Internal Audit Presentation - Drug Int.

RM Consultancy Services
PART - I
DEFINITIONS
(ISO 9001:2008)
DEFINITIONS
QUALITY:
Degree to which a set of inherent/inborn/natural
characteristics fulfills requirements
CUSTOMER SATISFACTION:
Customers perception of the degree to which the
customers requirements have been fulfilled
QUALITY MANAGEMENT SYSTEM:
Management system to direct and control an
organization with regard to quality
QUALITY POLICY:
Overall intentions and direction of an organization
related to quality as formally expressed by top
management
DEFINITIONS (cont.)
QUALITY OBJECTIVE:
Something sought, or aimed for, related to quality
QUALITY MANAGEMENT:
Coordinated activities to direct and control an
organization with regard to quality
QUALITY CONTROL:
Part of quality management focused on fulfilling quality
requirements
QUALITY ASSURANCE:
Part of quality management focused on providing confidence
that quality requirements will be fulfilled
DEFINITIONS (cont.)
CONTINUAL IMPROVEMENT:
Recurring activity to increase the ability to fulfill
requirements
EFFECTIVENESS:
Extent to which planned activities are realized and planned
results achieved
EFFECIENCY:
Relationship between result achieved and the resources
used
ORGANIZATION:
Group of people and facilities with an arrangement of
responsibilities, authorities and relationships
DEFINITIONS (cont.)
ORGANIZATIONAL STRUCTURE:
Arrangement of responsibilities, authorities and
relationships between people
INFRASTRUCTURE:
Set of facilities, equipment and services needed for the
operation of an organization
WORK ENVIRONMENT:
Set of conditions under which work is performed
PROCESS:
Set of interrelated or interacting activities which
transforms inputs into outputs
PRODUCT:
Result Of A Process
DEFINITIONS AND TYPES OF AUDIT

KEY POINTS
Audit Definition
Types of Audit
Phases of Audit
DEFINITION OF AUDIT:
A systematic, independent and documented process for
obtaining audit evidence and evaluating it objectively to
determine the extent to which agreed criteria are
fulfilled.
DEFINITIONS AND TYPES OF AUDIT(cont.)

AUDIT EVIDENCE:
Records, statements of fact or other information
relevant to the agreed criteria and which can be crosschecked.
AUDIT FINDINGS:
Result of an audit.
AUDITEE:
Organization/client person being audited
AUDITOR:
Person appointed to conduct an audit

TYPES OF AUDIT
There are three types of audit:
FIRST PARTY AUDIT (Internal Audit):
Definition: An audit by the organization of its own
systems and procedures.
Objective: To assure maintenance, development and
improvement of the Quality System.
SECOND PARTY AUDIT (External Audit):
Definition: An audit by the organization on its suppliers.
Objective: To determine suitability of suppliers to
appraise their performance.

THIRD PARTY AUDIT (External Audit):
DEFINITION: An audit by a body which is
commercially and contractually independent of the
organization, its suppliers and customers. Commonly,
an audit by a certification body to a quality system
standard.
OBJECTIVE: To determine whether an organizations
quality system has been documented and implemented
in accordance with a specified standard.
10
PHASES OF AN AUDIT
Planning
Preparation
Performance
Reporting and Follow-up
(These apply to FPA,SPA and TPA)
Remember!
Proper Planning and Preparation Prevent Poor Performance
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PHASES OF AN AUDIT (cont.)

AUDIT PLANNING
Frequency/ Timing
Responsibility
Criteria
Scope
Duration
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Audit Planning
Day - 1
THE AUDIT PROGRAM
0900 - 1100
Production: QA Manager
1100 - 1300
Store :QA Manager
1300 - 1400
Lunch Break
1400 - 1600
QA
1600 - 1700
Maintenance: Production
Manager
:Production Manager
13

CONDUCTING THE AUDIT
The auditor should adopt a positive, professional and
constructive approach. In common with this, the auditor
should try to obtain a co-operative, open and honest
approach from the auditee.
To achieve these objectives the auditor should
meet the area representative first
always talk to those performing the task
explain the purpose of visit
be polite, calm and supportive
never talk down, never act superior
speak clearly and carefully
14

The auditor should use all of his/her senses when carrying
out the audit. He or she must examine the objective
evidence and ask open-ended questions. They must refer
to their checklists and make notes. Should they discover a
deficiency, they should consider the full impact of the
problem, and the actual physical conditions of the area or
processes under audit.
Evidence of Audit will include:
Documents, records
Physical evidence
Environmental Condition (if applicable)

15

The auditor should look for clear completion of information
and accuracy of data. Documents should always be
checked for signature. If a document is incomplete then a
sample of other similar documents should be studied to
establish the extent of non-compliance.
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QUESTIONING TECHNIQUE
SIX WORDS those are important to Auditor.

How, Where, When, What, Why, Who
The auditor should ask efficient, open-ended questions.
Those which invite a Yes or No answer will close down
the conversation. However, there may be times in the
audit when such an answer is required.
17

QUESTIONING TECHNIQUE -1
The main task of the auditor is to extract the main
information. A question such as: where do you keep your
copy of the preferred suppliers list? extract an answer, in
the file. This shows that the auditee knows there should
be one and knows where it is.
An auditor might ask an individual : have you been trained
for the job you do? Again this is inefficient. It would be
better to ask : how were you trained for this? or what
training did you receive?
18

A question such as: where is it kept while not in use?
establishes storage and filing. Likewise, a question such as
what do you do with the paperwork and items when
inspection is complete? will encourage an answer which will
provide information on documentation flow.
An alternative method of questioning which will also
encourage the auditee to discuss and present objective
evidence is show me. For example : show me your
preferred suppliers list.
19

A few more examples :
Show me what you do.
Where is that kept?
How is that carried out?
When would you do this?
What happens after this is completed?
Who will do it?
20
Avoid Leading Questions such as:
I see that once your job is completed you file the record in
the depository, am I right?
This will only get a yes, no or nodded response.
21

CONTROLLING THE AUDIT
The Auditor must control the Audit.
DO NOT
- be side track
- be lead/guide or mislead / give the wrong impression about
- get bogged down
- let the auditee say the pace/speed of the audit
make assumptions or presumptions.
be sarcastic/ironic/clinical
Swear/give your word
be negative
Criticize
argue
compare the auditee with others.
22
DO
be prepared
be punctual
insist on the person being questioned answer for
themselves
as little talking as possible
avoid misunderstanding
keep questions clear and to the point
be polite and calm
give compliments
23

AUDITOR SHOULD BE:
open minded
unbiased
- diplomatic
- flexible
- self disciplined
honest
Empathetic/sympathetic
- good listener
- uncomplaining
- expressive
- able to communicate
- interested
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The auditor must be prepared for, and be aware of, a range of
possible occurrences during the course of the audit.
For Example:
aggressive auditees
nervous/shy auditees
missing people
missing documents
pre-prepared samples (always choose your own)
special cases
emotional blackmails
25

NONCOMPLIANCE
A
-
noncompliance is also referred to as a:

deficiency
finding
nonconformance
26

A noncompliance may be a failure to:
comply with the standard applicable to the organization
implement quality manual, procedures or other
documentation requirements
specified by the organization
implement a code of practice, regulation, contract etc.
REMEMBER!
If there is no specified requirement, there can be no
noncompliance. What an auditor thinks should be done is
not a specified requirement.
27

FINDING STATEMENT
A short statement which should contain:
overview of finding
description of noncompliance
example of objective evidence
summary of the requirement
The document on which the statement is recorded should
indicate :
the applicable procedure and issue
area/department or function
standard and clause number
28
Example of Noncompliance Statement:

NC-Findings: A new supplier of electric motors was not selected on their
ability to meet specified requirements, but on price.
Specific Requirements: Suppliers and subcontractors must be selected
on the basis of their ability to meet specified requirements, in accordance
with procedure
29

CORRECTIVE ACTION REQUEST (CAR)
CAR is used to describe a noncompliance and request action.
- CAR is raised after careful consideration at the auditors
private review prior to the closing
- meeting with the organization.
- A corrective action request will give the level or classification
of the noncompliance.
Classification of NC (Nonconformity)
- Major
- Minor
30

MAJOR NC
COMPLETE ABSENCE OF A STATEMENT OR

PROCEDURE TO MEET A REQUIREMENTS OF THE
STANDARD (ISO 9001:2008)
BREAKDOWN OR NON OBSERVANCE OF A SPECIFIED
REQUIREMENTS
MINOR NC
SINGLE OBSERVED LAPSE IN THE USE OF A DEFINED

PROCEDURE OR REQUIREMENTS
A NUMBER OF MINOR NCs AGAINST ONE PROCEDURE
OR REQUIREMENTS, AROUND THE ORGANIZATION
OR IN A SINGLE DEPARTMENT, PROVING A
BREAKDOWN, CAN BECOME A MAJOR NC.
31
MINOR NC
Raised when a deficiency (or deficiencies) has been identified in a
procedure or work instruction or in the operation of the
organizations QMS, but which are less harsh than warrants a Major
NC.
The following action(s) shall be taken after a nonconformity is
identified:
Must be corrected and verified and closeout within
defined interval
The classification of NCs is based upon good judgement, expertise
and experience of the auditor.
However, The classification of noncompliance is not necessary for
Internal Audits
32

REPORTING
Depending on the type of audit, the report will include, as

applicable, the following details:
name of organization
audit date(s)
audit location
QA standard (ISO 9001:2008)
audit team members
NCR issued
attendees at opening and closing meetings
summary of the main points of the audit
33

The report should not include :
-
deficiencies discovered and corrected during the audit

confidential information given in interviews
matters not raised or discussed at closing meeting
subjective opinions - verifiable facts only
ambiguous/confusing statements
aggressive words or phrases
34
AUDITOR SELECTION (cont.)

RESPONSIBILITY OF AN AUDITOR
The responsibilities of an auditor are to:
comply with the audit requirements
communicate and clarify the audit requirements
plan and carry out assigned duties effectively and
efficiently
document corrective actions requests, observations
and objective evidence
report audit findings
verify effectiveness of corrective actions
retain and safeguard documents
co-operate and support the lead auditor
35
OBJECTIVE OF AN INTERNAL AUDIT
OBJECTIVES OF AN INTERNAL AUDIT

-
To reveal/disclose deficiencies in the documented

system
To reveal /disclose deficiencies in the implementation
of the documented system
To constantly/continually measure achievement in
terms of management compliance
To serve as a tool for corrective action to examine
effectiveness of improved system
To identify opportunity for improvement
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FACT FINDING METHOD
READING
COMMUNICATION
INTERVIEWING
LISTENING
FIRST QUESTION
USE OF CHECKLIST
TAKE NOTES
SPOT CHECK DOCUMENTS
RECORDS SAMPLES
OBSERVATION
BODY LANGUAGE
QUESTIONING
SELECTING SAMPLE YOURSELF
37

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RM Consultancy Services

DEFINITIONS AND TYPES OF AUDIT

DEFINITIONS AND TYPES OF AUDIT(cont.)

DEFINITIONS AND TYPES OF AUDIT(cont.)

DEFINITIONS AND TYPES OF AUDIT(cont.)

PHASES OF AN AUDIT (cont.)

THE AUDIT PROGRAM

Store :QA Manager

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

Environmental Condition (if applicable)

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

SIX WORDS those are important to Auditor.

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

Show me what you do.

Where is that kept?

How is that carried out?

When would you do this?

What happens after this is completed?

Who will do it?

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

noncompliance is also referred to as a:

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

Example of Noncompliance Statement:

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

COMPLETE ABSENCE OF A STATEMENT OR

SINGLE OBSERVED LAPSE IN THE USE OF A DEFINED

PHASES OF AN AUDIT (cont.)

PHASES OF AN AUDIT (cont.)

Depending on the type of audit, the report will include, as

PHASES OF AN AUDIT (cont.)

deficiencies discovered and corrected during the audit

AUDITOR SELECTION (cont.)

OBJECTIVE OF AN INTERNAL AUDIT

OBJECTIVES OF AN INTERNAL AUDIT

To reveal/disclose deficiencies in the documented

FACT FINDING METHOD

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