An Inspector Calls

Agenda An Inspector is………………

What an Inspector has to do

How the Inspector inspects

Management of an Inspection

Your Role – The Interview / • behaviour

Questions

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!

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!

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 levelsDocumentation, Documentation,

Documentation – If it is not documented, it has not been

done!

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!

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!

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

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!

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 thereWe 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