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Facing an audit Boon or Bane

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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


1
Facing an audit Boon or Bane?
  • R Raghunandanan
  • Pharma Consultant
  • Mumbai
  • IPA Mumbai 24th May 2008

2
Agenda
  • Introduction
  • Pre-audit preparations
  • During audit process
  • Post-audit preparations
  • Dos and Donts

3
Introduction
  • What audits we face
  • Regulatory audits
  • Customer audits
  • Internal audits
  • Other audits like ISO, HSE etc.

4
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.)

5
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

6
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

7
Introduction
  • Why audits
  • Other audits
  • Specific business requirements
  • Pre-certification audits
  • Certification maintenance audits
  • (Examples ISO 9001, ISO 14001, OHSAS 18001
    etc.)

8
Introduction
  • Benefits of successful audits
  • New business opportunities
  • Business continuity
  • Market leadership advantages
  • Easier and faster regulatory approvals

9
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

10
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!

11
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!

12
Basic preparations
  • Are we audit ready ? Everyday ?
  • Ideally Should be !
  • Theoretically Yes !!
  • Practically No!!!

13
Preparations to face the audit
  • Four stages
  • 1. Preaudit
  • 2. During the Audit
  • 3. Post audit
  • 4. Also ongoing or audit specific

14
Pre audit preparations
15
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

16
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)

17
Team selection
  • People decide the fate of the audit (at least
    50)
  • Pick up the right people
  • Knowledgeable
  • Competent
  • Confident
  • Honest
  • Credible
  • Good communication skills

18
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

19
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
    identified

20
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

21
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

22
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

23
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

24
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

25
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

26
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

27
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

28
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!

29
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

30
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

31
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

32
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

33
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

34
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

35
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)

36
During audit
37
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

38
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.

39
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

40
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

41
Systems approach
  • Some auditors may follow systems approach for
    auditing
  • Facility management
  • Equipment management
  • Material and Product controls
  • Packaging and labelling
  • Laboratory controls

42
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

43
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

44
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

45
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

46
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

47
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

48
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

49
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!!

50
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

51
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

52
How to handle an unannounced audit ?
  • The answer is only one

Be in a state of inspection readiness always !!
53
Post audit
54
Post mortem?
  • Do an after action review (AAR)
  • What went well
  • What did not go well
  • What could be done better for future

55
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

56
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

57
Some Dos and Donts
58
Take the bull by the horns?
  • Do not confront
  • You will not win
  • So win him over to your side

59
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

60
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

61
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

62
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

63
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

64
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

65
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

66
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

67
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

68
You learn from experience You learn better from
bad experience
69
Thank You and Good Luck
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