The document discusses the key elements of an Occupational Health and Safety Assessment Series (OHSAS) 18001 management system. It notes that OHSAS 18001 was originally developed in the early 1990s as British Standard 8800 and revised in 1999 to be more compatible with ISO 14001. The document then outlines the main components of an OHSAS 18001 system, including policy, planning, implementation, checking and corrective action, and management review.

1. Gaurav Kumar
M.Pharm
Q.A (1st Year)
8/01/2014
Krupanidhi college of Pharmacy (Quality Assurance)

2. 
OHSAS 18000 is an international occupational health and safety
management system specification.
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Originally developed in early 1990’s as BS8800.
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Revised in 1999 by BSI to be more compatible with ISO 14001.
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It comprises two parts, 18001 and 18002 and embraces BS8800 and a
number of other publications.
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17 elements designed in parallel to ISO 14001 and allows third-party
certification/registration.
Krupanidhi college of Pharmacy (Quality Assurance)

3. 
An international standard like ISO 9001or ISO 14001.
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An international guideline as ICH.
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Not prescriptive –no absolute requirements; very similar to ISO 14001.
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OHSAS 18001 was created via a concerted effort from a number of the worlds
leading national standards bodies, certification bodies, and specialist consultancies.
Krupanidhi college of Pharmacy (Quality Assurance)

4. 
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BS8800:1996 Guide to occupational health and safety management systems
DNV Standard for Certification of Occupational Health and Safety Management
Systems(OHSMS):1997
Technical Report NPR 5001: 1997 Guide to an occupational health and safety management system.
Draft LRQA SMS 8800 Health & safety management systems assessment criteria
SGS & ISMOL ISA 2000:1997 Requirements for Safety and Health Management Systems
BVQI Safety Cert: Occupational Safety and Health Management Standard
Draft AS/NZ 4801 Occupational health and safety management systems Specification with guidance
for use
Draft BSI PAS 088 Occupational health and safety management systems
UNE 81900 series of pre-standards on the Prevention of occupational risks
Draft NSAI SR 320 Recommendation for an Occupational Health and Safety (OH and S)
Management System
Krupanidhi college of Pharmacy (Quality Assurance)

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National Standards Authority of Ireland.
Standards Australia.
South African Bureau of Standards.
British Standards Institution.
Bureau Veritas Quality International.
Det Norske Veritas.
Lloyds Register Quality Assurance.
National Quality Assurance.
SFS Certification.
SGS Yarsley International Certification Services.
Asociaci?spa? de Normalizaci? Certificaci?r .
International Safety Management Organisation Ltd.
Standards and Industry Research Institute of Malaysia.
International Certification Services .
Krupanidhi college of Pharmacy (Quality Assurance)

6.  OH & S policy
 Planning.
 Implementation and operation.
 Checking and corrective action.
 Management review.
 Continual improvement.
Krupanidhi college of Pharmacy (Quality Assurance)

7. 
Clearly states overall OH&S objectives.
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Authorised by top management.
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Appropriate to nature & scale of OH&S risks.
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Documented, implemented, and maintained.
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Communicated to all employees.
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Available to interested parties.
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Reviewed periodically.
Krupanidhi college of Pharmacy (Quality Assurance)

8. OH&S Policy Commitments
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Improve health & safety performance*
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Continual improvement.
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“at least” comply with current applicable .
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OH&S legislation and other requirements.
* Performance: measurable results of the OH&S management system,
related to the organization’s control of health and safety risks, based on
its OH&S policy and objectives.
Krupanidhi college of Pharmacy (Quality
Assurance)

9. OH&S Planning
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Hazard identification, risk assessment, and risk control.
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Legal and other requirements.
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Objectives
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OH&S management program(s)
Krupanidhi college of Pharmacy (Quality
Assurance)

10. Hazard Identification, Risk Assessment & Risk
Control
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Conceptually similar to environmental aspects and impacts –target of
management program(s)
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Much more detailed than 14001 approach
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Assessment must address:
– routine and non-routine activities
– all personnel, including contractors and visitors
– facilities at the workplace, whether provided by the organization or
by others
Krupanidhi college of Pharmacy (Quality Assurance)

11. Hazard Identification, Risk Assessment & Risk
Control
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Methodology must be proactive
– in advance of process/equipment changes
– allow engineering of hazard controls during design
– implementation of controls as change occurs
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Success requires strong Management of Change (MOC) procedure
Krupanidhi college of Pharmacy (Quality Assurance)

12. Hazard Identification, Risk Assessment & Risk
Control
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Process overview
– identification of hazards
– evaluation of risks under current controls
– evaluation of the tolerability of residual risk
– identification of needed additional controls
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People are involved
– significant risks must be controlled
– individual behaviour is a significant factor
Krupanidhi college of Pharmacy (Quality Assurance)

13. OH&S Planning
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14. Implementation & Operation
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Structure and responsibilities
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Training awareness and competence
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Consultation and communication
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Documentation
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Document and data control
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Operational control
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Emergency preparedness and response
Krupanidhi college of Pharmacy (Quality Assurance)

15. Structure & Responsibilities
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Documented roles, responsibilities, authorities, and accountability
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Management appointee responsible for implementation
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Resources
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Managers must demonstrate commitment to continual improvement
Krupanidhi college of Pharmacy (Quality Assurance)

16. Training, Awareness & Competence
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Ensure employee awareness and competence
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Take into account differing levels of:
– Responsibility
– Ability
– Literacy
– Risk
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Much of required training driven by regulation
Krupanidhi college of Pharmacy (Quality Assurance)

17. Consultation & Communication
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More internally focused than ISO 14001
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Employee involvement and consultation
– in development/review of policies and procedures
– about changes that affect workplace safety or health
– ensuring representation in OH&S matters
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Buy-in, ownership, motivation
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Insights of shop floor perspective
Krupanidhi college of Pharmacy (Quality Assurance)

18. Documentation & Data
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Documentation of core elements
– aids employee awareness.
– shows how the various system relate.
– extremely valuable during certification process.
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Document and data control procedures
– critical documents are available
– obsolete documents and data are removed
Krupanidhi college of Pharmacy (Quality Assurance)

19. Operational Control
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Identify operations and activities where risk requires further control
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Plan these to ensure that
– documented procedures are developed
– operating criteria specify key steps and requirements
– procedures addressing risks related to contractor goods and services
– establish design procedures to reduce/eliminate source of risks
Krupanidhi college of Pharmacy (Quality Assurance)

20. Operational Control
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21. Emergency Preparedness & Response
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Emergency response procedures to address
– identifying potential for incidents and emergencies.
– preventing and mitigating resultant illnesses and injuries.
– responding to incidents and emergencies when they occur.
Krupanidhi college of Pharmacy (Quality Assurance)

22. Emergency Preparedness & Response
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23. Checking & Corrective Action
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Performance measurement and monitoring.
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Accidents, incidents, non-conformances and corrective and preventive
action.
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Records and records management.
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OH&S management system audit.
Krupanidhi college of Pharmacy (Quality Assurance)

24. Performance Measurement & Monitoring
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Monitoring the achievement of objectives.
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Quantitative and qualitative measures.
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Proactive and reactive methods.
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Records to facilitate corrective and preventive actions.
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Calibration of monitoring equipment.
Krupanidhi college of Pharmacy (Quality Assurance)

25. Quantitative & Qualitative
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Direct Quantitative Measures
– number of lost work days following an injury.
– decibel levels of noise in a work area.
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Indirect Qualitative Measures
– review of inspection logs.
– observation of a task.
– Interviews.
Krupanidhi college of Pharmacy (Quality Assurance)

26. Proactive & Reactive Measures
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Proactive monitoring of compliance
– routine basis, independent of any event.
– monitoring may be required by regulations
• daily equipment checks.
• periodic review of hot-work permits.
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Reactive monitoring of accidents or incidents
– in response to an event or trigger
• accident investigation.
• monitoring in response to a complaint.
Krupanidhi college of Pharmacy (Quality Assurance)

27. Accident, Incidents, Non-conformances & Corrective
and Preventive Action
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Handle, investigate, mitigate
– Accidents.
– Incidents.
– non-conformances.
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Corrective and preventive actions.
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Review action plans through risk assessment process.
Krupanidhi college of Pharmacy (Quality Assurance)

28. Accident, Incidents & Non-conformances
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Handle = immediate action
– Notification.
– emergency response.
– recordkeeping to facilitate investigation.
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Investigation process.
– team and procedures.
– root cause analysis.
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People are involved
– human elements.
Krupanidhi college of Pharmacy (Quality Assurance)

29. Corrective and Preventive Action
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Correct immediate problem.
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Mitigate consequences.
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Eliminate or control root cause.
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Prevent recurrence.
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Review action plans through risk assessment process.
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Communicate results and monitor.
Krupanidhi college of Pharmacy (Quality Assurance)

30. Records & Record Management
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Identification, maintenance, and disposition
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Records must be:
– Legible.
– Identifiable.
– traceable to the activities involved.
– easily retrievable.
– protected from damage, deterioration, or loss.
– held for specified and documented retention times.
Krupanidhi college of Pharmacy (Quality Assurance)

31. OH&S Management System Audit
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Determine if OH&S-MS:
– conforms with planned arrangements.
– is properly implemented and maintained.
– is effective in meeting policy and objectives.
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Results provided to top management.
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Audit program and schedule reflect risks and previous audit results.
Krupanidhi college of Pharmacy (Quality Assurance)

32. Management Review
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33. CONCLUSION
Essentially, OHSAS helps in a variety of respects... it helps: minimize risk to
employees/etc; improve an existing OH&S management system; demonstrate
diligence; gain assurance; etc. The benefits can be substantial.
Krupanidhi college of Pharmacy (Quality Assurance)

34.  THANK YOU 
Krupanidhi college of Pharmacy (Quality
Assurance)