2. Investigation and Planning Phase:
Investigation:
☒ If used, Investigation and Planning Worksheet is referenced and attached.
☒ Problem Statement is objective, concise and clear.
☒ All attachments referenced are included in Windchill.
☒ Root Causes Analysis is attached as applicable (templates in) and includes justification.
☒ All events included in the problem statement were investigated.
☒ Investigation details are clear, redacted, in chronological order and can be understood by an
independent reader.
☒ Root Cause Categories are completed appropriately
☒ The numbering and title of attachments is adequate
Planning:
☒ All root causes have at least one action proposed.
☒ Action plan includes detailed description, owner and due dates (using blue “i”).
☒ Action due dates are according to local and global metrics. Target is less than 180 days through
implementation.
☒ CAPAs with due date over 365 days have appropriate approval in Windchill.
☒ A statistical rationale is provided for sampling in VoE Plan. Source of statistical plan used was
included.
☒ A statistical rationale is provided for VoE duration.
☒ Acceptance criteria specifies the conditions under which the CAPA will be considered effective.
☒ Interim monitoring is documented or justified if not required.
☒ Monitoring required for adverse effects is documented and justified.