Systematic Risk Analysis Based Approach to Quality Management Process Mapping
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1 Systematic Risk Analysis Based Approach to Quality Management Process Mapping Frank Rath University of Wisconsin and The Center for the Assessment of Radiological Sciences
2 Disclosures I am the Secretary Treasurer of the non profit Center for the Assessment of Radiological Sciences, an organization dedicated to improving the safety of radiotherapy
3 Learning Objectives Systems level QM thinking, tools and approaches The basics of process mapping Process mapping exercise Wrap up and questions
4 Quality Management in Industry Systematic application of specific tools that improve process controls producing more consistent and closer to optimal outcomes and reduce the risk of mistakes, errors or hazardous outcomes
5 Process Controls Process controls for grilling a steak Experience/training how much charcoal to pile in the middle of the grill, etc. Measurement tools watch(steak goes on the grill 20 minutes after igniting the coals) Because there are some variables that are difficult to control meat thermometer (135 deg. F)
6 Failure Mode and Effects Analysis FMEA A risk assessment tool tool used to identify weaknesses or deficiencies (inadequate controls) in processes that could lead to mistakes, errors, and potential hazardous outcomes
7 FMEA Four separate and independent types of FMEA Design FMEA Focus on the product development and design process Process FMEA Focus on the manufacturing, production, office or healthcare process Application FMEA Focus on your product as used by your customers Service FMEA Focus on the service of your products
8 Design FMEA FDA requires that equipment manufacturers demonstrate design control Quality System Requirements (QSR) Recommend D FMEA Equipment performs (functions) as defined However Equipment manufacturers almost never complete Application FMEA FDA regulatory oversight somewhat lacking in this area
9 Radiation treatments can turn deadly Powerful and complex machines offer new ways to heal and to harm 4radiation.html
10 A Proactive Strategy for Improving Patient Safety and Healthcare Quality through the use of Process Mapping, FMEA and FTA Begins with a complete and thorough understanding of the process process maps, flow charts, process trees Perform a Process FMEA (P FMEA) to identify weaknesses or inadequate controls in the process Develop process controls that either reduce the risk or improve the process Use FTA to identify root causes of potential process failures and develop recommendations to improve quality control of the process
11 Completing a Process FMEA Create a team Teams always out perform individuals Ideally cross functional, representing every function involved in the process Nurses, imaging technicians, oncologists, medical physicists, treatment planners, others (administrative staff, social workers, etc.) Effort should be led by a facilitator trained in or familiar with the tools used in the analysis Consider providing training
12 Completing an Process FMEA Select a process key step Opportunity Quality issues, past problems, not happy with the level of success, Realistic opportunity to make improvements Complexity or scope
13 Completing an Process FMEA Defining the current process One picture is worth ten thousand words Process maps, flow charts, process trees, and value stream maps
14 A flowchart is a pictorial representation of a logical decision process, which identifies all of the major steps and decision points involved in progressing from the beginning to the end. Step 1 No Decision 1 Yes End Step 2 Etc. Flowcharts provide a global overview of a procedure clearly identifying how each step is related to the others in order to accomplish a particular objective.
15 Example Monoclonal Antibody Production
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17 IMRT Process Tree
18 Treatment Planning Branch from IMRT Process Tree
19 Lean and Value Stream Mapping
20 Exercise Working in a team, create a process map for verifying patient identity and planned treatment or another process of your choice in Radio Therapy Use simple symbols boxes, ovals, circles to define each step or decision Report out
21 Questions?
7/21/2014. Failure Mode and Effects Analysis (FMEA) Disclosures. Acknowledgement. I have nothing to disclose
Mode and Effects Analysis (FMEA) M. Saiful Huq, PhD, FAAPM, FInstP Professor and Director of Medical Physics Department of Radiation Oncology University of Pittsburgh Cancer Institute and UPMC CancerCenter
Process Mapping. Acknowledgements 7/21/2014. Disclosures
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