MEDACCRED MANAGEMENT COUNCIL

JANUARY 2016

CONFIRMED

CONFIRMED MINUTES

JANUARY13,2016

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, JANUARY 13, 2016

1.0OPENING COMMENTS

1.1Call to Order / Quorum Check / Introductions

The MedAccred Management Council (MMC)WebEx & Teleconference Meeting was called to order at 11:00 a.m.EST, 13-Jan-2016, with the following representativesin attendance:

MMC Members Present

NAME / TITLE / COMPANY NAME
Andrew / Bauermeister / Sr. Sourcing Engineer / Medtronic
John / Bryson / Regional Technical Manager / Bodycote
Ed / Engelhard / Vice President of Corporate Quality / Solar Atmospheres
Scott / Goolsbey / Supplier Controls Manager - Stryker Endoscopy / Stryker
Acelio / Hernandez / Global Director of Quality and Regulatory Affairs / Nypro Healthcare
Vance / Kyle / Joint Recon Supplier Quality Manager / DePuySynthes
David / Mailes / Director of Quality / Paulo
Steve / Niedelman / Consultant / King & Spalding Law
Jeff / Olds / CEO / Global Technologies
Christina / Rubio-Sprague / Vice President Supply Chain / Vention Medical

PRI Staff Present

Mark / Aubele / Senior Program Manager, Staff Engineer, Sterilization / PRI
Connie / Conboy / Director, Strategy and Business Development / PRI
Marcel / Cuperman / Senior Staff Engineer – Heat Treating / PRI
Susan / Frailey / Lead Staff Engineer – MQS / PRI
Hannah / Godfrey / Senior Specialist, Business Development Europe, MedAccred Co-Lead / PRI
Joanna / Kennedy / Manager, Communications and European Customer Relations / PRI
Julia / Markardt / Staff Engineer, PCBA and C&WH / PRI
Justin / McCabe / Senior Specialist, Business Development, MedAccred Co-Lead / PRI
Kellie / O’Connor / Program Coordinator, Nadcap & MedAccred / PRI
Joseph / Pinto / Vice President & Chief Operating Officer / PRI

1.2Code of Ethics, Anti-trust and Conflict of Interest

Justin McCabe showed the PRICode of Ethics, Anti-trust and Conflict of Interest policy. To view the video, please use the following link:

1.3Connie Conboy reviewed the agenda.

1.4Approval of MMC Minutes

1.4.1Motion made by David Mailesand seconded bySteve Niedelman to approve 11-Nov-2015teleconference minutesas written. All in favor and minutes were approved.

2.0REVIEw of 2016 goals

Connie Conboy reviewed the MedAccred goals for 2016. For more details on the 2016 goals, the current status, as well as the intended approach to achieve them, please see the list below.

FDA engagement:Steve Niedelman also reported that the FDA would like MedAccred to present at an upcoming Critical to Quality sub-group meeting.

3.0upcoming audits

There are currently 9 audits scheduled or completed for 2016, including two which are reaccreditation audits.

There is a back-to-back Heat Treating MedAccred audit and Nadcap audit taking place this week for the first time.

The first Cable Wire Harness audit will take place in January. Additionally, a pilot Plastics audit took place last week and went very well.

4.0Task Group HIGHLIGHTS

PRI Staff Engineers provided a brief update on the status for their respective Task Group activities. For more details, please see the chart below.

5.0process validation sub-team update

Justin McCabe gavea status update on the Process Validation Sub-Team’s activities.

Current Status:

  • General Process Validation questions completed (December 2015)
  • GAP Matrix document in development – expected to be approved 18-Jan-2016
  • Training materials in development

Next Steps:

  • Roll-out General Process Validation questions to all MedAccred Task Groups
  • Begin developing process-specific Process Validation questions

Sterilization, Plastics, PCBAs and Cable and Wire Harnesses already have process validation well covered in their audit criteria and will not require significant additional work. Heat Treating and Welding will require the most additional input in this area.

6.0upcoming events & opportunities

Hannah Godfrey reviewed the upcoming MedAccred Events:

Industry Events:

MD&M West – FEBRUARY 2016 (see details in chart below)

Anaheim, California, USA

  • Lunch & Learn
  • Paper
  • MMC Meeting

Medical Device Quality Congress – MARCH 2016

Rockville, Maryland, USA

  • Paper to be presented by Joe Pinto

Medical Device Supplier Quality: Efficiency & Collaboration Conference – APRIL 2016

Arlington, Virginia, USA

  • Joe Pinto to participate in panel discussion

Implants 2016 – JUNE 2016

Paris, France

  • Keynote
  • Booth

AdvaMed 2016 – OCTOBER 2016

Minneapolis, Minnesota

  • Booth

At MD&M West in mid-February, the MedAccred Management Council will be meeting face-to-face, along with some additional activities. For details, please see below.

Event / Date / Time / Registration / Location / Title / Presenters/ Attendees
MMC Meeting (Roundtable) / Wednesday, 10Feb16 / 8:00am – 11:30am
1:30pm – 5:00pm / Constant Contact - to be sent by PRI / Anaheim Convention Center - Room 209AB / Agenda to follow / MMC Members
MD&M Lunch & Learn (Panel Discussion) / Wednesday, 10Feb16 / 11:45am – 1:00pm / Please provide names of any company representatives you would like to invite / Anaheim Convention Center - Room 209AB / Perspectives on MedAccred: An industry-managed solution to critical process oversight / Invitation Only
MD&M Conference (Presentation) / Thursday, 11Feb16 / 10:30am – 11:00am / MD&M Conference Registration / Conference Hall – Room TBD / MedAccred: Innovating critical process manufacturing oversight / Ravi Nabar
Robert Berger
Gary Switzer (Sanmina)

Other 2016 Events:

Global Johnson & Johnson Supplier Webconference (February 2016)

  • Approximately 50 of their key suppliers invited (HT, WLD, PLA, PCBA, C&WH & STN)
  • Support from Global VP of Supplier Quality / Global Head of Procurement
  • Objective: to introduce MedAccred and recommend accreditation

Medmarc

  • Plans to announce reduction in liability insurance for accredited suppliers
  • Informational webinar scheduled for 17-Feb-2016
  • Series of 6 webinars focused on each critical process will begin June 2016

7.0OTHER business

7.1Batteries Sub-Team

We are currently looking for volunteers to identify critical process areas for battery manufacturing and support the future direction for a task group. Justin McCabe sent an email request for SME participation on this team last week, so if anyone has a participant in mind, please forward those names to PRI Staff.

7.2Auditors

If you have individuals that you know of who has expertise in any of our current critical process areas who may be interested in becoming an auditor, please direct them to PRI.

7.3Proposed MMC Meeting Schedule

The following dates are proposed for the 2016 MMC Meetings:

  • February 10 (Face-to-face, Anaheim Convention Center)
  • March 9 (WebEx / Teleconference)
  • April 6 (WebEx / Teleconference)
  • May 4 (WebEx / Teleconference)
  • June 8 (Face-to-face, Location TBD)
  • July 6 (WebEx / Teleconference)
  • August 10 (WebEx / Teleconference)
  • September 7 (WebEx / Teleconference)
  • October 12 (WebEx / Teleconference)
  • November 9 (Face-to-face, Location TBD)
  • December 7 (WebEx / Teleconference)

If any companies are interested in hosting a meeting, please let PRI know.

8.0RAIL REVIEW

Connie Conboy provided an update on our Rolling Action Item List (RAIL). Please see the table below for details.

STATUS / SUMMARY
CLOSED / Subscribers to identify one supplier facility for a Cable & Wire Harness audit.
CLOSED / Subscribers to identify one supplier facility for a Sterilization audit.
OPEN / Ravi Nabar and Robert Berger to determine if there is someone who can support the MQS Task Group as a Chair or Secretary
IN PROCESS / OEMs/CMs to provide names of Batteries SMEs to form an MMC sub-team that will explore viability of establishing a Batteries Task Group
IN PROCESS / Process Validation sub-team to develop and provide Process Validation training for MedAccred program stakeholders (Auditors, Suppliers, Staff Engineers, others)
OPEN / External Communications and Strategy sub-team to give further consideration to an FDA observation of a MedAccred audit
IN PROCESS / Steve Niedelman and Ravi Nabar to look into intersect between MedAccred and the PMA process and report to MMC

ADJOURNMENT –13-Jan-2016 – Meeting was adjourned at 12:00p.m.

Minutes Prepared by:Kellie O’Connor,