fda gmp training - the quality audit

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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