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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
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
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
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.
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
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
Types of AuditsTypes of Audits
•Product Audit
•Process Audit
•System Audit
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
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!!!
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
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”
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
Auditor CharacteristicsAuditor Characteristics
Competence
Communication
Listening
Independence
Observation
Objectivity
Judging
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
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
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
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
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
Communication (cont.)Communication (cont.)
Although
communication is very
important, an equally
(perhaps even more
important) and often
overlooked skill is
LISTENING
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
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
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
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
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.
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
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
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
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
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
Auditor ProblemsAuditor Problems
“Come to the dark side, Luke”
- Darth Vader
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
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
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)
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.
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
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
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
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.
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.
““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
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
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
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
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.
For more help in yourFor more help in your
training…training…
Contact us at:
513-860-3512
www.Compliance-Insight.com
Free consultation via phone
info@compliance-insight.com

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FDA GMP Training - The 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
  • 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.
  • 45. For more help in yourFor more help in your training…training… Contact us at: 513-860-3512 www.Compliance-Insight.com Free consultation via phone info@compliance-insight.com