Sebros QMS Manual
Sebros QMS Manual
Sebros QMS Manual
CONTENTS
CLAUSE
REF.
TITLE
PAGE No.
1
2
3
4.0
4.1
4.2
CONTENTS
LIST OF COPY HOLDERS
REVISION STATUS OF QUALITY MANUAL
SCOPE AND EXCLUSION
COMPANY PROFILE
QUALITY MANAGEMENT SYSTEMS
GENERAL REQUIREMENTS
DOCUMENTATION REQUIREMENTS
01
02
03
04
05
06-09
5.0
5.1
5.2
5.3
5.4
5.5
5.6
MANAGEMENT RESPONSIBILITY
MANAGEMENT-COMMITMENT
CUSTOMER FOCUS
QUALITY POLICY
PLANNING
RESPONSIBILTY AUTHORITY &COMMUNICATION
MANAGEMENT REVIEW
10-13
6.0
6.1
6.2
6.3
6.4
RESOURCE MANAGEMENT
PROVISION OF RESOURCES
HUMAN RESOURCES
INFRASTRUCTURE
WORK ENVIRONMENT
14-16
7.0
7.1
7.2
7.3
7.4
7.5
PRODUCT REALISATION
PLANNING OF PRODUCT REALISATION
CUSTOMER RELATED PROCESSES
DESIGN & DEVELOPMENT
PURCHASE
PRODUCTION & SERVICE PROVISION
17-27
8.0
8.1
8.2
8.3
8.4
8.5
28-34
ANNEXURES
MANAGEMENT RESPONSIBILITIES & AUTHORITIES
PROCESS SEQUENCE & INTERACTION
QUALITY POLICY & OBJECTIVES
ORGANISATION CHART
ABBREVIATION
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ANNEXURE -1
ANNEXURE 2
ANNEXURE 3 & 4
ANNEXURE 5
ANNEXURE 6
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COPY Nos.
Master Copy
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01
02
HOD Development
03
Manager Production
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05
Certification Body
06
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A. Automotive customers:
Maruti Suzuki India Ltd.
Suzuki Power train India Ltd.
Inapex Ltd., Delhi.
Volvo Eicher Commercial Vehicle Ltd.
The manufacturing facilities include bending facilities including CNC bending machines,
Power presses, Hydraulic presses, welding machines, Induction hardening machines,
brazing machines, DG set, compressors etc.
The unit has an extended work bench which supports some manufacturing activities
(i.e. Bending, Flaring, and Welding and Brazing operations with development &
manufacturing).
The unit has an in-house tool room consisting of milling machines, lathes, surface
grinder, drilling machine etc.
The unit also has a standards room with instruments and gauges for carrying out layout
inspection of components and internal calibration of receiver gauges and fixtures.
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:
:
:
:
Quality manual
Procedure manual
Documents / work instructions
Records
QUALITY MANUAL:
PROCEDURES MANUAL:
The organization has prepared all the procedures including seven mandatory
procedures as per requirements of ISO/TS16949:2009 International Standard.
PART C)
Documents / work instruction defines all the step by step process for their activities for
all the departments/function as:
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ENGINEERING SPECIFICATIONS
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5.2
CUSTOMER FOCUS
5.3
QUALITY POLICY
CEO has laid down the quality policy and objectives keeping in view the scope of the
organization and showing commitment to comply with the requirements and continual
improvement in compliance with QMS. Quality Policy and Objectives, which are
communicated and well understood by all employees, shall be periodically reviewed for
their suitability.
Ref: - Annexure No. 3 & 4
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PLANNING
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6.3.0 INFRASTRUCTURE
CEO shall determine, provide and maintain the infrastructure needed to achieve
conformity to product requirements including buildings, workplace and associated
utilities process equipment as also the supporting services like telephones for
communication and computers etc.
6.3.1.1 PLANT, FACILITY AND EQUIPMENT PLANNING
Project management methodology is used to establish the necessary infrastructure for
new products, new production and development needs. Plant layouts are determined by
industrial engineering for optimization and cost to ensure value added use of floor
space. Methods are developed and implemented to evaluate and monitor the
effectiveness of existing operations,
e.g. competitive data from subcontractors, simulation models.
Ref: - Procedure for Plant facilities and equipment planning (PROD/SP-1/6.3.1/RN)
Ref: - Plant layout (PLO)
Ref: - Procedure for Plant maintenance (PROD/SP-2/6.3.0/RN)
Maintenance of Plant is being done as per the following1)
Plan of manufacturing areas divide separate for each section.
2)
Entire construction is with R.C.C. floor and all other areas are finished with white
washing.
3)
All areas are well lighted and covered with asbestos roof views for adequate
ventilated and equipped with proper exhaust system and required safety safe
guard are provided.
4)
Overhead tanks are cleaned regularly & finally washed with disinfectants before
the storage of raw water.
5)
Preventive maintenance for premise is a regular process & it will be done by
maintenance in-charge & recorded.
List of equipment and machine is prepared and maintenance of these is being done as
per the maintenance schedule.
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CONTINGENCY PLANS
CEO has prepared the contingency plan for business recovery to provide continual
service to the customer during events of emergency such as utility interruptions, labour
shortages, and key equipment failure and field returns.
CEO determines, provides and maintains the infrastructure necessary for the realization
of product while considering the needs and expectation of customers needed to achieve
conformity to product requirements. Infrastructure includes as applicable below as(a) Building, workspace and associated utilities (layout),
(b) Process equipment,
(c) Supporting services.
Ref: - Contingency Plan (CGYP)
6.4.0 WORK ENVIRONMENT
The organization determines the work environment needed to achieve conformity to
product requirements and manages it.
4.1.0 PERSONNEL SAFETY TO ACHIEVE PRODUCT QUALITY
SIPL is committed to provide the environmental, health and safety program, the health
and safety of employees and the surrounding communities.
GM determines and manages the work environment needed to achieve conformity to
product requirements. He ensures that the work environment has positive influence on
motivation, satisfaction and performance of people in order to enhance the performance
of the organization.
Top management developed a system for product safety and means to minimize
potential risks to employees for development process and manufacturing activities.
4.2.0 CLEANLINESS OF PREMISES
Top management defined a system to maintain the cleanliness and repair of the
premises as per the product and manufacturing process need.
There are the written instructions for cleaning all the departments everyday & written
instruction for maintain the 5S system in working areas.
Plant head ensures that:
1) Cleaning of road/drains, plant corridor, toilet, administrative building
2) Cleaning of water tank.
3) Fire fighting
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PRODUCT REALISATION
7.1
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7.3
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During the business planning process described in business plan, future development
for processes and assembly processes are considered. This becomes the basis for
establishing future products. The appropriation of funds to support future product
development starts with customer needs that are established by market analysis and
close customer relationships. These inputs drive the long-term roadmaps for technology,
packaging and products. This planning is performed during the annual budgeting
process. Reference Business Planning, Budgets and Forecasting in Financial Planning.
Once management approves the project for development of a new process, the
following requirements are determined in accordance with Management Representative.
a) Quality objectives and requirements for the product,
b) Establishment of the processes, documents, and resources specific to the product.
c) The required verification, validation, monitoring, inspection and test activities specific
to the process and the criteria for process acceptance, and
d) Records needed to provide evidence that the realization processes and the resulting
product meet requirements.
Ref: - Procedure for manufacturing process design & development
(DEV/SP-1/7.3.0/RN)
7.4
PURCHASING
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7.5
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WORK INSTRUCTIONS
SIPL prepared the Work instructions for all processes done in the organization. All Work
instructions are controlled as per the documented system.
Work instruction also comply the Control plan, Quality plan and product realization
process.
7.5.1.3
SIPL have a record for Job set-up verification at the time of change the job or material.
Job set up verification is being done in the in process inspection report.
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SIPL has established and implemented a system for tooling management as specified.
Tooling Management covers all the equipments. The above methodology addresses the
effectiveness for: operation efficiency, maintenance schedule, maintenance adjustment
consistent with equipment utilization, and tool change program for perishable tools.
Periodic Inspection and maintenance are carried out for all process equipment Utilities
Indirectly involved in the process are also serviced periodically. Both in-house
maintenance and annual maintenance contracts from manufacturers, all activities are
documented.
Ref: - Procedure for Tooling management (PROD/SP-4/7.5.1/RN)
7.5.1.6 PRODUCTION SCHEDULING
SIPL is scheduling the production as per the customer requirements so that product will
be delivered on time. SIPL informs to customer about the status of production.
7.5.1.7 FEEDBACK OF INFORMATION FROM SERVICE
SIPL has a system for feedback on service concerns like manufacturing, engineering &
development activities. A communication system is maintained for this.
7.5.1.8 SERVICE AGREEMENT WITH CUSTOMER
SIPL is manufacturing the tubular & fabricated parts for automotive industries. The
organization has no any service center. In future if any service process will be identified
then all the information about the service will be recorded like-evaluation of the
Organization service center performance, any special tools or measuring tools and
training of service personnel
7.5.2 VALIDATION
PROVISION
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PRODUCTION AND
SERVICE
SIPL validates all the processes related to the product as per the criteria for review and
approval of the processes, approval of equipment and qualification of personnel,
process method and revalidation. These activities are done and recorded.
7.5.3 IDENTIFICATION AND TRACEABILITY
SIPL ensures proper identification of the product by suitable means from receipt to
delivery stages. Where and to the extent that traceability is a specified requirement, the
company shall maintain it.
7.5.3.1 IDENTIFICATION AND TRACEABILITY (SUPPLEMENTAL)
The system defined in section 7.5.3 is capable of doing a trace forward and backward
within 24 hours. It covers product lots, processes and materials to satisfy customer
needs for risk abatement and containment.
The above system for identification and tractability address the requirements for all
Product and processes.
In charge QA is responsible for maintaining identification, Traceability and determining
the status of product at various stages.
Raw material, in process material, finished goods, goods for reworking and
rejected material is suitably identified at location.
Every inspection, measuring and test equipment is identified by a sticker and a
unique identity number.
Every machine/ equipment (mechanical and electrical) is also identified by a
unique number.
Ref: - Procedure for Identification and traceability control (PROD/SP-5/7.5.3/RN)
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(c)
(d)
All critical measurement / inspection after each operation are determined and
included in process work instructions.
A comprehensive Master list of all Monitoring and Measuring devices that can
affect quality is prepared. The frequency of calibration or verification initially has
been determined by experience, Practices in the industry and accuracy of
measurement sought and acceptance criteria. The devices are calibrated or
verified at specified intervals or prior to use against measurement standards
traceable to international or national measurements standards.
The list shows the code no. of devices, Type, Calibration frequency, location etc.
basis of calibrations or verifications shall be documented.
All monitoring and measuring devices are adjusted or readjusted as necessary.
(e)
All monitoring and measuring devices are identified by a sticker, which indicates
the calibration status whether done internally or externally.
(f)
All monitoring and measuring devices are tamper proofed and safeguarded to
avoid unauthorized adjustment and calibration or verification that would invalidate
the calibration or verification settings.
(g)
The handling, maintenance, storage and use of all monitoring and measuring
devices are carried out by experienced personnel ensuring that the accuracy and
fitness are maintained. Any shortcoming noticed is removed by periodic training to
such operators/ supervisors.
(h)
If the device is found to be out of calibration or verification at any stage, the validity
of previous monitoring & measurement results of such suspect product is checked
to the extent possible. Appropriate action is taken on the equipment and the
product affected.
(i) The calibration or verification, monitoring and measuring devices is carried out at
environmentally controlled conditions to the extent necessary and possible to
ensure valid measurement results giving due consideration to temperature and
humidity.
Ref: - Procedure for Measurement system analysis (QA/SP-3/7.6.1/RN)
7.6.3 LABORATORY REQUIREMENTS
7.6.3.1 INTERNAL LABORATORY
SIPL has no any internal laboratory.
7.6.3.1 EXTERNAL LABORATORY
SIPL used the External Laboratory for Calibration of instruments only. In-charge Quality
is ensured that external laboratory should be the ISO17025 or national equivalent.
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Records of the nature of nonconformities and any subsequent action taken are
maintained.
Ref: - Procedure for Control of nonconforming product (QA/SP-5/8.3.0/RN)
8.3.1 CONTROL OF NONCONFORMING PRODUCT SUPPLEMENTAL
SIPL processes do not allow unidentified or suspect material to remain in processing. It
is treated as non-conforming material. Nonconforming product is identified and
immediately placed in a status that prevents its re introduction in to the production flow.
8.3.2 CONTROL OF REWORKED PRODUCT
Rework to meet specified requirements is determined in the control plan. Allowable
rework is documented and remains with the production in-charge. Rework instructions
are accessible and utilized by the appropriate personnel in their designated work areas.
Visible rework on the exterior of the product is not permitted.
Where a process is developed for reworking product, the requirements that were
established for qualification of the initial process are performed to ensure compliance of
the rework method.
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8.5 IMPROVEMENT
8.5.1 CONTINUAL IMPROVEMENT
The Top management has developed a system to continually improve the effectiveness
of QMS by monitoring quality policy, objectives, audit results, corrective & preventive
actions and Management review.
8.5.1.1 CONTINUAL IMPROVEMENT OF THE ORGANIZATION
SIPL continually improves the effectiveness of the quality management system through
the use of the quality policy, quality objectives, audit results, analysis of data, corrective
and preventive actions and management review. The data that is collected from the
various processes is used by management to improve the effectiveness of the quality
management system. This is achieved in management review meetings held by top
management. The SIPL organization establishes the needed processes for continual
improvement. These processes include breakthrough projects and small-step ongoing
improvement activities. Changes for continual improvement are managed through
various processes.
8.5.1.2 MANUFACTURING PROCESS IMPROVEMENT
SIPL ensured that the requirements to continually focus upon control and reduction of
variation in product characteristics and manufacturing process parameters.
8.5.2 CORRECTIVE ACTION
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QA ENGINEERS :
MAINTENANCE INCHARGE:
a) Overall responsible for preventive, breakdown and predictive maintenance of
Production equipment & machines etc.
b) Predictive maintenance activities and guidance to maintenance technicians and
production staff in machine maintenance.
PURCHASE INCHARGE :
a) Overall responsible for activities related to purchasing and stores.
b) Evaluation and selection of suppliers and maintaining approved supplier list.
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PRODUCTION SUPERVISORS:
To execute production as per plan in their allotted areas / processes.
To monitor production and maintain production/rejection reports.
To provide on-the-job training to operators as per plan and instructions.
To ensure daily machine maintenance and housekeeping in shop floor areas.
13.
QC ENGINEERS / INSPECTORS :
a) To perform inspection & testing activities at allocated stages and to generate and
maintain reports accordingly.
b) To maintain identification and inspection status at the respective allocated areas.
c) To identify, record and evaluate nonconforming products at respective allocated
areas.
d) Collection and analysis of data of non conforming materials at all stages in order
to take corrective actions.
e) Application of statistical techniques as per documented procedures.
14.
a)
b)
c)
d)
e)
f)
g)
STORES INCHARGE :
Overall In-charge of Stores activities.
Performance monitoring of suppliers.
Control of receipt and issue of all materials from stores.
Proper handling and storage of materials to avoid deterioration, damage or loss
Periodic assessment of all the materials in stock.
Quality, Delivery performance and premium freight monitoring of all suppliers.
Overall responsible for receipt and control of customer supplied materials and
information to customer in case of discrepancy etc.
Note: Production & QA in charges shall be promptly informed (not later than eight
hours) of products or processes which do not conform to requirements.
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S.
No.
PROCESS NAME
1.
TOP MANAGEMENT
2.
3.
PRODUCTION
4.
MAINTENANCE &
MANAGEMENT OF
PRODUCTION TOOLING
5.
6.
7.
QUALITY ASSURANCE
MIS / DMR
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*
*
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QUALITY POLICY
CUSTOMER SATISFACTION BY SUPPLYING
PRODUCT MEETING FULL SPECIFICATION AND
TIMELY DELIVERY BY ADHERING TO QUALITY
SYSTEM AND CONTINUOUS IMPROVEMENT.
RAH
UL MALIK
(CEO)
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QUALITY OBJECTIVES
COMPLAINTS.
REDUCE CUSTOMER
REJECTION.
REDUCE INTERNAL
OF SKILL,
CONTINUOUS UPGRADATION
RAHUL MALIK
(CEO)
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Annex 5
ORGANISATION
CHART
MD
GM Works
Production
Manager
Dy Mgr
Prod
Sup. Mixing
Shift
I/C
HouseKeeping
Sup. Curing
Chief Mgr
(Maint)
Commercial
Manager
Q.C. Sup
Mech. I/C
Elect. I/C
Inspectors
Fitters
Electrician
Store
Asst.
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Personnel
Officer
Dy.Mgr
(Purchase)
Time
Keepers
Asst. Mgr
(Comm)
A/c
officer
Securities
W/H
Incharge
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Annex-6
ABBREVIATIONS
1. APQP
2. ASST.
- Assistance
3. ANNEX. - Annexure
4. CR
- Customer Representative
5. EDP
6. e.g.
- Example
7. FMEA
8. FIFO
9. GM
- General Manager
10. HOD
- Head Of Department
11. HR
- Human Resources
12. IA
- Internal Audit
13. IS
- Indian Standard
14. ISO/TS
15. MR
- Management Representative
16. MRM
17. MSA
18. CEO
19. SIPL
20. MGR
- Manager
21. NC
- Non Conformity
22. NCM
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- Number
24. PPAP
25. PO
- Purchase Order
26. QA
- Quality Assurance
27. QC
- Quality Control
28. QMS
29. QSM
30. QSP
31. REF
- Reference
32. Rs.
- Rupees
33. RN
- Revision Number
34. SPC
35. Sup.
- Supervisor
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