facing an audit i pa

7/30/2019 Facing an Audit i Pa

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Facing an audit

Boon or Bane?

R RaghunandananPharma Consultant

Mumbai

IPA Mumbai 24th

May 2008


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Agenda

Introduction

Pre-audit preparations

During audit process

Post-audit preparations

Dos and Donts


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Introduction

What audits we face

Regulatory audits

Customer audits

Internal audits

Other audits like ISO, H&SE etc.


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Introduction

Why audits

Regulatory audits

For assessing compliance status

For approving new facilities

For issuing mfg permissions

For renewing licenses, periodic visits

For investigations (recall, seriouscomplaints, counterfeits etc.)


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Introduction

Why audits

Customer audits

For due diligence

Assessing business feasibility

Assessing technical capabilities

Assessing facility status

Assessing system status Post audit follow up

Routine / periodic reviews


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Introduction

Why audits

Internal audit

Improvement audits

Compliance status

Sarbanes-Oxley audit

System audits (after certain events likerecall, adverse events)

Pre-regulatory audits

Corporate Quality audits


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Introduction

Why audits

Other audits

Specific business requirements

Pre-certification audits

Certification maintenance audits

(Examples ISO 9001, ISO 14001, OHSAS

18001 etc.)


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Introduction

Benefits of successful audits

New business opportunities

Business continuity Market leadership advantages

Easier and faster regulatory approvals


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Introduction

Audits help you

Identify your strengths

Identify your problem areas Get solutions

Get recognition

Keeping high employee morale

Audits are worth the time and money,always


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Internal audit Vs External audit

Internal audit focused on internal qualityimprovement

Internal auditors are there to help you

Regulators priority is not qualityimprovement, it is compliance assessment

Regulators first commitment is to patient

Regulators are enforcement agencies,assisting you to solve your problem is nottheir job!


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Basic preparations

Audit preparedness what is it?

It is more than just preparation!

It is a systematic stage wise exercise

Prepared well, prepared in time prepared to win!


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Basic preparations

Are we audit ready ? Everyday ?

Ideally Should be !

Theoretically Yes !!

Practically No!!!


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Do your home work systematically

Have an SOP for Inspection Preparedness

Senior management must own the process

Define responsibilities, who will do what Audit is an important business process

You have to sellyour company by

Clearly trumpeting your strengths

Expressing your willingness to improve


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Who help the audit run smooth

Identify and nominate

Inspection Readiness Team Leader (ideally a seniormember of QA)

Inspection Readiness Team

Host (or Spokesman)

Control Room In-charge

Subject Matter Experts (SME)

Scribe (Note takers)

Escorts Runners (Messengers)

Scout (a pilot car equivalent)


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Team selection

People decide the fate of the audit (at least50%)

Pick up the right people

Knowledgeable

Competent

Confident

Honest

Credible

Good communication skills


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The man at the helm

Inspection Readiness Team Leader

Carefully choose him/her

A go-getter QA senior

A self motivator

Good knowledge of all site processes

Good control over the site CAPA process

Good man management skills


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The working team

Inspection readiness team

Form it in advance

Members from QA, QC, Mfg, Eng, R&D,Regulatory, HR, Warehouse

Meet periodically

Review the preparations

Take remedial / corrective actions forissues identified


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The winning team

Inspection management team

Senior management team

Form it in advance

Senior managers from QA, QC, Mfg, Eng,R&D, Regulatory, HR

Meet periodically

Review actions by Inspection readinessteam

Give directions and exercise controls


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Control Room Leader

A senior person from any department

Has to handle all documents

High level of alertness

Ability to manage multi document requestssimultaneously

Good man manager


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Subject Matter Experts (SMEs)

Host or senior managers may not be ableto answer all queries of auditors

SMEs are experts in their field

Must know all the processes in theirfunctions

Should have good presentation skills

Good command over the language


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Scribes (note takers)

Silent listeners of all that is spoken by theauditors

Writes down

what inspectors are asking what comments they are making

whom they have spoken with

what inspectors have seen or observed

Should have good skills to listen and observe Should have good computer skills

Patient and good communicator


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Escorts

Will be with the auditors all the time

Usually senior managers

Preferably one who has auditing experience

Accompanies the auditors on site tour Does not involve in discussions with the

auditor and the dept manager

Should be able to defuse a difficult situation


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Runners (messengers)

They are communicators

Takes messages from escorts, deptmanagers to control room or SMEs

Passive in inspection

Active in their job

Much of the audit success lies in getting the

documents in time Select those with good interpersonal

relations, smart and fast


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Scout (a pilot car!)

Scout is the man ahead of the auditor

He is the signal for the host dept

Helps in letting you know where the

inspector is

Passive in inspection

Alert in their job

Auditor may change the route or even go backto the last dept


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Inspection room (the battlefield!)

Meeting room

Quiet, comfortable

Necessary infrastructure like LCD projectors,

white boards, flip charts, markers Telephone facilities

Food, water and beverage arrangements toauditors liking

Garment, footwear, headwear, helmet,mask, umbrella size and quality bothmatters!


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External arrangements

Accommodation

Location, comfort, meeting their standards(ideal to check in advance)

Transport arrangements Airport / railway station pick-up

Pick-up and drop during audit days

Car safety, seat belts etc.

Stand by car and guide


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Control room

Document management room (war room!)

Close to inspection room

Adequately spaced

Documents segregated dept wise Easily accessible to check, provide and

retrieve

Visibility of what is asked for, what is givenand what is received back

Controlled access, train the staff


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Run a mock inspection

By senior managers from differentsites/areas Simulate the process

Follow the SOP

Identify improvement areas

Take corrective actions

Retrain people

Any amount of preparation is not a waste


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Collect prior information

Get to know details of the auditor inadvance

Name Title, spelling, pronunciation

Background, specialization, industry exposure Nature Tough, resistant, understanding,

egoistic, easy going

Recent industry experiences


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Keep your information ready

Auditor is new to your process, keep briefpresentations ready Process flow

Major quality processes

Deviation management

Change control

Complaint handling

OOS, APQR

Validation Maintenance and calibration

Rehearse on these in advance


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Prepare yourself

Do health check on

Calibration status and status labelling

Warehouse segregation and status labelling

SOP validity Updating of complaint logs

Reference substances data

Staff training records

Cleanliness and hygiene (must be a priorityalways, not just for audit)


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Arrival on the Dday

First impression matters

Housekeeping top priority

Organized reception at gate by security

Inform company policy on match box, lighters,cell phone, camera

Entry passes as per policy

Safety and evacuation procedures card


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Beginning

Host takes charge now Check if the auditor wants to make a presentation

or give a plan for the day

Check if you can make a brief presentation about

the company and business Be brief (not more than 5 to 7 minutes)

Keep a presentation on Quality philosophy readyto be made if asked

Keep a presentation on the process flow ready


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Sequence - his choice

May vary from audit to audit or auditor toauditor May start with review of last audit compliance

report

May start with CAPA review

May start with plant tour

Do not offer a sequence, let him suggest

Once agreed start off


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Out on plant / lab tour

Escorts must accompany all the time Scout walks ahead

Scribes behind

Dept manager at the dept

Dept manager shall respond to questions

Escort butt in only in an eventuality

Answer only what is asked

Do not volunteer more than what is asked for

Be frank, if you dont know say so, offer anotherexpert (SME) to answer on your behalf

Never, never, never lie to an auditor


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Auditor will look at the process & practices

Will ask questions to staff

Tally the process and practices with SOPs

Will look for unauthorized copies of SOPs

Lab is very vulnerable area for Unofficial records

Scribbling pads, discarded chromatograms etc.

May ask same question to different staff to validate theanswer

Allow dept staff to answer

Escort intervenes only if communication collapses


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When auditor is on his job Scribe notes down everything that happens

Scribe takes note of any document auditor wantsto see on site or back in inspection room

Runners on job to get whatever is asked

Escort and dept manager Should observe everything

Look where the auditor is looking

See what the auditor is seeing Listen to what he is commenting

Understand his body language


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Back in inspection room

Discussion on what he observed

Involve SMEs to answer /present

If required call the dept manager to explain

Offer to revisit the site if desired to verify Document review

Most critical phase

provide only what is asked for

Experts to sanitize all that is provided Scribes play a major role now

Control room alertness at the peak now


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Coming to an end

Host should request for daily feedback

Limit the attendance

Clarify misunderstanding if any

Seek clarifications if any

Once recorded and with your node, its is not possible tochange

Offer to rectify minor issues before the end of the audit

Check on plan for the next day

Arrange for safe departure In case you have a dinner, confine to general topics,

nothing on your business/audit


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Site wash up meeting

Host should call for an in-house reviewmeeting at the end of each day

Include all those who were part of the audit

Review what went well Review what did not go well or as expected

Discuss and decide on damage control

Prepare for tomorrow

Inform everyone what is promised for tomorrow Do not forget to thank everyone!!


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How to handle a team?

Remember, there may be more than oneauditor

They may split and take different routes

Be equipped to handle the situation Two sets of people to be ready


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How to handle an unannounced audit ?

The answer is only one

Be in a state ofinspection readiness

always !!


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Post mortem?

Do an after action review (AAR)

What went well

What did not go well

What could be done better for future


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Responding to report

Response should go from a senior manager

Start with thanking the auditor

Reassure your commitments to ensure

quality and compliance Your plans for closing the observations

Point wise responses

Provide examples if required how a point will

be closed Provide clear dates of completion


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Choose your responses correctly

If I remember right ..

Means you are not sure

When you are in charge, you must be sure If you dont remember, ask another person to

answer

Inspector does not expect you to answer everything

Do not spoil the show Not acceptable words


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Normally it happens this way

Means this is not always what happens

There are abnormal things happening You dont want to commit

You will be coaxed to say what else happens

Not an acceptable answer


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Not us, another dept has done it

Remember you are not speaking to your boss

You are speaking to an auditor Do not play games here

Will show lack of inter-dept co-ordination



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To be really honest with you ..

OR

To tell you the truth

Means previously you were not so honest and true

Raises suspicion in the auditors mind

He may ask for replay !!

Do not break the trust you built in so far



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It is too expensive

The most negative answer to an auditor

Savings not at the cost of quality Suggest alternatives

Suggest phased implementation

He will be happy to see your commitment


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The language muddle

Never speak behind the auditor in a language notknown to him

If an operator is not able to understand the auditorslanguage, you should let him know first that you will

seek his response in the local language and thentranslate for him

Watch your body language too be polite, patient,attentive, respectful

Auditor is a human being, and he is helping you


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