Ten Steps to Process Improvement, Part 2

Following a proven framework can get an improvement program off the ground and ultimately, lead to success for managers at all levels.

By Ronald D. Snee, Ph.D., Principal, Tunnell Consulting, Inc.

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As the first part of this article (www.pharmamanufacturing.com/articles/2006/206.html) demonstrated, not all improvement programs have to come from top management. Numerous mid-level pharmaceutical manufacturing leaders have successfully initiated and executed process improvement projects that have enhanced operations, generated financial benefits and advanced their careers. How? By adhering to the following ten-step path, or a similarly proven framework for achieving and sustaining improvement.

1. Demonstrate the need

As the great pioneers of quality like Deming and Juran tirelessly pointed out, all work is accomplished through processes. Thus, advancement entails improving those processes. Therefore, you should begin by identifying the process most critical for the success of your function or department and pinpointing the need for improvement.

Often the need for improvement is self-evident – discarded batches, frequent rework and wide variations in the process. Where the need is less clear, you can identify key performance metrics, collect data and identify gaps in the performance of the process. Most importantly, you must be prepared to show how those performance gaps adversely affect operational performance, the bottom line and other relevant measures, demonstrating what is possible and how improvement will benefit all stakeholders.

2. Become familiar with proven improvement methodologies

As Arie DeGeus, former head of planning for Royal Dutch Shell says, “The ability to learn faster than your competitors may be the only sustainable competitive advantage.” That holds true both for organizations and for executives who want to excel in them. Don’t be afraid to learn and learn fast about the proven process improvement methodologies – Six Sigma, Lean and a combination of the two, Lean Six Sigma.

Six Sigma is a quality measurement and improvement program. Its use promises dramatic gains in process excellence and helps reduce defects and errors; cuts cycle time; improves yield, service and compliance; increases customer satisfaction; and enhances the bottom line. Lean helps manufacturing and service businesses achieve remarkable efficiency in processes by eliminating wasted time, materials and expenses; reducing non-value added activities; and increasing the speed and output of the operation. Lean often can be used to establish a foundation of more efficient processes that can then be further optimized and controlled with the powerful statistical tools of Six Sigma. Lean Six Sigma combines the power of Six Sigma to reduce process variation with the power of Lean to reduce waste, providing a holistic approach that can be applied to improvement opportunities of all kinds [4].

Although Lean Six Sigma is arguably the most powerful approach, it’s not necessary for you to be an expert at this point or to choose definitively among these approaches. In the beginning, your goal is to get enough of a grasp of the potential of these rigorous approaches to make a real difference in manufacturing. Once the initiative is underway, there will be additional opportunities to acquire a working knowledge of the appropriate methodology, but first you must get the go-ahead from your superiors.

3. Build support in the management structure for real solutions

Management may readily agree that certain processes could use some improvement, but they may be leery of approaches like Six Sigma or Lean, especially if they have had no experience with them. This is a make-or-break moment in your effort to make a genuine difference. Traditional approaches to improvement such as inspecting in quality after the fact, problem-solving and Statistical Process Control, simply no longer suffice in the pharmaceutical industry’s high-pressure environment. It would be counter-productive for the organization and for you personally to undertake improvement using approaches that are unlikely to maximize gains in performance and sustain them over the long term. You must convince superiors that the only approach worth taking is one that gets at the root causes of problems in processes and corrects those problems once and for all.

However, the easily demonstrated argument that methodologies like Six Sigma and Lean can accomplish those goals is, by itself, unlikely to win the backing of superiors. You must also align the initiative directly with the boss’s goals, which may include financial as well as operating goals. But don’t stop there. Make it clear that you will involve Finance to verify the financial benefits that the project can be expected to produce and to document the actual financial outcomes when the project is completed. When provided with hard financial numbers, the boss will have a compelling and demonstrable basis for approving and, in all likelihood, enthusiastically supporting the initiative.

4. Prepare yourself/team for the effort

Once you’ve got the go-ahead, you must select a team to undertake the effort. Select your best people for the job. Training will be necessary. Consider hiring someone from outside the organization, who can mentor you and your team but also transfer knowledge so that you can pursue improvement independently in the future. Be prepared to:

    • Provide overall direction, making sure that projects are aligned with business needs.


    • Communicate the what, why and how of process improvement for the organization, the expected benefits and progress to date.


    • Enable, coach and counsel - providing team members with training, resources and time to work on the project.


    • Recognize, reward, celebrate and reinforce the desired behavior with frequent project reviews.


  • Training is best accomplished as part of real-world improvement projects. With the help of an expert, you and your team should be able to learn as you go while meeting the most rigorous objectives.

5. Pick your project

Project selection is arguably the toughest part of process improvement [5, 8]. In addition to aligning with the goals of your boss, a worthy project should be doable (in 4-6 months), significant (have a measurable impact on the organization) and relatable (people in the organization can relate to it and will feel gratified by is success). The types of projects typically selected involve such issues as process flow, product quality, product delivery, process and product cost reduction, waste reduction, process variation, process operating “sweet spot” and process and product robustness.

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