This document discusses process improvement in quality management systems. It outlines Deming's Plan-Do-Check-Act model for continual process improvement. Key aspects of process improvement include identifying problems, developing improvement plans, implementing plans, reviewing effectiveness through audits, and adjusting plans based on results. Quality indicators are important tools that provide measurable information on performance to identify areas for improvement. Selecting the right quality indicators and developing them successfully is also discussed.

1. Session 11:
Process Improvement
Dr. Shree Baboolal
2/4/2023 1

2. Process Improvement – Role in QMS
• Process Improvement –
establishes a program for helping
to ensure continual improvement
in the lab over time.
• Continual improvement of the lab
processes is essential in a QMS.
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3. W. Edward Deming
• Guru of Process Improvement.
• Deming Plan-Do-Check-Act
(PDCA) shows how to achieve
continual improvement in any
process.
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4. PDCA
• Plan –
• Identify the problems and the
potential sources of system weakness
or error.
• Decide on the steps to be used to
gather information.
• Ask the question “How can you best
assess the current situation and
analyze root causes of problem areas?”
• Using the information that is gathered
through these techniques, develop a
plan for improvement.
• Do –
• Implement whatever plans
have been developed.
• Put the plan in action.
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5. PDCA
• Check –
• Refers to the monitoring process.
• It is important to assess the
effectiveness of the actions taken.
• This is done using focused review
and audit process.
• After checking, revise the plan as
required to achieve the
improvements needed.
• Act –
• Take any corrective action that is
required and then recheck to be
sure that the solution has worked.
• This cycle is a continuous process,
so the lab will begin again with a
planning process to continue the
improvements.
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6. ISO 15189 and Continual Improvements
• Activities for achieving continual improvements in the laboratory:
• Identify potential sources of any system weakness or error.
• Develop plans to implement improvement
• Implement the plan
• Review the effectiveness of the action through the process of focused review
and audit.
• Adjust the action plan and modify the system in accordance with the review
and adjust results.
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7. What is Process Improvement?
• What is process improvement?
• Systematic and periodic approach to improving lab quality.
• In the lab patient samples are turned into results through processes.
• In process improvement – these processes are reviewed and improved to
ensure quality.
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8. Tools for Process Improvement
• Internal and External Audits
• Identify system weakness and problem areas.
• Participation in EQA
• Allows for comparing laboratory performance to that of other laboratories.
• Management Review
• Reviews of records such as QC, inventory management, equipment
managements etc.
• Review of Quality Indicators
• Customer complaints, TATs, errors etc.
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9. Quality Indicators
• Established measures used to determine how well an organization
meets needs and operational performance expectations.
• ISO15189 states that the lab SHALL implement quality indicators to
systematically monitor and evaluate the lab’s contribution to patient
care.
• When OFIs are identified the lab management SHALL address them
regardless of where they occur.
• ISO 15189 also states that labs participate in quality improvement
activities that deals with patient care.
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10. Quality Indicators
• Quality Indicators are information that is measured. The indicators:
• Give information about the performance of a process
• Determine quality of service
• Highlight potential quality concerns
• Identify areas that need further study and investigation
• Track changes over time.
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11. Selecting quality indicators
• Fewer are better.
• Too many may make it difficult to track
• Link the indicators to the factors needed for success.
• Choose the quality indicators that relate to areas that need correction in
order to achieve good performance.
• Select those that will be most meaningful to the laboratory.
• Indicators should be around customers and stakeholders needs.
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12. Selecting Quality Indicators
• Measures should look at all levels of the laboratory.
• Include indicators that will evaluate function at the top management level,
but also flow down to all levels of employees.
• Measures should change as the environment and strategy changes.
• Do not stick with the same indicators over long periods of time.
• Base the targets and goals for the measures on rational values, rather
than values of convenience.
• They should be established on the basis of research rather than arbitrary
estimates.
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13. Developing Successful Quality Indicators
• When developing successful quality indicators, ensure the following:
• Objective:
• Indicators should be measurable – usually in % or numbers e.g. contamination rate >2%
• Should not depend on subjective judgements
• Concrete evidence that the event occurred or not – e.g. number of errors
• The target is clearly met – e.g. if the target for successful PT is 80% or more.
• Methodology available:
• Be sure that the organization has the tools needed to accomplish the necessary
measurements.
• The laboratory must have the ability to gather the information.
• If the data or information collection requires special equipment, then make sure the
special equipment is available before starting.
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14. Developing Successful Quality Indicators
• When developing successful quality indicators, ensure the following:
• Limits:
• The laboratory will need to know the acceptable value before starting measurements.
• Determine in advance the limits of acceptability, and at what point a result causes
concern.
• Also consider what action will be required. For example, how many delayed reports per
month would be considered acceptable? How many would be considered as requiring
corrective actions? How many would require immediate revision of the action plan?
• Interpretation:
• Decisions must be made as to how indicator information will be interpreted before
beginning measurements.
• Know in advance how to interpret the information that has been collected. For example,
if you are monitoring completed requisitions to see if they are correct, you need to know
how many samples you have examined, if they have come from multiple sources or all
sources, and whether they are for only one type of sample or all sample types.
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15. Developing Successful Quality Indicators
• When developing successful quality indicators, ensure the following:
• Limitation:
• The organization should understand exactly what information is being provided by the
indicator, and be clear on what is not being determined by the measurement of a particular
indicator.
• For example, if collecting the number of accidents or errors, do you know if all are being
reported?
• Presentation:
• The organization must decide how to present the information in order to fully display its
value.
• Some information is best presented in a table, whereas other information might be best
shown by a longitudinal graphic bar or in text.
• Presentation of information is important when looking for trends that predict future
outcome.
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16. Developing Successful Quality Indicators
• When developing successful quality indicators, ensure the following:
• Action Plan:
• Before beginning the use of an indicator, the laboratory should have some idea of what
to do if the indicator shows that there is a problem.
• Also decide how to collect the information, who will collect it, and how long it will be
collected.
• Exit Plan:
• Because making these measurements takes time and resources, there should be a plan
as to when to stop using a particular indicator and replace it with another.
• Generally, this is done when the original indicator shows that the operation is working
and stable.
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17. Characteristics of Good QIs
• Measurable – evidence can be gathered and counted.
• Achievable – the lab has the capacity to gather the evidence
• Interpretable – information can be used to make decisions
• Actionable – it is possible to do something about it
• Balanced – in all phases of testing
• Engaging – should examine work of all staff and not just selected staff
• Timed – consider short and long term implications
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18. Common Indicators tracked
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19. Implementing Process Improvements
• Essential factors and steps:
• Commitment from all levels of the lab staff.
• Careful planning so that goals can be achieved.
• An organizational structure that supports process improvements.
• Leadership.
• Engagement of the people who normally do the tests
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20. Quality Improvement Activities
• Use a timeline and do not take on more than can be accomplished
within a timeframe.
• Use a team approach involving bench level staff.
• Use appropriate quality improvement tools.
• Implement corrective and preventive actions.
• Report quality improvement findings and corrective action progress
to management and staff.
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