Internal Audit Procedure
(QMS-ISPL-P-IAP)
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Version No |
V20 |
Prepared by |
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Date |
30-01-2015 |
Name |
Suman |
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Signature |
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Date |
30-01-2015 |
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Copy No |
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Approved by |
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Issued to |
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Name |
Sai Prasad Koneru |
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Signature |
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Date |
30-01-2015 |
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Document Amendment Record
A-
Added,
M- Modified, D- Deleted
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Sl.No |
Date |
Version No |
Page No |
Change Mode (A/M/D) |
Brief description of change |
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1 |
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V01 |
N/A |
A |
Initial Release |
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2 |
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V02 |
4 |
A |
Included description of the
quality calendar in the section 7.8 and reference of the quality calendar
(QMS-ISPL-R-QCL) in the section 9 |
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3 |
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V03 |
1-2 |
A |
Included the process for selection
of internal auditors |
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4 |
A |
Included the form for the list of
Internal auditors |
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4 |
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V04 |
N/A |
M |
Modification of the Non Conformance Report
form to include root cause, corrective action and other section |
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5 |
05-10-2007 |
VO5 |
N/A |
M |
Modification of the Non Conformance
Report form to change the date format |
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6 |
06-06-2012 |
V05 |
N/A |
D |
The Company address information is
removed from the Footer |
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7 |
30-01-2015 |
V20 |
N/A |
N/A |
Reviewed and base lined |
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Table of Contents
5 Entry criteria, Input, Activity, Output,
Exit criteria
7.5 Internal audit preparation
7.6 Corrective action and preventive action
8 Quality system documents referred
To implement and maintain a
procedure for planning and conducting internal audits and to assess whether the
quality system meets the requirements of the relevant QMS standards.
2 Objective
Internal audits are planned and
conducted to verify whether quality activities and related results comply with
planned arrangements to determine the effectiveness of the QMS.
3
Scope
Internal audits are conducted on all
the activities covered by the QMS of Inooga
Solutions.
4 Terms and definitions
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Abbreviations/Terms |
Description |
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ISPL |
Inooga Solutions Private Limited |
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QMS |
Quality Management System |
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MR |
Management Representative |
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QA |
Quality Assurance |
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NCR |
Non-Conformity Report |
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IA |
Internal Audit |
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NC |
Non Conformity |
5 Entry criteria, Input, Activity, Output, Exit criteria
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Sl.No |
Entry
Criteria |
Input |
Activity
|
Output |
Exit
Criteria |
|
1 |
Need
for Qualified Internal Quality Auditors |
Identification
of internal auditors to be trained |
Imparting
training to selected list of internal auditors |
Consolidated
list of qualified internal quality auditors |
Release
of list of internal auditors |
|
2 |
Need
for planning and scheduling |
Department/ Project
for audit. List
of internal auditors |
Internal
audit planning and scheduling |
Audit
plan and audit schedule Audit
calendar |
Release
of audit plan and schedule |
|
3 |
Audit
to be conducted |
Audit
plan and audit schedule |
Conduct
audit |
Audit
log and NC reports |
Completion
of audit |
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4 |
Need
for corrective actions |
NC
reports |
Corrective
action |
Corrective
action reported in the NC |
Implementation
of corrective action |
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5 |
Need
for follow up audits |
Corrective
action reported in the NC |
Follow
up audits |
Closure
of the NC |
Verification
of corrective action |
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6 |
Conduct
of Internal Audits |
NC
reports |
Management
reporting |
Summary
reports to Management review |
Discussion
in the management review |
6 Responsibility
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Sl.
No |
Activity
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Responsibility
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1 |
Internal
audit planning and scheduling |
Management
representative |
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2 |
Conduct
internal audits |
Internal
auditors |
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3 |
Corrective
action |
Auditees |
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4 |
Follow
up audits |
Internal
auditors |
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5 |
Management
reporting |
Management
representative |
7 Procedure description
Management representative prepares
the annual internal audit plan covering all the projects/departments. The plan
ensures that each area is audited at least once every three months. This is part
of the quality calendar maintained by the MR.
7.2 Audit selection criteria
Internal audits are conducted at
least once in a quarter. However, all projects should undergo audits at least
once in their life cycle. Projects that commence and are likely to get closed
between two audits cycle should be audited independently. The results of the
audits are added to the next audit cycle.
7.3 Internal audit schedules
Management Representative (MR)
prepares detailed audit schedule as per quality record format internal audit
schedule consisting of dates of audit, audit team, scope of audit and
applicable procedures, at least ten to fifteen (10-15) days prior to the audit
dates. The management in accordance with the needs of the quality system and
business activity may change the frequency of these audits. Reasons for the
postponement or cancellation of a scheduled audit shall be recorded. Auditors
chosen for the audits should be independent of the area being audited.
7.4 Audit team
The audit team consists of one or
more auditors. The number of auditors depends upon the scope of the audit. The
MR selects the auditors from each department. Internal quality auditors are
selected based on the relevant functional experience. Training is imparted to
the selected members on interpretation of the ISO 9001:2000 principles and
auditing concepts. Only qualified internal auditors are selected as internal
auditors, however members who have prior experience in this area may be
exempted from this training. The list of qualified internal auditors (QMS-ISPL-L-LIA)
is maintained by the MR and is updated on a quarterly basis.
7.5 Internal audit preparation
The following are provided to the
audit team:
Ø Quality management system documentation
Ø Internal audits- Non- conformity and corrective action
records of earlier audits
Ø The audit team prepares audit checklists for the areas to be
audited.
7.5.1
Opening meeting
Opening meeting is the first
activity in the audit cycle and is conducted by the MR. The management of the
company, auditees and the auditors attend the opening
meeting.
It covers the following:
Ø Scope of the audit cycle.
Ø
Logistics.
Ø Closing meeting schedule.
Ø Schedule for the closure of NCs.
7.5.2
Conducting internal audits
An audit should be considered a
constructive activity, where the main objective is to discover weakness in the
quality system. The auditors shall obtain objective evidence of implementation
and effectiveness of the quality system in terms of records/documents/messages
and check for traceability across the processes in the audit area.
As per the audits schedule, the
audit team visits the area to be audited and conducts the audit. During the
audit, the audit team examines whether the activities of the area are conducted
as per the approved process/procedure of the company. Some suggested methods
for conducting audits are as follows:
Ø Examine the documents and records of the area being audited.
Ø Interview the persons working in the area.
Ø Study the working methods and procedures followed
During the audit, the auditors collect
objective evidence to determine the effectiveness of the QMS. Non-compliance to
the QMS leads to non-conformity. The auditor notes the audit observation in an
internal audit log. All non–conformance are identified using the
non-conformance report form (QMS-ISPL-F-NCR).
The summary of the audit is recorded using the audit summary report form (QMS-ISPL-F-ISR).
7.5.3
Closing meeting
The MR conducts the closing meeting.
The participants are the same as those in the opening meeting. The MR
summarizes the audit finding and presents them to the audience. A summary of
the organization wide NCRs are also presented so that the project/activities
across the organization can take proper corrective action.
7.6 Corrective action and preventive action
The non-conformance report form will
be handed over to the auditees for identifying
corrective and preventive actions along with dates by which they will be
completed. These actions are discussed and agreed upon by the auditors. Agreed
corrective and preventive actions are entered into the NCR form and a copy of
this is provided to MR. The non-conformance is tracked to closure. MR ensures
that the concerned auditors verifies the corrective/preventive actions stated
in the non-conformance as stated in the non-conformance report and signs off
the NCR. During the implementation of the corrective action, change to product
or procedures (if required) are carried out by implementing the steps in the
change control procedure. Those NCs where implementation can be effected only
when the event reoccurs, corrective action on past events is not possible) and
which is not likely to happen before the next cycle of audits, may be closed on
a written assurance for future implementation by the auditees
in the NCR.
7.7 Follow-up audits
MR deputes one of audit team member
to conduct follow up audits to verify whether the corrective action has been
implemented effectively. The auditor closes the internal audit-NC report and
corrective action record and informs the MR accordingly. MR keeps track of the
internal audit NC report and corrective action record, which are closed and not
closed.
7.8 Management review
MR prepares internal audit summary
report as per quality record format IA summary report for management review and
submits the same as per the management review procedure.
The
annual plan of the Internal audits (once in 3 months),
SQA audits and the Management review meetings (at least once in three months)
are maintained in the Quality calendar by MR.
Work
Horse Tool
Work
Horse tool at Inooga Solutions can also be used for
preparation of audit schedule, NCR details, corrective and preventive actions,
audit summary report.
8 Quality system documents referred
Nil
9 Records
|
Sl.
No |
Required
Record |
Custodian |
Retention
Period |
Record
ID |
|
1.
|
Internal
Audit Schedule |
QA
Manager |
2
years |
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2.
|
Non
Conformance Report Form |
QA
Manager |
2
years |
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3.
|
Internal
Audit Log |
QA
Manager |
2
years |
|
|
4.
|
Internal
Audit Summary Report |
QA
Manager |
2
years |
|
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5.
|
Quality
Calendar |
MR |
2
Years |
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6. |
List
of Internal |
MR |
2
Years |