GENERAL QA/QC PROCEDURES FOR TESTING LABORATORIES (PART 1)

What is Laboratory Quality? (Multiple answers)

• Conformance to customer specification

• Able to achieve precision and accuracy required

• Zero non-conformity

• Accurate, reliable and traceable of test result

WHAT IS LABORATORY QUALITY ASSURANCE (QA)? (Multiple answers)

• an ongoing, comprehensive program which analyzes every aspect of an entire operation/ processes

• determining a quality goal, deciding whether or not the goal has been achieved, and implementing corrective action if the goal has not been reached

• Insurance for laboratory

• written policies and procedures are established and followed to monitor and evaluate the ongoing and overall quality of the total testing process

WHAT IS LABORATORY QUALITY CONTROL (QC)?

• Quality control personnel

• Methodologies / measures used to determine, monitor and verify the effectiveness of the quality assurance programme

• Quality control procedures

Personnel competency verification and assessment is required prior authorized to perform specific test / task (Multiple answers):

• To ensure the accuracy achieved by the personnel

• To monitor the consistency of the personnel

• Ensure personnel attitude during test

• Personnel is able to demonstrate and conduct the test accordance to procedure

Method verification is...

• verification, where the specified requirements are adequate for an intended use

• provision of objective evidence that a given item fulfils specified requirements

• The ability of a method to determine accurately and specifically the analyte of interest in the presence of other components in a sample matrix under the stated conditions of the test

• The ability of a method to measure only what it is intended to measure. To determine any interference affect the result

Method validation is ...

• provision of objective evidence that a given item fulfils specified requirements

• The ability of a method to determine accurately and specifically the analyte of interest in the presence of other components in a sample matrix under the stated conditions of the test

• verification, where the specified requirements are adequate for an intended use

• The ability of a method to measure only what it is intended to measure. To determine any interference affect the result

When normally we use the Certified Reference Material / Standard for? (Multiple answers)

• For calibration / intermediate checks

• As Quality Control sample (reference value) during testing

• For method verification and validation

Purposes of audits? (Multiple answers)

• Check compliance with requirements

• Effectiveness of management system

• To initiate correction and corrective action

• Evaluate the needs for improvement

PDCA means?

• Please; Do; Come; Again

• Plan; Do; Check; Act

• Plan; Do; Check; Again

• Plan; Do; Compromise; Action

In PDCA Diagram, Do = Act?

• Yes. Do and Act both mean implement action

• No. Do means implementation; Act means correction and corrective action

• None of the above