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“A systematic and independent examination to

determine whether quality related activities and
their results comply with documented systems,
are effectively implemented and are suitable for
achieving the quality objectives. ”
 “ Every audit is unique due to the auditor and
auditee and its varies by personal judgment,
past experiences, auditing style , basis
perceptions, opinions , culture value
systems, personalities and management
style. ”
Principles of Audit :

Auditor must be independent of the activity being
audited. They must remain free from bias and
conflicts of interest
Audit evidence must be verifiable and on sample
Types of Audits :
 First Party : An audit by the organization of its
own systems and procedures.
(Internal Audit / Self inspection)

 Second Party /External :An audit conducted by

its supplier/customer.

 Third Party :An audit by a body which is

commercially and contractually independent of
the organization, its suppliers and customers.

 In order to verify compliance with the principles

of GMP, regular internal audits should be
performed in accordance with an approved
 Audit findings and corrective actions should be
documented and brought to the attention of
responsible management of the firm. Agreed
corrective actions should be completed in a
timely and effective manner.
Internal Audit means ,
It is a check to ensure that the quality
management systems are operating effectively
in accordance with the established standards.

To update and ensure implementation of

SOPs/Policies across the organization as per
approved quality system.

To Review, analyze and evaluate the present

technical documents in the light with regulatory
guidelines and current industry practices and
approved procedure.
Keys for effective internal Audits :

1.0 Independence
2.0 Staffing and Training
3.0 Audit Planning
4.0 Relationships
5.0 Due Care
6.0 Evaluation of the internal control system
7.0 Evidence
8.0 Reporting and follow-Up
Keys for effective internal Audits :

1.0 Independence : The internal auditors should be a

independence in term of organisational status ,
department and personal objectives.

2.0 Staffing and Training : The internal audit teams should

be appropriately staffed in terms of numbers, qualifications
and experience, having regard to its responsibilities and
objectives. The internal auditor should be properly trained
to fulfil all his responsibilities
Keys for effective internal Audits :

3.0 Audit Planning :

 Be ready with audit agenda, check-lists etc.
 Be punctual and to the point.
 Follow the required entry/exit procedure

Audit objective, Audit Scope and Audit team should

Keys for effective internal Audits :
Audit Checklist :checklist.tif
 Guide to auditors for samples, time.
 To control the depth of the audit
 To control the pace of the audit
 It helps to ensure that audit area is covered
completely – Nothing is missed.

 May restrict for analysis of problem in depth.
 May prevent the auditor from investigating significant
incidents simply because they were not on checklist
Keys for effective internal Audits :
4.0 Relationships: Internal audit can be performed
properly , when auditors has confidence in auditee.
5.0 Due Care : To demonstrate the due care , the internal
auditor should be able to show that his work has been
performed in a way which is consistent with regulatory
requirements. The internal auditor should possess a
thorough knowledge of the aims of the organisation and
the internal control system.

6.0 Evaluation of the internal control system : To ensure

compliance with statutory requirements.
Keys for effective internal Audits

7.0 Evidence : The collection and assessment of internal

audit should be recorded and reviewed to provide
reasonable assurance that conclusions are soundly
based and internal audit objectives achieved.

8.0 Reporting and follow up :The internal auditor should

ensure that findings, conclusions and recommendations
arising from each internal audit assignment are
communicated promptly to the appropriate level of
management and it is implemented .
Qualities of an Effective Auditor
An auditor need to be….
 Educated , Open minded, Experience ,and
 Diplomatic (Tactful in dealing with people)
 Observant (Aware of physical surroundings)
 Perceptive (Understand the situations)
 Decisive (Timely conclusion based on logic)
 Self-reliant (Interact but function independently)
 Firm (Persistent, focused)
 Honest
 Professional Approach
Do’s and Don'ts

Do not interrupt
Be Punctual
to auditee Don’t shout

Stop and Listen

carefully Don’t run Don’t argue
Responsibilities of auditors
 Auditor should remain polite, calm and professional at all
 Introduce with the purpose/scope
 Keep to agenda
 Keep control (never talk down)
 Listen to others
 Speak clearly and carefully
 Stay within the audit scope.
 Communicate the audit requirements.
 Collect evidence (for and against)
 Document non-compliances.
 Verify the corrective actions/compliances
 Give compliments/Appreciate for good things
 Don’t assume on opinions versus fact that what you saw
Auditor Should be Prepared
 Unsystematic and unfocussed approach
 Negative feelings and opinions about audits in
the minds of auditee.
 Planned during wrong period
 Extended beyond defined scope
 Aggressive auditees
 Less talking auditees
 Missing people
 Missing documents
Special cases
 Emotional blackmail
What Auditor should look for ….?
 Personnel: Health and hygiene.
 Storage of Materials
 Receipt Procedures
 Man and Material flow
 Testing
 Production , Packing and process controls
 Systems and procedures
 Qualifications and Validations
 Facility
 Deviation
 Change control
 Risk assessment
 Rejects and refusals
 Complaints
 Investigations
 Calibrations
 Environmental conditions
 Training
But not limited.
Techniques of Audits:

1. Collect and verify the information

2. Observations
3. Interview
4. Record review ( Document , process and
Product review )
5. Tracking
Case Study
 Picnic
 Rainy season
 Car
 Village
 Prince
 Black Horse
 Jungle
 Palace
 Coffee
 Temple
 Journey
Techniques of Audits:
1.0 Collect and verify the information.
Collect and Verify documents ,records ,
procedure , specification , log books and

2.0 Observation :
 Observed the activity.
Don’t obstruct and don’t stare.
Techniques of Audits:
3.0 Interview :
 Ask-open-ended question .

 Ask-Closed ended question .

 Question techniques : When, where ,Who , How , show me

 Interview the person while performing the activity at workplace.

 Leading questions should be avoided.

 Do not conclude by yourself on assumption

 KEEP EYES AND EARS OPEN (Learning , Attending ,Understanding,

Concentrating ,Remembering and Continually grasping and processing
information )

 Results from the interview should be summarized and any findings should be

 Every attempt should be made to give ease to the person .

Techniques of Audits:
4.0 Record review ( Document , process and
Product review )
 Ask questions, review records and procedures.
 Give auditee a chance to explain and defer
situations to the audit team leader.
5.0 Tracking
 If a problem is found, check requirements ,
procedure and standards , notify the audit leader ,
assess the impact on the product and recommend to
management to stop the production or process.
Eg :


Batch records
 RAW /Packing material
Dispatch  RECEIPT

Manufacturing Approved Vendor



Audit report
 State decision and conclusion
 Summarize positive and good points
 Explain major , minor and critical non-compliances.
 Explain the findings and evidences carefully and
 Stress confidentiality.
 Review on-line compliances if any.
 Give recommendations for improvements
Self inspection

Composition of self inspection :

 There should be minimum two inspectors , including
one from Quality Assurance.
 Self-inspection team members should be
independent from those having direct responsibility
for the areas being inspect.
 Team consists of qualified, experienced senior
personnel who can evaluate the situation objectively.
There should not be any conflict of interest before
carrying out the self-inspection.
 Procedure for Self inspection :
 All the areas should be covered under self-inspection at least twice a
year or whenever required.

 The self-inspection schedule is made by Quality Assurance CQA-

54/A2. The self inspection should be completed within 15 days of
the scheduled date.

 Self inspection log is maintained as per CQA-54/A1 .

 A Self inspection number is issued by Quality Assurance department

on individual self inspection report as follows SIRI$$/@@
SIR - Self inspection report
$$ - last two digits of the Current Year
Serial number starting from 01

 Annexure CQA-54/A4 should be filled separately for each non

compliance recorded as per specimen Annexure CQA-54/A3.
Report Finding :
Non compliances are classified into “Critical”,
“Major” and “Minor” .
 Critical : Non-conformances, which have direct
impact on the quality of the product.
 Major : Non-conformances which may have indirect
impact on quality of the product.
 Minor : Non-conformances which may not have
impact on quality of the product.
 All observations noticed during the self
inspection should be submitted within 48 hrs in
Annexure CQA-54/A3 .
 Inspector should discussed the non conformances points
with Head of department , Quality Assurance and Unit
Head .

 Investigation of each non-conformance points should be

justified in annexure CQA-54/A4 by an auditee.

 Non- conformance submitted criteria :

 Critical non-conformance : Within 24 hours
 Major and Minor non-conformance :Within 15 days.

 Close out of self-inspection report : Within 30 days.

 Trending of the self inspection findings :Six monthly

Certification of self inspector
 For evaluation as a Self Inspector, an individual shall
participate in three self inspections along with
experienced and certified self inspector.

 Phase l : Observer
 Phase ll : Assist the experience self inspector
 Phase lll : The individual under evaluation shall work
as self inspector and the activities shall be monitored
by the experienced Self Inspector.
 Evaluation is carried out out during each phase by
certified self inspector as per Annexure QA-10
A26.tif .
 Evaluation shall be done for each section in the
department separately.
 Based on evaluation Quality Assurance shall issue
certificate for designated section as per Annexure
Internal audit

 Internal audit program help in solving problem ,

improvement ,root cause analysis and provides
tools to capture effectiveness.

 In current changing scenario of regulatory

requirements, inspection and inspection approach,
there is need to strengthen Policies by internal
audit to Upgrade and Harmonize Quality Policy
and ensure effective implementation.
 EU GMP Guidelines
 Indian GMPs : Schedule M
 Canada Guideline
 Internal Audit Committee of the Malaysian Institute of
Accountants from the publication "Guidance for
Internal Auditors" issued in June 1990 under the aegis
of the Consultative Committee of Accountancy Bodies
(CCAB) in the United Kingdom.
 WHO TRS -908.
 Pharmaceutical Inspection Co-Operation Scheme 1 ,
September 2003
 SOP CQA-54 and QA-10
Case Study
Internal Audit