This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.

1. Management Strategies to Facilitate
Continual Quality Improvement
John O’Neill
Manager
Quality Systems Division
Boston Scientific Corporation

2. 3 Point Strategy for Quality
Corporate culture embraces Quality
Continuous Communication & Improvement
Sustainability in mind at every stage

3. Quality Objectives
Quality is about the customer throughout the process.
Obtain customer requirements and feedback to
continuously improve while satisfying regulations,
standards and best practices.
Quality systems identify, measure, control, and
improve the parameters within each function.

4. Quality Culture
• Management Responsibility
• Strategy and Resources
• Measurement and Analysis
• Ensure Quality is Delivered
• Feedback
• Improvement

5. Organization
• Does Quality report to the CEO?
• Does Corporate Quality trump Business Unit Quality?
• Is Quality comparable throughout Units?
• Is “QA” available and empowered?
• Are the Quality Systems under QA?
• Are the Quality Systems linked and coordinated?

6. Quality Policy
• Organization-wide Quality Policy
• Short, Simple and Action oriented
• Memorable
• Ties the individual to Quality (ownership)
• True
• Utilized. examples:
Cover Page, Footer, Badges, Posters,
Wearing Apparel, Justifications

7. Partnerships
Quality should have aligned partners
• Regulatory Affairs
• Market Surveillance
• Information Technology
• Document Control
• Training
• Others

8. Quality Document Hierarchy
Corporate Quality Policy
Corporate Quality Manual
Corporate Function Policies
Corporate SOPs
Corporate Work Instructions
Corporate Knowledge-Sharing Documents
Business Unit SOPs, WIs and KSDs

9. Critical Activities
Clearly map Requirements through Quality Systems
links to business processes.
QA maintains appropriate alignment to the businesses,
regions & functions it supports
Leverage the Corporate Quality Function and Field QA
organization relationship.
Corporate Quality identifies and sets standards.
Business Unit Quality ensures compliance

10. Identify and Map Sub-Processes
What are the key sub-processes in the Quality
Systems?
Example: Production & Process Controls may
have several sub-Processes including:
– Validation
– Operations
– Equipment
– Facilities
– Testing
– Packaging
– Labeling
– Etc.

11. Ensure Quality input / feedback is
integrated with each sub-process
Resulting in:
Communication
Coordination
Compliance
Complete implementation of objectives

12. Avenues of Dissemination
Forums
Team Meetings
Site Visits
E-Mail
Power Point Tutorials

13. Risk Management
Risk Management is a distinct Corporate Quality Function
Each Quality System embraces Risk Management
Risk Management is well-defined and applied uniformly
throughout the business units.
Each individual understands and applies Risk Management
principles

14. The Importance of Metrics
Critical Inputs:
Investigation / CAPA timing & volume
Batch Specification Failures
Customer Complaints
Audit Findings / Repeat Findings
Late deliverables
Cost Over-runs
Missing Data
Missed- Training / Training Deadlines

15. Documentation
The Corporate Document Caretaker
Is assigned to all Corporate documents related to their designated
system. Owns the document process and is responsible for its
execution.
Knows the Documentation process and impact on Compliance,
Change Requests, Revision Timing, Training, and Communication
throughout the organization.
Ensures documents are compliant to all applicable regulations. Is
aware of connections to other processes and documents within
function and across functions.

16. Quality Document Changes
Caretaker:
Understands reason for change & ensure changes align with the process.
Obtains critical support.
Involves key individuals as appropriate.
Develops a viable update plan. Communicate: what, when, how, and why.
Checks for potential integration with other efforts.
Determines how the changes will be sustained.
Approver on every Change Request for documents governing their process.
User Community:
Reviews and assures that business units maintain alignment with the
corporate process whenever a corporate document is created or updated.

17. Document Change Management
Where feasible, a Caretaker can have a positive impact by
grouping, sequencing and timing changes to documents
pertaining to their quality system.
Confirm the change is significant.
Can a change be grouped with other changes and included in an annual
update? Does it fit a designated criteria? (i.e. compliance impact, time
period, category of change)
When possible, non-compliance-related changes should be collected and
implemented with compliance-related changes.

18. Audit Support
Is there an Audit Support Group?
Are Caretakers and SMEs audit-prepared?
Do findings and “close calls” get disseminated?
Is there a “Lessons Learned” follow-up?
Are Audit Metrics kept?
Is there Audit Training and Mock Audits?

19. Where do you put the accent in CAPA?
Is it: CA’ PA, or is it: CA PA’ ?
Are the number of timely completions rising?
Is the “found effective” rate increasing?
In the Mature Phase, are the PA’s growing and
the CA’s shrinking?
Is there an effective Feeder System?

20. Quality Teamwork
Sustainable Quality is built on collaboration & shared ownership.
– Each quality system element may have a Corporate Caretaker,
Business Unit Function Owner and community of Subject Matter
Experts and Users in the business units.
– The corporate quality system Caretaker is responsible for ensuring that
their quality system is compliant. Users are responsible for their site’s
compliance, stability and consistency.
– There may also be Corporate Subject Matter Experts who provide
support and guidance to Caretakers and Users as well.
– Corporate Caretakers, SMEs, Site Process Owners, and Users work
collaboratively to establish, sustain and improve quality.

21. Critical Players
Caretakers use their knowledge of the regulatory environment to
support the users by creating appropriate guidance, tools & templates for
those who execute Quality Systems. They collaborate with the users to
ensure their Quality System meets the regulations and business needs.
Subject Matter Experts provide the support and guidance
necessary to transfer expert knowledge and skill to others. Some sample
SME qualifications include:
– Having technical training related to the subject matter and is qualified to train
others.
– Developer/Reviewer and/or previous experience with the subject area
– Functional manager or supervisor responsible for the subject matter

22. Role of the Caretaker
Knows Function needs. Acts as Consultant / Facilitator for
continuous improvement .
Maintains awareness of ever changing standards, best
practices and enforcement of standards.
Ensures compliant processes, balancing compliance and risk.
Monitors compliance input from audits and shares knowledge
gained.
Utilizes Quality metrics. Ensures system measurements are
accurate and clear for management reviews.

23. Role of Caretaker
Remains proactive to problems; is collaborative, inclusive and
team oriented.
Enables users to own their local systems and execution as well
as improvement processes. Assists Users through process
improvements.
Builds a User Community. Promotes and practices extensive
communication, learning and inter-site networking.
Creates tools, templates and guidance documents.
Manages Document changes, training content and
implementation timing.

24. Caretakers are not…
overly prescriptive
focused only on the needs of one Business Unit
overly complicated in their approach
indifferent to Problems
indifferent to the User’s needs
process dictators / mandate-givers
disconnected from other Caretakers, especially if their
systems interact

25. Role of SME Community
Be an active & productive participant
Think globally
Evaluate what might work at each site or all sites
Resolve issues & participate in projects
Deliver on promises
Be a Guide for change
Provide discussion on critical topics
Keep discussions & debates positive
Avoid diversions
Attend phone conferences and meetings
For missed meetings, review meeting minutes for decisions and action items
Share information and best practices
Volunteer to lead and disseminate site / function practices
Communicate changes and progress through your business unit or function
Don’t monopolize forums and discussions
Forums are venues to advance the organization and not dwell on business unit or
professional agendas

26. Role of Process Owner
Serves as conduit for transmitting issues to
Quality and leading the implementation of
mutually derived improvements and
solutions.
Ensures the participation of the Users and
business unit Subject Matter Experts.

27. Continuous Improvement
Continuous Improvement takes place
through the partnership between Process
Owners and Caretakers. They lead the
development and implementation of large
scale efforts to enhance the Quality
System, ensuring improved compliance,
effectiveness and efficiency.

28. Role of Users
Users are the primary consumers of the
Quality System. They take the
requirements, tools and templates and
implement them in support of the
businesses, regions, sites, & functions.
They own the execution of the Quality
System and ensure compliance. Not all
Users are in a Quality Assurance function.

29. Caretaker / User Assessment
Monitor & report on the performance of the
organization to established standards and
expectations. Consolidate assessment
information for general use in organization.
Help to facilitate relationships and
communication with Third Parties.
(Contractors)

30. User Communities
A User Community is all of the participants in a
Quality System function who interact to better
understand, improve and execute their function.
The establishment, operation and success of
the User Community is the responsibility of the
Quality System Caretaker.

31. Role of the User Community
Provide a common avenue of communication and information
Synergistically network the members and functions of the Community
Serve as a forum for discussion of issues and best practices
Disseminate Audit-related findings, Regulations, Standards, etc.
Distribute information regarding new procedures and guidances
Proactively and continually improve Quality

32. Launching a User Community
Begin with SMEs, Project Teams, Training Lists & Document authors
Expand through word of mouth and mention at various Forums.
Initiate a User Forum to meet regularly, across business unit locations
Disseminate critical information; discuss useful topics & audit findings.
Engage all Users through invitations to contribute / present topics
Provide a QS function e-mail address monitored by Corp. Quality Group
Conduct periodic site visits / site Forum broadcasts to engage locally
Solicit feedback for improvement from participants

33. Sustaining a User Community
Maintain communications
Establish SharePoint sites & folders
Publish meeting agendas and minutes, Seek agenda items
from the community
Track Action Items to completion
Use voting feature on e-mails for critical decisions. Communicate and
review results.
Communicate attendance to keep business units engaged
Review delegates to ensure that appropriate people are participating
Contact those chronically absent.
Maintain consistent meeting timing and time commitments
Inconsistent time and day of meeting discourages attendance
Obtain consensus before changing time and date
Establish a method to track, prioritize, & time implementation
of changes in processes, automation & procedures.

34. Measuring Effectiveness
Forum Attendance
Number of Topic Contributors
Degree of participation in Forum Discussion
Number of phone calls / e-mails with questions
Adoption of community consensus for site action

35. Summary
Weave Quality into Corporate Fabric
Map Regulations and Standards to Functions
Establish Quality System Caretakers & User
Communities
Build excellence into critical systems
(ex: Document Control)
Establish Quality Metrics to focus needs
Harness Feedback from Customers and Audits

36. Questions
• Why do you… ?
• How do you… ?
• Where would I find… ?
• What if we… ?
• Should I… ?
• Has anyone… ?

37. Thank You
IVT Participants
Boston Scientific
Laura Owens
Steve Thistle
Marcus Gesner
James Handzo
Jacqueline Berretta