CARIRI CONTROlltO DOCUMtN1

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MANAGEMENT OF CHANGE

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STANDARD OPERA TING PROCEDURE

FOR THE

MANAGEMENT OF CHANGE
(MOC)

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Approved by: Chief Executive Officer . . . . . . . . . .. . . . . . . .. . . . . .. .................

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DOCUMENT CHANGE HISTORY

CAR.SOP.03

Date of
Pg# Section Comment/Reason for C ha nge Brief Description of Change
Change

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1.0 PURPOSE
To establish a procedure for managing the submission, review, evaluation, categorization,
approval, and authorized execution of all changes which are relevant to both the QMS
and the HSE Management System. This procedure ensures that no changes are made to
the organisation's personnel, equipment, materials and processes, without a review of the
associated risk and proper authorisation.

2.0 SCOPE
This procedure covers proposed changes within the Institute including but not limited to
its activities, processes, personnel, materials and equipment wh ich have the capability to
affect the organisation or the delivery of the service to the client (see Appendix I).
Changes related to documented information are addressed in the procedure for the
Control of Documents (CAR.SOP.0 I).

3.0 RESPONSIBILITIES
3. 1 The C.E.O is ultimately responsible for the final approval of all requested changes that
are to be made to the QMS, the HSE and its documentation as per this procedure.

3.2 Executive Management is responsible for:

• Providing the necessary resources and support to ensure that there is an effective
change management process. This includes the relevant expertise for planning and
managing the change introduced.

• Ensuring that this process for the management of change is implemented and adhered
to by all persons within the organ isation.

• Ensuring that risk is managed effectively and that any risk which is adjusted or
introduced as a result of any change is minimal.

• Verifying and granting final authorisation to re-start changed process, where

applicable.

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3.3 The Head, Quality Services and HSE Department, both have the overall
responsibility for:
• Management of the change process as it relates to the management systems which
they govern including:
a) Changes to the QMS:- The Quality Services Department
b) Changes to the HSE Management System:- The HSE Department
• Receipt and logging of a change request, the scheduling of meetings to evaluate the
change, the submission of recommended changes for approval to the CEO, and
ensuring that all approved changes within their scope are appropriately implemented,
managed, monitored and reviewed.
• Keeping records of copies of completed Management of Change Forms and revised
Risk Assessments on file.

3.4 All Section Heads are responsible for:

• The identification of the need for possible changes and the submission of a
completed Change Request Form.
• Assisting in the Change Management process.
• Actively participating in the plann ing, management and execution of the various
activities done to ensure changes are effectively managed and documented.

• Keeping records of copies of their respective completed Management of Change

Forms and revised Risk Assessment on file.
• Communicating/Posting the change and the revised risk to workers who may be
affected.

3.5 The Change Management Team is responsible for:

• The overall evaluation of all requested changes as per this procedure. This includes,
but is not Iimited to the review of the change, the associated risk and other possible
impacts that it might have.
• Making recommendations for approval of the change, but additional improvements
where necessary.

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4.0 REFERENCES
4. 1 ISO 900I : 20 15 Standard - Section 8.5.6 Control of Changes
4.2 Business Process Manual Section 6.0 - Planning Process
4.3 STOW-TT Guidance Manual- Element 3.5

5.0 DEFINITIONS
5. 1 Change: Anything that transforms, alters, modifies or deviates from the agreed
approach/process/place/ competence etc. It also includes any situation wh ich can affect
the associated risk, its management and exposure (as identified in the risk assessment).

5.2 The Change Management Team:

a) This is the team responsible for the review, evaluation and recommendation of all
requested changes prior to approval and execution.
At minimum, the team shall always consist of the fol lowing persons:
• Person requesting the change
• The Process owner, or designate
• A Quality Officer
• A Safety Officer

b) One or more of the following departmental representatives will be included

dependent on the change being evaluated:
• Human Resource
• Facilities Maintenance
• Info rmation Technology
• Procurement, and
• Any other representative that can provide expertise in the change being evaluated.

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6.0 PROCESS
6. 1. INPUT
A Change Request Form is completed and submitted along with any relevant attachments.

6.2. OUTPUT
• A reviewed and approved Change Request Management Form
• Other supporting documentation, where needed, to effect the change

6.3 . PROCESS
The desired change, idea fo r improvement or a solution to a problem can be identified by
anyone associated with the process. Once identified it should be brought to the attention
of the Section Head who will initiate the process as described below.

6.3. 1 COMPLETION AND SUBMISSION OF A CHANGE REQUEST:

a) A Change Request Form is completed, signed, and then submitted to the Quality
Services Department by the Section Head or Executi ve Management.
b) Upon receipt, the request is recorded in the Change Management Log
(CAR.LOG. 02) and an MOC Request number is assigned.
c) The request is submitted, within one working day to Executi ve Management fo r an
approval to proceed and returned to the Quality Services Department.
d) Once an approva l to proceed is obtained, contact is made with all relevant persons
required fo r the Change Management Team and they are informed of the date, time
and location of the review meeting.
e) All requests shall be schedu led for and be reviewed within 5 working days of the
receipt of an approval to proceed.

6.3.2 REVIEW AND EVALUATION OF THE REQUESTED CHANGE:

a) A review and evaluation of all requested changes shall be conducted by the Change
Management Team at the scheduled time and date. Attendance shall be recorded.

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b) The Team shall consider, discuss and document the fo llowi ng, as a minimum,
CAR.SOP.03

during the review.

• The purpose of any potential consequences of the change
• Any Risks (potential or updated) associated with the change
• Potential effects on the integrity of the QMS/ HSE Management Systems
• The availability of the required resources, and
• A proposed Action Plan including all mandatory requirements such as
document updates, the allocation or re-allocation of responsibilities, training
requirements, facility adjustments, personal protective equipment
requirements, etc.
c) At the end of the review, recommendations for the change are obtained from the
Change Management Team and forwarded to the CEO.

6.3.3 APPROVAL OF A CHANGE REQUEST:

a) Only requests which have previously been reviewed by and received a
recommendation by the Change Management Team shall be accepted for final
authorization.
Note: Sectfons "A " and "B " must be completed and all pertinent in.formation should be
attached.
b) Upon receipt, the CEO shall review and make a decision on the requested change to
either:
1. Reject the request for the change
11. Provisionally accept the change, requesting further information
111. Accept the request for the change. Where authorization is granted, a period of
review for the effectiveness of the change is determined.
c) The completed form is returned to the Quality Services Department for processing
where all decisions and review dates are logged. A checkl ist is compi led and sent to
the relevant Section Head.
d) Only authorized changes can be implemented.

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6.3.4 IMPLEMENTATION AND MONITORING:
a) Upon receipt of authorization, the Section Head is responsible for developing a plan for
effecting the change, communicating, implementing, continuously monitoring the change
and participating in al l fo llow-up reviews.
b) A review of the change is conducted within the pre-determined timeframe and its
effectiveness is determined. This is led by either the Quality/ HSE representative
according to the change being made.
c) If deemed ineffective, the possible root cause is determined and suitable correction is
agreed upon and taken within the specified time and the result recorded.
d) If required, a fo llow-up review is conducted and the effectiveness of the corrective action
is reviewed.
e) If the change is still not effective, a recommendation is decided upon as to whether or
not:
1. The changeover should stop
11. More time is requ ired for implementation,
111. To revert to previously documented action unti l issues can be rectified.
f) All recommendations, at this stage, are to be submitted to the CEO for determination.

7.0 RELATED DOCUMENTED INFORMATION

• Control of Documents (CAR.SOP.OJ)
• Change Request Form (CAR.F.05)
• Change Request Management Form (CAR.F.06)
• Change Management Log (QSD.LOG.02)
• Recommendation Sheet (QSD.F.06)

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APPENDIX 1-

TYPES OF CHANGES WHICH CAN INTRODUCE OR ALTER ASSOCIATED RISKS

TYPE of CHANGE EXPLANATION

This can be the introduction of new equipment, replacement of old equipment.
EQ UIPMENT
upgrading/modi fi cation of old equi pment, re location of equipment.

ENVIRONMENT This includes changes to the location and other environmenta l conditions.

This includes changes with respect to competence, skill , etc (ability to safely
PERSONNEL
execute task) . This also includes changes to who is involved.

PLANT C hanges made to the fl ow, connections, design, strength and qua lity etc.

C hanges made to the standard approach/ sequence used to execute the task, or in
PROCESS
how to operate the equipment being used etc. must include legal changes

C hanges made to the type o f chemical inc ludi ng its properties, quantity,
constitutio n, hazardous nature.
MATERIAL/SUBSTANCES A change may not be considered where there is a " replacement in kind". For
example, where the change meets the design specification o f the o ri ginal or a
provis ion that maintains the original intent and fu nctioning o f the original
process, etc.

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