Assessment Flashcards
This is the systematic examination of a performance or of the quality management system and the comparison to the standard.
Assessment-Audit
This is used as the reference for what is right and wrong.
Standard
This is also called “Proficiency Testing.”
External Quality Assessment
This is another term for “Assessment.”
Audits
This is an example of a professional that assumes the role of a laboratory director.
Pathologist
These are the errors and unfollowed policies and procedures within the path of workflow.
Gaps
True or False: Audit checks must be done in every step within the Path of Workflow.
True
True or False: Errors are not necessary whenever audit checks are done.
False
This is how often audit checks are done.
Must be done regularly.
These are two examples of errors that an audit may be able to detect.
- Abnormal Results
- High Turn-Around-Time
True or False: The quality manager is responsible for scheduling audits and reporting to staff.
True
True or False: Checklists are based on the SOP.
False
True or False: It is stated in the ISO 15189 that the 12 essentials must be audited once a year.
True
These are audits that are simple, uncostly, and specific.
Internal Audits
True or False: An auditor must be dependent from their assigned laboratory area.
False
This is the meaning of OFI.
Opportunities for Improvement
True or False: The laboratory director is in-charge of assigning the quality manager.
True
True or False: The laboratory director is in charge of executing and scheduling audits.
False
This is the reason why we perform assessment-audits.
To learn “where we are.”
This is described as gathering information, comparing the findings with documented quality management system, identify and breakdown in systems or procedures, and do something with its results.
Auditing
These are examples of External Auditors.
Health Authorities
Accreditation Bodies
Funding Programs
Public Health Programs
These are the preparations for an External Audit.
Plan
Organize
Schedule w/ Staff
Gather Information and Records
True or False: The auditor’s closing summary doesn’t need to record actions in their report, only the results.
False, actions must be written as well.
This kind of audit demands you to look at your own process, required by ISO, conducted on a regular basis, and conducted when problems are identified.
Internal Audit
These are the main values of Internal Audits.
Preparation for external audits, increased awareness, improvements, prevention, and meeting quality standard.
As per the ISO requirement, this is what Internal Audits must have.
Must have an audit program, document procedures, independent, reports for review, and prompt follow-ups.
True or False: You can audit your work.
False, other personnel must audit your work to avoid bias.
This laboratory personnel determines the internal auditing policy, assigns responsibility, interprets internal audit outcomes and supports corrective actions.
Laboratory Director
This laboratory personnel establishes and maintains the internal audit system, develop schedules, and trains auditors.
Quality Manager
These are the necessary things to consider when establishing an audit schedule.
You must conduct it regularly, focus more audits in lacking areas, and must look at all 12 quality system essentials.
This serves as a checklist and develop forms for documenting corrective actions and reports.
Documents
This is a document used to address and rectify non-conformances, issues, or problems identified in various processes, products, or services.
Corrective Action Form (OFI Form)
These are the important skills an auditor should have.
Attention to detail, trained, diplomatic, technical, good communicator.
These are actions that serves as the steps take to improve a process or to correct a problem.
Corrective and Remedial Actions
This is the key element to success in the Quality System.
Continuous Monitoring
