Program Overview & Value Proposition
description
Transcript of Program Overview & Value Proposition
© Performance Review Institute
Program Overview & Value Proposition
Revision Date: 20 February 2014
1
© Performance Review Institute2
Content
• Objective• Background• Chronology• Benefits
• Medical Device Industry• Medical Device Industry OEMs• Medical Device Industry Suppliers
• Scope of Project• Critical Process Areas of Interest• Existing PRI Processes and Products
• Process Map• Timeline – High Level Summary• 2013 Meetings & Details
• Program Development Activity (Outside of Roundtable Meetings)
• Requests to Medical Device Industry Stakeholders
• Program Risk Analysis• Confidentiality of Information• Case Studies
• Aerospace (Airline Passenger Safety Trends)
• Aerospace (Nadcap Subscriber Critical Process Escapes)
• Transportation & Power Generation (OEM)
• Medical Device (Electronic Circuits Hypothetical)
• Financials • Cost Structure• Template for Cost/Benefit Calculation
© Performance Review Institute3
Objective
To demonstrate to the medical device industry the value of creating an industry managed supply chain oversight program (MedAccred) that will reduce risk to patient safety, assure quality products and compliance with requirements as they apply to critical processes.
© Performance Review Institute4
Background
• Increased number of recalls attributed to supplier quality issues
• Overall increased interest in outsourcing and globalization of the supply chain, thereby increasing the challenge of oversight
• Purchasing controls is one of the top ten cited FDA 483 observations for medical device quality system violations
• Purchasing controls have been the target of several enforcement actions (warning letters, consent decrees)
© Performance Review Institute
Date Activity
December 2012Industry roundtable #1 (5Dec12):
• 19 industry stakeholders from 15 different OEMs and Suppliers present• Strong interest in a process-focused IMP expressed
February 2013 eAuditNet demonstration conducted (5Feb13) Industry roundtable #2/Observation of Dallas Nadcap meeting (20-22Feb13)
March 2013 Value Proposition document created and released to industry
April 2013 Proof of concept audit (welding) conducted
May 2013 Industry roundtable #3 (15May13)Management Council sub-teams formed
June 2013MedAccred Management Council (MMC) established with bi-weekly conference calls5 Task Groups createdLOI signed by Philips
August 2013 Industry roundtable #4 (28Aug13)Program branding: MedAccred agreed by MMC
September 2013 Proof of concept audit (PCBA) conductedMedAccred webpage developed
October 2013 Proof of concept audit (Heat Treating) conducted
December 2013 Industry roundtable #5 (05Dec13)Program presented to FDA CDRH Dept. (03Dec13)
January 2014 Program presented to FDA Commissioners Level (27Jan14)
February 2014 Industry roundtable #6 (12Feb14)
Chronology
© Performance Review Institute6
Next Steps
• Increase participation and commitment from the Medical Device Manufacturers
• Increase participation from Suppliers who provide a Critical Manufacturing Process
• Conduct proof of concept (PoC) audits in four technology areas (Electronic Circuits, Electronics – Cable & Harnesses, Welding, Heat Treatment) – 3 completed YTD
• Task Groups to continue audit checklist development, auditor recruitment, etc.
• Continue to conduct regular Management Council face to face meetings and bi-weekly conference calls to provide status updates on sub-team and Task Group activity and continue program development momentum
• Continue dialogue with CDRH and FDA – Commissioners Level
• Signature of Subscriber Agreements
© Performance Review Institute7
Benefits to Medical Device Industry
• Promotes a philosophy of continuous improvement and a culture of patient safety and quality for all participants
• Enhances compliance and quality management system effectiveness throughout the industry
• Promotes best practices to assure patient safety and quality
• Promotes application of industry and technical standards/practices
• Provides an opportunity for collaboration between Suppliers and OEMs
• Improves visibility of industry requirements to sub-tier Suppliers
Similar program in aerospace industry has a 20 year history of successful performance and regulatory acceptance
© Performance Review Institute8
Benefits to Medical Device Industry (cont.)
• Promotes least burdensome approach by reducing redundant process audits by multiple customers
• Enables reallocation of resources to other areas requiring attention
• Provides real-time and consistent visibility of supply chain quality
• Aligns with FDA’s “Case for Quality” strategic initiative
© Performance Review Institute9
Benefits to Medical Device Industry OEMs
• Establishes stringent industry consensus audit criteria based on industry and specific OEM requirements that ensure compliance and quality of devices, reduce the risk to patient safety and will satisfy the requirements of all participants
• Conducts in-depth special process audits that are compliant and consistent to accepted industry/technical standards and conducted by industry recognized and approved Subject Matter Experts. • Covers 3 areas:
1. Assess effectiveness of Suppliers’ QMS at the special process level; 2. Audits based on robust core and OEM-specific checklists; 3. Process-focused Product Audits
© Performance Review Institute10
Benefits to Medical Device Industry OEMs (cont.)
• Provides greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g. FDA, ISO 13485, MDD, etc.)
• Identify and reduce risk of exposure to lower-quality Suppliers and reduction of costly recalls
• Provides early warning notification to OEMs of supply chain quality issues
• Provides complete visibility of audit results and corrective actions taken in a secure and retrievable format
• Reduces cost of non-quality• Reduces cost of compliance
© Performance Review Institute11
Benefits to Medical Device Industry OEMs (cont.)
• Releases OEM resources to focus on Supplier development opportunities and/or problem area resolution
• Improves flow down of OEM requirements to sub-tier Suppliers
• Makes the Supplier selection process more efficient
• Global supply chain visibility through a web based system to support and improve efficiency in industry managed auditing and accreditation system (eAuditNet).
• Supports procurement to identify accredited Suppliers (Qualified Supplier List)
• Supports Supplier risk management activity
• Creates a shared pool of trained, recognized and approved subject matter experts among OEMs
© Performance Review Institute12
• Provides consistent/standardized critical process audits accepted by the medical device industry resulting in fewer redundant onsite audits by multiple OEMs
• Can use accreditation to increase client-base and opportunities across the Medical Device Industry
• Enhances the Supplier’s compliance status
• Medical Device Industry-accepted and consistent technical requirements leading to process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost.
Benefits to Medical Device Industry Suppliers
© Performance Review Institute13
Benefits to Medical Device Industry Suppliers (cont.)
• Helps Suppliers develop a structured approach to special process and product
• Provides opportunity to participate in development of audit criteria and the accreditation program
• 85% of suppliers report quality improvements after accreditation, including reducing scrap rates, reworks, escapes and defective products (from aerospace survey data)
© Performance Review Institute
Critical Process Areas of Interest
• Casting/Forging• Chemical Processing• Cleaning • Coatings• Electronics
• Displays• Electronic Circuits - PCBAs****• Power sources/supplies**• Cable & Harnesses***
• Fluidics• Heat Treatment**• Machining
• Laser Etch• Material Testing Laboratories• Measurement/Inspection
• Non-Destructive Testing
• Optics• Packaging
• Sterile• Raw Materials• Re-agent• Resins
• Composites• Injection Molding
• Sterilization****• Software*
• Hosted Services• Welding*
KEY:BOLD PRI currently has
checklists addressing these Critical Process/Product areas
BLUE Active Task Groups as of February 2014
* Number of votes received by 22Mar13 Dallas Roundtable participants for conducting Proof of Concept audits
© Performance Review Institute15The Medical Device Industry has expressed interest in these Critical Processes and Products
Special Processes Systems & Products
Non-Destructive Testing
Welding
Chemical Processing
Heat Treating
Materials Testing Laboratories
Coatings
Non-Conventional Machining
Conventional Machining as a Special Process
Surface Enhancement
Non Metallic Materials Testing
Electronics
Fluid Distribution Systems
Sealants
Aerospace Quality Systems
Composites
Elastomer Seals
Castings & ForgingsRaw Materials
Future Processes
Measurement & Inspection
Non Metallic Materials
Manufacturing
Existing Nadcap Processes and Products
© Performance Review Institute16
StartWed 8/28/13
FinishFri 12/19/14
4th Quarter 2nd Quarter 3rd Quarter 4th QuarterInternal OEM Buy-inWed 8/28/13 - Fri 1/3/14
Draft Program DocumentsWed 8/28/13 - Fri 1/3/14
Conduct PoC AuditsWed 8/28/13 - Fri 3/28/14
Review PoC Audit Results for ValueWed 8/28/13 - Fri 3/28/14
Validate SoftwareWed 8/28/13 - Fri 6/27/14
Configure eAuditNet to support MedAccredWed 8/28/13 - Fri 6/27/14
(ASK) Assemble List of SuppliersWed 8/28/13 - Fri 1/31/14
Approach and gain buy-in from Regulatory Agencies Mon 9/30/13 - Fri 6/27/14
(ASK) OEMs sign Subscriber Agreements (Tue 10/1/13 - Fri 1/31/14)
Define Auditor Requirements/HiringMon 11/4/13 - Fri 6/27/14
Approach Industry AssociationsMon 11/4/13 - Fri 12/19/14
Approach broader Supply baseMon 1/6/14 - Fri 12/19/14
Rally external stakeholders for Program buy-inMon 2/3/14 - Thu 10/23/14
European and Asian OEM engagementTue 4/1/14 - Fri 12/19/14
(ASK) OEMs issue supplier mandates as applicableTue 4/1/14 - Fri 12/19/14
MMC Meeting (Pittsburgh, PA)
Wed 8/28/13
MMC Meeting (Minneapolis, MN)
Thu 10/31/13
FDA Meetings (CDRH and OGROP)
Mon 12/2/13 - Mon 3/31/14
MMC Meeting (Pittsburgh, PA)
Thu 12/5/13
Release MedAccred Program Document
(PD1300)Wed 1/1/14 - Mon 3/31/14
MMC Meeting (Anaheim, CA)
Wed 2/12/14
Seek FDA follow-up meeting/progress report
Tue 4/1/14 - Thu 5/1/14
Launch Supplier Support Committee
Tue 4/1/14
MMC Meeting (Cincinnati, OH)
Mon 5/5/14
MMC Meeting (Pittsburgh, PA)
Wed 9/17/14
MMC Meeting (Pittsburgh, PA)
Wed 12/3/14
6JAN14
Key
OEM Responsibility
PRI Responsibility
Joint Responsibility
MedAccred Development Plan (Dec 2013 – Q4 2014)
© Performance Review Institute17
StartWed 8/21/13
FinishFri 2/27/15
4th Quarter 2nd Quarter 3rd Quarter 4th Quarter 1st Quarter(STL) Checklist development
Wed 8/21/13 - Fri 3/28/14
(WLD) Ongoing checklist reviewWed 8/21/13 - Fri 1/31/14
(WLD) Define auditor requirements/hiringWed 8/21/13 - Fri 1/31/14
PoC (EC) Checklist reviewMon 9/30/13 - Fri 2/14/14
(EC) Define auditor requirements/hiring
Mon 9/30/13 - Fri 2/14/14PoC
Develop Task Group Operating Procedures as applicableTue 10/1/13 - Mon 9/15/14
(HT) Ongoing checklist reviewMon 10/21/13 - Tue 3/4/14
(HT) Define auditor requirements/hiring
Mon 10/21/13 - Tue 3/4/14
(WLD) Pilot audit of revised checklists
Mon 2/3/14 - Fri 6/20/14
PoC
(EC) Pilot audit of revised checklistsMon 2/17/14 - Mon 7/7/14
(CH) Ongoing checklist reviewMon 3/3/14 - Wed 7/9/14
(CH) Define auditor requirements/hiring
(HT) Pilot audit of revised checklistsWed 3/5/14 - Mon 8/4/14
Pilot Audit
(STL) Checklist refinementFri 5/2/14 - Tue 9/30/14
(STL) Define auditor requirements/hiringFri 5/2/14 - Tue 9/30/14
(WLD) Release checklists for supplier preparation
Mon 6/23/14 - Fri 11/7/14
(EC) Release checklists for supplier preparation
Tue 7/8/14 - Mon 11/24/14
(CH) Pilot audit of revised checklistsThu 7/10/14 - Wed 11/26/14
(HT) Release checklists for supplier preparation
Wed 8/6/14 - Fri 12/19/14
(STL) Pilot audit of revised checklists
Wed 10/1/14 - Fri 12/19/14
(CH) Release checklists for supplier preparation
Thu 11/27/14 - Fri 2/27/15
MMC Meeting (Minneapolis, MN)
Thu 10/31/13
FDA Meetings (CDRH and OGROP)
Mon 12/2/13 - Mon 3/31/14
MMC Meeting (Pittsburgh, PA)
Thu 12/5/13
(ASK) OEMs sign Subscriber Agreements
Mon 1/6/14 - Fri 1/31/14
MMC Meeting (Anaheim, CA)
Wed 2/12/14
(ASK) OEMs issue supplier mandates as applicable
Tue 4/1/14
Launch Supplier Support Committee
Tue 4/1/14
MMC Meeting (Cincinnati, OH)
Mon 5/5/14
MMC Meeting (Pittsburgh, PA)
Wed 9/17/14
MMC Meeting (Pittsburgh, PA)
Wed 12/3/14
6JAN14
Task Group Development Plan (Dec 2013 – Q4 2014)
Key Electronic Circuits - PCBA
Electronics – C & H
Heat Treating
Sterilization
Welding
© Performance Review Institute18
Program Risk Analysis
• Risks of developing a program/not doing it right• Not timely
• No critical mass
• Proof of Concept audits not showing much
• Cost could go up without critical mass
• Risks to implementing a program• Will find Suppliers that aren’t capable – increased exposure
• Could mean more work for OEM – short term stretch on resources
• Finding enough/the right SMEs to conduct audits
• Agency acknowledgement
• OEMs may still have to conduct special process audits
© Performance Review Institute19
Confidentiality of Information
Addressed in Nadcap Operating Procedures (NOP):
• NOP-001 describes the Nadcap program“These Operating Procedures shall govern the operations of the Nadcap Program. This document establishes the policies for how Nadcap shall meet the requirements defined in SAE AS7003. Nadcap Management Council (NMC) and all Nadcap Task Groups and committees shall operate in accordance with these procedures and all referenced documents.”
• NOP-002 describes the roles and functions around Task Groups.
© Performance Review Institute20
• eAuditNet implements operating procedures:
• Each Company has one (or more) administrator(s) who are verified by PRI before any other users can be associated with that Company
• Each user has unique credentials, and is only associated with a Company by that Company's administrator(s)
• Each user can only access audits/functions relevant to their company and roles
• eAuditNet uses standard IT security best practices:
• All eAuditNet/program data is delivered over Secure Socket Layer (‘https’)
• All system activity is logged
• Audit data is stored behind multiple firewalls, and physical safeguards are in place
• PRI and SAE have regular information security audits:• PCI compliance• External penetration testing, etc
Confidentiality of Information (cont.)eAuditNet security features:
© Performance Review Institute21
Case Studies
• Aerospace (Airline Passenger Safety Trends)
• Aerospace (Nadcap OEM – Critical Process Escapes)
• Transportation & Power Generation (OEM)
• Medical Device (Electronic Circuits Hypothetical)
22 *Data from Aviation Safety Network and NTSB
Aerospace (Airline Passenger Safety Trends)
1990-1994 1995-1999 2000-2004 2005-2009 2010-20120
200
400
600
800
1000
1200
1400
0
500
1000
1500
2000
2500
3000
3500
4000
4500
5000
138
45 31 30 30
11911226
813 807
615
0 0 2 21 4.3138
773
1800
3850
4705Accidents/Year
Casualties/year
PRI - Products Removed, Suspended, Recalled or Stopped
Number of Nadcap Audits/year
23
1990-1994 1995-1999 2000-2004 2005-2009 2010-20110
1
2
3
4
5
6
7
0
5000
10000
15000
20000
25000
30000
1.38
0.90.77
0.48
0.028
0.820.69
0.40.58
0
4.34
6.25
5.14
2.9
0.93
2.67
6.49
6.11
4.38
0.73
62.12 77.46 89.75 95.39130.89690
3865
9000
19250
28447
0 0 2 21 4.3
Major accidents/million hrs flown
Serious accidents/million hrs flown
Injury accidents/million hrs flown
Damage accidents/million hrs flown
Aircraft hours shown in Millions
Number of Nadcap Audits (cumu-lative)
PRI - Products Removed, Suspended, Recalled or Stopped
Since March 20, 1997, aircraft -10 or more seats scheduled passenger service have been operated under 14 CFR 121.
Definitions of NTSB Classifications:Major - an accident in which any of three conditions is met: 1. a Part 121 aircraft was
destroyed, or 2. there were multiple
fatalities, or 3. there was one fatality
and a Part 121 aircraft was substantially damaged.
Serious - an accident in which at least one of two conditions is met: 4. there was one fatality
without substantial damage to a Part 121 aircraft, or
5. there was at least one serious injury and a Part 121 aircraft was substantially damaged.
Injury - a nonfatal accident with at least one serious injury and without substantial damage to a Part 121 aircraft.Damage - an accident in which no person was killed or seriously injured, but in which any aircraft was substantially damaged.*Data from Aviation Safety Network and NTSB
Aerospace OEM - Critical Process Escapes
2001 2002 2003 2004 2005 2006 2007 2008 2009 as of
(6/09)
Internal Data Provided by Nadcap SubscriberSupplier SP ProcessInternal SP Process
No.
of E
scap
es
24
78% decrease
* An escape is where defective product has been shipped to the customer prior to being identified as faulty
© Performance Review Institute25
Transportation & Power Generation (TPG) Program – Fastener Example
• Event: OEM experienced a product escape due to a faulty fastener and were forced to make an expensive repair
• Included in OEM Recourse: Requested a PRI NDT audit for their fastener Supplier
• TPG Audit Results: NDT audit uncovered cracks not found during initial inspection and process control violations that would have prevented the cracks
• Pre-TPG Program: Focus was on certifying the component (product-centric)
© Performance Review Institute26
Medical Device Quality-Related Product Recall (Hypothetical)2010: FDA issues a Class II recall on an Automated External Defibrillator ¹.Root cause: Printed Circuit Board Assembly (Electronic Circuits)
(1) Trautman, K. (2010). Purchasing Controls – Background & Examples. Retrieved November 02, 2012, from FDANews.com
• Supplier has incorrectly applied solder flux• Ineffective cleaningSpecific
root-causes
• 20,525 devices were recalled• Contamination could have lead to inoperabilityProduct
failure/recall
• Although individual Supplier could resolve issue, the industry remains exposed
• Customers remain exposed to potential consequences
• Highly likely industry will face similar issues from other Suppliers
Threat to life & profits
© Performance Review Institute27
How would Nadcap address this issue?
Medical Device Quality Related Product Recall (Hypothetical) (cont.)
Root cause: Printed Circuit Board Assembly (Electronic Circuits)
Supplier has incorrectly applied solder flux Ineffective cleaning
Nadcap process compliance is used as a preventative measure:AC7120 Revision B – audit criteria for circuit card assembly
17.1 Reflow Soldering17.1.14.C Are soldering defects including solder joint touchup identified, recorded and addressed in a continuous
improvement plan?
17.1.15.C Is the cleaning method being used as per the procedure and is the maximum time permitted between reflow and cleaning being observed?
Audit Note: Maximum allowed time of 8 hours unless otherwise specified by customer or manufacturer’s recommendation.
20 Coatings and Encapsulation20.1.C Is there objective evidence of cleanliness verification?
Cost Structure
• Supplier Audit Pricing (per-audit fee including travel costs) Based on current auditor daily fee of $420 per day. Will be increased as Auditor fees and travel costs increase in subsequent years.
* A travel surcharge will be added (expected to be between USD 1000 and 2000) for Asia-Pacific and South American audits, and for ITAR/EAR audits outside of North America
Stand Alone Audits (includes travel costs) Americas & Asia UK (Pound) Europe (Euro)1 Day $4,450 £2975 €44502 Day $5,700 £3800 €57003 Day $6,950 £4625 €69504 Day $8,200 £5450 €82005 Day $9,450 £6275 €9450Application Fee included
Follow-up Audits For Verification Of Corrective Action1 Day $4,450 £2975 €4450Each Added Auditor Day $1,250 £825 €1250
1st Subscribing Year 2nd Subscribing Year Onwards
New Subscribers 1-5 Active Subscribers
6-10 Active Subscribers
>11 Active Subscribers
Program Subscription Fee $60,000 $55,000 $50,000
Program Development Fee $90,000
Total Annual Subscriber Fees $90,000 $60,000 $55,000 $50,000
• Subscription Fees
© Performance Review Institute29
OEM Cost/Benefit Template
• What number of Critical Process Audits currently performing?
• How many can be eliminated?
• What is the cost to conduct these audits?
• Travel/Time savings?
• Can the QMS audits currently being conducted by OEMs be reduced?
• cGMP compliance
• Intangibles• Draw from entire med-tech industry expertise
• OEM experts could observe audits conducted by Subject Matter Experts
© Performance Review Institute30
Get Involved
Regular meetings are held by the MedAccred Management Council to determine the future of the program.
If you wish to get involved in the program or have any questions about MedAccred, please contact:
Justin McCabe [email protected]
Rebekah Gondek [email protected]