Quality Manual

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Quality Manual

ISO/TS 16949:2002
AS9100 Rev A
ISO 9001:2000

Rev 0

Approved

Editor:
Approved:
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Change history

Edition Date Change

0 Approved
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Index

Change history.............................................................................................................................................2
1 Introduction, objectives and methods..................................................................................................4
1.1 Introduction:.................................................................................................................................4
1.2 Business Objectives.....................................................................................................................6
1.3 The method:.................................................................................................................................6
2 Quality Policy......................................................................................................................................7
2.1 Goals of the Quality Policy:.........................................................................................................7
3 Processes at XXXX..............................................................................................................................8
3.1 Sequence and Interaction of process............................................................................................9
3.2 Definition of processes..............................................................................................................10
4 Responsibility and authority..............................................................................................................18
4.1 General manager........................................................................................................................18
4.2 Quality Manager........................................................................................................................18
4.3 Technical Manager.....................................................................................................................19
4.4 Sales and marketing Manager....................................................................................................19
4.5 Operations manager...................................................................................................................19
4.6 Comptroller................................................................................................................................20
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1 Introduction, objectives and methods

1.1 Introduction:
This Quality Manual describes the Quality management System (QMS) of XXXX.
The objective of the Manual and the procedures, instructions and forms mentioned here is:
 To demonstrate the ability of XXXX to regularly supply products that are according to
the requirements of Customers, Laws and Industry Standards.
 To improve the level of Customer Satisfaction by the effective implementation of the
QMS including the process of continuous improvement.
 This QMS of XXXX is based on ISI/TS 16949:2002, AS9100 and ISO 9001:2000 and is
written in accordance to these standards

XXXX supplies to the automotive and other industries and the scope of the standard refers to
XYZXYZ

XXXX excludes from its QMS the design of YYYYYY for the Automotive and aeronautical
market as it receives drawings for the product from the OEM and thus designs the production
process only.
For sales to the After Market XXXX designs material and produces YYYYYY by reverse
engineering
XXXX uses outsourcing for some of its calibration, some production and tool building. These
are controlled by the purchase process and monitored. When required corrective actions are
requested form these suppliers. Use of these sources does not free XXXX from the responsibility
to its customers.
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The company “XXXX Engine YYYYYY” was founded in 1960 and went public in 1987 and is
traded on the Stock Exchange.
The company operates in the Automotive and Aeronautical industries manufacturing YYYYYY
for internal combustion engines. These YYYYYY are for engines used in automotives, trucks,
tractors, compressors, ships and propeller aircraft.
The company employees some 120 people.
Some 97% of the production is exported on 5 continents; the majority of the YYYYYY are for
the after market and the rest for the OEM’s
The main markets that XXXX sells to are: USA, South America, EU, South Africa, Australia,
Turkey and other countries in Asia and Africa.
The company’s products excel in their quality and accuracy and are intended for distributors and
mechanics of high performance engines for supply in all quantities and type.
The company only produces engine YYYYYY and uses production methods and control of the
most advanced in the field.
The development division of XXXX is dedicated to the development and production of new
materials which will increase the life of the bearing and reduce its cost. In the last 10 years
XXXX has specialized in the production of YYYYYY for racing cars according to special
requirements the require the development of YYYYYY with special geometry and alloys that
are unique to XXXX. These YYYYYY are mainly for the North American market.
XXXX has also built the ability in house to produce and control products and thus become an
approved supplier to the manufacturers of propeller driven aircraft.
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1.2 Business Objectives

Conformance with the requirements and expectations of the customers in the levels of quality
and in process control to ensure the product at least meets the specific requirements.
1.2.1. Performance of the work and supply to the customer on time
1.2.2. Customer satisfaction in the long run
1.2.3. Conformance with legal requirements
1.2.4. Supply of products and service in a fitting manner
1.2.5. Effective and efficient work whilst continually improving
1.2.6. Correct performance, first time continuously

1.3 The method:

1.3.1. Design and definition of the quality policy of the company:
Definition of the company’s goals in relation to quality as formally expressed by the
management as described in the various procedures
1.3.2. Design and definition of the quality management of the company:
Strategic planning, resource allocation, planning, implementation and control of the
quality whilst emphasizing the responsibility of the management
1.3.3. Design and definition of the QMS of the company:
Organizational structure, fields of responsibility and authority, procedures, design of
processes and resources needed for the implementation of the QMS
1.3.4. Design and control of the QMS of the company:
The techniques and actions in use to fulfill the quality requirements
1.3.5. Design of Quality Assurance in the QMS of the company
Planning of the resources and methods required
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2 Quality Policy
The company’s management will act to consolidate a system which will include all subjects
connected to assuring the quality in the plant and ensure that the finished product will conform
to the requirements as they appear on the order and will answer to all the customers’
expectations.
The management will act according to the organizational structure and the allocation of
resources and trained and qualified staff to ensure in the best manner the quality of the product
and the requirements of the customer and prevent the production and supply of non conforming
products.
The management will implement an efficient and effective QMS according to the requirements
of ISO/TS 16949:2002, AS91000 and ISO 9001:2000.

2.1 Goals of the Quality Policy:

 Customer Satisfaction by implementing the quality required and reduction of
costs of poor quality
Conformance to planned timetables
 Effective and efficient management of processes which will prevent
unnecessary expenses and will contribute to increased efficiency and continuous
improvement
 Nurturing of the Human capital by training and education as needed.
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3 Processes at XXXX
XXXX identifies in this manual the processes that are required to maintain the QMS and to the
requirements of ISO/TS 16949:2002, AS9100 and ISO 9001:2000 in the following manner:
Customer Orientated Processes (COP’S), these are processes that have a direct connection to the
customer.
Support Orientated Processes (SOP’S) internal processes needed to support the COP’S
Management Orientated Processes (MOP’S) of the system which are used as controls
These processes are based on the PDCA model and actions are planned, implemented, checked for
effectiveness and corrective actions or improvements implemented

The interaction of these processes can be seen in the following table. The processes are defined to show
their inputs and outputs, owner and basic documentation including references to the procedures and/or
work instructions when relevant. Included is the method of monitoring and measuring the effectiveness
of the process. When effectiveness is not proved then corrective actions are taken. The monitoring also
allows for the collection of data for continual improvement.
XXXX operates a monitoring and analysis system based on the Quality Delivery and Cost model which
measures the following:

 Not right first time

 Delivery schedule achievement
 People productivity
 Stock turns
 Overall equipment effectiveness
 Value added per person
 Floor space utilization
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3.1 Sequence and Interaction of process

Implementation and maintenance of the QMS

Quality Policy and processes implemented and maintained
QMS planning
Resource management
Management review

Corrective and
preventative actions Internal audits

Customer

RFQ Initial order Repeat order

Review

Production planning

PPAP APQP
Purchasing
Equipment and facility management
Infrastructure
Work environment Production
Customer property
Measuring and monitoring devices
Inspection and Shipping
packaging

Production process controls

Non conforming product
Identification and traceability
Preservation
Document control
Record control
Process and product monitoring
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3.2 Definition of processes

Process Type Owner Actions Inputs Outputs Documentation Monitoring Measurement of

effectiveness

Review of COP Feasibility study Customer Quotation Contract review Time for reply Number of orders
customer request
requirements Credit rating Order

Offer Definition of Production Records  Profitability 

part planning  
Approval of order
Part and COP Conversion of Requirements Approved process APQP Timetable Time to approval
process requirements of of part procedure  
design customer to part Special work Cost
APQP and process that requirements of instructions
will satisfy him customer
Customer Approved part PPAP Cost Zero series
timetable    
Results of design control  
feasibility and
contract review
Production COP   Planning of Customer Production Internal orders  Orders production
planning production orders and planning   efficiency
forecasts stock orders On time delivery
Production COP Receipt and Production plan Metal strips for Work Monitoring of Efficiency (ratio
of strips approval of raw production of instructions inputs (cost and of outputs to
material YYYYYY   quantities) inputs)
Conversion of raw Specifications Output (Gross  
Production material and work and scrap) 
of strips instructions
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Process Type Owner Actions Inputs Outputs Documentation Monitoring Measurement of

effectiveness
Control of receipt, Machinery and Failures
process and infrastructure
material
Raw material Quality records  Production
Workers targets

Production COP Conversion of Production plan Parts according to Work Monitoring of Efficiency (ratio
of YYYYYY strips to customer instructions inputs (cost and of outputs to
YYYYYY Specifications requirements quantities) inputs)
and work
instructions

Raw material Quality records Output (Gross

and scrap
Machinery and  Production
infrastructure targets

Workers Failures

Packaging COP   Receipt and Supply plan Dispatch to the Work Timetable Conformity to
and dispatch approval of agreed with customer in the instructions (deviations program
packaging customers packaging and on reported to  
time sales)
Packaging Packaging
Packaging according to specifications
and dispatch customer
requirements

Interim storage Packaging  Quality records

materials   
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Process Type Owner Actions Inputs Outputs Documentation Monitoring Measurement of

effectiveness

Planning of Workers  Conformity to

dispatch and customer
preparation of requirements 
documents

Dispatch Machinery and

infrastructure

Invoice and COP   Invoice according Delivery notes Invoices Invoices  Tracking of  % of collection
collection to the agreed invoices

Collection Orders Money Records

Customer COP   Treatment of  Requests Replies,  Reviews,  Time of reply  Customer

Feedback customer requests comments and meetings and to customer satisfaction
Reviews improvements letters
Analysis of Complaints
customer
satisfaction Comments

SOP   Preventative Maintenance Repairs to Maintenance Reaction time Standard time

Maintenance     maintenance plan machinery and procedure and actual time
  infrastructure
 
Installation and Reports on New equipment Maintenance Cost of
adaptation of new maintenance plan maintenance
equipment problems
 
Maintenance Machinery and Effective stock of Technical Repeat  Reduction of
 
infrastructure replacement parts literature problems downtime
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Process Type Owner Actions Inputs Outputs Documentation Monitoring Measurement of

effectiveness

  Management of Technical
spares literature

Tooling SOP   Manufacture and Production plan Production tools Drawings Production Production
preventative   timetable timetable
maintenance of  
tools  

Maintenance Internal orders

Support to Machinery and Tool records Monitoring of Reduction of

maintenance infrastructure   sub contractors downtime
     
Technical
literature

Purchasing SOP   Stock Production plan Stock of raw Purchase Order Adherence to
Raw Material management, material procedure monitoring plan
Purchasing order point  
Raw Material  
Follow up of Historical data Approved Size and value Cost of shortage
orders supplier list of stock

Price reviews Material Material Supplier Effective stock

specifications specifications evaluation

Purchasing SOP   Contract with Customer Semi finished Purchase Order Adherence to
semi finished supplier orders goods  procedure monitoring plan
Follow up of Approved Approval of Cost of shortage
orders supplier list first sample
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Process Type Owner Actions Inputs Outputs Documentation Monitoring Measurement of

effectiveness

Price reviews Drawings and Purchase Supplier Customer

technical specifications evaluation satisfaction
specifications
 

Movement SOP   Loading, WIP Protected and Identification Non Complaints due
and unloading and identified tags conformance to mixed parts
identification movement of products in the due to lack of
on work flow containers Storage and correct place  Non preservation
between stations movement   conforming
equipment   product
Preservation of procedure Level of
product rejections as a
result of lack of
Identification of Routing cards Status preservation
status at all stages identification

Calibration SOP   Calibration and Equipment Measuring Calibration Follow up on Calibration

of measuring verification of equipment procedure calibration timetable
equipment equipment calibrated and status and
conforming to Calibration usability
Storage and Measuring requirements specifications Improvement of
protection of procedure measuring
equipment Calibration confidence
records
Measurement External Confidence in
system analysis laboratory measuring ability
 
Identification of MSA
equipment
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Process Type Owner Actions Inputs Outputs Documentation Monitoring Measurement of

effectiveness

Training SOP   Identification of Plan for HR in Skilled and aware Training plan Implementation Increase of
training needs and business plan workers of training plan output
organizational
development Training aids Increased Training
motivation Procedure

Development of Internal growth Records of Measurement Improvement of

training plan and and improvement training and of results quality, reduction
training methods of use of qualifications (outputs, waste, of non
information   set up time etc conformance’s
Implementation of External
training training
organizations
 Connection to   * Qualification Increase of
organizational and empowerment satisfaction and
targets of staff identification
with XXXX

Treatment of SOP   Identification of Engineering Customer Procedure for Tracking of Number of

non non conforming specifications satisfaction control of NCM CAR's customer
conforming material complaints
material
Quarantine of Control plan Savings
NCM Time of
Training and Corrective action Tags identification
Decision as to qualifications requests 1. Where
treatment 2. When

Analysis of cause CAR Continuous Corrective

of failure improvement of actions
processes procedure
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Process Type Owner Actions Inputs Outputs Documentation Monitoring Measurement of

effectiveness

Corrective MOP   Decisions as to Customer Savings of poor Tracking of Non

actions treatment of root complaint quality costs Preventative CAR's reoccurrence of
cause to prevent actions non
reoccurrence procedure conformance’s
Records
Audit findings Savings of poor Timetable for
quality costs closing CAR's
 Analysis of Discovery of Customer  
possibility of non satisfaction
failures conformance in  
process

Suggestions of Continuous Tracking of

workers improvement of actions
processes

Preventative MOP   Decision as to FMEA Savings of poor Records  Tracking of Non occurrence
actions treatment quality costs   actions of failure
 
Audit findings

Customer Customer Timetable for

communications satisfaction closing PAR's

 Management  MOP   Review of Information on Decisions of the Form which Meeting every Customer
Review suitability and efficiency and management to instructs as to half year satisfaction
efficiency of QMS effectiveness of improve the the inputs and No
Review of the plants quality system outputs of the nonconformances
possibilities of system in and its processes review and in audits
improvement relation to and products supporting
Decisions for customer Resources needed information
actions requirements
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Process Type Owner Actions Inputs Outputs Documentation Monitoring Measurement of

effectiveness

Internal MOP   Inspection of Audit plan Continuous

audits conformity to Qualified CAR's Audit procedure improvement as a
requirements of auditors result of
the standards, the corrective actions
QMS and the Previous audit  
products reports

Effective Audit plan Recommendations Reports Reduction of

implementation of for improvement complaints and
the QMS non
conformance’s
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4 Responsibility and authority

4.1 General manager
4.1.1. Overall responsibility for the quality of the products supplied to the customers
4.1.2. Communication and interpretation of the Companies policy and goals to all
members of staff
4.1.3. Determining the quality goals and Tracking of the quality levels in the plant in
relation to those determined
4.1.4. Appointment of multi disciplinary teams as required.

4.2 Quality Manager

4.2.1. Preparation of the required documentation for the QMS- preparation and
approval of test and inspection criteria for all the stages of acceptance of raw
material and production, design and preparation of inspection and testing forms.
4.2.2. Inspection and testing of raw material, material in production and final
inspection.
4.2.3. Approval of products as acceptable or not to requirements, approval of use of
suspect material and identification and Tracking of non conforming material and
products. Management of the MRB and approval of decisions
4.2.4. Determining the needs of the plant for test and inspection equipment and the
maintenance, storage and control of this equipment
4.2.5. Support to management and staff in the identification and solution vof problems
in work processes and initiation of improvement activities to increase the quality
level and prevent reoccurrence of problems
4.2.6. Inspection and approval of technical documents – drawings, specifications etc
that are sourced from the technical office.
4.2.7. Recommendation as to approval or rejection of suppliers and evaluation of
performance.
4.2.8. Coordination of multi disciplinary teams.
4.2.9. Management representative with the responsibility to ensure that the QMS is
established, implemented and maintained and to report on the state and need for
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change and improvement. To promote the importance of the customer and has the
authority to resolve matters relevant to quality
4.2.10. Customer representative with the responsibility and authority to ensure that
customer requirements such as choice of critical/key characteristics, targets
corrective and preventative actions are addressed.

4.3 Technical Manager

4.3.1. Supply of design, development and maintenance to production departments
and the management
4.3.2. Control and maintenance of engineering drawings
4.3.3. Feasibility studies of requirements and technical input to contact reviews
4.3.4. Training for technical subjects

4.4 Sales and marketing Manager

4.4.1. Preparation of strategic plan for the long term and tactical plan for the short run
4.4.2. Appointment of agents.
4.4.3. Communications with customers until delivery of goods
4.4.4. Actions to increase sales and market awareness
4.4.5. Review of customer requirements, documentation of RFQ’s and orders.
4.4.6. Marketing input to contact reviews
4.4.7. Treatment and Tracking of customer complaints.

4.5 Operations manager

4.5.1. Coordination and management of all operations that are connected with
production and delivery of goods to the Israeli ports. Prioritization, coordination
and management of transport according to the instructions and the production plan
4.5.2. Planning of short term work requirements including mobility between
departments. Authority to change processes that are in his view damaging the
quality of work.
4.5.3. Implementation of the production processes and inspection and testing
requirements in accordance with the procedures and instructions of the company
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4.5.4. Initiation and implementation of actions to improve the quality of products

including improvement of processes and updating instructions on the basis of root
cause analysis

4.6 Comptroller
4.6.1. Management of cash flow
4.6.2. Management and Tracking of organizational budgets
4.6.3. Cost accountancy and support for other departments
4.6.4. Management of financial monitoring and wage calculation
4.6.5. Preparation of import and export documents and Tracking of collection