Clean Room Design A Complete Guide - 2020 Edition. Gerardus Blokdyk

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      16. Have all basic functions of Clean room design been defined?

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      17. Has everyone on the team, including the team leaders, been properly trained?

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      18. Is data collected and displayed to better understand customer(s) critical needs and requirements.

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      19. Will a Clean room design production readiness review be required?

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      20. How does the Clean room design manager ensure against scope creep?

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      21. What are (control) requirements for Clean room design Information?

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      22. What is a worst-case scenario for losses?

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      23. How do you gather requirements?

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      24. What is the definition of success?

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      25. Have specific policy objectives been defined?

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      26. What baselines are required to be defined and managed?

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      27. Is there a completed, verified, and validated high-level ‘as is’ (not ‘should be’ or ‘could be’) stakeholder process map?

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      28. What are the requirements for audit information?

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      29. How do you gather Clean room design requirements?

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      30. Is the team adequately staffed with the desired cross-functionality? If not, what additional resources are available to the team?

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      31. Are different versions of process maps needed to account for the different types of inputs?

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      32. How was the ‘as is’ process map developed, reviewed, verified and validated?

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      33. What information do you gather?

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      34. How can the value of Clean room design be defined?

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      35. How will variation in the actual durations of each activity be dealt with to ensure that the expected Clean room design results are met?

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      36. What are the compelling stakeholder reasons for embarking on Clean room design?

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      37. What gets examined?

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      38. Does the scope remain the same?

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      39. How will the Clean room design team and the group measure complete success of Clean room design?

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      40. What are the record-keeping requirements of Clean room design activities?

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      41. Who approved the Clean room design scope?

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      42. Do the problem and goal statements meet the SMART criteria (specific, measurable, attainable, relevant, and time-bound)?

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      43. What constraints exist that might impact the team?

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      44. What are the boundaries of the scope? What is in bounds and what is not? What is the start point? What is the stop point?

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      45. What is the context?

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      46. Are improvement team members fully trained on Clean room design?

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      47. The political context: who holds power?

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      48. Has your scope been defined?

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      49. What specifically is the problem? Where does it occur? When does it occur? What is its extent?

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      50. When is the estimated completion date?

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      51. Who is gathering Clean room design information?

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      52. What knowledge or experience is required?

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      53. If substitutes have been appointed, have they been briefed on the Clean room design goals and received regular communications as to the progress to date?

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      54. What are the dynamics of the communication plan?

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      55. How do you manage scope?

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      56. Is there a clear Clean room design case definition?

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      57. Is the work to date meeting requirements?

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      58. What is out-of-scope initially?

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      59. How would you define the culture at your organization, how susceptible is it to Clean room design changes?

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