BEYOND COMPLIANCE:

BUILDING AND SUSTAINING A

CULTURE OF QUALITY IN YOUR

MEDTECH COMPANY

ROUND TABLE INTRODUCTIONS

Bill Mazurek, President & Managing Director,

Maz-Tec & Associates L.L.C.

Kari Miller, Regulatory and Product Management Leader,

Pilgrim Quality Solutions

Aaron DeMent, VP of Global Quality Assurance,

Sterigenics L.C.

BUILDING & STAINING A CULTURE OF QUALITY

Forbes Survey results (review) 2 slides max here.

BUILDING & STAINING A CULTURE OF QUALITY

BUILDING & STAINING A CULTURE OF QUALITY

BUILDING & STAINING A CULTURE OF QUALITY

BUILDING & STAINING A CULTURE OF QUALITY

BUILDING & STAINING A CULTURE OF QUALITY

Survey says:

1. Setting a consistent quality message …

2. Linking your Company Quality Goal to your

Metrics …

3. Training and Developing needs a priority focus …

4. Self-aware Leadership (walking the talk when it

comes to quality culture and behavior) …

5. Transparency (open communication) …

Priorities for all companies:

1. Active Leadership yielding control, team shared responsibilities & ownership.

2. Effective Communication Goal Alignment, transparency, clean and concise.

3. Continuous Improvement – everything must be open and embraced to change.

BUILDING & STAINING A CULTURE OF QUALITY

Copyright © 2017 IQVIA. All rights reserved.

FMMC Symposium

May 15, 2018

Beyond Compliance:

Building and

Sustaining a Culture of

Quality

There’s Only One Way to Change Culture: One Behavior at a Time

13

Need to Think Globally about Quality

• Achievement of customer expectations through conformance to their requirements

• Patients are more informed • They expect more: more value, better quality, more service

• The identification, diagnosis and ultimately, the prediction and prevention of quality problems across the organization’s value chain

• Visibility throughout the Value Chain • Value chains are getting longer and longer • Includes the Demand Chain and the Supply Chain • Regulatory bodies monitoring extended Value Chain

14

Quality Transformation is a Journey

Decision

Common Language

Single Source of Quality Truth

15

Harmonization • Different than Standardization which is more of a one size fits all

• Harmonization takes into account: • Regional/Local Needs • Global Regulatory Needs • Products/Product Families • Processes • Based on Best Practices

At the heart of a harmonized process is a common DNA strand that is consistent and measurable across

the organization.

16

Common Language - Common Understanding

• Common Definitions, Common Measures

• Structured Data • Product hierarchies

• Organizational hierarchies • Internal

• Virtual

Properly structured data allows for aggregation and disaggregation of data at all levels in the organization.

17

Single Source of Quality Truth

• Data Transformed - Information Everyone Knows how to Interpret • Consistent

• Actionable

• Measurable

• Allow the organization to “see” and understand • Trending problems

• Trending efficiencies

• Opportunities for improvements

• Predictive

Making the Case for Transformation

• Speak the language of the business

19

Make the “Business” Case; Language the Organization Understands !

• Customer Satisfaction

• Operational Consistency and Efficiency (Excellence)

• Reduced Cost of Quality • Reduce Cost of Poor Quality 10% - 30% • Reduce Cost of Good Quality 1% - 13%

• Improved Metrics • OEE • Scrap • Rework • First Pass Yield

• Avoid Non-Compliance Penalties

• Warranty

• Field Actions/Recalls

• Products In Compliance

• New Product Introduction

• On Time Delivery

• Supplier Defects

• DPMO

• Cycle Times

20

The Case For Quality Culture Transformation

• Achievement of customer expectations • Repeat Business • Expansion Business

• The identification, diagnosis and ultimately, the prediction and prevention of quality problems across the organization’s value chain

• Ounce of Prevention is Worth a Pound of Cure • Improves the Bottom Line, does not Detract

• Operational Excellence

• Visibility throughout the Value Chain

• Top Line and Bottom Line Financial Impact

MAY 15, 2018

Beyond Compliance – Real Life Examples – Building a Quality Culture

MAY 8, 2018

CONFIDENTIAL 22

Global Network Supporting Customer Requirements

Challenge

Gamma Facilities

EO Facilities

E-Beam Facilities

42 Production Facilities – 7 Labs – 2 Corporate Offices

4 Continents – 12 Countries – 10 Languages

• Goals

• Global processes and procedure with acceptance of local culture

• Ongoing quality improvement while expanding physical footprint and volume

• Maintaining adaptability to changing regulatory landscape

CONFIDENTIAL

• Communication – Create the case for quality incessantly – up and down the organization

• Quality key Element of the Business Plan

Spreading The Message

23

CONFIDENTIAL

• Global Harmonization of all key systems and operational processes

• Quality System

• All major quality procedures

• Allowance of some local procedures that do not conflict with overarching procedures

• IT Systems

• Focus on availability in local language as necessary

• Flexible to address local laws and regulations

• Operations – Like procedures for like operations globally

• Customer Interfaces & Messages

Global Thinking

24

CONFIDENTIAL

• Metrics – Uniformly understood, fully transparent • Global – Appropriate for organizational performance

• Local – Aligned with global but specific to local situation - still largely harmonized among various local facilities though local metrics allowed

• Customer Facing – What is important to us internally should align with, but may not be fully identical to the customer view

• Cascading metrics based incentives at all levels of the organization

Talking the Appropriate Language for the Audience

25

0

1000

2000

3000

4000

5000

6000

7000 E-Beam Facility Performance - TQPR

2015 TQMR 2016 TQPR 2017 TQPR 2017 EB Goal

Excellence Level: 2000 ppm or one issue every 500 processes Excellence Level: 2000 ppm or one issue every 500 processes

Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb

QP 0.00 0.00 0.00 0.00 1.67 0.00 0.00 2.08 0.00 0.00 1.79 9.09 1.61 0.00 0.00 0.00 2.86 0.00 2.13 1.37 0.00 0.00 0.00 0.00

NC 0.00 0.00 0.00 0.00 1.67 0.00 0.00 0.00 0.00 0.00 1.79 4.55 1.61 0.00 0.00 0.00 2.86 0.00 2.13 0.00 0.00 0.00 0.00 0.00

DEV 0.00 0.00 0.00 0.00 0.00 0.00 0.00 2.08 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1.37 0.00 0.00 0.00 0.00

CMP 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 4.55 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

0.00

2.00

4.00

6.00

8.00

10.00

12.00

14.00

16.00

18.00

20.00

Qu

ality

Perf

orm

an

ce

CPO

Quality Performance Details - Mar 2016 to Feb 2018

QP NC DEV CMP 6 per. Mov. Avg. (QP)

QP = Sum of Nonconformance, Deviations and Complaints QP = Sum of Nonconformance, Deviations and Complaints

CONFIDENTIAL

• Senior Staff Level

• Monthly Meetings

• Approach Quality two ways in alternating fashion

• One Month - Quality presents their Initiatives and Programs

• Alternate Month – Operations VPs required to report on quality performance & challenges

• Provides a balanced approach between facilitators of the quality process and users of it

• Management Review

Spreading The Message at Every Level

26

Facility TQPR NC Rate Dev Rate Damage

Rate Complaint

Rate Int QA Audit

FDA Audits Other Reg Audits

ABC 210 0 0 210 0 C - -

DEF 1782 1711 3 71 298 C - DHMA - 2 NC

GHI 54 0 0 54 1780 - - -

JKL 6005 5759 15 243 10270 C 1 aud - No

483 -

MNO 2162 2162 0 0 288 U - -

CONFIDENTIAL

• Corporate / Facility Management Level

• Targeted two way communication focused on knowledge sharing

• QA / Ops Webinar – All plants – GMs & QA Managers minimum – discussion of what is important for the quality system

• Human Error – Monthly for all facilities by technology – GMs, QA Manager, Operations staff

• Two way communication

• Corporate & Plants report

• Maintenance – Monthly for all facilities – Analog to Human Error calls with Maintenance involved

• Validation – Monthly for all facilities – Analog of the above for validation

• Project related as necessary

Spreading The Message at Every Level

27

CONFIDENTIAL

• DEF-3641 / CA-2686

• DESCRIPTION: Parameter modification requested to validation Study Director in cycle gas dwell phase pressure upper tolerance to avoid potential overshoot.

• IMPACT: one validation run discarded of the study due to the parameter modification.

• INVESTIGATION:

• The specification was initially approved by the plant.

• Process of reviewing the proposed specifications did not cover all the conditions that may affect or perform adversely during the final sterilization process.

• Equipment capability was identified to be on the limit with the initially proposed specification, but the point was not discussed until the protocol, CSAs and cycles were already in process.

• CORRECTIVE ACTIONS:

• Create a cycle development checklist that will allow to compare existing cycles and identify potential issues / gaps

• Reinforce use of ECAT for analysis of equipment capabilities when developing new cycles (compare against existing cycles)

Example Shared Detail

28

CONFIDENTIAL

• In Plant

• Monthly Meetings – Hosted by management – covers metrics / quality projects / local quality challenges / required periodic quality training (GMP, GDP, etc…)

• Shift Level Meetings – Floor level with every shift change

• Formal and Informal

• Required coverage of quality topics

• Local Initiatives – Freedom for plants based on local needs and culture

Spreading The Message at Every Level

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CONFIDENTIAL

• Transparency and honesty in evaluation critical

• Surveys

• Company administered customer surveys

• 3rd party industry surveys

• Employee engagement surveys

• Customer Comments / Complaints / Feedback

• Regulatory Feedback

• Internal Feedback

Testing The Theory

30

12%

15%

9%

27%

6%

30%

0%

Detractors

Engineer

Mfg / Cust Svc

Other

Planner/Supply Chain

Purchasing

QA/Sterility

Sr. Mgmt

Total: 33