Mark Crawford, Contributing Writer09.05.12
While not a great deal has changed during the last year or two when it comes to assembly and automation technology, medical device manufacturers, however, are using assembly and automation in more creative ways to meet increasing customer demands for speed, smaller batches and lower costs, as well as for quality control and validation purposes.
According to Noel Taylor, chief technology officer for Sunnyvale, Calif.-based Modified Polymer Components, which manufactures and assembles parts and products for medical device OEMs, the industry is looking for assembly and automation processes that have higher levels of statistical quality.
“Statistical process control is being pushed down to the component-level manufacturer,” said Taylor. “It is common for customers to want fully qualified processes very shortly after proof-of-concept prototypes. In order to accomplish this, we need to have teams working on projects at the very beginning that can invent and optimize in parallel.”
Creating a medical device with plenty of quality at the right price point is always challenging. Most of the innovation that is happening in assembly and automation at present involves finding new ways to improve efficiency and reduce cycle times and still meet increasingly complex design needs. The increase in multiple uses or functions for devices is forcing contract manufacturers and vendors to look at assembly and automation with a more creative perspective. For example, balloons are now being used as platforms for drug delivery and targeted tissue ablation, which has brought a host of new manufacturability and assembly challenges to the forefront: How can the drug or electronics be attached to the balloon effectively, without doubling the cost of the balloon? How does the manufacturer ensure the majority of the drug, in the right dose over the right time frame, gets to the targeted location? What innovation is required to be sure the electronics stay on the balloon when the balloon is deflated?
These requirements often turn the manufacturer/assembler into the problem solver.
Interface Catheter Solutions, a Laguna Niguel, Calif.-based medical balloon developer and contract manufacturer, helped solve this assembly challenge by modifying the balloon surface.
“We discovered that balloon surface modification improves the quality and cost of drug/electronics adherence and will likely play an important role as these new markets evolve with new drugs, variable drug dosing and more elaborate sensing and ablating flexible electronics,” said Mark Geiger, vice president of sales and marketing Interface Catheter Solutions.
A rough or textured surface creates a more effective surface area for bonding. Currently, several steps are involved in attaching a drug to a balloon with the correct dose and consistency. A textured surface adds even more value because it may eliminate one or more of those steps, improving drug-eluting balloon quality and reducing cost.
“We think this will also be true with mounting electronics to balloons, which is the current trend in treating atrial fibrillation and high blood pressure with renal denervation,” Geiger continued. “The goal, of course, is inflating the balloon to deliver therapy, and deflating it, without leaving the electronics behind when it is removed.”
Another example from the balloon market is the balloon shaft weld for higher-pressure balloons with lower profiles and smaller-diameter shaft tubes. Traditional thermal or laser welding or adhesives do not provide the level of customization required to meet the requirements for these new designs.
“Interface determined that thermal compression bonding, with custom welding dies for a specific balloon catheter shaft material and diameter, create a uniform, robust weld that won’t leak because the two materials are bonded to each other without deforming the inner lumens of the tube,” said Geiger. “This process also increases the rated pressure of the balloon catheter system.”
Kahle Automation, a Morristown, N.J.-based designer and builder of automation systems for the medical device industry, is another company that develops new technology when it needs it.
“As a custom automation company, if existing solutions for even the simplest operation do not meet our requirements and standards for quality and consistency, or may not be able to meet the rigorous functional conditions required for high-speed automation, we will develop our own technology,” said Julie Logothetis, president of Kahle Automation.
A recent example is Kahle Automation’s tip-forming technology, which was developed to meet customer quality and output requirements for high-speed, consistent tip-forming for various materials for a line of catheter assembly machines.
“Our most recent innovation is a fluid-dispensing system that allows us to dispense various fluids with a wide range of viscosities to a tolerance of +/- 5 microliters,” said Logothetis.
Modular Automation
Many contract manufacturers lean toward semi-automated assembly processes that are nimble and scalable so they can work with rapidly changing OEM demands and get products to market faster.Smaller product lots and shorter product life cycles also keep full automation at low priority because of the time involved to validate the larger-scale process, as well as the high cost in machinery and time.
“Using modular automated assembly equipment is a good way to reduce the overall cost of production,” said Rudolf Pavlik, product development manager for ASI, a Millersburg, Pa.-based contract manufacturer of OEM healthcare products and single-use systems.“Demco Automation’s Wedge system, for example, is highly customizable and a relatively inexpensive way to automate lower-volume projects.”
This system consists of either tooled or untooled stations with distributed controls that plug into a base chassis (bench-top, rotary dial, inline and walking beam models) for immediate start up. Each station is a tooling plate that is equipped with an on-board controls box that includes a controller, wiring, valve manifold and input blocks; they also come with pinning, tapping and key holes that align with docking stations on the chassis platform. Stations can operate alone as a tabletop station or plug into the base chassis to operate in a manual, semi-automatic or automatic mode. According to Pavlik, Demco’s proprietary Windows-based PLC programming (programmable logic controller; primarily used to control machinery) is easy to operate; stations are programmed by simply checking boxes on a PC screen for a sequence of designated inputs and outputs.
Another cost-effective approach is using modular robotic or (X) (Y) programmable work stations that serve as multifunctional, positive positioning systems.
“Interchangeable tooling cassettes can be loaded to the work cell incorporating many different assembly methods, like heat staking, heat insertion, ultrasonic, etc.,” added Colin Drewek, account manager for PTI Engineered Plastics, a Macomb, Mich.-based provider of plastic injection molding and assembly services. “This also provides a cost-effective assembly alternative for low- to medium-volume applications.”
Automation also can save money at the end of a production run by inspecting the finished product. This eliminates human errors, speeds throughput and validates the process.
In the balloon world, for example, the time spent manually inspecting balloons, and the somewhat subjective reporting that results, contribute significantly to the overall high cost of balloons. Structural flaws that can lead to balloon failure often are difficult to identify, categorize, and measure, especially using the manual contact measurement and inspection tools that are still considered the standard today. Such tools also are inferior for determining precise critical dimensions such as interior diameter, wall thickness, and concentricity. This all leads to higher costs, more scrap, increased product returns, low yields, and more recalled product.
“Using an automated, computerized balloon visual inspection can provide full dimensional and defect measurement and recording in under a minute—reducing the cycle time of inspection by about 30 percent,” said Geiger. “Our custom software, three years in the making, is designed to detect and measure flaws like fisheyes, gels, crow’s feet and strain lines—the defects that balloon manufacturers care about the most.”
Keep It Clean!
Assembly and automation perform most efficiently (and therefore-cost effectively) in a modern, clean manufacturing environment with environmental controls to minimize the ambient particulates.
“The environment controls provided by the manufacturer are a good place to start when designing an automation system,” said Ben Webster, automation validation manager for ATC Automation, a Cookesville, Tenn.-based that provides assembly and testing solutions for medical device companies.
For example, laminar air flow is a big help in controlling particulate matter. If laminar air flow is present, the automation vendor can design the equipment to utilize this feature to help control unwanted particulates.If a laminar flow does not exist, other techniques can be utilized such as enclosures.
“At this point, every influence of air flow should be examined to understand each mechanism that moves air within the automated equipment,” said Webster.“A good example of this is a robot in an automation system that began to experience erratic failures.It was determined that the cooling fan was pulling the conductive dust from the assembly in and exposing the control board, causing shorts in the circuit.”
According to Bob Rice, ATC Automation’s applications team leader, “clean-ability” is another area that is critical in the designing of automation systems. “Machines should be designed to reduce pockets or crevices that can harbor foreign substances or even stray piece parts,” he said.
Plastic or stainless steel shielding can make a machine easy to clean.If parts or materials exit the normal product flow, they can be easily identified and removed.Every precaution should be made to avoid contaminating finished and approved parts and materials; using advanced vision systems can optimize cleanliness in these areas.
“Nothing is more important than having experience with these issues when designing automation equipment,” said Rice.“Trying to correct cleanliness errors once the equipment is on the production floor is too costly.Therefore, a device manufacturer should seek a reputable automation vendor that can discuss these issues during the design phase of a project, not during the installation phase.”
For certain products that are especially sensitive to contamination, manufacturing in a clean room is the preferred solution. For example, Vesta, a provider of silicone and thermoplastic contract manufacturing services for medical device manufacturers, recently constructed a new, Class 10,000 clean room at its silicone manufacturing facility in Franklin, Wis.
“While the majority of our medical device customers’ requirements can be supported in our Class 100,000 controlled room environment,” said Jim Fitzgerald, executive vice president of sales and marketing for Vesta, “our certified Class 10,000 clean room provides an environment with higher particulate air filtration to meet very strict requirements for those customers who require it for compliance with their product manufacturing specifications.”
The Class 10,000 clean room features a HEPA filtration system, temperature and humidity controls and requires strict gowning procedures. Manufacturing processes that will be carried out include silicone molding, silicone extrusion, secondary operations and sub-assembly and packaging processes that require a maximum of 10,000 particles (0.5 microns or larger) per cubic foot of air.
Designing an Assembly System
Assembly and automation options should be considered at the very beginning of the design process. The device or part should be designed with assembly in mind—if the parts do not join together easily, automation will not be as reliable and more completed assemblies will be rejected, adding time and cost to the production runs.
“The fit of each part to another is critical for successful automation,” stated Ron Szostek, vice president of engineering for Concep Machine, a Northbrook, Ill.-based company that designs and manufacturers special-purpose machinery and factory automation systems for medical device assembly and test applications. “It is very important to consider designing in features that help guide the parts together—lands, chamfers and assembly guides go a long way in supporting the assembly process. It also helps for designers to consider parts for assembly in a manner that allows the part to go together without special tooling considerations.”
Szostek recommends prototyping high-risk processes. Sometime during product design, or at the beginning of the development of a machine user-requirement specification (URS), vendors may identify areas of the assembly process that demonstrate a high risk or require a new concept for tooling.
“In these instances, the development of a prototype can be used to confirm the process or tooling approach,” said Szostek. “These prototypes are most helpful if the part samples of the assembly components are in a stable design stage. Developing the production tooling at this stage with a simple prototype can confirm key data, such as the feasibility of the process, as well as whether it will work within a cycle time window, generate any particulate or damage the assembly.”
The next step after obtaining feedback on the assembly processes is making some fundamental choices regarding the type of machine that is desired.
“Feed rate becomes an important factor at this stage of the development,” said Szostek. “For example, the use of pneumatics for actuations in the machine is a good choice; however, they are limited to speeds that do not cause premature wear of the devices. Cam-actuated processes, on the other hand, will provide much higher machine speeds but require a higher investment than pneumatics do.”
The URS is an important guide for the automation project because it enables suppliers to provide accurate and complete proposals for the equipment.
“The manner in which customers write the URS varies widely; some are very detailed while others are intentionally vague and open to interpretation,” said Szostek. “In either case, the ‘must haves’ for the machine project must be clearly defined to ensure project success.”
Conduct a comprehensive process failure modes and effects analysis (PFMEA). A complete and detailed PFMEA provides invaluable information about the machine process. High-risk priority numbers are a strong indication that a process is not going to be robust in a machine, or that it will be a high-maintenance area once the machine enters production. Modification of the process at this phase of the project can be a low-cost, low-risk solution for the automation. Making these changes early in the engineering design of the machine also lessens the cost impact to the overall project.
Finally, Szostek said, develop a project plan and monitor it often. The project plan should contain key data points that relate to the project schedule and show both supplier and customer key inputs for the project. Once the project plan has been developed, it needs to be reviewed and maintained as a living document. It should be reviewed whenever the project team has a major meeting or review event.
“Adjustments need to be made that show both the original base-line and real-time adjustments that have been implemented to accommodate changes in the project schedule,” said Szostek. “This approach becomes vitally important during the de-bug phase of machine development. De-bug is the phase when unexpected time may need to be allocated in the schedule to solve a problem on the machine that could not be foreseen and is not apparent until the system is under power and beginning to cycle.”
Process Validation
Automation is being used more for monitoring, trending and archiving manufacturing process parameters. Validated process parameters can then be stored in recipe files, recalled at point of use by part number and continuously compared with in-process parameters provide immediate feedback for improved understanding of the process, stability and robustness of the parameters affecting product quality.
“Product testing outcome as a part of the assembly has additional meaning for a customer who is a recipient of the data,” said Pavlik. “Fully integrated validation process monitoring and archiving provide detailed information to customers during audits, or as a part of the documentation shipped with a finished product.”
In addition to recording and archiving manufacturing process parameters, ASI also is integrating product serialization.
“The use of QR (quick response) codes provides continuity of information collection between operations performed on different equipment but the same product,” said Pavlik.
This requires the installation of a company-wide network, software (for example, Allen Bradley’s Factory Talk), laser engravers, and readers. All users must be trained.
“There are specialized turnkey organizations providing service of installing complete systems,” said Pavlik. “Advanced Control Concept Inc. installed and customized the process monitoring system for ASI. Process monitoring and process trend generating tools are essential for better understanding your manufacturing processes and for improving quality.”
Logothetis agreed: “Validation is one of the most important services an automation partner can provide. The documentation serves as a framework for equipment design for all mechanical, electrical and software components of the system and upon machine completion becomes a troubleshooting guide to address any issues that arise during the life cycle of the equipment.”
Using the Good Automated Manufacturing Practice (GAMP)-5 Guide as a basis, Kahle Automation provides custom validation documentation suited for each customer's individual requirements, following a risk-based approach. This includes an easy-to-understand graphical approach to validation, designed to be read and understood by program managers, designers, mechanics and operators alike. This documentation has proven to be an invaluable resource in assessing process and equipment risk during development using input from all customer departments.
The Kahle validation team uses existing customer internal document templates and structure for ease of integration into existing document control, or can deliver a validation package based on GAMP-5 standards. Validation services include development of a quality plan, validation plan, sequence map for all equipment processes and functions, functional requirements specification, and design requirements specifications.
“To ensure the quality of every item that comes off the production line, we perform a comprehensive risk analysis during multiple stages of the project to unearth uncontrolled conditions related to operator safety, machine safety, efficiency, product quality, data integrity, and product user safety,” said Logothetis. “The aim is to reduce risk in the assembly and inspection processes to ensure robust and reliable equipment, as well as enable our customers to achieve and maintain current good manufacturing practice compliance with all relevant regulatory body requirements.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. He can be reached at mark.crawford@charter.net.
According to Noel Taylor, chief technology officer for Sunnyvale, Calif.-based Modified Polymer Components, which manufactures and assembles parts and products for medical device OEMs, the industry is looking for assembly and automation processes that have higher levels of statistical quality.
“Statistical process control is being pushed down to the component-level manufacturer,” said Taylor. “It is common for customers to want fully qualified processes very shortly after proof-of-concept prototypes. In order to accomplish this, we need to have teams working on projects at the very beginning that can invent and optimize in parallel.”
Creating a medical device with plenty of quality at the right price point is always challenging. Most of the innovation that is happening in assembly and automation at present involves finding new ways to improve efficiency and reduce cycle times and still meet increasingly complex design needs. The increase in multiple uses or functions for devices is forcing contract manufacturers and vendors to look at assembly and automation with a more creative perspective. For example, balloons are now being used as platforms for drug delivery and targeted tissue ablation, which has brought a host of new manufacturability and assembly challenges to the forefront: How can the drug or electronics be attached to the balloon effectively, without doubling the cost of the balloon? How does the manufacturer ensure the majority of the drug, in the right dose over the right time frame, gets to the targeted location? What innovation is required to be sure the electronics stay on the balloon when the balloon is deflated?
These requirements often turn the manufacturer/assembler into the problem solver.
Interface Catheter Solutions, a Laguna Niguel, Calif.-based medical balloon developer and contract manufacturer, helped solve this assembly challenge by modifying the balloon surface.
“We discovered that balloon surface modification improves the quality and cost of drug/electronics adherence and will likely play an important role as these new markets evolve with new drugs, variable drug dosing and more elaborate sensing and ablating flexible electronics,” said Mark Geiger, vice president of sales and marketing Interface Catheter Solutions.
A rough or textured surface creates a more effective surface area for bonding. Currently, several steps are involved in attaching a drug to a balloon with the correct dose and consistency. A textured surface adds even more value because it may eliminate one or more of those steps, improving drug-eluting balloon quality and reducing cost.
“We think this will also be true with mounting electronics to balloons, which is the current trend in treating atrial fibrillation and high blood pressure with renal denervation,” Geiger continued. “The goal, of course, is inflating the balloon to deliver therapy, and deflating it, without leaving the electronics behind when it is removed.”
Another example from the balloon market is the balloon shaft weld for higher-pressure balloons with lower profiles and smaller-diameter shaft tubes. Traditional thermal or laser welding or adhesives do not provide the level of customization required to meet the requirements for these new designs.
“Interface determined that thermal compression bonding, with custom welding dies for a specific balloon catheter shaft material and diameter, create a uniform, robust weld that won’t leak because the two materials are bonded to each other without deforming the inner lumens of the tube,” said Geiger. “This process also increases the rated pressure of the balloon catheter system.”
Kahle Automation, a Morristown, N.J.-based designer and builder of automation systems for the medical device industry, is another company that develops new technology when it needs it.
“As a custom automation company, if existing solutions for even the simplest operation do not meet our requirements and standards for quality and consistency, or may not be able to meet the rigorous functional conditions required for high-speed automation, we will develop our own technology,” said Julie Logothetis, president of Kahle Automation.
A recent example is Kahle Automation’s tip-forming technology, which was developed to meet customer quality and output requirements for high-speed, consistent tip-forming for various materials for a line of catheter assembly machines.
“Our most recent innovation is a fluid-dispensing system that allows us to dispense various fluids with a wide range of viscosities to a tolerance of +/- 5 microliters,” said Logothetis.
Modular Automation
Many contract manufacturers lean toward semi-automated assembly processes that are nimble and scalable so they can work with rapidly changing OEM demands and get products to market faster.Smaller product lots and shorter product life cycles also keep full automation at low priority because of the time involved to validate the larger-scale process, as well as the high cost in machinery and time.
“Using modular automated assembly equipment is a good way to reduce the overall cost of production,” said Rudolf Pavlik, product development manager for ASI, a Millersburg, Pa.-based contract manufacturer of OEM healthcare products and single-use systems.“Demco Automation’s Wedge system, for example, is highly customizable and a relatively inexpensive way to automate lower-volume projects.”
This system consists of either tooled or untooled stations with distributed controls that plug into a base chassis (bench-top, rotary dial, inline and walking beam models) for immediate start up. Each station is a tooling plate that is equipped with an on-board controls box that includes a controller, wiring, valve manifold and input blocks; they also come with pinning, tapping and key holes that align with docking stations on the chassis platform. Stations can operate alone as a tabletop station or plug into the base chassis to operate in a manual, semi-automatic or automatic mode. According to Pavlik, Demco’s proprietary Windows-based PLC programming (programmable logic controller; primarily used to control machinery) is easy to operate; stations are programmed by simply checking boxes on a PC screen for a sequence of designated inputs and outputs.
Another cost-effective approach is using modular robotic or (X) (Y) programmable work stations that serve as multifunctional, positive positioning systems.
“Interchangeable tooling cassettes can be loaded to the work cell incorporating many different assembly methods, like heat staking, heat insertion, ultrasonic, etc.,” added Colin Drewek, account manager for PTI Engineered Plastics, a Macomb, Mich.-based provider of plastic injection molding and assembly services. “This also provides a cost-effective assembly alternative for low- to medium-volume applications.”
Automation also can save money at the end of a production run by inspecting the finished product. This eliminates human errors, speeds throughput and validates the process.
In the balloon world, for example, the time spent manually inspecting balloons, and the somewhat subjective reporting that results, contribute significantly to the overall high cost of balloons. Structural flaws that can lead to balloon failure often are difficult to identify, categorize, and measure, especially using the manual contact measurement and inspection tools that are still considered the standard today. Such tools also are inferior for determining precise critical dimensions such as interior diameter, wall thickness, and concentricity. This all leads to higher costs, more scrap, increased product returns, low yields, and more recalled product.
“Using an automated, computerized balloon visual inspection can provide full dimensional and defect measurement and recording in under a minute—reducing the cycle time of inspection by about 30 percent,” said Geiger. “Our custom software, three years in the making, is designed to detect and measure flaws like fisheyes, gels, crow’s feet and strain lines—the defects that balloon manufacturers care about the most.”
Keep It Clean!
Assembly and automation perform most efficiently (and therefore-cost effectively) in a modern, clean manufacturing environment with environmental controls to minimize the ambient particulates.
“The environment controls provided by the manufacturer are a good place to start when designing an automation system,” said Ben Webster, automation validation manager for ATC Automation, a Cookesville, Tenn.-based that provides assembly and testing solutions for medical device companies.
For example, laminar air flow is a big help in controlling particulate matter. If laminar air flow is present, the automation vendor can design the equipment to utilize this feature to help control unwanted particulates.If a laminar flow does not exist, other techniques can be utilized such as enclosures.
“At this point, every influence of air flow should be examined to understand each mechanism that moves air within the automated equipment,” said Webster.“A good example of this is a robot in an automation system that began to experience erratic failures.It was determined that the cooling fan was pulling the conductive dust from the assembly in and exposing the control board, causing shorts in the circuit.”
According to Bob Rice, ATC Automation’s applications team leader, “clean-ability” is another area that is critical in the designing of automation systems. “Machines should be designed to reduce pockets or crevices that can harbor foreign substances or even stray piece parts,” he said.
Plastic or stainless steel shielding can make a machine easy to clean.If parts or materials exit the normal product flow, they can be easily identified and removed.Every precaution should be made to avoid contaminating finished and approved parts and materials; using advanced vision systems can optimize cleanliness in these areas.
“Nothing is more important than having experience with these issues when designing automation equipment,” said Rice.“Trying to correct cleanliness errors once the equipment is on the production floor is too costly.Therefore, a device manufacturer should seek a reputable automation vendor that can discuss these issues during the design phase of a project, not during the installation phase.”
For certain products that are especially sensitive to contamination, manufacturing in a clean room is the preferred solution. For example, Vesta, a provider of silicone and thermoplastic contract manufacturing services for medical device manufacturers, recently constructed a new, Class 10,000 clean room at its silicone manufacturing facility in Franklin, Wis.
“While the majority of our medical device customers’ requirements can be supported in our Class 100,000 controlled room environment,” said Jim Fitzgerald, executive vice president of sales and marketing for Vesta, “our certified Class 10,000 clean room provides an environment with higher particulate air filtration to meet very strict requirements for those customers who require it for compliance with their product manufacturing specifications.”
The Class 10,000 clean room features a HEPA filtration system, temperature and humidity controls and requires strict gowning procedures. Manufacturing processes that will be carried out include silicone molding, silicone extrusion, secondary operations and sub-assembly and packaging processes that require a maximum of 10,000 particles (0.5 microns or larger) per cubic foot of air.
Designing an Assembly System
Assembly and automation options should be considered at the very beginning of the design process. The device or part should be designed with assembly in mind—if the parts do not join together easily, automation will not be as reliable and more completed assemblies will be rejected, adding time and cost to the production runs.
“The fit of each part to another is critical for successful automation,” stated Ron Szostek, vice president of engineering for Concep Machine, a Northbrook, Ill.-based company that designs and manufacturers special-purpose machinery and factory automation systems for medical device assembly and test applications. “It is very important to consider designing in features that help guide the parts together—lands, chamfers and assembly guides go a long way in supporting the assembly process. It also helps for designers to consider parts for assembly in a manner that allows the part to go together without special tooling considerations.”
Szostek recommends prototyping high-risk processes. Sometime during product design, or at the beginning of the development of a machine user-requirement specification (URS), vendors may identify areas of the assembly process that demonstrate a high risk or require a new concept for tooling.
“In these instances, the development of a prototype can be used to confirm the process or tooling approach,” said Szostek. “These prototypes are most helpful if the part samples of the assembly components are in a stable design stage. Developing the production tooling at this stage with a simple prototype can confirm key data, such as the feasibility of the process, as well as whether it will work within a cycle time window, generate any particulate or damage the assembly.”
The next step after obtaining feedback on the assembly processes is making some fundamental choices regarding the type of machine that is desired.
“Feed rate becomes an important factor at this stage of the development,” said Szostek. “For example, the use of pneumatics for actuations in the machine is a good choice; however, they are limited to speeds that do not cause premature wear of the devices. Cam-actuated processes, on the other hand, will provide much higher machine speeds but require a higher investment than pneumatics do.”
The URS is an important guide for the automation project because it enables suppliers to provide accurate and complete proposals for the equipment.
“The manner in which customers write the URS varies widely; some are very detailed while others are intentionally vague and open to interpretation,” said Szostek. “In either case, the ‘must haves’ for the machine project must be clearly defined to ensure project success.”
Conduct a comprehensive process failure modes and effects analysis (PFMEA). A complete and detailed PFMEA provides invaluable information about the machine process. High-risk priority numbers are a strong indication that a process is not going to be robust in a machine, or that it will be a high-maintenance area once the machine enters production. Modification of the process at this phase of the project can be a low-cost, low-risk solution for the automation. Making these changes early in the engineering design of the machine also lessens the cost impact to the overall project.
Finally, Szostek said, develop a project plan and monitor it often. The project plan should contain key data points that relate to the project schedule and show both supplier and customer key inputs for the project. Once the project plan has been developed, it needs to be reviewed and maintained as a living document. It should be reviewed whenever the project team has a major meeting or review event.
“Adjustments need to be made that show both the original base-line and real-time adjustments that have been implemented to accommodate changes in the project schedule,” said Szostek. “This approach becomes vitally important during the de-bug phase of machine development. De-bug is the phase when unexpected time may need to be allocated in the schedule to solve a problem on the machine that could not be foreseen and is not apparent until the system is under power and beginning to cycle.”
Process Validation
Automation is being used more for monitoring, trending and archiving manufacturing process parameters. Validated process parameters can then be stored in recipe files, recalled at point of use by part number and continuously compared with in-process parameters provide immediate feedback for improved understanding of the process, stability and robustness of the parameters affecting product quality.
“Product testing outcome as a part of the assembly has additional meaning for a customer who is a recipient of the data,” said Pavlik. “Fully integrated validation process monitoring and archiving provide detailed information to customers during audits, or as a part of the documentation shipped with a finished product.”
In addition to recording and archiving manufacturing process parameters, ASI also is integrating product serialization.
“The use of QR (quick response) codes provides continuity of information collection between operations performed on different equipment but the same product,” said Pavlik.
This requires the installation of a company-wide network, software (for example, Allen Bradley’s Factory Talk), laser engravers, and readers. All users must be trained.
“There are specialized turnkey organizations providing service of installing complete systems,” said Pavlik. “Advanced Control Concept Inc. installed and customized the process monitoring system for ASI. Process monitoring and process trend generating tools are essential for better understanding your manufacturing processes and for improving quality.”
Logothetis agreed: “Validation is one of the most important services an automation partner can provide. The documentation serves as a framework for equipment design for all mechanical, electrical and software components of the system and upon machine completion becomes a troubleshooting guide to address any issues that arise during the life cycle of the equipment.”
Using the Good Automated Manufacturing Practice (GAMP)-5 Guide as a basis, Kahle Automation provides custom validation documentation suited for each customer's individual requirements, following a risk-based approach. This includes an easy-to-understand graphical approach to validation, designed to be read and understood by program managers, designers, mechanics and operators alike. This documentation has proven to be an invaluable resource in assessing process and equipment risk during development using input from all customer departments.
The Kahle validation team uses existing customer internal document templates and structure for ease of integration into existing document control, or can deliver a validation package based on GAMP-5 standards. Validation services include development of a quality plan, validation plan, sequence map for all equipment processes and functions, functional requirements specification, and design requirements specifications.
“To ensure the quality of every item that comes off the production line, we perform a comprehensive risk analysis during multiple stages of the project to unearth uncontrolled conditions related to operator safety, machine safety, efficiency, product quality, data integrity, and product user safety,” said Logothetis. “The aim is to reduce risk in the assembly and inspection processes to ensure robust and reliable equipment, as well as enable our customers to achieve and maintain current good manufacturing practice compliance with all relevant regulatory body requirements.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. He can be reached at mark.crawford@charter.net.