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Poppet Diaper Manufacturing PLC,

Address: Sheger City, Gelan
Phone Number:+25196800002
Oromia, Ethiopia
Poppet Diaper Document Change Control SOP
Manufacturing Name
PLC Issue date 22/03/2024 Approved Date Effective date 25/03/2024

Document SOP/PDM/CCP 22/03/2024 Next revision 24/03/2027

Number date

1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to ensure that changes affecting the
quality management system are reviewed, approved, and documented and provides instructions
for the initiation and approval of systems, process, materials, products and producer changes.

2. Scope
This SOP is applicable for the change control system in order to establish a systematic approach
for notification, evaluation and implementation of changes in operating procedures, quality
management system, product, and process.

3. Responsibility
Change initiator: initiates any changes and provides for change initiator department with
change control form.
QA officer: Responsible for the review of the proposal to evaluate the impact of change initiator
to recommend and forward it to QA.
Head QA: To review the impact of change, classification of change, Planning for
implementation of change control and to proposed changes and approve and reject the change
control.
General Manager: approves if any employees initiate changes about the quality management
system.

Prepared by Reviewed by Approved by

Signature
Designation Document officer Manager- Quality Officer Manager - Quality Assurance
Logo
Poppet Diaper Manufacturing PLC,
Address: Sheger City, Gelan
Phone Number:+25196800002
Oromia, Ethiopia
Poppet Diaper Document Change Control SOP
Manufacturing Name
PLC Issue date 22/03/2024 Approved Date Effective date 25/03/2024

Document SOP/PDM/CCP 22/03/2024 Next revision 24/03/2027

Number date

4. Definition
Change control: is a set of controlled actions used to manage modifications to processes,
systems, or documents that may impact the quality management systems in the company.
Change: any additions to, deletion of, or modifications to a system, process, materials, products
or procedures.
Major change: change which cannot be classified as a minor change or which may affect the
critical attributes of a system, facility, apparatus, material/product or procedure/process.
Critical change: means any change that impacts/affects the quality of Product; quality
management systems or impacts the regulatory requirements and needs urgent reporting
requirements to the respective departments.

5. Procedure
a. Initiation of changes:
 Any employee from any departments may request change/change initiators, but shall
pass through the change initiator teams when a change to any working documents are
required.
 Any change initiators/requester will complete a change request control form and shall
submit for change initiator team.
 A change consisting of the department name and a chronological number assigned and
tracked by each department head will be assigned to the request.
 The change initiator shall forward, the duly filled and signed change control along
with enclosures to the head of department/designee for evaluation and approval.
Prepared by Reviewed by Approved by
Signature
Designation Document officer Manager- Quality Officer Manager - Quality Assurance
Logo
Poppet Diaper Manufacturing PLC,
Address: Sheger City, Gelan
Phone Number:+25196800002
Oromia, Ethiopia
Poppet Diaper Document Change Control SOP
Manufacturing Name
PLC Issue date 22/03/2024 Approved Date Effective date 25/03/2024

Document SOP/PDM/CCP 22/03/2024 Next revision 24/03/2027

Number date

 For all major & critical changes (If required) the QA shall prepare a change
implementation plan where applicable and that shall be enclosed with change control.
b. Approval of change by initiators:
 The QA head of department/designee shall review the feasibility of change with
respect to the proposal and its reason for the change, risk assessment, and supporting
documents.
 If the proposed change is not feasible, the head of the department/designee shall reject
the change after consulting the change initiator.
 If any additional information/justification is required from the initiator, change control
shall be returned to the initiator (reconsideration) with comments by the head of the
QA department/designee for correction.
 If the proposed change is feasible / found satisfactory, the head of the QA
department/designee shall enter their consent (regarding the impact on their documents
/activities/system), and approve the change, so the change control will be proceed for
next course of action.
c. First level evaluation of change control by QA:
 Designated QA personnel shall review the change control and attached documents for
correctness.
 If the change request needs further clarification or justification, then the filled form
shall be returned to the initiator (reconsideration) for corrections.
 If change control is acceptable, designated QA personnel shall assess the impact of the
proposed change (primary assessment) as per predefined parameters in the change

Prepared by Reviewed by Approved by

Signature
Designation Document officer Manager- Quality Officer Manager - Quality Assurance
Logo
Poppet Diaper Manufacturing PLC,
Address: Sheger City, Gelan
Phone Number:+25196800002
Oromia, Ethiopia
Poppet Diaper Document Change Control SOP
Manufacturing Name
PLC Issue date 22/03/2024 Approved Date Effective date 25/03/2024

Document SOP/PDM/CCP 22/03/2024 Next revision 24/03/2027

Number date

control.
d. Second level evaluation of change control by Impact Assessment Team:

 After completion of the primary assessment, change control shall be forwarded to the
Impact Assessment Team (IAT) for their review and comments along with
responsibility.
 IAT shall be decided, based on the recommendation from the change initiating, and
impact assessment shall be done.
 After receipt of comments from IAT, the designated QA person shall review the
comments and forward to head QA for further approval of comments.

e. Review by QA:
 Designated QA personnel shall review the comments made in the change control by
the IAT team and evaluate all content before the approval of head QA on change
control.
 Head QA put their comment in change control and classifies the change as
minor/major/critical.
f. Approval of change control:
 Head QA shall review the comments made in the change control.
 Head QA shall approve/reject the change as per their assessment.
 QA Head shall put their comment in change control.
 After head QA approval, change control shall be shared (if applicable) to the staff for
review, and final approval before implementation of the proposed change.
Prepared by Reviewed by Approved by
Signature
Designation Document officer Manager- Quality Officer Manager - Quality Assurance
Logo
Poppet Diaper Manufacturing PLC,
Address: Sheger City, Gelan
Phone Number:+25196800002
Oromia, Ethiopia
Poppet Diaper Document Change Control SOP
Manufacturing Name
PLC Issue date 22/03/2024 Approved Date Effective date 25/03/2024

Document SOP/PDM/CCP 22/03/2024 Next revision 24/03/2027

Number date

 Changes after approved by the quality assurance head, training shall be given for the
responsible departments and staffs and training certificate shall be recorded.
 Change control shall be recorded and maintained.

6. Reference
 ISO 13485:2016: Medical devices- Quality management systems

 EFDA SoP

7. Document Distribution
This SoP shall be distributed to
 Quality assurance department
 Document control officer
 Production manager

Prepared by Reviewed by Approved by

Signature
Designation Document officer Manager- Quality Officer Manager - Quality Assurance
 Logo
Poppet Diaper Manufacturing PLC,
Address: Sheger City, Gelan
Phone Number:+25196800002
Oromia, Ethiopia
Poppet Diaper Document Change Control SOP
Manufacturing Name
PLC Issue date 22/03/2024 Approved Date Effective date 25/03/2024

Document SOP/PDM/CCP 22/03/2024 Next revision 24/03/2027

Number date

Annex-I Change Control Request Form

General Information Form No
Requestor Name Signature Date
Requestor department
Change priority Very High High Medium Low
Change descriptions and details
Describe the current situation (a problem, an opportunity or a new
Current Situation: need – why is there a need for a change in the project?>

Desired Situation: Describe the desired situation. What is the goal and benefits of this
change request?

Impact or Risks: Describe the impact or risks of not implementing this change. If this
impact or risks can be quantified, then this can help with the analysis
Prepared by Reviewed by Approved by
Signature
Designation Document officer Manager- Quality Officer Manager - Quality Assurance
 Logo
Poppet Diaper Manufacturing PLC,
Address: Sheger City, Gelan
Phone Number:+25196800002
Oromia, Ethiopia
Poppet Diaper Document Change Control SOP
Manufacturing Name
PLC Issue date 22/03/2024 Approved Date Effective date 25/03/2024

Document SOP/PDM/CCP 22/03/2024 Next revision 24/03/2027

Number date

(cost benefit analysis) and final decision regarding the implementation

(or not) and the priority of this change.
Out of Scope: Clarify what is out of the scope of this change request. This clarifies
further the boundaries of the requested change and ensures that only
the needed change is implemented.

Quality Assurance Approval Approve Reject Date Signature

Top Management Approval Approve Reject Date Signature

Prepared by Reviewed by Approved by

Signature
Designation Document officer Manager- Quality Officer Manager - Quality Assurance