Simon Chalk is director of the BioPhorum Operations Group, simon@biophorum.com.

Simon Chalk

While other industry sectors have adopted prepackaged improvement programs since the 1980s, it is only in the past decade that the biopharmaceutical industry has witnessed the rise to prominence of the three-letter acronym (TLA)-based improvement initiative. Business process management (BPM) and human error reduction (HER) are currently in vogue. While much has been promised by these prescribed solutions to improve business performance, much of this promise has proved illusory. Even where measurable improvement has been achieved, it has not always shown where it matters in overall operational performance and on the bottom line.  

The truth is that while most of these approaches do have intrinsic value, unless the approaches are rigorously adapted to the situation of the business and the needs of strategy, the results are unlikely to be what is required. Many managers intuitively know from their own experience that just improving things without a clear link to strategy will not necessarily produce better business results. In some companies, the problem has been exacerbated by changes in priorities and direction caused by the switch from one TLA to another, as disillusion with the previous approach has set in. A few unfortunate organizations have nearly drowned in the resulting alphabet soup.  

Change needs to be focused on delivering the business strategy. It is through realizing the strategy that the company gains competitive edge, and it is this that delivers the bottom line. Moreover, for the biopharmaceutical industry, GMP compliance needs to be up front and center along with productivity and service.  

Many improvement programs do not derive their change agenda directly from the business strategy but come complete with their own. Too often, this leads to change being driven by the dictates of the approach, not by the needs of the business. Things frequently end up being done because the selected approach says "it's a good thing" and not because improving the  way a particular task is done is essential for the company to deliver its strategy. As a result, precious resources can be diverted away from the important things.   

There are no simple solutions or short cuts to improved business performance, but there are some fundamentals upon which a pragmatic, strategy-directed change program can be built. 

Provide the organization with leadership. 

Clearly communicate the values and guiding principles that underpin the strategy and make them real in the form of the appropriate behaviors, policies, performance measures, and reward and recognition systems.

Concentrate on bringing people along and gaining their commitment to the actions that have strategic significance. 

Make sure the basics are in place before becoming more ambitious. It is important to build sound processes, habits, and capabilities into the business to avoid the risk of building on sand.

Direct the improvement where it gives maximum impact in delivering the business strategy by targeting the actions that are key to achieving operational excellence and GMP compliance. 

Make sure that the organization is capable of handling the load being placed upon it. Over-stretching an organization disproportionately reduces effectiveness and generally results in nothing getting done properly.

Invest in training and development to raise the overall capability of the business and particularly those capabilities that support the core competencies. 

Assess each technique, theory, and approach rationally in terms of problems it can solve. After careful consideration, discard what is not useful and adapt what remains to suit the needs of the situation.

Test and refine solutions through experimentation and be prepared to learn from minor mistakes. 

Never lose sight of what you are trying to achieve. 

To perform over the long term, the winners will be those companies that can most effectively deliver their strategies. Any change initiative that is not directed by the requirements of  the strategy and tailored to the needs of the business is unlikely to succeed because it will lack true relevance. It is only by creating a clear link with strategy and following through with a pragmatic approach to implementation that a company makes the best of its strategy and thereby gives itself the best chance of success.  

is director of the BioPhorum Operations Group, 

Articles

Companies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.

Relevance Regained

The scientific and engineering challenges of producing biopharmaceutical products on an industrial scale, historically, have required deep subject matter expertise to be deployed efficiently and with direct responsibility for the result. This 

has remained intact because most facilities were single product (i.e., high volume, low variety) and underwent little change. To compete in the current marketplace, however, pharmaceutical facilities need to be increasingly multiproduct, flexible, fast moving, and more customer centric (i.e., low volume, high variety). The traditional command-and-control model is often not responsive or agile enough to meet this challenge. 

Process-centered organization (PCO) structures have come into fashion over the past few years. PCO structures realign organization building blocks with the value-adding processes in the business. Instead of functional hierarchies being the dominant structure, people are organized into multidisciplinary teams whose goals are focused on managing the end-to-end activities that deliver value to their customer. Team size can extend to many tens of members. 

This concept has become best practice in many industries where lean, fast material and information flows are crucial for survival. Removal of cross-functional boundaries and an element of self-management and empowerment are fundamental. When it works, the value stream can be run with fewer layers of management; headcount efficiencies are increased; and decision-making can be delegated more effectively. Most importantly, communication routes can be short-circuited and the black holes found at organization interfaces are often eliminated. 

Examples of process-centered organization 

Several pharmaceutical companies have successfully made the transition from a traditional organization structure to a new progressive model. The result, in some cases, has been the difference between survival and eventual plant closure. In other cases, the change has been a failure, and a reversal in direction has ultimately been necessary. 

In one groundbreaking example, an inbound materials logistics process team was formed out of separate functions from materials scheduling, warehousing operations, quality assurance, and quality control. The teams were co-located in an office adjacent to the inbound material flow and given authority to work together to meet common objectives. A period of value stream mapping, analysis, and improvement led to redesign of the way of working, adjustments to the allocation of responsibilities, and cross training to enhance the range of skills in the team. Prior to the change, receipt to release could take anywhere from 7 to more than 40 days. Material safety stocks reflected the length and variability of these cycle times. After the change, cycle times were consistently achieved in the one-to-three day range. The team eagerly took up the challenge of empowerment and a culture of "self-direction" emerged from the scheme. Support was given to ensure the interpersonal and team-working skills were in place for the individuals. The project became the starting point for a more demanding redesign in manufacturing areas where a bottom-up approach was taken to transform the wider operational organization. In this case, structure followed strategy in a way that supported irreversible cultural change. 

Another equally informative case study showed how the organization structure in a facility was redesigned in a radical way with less emphasis on improving performance, ways of working, enlarging breadth of skills, and more emphasis on managers becoming process flow owners within a self-directed team arrangement. The lines on the organization chart were the center of attention. In due course, the change was found to be too radical with insufficient focus on business performance improvement. Structure didn't follow strategy, and the organization was changed back to a classic line structure. After a period of reflection, the lessons learned led to adopting a more effective approach. 

A common stepping-stone to PCO is to use more of the matrix-type structure where discipline teams are linked to production process teams by single contact points. These dotted lines build commitment and ownership to the goals of the process team without weakening membership of the functional team. 

When it comes to making a difference, senior managers actually have few levers they can pull. If they want to make change quickly, the options reduce further. The one change that always remains open is organization change. Many senior managers choose to pull this lever as a first option, particularly if they are under pressure to improve performance, reduce cost, or simply to be seen to be doing something. Nothing gets attention more than an organization review that potentially disrupts the status quo. The problem is that organization change can be tricky and may not always lead to the desired result. 

So should the new organization models and theories being talked about be taken on board? How relevant are they to a closely regulated environment like pharmaceutical manufacturing, and, if adopted, how should they be implemented? 

The dilemma is that from a cultural perspective, the pharmaceutical industry is rooted in the "command-and-control" mindset where strong oversight, clear policies, and meticulously defined procedures drive behavior. The requirement is on the employee to learn how a task is to be done and to consistently execute that task again and again (and not necessarily to ask questions why). Managers and supervisors are there to define the task, to ensure it is done right every time by suitably trained people, and to solve problems when they occur. Compliance is key. Experts such as engineers, quality professionals, and support staff are also (highly) trained to focus on their own specialist areas. 

There is no doubt that changes where production operators are given more responsibility for simple maintenance routines, quality control, and batch scheduling, for example, confront existing paradigms. This reality can be seen to be controversial. However, the professionalism and capability of the people that oversee the industries manufacturing sites are more than adequate to ensure these changes evolve in a way that maintains product quality and patient safety. 

For senior managers looking to make an impact, it often makes sense to leave the organization change lever to last position on the list. It then becomes an effective tool with which to make business improvement and cultural change permanent. 

Understanding the difference between success and failure lies not in organization theory, even though it is important to take change management factors into account. It lies in a "back-to-basics" philosophy where material paths are simplified and shortened, knowledge flows to where it is needed, people are given a wider variety of skills training, and wasteful non-value adding activity is eliminated.  

 is director of the BioPhorum Operations Group, 

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

The Transformation to Process-Centered Organization

The butterfly effect is a much cited phenomena where a small change  in a system can have a significant effect on the overall state of the system. In a similar way, relatively inexpensive elastomers can contribute disproportionately to the cost of running a biopharmaceutical manufacturing operation. Elastomers and plastics play a vital role in the operation of a bioprocessing plant, forming gaskets, "o"-rings, and diaphragms deep within the structure of the processing equipment. Their function is to prevent leaks and to separate fluids that should never come into contact. These rubber-like materials are useful because they are flexible, elastic, and can ensure tight seals between hard metal surfaces. 

Over time, and with the harsh temperature, chemical, and pressure cycles that they are subjected to, these materials can become brittle and deformed and  fail. They need to be exchanged well before there is a risk of failure, the consequence of which could be a contaminated product or a dangerous breach of a system. Many biopharmaceutical plants have a large installed base of valves for example, maybe 5000 or more. Each one needs to be maintained correctly to avoid problems. Although the cost of failure is high, the cost of exchange is also high. It is estimated that up to 50% of maintenance activity is consumed by soft parts changeout. Add this to the plant downtime, and there is a clear target for cost-saving scrutiny. So, what scope is there for improvement? Can current practice be challenged? 

The currently accepted and common approach for elastomer changeout is temporal based (i.e., there is a fixed frequency, perhaps annually or biannually, for scheduled maintenance to replace the component). Although this approach is acceptable, it does not take into account the conditions that the elastomer has been subjected to. In cases where the component has been lightly used, it may be exchanged even though continued use would be perfectly acceptable. At the opposite end of the spectrum, severe use could risk failure of the elastomer before its fixed time period had been reached. 

Several engineering leaders in biopharmaceutical operations are questioning this methodology. They are being driven by the unrelenting quest for operational excellence and more effective ways of working. As well as cost savings, there is the realization that their talented engineers could be better deployed working on high value-adding technical projects rather than routine maintenance. One such engineer got into the habit of collecting discarded soft parts from changeovers and visually inspecting them. His curiosity and dislike of waste led him to ask whether there was a better way to systemize the replacement of these items so that they were used for longer but without risking failure in operation. His involvement in a cross-industry benchmarking group and discussions with his like-minded peers showed that better practices did exist. This knowledge spurred him to implement a new way of working, leading to significant cost savings. 

By following simple scientific and risk-based approaches, some companies are now extending the life of elastomers by three, four, or five times. The previous time-based maintenance cycles have been replaced with condition-based cycles whereby the wear and tear on the components are carefully analyzed and graded so that the life of the components can be accurately predicted. The factors affecting wear and tear, such as the numbers of cleaning cycles, temperatures and chemicals used, are recorded to provide a rational basis for analysis and later, measurement. 

Operational data showing variations from predicted results are further sources of insight, shedding light on unknown factors that lead to variability reduction and greater confidence levels predicting component condition. One such root-cause analysis revealed that correct or incorrect assembly of diaphragm valves can contribute significantly to performance of the soft parts. Correct lubrication of fixing bolts and accurate torque setting for instance was discovered to be a contributory factor in the life of diaphragms. 

The question of conformance to specification was another target-rich area with lack of clear standards and nonexistent or inconsistent industry wide test methods. Elastomer suppliers have a long way to go to meet the exacting needs of the biopharmaceutical environment. Performance has historically been the customer problem. Lack of control around changes being a particular concern where the supply chain of suppliers and suppliers' suppliers is not rigorously managed. 

The same industry best-practice sharing group is now advancing the cause by proposing customer-centric standards covering generic-test sequences, visual inspection criteria, and better change control. With agreement by the various stakeholders, these standards will be written into globally recognized codes that set the scene for better industry compliance. 

In this example of a drive for best practice in biopharmaceutical manufacturing, one can trace a direct line from one engineer examining the disassembled parts of a butterfly valve to a new industry system of standards and quality performance levels previously not experienced.  

 are both directors of the BioPhorum Operations Group.  

A look at elastomer changeout times shows how industry knowledge improves operations and cost.