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AmitMasand5

This document discusses principles of quality risk management and hazard management. It covers two key principles of quality risk management: risk evaluation should be based on scientific knowledge and the level of effort in risk management should be proportional to the level of risk. It also discusses hazard identification, risk assessment, control methods, and monitoring and review in hazard management. The document provides an overview of the Factories Act in India relating to factory definitions, provisions for health, safety, welfare, working hours and penalties.

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INSTITUTE OF PHARMACEUTICAL SCIENCES KURUKSHETRA UNIVERSITY KURUKSHETRA SUBMITTED TO : ANJU MAM SUBMITTED BY : JYOTI (PROFESSOR) M.PHARMA (QA)2 SEM
1. HAZARDS AND RISK MANAGEMENT
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
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.
• 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
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
• 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
• 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
SCOPE • DRUG SUBSTANCES • DRUG MEDICINAL PRODUCTS • BIOLOGICAL & BIOTECHNOLOGICAL PRODUCTS • INCLUDING THE SELECTION & USE OF RAW MATERIAL SOLVENTS EXCIPIENTS PACKAGING & LABELLING MATERIALS COMPONENTS
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
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
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
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
• 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
• 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
• FACTORIES ACT INCLUDE • HEALTH • SAFETY • WELFARE • WORKING HOURS OF ADULT • ANNUAL LEAVE WAGES
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
• 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
PROVISION REGARDING HEALTH • CLEANLINESS • DISPOSAL OF WASTE & EFFLUENTS • VENTILATION & TEMPERATURE • DUST & FUMES • ARTIFICIAL HUMIDIFICATION • OVERCROWDING • LIGHTNING • DRINKING WATER • URINALS • SPITOONS
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
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
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
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
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
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
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
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
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
• UNSAFE PLACING, MIXING, COMBINING • CLOWNING • HORSEPLAY • REASON FOR UNSAFE ACT • LACK OF KNOWLEDGE,SKILL, PLANNING • IMPROPER ATTITUDE • CARELESSNESS
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
• 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)
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
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Presentation (11)-1.pptx

  • 1. INSTITUTE OF PHARMACEUTICAL SCIENCES KURUKSHETRA UNIVERSITY KURUKSHETRA SUBMITTED TO : ANJU MAM SUBMITTED BY : JYOTI (PROFESSOR) M.PHARMA (QA)2 SEM
  • 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
  • 29. • UNSAFE PLACING, MIXING, COMBINING • CLOWNING • HORSEPLAY • REASON FOR UNSAFE ACT • LACK OF KNOWLEDGE,SKILL, PLANNING • IMPROPER ATTITUDE • CARELESSNESS
  • 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