MedAccred continues to expand its support for the medical device industry. Described as an “industry-managed supply chain oversight program for critical manufacturing processes,” MedAccred has added new sterile device packaging and plastics mechanical assembly audit processes, added four new subscribers, and accredited many new suppliers within the last year. The program is also entering its second year of partnering with the US Department of Commerce through the Medical Manufacturers MedAccred Accreditation Pathway (MedMMAP) for manufacturers and suppliers seeking accreditation.
Connie Conboy, MedAccred director, shared such progress during panel discussions held at two recent events, MD&M Minneapolis 2019 and MD&M West 2020. During the Minneapolis panel discussion, “Exploring the Connection Between Your Manufacturing Process & Patient Safety,” she explained how the program could help industry address current challenges with recalls as well as with inadequate purchasing controls to deliver improved patient safety.
Conboy said “industry is beginning to embrace” MedAccred’s accreditation program as “a new approach for industry to oversee their suppliers to address vital issues in all the critical manufacturing processes. Now just one FDA 483 could cost the industry from $500,000 to $1 million to address. Purchasing controls is one of the top reasons for a 483.”
Conboy explained that a MedAccred accreditation audit verifies that an accredited supplier has met the following key industry requirements:
- Critical process capability
- Necessary equipment
- Controls (including subtier controls)
- Qualified personnel
- Process validation
MedAccred requires suppliers under consideration for accreditation to have valid ISO quality management system certification. But the MedAccred audit is “very different” from a quality system audit. The MedAccred process audit program “really does a deep dive into the manufacturing process,” Conboy said. “What the industry is learning is that the two types of audits combined, a quality system audit and MedAccred process audit, ensure final product quality. One without the other is not sufficient. A quality system audit alone gives you an excellent foundation but doesn’t give you a deep dive into the manufacturing process.”
Added David Vazquez, BD’s director, quality engineering and supplier quality, during the Minneapolis panel discussion: “It is very different—a QMS audit is broad but shallow. A MedAccred audit is deep in terms of a process area—a mile deep, inch wide, versus an inch deep, mile wide.” (BD became a MedAccred subscriber in 2019.)
MedAccred audits are more in-depth than an ISO audit, but not as expensive, Conboy. They range from a two-day audit for sterilization operations to a three-day audit for plastics injection molding/extrusion to a four-day audit for electronics manufacturing. And MedAccred has just launched a sterile packaging audit.
“Subscribers really make the decisions for the program,” Conboy said. Performance Review Institute (PRI) “administers it, but subscribers manage the program, determine the audit criteria, select the auditors, have full access to audit findings, and determine who is granted a MedAccred accreditation,” she said.
Task groups create the criteria for supplier audits, and suppliers are audited once a year, and after three successful audits, a company could achieve a merit basis and then be audited once every 18 months.
“The prime reason to be a subscriber,” Vazquez later told MD+DI, “is to gain insight into the audits themselves. Also, we have a voice to grant/revoke an accreditation. We collectively and collaboratively start to raise the bar for suppliers to improve product quality and subsequently patient safety.”
During the Minneapolis panel discussion, Ann Sheldon, vice president, global supplier quality, Medtronic, explained that the program “is really about looking at special processes [in which] we can’t detect defects either through receiving inspection or even in manufacturing inline inspection. A lot of times we will see latent failures that are process related and undetectable. So this will go in and look much deeper at a process than we would through any sort of a QMS audit and be able to show the repeatability of the process and the materials we’ll be getting.
“We are continuously asked about the scrutiny and oversight we have for suppliers. We’re not in a position to add resources to have that oversight,” she continued. “We need to look at creative ways like using an accreditation to get further into the process to show FDA and other regulators outside the United States that we have good control and good partnership with our suppliers and that we are driving quality.”
Scott Goolsbey, supplier controls manager, Stryker, echoed the importance of such scrutiny: “We know that these processes have inherent risk and we know that they are critical to patient safety. We know that we can reduce that risk if these processes are being carried out at a very high level.” he added. “So the question is what is the standard? What is the high level? For us, the program answers that question. It sets the standard. . . . Who is operating at a higher level? Our suppliers that are accredited.”
There may also be business benefits for accredited suppliers. Goolsbey told the Minneapolis audience that “MedAccred directly aligns with our corporate mission to make healthcare better. We are starting to make sourcing decisions based on accreditation.” He explained later on that “we’ve already started awarding business based on accreditation and that will just increase in the future.”
Vazquez later agreed, saying that “we are looking at how to build it into our bidding-and-awarding-business process—we do see an advantage for suppliers holding an accreditation.”
Conboy acknowledged that there are a lot of requirements for suppliers today, and asked Sheldon of Medtronic to explain how MedAccred would fit in. “We are all under changing regulations, and we feel the same impact of repeated audits,” Sheldon said. “Where MedAccred comes in fits in more on the performance side. We want to move toward performance-monitoring-based audits. We will always consider risk, but we also do performance management. If we can prove through accreditation that the supplier has better performance in terms of nonconformances coming into our facilities, we can give credit for that and explain to regulators and help them understand where it fits in under purchasing controls that we are under the scrutiny of.”
Addressing many suppliers in the Minneapolis audience, Sheldon later said that “you do business with a lot of us, and I’m sure we don’t do anything the same, so you probably have a lot of conversations with us to drive more standardization. We’re trying to do that for you. . . The industry is trying to land on a standard and that standard includes having a supplier at the table helping us define the standard. . . . I would think that if I were sitting in the suppliers’ chair, this would be a really big advantage. You’ve got all of us at the table—you’re not required to do that on your own. We’ve made the commitment to do that for you. And so consider that as you look at this program.”
There may also be some assistance available. Anthony Cerilli, national director of the MedMMAP program, a federal-private partnership and part of NIST’s Manufacturing Extension Partnership, told MD+DI that MedMMAP “helps suppliers become competitive and grow jobs. I’m trying to keep jobs in the United States and get suppliers accredited to capture new business.” In collaboration with subscribers, the program helps manufacturers become accredited through preassessments that “let companies know what gaps exist and how to close them and prepare for accreditation,” he explained. “A $1 million grant allowed us to develop a program and train staff.”
As mentioned earlier, MedAccred added a new sterile device packaging audit process in 2019. Supporting that initiative, Quality Tech Services LLC (QTS) piloted the packaging audit process and became the first company to achieve that accreditation in packaging system assembly/filling and sealing of trays.
MedAccred has added four new subscribers within the last year (Bausch Health, BD, Bayer, and Roche Diagnostics), bringing the total up to 10. The first subscribers to MedAccred in 2014 were Philips, Johnson & Johnson, Stryker, and others that have joined since then include Baxter, Boston Scientific, and Medtronic. The first supplier accreditation was awarded in 2015 to Solar Atmospheres, and just a few of the many accredited suppliers since are Bodycote, Kaysun Corp., BMP Medical, Flex, Elytone Electronic, Benchmark Electronics, Hoffer Plastics (the most recently accredited supplier), PTI Engineered Plastics, PTA Plastics, Plexus, QTS, Steri-Tek, Sterigenics, and Sanmina.
Flex is the first supplier to achieve “merit status” at six global locations, which means that it will now be audited every 18 months instead of 12 at all six manufacturing sites. The company manufactures printed circuit board assemblies for medical device applications.
Commenting on Hoffer Plastics MedAccred accreditation as a certified injection molder, Alex Hoffer, chief revenue officer of Hoffer Plastics, said in a statement: “This marks an important milestone in Hoffer Plastics’ history of earned credibility. Receiving MedAccred certification from PRI is a testament to our tradition of commitment to maintaining best-in-class status in plastics injection molding. We know that in the end, customers are looking for peace of mind though product safety, quality, and consistency that a trusted, capable, accredited partner can bring. We are proud to be recognized as an integral part of the trust in that process.”