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Will lean manufacturing techniques save the industry? Excerpts from our recent webcast shed light on many of the issues facing pharmaceutical manufacturers

Recently, Pharmaceutical Processing’s Editor-In-Chief Mike Auerbach moderated a live webcast titled Lean Manufacturing, Gaining Efficiencies and Maintaining Compliance on the Plant Floor. This webcast was designed to discuss lean manufacturing, six sigma and the issues regarding implementing these technologies while maintaining regulatory compliance. The wide ranging discussion touched on numerous topics such as IT implementation, management buy-in and support, corporate culture, PAT, data gathering and analysis, FDA’s quality initiatives, and other manufacturing topics designed to improve efficiency.

The panel of experts who joined Auerbach included Bill Fitch, Vice President of Life Sciences, Business & Decision, who discussed how pharmaceutical manufacturers can implement lean and maintain regulatory compliance.; Dr. Pankaj Mohan, Manager of Global Process Engineering at Eli Lily & Company, who talked about his firsthand experience in implementing lean six sigma in a pharmaceutical production environment; and Dennis Constantinou, Senior Director of Life Science Industry Strategy at Oracle Corporation, who discussed how information technology can aid in a lean enterprise transformation. The excerpts below highlight some of the topics discussed and questions answered during the live webcast. To view the webcast in its entirety log onto http://www.pharmpro.com/leanstrategies/.

Mike Auerbach: Bill, can you give us an example of where process improvement potentially conflicts with compliance?

Bill Fitch: That’s a good question. When we look at the value of making a change to a manufacturing process, we need to evaluate if it is a minor change or major change. If it is a minor change, simply identifying how that change impacts the quality aspects and safety aspects of the medicine, and then providing a report to FDA at the end of the year will be satisfactory. However, if it is a moderate or major change, that would require a supplement to be submitted to FDA. So at the end of the day, you need to evaluate the change that you’re making and the potential challenge that it causes from a commercialization standpoint, especially if it is a product that is already currently on the market.

Mike Auerbach: Since lean initiatives and regulatory compliance can sometimes be at odds, how can IT technology alleviate this challenge? Dennis Constantinou: Traditionally compliance and lean initiatives have actually been at odds with each other because of the heavy burden of compliance. But with IT solutions, the way they’re designed with the ability to automate much of that workflow, you can now take that burden off of the floor and automate it as part of your process, thereby giving you the assurance that you’re not only meeting compliance, but that compliance is now part of your workflow. It automates the process.

Mike Auerbach: Dr. Mohan, do you think that value stream mapping is the foundation in all lean environments, and how does value stream mapping link with the DMAIC process?

Dr. Pankaj Mohan: Well, the value stream really sets or fills the hopper that feeds the DMAIC process. So instead of just doing this in a non-structured way, a value stream map can thus provide a very structured and a critical way of thinking through the whole process before you actually begin the process.

Dennis Constantinou: I’d like to comment on that. Before anyone begins any lean initiative, we really need to have an understanding of our business processes. And those business processes need to be highly defined, and not only take it from a business process, but expand that to an entire value plan. We need to be able to do that and have that highly documented and be aware of those processes to the nth degree in order for us to go in and implement any type of solution. Thereby, we can go in and even perform that cost benefit analysis that you were talking about, and being able to do that. Without that, I find it will be very difficult to approach a lean initiative in any kind of structured manner.

Mike Auerbach: Do any of you see MES as a help to lean manufacturing and what kind of ROI is seen from implementing these systems?

Dennis Constantinou: I think if you’re looking at a manufacturing execution system as part of your ability to track, measure, and if you’re going into a tapped initiative within your company, I believe that MES will be actually a critical part of the overall solution, and it should be part of your MRP or ERP solution that you’ve implemented within your manufacturing facility.

Dr. Pankaj Mohan: I would again say that one has to balance the benefits in the extent of one’s implementing MES to the efforts that go behind it, especially I’m talking about computer system validation that goes behind that. So it has to be a good balance between the two.

Mike Auerbach: Can you provide an example of a lean initiative for a validated documentation flow, if possible?

Dr. Pankaj Mohan: What I can relate is I can understand the question in terms of if you take a validation document, the whole flow of the document before it gets approved is very windy. A lot of people have to comment. A lot of people have to edit and so on and so forth. What I can say is that it is good to map the document flow with time lines to kind of achieve a certain pre-agreed delivery date and quality.

Mike Auerbach: Dennis, is it difficult to integrate new lean IT initiatives when legacy systems are firmly entrenched?

Dennis Constantinou: Well, I think you’d have to look at the challenge that’s faced with the types of legacy systems that you have, and specifically the integration of that information. There are tools out there, which allow you to integrate information from a variety of legacy systems to help you execute on your lean initiatives. But, I think one of the key issues is that when you’re looking at lean, you want to extend the same benefits of lean across your enterprise. And if your enterprise is such that it’s composed of a variety of legacy systems, of which there is tremendous complexity and a duplication of information and the streamlining process breaks down in terms of your business flows, then I think it’s incumbent upon you to look at your cost benefit analysis, how you streamline those processes and what you really need in order to move forward. I think the key goal here is to understand that lean is a journey. It’s not something that you’ll start today and end when the project is over. It’s a continuing improvement. It stands quite a period of time within your company. In fact it can continue on in a variety of different forms. So ideally you should be looking at your IT solutions as they need to grow with the complexity of your company and the changes in your value stream.

Dr. Pankaj Mohan: I’d like to add to what was said is that moving from old to new is an opportunity in itself to raise the learning from the old system and exponentially learning the operations of the new system. One has to build in the lean six sigma effort in that timeline. Moving from a manual operation into a fully automated case had a lot of learning that had to happen, and it took a while before the process stabilized because people were picking up the learning.

Dennis Constantinou:And, Bill, from a validation perspective, you’re talking electronic records and signatures and moving in that environment. Growing from entrenched legacy systems and moving on into changing that out into a newer system, as Pankaj had mentioned earlier about automating business processes, do you see that as an advantage to a company from a validation perspective? Has it changed the validation environment?

Bill Fitch The big complexity with legacy systems, especially if there is poor documentation kept on the life of that system, typically the systems are not able to be easily validated cost effectively. Unfortunately, I think what most folks have found is that if you apply a practical approach and risk-based approach to achieving validation in those systems and trying to make those systems Part 11 compliant, typically it is found that it is more cost effective and less a burden on resources to simply retire the system and bring in new technology.

Mike Auerbach: Bill, Can lean and PAT be implemented simultaneously, and if not, which should be done first?

Bill Fitch Well, you know, I think when we talk about PAT, PAT is able thus to achieve lean. I don’t really know if there’s an issue with doing them separately or doing them together. Maybe other folks here on the panel could discuss the value or the disadvantages of that. But I would think that it starts with making a decision to have an initiative. I think that the two together or separately, I don't really see that’s an issue. You guys have any difference of opinion on that?

Dennis Constantinou: Well, I also think that PAT is part of lean, but it’s also a very critical component of your quality systems approach. As you’re defining your point of entry into lean, you need to go to a cost basis analysis and really prioritize what you’re going to be achieving. If your initiative into lean isn’t starting on a quality system approach, but starting from a process area where you’re trying to streamline an existing well documented process, then you may be looking at a different priority ranking in terms of when you bring in PAT in that overall initiative as you’re moving forward. Again, I just want to reiterate that lean is a journey. So you may be looking at a variety of things that you want to start off in on that lean journey, you need to prioritize, make that first step, and then continue on through that process. I think that’s where you’ll see PAT coming in, in terms of when you start moving into that quality system environment because that’s a whole different area in and of itself.

Mike Auerbach: Is it practical to apply lean to an entire facility at the same time, or should individual departments go lean separately, and if so, is there a preferred order to implement lean?

Dennis Constantinou: There has to be a transformational change within your company that’s led at a fairly senior level in terms of lean implementation and lean initiative. It is something that is a journey. It takes quite a bit of time and effort. It’s a cultural change that occurs. It would be very challenging to take that on corporate-wise all at once. But it has to have, not only corporate sponsorship, but then a ground swell approach coming up from a variety of different departments at the same time, to really seed the ground with successes as you move forward.

Bill Fitch: Show some gains, which is important to get people on a large scale to buy into this.

Dennis Constantinou: Be able to see successes and then build on those successes, build best practices in terms of your lean initiatives and your six sigma practices. Also don’t forget, anything with regards to either lean or six sigma requires a considerable amount of training and education of your employees who are going to adopt these principles. So all of that has to be factored in, in terms of how you start rolling out these throughout your company.

Mike Auerbach: Dr. Mohan How do you overcome the “don’t fix it if it ain’t broken attitude” that pharma has always had about new approaches, especially if the approach brings to light the inefficiencies of processes that were developed and maintained by the same management that you were trying to get buy-in from?

Dr. Pankaj Mohan: I sympathize with the question. It is true, probably for all pharma. In my presentation I was very passionate about leaving a slide that said leadership. This is a cultural change. Typically manufacturing is run based on costs and other things. As all of us get more and more pressure on cost, we have to move the paradigm in terms of manufacturing differently, not just as cost but as a revenue stream as well. There’s no short answer to the question. I personally feel that leadership is really important and successes do breed perfection in the system. So communicating that and taking it to the cynical few, and I hope few, to kind of help them change their mindset is really important.

Mike Auerbach: How would you propose implementing a lean manufacturing program? Set up a corporate strategy first, then deploy, or work on a small pilot project, then spread the gospel throughout the organization?

Dr. Pankaj Mohan: Well, I personally feel that snowballing, as in starting small and building on, in a big corporate landscape will take too long. There has to be enough strong leadership to drive the paradigm shift at all levels. That’s where you see the most benefit.

Mike Auerbach: When upgrading manufacturing equipment, what types of options should be looked at in the way of control systems in order to achieve advances toward leaner manufacturing?

Dr. Pankaj Mohan: When exchanging equipment, I look at it personally, is that it’s a good time to look at the overall control strategy, and to see if there are opportunities here that could add value to either reducing the various improving process, adding more capacity, operational convenience and so on and so forth. So, I mean, there isn’t a blanket answer here, but I think one should look into this from the context of the whole process, and try to take this opportunity to maximize a return from any advanced control or modified equipment set.

Dennis Constantinou: I was going to echo the thought about business processing. I think it’s one of the critical factors, if not the critical factor in making that decision in terms of the control systems that you’re going to implement and the equipment that you’re going to change out in terms of how does it augment that process. Since many processes are inter-linked, that equipment and control process may be pervasive throughout your entire manufacturing. It’s kind of a multi-variant analysis you have to do in that regard. But I think business processing is extremely important in that decision-making.

Mike Auerbach: Is software validation at the enterprise level and manufacturing data gathering level a stumbling block to implementing IT solutions with lean and six sigma?

Bill Fitch: I would say absolutely not. Does it add additional complexity? Well, sure. Whenever you make a change, you have to deal with evaluating, taking your worst approach and looking at what the current system is, how the system supports the business to make a determination if revalidation is necessary or not. But I think that is something that is inherent in the business and those changes are something that have to be dealt with. Simply being pragmatic about it is the way that you need to approach it.

Dr. Pankaj Mohan: I personally feel that there is no lack of data collection. We can collect collectively in this industry a lot of data. The challenge is to convert this data into knowledge. That is where the various levels of data technology interaction happens. I think that the key challenge is basically taking the data forward and converting it back into useful knowledge that can help lean and can help the process.

Mike Auerbach: How do you reconcile the massive amounts of paperwork generated during validation with the concepts of lean manufacturing?

Bill Fitch: That is a difficult one to reconcile because obviously the very exercise of validation is rigorous development of documentation. So I don’t really know if you can apply the principles of lean to validation. Again, it is a set of discreet activities and different types of documents that have to be put together to show evidence/proof that a system has been developed, tested and functioning and operates for its intended purpose. Unfortunately, you can’t do that with less documents. However, you can take a risk-based approach and be pragmatic about it. In the old days, people would validate all of the functionality of a system. Now the approach is slightly different in that we identify where the regulations impact the functionality or how the system is used. And we’re able to scale validation accordingly, so we don’t do necessarily testing of everything. We don’t conduct the same types of tests on all of the different functionality aspects of the system. So, I guess in a way, I don’t know if I would call that lean, but it is pragmatic.

Dr. Pankaj Mohan: I mean, I personally feel that the validation is crying to be leaned. Many companies have taken a lot of initiatives. I think the key here is to kind of set up the framework with risk-based approach, and then have an efficient documentation trail and execution protocol.fs y:> n >t

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