4. Quality Management Part 2

What is the main focus of Lean principles in quality management?

To focus on efficiency and reduce waste.

Is Lean management ever considered complete?

No, Lean is never completed; it is a continuous process.

Lean management aims to deliver more value with __ waste.

Less waste.

What does Lean Six Sigma integrate?

It integrates Lean principles with Six Sigma tools.

What is Six Sigma primarily focused on?

Reducing diagnostic errors and increasing consistency in test results.

The key tool in Six Sigma is __.

DMAIC.

What does DMAIC stand for?

Define, Measure, Analyze, Improve, Control.

What does 'Define' in DMAIC entail?

Identifying the problem, such as increased hemolysis in specimens.

In DMAIC, what is the purpose of 'Measure'?

To collect data and determine defects.

What does 'Analyze' in DMAIC help to identify?

Root causes of problems.

What is the goal of the 'Improve' step in DMAIC?

To fix problems and ensure solutions prevent recurrence.

What is meant by 'Control' in the DMAIC process?

Ensuring sustained improvement through continuous monitoring.

In quality management, what cycle does PDCA represent?

Plan, Do, Check, Act.

How does PDCA differ from DMAIC?

PDCA is a repetitive model for continuous improvement, while DMAIC is data-driven for process improvement.

What are common Lean Six Sigma projects in clinical labs?

Reducing turnaround time for tests and minimizing hemolysis.

What is a critical part of risk management in organizations?

Identifying and planning for potential risks.

What can legal action be classified as in terms of risk?

A potential risk that could affect an organization.

What does the risk management process entail?

Identifying what could go wrong, reducing the chances it happens, and minimizing harm.

In the context of risk management, what does 'DEFINE' refer to?

Identifying a risk or problem, like mislabeled specimens.

What is included in the 'MEASURE' step for risk management?

Collecting data on how often risks occur.

What are the effects of 'ANALYZE' in risk management?

Determining root causes of risks.

How does one 'IMPROVE' in risk management?

By implementing solutions to reduce identified risks.

What is a key action in the 'CONTROL' stage of risk management?

Monitor solutions to ensure improvements last.

What are key components of risk assessment?

Probability, impact, detectability.

How is the risk rating calculated in risk management?

By combining probability, impact, and detectability.

If the severity score in RPN calculation is 10, what does that imply?

It could cause catastrophic harm.

An RPN score of 225 indicates what level of risk?

High risk, requiring immediate corrective actions.

Identify a critical severity risk scenario in the laboratory.

Incorrect patient results due to mislabeled specimens.

What method is used to assess potential failures in processes?

Failure Modes and Effects Analysis (FMEA).

What does the Fishbone diagram aid in during risk analysis?

Categorizing potential causes of a problem.

What is the 5 Whys technique primarily used for?

Identifying the root cause of a problem by asking 'Why?' repeatedly.

What does a flowchart tool visualize?

The step-by-step process to identify errors or delays.

An example goal in SMART criteria focuses on what aspects?

Specific, Measurable, Achievable, Relevant, Time-bound.

What constitutes a specific goal?

A clear and well-defined objective.

How can goals be made measurable?

By quantifying them so that progress can be tracked.

What determines if a goal is achievable?

The resources available and potential obstacles.

What aspect does the relevance of a goal address?

Ensuring the goal aligns with overall objectives.

Why is having a time-bound goal important?

It provides a deadline for achieving the goal.

What is an example of a specific goal in a lab?

Reduce specimen labeling errors in Hematology.

What is the aim of conducting root cause analysis?

To determine why an incident occurred.

What does RCA seek to prevent within clinical labs?

Errors that could harm patients or compromise quality.

What is an example of an outward and root cause in RCA?

Outward cause: QC fails; Root cause: Reagent temperature issues.

What is the primary aim of the Fishbone diagram in RCA?

To organize and categorize potential causes of a specific problem.

What do you analyze after creating a Fishbone diagram?

Relationships between the causes to identify root causes.

In RCA, what are the key factors used to assess potential failures?

Severity, frequency/occurrence, and detection.

What approach does the PDCA cycle involve?

A repetitive method for ongoing improvement and prevention.

What is a Swimlane diagram used for?

Visually mapping out roles and responsibilities in a process.

What's crucial to monitor after implementing changes in quality management?

To ensure that the changes are effective.