Crucell corporate brochure (PDF)

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Crucell’s commitment to the world – Taking responsibility
Safety improvement: a case study
In January 2011, a Crucell technician had a serious accident while
handling glassware in one of our production facilities. The worker
was pushing a tray of bottles sprayed with antiseptic under the
laminar flow hood (air-control barrier) of a sterile handling unit.
The bottles toppled and fell, and the technician suffered a deep
cut as he tried and failed to catch them in his gloved hands.
His colleagues had received safety training and responded
appropriately, most probably saving his life.
If we examine the risk factors in this situation—the wet and
slippery glassware, the laminar hood, the sterile gloves, the tray
and handling method—we see that they are all related to Good
Manufacturing Practice (GMP) in our industry. Biopharmaceutical
production must be conducted under highly sterile and controlled
conditions in order to ensure the safety of the people who receive
our products. However, this can potentially create unsafe
conditions for production workers. The challenge we face is
to safeguard both our employees and products.
Our safety and process experts meet this sort of challenge by
analyzing the precise circumstances in which accidents occur and
looking for GMP-compliant technical workarounds, or ways to
avoid unsafe process steps altogether. At the same time, they focus
on raising employees’ awareness of workplace risks and how to
respond if an accident does occur.
1 The OSHA defines the LTC as the number of accidents resulting in at least one whole
shift absence, per hours worked by 100 employees in 12 months (200,000 hours).
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One of the tasks of safety officers is to collect data on accidents,
with the aim of gaining a better understanding of risk factors and how
to manage them. In our 2009 CSR report, we published accident data
collected independently at our five manufacturing and/or development
sites (covering 90% of the workforce) but noted the limitations of these
data. For example, countries used different definitions and ways
of measuring accidents.
In 2010, we focused on taking EHS information management to the next
level by introducing a global reporting system based on harmonized
criteria. Access to more detailed information, collected from our production
and R&D facilities using the same definitions, will give us greater power
to continuously improve safety, using a ‘plan-do-check-act’ approach.
We are well on track towards this goal. A clear procedure for accident
reporting, analysis and follow-up with corrective action has been
introduced. An EHS Reporting Manual has been developed, local
safety officers have been trained in its use and full-year data based
on consistent criteria have been collected and analyzed. A reporting
infrastructure has been established and is working well: local data
are reported to the global EHS manager, who gives regular updates
to the Chief Operating Officer (safety data on a monthly basis,
other information quarterly).
Accident reporting
Agreeing on a consistent definition of reportable accidents was a
challenge. After considerable debate, we have decided to adopt the
United States’ Occupational Safety and Health Administration (OSHA)
definition of lost time case rate (LTC) 1 , excluding accidents that occur
on the way to or from work and excluding medical conditions (such
as fainting at work). Using consistent definitions allow trends to
be followed.
Analysis of the LTC among Crucell employees at our five main sites over
the period 2009–2010 (see graph) suggests that accident frequency has