DEPTT/

SECTION
COMPANY
WIDE

TITLE
INTERNAL AUDITING
RELATED CLAUSE
ISO 9001: 2008

DOCUMENT #
RP-SP/F-04

ISSUE DATE

ISSUE #.
01
PAGE #.

11-10-2012

1 OF 3

REVIEWED BY

APPROVED BY

PERFORMANCE EXPECTATION
Development and application of an effective auditing function which guides the executive management in
measuring the performance of QEMS Integrated Management Systems against the established Policies and
related procedures

PROCESS

Scheduling of Audit

Selection of Auditors

ACTIVITY
QCM/HRM plans and FM/MD approves
for plant and head
office the internal audit schedule on the basis of
a. Major activity in Ray Pharma
b. Implementation status in different sections.
c. Complaints from customers including those from regulatory
bodies
d. Internal failures, cGMP violations, excessive reworks etc
e. Safety, Health and Environmental Hazards of different
activities
f. Risk assessment and impact assessment for Quality &
Environment
g. Previous Audit Reports.

QCM/HRM ensures that atleast TWO complete audits are

planned during the year.
Audit schedule is mailed to auditors and auditee
Audit Checklist Preparation

Checklist specifies the questions to be asked, what

documents to look at, how many documents to look at and
what to look for in order to measure system/process
effectiveness and efficiency.

Audit Execution

Auditors execute the audit. During the audit, auditors ask

the questions, verify the records against the documented
system and look for effectiveness of the activity.

If the auditor fails to prove the raised nonconformity based on records, evidences etc then
no Corrective Action Request is raised and
compliance status is noted on the audit checklist.

Identification
of Non-Conformity

Raising
Corrective Action
Request

Auditors identify the non-conformity after verification

through objective evidence. Verification can be in the form
of records, statements etc.

Auditor writes the non-conformity on Audit Report.

Each non-conformity related to specific clause or document
is written on separate Audit Report.
Each non-conformity describes the area, date of audit,
reference clause/document and specific details of nonconformity such that it is traceable.
Auditor grades the non-conformity as Major, Minor or
Observation.
Auditor takes the acknowledgement of the auditee on Audit
Report .
Auditee provides corrective actions against the non
conformity and the target implementation date.

Determine new
corrective
actions and
target dates

Auditor submits Audit reports QCM/HRM.

QCM/HRM reviews the Audit report w.r.t.

o Practical implementation of action

o Strength of proposed action i.e. whether it can minimize
the effect of causes of non-conformity.
o Urgency to implement these actions.

Review of
corrective /
preventive
actions and their
target dates
Accept

Reject

QCM/HRM in consultation with concerned department

/section head documents the decision about acceptance of
corrective/preventive actions and follow-up dates.

QCM/HRM logs the proposed / reviewed

implementation dates and follow-up dates on log
sheet.

QCM/HRM communicates the revised

implementation actions and dates (if applicable) to
concerned areas responsible for implementation.

Login
of
Corrective Action Request

Implementation of Corrective Action

Concerned areas implement the actions by:

Training of staff
Updating documents.
Changing process/procedure.

Follow-up of Implemented
Corrective Action

Reject

Any person among the internal auditors will

be assigned by QCM/HRM to follow
implementation status of actions after the
follow-up date.

Assigned person reviews the effectiveness of

the implemented actions by:
Whether actions has been implemented as
documented.
Has these implemented actions are able to
reduce the impact of non-conformity.

Review of
effectivenes
s of
implemente
d actions

Concerned function fills the Audit Report and

submit to QCM/HRM

OK
Close-out of Audit
Report

END

QCM/HRM closes the AR and updates the

Audit log sheet.
QCM/HRM prepares the status summary report on
Audit Report status to present in Management
System Performance Review.

RELATED DOCUMENTS:
Audit Schedule
Audit Checklist
Audit Report
<END PROCEDURE>