Program Overview & Value Proposition
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The materials provided online by Performance Review
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Content
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Value Proposition Objective
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Program Risk Analysis
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Current Medical Device Industry
Challenges
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Confidentiality of Information
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Case Studies
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Chronology
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Next Steps
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Benefits
•
•
Medical Device Industry
•
Medical Device Industry OEMs
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Medical Device Industry Suppliers
Scope
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•
Using MedAccred for Critical Process
Supplier Oversight
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Critical Process Areas of Interest
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Existing PRI Processes and Products
© Performance Review Institute
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Aerospace (Nadcap Subscriber Critical
Process Escapes)
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PRI Transportation & Power Generation
Program (OEM)
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Medical Device (Electronic Circuits –
PCBA Hypothetical)
Financials
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Subscriber Fees / Supplier Audit Pricing
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Template for Cost/Benefit Calculation
Additional Information
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PRI Contact & Future Meetings
Value Proposition 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.
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Current Medical Device Industry
Challenges
• Increased outsourcing and globalization of the supply
chain throughout the medical device industry, thereby
increasing the challenge of appropriate level of oversight
• Increased number of recalls attributed to supplier quality
issues
• Purchasing controls:
o is one of the top cited FDA-483 observations for
medical device quality system violations
o has been included as an element of several enforcement
actions (warning letters, consent decrees)
• Flow down of design requirements from OEMs to first-tier and
sub-tier suppliers is a critical issue affecting Quality & Safety
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Chronology
Date
Activity
December 2012
Industry roundtable #1 (5Dec12):
• 19 industry stakeholders from 15 different OEMs and Suppliers present
• Strong interest in a process-focused Industry-Managed Program expressed
February 2013
eAuditNet demonstration conducted (5Feb13)
Industry roundtable #2/Observation of Nadcap (aerospace) 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 (Proof of Concept Audits, Program Docs, External Comms. & Strat.)
June 2013
Program Management Council established with bi-weekly conference calls
5 Task Groups created (C&H, HT, PCBA, STN, WLD)
August 2013
Industry roundtable #4 (28Aug13)
Program branding: “MedAccred” name agreed by Management Council
September 2013
Proof of concept audit (PCBA) conducted
MedAccred website 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)
March 2014
Philips Healthcare became first subscriber to the MedAccred Program
Proof of concept audit (Cable & Harness) conducted
May 2014
DePuy Synthes (a Johnson & Johnson company) became the second MedAccred subscriber
June 2014
Stryker became the third MedAccred Subscriber
Presentation made to FDA Case for Quality Executive Forum
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December 2014
Plastics (Injection Molding, Resins) Task Group created
Next Steps for 2015
• Increase participation and commitment from the Medical Device
Manufacturers
• Increase participation and commitment to suppliers who provide critical
manufacturing processes
• Conduct MedAccred audits of suppliers
• Continue dialogue with CDRH and FDA Office of Global Operations
• Complete software validation of eAuditNet and update system as required
• Promote MedAccred to the wider Medical Devices industry
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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 25 year history of
successful performance and regulatory acceptance
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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
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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
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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
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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
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Benefits to Medical Device Industry
Suppliers
• 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.
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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)
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What is MedAccred and it’s Scope
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An industry-managed audit program that addresses critical manufacturing process
issues in the supply chain and reduces risk to patient safety by enhancing compliance to
critical process manufacturing requirements
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MedAccred is a tool for Medical Device OEMs to use in the oversight of their supply
base while they maintain ultimate responsibility for quality and compliance
•
MedAccred program provides in-depth, critical process, audits that are compliant and
consistent to accepted industry/technical standards and conducted by industry recognized
and approved Subject Matter Experts
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Scope of audit
o Critical, process-focused, technical audits with sampling of product audits to ensure
process capability to meet requirements
o Assesses effectiveness of suppliers’ Quality Management System (QMS) at the critical
process level (e.g. PCBA, Heat Treating, Welding, Sterilization, etc.)
o Audits based on robust core and OEM-specific checklists
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Using MedAccred for Critical Process
Oversight
OEMs:
- Establish requirements and
effective Flow-down
- Ensure oversight
SUPPLIERS:
- Maintain compliance to
requirements
MEDACCRED:
- Qualified Suppliers List (QSL)
- Sub-tier suppliers
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MEDACCRED:
- Provide audits to verify
compliance to requirements
- Issue accreditation
OEMs Establish Requirements And Provide Oversight
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For devices to meet the industry and FDA requirements, OEMs must:
o Define design specifications for the products to be manufactured
o Understand which of the manufacturing processes used in making the device
or its components are Critical to Quality (CTQ) and hence safety of the device
o Define industry standards and OEM specific requirements for these critical
processes
o Communicate (i.e. Flow-Down) these requirements to all levels of the Critical
Process Supply Chain
o Understand who are the Contract Manufacturers, as well as sub-tier suppliers
that are providing Critical Manufacturing Processes for the devices or their
components
o Define requirements for periodic oversight via the MedAccred program
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Suppliers: Critical Process Providers Must Maintain Compliance To
Requirements
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Critical Process Providers (Suppliers) are responsible for ensuring all requirements
(Industry Standards, OEM specifications, etc.) as flowed down by the OEM are met .
o This includes ensuring compliance to all critical process requirements.
o Receiving and maintaining MedAccred Accreditation is a mechanism for Suppliers to
demonstrate they have been verified as having the necessary processing capabilities
and controls to ensure compliance.
 Flow Down: A systematic approach that ensures OEMS specifications and
expectations of quality are effectively communicated to critical manufacturing
process providers for devices and device components at all tiers of the supply chain
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MedAccred: Can Provide Oversight To Verify Compliance To Requirements
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The MedAccred Audit verifies the Suppliers have the process capability, necessary equipment,
controls, qualified personnel, sub-tier controls, etc. and the ability to follow the process requirements
as defined by the OEM and/or industry specifications.
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Critical Process Task Groups, made up of Industry Representatives, create industry agreed audit
criteria which drive supplier process compliance to customer requirements.
•
Auditors review OEM requirements and ensure the supplier is in compliance
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Subscribing OEMs can maintain oversight and ensure effective flow-down of their requirements by
participating in the Critical Process Task Groups and the audit process.
MedAccred: Can Provide Oversight To Verify Compliance To Requirements
• For those Suppliers that outsource a critical manufacturing process,
the MedAccred QSL allows them selected accredited sub-tier
suppliers
• The MedAccred QSL (Qualified Supplier List):
• A publicly available list of accredited MedAccred Suppliers to specific
Critical Process technologies
o Display of all Audits/Certificates for a supplier
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Critical Process Areas of Interest
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Casting/Forging
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Non-Destructive Testing
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Chemical Processing
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Optics
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Cleaning
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Packaging
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Coatings
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Electronics
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Raw Materials
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Displays
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Re-agent
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Electronic Circuits - PCBAs
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Resins
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Power sources/supplies
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Composites
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Cable & Harnesses
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Injection Molding
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Fluidics
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Heat Treatment
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Machining
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Laser Etch
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Material Testing Laboratories
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Measurement/Inspection
© Performance Review Institute
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Sterile
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Sterilization
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Software
•
•
Hosted Services
Welding
KEY:
BOLD PRI currently has
checklists addressing
these Critical
Process/Product areas
BLUE
Active Task Groups as of
January 2015
Existing Nadcap Processes and
Products
Special Processes
Systems & Products
Non-Destructive
Testing
Coatings
Aerospace
Quality Systems
Electronics
Welding
Non-Conventional
Machining
Composites
Fluid Distribution
Systems
Chemical
Processing
Conventional
Machining as a
Special Process
Elastomer Seals
Sealants
Heat Treating
Surface
Enhancement
Materials Testing
Laboratories
Non Metallic
Materials Testing
Measurement &
Inspection
Non Metallic
Materials
Manufacturing
Future Processes
Raw Materials
The Medical Device Industry has expressed interest in these Critical Processes and Products
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Castings &
Forgings
Program Risk Analysis
• Risks of developing a program/not doing it right
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Not timely
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No critical mass
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Proof of Concept audits not showing much
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Cost could go up without critical mass
• Risks to implementing a program
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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
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Agency acknowledgement
• OEMs may still have to conduct special process audits
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Confidentiality of Information
Addressed in MedAccred Program Document PD1300:
• 1.1 describes the MedAccred program
“This Program Document shall govern the operations of the MedAccred Program.
This document establishes the policies for how MedAccred shall meet the
requirements defined in PD1000. MedAccred Management Council (MMC) and all
MedAccred Task Groups and committees shall operate in accordance with these
procedures and all referenced documents.”
• 4.4 describes the roles and functions around Task
Groups.
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Confidentiality of Information (cont.)
eAuditNet security features:
•
•
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eAuditNet implements operating procedures:
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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)
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Each user can only access audits/functions relevant to their company and roles
eAuditNet uses standard IT security best practices:
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All eAuditNet/program data is delivered over Secure Socket Layer (‘https’)
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All system activity is logged
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Audit data is stored behind multiple firewalls, and physical safeguards are in place
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PRI and SAE have regular information security audits:
• PCI compliance
• External penetration testing, etc
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Case Studies
• Aerospace (Nadcap OEM – Critical Process
Escapes)
• Transportation & Power Generation (OEM)
• Medical Device (Electronic Circuits - PCBA
Hypothetical)
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Aerospace OEM - Critical Process Escapes
Internal Data Provided by Nadcap Subscriber
Supplier SP Process
No. of Escapes
Internal SP Process
78%
decrease
2001
2002
2003
2004
2005
2006
2007
* An escape is where defective product has been shipped to the customer prior to
being identified as faulty
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2008 2009 as
of (6/09)
PRI 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)
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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)
Specific
root-causes
Product
failure/recall
Threat to life
& profits
• Supplier has incorrectly applied solder flux
• Ineffective cleaning
• 20,525 devices were recalled
• Contamination could have lead to inoperability
• 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
(1) Trautman, K. (2010). Purchasing Controls – Background & Examples.
Retrieved November 02, 2012, from FDANews.com
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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
17.1.14.C
17.1.15.C
Reflow Soldering
Are soldering defects including solder joint touchup identified, recorded and addressed in a continuous
improvement plan?
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.
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20.1.C
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Coatings and Encapsulation
Is there objective evidence of cleanliness verification?
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Subscription Fees
1st Subscribing
Year
New Subscribers
Program Subscription Fee
Program Development Fee
$90,000
Total Annual Subscriber Fees
$90,000
2nd Subscribing Year Onwards
1-5 Active
Subscribers
$60,000
6-10 Active
Subscribers
$55,000
>10 Active
Subscribers
$50,000
$60,000
$55,000
$50,000
Revised: 29Oct14
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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)
1 Day
2 Day
3 Day
4 Day
5 Day
Stand Alone Audits (includes travel costs)
Asia/Pacific& S.
N. America (Dollars)
UK (Pound)
America (Dollars)
$4450
£2975
$5100
$5700
£3800
$6350
$6950
£4625
$7600
$8200
£5450
$8850
$9450
£6275
$10100
Application Fee
EMEA* (Euro)
€4450
€5700
€6950
€8200
€9450
included
Follow-up Audits For Verification Of Corrective Action
1 Day
Each Added Auditor Day
ITAR/EAR Fee**
$5100
$1250
£2975
£825
€4450
€1250
N. America (excludes
US)
Asia, ANZ, S. America
UK
EMEA
$575
$1060
£685
€900
$4450
$1250
*EMEA – Europe, Middle East and Africa
**ITAR - International Traffic in Arms Regulations, EAR - Export Administration Regulations (Audits with
Export Control restrictions require a US citizen to travel to other regions. Hence, the additional fee to
cover travel costs).
NOTE: The above pricing model includes travel surcharges for Asia-Pacific and South American audits,
and for ITAR/EAR audits outside of the United States. These surcharges were shown as “expected to be
between USD1000 and 2000” in the initial cost structure shown from the beginning of the program.
Revised: 29Oct14
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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
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Additional Information
• Details on upcoming MedAccred meetings, and access
to supporting information on the program (including this
presentation), can be found on the MedAccred website:
http://www.p-r-i.org/other-programs/medaccred/
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Contact Details & Upcoming Meetings
Joseph Pinto
Executive Vice
President & Chief
Operating Officer, PRI
jpinto@p-r-i.org
+1 724 772 7175
Justin McCabe
Research &
Development
Specialist, PRI
jmccabe@p-r-i.org
+1 724 772 8693
Bob Lizewski
Manager Nadcap
Program Quality and
NUCAP, PRI
rlizewski@p-r-i.org
+1 724 772 8618
Upcoming MedAccred meetings:
• MMC Monthly Teleconference: January 14 at 10:30am - 11:30am EST
• MMC Face to Face Meeting: February 17 (all day) in Memphis, Tennessee – Memphis
Hilton
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