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