FDANews
The QMN Weekly Bulletin

Devicemakers Forge Program to Accredit Global Suppliers

July 24, 2015

As global outsourcing has made managing supply chains more difficult, a group of 12 devicemakers has taken matters into its own hands to develop a supplier accreditation program to ensure quality and to be a step ahead of FDA inspectors.

The goal of the program, called MedAccred, is to qualify each of the critical processes in the supply chain. To get there, the devicemakers are working together to set standards via consensus for those processes and to devise auditing checklists for their suppliers.

The group is developing audit criteria for five critical areas first: electronic circuits (PCBA), cables and harnesses, heat treating, sterilization and welding. The manufacturers that make devices from these areas are participating in task forces that manage each particular process area.

Different suppliers will have different checklists depending on the technology and type of commodity, and the critical control points will be different for each area.

Audits are conducted annually, and the Performance Review Institute administers the program and handles nonconformances with suppliers to make sure corrective and preventive actions are taken. If there are significant findings uncovered during an audit, all companies that use that supplier will be notified and appropriate action evaluated. PRI also manages a database of supplier audits, which is publicly available to devicemakers that are MedAccred subscribers, said PRI COO Joe Pinto.

Subscribers are original equipment manufacturers and pay $90,000 to join. The price drops to $60,000 the second year and will drop more as more manufacturers subscribe. Suppliers pay for the audit and accreditation.

Manufacturer Experience

Philips HealthTech was one of the first device manufacturers to subscribe to the MedAccred program, along with Johnson & Johnson’s Depuy and Stryker, said Ravi Nabar, Philips’ senior director of Supplier Quality Management. He has been active with the MedAccred program since its inception four years ago and served on the external subcommittee to present the program to stakeholders, including AdvaMed and the FDA.

“There has been discussion with FDA about inspecting firms less if they are MedAccred subscribers, but there have not been any assurances,” Nabar said.

He said Philips will ask its critical suppliers to become accredited. The thinking is that once the program gains a critical mass of subscribers, manufacturers will have more clout to demand accreditation of their suppliers. But that will take time.

“There are very few mandated technical standards in the medical device industry,” he said, “so this program helps at the process level to have agreement among industry stakeholders, and it provides clarity to suppliers.”

MedAccred was modeled after the Nadcap program, an aerospace industry accreditation program, which is also administered by PRI.

The Federal Aviation Administration and NASA recognize Nadcap as an acceptable means for manufacturers to manage their supply chains, and the hope is that the FDA will support the MedAccred program once it gets going, Pinto said.

In its nascent stages, the program is also comparable to Rx360, a consortium of 25 drugmakers that worked together to develop standards to ensure product quality throughout their supply chains.

Supplier Feedback

Solar Atmospheres was the first supplier to be accredited under the MedAccred program. The company is a heat treater for medical devices such as implantable joints, battery cases for pacemakers and other surgical tools.

Ed Engelhard, corporate quality manager for Solar Atmospheres, works with about seven to eight devicemakers as well as aerospace manufacturers. He said the device industry is much less transparent than the aerospace industry.

“In the aerospace industry, I know exactly whose product I am working on at all times because everybody above me in the supply chain is required to pass that information along.”

He said the MedAccred audit was a rigorous process that took a deep dive into each critical process. Auditors are subject matter experts with about 25 years of experience in the specific processes for which they are evaluating, and they may ask up to 1,000 questions, Engelhard said. He noted that ISO, or quality system audits, are more general in scope because they cover different facets of the business as it relates to processes and recordkeeping.

“The single biggest benefit to a supplier,” he said, “is that in order to answer the audit criteria, you will have to establish very detailed and well-thought out procedures so you know you will meet the requirements no matter when an auditor shows up.”

“MedAccred will be very good for the medical public in the same way that Nadcap has been good for the flying public.”

You’re probably not surprised that in 2013, violations of the purchasing controls requirement ranked among the top 10 FDA citations involving quality systems regulations. Despite many fewer FDA inspections of devicemakers over the last three years, the number of 483s issued to companies like yours rose 12%. Worried how you’re managing your suppliers? Buy FDAnews’ Device Supplier Controls: Avoiding an FDA Form 483 and eliminate the guesswork.