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Demonstrate Your
Quality Management System
During Inspection
Obaid Ali, R.Ph., Ph.D.
30 Sep 2023
First & Last
• Welcome Question
• Be simple & clear
• Speak truth
• Be confident
• Respond but never argue
• I will get back to you
First & Last
• I think …
• I am not sure …
• Usually …
• As per my opinion …
• Generally …
• Don’t confuse
Assign Duties
• Who will do what
• Make a plan
• Keep flexibility
• Make second choice open
Try to Practice
• Listen the questions
• Let him complete
• Don’t respond during question
• Ask for repetition if it is not clear
• Don’t share voluntarily
• Enjoy the silence of inspector
• Don’t lose courtesy and
professionalism
Try to Practice
• Opening & closing meeting
• Invite leadership in opening &
closing meetings
• Keep track of conversation
• Cooperation is key
• Don’t mislead
• “We will fix that”
Remember
• It is a business activity
• Conduct mock inspection
• Recognize areas of potential
concern
• Understand each other
• Be ready for inspection every day

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Demonstrate your QMS during Inspection-30 Sep 2023.pdf

  • 1. Demonstrate Your Quality Management System During Inspection Obaid Ali, R.Ph., Ph.D. 30 Sep 2023
  • 2.
  • 3. First & Last • Welcome Question • Be simple & clear • Speak truth • Be confident • Respond but never argue • I will get back to you
  • 4. First & Last • I think … • I am not sure … • Usually … • As per my opinion … • Generally … • Don’t confuse
  • 5. Assign Duties • Who will do what • Make a plan • Keep flexibility • Make second choice open
  • 6. Try to Practice • Listen the questions • Let him complete • Don’t respond during question • Ask for repetition if it is not clear • Don’t share voluntarily • Enjoy the silence of inspector • Don’t lose courtesy and professionalism
  • 7. Try to Practice • Opening & closing meeting • Invite leadership in opening & closing meetings • Keep track of conversation • Cooperation is key • Don’t mislead • “We will fix that”
  • 8. Remember • It is a business activity • Conduct mock inspection • Recognize areas of potential concern • Understand each other • Be ready for inspection every day