FMEA Six Sigma Methodology: Critical-To-Quality in the Clinical Laboratory

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Table of Contents

Executive Summary

Quality and Risk Management in Relation to Six Sigma

Quality Management

Risk Management

How Is Your Quality Management System (QMS) & Risk Management Program Infused with LEAN Six Sigma (σ) Methodologies?

References

What can Canadian Clinical Diagnostics, do for your stand-alone or regional healthcare organization?

Contact Information

Legal Notices

Executive Summary

There is a direct relationship between Quality and Cost, which is the main focus of Six Sigma. “Six Sigma is a rigorous, focused, and highly effective implementation of proven quality principles and techniques”1.Lean and/or Six Sigma methodologies are embedded within your clinical laboratory’s Quality Management System (QMS) and Standard Operating Procedures (SOPs) and you probably don’t even realize it.

ROI has been proven time and time again in automotive and production industries who have improved from three sigma to a six sigma level of quality. Yet, all healthcare leaders struggle to find the right metrics to calculate the cost savings attributable to Six Sigma methods and their positive effect in the direct, hands-on, healthcare areas. It is difficult, if not impossible, to translate and layer the entire arsenal of complex Six Sigma formulas and methodologies from the automotive industry to healthcare. We don’t have the magic formula to produce the golden egg that CFOs and CEOs can grasp as a direct causal relationship between Six Sigma implementation strategies and operational savings at the bedside in patient outcomes.

Humans are not infallible and a certain portion of deaths due to medical errors are impossible to erase within the healthcare environment. Healthcare Senior Leadership though needs to integrate Quality principles, Risk mitigation initiatives, and Lean Six Sigma methodologies into all areas of healthcare operations that affect patient care and support. Quality Management, Risk Management, and Six Sigma methods are each desired on their own; however, they can and do converge at the apex within the best of the best, highest-quality, healthcare organizations and clinical laboratories in the world.

Quality and Risk Management in Relation to Six Sigma

Quality and Risk within a Clinical Laboratory go hand in hand. There is a direct inverse relationship between Lab Quality and Risk.

A Decrease in Quality = An Increase in Risk

An Increase in Quality = A Decrease in Risk

Further, there is a direct relationship between Quality and Costs, which is the main focus of Six Sigma. “Six Sigma is a rigorous, focused, and highly effective implementation of proven quality principles and techniques”1.

An Increase in Quality, especially to a Six Sigma level, takes a huge investment in non-patient workload hours and operational expenses from the outset through implementation. It costs an exorbitant sum of money to attain a Six Sigma level of quality, particularly in Healthcare. Though, we just cannot afford a Six Sigma level of quality over the entire healthcare spectrum – we demand the Six Sigma quality in the cars we drive, but not in our healthcare services. That is why tragic deaths due to medical errors will continue at a staggering rate.

However, there is a significant Return OnInvestment (ROI) that can be sustained once the initial investment in Six Sigma has been paid.1

Contradiction: Increased Healthcare Costs ≠ Increased Quality, Necessarily

Increased Healthcare costs does not always equal or drive an Increase in Quality. An example of this is in the U.S. where “expensive new therapies are adopted without good evidence that they improve patient outcomes. A recent example comes from the approval of new cancer drugs, which can cost well over $100,000 per year and are often expected to extend life for little more than a month”2. So, we continue to invest money in the wrong areas, which produce little or no tangible savings.

Quality Management

is the “coordinated activities to direct and control an organization with regard to quality, which includes establishment of the Quality Policy/Objectives, Quality Planning, Quality Control, Quality Assurance, and Quality Improvement”3.

Pyzkek and Keller, authors of The Six Sigma Handbook, state “it would be a mistake to think that Six Sigma is about quality in the traditional sense. Quality, defined traditionally as conformance to internal requirements”1. Further, to link Six Sigma’s main focus to help organizations make more money by improving customer value and efficiency. Therefore, to link this aspect of Six Sigma to Quality, a new definition of quality is required: the value added by a productive endeavor. Then, Quality vis-à-vis Six Sigma can be expressed as potential quality (maximum possible value per unit of input) and the actual quality (current value per unit of input).The difference between possible and actual quality is waste – therefore, decreasing waste increases quality and vice-versa.1

Risk Management

is the “systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk”3.

Is Real Change Possible in Healthcare: “Risky Behaviour” = A “Transformed Organization”?

People who refuse to take risks in life and always play it safe will never push the boundaries of their potential. If you don’t apply for a new higher level position at your workplace because you don’t have the confidence in yourself and you don’t accept the associated risk of possible failure, then you will probably be passed over for other promotional opportunities. Moreover, Pyzdek and Keller recommend that “customer-driven organizations encourage risk-taking in a variety of ways” and “celebrate mistakes made by individuals who engage in risky behaviour”as an element of the “Transformed Organization”1.

However, that is the difference between meeting customer demands in the business world and meeting patient needs in the healthcare world. In healthcare we do not ever want to risk patient lives. We cannot ever deviate from our Medical Director – approved standard operating procedures (SOPs) in the clinical laboratory or we do so at our own peril and potential loss of license to practice. If a clinical laboratory team member thinks that an approved procedure is incorrect or needs to be changed in anyway, that person shall put a Change in Document Request for the Quality Manager and others to investigate. The document is revised and approved by the Medical Director; the old version is archived by ISO15189 standards

Standardization and consistency are the strengths of a Quality Management System and the International Organization for Standardization (ISO) 15189 or other accreditation requirements. Certainly, SOPs slightly may differ from one healthcare organization’s clinical laboratory to another but the #1rule of Quality Management is Say what you do and always do what you say you do.

Pyzdek and Keller mention that these organizational formal rules (ie. SOPs) are a barrier to change as they standardize behaviour. They assert that because of these rules, an organization “can find itself moribund in a fast-changing external environment. This is a recipe for disaster”1. I understand what they are saying, because they support these comments by saying that projects in any industry, including healthcare require out-of-the-box thinking and “union work rules” prevent this from happening. I have experienced this many times myself in management – there is a blue-sky vision in an operational area that we would love to do; however, it is often relegated to a less creative, inspirational vision to what we can do.

What Came First – The Chicken or The Egg?

Did Quality Management or Risk Management come first?Well, managementis the key word. All quality aspects of clinical laboratory services must be handled, controlled, and packaged tightly into a well-designed and fully documented Quality Management System based on ISO15189/ISO15190/ISO22870 accreditation requirements. Laboratory services do not have complete quality without completely recognizing, mitigating, and controlling all risks in its operations.

So, we are back again to that same question: What came first – The Chicken or The Egg? Way back when in the history of our Clinical Laboratory profession did our laboratoryprofessional forefathers and foremothers worry first about Quality, then they figured that Quality work would squeeze out risk as a by-product; did they worry first about Risks associated with Lab policies, processes, procedures; or, did they worry about Risks at all? They certainly did not worry about risk of litigation back in the early days of laboratory medicine – they were pioneers just trying to diagnostically support their physicians/patients. Of course, traditional clinical laboratories alsodid not have any knowledge of Six Sigma methodologies as they pertain to “customer requirements, defect prevention, cycle time (takt) reduction, and cost savings”1.

How Is Your Quality Management System (QMS)& Risk Management Program Infused with LEAN Six Sigma (σ) Methodologies?

These are just some of the Lean and/or Six Sigma methodologies that are embedded within your QMS and Standard Operating Procedures (SOPs) and you probably don’t even realize it. The Outcomes and Achievements are just some of the positive effects upon the clinical laboratory when the corresponding Lean Six Sigma applications are fully applied. The chart is meant to be a brief overview to provoke some thought, not an exhaustive brainstorming compilation.

QMS Quality System Essentials (QSE) / LEAN Sixσ Applications / Outcomes and Achievements
Organization
Personnel / Value Stream Mapping;
Continuous Quality Improvement / Staffing model mapped and examined to utilize Pathologists, Lab Technologists, Lab Assistants, Medical Transcriptionists, et cetera optimally. Quality Improvements: employee recruitment and retention; Improved Staff Schedules to sustain/improve quality of work life; Sustain/Improve Competency framework of all Laboratory personnel for smoothness of operations; Professional staff focus on abnormal/fault conditions; Operational savings and/or efficiencies; Personnel Efficiency enhanced; Team Involvement & Empowerment;
Equipment / Value Stream Mapping; 5S Workplace Organization; Poka-Yoke; FMEA; Standard Work: Total Productive Maintenance / Reduced Turn Around Times and decreased instrument downtime metrics;Automate processes as much as possible, including Auto-Verification on major analyzers; Eliminate/Mitigate Errors/Risks; All supplies for Analyzers are organized and storage is clearly labeled; All equipment/parts are regularly maintained and Ready To Use when needed. Professional staff focus on abnormal/fault conditions; Savings or More Efficient use of Personnel work hours vis-à-vis increased automation; Prevent delays in reporting results for more efficient Patient Care;
Purchasing & Inventory / Supply Chain Management; Just-In-Time Inventory; Point of Use Storage; Kanban / Standardize technology & methodology within WWLHIN; Reduced Inventory levels; Improved Supplier relationships; Build in contingencies for back-orders; Laboratory Personnel lead Stewardship and Selection of Inventory; Ensures Supplies are available in the right amount near the workstation; Economies of Scale realized; Savings in Operational Expenses; Team Involvement & Empowerment; Steady elimination of Inventory and Waiting waste; Personnel Efficiency enhanced;
Process Control / Process Mapping; Value Stream Mapping; Standardized Work: Poka-Yoke; FMEA/FRACAS / Reduced Turn Around Time; Processes are Improved; Identify & Eliminate/Mitigate Errors/Risks; Enhanced Smoothness (Flow) of operations; Prevent delays in results reporting; More efficient Patient Care; Improve patient and personnel safety; Savings in Operational Expenses; Team Involvement & Empowerment;
Documents & Records
Occurrence Management (FRACAS) / Occurrence/Defect Reporting (FRACAS); Brainstorming; Root Cause Analysis; Kata; Gemba; Poka-Yoke; Cause & Effect; Flowchart; Pareto Analysis;
All LEAN Six Sigma applications may apply / Eliminate/Mitigate Errors/Risks; Continually improve processes; Reduce Turn Around Times; Focus on work design & eliminate fluctuation of work volumes; Smoothness (Flow) of operations; Continuous quality improvement is realized;
Assessment / Root Cause Analysis; FMEA; Kata; Poka-Yoke; Change Management; Value Stream Mapping; / Eliminate/Mitigate Errors/Risks; Continually improve processes; Optimal Quality and Efficiency for all Laboratory Analytical operations;
Process Improvement / Value Stream Mapping; Kaizen; Teamwork; Standard Work: Change Management; Muda; Poka-Yoke; Brainstorming; Root Cause Analysis; Cause & Effect; Flowchart; Pareto Analysis; / Eliminate/Mitigate Errors/Risks; Continually improve processes; Reduce Turn Around Times; Focus on work design & eliminate fluctuation of work volumes; Smoothness (Flow) of operations; More efficient use of professional staff; Operational savings; Continual improvement; Reduce Non-Value adding work (reviewing normal results); Better Utilize human talent; Personnel Efficiency enhanced;
Service & Satisfaction / Value Stream Mapping; Kaizen; Key Performance Indicators (KPI) development; Teamwork; Change Management; Brainstorming; Root Cause Analysis; Cause & Effect; Flowchart; Pareto Analysis; Weighted Pareto Analysis / Reduced variations in Outcomes; Improved patient discharge procedures; Stakeholders observe improved operational support from Laboratory; Prevent delays in results reporting; More efficient Patient Care; Personnel Safety and Efficiency enhanced; Improvement of KPIs.
Facilities & Safety / Value Stream Mapping; Kaizen; Teamwork; Standardized Work: Change Management; Muda; Poka-Yoke; Brainstorming; Root Cause Analysis; Cause & Effect; Flowchart; Pareto Analysis; / Full Compliance with Occupational Health & Safety Acts; Lower rates of injuries to personnel, which has many efficiency and fiscal operational benefits; Operational and Insurance cost savings;
Information Management

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Conclusions

Quality, Risk and Six Sigma methods are all embedded in the framework of clinical laboratories to varying degrees throughout the world – and most don’t even know it. Six Sigma is pervasive in all aspects of project management, quality management, risk management et cetera, but the name Six Sigma is a foreign concept to most people even today in healthcare. Many statistically-proficient Medical Laboratory Scientists see Six Sigma strictly as a statistical phenomenon – but that part of it doesn’t even touch the entire scope of Six Sigma.

It costs an exorbitant sum of money to attain a Six Sigma level of quality, particularly in Healthcare. We just simply cannot afford a Six Sigma level of quality over the entire healthcare spectrum – we demand the Six Sigma quality in the cars we drive, but not in our healthcare services. Clinical Laboratories are mandated by law in parts of the world (eg. Province of Ontario, Canada) to be ISO15189/ISO15190/ISO22870 accredited, though it is okay for clinical/nursing areas not to have any semblance of a Quality Management System. Instead, a complex array of clinical policies and procedures without any formal structure (ie. QMS) will suffice. That is part of the reason why tragic deaths due to medical errors will continue at a staggering rate.

References

Pyzdek, T., Keller, P. (2010). The Six Sigma Handbook: A Complete Guide to Green Belts, Black Belts and Managers at All Levels, 3rd Edition. McGraw Hill, New York.
American Medical Association, (February 2014). The Complex Relationship between Cost and Quality in US Health Care. Available at: February 2014
Clinical and Laboratory Standards Institute, 2009.Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline – Second Edition. CLSI document EP18-A2. Wayne, PA.

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