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: PI-QM-08
QUALITY MANUAL Rev. No.: 01
Rev. Date: 20.03.2019
OPERATION Page 1 of 22
8.0 OPERATION
8.1 Operational Planning and Control.
Development I/C & Proprietor are responsible for Product development activity as per procedure for
engineering. APQP reflects the structured approach followed for new product development. The
evidence & planning of each activity can be seen through timing plan itself
Product realization activities will be planned for new product or change in existing process. Each activity
defined in APQP timing plan will have activity description, Responsibility and target date defined.
During preparation of new product development Product realization time plan for new parts (APQP
timing Plan),
Development I/C has ensure that determination of as appropriate,
The process planning and activities are carries as per the APQP Planning Chart and Process chart for
Engineering Activity.
Quality objectives and requirements for the product and service.
Need to establish processes, documents and provide product and service specific resources.
Required verification, validation, monitoring, inspection and test activities specific to product and
service are determined in quality plan and acceptance criteria are also defined and documented.
Quality Plan, production planning & order review documents provides the evidence of product &
service realisation processes and resulting product and service are met with the requirements.
as an evidence that new product meets all customer requirements
8.1.2 Confidentially
Development I/C will ensure that Confidentiality of customer’s drawing, technical specification, product
design & product at the time of new product development, as well during continual production is
maintained. Development I/C will maintain confidentiality by making it as a policy not to hand over the
complete above mentioned design data/ information to one particular supplier & also no technical
information will be provided to any of our customer’s competitor.
The outsourced suppliers are not given any customer drawings or specifications.
PI will validate through production runs, benchmarking studies, or other appropriate methods, their
ability to make product to specifications at the required rate.
8.2.3.2
Proprietor will maintained the documented information for the Result of the Review of requirement for
repeat/ regular product and service will be done and details are documented in the PO / order
acceptance.
Review of requirement for new product and service will be and details are documented in the Team
feasibility study for new product and Service
PI will manage the interfaces between different groups involved in design & development to ensure
effective communication and clear assignment of responsibility
Planning documented Information will be updated, as the design & development progresses.
8.3.2.1 Design and development planning - supplemental
Development I/C will ensure that design and development planning includes all affected process owner
Within the PI and, as appropriate, its supply chain. Development I/C using CFT approach for following
stages:
a) Project management through APQP timing chart
b) Product and manufacturing process design activities through PFMEA, such as consideration of the
use of alternative designs and manufacturing processes;
c) Development and review of manufacturing process risk analysis through PFMEA, PFC, control Plan &
SOP/WI.
Top Management will ensure that CFT includes the organization's design, manufacturing, engineering,
quality, production, purchasing, supplier, maintenance, and other appropriate functions'
8.3.4.1 Monitoring.
Regular Reviews & Measurements will be done to ensure that the product meets the customer
requirements & the activities are carried out as defined.
Development I/C Verifies outputs in accordance with the planned arrangements to ensure the Design &
development outputs meet the Design & development inputs. Development I/C approve the drawings,
and other design documents. Documented information of the results of reviews, verifies and any
necessary actions will be maintained. As per Control Plan, validation of product is carried out like
Inspection & Testing, Process Audit. Product audit Documented information of validation and necessary
actions will be maintained.
In PI the Design & Development Validation will be performed in accordance with customer requirements
such as drawing, technical specification sheet, delivery schedule requirements which are reflected in the
APQP timing Chart.
Purchase manager has ensuring that purchased products conform to the specified purchase
requirements and purchasing activity is carried out as per procedure flow chart for purchasing process
Procedure for supplier selection, evaluation & re-evaluation is explains the detailed criteria for selection,
evaluating & re-evaluation of supplier. Refer Procedure for supplier selection, evaluation & re-
evaluation.
Suppliers are categorized A, B, C, D such as A-Critical, B-Major, C-Consumable, D-Accessories supplier
(Maintain more than 3 supplier for each material in each category).
List of approved suppliers explains the control exercised on each supplier, basis for type & extent of
control, needs & expectations are, the nature of manufacturing carried out by supplier & the further
operation that could be carried out in PI. Based on the performance of the supplier over a period of
time, flexibility will be given in control. Maintain the documented information for Black listed/D-Listed
supplier in NC register.
Other supplier selection criteria that should be considered include the following:
volume of automotive business (absolute and as a percentage of total business);
financial stability;
purchased product, material, or service complexity;
required technology (product or process);
adequacy of available resources
design and development capabilities (including project management);
manufacturing capability;
change management process;
business continuity planning (disaster preparedness, contingency planning);
logistics process;
Customer service.
8.4.1.3 Customer-directed sources
When specified by the customer, the PI will purchase products, materials, or services from
Customer-directed sources. All customer approved supplier evaluated as per process chart for supplier
evaluation & re-evaluation
Planning of Purchasing is done based on the customer requirements and schedule by Purchase I/C, if
required. Outsourcing planning is done based on the customer requirements and schedules, if required.
PO / Verbal is the mode of communicating Purchasing information; however product details, type
of process & schedule is communicated through PO or verbal/email/ written schedule.
Purchasing information includes as appropriate
a) Requirements for approval of product and service, procedures, processes and equipment,
b) Requirements for competence , qualification of personnel, and
c) Quality management system requirements.
d) Applicable statutory and regulatory requirements.
e) Inspection / Verification method of PI or customer requirements.
Purchase I/C ensures the adequacy of specified purchase requirements prior to their communication to
the supplier.
8.4.3.1 Information for external providers - supplemental
The Purchase I/C will pass down all applicable statutory and regulatory requirements and special
product and process characteristics to their suppliers and require the suppliers cascade all applicable
requirements down the supply chain to the point of manufacture'
Documented information Reference:
Procedure for Supplier evaluation & re-evaluation
Incoming Quality Plan
Supplier QMS Audit Plan
Supplier QMS Audit Report.
Supplier end performance report
i) Validation and periodic re-validation of Curing (heating) processes & painting process for production
and service provision. Validation will be done to demonstrate the ability of these processes to
achieve planned results.
a) Carry out job set up when the new product developed /Initial run of a job , Job changed/new set up
made, materials changed and first samples are taken, it is treated as the set up.
b) During set-up approval process and product characteristics will be checked and documented
information maintained in set up approval report
c) use statistical methods of verification, where applicable
d) perform first off/last off part validation, as applicable; where appropriate, first-off parts should be
retained for comparison with the last-off parts; where appropriate, last-off-parts should be retained for
comparison with first off parts in subsequent runs;
Quality I/C will verify the samples from the same. If any discrepancy, the appropriate action will be
taken. Job set up instructions are made available in SOP. Production I/C Job set-ups are carried out as
per work instructions established in SOP.
g) The Development will implement a system to monitor these activities if any work is outsourced.
Customer-owned Mould, manufacturing, test, inspection tooling and equipment will be permanently
marked so that the ownership of each item is visible, and can be determined. All the customer owned
tooling has been permanently marked with ownership mark such as number plate/part no. Verified,
protected & safeguarded. If any customer property is lost, damaged or otherwise found to be unsuitable
for use, the same will be reported to customer & documented information maintained.
The Development I/C implement a system to monitor these activities if any work is outsourced.
Customer supplied intellectual property such as product specification, Product sample, drawing or
relevant technical literatures or personal data are also treated as customer’s property. In case wherein
customer has provided any property the same will be identified, verified, protected & safeguarded. If
any customer property is lost, damaged or otherwise found to be unsuitable for use, the same will be
reported to customer & documented information of correspondence will be maintained.
Any material received from customer is inspected & verified against the delivery Challan. Customer
property is identified by customer’s name with a tag. The customer property is stored in racks, so as to
avoid damage or deterioration & is maintained so as to ensure availability as & when required for use. In
case of any damage, loss, or unsuitable to use the same will be communicated to the customer &
documented information of the same will be maintained.
8.5.4 Preservation
Conformity of the product is preserved during Internal Processing and Delivery to the intended
destination. Preservation includes identification, handling, storage and protection.
Packaging of the products is done as specified by the customer or as defined by PI, so as to ensure safe
delivery to intended destination.
Storage and Protection of the Product is done by using adequate storage facilities such as, Demarked
Areas. Materials such as, Stainless steel, paints, thinner, sealant, hardware accessories used in the
organization are stored so as to ensure safety from in fire hazards.
Inventory:
The inventory management PI will maintain Minimum Stock level for raw materials and other materials
for production so as to ensure proper inventory turnover time and monthly inventory turnover ratio will
reviewed.
e) If any Specific requirement of customer for packaging, it will be taken care at the time of dispatch/
storage by dispatch supervisor.
f) Stores In-charge performs the conditional stock verification activity at planned intervals to verify
the condition of the material in stock. First in- First out (FIFO) system is utilized to ensure that stock
rotation takes place. Any obsolete or non-conforming material/ product will be controlled as per
the procedure for Control of NC product.
g) The inventory management PI will maintain Minimum Stock level for raw materials and other
materials for production so as to ensure proper inventory turnover time and monthly inventory
turnover ratio will reviewed in objectives. Store I/C maintain the raw material and child part stock
register & Bin cards to know the stock level at any interval.
analysis & validated as appropriate & approved before implementation. The review of Design &
Development changes will include evaluation of the effect of the changes on constituent products &
products already delivered.
Documented information of the results of validation & review of the changes & any necessary actions
will be maintained in the ECN & management review report.
ECN will maintained for the changes to part design, manufacturing location, or manufacturing process
8.6.4 Verification and acceptance of conformity of externally provided products and Services
Quality I/C inspect the incoming raw materials as per Incoming Inspection control Plan and maintain the
inward inspection report and raw materials or customer approval will take before processing and
maintain the production card throughout the manufacturing process.
Reworking will be done as per the instructions provided in the respective stage control plan by skilled /
appropriate personnel to meet the specified requirements. Reworked items will be taken up for re-
inspection. Documented information of reworking carried & re-inspection status will be maintained in
the respective N.C. register.
The Production I/C retain documented information on the disposition of reworked product including
quantity, disposition, disposition date, and applicable traceability information .