MEDACCRED MANAGEMENT COUNCILOCTOBER 2014

CONFIRMED MINUTES

CONFIRMED MINUTESOCTOBER 1, 2014

FACE-TO-FACE / WEBEX / TELECONFERENCE CALL

These minutes are not final until confirmed by the MedAccred Management Council in writing or by vote at a subsequent meeting. Information herein does not constitute a communication or recommendation from the MedAccred Management Council and shall not be considered as such by any agency.

WEDNESDAY, OCTOBER 1, 2014

1.0 OPENING COMMENTS

1.1 Call to Order / Quorum Check

The MedAccred Management Council (MMC) and Task Groups Face-to-Face, WebEx & Teleconference Meeting was called to order at 8:30 a.m., 01-Oct-2014, with the following representatives in attendance:

Subscriber Participants Present

Jim Ahle Stryker CorporationBruce Dall Stryker Corporation Via Teleconference David Jones Stryker Corporation Via TeleconferenceVance Kyle DePuy SynthesRavi Nabar Philips HealthcareJudy Nathan DePuy Synthes Via TeleconferenceAmy Sousa Johnson & Johnson

Other Participants Present

NAME COMPANY NAME

Bruce Badger GE Healthcare Via TeleconferenceMicky Bradican Applied Thermal Technologies Inc.Georgetta Carr MedtronicJeff Crist Cadence, Inc.Ed Engelhard Solar Atmospheres Inc.Wendy Gould Synergy HealthRobyn Miller BaxterSteve Niedelman King & SpaldingDan Solowy Global Technologies Via TeleconferenceKen Stopar Baxter Via TeleconferenceCheryl Work Becton Dickinson

PRI Staff Present

Jerry AstonMark AubeleJoyce BenkartBill DumasRebekah GondekBob LizewskiJulia MarkardtJustin McCabeStacey McKinleyBrittany McSorleyKellie O’ConnorJoe Pinto

MEDACCRED MANAGEMENT COUNCILOCTOBER 2014

CONFIRMED MINUTES

Kellie RoachIan Simpson

1.2 Anti-trust and Code of Ethics

Rebekah Gondek reviewed the Anti-trust and Code of Ethics policy. For more information, please see the attached presentation.

1.3 The agenda was reviewed.

1.4 Motion made and seconded to approve the September MMC Minutes. Motion passed and the minutes from the 10-Sep-2014 meeting were approved.

1.5 Joe Pinto noted that Bekah Gondek is leaving PRI as of 03-Oct-2014 and thanked her for all of her hard work and involvement with the MedAccred team. Bob Lizewski, Nadcap Coatings Staff Engineer and Staff Engineer SWAT Team Lead, was introduced to the group and will be transitioning into her role in both Nadcap and MedAccred.

2.0 MMC SUB-TEAM ACTIVITIES: RECAP AND DISCUSSION

2.1 External Communications and Strategy

An update of this team’s recent and upcoming activities was reported. For more details, please see the attached presentation above. Additionally, it was noted that an editorial article written by Ravi Nabar has now been published. It is available on the PRI Website (www.p-r-i.org) under “Latest News”.

2.2 Program Documents

The program document PD1300 was released on 29-Sep-2014. This is the governing document of the MedAccred program. It is published in eAuditNet under the Resources menu – Documents – Public Documents – MedAccred Program Document. This document will be owned by the Management Council, who will be able to review and make revisions via the balloting process. For this reason, it is imperative that all members register in eAuditNet. All balloting is conducted electronically in eAuditNet, and all of our program documents and Task Group checklists will be published there. This is also where all of the audit data will be housed.

It was noted that there is a higher level document to PD1300. PD1000 outlines what an Industry Managed Program is. This document is also published in eAuditNet. Justin McCabe noted that PRI will be conducting some training sessions on the document structure in the near future.

Bekah conducted a brief overview of eAuditNet and where the different documents are located. It was explained that each Subscriber or Supplier company will select an eAuditNet Administrator from their company. This person will be responsible for granting access to any additional company participants. Bekah noted that there will be a training session on the functionality of eAuditNet in addition to the document structure training. MedAccred members are highly encouraged to participate in these training sessions.

MEDACCRED MANAGEMENT COUNCILOCTOBER 2014

CONFIRMED MINUTES

3.0 MEDACCRED QUALITY SYSTEMS

Justin provided an update on this sub-team. Progress has been slow, however the team is hoping to move on this action following this face-to-face meeting. For more details and background on this sub-team, please see the attached presentation:

Ed Engelhard noted that the AC7004, PRI’s Aerospace Quality System audit checklist, is a robust document and encouraged participants to review it as a potential reasonably priced alternative to ISO 9001 or 13485.

There was some discussion about whether it was acceptable to offer an AC7004 alternative for the MedAccred program, as it may be difficult to defend to the FDA since it hasn’t been vetted through them. It was noted that the FDA does not specifically require suppliers to have a quality system, and the responsibility lies with the manufacturers to ensure their supply base have a quality management system. Additionally, each Task Group is able to choose what quality systems are acceptable for their critical manufacturing process.

ACTION ITEM: PRI Staff to add Wendy Gould, Georgetta Carr, Vance Kyle and Jim Ahle (if participants are necessary) to this sub-team as it moves forward.

4.0 PROCESS VALIDATION

There was some discussion on standardizing process validation requirements for the MedAccred program. For more details, please see the attached presentation:

Following some discussion, it was determined that MedAccred needs to be able to provide evidence that the AMS specifications and other relevant standards will be equivalent, or even more robust, than the current FDA validation requirements. The group agreed that Heat Treating (HT) is the best place to start. Once this has been successful in HT Task Group, we can look at the other processes.

There is an existing action item which was put on hold following the last face-to-face meeting in May 2014 to take 2750 to the FDA for incorporation into the approved industry standards. The group agreed to reinstate this action and pass ownership to the HT Task Group, who will also pull together a package of information to present to the FDA.

ACTION ITEM: HT Task Group to put together a package that shows what MedAccred is doing satisfies the FDA process validation by OEM requirements. Once the package is created and vetted by the MMC, then it will be taken to the FDA Office of Compliance (Bill McFarland).

5.0 TASK GROUP ACTIVITIES

MEDACCRED MANAGEMENT COUNCILOCTOBER 2014

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5.1 Electronics - Cable & Harness (C&H)

Task Group has regularly scheduled meeting, and will conduct a meeting concurrently during the face-to-face meeting today. The group continues to work on the checklist revisions. The expected date of completion for the checklists is early December. They expect to contract their first auditor early next year, and Julia Markardt, who will be taking over as the Staff Engineer for both Electronics groups, will likely become one of the first approved auditors. They expect that the first audits may take place early next year, based on the finalization date of the checklists. The audit duration is expected to be four days.

It was noted that there are some general quality system checklist requirements that are verified at that critical process level. This is consistent with Nadcap where the process audit verifies the effectiveness of the quality system and not only its existence.

To ensure that the content of the checklists contain the requirements that each OEM needs in order to accept a MedAccred audit, it is vital to have industry participation in each of the Task Groups, even prior to officially subscribing to the program.

5.2 Electronics - Printed Circuit Board Assemblies (PCBA)

There is good participation and the group is progressing well. They are currently working to resolve comments from the recent ballot. The checklist will likely be completed in early November, and first audits will likely be able to be conducted early next year. Supplier participation is fairly low, and the Task Group would like to see additional supplier support.

5.3 Heat Treating (HT)

There is a great level of support and participation in this group, with regular monthly meetings. The core checklist is currently released and ready for use. The slash sheets are currently in development and nearing completion. Once completed, they will be used in conjunction with the core checklist.

As the core checklist is complete, the Task Group is ready to conduct audits at this time.. The Task Group has contracted its first auditor and has a Supplier who has volunteered to conduct the first audit.

There was some discussion about conducting a joint Nadcap and MedAccred audit for those medical device suppliers who are also Nadcap accredited. Joe Pinto noted that the ultimate goal is for a joint audit to be available, however this is likely a few years away.

5.4 Sterilization (STN)

The Task Group has good participation.The base core checklist AC8113 has been completed as well as the first draft of the Gamma slash sheet AC8113/1. A second slash sheet, AC8113/2 for Ethyleneoxide, is now in development and expected to be completed in October. Compared with other Task Groups, it is difficult to witness the critical process as a job audit due to the quick turnaround time, so the Task Group may need to consider documentation review as an alternative to the normal job audit.

One concern of the group is participation between meetings. Meeting participation is good in general, however participants have little time in between the meetings to review and edit the checklists. This has slowed the progress slightly, however the group is still moving along.

5.5 Welding (WLD)

The level of support in this Task Group is fairly consistent. The three checklists, including a core checklist and two slash sheets, are now complete and ready for auditing. Two auditors have been approved and contracted. The Task Group is now working to develop checklist handbooks and an additional slash sheet for laser weld.

MEDACCRED MANAGEMENT COUNCILOCTOBER 2014

CONFIRMED MINUTES

The Welding Task Group again suggested that we look at developing a Nondestructive Testing (NDT) Task Group. Justin McCabe solicited feedback from the MedAccred participants and there was limited interest at this time. As a result, NDT will not go forward at this time.

6.0 FDA NEXT STEPS

It’s been nearly a year since MedAccred last presented to the FDA. It is important to keep them engaged and informed, however, until at least 10-15 audits have been conducted, there is not a lot of value in having a face-to-face with the FDA. Alternatively, a good next step may be to send them the MedAccred checklists to show the work that’s been done.

The first audits will be critical as evidence that this is a robust process. We need to start thinking strategically about what we want from the FDA, what their role is and how they can support us by encouraging companies to use MedAccred. There was a suggestion that potential suppliers conduct a self-assessment to the checklists prior to their MedAccred audit, and compare those to the actual results of the audit. If there is a dramatic difference between how suppliers view their system and the actual state of their system, this may demonstrate value to the FDA.

At this time, there will be no action in regards to the FDA. This topic will be discussed again at the December face-to-face MMC meeting to decide whether to send checklists and/or additional information to the FDA.

PRI to stay abreast of FDA activities through organizations such as MDMA, MDIC, MedCon and Case for Quality.

ACTION: PRI to get in touch with Marla Philips (MedCon) to participate in Case for Quality initiative.

ACTION: Steve Niedelman to connect PRI to MDMA’s Executive Vice President.

7.0 EAUDITNET UPDATE

Jon Steffey gave an update of the eAuditNet (audit management software) development for MedAccred and how the timeline is progressing with the software validation requirements. For more details, please see the attached presentation.

There was some discussion about auditor qualifications and where they are housed. For the Nadcap program, this information is not housed within eAuditNet, however it is documented and records retained. For the MedAccred program, the qualifications, resumes, interview results and training records may need to be more readily available to the Subscribers per FDA requirements. This topic may need to be added to PD1300 to outline what specific information is necessary and where it will be housed.

8.0 2015 GOAL PLANNING

8.1 Additional Task Groups

There was discussion about possibly creating a Task Group for Batteries. However, there seems to be limited interest. If there is adequate support and industry willingness to participate, a new Task Group can be developed. There was agreement that we need to ensure the current Task Groups are successfully launched and conducting audits before launching any additional process groups. However there is a possibility that additional participants may become engaged in the program if we start a Plastics Task Group.

MEDACCRED MANAGEMENT COUNCILOCTOBER 2014

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ACTION ITEM: Justin McCabe to schedule a meeting to further discuss the possibility of creating a Plastics Task Group. Baxter, BD, Stryker, Philips, Boston Scientific, DePuy and Medtronic to be invited.

8.2 Plan for 2015

There was some discussion about strategic goals for the MedAccred program in 2015, including industry conferences and opportunities to present, as well as training opportunities for MedAccred participants.

The topic of mandates and incentivizing suppliers to become accredited was brought up. Strategically, a good way for an OEM to roll this out to their supply base would be to start by contacting a select list of suppliers who they believe would benefit from becoming MedAccred accredited. Mandates will likely follow a couple of years later, once there are suppliers who are accredited. In the meantime, perhaps the supply base could be encouraged to conduct a gap analysis against the MedAccred checklists with the knowledge that in a couple of years, this is going to become required.

ACTION ITEM: Each OEM who provided a supplier list to PRI is to review and begin targeting those suppliers for early MedAccred audits.PRI will be available for any necessary support, such as at supplier symposiums.

8.3 MMC Face-to-Face Meetings

There are four face-to-face meetings proposed for 2015, including two meetings at PRI Headquarters in Warrendale, PA. Please see the updated list below:

February 18: Memphis, Tennessee

May 20: Pittsburgh, Pennsylvania

September 23: Boston, Massachusetts

December 2: Pittsburgh, Pennsylvania

The Task Groups will be invited to participate during the May 2015 meeting in Pittsburgh. Additionally, PRI has a professional development program which conducts courses globally on topics such as Internal Auditing, RCCA, Audit Preparation and Problem Solving Tools for a nominal fee. A workshop will be held at the February 2015 meeting to introduce the MedAccred program to Suppliers and the opportunities for additional training through the PRI professional development program.

8.4 Targets

The current scope of the MedAccred program is approximately 350 suppliers based on input from the Subscribers as well as a few other participating OEMs.

The group agreed on the following targets for 2015:

Subscribers: 10-15

Supplier Audits: 50-100

New Technologies: 2-3

MEDACCRED MANAGEMENT COUNCILOCTOBER 2014

CONFIRMED MINUTES

9.0 OTHER BUSINESS AND OPEN DISCUSSION

9.1 Ed Engelhard cautioned the group that the MedAccred Task Groups should not be removing the Export Control notations from the checklists, because there are products in the medical device industry which are export controlled. Joe Pinto noted that MedAccred should also consider adding EAR information into the program document PD1300. Every Task Group should be evaluating their audit criteria to identify anything that is export control restricted information.

ACTION ITEM: Justin & Bob to ask MedAccred Staff Engineers to begin export control discussions with their respective Task Groups during the next MedAccred Staff meeting.

10.0 ROLLING ACTION ITEM LIST (RAIL) REVIEW

The actions identified during this meeting were reviewed.

ADJOURNMENT – 01-Oct-2014 – Meeting was adjourned at 4:30 p.m.

Minutes Prepared by: Kellie O’Connor, koconnor@p-r-i.org