Minutes of a Roundtable Meeting of The

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Minutes of a Roundtable Meeting of the

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

31October2013 at the Millennium Hotel in Minneapolis, MN (USA)

1. Participants

1. Introduction

• Joe Pinto welcomed participants to the meeting
• Participants were reminded of PRI’s guidelines for antitrust compliance
• Participants introduced themselves

1. Task Group Report Outs

• Justin McCabe provided a summary of recent and future activity for the 5 technology Task Groups (Electronic Circuits, Cable and Harness, Heat Treating, Sterilization and Welding)
• Potential next Task Groups to form:
• Batteries and Power sources should be put on the road map, especially for conversation with FDA in December 2013. FDA will want to see what’s next.
• PCBs is also a prevalent issue in the industry
• Question: What is our message to the FDA?
• Building off of an existing successful program (Nadcap)
• What are the issues/gaps/etc. that will need to be resolved
• Lessons learned on both sides (Aero and MD) from PoC audits

1. MMC Sub-team Report Outs

• Rebekah Gandek provided an update on the MMC Sub-teams (Proof of Concept Audits, Program Documents and External Communications and Strategy)
• Proof of Concept Audits
• Electronic Circuits
• Task Group recommended that “PCBA” is too narrow a term and should be changed to “Electrical Circuits”
• Jason Clawson provided an overview from Sanmina’s perspective
• It was an intensive audit. A valuable experience.
• Flowdown of specifications was considered a gap
• Job audits – Huntsville was a strong plant. IQ/OQ/PQ was all in line. Traceability was not a concern.
• The more that the audit can be standardized for separate OEMs, the better for the supplier.
• Wants to see more conformance to a spec. Try not to deviate from this.
• Contract Manufacturer (CM) PCBAs – there is a wide range. Some just want to get the job done, but others will do a good job.
• Question: How do you pick a supplier that meets the OEM’s specific needs? Sanmina wants to know who are “capable” and those that are the “best” in a certain area in order to “Stratify” the supply base. This would be beneficial to them.
• Answer: Nadcap has stayed away from this because of the subjectivity involved. The program Subscribers have all of the audit data and can make the decision based on the audit results.
• Concerned about increase cost in aligning with Nadcap standards. Just want to meet MD standards, otherwise would be wasting money.
• MD industry will need more QMS-specific questions in the audit checklists. Aerospace is comfortable with AS9100 and so checklist questions are not as specific to QMS.
• Electronic Circuits opportunity: E.g. Aerospace is using J-standards and MD is using IPC. Perhaps the MD industry should consider shifting over to J-standards, since it is aerospace best practicel. This should be the job of the TGs to decide. (Baxter really saw the value in this)
• Philips’ vision for where MedAccred fits in to supplier approval. 3 blocks:
• QMS Certification–Rx-360 and/or notified bodies fit in here
• Process Certification – MedAccred fits in here
• Part Certification– Performed by OEM
• Heat Treating PoC
• High-level overview provided. Overall, the PoC was successful.
• Question: What would be the impact to MD industry of implementing a requirement for AMS2750?
• Answer: Doesn’t think that it would have any negative impact (Accellent)
• Communication between the OEM and Supplier is very important. Suppliers may be using this standard, but OEMs might not be aware of it.
• The industry should move towards “FDA-recognized” consensus standards. If they are not available, then look at Aerospace and other industry standards.
• ACTION: Need to make sure that TGs are doing this.
• Program Documents Sub-Team
• Additional agenda items to discuss later
• The final draft of PD1300 was presented. Goal for today is to agree on next steps for the Program Document.
• External Communications and Strategy Sub-Team
• A meeting between MedAccred and FDA has been scheduled for 3 December 2013

1. Rx-360

• Matt Anderson provided an overview or Rx-360 and their intentions for moving into the Medical Device space
• Rx-360 has no interest in creating competition between organizations
• Rx-360 wants to know how they can help MedAccred.
• Rx-360 lessons learned that could be shared with MedAccred:
• Figured out how to get people in the healthcare industry talking and working together – experience with legal aspect
• Good relationships with partner organizations – could be a tool for pointing people towards MedAccred accredited suppliers
• Close relationship with FDA
• Existing infrastructure
• 30 member companies and 30 supplier companies – 80% have medical device legs of their business
• Has a mechanism for sharing audits.
• Rx-360 is more cGMP focused
• Rx-360 is broader than what was displayed in the Venn diagram (attached)
• Supply chain security
• Advocate (Lobby?) to change regulations at FDA
• Joe Pinto proposed using an IAQG/PRI type model for Rx-360. Matt Anderson said that this makes a lot of sense to him. He thinks it would be worth talking more about.
• There is precedence on the Pharma side – Insipients – IPAK (sp?). The sugar and salt suppliers developed a group called IPIA (sp?) that is conducted to a standard. Rx-360 and FDA recognize IPIA as a recognized insipient accreditation
• Matt Anderson thinks that this model would be familiar to Rx-360.
• Ravi Nabar agreed. There are no QMS mandatory requirements in the US. Suppliersdo not even have to have ISO9001.
• However, for the critical process suppliers, they won’t be mandated to have a specific QMS system. An audit checklist for component and sub-assembly space would be needed, similar to AS9100.
• Steve Niedelman sees these 2 programs as complementary and thinks there is value in collaborating. The industry as a whole would benefit from this and would think it is useful.
• Ravi Nabar – Process validation of quality aspects (CTQs) is what MedAccred would do. Rx-360 delivers compliance to cGMP, etc.
• Matt Anderson doesn’t think that these 2 things need to be separate. There should be a way to bring the 2 together.
• Craig Nelson does not understand what the ROI is for going with Rx-360. He’s still not sure what their value would be to an OEM.
• He sees the benefits of MedAccred in improving Stryker quality.
• REACH, RoHS, Conflict Minerals are new things that Rx-360 could help in the future.
• Matt sees Rx-360 as the “Best Consultants that MoneyCan Buy”
• Ravi Nabar – 3rd parties (e.g. TUV, BSI) can make surprise audits now at any tier in the supply chain, both QMS and product audits. He thinks that this is something that we can collaborate with Rx-360 on to try to mitigate.
• Steve Niedelman – What is the value that OEMs/suppliers see from Rx-360?
• Answer: Helps to get the attention of the supplier – engages them in the conversation
• From a FDA-perspective – Suppliers benefited because reduction # of audits. More clarity on the requirements.
• Sharing of best practices – Japanese tsunami example
• Craig Nelson – Industry had a titanium issue a few years ago. OSMA and Advamed helped with this and other issues.
• Ken Stopar – We have to see Rx-360 as more than just audits. Baxter has seen a lot of value from the shared audit program and the “cheap and very good consultants” they have access to.
• Next Steps:
• Continue discussions with Rx-360 on semantics and logistics. Determine what it would look like and the Value Proposition. Consider how ISO 13485 will fit into this.

1. eAuditNet SoftwareValidation

• Joe Pinto explained the enhancements that have been done to eAuditNet over time. Enhancements in Nadcap are currently not being utilized by the Transportation and Power Generation program, but this is something that MedAccred could take advantage of if desired.
• ACTION: Joe Pinto will present the list ofeAuditNet enhancements that have been made over the last 2 years at the next MMC teleconference.
• Question: Does eAuditNet have to be Part 11 Compliant? A: Yes, it must.
• Does every small change need to be validated? A: Yes. Each change has to be verified on how the change will impact the software. Even the code has to be validated.
• Rx-360 perspective of getting their audit software validated:
• Validation is very expensive. Re-validating is a timely and costly process.
• Includes change control that is validated.
• Access rights had to be built into their system. Customers wanted this aspect validated.
• Spent $900,000 for development and validation (most was for the validation aspect)
• Budget $250,000 yearly for maintaining the validation
• Philips is available to assist if needed. Kyle Cousin (Philips SME) is busy right now, so will not be able help at this time.
• DePuy SME will be available to assist after 16Dec13.
• Steve Niedelman knows of an outside source that can help, if we can’t get internal assistance. Possibly use the outside source for a final check.
• FDA does not like to hear the word “bug” and “glitch”. This is a big deal.
• Question: Is there Validation documentation available for changes to eAuditNet currently? Answer: No
• ACTION:PRI to send a communication to OEMs requesting Software Validation experts to meet with PRI Informatics departmentfor a discussion. We need to understand how changes would be validated. What is required? What does PRI have to do? (15Nov13)
• Steve Niedelman - A retroactive validation might be possible to the current eAuditNet system, but not sure
• Jim Ahle has an expert that does validation of supplier audits regarding software that could help.
• Rx-360 has created a QMS to assist with Software Validation. They might be able to share best practices. This is a benefit of collaboration between the two groups.
• Baxter is currently revamping their QMS system, so are very busy. Ken Stopar will ask them if they can share some lessons learned.

1. Program Document Overview

• Bekah provided a high level overview of PD1300
• The list of critical processes will be “fluid” and can be added to in the future as an editorial change.
• Vance Kyle – What if a supplier processes for Aerospace and Medical Devices? Will they need 2 audits? 90% of DePuy’s Heat Treat suppliers have Nadcap already.
• A: For now, yes. This is something that will need to be addressed in the future.
• Jim Ahle doesn’t think that it would be difficult to figure out the gap between the 2 checklists.
• Each industry would require separate job audits.
• ACTION:Change TG Quorum requirement in PD1300to a minimum of 3 in order to address the 2/3rds requirement when voting for failure
• ACTION:Distribute PD1300 to the MMC for a 30-day ballot by 4Nov13. MMC to return comments and feedback by 30Nov13 so that comments can be discussed and finalized at the 5Dec13 MMC meeting.

1. Subscriber/Supplier Definition

• Keep the 3 levels as they are (Subscriber, Sub-tier Subscriber and Supplier)
• Sub-tier Subscriber definition – The reason that Contract Manufacturer is used, is that the higher-level classification would be used.
• Steve has a problem with the Sub-tier subscriber as both a CM and a supplier. Would Subscribers lose the visibility of a Sub-tier Subscriber, since they are also a Supplier for other critical processes?
• Possible remedy: Have the supplier appear in both places: 1 as a Spec developer. 1 as Contract Manufacturer (not a Spec developer).
• Permissions will need to be managed appropriately. The data will need to be protected. The Supplier could give permission for the data to be shown to the OEM, but this would lower the value of the program.
• In Aerospace, this issue is covered by the Subscriber/Supplier relationship. For example, one Chemical Processing Supplier is assumed to be competing with other Chemical Processing Suppliers.
• We want to develop the system around the majority, not around the minority of unique situations.
• Rx-360 – Before the audit is conducted, whichever OEMs are sponsoring the audit will determine who will see the audit. This is agreed upfront. Whoever is not an Rx-360 member would need to get additional permission from the supplier and sponsoring organization to see the audit.
• Jason Clawson – These definitions are overly simplified and need to be further defined. The more we include in the document will help program participants to know who to flow this down to.
• We don’t want to set ourselves up for unattainable requirements.
• The data-protection aspect of the program needs further definition. This will be very important. Identify which OEM Subscribers that your data will be visible to.
• In-Vitro Diagnostics would fall into this category and is affected.
• ACTION: PRI to send the current Subscriber/Sub-tier Subscriber/Supplier definitions out to the MMC for feedback (4Nov13)
• ACTION: PRI to discuss with Informatics department how data protection will be addressed for MedAccred-specific needs. How to address Sub-tier Subscribers, etc.?
• Jason Clawson – suggested that we should redact data on the audit reports so that audit data could be shared more easily across the various levels.

1. Subscriber and Supplier Agreements

• Rebekah Gandekgave an overview presentation
• ACTION: PRI to send out the Subscriber and Supplier Agreements for feedback/comment(4Nov13)

1. Other Business

• No other new business was brought forward for discussion.

1. RAIL

• Justin McCabe reviewed the new ACTION items from today’s meeting.

1. Adjournment

• Joe Pinto thanked attendees for their continued participation and adjourned the meeting.