Quality System Essentials

Question 1

What are the “Quality System Essentials”?

Answer 1

A set of 12 coordinated activities that serve as the building blocks for quality management in a laboratory.

Question 2

What is the focus of the “Organization” essential?

Answer 2

It covers the organized structure and management of the lab. A strong organizational structure and management commitment are critical, including having a mechanism for implementation and monitoring.

Question 3

According to the “Organization” essential, what is critical for a lab to have?

Answer 3

A strong supporting organizational structure and management commitment.

Question 4

What are the key aspects of the “Personnel” essential?

Answer 4

Ensuring staff are high quality, competent, and motivated. This involves documenting job descriptions, providing in-service training, and assessing staff morale and development.

Question 5

What does the “Personnel” essential require regarding staff documentation?

Answer 5

Documentation of job descriptions.

Question 6

What are the three main points of the “Equipment” essential?

Answer 6

1. Selecting and installing the right equipment and ensuring it works properly (see Method Evaluation). 2. Having a system for maintenance. 3. Ensuring the equipment is functioning properly.

Question 7

What are the main challenges and benefits of managing “Purchasing and Inventory”?

Answer 7

It is challenging to manage, but proper management can produce cost savings and ensure supplies/reagents are available when needed. It’s also crucial to ensure good quality and proper storage that preserves integrity and reliability.

Question 8

What is the goal of proper “Purchasing and Inventory” management?

Answer 8

To produce cost savings and ensure supplies/reagents are available when needed.

Question 9

What two main areas are covered under “Process Control”?

Answer 9

1. Quality control (QC) for testing. 2. Appropriate management of the sample, including collection, handling, and method verification/validation.

Question 10

“Process Control” includes the appropriate management of what?

Answer 10

The sample, including its collection, handling, and method verification/validation.

Question 11

What are the key concerns of “Information Management”?

Answer 11

Test reporting and managing information/data to ensure accuracy, confidentiality, and accessibility to lab staff and health care providers.

Question 12

Under “Information Management,” who should have access to the data?

Answer 12

Lab staff and health care providers.

Question 13

How are “Documents and Records” related to “Information Management,” and why are they needed?

Answer 13

They are closely related to information management. Documents are needed in the lab to inform staff how to do things, and they must be maintained meticulously to be accurate and accessible.

Question 14

Why must documents and records in a lab be maintained meticulously?

Answer 14

To ensure they are accurate and accessible.

Question 15

What is the three-step goal of “Occurrence Management”?

Answer 15

1. Detect problems or occurrences. 2. Handle them properly and learn from them. 3. Take action to prevent them from happening again.

Question 16

What is “Process Improvement” in a laboratory context?

Answer 16

The improvement of lab processes done in a systematic manner.

Question 17

What is the purpose of an “Assessment” in the lab?

Answer 17

It is a tool for examining lab performance and comparing it to standards, benchmarks, or the performance of other labs.

Question 18

What are the two types of “Assessment” mentioned?

Answer 18

Internal (within the lab using own staff) and external.

Question 19

What four main areas are covered under “Facilities and Safety”?

Answer 19

1. Security, 2. Containment (to minimize risk to the community), 3. Safety (policies and procedures to prevent harm), and 4. Ergonomics.

Question 20

Under “Facilities and Safety,” what is the goal of “Containment”?

Answer 20

To minimize risk and prevent hazards from leaving the lab space and causing harm to the community.

Question 21

Why is “Customer Service” essential for a lab?

Answer 21

It is essential that the lab’s clients (customers) receive what they need. The lab must understand who its customers are, assess their needs, and use feedback for making improvements.