Demonstration: How does the tool work? KIT Biomedical Research, Royal Tropical Institute, Amsterdam, The Netherlands

Transcription

1 Demonstration: How does the tool work? Tjeerd Datema, MSc KIT Biomedical Research, Royal Tropical Institute, Amsterdam, The Netherlands

2 Goal To present the GLI Implementation Guide for implementing a quality management system at the NRL level Please note: The GLI Implementation Guide is under construction, i.e.: Format not definitive; Not all templates have been added; Templates not reviewed, etc 2

3 Background Different types of documents for establishing a quality management system leading to accreditation: Standards Useful for overview on all requirements to a QMS Guidelines Useful for deeper understanding of meaning of requirements Checklists Useful for assessors and managers to map progress 3

4 Background User: Laboratory manager & quality officer User questions: What are the activities I need to undertake to achieve compliance to the ISO standard? What exactly do I have to do for each activity? What should I do now and what can wait? What should I include and leave out of this document to make it complete and complying with the standard? 4

5 Background What does the laboratory manager/ quality officer need? Translation of standard-requirements into specific activities A description of what should exactly be done in each activity A phased approach To get a grasp of what it should look like: supply of background information, templates of documents, tools, directives, etc Checklist to measure in how far the QMS has been established and what still needs attention 5

6 Method ISO requirements Translated into TB specific requirements Requirements translated into activities Activities allocated to 4 levels Activities supplemented with descriptions Templates / tools / background info added 6

7 Activity Description of activity Explanation on what should exactly be done in the activity. Hyperlinks lead to templates. Generic SOP on AFB microscopy Stock and ordering software Biosafety requirements List of courses into quality management 7

8 ISO 15189:2007, Specific instructions for the proper collection and handling of primary samples shall be documented and implemented by laboratory management (see 4.2.4) and made available to those responsible for primary sample collection. These instructions shall be contained in a primary sample collection manual. Activity: Write a service manual and start to follow the procedures formulated in this manual. 8

9 Description: This manual must describe what clients can expect from you (services that you provide, contact details, turnaround time) and also what you expect from your clients (specimen specifications, request forms, transportation requirements). Follow all procedures formulated in the service manual. E.g., check all specimens received by the laboratory on compliance with the acceptance/rejection criteria formulated in the service manual. If the sample is not complying with these criteria, follow the procedure also described in the manual. Send this manual to all the clients of the laboratory. Each time the service manual is revised, the new copies should be send to all the clients of the laboratory together with an indication of what has changed compared to the previous version. 9

10 Write a service manual and start to follow the procedures formulated in this manual. This manual must describe what clients can expect from you (services that you provide, contact details, turnaround time) and also what you expect from your clients (specimen specifications, request forms, transportation requirements). Follow all procedures formulated in the service manual. E.g., check all specimens received by the laboratory on compliance with the acceptance/rejection criteria formulated in the service manual. If the sample is not complying with these criteria, follow the procedure also described in the manual. Generic service manual Send this manual to all the clients of the laboratory. Each time the service manual is revised, the new copies should be send to all the clients of the laboratory together with an indication of what has changed compared to the previous version. 10

11 Important: The implementation guide provides templates of generic documents This means that all templates need extensive review and adaption to the local situation. 11

12 Activities allocated to CLSI Quality System Elements (QSEs): 1. Facilities and Safety 2. Organization 3. Personnel 4. Equipment 5. Purchasing and Inventory 6. Process Control 7. Information Management 8. Documents and Records 9. Customer Service 10.Assessment 11.Occurrence Management 12.Process Improvement 12

13 Four levels of implementation: Each level has a specific focus Not aimed at different levels of laboratories but at different phases of implementation of ISO requirements 13

14 QSE 1 Level 1 Level 2 Level 3 Level 4 QSE 2 QSE 3 QSE 4 QSE 5 QSE 6 QSE 7 QSE 8 QSE 9 QSE 10 QSE 11 QSE 12 14

15 Level 1 Goal: To ensure that the primary process operates correctly and safely. Description: At this level the fundaments of a quality management system (QMS) will be set up. The major activities include: Formation of a quality project team. Training Writing of SOPs for the primary process only Writing of SOPs for equipment and maintenance Upgrading of laboratory safety 15

16 Level 2 Goal: To control and assure quality, create traceability. Description: Major activities include: SOPs for all processes Traceability through design and use of forms Document control system Organization of regular meetings 16

17 Level 3 Goal: To ensure proper management and organization. Description: Leadership and planning are essential. Major activities include: Policy cycle, development of a vision and mission, turning into policy and policy into planning. Management review and quality year plans. Quality manual Internal auditing system. Start recording and handling of complaints, notifications and improvement suggestions. 17

18 Level 4 Goal: Ensure continuous improvement and building up evidence. Description: In essence the complete quality management system has been created and implemented at levels 1 to 3. at level 4 the system needs to run for a certain period: Build up evidence Prove that it really is a cycle; Validation of all methods and equipment Automatic continuous improvement Apply for accreditation 18

19 Demonstration Demonstration of the DRAFT GLI Implementation guide 19

20 Final format Different possibilities Digital USB Memory stick CD-Rom Internet Paper version Implementation guide printed on paper, templates and tools added on CD-rom. Clear reference system is necessary from implementation guide to CD-rom. 20

21 What s next Review and refine the implementation guide Optimize and add templates, tools, etc. Add checklists to each level Decide on the final format Develop a plan to support the roll-out and country uptake of the implementation guide. 21

22 Implementation guide on USB-memory stick/cd-rom Implementation guide is distributed on USB-memory stick or CD-rom. Contents: Questions: 22

23 Acknowledgements Chris Gilpin Tom Shinnick John Ridderhof Armand van Deun Jerod Scholten Martin Baker Arnold Herrewegh Paul Klatser Linda Oskam Mirjam Engelberts Stella van Beers Questions and remarks to: Tjeerd Datema