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FDA GMP Training:

The Quality Audit

Compliance Insight, Inc.

5850 Boymel Drive, Suite 1
Fairfield, OH 45014
Terms and Definitions
An estimate or determination of the significance,
importance or value of something
A planned,independent and documented assessment to
determine whether agreed upon requirements are met
An affirmative indication or judgment that the supplier
of a product or service has met requirements
Terms and Definitions
An affirmative indication or judgment that a product
or service has met the requirements of the specs or
A conclusion of importance based upon observations
An item of objective evidence found during an audit
Terms 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
Purpose of an Audit
To examine the effectiveness of management
directed control programs (or lack of
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
Audit Philosophy
Quality Audits are
formal, systematic and
Based upon facts
Auditors must be fact
finders (not fault finders)
Audits should not be
conducted in a covert
Types of Audits
Product Audit

Process Audit

System Audit
Type of Audits
concentrate on one or more products or services
concentrates on the results achieved as a result of
the process
focusis on the overall quality systems which result
in management directed activities and programs
Auditor Skills and Conduct
Important to success of audit
Continuation of services
Correcting problems
Finding problems
Skill development takes time (usually years)
and dedication
will always be learning and adapting to new
dress to present a competent and favorable impression
dont be late or excessively early
plan and prepare - safety, trade secrets, union policies
bewilling to make allowances for infrequent, insignificant
human error
Remain calm
dont over-react
watch your demeanor
dont incite nor
can nullify the audit
Polite and courteous
considerate and helpful
please and thank you
Direct and concise
askquestions clearly
make statements clearly
may have to take time out to formulate response
Recognize effort
seethat activities are on-going to correct
make note in report
Auditor Characteristics
Has to be developed and maintained
formal training
technical language skills
verbal and written
exposure to various processes and equipment
assist in other audits
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
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
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 auditors responsibility to be clear and
understood with the messages sent
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.)
Often lack technical expertise
Regional dialects are also frequent barriers
Communication (cont.)
communication is very
important, an equally
(perhaps even more
important) and often
overlooked skill is
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
Sends a very poor message
Listening (cond)
Information overload
Thinking about the last
response or the next
Since a person can hear
over 3x faster than one
speaks in average
conversation, it is very easy
for the listeners mind to
Listening (cond)

Good listening takes

practice and
Paraphrasing is a good
technique to test your
level of comprehension
and concentration
Listening (cond)

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
Listening (cond)
Insensitive listeners
Do not pay attention to non-verbals being
communicated and may not receive the entire
message clearly
Communication hogs
Talkconstantly and say little, often repeating
Often dont comprehend returned responses
when they stop to come up for air.
Listening (cond)
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 youre saying is
common knowledge or redundant
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
Requires attention to detail
Analytical thought substantiated with objective evidence
receiving messages
have an inquisitive outlook
notice the obvious and the obscure

Need ability to connect the dots or draw the

observations together
Pertains to the facts as they are presented or
found during the audit
Ones personal bias and opinions must not
be an influencing factor
Auditor must have the ability to overcome
personal beliefs and preconceived value
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
Dont draw a conclusion until all the facts are in
Auditor Problems
Come to the dark side, Luke
- Darth Vader
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
Time 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
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)
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
Afteran unfavorable audit, financial allotments, and
other support often become suddenly available to the
responsible individual being audited.

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
One of the oldest
games in the book
Usually occurs when a
big contract is at stake
Often does not involve
the presentation of
Bribery (cond)
Usually involves the auditee befriending the
auditor and involves outside hours
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
Tactics Chart
Auditee Tactic Auditor Response
Verify availability of needed documents and then
provide a reminder
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.
Go to head auditee contact and ask for substitute
Sympathy Ignore it. Proceed with audit.
Tactics Chart (cond)
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 Take notes. Confirm facts. See if auditee keeps their
Circumstances facts straight
Advise auditee that if progress remains slow, you will
Time Wasting
need to extend the audit.
Do It My Way, You Twit!
Ego trip for auditor
Rules by intimidation
Blasts the auditees self esteem

Remember the auditee is ultimately

responsible for implementing corrective
DIMWYT tends to be counter-productive
Auditor 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
External audits
Audit Ethics
Any auditor must
remove themself from
any upcoming audit
that may be
considered a conflict
of interest
Previous employer,
Personal friendship
Monetary involvement
Audit Ethics (cond)
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
Audit Ethics (cond)
The auditor group has
the responsibility to
support the audit team
and respect the
authority and
professionalism of
their auditors.
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