Internal Audit - SOP

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ISO 9001:2015 QMS Doc. No.

EEP/QMS/CORP/SOP/O4
Location: QMS Manager Issue No. 1

Revision No. 0
Internal Quality Audit Title Page

Internal Quality Audit Procedure

Issued by: Approved by:


Signed: Signed:
Date: Date:
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

Revision No. 0
Internal Quality Audit Page 1 of 17 pages

0.0 Table of contents


0.1 Distribution list
0.2 Amendment sheet record
1. Purpose
2. Scope
3. References
4. Terms and definitions
5. Process requirements
a. inputs and outputs
b. Sequence and interactions
c. Monitoring, measurement and evaluation
d. Resources
e. Responsibilities
f. Risks and opportunities
g. Improvement
6. Method
7. Documented information retained
Appendices
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

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Internal Quality Audit Page 2 of 17 Pages

0.1 Distribution List

This document is issued on controlled basis to the following staff members

Copy No. Copy Holder


1 Chief Executive Officer
2 Executive Officers
3 Directors
4 Managers
5 QMS Manager
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

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0.2 Amendment Sheet Record

NO DATE Details of change Authorization


YYYY-MM-DD Page Clause/sub-clause and comment
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

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Internal Quality Audit Page 4 of 17 Pages

1.0 Purpose
The purpose of this procedure is to provide information on whether the QMS
a) Conforms to:
1) the company’s own requirements for the QMS;
2) the requirements of ISO:2015 standard;
b) is effectively implemented and maintained

2.0 Scope
This procedure covers planning, implementation and maintenance of the audit programme
including the frequency, methods, responsibilities, planning requirements and reporting.

3.0 TERMS AND DEFINITIONS


i. QMS: Quality Management System
ii. CEO: Chief Executive Officer
iii. HOD: Head of Department
iv. HOS: Head of a Section
v. CORP: Corporate
vi. SOP: Standard operating procedures
vii. IQA: Internal Quality Audit
viii. NC: Nonconformity
ix. CA: Corrective action
x. CAR: Corrective Action Request
xi. QMSM: QMS Manager
xii. PM: Process map
xiii. DRIM: Documents and Records Identification Manual

4.0 References
3.1 ISO 9000:2015 QMS Fundamentals and vocabulary
3.2 ISO 9001:2015 QMS requirements
3.2 ISO 19011:2018 Guidelines for auditing management systems
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

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Internal Quality Audit Page 5 of 17 Pages

5.0 Process requirements


5.1 Inputs and outputs
a. Inputs
I. Internal audit procedure
II. Audit plan
III. Audit check lists
b. Outputs
i. Observations/Opportunities for improvements
ii. Nonconformities
iii. Corrective actions requests
iv. Audit reports
5.2 Sequence and interactions
The processes sequence and interactions are captured in the EEP quality manual,
EEP/QMS/CORP/QM, Appendix 1
5.3 Monitoring, measurement and evaluation
a) Number of minor nonconformities
b) Number of major nonconformities
c) Carrying out of corrective actions
d) Audit closure
See also quality manual EEP/QMS/CORP/QM, Appendix 2
5.4 Resources
a) Auditors
b) ISO 9001:2015
c) ISO 19011:2018

5.5 Responsibilities
The QMSM, Auditors and Managers are responsible for the implementation of the
procedure
5.6 Risks and opportunities
The risks and opportunities associated with the processes are documented in the
enterprise risk and opportunities’ register, EEP/QMS/CORP/QMSR/21/1
5.7 Improvement
a. Internal quality audits
b. Corrective actions
c. Audit closure
d. Management reviews
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

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6. METHOD/PROCEDURE
6.1 Audit planning
6.1.1 At the beginning of the year the QMSM will prepare an audit plan
6.1.2 The QMSM shall develop and distribute to the management and staff of all the audit areas an
IQA plan 14 days before the audits start based on the results of previous reports, as well as the
status and importance of the processes and areas.
6.1.3 The QMSM shall appoint auditors from a list of qualified auditors for the various audit areas 14
days before the expected audit date. In appointing the auditors, the QMSM shall ensure
objectivity and impartiality.
6.1.4 The lead auditor/auditor shall prepare an audit timetable and submit it to the auditee and / or
the auditees’ management at least three (3) working days before the start of the audits.
6.1.4 The auditors shall prepare for the desk and site audit by reviewing quality manual, corporate
and operating procedures, work instructions, records, quality objectives and other submitted
QMS documentation and prepare relevant audit questions using the audit checklists as in
appendix 8.2.
6.2 Conduction of audit
6.2.1 On the scheduled date/s the auditors shall carry out the audit as per the audit timetable. The
audit team shall hold an opening meeting with the auditees and the auditees’ management. The
agenda of the opening meeting shall be as per appendix 8.3. Attendance to the opening
meeting shall be recorded.
6.2.2 The auditors shall conduct a documentation/desk audit and determine conformity of the
documents with the requirements of ISO 9001:2015 standard as well as determine
effectiveness of the documentation.
6.2.3 The auditors shall then proceed to execute site audits by asking the audit questions as per the
checklist questions and subsequent follow up questions, interviews, inspections and make
observations. All audit findings shall be recorded in the audit findings form appendix 8.4. The
auditee shall sign against all audit observations as a confirmation of the finding.
6.2.4 After collecting all the audit observations, the auditors shall hold an auditors’ review meeting to
evaluate the audit evidence and come up with audit findings, which shall include observations,
opportunities for improvement and nonconformities (NC).
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM
Issue No. 1

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6.2.5 Where NCs are identified with respect to the documentation and site audits, the auditors will
raise a CAR for each NC as per appendix 3 and submit to the auditee for signing as an
acceptance of the NC’s and undertaking of corrective action(s). The lead auditor shall agree
with the auditee on the follow-up date, which shall not be more than 30 days from the audit
date.
6.2.6 The auditors shall then hold a closing meeting with the auditee and the auditees’
management where the lead auditor shall explain the results of the IQA. The agenda for the
closing meeting shall as per appendix 8.5. Attendance to the closing meeting shall also be
recorded.
6.3 Reporting of audits
6.3.1 The lead auditor/auditor shall prepare a final audit report in the format given in appendix
8.6 and submit it to the QMSM within five working (5) days of the audit and submit copies to
the auditee and / or auditee’s management.
6.4. Follow up audits
6.4.1 The audit team shall undertake the follow-up audit on the agreed date, complete the CAR
form and leave the auditee and / or auditee’s management with a copy of the CAR form as
the lead auditor carries the original for the QMSM to file.
6.4.2 The lead auditor/Auditor shall prepare a final audit report, which will be given to the QMSM
and a copy to the auditee and or auditee’s management.
6.4.3 The auditee and / or the auditee's management shall then undertake timely and effective
corrections and corrective actions to ensure that the NC does not recur.
6.4.3 Evaluation for the effectiveness of the corrective actions will be carried out in the following
audit and results filled by the auditor in the audit findings form
6.5 Maintenance of records
6.5.1 The QMSM shall analyze all the reports, summarize them and prepare a management
report.
6.5.2 The QMSM shall maintain all the original reports of all the internal quality audit reports while
the auditee and /or the auditee’s management shall maintain copies of the reports within
the audit areas.
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

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Internal Quality Audit Page 8 of 17 Pages

7. Documented information retained


a) Audit check lists
b) CAR forms
c) Audit reports
d) Audit findings
e) Audit plan
f) Attendance register
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

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Appendix 8.1 Process Map: Process map: EEP/QMS/CORP/SOP/O4/PM


Start

Prepare and distribute


Audit Schedule

Appoint Auditors

QMSM

Prepare audit plan

Lead auditor/auditor Prepare check lists

Perform
documentation/desk
audit

Perform site audit

Auditors review
3
meeting

NC No
identified?

1
YES
Raise CAR

Closing meeting

Complete CAR
form

2
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Are all
actions
taken?

Submit report to
MR

Maintain original
audit / CAR reports

1
End
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Location: QMSM Issue No. 1

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APPENDIX 8.2 AUDIT CHECKLIST FORM: EEP/QMS/CORP/SOP/O4/F1

EEP AUDIT CHECKLIST AUDIT NO.:


DATE:
FUNCTION/DEPARTMENT: AUDITOR:
AREA/SECTION: ESTIMATED AUDIT DURATION:
ACTIVITY/ASPECT TO BE AUDITED: AUDIT BASIS:

ISO 9001 Ref EEP documentation Remarks


(QM, Proc, WI) réf.
ASPECT/QUESTION
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
Location: QMSM Issue No. 1

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Appendix 8.3 Agenda for Opening Meeting


1) Introductions and recording of attendance
2) State the purpose/objectives of the audit
3) Mention the Basis/criteria of audit
4) Define the Scope/timetable of audit
5) Explain the Methodology of auditing
a) Desk audit
b) Sample questions from checklists
c) Interviews
d) Observations
e) Inspections
6) Define the communications Channels to be used.
7) Limit the language(s) to be used.
8) Confirmation of the following in the audit area (if necessary): -
a) Work safety
b) Emergency and security procedures.
9) Explain the closing meeting format.
10) State confidentiality (if necessary)
11) Request for resources (Room, Protective wear e.g. boots or coats)
12) Request for active support from the auditees and audit guides and explain their roles)
13) Explain the conditions under which the audit can be terminated.
14) Explain the appeal system on the conduct of the audit
15) A.O.B
ISO 9001:2015 QMS Doc. No. EEP/QMS/ CORP/SOP/O4
Location: QMSM Issue No. 1
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APPENDIX 8.4 AUDIT FINDINGS FORM: EEP/QMS /CORP/SOP/O4/F2


AUDIT No.:
EEP AUDIT REPORT DATE:
Function/department: Auditors:
Area/Section: Auditee Representative:
Activity/Aspect audited:
Details of activities; documents; methods; procedures; records; results and reports Obs. No.
examined during the audit; staff interviewed; operations witnessed, etc.

ISO 9001/QM/Proc Ref: Auditee/representative(sign)


AUDIT NON-CONFORMITY (S) (Nil reports required) Non-conformity No. Of

ROOT CAUSE ANALYSIS (how/why did this happen)

Auditee: (Sign): Auditor (Sign) Category: MAJOR MINOR

CORRECTIVE ACTION Officer responsible for action:

Date of completion: Auditee (sign): Auditor (sign):


FOLLOW-UP

EXTENT OF COMPLETION OF CORRECTIVE ACTION A


A: corrective actions fully completed B
B: corrective actions partially completed
C
C: no actions taken
Corrective actions carried out by (Name & Sign): Date:
Confirmed by Auditor (Name & Sign): Date:
Received and Approved by MR (Sign): Date:
EVALUATION FOR EFFECTIVENESS OF THE CORRECTIVE ACTION

Evaluated by (Name and sign): Date:


ISO 9001:2015 QMS Doc. No. EEP/QMS/ CORP/SOP/O4
Location: QMSM Issue No. 1

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Appendix 8.5 Closing meeting agenda

1) Introductions and recording of attendance


2) Vote of thanks for the exercise
3) Reconfirmation of: -
a) Audit purpose/objectives
b) Confirmation of audit Basis/criteria used
c) Confirmation or otherwise of audit Scope covered.
4) Audit findings
a) Positive
b) General observations
c) Nonconformities/gaps
5) Discussions on the audit findings
6) Auditors’ recommendations
7) Audit report
8) Follow-up audit
9) Confidentiality
10) Discussions (general)
11) A.O.B
ISO 9001:2015 QMS Doc. No. EEP/QMS /CORP/SOP/O4
Location: QMSM Issue No. 1

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APPENDIX 8.6 AUDIT SUMMARY REPORT: EEP/QMS/CORP/SOP/O4/F3

AUDIT SUMMARY AUDIT No.


Date:
Function/Department: Audit team No.
HOD/Auditee: Audit Team Leader:
Activity/Aspect audited:

SUMMARY OF AUDIT Number of Non-conformities

The summary should include positive statements about satisfactory performance, highlight any areas of
weakness, and reveal any non-compliance.

Due Date by which all corrective actions are


To be discharged (indicated by the Auditee only)

Signature of audit team leader Date Signature of HOD/Auditee Date


ISO 9001:2015 QMS Doc. No. EEP/QMS /CORP/SOP/O4
Location: QMSM Issue No. 1

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APPENDIX 8.7 AUDIT PLAN: EEP/QMS/CORP/SOP/O4/F4

Organization: ETHIOPIAN ELECTRIC POWER


Address: Mexico near KKARE Business Centre, P.O. Box15881, Addis Ababa
Audit Number:
Visit Due by Date: Actual Visit Date:
Lead Auditor:
Team Member(s):
Additional
Attendees and
Roles
Standard(s): ISO 9001:2015
Audit Language: English
Audit Scope: Development, Investment, Construction, Operation, Management
of Power Plants, Power Generation & Power Transmission
Audit Objectives: To determine conformity of the management system, or parts of it with audit criteria and its:
- ability to ensure applicable statutory, regulatory and contractual requirements are met,
- effectiveness to ensure the client can reasonably expect to achieve specified objectives
and to identify as applicable areas for potential improvement.

Date Time Auditor Organisational and Functional Units/ Processes and Key Contact
Activities
0830 Auditor arrives
0845 ALL Opening meeting with Management
0900

1030
1130
1300 ALL LUNCH
1400
1500
1600 Review of outstanding issues
1630 ALL Closing meeting with organizations management
1700 End of audit
ISO 9001:2015 QMS Doc. No. EEP/QMS /CORP/SOP/O4
Location: QMSM Issue No. 1

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APPENDIX 8.8 OPENING AND CLOSING MEETING ATTENDANCE RECORD


EEP/QMS/CORP/SOP/O4/F5

Name Position Opening Closing

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