TRAINING MANUAL
TRAINER
Q uality practices
in basic biomedical research (Qpbr)
Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by
U N I C E F / U N D P / W o r l d B a n k / W H O
Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by U N I C E F / U N D P / W o r l d B a n k / W H O
WHO Library Cataloguing-in-Publication Data
Quality practices in basic biomedical research (QPBR) training manual.
Contents: Quality Practices in Basic Biomedical Research Training Manual for the Trainee – Quality Practices in Basic Biomedical Research Training Manual for the Trainer.
1.Biomedical research - methods. 2.Quality control. 3.Ethics, Research. 4.Manuals. 5.Teaching materials. I.UNDP/
World Bank/WHO Special Programme for Research and Training in Tropical Diseases.
ISBN 978 92 4 159920 7 (NLM classification: W 20.5)
Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2010
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Design: Lisa Schwarb Layout: Sabine de Jonckheere
QUALITY PRACTICES
IN BASIC BIOMEDICAL RESEARCH (QPBR) TRAINING MANUAL
FOR THE TRAINER
A tool for training and promoting
Quality Practices in Basic Biomedical Research (QPBR)
concepts in disease endemic countries
TABLE OF CONTENTS
FOREWORD...1
ABOUT THIS TRAINING MANUAL ...2
ACKNOWLEDGEMENTS ...4
INTRODUCTION ...5
SESSION 1 ...8
1.1 QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH ...8
1.2 WHAT IS QUALITY IN RESEARCH ? ...19
SESSION 2 ...37
2.1 ORGANIZATION ...37
2.2 PHYSICAL RESOURCES ...47
SESSION 3 ...62
3.1 DOCUMENTATION – OVERVIEW ...62
3.2 DOCUMENTATION – PRESCRIPTIVE DOCUMENTATION ...72
3.3 DOCUMENTATION – DESCRIPTIVE DOCUMENTATION: RAW DATA AND RECORDS ...82
3.4 DOCUMENTATION – REPORTS AND STORAGE ...95
iii
SESSION 4 ...108
4.1 SUPERVISION AND QUALITY ASSURANCE ...108
4.2 PUBLISHING PRACTICES ...120
4.3 ETHICAL CONSIDERATIONS ...132
SESSION 5 ...145
5.1 CASE STUDIES ...145
5.1.1 TEST ITEM IN ANIMAL MODEL ...145
5.1.2 RESULTS NOT TO BE REPORTED ...146
5.1.3 UNREPORTED VALUES ...147
5.1.4 TECHNOLOGY TRANSFER ...148
5.1.5 BLOOD SAMPLE LOGISTICS AND HANDLING ...149
5.1.6 MULTISITE MULTI-HEADACHES ...150
5.1.7 SCIENTIFIC PEER REVIEW ...151
5.1.8 PREPARING A POLICY DOCUMENT ...152
5.1.9 INVESTIGATING THE UNEXPECTED ...153
5.1.10 IMPLEMENTATION CASE STUDY ...154
SESSION 6 ...157
6.1 WRAP-UP AND EVALUATION ...157
6.2 ISSUING OF CERTIFICATE AND CLOSURE ...157
1
FOREWORD
A key aim of the Special Programme for Research and Training in Tropical Diseases (TDR) is to empower disease endemic countries (DECs) to develop and lead high quality research activities to internationally recognized standards of quality, and so contribute to TDR’s primary mission of “fostering an effective global research effort on infectious diseases of poverty in which disease endemic countries pay a pivotal role”.
One way we have approached this is to produce guidelines and training manuals that will help institutions and researchers attain the highest international quality standards in their research. In 2006 we published a handbook on Quality Practices in Basic Biomedical Research (QPBR) which received worldwide acceptance and acclaim, from both industry and academia. It also created a demand for training, especially in DECs.
This manual (for trainers), and the accompanying manual (for trainees) will help meet this demand, and will assist institutions in implementing good quality practices. The two manuals, together with the QPBR handbook, now form a sister series to the highly pop- ular series on Good Laboratory Practice (GLP), which has had an impact on the way that laboratory research is carried out in many institutions and countries.
We anticipate that this manual will be useful to all those who aspire to undertaking biomedical research to the best international standards. We believe it will be particularly useful when used with the trainees’ manual in workshops and courses on good quality practices. Used together, the QPBR series will help institutions and researchers ensure that research work is produced, recorded, reported and archived appropriately and in a cost- effective and efficient manner.
Dr Robert Ridley, Director TDR, Special Programme for Research and Training in Tropical Diseases Executed by WHO and co-sponsored by UNICEF, UNDP, the World Bank and WHO
2
ABOUT THIS TRAINING MANUAL
Quality practices in basic biomedical research are of paramount importance when resources are limited and when the results of research are to be used to advance science, shape policies or aid decision making. This applies particularly to disease endemic coun- tries (DECs), although quality practices in research are just as essential for other parts of the world.
Establishing good quality practices in research can only improve the quality of research and the veracity of data derived from it. Guidelines on quality of research also steer researchers towards approaching their work in a similar way, no matter where they are working. This is a critical element in research, allowing experiments to be reproduced more easily and the body of evidence on a particular research issue to grow.
In the absence of national or international guidelines on Quality Practices in Basic Medical Research, in 2006 TDR published at WHO a Handbook on Quality Practices in Basic Biomedical Research (QBPR) to help researchers throughout the world produce high-quality biomedical research. The handbook highlighted non-regulatory practices that can be easily institutionalized at very little extra expense.
The QPBR handbook was so well received and the demand for training so high (especially in DECs) that the decision was made to develop this brand new manual for trainers of QPBR and an accompanying manual for trainees.
The two QPBR training manuals are based on the QPBR handbook and are designed around a course / workshop on QPBR. They therefore outline the goals of the course / work- shop and the topics that should be covered. The manuals include a set of power point slides, questions and case histories on QPBR. The QPBR handbook explains why QPBR is essential and also provides help (through illustrative examples and templates) on how QPBR can be implemented.
3
The training manuals can be used to conduct standardized and validated training; they provide institutions and researchers with the necessary tools for implementing and moni- toring quality practices in their research. Training of trainers will lead to propagation of the number of individuals who can train others about QPBR.
The QPBR series supports TDR’s long-term mission of helping DECs develop their own research activities. Training efforts throughout the world, especially in Asia, Latin America and Africa, will lead to the formation of a global culture of quality practice in research.
This in turn should help institutions in their quest for partnerships with both the public and the private sector. Overall, the adoption of QPBR – facilitated by these training manuals – will have the effect of promoting cost-effective, accelerated research with a long-term positive effect on the development of products for the improvement of human health.
4
ACKNOWLEDGEMENTS
This manual for trainers is part of a suite of three documents produced by WHO / TDR : 1. Quality Practices in Basic Biomedical Research Handbook (orange)
2. Quality Practices in Basic Biomedical Research Training Manual – for the Trainee (turquoise)
3. Quality Practices in Basic Biomedical Research Training Manual – for the Trainer (brown)
Production of the two training manuals was made possible by the enthusiastic support of and contributions from WHO/TDR and the participants in scientific working groups set up under the auspices of WHO/TDR and collaborators.
Our thanks are also extended to those who helped in the production of the Quality Practices in Basic Biomedical Research Handbook, on which the training manuals are based.
Sincere thanks go to Nadya Gawadi and David Long for their role in drafting this manual.
Comments and suggestions on all aspects of these QPBR training manuals are welcome for consideration in future revisions. Please contact :
Dr Deborah Kioy TDR
World Health Organization Avenue Appia 20
Geneva 27 – Switzerland Tel : + 41 22 791 3524 Fax : + 41 22 791 4854 E-mail : kioyd@who.int
5
INTRODUCTION
The quality practices in basic biomedical research (QPBR) training manual is an accom- paniment to a two-day training course on the subject. The course is divided into six sessions – sessions 1, 2 and 3 are structured for the first day and sessions 4, 5 and 6 for the second.
The manual material has been put together to fit the six sessions (see contents page above).
How to use the WHO / TDR material
Course material :
WHO / TDR handbook on QPBR Trainee manual, including :
UÊÃiÌÊvÊ*ÜiÀ*ÌÊ«ÀiÃiÌ>ÌÊÃ`iÃÊ UÊÃÌÊvÊ}>ÃÊvÀÊi>V ÊÃiVÌ
UÊÃiÌÊvʵÕiÃÌÃÊvÀÊ`ÃVÕÃÃÊvÀÊi>V ÊÃiVÌ
UÊÜÀÃ «ÊÃÕ}}iÃÌÃÊvÀÊi>V ÊÃiVÌ
UÊV>ÃiÊÃÌÕ`iÃÊvÀÊ`ÃVÕÃÃÊ>ÌÊÌ iÊi`ÊvÊÌ iÊÌÀ>}ÊVÕÀÃi°
Goals
Each section has a set list of ambitious pedagogical goals – at the end of the course you should be able to formulate the requirements of QBPR in order to transmit and implement them (in dialogue with your respective research institutions). The more lively the discussions and exchanges between you and the other participants during this course, the more you will learn ; so contribute actively to all the workshop sessions and ask questions of the trainer.
The goals are set in a hierarchy from simple to complex cognitive skills : this is because you will be expected to complete an exceedingly complicated exercise (implementation of QPBR) when you return to your research institution. Simple knowledge of QBPR will not be sufficient for this task.
Bloom’s taxonomy of learning domains* is used in the description of goals for each section.
This system is not new but can be used relatively simply to categorize the level of abstraction of tasks that occur in educational settings.
*From Bloom, Benjamin S.Taxonomy of educational objectives. Boston, MA : Allyn and Bacon. Copyright (c) Pearson Educa- tion 1984. Adapted by permission of the publisher. Table copied from University of Victoria web site (http : / / www.coun.
uvic.ca / learning / exams / blooms-taxonomy.html).
6
TRAINER Introduction UÊ+* ,Ê/À>}Ê>Õ>
Competence Skills Demonstrated
Knowledge UÊLÃiÀÛ>ÌÊ>`ÊÀiV>ÊvÊvÀ>ÌÊ UÊÜi`}iÊvÊ`>ÌiÃ]ÊiÛiÌÃ]Ê«>ViÃÊ UÊÜi`}iÊvÊ>ÀÊ`i>ÃÊ
UÊ>ÃÌiÀÞÊvÊÃÕLiVÌÊ>ÌÌiÀÊ
Question Cues :
list, define, tell, describe, identify, show, label, collect, examine, tabulate, quote, name, who, when, where, etc.
Comprehension UÊÕ`iÀÃÌ>`}ÊvÀ>ÌÊ UÊ}À>ëÊi>}Ê
UÊÌÀ>Ã>ÌiÊÜi`}iÊÌÊiÜÊVÌiÝÌÊ UÊÌiÀ«ÀiÌÊv>VÌÃ]ÊV«>Ài]ÊVÌÀ>ÃÌÊ UÊÀ`iÀ]Ê}ÀÕ«]ÊviÀÊV>ÕÃiÃÊ
UÊ«Ài`VÌÊVÃiµÕiViÃÊ
Question Cues :
summarize, describe, interpret, contrast, predict, associate, distinguish, estimate, differentiate, discuss, extend
Application UÊÕÃiÊvÀ>ÌÊ
UÊÕÃiÊiÌ `Ã]ÊVVi«ÌÃ]ÊÌ iÀiÃÊÊiÜÊÃÌÕ>ÌÃÊ UÊÃÛiÊ«ÀLiÃÊÕÃ}ÊÀiµÕÀi`ÊÃÃÊÀÊÜi`}iÊ
Questions Cues :
apply, demonstrate, calculate, complete, illustrate, show, solve, examine, modify, relate, change, classify, experiment, discover
7
Introduction UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Analysis UÊÃii}Ê«>ÌÌiÀÃÊ UÊÀ}>â>ÌÊvÊ«>ÀÌÃÊ
UÊÀiV}ÌÊvÊ ``iÊi>}ÃÊ UÊ`iÌvV>ÌÊvÊV«iÌÃÊ
Question Cues :
analyse, separate, order, explain, connect, classify, arrange, divide, compare, select, explain, infer
Synthesis UÊÕÃiÊ`Ê`i>ÃÊÌÊVÀi>ÌiÊiÜÊiÃÊ UÊ}iiÀ>âiÊvÀÊ}ÛiÊv>VÌÃÊ
UÊÀi>ÌiÊÜi`}iÊvÀÊÃiÛiÀ>Ê>Ài>ÃÊ UÊ«Ài`VÌ]Ê`À>ÜÊVVÕÃÃÊ
Question Cues :
combine, integrate, modify, rearrange, substitute, plan, create, design, invent, what if ? compose, formulate, prepare, generalize, rewrite
Evaluation UÊV«>ÀiÊ>`Ê`ÃVÀ>ÌiÊLiÌÜiiÊ`i>ÃÊ UÊ>ÃÃiÃÃÊÛ>ÕiÊvÊÌ iÀiÃ]Ê«ÀiÃiÌ>ÌÃÊ UÊ>iÊV ViÃÊL>Ãi`ÊÊÀi>Ãi`Ê>À}ÕiÌÊ UÊÛiÀvÞÊÛ>ÕiÊvÊiÛ`iViÊ
UÊÀiV}âiÊÃÕLiVÌÛÌÞÊ
Question Cues :
assess, decide, rank, grade, test, measure, recommend, convince, select, judge, explain, discriminate, support, conclude, compare, summarize
8
SESSION 1
1.1 QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH
Goalssta
At the end of the session, you should be able to :
UÊ `iviÊL>ÃVÊLi`V>ÊÀiÃi>ÀV Ê>`Ê«>ViÊÌÊÊVÌiÝÌÊÜÌ Ê>ÌiÀÊÃÌ>}iÊÀiÃi>ÀV ÊÆ UÊ `iÃVÀLiÊV >}iÃÊÊÌ iÊÃV>Ê>`Ê>ÌÕÀ>ÊiÛÀiÌÊÌ >ÌÊ>ÀiÊ>VViiÀ>Ì}Ê i>Ì Ê
problems today ;
UÊ «ÀiÃiÌÊÌ iÊV>ÃiÊvÀÊ+* ,Ê}Õ`iiÃÊ>ÃÊ>Ê>`ÊÌÊÃiiVÌÊvÊiÜÊ«ÀiVÌÃÊ>`ÊvÀÊ the acceptance of new products / principles ;
UÊ `iÃVÀLiÊ>`ÊiÝi«vÞÊÌ iÊ`vviÀiViÊLiÌÜiiÊÌ iÊÃViÌvVÊVÌiÌÊ>`ÊÌ iÊ«À>VÌV>Ê performance of research studies ;
UÊ ÀiV}âiÊÌ iÊÃÌ>}iÃÊvÊLi`V>ÊÀiÃi>ÀV Ê>`Ê}ÛiÊiÝ>«iÃÊvÀÊiÛiÀÞ`>ÞÊ«À>VÌViÊ or examples that do not fit the model (include drug products, other products and / or principles for new therapies or strategies).
9
Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 1:1:2 Session 1:1:1
10
TRAINER Session 1 UÊ+* ,Ê/À>}Ê>Õ>
Session 1:1:4 Session 1:1:3
11
Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 1:1:6 Session 1:1:5
12
TRAINER Session 1 UÊ+* ,Ê/À>}Ê>Õ>
Session 1:1:8 Session 1:1:7
13
Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 1:1:10 Session 1:1:9
14
TRAINER Session 1 UÊ+* ,Ê/À>}Ê>Õ>
Session 1:1:12 Session 1:1:11
15
Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 1:1:14 Session 1:1:13
16
TRAINER Session 1 UÊ+* ,Ê/À>}Ê>Õ>
Session 1:1:16 Session 1:1:15
17
Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 1:1:17
Questions
UÊ 7 >ÌÊÃÊL>ÃVÊLi`V>ÊÀiÃi>ÀV ʶÊÛiÊ>ÊiÝ>«iÊvÀÊÞÕÀÊÜÊiÝ«iÀiVi°
UÊ 7 >ÌÊÕÀ}iÌÊ i>Ì ÊV >i}iÃÊÃÊÌ iÊÜÀ`Êv>V}ʶÊ>ÊÞÕÊ>``ÊÀiÊiÝ>«iÃʶ
UÊ 7 ÞÊÃÊÌÊ`vvVÕÌÊÌÊ>ÌV ÊÌ iÊii`ÃÊvÀÊ«ÀiÛiÌÊ>`ÊÌÀi>ÌiÌÊÜÌ Ê>ÊÃÕ««ÞÊvÊ new products and / or principles to combat disease and other threats to health ? UÊ 7 ÞÊ>ÀiÊ}Õ`iiÃÊvÀÊL>ÃVÊÀiÃi>ÀV Ê i«vÕÊÊi>L}ÊÌ iÊÃÕ««ÞÊvÊiÜÊ«À`ÕVÌÃÊ
and / or principles to combat disease and other threats to health ?
UÊ iÃVÀLiÊÌ iÊÃV«iÊvÊÌ iÊ+* ,Ê}Õ`iiÃ°Ê iÊëiVvVÊ>LÕÌÊÜ >ÌÊÃÊ>`ÊÜ >ÌÊÃÊÌÊ addressed.
UÊ 7 ÞÊ ÜÕ`Ê }Õ`iiÃÊ v>VÌ>ÌiÊ Ì iÊ `iVÃ>}Ê «ÀViÃÃÊ vÀÊ vÕ`}Ê iÜÊ projects ?
UÊ 7 >ÌÊÃÊvÀ>Õ`ÕiÌÊÀiÃi>ÀV ʶÊ7Õ`ÊÌ iÊÕÃiÊvÊ}Õ`iiÃÊ`ÃVÕÀ>}iÊvÀ>Õ`ÊÊL>ÃVÊ biomedical research ?
UÊ 7 >ÌÊÃÊi>ÌÊLÞÊÀi}Õ>Ìi`ÊÀiÃi>ÀV ʶÊÛiÊiÝ>«iÃÊvÊÃiÊvÊÌ iÊÀi}Õ>ÌÃÊ>`Ê what they cover.
UÊ 7 iÀiÊ`iÃÊ+* ,ÊvÌÊÌÊÌ iÊÃÌ>}iÃÊvÊ`ÀÕ}Ê`iÛi«iÌÊÀiÃi>ÀV ʶ
UÊ 7 >ÌÊ« >ÃiÃÊV«ÀÃiÊL>ÃVÊLi`V>ÊÀiÃi>ÀV ʶ
18
TRAINER Session 1 UÊ+* ,Ê/À>}Ê>Õ>
Workshops
1. Take an example of a research project from your everyday activity and place it in context as a stage in basic biomedical research. What activities preceded it and what will follow ?
What is the aim of this project and what studies are involved ? How will you con- solidate the results for transition to the next stage ? Are all the studies in the project at the same stage of basic research ?
Present your discussion using the flip chart or board for diagrams, flow charts or any other presentation you prefer.
It is impossible to predict what topics the participants will choose. Bear in mind the descriptions in the QPBR handbook (pp. 17-23) and Appendix 2 (pp. 73-74) when listening to their feedback.
Points to cover in discussion
UÊ ÌÊÃÊ«ÀÌ>ÌÊÌ >ÌÊÀiÃi>ÀV iÀÃÊ>ÀiÊ>Ü>ÀiÊvÊÌ iÊÛiÀ>Ê>ÃÊvÊÌ iÊÀiÃi>ÀV Ê project and their participation in it.
UÊ ÌÊ ÃÊ «ÀÌ>ÌÊ Ì >ÌÊ ÀiÃi>ÀV iÀÃÊ ÜÊ Ü iÀiÊ Ì iÀÊ «>ÀÌVÕ>ÀÊ ÃÌÕ`iÃÊ >ÀiÊ
V>Ìi`Ê Ê Ì iÊ ÛiÀ>Ê ÀiÃi>ÀV Ê «ÀiVÌ]Ê °i°Ê Ü >ÌÊ ViÃÊ LivÀiÊ >`Ê Ü >ÌÊ comes after.
UÊ ,iÃi>ÀV Ê«ÀiVÌÃÊ>ÃÌÊViÀÌ>ÞÊ«ÀVii`ÊÊ}V>ÊÃÌi«ÃÊÜÌ ÊÌiÊ«ÌÃÊ at which major decision(s) (GO/NO GO) are taken. It is important that ÀiÃi>ÀV iÀÃÊ>ÀiÊ>Ü>ÀiÊvÊÌ iÃiÊiÃÌiÊiÛiÌÃÊ>`Ê ÜÊÌ iÀÊÜÀÊVÌÀLÕÌiÃÊ to the decisions.
UÊ ÌÊÃÊ«ÀÌ>ÌÊÌ >ÌÊÀiÃi>ÀV iÀÃÊÜÊÜ iÌ iÀÊÀÊÌÊÌ iÀÊÜÀÊÃÊVÛiÀi`Ê LÞÊëiVvVÊÀi}Õ>Ìð
UÊ ÛiÊvÊÊÀi}Õ>ÌÀÞÊÌiÝÌÃÊVÛiÀÊÀiÃi>ÀV iÀýÊëiVvVÊÜÀ]ÊÌ iÀiÊÃÊ>ÊiÛ`iÌÊ
ii`ÊvÀÊ}`ʵÕ>ÌÞÊ`>Ì>Ê>`ÊÃ`]ÊVÀi`LiÊÀiÃÕÌÃÊ>ÃÊÌ ÃÊÜÀÊÜÊV- ÌÀLÕÌiÊÌÊ>ÀÊ`iVÃÃÊ`ÕÀ}ÊÌ iÊ«ÀiVÌ°
19
Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
2. Use a flip chart to draw up a flow chart showing the different research and development stages for a new drug. Indicate the places at which QPBR and regulatory texts impact the development pathway.
ÀÊ>ÊL>ÃVÊ`>}À>ÊvÊÌ iÊÃÌ>}iÃÊvÊ`ÀÕ}Ê`iÛi«iÌÊÃiiÊ+* ,Ê««i`ÝÊÓ]Ê«°ÊÇ{
1.2 WHAT IS QUALITY IN RESEARCH ?
Goals
At the end of the session, you should be able to : UÊ `iviʺʵÕ>ÌÞÊ»ÊÊ}iiÀ>ÊÌiÀÃÊÆ
UÊ iÝ«>Ê Ì iÊ `vviÀiViÊ LiÌÜiiÊ Ì iÊ ÃViÌvVÊ VÌiÌÊ >`Ê Ì iÊ «À>VÌV>]Ê À}>â>- tional aspects of experimental science ;
UÊ `iviÊÌ iÊ«ÕÀ«ÃiÊvÊ+* ,ÊÊÌiÀÃÊvÊ`>Ì>ÊÀi>LÌÞÊ>`Ê>``i`ÊÛ>ÕiÊÆ
UÊ ÃÌÊÌ iʵÕ>ÌÞÊ>ÌÌÀLÕÌiÃÊvÊL>ÃVÊLi`V>ÊÀiÃi>ÀV Ê>`ÊÕÌiÊÌ iÀÊi>}ÃÊÆ UÊ `iÃVÀLiÊÌ iÊÃÀÌÊvÊ>VÌÛÌÞÊÌ >ÌÊÌ iÊÃViÌvVÊVÕÌÞÊÕÃiÃÊÌÊÛ>`>ÌiÊÃÌÕ`iÃÊ>`Ê
data ;
UÊ ÕÌiÊ>ÊÃiÌÊvÊÛ>À>LiÃÊ>vviVÌ}Ê>ÊÃÌÕ`Þ]Ê«ÃÃLÞÊÌÀ`ÕV}ÊL>ÃÊÆ
UÊ >À}ÕiÊvÀÊÌ iÊ«ÀÌ>ViÊvÊV>ÀivÕÊ«>}Ê>`Ê>ÊÜÀÌÌiÊ«>ÊvÀÊi>V ÊÃÌÕ`ÞÊÆ UÊ ÃÕ>ÀâiÊÌ iÊV>ÃiÊvÀÊÕÃ}ÊÃÌ>`>À`Ê«ÀVi`ÕÀiÃÊvÀÊÀÕÌiÊ>VÌÛÌiÃÊÆ
UÊ iÝ«>Ê Ü ÞÊ >Ê >i`Ê `Û`Õ>Ê ii`ÃÊ ÌÊ Ì>iÊ } iÛiÊ ÀiëÃLÌÞÊ vÀÊ Ì iÊ design and conduct of a study ;
UÊ iÝ«>ÊÌ iÊ«ÕÀ«ÃiÊvÊVÌÀÃÊÆ
UÊ >ÃÃiÃÃÊVÀÌV>ÞÊ ÜÊÛ>À>LiÃÊvÕiViÊÃÌÕ`ÞÊÀiÃÕÌÃÊÆ UÊ `iÃVÀLiÊÌ iÊÀi>Ìà «ÊLiÌÜiiÊ«>]ÊÃÌÕ`ÞÊ>`Ê`>Ì>ÊÆ
UÊ `iÃVÀLiÊ >Ê ÀiÃi>ÀV iÀ½ÃÊ ii`ÃÊ vÀÊ Ài«iÌÌÊ vÊ >Ê ÃÌÕ`Þ]Ê i°}°Ê Ê ÌiÀÃÊ vÊ `>Ì>Ê >`Ê documents.
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Questions
ÊUÊ 7 >ÌÊ>ÀiÊÌ iÊÌÜÊ>ëiVÌÃÊvÊÀiÃi>ÀV ʵÕ>ÌÞʶÊ7 >ÌÊ`iÃÊi>V Ê>ëiVÌÊVÌÀLÕÌiÊÌÊ the total quality ?
ÊUÊ 7 >ÌÊÃÊÌ iÊ«ÕÀ«ÃiÊvÊ+* ,ʶÊ
ÊUÊ ÃÊÌ iÀiÊ>Ê«À>VÌV>Ê>`Û>Ì>}iÊÌÊ>}ÊÃÕÀiÊÌ >ÌÊÞÕÀÊÀiÃi>ÀV ÊÜÀÊÃÊÜiÀ}>âi`ʶ
ÊUÊ 7 >ÌÊÛ>ÕiÊ`iÃÊÜiÀ}>âi`ÊÀiÃi>ÀV Ê `ÊvÀÊÌ iÀÊÀiÃi>ÀV iÀÃʶ
ÊUÊ 7 >ÌÊÃÊÌ iÊ`ivÌÊvʺʵÕ>ÌÞÊ»ÊÊ+* ,ʶÊÊÞÕÊ>}ÀiiʶÊÀiÊÌ iÀiÊÌ iÀÊi>}ÃÊ¶Ê ÊUÊ 7 >ÌÊ>ÀiÊÌ iʵÕ>ÌÞÊV >À>VÌiÀÃÌVÃÊvÊÃViÌvVÊÀiÃi>ÀV ʶ
ÊUÊ >ÊÞÕÊLÀivÞÊ`iviÊi>V Êiʶ
ÊUÊ 7 >ÌÊ>ÀiÊiÝ«iÀiÌ>ÊÛ>À>LiÃʶÊ
ÊUÊ 7 >ÌÊÃÊÌ iÊiÃÃ>}iÊvÊÌ iÊÌÜÊiÝ>«iÃÊ}Ûiʶ
ÊUÊ 7 ÞÊà Õ`ÊÞÕÊëi`ÊÌiÊÊ>ÊÜÀÌÌiÊ«>ʶ
ÊUÊ 7 >ÌÊÃÀÌÊvÊvÀ>ÌÊÜÕ`ÊÞÕÊVÕ`iÊÌÊ`iÃVÀLiÊÉÊVÌÀÊÛ>À>LiÃʶÊÛiÊÌÜÊ or three examples.
ÊUÊ ÜÊ`iÃÊÌ iÊvÀ>ÌÊÊÌ iÊÃÌÕ`ÞÊ«>Ê`vviÀÊvÀÊÌ iÊvÀ>ÌÊÊÌ iÊ`>Ì>Ê¶Ê ÊUÊ Ý«>ÊÌ iÊÌi`i`ÊÃV«iÊvÊ+* ,]ÊVÕ`}ÊÜ >ÌÊÃÊÌÊVÛiÀi`°
Workshops
1. List the quality attributes of two or three everyday products or services (e.g. a drinking cup, cup of coffee, road, weather forecast, organizing a holiday). Could different examples of the same sort of product have different quality attributes ? List your examples and their quality attributes on the flip chart.
DISCUSSION
ºÊ+Õ>ÌÞÊÃÊÌ iÊÌÌ>ÌÞÊvÊV >À>VÌiÀÃÌVÃÊvÊ>ÊiÌÌÞ°°°ÊÌ >ÌÊLi>ÀÊÊÌÃÊ>LÌÞÊ ÌÊÃ>ÌÃvÞÊÃÌ>Ìi`Ê>`Ê«i`Êii`ÃÊ»Ê+* ,Ê >`L]Ê«°ÓÈ®°Ê/ iÊ>ÊÃÊÌÊ
`iÃÌÀ>ÌiÊÌ >ÌÊvʵÕ>ÌÞÊrÊ«À`ÕVÌÊÉÊÃiÀÛViÊvÌÊvÀÊii`ÊÉÊÕÃiÊÌ iÊvÀ>-
âi`ÊiÌ `ÃÊÜÊ«À`ÕViÊ>Ê«À`ÕVÌÊÌ >ÌÊÃÊvÌÊvÀÊÕÃiÊiÛiÀÞÊÌi°Ê ÌiÊÌ >ÌÊ Ì iÊÃÌ>Ìi`Êii`ÊÉÊÕÃiÊ`ÀÛiÃÊÌ iÊV ViÊvÊ>ÌÌÀLÕÌiÃÊ>`ÊÌ >Ìʺ } µÕ>ÌÞÊ»Ê V>ÌÊ LiÊ`ivi`Ê>ÃÊ>Ê«Ài`iÌiÀi`ÊÃiÌÊvÊ>ÌÌÀLÕÌiðÊ/ iÊÃÌÀÕVÌÕÀiÊvÊÌ iÊ
>À}ÕiÌÊÃÊÌ iÊÃ>iÊvÀÊ>ÊiÝ>«ið
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Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
£°Ê ÌÊÃÊiÃÃiÌ>ÊÌÊ`iviÊÌ iÊ«À`ÕVÌÊÉÊÃiÀÛViÊVi>ÀÞ]ÊVÕ`}ÊÌÃÊÕÃi°
Ó°Ê ÃÌÊÌ iÊVÀÌiÀ>ÊvÀÊÃÕVViÃÃÊqÊÌ iʵÕ>ÌÞÊ>ÌÌÀLÕÌið
Î°Ê >iÊ>ÊvÀÃÌÊÃiÌV Ê«ÃÃLÞÊ>Ê`Ê>«ÊÀÊvà LiÊ`>}À>®ÊvÊÌ iÊ«À>VÌV>Ê ÃÌi«ÃÊÌÊiÃÕÀiÊÌ >ÌÊÌ iÊÀ} ÌÊ«À`ÕVÌÊvÊÌ iÊÀ} ÌʵÕ>ÌÞÊÃÊLÌ>i`°
First example : a drinking cup
*À`ÕVÌÊ\Ê>Ê`À}ÊVÕ«
ivÌÊ\ÊÀiVi«Ì>ViÊvÀÊ\
UÊ `}Ê«Ì>LiʵÕ`ÃÊ>`ÊÌÀ>ëÀÌ}ÊÌ iÊÌÊÞÕÀÊÕÌ Ê
UÊ ÕÃiÊÊÞÕÀÊiÛiÀÞ`>ÞÊ ÕÃi `ÊÉÊ>ÌÊÌ iÊÛ>}iÊ}>À`iÊ«>ÀÌÞÊÉÊ>ÌÊÌ iÊ+Õii½ÃÊ }>À`iÊ«>ÀÌÞÊÉÊV>«}ÊÊÓÊÉÊ>ÌÊÌ iÊV>Ê«À>ÀÞÊÃV °
Attributes
UÊ ÊÌÊ>ÊVÕ«ÃÊ\ÊÀ}`ÊiÕ} ÊÌÊ `ʵÕ`ÊÜÌ ÕÌÊëÊÆÊ `ÃÊ ÌÊÀÊ V`ʵÕ`ÊÆÊ`iÃÊÌÊLÕÀÊÞÕÀÊ >`ÊÆÊÀÊÕÃÌÊÌÊLiViÊÌÊ ÌÊÆÊÃÌ ÊÀ°Ê UÊ ÕÀÌ iÀÊ>ÌÌÀLÕÌiÃÊ`i«i`ÊÊÌ iÊÕÌ>ÌiÊÀiµÕÀi`ÊÕÃiÊvÊÌ iÊVÕ«ÊÊ\Ê`iÃÌÀÕVÌLiÊ
Ê>Êv>ÊÆÊVÀÜ>Ûi>LiÊÆÊ`ëÃ>LiÊÆÊÌÀ>ÃÕViÌÊ«ÀVi>ÊÆÊ}`Êi>i°Ê UÊ *>ÀÌV«>ÌÃÊÕÃÌÊÕ`iÀÃÌ>`ÊÌ >ÌÊÌ iÊ«>«iÀÊVÕ«Ê>`ÊÌ iÊÌÀ>ÃÕViÌÊ«ÀVi>Ê
>ÀiÊLÌ Ê«ÌiÌ>ÞÊ } µÕ>ÌÞÊ«À`ÕVÌð
>Û}ÊV ÃiÊ" ÊÃiÌÊvÊ>ÌÌÀLÕÌiÃÊÊÌ iÀÊ`ÃVÕÃÃÃ]Ê«>ÀÌV«>ÌÃÊà Õ`Ê V«ÃiÊ >Ê `Ê >«Ê ÀÊ và LiÊ `>}À>Ê ÕÌ}Ê Ì iÊ µÕ>ÌÞÊ ÃÞÃÌiÊ ÀiµÕÀi`Ê ÌÊ >V iÛiÊ Ì iÃi°Ê / iÊ µÕ>ÌÞÊ ÃÞÃÌiÊ Ã Õ`Ê VÛiÀÊ\Ê `iÃ}]Ê À>ÜÊ
>ÌiÀ>Ã]Ê «À`ÕVÌÊ iµÕ«iÌ]Ê >Õv>VÌÕÀ}Ê «ÀViÃÃiÃ]Ê «iÀÃi]Ê ÌÀ>}]ÊÃÌÀÕVÌÃÊiÌV°Ê
Second example : a cup of coffee
*À`ÕVÌÊ\Ê>ÊVÕ«ÊvÊ«Ì>LiÊVvviiÊ Attributes
Ê Ê>ÌÌÀLÕÌiÃÊ\Ê ÌÊÆÊvÀ>}À>ÌÊÆÊÌ>ÃÌiÃÊ}`ÊÆÊÃÌÕ>Ì}ÊÆÊÌiÞ°Ê
Ê ÀiÊ Ã«iV>âi`Ê >ÌÌÀLÕÌiÃÊ vÕiViÊ Ì iÊ µÕ>ÌÞÊ ÃÞÃÌiÊ vÀÊ «À`ÕVÌÊ\Ê Ã«iÊÌÊ>iÊÆÊ`iV>vvi>Ìi`ÊÀÊV>vvi>Ìi`ÊÆÊvÀÕÌÞÊÀÊLÌÌiÀÊÌ>ÃÌiÊÆÊÜ Ìii`ÊÆÊ
iÊVÕ«ÊÀÊ>À}iÊ>ÕÌÊvÀÊ«>ÀÌÞÊÆÊ`ÀÊÜÊÀÊii«Ê Ì°
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>Û}ÊV ÃiÊ" ÊÃiÌÊvÊ>ÌÌÀLÕÌiÃ]Ê>ÃÊ«>ÀÌV«>ÌÃÊÌÊV«ÃiÊ>Ê`Ê>«Ê
ÀÊvà LiÊ`>}À>ÊÜÌ ÊÌ iÊ i>`iÃÊvÀÊ«À`ÕVÌÊ«ÀViÃÃiÃ°Ê ° °Ê -Ê" 9ÊqÊÌ iÀiÊÃÊ>Ì iÀÊiÝiÀVÃiÊÊVvviiÊÊÌ iÊÜÀà «Ê>LÕÌÊ-"*ðÊ
Third example : a road
*À`ÕVÌÊ\ÊÊ>ÊÀ>`
ivÌÊÊ\Êi}>Ìi`Ê«iViÊvÊ>`ÊÌ >ÌÊi>`ÃÊ>Ê«iÀÃÊvÀÊ«>ViÊÊÌÊ«>ViÊ Attributes
UÊ Common attributes :ÊÃÌ>ÀÌÊ>ÌÊÊ>`Êi`Ê>ÌÊ ]Ê«iÀÃÊÉÊ}`ÃÊÃÌÊÌ>VÌ]ÊÊ>Ê ÀÕ} ÞÊ`ivi`ÊÌi°
UÊ More specialized attributes :ÊvÀÊVÌÞÊÌÊVÌÞÊÆÊvÀÊÌÀ>ëÀÌ}Ê}`ÃÊÆÊ
i>`ÊÌÊLÀ`ÊÃ>VÌÕ>ÀiÃÊÆÊÕ«Ê>`Ê`ÜÊÕÌ>ðÊÌÌÀLÕÌiÃÊ\ÊÃÌ ÊÃÕÀ- v>ViÊÆÊ >À`ÊÃÕÀv>ViÊÆÊ`À>i`ÊÆÊii«ÊLiVÌÛiÊÊÛiÜÊLÞÊÕÃiÊvÊÃ}ÃÊÀÊ>VÊ
vÊVvÕÃ}ÊÃ`iÀ>`ðÊ
UÊ Specialized attributes :ÊVÕÀi`Ê>ë >ÌÊÆÊL>ÀÀiÀÃÊÌÊv>ÃÌÊÌÀ>vvVÊÆÊ}À>ÃÃÊÊVi- ÌÀ>ÊÀiÃiÀÛ>ÌÊÆÊÃiÊL>ÀÀiÀÃÊÆÊÜ`Ê«ÀÌiVÌÊÆÊ >À«ÊÌÕÀÃÊÌÊ>VV-
`>ÌiÊ}À>`iÌÊÆÊÌ>ÀÞÊ}Õ>À`Ã]ÊiÌV°Ê`i«i`}ÊÊ«À«Ãi`ÊÕÃi°
*>ÀÌV«>ÌÃÊÃ Õ`ÊVÃÌÀÕVÌÊ i>`iÊ`Ê>«]Ê>ÃÊLivÀi°Ê}>]Ê`v- viÀiÌÊÌÞ«iÃÊvÊÀ>`ÃÊV>ÊLiÊ } µÕ>ÌÞÊ`i«i`}ÊÊÌ iÊ`ivÌÊvÊÌ iÊ
«À`ÕVÌ°
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Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Fourth example : a weather forecast
*À`ÕVÌÊ\Ê>ÊÜi>Ì iÀÊvÀiV>ÃÌ
ivÌÊ\Ê>Ê«Ài`VÌÊ>LÕÌÊÌ iÊÜi>Ì iÀÊÌ >ÌÊ>ÜÃÊ>Ê«iÀÃÊÌÊ>iÊ>Ê
>VVÕÀ>ÌiÊ«>ÊvÀÊÃÕVViÃÃvÕÊÉÊÃÕÌ>LiÊ>VÌÛÌiÃ]Ê>««À«À>ÌiÊVÌ }]ÊÌÀ>ëÀÌÊ Attributes
UÊ ÛiÌÃÊ>ÀiÊVi>ÀÞÊ`iÃVÀLi`ÊÜÌ ÊÀi}>À`ÊÌÊÌÞ«i]ÊÃiÛiÀÌÞ]ÊÌiÊvÊÃiÌ]ÊÌiÊ ÌÊV >}i]ÊiÝ>VÌÊ>Ài>ÃÊÌÊLiÊ>vviVÌi`]Ê>ÞÊëiV>Ê`>}iÀÊÜ>À}ðÊ
UÊ >ÃÞÊ `ivi`Ê LÞÊ L>`Ê µÕ>ÌÞ]Ê >VVÕÀ>ÌiÊ >VVÕÌÊ vÊ iÛiÌÃ]Ê ÌÌi`Ê ÃÌÀÊ Ü>À}Ã]ÊVÀÀiVÌÊÌ}]Ê>VVÕÀ>ÌiÊV >ÀÌ}ÊvÊÀi}ðÊ
*>ÀÌV«>ÌÃÊÃ Õ`ÊVÃÌÀÕVÌÊ i>`iÊ`Ê>«]Ê>ÃÊLivÀi°Ê Final example : organizing a holiday
*À`ÕVÌÊ\Ê `>Þ
ivÌÊ\Ê >Ê «iÀ`Ê vÊ ÌiÊ Ìi`i`Ê ÌÊ «ÀÛ`iÊ ÀiÃÌÊ vÀÊ >Ê «iÀýÃÊ `>ÞÊ ÀÕÌiÃ]ÊÀiÌÕÀ}ÊÌ>VÌÊ>`ÊÊÌiÊÌÊÀiÃÕiÊÀ>Ê`ÕÌiÃ
Attributes could be classified as follows : UÊ ÃÕvvViÌÊÌiÊ«iÀ`ÊÌÊ«ÀÛ`iÊÀiÃÌÊvÀÊ`ÕÌià UÊ ÃÕvvViÌÊÌiÀiÃÌÊÌÊ«ÀÌiVÌÊvÀÊLÀi`
UÊ VvVÌÊâi`
UÊ ÃÕvvViÌÊÃ>viÌÞÊÌÊÀiÌÕÀÊÃÌ i>Ì ÞÊ«iÀÃÊÌÊ`ÕÌiÃÊ UÊ ÌiÞÊÀiÌÕÀ
There will be different personal opinions on every attribute : UÊ ÌiÊ\ÊiÊÜiii`]ÊiÊÜii]ÊÌ ÀiiÊÜiiÃ]ÊÌ ÀiiÊÌ ÃÊÆÊ
UÊ ÌiÀiÃÌÊ\Ê `ivÞ}Ê `i>Ì Ê Ê ÓÊÆÊ ÃÕL>Ì }Ê Ê L>VÊ }>À`iÊÆÊ «>Þ}Ê ÃÌÀ}Ê µÕ>ÀÌiÌÃÊÆÊÛÃÌ}ÊVÕÌÕÀ>ÊÃÌiÃÊÆÊÃÌ>Þ}ÊÜÌ Ê/LiÌ>ÊÃÊÆÊÃ>«}Ê`v- viÀiÌÊVÕÃiÃÊiÌVÊÆ
UÊ VvVÌÊ\Ê>ÞÊ>ÀÃiÊvÀÊÌ iÊÌiÀiÃÌÃÊvÊÌ iÊ}ÀÕ«Ê>`ÊÉÊÀÊÌ iÊ}ÀÕ«ÊÉÊv>ÞÊ ÃÌÀÕVÌÕÀiÊÆ
UÊ Ã>viÌÞÊ\Ê«Ài«>Ài`ÊÌÊÀÃÊLi}ÊÌ>iÊ ÃÌ>}i]ÊLLi`]ÊiÝ«Ãi`ÊÌÊ i>Ì Ê >â>À`ÃÊ
ÀÊÃivvVÌi`Ê >ÀÊi°}°Êv>}ÊÕÌÊvÊ>Ê >}Ê}`iÀ®Æ UÊ ÌiÞÊÀiÌÕÀÊ\ÊÃÊÌ ÃÊVÀÌV>ʶÊ7 >ÌÊÃÊÌ iÊÌiÀ>ViʶÊ7 ÞʶÊ
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Having decided on the exact attributes then the proper plan can begin, taking regard of :
UÊ ÌiÊvÊÞi>ÀÊ\ÊÃi>ÃÊÉÊÌi«iÀ>ÌÕÀiÊÉÊÃV Ê `>ÞÃÊÆÊ UÊ V>ÌÞÊ\ÊVÕÌÀÞÊÉÊ>}Õ>}iÊÉÊÌÀ>`ÌÃÊÉÊVÕÃiÊÆÊ
UÊ ÌÕÀÃÌÊ >ÌÌÀ>VÌÃÊ\Ê Ãi>Ê EÊ Li>V ÊÉÊÕÌ>ÃÊÉÊVÕÌÀÞÃ`iÊÉÊÕiÌÃÊÉÊ>ÀÌÊÉÊ vÀiÊÆ
UÊ V«ÃÌÊvÊ«>ÀÌÞÊÆ UÊ ÌÀ>ÛiÊ\Ê`ÕÀ>ÌÊÉÊv>ÀiÊÆ
UÊ ÌiÊ\Ê«ÀViÊÉʵÕ>ÌÞÊÉÊë>ViÊÉÊv>VÌið
2. List the quality attributes for basic biomedical research. Is this an exhaustive list ? Write down what each attribute means in practical, behavioural terms.
DISCUSSION
*À`ÕVÌÊ`ivÌÊÃʺÊÀiÃi>ÀV ÊÀiÃÕÌÃÊÌ >ÌÊ>ÀiÊÃ`ÊiÕ} ÊÌÊi>LiÊ`iÛi-
«iÌÊvÊÕÃivÕÊ«À`ÕVÌÃÊ>`Ê«ÀV«iÃÊvÀÊv} Ì}Ê`Ãi>ÃiÊ»Ê+* ,Ê>Õ>Ê
«°ÓÈ®°Ê ÌiÊÌ iÊ`ivÌÊÃÊÀÌi`ÊÊ«À>VÌV>ÌÞÊqÊÌ iÊÜÀ`Êii`ÃÊ i«ÊÌÊ v} ÌÊ`Ãi>Ãi°Ê/ ÃÊ`ivÌÊiÃÕÀiÃÊÌ >ÌÊ«i«iÊ>ÞÊVv`iÌÞÊÛiÃÌÊÌiÊ
>`Ê ÀiÃÕÀViÃÊ Ê >VÌÛÌiÃÊ L>Ãi`Ê Ê Ì iÊ ÀiÃi>ÀV Ê ÀiÃÕÌÃ°Ê ÌÊ ÃÊ Ì iÊ Ì iÊ ÀiÃi>ÀV iÀ½ÃÊ«ÀviÃÃ>Ê`ÕÌÞÊÌÊLÌ>ÊVÀi`LiÊÀiÃÕÌð
Attributes :
UÊ ÀiiÛ>ÌÊvVÕÃi`ÊÊ i>Ì ÊÃiVÌÀ]Ê«ÀiÛiÌ]ÊVÕÀi]ÊÀÌÊV>ÕÃiÃ]Ê«ÀV«iîÊÆ UÊ Ài>LiÊ>`ÊÀi«À`ÕVLiÊVÕ`ÊLÌ>ÊÃ>ÀÊÀiÃÕÌÃÊÊÃ>ÀÊÃiÌÌ}®ÊÆ UÊ iÌ V>Ê`iÃÊÌÊ`>>}iÊ«i«i]Ê>>Ã]ÊiÛÀiÌ®ÊÆ
UÊ >Õ`Ì>LiÊ>ÞiÊVÕ`ÊÀiÛiÜÊÀiVÀ`Ã]Ê`>Ì>ÊÀÊÀi«ÀÌÃÊ>`ÊÛÕV ÊvÀÊ«ÀiÃiViÊ
>`Ê>ÕÌ iÌVÌÞÊvÊvÀ>ÌÊÌ iÀi®ÊÆ
UÊ ÊÌ iÊ«ÕLVÊ`>Ê>Û>>LiÊvÀÊÕÃi]ÊVÀÌV>ÊÀiÛiÜÊÉÊ>VV>ÊÊ«ÕLà i`Ê form).
-iÊ vÊ Ì iÊ +* ,Ê >ÌÌÀLÕÌiÃÊ >ÀiÊ }ÛiÊ >ÃÊ >Ê và LiÊ `>}À>°Ê / ÃÊ ÃÊ ÌÊ
`iÌ>i`Ê>`ÊÊ`ÕLÌÊ«>ÀÌV«>ÌÃÊÜÊ`iÛi«ÊÌ iÀÊÛ>`Ê>««À>V ið
35
Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
3. Taking one or two studies from your everyday experience write a list of possible sources of bias and discuss measures you could take to minimize artefact to ensure the validity of your data. Present your discussion schematically on the flip chart / board.
DISCUSSION
UÊ >ÃÊ`ÕÀ}ÊiÝ«iÀiÌÃÊi>`ÃÊÌÊÕÀi>LiÊÀÊÕÌÀ} ÌÊv>ÃiÊ`>Ì>°
UÊ ÊÌÕÀ]ÊÌ iÃiÊ`>Ì>Êi>`ÊÌ iÊÀiÃi>ÀV iÀÊÌÊÜÀ}ÊVVÕÃðÊ7iÊvÌiÊëi>Ê
vÊv>ÃiÊi}>ÌÛiÊ>`Êv>ÃiÊ«ÃÌÛiÊÀiÃÕÌð
UÊ >ÃÊV>ÊLiÊÌÀ`ÕVi`ÊvÀÊ>ÞÊÃÕÀViÃ]ÊVÕ`}Ê\
ÊÊ ÀiÃi>ÀV iÀÊ qÊ ÕÌViÊ vÊ iÝ«iÀiÌÊ ÃÊ L>Ãi`Ê ÌÜ>À`ÃÊ Ì iÊ ÀiÃÕÌÊ iÝ«iVÌi`ÊLÞÊÌ iÊÀiÃi>ÀV iÀÊÆ
ÊÊ Ã>«iÃÊÃiiVÌi`ÊqÊi°}°ÊVÃ}}Ê>Ê i>ÛÞÊ>>ÃÊÌÊiÊÃÌÕ`ÞÊ}ÀÕ«Ê
ÀÊ«>V}Ê>ÊÃiÀÃÊÊ}ÀÕ«ÊÌÀi>Ìi`ÊÜÌ Ê«>ViLÊÆ
ÊÊ iÛÀiÌ>Ê v>VÌÀÃÊ `ÕÀ}Ê >Ê ÃÌÕ`ÞÊ qÊ i°}°Ê ViVÌ}Ê ÃiVÌÃÊ `ÕÀ}Ê
«iÀ`ÃÊvÊÜ`ÞÊÜi>Ì iÀÊÊiÊ«>ViÊ>`ÊV>ÊÜi>Ì iÀÊÊ>Ì iÀÊÀÊ
«>V}ÊV>}i`Ê>>ÃÊÊÀ>VÃÊÊ}ÀÕ«ÊÀ`iÀÊÃÊÌ >ÌÊ}ÀÕ«ÃÊÊÌ iÊ
ÜiÀÊiÛiÊ}iÌÊiÃÃÊ} ÌÊÆ
ÊÊ ÀiÃÕÌÊiÛ>Õ>ÌÊÃÌ>}iÊvÊ>ÊÃÌÕ`ÞÊqÊi°}°ÊÀiiVÌÊvÊ`>Ì>ÊÊ>ÀLÌÀ>ÀÞÊ }ÀÕ`ÃÊÀ>Ì iÀÊÌ >Ê«ÀiÛÕÃÞÊ>}Àii`ÊVÀÌiÀ>ÊÆ
ÊÊ Ài«ÀÌ}ÊÃÌ>}iÊvÊ>ÊÃÌÕ`ÞÊqÊi°}°ÊÌÊÀi«ÀÌ}ÊÀiÃÕÌÃÊÌ >ÌÊ>ÀiʺÊÕ- ÌiÀiÃÌ}Ê»ÊÕÃÕ>ÞÊi}>ÌÛi®ÊÀÊ>}>ÃÌÊÀiÃi>ÀV iÀ½ÃÊiÝ«iVÌ>ÌðÊ
36
TRAINER Session 1 UÊ+* ,Ê/À>}Ê>Õ>
UÊ ÌÊ>ÞÊLiÊ`vvVÕÌÊÌÊÛiÀViÊL>ðÊÀÃÌ]ÊÌÊÃÊ«ÀÌ>ÌÊÌÊLiÊ>ÃÊ>Ü>ÀiÊ>ÃÊ
«ÃÃLiÊvÊ>ÊÌ iÊ`vviÀiÌÊÌÞ«iÃÊvÊL>ÃÊÌ >ÌÊVÕ`Ê>vviVÌÊÌ iÊÀiÃi>ÀV °Ê ivÀiÊ
«iÀvÀ}Ê>ÊiÝ«iÀiÌÊÀiÃi>ÀV iÀÃÊà Õ`ÊÕÃiÊ>ÊLÀ>ÃÌÀ}ÊÃiÃÃÊÌÊ
`iÌvÞÊ «ÃÃLiÊ Ü>ÞÃÊ Ì >ÌÊ L>ÃÊ ÃÊ ÌÀ`ÕVi`°Ê / iÊ ÃÌÕ`ÞÊ «ÀÌVÊ Ã Õ`Ê
««ÌÊÌ iÃiÊ`vvVÕÌiÃÊ>`Ê>ÌÌi«ÌÊÌÊÌÊÌ i°Ê6>À>LiÃÊ>`ÊL>ÃÊV>Ê LiÊÀi`ÕVi`ÊLÞÊÃÌ>`>À`â}Ê«ÀVi`ÕÀiÃÊi°}°ÊÕÃ}Ê-"*îÊ>`ÊiÃÕÀ}ÊÌ >ÌÊ Ì iÞÊ >ÀiÊ «iÀvÀ}Ê Ê Ì iÊ Ã>iÊ Ü>Þ°Ê *iiÀÊ ÀiÛiÜÊ i«ÃÊ ÌÊ ÛiÀViÊ Ì iÊ iÝ«iÀiÌiÀ½ÃÊÜÊL>ðÊ
4. Give an example of doubtful scientific results in your everyday activity or from the scientific literature. Was the failure due to scientific problems ? Problems with experimental conduct / data ? A mixture of both ? Or something quite different ? Use the flip chart to summarize your discussion as a table showing the type of failure and the actual circumstances.
9ÕÊ>ÞÊÜà ÊÌÊÀiviÀÊL>VÊÌÊÃ`iÃÊ££Ê>`Ê£ÓÊvÊÌ ÃÊÃiVÌÊÌÊà ÜÊÌÜÊ iÝ>«iÃÊvÊÛ>À>LiÃÊÌ >ÌÊÌÀ`ÕViÊiÝ«iÀiÌ>ÊL>ÃÊ>`Ê`iÃÌÀ>ÌiÊÌ iÊ
ii`ÊvÀÊÜiVÌÀi`ÊÃÌÕ`iÃÊÜÌ ÊÃÌ>`>À`âi`Ê«ÀVi`ÕÀið
37
SESSION 2
2.1 ORGANIZATION
Goals
At the end of the session, you should be able to : UÊ iÝ«>ÊÜ ÞÊ>ÊvÀ>ÊÀ}>â>ÌÊÃÊii`i`ÊÆ
UÊ >À}ÕiÊvÀÊÌ iÊ>`Û>Ì>}iÃÊvÊ>ÊVi>ÀÊ>V>ÌÊvÊÀiëÃLÌiÃÊ>`Ê>VÌÛÌiÃÊÆÊ UÊ `iÃVÀLiÊ>>}ii̽ÃÊÀiÃÊ>`ÊÀiëÃLÌiÃÊÆÊ
UÊ ÃÕ>ÀâiÊÌ iÊV iVÃÊ>`ÊL>>ViÃÊ«VÌÊÊÌ iÊÕÃiÊvÊ«iiÀÊÀiÛiÜÊ>`ʵÕ>ÌÞÊ assurance (QA) surveillance ;
UÊ iÝ«>ÊÌ iÊ«À>VÌV>Ê«ÕÀ«ÃiÊvÊÌ iÊ`VÕiÌÃÊÛÛi`Ê\ʵÕ>ÌÞÊ«VÞ]ÊÀ}>â>- tional chart, job description, curriculum vitae (CV) ;
UÊ «À`ÕViÊ>Ê`iÊLÊ`iÃVÀ«ÌÊvÀÊÌ ÀiiÊ`vviÀiÌÊÀið
38
TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Session 2:1:2 Session 2:1:1
39
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 2:1:4 Session 2:1:3
40
TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Session 2:1:5
Session 2:1:6
41
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 2:1:8 Session 2:1:7
42
TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Session 2:1:9
Session 2:1:10
43
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 2:1:12 Session 2:1:11
44
TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Questions
ÊUÊ 7 Êà Õ`ÊÃÃÕiÊ>ʵÕ>ÌÞÊÃÌ>ÌiiÌÊÉÊ«VÞʶÊ7 ÞÊà Õ`ÊÌ iÞÊ`ÊÌ Ãʶ
ÊUÊ 7 >ÌÊ>ÀiÊÌ iÊÕÊÀiÃÊii`i`ÊvÀÊÃÌÕ`iÃÊ«iÀvÀi`ÊÕ`iÀÊ+* ,ʶ
ÊUÊ 7 ÞÊÃÊÌ iÊ«ÀV«>ÊÃViÌÃÌÊ>ÊiÞÊ«ÃÌʶÊiÃVÀLiÊÌ iÊÀiëÃLÌiÃÊ>`Ê>VÌÛÌiÃÊ of this person.
ÊUÊ 7 ÊÃÊ+ʶÊ7 >ÌÊ>ÀiÊ+½ÃÊ>ÊÀiëÃLÌiÃʶÊ`i>Þ]Ê+Êà Õ`ÊLiÊ`i«i`iÌÊ of the organization performing scientific study activities – why ?
ÊUÊ 7 >ÌÊ>ÀiÊÌ iÊ«ÕÀ«ÃiÃÊvÊ>ÊLÊ`iÃVÀ«Ìʶ
ÊUÊ 7 ÞÊ`iÃÊ>ÊÃÌÌÕÌÊii`ÊÌÊii«Ê6ÃÊvÀÊ>ÊÃÌ>vvʶ
ÊUÊ 7 ÞÊÃÊÌÀ>}Ê>ÊVÀiÊ>VÌÛÌÞÊvÀÊ>V iÛ}Ê } ʵÕ>ÌÞÊÊL>ÃVÊLi`V>ÊÀiÃi>ÀV ʶ
ÊUÊ 7 ÞÊà Õ`ÊÌÀ>}ÊLiÊ`VÕiÌi`ʶÊ
ÊUÊ 7 ÞÊÃÊÌÊ«ÀÌ>ÌÊÌÊii«ÊÌÀ>}ÊÀiVÀ`ÃÊvÀÊ«iÀÃiʶ
Workshops
1. Taking one of your own (or your department’s) studies as an example, describe what roles are active and who (job title) occupies these roles. Tabulate responsibilities, roles and job titles. Identify any roles that are missing ; situations in which two people appear responsible for the same activity ; or responsibilities that are not covered.
DISCUSSION
UÊ ÕÊÀiÃÊÀiµÕÀi`Ê>ÀiÊ\Ê«ÀV«>ÊÃViÌÃÌ]ÊÌiV V>ÊÉÊ>ÃÃÃÌ>Ì°Ê UÊ "Ì iÀÊÀiÃÊVÕ`ÊVÕ`iÊ>Ê>>}iiÌÊÀi«ÀiÃiÌ>ÌÛi]Ê>`ÛÃÀÞÊVi>}Õi]Ê
ÃÌ>ÌÃÌV>]ÊëiV>âi`ÊÃViÌÃÌÊVÌÀLÕÌ}Ê`>Ì>]Ê>ÀV ÛÃÌ]ÊÃiiÊÜ Ê
«iÀvÀÃÊ«iiÀÊÀiÛiÜ°
UÊ ÃÊÌ iÀiÊVi>ÀÊ`ÃÌVÌÊLiÌÜiiÊÌ iÊLÊÌÌiÃ]ÊÀiÃÊ>`ÊÌ iÊ`vviÀiÌÊÃiÌÃÊvÊ ÀiëÃLÌiÃÊqÊÀÊÌʶÊ
UÊ i>ÀÊ >V>ÌÊ vÊ ÀiëÃLÌiÃÊ Ê >Ê Vi>ÀÊ À}>â>Ì>Ê ÃÌÀÕVÌÕÀiÊ ÃÊ >Ê
«ÀiÀiµÕÃÌiÊvÀÊ}`Ê«À>VÌVi°
45
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
2. In your discussion group, for each of your institutions, make a chart showing the inci- dence of the following : a quality policy, a QA group, routine use of peer review, use of job descriptions, use of training records. If any of these are missing, how would you propose to introduce them ?
DISCUSSION
UÊ -iÊÃÌÌÕÌÃÊÜÊ >ÛiÊ>ʵÕ>ÌÞÊ«VÞ]Ê+]Ê«iiÀÊÀiÛiÜ]ÊLÊ`iÃVÀ«ÌÃÊ
>`ÊÌÀ>}ÊÀiVÀ`ÃÊÆÊÃiÊÜÊÌ°ÊÛ`Ê>ÞÊÕ`}iÌ>Ê>ÌÌÌÕ`i°Ê
UÊ / iÃiÊ ÌÃÊ >ÀiÊ Ìi`i`Ê ÌÊ ÃÌÀi}Ì iÊ Ì iÊ ÀiÃi>ÀV Ê «ÀViÃÃÊ >`Ê Ì iÀivÀiÊ iÃÕÀiÊ`>Ì>ʵÕ>ÌÞÊ\Ê
ÊÊ µÕ>ÌÞÊ«VÞÊ`iÃVÀLiÃÊ>>}ii̽ÃÊiÝ«iVÌ>ÌÃÊvÊiÛiÀÞiÊ>ÌÊÌ iÊ
ÃÌÌÕÌÊÆÊ
ÊÊ +Ê ÃÕ««ÀÌÃÊ Ì iÊ VÃÌÀÕVÌÊ vÊ >Ê µÕ>ÌÞÊ ÃÞÃÌiÊ -"*ÃÊ >`Ê Ì iÀÊ
`VÕiÌ>Ì®]Ê ÃiÀÛiÃÊ >ÃÊ >Ê ÜÌiÃÃÊ ÌÊ Ì iÊ ÃViÌvVÊ >VÌÛÌiÃÊ >`Ê
>Õ`ÌÃÊÌ iÊ`>Ì>Ê>`ÊÀiÃi>ÀV Ê«ÀViÃÃiÃÊÆ
ÊÊ «iiÀÊÀiÛiÜÊ>iÃÊÌÊÕÌ Ài>Ìi}ÊÌÊ`ÃVÕÃÃÊ>VÌÛÌiÃÊ>`Ê`>Ì>ÊÜÌ Ê
>Ê Üi`}i>LiÊ Vi>}ÕiÊÆÊ Ì iÊ «ÀÌ>ÌÊ ÀiÊ vÊ ÀiÛiÜiÀÊ ÜÊ LiÊ
>VVÀ`i`Ê«ÀiÃÌ}iÊ>`ÊÀiÃÕÀViÃÊÆ
ÊÊ LÊ`iÃVÀ«ÌÃÊVi>ÀÞÊÃÌ>ÌiÊÌ iÊiÝ«iVÌ>ÌÃÊvÀÊi>V Ê`Û`Õ>Ê>`Ê i«Ê «ÀiÛiÌÊ `Õ«V>ÌÊ ÀÊ ÃÃÊ vÊ Ì>ÃÃÊÆÊ ÌÀ>}Ê ÀiVÀ`ÃÊ Ã ÜÊ Ü >ÌÊÌÀ>}Ê >ÃÊLiiÊÀiViÛi`°
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TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
3. Write job descriptions for one or two persons in the group (bullet points rather than full text), using the points mentioned in slide 11 of the PowerPoint presentation on organization and quality.
4. Write a job description for the managers or assistants of one or two other persons in the group.
DISCUSSION
UÊ -iÊ«>ÀÌV«>ÌÃÊÜÊLiÊv>>ÀÊÜÌ ÊLÊ`iÃVÀ«ÌðÊ/ iÀiÊ>ÞÊLiÊÃiÊ Ã ÞiÃÃÊLiV>ÕÃiÊLÃÊvÌiÊVÌ>ÊÕÃÌ>Ìi`ÊiÝ«iVÌ>ÌÃÊÀÊ`ÕÌiðÊ
UÊ Ã«iV>ÞÊÊÃ>ÊÃÌ>ÀÌÕ«ÊÃÌÌÕÌÃÊÜ iÀiÊiÛiÀÞiÊÃÊiÝ«iVÌi`ÊÌÊi`Ê>Ê >`]Ê >Ê LÊ `iÃVÀ«ÌÊ } ÌÊ LiÊ VÃ`iÀi`Ê ÌÊ ÌÊ viÝLÌÞÊ ÀÊ «ÀiÃiÌÊ
«ÌiÌ>Ê VvVÌÊ LÞÊ `Û`}Ê `iÃÀ>LiÊ >`Ê Õ`iÃÀ>LiÊ Ì>ÃÃÊ LiÌÜiiÊ Ì iÊ
>Û>>LiÊÜÀvÀVi°
UÊ ÊÀi>ÌÞ]Ê>ÊLÊ`iÃVÀ«ÌÊ\Ê
UÊ V>ÀviÃÊ>Ê«iÀýÃÊÀiëÃLÌÞÊ>`Ê>VÌÛÌiÃÊÆÊ
ÊÊ «ÀiÛiÌÃÊ iVÀ>V iÌÊ vÀÊ Ì iÀÊ «i«iÊÉÊÀiÃÊ >`Ê >LÀ}>ÌÊ vÊ ÀiëÃLÌiÃÊÆÊ
ÊÊ «ÀÛ`iÃÊ>Ê}`ÊÌÊvÀÊ>ÃÃiÃÃiÌ]Ê>}ÊÜÌ ÊÌ iÊÌÀ>}ÊÀiVÀ`ÊÆÊ ÊÊ «ÀÛ`iÃÊ >Ê vÀÊ «>ÌvÀÊ vÀÊ >ÞÊ `ÃVÕÃÃÊ LiÌÜiiÊ i«ÞiiÊ >`Ê
manager.
UÊ *>ÀÌV«>ÌÃÊà Õ`ÊÜÀÌiÊÌ iÀÊ>>}iÀ½ÃÊLÊ`iÃVÀ«ÌÊÊÀ`iÀÊÌÊ>««Ài- V>ÌiÊ>ÞÊ`vviÀiViÃÊÀÊÌ®ÊÊÌ iÀÊÌ>ÃðÊ
UÊ *>ÀÌV«>ÌÃÊà Õ`ÊÜÀÌiÊÌ iÀÊ>ÃÃÃÌ>̽ÃÊLÊ`iÃVÀ«ÌÊÌÊÃiiÊ ÜÊÌ >ÌÊLÊ vÌÃÊÌÊÌ iÊÜ iÊëiVÌÀÕÊvÊ>VÌÛÌÞ°
47
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
2.2 PHYSICAL RESOURCES
Goals
At the end of the session, you should be able to :
ÊUÊ `iÃVÀLiÊ«ÀÌ>ÌÊv>VÌÀÃÊÌÊVÃ`iÀÊÜ iÊLÕ`}ÊiÜÊv>VÌiÃÊÆ ÊUÊ >À}ÕiÊvÀÊÌ iÊ«ÀÌ>ViÊvÊÃi«>À>Ì}Ê>VÌÛÌiÃÊÊÀiÃi>ÀV Êv>VÌiÃÊÆ ÊUÊ `iviÊ`vviÀiÌÊÜ>ÞÃÊvÊÃi«>À>Ì}Ê>VÌÛÌiÃÊÆ
ÊUÊ «ÀÛ`iÊ iÝ>«iÃÊ Ê Ü V Ê Ãi«>À>ÌÊ vÊ ÀiÃi>ÀV Ê >VÌÛÌiÃÊ ÃÊ vÕ`>iÌ>Ê ÌÊ Ì iÊ integrity of research ;
ÊUÊ `vviÀiÌ>ÌiÊLiÌÜiiÊÌ iÊÃViÌÃ̽ÃÊÀiëÃLÌÞÊvÀÊ`iV`}ÊÜ >ÌÊiµÕ«iÌÊÌÊÕÃiÊ and the need to ensure that all equipment functions correctly ;
ÊUÊ >À}ÕiÊ vÀÊ Ì iÊ ii`Ê ÌÊ «iiÌÊ V>LÀ>ÌÊ >`Ê >Ìi>ViÊ «ÀVi`ÕÀiÃÊ ÜÌ Ê >Ê research organization ;
ÊUÊ `ÃÌ}Õà ÊLiÌÜiiÊ«ÀiÛiÌÛiÊ>Ìi>ViÊ>`ÊÀi«>ÀÊÆ
ÊUÊ `iÃVÀLiÊ Ü >ÌÊ `VÕiÌÃÊ >ÀiÊ ii`i`Ê ÌÊ iÃÕÀiÊ vÕÊ ÌÀ>Vi>LÌÞÊ vÊ V>LÀ>ÌÊ >`Ê maintenance ;
ÊUÊ `iÃVÀLiÊÌ iÊVÌiÌÊ>`ÊÕÃiÊvÊ>Êv>ÕÌÊ>VÌÊÀi«ÀÌ°
48
TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Session 2:2:2 Session 2:2:1
49
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 2:2:3
Session 2:2:4
50
TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Session 2:2:6 Session 2:2:5
51
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 2:2:7
Session 2:2:8
52
TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Session 2:2:10 Session 2:2:9
53
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 2:2:11
Session 2:2:12
54
TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Session 2:2:14 Session 2:2:13
55
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Session 2:2:15
Session 2:2:16
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TRAINER Session 2 UÊ+* ,Ê/À>}Ê>Õ>
Questions
ÊUÊ 7 >ÌÊÃÊÃi«>À>ÌÊvÊ>VÌÛÌiÃÊÜÌ Ê>Êv>VÌÞʶÊ7 ÞÊÃÊÌ ÃÊVVi«ÌÊ«ÀÌ>ÌÊvÀÊ the integrity of research ?
ÊUÊ ÛiÊiÝ>«iÃÊÌÊÃ ÜÊ ÜÊ>ÊÀiÃi>ÀV Ê«ÀiVÌÊVÕ`ÊLiÊV«ÀÃi`ÊLÞÊv>ÕÀiÊÌÊ separate research activities.
ÊUÊ ÛiÊiÝ>«iÃÊvÊ« ÞÃV>ÊÃi«>À>ÌÃÊvÀiµÕiÌÞÊvÕ`ÊÊ>ÊÀiÃi>ÀV ÊiÛÀiÌ°
ÊUÊ iÃÊÃi«>À>ÌÊvÊ>VÌÛÌiÃÊ>Ü>ÞÃÊÀiµÕÀiÊ« ÞÃV>ÊÃi«>À>ÌʶÊÊÜ >ÌÊÌ iÀÊÜ>ÞÃÊ could this separation be achieved ?
ÊUÊ 7 ÞÊÃÊÌ iÊÃÕÌ>LÌÞÊvÊiµÕ«iÌÊÃ>`ÊÌÊLiÊ>ÊÃViÌvVÊÀiëÃLÌÞÊÀ>Ì iÀÊÌ >Ê an aspect of quality management ?
ÊUÊ 7 >ÌÊÃÊÌ iÊ`vviÀiViÊLiÌÜiiÊ>Ê«À>ÀÞÊ>`Ê>ÊÃiV`>ÀÞÊÜÀ}ÊÃÌ>`>À`ʶ
ÊUÊ 7 >ÌÊ-"*ÃÊ`ÊÞÕÊÌ Ê>ÀiÊÀiµÕÀi`ÊvÀÊiµÕ«iÌÊÕÃi`ÊÊ>Ê>LÀ>ÌÀÞʶ
ÊUÊ ÛiÊÃiÊiÝ>«iÃÊvÊ«ÀiÛiÌÛiÊ>Ìi>ViÊ«iÀvÀi`ÊÊÞÕÀÊÜÊÀ}>â>Ì°
ÊUÊ 7 >ÌÊ i>`}ÃÊà Õ`ÊLiÊVÕ`i`ÊÊ>Êv>ÕÌÊ>VÌÊÀi«ÀÌʶÊ7 ÊÜÕ`ÊÜÀÌiÊÌÊ¶Ê To whom should it be sent ?
ÊUÊ 7 >ÌÊÜÕ`Ê>ÊÃÌ>`>À`Ê}LÊVÌ>ʶ
ÊUÊ 7 >ÌÊÜÕ`Ê>ÊÃÌ>`>À`Ê>««>À>ÌÕÃÊviÊVÌ>ʶ
57
Session 2 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINER
Workshops
1. Taking as examples two different pieces of equipment with which you are familiar, use a flip chart to describe :
a. how you would determine suitability for use
b. how you would recommend that calibration be performed
c. documents you would consider necessary to support the traceability of all actions involving the equipment.
DISCUSSION
>°ÊiÌiÀ}ÊÃÕÌ>LÌÞÊvÀÊÕÃiÊqÊÌ iÊ>««À>V Ê`i«i`ÃÊÊÌ iÊiµÕ«iÌÊLÕÌÊ
>ÞÊVÕ`iÊ\
Ê Ã«iÊ ÃÌ>ÌiiÌÊ Ì >ÌÊ iµÕ«iÌÊ >ÃÊ LiiÊ ÕÃi`Ê ÀÕÌiÞÊ >`Ê }ÛiÊ Ã>ÌÃv>VÌÀÞÊÀiÃÕÌÃÊÊÌ iÊÀ>}iÊiÝ«iVÌi`ÊvÀÊÌ iÊÀiÃi>ÀV ÊÌi`i`ÊÆ
Ê ÃÌ>ÌiiÌÊÀiviÀÀ}ÊÌÊÌ iÊÌiÀ>ÌÕÀiÊÊÕÃiÊvÊÌ iÊiµÕ«iÌÊÕ`iÀÊÌ iÊ Ã>iÊV`ÌÃÊÆ
Ê ÜÀÌÌiÊ ViÌÊ Ì >ÌÊ ÕÃiÊ vÜÃÊ ºÊ>Õv>VÌÕÀiÀ½ÃÊ ÀiVi`>ÌÊ»Ê qÊÃÊÌ ÃÊÃÕvvViÌʶÊ
Ê >ÊÃÕÌ>LÌÞÊÌiÃÌÊ>ÃÃV>Ìi`ÊÜÌ ÊÌ iÊiµÕ«iÌÊ>`ÊÌ iÊ`ÊvÊÜÀÊ
i°}°Ê>>ÞÌV>ÊiÌ `®ÊvÀÊÜ V ÊÌÊÃÊLi}ÊÕÃi`ÊÆ
Ê vÀ>ʵÕ>vV>ÌÊÃÌ>>ÌʵÕ>vV>Ì]Ê«iÀ>Ì>ʵÕ>vV>Ì]Ê
«ÀViÃÃʵÕ>vV>Ì®°
L°Ê *iÀvÀ}Ê V>LÀ>ÌÊ qÊ Ì ÃÊ `iVÃÊ >ÃÊ `i«i`ÃÊ Ê Ì iÊ iµÕ«iÌÊ LÕÌÊ Ã Õ`ÊVÃ`iÀÊÌ iÊvÜ}Ê\
Ê V>LÀ>ÌÊ`iÃÌÀ>ÌiÃÊÌ >ÌÊiµÕ«iÌÊÃÊÀÕ}ÊÜÌ Ê>VVi«Ì>LiÊ
ÌÃ]Ê Ì iÀivÀiÊ Ì iÊ À>}iÃÊ vÊ Ì iÊ iµÕ«iÌÊ Ã Õ`Ê LiÊ ÃiÌÊ LÞÊ V-
«>ÀÃÊÜÌ ÊÜ >ÌÊÃÊLi}Êi>ÃÕÀi`ÊÆ
Ê vÀiµÕiVÞÊ vÊ V>LÀ>ÌÊ Ã Õ`Ê LiÊ vÝi`Ê LivÀiÊ i>V Ê ÕÃiÊ °i°Ê `>Þ]Ê ÜiiÞ]ÊÌ Þ®ÊÆ
Ê Ê>`Û>Vi]ÊiÃÌ>Là ÊÜ >ÌÊ>VÌÊà Õ`ÊLiÊÌ>iÊÊÌ iÊV>ÃiÊvÊV>- LÀ>ÌÊ Ü V Ê ÃÊ ÕÌÊ vÊ À>}iÊ qÊ ÃiÊ iµÕ«iÌÊ V>Ê LiÊ VÃ`iÀi`Ê Ã>ÌÃv>VÌÀÞÊ«ÀÛ`i`ÊÌÊÃÊÜÌ Ê>ÊvÝi`Ê«iÀViÌ>}iÊvÊÜ >ÌÊÃÊiÝ«iVÌi`°