innovating critical process manufacturing oversight...it is a ctq for production and process...

© Performance Review Institute


Innovating Critical Process Manufacturing Oversight

Medical Device Quality Congress - March 16, 2016


The Real Connection between Operators and Patients

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The True Value of Our Work

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THE CONNECTION TO OUR PATIENTS

Baby Amillia Video.wmv


MedAccred: The Solution

An industry-managed critical process supply chain quality program

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Reduces Risk Improves Patient

Safety Assures Quality

Products

Administered by the Performance Review Institute (PRI), a not-for-profit trade association,

on behalf of leaders in the Medical Device Industry

© Performance Review Institute 5

MedAccred audit is NOT a General Quality (QMS) audit It is a CtQ for Production and Process Assessment

In D

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Quality Systems Audit

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General Quality Focus

“1 mile deep on the

critical process, 1

inch wide on the

quality system”

“1 inch deep on the

critical process, 1

mile wide on the

quality system”


How did MedAccred Start?

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2010

2012

Industry Roundtable,

Chicago 2015

First accreditation issued

2013

First Meeting with FDA


Inspired by 25 Years of Aerospace Success

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Over 95% of major

global OEMs subscribe

Over 7,500 active Nadcap

accreditations globally

Over 250 SME auditors

17 critical processes

PRI administers the Nadcap critical process audit and accreditation program

on behalf of the global aerospace industry


Delivering Results

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Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9

No

. o

f Q

ua

lity

Defe

cts

Nadcap OEM Subscriber CtQ Results

Suppliers

Internal OEM



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2010

2012


Chicago 2015


2013



Initial Industry Roundtable Meeting

Roundtable held in 2012 to discuss the potential benefits

and applicability of a program similar to Nadcap for the

Medical Device Industry.

Original participating companies:

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• Abbott

• Baxter Healthcare

• Beckman Coulter

• Boston Scientific

• Brunk Industries

• DePuy Synthes

• GE Healthcare

• Medtronic

• Paragon Medical

• Philips

• Stryker

• Symmetry Medical

• Terumo Cardiovascular

• Zimmer



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2010

2012


Chicago 2015


for Heat Treating

2013



Does this look familiar?

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Supplier One

Supplier Two Supplier Three SUPPLIER

OEM/CM


Working Alone – Duplication

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Redundant Costly Time Consuming


Companies Actively Participating

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Aligning with Critical to Quality (CtQ)

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FOCUS: Ensure

compliance to critical

manufacturing process

requirements

Supplier Quality

Critical to Quality

FOCUS: Derived from

DFMEA/ PFMEA

FDA Case for

Quality

FOCUS: Improve

quality with a CtQ

focus

Support Support Support

Industry approach to Process Validation included in MedAccred audit criteria


AdvaMed - Case for Quality - MedAccred

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How does MedAccred work?

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Audit Criteria

Developed

Process Evaluation/

Improvement

Corrective Actions

Completed

Audit

Reviewed

Auditors Selected

Medical Device

Industry leaders

manage all key

steps Accreditation

Granted

Audit

Conducted


MedAccred Critical Process Technologies

Active

• Cable & Wire Harness

• Heat Treating

• Plastics

• Printed Circuit Board

Assemblies

• Sterilization

• Welding

Future (potential development)

• Assembly

• Batteries

• Casting / Forging

• Chemical Processing

• Cleaning

• Coatings

• Counterfeit Parts

• Electronic Displays

• Fluidics

• Machining

• Material Testing

Laboratories

• Measurement / Inspection

• NDT

• Optics

• Packaging

• PCB

• Power Sources

• Raw Materials

• Reagents

• Software


… reaching further down the supply chain,

Through MedAccred, the industry is…

My Direct

Suppliers

My

Supply

Chain

Tiers

1 & 2

Tiers

1 & 2

Tier 3

Tier 4

Tier 5

Improves the flowdown of OEM requirements

to the lower levels of the supply chain



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… streamlining requirements through technical Task Groups,

Multiple

Customer

Requirements


… conducting fewer but more rigorous critical process

audits with experienced technical experts,

Individual

Customer

Audits



… encouraging industry-wide involvement.


MedAccred

Management

Council

Task Groups

Cable & Wire Harness

Heat Treating

PCBA

Plastics

Sterilization

Welding

Supported by quality and

technical training

OEMs

CMs

Suppliers


Participation in MedAccred Teams

Sterilization Task Group Process Validation Sub-Team MedAccred Management Council

Baxter, Principle Engineer – Sterility Assurance

Abbott, Process Validation SME Abbott, Quality Program Manager Nypro Healthcare, Global Director of QA/RA

Becton, Dickinson & Co, Sr. Dir. Global Sterilization Services

Celestica, Technical Director Baxter, Supplier Quality Manager Paragon Medical, Quality Manager, I&I

Becton, Dickinson & Co. , WW Mgr Sterilization Tech

Flextronics, VP, Global Quality Becton, Dickinson & Co., Sr. Dir. Global Sterilization Services

Philips, Head of Supplier Quality Assurance

DSM Biomedical, Director of Quality Flextronics, Sr. Dir. HrS Quality Engineering

Boston Scientific Corporation, Senior SQE

Plexus Manufacturing Solutions, Supply Quality Manager

Flextronics, VP, Global Quality Global Technologies, Director of Corporate Quality

Celestica, Technical Director, RAC Sanmina, VP of Quality and Regulatory Affairs

Flextronics, Quality Director Johnson & Johnson, Sr. Quality Engineer CSTM/CBB

Flextronics, VP, Global Quality Siemens, Director, Quality

Johnson & Johnson, WW Sterilization/ Micro Mgr.

Medtronic, Quality Assurance Manager GE Healthcare, Supplier Quality Manager

Solar Atmospheres, Corporate Quality Manager

Philips, Sr. SQ Audit Manager Paulo Products, Director of Quality Global Technologies. CEO STERIS, VP, Chief Compliance Officer

Synergy Health/STERIS, Sr. Dir., Global Quality & Regulatory

Philips, Sr. Director, Supplier Quality Management

Johnson & Johnson, Sr. Director Supplier Quality

Synergy Health/STERIS, Sr. Director, Global QA/RA

Stryker Corporation, Sr. Clinical Sciences Manager

Solar Atmospheres, VP, Corporate Quality Kimball Electronics, Quality Manager Stryker, Associate Director, Corp. Supplier Controls

Stryker Corporation, SQE/Microbiologist

Synergy Health/STERIS, Sr. Dir, Global Quality & Regulatory

Lake Region Medical, Director of QA Techmetals Inc., Director of Quality

PRI, Program Manager, Sterilization PRI, Sr. Specialist, Business Development Medtronic, VP Contract Manufacturing

Tecomet, Global VP QA & RA

Merz, VP, Quality Operations Vention Medical, VP, Supply Chain

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Additional Supplier Perspectives on MedAccred

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• Heat treating is a secondary process performed on medical

device components and parts at hundreds of suppliers around

the world.

• Without an industry-managed oversight program to ensure the

technical competency required in special processing, problems

can arise anywhere.

• Heat treatment specifications in the aerospace industry are

more stringent and standardized than in the medical industry,

where lives are on the line.

- Heat Treating


• Medical device companies need to:

• Understand that simply citing a material

specification and hardness measurement on

a drawing is inadequate heat treat process

control

• Through MedAccred:

• OEMs identify and oversee the stringent

parameters that a heat treater must follow in

order to provide the end user with a quality

product.

- Heat Treating


• Temperature uniformity surveys ensure

that temperatures remain consistent in

all areas of a furnace hot zone.

• Industry standards are defined for how

and when to run a temperature

uniformity survey to eliminate variability

and ensure product consistency.

One Unique Aspect to the MedAccred Program - Pyrometry


• Industry-accepted, consistent, rigorous technical requirements

lead to:

• process discipline

• greater operational efficiency

• continuous improvement

Supplier Perspective - Benefits

…resulting in higher quality and lower overall cost


• Custom wire harness manufacturer

• Located in Spring Lake, Michigan

• Serving the medical industry for more than 25 years

- Electronics


MedAccred Journey

• Joined the Cable & Wire Harness Task Group in late 2013

• Participated in the task group, alongside OEMs and CMs,

representing supply chain interest, in the audit criteria development

• Hosted Proof of Concept Audit in March 2014

• Multiple OEM representatives and PRI Staff Engineer present

• Prepared for over one year for our MedAccred audit


MedAccred Accreditation Audit Cable & Harness Assemblies

• MedAccred audit is a 4 day intensive process involving both

procedural and shop floor manufacturing process reviews


MedAccred Benefits for Customers

• Mitigates patient and business risk

• Drives process discipline resulting in improved quality and lower

overall cost

• Qualitative tool to help assess and select quality suppliers


In Summary With MedAccred, you will see…

• Fewer but more rigorous critical process

audits with experienced technical

experts

• Streamlined process requirements

focused on established industry

standards and manufacturing best

practices

• Enhanced quality of parts resulting in

fewer defects and most importantly

improve patient safety

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To get your company involved in

MedAccred or for more information

please visit:

www.medaccred.org

Concluding Thoughts

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THE CONNECTION TO OUR PATIENTS

http://www.medaccred.org/

innovating critical process manufacturing oversight...it is a ctq for production and process...

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