Hazard and risk management of quality assurance (QA) 2 SEMESTER 1 year OF HAZARDS AND SAFETY MANAGEMENT

1. HAZARD AND RISK MANAGEMENT
PRESENTED BY
SHREYASH P. CHAUDHARI
M.PHARM QUALITY ASSURANCE, 2ND SEM
SUBJECT
HAZARDS AND SAFETY MANAGEMENT
(MQA 201T)
DR. RAJENDRA GODE COLLEGE OF PHARMACY, MALKAPUR

2. C O N T E N T S
• INTRODUCTION
• PRINCIPLE
• SELF-PROTECTIVE MEASURES AGAINST WORKPLACE HAZARDS.
• CRITICAL TRAINING FOR RISK MANAGEMENT.
• PROCESS OF HAZARD MANAGEMENT.
• ICH GUIDELINES ON RISK ASSESSMENT AND RISK MANAGEMENT METHODS & TOOLS .
• FACTORY ACT AND RULES.
• FUNDAMENTALS OF ACCIDENT PREVENTION.
• ELEMENTS OF SAFETY PROGRAMME AND SAFETY MANAGEMENT.
• PHYSICOCHEMICAL MEASUREMENTS OF EFFLUENTS, BOD, COD.
• DETERMINATION OF SOME CONTAMINANTS, EFFLUENT TREATMENT PROCEDURE.
• ROLE OF EMERGENCY SERVICES.

3. INTRODUCTION
Risk management principles are effectively
utilized in many areas of business and government
including finance, insurance, occupational safety,
public health, pharmacovigilance, and by agencies
regulating these industries.

4. PRINCIPLE
PRINCIPLES OF QUALITY RISK MANAGEMENT
Two primary principles of quality risk management are:
• The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the
protection of the patient.
• The level of effort, formality and documentation of the quality risk management process should be
commensurate with the level of risk.

5. SELF-PROTECTIVE MEASURES AGAINST WORKPLACE HAZARDS
• Developing the program.
• Reporting hazards and developing solutions that improve safety and health.
• Analyzing hazards in each step of routine and non-routine jobs, tasks, and processes.
• Defining/documenting safe work practices.
• Conducting site inspections.
• Developing and revising safety procedures.
• Participating in incident and close call/near miss investigations.
• Serving as trainers for current coworkers and new hires.
• Developing, implementing, and evaluating training programs.

6. CRITICAL TRAINING FOR RISKMANAGEMENT
CRITICAL EMPLOYEE TRAINING
1. Develop comprehensive training courses.
2. Monitor participation in training.
3. Assess training effectiveness and continuously improve.

7. Process of Hazard Management
Steps for Hazard Management.
I. Hazard Identification.
II. Risk Assessment
III. Controls
1. Eliminate
2. Isolate
3. Minimize
IV. Monitor and Review

9. ICH GUIDELINES ON RISK ASSESSMENT AND RISK MANAGEMENT METHODS AND TOOL
QUALITY RISK MANAGEMENT Q9
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to
consultation by the regulatory parties, in accordance with the ICH Process.
RISK ASSESSMENT
Risk Assessment Risk assessment consists of the identification of hazards and the analysis and evaluation of
risks associated with exposure to those hazards (as defined below). Quality risk assessments begin with a well-defined
problem description or risk question.

11. FACTORY ACT AND RULES
Objective of Factories Act,1948
The main objectives of the Indian Factories Act, 1948 are to regulate the working conditions in factories, to
regulate health, safety welfare, and annual leave and enact special provision in respect of young persons, women and
children who work in the factories.
• Working hours
• Health
• Safety
• Welfare
• penalties

12. FUNDAMENTALS OF ACCIDENT PREVENTION
Definitio ns
Incident - an incident is an undesirable occurrence that could, but usually does not, result in a loss.
Accident - an accident is an unplanned, unforeseen and undesirable occurrence which interrupts a normal activity and
which result in either an injury, loss of life, damage to material, equipment or facility or any combination of these.
Preventable accident - an accident that occurred as a result of an act or failure to act on the part of an employee or
the management or both.
Unpreventable accident - an accident which no act whatsoever on the part of the employee could have prevented the
injury or damages to vehicle, equipment or property
Unsafe act - any act on the part of a person which increased his or her chances of having an accident.
Unsafe condition - A condition within the working environment which increases the worker's chances of having an
accident, or which may cause impairment of health.
Hazard - any arrangement, equipment, material, object, condition, method or procedure capable of causing bodily
harm or impairment of health or both.

13. ELEMENTS OF SAFETY MANAGEMENT SYSTEM
A safety management system combines all the different elements in your workplace that need attention to
ensure you provide a safe working environment for everyone who enters it.
Safety management systems make health and safety an integral part of your business's core operations. By
designing, developing and implementing an effective safety management system, you will have methods for
managing reporting, responsibilities, planning and resourcing to create a safer workplace.
Safety management systems have six elements:
• A safety plan
• Policies, procedures and processes.
• Training and induction.
• Monitoring.
• Supervision.
• Reporting.

14. PHYSICOCHEMICAL MEASUREMENT OF EFFLUENTS,BOD, DETERMINATION OF SOME
CONTAMINANTS
physicochemical parameters,
• pH
• Temperature
• Turbidity
• BOD
• COD
• Conductivity,
• Total alkalinity

15. BOD - Biochemical Oxygen Demand is a measure of the quantity of oxygen consumed by microorganisms during
the decomposition of organic matter. BOD bottle was prepared and incubated at 20° C for 5 days in the dark. After
five days, incubated BOD bottle was poured with mixing 2 ml of orthophosphoric acid. This was shaken gently and
titrated with sodium thiosulphate to the end point where there was change in color. The titre value represents dissolve
oxygen on day five. BOD was then calculated as the difference between dissolve oxygen on day one and that on day
five.
COD - Chemical Oxygen Demand is the oxygen requirement of a sample for oxidation of organic and inorganic
matter, determination of COD was done as per the method described in standard methods. 50 ml of the water sample
was taken in a reflux flask, and 10 ml of potassium dichromate solution with 1 g mercuric sulphate was thoroughly
mixed. Antibumping beads were added to control boiling of the solution. To this, 10 ml of concentrated sulphuric acid
containing silver sulphate was added through the open end of the condenser carefully and mixed by swirling motion.
The reflux apparatus was operated for around hour and allowed to cool. The flask was removed, and its content was
diluted to 150 ml with distilled water. To the resulting solution, three drops of the ferroin indicator were added. This
sample was titrated with standard ferrous ammonium sulphate to an end point where blue-green color just changed to
reddish-brown. Chemical oxygen demand (COD) of the blank sample was then calculated.

17. Role of emergency service
During an emergency situation, it is all too easy to become confused and disoriented. But with a little bit of
preparation, you can ensure that you can go through any emergencies in the best possible way. Recently '112' was
launched as a pan-India emergency helpline number. You can use this single emergency helpline number for various
emergency services such as police, fire and ambulance etc. It provides 24*7 emergency responses across the country.
An immediate assistance will be provided to the affected.
Four most important emergency numbers:
NATIONAL EMERGENCY NUMBER-112
POLICE - 100
FIRE-101
AMBULANCE-102