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Facing an audit Boon or Bane


Scout (a pilot car!) Scout is the man ahead of the auditor. He is the signal ... Auditor is new to your process, keep brief presentations ready. Process flow ... – PowerPoint PPT presentation

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Title: Facing an audit Boon or Bane

Facing an audit Boon or Bane?
  • R Raghunandanan
  • Pharma Consultant
  • Mumbai
  • IPA Mumbai 24th May 2008

  • Introduction
  • Pre-audit preparations
  • During audit process
  • Post-audit preparations
  • Dos and Donts

  • What audits we face
  • Regulatory audits
  • Customer audits
  • Internal audits
  • Other audits like ISO, HSE etc.

  • 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.)

  • 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

  • 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

  • Why audits
  • Other audits
  • Specific business requirements
  • Pre-certification audits
  • Certification maintenance audits
  • (Examples ISO 9001, ISO 14001, OHSAS 18001

  • Benefits of successful audits
  • New business opportunities
  • Business continuity
  • Market leadership advantages
  • Easier and faster regulatory approvals

  • 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

Internal audit Vs External audit
  • Internal audit focused on internal quality
  • 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!

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

Basic preparations
  • Are we audit ready ? Everyday ?
  • Ideally Should be !
  • Theoretically Yes !!
  • Practically No!!!

Preparations to face the audit
  • Four stages
  • 1. Preaudit
  • 2. During the Audit
  • 3. Post audit
  • 4. Also ongoing or audit specific

Pre audit preparations
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

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)

Team selection
  • People decide the fate of the audit (at least
  • Pick up the right people
  • Knowledgeable
  • Competent
  • Confident
  • Honest
  • Credible
  • Good communication skills

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

The working team
  • Inspection readiness team
  • Form it in advance
  • Members from QA, QC, Mfg, Eng, RD, Regulatory,
    HR, Warehouse
  • Meet periodically
  • Review the preparations
  • Take remedial / corrective actions for issues

The winning team
  • Inspection management team
  • Senior management team
  • Form it in advance
  • Senior managers from QA, QC, Mfg, Eng, RD,
    Regulatory, HR
  • Meet periodically
  • Review actions by Inspection readiness team
  • Give directions and exercise controls

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

Control Room Leader
  • A senior person from any department
  • Has to handle all documents
  • High level of alertness
  • Ability to manage multi document requests
  • Good man manager

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

Scribes (note takers)
  • Silent listeners of all that is spoken by the
  • 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

  • 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

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

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

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!

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

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

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

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

Auditors hotspots
  • Auditors look for areas where patient risk is
  • Deviations
  • Change control
  • OOS results
  • Customer complaints
  • Adverse events
  • Laboratory controls
  • Validation
  • Risk management

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
  • Validation
  • Maintenance and calibration
  • Rehearse on these in advance

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)

During audit
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

  • 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.

  • 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

Sequence - his choice
  • May vary from audit to audit or auditor to
  • May start with review of last audit compliance
  • May start with CAPA review
  • May start with plant tour
  • Do not offer a sequence, let him suggest
  • Once agreed start off

Systems approach
  • Some auditors may follow systems approach for
  • Facility management
  • Equipment management
  • Material and Product controls
  • Packaging and labelling
  • Laboratory controls

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

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
  • Special attention to some specific processes like
  • Aseptic operations
  • API final bagging
  • Sterility testing
  • Auditors may spend long time at these processes

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

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

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

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

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

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!!

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

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

How to handle an unannounced audit ?
  • The answer is only one

Be in a state of inspection readiness always !!
Post audit
Post mortem?
  • Do an after action review (AAR)
  • What went well
  • What did not go well
  • What could be done better for future

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

Responding to report
  • Response should go from a senior manager
  • Start with thanking the auditor
  • Reassure your commitments to ensure quality and
  • Your plans for closing the observations
  • Point wise responses
  • Provide examples if required how a point will be
  • Provide clear dates of completion

Some Dos and Donts
Take the bull by the horns?
  • Do not confront
  • You will not win
  • So win him over to your side

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
  • Inspector does not expect you to answer
  • Do not spoil the show
  • Not acceptable words

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

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

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

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

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

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

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

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

You learn from experience You learn better from
bad experience
Thank You and Good Luck
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