An Inspector Calls Agenda An Inspector is What

An Inspector Calls

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

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

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

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

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

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

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

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

The Interview/chat/behaviour - DON’T Ø Guess or say “I think” – you know it or you don’t Ø Lie! – it all ends in tears Ø Get aggressive or be ‘clever’ Ø Fidget, shift around, touch your face etc Ø Volunteer anything not asked for – don’t elaborate on your answers Ø 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

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

An Inspector Calls THANK YOU AND GOOD LUCK