I interview Dermot Dolan just before he leaves his base at the Grange Castle biotechnology facility in Dublin, Ireland, to audit environment, health and safety (EHS) performance in Pfizer plants in India for two weeks.
Sitting at the top of the biopharmaceuticals giant's global EHS data gathering and assurance function, it might seem unusual that Dolan would still have his hands on the levers of site audits. But he makes four such trips a year on average to countries such as Singapore and Algeria as well as the US, leading assessments of some of the company's 60 manufacturing plants and ten major research and development (R&D) centres.
He says he values the way the close-up scrutiny lets him sense-check his picture of the enterprise risk assessment for the whole of Pfizer and allows him to talk authoritatively about local conditions from the organisation's centre.
"I'm also resident at a manufacturing site and I keep connected there," he says. "But the audits are a great opportunity to listen and to have a dialogue and build up relationships. That's part of what I enjoy about it. The other part is the technical side; I learn something every time. My message to the team is keep yourself out in the field as much as possible. That's where you spot the vulnerabilities and opportunities."
Dermot Dolan career file
2013-present, Global EHS director, systems and audit, Pfizer
2010-2013, EHS director, Pfizer
2007-2010, EHS associate director, Wyeth Pharmaceuticals then Pfizer
2002-2007, Environmental lead, Wyeth Biotech
2001-2002, Consultant, Fehily Timoney and Company
1998-2001, Consultant, Bord na Mona Environmental
Pfizer, with an operating revenue last year of £40.3bn, is one of the world's largest pharma companies, employing almost 100,000 people worldwide and manufacturing more than 100 prescription medicines. Its non-prescription products include the painkiller Advil and cough medicine Robitussin. In recent years it has diversified into biotechnology and research and production of other medical products (see the "All change" box below)
One of Dolan's responsibilities is overseeing Pfizer's EHS management systems standards that ensure the company meets its goals for compliance and risk reduction. The systems have been aligned to the International Organisation for Standardization's standards and the BS OHSAS 18001 safety and health specification.
Nevertheless, whether or not individual manufacturing sites and R&D facilities seek certification to the external standards is up to the site management. "We've given a direction: 'If it makes sense to you locally, then do it'," Dolan says.
When he conducts local audits he says he is prepared to counsel the managers if he sees the effort put into certifying systems is not benefiting the site.
Pfizer has followed the development of ISO 45001, the replacement for BS OHSAS 18001 due to be launched in the next six months, "and we'd expect our sites that are signed up [to 18001] will continue with that".
Overall, he says "we are still trying to work out how important it is from a business perspective". In recent years certification has become more important when competing for tenders to produce medicines for government bodies. The increased emphasis on supply chain standards management in the revised ISO 14001 issued in 2015 has also contributed to discussions about whether the company should gain certification more widely.
Pressure from non-governmental organisations has led to interest from corporate investors in social responsibility rankings and reporting schemes such as FTSE4Good and the Global Reporting Initiative. These mostly rate environmental performance. I ask whether Pfizer has seen any analogous pressure from investors to report on safety and health impacts.
The demand is not as great, he says. Sustainability and particularly carbon footprint are still the main indicators.
In the scheme of things
As global environment health and safety (EHS) director, systems and audit, Dermot Dolan's broad range of responsibilities includes oversight of Pfizer's EHS audit function and of governance related to the company's global safety standards, the management system and safety metrics programme and overseeing to evaluate EHS and business resilience risk across the enterprise.
He reports to Pfizer's vice president of global EHS. In the EHS leadership team he is responsible for co-ordinating strategies and goals and the EHS finances.
"I do a bit of everything," he says, "but the core is audit, governance and enterprise risk. I have to make sure I'm never too involved in everything, so I keep myself focused on the main components."
He is responsible for overseeing the process to review Pfizer's EHS risk management. "We have a structured review that brings all that data and information together," he says, "benchmarking performance data for the main EHS technical areas and the broader risks such as climate change, the kind of big ticket items we can only review on an enterprise-wide basis."
His reports include three audit team leaders, a training associate and two data analysts who support him in preparing reporting EHS metrics.
The EHS audit teams draw from 25 to 30 internal staff and external consultants as needed. They audit the facilities such as Pfizer's 60 manufacturing sites and 10 major research and development centres every three years.
"In areas such as our supply chain we are seeing continued interest in modern slavery, labour ethics, business resilience and the continued growth in regulations.
"We have had assessment and audit programmes in place for years in our supply chains," he adds. "Now it's about adapting those to investors' interests, among other factors."
The company has taken a lead on the industry's Pharmaceutical Supply Chain Initiative (PSCI), recently chairing the programme. The PSCI principles (bit.ly/2ztpuz1) commit manufacturers, among other things, to managing process safety and providing workers with workplace hazard information and training, to robust process safety measures and emergency procedures.
Dolan says Pfizer works closely with its suppliers, including the manufacturers of the starting materials and intermediates for its products. Recently in the EHS field it has focused and offering them expertise in occupational hygiene assessments and process safety.
Pfizer is just past halfway through a five-year EHS strategy that has four main pillars: compliance, risk management, culture and sustainability. He says the company is "pretty much on track" to meet the strategy's targets, on which the EHS team reports to a steering group of senior leaders from across Pfizer.
"Next year we will be thinking about the next generation of goals and strategies and deciding where we want to go. That will be an aspirational discussion on where we want to drive leadership and culture," he says.
Driven to improve
Pfizer's manufacturing operations have significant process safety hazards. "And the chemical and biological entities we are developing and manufacturing to supply these medicines mean exposure controls for chemical compounds and biological agents are important," says Dolan.
But those hazards are rigorously contained. In fact, the most acute risk the EHS function has to deal with is on the public highways.
"A large part of our workforce is on the road," notes Dolan. The company employs thousands of sales representatives who travel to GPs' surgeries and medical providers every day promoting its products, often under time pressures.
The risk is not concentrated just in the developing markets where the road system and regulation may not be as well established: "We had a fatality this year in the US," Dolan says.
The fleet safety programme to manage down road risk is driven by the senior management in the commercial divisions, with the support from other parts of the organisation. The procurement division ensures company vehicles are safe and supplies fleet data. The EHS function advises on and provides training resources, and monitors programme performance
Drivers are subject to individual risk assessment covering their road experience, collision history and their driving tasks. Those who need further training are given it.
Country management sets improvement targets. These resulted in a fall in the collisions per million kilometres driven from 7.35 to 7.03 in 2015 after a broadly static rate for the previous couple of years.
Among the lower severity hazards, "slips, trips and falls remain a challenge for us in terms of gross metrics," Dolan says. Pfizer has run campaigns to cut slips and trips but seasonal influences -- that cause people to slip in wet or icy environments -- continue.
One intervention launched earlier in the decade to try to contain such persistent hazards was a "situational awareness" campaign across the company. The programme promotes a continuous process of dynamic risk assessment, encouraging employees to ask: What am I doing? How can I be injured? and What can I do to prevent injury?
The emphasis is on employees taking action to mitigate the risks they identify, says Dolan, and its success is partly down to the simplicity of the message, and partly to local tailoring of the central theme. "Each situational awareness poster is bespoke to the site, for example," says Dolan, "featuring the colleagues involved in the work, be that a quality, engineering or operations colleague."
This emphasis on site-level implementation with central support to ensure it aligns with Pfizer's EHS strategy will carry over into any refresher campaign for the situational awareness messages, which Dolan says is likely.
Sound of body
"We are a health-based company so this kind of thing is easy for us," says Dolan of Pfizer's employee health management regime. The company has the health risk assessments and surveillance programmes that would be expected of any pharmaceutical research and manufacturing operation, plus employee assistance programmes in all its operating countries to support workers with stress or personal problems.
We have a structured playbook that goes from day one to day 100 with activities to start to integrate an acquisition
Musculoskeletal disorders (MSDs) are a primary cause of sickness absence in the company.
"As a science-based company we have a lot of laboratory work," he says, "so we have done a lot in the R&D settings." This includes ergonomic risk assessments, redesigning workstations and equipment such as glovebox chambers and automating highly repetitive tasks such as pipetting where small quantities of material have to be added to hundreds of samples.
"We are in the middle of a global audit of ergonomics at the moment and know we still need to put more resources into those areas," he says.
Pfizer also runs healthy lifestyle and wellbeing campaigns. As with management systems certification, many of these programmes are operating unit- or site-level initiatives, though Dolan says the central EHS function supports local management with resources and advice.
"When I go to sites I see different flavours," he says. "In Asia they will have tai chi and different break routines, and days allocated to wellness, while it would be different in the US."
He cites a programme in Pfizer's Paris office to help improve employees' sleep quality, which had particular benefits in reducing fatigue among sales representatives on the road.
The best EHS initiatives, including the wellness ones, are recognised in Pfizer's annual Safety and Sustainability Star Awards. Dolan sits on the judging panel and says the award criteria include that the programme satisfies a measured need, is evidence-based and provides a return on investment.
"Each year we get some great nuggets coming through from a wellness perspective from different locations," he says. "When people do it well we really want to promote it."
This promotion comes through publicity for the award-winning campaigns but also at technical forums for the EHS staff and webinars on best practice.
"Our whole business model has changed over the past five to ten years," says Dermot Dolan.
As its patents for hugely successful drugs, such as cholesterol-reducing statin Lipitor, have expired, with a resulting loss of lucrative manufacturing exclusivity, Pfizer has accelerated research and development in new areas of medicine such as biotechnology and gene therapy, with a particular focus on cancer prevention and treatment.
Keeping pace with the new technologies from a risk management perspective entails assessing new types of reactive chemistry and production on different scales and in new territories.
"Currently we are focused on adapting our biosafety risk assessment processes to gene therapy, says Dolan. "The technology itself involves the introduction of genetic material into the body, often through delivering a corrected copy of a gene to a patient's cells to compensate for a defective one, using a viral vector. Ensuring our risk assessment processes are robust to protect our researchers and our manufacturing colleagues working in this area means our efforts in EHS are never static."
"We are dealing with potent compounds, particularly in oncology," he adds. "For those compounds to do what they need to do in the body they have to be that potent and in the workplace there are key challenges in terms of containment and exposure controls."
In its traditional operations the company maintains 60 manufacturing sites around the world, but has added a layer of innovative flexibility by creating portable, continuous, miniature, and modular (PCMM) development and manufacturing facilities. PCMM units are self-contained manufacturing pods, about 30% the size of a conventional manufacturing plant, that can be installed, commissioned and making tablets within 12 months. "Occupational exposure risk control in these pods versus traditional fixed building and containment suites was the main EHS challenge to consider," says Dolan.
Pfizer's EHS function worked on engineering controls to contain hazardous compounds with very low occupational exposure limits.
Pfizer's changing business model (see the "All change" box) has led to multiple acquisitions. In the past four years alone it has absorbed Innopharma, Anacor Pharmaceuticals, Medivation and Hospira.
As a result, Dolan's function has a well-rehearsed system for bringing new facilities and workforces into Pfizer's EHS operations: "We have a structured playbook going in that goes from day one to day 100 with activities to start to integrate an organisation then, depending on the size of the acquisition, it can be a 12- to 18-month integration process."
This involves aligning the new arrivals' management systems and introducing Pfizer's global safety standards.
"It's intensive for our new colleagues," says Dolan -- who came into the company via an acquisition, the £52bn purchase of Wyeth in 2009 -- "but it's the best way of doing it because it's an integration into the Pfizer standards and the culture and expectations from the leaders in our manufacturing and R&D organisations in particular."
"In some cases it's not a burdensome task," he adds, given that parts of an acquisition may have strong EHS performance; his function has to be ready with resources to devote to improving any parts that fall short.
Sometimes the safety performance of an acquisition is so creditable it brings immediate benefit to its new parent. Pfizer enjoyed a more than 20% reduction in its accident rate in 2016 from 0.48 per 100 employees to 0.39. This was partly attributable to the acquisition of sterile injection products maker Hospira, whose 15,000-strong workforce came with an admirably low incident rate. "That affected our numbers positively," he says.
In such cases, the acquired organisation will be supported by Pfizer on the path it was already pursuing and then integrated into the parent's global standards in the medium term. "We do ringfence for a portion of time where we need to, if we recognise there is an additional focus needed to mature that part of the organisations' EHS management system."
Dolan started out in environmental management. He began to add safety and health responsibilities while auditing for Wyeth. "The risk assessment frameworks can be quite similar and the focus is on key controls," he says of the two disciplines. "You can design the management systems frameworks and the controls aspects to be quite similar, understanding where your vulnerabilities are. But the execution of those on a day-to-day basis is quite different."
For his master's degree at Aberystwyth University he concentrated on contaminated land and some of the knowledge gained there has proved useful for the chemistry component of process safety management.
We've given a direction on BS OHSAS 18001/ISO 45001: 'If it makes sense to you locally, then do it'
He says he had registered the significance of safe work at an early age: "My dad is an electrician and when I was a boy I heard all the horror stories."
This left him with a strong interest in electrical safety and he relishes discussions with electrical engineers at Pfizer sites.
"I'm almost exclusively health and safety now," he reflects, adding that the behavioural and cultural aspect to preventing harm makes it a satisfying field.
He joined Pfizer when the company acquired Wyeth in 2009. Moving to a leadership post in a global company was the biggest challenge he has faced professionally, he says. "It was a massive global company and getting up to the pitch of what was required took me three to six months and they were tough, though I have never looked back since."
One important thing he has learned about working at the safety leader level, he says, is to concentrate not just on the relationships with his manager and his own reports but on his peers in the wider senior management team.
When under stress he says he is tempted to default to his comfort zone of data analytics, rather than focusing on maintaining relationships. But he has controlled the tendency: "Now I have smart triggers to pull myself out of there and manage it in a different way from before."
He draws inspiration from colleagues, including Pfizer's new head of manufacturing and her ability to communicate her passion about her work -- "I've no shortage of purpose and passion," he notes, "but it's about how you articulate that within your team or to whoever you are working with."
He says he has also learned a lot from Pfizer's CEO who is piloting the company through a substantial change in its business model: "He has been very smart in how he's done that."
In the lead
Pharmaceutical manufacture is a highly regulated industry; agencies such as the Food and Drug Administration in the US require, and check, adherence to strict quality and product safety standards. "The compliance culture cuts right through the organisation and that holds true for EHS as much as for quality," says Dolan.
"In areas such as electrical safety we are not afraid to standardise with detailed prescriptive requirements globally because of that culture of compliance. It also helps in areas such as process safety where the automation and the standards and the control limits that might be applied from a quality perspective often bolster safety for a process."
Regulatory oversight does not lessen the need for a clear understanding in the EHS function of the safety ranges and the corresponding controls, he notes.
"Our longer-term trajectory has been pretty good," he says of Pfizer's safety metrics. "We benchmark well against our peers." The 2016 total incident rate (TIR) of 0.39 per 100 employees is certainly lower than the pharmaceutical sector average of 0.44.
Having decided that such lagging metrics as incident rates were not going to be enough to drive improvement in safety and health, in 2012 Pfizer's EHS function drew up new leading indicators around that time based on people, systems and leadership.
"Sites can choose from a list under those categories of what is most important for them," he says. The central team works with them to help set performance metrics against these indicators. "It can be anything from leadership inspections and leadership conversations to risk assessments and near-miss reports," he says.
The indicators have replaced raw incident rates on the Pfizer global EHS dashboard, he says. "TIRs are still collected but we don't use them to drive performance."
The other component in the shift was to enable senior managers to make "better decisions" on aspects of safety and health, from resources allocation to choice of projects, by providing them with better data. Information on audit scores, technical metrics and leading indicators in their operating units and divisions is processed by the central EHS team and provided to managers in an easy-to-understand computer dashboard.
"Leaders really appreciate it because it shows them where their key risks are," Dolan says.
The metrics have helped prime the senior managers for better EHS dialogue: "You have leaders coming on to sites discussing process safety performance, occupational hygiene, with a good understanding based on well worked up consolidated information on the key vulnerabilities. So it's gone from clear commitment to commitment plus really good information they can use to drive change."
Pfizer also has a zero serious injuries and fatalities strategy. "We have a strong history like many of our peers in managing the high-hazard work: log-out/tag-out [procedures] and confined spaces," Dolan says. "But it's now about thinking about serious injury and fatality prevention, how we can map that into better data collection and identifying precursors."