MEDACCRED MANAGEMENT COUNCIL
MAY 2015
CONFIRMED
CONFIRMED MINUTES
MAY 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
Jim
DuBois
Ed
Engelhard
Corporate Quality Manager
Solar Atmospheres Inc.
Phillip
Brockman
President
Techmetals,
Incorporated
Lead Quality System and
Compliance Consultant
Director, Quality Assurance &
Regulatory Affairs
King & Spalding LLP
Sanmina Corporation
Via Teleconference
PRI Staff Present
Connie
Conboy
Director, Strategy and Business
Development
PRI
Susan
Frailey
Staff Engineer – MQS
PRI
Via Teleconference
MEDACCRED MANAGEMENT COUNCIL
MAY 2015
CONFIRMED
1.2
Hannah
Godfrey
Senior Specialist, Professional
Development Program Europe
PRI
Bob
Lizewski
Quality Manager
PRI
Justin
McCabe
Kellie
O’Connor
James
Phillis
Joe
Pinto
Jon
Steffey
Research & Development
Specialist
Program Coordinator, Nadcap
& MedAccred
Controller
Vice President & Chief
Operating Officer
Program Manager – Informatics
Solutions
Via Teleconference
PRI
PRI
PRI
PRI
PRI
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
2.0 Task Group
Activities - Status Update.pptx
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
MEDACCRED MANAGEMENT COUNCIL
MAY 2015
CONFIRMED
2-hour medical device-specific training course. The Task Group is also working to develop an
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.
MEDACCRED MANAGEMENT COUNCIL
MAY 2015
CONFIRMED
3.0
SUB-TEAM ACTIVITIES
3.1
Program Documents
MedAccred
Program Documents May2015 update.pptx
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?
MEDACCRED MANAGEMENT COUNCIL
MAY 2015
CONFIRMED
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
3.0 MedAccred
Sub-Team Updates.pptx
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.
MEDACCRED MANAGEMENT COUNCIL
MAY 2015
CONFIRMED
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
MMC eAuditNet
Update May 2015.pptx
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, koconnor@p-r-i.org
Justin McCabe, jmccabe@p-r-i.org