MEDACCRED MANAGEMENT COUNCIL

AUGUST 2014

CONFIRMED MINUTES

CONFIRMED MINUTES

AUGUST 6, 2014

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, AUGUST 6, 2014

1.0  OPENING COMMENTS

1.1  Call to Order / Quorum Check

The MedAccred Management Council (MMC) WebEx & Teleconference Meeting was called to order at 10:00 a.m., 06-Aug-2014, with the following representatives in attendance:

Subscriber Participants Present

None

Other Participants Present

NAME / COMPANY NAME
Georgetta / Carr / Medtronic, Inc.
Ed / Engelhard / Solar Atmospheres
Robert / Hayden / Industrial Metal Finishing, Inc.
Tim / McGinnis / Sanmina Medical Division
Shonte / Pettiford / Abbott
Ken / Stopar / Baxter Healthcare Corporation

PRI Staff Present

Jerry / Aston
Mark / Aubele
Marcel / Cuperman
Bill / Dumas
Rebekah / Gondek
Justin / McCabe
Kellie / O’Connor
Joe / Pinto
Christine / Sanz

1.2  Anti-trust and Code of Ethics

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

1.3  The agenda was reviewed. Minutes from the 11-Jul-2014 meeting were reviewed and approved.

2.0  Rolling Action Item List (RAIL)

The current RAIL was reviewed.

·  Item #133: The list of industry associations was sent to all MMC & Task Group representatives to identify any associations or organizations that it would be wise to approach and educate on MedAccred program. An update will be given at next meeting.

·  Item #135: An email was distributed last week to determine the need for a NonDestructive Testing (NDT) Task Group. Some feedback has been received, and an update will be given at the next MMC meeting in September. A similar request has also been sent regarding the potential for a Plastics Task Group.

3.0  MMC Sub-Team Activities: Recap and Discussion

3.1  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. In addition to this list, PRI is looking to publish articles in industry publications and staff are currently working to develop a marketing strategy. This strategy will be reviewed and discussed with the External Communications & Strategy Sub-Team to determine the best publications to publish in. If anyone has any feedback or input, please contact Bekah Gondek.

3.2  Program Documents

This sub-team is nearing completion with a final goal of publishing the program document on eAuditNet, once the website goes live. This is anticipated sometime in mid-late August. The document will be easily accessible to all participants, current and future, once published online in eAuditNet.

3.3  MMC Face-to-Face Meetings

Face-to-face meetings are a critical part of the program, as this is where the group can develop strategy and provoke participation and open discussion, working collaboratively to make continual improvements to the MedAccred Program. The next meeting is scheduled at PRI Headquarters on 1 October 2014. Participants from both the MMC as well as the Task Groups are highly encouraged to attend.

A registration has been created, so all participants (whether attending in person or via WebEx) are highly encouraged to pre-register for this meeting by using the following link: http://events.constantcontact.com/register/event?llr=t4cxmocab&oeidk=a07e9bcf3ww6ecd9e00

4.0  TASk group activities

4.1  Electronics – Cable & Harness (C&H)

The Task Group is meeting regularly and are continuing to revise the checklist, with great participation at the calls. The estimated completion date for this group is currently early November 2014.

4.2  Electronics – Printed Circuit Board Assemblies (PCBA)

The PCBA Task Group has elected Task Group leadership: Chairperson - Robyn Miller of Baxter Healthcare; Vice Chairperson - Bruce Badger of GE Healthcare. The group has completed the initial ballot of the checklist and have a number of proposed revisions, most of them editorial. The Task Group is now working to review all comments, with hope of resolutions being complete by late August, when a second ballot will be distributed. At some point, the Task Group may need to develop a printed board checklist, however that will not happen until the initial checklists are completed. Also, the two Electronics groups, C&H and PCBA, may ultimately become unified as one group as part of their long-term development.

4.3  Heat Treating (HT)

The checklist was sent to an affirmation ballot on 05-Aug-2014, and is not expected to generate any additional comments. Therefore upon completion, the checklist will be sent to the MMC for final review, approval and release. The Task Group has a meeting scheduled for 20-Aug-2014 to begin discussing requirements for auditors, as the group already has one Nadcap auditor who with Medical Device experience who is willing to participate in MedAccred. Additionally, the Task Group is going to begin working on checklists for other HT processes.

4.4  Sterilization (STN)

The STN Task Group is very focused on development of checklists, having bi-weekly meetings. They are now working on AC8113/1, Gamma & Electron Beam. The base checklist is ready to be used on test audits, however the slash sheets must be completed first. The estimated dates of completion have been pushed back slightly. Mark Aubele is also scheduled to observe a Gamma audit with Cheryl Work, Task Group Chairperson.

4.5  Welding (WLD)

The WLD Task Group has made good progress, with the base checklist and first two slash sheets (fusion weld & welder qualification) completed and ready for MMC ballot. The Task Group is now working to develop a 3rd slash sheet checklist for laser weld. Interviews for two auditor candidates have been pushed to September. Joe Pinto asked MMC members to encourage their technical experts to join the Task Groups.

5.0  OPEN DISCUSSION & Other Business

5.1  Ballots

As mentioned during the Heat Treating and Welding Task Group reports, once the checklists have been balloted to the Task Group and approved, the next step in the process for approving audit criteria is to send the checklists on an affirmation ballot to the MMC. While the task groups approve the actual content of the criteria, the Management Council receives the checklists for information on the criteria and scope. The MMC is asked to review the criteria on a broader level, with the understanding that the technical experts within the task groups have already worked on the technical content. This is also an opportunity to provide comments or ask questions if there is a gap or problem with the criteria. MMC Members are encouraged at this stage is to share this criteria within their company to discuss what work is taking place in MedAccred.

5.2  eAuditNet

PRI is currently working to develop eAuditNet for support of the MedAccred program. It is nearing completion and before long participants and companies will need to register for an online account in eAuditNet. An email will go out as soon as this functionality is available, giving details on how to register. The first section of eAuditNet to be implemented will be the electronic balloting process. Since eAuditNet is new to MedAccred participants, PRI will conduct a training on usage and available functionality. More information will be forthcoming.

5.3  Subscriber Participation

Since the last meeting, Stryker has joined MedAccred as a Subscribing OEM, which brings us to three Subscribers. Mandating is a new process for the medical device industry. As a result, there is a meeting scheduled next week with Subscribing OEMs on how to identify which suppliers should be accredited and how to go through the mandating process. With the Task Groups nearing audit readiness, this meeting will help develop a plan and process to begin auditing suppliers.

5.4  Other Business

As a reminder, MMC and Task Group members are encouraged to attend the face-to-face meeting on 01-Oct-2014. Additionally, there is a MedAccred Introduction Training session scheduled for 13-Aug-2014, which is a good way to get more details, ask questions, and learn how the program will work. If there are members within your company you wish to attend, please let us know and we will forward the invitation. This is a great opportunity for new participants and companies to learn more about MedAccred and where the program is headed.

6.0  rolling action item list (RAIL) review

No new action items were identified during this meeting.

ADJOURNMENT – 11-Jul-2014 – Meeting was adjourned at 11:00 a.m. The next teleconference call is scheduled for 10-Sep-2014.

Minutes Prepared by: Kellie O’Connor,