When it comes to packaging machinery purchasing strategies, AstraZeneca's project manager David Mason has advice gleaned from experience. He says, "The most important thing I can tell you is to bring together your operators, mechanics, technicians, material handlers, and a supervisor or a packaging manager. You can go out and buy the best piece of equipment on the planet, but if you don't get their ownership, it's going to be a failure. Get these people involved from the beginning-from the User Requirements Specification [URS] through Factory Acceptance Testing [FAT]-through everything."
Mason delivered the advice during a presentation at the 2008 Pharmaceutical Packaging Forum (www.packworld.com/ppf) held earlier this year in Philadelphia. He said that AstraZeneca has purchased packaging equipment via a lean approach for years. "We have a lean environment that involves meeting our customer needs, reducing our warehouse space [needs], and developing a business case for machinery purchasing decisions," he said.
Start with the basics
Mason made the following "big-picture" points:
• Use a small, cross-functional team of seven or less people in order to get things accomplished.
• Develop a project charter that includes marketing and sales information, as well as projections for the next five years.
• Select [equipment] that's flexible.
• Specify how to purchase equipment and how to decide upon vendors.
• Develop a URS to present to original equipment manufacturers, and negotiate aftermarket services.
• Understand that lean packaging equipment purchasing and machinery operation involves reducing waste. Mason said, "Astra Zeneca used to produce large lots of product-20,000 to 30,000 cases. Now we might run 1,000 on that same equipment that was designed for larger runs, so that's a challenge for the organization."
• Know that areas of waste can include overproduction or production ahead of demand, which can cause waste in the form of expired product.
• Look for wasted motion during the transportation of product between the warehouse and the packaging line, in staging areas, and where product is loaded into areas on packaging equipment.
Know your packaging lines
Surprising as it may sound, Mason said that a lot of people do not understand their packaging lines. "They know they package [into] a bottle or a blister, but they really don't know what the details are," he said. "So before you even write your URS, get a packaging line layout. If it's a new line, make sure to get the space you need. I have heard instances where people buy the equipment and then realize, 'Hey, it doesn't fit in there!'"
Mason also recommended that companies determine what kind of control systems they want. Decide if you want to monitor your line. Do you want to tie your equipment together?
He advised packagers to make use of production data about their operations. "Look at those numbers, look at your Standard Operating Procedures, safety [issues], and the complexity of the machines. Do you have highly skilled people, or people who have not had a lot of training?" If employees are inexperienced, he cautioned, consider a less-complex machine.
"We make every effort to talk to different people in the company in order to buy a machine with flexibility," said Mason. "Marketing is always [trying] to increase sales, especially in over-the-counter products. I used to work in OTC, and every week they had a different marketing strategy." He said such changes can prove costly. "If we had known [earlier of such a marketing strategy change], we might have [acquired] a machine that could have done [what the marketing strategy wanted]," he said.
'Kaizen'-like approach
Mason sees value in mapping your company's processes, material, people, and packaging flows. "Look at that and [recognize areas of] weakness. That's what you are going to build into your URS. Have a Kaizen-like [a philosophy or method of continuous, incremental improvements] focus," he advised. "Get together a group of specialty mechanics and people like that, and walk through the line and identify different aspects of it, including the defects, the opportunities, and your total production management."
This personnel group should determine such factors as: How many times does a machine go down? What's the mean time between failures? How many times do you use spare parts?
Mason recommended "waste walks," where you walk around the line with operators, mechanics, technicians, and other stakeholders to look for waste. "Make sure you can efficiently stage your components with the equipment. That's the kind of waste we are looking for," he said.
He suggested that color-coding could be helpful-one color for process movement, one for material movement, etc. Evaluating incoming components/materials to determine if they are acceptable is also a valuable practice. "I found out before we did lean packaging that we accepted everything. What happens if you are out on the floor [and learn] that [the materials] won't run on the line? There is always the equipment versus component [issue]. So I highly recommend that when you actually create a purchase order, you bring together [people with machinery expertise and people with component or material expertise]. We do that all the time, and then there is no finger-pointing," Mason said.
Changeovers
Mason offered this changeover analogy: "If you have ever flown Southwest Airlines, you know that as you're departing the plane out the front door, you see people coming in behind you cleaning. So by the time the last person gets out, the plane has been cleaned. That's the philosophy you should have in your packaging lines. Once that last bottle goes down, you should have somebody changing over the line. We had a case packer [with changeover time of] an hour and a half that we are now doing in 10 minutes. We have cappers that once took 40 minutes that now take five minutes."
He provided another recent example of an AstraZeneca purchasing decision that involved changeovers. "We just did a project with a case packer in which two vendors' [machines] were about the same price. We required a 10-minute changeover on a case packer. One vendor said they couldn't do it. The other vendor agreed that they could do it. How they did it was with a robotic system," he said.
"The changeover on the machine was designed to work with the touch of a button. It was expensive, and I had to convince management that was the way to go," he continued. "But when we did the business case, [we noted that] an operator, mechanic, material handler, or custodian could go over and push that button and change over that piece of equipment. It paid for itself in nine months."
Mason said that AstraZeneca's changeover and ramp-up time is simply the time from when the last case leaves the line until the first case comes out of the line again. "We set a standard of 10 minutes, if possible, on every changeover. We are training operators now to do it as a lean team, as a group effort. We're asking for zero ramp-up time," he said.
An often-overlooked factor in wasted labor and changeovers, he said, involves loading materials into equipment. He advised packagers to consider where they're loading materials from, consider the height where materials are loaded, the machine magazine's length, and how far [the magazine] is from the product being loaded.
Another important factor that some people may not consider is purge, he added. "This is how to clean [the machine] after a run. We package a lot of tablets, and purge is very important. If you miss a purge, all of a sudden, you have a [potential] recall because the pharmacy found a wrong tablet, and you can't figure out where it came from. We spend a lot of money on equipment purge. My philosophy is to keep [equipment areas] open so that you can see them."
Another AstraZeneca change made to speed changeover had to do with spare parts setups. "We used to store everything in cabinets," he recalled. "We store everything in carts now. We made a cart area, and the parts are all identified. So we roll the cart right down to the line with everything we need. It's a huge advantage because we are not looking through drawers for everything."
Equipment training and standardization
Mason commented on pharmaceutical packaging machinery in particular when he told the PPF audience that pharmaceutical companies do not do a good job of training compared to [other industries] that use lean practices. "I was at a seminar, and a customer in the beverage industry said his company spent $50,000 on training for one machine. If I said I was going to spend $50,000 for training on one machine, I would probably be looking for another job. But we have increased our training, and [the company believes] standardization of equipment is very important, too," he said.
"For example," Mason said, "we just put in a labeler. We had no training to do because we had three other [similar machines]. It went [online] in a week!"
User requirements specifications
Mason made several recommendations pertaining to issuing a URS to packaging equipment vendors:
• Factor in the cost of ownership. "Ask what it takes to run that machine in one, three, or five years," he recommended. "Know what the failure rate is, what the recommended spare parts include, and why? What's the OEM's service like?"
• Remember the basics, such as "cost, delivery options, exceptions, and everything that's there in your URS."
• When it comes to Overall Equipment Effectiveness (OEE) and URS, Mason said that AstraZeneca does not factor in OEE, primarily because there are variables that can't be controlled early on in the process. "The OEE is more of our number on our performance; not the vendor performance," he explained.
• A good communication plan is important. "Identify one person from the plant or the project and one person from the OEM to communicate," he advised. "You can have other people from the team communicate, but you have to let the others know. Because you don't want people making decisions and then suddenly you get a bill with something you knew nothing about. We make it very clear up front to the vendor-if it's not approved by our project manager, you just ate it."
Determine equipment goals
Mason presented the following tips:
• Know what you want the equipment to do. This sounds simple, but it helps to write down a general description. Note the physical constraints in your plant, such as room height. Do you have to cut a wall, or lift the machine in by crane?
• Consider motors with quick disconnects for maintainability: If your motor blows, you want to be able to change it out in a couple of minutes.
• Use sensors to indicate such things as low fills, high fills, crooked labels, etc. Always try to detect a reject in the equipment so you don't have to do rework down the line.
• Design maintainability into equipment decisions. That means maintenance-related issues. "We don't use any lubricant on our equipment. If we find equipment like that, we stay away from it," Mason said.
Mason told the story of users who go on the Internet and [search for a] cartoner. "They get 10 cartoner suppliers, and they invite all 10 in. You don't need to do that," he stated. "Equipment engineers should be responsible enough to know what's out there to try to lessen the options. The end-user company is going to review [potential cartoner suppliers] with the team, draw up a list of questions, and go back and forth [with prospective vendors]. After evaluations, schedule vendor presentations. We look at lean factors on the equipment. After the presentations, visit vendor sites."
Mason stressed that when the vendor comes in and conducts a presentation, "make sure you emphasize the cost of ownership. This is from the vendors [that use] their changeover, ramp-up time, and service [information]."
He noted, "Service is huge. I can't buy a piece of equipment that takes eight months to get change parts. I don't know what company can wait for eight months for change parts. And the components people, one thing I am going to do with them, after we pick the equipment supplier, is to put them in a room together with the equipment person. That's a must. We are going to have them discuss the specifications and everything right up front."
Have a FAT plan
Mason believes that employing a FAT plan is part of doing business in healthcare. "We've used a risk-based approach [for about two years], and it works. We put a labeler online in four days. That used to take two weeks for validation," he said.
He attributed that success to good engineering principles. "Have a FAT plan, and know exactly how you are going to [use] the machine. Test everything," he advised. "We [identify] that information, so we don't get overcharged on the FAT. And they [the vendor] know as much as possible at the FAT, so you don't have to do it in the plant. That makes [for] a quicker startup."
Mason described a beverage plant he visited: "They practice lean processes. They helped out AstraZeneca a lot! So just don't stay in pharmaceuticals when you are looking at equipment. Look at companies that are practicing lean. We could have gone through a [pharmaceutical] vendor or end-user facility and never [experienced what we did at the beverage plant]," he explained. "Half the companies in pharmaceuticals don't practice lean. They don't understand it. That's why we are going to companies outside the pharmaceutical industry."
Purchasing and ROI
More than once, Mason referred to "the dreaded purchasing agent." He said, "All they usually care about is how much they can save [on a machine purchase] and how much they can tell their boss they saved, be it $20,000 or $100,000. They don't care about the cost of ownership. They don't care if it costs the company $200,000 dollars a year to run that piece of equipment."
Mason provided advice on how to alleviate potentially major operating costs down the road. "We came up with an agreement on the machine performance. After it's installed for a month, the equipment [vendor] comes out, and we evaluate it. If it doesn't meet the [performance specs], then they have 60 days to bring it up to the spec. Or, we actually can send that piece of equipment back and get our money back," he said.
Another idea: Develop a spare parts availability guarantee. "We have penalties if you can't get the spare parts from Europe in 48 hours, unless you identify the spare parts up front or from the U.S. in 24 hours. That's because we are running a lot of changeovers, and we don't have time for waste or for the line to be down, since we only keep a two-week inventory in the warehouse. I am more worried about the cost of ownership than getting a discount with [purchasing] the machine," Mason articulated. "And we [now] have got purchasing working in that manner. When we first started this, the [purchasing] guy said, 'A $200,000 dollar difference! We are not getting that machine.' Well, we showed them we were saving $400,000 dollars in five years. Then his boss saw it. That's what's more important."
OEE benefits
Following Mason's PPF presentation, an audience member asked, "Do you have any data on what your overall efficiency was prior to introducing the lean structure?" Mason offered two examples from AstraZeneca packaging lines. The first example, he said, pertained to a bottling line: "We put a buffer in, and we also went over and did all the equipment for changeover. [Our OEE] used to be 20 percent. I don't know if anybody knows, but usually pharmaceutical companies [operate] at about 30 percent OEE. Beverages are much higher. Right now, that line is at 52 percent OEE, and we are doing 10 changeovers a week on a four-day work week."
Another example: "We had a blister line [operating] at 18 percent that's now running at 70 percent," he said. "There was a big effort from changeovers and materials. We used all lean manufacturing and Six Sigma tools. That's probably one of the highest [OEE numbers] in the industry."
Mason expressed a similar success story with filling equipment. "We used to buy high-speed fillers," he said. "But speed is not as important to us as it once was. This filling machine used to run at a 350-a-minute [rate], but the changeover was horrendous, and the OEE was about 20 percent. We brought a machine that does about 250 a minute, but the OEE is up to 60 percent, so we compensated for the speed. Everybody says you have to have speed, yet efficiency is more important. You can run a 350-per-minute machine with an OEE at 20 percent, or you can run at speeds between 200 or 250, but with 60 to 70 percent OEE and get much more product out the door."
Read more about the PPF at www.healthcarepackaging.com/go/22
-By Jim Butschli, Editor
Mason delivered the advice during a presentation at the 2008 Pharmaceutical Packaging Forum (www.packworld.com/ppf) held earlier this year in Philadelphia. He said that AstraZeneca has purchased packaging equipment via a lean approach for years. "We have a lean environment that involves meeting our customer needs, reducing our warehouse space [needs], and developing a business case for machinery purchasing decisions," he said.
Start with the basics
Mason made the following "big-picture" points:
• Use a small, cross-functional team of seven or less people in order to get things accomplished.
• Develop a project charter that includes marketing and sales information, as well as projections for the next five years.
• Select [equipment] that's flexible.
• Specify how to purchase equipment and how to decide upon vendors.
• Develop a URS to present to original equipment manufacturers, and negotiate aftermarket services.
• Understand that lean packaging equipment purchasing and machinery operation involves reducing waste. Mason said, "Astra Zeneca used to produce large lots of product-20,000 to 30,000 cases. Now we might run 1,000 on that same equipment that was designed for larger runs, so that's a challenge for the organization."
• Know that areas of waste can include overproduction or production ahead of demand, which can cause waste in the form of expired product.
• Look for wasted motion during the transportation of product between the warehouse and the packaging line, in staging areas, and where product is loaded into areas on packaging equipment.
Know your packaging lines
Surprising as it may sound, Mason said that a lot of people do not understand their packaging lines. "They know they package [into] a bottle or a blister, but they really don't know what the details are," he said. "So before you even write your URS, get a packaging line layout. If it's a new line, make sure to get the space you need. I have heard instances where people buy the equipment and then realize, 'Hey, it doesn't fit in there!'"
Mason also recommended that companies determine what kind of control systems they want. Decide if you want to monitor your line. Do you want to tie your equipment together?
He advised packagers to make use of production data about their operations. "Look at those numbers, look at your Standard Operating Procedures, safety [issues], and the complexity of the machines. Do you have highly skilled people, or people who have not had a lot of training?" If employees are inexperienced, he cautioned, consider a less-complex machine.
"We make every effort to talk to different people in the company in order to buy a machine with flexibility," said Mason. "Marketing is always [trying] to increase sales, especially in over-the-counter products. I used to work in OTC, and every week they had a different marketing strategy." He said such changes can prove costly. "If we had known [earlier of such a marketing strategy change], we might have [acquired] a machine that could have done [what the marketing strategy wanted]," he said.
'Kaizen'-like approach
Mason sees value in mapping your company's processes, material, people, and packaging flows. "Look at that and [recognize areas of] weakness. That's what you are going to build into your URS. Have a Kaizen-like [a philosophy or method of continuous, incremental improvements] focus," he advised. "Get together a group of specialty mechanics and people like that, and walk through the line and identify different aspects of it, including the defects, the opportunities, and your total production management."
This personnel group should determine such factors as: How many times does a machine go down? What's the mean time between failures? How many times do you use spare parts?
Mason recommended "waste walks," where you walk around the line with operators, mechanics, technicians, and other stakeholders to look for waste. "Make sure you can efficiently stage your components with the equipment. That's the kind of waste we are looking for," he said.
He suggested that color-coding could be helpful-one color for process movement, one for material movement, etc. Evaluating incoming components/materials to determine if they are acceptable is also a valuable practice. "I found out before we did lean packaging that we accepted everything. What happens if you are out on the floor [and learn] that [the materials] won't run on the line? There is always the equipment versus component [issue]. So I highly recommend that when you actually create a purchase order, you bring together [people with machinery expertise and people with component or material expertise]. We do that all the time, and then there is no finger-pointing," Mason said.
Changeovers
Mason offered this changeover analogy: "If you have ever flown Southwest Airlines, you know that as you're departing the plane out the front door, you see people coming in behind you cleaning. So by the time the last person gets out, the plane has been cleaned. That's the philosophy you should have in your packaging lines. Once that last bottle goes down, you should have somebody changing over the line. We had a case packer [with changeover time of] an hour and a half that we are now doing in 10 minutes. We have cappers that once took 40 minutes that now take five minutes."
He provided another recent example of an AstraZeneca purchasing decision that involved changeovers. "We just did a project with a case packer in which two vendors' [machines] were about the same price. We required a 10-minute changeover on a case packer. One vendor said they couldn't do it. The other vendor agreed that they could do it. How they did it was with a robotic system," he said.
"The changeover on the machine was designed to work with the touch of a button. It was expensive, and I had to convince management that was the way to go," he continued. "But when we did the business case, [we noted that] an operator, mechanic, material handler, or custodian could go over and push that button and change over that piece of equipment. It paid for itself in nine months."
Mason said that AstraZeneca's changeover and ramp-up time is simply the time from when the last case leaves the line until the first case comes out of the line again. "We set a standard of 10 minutes, if possible, on every changeover. We are training operators now to do it as a lean team, as a group effort. We're asking for zero ramp-up time," he said.
An often-overlooked factor in wasted labor and changeovers, he said, involves loading materials into equipment. He advised packagers to consider where they're loading materials from, consider the height where materials are loaded, the machine magazine's length, and how far [the magazine] is from the product being loaded.
Another important factor that some people may not consider is purge, he added. "This is how to clean [the machine] after a run. We package a lot of tablets, and purge is very important. If you miss a purge, all of a sudden, you have a [potential] recall because the pharmacy found a wrong tablet, and you can't figure out where it came from. We spend a lot of money on equipment purge. My philosophy is to keep [equipment areas] open so that you can see them."
Another AstraZeneca change made to speed changeover had to do with spare parts setups. "We used to store everything in cabinets," he recalled. "We store everything in carts now. We made a cart area, and the parts are all identified. So we roll the cart right down to the line with everything we need. It's a huge advantage because we are not looking through drawers for everything."
Equipment training and standardization
Mason commented on pharmaceutical packaging machinery in particular when he told the PPF audience that pharmaceutical companies do not do a good job of training compared to [other industries] that use lean practices. "I was at a seminar, and a customer in the beverage industry said his company spent $50,000 on training for one machine. If I said I was going to spend $50,000 for training on one machine, I would probably be looking for another job. But we have increased our training, and [the company believes] standardization of equipment is very important, too," he said.
"For example," Mason said, "we just put in a labeler. We had no training to do because we had three other [similar machines]. It went [online] in a week!"
User requirements specifications
Mason made several recommendations pertaining to issuing a URS to packaging equipment vendors:
• Factor in the cost of ownership. "Ask what it takes to run that machine in one, three, or five years," he recommended. "Know what the failure rate is, what the recommended spare parts include, and why? What's the OEM's service like?"
• Remember the basics, such as "cost, delivery options, exceptions, and everything that's there in your URS."
• When it comes to Overall Equipment Effectiveness (OEE) and URS, Mason said that AstraZeneca does not factor in OEE, primarily because there are variables that can't be controlled early on in the process. "The OEE is more of our number on our performance; not the vendor performance," he explained.
• A good communication plan is important. "Identify one person from the plant or the project and one person from the OEM to communicate," he advised. "You can have other people from the team communicate, but you have to let the others know. Because you don't want people making decisions and then suddenly you get a bill with something you knew nothing about. We make it very clear up front to the vendor-if it's not approved by our project manager, you just ate it."
Determine equipment goals
Mason presented the following tips:
• Know what you want the equipment to do. This sounds simple, but it helps to write down a general description. Note the physical constraints in your plant, such as room height. Do you have to cut a wall, or lift the machine in by crane?
• Consider motors with quick disconnects for maintainability: If your motor blows, you want to be able to change it out in a couple of minutes.
• Use sensors to indicate such things as low fills, high fills, crooked labels, etc. Always try to detect a reject in the equipment so you don't have to do rework down the line.
• Design maintainability into equipment decisions. That means maintenance-related issues. "We don't use any lubricant on our equipment. If we find equipment like that, we stay away from it," Mason said.
Mason told the story of users who go on the Internet and [search for a] cartoner. "They get 10 cartoner suppliers, and they invite all 10 in. You don't need to do that," he stated. "Equipment engineers should be responsible enough to know what's out there to try to lessen the options. The end-user company is going to review [potential cartoner suppliers] with the team, draw up a list of questions, and go back and forth [with prospective vendors]. After evaluations, schedule vendor presentations. We look at lean factors on the equipment. After the presentations, visit vendor sites."
Mason stressed that when the vendor comes in and conducts a presentation, "make sure you emphasize the cost of ownership. This is from the vendors [that use] their changeover, ramp-up time, and service [information]."
He noted, "Service is huge. I can't buy a piece of equipment that takes eight months to get change parts. I don't know what company can wait for eight months for change parts. And the components people, one thing I am going to do with them, after we pick the equipment supplier, is to put them in a room together with the equipment person. That's a must. We are going to have them discuss the specifications and everything right up front."
Have a FAT plan
Mason believes that employing a FAT plan is part of doing business in healthcare. "We've used a risk-based approach [for about two years], and it works. We put a labeler online in four days. That used to take two weeks for validation," he said.
He attributed that success to good engineering principles. "Have a FAT plan, and know exactly how you are going to [use] the machine. Test everything," he advised. "We [identify] that information, so we don't get overcharged on the FAT. And they [the vendor] know as much as possible at the FAT, so you don't have to do it in the plant. That makes [for] a quicker startup."
Mason described a beverage plant he visited: "They practice lean processes. They helped out AstraZeneca a lot! So just don't stay in pharmaceuticals when you are looking at equipment. Look at companies that are practicing lean. We could have gone through a [pharmaceutical] vendor or end-user facility and never [experienced what we did at the beverage plant]," he explained. "Half the companies in pharmaceuticals don't practice lean. They don't understand it. That's why we are going to companies outside the pharmaceutical industry."
Purchasing and ROI
More than once, Mason referred to "the dreaded purchasing agent." He said, "All they usually care about is how much they can save [on a machine purchase] and how much they can tell their boss they saved, be it $20,000 or $100,000. They don't care about the cost of ownership. They don't care if it costs the company $200,000 dollars a year to run that piece of equipment."
Mason provided advice on how to alleviate potentially major operating costs down the road. "We came up with an agreement on the machine performance. After it's installed for a month, the equipment [vendor] comes out, and we evaluate it. If it doesn't meet the [performance specs], then they have 60 days to bring it up to the spec. Or, we actually can send that piece of equipment back and get our money back," he said.
Another idea: Develop a spare parts availability guarantee. "We have penalties if you can't get the spare parts from Europe in 48 hours, unless you identify the spare parts up front or from the U.S. in 24 hours. That's because we are running a lot of changeovers, and we don't have time for waste or for the line to be down, since we only keep a two-week inventory in the warehouse. I am more worried about the cost of ownership than getting a discount with [purchasing] the machine," Mason articulated. "And we [now] have got purchasing working in that manner. When we first started this, the [purchasing] guy said, 'A $200,000 dollar difference! We are not getting that machine.' Well, we showed them we were saving $400,000 dollars in five years. Then his boss saw it. That's what's more important."
OEE benefits
Following Mason's PPF presentation, an audience member asked, "Do you have any data on what your overall efficiency was prior to introducing the lean structure?" Mason offered two examples from AstraZeneca packaging lines. The first example, he said, pertained to a bottling line: "We put a buffer in, and we also went over and did all the equipment for changeover. [Our OEE] used to be 20 percent. I don't know if anybody knows, but usually pharmaceutical companies [operate] at about 30 percent OEE. Beverages are much higher. Right now, that line is at 52 percent OEE, and we are doing 10 changeovers a week on a four-day work week."
Another example: "We had a blister line [operating] at 18 percent that's now running at 70 percent," he said. "There was a big effort from changeovers and materials. We used all lean manufacturing and Six Sigma tools. That's probably one of the highest [OEE numbers] in the industry."
Mason expressed a similar success story with filling equipment. "We used to buy high-speed fillers," he said. "But speed is not as important to us as it once was. This filling machine used to run at a 350-a-minute [rate], but the changeover was horrendous, and the OEE was about 20 percent. We brought a machine that does about 250 a minute, but the OEE is up to 60 percent, so we compensated for the speed. Everybody says you have to have speed, yet efficiency is more important. You can run a 350-per-minute machine with an OEE at 20 percent, or you can run at speeds between 200 or 250, but with 60 to 70 percent OEE and get much more product out the door."
Read more about the PPF at www.healthcarepackaging.com/go/22
-By Jim Butschli, Editor
