KEMRI-WELLCOME Standard Operating Procedures (SOPs) – Gain practical skills

  KEMRI-WELLCOME TRUST RESEARCH LABORATORY TRAINING PLAN REPORT FOR QUALITY MANAGEMENT SYSTEM RELATED TRAINING            Report Compiled by:Horace Gumba,KEMRI-Wellcome Trust Research Laboratory Quality Manager   1.      INTRODUCTION AND BACKGROUND INFORMATIONTraining is a process that involves acquisition of knowledge and skills necessary to successfully perform a particular task and can include change of knowledge, skills, behavior and attitudes for better job performance. To achieve this, it is important to have a detailed plan on how the identified training can be conducted to advance the necessary skills and knowledge.This is a summary training plan report of the KEMRI-Wellcome Trust Research Laboratory quality management system (QMS)-related training.

It focuses on advancing skills and knowledge in the identified training needs and is based on the logical framework approach, laying emphasis on the quality management system (QMS) elements that helps in sustaining the laboratory accreditation process. This plan also highlights appropriate training approach, requirements, roles and responsibilities, curriculum and evaluation.1.1  Purpose and scopeThis training plan report identifies the appropriate training strategies and activities required to achieve the desired objectives and required learning outcomes within the laboratory to ensure all identified gaps during Training Needs Assessment (TNA) are resolved. It details the activities and tasks necessary to fulfill the identified training requirements to advance knowledge and skills as well as ability to support the laboratory’s QMS processes and sustain the accreditation status. The table below summarizes the proposed training, its learning outcomes and how this is linked to the gaps identified from the training needs assessment.

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Proposed training Gaps identified from the Training Needs Assessment Objectives/learning outcomes Q-Pulse user training –          Inadequate skills and knowledge of using Q-Pulse system –          Acquire skills and knowledge of using Q-Pulse system –          Ensure that new Q-Pulse users are fully aware of the common features shared    throughout the system –           Enable new users to commence their usage of Q-Pulse based on a sound platform of knowledge SOP writing –          Inadequate skills on writing and  review of Standard Operating Procedures (SOPs) –          Gain practical skills and knowledge of writing SOPs. –          Gain knowledge on SOP concept as an element of Good Clinical Laboratory Practice (GCLP). Good Clinical Laboratory Practice (GCLP) –          No current skills on updated Good Clinical Laboratory Practice (GCLP) standards –          Gain knowledge on updates and improve understanding of the current GCLP standards –          Helps the participants to refresh what they practice and also help them to enhance the good practices expected of the laboratory. Corrective action process –          Inadequate knowledge and skills concerning corrective action process –          Understand the corrective action life cycle process.

–           Understand the root cause analysis in investigation laboratory problems. Internal audit –          Inadequate knowledge and skills in performing an internal audit. –          Understand the internal audit cycle; –          Understand the responsibilities for the preparation, planning, conduct and close out of internal audits. Meeting coordination and management –          Poor skills in coordination and meetings management –          Ensure participants able to conduct and manage meetings either as chairs or secretary. –          Gain understanding of teamwork and communication skills. General equipment preventive maintenance –          Skills in performing equipment preventive maintenance –          Understand the importance of equipment preventive maintenance. –          Gain practical skills on developing preventive maintenance charts from equipment manuals.  1.

2  Overview of this plan documentThis training plan consists of three main sections namely: introduction, the training design and evaluation. The introduction section describes the steps leading up to this training plan, an overview of its contents and as well as highlighting some of the underlying assumptions.The second section, the training design describes the overall goals of the training, instructional design strategy employed, the curricula, methods of training delivery and their advantages and disadvantages, logistics and resources required during the training and the contingency plans. The last section of this plan, the evaluation, mainly describes the metrics, methods of assessing training effectiveness and strategies.1.3  Planning PrinciplesThis plan was developed based on the results of the training needs assessment.

Successful execution of this plan is dependent on the coordination of the training team and the development of the training content that resolves the gaps identified from the training needs assessment. The training team will be meeting often prior to the start of each training to organize and develop a succinct training content tailored to the gaps identified.1.4  Assumptions and ConstraintsThe table below summarizes the identified assumptions and constraints during the conduct of training. Group/Element Assumption Constraints Participants –          All participant will be proficient in basic computer skills before attending the Q-Pulse user training –          Most participants will be knowledgeable in most training like SOP, corrective action, GCLP –          Class size limited to 30 persons per session. Training team –          The training team are experienced and knowledgeable in the areas they will be training. –          The lead facilitators will be assisted with co-facilitators during practical activities –          Most trainers will be internal staff.

Very few external facilitators will be sought due to inadequate funds Training schedule –          The training schedules/agenda developed will have minimal changes during implementation. –          Class size for most training will be limited to 30 persons Training materials –          The training server will be able to support the Q-Pulse system user training. –          Q-Pulse user training will be done on a pilot database and not live. –          Training materials will be made available to participants during the training –          Some of the training materials like presentations will be sent through email because it will be expensive to print. 2.      ROLES AND RESPONSIBILITIESThe laboratory quality assurance manager will form a training team with various roles to ensure the training are conducted successfully.

The table below illustrates the laboratory training roles. Training Responsibility Description of roles Q-Pulse user training –          Laboratory QA manager –          Coordinating and delivering the training as per the suggested training agenda –          Information Technology (IT) officer –          Assist with preparing the computers ready for training SOP writing –          Laboratory QA manager –          Developing training content; coordinating and managing the training –          Clinical trials laboratory manager and Senior laboratory technologists –          Deliver training as per assigned/agreed modules. Good Clinical Laboratory Practice (GCLP) –          Laboratory QA manager –          Coordinating and managing the training –          Accreditation auditor (external facilitator) –          Develop training content and deliver training Corrective action –          Laboratory QA manager –          Develop training content and deliver training Internal audit –          Laboratory QA manager –          Develop training content and deliver training Meeting coordination and management –          Clinical trials laboratory manager and laboratory QA manager –          Develop training content and deliver training General equipment preventive maintenance –          Laboratory QA manager –          Coordinating and managing the training –          Equipment superintendent and equipment assistant –          Assist in developing training content and delivering training. 3.      REQUIREMENTS AND PREREQUISITESThe requirements and perquisites of the identified training, including the training environment, expectations, evaluation criteria are summarized in the table below.

Proposed training Requirements Prerequisites Expectations Evaluation criteria Q-Pulse user training Basic computer skills, Understanding the laboratory QMS None Users able to navigate and use Q-Pulse system End of training questionnaire SOP writing Laboratory personnel Knowledge of existing laboratory SOPs Participants able to write an SOP objectively. Assessing knowledge transfer using questionnaire Good Clinical Laboratory Practice (GCLP) Laboratory personnel Knowledge of GCLP standards Participants to have knowledge on the current GCLP standards Pre-test and post-test evaluation questionnaires Internal audit Laboratory personnel Awareness of the lab QMS processes Participants able to perform an internal audit Assessing knowledge transfer through observation and use of questionnaire Corrective action Personnel working in the laboratory Awareness of the lab QMS processes Participants able to effectively write a corrective action End of training questionnaire General equipment preventive maintenance Equipment custodian, laboratory section heads Able to read the equipment manuals Participants able to develop and perform preventive maintenance. End of training questionnaire 4.      STRATEGY AND APPROACH4.

1  Training Sources Proposed training Source Q-Pulse user training Internal (In-housed) SOP writing Internal ( In-housed) GCLP training External facilitator Internal audit Internal ( In-housed) Corrective Action Process Internal ( In-housed) Meeting coordination and management Internal ( In-housed) General Equipment Preventive Maintenance Internal ( In-housed) The identified training will mainly facilitated by internal laboratory personnel who are experienced and considered competent on the training areas assigned. Only the GCLP training will be facilitated by the accreditation auditor from the accreditation company since they have the latest GCLP standards. The training and their source is indicated below:           4.2  Delivery MethodsThe training approach will be based on principles of adult learning with a focus on follow-up and peer review during the entire training cycle. Training on the identified training needs will employ a variety of effective training methodologies, including practical, brain-storming, discussion and presentation. The training delivery process will include plenary sessions, group exercises, group discussions and recap. The following methodologies will be employed taking into account the training subject, the training participants and the learning outcomes.

a)      Teamwork and group work: Since most adults learn by sharing, forming teams or groups to discuss training content will provide an opportunity to discuss their work experience and problems related to the areas of work.b)     Practical work and examples: This will be applicable to all the identified training and will be blended with activities that involve practical aspects of the work they perform in the laboratory. After topic presentation and explanations, the participants will be provided with an opportunity to practice. c)      Hands-on support after training (Follow-up): This approach will mainly be used for internal audit training and Q-Pulse user training. This will involve monitoring the work of the participants after the end of workshops, coaching and on-the-job training and is aimed in advancing skills in the form of follow-ups.d)     Case studies: This will be blended in all the identified training and will mainly be discussions around some of the problems experienced within the laboratory.  This approach will better understanding of various laboratory problems experienced for proper implementation of improvement ideas.e)      Interactive sessions: This approach will be used in the GCLP and SOP writing training where most participants are already familiar with the concept of the training subject.

f)       On-the-job training: This will be employed to SOP writing training, Corrective action process and internal audit training. This delivery approach involves coaching and access to training materials which are often easy to use and cost-effective since only experienced employees are used to train other staff. Moreover, it promotes gaining of practical skills and knowledge.4.

3  Dependencies All training to be conducted depend on the level of understanding of laboratory quality management system. It will, therefore, be necessary for all participants to be aware of various laboratory procedures and policies. 5.      TRAINING RESOURCES5.1  MaterialsTraining materials will be organized and coordinated two weeks before the start of each  training. Even though the training room has a digital projector and electronic board, flip charts, felt pens and portable projector will be made available as back-up. Training materials like writing materials, user manuals, documented procedures and policies will be printed and made available before the actual start of training.

5.2  StaffingAll training with the exception of the GCLP training that will require external facilitation; will be conducted by a training team composed of internally experienced  laboratory personnel in the areas they will be assigned to train. All participants will be mainly from various laboratory sections.5.3  EquipmentAll the training will be conducted in the computer training room which has 30 desktop personal computer, digital board and digital projector.5.4  EnvironmentThe computer training room is enclosed, climate-controlled, suitable, spacious, equipped with the required training equipment and is very conducive to conduct the training. All training will be conducted in the computer training room.

6.      TRAINING SCHEDULEThe training schedule below identifies the various training to be conducted, number of modules, training dates, target audiences and training duration.   Identified training Number of modules Training dates Target audience Training duration Q-Pulse user training 5 modules 7th-9th March 2018 All laboratory personnel 3 days SOP writing 3 modules 29th-30th March 2018 All laboratory personnel 2 days GCLP training 7 modules 11th-13th April 2018 All laboratory personnel 3 days Internal audit 8 modules 24th-27th April 2018 Laboratory personnel with interest in audit 4 days Corrective Action Process 3 modules 15th-16th May 2018 Laboratory personnel 2 days Meeting coordination and management 4 modules 7th-8th June 2018 Laboratory QA representatives, section heads 2 days General Equipment Preventive Maintenance Equipment superintendent 20th-22nd  June 2018 All laboratory section heads, equipment custodians 3 days 7.

      TRAINING EVALUATIONEvaluation is a critical aspect in the training life cycle. This is because it helps in defining the learning outcomes and ensure the training method meets the training needs of the participants. The training team will formulate a comprehensive evaluation questionnaires with questions covering the training materials, aspects of training and whether learning has taken place. The questionnaires will be anonymous and will be collected at the end of each training. The data collected will be analyzed to provide a dynamic review of the training effectiveness and areas that require improvements. Kirkpatrick’s four levels of evaluation approach will be applied (Kirkpatrick, 2006) to assess the effectiveness of the training. In this model, each evaluation level will be built from the information provided from the previous level. Four different questionnaires will be used to assess the effectiveness of each training as indicated below: Level Measure Evaluation description Tools and methods Time to evaluate 1.

Participant reaction How the participants feel about the training or learning experience Daily participant evaluation questionnaire At the end of each training day 2. Participant learning Assessing if there is an increase in knowledge between before and after training Comparison of the participant pre-test and post-test evaluation questionnaire Pre-test: at the beginning of the training Post-test: at the end of the training 3. Transfer of knowledge Behavior evaluation. Assessing whether learning was implemented back on the job. Facilitators observation at the end of training At the end of training 4.

Institutional impact (Improvement on trained areas) This measures the effectiveness of the training. End of training questionnaire At the end of training 4 8.      TRAINING SECURITY AND UPDATES8.1  Access to Training MaterialTraining presentations will be zipped in one folder and identified by the title of the training. These zipped folders will be kept by the quality assurance manager who has the training laptop. The training team will also have access to the zipped folders since it will be stored in a shared-drive in the server. The participants, however, will not get access to the training materials before the actual start of training. The training agenda will be sent to the participants during invitation while other training materials will be made available to all participants during training.

8.2  Access to training environmentThe computer training room where all training will be conducted is secured through electronic access card. During the entire training period, all participants and the training team will be given access to this room by the help of the information technology team.8.3  Updating Training resourcesThe training team will be meeting two weeks prior to start of each training to develop, review and revise the training curriculum, content and materials where necessary.

All changes made during the training team meetings will be updated and stored in a shared folder accessible to the whole training team.9.      TRAINING CURRICULUMThe training curriculum will be based on the adoption of the practical skills during training and is composed of three interconnected parts. In the first part, participants will acquire practical knowledge about the identified training needs required for sustaining the laboratory accreditation process. Training activities will be implemented through modules during workshops which will be designed to follow the requirements of GCLP standards to which the laboratory is ascribed to.

Each modules will be structured and will be allocated adequate time. The second part of the curriculum will focus on the educating the participants on the existing procedures and policies of the identified training needs. To achieve this, all the participants will be given manuals and copies of documented procedures and policies for references. The third part will be learning through work. This will mainly be through assigning of activities to be worked after completing the training workshops with the support of the training team.

   10.  APPENDICES10.1          Abbreviations and Acronyms GCLP    Good Clinical Laboratory Practice QA Quality Assurance QMS Quality Management Systems SOPs Standard Operating Procedures TNA     Training Needs Analysis For the purposes of this report, the following abbreviations and acronyms apply: 10.2          Training Budget Training Number of persons to be trained Number of training days Cost (Kenya Shillings) Q-Pulse user training 70 3 30,300 SOP writing 35 2 17,200 GCLP 70 3 47,600 Internal audit 12 4 13,920 Corrective action process 70 2 21,000 Meeting coordination and management 20 2 8,800 General equipment preventive maintenance 22 3 16,380 Miscellaneous     44, 800 TOTAL     200,000  10.

3          References1.      Kirkpatrick, D. and Kirkpatrick, J. (2006).

Evaluating training programs. San Francisco, CA: Berrett-Koehler.