Hazard and Risk Man

agement
Presented by:
Yadav Pooja .S.
Roll no. 47
Mpharm Q.A Ist yr ( sem II)
Sub : Hazard and Safety
Management

Mahatma Gandhi Vidyamandir's Pharmacy College, Panchavati,

Nashik
 Table of Content

1. Self Protective Measures

2. Critical Training
3. Process of Hazard Management
4. ICH guideline on Risk Assessment and Management Methods
5. Preliminary Hazard Analysis
6. Factory Act and Rules
7. Fundamentals of Accident Prevention
8. Elements of Safety Programme and Management
9. Physicochemical Measurements of Effluents
10. BOD, COD
11. Determination of Some Contaminants
12. Effluent Treatment Procedure
13. Role of Emergency Services.
 Introduction

A shark in the sea - Swimming with a

Hazard shark - Risk
Hazard + Exposure
 Types of Workplace Hazards
a. Safety Hazards– ex. Electrical hazards, wet floor, fire

b. Biological Hazards- virus, bacteria, fungi, parasites

c. Chemical Hazards- cleaning agents, insecticides, pre
servatives, etc
d. Physical Hazards- high temperature, vibration, radia
tion
e. Ergonomic Hazards- wrong posture and movements
while working
f. Psychological Hazards- anything that can cause stres
s. Ex. Workloads, fears or phobia, etc.
 Principles Of Quality Risk
Management
• Two primary principles of quality risk managemen
t are:
i. • The evaluation of the risk to quality should be
based on scientific knowledge and ultimately lin
k to the protection of the patient; and
ii. The level of effort, formality and documentation
of the quality risk management process should b
e commensurate with the level of risk.
Self Protective measures ag
ainst workplace hazards
Reporting hazards and developing solutions that improve saf
ety and health.
 Analyzing hazards in each step of routine and non-routine jo
bs, tasks, and processes.
 Defining/documenting safe work practices.
Conducting site inspections.
Developing and revising safety procedures.
Participating in incident and close call/near miss investigatio
ns.
 Serving as trainers for current coworkers and new hires.
Developing, implementing, and evaluating training programs
.
Critical Training For Risk
Management
• Critical Employee Training
1.Develop comprehensive training courses
2.Monitor participation in training
3.Assess training effectiveness and continuo
usly improve.
Process of Hazards Management
 Process Of Hazards Manageme
nt
Step 1: Identification
Step 2: Risk Assessment
Step 3: Controls
1. Eliminate
2. Isolate
3. Minimize
Step 4: Monitor and Review
ICH Guidelines On Risk Assessment And
Risk Management Methods And Tools Qual
ity Risk Management
• QUALITY RISK MANAGEMENT Q9
• This Guideline has been developed by the appropr
iate ICH Expert Working Group and has been subje
ct to consultation by the regulatory parties, in acc
ordance with the ICH Process.
Risk Assessment
• Risk assessment consists of the identification of h
azards and the analysis and evaluation of risks ass
ociated with exposure to those hazards (as define
d below). Quality risk assessments begin with a w
ell-defined problem description or risk question
 Risk Management Methods And
Tools
• Basic risk management facilitation methods (flowchart
s, check sheets etc.)
• Failure Mode Effects Analysis (FMEA)
• Failure Mode, Effects and Criticality Analysis (FMECA)
• Fault Tree Analysis (FTA)
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Preliminary Hazard Analysis (PHA)
• Risk ranking and filtering
• Supporting statistical tools.
Preliminary Hazard Analysis
Conducted to identify potential hazards and prioritize th
em according to the :
(1) probability of an accident or injury being caused by t
he hazard.
(2) severity of injury, illness or property damage that co
uld result if the hazard caused an accident.
• PHA can serves 2 purposes :
(1) it can expedite bringing the new system on line, but
at a substantially reduced risk of injuring workers.
(2) it can serve as a guide for a future detailed analysis.
• Experience and related expertise are important factor
s in conducting a preliminary review.
FACTORY ACT AND RULES 40.
• 40. Safety of buildings and machinery
• 40A. Maintenance of buildings.
• 40B. Safety Officers.
• CHAPTER IV-A PROVISIONS RELATING TO HAZARDOUS PROCESSES
• 41. Power to make rule to supplement this Chapter
• 41A. Constitution of Site Appraisal Committees.
• 41B. Compulsory disclosure of information by the occupier.
• 41C. Specific responsibility of the occupier in relation to hazardous
processes.
• 41D. Power of Central Government to appoint Inquiry Committee.
• 41E. Emergency standards.
• 41F. Permissible limits of exposure of chemical and toxic substance
s.
• 41G. Workers' participation in safety management.
• 41H. Right of workers to warn about imminent danger
 FUNDAMENTALS OF ACCIDENT PR
EVENTIONS
Three essential ingredients in any Organization.

1.MAN
2.MACHINE
3.MATERIAL
These form three angle of a triangle with Managem
ent at center to control them. It is essential that this
triangle is an equilateral triangle, maintaining the es
sential equilibrium.
• What is accident ?
• An unintended, unplanned event which has the potentia
l to cause harm or injury. An incident which causes harm
or has potential to do so
• Injury is the result of completion of 5 dominos
• 1. Social Environment.
• 2. Fault of the person
• 3. Unsafe Action / Unsafe Condition
• 4. Accident
• 5. Injury
Causes of Accidents
 Direct Causes

Unsafe Act Unsafe Condition

Operating without authority
Bypassing Safety devices
Operation at unsafe speed
Using wrong tool
Not using ppe
Working on moving
equipment
Ungraded machine
Defective Condition of
tool
Unsafe method of
storing ,piling
Inadequate Ventilation
Improper house keeping
 Indirect causes

Physiological Psychological Lack of Knowledge

unsuitability's Unsuitability's and Skill
•Negative attitude
•Poor eye sight towards safety
•Hard to •Ignorance of safety rules
hearing and procedures
•Frustration and conflict
•Intoxicated Morals
•Physiological •Individual differences
disabled Acclimatization
•Motivation and
Aspiration
 Elements of Safety Program and Mangement
Safe Plant
Plant hazard assessment
Daily inspection regime
Proactive maintaenance Regime
Plant & equipment SOP's

Safe plant

Safe
Safe environmen
operator t

Safe Operator Safe environment

Operator training Site inspection and hazard review
Operator Competency High level job task review
General safety knowledge WHS management plan
Site specific knowledge Manage high risk activites
Physiological measurements o
f Effluents
 BOD: Biological Oxygen Demand
• Biological oxygen demand (BOD), also known as bioc
hemical oxygen demand, is a bioassay procedure that
measures the dissolved oxygen (DO) consumed by ba
cteria from the decomposition of organic matter.
• Biological oxygen demand is an important water qual
ity parameter because it greatly influences the conce
ntration of DO that will be in the water. The Q-value c
urve for BOD used in calculating a water quality index
2 illustrates the relationship between BOD and water
quality—the higher the BOD, the lower the water qu
ality, with 0 to 2 mg/L being associated with high wat
er quality and values greater than 10 mg/L being asso
ciated with low water quality
COD: Chemical Oxygen Demand

• The COD (Chemical Oxygen Demand) test represen

ts the amount of chemically digestible organics (fo
od). COD measures all organics that were biochem
ically digestible as well as all the organics that can
be digested by heat and sulfuric acid. It is used in t
he same applications as BOD. COD has the advant
age over BOD in that the analysis can be complete
d within a few hours whereas BOD requires 5 days
. The major drawback of the COD test is the prese
nce of hazardous chemicals and toxic waste dispos
al.
Determination of Some Conta
minants
• 1.Liquid chromatography
• 2.Mass spectrometry
• 3.NMR Spectra
• 4.UV Spectra
• 5.Microscopic Technique
• 6.IR spectra
Effluent Treatment Procedur
e
Waste Water Treatment
Role of Emergency Services

• The Emergency Control Organization is responsible

for:
* Implementing emergency procedures as prescribe
d in the Emergency Plan & Procedures
* Ensuring that all personnel within their area of re
sponsibility are trained for their role in an emergenc
y
* Reporting any matters likely to affect the viability
of the Emergency Plan & Procedures
* Checking on the effectiveness of emergency syste
ms and equipment
References
• ICH harmonized tripartite guideline QUALITY RISK MAN
AGEMENT Q9 Current Step 4 version dated 9 November
2005
• OSHA Safety and Health Program Management Guideli
nes November 2015 Draft for Public Comment
• HLTHMAN, volume 20 part 8 CHAPTER 2 WASTE WATER
TREATMENT
• Emergency Control Organization Commercial Services &
Development, November 2013
• National Science Foundation. Water Quality Index. 200
4.
• A textbook of Hazards and Safety Management by Deep
anti Gajjar, Dr. Usman, Sanjay Nagdev,Dr. Sonawane pu
blished by pee vee books.
Thank You !!!