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Internal Audit Summary 2013

Three key points: 1) This is a self-inspection report from an internal audit conducted at PT Novo Nordisk Indonesia from March 21-25, 2013. 2) The audit identified several critical and major findings related to the quality management system and occupational health and safety management system. 3) The report provides an audit summary, findings, suggestions, and a list of audit findings to help PT Novo Nordisk Indonesia improve its processes and address any issues.

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51 views4 pages

Internal Audit Summary 2013

Three key points: 1) This is a self-inspection report from an internal audit conducted at PT Novo Nordisk Indonesia from March 21-25, 2013. 2) The audit identified several critical and major findings related to the quality management system and occupational health and safety management system. 3) The report provides an audit summary, findings, suggestions, and a list of audit findings to help PT Novo Nordisk Indonesia improve its processes and address any issues.

Uploaded by

erikaoktavianipurba
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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You are on page 1/ 4

FOR INTERNAL USE ONLY

SELF INSPECTION REPORT

Auditee: PT Novo Nordisk Indonesia

Audit date(s): 21-25 March 2013

Audit ID: 002-2013-AU/NNID

Representative from Quality Affiliates &


Marketing Support: NA

Audit team:
Lead Auditor: Felicia Fikri
Auditor(s):
Specialist(s):
Observer(s):
Trainee:

Auditee participants:
Title Name
Product Manager (BioPharm) BAIL
Product Manager (Insulin) YENO
Sales coordinator ESNA
Medical Affairs manager LKIM
Medical Advisor SLYI
HR Manager RWAK
Legal & Compliance Manager KUHR
IT Specialist SDQR
Logistic/Finance THYI

Distribution:

Lead Auditor: Date:

MHQ 2011-07-25 page 1 of 4


Conclusion

Good practices observed during the audit:


xx critical/major findings was/were issued to the Quality Management System:


yy critical/major findings was/were issued to the Novo Nordisk Occupational


Health & Safety Management System:

Status of the focus areas:


Due to the nature and duration of the audit, the findings found are the result of a
sampling process and therefore do not necessarily represent the full extent of the
findings.

The management responsible for the area being audited shall ensure that any
necessary corrections and corrective actions are taken without undue delay to
eliminate detected findings and their root causes.

Where relevant, the findings should be evaluated to determine general impact on


the appropriate areas.

A total of (x+y+z) findings was/were documented, x critical, y major and z


minor.

(v) suggestions has/have been issued. There will be no formal follow-up on these
but it is expected that the area take the suggestions into consideration for
continuous improvement of the quality system.

MHQ 2011-07-25 page 2 of 4


Table of contents

Audit plan

Audit purpose

Audit scope

Reference documents

Deliveries to Novo Nordisk

Description of the company

MHQ 2011-07-25 page 3 of 4


Audit summary

Follow-up on critical audit finding(s)

Good practices

Audit subjects with no comments


Suggestions
Suggestion x:

Findings
See finding no. y (Minor/Major/Critical).

Focus area

Good practices

Audit subjects with no comments


Suggestions
Suggestion x:

Findings
See finding no. y (Minor/Major/Critical).

Dept. name, dept. no.

Good practices

Audit subjects with no comments


Suggestions
Suggestion x:

Findings
See finding no. y (Minor/Major/Critical).

List of audit findings

MHQ 2011-07-25 page 4 of 4

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