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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60.