Quality Management ( Chapter 23 ) Flashcards
The degree to which a product or service meets requirements
Quality
The building blocks of Quality
Quality control , Quality Assurance , Quality Management System
Blood bank compliance with federal regulations and accreditation standards is required by the ff. organizations
FDA
Joint Commission
CAP
AABB
Evaluate how effectively the facility meets the requirements by detecting errors , deficiencies , and deviations .
Compliance programs
Measure the state of the facility’s program with respect to the applicable requirements at a single point in time
Compliance inspections
Compliance inspection is also known as
Surveys or Assesment
When do usually Compliance Inspection conducted
every 1 to 2 years
Planned actions that ensure that systems and elements that influenced the quality of the product or service are working as expected , individually and collectively.
Quality Assurance
Is actively and continuously practiced by the blood bank leaders , managers and staff throughout all blood bank operation.
Quality Management
Mandates an environmental control program that addresses all significant environmental issues for facility management and maintenance such as temp control , electrical safety, fire protection, and so forth
Joint Commission
Can be defined as a set of interrelated resources and activities that transform inputs into outputs
Process
Is a set of activities that ensures a given work process will keep operating in a state that is continuously able to meet process goals without compromising the process itself
Process control
Is the evaluation of the performance of a process, comparison of actual performance to a goal and action taken on any significant difference
Total Process Control
Requires that facilities design their processes and procedure to ensure that blood components are manufactured consistently to meet the quality standards appropriate for their intended use
cGMP ( current GOOD MANUFACTURING PRODUCT )
Graphically represents the sequence of activities in a process and show how the inputs are converted into outputs.
Flow Chart
Involves one or more persons who perform a sequence of activities over a period of time.
Work Process
Provide instruction for each activity in the larger process.
Standard Operating Procedures
Illustrate the sequence activities in Total Process Control
Process is Flow Charted —>
Procedures are Identified —>
Procedures are drafted —> Process are validated –>
Procedure are finalized –> Training is performed –>
Initial competence is assested –> Process performance is monitored
Test all activities in a new process to ensure that the process will work in the living environment
Validation
An example of a process control wherein one laboratory methods and procedures are compared with those of other laboratories for the ability to get the same result on a set of unknown specimens
Proficiency Testing
Are approved info contained in a written or electronic format.
Documents
Defines the QMS for external inspector and internal staff
Documents
Links a facility’s policies , process and procedures and ensure that only the latest approved copies of documents are available for use.
Document Control System
Are specially design documents either paper or electronic on which are recorded the results or outcomes of performing a given procedure
Forms
Activities include using and manipulating the donor or patient information and test results in facility’s paper and electronic information system
Information Management
Give the 6 Types of Nonconformance
Accident Adverse rxn Complaint Discrepancy Error Postdonation
A type of Nonconformance . Complications that occured to the donor during or after the donation process or to the recipient of transfused blood component
Adverse Rxn
A type of Nonconformance . Expression of dissatifaction from internal customers ( Physician , employess) or external customers ( donor , px )
Complaint
A type of Nonconformance . Difference or inconsistency in the outcomes of a process, procedures or test results
Discrepancy
A type of Nonconformance attributable to a human or system problem , such as a problem from failure to follow established procedure or a part of a process that did not work as expected
Error
A type of Nonconformance generally not attributable to a persons mistake such as a power outage or an aged instruments malfunction
Accident
A type of Nonconformance the receipt of information ( call or information letter) from donor with additional details regarding his or her donation such as subsequent illness or neglecting to mention illness or medication
Postdonation
The immediate action which is the initial quick fix soln.
Remedial Action
A very effective assessment tool that review a specific facility process and determine by examining documents and records , interview and observations whether the facility is meeting the applicable requirements
Internal Audit
What are the two types of External Assesment
Proficiency testing and External Inspection
Performed by regulatory and accreditation organization for the purposes of obtaining and maintaining the facility license or accreditation
External Inspection
The cost of implementing processes and controls to prevent the occurrence of nonconformances
Prevention cost
Give the 4 different Types of Quality cost
Prevention Cost
Appraisal Cost
Internal Failure Cost
External Failure Cost
The cost of implementing process and controls to appraise or evaluate blood bank, tranfusion service or medical laboratory’s performance
Appraisal Cost
Bad Quality Cost that expensive and hard to measure because they include both actual and intangible cost incurred to correct a nonconformance.
External Failure Cost
Is a name for processes that detect , report , evaluate and correct events in blood bank operations that do not meet the facility’s or othere requirements
Nonconformance management
Is a group of people who represents different activities in a given process and who have been brought together to identify and implement ways to solve process problems
Process improvement team
Challenges all activities in a new process before implementation to provide a high degree of assurance that the process will work as intended
Process validation
