1. An Inspector Calls

2. Agenda  An Inspector is………………  What an Inspector has to do  How the Inspector inspects  Management of an Inspection  Your Role – The Interview / behaviour  Questions

3. An inspector is …………………  A human being, good and not so good points  Very knowledgeable  Got a job to do  An individual/different styles – personalities Gets tired – just like we do!

4. What an inspector has to do  Enforce Regulatory requirements  Has to assess Company Compliance/Control  Has to produce reports  Ensure follow-up corrective/preventative actions A tough job!

5. How an Inspector inspects  This is a snap-shot in time  Review documentation/training  Interrogate validated systems  Walk about and chat  Interview with staff at all levels Documentation, Documentation, Documentation – If it is not documented, it has not been done!

6. Management of an Inspection  We check we are doing everything OK (Follow company SOP on preparation for Regulatory inspection)  Mock inspections  Train everyone that might be involved  Organise the whole thing – the Control Room!  We act as a team not a set of individuals And keep calm and collected!

7. Your Role  It’s like a test of the system of which you are a part – revise well  Know the legislation and guidelines/ Where is it?  Know your Policies, SOP’s/WIs-/ Where are they?  Know what you do and exactly how you do it – if not sure refer to relevant SOP and WIs  Make sure you have been trained/training records  If not, ask your manager – NOW! Prepare for success – or be prepared to fail!

8. The interview/chat – Inspector  Should be relaxed/might not be!  Process of gaining information/confidence in you  Dig to find answers  Ask for help/demonstrations  Ask for evidence Will continue until answers obtained

9. The Interview/chat behaviour YOU MUST BE  Well Prepared – know your stuff – Know which SOPs/WIs apply, training file up to date  Confident, cool, calm, collected  Polite at all times – never aggressive  Helpful – but only reactively  Answer the questions truthfully and only the question asked  Act professionally BY THE WAY – it’s OK to not know – just say so!

10. The Interview/chat/behaviour - DON’T  Guess or say “I think” – you know it or you don’t  Lie! – it all ends in tears  Get aggressive or be ‘clever’  Fidget, shift around, touch your face etc  Volunteer anything not asked for – don’t elaborate on your answers  Chat in places the auditor may be ie. toilets, corridors etc Don’t lose it, hang in there We will be there to support/moderate

11. So Remember………… An Inspector is: a knowledgeable human being has a tough job to do interrogates documentation/systems/people And you : are well prepared, know your job Represent the company in the best possible way Behave professionally

12. An Inspector Calls THANK YOU AND GOOD LUCK