Management Strategies to Facilitate

Continual Quality Improvement

John O’Neill

Manager

Quality Systems Division

Boston Scientific Corporation

3 Point Strategy for Quality

Corporate culture embraces Quality

Continuous Communication & Improvement

Sustainability in mind at every stage

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.

Quality Culture

• Management Responsibility

• Strategy and Resources

• Measurement and Analysis

• Ensure Quality is Delivered

• Feedback

• Improvement

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?

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

Partnerships

Quality should have aligned partners

• Regulatory Affairs

• Market Surveillance

• Information Technology

• Document Control

• Training

• Others

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

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

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.

Ensure Quality input / feedback is

integrated with each sub-process

Resulting in:

Communication

Coordination

Compliance

Complete implementation of objectives

Avenues of Dissemination

Forums

Team Meetings

Site Visits

E-Mail

Power Point Tutorials

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

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

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.

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.

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.

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?

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?

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.

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

Role of the CaretakerKnows 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.

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.

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

Role of SME CommunityBe an active & productive participant

Think globallyEvaluate what might work at each site or all sites

Resolve issues & participate in projectsDeliver on promises

Be a Guide for change

Provide discussion on critical topicsKeep discussions & debates positive

Avoid diversions

Attend phone conferences and meetingsFor missed meetings, review meeting minutes for decisions and action items

Share information and best practicesVolunteer to lead and disseminate site / function practices

Communicate changes and progress through your business unit or function

Don’t monopolize forums and discussionsForums are venues to advance the organization and not dwell on business unit or

professional agendas

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.

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.

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.

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)

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.

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

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

Sustaining a User CommunityMaintain 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 engagedReview delegates to ensure that appropriate people are participating

Contact those chronically absent.

Maintain consistent meeting timing and time commitmentsInconsistent 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.

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

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

Questions

• Why do you… ?

• How do you… ?

• Where would I find… ?

• What if we… ?

• Should I… ?

• Has anyone… ?

Thank You

IVT Participants

Boston Scientific

Laura Owens

Steve Thistle

Marcus Gesner

James Handzo

Jacqueline Berretta