.
Space has been provided in the right hand columns of all of the checklists for the auditors to note objective
evidence and comments. These fields for data entry not only serve to document the audit process but also help
ensure the thoroughness of the audit. Audit program managers should ensure that auditors complete the
information in the right hand column.
Auditors should note that this checklist does not include local requirements, or additional requirements of specific
customers. The checklist also does not include other critical inputs, resources and controls that may be necessary
for proper process operation, but which are not directly addressed in the ISO 9001:2000 standard. For this reason,
auditors must fully review the processes to be evaluated, including inputs, resources, controls and current
performance metrics prior to the audit. Additional areas for evaluation can be added to these checklists for
ongoing audit planning, or placed on checklists that will be used during the audit. The first two pages of the
checklist serve to focus the auditors review and planning for the audit.

As a final feature, some of the questions included in this checklist have embedded tips and hints on how to
evaluate the area or the auditees response to the question. To access these tips, the auditor must ensure that the
form is locked (go to View/Toolbars/Forms on the MS Word main menu and depress the lock icon). Then place
your mouse over the checkbox next to the question and press the F1 key on your keyboard. Items containing tips
are designated with an * next to the checkbox. The forms must be unlocked if it is desired to modify the checklist
or comments.

2004 Joe Kausek & Associates

ISO 9001:2000 General Requirements Production Process Core Checklist

Reviewer Checks

Reviewer Checks

Planning the Process Audit

Sketch the rough process flow, including key inputs
and primary outputs. Use a separate sheet if needed.
Inputs
Process
Outputs

Determine the processes/activities to be included in the scope

of the audit. The scope may be provided as part of an audit
schedule or plan, or it may need to be developed by the audit
program manager. List the process(es) below:
Processes
Document No.

Consider the following information relating to the processes to

be examined.
Previous audit results of the production process
Current process metrics relating to production,
maintenance or logistics
Any open or recent corrective actions, complaints relating
to production, maintenance or logistics
History of returned product, returned product analysis, and
customer feedback
Quality objectives relating production or support activities
Recent lessons learned
Auditee management
Other (list) _____________________________________

Based on your review, add, delete, or modify the

questions on this checklist to focus your evaluation
and to incorporate local requirements and inputs. This
is especially important for production related
activities since most of the requirements will be
spelled out in local procedures and instructions.

2004 Joe Kausek & Associates

Corrective Actions and Current/Recent problems

List any problems, CARs, or items from previous
audits that should be evaluated or verified during this
audit.
Problems noted for later examination:

Review the core process metrics relating to production and

related support activities (quality, cycle-time, throughput, cost).
Metric
Recent Performance
Trend
1.
2.
3.
4.
5.
Objectives and/or targets to review:
1.

2.

2004 Joe Kausek & Associates

Realization Process
Operator Instructions
Are operator instructions/work
instructions available for all
employees responsible for production
operations of this process?
*

Are instructions up-to-date?

Are they accurate and complete?

Are they being complied with?

Review the operator instructions for the process(es) being reviewed. Note
that the level of detail depends on the complexity of the task and skill and
experience of the operators. If the level of detail in the instruction is minimal,
then verify the operators have adequate training by observing several doing
the same task. Investigate any differences in the way they perform it as this
may indicate a weakness or a best practice opportunity.
This question is core to the overall process audit. Spend enough time to
ensure that the process is being operated consistently and in conformance
with the instructions/guidance provided. Talk with operators about the
adequacy of process instructions. Note any potential improvements or best
practices (areas of strength) in the overall evaluation below. List the process
instructions evaluated below, along with any relevant comments/issues.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Area of Strength. Detail below. Be specific.
Nonconformity. Provide details below. Reference the specific
requirement violated.
Process Instruction #

Comments

1.
2.
3.
Do they include customer special
characteristics (if applicable)?

4.
5.
6.
Comments and Findings

Reference
ISO 16949:2002 7.5.1.2
Note, use a separate sheet or the
reverse side of this checklist if
necessary.

2004 Joe Kausek & Associates

Input/Resource Category - Process Information

Document Control - General

The auditor should verify that (1) documents needed to

perform the work are available (electronically or in hardcopy), and that (2) these documents are properly controlled. In
general, the operator should have something telling them what
to do, although the level of detail may vary widely depending
on the complexity of the task and the skill and training of the
operators. The auditor should look for consistency of actions
between operators in situations where instructions have not
been provided or where they provide very minimal detail.
Note that the adequacy/compliance to operator instructions is
examined in the realization process item later. This item deals
only with document control.

Review the documents used at each

process/workstation. Are they:

Controlled?

The correct revision level?

Legible?

Approved by the person authorized?

Accessible without job disruption?

information?

*
*

Do they contain the correct

*

Are changes to documents highlighted in the

document or attachments?
*

Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Documents Reviewed (list):
Document No.
Rev. Date
Conforming?
1.
2.
3.
4.
5.
6.
Comments and Findings

Reference
ISO 9001 4.2.3
2004 Joe Kausek & Associates

Input/Resource Category - Resources and People

Responsibilities and Authorities
Are process operators responsibilities and
authorities relating to the operation of the process
clearly defined and documented? *
Are operators aware of their responsibilities for the
control of nonconforming products? Reaction plans?
*

This item seeks to ensure everyone understands his or her job.

This item should be considered for each workstation/activity
that is part of the audit. Overall responsibilities and authorities
must be documented, while responsibilities for individual
steps do not. In the latter case, verify everyone understands
their job, especially for unusual events such as disposition of
nonconforming material, implementation of reaction plans,
and so on.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.

Reference
ISO 9001 5.5

Internal Communication
Are process operators and personnel aware of how
well their process is performing? Are they provided
with information relating to process performance?
Can they communicate the major quality issues
relating to this area or process? *

If the process metrics indicate poor process

performance or deteriorating trends, is there an
improvement plan in place?

Task Resp. 1______________________

Yes

No

Task Resp. 2______________________

Yes

No

Task Resp. 3______________________

Responsibilities/authorities for control of NCP
Comments and Findings

Yes
Yes

No
No

The purpose of internal communications is to ensure that

personnel are aware of significant information relating to the
performance of their process or the product.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Awareness Topic
Aware?
Quality Performance
Yes No
Current quality problems/issues
Yes No
Safety Performance and issues
Yes No
Efficiency Performance
Yes No
Other _________________________________
Yes No
Other _________________________________
Comments and Findings

Yes

No

Reference
ISO 9001 5.5.3

2004 Joe Kausek & Associates

Training
Observe the operators performing the process. Do
they appear to be competent? *

Are process operators aware of the quality policy

and how it relates to their job? *

Are operators aware of the importance of their work

to the QMS? *

Is there evidence that the personnel operating

process being audited have the necessary
competencies/training needed? *

Are contract and/or agency personnel properly

trained? *

This item seeks to determine if operators are competent to do

the work assigned to them, and if they are aware of the
impacts/significance of their work. The auditor should observe
the operator(s) to the extent he/she is satisfied that the operator
can do the job. Furthermore, the auditor should check training
records and competency matrices later to ensure the
competencies needed for the job have been identified, and
provided for the operators sampled.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.

Note the names and functions of several of the

operators/employees involved in this process. Verify through
observation and interviews that operators understand their
work, and that required training/actions have been completed.
Operator Name

Appear
Evidence of
Competent?
Training
______________________
Yes No
Yes No
______________________

Yes

No

Yes

No

______________________

Yes

No

Yes

No

______________________

Yes

No

Yes

No

______________________

Yes

No

Yes

No

Comments and Findings

Reference
ISO 9001 6.2

2004 Joe Kausek & Associates

Resource Management
Does it appear that adequate staffing (right number
and right skills) has been provided for operation of
this process? *

Are there any problems related to this process that

can be directly tied to the non-availability of a
resource?
Remember no-one ever feels they have all the
resources they need. The auditor must verify that
there is a negative impact, supported by objective
evidence, before citing resources as a finding.
Provide detailed information and evidence,
including evidence of the impact of the resource
issue, in the right column. *

Resource availability and use is a difficult area to audit. The

auditor should look for problems, possibly connected with
other questions asked, that can be tracked back to nonavailability of resources. Unless there is a related violation,
then resources are considered adequate.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Process/Area
_______________________________________
Staffing
Equipment
Materials
Time
adequate?
adequate?
adequate? adequate?
Yes No
Yes No
Yes No
Yes No
Comments, Impacts and Objective Evidence

Process/Area
_______________________________________
Staffing
Equipment
Materials
Time
adequate?
adequate?
adequate? adequate?
Yes No
Yes No
Yes No
Yes No
Comments, Impacts and Objective Evidence

Process/Area
_______________________________________
Staffing
Equipment
Materials
Time
adequate?
adequate?
adequate? adequate?
Yes No
Yes No
Yes No
Yes No
Comments, Impacts and Objective Evidence

Process/Area
_______________________________________
Staffing
Equipment
Materials
Time
adequate?
adequate?
adequate? adequate?
Yes No
Yes No
Yes No
Yes No
Comments, Impacts and Objective Evidence

Reference
ISO 9001 6.1

2004 Joe Kausek & Associates

Input/Resource Category - Materials and Parts

Product Identification and Traceability
Are all input materials and parts suitably identified?
*

If traceability is a requirement, are the

materials/parts uniquely identified? *

Can the inspection status (good or bad) be

determined? *

This item evaluates proper control of materials and parts.

Product identification should ensure the proper parts and
materials get into the product. In general, the auditor should
verify that all incoming materials and parts can be identified
by some means.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Comments and Findings

Reference
ISO 9001 7.5.3
Control of Customer Supplied Product
Are all customer-supplied parts and materials
properly controlled? *

Are customer-supplied tooling, equipment and

vehicles properly maintained? *

Reference
ISO 9001 7.5.4

2004 Joe Kausek & Associates

This item evaluates proper control of customer supplied

property and product, including shipping racks, molds, and
equipment. Customer supplied property must be properly
maintained and handled to ensure it is not damaged while
under the companys control.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Customer Property
Maintained?
_______________________________

Yes

No

_______________________________

Yes

No

_______________________________

Yes

No

_______________________________

Yes

No

Preservation of Product

Are handling controls sufficient to prevent damage

or deterioration of product? *

This item evaluates whether materials, parts and products are

properly handled, stored, packaged and preserved to prevent
damage or deterioration. It includes any materials storage
areas associated with the process under review, including
work-in-process areas, as well as final storage.

Are material/parts properly stored while awaiting

use? *

Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.

Are materials properly packaged (per specifications

if applicable)? *

Comments and Findings

Reference
ISO 9001 7.5.5
Control of Nonconforming Product
Is nonconforming product controlled in a manner
that will prevent its unintended use or delivery? Is it
identified? *

Is nonconforming product properly dispositioned?

Do the personnel performing the disposition have
the authority to do so?

This item seeks to evaluate the control of any nonconforming

product associated with this process.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Comments and Findings

Is nonconforming product reevaluated after

rework/repair?

Reference
ISO 9001 7.5.5.1

2004 Joe Kausek & Associates

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Input/Resource Category - Inspections, Monitoring and Controls

Inspection and Testing (including Statistical
Monitoring)

This item evaluates whether inspection, monitoring and testing

called out in the control plan, inspection plan or process
instruction is being performed and correctly documented.

Is there evidence that the evaluation and

measurements called out in the Inspection Plan are
being conducted?
*

Are the statistical methods called out in the

inspection plan being performed? If yes, are
personnel aware of basic statistical concepts?

Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Inspection Plan Control

Properly conducted?

___________________________________

Yes

No

___________________________________

Yes

No

___________________________________

Yes

No

___________________________________

Yes

No

___________________________________

Yes

No

___________________________________

Yes

No

Comments and Findings

Reference
ISO 9001 8.1

2004 Joe Kausek & Associates

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Inspection Records
Are records available to show that the inspections
and testing called out in the control plan or
inspection plans have been conducted?
Are the records legible?

Are the records complete?

The purpose of these requirements is to ensure that the records

needed to demonstrate conformance of the product or control
of the process are obtained, properly completed, handled and
then retained to provide information needed for decisions and
actions.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.

Can the record be traced to the operation, process or

product that generated it?

Are the records intended to be used to maintain and

improve the process being retained, and if so, are
they being used for this? *

Records to retrieve:

Comments

1.
Is there a process (e.g. who, when and where) for
collecting the records for analysis and/or storage,
and if so, is it being used?

2.
3.
4.

If it is desired to test the Retrievability of process

records, list the records targeted for retrieval here,
and request that the document/record coordinator (or
appropriate individual) retrieve the record after the
process interviews are complete.

Comments and Findings

Reference
ISO 9001 4.2.4

2004 Joe Kausek & Associates

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Input/Resource Category - Infrastructure - Facilities, Tooling and Equipment (including Test Equipment)
Preventive Maintenance
Have maintenance requirements been
defined for the equipment used in this
process? Were they generated from
manufacturers recommendations,
technical manuals or were they pulled
out of thin air? *

Have the preventive and predictive

maintenance requirements been
completed? Is the maintenance
backlog large? *

Is there evidence that the maintenance

has been effective? *

Reference
ISO 9001 6.3
Work Environment and Cleanliness
of Premises
Is the work environment suitable for
the work being performed on this
process? *

Is the area being maintained in an

appropriate state of order, cleanliness
and repair? *

This item evaluates how well process equipment is being maintained.

Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Process Equipment ________________________________________
Availability
Is there a
PMs
Maintenance
Metrics
basis for PMs?
Completed?
Backlog
______________
Yes No
Yes No _____________
Process Equipment ________________________________________
Availability
Is there a
PMs
Maintenance
Metrics
basis for PMs?
Completed?
Backlog
______________
Yes No
Yes No _____________
Process Equipment ________________________________________
Availability
Is there a
PMs
Maintenance
Metrics
basis for PMs?
Completed?
Backlog
______________
Yes No
Yes No _____________
This item looks for obvious problems with the work environment of
cleanliness of areas associated with the process under review. The auditor
must use considerable judgment and perspective when reviewing this item.
Unless extreme, or unless actual problems can be traced back to these items,
then cite deficiencies as opportunities for improvement vs. NCs.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Comments and Findings

Reference
ISO 9001 6.4
2004 Joe Kausek & Associates

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Control of Inspection, Measuring

and Test Equipment

This item evaluates the adequacy of the control of inspection, measuring and
test equipment used in the process being reviewed.

Is the measuring equipment

associated with this process
calibrated? (7.6 a)

Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.

Is the calibration status apparent and

up to date per defined interval? *

Are calibration/verification records

available?

This information may have already been collected as while addressing the
control plan.
Meas. System
Calibrated?
Satisfactory?
1.
2.

If applicable, was the equipment

calibrated per written instruction?

3.
4.

Is the equipment being properly

handled? *

5.
Comments and Findings

Note several of the devices found in

use. Verify their calibration later
through examination of calibration
records. Note any deficiencies in the
space provided.

Reference
ISO 9001 7.6

2004 Joe Kausek & Associates

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