This document describes the risk of a potential flash fire during sieving of combustible powders in the soft gelatin area of a GSK site in Egypt. The risk is due to insufficient controls of static electricity generation during sieving and the proximity of an electric panel. The proposed mitigation plans include applying engineering controls to manage static electricity such as installing earthing cables, dissipative sheeting and gaskets, and removing the adjacent electric panel. Implementing these controls aims to prevent serious worker injuries from a possible flash fire event and ensure business continuity.

1. GlaxoSmithKline - Egypt Appendix 6 to SOP TO 524/10
RISK SITUATION, TARGET AND PROPOSAL (STP) Page 1 of 6
Originating Site: Cairo Risk Identifier. Risk Internal No.:
Date of Issue: 15/9/2016 STP Ref. No.: Version: 01
RISK TITLE
Include brief, specific and clear title of the risk. The risk title should state the hazard/risk event and its major impact.
Potential flash fire during Sieving combustible powders in soft gelatin area due to insufficient controls of staticelectricity and adjacent
electric panel which might lead to operator severe burns and business interruption
RISK OWNER DETAILS
Name:
Yasser Mahdy
Job Title:
VS Head
Department:
Manufacturing
RISK STP DOCUMENT APPROVAL
Completion of the following signature block signifies that the approver has read, understands, and agrees with the content of this document.
ROLE/JOB TITLE NAME SIGNATURE DATE
STP AUTHORS:
The Author signs as having prepared this version of the risk STP in accordance with Company Policies
Risk Owner: Yasser Mahdy
Mitigation Plan 1 Owner: Helmy Ismail
Mitigation Plan 2 Owner: Amr Younis
STP APPROVERS:
Signs as agreeing with the content of this STP, with reference to the scope, background, analysis, scoring and mitigation det ails and authorizing this document as
a source for details of the described risk and for introduction into the site risk register
Head of EHS and Area of
Impact Responsible:
Sherine Zaki
Engineering / Capital
Head
Ayman El Leissy
GMS Cairo Site Director: Najib Chabaa

2. GlaxoSmithKline - Egypt Appendix 6 to SOP TO 524/10
RISK SITUATION, TARGET AND PROPOSAL (STP) Page 2 of 6
Originating Site: Cairo Risk Identifier. Risk Internal No.:
Date of Issue: 15/9/2016 STP Ref. No.: Version: 01
SITUATION
RISK DESCRIPTION
Describe the existing or potential risk hazard/event, the main cause of this hazard or event and the ultimate impact of the risk (on business, compliance, safety,
quality……)
Potential flash fire during Sieving combustible powders (Biotin , Nicotinamide & Ascorbic acid ) in soft gelatin area due to insufficient
controls of staticelectricity ,
The above 3 components represent the fire triangle by Which
-Fuel will be Combustible powder and related dust generated from thesieving process
-Ignition source will be Heat generated at the mesh surface of the sieve, Electrostatic charges from the operator, Sparks from adjacent
electric panel, all are liable to occur.
-Oxygen , exist in the normal atmosphere
It is also worth to mention that for a fire to occur there must be sufficient concentration of thefuel ignited by enough energy of the ignition
source.
With no machine controls related to the Russell sieve used except for general earthing , and No controls on operator electrostatic charges
, Moreover electric hazard from adjacent control panel which is not properly sealed with possibility of dust accumulation inside the panel .
This might lead to flash fire that will cause operator severe burns and business interruption.
BACKGROUND INFORMATION
Describe the details behind seeing or considering this problem as a risk. State facts or statistics that support this risk, and refer to potential events might happen.
Refer or attach relevant supporting references whenever appropriate. The following questions may be answered to cover a risk background:
• How did you discover the presence of this risk?
Risk was discovered after conducting Process safetyassessmentcovering manufacturing sieving processes and was also
highlighted in Sieving departmental risk assessment.
Moreover , several GEMBA done on the process pointed to the high level of dustassociated with this process ,this can be
noticed over the walls surrounding the process ,Control panel , Electric sockets

3. GlaxoSmithKline - Egypt Appendix 6 to SOP TO 524/10
RISK SITUATION, TARGET AND PROPOSAL (STP) Page 3 of 6
Originating Site: Cairo Risk Identifier. Risk Internal No.:
Date of Issue: 15/9/2016 STP Ref. No.: Version: 01
• What mightgo wrong? How is it different from the normal/standard?
• Accumulation of static charges during the sieving process especially , This will be liable to occur during the manufacturing
of ( Haemoton – Supravit – Vitamax)
Material * Minimum ignition energy(mj)
Biotin 60
Nicotinamide 15
Ascorbic Acid 12
*Minimum ignition energy (mj) The lowest energy of a discrete spark that is capable of igniting a dispersed dust
 Due the nature of the sieving process , it is likely to generate heatat the sieve location that mightignite dustvapor
accumulated in the surrounding area ,It was also noticed thatthere is a Dustextraction system above the sieving location
which need to be reviewed regarding efficiency and suitability.
• Where will be the risk found? When will it occur? Why mightthings go wrong?
At Soft Gelatin area , Sieving room during the sieving of the ( Haemoton – Supravit – Vitamax) , Severe burns to the
operator from the expected flash fire .
• What is the extent or scope of the risk?
GSK operators handling sieving process in softgelatin area
• How mightthis risk impactthe business?
Serious injuries due to severe burns will affect site personnel moral and impactthe business due to losttime expected for
one or multiple employees.
Incidents/Accidents: e.g. non-conformities, complaints, rejects, deviations, accidents, serious events,….
EHS – ENG Alert 12 -011 (Low Humidity suite dust ignition )
12-011GMS Eng- EHS
Sydney Powder Ignition .docx(12-011).docx
Gaps against standards or requirements: Attach reference to gap analysis
- GES 202 (Prevention and control of DustExplosions )
- Hazardous area classification done on site at 2012 and did not include Sieving process in Soft Gelatin area
44NK9034.P01.0001
-ANNEXURE-7.3 SOFT GEL CAPSULES - Vita max.pdf
Audit observation: Attach reference
 L1  L2  L3  L4
N/A
Other tools used in identification of this risk: Specify and attach references
- Process safety HAZID assessment
- Departmental risk assessment for Sieving process
HAZID Sieving at
Soft Gelatin .xlsx
DRA Sieving and
milling in Soft Gelatin processing area (2).docx

4. GlaxoSmithKline - Egypt Appendix 6 to SOP TO 524/10
RISK SITUATION, TARGET AND PROPOSAL (STP) Page 4 of 6
Originating Site: Cairo Risk Identifier. Risk Internal No.:
Date of Issue: 15/9/2016 STP Ref. No.: Version: 01
EXISTING CONTROLS
Describe all currently applied measures that ensure putting the stated risk under certain level of control
- Dustextraction system presentlevel of control regarding notreaching high dustaccumulation over the sieve.
- Sieve head is covered to minimize dustrelease
- Sieve body is earthed
- Electric panel is closed all over the process
- Good air change in the room ( 10-15 ACH)
- Operator understanding for the hazard while joining all the assessments .
EXISTING MONITORING
Describe all currently applied techniques, procedures or systems that are used to monitor the progress in the level of the stated risk
- GEMBA at the location
- ZAPs
- Escalation to EHS Council
RISK EVALUATION
Include here all details that support your risk scoring exercise
Initial Risk Score
Risk Area of Impact Consequence Statement Consequence
Score Likelihood Statement Likelihood
Score RIV
 Business - Cost
 Business - Reputation
 Business - Supply
 Environment,Health & Safety Severe burn or tissue damage 4
May see severalincidents
during w orking life
2 8
 Product Quality
 Quality Compliance
 Other Compliance
Comment on initial risk score:
N/A
Current Score: Severe burn or tissue damage 4
May see severalincidents
during w orking life 2 8
Comment on current risk score:
ROOT CAUSE ANALYSIS
Include here the results of root cause analysis of the stated risks
Ref. Root Cause Category
RC01 Insufficient control of static electricity in Sieving process Process
RCO2 Insufficient design assessment for both Control Panel and existing Suction hood Design
Comment on root cause analysis:
N/A

5. GlaxoSmithKline - Egypt Appendix 6 to SOP TO 524/10
RISK SITUATION, TARGET AND PROPOSAL (STP) Page 5 of 6
Originating Site: Cairo Risk Identifier. Risk Internal No.:
Date of Issue: 15/9/2016 STP Ref. No.: Version: 01
TARGET
IDEAL SOLUTION SPECIFICATIONS
State the criteria that need to be fulfilled by the ideal solution to this risk. You may select from the below stated criteria or specify new criteria
 Address identified rootcause/s
 Complywith local regulations
 Complywith companystandards/rules
 Achievable within acceptable timeframe
 Realistic and adequatelyresourced
 Sustainable and preventrecurrence
 Other criteria: please specify:
EXPECTED BENEFITS
State the benefits that will be gained when the below proposed solution is implemented
Prevent serious injuries to GSK employees atSoft Gelatin area
PROPOSAL
PROPOSED SOLUTION OPTIONS
Specify options proposed to mitigate this risk. Specify the scope of each option and its impact. Specify the selected options.
-Apply engineering controls to achieve high level of control on static electricity ( Earthing cable - Dissipative sheet - Sieve
Dissipative gaskets –Ground monitor.
-Remove adjacentcontrol panel
AGREED RISK MITIGATION PLANS
Specify the details of agreed mitigation plans
Mitigation Plan 1:
Mitigation Plan Description
Mitigation Plan
Owner
Due Date
Root Cause
Ref.
Apply engineering controls to achieve high level of control on static
electricity
Helmy Ismail July 2017 RC01
Mitigation Action Plans:
ID Action Plan Description Action Plan Owner Due Date Status
1 Issue CCR for the proposed changes in the room. Helmy Ismail Oct 2016
2 Install earthing bar in the room Mohamed El Hosary Nov- 2016
3 Avail 2 FM Approved Earthing clamps in the sieving room Amr Younis Jan-2017
4
Install ST ST earthed sheetwith suitable size for operator to
stand on
Amr Younis Jan-2017
5 Get offers for Ground monitor Helmy Ismail Dec-2016
6 Issue PO for ground monitor Helmy Ismail Jan-2017
7 Install Ground Monitor in the Sieving room Helmy Ismail May-2017
8 Replace Sieve gaskets with dissipative gaskets Amr Younis Apr- 2017
9
Review Sieve earthing continuity to comply with EHS ENG Alert
12-002
Amr Younis
Dec-2016
10
Update Sieving operation SOP to include all added controls and
provide training to all operators accordingly
Helmy Ismail June-2017
11
Include dustextraction system in site preventive maintenance
plan
Kirollos Kamel Jan-2017
12
ConductAAR for the completed risk actions and update HAZID
assessmentaccordingly
Ahmed Mohamed
Said
July-2017

6. GlaxoSmithKline - Egypt Appendix 6 to SOP TO 524/10
RISK SITUATION, TARGET AND PROPOSAL (STP) Page 6 of 6
Originating Site: Cairo Risk Identifier. Risk Internal No.:
Date of Issue: 15/9/2016 STP Ref. No.: Version: 01
Mitigation plan comments:
Mitigation Plan 2:
Mitigation Plan Description
Mitigation Plan
Owner
Due Date
Root Cause
Ref.
Assess the design and location of both the existing control
Panel and the dust extraction system
Ahmed Mohamed
Said
Jan-2017 RC02
Mitigation Action Plans:
ID Action Plan Description Action Plan Owner Due Date Status
1 Assess the location ofthe control panel as per area HAC zoning
Ahmed Mohamed
Said
Dec-2016
2
Assess the performance ofthe existing Suction hood with
Versus manufacturing specs.
Kirollos Kamel Nov-2016
3
Assess the current performance ofthe suction hood against
operation requirements
Ahmed Mohamed
Said
Jan-2017
Mitigation plan comments:
MITIGATED INDEX VALUE
Include here all details that support your risk scoring after completing the proposed mitigation plans
Risk Area of Impact Mitigated ConsequenceStatement Mitigated
Consequence
Mitigated Likelihood Statement Mitigated
Likelihood MIV
EHS Severe burn or tissue damage 4 Probability of incident is rare 1 4
Comment on mitigated index value:
MITIGATION PLAN RSOURCES
Specify the details of resources required to execute the agreed mitigation plans
Financial Resources: Value Currency Payment Year
 OPEX
 Budgeted
40.000 LE 2016 Not budgeted
 CAPEX
 Budgeted
N/A Not budgeted
Other Resources: Specify details of or reference to non-financial resources needed to complete the agreed mitigation plans
RISK MITIGATION COMPLETION DATE:
Rationale to changes in risk mitigation completion date (if any):
Document History:
Date Version Reason for Revision Ref.
01 First issue N/A