Occupational Safety and Health Standards

LESSON 1: OCCUPATIONAL SAFETY AND RULE 1000: GENERAL PROVISION HEALTH STANDARDS Purpose: to protect every working man against the dangers of injury, sickness, or...

LESSON 1: OCCUPATIONAL SAFETY AND RULE 1000: GENERAL PROVISION HEALTH STANDARDS Purpose: to protect every working man against the dangers of injury, sickness, or death through safe and healthful working conditions Why the need for OSH? Scope: shall apply to all places of employment Reduces injury and illnesses except land sea and air transportation and safety in Improves work quality and employee mines. productivity Helps you retain your employees. RULE 1010: OTHER SAFETY RULES Saves money when you comply with Promulgation of rules regulations. Special rules Common Types of Injury Hazardous Workplaces Open wounds RULE 1020: REGISTRATION Superficial injuries Burns and corrosions RULE 1030: TRAINING OF PERSONNEL IN Top Agents of Injury OCCUPATIONAL SAFETY AND HEALTH Machines and equipment TRAINING PROGRAMS Hand tools Training programs Materials and objects Accreditation Parts of the Body mostly Injured Training and Personnel Complement a. Hazardous Workplace Head 200 and below – 1 part-time safety man Wrist and Hand Over 200 – 1000 – 1 full-time safety man Lower extremities For every 1000 – 1 full-time safety man b. Non-Hazardous Workplace Leading Causes of Injury Qualifications of a Safety Consultant Caught by or in between objects RULE 1040: HEALTH AND SAFETY COMMITTEE Stepping on, striking against, or struck by objects, excluding falling objects Types of composition of health and safety Falls of person committee 1. Type A Most Injured Occupations - In every workplace having a total of over Plant and machine operators and 400 workers the following shall compose assemblers the Health and Safety Committee: Elementary occupations Chairman, Members (2 Dep. Heads, 4 Service and sales workers workers, company physician), safety man 2. Top 3 Industries 2. Type B - total of over 200 to 400 workers: Manufacturing chairman, members (1 supervisor, 3 Administrative and support service activities workers, company physician or company Human Health and Social Work Activities nurse), safety man. Except Public Health Services 3. Type C - 100 to 200 workers: chairman, members (1 foreman, 3 workers, nurse), secretary (a part-time safety man)  4. Type D Hot and corrosive substances - less than 100 workers: chairman, Storage Use of lead and its compound members (1 foreman, 3 workers, nurse/first-aider), secretary (a part-time safety man) GAS AND ELECTRIC WELDING AND CUTTING 5. Type E: Joint Committee OPERATIONS - When two or more establishments are housed under one building, the health - closely regulated to prevent hazards and safety committee organized in each associated with high-temperature workplace shall form themselves into a processes. Joint Coordinating Committee to plan - These operations involve the use of and implement programs and activities flammable gasses and electrical concerning all the establishments. This equipment to join or cut metals includes the chairman, members (2 HAZARDOUS WORK PROCESSES supervisors from two different. establishments, 2 workers from two - Operations that pose significant risks to different. establishments, and secretary workers' health and safety. These (appointed by the chairman). processes include activities that involve Duties dangerous chemicals, heavy machinery, and extreme temperatures, A more RULE 1050: NOTIFICATION AND KEEPING OF specific example of such work is RECORDS OF ACCIDENTS AND/OR an underground tank and similar OCCUPATIONAL ILLNESSES confined space work Special provision EXPLOSIVES Report requirements Keeping records - The handling and use of explosives are Evaluation of Disability strictly regulated due to their high-risk Measurement of Performance nature. a. Exposure to industrial injuries - Standards include safe storage and b. Determination of employee hours of handling, proper training for workers, and exposure clear procedures for emergencies. c. Measure of injury/illnesses experience MATERIAL HANDLING AND STORAGE RULE 1060: PREMISES OF ESTABLISHMENTS - Storing materials to prevent accidents and injuries. - This includes ensuring safe use of RULE 1070: OCCUPATIONAL HEALTH AND equipment, keeping storage areas free ENVIRONMENTAL CONTROL from hazards, and keeping materials organized. Threshold limit values for airborne contaminants BOILERS RULE 1080: PERSONAL PROTECTIVE - closed vessels that generate steam or EQUIPMENT AND DEVICES hot water for various industrial and heating applications. Eye and Face protection - They pose several hazards, including Respiratory Head high-pressure steam, extreme Hand and Arm temperatures, and potential explosions if Safety belts, lifelines, and safety nets not properly maintained Safety shoes RULE 1090: HAZARDOUS MATERIALS General rules UNFIRED PRESSURE BOILERS POWER PIPING LINES - containers used to store or process - “Power Piping Line” shall include all gases or liquids under pressure without steam, water, air, gas, hazardous using an external heat source. substances, oil piping and the - These vessels must adhere to strict component parts such as the pipe, safety standards to prevent accidents. flanges, bolting, gaskets, valves, fittings - This involves regular inspections, proper and other components related to steam design, and maintenance to ensure they generating plants, central heating plants are secure and industrial plants. MACHINE GUARDING CONSTRUCTION AND SAFETY - Implementation of safety measures to - Construction and safety involve protect workers from accidents due to implementing measures and protocols to moving parts and hazardous machinery. protect workers and the public during - includes installing physical barriers or construction activities. enclosures around dangerous - It focuses on preventing accidents and components, using safety devices and injuries by ensuring safe work practices, sensors, and ensuring that guards are in proper use of equipment, and effective place at points of operation and in risk hazard management. areas. - Key aspects include worker training, safety inspections, and adherence to ELECTRICAL SAFETY safety standards to create a safe and - pose significant hazards if not properly secure construction environment. managed. LOGGING - Key risks include electrical shocks, burns, and fires. - “The logging industry, integral to both - Ensuring electrical safety involves economic development and regular inspections, proper maintenance, environmental stewardship, necessitates and adherence to safety protocols. stringent safety measures to protect workers and ensure sustainable ELEVATORS AND RELATED EQUIPMENT practices. - These are essential for moving people, - This section outlines the general materials, and products.\ provisions, tools, and operational - These include elevators, escalators, and guidelines critical to maintaining safety hoists. and efficiency in logging operations. - The common risk they have is FIRE PROTECTION AND CONTROL mechanical failures which can lead to falling of the lifted object or people. at least 2 exit doors - Ensuring safety involves regular The workplace must have portable maintenance, adherence to guidelines, extinguishers. and training employees on proper usage All buildings with 2 stories in height should be equipped with a fire alarm system. IDENTIFICATION OF PIPING SYSTEM Fire-exits drill shall be conducted at least - Piping systems transport fluids, gases, twice a year. and other materials throughout a plant. - Pipe identification includes labeling pipes PESTICIDES AND FERTILIZERS indicating their contents, flow direction, - In the context of agricultural and and pressure ratings. industrial operations, the management - Standards typically require consistent and use of pesticides and fertilizers are use of color codes, symbols, and signage critical for ensuring both productivity and environmental safety.  - Adhering to established guidelines and LESSON 2: INDUSTRIAL AND SAFETY AND standards is essential to prevent health SECURITY hazards and environmental damage. - The following summary provides an overview of the regulatory requirements WHAT IS INDUSTRIAL SAFETY AND SECURITY? and best practices for the application and handling of pesticides and fertilizers, Industrial Safety Prevents Hazards, Injuries, focusing on safety measures, legal And Illnesses For "Zero-Risk." obligations, and the qualifications Prevention Strategies Work at Enterprise, required for professionals involved in National, Regional, And International Levels. these processes. Challenges Arise Due to Inherent Industrial Hazards. OCCUPATIONAL HEALTH SERVICES Comprehensive Risk Understanding Informs - In the pursuit of maintaining a safe and Authorities and Guides Risk-Reduction healthy work environment, the Measures. Occupational Health Services standards Utilization Of Best Practices and Available provide comprehensive guidelines for Technologies for Effective Risk Reduction Is employers, medical practitioners, and Crucial. health personnel. IMPORTANCE - These regulations outline essential requirements for emergency medical Global Work-Related Facilities (ILO) services, practitioner qualifications, and the establishment of effective health Daily Toll: 6,500+ Work-Related Illness programs. Deaths, 1,000+ Occupational Accident - The following summary details the key Deaths. aspects of these standards, including the Annual Deaths Increased From 2.33m responsibilities of employers, the (2014) To 2.78m (2017). qualifications of health professionals, and Occupational Disease-Linked Deaths: 2.4m the procedures for health examinations Out of Total Deaths. and emergency care. Regional Distribution (2017): Asia (71.5%), Africa (18.9%), America (6.5%), Europe (2.9%). Highest Fatality Rates Per 100,000: Africa (17.4), Asia (13.0). Industrial Hazard Impact: Elevated risk levels compared to general workplaces. Potential for severe injuries, property damage, and environmental destruction. Associated with specialized tasks by trained employees Challenges of Injuries in Skilled Workers: Injuries disrupt production, shipping, vendor interactions, and customer satisfaction. Replacement challenges for skilled workers. Effective safety practices maintain operational continuity and satisfaction. RISK ASSESSMENT AND HAZARD measures. It follows a hierarchy that is IDENTIFICATION comprised of five sections. Risk Assessment and hazard identification are the REGULATORY FRAMEWORK IN THE first line of defense to prevent industrial incidents PHILIPPINES Hazard is anything that has the potential to Department of Labor and Employment cause harm. It could be an object, activity, or (DOLE) process. - Occupational safety and health Risk is the likelihood that somebody could be standards - protect workers from injury, harmed by the hazard. Risk is probability * sickness, or death by ensuring safe and severity. healthy working conditions. This Hazard creates risk i.e. solvents -> conserves manpower, prevents loss of inhalation, contact, accidental ingestion life and property, and supports national development goals. HOW TO USE A RISK MATRIX: Bureau of Fire Protection Identify project risks – determine what risks Fire Code of The Philippines (RA 9514) may affect the specific project you’re working on. - Legislation that outlines the country's fire Determine the severity of risks – define the safety standards. It serves as a criteria for your risk severity and likelihood. framework that guides the Bureau of Fire Identify the likelihood of risks Protection (BFP) in its crucial role of Calculate risk impact – likelihood x severity = enforcement and implementation, risk impact particularly in its fire safety inspections Prioritize risks and take action - determine and assigning the proper type of fire which risks are of top priority protection system applicable to a certain facility. ENGINEERING CONTROLS AND Department of Environment and Natural SAFEGUARDING MEASURES Resources Engineering controls Toxic Substances and Hazardous and Nuclear Wastes Control Act Of 1990 (RA 6969) - type of control that is implemented at the source of the hazard. - hazardous substances safety guidelines - These are tangible changes applied to a workplace, equipment, or process. ISO STANDARD IN INDUSTRIAL SAFETY The Principles of Engineering Controls: ISO (International Organization for Standardization) standards If feasible, design the facility, equipment, or process to remove the hazard and/or - internationally recognized guidelines, substitute something that is not hazardous or specifications, criteria, or frameworks is less hazardous. developed by the ISO, an independent, If removal is not feasible, enclose the hazard non-governmental organization. to prevent exposure in normal operations. - These standards are designed to ensure the quality, safety, efficiency, and Where complete enclosure is not feasible, interoperability of products, services, and establish barriers or local ventilation to systems across various industries reduce exposure to the hazard in normal worldwide. operations. ISO 45001: OCCUPATIONAL HEALTH Whenever a hazard is recognized, the top AND SAFETY MANAGEMENT SYSTEMS priority is to reduce, if not remove, the risk - international standard for managing assessed. workplace safety. Aims to prevent work- Risk control action is important in both related injuries, and illnesses, and improve hazard mitigation and safeguarding safety.  ISO 31000: RISK MANAGEMENT Implementation of Comprehensive OSH - Provides a framework for managing risks Programs Availability of Qualified effectively across all industries. Aims to Occupational Health Personnel identify, assess, and mitigate risks to Enforcement of Accountability Dynamic improve decision-making and outcomes. and Inclusive OSH Policies ISO 22301: BUSINESS CONTINUITY INDUSTRY-SPECIFIC STANDARDS IN THE PH MANAGEMENT - International standard for planning and - various safety standards based on the managing business continuity. Ensures hazards, risks, and environments specific organizations can continue operations to each industry during disruptions. SAMPLE INDUSTRY-SPECIFIC STANDARDS NATIONAL AND LOCAL REGULATIONS Construction DOLE Occupational Safety and Health Standards (OSHS) and RA 11058: Act Strengthening CSHP – CONSTRUCTION SAFETY Compliance with Occupational Safety and Health AND HEALTH PROGRAM Standards and Providing Penalties for Violations DEPARTMENT ORDER NO. 13, Thereof” SERIES OF 1998 NATIONAL BUILDING CODE OF THE BACKGROUND OF RA 11058 PHILIPPINES – RA NO. 6541 LABOR CODE OF 1974 Maritime ESTABLISHMENT OF OSHS IN 1978 CONTINUOUS UPDATING OF THE PMMRR – PHILIPPINE MERCHANT OSHS MARINE RULES AND REGULATIONS ESTABLISHMENT OF RA 11058 IN 2018 MLC – MARITIME LABOR CONVENTION 2006 OUTLINE OF RA 11058 Food and Beverage Duties And Rights of Employers, Workers and Other Persons FOOD AND SAFETY ACT OF 2003 Covered Workplaces DOLE GUIDELINES FOR THE FOOD Employers’ Responsibility and Liability AND BEVERAGE INDUSTRY Enforcements Of Occupational Safety ENGINEERING PROCESS SAFETY and Health Standards INTEGRATION BENEFITS OF RA 11058 Safety in the Design and Development Phase Improved Workplace and Safety Health SAFETY IN A DESIGN Reduction In Workplace Accidents and Illnesses - a proactive approach to integrating safety Enhanced Productivity and Employee considerations into the design process. Morale Economic Benefits for PROACTIVE RISK MANAGEMENT: Businesses and the Economy - Hazard identification - designers and MAIN GOALS AND OBJECTIVES OF RA 11058 engineers must anticipate potential Ensure Safe and Healthful Workplaces safety issues and hazards that could Full Protection Against Workplace arise during the product's life cycle Hazards - Risk elimination or minimization - where possible, risks are eliminated Prevention of Workplace Accidents and through design choices. Illnesses Promote Worker’s Rights INHERENT SAFETY: BEST PRACTICES: SAFETY CULTURE AND TRAINING - This concept involves designing products in such a way that they inherently possess lower risks. DEVELOPING A SAFETY CULTURE COMPLIANCE AND STANDARDS: A. Assess Risks and Response Plans: - Safety by design often involves adhering evaluate risks, use tools like threat to specific safety standards and assessments, and prioritize actions based on regulations relevant to the industry impact and risk levels. B. Define Safety Objectives: OPERATIONAL SAFETY set clear safety goals, prioritize actions, and A. Safety Instrumented System promote accountability for a robust safety culture. - are specialized control systems designed C. Involve and Engage Everyone: to maintain or bring a process to a safe engage leaders and employees actively to state shift and sustain a strong safety culture. FUNCTION D. Develop Emergency Plans and Roles: create pre-emptive response plans, assign - SIS are automated systems that perform roles, and enable swift crisis decision- specific safety functions to prevent or making. mitigate hazardous events. E. Implement Safety Training: Go beyond lectures; involve employees in COMPONENTS OF SIS practical training for effective safety - Sensors, Actuator, And Logic Solver outcomes F. Exchange Feedback and Monitor: REGULATORY COMPLIANCE Use positive feedback, align with OSHA, to - Compliance with standards like IEC bridge safety culture gaps effectively. 61511 (Functional Safety - safety G. Strive for Continuous Improvement: instrumented systems for the process adapt, learn from incidents, assess risks, and industry sector) is often required. refine goals for ongoing safety enhancement. B. PROCESS HAZARD ANALYSIS (PHA) TRAINING PROGRAM FOR EMPLOYEE Purpose Based On DOLE OSH Standard 2017 - To identify potential hazards, assess the Rule 1030 risks associated with these hazards, and Bureau Organizes Initiates to Enhance develop strategies to mitigate or Qualified Individuals for Implementing eliminate these risks Standards. PHA techniques Bureau Defines Training Programs with Input Form Entities Like Up Institute of - Initiation, hazard identification risk Public Health, Who, Technical Societies. assessment, risk mitigation, and Programs Include Latest Advancements, documentation and review Methods, Technology for Occupational Safety Benefits - Prevent accidents by identifying and mitigating risks before they materialize. It TYPES OF TRAININGS also improves operational efficiency by INTERNAL TRAINING: highlighting areas where processes can Current employees guide new hires in be made safer and more reliable. skills-building and professional development.  OUTSOURCED TRAINING: MANDATORY TRAINING FOR SAFETYMAN professional hired to train employees on POSITION specific skills. Completion of a specific training course ON-THE-JOB TRAINING: mandated by the bureau is necessary. Practical, supervisor-guided training This training is a requirement for during work. individuals to be eligible for the OFF-THE-JOB TRAINING: safetyman position in a workplace Classroom, audio-visual. Reading, a. Hazardous Workplace correspondence courses, etc. Number of Workers No. of Safety Man TYPES OF TRAININGS IN INDUSTRIAL SAFETY 200 – below 1 part-time safety man MANAGEMENT Over 200 – 1000 1 full-time safety man GENERAL TRAINING For every 1000 workers 1 full-time safety man Orientation/ Introduction: Familiarize New Employee with Safety b. Non-hazardous Workplace Policies, Procedures. Number of Workers No. of Safety Man Management: Less than 1000 1 part-time safety man Develop Effective Team Management For every 1000 1 full-time safety man Skills Supervisor: Equip Supervisor with Necessary Skills CONCLUSION Technical Skills: EMPLOYEE’S SAFETY Apply Technical Knowledge to Job Roles On-Going Safety: - Industrial safety standard established Annual Refresher on Safety Policies guidelines to prevent accidents, injuries, Safety Representative: and fatalities among workers. Empower Safety Representatives for - Compliance with these standards creates Consolation a safer working environment, reducing the risk of harm to employee. SPECIFIC TRAINING LEGAL COMPLIANCE Safety System of Work for High Hazard Operations. - Adhering to industrial safety standards First Aid Training. ensures compliance with local, national Plant/ Equipment Use. Protective and international regulation. Equipment Safety Inspection. - This protects organization from legal Emergency Planning. penalties and liabilities due to workplace accidents or negligence. Techniques of Safety Audit ENVIRONMENTAL PROTECTION INCORPORATING RULES 1032 AND 1033 OF DOLE OSH STANDARD 2017 - Safety measures often include guidelines for minimizing environmental impact. BUREAU AUDITS AND COMPLIANCE - Preventing accidents and following Bureau conducts regular audits for proper protocol prevents pollution, waste, compliance with specific criteria, such as and ecosystem damage. training methods, staff quality, system effectiveness. Accreditation can be revoked by the secretary if rules are not followed upon director's suggestion.  LESSON 3: SAFETY AUDIT AND Identification of Exposures INVESTIGATION - Knowledge; label; compliance Safeguarding Exposures SAFETY AUDIT & ADMINISTRATIVE CONCEPTS - Evidence; PPE; safety devices Protection and Guarding Safety Audit - Guarded; marked; compliance - A structured, methodical assessment and Safety Organization evaluation of how workplace activities affect safety and health. - coordinator; time; commitments system - GOAL: Eliminate unsafe practices and hazards that lead to injuries and Environmental Controls accidents. - guidelines; signs; wastes Steps to do a Safety Audit Protecting Your Audits 1. Gather data about the program Audits are typically internal documents 2. Evaluate the data but may be reviewed by government Questions to ask when doing an audit: agencies. Public access to audit information is Did it follow environmental, safety, and limited, but agencies like OSHA can use health regulations? voluntary audit results during Did it comply with environmental, safety, inspections. and health regulations? The DOJ and EPA generally avoid Did it meet institutional standards? reviewing audits unless necessary, while OSHA may use audit findings to assess Three Main Actions of an On-Site compliance and potential willful 1. Audit Arrange interviews with key personnel. violations. 2. Review documentation, may include: SAFETY INSPECTION Emergency preparedness Hazard identification Systematic Inspection Control and monitoring - Identify and correct unsafe equipment, Safety education and training conditions, processes, and work 3. Conduct field assessment. practices Safety Audit Data Primary Goal: Where do we get our safety audit data? - Ensure conditions are satisfactory, not - Administrative Area: Management’s just to find faults program implementation Secondary Purpose: - Operational Area: Surroundings and external conditions - Correct conditions to meet accepted standards and regulations Physical Concepts and Protecting Your Audits Key Inspectors: - First-line supervisors, individual PHYSICAL CONCEPTS employees, maintenance employees, as Compliance well as inspection teams Law; responsible; priorities; safety program Inspection Teams Collaboration with Chemist Inspectors should be trained in handling hazardous Role: Help identify unsafe conditions that may be materials (dusts, gases, vapors, liquids) hard to notice Consult Chemists Key Member: Safety professional coordinates the MSDS Availability inspection and provides on-the-spot teaching Specialized Inspections Know safety rules, OSHA standards, Engineering Expertise laws, and regulations. Exceed minimum requirements for Health Surveys organizational safety policy Target Health Hazards Additional Members: Fire protection representative, Assessment Methods: Use air sampling Industrial hygienist, and volunteers eager to learn. and material testing for toxic fumes, gases, and dust Be selective Know what to look for Overhead Inspections Practice observing Common Hazards: Loose objects from Keep an open mind building structures, cranes, roofs, and Do not be satisfied with first impressions other overhead areas. Guard against habit and familiarity Record observations systematically Making the Report Use a checklist Emergency Report: made without delay 1. Contact the department head and solicit his whenever immediate corrective action is or her help. 2. Observe all conditions for compliance with necessary established standards (use checklist). Routine Report: unsatisfactory 3. Observe all operations for any unsafe acts or (nonemergency) conditions that require violations of safety rules. correction of name of the department or area Inspection: Obligations and Procedures inspected (boundaries or location, if needed) Inspection Team Obligations date and time of the inspection Wear Protective Gear date of the report Lead by Example: Practice what they names of individuals to whom the report preach was given Non-Interference unless there’s an Safety Checklist and Laws and Regulations in immediate threat the Philippines Inspection Procedures Safety Checklist Comprehensive Focus: Address - a structured document used to accident, fire, and environmental health systematically assess, monitor, and risks ensure safety compliance in workplaces, Minimal Paperwork processes, or equipment. Use checklists, but don’t rely solely on - It helps identify potential hazards, ensure them that safety protocols are followed, and Chemically Related Inspections verify that the environment and operations meet regulatory and Improper handling can cause fires or organizational safety standards. accidents. Safety Audit Checklist 5. Personal Protective Equipment - PPE refers to the clothing and equipment 1. General Workplace Safety worn by workers to protect themselves - refers to the overall practices, from workplace hazards. procedures, and conditions implemented (1) Availability and use of appropriate in any workplace to prevent accidents PPE for each task and injuries. (2) inspection and maintenance of PPE (1) Regular inspection of fire exits and (3) Employee training on proper PPE emergency plans. usage (2) Proper labeling and storage of 6. Electrical Safety chemicals (MSDS availability) - This covers the safe installation, (3) Adequate lighting and ventilation maintenance, and operation of electrical (4) Machine safety (guards, systems to prevent electrical hazards lockout/tagout procedures) such as shocks, burns, or fires. 2. Fire Safety (1) Inspections of wiring, circuit breakers, - This involves the prevention, control, and and electrical equipment response to fires in the workplace. Fire (2) Lockout/tagout procedures for energy safety protocols are designed to reduce control the likelihood of fire hazards and ensure (3) Grounding and bonding of electrical that there are systems in place to handle installations a fire emergency. (4) Protection from arc flashes and (1) Functioning fire alarms, electrical fires extinguishers, and sprinkler systems 7. Incident Investigation (2) Regular fire drills and staff training - This is the process of identifying the root (3) Clear and accessible evacuation cause of workplace accidents, injuries, or routes near misses to prevent their recurrence. (4) Fire hazard identification and control (1) Procedures for reporting accidents, 3. Chemical Safety injuries, and near misses - This pertains to the safe handling, (2) Investigation protocols for identifying storage, use, and disposal of hazardous root causes chemicals in the workplace. (3) Corrective action tracking and follow- (1) Availability of Material Safety Data up Sheets (MSDS) (2) Proper storage, handling, and Laws and Regulations in the Philippines disposal of hazardous chemicals Occupational Safety and Health Standards (3) Ventilation systems for chemical (OSHS) exposure (4) Spill containment and emergency - Enforces workplace safety standards, procedures requiring companies to follow proper 4. Construction Safety safety audit protocols, provide PPE, and - Construction safety refers to the specific create a safe working environment. safety practices and standards applied to construction sites to protect workers from Republic Act No. 11058 - An Act Strengthening the hazards associated with construction Compliance with Occupational Safety and Health activities. Standards and Providing Penalties for Violations (1) Fall protection systems (harnesses, - This law mandates strict implementation guardrails) of safety standards, including routine (2) Excavation safety (barriers, safety audits, hazard reporting, and inspections, trench boxes) worker participation in safety programs. (3) Machinery and heavy equipment inspections Republic Act No. 9514 - Fire Code of the (4) Scaffolding safety (proper erection, Philippines inspection, use) Republic Act No. 6969 - Toxic Substances and LESSON 4: THE IMPORTANCE OF CGMP IN A Hazardous and Nuclear Wastes Control Act of WORKPLACE 1990 Department of Environment and Natural Current Good Manufacturing Practice Resources (DENR) Administrative Orders – - ensure continuous improvement in the - Clean Air Act (RA 8749) and Clean approach of manufacturers to product Water Act (RA 9275) also mandate quality industries to implement safety measures - implies a constant commitment to the to prevent environmental hazards. highest available quality standards - DENR AO No. 36, s. 2004 - Revises through the use of up-to-date systems rules on hazardous waste management and technologies and requires safe waste disposal methods. Good Manufacturing Practice Philippine Electrical Code (PEC) - basic regulation implemented by Food and Drug Administration (FDA) under Building Code of the Philippines (RA 6541) the authority of the Federal Food, Drug, Department of Energy (DOE) Guidelines and Cosmetic Act - ensure that the manufactured products DOH Administrative Orders are consistently produced and - For industries like healthcare, safety controlled according to set quality audits must also include compliance with standards DOH guidelines on infection control, cGMP GMP workplace safety, and hazard COST More expensive Cost-friendly to management. as it involves implement as it acquiring new only involves the technologies basic guidelines that companies would adhere USAGE Applied to less More than 100 countries countries have compared to set manufacturing GMP regulations based on GMP QA More reliable in Lower quality quality assurance rate assurance due due to lack of to the additional automation and use of innovative use of technology technology in the processes, and system employed AREAS THAT INFLUENCE SAFETY AND QUALITY GMP Guidelines Address the following: Quality Management Sanitation and Hygiene Building and Facilities Raw materials  Validation and Qualifications THE CGMP GUIDELINES Equipment Not legally binding Documentation and Recordkeeping Compliance Nature: Private Organizations or Industry groups Inspection Quality Audits Recognitions: Generally voluntary, unless adopted Personnel by a regulatory body FIVE (5) MAIN COMPONENTS OF CGMP Impact: Company reputation, batch recalls, PEOPLE consumer feedback Comprehend roles and responsibilities. PROCESSES Properly documented, simple, and MEETING CGMP GUIDELINES consistent. Improves overall performance of different systems PREMISES Cleanliness and calibration of equipment Compliance with legislative orders at all times. Increase Product Quality PRODUCT Customer Satisfaction Clear specification at every phase of Increase Sales and Profit production PROCEDURES FRAMEWORK AND ORGANIZATIONS Guidelines for undertaking critical ISO 9001, ISO 14001, ISO 45001, ISO 13485 procedures INDUSTRY SPECIFIC STANDARDS TEN PRINCIPLES OF CGMP API 650, API 620, 1. CREATE – SOP and design specification 2. FOLLOW – SOP and specification effectively ICH Q1A(R2), ICH E6(R2) 3. VALIDATE – SOP specification effectiveness 4. MONITOR – all facilities and equipment UPHOLDING THE CGMP STANDARDS 5. DOCUMENT – all facilities and equipment 6. EMPLOY – competent and qualified Quality Teams personnel Component: 7. PROTECT – products from contamination Skilled Workers 8. CONTROL – components and process Impact: 9. ENSURE - overall quality of facilities, Continuous improvement and process, and equipment compliance 10. PERFORM – GMP audits regularly Responsibilities: CGMP Regulations Performing Quality Assessments and Schedule Monitoring 1. Manufacturers’ respective 01 national government. Validation 2. Guidelines to ensure that products are 02 Components: safe, effective, and high-quality. Instruments, Processes 3. Example is the FDA’s Code of Federal 03 Activities: Regulations Functionality Testing, Demonstration Impact: Evaluate consistency with predetermined specifications Surprise Audits  Component: Unannounced audits Results: Identification of areas for improvement and root causes of noncompliance Impact: Real-time compliance assessment Compliance Training Components Recordkeeping, Sanitation, Proper Equipment Handling, Labeling, SOPs Results Better understanding of cGMP and of their roles Impact Minimize errors and maintain compliance