Professional Documents
Culture Documents
VHV/QM/A Rev. 00
Quality Policy
VHV PRECISION ENGINEERING Believes
In Achieving Excellence Through
Continual Improvement In Our
Products, Process & Systems.
Prepared by Approved by
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VHV PRECISION ENGINEERING
Quality Manual Context of the organization
Ref.:ISO 9001:2015, clause 4 Section: VHV/QM/4 Rev. No. / Date : 00/01.06.2022
General Policy :
It is the policy of the company to establish, document, implement and maintain a Quality Management
System and continually improve its effectiveness and efficiency in accordance with the requirements
of ISO 9001:2015 standard.
Scope :
Applicable to entire system relating to ISO 9001:2015 requirements. Identification of internal &
external issue.
Managing Director, Vice President, Sr.GM Project, and all concerned Head., MR : For day to day
affairs.
Description:
The company has determine external and internal issues that are relevant to its business
purpose , direction & affect its ability to achieve the intended result of its quality management system.
The company has monitor & review information about these external & internal issues with
consideration of following factor:
Issue can include positive and negative factor or conditions for consideration.
Understanding the external context can be facilitated by consideration issues arising from
legal, technological, competitive, market, cultural, social & economic environments,
whether international, national, regional or local.
Understanding the internal context can be facilitated by consideration issues related to
values, culture, knowledge and performance of the organization.
Company has determine the effect or potential effect on the organization’s ability to
consistently provide products and service that meet customer and applicable statutory &
regulatory requirements, the organization determined following :
Company consider the effect or potential effect for following interest parties:
Requirement & effect or Potential effect of above interested parties address in List of Interest parties
with their need and expectation.
Company address the monitoring & review information for all above interest parties in quality manual,
procedure, Drawing, Work instruction, Certificate ,Control plan & quality plan
The company has determined the scope of the quality management system .
When determining this scope, the organization shall consider following factor :
Scope : Manufacturer and Export of Forged, Cast & Precision Machined Components.
Since the customer is design responsible who gives the design records, the clause 8.3
Design and development does not apply. However the Product quality planning team
assesses the feasibility of the proposed design at the time of product quality planning as per
the Processing of development of new parts.
The company also ensures to continually improve its effectiveness in accordance with the
above-mentioned standard.
The company has carried out following activities to implement the quality management
system.
o Has identified the processes needed for the quality management system and
determined the sequence and interaction of these processes, which are addressed in
the various sections of this manual. For the simple understanding of processes, flow
process charts are used in the Annexure .
o Has determined criteria and methods required ensuring the effective operation and
control of this processes in the respective procedures and control plans.
Company controls those processes, which have been outsourced by providing adequate
information to the suppliers and its verification of its arrival at the company.
Company takes the responsibility of conformity to all customer requirements of all the
outsourced processes and this has been identified within the scope of quality management
system.
At present company not carry out any job works at outsourced. These outsourced processes
do affect the conformity of the final product and the controls of this process is defined in
Control plan/Drawing. Issue of the Drawings to Supplier. Drawing used for production by the
suppliers.
Statutory & regulatory requirement related to supplier/job work process cover in supplier
registration form.
Determined criteria and methods required ensuring the effective operation and control of the product
safety in the procedures for product safety.
a) Documented information identify in process turtles of each process capturing in process map.
b) Retention time of documented information define in list of records.
c) MD ensures that quality objective, are established at relevant functions and levels within the
organization. It shall be measurable and consistent with the quality policy.
d) Quality Objectives or KPI defined in Annexure 2.
Reference Document :
Purpose:
VHV PRECISION ENGINEERING has always believed in excellence in all areas of operation through
services of high quality and values. Our strength lies in responding to the customer needs. We have
strived to bring the best possible technologies, methodologies, manpower and equipments to ensure
customer satisfaction.
VHV PRECISION ENGINEERING is committed to total quality at all levels. We believe in high quality
services at an economic price. We upgrade the quality of our services not just on a one time basis,
but as part of an ingrained culture, which drives us to make continuous improvements.
VHV PRECISION ENGINEERING is now taking a new positive step towards total quality by
establishing a documented Quality policy. We are sure that the spleen did and innovative efforts of
our employees and their commitment to Quality would ensure our Company continuous progress.
VHV PRECISION ENGINEERING aims at not only achieving Customer satisfaction by meeting
specified quality requirements but also enhancing the same through continual improvement of quality
levels.
1) Top Management: Top management is responsible to analyze the company level data with
help of employees and respective Managers and based on the analysis and discussion to establish
objectives and policy.
Top management is also responsible to assess the resources availability and their utilization
including the human resources.
The top management has taken strategic decision to implement and to improve it continually to
achieve higher standards of effectiveness and efficiency.
Description:
5.1 : Leadership & commitment
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VHV PRECISION ENGINEERING
Quality Manual Leadership
Ref.: ISO 9001:2015, clause 5 Section: VHV/QM/5 Rev. No. / Date : 00/01.06.2022
Vice President has define and implement corporate responsibility policies which including of
minimum an anti-bribery policy, an employee code of conduct and ethics escalation policy.
CSR Policy and code of conduct is established as per Annexure 5 of this manual.
Top management has defined the measures of process efficiency and effectiveness in
the respective Processes.
Top management reviews the product realization process and support processes in the
management review meetings to assure their effectiveness and efficiency, with respect
to the defined quality Objectives.
5.1.1.3 : Process owners
Outputs of all the above requirements are met with the aim of enhancing customer
satisfaction.
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VHV PRECISION ENGINEERING
Quality Manual Leadership
Ref.: ISO 9001:2015, clause 5 Section: VHV/QM/5 Rev. No. / Date : 00/01.06.2022
5.2 Policy
Top management has made the Quality policy, which contains the purpose of the
organization in satisfying the customer needs and expectations. (Refer Annexure I for
the Company’s quality Policy).
The company’s Quality Policy statement is signed by the MD.
Company’s Quality policy reflects its commitment to comply with requirements and
continually improve the effectiveness of the Quality Management System includes
customer satisfaction.
It also provides a framework for establishing and reviewing Quality objectives.
Quality policy is reviewed (at least once in year) in management review meetings for its
continuing suitability.
5.2.2 Communicating the Quality policy
Responsibility and authority are defined in the Quality management system and communicated to the
concerned within the organization.
Company’s organization structure is as per the Annexure III of this manual
Responsibilities and authorities are defined in the Annexure of this manual and
communicated to the concerned within the organization.
Production Manager, who is responsible & authorized for taking corrective action, is promptly
informed of products or process, which do not conform to requirements.
Quality Manager who is responsible for product quality is given authority to stop production to
correct quality problems
Section Head across all shifts are staffed with personnel in charge of or delegated
responsibility (ref appendix) for ensuring product quality.
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VHV PRECISION ENGINEERING
Quality Manual Leadership
Ref.: ISO 9001:2015, clause 5 Section: VHV/QM/5 Rev. No. / Date : 00/01.06.2022
Top management has appointed Mr. Kalpeshbhai are member of management , irrespective of
other responsibilities, has responsibility and authority that includes
Ensuring that processes needed for the quality management system are established,
Implemented and maintained
Reporting to top management on the performance of the quality management system and
any need for improvement
The responsibility of a Management representative includes liaison with external parties on matters
relating to the quality management system
Top management has designated responsibility and authority to the following personnel to ensure
that customer requirements are addressed
Responsibility and
Requirements
authority
Selection of special
Development Manager
characteristics
Customer
Marketing Manager
scorecards/Complaint
5.3.2 Responsibility and authority for product requirements and corrective actions
Supervisor for all shift are authorized to stop production and correct quality problems.
Supervisor for both shift have responsibility for ensuring conformity to product requirement.
Supervisor have responsibility and authority for corrective action on product or processes that
do not confirm to requirements to ensure that non conforming product is not shipped to the
customer and also keep separate of all potential non conforming product produce.
Reference Document :
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VHV PRECISION ENGINEERING
Quality Manual Leadership
Ref.: ISO 9001:2015, clause 5 Section: VHV/QM/5 Rev. No. / Date : 00/01.06.2022
Prepared by . Approved by
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VHV PRECISION ENGINEERING
Quality Manual Planning
Ref.: ISO 9001:2015, clause 6 Section: VHV/QM/6 Rev. No. / Date : 00/01.06.2022
Purpose:
This section outlines is to balance the risk and opportunities for all process for that provide
resources including human resources, infrastructure, work environment etc. To determine and
provide resources needed to quality Management System, address risk and opportunity and
continually improve its effectiveness and to enhance the planning through effective contingency
plan.
Description:
The planning of the quality management system, the company considers the internal & external
issue and the requirement related to risks and opportunities that need to be addressed in process
turtles.
Give assurance that the quality management system can achieve its intended result.
Enhance desirable effects – Opportunity
Prevent or reduce, undesired effects – Risk
Achieve improvement
Risk & Opportunities are identifying by SWOT analysis & Process wise Risk Analysis.
(a) The uses of appropriate sources for information such as processes and work operation
which affect product quality, concessions, audit results, records, customer complaints
and data analysis to detect, analyze and eliminate potential causes of non conformities.
(b) Determining the steps needed to deal with any problems requiring preventive action.
(c) Initiating preventive action and applying controls to ensure that this is effective.
(d) Ensuring that relevant information on actions taken including changes to procedure is
subjected to management review.
The company maintain records of corrective and preventive actions taken and their results. If any
action is found to be effective, is may be implemented on permanent basis.
The company implements and records any changes in the documented procedures resulting from
corrective and preventive actions.
Self Assessment done as per procedure for continual improvements supports this objective of
taking preventive actions and aims at making all processes best in class with special focus on key
processes
Identify & evaluate internal & external risk to all manufacturing processes and infrastructure
equipment essential to maintain for production output and ensure that customer
requirements are met.
According to risk and impact to the customer.
Contingency plans for continuity of supply in the event of any of the following
1 Key equipment failure
2 Interruption from externally provided products, processes and service;
3 Recurring natural disasters.
4 Fires
5 Utility Interruptions
6 Labor shortages
7 Infrastructure disruptions
Contingency plans also include a notification receive from the customer and other
interested parties for the extent and duration of any situation impacting customer operation.
Contingency plan test once per year for effectiveness.
Contingency plan review once in year by MDT and update as required.
Contingency plans keep and retain as documented information describing any revision and
Production Manager having authority for changing the Contingency plan.
Contingency plan shall include the provisions to validate that the manufactured product
continues to meet customer specification after the re-start of production following an
emergency in which production was stopped and if the regular shutdown processes were
not followed.
It shall be
a) measurable and
b) consistent with the quality policy
c) account applicable requirement
d) relevant to conformity of product and enhancement of customer satisfaction.
e) Monitored
f) Communicated through meeting & display.
g) Update as appropriate.
6.2.2 Following plan carry out for achievement of quality objective, the organization shall
MD ensures that quality objectives are established at relevant functions and levels within the
organization.
Quality objective include the customer specific requirement.
Quality objective result review once per year by MD.
Customer target also taken in quality objective and monitored it.
Top management has identified the resource requirement on basis of each processes
requirement, risk and opportunity and customer requirement.
Company shall consider the following point in plan of change
Reference Document :
1) Business Plan
2) Contingency Plan
3) Process Wise Risk Analysis
Purpose :-
To plan and develop the processes needed support are implement for operation activity.
M.R. : He is overall responsible for the control of documents and records and having authority to
review, approve and re-approve the same.
Quality Manager: He is overall responsible for the calibration activity.
HR Manager: He is overall responsible for the awareness, competence, motivation &
Organizational knowledge.
Description:-
7.1 Resources
7.1.1 General
Top management has provided resources required for Implementing and maintaining the quality
management system and for continually improving its effectiveness, including
o Potential consequence.
Resource requirements are identified and provided with respect to the following, to meet their
requirements, for enhancing the customer satisfaction
o Customer requirement (Ref. Purchase order, Customer drawings, Customer manuals &
Standard and)
o Customer feedbacks (Customer complaints, Customer Satisfaction survey, etc)
7.1.2 People
Top management identifies person necessary for the effective implementation of its quality
management system and for operation and control of it processes.
Person requirements are identified and provided with respect to the following, to meet their
requirements, for enhancing the customer satisfaction
7.1.3 Infrastructure :
MDT determines the infrastructure like buildings, workspace and associated utilities like
machineries, fixtures, measuring equipment, process equipment and supporting services such as
transport or communication technology, including hardware & software & associated utilities
needed to achieve conformity to product requirements.
Company provides the infrastructure needed to achieve conformity to product requirements, in the
Management review meetings.
Following are the personnel assigned responsibility for maintaining the following utilities.
Company uses a cross functional team for developing plant, facility and equipment plans.
MDT reviews the plant layout for the optimization of material travel, handling and value-added use
of floor space including control of non conforming product, synchronous material flow, during the
development of new products.
MDT developed and implemented to evaluate manufacturing feasibility for new product or new
operation.
MDT review and include the capacity planning in Manufacturing feasibility assessment.
MDT maintain process effectiveness, including periodic re-evaluation relative to risk incorporate
any changes made during process approval, control plan maintenance and verification of job set-
ups.
Overall equipment effectiveness (OEE) are monitored and evaluated for the effectiveness of the
existing operations.
The organization determines and manages the work environment needed to achieve conformity to product
requirements in the Management review meetings
Company has provided safety devices including gloves, hoist, fire extinguishers etc as a means to
minimize potential risks to employees in the manufacturing process activities
Section head has responsible for maintaining the premises in a state of order, cleanliness and
repair consistent with the product and manufacturing process needs.
Manager – Quality determine the monitoring and measurement to be undertaken and the
monitoring and measuring devices needed to provide evidence of conformity of product to
determined requirements in the Control plans.
The company has processes to ensure that monitoring and measurement can be carried out and
are carried out in a manner that is consistent with the monitoring and the measurement
requirements. Manager – Quality selects the instruments, which are to be calibrated and entered
in the Calibration History Card (As mentioned in applicable records).
Note: Company laboratory has a well defined Laboratory Manual defining the lab policy, scope,
standards used and the applicable work instructions and calibration procedures etc.
Instrument Calibration Plan as per List of Instrument with Calibration Frequency. Calibrated
Instrument Identified as per Monthly color code.
Collect the monitoring and measuring device from various locations for calibration as per the
schedule date mention in calibration History Card.
On the receipt of instrument for calibration, calibration is done and results are noted down in the
Calibration History Card.
External laboratory:
Company selects the external laboratories that are acceptable to the customer or a laboratory,
accredited to ISO/IEC 17025 or national equivalent, for calibration where in-house calibration
facility is not available.
External laboratory facility used for inspection, test or calibration service by the company shall
have a define laboratory scope that includes the capability to perform the requirement inspection,
test or calibration.
Company obtains the laboratory scope from the external laboratory showing that they have the
capability to perform the required calibration. Manager – Quality arranges to send instruments for
calibration as per the frequency decided.
Calibration service may be performed by the equipment manufacturer when a qualified laboratory
is not available for a given piece of equipment in such case the organization shall ensure that the
requirements listed in control plan.
On receipt of the instruments after calibration from external agency, Standard room incharge
verifies following details:
o An assessment of the risk of the intended use of the product caused by the out of
specification condition.
When the equipment is found not to conform to requirements, Manager – Quality may assess the
validity of the previous measuring results, and inform the user department to assess the impact of
out of specification conditions.
Manager Quality informs the Marketing department, if suspected parts are dispatched to the
customer.
Manager Quality maintains the Calibration certificates received from the external laboratories, till
the equipment is used for the monitoring & measurement.
Errors in the measuring devices (if any) are communicated to the users to correctly read the
measurements taken. If required, they are sent outside to adjust or re-adjust.
Company ensures that the monitoring and measuring instruments are safeguarded from
adjustments that would invalidate the measurement result.
Company protects the monitoring and measuring instruments from damage and deterioration
during handling, maintenance and storage.
Since the Company does not use any computer software for the monitoring and the measurement,
the standard requirement of confirming and reconfirming the ability of computer software to satisfy
the intended application, is not applicable.
Statistical studies, including Gauge – Repeatability & Reproducibility, Bias, Linearity studies etc
are conducted to analyze the variation present in the results of each type of measuring and test
equipment system as identify in control plan.
All type of instrument, measuring and test equipment identified in the control plans is covered by
MSA studies.
Gauge – Repeatability and Reproducibility study is conducted for all the type of inspection,
measuring and test equipment to find out the appraiser as well as equipment variation.
Linearity study is planned to conduct for measuring instruments whose operating ranges are used
in the measurement of various product characteristics.
Attribute study is conducted for all types of gauges identified in the control plans.
Stability study is carried out for the equipment, whose frequency of calibration is more than 3
years.
The company gained knowledge for product conformities from past experience are below :
Internal Knowledge :
Customer Drawing
Control Plan
Customer audit result
Customer complaint
New product development
Work instruction
Machine manual
Past developed sample storage
Insert/tool selection book from supplier
Setup wise Program
External Knowledge:
Process wise Knowledge requirement and available shall be define in List of process wise Knowledge.
Management ensures that personnel performing work affecting product quality is competent on the basis
of appropriate education, training, skills and experience.
Company identifies necessary competence like expertise, skills etc for the personnel performing
the work affecting product quality, and is documented in Skill Matrix and skill available Vs skill
Required (gap Analysis) recorded in Skill Mapping.
Records of qualification and experience of each employee and their compliance with the skills
defined in the Skill Matrix are recorded in the Employee History Cards & skill available recorded in
skill mapping.
Training needs are identified in the Management Review Meetings, to provide necessary
competence based on the outcome of following processes.
Customer feedback
Training detail given for each individual are also noted down in the Training achievement &
evaluation report and effectiveness of the trainings is verified in the internal audits or asking
question to trainee.
Quality objectives are displayed at strategic locations in the company to make personnel aware of
their relevance and importance of their activities and how they are contributing to the achievement
of the quality objectives.
Company has established and maintained documented procedures for identifying training needs
and achieving competence of all personnel performing activities affecting product quality in the
Procedure.
Company ensures that personnel performing specific assigned tasks are qualified, as required,
with particular attention to the satisfaction of customer requirements.
Company provides on-the-job training to the personnel in any new or modified job affecting
product quality with respect to the skill matrix.
Personnel whose work can affect quality are informed about the consequences to the customer of
nonconformity to quality requirements.
Details of on the job training are recorded in the Training records and Training Effectiveness
assessment form record format.
Quality Management system auditor , Manufacturing process auditors and product auditor competency
cover min. of following point :
Understanding of the automotive process approach for auditing, including risk based thinking.
Understanding of applicable customer specific requirement
Understanding of applicable ISO 9001 requirement related to the scope of the audit.
Understanding of applicable core tool requirements related to the scope of the audit.
Understanding how to plan conduct report & close out audit findings.
Manufacturing process auditors have technical understanding of the relevant manufacturing
process.
Product auditor have understanding of product requirements and use of relevant measuring and
test equipment to verify product conformity.
Training detail given for each auditor for above subject are also noted down in the Training records and
effectiveness of the trainings.
Understanding of the automotive process approach for auditing, including risk based thinking.
Understanding of applicable customer specific requirement
Understanding of applicable ISO 9001:2015 requirement related to the scope of the audit.
Knowledge of manufacturing process to be audited, including PFMEA & control plan.
Applicable core tool requirements related to the scope of the audit.
Understanding how to plan conduct report & close out audit findings.
7.3 Awareness
Management ensures that personnel performing work under the organization control are aware of the
following:
The Quality Policy
Relevant quality objective
Their contribution to the effectiveness of the quality management system, including the benefits of
improvement performance.
Suggestion for not conforming with the quality management system requirement.
7.3.1 Awareness-Supplemental
HR Manager & Quality manager ensure that the all employees are aware of their impact on product quality
and the importance of their activities in achieving, maintaining and improving quality, including customer
requirements and the risk involved for the customer with non conforming product.
o Creates a competitive climate through recognition of good work, Award give & Award photo
o Conduct the employee motivation survey (Every 12 Month) and note down the details in
Company conducts employee surveys with the aim of employee motivation & empowerment.
This process includes the promotion of quality & technological awareness throughout the whole
company. Posters are displayed for this.
Company has a process to measure the extent to which its personnel are aware of the relevance
and importance of their activities and how they contribute to the achievement of the quality
objectives
7.4 Communication
Top management ensures that appropriate communication processes are established within the
organization and the communication takes place regarding the effectiveness of the quality management
system.
Where all documented procedures & formats are defined, they are used as a means in the communication
within the company. In all the other cases, communication is through verbal means.
Weekly meetings, management review meetings, Notice boards etc are used as means to communicate
among the functions, regarding the effectiveness of the quality management system
Quality Manual
Procedures/Activity chart
Level – 1
It includes the Quality manual, which provides and overview of the quality management system
considering the standard requirements. Procedures and Processes are defined and highlights in
respective Sections of the Quality manual.
Level – 2
It includes Procedures as required by this international standard and other documented processes. (e.g.
Management review process, Purchasing process, Production Planning process, etc.) Quality records
are defined and referred to, in respective procedures and / or processes.
Level – 3
It includes External standards, Work Instructions, Control plan, Drawing, etc, to ensure the effective
planning, operation and control of its processes.
Level – 4
It includes formats, forms, registers, etc. to provide evidence of conformity to requirements and of the
effective operation of the quality management system.
Documented system include a quality manual, which can be a series of documents (electronic or hard
copy)
The format and structure of the quality manual is at the discretion of the organization and will depend on
the organization size. culture, and complexity. If a series of documents is used, then a list shall be retained
of the documents that comprise the quality manual for the organization.
Approving authority reviews it and re-approves the new document, drawings, control plans.
Management Representative issues the new document to the concern, mentioning the current
revision & the latest changes in the master copy of the newly released document. Document
changes detail mention in amendment form.
Design I/c issues the new drawings against the obsolete drawings.
Management Representative & Design I/c takes back the obsolete copy from the user, and
disposed off and master copy of obsolete document are retain till the next revision.
If the obsolete copies are to be retained for any purposes, Management Representative identifies
it by putting red stamp of ‘OBSOLETE COPY’ on every page.
Documented information are identification, description, ref. No., Date, author shall define in
Procedure for control of document.
Current revision status of all documents is identified by revision number and or by effective dates
and is addressed in the Document & Record Distribution Sheet.
All the latest version of the applicable documents is issued to the relevant functions.
The documents are identifiable by its name and / or number and are neatly written to ensure the
legibility.
The documents of external origins are identified by their name and are distributed to relative
functions through Document & Record Distribution List.
Only latest version of documents is available with concern function. All the obsolete documents will
dispose by the person who has issued the same, to prevent its unintended use. In case, any of
the obsolete documents is required to be retains for any purposes, they are identified with the “
OBSOLETE COPY” stamp by the issuing authority.
Documented procedure for control of documents has been established to define the controls as follows.
o Following are the approving authority for the documents, who approves the documents on
reviewing its adequacy & legibility.
Master copies of original document are identified by the blue stamp of ‘MASTER COPY’ on backside of
every page of the document.
For the Issue of documents, drawings, W.I. (including documents of external origin):
Management Representative Issues related documents to the concerned persons by putting Blue stamp of
‘CONTROLLED COPY’ on the front side of every page for the document. Management Representative
maintains its issue details in the Distribution List, including the current revision status and the location in
which they are distributed.
All the documents are identified by no. and its contents and also through its revision number and effective
date.
1. The numbering system shall be mentioned in Procedure for control of document.
2. MR shall ensure that all the documents numbered is as per the numbering System mentioned
above.
o Documents, which are maintained in the computers, are controlled through passwords.
o Documents, which are maintained in the computers, are controlled through passwords.
Quality records are identified by their no. as per the documented procedure for control of records &
are referred in the respective sections of this manual & list of record.
Quality records are made legible and are kept in files and are indexed for the easy retrieval.
Various files are named by the quality records and are arranged systematically at the user
location, for the easy access to the user.
Retention time of all the quality records is addressed in the list of record, which satisfies statutory
regulatory, organizational and customer requirements as applicable.
All the quality records are retained for the period as per the defined retention time and are
disposed off subsequently by the person responsible for retention.
Production part approval, tooling records, product and process design records, purchase orders or
contracts and amendments shall be retained for the length of time that the product is active for
production requirements, plus one calendar year, unless otherwise specified by the customer or
regulatory agency.
Quality records are protected from damage, loss and deterioration while on storage by the user.
o Records, which are stored in the computers, are protected by taking backups to protect
the loss of the data till its retention period.
o Records that are maintained in the computer are protect by user password.
Reference Document :
Purpose :-
The purpose is to plan and implement the monitoring measurement, analysis and improvement
processes needed to demonstrate the conformity of the product, to ensure conformity of the quality
management system and to continually improve the effectiveness of the quality management system.
Production Manager: - For the monitoring and the measurement of the product, control of non-
conforming product and authority to dispose the non conforming product.
Quality Manager: Responsibility of product identification and traceability, control and monitoring of
measuring .
Description:-
8.1 Operational planning & control/8.1.1 Operation planning and control - supplemental
Company plans and develops the processes needed for product realization, whenever new
products are to be developed or when there is a major change in the existing product.
Company ensures that planning of product & service is consistent with the requirements of
the other processes of the quality management system.
o Company reviews the quality objectives and may update it, if required.
o Manufacturing Process FMEA is carried out for the entire customer designated special
Characteristics.
o Company determines the requirements for the product and is addressed in the Control plan
Manufacturing process FMEA outputs are taken in to account in the Control Plan.
Control plans are developed for all the parts at various stages starting from receiving to the
final.
o Control method
Customer requirements and references to its Technical specification (Drawings) are included
in the control plans.
Acceptance criteria are defined in the control plans. If required it is sent to the customer for its
approval before the PPAP lot submission. For the attribute data sampling, acceptance level is
taken as zero defects and are mentioned in the control Plans.
Control plans are reviewed and updated when any change occurs effecting product,
manufacturing process, measurement, supply source or FMEA.
Company reviews the existing processes and documentation with respect to the specific
requirement of the product and if necessary, it establishes new processes or modifies the
existing processes.
Company also determines and provides new resources requirement like machineries, fixtures,
qualified personnel etc, specific to the product.
Company determines verification, validation, monitoring, inspection and test activities specific
to the product and the criteria for product acceptance and is addressed in the control plan.
Records (like inspection/test records, SPC records, etc.) are maintained to provide evidence
that the realization processes and resulting product meet requirements.
Company also ensures that the output of this planning is in a form suitable for the company’s
methods of operations.
Company controls those processes, which have been outsourced by providing adequate
information to the suppliers and its verification of its arrival at the company.
Company takes the responsibility of conformity to all customer requirements of all the
outsourced processes and this has been identified within the scope of quality management
system.
8.1.2 Confidentiality
Confidentiality of customer contracted products and projects under development and related
product information is ensured.
The Company has implemented effective arrangements including FAX, Telephone, language
agreed with customer and Internet (Email, Website) for communicating with customers in
relation to
o Customer –specified computer language and format (e.g. computer –aided design
data, electronic data interchange)
Company maintains a computerized system for the receipt of customer planning information
and ship schedules.
8.2.2 Determining the requirements for products and service/8.2.2.1 Determining the
requirements for products and service – supplemental.
Company provides technical details for it’s product range and existing customer, technical capability ,
and its specifications/application are briefed in the same.
Inquiry receive from customer with drawing recorded in inquiry status report and quotation sending
detail mentioned in inquiry status report.
Marketing Manager & development conduct feasibility study of customer inquiry and get approval from
MD and accordingly prepared quotation and send to customer.
M.D. & Manager Marketing receives delivery requirements including timing, quantity, recycling,
environmental impact and characteristics identified and transportation mode are received from the
customer. Presently post delivery activities are not a requirement, hence not addressed.
Requirements not stated by the customer but necessary for specified or intended use, where known,
are take care by the Company.
Also company take care for following requirement but not to be limited.
All applicable government,
Safety
Environmental regulations related to acquisition,
Storage, Handling, Recycling, Elimination or disposal of material.
Presently, any authorized bodies do not prescribe any statutory and regulatory requirements related
to the product. However, we shall address this, whenever it is required so.
b) Company resolves with the customer if any of the contract or order requirements are differing from
expressed.
8.2.3 Review of the requirements for products and services/8.2.3.1.1 Review of the
requirements for products and services-supplemental , 8.2.3.1.2 Customer designated special
characteristic 8.2.3.1.3 Organization manufacturing feasibility
o On receipt of inquiry for the new product, Manager Marketing notes down the details in
the Enquiry – Order Review Form and MDT Leader carry out the Team feasibility
commitment to review requirement related to the new product and to ensure
manufacturing feasibility including risk analysis of the proposed product.
o Manufacturing feasibility conduct for new product/new process & new technology or any
change in manufacturing process or product design.
o In the risk analysis CFT/MDT assess the following to effectively & efficiently provide the
customer specific requirements of the proposed product or changed process or product
design…
Manufacturing capacity
Based on the feasibility study (risk analysis) on the above points, Asst. Manager Marketing &
Development manager takes the decision of whether the product is to be developed or not.
Team Leader conducts the team feasibility study with multi disciplinary team and results of study is
communicates to the Manager Marketing to communicate to customer.
Team leader validate through production runs, bench marking studies or other appropriate methods ,
Ensure the ability to make product to specifications at the required rate.
Team Leader uses the APQP / MDT Responsibility Matrix & Timing Chart for the feasible products for
execution of new product development as per the customer-timing requirement.
o Upon the receipt of the customer order, (written), Manager Marketing reviews the
requirements related to the product, including the product specifications, timing and
quantity requirement, packaging, transportation requirement etc and Manager - Marketing
shall acknowledgment the order by email same shall be add in customer order
monitoring sheet.
o Mgr. Marketing resolves with the customer if any of the contract or order requirements are
differing from those previously expressed.
o Asst. Manager Marketing receives schedule from customer (OEM) for regular order &
review the same for delivery with Managing Director, Technical Director and Executive
Director, if required.
o Status of the pending order shall be monitored through Computer system. Asst. Manager
Marketing shall inform to customer change in schedule if delay.
o Order Amendments: Mgr. Marketing shall process any amendment in the customer’s
order after any change in tech./ Commercial terms for the product, review & amendment
to contract and request to customer for P.O. Amendment (if applicable).Customer revised
P.O. received and P.O. accepted status inform to customer by email. Revised order detail
communicate to PPC.
Mgr. Marketing contacts the customer, if any of the requirements are not clearly defined or
understood.
Records of the results of the review and actions arising from the review (Team feasibility form,
customer communication on schedule matters, Management review) are maintained.
If customer given any authorized waiver for the requirements stated shall be keep as
document information for review.
Manager Marketing prepared the Daily Dispatch Advise Form and gives to dispatch incharge.
Asst. Manager Marketing monitors the actual dispatches with the committed in the Daily
Delivery Performance Monitoring – Product Wise.
Asst. Manager Marketing presents the Customer & Product wise delivery performance report
in Management review meetings.
Production planning
Manager Marketing shall prepared tentative production plan on the basis of customer
schedule, pending order and order received from OEM in consultation with M.D. and G.M.
(Operation).
On the basis of tentative production plan and availability of the material, PPC I/c & Production
I/c. shall prepared production plan on monthly basis.
Make monthly production plan of components before the starting of month in 'Monthly
Production Schedule Cum Production Performance Monitoring.'
Based on orders and stock, component planning is carried out than release P.O. to supplier.
Daily and monthly production PPC I/c reviewed through ‘Monthly Production Schedule cum
Production performance Monitoring’ & Production S.H. reviewed through ‘Week wise
Production Schedule Cum Date & Operation wise Production Monitoring’ - monitor the
progress of daily production against the commitment
Mgr. Marketing shall process any amendment in the customers order/change in tech./
Commercial terms for the product, review & amendment to contract and communicate to
respective department.
For regular production item, technical change directly communicate to quality manager and
those change related document change by Quality manager.
If needed then quality incharge send the change related email to CAD engg. And they make
the technical change in drawing and issue to user.
For New development product ,customer change detail directly communicate to development
manager and those related feasibility study carry out by MDT and accordingly amend the
document and issue to respective department.
Vice President shall make plan for Infrastructure/Machinery related modification/change and
take approval from MD. Accordingly modify the plant and machinery.
The product development team identifies, documents and review the manufacturing process
design input requirements, including
o New material
o Development and review of FMEAs, including actions to reduce potential risks, and
o Identifies process control documents including drawings, PFMEA, and control plans
with the customer’s special characteristic symbol or the organization’s equivalent
symbol (CS or CC) or notation to include those process steps that affect special
characteristics.
The Development department shall carry out OR Undertaking design verification ,Design Verification
and action include the measures and method.
Customer Requirement
Functional, Maintenance and safety point of review.
Adequacy to meet expected environment condition
Material Availability
Permission Tolerance and process capability
8.3.4.1 Monitoring
Measurements {quality risks, costs, lead-times, critical paths and others, as appropriate) at
specified stages of design and development are defined, analyzed and reported with
summary results as an input to management review.
When required by the customer, company has a prototype program and control plan. The
company uses, wherever possible, the same suppliers, tooling and manufacturing processes
as well be used in production.
All performance-testing activities are monitored for timely completion and conformance to
requirements.
The company takes the responsibility for the outsourced services, including technical leadership,
when the services are outsourced
The company conforms to a product and process approval procedure recognized by the
customer.
The manufacturing process design output is expressed in terms that can be verified against
manufacturing process design input requirements and validated.
o Control plan
8.3.6 Control of design and development changes/8.3.6.1 Design and development changes –
supplemental.
The Development Manager is authorized to change the process design. The process design changes
may be due to one OR more of Following Reasons:-
1) Production feedback
2) Inspection result
3) Technological improvement OR change
4) Verification feedback
5) Availability of Material
All design changes after initial approval, including those proposed by the organization or its suppliers,
for potential impact on fit ,form, function, performance or durability. These change validate against
customer requirement.
The concerned dept. manager such as production, Q.C. OR Dispatch shall give process design
change as per procedure for control of document. Process design change add in ECN report.
The process design Change shall be properly incorporated at required location such as drawing
changes, change in material, specification. All the connected drawing & control plan shall be
connected in line with the product design change OR Modification.
Company purchases from approved suppliers to ensure that purchased products conforms to
specified requirements.
The Company purchases its products like raw material, Job worked material, bought out
items, packaging material etc. from the Approved suppliers to ensure that purchased product
conforms to specified purchase requirements and applicable regulatory requirements.
Party is assessed and selected based on the above factors in the Supplier self assessment
form. Job Work Supplier select based on auditing and fulfill the requirement of ISO – 9001.
Audit conduct by receive quality control manager.
Other supplier selection criteria that should be considered include the following:
All supplier selection steps not followed for customer approved source unless specific
agreements or defined by the contract between the organization and the customer.
Company purchases products, materials from the approved sources, where contractually
agreed with the customer
8.4.2 Type and extent of control/8.4.2.1 Type and extent of control - supplemental.
After receipt of the purchase item/Job work item receive from the suppliers, they are verified with
respect to the Control plan. Raw Material test report /GRN to ensure that the purchased product
meets specified purchase requirements. Supplier’s delivery and quality performance is evaluated
based on their supplies.
If purchased item is released for further processing prior to verification they are identified so and are
not used till the verification is completed.
Vendor effectiveness monitoring by evaluation as per criteria given in document process of Job work.
Statutory and regulatory requirement like VAT no./Excise law verify during selection of supplier.
No any special control needed for Statutory and regulatory requirement related to product.
Company performs supplier quality management system development with the goal of
supplier conformity with ISO 9001:2015.
Based on the following factors, suppliers are developed (from the approved supplier list).
o Performance of Supplier
Supplier’s quality management system is developed by using any of the following means:
o Sending quality performance ratings and obtaining corrective actions of their process or
systems
o Getting self assessed from the suppliers them selves, based on the company’s quality
management system checklist
o Sending useful training materials to the suppliers for upgrading their knowledge & its
implementation etc.
Rec. QC. Mgr. identifies and communicates the areas for improvement based on the Supplier
Performance.
Rec. QC Mgr. obtains the corrective action plan with target dates of the completion from the
supplier.
If the suppliers are not certified with the ISO 9001, M.D. or Manager Marketing takes the
concession from the customer through the questionnaire of customer specific requirement.
Company ensures that the dealers are authorized by the respective sources.
8.4.2.3.1 Automotive product related software or automotive product with embedded software
Approved suppliers are evaluated on regular basis on following factors and results are
recorded in the Supplier Evaluation form.
o When supply has been stopped for a considerable period of time (more than one year)
Supplier graphical evaluation (Quality and Delivery) is reviewed in the Management Review
meetings and actions arising from the review are recorded.
Company uses quality, quantity, special status, Line stoppage, Warranty and delivery rating
criteria as defined in supplier performance report.
Evaluation criteria:-
Rating is = (B/A)*100
A = Schedule Qty.
B = Receive Qty.
Supplier audit conduct as per supplier audit plan with their supplier management approach, second
party audits may used for the following:
Supplier audit need, criteria scope & frequency decided on basis of product safety/regulatory
requirement, performance of the supplier. and QMS certification level at a minimum.
Active supplier priority, type ,extent and timing of required supplier development actions for its active
suppliers.
Regular supplier audit conduct on following inputs but not limited:
a) Performance issue identify through supplier monitoring
b) Second party audit findings
c) Third party quality management system certification status
d) Risk analysis
Purchasing information shall describes the product to be purchased including the following
appropriates :
P.O. contains purchasing information describing the product to be purchased like the material
specification, dimensional requirements, delivery requirements etc.
P.O. may also contain information related to the requirements for approval of product,
procedures, processes and equipment, requirements for qualification of personnel and quality
management system requirements, if required so.
MD reviews the PO to ensure the adequacy of specified purchase requirements and after
getting approval from MD releases to the supplier.
External provider interactions with Purchase In charge.
All statutory and regulatory requirements are communicate to supplier in PO
Any special product and process characteristics requirement communicate through Drawing
by mentioned symbol.
Suppliers laid down this requirement at point of mfg.
The Company plans and carries out production under controlled conditions.
o Control plans or drawing sheet are accessible to the workstations, which contain all
information that describes the characteristics of the product.
o Work instructions for machine set up for all the employees having responsibilities for
operation of processes that impact product quality, they are made accessible for use
at the workstation. These instructions are derived from the control plan.
o Equipment for the monitoring and measuring is mentioned in the control plan and is
made available for use.
o Production processes are validated by first piece verification and results are noted
down in First Piece Approval & Inprocess Inspection Report.
o Upon the completion of all the operations as mentioned in the control plan they are
released for the final inspection, packing and delivery.
Company plans and develops the processes needed for product realization, whenever new
products are to be developed or when there is a major change in the existing product.
Company ensures that control plan is consistent with the requirements of the other processes
of the quality management system.
o Pre launch & production Control plan that have linkages and incorporates information from
the design risk analysis, process flow & manufacturing process risk analysis outputs.
o Manufacturing Process FMEA is carried out for the entire customer designated special
characteristics.
o Company determines the requirements for the product and is addressed in the Control plan
Control plans are developed for all the parts at various stages starting from receiving to the
final.
Manufacturing process FMEA outputs are taken in to account in the Control Plan.
o List of controls used for the manufacturing process control including verification of job
setups.
o First off/last off part validation as applicable.
o Methods for monitoring of control exercised over special characteristics defined by both
the customer and the company
o Reaction plan, when the process become unstable or not statistically capable/non
conforming product detect.
Customer requirements and references to its Technical specification (Drawings) are included
in the control plans.
Acceptance criteria are defined in the control plans. If required it is sent to the customer for its
approval before the PPAP lot submission. For the attribute data sampling, acceptance level is
taken as zero defects and are mentioned in the control Plans.
Control plans are reviewed and updated when any change occurs effecting product,
manufacturing process, nonconforming product shipped to the customer, measurement,
supply source, production volume change, or FMEA.
Control plan are reviews after customer complaint and implementation of the associated
corrective action,
Company reviews the existing processes and documentation with respect to the specific
requirement of the product and if necessary, it establishes new processes or modifies the
existing processes.
Company also determines and provides new resources requirement like machineries, fixtures,
qualified personnel etc, specific to the product.
Company determines verification, validation, monitoring, inspection and test activities specific
to the product and the criteria for product acceptance and is addressed in the control plan.
Records (like inspection/test records, SPC records, etc.) are maintained to provide evidence
that the realization processes and resulting product meet requirements.
Company also ensures that the output of this planning is in a form suitable for the company’s
methods of operations.
Job setups are verified whenever a setup is performed (e.g. initial run of a job, material
changeover, job change, significant time periods lapsed between runs, etc) and are recorded
in First Piece Approval & In process Inspection report. Job instructions are available for setup
personnel as applicable. Company uses statistical methods of verification for all the special
characteristics as identified in the control plans.
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and
equipment.
A system for tooling management is established and implemented as per the following:
o Setup
o Tool Identification, such as serial or asset number the status, tool production, repair
or disposal by production In charge.
The company provides necessary technical resources for tool and gauge design, fabrication
and full dimensional inspection, if any of this work is subcontracted. Company also ensures to
track and follow-up on these activities as per the activity chart.
At present we are not use customer owned tools, manufacturing equipment and test
/inspection equipment.
o Upon the receipt of the customer order, (written), Manager Marketing reviews the
requirements related to the product, including the product specifications, timing and
quantity requirement, packaging, transportation requirement etc and Manager - Marketing
shall acknowledgment the order by email same shall be add in customer order
monitoring sheet.
o Mgr. Marketing resolves with the customer if any of the contract or order requirements are
differing from those previously expressed.
o Asst. Manager Marketing receives schedule from customer (OEM) for regular order &
review the same for delivery with Managing Director, Technical Director and Executive
Director, if required.
o Status of the pending order shall be monitored through Computer system. Asst. Manager
Marketing shall inform to customer change in schedule if delay.
o Order Amendments: Mgr. Marketing shall process any amendment in the customers
order after any change in tech./ Commercial terms for the product, review & amendment
to contract and request to customer for P.O. Amendment (if applicable).Customer revised
P.O. received and P.O. accepted status inform to customer by email. Revised order detail
communicate to PPC.
Mgr. Marketing contacts the customer, if any of the requirements are not clearly defined or
understood.
Records of the results of the review and actions arising from the review (Team feasibility form,
customer communication on schedule matters, Management review) are maintained.
If customer given any authorized waiver for the requirements stated shall be keep as
document information for review.
Manager Marketing prepared the Daily Dispatch Advise Form and gives to dispatch incharge.
Asst. Manager Marketing monitors the actual dispatches with the committed in the Daily
Delivery Performance Monitoring – Product Wise.
Asst. Manager Marketing presents the Customer & Product wise delivery performance report
in Management review meetings.
Production planning
Manager Marketing shall prepared tentative production plan on the basis of customer
schedule, pending order and order received from OEM in consultation with M.D. and G.M.
(Operation).
On the basis of tentative production plan and availability of the material, PPC I/c & Production
I/c. shall prepared production plan on monthly basis.
Make monthly production plan of components before the starting of month in 'Monthly
Production Schedule Cum Production Performance Monitoring.'
Daily production status review against plan in daily meeting and take appropriate action and
priority as per instruction from Vice President.
Based on orders and stock, component planning is carried out than release P.O. to supplier.
Daily and monthly production PPC I/c reviewed through ‘Monthly Production Schedule cum
Production performance Monitoring’ & Production S.H. reviewed through ‘Week wise
Production Schedule Cum Date & Operation wise Production Monitoring’ - monitor the
progress of daily production against the commitment
Company utilizes Identification Tag for effective component identification and trace ability.
The responsibility for identification of the product by suitable means throughout product
realization is as per the defined below.
1. Stores: Material received and pending for inspection shall be kept in identified area mentioning
“Pending for Inspection”. Rejected Material shall be kept in Rejected Area. All other material
available in the stores shall be treated as “Conforming Material” and at all the stages, material
shall be identified with Tags / No. mentioned on racks.
2. Raw Material Store (Green Tag): Con Rod available in the Raw Material Stores shall be
identified by Green Tag. With details of Part Description, Op. Completed, Supplier, Ch. No. & Dt.,
Qty., Sign. and Date.
3. Product Identification at Inprocess Stage:
1. The semi-finished product shall be kept in identified area bins with details of Item No.,
Operation completed and test status. Inprocess Identification as below
The Company identifies the product status with respect to monitoring and measurement
Requirements. Tags or color provided by customer on the product which indicates
the following Information
All the products which are to be rejected are identified so and kept in separate location. All the
products which can be corrected are identified so and kept in separate location.
Company has the following coding system for traceability for components since traceability is
a specific requirement,
Part Traceability System:
e.g. xxxx/A/9/AI
Customer drawings or sample are protected it from lost or damages. Manager Marketing
reports the customer representative if the drawings are lost, damaged or unsuitable for use.
Company does not possess any customer – owned production tooling; hence the standard
requirement on customer – owned production tooling is not applicable.
Company has established a system to preserve the conformity of product during all the
stages of production. Established system mentioned below includes identification, handling,
packaging, storage and protection of the product
Company preserves the conformity of product during internal processing and delivery to the
intended destination.
Handling:
Stores Incharge, Section head and Asst. Manager Quality shall ensures that material /
product is carefully handled at all stages of production to prevent damage or deterioration of
the material / product. Where required specific instructions for handling / transportation shall
be given which provides appropriate precautions to be taken for this activity.General part
specific trolly use for part handling.
Packaging:
Packaging for manufactured products is designed in consultation with customer, to the extent
necessary to ensure conformance to specified requirements. Production Manager and
marketing manager shall ensure that packing of final product is carried out as per schedule.
Raw material is stored at designated storage area and details of stock are noted down in
stock register,
Inventory turns over time (Sales value/Inventory value) are monitored at every month &
review Every Six Month and also in the management review meeting. Stock rotation (lying in
various areas) is ensured by following the Stock Register.
Consumable material stock and issue – receipt details are noted down in Stock register.
Presently post delivery activities are not a requirement, hence not addressed.
Company not binding or not contract with customer for warranty provisions, contractual
obligation such as maintenance services, and supplementary services such as recycling or
final disposal.
Since no customer requirement of after service, the requirements on these clauses are not defined &
documented. However, on requirement from the customer, system shall be defined
Company has a process to control and react to changes that impact product realization. For
any process changes (including during new product introduction) occur due to following
situations PPAP is initiated through ENGINEERING CHANGE TRACKING FORM.
o Change in supplier for parts that affect fit, form, and function (including performance and /
or durability).
The results (from the inspection/test records, SPC records etc.) after the process changes are
verified and validated to see whether the product meet customer specific requirements or not.
These results are communicated to the customer if required by the customer through Part
submission warrant (PSW).
Prepared 4M change sheet which include all the alternate method use for change. Alternate method
decided on basis of risk analysis or PFMEA.
Before shipping product that was inspected or tested using the alternate methods, if required, the
organization shall obtain approval from the customer. The organization shall maintain and periodically
review a list of approved alternate process control methods that are referenced in the control plan.
Standard work instructions available for each alternate process control method. The organization
review the operation of alternate process control on a daily basis, at a minimum, to verify
implementation of standard work with the goal to return to the standard process as defined by the
control plan as soon as possible.
Maintained traceability of all product produced while any alternate process control devices or
processes are being used. (e.g. verification and retention of first piece and last piece from every shift)
During the In-process & final stage, products are inspected as per the frequency defined in
the Control plan and recorded in the First Piece Approval Cum Inprocess Inspection report
(Process wise) and Final inspection report respectively.
Inspection reports are indicated with the person(s) authorizing release of product.
In case, if the planned inspection arrangements are not completed at any of the production
stages, they are not released to the customer, unless they give the approval.
Various parts of Con Rods are inspected and results are noted down in First Piece Approval
Cum In process Inspection report (Process wise) for in process stage and Final inspection
reports for final stage.
Quality Manager ensures that a layout inspection is carried out for all the parts as per Layout
inspection plan and recorded in the Layout Inspection report.
Quality Manager ensures that the results of the Layout inspection is made available for the
customer review, if require by them.
No products have been designated as ‘Appearance items’ by any of the customers. Hence
the requirements on appearance items are not defined & documented. However, on
requirement from the customer, system shall be defined.
Upon the receipt of the materials from the suppliers, they are verified as per the control plan/
Specification chart for each raw material and results are recorded in Receiving Inspection
Report and Material Test Report.
Frequency of receiving inspection and control method, which are addressed in control plans
are decided based on the following
Those lots which have been given concession to the supplier are identified with the
Identification tag.
Release of externally provided products into its production flow , the company confirm and
able to keep evidence that externally provided processes, product and services conform to
the latest applicable statutory, regulatory or other requirements in the countries.
Where the Company or its customer intends to perform verification at the supplier’s premises,
the Company states the intended verification arrangements and method of product release in
the Purchase order.
Acceptance criteria are defined in the control plans. If required it is sent to the customer for its
approval before the PPAP lot submission. For the attribute data sampling, acceptance level is taken
as zero defects and are mentioned in the control Plans.
Description:
Quality Manager ensures that Non-conforming products (including the product with
unidentified or suspect status) found at any stage (i.e. receiving, in-process and final) are
identified as non-conforming product and are kept at separate location to prevent its
unintended use.
After maintaining the record of the non-conformity, QA Manager shall dispose of the
Non-conforming Material.
Quality Manager reviews the non-conforming products and initiates any of the following
actions, but not limited to,
o Rework the nonconforming product to meet specified requirements
Reject the nonconforming product QA Incharge shall take the decision to dispose the
Nonconforming material:
Based on above points, Quality Incharge shall take corrective and / or preventive actions.
QA Incharge shall review the non-conformity analysis, once in a month and take corrective
and / or preventive action in area where major problem observed.
Re-verification is done as per the control plan for the products, which have been corrected.
In case, if it is found that any nonconforming products are found to have already delivered to the
customer, Quality Manager takes any of following actions based on the effects or potential effects
of the nonconformity.
Production Section Head & Quality Manager analyses the nonconforming products and
summarize it in the N. C. Register and make the graphical presentation in the management
review meeting.
Training provide to Inspector regarding non conforming and suspected product.
If any customer specific control for non conforming product that step follow.
All reworked product at any stage shall be re-inspected as per respective control plan
and Drawing and record after rework re verification maintained with traceability.
Risk analysis include in rework process decision.
At present company will not include in repaired product activity with customer.
Incase, the product deviates from the currently approved product, prior customer authorization is
obtained & details including the expiration date or quantity authorized & the identification mark are
note down in the Engineering approval product authorize.
If, any verbal approval given by customer regarding above matter then note down the customer
authorized person name and time of tele talk & other details in the Engineering approval product
authorization form.
Material stripped on any authorization is identified on each package and a copy of Engineering
approval product authorization form is sent along with the dispatch.
In case, if it is found that any nonconforming products are found to have already delivered to the
customer, Quality Manager takes any of following actions based on the effects or potential effects
of the nonconformity.
Reference Document :
Procedure for request for change : VHV/P/8/01
Procedure for customer order : VHV/P/8/02
Procedure for Supplier selecton evaluation : VHV/P/8/03
Procedure for store : VHV/P/8/04
Procudure for tooling management : VHV/P/8/05
Procedure for production planning : VHV/P/8/06
Procedure for Inspection : VHV/P/8/07
Procedure for Preventive and breakdown maint : VHV/P/8/08
Procedure for ECN : VHV/P/8/09
Procedure for development of new product : VHV/P/8/10
Procedure for PPAP : VHV/P/8/11
Procedure for supplier development : VHV/P/8/12
Purpose :-
The purpose is to plan and implement the monitoring measurement, analysis and improvement
processes needed to demonstrate the conformity of the product, to ensure conformity of the quality
management system and to continually improve the effectiveness of the quality management system.
Production Manager : - For the performance evaluation of the product and process.
Description:-
The company monitors and measures the quality management system processes in the
internal quality audits. In the Internal quality audits, it is verified that the planned results of the
quality management system processes are achieved.
When planned results are not achieved, correction and corrective action is taken, as
appropriate, to ensure conformity of the product.
Studies all the new manufacturing processes (like during new product development) to verify
process capability & to provide additional input for process control.
Production manager ensures that the Control plan and process flow charts are implemented,
including adherence to the specified.
On occurrence of change in any processes, relevant documents (like flow process chart,
Control / Quality plans etc) are changed to know the effective dates of process changes.
Company ensures that planning of product & service is consistent with the requirements of
the other processes of the quality management system.
The company monitors and measures the quality management system processes in the
internal quality audits. It is verified that the planned results of the quality management system
processes are achieved.
When planned results are not achieved, correction and corrective action is taken, as
appropriate, to ensure conformity of the product.
CFT studies all the new manufacturing processes (like during new product development) to
verify process capability & to provide additional input for process control.
Prepared by . Approved by .
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VHV PRECISION ENGINEERING
Quality Manual Performance Evaluation
Ref.: ISO 9001:2015, clause 9 Section: VHV/QM/9 Rev. No. / Date : 00 / 01.06.2022
Production Manager ensures that the Quality (control) plan and process flow charts are
implemented, including adherence to the specified.
o Measurement techniques
o Sampling plan
o Acceptance criteria
o Records of actual measurement value and test result for variable data.
o Acceptance criteria, and
o Reaction plans when acceptance criteria are not met
Control charts (X & R chart) are used for the special characteristics as identified in the Control
plan(s). Where the customer requires for a certain level of capability of any processes (like Cp
>=1.33 / Cpk >= 1.67 etc), they are maintained. Process capability is measured for such
product characteristics in the Process capability study sheet.
Significant process events, such as tool change or machine repair, shall be recorded in X-R
chart.
Production Manager initiates a reaction plan ( 100 % inspection) from control plan for
characteristics that are found either not statistically capable or unstable from the Process
capability study / X &R Chart (Control chart).
In such cases, Production Supervisor & Quality Inspector Ensures 100% inspection or
containment of product as appropriately.
Production manager And Quality Manager takes appropriate actions to ensure that the
process becomes stable and capable.
On occurrence of change in any processes, relevant documents (like flow process chart,
Control plans etc) are changed to know the effective dates of process changes.
Cross function team determines appropriate statistical tools including process stability &
capability studies, measurement system analysis etc during advance quality planning and
includes it in the control plan.
During the process of taking of corrective action, following statistical tools may be used
o Brainstorming
o Pareto analysis
o Histograms
o Mistake Proofing
Basic statistical concepts, such as variation, control (stability), process capability and over-
adjustment are understood and utilized throughout the organization as applicable and
employee are involved in the collection, analysis and management of statistical data.
Prepared by . Approved by .
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VHV PRECISION ENGINEERING
Quality Manual Performance Evaluation
Ref.: ISO 9001:2015, clause 9 Section: VHV/QM/9 Rev. No. / Date : 00 / 01.06.2022
o Customer disruptions
M.D. compares the customer satisfaction survey results received from the customer with that of
the objective data available in the company.
Apart from the survey, company also takes into consideration the following aspects to know
the satisfaction level of its customers
o Customer complaints (No. of customer complaints, Nature & severity of the customer
complaints, Repetitive complaints etc, Product returns)
Customer satisfaction study results (in the graphical manner, as appropriately) are analyzed
in the Management review meetings, which is an indication of the performance of the quality
management system
To demonstrate the suitability and effectiveness of the quality management system following
are analyzed in the Management Review meetings as per the frequency depending on the
events.
o Results of the customer satisfaction surveys
o Customer ratings
Prepared by . Approved by .
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VHV PRECISION ENGINEERING
Quality Manual Performance Evaluation
Ref.: ISO 9001:2015, clause 9 Section: VHV/QM/9 Rev. No. / Date : 00 / 01.06.2022
o Results of the Internal audits (no. of non conformities and the severity of the
nonconformities)
In the Management review meetings, trends in quality and operational performance (like
rejection%, cost of poor quality, no. of customer complaints, delivery performance, inventory
turnover ratio, m/c breakdown% etc) are compared with progress toward objectives and lead
to support the following
o Information system for the timely reporting of product information arising from usage
In the graphical trends, objectives are shown with thicker dotted lines for the easy comparison
of the progress.
9.2 Internal audit / 9.2.2.1 Internal audit programme /9.2.2.2 Quality management system audit /
9.2.2.3 manufacturing process audit .
Procedure description:
Company selects the auditors based on the training given to them on ISO 9001:2015 , Internal
Audit Training and list of qualified auditors is made. Scope of the auditors in the internal audits is
defined in it, considering that the auditors do not audit their own work.
Management representative prepares Yearly Internal audit plan for ISO 9001:2015 to conduct
internal audits of all the functions once in Six months.
Apart from the quality management system, internal audits cover following points also, as
applicable
Management representative releases the Internal Audit Schedule For ISO 9001:2015 to the
Auditors and the Audit representatives to ensure that the auditors as well as the auditees are
aware of the plan/schedule date.
Auditors communicate the time of the audit to the respective auditees before commencement of
the audits.
Auditor audits the function to be audited (Auditee) as per the Plan. Quality management system
documents like Quality manuals, Procedures, Processes, Control plans, Work instructions are
used as audit checklist. Specific checklists (Mfg. process audit check list.) may also be used if
required for the Auditors.
Auditors issue Nonconformity cum corrective action reports to the auditee for all the
nonconformities observed during the audit.
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VHV PRECISION ENGINEERING
Quality Manual Performance Evaluation
Ref.: ISO 9001:2015, clause 9 Section: VHV/QM/9 Rev. No. / Date : 00 / 01.06.2022
Auditee takes the disposal action / corrective action (as appropriate) to eliminate the non-
conformity identified during the audit and submits the completed Nonconformity cum corrective
action reports to the Auditor.
Auditor verifies the corrective action / disposal action taken in the follow-up audit.
Auditor verifies the effectiveness of the corrective action taken during the follow-up audits and he
notes down his comments in the Nonconformity cum corrective action reports.
Auditors submit the Nonconformity cum corrective action reports to Management Representative,
after closing the nonconformities.
Auditor reports to Management Representative, if actions are not found completed during Follow-
up audit.
MR may in-turn rearrange the Follow-up audit to ensure that the actions are taken without undue
delay to eliminate detected nonconformities and their causes. Auditors also see during the audit
whether any of the NCs of the previous audits are pending with the Auditee.
Management Representative evaluates the audit results and prepares Summary of non-
conformity based on IQA for the management review.
If more nonconformity is received in any of the areas, MR updates audit plan, by increasing the
frequency of the audits in that particular area.
Note: For the easy understanding of the internal audit procedure, refer Quality System Procedure
Internal audit.
Product audits are conducted at various stages (After completion of all processes) to verify
conformance to all specified requirements, such as product dimensions, functionality,
packaging and labeling. Product Audit conducted as per Mfg. process cum product check
sheet.
9.3.1/9.3.1.1 General
Management reviews the organization’s Quality Management System after every 6 months to
ensure its continuing suitability, adequacy and effectiveness.
This review includes assessing opportunities for improvement and the need for changes to
the Quality Management System including Quality policy and Quality objectives.
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VHV PRECISION ENGINEERING
Quality Manual Performance Evaluation
Ref.: ISO 9001:2015, clause 9 Section: VHV/QM/9 Rev. No. / Date : 00 / 01.06.2022
The output form the management review includes any decision and actions related to:
1 Improvement of the effectiveness of the Quality Management System and its processes
2 Improvement of product related to customer requirements, and
3 Resources needs
Minutes of meeting shall circulated to all functional heads and get the target date of completions of
actions decided in management review.
Customer performance target not met then top management shall make & implement action plan.
Reference Document :
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VHV PRECISION ENGINEERING
Quality Manual Improvement
Ref.: ISO 9001:2015, clause 10 Section: VHV/QM/10 Rev. No. / Date : 00 / 01.06.2022
Purpose :-
The purpose is to plan and implement the monitoring measurement, analysis and improvement
processes needed to demonstrate the conformity of the product, to ensure conformity of the quality
management system and to continually improve the effectiveness of the quality management system.
Quality Manager : Responsible for customer complaint and field failure including any returned parts
and shall initiate problem solving and corrective action /Warranty failure /no trouble found.
Description:-
10.0 Improvement
10.1 General
Company has determined the opportunities for improvement and implement necessary actions to
meet customer requirements.
Improvement can include correction, corrective action, continual improvement, breakthrough change,
innovation & re-organization.
10.2.1/10.2.2
Non-conforming products found at any stage (i.e. receiving, in-process and final) are identified
as non-conforming product and are kept at separate location to prevent its unintended use.
Details including reason of non-conformity are recorded in the Batch card or production report
as per the documented procedure for Control of Non-conforming product.
In-charge Production review the non-conforming products and initiates any of the following
actions, but not limited to:
Actions taken are also noted down in the Batch card or production report as per the
documented procedure for control of Non-conforming products.
Re-verification is done as per the drawing/control plan for the products, which have been
corrected.
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VHV PRECISION ENGINEERING
Quality Manual Improvement
Ref.: ISO 9001:2015, clause 10 Section: VHV/QM/10 Rev. No. / Date : 00 / 01.06.2022
In case, if it is found that any non-conforming products are found to have already delivered to
the customer, In-charge production takes any of following actions based on the effects of
potential effects of the non-conformity.
Informs the In-charge marketing to inform the customer regarding the detected nonconformity.
Informs the in-charge marketing to offer replacement to the customer (It is functionally
affected).
In-charge production analyses the non-conforming products and summarize it and make the
graphical presentation in the management review meeting (If non-conformity is more).
Company has a documented procedure for taking action to eliminate the cause of non
conformities in order to prevent recurrence. Corrective actions are taken considering the
effects of the non-conformities encountered.
Concern function reviews the non-conformities in the following areas, but not limited to,
Customer complaints
Internal rejection
Any failure which has resulted in the customer dissatisfaction based on the Customer
satisfaction cum expectation survey
Based on the effects of the non-conformities, corrective actions are initiated in the form of
8D report as per the documented procedure for Corrective action by various functional heads to the
person responsible for corrective actions.
Person who is responsible for the corrective action determines the root cause of the non
conformities and noted down in the Corrective actions report as per the documented
procedure.
Person who is responsible for the non-conformity evaluates the need for action to ensure that
the non-conformity does not occur.
Concern function determines the action needed and are recorded in the corrective action
report as per the documented procedure.
Concern function ensures that the actions identified in the Corrective action report are
implemented.
M.R. reviews the results of the action taken in the Management Review Meeting and are
recorded in the Corrective action report as per the documented procedure.
Company has defined process for problem solving leading to root cause identification and
elimination in the following situations
o Customer complaints
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VHV PRECISION ENGINEERING
Quality Manual Improvement
Ref.: ISO 9001:2015, clause 10 Section: VHV/QM/10 Rev. No. / Date : 00 / 01.06.2022
o Rejections etc
Company uses following problem solving methods in the corrective actions (Corrective action
report), as appropriately
o Brainstorming
o Pareto analysis
o Histograms
o Mistake proofing
o Poka Yoke
o 8D Methodology
10.2.4 Error-proofing
Company uses error-proofing methods in their corrective action process actions (Corrective action
report) to a degree appropriate to the magnitude of the problems and commensurate with the risks
encountered
Details of the method used shall be documented in the process risk – PFMEA and test frequencies
recorded in control plan.
Error proofing device test for failure and result recorded in Preventive maintenance report
Challenge parts of error proof device identified ,controlled, verified and calibrated where feasible
.Error proofing failure reaction plan defined in control plan.
At time of product development. standard term and condition sign. with customer for warranty failure.
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VHV PRECISION ENGINEERING
Quality Manual Improvement
Ref.: ISO 9001:2015, clause 10 Section: VHV/QM/10 Rev. No. / Date : 00 / 01.06.2022
Enter the complaint details OR Field failure OR Returned parts detail in the Customer Complaint
Monitoring Register.
Analyze the root cause of the complaint, and take necessary corrective actions by using disciplined
problem solving methods (5Why,Ishikawa) & error proofing (as appropriately) in the Corrective action
plan analysis OR 8D Report.
If any customer need to specific time line for containment action ,root cause and corrective closer
same shall follow by Quality manager. Complaint closer time line mentioned in CSR matrix.
Apply the corrective action to eliminate the cause of nonconformity and note down the details in 8D
Report. Action communicate to the customer
Company has established systematic approach for continually improve the quality
management system through the use of quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions and management review etc.
Progress of quality objectives are monitored and reviewed in every management review
meeting and may be revised if necessary.
Audit results are analyzed for the No. of non-conformities received in various functions and
the severity of the non-conformities received during the internal quality audits.
Corrective actions may be taken by reviewing the existing systems and training may be
identified and given to the concern personnel.
Manufacturing process improvement action plan with emphasis on the reduction of process variation
and Risk analysis.
Reference Document :
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