Facing an audit

Boon or Bane?
R Raghunandanan Pharma 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, serious complaints, counterfeits etc.)

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Introduction
Why audits
Customer audits

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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 like recall, 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 quality improvement Internal auditors are there to help you Regulators priority is not quality improvement, it is compliance assessment Regulators first commitment is to patient Regulators are enforcement agencies, assisting you to solve your problem is not their 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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Preparations to face the audit

Four stages 1. Preaudit 2. During the Audit 3. Post audit 4. Also ongoing or audit specific
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Pre audit preparations

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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 sell your 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 senior member 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
50%) (at least

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 for issues 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 readiness team Give directions and exercise controls
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Host or Spokesman
Site Head or Senior QA Head First contact for auditors Projects the company Makes the opening presentation Puts the auditors at ease Promises all support Symbolizes company to the auditor

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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 requests simultaneously Good man manager

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Subject Matter Experts (SMEs)

Host or senior managers may not be able to answer all queries of auditors SMEs are experts in their field Must know all the processes in their functions 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 the auditors 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, dept managers 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 back to 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 to auditors liking Garment, footwear, headwear, helmet, mask, umbrella size and quality both matters!
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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 given and what is received back

Controlled access, train the staff

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Run a mock inspection

By senior managers from different sites/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 in advance
Name Title, spelling, pronunciation Background, specialization, industry exposure Nature Tough, resistant, understanding, egoistic, easy going Recent industry experiences

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Auditors hotspots
Auditors look for areas where patient risk is highest
Deviations Change control OOS results Customer complaints Adverse events Laboratory controls Validation Risk management
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Keep your information ready

Auditor is new to your process, keep brief presentations 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 priority always, not just for audit)
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During 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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Reception
Senior Managers must
Meet the auditor when he comes in Greet him (flowers not preferred) Offer welcome drinks (no wines please!) Spend few minutes (not more than 5 min) No photos, no videos Inform him about wash rooms, lunch break, tea and beverages availability etc.

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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 ready to 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 to auditor
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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Systems approach
Some auditors may follow systems approach for auditing
Facility management Equipment management Material and Product controls Packaging and labelling Laboratory controls

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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 another expert (SME) to answer on your behalf Never, never, never lie to an auditor
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Out on plant / lab tour

Never make exceptions for the auditor Remember the audit is not just a facility audit, it is a process audit too Plant / lab activities must run as usual People should not be hanging around without activity Special attention to some specific processes like
Aseptic operations API final bagging Sterility testing Auditors may spend long time at these processes

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Out on plant / lab tour

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 the answer Allow dept staff to answer Escort intervenes only if communication collapses

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Out on plant / lab tour

When auditor is on his job
Scribe notes down everything that happens Scribe takes note of any document auditor wants to 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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Back in inspection room

Document clarifications
Involve SMEs Time taken to provide documents is crucial Anticipate what is coming next (scribes) Communicate to control room Through slips Through sametime chats (scribes) Control room should know what is happening in the inspection room

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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 to change 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 review meeting 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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Secrets of the trade

Be balanced during the whole audit Be confident while answering Do not challenge, politely disagree if you are very sure You should know when to retract

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How to handle a team?

Remember, there may be more than one auditor 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 of inspection readiness always !!

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Post audit
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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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Still a lot to do
While awaiting for the report Update senior management on outcome Anticipate any major consequences Consider alternatives for just in case Action the obvious non-conformances Start working on CAPA Summarize all observations by all participants and make a learning folder Share the learning within the site and other sister sites
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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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Some Dos and Donts

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Take the bull by the horns?

Do not confront You will not win So win him over to your side

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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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Choose your responses correctly

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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Choose your responses correctly

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 Not an acceptable answer

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Choose your responses correctly

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 Not an acceptable answer

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Choose your responses correctly

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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Be wary of the Long silence technique

Auditor asks you a question You answer Auditor listens Auditor maintains a long silence (purposely) You become anxious to break the silence You add more to the answers (mostly unwanted!) Auditor got enough to grill you! Dont be over anxious to break the silence, answer only to the point, not a word more
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The language muddle

Never speak behind the auditor in a language not known to him If an operator is not able to understand the auditors language, you should let him know first that you will seek his response in the local language and then translate 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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Unofficial is also official

Never speak any so called unofficial thing with the auditor There is nothing unofficial for an auditor when he is at your site, everything he sees and hears is official

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Cultural differences
Understand auditors cultural background There is no bar on religion, caste, region and language between auditor and auditee Both are professionals Both are inter-dependent Both are doing their jobs Create a win-win situation

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You learn from experience You learn better from bad experience

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