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DEPTT/

SECTION
COMPANY
WIDE

TITLE
CONTINUAL IMPROVEMENT
RELATED CLAUSE

ISO 9001: 2008

REVIEWED BY

DOCUMENT #
RP-SP/F-03
ISSUE DATE
11-10-2012
APPROVED BY

ISSUE #.
01
PAGE #.
1 OF 5

PERFORMANCE EXPECTATION
With a commitment and support from Managing Director and all the staff, a culture of continual
improvement of all critical business processes with the approach to manage the processes and
activities proactively to increase their efficiency and effectiveness in terms of Cost, Quality,
Productivity, Efficiency & Effectiveness, Product safety, Occupational Health & Safety and
regulatory compliance for Quality/cGMP and Environment.
EXPLANATION
This procedure defines the continual improvement system in two parts i.e. Preparation of
Objective Action Plans (Pro-active approach and part of Objective setting) and Raising of
Improvement Action Requests by the staff (Reactive / Accidents / Incidents / Non-Conforming
event Based Approach).
OBJECTIVE ACTION PLANS
After the end of the year, ALL departmental and Section Heads prepares the improvement plans/
departmental objective, the input for which is derived from
a. Quality and Environmental Policy and the Objectives/Goals
b. Targets / Objectives given by the MD/Board of Directors
c. Past year performance w.r.t. Customer Complaints, Quality Issues, Sales Growth,
Overhead Cost, Material Wastages Cost, Downtime Cost, Machine Downtimes %,
Operating cost, Environmental failures, Near Misses, Accidents / Incidents,
Injuries, Results of Environmental Aspects etc.
d. Business Plan for the next year
e. Process efficiency measurement through statistical techniques
f. Problems in cash flow management, raw materials timely availability, Product &
Service
Quality cGMP and Environmental issues etc.
g. Others

Before the preparation of plan, all section heads discusses the plan/idea verbally with their
concerned functional heads. After verbal approval, functional heads forwards the plan to
GM-Finance who calculates the cost associated with it (the implementation plan) and the
net saving in terms of cost.
(increase in sales, market share, profitability, Productivity
improvement, less reworking, less inspection/testing, less downtimes, less material
wastages, etc is also converted into cost).

GM-Finance forwards the plan to Managing Director for review and discussed in Monthly
Meetings before the finalization.

In case of approval /finalization of plan by MD, the Objective Action Plan is completed for
following parameters at different stages
a. Detail description of the plan.
b. Time frame for the completion
c. Background for the plan.
d. Designations responsible to workout the proposed actions.
e. Determining actions.
f. Designations responsible for the actions (to implement) and target time frame
for implementation.
g. Quantitative performance parameters

The Objective Action plan is reviewed atleast thrice during the complete time frame of plan.
The status of plan is documented during the different management review meetings by
respective section head.
In case of successful implementation of actions and achievement of desired goals, QCM
Manager at plant / HRM at Head Office and concerned area/section identifies the documents
(whether created or amended) so that the implemented actions can become the part of
Integrated Management System for consistent output.

IMPROVEMENT ACTION REQUESTS

PROCESS
START

INITIATION OF
IMPROVEMENT ACTION
REQUEST (IAR)

ACTIVITY
Anyone can raise the request for Improvement by
filling the IAR form.
IAR form is available through the company at
following locations
o Near Suggestion Boxes in all areas of
factory
o With Departmental / Section heads
o At Main Gate of Factory
o At Reception
IAR can be initiated on the basis of following
Re-occurring Non-Conformance of
o system or process, product.
o environmental system
o Health & Safety systems /controls.
o
cGMP including hygiene and
sanitization system and safety.
o Health and Safety risks for employees
o Health and Safety
accidents/incidents /near misses
o Environmental hazards risks
o Hazardous Material release above the
NEQS
Absence of system or ineffective system
Ideas which can enhance the
o process / activity efficiency,
o process / activity effectiveness,
o Product Quality
o customer satisfaction
o cost reduction (without decrease in
product quality, EHS Performance),

Customer Feedback

Problems encountered during the


manufacturing, sales and marketing

Resources identification
All IARs are forwarded to Factory

A
R
E
J
E
C
T/
H
O
L
D

REVIE
W OF
IAR

IAR ACCEPTED FOR


ACTION

SUBMIT IAR TO FM/MD

QCM/HRM in consultation with respective


department / section head reviews the IAR
on the basis of following.
Nature of non-conformity, critical or
major or minor and its impact on the
existing system.
Need to initiate action at this moment.
Has the initiated IAR contains the
substance which is relevant to Areva
activities
In case of Rejecting or Holding the IAR,
QCM/HRM writes the reason for rejection

In case of acceptance of IAR for action,


QCM/HRM informs to the initiator about the
acceptance of IAR.
Accepted IAR is entered into log sheet
QCM/HRM submits the IAR on monthly basis
to FM/MD during the plant/head office
meetings.
Those IARs which requires immediate
decision can be forwarded to FM/MD early

DECIDE WHO WILL


PERFORM
INVESTIGATION AND
PROPOSE
CORRECTIVE/PREVENTIV
E ACTIONS.

FM/MD in consultation with the concerned


department / section head during the
plant/head office meetings will decide who
will perform investigation and propose the
corrective/preventive actions.
After FM/MD decision, IAR is returned back
to QCM/HRM who after login it in log sheet,
forwards to respective area for investigation
of root cause (if applicable) and corrective /
preventive action determination.

INVESTIGATION OF
ROOT CAUSE (IF
APPLICABLE) AND
PROPOSING
CORRECTIVE/PREVENTIV
E ACTIONS

Concerned area/function investigates the


root cause of non-conformity.
Concerned area/Investigator proposes the
corrective/preventive actions and their
target implementation dates.
Concerned area /Investigator then returns
the IAR to QCM/HRM.

QCM/HRM in consultation with respective


section / department head reviews the IAR
w.r.t.
Practical implementation of action
Strength of proposed action i.e.
whether it can minimize the effect of
causes of non-conformity.
Urgency to implement these actions.
Resources required to implement the
corrective / preventive action.
Impact of corrective / preventive
action on documented system.

QCM/HRM logs the proposed / reviewed


implementation dates and follow-up dates
on IAR log sheet.
QCM/HRM communicates the revised / as
is implementation actions and dates (if
applicable)
to
concerned
areas
responsible for implementation, through a
copy of IAR.

REVIEW OF
PROPOSED
CORRECTIVE /
PREVENTIVE
ACTIONS AND
THEIR TARGET
DATES

RESPECTIVE
AREA AGAIN
PROPOSES THE
ACTIONS AND
DATES AND
SUBMITS TO
QCM/HRM

IN CASE OF
REJECTION OF
(IAR)

ACCEPTANCE OF
(IAR)

LOGIN OF
(IAR)

Concerned areas implement the actions


by:
Training of staff
Updating documents.
Changing process/procedure.
Acquisition of resources

Any function (preferably from Internal


Auditors) is assigned by QCM/HRM to
follow implementation status of actions.

IMPLEMENTATION OF
ACTION

FOLLOW UP OF
IMPLEMENTED
ACTION

REVIEW OF
EFFECTIVENE
SS OF
IMPLEMENTE
D ACTIONS

(IAR) STATUS
OPEN

(IAR) STATUS
CLOSED

CLOSE-OUT
OF (IAR)
If IAR status is open due to weak or poor
or no implementation or due to absence
of effectiveness of implemented actions,
assigned functions will advice the
concerned area to amend the actions or
look
into
the
reasons
of
poor
implementation
or
ineffective
implementation. IAR will remain open till
the implementation is executed as per
approved corrective/preventive action.

Assigned person(preferably from Internal


Auditors) after the follow-up date 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 nonconformity.
Assigned person fills the IAR and submit to
QCM/HRM
In case if the concerned area fails to
implement the agreed corrective
actions
with
the
target
implementation
date
or
if
the
implemented corrective actions fails to
bring any
effectiveness, then the
auditor will not close the IAR and
Assigned designation closes the IAR, submit
to QCM/HRM and updates the IAR log
sheet.
QCM/HRM prepares the summary report on
IAR status to present in plant/head office
meetings.
RELATED FORMS
1. Objective Action Plans
2. Improvement Action Request
3. Log Sheet

END

END OF PROCEDURE

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