You dont have javascript enabled! Please enable it! EHS-090 Occupational Medical Support Procedure for a GMP Site Pharmaceuticals quality assurance & validation procedures GMPSOP

EHS-090 Occupational Medical Support Procedure for a GMP Site

DepartmentEnvironmental, Health and SafetyDocument noEHS-090
TitleOccupational Medical Support Procedure
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date: 

1. AFFECTED PARTIES

All Environment, Health and Safety personnel

2. PURPOSE

The purpose of this procedure is to provide all existing and potential colleagues with the information they need to comply with the procedures for preventative occupational medical evaluation and control in compliance with local requirements and EHS guidelines.

3. SCOPE

This procedure applies to all existing and proposed new colleagues to facilitate preventative occupational medical evaluation and control in order to:

3.1 Determine a colleague’s fitness to work in a job through the assessment of the significance of past or current medical conditions.

3.2 Ensure the presence of a disability in a colleague does not compromise the well-being or safety of themselves or others.

3.3 Establish a baseline from which to measure deviations in occupational medical findings.

3.4 Review the control of exposure to reproductive hazards to minimise the risk of development of adverse reproductive effects.

3.5 Review all colleagues who are required to wear respiratory protection in the normal course of their work. This includes new and existing employees if their roles change.

3.6 Review all colleagues who are required to drive forklifts in the normal course of their work. This includes new and existing employees if their roles change.

3.7 Monitor the exposure to specific chemical and physical agents at work through the measurement of agents or their metabolites in body tissue or fluids, or the detection of health effects at an early stage. This information to be reviewed annually prior to annual medicals and all information to be passed along to OHS physician.

4. RESPONSIBILITY \ BUSINESS RULES

4.1 OHS Coordinator:

To coordinate and facilitate occupational medical support. To evaluate, identify and assist with the implementation of control strategies for both work area and individual needs.

To review all medical assessments conducted to ensure that the colleague / candidate is not at risk by any disability that may have been identified.

To ensure all medical records are safely stored and access is not freely available.

4.2 Managers and Team Leaders:

Are responsible to ensure all colleagues support and participate in this procedure and to notify the EHS Department of any noticeable changes in a colleague’s condition or any proposed move to another department / job role.

4.3 Colleagues:

To participate in the routine occupational medical evaluations and identify concerns at other non-routine times when occupational medical concerns/issues arise.

4.4 Human Resources Department:

Will be responsible for arranging the Pre placement and annual medical assessments. The Human Resource department shall liaise with the EHS Department regarding the outcomes of this assessment.

5. PROCEDURE

5.1 Baseline Occupational Medical Evaluations

5.1.1 All colleagues / candidates are required to participate in a pre-placement medical assessment if they are applying for positions as Sales representatives or Manufacturing employees directly involved in the manufacturing process, use of respirators and/or drive forklifts.

5.1.2 No offer of permanent employment is to be considered or offered to any colleague until they have undertaken a pre-placement medical assessment and the results of which are discussed between the OHS and Rehabilitation Co-ordinator and the HR representative who arranged such medical, and if required the appropriate Department Manager.

5.1.3 This assessment is to be conducted as part of the normal pre-placement selection process.

5.1.4 The Human Resource department shall arrange for all selected candidates to attend a pre-placement medical examination. This will be conducted by the nominated Occupational Physician. This is to determine the medical and physical fitness of a potential colleague for the position applied for.

5.2 Job / Position Transfer Health Assessment

5.2.1 In the case of a colleague who has undertaken a Pre-placement or annual Health Assessment in the past year, the Occupational Health Safety and Rehabilitation Coordinator shall review the health assessment to determine the necessity of repeating it after receiving the completed request for Health Assessment form.

5.2.2 A job transfer health assessment shall be performed by the approved medical person and arranged by the Manager and co-ordinated with the Rehabilitation Co-ordinator when:

5.2.2.1 Any colleague is being transferred to another department.

5.2.2.2 Any colleague is to be transferred to an alternate position, which involves a significant change in work location, hours of work, physical demands or chemical exposures other than transfer within office environments unless the new position is significantly different to the current position held.

5.2.2.3 Any colleague that is to be transferred to jobs where specific exposures may occur or health consideration applies.

5.3 Periodic Occupational Medical Evaluations

5.3.1 It is a requirement of ongoing employment that all colleagues will cooperate with attending and participating in the appropriate medical assessments.

5.4 Medical Records

5.4.1 Medical details contained in Health Assessments shall not be disclosed without the colleague’s written consent unless a court order applies or disclosure is specifically required by legislation. Records to be kept locked in personal medical files in first aid room. Access to this file is limited to the Occupational Medical Support Personnel.

5.4.2 Medical records are to be kept for entire time that colleague is employed and 30 years after they cease employment.

5.5 Health and Safety Program

5.5.1 Review hazard assessments and workplace risk characterisation reports for substances in the workplace, as provided by the facility colleague responsible for industrial hygiene.

5.5.2 Evaluate the need for follow up or further investigation after comparison of the above information with the medical records of colleagues working with the substances

5.5.3 Provide feedback to facility health and safety colleagues regarding work related cases that warrant further investigation

5.5.4 File copies of the above information with colleague medical records and ensure that the occupational physician is aware of the information.

5.6 Reports

5.6.1 The Occupational Health and Safety Coordinator shall provide written results of the assessment to the colleague if requested.

5.6.2 The Occupational Health and Safety Coordinator shall provide group reports, excluding the confidential information, to the responsible manager, if there are any anomalies in the assessments.

5.7 Colleagues Returning from Extended Sick Leave or Recovering from Significant Injury or Illness

5.7.1 The manager must provide the certifying Doctor or the Occupational Health Safety and Rehabilitation Co-ordinator with details of duties to be performed by the colleague on a return from extended sick leave or a significant injury and obtain a medical clearance to return to work. This is a requirement should the colleague be off work for more than 15 consecutive days.

5.8 Medical Fitness to Continue

5.8.1 A “fitness to continue” medical assessment will be organised to determine if a colleague is fit for their normal duties. This may become necessary for a colleague that has had excessive sick leave, or if some concern exists over an identified medical condition, which may affect the health and safety of the colleague or their co-workers.

5.8.2 This assessment shall be undertaken following review of a colleague’s medical history and sick leave record.

5.8.3 The manager shall liaise with the Rehabilitation Co-ordinator, and the Human Resource department. The colleague will be kept appraised of all and any results that are obtained pertaining to their health and general fitness for work.

5.9 Negative Health Assessment Results

5.9.1 Pre-placement Health Assessment

5.9.1.1 Immediately upon receiving the results of the pre-placement health assessment (which indicate that the candidate or colleague may have a disability or pre-existing condition) the OHS Co-ordinator will contact the Human Resource colleague who is coordinating the recruitment. The Occupational Physician will discuss any adverse results to the candidate at the medical assessment.

5.9.1.2 The Health Assessment results are passed onto the colleague by the Occupational Physician. The Occupational Physician will refer the candidate on to their own doctor for further advice.

5.9.2 Periodic Health Assessment

5.9.2.1 At the time of the assessment, the Occupational Physician will discuss any adverse results with the colleague.

5.9.2.2 Within three working days of the health assessment being received a meeting should be convened between the supervisor, the Human Resources colleague and the colleague. At the meeting the company representative should explain.

5.9.2.2.1 That the company has a concern over the apparent disability;

5.9.2.2.2 The company’s concern is that the (continued) performance of the job may expose that colleague to adverse health consequences;

5.9.2.2.3 Health and Safety is the primary concern of the company.

5.9.2.3 Information from the colleague relating to the management of the disability is necessary.

5.9.2.4 The purpose of the meeting is to determine whether any appropriate changes either to the method of health management or the circumstances of the position can be overcome, and whether the candidate / colleague should be placed in the position of concern.

5.9.2.5 If the meeting does not result in a resolution then the matter should be sent back to the Company, who will obtain legal advice in relation to the colleague’s disability and the position.

6. DEFINITIONS / ACRONYMS

N/A

7. SUMMARY OF CHANGES

Version #Revision History
EHS-090New