Effective date: 01/02/2022 KAGANDO HOSPITAL

LABORATORY

Version no: 5.0 NC TREND ANALYSIS REPORT Doc No: KHL/AD/013/F003

SUMMARY OF TREND ANALYSIS OF NON-CONFORMANCES IDENTIFIED AT KAGANDO

HOSPITAL LABORATORY FOR THE MONTHS JULY 2023– SEPT, 2023

Review of technical records was done for the period Mentioned above focusing on the non conformities
identified and recorded at Kagando Hospital .
The objectives were;
1. To identify the type/category of non-conformities occurring in the lab at KHL
2. To identify the ISO15189;2012 clauses most violated
3. To identify a way of minimizing occurrence of Non conformities.

1. CATEGORY OF NON CONFORMITIES

Table 1; showing category of non conformities occurring in the laboratory

CATEGORY no
MAJOR 06
MINOR 0
Total 06

Fig. 1; Graph showing category of NCs

NC CATEGORIES FOR QUARTER 2 2023

5
4.5
4
3.5
3
6
2.5
2
1.5
1
0.5
0
0
major nminor

The non conformities are categorized as either Major (Having a direct impact on patients results) or
Minor (Having no direct impact on patients results).

Major 6, minor 0

2. To identify the ISO15189;2012 and ISO1590 clauses most violated

Fig 1; ISO15189;2012 clauses most violated (n= 29)

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Effective date: 01/02/2022 KAGANDO HOSPITAL
LABORATORY

Version no: 5.0 NC TREND ANALYSIS REPORT Doc No: KHL/AD/013/F003

Jul to Sept NCs

2.5

2
Number of NCs

1.5

1 2 2

0.5 1 1

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.1 4.12 4.13 4.14 4.15 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10

Total

Clause 4.1 & 5.4 violated 2 times followed by Clause 4.9 and 5.5 which were violated 2 times as
shown above.

Note; Total number of NCs identified were 6 , However some clauses were violated in combination.

Figure 2; Number of non-conformances per month

Months No of NC’s identified

July 2023 0
August-2023 6
Sept 2023 0

Observations and Trends analysis;

1. There were more non-conformities NCs for the period Qrtr 3 2023
OUTCOME OF THE TREND ANALYSIS OF THE NCs
i.All NC’s identified were major in grading,
ii.
Non conformities were equally identified from the management requirements and
technical requirements,
iii. In general most NC’s were identified during the external assessment by SANAS as
the laboratory has not routinely identified many non conformities in the quarter
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Effective date: 01/02/2022 KAGANDO HOSPITAL
LABORATORY

Version no: 5.0 NC TREND ANALYSIS REPORT Doc No: KHL/AD/013/F003

Recommendations/way forward.

A refresher training on the SOP for identification and control on non conformities should
be conducted to build capacity among all the lab staffs to identify the NC’s a head of time
so as to minimize the occurrence External assessment NC’s.

Prepared by Date

Reviewed by Date

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