Occupational Health and Safety

Occupational Health and Safety

SCOPE

• This Occupational Health and Safety manual specifies requirements for an Occupational Health and Safety (OH&S) management system (ISO 45001:2018), to enable the Any Industry to control its OH&S risks and improve its OH&S performance.
• This manual helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization’s OH&S policy, the intended outcomes of an OH&S management system include:
• a) Continual improvement of OH&S performance;
• b) Fulfilment of legal requirements and other requirements;
• c) Achievement of OH&S objectives.
• The Occupational Health and Safety Management System in Any Industry is applicable to the processes / activities required in the manufacture of the following pharmaceutical products.
• It is proposed to manufacture Specified products. The scope of this manual is applicable from receipt of Raw and Packing materials, Processing (Manufacturing, Packing, and Analysis etc.), Storage and Dispatch of finished product.
• As the safety vision, implementation of occupational health & safety management system is one of the most important subject of mankind and shall positively contribute to realization of occupational health and safety management system. Any Industry wishes to establish an OH&S management system to eliminate or minimize risks to personnel and other interested parties who could be exposed to OH&S hazards associated with its activities.
• Reference to the procedures that are involved in the operation of the system.

Normative Reference

ISO 45001, occupational health and safety management system

International Labour Organization:2001, Guideline on Occupational Health and Safety Management Systems (OSH-MS)

Terms and definitions:

Term	Definition
Acceptable risk	Risk that has been reduced to a level that can be tolerated by the organization having regard to its legal obligations and its own OH&S policy.
Audit	Systematic, independent and documented process for obtaining “audit evidence” and evaluating it objectively to determine the extent to which “audit criteria” are fulfilled
Continual Improvement	Recurring process of enhancing the OH&S management system in order to achieve improvements in overall OH&S performance consistent with the organization’s OH&S policy.
Corrective action	Action to eliminate the cause of a detected nonconformity or other undesirable situation.
Document	Information and its supporting medium.
Hazard	Source, situation, or act with a potential for harm in terms of human injury or ill health, or a combination of these.
Hazard identification	Process of recognizing that a hazard exists and defining its characteristics.
Ill Health	Identifiable, adverse physical or mental condition arising from and/ or made worse by a work activity and/ or work related situation.
incident	Work-related event(s) in which an injury or ill health (regardless or severity) or fatality occurred, or could have occurred.
Interested party	Person or group, inside or outside the workplace, concerned with or affected by the OH&S performance of an organization.
Nonconformity	Non-fulfilment of a requirement.
Occupational health and safety (OH&S)	Conditions and factors that affect, or could affect, the health and safety of employees or other workers (including temporary workers and contractor personnel), visitors, or any other person in the workplace.
OH&S management system	Part of an organization’s management system used to develop and implement its OH&S policy and manage its OH&S risks.
OH&S objective	OH&S goal, in terms of OH&S performance that an organization sets itself to achieve.
OH&S performance	Measurable results of an organization’s management of its OH&S risks.
OH&S policy	Overall intentions and directions of an organization related to its OH&S performance as formally expressed by top management
Organization	Company, corporation, firm, enterprise, authority or institution, or part or combination thereof, whether incorporated or not, public or private, that has its own functions and administration.
Preventive action	Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.
Procedure	Specified way to carry out an activity or a process
Record	Document stating results achieved or providing evidence of activities performed
Risk	Combination of the likelihood of an occurrence of a hazardous event or exposure(s) and the severity of injury or ill health that can be caused by the event or exposure.
Risk assessment	Process of evaluating the risk(s) arising from a hazard(s) taking into account the adequacy of any existing controls, and deciding whether or not the risk(s) is acceptable.
Workplace	Any physical location in which work related activities are performed under the control of the organization.

Understanding the needs and expectations of workers and other interested parties

• Hazard identification and Risk assessment and determination of controls will be with appropriate participation and consultation of workers and other interested parties. Workers consultation is also a part of accident or incident investigation.
• Workers or person performing work or work-related activities that are under the control of the organization.
• Interested parties are person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity of the organization.
• OH&S policy and objectives will be developed in co-ordination with all employees, workers and other interested parties. Changes also a subject to discuss with all employees, workers and contractors.

Leadership and worker participation

• Top management of Industry   takes accountability for the effectiveness of the OH&SMS and provides resources to ensure that the OH&S Policy and OH&S Objectives Are Compatible with the strategic direction and the context of the organization.
• Top management has the power to delegate authority and provide resources within the
• organization, provided ultimate responsibility for the OH&S management system. 
• Top management refers to those who direct and control that part of the organization. Top management shall demonstrate leadership and commitment with respect to the OH&S management system by:
• Taking overall responsibility and accountability for the prevention of work-related injury and ill health, as well as the provision of safe and healthy workplaces and activities.
• Ensuring that the OH&S policy and related OH&S objectives are established and are compatible with the strategic direction of the organization.
• Ensuring the integration of the OH&S management system requirements into the organization’s business processes.
• Ensuring that the resources needed to establish, implement, maintain and improve the OH&S management system are available.
• Communicating the importance of effective OH&S management and of conforming to the OH&S management system requirements.
• Ensuring that the OH&S management system achieves its intended outcomes.
• Directing and supporting persons to contribute to the effectiveness of the OH&S management system;
• Ensuring and promoting continual improvement.
• Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
• Developing, leading and promoting a culture in the organization that supports the intended outcomes of the OH&S management system.
• Protecting workers from reprisals when reporting incidents, hazards, risks and opportunities.
• Ensuring the organization establishes and implements a processes for consultation and participation of workers.
• Supporting the establishment and functioning of Environment, health and safety committees.

EHS Policy

Evaluate all the processes for Environmental & Safety effects and to minimize the potential risk.

Committed to prevent Environment and performance.

Work with our suppliers and customers towards ensuring full lifecycle responsibility to our products.

Review our Environmental protection on a regular basis and develop and implement procedures to ensure continuous improvement.

Develop and implement Risk Control incentives to minimize the potential consequences of accident and emergency situations.

Committed to comply with applicable legal requirements and with other requirements to which the organization subscribe that relate to its Environment hazards.

Establish objectives and targets to secure continual Environment protection improvements.

EHS policy is communicated to all persons working under the control of the organization with the intent that they are made aware of their individual Environmental protection.

Policy is available to interested parties and is reviewed periodically to ensure that it remains relevant and appropriate to the organization.

EHS Policy is displayed at different location within the plant premises and is available to interested parties on request. 

Organization roles, responsibilities and authorities

Top management is ensuring that the responsibilities and authorities for relevant roles within the OH&S management system are assigned and communicated at all levels within the organization and maintained as documented information.

Responsibility on OH&S is mentioned in department HOD’s and second line job description which percolates all person working in the departments.

The Organization Top Management is ultimate responsible for OH&S management system. The following roles and responsibilities have been designated for the control of the occupational health and safety management system operating under ISO 45001.

Consultation and participation of workers

The Industry shall:

Provide mechanisms, time, training and resources necessary for consultation and participation.

Provide timely access to clear, understandable and relevant information about the OH&S management system.

Determine and remove obstacles or barriers to participation and minimize those that     cannot be removed.

Worker are involved in EHS committee and any one can report any OH&S Issues.  Worker are also involved in the investigation of accident and incident. Many programs are under conducted to involved the shop floor employees such as safety week celebration.

The participation of workers in the following way:

Determining the mechanisms for their consultation and participation.

Identifying hazards and assessing risks and opportunities.

Determining actions to eliminate hazards and reduce OH&S risks.

Determining what needs to be communicated and how this will be done.

Determining control measures and their effective implementation and use.

Investigating incidents and nonconformities and determining corrective actions.

Planning

Actions to address risks and opportunity

General

Industry has determined risk & opportunity related to OH&S, compliance obligation, context of the organization identified and the internal & external issues. Requirements of interested parties and determine the risks and opportunities that need has been addressed

a) Give assurance that the OH&S management system can achieve its intended outcomes

b) Prevent, or reduce, undesired effects

c) achieve continual improvement

While determining the risks and opportunities for the OH&S management system and its intended outcomes that has been addressed, the INDUSTRY shall take into account:

Hazards

OH&S risks and other risks

OH&S opportunities and other opportunities

Legal requirements and other requirements

The organization, in its planning processes, shall determine and assess the risks and opportunities that are relevant to the intended outcomes of the OH&S management system associated with changes in the organization, its processes or the OH&S management system. In the case of planned changes, permanent or temporary, this assessment shall be undertaken before the change is implemented

The organization shall maintain documented information on:

Risks and opportunities;

The processes and actions needed to determine and address its risks and opportunities

to the extent necessary to have confidence that they are carried out as planned.

Hazard identification, assessment of risks and opportunities

Industry identify the Hazards and risk assessment on all the process and activity performed in the organization, accordingly controls measures have been taken. The Hazard identification. Industry shall ensure that it is up-to-date and that hazards identification and risk assessment with significant impacts are considered in setting OH&S objectives, and identifying capital projects.

Determination of legal requirement and other Requirements

The organization has established, implemented and maintained a procedure to

Determine and have access to up-to-date legal requirements and other requirements that are applicable to its hazards, OH&S risks and OH&S management system.

Determine how these legal requirements and other requirements apply to the organization and what needs to be communicated.

Taken these legal requirements and other requirements into account when establishing,

implementing, maintaining and continually improving its OH&S management system.

Planning actions

Industry shall have planned the following action for effective implementation of OH&S Management system:

Identified the risks and opportunities

Prepared legal requirements and other requirements

Prepare On -site Emergency Plan for respond to emergency situations

Integrate and implement the actions into INDUSTRY OH&S management system processes or other business processes.

Evaluation the effectiveness of the step taken.

The Industry shall take into account the hierarchy of controls and outputs from the OH&S management system when planning to take action.

OH&S objectives and planning to achieve them

OH&S objectives

When necessary revision of the objectives, based on the result of the internal audits, external audit and other interested party’s consultation to be done.

Following points are taken into consideration for setting OH&S objectives   -

Establish and maintain an OH&S management system that facilitates a structured approach to the management of occupational risk.

Provide adequate human, financial and time resources to ensure the effectiveness and sustainability of the system.

Keep up-to-date with relevant health and safety legislative obligations. Achieve and maintain compliance with these obligations.

Promote a safety culture that encourages people to proactively manage Occupational health and safety risk through education, instruction, information and supervision.

Clearly define and communicate Employees, Visitors, Vendors, Customers and Contractors responsibilities in relation to Occupational health and safety.

Proactively identify and manage health and safety risk via a documented hazard identification, risk assessment, risk control and monitoring process.

Improve processes that ensure that incidents and hazards are promptly reported, investigated where appropriate, and control measures are put in place to eliminate or minimize the chance of a repeat event.

Routinely monitor and review EHS performance to achieve continual improvement.

Planning to achieve OH&S objectives

Industry has determined following step when planning how to achieved OH&S objectives -

what will be done;

what resources will be required;

who will be responsible;

when it will be completed;

How the results will be evaluated, including indicators for monitoring;

How the actions to achieve OH&S objectives will be integrated into the INDUSTRY   business processes.

Support

Resources

Industry has determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the OH&S management system. Top management is responsible for ensuring the availability of resources essential to   establish, implement, maintain and improve the OH&S management system.

Competence

Heads of Departments are responsible for identifying the needs conducting professional training of the employees regarding OH&S. The Industry   have:

Determined the necessary competence of employees to work at predetermined workplace.

Ensured that workers are competent on the basis of appropriate education, training or experience,

where applicable, take actions to acquire and maintain the necessary competence, and evaluate the effectiveness of the actions taken;

Competency matrix of all the employees are maintained.

It is ensured by senior personnel that any person(s) under its control performing tasks that can impact on OH&S is competent on the basis of appropriate education, training or experience and shall retain associated records. All activities are cross monitored by senior personnel.

Occupational Health & Safety information and training is provided to new hires during their induction. Periodic information and training is also provided during routine safety meetings.  On the job training ensures that employees perform their job tasks in a safe and responsible manner.

Forms of training

Training is both, In-house and external.   In house training includes “Classroom” and “On the job” training. On the job training helps actual simulation of work environment and is very helpful.  External training will be planned as and when required, it is need based.

Assessment of efficacy of training

Training is followed by evaluation of employees for effectiveness of training.  The Trainer carries out evaluation of training through questionnaires or oral discussions and observations at the place of work.

Identification of re-training needs

All the trainings will be rescheduled at defined intervals as per the Training plan as a refresher.   Besides, if on evaluation it is felt that employee requires additional training, itis planned.  Records of Re-training will be maintained in individual training file.

Awareness

Employees should aware of:

The OH&S policy and OH&S objectives

Their contribution to the effectiveness of the OH&S management system, including the benefits of improved OH&S performance;

The implications and potential consequences of not conforming to the OH&S management system requirements;

Incidents and the outcomes of investigations that are relevant to them;

Hazards, OH&S risks and actions determined that are relevant to them;

The ability to remove themselves from work situations that they consider present an imminent and serious danger to their life or health, as well as the arrangements for protecting them from undue consequences for doing so.

Awareness regarding OH&S management system through Training, EHS committee meeting awareness programs. Training needs of the personnel are identified by the respective department head, on the basis of nature of activity performed by the employee.

Communication

General

Industry have employee’s interaction and any employee, visitors and contractor.

Internal Communication

Organization has several formal and Informal methods of communication for the internal discussion of OH&S issues and concerns.  Bulletin boards and e-mail are used to inform employees. Industry   stresses its “open door” policy for employees to informally raise issues and concerns.

External Communication

Communications from external sources are directed to the Quality Assurance Department/HR.  Documentation is maintained by the Quality Assurance Department.

Documented information

General

Documentation for the control of the occupational health & safety management system is held by EHS Head.  OH&S policy is developed and approved by Top Management. Objectives are deciding on the basis of Hazard Identification and Risk Assessment Controls and standard procedures for control also developed on the basis of Hazard Identification and Risk Assessment.

SOP’s relate directly to the requirements of ISO 45001. Standard Operating Procedures provide information for carrying out operational tasks and may give rise to documentation for precise control. Quality Records are generated from both SOP’s.

Creating and updating

Quality Assurance (QA) is responsible for distribution, revision and authorization of the quality documents. EHS Head is responsible for creation of the OHSAS documents, any updating in the relevant document through change control. 

Control of documented information

The documents are controlled as per the SOP on document control. This SOP defines the procedure for preparation and handling of documents. All the master documents have a specific format. The master documents are controlled by QA for OHSAS documents.

Quality Assurance retains all the master documents. Master documents are stored under lock and key by QA and management representative. For distribution, “Xerox copy of Master document” is taken. All the pages of the Xerox are stamped as “Controlled copy” in red with sign & date, entry is made in the “Document Distribution Record” and documents are distributed to the respective department.

For sending the document to an outside customer or Regulatory body, Xerox copy of the documents is stamped as “Uncontrolled copy”.

If a document is revised, all the existing copies of the document are retrieved by the Quality Assurance and destroyed. The master copy of the document is stamped in red as “Obsolete” across each page and stored in “Obsolete documents file”.

Operation

Operational planning and control

The occupational health and safety management program elements are reviewed annually by the EHS Head and/or other appropriate employees, and changes made as necessary.  A schedule of these reviews is included in the Occupational Health and Safety Program in Management Review Meetings.

General

The operations of the manufacturing and associated processes in the organization are controlled by SOP’s.  Occupational Health and Safety concerns may be addressed by including them in these SOP’s. Contractors are made aware of OH&S consideration through their contractor orientation.

Eliminating hazards and reducing OH&S risks

Internal audit and Hazards and identification are done through which all the work place hazards are identified after that necessary action is taken to avoid by elimination or by reducing effect of hazards.

Management of Change

All the changes are gone through change control management system through proper approval.

Procurement

All the procurement gone purchase department who verify safety and quality of material. Each equipment installed by third party goes for qualification in which safety features and occupational health aspect are checked and recorded.

Emergency preparedness and response 

The Onsite Emergency Plan is to be established for the facility. Mock drills on this Emergency preparedness organized. It is formally reviewed and updated annually, and on a periodic basis as needed.

Performance Evaluation

Monitoring, measurement, analysis and performance evaluation

General

Activities of monitoring and measurement refer to the qualitative and quantitative measures.

All the monitoring related to OH&S is done by external parties and the calibration of critical instrument done as per their schedule.

If equipment for internal monitoring and measurement is used, it will be calibrated by the third party.

The on-going performance of the company, compliance with OH&S legislation, reporting of the hazard identification and risk assessment of the operations and the monitoring of targets, communications and improvements are achieved by means of advice of the Head EHS.

The EHS Department updates significant activities regularly; this information is forwarded to senior staff of Industry.

Analysis and evaluation

Industry   analyses and evaluates appropriate data and information arising from monitoring and measurement. The results of analysis are used to evaluate:

Conformity of products and services;

Degree of worker satisfaction;

Performance and effectiveness of the OH&S Management System;

Planning has been implemented effectively;

Effectiveness of actions taken to address risks and opportunities;

Performance of external service providers;

Need for improvements to OH&S Management System

Evaluation of compliance

Industry   has established, implemented and maintained a processes needed to evaluate fulfilment of its compliance obligations.

Industry has:

Determined the frequency that compliance will be evaluated;

Evaluates compliance and takes action if needed;

Maintains knowledge and understanding of its compliance status.

Internal Audit

General

To ensure the compliance of the activities across the organization internal audits are conducted. Internal audit is carried out by a cross functional with EHS team from different departments at a frequency of once in six months.

Internal Audit Programs

The findings of the inspections are discussed with the concerned department head and Corrective and Preventive actions are decided.  Head of the concerned department informs the compliance action plan to EHS Head with target dates of completion. EHS Head keeps a track of the compliances made.  The compliances made against the previous inspection are verified during next inspection.

A report of the inspections along with Non-compliances and corrective actions made is submitted to the Management. Records of the inspections are maintained with EHS Head.

Management Review

Industry determines and selects opportunities for improvement and implements any necessary actions to meet OH&S requirements and enhance plant safety. These includes:

Improving safety features and services to meet requirements as well as to address future needs and expectations regarding OH&S;

Correcting, preventing or reducing LTI;

Improving the performance and effectiveness of the OH&S Management System.

Incident, nonconformity and corrective action

Incident Investigation

Head EHS will review and investigate the incidents happened in organization. The incident investigation will be based on

Determining underlying OH&S deficiencies and other factors that might be causing or contributing to the occurrence of incidents.

Identify the need for corrective action

Identify opportunities for preventive action

Identify the opportunities for continual improvement

Communicate the results of such investigation.

Nonconformity, Corrective action and Preventive action

The EHS Head will utilize the company nonconformity, corrective action and preventive   action databases for:

Identifying and correcting nonconformity and taking action to mitigate their OH&S consequences,

Investigating nonconformity determining their cause and taking actions in order to avoid their recurrence,

Evaluating the need for action to prevent nonconformity and implementing appropriate actions designed to avoid their occurrence,

Recording and communicating the results of corrective action and preventive action taken

Reviewing the effectiveness of corrective action and preventive action taken

Actions taken shall be appropriate to the magnitude of the problems and the OH&S impacts encountered.

Continual improvement

Industry continually improves the suitability, adequacy and effectiveness of the Occupational Health & Safety Management system. It considers the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.