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S1.04. Case Study Manual EDU-QMS - LA-CSM-v1.1
S1.04. Case Study Manual EDU-QMS - LA-CSM-v1.1
AUTOMOTIVES
QUALITY MANAGEMENT
SYSTEM MANUAL
ABBREVIATIONS EXPANSION
PAC Pacific Automotive or Pacific Automotive Components
CA Corrective Actions
QA Quality Assurance
MR Management Representative
HO Head Office
PA Preventive Actions
FI Factory Inspector
S. No DEPARTMENT RESPONSIBILITY
1 DESIGN
2 ENGINEERING
3 PRODUCTION
4 QUALITY
5 MARKETTING
6 STORES
7 PURCHASE
8 SERVICE
9 EHS
10 INFORMATION SYSTEM
11 ACCOUNTS
12 HUMAN RESOURCES
INDIA
Pacific Automotive India Pvt Ltd 100% subsidiary of Pacific Automotive Germany and has set
up manufacturing facility in Chennai close to thickly populated National Highways. The
manufacturing facility is located in special Industrial park in which the facility spreads
around 28 acres of area and out of which 11,000 sq meters is covered area. The
construction activities of plant started in August 2008 and the facility started manufacturing
activities in August 2009. This facility is one of the most modern manufacturing facilities for
Chassis parts in the world.
The total manufacturing area spans into 10,000 square meter on 5 bays with a size of 100
meter x 20 meter and painting booth of 1,000 square meter. The maximum height of the
bay is 16 meters.
Plant Location:
Pacific Team:
Refer document; Organization Chart (HR - FRM - 11).
The internal context is the internal environment in which PAC seeks to achieve its
objectives. Risk management practices at PAC consider the following internal factors:
a) Governance, organizational structure, roles and accountabilities;
b) Policies, objectives, and the strategies that are in place;
c) Capabilities, understood in terms of resources and knowledge (e.g. capital,
time, people, processes, systems and technologies);
d) PAC’s culture;
e) decision making processes (both formal and informal);
f) standards, guidelines and models adopted;
g) Form and extent of contractual relationships.
The specific issues and related Quality and Environment are documented in the MR –
FRM - 09 form and are monitored and reviewed through management review
meetings.
b) The requirements of these interested parties that are relevant to the quality
and environment management system.
AF has envisioned the need for Quality management system to protect its own
interests and the interests of following stakeholders and interested parties:
a) customers– who need confidence in the products / services offered by PAC;
b) legal and regulatory authorities – who impose legislation and/or directives, in
order to ensure availability of products / services, fair competition and
privacy protection;
c) PAC employees – who strive to meet their obligations to the customers and
the public;
d) PAC management – who ensure that the business objectives are fulfilled, the
overall posture of PAC highlights quality as a culture, the vendors and
customers feel a goodwill and comfort with the services provided and that
VRV complies with all the regulation and laws;
e) business partners – who want theirs and PAC’s business objectives to be
fulfilled;
f) Vendors, suppliers and contractors – who demand that appropriate level of
standards are enforced to ensure that confidentiality of their service levels,
terms & conditions, prices, and other information is maintained.
The interested parties with any specific requirements are listed down in the same
document mentioned in 4.1 – Organizational Risk & Opportunity Register “MR –
FRM - 09”.
The specific requirements of these interested parties are monitored and reviewed
through management review meetings.
5 LEADERSHIP
5.1 Leadership and commitment
In PAC, the top management demonstrates leadership and commitment to the
quality management system by:
a) taking accountability for the effectiveness of the quality management
system;
b) establishing the QMS policy and objectives that are compatible with the
context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements
into the organization’s business processes;
d) ensuring that the resources needed for the quality management system are
available;
e) communicating the importance of effective quality management and of
conforming to the quality management system requirements;
f) ensuring that the quality management system achieves its intended results;
g) engaging, directing and supporting persons to contribute to the effectiveness
of the quality management system;
h) promoting improvement;
i) Supporting other relevant management roles to demonstrate their leadership
as it applies to their areas of responsibility.
QUALITY POLICY
PACIFIC AUTOMOTIVE COMPONENTS is committed to manufacture parts and
associated systems for automotive applications
This is achieved through:
Focus on quality performance
Prevention of undue risks
Compliance to statutory requirements
Involvement of its Employees
Motivation of all personnel
For the purpose of this manual and the quality management system, ‘top
management’ is defined as:
a) Managing Director;
b) Vice President
c) Head Operations
d) Management Representative
6 PLANNING
6.1 Action to address risk and opportunities
6.1.1 When planning for the QMS, PAC considers the issues referred to in 4.1 and
requirements referred to in 4.2 & determine the risks & opportunities that need to be
addressed in order to
a. Give assurance that the QMS can achieve its intended results
b. Enhance desirable effects
c. Prevent / reduce undesirable effects
d. Achieve improvement
The GGC shall maintain documented information on the quality objectives. Following
objectives have been documented:
6.2.2 When planning how to achieve its quality objectives, the PAC shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated
The QMS is monitored in planned manner through Audits and Management Reviews
with a view to ensure that integrity is maintained.
7.1.2 People
PAC shall ensure all the personnel performing work affecting quality and conformity
of products / services are selected on the basis appropriate education, experience,
training and skills
7.1.3 Infrastructure
PAC has identified the required infrastructure as below but not limited to
Office / factory buildings
Plant and machinery
Support equipment such as transport, communication and information systems
7.1.4 PAC shall determine and provide the work environment necessary to achieve
conformity to products and services and maintain good order housekeeping,
environment, safety etc.
7.1.5 PAC has identified the monitoring and measuring resources required to meet the
product conformity and ensure traceability for the same
7.1.6 PAC determines the knowledge needed for achieving its product conformity as per
clause procedure for competence
7.2 Competence
The Top Management, with the help of the MR and Head HR determines the
necessary competence of employees who have a direct or indirect impact on the
performance and effectiveness of the integrated management system. The
competence is determined on the basis of appropriate education, training, or
experience and is documented in the Competency Matrix “
Where applicable, the Top Management propose actions to acquire the necessary
competence, and evaluate the effectiveness of the actions taken. The evaluation of
an employee’s competence is initially done during the recruitment stage and on a
yearly basis. Based on the evaluation, the necessary trainings are provided
accordingly. The Training & Evaluation Record is retained as evidence of
effectiveness of the training undergone.
7.3 AWARENESS
PAC ensures that relevant persons (employees, contractors, third party) working
under PAC’s control are aware of:
a) the QMS policy;
b) relevant IMS and departmental objectives;
c) their contribution to the effectiveness of the quality management system,
including the benefits of improved performance;
d) the implications of not conforming with the quality management system
requirements
7.4 COMMUNICATION
PAC determines the internal and external communications relevant to the quality
management system through the procedure including on what to communicate,
when to communicate, with whom to communicate, how to communicate and who
should communicate with due consideration for compliance obligations and ensure
it is reliable.
7.5 DOCUMENTATION
At PAC the documentation is well defined as below
Level 4 • Records
8 OPERATIONS
8.1 Operational control
PAC shall plan, implement and control the processes (see 4.4) needed to meet the
requirements for the provision of products and services, and to implement the actions
determined in Clause 6, by:
a. determining the requirements for the products and services;
b. establishing criteria for:
1. the processes;
2. the acceptance of products and services;
c. determining the resources needed to achieve conformity to the product and service
requirements;
d. implementing control of the processes in accordance with the criteria;
e. determining, maintaining and retaining documented information to the extent
necessary:
1. to have confidence that the processes have been carried out as planned;
2. to demonstrate the conformity of products and services to their
requirements.
The output of this planning shall be suitable for the PAC’s operations. The PAC shall
control planned changes and review the consequences of unintended changes, taking
action to mitigate any adverse effects, as necessary. The PAC shall ensure that
outsourced processes are controlled (see 8.4).
The QMS of PAC defines the processes required for the automotive parts production.
The planning for producing Products as per customer requirements includes:
Setting of objectives
The process documents indicating monitoring & measurements and resources
The test methods required including sampling plans
The recoding methodologies as evidences and reference purposes etc.
Inputs shall be adequate for design and development purposes, complete and
unambiguous.
Conflicting design and development inputs shall be resolved.
PAC retains documented information on design and development inputs.
c. verification activities are conducted to ensure that the design and development
outputs meet the input requirements;
d. validation activities are conducted to ensure that the resulting products and
services meet the requirements for the specified application or intended use;
e. any necessary actions are taken on problems determined during the reviews, or
verification and validation activities;
f. Documented information of these activities is retained.
8.4 PAC shall ensure all externally provided products, processes and services conform to
the requirements
PAC applies criteria for evaluation, selection and re-evaluation of external providers
using External provider management record which is based on their ability to
consistently provide products, processes and services
PAC maintains record of controlled condition that includes first off / last off / line
inspection and router card.
PAC shall identify the status of outputs with respect to monitoring and measurement
requirements throughout production and service provision.
PAC shall control the unique identification of the outputs when traceability is a
requirement, and shall retain the documented information necessary to enable
traceability.
PAC shall identify, verify, protect and safeguard customers’ or external providers’
property provided for use or incorporation into the products and services. A register
of such properties are maintained by PAC covering complete details of origin, date of
receipt, intended use, storage location etc..
8.5.4 Preservation
PAC shall preserve the outputs during production and service provision, to the
extent necessary to ensure conformity to requirements.
PAC uses dedicated trays with separation of each part and special trollies for large
parts. Till the time product is sent for powder coating dewatering oil coat is applied.
PAC has its own transport arrangements for moving the products to and from external
providers and to deliver to customer with special design for preservation form any
deterioration
The release of products and services to the customer shall not proceed until the
planned arrangements have been satisfactorily completed, unless otherwise
approved by a relevant authority who currently is Senior Manager Product quality,
and, as applicable, by the customer.
PAC shall retain documented information on the release of products and services.
The documented information shall include:
a) Evidence of conformity with the acceptance criteria;
b) Traceability to the person(s) authorizing the release.
8.7
8.7.1 PAC shall ensure that outputs that do not conform to their requirements are
identified and controlled to prevent their unintended use or delivery.
PAC shall take appropriate action based on the nature of the nonconformity and its
effect on the conformity of products and services. This shall also apply to
nonconforming products and services detected after delivery of products, during or
after the provision of services.
PAC shall deal with nonconforming outputs in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and
services;
c) informing the customer;
d) Obtaining authorization for acceptance under concession.
Further the outcome is used to take appropriate decisions for enhancing the
performance of QMS and bring in continual improvements
10 IMPROVEMENT
10.1 General
PAC shall determine and select opportunities for improvement and implement any
necessary actions to meet customer requirements and enhance customer satisfaction.
The following system is followed for handling non-conformities and taking corrective
and preventive actions
a. Identifying non-conformity by monitoring and measuring process / product
parameters related to qualityaspects
b. Correcting and taking actions to mitigate their qualityimpacts
c. Investigating the root cause of the deviations
d. Taking actions in order to avoid their recurrence
e. Identifying potential non-conformities for the deviations and taking preventive
actions in order to ensure that the non-conformity does not occur.
f. Recording the results of corrective and preventive actions taken
g. Reviewing the effectiveness of corrective and preventive action taken
10.3 IMPROVEMENT
PAC continually improve the suitability, adequacy and effectiveness of the quality
management system to enhance performance.
Organization chart
CEO
Management
Business Head
representative
Head Head
Head Head
Manufacturin Customer Head HR
Operations Marketing
g service
Quality In
Charge
The following are issues of concern which have been, or may be ,raised by Internal and external
EXTERNAL
TYPE ISSUES BIAS
Not obtained or not renewal Factory
Legal environment License, Fire license, Pollution Control Negative
License
Internal
Knowledge Misunderstanding
Negative
Helmet, gloves, goggles are not wear
Safety
properly Negative
House Keeping FIFO and 5'S Techniques not followed
Negative
Interested parties are those stake holders who receive our products or services, who may be
impacted by them, or those parties who may otherwise have a significant interested in our
company.
Sl.
INTERSTED PARTY INTERNAL/EXTERNAL NEEDS AND EXPECTATION
No
Quality, price, & delivery of products
01 CUSTOMERS External
and services, proper communication
Product performance/ease of
02 END USERS External
use/reliability/safety/ maintainability
Good work environment/job
03 EMPLOYEES Internal security/health/safety/ training/
promotion, recognition and reward
Increased growth, sales &
04 MANAGEMENT Internal profitability/efficiency & effectiveness
of operations
Profitability/return on
LEADERSHIP/SHARE
05 Internal investment/growth in market value of
HOLDERS
organization
EXTERNAL PROVIDERS Prompt payment, Increase scope and
OF PRODUCT AND volume of purchases/long-term
06 SERVICES (SERVICE External contractual
PROVIDERS / arrangements/information on future
TRANSPORTERS) requirements.
Compliance with applicable
LEGAL AUTHORITIES
07 External requirements and industry
(GOVT.)
standards/submission of reports.
Qualityprotection/Ethical
behaviour/growth in business and
GOVERNMENT &
08 External taxes to build infrastructure to
COMMUNITY
support community services, activities
and institutions.
Support for new technology updating
09 COMPETETIOR External
and Knowledge sharing
BANK/FINANCE
10 External Good financial performance
Monitoring/
S. Process /
Measuring Frequency Responsibility Record Remarks
No Details
Point
Business
1. Director
Performance
Enquiry Executive
2.
Marketing conversion Director
Customer
Executive
3. perception
Director
level
On time
Executive
4. Design completion of
Director
D&D
Supplier
Head
5. performance
Operations
Purchase rating
Inventory Head
6.
Trend Operations
Hours of
Head
7. Training training
Operations
provided
Break down Half Yearly
8. Maintenance Head Mfg
trend
In Process
9. Head Mfg
rejection
Production On time
10. Head Mfg
delivery
11. Plan Vs Actual Head Mfg
12. Final rejection Head Mfg
On time
13. Quality Head Mfg
calibration
Customer
14. Head Mfg
complaint
Audit NC
15. MR MR
trend
Improvement
16. MR
Overall s achieved
17. Risk levels MR