PROACTIVE APPROACHES. for QUALITY MANAGEMENT. Anabela Martins Micoteca da Universidade do Minho

Transcription

1 PROACTIVE APPROACHES for QUALITY MANAGEMENT Anabela Martins Micoteca da Universidade do Minho 1

2 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 2

3 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 3

4 4

5 Method Establishment of the scope Recognition scheme and type of standard Establishment of the type of S, structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 5

6 Method Establishment of the scope Recognition scheme and type of standard Establishment of the type of S, structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 6

7 Method Establishment of the scope Recognition scheme and type of standard Establishment of the structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 7

8 Method Establishment of the scope Recognition scheme and type of standard Establishment of the structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 8

9 Method Establishment of the scope Recognition scheme and type of standard Establishment of the type of S, structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 9

10 Method Establishment of the scope Recognition scheme and type of standard Establishment of the type of S, structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 10

11 Method Establishment of the scope Recognition scheme and type of standard Establishment of the type of S, structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 11

12 Method Establishment of the scope Recognition scheme and type of standard Establishment of the type of S, structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 12

13 Method Establishment of the scope Recognition scheme and type of standard Establishment of the type of S, structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 13

14 Method Establishment of the scope Recognition scheme and type of standard Establishment of the type of S, structure and provisions Standard development Commenting stages Discussion inside the TC Standard in DIS stage (general procedure) Public consultation Taking comments into account Standard publishing Anabela Martins, ISO TC 276 Biotechnology 14

15 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 15

16 Method - OECD BPG NFS Quality management of BRCs and quality of biological resources Reference sources - NCI Best Practices - UK Biobank Quality Standards - MMI Guidelines for Standardized Biobanking - ISO ISO/IEC Anabela Martins, ISO TC 276 Biotechnology 16

17 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 17

18 4. General requirements 5. Structural requirements 6. Resource requirements 7. Processes requirements 8. Management requirements - Option A Option B Annex A Documentation requirements 18

19 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 19

20 It conveys two main kinds of provisions: Requirements Recommendations 20

21 RECOMMENDATION "expression (...) conveying a suggested possible choice or course of action deemed to be particularly suitable without necessarily mentioning or excluding others." should 21

22 REQUIREMENT "expression in the content of a document (...) from which no deviation is permitted if compliance with the document is to be claimed." shall 22

23 REQUIREMENTS clear, objective and verifiable 23

24 REQUIREMENTS Must not block innovation and flexibility in biobanks - they should be expressed in terms of process management and performance criteria 24

25 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 25

26 Accreditation of Biobanks Recognition of the technical competence of biobanks to perform testing on biological material 26

27 Certification The auditor must have technical competence in the specific technical area 27

28 International Laboratory Accreditation Cooperation (ILAC) International Accreditation Forum (IAF) National / Regional Accreditation body (AB) ISO / IEC Biobanking Testing Laboratories Medical Testing Laboratories Calibration Laboratories Inspection bodies Certification bodies ISO ISO/IEC ISO ISO/IEC ISO/IEC ISO/IEC BM testing Assays in many fields including medical field Assays in medical field such as clinical and genetics Calibration of equipment used to measure mass, temperature, pressure, etc.. Inspection in several fields such as vehicle, gas, welding, etc.. Management systems certification Personnel certification Product / service certification

29 International Laboratory Accreditation Cooperation (ILAC) International Accreditation Forum (IAF) National / Regional Accreditation body (AB) ISO / IEC Testing Laboratories Medical Testing Laboratories Calibration Laboratories Inspection bodies Certification bodies ISO/IEC ISO ISO/IEC ISO/IEC ISO/IEC ISO/IEC ISO/IEC Assays in many fields including medical field Assays in medical field such as clinical and genetics Calibration of equipment used to measure mass, temperature, pressure, etc.. Inspection in several fields such as vehicle, gas, welding, etc.. Certification of management systems Certification of personnel Certification of. products or. processes or. services

30 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 30

31 Comments ISO 31

32 National Standard Body Deadline:??? Deadline: Oct 11 Comments ISO 32

33 How to find the National Standard Body contact 33

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35 PT 5.1 note Justification Provision re-written ge / te / ed - general - technical - editorial 35

36 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 36

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38 Microorganism disposal Fail Fail Fail Fail Microorganism tested Microorganism tested for Q Microorganism tested for Q Microorganism tested for Q Microorganism tested for Q Pass Failure detected Pass Failure detected Pass Failure detected Pass Failure detected Pass VIP Process parameters controlled Process parameters controlled Process parameters controlled Transport parameters controlled Culture Processing Storage Recovery Transport S Raw material (growth media) Added raw material Periodic checks Testing Testing Fail Microorganism disposal 38

39 Authentic microorganisms Culture Processing Storage Recovery Transport The microorganism preservation for the long-term 39

40 Standard development procedure Reference sources Structure Interpreting the provisions Recognition scheme (foreseen) Procedure for commenting ISO standard Biobanks Quality by Testing Approach Quality by Design Approach 40

41 Design of the preservation process Identification of the sources of variability Understanding the impact of the sources of variability on the CQA Control the sources of variability Identification of product CQA 41

42 Risk Assessment (RA) Design of experiments (DOE) Design space (DS) 42

43 Identification of all the process factors 43

44 Identification of potential risks and their causes 44

45 Scoring the factors in terms of Risk Priority Number (arithmetic product of the I, L and A) 45

46 Screening significant factors influencing CQA Source: Jiju Antony; Design of Experiments for Engineers and Scientists 46

47 Multidimensional combination and interaction of factors that have been demonstrated to provide quality assurance 47

48 How to integrate QbD in a standard? 48

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50 Authentic microorganisms Culture Processing Storage Recovery Transport The microorganism preservation for the long-term 50

51 Thank you for your kind attention

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55 Culture Processing Storage Recovery Transport 55

56 Accreditation Recognition of the technical competence to perform conformity assessment 56

57 Conformity assessment - Testing - Calibration - Inspection - Certification 57

58 Certification Confirmation that certain (specified) characteristics of a product, process, person or organization conform with the requirements 58