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FOOD SAFETY ACADEMY OF FOOD SAFETY ASSOCIATES LIMITED

REPORT OF THE TRAINING ON METHOD VALIDATION

AND MEASUREMENT OF UNCERTAINITY

CONDUCTED BY

FOOD SAFETY ACADEMY OF FOOD SAFETY ASSOCIATES LIMITED IN

COLLABORATION WITH THE MINISTRY OF TRADE, INDUSTRY AND

COOPERATIVES UNDER THE QUISP PROJECT

HELD ON 13th

– 16th

AND 26th

-29th

SEPTEMBER 2016 AT UGANDA INDUSTRIAL

RESEARCH INSTITUTE (UIRI)

COMPILED BY

GRACE NANYOMBI- PROJECTS ASSISTANT

FOOD SAFETY ASSOCIATES LTD

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Table of Contents 1.0 INTRODUCTION .................................................................................................................................. 3

2.0 THE OBJECTIVES (OUTPUT AREAS) OF THE ASSIGNMENTOF THE EXPERT ARE; ............. 4

2.1 OUTPUT AREA 6: SUPPORT CAPACITY BUILDING OF TECHNICAL ASSESSORS AND

LABORATORY ANALYSTS IN METHOD VALIDATION AND ESTIMATION OF

MEASUREMENT UNCERTAINTY ........................................................................................................... 4

2.2 The role of MTIC and Food Safety Associates in the achievement of the output/ Preparation of the

trainings ........................................................................................................................................................ 5

2.3 TRAINING ON METHOD VALIDATION AND MEASUREMENT UNCERTAINITIES ................ 6

2.3.1 TARGET PARTICIPANTS OF THE TRAINING .............................................................................. 6

2.3.2 OPENING REMARKS ........................................................................................................................ 7

2.3.3 PRESENTATIONS .............................................................................................................................. 8

2.3.3.1 Day one of the trainings .................................................................................................................... 9

2.3.3.2 Day two of the trainings .................................................................................................................... 9

2.3.3.3 Day three of the trainings ................................................................................................................ 10

2.3.4 AWARD OF CERTIFICATES OF ATTENDANCE ........................................................................ 10

2.3.5 CLOSING REMARKS ...................................................................................................................... 11

2.4 FURTHER ACTION/WHAT IS PENDING ........................................................................................ 11

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1.0 INTRODUCTION

The Government of Uganda through the Ministry of Trade, Industry and Cooperatives (MTIC),

in collaboration with Swedish Government and Trade Mark East Africa (TMEA) has been

implementing the Quality Infrastructure and Standards Programme-QUISP since 2010. The

programme aims at establishing a market-driven, holistic and coordinated institutional

framework for the Ugandan Quality Infrastructure and Standards; which supports trade, industry,

health, safety, consumer protection and a sustainable environment while at the same time

promoting use of best practices in the production and service sectors.

The overall objective of the Quality Infrastructure and Standards Programme (QUISP) is to

promote the use of quality infrastructure and standards so as to improve the competitiveness of

Uganda’s products, processes and service delivery systems in domestic, regional and

international markets.

The programme has five Specific objectives which form the result areas and these include;

1. To develop a policy for Standardization and review strategies for policy implementation

2. To develop a comprehensive and effective legal framework for the implementation and

enforcement of standards and quality control measures.

3. To establish an effective coordination mechanism with clearly defined mandates and

responsibilities for the different actors in the Standards and Quality area

4. To rationalize the institutional set up of service providers for standards development,

conformity assessment and measurement services

5. To enhance public awareness on standards and quality products and best practices

Through the extension implementation of QUISP, the ministry of trade, industry and

cooperatives together with the programme’s technical team developed a number of short term

expert assignments that would require the services of local experts to facilitate the

implementation of those activities. Food Safety Associates Ltd is the local expert that the

Ministry of Trade, Industry and Cooperatives (MTIC) through QUISP to facilitate the

implementation of these Key Short Assignments.

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2.0 THE OBJECTIVES (OUTPUT AREAS) OF THE ASSIGNMENTOF

THE EXPERT ARE;

1. Develop short-term policy studies to guide the decisions of the SMCA fora and other

relevant institutions on topical issues.

2. Develop end of implementation evaluation and phasing out strategy to ensure

sustainability of key QUISP results

3. Support MAAIF, KCCA and UNBS to implement the animal feeds and meat value

related standards and or technical regulation

4. Support training of MDAs in: development of Technical Regulations according to Good

Regulatory Practice (GRP), implementation of control plans and standard operating

procedures, modern monitoring, surveillance and control based on Risk Analysis (i.e.

auditing, certification, sampling and testing).

5. Support the training and implementation of quality standards and best practices for

MSMEs

6. Support capacity building of Technical Assessors and laboratory Analysts in method

validation and estimation of measurement uncertainty.

2.1 OUTPUT AREA 6: SUPPORT CAPACITY BUILDING OF TECHNICAL

ASSESSORS AND LABORATORY ANALYSTS IN METHOD VALIDATION AND

ESTIMATION OF MEASUREMENT UNCERTAINTY

One of the Local Consultant’s roles in this assignment was to support in capacity building of

technical assessors and laboratory analysts in method validation and estimation of Measurement

Uncertainty. This is because it was found out that Capacity Building is required at the Testing

Laboratories as part of the ongoing Quality Infrastructure and Standards Programme (QUISP)

under Ministry of Trade, Industry and Cooperatives to support laboratories for accreditation to

ISO/IEC 17025.

In order for laboratories to be able to get accreditation or designation they should confirm by

examination and provide objective evidences that the testing methods they develop and modify

fulfill particular requirements for a specific intended use. Generally, the assessment of method

validation and estimation of measurement uncertainties is a task of Technical Assessors. In

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addition, the technical management and key laboratory staff are required to be competent to

conduct technical operations and prepare validation reports including eligible data.

Food Safety Associates Ltd through its inception report presented the approach for achieving the

sixth objective/output area of the assignment and below are the specific tasks that the were

proposed and agreed upon;

1. Hands on training on Practical Method Validation of methods

2. Hands on training on estimation of uncertainty in measurements made

3. Train staff on competence evaluation

4. Train staff on basic statistics for Analysts

5. Provide/assist in preparation of Training Materials (Training Protocols, test samples,

relevant analytical reference standards and Quality control materials) sufficient to prepare

the method validation dossier.

6. Give guidance and technical support to have the identified gaps fixed and propose

process and system improvements.

2.2 The role of MTIC and Food Safety Associates in the achievement of the

output/ Preparation of the trainings

Working closely together, MTIC-QUISP focal point personnel and the FSA expert identified the

technical assessors and laboratory analysts who participated in this training. They conducted gap

analysis visits to some of the laboratories in the MTIC’s database, where they clearly understood

the methods used for testing, sample preparation, testing protocols etc that affect method

validation and estimation of uncertainty in measurements. From the visits conducted, the FSA

expert and MTIC QUISP focal point personnel identified and noted down the some of the gaps in

method validation and measurement uncertainty in those laboratories. This gap analysis study

helped the FSA expert to prepare training material that clearly addressed some of the gaps that

were noted during the visits.

The training material that the FSA expert developed comprised of;

1. Presentation on Method Validation (definitions, concepts, method validation parameters)

2. Presentation on Basic statistics in Method Validation

3. Concepts and Definitions and Statistics in Measurement Uncertainty

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4. Approach Based on Validation and Quality Control Data

5. A set of practical examples and exercises on Method Validation and Measurement of

Uncertainty.

2.3 TRAINING ON METHOD VALIDATION AND MEASUREMENT

UNCERTAINITIES

The MTIC-QUISP focal point organized the first training workshop which was conducted at

Uganda Industrial Research Institute (UIRI) from 13th

to 15th

September 2016. This training

comprised of the first batch of technical assessors and lab analysts from the selected laboratories.

The second training which comprised of the second batch of technical assessors and lab analysts

from the same selected laboratories was conducted at the same venue and held on 26th

to 29th

September 2016. These two trainings were facilitated by the FSA expert, Mr. Aziz Mukota from

UNBS.

The aim of these trainings was to;

a) Assessment of method validation

b) Estimation of uncertainties in measurements

c) Giving guidance and Technical Support to have the identified gaps fixed and propose

processes and system improvements.

2.3.1 TARGET PARTICIPANTS OF THE TRAINING

They were two 3-days subsequent trainings that comprised of two groups from the selected

laboratories and institutions with a target of over 30 individuals in each group. The target

participants of the trainings were the technical assessors and laboratory analysts from the

selected laboratories. The laboratories or industries that were selected to send representatives for

the two trainings included;

Uganda Industrial Research Institute (UIRI)

Britania Allied Industries

CAMAT LAB (U) LTD- Engineering Laboratory in Bukoto

Dairy Development Authority (DDA)

UNBS (Chemistry, Microbiology, Material Engineering, Metrology labs)

Chemipher (U) Ltd

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MAAIF- Fisheries Lab

National Drug Authority (NDA)

Directorate of Government Analytical Laboratory (DGAL)

National water and Sewage cooperation.

Beverage companies like Riham, Fizzy Soda, Azam

The category of these technical assessors and lab analysts included microbiologists, lab

technicians, metrologists, material technicians, quality assurance personnel, chemists, lab

analysts, lab engineers, research personnel among others.

2.3.2 OPENING REMARKS

The 3-days training started with registration of the participants from the selected laboratories or

industries. It was officially opened by Mr. Richard Muzafiri, the QUISP-MTIC focal personnel

who thanked participants for responding to the call for the training and for representing their

laboratories. From his opening remarks, Mr. Richard Muzafiri emphasized the aim of this

training which is to prepare and support laboratories for accreditation of ISO/IEC 17025. He then

urged the participants to cooperate with the facilitator and be interactive throughout the training.

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Category of Participants of the MV and MU training

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The FSA Team leader/lead expert for this output, Dr. Ananias Bagumire in his opening remarks

emphasized the need of capacity building in Method Validation and Measurement uncertainty

among the laboratory personnel, one of the requirements to attain accreditation for ISO 17025 to

increase customers’ confidence in the tests and analyses carried out in these laboratories.

2.3.3 PRESENTATIONS

The trainings were facilitated by the technical expert from Food Safety Associates Ltd. The

presentation was categorized into different topics of Method Validation and Measurement

Uncertainties with sections of recaps and intermediate practical examples and exercises that were

used to evaluate the participants’ understandings of the discussed concepts. Below are the topics

that were discussed in the trainings;

6. Presentation on Method Validation (definitions, concepts, method validation parameters)

The Importance of measurement Validation in daily life,

The different concepts and definitions that are used in Measurement Validation.

Principles for making valid analytical measurements.

Requirements of ISO 17025 clause 5.4.5.2

The different parameters of Method Validation

7. Presentation on Basic statistics in Method Validation

The discussion majorly focused on the application of Statistics in Method

validation and the different types and categories of statistics and their application.

The participants were on how to apply some of the statistics types in method

validation by use of practical examples; like calculating the mean, range, medium,

standard deviation, variance, performing a t-test, Cochran test and other tests.

8. Concepts and Definitions and Statistics in Measurement Uncertainty

Importance of Measurement uncertainty to lab analysts and assessors

Different concepts, definitions and principles used in Measurement uncertainty

that the lab analysts and assessors should know.

Different types and sources of errors and uncertainties that are encountered in

Measurement Uncertainty.

Application of basic statistics in Measurement Uncertainty.

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Estimation of Measurement Uncertainty in different labs i.e. microbiology labs,

testing labs

9. Approach Based on Validation and Quality Control Data

10. A set of practical examples and exercises on Method Validation and Measurement of

Uncertainty.

2.3.3.1 Day one of the trainings

On the first day of the training, the facilitator started with highlighting some of the training

expectations from the participants some of which were;

To increase on their knowledge on Method Validation and Measurement Uncertainty

To learn how to establish acceptance criteria in method validation

To improve their knowledge on the practicability of Method Validation and Measurement

Uncertainty in the labs.

He then started the training with discussions on Method Validation. Under Method Validation,

the following was discussed

The Importance of measurement Validation in daily life,

The different concepts and definitions that are used in Measurement Validation.

Principles for making valid analytical measurements.

Requirements of ISO 17025 clause 5.4.5.2

The different parameters of Method Validation

In the afternoon session, the facilitator discussed Basic Statistics in Method Validation where the

discussion majorly focused on the application of Statistics in Method validation and the different

types and categories of statistics and their application. He then guided the participants on how to

apply some of the statistics types in method validation by use of practical examples; like

calculating the mean, range, medium, standard deviation, variance, performing a t-test, Cochran

test and other tests. A set of take-home exercises from what was discussed on the first day was

given to the participants, so as to assess their understanding of the discussed subject.

2.3.3.2 Day two of the trainings

The trainings on the second day started with a recap of what was discussed the previous day

which was satisfactorily done. The facilitator then guided the participants on the take home

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exercise set after which assessed them with a two hour exercise that comprised of structured

questions and calculations which was done in groups of five people.

In the afternoon session, the facilitator introduced the concept of Measurement Uncertainty

which covered the following areas;

Importance of Measurement uncertainty to lab analysts and assessors

Different concepts, definitions and principles used in Measurement uncertainty that the

lab analysts and assessors should know.

Different types and sources of errors and uncertainties that are encountered in

Measurement Uncertainty.

Application of basic statistics in Measurement Uncertainty.

Estimation of Measurement Uncertainty in different labs i.e. microbiology labs, testing

labs

The day’s training was closed with emphasis of application of statistics in Measurement

Uncertainty and how to quantify the different components of Measurement Uncertainty.

2.3.3.3 Day three of the trainings

Day three of the training which was the last day started with a recap of the previous day’s

training where the participants were given an opportunity to discuss was what they had learnt the

previous day. The facilitator then continued with the concepts of Measurement Uncertainty

where he expressed uncertainty in measurement with practical examples.

The trainings ended with evaluation of the participants on what they had been taught for all the

three days. This evaluation comprised of a series of exercises and a written examination.

2.3.4 AWARD OF CERTIFICATES OF ATTENDANCE

It was ascertained that all the participants who had attended each of this three days training had

successfully completed the course and so, they had to be appreciated. The appreciation was

through awarding each of the participants a Certificate of Attendance, which was awarded to

them by the invited guest of honor Mr. Deus Mubangizi, the Manager Testing Department

UNBS on behalf of the Director UIRI.

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2.3.5 CLOSING REMARKS

In each of the training, a representative of the trainees gave a vote of thanks to first of all MTIC

under QUISP for organizing such an informative training, thanked the expert of Food Safety

Associates Ltd who had facilitated the training and as well urged the fellow participants to put in

practice what they had studied while in their laboratories, as it is one way the training will

benefit their institutions.

Also Food Safety Associates Ltd thanked the participants for having been good students for the

three days of the trainings, as well emphasized the need of the participants to put in practice what

they had studied as one way of preparing for accreditation of their laboratories and then tasked

them to keep in mind the follow up visits for hands on guidance in some of the laboratories that

will be selected.

In his closing remarks, the guest of honour Mr. Deus Mubangizi as well thanked MTIC under

QUISP for organizing the training and the experts of Food Safety Associates who facilitated the

training. He pointed out that the training had come in the right time since most of the companies

and laboratories are in the process of seeking for accreditation and implementation of ISO 17025

standard, and thus this training is to help them to prepare for the accreditation process.

He then urged the participants to employ the knowledge they have obtained from the training in

their laboratories i.e. to ensure that all the tests they carry out are validated and have an

acceptable level of certainty, as it is one of the ways they will achieve accreditation.

The trainings then ended with a vote of thanks from Mr. Muzafiri Richard, the MTIC- QUISP

focal personnel to all the individuals who had played part in the trainings.

2.4 FURTHER ACTION/WHAT IS PENDING

Since it was agreed that one of the purposes of this training is to impart skills to the trainees on

competence evaluation and statistics for Laboratory analysts, the FSA expert will visit the

trainees’ labs to guide them in preparation of testing protocols, test samples preparation,

analytical standards and quality control where each trainee will be expected to develop a method

validation dossier with guidance of FSA expert.

The FSA expert is also to support the NAFP in the follow up of the accreditation process for the

UNBS, UFL and DGAL laboratories after the visit to the laboratories for guidance on hands on

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process for method validation, estimation of uncertainty of measurement, analytical statistics and

competence evaluation

On addition, the expert is also to support the NAFP to populate the database of the laboratories

and establish a coordination mechanism to sharing of information and participation in inter

laboratory tests/quality collaborations

Lastly, the expert is to prepare and submit a detailed training report.

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