3. PRINCIPLES OF QUALITY RISK MANAGEMENT
• THERE ARE TWO PRINCIPLES OF QUALITY RISK
MANAGEMENT:
• THE THE EVALUATION OF RISK TO QUALITY SHOULD BE
BASED ON SCIENTIFIC KNOWLEDGE & ULTIMATELY LINK
TO THE PROTECTION OF PATIENTS.
• THE LEVEL OF EFFORT, FORMALITY & DOCUMENTATION
OF QUALITY RISK MANAGEMENT PROCESS SHOULD BE
COMMENSURATE WITH THE LEVEL OF RISK
4. SELF PROTECTIVE MEASURES AGAINST
WORKPLACE HAZARDS
1) REPORTING HAZARDS & DEVELOPING SOLUTIONS THAT IMPROVE SAFETY & HEALTH
2) ANALYSING HAZARDS ROUTINELY & NON- ROUTINELY
3) DEFINING SAFE WORK PRACTICES: RECORDS CAN HELPS HAZARDS & CONTROL RISKS
.
4) CONDUCTING SITE INSPECTION
5) DEVELOPING & REVISING SAFETY PROCEDURES
6) PARTICIPATING IN INCIDENT & NEAR MISS INVESTIGATION
7)SERVING AS TRAINER FOR NEW HIRES: DISCUSS OR TELL ABOUT SAFE
ENVIRONMENT,SÀFE ORK SYSTEM,SAFE RESOURCES & EQUIPMENT, INFORMATION
ABOUT HAZARDS.
5. • 8) EVALUATING TRAINING PROGRAM
PROCESS OF HAZARDS MANAGEMENT
HAZARD IS A SITUATION THAT POSSESS A LEVEL OF THREAT TO LIFE ,HEALTH, PROPERTY, ENVIRONMENT
• HAZARD MANAGEMENT
• IS A PROBLEM SOLVING PROCESS IDENTIFY HAZARDS , GATHERING INFORMATION,SOLVING THEM
• STEPS OF HAZARD MANAGEMENT
• IDENTIFICATION
• RISK ASSESSMENT
• CONTROL( ELIMINATION & SUBSTITUTION, ENGINEERING CONTROLS, PERSONAL PROTECTIVE EQUIPMENT)
• MONITOR & REVIEW
6. ICH GUIDELINES ON RISK ASSESSMENT &RISK
MANAGEMENT METHODS & TOOLS
• BASIC TERMINOLOGIY
• QUALITY : IS A DEGREE OF EXCELLENCE
• QUALITY RISK MANAGEMENT: SYSTEMATIC PROCESS FOR ASSESSMENT,
CONTROL, COMMUNICATION & REVIEW OF RISK
• QUALITY SYSTEM: ENSURE QUALITY OBJECTIVE ARE MET
• RISK ASSESSMENT: CONSIST OF IDENTIFICATION OF HAZARDS & ANALYSIS &
EVALUATION OF RISK
• RISK IDENTIFICATION: USE OF INFORMATION TO IDENTIFY HARM
7. • RISK ANALYSIS: ESTIMATION OF RISK ASSOCIATED WITH IDENTIFIED HAZARDS
• RISK EVALUATION: COMPARISON OF ESTIMATED RISK TO GIVEN RISK CRITERIA
• RISK CONTROL: ACTIONS TAKES TO REDUCE THE OCCURRENCE THE HARM
• RISK ACCEPTANCE: DECISION TO ACCEPT RISK
• RISK MANAGEMENT: SYSTEMATIC USE OF POLICIES, PROCEDURE,
PROCEDURE,PRACTICES TO ASSESS CONTROL COMMUNICATIING & REVIEWING
RISK
8. • RISK COMMUNICATION: SHARING OF INFORMATION ABOUT RISK
• RISK REVIEW : REVIEW OR MONITOR RESULTS OF RISK MANAGEMENT PROCESS
• REQUIREMENTS: EXPLICIT OR IMPLICIT NEEDS OF PATIENTS
• DECISION MARKER: AUTHORITY TO MAKE APPROPRIATE & TIMELY QUALITY RISK MANAGEMENT
DECISIONS
• PRODUCT LIFE CYCLE : ALL PHASES IN LIFE OF PRODUCT FROM INITIAL DEVELOPMENT
THROUGH MARKETING UNTIL THE PRODUCT’ S DISCONTINUATION
• TREND : RATE OF CHANGE OF VARIABLES
• STAKEHOLDER: ORGANISATION THAT AFFECT ,BE AFFECTED BY OR AFFECTED BY RISK
9. SCOPE
• DRUG SUBSTANCES
• DRUG MEDICINAL PRODUCTS
• BIOLOGICAL & BIOTECHNOLOGICAL PRODUCTS
• INCLUDING THE SELECTION & USE OF
RAW MATERIAL
SOLVENTS
EXCIPIENTS
PACKAGING & LABELLING MATERIALS
COMPONENTS
10. PRINCIPLES OF QUALITY RISK MANAGEMENT
• TWO PRIMARY PRINCIPLES ARE:
• EVALUATION OF RISK TO QUALITY SHOULD BE BASED ON SCIENTIFIC KNOWLEDGE
• THE LEVEL OF EFFORT, FORMALITY & DOCUMENTATION OF QUALITY RISK MANAGEMENT
• GENERAL QUALITY RISK MANAGEMENT PROCESS
• INITIATE QUALITY RISK MANAGEMENT PROCESS
• RISK ASSESSMENT: RISK IDENTIFICATION,RISK ANALYSIS, RISK EVALUATION
• RISK CONTROL: RISK REDUCTION, RISK ACCEPTANCE
• RESULT OF QUALITY RISK MANAGEMENT PROCESS
• RISK REVIEW: REVIEW EVENTS
11. RESPONSIBILITIES
• TAKE RESPONSIBILITY FOR COORDINATING QUALITY RISK MANAGEMENT
• ASSURES QUALITY RISK MANAGEMENT PROCESS IS DEFINED, REVIEWED
• INITIATING A QUALITY RISK MANAGEMENT PROCESS
• DEFINE PROBLEM,RISK QUESTION
• ASSEMBLE BACKGROUND INFORMATION
• IDENTIFY A LEADER & NECESSARY RESOURCES
• SPECIFY TIMELINE FOR RISK MANAGEMENT PROCESS
12. RISK COMMUNICATION
• IS SHARING OF INFORMATION ABOUT RISK & RISK MANAGEMENT
• PARTIEA CAN COMMUNICATE AT ANY STAGE OF RISK MANAGEMENT PROCESS
• INCLUDE AMONG INTERESTED PARTIES E.G INDUSTRY AND PATIENT , REGULATORS & ASSEMBLY
• OUTPUTS OF RISK MANAGEMENT CAN BE PROPERLY COMMUNICATED & DOCUMENTED
• RISK REVIEW
• TO CHECK ACCURACY
• TO REGISTER THE CHANGES
• TO MENTION THE NEW STEPS OR TECHNOLOGIES THAT CAN BE TAKEN INTO USE
• BASED UPON LEVEL OF RISK
13. RISK MANAGEMENT METHODOLOGY
• PROVIDE DOCUMENTED , TRANSPARENT & REPRODUCIBLE METHODS TO ACCOMPLISH THE
STEPS OF RISK MANAGEMENT PROCESS
• HANDLING OF COMPLAINTS, QUALITY DEFECTS ,
TOOLS:
BASIC RISK MANAGEMENT FACILITATION METHODS
FAILURE MODE, EFFECT & CRITICALLY ANALYSIS
FAILURE MODE ANALYSIS
FAULT TREE ANALYSIS
HAZARDS ANALYSIS & CRITICAL CONTROL POINTS
14. • RISK RANKING & FILTERING
• SUPPORTING STATISTICAL TOOLS
• INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY & REGULATORY OPERATIONS
• FACILITATE BETTER USE OF RESOURCES BY AL PARTIE
• TRAINING OF BOTH INDUSTRY & REGULATORY PERSONNEL
• PROVIDING FOR GREATER UNDERSTANDING OF DECISION MAKING PROCESSES
• MIGHT PROVIDE INFORMING PHARMACEUTICAL OPERATIONS
• QUALITY MANAGEMENT
• FACILITY, EQUIPMENT & UTILITIES
• LABORATORY CONTROL& STABILITY TESTING
15. • PRODUCTION
• MATERIALS MANAGEMENT
• FACTORY ACT & RULES
• INITIATION : STARTED WITH PLANNING, EMPLOYED WOMEN & CHILDREN IN FACTORIES WHO
NEEDED WORK FOR MORE THAN 12 HOURS A DAY
• FINAL AMENDED OF FACTORY ACT TOOK PLACE IN 1948
• FACTORIES ACT IN INDIA
• PASSED IN 1881
• DESIGN TO PROTECT CHILDREN & PROVIDE SAFETY TO HEALTH OF WORKERS
16. • FACTORIES ACT INCLUDE
• HEALTH
• SAFETY
• WELFARE
• WORKING HOURS OF ADULT
• ANNUAL LEAVE WAGES
17. DEFINITION
• FACTORY MEANS PREMISES INCLUDING 10 OR MORE THAN 10 WORKER WORKING ON
ANY DAY
• MANUFACTURING PROCESS PROCESS FOR MAKING ,ALTERING ,
FINISHING,PACKAGING,WASHING, CLEANING,BREAKING UP PUMPING OIL ,WATER FOR
TRANSFORMING POWER
• CONSTRUCTING , RECONSTRUCTING, REPAIRING, REFITTING
• DAY A PERIOD OF 24 HOURS
• WEEK: PERIODS OF 7 DAYS
• CALENDER YEAR PERIODS OF 12 MONTHS
• POWER ELECTRICIAL ENERGY OR OTHER ENERGY
18. • POWER MOVER MEANS ENGINE ,MOTOR WHICH PROVIDE ENERGY
• OBJECTIVES
• ENSURES ADEQUATEA SAFETY MEASURES
• PROMOTE HEALTH & SAFETY
• MAKES PROVISION REGARDING EMPLOYMENT OF WOMEN , ADULTS CHILDREN
,ANNUAL LEAVES
19. PROVISION REGARDING HEALTH
• CLEANLINESS
• DISPOSAL OF WASTE & EFFLUENTS
• VENTILATION & TEMPERATURE
• DUST & FUMES
• ARTIFICIAL HUMIDIFICATION
• OVERCROWDING
• LIGHTNING
• DRINKING WATER
• URINALS
• SPITOONS
20. PROVISION REGARDING SAFETY
• FENCING MACHINERY
• SELF ACTING MACHINES
• EXCESSIVE WEIGHTS
• PRECAUTIONS IN CASE OF FIRES
• SAFETY OF BUILDING & MACHINES
• SAFETY OFFICER
• PROTECTION OF EYES
• INFLAMABLE DUST ,GAS
21. PROVISION REGARDING WELFARE OF
WORKERS
• WASHING FACILITIES
• FACILITIES FOR STORING & DRYING CLOTHING
• FACILITIES FOR SITTING
• FIRST AID FACILITIES
• CANTEENS,SHELTERS, REST ROOMS, LUNCH ROOMS ,WELFARE OFFICERS
22. HAZARDOUS PROCESSES
• PROVISION REGARDING THIS PROCESS INSTRUCTED IN ACT UNDER NEW CHAPTER BY FACTORY
ACT 1987
• CONSTITUTION OF SITE APPRAISAL COMMITTEE
• COMPULSORY DISCLOSURE OF INFORMATION
• MAINTAINING ACCURATE & UP TO DATE HEALTH & MEDICAL RECORDS OF WORKERS EXPOSED
TO ANY CHEMICAL
• PROVIDING MEDICAL EXAMINATION OF EVERY WORKERS AT INTERVALS
• EMEEGWNCY STANDARDS
• APPOINTMENT OF INQUIRY COMMITTEE
23. WORKING HOURS OF ADULTS
• WEEKLY LESS THAN 48 HOURS
• AT LEAST ONE HOLIDAY IN WEEK
• COMPENSATORY HOLIDAY
• DAIKY WORK LESS THAN 9 HOURS
• HALF HOUR OF INTERVAL FOR REST
• NIGHT SHIFT
• NOTICE OF PERIOD OF WORKS
24. RESTRICTION ON EMPLOYMENT OF WOMEN &
CHILDREN
• WORK BETWEEN 6 AM TO 7 PM
• RESTRICTION FOR WOMEN EMPLOYEES BETWEEN 10 PM TO 5 AM
• SHIFT FOR WOMEN IN NIGHT ONLY WHEN FISH CANNING & FISH CURRING ARE
PERMITTED
• ANNUAL FEES WITH WAGES
• ANNUAL FEES FOR WAGES
• WAGES DURING LEAVE PERIODS
• PAYMENT IN ADVANCE IN CERTAIN CASES
• POWER TO MAKE RULES
25. OFFENCES & PENALTIES
• CONSIST OF WRITTEN ORDER MADE BY INSPECTOR,
• COMPLAINT MAY BE MADE WITHIN 6 MONTH OF COMMISSION OF OFFENCES
• GENREAL PENALTIES FOR OFFENCE
• PENALTY FOR OBSTRUCTING INSPECTOR
• PENALTY FOR WRONGLY DISCLOSING RESULTS OF ANALYSIS
• PENALITIES FOR OFFENCES BY WORKERS & PARENTS
• PENALTY FOR EMPLOYING CHILD LABOUR
• PENALTY FOR OFFENCE BY MEDICAL PRACTITIONER
26. FUNDAMENTALS OF ACCIDENT PREVENTION
• INCIDENT: UNDESIRABLE OCCURENCE BUT NO LOSS
• ACCIDENT UNPLANNED UNDESIRABLE OCCURENCE CAUSE HARM INJURY LOSS
• PREVENTABLE ACCIDENT OCCURED AS A RESULT OF ACT
• UNPREVENTABLE ACCIDENT PREVENT INJURY , DAMAGES, HARM
• UNSAFE ACT ACT ON THE PART OF PERSON WHICH INCREASES CHANCES OF
ACCIDENTS
• UNSAFE CONDITIONS INCREASE WORKERS CHANCES OF HAVING ACCIDENT WHICH
CAUSE IMPAIRMENT OF HEALTH
• HAZARD UNDESIRABLE CONDITION CAUSE HARM
27. BASIC ACTIVITIES
• STUDY OF ALL WORKING AREA TO DETECT & ELIMINATE PHYSICAL HAZARDS
• STUDY OF ALL OPERATING METHODS & PRACTICES
• EDUCATION, INSTRUCTIONS, TRAINING,TO MINIMISE HUMAN FACTORS
• INVESTIGATION OF ACCIDENTS TO DETERMINE CONTRIBUTING CIRCUMSTANCES
28. PREVENTABLE ACCIDENTS
NOONE CAN PREVENT ACCIDENT BUT SOME SAFETY MEASURES SHOULD BE TAKEN
ACCIDENT PREVENTION TECHNIQUE
TYPICAL UNSAFE ACT
FAILURE TO FOLLOW INSTRUCTIONS OR PROPER JOB PROCEDURE
CLEANING OILING , ADJUSTING OR REPAIRING EQUIPMENTS
FAILURE TO WEAR SAFE PERSONAL ATTIRE
FAILURE TO SECURE OR WARN
IMPROPER USE OF HANDS OR BODY PARTS
30. UNSAFE CONDITIONS
• CLASSIFICATION:
• DEFECTIVE, INFERIOR UNSUITABLE TOOLS ,MACHINERY,EQUIPYOR MATERIALS
• HAZARDS OF SURROUNDING
• HAZARDOUSBMWTHODA OR PROCEDURES
• INADEQUATE GUARDING OF MACHINERY , EQUIPMENT,WORK AREAS ATC
• CONTROL OF ACCIDENT CAUSE
• METHODS : ENGINEERING ( EQUIPMENT, MACHINERY & THEIR PARTS ARE PROPERLY
WORKS OR NOT
31. • EDUCATION & TRAINING
• ENFORCEMENT: STRICTLY ENFORCEMENT OF SAFETY MEASURES, PRACTICES
• ENTHUSIASM: CAN BE EFFECTIVE TO GOOD DEGREE IN PREVENTION OF
ACCIDENTS
• ELIMINATION OF UNSAFE CONDITIONS
• REPAIR DAMAGE FLOOR , BROKEN GLASSES, CRACKED WALLS & CEILING
• REPLACE DAMAGED TOOLS
• PROVIDE PROTECTIVE EQUIPMENT (GOOGLE, GLOVES)
32. CONTROL OF WORK HABBIT
• TEACHING EMPLOYEES
• INSTRUCTIONS & GUIDANCE
• SAFE PRACTICES & GUIDELINES
• SAFETY ORIENTATION OF NEW EMPLOYEES
• TRAINING TO NEW EMPLOYEES ( MUST BE PUNCTUAL,LOYAL ,& SINCERE)
• HAVING GOOD SAFETY ATTITUDE
• IF THE PERSON IS EXPERIENCED THAN ALL PROVIDE THEM INSTRUCTIONS & TRAINING FOR
WORK & CHECK THEIR WORKING SKILLS
• SAFETY RULES & PROCEDURE REVIEWED & TAKEN IN USE
