Company Name:

Document No: SOP/QAC/ HO-09

የኢትዮጵያ መድሃኒት አቅራቢ ኤጀንሲ
Ethiopian Pharmaceuticals Supply Agency
Title: Effective date : 13/09/19
SOP for Internal Quality Audit
Rev. No.: 0 Page 1 of 7

CONTENTS PAGE FOR DOCUMENT CONTROL

USE ONLY
1. INTRODUCTION 2
2. PURPOSE 2
3. SCOPE 2

4. RESPONSIBILITY 2

5. PROCEDURE 3

6. FORMS 15

7. AMENDMENT HISTORY 15

REPARED BY APPROVED BY

Name: QA team Name:

Signature: Date: Signature: Date:

 Page 2 of 7

1. INTRODUCTION
EPSA conducts internal audits at planned intervals to evaluate the quality management system conforms
to ISO 9001:2015 requirements as well as EPSA’s own requirements for its quality management system.

For the purpose of this document in addition to the definitions given in ISO 9000:2015 the following
definitions shall be used.

 Quality audit: A systematic and independent examination to determine whether quality activities
and related results comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
 Auditor: A person with the competence to conduct an audit.
 Auditee: Function being audited.

Abbreviations

FLW: Flowchart
EPSA: Ethiopian Pharmaceutical Agency
OP: Operating Procedure
OF: Operating Form
QAH: Quality Assurance Head
NC: Non Conformity
NCR: Non-conformance Report

2. PURPOSE

The purpose of this procedure is to define the method to under take quality system audit in all aspects of
the quality system described within the Quality Manual and associated procedures and Instructions to
ensure compliance to all documented system requirements, initiate corrective actions and verify its
clearness by follow-up audit.

3. SCOPE
This procedure applies to all system audits undertaken within EPSA.

4. Responsibility
Quality Assurance Head

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Internal Quality Audit,
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 Page 3 of 7

5. PROCEDURE
5.1 Flowchart
Input Process Output Responsibility
1. Appointed Audit team 1. QAH
1. Annual Plan/audit leader
program

2.Audit Schedule
2. Audit team leader
2. Defined audit objective
scope & criteria
3. Audit team leader
3. Audit objectives scope &
criteria 3. List of Audit Team
Members
4. Audit team leader
4.List of Audit team
members 4. Agreed tentative audit
dates
5. Defined scope objectives
& criteria
5. Auditor
6.Reviewed document
6. Audit Criteria
6. Audit team leader
5. Document review report
6a, Reviewed document 6a Audit team leader
6a Audit suspension report
6b, Previous audit report
6b. Auditor

6b. Draft audit plan

7, Draft Audit Plan
7, Audit team leader

7. Approved Audit
8, Approved audit plan plan 8, Audit team leader

9, Working documents
8. Receipt of plan
acknowledgement 9, Auditor& Audit team
10, Audit finding leader
9. Audit Finding
10, Auditor
11. Draft audit report
10. Draft Audit report
11, Audit team leader
12. Approved Audit
Report 11. Approved Audit Report
12, Audit team leader
12. Audit report receipt
Acknowledgement

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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 Page 4 of 7

5.2 Description of process steps

FLW Process Steps
1 The QAH initiates the quality audit by assigning the audit team leader and fix mutually
convenient time schedule.
2 The QAH and the audit team leader define the audit objectives, scope & criteria. The audit
objectives define what is to be accomplished by the audit and the audit scope describes the
extent and boundaries of the audit.

3 The audit team members are selected taking in to account the competence needed to achieve the
objectives of the audit and hence comprise personnel qualified as auditors. The audit team leader
decides the size and composition of the team.
4 The QAH formally contacts the auditee to make arrangement for the audit and to provide in
formation on the proposed timing.
5 The auditee documentation such as quality management system documents records and previous
audit reports are reviewed to determine its conformity with audit criteria, before conducting the
actual audit.
6 Additional description is not required
6a The internal quality audit process is suspended if major NC is identified, until rectification.
Conditions of suspension:
 Audit criteria is not communicated for implementation
 The audit criteria is communicated only less than a month for implementation
6b The auditor prepares the audit plan to facilitate scheduling and coordination of the audit
activities.
The audit plan include the following:-
a) The audit objectives and scope;
b) The audit criteria and any reference documents;
c) The date and places where the audit is to be conducted ;
d) The expected time and duration of the audit, including meetings with the auditee
management and audit team meetings;
e) The responsibilities of the audit team members;
The audit team members prepare and organize working documents according to their audit
assignments. The working documents may include:-
 Checklists and audit sampling plans and
 Forms for recording information.
7 The audit plan is reviewed and approved by the Audit team leader and gets acceptance by the
auditee management.

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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 Page 5 of 7

5.2 Description of process steps

FLW Process Steps
8 The approved audit plan is distributed to the auditee at least a week before the audit activities
begin.
9 An opening meeting is held with the auditee’s management or where appropriates those
responsible for the functions or processes to be audited. The purpose of the opening meeting is:
- to confirm the audit plan
- to provide a short summary of how the audit activities will be undertaken
- to confirm communication channels, and
- to provide an opportunity for the auditee to ask questions
From the audit team member's personnel independent of those having direct responsibility for
the process/activity being audited conducts the audit.
Information is collected with interviews, examination of documents and observation of activities
and conditions in the area of concern.

Information gathered with interview is tested by acquiring the same from other independent
sources, such as physical observation, measurement and records. Clues suggesting non-
conformities are noted if they seem significant even though not covered by checklists. When
non-conformities are identified it is agreed with the auditee.
The auditee determines the causes of the identified and agreed non-conformities and their
respective corrective action(s)
Closing meeting is held with the auditee for the following purposes:
i) To present the final results, main findings.
ii) To give a positive feedback to those workers who contribute towards the quality system.
iii) Offering the opportunity to respond to the principal findings.
The implementation and effectiveness of the corrective actions are taken by the auditee with
in an agreed time frame.
The auditee shall follow the status of the corrective action and inform the Management
Representative. Subsequently the QAH shall assign the auditor to under take follow-up audit.
The completion and effectiveness of corrective actions shall be verified by the follow up audit
or be part of the subsequent audit. Other wise the NC report file remains open.

10 The auditor shall prepare the audit report that include:

 Objectives and scope of the audit
 Identification of audit team leader and members
 The dates and places where the audit activities were conducted

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Internal Quality Audit,
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 Page 6 of 7

 The audit criteria

 The audit finding
 The audit conclusions
 The audit plan
Audit reports shall be clear, concise and legible and supported by objective evidence.

11 The audit team leader shall review and approve the audit report for completeness and clarity.
12 The approved audit report shall be distributed to recipients according to the distribution list and
with in the agreed time period.
The audit team members, those responsible for managing the audit and all report recipients shall
respect and maintain the confidentiality of the contents of documents, any other information
obtained during the audit, and the audit report.
All draft working documents pertaining to the audit shall be retained or destroyed by the QAH.

5.3 Supplements to the process steps

5.3.1 At least twice a year, all elements of the Quality System must be audited against documented
requirements to ensure compliance. These audits are scheduled by the QAH and, unless otherwise
indicated.
5.3.2 All non-conformities shall be addressed in a timely manner and corrective actions shall be
implemented to ensure compliance to ISO 9001:2015 standard, documented procedures, work
instructions and Quality Manual.
5.3.3 Results of all internal audit reports shall be submitted for the management review.
5.3.4 Auditors shall possess personal attributes to enable them to act in accordance with the principles
of auditing. Auditor should be open-minded and mature; possess sound judgments; analytical skill
and tenacity; have the ability to perceive situations in a realistic way, to understand complex
operations from a broad perspective, sincere, honest & discrete, diplomatic decisive, act and
function independently while interacting effectively with others and to understand the role of
individual units within the overall organization.

5.3.5 Personal traits of an auditor shall include the following:

Desirable
 Good outward impression - appearance and conduct;
 Intelligent - alert, understanding, well spoken and reasoning;
 Emotionally stable - clam, self-confident, persistent, insistent, task orientated, resilient;
 Good character - honest, reliable constructive, helpful and diplomatic, patient, sober, discreet;
 Good attitude - values, interest, work habits, initiative, careful, curious and open-minded,
unbiased, attentive, observant.
Undesirable
 Poor outward impression - undisciplined, opinionated and argumentative;
 Lacks intelligence - injudicious and gullible;
 Emotionally unstable - bad tempered, lazy, unsure, depressive;

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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 Page 7 of 7

 Bad character - dishonest, impatient, unreliable;

 Poor attitude - easily persuaded, inferiority complex, needs popularity.
5.3.6 Questioning is employed in order to ensure that the facts presented are indeed correct and that
they are a true reflection of the operations. The main tool an auditor may use during questioning is
using open questions or closed questions according to the circumstances. When starting the audit,
open questions should be employed in combination with good listening techniques. The auditor
will use closed questions when he/she wishes to obtain concrete and focused facts.

6. FORMS

Document Number Document Title

OF/QAC/HO-29 Annual Audit Program Preparation Form
OF/QAC/HO-30 Internal Quality Audit Planning Form
OF/QAC/HO-31 Non-conformance Report Form
OF/QAC/HO-32 Internal Quality Audit Report Form
OF/QAC/HO-28 Corrective Action Planning Form

The QAH has the responsibility to retain and maintain the following records:
 Audit schedule
 Audit report
 Corrective actions taken

7. AMENDMENT HISTORY

AMENDMENT HISTORY
Rev. No. Description of Change Originator Effective Date
0 Initial Release QMS Task Force 13/09/19

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Internal Quality Audit,
Please make sure that this is the correct issue before use SOP/QAC/ HO-09, 0, 13/09/2019