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 TITLEInclude 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 static electricity and adjacent electric panel which might lead to operator severe burns and business interruption

RISK OWNER DETAILSName:

Yasser MahdyJob Title:

VS HeadDepartment:

Manufacturing

RISK STP DOCUMENT APPROVALCompletion 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 details 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

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 DESCRIPTIONDescribe 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 static electricity ,

The above 3 components represent the fire triangle by Which -Fuel will be Combustible powder and related dust generated from the sieving 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 the fuel 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 INFORMATIONDescribe 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 safety assessment covering 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 dust associated with this process , this can be noticed over the walls surrounding the process , Control panel , Electric sockets

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 might go 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 15Ascorbic 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 heat at the sieve location that might ignite dust vapor accumulated in the surrounding area , It was also noticed that there is a Dust extraction 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 might things 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 soft gelatin area

• How might this risk impact the business?

Serious injuries due to severe burns will affect site personnel moral and impact the business due to lost time 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 ) Gaps against standards or requirements: Attach reference to gap analysis- GES 202 (Prevention and control of Dust Explosions ) - Hazardous area classification done on site at 2012 and did not include Sieving process in Soft Gelatin area

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

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 CONTROLSDescribe all currently applied measures that ensure putting the stated risk under certain level of control

- Dust extraction system present level of control regarding not reaching high dust accumulation over the sieve. - Sieve head is covered to minimize dust release- 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 MONITORINGDescribe 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 EVALUATIONInclude here all details that support your risk scoring exercise

Initial Risk ScoreRisk 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 several incidents during working 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 several incidents during working life 2 8

Comment on current risk score:

ROOT CAUSE ANALYSISInclude here the results of root cause analysis of the stated risks Ref. Root Cause CategoryRC01 Insufficient control of static electricity in Sieving process ProcessRCO2 Insufficient design assessment for both Control Panel and existing Suction hood Design

Comment on root cause analysis:N/A

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 SPECIFICATIONSState 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 root cause/s

Comply with local regulations

Comply with company standards/rules

Achievable within acceptable timeframe

Realistic and adequately resourced

Sustainable and prevent recurrence

Other criteria: please specify:

EXPECTED BENEFITSState the benefits that will be gained when the below proposed solution is implementedPrevent serious injuries to GSK employees at Soft Gelatin area

PROPOSAL

PROPOSED SOLUTION OPTIONSSpecify 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 adjacent control panel

AGREED RISK MITIGATION PLANSSpecify 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 Status1 Issue CCR for the proposed changes in the room. Helmy Ismail Oct 20162 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 sheet with 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 dust extraction system in site preventive maintenance plan Kirollos Kamel Jan-2017

12 Conduct AAR for the completed risk actions and update HAZID Ahmed Mohamed July-2017

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

assessment accordingly SaidMitigation 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 of the control panel as per area HAC zoning Ahmed Mohamed Said Dec-2016

2 Assess the performance of the existing Suction hood with Versus manufacturing specs. Kirollos Kamel Nov-2016

3 Assess the current performance of the suction hood against operation requirements

Ahmed Mohamed Said Jan-2017

Mitigation plan comments:

MITIGATED INDEX VALUEInclude here all details that support your risk scoring after completing the proposed mitigation plans

Risk Area of Impact Mitigated Consequence Statement Mitigated Consequence Mitigated Likelihood Statement Mitigated

Likelihood MIVEHS Severe burn or tissue damage 4 Probability of incident is rare 1 4

Comment on mitigated index value:

MITIGATION PLAN RSOURCESSpecify the details of resources required to execute the agreed mitigation plansFinancial 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