Risk Management and training for Pharmaceutical Hazards by Dipankar. what are the risk in case of Hazards and how this is Managed

1. Dipankar
Patra 1
RISK MANAGEMENT
AND TRAINING
HAZARD ANALYSIS

2. While training needs to be conducted realistically
and to standard, it must also be carried out safely.
The key to achieving safety in training and
administration is risk management. Risk
Management (RM) is a systematic process that
identifies the relative risk of training
requirements. It weighs risk against training
benefits and eliminates unnecessary risk that can
lead to accidents.
2
INTRODUCTION

3. Risk management can be applied in all situations and
environments. Its application enables trainers at the
various levels to achieve the following:
• Conserve lives and resources and avoid unnecessary
risk
• Make informed decisions to implement a course of
action
• Identify feasible and effective control measures
when specific standards do not exist
• Provide reasonable alternatives to accomplishing a
task without compromising safety and standards.
3
OBJECTIVES

4. 4
RISK MANAGEMENT PROCESS
Risk Management is the process of
identifying, assessing, and controlling
hazards to conserve resources.
The five steps are:
1. Hazard identification—The process begins
with the identification of hazards that have
the potential of causing injury to personnel,
damage to equipment or structures, loss of
material, or reduction of ability to perform
a prescribed function.
2. Hazard assessment—The second step is
hazard assessment. Here, the objective is to
determine the potential impact of a hazard
on the training. There are two major
considerations. One is probability—how
likely the hazard is to cause loss; the other
is severity—how severe that loss will be.

5. 3. Risk control options and decisions—The third step includes
creating as many risk control options as possible and then selecting
those that best control risks without significantly impeding the
training objectives. (As a guide, an instructor responsible for
executing training should be authorized to make decisions at the
risk level (low, moderate, and high). Extremely high authorization
should be held at the jurisdictional/agency authority level.)
4. Risk control implementation—The fourth step involves the
integration of risk controls into standard training procedures,
training plans, training directives, lesson plans, or instructions.
5. Supervision and evaluation—The fifth step, effective
supervision, assures sustained effectiveness of risk controls.
Instructors have responsibilities to supervise and enforce
performance according to standards
5
RISK MANAGEMENT PROCESS

6. 6
BENEFITS
 By fully integrating risk management into the training
system, instructors can expect the following benefits:
• Major improvement in training safety—Risk
management has the potential to improve safety without
any adverse impact on training effectiveness.
• Significant improvement of training realism—Risk
management has procedures that allow instructors to
detect these ineffective or overly restrictive risk controls
and eliminates or modifies them. The result is much safer
and significantly more realistic training.

7. 1. Quick risk assessment—This technique is used when the task or
activity to be performed is simple or straightforward and there
is little time available for planning.
2. Deliberate risk assessment—This technique is used for tasks
or activities that are moderately complex or with significant
risks. Time is available for planning and detailed coordination
is required to ensure smooth execution of the tasks/activities.
3. In-depth risk assessment—This method is used when the tasks
or activities involved are complex, large scale or high risk. It
requires input from experts and ample time is available for
detailed planning and coordination, which may involve several
parties
7
TYPES OF RISK ASSESSMENT

8. The risk management process of improving safety in training starts
with hazard identification.
To facilitate hazards identification in training, the interrelated
factors—man, machine, medium, management, and task—can
influence the outcome of the training conducted.
• Man—Reviewing the proficiency, psychology, and physiology of
the individual
• Machine—Reviewing the adequacy of design and maintenance
aspects of the equipment/technology used
• Medium—Reviewing the environmental conditions (i.e. weather
and terrain) and the effects of environment to the task •
Management—Reviewing the planning/preparation and control
aspects of the task
• Task—Reviewing the clarity and compatibility aspects of the task
HAZARD IDENTIFICATION

9. Preliminary Hazard Analysis/ Preliminary List Techniques
The Preliminary Hazard Analysis/List (PHA/PHL) is a core hazard
identification technique that is used in virtually all hazard analyses.
It is based on the task analysis and is a listing of the hazards
associated with each stage of the task. The PHA/PHL is often
developed on a worksheet for each step of the task; it is usually the
simplest form of analysis that is needed to identify hazards.
Scenario Creation Technique
The scenario creation technique can stand alone or be used as a
component part of other techniques. It involves the mental
appreciation of the flow of events or scenario that can be expected
in a task. The user of the scenario creation technique visualizes the
task twice: first as it is intended to go—then again with what can
go wrong affecting the task. Normally, the events are visualized in
a time sequence from the beginning of the task to the end.
9
HAZARDS IDENTIFICATION TECHNIQUES

10. “What If” Technique :
This technique involves the use of the “what if” question applied to specific segments of the
system (“What if the engine fails to start?”) The likely results are defined followed by a
determination of the possible causes of the misfired round.
Task Accident Analysis :
This technique involves the use of past patterns of accidents to determine the likely sources of
future accidents. By focusing on actual patterns of past losses, the instructor is more likely to
prevent recurrences and, in doing so, drastically decreases future losses.
Interview Technique
The interview technique is a versatile technique. The basic form of the interview technique is
the face-to-face interview. These interviews can be highly structured, designed to elicit
specific information from the interviewee or very unstructured, targeted at incidents of
opinions. The individual interviews can be rolled up into overall totals to get an insight into
the status of the entire organization.
Cause and Effect Technique
This technique is similar to the Total Quality Management (TQM) toolbox. It is a tool that
completes hazard identification to either demonstrate the positive or negative outcome. It
normally involves a variety of other investigative and analysis techniques. 10
HAZARDS IDENTIFICATION TECHNIQUES

11. Controls options are developed to either eliminate the hazards or
reduce the risks. Hazards that cannot be eliminated must be
controlled.
Controls can be taken in three main forms:
• Educational Controls—These controls are based on the
knowledge and skills of the learners. Effective control is
implemented through individual, collective and continuous
training that ensures currency and performance to standard.
• Physical Controls—These controls may take the form of barriers
to warn learners that a hazard exists. In addition, safety
controllers may be appointed.
• Avoidance—These controls are applied to prevent personnel
from contacting identified hazards or getting into hazardous
situations. 11
DEVELOP CONTROL OPERATIONS AND RISK
DECISIONS

12. For the controls to be effective, each control developed
must meet the following criteria:
• Suitability—It must remove the hazard or reduce the
residual risk to an acceptable level.
• Feasibility—The individual or organization must have
the capability to implement the control.
• Acceptability—The benefit gained by implementing the
control must justify the cost in resources and time. The
assessment of acceptability is largely subjective. It could
be based on the following criteria for determining
acceptability of controls for each identified hazard.
12
CRITERIA FOR CONTROLS

13. Supervision
During the execution, the instructor must monitor the controls to ensure that they remain
effective and, when necessary, modify them. The instructor should also anticipate,
identify, and assess new hazards and implement new controls. Variable hazards such as
fatigue, equipment, serviceability, and the effects of environment should also be
monitored.
Evaluation
Controls integrated into training or operation need to be evaluated to determine their
effectiveness. After the training, instructors need to evaluate how well the risk
management process was executed.
This includes:
• Determining how to ensure that successes are continued/carried on into the next task
• Capturing and disseminating lessons learned
• Considering the effectiveness of the risk assessment in identifying and accurately
assessing the probability and severity of hazards
• Evaluating the effectiveness of each control in reducing or removing risk
• Determining why some controls were ineffective and what should be done when the
hazard is encountered again
13
SUPERVISION AND EVALUATION

14. • Lewis, H.W. 1990. Technological Risk. W.W. Norton &
Company. New York.
• National Fire Protection Association. Recommended Practice
for Disaster Management, NFPA 1600. Quincy, MA: NFPA, 1995.
• Burby, R.J. “The Technical Feasibility of Risk Analysis”,
Chapter 7 of Sharing Environmental Risks: How to Control
Governments' Losses in Natural Disasters. Boulder, CO:
Westview Press, 1991. pp. 129-153.
• Mitchell, J.K. “Human Dimensions of Environmental Hazards:
Complexity, Disparity, and the Search for Guidance”, Chapter 6
of A. Kirby, ed.
• Nothing to Fear: Risks and Hazards in American Society.
Tucson: University of Arizona Press, 1990.
• Palm, R.I. Natural Hazards: An Integrative Framework for
Research and Planning. Baltimore: Johns Hopkins University
Press, 1990.
14
REFERENCES