Assessment

Question 1

This is the systematic examination of a performance or of the quality management system and the comparison to the standard.

Answer 1

Assessment-Audit

Question 2

This is used as the reference for what is right and wrong.

Answer 2

Standard

Question 3

This is also called “Proficiency Testing.”

Answer 3

External Quality Assessment

Question 4

This is another term for “Assessment.”

Answer 4

Audits

Question 5

This is an example of a professional that assumes the role of a laboratory director.

Answer 5

Pathologist

Question 6

These are the errors and unfollowed policies and procedures within the path of workflow.

Answer 6

Gaps

Question 7

True or False: Audit checks must be done in every step within the Path of Workflow.

Answer 7

True

Question 8

True or False: Errors are not necessary whenever audit checks are done.

Answer 8

False

Question 9

This is how often audit checks are done.

Answer 9

Must be done regularly.

Question 10

These are two examples of errors that an audit may be able to detect.

Answer 10

1. Abnormal Results
2. High Turn-Around-Time

Question 11

True or False: The quality manager is responsible for scheduling audits and reporting to staff.

Answer 11

True

Question 12

True or False: Checklists are based on the SOP.

Answer 12

False

Question 13

True or False: It is stated in the ISO 15189 that the 12 essentials must be audited once a year.

Answer 13

True

Question 14

These are audits that are simple, uncostly, and specific.

Answer 14

Internal Audits

Question 15

True or False: An auditor must be dependent from their assigned laboratory area.

Answer 15

False

Question 16

This is the meaning of OFI.

Answer 16

Opportunities for Improvement

Question 17

True or False: The laboratory director is in-charge of assigning the quality manager.

Answer 17

True

Question 18

True or False: The laboratory director is in charge of executing and scheduling audits.

Answer 18

False

Question 19

This is the reason why we perform assessment-audits.

Answer 19

To learn “where we are.”

Question 20

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.

Answer 20

Auditing

Question 21

These are examples of External Auditors.

Answer 21

Health Authorities
Accreditation Bodies
Funding Programs
Public Health Programs

Question 22

These are the preparations for an External Audit.

Answer 22

Plan
Organize
Schedule w/ Staff
Gather Information and Records

Question 23

True or False: The auditor’s closing summary doesn’t need to record actions in their report, only the results.

Answer 23

False, actions must be written as well.

Question 24

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.

Answer 24

Internal Audit

Question 25

These are the main values of Internal Audits.

Answer 25

Preparation for external audits, increased awareness, improvements, prevention, and meeting quality standard.

Question 26

As per the ISO requirement, this is what Internal Audits must have.

Answer 26

Must have an audit program, document procedures, independent, reports for review, and prompt follow-ups.

Question 27

True or False: You can audit your work.

Answer 27

False, other personnel must audit your work to avoid bias.

Question 28

This laboratory personnel determines the internal auditing policy, assigns responsibility, interprets internal audit outcomes and supports corrective actions.

Answer 28

Laboratory Director

Question 29

This laboratory personnel establishes and maintains the internal audit system, develop schedules, and trains auditors.

Answer 29

Quality Manager

Question 30

These are the necessary things to consider when establishing an audit schedule.

Answer 30

You must conduct it regularly, focus more audits in lacking areas, and must look at all 12 quality system essentials.

Question 31

This serves as a checklist and develop forms for documenting corrective actions and reports.

Answer 31

Documents

Question 32

This is a document used to address and rectify non-conformances, issues, or problems identified in various processes, products, or services.

Answer 32

Corrective Action Form (OFI Form)

Question 33

These are the important skills an auditor should have.

Answer 33

Attention to detail, trained, diplomatic, technical, good communicator.

Question 34

These are actions that serves as the steps take to improve a process or to correct a problem.

Answer 34

Corrective and Remedial Actions

Question 35

This is the key element to success in the Quality System.

Answer 35

Continuous Monitoring