Company Name:

Document No: SOP/QAC/ HO-02

የኢትዮጵያ መድሃኒት አቅራቢ ኤጀንሲ
Ethiopian Pharmaceuticals Supply Agency
Title: Effective date : 13/09/19
SOP for Control of Records
Rev. No.: 0 Page 1 of 9

CONTENTS PAGE FOR DOCUMENT CONTROL

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

4. RESPONSIBILITY 2

5. PROCEDURE 3

6. FORMS 9

7. AMENDMENT HISTORY 9

PREPARED BY APPROVED BY

Name: QA team Name:

Signature: Date: Signature: Date:

 Page 2 of 9

1. INTRODUCTION
Records are documents stating results achieved or providing evidence of activities performed.
Generally records need not be under revision control.

For the purpose of this document in addition to the definitions given in ISO 9000:2015 the following
definitions apply:
 File: An organized unit of documents accumulated during current use and kept together
because they deal with the same subject and activity.
 Indexing: The process of establishing and applying terms or codes to records, to be used to
retrieve them and to search for and analyze information in records across classifications or
categories.
 Non- paper records:

 Photographic prints and transparencies

 Motion picture films
 Sound records

Abbreviations

FLW: Flowchart
EPSA: Ethiopian Pharmaceutical Supply Agency
SOP: Standard Operating Procedure
OF: Operating Form
DC: Documentation Center

2. PURPOSE
The purpose of this document is to establish the method by which records are identified, indexed,
filed, retained, maintained, stored, accessed and disposed.

3. SCOPE
This procedure applies all functions of EPSA to manage records.

4. Responsibility
All Functions of EPSA

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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 Page 3 of 9

5. PROCEDURE
5.1 Process flowchart

INPUT PROCESS OUTPUT RESPONSIBILITY

1, Internal and 1, Received and 1, Secretaries
external records/ verified document for
documents completeness
Records
2, Registered records 2, Secretaries
2, Records

3, Record, Records 3, Verified file index 3, Secretaries

Index 4a, Filled records 4a, Secretaries
4a, Records Index

4b, Indexed Record 4b, Secretaries

4b, Clause 5..3.1 of
this document
5, Labeled file with 5, Secretaries
5, Clause 5.3.1 of unique identification
this document code

6, Clause 5.3.1 of 6, Constructed file 6, Secretaries

this document

7, Clause 5.3.1 of 7, Filled records 7, Secretaries

this document

5.2 Description of process steps

FLW Process Steps Description
1 Before receiving records shall be checked for legibility, cleanness and completeness.
2 Records shall be registered as soon as they are created or received.
3 Additional description is not required.
4a All quality records shall be physically or electronically filed by a method, which enhances
accessibility and retrieval by a user. If electronic files are used a buck-up system or other
suitable measures shall be used to prevent record loss.
4b Additional description is not required.
5 Additional description is not required.
6 If there is no previous file, a new file shall be created.
When a new file is created the following steps shall be followed:
 Allocate classification, titling and indexing to the record
 Physically construct the file

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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 Page 4 of 9

7 Additional description is not required.

5.3 Additional description to the process steps

5.3.1 Structure of a file system
5.3.1.1 File categories
All files shall be organized into logical groups, which relate to the functions and activities of the
organization.
Records in a filing system shall be categorized as follow:
a) First level category - identifies the functions
Categorize the records based on the specific main dirctorates/services and these are designated by
two uppercase English Alphabets as Follows.
 DG = Director General
 CO = Capacity Building and Operational Research
b) Second level category - Identifies the record
Two digit numerical codes starting from 01 to 99 shall be assigned to each process/activity
identified in each Second level category.
c) File serial number - Identifies the specific file (volume)
Every file shall be allocated a file number clearly identifying the year of creation (European
Calendar).

d) File Coding System other than Financial Records

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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The First Level Category

Main Functions/Directorates Code in two letters
DG
The Second Level Category
01 Records Classification Code

Font size 28

No. of Volumes

01 No. of box files in consecutive no. within the same category

Year Calendar Year the File Created

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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e) File Coding System for Financial

Records

Main Function
(Finance Directorate)
FD
Financial Records Classification Code
Records
Code
Indicate records serial number (the beginning and the end)
Record Serial Number

Indicate the period in which the records have been created

Period

Location of Location from which the records have been created (Head Office
Records
Created
Volume
No. Box File Volume Number

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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5.3.2 Closing Files

a) When a process/an activity associated to the file are terminated, the file shall be closed using
Form No. OF/DG/11.

b) When a file becomes full, it shall be closed using Form No. OF/DG/11 and a new file
shall be created. The active part of the file shall be available for use.

5.3.3 Storage of files and non-paper records

 All files and non-paper records shall be stored in an environment that ensures protection
of the records from any forms of deterioration and loss.
 Changes shall not be made on records with out prior authorization (approval)
 All confidential /access controlled records shall be stored in locked steel file cabinets. The
record identification codes shall be indicated on the file cabinets to ensure easy and quick
retrieval.
 All other files shall be placed on wooden or metallic shelves made for this purpose and
non-paper records shall be stored in suitable packages.

5.3.4 Indexing
Based on the second level category, index shall be prepared for easy and quick retrieval of
records. Indexes shall be visibly posted near the records storage area.

5.3.5 Access control

All confidential records shall be handled and stored confidentially and the access to such records
shall be approved (using Form No. OF/QA/HO-09 by the respective Functional Heads.

Access controlled records

S/N Access Controlled Records Reasons for Access Location Authorized

Controlled Persons
1 Customer Proprietary To protect the customers In the respective Functional Heads
Records proprietary records and Functional Heads and records
avoid business threat Custodian
2 Personal Records To protect personal Central Archive HR Director
 Medical reports information (Provisions of
 Personnel appraisal Declaration of Human
records Rights)
 records of disciplinary
action
 Biographic data
3 Financial and Asset To protect from alteration Finance Specified by the
Records and lose Directorate Finance Director
 Receipts
 Journal Voucher
 Asset Registers

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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 Payment Voucher
 Filled Earning Cards
 Ledgers
 Controlling Account
Records
 Declaration Records

Note:
 Authorized persons have an access to confidential records without any prior approval of their
access and they have the responsibility to maintain the confidentiality of such records;

5.3.6 Records retention time

S/N Records On Site (Short term) Long Term Retention

Retention Time Time
1 Distribution Records Product expiry date 10 years
2 Employees’ records including personal As long as the employee Life time
files exists in the organization
3 Performance Reports 3 10
4 Procurement Records 3 10
5 Fixed Asset and Financial Records 5 10
6 Financial Audit Report 3 Life time

a) As soon as the short-term retention time expires, records shall be transferred to the long term
storage room.
b) Records under legal case shall be retained until the case is finalized even if the long-term retention
time has been expired.
c) Records may be retained after the long-term retention time if they are required to preserve
knowledge.
d) If the above records are available in an electronic media the backups shall be properly labeled and
retained longer time.

6.3.7 Disposal of records

Records shall be disposed of as soon as their retention time is expired. Head of the Central Archive
and Heads of the Records Custody have the responsibility to dispose of the records up on approval
by the management representative using the disposal reporting format.

6. FORMS

Document Number Document Title

OF/QAC/09 Records Accessing Form
OF/QAC/10 File Movement Control Form
OF/QAC/11 File Closing Form
OF/QAC/12 Files Registry Form

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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OF/QAC/13 In-coming Records/Documents Registration Form

OF/QAC/14 Out-going Records/Documents Registration Form
OF/QAC/15 Documents and Records Classification and Index

Records Custodians have the responsibility to maintain the identified records.

7. AMENDMENT HISTORY

AMENDMENT HISTORY
Rev. No. Description of Change Originator Effective Date
01 Initial release QMS Task Force 13/09/2019

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Records,
Please make sure that this is the correct issue before use SOP/QAC/HO-02, 0, 13/09/2019