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Transcript of ©2014 MFMER | slide-1 Unlocking a Quality Management System’s Potential – Key Components and...
©2014 MFMER | slide-1
Unlocking a Quality Management System’s Potential – Key Components and Self-
Monitoring Tools
©2014 MFMER | slide-2
Agenda
• Introduction to the Research shield at Mayo Clinic
• Circumstances that led us to a Quality Management System (QMS)
• Key components of a QMS
• Self-monitoring tools
• Control limits and defined escalation
©2014 MFMER | slide-3
Objectives
• Explain key components of an effective QMS
• Illustrate helpful tools that can be used to self-monitor
• Discuss importance of control limits and defined escalation processes
©2014 MFMER | slide-4
Mayo Clinic Research Shield
• Physicians actively engaged in research ~ 640
• Individuals certifying research effort > 4000
• Research space > 900,000 sq. ft.
• Grants and contracts > 4700
• In the top 25 NIH grant funding by institutions
• Active Institutional Review Board-approved human research studies > 8,900
• Research and review articles in peer-reviewed journals > 5,700
©2014 MFMER | slide-5
Research Funding Sources
TOTAL RESEARCH BUDGET
$634 million
Total extramural $386 million
Mayo institutional support $248 million
39%
EXTRAMURAL FUND-ING
Federal & state $304 million
Industry $44 million
Other extramural $38 million
79%
10%
61%
11%
©2014 MFMER | slide-6
Research Finance at Mayo Clinic
• Research Finance is an enterprise wide division with staff working in Arizona, Florida, and Rochester. The team is devoted to ensuring compliant financial processes for post award activity for all funding types.
• Organizationally in the Finance Department
• Research Finance has employees working across 7 functional teams
• Award Management• Award Compliance • Award Revenue• Cores• Program Services• Reporting• Quality
©2014 MFMER | slide-7
Mayo Clinic Research Finance Historical Staffing
• Staffing numbers• Pre Department of Justice (DOJ)
investigation – 2003 – 25 FTE
• Post implementation of controls and launch of QMS – 2008 – 100 FTE
• QMS additions and enhancement, Self-monitoring in place, Working Differently initiative – 2013 – 88 FTE
©2014 MFMER | slide-8
DOJ Investigation and Settlement
Whistleblower (qui tam) suit filed – Agents visit
DOJ press release and investigation closed
Mayo settled for $6.5M
Reviewed NIH funds spent from 1992-2003
November2003
May 2005
June 2005
November 2003 - May 2005
©2014 MFMER | slide-9
Transition
• In June 2005, NIH sent a letter of inquiry asking for compliance related information and assurances related to 4 areas:
• Cost Transfers• Financial Management Systems• Written Policies and Procedures• Roles, Responsibilities, and Training
©2014 MFMER | slide-10
Mayo Clinic Response (2005-2008) Building the Framework
• Conducted comprehensive gap analysis
• Identified opportunities for improved compliance controls
• Self-disclosed to NIH self-identified compliance issues
• Met with NIH officials in Bethesda, multiple times to provide comprehensive updates
©2014 MFMER | slide-11
Mayo Clinic Response (2005-2008) Building the Framework
• Executed 26 projects• Automation• Policies & Procedures• Roles & Responsibilities• Tools
• Implemented new Enterprise Resource Planning (ERP) system, including Grants Management module
©2014 MFMER | slide-12
Strengthening the Framework (2008-2013)
• In 2008, adopted a Quality Management System, modeled after International Organization of Standardization (ISO) framework
• Cornerstones remain; • Added continuous improvement,
competencies, and customer satisfaction elements
• Enhanced training, measurement and analysis and our documentation system
©2014 MFMER | slide-13
Quality Management System - Key Components
Continuous Improvement
Customer Service &
Satisfaction
Culture
QMS Administration
Documentation System
Management Commitment
Measurement & Analysis
Competence, Awareness & Training
Start
©2014 MFMER | slide-14
Research Finance Mission Statement
• Mayo Clinic Research Finance believes in quality management. Research Finance aspires to use quality as the vehicle behind all it does in an effort to meet and exceed our customers’ expectations. The Research Finance Quality Management System emphasizes a proactive approach to meeting our customers’ needs and to ensure continuous improvement.
Management Commitment
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Establishing a Quality Culture
• Work environment
• Readiness
• Employee engagement and empowerment
• Expectations
• Accountability
• Promote teamwork
• Promote continuous improvementCulture
©2014 MFMER | slide-16
Self-Monitoring Tools
©2014 MFMER | slide-17
QMS Annual Plan
• Critical part of a Quality Management System
• Identifies long term goals and current year objectives
• Commits required resources in writing
• Provides staff with direction for coming year
Management Commitment
CultureQMS Administration
©2014 MFMER | slide-18
Annual Plan Content
Management Message:
Communicates expectations, incorporates QMS elements and conveys that the QMS plan is owned by the department
Define Scope:
Identifies area that QMS supports
Purpose of the Department’s Quality Plan
Describes actions taken to ensure core business processes and QMS are continually improved
©2014 MFMER | slide-19
Annual Plan ContentGoals:
Communicates long term purpose for plan, doesn’t need to be measureable
Objectives:
Define time frame, objectives are specific and measureable
Activities by QMS Element
Align QMS work identified within the plan with the eight elements
Quality Plan Administration
Identifies responsibilities of the plan administrator
©2014 MFMER | slide-20
• Policies, Procedures and Work Instructions
• Policy – organization’s official position setting an expectation of behavior
• Procedure – high level of roles and responsibilities explaining how it happens
• Work Instruction – documents how to perform the work
• Record Retention
Documentation System
Documentation System
©2014 MFMER | slide-21
• Stores policies, procedures and work instructions
• Automated emails or monthly reports • Identifies person/area responsible for
documents• Check in/out, version control, and historical
content available
Content Management System
©2014 MFMER | slide-22
Competence, Awareness & Training
• Employee performance appraisals
• Learning management system
• Training • Education based format (utilize Bloom’s
Taxonomy)• Competency assessment
Competence, Awareness & Training
©2014 MFMER | slide-23
Bloom’s Taxonomy
http://nashvilleisd.groupsite.com/uploads/files/x/000/04b/a15/performance_verbs_for_learning_objectives.png
©2014 MFMER | slide-24
Standard Training Format
• Title
• Objectives utilizing Bloom’s Taxonomy• Define Cost Sharing
• Introduce and discuss each objective
• Test your knowledge questions• “____________or matching means that portion of
project or program costs not borne by the Federal Government.”
• Summary restating objectives• Cost sharing is the portion of project costs not borne
by the Federal Government.
©2014 MFMER | slide-25
Bloom’s Taxonomy
©2014 MFMER | slide-26
Standard Training Format
• Title
• Objectives utilizing Bloom’s Taxonomy• Define Cost Sharing
• Introduce and discuss each objective
• Test your knowledge questions• “____________or matching means that portion of
project or program costs not borne by the Federal Government.”
• Summary restating objectives• Cost sharing is the portion of project costs not borne
by the Federal Government.
©2014 MFMER | slide-27
Competency Plan
1. Conduct needs assessment
2. Identify competencies addressed by job
3. Write goals and objectives
4. Determine teaching methods
5. Determine assessment methods
6. Determine program improvement methods
©2014 MFMER | slide-28
Measurement and Analysis
• Balanced Scorecard
• Outcomes • Financial • Processes • People
Strategic Plan
Measurement & Analysis
©2014 MFMER | slide-29
Measurement and Analysis
• Compliance - Internal Control Evaluation (C-ICE)
• Scoping• Flows & Controls• Testing• C-ICE Metrics
©2014 MFMER | slide-30
Customer Service & Satisfaction
What is customer service?
Customer service is exceeding the needs of both internal and external customers.
Tools:
• Event Management
• Voice of the Customer (VOC)
Customer Service & Satisfaction
©2014 MFMER | slide-31
Continuous Improvement
1. Establish Scope
2. Identify & Define
Reportable Categories
3. Report Results
4. Outline
EscalationQuality
Assurance
ContinuousImprovement
©2014 MFMER | slide-32
Quality Assurance Controls
90 % of all QA findings are process issues
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Continuous Improvement
1. Establish Scope
2. Identify & Define
Reportable Categories
3. Report Results
4. Outline
EscalationQuality
Assurance
©2014 MFMER | slide-34
Quality Assurance Control Chart
©2014 MFMER | slide-35
Quality Assurance Tools
©2014 MFMER | slide-36
Project Management vs. DMAIC
When to use DMAIC
Improves an existing process
Required steps for DMAIC
CharterStakeholder AnalysisCommunication planProject plan/timelineClosure
Value Stream MapEstablish and validate measurement systemData collection
When to use Project Management
Establishes a new process
Required steps for Project Management
CharterStakeholder AnalysisCommunication planProject plan/timelineClosure
©2014 MFMER | slide-37
Project Management (PMBOK)
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Linking DMAIC and Change
* Many change management tools can (and should) be used in more than one phase.
©2014 MFMER | slide-39
Control Limits and Defined Escalation Processes
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Self-Monitoring QMS
• Identify controls • Visual • Easily understood
• Defined escalation• Communicated• Administered
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• Policies, procedures and work instructions warehoused in content management system
• Expectations and due dates communicated
Documentation Controls
©2014 MFMER | slide-42
Balanced Scorecard
©2014 MFMER | slide-43
Documentation Controls
Definition: Monthly summary of Research Finance documents that have been filed by the due date
Calculation Description: Total Records Retained (paper & electronic) divided by Total Records Requiring Retention
Long Term Goal: 100 % resolution - 95% or greater is green, less than 95% is yellow and less than 90% is red
Metric Steward: John Smith
Source: Record Retention Metrics
Analysis Summary: For the month of January this metric falls within the desired range
Record RetentionPercent of Research Finance Documents filed On Time
139 140 142 141
128 129 125 130140
132 135 129139 140 141
138128 129
125130
140132 135
129
100% 100% 99% 98% 100% 100% 100% 100% 100% 100% 100% 100%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0
20
40
60
80
100
120
140
160
180
200
Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13 Jan-14
Total Electronic + Paper Total Completed on Time % Compliant
©2014 MFMER | slide-44
QMS Metrics
• Timely Federal Financial Report (FFR) submission
• Past due employee performance appraisals
• Completion of assigned compliance training
• Successfully passing the Competency Assessment
• Completion of C-ICE flows, controls and testing
• Timely filing of documents for Record Retention
©2014 MFMER | slide-45
Quality Assurance Control Chart
©2014 MFMER | slide-46
Quality Assurance Controls
90 % of all QA findings are process issues
©2014 MFMER | slide-47
Does it really work?
Continuous Improvement
Customer Service &
Satisfaction
Culture
QMS Administration
Documentation System
Management Commitment
Measurement & Analysis
Competence, Awareness & Training
©2014 MFMER | slide-48
QMS – Before and After
Vis
ion
Mission
Goals / Objectives
Vis
ion
Mission
Goals / Objectives
Before QMSQMS
Implementation After QMS
©2014 MFMER | slide-49
Indicators of Success
• Staff Costs:• FTE reduced nearly 15% over the past two
years as a result of process improvement• Process Improvements:
• 35 process improvement projects were completed in the last 9 months of 2013
• Accomplishments
©2014 MFMER | slide-50
Mayo Clinic A-133 Audit Trend(Research Specific)
©2014 MFMER | slide-51
Summary
• Implement a Quality Management System
• A QMS consists of eight key components
• Self-monitoring tools help maintain an efficient and effective QMS
• Control limits and defined escalation processes need to be understood
©2014 MFMER | slide-52
Questions/Discussion