Mastering Change: a Company Commitment

For contract service organizations, staying technically current has never been as important, or as challenging, as it is today. In addition to increasing FDA regulation and growing customer demand, the industry plans to bring a skyrocketing number of new products to market. A broader (and better) understanding of the genetic basis of disease and genetic variations across individuals has driven this new product growth, as science develops more individualized disease solutions.

In addition, new types of intellectual property are emerging, creating knowledge areas that stretch far beyond any existing pharmaceutical patents that we have known. The result is a rate of change that is accelerating with almost exponential speed.

These developments have boosted both competition and opportunity to new levels. The prize – success and prosperity – will go to those who can master the changes and stay current with emerging technical demands. Those who do not or cannot keep up with these changes will be lost.

Staying current must be a company commitment, involving every individual from the top down, because it involves both people and equipment. Technically current people working with outmoded equipment can do only so much; state-of-the-art equipment is useless in the hands of people who cannot use it to the best advantage. Staying current also involves money and time, but committing these resources to technological currency is an investment in the company and the employee. It will, without doubt, pay off in bottom-line terms and improve employee morale.

The Challenge of Keeping People Current
Keeping people current with technology, regulatory and other fields of knowledge is a daunting, but achievable goal. The diversity of the workforce in a pharmaceutical company re-quires a comprehensive program that addresses the needs of management, line workers and technical workers. Each segment of the workforce plays a part in the development and manufacturing process and yet, while they are intimately related, they each possess a distinct set of needs.

While the workforce should not be overlooked, technical workers (including scientists, engineers, laboratory personnel and others involved in the development and formulation of drugs) may have the greatest need for technological currency. They may also be the most at-risk group in terms of losing their technological currency.

Education Must be Pursued
If scientific and technical employees are to keep up with the changes that can make the difference in the success or failure of your company, continuing education must be pursued as a matter of company policy in skill areas that are of benefit to both the company and the employee.

In fact, it is a good idea to allocate a budget line item amount to help employees through ongoing education programs. Consider financial assistance for work-related courses that have present-or even future-applications at your company. A tuition-assistance program may cover as much as 100% of tuition, books and most fees. Universities, professional organizations and conferences are excellent resources for continuing education.

Other methods and techniques of advancing and leveraging your company’s knowledge base include:

– Sharing. Set up a program that allows employees to share the knowledge they gain in their courses and seminars. Institute formal and informal shared learning encounters. For example, set up a brown-bag lunch for a weekly, one-hour presentation in which a conference attendee can share what he or she learned at the conference.

– Mentoring. Managers and peers, including senior staff, can mentor new and other employees with an interest in learning new skills in a less formal way. Mentors draw from personal experience and their own education to support on-the-job learning for colleagues.

– Communications. Use the company intranet or internal newsletter to share learning. Encourage employees to post interesting articles to various people in the company. Make it easy for them to do so by providing a scanner and clerical resources.

– Involve the company in shaping the curricula of local universities.

A major challenge is that employees, ambitious and eager to climb the corporate ladder, may see learning (especially shared learning) as a distraction. They may perceive it as a waste of time that gets in the way of their “real” work, maybe even a punishment or a sign that management does not value their in-company contribution. Employers must make it clear through compensation and promotion that this is not the case. They must relate promotion or pay incentives to continuing education and employees’ willingness to share it. This may be the only way to bring learning into a corporate setting.

Employees must be given time to pursue development and education. This may be difficult from a management perspective, because the press of daily business must be met above all else. However, the reality is that employee development is necessary to future survival. One method for allocating time is to have employees write up an annual education plan that includes conferences, seminars and/or courses they want to pursue. This approach at least provides some form of scheduling, which can minimize inconvenient absences.

The Technically Obsolete Employee
A difficult concept for employers is that of the technically obsolete employee. The issue of what to do with these workers, whose technical or scientific capability has fallen well below that required by the position, raises some interesting questions.

How did the employee become technically obsolete? Who was responsible for this condition? Was a system in place to keep the employee technically current? Did the employee fail to take advantage of the system? Were expectations clear regarding technological currency? Were managers instructed to encourage and reward the individual to keep up to date? If the employee is very out of date, how is it affecting his or her job performance? Is the employee still, in some way, making a positive contribution to the company? The answers to these questions will determine the company’s course of action.

Looking for the Performance Gap
What an employer must really be concerned with, in the case of an out-of-date employee, is the performance gap (i.e., the gap between what needs to be done and what the employee can do). Some performance gaps may be easy to measure. For example, if the employee is responsible for new equipment in the operation or monitors a bench-scale operation involving a new molecule and simply doesn’t understand the equipment, this represents a training problem and may be remedied. However, if the employee is also required to interpret results and adjust the process to achieve different results, but proves incapable of doing this, the performance gap may be a little more difficult to measure – and more difficult to remedy.

In either case, by identifying the performance gap, employers can plan for future requirements. That is, knowing where the employee stands now lets the employer determine where he or she has to be to achieve technical currency.

Needs Assessment
Every job needs to be redefined periodically to keep the employee current and keep the company competitive. In a traditional sense, needs analysis and assessment examines the skills and knowledge to stay current in the position. This is a task for management, which must stay abreast of industry trends and must even crystal ball a little, looking ahead to understand what technologies are on the rise. Remember: jobs rarely are purely technical or purely people-oriented, or simply focused on things. Technological currency, important as it is, is likely only one requirement in a technical position. Most often, needs analysis will reflect a combination of complex skill and knowledge areas.

Functional analysis can be an especially good approach with, say, engineering positions, in which the individual performs a large number of tasks. Rather than conducting a job analysis to identify specific tasks, the analysis instead identifies major functions within the position. What skills and knowledge must the individual have to do the job? After this question is answered, the employer can set objectives for technological currency.

For example, the management engineer may engage in production planning, personnel requirements, facility and equipment requirements, forecasting materials and formulating budgets. The training needed to perform these activities might include how to build a capacity requirement plan or training in various forecasting techniques.

On a production line, however, people are concerned with the operation and maintenance of a specific system. The employer can use different techniques to produce a generic and system-specific learning objective for the training and evaluation of personnel. In designing and setting up training for production skills at our company, for example, a team of experienced workers and supervisors was assembled. Familiar with the system, the team brainstormed and developed a list of tasks in order to determine which ones must be trained. They based this list on frequency, difficulty, criticality and the consequences of error or poor performance.

As new lines are installed and new products and regulations come on-stream, line workers are brought up to date by supervisors and managers. There are at least two techniques that can work well in bringing line workers up to date on technology changes: verification and document analysis.

The verification technique allows training programs to be determined based on work at other facilities on the same or similar tasks. Contract manufacturers and developers may not have access to this sort of program. For a pharmaceutical company, the document analysis technique may work better. It can be especially valuable when accurate procedures and other job-related documents are available. Document analysis is a simplified technique for determining required knowledge and skills directly from operating procedures.

For high-level executives with decision-making responsibility, problem-solving or judgment needs, a traditional task analysis may fail to identify the skills required to perform a given task or job. In this case, a cognitive task analysis can be performed to identify and to describe the cognitive components of their tasks and job requirements.

For example, a chief executive officer with an undergraduate degree in chemical engineering and a graduate degree in business earned 20 years ago may be technically obsolete in an engineering sense, but that is immaterial to the position of chief executive officer. Important skills include the ability to make wise decisions regarding overall company effort, such as committing top management to a program that results in keeping the entire company technically current.

Keeping The Facility Current
A program should include a plan for keeping the facility technologically current, an effort that blends future vision with financial management. With long lead times for installing new lines and costs that easily run into the tens of millions of dollars, pharmaceutical manufacturers must be certain that equipment additions and changes that are planned today and installed in 18 months, for example, will have relevancy and utility for a number of years.

In order to meet the ever-changing needs of both customers and operating facilities, companies must perform continuous process improvement. By using statistical process control (SPC) techniques, a company can monitor and evaluate the progress of their processes. The information gleaned from such analyses can provide detailed information on how well a plant is performing, how consistent the product quality is, how to determine if improvements need to be made and what the effects these changes will have on operations.

There are several other ways that a company can keep itself on the cutting edge of technology: by reviewing the literature and trade journals, visiting other facilities and attending trade shows and conferences. The art of networking is critical because it provides opportunities for the exchange of ideas. A lesser-known resource is that of the suppliers – the companies whose equipment is deployed and used every day in a working facility. By asking questions of these vendors, companies can learn what is going on in the industry and how things are changing, while also apprising themselves of the risks and benefits of those changes.

The internet has changed how the world finds and reads about new technology and information. Most companies have their own web sites, which offer a wealth of information. Judicious use of the internet can sometimes help companies avoid reinventing the wheel.

Working in teams also helps to put things in perspective. Teams are a great way to maintain high quality and increase output. Asking equipment operators who know their job how they can improve their output or increase quality may provide the best insight to boosting overall output, quality and employee satisfaction. Both sponsors and vendors must remember: everyone wants to feel important. Knowing that the jobs they perform are appreciated and welcomed in a team scenario can provide that for all employees.

A Process, Not An Event
Achieving and maintaining technical currency, in the plant or with the people, must be an ongoing process for a pharmaceutical manufacturer and developer. However arduous it seems, it will pay dividends in terms of meeting and beating the competition, better serving the customer, generating higher and more consistent product quality, improving management and labor relationships and creating a workforce of capable, motivated employees.