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Regulation Class Document Class

Procedure Main Document

Regulation Title

Medical/Occupational Health Audit

Topic
Standard requirements of a medical/occupational health audit

Objective
To define the medical/OH audit procedure in order to provide a uniform basis and guidance for
medical/OH audits which shall assess, examine, verify, evaluate and determine whether medical units
in OMV Group comply with OMV Corporate HSSE Standards Operational Health (HSSE-S-011) and
Health Management (HSSE-S-012) and all approved health work procedures.

Target Group
Operative medical service providers within OMV Group

Scope of Effectiveness
OMV Aktiengesellschaft and all companies which are fully consolidated. In companies not fully consolidated,
where OMV Aktiengesellschaft has a controlling interest. All stock corporations are excluded with the result that
these regulations have to be separately enforced in these entities.

Responsible for Content: GTR-H Günther Niemeck


Org. Unit First- Last Name Signature Date

Regulation Approver 1: GTR-H Susanne Schunder-Tatzber


Org. Unit First- Last Name Signature Date

Regulation Approver 2: GT-R Andreas Scheed


Org. Unit First- Last Name Signature Date

As approved by the Executive Board of: not applicable


Date

Effective as of: 15.01.2013


Date

In the interests of simplicity and readability, the language of this statement is gender neutral to the extent possible. Where
applicable, the masculine includes the feminine. Print-out is only valid on the date printed. Check for the latest version in the
Regulations Platform. In case of conflict, the document in its Master Language must be applied.

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Index of content
1. Introduction & Intended Purpose of Regulation .............................................................. 3
2. Content of Regulation ......................................................................................................... 3
2.1. Basics ...........................................................................................................................3
2.1.1. Basic philosophy ..............................................................................................3
2.1.2. Definitions .........................................................................................................3
2.2. Audit Content ..............................................................................................................3
2.3. Responsibilities ...........................................................................................................4
2.4. Audit Team Competencies ........................................................................................4
2.4.1. General Experience of Auditors ......................................................................4
2.4.2. Audit Team Leader ...........................................................................................4
2.4.3. Auditees ............................................................................................................5
2.4.4. Training of OMV OH auditors .........................................................................5
2.4.5. Expenses related to training and development activities ............................5
2.5. Medical/OH Audit Process .........................................................................................5
2.5.1. Pre-Audit ...........................................................................................................5
2.5.1.1. Administration well in advance of the audit..................................................5
2.5.1.2. Administration immediately prior to the audit..............................................6
2.5.2. Performing the Audit .......................................................................................6
2.5.2.1. Opening meeting ..............................................................................................6
2.5.2.2. Conducting the audit .......................................................................................7
2.5.2.3. Closing meeting(s) ...........................................................................................7
2.5.3. Post Audit ..........................................................................................................7
2.5.3.1. Reporting:..........................................................................................................7
2.5.3.2. Tracking and closure: .......................................................................................7
2.6. Evaluation of Performance ........................................................................................7
2.7. Frequency of Audits ...................................................................................................8
2.8. Expenses related to audits.........................................................................................8
3. Internal Reference Links ..................................................................................................... 8
4. External Reference Links .................................................................................................... 8
5. Obsolete Regulations.......................................................................................................... 8
6. Certification Standards ....................................................................................................... 8
7. Terms & Abbreviations ....................................................................................................... 8
8. Keywords / Search Criteria ................................................................................................. 9
9. Annexes ................................................................................................................................ 9
10. Amendments from Previous Versions ......................................................................... 9

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1. Introduction & Intended Purpose of Regulation

The purpose of this Corporate Work Procedure is to describe the main principles, the roles and
responsibilities of occupational health examinations within OMV Group.

2. Content of Regulation

2.1. Basics

2.1.1. Basic philosophy


Line and health/medical management shall assure that the approved Corporate HSSE
Standards Operational Health (HSSE-S-011) and Health Management (HSSE-S-012) and the
health work procedures are being properly implemented.

Audits are an essential tool to verify whether management system in place is effective. The
aim of any audit shall be to check whether pre-determined standards are being complied
with and, if not, to provide a basis for improvement. Audits shall be planned carefully in
order to derive maximum benefit from the auditing process.

This document makes use of suggested questions and model answers, providing a clear
indication of expected performance standards. The questions and answers have been
designed in such a way that appropriate scores can be assigned to each question. This
approach makes it possible to compare the performance of various medical/OH units and
monitor the improvement or deterioration over a period of time.

All audits are valuable in highlighting strengths as well as identifying any shortcomings and
thus helping to determine priorities for action. In principle, medical/OH audits are no
different than audits of any other activity. Such audits should be linked wherever possible, a
process that offers advantages for all concerned. For example, health audits can be linked to
safety audits, integrated into health, safety and environmental audits or conducted as part of
quality management audits. Any potential synergies should be exploited wherever possible.
See also Corporate HSSE Standard HSSE Management System Audit.

2.1.2. Definitions
OH Audit: A formal, team-based activity used to provide independent assurance that the
medical units comply with Corporate HSSE Standards Operational Health (HSSE-S-011) and
Health Management (HSSE-S-012).

OH lead auditor: A medical doctor who is trained in medical/OH auditing and appointed by
the HMD to lead the audit and to manage and coordinate the audit process.

OH auditor/audit team member: A medical doctor who is trained in medical/OH auditing and
appointed by the HMD to take part in the audit.

Auditee: The senior MD of the medical unit that is being audited.

2.2. Audit Content

The medical/OH audit shall provide insight on the status of the implementation of Corporate
HSSE Standards Operative Health (HSSE-S-011) and Health Management (HSSE-S-012) and
other relevant approved WPHs/WPEs and for this purpose the medical/OH audit shall check
these elements through a combination of:

► Review of the documentation to provide assurance that the documentation of


procedures, controls and arrangements in place is suitable and compliant with the
standards mentioned above and related work procedures;

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► Interview with selected key management and staff to provide assurance that the
requirements of this documentation are understood and that management is committed
to compliance;
► Clinic checks to provide assurance that the audit is being effectively implemented via
medical/OH inspections of medical facilities (for cleanliness/hygiene, drugs not past their
expiration dates and stored correctly, etc.).

2.3. Responsibilities

The management of the business organization /subsidiary shall support the audit process by
reviewing and endorsing audit findings and being committed to take action to address them.
Management shall be prepared to be interviewed by the audit team to provide evidence of the
integration of the medical/OH team and OH in general into the overall management scheme.
Auditees shall support the audit process by providing relevant documentation, openly
participating in interviews and facilitating field visits to allow for a realistic view of the operation
to be obtained.
Audit team leaders shall be broadly familiar with Corporate HSSE Standards Operational Health
(HSSE-S-011) and Health Management (HSSE-S-012) and the related Work Procedures. They
shall have sufficient and relevant operational experience to ensure that the team identifies all
material concerns and is able to communicate findings in a manner that will facilitate
acceptance and ownership by the management of the business segment or unit/subsidiary.
Audit team members shall have an understanding of the operations/activities being audited.

2.4. Audit Team Competencies

2.4.1. General Experience of Auditors


Selection of personnel for participation in audits shall be made on the basis of the
qualifications and experience of the medical/OH auditor.
Qualifications: While good auditing skills can be developed, there are some qualifications of
the person that aid in the performance of the auditors’ duties. These qualifications can be
acquired but generally build on the innate skills of the person, such as:

► Excellent oral and written communications


► Good listener
► Capable presenter
► Willingness to travel
► Ability to work within a team and willingness to support other team members
► Respect of clients and peers

Experience: While experience can be obtained when performing audits, the overall program
benefits from the utilization of personnel who are experienced in the operations that they will
be auditing. Ideally, the individual(s) selected for the auditing team shall have most of the
experience listed below:

► OH specialist or company doctor


► Auditing experience
► HSSE experience or an understanding of the issues – working in the oil industry for
many years

2.4.2. Audit Team Leader


Basic competency requirements are as follows:

► Previous auditing experience, including a minimum of two OMV Group audits as a


team member
► Management or supervisory experience (minimum of two years)
► Independent of the business organization /subsidiary being audited

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The primary mechanism for training audit team members to become audit team leaders shall
be on-the-job training. The operational and/or management criteria for audit team leaders
can be relaxed provided that sufficient on-the-job training has been carried out.

2.4.3. Auditees
Auditees shall have a basic awareness about an audit processes.

2.4.4. Training of OMV OH auditors


OH auditors shall be trained by a certified auditing institution and given a basic
understanding of the general principles of audits, a proper understanding of the
requirements of this procedure and some hands-on training in an audit scenario.

2.4.5. Expenses related to training and development activities


In general, training expenses shall be paid by the organizational unit in which the trainee is
employed.

2.5. Medical/OH Audit Process

2.5.1. Pre-Audit

2.5.1.1. Administration well in advance of the audit


The following shall be agreed upon with the business organization/subsidiary well in
advance (ideally at least two months) of an audit in order to give the auditees time to
prepare documents, have personnel available and ensure that the audit is not performed
during critical operations:

► Scope: Predetermine what will be within the scope of the audit and what will be
outside the scope. For example, a medical/OH audit of a business organization
/subsidiary may not physically go to every location within the business.

► Required background information: The business organization /subsidiary shall


agree to provide some or all of the following:
► A brief description of the facilities or operations being audited
► Medical/OH performance data including performance dates (i.e. number of
consultations, vaccinations, etc.)
► Any known instances of non-compliance with regulations
► A list of instances of non-compliance identified by the previous audit and
documentation to demonstrate how they have been rectified
► Organizational charts and names of key individuals
► List of regulatory permits and reports
► Comprehensive overview of the legal regulations relevant for OH

► Dates and duration of the audit: Typically, a medical/OH audit of a business


organization /subsidiary might involve:
► Preparation / planning / scheduling – send out information, specify
preparation requirements for auditee, coordination of meetings etc.
► Around five days at the business organization /subsidiary comprising the
following: head office interviews and documentation review, travel to/from the
field and field inspections (two days where applicable) and further reviews,
checks and a wrap-up meeting at the head office;

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► Around one week to prepare the draft of the audit report.

► Single contact person: Confirm the identity of a single contact person that will
accompany the audit team throughout the time they are at the location. This person
will be expected to serve as a liaison with the audit team and provide specific
information on products or processes, the location of permits and records, and
gather other similar basic raw data.

2.5.1.2. Administration immediately prior to the audit


Just prior (ideally around one week) to the audit prepare and agree the following with the
business organization/subsidiary:
► Detailed audit schedule: This shall provide a detailed daily breakdown of the audit
showing the time allocated for collective team activities (i.e. morning briefing and
evening analysis meetings) as well as interviews, site visits and document reviews.
It shall be ensured that all persons required are available.
► Briefing memo: This shall be prepared by the audit team leader and submitted to
the relevant medical officer for distribution to all staff who will be involved with the
audit in any way. The purpose of the memo is to advise the affected personnel of
the impending audit and to outline the approach to be taken, the audit itinerary, the
personnel to be contacted and the required facilities. The briefing memo shall form
the basis for the preliminary meeting and by supporting this, the relevant manager
and medical officer encourages the staff to fully cooperate with the audit team in
order to facilitate the performance of the audit.
► Audit checklists: These identify the information the audit team is looking for and the
type of questions that may be asked during interviews. Sharing them with the
business organization/subsidiary in advance allows auditees to be fully prepared
and maximizes the efficiency of audits. The objectives for each of the elements
listed in Appendix A shall always be used as the basic checklist, and there is
generally no need to use any other information (for consistency and ease of use).

2.5.2. Performing the Audit

2.5.2.1. Opening meeting


The start of every audit shall begin with an opening meeting with management and staff
to review the purpose and expectations of the audit in order to alleviate any concerns the
auditees may have. This meeting is designed to develop a dialog between the auditees
and the audit team. The following items shall be addressed during this meeting:
► Introduction of the audit team
► Make roles clear regarding both parties – auditors and auditees
► The purpose of the audit and authority under which it is being conducted
► The advantages of conducting the audit
► Any concerns of the auditee
► The audit process and how it will be executed
► Confirmation of the final details of the audit, itinerary, schedule of interviews, etc.
► What the audit report will look like and how the follow-ups will be conducted
► Schedule of events during the audit
► Request for working areas, organizational charts and other documents required,
permission to take photographs and access to all areas of the facility
► Confidentiality of reports
► Introduction of staff with whom the audit team will interact

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2.5.2.2. Conducting the audit
This activity shall obviously constitute the majority of the time for the audit. The actual
audit process shall begin with a review of relevant documentation (i.e. documented
processes, practices and procedures - see last column in the Audit Checklist - Annex)
followed by interviews of key personnel. If time permits or if specific issues arise during
the review of documents or the interviews, inspections of specific physical locations may
be required.

2.5.2.3. Closing meeting(s)


In the course of the audit, the audit team members shall prepare an informal summary
report of any material findings relevant to that operational site and discuss it with the
affected medical officer and local management before leaving any operational site. This
advance notification regarding any critical deficiencies will allow action to be taken by the
line manager together with medical officer as quickly as possible. It also allows the audit
team to confirm the correctness of their interim findings. Possible recommendations can
also be discussed.
This presentation at the conclusion of the audit is of great importance in attempting to
ensure that no information is missed, verifying the correctness of findings and
recommendations, and thus in getting the auditee to "buy in" to findings and
recommendations. Sufficient time shall be allocated in the audit schedule to ensure the
success of this activity.
Prior to leaving the business organization/subsidiary, the team shall hold a final closing
meeting in which all of the instances of non-conformity that will be in the audit report are
identified. This report shall not contain any surprises for the business
organization/subsidiary.

2.5.3. Post Audit

2.5.3.1. Reporting:
The audit team leader shall be responsible for documenting the audit findings in the audit
report and shall complete and forward the audit report to the auditees for comments
within three weeks of the conclusion of the audit. The auditees shall have two weeks to
comment, identify any disputed items and report a schedule for the correction of all
agreed items addressed in the report. Distribution of this draft of the report shall be
limited to the specific auditees and the management of the relevant business organization
/subsidiary.

2.5.3.2. Tracking and closure:


Following up on the action items that arise in the audit is probably the most important
aspect of the entire audit process: this is the responsibility of the business
segment/subsidiary’s management and not of the audit team. Each medical/OH team
together with local management shall develop and maintain local procedures which detail
the arrangements for the allocation of responsibilities, action tracking, action review and
communication to the workforce. This following up on recommendations, actions and
implementations shall be recorded in a tracking register. The senior MD of the BS shall
track the status of the findings of each audit report and requires quarterly status reports
from the auditees until all items have been rectified.

2.6. Evaluation of Performance

A set of questions with a scoring system was developed for the evaluation of performance (see
Annex A – Audit Checklist). The responses to these questions and scores are useful in

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identifying any deficiencies that require action as well as in indicating areas of strength within
OH/health services.
The scoring system makes it easier to compare findings with previous audits, thus highlighting
the extent of any improvements or deteriorations in performance.

The following scoring system is used for OMV Group medical/OH audits:
Score 0 – Immediate action needed
Score 1 – Major deficiencies
Score 2 – Minor deficiencies
Score 3 – Fully compliant

Topics and questions are weighted according to their importance.


Comparison of audit scores for different clinics and locations may be used to demonstrate what
is achievable, as may benchmark with other units.

2.7. Frequency of Audits

Every clinic shall conduct a self-assessment using the checklist provided in Annex A by the end
of Q1 and report the scores, major findings and the action plan to the senior MD of the BS.
Clinics shall be audited by a medical/OH auditor who is independent of the BS at least every
three years.

Depending on special needs and circumstances, the senior MD of the BS shall decide on the
frequency of internal medical/OH audits.
These audits shall be planned and integrated into the Health Management Plan of the sites and
of the BS and the findings shall be reported by the senior MD of BS to the Corporate HMD.
Random audits may be performed by the Corporate HMD or a medical/OH auditor appointed by
them in order to ensure an integrative link between HMD and the OH team – such audits shall
be communicated in accordance with the requirements defined in this work procedure as well.

2.8. Expenses related to audits

Expenses related to the audits (i.e. travel costs for OH auditors) shall be borne by the BS being
audited. In order to avoid excessive travel costs, an alignment with other travel activities shall
be considered (i.e. training programs, attendance of medical conferences, BS-wide meetings).

3. Internal Reference Links

HSSE Directive Health Management (HSSE-D-003)


Corporate HSSE Standard Health Management (HSSE-S-012)
Corporate HSSE Standard Operational Health (HSSE-S-011)

4. External Reference Links

Local legal provisions on occupational health


OSHAS 18001

5. Obsolete Regulations

6. Certification Standards

7. Terms & Abbreviations

HMD Health Management Department

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OMSP Operative Medical Service Provider
OH Occupational Health
MD Medical Doctor
HSSE Health, Safety, Security and Environment
BS Business Segment
BU Business Unit
HR Human Resources
OH Audit A formal, team-based activity used to provide independent
assurance that the medical units comply with Corporate HSSE
Standards Operational Health (HSSE-S-011) and Health
Management (HSSE-S-012).
OH lead auditor A medical doctor who is trained in medical/OH auditing and
appointed by the HMD to lead the audit and to manage and
coordinate the audit process.
OH auditor/audit team A medical doctor who is trained in medical/OH auditing and
member appointed by the HMD to take part in the audit.
Auditee The senior MD of the medical unit that is being audited.

8. Keywords / Search Criteria

Medical Audit, Quality Audit, Occupational Health, Health Management, Operative Medical
Services, HSSE

9. Annexes

Annex A: Audit checklist / questions


Annex B: Audit report
Annex C: Checklists OH clinic / First Aid
Annex D: Action Plan

10. Amendments from Previous Versions

Date of Regulation
Changes to previous versions:
effectiveness: code:
02.01.2009 WPH 18 Medical/Occupational Health Audit

15.01.2013 HSSE-P-024 Revision after Reshaping

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Annex A: Audit checklist / questions

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Annex B: Audit report

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Annex C: Checklists OH clinic / First Aid

Site Clinic (internal) Company/Site:


First Aid Point
(internal) Contact:
OH Med.Center
(internal) Eval. made by: Date:
OH Med.Center
(external)
Excellent
Adequate
Needs improvement
Low performance
Not applicable

rig /restrictive
operative site
office site
(>50p)

area
1 General requirements and furniture
Intermediate care ● ● ●
Triage area ● ● ●
Identification of clinic ● ● ●
Accessibility of clinic (stretchers, ambulance car, …) ● ● ●
Large enough (access examination couch) ● ● ●
Communication (mobile phone, ...) ● ● ●
Lighting sufficient ● ● ●
Fire extinguishers ● ● ●
Intimacy assured ● ● ●
Room temperature control (cooling and heating) ● ● ●
Water supply (hot, cold) ● ● ●
Examination table ● ● ●
Stretcher or patient transfer sheet ● ● ●
Drip stand or hook (for infusions) ● ● ●
Desk, 2 chairs, stainless steel rubbish bin ● ● ●
Refrigerator ● ● ●
Sterilizer ● ● ●

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rig /restrictive
operative site
office site
(>50p)

area
2 Curative equipment
Weighing scale ● ● ●
Otoscope ● ● ●
Medical thermometer ● ● ●
Stethoscope ● ● ●
Reflex hammer ● ● ●
Blood pressure machine ● ● ●
Resting E.C.G ● ●
Ergometry equipment (bicycle ergometer) ● ●
Spirometer ● ●
Audiometer ● ●
Sight test equipment (Screening device) ● ●
Vene catheters, butterfly ● ● ●
Finger splint ● ● ●
Cold-hot packs ● ● ●
Wood tongue depressor ● ● ●
Gloves – disposable gloves ● ● ●
Gloves surgical sterile ● ● ●
Isothermical blanket ● ● ●
Needle, one way ● ● ●
Magnetic eye probe ● ● ●
Scalpel handle standard ● ● ●
Scissors ● ● ●
Stainless container for instruments ● ● ●
Disposable shaving razor ● ● ●
Infusion sets ● ● ●
Sterile syringes ● ● ●

3 Bandage and dressings / wound management


Burn kit, burn shield ● ● ●
Sterile gauze ● ● ●
Sterile eye pad ● ● ●
Wound disinfection (iodine …) ● ● ●
Tensoplast bandage ● ● ●
Cotton bandage ● ● ●
Elastic bandage ● ● ●
Wound ointments ● ● ●
Plaster ● ● ●
Wound foil ● ● ●

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operative site
rig /restricted
office site

area
4 Emergency equipment / Trauma – portable!
Vacuum mattress ● ●
Suction unit ● ●
Defibrillator with ECG and monitor ● ●
Disposable thoracic drainage system ● ●
Respirator, sun ● ●
Oxygen bottle, oxygen system (manometer) ● ●
Oxygen Mask ● ●
Dead body bag ● ●
Triage cards ● ●
Pulsoxymeter ● ●
Laryngoscope, Intratracheal tubes ● ●
Stiff neck & splints ●
Surgical gloves sterile ●
Surgical masks ●
Suture sets or similar ●
Tracheotomy set ●
Spine board ●
Vacuum mattress ●
Chest drainage ●

5a Drug - supply and management


List of medicine and materials available ● ● ●
Adequate quantities and qualities (peroral, dermal, inhal., injections) ● ● ●
Appropriate places and conditions for storage of medicine ● ● ●
Controlled drugs –temperature, shelf life etc. ● ● ●

5b Drugs – peroral, inhal., dermal


Cortisol spray ● ● ●
Sedation ● ● ●
Wound ointments ● ● ●
Antibiotics ● ● ●
Aspirin and similar ● ● ●
Eyes Ears Nose drops ● ● ●
Ant allergic medication ● ● ●
Anti-diarrhea ● ● ●
Sore throat medication ● ● ●
Pain killers ● ● ●

5c Drugs – Injection, Infusions, Vaccinations


Infusions ● ● ●
Vaccinations ● ● ●
Pain management ● ● ●

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6 Laboratories / drug storages
General condition of room (large enough, lightning, ventilation)
blood sample zone
Photometer
Glucometer
Urine sticks
Malaria quick test

7a First aid kits professionals – equipment


Bag
Butterfly needles and vein catheters
Bandage rolls 5x5
Sterile gauzes
Sterile disposable needles
Sterile infusion set
Sterile syringes
Disinfectant solution (alcohol, iodine or similar)
Burnkit
7b First aid kits professionals – emergency drugs
Cortisone (> 100 mg)
diuretics, i.e. furosemide
antiphylactic drugs
drugs for resuscitation – i.e. Adrenaline
drugs for treating acute respiratory disorders - like Theophylline
drugs treating nausea – like Metoclopramide
drugs treating psychiatric problems – like Diazepam, Haloperidol
drugs to treat server pains – i.e. Tramadol
antiarrhythmic drugs – like Lidocaine, Verapamil, Amiadarone
drugs to treat hypertension and/or cardiac ischemia -i.e. Nitro
drugs for relaxation, sedation (i.e. Ketamine, Diazepam,
Haloperidol)
Infusions (hypovolemia) – i.e. Ringer lactate
7c First aid kits for non-professionals at worksite
up to 10p

up to 20p
dust – proofed kits
green cross on white ground
local legal requirements met
sufficient kits, cleanliness
Rescue sheet, silver/gold insulating foil 1 2
bandage, elastic, constraining 2 4
bandage, gauze, elastic, non-sterile 2 4
bandage, triangular 2 4
compress, gauze, ster., 2 pcs 6 15
dressing, FA, aluminized, sterile 1 3
dressing, adhesive bandage, wound plaster 1 2
glove, examination, latex, non-sterile 6 10
mask, protection, mouth-to-m. resuscitation,
reusable 1 1
scissor, sharp-blunt 1 1
disinfectant solution (alcohol, iodine …) 1 1

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7d kits for non-professionals at vehicles
1 Rescue sheet, silver/gold insulating foil
1 bandage, elastic, constraining
2 bandage, gauze, elastic, non-sterile
2 bandage, triangular
6 compress, gauze, ster., 2 pcs
1 dressing, FA, aluminized, sterile
1 dressing, adhesive bandage, wound plaster
4 glove, examination, latex, non-sterile
1 mask, protection, mouth-to-m. resuscitation, reusable
1 scissor, sharp-blunt
1 disinfectant solution (alcohol, iodine …)

8 First aiders
First Aiders, number (>10% of personnel on site /> 5% offices )
First Aiders, training of (16 h basic/ 4 h refreshers every two
years)
First Aiders, quality ( perform resuscitation and First Aid )
First aid kits-non-profs, number

9 Office site up to 50 employees


Consultation - non-permanent room (confidence maintained, i.e. meeting room)
lockable storage for medical histories etc.

Annex C to HSSE-P-024 Master Language: English


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Annex D: Action Plan

Reference
Topic Problem Proposed Action Responsible Due Date

Signature

Annex D to HSSE-P-024 Master Language: English


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Version: 2.0

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