oshas 18001

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

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A presentation on OSHAS guidelines and its overview and importance

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Page 1: Oshas 18001

Krupanidhi college of Pharmacy (Quality Assurance)

Gaurav KumarM.PharmQ.A (1st Year)8/01/2014

Page 2: Oshas 18001

OHSAS 18000 is an international occupational health and safety

management system specification.

Originally developed in early 1990’s as BS8800.

Revised in 1999 by BSI to be more compatible with ISO 14001.

It comprises two parts, 18001 and 18002 and embraces BS8800 and a

number of other publications.

17 elements designed in parallel to ISO 14001 and allows third-party

certification/registration.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 3: Oshas 18001

An international standard like ISO 9001or ISO 14001.

An international guideline as ICH.

Not prescriptive –no absolute requirements; very similar to ISO 14001.

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)

Page 4: Oshas 18001

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)

Page 5: Oshas 18001

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)

Page 6: Oshas 18001

OH & S policy

Planning.

Implementation and operation.

Checking and corrective action.

Management review.

Continual improvement.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 7: Oshas 18001

Clearly states overall OH&S objectives.

Authorised by top management.

Appropriate to nature & scale of OH&S risks.

Documented, implemented, and maintained.

Communicated to all employees.

Available to interested parties.

Reviewed periodically.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 8: Oshas 18001

OH&S Policy CommitmentsOH&S Policy Commitments

• Improve health & safety performance*

• Continual improvement.

• “at least” comply with current applicable .

• 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)

Page 9: Oshas 18001

OH&S PlanningOH&S Planning

• Hazard identification, risk assessment, and risk control.

• Legal and other requirements.

• Objectives

• OH&S management program(s)

Krupanidhi college of Pharmacy (Quality Assurance)

Page 10: Oshas 18001

Hazard Identification, Risk Assessment & Risk Hazard Identification, Risk Assessment & Risk ControlControl

• Conceptually similar to environmental aspects and impacts –target of

management program(s)

• Much more detailed than 14001 approach

• 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)

Page 11: Oshas 18001

Hazard Identification, Risk Assessment & Risk Hazard Identification, Risk Assessment & Risk ControlControl

• Methodology must be proactive

– in advance of process/equipment changes

– allow engineering of hazard controls during design

– implementation of controls as change occurs

• Success requires strong Management of Change (MOC) procedure

Krupanidhi college of Pharmacy (Quality Assurance)

Page 12: Oshas 18001

Hazard Identification, Risk Assessment & Risk Hazard Identification, Risk Assessment & Risk ControlControl

• Process overview

– identification of hazards

– evaluation of risks under current controls

– evaluation of the tolerability of residual risk

– identification of needed additional controls

• People are involved

– significant risks must be controlled

– individual behaviour is a significant factor

Krupanidhi college of Pharmacy (Quality Assurance)

Page 13: Oshas 18001

OH&S PlanningOH&S Planning

Krupanidhi college of Pharmacy (Quality Assurance)

Page 14: Oshas 18001

Implementation & OperationImplementation & Operation

• Structure and responsibilities

• Training awareness and competence

• Consultation and communication

• Documentation

• Document and data control

• Operational control

• Emergency preparedness and response

Krupanidhi college of Pharmacy (Quality Assurance)

Page 15: Oshas 18001

Structure & ResponsibilitiesStructure & Responsibilities

• Documented roles, responsibilities, authorities, and accountability

• Management appointee responsible for implementation

• Resources

• Managers must demonstrate commitment to continual improvement

Krupanidhi college of Pharmacy (Quality Assurance)

Page 16: Oshas 18001

Training, Awareness & CompetenceTraining, Awareness & Competence

• Ensure employee awareness and competence

• Take into account differing levels of:

– Responsibility

– Ability

– Literacy

– Risk

• Much of required training driven by regulation

Krupanidhi college of Pharmacy (Quality Assurance)

Page 17: Oshas 18001

Consultation & CommunicationConsultation & Communication

• More internally focused than ISO 14001

• 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

• Buy-in, ownership, motivation

• Insights of shop floor perspective

Krupanidhi college of Pharmacy (Quality Assurance)

Page 18: Oshas 18001

Documentation & DataDocumentation & Data

• Documentation of core elements

– aids employee awareness.

– shows how the various system relate.

– extremely valuable during certification process.

• Document and data control procedures

– critical documents are available

– obsolete documents and data are removed

Krupanidhi college of Pharmacy (Quality Assurance)

Page 19: Oshas 18001

Operational ControlOperational Control

• Identify operations and activities where risk requires further control

• 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)

Page 20: Oshas 18001

Operational ControlOperational Control

Krupanidhi college of Pharmacy (Quality Assurance)

Page 21: Oshas 18001

Emergency Preparedness & ResponseEmergency Preparedness & Response

• 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)

Page 22: Oshas 18001

Emergency Preparedness & ResponseEmergency Preparedness & Response

Krupanidhi college of Pharmacy (Quality Assurance)

Page 23: Oshas 18001

Checking & Corrective ActionChecking & Corrective Action

• Performance measurement and monitoring.

• Accidents, incidents, non-conformances and corrective and preventive

action.

• Records and records management.

• OH&S management system audit.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 24: Oshas 18001

Performance Measurement & MonitoringPerformance Measurement & Monitoring

• Monitoring the achievement of objectives.

• Quantitative and qualitative measures.

• Proactive and reactive methods.

• Records to facilitate corrective and preventive actions.

• Calibration of monitoring equipment.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 25: Oshas 18001

Quantitative & QualitativeQuantitative & Qualitative

• Direct Quantitative Measures

– number of lost work days following an injury.

– decibel levels of noise in a work area.

• Indirect Qualitative Measures

– review of inspection logs.

– observation of a task.

– Interviews.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 26: Oshas 18001

Proactive & Reactive MeasuresProactive & Reactive Measures

• 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.

• 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)

Page 27: Oshas 18001

Accident, Incidents, Non-conformances & Corrective and Preventive Action

• Handle, investigate, mitigate

– Accidents.

– Incidents.

– non-conformances.

• Corrective and preventive actions.

• Review action plans through risk assessment process.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 28: Oshas 18001

Accident, Incidents & Non-conformances

• Handle = immediate action

– Notification.

– emergency response.

– recordkeeping to facilitate investigation.

• Investigation process.

– team and procedures.

– root cause analysis.

• People are involved

– human elements.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 29: Oshas 18001

Corrective and Preventive Action

• Correct immediate problem.

• Mitigate consequences.

• Eliminate or control root cause.

• Prevent recurrence.

• Review action plans through risk assessment process.

• Communicate results and monitor.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 30: Oshas 18001

Records & Record Management

• Identification, maintenance, and disposition

• 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)

Page 31: Oshas 18001

OH&S Management System Audit

• Determine if OH&S-MS:

– conforms with planned arrangements.

– is properly implemented and maintained.

– is effective in meeting policy and objectives.

• Results provided to top management.

• Audit program and schedule reflect risks and previous audit results.

Krupanidhi college of Pharmacy (Quality Assurance)

Page 32: Oshas 18001

Management Review

Krupanidhi college of Pharmacy (Quality Assurance)

Page 33: Oshas 18001

Krupanidhi college of Pharmacy (Quality Assurance)

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.

Page 34: Oshas 18001

THANK YOU

Krupanidhi college of Pharmacy (Quality Assurance)