Ministry of Health

Division of Community Health

MOH Afya Headquarters, Cathedral Rd.
APPROVAL OF SOPs USED IN CHP SCOPE OF WORKP.O Box 30016– 00100
AT HOUSEHOLDS’ IN KENYA
NAIROBI
Item Title Names SOPAffiliate
No: 001 Signature Date
Institution (dd-mm-yyyy)
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents JKUAT
1. Author/s Committee of 1. Prof. Simon
Experts (COE) Karanja
Effective Date: 21st November 2023 Supersedes: None
drawn from MOH at 2. Kipkerich Bera MOH-NPHL
National and Stephen
Counties, JKUAT &
Partners 3. Peter Mwangi MOH-NPHL

4. Daniel Otieno FIND KENYA

5. Caroline MOH Afya HQ

Cherotich
2. QA Expert from MOH 1. John Wanyungu MOH Afya HQ
Review Division of
2. Beth Gikonyo MOH Afya HQ
Community Health
3. Approving Head; Division of Dr. Maureen Kimani MOH Afya HQ
Authority Community Health

1.0 Purpose.

1.1 This procedure defines the pathways for creating, revising and executing document control
processes, records including sanitation, testing related, treatment linkages and data management in
accordance with necessary legal, policy frameworks and CHP Quality Management System in
place.

2.0 Scope.

Division of Community Health CHP-SOPs Page 1 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

2.1 This SOP Shall inform compliance and consistency with CHPs scope of work, and also serve to
standardise the processes of carrying Division of Community Health Management and Control of
Documents and records in use.

3.0 Abbreviations.

3.1 CHP – Community Health Promoters

3.2 QA - Quality Assessment Scheme
3.3 SOP- Standard Operating Procedure.
3.4 QMS – Quality Management System
3.5 N/A – Not Applicable
3.6 CHO – Community Health Officer
3.7 CHA – Community Health Assistant

4.0 Definition of terms

4.1 Technical procedures –documented processes of carrying out laboratory examinations in a
systematic way.
4.2 Documents- Media that defines processes, procedures, and responsibilities for achieving quality
objectives.
4.3 Records- Written or electronic information that is evidence if the completion of a task or activity.
They provide evidence that work was done or that a result was obtained.
4.4 Form- A paper or electronic document on which information or results are captured. Once a form
is completed it becomes a record.
4.5 Document Master List and Control Index- A list which details all documents and forms that relate
to the quality management system including details about their revision status and distribution
location.
4.6 Document control- A mechanism of ensuring that only the latest versions of approved documents
are available for use as a resource and that obsolete documents are removed from use and may
only be utilised as reference points.
4.7 Wet-Ink documents – Original documents developed, authorized by official signature by the
accountable office within the stipulated QMS
4.8 Quality Management System – Set of documented processes and procedures with evidence that is
functional, self-regulating and sustainable in providing quality services.

5.0 Responsibilities.

Division of Community Health CHP-SOPs Page 2 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

5.1 This SOP applies to all CHP personnel implementing promotive and preventive healthcare at
household level
5.2 It is the responsibility of CHP to ensure that they read, understand, attest to SOPs and consistently
follow the policies and procedures as described herein.
5.3 The CHO/CHA implementing community health strategy including support supervisory,
mentorship and coaching of CHP.
5.4 All documents (manuals and SOPs) are reviewed by the DCH or designee to ensure the systems
and procedures defined meet the requirements of Legal and applicable policy guidelines
supporting CHP scope of work
5.5 The Division of Community Health or designee has the responsibility of approving developed
documents and SOPs.
5.6 Wet Ink signatures on document developers shall be blue colour, QA review black colour and
MOH-DCH Head approval and authorization brown color
5.7 All original documents with wet-ink signatures in both electronic (read only pdf) and hard copies
shall be kept in document master file at the Division of Community Health under lock and key
with electronic versions with password access
5.8 QA Officers at the Division of Community Health shall have access rights and custody of
document master file hard and electronic read only pdf version copies (MOH-DCH/CHP-
001Vol.1A/2023)

6.0 Principle

6.1 Document control process is a quality management system practices that align all CHP documents
in sync with executable functions, ensuring that organizations maintain consistency, accuracy, and
compliance in their documentation.
6.2 Standard Operating Procedures (SOPs) for document control typically follow defined processes
creating effectiveness to manage and regulate the creation, review, approval, distribution, and
archiving of obsolete documents.

7.0 Materials and Equipment

7.1 Seal and official CHP Stamp
7.2 Printer and toners
7.3 Rim papers
7.4 Pen and ink

8.0 Performance of procedure

Division of Community Health CHP-SOPs Page 3 of 12
 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

8.1 N/A

9.0 Sample required

9.1 N/A

10.0 Methods and procedures.

10.1 Documentation of quality manuals, system procedures and procedures.

10.1.1 Documentation of quality manuals, system procedures and procedures used in the CHP
shall be developed, reviewed and approved as described in the document MOH-DCH
001 Preparation and Maintenance of SOPs.
10.2 Forms and exhibits
10.2.1 These shall be used to document that activities related to implementation of the CHP
household activities that have been carried out.
10.2.2 The development of forms and checklists may be done by any Division of Community
Health personnel designated or assigned the task.
10.2.3 Final approval for use shall be given by the Head of Division of Community Health or
the designee personnel.

10.3 Assigning document control numbers

10.3.1 Document Master List, document catalogue or Control Index shall be based on modular
agreed numbering system:
a. Quality Management Systems - 000
b. Water Sanitation and Hygiene (WASH) -100
c. Community assessment, measurements and referrals. – 200
d. Point of Care Testing (RDT for screening of diseases) – 300

Division of Community Health CHP-SOPs Page 4 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

e. Integrated community case management - 400

f. Nutrition. – 500
g. Biosafety -600
h. ICT/Data Management - 700

10.3.2 The WASH SOPs shall start with abbreviation of Ministry of Health and Division of
Community Health; example of their 1st SOP shall take identity number as follows;
Hand Washing Hygiene SOP No. MOH-DCH 101
10.3.3 After development and review, all manuals, system procedures, CHP procedures, forms
and exhibits shall be assigned document number that are generated and listed in
Document Master List, document catalogue or Control Index
10.3.4 Generation of the document’s numbers shall be done according to thematic scope as
organized by COE.
10.3.5 Document master list shall provide the identification with the following attributes:
a. Provide for document identity through unique

10.4 Amendments/changes to documents

10.4.1 All the documents shall be reviewed every two years or when need arises to make sure
that they are up to date and reflects current practice.
10.4.2 When the documents no longer reflect current practice, the DCH or designee ensures
that it is revised and that the version number and revision date are documented
appropriately.
10.4.3 If there are no changes made during the review period, it must be documented in the
document revision history that no changes were made.
10.4.4 After revised versions are approved, communication regarding the changes is done to
all CHP and if required, re-training may be done to ensure that all staff are up to date.
10.4.5 Hand-written changes are not permitted on all manuals, procedures and processes.
However when records have been created on forms, hand-written changes may be done.
10.4.6 Changes to hand written records are made by adding additional information or if
information is to be deleted, this is done by striking through the wrong entry with a
single line. The correct entry is written just on top or in front of the wrong entry. The
person making changes signs or writes their initials and date of the amendment.
10.4.7 Correction fluid (white out) must NEVER be used on DCH documents.
10.4.8 All changes to manuals and quality system procedures are done only through the DCH
or designee as follows.

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 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

a. The DCH or designee ensures that changes to documents are affected on all
copies of the document or record.
b. All amendments made to documents are recorded on the document revision
history.
c. The document goes through the full approval process and a new version
number is issued by the Division of Community Health or designee.
d. MOH-DCH-001: Document Master List and Control Index is updated
accordingly.
10.5 Documents of external origin
10.5.1 External documents may be by downloaded from online sources, purchased or received
from independent institutions including donors.
10.5.2 The purpose of these documents is to act as reference points or educational materials.
10.5.3 A list of all these documents is maintained in MOH-DCH-001: Document Master List
and Control Index and they are also given external document control numbers, defined
location in MOH-DCH and purpose.

10.6 Use of electronic and hard copy documents

10.6.1 The Head of Division of Community Health or designees are the main custodians of
original hard copies of all approved documents and electronic versions of the same.
10.6.2 Original documents signed by hand is known as ‘wet ink’ including the SOP Master
and Document Control SOP
10.6.3 The Original shall be filled under lock and key in MOH-DCH/CHP Vol.001/2023 as
Document master file
10.6.4 Obsolete documents also have an electronic folder maintained by the Head of Division
of Community Health or designees.
10.6.5 Access to the computer(s) with electronic documents is password protected.
10.6.6 It is envisioned that repositories of electronic documents may be maintained in cloud
services e.g Microsoft Office 365, Google Drive or Dropbox, where such cloud services
can be effectively controlled using user names and passwords. This shall be
implemented in liaison with Division of Digital Health Ministry.
10.6.7 Hard copies of approved documents shall be availed at relevant work stations and used
as reference points by all personnel working on Community health services.

10.7 Distribution of documents

10.7.1 The Head of Division of Community Health or designees have the mandate to distribute
documents for use in the required areas.

Division of Community Health CHP-SOPs Page 6 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

10.7.2 Information on the locations where documents are distributed shall be maintained in
MOH-DCH 001: Document Master List and Control Index and also be indicated in the
distribution log that accompanies the respective documents.
10.7.3 Only copies of original versions (signed and approved) are distributed. These copies are
assigned a copy number through serialization linear numbering. i.e. the first copy is
copy number 1 and so forth.

10.8 Storage and access to documents and records

10.8.1 Approved hard copy documents and records are stored in files that are clearly labelled
with:
a. Identification name of the contents.
b. Date range (e.g. from Date dd-mm-yyyy to Date dd-mm-yyyy).
c. Name of the CHP region where applicable.
d. File number as indicated in MOH-DCH 001: Document Master List and
Control Index.
10.8.2 All records are kept on designated shelves or cabinets in the respective units. These
records are secured by ensuring that access is limited to authorised personnel.
10.8.3 Only authorised Division of Community Health personnel are issued with passwords to
enable them access electronic records.
10.8.4 Any external party requiring access to the CHP records for any purposes shall seek
written authority from the Head of Division of Community Health or designee.
10.8.5 Visitors, interns and students (unauthorized access) are oriented and supervised or
accompanied during their stay to ensure data security and patient information
confidentiality.
10.8.6 Signing of confidentiality declaration form for access of data and ensuring patient
information are used in accordance with ethical principles that govern

10.9 Contingency Plan

10.9.1 All documents need to be backed up in a way that allows them to be accessible even
when electronic systems are unavailable. An external hard drive, compact drive (CD),
removable flash drive or secure cloud service is acceptable.
10.9.2 Electronically stored information, such as previous document versions and approval
information should also be backed up appropriately.
10.9.3 Access to electronic backups shall be limited to authorised personnel

Division of Community Health CHP-SOPs Page 7 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

10.9.4 Backup systems should be tested at least quarterly to assure functionality and data
integrity.

11.0 Retention, recalling and disposal of obsolete documents

11.1.1 When new versions of documents have been approved for use and put into effect, the
superseded or obsolete document are recalled or collected from all sites where they
were distributed. This shall be done by the QAO, or designee.
11.1.2 Recalled documents or records that need archiving are filed in clearly labelled MOH-
DCH archive files.
11.1.3 Retention periods for documents and records are detailed in Annex E or as guide by
Medical records Archiving and disposal Act.
11.1.4 After the archival period, the documents are destroyed by shredding and subsequent
incineration or burning.
11.1.5 Authorisation to dispose documents or records shall be given by the Head of Division
QAO, or designees and this shall be done in writing.
11.1.6 Disposal of medical records shall be done based on Kenyan medical disposal
regulations and guidelines.
12.0 Procedural notes
N/A

13.0 References.

13.1 ISO 15189:2012

13.2 https://slmta.org/resources
13.3 http://resources.psmile.org/reso

Appendices
13.4 Appendix A: Document change history.
13.5 Appendix B: SOP Distribution log.
13.6 Appendix C: SOP Training Attestation Log.
13.7 Appendix D: SOP Training Log for Personnel Files.
13.8 Appendix E: Retention period for various documents

Division of Community Health CHP-SOPs Page 8 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

Appendix F: Data backup testing tool

1. Annex 1:
Revision History

Superseded Revisions done and/or

Review date; nature of changes and Reviewer’s
Version QA Review
(DD-MM-YYYY) reason/s or rationale for name
number change

None N/A 1. Original document

1. N/A

Division of Community Health CHP-SOPs Page 9 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

11.0 Annex-2

Total No. of Copies: 4 Distribution date:17-01-2022

Location No. of Type of copies:
copies Hard copy Soft copy
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

Distribution

Division of Community Health CHP-SOPs Page 10 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

Division of Community Health CHP-SOPs Page 11 of 12

 Ministry of Health
Division of Community Health
MOH Afya Headquarters, Cathedral Rd.
P.O Box 30016– 00100
NAIROBI
SOP No: 001
Title: SOP for Management and Control Version: MOH-DCH-001/2023
of Documents

Effective Date: 21st November 2023 Supersedes: None

Annex:1

2. SOP attestation after training and orientation on both supervisory and community health promoters’ scope of
work that embodies this Standard Operating Procedure that shall ensure that all safety PPE use are guided by
this document. Attesting that you have been taken through the SOP and you understand the utilization and
compliance by signing as an evidence of acceptance.

S/No. Official Names of CHP Date of SOP Date of reading and Signature
CHP Identification Training/Orientation proof of compliance
No. the SOP

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

Division of Community Health CHP-SOPs Page 12 of 12