Laboratory Quailty Managment Flashcards
Why do we need quality management ?
To improve quality of a product or a process.
Quality management system components include quality statement, quality policy, quality manual and quality manager.
What is the driving force
Annual management review is the driving force along with accreditation.
During AMR staff monitors progress, sets targets and discuss long term goals
Inputs include Health and safety reports Financial reports overtime External reports Workload stats Quality reports eg complaints and audits
Outputs include
Audit activity planned
Planning for the next year and beyond
Resource implications setting achievable objectives with realistic timescale.
What are the important components of quality management?
Components include
Control of process records
Department audits
Control of clinical material
Quality indicators= a measurable variable that can be used to determine the degree of adherence to a standard. such as complaints error logs and user satisfaction surveys.
Horizontal audit= a detailed check of one particular aspect of the examination process or quality management system. Such as staff training and equipment.
Examination audit= a laboratory procedure currently being carried out in the laboratory is randomly selected for audit. Opportunity to talk to staff and understanding their awareness of task being performed. Also ensures that what is being done is reflects what is described in the procedure.
Vertical audit. Examines all elements in QMS. Tracks sample from the receipt to issue of report. Randomly selects one request form and it’s associated sample filling it through every stage. Focuses on pre examination, examination and post examination process.
How do labs check the QMS internally
Through internal audits which is a check to establish whether all activities that affect quality are being carried out correctly. Audit provides an important mechanism for the detection and investigation of a non-conformance.
Examples include audit calendar- aims to review the QMS for department within a yearly cycle.
Scheduled internal audits to be carried out and can be measured against CPA/ISO 15189 standards
Also different types of audits these include horizontal, examination and vertical audits.
How is the QMS independently checked? (Externally)
Through accreditation bodies such as CPA and UKAS and ISO 15189 CPA standards A. Organisation and QMS B. Personnel C. Premises and environment D. Equipment, information systems and materials E. Pre examination processes F. Examination processes G. Post examination phase H. Evaluation and QA
CPA have a main inspection every 4 years with a surveillance visit every two years
UKAS labs are inspected more regularly with potential for unannounced visits.
The failure to fulfil a requirements of a standard results in a non conformity.
External quality assurance asks are my results the same as other laboratory’s.
What is internal quality control?
The process carried it to check that reagents and equipment are performing within specifications.
Criteria are often defined in terms of Westguard or Multi-rules.
The rules we use are 1(3s), 2(2s) and R(4s) these are RED OR FAILURE RULES.
4(1s) , 10x and 1(2s) YELLOW OR WARNING RULES.
