International Standards Certifications Pty. Ltd.

Report No

A.C.N. 071 810 949

Page No.

The Quality Centre, 16A, Loyalty Road, North Rocks, Sydney, NSW 2151, Australia

Audit
Date(s)

QAC/EMS/A91/094/0100
1

of

17 - 18 January 2000

INITIAL AUDIT REPORT

COMPANY:

Alembic Ltd

AUDITED

17-18 January 2000

SITE(S):

Alembic Road, Vadodora, Gujarat, India

STANDARD:
CLIENT:

ISO 14001:1996
As Above
SCOPE OF AUDIT / CAPABILITY:
The capability being sought was for the manufacture of Penicillin G and other pharmaceutical products
The audit scope was limited to the environmental management system in place at the organisations site in Vadodora.

Report By........Stan Rodgers.......................Signature.................................................Date.....

FORM 5 AUDREP 1
ISSUE 1 REV
2

Report No

International Standards Certifications Pty. Ltd.

A.C.N. 071 810 949

Page No.

The Quality Centre, 16A, Loyalty Road, North Rocks, Sydney, NSW 2151, Australia

Audit
Date(s)

Clause
ISO
9001 & 2

Clause Title

Clause
Status
*

General requirements

NA

4.2

Environmental policy

Mi

NCR 00/01

4.3

Planning

4.3.1

Environmental aspects

Ma

NCR 00/02

4.3.2

Legal and other requirements

Ma

NCR 00/03

4.3.3

Objectives and targets

NA

4.3.4

Environmental management programme

NA

of

17 - 18 January 2000

Implementation and Operation

4.4.1

Structure and responsibility

NA

4.4.2

Training, awareness and competence

NA

4.4.3

Communication

NA

4.4.4

Environmental management system

documentation

NA

4.4.5

Document control

NA

4.4.6

Operational control

Mi

NCR 00/04

4.4.7

Emergency preparedness and response

Mi

NCR 00/05

Checking and Corrective Action

NA

4.5

CAR / NCR #. & Status

4.1

4.4

QAC/EMS/A91/094/0100

4.5.1

Monitoring and measurement

Ma

4.5.2

Nonconformance and corrective and

preventive action

NA

4.5.3

Records

NA

4.5.4
4.6

Environmental management system audit

Management Review

Ma

* Clause Status:

= Satisfactory,

Ma = Major,

NCR 00/06

NCR 00/07

S
Mi = Minor,

N/A = Not audited fully

Comments

FORM 5 AUDREP 1
ISSUE 1 REV
2

International Standards Certifications Pty. Ltd.

Report No

A.C.N. 071 810 949

Page No.

The Quality Centre, 16A, Loyalty Road, North Rocks, Sydney, NSW 2151, Australia

Audit
Date(s)

QAC/EMS/A91/094/0100
3

of

17 - 18 January 2000

SUMMARY OF AUDIT
A Stage 1 audit of the Environmental Management System at Alembic Ltd was conducted on the above
date by International Standards Certifications in accordance with the requirements outlined in ISO
Standard 14010 and 14011. The objective of the audit was to review the organisations documentation,
identify any special issues requiring attention during the audit, provide feedback to the organisation and
agree with the organisation, details for the Stage 2 audit. The audit was confined to the Alembic Road
site and the associated effluent treatment plant on an adjacent site and the criteria used was that
contained in ISO 14001, Alembics environmental policy manual, procedures and work instructions.
The audit team consisted of Stan Rodgers acting as audit team leader and Bipin Rajadhyaksha, Kishor
Rajhansa and Priti Srikrishnan as audit team members.
The audit process involved interviews with the Senior Vice President H.D. Patel, Environmental
Management Representative, J.J. Chaudhuri; with respect to system documentation and other managers
with respect to the organisations operations. A brief tour of the facility which was located on three
distinct, but closely located, sites at which the manufacture of penicillin, ethrymicin and yeast took
place, the effluent treatment plant and a sludge storage site.
The audit findings resulting from the audit are as follows:
4.2
Environmental Policy (NCR 00/01)
The system does not ensure that the;
1. policy provides a firm commitment to pollution prevention.
2. policy demonstrates it is appropriate to the nature, scale and environmental impacts of the
organisations activities and or products
4.3
Planning
4.3.1 Environmental Aspects (NCR 00/02)
The system does not ensure that the;
1. organisations activities, products and or services have been adequately identified
2. associated aspects have not been adequately identified in terms of normal, abnormal and emergency
circumstances
3. method of determining the organisations environmental impacts is adequate, including the
identification of the site factors.
4. method of ranking the organisations impacts is soundly based.
5. procedures provide adequate guidance to enable the identification of its significant impacts and
aspects.
4.3.2 Legal and Other Requirements (NCR 00/03)
The system does not ensure that the;
1. process for identifying the relevant environmental legislative requirements and maintaining its
currency is clearly documented ie. The current list of legal requirements is not complete
Environment (Protection) Act 1986 and others are missing.
2. dissemination of such information is provided to those with the responsibility to act upon it.
4.4

Implementation and Operation

FORM 5 AUDREP 1
ISSUE 1 REV
2

International Standards Certifications Pty. Ltd.

Report No

A.C.N. 071 810 949

Page No.

The Quality Centre, 16A, Loyalty Road, North Rocks, Sydney, NSW 2151, Australia

Audit
Date(s)

QAC/EMS/A91/094/0100
4

of

17 - 18 January 2000

4.4.6 Operational Control (NCR 00/04)

The system does not ensure that:
1. all operations and activities that are associated with the organisations significant aspects are planned
and performed in accordance with specified conditions.
4.4.7 Emergency Preparedness and Response (NCR 00/05)
The system does not ensure that:
1. all emergency situations have been identified, procedures prepared for their management or the
mitigation of their impact in the event of an occurrence.
4.5
Checking and Corrective Action
4.5.1 Monitoring and Measurement (NCR 00/06)
The system does not ensure that:
1. compliance with relevant environmental legislative requirements is monitored effectively
4.5.4 Environmental Management System Audit (NCR 00/07)
The system does not ensure that:
1. the audit process or its outcome is effective, ie. procedures are not adequate, competence of the
audit team is not determined and the audit objectives, scope and criteria are not clearly identified.
Conclusion
The audit revealed that while the organisations senior and middle managers were very knowledgeable
with respect to the impacts created by their activities and the process by which these were derived this
information was not fully reflected in the contents of their policy and procedures manuals, associated
work instructions and records. In addition the process used to identify the organisations environmental
aspects and significant impacts was incomplete and not soundly based therefore the organisation was
unable to demonstrate that it had identified all the environmental aspects, significant impacts and
significant aspects associated with its operations. The absence of this information rendered the
remainder of the system not yet fully effective in managing its activities in accordance with the standard.
It was also noted that not all the relevant environmental laws had been identified and were being acted
upon and that the basis for monitoring and compliance with some of those laws was not sufficiently
rigorous to demonstrate compliance.
The internal audit process lacked procedural rigour in terms the determination of the audit objectives,
scope and criteria, process followed and the competence of the audit team and thus the degree of
reliance that could be placed on its outcome was very limited..
Alembic should be commended on its knowledge of the environmental issues associated with its
activities and its commitment to the implementation of an EMS and the work undertaken to date.
Recommendation

FORM 5 AUDREP 1
ISSUE 1 REV
2

International Standards Certifications Pty. Ltd.

Report No

A.C.N. 071 810 949

Page No.

The Quality Centre, 16A, Loyalty Road, North Rocks, Sydney, NSW 2151, Australia

Audit
Date(s)

QAC/EMS/A91/094/0100
5

of

17 - 18 January 2000

In view of the nature of the non conformities identified its is recommended that Alembic be subject to
another Stage 1 audit when these non conformities have been satisfactorily rectified.

Stan Rodgers
Lead EMS Auditor
International Standards Certifications

FORM 5 AUDREP 1
ISSUE 1 REV
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