 |
Quality System Manual October 29, 2003
ISO/TS 16949 BASED QUALITY SYSTEM MANUAL
1.0 QUALITY SYSTEM MANUAL
1.1 PURPOSE:
The purpose for this Quality System Manual is to establish the scope of
the quality management system, to define the quality management
processes and their interactions, and to reference established
documented procedures that provide additional structure to the system.
This manual, the defined processes and the documented procedures form
the basis for an effective Quality Management System. The goal of this
system is to enhance customer satisfaction by emphasizing continual
improvement and the prevention of nonconformities.
1.2 SCOPE:
The Quality Management System consists of 11 processes with
interactions that satisfy the requirements of our customers and of the
TS 16949 technical specification (excluding permitted exclusions).
Within the description of these 11 processes are referenced procedures
that guide the processes. All TS 16949 required procedures are found
within these processes. Other procedures that QSR deems necessary for
the performance of the processes are included.
All permitted exclusions are included in section 7.3 of TS 16949.
Exclusion:
All references to "Product Design and Development" in ISO/TS 16949
Section 7.3
(mainly sections 7.3.2.1 Product design input and 7.3.3.1 Product
design outputs).
Justification:
QSR is not product design responsible. Product design is
controlled and approved by the customer.
1.3 DOCUMENT RESPONSIBILITY:
The Quality Systems Engineer maintains the Quality System Manual.
The process for updating the Quality System Manual and methods for
determining the revision history are detailed in procedure QA-05-001-P,
Control of QSR Policy Manuals.
1.4 DISTRIBUTION:
QSR electronically accesses the Quality System Manual. Printed copies
for Sales and Auditor distribution are marked "Uncontrolled". The
methods for control and distribution are explained in procedure QA-05-
001-P, Control of QSR Policy Manuals.
1.5 APPROVAL:
QSR records the revision level, issue date and authorized functions in
the Quality System Manual. The President / CEO and Quality Manager
approve policy changes to the Quality System Manual. The Registrar
is informed in writing of significant changes to the Quality System.
-------------------------------------------------------------------------
2.0 TABLE OF CONTENTS (sections only, no page numbers)
ISO/TS 16949 BASED QUALITY SYSTEM MANUAL
1.0 QUALITY SYSTEM MANUAL
1.1 PURPOSE
1.2 SCOPE
1.3 DOCUMENT RESPONSIBILITY
1.4 DISTRIBUTION
1.5 APPROVAL
2.0 TABLE OF CONTENTS
3.0 INTRODUCTION
3.1 QUALITY POLICY
3.2 QUALITY OBJECTIVES
3.3 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
3.3.1 Responsibility for quality
3.3.2 Management representative
3.3.3 Customer representative
3.3.4 Internal communication
3.4 HIGH-LEVEL PROCESS INTERACTIONS
3.5 PROCESS SPECIFICS
3.5.1 Leadership Process
3.5.2 Customer Assistance Process
3.5.3 Manufacturing Design Process
3.5.4 Inbound Process
3.5.5 Manufacturing Preparation Process
3.5.6 Manufacturing Process
3.5.7 Outbound Process
3.5.8 Customer Satisfaction Process
3.5.9 Personnel Management Process
3.5.10 Maintenance Process
3.5.11 Improvement Process
3.6 PROCEDURE CROSS- REFERENCE
-------------------------------------------------------------------------
3.0 INTRODUCTION
QSR was established in 1966 on the premise that a need existed
within the industrial and automotive markets for a company capable of
providing custom molded Elastomeric components at a consistent and high
quality level. Due to careful planning, a commitment to quality, using
dedicated quality-minded employees and state-of-the-art equipment, QSR
has enjoyed steady growth.
Manufacturing excellence and continual improvement is the top
operating priorities at QSR. The Quality System is designed to ensure
that quality is built into the product by utilizing advanced product
planning, manufacturing stability and control, and statistical
techniques.
QSR will maintain and continually improve the Quality System to
ensure that customer satisfaction is achieved.
3.1 QUALITY POLICY:
Quality Synthetic Rubber is committed to providing "World Class"
precision molded Elastomeric components.
This commitment is a company wide dedication to continuous improvement
and customer satisfaction.
3.2 QUALITY OBJECTIVES:
QSR is dedicated to continual quality improvement and exceeding
customer requirements. QSR achieves this commitment by tracking and
improving the performance of our quality objectives:
* On Time Delivery
* Total Part Scrap
* Customer Returns
* Average Molding Dollars Per Press Hour
* Shipping Dollars Per Employee
QSR's Goal - to be recognized by our customers as number One in the
field.
To reach that goal WE MUST CONTINUALLY IMPROVE EVERYTHING WE DO.
QSR's policy is understood, implemented and maintained at all levels
of the organization and is relevant to QSR's quality objectives.
3.3 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
Top management ensures that the organization defines and communicates
descriptions for personnel who manage, perform and verify work
affecting quality in a job description format. The interrelation of
personnel affecting quality is represented on the QSR Organization
Chart. Reference AD-01-005-F.
3.3.1 Responsibility for quality
Responsibility for Quality rests with every individual employee at
Quality Synthetic Rubber. Each person is responsible for the quality
of their work. Personnel with the responsibility and authority for
corrective actions are promptly informed of products or processes that
do not conform to requirements and have the authority to stop
production to correct quality problems. All shifts are staffed with
personnel responsible for quality with the responsibility of ensuring
product quality.
3.3.2 Management representative
QSR's Top Management has assigned the authority and responsibility for
ensuring that QSR's Quality System is in accordance with the ISO/TS
16949 Technical Specification to the Quality Systems Engineer.
The Quality Systems Engineer has the responsibility to:
a) ensure that the documentation, implementation and maintenance of
the Quality System and its processes are in accordance to ISO/TS
16949 Technical Specification,
b) to report on the performance of the Quality System to QSR Top
Management as a basis for improving the Quality System, and
c) to ensure the awareness of customer requirements throughout the
organization.
3.3.3 Customer representative
QSR's Top Management has assigned the authority and responsibility for
ensuring that customer requirements are addressed to the:
* Quality Manager (represents the needs of the customers during
selection of special characteristics, setting quality objectives
(with related training) and corrective/preventative actions)
* Sales/ Engineering Director (represents the needs of the customers
concerning design and development specifications)
* Director of Technology (represents the needs of the customers
concerning design and development of raw material specifications
and testing)
3.3.4 Internal communication
QSR's Top Management has ensured that the appropriate communication
processes are established by authorizing the following committees:
* SAP Committee (is a multi-disciplinary team with the
responsibility for the quality planning process and communicating
the output from this process to the appropriate job functions)
* Steering Committee (has the responsibility to communicating the
effectiveness of the quality management system)
-------------------------------------------------------------------------
3.4 HIGH-LEVEL PROCESS INTERACTIONS
+------------------------------------------------------------------------------------------------+
| Leadership |
| (All processes provide feedback and receive direction from Leadership.) |
+------------------------------------------------------------------------------------------------+
+------------------------+
| CUSTOMER |
| (requirements) |
+------------------------+
| |
| |
| |
| | +----------------+
+------------+ +---------------+ | Inbound |
| | | |-------->| |
| | | | +----------------+
| | | | |
| | | | |
| | | | +----------------+
| | | | | Manufacturing |
| | | |-------->| Preparation |
| Customer |-->| Manufacturing | +----------------+
| Assistance | | Design | |
| | | | |
| | | | +----------------+ +-----------------+ +------------------------+
| | | |-------->| Manufacturing | | Customer |-------->| |
| | | | | | | Satisfaction | | Improvement |
| | | | +----------------+ +-----------------+ | |
| | | | | | |(This process involves |
| | | | | | | the entire organization|
| | | | +----------------+ +-----------------+ | and is directly |
| | | |-------->| Outbound |-------->| CUSTOMER |<------->| influenced by customer |
+------------+ +---------------+ | | | (Perceptions) | | perceptions.) |
+----------------+ +-----------------+ +------------------------+
+------------------------------------------------------------------------------------------------+
| Personnel Management |
| (This process receives input and provides resources for all processes) |
+------------------------------------------------------------------------------------------------+
+------------------------------------------------------------------------------------------------+
| Maintenance |
| (This process may recieve input and provides service for all processes) |
+------------------------------------------------------------------------------------------------+
-------------------------------------------------------------------------
3.5 PROCESS SPECIFICS
3.5.1 Leadership Process
Leadership (Q1)
Purpose Developing: Q. Policy, Q. Objectives
Developing: Business Plan
Communication of key measures
Customer Focus
Analyzing Data
Making rational decisions
Employee Recognition
Owner President / CEO
Required Directors and Managers
Personnel
Process Customer Communication
Inputs Management Reports
Procedures/ Management Review, AD-01-004-P
Methods Steering Committee, QA-02-004-P
Business Plan, AD-01-001-P
Organizational Communication
Management Meetings
Employee Recognition
Business Trips
Equipment/ Telephone
Materials Computer
Network Programs
Process Satisfied customers
Outputs Business Plan
Required Resources defined
Improved QMS and processes
Measurement/ Key Business Performance Indicators
Assessment QMS effectiveness assessment
3.5.2 Customer Assistance Process
Customer Assistance (Q2)
Purpose Researching market needs and desires
Locating potential customers
Developing Market Strategy
Selling
Analyze & track customer perceptions
Communicating perceptions to organization
Providing customer assistance
Owner Director of Sales
Required President / CEO
Personnel Sales/Engineering Director
Sales Reps
Process Customer needs and desires
Inputs Customer feedback
Procedures/ Customer Visits
Methods Sales Calls
Feasibility Review, SA-02-001-P
Inquiry Quotation, SA-03-001-P
Equipment/ Telephone
Materials Computer
Network Programs
Process New customers
Outputs New Orders
Profitable company
Measurement/ Sales reports
Assessment Sales Rep reports
Quote activity summary
Feasibility Review summary
3.5.3 Manufacturing Design Process
Manufacturing Design (Q3)
Purpose Understand Customer Requirements
Convert requirements to design inputs
Design activity planning and coordinate with process leaders
Develop process output to meet input
Monitor design progress - Verify & Validate
Communicate & control design information & documents to other processes
Owner Sales/Engineering Director (engineering)
Director of Technology (material)
Quality Manager (quality)
Required SAP committee
Personnel Materials lab personnel
Dimensional lab personnel
Production personnel
Tool Vendors
Process Customer requirements (i.e. special characteristics)
Inputs Customer drawings
Customer expectations
Customer production forecasts
Lessons learned from prior experience
Cost requirements
Procedures/ Advance Quality Planning, QA-02-001-P
Methods Simultaneous Advanced Planning, QA-02-002-P
Production Part Approval Process, QA-02-003-P
Prototype, EG-04-001-P
Tooling Purchase Order, EG-06-001-P
Prelaunch, EG-02-001-P
Material Development, ML-02-001-P
Customer Supplied Material, MG-07-001-P
Control of Process, Inspection & Test, QA-05-007-P
SAP Meetings
Equipment/ Telephone
Materials Computer / Network programs
Manufacturing equipment/tools
Tool vendors computer programs
Material & Dimensional test equipment
Process Control plan, Router, Work instructions, Product acceptance criteria
Outputs FMEA, Error-proofing, First-time quality
Data for quality, reliability, maintainability & measurability
Manufacturing Requirements / Material Requirements
Drawings/Special characteristic requirements
Measurement/ Process Capability
Assessment First-time quality
PPAPs On-time
Pressure Checks
3.5.4 Inbound Process
Inbound (Q4)
Purpose Supplier communication
Evaluate & Select Suppliers
Purchasing supplies & equipment
Receiving inspection
Receiving product handling
Optimizing Inventory
Owner Buyer
Required Receiving clerk
Personnel Materials lab personnel
Dimensional lab personnel
Milling Supervisor
Production Manager
Process Drawings/Special requirements
Inputs Parts Due Listing
Customer specified suppliers
Supplier communication
Inventory Reports
Regular Material Meetings
Procedures/ Purchasing Control, PR-06-001-P
Methods Vendor Control, PR-06-002-P
Premium Freight, PR-06-004-P
QSR Requisition, PR-06--003-P
Receiving Inspection, QA-10-001-P
Identification & Traceability, MG-08-001-P
Equipment/ QSR Network Programs
Materials Computers/Scanners
Telephone
Material & Dimensional test equipment
Process Approved Vendor List
Outputs Supplier Development
Good raw material
Material delivery on-time
Reduced Inventory
Vendor Rating Analysis
Measurement/ Supplier Evaluations
Assessment Downtime due to material shortage
Vendor Rating Analysis
Premium Freight
3.5.5 Manufacturing Preparation Process
Manufacturing Preparation (Q5)
Purpose Communication resource needs to inbound process
Scheduling Work
Arranging Resources
Verifying raw material conformity
Owner Director of Manufacturing
Director of Technology
Required Production Manager
Personnel Raw Material personnel
Material Lab personnel
Dimensional Lab personnel
Process Parts Due Listing
Inputs Orders/Pull Signals
Daily Production Reports
Work Procedures & Instructions
Procedures/ Production Scheduling, AD-15-003-P
thods Customer Purchase Order Review, SA-03-002-P
Mold Setup, MG-09-003-P
Receiving, SR-06-001-P
In-Process Material, ML-10-002-P
Shelf Life, ML-09-001-P
Equipment/ Computers
Materials Customer Communication (EDI, Fax, Email)
Network Programs
Weekly Material Meetings
Process 24 hour manufacturing schedule
Outputs Raw material ready for manufacturing
Tooling ready for manufacturing
Measurement/ On-time Delivery
Assessment Premium Freight
Customer Satisfaction Reports
Rejected Material scrap dollars
Benchmark of materials
3.5.6 Manufacturing Process
Manufacturing (Q6)
Purpose Manufacture through transformation activities
Verify product conformity
Providing feedback within the process
Final product release
Owner Director of Manufacturing
Production Manager
Quality Manager
Required Manufacturing Supervisors
Personnel Manufacturing Personnel
Quality Personnel
Material Lab Personnel
Process Prepared Molds, Presses, Materials
Inputs 24 Hour Manufacturing Schedule
Work Procedures &Instructions
Inspection Instructions
Procedures/ Identification & Traceability, MG-08-001-P
Methods Molding Process, MG-09-005-P
Linecheck Inspection, QA-10-003-P
Final Inspection/Material Handling, QA-10-004-P
Finishing Process (Instructions in QSD)
Part Audit, ML-10-003-P
Statistical Process Control, QA-20-001-P
Equipment/ Presses and Molds
Materials Inspection & Test equipment
Computers, Scanners, Printers
Network Programs
Routers
Finishing Equipment
Process Good Product, Ready for Outbound process
Outputs
Measurement/ Molding/Total Scrap
Assessment Failures by Classifications
Customer Returns
Shipping Dollars
Manufacturing Dollars
3.5.7 Outbound Process
Outbound (Q7)
Purpose Packaging and labeling
Handling of final product
Scheduling transportation
Storing the product (ensure preservation)
Order picking
Truck loading
Coordinating delivery with customers
Owner Director of Manufacturing
Required Shipping Manager
Personnel Customer Service Personnel
Final Leadperson
Shipping Clerks
Material Handlers
Process Parts meeting all requirements
Inputs Updated Open Orders Report
Order Entry
Routing Instructions (Customer Specified)
Purchase Order
Customer Communication
Procedures/ Shipping Procedure, SR-15-001-P
Methods Control of Shipping Instructions, QA-05-009-P
Final Inspection/Material Handling, QA-10-004-P
Equipment/ Scales
Materials Tow Motor
Computer, Scanners, Printers
Network Programs
Skids & Stretch wrap
Labels
Process Organized Inventory
Outputs Packing List
ASNs
Shipping Labels
Bill of Lading
Measurement/ Customer Returns due to Shipping Issues
Assessment On-time Delivery
Delivery PR&Rs
3.5.8 Customer Satisfaction Process
Customer Satisfaction (Q8)
Purpose Analyze & track customer perceptions
Communicating perceptions to organization
Providing customer assistance
Owner Quality Manager
Sales Director
Required President / CEO
Personnel Sales/Engineering Director
Quality Systems Engineer
Process Customer feedback
Inputs
Procedures/ Customer Visits / Seminars
Methods Customer Satisfaction, AD-01-002-P
Nonconformance Control, QA-13-001-P
Control of Nonconforming Testing, ML-13-001-P
Equipment/ Telephone
Materials Computer/ Printer
Network Programs
Process Happy customers
Outputs Profitable company
Measurement/ Customer satisfaction report
Assessment Customer Returns
PPAP Approvals
3.5.9 Personnel Management Process
Personnel Management (Q9)
Purpose Determining competency needs with Leaders
Recruiting appropriate personnel
Assigning personnel to processes
Administer programs to build competence & safety
Developing policies that result in employee retention
Facilitating organizational communications
Mediating Conflict
Ensuring legal compliance
Owner Human Resource Manager
Required Director of Manufacturing
Personnel President / CEO
Manufacturing Supervisors
Process Legal Requirements
Inputs Manufacturing Needs
Procedures/ Organizational Communication Meetings
Methods Training System, ST-18-001-P
Management Review, AD-01-004-P
Internal Audit, QA-17-001-P
Equipment/ Computer/Printer
Materials Network Programs
Organizational Communication Postings
Process Competent Personnel
Outputs Policy Governing Personnel
Programs to build competency
Measurement/ Internal Audits
Assessment Management Review
Employee Turnover
3.5.10 Maintenance Process
Maintenance (Q10)
Purpose Determine & implement preventive maintenance
Schedule work in most efficient manner possible
Reacting to breakdown scenarios
Performing predictive maintenance
Optimizing infrastructure cost, timing, & effectiveness
Owner Maintenance Manager (Infrastructure/Equipment)
Advanced Technical Engineer (Tooling - In House)
Senior Tooling Engineer (Tooling - In House & Outside Tool Reparirs)
Quality Manager (Calibration)
MIS Manager (Network Systems)
Required Sales/Engineering Director
Personnel Maintenance Personnel
Manufacturing Supervisors
Tool Maintenance Personnel
Quality Technician
System Administrator
Building Maintenance Personnel
Process Maintenance Request
Inputs Preventive Maintenance Schedule/ Predictive Maintenance
Emergency Calls
Tool Maintenance Requisitions/ Required Cleaning list
Calibration Schedules
System Administration Schedules
Procedures/ Preventative Maintenance, MT-09-003-P
Methods QSR Requisition, PR-06-003-P
Maintenance Requisition, MT-09-007-P
Maintenance Key Parts Inventory, MT-09-005-P
Tool Maintenance Procedure, MG-09-002-P
Calibration Control, DL-11-001-P
Building Maintenance Program, MT-09-009-P
Continuous Improvement Project, AD-02-001-P
Computer Network Security & Maintenance, MI-05-001-P
Waste Recycling, ST-09-004-P
Equipment/ Machine Maintenance Tools/Equipment
Materials Mold Repair and Maintenance Equipment
Measuring & Test Equipment
Outside Service Suppliers
Computer w/ Network programs
System Administration Tools
Building Maintenance Equipment
Process Production-ready machines
Outputs Production-ready molds
Production-ready Measuring & Test Equipment
Reliable and User-friendly Network Systems
Productive work environment
Measurement/ Number of SPINs completed
Assessment Production Downtime Due to Equipment Failures
PM Activity Summary
Production Downtime Due to Mold Maintenance
Network Downtime Due System Failure
Number of Out-of-Calibration items
3.5.11 Improvement Process
Improvement (Q11)
Purpose Guiding the development of procedures
Managing Internal Audits
Administering corrective & preventative action
Report to leadership results of improvement efforts
Facilitating problem-solving methods & tools
Troubleshooting with customer
Assisting in improving suppliers
Guiding the use of statistical techniques
Owner Quality Manager
Director of Technology
Maintenance Manager
Required President / CEO
Personnel All directors and managers
All personnel
Process Management Review actions
Inputs Internal Audit results
Customer Input
Personnel Input
Procedures/ Nonconformance Control, QA-13-001-P
Methods Corrective / Preventative Action, QA-14- 001-P
Technical Complaints, ML-14-001-P
Internal Audit, QA-17-001-P
Document control, QA-05-006-P
Record Retention, QA-16-001-P
Continuous Improvement Project, AD-02- 001-P
Statistical Process Control, QA-20-001-P
Laboratory Statistical Process Control, ML-20-001-P
Quality Meetings
Customer Drawing Control, MG-05-002-P
Equipment/ Computer w/ Network Programs
Materials Communication Meetings
Customer Communication
Continual Improvement Program
Customer Specific Programs (Covisint)
Process Improved Systems
Outputs Improved Processes
Improved Customer Satisfaction
Measurement/ Management Review
Assessment Quality Objectives
Customer Complaint Status
3.6 PROCEDURE CROSS- REFERENCE
Procedure Name Procedure # TS 16949 Section
Document control, QA-05-006-P 4.2.3
Record Retention, QA-16-001-P 4.2.4
Business Plan, AD-01-001-P 5.4.1.1
Steering Committee, QA-02-004-P 5.4.2
Management Review, AD-01-004-P 5.6.1
Training System, ST-18-001-P 6.2
Computer Network Security &
Maintenance, MI-05-001-P 6.3
Building Maintenance
Program, MT-09-009-P 6.4.2
Advance Quality Planning, QA-02-001-P 7.1
Simultaneous Advanced
Planning, QA-02-002-P 7.1
Simultaneous Advanced
Planning, QA-02-002-P 7.2
Waste Recycling, ST-09-004-P 7.2.1
Customer Purchase Order
Review, SA-03-002-P 7.2.2
Feasibility Review, SA-02-001-P 7.2.2
Inquiry Quotation, SA-03-001-P 7.2.2
Prelaunch, EG-02-001-P 7.3
Simultaneous Advanced
Planning, QA-02-002-P 7.3
Material Development, ML-02-001-P 7.3.1
Prototype, EG-04-001-P 7.3.6.2
Production Part Approval
Process, QA-02-003-P 7.3.6.3
QSR Requisition, PR-06-003-P 7.4.2
Purchasing Control, PR-06-001-P 7.4.3
Receiving Inspection, QA-10-001-P 7.4.3
Receiving, SR-06-001-P 7.4.3
Tooling Purchase Order, EG-06-001-P 7.4.3
Premium Freight, PR-06-004-P 7.4.3.2
Vendor Control, PR-06-002-P 7.4.3.2
Molding Process, MG-09-005-P 7.5.1
Mold Setup, MG-09-003-P 7.5.1.3
Maintenance Key Parts
Inventory, MT-09-005-P 7.5.1.4
Maintenance Requisition, MT-09-007-P 7.5.1.4
Preventative Maintenance, MT-09-003-P 7.5.1.4
Tool Maintenance Procedure, MG-09-002-P 7.5.1.5
Production Scheduling, AD-15-003-P 7.5.1.6
Control of Process,
Inspection & Test
Instructions, QA-05-007-P 7.5.2
Linecheck Inspection, QA-10-003-P 7.5.2
Final Inspection/Material
Handling QA-10-004-P 7.5.2
Identification &
Traceability, MG-08-001-P 7.5.3
Customer Supplied Material, MG-07-001-P 7.5.4
Control of Shipping
Instructions, QA-05-009-P 7.5.5
Final Inspection/Material
Handling QA-10-004-P 7.5.5
Shelf Life, ML-09-001-P 7.5.5
Shipping Procedure, SR-15-001-P 7.5.5
Calibration Control, DL-11-001-P 7.6
Statistical Process Control, QA-20-001-P 8.1
Customer Satisfaction, AD-01-002-P 8.2.1
Internal Audit, QA-17-001-P 8.2.2
In-Process Material, ML-10-002-P 8.2.3
Statistical Process Control, QA-20-001-P 8.2.3
Laboratory Statistical
Process Control, ML-20-001-P 8.2.3
Final Inspection/Material
Handling QA-10-004-P 8.2.4
Part Audit, ML-10-003-P 8.2.4
Nonconformance Control, QA-13-001-P 8.3
Management Review, AD-01-004-P 8.4
Continuous Improvement
Project, AD-02-001-P 8.5.1
Corrective Action, QA-14-001-P 8.5.2
Preventative Action, QA-14-002-P 8.5.3
Technical Complaints, ML-14-001-P 8.5.2
Approved By: President / CEO
Maintained By: QUALITY MANAGER
Revision: 4
Issued: 10/29/2003
| |
![[QSR Logo]](/aqua/logo.gif){kind=logo}
![[Home]](/aqua/homeico.gif){kind=small}