Table 1
Term / Abbreviation |
Definition |
API |
Active Pharmaceutical Ingredient |
ATEX |
Atmosphere Explosible (French acronym) |
CAT |
Category |
CCTV |
Closed-Circuit Television |
cGMP |
Current Good Manufacturing Practice |
CMMS |
Computerised Maintenance Management System |
CSE |
Confined Space Entry |
CTU |
Central Test Unit |
Ex |
Explosion protection symbol displayed on equipment that is suitable for use in an ATEX area |
FT |
Facilities Technicians |
HR |
Human Resources |
HSA |
Health And Safety Authority |
HSE |
Health, Safety and Environment |
IR |
Industrial Relations |
IS |
Irish Standard |
IFM |
Integrated Facilities Management |
KPI |
Key Performance Indicator |
LEL |
Lower Explosive Limit |
LVI |
Liquid Vapour Incinerator |
NIPBI |
Novartis International Pharmaceutical Branch Ireland |
NRL |
Novartis Ringaskiddy Limited |
MCB |
Miniature Circuit Breaker |
MEWP |
Mobile Elevated Work Platform |
MTBF |
Mean Time Between Failure |
MTTR |
Mean Time To Repair |
PB1 |
Production Building 1 |
PB1A |
Production Building 1 Annex |
PB2 |
Production Building 2 |
PM |
Preventive Maintenance |
PU |
Production Unit |
QA |
Quality Assurance |
SAP |
Computerised Maintenance Management System used by Novartis |
SOP |
Standard Operating Procedure |
TS |
Technical Services |
VEIS |
Veolia Environnement Industries Services |
One could be forgiven for thinking that compiling a maintenance strategy for an emergency lighting system would be a trivial matter to execute.
This may possibly be the case with a small office building but our challenge at Novartis was not a task that could be underestimated.
The first thing to consider is the scale of the site at approximately 150 acres and that emergency lighting by its nature permeates every nook and cranny. The second is the huge emphasis placed on safety which is understandable when Seveso directives are factored in.
Adding to this was the fact that until VEIS arrived on site there was no existing strategy for the maintenance of the emergency lighting system. Once the remit passed to VEIS, literally overnight, we inherited the mammoth task of restoring the system to full operation and ensuring regulatory compliance in terms of inspection and testing.
This all was being played out under the watchful gaze of existing site staff that may not have been openly welcome to the notion of an IFM company’s arrival on site.
There was minimum time for VEIS staff to ease into their roles in this challenging environment. Needless to say the first six months on site were a baptism of fire (but thankfully not in the literal sense!).
Besides immediately assuming inspection and testing duties, the initial stages involved gathering data on both the quantities of light fittings present and the extent of repair work required. The next stage required meeting with suppliers to arrange for parts supply. Full restoration of the system would then take place in tandem with ongoing inspection and testing.
Regarding inspection and testing, there was little leeway for VEIS to create a customised approach as the regulations in I.S. 3217 2013 are quite prescriptive. We simply had to figure out the most effective and efficient way to deliver the required performance of such a safety critical system.
I believe the expertise required from VEIS was not to reinvent a method of maintaining an emergency lighting system. Instead it was to implement a strategy, where none existed before, that worked both in terms of compliance to regulations and ensuring maximum availability of a safety critical system. On this front, we certainly delivered.
Novartis Ringaskiddy Limited is an API manufacturing plant located in Co. Cork Ireland.
It is part of the Novartis global healthcare company which is based in Switzerland.
In January 2014, VEIS assumed responsibility for the provision of an Integrated Facilities Management contract of 5 years duration. This encompassed the following equipment/services:
This was the first venture into the outsourcing of Facilities Management services by Novartis so there was a steep learning curve for all concerned.
My role with VEIS was Technical Team Lead with primary responsibility over Utilities and Hard Services.
Our most immediate Task was to implement a Maintenance Strategy for site wide Emergency Lighting. This had fallen into neglect over the years; mainly due to a lack of a dedicated team to oversee its maintenance – there had almost been an ad hoc approach to testing and repair.
Besides my role as Team Lead, the VEIS maintenance crew consisted of 2 Facilities Technicians, both with strong past electrical experience.
It was decided that upkeep of the Emergency Lighting system would be fully self-delivered with no outside contractor involvement.
Figure 1: Novartis Ringaskiddy Limited (Source: PM Group)
Figure 1 is an aerial view of the Novartis Ringaskiddy Limited site (PM Group).
Table 2
A |
Main Switch Room |
B |
Pump House |
C |
Tank Farm |
D |
Solvent Recovery |
E |
LVI |
F |
Contractor’s Compound (not in IFM contract scope) |
G |
Project Stores (not in IFM contract scope) |
H |
PB 2 |
I |
PB 1 |
J |
PB 1A |
K |
Waste Water |
L |
Utilities |
M |
Technical Services |
N |
QA Labs |
O |
Warehouse |
P |
Canteen/HR/Administration |
Q |
NIPBI Labs |
R |
Security Gate House |
Table 2 defines alphabetically labelled points in Figure 1.
Novartis Ringaskiddy Limited is subject to Seveso directives. These directives are put in place to help prevent major industrial accidents and ensure that sites are prepared, in terms of response, for when accidents occur (European Commission, 2016).
Sites are categorised according to the amount of hazardous chemicals in storage (Lawlor Technology, 2015). NRL is an upper tier Seveso site – there are up to 4000m3 of solvent chemicals stored on site.
There are also several Zone 1 and 2 ATEX areas. The HSA (n.d.) defines these as:
“Zone 1 – That part of a hazardous area in which a flammable atmosphere is likely to occur in normal operation.”
“Zone 2 – That part of a hazardous area in which a flammable atmosphere is not likely to occur in normal operation and, if it occurs, will exist for a short period.”
Another example of a hazardous area is the Dryer Unloading area in PB1. During certain production campaigns, there is the presence of Category 3 chemicals here. Access to the area is strictly prohibited during these times. Contact with minute amounts of Category 3 chemicals can have severe health consequences for a person (Ader et al, 2005).
Because of the highly dangerous operating context of the emergency lighting system, safe work practices were essential for the VEIS team on the Novartis site.
We were required to develop a method statement for emergency lighting maintenance activities. This was reviewed by the HSE department and a site electrical engineer. Edits were performed where necessary prior to final approval.
The use or carrying of cellular phones was prohibited at all times at NRL.
It’s worth noting for this exercise the challenging IR environment that VEIS entered at the beginning of the IFM contract. It was seen by many on site that moving to an outsourced service provider would result in lay-offs for NRL maintenance staff.
In reality VEIS were tasked at delivering in areas that were either previously neglected or lacked central control.
Until this realisation had sunk in, maximum discretion and diplomacy was required from the VEIS team in order to gain acceptance from the existing site staff.
During the initial stages of the VEIS team’s arrival onsite, there was an unwavering focus on all aspects of our conduct. It was of prime importance that the team displayed the upmost professionalism and adherence to safe working practices at all times.
It was essential that, for our maintenance strategy to work, full cooperation was received from existing site staff. This involved gaining trust from both management and ‘floor’ staff.
The Novartis Ringaskiddy site, under the surface, functions as a group of almost autonomous areas. The production buildings, utilities, warehouse, tank farm & waste water areas all have designated management teams who all have in turn subtle but distinct differences in methods of operation.
As emergency lighting is a utility that features across the site, the VEIS team had to find a way to adapt to the varying cultural practices in order to make our strategy work.
Engaging in a respectful and sometimes almost deferential manner was the order of the day. Here are some of the bridges that had to be crossed:
Method Statement development
Planning Meetings
Client Meetings
KPI Score Card
Client interaction was critical here. See section 13.0 for specific detail.
ATEX areas
It was vital for VEIS to gain the confidence of the client in our ability to work safely and competently in the ATEX areas. As an embedded contractor, we were subject to more intense scrutiny than any sub-contractor that provided services to the client. An example would be the purchase of a Fluke Ex multi-meter that we made. This came at a cost of €1000. All other electrical maintenance staff used the non-Ex €300 version.
Asset Register
Individual emergency light fittings were not listed on the NRL asset register. The lowest level the register went to was the Central Test Units. The Novartis engineers were keen to have a full schedule of emergency light fittings included in the asset register so it made sense for VEIS to assist them. Aiding the NRL engineers with this task was not in the scope of the IFM contract but providing this service did much to solidify the relationship and further build trust. This was practically a mini project and involved the following activities:
Site Manual (Play Book)
A site manual or ‘play book’ was developed which outlined the scope of the VEIS IFM contract. This was a live document which evolved as the contract progressed and reflected any new services that were added to the remit of VEIS. The site manual was subject to periodic review by the Novartis IFM lead. High level maintenance strategies were also stored in in this book.
In order to comply with rigorous onsite HSE policies, VEIS technical staff required training/certification with the following:
As previously mentioned, the Emergency Lighting system had fallen into a state of disrepair on the Ringaskiddy site. With the arrival of VEIS onsite as the IFM provider, a new impetus was put on restoring the system to full operating order and maintaining it to a proper and compliant standard.
In addition, it was quickly noticed by the VEIS team that list of emergency light fittings in the contract tender was not correct. There had been several additions and modifications to the system without proper records to reflect the changes.
After a thorough appraisal, it was found that more than €100,000 would be required in parts purchasing to carry out the necessary repairs. This would have to be actioned by VEIS as it was within scope of the contract.
Appendix B lists the costs of parts required to achieve a fully functioning emergency lighting system.
All of the emergency light fittings on the NRL site are of the Self-Contained Emergency Luminaire variant.
This type is defined as having all components such as the lamp, control unit and battery either inside or not more than one metre from the fitting (Ventilux, n.d.).
Figures 2 and 3 show both the most commonly used and most expensive to replace fittings used at NRL.
There are other types also such as ‘Exit/Running Man’ and ‘Twin Spot’. Although these are equally critical from a safety perspective, they came at a fraction of the cost to replace.
It was decided because of the preferential pricing available for purchasing complete Stahl fittings that these would be used to replace defective CEAG units that were economically unrepairable.
CEAG fittings were kept in service only when the repairs didn’t extend beyond tube and battery replacement.
Figure 2: Stahl Ex Emergency Light Fitting (Source: Stahl)
Figure 2 shows the types of Stahl light fittings used on the Novartis site (Stahl).
Figure 3: CEAG Ex Emergency Light Fitting (Source: Atex)
Figure 3 shows the type of CEAG light fitting used on the Novartis site (Atex).
Table 3
Fitting Type |
|||
Ex Zone 1 |
Ex Zone 2 |
Safe Area |
|
Main Switch Room |
6 |
||
Pump House |
15 |
||
Tank Farm |
28 |
57 |
28 |
Solvent Recovery |
33 |
69 |
|
LVI |
16 |
35 |
|
PB 2 |
563 |
130 |
|
PB 1 |
530 |
145 |
|
PB 1A |
285 |
78 |
|
Waste Water |
58 |
31 |
|
Utilities |
55 |
||
Technical Services |
95 |
||
QA Labs |
88 |
||
Warehouse |
93 |
||
Canteen/HR/Administration |
125 |
||
NIPBI Labs |
168 |
||
Security Gate House |
7 |
||
Sub Totals |
1455 |
219 |
1064 |
Grand Total |
2738 |
Table 3 list the corrected amounts of light fittings by zone and by area.
The more correct way to classify equipment suitable for use in Ex Zone 1 and Zone 2 areas is by CAT 2 and CAT 3 respectively. However it is normal in Industry to reference them by Ex Zone numbers only.
Safe Area refers to type of light fittings used outside of the hazardous areas.
The one benefit of taking on a dilapidated system, from a maintenance perspective, is that you have the data to hand on the reasons why the assets have failed. Figure 4 displays a breakdown of these failure modes for the emergency light fittings on the Novartis site.
This information was a key driver in deciding the amounts and types of spare parts to be held on site.
Figure 4: Reasons for Light Fitting Failure
Figure 4 illustrates failure data compiled on the NRL site.
The Inspection and Maintenance activities evolved as the contract progressed on the Novartis site. The initial stages comprised of inspection and data gathering. This advanced to inspection, testing and repairs.
Novartis utilises the SAP CMMS to administrate all of its maintenance activities. VEIS staff were trained onsite in the use of this system. The Facilities Technicians were trained to
User level while the Technical Team Lead was trained to Planner level.
As effective owners of the assets and systems that were in scope for the IFM contract, it was agreed that we would manage maintenance activities end-to-end.
Here is a synopsis of how we ran this aspect of our operation for the emergency lighting system:
See Appendix C for definitions of the terms used by the SAP CMMS.
See Appendix D for an example of a Novartis Work Order raised on the SAP CMMS.
There was variance across the NRL site in how permits to work were processed. Again it was an example of how at a high level there was standard practice but the reality on the ground was different.
This was another area where VEIS had to adapt to the different procedures and ensure both safety compliance and a timely manner for delivering works. The time concern stems from lengthy delays that could occur if one did not follow the specific permitting guidelines for a particular area.
See Appendix F for a table displaying the differences per area in processing of permits to work on the NRL site.
Daily Test
The following is the procedure employed for the daily test:
Visual Inspection of Emergency Lights
Under the previous I.S. 3217 standard, all emergency light fittings had to be visually inspected weekly. This would have been near impossible for the VEIS team to deliver.
The current standard stipulates that 25% of fittings are to be visually inspected weekly resulting in 100% being checked in a four week period.
The following is the procedure employed for the visual inspection:
Three Monthly Inspection (for a 3 hour self-contained system)
The following is the procedure employed for a 3 monthly inspection:
Annual Load Test (for a 3 hour self-contained system)
The following is the procedure employed for the annual load test:
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