DOC. No.
QSM - 07
QUALITY SYSTEM MANUAL
REV. No. 00
MP PRODUCT REALISATION
DATE 01.01.2013
PAGE No. 1 of 4
7.1 PLANNING OF PRODUCT REALISATION
Realization of the product requires planning and development of the process necessary to carry out
the various operations. As such alignment of the process of planning for product realization along
with the other processes of QMS is done for satisfactory performance. In planning product
realization, the following are borne in mind to determine the appropriate requirements:
The organisation’s quality objectives and requirements of the product.
The various processes used, the documents generated and the resources utilized are
established and taken into account.
The product acceptance criteria which are determined, are then verified, validated,
monitored, inspected and tested to ensure conformity.
All records needed to provide evidence, that the realization process and the resulting
product meet specified requirements, are maintained.
Reference:
PURCHASE ORDER / SCHEDULE – Customer, ENQUIRY REGISTER (F-MKT-04),
CONTRACT REVIEW(Purchase order ,Customer DC), SUPPLIER RATING RECORD (F-PUR-
06), STOCK REGISTER (F-STR-04), DAILY PRODUCTION PLAN, (F-PDN-03), FINAL
INSPECTION REPORT (F-QA-08).
7.2 CUSTOMER RELATED PROCESSES
7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT
The organisation has determined the following.
The various requirements specified by the customer, including the requirements for
delivery and post delivery activities.
Requirements not stated by the customer but necessary for specified or intended use
where known.
Statutory and regulatory requirements related to the product.
Any additional requirements determined by the organisation.
Reference:
PURCHASE ORDER / SCHEDULE - Customer
ENQUIRY REGISTER (F-MKT-04)
7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT
It is the practice of the organization to regularly review the various requirements related to the
products manufactured through internal meetings. This review of requirement is conducted prior to
acceptance of any order, commitment for supply to the customer. The following are ensured during
this process.
All products related requirements are defined.
The differences if any, from the previously stated requirements of the customers are
clarified and resolved.
The organisation has the ability to meet the all defined requirements. Records of all
reviews and action arising from them are maintained for reference.
All contract points are reviewed and recorded in the Customer purchase order.
Reference:
PURCHASE ORDER / (Customer)
CONTRACT REVIEW (Purchase order, Customer Dc)
PREPARED BY APPROVED BY
DOC. No. QSM - 07
QUALITY SYSTEM MANUAL
REV. No. 00
MP PRODUCT REALISATION
DATE 01.01.2013
PAGE No. 2 of 4
7.2.3 CUSTOMER COMMUNICATION
The organisation has established and maintained effective arrangements for communication with the
customers in relation to
Product information,
Enquiries, Contracts or order handling, including amendments, and
There is an effective customer feed back system where all the appreciations and
depreciations on the products and any other complaints if so happens are recorded and
communicated to all concerned persons, so that they are discussed and corrective actions
taken
Reference:
CUSTOMER SATISFACTION SURVEY (F-MKT-02)
CUSTOMER COMPLAINT REGISTER (F-MKT-03)
7.3 DESIGN AND DEVELOPMENT
The products are manufactured as per the Customer’s drawing. Hence this clause is excluded.
7.4 PURCHASING
7.4.1 PURCHASING PROCESS
The organisation will ensure that purchased product conforms to specified requirements.
The type and extent of control on the purchased product is defined, based on the effect of the
purchase on the final product.
‘List of Suppliers’ is maintained for approved suppliers.
Suppliers are approved on the basis of Price, Credit Period, Delivery time and Quality.
Monitoring their ability and rating the approved suppliers on a yearly basis will be followed
at the Organisation, which would enable deleting the names of suppliers - from the ‘List of
suppliers’- who do not perform to acceptable norms.
Reference:
LIST OF APPROVED SUPPLIERS (FPUR-01)
SUPPLIER RATING RECORD (F-PUR-05)
STOCK REGISTER (F-STR-04)
7.4.2 PURCHASING INFORMATION
The requirements of the product will be detailed in the ‘Purchase requisition
clearly specifying and describing the required specifications.
Reference:
PURCHASE REQUISITION & VERIFICATION (F-PUR-03)
LIST OF APPROVED SUPPLIERS (F-PUR-01)
7.4.3 VERIFICATION OF PURCHASED PRODUCT
The Organization verifies the purchased products to ensure the requirements specified in the
Purchase requisition are met.
PREPARED BY APPROVED BY
DOC. No. QSM - 07
QUALITY SYSTEM MANUAL
REV. No. 00
MP PRODUCT REALISATION
DATE 01.01.2013
PAGE No. 3 of 4
Reference:
PURCHASE REQUISITION & VERIFICATION (F-PUR-03)
7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION
To enable timely delivery of quality products, the Organisation decides on a ‘Daily
Production Plan’ based on the Customer Schedule.
‘Control Plan’ is prepared ,defining the production process.
Machines having necessary capability are only used for production.
The production process is monitored and controlled to ensure that the product conforms to
specified requirements.
Criteria of workmanship are displayed where objective measurement is not possible.
The equipments are maintained suitably to ensure continued process capability.
Reference:
DAILY PRODUCTION PLAN (F-PDN-03)
CONTROL PLAN (CP-XXX))
FINAL INSPECTION REPORT (F-QA-08)
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
The organization doesn’t have any process where the resulting output cannot be verified by
subsequent monitoring. Hence this clause is excluded.
7.5.3 IDENTIFICATION AND TRACEABILITY
Products at all stages are identified with tags and accompanying documents.
Materials in store are identified and stored separately in racks.
The entire semi finished is stored in ‘work in process’ area and identified with tag. Rejections
are stored in Nonconformance area and identified with tag.
Finished products are stored in dispatch area and identified with tag.
Where traceability is a specified requirement the same is established which are available
through the records. Inspection and Test status is identified throughout production and
dispatch of the product.
Reference:
STOCK REGISTER (F-STR-04)
IDENTIFICATION TAGS
7.5.4 CUSTOMER PROPERTY
Customer properties such as raw materials are received, processed and returned back safely
to the customer.
The status of the above is recorded in the stock register.
Intellectual properties of customers are available (eg: Product Drawings, Purchase Orders,
Customer Schedule and Correspondence letters) and It is kept safely for reference purpose.
Reference:
PRODUCT DRAWING,
PURCHASE ORDER AND CORRESPONDENCE LETTER (CUSTOMER)
PREPARED BY APPROVED BY
DOC. No. QSM - 07
QUALITY SYSTEM MANUAL
REV. No. 00
MP PRODUCT REALISATION
DATE 01.01.2013
PAGE No. 4 of 4
7.5.5 PRESERVATION OF PRODUCT
The conformity of the product is preserved during in-house processing and delivery to the
intended destination.
This preservation includes identification, handling, packaging, storage and protection.
Suitable trays are provided for preventing damage to products, while handling.
Suitable storage areas are provided for incoming materials and finished products.
Stocks are monitored on a daily basis.
Finished products are delivered in the trays applied with rust prevention oil
Final inspection report and delivery chalan are made available for the verification at the time
of delivery.
Reference:
STOCK REGISTER (F-STR-04)
7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT
At the organisation, all the identified ‘Monitoring and Measuring Equipments’ (MME), are
controlled, calibrated and maintained.
Suitable MME are identified for ensuring the conformance of products to specifications at all
stages of production.
All MMEs are identified with a unique number.
Instruments are calibrated at specified intervals by external agency. The calibration is done
against standards traceable to any national or international standards.
Equipments, whenever found to be out of calibration are rectified by adjustments or
readjustments wherever necessary, prior to their use.
Care is also taken to ensure that the calibration of the equipment remains valid during use. It
is ensured that the setting and adjustments do not get disturbed, invalidating the
measurements made. This safeguard of the instrument ensures its accuracy, and its fitness for
use continues throughout the period, till the next calibration is due or done.
When the equipment in use are found being used without calibration, they are not only
rectified or scrapped, but also the previous measurements carried out in the process are
reassessed and the results are documented as observed.
Calibration reports obtained from the external agencies are verified.
No software is used for measuring and monitoring of product/ process.
Reference
F - IMNT - 05 MASTER LIST OF TESTING AND MEASURING EQUIPMENTS
F -GMNT - 06 MASTER LIST OF GAUGES
F - IMNT - 07 HISTORY CARD OF TESTING AND MEASURING EQUIPMENTS
F - CMNT - 08 CALIBRATION MONITORING CHART
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