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Industry-Managed Critical Manufacturing Process Supply Chain Quality Oversight Program for the Medical Device Industry

MedAccred Management Council and Task Group Teleconference

MinutesApril 09, 2014

Participants AffiliationJim Ahle Stryker CorporationAlan Barnhart Stryker CorporationMike Brown Stryker CorporationBruce Dall Stryker CorporationJennifer Doubet Boston Scientific CorporationEd Engelhard Solar AtmospheresNeil Hirschey Professional PlatingDavid L. Jones Stryker CorporationVance Kyle DePuyMichael Lau Stryker CorporationPaul Mehta Philips HealthcareRobyn Miller Baxter Healthcare CorporationLoretta Mooney Philips HealthcareKen Stopar Baxter Healthcare CorporationJeff Runyon American Medical TestingDaniel Whalen Baxter Healthcare CorporationCheryl Work Becton, Dickinson & Co.

Jerry Aston PRIMark Aubele PRIHannah Godfrey PRIRebekah Gondek PRIJustin McCabe PRIKellie O'Connor PRIChristine Sanz PRI

Time Item

10.30 Opening Remarks and Welcome Anti-Trust/Code of Ethics

Participants of the MedAccred Management Council (MMC) and Task Groups were welcomed and the Anti-Trust and Code of Ethics slides were reviewed.

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Bekah Gondek, MedAccred Co-Lead, Manager Nadcap Program Quality and NUCAP, Performance Review Institute

10.35

Task Groups Report Out

Embedded slides were reviewed. Printed Circuit Board Assemblies have completed the first pass of the checklist. One

notable concern is the use of the word “compliance” in the checklist when referring to job audits. The term “compliance’ in the medical device industry means compliance to FDA requirements. The Task Group suggests using the term “conformance” in lieu of “compliance”. After some discussion, it was determined that this might not apply to all Task Groups.

ACTION ITEM – PRI Staff to bring this topic to Task Groups for discussion on what terminology to use so it can be consistent across the program.

Once terminology has been settled upon by the Task Groups, it will be defined in the program documents.

Cable & Harness conducted a proof of concept audit at Global Technologies in mid-March. Post-audit recap discussion was very positive, with participants expressing that a good portion of the Nadcap requirements could apply to MedAccred as well. Additionally, the group will need to add new requirements for some areas that are not currently covered.

Heat Treating has finalized the first draft of the baseline checklist and are ready to ballot imminently. The group has decided to adopt AMS2750 as their Pyrometry specification. One concern of the group is flowdown to suppliers of the Heat Treating mandates.

Sterilization has completed an initial draft of the baseline checklist, AC8113. Once an additional checklist has been completed, it will be ready for a Proof of Concept (POC) audit. Mark explained that a baseline checklist is a set of very basic requirements that would be audited during all MedAccred Sterilization audits, along with the specific method checklist (or slash sheet) that the supplier is seeking accreditation for. The Sterilization Task Group is also planning to hold a face-to-face meeting in mid-May, and Mark asked for MMC support to allow participants to attend, in hopes that he can have quorum attendance at the meeting.

Bekah noted that quorum is an important concept used by Nadcap to make Task Group activity official so that decisions can be made. Once the MedAccred program has 3 Subscribers, this concept will be applied there as well.

Welding is working to finalize checklists and is planning to develop handbooks in correlation with the checklists. The Task Group repeated their request for consideration of a NonDestructive Testing Task Group.

Electronic Circuits (PCBA) – Bill Dumas, Senior Staff Engineer, Performance Review InstituteCable & Harness (C&H) – Bill Dumas, Senior Staff Engineer, Performance Review InstituteSterilization (STN) – Mark Aubele, Senior Program Manager, Performance Review InstituteHeat Treatment (HT) – Marcel Cuperman, Senior Staff Engineer, Performance Review InstituteWelding (WLD) – Ian Simpson, Associate Program Manager, Performance Review Institute

10.55 PMC Sub-Team Updates Proof of Concept Audits Program Documents External Communications and Strategy


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Embedded slides were reviewed. Proof of Concept Audits: There have now been four proof of concept audits conducted

in the various Task Groups of the MedAccred Program, which meets the sub-team’s original goal. Bekah proposed that at this time we sunset (retire) this sub-team. Jim Ahle (Stryker), Ken Stopar (Baxter) and Vance Kyle (DePuy) agreed to dissolve the team.

Program Documents: PD1300 will be sent to participants for a 21-day review period today, April 9, 2014. Following this review period, approval of PD1300 will be documented at the May 6th face-to-face meeting at Xavier University in Cincinnati, Ohio (in conjunction with MedCon).

External Communications & Strategy: This is currently the most active sub-team, with several upcoming activities highlighted. In early April, Ken Stopar (Baxter) presented at the Medical Device Supplier Quality Assurance Conference and he noted that after the presentation, a number of people approached him about getting more information and showed great interest. He obtained business cards from all interested parties, and will work with Bekah to reach out to them, as some of the people are from companies that are not yet involved in the MedAccred program.


11.05

Required Quality System for MedAccred – Approve Final Requirements

Following discussion from the December 2013 meeting, Bekah reviewed options with regard to defining what Quality Management System (QMS) certificates will meet the needs of MedAccred. There was discussion about the number of acceptable QMS certificates, and how individual Task Groups may create more stringent requirements if necessary. Additionally, MedAccred can create a Quality Systems Task Group, which would develop a 1-day quality audit, which would be performed in conjunction with a Task Group audit, similar to the Aerospace Quality Systems Task Group in Nadcap.

ACTION ITEM – Individual Task Groups to discuss and evaluate what Quality Systems are acceptable for their commodity, and a matrix will be formed once information is received from all Task Groups. Results to be presented during the 6 May face-to-face MMC meeting.


11.25

Mandating MedAccred to Supply Chain

One of the main successes of the Nadcap program is the commitment from Nadcap Subscribers to mandate accreditation to their supply chain. Bekah noted that PRI will need to be notified of all planned mandates, as PRI will maintain a matrix (see Nadcap Prime Matrix in embedded presentation as example). It was noted that this is an important consideration for potential MedAccred Subscribers, and there should be a roll-out plan for implementation. Audit preparation is vital, and suppliers will need time to properly prepare (note a minimum of 6 months is advised in Nadcap, an established program).

Bekah Gondek, Manager Nadcap Program Quality and NUCAP, Performance Review Institute

11.45 MedAccred Status Review and On-going Action Items Independent Contractors


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Software Validation

Following a review of the development plan, there was discussion about the plan for recruitment of auditors and the development of PRI’s eAuditNet software, which will be used for review and record retention of the audits.

RAIL was not reviewed during the meeting but has been updated as follows:


11.55

Open DiscussionOpportunity for all participants to share thoughts on any aspect of MedAccred program.

Ed Engelhard noted that OEMs will likely need to be as encouraging to the supply chain as possible because this whole program may be a very foreign idea to them. It is also important to recognize the time and cost involved for a supplier, and OEMs may want to consider fewer on-site visits to the suppliers, in recognition or validation of a supplier’s MedAccred accreditation.

Reminder: There is a face-to-face MMC meeting scheduled for May 6, 2014 at Xavier University in conjunction with MedCon. If anyone wishes to participate, please contact Rebekah Gondek for further information at [email protected].


12.00 Adjourn


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