Major Clauses.

4.Context of the Organization

5.Leadership

6.Planning

7.Support

8. Operation

9.Performance Evaluation

10.Improvement.
4.Context of the Organization
4.1. Understanding the Organization and its Context

Determine External and Internal Issues .

Relevant to the Purpose and Strategic Direction.

Monitor and Review these issues.

 External Issues Internal Issues

Environmentally Friendly Vehicles. Culture ,Values and Beliefs .

Driverless Vehicles. Employee Motivation.

Electric Vehicles . Leadership styles.

Global Competition. Stress in Work.

Cost Reduction Pressures. Rejections/Rework.

Government Policies. Frequent set up changes.

Rapid Growth in Technology . Work Environment .

Manpower Availability . Working Together.

 4.2. Understanding the Needs and Expectations of Interested Parties.
Person or
Organization
can affect /be
affected.
Determine Relevant Interested Parties.

Determine their requirements relevant to Business .

Monitor and Review these requirements .

Need Expectation
Material Emotional
happiness Happiness
 Interested Parties

Customers - Trust , Zero Defects. Trade Unions -Win/Win situation.

Suppliers - Growth ,Ontime Payment Neighbours -Cooperation

Investors - ROI, Stability. Stock Exchange – Business Ethics .

Employees -Growth , Culture. Dealers –Growth

Government - Corporate Governance. Society –Employment , Growth.

Statutory Bodies- Compliance. Educational Institutions –Employment.

Bankers – No defaults. Security agencies- Loyalty ,Trust

Insurance Companies- Fair Settlement Hospitals – On time settlement.

4.3. Determining the Scope of the Quality Management System.

Determine the Boundaries and applicability.

When Determining the Scope Consider
Customer Specific
External and Internal Issues. Requirements –
Evaluate and
Requirements of the relevant Interested Parties.
Include in the
Products and Services. Scope
Maintain as Documented Information.

Provide Justification for any Exclusions.

Support Functions to be Included in the scope.

Only permitted Exclusion with in Product Design. MFG Process Design Not excluded.
 Scope Examples

Design and Manufacture of Suspension Systems

Exclusions : Nil

Manufacture of Precision Machined Components .

Exclusions : 8.3.3.1 & 8.3.5.1
Justification : Customers provide the Prints and Specifications.
Determine the Processes needed for the QMS.

4.4. QMS and

Determine the Inputs and Outputs.
its Processes.

Determine the Sequence and Interactions.

Determine and apply criteria and Methods for Operations and Control.

Determine the Resources.

Assign Responsibilities and Authorities.

Address the Risks and Opportunities .

Evaluate the Changes.

Improve the Processes.

 4.4 .Quality Management System and its Processes

Vishuddha Engineering is Designing and Manufacturing Clutches located in Bangalore .The

major Customers are Ford India and Hyundai . This Organization is existing in Business from
the past 12 Years . There are 12 Suppliers for this Organization. There are Three directors.
The Customers are Expecting 100% on time delivery and Zero defects. There are 300
Employees working in this Organization. This organization has to comply All the Legal and
Regulatory requirements . The overall knowledge level in the organization is below the average
industry benchmarking level.
The Design centre is at New Delhi and there are two warehouses located in Pune and Chennai.

The vision ;
To become a World Class Clutch Manufactures by 2025.

Mission :
By implementing Lean Manufacturing Practices.
Empowering the Employees.
Enhance Customer Loyalty .
Values : Integrity ,Trust ,Respect.

Identify the Business Processes required for this Organization.

 Marketing ,Product & Process Design , Manufacturing , Packing &
COP Despatch.

MP Business Planning ,Management Review , Internal Audit ,Finance

IT, Stores, Purchasing, QA, HR, Maintenance, Tooling , Documentation,

SP CA, PA, Continual Improvement .
Process Sequence

Product & Process Design

Manufacturing

Marketing Quality Assurance

Packing

Despatch
 Process Interactions

Business Maintenance
Finance Purchasing
Planning

Continual
Improvement

Product
Quality Packing &
Marketing &Process Manufacturing
Assurance Despatch
Design

Internal
Audit HR Stores

IT
 Determine and apply criteria and Methods for Operations and Control.

Effectiveness :

Extend to which Planned activities are realized and Planned results are achieved.

Customer Interest .

Efficiency :

The Results achieved and the Resources used .

Organization Interest .
 Effectiveness
No of Customer Complaints .
Delivery Performance .
Calibration –Plan vs Actual.
Production plan vs Achieved.
No of Training Completed.
Customer Audit Score.
Customer Satisfaction.
Efficiency
Cost of Poor Quality .
Internal Rejection.
Productivity .
OEE .
MTBF ,MTTR.
Cost per Component .
Energy cost/Component.
Determine the Resources. Responsibilities &Authorities

Responsibility = Accountability.
Human Resources. Authority :
Knowledge. Power to take Decision.
Land ,Building & Infrastructure. Initiate Actions.
Plant Lay out . Approval of Reports .
Equipment and Utilities. Giving orders.
Measurement Resources. Reviewing the progress /Status.
Work Environment. Manage the Changes.
 Risks Opportunities.

Consistent Cost Pressure.

Market is growing.
Technology upgradation.
Availability of Funds.
Dynamic Business Environment.
Less competition in some segments.
Manpower Availability.
Loyal Customers.
Supplier Quality .
Dedicated Employees.
Logistics .
Brand image .
Government Policies.

Prevent or Reduce the Undesired Effects. Enhance the Desired Effects

Evaluate the Changes – Improve the Processes.

 4.4.1.1. Conformance of Products and Processes.

Ensure Conformance of all Products and Processes including Service Parts and Outsourced Parts to all
applicable Customer, Statutory and Regulatory Requirements .
 4.4.1.2 –Product Safety

Note : Please refer IATF 16949 FAQ dt 18.11.18

QUESTION: What is the scope of this clause? Many organizations focus on regulatory/statutory requirements
of the product and do not believe they have product safety related manufacturing product or processes.

ANSWER: This clause focuses on product and manufacturing process characteristics that affect the safety
performance of the final assembly. These characteristics may not be directly addressed in
regulatory/statutory requirements, but may be defined by the customer.

Design Responsible Organization : May identify these requirements and related Customer Notification.

Non Design Responsible Organizations : May be provided by the Customers.

 Crank Shaft
Product Parameters :

Requirement : High Wear and Fatigue Resistance. Case Hardening - 55-58 HRC

Case Depth - 1.6- 1.8 mm.

Process Parameters :

Power : 12.0- 12.5 Kw.

Feed rate : 300- 320 mm/sec.

Quench Flow rate : 12 Lit/Min.

4.4.1.2 –Product Safety

Documented Process
Product Parameters :

Case Hardening - 55-58 HRC

Applicable to Product safety related Products and Manufacturing Processes.
Case Depth - 1.6- 1.8 mm.

Identification by the Organization of Product safety requirements.

Notification from the Customers Process Parameters :

Power : 12.0- 12.5 Kw.

Special Approval for DFMEA Feed rate : 300- 320 mm/sec.

Quench Flow rate : 12 Lit/Min.

Identify Product Safety related Characteristics.

Reaction Plans.

Define Responsibility and Escalation process to Top Management and Customers.

Training identified by the Customers and Organization

4.4.1.2 –Product Safety

Incorporate with Change Management .

Transfer the requirements to supply chain

Product Traceability throughout the Supply Chain

Lessons learned for New Product Introduction.

To the extent necessary – Maintain and Retain the Documented Information.