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MEDACCRED MANAGEMENT COUNCILMAY 2015
CONFIRMED
CONFIRMED MINUTESMAY 13, 2015
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, MAY 13, 2015
1.0 OPENING COMMENTS
1.1 Call to Order / Quorum Check
The MedAccred Management Council (MMC) Face-to-Face, WebEx & Teleconference Meeting was called to order at 8:15 a.m. EST, 13-May-2015, with the following representatives in attendance:
Subscriber Participants Present
NAME TITLE COMPANY NAME
Vance Kyle Joint Recon Supplier Quality Manager DePuy Synthes
Chris Cook Staff Quality Engineer DePuy Synthes Joint Reconstruction
Ravi Nabar Head of Supplier Quality Assurance Philips HealthTech
Paul Mehta Sr. SQ Audit Manager Philips HealthTech
Scott Goolsbey Supplier Controls Manager Stryker
Other Participants Present
NAME TITLE COMPANY NAME
Jeff Olds CEO Global Technologies
Dan Solowy VP of Operations Global Technologies
Steve Niedelman Lead Quality System and Compliance Consultant King & Spalding LLP
Jim DuBois Director, Quality Assurance & Regulatory Affairs Sanmina Corporation Via Teleconference
Ed Engelhard Corporate Quality Manager Solar Atmospheres Inc.
Phillip Brockman President Techmetals, Incorporated
PRI Staff Present
Connie Conboy Director, Strategy and Business Development PRI
Susan Frailey Staff Engineer – MQS PRI Via Teleconference
Hannah Godfrey Senior Specialist, Professional PRI Via Teleconference
MEDACCRED MANAGEMENT COUNCILMAY 2015
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Development Program Europe
Bob Lizewski Quality Manager PRI
Justin McCabe Research & Development Specialist PRI
Kellie O’Connor Program Coordinator, Nadcap & MedAccred PRI
James Phillis Controller PRI
Joe Pinto Vice President & Chief Operating Officer PRI
Jon Steffey Program Manager – Informatics Solutions PRI
1.2 Anti-trust and Code of Ethics
A video regarding the Anti-trust and Code of Ethics policy was viewed. For more information, please use the following link: https://www.youtube.com/watch?v=skr4dB9YE8c&feature=youtu.be
1.3 A review of the safety and fire exits was given.
1.4 Approval of Minutes
1.4.1 Motion made by Ed Engelhard second Ravi Nabar to approve March and April minutes
1.5 Notes:
Write a case study and tie it to IQ/OQ/PQ.
There is a definite process for supplier selection at which point suppliers are introduced to the supply chain. Proposal to encourage the procurement chain to select suppliers that are already Nadcap accredited to go through the qualification process for the medical device industry via MedAccred.
ACTION ITEM: Jeff Olds to present data comparison of class 2 & class 3 lines to the MMC.
ACTION ITEM: PRI to mine the FDA’s database for recall data in critical processes
ACTION ITEM: PRI to send MedAccred background information to Steve Niedelman for FDA news article.
Need at least three audits from each of the critical task groups (PCBA, C&WH, HT, STN) before approaching the FDA again. Need evidence that the Program functions as intended.
2.0 TASK GROUP ACTIVITIES
2.1 Electronics - Printed Circuit Board Assemblies (PCBA)
PCBA is meeting on a bi-weekly basis and are working on their auditor training course. They are approving the auditors through the Nadcap approval process, but then supplementing that with a 2-hour medical device-specific training course. The Task Group is also working to develop an
MEDACCRED MANAGEMENT COUNCILMAY 2015
CONFIRMED
audit handbook as guidance for the audit criteria. Two suppliers will be scheduling audits later this summer.
Potential suppliers for audits: Jabil, Sanmina, Flextronics, Kimball, Celestica
2.2 Electronics - Cable & Wire Harness (C&WH)
This group is working on parallel activities to the PCBA group. Their checklist has been published and they are ready to schedule audits.
ACTION ITEM: OEM Subscribers to identify one supplier facility each for PRI to target for a Cable & Wire Harness audit. (Due Date: 12-Jun-2015)
ACTION ITEM: PRI Staff to review the list of suppliers that we have to find the commonalities for targeting audits. (Due Date: 12-Jun-2015)
2.3 Heat Treating (HT)
This group has conducted one audit and is ready to conduct additional. They have finalized three slash sheets and are currently balloting two additional slash sheets.
Potential suppliers for audits: Harterei Gerster, Bodycote
ACTION ITEM: PRI Staff to develop a plan for contacting the targeted suppliers discussed during today’s meeting for purposes of scheduling audits in various Task Groups.
2.4 Plastics
The Task Group is in the early stages of development and have held three meetings to date. They are working to develop injection molding audit criteria. MMC support required to increase participation.
2.5 Sterilization (STN)
All checklists are in finished draft form, and are ready for a test audit, which will be conducted at a supplier facility in August.
Potential suppliers for audits: Steris, Sterigenics, DSM Biotech and Flextronics
2.6 Welding (WLD)
This Task Group has finalized their audit criteria as well as several slash sheets. They are ready to conduct audits at this time, and are waiting for suppliers to schedule.
Potential suppliers for audits: Microtech in Fort Wayne / Symmetry
ACTION: Vance Kyle from DePuy to contact Microtech. Perhaps Bruce or Dave from Stryker to assist.
2.7 MedAccred Quality Systems (MQS)
Susan Frailey reported that this recently formed Task Group has held one meeting to date. They are going to look for a chairperson soon. Looking to ballot the 8004 audit criteria in late Q2 or early Q3. This will be a one-day add-on to the MedAccred audit, and the Task Group has agreed to accept Nadcap approved Aerospace Quality Systems (AQS) auditors for MQS.
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3.0 SUB-TEAM ACTIVITIES
3.1 Program Documents
Bob Lizewski presented an update on the PRI and MedAccred program documentation. For more details on the structure, please see the attached presentation.
Currently, the only existing document is the PD 1300, the MedAccred Program Document. There are no existing operating procedures (OP) at this time, and the sub-team is working to develop them. These procedures will be numbered as OP 1301 – OP 13XX (depending on the number of documents to be developed).
There will be a revision of PD 1300 balloted to the MMC in early June, which will align 1300 with the Nadcap Program Document, PD 1100. The MMC Members will receive an email notification when it is ready for review, along with a tutorial on using eAuditNet for balloting.
It is recommended that the MMC considering establishing officers and voting memberships, along with formalizing meetings, including formal votes, quorum and Open/Closed sessions.
The MMC asked that the sub-team slow down their activity at this time, in order to prioritize scheduling audits in 2015.
3.2 External Communications & Strategy
3.2.1 Contract Manufacturers as Subscribers
The revised proposal regarding levels of membership and subscriptions was presented to the MMC. The changes are particularly related to the access levels of Contract Manufacturers. Contract Manufacturers can join the Program as a Subscriber, and as such will have access to all supplier data.
Motion made to approve revised definitions to Subscriber and Supplier as described in the presentation below. Motion passed unanimously.
ACTION ITEM: PRI Staff to review the MedAccred subscription agreement language to ensure no changes are needed.
ACTION ITEM: Approach Contract Manufacturers to become subscribers
Potential CMs as Subscribers: Jabil/Nypro, Celestica, Benchmark
3.2.2 What do we need to do to get momentum?
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Can we learn from Nadcap’s evolution? Nadcap evolved from the excessive costs of having each of the OEM customers coming into supplier facilities and auditing the same processes.
MMC participants to approach OEMs to participate and subscribe to the Program: GE Healthcare (approach Tim Graft), Agillant, Zimmer (timing not good - approach during summer 2015), Globus, Intuitive (Steve Niedelman and Scott Goolsbey have contacts), Wright (timing not good), Bayer (PRI has contacts), Dentsply
3.3 Process Validation
Justin McCabe gave a status update on the Process Validation Sub-Team. This sub-team last met in early April and were approaching it by gathering validation questions, collating and agreeing on which questions to include in the audit criteria, and then determining how each question relates to each technology and whether any of the questions are already covered.
Suggestion to write a case study and tie it to IQ/OQ/PQ.
ACTION ITEM: Process Validation sub-team to develop a case study and tie it to IQ/OQ/PQ.
ACTION ITEM: PRI Staff to add representatives from the following companies to the Process Validation Sub-Team: Philips, Flextronics
ACTION ITEM: PV Sub-Team to distribute list of questions to the Task Group and provide periodic high level updates (meeting minutes?)
ACTION ITEM: Prior to distribution of the validation questions to the Task Groups, add a few generic audit criteria regarding process validation to all new Task Group audit criteria (capability and evidence that it’s done).
ACTION ITEM: Training on process validation questions to be added to the 2-hour Medical Device training for auditors approved via Nadcap.
3.3.1 Need for New Industry Standard on Process Validation (similar to AS 9102?)
During the last sub-team meeting, there was a question regarding whether a new consensus standard should be developed on process validation. The MMC agreed that a standard is needed, and that volunteers should begin working with an appropriate standard development organization. Potential SDOs include ASTM and AAMI.
Chris Cook (DePuy Synthes) is the point of contact for this activity.
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3.3.2 Case for Quality
With recent changes at FDA CDRH, this activity may move faster. Steve Niedelman participates on the Metrics committee – there is a lot of industry participation.
Outcomes of MedAccred efforts will be presented by Steve Niedelman to MDIC on 20May15 in DC.
Advamed is still continuing work on the Case for Quality sub-group. Ravi has been keeping them up to date on MedAccred and its progress. There is no formal linkage at this point, but would like to see a MedAccred reference or a link to the website. MedAccred should also be considered to be included in the Audit program.
ACTION: Ravi Nabar to determine if a MedAccred update can be given to the AdvaMed sub-team on 25Jun15 or sooner.
ACTION: Steve Niedelman to follow up with MDMA.
3.4 Software Validation
Jon Steffey gave a status update on eAuditNet and the software validation requirements. For more details, please see the attached presentation.
Practices have been captured in a new software development procedure and a new matrix for containing validation records and evidence has been developed and is progressing. Upcoming activities will include finalization of the procedure and matrix, along with a proposed Master SRS for historical validation of the system.
The SRS will be completed by Q2 2015 and the software fully validated by Q3 2015.
Software must be fully validated before approaching the FDA again.
4.0 ROLLING ACTION ITEM LIST (RAIL) REVIEW
The new action items assigned during this meeting were reviewed.
ADJOURNMENT – 13-May-2015 – Meeting was adjourned at 5:00 p.m.
Minutes Prepared by: Kellie O’Connor, [email protected] Justin McCabe, [email protected]
