fda gmp training - the quality audit
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How to conduct or survive a GMP Quality AuditTRANSCRIPT
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
AmnesiaVerify availability of needed documents and then provide a reminder
BribesRefuse and report them. Advise client firm to deal with others.
Cook's Tour Cut it short - stick to audit planExtended Lunch Auditors can eat alone. Ask for substitute escortGoobledy Gook "Interesting, but the audit is my primary concern."Insincerity Ignore it. Proceed with audit.Language Barrier Prepare in advance. Provide a translator.
No-ShowGo 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 ResponsePower 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 WastingAdvise 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.
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