TPI NEXT applied for medical. AQSF Fachgruppe Medizintechnik

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1 TPI NEXT applied for medical AQSF Fachgruppe Medizintechnik

2 About b-quality 2

3 Ziele und Anforderungen von Testprozessen Testprozesse (sollen) - Fehler finden - Schwachstellen aufdecken Anforderungen an Testprozesse: - Kommuniziert - Detailliert - Angepasst - Organisiert Wie misst man die Güte des Testprozesses? 3

4 Assessment-Modelle SPICE CMMI TPI Business Excellence CobiT Audit 4

5 Was ist TPI NEXT Test Process Improvement-Model (Assessmentmodell) - Entwickelt von Sogeti - Testprozess steht im Mittelpunkt ABER: - Orientiert sich an der Wertstromkette - Effizienz, nicht Effektivitätsmessung - Original ist generisch und in jeder Branche einsetzbar Ziel: Der Test muss zum Unternehmensziel beitragen! 5

6 TPI Next Testmatix 16 Key Areas 157 Checkpoints Drei Stufen: Controlled, Efficient, Optimizing # Key areas Controlled Efficient Optimizing 01 Stakeholder commitment A B B C F H H K M M 02 Degree of involvement A B C E H H J L L 03 Test strategy A A B E F F H K L 04 Test organization A C C D H H I I J K K 05 Communication B C C D F F J M M 06 Reporting A C C F G G K K 07 Test process management A A B B G H J K M 08 Estimating and planning B B C C G H I I K L L 09 Metrics C C D G H H I K K 10 Defect management A A B D F F H J K L L 11 Testware management B B D E I I J L L L 12 Methodology practice C D E F H J J M M 13 Tester professionalism D D E E G G I I K K M 14 Test case design A A E F I I J K K M 15 Test tools E E E F G G I L M M 16 Test environment C D D E G H J J L M M 6

7 TPI Next Applied for medical Strukturierter Ansatz Reguliert Generisch Risikobedacht Offen Berücksichtigung der relevanten Normen 7

8 Warum die Guideline Hilfsmittel, kein neues Modell Nimmt Bezug auf die Medizintechnik Beinhaltet alle relevanten Standards Gibt konkrete Hilfen 8

9 Example (1/6) Chapter 1: Stakeholder Commitment 01.c.3 Stakeholders actually deliver the committed resources. An item for an easy check... the Stakeholder shall deliver the resources on time, which can be persons or material items. You may find personal by checking the verification and test execution against the project planning and which devices for test have been brought from the development. Documents: verification plan, validation plan, development plan, project plan. 9

10 Example (2/6) Chapter 2: Degree of involvement 02.e.2 Testers contribute to the impact analysis of defects. To ensure and improve the test device and the device s safety, it is recommended to the testers to create an impact analysis about which defect they found and if other weaknesses from the same kind may occur within the product. CAPA process requires to solve the defect and make sure it does not occur again. This might be the a great point for the testers to improve and update their process about the possibility to find issues. 10

11 Example(3/6) Chapter 3: Test Strategy 03.c.3 There is a differentiation in test levels, test types, test coverage and test depth, depending on the analyzed risks. Regulations may require only parts of acceptance testing, system testing, integration or unit testing. Remember, also static code analysis and reviews may be some kind of test. The better way for this checkpoint would be: There is a difference in test levels, test types, test coverage and test depth, depending on the analyzed risks and the documented risk class. These checkpoints may be found at the test specifications or test plans. 11

12 Example(4/6) Chapter 9: Metrics 09.c.3 The input (data) for metrics is provably accurate. Provable accurate is the correct idea about the confidence in a metric and the quality of the outcome decision. To be concrete: The input has to be valid for an possible valid and maybe usable output. Usage and report of the established metric 12

13 Example (5/6) Chapter 10: Defect management 10.c.3 For further handling of defects the responsibilities are defined. With the tracking of a defect and the upcoming action items comes the need of a responsible person who has to work out these items. CAPA SOP, defect tracking 13

14 Example(6/6) Chapter 15: Test tools 15.e.1 Test tools currently used have been selected for testing faster, cheaper, better or making the test process better manageable. In the medical section, the ISO13485 commands you to hold the process quality determinable and continuous, instead of the ISO 9001 continuous improvement is the main factor. For the medical Checkpoint, the attributes of improvement "faster,cheaper,better" are not in scope. The process should be manageable. The complete checkpoint: "Test tools used have been selected for making the test process better manageable." Reports on Tools. 14

15 Last example eins hab ich noch 13.o.3 Testers strive towards accountability and responsibility for their own work and continuous improvement of their work process. The testers want to improve their own process and their daily workflow. For that, they work out own ideas for using and optimizing the methods and take the responsibility about their domain. BE AWARE, the test method instruction, process instruction or SOP and the used template are within version control and may only be changed with a documented process. BE AWARE => CAPA 15

16 Das Assessment Stufenweise Projekte durcharbeiten Nachweise sammeln Vorgehen wir bei einem konzentrierten Audit/Prozessaudit 16

17 und die Folgen Nach dem Assessment ist vor dem Erfolg Daten auswerten TPI Next Matrix Schwachpunkte aufdecken Optimierung bearbeiten! Wichtig ist die Bewertung der Ergebnisse und den Willen zur Veränderung 17

18 Umsetzung 1. Self-Assessment 2. Externe Partner Hilfsmittel: - TPI Tool von der TPI Next Webpage - Guideline für medical 18

19 Assessment und Agilität? Kein Widerspruch! Hohe Prozessreife ist für Agilität erforderlich 19

20 Telefon: Mobil: Skype: stefan.bolleininger Mail: