devdatt industries title: master list of...

DEVDATT INDUSTRIES

TITLE: MASTER LIST OF QUALITY MANUAL DOC. NO : QF/01 CL. NO. : -- PG. NO. : 01 of 02

Sr. No.

CONTENTS

ID NO. ISO 9001 – 2008 CLAUSE NO.

NO. OF PG

REV. NO.

01 RECORD OF REVISION STATUS

QF/06 4.2 01 00

02 IDENTIFICATION SHEET QM/01 - 01

00

03 INTRODUCTION, SCOPE & APPLICABILITY OF CLAUSES

QM/02 - 01 00

04 LIST OF DEFINITIONS & ABBERVATIONS QM/03

- 02 00

05 DISTRIBUTION LIST OF QMS QM/04 - 01 00

06 QUALITY MANAGEMENT SYSTEM QM/05 4 01 00

07 GENERAL REQUIRMENTS QM/06 4.1 04 00

08 DOCUMENTATION REQUIREMENTS QM/07 4.2 02 00

09 MANAGMENT RESPONSIBILITY QM/08 5 01 00

10 QUALITY POLICY QM/09 5.3 01 00

11 PLANNING QM/10 5.4 02 00

12 RESPONSIBILITY AUTHORITY & COMMUNICACTION

QM/11 5.5 11 00

13 MANEGMENT REVIEW QM/12 5.6 02 00

14 RESOURCE MANAGEMENT QM/13 6 02 00

15 PRODUCT REALISATION QM/14 7 01 00

16 CUSTOMER RELATED PROCESS QM/15 7.2 01 00

17 DESIGN & DEVELOPMENT QM/16 7.3 01 00

18 PURCHASING

QM/17 7.4 02 00

19 PRODUCTION & SERVICE PROVISION QM/18 7.5 02 00

20 CONTROL OF MONITORING & MEASURING DEVICES

QM/19 7.6 01 00

21 MEASUREMENT ANALYSIS & IMPROVEMENT QM/20 8 01 00

22 MONITORING & MEASUREMENT QM/21 8.2 03 00

REV NO : 00 REL DT : 01/04/2010

PREPARATION & APPROVAL CERTIFICATE

MR prepares all the sections of this manual for Implementation.

MR Date: 01/04/2010

PARTNER approves all the sections in this manual for Implementation.

PARTNER Date: 01/04/2010

DEVDATT INDUSTRIES

TITLE: MASTER LIST OF QUALITY MANUAL DOC. NO : QF/01 CL. NO. : -- PG. NO. : 02 of 02

Sr. No.

CONTENTS ID NO. ISO 9001 – 2008 CLAUSE NO.

NO. OF PG

REV. NO.

23 CONTROL OF NON CONFORMING RPODUCT

QM/22 8.3 01 00

24 ANALYSIS OF DATA QM/23 8.4 01 00

25 IMPROVEMENT QM/24 8.5 01 00

26 MASTER LIST OF OPERATING PROCEDURES QF/02 4.2.3 01 00

27 MASTER LIST OF WORK INSTRUCTIONS QF/03 4.2.3 01 00

28 MASTER LIST OF FORMATS QF/04 4.2.3 02 00

REV NO : 00 REL DT : 01/04/2010



MR Date: 01/04/2010

PARTNER approves all the sections in this manual for Implementation.


DEVDATT INDUSTRIES

TITLE : RECORD OF REVISION STATUS

DOC. NO. : QF/06 CL. NO. : 4.2 PG. NO. : 01 of 01

Amendments are not permitted without authorization of MR.

SR. NO.

DOCUMENT NO.

NO. OF PAGES

REVISION NO

RELEASE DATE

DETAILS OF CHANGES Sign (MR)

REV NO:00 REL DATE:01/04/2010

DEVDATT INDUSTRIES

TITLE: IDENTIFICATION SHEET DOC. NO : QM/01 CL. NO. : -- PG. NO. : 01 of 01

APPLICABLE STANDARD

ISO 9001:2008

QMS ISSUE NO.

01

COPY NO.

01

RECEIVER’S NAME

Mr. PRASHANT JAWALKAR

DESIGNATION

PARTNER / MR

DATE OF ISSUE

01.04.2010

This copy of Quality Manual is handed over to you. Please acknowledge the

receipt. In case you leave the organization, please return this copy to MR. If you find any errors,

kindly bring it to the notice of MR.

The documented Quality Management System is the sole property of DEVDATT INDUSTRIES.

Nobody shall reproduce it fully / partly without the written permission of PARTNER.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: INTRODUCTION, SCOPE & APPLICABILITY OF CLAUSES DOC. NO : QM/02 CL. NO. : -- PG. NO. : 01 of 01

INTRODUCTION

DEVDATT INDUSTRIES is a small – scale industry situated at MIDC, Bhosari, Pune. DEVDATT INDUSTRIES started its manufacturing activities in 2010. Presently company is manufacturer of pressed, machined & fabricated components.

This manual describes the Quality Management System (QMS) as adopted & implemented by DEVDATT INDUSTRIES to demonstrate that company meets the Quality Policy & Objectives. The company has referred ISO 9001:2008 without design responsibility. It has been confirmed that the exclusion claimed from QMS would not affect the organization’s ability or responsibility to provide product that meets customer and applicable regulatory requirements. These documents together with the Operating Procedures, Work Instructions & Blank Formats – makes the companies’s QMS & are applicable to all departments.

THE POSTAL ADD. & PHONE NO. OF DEVDATT INDUSTRIES IS AS BELOW – POSTAL ADD: J – 484, MIDC, BHOSARI, PUNE – 411 026 PHONE NO.: +919850973129 As on date following are the customers of DEVDATT INDUSTRIES –

1) FORCE MOTORS LTD – AKURDI 2) POLYBOND INDIA PVT LTD – MARKAL 3) TATA INTERNATIONAL DLT PVT LTD – CHAKAN

SCOPE FOR CERTIFICATION OF ISO 9001:2008

“Manufacture of Pressed, Machined & Fabricated Components”

EXCLUSION OF CLAUSES Clause 7.3 - Design & Development Justification: - Since we manufacture machined metal components as per sample, drawings & specification given by the customers, the design & development activity is not applicable to our company. Therefore this clause has been excluded from our Quality Management System documentation.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: LIST OF DEFINITIONS & ABBRIVIATIONS DOC. NO : QM/03 CL. NO. : -- PG. NO. : 01 of 02

Following Definitions are referred in day to day working for QMS

Sr. No

ISO 9001:2008 Terminology

DEVDATT INDUSTRIES

Terminology

Definitions

01 Organization

Company

Company refers to the unit to which this International Standard applies

02 Supplier

Supplier (S) Suppliers are those outside agencies from whom consumables, catalogue products etc. supplies to DEVDATT

INDUSTRIES as per national or international standards.

03 Customer

Customer

Customers are those agencies who place their orders on DEVDATT INDUSTRIES as per their requirements.

04 Product

Product Product refers to the parts, which are manufactured as per customer requirements & are dispatched to customers.

05 Documents

Documents Document is that guiding information which is used for performing the activities. (For e.g. ISO 9001:2008 Standard, Quality Manual, Operating Procedures, Work Instructions, Blank Formats etc.)

06 Records

Records Record is that information which provides objective evidence of conformity to the requirements.

07 Resource Resource Resource includes application of man, material, method machine, money to meet requirements

08 Process Operation Activities performed at various stages of manufacturing to meet the product specifications.

09 Purchasing Information

Purchase order /Amendment order

It is the order placed by the customer on DEVDATT

INDUSTRIES or by on its suppliers.

10 Internal Audit Internal Audit (IA) It is an on site verification activity based upon a sample used with reference to QMS as per ISO 9001:2008 of all the functions of DEVDATT INDUSTRIES

11 Calibration Calibration A set of operation which compare values taken from a piece of Inspection Measuring & Test Equipment or a gauge to a known standard under specified condition.

12 Quality Manual Quality Manual It is the DEVDATT INDUSTRIES document which describes the scope & applicability of the elements of ISO 9001:2008. It also interlinks operating procedures / Work Instruction / Blank Formats as per requirements.

13 Quality Plan Process Plan These are the specifications as per customer required to facilitate operators or In charge to work to meet the product specifications.

14 Non Conformity

Non Conformity It is a process which does not meet to QMS requirements

15 Non Conformance

Non Conformance It is that product which does not meet customers specifications

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: LIST OF DEFINITIONS & ABBRIVIATIONS DOC. NO : QM/03 CL. NO. : -- PG. NO. : 02 of 02

AO AMENDMENT ORDER

B/D BREAK DOWN

BS BRITISH STANDARD

CAPA CORRECTIVE ACTION PREVENTIVE ACTION

C CLAUSE

CIR CONTINUAL IMPROVEMENT REGISTER

CP CONTROL PLAN

CSI CUSTOMER SATISFACTION INDEX

DI DEVDATT INDUSTRIES

DPIR DAILY PRODUCTION & INSPECTION REPORT

GIOR GOODS INWARD OUTWARD REGISTER

INSP INSPECTION

IA INTERNAL AUDIT

IS INDIAN STANDARD

ISO INTERNATIONL ORGANISATION FOR STANDARDISATION

M/C MACHINE

MAT MATERIAL

MF MANUFACTURING

MKT MARKETING

MME MONITORING & MEASUREMENT EQIPMENTS

MM MILLIMETER

MAINT MAINTENANCE

MR MANAGEMENT REPRESENTATIVE

MRM MANAGEMENT REVIEW MEETING

NA NOT APPLICABLE

NC NON CONFORMANCE

OFI OPPURTINITY FOR IMPROVEMENT

PFD PROCESS FLOW DIAGRAM

PM PREVENTIVE MAINTENANCE

PO PURCHASE ORDER

PP PROCESS PLAN

QF QUALITY FORMATS

QM QUALITY MANUAL

QMS QUALITY MANAGEMENT SYSTEM

R/W REWORK

REF REFERENCE

REJ REJECTION

REV REVISION

RIR RECIEPT INSPECTION REPORT

S SUPPLIER

S/C SUB CONTRACTOR

WI WORK INSTRUCTION

WIP WORK IN – PROGRESS

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: DISTRIBUTION LIST OF QMS DOC. NO : QM/04 CL. NO. : -- PG. NO. : 01 of 01

Following are the holders of the copies of this QMS (Quality Manual, Operating Procedures, Work Instructions, Forms / Formats)

COPY NO.

COPY HOLDER TYPE OF COPY ACKNOWLEDGEMENT OF FIRST ISSUE

1 MR / PARTNER Master Copy

2 Shop Floor (Work Instructions) -----

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : QUALITY MANAGEMENT SYSTEM DOC. NO : QM/05 CL. NO. : 4 PG. NO. : 01 of 01

QUALITY MANAGEMENT SYSTEM

IT INCLUDES:

QUALITY MANUAL (QM)

OPERATING PROCEDURE (OP)

WORK INSTRUCTION (WI)

BLANK FORMATS (QF)

ALL QUALITY PLANNING DOCUMENTS (PFD, PP, CUTOMER SPECIFICATION,

APPLICABLE IS STANDARDS & ISO 9001: 2008 STANDARD)

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : GENERAL REQUIREMENTS DOC. NO : QM/06 CL. NO. : 4.1 PG. NO. : 01 of 04

a) Documentation Requirements:

The organization has established, documented, implemented maintains Quality Management System & continually improves its effectiveness in accordance with the requirements of this QMS as per ISO 9001:2008. Each QMS document is uniquely identified as following: XX/XX 1 2 Letters at 1 indicate type of document as under: QM: Quality Manual OP: Operating Procedure WI: Work Instruction QF: Quality Format Number at 2 indicates serial No of that document. For Example – QM/01: Indicates first document of Quality Manual. OP/01: Indicates first document of Operating Procedure. WI/02: Indicates second Work Instruction. QF/01: Indicates first format. Every Page of above QMS documents except Forms & Formats contain following information:

1. REV NO: It is given serially. It is applied to each page as 00 as on 01/04/2010. 2. REL.DATE: This shows “Date of Release” either first issue or revision. It is also the date of Implementation

I. The Top Management has established a customer-oriented organization.

a. By defining systems & process that can be clearly understood, managed and improved in effectiveness as well as efficiency (QM/06 Page 03 & 04); and

b. By ensuring effective and efficient operation & control of process and the measures and data used to determine satisfactory performance of the organization (MRM minutes (QF/07), Internal Audit (QF/34) results and project of continual improvement through CIR. (QF/16)

II. The organization a) Identifies the process needed for the QMS & their application through out the company. Refer page 03

& 04 (QM/06) b) Determines the sequences & interaction of these processes. Refer page 03 & 04 (QM/06) c) Determines criteria & method needed to ensure that both the operations & control of these processes

are effective through Quality planning documents i.e. PFD, PP, QM, OP, WI, Formats & inspection records.

d) Ensures the availability of resources & information necessary to support the operation & monitoring these processes. Skill matrix, M/C utilization, ML of MME & gauges, ML of machines.

e) Monitor, measure & analyze these processes (Daily Production Report, PDIR) & IA results. f) Implements the action necessary to achieve planned results & continual improvement of these

processes, These processes are managed by the organization in accordance with the requirements of this QMS as per ISO 9001:2008. Where organization chooses to outsource any process that affects product conformity with requirements, Organization will ensure the control over set processes. Controls of such outsourced processes will be identified within QMS.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


1. All related operations required for the manufacturing of a product have been established in our PFD (QF/23). 2. The sequence & interrelationship between all the persons are also shown by organization chart

(QM/11 pg.11 of 11) & by internal communication (QM/11 pg. 10 of 11)

3. No process identified as outsourced in our organization.

4. Following documents have been identified which are extremely needed for the QMS & their application throughout the organization. Quality Policy, Quality Objectives, Quality Manual, Operating Procedure, Work Instructions, Blank Formats, Quality Planning documents like Customer / International / National standards, Customer drawings, our Process Flow Diagrams, Process Plan.

Customers Quality Plan, Records required by ISO 9001:2008. {ref ML of Formats (QF/04) &} procedure

for Control of Records (OP/02).

b) Management Responsibility: Management commitment, Customer focus (CSI – QF/21), Quality Policy, Quality Objectives, QMS Planning, Responsibility, Authority & Communication, Management Representative, Management Review Meeting. c) Resource Management: Provision of resources – List of Machine (QF/13), List of employees (QF/15), Skill matrix (QF/12), Human resources, (Annual training plan, training effectiveness). d) Production Realisation:

Planning of products realization (Production Planning, Customers PO/AO, Our quotation, purchasing process, purchasing information, verification of purchase product, product realization & traceability. Preservation of product (RM storage & packed final product), Control of monitoring & measuring devices (Details of Measuring Equipment & Gauges (QF/37), Calibration certificate.

e) Measurement, analysis Improvement:

RIR (QF/09), DPIR (QF/25), PDIR (QF/35), MRM minutes, progress made through Quality Objectives, Customer satisfaction Index (QF/21), Annual IA Plan (QF/32), IA CA Report (QF34), CC Register (QF/22), NC register (QF/41), Supplier / Sub Contractor assessment form (QF/26) selection & their performance report.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


REV NO : 00 REL DT : 01/04/2010

Receipt of enquiry / specification of the product from the customer (original or changed requirements)

Customer related process

Control of documents

Study of the requirements of Customer

Control of Records

Quotation to Customer

Depending upon the our capability of manufacturing

Reply to Customer Saying that we cannot supply the product

Depending upon the our capability of manufacturing

Control of Document

Receipt of Customer PO

Review of Customer specification, quotation & Customer PO

If No ambiguity, confirmation of PO to customer

If any mismatch, inform to Customer

Product Realization – Including measuring & monitoring activity 1. Preparation of PFD, PP. 2. Preparation of Work Instruction 3. Approval of all newly prepared documents. 4. Study of related standards.

1. Evaluation & selection of Supplier / S/c 2. To check with customer, whether customer

approved supplier available and to be used or not.

3. Provision of resources (Man, Mat., M/c, Method & Money)- / Ensuring

Release of PO to approved Supplier / S/c

Mentioning verification activity to be conducted where & by whom

Reevaluation of Supp. and re -finalization of List of Supplier / S/c

Receipt of purchase material & receipt inspection

Control & monitoring devices

Incoming inspection, Daily Production & Inspection Report, PDIR

DEVDATT INDUSTRIES


Continued…

Rework Re-inspection

Repair Re-inspection

Segregation Re-inspection

Reject Scrap

REV NO : 00 REL DT : 01/04/2010

Production & Service Provision

Customer satisfaction feedback from customer

Daily Production & Inspection Report, If accepted next operation. If not accepted, hold & decision

If not accepted, Rework – Re inspection Rework Segregation – Re inspection Reject – Scarp

Final Inspection

If acceptable at customer end

Receipt of Money from Customer

If not acceptable at customer end

Packing / Preservation

If accepted, storage/preservation & issue of material for manufacturing

If non conformity observed, decision & sending back to Supplier / S/c

Receipt of purchase material & receipt inspection

Dispatch to Customer as per schedule along with PDIR

DEVDATT INDUSTRIES

TITLE: DOCUMENTATION REQUIREMENT DOC. NO : QM/07 CL. NO. : 4.2 PG. NO. : 01 of 02

4.2.1 GENERAL: DEVDATT INDUSTRIES has established Quality Management System, which includes

a) Documented Quality Policy (QM/09) & Quality Objectives (QM/10) b) Quality Manual (QM/01) to (QM/24) in addition to record of revision sheet (QF/06), Master

List (ML) of Operating Procedure, (QF/02) Master List of Work Instructions (QF/03), & Master List of Formats (QF/04).

c) Documented Procedures required by these QMS as per ISO 9001:2008 are given in Master List of Operating Procedure (QF/02)

d) Documents like PFD, PP, Customer drawing & Specification needed by the company to ensure the effective planning, operations & control of its process and

e) Records required by this QMS as per ISO 9001:2008 – Master List of Quality Formats.

4.2.2 QUALITY MANNUAL The company has established & maintained a Quality Manual which includes

a) Scope of the QMS, including details of & justification for any exclusion like Design & Development 7.3.

b) Documented Procedure as per Master List of Operating Procedure (QF/02) established for the QMS.

c) A description of the interaction between the process of the QMS (for e.g. Organization chart (QM/11) pg. 11 of 11 & Process Flow Diagram (QM/06) pg. 03 & 04 of 04.

4.2.3 CONTROL OF DOCUMENTS Following guidelines are referred to prepare documented procedure for Control of Documents related to requirements of ISO 9001: 2008 Document requirements by the QMS are controlled. All requirements are controlled as required by QMS. A documented procedure (OP/01) has been established to define the controls needed for approving, reviewing, updating, changing, identifying current version maintaining, and all documents as legible distributing to related functions and to prevent unintended use of obsolete documents. For preparation & approval of various level QMS documents which are available in (WI/01) – WI for Document control.

A) Document originated externally:

i) MR maintains the documents related to Quality Management System (ISO 9001: 2008), and any other Indian / International Standards procured related to QMS.

ii) MR maintains Standards related to products, Customer Specification, other documents

related to manufacturing.

iii) Responsible concerned authorities maintain lists of their documents indicating current

revision status.

iv) Any further document, which is received, will follow above control.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : DOCUMENTATION REQUIREMENT DOC. NO : QM/07 CL. NO. : 4.2 PG. NO. : 02 of 02

B) Document Originated Internally:

i. MR prepares & ensures that the Quality Manual, Operating Procedures, Work Instructions and Blank

Forms (Master Copy) are reviewed and approved by PARTNER; authorized MR releases Controlled

Copies.

ii. Following Master List with current revision status is retained function wise.

1. Master List of Operating Procedure (QF/02) – Responsible to update – MR

2. Master List of Work Instruction (QF/03) – Responsible to update – MR

3. Master List of Blank Forms & Formats (QF/04) – Responsible to update – MR

4. Contents of Quality Manual (QF/01) – Responsible to update – MR

iii. MR ensures that following documents are prepared and Reviewed / Approved by MR prior to issue of

Controlled Copy. All Quality Planning Documents (PFD, PP etc).

iv. MR is responsible to withdraw invalid or obsolete controlled copies from the point of use

v. On receipt of new standard, specification and changes the existing document & records are reviewed and changes are implemented on all related internal documents. The same is applicable for internally originated changes. The change effect on product is confirmed in PDIR and intimated to customers. vi. The review of material at receipt, in process and finish goods is taken and request for deviation is

approved from customer for dispatching as per old modification.

vii. Customers inform about changes of Standards with current modification / date / year to DEVDATT

INDUSTRIES. Any changes is received it is promptly acted upon.

viii. Workers of DEVDATT INDUSTRIES may also suggest change to internally document.

ix. The changes in the document are identified by revision number which is updated to next number &

release date from which document is effective & released.

x. MR updates the necessary Master List in consultation with concerned authorities.

4.2.4 CONTROL OF RECORDS Records are established & maintained to provide evidence of conformity to requirements & for the effective operation of the QMS. Records are maintained generally in hard copy form which are legible, readily identifiable & retrievable. All the records are identified, stored properly, protected & disposed off as per retention period, by MR. Ref.: 1) Operating Procedure for control of records (OP/02) – Includes List of Mandatory Records. 2) Master List of Quality Formats (QF/04).

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : MANAGEMENT RESPONSIBILITY DOC. NO : QM/08 CL. NO. : 5 PG. NO. : 01 of 01

5.1 MANAGEMENT COMMITMENT PARTNER provides evidence of its commitment to the development & implementation of the quality management system and continually improving its effectiveness by

a) Communicating to the organization the importance of meeting customer as well as statutory & regulatory requirements (by means of meeting etc.)

b) Establishing the quality policy (QM/09). c) Ensuring that quality objectives are established, Ref: Quality Objectives (QM/10). d) Conducting Management Review Meeting (QF/07)

e) Ensuing the availability of resources. Ref. Provision of resources (QM/13) 5.2 CUSTOMER FOCUS

PARTNER ensures that customer requirements are determined and are met with the aim of enhancing the customer satisfaction. Ref. : Development enquiry register (QF/17) Customer P.O. Customer schedule.

Customer Satisfaction Index (CSI) – (QF/21) Verbal Order Register (QF/08)

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: QUALITY POLICY DOC. NO : QM/09 CL. NO. : 5.3 PG. NO. : 01 of 01

PARTNER ensure that the

1) Quality Policy is appropriate to the purpose of the company

2) The Quality policy is defined and displayed in the plant and offices.

3) Quality Policy includes a commitment to comply with requirements & continually improve the

effectiveness of the quality management system

4) Quality Policy provides the framework for establishing & reviewing Quality Objectives.

5) Quality Policy is communicated & understood within the company & 6) The implementation and maintenance of Quality Policy & Objectives is ensured by periodical

auditing & reviews.

QUALITY POLICY

“We the members of DEVDATT INDUSTRIES are

dedicated to enhance our customer satisfaction, by supply of

Quality Products, on time delivery through continual improvement

in our Quality Management System.”

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: PLANNING DOC. NO : QM/10 CL. NO. : 5.4 PG. NO. : 01 of 02

5.4.1 QUALITY OBJECTIVES: PARTNER ensures that Quality Objectives are relevant to Quality Policy of DEVDATT INDUSTRIES. These Quality Objectives are established because these are needed to meet the product requirement also. These Quality Objectives are established at related functions & levels within the company. Quality objectives shall be reviewed as & when required based on business requirements & growth of the organization. The Quality Objectives are measurable & consistent with Quality policy.

Our Quality Objectives are as below:-

a) On time delivery to all customers as per order.

b) Inhouse Rejection – To keep below 0.1% per month.

c) Customer End Rejection – To keep 0 per month.

d) Customer Satisfaction Index min 80 % per annum.

e) Provide training to employees – Minimum 06 hours per year.

5.4.2: QUALITY MANAGEMENT SYSTEM PLANNING PARTNER ensures that

a) The planning of QMS is carried out in order to meet the requirements given in 4.1, as well as Quality Objectives, Analysis of Quality Objectives (QF/18).

b) The integrity of the QMS is maintained when changes to the QMS are planned & implemented.

Ref: Procedure of Internal Audit (OP/03). The Quality Manual covers the requirements of ISO 9001:2008. It contains Quality Policy &

Objectives of management and also describes a summary of Quality Planning done in line with clauses of ISO

9001:2008, which also provides guidelines to formulate operating procedures for each function. QM gives

references at appropriate places of respective operating procedures.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: PLANNING DOC. NO : QM/10 CL. NO. : 5.4 PG. NO. : 02 of 02

Operating Procedures define the methodology of work carried out in functional areas.

Operating procedure gives reference at appropriate places of respective forms/formats.

Work Instructions define the method of doing specific task. Operating procedure give reference

at appropriate places of respective Work Instruction.

Form & formats are used to generate Quality Record & Quality Planning documents. Filled

forms & formats contain the information as an evidence to prove that the quality management system adopted

by company is implemented and is effective. Above forms & formats show preparation and approval of

responsibilities as necessary. Minimum retention period for Quality Records are established, in line with ISO

9001:2008 and contractual requirements. Records are preserved for such defined period.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: RESPONSIBILITY, AUTHORITY AND COMMUNICATION DOC. NO : QM/11 CL. NO. : 5.5 PG. NO. : 01 of 11

5.5.1 RESPONSIBILITY & AUTHORITY:

PARTNER ensures that Responsibility and Authorities are defined and communicated within the Company. i) Responsibilities and authorities have been identified considering following.

1. Inter relation of personnel who manage, perform and verify activities that affect quality. 2. Requirement of understanding customer needs meeting by way of MRM. 3. To convey the decision to next levels of personnel through various plans and make them understand the same and to verify the implementations of decisions. 4. To stop production in case of product or process non-conformities through

Designated channels. 5. To maintain necessary quality records for any problems relating to the product process

and quality system. ii) In addition to the above general responsibilities of employees, the specific responsibility of MR is also defined. iii) The authorities are defined considering executive requirement so as to accomplish the defined responsibilities in order satisfy the quality system requirements. The responsibilities in order to satisfy the quality system requirements. The responsibilities and authority of employee represents the needs of the customer in internal functions in addressing ISO 9001:2008 requirements. iv) Enclosed ‘Organization Structure’ shows the administrative hierarchy of officers within organization.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


Designation: PARTNER (MARKETING / PURCHASE / PRODUCTION / QA / MR) RESPONSIBILITY:

1. Study of enquiries received from customer. 2. Receive, study the customers PO/AO and release PO / AO. 3. Manufacturing planning as per customer schedule & dispatches. 4. Handling customer complaints. 5. Compile CSI & follow up for improvement. 6. Participate in Management Review Meeting. 7. Review & ensure the approach to customer requirements. 8. Review of CONTINUAL IMPROVEMENT PROGRESS. 9. Review of Internal Auditing Repot. 10. Review of ISO implementation. 11. Plan resources for training. 12. Investigate, suggest & ensure effective implementation of corrective & preventative action related

to N.C. of product, process & QMS. 13. PARTNER is responsible for determining & maintaining statutory & regulatory, Govt. health &

safety requirement as applicable. 14. Evaluation & selection of supplier. 15. Schedule for P.M. of machines. 16. Procurement m/c & equipment. 17. Control of quality records & documents. 18. Ensure necessary work environment for product manufacturing.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


AUTHORITY:

1. To delegate the responsibility and authority.

2. To resource deployments as over all in-charge of company.

3. To identify the needs for resources & training.

4. To take necessary action for improvement through Continual Improvement.

5. To approve all company level forms-formats/WI/Procedures/OP/PP/ all inspection reports

generated at various stages of manufacturing.

6. To change in process.

7. To review enquiry & purchase order from existing new customers.

8. To sign purchase document.

9. To evaluate /select / delete the suppliers / s/c.

10. Hold supply of NC products of supplier / s/c.

11. To take disposal action of NC products like rework or repair. 12. To handle customer complaints.

13. To plan for procurements spares-parts or repairs.

14. To procure required Instruments & equipment.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


5.5.2 MANAGEMENT REPRESENTATIVE Designation: Management Representative (MR) Reporting To: --- RESPONSIBILITY:

1) Arrange Training for workers. 2) Study the enquiries received from customer. 3) Handling Customer complaint. 4) Compile CSI & follow up for improvement. 5) Approach to customer requirement. 6) Review IA Report 7) Review ISO 9001:2008 implementation. 8) Plan resource & training. 9) Ensure necessary work environment product manufacturing. 10) Conduct MRM. 11) Implement QMS. 12) Control on document. 13) Control of quality records & documents.

MANAGEMENT REPRESENTATIVE:

The PARTNER Mr. Prashant Jawalkar has decided he himself will be the Management

Representative (MR) WHO IRRESPECTIVE OF OTHER REPONSIBILITIES HAS DEFINED AUTHORITY

FOR:

a) Ensuring that Quality System is established implemented and maintained in

accordance with applicable ISO 9001:2008 standard without design

responsibility & service provision.

b) Reporting on the performance of the Quality System to the management for

review & as improvement of the Quality System.

c) Ensuring the promotion of awareness of customer requirements through out

the company

The Management Representative (MR) also has an responsible for liaison with external parties on matters

relating to company’s Quality System.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


AUTHORITY :

1) To take decision on faculty for training.

2) To assign the work to workers.

3) To identify the needs for resources & training

4) To prepare establish and implement company Quality manual.

5) To make recommendations for training.

6) To conduct & close Internal Audit.

7) To make recommendations for improvements in ISO 9001: 2008 Implementations.

8) To participate and present Quality Objectives in MRM.

9) To plan and execute continual improvement with reference to CIR.

10) To delegate responsibilities and authority to concerned person.

11) To prepare company level forms/format/WI/OP/PP.

12) To prepare & approve QMS Document & Report.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


Designation: QA I/c Reporting To: PARTNER RESPONSIBILITY:

1) Work allocation to ensure QA activities are performed as per OP 2) Take necessary action to avoid N.C.

3) Control on N.C. product & investigate cause of N.C.

4) Control of quality records & documents

5) To plan, repair & calibrate instruments.

6) Continuous improvement through Quality Objectives.

7) Prepare preventive maintenance chart.

8) Ensure daily preventive maintenance activity.

AUTHORITY:

1) To prepare control plan.

2) To identify need of resources & training.

3) To approve all inspection reports generated at various stages of manufacturing.

4) To take disposal action of NC products.

5) To suggest needs of Instruments.

6) To take necessary action on occurrence of NC.

7) To plan, repair & calibrate instruments.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


Designation : PRODUCTION I/c Reporting To : PARTNER RESPONSIBILITY:

1) Manufacturing, planning as per customer schedule & process plan. 2) Ensure necessary work environment for product manufacturing. 3) Plan for handling, packaging, and preservation of product during manufacturing. 4) Manpower development to achieve schedule target. 5) Take necessary action to avoid N.C. 6) To co – ordinate with other sections & maintain flow of material. 7) Plan with Production I/c to fulfill on-time delivery to customer. 8) Continuous improvement through Quality Objectives. 9) Co ordination with operators. 10) Allocating daily work to operators.

AUTHORITY:

1) To stop production in case product process NC is reported. 2) To identify the needs for resources & training. 3) To take necessary action on occurrence of NC. 4) To handle customer complaints. 5) To take action on break down maintenance. 6) To suggest needs of Instruments & equipment. 7) To release raw material from designated storage area.

8) To do preventive maintenance of mc as per plan

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


Designation: OPERATORS

Reporting To: PRODUCTION I/c RESPONSIBILITY:

1) Machine cleaning on every working day.

2) Production according to Process Plan.

3) Reduction in In-Process rejection / at final stage while production.

4) To keep material at proper place. AUTHORITY:-

1) Put suggestions regarding improvements.

2) Contact to Prod I/c regarding Non-Conformity observes.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


Sr. No. Clause No PARTNER MR MK PROD QA PUR

1. 4.1 S P S S S S

2. 4.2 S P S S S S

3. 5.1 P S S S S S

4. 5.2 P S S S S S

5. 5.3 P S S S S S

6. 5.4 P S S S S S

7. 5.5 P S S S S S

8. 5.6 P S S S S S

9. 6.1 P S S S S S

10. 6.2 P S S S S S

11. 6.3 P S S S S S

12. 6.4 S S S P S S

13. 7.1 S P S S S S

14. 7.2 S S P P S S

15. 7.4 S S S S S P

16. 7.5 S S S P P S

17. 7.6 S S S P P S

18. 8.1 P S S S S S

19. 8.2 S P S S S S

20. 8.3 S S S S P S

21. 8.4 S P S S S S

22. 8.5 P P P P P P

P : Primary Responsibility

S : Secondary Responsibility

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: RESPONSIBILITY, AUTHORITY AND COMMUNICATION DOC. NO : QM/11 CL. NO. : 5.5.3 PG. NO. : 10 of 11

5.5.3 INTERNAL COMMUNICATION PARTNER ensures that appropriate communication process is established within the company by means of Operating Procedure, Work Instructions, & Quality Records. PARTNER also ensures that communication takes place regarding the effectiveness of QMS by means of MRM (QF/07) Responsibilities & authorities of the personal in the Organization are communicated through MR. QM copy

& for down level, they communicates responsibility & authorities by verbally or showing QM copy Internal Communication can be done by following ways, - Directly comminuting in work areas with down level. - Notice boards displayed in work areas.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


ORGANIZATION CHART

REV NO : 00 REL DT : 01/04/2010

PARTNER Marketing / Purchase

Production / QA I/c

Operators

PARTNER Production / QA / MR

DEVDATT INDUSTRIES

TITLE : MANAGEMENT REVIEW DOC. NO : QM/12 CL. NO. : 5.6 PG. NO. : 01 of 02

5.6.1 GENERAL PARTNER reviews the company QMS at planned interval, every six months after Internal Audit, to ensure continuing suitability, adequacy and effectiveness, however only 1st MRM is conducted after 1st Internal Audit. This review includes assessing opportunities for improvements and the need for changes to the QMS, including the Quality policy (QM/09) & Quality Objectives. Records of MRM are maintained

a) Regular management review is performed to assess the effectiveness of Quality System in achieving Quality Policy, Quality Objectives.

b) Extraordinary MRM may be needed due to events like customer complaints / visits / audits /

increase in N. C. trends. c) PARTNER is chairperson for all MRM. d) All management members are participant of the regular management review. For

extraordinary review MR decides participants & agenda.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : MANAGEMENT REVIEW DOC. NO : QM/12 CL. NO. : 5.6 PG. NO. : 02 of 02

5.6.2 REVIEW INPUT: The agenda for every regular MRM is as below

a) Results of audits b) Customer feedback

c) Process performance & product conformity

d) Status of preventive & corrective actions

e) Follow up actions from Previous MRM

f) Changes that could affect the QMS

g) Recommendation for improvement

h) Review of Quality Policy, Quality Objectives & QMS for adequacy, suitability & effectiveness.

i) Supplier performance.

5.6.3 REVIEW OUTPUT: The output form management review includes any decision and action related to : a) Improvement of the effectiveness of the QMS & its processes, by means of IA results.

b) Improvement of product related to customer requirements, by means of CSI & improvement in Quality Objectives.

c) Resource needs, by means of organization chart.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : RESOURCE MANAGEMENT DOC. NO : QM/13 CL. NO. : 6 PG. NO. : 01 of 02

6.1 PROVISION OF RESOURCES The company determines & provides the resources needed

a) To implement & maintain the QMS & continually improve its effectiveness by virtue of IA & working for improvement in Quality Objectives.

b) To enhance customer satisfaction by meeting customer requirements by the use of customer satisfaction index & Quality Objectives. Company makes the provision of resources (man, machine, material, method & money) as per customer requirement by virtue of Minutes of MRM (QF/07). 6.2 HUMAN RESOURCES 6.2.1 GENERAL It is ensured by the company that personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience. Refer: List of Employees (QF/15), Annual training plan & record (QF/10), skill matrix (QF/12). 6.2.2 COMETENCE AWARENESS & TRAINING The company

a) Determines the necessary competence for personnel performing work affecting product quality Refer Training Record (QF/10).

b) Provides training or take other actions to satisfy these needs. Refer Annual Training Plan

(QF/10).

c) Evaluates the effectiveness of action taken. Refer MRM Minutes (QF/07).

d) Ensures that its personnel are aware of the relevance & importance of their activities & how they contribute to achievement of the quality objectives.

e) Maintains appropriate records of education, training, skills & experience in Skill Matrix (QF/12)

& reviewed yearly.

f) Competency level is decided for all designations, mentioned in Competency Matrix (QF/11).

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : RESOURCE MANAGEMENT DOC. NO : QM/13 CL. NO. : 6 PG. NO. : 02 of 02

6.3 INFRASTRUCTURE The company determines, provides & maintains the infrastructure needed to achieve conformity to product requirements. Infrastructures includes (as applicable)

a) Building, work space & associated utilities.

b) Process equipment (List of Machine QF/13), Details of Instrument & Gauges QF/37. c) Supporting devices (telephone, e – mail).

6.4 WORK ENVIORNMENT

The company determines & manages work environment needed to achieve conformity to product requirements by virtue of

a) Proper lighting arrangement. b) Adequate resources.

c) Proper housekeeping.

d) Proper drinking water availability.

e) Fire Fighting Equipment.

f) First Aid Box

g) Toilet.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : PRODUCT REALISATION DOC. NO : QM/14 CL. NO. : 7 PG. NO. : 01 of 01

7.1 PLANNING OF PRODUCT REALISATION The company plans & develops the processes needed for product realization as per customer’s specification of product. Planning of product realization is consistent to the requirements of other processes of the quality management system. In planning product realization, the company determines the following

a) Quality objectives (QF /18) & requirements for the product as per customer specification. b) The need to establish processes documents & provides resources specific to the product (for

e.g. all Quality planning documents like – PFD (QF/23) and Process Plan (QF/42), all documented procedures.

c) Required verification, validation, monitoring, inspection & test activities specific to the product &

the criteria for product acceptance (for e.g. all quality records, calibration certificates, DPIR).

d) Records needed to provide evidence that the realization processes & resulting product meet requirements. For e.g. all quality records of product inspection & continual improvement.

The output of this planning is available in the form of quality records as per company’s method of operations.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : CUSTOMER RELATED PROCESS DOC. NO : QM/15 CL. NO. : 7.2 PG. NO. : 01 of 01

7.2.1 : DETERMINATION OF REQUIREMENTS RELATED TO PRODUCT The company determines:

a) Requirements specified by the customer, including the requirements for delivery & post delivery activities, in the form of customer P.O, customer schedule, customer specifications, customer A.O. for regular products. New product enquiry is entered in Development Enquiry Register (QF/17). Requirement of any additional extra resources & capacity for that product is mentioned.

b) Requirements not stated by the customer but necessary for specified or intended use,

where known, by virtue of purpose changes in the schedules for the delivery of the products, dispatch destination as told by the customer verbally.

c) Statutory & regulatory requirements related to product. 7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT The company reviews the requirements related to the product with respect to availability of resources and customer specifications. The review is conducted prior to the companies commitment to supply a product to the customer. This done by sending quotation & receiving of customer P.O/A.O/ schedules. The company ensures that

a) Product requirements are defined b) Contract or order requirement differing from those previously expressed are resolved

(verbal order register QF/08) &

c) The company has the ability to meet the defined requirements. This done by virtue of reviewing & accepting customer P.O. The records of the results of the review are maintained for each customer. Where the customer does not provide documented statement of requirements, the customer requirements are conformed by the company before acceptance in writing through letter. Where product requirements are changed the company ensures that relevant documents like PO / Customer specifications are amended and that the relevant personnel are made aware of the changed products by means of verbal meeting / circulars.

7.2.3: CUSTOMER COMMUNICATION

The company determines & implement effective arrangements for communicating with customer in relation to –

a) Product information by means of verbal discussion about dispatches & through PDIR (QF/35). b) Enquiries, contracts or order handling including amendments by means of customer formats

of order acceptance duly signed by company.

c) Customer feedback, including customer complaints by means of telephonic information or letter or customer prescribed format of corrective and preventive action.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : DESIGN AND DEVELOPMENT DOC. NO : QM/16 CL. NO. : 7.3 PG. NO. : 01 of 01

7.3 DESIGN AND DEVELOPMENT Since we manufacture as per the drawings, specifications given by the customers, the

design & development activity is not applicable to our company.

Therefore this clause has been excluded from our Quality Management System documentation

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : PURCHASING DOC. NO : QM/17 CL. NO. : 7.4 PG. NO. : 01 of 02

7.4.1 PURCHASING PROCESS:

Following guidelines are referred to ensure that purchased product meets specified requirements –

List of company approved suppliers / sub contractors (QF/24) are prepared, as on date (01/04/2010)

suppliers / sub contractors & who are supplying material has been directly approved on the basis of their

past performance. List also includes customer approved supplier / sub contractor (if applicable). It is

referred for purchasing of relevant materials.

In future, if purchasing is required from other than list of supplier / sub contractor or from supplier / sub

contractor who are not approved by customer, company evaluates & selects the supplier / sub contractor

based on their ability to supplied product in accordance with the company’s requirements by supplier / sub

contractor assessment form (QF/26).

This list of supplier / sub contractor (QF/24) is updated based on communication from the customer &

assessment by company.

Re evaluation control over approved supplier / sub contractor is exercised by Quality & Delivery rating i.e. if

suppliers / sub contractors material is rejected twice in a year or if they deliver late twice in a year (Receipt

Inspection Report QF/09); CAPA will be taken & records are maintained.

7.4.2 PURCHASING INFORMATION: Generally open purchase order is released to supplier annually & monthly supply schedule is given verbally.

Purchase Order is issued only for purchasing above Rs.2000. Purchasing Order (QF/31) contains following

data as appropriate

i.) Description of material.

ii) Grade or other precise identification.

iii) Reference of specification.

iv) Rate & other commercial information.

v) Delivery schedule with instruction for 100% on time delivery.

vi) Inspection instruction, compliance to various Government safety & environment applicable rule /

regulation if any.

vii) Requirement of approval of product, Process, Equipment, Procedures, and other requirements.

viii) Packing, transport instructions.

ix) QMS requirement – if any purchase orders are reviewed for adequacy of above information before

releasing by PARTNER.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : PURCHASING DOC. NO : QM/17 CL. NO. : 7.4 PG. NO. : 02 of 02

7.4.3 VERIFICATION OF PURCHASED PRODUCTS:

i) This is done by company, at company's premises for ensuring that purchased product meet

specified purchase requirements.

ii) As applicable verification is done at supplier / sub contractor end also. In this case relevant

purchase order indicates this requirement.

iii) If contractually required, verification by customer at supplier / sub contractor premises is

arranged. Relevant purchase order indicates this requirement.

However verification by customer does not become basis of acceptance by company. The company

ensures that components / products are conforming to requirements at receipts and dispatch stage.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : PRODUCTION & SERVICE PROVISION DOC. NO : QM/18 CL. NO. : 7.5 PG. NO. : 01 of 02

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION:

The company plans and carries out production under controlled condition. The controlled condition includes (as applicable)

1. The availability if information that describes the characteristics of the product (Quality planning documents like customer drawing, PFD (QF/23), Process Plan (QF/42)

2. The availability of work instruction, as necessary (as stated in Master List of Work instruction – (QF/03)

3. The use of suitable equipment (as stated in list of machines– QF/13). 4. The availability & use of monitoring & measuring devices (as stated in Details of Instrument –

(QF/37). 5. The implementation of monitoring & measurement by means of production report like DPIR (QF/25),

PDIR (QF/35), & 6. The implementation of release, delivery & post delivery activities by means of remarks on inspection

reports, delivery challan (QF/36). i. Post delivery activity is defied as our scope of supply does not include servicing &

our responsibility ceases on acceptance of material by the customer except like rejection, if any.

7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION & SERVICE PROVISION: The organization validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any process where deficiencies become apparent only after the product in use or service has been delivered. Validation demonstrates the ability of these processes to achieve planned results.

The organization has established arrangements for these processes including as applicable A) Defined criteria for review and approval of the process, B) Approval of equipment and qualification of personnel (Special process qualification report

QF/43) C) Use of specific methods and products. D) Requirements for records. E) Revalidation is done if customer complaint received. Presently a) Co2 Welding (Inhouse) identified for validation of process.

7.5.3 IDENTIFICATION & TRACEABILITY: The company identifies the product by means of tags (QF/05) through out product realization as appropriate. The company identifies the product status by means of the inspection reports. Where traceability is a requirement, products of all customers are recorded the unique identification by means of tags.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : PRODUCTION & SERVICE PROVISION DOC. NO : QM/18 CL. NO. : 7.5 PG. NO. : 02 of 02

7.5.4 CUSTOMER PROPERTY:

The company takes care of customer property while it is under the company’s control or being

used by the company. The company will use tags / reports / bins / demarked areas etc. to identify, protect, verify & safeguard customer property provide for use or incorporation into the product. If any customer property lost, damaged or otherwise found to be unsuitable for use, it is reported to customer immediately by means of letter, stock statements & its records are maintained. Present customer property are identified in List of Customer Supplied Items (QF/39).

7.5.5 PRESERVATION OF PRODUCT:

The company preserves the conformity of product during internal processing & delivery to the

Intended destination of customer by means of proper packing / surface treatment as applicable.

This preservation includes identification, packaging, storage & protection preservation also apply to the constituent parts of a product (as applicable) during manufacturing.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : CONTROL OF MONITORING & MEASURING EQUIPMENTS DOC. NO : QM/19 CL. NO. : 7.6 PG. NO. : 01 of 01

Following guidelines are referred to prepare documented procedure to control, calibrate and maintain,

inspection measuring and test equipment’s, used to demonstrate conformance of product to specified

requirements. As a policy, DEVDATT INDUSTRIES does not allow use of employee owned MME.

i. MME which directly affect Product Quality and used for control of process parameters are identified for calibration.

ii. These are given unique identification numbers to track calibration status. Details of Instruments & Gauges (QF/37) is made and it is updated depending upon addition or deletion of MME.

iii. Calibration Plan of Measuring Instruments & Gauges (QF/37) is made and followed to maintain frequency of calibration. iv. Calibration is done by approved calibration agency having calibrations standard traceable to recognized national standard. The calibration data is validated against intended use and approves. v. Inspection, measuring and test equipment are kept in respective boxes / original packing wherever possible and safeguarded from adjustment which would invalidate calibration setting. vi. If MME is found out of calibration, results of previous inspection are reviewed and appropriate action is taken on MME and suspect products. vii. If agreed contractually, calibration data is made available to customer. viii. Calibration of MME is conducted by a accredited commercial / independent laboratory or a customer

recognized government agency.

ix. Calibration records are maintained in Details of Instrument & Gauge (QF/37) for these MME. This gives

details such as least count, frequency etc. Which are uniquely identified with location and show evidence of

periodical calibration as per plan and conformance to specification and acceptable uncertainties including

the suitability for use. This also shows as-received status of instrument when received new or duly

calibrated. Revision following engineering changes (as appropriate) is taken care off. Customer is notified if

suspect product is supplied as a result of calibration MME are observed. Statement of conformance to

specification after calibration is noted in record.

x. If MME calibration labs are not certified by nationally recognized accreditation body. Then waiver for

using customer approved is taken in written. In such cases MME is identified with stickers and kept

separate as not traceable to National Standard. MME is re – calibrated with Laboratory traceable to

National Standard.

xi. Presently company is not using any computer software for monitoring and measurement of product or

process.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : MEASUREMENT ANALYSIS AND IMPROVEMENT DOC. NO : QM/20 CL. NO. : 8 PG. NO. : 01 OF 01

8.1 GENERAL

The company plans & implement the monitoring, measurement, analysis & improvement processes needed

a) To demonstrate conformity of the product by means of inspection report like RIR (QF/09), DPIR (QF/25) & PDIR (QF/35).

b) To ensure conformity of the Quality management system by means of MRM (QF/07) & Internal audit results.

c) To continually improve the effectiveness of the quality management system by means of

process in quality objectives.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : MONITORING AND MEASUREMENT DOC. NO : QM/21 CL. NO. : 8.2 PG. NO. : 01 of 03

8.2.1 CUSTOMER SATISFACTION: A) For new future customer:

i) Various magazines/reports are referred to collect information about potential customer. ii) Customer satisfaction & dissatisfaction information, about competitor’s similar product is also collected. iii) Each potential customer is contacted & explained about company's procedure to ensure customer satisfaction on continuous basis.

B) For existing customer:

i) Every year, Customer Satisfaction Survey report (QF/20) is sent to each Customer & CSI is calculated as per (QF/21).

ii) The target for achieving minimum CSI is defined in the format where this is not achieved, then the action plan is prepared to arrive at customer’s dissatisfaction areas & actions required for improvement to ensure to achieve minimum CSI.

iii) The company level Quality Objectives is studied & co-relation between customer dissatisfaction area is established.

iv) CSI trend is calculated & presented in MRM (QF/07) along with action plan.

8.2.2 INTERNAL AUDIT:

SCOPE: Applicable to all the departments in the organization excluding accounts CRITERIA: Ensure that all clauses, processes & function have been audited. (Including MR function) Following guidelines are referred to prepare documented procedure for planning and implementing Internal

Audits to verify compliance to Quality System.

A) Audit Frequency: Six monthly Internal Audits for all functions are carried out as per IA Plan for all clauses

by trained Internal Auditor; however only 1st internal audit is conducted before certification audit after 3

months of implementation of QMS. MR may decide to hold unplanned audits based on certain events

like, customer visit / customer complaints & rejection % age increased, target not meeting, follow up of

NC closure etc such audits shall be planned based on importance and status of related function.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


B) References of checklists are available for auditing, which are appended considering specific event or

finding of previous audits. IA checklist (QF/33) to be used by each auditor at each audit.

C) Audit findings are recorded in internal audit & corrective action report (QF/34) and timely corrective

actions are taken by concerned person as planned.

D) Follow-up audit is done for verification of corrective action and its effectiveness. Records of Internal

Audits are maintained in internal audit & corrective action report (QF/34).

I) Audit findings are submitted in MRM for review.

J) Addition of Internal Auditors. During every MRM while discussing the status of Internal Audit, the need of

additional auditors is discussed. PARTNER is requested to nominate the officers to MR to organize Internal

Audit programs.

K) Annual IA Plan (QF/32) is prepared; accordingly Internal audit schedule (QF/30) for audit is released in

advance.

L) Frequency of audit is subjected to change due to any event. MR decides the change in frequency, which

is reviewed in MRM. This frequency is increased in case of increasing trends in Product / Process NC’s,

internal /external audit NC’s, customer complaints etc.

M) The internal auditors selected as he should be trained by certified lead auditor & as well as on the basis

of educational qualification / work experience. Ref : Operating Procedure for Internal Audit (OP/03)

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES


8.2.3 MONITORING & MEASUREMENT OF PROCESSES:

The company applies methods for monitoring and, where applicable measurement the QMS

processes. This includes Internal Audit. These methods demonstrate the ability of processes to achieve

planned results when planned results are not achieved, corrective & preventive action are taken, as

appropriate to ensure conformity of the product.

8.2.4 MONITORING & MEASUREMENT OF PRODUCT: The company monitors & measures the characteristics of the product to verify that product

requirements are met by means of inspection reports. The monitoring & measurements is carried out at

appropriate stages with respect to customer drawing of the product realization. Process in accordance with

the quality planning document of the company (e.g. PFD, PP). Evidence of conformity with acceptance

criteria is maintained in each inspection report. Inspection report indicates the person (s) authorizing release

of product (e.g. DPIR – QF/25, PDIR – QF/35).

Product release does not happen & until the planned arrangement have been satisfactorily completed,

unless otherwise approved by Production I/c or QA I/c or PARTNER & where applicable, by the customer.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : CONTROL OF NONCONFORMING PRODUCTS DOC. NO : QM/22 CL. NO. : 8.3 PG. NO. : 01 OF 01

The company ensures that the product which does not conform to product requirements is identified by means of tag / demarked area / N.C. Register / Inspection reports and these non conforming products are controlled to prevents its unintended use or delivery the controls & related responsibilities & authorities for dealing with nonconforming products are defined in the documented procedure (OP/04) The company deals with nonconforming products by one or more of the following ways.

a) By taking action to eliminate the detected nonconformity (N.C. Register QF/41) b) By authorizing its use, release or acceptance under concession by PARTNER, and were

applicable the customer.

c) By taking action to preclude its original intended use or application. Records of the nature of the non conformities and any subsequent action taken, including

concessions obtained are maintained (e.g. N.C. Register – QF/41). When N.C. product is corrected, It is re – inspected to demonstrate the conformity to the requirements (e.g. N.C. Register– QF/41) when N.C. product is detected after delivery or use has started, company gets information from customer then customer complaint register is updated & necessary CA & PA are taken.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: ANALYSIS OF DATA

DOC. NO : QM/23 CL. NO. : 8.4 PG. NO. : 01 of 01

a) Company has defined the continual improvement project (Quality Objectives) as per document

(QF/18) These are related to Quality operational performance, and current quality levels for key product

features. These Quality Objectives indicate past & current trends, including targets to be achieved.

b) Monthly data is collected by analyzing appropriate records available in company to compute the

Quality Objectives.

c) After studying earlier performance of the company & general industrial practices self – developed

benchmarks are decided for each Quality Objective. These are authorized by PARTNER.

d) The current status is discussed in every MRM. For Quality Objectives (QM/10), which are not as per

benchmarks an action, plan is prepared and followed (QF/18). Such action plan contains corrective &

preventive actions, which are taken in QMS through changes in OP documentation.

e) Priorities are given to improve Quality Objectives related to customer – related problems. For this the

dissatisfaction reported by customer are correlated with company Quality Objectives.

f) Decisions about additions/deletions about above indicators are taken during MRM. This also includes

up-gradations for any or all Quality Objectives targets.

g) Records of above reviews are kept in MRM File (QF/07). h) The analysis of data provides information relating to

1) Customer satisfaction (CSI) – QF/21

2) Conformity to product requirement (PDIR) – QF/35

3) Characteristics trends of process & product including opportunities for

preventive action (Quality Objectives QF/18)

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE : IMPROVEMENT DOC. NO : QM/24 CL. NO. : 8.5 PG. NO. : 01 of 01

8.5.1 : CONTINUAL IMPROVEMENT The company continually improves the effectiveness of the QMS through the use of Quality policy (QM/09), Analysis of Quality objectives (QF/18), Audit results / IA report (QF/34), Analysis of data (QM/23) Corrective and preventive action and management review / MRM (QF/07) 8.5.2 : CORRECTIVE ACTION The company takes action to eliminate the cause of nonconformity in order to prevent recurrence. The corrective action taken are appropriate to the effects of the non conformities encountered (e.g. N.C. Register (QF/41). An operating procedure (OP/05) has been established to define requirements for

a) Reviewing non conformities (including customer complaints) by means of N.C. Register

(QF/41) and Customer Complaint Register (QF/22).

b) Determining the causes of non-conformities by means of CA. c) Evaluating the need for action to ensure that non-conformities do not recur, by means of MRM.

d) Determining and implementing action needed by means of IA results.

e) Record of the results of action taken by means of MRM, CA.

f) Reviewing corrective action taken by means of MRM, CA.

8.5.3 : PREVENTIVE ACTION The company determines the action to eliminate the causes of potential non conformities in order to prevent their occurrence. Preventive action are taken which are appropriate to effects of the potential problems. An operating procedure (OP/06) has been established to define requirements for

a) Determining potential non conformities and their causes (CA and N.C. Register QF/41) b) Evaluating the need for action to prevent occurrence of non conformities (PA and MRM)

c) Determining & implementing action needed (MRM)

d) Records of results of action taken (Preventive Action)

e) Reviewing preventive action taken (MRM)

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: MASTER LIST OF FORMS & FORMATS DOC. NO : QF/04 CL. NO. : 4.2 PG. NO. : 01 of 02

Sr. No.

Forms & Formats

No.

Description Distribution Filing Location

Retention Period

Rev No.

Doc /

Rec.

1 QF/01 Master List of Quality Manual All concern Office 3 years 00 Doc

2 QF/02 Master list of Operating Procedure All concern Office 3 years 00 Doc

3 QF/03 Master list of Work Instructions All concern Office 3 years 00 Doc

4 QF/04 Master list of Forms & Formats All concern Office 3 years 00 Doc

5 QF/05 Tags Production Shop 3 years 00 Doc

6 QF/06 Record of Revision Status MR Office 3 years 00 Rec.

7 QF/07 Management Review Meeting PARTNER Office 3 years 00 Rec.

8 QF/08 Verbal Order Register Production Office 1 year 00 Rec.

9 QF/09 Receipt Inspection Report QA Office 3 months 00 Rec.

10 QF/10 Annual Training Plan & Record MR Office 3 years 00 Rec.

11 QF/11 Competency Matrix MR Office 3 years 00 Doc

12 QF/12 Skill Matrix All concern Office 1 year 00 Doc

13 QF/13 List of Machines

Production Office 3 years 00 Doc

14 QF/14 List of Internal Auditor

PARTNER Office 3 years 00 Doc

15 QF/15 List of Employees MR Office Till ser. 00 Doc

16 QF/16 Continual Improvement Register MR Office 3 years 00 Rec.

17 QF/17 Development Enquiry Register PARTNER Office 3 years 00 Rec.

18 QF/18 Analysis of Quality Objectives

MR Office 3 years 00 Rec.

19 QF/19 List of Standards QA Office 3 years 00 Doc

20 QF/20 Customer Satisfactory Survey Form Marketing Office 3 years 00 Rec.

21 QF/21 Customer Satisfactory Index Marketing Office 3 years 00 Rec.

22 QF/22 Customer Complaint Register QA Office 3 years 00 Rec.

23 QF/23 Process Flow Diagram Production Office Till prod. 00 Doc.

24 QF/24 List of approved Suppliers & S/c QA Office 3 years 00 Doc

25 QF/25 Daily Production & Inspection Report Production Shop 03 months

00 Rec.

26 QF/26 Supplier & Sub contractor Assessment Form

Materials Office 3 years 00 Rec.

REV NO : 00 REL DT : 01/04/2010

DEVDATT INDUSTRIES

TITLE: MASTER LIST OF FORMS & FORMATS DOC. NO : QF/04 CL. NO. : 4.2 PG. NO. : 02 of 02

Sr. No.

Forms & Formats

No.

Description Distribution Filing Location

Retention Period

Rev No.

Doc /

Rec.

27 QF/27 Goods Inward / Outward Register Materials Office 1 year 00 Rec.

28 QF/28 List of Customer Drawing Production Shop 3 years 00 Doc

29 QF/29 Cause & Effect Analysis All concern Office 1 year 00 Rec.

30 QF/30 Internal Audit Schedule QA Office 3 years 00 Rec.

31 QF/31 Purchase Order

PARTNER Office 1 year 00 Rec.

32 QF/32 Annual Internal Audit Plan MR Office 3 years 00 Doc

33 QF/33 Internal Audit Check List

MR Office 3 years 00 Doc

34 QF/34 Internal Audit Corrective Action Report

QA Office 3 years 00 Rec.

35 QF/35 Pre Dispatch Inspection Report QA Shop 03 months 00 Rec.

36 QF/36 Delivery Challan Materials Shop 03 months 00 Rec.

37 QF/37 Details of Instruments & Gauges QA Office 3 years 00 Rec.

38 QF/38 Break Down Maintenance Report Production Shop 1 year 00 Rec.

39 QF/39 List of Customer Supplied Item

QA Shop 3 years 00 Doc

40 QF/40 Preventive Maintenance Chart Production Shop 1 year 00 Rec.

41 QF/41 N.C. Register Production Shop 3 years 00 Rec.

42 QF/42 Process Plan

QA Office Till production

00 Doc.

43 QF/43 Special Process Qualification Report QA Shop 3 years 00 Rec.

44 QF/44 List of Dies Production Shop Till production

00 Doc.

REV NO : 00 REL DT : 01/04/2010



MR Date: 01/04/2010 PARTNER approves all the sections in this manual for Implementation.
