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102. Have all basic functions of Regulatory processes been defined?
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103. Are different versions of process maps needed to account for the different types of inputs?
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104. Has a high-level ‘as is’ process map been completed, verified and validated?
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105. Do you all define Regulatory processes in the same way?
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106. Is Regulatory processes required?
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107. Are there any constraints known that bear on the ability to perform Regulatory processes work? How is the team addressing them?
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108. Is the Regulatory processes scope manageable?
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109. Have the customer needs been translated into specific, measurable requirements? How?
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110. What system do you use for gathering Regulatory processes information?
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111. What are the compelling stakeholder reasons for embarking on Regulatory processes?
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112. Are resources adequate for the scope?
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113. What is the scope of the Regulatory processes work?
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114. How are consistent Regulatory processes definitions important?
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115. What are the Roles and Responsibilities for each team member and its leadership? Where is this documented?
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116. How do you gather the stories?
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117. Who approved the Regulatory processes scope?
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118. What would be the goal or target for a Regulatory processes’s improvement team?
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119. What is in scope?
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120. What knowledge or experience is required?
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121. Has everyone on the team, including the team leaders, been properly trained?
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122. Is there regularly 100% attendance at the team meetings? If not, have appointed substitutes attended to preserve cross-functionality and full representation?
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123. Is the team formed and are team leaders (Coaches and Management Leads) assigned?
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124. What is the scope of the Regulatory processes effort?
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125. What are the tasks and definitions?
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126. Are the Regulatory processes requirements complete?
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127. How do you hand over Regulatory processes context?
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128. Is it clearly defined in and to your organization what you do?
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129. What is the worst case scenario?
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130. Are approval levels defined for contracts and supplements to contracts?
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131. Is the Regulatory processes scope complete and appropriately sized?
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132. Has the improvement team collected the ‘voice of the customer’ (obtained feedback – qualitative and quantitative)?
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133. Has the Regulatory processes work been fairly and/or equitably divided and delegated among team members who are qualified and capable to perform the work? Has everyone contributed?
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134. What are the Regulatory processes use cases?
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135. What defines best in class?
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136. Is there a clear Regulatory processes case definition?
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137. What is the scope?
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138. Do the problem and goal statements meet the SMART criteria (specific, measurable, attainable, relevant, and time-bound)?
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139. Are roles and responsibilities formally defined?
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140. How have you defined all Regulatory processes requirements first?
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Add up total points for this section: _____ = Total points for this section
Divided by: ______ (number of statements answered) = ______ Average score for this section
Transfer your score to the Regulatory processes Index at the beginning of the Self-Assessment.
CRITERION #3: MEASURE:
INTENT: Gather the correct data. Measure the current performance and evolution of the situation.
In my belief, the answer to this question is clearly defined:
5 Strongly Agree
4
