How to conduct or survive a GMP Quality Audit

1. FDA GMP Training:FDA GMP Training:
The Quality AuditThe Quality Audit
Compliance Insight, Inc.
5850 Boymel Drive, Suite 1
Fairfield, OH 45014
513-860-3512

2. Terms and DefinitionsTerms and Definitions
Assessment
An estimate or determination of the significance,
importance or value of something
Audit
A planned, independent and documented assessment
to determine whether agreed upon requirements are
met
Compliance
An affirmative indication or judgment that the
supplier of a product or service has met requirements

3. Terms and DefinitionsTerms and Definitions
Conformance
An affirmative indication or judgment that a product
or service has met the requirements of the specs or
regulations
Finding
A conclusion of importance based upon observations
Observation
An item of objective evidence found during an audit

4. Terms and DefinitionsTerms and Definitions
Quality Audit
A systemic and
independent examination
and evaluation to determine
whether quality activities
and results comply with
planned arrangements and
whether these arrangements
are implemented
effectively and are suitable
to achieve objectives.

5. Purpose of an AuditPurpose of an Audit
To examine the effectiveness of
management directed control programs (or
lack of directive)
Provides management with objective
feedback based upon facts, enabling
management to make informed decisions
Primary directive of an audit is to be
beneficial to the function being audited

6. Audit PhilosophyAudit Philosophy
Quality Audits are
formal, systematic and
independent
Based upon facts
Auditors must be fact
finders (not fault finders)
Audits should not be
conducted in a covert
manner

7. Types of AuditsTypes of Audits
•Product Audit
•Process Audit
•System Audit

8. Type of AuditsType of Audits
Product
concentrate on one or more products or services
Process
concentrates on the results achieved as a result
of the process
System
focus is on the overall quality systems which
result in management directed activities and
programs

9. Auditor Skills and ConductAuditor Skills and Conduct
Important to success of audit
Continuation of services
Correcting problems
Finding problems
Skill development takes time (usually
years) and dedication
you will always be learning and adapting to
new ways!!!

10. ProfessionalismProfessionalism
Appearance
dress to present a competent and favorable impression
Punctuality
don’t be late or excessively early
Preparedness
plan and prepare - safety, trade secrets, union policies
Fairness
be willing to make allowances for infrequent,
insignificant human error

11. ProfessionalismProfessionalism
Remain calm
don’t over-react
watch your demeanor
don’t incite nor
participate
can nullify the audit
Polite and courteous
considerate and helpful
“please” and “thank you”

12. ProfessionalismProfessionalism
Direct and concise
ask questions clearly
make statements clearly
may have to take time out to formulate response
Recognize effort
see that activities are on-going to correct
observations
make note in report

13. Auditor CharacteristicsAuditor Characteristics
Competence
Communication
Listening
Independence
Observation
Objectivity
Judging

14. CompetenceCompetence
Has to be developed and maintained
formal training
experience
technical language skills
verbal and written
exposure to various processes and equipment
assist in other audits

15. CommunicationCommunication
Very complex process of sending and
receiving messages/data
Hidden messages that may be transmitted
include anger, confusion, apathy, boredom,
hostility, concern, contempt and fatigue
These hidden messages effect the
atmosphere positively or negatively
Will have a direct impact upon the audit

16. CommunicationCommunication
Ask the same question in a different way if
you suspect something/or want to verify
How do you clean the equipment?
Ask open ended questions
When you clean the equipment, you dismantle
part A and then part B - Right?
Ask other people not immediately present when
the previous answers were given.
Ask the same question the next day.
Ask to be shown how to clean the equipment
Verify what was conveyed to you with the SOP

17. Communication (cont.)Communication (cont.)
Hidden messages can be intentional or not
body movements
facial expressions
vocal intonations
Once a message is received (intentional or
not), it is impossible to “unreceive” it
It is the auditor’s responsibility to be clear
and understood with the messages sent

18. Communication (cont.)Communication (cont.)
International obstacles
Different cultures (Japanese often nod when
someone else speaks. This should NOT be
interpreted as agreement. This is only an
acknowledgment that you are speaking. They
may not have any idea what you are saying.)
Interpreters
Often lack technical expertise
Regional dialects are also frequent barriers

19. Communication (cont.)Communication (cont.)
Although
communication is very
important, an equally
(perhaps even more
important) and often
overlooked skill is
LISTENING

20. ListeningListening
Not only to what is being said but also what
is NOT being said
Necessary to filter “external noise” from
unfamiliar surroundings and activities
Excess “external noise” may lead to lack of
concentration, the loss of a thought, misplaced
documents.
Sends a very poor message

21. Listening (con’d)Listening (con’d)
Non-listening
Information overload
Thinking about the last
response or the next
question
Since a person can hear
over 3x faster than one
speaks in average
conversation, it is very easy
for the listener’s mind to
wander

22. Listening (con’d)Listening (con’d)
Good listening takes
practice and
concentration
Paraphrasing is a good
technique to test your
level of comprehension
and concentration

23. Listening (con’d)Listening (con’d)
Four Types of non-listening behavior
Defensive Listeners
Listen beyond what is being said and often
“reads” more into what is being said than what
is spoken
Often take offense when none was intended

24. Listening (con’d)Listening (con’d)
Insensitive listeners
Do not pay attention to non-verbals being
communicated and may not receive the entire
message clearly
Communication hogs
Talk constantly and say little, often repeating
themselves.
Often don’t comprehend returned responses
when they stop to come up for air.

25. Listening (con’d)Listening (con’d)
Pseudo listeners
May exhibit appropriate listening cues
(nodding, or “uh-huh”) but are not really
paying attention
Often indicates the listener is bored,
preoccupied, or believes what you’re saying is
common knowledge or redundant

26. IndependenceIndependence
Auditors should not hold bias toward the
department, operation or system which is being
audited
Should be NO monetary involvement or prior
personal involvement
Should have no influence from management
Auditors should have freedom and trust to report
audit findings with the knowledge that
management will support the findings

27. ObservationObservation
Requires attention to detail
Analytical thought substantiated with objective
evidence
Includes:
receiving messages
have an inquisitive outlook
notice the obvious and the obscure
Need ability to “connect the dots” or draw the
observations together

28. ObjectivityObjectivity
Pertains to the facts as they are presented or
found during the audit
One’s personal bias and opinions must not
be an influencing factor
Auditor must have the ability to overcome
personal beliefs and preconceived value
judgments

29. JudgingJudging
What interpretation of documents is correct?
Do you need clarification?
Is an observation outside the scope of the audit?
Is it worthwhile to include?
Is the level of compliance acceptable?
Is the audit progressing as planned?
Judging requires you to be open minded and
aware of your own filtering system
Don’t draw a conclusion until all the facts are in

30. Auditor ProblemsAuditor Problems
“Come to the dark side, Luke”
- Darth Vader

31. AntagonismAntagonism
Must be prepared to encounter it and prevent it
May be an attempt to end or nullify the audit
It is crucial that you remain firm in the audit
purpose and objective without engaging in
argument
Reassure the auditee that the audit is for the
benefit of both parties
Explain the purpose of the audit at the start, this
will often prevent problems

32. Time EatersTime Eaters
Auditee is talkative or long winded
usually about subjects not pertinent to the audit
Long lunches
Waiting for data to be gathered
Inform auditee of time frame
Keep on track
Ask for data to be pulled ahead of time

33. EvasivenessEvasiveness
Usually one of two categories
does not have the information
does not want to reveal the information
Evasive answers should be a red flag
You have to listen carefully - pick out pertinent info or
key elements
Probe the response, continue to return to the original
question until it has been answered
Restate your understanding of the response (without the
superfluous info)

34. SympathySympathy
Human relations may interfer with the outcome
Any question of integrity impropriaty will
undermine the effectiveness of the audit
Although the auditee may be someone you can
empathize with, an objective audit is the best
“gift” you can give
After an unfavorable audit, financial allotments, and
other support often become suddenly available to the
responsible individual being audited.

35. GlossingGlossing
“Glossing” refers to the last minute Band-
Aid on a problem just before an audit
Glossing will not hide neglected issues
expecially of a serious nature
Of course, last minute housekeeping is
expected

36. BriberyBribery
One of the oldest
games in the book
Usually occurs when a
big contract is at stake
Often does not involve
the presentation of
cash

37. Bribery (con’d)Bribery (con’d)
Usually involves the auditee befriending the
auditor and involves outside hours
entertainment
wining and dining
sports game or concert
On the few occasions when a bribe,
especially money, is overtly offered, the
audit should be immediately terminated

38. Tactics ChartTactics Chart
Auditee Tactic Auditor Response
Amnesia
Verify availability of needed documents and then
provide a reminder
Bribes
Refuse and report them. Advise client firm to deal
with others.
Cook's Tour Cut it short - stick to audit plan
Extended Lunch Auditors can eat alone. Ask for substitute escort
Goobledy Gook "Interesting, but the audit is my primary concern."
Insincerity Ignore it. Proceed with audit.
Language Barrier Prepare in advance. Provide a translator.
No-Show
Go to head auditee contact and ask for substitute
escort
Sympathy Ignore it. Proceed with audit.

39. Tactics Chart (con’d)Tactics Chart (con’d)
Auditee Tactic Auditor Response
Power Play State facts. Be professional, but firm.
Provided Sample Refuse it. Take your own sample.
Provocation Keep composure. Remain professional.
Special
Circumstances
Take notes. Confirm facts. See if auditee keeps their
facts straight
Time Wasting
Advise auditee that if progress remains slow, you will
need to extend the audit.

40. ““DIMWYT”DIMWYT”
Do It My Way, You Twit!
Ego trip for auditor
Rules by intimidation
Blasts the auditee’s self esteem
Remember the auditee is ultimately
responsible for implementing corrective
actions
DIMWYT tends to be counter-productive

41. Auditor ResponsibilitiesAuditor Responsibilities
Keep client informed of the audit progress
Effectively lead audit team members
Support, intervene and resolve conflicts
Conduct a professional audit with a factual
report that benefits the auditee
Honor confidentialities of the auditee
Internal audits
External audits

42. Audit EthicsAudit Ethics
Any auditor must
remove themself from
any upcoming audit
that may be
considered a conflict
of interest
Previous employer,
Personal friendship
Monetary involvement

43. Audit Ethics (con’d)Audit Ethics (con’d)
The auditing group has
a responsibility to the
audit team to provide
adequate training of the
auditing function
Providing retraining to
hone skills
Keeping auditors up-to-
date with newest
recognized standards

44. Audit Ethics (con’d)Audit Ethics (con’d)
The auditor group has
the responsibility to
support the audit team
and respect the
authority and
professionalism of
their auditors.

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