The document outlines a panel discussion script on pre-approval inspection (PAI), focusing on preparation, execution, and response strategies for inspections. It details the importance of planning, key activities for preparation, and how to manage the inspection day effectively, including communication and logistics. Additionally, it emphasizes post-inspection response processes and maintaining inspection readiness with quality assurance oversight.

29. PAI: Pre‐Approval Inspection Presentation
Panel Discussion Script
In discussing prep and execution for a PAI inspection, we typically organize our preparation activity into four main areas:
Plan, Prepare, Execution, and Response & Maintenance.
Phase Questions Talking Points (Answers)
Planning:
Initial Question: Looking back on your efforts to  Published guidance docs (7346); Field guides; experienced
plan for your recent PAI, can you team members (Pink Sheet, Gray Sheet, Gold sheet)
give us some insight into when you  High Level Project Plan
really start thinking, “we need to  Defining Key Elements of a Successful Inspection
plan for an inspection”, and what
did that plan look like?
Follow Up Questions  How did you know what to
prepare for?
o Established
publications
o Poll the experts
o Current Industry
Trends
 Once you had a plan, how did
you get support internally and
convince management that it
was worthwhile to dedicate
the necessary resources?
Preparation:
Initial Question: So, now you’ve got a good plan and Long Term
it’s time to get ready. What were  Gap Assessment
the key activities you performed to  Gap Remediation
prepare for the inspection?  Self‐Inspections (Audits)
 Mock Inspection
 Identify & Commission the Inspection Readiness Team
Short Term (~ Few months prior)
Short Term:  Define the tour route
With the inspection just a few short  Stage “obvious” documents
weeks away, I imagine you shifted  Request information from inspectors (E.g., agenda)
to “final preparation” mode. Tell  Final practice sessions
the group about how you changed
 Facility “beautification”
your mindset during that time, and
 Readiness “walkthroughs”
what some of your final prep
 Inspection Logistics
activities were.
 Rehearsing “final team” assignments, and simulation
 Getting technology ready, making sure it worked.
 Office supplies, Food, etc.
Follow Up Questions 1. How did you monitor progress 1. Regular meetings; frequency increasing as inspection
on closing gaps identified? drew closer.
2. What were key lessons 2. Presenters, communication lines, Tour planning, etc.
learned in the Mock 3. Planned for specific individuals to be in the inspection
Inspection? room; most issues handled by inspection team; ability to
3. How did you select individuals communicate effectively
to present? 4. Sr. Mgmt actively involved; supported inspection

30. PAI: Pre‐Approval Inspection Presentation
Panel Discussion Script
4. How involved was Senior preparation activities; ensured participation by key
Management in the people
preparation activities?
5. How did you handle resolving
differences of opinion?
Execution:
Initial Question: So, you’ve done all this time  Followed our plan
preparing – now it is “the day of”. o Opening presentation
Did it all the planning pay off?  Build rapport with inspectors
 Used presentation to set stage
How did you facilitate the  Recommended that we provide a technical
inspection? presentation, for their benefit.
o Followed planned tour route
 Educate, show off facilitate
o Adjusted as needed per inspector requests
 Execute Logistics Plan
o Communication between control room, and
inspection room; records retrieval, presenter prep
o Make it look seamless to the inspectors
o Know your contingency plans
Follow Up Questions How did you prepare for the Know what you have (and don’t have), know what your gaps
unexpected? I.e., did you plan a and weaknesses are; and prepare a defense strategy for those.
response if you didn’t have a good
answer to a question? Fall back on procedures, when all else fails.
Response & Maintenance:
Initial Question: Tell us a little bit about the process Know what the response timeline is.
to respond, and how you managed Don’t react, but develop responses that you can commit
that work effort? to and achieve.
 Get your questions answered, but don’t be
argumentative.
 Identify the correct parties to develop the responses.
 Get cross‐functional review and approval.
 Track commitments to completion.
Follow Up Questions How do you maintain your state of Ensure accountability of the functions, with QA Oversight.
inspection readiness?