Example of IATF 16949:2016 Quality Manual

Pretesh Biswas Uncategorized July 5, 2023July 5, 2023 93 Minutes

1.0 Introduction

We are a customer centric organization, and our high quality standards and emphasis on excellence, allows us to take pride in our work at every step of every production process. We are a team of talented people practicing continuous improvements as a way of working in our organization, willing to go the extra mile for achieving and delivering results. The diverse needs of our valued customers, both domestic and overseas, are carefully addressed by our commitment to the following:

Quality : Continuous Improvement to meet and exceed customer expectations

Cost: Competitiveness with value added products

Delivery: Deliver products at right time.

By adhering to the quality standards, our mission is to be a leading company in our field of activity, service & excellence, through total customer satisfaction and thereby developing a nationwide market of our present and future products.

1.1 Infrastructure Available

Design : Auto CAD & 3D Modeling, Solid Edge
Manufacturing:
- Press Shop: Presses ranging from 2T-400T (Mechanical, Hydraulic and Hydro Pneumatic)
- Tool Room: Lathe, Milling Machines, Radial Drilling, Cylindrical Grinders, Surface Grinders
- Machine Shop: Special Purpose Blank Turning, Multi Spindle Drilling, Hobbing, Thread Rolling, Centre Less Grinder, Deburring, Window Grinding, Automats, Riveting, Tube Cutting & Chamfering, Tapping, Induction Hardening & Tempering.
Welding and CNC Equipment: CNC Turning Machine, CNC Tube Bending, Robotic MIG welders, MIG/TIG welding, Projection welding and Spot welding.
Testing & Quality: Measuring & Testing Equipment Such as Profile Projector, Hardness Tester, Salt Spray Chamber, Spring Load Testing, Plating Thickness Tester, Height Gauges, Micrometers, Calipers. Digital Micro Hardness Tester , Micro Scope for Cut Etching Testing, Crack Detector Machine
AT EMS:- Hardness tester, Plating Thickness tester, Height Gauges, Micrometers, Calipers.

2.0 References and Standards

The List of References which include Standards, Manuals, Processes and applicable product Regulatory Requirements used in developing and implementing the systems is given below:

Our Quality Management System makes reference to the following standards

a)	ISO 9000:2015:	QMS Fundamental and Vocabulary
b)	ISO 9001:2015	:QMS Requirements
c)	ISO 9004:2009	:QMS guidelines for performance improvement
d)	IATF 16949:2016	: Quality management system requirements for automotive production and relevant service parts organizations
e)	ISO190011:2011	Guidelines for quality and/or Environmental management System Audit
f)	ISO / IEC 17025	General requirement for the competence of testing & calibration laboratories

3.0 Terms, Definition & Abbreviations

In this Quality System Manual and related procedures / instructions, following terms / definitions and abbreviations have been used

Interested Parties:Person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity
Risk: Effect of uncertainty
Competency: Ability to apply knowledge and skill to achieve intended results
Documented Information:Information required to be controlled and maintained by the an Organization and the medium on which it is contained
Requirement :Need or expectation that is stated, generally implied or obligatory
Management System: Set of interrelated or interacting elements of an organization to establish policies and objectives and process to achieve those objectives
Top Management: Person of group of people who direct and control an organization at the height level
Effectiveness: Extent to which planned activities are realized and planned results achieved
Policy: Intentions and direction of an organization, as formally expressed by its top management
Objective: Result to be achieved
Process: Set of interrelated or interacting activities, which transfer input into output.
Outsource: Make an arrangement where an external organization performs part of an organization’s function or process
Monitoring : determining the status of a system, a process or an activity
Measurement : process or determine a value.
Audit : Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled
Conformity : Fulfillment of a requirement
Non-conformity : Non fulfillment of a requirement
APQP : Support development of a product/service that will satisfy customer requirements
After Market :Not procured or released by an OEM for service parts application
Challenge (Master) parts : Use to validate the functionality of the error-proofing device or check fixtures
Design for assembly (DFA) Process by which product are designed with ease of assembly consideration
Design for manufacturing (DFM): Integration of product design & process planning to design a product that is easily & economically manufactured
Design for six sigma (DFSS): Systematic methodology, tools & technique with the aim of being a robust design of product or process that meets customer expectations & can be produced at six-sigma quality level
Design for manufacturingand assembly (DFMA) : combination of two methodologies: Design for Manufacture (DFM), which is the process of optimizing the design to be easier to produce, have higher throughput, and improved quality; and Design for Assembly (DFA), which is the optimization of the design to reduce risk of error, lowering costs, and making it easier to assemble design for six sigma (DFSS) systematic methodology, tools, and techniques with the aim of being a robust design of products or processes that meets customer expectations and can be produced at a six sigma quality level
Escalation process: Process used to highlight or flag certain issues with an organization so that the appropriate personnel can respond to these situations and monitor resolutions
Fault tree analysis (FTA) Maps the relationship between faults, subsystem and redundant design elements by creating a logic diagram of the overall system
No trouble found (NTF): Parts replace during a service events that, when analyzed, Meets all the requirements of good parts
Preventive maintenance :Planned activities at regular intervals (time-based, periodic inspection, and overhaul) to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design.
Periodic overhaul :To prevent a major unplanned breakdown where, based on faults or interruption history, a piece of equipment, or subsystem of the equipment, is proactively taken out of service
Predictive maintenance: Set of technique to evaluate the condition of in service equipment by performing periodic or continuous monitoring of equipment conditions, in order to predict when maintenance should be performed
Product safety: Standard relating to the design & manufacturing of product to ensure they do not represent harm or hazards to customer
Production shutdown: Manufacturing processes are idle; item span may be few hours to few months
Total productive :Maintaining& improving the integrity of the production and quality
Maintenance : system through machines, equipment, processes and employee that add value to the organization
Trade off curves : Tool to understand and communicates the relationship of various design characteristics of a product to each other
Trade off processes :Methodology of developing & using trade off curves
Premium freight : Extra costs or charges incurred additional to contracted delivery (This can be caused by method, quantity, unscheduled or late deliveries, etc)
Remote location :Location that supports sites and at which noon-production processes occur
Special characteristic :Product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product
Verification: Conformation through the provision of objective evidence, that specified requirement have been fulfilled.
Validation :Conformation through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
Corrective action : action to eliminate the cause of nonconformity and to prevent re-occurrence.
Continual Improvement: recurring activity to enhance performance
accessory part: customer-specified additional component(s) that are either mechanically or electronically connected to the vehicle or power train before (or after) delivery to the final customer (e.g., custom floor mats, truck bed liners, wheel covers, sound system enhancements, sunroofs, spoilers, super-chargers, etc.)
Advanced product quality: Product quality planning process that supports development of a planning (APQP) product or service that will satisfy customer requirements; APQP serves as a guide in the development process and also a standard way to share results between organizations and their customers; APQP covers design robustness, design testing and specification compliance, production process design, quality inspection standards, process capability, production capacity, product packaging, product testing and operator training plan among other items
Aftermarket part :Replacement part(s) not procured or released by an OEM for service part applications, which may or may not be produced to original equipment specifications
Authorization :documented permission for a person(s) specifying rights and responsibilities relate to giving or denying permissions or sanctions within an organization
challenge (master) part : part(s) of known specification, calibrated and traceable to standards, with expected results (pass or fail) that are used to validate the functionality of an error-proofing device or check fixtures (e.g., go / no-go gauging)
Control plan : Documented description of the systems and processes required for controlling the manufacturing of product
Customer requirements: All requirements specified by the customer (e.g., technical, commercial, product and manufacturing process-related requirements, general terms and conditions, customer specific requirements, etc.). Where the audited organization is a vehicle manufacturer, vehicle manufacturer subsidiary, or joint venture with a vehicle manufacturer, the relevant customer is specified by the vehicle manufacturer, their subsidiaries, or joint ventures.
customer-specific requirements (CSRs): Interpretations of or supplemental requirements linked to a specific clause(s) of this Automotive QMS Standard.
Design-responsible organization: Organization with authority to establish a new, or change an existing product speciﬁcation. NOTE : This responsibility includes testing and veriﬁcation of design’s performance within the customer’s speciﬁed application.
Error prooﬁng :product and manufacturing process design and development to prevent manufacture of nonconforming products
Escalation process : Process used to highlight or ﬂag certain issues within an organization that the appropriate personnel can respond to these situations and monitor the resolutions
Laboratory : Facility for inspection, test, or calibration that may include but is not / limited to the following: chemical, metallurgical, dimensional, physic electrical, or reliability testing
Laboratory scope :Controlled document containing speciﬁc tests, evaluations, and calibrations that a laboratory qualified to perform; a list of the equipment that the laboratory uses to perform the above; And list of methods and standards to which the laboratory performs the above
Manufacturing : Process of making or fabricating production materials; production parts or service parts; assemblies; or heat treating, welding, painting, plating, or other ﬁnishing services.
Manufacturing feasibility : An analysis and evaluation of a proposed project to determine if it is technically feasible to manufacture the product to meet customer requirements. This includes but is not limited to the following (as applicable): within the estimated costs, and if the necessary resources, facilities, tooling, capacity, software, and personnel with required skills, including support functions, are or are planned to be available
Manufacturing services : companies that test, manufacture, distribute, and provide repair services for components and assemblies
Multi-disciplinary approach : Method to capture input from all interested parties who may inﬂuence how a process is administered by a team whose members include personnel from the organization and may include customer and supplier representatives; team members may be internal or external to the organization; either existing teams or ad hoc teams may be used as circumstances warrant; input to the team may include both organization and customer inputs
Outsourced process : Portion of an organization’s function (or processes) that is performed by an external organization
Product :Applies to any intended output resulting from the product realization process.
Reaction plan : Action or series of steps prescribed in a control plan in the event abnormal or nonconforming events are detected
Service part :Replacement part(s) manufactured to OEM specifications that are procured or released by the OEM for service part applications, including remanufactured parts site
Site : Location at which value-added manufacturing processes occur
Special status :Notification of a customer-identified classification assigned to an organization where one or more customer requirements are not being satisfied due to a significant quality or delivery issue
Support function : Non-production activity (conducted on site or at a remote location) that supports one (or more) manufacturing sites of the same organization
Embedded software : Embedded software is a specialized programme stored in an automotive component (typically computer chip or other non- volatile memory storage) specified by the customer, or as part of the system design, to control its function(s). To be relevant in the scope of IATF 16949 certification, the part that is controlled by embedded software must be developed for an automotive application (i.e., passenger cars, light commercial vehicles, heavy trucks, buses, and motorcycles; ). NOTE: Software to control any aspect of the manufacturing process (e.g., machine to manufacture a component or material) is not included in the definition of embedded software.

4 Context of the organization

4.1 Understanding the organization and its context

XXX conducts SWOT Analysis for identification of internal & external issues for every process; these issues are considered while caring out the risk analysis. Action plan is prepared for mitigating the risk & also for improvement considering the strength & opportunities. Issues & Requirements monitoring sheet- Annexure- 05

4.2 Understanding the needs and expectations of interested parties

XXX has identified relevant interested parties having effect or potential effect on the organization’s ability to supply products & services that meet customer & applicable statutory and regulatory requirements. Needs & expectation of these interested parties are considered while doing risk and opportunity analysis & while establishing quality management system

Issues & Requirements monitoring sheet- Annexure- 05

4.3 Determining the scope of the quality management system

XXX has considered the internal & external issues, need & expectations of relevant interested parties while establishing the Quality Management Systems.

4.3.1 Supplemental

Permitted exclusions with justification for XXX defined in scope

Scope Manufacture of Tubular, Sheet Metal and Machined Components and Sub Assemblies

Manufacturing Machining, Sheet Metal Press shop, Pipe binding, Induction

Processes hardening, Welding, Assemblies , Shot Blasting and plasma Cutting.

Manufacturing CNC Turning, Hobbing, Drilling, Sheet Metal Press shop,

Processes Induction hardening, Assembly, Broaching, Tapping.

Products- Rear Sprocket, Drum sprocket assembly, Shafts and shafts assembly, Sheet Metal components and Engine Sprockets.

Remote location Nil

Exclusion 8.3.3.1,8.3.2.3, 8.3.5.1- Product design & development

Justification Products are manufactured as per customer drawings

Unit: XXXXXX

4.3.2 Customer-specific requirements

CSR Matrix-Annexure-8

4.4 Quality management system and its processes

4.4.1 XXX has established, documented, implemented and is maintaining the QMS and improving its effectiveness continually in accordance with the requirements of IATF16949:2016

S.No.	Process	Requirements
1.	Top Management (Policy making, Business planning, Continual improvement, Management review)	4.1, 4.2, 5.1.1, 5.1.2, 5.2.1, 5.2.2, 5.3, 9.3.1, 9.3.2, 9.3.3
2	Marketing	4.1, 4.2, 4.4.1, 4.4.2, 6.1, 6.2, 7.1.6,
2	(Contract review, Customer feed back/ satisfaction assessment, enquiry handling, Schedule planning, production & dispatch)	7.2, 7.3, 7.5.3, 8.2.1, 8.2.2, 8.2.3, 8.2.4, 8.5.3, 8.5.5, 9.1.2, 9.1.3, 10.2
3	Purchase (Supplier selection, Supplier Evaluation and monitoring, Procurement of material, Supplier audit, Supplier system development, control over outsourced process)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2, 7.3, 7.5.3, 8.4.1, 8.4.2, 8.4.3, 8.5.2, 8.5.3, 8.5.4, 8.7, 9.1.3, 10.2
4	Production (Machining, Sheet Metal, Pipe binding, Welding, Induction Hardening)	4.1, 4.2, 6.1, 6.2, 7.1.2, 7.1.3, 7.1.4, 7.1.5, 7.1.6, 7.2, 7.3, 7.5.3, 8.1, 8.5.1, 8.5.2, 8.5.3, 8.5.4, 8.5.5, 8.5.6, 8.7,
5	Quality& Lab (Control of monitoring & measuring resources, MSA, SPC, Incoming, In-process, Final, Layout/Dock inspection, Control over NC products, Customer complaints, Analysis & Corrective action)	4.1, 4.2, 6.1, 6.2, 7.1.3, 7.1.4, 7.1.5.1, 7.1.5.2, 7.1.6, 7.2, 7.3, 7.5.3, 8.5.2, 8.5.6, 8.6, 8.7, 9.1.1, 9.1.3, 10.2
6	Human resource (Training, Motivation activities, Manpower recruitment)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2, 7.3, 7.5.3, 9.1.3, 10.2
7	Information technology (Hardware & software provision and updation, control to access the application system & Data integrity)	4.1, 4.2, 6.1, 6.2, 7.1.3, 7.5
8	Quality Management System (Control of documents, Control of records, Corrective & Preventive action, Control of NC products, Internal quality audit, Management review meeting, Continual improvement process)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2, 7.5.3, 8.5.2, 8.5.3,8.7, 9.1.3, 10.2
9	Store &Dispatch (Handling, storage, Preservation, Issue of material, Packing, Dispatch planning & Transportation)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2, 7.5.3, 8.5.2, 8.5.3, 8.5.4, 8.7, 9.1.3, 10.2
10	Maintenance (Preventive, Predictive, Breakdown Maintenance and Periodic overhauling)	4.1, 4.2, 6.1, 6.2, 7.1.3, 7.1.6, 7.2, 7.3, 7.5.3, 9.1.3, 10.2
11	Tool Room (Tool design, Tool Manufacturing & Tool Maintenance)	4.1, 4.2, 6.1, 6.2, 7.1.3, 7.1.6, 7.2, 7.3, 7.5.3, 9.1.3, 10.2
12	Engineering (ECN/ECR (External), PCN (Internal), APQP, PPAP)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2,7.3,8.3,8.7,8.5.3, 10.2

Input required & output expected for all processes-Turtle Annexure-06 of Q.M
Sequences & Interaction of the above processes – Annexure-04 of Q.M
Performance indicators have been determined for the above processes-
Resources has been determined for the above processes & availability has been ensured
Responsibilities & authorities have been assigned –Annexure-02 of Q.M
Risk & opportunities have been addressed-Annexure-03 of Q.M
Processes are evaluated & implemented any change if required to ensure the achievement of indented results
Improvement is done in the processes & QMS- Ref. Kaizen sheet

4.4.1.1 Conformance of products and processes

Customer, statutory & regulatory requirements are identified for all products & processes and conformance for the same are ensured during process design & development, Manufacturing & Procurement. XXX ensures conformance of all products and processes and those that are outsourced, to all applicable customer, statutory, and regulatory requirements.

XXX do not produce any service parts for any of the customer.

4.4.1.2 Product safety

XXX has documented process for the management of product-safety related products and manufacturing processes, which shall include but not be limited to the following, where applicable:

identification by the organization of statutory and regulatory product safety requirements;
customer notification of requirements in item a);
special approvals for design FMEA;
identification of product safety-related characteristics;
identification and controls of safety-related characteristics of product and at the point of manufacture;
special approval of control plans and process FMEA;
reaction plans
defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification;
training identified by the organization or customer for personnel involved in product-safety related products and associated manufacturing processes;
changes of product or process are approved prior to implementation, including evaluation of potential effects on product safety from process and product changes
transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources
product traceability by manufactured lot (at a minimum) throughout the supply chain
lessons learned for new product introduction.

Note: Special approval is an additional approval by the function (typically the customer) that is responsible to approve such documents with safety-related content.

Ref- Documented process product safety

4.4.2 XXX:
a) maintains documented information to support the operation of its processes;
b) retains documented information to have confidence that the processes are being carried out as planned.

Ref-List of records with retention period

5.0 Leadership

5.1 Leadership and commitment

5.1.1 General

Director is accountable for the effectiveness of the quality management system
Quality Policy, Objectives/KPI with action plan are established
QMS requirements are integrated into the business process &addressed in the documented process of the related business processes. (Marketing,Purchase, Production, Quality, Maintenance, Tool Room, Store, Dispatch, Top Management, Engineering, Quality management system, Human resource, Information technology)
PFMEA is done for manufacturing process & risk assessment is done for all business process & action is taken for improvement where ever is required
Resources needed for the QMS are identified during management review and fulfilled by the management
Training is imparted on the requirements of QMS and related documented processes for effective implementation of QMS throughout the organization
Internal audit is done at planned intervals to ensure the QMS achieves its indented results
Kaizens/suggestion schemes are promoted through out the organization to promote improvements
Support the lower management & workers to contribute the effectiveness of the quality management system

5.1.1.1 Corporate responsibility

XXX has defined and implemented corporate responsibility policies, including at a minimum

Anti bribery policy

XXX is committed to the prevention and detection of fraud, bribery and all other corrupt business practices. It is XXX’s policy to conduct all of its business activities with honesty, integrity and the highest possible ethical standards and actively enforce its business practice, wherever it operates throughout the world, of not engaging in bribery or corruption.

2. Employee code of conduct

We promote freedom of expression and open communication. But we expect all employees to follow our code of conduct. They should avoid offending, participating in serious disputes and disrupting our workplace. We also expect them to promote a well-organized, respectful and collaborative environment.

3. Compliance with law

All employees must protect our company’s legality. They should comply with all environmental, safety and fair dealing laws. We expect employees to be ethical and responsible when dealing with our company’s finances, products, partnerships and public image.

4. Respect in the workplace

All employees should respect their colleagues. We won’t allow any kind of discriminatory behavior, harassment or victimization. Employees should conform with our equal opportunity policy in all aspects of their work, from recruitment and performance evaluation to interpersonal relations.

5. Protection of Company Property

All employees should treat our company’s property, whether material or intangible, with respect and care. Employees:

Shouldn’t misuse company equipment or use it frivolously.
Should respect all kinds of incorporeal property. This includes trademarks, copyright and other property (information, reports etc.) Employees should use them only to complete their job duties.
Employees should protect company facilities and other material property (e.g. company cars) from damage and vandalism, whenever possible.

6) Whistle Blowing Policy

a) Objective & Scope

To provide a framework to employees to report in good faith, in case they observe unethical & improper practices or any alleged wrongful conduct in the organization & to protect employees who raise such concerns about serious irregularities in the organization

Scope: All employees of XXXX

b) Policy guidelines

Protected discloser
Subject
Whistle blower
HOD H.R email xx@xx.xx

c) Procedure & Discloser

Any employee observed him self/her self any unethical & improper practices or alleged wrong full conduct shall make a discloser to the HOD H.R in writing or email asap and later then 30 days of occurrence of the incidents
All discloser through email/mobile no.
Anonymous discloser will be entertained

d) Enquiry

HOD H.R will forward the complaint to the Director
Designation of committee by Director to investigate preferably from plant representative
External agency may be involved depending on the severity of the complaints if initial investigation reveals no basis / warrants, no further investigation the complaint will be dropped
In case initial enquiry reveals further investigation any information and document can be called as deemed appropriate by the committee
No attempt to conceal evidence
Report on completion of investigation to be made to Director
Next cores of action to be determined and may order for remedies

e) Disqualifications

No protection in this policy against bogus complaints
Whistle blowers to make protected discloser which have subsequently found to be malafide frivolous and malicious shall be liable to the prosecuted under company code of conduct

f) Secrecy/ confidentiality

The whistle blower the subject and every one involve in the process shall: –

Maintain complete confidentiality /secrecy of the matter
No discuss in meetings/informal gatherings/social get-together. Discuss only to the extent or with the person required for the purpose of completing the process & investigation
No keep any papers unattended anywhere at any time
Keep electronic mails/files under password

If any one is found not compliance with the above he/she can be held liable for such disciplinary action as dimmed fit

g) Protection

Designated authority will ensure that no adverse personal action shall be taken or recommended against an employee in retaliation to his /her discloser in good faith of any unethical and improper practices alleged wrongful conduct
No protection against adverse action which occur due to poor job performance or any other discloser made pursuant to this policy etc. depended of his discloser of unethical & improper practices or alleged wrongful conduct

h) Reporting

Quarterly report with the number of complaints received under the policy & their outcome shall be placed to the Director by the HOD H.R

5.1.1.2 Process effectiveness and efficiency

Performance indicators are made for product realization processes & support processes. Monthly review is done to evaluate & improve their effectiveness & efficiency and output is reviewed in Management review . Top management reviews the product realization processes and support processes to evaluate and improve their effectiveness and efficiency. The results of the process review activities are included as input to the management review. Top Management reviews the Production Realization Processes and support processes to assure the effectiveness and efficiency of the QMS through:

• the results of Manufacturing Process Audits,
• the Goals and Objectives Matrix ,
• general Quality Issues,
• Customer Complaints

These reviews are formally conducted during Management Review Meetings, but may also be addressed as part of the day-to-day business activities to assure the effectiveness and efficiency of our processes.

5.1.1.3 Process owners

Process owners are identified for all processes. Roles, responsibility & authorities are assigned and communicated

Ref- Organization chart

5.1.2 Customer focus

Top Management ensures that customer requirements are determined and are met with the aim of enhancing customer satisfaction. Customer Requirements may be determined through Quotations, Purchase Orders, Specifications; Customer provided Supplier Quality Manuals, as well as Customer Satisfaction and Dis-satisfaction data. To ensure that the defined customer requirements are being met, Top Management will rely on data from the Goals and Objectives Matrix and customer feedback (i.e. Customer Report Cards, and general customer communications). Top management demonstrates leadership and commitment with respect to customer focus by ensuring that:

Customer, statutory & regulatory requirements are identified for all products & processes and conformance for the same are ensured during process design & development, Manufacturing & Procurement
PFMEA is done for manufacturing process & risk assessment is done for all business process & action is taken for improvement where ever is required
Customer satisfaction/customer score card is monitored & action is taken to enhance satisfaction level

Actions will be taken as necessary to ensure that customer requirements are continually met and enhanced

5.2 Policy

5.2.1 Establishing the quality policy

Top management has established, implemented and maintained a quality policy that:

is appropriate to the purpose and context of the xxx and supports its strategic direction;
provides a framework for setting quality objectives;
includes a commitment to satisfy applicable requirements;
includes a commitment to continual improvement of the quality management system.

The quality policy is

“To meet or exceed customer expectation by supplying quality products at competitive prices & on-time deliveries by complying with all applicable requirements and through continual improvement of QMS”

Date-xx.xx.xxxx Sd-Director Operation

5.2.2 Communicating the quality policy

The quality policy is:

available and maintained as documented information ;
communicated by displaying at appropriate locations & understood by discussing policy commitments in meeting, via training and applied within the organization. Policy is communicated through display boards in English, Hindi.
Training is given to the employee time to time for the same to enhance understanding & effective implementation
available relevant interested parties by publishing on Web site.

5.3 Organizational roles, responsibilities and authorities

Responsibility & Authority are assigned, communicated & understood within the organization. Chief Manager System has the responsibility & authority for the followings

To conduct internal audits as per plant & ensure that the quality management system conforms to the requirements of this International Standard;
Review the Key performance indicators monthly to ensure that the processes are delivering their intended outputs;
Reporting on the performance of the quality management system and on opportunities for improvement in particular to Director as and when required & during Management review
Communicate the CSR within the organization to ensure the promotion of customer focus throughout the organization;
Review the Document change note for any change in the documents & engineering change note for any change in the product /process w.r.t the QMS requirements to ensure the integrity of the quality management system is maintained.

5.3.1 Organizational roles, responsibilities, and authorities -supplemental

Top management assigned personnel with the responsibility and authority to ensure that customer requirements are met. These assignments are documented. This includes but is not limited to the
a) selection of special characteristics,
b) setting quality objectives and related training,
c) corrective and preventive actions,
d) product design and development,
e) capacity analysis,
f) logistics information,
g) customer scorecards, and customer portals

HOD Engineering is responsible to ensure the fulfillment of customer requirements. Responsibility & authority has been defined, communicated & understood to HOD Engineering

5.3.2 Responsibility and authority for product requirements and corrective actions

Top management ensures that personnel responsible for conformity to product requirements have the authority to stop shipment and stop production to correct quality problems. Personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform to requirements to ensure that nonconforming product is not shipped to the customer and that all potential nonconforming product is identified and contained. Production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements.

HOD Quality has the authority to stop shipment and stop production to correct quality problems.
If any non-conformity occurred in the products or process then line in-charge/ Engineer QA/ inspector informs to Plant Head.
Plant Head with the help of Director takes the decision on the Nonconforming products & identified NC products are contained and prevent to ship to the customer
Night shift supervisor/Line in charge is responsible to ensue conformity to product requirements

6 Planning

6.1 Actions to address risks and opportunities

6.1.1 When planning for the quality management system, xxx consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvements.

Risk & Opportunities have been determined for the following processes

(Marketing, Purchase, Production, Quality, Maintenance, Tool Room, Store, Dispatch, Top Management, Engineering, Quality management system, Human resource, Information technology)

6.1.2 XXX plan:

actions to address these risks and opportunities;
how to:
- integrate and implement the actions into its quality management system processes
- evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities are proportionate to the potential impact on the conformity of products and services. Action has been initiated to Mitigate the risk & planning has been done in case of contingency. All actions have been integrated and implemented in the related documented processes and actions are evaluated monthly for the effectiveness

Ref-Risk assessment sheet

6.1.2.1 Risk analysis

XXX include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework. PFMEA is done for all manufacturing processes considering lesson learned from product recalls, product audits, filed returns & repairs, complaints, scrap & rework. XXX retain documented information as evidence of the results of risk analysis.

Ref- AIAG Manual PFMEA

6.1.2.2 Preventive action

XXX determines and implement action(s) to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the severity of the potential issues. XXX has established a process to lessen the impact of negative effects of risk including the following:

Potential non-conformities are identified during Risk analysis/PFMEA
Recommended actions are decided based on severity of the risk / potential issues
Root cause analysis is done for the potential Risk/issues/Nonconformity
Determine & implement the action needed to prevent nonconformity
evaluating the need for action lo prevent occurrence of nonconformities:
determining and implementing action needed;
documented information of action taken;
reviewing the effectiveness of the preventive action taken;
utilizing lessons learned to prevent recurrence in similar processes
Review the effectiveness of the action taken
Horizontal deployment in the similar processes

Ref- Documented process of Corrective &Preventive action

6.1.2.3 Contingency plans

Contingency plans made for continuity of supply in the event of any of the following:

key equipment failures interruption from externally provided products,processes, and services;
recurring natural disasters;
fire;
utility interruptions;
cyber-attacks on information technology systems;
labour shortages;
infrastructure disruptions;

Periodic test is done for all contingencies as per frequency given in contingency plan. Contingency plan is reviewed once in a year& update if required. Manager systems is authorized to change the contingency plan. Product Validation is done after emergency shutdown. For computers data backup and for emails auto back up done on NAS drive. Seqrite antivirus end point security admin console software available at XXXX to outcome Cyber attacks.

Ref- Contingency Plan(Annexure -09)

6.2 Quality objectives and planning to achieve them

6.2.1 Xxx has established quality objectives at relevant functions, levels and processes needed for the quality management system. The quality objectives shall:

be consistent with the quality policy;
be measurable;
take into account applicable requirements;
be relevant to conformity of products and services and to enhancement of customer satisfaction;
be monitored;
be communicated;
be updated as appropriate.

Quality objectives are established for the following processes

Marketing & Sales
Purchase
Production
Quality
Machine Maintenance
Tool Management, Storage
Packing & Dispatch
Top Management
New product development
Internal audit & control of documented information
Human resource development
Information technology)

XXX maintains documented information on the quality objectives.

Objectives are monitored monthly
Objectives are communicated with in the organization through display boards
Objective status is updated as per frequency mentioned in the sheet

Ref- Management policy deployment & objectives- F-02

6.2.2 Planning is done for all objectives. When planning how to achieve its quality objectives, the organization shall determine:

what will be done;
what resources will be required;
who will be responsible;
when it will be completed;
how the results will be evaluated

Ref- Management policy deployment & objectives- F-02

6.2.2.1 Quality objectives and planning to achieve them — supplemental

Top management ensures that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization. The results of the organization’s review regarding interested parties and their relevant requirements is considered when establishing its annual (at a minimum) quality objectives and related performance targets (internal and external).

Ref- Management policy deployment & objectives- F-02

6.3 Planning of changes

When XXX determines the need for changes to the quality management system, the changes are carried out in a planned manner. XXX consider:

the purpose of the changes and their potential consequences;
the integrity of the quality management system;
the availability of resources;
the allocation or reallocation of responsibilities and authorities.

For changes following documented processes are referred

For engineering/process change – Documented process to control of drawing & ECN

Form change in documents- Documented process for control of documents

7.0 Support

7.1 Resources

7.1.1 General

Top Management provides sufficient resources for the effect implementation of QMS. Resource requirements have been defined as equipment, manpower, and training needs. Resource requirements are formally addressed during Management Review Meetings but may be identified and provided for during normal day-to-day operations. Any associate may request additional resources while the Department Managers/Supervisors, and other members of Top Management have the defined responsibility and authority to determine if the need for the resource(s) is valid, required and feasible. When determining these resources, consideration will be given to:

Current business opportunities and constraints;
Mechanisms that will encourage innovative continual improvement;
Methods to enhance existing competency; and
Future resource requirements.

Requested resources may be needed

to implement and maintain the quality management system and continually improve its effectiveness
to enhance customer satisfaction by meeting customer requirements

Ref- List of machines
Ref- List of Monitoring & Measuring Equipment
Ref- List of Supplier (BOP, Outsourced processes& services (Calibration, Trainings, Transportations)
Ref- Skill Matrix & Competency Matrix
Capacity analysis is done as per the customer requirements and if required procurement is done for the required resources or arranged from external providers/suppliers

7.1.2 People

XXX determines and provide the persons necessary for the effective implementation of quality management system for the operation and control of it’s processes. Sufficient personnel are available for the effective implementation of QMS & for the operation & control of the processes

Ref- Skill Matrix & Competency Matrix with Education, skill& experience

7.1.3 Infrastructure

DAG determines, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Infrastructure includes:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology

Necessary infrastructure is determined, provided & maintained for the operation of its processes and to achieve conformity of products and services

Building 5000 sq. Yards
List of machines
List of Monitoring & Measuring equipment
List of Supplier (transporters/ Internal transport facilities)
Internal communication through mail & intercom
Soft data backup is taken on Server/external hard disc as per plan
Data Backup plan, License renewal plan, List of Service providers (Hardware & software)

7.1.3.1 Plant, facility, and equipment planning

XXX use a multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. In designing plant layouts, the XXX :
a) optimize material flow, material handling, and value-added use of floor space including control of nonconforming product, and
b) facilitate synchronous material flow, as applicable.

Methods are developed and implemented to evaluate manufacturing feasibility for new product or new operations. Manufacturing feasibility assessments include capacity planning. These methods are also applicable for evaluating proposed changes to existing operations. XXX maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance and verification of job set-ups. Assessments of manufacturing feasibility and evaluation of capacity planning are inputs to management reviews. Plant layout is design as per process flow of the product to optimize the material flow. Racks & Bins are provided for material handling & value added use of floor space. Manufacturing feasibility is reviewed for new product as well as change in the existing product. Assessment of manufacturing feasibility &evaluation capacity planning is reviewed in Management review (Once in six months). Cyber protection also provided to equipment and systems supporting manufacturing.

Ref- Plant layout
Ref- Process for APQP

7.1.4 Environment for the operation of processes

XXX determines, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. Suitable environment can be a combination of human and physical factors, such as:

social (e.g. non-discriminatory, calm, non-confrontational);
psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

XXX has ensured that :

Sufficient exhaust systems are provided for air flow at work place
PPE’s are provided wherever is noise level is grater than permissible limit
Sufficient fans, collars are provided at the work place to reduce the effect of increase in the temperature in summer season
Insulation is done under shed, to resist the heat at work place
Equal distribution of the work is ensured to prevent the stress building
Timely breaks are given to prevent burnout prevention such as lunch break, tea break

7.1.4.1 Environment for the operation of processes — supplemental

XXX maintain its premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs. Floor are maintained & repaired at regular intervals for smooth material flow in the work place. Daily cleaning is done to maintain dust free environment

7.1.5 Monitoring and measuring resources

7.1.5.1 General

XXX determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. XXX ensures that the resources provided:

Necessary monitoring & measurement resources are provided as per control plan, to ensure valid & reliable results.
Calibration/Verification is done at regular intervals to ensure their continuing fitness for their purpose
Equipment/Gauge history card is maintained

XXX retains appropriate documented information as evidence of fitness for purpose of the monitoring and measuring resources

Ref- List of Monitoring & Measuring equipment

7.1.5.1.1 Measurement systems analysis

Statistical studies are conducted to analyse the variation present in the results of each type of inspection, measurement, and test equipment system identified in the control plan. The analytical methods and acceptance criteria used shall conform to those in reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer. Records of customer acceptance of alternative methods are retained along with results from alternative measurement systems analysis

Prioritization of MSA studies focus on critical or special product or process characteristics.

MSA is planned for all type of inspection, measurement, and test equipment system as identified in the control plan
MSA plan is made for variable & attribute data

R&R study is conducted for variable data & kappa is for attribute data

MSA is conducted as per AIAG reference manual
MSA is planned once in a year & prioritization is done considering the special product or process characteristics

Ref- Documented process Management system analysis

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment are:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification is retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
XXX determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. XXX ensures that:

Calibration/Verification of the Monitoring & Measuring resources are done as per plan
All calibration is traceable to NPL (National physical laboratory)
MME are identified after calibration with sticker
All MME are safeguarded from adjustments, damage or deterioration
Previous measuring results are validate if equipment found unfit after calibration

Ref- Documented process for control of monitoring & measuring resources

7.1.5.2.1 Calibration/verification records

XXX have a documented process for managing calibration/verification records.
Record of the calibration/verification activity for all gauges and measuring and test equipment (including employee-owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment) needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements are retained. XXX ensure that calibration/verification activities and records include the following details:
a) revisions following engineering changes that impact measurement systems;
b) any out-of-specification readings as received for calibration/verification;
c) an assessment of the risk of the intended use of the product caused by the out of-specification condition;

d) when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment are retained, including the associated standard’s last calibration date and the next due date on the calibration report;
e) notification to the customer if suspect product or material has been shipped;
f) statements of conformity to specification after calibration/verification;
g) verification that the software version used for product and process control is as specified;
h) records of the calibration and maintenance activities for all gauging (including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment);
i) production-related software verification used for product and process control (including software installed on employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment).

Ref- Documented process for control of monitoring & measuring resources

7.1.5.3 Laboratory requirements

7.1.5.3.1 Internal laboratory

At present XXX’s do not have internal laboratory for Inspection, testing and calibration

7.1.5.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test, or calibration services by XXX have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either -the laboratory is accredited to ISO / IEC 17025or national equivalent and include the relevant inspection, test, calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or -XXX uses external laboratory which is acceptable to the customer. XXX uses Material testing & calibration services from form outside NABL certified Lab / equipment manufacturer when a qualified laboratory is not available.

External lab are selected on the basis of NABL accreditation — where an accredited laboratory is not available (e.g., for specialist or integrated equipment, or for parameters with no international traceable standard reference), XXXX ensure that there is evidence that the laboratory has been evaluated and meets the requirements of ISO / IEC 17025

Ref- Master List of approved supplier (NABL accredited lab)

7.1.6 Organizational knowledge

XXX determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge is maintained and be made available to the extent necessary. When addressing changing needs and trends, XXX consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives. Organizational knowledge can be based on:
a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);
b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers)

Ref- Knowledge matrix

7.2 Competence

Personnel performing work affecting conformity to product requirements will display competence to perform tasks based on appropriate education, training, skills and experience. Competence has been defined as the demonstrated ability to apply knowledge and skills, while skills have been identified as proficiency and dexterity in performing tasks.Competency Norms is made for all designation as per organization chart with required qualification, training, skill & experience Skill matrix/Competency matrix is made with actual qualification, skill & experience.

Training is provided where ever is required to acquire the necessary competency
Training record is maintained for the same

7.2.1 Competence — supplemental

The Department Managers/Supervisors, with assistance from Top Management, will

define the necessary competence for personnel performing work affecting conformity to product requirements via Job Descriptions. The Job Descriptions will include recommended minimum qualifications (such as education, experience and skills) to enter a position. Additional training will assist in providing the necessary knowledge and skills needed for an employee to be considered competent in their respective job task.
identify and provide training to support initial qualifications, promote and achieve employee competencies and promote employee development
evaluate the effectiveness of the training provided
ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. This may be accomplished through any of the following methods:
- Training (including Orientation and/or other training programs)
- A variety of Quality and/or Safety Meetings
- Internal Audit Activities
maintain appropriate records of education, training, skills and experience

Ref- Documented process for Training

7.2.2 Competence — on-the-job training

XXX provides on-the-iob training (which shall include customer requirements training) for personnel in any new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements; this includes contract or agency personnel. The level of detail required for on job training subject to the level of education, the personnel possess and the complexity of tasks they are required to perform for their daily work. Persons whose work can affect quality is informed about the consequences of nonconformity to customer requirements. On job training is provided to the concerned personnel (Operators, Inspectors & supervisors, Contractual workers etc.) involved in new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements; SOP, Instrument reading, Machine setting, Limit samples, Safety, Attribute inspection (Gauges/Visuals), Instruments readings etc. are covered during on job training.Operators, Inspectors & supervisors, Contractual workers etc are well aware about the consequences of nonconformity to customer requirements

7.2.3 Internal auditor competency

XXX documented process(es) to verify that internal auditors are competent, taking into account any customer-specific requirements. XXX maintain a list of qualified internal auditors. Quality management system auditors, manufacturing process auditors, and product auditors are competent to demonstrate the following minimum competencies:

understanding of the automotive process approach for auditing, including risk-based thinking;
understanding of applicable customer-specific requirements;
understanding of applicable ISO 9001 and IATF 16949 requirements 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, and close out audit findings. Additionally, manufacturing process auditors shall demonstrate technical understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (such as FMEA) and control plan.
Product auditors shall demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity where training is provided to achieve competency, documented information is retained to demonstrate the trainer’s competency with the above requirements.
Maintenance of and improvement in internal auditor competence is demonstrated through:
1. executing a minimum number of audits per year, as defined by the organization; and
2. maintaining knowledge of relevant requirements based on internal changes (e.g., process technology, product technology) and external changes (e.g., lso 9001, IATF 16949, core tools, and customer specific requirements).

Ref- Documented process Internal audit

7.2.4 Second-party auditor competency

Second party auditor(s) are competent. Second party auditor is also gone through the same training process as an Internal auditor. Second party auditor(s) are trained through competent person minimum two days internal auditor training program. Trainer competency record is maintained. Second party auditor(s) are able to demonstrate the minimum following core competencies, including understanding of

The automotive process approach to auditing, including risk based thinking;
Applicable customer and organization specific requirements;
Applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
Applicable manufacturing process (es) to be audited, including PFMEA and control plan;
Applicable core tool requirements related to the scope of the audit;
How to plan, conduct, prepare audit reports, and close out audit findings.

Manufacturing process auditors have technical understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (such as PFMEA) and control plan. Product auditors have competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity. Trainings are provided to Internal auditors to achieve required competence.

Reference Documented process-Supplier QMS development

7.3 Awareness

Persons doing work under the organization’s control are aware of:

The quality policy;
Relevant quality objectives
Their contribution to the effectiveness of the quality management system, including the benefits of improved performance;
The implications of not conforming to the quality management system requirements.

7.3.1 Awareness — supplemental

XXX maintain documented information that demonstrates that 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 risks involved for the customer with nonconforming product. Training Plans, records & effectiveness evaluation records are maintained to demonstrates that 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 risks involved for the customer with non-conforming product.

7.3.2 Employee motivation and empowerment

XXX maintain a documented process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment that promotes innovation. The process includes the promotion of quality and technological awareness throughout the whole organization.

Ref-Documented process for employee’s motivation

7.4 Communication

XXX determine the internal and external communications relevant to the quality management system, including:
a. on what it will communicate;
b. when to communicate;
c. with whom to communicate;
d. how to communicate

Ref- Communication Matrix

7.4 Documented information

7.5.1 General

XXX’s quality management system include:

documented information required by this International Standard;
documented information determined by the XXX as being necessary for the effectiveness

Ref-List of Internal documents

7.1.5.1 Quality management system documentation

Quality Management system is documented & includes the Quality Manual , Issue No.00, and dated xx.xx.xxxx. Compliance with requirements of this International standard are addressed in this quality manual. Quality manual includes the followings

Scope of the QMS with justification for exclusion – Ref 4.3 & 4.3.2
List of documented processes- Ref- Annexure No.07
Process sequence & interaction- Ref- Annexure No.04
Type and extent of control of any outsourced processesRef- 8.1
Customer specific requirement ( i.e Table or a matrix) –Ref- CSR Matrix-Annexure-08

7.5.2 Creating and updating

When creating and updating documented information, ,XXX ensure appropriate:

identification and description (e.g. a title, date, author, or reference number);
format (e.g. language, software version, graphics) and
media (e.g. paper, electronic);

Ref-Documented process control of documents& records

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this International Standard is controlled to ensure:

it is available and suitable for use, where and when it is needed;
it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 For the control of documented information, XXX address the following activities, as applicable:

distribution, access, retrieval and use;
storage and preservation, including preservation of legibility;
control of changes (e.g. version control);
retention and disposition.
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified as appropriate, and be controlled. Documented information retained as evidence of conformity is protected from unintended alterations.

Ref-Documented process control of documents& records

7.5.3.2.1 Record retention

XXX define, document, and implement a record retention policy. The control of records satisfy statutory, regulatory, organizational, and customer requirements. Production part approvals, tooling records (including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts and amendments are retained for the length of time that the product is active for production and service requirements, plus one calendar year, unless otherwise specified by the customer or regulatory agency. XXX ensures:

All records are retained as per the retention period defined in List of Internal documents
Retention periods after considering the statutory, regulatory, Organization & customer requirements
PPAP, Tooling, APQP, Contracts/Purchase orders/Amendments are retained for the length of time that the product is active for production and service requirements, plus one calendar year

Ref-List of Internal documents

7.5.3.2.2 Engineering specifications

XXX have a documented process describing the review, distribution, and implementation of all customer engineering standards/specifications and related revisions based on customer schedules, as required. XXX retain a record of the date on which each change is implemented in production implementation includes updated documents. Review should be completed within 10 working days of receipt of notification of engineering standards/specifications changes. A change in these standards/specifications may require an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of the production part approval process, such as control plan, risk analysis (such as FMEAs), etc.

Ref-Documented process for control of drawing & ECN

8.0 Operation

8.1 Operational planning and control

XXX ensures

Requirements of the products are determined during Drawing study, Feasibility review & Advance product quality planning
Control plans /SOPs are made for the Product & Processes and criteria for the acceptance is established for the same
Resources such as Machines, Monitoring & measuring equipment, Tools/jig/fixtures are determined during Drawing study, Feasibility review & Advance product quality planning to achieve conformity to the product and service requirements
Incoming, In-process & Final inspection are carried out to demonstrate the conformity of products and services to their requirements
Planned changes are controlled and consequences of unintended changes are reviewed
Actions are taken to mitigate any adverse effects, as necessary
Outsourced processes are controlled as follows

S.No.	Out sourced process	Control
1	Plating, Rough Machining, Heat Treatment& Sheet Metal job work	Supplier system audit, Incoming inspection, Process audit, Product audit
3	Calibration& Testing	NABL accredited lab
4	AMC for CNC, VMC, DG Set , Plasma Cutting Machine & Compressors	Review the service report, Plan compliance & monitor the MTBF

8.1.1 Operational planning and control — supplemental

When planning for product realization, the following topics have been included:

Customer’s supplied drawings/specifications
Packing specifications/requirements
Manufacturing feasibility review
APQP
Acceptance criteria for the product
customer product requirements and technical specifications;
logistics requirements;
manufacturing feasibility:
project planning
The resources identified refer to the required verification, validation,monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance.

8.1.2 Confidentiality

XXX ensure the confidentiality of customer-contracted products and projects under development, including related product information. Confidentiality of customer-contracted products and projects under development, including related product information are maintained by the organization as follows

Controlling the distribution of the drawings/specification
Distribution of all drawings/specification (if required) is done after removing the customer name from drawings
Issue record is maintained by the Manager system
No drawings/specification is issued without written approval of the Director

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with the customer are done for product, processes, enquiries, contracts/amendments, feed back, customer property & contingency actions as per communication matrix as mentioned in competency matrix.

Communication with customers include:

providing information relating to products and services;
handling enquiries, contracts or orders, including changes;
obtaining customer feedback relating to products and services, including customer complaints;
handling or controlling customer property;
establishing specific requirements for contingency actions, when relevant

8.2.1.1 Customer communication — supplemental

Written or verbal communication is in the language agreed with the customer. XXX have the ability to communicate necessary information, including data in a customer-specified Computer language and format (e.g.,computer-aided design data, electronic data interchange)’Written or verbal communication is done with the customer in English/local language. Necessary information is communicated through PDF, Microsoft office, CAD, Solidworks etc.

8.2.2 Determining the requirements for products and services

After receiving the enquiry for product, the followings requirements are determined during drawing study/feasibility review

List of Applicable statutory and regulatory requirements related to product.
List of applicable National/International/Customer’s specified standards.
List of special/safety characteristics.
List of manufacturing processes.
List of necessary resources (Machine, Tool/Jig/fixtures, Monitoring & measuring equipment).
List of Raw material/B.O.P/Outsourced processes

Ref- Team feasibility commitment

8.2.2.1 Determining the requirements for products and services — supplemental

These requirements include recycling, environmental impact, and characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes includes but not be limited to the following:

all applicable government,
safety, and environmental regulations related to acquisition,
storage, handling, recycling, elimination, or disposal of material.
Environment impact of the manufacturing processes
Compliance to all applicable government, safety & environment regulations related to acquisition, storage, handling, recycling, elimination, or disposal of material

Ref- Legal Register

8.2.3 Review of the requirements for products and services

8,2,3,1 Contract review is carried out before committing to supply product to a customer for the followings

Applicable statutory and regulatory requirements related to product
Any applicable country specific requirements
Packing specifications & logistic requirements
Cost, Delivery & Volume
Includes the amendment if any

Contract review record is maintained for the same

Ref- Contract review checklist

8.2.3.1.1 Review of the requirements for products and services — supplemental

If customer gives the waiver for formal contract review then documented information is maintained for the same

8.2.3.1.2 Customer-designated special characteristics

Customer requirements are conformed for designation, approval documentation, and control of special characteristics through mail of feasibility conformation

8.2.3.1.3 Organization manufacturing feasibility

XXX utilizes a multidisciplinary approach to conduct an analysis to determine if it is feasible that the organization’s manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer. XXX conducts this feasibility analysis for any manufacturing or product technology new to the organization and for any changed manufacturing process or product design. Additionally, XXX validate through production runs, benchmarking studies, or other appropriate methods, their ability to make product to specifications at the required rate. Cross-functional team does the manufacturing feasibility for new/ modified product/ manufacturing process for the followings

Whether machines/processes are capable to meet the desired specification
Whether special characteristics can meet the desired process capability index (Cpk>=1.33)
Whether sufficient resources (Tools, Instruments, Machines) are available to produce the product with in desired specification
Whether any outsourced process is required for the product

Validation is done through production trial run to make product to specifications at the required rate

8.2.3.2 The organization shall retain documented information, as applicable: Contact review record & any new requirements for the products and services is retained

8.2.4 Changes to requirements for products and services

XXX ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed. When the requirements for products and services are changed, revised work order/schedule is issued to the Production, QA, Purchase, Packing & dispatch,

Ref- Documented process of customer enquiry & order processing

8.3 Design and development of products and services

8.3.1 General

Manufacturing Process design & development has been established to ensure the subsequent provision of products & processes

8.3.1.1:Design and development of products and services — supplemental

Manufacturing process design and development is focused on error prevention rather than detection.XXX document the design and development process.

8.3.2 Design and development planning

APQP time line chart is made for the manufacturing process design & development planning, considering the followings

Design & development phase- Four phases
- Planning & defining: The initial step of the product quality planning process is to ensure that customer needs and expectations are clearly understood
- Process design & development: This step is designed to ensure the comprehensive development of an effective manufacturing system. The manufacturing system must assure that customer requirements, needs and expectations are met
- Process Validation: Validating the manufacturing process through an evaluation of a significant production run. During a significant production run, the Development team validate that the control plan and process flow chart are being followed and the products meet customer requirements. Additional concerns are identified for investigation and resolution prior to regular production runs.
- Feedback, Assessment & Corrective action: Quality planning does not end with process validation and installation. It is the component manufacturing stage where output is evaluated when all special and common causes of variation are present. This is also the time to evaluate the effectiveness of the product quality Planning effort. The production control plan is the basis for evaluating product or service at this stage. Variable and attribute data are evaluated. Appropriate actions are taken.
Responsibilities and authorities involved in the design and development process are Defined in project organization chart/APQP time line chart
Required resources are determined & planned for product/process
Review meeting is carried out at planned intervals and if required customers and supplier are called for the meeting

8.3.2.1 Design and development planning — supplemental

Cross-functional team is responsible for design & development planning & includes the following members

Internal; Marketing, Purchase, Process design & development, Production, Q.A, Tool room

External (if required): Customer, Supplier

Cross-functional team involves in the following activates

Advance product quality planning
Manufacturing process design activities
Development & review of Process flow diagram
Development & review of Failure mode & effect analysis
Development & review of Control plan & SOP
Correction & corrective action against customer feed back

Ref-Documented process for Advance product quality planning

8.3.2.2 Product design skills

XXX ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable product design tools and techniques. Applicable tools and techniques are identified by XXX.

Manufacturing Process design skills

Solid Works, Auto CAD and 3D Printing

Ref- List of Competent personnel to operate the above Software

8.3.2.3 Development of products with embedded software

At present no product is developed with embedded software

8.3.3 Design and development inputs

Essential requirements are determined for the product to be develop considering the follows

Functional and performance requirements as mentioned in the drawings
Information derived from previous similar design and development activities;
Statutory and regulatory requirements;
Standards or codes of practice that the organization has committed to implement;
Potential consequences of failure due to the nature of the products.

If there is any conflict/clarity required regarding inputs, then Project Head, resolved it after discussion with the customer. Inputs records are maintained & retained in APQP file

8.3.3.1 Product design input

XXX manufacture products as per customer requirements so requirements of this clause are not applicable.

8.3.3.2 Manufacturing process design input

Manufacturing process design input requirements includes the following

Engineering drawing / specification provided by customer
Special characteristics determined by the customer
Target productivity, Time, process capability & cost
Any alternate manufacturing method-if any
Customer specific requirements- if nay
Experience from previous development
New material
Material handling & ergonomics requirements in production
Design for manufacturing and design for assembly
Use of error proofing methods wherever feasible

8.3.3.3 Special characteristics

Multidisciplinary Approach used to identifying the special characteristics including those

Determined by the customer (Ref-Product Drawing) and Risk Analysis ( PFMEA) performed by CFT
Special characteristics includes in the followings documents PFMEA, Control plan, SOP/W.I
Define the control & monitoring strategies for special characteristics in the PFMEA, Control plan, SOP/W.I
Take the approval from the customer for defined controls if required
Use the customer specified definitions &symbol
At present there is no equivalent symbol is used by Tech Auto, if used in future then symbol conversion table will be made &submit to the customer-if required

8.3.4 Design and development controls

Followings controls are applied to control the design & development process

the results to be achieved are defined
Timely review the status of all stages as defined in APQP time line chart
Incoming, in process & Layout inspection of the product
verification activities are conducted to ensure that the design and development outputs meet the input requirements;
Validation of the manufacturing processes & product- where ever is feasible
Take correction & corrective action against the observed nonconformities
Documented information of these activities is retained

8.3.4.1 Monitoring

Measurements at specified stages during the design and development of products and processes shall e defined, analyzed, and reported with summary results as an input to management review. When required by the customer, measurements of the product and process development activity is reported to the customer at stages specified, or agreed to, by the customer. When appropriate, these measurements may include quality risks, costs, lead times, critical paths, and other measurements. Measurement stages are defined, analyzed & reported with APQP time line chart and related annexures as an input of the Management review. When required by the customer, status of APQP time line chart is shared with the customer

Ref-APQP time line chart

8.3.4.2 Design and development validation

Validation of the manufacturing process is done in house for new product. Product is developed as per customer drawing and samples are submitted to the customer. The customer does validation for the same and results are communicated to us through mail / inspection report

8.3.4.3 Prototype programme

At present there is no requirement of prototype programme & control plan by the customer.

8.3.4.4 Product approval process

PPAP documents as per AIAG ref PPAP Manual is submitted to the customer. Default submission level is III unless otherwise specified by the customer.
Externally provided products & processes are approved as per the requirements addressed in Section 8.4.3
PFD, PFMEA,Control plan &PSWare taken from the supplier for PPAP approval
The organization shall obtain documented product approval is obtained by the customer prior to shipment, if required
Records of such approval is retained

Ref-Documented process for Production part approval process

8.3.5 Design and development outputs

C.F.T ensure that the design and development outputs:

Meet the input requirements;
Are adequate for the subsequent processes for the provision of products and services;
Include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
Specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

HOD NPD retains documented information on design and development outputs.

8.3.5.1 Design and development outputs — supplemental

XXX manufacture products as per customer requirements so requirements of this clause are not applicable.

8.3.5.2 Manufacturing process design output

Manufacturing process design output includes the followings

Engineering specifications/Drawings
Special characteristics for product and manufacturing process
Tools/Dies for production
Monitoring & Measurement equipment
Process Flow Diagram
Floor plan layout
Capacity analysis
PFMEA
Control plan including error proofing methods,SOP/W.I
Results of Initial process capability & Measurement system analysis
Packing specification

8.3.6 Design and development changes

Engineering identify, review & control changes made during or subsequent to, the design and development of products. Documented information is retained for the followings

Engineering change note for design & development changes & results of review
HOD Engg. is authorized to change after consulting with the customer
Correction/corrective action report to prevent adverse impacts.

8.3.6.1 Design and development changes — supplemental

C.F.T evaluate all changes (for potential impact on fit, form, function, performance, and/or durability) after initial product approval, including those proposed by the organization and Suppliers. All changes are validated against customer requirements & approved by Director or by the customer (if required) prior to the implementation in production

Ref-Documented process for ECN

8.4 Control of externally provided processes, products and services

8.4.1 General

XXX ensure that externally provided processes, products and services conform to requirements. XXX determine the controls to be applied to externally provided processes, products and services when:
a) products and services from external providers are intended for incorporation into XXX’s own products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of XXX;
c) a process, or part of a process, is provided by an external provider as a result of a decision by XXX. XXX determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide

S.No.	Externally provided Processes/product	Controls
S.No.	Externally provided Processes/product	External providers	Products (Output)
1	BOP	System audit	Incoming Inspection, Product audit
2	Raw Material	System audit	Incoming inspection
3	Outsourced process (Plating, Machining, sheet metal job work &Heat-Treatment)	Process audit	Incoming Inspection
4	Heat Treatment of tools/ dies	Supplier assessment	Verification of Supplier Test certificates

Criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements has been determined. Documented information of these activities and any necessary actions arising from the evaluations is retained

Ref-List of outsource process & control

8.4.1.1. General — supplemental

XXX include all products and services that affect customer requirements such as sub assembly, sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products, processes, and services.

S.No.	Externally provided processes/product	Controls
1	Calibration services	NABL accreditation lab & traceability with N.P.L

8.4.1.2 Supplier selection process

XXX have a documented supplier selection process. The selection process shall include:

an assessment of the selected supplier’s risk to product conformity and uninterrupted supply of XXX’s product to their customers;
relevant quality and delivery performance:
an evalualion of the supplier’s quality management system;
multidisciplinary decision making; and
an assessment of software development capabilities, if applicable.

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 (e.g., people, infrastructure);
design and development capabilities (including project management);
manufacturing capability;
change management process;
business continuity planning (e.g., disaster preparedness, contingency planning); logistics process;
customer service.

Ref-Documented process – Supplier selection

8.4.1.3 Customer-directed sources (also known as “Directed–Buy”)

Products, Material & processes are purchase from customer directed sources if specified by the customer &it mentioned in the list of approved supplier. Supplier selection process requirements are skipped for the customer directed sources

8.4.2 Type and extent of control

XXX ensure that externally provided processes, products and services do not adversely affect XXX’s ability to consistently deliver conforming products and services to its customers. XXX:

ensure that externally provided processes remain within the control of its quality management system;
define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;
take into consideration:
- the potential impact of the externally provided processes, products and services on XXX’s ability to consistently meet customer and applicable statutory and regulatory requirements;
- the effectiveness of the controls applied by the external provider; d) determine the verification, or other activities, necessary

S.No.	Externally provided Processes/product	Controls
S.No.	Externally provided Processes/product	External providers	Products (Output)
1	BOP	System audit	Incoming Inspection, Product audit
2	Raw Material	System audit	Incoming inspection
3	Outsourced process (Plating, Machining, sheet metal job work & Heat-Treatment)	Process audit	Incoming Inspection
4	Heat Treatment of tools/ dies	Supplier assessment	Verification of Supplier Test certificates

8.4.2.1 Type and extent of control — supplemental

XXX have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements. The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks.

Ref-Documented process – Purchase and List of outsource process & control

8.4.2.2 Statutory and regulatory requirements

Applicable Statutory & regulatory requirements are determined & recorded in the list of Parts
Applicable Statutory & regulatory requirements are communicated to the supplier through Purchase order
Compliance with the applicable Statutory & regulatory requirements/customer defines special controls for certain products are verified during system audit, product audit & incoming inspection

8.4.2.3 Supplier quality management system development

Supplier quality management system is developed through the following sequence. Unless otherwise authorized by the customer a QMS certified to ISO 9001 is the initial minimum acceptable level of development. Based on current performance and the potential risk to the customer, the objective is to move suppliers through the following QMS development progression:

Certification to ISO 9001:2015 through accredited certification body (accreditation mark of a recognized IAF MLA member and where the accreditation body’s main scope includes management system certification to ISO/IEC 17021)
Compliance to customer specific requirements (if applicable)
Compliance to IATF 16949 requirements through second party audit
Certification to IATF 16949 through third party audits (valid third-party certification of the supplier to IATF 16949 by an IATF-recognized certification body).
If supplier is not ISO 9001 certified then customer authorization is taken along with the development plan (Suppliers like Transporters and Logistic Support will be added in Development Plan)

8.4.2.3.1 Automotive product-related software or automotive products with embedded Software

XXX do not manufacturer automotive products related software or automotive product with embedded software.

8.4.2.4 Supplier monitoring

XXX have a documented process and criteria to evaluate supplier performance in order to ensure conformity of externally provided products, processes, and services to internal and external customer requirements. At a minimum, the following supplier performance indicators are monitored:

delivered product conformity to requirements;
customer disruptions at the receiving plant, including yard holds and stop ships;
delivery schedule performance;
number of occurrences of premium freight.

lf provided by the customer, XXX shall also include the following, as appropriate, in their supplier performance monitoring:

special status customer notifications related to quality or delivery issues;
dealer returns, warranty, field actions, and recalls.

Ref-Documented process – Supplier evaluation & monitoring

8.4.2.4.1 Second-party audits

Competent auditors do the Second part audit for Raw Material, BOP & Outsourced providers related to product at planned intervals for the followings

Supplier QMS development
Product audit
Process audit
Compliance with CSR (if any)

Audit frequency& scope are determined as follows

S.No.	Parameter	Frequency	Scope of audit
1	High risk/Safety product/Low performance / Not certified	12 Months	System, Product, Process & CSR (if any)
2	Medium performance / ISO 9001:2015 certified	15 Months	System, Product, Process & CSR (if any) and Third party audit report with Corrective action (annually)
3	Excellent performance & /ISO 9001:2015 certified	18 Months	System, Product, Process & CSR (if any) and Third party audit report with Corrective action (annually)
4	Excellent performance &IATF certified	24 Months	Product, Process & CSR (if any) and Third party audit report with Corrective action (annually)

8.4.2.5 Supplier development

Supplier development priority is determined as follows

S.No.	Parameter	Priority
1	High risk/Safety product/Low performance / Not certified	First
2	Medium performance / ISO 9001:2015 certified	Second
3	Excellent performance &ISO 9001:2015 certified	Third
4	Excellent performance & IATF certified	Least / Not required

Correction/Corrective actions are taken to resolve open (unsatisfactory) performance issues and pursue opportunities for continual improvement

Ref-Documented process – Supplier QMS development

8.4.3 Information for external providers

Following requirements are communicated to the external providers through Purchase orders

Drawing Number, Revision Number on Purchase order for B.O.P along with drawing
Material specification (Size & grade) for raw material
Product specification for outsourced processes
Validation of the special process (Plating)
Competency of the personnel involve in special process
Commercial terms & conditions
Statutory/regulatory requirements and special characteristics related to product/process- if any
Customer defines special controls for certain products – if any
Material test certificate along with material (Raw material)
PDI report for B.O.P & Outsourced processes
Verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises
Performance are communicated to the supplier through mail if requested by the supplier
Plant head &HOD purchase review the requirements for adequacy prior to communication with supplier

8.4.3.1 Information for external providers — supplemental

All applicable statutory and regulatory requirements and special product and process characteristics are communicated to the supplier through purchase orders
Above requirements are communicated to the down line at the point of Manufacture by the suppler
Effective communication& compliance of the above requirements are verified during second party audit

8.5 Production and service provision

8.5.1 Control of production and service provision

Production/ Manufacturing of the product is done under controlled condition, which includes the followings

Control plan that defines the characteristics of the products & processes
Availability of monitoring & measuring equipment for product & process as per control plan
Incoming inspection, In-process inspection & Final inspection are carried out to verify the compliance with control plan
Use of Machines, Tools/Dies/Jig/fixtures are per control plan
Appointment of competent person as per skill matrix/competency norms
Validation of the process is done as per plan
Revalidation at least once in a year or any change in the process parameter/product parameter/Material
Error proofing method where ever is necessary
Packing is done as per the packing specification sheet
PDI/Final inspection is carried out before dispatch

8.5.1.1 Control plan

Control plan has been developed for pre-launch & production for all Products including Raw material, BOP & Outsourced processes and shows linkage and incorporates information from PFD & PFMEA.

Prelaunch: A description of the dimensional measurements, material, and performance tests that occur after prototype and before full production. Pre- launch is defined as a production phase in the process of product realization that may be required after prototype build.

Production: Documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production.

Control plan includes the followings

General data
- Control plan number
- issue date and revision date, if any
- customer information (see customer requirements)
- organization’s name/site designation
- part number(s)
- part name/description
- engineering change level
- phase covered (prototype, pre-launch, production)
- key contact
- part/process step number
- process name/operation description
- functional group/area responsible.
Product control
- Product-related special characteristics;
- other characteristics for control (number, product or process)
- specification/tolerance;
Process control
- Process parameters (including process settings and tolerances);
- process-related special characteristics;
- machines, jigs, fixtures, tools for manufacturing (including identifiers, as appropriate);
Methods
- Evaluation measurement technique;
- error-proofing
- sample size and frequency
- control method
Customer specific requirements-If any
Specified reaction plan; when nonconforming product is detected, the process becomes statistically unstable or not statistically capable
Control plan is reviewed & updated for any of the followings
- If non conforming parts shipped to the customer
- Any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA)
- After a customer complaint and implementation of the associated corrective action, when applicable;
- After one year
- If required customer approval is taken after review or revision of the control plan

8.5.1.2 Standardized work — operator instructions and visual standards

XXX ensure that :

Standardized operating procedures/Instructions are communicated to the employee & training has been given to all SOP to enhance their understanding
SOP are printed in readable Font size & fax printing boards are displayed for general instructions
Instructions are presented in Hindi/English/sketch form, which are understood by the responsible personnel
SOP/Instructions are displayed at the work place
Safety boards are displayed on the shop floor

8.5.1.3 Verification of job set-ups

Verification of job setup/First off is done for the followings:

Initial run of the job
Material change over
Every morning at the time of start the machine
Start the machine after un planned breakdown of the machine
Start the production after planned / un planned plant shutdown
First piece approval record is retained

8.5.1.4 Verification after shutdown

Verification of job setup/First off is done to ensure product compliance with requirements after planned / Unplanned plant shutdown

Reference- Documented process for validation of process

8.5.1.5 Total productive maintenance

Total predictive maintenance includes the followings

List of necessary machines is made to produce conforming product at the required volume
Minimum stock level of Critical spares are maintained for key machines
Hand grinders, Lathe Machines & Welding sets are available for maintenance
Tooling/gauges are preserved & stored in racks & almirah
Customer specific requirements –if any
Maintenance objectives- Machine maintenance hours, MTTR,MTBF& OEE
Performance of the Maintenance objectives are reviewed in management review
Monitoring of the P.M plan & objectives are done on monthly basis and corrective actions are initiated where objectives are not achieved
Preventive maintenance of every machine is carried out as per plan
Predictive maintenance is done by periodic or continuous monitoring of the equipment condition through hearing, touching, smelling and observing, in order to predict when maintenance is required
Periodic overhaul is done based on fault or interruption history, machine is proactively taken out of service and disassembled, repaired, parts replaced, reassembled, and then returned to service

Reference- Documented process for maintenance

8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment

XXX provide resources for tool and gauge design, fabrication, and verification activities for production and service materials and for bulk materials, as applicable. XXX establish and implement a system for production tooling management, whether owned by XXX or the customer, including:
a) maintenance and repair facilities and personnel;
b) storage and recovery;
c) setup;
d) tool-change programmes for perishable tools;
e) tool design modification documentation, including engineering change level of the product;

f) tool modification and revision to documentation;
g) tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership; and location.
XXX verify that customer-owned tools, manufacturing equipment, and test inspection equipment are permanently marked in a visible location so that the ownership and application of each item can be determined. XXX implement a system to monitor these activities if any work is outsourced.

Solid Works, Auto CAD and 3D Printing for Tool design & calculating the weight & detail work
VMC,Lathe, shaper, Milling, Grinders, & Drill machines are provided for fabrication the tools
Production tooling management includes the followings
- Lathe, shaper, Milling, Grinders & Drill machines are used for maintenance & repair of tools
- Responsibility of the tool design & maintenance are covered in responsibility & authority matrix-Annexure-02
- Storage of the tools are stored in racks
- First pcs are inspected for dies at the time of setup
- Tool change programme for perishable tools (punches) as mentioned in control plan
- Tool change modification is done if required against Engineering change/Process change & same is mentioned in the Engineering change/Process change note
- Tool history card is updated after amendment in tools
- Tool identification is done through serial number and list of dies is maintained for the same
Customer-owned tools, manufacturing equipment, and test/inspection equipment are permanently marked (if provided)
At present Heat Treatment of the tools are done outsourced and above mentioned activities are monitored through supplier visit&verifying the supplier’s test certificate.

Reference- Documented process for Tool Room

8.5.1.7 Production scheduling

XXX ensure that production is scheduled in order to meet customer orders/demands such as Just- ln-Time (JlT) and is supported by an information system that permits access to production information at key stages of the process and is order driven. XXX include relevant planning information during production scheduling, e.g., customer orders, supplier on time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, preventive maintenance, and calibration. XXX ensure

Product schedule is done as per the customer’s order
Work order is issued to the HOD production in line with the customer’s schedule
HOD production plans the production as per availability of the machine, manpower & tools
Daily production report is maintained, that permits access to production information at key stages of the process and is order driven
Following information includes during production schedule
- Customer’s required delivery date
- Availability of the raw material & supplier delivery performance
- Availability of machine & Capacity
- Lead time/cycle time
- Inventory level
- Preventive maintenance plan & calibration plan

Reference- Documented process for Production

8.5.2 Identification and traceability

XXX. has identified all products by suitable means (i.e. tags, markings, labels, supplier/customer markings) throughout the product realization process. XXX identifies the product status with respect to monitoring and measurement requirements via labels, tags, inspection stamps, and/or associated quality records. Products whose identification and inspection status cannot be verified will be handled in accordance with the Control of Nonconforming Product .When traceability is a specified customer and/or industry requirement, XXX will control the unique identification of the product and maintain records (i.e. traceability via the Lot Numbers documented on the labels for each product).

8.5.2.1 Identification and traceability — supplemental

The purpose of traceability is to support identification of clear start and stop points for product received by the customer or in the field that may contain quality and/or safety-related nonconformities. Therefore, XXX shall implement identification and traceability processes as described below. XXX conduct an analysis of internal, customer, and regulatory traceability requirements for all automotive products, including developing and documenting traceability plans, based on the levels of risk or failure severity for employees, customers, and consumers. These plans shall define the appropriate traceability systems, processes, and methods by product, process, and manufacturing location that:

a) enable XXX to identify nonconforming and/or suspect product;
b) enable XXX to segregate nonconforming and/or suspect product;
c) ensure the ability to meet the customer and/or regulatory response time requirements;
d) ensure documented information is retained in the format (electronic, hardcopy, archive) that enables XXX to meet the response time requirements;
e) ensure serialized identification of individual products, if specified by the customer or regulatory standards;
f) ensure the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics.

Reference- Documented process for identification & traceability

8.5.3 Property belonging to customers or external providers

Specific requirements for communicating customer property issues will be established at the Quotation Phase and conveyed to the Quality and Manufacturing Departments, as applicable. While under XXX’s control, the customer property will be identified, verified, protected and safeguarded as if it were actually owned by XXX

Property belongs to customer or external providers are as follows

S.No.	Property belonging to	Property	Controls
1	Customer	Drawings& Samples	Identified though External document stampStored in filesList of drawing is made.Distributions of drawing are controlled, protected and safeguard
4	External Providers	Nil	NA

Customer owned packaging, dies, fixtures and/or equipment provided by the customer will be permanently marked so that the ownership of each item is visible and apparent. When the property is lost, damaged or otherwise found to be unsuitable for use, the organization reports this to concern personal through mail and retain this information

8.5.4 Preservation

XXX will preserve the product during internal processing and delivery to intended destination in order to maintain conformity to requirements. As applicable, preservation will include identification, handling, packaging, storage and protection. Preservation will also be applied to constituent parts of the product. Unless specified by contract, XXX’s policy is that the protection of the quality of the product ceases once the product is loaded onto the delivery vehicle and signed for by the transportation service . If required by customer, the responsibility for the quality of product may be extended to include delivery to destination. As business practices dictate, XXX will assist in the investigation of any customer claims resulting from possible subcontractor transit damage. XXX ensure that

Products are stored in racks/Bins & movement is done through trollies
Rustproof oil is applied on the material where ever is required by the customer to preserve the material
Identification of the material is done though tags (Green, Yellow & Red)
Packing is done in corrugated box/Jute bags/Plastic bags are the customer’s requirements

8.5.4.1 Preservation — supplemental

Preservation apply to materials and components from external and/or internal providers from receipt through processing, including shipment and until delivery to acceptance by the customer’ in order to detect deterioration, XXX assess at appropriate planned intervals the condition of product in stock, the place/type of storage container, and the storage environment. XXX use an inventory management system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out’ (FIFO). XXX ensure that obsolete product is controlled in a manner similar to that of nonconforming product. Organizations shall comply with preservation, packaging, shipping, and labeling requirements as provided by their customers. XXX ensures that

Stock is assess once in a year in the month of March to detect the deterioration
FIFO is maintained through date of receiving & heat number. FIFO board is displayed & maintained to monitor the stock rotation for raw material
Obsoleted products are identified with red tags & stored separately
Labeling contains the following information- Customer’s Name, Part Name, Drawing Number, Number of pcs

Reference- Documented process for Handling, storage, preservation & issue of material

8.5.5 Post-delivery activities

Products are replaced/reworked free of cost, if found any manufacturing defects at the time of receiving inspection at customer end.

8.5.5.1 Feedback of information from service

Communication is done through email for any customer concerns related to manufacturing, material handling and logistics. If any product is found defective at customer end due to manufacturing/handling then minor rework is done at the customer end otherwise material is returned back by the customer & rework is done in house

8.5.5.2 Service agreement with customer

At present there is no service agreement with the customer. However, in future if there is any, the same will be considered accordingly.

8.5.6 Control of changes

Xxx reviews and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. Xxx is to retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review

8.5.6.1 Control of changes — supplemental

XXX have a documented process to control and react to changes that impact product realization. The effects of any change. including those changes caused by XXX, the customer, or any supplier, are assessed.
XXX:
a) define verification and validation activities to ensure compliance with customer requirements;
b) validate changes before implementation;
c) document the evidence of related risk analysis;
d) retain records of verification and validation.
Changes, including those made at suppliers, should require a production trial run for verification of changes (such as changes to part design, manufacturing location, or manufacturing process) to validate the impact of any changes on the manufacturing process. When required by the customer, XXX shall:
e) notify the customer of any planned product realization changes after the most recent product approval;
f) obtain documented approval, prior to implementation of the change;
g) complete additional verification or identification requirements, such as production trial run and new product validation.

Ref-Documented process of ECN

8.5.6.1 Temporary change of process controls

XXX identify, document, and maintain a list of the process controls, including inspection, measuring, test, and error-proofing devices, that includes the primary process control and the approved back-up or alternate methods. XXX document the process that manages the use of alternate control methods. XXX include in this process, based on risk analysis (such as FMEA), severity, and the internal approvals to be obtained prior to production implementation of the alternate control method.
Before shipping product that was inspected or tested using the alternate method, if required, XXX shall obtain approval from the customer(s). XXX maintain and periodically review a list of approved alternate process control methods that are referenced in the control plan. Standard work instructions are available for each alternate process control method. XXX review the operation of alternate process controls 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. Example methods include but are not limited to the following:
a) daily quality focused audits (e.g., layered process audits, as applicable);
b) daily leadership meetings.
Restart verification is documented for a defined period based on severity and confirmation that all features of the error-proofing device or process are effectively reinstated.
XXX implement traceability of all product produced while any alternate process control devices or processes are being used (e.9., verification and retention of first piece and last piece from every shift).

Ref-Documented process – manages the use of alternate control methods

8.6 Release of products and services

Incoming, In-process and Final inspection is carried out to verify that the product and services requirements have been met. Release of product does not proceed to the customer until satisfactory completion of final inspection, unless otherwise approved by Director or customer. The organization retains the Final Inspection report on the release of products. Final inspection report includes

Evidence of conformity with the control plan / customer’s drawing/specification
HOD QA is authorized to release the product

Ref-Documented process in process & Final inspection report

8.6.1 Release of products and services — supplemental

XXX ensure that the planned arrangements to verify that the product and service requirements have been met encompass the control plan and are documented as specified in the control plan. XXX ensure that the planned arrangements for initial release of products and services encompass product or service approval. XXX ensure that product or service approval is accomplished after changes following initial release. NPD ensures that all product & process requirements for new product as well as changes have been incorporated & documented in the control plan through checking & reviewing by the competent person. Initial release of product is done through first piece approval

Ref-Documented process in process & Final inspection report

8.6.2 Layout inspection and functional testing

A layout inspection is carrying out once in three months/unless otherwise specified by customer for complete measurement of all product as per customer supplied drawing.
If any dimension couldn’t check in house such as thread load test & parameters related to CMM are checked by outside NABL accredited lab.
Layout inspection records are available for customer review

Ref-Documented process Layout inspection

8.6.3 Appearance items

For organizations manufacturing parts designated by the customer as “appearance items,” XXX shall provide the following:

appropriate resources, including lighting, for evaluation.Sufficient lights, limit samples are provided to verify the following appearance parameters as mentioned in the drawings.
masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOl)’ and
maintenance and control of appearance masters and evaluation equipment.
verification that personnel making appearance evaluations are competent and qualified to do so.
Scratches, cracks, dents, burrs, un-filling, blowholes, finish etc. Limit samples / photographs are displayed at the work place.
Competency & Qualification of the personnel making appearance evaluation is verified through visual inspection test

Ref- Attribute MSA

8.6.4 Verification and acceptance of conformity of externally provided products and services

Following methods are used to ensure the quality of externally provided processes/product Review of pre-dispatch inspection report/ Material test report provided by the supplier

Receiving inspection as per control plan
Testing of the material through outside accredited lab
Product/Process audit at supplier site

8.6.5 Statutory and regulatory conformity

Prior to release of externally provided products into its production flow, XXX confirms and provides evidence that externally provided processes, products, and services conform to the latest applicable statutory, regulatory, and other requirements in the countries where they are manufactured and in the customer-identified countries of destination, if provided. Followings requirements are verified for Statutory & regulatory compliance,prior to release the externally provided product in to the production flow

Material test certificate for ROHS compliance – if required by customer
MSDS for hazardous & toxic chemicals used in testing/production- if any

8.6.6 Acceptance criteria

Acceptance criteria are defined in the control plan and submitted to the customer for approval during PPAP approval. Acceptance level is zero defects for attribute data sampling.

8.7 Control of nonconforming outputs

Nonconforming products are identified through Red tags and kept separate to prevent unintended use or delivery. Following actions are taken care based on the nature of nonconformity and its effect on the conformity of product

Segregation of the product
Return to supplier for rework (if BOP/Outsourced)
Alteration for in house defects
Inform to the customer if non conforming products are detected after the delivery
Obtaining authorization for acceptance under concession by the Director if required
Re verification of the requirements after correcting the non conformities

Ref-Documented Process for Control of Non conforming Product

8.7.1.1 Customer authorization for concession

Director obtains the customer concession or deviation prior to further processing for “use as is” & for repair of nonconforming product/subcomponents, which is different from the currently approved. HOD Q.A maintains the record of expiry date for authorized quantity. HOD Q.A ensures compliance with the original or superseding specifications when the authorization expires. Material dispatched under concession is promptly identified on each packing box and informed to the customer through mail. The above requirements are also applicable to the purchased product.

8.7.1.2 Control of nonconforming product — customer-specified process

HOD QA ensures the compliance with Customer specific controls for nonconforming product(s).

8.7.1.3 Control of suspect product

Product with unidentified or suspect status is classified as a nonconforming product. Training for containment of suspect and non-conforming product is provided to the concerned personal

8.7.1.4 Control of reworked product

XXX utilize risk analysis (such as FMEA) methodology to assess risks in the rework process prior to a decision to rework the product. lf required by the customer, XXX shall obtain approval from the customer prior to commencing rework of the product. XXX have a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications. instructions for disassembly or rework, including re-inspection and traceability requirements, are accessible to and utilized by the appropriate personnel. XXX retain documented information on the disposition of reworked product including quantity, disposition, disposition date, and applicable traceability information.

Ref-Documented Process for Control of Non conforming Product

8.7.1.5 Control of repaired product

XXX utilize risk analysis (such as FMEA) methodology to assess risks in the repair process prior to a decision to repair the product. XXX obtain approval from the customer before commencing repair of the product. XXX have a documented process for repair confirmation in accordance with the control plan or other relevant documented information. Instructions for disassembly or repair, including re-inspection and traceability requirements, is accessible to and utilized by the appropriate personnel. XXX obtain a documented customer authorization for concession for the product to be repaired. XXX retain documented information on the disposition of repaired product including quantity, disposition, disposition date, and applicable traceability information.

Ref-Documented Process for Control of Non conforming Product

8.7.1.6 Customer notification

Customer is informed immediately by phone/email in the event that nonconforming product is shipped
Internal communication is done through meeting and raised internal NC & initiate corrective action for the same

8.7.1.7 Nonconforming product disposition

Non-conforming, Deviation & corrective action report is retained for rejection & rework that describes the below points

Daily/Monthly Non-conforming report

Part Name & Process Name
Qty inspected /produced
Rejection & Rework quantity
Nature& Qty of defects

Deviation report

Part Name & Process Name
Defect observed
Description of the concession
Authorized Qty /time period
Authorized person

Corrective action report

Part Name & Process Name
Nature of defects
Correction, Root cause & Corrective action
HOD Q.A with the help of CFT decides the action for non-conforming products

Ref-Documented Process for Control of Non conforming Product

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

S.No.	What to be Monitored & measured	Method of Monitoring, measurement, analysis & evaluation	Frequency of Monitoring & measurement,	Analysis & evaluation frequency	Documented information
1	Customer satisfaction	Customer satisfaction survey	Once in a year	Six Months during management review	Customer satisfaction assessment form & Minutes of management
2	Rejection in products	Variable & Attribute inspection through out the product realization	When ever occurred	Monthly	Rejection report
3	Rework in products	Variable & Attribute inspection through out the product realization	When ever occurred	Monthly	Rework report
4	Performance of external providers	Performance monitoring through quality & delivery marks	Monthly	Six Months during management review	External provider performance monitoring sheet
5	Machine Breakdown	Monitor the start time & end time of breakdown, spares used, correction, root cause & corrective action	When ever occurred	Monthly	Breakdown Maintenance record
6	Customer complaints	Receive the complaints through email/verbal mode and analysis the problem through root cause analysis and take correction & corrective action for the same	When ever occurred	Monthly	Customer complaint record sheet
7	Performance & effectiveness of the QMS	Achievement of the objectives (sale target, COPQ, Rejection, Rework, Productivity, MTTR, MTBF, Quenching oil consumption, Delivery etc.	Monthly	Six Months during management review	Objective sheet
8	Effectiveness of action taken to address risk & opportunity	Process wise monitoring of Risk, Probability, impact, exposure, mitigation & contingency	Yearly	Six Months during management review	Internal, External issues & Risk assessment sheet

9.1.1.1 Monitoring and measurement of manufacturing processes

Initial process study is carried out on all new manufacturing process to verify process capability and to provide additional input for process control for special characteristics. Manufacturing process capability are carried out as per AIAG reference manual or specified by customer (if any). Process audit & product audit is carried out to verify the followings:

PFD, PFMEA & Control plans are implemented
Adherence to the measurement techniques
Adherence to the sampling plan
Adherence to the acceptance criteria
In-process inspection as per plan
Adherence to reaction plan and escalation process when acceptance criteria are not met

Significant process events, such as tool change or machine repair are recorded in the run chart/in-process inspection report. Reaction plan includes the 100% inspection for characteristics that are either not statistically capable or are unstable. Corrective action is developed & implemented to ensure that the process becomes stable and statistically capable. Plans is reviewed with and approved by the customer, when required. Effective dates of process changes are maintained in the process change record sheet

9.1.1.2 Identification of statistical tools

XXX determine the appropriate use of statistical tools. XXX verify that appropriate statistical tools are included as part of the advanced product quality planning (or equivalent) process and included in the design risk analysis (such as DFMEA) (where applicable), the process risk analysis (such as PFMEA), and the control plan. Statistical tools such as Control charts (X-bar & R chart), Run chart,Cp/Cpk, Pp/Ppk are determined and includes as part of APQP and includes in the PFMEA & Control plan

9.1.1.3 Application of statistical concepts

Statistical concepts, such as variation, control (stability), process capability, and the consequences of over-adjustment, is understood and used by employees involved in the collection, analysis, and management of statistical data. Basic statistical concept such as Control charts (X-bar & R chart), Run chart, Cp/Cpk, Pp/Ppk, R&R &Kappa are understood and implemented through out the organization by trained personnel such as Engineer Quality/ Production.

9.1.2 Customer satisfaction

Xxx is to monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. Xxx is determined the methods for obtaining, monitoring, and reviewing this information. The Quality In Charge has primary responsibility for Customer Satisfaction as one of the measurements of the Quality Management System and as to whether the organization has met customer requirements. Customer satisfaction shall include the collection of authentic data, frequency, and validity of the analysis. The trend and major elements affecting customer satisfaction and key indicators of customer dissatisfaction will be monitored supported by objective evidence. Wherever data available, the level of customer satisfaction will be compared with those of our competitors & a relevant action plan will be evolved. A customer satisfaction analysis survey will be conducted ONCE IN A 12 MONTHS Review of customer satisfaction will be taken by top management during Management Review Meeting as described in Procedure.

9.1.2.1 Customer satisfaction — supplemental

Following methods are used to monitor& review the Customer’s satisfaction

Customer satisfaction survey once in a year for the followings- Delivery, Quality, Response of enquiries & complaints, Efforts for new product development, line stoppage, field returns, warranty failures.
Customer’s score card/rating available on the portal or mailed by the customer (if provided)
Followings Internal & external performance indicators based on objective evidences
- Delivered part quality performance
- Customer disruptions
- Field returns, recalls, and warranty (where applicable)
- Delivery schedule performance (including incidents of premium freight);
- Customer notifications related to quality or delivery issues, including special status.

Reference- Documented process for monitoring customer satisfaction

9.1.3 Analysis and evaluation

HOD Q.A & Manager system analyzes and evaluates data and information arising from monitoring and measurement and result of analysis is used to evaluate the followings

Customer satisfaction.
In house rejection/rework
Poor quality cost
Productivity
Customer returns
Breakdown Hours
Customer complaint
On time dispatch
External provider delivery/ quality performance
Effectiveness of action taken to address risk & opportunity
Performance, effectiveness & need for improvement to the QMS

9.1.3.1 Prioritization

Trends in quality and operational performance are compared with progress toward objectives and lead to action to support prioritization of actions for improving customer satisfaction.

9.2 Internal audit

Procedures are established for a system of planned and documented internal quality audits to verify that the Quality Management System conforms to the planned arrangements as per IIATF 16949:2016 requirements and effectively implemented and maintained.

The MR is responsible for:

Planning and organizing audits at works depending on the importance and the extent of the activity concerned and the results of the previous audits. The internal quality system audits as per schedule are to be carried out at least once in SIX Months period and at least 02 times during a year.
MR also ensures that the trained auditors are involved in quality system audit to ensure the objectivity of the auditing processes and are not directly responsible for the area under audit. The results of the audit are documented in the specified format to record non-conformances in product/process and work practices and brought to the notice of the person responsible for the area audited, who in turn shall take appropriate corrective actions within the agreed time limit and ensure removal of deficiencies observed. Follow up on the effectiveness of the corrective action taken.
The effectiveness of identified corrective action against any such internal audit findings is verified by the MR prior to subsequent management review meetings and recorded.
MR is responsible for ensuring that non-conformances observed during IA are closed by appropriate corrective action implementation in a defined period.MR identifies and marks the corrective actions needing confirmation for their effective implementation and also arranges for the verification in subsequent audits or follow-up audits will be planned.
MR maintains appropriate records of implementation & effectiveness in the form of internal audit reports. The details of the audit team, schedule, preparation of non-conformances reports,
The follow up on the corrective actions is detailed in the procedure for corrective action
The nonconformance identified during third-party audits or by external agencies is handled in the same manner. The non-conformances of IA remaining open due to a delay in the implementation of corrective action along with major non-conformances recorded will be reviewed during management review meetings.

9.2.2.1 internal audit programme

XXX have a documented internal audit process. The process includes the development and implementation of an internal audit programme that covers the entire quality management system including quality management system audits, manufacturing process audits, and product audits. The audit programme is prioritized based upon risk, internal and external performance trends, and criticality of the process(es). Where XXX is responsible for software development, XXX include software development capability assessments in their internal audit programme. The frequency of audits is reviewed and, where appropriate, adjusted based on occurrence of process changes, internal and external nonconformities, and/or customer complaints. The effectiveness of the audit programme is reviewed as a part of management review.

9.2.2.2 Quality management system audit

XXX audit all quality management system processes over each three-year calendar period, according to an annual programme, using the process approach to verify compliance with this Automotive QMS Standard. integrated with these audits, XXX sample customer-specific quality management system requirements for effective implementation.

9.2.2.3 Manufacturing process audit

XXX audit all manufacturing processes over each three-year calendar period to determine their effectiveness and efficiency using customer-specific required approaches for process audits. Where not defined by the customer, XXX shall determine the approach to be used. Within each individual audit plan, each manufacturing process is audited on all shifts where it occurs, including the appropriate sampling of the shift handover. The manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan, and associated documents.

9.2.2.4 Product audit

XXX audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements. Where not defined by the customer, XXX shall define the approach to be used.

Ref-Documented Process Internal audit

9.3 Management review

9.3.1 General

QMS is reviewed once in six months to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.Top management of Xxx is reviewing the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. Management review will be conducted and chaired by MD once in SIX Months to ensure continuing suitability & effectiveness in satisfying the requirements of IATF 16949:2016 and the stated quality policy and objectives. The Management Review will include all elements of the entire quality system as detailed in the procedure and schedule for the Management Review. Records of Management Review Meetings shall be maintained by MR. The Director during review shall assess opportunities for improvement and the need for changes in the Quality Management System, including the Quality Policy and Quality Objectives.

9.3.1.1 Management review — supplemental

Top management review the organization’s QMS once in six months.The frequency of management review(s) is increased based on risk to compliance with customer requirements resulting from internal or external changes impacting the quality management system and performance-related issues.

9.3.2 Management review inputs & 9.3.2.1

The management review is planned and carried out taking into consideration

The status of actions from previous management reviews
Changes in external and internal issues that are relevant to the quality management system;
Information on the performance and effectiveness of the quality management system, including trends in:
- customer satisfaction and feedback from relevant interested parties;
- the extent to which quality objectives have been met;
- process performance and conformity of products and services;
- nonconformities and corrective actions;
- monitoring and measurement results;
- audit results;
- the performance of external providers
The adequacy of resources;
The effectiveness of actions taken to address risks and opportunities;
Opportunities for improvement

9.3.2-1 Management review inputs – supplemental

The management review is planned & carried out taking into consideration

Cost of poor quality
Process effectiveness & efficiency for product realization processes,
Product conformance
Assessment of manufacturing feasibility made for changes to existing operations & for new facilities or new products
Review of performance against maintenance objectives
Review of customer scorecard
Identification of potential field failure
Actual field failure & their impact on safety/environment.
Summary results of measurements at specified stages during the design and development of products and processes. (Measurements may consider, for example: timing, costs, or feasibility)

9.3.3 Management review outputs

The outputs of the management review includes decisions and actions related to

Opportunity for improvement
Any need for changes to the quality management system
Resources needs
Action plan when customer performance targets are not met.

9.3.3.1 Management review outputs – supplemental

Top management shall document and implement an action plan when customer performance targets are not met.

Ref-Documented Process Internal audit

10. Improvement

10.1 General

Once the processes are capable and stable then CFT determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction that includes the followings

Improvement in products and processes to meet requirements as well as to address future needs and expectations;
Correcting, preventing or reducing undesired effects such as Rejection/ Rework / COPQ /Complaints/Unplanned breakdowns etc.
Improving the performance and effectiveness of the quality management system through using the following tools
- Cause & effect diagram
- Flow chart
- Histogram
- Control charts
- Check sheets
- Internal audits
- Management review outputs

10.2 Nonconformity and corrective action

10.2.1 The functional head collects the information related to the nonconformity from the followings

Customer complaint/ return/ feedback
In house rejection/rework
Internal audit non conformities
External audit (third party) non conformities
Customer’s audit non conformities
Supplier’s rejection

When above non-conformities occurs, the followings actions are taken

Nonconformities related to customer complaint/ return logged in customer complaint register, in house rejection/rework in nonconformity register, internal/external/customer audit finding in corrective action request form.
Functional head review the nature of nonconformity, identify the correction, consequences & root cause with the help of cause and effect diagram, why-why analysis and suggest the corrective action to eliminate the cause of detected nonconformity.
Functional head ensures that corrective action gets implemented in the affected area.
Director reviews and verifies the effectiveness of the corrective action taken.
Corrective action & its effectiveness is recorded in the corrective action report or incase of customer complaint in the customer prescribed format if any and made available upon request to customer.
Update risk & opportunities determined during planning as necessary
Make changes to the QMS- such as PFD, PFEA, CP, QM, SOP etc. if necessary
If corrective action effectively implemented then HOD Q.A apply it to the similar processes.

10.2.2 Corrective action report is retained which contains the followings

Nature of non conformities
Correction
Root cause
Corrective action
Horizontal deployment
Change in the QMS
Effectiveness of the corrective action

10.2.3 Problem solving

XXX have a documented process(es) for problem solving including:
a)defined approaches for various types and scale of problems (e.g., new product development, current manufacturing issues, field failures, audit findings);
b) containment, interim actions, and related activities necessary for control of nonconforming outputs
c) root cause analysis, methodology used, analysis, and results;
d) implementation of systemic corrective actions, including consideration of the impact on similar processes and products:
e) verification of the effectiveness of implemented corrective actions;
f) reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, control plan). where the customer has specific prescribed processes, tools, or systems for problem solving, XXX uses those processes, tools, or systems unless otherwise approved by the-customer.

Ref-Documented Process for corrective action (Problem solving)

10.2.4 Error-proofing

XXX have a documented process to determine the use of appropriate error-proofing methodologies. Details of the method used is documented in the process risk analysis is such as PFMEA) and test frequencies are documented in the control plan. The process shall include the testing of error-proofing devices for failure or simulated failure. Records are maintained. Challenge parts, when used, is identified, controlled, verified, and calibrated where feasible. Error-proofing device failures shall have a reaction plan.

Ref-Documented Process corrective action (Error proofing)

10.2.5 Warranty management systems

When XXX is required to provide warranty for their product(s), XXX shall implement a warranty management process. XXX include in the process a method for warranty part analysis, including NTF (no trouble found). When specified by the customer, XXX shall implement the required warranty management process.

Reference- Documented process for Warranty Management

10.2.6 Customer complaints and field failure test analysis

CFT performs analysis on the parts rejected/complaints received from customer and initiate problem solving & corrective action with in target time given by customer.Records of this analysis is maintained and results are communicated to the customer & with in the organization. XXX perform analysis on customer complaints and field failures, including any returned parts, and initiate problem solving and corrective action to prevent recurrence. Where requested by the customer, this shall include analysis of the interaction of embedded software of XXX’s product within the system of the final customers product. XXX communicate the results of testing/analysis to the customer and also within XXX.

Reference- Documented process for customer complaint handling

10.3 Continual improvement

XXX continually improved the suitability, adequacy, and effectiveness of the quality management system. XXX considers the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of the continual improvement

10.3.1 Continual improvement – supplemental

XXX have a documented process for continual improvement. XXX include in this process the following:

identification of the methodology used, objectives, measurement, effectiveness, and documented information;
a manufacturing process improvement action plan with emphasis on the reduction of process variation and waste:
risk analysis (such as FMEA).

Ref-Documented Process Continual Improvement

Customer Specific Requirements							Annexure-07 Rev 01 dated -01.12.2020
IATF Requirements	Customer specific additional Requirements for TVS Motor ( ref. SQAM Supplier Quality Assurance Manual )	Customer specific additional Requirements for Multimatic	Customer specific additional Requirements for Jay Industries	Customer specific additional Requirements for Lander Automotives	Customer specific additional Requirements for Jost	Customer specific additional Requirements for Rockman Industries	Customer specific additional Requirements for Diado India	Process Name (Where this requirement is applicable)
4.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
4.2	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
4.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
4.4	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
5.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
5.2	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
5.3 Organizational roles, responsibilities and authorities	The supplier shall submit an organisation chart including the roles and responsibilities of each function and number of persons (Manager, Executives, and Inspectors) along with the contact information.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	HR
	The supplier shall notify TVSM of any changes in their contact information as and when they are made. Revised forms shall be sent within 7 days of such changes.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	HR
6.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
6.2	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
6.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
7.1.5.1.1 Measurement systems analysis	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Quality
	On an on going basis, the supplier shall conduct Gauge R&R (variable and attribute studies) on all types of measurement systems at least once in a year
	The types of measurement system shall be identified / grouped based on instrument type, instrument range and resolution, part characteristics, operating environment and skills / competences of personnel using the instrument.
7.2	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
7.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
7.4	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
7.5 Documented information	Retention period- 2 Years Inspection Standards, Inspection Reports, Tooling Maintenance Reports, Control Chart, Material Test Reports, Performance Test Reports, Calibration Records, Machine Capability Study Reports, Audit Reports, QUALITY DEVIATION HIGHLIGHTS, Action Plans, Kaizens, QC Story	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Control of documented information
7.5 Documented information	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Control of documented information
8.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.2.3.1.3 Organization manufacturing feasibility	Prepare Manufacturing Feasibility and Risk Analysis format QSF PUR SQAM 002,003 and drawing feedback & agreement form QSF PRG 02 01 018 and feedback / suggestions for QCD improvements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Marketing & Sale and New Product Development
	manufacturing feasibility as per checklist QSF PUR SQAM 003	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	Supplier shall use TVSM format QSF QAD 10 11 05 for preparation of AOI	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.3.2 Design and development planning	Readiness Review– This is done by reviewing product and process design documents as per checklist CL QAD 10 11 001	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	New Product Development
	IPTR (Initial Production Trial Run)– typically 50 nos. and reviewing the results as per checklist CL QAD 10 11 002	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	SPTR (Significant Production Trial Run)– (8 hours Production or 300 nos ) at planned run-at-rate and reviewing the results as per checklist CL QAD 10 11 003	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.3.3.3 Special characteristics	Safety / Statutory / regulatory- severity = 9 or 10. Minimum Process Performance index / process capability levels for variable characteristics 1.0 for geometric & 1.67 others	Follow as per Drawing	Follow as per Drawing	Follow as per Drawing	Follow as per Drawing	Follow as per Drawing	Follow as per Drawing	New Product Development
	Fit / Function – Critical- severity = 7 or 8. Minimum Process Performance index / process capability levels for variable characteristics 1.0 for geometric & 1.67 others
	Fit / Function – major- severity = 5 or 6. Minimum Process Performance index / process capability levels for variable characteristics 1.0 for geometric & 1.33 others
	Supplier shall send the of process capability reports on monthly basis for special characteristics, controlled through X-bar, R chart. Action plan to be submitted to improve the process capability, if Cpk is below the norms specified in the manual.							Quality & Production
8.3.4.4 Product approval process	Submit the PPAP documents through Collaboration Folder link available on http://www.tradewithtvs.com and Table 1 shows the 19 requirements for the PPAP submission	Pilot Lot of 300 nos along with PPAP Documents Material reports to be uploaded on IMDS If required	Intial 10 nos nos along with PPAP Documents	Intial 5 nos nos along with PPAP Documents Material reports to be uploaded on IMDS if required	Intial 05 nos nos along with PPAP Documents	Intial 10 nos nos along with PPAP Documents	Intial 10 nos nos along with PPAP Documents	New Product Development
8.3.5.2 Manufacturing process design output	FMEA shall follow the latest edition of FMEA reference manual published by AIAG	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	New Product Development
	High risk in FMEA is defined where severity is high and / or RPN is high for a failure mode / cause. High Severity ³ 7 or High RPN ³ 63 ( action plan required to reduce severity or RPN ).	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	special attention to be given for high severity rankings even if RPN is low. Whenever severity is 9 or 10 and no actions are possible to reduce severity ranking, efforts shall be taken to minimize occurrence and detection ranking.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.4 Control of externally provided processes, products and services	Maintain master list of all the T2 suppliers with clear details of the operations carried out and provide a copy to TVSM along with PPAP.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Purchase & Quality
	Carry out special processes like heat treatment, plating, painting, powder coating etc only at the mutually approved sources.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	TVSM may review the PFD, PFMEA & Control Plan of the Tier 2 supplier during part development if required.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.4.2.4.1 Second Party Audit	Supplier shall make a plan for Tier 2 audit covering all Tier2 suppliers.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Purchase, G.M Systems & Quality
8.4.2.4.1 Second Party Audit	Supplier shall verify following areas – Availability of latest revision of drawing and inspection standard – Adherence to Control Plan – Condition & Calibration of Gauges / Instruments / Tool / Equipments – Part parameter audit – Condition of jig / fixture / tools / gauges & history maintenance. – NC products identification and handling – Deployment of certified operators and inspectors in critical processes – If a special process is done by Tier 2, then the special process qualification to be verified and approval by TVSM. – Layout inspection, product audits. – Supplier may cover additional areas as required	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Purchase, G.M Systems & Quality
8.5.1 Control of production and service provision	Process Qualification Supplier shall identify the special processes ie (Heat treatment, Plating, Painting, Powder Coating, Welding, etc) and make a plan for conducting the process qualification, including Tier 2.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality, Production & Purchase
8.5.1 Control of production and service provision	The process shall be set at minimum condition for all process parameters as per the Control Plan and produce the product as per the normal batch size. (E.g. Temp: 160 ~ 200 deg Time: 5minutes ~ 8 minutes in a plating process then produce the batch by setting temp at 160 deg and time 5 minutes for minimum condition)	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality, Production & Purchase
8.5.2.1 Identification & Traceability	Batch Number Supplier Identification LH / RH designation Date of manufacture, Month, Year Cavity no, Mould no, Die no, Date Code / Heat Code	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Production, New Product Development & Tool Management
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment	Issue Tool Ownership Certificate (QSF PUR SQAM 017) to TVSM, once the tools are proved.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Tool Management
	Review the condition of tool when quantity produced reaches 75 % of the agreed life. Thereafter, review the tool condition at incremental 10% production of the agreed tool life quantity	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Tool Management
8.5.6.1 Control of changes	Supplier shall submit request for engineering changes – format no. QSF PUR SQAM 014, process changes format no, QSF PUR SQAM 013 and obtain necessary clearance from TVSM for going ahead with the change implementation.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NPD
8.6	No additional requirements	Material TC and Inspection report with each every dispatch	Material TC and Inspection report with each every dispatch	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
8.7.1.1 Customer authorization for concession	Non-conformance of Minor in nature If the non conformance is minor in nature and if the supplier feels that it will not affect either the subsequent process at TVSM or the intended functional requirements at TVSM customer’s end, then they shall request TVSM for clearance thro, Deviation Approval Request format (QSF PUR SQAM 007) immediately and explain the non conformance nature.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality
8.7.1.1 Customer authorization for concession	The suppliers are notified through Quality Deviation Highlights (QDH) on Web http://www.tradewithtvs.com, the supplier shall ensure corrective actions on receipt of QDH and communicate the causes of failure. QDH raised for non-conformance shall be replied within 24 hours through E-Mail, Fax, Courier, or in person.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.7.1.6 Customer notification	Non-conforming parts shipped to TVSM and suppler end Supplier shall send Notification of Suspected Shipment of Non-confirming Product format (QSF PUR SQAM 006) to TVSM Purchase / Quality	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality
9.1.1.1 Monitoring and measurement of manufacturing processes	SPC shall be in line with latest edition of AIAG manual	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality & Production
	Process capability studies shall be carried out over a sample size of minimum 100 nos. (25 subgroups of 4 samples each or 20 subgroups of 5 samples each)	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	If the process becomes unstable or non-capable (as per table), supplier shall introduce 100% inspection for the parameter, till the Corrective Action is taken and normalcy restored.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	Supplier shall send the of process capability reports on monthly basis for special characteristics, controlled through X-bar, R chart. Action plan to be submitted to improve the process capability, if Cpk is below the norms specified in the manual.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
9.1.2.1 Customer satisfaction	Quality performance report for each supplier is published on the website http://www.tradewithtvs.com. Quality rating is arrived based on the quality performance covering lot, line rejections, and warranty returns including spare parts supply. If rating is less than 90%, supplier shall forward the action plans proposed / planned along with the time frame to meet the target, the progress of which shall be reviewed by the supplier management on monthly basis and to be presented to TVSM on demand.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality, Marketing & Sale
9.2.2.4 Product Audit	Supplier shall perform product audit for ready for despatch parts, to confirm dimensions against standard, Functionality, Packaging, Labeling, etc	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Purchase & Quality
9.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
10.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
10.2.5 Warranty management systems	Analyze the failure, using warranty analysis guidelines and warranty analysis summary format QSF PUR SQAM 010 & QSF PUR SQAM 011. It is recommended to check 50 – 100 nos of failed parts randomly and verify the following observations. – Phenomena of failure, kms etc – Location of failure – Bench mark study to identify the improvements – Simulation of field failure in lab – Identify the root cause of failure – Identify the counter measure – Compare the improvement in lab testing (before & after) – Implement the action with time plan format – Monitor the results	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality, Marketing & Sale
10.2.5 Warranty management systems	The implemented corrective action score shall be minimum 4 Detection type Poka Yoke • Design improvement (Sev 5 to 7) • Process improvement (Cpk 1.33 to1.67) • 100% additional test station • Automation of tool change frequency – visual control	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality
10.2.6 Customer complaints and field failure test analysis	Upon the receipt of complaint (Email / Fax / Quality Deviation Highlights), supplier representative shall visit TVSM to understand the problem within 24 hours.	Corrective action required to submit on DMN Portal	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality
	M1 action – Immediate action to be taken on stocks at TVSM- Quarantining / segregation / 100% inspection etc. Target lead time for completion of M1 action -Within 24 hrs
	M2 action -Temporary action to be taken at all stages of manufacturing, transit and storage through out the supply chain. to prevent the defect reaching TVSM.Example of means used –100% inspection / switch over from sampling to 100% inspection / Gauge introduction, etc Target lead-time for completion of M2 action – Within 48 hrs
	M3 action – Corrective action through problem solving approach (QC Story/Kaizen sheet/8D- report ) Target lead-time for( i) Submission of corrective action reports –within 7 days (ii) completion of M3 action – Within 15 days (according to the nature of problem and resolution)
10.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA

KPI of All DEPARTMENT
Dept Name	Indicator(s)	Units	Target	Monthly Observation ( July 22 to March 23)									Average
Dept Name	Indicator(s)	Units	Target	Jul-22	Aug-22	Sep-22	Oct-22	Nov-22	Dec-22	Jan-23	Feb-23	Mar-23	Average
Dispatch	Dispatch Planned Vs Actual	%	100%	76	85	90	70	89	90	88	85	97	86
Dispatch	Delivery Performances	%	100%	76	85	93	83	82	88	88	93	98	87
Engg	Timely development of new product as per Timing plan /Target given by the Customer	%	100	100	100	100	100	100	100	100	100	100	100
	First Time Approval	100%	100	100	100		99	99			99		99
	Discrepancy in PPAP Documents	Not Allowed	0	0	0	0	0	0	0	0	0	0	0
	Timely implementation of engineering change	Days	5	5	5	0	5	5	0	5	5	0	3
	No.of Customer complaints against PFMEA	Nos	0	0	0	0	0	0	0	0	0	0	0
	Modification of documents (PFMEA,CONTROL PLAN,WI,IS, O.S. etc).	Days
	Number of Projects Completed as plan	%
	Increase in Productivity	%
	Reduction in process Cost	Rs
	Reduction in Cycle Time Through reduced Material Movement	Sec
	Nos of Alternative method use	Nos
	CPK >1.67	Nos
HR	No. of Training programmes planned Vs Actually conducted	%	100	100	100	100	100	100	100	100	100	100	100
	Evaluation of Training Effectiveness	%	100	100	100	100	100	100	100	100	100	100	100
	Absenteeism Rate	%	10%	10	9	8	9	9	8	8	9	8	9
	One Suggestion/kaizen per employee	Nos
	Employee turnover ratio	%
LAB	No. of times discrepancy observed in test results	Nos	0	0	0	0	0	0	0	0	0	0	0
	Planned schedule Vs Actual calibration	%	100	100	100	100	100	100	100	100	100	100	100
	No. of times uncalibrated instruments found during the audits	Nos	0	0	0	0	0	0	0	0	0	0	0
	Layout Inspection Planned Vs Actual	%	100	100	100	100	100	100	100	100	100	100	100
	No. of parts inspected Vs parts accepted	%	100	100	100	100	100	100	100	100	100	100	100
	Required Testing time Carried Out	Hour
MAINT	Machine down Time due to Breakdown	Hrs	1000	841.7	277.4	216	249	236.28	224.5	204	205	204.83	295
	Mean time to repair (MTTR)	Hours	10	14.51	5.67	3.3	7.7	11.58	9.25	6.1	7.39	3.06	8
	Cost of Break Down	Rs	50000	343666	113595	187258	328264	144744	293877	294608	407476	318210	270189
	Mean Time Between Failure (MTBF)	Hours	10	12	15	18.0	10.0	12.0	17	12.0	15	16	14
	Preventive Maint.Planned vs Achievement	%
MS	No of repetitive NC	Nos	0	14	0	0	7	0	0	0	17	0	4
	No. of times wrong / manipulated records found during internal /External Quality Audit	Nos	0	0	0	0	0	0	0	0	0	0	0
	No of problem received Vs CAPA Implemented /Month	%	100	100	100	100	100	100	100	100	100	100	100
	Uncontrolled copies of documents found during audit	Nos	0	0	0	0	0	0	0	0	0	0	0
	Obsolete Documents found during audit	Nos	0	0	0	0	0	0	0	0	0	0	0
	Audit Planned Vs Actual	%	100	100	100	100	100	100	100	100	100	100	100
	Projects taken Vs implemented	Nos
	No of Improvements /Quarter	Nos
Prod	Production Plan Vs Achieved	%	100	76	85	90	70	89	90	88	85	97	86
	Cost of Poor Quality	RS	50000	33313	48149	41836	41918	41399	56499	24109	13402	12600	34803
	Rejection PPM	PPM	1000	1992	1997	2034	1559	1637	513	814	926	848	1369
	Rework PPM	PPM	1000	5785	4578	5581	6320	6215	8772	11111	4868	6580	6646
	OEE	%
QUALITY	No. of customer complaints received in accepted lots (including customer returns)	Nos	0	1	1	3	1	1	3	1	2	2	2
	Rejection PPM	PPM	1000	1992	1997	2034	1559	1637	513	814	926	848	1369
	MSA Planned Vs Actual	%	100	100	100	100	100	100	100	100	100	100	100
	No of Shop Floor Complaints on Accepted material	NO	0	0	1	1	1	1	2	1	1	1	1
	Clearence of MRN as per schedule	%	100	100	100	100	100	100	100	100	100	100	100
	Clearence of MRN as per schedule	%	100	100	100	100	100	100	100	100	100	100	100
	Timely Validation (Planned Vs Actual)	%	100	100	100	100	100	100	100	100	100	100	100
Tool Room	Cycle time of Die Development Plan Vs Ach	%	100	868	1127	1545	2164	976	2311	1357	1658	1246	1472
	Die Development Cost Plan/Ach.	Rs	As per Plan	211092	237240	479109	520029	390258	1039305	341777	693939	739041	516866
	Tool Breakdown Hour	Hour	100	151	225	216	249	236.25	224.5	204	205	204.83	213
	Tool Breakdown Frequency	Nos	30	39	64	78	78	76	56	75	85	80	70
	First Time tool Trial accepted ( Nos Of Tool Tried out Vs first time Accepted	%	100	93	78	80	87	91	89	87	77	79.5	85
	Average Die Life	Nos of Strokes
	Preventive Maint Planned Vs Achieved	%
	Ratio of cost of repairs vs. actual cost of die.	%
MARKETING	Number of New products Added	Nos.	13	0	0	3	4	0	2	6	1	9	3
	Enhanced Sales per Annum	%	1200	610.47	827.41	850.00	745.00	748.00	915.39	981.18	1049.45	1048.75	864
	No. of Enquiries handled Vs matured	Nos.	20	4	4	4	5	6	5	4	5	4	5
	Average time taken for closure of customer complaint	Days	7	7	7	3	1	1	3	1	4	4	3
	Number of customer complaints received per month.	Nos	0	1	1	3	1	1	3	1	2	2	2
	Customer Satisfaction Index	%	100	94.6	92.8	94.8	94.0	96.7	94.7	96.9	97.8	97.7	96
	VAPCO	%	6	1.57	2.47	2.58	2.7	3	3.5	3	3.25	3.3	3
	Number of improvements made in the products based on customer feedback.	Nos
PURCHASE	Supplier Performance Rating	%	100	91	92	94	92	93	94	92	94	90	92
	No. of suppliers upgraded to ISO System Every Year	Nos.	1	0	0	0	1	1	0	0	0	0	0
	No. of improvements made at supplier’s end	Nos.	5	2	1	1	1	2	1	1	1	1	1
	Execution of P.O as per schedule	%	100	88	89	88	89	87	88	89	87	88	88
	Production loss due to material non availability	Nos	0	2	2	2	3	2	1	2	2	2	2
	No. of time raw material rejected	Nos	0	1	1	1	1	1	2	1	1	1	1
STORE	No of. complaints related to transit & damage	Nos	0	0	1	1	2	1	2	1	1	2	1
	Matching of physical stock vs. recorded as per ERP	%	100	83	78	82	84	82	86	80	82	84	82
	Inventory Turn Over Ratio	%	25	10.5	12.84	15.64	12.75	14.75	15.72	16	15.75	16.25	14

Tagged
IATF 16949:2016

Published by Pretesh Biswas

Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your system development, training or auditing needs. He has helped dozens of organizations in implementing effective management systems to a number of standards. He provide a unique blend of specialized knowledge, experience, tools and interactive skills to help you develop systems that not only get certified, but also contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has experience in training at hundreds of organizations in several industry sectors. His training is unique in that which can be customized as to your management system and activities and deliver them at your facility. This greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety of industries achieve ISO 9001,14001,27001,20000, OHSAS 18001 and TS 16949 certification. Industries include automotive, metal stamping and screw machine, fabrication, machining, assembly, Forging electrostatic and chrome plating, heat-treating, coatings, glass, plastic and rubber products, electrical and electronic equipment, assemblies & components, batteries, computer hardware and software, printing, placement and Security help, warehousing and distribution, repair facilities, consumer credit counseling agencies, banks, call centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students. Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted over 100 third party registration and surveillance audits and dozens of gap, internal and pre-assessment audits to ISO/QS/TS Standards, in the manufacturing and service sectors. Other services: He has provided business planning, restructuring, asset management, systems and process streamlining services to a variety of manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage, warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education & professional certification: Pretesh Biswas has held IRCA certified Lead Auditor for ISO 9001,14001 and 27001. He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and Marketing. Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt . View all posts by Pretesh Biswas

Published July 5, 2023July 5, 2023