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QUALITY ASSURANCE

Ultra International Limited

Sahibabad Plant

STANDARD OPERATING PROCEDURE


MANAGEMENT SYSTEM MANUAL
Doc. No.
IMSM-01

Version
01

Effective Date

Replaces Version

Dated

Page
1

Total pages
23

Appendices
-

Works:
M/S COMPANY NAME.
64/01,Site-64/01,Site-IV,Sahibabad
Industrial area,Ghaziabad,(U.P)

MANAGEMENT SYSTEM MANUAL


MANAGEMENT SYSTEM
ISSUE NO
DATE OF ISSUE
TOTAL PAGES
CONTROLLED COPY NO:

Prepared by :

Approved by :

ISO9001:2008
1.00
01-06-2009
70 pages
01 Certifying Body

Released by :

Checked by :
Distribution :
This document is the property of Ultra International Limited. It must be handled confidentially and must not be copied or reproduced, in whole or in
part, in any way without explicit permission of the company.

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE

INTEGRATED MANAGEMENT SYSTEM MANUAL


Doc. No.

Version

IMSM-01

01

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Appendices

23

MANAGEMENT SYSTEM MANUAL


Prepared and
Issued by

Approved By

Md. Asif Ali

Mr. P. Mazumdar

Management
Representative
01-06-2009

Director
01-06-2009

Signature
Name
Designation
Date

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE
MANAGEMENT SYSTEM MANUAL

Doc. No.

Version

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01

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TITLE: INDEX
SECTION NO.

DESCRIPTION

ISO
9001: 2008
Clause

IMSM 0.1

INDEX

IMSM 0.2

INTRODUCTION & REVISION SHEET

IMSM 0.3

SCOPE OF MANGEMENT SYSTEM

IMSM 0.4

LIST OF CONTROLLED COPY HOLDER

4.0
-

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE

INTEGRATED MANAGEMENT SYSTEM MANUAL


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IMSM 1.0

MANAGEMENT SYSTEM GENERAL REQUIREMENTS

4.1

IMSM 1.1

IMS DOCUMENTATION REQUIREMENTS - GENERAL

4.2.1

IMSM 1.2

QUALITY MANUAL

4.2.2

IMSM 1.3

CONTROL DOCUMENTS

4.2.3

IMSM 1.4

CONTROL RECORDS

4.2.4

IMSM 2.1

MANAGEMENT COMMITMENT

5.1

IMSM 2.2

CUSTOMER FOCUS

5.2

IMSM 2.3

INTEGRATED POLICY

5.3

IMSM 2.4

INTEGARTED OBJECTIVES

5.4.1

IMSM 2.5

IMS PLANNING

5.4.2

IMSM 2.6

ORGANIZATION CHART AND INTERFACE

IMSM 2.7

RESPONSIBILITY AND AUTHORITY

5.5 7 5.5.1

IMSM 2.8

MANAGEMENT REPRESENTATIVE

5.5.2

IMSM 2.9

INTERNAL COMMUNICATION

5.5.3

IMSM 2.10

MANAGEMENT REVIEW

IMSM 3.1

HUMAN RESOURCES

6.1, 6.2

IMSM 3.2

INFRASTRUCTURE AND WORK ENVIRONMENT

6.3, 6.4

IMSM 4.1

PLANNING OF PRODUCT REALIZATION

7.1

IMSM 4.2

CUSTOMER RELATED PROCESS

7.2

IMSM 4.3

DESIGN & DEVELOPMENT

7.3

IMSM 4.4

PURCHASING

7.4

IMSM 4.5

PRODUCTION AND SERVICE PROVISION

7.5.1,2 & 8.2.3

IMSM 4.6

VALIDATION OF PROCESS AND SERVICE

7.5

IMSM 4.7

IDENTIFCATION AND TRACEABILITY

7.5.3

IMSM 4.8

CUTOMER PROPERTY

7.5.4

IMSM 4.9

PRESERVATION OF PRODUCT

7.5.5

IMSM 4.10

CONTROL OF MONITERING AND MEASURING DEVICE

5.5

5.6

7.6

TITLE: INDEX
SECTION No.

DESCRIPTION

ISO
9001: 2008
Clause

IMSM 5.1

MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1

IMSM 5.2

CUTOMER SATISFECTION

8.2.1

IMSM 5.3

INTERNAL AUIDT

8.2.2

IMSM 5.4

MEASUREMENT AND MONITERING OF PROCESESS

8.2.3

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE
MANAGEMENT SYSTEM MANUAL

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IMSM 5.5

MONITERING AND MEASURING OF PRODUCT

8.2.4

IMSM 5.6

CONTROL OF NON CONFORMING PRODUCT

8.3

IMSM 5.7

ANALYSIS OF DATA

8.4

IMSM 5.8

CONTINUAL IMPROVEMENT

8.5.1

IMSM 5.9

CORRECTIVE ACTION

8.5.2

IMSM 5.10

PREVENTIVE ACTION

8.5.3

LEVEL-II, III, IV DOCUMENTS


ANNEX-A

LIST OF QUALITY PROCEDURES

LEVEL-II

ANNEX-B

LIST OF EXIHIBITS

LEVEL-II

ANNEX-C

LIST OF SOP/WIS

LEVEL-III

ANNEX-D

LIST OF QUALITY RECRODS

LEVEL-IV

DOCUMENT REVISION SHEET


DOCUMENT
NO:

ISSUE/REV.
NO

DATE

QM :01

1.0

1-04-04

QM:01

1.0

01-06-09

BRIEF DESCRIPTION OF
CHANGE

Initial issue of QM for ISO


9001:2008 QMS
First issue of MS align with
ISO 9001:2008

APPROVED BY

CEO/Director
CEO/Director

INTRODUCTION OF ORGANISATION:
Ultra International Limited are manufacturers of flavour compounds, Essential Oils, Aromatherapy
Oils, Perfumery Compounds strictly adhering to International regulatory affairs and following IFRA
Guidelines. We have fully equipped modern R&D laboratories duly recognized by the department of
Science & Technology, Government of India since 1991 and are certified ISO 9001:2008.Also we
have individual application laboratories for Fragrances and Flavours.
0.4.1
1.
2.
3.
4.
5.
6.

CUSTOMERS :
Dabur India Ltd.
Zydus Cadila Healthcare
Johnson & Johnson Ltd.
Wyeth Ltd
Pepisco Ltd.
Cabin Kare Pvt. Ltd.

SCOPE OF CERTIFICATION:
Scope of this INTEGARTED MANAGEMENT SYSTEM MANUAL covers the Integrated Quality
Management System, as per ISO 9001: 2008, in Ultra International Ltd-Sahibabad for Manufacture
of fragrances & flavours, perfumery compounds, essential oil & aromatic compounds
Exclusion of clause/s

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE

INTEGRATED MANAGEMENT SYSTEM MANUAL


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ISO 9001:2008 Cl 7.5.2 (TITLE: VALIDATION OF PROCESS FOR PRODUCT AND


SERVICE PROVSION :)
In our product manufacturing we have no special process which quality criteria apparently not
determined during product realization and need to validation of the process. There fore this clause is
not applicable to our IMS requirement and it is address as Exclusion
Products:
Fragrances & flavours, perfumery compounds, essential oil & aromatic compounds.
TITLE: LIST OF CONTROLLED COPY HOLDERS
The Holders of this Manual are:
Type
Medium of Document

Copy Holder

Master Copy

In a Hard Copy

Management Representative

Controlled Copy No. 1

In a Hard Copy

Managing Director

Controlled Copy No. 1

In a Soft Copy

Certifying Body

TITLE; GENERAL REQUIREMENT


Following are the processes involved in the Integrated Management Systems installed by us,
Core processes:
Manufacturing, Marketing, Purchase, Store, Quality control, packing & Dispatch
Management related processes:
Resource management processes: Risk analysis Internal Quality Audit, Management Review,
Training, CA & PA Measurement, Analysis & Improvement processes,
Miscellaneous processes: Servicing of customer property, Maintenance, Interactions with sequence
of these processes are as defined in IMSM: 2.6. Overall order execution processes for the purchase
products are described in Annexure A. The Criteria & methods needed to ensure that the operation
and control of these processes are effective, is determined and the inputs for each process, and
associated activity and outputs in a measurable criteria are clearly defined in the flowcharts.
Necessary resources & information are provided at each stage to support the operation and
monitoring these processes. The data generated through measurements at various stages are analyzed
for corrective & preventive actions as appropriately.The actions decided are implemented to achieve
planned results. Continual improvements of the processes are carried out as necessary from time to
time.
At present we are not using any out process, if in case in future it is require than ensure all necessary
quality and environmental aspects where organization is responsible to deliver to his customer.
TITLE :IMS DOCUMENTATION REQUIREMENTS GENERAL
The organizations Quality Management System is documented in five tired, which covers the entire
processes and scope for which registration is sought.
INTEGRATED MGT SYSTEM MANUAL (IMSM) The apex document contains the IQM Policy, outline of INTEGATED Quality Management Systems
and objectives of the management. (Refer IQMM 1.2)

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE
MANAGEMENT SYSTEM MANUAL

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INTEGRATED MGT. SYSTEM PROCEDURE (IMSP) / FLOW CHART (CH)


This is a second level document, which contains the IQMS basic procedures in details as per
ISO 9001: 2008 standard requirement & other major processes in the Flow Chart form. Control
which This IIIrd level documentation is prepared by departmental Head and approved by M/s Ultra
International Ltd. Release of any document controlled by master list of the documents is maintained
by MR. MR controls the issue and revision also.The methodology of numbering system for WI, OCI
is serial in accordance with the clause numbers of the ISO 9001: 2008 Standard. The methodology of
numbering system for Flow Charts / SOP is as follows
TITLE: IMS DOCUMENTATION REQUIREMENTS GENERAL
[A] WI / SOP / Exhibits / OCI abbreviation followed by,
[B] Flow Chart / Standard operating procedure related to department code followed by,
[C] Serial Number in the Dept. 1,2,3 etc.
e.g. E/QCD/01 is the flow chart number 1 in Quality Control Department
WI/PUR/01 is the Work instruction number 1 in Purchase Department, SOP/MNT/01 Standard
operating procedure for maintenance dept number 1
FORMATS ( FR ) / LISTS ( LS ) / REGISTERS ( REG )
These are IVth level documents intended to provide evidence of the activity performed and also to
ensure effective planning, operation & control of the IQMS processes. Formats are prepared by
incharge, approved by HOD and issue is controlled by MR. A specimen master copy is kept with MR
for control, approval issue and changes. The methodology of numbering system for these documents
is similar to that of Flow Charts e.g. F/QCD/01 is the format number 1 in Quality Control
Department. Raising the revision number numerically following the document change procedure
makes the revisions to the work procedure and formats or access of current revision of the format no,
issue, rev and dt. of effective is written beneath of the forms or top of the format.
FORMATS (F) / LISTS (LS) / REGISTERS (FR)
These are Fourth level documents intended to provide evidence of the activity performed regarding
IMSM and as also to ensure effective planning, operation & control of the IMS processes.
Formats are prepared by IC, approved and issued by MR.
A specimen copy is kept with MR for control, approval issue and changes.
The methodology of numbering system for these documents is similar to that of Flow Charts
e.g. F/QCD/01 is the format number 1 in Quality Control Department
Raising the revision number numerically following the Document Change Procedure makes the
revisions to the work procedure and formats.
This four level document system is supported by document like Customer Drawing / Specification,
Quality Plans, Raw material specifications, National/ International Standards Etc.
Their details are referred to in QP / Exhibit manual wherever appropriate.
Abbreviations used are as follows :
CEO
Chief Executive

MKT
Marketing

MR
Management

QCD
Quality

IMSM
Integrated Mgt System
Manual
IMS:
Integrated

LB:
Label
LS:
List

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE

INTEGRATED MANAGEMENT SYSTEM MANUAL


Doc. No.

Version

IMSM-01

01

Representative
IC
In charge
ASST
Assistant
Opt
Operator
Supr.
Supervisor

Effective Date

Replaces Version

Control
Department
PUR
Purchase
PACK
STR
Stores
Dis
Dispatch

Packing

Dated

Management
System
WI
Works Instruction
QP
Quality Procedure
F
Formats
Mnt:
Maintenance

Page

Total pages

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23

EMP:
Environment
Management
Programme
E
Exhibit
QP
Quality plan
REG
Register
CS
Customers Spcn

TITLE: INTEGRATED MANGEMENT SYSTEM MANUAL


The Ist.54 level apex document is Integrated Management System Manual (IMSM); it is prepared by
MR and approved by Director
MR is responsible to control the Quality manual. The apex document contains the Quality Policy,
outline of Integrated Quality Management System as per ISO 9001:2008; and objectives of the
Management. It also defines responsibilities and authorities of various employees, management
executives related to quality activities. It gives the details of various processes and its sequence and
interaction. It also specifies controls over these processes with reference to related work procedures.
Every document of Quality Manual is given a unique number.
Director reviews the Quality Mgt System Manual during Management Review Meeting to assess
continuity, adequacy and conformity to customer requirements. Any staff of Ultra International Ltd
who wants to make any change to IMSM communicates it on Document Change Request Note
(DCRN) to MR. If approved by CEO, necessary changes are made. Revisions are identified
numerically. Whenever any page of document is revised, the whole document is revised to next
revision. Brief description of revision is given on Revision Status sheet. After nine revisions of any
document, issue of entire manual is raised to next issue number and for next issue no., revision
becomes ZERO for all the documents contained within it. Identified by highlighting the number
on IMSM-0.4. MR may take additional copies for the copyholder.
TITLE: INTEGRATED MANGEMENT SYSTEM MANUAL
MR maintains Master copy of Quality Manual, top page of which bears a stamp Master- Copy.
MR takes photocopy of this Master Copy and sends it to controlled copy holder after
Stamping its top page with stamp Controlled copy (Only Blue color). MR sends controlled copy
to certifying Body under covering letter.
Uncontrolled copy with a stamp as Reference Copy , MR can issue with permission from Director
only, the uncontrolled copy no updating services are provided.
Master Copies of invalid / Obsolete documents are either destroyed or kept with the stamp Obsolete
Copy, whenever required. All other photocopies are promptly destroyed by copyholders.
INTEGRATED MANGEMENT SYSTEM MANUAL is reviewed every twelve months for
interlinking of clauses.

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE
MANAGEMENT SYSTEM MANUAL

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TITLE: CONTROL OF DOCUMENTS


M.R is primary responsible for maintain and keep control over document approval, issue and
changes. Respective works head/In-charges are prepared the documents of IInd, IIIrd and IVth level
and approved by M.R.
Following are the documents :
1 Quality Policy
2 Quality Objectives
3 Quality Management System Manual (MSM)
4 Quality Management System Procedures (QMSP)
5 Work -Operation control Instruction (W&OCI)
6 Standard operating procedures (SOP) &
7 Technical Standing Order (TSO)/Material Safety Data sheet (MSDS)
8 Product Documents (Exhibit)
9 Testing Specification Technical Specification, Calibration Certificate
10 National / International Standards
11 Statutory and Regulatory Laws
12 Catalogues / Brochures
Quality Record and Formats:
Authorized persons as given above first approve the adequacy of the document to be issued. The tier
I & tier II documents like quality manual, quality procedures, work instructions, OCI SOP is signed
only on the revision sheet (IMSM-1.0) for approval for the original issue as well as for each change
thereafter. A master list and revision sheet is prepared. Identifying issue and revision of the
document. It is ensured that the latest issues of documents are available at the locations where
quality operations concerning them are performed. The responsibility for this activity is with
respective controlled copyholder and MR also verifies this during internal quality audits.
TITLE: CONTROL OF DOCUMENTS
It is ensured that the documents are legible and identifiable with unique numbers.
External documents like National / International Standards and Customer specification / Technical
Specification / calibration and Test Certificates are also controlled. Computerized and hard copies
Formats are controlled by master list to ensure that pertinent latest formats are use at the respective
department. M.R. is also ensure that Organization use latest version of National/International
standard applicable to product quality
The obsolete standard, manual, book is destroyed or kept with stamp Obsolete Copy On first and
last page, after issue is procured. Data maintained on computer is protected with password and virus
controlled system. Backup is maintained for retrieval in case of deletion of any data.
Data maintained in electronic form on computer is protected with password and Backup is
maintained. Changes in documents and data are reviewed by the same functions / authority which
Performs original review and approval. The sources for initiating document change are :
[A]
Document Changes Request Note (DCRN)
[B]
NCRs in internal / external audits

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE

INTEGRATED MANAGEMENT SYSTEM MANUAL


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Management Review Meeting

Obsolete document are removed and Master Copy is kept with Obsolete Copy stamp are clearly
identified and marked as Obsolete.Amendments and changes / revisions in internal documents are
made as soon as received from customer / National / international standard Bodies / Government
Bodies wherever required. All controlled copyholders are destroy earlier revision / issue after receipt
of latest revision / issue. The Obsolete documents retained for legal or reference purpose
MR maintains department wise list of documents with the revision status.
Reference Document : IMSP / IMS / 01 Procedure for document and data control
TITLE :CONTROL OF RECORDS
Primary responsibility for this function is with MR / respective in charge/HODS.
Records are maintained to demonstrate conformance to the specified requirements of Quality
Management Systems.
Work Procedure is laid down to give details of identification, protection, indexing, access,
filing, location, storage, retention and disposal of records.
A label, indicating above details is put on records. This also helps to ensure that records are
retrievable when required. It is ensured that records are legible & well protected & maintained during
its retention period. Where agreed contractually, records are made available to customer for the
evaluation. Records maintained on computer are protected with password, virus control system and
their regular back up is maintained.
Reference Doc.: IMSP/IMS/02 Procedure for control of Quality records.
TITLE: MANAGEMENT COMMITMENT
The top management of Ultra International Ltd is committed for development & implementation,
maintain and continually improving of Quality Management Systems as per ISO 9001:2008.
Director, MR and all staff are responsible for co-ordination of these activities. They have shown their
commitment for the Quality Management System by following ways.
1)
Fulfill of all requirements for Interested Party ,Stack holder and Customer,
2)
Follows Legal ,statutory and regulatory requirements,
3)
Use, & Manufacture Safe and Eco friendly Product.
4)
During process respect National/Internal standards of environment and health safety.
5)
The importance of the above requirements are communicated throughout the organization
by :
I
Conducting various formal / informal training sessions to cover all the employees.
II
Display and / or distribution of product specification / QP /OCI at pertinent Locations & its
use during product realization process.
6)
Establishing IQM Quality of the organization & ensuring its communication to all relevant
persons by various means as documented in IMSM-2.3
7)
Establishing the organization level as well as Process / Department Level IQMS Objectives
derived from IQMS Policy in order to achieve it.
8)
Ensuring effective implementation of Quality Management System by conducting
Management reviews.
9)
Ensuring the availability of adequate resources.

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE
MANAGEMENT SYSTEM MANUAL

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TITLE : CUSTOMER FOCUS


Marketing department (MKT) co-ordinates with the customer for getting the customer requirements.
These are met by supplying products are required as per customers need stated and unstated both.
Customer satisfaction level is monitored by the following methods and suitable corrective actions
are taken to improve customer satisfaction :
1)
Tracking number of new customers added
2)
Tracking customer complaints
3)
Tracking pending or completed orders
4)
Tracking timely deliveries
5)
Getting customer satisfaction feedback regularly and work out customer satisfaction index.
To know customer satisfaction level minimum once a year satisfaction survey to be conducted by
sending customer feed back form through mail,e-mail,or telephonically and work out for customer
satisfaction Index
TITLE : MANAGEMENT SYSTEM POLICY
We at Ultra International Ltd Management and employees are committed to provide a quality and on
time delivery in our
Communication and feedback :
This policy is explained to all relevant employees during various training programs conducted. This
policy is displayed at various places in the organization.
Quality Policy & Quality objectives (derived from Quality Policy) are reviewed in every
management review meeting for continuing suitability
TITLE : INTEGRATED MANAGEMENT OBJECTIVE
Further break-up of above objectives at departmental / process level. Along with their measurement
indicators is shown in Annex-A. Process approach charts

Date: 01 July 2009

Chief Executive Officer/Director

TITLE : MANAGEMENT SYSTEM PLANNING


The management system planning includes all processes as applicable for our organization. Detail of
it, is given in IMSM 1.0. Linking of these processes is clearly defined in IMSM 2.6 of this manual.
The responsibility for each process and the methodology for monitoring and measurement of these
processes are clearly defined. It is ensured that the integrity of process is maintained even when a
part it undergoes a change or modification. Suitable changes in other related processes or its parts are
planned and implemented to maintain the integrity of the process.
.
Ref : 1) IMSP/IMS/08- Identification, compliance, asses and update the legal and other
Requirements
TITLE: Objectives, Targets and Programme(s)
For setting and review of objectives and targets, a procedure has been established which are
consistent with the organizations technological options, financial, operational requirements and
views of interested parties.

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE

INTEGRATED MANAGEMENT SYSTEM MANUAL


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TITLE : RESPONSIBILITY AND AUTHORITY :


1. Director
2. Management Representative
3. Concerned QU In-Charge
4. QC/QA In-charge
Q U/Prod INCHARGES: Responsible/ authorized for :
i) Implementation and awareness of Quality policy in QUs under his control
ii) Responsible for implementing relevant Quality system procedure and operational control
instructions in QUs under his control
iii) Identifying and following applicable legal and other regulatory norms in QUs under his control
TITLE: RESPONSIBILITY AND AUTHORITY
Chemist/QC I/ch: responsible /Authorized for
i) Implementation and awareness of Quality policy in QUs under his control
ii) Responsible for implementing relevant Quality system procedure and operational control
instructions in QUs under his control
iii) Identifying and following applicable legal and other regulatory norms in QUs under his control
iv) Conservation of natural resources by effective monitoring
TITLE: MANAGEMENT REPRESENTATIVE
Mohd. Asif Ali has been appointed as Management Representative for ISO 9001-2008
In addition to his responsibility as Sr. Manager (General) and their routine duty, He is;
1. Responsible for ensuring that the processes needed for the Management System (MS) is
established, implemented and maintained in accordance with the International standards.
2. Responsible for reporting on the performance of the Quality Management Systems to the top
Management during the management system review meeting (MRM) on the basis of
planned/targeted QM (Quality) objectives.
3. He is responsible for promotion of awareness of customer requirements, interested party and
stack holder of the process through out the organization
4. He is also responsible for liaison with external parties for matters relating to the Quality
Management Systems.
5. For above activities, he is directly reporting to the undersigned.
6. Having all necessary authority to achieving Organization Goal.
Date: 01 July 2009

Chief Executive officer/ Director

TITLE: INTERNAL COMMUNICATION


Various methods of communication of information within the organization are as follows :
Display the quality objectives, MRM, Work Procedure, operation control instruction (OCI) Quality
Objectives data Sheet, Purchase Orders, Marketing Plans, and Customer approved specifications /
Specification, office memo / fax / e-mail / telephone.

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE
MANAGEMENT SYSTEM MANUAL

Doc. No.

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IMSM-01

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Above methods of communication are used by the persons concerned to ensure that communication
is effective. The results are monitored in terms of achievements of objectives set for each process and
the effectiveness of Quality Management System is monitored and communicated through results of
internal Quality Audits & Management Reviews.
TITLE: MANAGEMENT REVIEW
Director reviews the continuing suitability and effectiveness of Quality Management System. In
management review meeting held once in a six months.
The input for management review meeting is :
(1) Follow up actions review of previous minutes of meeting.
(2) Review of quality policy and effectiveness of quality objectives.
(3) Result of internal quality audits & corrective actions on non-conformities in system audits.
(4) Corrective actions on process performance and product conformity including deviations.
(5) Corrective actions on customer feedback.
(6) Records of preventative and corrective actions.
(7) Recommendations for improvements.
(8) Review of resources.
(9) Any other quality related issues, which can affect the quality management system.
MR arranges management review meeting by issuing a circular. This meeting is presided over by
Director and all Department Heads and Section Heads attend this meeting
The output of management review meeting mainly consists of
1.
Improvement of effectiveness of the Quality Management System and its processes.
2.
Improvements of processes
3.
Improvement of product related to customer requirements.
4.
Resource needs.
MR prepares the minutes of the meeting, which are approved by CEO
MR circulates a copy of the minutes of Management Review Meeting to concern I/c.
Retention period of minutes of Management Review meeting is 3 years
Ref Docs: - IMSP/IMS/03

Procedure for management review

TITLE: PROVISION OF RESOURCES


ULTRA INTERNATIONAL LTD has full capabilities to meet customer requirements and to enhance
satisfaction in terms of quality.
Adequacies of these resources are reviewed during;

Special Customer requirement for product realization

Management review

Contract review

Internal Quality Audit

Customer complaints review

New Design& Development of the Product

QUALITY ASSURANCE

Company Name

Sahibabad Plant
STANDARD OPERATING PROCEDURE

INTEGRATED MANAGEMENT SYSTEM MANUAL


Doc. No.

Version

IMSM-01

01

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TITLE: HUMAN RESOURCES


The organization has a motivated team of employees. They are given periodical training depending
upon the competence and awareness needs identified by respective department I/C. They are also
made aware of their role in achieving quality objectives.
Various areas of training identified consist of technical training as well as other aspects like quality
awareness, communication skills, attitudinal training etc. The organization has trained the staff
members to carry out the Internal Audit of the quality Management System.
Appropriate flow chart is laid down along with necessary formats to identify competency needs, skill
needed, educational background, experience etc. suitable planning of training activities and
implementation of training programs and verification of the training imparted are also documented
through these formats. Effectiveness of training and awareness is reviewed at appropriate intervals.
Persons performing specific assigned tasks are trained on the basis of appropriate education, skill or
experience, as required to make them aware of the relevance and importance of their activities and
their contribution in achieving the quality objectives.
Records of education, skill, -competence evaluation, working experience and training are maintained.
Cross-reference : IMSP/TRG/01 Procedure for Training
TITLE: INFRASTUCTURE
The organization has adequate infrastructure viz. space and material handling equipments and related
Product confirmation, Hardware and soft ware in computer as well as inspection & testing facilities
(refer IMSM- 0.3) to meet customer requirements. Adequate maintenance processes including
preventive maintenance as well as enough stand-by of machines and spares for manufacturing are
available in case of the breakdown takes place.
TITLE: WORK ENVIROMENT
All departmental head and Dy M.R s are responsible to maintain appropriate work environment and
follow necessary safety rules.
The work environment considering housekeeping, safety, personal, EHS (Essential Health &Safety)
cleanliness etc. is adequately provided & maintained. Safety, first aid and housekeeping are suitably
addressed. It is handled by MR.& Dy M.R, the fire extinguishers; first aid boxes are provided and
maintained by respective production incharge.wherever necessary. These are maintained and records
are documented adequate ventilation, protective cloths / aprons / caps / gloves / foot wares /
masks/goggles etc are provided & the work force is well trained for the use to it.
Work instructions as well operational control instructions at every critical process; operations of
machines plants are displayed.
TITLE: PLANNING OF PRODUCT REALIZATION
Planning for product realization is the primary responsibility of production incharge and QA incharge
on present products viz. conc. chemicals, industrial and decorative pints, resins etc. It ensures all
details of planning for product realization as well as Quality Objectives Preparation of Quality Plans,

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requirements of Material specification, Material Safety data sheet (MSDS), Competence of Supplier
is ensured and executed by Work head and Product Inspectors (QC, I/Ch)
Whenever a new product is launched, the customer requirement / product specification is analyzed &
requirement regarding equipment, processes, documents etc are identified. The planning also includes
verification, inspection, test activities, and conforming of MSDS specific to the product and the
criteria for product acceptance.
Records needed to provide evidence that the realization processes and resulting product meets
requirements and are established, maintained and periodically verified.
Ref: Master List of W&OCI
TITLE: CUSTOMER RELATED PROCESSES
Customer related processes are primarily the responsibility of Marketing Dept. which deals with
receipt of customers enquiries and reviews & determines the requirements of the product including
those requirements, which are not stated and also the statutory or regulatory requirements, as
applicable as well as the requirements for delivery and post delivery activities. This is done in
association with other departments like Purchase, Store and Production, if any and then tender or
order is accepted.
Pre & post Order or tender/contract reviews are made. The orders / tenders are reviewed with respect
to quotation for the technical feasibility and ability of manufacturing as well as other aspects like
price, delivery, and commercial terms by communicated to customer by IC (MKT).
All ambiguities and doubts are resolved with the customer at the time of acceptance of order and
communicate order confirmation
It is ensured that all verbal instruction received from the customer is discussed with the customer and
bilateral agreement prior to the execution of the order and are recorded
Provision is made in contract review to identify the regulatory requirements of our product in the
country of use.
Contact is maintained with the customer for any other details, which are found incomplete, or to
obtain feedback, to fulfill customers requirements. CEO/ IC (MKT) acts as channel of
communication. Amendments to the orders are recorded and pass on the persons responsible for the
execution of these amendments. The catalogues or advertising material, which are maintained by the
organization, are reviewed and controlled to ensure that they give the latest details.
Quality Records of review and related activities are maintained
Cross-reference: IMSP/MKT/01

Procedure for Contract review

TITLE: DESIGN AND DEVLOPMENT:


Design and Development of new product or review the Existing Products for Alternation, cost
reduction are to be done by Design and Development Department and CEO Design is over allresponsible for this element, and Methodology of Design Process is to be carried out as follows:
Design Input
Design input requirements relating to the product are identified, documented and their selection is
reviewed for adequacy.

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Contract review documents are considered for design input.


Applicable statutory requirements are also identified, documented and reviewed.
Customers Suggestion during feed back
Internal review and FMEA analysis

Design Output
Design output is documented and expressed in terms that can be verified and validated against design
input requirements.It is ensured that design output meets the design input requirements and contains
acceptance criteria for characteristics crucial to the safe and proper performance of the product.
For development product, product brief becomes design output.
Design output is reviewed before release. Design In-charge maintains necessary records and relevant
documents.
Reference: IMSP/DSN/01: Quality Procedure for design
Design Review
Stages of formal design reviews are carried out at as described in D & D plan. Where required
experts are invited and results of reviews are documented.
Design Verification
Testing the product at final stage against design out put does design verification and it is ensured that
test are meeting design input requirements.
Design Validation
Design validation is performed to ensure that product conforms to defined user needs and/or
requirements. Base for design validation is customer feed backs only.
Design Changes
Procedure described methods to identify, review and approve by design In-charge before their
implementation
Appropriate records are maintained and controlled, by M.R.
TITLE: PURCHASING
Purchasing is the responsibility of the purchase supervisor and includes the following activities for
product which stated by customer and if it is require to new manufacturing item then only approved
selected vender given the purchase order and all due care are taken for product conformity.
Purchasing process
It is ensured that purchased product conforms to specified purchase requirements by following:
Evaluation of suppliers
Suppliers are evaluated to assess their capability to meet requirements and selected on their merits &
availability.
The selected suppliers are included in the list of approved suppliers, which includes suppliers
supplying services like consultancy / training, maintenance, calibration, external laboratory
inspection agency, supporting parts for a manufacturing product, transport, currier which gives
details like items supplied type and extent of control exercised. Quality performance of approved
suppliers is monitored periodically and record is maintained.

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Sahibabad Plant
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The re-evaluation frequency depends upon the score of evaluation & the guidelines are as per the
format (F/PUR/ 04)
Note: This activity is applied to the suppliers of critical items only.
Purchasing information
Purchase orders / contracts contain accurate data about product description, type, class, grade,
wherever applicable. We also give reference of applicable issues of specifications / Process
requirement / Specification / inspection instruction / instruction for approval of product including
equipment, requirements for qualification of the personnel and quality management system
requirements.
Purchase orders are reviewed and approved before release.
Verification of purchased Product
We carry out verification of the purchased product at our end after receipt of product as per Quality
plans / Specifications.
Verification at the Suppliers place is seldom done but receiving inspection is ensuring that the
product is as per quality Plans / ITP
Generally our customer do not verify the / products at suppliers place. However if any Customer
specifies this requirement, it is discussed at contract review stage and mutually acceptable solution is
found and recorded in purchase order.
This verification arrangement is clearly mentioned on the purchase orders including method of
product release
Cross-reference:
IMSP/PUR/01
E/PUR/01

Quality Procedure for Purchase


Process-approach flow chart for Purchase

TITLE : PRODUCTION AND SERVICE PROVISION

CONTROL OF PRODUCTION AND SERVICE PROVISION


Director is primarily responsibility and I/C production is secondary responsible they have gathered
product information and also ensure for implement the standard criteria through necessary work
instruction for product manufacturing,
Servicing, operation of equipments.
They are also monitor and measurement done at planned interval
And check product/service conformities
They have implemented all the criteria of products before and post delivery release.

TITLE : VALIDATION OF PROCESS FOR PRODUCT AND SERVICE PROVSION


In our product manufacturing we have no special process which quality criteria apparently not
determined during product realization and need to validation of the process. Therefore this clause is
not applicable to our IMS requirement and it is address as Exclusion
TITLE : IDENTIFCATION AND TRACEABILITY

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Sahibabad Plant
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The Primary responsibility for the quality system element is with Purchase department and
subsequently responsibility of this element is with production & store incharge. The methodology
for identifying the product by suitable name and means at receiving, in-process and final stage is
established.
The status of the product like accepted, rejected, under inspection, in-process or under Rework etc. is
clearly marked on the products with the help of tags / stickers / boards/marking pen.
Total traceability is maintained for analysis of non- conformity through label/marking, suitable tags
identify products stored / boards, which co- relates to the supplier who had supplied it. Hence the
lot/batch no. date of mfg. raw material identification, size drawing etc can be traced to receiving
inspection report. Lot/Batch/Heat number is recorded as appropriately at receiving stage, which is
recorded on incoming inspection register, In-process production & inspection, assembly stage, final inspection report before dispatch refer to this parts/Lot number, batch No Serial No are shown in
finished product. Inspection and test report as well as mfg name plate parts manufacturing master
records are traceable to customer order/work order /shipment detail.
Ref: IMSP/Str/02: Product Identification& Tracebility& Product Recall.
CUSTOMER PROPERTY (clause no: 7.5.4)
M.R is primarily responsible for this element. He shall maintain the record of customer property
receipt and return after use, in case during process any non conformity is found than it is informed to
customer before it is taking in use. The relevant record is established and maintain as per the quality
procedure.
TITLE: PRESERVATION OF PRODUCT
Store department (STR) is primarily responsible for this function.
Suitable methods of handling the product during internal processing and delivery to destination
without causing damage or deterioration is used. Material in the organization is handled manually.
Designated storage areas with identification of products are used to store earmarked area/cupboard,
rakes are provided to store die/patterns, raw material / Components / finished goods and packing
materials to prevent damage or deterioration.
Appropriate Method of receipt and issues from such areas are implemented.
Packing materials including corrugated boxes are standard in nature and kept in stock. They are
assessed periodically for the quantity available in stores & Quality thereof. In case of shortage, it is
procured as aer requirement.
The condition of finished components including packing material, in stock at all Stages are
periodically checked. To detect damage / deterioration due to storage, store follows first in first out
(FIFO) system. Care has taken to ensure that packing is appropriate and will not cause damage to the
product during transit. Preservation of the product prior to final delivery is ensured.
Cross-Reference:
TITLE : CONTROL OF MONITERING AND MEASURING DEVICES
I/C prod is primarily responsible for this function. The criteria for selection of measuring and
monitoring devices considers requirement of capability of these devices to give accurate and precise
measurement so that uncertainty regarding measurement is eliminated and it provides evidence of
conformity of product and process to determined requirements.

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Sahibabad Plant
STANDARD OPERATING PROCEDURE
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A list of measuring and monitoring devices which affect the product / process quality is made and
taken up for calibration. Measuring and monitoring devices are identified by label containing devices
number / calibration dates and due dates.
The device is brought under calibration procedure & is calibration as per frequency decided. They are
adjusted or re adjusted as necessary. They are identified to indicate valid state of calibration &
verification of these devices is maintained. Calibration certificates are verified for the validity of the
master and traceability to National / International Standards.
Where no such standards exist, basis used for calibration or verification is recorded.
Proper actions (e.g. identification / recalling / re-inspection etc) are taken on product and the device,
when any device is found out of calibration.
Adequate care is taken during handling, storage, preservation & safe guarding of measuring and
monitoring device & all concern are suitably educated for this purpose.
TITLE : MEASURMENT, ANALYSIS AND IMPROVEMENT
All In-Charge are responsible for these activities.
Measurement and monitoring of data related to product conformity, process capability, Quality
management System and effectiveness are done as follows :
1.
Collection of data pertaining to product performance.
2.
Measurement reports of products.
3.
System NCR in audits.
4.
Customer Satisfaction Survey
5.
Customer complaints monitoring.
6.
Processes complaints monitoring.
7.
Details of non conforming products.
Based on these details, analysis is made using various methods. wherever applicable.
Suitable improvements, corrective actions and preventive actions are taken after the analysis as
defined in the system.
TITLE : CUSTOMER SATISFACTION
Primary responsibility for this activity is with CEO MKT department.
Customer satisfaction details like repeat orders, reduction in complaints,
Improvement in performance product, market penetration, customer feedback
For meeting their requirements are sought from the customer.
Once in a Year Also conduct satisfaction survey and know the level of satisfaction, suggestion
received from customer for improvement shall also review and documented. Suitable actions are
decided based on this monitoring of customer satisfaction to achieve improvement in it.
Suitable disposition and corrective actions are taken on customer complaint by effective analysis to
prevent their recurrences and the same is recorded.
TITLE : INTERNAL AUDITS
MR is primarily responsible for this activity. Internal Audits are conducted to verify whether the
quality objectives and related results comply with the planned arrangements and to determine
effectiveness of the quality management system align with requirements of the standard.

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Sahibabad Plant
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Internal Audits are scheduled once in six months to cover all areas of operations. Trained Internal
Auditors who are trained for conducting Audit is carry out the internal audit.
An audit plan is prepared to give details about audit schedule. Audit schedule takes in to account
status and importance of the processes and areas being audited.
Trained auditors independent of activities in the auditing area are chosen. The audit schedule gives
relevant clauses of the standard, which are applicable to the department
The auditor uses checklist to record the audit activity along with objective evidences. By reviewing
the check list MR ensure comprehensiveness of audit covering all requirements of ISO 9001 2008
standards. Non- conformities found during the audit are reported on non- conformity report forms
and brought to the notice of the audited department. Auditee gives the details of proposed disposal
and corrective action with target date of completion. MR reviews target date of completion for timely
actions. Proposed corrective actions are verified for their effectiveness in the next audit. Follow up
audit are conducted, as necessary, to ensure effective closure of NCR A summary of Audit Reports
forms part of the Minutes of Management Review.
Ref. Docs: - IMSP/IMS/04 Procedure for Internal Quality Audit
TITLE : MONITERING OF PROCESS:
HODs of respective department are responsible for this function, they have monitor and measure the
process by applying suitable method this is include daily operation and evaluation for small-step
toward continual improvement measurements of process performance cover for process capability,
reaction/Cycle time, process through put, outcome yield, effectiveness and efficiency of people,
Waste reduction/quality loss appropriate records are established and maintain for evidence and for
review purpose.
TITLE : MONITERING AND MEASUREMENT OF PRODUCT
Respective departments such as Store, Production and QC are responsible for monitoring and
measurement of the products is done at various stages as follows.
[A] Receiving stage: Measurement and testing of all incoming materials is done as per Quality Plan/ITP. Records of
measurement and maintained. In-coming products are not used until they have been inspected &
conformance to specified requirements has been verified.
An urgently required material may seldom be released prior to verification, but it is positively
identified & recorded to permit recall in the event of non-conformance to Specified requirements
[B] In process stage
Monitoring of in-process parameters as well as product measurements are carried out by In-charge
(QC) and Incharge (production) Those respective specifications are met as per ITP/ Quality Plan.
The records of in- process measurement and monitoring are maintained. In case of Non-conforming
product is resulted during the process, It is recorded and corrected by repair / rework and reinspected or re-graded other wise repairs/rework not possible than it scarped or alternative
application. Repaired & reworked product is re-inspected in accordance with Quality plan /
Specification
[C] Final stage

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The records of incoming stage and in process stage are taken into consideration While Doing final
testing or measurements of the product. In-Charge (QC) does the final testing or measurement as per
quality plan. Product delivery does not proceed until the planned Arrangement has been satisfactorily
completed. Acceptance are made only when approved by QC incharge or by customer.
Final measurements and test records are properly maintained and their retention period and mode of
disposal is mentioned on the respective file All the measurements, testing, monitoring records
maintained specify the Products (Parts) manufacturing date/batch/lot/Sr.no wise
TITLE : CONTROL OF NON-CONFORMING PRODUCT.
In-Charge of production & QC is responsible for this function.
Product non conformity is identified at every stage starting from in-coming material through final
finished product. Any non-conformity in product whether due to internal failure or complaint by the
customer is identified and controlled to prevent its unintended use or delivery. Responsibility and
authorities for dealing with non conforming products are clearly defined in IMSM section 2.6 & 2.7
The cause of non-conformity is investigated by systematic analysis and one of the following disposal
method is used :
1.
Rework to meet specified requirement
2.
Sale in discount
3.
Rejected and Disposed as scrape
Rework material is identified and re-verified before further processing.
When non conforming product is detected after delivery or use has started, appropriate action is
taken to avoid potential effects on the product quality.
Ref Docs: -SOP/S-3-007

Procedure for control of Non- Conforming Products

TITLE: EMERGENCY PREPAREDNESS ANS RESPONSE


ULTRA INTERNATIONAL LTD has established and maintained procedures to respond to accidents
and emergency situation for preventing and mitigating the impacts that may be associated with
them. DEEP INDUSTRIES shall review and revise when necessary. Its emergency preparation and
response procedure in particular after the occurrence of accident or emergency situations. The
organization shall also periodically test such procedures where practicable.
TITLE: ANALYSIS OF DATA
CEO & all In-charges are primarily responsible for this activity.
MR review monthly the data collected like customer satisfaction details, measurement or monitoring
reports of product and process characteristics, organizational performance report, supplier
performance reports, etc. and analyze this data for establishing, controlling and verifying process
capability, product characteristics, and improvement areas. The review also ensures suitability of the
Quality management System and the need for continual improvement in it. At present for analyzing
the customer complaints and internal rejections or product characteristics, cause and effect diagram /
trend graphs are used as applicable the corrective actions and preventive actions taken are monitored
to ensure their effectiveness
TITLE : CONTINUAL IMPROVEMENT
Suitable improvements, corrective actions and preventive actions are decided and implemented based
on the analysis of data. The quality policy, quality objectives, internal audit findings, product /

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Company Name

Sahibabad Plant
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INTEGRATED MANAGEMENT SYSTEM MANUAL


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process non-conformities from the basis for continual improvement. The actions taken are monitored
for effectiveness as mentioned in respective format or procedure these can lead to changes in quality
management system and other related documents to improve the system continually.
TITLE : CORRECTIVE ACTION
The primary responsibility of the corrective action on products & processes lies with inspection &
QC.
Non-MR handles Conformities in the systems as per documented work procedure that ensures: [A]
Reviewing non conformities, characteristics and trends of processes and products including
customer complains
[B]
Determining causes
[C]
Evaluating the need for action to prevent recurrence of non-conformities
[D]
Determining and implementing action needed
[E]
Records of corrective actions
[F]
Corrective action review for effectiveness
Cross Reference: Ref. Docs: IMSP/IMS/05

Procedure for Corrective and Preventive Actions

TITLE: PREVENTIVE ACTION


The primary responsibility of the Preventive Action lies with the MR/ all IC.
Documented procedure defines details for taking effective preventive action.
Preventive Actions are taken on potential non conformities after considering any one or more of the
following sources:
1.
Records of Management Review
2.
Records of Preventive Maintenance
3.
Records of contract review
4.
Records of supplier performances
5.
Records of System Non-conformities
6.
Records of process or product Non-Conformities
7.
Training records
8.
Records of Customer Complaints
9.
Characteristics and trends of processes and products including opportunity for preventive
action. Pertinent cause are identified and actions on potential non-conformities are decided
After evaluating the need for it. Suitable Preventive Actions are taken through pertinent
documents and are recorded. The Results are reviewed and monitored to prevent occurrence
of potential non-conformity.
Ref. Docs: - IMSP/IMS/05

Procedure for Corrective and Preventive Actions

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Company Name

Sahibabad Plant
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