MEDACCRED MANAGEMENT COUNCIL
OCTOBER 2015
CONFIRMED
CONFIRMED MINUTES
OCTOBER 01, 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.
THURSDAY, OCTOBER 01, 2015
1.0 OPENING COMMENTS
1.1 Call to Order / Quorum Check / Introductions
The MedAccred Management Council (MMC) Face-to-Face, WebEx & Teleconference Meeting was called to order at 8:15 a.m. EST, 01-Oct-2015, with the following representatives in attendance:
NAME / TITLE / COMPANY NAMERobert / Berger / Vice President, Contract Manufacturing / Medtronic
Sasha / Brishkowski / Supplier Quality Engineer / DePuy Synthes (J&J)
Ken / Chesney / Senior Director, High Reliability Solutions Regulatory/Quality/Engineering / Flextronics
Scott / Dauphinee / Supplier Risk Manager / DePuy Synthes (J&J)
Ed / Engelhard / Corporate Quality Manager / Solar Atmospheres
William / Ferris / Director of Quality / Techmetals / via teleconference
Scott / Goolsbey / Supplier Controls Manager / Stryker
Venky / Gopalaswamy / Vice President – Quality Systems and Supplier Quality / Philips HealthTech / via teleconference
Paul / Hugo / Director of Corporate Quality / Global Technologies / via teleconference
David / Mailes / Director of Quality / Paulo Products
Ravi / Nabar / Head of Supplier Quality Assurance / Philips HealthTech
Steve / Niedelman / Lead Quality System and Compliance Consultant / King & Spalding LLP
Chuck / Salvage / Corporate Director, Supply Chain / Vention Medical
Tamra / Sami / Editor-in-Chief, Quality and Enforcement / FDAnews
Rich / Trompeter / President / RTE Sales
PRI Staff Present
Jerry / Aston / Associate Program Manager, Heat Treating / PRI / via teleconferenceMark / Aubele / Senior Program Manager, Staff Engineer, Sterilization / PRI / via teleconference
Connie / Conboy / Director, Strategy and Business Development / PRI
Susan / Frailey / Lead Staff Engineer – MQS / PRI / via teleconference
Hannah / Godfrey / Senior Specialist, Business Development Europe, MedAccred Co-Lead / PRI / via teleconference
Julia / Markardt / Staff Engineer, PCBA and C&WH / PRI / via teleconference
Justin / McCabe / Senior Specialist, Business Development, MedAccred Co-Lead / PRI
Joe / Pinto / Vice President & Chief Operating Officer / PRI
Ian / Simpson / Associate Program Manager, Welding / PRI / via teleconference
Jon / Steffey / Program Manager – Informatics Solutions / PRI / via teleconference
1.2 Code of Ethics, Anti-trust and Conflict of Interest
The PRI Code of Ethics, Anti-trust and Conflict of Interest policy was reviewed. For more information, please view the video via the following link: PRI Code of Ethics, Anti-trust and Conflict of Interest Video
1.3 Site specific safety information was provided by Ravi Nabar.
1.4 Approval of MMC Minutes
1.4.1 Motion made by Ed Engelhard, seconded by Scott Goolsbey to approve 12-Aug-15 teleconference minutes. All in favor and minutes were approved.
1.5 Welcome
Venky Gopalaswarmy, Vice President – Quality Systems and Supplier Quality for Philips HealthTech formally welcomed all participants to the Philips facility and offered his support and encouragement for the continued development of the MedAccred program.
1.6 Connie Conboy reviewed the meeting agenda.
2.0 Accomplishments & highlights
Connie Conboy reviewed the embedded slides giving a summary of recent MedAccred accomplishments.
2.1 AMS 2750 – FDA Recognition Status
Initiative to obtain FDA recognition of the AMS2750 pyrometry standard (primary standard referenced in the Heat Treating Task Group audit criteria), is being spearheaded by Elizabeth George, Vice President Global Regulations & Standards for Philips HealthTech with support from Jerry Aston of PRI and Ed Engelhard from Solar Atmospheres.
Jerry Aston and Ed Engelhard have been providing information to the FDA regarding the importance of this standard to the medical device industry, and the heat treating process specifically.
An FDA Specialty Task Group is currently reviewing the information shared by Jerry and Ed. The MMC will be kept aware of any new developments.
3.0 Task Group Accomplishments
PRI Staff Engineers provided updates on the status for their respective Task Group activities and accomplishments.
See embedded slides for updates:
Discussion:
3.1 Plastics (PLA)
Area of critical importance for FDA, particularly injection molding. Task Group goal is to finalize audit criteria by the end of 2015.
It would be beneficial to get additional Suppliers involved to leverage their subject matter expertise in this area.
Vention Medical expressed interest in the open Vice Chair position.
3.2 Sterilization (STN)
Current Vice Chair, Donna Gallagher of Stryker is to be replaced by Rod Parker of Stryker pending approval from the Task Group.
3.3 Welding (WLD)
Discussion on soldering and whether it is covered by the Welding audit criteria. Some OEMs are seeing weaknesses in Soldering workmanship capabilities, specifically in PCBAs.
Soldering is not covered currently in Welding. They do have a brazing checklist, which could be expanded to soldering. Welding Task Group had planned to focus on resistance welding next but could change focus based on Task Group decision.
The PCBA audit criteria covers soldering. Auditors are looking for soldering criteria, purity, shelf life, etc.
3.4 MedAccred Quality Systems (MQS)
Task Group currently has a Vice Chair (Sasha Brishkowski – DePuy Synthes), but no Chair or Secretary.
Ravi Nabar felt that due to upcoming changes to ISO9001 and ISO13485 (moving to a more risk-based approach), it is important to have a Chair for this Task Group, and will nominate someone if needed.
ACTION ITEM: Ravi Nabar and Robert Berger to determine if there is someone who can support the MQS Task Group as a Chair or Secretary (31-Oct-15)
3.5 Batteries
Justin McCabe provided a summary of the Batteries Survey distributed to MMC to determine the need and potential support for the creation of a Batteries Task Group.
See summary of results in embedded presentation:
Discussion:
Steve Niedelman commented that premature battery failures and leakage are continuous and escalating issues for FDA
Ravi Nabar recently participated in a two day FDA public workshop on the subject of Batteries – the group developed a document which lists Critical to Quality characteristics for implantable batteries.
There was some discussion around how many battery manufacturers exist. Participants stated that there are many thousands. Most are located in Asia.
Are there are medical device-specific battery manufacturers? There was not a clear consensus from participants.
Participants agreed on 2 main focus areas:
· Rechargeable batteries
· Implantable batteries with Critical to Quality applications
MMC recommended approaching key OEMs using batteries:
· Philips HealthTech, Medtronic, St. Jude Medical, Boston Scientific, Baxter, Terumo, Hospira
· Companies who have had FDA recent actions related to batteries
Proposed Next Steps:
Participating companies to nominate Batteries SMEs to participate in an MMC sub-team to explore this area further.
ACTION ITEM: OEMs/CMs to provide names of Batteries SMEs to form an MMC sub-team that will explore viability of establishing a Batteries Task Group (31-Oct-15)
ACTION ITEM: Ravi Nabar to send Batteries document from his attendance at recent FDA public workshop on batteries to MMC for their information (31-Oct-15)
4.0 Outreach and research
Hannah Godfrey presented preliminary findings from research into FDA recall data and synergies with MedAccred critical process areas.
See embedded PPT for more details:
Discussion:
MMC appreciated this information and acknowledged its value to the program. It is difficult to come to any conclusions based on the raw data on FDA.gov, so it is helpful to see the connection to MedAccred.
Ravi Nabar proposed asking Suppliers about their defect rates. ISO asks this question. It was suggested it will be useful to see correlation of defect rates with use of MedAccred audits over time.
There was discussion around DFMEA and PFMEA and the potential need for MedAccred to address this area.
Robert Berger proposed the MMC considers developing an expertise in MedAccred around basic manufacturing to assess how effectively DFMEA and PFMEA are being used by suppliers.
Ravi Nabar summarized the proposal which is also an area recently discussed at Medical Device Innovation Consortium (MDIC):
3 areas to address:
· Design (responsibility with OEM)
· Design Transfer (flowdown) (this is where the issue is)
§ This is where the PFMEA can fail
§ Requires an answer to this question, “Did you execute a PFMEA?”
· If yes, then auditor checks to see if they are following the process
· If no, auditor asks if the supplier can still meet the specification
· Production (responsibility with Supplier)
§ MedAccred already addresses this aspect
Next Steps:
PRI staff will continue to work on FDA recall research.
Participants agreed to attempt to apply PFMEA within the work of the Process Validation sub-team, and also consider it in terms of the MedAccred job audits.
ACTION ITEM: Process Validation Sub-team to consider including additional general audit criteria covering PFMEA. (30-Nov-15)
The IMDRF guidance document on the control of products and services obtained from suppliers was discussed as a useful document for the MedAccred program stakeholders to be aware of. Steve Niedelman provided a link to the document, titled “Quality Management System – Medical Devices – Guidance on the control of products and services obtained from Suppliers”:
http://imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n17-guidance-on-quality-management-system-081211.pdf
5.0 eAuditNet Update
Jon Steffey gave a status update on eAuditNet and the software validation requirements.
See embedded PPT for more details:
Discussion:
It is important to have the software validated as soon as possible. The validation will be complete by Q4 2015.
Jon Steffey confirmed that the eAuditNet software is Part 11 compliant.
6.0 Process Validation UPDATE
Justin McCabe provided an update on Process Validation sub-team activities and next steps.
See embedded PPT for more details:
Discussion:
PRI Staff Engineer expertise in the area of Process Validation is limited. Suggestion to provide training to Staff Engineers, auditors, suppliers and others who would require this training.
Ken Chesney has Process Validation training materials that could be shared with the sub-team.
Ravi Nabar felt that Ed Engelhard’s Case Study was strong enough to potentially take to the FDA for approval.
Noted that FDA has been more rigorous in the area of Process Validation recently.
ACTION ITEM: Process Validation sub-team to develop and provide Process Validation training for MedAccred program stakeholders (Auditors, Suppliers, Staff Engineers, others) (30-Nov-15)
7.0 INTERACTIVE SESSION: FDA QSR PREAMBLE AND OTHER LEARNING TOOLS FOR PURCHASING CONTROLS
Scott Goolsbey led an interactive session on the FDA QSR preamble and other learning tools for purchasing controls.
See embedded PPT for more details:
8.0 2016 STRATEGY – OPEN DIALOGUE
Joe Pinto led a discussion on MMC strategy for continuing to grow and strengthen the MedAccred Program in 2016.
A summary of proposed strategies and tactics can be found in the enclosed slides:
8.1 FDA Recognition of the MedAccred program
Steve Niedelman recently met with Francisco Vicenty (FDA officer in the Division of Manufacturing and Quality, Office of Compliance, CDRH) at an MDIC meeting. Vicenty is very interested in the program. Bill McFarland (Director of the Division of Manufacturing and Quality, Office of Compliance, CDRH) and Francisco Vicenty also approached Ravi Nabar at the MDIC meeting. They have not forgotten about the Program and are interested to know the status.
Francisco Vicenty suggested FDA observe an audit to verify and validate the robustness of MedAccred. FDA would not use any of the information found.
Discussion:
This could provide additional credibility for the program. This could give FDA a further comfort factor. FDA is looking for “incentive” programs similar to MedAccred due to resource issues.
FDA is also looking at Rx-360 as one of their incentive programs.
Supplier would have to grant their permission to have FDA observe their MedAccred audit well in advance of their scheduled audit.
Will need to confirm that FDA will not use any information from the outcome of the audit.
Need to make sure MedAccred is as robust as possible before the FDA comes in to observe and ensure Process Validation is fully embedded in all critical process areas.
Timing – possibly Q1 2016?
Ideally, observation would be of a re-accreditation audit
There was a suggestion that FDA could possibly look at a Nadcap audit. Steve Niedelman felt that FDA would be most interested in observing a Medical Device supplier and not an Aerospace supplier.
ACTION ITEM: External Communications and Strategy sub-team to give further consideration to an FDA observation of a MedAccred audit (Q4 2016)
8.2 Increasing the Number of Audits
Some OEMs are already strongly encouraging their suppliers to get accredited.
Ravi Nabar suggested linking MedAccred to Case for Quality and other medical device industry initiatives such as MDIC and AdvaMed.
Proposal: MedAccred to reach out to leaders of MDIC, AdvaMed, MDMA, etc. and link our program to the specific initiatives they are working on.
ACTION ITEM: PRI to potentially work with groups such as MDIC, MDMA and AdvaMed to build further support for the Program (30-Nov-15)
8.3 Increasing the Number of New OEM Subscribers
It was agreed that MMC should focus on building the total number of OEM’s to 15 within the next year or two.
MMC proposed focusing efforts on companies that are currently actively participating, ensuring conversations are being had with representatives from the correct level within those companies.
Proposal: Schedule an Executive Forum for higher level individuals from currently participating manufacturers:
§ Potential agenda topic: FDA recall data
§ Timing: Q1 2016
Proposal: Determine the Premarket Approval (PMA) intersect with MedAccred.
Proposal: Can there be a new question to include into MedAccred TG audit criteria that asks for the defect rate?
§ Total # of Rejects / Total # Attempted
Proposal: Ed Engelhard suggested allowing Subscribing members participate in the next Solar Atmosphere’s re-accreditation audit (January 2016) and produce a formal report afterwards. Participating Manufacturers were also invited but Solar Atmospheres would not be able to disclose any MedAccred audit specific information to them.