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"audit procedure". So, this article includes
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1.0 PURPOSE
The purpose of this procedure is to assess
the conformity of our quality management
system to specified requirements and its
effectiveness in meeting quality objectives.
2.0 SCOPE
This procedure covers scheduling, initiating,
planning, conducting, recording, and
reporting internal audits. It also addresses
qualifying auditors, performing follow-up
audits, and managing the overall audit
program.
This procedure applies to internal audits for
all functional areas involved in performing,
verifying, supporting, and managing our
quality-related
activities.
3.0 REFERENCES
3.1 Internal Audit Schedule, file PLAN.XLS
3.2 Corrective Action Procedure, QA-P-014
3.3 Prior internal and external audit
reports
3.4 Documents for the areas to be audited:
- Quality Manual policies
- Department procedures
- Plans and specifications
- Work instructions and forms
3.5 Customer contracts
3.6 Statutes and regulations
3.7 Applicable standards
4.0 RESPONSIBILITIES
4.1 Quality Manager
Performs the duties of the audit program
manager. Maintains the audit schedule,
initiates audits, assigns qualified auditors,
and manages the overall audit program.
4.2 Internal Auditor
Reviews the applicable documents, considers
prior audit results, prepares an audit
checklist, conducts the audit, and reports
the results.
4.3 Lead Internal Auditor
Carries out the duties of an auditor,
prepares the audit agenda, briefs the auditor
team, conducts the opening and closing
meetings, and issues the audit report.
4.4 Manager of Audited Area
Provides access to information, encourages
employee cooperation, acknowledges any
findings, proposes corrective actions, and
notifies the audit program manager when
actions are complete, effective, and ready
for a follow-up audit.
5.0 PROCEDURE
5.1 Scheduling
The audit program manager creates and
maintains the internal audit schedule. Each
functional area within the quality management
system is audited at least annually. Audits
are conducted such that all activities
corresponding to the requirements of the
Standard are assessed throughout the year.
Departments may be scheduled for more
frequent audits based on the importance of
the area, the status of product quality, and
the results of prior audits. Planned audits
are identified on the internal audit
schedule, along with tracking information
regarding audit completion and closure.
The audit program manager presents the annual
schedule for approval at the Management
Review meeting. Supplemental audits can be
added to the schedule during the year if
warranted by changes to the quality
management system.
5.2 Initiating
The audit program manager refers to the
schedule to identify the audits planned for
the next month. A reminder notice is sent to
the assigned auditors, and the manager of the
area to be audited, at least two weeks prior
to the audit.
5.3 Planning
The audit program manager communicates the
audit objective and scope in the audit notice
sent to the assigned auditors and the
managers of the areas to be audited. The lead
auditor is appointed by the audit program
manager and prepares the agenda for the
audit. The agenda defines the auditor
assignments and identifies the times and
duration for each audited area.
Auditors prepare by reviewing the applicable
parts of the Standard and quality manual, as
well as, applicable plans, procedures, and
instructions for the areas to be audited.
Using this information, the auditors create
checklists identifying the key requirements,
representative samples, expected evidence,
and suggested questions.
5.4 Conducting
The lead auditor briefs the team on the audit
objective, scope, assignments, procedure, and
forms. An opening meeting is held with the
manager of the area to be audited to review
the audit plan and initiate the assessment.
Auditors review documents, interview
employees, examine records, and observe
operations to search for evidence of
conformity to requirements.
If a nonconformity is found, the auditor
discusses it with the person being
interviewed to confirm the facts and seek
agreement with the finding.
5.5 Recording
Objective evidence of conformity with
requirements is captured on the audit
checklist. Any nonconformities are documented on
nonconformity reports and reviewed with the
lead auditor.
The auditor completes the first section of
the nonconformity report (QA-P-17.01) to
describe the requirement and evidence of
nonconformity. The responsible manager for
the identified process completes the next
section by proposing the immediate
correction, as well as, the corrective action
to prevent recurrence of the nonconformity.
The manager of the process completes the
third part of the form when the action has
completed and its effectiveness has been
verified. An auditor completes the final
section during the follow-up audit to close
the finding, as appropriate.
5.6 Reporting
The lead auditor prepares the audit summary
report (QA-P-17.01) with assistance from the
audit team. A closing meeting is held to
share the audit results with the manager of
audited area and seek acknowledgement of the
report.
The lead auditor reminds the auditee that a
representative sample was taken during a
brief time period and nonconformities may
still exist.
Appeals of findings are sent to the audit
program manager for arbitration.
A copy of the audit report is given to the
manager of the audited area. The original
report goes to the audit program manager for
record retention.
5.7 Correcting
The manager of the audited area submits an
action plan within two weeks of the closing
meeting. If the action plan is acceptable,
the audit program manager approves the plan
and notifies the manager to proceed with the
proposed corrective action.
Actions are to be completed within sixty days
of the plan approval, unless a new due date
is negotiated with the audit program manager.
5.8 Verifying
An auditor is assigned to conduct a follow-up
audit and verify the effective implementation
of corrective actions for previously reported
nonconformities.
Follow-up audits are scheduled within two
weeks after receiving notice that the actions
have completed. If the audit program manager
has not received the notice by the due date,
a reminder note is sent to the manager of the
audited area.
If after one additional week the action has
not completed, an overdue note will be sent,
with a copy going to the manager's manager.
If more work is still needed to complete the
corrective action, a new due date must be
negotiated with the audit program manager.
5.9 Training
The audit program manager selects auditors
that are open-minded, impartial, objective,
and possess sound judgment. These personal
traits, along with company experience, are
considered important auditor attributes for
conducting effective audits.
Auditors receive classroom training in
auditing techniques and Standard
requirements, observe an audit conducted by a
qualified auditor, and then participate as
members of an audit team. The audit program
manager maintains records of the auditor
training and the list of qualified auditors.
5.10 Managing
The audit program manager maintains the audit
schedule and assigns qualified auditors that
are independent of the areas to be audited.
The audit program manager tracks the status
of audits and summarizes the results for
presentation at the Management Review
meetings.
6.0 RECORDS
6.1 Audit Notice (sent via e-mail)
6.2 Audit Summary Report, form QA-P-17.01
6.3 Audit Nonconformity Report, form
QA-P-17.02
6.4 Audit Checklist, form QA-P-17.03
6.5 Internal Audit Schedule, file PLAN.XLS
6.6 Auditor Training Records
6.7 Qualified Auditor List
7.0 ATTACHMENTS
7.1 Sample Audit Summary Report
7.2 Sample Nonconformity Report
7.3 Sample Audit Checklist Section
8.0 REVISION HISTORY
(Include revision level, change description,
changed by, and effective date).
Training
If you want to attend a public internal
auditor class, consider one of these courses.
Enroll at least 60 days in advance of the
class date and receive the discounted fee
shown below:
ISO 9001 Internal Auditor - Quality - 3 days
- $1016
AS9100
Internal Auditor - Aerospace - 3 days
- $986
ISO/TS
16949 Internal Auditor - Automotive -
3 days - $1016
ISO
13485 Internal Auditor - Medical Devices
- 3 days - $1016
ISO
20000 Internal Auditor - IT Services - 3
days - $1356
ISO
27001 Internal Auditor - Information
Security - 3 days - $1271
ISO
14001 Internal Auditor - Environmental -
2 days - $931
If you want to arrange an on-site internal
audit class, please contact me for a quote.
We also have cost-effective 2-day on-site
versions for most of the courses.