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.
However, even if you have selected one of those typical issues to address, beware of the telltale characteristics of poorly selected and scoped projects, as outlined in Part 1 of this article).If you are a manufacturing vice president, you may want to start with a small group of projects and teams. If you are a process manager, you may want to start with only 1-2 projects. Take on what’s doable; one project done right is better than two projects half done.
Once you have appropriately selected and scoped the project, ask Finance to calculate what the project is potentially worth. Communicate this potential value to your team and to your superiors. Put all projects not selected in a “project hopper.”
6. Complete the project in a timely fashion
Communicate a sense of urgency to the improvement team. As noted, doable projects should be completed within 4-6 months. Timely completion helps maintain momentum, spread enthusiasm and accelerate the learning curve.
Despite the method you are using, the Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) framework can help ensure that the tools appropriate to a particular problem – whether they are Six Sigma or Lean tools – can then be applied in a highly structured and sequenced approach [7]:
- The Define phase sets up a project for success by identifying the problem clearly and determining its financial impact.
- In the Measure phase, the project team comes to better understand the process through various techniques of measurement.
- In the Analyze phase, the data gathered in the Measure phase are subjected to a variety of analytical techniques in order to get at the root causes of the variation or observed waste in the process.
- In the Improve phase, the project team with its understanding of root causes can now identify, test and implement solutions.
- The Control phase is concerned with sustaining the gains achieved by the improvements implemented in the Improve phase.
When new processes must be designed, use the DMADV (Define, Measure, Analyze, Design and Verify) framework instead.
7. Review the project with management
Periodically review the project’s progress and results. Reviews should take place weekly with the Project Champion, who ensures proper project setup and removes barriers to success, and monthly with your superiors. If you have several projects under way, review the overall progress of all the projects quarterly as well. Reviews help keep projects on track and provide an occasion for recognizing, rewarding and reinforcing the behaviors that are critical to success.
8. Demonstrate and quantify value
At the conclusion of the project, verify that the improvements have achieved the desired results and document those results for management. Enlist Finance to document the financial benefits.
9. Select and pursue the next project
10. Make improvement part of your organization’s infrastructure and culture
Improvement should not be treated as a one-off effort or merely as a technique. It should be used as an infrastructure within your organization [8]. With each successive project, you begin to achieve the most important change of all for sustaining improvement: culture change. Ultimately, improvement ceases to be an initiative and becomes the way your function, department or unit works. Don’t be surprised if a gratified management spreads this new way of working – and your name – across the company.
About the Author
Ronald D. Snee is principal of process and organizational excellence and Lean Six Sigma initiative leader at Tunnell Consulting in King of Prussia, Pa. He earned a Ph.D. in applied and mathematical statistics from Rutgers University. His work has been recognized by 20 awards including the American Society for Quality’s Shewhart and Grant Medals and the American Statistical Association’s Deming Lecture Award.
References
4. Hoerl, R. W. and R. D. Snee Statistical Thinking – Improving Business Performance, Duxbury Press, Pacific Grove, Calif., 2002
5. Snee, R. D. , “Dealing with the Achilles’ Heel of Six Sigma Initiatives – Project Selection,” Quality Progress, March 2001.
6. Snee, R. D. “The Hard Part: Holding Improvement Gains,” Quality Progress, September 2006, 53-55.
7. Snee, R. D. “When Worlds Collide: Lean and Six Sigma,” Quality Progress, September 2005, 63-65.
8. Snee, R. D. and Rodebaugh , W., (2002) “Enhance Your Project Selection Process - Every Company Should be Able to Manage Its Project Portfolio and Create an Overall Organizational Improvement System,” Quality Progress, September 2002, 78-80.
