Post on 28-Dec-2015
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