Management Strategies to Facilitate  Continual Quality Improvement            John O’Neill            Manager            Q...
3 Point Strategy for QualityCorporate culture embraces QualityContinuous Communication & ImprovementSustainability in mind...
Quality ObjectivesQuality is about the customer throughout the process.Obtain customer requirements and feedback tocontinu...
Quality Culture•   Management Responsibility•   Strategy and Resources•   Measurement and Analysis•   Ensure Quality is De...
Organization• Does Quality report to the CEO?• Does Corporate Quality trump Business Unit Quality?• Is Quality comparable ...
Quality Policy•   Organization-wide Quality Policy•   Short, Simple and Action oriented•   Memorable•   Ties the individua...
PartnershipsQuality should have aligned partners   •   Regulatory Affairs   •   Market Surveillance   •   Information Tech...
Quality Document Hierarchy    Corporate Quality Policy    Corporate Quality Manual    Corporate Function Policies    Corpo...
Critical ActivitiesClearly map Requirements through Quality Systems  links to business processes.QA maintains appropriate ...
Identify and Map Sub-ProcessesWhat are the key sub-processes in the Quality Systems?Example: Production & Process Controls...
Ensure Quality input / feedback is   integrated with each sub-processResulting in:  Communication  Coordination  Complianc...
Avenues of Dissemination  Forums  Team Meetings  Site Visits  E-Mail  Power Point Tutorials
Risk ManagementRisk Management is a distinct Corporate Quality FunctionEach Quality System embraces Risk ManagementRisk Ma...
The Importance of MetricsCritical Inputs:Investigation / CAPA timing & volumeBatch Specification FailuresCustomer Complain...
DocumentationThe Corporate Document CaretakerIs assigned to all Corporate documents related to their designatedsystem. Own...
Quality Document ChangesCaretaker:Understands reason for change & ensure changes align with the process.Obtains critical s...
Document Change ManagementWhere feasible, a Caretaker can have a positive impact bygrouping, sequencing and timing changes...
Audit SupportIs there an Audit Support Group?Are Caretakers and SMEs audit-prepared?Do findings and “close calls” get diss...
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 ...
Quality TeamworkSustainable Quality is built on collaboration & shared ownership.   – Each quality system element may have...
Critical PlayersCaretakers use their knowledge of the regulatory environment tosupport the users by creating appropriate g...
Role of the CaretakerKnows Function needs. Acts as Consultant / Facilitator forcontinuous improvement .Maintains awareness...
Role of CaretakerRemains proactive to problems; is collaborative, inclusive andteam oriented.Enables users to own their lo...
Caretakers are not…overly prescriptivefocused only on the needs of one Business Unitoverly complicated in their approachin...
Role of SME CommunityBe an active & productive participantThink globally     Evaluate what might work at each site or all ...
Role of Process OwnerServes as conduit for transmitting issues toQuality and leading the implementation ofmutually derived...
Continuous ImprovementContinuous Improvement takes placethrough the partnership between ProcessOwners and Caretakers. They...
Role of UsersUsers are the primary consumers of theQuality System. They take therequirements, tools and templates andimple...
Caretaker / User AssessmentMonitor & report on the performance of theorganization to established standards andexpectations...
User CommunitiesA User Community is all of the participants in aQuality System function who interact to betterunderstand, ...
Role of the User CommunityProvide a common avenue of communication and informationSynergistically network the members and ...
Launching a User CommunityBegin with SMEs, Project Teams, Training Lists & Document authorsExpand through word of mouth an...
Sustaining a User CommunityMaintain communications       Establish SharePoint sites & folders       Publish meeting agenda...
Measuring EffectivenessForum AttendanceNumber of Topic ContributorsDegree of participation in Forum DiscussionNumber of ph...
SummaryWeave Quality into Corporate FabricMap Regulations and Standards to FunctionsEstablish Quality System Caretakers & ...
Questions• Why do you… ?• How do you… ?• Where would I find… ?• What if we… ?• Should I… ?• Has anyone… ?
Thank YouIVT ParticipantsBoston Scientific  Laura Owens  Steve Thistle  Marcus Gesner  James Handzo  Jacqueline Berretta
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Management Strategies to Facilitate Continual Quality Improvement

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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.

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Management Strategies to Facilitate Continual Quality Improvement

  1. 1. Management Strategies to Facilitate Continual Quality Improvement John O’Neill Manager Quality Systems Division Boston Scientific Corporation
  2. 2. 3 Point Strategy for QualityCorporate culture embraces QualityContinuous Communication & ImprovementSustainability in mind at every stage
  3. 3. Quality ObjectivesQuality is about the customer throughout the process.Obtain customer requirements and feedback tocontinuously improve while satisfying regulations,standards and best practices.Quality systems identify, measure, control, andimprove the parameters within each function.
  4. 4. Quality Culture• Management Responsibility• Strategy and Resources• Measurement and Analysis• Ensure Quality is Delivered• Feedback• Improvement
  5. 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. 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. 7. PartnershipsQuality should have aligned partners • Regulatory Affairs • Market Surveillance • Information Technology • Document Control • Training • Others
  8. 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. 9. Critical ActivitiesClearly map Requirements through Quality Systems links to business processes.QA maintains appropriate alignment to the businesses, regions & functions it supportsLeverage the Corporate Quality Function and Field QA organization relationship.Corporate Quality identifies and sets standards.Business Unit Quality ensures compliance
  10. 10. Identify and Map Sub-ProcessesWhat 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. 11. Ensure Quality input / feedback is integrated with each sub-processResulting in: Communication Coordination Compliance Complete implementation of objectives
  12. 12. Avenues of Dissemination Forums Team Meetings Site Visits E-Mail Power Point Tutorials
  13. 13. Risk ManagementRisk Management is a distinct Corporate Quality FunctionEach Quality System embraces Risk ManagementRisk Management is well-defined and applied uniformly throughout the business units.Each individual understands and applies Risk Management principles
  14. 14. The Importance of MetricsCritical Inputs:Investigation / CAPA timing & volumeBatch Specification FailuresCustomer ComplaintsAudit Findings / Repeat FindingsLate deliverablesCost Over-runsMissing DataMissed- Training / Training Deadlines
  15. 15. DocumentationThe Corporate Document CaretakerIs assigned to all Corporate documents related to their designatedsystem. Owns the document process and is responsible for itsexecution.Knows the Documentation process and impact on Compliance,Change Requests, Revision Timing, Training, and Communicationthroughout the organization.Ensures documents are compliant to all applicable regulations. Isaware of connections to other processes and documents withinfunction and across functions.
  16. 16. Quality Document ChangesCaretaker: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 thecorporate process whenever a corporate document is created or updated.
  17. 17. Document Change ManagementWhere feasible, a Caretaker can have a positive impact bygrouping, sequencing and timing changes to documentspertaining 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. 18. Audit SupportIs 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. 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. 20. Quality TeamworkSustainable 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. 21. Critical PlayersCaretakers use their knowledge of the regulatory environment tosupport the users by creating appropriate guidance, tools & templates forthose who execute Quality Systems. They collaborate with the users toensure their Quality System meets the regulations and business needs.Subject Matter Experts provide the support and guidancenecessary to transfer expert knowledge and skill to others. Some sampleSME 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. 22. Role of the CaretakerKnows Function needs. Acts as Consultant / Facilitator forcontinuous improvement .Maintains awareness of ever changing standards, bestpractices and enforcement of standards.Ensures compliant processes, balancing compliance and risk.Monitors compliance input from audits and shares knowledgegained.Utilizes Quality metrics. Ensures system measurements areaccurate and clear for management reviews.
  23. 23. Role of CaretakerRemains proactive to problems; is collaborative, inclusive andteam oriented.Enables users to own their local systems and execution as wellas improvement processes. Assists Users through processimprovements.Builds a User Community. Promotes and practices extensivecommunication, learning and inter-site networking.Creates tools, templates and guidance documents.Manages Document changes, training content andimplementation timing.
  24. 24. Caretakers are not…overly prescriptivefocused only on the needs of one Business Unitoverly complicated in their approachindifferent to Problemsindifferent to the User’s needsprocess dictators / mandate-giversdisconnected from other Caretakers, especially if theirsystems interact
  25. 25. Role of SME CommunityBe an active & productive participantThink globally Evaluate what might work at each site or all sitesResolve issues & participate in projects Deliver on promises Be a Guide for changeProvide discussion on critical topics Keep discussions & debates positive Avoid diversionsAttend phone conferences and meetings For missed meetings, review meeting minutes for decisions and action itemsShare information and best practices Volunteer to lead and disseminate site / function practices Communicate changes and progress through your business unit or functionDon’t monopolize forums and discussions Forums are venues to advance the organization and not dwell on business unit or professional agendas
  26. 26. Role of Process OwnerServes as conduit for transmitting issues toQuality and leading the implementation ofmutually derived improvements andsolutions.Ensures the participation of the Users andbusiness unit Subject Matter Experts.
  27. 27. Continuous ImprovementContinuous Improvement takes placethrough the partnership between ProcessOwners and Caretakers. They lead thedevelopment and implementation of largescale efforts to enhance the QualitySystem, ensuring improved compliance,effectiveness and efficiency.
  28. 28. Role of UsersUsers are the primary consumers of theQuality System. They take therequirements, tools and templates andimplement them in support of thebusinesses, regions, sites, & functions.They own the execution of the QualitySystem and ensure compliance. Not allUsers are in a Quality Assurance function.
  29. 29. Caretaker / User AssessmentMonitor & report on the performance of theorganization to established standards andexpectations. Consolidate assessmentinformation for general use in organization.Help to facilitate relationships andcommunication with Third Parties.(Contractors)
  30. 30. User CommunitiesA User Community is all of the participants in aQuality System function who interact to betterunderstand, improve and execute their function.The establishment, operation and success ofthe User Community is the responsibility of theQuality System Caretaker.
  31. 31. Role of the User CommunityProvide a common avenue of communication and informationSynergistically network the members and functions of the CommunityServe as a forum for discussion of issues and best practicesDisseminate Audit-related findings, Regulations, Standards, etc.Distribute information regarding new procedures and guidancesProactively and continually improve Quality
  32. 32. Launching a User CommunityBegin with SMEs, Project Teams, Training Lists & Document authorsExpand through word of mouth and mention at various Forums.Initiate a User Forum to meet regularly, across business unit locationsDisseminate critical information; discuss useful topics & audit findings.Engage all Users through invitations to contribute / present topicsProvide a QS function e-mail address monitored by Corp. Quality GroupConduct periodic site visits / site Forum broadcasts to engage locallySolicit feedback for improvement from participants
  33. 33. 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 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 dateEstablish a method to track, prioritize, & time implementationof changes in processes, automation & procedures.
  34. 34. Measuring EffectivenessForum AttendanceNumber of Topic ContributorsDegree of participation in Forum DiscussionNumber of phone calls / e-mails with questionsAdoption of community consensus for site action
  35. 35. SummaryWeave Quality into Corporate FabricMap Regulations and Standards to FunctionsEstablish Quality System Caretakers & User CommunitiesBuild excellence into critical systems(ex: Document Control)Establish Quality Metrics to focus needsHarness Feedback from Customers and Audits
  36. 36. Questions• Why do you… ?• How do you… ?• Where would I find… ?• What if we… ?• Should I… ?• Has anyone… ?
  37. 37. Thank YouIVT ParticipantsBoston Scientific Laura Owens Steve Thistle Marcus Gesner James Handzo Jacqueline Berretta

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