Kulumsa Research Center Labs status report by ptb_afriqual plc

AFRICA QUALITY CONSULTING FIRM PLC
GAP ANALYSIS REPORT
Doc no. AQC/F/0 Rev. 0/16 Page 1 of 81
INTERIM REPORT
ON
GAP ANALYSIS AND ACTION PLAN FOR EIAR OF KULUMSA AGRICULTURAL
CENTER RESEARCH LABORATORIES
REPORTED
BY
REPORTED TO
PHYSIKALISCH-TECHNISCHE BUNDESANSTALT (PTB)
"Enhancement of Quality Infrastructure Services for Innovation in the Agriculture and Food
Sector"
Ethiopia and Ghana
Project No.: FV-95305 / 2015.0139.4
MAY 31, 2016, ASSELA, ETHIOPIA

GAP ANALYSIS REPORT
Disclaimer
This project work is done in accordance with PTB-Afriqual PLC contract agreement No: Project
No.: FV-95305 / 2015.0139.4. The content of this report is solely the responsibility of the authors,
and do not necessarily represent the official views of PTB.

GAP ANALYSIS REPORT
List of acronyms and abbreviations
EIAR Ethiopian institute of agricultural research
ISTA International Seed Testing Association
GLP Good laboratory practice
ISO International organization for standardization
KRC Kulumsa research center
UoM Uncertainty of measurement
FAO Food and Agricultural Organization
PCR Polymerase chain reaction
ELISA Enzyme linked immune sorbent assay

GAP ANALYSIS REPORT
List of Table
Table 1: Education and experience ...............................................................................................................18
Table 2: List of major Equipment .....................................................................................................19
Table 3: Education and experience ...............................................................................................................21
Table 4: Lists of major equipment ....................................................................................................23

GAP ANALYSIS REPORT

GAP ANALYSIS REPORT
Lists of Annex
Annex: 1 Action plan for seed quality research laboratory..............................................................................61
Annex: 2: Action plan for pathology research laboratory................................................................................67
Annex: 3: Action plan for Nutrition Research laboratory................................................................................72
Annex: 4 Soil, plant and water analysis laboratory..........................................................................................76

GAP ANALYSIS REPORT
Acknowledgement
We are indebted to the management of Kulumsa Agricultural Center
Research Laboratory management and technical staff for the warm
welcome, openness to the queries we raised, company and guidance
during the facility visit, prompt reply to email communications and
availing documents.

GAP ANALYSIS REPORT
Executive Summary
The gap analysis was performed with the objective of identifying system
deficiencies (gaps) and propose improvement plan, if any, in assuring
the competence of laboratories of Kulumsa agricultural research center.
The methodologies followed were identification of related requirements,
evaluation of records, onsite observation, and interviewing.
The gap analysis focused on technical competences such as personnel,
accommodation and environmental conditions, methods and methods
validation, equipment and traceability, sampling and sample
management, and quality assurance. Based on the findings,
recommendations were proposed.

GAP ANALYSIS REPORT
Table of contents
List of acronyms and abbreviations....................................................................................................................................3
List of Table .......................................................................................................................................................................4
Lists of Annexes.................................................................................................................................................................6
Acknowledgement..............................................................................................................................................................7
Executive Summary................................................................................................................................................8
1. BACKGROUND .....................................................................................................................................................10
2. OBJECTIVE............................................................................................................... Error! Bookmark not defined.
3. METHODOLOGY ..................................................................................................... Error! Bookmark not defined.
4. FINDINGS AND BEST PRACTICES....................................................................... Error! Bookmark not defined.
4.1 Best practice .....................................................................................................................................................12
4.2 Assessment findings ......................................................................................................................................17
4.2.1. Seed Quality Research Laboratory ................................................................................18
4.2.2. Pathology Research Laboratory.......................................................................................21
4.2.3. Nutrition Research Laboratory.........................................................................................25
4.2.4. Soil, Plant and Water Analysis Laboratory ...............................................................32
4.3. Strengths....................................................................................................................................................38
4.3.4. Soil, Plant, and Water Analysis Laboratory..............................................................44
4.4. Opportunity for improvement ........................................................................................................45
4.4.4. Soil, Plant and Water Analysis Laboratory ...............................................................54
5. SWOT ANALYSIS .................................................................................................................................................56
6. PROPOSED ACTIONS PLAN ...............................................................................................................................58
7. CONCLUSIONS AND RECOMMENDATIONS...................................................................................................58

GAP ANALYSIS REPORT
1. BACKGROUND
The Ethiopian Agricultural Research System (EARS) consist of
Ethiopian Institute of Agricultural Research (EIAR), Regional
Agricultural Research Institutes (RARIs), and Higher Learning
Institutions (HLIs). EIAR is responsible for the running of federal
research centers, and RARIs are administered by the regional state
governments. In addition to conducting research at its federal centers,
EIAR is in charge of the responsibility for providing the overall
coordination of agricultural research countrywide, and advising the
Federal Government on agricultural research policy formulation.
Currently, the EARS comprise 55 research centers and sites located
across various agro-ecological zones. The research centers vary in their
experience, human, facility, and other resources capacities.
Innovation and research in the agricultural sector require significant
capabilities for carrying out laboratory analysis. In places where
laboratories already exist, it is necessary to ensure and to extend the
technical competence and performance. In this way, results –such as
soil, water and seed quality analyses – are furnished directly for taking
decisions on what to grow and on the quality of their produces. In
addition, testing services are of importance – as they constitute a basis
for product certifications and – thus –for market access.
Considering these issues, PTB under the program “Enhancement of
Quality Infrastructure Services for Innovation in the Agriculture and
Food Sector” identified and selected laboratories of Kulumsa
Agricultural Research Center to improve their technical capabilities and
competence.
Kulumsa agricultural research center is one of the sixteen federal
research centers under Ethiopian Institute of Agricultural Research.
Currently the center has four research processes which are crops
Case Team; Livestock, Apiculture and Sericulture Research Case Team,
Soil and Water Case Team and Forestry Case Team. The center is the
national center of excellence for Wheat breeding research. The nutrition
laboratory, pathology laboratory, seed quality laboratory, and the soil,
water and plant analysis laboratory are the centers of interest.

GAP ANALYSIS REPORT
2. Objective
To identify system deficiencies (gaps) and propose improvement plan,
if any, in assuring the competence of laboratories of Kulumsa
agricultural research center, at Arsi zone of Oromia region.
3. Methodology of the Gap Analysis
The gap analysis was conducted by preparing a checklist on the
competence requirements of laboratories and ISO/IEC 17025:2005
checklist. Queries were made using these checklists and by conducting
discussions and interviews with laboratory personnel.
The available documentations were reviewed, different international
standards were referred, best practices benchmarked, and site visits
were conducted to objectively investigate the competence of the
laboratories. Reporting of the findings is presented in four sections:
1. where the laboratory is expected to reach (best practice)
2. what is observed (assessment findings)
3. what are the strengths
4. finally pointing the opportunities for improvement

GAP ANALYSIS REPORT
4.1 Best practice

GAP ANALYSIS REPORT
1. Personnel
The laboratory shall be an entity that can be held legally responsible. It
shall have managerial and technical personnel. It shall define the
organization and management structure of the laboratory, specify the
responsibility, authority and interrelationships of all personnel (maintain
current job descriptions). It shall have technical management, appoint a
member of staff as quality manager. Laboratory personnel shall be
qualified on the basis of appropriate education, training, experience
and/or demonstrated skills, as required.
2. Accommodation and environmental conditions
Laboratory facilities shall facilitate correct performance of the tests
including but not limited to energy sources, lighting and environmental
conditions. The laboratory shall monitor, control and record
environmental conditions as required by the relevant specifications,
methods and procedures or where they influence the quality of the
results. Due attention shall be paid, for example, to biological sterility,
dust, electromagnetic disturbances, radiation, humidity, electrical supply,
temperature, and sound and vibration levels, as appropriate to the
technical activities concerned. There shall be effective separation
between neighboring areas in which there are incompatible activities.
Access to and use of areas affecting the quality of the tests shall be
controlled. Measures shall be taken to ensure good housekeeping in the
laboratory. Special procedures shall be prepared where necessary.
3. Test methods and method validation
The laboratory shall use appropriate methods and procedures for all
tests within its scope. These include sampling, handling, transport,
storage and preparation of items to be tested and, where appropriate,
an estimation of the measurement uncertainty as well as statistical
techniques for analysis of test. The laboratory shall have instructions
on the use and operation of all relevant equipment, and on the
handling and preparation of items for testing where the absence of
such instructions could jeopardize the results of tests and/or
calibrations. All instructions, standards, manuals and reference data
relevant to the work of the laboratory shall be kept up to date and
shall be made readily available to personnel.

GAP ANALYSIS REPORT
Methods published in international, regional or national standards
shall preferably be used. The laboratory shall ensure that it uses the
latest valid edition of a standard unless it is not appropriate or
possible to do so.
The laboratory shall confirm that it can properly operate standard
methods before introducing the tests. The laboratory shall validate
non-standard methods, laboratory-designed/developed methods,
standard methods used outside their intended scope, and
amplifications and modifications of standard methods to confirm that
the methods are fit for the intended use.
Where applicable, the laboratory shall estimate uncertainty of
measurement.
4. Equipment
The laboratory shall be furnished with all items of sampling,
measurement and test equipment required for the correct performance of
the tests. Equipment and its software used for testing and sampling shall
be capable of achieving the accuracy required and shall comply with
specifications relevant to the tests concerned.
Calibration programs shall be established for key quantities or values of
the instruments. Equipment (including that used for sampling) shall be
calibrated or checked to establish that it meets the laboratory's
specification requirements and complies with the relevant standard
specifications. It shall be checked and/or calibrated before use. Each
item of equipment and its software shall be uniquely identified.
Equipment shall be operated by authorized personnel. The laboratory
shall have procedures for safe handling, transport, storage, use and
planned maintenance of measuring equipment.
Whenever practicable, all equipment under the control of the laboratory
and requiring calibration shall be labelled, coded or otherwise identified
to indicate the status of calibration, including the date when last
calibrated and the date or expiration criteria when recalibration is due.
When equipment goes outside the direct control of the laboratory, it shall
be checked and shown to be satisfactory before the equipment is
returned to service.
When intermediate checks are needed to maintain confidence in the
calibration status of the equipment, these checks shall be carried out
according to a defined procedure.

GAP ANALYSIS REPORT
Where calibrations give rise to a set of correction factors, the laboratory
shall have procedures to ensure that copies (e.g. in computer software)
are correctly updated. Test equipment, including both hardware and
software, shall be safeguarded from adjustments which would invalidate
the test results.
5. Measurement traceability (Reference standards and reference
materials)
All equipment used for tests including equipment for subsidiary
measurements (e.g. for environmental conditions) having a significant
effect on the accuracy or validity of the result of the test or sampling
shall be calibrated before being put into service. The laboratory shall
have an established programme and procedure for the calibration of its
equipment.
Note: Such a programme should include a system for selecting, using,
calibrating, checking, controlling and maintaining measurement
standards, reference materials used as measurement standards, and
measuring and test equipment used to perform tests.
6. Sampling
The laboratory shall have a sampling plan and procedures for sampling
when it carries out sampling of substances, materials or products for
subsequent testing. The sampling plan as well as the sampling procedure
shall be available at the location where sampling is undertaken.
Sampling plans shall, whenever reasonable, be based on appropriate
statistical methods. The sampling process shall address the factors to be
controlled to ensure the validity of the test results.
The laboratory shall have procedures for recording relevant data and
operations relating to sampling that forms part of the testing that is
undertaken. These records shall include the sampling procedure used, the
identification of the sampler, environmental conditions (if relevant) and
diagrams or other equivalent means to identify the sampling location as
necessary and, if appropriate, the statistics the sampling procedures are
based upon.

GAP ANALYSIS REPORT
7. Handling of test items
The laboratory shall have procedures for the transportation, receipt,
handling, protection, storage, retention and/or disposal of test items,
including all provisions necessary to protect the integrity of the test item,
and to protect the interests of the laboratory and the customer.
The laboratory shall have a system for identifying test items. The
identification shall be retained throughout the life of the item in the
laboratory. The system shall be designed and operated so as to ensure
that items cannot be confused physically or when referred to in records
or other documents. The system shall, if appropriate, accommodate a
sub-division of groups of items and the transfer of items within and from
the laboratory.
Upon receipt of the test item, abnormalities or departures from normal or
specified conditions, as described in the test method, shall be recorded.
When there is doubt as to the suitability of an item for test, or when an
item does not conform to the description provided, or the test required is
not specified in sufficient detail, the laboratory shall consult the
customer for further instructions before proceeding and shall record the
discussion.
The laboratory shall have procedures and appropriate facilities for
avoiding deterioration, loss or damage to the test item during storage,
handling and preparation. Handling instructions provided with the item
shall be followed. When items have to be stored or conditioned under
specified environmental conditions, these conditions shall be maintained,
monitored and recorded. Where a test item or a portion of an item is to
be held secure, the laboratory shall have arrangements for storage and
security that protect the condition and integrity of the secured items or
portions concerned

GAP ANALYSIS REPORT
4.2 Assessment findings

GAP ANALYSIS REPORT
4.2.1. Seed Quality Research Laboratory
1. Personnel
Seed quality laboratory is part of the research laboratory of Kulumsa
research center from which it gets its legality. The laboratory has a
management staff and quality manager that is shared by other
laboratories of the research center. There is organization structure that is
generic to all EIAR across the country. The seed quality laboratory of
Kulumsa research center (KRC) is taken to be under the research
laboratories.
Currently, the laboratory has two staffs. One is working as seed assistant
researcher I who is working in the laboratory, in a time that is spared
from his masters studies, and the other is general field research assistant
whose main task is at the field.The education status and experience are
shown on the table below.
Table 1: Education and experience
Name Education Experience
Astawus Esatu BSC(plant science)
MSC student(seed science)
5 years
Chuchu Azene Diploma secretary
management
years
Trainings taken to enable the researchers achieve competence in the area
of test and research they are engaged in is provided below.
Astawus Esatu
- Farm management and seed quality
- Seed health
Chuchu Azene
- No training has so far been given
2. Accommodation and Environmental Condition
The general work flow of the seed quality research laboratory starts from
sample reception and registration, test sample preparation, analysis
(observation/identification), report and disposal. This involves the
storage of samples before and after analysis and conditioning of
germination room.

GAP ANALYSIS REPORT
Seed Quality research laboratory has only two rooms dedicated for
analysis(one for purity and the other for germination). The analysis
room is serving to conduct test, store sample, store media and reagent.
The room dedicated for germination is also used as sample storage.
A fridge is used as sample storage by switching off the power to
maintain room temperature.
3. Test Method and Method Validation
The seed quality research laboratory scope of tests are physical(purity,
component), physiological (germination, vigour), and genetics(purity –
phenol test). The laboratory uses international seed testing association
rules ISTA effective from 1 Jan 2014 and ES ISO standards, as a test
method on wheat. ISTA rules has 19 chapters out of which 17 are
testing methods and one sampling rules (method). The method includes
sections on the object (of the test), definitions (of terms used in the
chapter), general principles (for the test), apparatus (required for the
test), procedure (how to conduct the test), calculation and expression of
results (specific to each test), reporting results (how to report results
correctly on an ISTA certificate), and tolerances (statistical tables for use
in determining whether test results are acceptable or not acceptable).
4. Equipment
The laboratory is furnished with basic equipment that are needed for the
current operation of the laboratory. Some of the major equipment in this
laboratory are;
Table 2: List of major Equipment
Equipment Status Quantity
1 Microscope Operational 3
- 1 stereo
- 1compound
microscope
- 1 with display
2 Oven Operational 3
3 Fridge Operational 1
4 Moisture tester 2 operational
2 out of order
4
5 Divider Operational 3
6 Water distiller 1 operational 1

GAP ANALYSIS REPORT
7 Digital balance All but one are
operational,
5
8 Germination chamber New 2
9 Microwave oven New 2
10 Grinder Operational 1
11 Seives of size 0.3, 0.4,
0.5
Operational >10
12 Conductivity tester Operational 2
13 Seed counter Operational 2
The test equipment are labelled with unique identification by property
admin (stock management department). Equipment manufacturer’s
manuals are available. The laboratory has glass wares and other
measuring equipment adequate for the current activity
5. Measurement traceability( Reference standards and reference
materials)
Some of the equipment that could be calibrated includes fridge, ovens
and balance. Controlling equipment are check weights and thermometer.
6. Sampling
Samples are collected by clients or by laboratory personnel. The sample
is registered and prepared in to a test sample. Sampling equipment are
available probe and paper bag.
7. Handling Of Test Items
Sample is stored at analysis room in a fridge by disabling power. The
samples are identified with labeling.

GAP ANALYSIS REPORT
4.2.2. Pathology Research Laboratory
1. Personnel
Pathology laboratory is part of the research laboratory of Kulumsa
research center from which it gets its legality. The laboratory has a
management staff and quality manager that is shared by other
laboratories of the research center. There is organization structure that is
generic to all EIAR across the country. Pathology laboratory of Kulumsa
research center (KRC) is taken to be under the research laboratories as
shown below(fig 1).
Currently, the laboratory has three staffs where one is working as
assistant researcher I and two staffs working as laboratory technical
assistant II as per assignment letter issued. The education status and
experience are shown on the table below.
Table 3: Education and experience
Name Education Experience
Getnet Muche BSC (applied biology) 4 years
Girma Zewdie Diploma 17 years
Getenesh Demissie Certificate 28 years
Trainings taken to enable the researchers achieve competence in the area
of test and research they are engaged in is provided below.
Getnet Muche
- Theoretical and practical training on pest identification and
diagnosis
- Identification through molecular biotechnology, ELISA and
PCR technique
- Theoretical and practical training on microbial isolation,
identification and preservation
- Training on scientific paper and project writing
- Theoretical and practical training on quarantine pests of wheat
- Theoretical and practical training on wheat breading and
pathology
- SAS software training and scientific paper writing
- Training course on laboratory field experimentation data
collection and analysis

GAP ANALYSIS REPORT
Girma Zewdie
Getenesh Demissie
2. Accommodation and Environmental Conditions
The general work flow of the pathology research laboratory starts from
sample reception and registration, sample preparation( that involves
cutting sample into test sizes, washing and drying),culture, isolation and
incubation, and observation(identification). This involves the storage of
samples before and after pathogen identification, media preparation and
activities at green house.
Pathology laboratory has three rooms for testing and green house
facility to conduct its research activities. The rooms are used for
activities like sample storage, equipment storage, media and reagent
storage, sample and media preparation and test analysis. Currently,
Sample isolation room is over staffed with equipment like laminar flow,
incubator and dry oven Analysis room serves as analysis room, sample
store, media and reagent preparation and store. There are also deep
freezer and out of order incubator. The isolation room is staffed with
equipment, serves as sample preparation and inoculation. Waste test
samples are stored in an incubator that goes out of order
3. Test Methods and Method Validation
The pathology laboratory scope of tests are wheat stem, root and leaf
for yellow and rust analysis. The laboratory uses CIMMYT, seed
testing of maize and wheat a laboratory guide, as a test method for
the identification of fungal pathogens of wheat root, stem and leaf.
The actual testing activity or method involves the collection of stem
or leaf sample, preparing the sample for the test activity, culturing,
inoculation and incubation, preservation, observation and reporting.
The CIMMYT as a test method is referred for only the identification
of the species of fungus on wheat stem, root or leaf. The method is
specifically suited for seed test.
4. Equipment
The laboratory is furnished with basic equipment that are needed for the
current operation of the laboratory. Some of the major equipment in this
laboratory are;

GAP ANALYSIS REPORT
Table 4: Lists of major equipment
Equipment Status Quantity
1 Microscope operational 9
- 3 stereo
- 5
compound/light
microscope
- 1 unicular
2 Deep freezer operational 1
3 Fridge operational 3
4 Incubator operational 1
5 Laminar flow operational 1
6 Water distiller 1 operational
1 out of order
1
7 Autoclave 1 operational,
1 not in operation
1
8 Water bath Operational 1
9 Balance operational 1
The test equipment are labelled with unique identification by property
admin(stock management department). Equipment manufacturer’s
manual are available. The laboratory has glass wares and other
measuring equipment adequate for the current activity. Observation
made with the current microscope is caught with hand drawing to
compare it with picture catalogues for pathogen identification.
5. Measurement Traceability( Reference Standards and Reference
Materials)
Some of the equipment that could be calibrated includes deep freezer,
fridge, incubator, autoclave, water bath and balance. Controlling
equipment are check weights and thermometer. Pictures from reference
books are used as a reference material for identification.
6. Sampling
Samples are collected by clients or by laboratory personnel. The sample
is registered and prepared in to a test sample.

GAP ANALYSIS REPORT
7. Handling of Test Items
Sample is stored at analysis room in a fridge. The fridge is also used as
strain retention(storage). The samples are identified with labeling.

GAP ANALYSIS REPORT
4.2.3. Nutrition Research Laboratory
1. Personnel
a. Job descriptions
The institute has prepared job descriptions for the different positions in
its structure. The existing laboratory staff is provided with a job
description up on recruitment.
However, the job description is not current and does not specify the
responsibilities with respect to
 performing tests and/or calibrations;
 the planning of tests and/or calibrations
 evaluation of results;
 for reporting opinions and interpretations;
 method modification and development and validation of new
methods;
 qualifications and training programs; and
 managerial duties.
b. Number of staff
The allocation of laboratory personnel to a laboratory depends on the
sample load, urgency of test requests, technology used in the laboratory,
and technical capability of personnel. Based on the above factors,
laboratory management need to assign adequate number of managerial,
technical and support personnel to a laboratory. These laboratory
personnel may be permanent, temporary, and/or contract staffs.
There is only one technical staff doing all managerial, technical and
support activities. This may be appropriate for the current workload in
the laboratory. However, considering the risk of depending solely on an
individual staff, additional laboratory personnel either as permanent,
temporary, or contract staffs will be a strategic decision.

GAP ANALYSIS REPORT
c. Educational Qualification
Educational qualification required in a laboratory depends on the
complexity of the works undertaken and the degree of responsibilities
given to personnel concerning interpretation of results and
recommendations.
The laboratory has defined requirements for educational qualification.
The person assigned to the laboratory has attained bachelor’s degree in
science. There is a continual educational qualification development
program in the EIAR system. Hence, there is a probability for the
existing laboratory personnel leave the laboratory for further study.
Therefore, additional or backup staffs(S) need to be thought.
Qualification requirements for key support personnel are not defined.
d. Experience
The requirements for experience depend on the complexity and
methodology employed for the test activities and the responsibilities
given to personnel regarding interpretation of test reports and provision
of recommendations based on the test reports. As laboratory activities
are technical and practical, experience plays the major role in bringing
about the required skill and in troubleshooting.
The existing laboratory staff has only about two years of professional
experience and of which he has few months of practical experience on
the test methods and the associated instrument.
EIAR has developed a career structure to retain experienced laboratory
staffs.
e. Trainings
The theoretical knowledge and practical expertise gained at the time of
graduation are not sufficient to the current activities the laboratory
performs and the level of technology employed.
The laboratory staff has taken trainings only on proximate (moisture, fat,
protein, fiber,, and ash) analyses that do not form part of the test
activities of the laboratory. This staff has also exposure to techniques of
NIR and glutamic system during installation of these instruments.

GAP ANALYSIS REPORT
Trainings are not provided to the staff on operations (and determination)
of
 Falling number
 Single kernel characterization
 Glutamic system
 Miller (for sample preparation)
 Atomic Absorption Spectrometer (for mineral analyses)
Further trainings are needed on
 Quality assurance/quality control activities
 Statistical techniques
 Validation/verification of methods
 Determination of uncertainty of measurements
 Quality management system requirements
 Operation of test instruments
a. Identified environmental factors and means of controlling
For the current activities in the laboratory, the environmental conditions,
such as temperature, relative humidity, light intensity, dust, and sound
are considered insignificant factors. However, vibration due to the
operation of millers may have impact on the correct performance of
balances. Even though there is a standby generator, there is no means to
ensure continuous supply of electrical power for the correct performance
of instrument (e.g., NIR).
b. laboratory design and workflow
The laboratory has enough space for the test activities it undertakes.
There are four rooms in the laboratory and only one of these rooms is
furnished and all the big instruments are put in this room. With this
arrangement, the instruments are exposed to water spillage and there is a
high probability of cross-contamination.
The laboratory rooms are better to be rearranged in to
 Supplies store (room #1)

GAP ANALYSIS REPORT
 Wet chemistry (room #2)
 Sample preparation room(room#3)
 Corridor (room#4)
 Sample storage room(room #5)
 Instrumental room (room #6)
6 3 2
4
5
1
c. utilities
The laboratory is furnished with all the necessary utilities. There is
uninterrupted power and water supply, office, emergency shower room,
and toilets for men and women. Benches and water taps are supplied
only to the “wet chemistry room”. The water taps in this room are not
suitable for hoses of the instruments and need to be changed.
The other rooms in the laboratory need benches, shelves, drainage, and
electric outlets. The middle room needs to be partitioned into two rooms
separated by a corridor. The office room needs to be furnished with
necessary utilities.
d. access control
As the laboratory is isolated from other buildings and offices, there is
little concern for access control. If there is a need to limit access into the
laboratory, an electronic access control system can be built at the main
gate into the laboratory building.

GAP ANALYSIS REPORT
3. Methods And Methods Validation
a. Selection of methods
The methods used in the laboratory for analyses are standard
manufacturers’ methods and are considered appropriate for the intended
purpose.
Methods selection for wet chemistry in the future is better to be standard
and widely accepted and to use those methods that are simple to obtain
the latest version when required.
b. Validation/verification of methods
The methods in the laboratory are not validated/verified and need either
to be validated/verified depending on the availability capability data of
the methods.
The laboratory is expected to validate/verify the performance of the
methods by participating in inter-laboratory studies and in a ring test
with the manufacturer.
c. Uncertainty of measurement
The Uncertainty of measurement of the methods in the laboratory are not
determined and known. The laboratory needs to estimate the level of
uncertainties of all test methods preferably using Type B approach
(Heuristic estimates).
A. Equipment and Measurement Traceability
a. adequacy and measurement capability
The laboratory is furnished with major equipment for the test activities.
The measurement capabilities of the existing instruments are appropriate
for the test activities. However, the laboratory is not equipped with
equipment for wet analyses and there no balance in the laboratory.
b. calibration
None of the measuring and monitoring devices in the laboratory are
calibrated. There is also no program for equipment calibration.

GAP ANALYSIS REPORT
The equipment supplier calibrated the Near Infra-Red (NIR) only for
few parameters and commodity types. The calibration is needed for other
major crops e.g., faba bean for a wide range of parameters.
c. reference materials and reference standards
There are no reference materials for calibration of instruments in the
laboratory (e.g., NIR, Falling number, Single kernel characterization,
Glutamic system).
There are no traceable reference materials (quality control samples) to
verify performance of the test processes.
d. intermediate checks for equipment and reference materials
Instruments for Falling number, Single kernel characterization and
Gluten content were calibrated by the supplier and there are no means
for intermediate checking and recalibration of these instruments.
e. preventive and corrective maintenance
Preventive measures and their frequency are stated in the instrument
manuals. However, the laboratory staff has no trainings and is not aware.
There is on preventive maintenance plan for all instruments in the
laboratory.
4. E. Sampling And Sample Management
a. sampling plan and sampling procedure
The laboratory is not involved in sampling.
b. sample management
Samples are not uniquely identified. The laboratory is using sample
codes provided by the customer that may confuse the samples.
Samples are put in paper bags and stored on the floor and on top of
workbenches that may result in cross-contaminations and sample
deterioration (due to insect infestations).
Sample preparation and storage rooms are better to be separated in order
to reduce the risk of cross-contamination. The sample storage room
needs deep freezer for long-time storage of samples.

GAP ANALYSIS REPORT
5. Quality Control/Quality Assurance
verify performance of the test processes using instruments in the
laboratory (e.g., NIR, Falling number, Single kernel characterization,
Glutamic system).
The laboratory is neither participating in inter-laboratory comparisons,
Proficiency testing schemes, nor using traceable reference materials for
the tests it performs.
As there are no reference materials, Shewart control charts are not
constructed and trends are not analyzed.
6. Purchasing of supplies
a. specifications
The laboratory uses published supplies specification.
b. verifications
Supplies verifications are done either by physical inspection or by
performance evaluation. The records are available at the head office.
c. stoke levels
The average annual consumption of supplies and the minimum stoke
levels required by the laboratory is not available.
d. store management
There is no room dedicated for supplies storage. Equipment spare parts
and consumables are kept in shelves of the workbenches.
The proposed supplies store needs to be furnished with shelves and
appropriate stock management system needs to be implemented.

GAP ANALYSIS REPORT
4.2.4. Soil, Plant and Water Analysis Laboratory
1. Personnel
a. Job descriptions
The existing laboratory staffs are provided with job descriptions up on
recruitment. However, the job description are not current and do not
specify the responsibilities with respect to
methods;
 qualifications and training programs; and managerial duties.
b. Number of staff
There are eight staffs in the laboratory and of which, six are technical
staffs and two are support personnel. The number of staffs is sufficient
for the current workload.
c. Educational Qualification
The laboratory has defined requirements for educational qualification.
Three of the personnel assigned to the laboratory have attained
bachelor’s degree in science, one staff has diploma and the others are
certificate holders.
There is a continual educational qualification development program in
the EIAR system. Hence, there is a probability for the existing laboratory
personnel leave the laboratory for further study. Therefore, additional or
backup staffs(S) need to be thought.

GAP ANALYSIS REPORT
d. Experience
The existing laboratory staffs have 2-40 years of practical experience on
the test methods. However, the laboratory staffs are not familiar with the
modern technologies introduced in to the laboratory (e.g., AAS, UV-Vis
spectrometer, flame photo meter).
EIAR has developed a career structure to retain experienced laboratory
staffs.
e. Trainings
The theoretical knowledge and practical expertise gained at the time of
graduation and from experience are not sufficient to the current activities
the laboratory performs and the level of technology employed.
Trainings are not provided to the staff on operations (and determination)
of
 Atomic Absorption Spectrometer
 Flame photometer
 UV-Visible spectrometer
Further trainings are needed on
 Quality assurance/quality control activities
 Statistical techniques
 Validation/verification of methods
 Determination of uncertainty of measurements
 Quality management system requirements
 Operation of test instruments

GAP ANALYSIS REPORT
A. Identified environmental factors and means of controlling
For the current activities in the laboratory, the environmental conditions,
such as temperature, relative humidity, light intensity, dust, and sound
are considered insignificant factors. However, the temperature and
humidity in the sample preparation room has to be controlled. Even
though there is a standby generator, there is no means to ensure
continuous supply of electrical power for the correct performance of
instrument (e.g., AAS).
B. laboratory design and workflow
The laboratory has enough space for the test activities it undertakes.
Workbenches are not readily available (expected to receive sooner). The
laboratory floors, walls, ceilings, and layout are in a way to facilitate
correct performance of activities.
Sample preparation room is not suitable to the proper performance of
activities. There is a possibility of cross-contamination and loss of
sample properties. The room needs to be renovated into
 Sample grinding room (room #1)
 Sample drying room (room #2)
 Sample storage room (room# 3)
1 2 3
C. utilities
The laboratory is furnished with all the necessary utilities. There is
uninterrupted power and water supply, office, emergency shower room,
and toilets for men and women.
D. access control
As the laboratory is isolated from other buildings and offices, there is
little concern for access control. If there is a need to limit access into the
laboratory, an electronic access control system can be built at the main
gate into the laboratory building.

GAP ANALYSIS REPORT
3. Methods and Methods Validation
a. Selection of methods
The methods used in the laboratory for analyses are non-standard
methods (national soil laboratory manual).
standard and widely accepted methods are better to be used. It is simple
to obtain the latest versions of these methods when required.
b. Validation/verification of methods
The methods in the laboratory are not validated and need r to be
validated.
c. Uncertainty of measurement
The Uncertainty of measurement of the methods in the laboratory are not
determined and known. The laboratory needs to estimate the level of
uncertainties of all test methods preferably using Type B approach
(Heuristic estimates).
4. Equipment and Measurement Traceability
a. adequacy and measurement capability
The laboratory is furnished with major equipment for the test activities.
The measurement capabilities of the existing instruments are appropriate
for the test activities.
b. calibration
Measuring and monitoring devices in the laboratory were not calibrated
for about two years. There is also no program for equipment calibration.
c. reference materials and reference standards
There are no certified reference materials for calibration of instruments
in the laboratory (e.g., AAS, Flame photometer, PH).
verify performance of the test processes.

GAP ANALYSIS REPORT
d. intermediate checks for equipment and reference materials
There are no traceable reference materials (thermometers, check
weights, certified reference materials, etc)
e. preventive and corrective maintenance
Preventive measures and their frequency are stated in the instrument
manuals. However, the laboratory staffs have no trainings and are not
aware. There is no preventive maintenance plan for all instruments in the
laboratory.
5. Sampling and Sample Management
a. sampling plan and sampling procedure
The laboratory is not involved in sampling.
b. sample management
Samples are uniquely identified. Samples are put in plastic bags and
stored on dedicated shelves.
Sample preparation room is better to be renovated in order to reduce the
risk of cross-contamination. The sample storage room needs deep freezer
for long-time storage of samples.
6. Quality Control/Quality Assurance
There are no traceable certified reference materials (quality control
samples) to verify performance of the test processes using instruments in
the laboratory (e.g., AAS, Flame photometer).
The laboratory is neither participating in inter-laboratory comparisons,
Proficiency testing schemes, nor using traceable reference materials for
the tests it performs.
As there are no trace reference materials, Shewart control charts are not
constructed and trends are not analyzed.

GAP ANALYSIS REPORT
7. Purchasing of Supplies
a. specifications
The laboratory uses published supplies specification.
b. verifications
Supplies verifications are done either by physical inspection or by
performance evaluation. The records are available at the head office.
c. stoke levels
The average annual consumption of supplies and the minimum stoke
levels required by the laboratory is not available.
d. store management
There is a well-managed store for supplies. The stoke level is controlled
by the use of bin cards.
Expired and unexpired chemicals are identified and are kept isolated.
Chemicals are stored in a way to avoid danger and cross-contamination.

GAP ANALYSIS REPORT
4.3. Strengths

GAP ANALYSIS REPORT
1. Personnel
The research center is organized in a way to support the seed quality
laboratory . Such organization has
- Management staff that supports the laboratory with the needed
resources
- Quality manager
- Research personnel for laboratory testing activity
- Researcher with the appropriate education to expand the scope
of testing activity in the areas of seed health.
There is a standby generator to continue tests in case of power cut.
Walls, buildings, floor and ceiling are in good repair. Shelves are
available for storage. The laboratory is provided with power sources and
water source. Generally equipment are placed with access to
maintenance and cleaning at analysis room.
Method selection is appropriate to the field of testing and research
conducted. The laboratory conducts three out of the four quality
attributes of seed (physical, physiological and genetics). Proclamations
pertaining to seed quality is identified and used.
4. Equipment
Equipment are labelled and identified. Most of the basic equipment for
the current operation are available. Most of the equipment are
operational.
5. Measurement Traceability( Reference Standards and
Reference Materials)
Availability of intermediate check and measuring equipment.
6. Sampling
Sample taken is registered in to a log book. The laboratory uses ISTA
sampling method.

GAP ANALYSIS REPORT
The test items are registered and bear labels for identification.

GAP ANALYSIS REPORT
1. Staffing
The research center is organized in a way to support the pathology
laboratory . Such organization has
- Management staff that supports the laboratory with the needed
resources
- Quality manager
- Research personnel for laboratory testing activity
- Trained researcher to expand the scope of testing activity in the
areas of pest identification, and microbial isolation,
identification and preservation.
There is a standby generator to continue tests in case of power cut.
Walls, buildings, floor and ceiling are in good repair. Three separate
rooms that could be rearranged to accommodate and separate
incompatible activities. The laboratory is provided with power sources
and water source.
The laboratory practices good microbial techniques in the identification
of fungal pathogens. The tests conducted are selected based on the
current main problem of farms in Assela area.
4. Equipment
Equipment are labelled and identified. Most of the basic equipment for
the current operation are available. Most of the equipment are
operational.
5. Measurement Traceability (Reference Standards and
Availability of intermediate check and measuring equipment.
6. Sampling
Sample taken is registered in to a log book. Sampling equipment and

GAP ANALYSIS REPORT
substrate(glycine paper) are available.
The test items are registered and bear labels for identification.

GAP ANALYSIS REPORT
1. Personnel
 Job description is available
 There are adequate numbers of staff for the current activities in the
laboratory.
 Personnel development programs are established
 Most of the environmental conditions have little impact on the test
process
 Utilities are available and acceptable.
 Access to the laboratory is not a problem.
 The methods in use in the laboratory are standard.
 All equipment are functional
 Instrument manuals are readily available
5. Purchasing
 Specification documents are available
 Supplies are verified

GAP ANALYSIS REPORT
4.3.4. Soil, Plant, and Water Analysis Laboratory
1. Personnel
 Job description is available
 There are adequate number of staff for the current activities in the
laboratory.
 Personnel development programs are established
 Most of the environmental conditions have little impact on the test
process
 Utilities are available and acceptable.
 Access to the laboratory is not a problem.
 All equipment are functional
 Instrument manuals are readily available
4. Purchasing
Specification documents are available
Supplies are verified

GAP ANALYSIS REPORT
4.4. Opportunity for improvement

GAP ANALYSIS REPORT
1. Staffing
The research laboratory has the following opportunities for improvement
to achieve a level of competence that is required by international
standards regarding its organization.
- The research laboratory could define an organization structure
that could describe the specific management of KRC and the
Seed Quality Research laboratory.
- Current job description could be provided to research personnel
regarding their duties, responsibilities, authorities and
requirements for the job.
- Trainings could be provided to upgrade current performance
and future scope of service expansion to all staff.
- Staff could be proved competent in the areas of tests they are
engaged in.
- Laboratory research personnel could be assigned to manage
tests full time.
Considering the work flow in the laboratory, the accommodation and
environmental condition at the laboratory could be improved by
- Isolating the different activities that are incompatible. The
sample preparation, sample storage,
identification/germination(analysis), media and reagent
storage could be isolated to avoid potential cross
contamination.
- Fulfilling the power requirements of germination chamber and
water distiller.
- Avoiding those equipment that are not in use from the
laboratory.
- controlling the appropriate temperature and moisture of storage
areas.
- Fulfilling the light supply requirements and control of
appropriate temperature and humidity of germination room
- Moving the laboratory in to an area where there are enough
room to isolate the different incompatible activities, such as
the new facility.
- Commissioning the new germination chamber for germination

GAP ANALYSIS REPORT
test than using a room with lower control.
- establishing a house keeping procedure and taking records.
The seed quality research laboratory has the potential to expand its
services not only to physical, physiological and genetics but also to seed
health. The testing technique could be improved by
- Defining validation techniques of these methods and validating
before use.
- an estimation of the measurement uncertainty.
- Updating the ISTA rule of 2014 to the amended current rules
(2016).
4. Equipment
The laboratory could provide a better service with the following
equipment and practice improvements.
- Relocating equipment that are not currently in use
- Documentation and record of equipment full identity, maintenance
and calibration status.
- Availability of PH
meter and its standard.
- Establishing maintenance and calibration programs and execution
based on this plan.
- To verify equipment of its performance capability
- To train employees on equipment operation and authorize use.
- Preparation of equipment procedure for safe handling, transport,
storage, and use.
- Sample store compartments could be added to accommodate more
sample storage.
- Commissioning germination chamber in to operation.
- Availing deep freezer, autoclave and micro flow for some present
operations and future scope extension on seed health tests.
5. Measurement Traceability(Reference Standards and Reference
Materials)
Equipment for tests and intermediate checking could be calibrated before
putting in to operation. This could be handled by establishing a program
and a procedure. Reference microorganisms could be bought and used to
establish traceability for future scope extension on seed health.

GAP ANALYSIS REPORT
6. Sampling
Activities and conditions during sampling could be recorded to assure
the validity of tests.
The laboratory could consider a better sample handling by
- Preparation of procedure for sample handling including
transportation, receipt, handling, protection, storage, retention
and/or disposal of test items.
- Dedicating a separate sample storage area with controllable
environmental conditions.
- Monitoring the environmental requirements of the sample storage
area.

GAP ANALYSIS REPORT
1. Personnel
The research laboratory has the following opportunities for improvement
to achieve a level of competence that is required by international
standards regarding its organization.
- The research laboratory could define an organization structure
that could describe the specific management of KRC and the
pathology laboratory.
- Current job description could be provided to research personnel
regarding their duties, responsibilities, authorities and
requirements for the job.
- Trainings could be provided to upgrade current performance
and future scope of service expansion to all staff.
Considering the work flow in the laboratory, the accommodation and
environmental condition at the laboratory could be improved by
- Isolating the different activities that are incompatible. The
sample preparation, sample storage, incubation and
identification(analysis), media and reagent storage could be
isolated to avoid potential cross contamination.
- Avoiding those equipment that are not in use from the
laboratory.
- controlling the appropriate temperature and moisture of storage
areas, establishing a house keeping procedure and taking
records.
The pathology laboratory has the potential to expand its services not
only to fungal pathogens but also bacteria, nematodes and others that
could affect wheat. The scope of tests can be expanded. The testing
technique could be improved by
- Selecting a test method that is suitable for root, stem and leaf tests
that defines the procedures used to sampling, handling, transport,
storage and preparation of items to be tested and, where
appropriate, an estimation of the measurement uncertainty as well
as statistical techniques for analysis of test.
- Defining validation techniques of these methods and validating
before use.

GAP ANALYSIS REPORT
4. Equipment
The laboratory could provide a better service with the following
equipment and practice improvements.
- Relocating equipment that are not currently in use
- Documentation and record of equipment full identity, maintenance
and calibration status.
- Availability of PH
meter, microliters and microscope with picture
display, oven etc
- Establishing maintenance and calibration programs and execution
based on this plan.
- To verify equipment of its performance capability
- To train employees on equipment operation and authorize use.
- Preparation of equipment procedure for safe handling, transport,
storage, and use
5. Measurement Traceability (Reference Standards and
Equipment for tests and intermediate checking could be calibrated before
putting in to operation. This could be handled by establishing a program
and a procedure. Reference microorganisms could be bought and used to
establish traceability.
6. Sampling
Sampling could be improved by preparing sampling procedure by
employing appropriate statistical method. Activities and conditions
during sampling could be recorded to assure the validity of tests.
Sampling bag/box could be improved.
The laboratory could consider a better sample handling by
- Preparation of procedure for sample handling including
transportation, receipt, handling, protection, storage, retention
- Dedicating a separate sample storage area with controllable
environmental conditions.
- Monitoring the environmental requirements of the sample storage
area.

GAP ANALYSIS REPORT
1. Personnel
a. Prepare current job description specifying the responsibilities with
respect to
methods;
b. Considering the risk of depending solely on an individual staff,
additional laboratory personnel either as permanent, temporary, or
contract staffs will be a strategic decision.
c. Define Qualification requirements for key support personnel
d. Further trainings are needed on
o Quality assurance/quality control activities
o Statistical techniques
o Validation/verification of methods
o Determination of uncertainty of measurements
o Quality management system requirements
o Instruments operations
 Prepare stable (preferably concrete made) stand for the
balance.
 Procure a stabilizer for the NIR
 Furnish laboratory rooms with benches, shelves, drainage,
and electric outlets
 Rearrange the laboratory rooms in to
 Supplies store (room #1)
 Wet chemistry (room #2)
 Sample preparation room(room#3)
 Corridor (room#4)

GAP ANALYSIS REPORT
 Sample storage room(room #5)
 Instrumental room (room #6)
6 3 2
4
5
1
3. Methods Validation
 The laboratory is expected to validate/verify the performance
of the methods by participating in inter-laboratory studies and
in a ring test with the manufacturer.
 Estimate the level of uncertainties of all test methods
preferably using Type B approach (Heuristic estimates).
4. Equipment And Measurement Traceability
 Procure balances, thermometers, and other instruments
needed for the test activities.
 Get all measuring and monitoring equipment calibrated.
 Procure reference materials and reference standards for
instrument calibrations and quality control activities.
 Plan preventive maintenances for instruments
5. Sample Management
 Establish coding system for the samples
 Arrange and furnish sample storage and preparation rooms.
 Avail fridge for the sample storage room
6. Quality Assurance
 Purchase traceable references (quality control samples) to
verify performance of the test processes using instruments
in the laboratory (e.g., NIR, Falling number, Single kernel
characterization, Glutamic system).
 Participating in inter-laboratory comparisons, Proficiency
testing schemes, or use traceable reference materials for
tests.
 Monitor trends by constructing control charts.

GAP ANALYSIS REPORT
7. Purchasing
 Determine the average annual consumption of supplies and
the minimum stoke levels required by the laboratory.
 Furnished the proposed supplies store with shelves and
implement appropriate stock management system.

GAP ANALYSIS REPORT
4.4.4. Soil, Plant and Water Analysis Laboratory
1. Personnel
a. Prepare current job description specifying the responsibilities
with respect to
methods;
b. Define Qualification requirements for key support personnel
c. Further trainings are needed on
o Quality assurance/quality control activities
o Statistical techniques
o Validation/verification of methods
o Determination of uncertainty of measurements
o Quality management system requirements
o Instruments operations
 Procure a stabilizer for the AAS
 Furnish laboratory rooms with benches, shelves, drainage,
and electric outlets
 Renovate sample preparation room in to
o Sample grinding room (room #1)
o Sample drying room (room #2)
o Sample storage room (room# 3)
1 2 3

GAP ANALYSIS REPORT
3. Methods Validation
o Use standard and widely accepted methods.
o Validate the methods in use.
o Estimate the level of uncertainties of all test methods
preferably using Type B approach (Heuristic estimates).
 Get all measuring and monitoring equipment calibrated.
 Procure reference materials and reference standards for
instrument calibrations and quality control activities.
 Plan preventive maintenances for instruments
5. Sample management
 Arrange and furnish sample storage and preparation rooms.
 Avail fridge for the sample storage room
6. Quality Assurance
 Purchase traceable references (quality control samples) to
verify performance of the test processes using instruments in
the laboratory (e.g., AAS, Flame photometr, UV-Vis).
 Participating in inter-laboratory comparisons, Proficiency
testing schemes, or use traceable reference materials for tests.
 Monitor trends by constructing control charts.
7. Purchasing
 Determine the average annual consumption of supplies and
the minimum stoke levels required by the laboratory.

GAP ANALYSIS REPORT
4. SWOT ANALYSIS
Finding from SWOT analysis has extracted the strength, weakness,
opportunity and threat from the management perspective and described
below.
Strength
- lab renovation, good commitment of the workers
- good lab equipment
- equipment are calibrated, certificate
- documentation(completing ISO/IEC 17025)
- experienced lab technicians
- automatic electric source/stand by
- good location , suitable condition and unaffected by external
factors
- reporting on-time
- good communication
- good service, ready to improve
- job covering(work also instead of support staffs)
- good handling of the lab
- making the lab clear
- good service providing for customers even though it is loaded
- on the preparation process for obtaining accreditation
- presence of quality manual and procedures
Weaknesses
- not accredited lab but on the process
- lack of lab support staff members like custodian and chemical store
personnel
- lack of training on the new lab equipment like AAS,UV-VIS
Spectrophotometer & Automatic Flame Photometer
- lack of senior lab researchers

GAP ANALYSIS REPORT
- shortage of budget
- lack of sample preparation room for the lab itself
- not enough office rooms
- no Certified Reference Materials (CRM)
Opportunities
- consulting bodies available
- good weather
- communication with universities and factories(Arsi University,
Asela Malt Factory, Chilalo Food Complex Factory...)
- good environment
- good partnerships among the staff workers and others
- linkage needs from Arsi University to work cooperatively
- good lab utilities (electric, water)
Threats
- work load on the technical lab workers due to the absence of
laboratory chemical store person, laboratory custodian
- the number of customers increased from time to time but the lab
has no enough workers
- no senior lab researcher
- no skilled personnel for equipment maintenance
- internet problem
- shortage of financial backing or support or help
The threats identified will be tackled with the strengths of the research
center. Weaknesses will be curbed with the opportunities. The actions to
be taken to avoid threats and do away weaknesses are presented on the
proposed action plan, Annex 1,2, 3 & 4.

GAP ANALYSIS REPORT
5. PROPOSED ACTIONS PLAN
The management system of Kulumsa research laboratory center has been
working and satisfying the needs of the research community and
interested parties. This gap analysis is conducted to point out
opportunities for improvement to upgrade the quality of service rendered
by the laboratory to a level that is acceptable internationally. To this
effect, we have assessed the facility from the perspective of the
international standard ISO/IEC 17025:2005 and best practices in the
field. The gaps and recommended action (action plan) is annexed.
6. CONCLUSIONS AND RECOMMENDATIONS
The research laboratories have laid foundations for providing competent
services if they are supported to work as per internationally accepted
norms. The appropriate international standard to bring about such
competency level is proposed to be ISO/IEC 17025:2005. Currently, the
laboratories are providing limited scope of services to its clients. Some
additional scopes can be developed with the commitment of some
human and material resources. To this effect, laboratories could be
supported in two phases or a combination of both. The first phase could
be supporting the laboratories technically and materially to capacitate the
current scope of tests towards competency based on ISO/IEC 17025. The
second phase could be identifying the needs of clients, identifying the
test method (fulfilling equipment, environmental requirement, personnel
and consumables), designing and practicing its management and
introducing the method for service as per the requirements of ISO/IEC
17025.
The seed quality laboratory has the basic resources to extend its scope of
services that could give value for its clients. Such extension may
consider seed health tests. The management and technical
documentations identified in the current operation as gap can also be
employed to such scopes. The scope can easily be developed with the
existing equipment with the addition of micro flow, autoclave, and deep
freezer as major equipment need. The human resource can also be
developed by providing on job training. Consumables like media and
reference material for the scopes to be decided upon can be obtained.
The pathology laboratory has the basic resources to extend its scope of
services that could give value for its clients. Such extension may
consider bacteriological and nematode identification. The management
and technical documentations identified in the current operation as gap

GAP ANALYSIS REPORT
can also be employed to such scopes. The scope can easily be developed
with the existing equipment with the addition of only two incubators.
The human resource can also be developed by providing on job training.
Consumables like media and reference material for the scopes to be
decided upon can be obtained.

GAP ANALYSIS REPORT
ANNEXES
The action plan annexed shows the duration of individual tasks and does not depict the total time that it takes to accomplish filling
the gaps identified.

GAP ANALYSIS REPORT
Annex: 1 Action plan for seed quality research laboratory
Area N
o
Gaps identified Recommended action Estimated duration for
action
Month
1 2 3 4 5 6 7 8 9 10
Staffing
1 An organization structure that could describe the
specific management of KRC and the pathology
laboratory.
Refining the existing job description in a
way that supports the management and
operation of the laboratory.
2 Current job description defining research
personnel regarding their duties, responsibilities,
authorities and requirements for the job.
Issuing job description to each
management and technical personnel as
per ISO/IEC 17025 requirement.
3 Trainings to upgrade current performance and
future scope of service expansion to all staff.
Provision of training on
ISO/IEC 17025
Validation and UoM
Internal auditing
Quality assurance
On job trainings for seed quality testing
techniques.
Assessment of training needs after
determining scope extension and
provision of on job training in line with
the type of scope added.

GAP ANALYSIS REPORT
Area N
o
action
Month
1 2 3 4 5 6 7 8 9 10
Accommodationandenvironmentalcondition
1 Some activities are incompatible. The sample
preparation, sample storage, incubation and
identification(analysis), media and reagent
storage are not isolated from each other and pose
potential cross contamination.
Segregation of processes in to different
areas as far as resources permit.
Activities that should be separated are
Sample storage and preparation
Analysis /incubation
Sterilization room (Oven/autoclave)
Media and reagent storage
2 Some equipment that are not in use are not
labelled nor segregated
Establishing equipment handling
procedure and record as per ISO/IEC
17025. Taking measure as per the
procedure.
3 Environmental monitoring on temperature and
moisture of storage areas.
Housekeeping procedure and taking records.
Establishing environmental and
housekeeping procedure and monitoring.
4 Light, temperature and humidity requirement of
germination room
Fulfilling the light supply requirements
and control of appropriate temperature
and humidity of germination room
5 Potential cross contamination because of Moving the laboratory in to an area

GAP ANALYSIS REPORT
Area N
o
action
Month
1 2 3 4 5 6 7 8 9 10
overlapping activities in the same room. where there are enough room to isolate
the different incompatible activities, such
as the new facility.
6 Environmental condition maintenance is
difficult at germination room, not air tight.
Commissioning the new germination
chamber for germination test than using
a room with lower control.
Testmethod,Methodvalidation
andUoM
1 Current version of documents Updating the ISTA rule of 2014 to the
amended current rules (2016).
2 Validation of methods Defining validation techniques of these
methods and validating before use.
3 Measurement uncertainty Defining the technique for UoM and
determining UoM.
Equipment
1 Equipment procedure for safe handling,
transport, storage, and use.
Documentation and record of equipment
handling and record full identity,
maintenance and calibration status.

GAP ANALYSIS REPORT
Area N
o
action
Month
1 2 3 4 5 6 7 8 9 10
2 Equipment operation and use authorization. To train employees on equipment
operation and authorize use.
3 Equipment maintenance and calibration plan
with its execution
Establishing maintenance and calibration
programs and execution based on this
plan.
4 Equipment qualification To verify equipment of its performance
capability.
5 Equipment adequacy Availing of PH meter, autoclave, deep
freezer, micro flow.
Measurement
traceability
1 Intermediate checks for measuring equipment Interim check for autoclave, PH meter
2 Reference materials Reference microbes for the tests
conducted like
- bacterial CRM
- Fungal CRM

GAP ANALYSIS REPORT
Area N
o
action
Month
1 2 3 4 5 6 7 8 9 10
Sampling/testitemhandling
1 Monitoring the environmental requirements of
the sample storage area.
Preparation of procedure for sample
handling including transportation,
receipt, handling, protection, storage,
retention and/or disposal of test items.
Dedicating a separate sample storage
area with controllable environmental
conditions.
Documentations
1 Management system documentations Development of about 15 management
system level documents like
Document control
Record control
Internal audit
Control of non – conforming products
Corrective action
Preventive action
2 Operational documentations Development of about 10 technical

GAP ANALYSIS REPORT
Area N
o
action
Month
1 2 3 4 5 6 7 8 9 10
documents like
Personnel
Accommodation and environment
Test methods/validation
UoM
Equipment
Quality assurance
3 Quality system maintenance plan, their
execution and records
Action and records of Corrective action,
internal audit, management review,
customer feedback and analysis,
environmental and equipment
monitoring, equipment and consumables
qualification, calibration records, quality
control chart etc

GAP ANALYSIS REPORT
Annex: 2: Action plan for pathology research laboratory
Area N
o
Gaps identified Recommended action Estimated duration for action
Month
1 2 3 4 5 6 7 8 9 1
0
Staffing
laboratory.
Refining the existing job description in a way
that supports the management and
2 Current job description defining research personnel
regarding their duties, responsibilities, authorities
and requirements for the job.
Issuing job description to each management
and technical personnel as per ISO/IEC
17025 requirement.
ISO/IEC 17025
Validation and UoM
Internal auditing
Quality assurance
On job trainings for microbial techniques.
determining scope extension and provision
of on job training in line with the type of
scope added.

GAP ANALYSIS REPORT
identification(analysis), media and reagent storage
are not isolated from each other and pose potential
cross contamination.
areas as far as resources permit. Activities
that should be separated are
2 Some equipment that are not in use are not labelled
nor segregated
Establishing equipment handling procedure
and record as per ISO/IEC 17025. Taking
measure as per the procedure.
Testmethod,Methodvalidationand
UoM
1 Appropriate method for pathogen test on leafs,
stem and root.
Sampling method
Selecting a test method that is suitable for
root, stem and leaf tests that defines the
procedures used to sampling, handling,
transport, storage and preparation of items
to be tested.

GAP ANALYSIS REPORT
determining UoM.
Equipment
1 Equipment procedure for safe handling, transport,
storage, and use.
2 Equipment operation and use authorization. To train employees on equipment operation
and authorize use.
3 Equipment maintenance and calibration plan with
its execution
programs and execution based on this plan.
capability.
5 Equipment adequacy Availing of PH meter, microliters and
microscope with picture display.
Measurementtraceability
2 Reference materials Reference microbes for the tests conducted
like
- aspergillus spp
- Fusarium spp
- Bipolaris spp
Sampling
/testitem
handling
1 Sampling procedure Preparing sampling procedure by employing
appropriate statistical method
2 Monitoring the environmental requirements of the Preparation of procedure for sample

GAP ANALYSIS REPORT
sample storage area. handling including transportation, receipt,
handling, protection, storage, retention
Dedicating a separate sample storage area
with controllable environmental conditions.
Documentations
Document control
Record control
Internal audit
Corrective action
Preventive action
documents like
Personnel
UoM
Equipment
Quality assurance

GAP ANALYSIS REPORT
3 Records Records of Corrective action, internal audit,
management review, customer feedback
and analysis, environmental and equipment
control chart etc

GAP ANALYSIS REPORT
Annex: 3: Action plan for Nutrition Research laboratory
Area N
o
Month
1 2 3 4 5 6 7 8 9 1
0
Staffing
laboratory.
17025 requirement.
ISO/IEC 17025
Validation and UoM
Internal auditing
Quality assurance

GAP ANALYSIS REPORT
scope added.
nor segregated
Testmethod,Method
validationandUoM
stem and root.
Sampling method
to be tested.

GAP ANALYSIS REPORT
determining UoM.
Equipment
storage, and use.
and authorize use.
its execution
capability.
like
- aspergillus spp
- Fusarium spp
- Bipolaris spp
Sam
pling
/test
item
han
dling

GAP ANALYSIS REPORT
2 Monitoring the environmental requirements of the
sample storage area.
handling including transportation, receipt,
Documentations
Document control
Record control
Internal audit
Corrective action
Preventive action
documents like
Personnel

GAP ANALYSIS REPORT
UoM
Equipment
Quality assurance
control chart etc
Annex: 4 Soil, plant and water analysis laboratory
Area N
o
Month
1 2 3 4 5 6 7 8 9 1
0

GAP ANALYSIS REPORT
Staffing
laboratory.
17025 requirement.
ISO/IEC 17025
Validation and UoM
Internal auditing
Quality assurance
scope added.
Accommodationand
environmental
condition

GAP ANALYSIS REPORT
nor segregated
Testmethod,Methodvalidationand
UoM
stem and root.
Sampling method
to be tested.
determining UoM.
Equipment
storage, and use.

GAP ANALYSIS REPORT
and authorize use.
its execution
capability.
like
- aspergillus spp
- Fusarium spp
- Bipolaris spp
Sampling/testitem
handling
2 Monitoring the environmental requirements of the
sample storage area.
handling including transportation, receipt,

GAP ANALYSIS REPORT
Documentations
Document control
Record control
Internal audit
Corrective action
Preventive action
documents like
Personnel
UoM
Equipment
Quality assurance

GAP ANALYSIS REPORT
control chart etc

Kulumsa Research Center Labs status report by ptb_afriqual plc

Recommandé

Recommandé

Contenu connexe

Tendances

Tendances (20)

Similaire à Kulumsa Research Center Labs status report by ptb_afriqual plc

Similaire à Kulumsa Research Center Labs status report by ptb_afriqual plc (20)

Plus de Ethiopian Institute of Agricultural Research

Plus de Ethiopian Institute of Agricultural Research (20)

Dernier

Dernier (20)

Kulumsa Research Center Labs status report by ptb_afriqual plc