ASEAN Guidelines on GMP for Traditional Medicines - Philosophy of Inspection

PHILOSOPHY OF GMP INSPECTION
Malaysia
 
1
Legal Terms
2
 
Right to be heard
: No person shall be condemned,
punished or have any property or legal right
compromised by a court of law or authority action
without having heard that person.
Suspensive effective
: The postponement of the
execution of a decision pending the outcome of an
appeal.
Decision: 
A judgment, decree, or determination of
findings of fact and/or of law by a judge, arbitrator,
court, governmental agency, or other official court.
Advance notice: 
Informs the addressee about the
decision that will be taken to guarantee the
addressee
s right to be heard.
Legal Terms
Most auditors would be familiar
with the following requirements:
Authorized user log-on for a specific application
A unique password called for the CS, linked to the
authorized account for a specific application
Permitted task functionality for that user
Common time and standard referencing and transaction
linking
Time stamped audit trail
System information security
Where electronic signatures are required,
the following must be controlled :
Audit trail requirements:
The system should record the identity of operators
entering or confirming critical data.
Any alteration to an entry of critical data should be
authorized and recorded with the reason for the
change.
Consideration should be given to building into the
system the creation of a complete record of all
entries and amendments (an 
audit trail
).
Any alteration made to the entry on a document
should be signed and dated.
The alteration should permit the reading of the
original information.
Where appropriate, the reason for the alteration
should be recorded.
Audit trail requirements:
To independently record:
the date and time of operator entries
creations, modifications, or deletions of electronic
records
to verify that record changes do not obscure
previously recorded information.
Audit trail
s function:
Audit trail must be:
The Attributes of an Inspector
Remember that in an AUDITTING….
Unlimited number of possible 
scenarios
Is a systematic approach
Involves interpersonal skills
Identifies deficiencies
Look at what went wrong
Requires participation from both parties
Good Inspection Skills
The Attributes of an Inspector
We must respect the 
codes of ethics 
and 
conduct
;
Keep objectivity, impartiality, 
confidentiality
Mandatory good diplomat
Quality System mandatory for all inspectorates ?
The Attributes of an Inspector
PI 002-3  25 September 2007
RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL
INSPECTORATES
3.
PURPOSE
The purpose of adopting a common standard of inspection
is 
to achieve consistency in auditing standards between
auditors 
and thus to
Facilitate mutual recognition 
and  confidence 
between
AUDITORS / INSPECTORATES
The Attributes of an Inspector
PI 002-3  25 September 2007
RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL
INSPECTORATES
The personnel 
of the auditing service, should 
be free
from any commercial, financial and other pressures
which might 
affect their judgment and freedom to
act.
Auditor should ensure that the persons or
organizations external to the audited organization
cannot influence the result of the audit. 
Rules for
deontology, ethics, conflict of interest and improper
influence should be clearly defined.
The Attributes of an Inspector
PI 002-3  25 September 2007
RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL
INSPECTORATES
When more than one auditor is involved in an audit, 
a
lead inspector should be appointed to coordinate
audit activities
. The audit report should normally be
prepared by the lead auditor and should be agreed by
all participating auditors.
Observations and/or data obtained in the course of the
audit should 
be recorded in a timely manner to
prevent loss of relevant information.
The Attributes of an Inspector
Technical Aspects
 
The auditor should have the skill to make 
professional
judgments 
based on Facts and Science
 as to the
conformity
 of the audited party with the requirements
of 
good practices 
and the relevant legislation /
guidelines and be able 
to make an appropriate risk
assessment.
The Attributes of an Inspector
Technical & Non – technical 
Aspects
The credibility of a auditing process will depend
to a large degree on the 
technical competence
and 
integrity of the auditor
 
but
The non-technical skills are equally important
to the final outcome.
Clothing
Dress accordingly &
Taking in account the country codes
Note: Important for women inspectors, given the
variability of custom clothing
The Attributes of an Inspector
Non-technical Aspects
The Attributes of an Inspector
Non-technical Aspects
Remember that as an inspector, we are obliged to
PREPARE
 
how you will
introduce yourself, the
interview & its purpose
ASSESS
 already available
info 
SPECIFY
 interview
objective
Always do your
homework: 
Perfect
Preparation Prevent
Poor Performance
Preparation
Flexibility
 & Set limits
Objectivity
Positive attitude
Integrity
Coherence
Good Organization Skills
Good Communication Skills
Language
Body language
Personality, Emotions, Culture
Note:  
Personality
 as a dynamic and organized set 
 
of characteristics
possessed by a person that uniquely influences his or her
cognitions, motivations, and behaviors in various situations.  The
word 
personality
 originates from Latin 
persona
, which means
mask.
The Attributes of an Inspector
Non-technical Aspects
Remember that we are obliged
to…….
Define 
objectives
Set 
priorities
Detect 
weaknesses
Detect 
inconsistencies
Check
 traceability
Manage bad conduct & 
conflicts
PLANNING AHEAD
Good Time
Management
Manage
people/processes
Creating links
Manage the situation
/ process /
Manage time
The Attributes of an Inspector
Non-technical Aspects
An audit process requires participation from
both parties – with questions followed by
answers that frequently, the response will
lead to the next question, so we must be a
good listener
The Attributes of an Inspector
Non-technical Aspects
A positive atmosphere makes inspections
much 
more easier for both parties
The Attributes of an Inspector
Non-technical Aspects
Asking Questions….
Open questions stating with:
What?
Why?
When?
Good questioning skills
Silence can be very powerful
The Attributes of an Inspector
Non-technical Aspects
How?
Where?
Who?
Good listening practices
Active listening & avoid misunderstanding 
or 
Passive listening and paying attention
Hear the person out & be patient
Show the person that you are listening & interested
Encourage the person to continue
e.g.  by facing the person repeat important information with
your own words wait for the confirmation
Be approachable
Try to understand the speaker
s points of view
The Attributes of an Inspector
Non-technical Aspects
At Meeting Do Not Include:
Subjective opinions
Irrelevant information
Ambiguous statement
Antagonistic statement
New deficiencies which are not previously
discussed!
Transparency
The Attributes of an Inspector
Non-technical Aspects
At Meeting:
Good communication & interpersonal skills
Inspector must lead
Concise presentation
Discussion
Know when to invite discussion and when to limit the
discussion
Mention good points before deficiencies
Treat challenges politely
Discuss and resolve conflicts
Admit if wrong
Don
t back down if convinced you are right
The Attributes of an Inspector
Non-technical Aspects
Should
 be aware of the auditor
s influence
Careful interfering in 
well
 coordinated  
process
/ systems
Avoid entering the role of a consultant
Tell what is wrong
Why it is wrong
But not how to change!
The Attributes of an Inspector
Non-technical Aspects
Disclosure of faults, deficiencies, discrepancies
How to say it
How to find the key to the understanding of the
other party
   
Good Interpersonal skills
The Attributes of an Inspector
Non-technical Aspects
Bad predisposition &
Prejudgment
Underestimate the
auditee
Excessively emotional
Hubris, Arrogance &
Truculence
Inexperience
Avoid & Control
The Attributes of an Inspector
Non-technical Aspects
Bad preparation of
inspection
Interest conflicts
Personal interpretation
of guidelines
Negligence;
opportunist;
Narcissism
Approaching the Interview
What is the objective or purpose of the
inspection?
What do I know?
What do I want to know?
What are the element of the concern?
What is the background of the
company/interviewee?
Skills and Attributes
 of the Inspector
Relevant training and knowledge on the
requirements and technical processes for the
specific inspection.
Demonstrate the 4 
P
s
Polite
Prepared
Professional
Patient
Do
s and Don
ts of Questioning
Don
t
Intimidate, interrogate or thick
Embarrass interviewees
Answer your own questions
Ask more than one question at a time
Ask too many question with a 
yes
 or 
no
 answer
Get sidetracked by answers
Say you understand if you don
t
Do
Interview and involve the right audience
Set a theme before posing questions
Include one main thought in each question
State questions clearly, concisely and audibly
Ask questions in a friendly and natural way
Use questions carefully and time them appropriately
Do
s and Don
ts of Questioning
Open-ended Questions
Require factual, detailed responses by the
interviewee.
Creates a dialog between the inspector and the
interviewee and answers are able to indicate
whether the interviewee understood the
questions.
Generally, one open-ended question will lead to
another through the dialog process.
Typically begin with : 
what, why, when, where,
who & how
 Types of open-ended questions include:
 Themed questions
 Expansive questions
 Investigative questions
 Opinion questions
 Repetitive questions
 Hypothetical questions
Open-ended Questions
Remember to…
Put interviewee at ease
prior to the interview
Be tactful and polite
Reflect the right attitude
and tone of voice
Use paraphrasing where
necessary
Watch body language and
facial expressions
Smile and show eye
contact
Listen actively and show
interest in the interviewee
Show patience and
understanding
Turn off your own
problems
Avoid off-the-cuff or
condescending remarks
Give praise when
appropriate
Say please and thank you
Themed questions: 
requires setting a theme before
posing a question,
 
e.g. : 
Talking of software validation, how do you…?
Expansive questions:
 
expands the conversation and also
creates a high level of empathy because they show that
the inspector is interested in interviewee
s responses. Can
often clear up vague areas as well as clarify the inspector
s
perceptions,
 
e.g. : 
How important is it for you to be advised of this
type of procedure?
; 
What areas are you thinking of?
;
Why do you feel there is a need for …?
Types of Open-ended Questions
Types of Open-ended Questions
Investigative questions: 
have an investigative role and also
useful when the inspector is not sure whether the
interviewee has fully understood a question but avoids
making it obvious,
e.g.: 
Can you tell me why this unit marked with a red tag is
on the pallet of finished goods tested?
Opinion question: 
useful for gaining someone
s attention
and confidence or for gaining new approaches to solving a
problem. Also indicates that the inspector regards the
interviewee view as important and encourages them to say
more,
 
e.g.: 
What do you think would be the most effective…?;
How would you go about …?
Repetitive questions: 
questions that may need to be
repeated or paraphrased for the purpose of eliciting more
information but overuse of repetitive questions should be
avoid.
Hypothetical questions: 
should also be used with care but
can be a good way of gauging priorities and contingency
planning.
e.g. : 
Suppose the power failed?
, 
What if no calculations
satisfied this equation?
Types of Open-ended Questions
Probing questions: 
Having stimulated the interviewee to
talk, the inspector may wish to pursue a particular point
further. Probing questions allow a focus on a point of
interest and yield more information. Usually also contain:
what, why, when, where, who & how. 
 
e.g. : 
Tell me more about how…?
Types of Open-ended Questions
Require a simple 
yes
 
or 
no
 
from the interviewee.
It does not allow you to judge if the question was fully
understood.
Does not promote a dialog and requires that the
inspector follow up with further questions.
Forces the auditor to do all of the work.
Types of closed questions include:
Assumptive questions
Leading questions
Loaded questions
Closed Questions
Assumptive Questions: 
these questions are formulated
based on assumptions and directed in such a way that a
straight answer needs the person answering to adhere to the
inspector
s assumption. 
E.g., 
How often do you do that?
(assumes that it
s done at least sometimes)
Leading Questions
: 
These questions point the interviewee  in
the direction of the answer and are best avoided. The may be
of use sometimes to secure the commitment of the
interviewee to a preferred line of action. 
E.g., 
So you will go
ahead with this corrective action and report back within
two weeks?
 
In this way, the inspector leads the question to
an obvious answer but may also get the commitment of the
interviewee to take the corrective action.
Types of Closed Questions
Loaded Questions: 
this type of question puts the
interviewee in a losing situation.  For example: 
Have you
stopped deviating from GMP?
 
if the answer is 
yes
, the
person is obviously a GMP violator, although a reformed
one.  If the answer is 
no
 then the person is an
uninformed GMP violator.  There is no answer for a
responsible person who does comply with GMP.
Types of Closed Questions
Combination Questions
Also called Clarifying Questions:
 
are a combination of
open and close questions and may be used to obtain
more information on a specific subject, or to eliminate
ambiguity. These questions can also be reassuring to the
interviewee as it demonstrates that the inspector has
been listening carefully and observing what has been
said accurately.
E.g. : 
Can you explain what you mean by that?
Non-Verbal Techniques
Silence:
 
This is the secret weapon in the inspector
s
armory as most people are very uncomfortable with
silence. If the response to an open-ended question leaves
the inspector with a strong impression that there is more
to come, it is worth remaining silent for a while. Almost
invariably the interviewee becomes uncomfortable and
start talking again. This technique has to be handled with
care and used only when the inspector is fairly confident
that there is more information to come or it may create
insecurity and anxiety on the part of the interviewee.
Non-verbal questioning:
 
For example, raising of the
eyebrows while maintaining eye contact can indicate a
wish for the interviewee to continue with his response
or to confirm what has been said. Also, simply looking at
the interviewee in an expectant manner following a
response often encourages him to carry on talking
without verbal interruption. Such a technique must be
used with care to avoid the appearance of an
interrogation.
Non-Verbal Techniques
Tone and Emphasis: 
Often a different meaning can be
conveyed by a question simply by altering the tone
and emphasis of its delivery. E.g., 
Who authorized
THAT?
 
– a simple request for information.
It can become: 
Who authorized THAT?
 
– meaning who
in their right mind would authorize that load of
rubbish?
Or: 
WHO authorized that?
 
– meaning (s)he hasn
t the
authority to do that.
Or even: 
WHO authorized THAT?
Non-Verbal Techniques
POWER & INFLUENCING STYLES,
 
HANDLING DIFFICULT BEHAVIOR, 
 
ELICITING OPTIMAL RESPONSES
PHILOSOPHY OF GMP INSPECTION
Power & Influencing Styles
You are in control of the inspection not the
organisation.
How do you demonstrate this?
Walk of Grace and Power:
From the car to Reception
From Reception to the Meeting Room
Entering the Meeting Room
You are in control 
of the auditing not the company.
Speak at 
100 words per minute
. This will recognized
sub-consciously that you are delivering a serious
message.
State clearly at the beginning 
that any company
presentations must be short and directly relevant 
to
the inspection.
Be prepared to interrupt politely if the company tries to
waste time with irrelevant company history or sales
figures.
Power & Influencing Styles
You have to take control of the Introductory meeting
immediately.
In the Meeting Room, sit in the chair with Grace and
Power.
Prepare your bag carefully so that you can arrange you
papers smoothly and confidently (No digging around
trying to find stuff!).
If using laptop, make sure that the battery is fully
charged. There is nothing more undignified than
scrambling around the floor under the table looking for a
power socket.
Power & Influencing Styles
The Easy Way (of course!)
The first step is to 
build rapport 
with the staff you
are talking to.
The first step is to arrange the Inspector
s room to
make it as comfortable and relaxed as possible:
Ensure that the seat next to you is empty 
so that
when staff come in to explain documents,
procedures, etc. they can sit next to you.
Keep the table free of excessive clutter, 
papers,
coffee mugs, etc. but not sterile.
What is the purpose of inspection &
How do you achieve it?
To convert Data to Information to Knowledge about
the company, the products and the processes.
Most companies collect boxes or gigabytes of data
but do little to convert it.
The Inspector can do this conversion the easy way or
the difficult way.
YOU need to change your behavior now:
Sit in the relaxed way in your chair – not as per the
Introductory Session where you are sitting with
Grace and Power.
Remember: You have to continually invite them to
talk.
You do this by using your listening skills.
The Easy Way (of course!)
Greet them nicely when they enter the room and
invite them to sit next to you.
Next, you put them at ease by some small talk.
It is important to remember that YOU have to
invite the person to talk. They will usually have
been instructed to strictly only answer your
questions and not to talk.
You need to get them relaxed in as short time as
possible and chatting.
The Easy Way (of course!)
Focus the person
s train of thought, not on what
your next question is going to be
If there is a gap in the response don
t rush in and
ask another question – the person might just be
thinking or trying to rephrase their answer – be
patient
When listening to an answer try to maintain
some eye contact
Listening Skills
Look at them when listening
Its OK to take brief notes/key word whilst listening
but not complete sentences under normal
circumstances. More detailed notes can be written
after the person has finished speaking if need be.
Show that you are listening, a nod of the head,
mmm, I see. It does not mean that you agree with
what they are saying just that you hear what they
are saying.
Listening Skills
Active listening – interested in hearing and
understanding and actively confirms that the
message is being understood both during and after
the answer. Repeat the words that they use.
Probably the most effective type of listening under
most circumstances.
Listening Skills
Passive listening – interested in hearing and
understanding but fails to verify the answer, e.g.
by paraphrasing or by not providing feedback 
I
see, mmm
Listening Skills
Communication Preferences
Most of us have a preferred way of communicating:
Audio (hearing)
I hear what you say
Visual (seeing)
I see what you mean
Kinaesthetic (feeling)
I feel that you are right
Communication
The best piece of advice I was given was
Remain in the here and now
 when asking
questions and listening to the answers.
It
s all too easy to let the mind wander and think
about other things.
The second best piece of advice I was given was: If
you are getting good clear answers to your
questions, you are asking the wrong questions!
 
Listen for the cues that will help you determine the
optimum way to communicate.
If you are not being understood try:
For the audio person – 
let me put it another way
For the visual person – 
let me show you what I mean
For the kinaesthetic person – 
 If your feel like that then
perhaps I can explain it this way
 
Communication
Difficult Behavior
By establishing Rapport immediately and by using
your communication skills then this will usually
prevent problems right at the beginning.
Other difficult behaviors:
Aggressive personality: tries to dominate / browbeat
the inspector.
Competitive personality: tries to show how  clever
they are.
  
Prevention is better than cure.
What causes difficult behavior?
Nervous
Worried
Blame culture
  
Difficult Behavior
You must behave like this every time the other
person starts. Starts as you mean to go on.
 
Example :
Unannounced inspection;
Complaints from other companies;
Managing Director angry & aggressive from start;
Have you ever performed an inspection?
I will tell you what the situation is!
I will get my lawyers on to you
 
 
 
Difficult Behavior: Anger
Always try to avoid responding to anger by anger.
It only makes things worse.
Take a deep breathe to keep calm.
Try to identify the emotion that the other
s anger
elicits in you and express it calmly and firmly,
using the first person singular.
I don
t like it when you speak to me like that
Difficult Behavior: Anger
I had my Agenda, MD had completely different
Agenda.
30 min verbal fight.
Time for new strategy:
Establish Rapport: 
Tell me about that
, 
Why do you
think that
, 
That
s an interesting point, tell me
more
.
Just listened for 30 min and did not challenge or discuss.
Used 
Clean Questioning Tool
.
Difficult Behavior: Anger
Don
t you ask questions just let me speak
You are completely wrong: Admit it!
I am going to complain to my MP
So what went wrong?
No opportunity to establish Rapport at the
beginning.
Ambience not conducive.
Difficult Behavior: Anger
LESSON LEARNT:
I needed to control the inspection from the start.
The MD was determined to control the inspection.
The initial fight was necessary in this case but I let it
go on for too long (30min).
I should have begun to establish Rapport after 10
min.
Difficult Behavior: Anger
Anger gradually dissolved
Rapport established
Now time for my Agenda!
Gradual acceptance that I too had a legitimate
point and that the company needed to change
Result: Company will comply.
Difficult Behavior: Anger
Difficult Behavior: Frustration
You (the inspector) just don
t get it!
 
e.g. : You have failed to understand what I have
said.
This is all too common when inspecting a
complex issue
 
e.g. : OOS or Deviation Reports
To avoid getting into this situation use the
Paraphrase
 
tool.
The Paraphrase Tool
Paraphrase question:  
From what you have told me,
whilst the SOP was followed exactly and there is an
audit trail, and incorrect dosing regime was
administered, is my understanding correct?
Use to confirm that you have understood what the
person has told you
Helps avoid misunderstandings and can save a lot
of time
The paraphrase question is a very powerful tool
and much underused.
Clean Question Tool
Clean questions – always start with 
And
And
 
after you have entered the data what
happens next?
And 
after that?
And 
then what happens?
And 
is there anything else?
And 
where does this information come from?
Clean questions lack emotional content and are
best used if the person is getting upset
Inspector Behavior
Occasionally we all make the mistake of implied
criticism of the individual and not the system.
This is usually down to poor use of words or using
inappropriately phrased questions.
Can result in tears, anger, resentment and
sullenness.
The situation can be recovered by using the 
Clean
Question
 tool.
The Hard Way
As I said earlier there is an easy way and a hard way of
achieving the objective of the inspection:
To convert Data to Information to Knowledge we have
looked at the easy way of doing this by getting the
company to do it for you.
Now let us look at an Inspector who does it the hard
way…
The Reflective Question Tool
Occasionally you may come across the situation where
somebody is very upset over a mistake that has
happened and you need to recover the situation.
Reflective question: 
So, you feel upset that even
though you followed the SOP this error was made?
Repeating back the emotional content of a person
s
statement is very powerful tool for creating
empathy and handling emotionally charged
situations.
Whilst this is an extreme picture, I have observed
these behaviors.
Whilst we as inspectors need to use these traits
sometimes, we need to be aware that soft skills
usually get the results much quicker and easier than
hard analytical skills.
As the Gold Sheet once said – beware of the
Inspector who gets you staff to talk!
The Hard Way
Characteristics of this inspector:
Happiest with raw data
Number crunching and data entry into
customised spreadsheets a speciality
Does not see people only data
Can spend hours observing a process
Fascinated by minutes: has trouble seeing
the big picture
The Hard Way
8 Core Beliefs of
Extraordinary Bosses
Business Is An Ecosystem, Not A
Battlefield
 
Average bosses 
see business as a conflict between
companies, departments and group. They build huge
armies of 
troops
 
to order about, demonize
competitors as 
enemies,
 and treat customers as
territory
 
to be conquered.
Extraordinary bosses 
see business as a symbiosis where
the most diverse firm is most likely to survive and thrive.
They naturally create teams that adapt easily to new
markets and can quickly form partnerships with other
companies, customers … and even competitors.
A Company Is A Community, Not A
Machine
 
Average bosses 
consider their company to be a machine
with employees as cogs. They create rigid structure with
rigid rules and then try to maintain control by 
pulling
levers
 
and 
steering the ship.
Extraordinary bosses 
see their company as a collection
of individual hopes and dreams, all connected to a
higher purpose. They inspire employees to dedicate
themselves to the success of their peers and therefore
to the community-and company-at large.
Management Is Service, Not Control
 
Average bosses 
want employees to do exactly what
they
re told. They
re hyper-aware of anything that
smacks of insubordination and create environments
where individual initiative is squelched by the 
wait and
see what the boss says
 mentality.
Extraordinary bosses 
set a general direction and then
commit themselves to obtaining the resources that
their employees need to get the job done. They push
decision making downward, allowing teams form their
own rules and intervening only in emergencies.
My Employees Are My Peers, Not My
Children
 
Average bosses 
see employees as inferior, immature
beings who simply can
t be trusted if not overseen by a
patriarchal management. Employees take their cues from
the attitude, expend energy on looking busy and covering
their behinds.
Extraordinary bosses 
treat every employees as if he or
she were the most important person in the firm.
Excellence is expected everywhere, from the loading
dock to the boardroom. As a result, employees at all
levels take charge of their own destinies.
Motivation Comes From Vision, Not
From Fear
 
Average bosses 
see fear--of getting fired, of ridicule, of
loss of privilege--as a crucial way to motivate people. As
a result, employees and managers alike become
paralyzed and unable to make risky decisions.
Extraordinary bosses 
inspire people to see a better
future and how they
ll be a part of it. As a result,
employees work harder because they believe in the
organization
s goals, truly enjoy what they
re doing and
(of course) know they
ll share in the rewards.
Change Equals Growth, Not Pain
 
Average bosses 
see change as both complicated and
threatening, something to be endured only when a form
is in desperate shape. They subconsciously torpedo
change … until it
s too late.
Extraordinary bosses 
see change as an inevitable part of
life. While they don
t value change for its own sake, they
know that success is only possible if employees and
organization embrace new ideas and new ways of doing
business.
Technology Offers Empowerment, Not
Automation
 
Average bosses 
adhere to the old IT-centric view that
technology is primarily a way to strengthen management
control and increase predictability. They install
centralized computer systems 
that dehumanize and
antagonize employees.
Extraordinary bosses 
see technology as a way to free
human beings to be creative and to build better
relationships. They adapt their back-office systems to the
tools, like smartphones and tablets, that people actually
want to use.
Work Should Be Fun, Not Mere Toil
 
Average bosses 
buy into the notion that work is, at best,
a necessary evil. They fully expect employees to resent
having to work, and therefore tend to subconsciously
define themselves as oppressors and their employees as
victims. Everyone then behaves accordingly.
Extraordinary bosses 
see work as something that should
be inherently enjoyable-and believe therefore that the
most important job of manager is, as far as possible, to
put people in jobs that can and will make them truly
happy.
 
88
Slide Note
Embed
Share

The ASEAN Guidelines on GMP for Traditional Medicines highlight the Philosophy of Inspection for ensuring quality and safety in traditional medicines and health supplements. The document covers legal terms, audit trail requirements, electronic signature control, and familiar auditor requirements. It emphasizes the importance of upholding rights, making informed decisions, and implementing secure electronic signature processes in the production and distribution of traditional medicines and health supplements.

  • ASEAN Guidelines
  • GMP
  • Traditional Medicines
  • Health Supplements
  • Inspection

Uploaded on Sep 15, 2024 | 0 Views


Download Presentation

Please find below an Image/Link to download the presentation.

The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.

E N D

Presentation Transcript


  1. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements (TM/HS) PHILOSOPHY OF GMP INSPECTION Prepared by: Malaysia Approved by: ASEAN TMHS GMP Task Force Endorsed by: ASEAN TMHS Product Working Group 1

  2. Legal Terms Right to be heard: No person shall be condemned, punished or have any property or legal right compromised by a court of law or authority action without having heard that person. Suspensive effective: The postponement of the execution of a decision pending the outcome of an appeal. 2 ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  3. Legal Terms Decision: A judgment, decree, or determination of findings of fact and/or of law by a judge, arbitrator, court, governmental agency, or other official court. Advance notice: Informs the addressee about the decision that will be taken to guarantee the addressee s right to be heard. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  4. Most auditors would be familiar with the following requirements: Audit trails Backup (if applicable) Archiving Disaster Recovery ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  5. Where electronic signatures are required, the following must be controlled : Authorized user log-on for a specific application A unique password called for the CS, linked to the authorized account for a specific application Permitted task functionality for that user Common time and standard referencing and transaction linking Time stamped audit trail System information security ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  6. Audit trail requirements: The system should record the identity of operators entering or confirming critical data. Any alteration to an entry of critical data should be authorized and recorded with the reason for the change. Consideration should be given to building into the system the creation of a complete record of all entries and amendments (an audit trail ). ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  7. Audit trail requirements: Any alteration made to the entry on a document should be signed and dated. The alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  8. Audit trails function: To independently record: the date and time of operator entries creations, modifications, or deletions of electronic records to verify that record changes do not obscure previously recorded information. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  9. Audit trail must be: Secured System generated Immutable Time stamped ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  10. The Attributes of an Inspector Remember that in an AUDITTING . Unlimited number of possible scenarios Is a systematic approach Involves interpersonal skills Identifies deficiencies Look at what went wrong Requires participation from both parties Good Inspection Skills ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  11. The Attributes of an Inspector We must respect the codes of ethics and conduct; Keep objectivity, impartiality, confidentiality Mandatory good diplomat Quality System mandatory for all inspectorates ? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  12. The Attributes of an Inspector PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES 3. PURPOSE The purpose of adopting a common standard of inspection is to achieve consistency in auditing standards between auditors and thus to Facilitate mutual recognition and AUDITORS / INSPECTORATES confidence between ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  13. The Attributes of an Inspector PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES The personnel of the auditing service, should be free from any commercial, financial and other pressures which might affect their judgment and freedom to act. Auditor should ensure organizations external to the audited organization cannot influence the result of the audit. Rules for deontology, ethics, conflict of interest and improper influence should be clearly defined. that the persons or ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  14. The Attributes of an Inspector PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES When more than one auditor is involved in an audit, a lead inspector should be appointed to coordinate audit activities. The audit report should normally be prepared by the lead auditor and should be agreed by all participating auditors. Observations and/or data obtained in the course of the audit should be recorded in a timely manner to prevent loss of relevant information. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  15. The Attributes of an Inspector Technical Aspects The auditor should have the skill to make professional judgments based on Facts and Science as to the conformity of the audited party with the requirements of good practices and the relevant legislation / guidelines and be able to make an appropriate risk assessment. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  16. The Attributes of an Inspector Technical & Non technical Aspects The credibility of a auditing process will depend to a large degree on the technical competence and integrity of the auditor but The non-technical skills are equally important to the final outcome. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  17. The Attributes of an Inspector Non-technical Aspects Clothing Dress accordingly & Taking in account the country codes Note: Important for women inspectors, given the variability of custom clothing ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  18. The Attributes of an Inspector Non-technical Aspects Remember that as an inspector, we are obliged to PREPARE how you will introduce yourself, the interview & its purpose ASSESS already available info SPECIFY interview objective Preparation Flexibility & Set limits Objectivity Positive attitude Integrity Always do your homework: Perfect Preparation Prevent Poor Performance Coherence Good Organization Skills ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  19. The Attributes of an Inspector Non-technical Aspects Good Communication Skills Language Body language Personality, Emotions, Culture Note: Personality as a dynamic and organized set of characteristics possessed by a person that uniquely influences his or her cognitions, motivations, and behaviors in various situations. The word personality originates from Latin persona, which means mask. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  20. The Attributes of an Inspector Non-technical Aspects Remember that we are obliged to . PLANNING AHEAD Good Time Management Define objectives Set priorities Detect weaknesses Detect inconsistencies Check traceability Manage bad conduct & conflicts Manage people/processes Creating links Manage the situation / process / Manage time ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  21. The Attributes of an Inspector Non-technical Aspects An audit process requires participation from both parties with questions followed by answers that frequently, the response will lead to the next question, so we must be a good listener ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  22. The Attributes of an Inspector Non-technical Aspects A positive atmosphere makes inspections much more easier for both parties ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  23. The Attributes of an Inspector Non-technical Aspects Asking Questions . Open questions stating with: How? Where? Who? What? Why? When? Good questioning skills Silence can be very powerful ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  24. The Attributes of an Inspector Non-technical Aspects Good listening practices Active listening & avoid misunderstanding or Passive listening and paying attention Hear the person out & be patient Show the person that you are listening & interested Encourage the person to continue e.g. by facing the person repeat important information with your own words wait for the confirmation Be approachable Try to understand the speaker s points of view ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  25. The Attributes of an Inspector Non-technical Aspects At Meeting Do Not Include: Subjective opinions Irrelevant information Ambiguous statement Antagonistic statement New deficiencies which are not previously discussed! Transparency ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  26. The Attributes of an Inspector Non-technical Aspects At Meeting: Good communication & interpersonal skills Inspector must lead Concise presentation Discussion Know when to invite discussion and when to limit the discussion Mention good points before deficiencies Treat challenges politely Discuss and resolve conflicts Admit if wrong Don t back down if convinced you are right ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  27. The Attributes of an Inspector Non-technical Aspects Should be aware of the auditor s influence Careful interfering in well coordinated process / systems Avoid entering the role of a consultant Tell what is wrong Why it is wrong But not how to change! ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  28. The Attributes of an Inspector Non-technical Aspects Disclosure of faults, deficiencies, discrepancies How to say it How to find the key to the understanding of the other party Good Interpersonal skills ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  29. The Attributes of an Inspector Non-technical Aspects Avoid & Control Bad predisposition & Prejudgment Underestimate the auditee Excessively emotional Hubris, Arrogance & Truculence Inexperience Bad preparation of inspection Interest conflicts Personal interpretation of guidelines Negligence; opportunist; Narcissism ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  30. Approaching the Interview What is the objective or purpose of the inspection? What do I know? What do I want to know? What are the element of the concern? What is the background of the company/interviewee? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  31. Skills and Attributes of the Inspector Relevant training and knowledge on the requirements and technical processes for the specific inspection. Demonstrate the 4 P s Polite Prepared Professional Patient ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  32. Dos and Donts of Questioning Don t Intimidate, interrogate or thick Embarrass interviewees Answer your own questions Ask more than one question at a time Ask too many question with a yes or no answer Get sidetracked by answers Say you understand if you don t ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  33. Dos and Donts of Questioning Do Interview and involve the right audience Set a theme before posing questions Include one main thought in each question State questions clearly, concisely and audibly Ask questions in a friendly and natural way Use questions carefully and time them appropriately ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  34. Open-ended Questions Require factual, detailed responses by the interviewee. Creates a dialog between the inspector and the interviewee and answers are able to indicate whether the interviewee questions. Generally, one open-ended question will lead to another through the dialog process. Typically begin with : what, why, when, where, who & how understood the ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  35. Open-ended Questions Types of open-ended questions include: Themed questions Expansive questions Investigative questions Opinion questions Repetitive questions Hypothetical questions ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  36. Remember to Put interviewee at ease prior to the interview Be tactful and polite Reflect the right attitude and tone of voice Use paraphrasing where necessary Watch body language and facial expressions Smile and show eye contact Listen actively and show interest in the interviewee Show patience and understanding Turn off your own problems Avoid off-the-cuff or condescending remarks Give praise when appropriate Say please and thank you ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  37. Types of Open-ended Questions Themed questions: requires setting a theme before posing a question, e.g. : Talking of software validation, how do you ? Expansive questions: expands the conversation and also creates a high level of empathy because they show that the inspector is interested in interviewee s responses. Can often clear up vague areas as well as clarify the inspector s perceptions, e.g. : How important is it for you to be advised of this type of procedure? ; What areas are you thinking of? ; Why do you feel there is a need for ? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  38. Types of Open-ended Questions Investigative questions: have an investigative role and also useful when the inspector is not sure whether the interviewee has fully understood a question but avoids making it obvious, e.g.: Can you tell me why this unit marked with a red tag is on the pallet of finished goods tested? Opinion question: useful for gaining someone s attention and confidence or for gaining new approaches to solving a problem. Also indicates that the inspector regards the interviewee view as important and encourages them to say more, e.g.: What do you think would be the most effective ?; How would you go about ? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  39. Types of Open-ended Questions Repetitive questions: questions that may need to be repeated or paraphrased for the purpose of eliciting more information but overuse of repetitive questions should be avoid. Hypothetical questions: should also be used with care but can be a good way of gauging priorities and contingency planning. e.g. : Suppose the power failed? , What if no calculations satisfied this equation? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  40. Types of Open-ended Questions Probing questions: Having stimulated the interviewee to talk, the inspector may wish to pursue a particular point further. Probing questions allow a focus on a point of interest and yield more information. Usually also contain: what, why, when, where, who & how. e.g. : Tell me more about how ? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  41. Closed Questions Require a simple yes or no from the interviewee. It does not allow you to judge if the question was fully understood. Does not promote a dialog and requires that the inspector follow up with further questions. Forces the auditor to do all of the work. Types of closed questions include: Assumptive questions Leading questions Loaded questions ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  42. Types of Closed Questions Assumptive Questions: these questions are formulated based on assumptions and directed in such a way that a straight answer needs the person answering to adhere to the inspector s assumption. E.g., How often do you do that? (assumes that it s done at least sometimes) Leading Questions: These questions point the interviewee in the direction of the answer and are best avoided. The may be of use sometimes to secure the commitment of the interviewee to a preferred line of action. E.g., So you will go ahead with this corrective action and report back within two weeks? In this way, the inspector leads the question to an obvious answer but may also get the commitment of the interviewee to take the corrective action. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  43. Types of Closed Questions Loaded Questions: this type of question puts the interviewee in a losing situation. For example: Have you stopped deviating from GMP? if the answer is yes , the person is obviously a GMP violator, although a reformed one. If the answer is no then the person is an uninformed GMP violator. responsible person who does comply with GMP. There is no answer for a ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  44. Combination Questions Also called Clarifying Questions: are a combination of open and close questions and may be used to obtain more information on a specific subject, or to eliminate ambiguity. These questions can also be reassuring to the interviewee as it demonstrates that the inspector has been listening carefully and observing what has been said accurately. E.g. : Can you explain what you mean by that? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  45. Non-Verbal Techniques Silence: This is the secret weapon in the inspector s armory as most people are very uncomfortable with silence. If the response to an open-ended question leaves the inspector with a strong impression that there is more to come, it is worth remaining silent for a while. Almost invariably the interviewee becomes uncomfortable and start talking again. This technique has to be handled with care and used only when the inspector is fairly confident that there is more information to come or it may create insecurity and anxiety on the part of the interviewee. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  46. Non-Verbal Techniques Non-verbal questioning: For example, raising of the eyebrows while maintaining eye contact can indicate a wish for the interviewee to continue with his response or to confirm what has been said. Also, simply looking at the interviewee in an expectant manner following a response often encourages him to carry on talking without verbal interruption. Such a technique must be used with care to avoid the appearance of an interrogation. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  47. Non-Verbal Techniques Tone and Emphasis: Often a different meaning can be conveyed by a question simply by altering the tone and emphasis of its delivery. E.g., Who authorized THAT? a simple request for information. It can become: Who authorized THAT? meaning who in their right mind would authorize that load of rubbish? Or: WHO authorized that? meaning (s)he hasn t the authority to do that. Or even: WHO authorized THAT? ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  48. PHILOSOPHY OF GMP INSPECTION POWER & INFLUENCING STYLES, HANDLING DIFFICULT BEHAVIOR, ELICITING OPTIMAL RESPONSES ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  49. Power & Influencing Styles You are in control of the inspection not the organisation. How do you demonstrate this? Walk of Grace and Power: From the car to Reception From Reception to the Meeting Room Entering the Meeting Room ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

  50. Power & Influencing Styles You are in control of the auditing not the company. Speak at 100 words per minute. This will recognized sub-consciously that you are delivering a serious message. State clearly at the beginning that any company presentations must be short and directly relevant to the inspection. Be prepared to interrupt politely if the company tries to waste time with irrelevant company history or sales figures. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Philosophy of Inspection

Related


More Related Content

giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#giItT1WQy@!-/#