AC introduce riscuri

SURSA CAUZA TERMEN suplimentare?

Audituri si inspectii Om Ianuarie 2014 Da

Inspectii autoritati si grup, FM Echipament Februarie 2014 Nu

PASS Proceduri Martie 2014

CSSM Materiale Aprilie 2014
Analiza efectuata de management Metoda de control Mai 2014

Complianta:
Actiuni standarde
Cerinte legale
Meeting-uri n/a Iunie 2014
Analiza de cauza Iulie 2014
Evaluari de risc. Evaluari aspecte -
probleme mari August 2014
Lloyd's Septembrie 2014
Octombrie 2014
Noiembrie 2014
Decembrie 2014
Ianuarie 2015
Februarie 2015
Martie 2015
Aprilie 2015
Mai 2015
Iunie 2015
Iulie 2015
August 2015
Septembrie 2015
Octombrie 2015
Noiembrie 2015
Decembrie 2015
Ianuarie 2016
Februarie 2016
Martie 2016
Aprilie 2016
Mai 2016
Iunie 2016
Iulie 2016
August 2016
Septembrie 2016
Octombrie 2016
Noiembrie 2016
Decembrie 2016
Ianuarie 2017
Februarie 2017
Martie 2017
Aprilie 2017
Mai 2017
Iunie 2017
Iulie 2017
August 2017
Septembrie 2017
Octombrie 2017
Noiembrie 2017
Decembrie 2017
OBSERVATII
Verificarea implementarii se face in primele 10 zile ale lunii urmatoare de
catre EHS-ist de serviciu

In cadrul HSE Committee in ziua de lunia ultimei saptamani din fiecare luni:
va fi transmisa managerilor lista de actiuni pe urmatoarele 2 luni
managerii vor prezenta statusul actiunilor pt luna curenta
In cazul proiectelor (ex PASS) si a cerintelor Corporate & FM nu avem cauza si
nici corectie sau actiune corectiva ci doar ACTIUNE
Solutia se completeaza pt categoriile unde nu este identificata cauza
Nu se pune cauza la corectie, ci doar la actiuni corective

Actualizarea bazei de date (CAPA) se face in maxim 10 zile ale lunii urmatoare
 CAPA 2016

DESCRIERE: 1. SOLUTIE DOVADA

'- NECONFORMITATE
SURSA DEPARTAMENT DATA 2. CORECTIE TERMEN2 RESPONSABIL IMPLEMENTARII/
'- SITUATIE 3. ACTIUNE CORECTIVA STATUS
'- PROIECT

Nu este documentata obligatia de spalare a mainilor la iesirea Actualizare instructiuni de lucru privind
Audituri si inspectii PPVm 07.03.2016 Decembrie 2016 Manager PPVm
din zona de productie. echiparea/dezechiparea personalului

Nu toate carucioarele au rotile in stare buna. Se manipuleaza cu Inlocuire roti deteriorate

Audituri si inspectii PPVM iunie 2016 Decembrie 2016 Badea Alina
dificultate.
Decembrie Finalizarea reparatiilor rotilor tuturor
CSSM PPVm Reparatii roti carucioare Ianuarie 2017 Alina Badea
2016 carucioarelor defecte din PPVm.
 EFICACITATE doar
ISTORIC TERMEN pentru AC
 Site Zentiva Romania (Pharma Solids)
BUSINESS Industrial Affairs > Pharma Solids > Zentiva Romania (Pharma Soli
Audit date 04.05.2015-08.05.2015

N° REQUIREMENT TYPE FINDING DESCRIPTION

1 103 - Management
commitment
Minor A safety week on fall slip trip has been
carried out recently. Staircases have
been explicitly addressed. Employees
have been encouraged to address
observations. However, no exchange
of LEX with handrails in staircases
from one department to another. One
location was observed in good
condition and at least two other
staircases with 4 steps without any
handrail.
In addition, several people have been
observed during the audit not using
the sign posted handrail and even
worth some of them used the cell
phone at the same time.

2 201 - HSE risk Optimization A risk assessment process is in place

assessment and these assessments are verified on
an annual basis.
The existing risk maps are showing
identified risks without corrective
actions which are in place. The maps
have to be updated to show current
risks which employees have to face.
In the emergency preparedness plan
earth quake is mentioned as a major
site risk. However, this is not part of
the overall risk map.

3 203 - The pass
Optimization The site has a PASS program in place
and a follow up process is in place
including communication.
However, there is nothing about long
term action plan (e.g. Water/CO2/API
management)
4 204 - Site HSE Minor The dashboard exists and a follow up
performance process is in place.it is reviewed
indicators dashboard monthly the “LEAN’s meeting” and
quarterly during the “SAFETY
committee” meeting.
The Strat plan dashboard is only
known by top management, and by
concerned employees (Energy team).
In addition, the audit observed:
- The company objectives (target)
have to be defined (Ok for LTI, but
what about water and CO2) and
communicated at the dashboard.
- The communication of KPI, target
and follow-up to employees needs to
be improved.

5 206 - Training Minor In general the site has established a

strong training program and training
need analysis by jobs. However, the
audit observed:
• In the induction training for new
employees HSE department has to
present itself more deeply including
rules and responsibilities and phone
numbers. This is to assure that new
employees are aware about the HSE
function.
• During the investigation of the ATEX
concept of the Glatt coater training
needs with respect to of P & ID
understanding was observed.
• Training documents (AED training
from 2013) had not been signed by the
doctor

6 209 - Reporting Minor The corporate HSE has a system for

measuring performance, regularly
collected.
With respect to this it was observed:
• The targets have not been set for all
KPI
• During safety meeting, some action
plan have been postponed several
times, w/o reason (ex.: from 08/2014,
still the same action plan)
7 212 - Process Minor Globally the procedure is in place. The
transfer, scale-up site is doing a RA and addressing the
gaps and the form are used.
Observation :
• The procedure is in place, but
originator didn’t provide HSE
information to the site (HSE BH could
help)
• HSE business doesn’t approve the
transfer
• Verification must be done for some
product and improve the database :
o “Colchicine Opocalcium” which is
registered as CMR but not in the
document
o “Fluoxetin “ which is EHB5, it’s not
mentioned in the document

8 301 - Process safety Minor Process safety risk assessment is

risk analysis conducted in a multidiscipline team
(e.g. Quality, Production, Facility
Management and HSE). However, the
outcome of this assessment is not a
defined action plan. KSE are not
clearly identified during this process
(e.g. in a list).

Self-ignition temperatures of handled

powder mixtures are unknown

9 302 - Key safety Optimization Building KSE’s are under current

elements (KSE) review. They cover smoke detectors,
hydrants, manual alarm buttons, water
discharge valves, gas valves and
electrical main switches of the
buildings.
However, the reviewed plans do not
have a revision number or a date, yet.
10 304 - Electrical and Minor The site has developed a sound
non-electrical understanding of ATEX with respect to
explosion protection solvents and dusts, however
• ATEX zoning is not yet finished
completely for powder handling
operations.
• In solvent storage drums have to be
connected to the grounding system by
using clamps. However it is not
assured that the clamps do touch
metal. It was observed that the clamps
are touching only painted material and
not metal.

11 306 - Fire risk Major The site has to improve its fire risk
management management. The audit observed:
• The site could not present a layout
with fire ratings of walls/sections for
the production area. An expert report
out of 2009 is available, but changes
have not been tracked nor
documented. The identification of
relevant walls in the field was difficult.
The fire segregation of the site is not
active due to doors without fire rating
in fire walls and fire doors without
closing mechanism left or fixed open.
• Several fire doors in the
administrative building have been
found open. They do not have a
closing mechanism, nor do people
close the doors appropriately.
• A lot of empty wooden pallets in
finish good warehouse and in the
outside are increasing the fire load.
• In the Quality archive for batch files
there is no active firefighting system
only smoke detectors are present.
12 307 - Pressure Minor In the handling of systems under
vessels/Pipelines pressure the audit observed the
following:
• The “Glatt” coater operates without
overpressure. However, it is not
possible to identify it with an ID
number on the P & ID, P+I-Diagram
GPCG 300. In addition, the P & ID
does not give pressure ratings for
vessels nor for safety valves or for the
Ex-Plates. The Ex-Plates at the Glatt
coater are not mentioned in the P &
ID, P+I-Diagram GPCG 300, at all.
• Gas cylinders are stored in a specific
metal cabinet. However, not all of them
were chained to avoid the risk of fall.

13 308 - Fragile devices Minor Flexible hoses with metal wire are
obviously not grounded appropriately
as seen in different rooms (e.g. RD,
RB, R54, R54a) and validated in
cleaning room R72 at an example of
the Kilian.
14 310 - Building Minor With respect to building design it was
structural design observed:
• After removing of the HVAC systems
out of the Pellet Coating area the
situation has improved in the technical
area of that building;
However the gangway is still very
narrow. Taking into consideration the
length of the gangway and the
obstacles in the way, evacuation in
time or the rescue of an injured person
will be very difficult and time
consuming.
• No orientation light inside of the cold
storage room
• Layout of doors in main corridor can
lead to collisions, no precautions in
place.
• In the boiler house a small lab
without any ventilation was observed
• Solvent warehouse: hole in the wall
hidden by sheet of paper
• Buildings in poor condition from the
outside
• At several locations (Barbart &
corridor 1. Floor administrative
building) windows can be opened,
resulting in a very low barrier of
approximately 40 cm. G405-3
minimum barrier height
• On 1st floor some windows are
locked, whereas adjunct ones are
unlocked. Both give access to the
same roof.

15 401 - Workplace risk Optimization Risks coming from fall from height at
assessment windows needs to be more taken into
consideration.
Locations were identified e.g. (Barbart
& corridor 1. Floor administrative
building) where the minimum barrier
height needs to be reviewed. (see also
310)
16 403 - Hazrd Minor Hazard communication and labeling
communication and needs to be improved in some cases.
signage It was observed:
• In the QC lab a big LEV (exhaust
system) is installed as common safety
protective equipment and it is used by
several employees at the same time.
However, there is no information given
to employees if the equipment is
working properly. No indication of flow
or break down is in place. Tests on this
equipment could not be verified as no
test documentation is available.
• Technical instrumentations (e.g.
valves) are not labeled with the
corresponding ID of the PID in several
locations (e.g. distribution area
between liquid & solid building). In
other locations labelling is fine (e.g.
sprinkler pump house)
• No labeling “Hazardous Waste” on
the dust collector.
17 404 - Qualification Major A maintenance program is in place but
and preventive it needs to be enforced.
maintenance • Maintenance of fire doors
incomplete.
The inspection is scheduled on a
weekly basis, calculated 5 minutes per
door.
Doors do not have an individual ID and
the log file has only one checkbox for
all access doors of all levels of the
administrative building. The log file of
CW 09/2015 stated no observation.
The log file of CW 18+19 / 2015 were
signed, but no result given.
• Maintenance of grounding is
conducted annually for 260 different
pieces covering all production
departments. 3 electricians checked all
equipment within 3 days without any
finding at all. The testing form does not
expect actions to be addressed. The
content and the quality of these
checks needs to be critically reviewed
to assure all grounding equipment are
in good condition. Results are laid
down in written in an updated
document
• Safety valves are inspected
frequently, only if the release pressure
is above 6 bars (due to Romanian
legislation). The site needs to verify,
that lower pressure cannot have
negative impact on connected
systems.
• No individual ID number on flexible
hoses. No test documentation of
appropriate grounding of these flexible
18 406 - Asphyxiation, Minor Technical solution to warn employees
nitrogen and other about asphyxiation risk is not unique
gases on site. Some areas do have a
warning light outside including an
alarm, some others only inside. It has
to be assured that an asphyxiation
alarm is visible and hearable from the
in- and the outside
19 407 - Physical risks Major With respect to physical risks it was
observed:
• In packaging a machine cover is
normally fixed with screws. It was
observed that some of the screws
were removed to create an opening
which was close to rotating parts of the
packaging line.
• Access to technical areas unlocked.
These areas have to be treated as
restricted access and have to be
closed.
• Missing protection on sharp spikes at
a wall in room R 54
• Unfixed electrical outlet at a
packaging line in poor condition
• In boiler house a key to open
electrical boxes was seen on an
electrical box
• In the cold storage the panic bar did
not work properly
• Missing protection at the crusher
(which is in poor condition) of papers.
• Storage of Materials on the
pedestrian pathway.

In the QC lab the site has installed a

big LEV. The site has to verify again
the functionality of this equipment with
respect to air change and worst case
scenario (all windows open). This is to
avoid that employees have to wear
additional mask while working on this
equipment.

20 411 - Warehouse and Optimization In the lab storage practices needs to

storage be improved
• RoomB005D storage of corrosives
and absorbents stored together
• Room B005c solvent storage without
secondary retention

Labels for products are not always

stored under secure conditions in the
warehouse
Some forklifts are in poor condition. No
seatbelt, nor a safety cage, worn tires.
21 501 - Occupational Optimization The Risk Map of the Risk Assessment
hygiene exposure shows the classification before the
assessment implementation of control measures
instead of afterwards
Exposure measurements for the
substance phenobarbital (OEB3) have
been performed for the granulation
handling but not for the handling in the
weighing area.

22 502 - Occupational Minor The occupational hygiene risk

exposure control assessment is performed. A program is
in place to enhance technical
measures which have been partially
implemented. However, there are still
some areas in which PPE is primary
the main protection.
Improving of engineering equipment
against powder exposure was already
mentioned in the HSE audit report
2012.

Several offices in packaging with

textile covers on chairs were observed
with the risk on cross contamination.

23 503 - Hazard Minor The site needs to verify if substances

indentification, in the lab should be labelled with GHS
communication and pictograms.
labelling The labeling of mixtures was already
mentioned in the HSE audit report
2012.

24 504 - Workplace Optimization A contractor was observed drinking

hygiene water inside of the QC Lab.
25 505 - Occupational Major Inconsistency in using of PPE was
hygiene Personal observed at several locations
Protective Equipment
(PPE) In the QC lab
• It was explained that the yellow line
on the floor marks the area to where
wear goggles. Some employees wear
them, some not. The site has to
enforce its policy. The explanation that
googles have to be only used if
substances are handled is not
acceptable.
Further should be checked if
workplaces directly next to HPLCs
should be used without goggles.
• An employee was observed during
the working process “Identification of
Lactose”. The employee was wearing
goggles and a FFP1 mask. Two
contractors working 1m behind the
employee didn’t wear any PPE. The
concept when PPE is necessary has
to be reviewed and enforced (with
respect to HSE and Quality).
• Employees were observed with and
without gloves at common keyboards
and during paperwork. A procedure to
avoid cross contaminations is missing.
• In QC masks and glasses were
observed inside of the fume hood.
• In the Microbiology Lab no gloves for
the -40°C freezer are available. In the
related procedure the use of gloves is
missing.

In production
• The site has the procedure to wear
26 511 - Occupational Minor Noise measurements are performed.
noise control The equivalent level A weighted (Leq
A) is given in the reports, the
information about the C weighted peak
sound pressure (ppeak,c) is missing in
most of the cases.
27 604 - First aid and Minor In the main building, corridor 1st floor,
emergency medical is an first aid kit with several contents
assistance which are expired since October 2014.
Some materials are in not a good
condition or damaged. A monthly
check of the first aid kit has been
conducted since the year 2013.
In the administrative building, corridor
2nd floor is a first aid kit which content
was not in line with the list. Four
gloves were missing.
That the contents of the first aid kits
are not in line with the list was already
mentioned in the HSE audit report
2012.

28 701 - Environmental Optimization Environmental risk assessment:

risk assessment • The follow-up and progress of
priorities are not enough formalize, in
order to be reviewed during key
meeting and to prepare also the
PASS.
• The list of KEE (Key environmental
element) is missing for management of
environmental risk
• In the letter of cadrage: it’s
mentioned Top ten API’s, mass
balance evaluation, it’s part of PASS,
but the list of top ten is not formalize
(in progress).
• Risk assessment related to PIE for
labs discharge and production is
missing

29 703 - Performance Optimization • Environmental KPI exists, but target

monitoring for some are missing (E.g. : waste
amount, water consumption in
absolute value, CO2 related to main
objectives of the Group)
• In green tool, it’s mentioned WWTP
on site, which is not the case. It’s only
a filter for few amount of wastewater
released by labs.
• Environmental KPI’s (results &
progress) are not communicated to
employees
30 704 - Spill and release Minor • The pump for effluent transfer to fire
prevention containment is undersized, and a
spare pump (dedicated, maintained
and verified) should be available.
• Spill kit room 115 material gate
without PEE’s for dusts
• Room R 62t spill kit without glasses
and masks.

31 705 - Waste Optimization KPI should be considered w/ a

management reduction program. Not only cost per
box
32 706 - Waste water Minor Water management and water effluent
effluent management management
Treatment specific is not defined for
EHB5/Horm/CMR products (Labs and
prod)
Clarify the calculation/estimation
related to rain water which is given by
VEOLIA

33 709 - Climate change, Optimization Create the plan for reducing CO2 and
natural resources, objectives/targets Short term and long
biodiversity term
 In progress
HSE Audit - Corrective Action Plans : Half-yearly follow u
Closed
Generate Import File

PREVIOUS
EXPECTED
ACTION PLAN DESCRIPTION PROGRESS RESPONSIBLE
COMPLETION DATE
RATE
1. Share LEX regarding the usage of 0 20.08.2015 1. Production Manager
staircases (from one department to others) 2. HSE Manager
2. Reinforce the "keep the handrail" rule
and increase awarness
20.08.2015

Update the risk map by taking into 0 30.10.2015 HSE Manager, 30.10.2015
consideration the corrective actions in
place and also earth quake risk

Define a long term PASS and Include the 0 15.11.2015 HSE Manager, 15.11.2015
long term actions for water, CO2, API
Management
Complete the dashboard communicated in 0 31.07.2015 HSE Manager, 31.07.2015
each area by introducing also indicators
related to the water & CO2 objectives &
KPI

1.Upgrade the presentation of HSE 0 30.08.2015 1. HSE Manager, 30.07.2015

department 2. Maintenance Manager,
2. Implement training on P&ID for the 30.08.2015
technical team 3. 1. HSE Manager,
3. Training documents - to be completed 30.07.2015
with the declaration of people & doctor
related to the training developed

1. Set target for all monitored KPI 0 06.07.2015 HSE Manager

2. Increase the level of documenting the 1. 30.06.2015
status in order to have the entire picture of 2. 06.07.2015
the progress - Statu details column to be
introduced in the minute
Check the information and send 0 15.03.2016 HSE Manager 15.03.2016
documents for formal approval.

1. Update data base regarding EX 0 15.02.2016 Facilities Manager,

parameters of product with data from 1.30.08.2015
Sanofi site &Institute for Occupational 2. 15.02.2016
Safety and Health of the German Social
Accident Insurance
2. Develop characterisation of 10 API with
external laboratory

Approve and present in an formalised way 0 20.11.2015 Facilities Manager,

the plan building containing KSE's 20.11.2015
1. risk analyze for powder will be made 0 15.02.2016 1. Facilities Manager,
after finalized the analyze of 10 products 15.02.2016
2. Communication done to the operators 2. Warehouse Manager,
from Warehouse 05.05.2015

1. Complete layout with fire ratings 0 15.02.2016 1. HSE Manager, 15.02.2016

2. Reenforce the rule of keep doors closed 2. HSE Manager, 08.06.2015
3. Move the wooden pallets to the required 3. Warehouses Manager,
distance; define a place to strore the 31.06.2016
pallets in proper & safe conditions 4. Facilities Manager.
4. Define technical solution - to close all 30.08.2015
the electrical sources in Quality archive
1. Complete the diagrammes with the data 0 31.12.2015 1. Maintenance manager,
from Glatt 31.12.2015
2. Communicate on the risk of fall 2. Quality manager,
19.06.2015

Ground the flexible hoses 0 20.05.2015 Maintenance Manager,

20.05.2016
1. Continuing Technical attic Plan 0 25.11.2015 2. Warehouse Manager,
according LRP 05.05.2015
2. Install orientation light inside the cold 3. Production Manager,
room 30.11.2015
3. Install phisical barieres in front of the 4. Facilities Manager,
doors which can lead collision 30.08.2015
4. Install ventilation in the lab in Boiler 5. Warehouse Manager,
House 12.05.2015
5. fix the hole in the warehouse 7. Facility manager,
6. Improve outside conditions of the 30.06.2017
buildings according to plan 8. Facility manager,
7. Identify the windows & imcrease 25.11.2015
phisical barier
8. Install phisical barrier to restrict the
access to the roof.

Assess and implement phisical barieres 0 30.09.2016 Site Maintenance

Coordinator, 30.09.2016
1. Set-up of vizual indicator if LEV is 0 30.03.2016 1. Quality Manager,
functioning 30.08.2015
2. Label of valves according with P&ID 2. Maintenance Manager,
3. Label the dust colectors 30.03.2016
3. Facility Manager,
30.06.2015
1. Label the fire doors & mark on the site 0 30.03.2016 1. HSE Manager, 30.08.2015
layout. Reinforce the check of the doors 2. Facility Manager,
2. Review the form for grounding tests to 30.07.2015
include actions done & planned 3. Facility manager,
3. Include the safety valves on preventive 30.03.2016
maintenance plan 4. Production Manager,
4. Alocate ID for each flexible hose 30.09.2015
5. Extend the IR checks 5. Techniocal Manager -
6. Periodically check CAPA Plan from 25.06.2015
Maintenance 6. Maintenance Manegr,
30.07.2015

Align thecnical solutions to warn 0 20.03.2016 Facilities Manager,

employees about anoxia risk. 20.03.2016
1. Fix all the mentioned points & develop 0 30.09.2015 1. Production, Maintenance
CAPA in order to avoid occurancy & Waregouses Managers,
2. Validate LEV 30.08.2015
2. Q Manager, 30.09.2015

1. Improve the storage knowledge & 0 30.09.2015 1. Q Manger, 30.06.2015

conditions 2. Warehouse Manager,
2. Fix the doors of the area where labels 30.06.2015
are stored 3. Warehouse Manager,
3. Upgrade the condition of forklifts 30.09.2015
Complete the quantitative assessment for 0 30.09.2016 Production & HSE
all API OEB 3-5 in all dispensing & Managers, 30.09.2016
production stages

1. Continuing the Colective Protective 0 30.06.2016 1. Production Manager,

strategy in Solids 30.06.2016
2. Define Cross Contamination Policy & 2. HSE Manager
rules in terms of HSE 20.08.2015

Insert the pictogramme on the usual label 0 30.08.2015 Q Manager, 30.08.2015

of the reagents stored at the workingplace
for more than 1 week

exclude drinking water from the QC lab 0 30.07.2015 Q Manager, 30.07.2015

area
Safety Day by Day Programm: Review 0 10.03.2016 Production & QC Managers -
PPE policy, reinforce the rules, increase end of the program
awarness, increase HSE knowledge & 10.03.2016
competency

Perform noise measurement including 0 30.07.2015 HSE Manager, 30.07.2015

also C peak sound
All the first aid box will be mouved in 0 30.07.2015 HSE Manager, 30.07.2015
controlled areas (in some offices)

1. Report PASS progress in formalised 0 30.06.2016 HSE Manager

way - semestrial written report 1. starting with 30.06.2015
2. Define KEE 2. 30.12.2015
3. Prepare risk assessment for PIE (top 3. 30.06.2016
10)

1. Define targets & increase number in line 0 20.08.2015 HSE Manager,

with Group objectives for Environmental 1. 30.06.2015
KPI's 2. 31.07.2015
2. Exclude WWTP from GREEN report 20.08.2015
3. Communicate more visual all above
mentioned KPIs
1. Acquisition of a new and adequate 0 30.08.2015 Facilities Manager,
pump 30.08.2015

Upgrade the dasboard with the new 0 30.06.2015 HSE Manager, 30.06.2015
mentioned KPI's

1. Define specific treatment for specific 0 30.08.2016 1. HSE manager, 30.08.2016

types of water & substances 2. HSE Manager, 30.09.2015
2. Clarify the calculation of the amount of
rain water

Create a plan for CO2 management 0 15.11.2015 Facilities Manager,

15.11.2015
: Half-yearly follow up

HISTORICAL REVIEW
 PERFORMED ACTION DURING LAST 6 MONTH
IF MODIFICATION OF RESPONSIBLE OR EXPECTED COMPLETION DATE, PLEASE MENTION IT

LEX regarding usage of handrail performed; inventory of missing handrails reviewed and
staircases fixed;
"keep the handrail" awarness continued with better procentage of usage - lon term process

risk map upgraded as required

3 years basis PASS defined. Formal approval will follow in first management meeting in January
dashboard completed; communication done more focused also during ISO 50001 implementation

Presentation upgraded and in use to train new commers and contractors

Training completed on P&ID for the technical team
Training documents completed in order to prove the delivery of the first aid training

all targets are documented in site dashboard;

new way of warking implemented in terms of HSE CAPA, in order to keep the traceability of the
actions. More details are listed.
all the documments are listed to be formally approved.

Information are upgraded; contract for testing API is formalised; first substances are selected.
We will perform tests only for 2 substances due to the new data that we have and according to the
risk assessments performed.

KSE's plan formalised

ATEX zoning - under assessment;
communication related to the grounding procedure done

complete the layout is under completion;

rule of keeping the dors closed in clearly marked on the doors
wooden palled are at required distance;
technical solution for Quality archive is already impleented: all electrical sources are closed
immediately in case of emergency;
diagrammes are completed
risk of fall due to innapropriate storage of gas cilinders was communicated.

action under completion

2.orientation light inside cold room - implemented
3.precautions installed to avoid collisions
4.new ventilator in the Boiller House
5.hole fixed in the warehouse
7.identification completed; solution identified
8. phisical barier is restricting the acces to the roof
LEV functioning is visible now;
valves are labeled;
dust collector is labeled
1. fire doors are marked & tested
2. form for grouding tests was reviewed and responsibles trained
3. started the action of include safety valves in mainenance plans
4. ID in place
5. last IR check eas extend to critical equipments in production
6. CAPA checked
All items fixed
LEV functioning tested by specific procedures; approved to be used.

storage improved; communications performed on topic

doors in warehouse are fixed
forlifts were upgraded
quantitative assessments are on-going

Strategy on CPE is continuing

Cross contamination Policy defined

label are upgraded with specific pictograms

drinking water excluded

actions on-going, according to the program

C peak sound included in all proocols & tests

first aid boxes moved in offices, in location undre control.

PASS progress formalised

KEE define in a list & maintenance program cheked
PiE risk assesment started - planning phase

KPI defined and targets settled

WWTP excluded from report
visual communication done, especialy during ISO 50001 implementation
spare part - pump is availlable

dashboard completed

assessment ongoing for the water treatment

calculation rate clear for the site

CO2 reduction plan created

NEW PROGRESS
RATE

100

100

100
100

100

100
30

80

100
75

80
100

40
80
100
90
100

100
40

50

100

100
75

100
100

70

100
100

100

50

100
Priority Rec. # Description Type

Implementation in progress

Investissement Important
Flag

En cours de réalisation

Date de Réalisation
Date of Completion
Significant CAPEX
Study in progress
En Cours d'Etude

Commentaires
Non Planifié
Completed

Comments
Désaccord
Disagree
No Plan
Réalisé
Comments from
FTC 2015 - 01 - 28

Site response
Implementation in progress
electrical station finalised; to be connected.
The project it is achieved Q2 2015
2 10-02-009 Replace the old electrical equipment. Equipment and in 90%. Now the project is
Support Systems x
frozen due to legal issues FTC response
in relation to our national Awaiting neighbors authorization
dealer.

Site response
Study in progress
Q3 2015
Planned for 2017 due to
2 11-02-003 Relocate the ignitable liquid stored Occupancy Hazards new changes of the FTC response
within the raw material storage. x
needed capacity for Awaiting study
solvents

Site response
Implementation in progress
Q3 2015
Database containing dust
parameters was updated FTC response
Improve dust handling and explosion for 9 more products.
protection in various areas of the SDF Dust characteristics determination is ongoing by a Romanian
2 10-02-007B production plant." "Provide dust Equipment and company
Support Systems x
explosion parameters of handled raw Dust parameters will be
material. tested for 2 intermediary
products till the end of Q2
2016

Site response
Provide adequate sprinkler protection Significant CAPEX
fed from an adequate and reliable water during refurbisment, after the pump life cycle
3 10-02-011D supply." "Provide an adequate and Water Supplies x
reliable water supply for automatic
sprinkler protection. FTC response
OK
Site response
Significant CAPEX
Provide adequate sprinkler protection
fed from an adequate and reliable water Automatic Protection during refurbisment
3 10-02-011B x
supply." "Reinforce the existing sprinkler and Detection
system in the raw material storage. FTC response
OK

383910508.xlsx
 Site response
Significant CAPEX
Provide adequate sprinkler protection
fed from an adequate and reliable water Automatic Protection during refurbisment
3 10-02-011A x
supply." "Provide automatic sprinkler and Detection
protection throughout this facility. FTC response
OK
Site response
Provide adequate sprinkler protection Significant CAPEX
fed from an adequate and reliable water during refurbisment
3 10-02-011C Automatic Protection
supply." "Reinforce the existing sprinkler x
system in the packaging material and Detection
storage. FTC response
OK
Site response
Significant CAPEX
Provide earthquake protection for the during refurbisment
3 10-02-017 Natural Hazards x
automatic sprinkler systems.
FTC response
OK

383910508.xlsx