Jim Stommen , Contributing Writer05.10.12
When a company’s name is stamped on a product, that name and the product’s quality become inseparable—whether that name is Ford Motor Company, Hoover, Medtronic Inc. or Toshiba. And while their names may not go on the final product, it’s equally important to the companies that supply parts to those products. Maybe even more so.
With original equipment manufacturers pushing hard to shrink their supplier lists, there seems to be greater emphasis on quality at the contract supplier level than ever before, even with the same OEMs also constantly on the lookout for ways to cut their manufacturing costs. Industry professionals representing varied stages along the manufacturing chain talked with Medical Product Outsourcing about the role of quality in these cost-cutting, fewer-are-better times.
Their take? Yes indeed, quality is ever more important as calls are going out to fewer and fewer would-be suppliers, but that’s not the only reason for that emphasis.
Denise Dion, a consultant with EduQuest Inc., a Hyattsville, Md.-based consulting firm focused on regulatory compliance issues in the medical field, said that OEMs “are trying to shrink their supplier lists because these companies are required to qualify and monitor their suppliers, so that’s a much easier thing to do with a smaller list of suppliers.” And, she added, “What a supplier needs to do is to be able to help them out and really put the emphasis on quality just as the OEM is doing.”
While acknowledging that pressures to cut costs are part of the business life for contract suppliers, she cautioned that “cutting cost at the expense of quality in the short term may help your bottom line but in the long run, you’re going to end up losing customers.”
Nader Fathi, general manager, Supply Chain Quality, at Camstar Systems Inc., a Charlotte, N.C.-based provider of quality management and manufacturing execution systems for numerous industries, said that with pressures to cut costs being part of the fabric of doing business, companies “are realizing that they need to not only cut costs and price, but also to make sure that the quality doesn’t fade away.”
Kari Miller, senior director of Industry Solutions and Product Management at Pilgrim Software Inc. in Tampa, Fla., said “there are two main, related reasons for the greater emphasis on quality. One is the FDA (U.S. Food and Drug Administration) or other regulatory agencies, and the second is risk.” She noted that the FDA is more sharply focused on quality than ever before, particularly because of lessons learned from high-profile incidents such as tainted Heparin, which was caused by supply chain quality problems. “The FDA and other regulatory bodies have turned their attention to the extended supply chain because experience shows there is great risk there,” Miller said.
“Outsourcing is a growing trend,” she said. “When you combine this trend, and the fact that the extended supply chains are further away from the FDA’s reach, with recent case studies that have clearly revealed it was the extended supply chain that went awry; the agency is now really paying attention.”
Miller said her company is “urging customers to look at quality differently. Many organizations see quality as a cost burden, but we’re counseling that the cost of bad quality in charge-backs or penalties or product shortages is even higher. Quality is an integral part of being able to manufacture and execute these days and that starts with the material coming in the front door.”
Timothy Lozier, marketing manager for ETQ Inc., a provider of quality management and compliance software solutions based in Farmingdale, N.Y., said he thinks that the emphasis on quality is a reflection of the needs that OEMs face with what he characterized as “today’s rapid product lifecycles.”
To do so, he said, medical device firms are “emphasizing quality more than ever, both within the company and down the supply chain.”
He cautioned that suppliers “need to weigh the cost of poor quality versus time to market. With today’s rapid product lifecycles, getting products out the door is making it harder to benchmark quality, but the cost of poor quality needs to be considered. With brand owners becoming increasingly stringent on selecting suppliers with the best quality and least risk, it becomes imperative that suppliers take steps to ensure that their products are of the highest quality and pose the least risk to the brand owner.”
Understanding the Quality Level
Dion, a former FDA investigator whose consulting work delves deeply into the thicket of regulatory compliance, said that supplier lists are being shrunk because of new requirements for monitoring companies in the supply chain.
“It makes it easier for them to manage them and they’re also able to share some of the data with their sister organizations and companies.” From the supplier’s perspective, she said, “OEMs need to be able to trust that the supplier is going to be able to meet all those quality expectations over and over again, because they can’t afford to have to keep going out to find new suppliers. If it’s a PMA (premarket approve application) product, to make a change to a supplier can cause the OEM to have to submit a new submission to the agency to get permission to make that change, and that’s a costly thing to do.”
She said the processes that suppliers need to follow to ensure the levels of quality they need to achieve to remain a preferred supplier “really depends on what you’re supplying. If you’re supplying nuts, bolts and screws or some sort of material, you may only to need to comply with something like ISO 9000. The bigger the part of the product you’re responsible for, the more you need to think about complying with stricter standards or with FDA regulations. It may just be helpful to be meeting those higher requirements so that you can show you have greater control over your processes.”
Process validation is important to the overall picture because the process can have an impact on whether the product meets quality expectations, but also whether it meets the specifications for the final product itself. Even as a supplier, to change a sub-supplier, it needs to have good quality management, Dion said.
Saying that Good Documentation Practices go hand-in-glove with Good Manufacturing Practices, Dion cited requirements that companies “document what you’re going to do and then document what you did to prove you actually did what you set out to do.”
More Onus on the Importer
Another consultant, Alan Schwartz, related the quality issue to imported goods and materials, including those from China, one of his firm’s areas of focus. Schwartz is a principal in MDI Consultants Inc., a quality assurance/regulatory compliance consulting firm headquartered in Great Neck, N.Y.
He noted that there have been a lot of quality issues concerning imported medical devices—particularly those from China.
“A lot of companies are having quality-related problems, and the FDA is trying to address these problems via the importer since going to the foreign manufacturer is too time-consuming and costly,” Schwartz told MPO.
He noted that with the FDA reaching further down the supply chain, “that is putting a lot more onus on the importers, who in turn are having a more difficult time getting their suppliers to support their regulatory issues. The FDA feels that pushing the importer to control the quality of the devices they import is one way to control the manufacturer without auditing those suppliers. It just puts a lot more emphasis on OEMs making sure their suppliers are in QSR (quality systems regulations) compliance and are committed to ‘real’ quality.”
Because the FDA doesn’t have the resources to inspect all of the overseas suppliers, he said many U.S.-based OEMs are performing more on-site QSR audits and reviewing their quality systems and commitment to quality “besides the ability to supply and of course, the price. The selection process is becoming much tighter to find companies that would fit their requirements.”
Those audits tend to be more extensive than ever before.
“Most of the old audits were just to see if you could make the product, but now they’re keying into their design control, product testing and CAPA (corrective and protective actions) systems in assuring full QSR compliance,” Schwartz said.
Greater Emphasis on Quality
Pilgrim Software’s Miller cited six steps that suppliers have to follow for their quality programs, crediting them to former FDA chief operating officer Steven Niedelman, now a noted quality/regulatory compliance consultant.
“One is an initial supplier quality audit, the next is contractual control with supplier agreements, the third is risk management classifications for that supplier, the fourth is risk-based auditing, the fifth is maintaining supplier data—it’s really important to maintain that data—and last but not least is to have corrective action plans,” Miller said, adding that “even though you might be getting it from China and China may be getting it from somewhere else, it’s the responsibility of the OEM to establish proper quality controls and to provide proper evidence for products and services obtained from those suppliers. Because of this, proper assessment of risk has become really critical in the supply chain.”
But risk plays an even bigger role than just regulatory compliance.
“When you consider the fact that you have fewer suppliers to go to, risk increases. If you don’t have quality material coming from your suppliers, you have fewer options to turn to for replacement of it,” she said.
Companies can’t afford poor quality, Miller added.
“If you don’t have good quality, that lack of quality can be even more costly than maintaining systems, personnel and doing audits, because it costs money to scrap or rework material, lines shut down, you don’t have what you need, then you have freight expediting costs, and recalls— let’s not even start talking about how much those cost. Add in penalties if you fail an audit: They’re all very costly consequences of poor quality,” she said.
Miller said suppliers face three major issues they’re always going to be evaluated on when dealing with an OEM customer that is providing FDA-regulated products—quality, productivity and delivery.
“Suppliers have to be efficient, they have to deliver things on time, and it has to be a quality delivery,” she said. “And in particular, contract manufacturers/suppliers have to make sure they keep proper documentation.”
So standard operating procedures are critical.
“Suppliers have to make sure that all their processes are validated, and that they have quality systems in place for things like complaint handling, non-conformance, root cause analysis and CAPAs, product risk management, design change control—the list goes on,” she said. “We could also talk about traceability, document accessibility, document retention, accessibility, etc. All of these things are going to help suppliers and contractors get to that preferred supplier status.”
But maintaining a high level performance is critical to retaining customers, who have sharply
decreased tolerance for errors.
“If you are a preferred supplier, you have to do your best to maintain that, because if you slip up even once, you can bet the OEM will be off certifying a different supplier,” Miller cautioned.
To that end, Deborah Kacera, industry solutions director at Pilgrim, added: “A lot of times when I’m talking with contract manufacturers, what I’m seeing that they’re doing is becoming compliant to a quality standard, whether that is ISO:13485 or ISO:9001. They understand that even though they’re not held to it, they feel that becomes a differentiator for them to even be looked at by the major-tier medical device or pharmaceutical manufacturers. Many of them understand that they have to have a quality system in place right off the bat.”
Kacera said that in such a scenario, quality systems become the “license” to even enter the fray to make the list of candidates.
“And if contract manufacturers really want to enter this game, they’ll start looking at collaborative tools as well,” she said. “Those manufacturers that can collaborate in terms of change management from design throughout the manufacturing cycle will definitely start getting first consideration from OEMs.”
From the perspective of a supplier of quality systems, Miller said that since cost-cutting initiatives aren’t going to go away anytime soon (or ever), companies must use the quality data they are consistently generating to improve performance.
“They need to be set up so that all this data they’re gathering on quality gets turned into information that is actionable; then you can position quality as a benefit to an organization, not just a cost,” she said.
Quality as a Differentiator
Camstar’s Fathi agreed that quality is more important than ever before because the FDA “is all over these companies.” He cited two particular factors, one being that “thanks to social media, bad news travels really quickly, and company owners and managers are very concerned about bad news getting on the Web.”
Secondly, we live in a very customer-driven market.
“There’s great competition—companies are trying to get to the market faster, better, cheaper. And quality has become a differentiator,” he said. “Before it was a checkmark, but now it is being used as a differentiator.”
Chris Parsons, Camstar’s senior director of marketing communications, said supplier controls are a “hot button” with the FDA, particularly supplier change controls, driven by a doubling of supply chain-related field actions over the past five years. He said that the sheer numbers of suppliers that medical device OEMs have is “a huge challenge” and the rapid pace of globalization adds both complexity and risk.
“The brand owner is responsible in all cases—if something goes wrong with a device, it’s the brand owner’s responsibility,” Parsons said. “Device companies try to lock everything down in a partnership agreement to get traceability, to get required documentation, but in reality what they do is audit those suppliers. It’s up to the supplier to provide data, which is generally in paper or Excel spreadsheet form and not proactive as in correcting issues or defects at the source, which contributes to the increasing number of field actions and recalls.”
Fathi noted that medical companies use incoming inspection groups or quality control (QC) groups.
“When the parts come to them, they do incoming inspection. What we are hoping is to inspect at the source, push this back to the supplier so that if anything does not meet the specifications, it raises a flag,” he said. “That also would let the OEM reduce the QC headcount.”
He said that one of the many things the FDA requires “is to make sure the process is followed correctly. So again, what we see is that next-generation automation systems are trying to get rid of paper and make this electronic so it’s easier to manage. And the new systems are now smart enough to raise a flag when something is not right. The systems are getting smarter by raising a flag and stopping the flow.”
Keeping Pace with Lifecycle
EtQ’s Lozier said the whole concept of quality is evolving to keep pace with the product lifecycle. New methods are being employed to ensure quality at all stages of the product lifecycle. Automated systems are being employed to help streamline quality processes, and new methods are being employed to ensure supplier quality, he said.
Lozier said that supplier risk “is now a large part of an organization’s method for choosing who to do business with, and in order to ensure complete transparency and compliance, suppliers must demonstrate their quality more than ever before, especially in regulated industries.”
He added that risk management is a growing method for benchmarking quality, and this has extended to the supply chain.
“Suppliers are now a part of the brand owner’s quality process, and with technology, they are able to participate in the process,” he said. “Quality management systems have evolved beyond traditional silos, and organizations no longer operate in a vacuum of business systems. Systems are integrated—and quality is a central part of this orchestration of business systems.”
In many organizations, according to Lozier, this is evolving into a “quality hub” of sorts—one where the quality management system is reaching into all aspects of the business and connecting the various business systems with a common theme—“quality and compliance, from start to finish.”
He said this is especially true in the supply chain, so that suppliers need to focus on their quality processes and align themselves with the brand owner’s common processes. Inspections, testing, and documented procedures need to be well-aligned so that when the materials leave the supplier’s dock, they have followed similar standards of quality as when it reaches the brand owner’s dock.
“On the other side, we are seeing suppliers becoming increasingly a part of the brand owner’s corrective action process, participating directly with the systems that are executing the CAPA,” he said.
“This has reduced the lag time and communication barriers of correcting systemic events in the supply chain, and creates a much more seamless collaboration on quality events. Much like you see a bill of materials for production, you are starting to see organizations adopt a ‘Bill of Compliance’—one that a supplier can follow to ensure that compliance processes are met on their operations that align with the brand owner’s compliance standards.”
A Relationship Transformed
Carola Bousserghine, quality assurance manager at Polymer Solutions Inc., a polymer testing lab/product development firm located in Blacksburg, Va., said that one of the reflections of the new emphasis on quality is that for most of the firm’s would-be customers, “the first thing they want to see is that we’re compliant with ISO:17025 and that we’re FDA-registered and GMP-compliant. Most of them are dealing with medical devices or pharmaceuticals, and they have to comply with those regulations for themselves, so when they are contacting suppliers it’s critical for them to use suppliers that have the systems in place to meet those quality needs.”
Cynthia Rancourt, director of Business Operations for the company, added that such new customers “come in and they audit us—we get an average of one or two audits a month. They want us to be up to the standards of a manufacturing plant. Sometimes there are differences in expectations, and that can be a challenge for us because we are not a manufacturer, so we have become pretty adept at understanding what they really are looking for.”
Rancourt said the increase in the manpower now required for audits has been phenomenal.
“We often need to have three of us in an audit session, and additional people to run and get what they need,” she said.
Bousserghine said the key to being able to do these audits and maintain these systems is having compliance software, “which in the FDA world has to be a validated system,” she said. “This is absolutely critical to maintain all of the equipment, the qualification statuses, the change control and maintaining the document system. From the auditing standpoint, it’s critical to have a validated system in place.”
Changing demands mean more than just the normal challenges of doing business.
As Rancourt noted, “Our business model is to make money from laboratory testing, but in order to do the laboratory testing we have to qualify the equipment, we have to validate software. If we develop a method for a client, then we have to validate that method. So consequently our business model is moving a little more in the direction of going after medical device companies and pharmaceutical companies, as they understand the high cost of quality in order to get their work accepted by the FDA.”
Keying on Management Review
Ian McDonald, RA/QA director at Coastal Life Technologies Inc. of San Antonio, Texas, cited the importance of management review processes in analyzing opportunities for improvement.
“The various quality system processes generate data that should be consistently mined for opportunities for improvement,” he said.
Coastal Life provides manufacturing solutions to device manufacturers, with an emphasis on assembly, packaging and distribution of single-use surgical devices.
“We use the management review process as the home for our various routine analyses, and as the vehicle for communication of the results,” McDonald said. He added that management review is not something that is isolated to quarterly, semi-annual, or annual meetings. “It is a living process with more routine communication of results.”
He said that process validation is highly important to the overall effort.
“A subpar process can significantly cut into manufacturing efficiency, raise scrap rates, and in turn erode margins, but a good process validation program helps establish and maintain proper efficiency in material usage and manufacturing,” McDonald said.
Part of dealing with quality issues in the manufacturing process means following good documentation practices.
“It is difficult to analyze a quality issue in the manufacturing process if documentation is shoddy,” he said.
Jim Stommen, retired editor of industry publication Medical Device Daily, is a freelance writer focusing on the medical product sector.
With original equipment manufacturers pushing hard to shrink their supplier lists, there seems to be greater emphasis on quality at the contract supplier level than ever before, even with the same OEMs also constantly on the lookout for ways to cut their manufacturing costs. Industry professionals representing varied stages along the manufacturing chain talked with Medical Product Outsourcing about the role of quality in these cost-cutting, fewer-are-better times.
Their take? Yes indeed, quality is ever more important as calls are going out to fewer and fewer would-be suppliers, but that’s not the only reason for that emphasis.
Denise Dion, a consultant with EduQuest Inc., a Hyattsville, Md.-based consulting firm focused on regulatory compliance issues in the medical field, said that OEMs “are trying to shrink their supplier lists because these companies are required to qualify and monitor their suppliers, so that’s a much easier thing to do with a smaller list of suppliers.” And, she added, “What a supplier needs to do is to be able to help them out and really put the emphasis on quality just as the OEM is doing.”
While acknowledging that pressures to cut costs are part of the business life for contract suppliers, she cautioned that “cutting cost at the expense of quality in the short term may help your bottom line but in the long run, you’re going to end up losing customers.”
Nader Fathi, general manager, Supply Chain Quality, at Camstar Systems Inc., a Charlotte, N.C.-based provider of quality management and manufacturing execution systems for numerous industries, said that with pressures to cut costs being part of the fabric of doing business, companies “are realizing that they need to not only cut costs and price, but also to make sure that the quality doesn’t fade away.”
Kari Miller, senior director of Industry Solutions and Product Management at Pilgrim Software Inc. in Tampa, Fla., said “there are two main, related reasons for the greater emphasis on quality. One is the FDA (U.S. Food and Drug Administration) or other regulatory agencies, and the second is risk.” She noted that the FDA is more sharply focused on quality than ever before, particularly because of lessons learned from high-profile incidents such as tainted Heparin, which was caused by supply chain quality problems. “The FDA and other regulatory bodies have turned their attention to the extended supply chain because experience shows there is great risk there,” Miller said.
“Outsourcing is a growing trend,” she said. “When you combine this trend, and the fact that the extended supply chains are further away from the FDA’s reach, with recent case studies that have clearly revealed it was the extended supply chain that went awry; the agency is now really paying attention.”
Miller said her company is “urging customers to look at quality differently. Many organizations see quality as a cost burden, but we’re counseling that the cost of bad quality in charge-backs or penalties or product shortages is even higher. Quality is an integral part of being able to manufacture and execute these days and that starts with the material coming in the front door.”
Timothy Lozier, marketing manager for ETQ Inc., a provider of quality management and compliance software solutions based in Farmingdale, N.Y., said he thinks that the emphasis on quality is a reflection of the needs that OEMs face with what he characterized as “today’s rapid product lifecycles.”
To do so, he said, medical device firms are “emphasizing quality more than ever, both within the company and down the supply chain.”
He cautioned that suppliers “need to weigh the cost of poor quality versus time to market. With today’s rapid product lifecycles, getting products out the door is making it harder to benchmark quality, but the cost of poor quality needs to be considered. With brand owners becoming increasingly stringent on selecting suppliers with the best quality and least risk, it becomes imperative that suppliers take steps to ensure that their products are of the highest quality and pose the least risk to the brand owner.”
Understanding the Quality Level
Dion, a former FDA investigator whose consulting work delves deeply into the thicket of regulatory compliance, said that supplier lists are being shrunk because of new requirements for monitoring companies in the supply chain.
“It makes it easier for them to manage them and they’re also able to share some of the data with their sister organizations and companies.” From the supplier’s perspective, she said, “OEMs need to be able to trust that the supplier is going to be able to meet all those quality expectations over and over again, because they can’t afford to have to keep going out to find new suppliers. If it’s a PMA (premarket approve application) product, to make a change to a supplier can cause the OEM to have to submit a new submission to the agency to get permission to make that change, and that’s a costly thing to do.”
She said the processes that suppliers need to follow to ensure the levels of quality they need to achieve to remain a preferred supplier “really depends on what you’re supplying. If you’re supplying nuts, bolts and screws or some sort of material, you may only to need to comply with something like ISO 9000. The bigger the part of the product you’re responsible for, the more you need to think about complying with stricter standards or with FDA regulations. It may just be helpful to be meeting those higher requirements so that you can show you have greater control over your processes.”
Process validation is important to the overall picture because the process can have an impact on whether the product meets quality expectations, but also whether it meets the specifications for the final product itself. Even as a supplier, to change a sub-supplier, it needs to have good quality management, Dion said.
Saying that Good Documentation Practices go hand-in-glove with Good Manufacturing Practices, Dion cited requirements that companies “document what you’re going to do and then document what you did to prove you actually did what you set out to do.”
More Onus on the Importer
Another consultant, Alan Schwartz, related the quality issue to imported goods and materials, including those from China, one of his firm’s areas of focus. Schwartz is a principal in MDI Consultants Inc., a quality assurance/regulatory compliance consulting firm headquartered in Great Neck, N.Y.
He noted that there have been a lot of quality issues concerning imported medical devices—particularly those from China.
“A lot of companies are having quality-related problems, and the FDA is trying to address these problems via the importer since going to the foreign manufacturer is too time-consuming and costly,” Schwartz told MPO.
He noted that with the FDA reaching further down the supply chain, “that is putting a lot more onus on the importers, who in turn are having a more difficult time getting their suppliers to support their regulatory issues. The FDA feels that pushing the importer to control the quality of the devices they import is one way to control the manufacturer without auditing those suppliers. It just puts a lot more emphasis on OEMs making sure their suppliers are in QSR (quality systems regulations) compliance and are committed to ‘real’ quality.”
Because the FDA doesn’t have the resources to inspect all of the overseas suppliers, he said many U.S.-based OEMs are performing more on-site QSR audits and reviewing their quality systems and commitment to quality “besides the ability to supply and of course, the price. The selection process is becoming much tighter to find companies that would fit their requirements.”
Those audits tend to be more extensive than ever before.
“Most of the old audits were just to see if you could make the product, but now they’re keying into their design control, product testing and CAPA (corrective and protective actions) systems in assuring full QSR compliance,” Schwartz said.
Greater Emphasis on Quality
Pilgrim Software’s Miller cited six steps that suppliers have to follow for their quality programs, crediting them to former FDA chief operating officer Steven Niedelman, now a noted quality/regulatory compliance consultant.
“One is an initial supplier quality audit, the next is contractual control with supplier agreements, the third is risk management classifications for that supplier, the fourth is risk-based auditing, the fifth is maintaining supplier data—it’s really important to maintain that data—and last but not least is to have corrective action plans,” Miller said, adding that “even though you might be getting it from China and China may be getting it from somewhere else, it’s the responsibility of the OEM to establish proper quality controls and to provide proper evidence for products and services obtained from those suppliers. Because of this, proper assessment of risk has become really critical in the supply chain.”
But risk plays an even bigger role than just regulatory compliance.
“When you consider the fact that you have fewer suppliers to go to, risk increases. If you don’t have quality material coming from your suppliers, you have fewer options to turn to for replacement of it,” she said.
Companies can’t afford poor quality, Miller added.
“If you don’t have good quality, that lack of quality can be even more costly than maintaining systems, personnel and doing audits, because it costs money to scrap or rework material, lines shut down, you don’t have what you need, then you have freight expediting costs, and recalls— let’s not even start talking about how much those cost. Add in penalties if you fail an audit: They’re all very costly consequences of poor quality,” she said.
Miller said suppliers face three major issues they’re always going to be evaluated on when dealing with an OEM customer that is providing FDA-regulated products—quality, productivity and delivery.
“Suppliers have to be efficient, they have to deliver things on time, and it has to be a quality delivery,” she said. “And in particular, contract manufacturers/suppliers have to make sure they keep proper documentation.”
So standard operating procedures are critical.
“Suppliers have to make sure that all their processes are validated, and that they have quality systems in place for things like complaint handling, non-conformance, root cause analysis and CAPAs, product risk management, design change control—the list goes on,” she said. “We could also talk about traceability, document accessibility, document retention, accessibility, etc. All of these things are going to help suppliers and contractors get to that preferred supplier status.”
But maintaining a high level performance is critical to retaining customers, who have sharply
decreased tolerance for errors.
“If you are a preferred supplier, you have to do your best to maintain that, because if you slip up even once, you can bet the OEM will be off certifying a different supplier,” Miller cautioned.
To that end, Deborah Kacera, industry solutions director at Pilgrim, added: “A lot of times when I’m talking with contract manufacturers, what I’m seeing that they’re doing is becoming compliant to a quality standard, whether that is ISO:13485 or ISO:9001. They understand that even though they’re not held to it, they feel that becomes a differentiator for them to even be looked at by the major-tier medical device or pharmaceutical manufacturers. Many of them understand that they have to have a quality system in place right off the bat.”
Kacera said that in such a scenario, quality systems become the “license” to even enter the fray to make the list of candidates.
“And if contract manufacturers really want to enter this game, they’ll start looking at collaborative tools as well,” she said. “Those manufacturers that can collaborate in terms of change management from design throughout the manufacturing cycle will definitely start getting first consideration from OEMs.”
From the perspective of a supplier of quality systems, Miller said that since cost-cutting initiatives aren’t going to go away anytime soon (or ever), companies must use the quality data they are consistently generating to improve performance.
“They need to be set up so that all this data they’re gathering on quality gets turned into information that is actionable; then you can position quality as a benefit to an organization, not just a cost,” she said.
Quality as a Differentiator
Camstar’s Fathi agreed that quality is more important than ever before because the FDA “is all over these companies.” He cited two particular factors, one being that “thanks to social media, bad news travels really quickly, and company owners and managers are very concerned about bad news getting on the Web.”
Secondly, we live in a very customer-driven market.
“There’s great competition—companies are trying to get to the market faster, better, cheaper. And quality has become a differentiator,” he said. “Before it was a checkmark, but now it is being used as a differentiator.”
Chris Parsons, Camstar’s senior director of marketing communications, said supplier controls are a “hot button” with the FDA, particularly supplier change controls, driven by a doubling of supply chain-related field actions over the past five years. He said that the sheer numbers of suppliers that medical device OEMs have is “a huge challenge” and the rapid pace of globalization adds both complexity and risk.
“The brand owner is responsible in all cases—if something goes wrong with a device, it’s the brand owner’s responsibility,” Parsons said. “Device companies try to lock everything down in a partnership agreement to get traceability, to get required documentation, but in reality what they do is audit those suppliers. It’s up to the supplier to provide data, which is generally in paper or Excel spreadsheet form and not proactive as in correcting issues or defects at the source, which contributes to the increasing number of field actions and recalls.”
Fathi noted that medical companies use incoming inspection groups or quality control (QC) groups.
“When the parts come to them, they do incoming inspection. What we are hoping is to inspect at the source, push this back to the supplier so that if anything does not meet the specifications, it raises a flag,” he said. “That also would let the OEM reduce the QC headcount.”
He said that one of the many things the FDA requires “is to make sure the process is followed correctly. So again, what we see is that next-generation automation systems are trying to get rid of paper and make this electronic so it’s easier to manage. And the new systems are now smart enough to raise a flag when something is not right. The systems are getting smarter by raising a flag and stopping the flow.”
Keeping Pace with Lifecycle
EtQ’s Lozier said the whole concept of quality is evolving to keep pace with the product lifecycle. New methods are being employed to ensure quality at all stages of the product lifecycle. Automated systems are being employed to help streamline quality processes, and new methods are being employed to ensure supplier quality, he said.
Lozier said that supplier risk “is now a large part of an organization’s method for choosing who to do business with, and in order to ensure complete transparency and compliance, suppliers must demonstrate their quality more than ever before, especially in regulated industries.”
He added that risk management is a growing method for benchmarking quality, and this has extended to the supply chain.
“Suppliers are now a part of the brand owner’s quality process, and with technology, they are able to participate in the process,” he said. “Quality management systems have evolved beyond traditional silos, and organizations no longer operate in a vacuum of business systems. Systems are integrated—and quality is a central part of this orchestration of business systems.”
In many organizations, according to Lozier, this is evolving into a “quality hub” of sorts—one where the quality management system is reaching into all aspects of the business and connecting the various business systems with a common theme—“quality and compliance, from start to finish.”
He said this is especially true in the supply chain, so that suppliers need to focus on their quality processes and align themselves with the brand owner’s common processes. Inspections, testing, and documented procedures need to be well-aligned so that when the materials leave the supplier’s dock, they have followed similar standards of quality as when it reaches the brand owner’s dock.
“On the other side, we are seeing suppliers becoming increasingly a part of the brand owner’s corrective action process, participating directly with the systems that are executing the CAPA,” he said.
“This has reduced the lag time and communication barriers of correcting systemic events in the supply chain, and creates a much more seamless collaboration on quality events. Much like you see a bill of materials for production, you are starting to see organizations adopt a ‘Bill of Compliance’—one that a supplier can follow to ensure that compliance processes are met on their operations that align with the brand owner’s compliance standards.”
A Relationship Transformed
Carola Bousserghine, quality assurance manager at Polymer Solutions Inc., a polymer testing lab/product development firm located in Blacksburg, Va., said that one of the reflections of the new emphasis on quality is that for most of the firm’s would-be customers, “the first thing they want to see is that we’re compliant with ISO:17025 and that we’re FDA-registered and GMP-compliant. Most of them are dealing with medical devices or pharmaceuticals, and they have to comply with those regulations for themselves, so when they are contacting suppliers it’s critical for them to use suppliers that have the systems in place to meet those quality needs.”
Cynthia Rancourt, director of Business Operations for the company, added that such new customers “come in and they audit us—we get an average of one or two audits a month. They want us to be up to the standards of a manufacturing plant. Sometimes there are differences in expectations, and that can be a challenge for us because we are not a manufacturer, so we have become pretty adept at understanding what they really are looking for.”
Rancourt said the increase in the manpower now required for audits has been phenomenal.
“We often need to have three of us in an audit session, and additional people to run and get what they need,” she said.
Bousserghine said the key to being able to do these audits and maintain these systems is having compliance software, “which in the FDA world has to be a validated system,” she said. “This is absolutely critical to maintain all of the equipment, the qualification statuses, the change control and maintaining the document system. From the auditing standpoint, it’s critical to have a validated system in place.”
Changing demands mean more than just the normal challenges of doing business.
As Rancourt noted, “Our business model is to make money from laboratory testing, but in order to do the laboratory testing we have to qualify the equipment, we have to validate software. If we develop a method for a client, then we have to validate that method. So consequently our business model is moving a little more in the direction of going after medical device companies and pharmaceutical companies, as they understand the high cost of quality in order to get their work accepted by the FDA.”
Keying on Management Review
Ian McDonald, RA/QA director at Coastal Life Technologies Inc. of San Antonio, Texas, cited the importance of management review processes in analyzing opportunities for improvement.
“The various quality system processes generate data that should be consistently mined for opportunities for improvement,” he said.
Coastal Life provides manufacturing solutions to device manufacturers, with an emphasis on assembly, packaging and distribution of single-use surgical devices.
“We use the management review process as the home for our various routine analyses, and as the vehicle for communication of the results,” McDonald said. He added that management review is not something that is isolated to quarterly, semi-annual, or annual meetings. “It is a living process with more routine communication of results.”
He said that process validation is highly important to the overall effort.
“A subpar process can significantly cut into manufacturing efficiency, raise scrap rates, and in turn erode margins, but a good process validation program helps establish and maintain proper efficiency in material usage and manufacturing,” McDonald said.
Part of dealing with quality issues in the manufacturing process means following good documentation practices.
“It is difficult to analyze a quality issue in the manufacturing process if documentation is shoddy,” he said.
Jim Stommen, retired editor of industry publication Medical Device Daily, is a freelance writer focusing on the medical product sector.