An Inspector Calls

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