In search of better Health

KEMRI

STANDARD OPERATING PROCEDURE

FOR
ADDRESSING RISKS AND
OPPORTUNITIES
 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 2of15

 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 3of15

Table of Contents

1. INTRODUCTION ........................................................................................................... 4

2. SCOPE ....................................................................................................................................... 4

3. PURPOSE .................................................................................................................................. 4

4. DEFINITIONS .......................................................................................................................... 4

5. RESPONSIBILITIES ............................................................................................................... 5

6. MATERIALS AND EQUIPMENT ....................................................................................... 5

7. PROCEDURE ........................................................................................................................... 5

7.1 Risk identification........................................................................................................ 6

7.2 Risk classification ........................................................................................................ 7

7.3 Risk analysis ................................................................................................................ 8

7.4 Risk evaluation ............................................................................................................ 8

7.5 Risk mitigation .......................................................................................................... 10

7.6 Record your findings and implement them ......................................................................... 10

7.7 Regularly review risk assessment and update if necessary ............................................... 11

7.8 Opportunities ........................................................................................................................... 12

8 REFERENCES: ...................................................................................................................... 12

Appendix 1: RISK ASSESSMENT FORM .................................................................................... 13

 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 4of15

1. Introduction
Managing risks is something we all do every day, mostly without even thinking about it.
When the complexity increases beyond our everyday experiences, such as risks faced by a
business or a big project, a more formal approach is needed. Risk-based thinking enables an
organization to determine the factors that could cause its processes and its quality
management system to deviate from the planned results, to put in place preventive controls to
minimize negative effects and to make maximum use of opportunities as they arise

2. SCOPE
This procedure applies all actions that will be taken to address risks and opportunities in the
Institute.

3. PURPOSE
This SOP provides a practical guide for addressing risks and opportunities in accordance
with ISO 9001:2015 requirements to continually improve KEMRI Quality Management
System (QMS). The purpose of carrying out risk assessment is to identify the significant
hazards, risks and opportunities that may be present in a work area and to determine actions
or controls required to ensure that the risks associated with these hazards are either
eliminated or reduced to an acceptable level for all those workers who might be exposed.
It is essential that these workers are given appropriate information, instruction and training to
ensure all work activities are conducted as safely as possible.

4. Definitions

KEMRI- Kenya Medical Research Institute

ISO International Organization for Standardization

SOP- Standard Operating Procedure

QMS- Quality Management System

Risk is the effect of uncertainty and such uncertainty can have positive or negative effects.
 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 5of15

Risk assessment -is a careful examination of what, in the workplace, could cause harm to
people, so that the employer can weigh up whether he or she has taken enough precautions or
should do more to prevent harm.

Controlling risk -means that the employer (as the law requires) does all that is reasonably
practicable to ensure that a hazard will not injure anyone (e.g. by eliminating the hazard,
enclosing it in a totally enclosed container, using general or local exhaust ventilation,
implementing safe operating procedures, or providing personal protection, as a last resort).

Hazards - are situations with the potential to cause harm.

Opportunity can arise as a result of a situation favourable to achieving an intended result.

5. Responsibilities
4.1 Director KEMRI
4.2 Deputy Directors
4.3 Assistant Directors
4.4 Centre Directors
4.5 Head of Departments
4.6 All staff

6. Materials and Equipment

6.1 Risk assessment form

6.2 Evaluation of Risk and Identification of Measures to Control Significant Hazards
Form

7. Procedure

When planning for the quality management system, KEMRI shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 of ISO 9001:2015 standard and
determine the risks and opportunities that need to be addressed to:

Figure 1 gives the framework for managing risks and opportunities at Kenya Medical
Research Institute
 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 6of15

Figure 1: Risk Management Framework

7.1 Risk identification

It is important to start by establishing the context what activities are we talking about?
What are you trying to do? e.g., using a piece of machinery, making/building something,
budgeting, collecting measurements, importing or exporting goods, staff, data analysis and
reporting.

An important aspect of risk assessment is to accurately identifying the potential risks in the
institute. What might affect the outcome? e.g., a weather event, change to regulations,
 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 7of15

injury, staffing shortages, lack of required skills, loss of a key supplier, chemical exposure,
theft, fraud, computer failure, human error.

7.1.1 Risk identification shall include any action taken with the aim of identifying risk
including opportunities within the institute.
7.1.2 Several tools and methodologies may applied in risk and opportunities identification
such as the SWOT/SCOT analysis, PESTEL, Audits, Inspections, brain storming,
Observations, Customer feedback, Customer surveys etc.
7.1.3 Risk assessment form will be used to record the risk identified amongst other details.

7.2 Risk classification

It is important to identify potential risks and hazards specific to work place activities. They
may be classified as:-

a) Operational e.g. loses/profits, data safety, lack of adequate funding etc

b) Biological e.g. pathoges and molds

c) Chemical e.g. expired chemicals, misuse/mishandling of chemicals such as

formaldehyde, ethylene oxide, glutaraldehyde, and paracetic

d) Physical hazards that may lead to injury e.g. falling

e) Ergonomic - Are risk factors found in jobs requiring repetitive prolonged exertions or
prolonged awkward postures causing musculoskeletal disorders (MSD) e.g. Pipetting,
patients, working in cold and boiler rooms

f) Mechanical - Involves machines or processes: If equipment is not properly installed or

maintained it may; Cause a fire or Electrical safety. Compressed gases or liquids can
also be considered a mechanical hazard

g) Psychological - Violence or aggression from patients, visitors, residents, staff and

clients could take the form of physical, emotional and/or mental abuse. Stress due long
working hours. Trauma working with very sick/dying patients
 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 8of15

7.3 Risk analysis

Risk analysis is carried out in order to prioritize them. Important questions to ask include;
What are the consequences if the risk actually occurs? How likely is it to occur? e.g. minor
injury, loss of life, schedule delays, change to reputation, financial losses/gains, business
growth/closure

Risk (R) is often described quantitatively as a product of severity (S) and Probability (P) of an
event i.e. R=SxP. Severity can be described as impact or consequence or effect of an
occurrence while probability can described as likelihood/ or chance of an occurrence. Impact
rating and severity is presented in table 2.

Table 1: impact Description

Impact Impact Risk or Hazard Severity Definition

rating (severity)

Exposure of the business to such a risk is likely to lead to internal

1 Low inefficiency or consumer disappointment, disgust and complaint but
no severe effect

Exposure of the business to such a risk is likely to lead to loss of

2 medium
customers or mild INJURY or litigation

Exposure of the business to such a risk is likely to lead to

3 High SIGNIFICANT business losses or SEVERE INJURY or JAIL
SENTENCE or DEATH

7.4 Risk evaluation

This may involve asking ourselves can we live with this risk? is it a minor inconvenience?
Major problem? Fantastic opportunity? Whats our risk appetite? risk averse? Risk
seeking? Neutral? How could we change the consequences or change the likelihood? Weigh
up the cost/benefit balance for different options.
 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 9of15

7.4.1 This will require the experienced judgement or subjective evaluation of the assessor.
7.4.2 For each potential hazard identified, assess the associated level of risk by combining
a) The consequence of the risk in the event of occurrence, (i.e. the level of harm that
could theoretically be realised) and, b) The likelihood of risk occurring (assume
existing control measures are in place).
7.4.3 Express risk as high, medium, low, or effectively zero using the risk matrix
table 3.

Table 2: Estimation of risk

 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 10of15

7.5 Risk mitigation

7.5.1 Having identified the risk and opportunities its important to determine how likely it
is that risk will occur, i.e. the level of risk and the things you need to do to manage
them responsibly. During risk mitigation you actually implement what you decided
should be done to control the risk! e.g. changes to work practices or extra monitoring
to watch out for triggers
7.5.2 Risk assessment should only include what you could reasonably be expected to know
you are not expected to anticipate unforeseeable risks.
7.5.3 Look at what youre already doing and the control measures already in place. Ask
yourself:
a) Can I avoid the risk?
b) Can I eliminate the risk?
c) Should I take the risk in order to pursue an opportunity
d) Is it possible to change the likelihood or consequences
e) What about sharing the risk or;
f) If not, can I retain the risk by an informed decision.

7.6 Record your findings and implement them

7.6.1 Make a record of your significant findings the risks and opportunities, risk register
in appendix 1 will be used.
7.6.2 A risk assessment must be suitable and sufficient, i.e. it should show that:
a) A proper check was made;
b) you asked who might be affected;
c) You dealt with all the obvious significant risk,
d) The precautions are reasonable, and the remaining risk is low;
e) You involved your employees or their representatives in the process.
f) If your risk assessment identifies a number of risks, put them in order of
importance and address the most serious risks first.
 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 11of15

A good plan of action often includes a mixture of different things such as:

7.6.3 A few cheap or easy improvements that can be done quickly, perhaps as a temporary
solution until more reliable controls are in place;
a) Long-term solutions to those risks most likely to cause accidents or ill health;
b) Long-term solutions to those risks with the worst potential consequences;
c) Arrangements for training employees on the main risks that remain and how they are to
be controlled;
d) Regular checks to make sure that the control measures stay in place; and
e) Clear responsibilities who will lead on what action, and by when.

NOTE: As you complete each action, tick it off your plan.

7.7 Regularly review risk assessment and update if necessary

7.7.1 Review your assessment on an ongoing basis to make sure you are still improving, or
at least not sliding back.
7.7.2 The assessment should be reviewed at least annually. However, the assessment must
also be reviewed where necessary, amended when significant changes to the work
activities occur, following the introduction of new legislation or guidance or
following an incident or accident which highlights deficiencies in the assessment
7.7.3 Review is done mainly to verify if;
- the control is it working?
- Can we do better?
- Has anything changed?
- Does this risk still apply?

Risks should be reduced to the lowest reasonably practicable level by taking preventative
measures, in order of priority. Do not simply jump to the easiest control measure to
implement.
 KENYA MEDICAL RESEARCH INSTITUTE

DOCUMENT TITLE: SOP for Addressing Risks and Opportunities

REF NO: KEMRI/QMS/SOP/ARO/001 Version: 01 PAGE: 12of15

7.8 Opportunities

Taking Opportunities may involve;

a) Adopting new practices,

b) Launching new products,
c) Opening new markets, branches, sites
d) Addressing new customers
e) Building partnerships
f) Using new technology
g) Any other desirable and viable possibility

8 References:

Reference Document Title

No.
7.1 KS ISO 9001:2015-Quality Management Systems-Requirements
Appendix 1
KENYA MEDICAL RESEARCH INSTITUTE
RISK ASSESSMENT FORM
Centre\Department\: ___________________________

QMS F021

Date Identified Risk Probability of Severity (S) Mitigation measure

( List Significant occurrence (Low, Medium,
Risks/ Hazards) high)

Name of Assessor: ________________________ Date _____________________

Reviewer: ______________________________ Date __________________

Annex to KEMRI/QMS/SOP/ARO/001 Version 1

Appendix 2
KENYA MEDICAL RESEARCH INSTITUTE
RISK REGISTER
QMS F022

Location: Date:
Hazard/Ri What is the What is What is How What How will the controls
sk/ harm/ the the effective further be implemented?
opportunity likelihoo level of are the controls
opportuni
that the d that risk? current are When
ty Action Due
hazard/risk the harm controls required Complet
R=LC by Date
could would ? ? ed
cause? occur?

Annex to KEMRI/QMS/SOP/ARO/001 Version 1

Appendix 3: Example of assessing how things go wrong and action taken

Annex to KEMRI/QMS/SOP/ARO/001 Version 1