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 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;


managerial duties.

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;


managerial duties.

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

Sta

ffin

g

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

Acc

om

modat

ion a

nd e

nv

ironm

enta

l co

ndit

ion

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.

Tes

t m

ethod, M

ethod v

alid

atio

n

and U

oM

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.

Equip

men

t 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.

Mea

sure

men

t

trac

eabil

ity

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

Sam

pli

ng /

test

ite

m h

andli

ng

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.

Docu

men

tati

ons

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

Staf

fin

g



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


Acc

om

mo

dat

ion

an

d e

nvi

ron

men

tal c

on

dit

ion



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.






Test

met

ho

d, M

eth

od

val

idat

ion

an

d

Uo

M

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.

Equ

ipm

ent

1 Equipment procedure for safe handling, transport,

storage, and use.





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.

Mea

sure

men

t tr

acea

bili

ty 1 Intermediate checks for measuring equipment Interim check for autoclave, PH meter

2 Reference materials Reference microbes for the tests conducted

like

- aspergillus spp

- Fusarium spp

- Bipolaris spp

Sam

plin

g

/te

st it

em

han

dlin

g

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.

Do

cum

enta

tio

ns



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

Staf

fin

g



laboratory.









17025 requirement.




ISO/IEC 17025

Validation and UoM

Internal auditing

Quality assurance






GAP ANALYSIS REPORT


scope added. A

cco

mm

od

atio

n a

nd

en

viro

nm

enta

l co

nd

itio

n














nor segregated









Test

met

ho

d, M

eth

od

valid

atio

n a

nd

Uo

M


stem and root.

Sampling method





to be tested.




GAP ANALYSIS REPORT



determining UoM.

Eq

uip

men

t

1 Equipment procedure for safe handling, transport,

storage, and use.






and authorize use.


its execution




capability.



Mea

sure

men

t tr

acea

bili



like

- aspergillus spp

- Fusarium spp

- Bipolaris spp

Sam

plin

g

/te

st

item

han

dlin

g 1 Sampling procedure Preparing sampling procedure by employing


GAP ANALYSIS REPORT



2 Monitoring the environmental requirements of the








Do

cum

enta

tio

ns



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


Staf

fin

g 1 An organization structure that could describe the


laboratory.









17025 requirement.




ISO/IEC 17025

Validation and UoM

Internal auditing

Quality assurance





scope added.

Acc

om

mo

dat

ion

an

d

envi

ron

men

tal

con

dit

ion












GAP ANALYSIS REPORT





nor segregated









Test

met

ho

d, M

eth

od

val

idat

ion

an

d

Uo

M


stem and root.

Sampling method





to be tested.




determining UoM.

Equ

ipm

ent 1 Equipment procedure for safe handling, transport,

storage, and use.





GAP ANALYSIS REPORT




and authorize use.


its execution




capability.



Mea

sure

men

t tr

acea

bili



like

- aspergillus spp

- Fusarium spp

- Bipolaris spp

Sam

plin

g /t

est

item

han

dlin

g

1 Sampling procedure Preparing sampling procedure by employing


2 Monitoring the environmental requirements of the








GAP ANALYSIS REPORT



Do

cum

enta

tio

ns



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

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