Quality in the Medical Device Industry –

And Beyond

Presented to:

American Society for Quality (ASQ)

Madison, WI Section 1217

September 13, 2016

Presented by:
Dale Thanig
Principal Consultant
Quality & Compliance Services
(608) 469-4406
djthanig@yahoo.com

Page 1
Outline
 Thank You
 Exercise for Tables
 Some History, What I Do and Don’t Do
 Disclaimers
 Trends I See
 QMS Tour
 Questions and Answers

Page 2
Table Assignment
 Each Table assign a Spokesperson
- the one who has been ASQ member the longest -
 Each person at the Table share: Who is the most
impressive person you have had at least 5 min to
talk to One-on-One?
 Share your choice with others
 Vote/debate to Pick ONE for your Table
 Can’t pick someone in your family
 Write the impressive name on your Table’s
“Sticky”.

Page 3
 Some History

Nuclear Senior Quality & Director Reg. Global Director of Principal

Position Quality Director Director of
Submarine Quality Test Affairs QMS Consultant
Director QA & RA Quality
Officer Engineer Manager
Madison & Milwaukee
Location Pacific Palo Alto Madison Chantilly Louisville
WI
Fleet CA WI VA CO

Organization US Navy Varian Nicolet Dynatech Ohmeda Datex-Ohmeda GE Healthcare Quality & Compliance
Marquette Associates Instrument Labs Medical Medical Services
Univ. Corporation Systems

1972 1976 1980 1984 1988 1993 1996 2001 2004 2007 2016

Recognition / Certs / Affiliations

B.S. Chief ASQ Board of Examiners - Acquisition Senior Management Notified Body
Mathe- Engineer/ Certified Malcolm Baldrige Team Leader Lead Auditor Award Lead Auditor:
matics Nuclear Quality National Quality ISO13485
Submarines Engineer Award MDD
ISO9001
Navy Lead Auditor CMDCAS
Achievement ISO Standards
Medal Guest Lecturer:
Medical College of Wisconsin &
Marquette University–Biomedical Engineering

Page 4
 What I Do Lately

Staying Connected /
Family & Friends
None of Your
Business QMS Auditing for
Manufacturers and
their Suppliers / FDA
Training and Inspection Prep.
Building Quality
Systems

Page 5
Quality Management System Standards & Regulations
Quality System Regulation (QSR) + Other FDA CFR’s
11 Electronic Records
801 Labeling
U.S. FDA - 21 CFR 820 803 MDRs
806 Recalls
812 IDEs
814 510(k)/PMA
Canadian Medical
Customers’ Needs Device Regulations + Other Countries
SOR/98-282 e.g. China, Japan, Australia, Italy . . .

ISO 9001:2008
ISO 13485 Standard Quality Systems – Generic Std
Quality Systems – Medical Devices
IEC 62304:2006
(ISO9001:2008 + add-ons)
Medical Device Software-
Software Life Cycle Processes
Risk Management
ISO 14971 ISO 14000
Environmental Std

European Law
Medical Device Directive
(MDD, 93/42/EEC)

Page 6
D. Thanig, June 2009
Quality Management System Standards & Regulations
Changes Coming Soon+

Canadian Medical
Customers’ Needs Device Regulations Other Countries
Always evolving MDSAP Process

ISO 9001:2015
ISO 13485:2016 Quality Systems – Generic Std
(not just ISO9001+ add-ons)

Medical Device Directive

MDr released at end of 2016

Page 8
What I Don’t Do

ᴓ 510(k)s to FDA

ᴓ Class 3 devices/PMAs

ᴓ UDI/UPC

ᴓ Pharma

ᴓ Endorse particular Data System Tools

ᴓ Look for work – It finds me, no website, no employees

ᴓ Fancy PowerPoints

Page 9
 Some Trends I See –
Affecting Quality Systems

 Mobile / Remote device applications

 Transition from Hardcopy to e-Docs or Web-based
QMSs
 Contract Manufacturing & Outsourcing
 “Virtual” companies
 Acquisitions driving changes
 FDA Inspection Process - QSIT & MDSAP

Page 10
 What is a “Quality” ?
The degree to which a set of inherent characteristics fulfills
requirements. ISO 9000:2005

Requirements may vary by product(s), customers and geography:

Feature Set Safety Ease of Use

Product Technology Product Compatibility

Compliance Profile

RELIABILITY $ Cost of Ownership $ Serviceability

Page 11
What is a “Quality Management System?”
(QMS)
“The organizational structure,
responsibilities,
procedures,
processes and
resources
for implementing quality management.”

“Management” emphasizes that the scope of a quality system

spans the entire organization, not just the Quality and
Regulatory departments.
Strong support by management is needed to ensure that the QMS
is effective and successful in supporting the business.

Think of the QMS as your company’s ‘Rule Book’.

Page 12
Quality Management Principles
 Customer Focus – Regulators are Customers too
 Leadership Involvement
 Responsibility defined at all Org. Levels
 Process Approach: Inputs ⇨ Outputs ⇨ Measures
 Ongoing Improvement of QMS and Product Quality
 Data Driven: Measure ⇨ Analyze ⇨ Improve ⇨ Repeat
 Mutually Beneficial Supplier and Customer Relationships

Page 13
Quality Management Principles

dolphins.jpg

Page 14
Quality Management Principles

Katie & Carlos-203.jpg

Page 15
 Relationship Between
the Requirements and your QMS

External Quality System

Your QMS
Requirements [QSR & ISO]

• Establishes requirements • Establishes your processes

• The Law or Expectation • Rules for The Way you

work,
Defines “WHAT” Defines “HOW”
you need to do you do it

Page 16
 ISO 13485:2003 Documented Procedure(s)
4.2.2 – Quality Manual
4.2.3 – Control of Documents
4.2.4 – Control of records
6.2 – Resources/Training (if regulations require)
6.4 b) Work Environment (if processes require)
7.3.1- Design and development
7.4.1- Purchasing process
7.5.1 Control of production and service provision 7.5.1.1 General requirements b)
7.5.1.2.3 Servicing activities (if processes require)
7.5.2.1 - Validation of the application of computer software
7.5.2.2 Sterility (if sterile devices)
7.5.3.1 – Product identification
7.5.3.2.1- Traceability
7.5.5 - Preservation of product
7.6 – Control of monitoring and measuring devices
8 Measurement, analysis, improvement (for statistical techniques if reg’s require)
8.2.1- Feedback
8.2.2 - Internal audits
8.2.4 Monitoring and measurement of product
8.3 – Control of non-conforming product
8.4-Analysis of data
8.5.1 Advisory notices
8.5.1 Adverse Events ( if regulations require)
8.5.2-Corrective action
8.5.3-Preventive action Page 17
 QSR/ISO - Roadmap
Quality System
Management Responsibility
Personnel / Training
Customer Complaints
Corrective and Preventive Actions
Statistical Techniques
Acceptance
Activities
Non Conforming
Product
Labeling/
Process Design Purchas- Product-
Packaging
Service
H, S, D and
Controls ing ion Installation
 Process ID and Traceability
IMT Equipment
Process Validation

Internal Audits
Documents
Records

Page 18
 Enforcement of QSR vs. ISO
FDA - QSR Notified Body –
INSPECTIONS ISO 13485:2003 AUDITS
Document Type Regulation Standard
Scope of Processes creating product destined Path to compliance with European
enforcement for US Market Medical Device Directive, accepted
by many other countries
Certification Inspection by authorized enforcers Audits by certification services;
Process of the Law limited consulting allowed

Form of Results Form 483 itemizing Violations of Audit report lists

Regulation; Non-conformities
Establishment Inspection Report
available
Terminology in Some specific terms Fewer terminology requirements
your QMS required/expected
e.g. DMR, DHR, DHF, MDR
Nature of Letter itemizing actions CAPA response to Non-
response conformities

Worst case Fines, Court Injunctions, other legal Lose certification temporarily,
scenario actions Improve QMS
Re-audit

Page 19
FDA “QSIT” view of a QMS
 QSIT = Quality System Inspection Technique
 FDA’s process-based method to inspect a manufacturer’s QMS

 QSIT identifies four high-priority subsystems

to look at:
 Corrective and Preventive Action (CAPA)
 Management Controls
 Design Controls
 Production and Process Controls
The subsystems inspected depends on the “Level” of
the inspection.
.

Page 20
FDA “QSIT” view of a QMS

Page 21
 FDA / QSR Inspection Process
 FDA usually gives a few days notice prior to inspection.
 Inspections usually cover CAPA and Management Controls plus
one or more of Production/Process and/or Design Controls.
 Inspections usually last 3-5 days with one inspector – if you are
in good shape and the inspector has no interruptions.

 Prepare for inspections by reviewing QSIT inspection protocol.

 Your QMS needs to reflect current practice and cover all of the
regulations.
 Possible Results:
 No issues  No Form 483
 Some issues  Findings documented on Form 483
 If deemed serious or firm is non-responsive  Warning Letter

 Follow-up Response by Manufacturer: Be prompt and complete.

Get to root cause(s). Go the “extra mile”.
Page 22
 QSR / ISO - Roadmap
Quality System
Management Responsibility
Personnel / Training
Customer Complaints
Corrective and Preventive Actions
Statistical Techniques
Acceptance
Activities
Non Conforming
Product
Labeling/
Process Design Purchas- Product-
Packaging
Service
H, S, D and
Controls ing ion Installation
 Process ID and Traceability
IMT Equipment
Process Validation

Internal Audits
Documents
Records

Page 23
Quality System and Management Responsibility

 Quality Manual, System and Culture

 Create a Table of how QMS procedures Map to external requirements
 Make the Quality Manual/Policy relevant for setting MEASURABLE
OBJECTIVES.
Don’t just reword the requirements in your Quality Manual.
 Culture must allow anyone to “stand in front of the truck” when
necessary

“The hard stuff is easy, the soft stuff is hard” – Roger Milliken

 Management Reviews
Not a review of the Quality Dept. but of the Quality SYSTEM
Strive to make “Quality” a topic for all Management Mechanisms.
 Integrate meetings with Strategy Deployment (Hoshin) and Company
Planning
 Take Credit for ALL related activities. Can be conducted in “pieces” to
avoid ‘Death by PowerPoint’
Page 24
Quality “Intelligence” – Management Behavior
Unacceptable Minimum Acceptable Best in Class
Maturity
Spectrum Activity/Behaviors (Scale 1-10)
1 2 3 4 5 6 7 8 9 10

Support
Quality No EOQ/EOY Lead Quality Culture
“Forget the Regs, Improvements to
Mindset “Winks” Development
get the product out” Compliance and
QMS
Don’t bring any
Daily Bad News. Engaged in Participate in audits Use Quality
“I don’t look good Management and Analysis of Metrics to drive
Activities
Skill, Expertise or Topic

in stripes.” Reviews Findings decisions on Biz

Realize Competitive
Quality The Regulations Aware of FDA and Standards and Regs
advantage through
Knowledge are Roadblocks Int’l Requirements are useful tools
Compliance

“Can’t Measure Continuous

Quality Fix the Big Drive Growth
Quality? Improvement via through Quality
Measures Problems
It’s too subjective.” effective CAPA

Quality Turn to QA/RA QA/RA has a Quality System Everyone is on the

Resources only when you’re seat “at the Integrated with “Quality” Team
in trouble. Table” Business Processes
* Adjust arrow ends to indicate your honest assessment of our business

You impact the Quality Culture

with your decisions every day Page 25
Quality “Intelligence” - Business Indicators
Unacceptable Minimum Acceptable Best in Class
Maturity
Spectrum Activity/Behaviors (Scale 1-10)
1 2 3 4 5 6 7 8 9 10

Quality is not Fix the Continuous Drive Growth

Management
measured BIG Problems only Improvement Through Quality
results seen

Continuous Recognized as
Every “Man” for Ad hoc
Employees Improvement partners in
Skill, Expertise or Topic

himself Team Efforts

Teams and Tools Growth

Inspection and Complying with Best Practices Other Companies

Processes Sorting only Regulations is enough Implemented Benchmark Us

Squeezed for Monitored for Partner in Product Stakeholder in

Suppliers Quality Success
Price only Development
Improvement

Customers Who are Respond only to Partner in Product Loyal – Delighted

They? their complaints Development with New Products

* Adjust arrow ends to indicate your honest assessment of our business

Most Everything We DO is Covered by our QMS.

Results are Driven by our Quality “Intelligence”.
Page 26
 Internal Audits

 Map Plans/Checklists to show all Requirements covered.

 Invest audit time consistent with your Process Profile.

 Do some Product Audits

 Adjust Plans to changes in product, processes and org.

 Use the QSIT checklist to practice for FDA

 Small Company? – Find a Partner Company

 Recruit Auditors outside of QA/RA and from other facilities.

 FDA cannot review internal audit reports

Page 27
More on Auditing
What they May Not Tell you in Auditor Class

Techniques
 Follow “trails” early and often

 Start at the end of a Process and go backwards

 Get out of the Conference Room

 Early ‘warning’ of Findings – Velvet Hammer

 Ask for key copies as you go along

 Shorthand helps

Page 28
Even More on Auditing
What they May Not Tell you in Auditor Class
Style / Attitude

∆ Be a Human Being

∆ Tell people Why you are there

∆ Give them a little space, but get to the Point

∆ No “Hotel Room” Findings

 Auditee: “Tell me something I don’t know.”

 Think about what you’re leaving behind for the:

next audit team and the CAPA System

Page 29
Resources / Training

 Hire good People

 Document Training Requirements

 When documenting Changes (ECNs) - capture

whether training is needed

 Define your methods of Training “effectiveness”

 Job Descriptions can help reduce record keeping

 Keep Performance Eval’s Confidential

Page 30
Design Controls

 Can be used as methodology for developing a PROCESS,

e.g PFMEA

 Matrix-out the various records

Design History File (DHF),
Technical File (‘design doss’ier’ from MDD)
Device Master Record (DMR)
leads to Device History Record (DHR)

 Invest in DESIGN INPUT documents (specifications) that have

customer input for ‘usability’.

Page 31
Design Controls

 Do Risk Management Planning early (ISO14971) using a full

tool box, FMEA / HA / Risk Assessment / etc.
 Identify and protect access to Confidential health information
 Include learnings from complaint history on similar products.

 Bring in key suppliers as development partners.

 Project Reviews may not be legitimate Design Reviews;

 Document “Design Reviews” for Process Changes

Page 32
Design Controls (cont.)

 Verifications and Validations.

Trace all Hardware and Software DESIGN OUTPUTS to their appropriate
DESIGN INPUT (traceability matrices)
Verification – we made the product right - INTERNAL view

Validation – we made the right product. - EXTERNAL view

 Control the “transfer“ of new designs into Production to ensure that

processes will be stable and produce consistently conforming
products.
 Design changes need to be assessed for changes in risk, effect on
product in the field and V&V’d.

Page 33
Design Controls – Project Effort

NEW

Cumulative
Man Hours

Old

Early Product
Phase Release

Page 34
 Acceptance Activities

Acceptance Activities

 Inspection has to happen only when you require it.

 100% Inspection ISN’T.

 Tailor your activities to the criticality of the parts. (risk-based)

Page 35
 Non-Conforming Material

Material rejects provide data for the start of CAPA efforts

Use-As-Is decisions need additional “regulatory” review

 Do you really need “The Cage”?

Page 36
Document & Records Controls

 Make quality system documents accessible and readable.

Sometimes “less is more”.

 QMS documents must keep pace with 5S/Kaizen decisions

 Conversely, 5S/Kaizen implementation cannot ignore regulatory

or customer requirements

 Validate new databases/tools for QMS related processes.

 Define what information must be retained for the Device History

Record (DHR). Include checks of Labels and Labeling.

 Establish record retention and disposal schedules.

 Control Electronic Records/Signatures per 21 CFR 11.

Page 37
Purchasing Controls

Quality Agreements in place for contract manufacturers and “critical”

suppliers.

“Critical” Suppliers may be subject to regulatory audits.

Supplier evaluations and Change Notification are required.

 Supplier Quality Issues are usually a 50 / 50 situation

Extend change notification and control process to suppliers;

particularly OEMs and contract manufacturers.

Page 38
Production & Process Controls

 Include the work instructions and procedures for

assembly, test and inspection as part of design
pilot builds/release
 Manufacturing equipment needs qualification,
maintenance schedules and records
 Some processes may need to be validated

 All test fixtures, including their software, need to

be verified and maintained and/or calibrated
 Validate quality system S/W - 21 CFR Part 11

Page 39
 Inspection and Test

 Inspection and Test results recorded in the DEVICE

HISTORY RECORD.

 Be clear on who has authority to release product for

shipment.

 Consider which components or assemblies need to be

tracked by serial numbers for possible future corrective
actions. TRACEABILITY

Page 40
 Feedback & Complaints

 The Customer is Always Right – “But some need more

Education than Others.”

 Establish Escalation paths

 Hold regular cross-functional meetings for tracking

 Need “Adverse Event/Incident” and “Advisory Notice/Recall”

Procedures to satisfy all regulatory requirements.

Page 41
 Corrective and Preventive Actions (CAPA)

 Main area for FDA Inspection 483 Findings

 Don’t fear documenting issues – can save you in an Inspection
 Use a CAPA Board
 Use many sources (Design, Manufacturing, Service, Audits,
Suppliers, Management Review meetings, 5S, etc.), not just
Complaints.
 Elements of Robust CAPA process:
 Analyze  Identify  Investigate  Determine Root Cause(s) 
Action Plan  Implement  Check Effectiveness Update Docs 
Communicate Progress  Cover in Management Review  Do it Again
 Similar to Plan-Do-Check-Act and DMAIC cycles
 Something has to change !

Page 42
Labeling/Packaging/Storage/Installation

 Labeling, Packaging, Handling, Storage, Distribution,

and Installation requirements need documentation.
Part of Transfer

 FDA now requires Unique Device Identification (UDI)

and/or Universal Product Codes (UPC)

 Product status identification can be via LOCATION

 Identify shelf-life sensitive products and rotate stock to

prevent aging.

Page 43
 Service

Servicing

 It’s a process too. (7.5 of ISO13485)

 Decide whether “routine” service calls are “complaints”.

 Plug Service and Sales people into the complaint system.

 Analyze the data. Normalize data to your “installed base”.

Page 44
Statistics

 A simple “Run Chart” is a statistical method and is

often appropriate.

 Sampling plans used need solid rationales and can be

changed based on analyzed data.

 Be careful when setting “thresholds” for quality metrics.

Page 45
 Medical Device Directive
Council Directive 93/42/EEC
key elements nnnn
Articles Annexes
1 Definitions 1 Essential requirements
9 Classification 2-7 Conformity Assessment
10 Vigilance (Incidents and 9 Classification criteria
Post market surveillance) 10 Clinical evaluation
11 Conformity assessment 11 Notified Bodies
15 Clinical investigations 12 CE marking
Document(s):
Technical File
Declaration of Conformity
EU Representative
Essential Requirements
Labels and International Symbols
Incident Reports (Vigilance)
Translations
 Canadian Medical Device Regulations
OVERVIEW

Pre-Market – Manufacturer
Classification, Safety & Effectiveness, Labeling, QMS,
Licence Application

Health Canada – Licensing Process CMDR

Assessment of Manufacturer’s Application vs.
CMDCAS

Post-Market – Manufacturer

Maintain Records: Report Problems:

Report Changes :
• Safety & Effectiveness • Mandatory Problem
• New QMS Certificate
• Distribution records Reports
•Licence Amendments
• Recalls
Questions / Comments

Page 48