The tough economic environment and the patent cliff have dramatically increased pressure on the traditional pharmaceutical industry to find ways of increasing efficiencies and decreasing costs. This, in turn, has resulted in a renewed emphasis within these organisations on the deployment of continuous improvement (CI) programmes such as Lean Sigma, TPM and 5S.

Unfortunately, history suggests that most of these programmes, after initial success, will ultimately fail to make a sustained impact. While it is a truism that such programmes will only succeed if they effect a deep-seated cultural change within an organisation, there is often a lack of appreciation that such a change requires a large commitment of resources (people and investment) and an understanding that a culture will take a considerable amount of time to alter.

Understandably, in the current environment, many organisations have neither the resources nor the time to make such a change. So, what can be done?

Digital CI in pharmaceutical manufacturing

One strategy that is increasingly being deployed is the use of integrated automation and information technologies such as manufacturing execution systems (MES), laboratory information management systems (LIMS), computerised maintenance management systems (CMMS), overall equipment effectiveness (OEE) monitors and data warehousing to facilitate and accelerate the cultural change that is required to make CI programmes successful.

The pharmaceutical industry recently began to accelerate its adoption of these technologies and is rapidly closing the gap on other sectors that have traditionally taken the lead in adopting new initiatives such as these. This can, to some extent, be explained by the change in approach of regulatory bodies, which have adopted a much more pragmatic approach to the introduction of these technologies in recent years.

"Less daunted by the technology, digital natives are more likely to focus on the power of the information part of IT."

An additional factor that may also account for the increased adoption rate is the coming of age and the promotion to decision-making positions of the first wave of digital natives. The term ‘digital native’ refers to a person who was born during or after the general introduction of digital technologies and, through interacting with digital technology from an early age, has a greater understanding of its concepts. It is their comfort with information technologies that has begun to lead to a paradigm shift in the approach to the adoption of new digital systems.

Less daunted by the technology, they are more likely to focus on the power of the information part of IT, rather than the hardware more commonly thought of in relation to it. It is the handling and mining of the vast amount of information available as result of these new technologies that can provide the real competitive advantage.

Power of IT in pharma CI

Introducing such technologies eliminates a large number of non-valuing activities by automating much of the administrative work necessary in the daily running of a modern pharmaceutical factory. This is particularly true if the systems are broadly interfaced, thus allowing information to move from system to system without the need for repeated manual data entry.

Research suggests that only 10-20% of the activity that takes places on a typical pharmaceutical site is value-added in the true lean sense: something the customer is willing to pay for and does not expect as a minimum (such as quality). When software systems are introduced and effectively interfaced to each other and to legacy systems such as enterprise resource planning, they can dramatically reduce non-value-adding activities.

This in turn permits a large amount of resources to be freed up to be involved in CI activities (Rottapharm currently has 80% of staff involved in CI activities to some degree). The more people involved, the faster and more secure the cultural change.

"Research suggests that only 10–20% of the activity that takes places on a typical pharmaceutical site is value-added in the true lean sense."

Such technologies also make CI activities, and work in general, more engaging for a technology-savvy workforce. It is difficult to convince people who are accustomed to shopping, banking and even paying taxes online in an automated and efficient way, that you are striving for world-class manufacturing, when they are burdened with repetitive manual paperwork in their daily work. The use of online paperless systems then, not only makes the CI programmes themselves more efficient, but they also promote the view that the company is relevant and forward looking.

A central tenet of this strategy must also be, as much as possible, to deploy and integrate new systems using internal personnel. The use of external resources, such as consultants, is not only more costly, but it also tends to promote the view that these systems are being imposed upon the factory. In contrast, if the deployment is carried out by internal personnel, it is more likely to be perceived as part of the natural development of the site capabilities in line with an ethos of CI. This is particularly true if people are given the opportunity to enhance their skills as a result of the project. No longer is it the case that these projects can only be carried out by IT specialists; 95% of personnel who have worked on deployment projects carried out on our site have no formal IT qualification.

In a fully paperless factory, almost every activity takes place either on or in an automated system. This means that huge quantities of information are generated every day. In order for the strategy to be successful, it is important that this data is used to drive the CI culture. A key element of this is the principle of ensuring that the data, or at least data correlated into key indicators, is available as universally as possible.

This encourages a sense of ownership and a certain amount of friendly competition, both of which are key elements in driving the culture change. In addition, the warehousing and subsequent mining of this data can provide powerful insights into the performance and opportunities for improvement within a factory. These can be provided by the standard monthly reports and by ad hoc reports developed specifically to investigate particular issues usual as a result of a CI activity.

Finally, the efficiencies gained by the introduction of such technologies will also inevitably result in sustained cost reduction in of themselves. These reductions release some of the cost pressures and enable more time for the cultural change to take hold.

Technology: distraction or enhancement?

There is a joke: "The factory of the future will have two employees, a man and a dog. The man will be there to feed the dog. The dog will be there to stop the man touching the equipment." This humour plays on some of the unrealistic expectations and fears people have about the introduction of the technologies we have discussed.

One of the most common objections to this strategy, particularly from those involved in deploying CI programmes, is that the introduction of technology only serves to alienate people on the production floor and distracts from getting the basics right first.

An often cited example is that of the daily huddle. It is said that the very fact that production line owners manually gather performance data and then discuss it daily with their supervisors during the huddle is a fundamental element in driving a culture of CI. And that the introduction of technology to this process is somehow a distraction that weakens its impact. In our experience, this is not the case.

Firstly, data that is automatically gathered tends to be more accurate, timely and requires no non-value-adding administrative costs on behalf of the line owner. It also eliminates the administrative tasks associated with collating data from all areas into factory KPIs.

"95% of personnel who have worked on deployment projects carried out on the Rottapharm site have no formal IT qualification."

Secondly, the fact that the data is instantaneously available factory wide only serves to enhance the value of the huddle because the participants are aware that their results are simultaneously available to everybody else in the factory, so there is true and visible accountability. So, far from weakening the daily huddle, the introduction of these systems actually serves to enhance them.

Another common objection to this strategy is that the validation requirements are prohibitive. The 1997 final draft of the FDA 21CFR Part 11 compliance guidelines for use of electronic systems in the pharmaceutical industry went a long way to establishing this perception. The fact that most solutions on the market at the time were still in the development phases, and had not yet stabilised, has done nothing to diminish that perception.

However, in the last ten years the landscape has changed considerably. In 2003, the FDA issued a new guidance document, "Part 11, Electronic Records; Electronic Signatures – Scope and Application", which relaxed some of the earlier criteria with the objective of removing the disincentives for innovation. At the same time, many of the solutions being offered on the market reached a level of maturity and stability that allowed configurable off-the-shelf solutions to become available. These solutions come with a pre-validated software core that, in theory, only requires configuration in order to be deployed on customer’s sites. In reality this is not always possible as some customisation is inevitably required. But if this is kept to a minimum then validation cost can be considerable reduced.

In addition, the typical presumption in the implementation of these systems is that, because they will operate in a pharmaceutical environment, there is a need for full validation. However, a considerable number of these systems, which can be implemented to reduce non-value-adding activities, do not contain GMP data and will never be used for the purpose of release.

These systems can then be introduced using a minimalist risk-based validation approach.
The final major objection results from the fact that IT projects have had a justifiable reputation for being high-risk. Cross-industry research would suggest that, on average, only 20% of all IT projects are deemed successful, where success is defined by being on time, on budget and meeting all the performance requirements.

Golden route to successful CI

Our experience shows that these risks can be greatly reduced by following a few golden rules. Firstly, choose your software supplier carefully and interview the team. They are key partners in the project’s success. Secondly, choose a configurable off-the-shelf software solution and avoid, as much as possible, customisations. This reduces development risks, minimises validations and makes upgrades easier.

Thirdly, use internal personnel to deploy and validate the software. This has the dual benefit of reducing cost and improving the improvement culture, but it also has the benefit that, because experience in the deployment of these projects is accumulated, they are inevitably deployed faster than could possibly be achieved by training external personnel in the existing site systems for each new project.

If you are looking for a strategy that will achieve a sustained cultural change and drive a CI revolution within your organisation, then one backed by integrated automation and information technologies may be an option. It is not the only one, but for Rottapharm’s Dublin site it has proven transformational. The use of digital systems has been key to creating the space for CI to flourish and empowered employees to achieve sustained cultural change.