Professional Documents
Culture Documents
TO
INTERNAL AUDITORS
Audit
Independence:
Auditor must be independent of the activity being
audited. They must remain free from bias and
conflicts of interest
Evidence:
Audit evidence must be verifiable and on sample
basis.
Types of Audits :
First Party : An audit by the organization of its
own systems and procedures.
(Internal Audit / Self inspection)
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 :
Disadvantages:
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.
Do not interrupt
Be Punctual
to auditee Don’t shout
2.0 Observation :
Observed the activity.
Don’t obstruct and don’t stare.
Techniques of Audits:
3.0 Interview :
Ask-open-ended question .
Results from the interview should be summarized and any findings should be
verified.
Packing
Batch records
RAW /Packing material
Dispatch RECEIPT
Dispensing
Deviation
Testing
Investigation
OOS/ OOT
CAPA
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
precisely.
Stress confidentiality.
Review on-line compliances if any.
Give recommendations for improvements
THANK THE AUDITEES
Self inspection
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
QA-101A25.
Internal audit
ANY QUESTIONS?