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MAKMAL KESIHATAN AWAM KOTA BHARU

Document Number : MKAKB/BP/QP-12
QUALITY PROCEDURE
Issue Number : 01
Issue Date : 03.04.2016
MANAGEMENT OF PERSONNEL Page Number : 4 of 10

NO PROCEDURE RESPONSIBILITY

6.3.4 Conduct assessment as planned. LD/ HOU/ OIC

Verification of staff competency should be based on
either internal or external testing.

a) Internal testing for staff competency can be done
using :

• Direct observation of routine work processes
and procedures including all applicable safety
practices.
• Direct observation of equipment maintenance
and function checks. Handling of equipment
should be evaluated based on capability to
operate the specific equipment. The evaluation
should be done by supervisory or authorized
personnel.
• Monitoring the recording and reporting of
examination results.
• Review of work records.
• Assessment of problem-solving skills
• Examination of specially provided samples
such as previously examined samples, inter
laboratory comparison, split samples, internal
quality control samples and blind sample spike
with a positive or negative control.

Supervisory or authorized personnel are responsible to
arrange the test and evaluate the test result of internal
testing.

b) External testing of staff competency is done by
participating in the proficiency testing programs
provided by external agencies.

• The test result must be satisfactory and in the
acceptable range according to the each
laboratory testing.
• Supervisory or authorized personnel are
responsible to assign who should perform the
proficiency testing.

Disease Sector Quality Procedure
CONTROLLED DOCUMENT