Process Audit
Checklist
Guidance
About this Checklist
The audit checklist is just one of the many tools which are available from the auditor’s toolbox tha
requirements. It stands as a reference point before, during and after the audit process and if developed for a
following benefits:
Ensures the audit is conducted systematically;
Promotes audit planning;
Ensures a consistent audit approach;
Actively supports your organization’s audit process (ISO 9001:2015, Clause 9.2.1);
Provides a repository for notes collected during the audit;
Ensures uniformity in the performance of different auditors;
Provides reference to objective evidence.
This audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0
question. This audit checklist may be used for element compliance audits and for process audits. If you wish
clauses from the tables below that are relevant to the process and copy and paste the audit questions into a
retain this audit checklist as your ‘master copy’.
Audit Scoring Criteria
A risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to y
assurance that key risks to your organization’s objectives are being well controlled.
The audit findings ‘traffic lights’ are intended to visually communicate the risk posed by the audit finding of a
system is stratified from ‘compliant’ to ‘major non-conformance’ to convey a concise and consistent method
you can transfer the findings into an Excel spreadsheet to create charts, summary tables and trend data to p
documentation.
This methodology should be uniformly applied to all types of internal audit (gap analysis, system audits and p
undertake.
Finding
COMPLIANT
OFI
MINOR N/C
MAJOR N/C
Process Audit
Checklist
Guidance
About this Checklist
he audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure
equirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit
ollowing benefits:
Ensures the audit is conducted systematically;
Promotes audit planning;
Ensures a consistent audit approach;
Actively supports your organization’s audit process (ISO 9001:2015, Clause 9.2.1);
Provides a repository for notes collected during the audit;
Ensures uniformity in the performance of different auditors;
Provides reference to objective evidence.
his audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0 of ISO 9001:2
uestion. This audit checklist may be used for element compliance audits and for process audits. If you wish to create separ
lauses from the tables below that are relevant to the process and copy and paste the audit questions into a new audit chec
etain this audit checklist as your ‘master copy’.
Audit Scoring Criteria
risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to your organizati
ssurance that key risks to your organization’s objectives are being well controlled.
he audit findings ‘traffic lights’ are intended to visually communicate the risk posed by the audit finding of any system or p
ystem is stratified from ‘compliant’ to ‘major non-conformance’ to convey a concise and consistent method for scoring eac
ou can transfer the findings into an Excel spreadsheet to create charts, summary tables and trend data to paste into your
ocumentation.
his methodology should be uniformly applied to all types of internal audit (gap analysis, system audits and process audits)
ndertake.
Definition/Impact
Compliant means adherence with the requirements of the standard and the QMS. The process is
implemented and documented and records exist to verify this.
A low risk issue that offers an opportunity to improve current practice. Processes may
cumbersome or overly complex but meet their targets and objectives. Unresolved OFIs may
degrade over time to become non-compliant.
A medium risk, minor non-conformance resulting in deviation from process practice not likely to
result in the failure of the management system or process that will not result in the delivery of
non-conforming products nor reduce the effectiveness of the QMS.
A high risk, major non-conformance which directly impacts upon customer requirements,
likely to result in the customer receiving non-conforming products or services, or which may
reduce the effectiveness of the QMS.
s Audit
st
uditor’s toolbox that help ensure your audits address the necessary
nd if developed for a specific audit and used correctly will provide the
n 4.0 to Section 10.0 of ISO 9001:2015, each required is phrased as a
s audits. If you wish to create separate process audit checklists, select the
udit questions into a new audit checklist. We suggest that you
g the major risks to your organization. The audit’s role is to provide
the audit finding of any system or processes being audited. The rating
consistent method for scoring each audit finding. At the end of the audit,
and trend data to paste into your audit report or management review
system audits and process audits) that your organization will likely
Action/Mitigation
Continue to monitor trends/indicators.
Review and implement actions to improve the process(s). Monitor
trends/indicators to determine if improvement was achieved.
Investigate root cause(s) and implement corrective action by next
reporting period or next scheduled audit.
Implement immediate containment action, investigate root
cause(s) and apply corrective action. Re-audit in 4 weeks to verify
correction.
Process Activity Map PERSONNEL:
Review employee skill lists for the process. Are
EQUIPMENT & FACILITIES: there lists of skills for each position? Do they show
What equipment and resources are required? enough detail? This is often a finding, where lists
Is equipment suitable and properly maintained? are generic with inadequate detail. Training is a ke
Is the work environment maintained? process of any system. Are there particular skills yo
Is there evidence of appropriate maintenance of all want to evaluate?
equipment used by this process?
PROCESS INPUTS: PROCESS NAME/DESCRIPTION:
What triggers the process? What inputs are What steps are involved in the process? What happens at
required? each step in the process? What documents and records ar
Where do the inputs come from? generated?
Are they received in a timely manner? Are they fit Is the process implemented in accordance with
for purpose? procedures, instructions or plans?
Are controls applied as described?
INSTRUCTIONS & PROCEDURES:
Review the documents that describe and control the
process. Review all the important steps and activities
of the process being audited. This info must be
documented within the QMS. Evaluate how effectively
the process flows through the steps. Do you see
roadblocks or issues?
PERSONNEL:
Review employee skill lists for the process. Are
there lists of skills for each position? Do they show
enough detail? This is often a finding, where lists
are generic with inadequate detail. Training is a key
process of any system. Are there particular skills you
want to evaluate?
PROCESS NAME/DESCRIPTION:
What steps are involved in the process? What happens at
each step in the process? What documents and records are
generated?
Is the process implemented in accordance with
procedures, instructions or plans?
Are controls applied as described?
SUPPORT PROCESSES:
As you audit, you will see how it connects and
interacts with other processes. Interactions with other
processes are always important. As you audit the,
you will see how it connects and interacts with
other processes. Audit the relevant links to related
processes and support processes.
CONTROL PROCESSES:
How is the process defined and who is
responsible? How are customer requirements
defined? What specifications apply defined?
What objectives and targets apply process?
What controls/check points are there? What
acceptance criteria exist?
PROCESS OUPUTS:
What is the product produced by this process? Are
product measures in place to ensure that product
meets requirements?
How are processes measured?
Are product and process measures achieved? What
feedback is received from customers?
KEY PERFORMANCE INDICATORS:
Review metrics and performance with Managers,
Supervisors and operators. They should know how
things are running, objectives, customer
issues, problem areas. If they do not, the
requirements were not met. Is there evidence that
quality objectives and targets affected by this
process are being achieved?
Process Audit Checklist
Process Definition
Audit Findings
(Score ‘1’ per box)
COMPLIANT
Ref Audit Question
MINOR N/C
MAJOR N/C
OFI
1 Is the process defined and documented?
2 Is the process owner identified? (Process map, procedure
or work instruction, etc.)
3 Is there evidence that process inputs are accurately
defined and understood by all employees involved?
4 Is there evidence that process activities are accurately
defined and understood by all employees involved?
5 Is there evidence that process outputs are accurately
defined and understood by all employees involved?
6 Are inputs defined and prioritized based on risk?
7 Have procedures, instructions, and forms been
established as needed to control the process?
8 Are procedures, instructions and forms used in controlling
the process readily available?
9 Do procedures, instructions and forms accurately reflect
the practices? (Note: Requires the auditor review and
observation!)
10 Are there adequate plans in place to achieve the
objectives?
11 Is relevant customer feedback available? (Feedback from
subsequent processes)
12 Are documents understood by process participants?
Audit Evidence Opportunities for
Improvement (OFI)
Provide reference to documented Provide suggestions for process
information to justify the finding improvement
Process Resources
Audit Findings
(Score ‘1’ per box)
COMPLIANT
Ref Audit Question
MINOR N/C
MAJOR N/C
OFI
13 Is there evidence of management commitment,
involvement and allocation of resources?
14 How many people participate in the process, is this
adequate to achieve process requirements?
15 Are participants adequately trained to carry out roles,
responsibilities, and authorities?
16 Is equipment (e.g. manufacturing, measuring &
monitoring equipment; transport/logistics;
hardware/software; PPE; etc.) adequate for its intended
use?
17 Is equipment identified to allow participants to determine
its readiness for safe use prior to and during the
operation?
18 Are process owners accountable for the performance and
compliance of their processes?
19 Are employees satisfied with their work area?
20 Is the work area clean and safe?
21 Is there adequate equipment/tools/IT support?
22 Are employees motivated and encouraged to make
suggestions for process improvement?
23 Are all employees aware of the organizational objectives
and the current status of these measurements?
24 Are all employees aware of who their customers are and
whether they are satisfied?
25 Are employees aware of the process metrics which their
activities can affect?
26 Are they aware of the current data analysis related to
these metrics and the plans in place to achieve them?
Audit Evidence Opportunities for
Improvement (OFI)
Provide reference to documented Provide suggestions for process
information to justify the finding improvement
Process Execution
Audit Findings
(Score ‘1’ per box)
COMPLIANT
Ref Audit Question
MINOR N/C
MAJOR N/C
OFI
27 Is the observed process activity consistent with approved
plans and procedures?
28 Is the process flow constructed to avoid unnecessary
movement of materials and personnel?
29 Are redundant and non-value adding activities minimized?
30 Is material usage maximized to avoid waste?
31 Is waste material effectively removed and segregated
from the process?
32 Are unused materials returned to the correct location in
conditions suitable to allow re-use?
33 Are process outputs passed on to subsequent processes
only when all planned process activities are completed?
34 Is there evidence of continuity between the various
support processes?
35 Do the interfaces between the departments operate
smoothly?
36 Does product information flow freely between the support
processes?
37 Is there evidence for the reduction in measurement
system and process variation?
Audit Evidence Opportunities for
Improvement (OFI)
Provide reference to documented Provide suggestions for process
information to justify the finding improvement
Process Monitoring
Audit Findings
(Score ‘1’ per box)
COMPLIANT
Ref Audit Question
MINOR N/C
MAJOR N/C
OFI
38 Is the process monitored, measured, analyzed and
improved?
39 Are monitoring activities carried out according to
approved plans and procedures?
40 Is process monitoring compared against standards to
determine the current status of the process?
41 Is process status communicated to appropriate members
of the process team?
42 Are records of process monitoring maintained according
to approved procedures?
43 Have key performance indicators (KPI) been established
to allow the effectiveness of the process to be evaluated?
44 Are KPI consistent with quality and business objectives?
45 Are KPI consistent with customer requirements?
46 Are KPI reviewed and communicated to the process team,
as appropriate, by process leaders?
47 Is the process measured for effectiveness and efficiency?
48 When a process is not performing, is there evidence of
data analysis to determine the root cause?
49 When a process is not performing, is there evidence that
the cause(s) are dealt with in accordance with procedure?
50 Are records of process monitoring reviewed regularly to
determine opportunities for corrective and preventive
action?
Audit Evidence Opportunities for
Improvement (OFI)
Provide reference to documented Provide suggestions for process
information to justify the finding improvement
Process Improvement
Audit Findings
(Score ‘1’ per box)
COMPLIANT
Ref Audit Question
MINOR N/C
MAJOR N/C
OFI
51 Is the performance of the process reviewed at an
appropriate frequency by top management?
52 Are process improvement objectives aligned with
organizational objectives, e.g. the business plan?
53 Is there evidence of an effective PDCA cycle?
54 Can the process owner demonstrate how PDCA applies to
their process?
55 Can the process owner to show examples of
improvements driven by their PDCA cycle?
56 Can employees demonstrate areas of previous continual
improvement?
57 Are records of process upsets and actions taken reviewed
to determine the need for corrective/preventive action?
58 Where corrective/preventive actions have been
implemented, have the action(s) taken been
demonstrated as effective?
59 Where opportunities for improvement have been
implemented, have the action(s) taken been
demonstrated as effective?
60 Are all process participants encouraged to be involved in
identifying improvements?
Audit Evidence Opportunities for
Improvement (OFI)
Provide reference to documented Provide suggestions for process
information to justify the finding improvement
Findings Summary
Non-conformance
No. ISO/Specification Ref. Summary
Corrective Action
No. ISO/Specification Ref. Summary
Opportunities for Improvement
No. ISO/Specification Ref. Summary
Observations, Comments & Notes
Root Cause NCR No. Rectification Date
Root Cause CAR No. Rectification Date
Root Cause PAR No. Implementation Date
