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Table Of Contents

Approvals:
Overview of TT electronics / OPTEK
1 Management Processes
1.1 Quality Management System Implementation & Maintenance
1.1.1 QMS General Requirements
1.1.2 Management Commitment
1.1.3 Customer Focus
1.1.4 Quality Policy
1.1.5 Quality Management System Planning
1.1.6 Responsibility and Authority
1.1.6.1 Responsibility for quality
1.1.6.2 Departmental responsibility for quality
1.1.6.3 Individual responsibility
1.1.7 Management Representative
1.1.7.1 Customer representative
1.1.8 Provision of Resources
1.1.9 Human resources - General
1.1.9.1 Competence, awareness and training
1.1.9.2 Product design skills
1.1.9.3 Training
1.1.9.4 Training on the job
1.1.9.5 Employee motivation and empowerment
1.1.10 Planning of Product Realization
1.1.10.1 Planning of product realization - Supplemental
1.1.10.2 Acceptance criteria
1.1.10.3 Confidentiality
1.1.10.4 Change control
1.2 Management Review
1.2.1 General - Quality Management System Performance (Mgmt. Review)
1.2.1.1 Review Input
1.2.1.2 Review Output
1.2.2 Quality Objectives
1.2.3 Measurement Analysis & Improvement - General
1.2.3.1 Identification of Statistical Tools
1.2.3.2 Knowledge of Basic Statistical Concepts
1.2.4 Customer Satisfaction
1.2.5 Analysis and Use of Data
1.2.6 Continual Improvement
1.3 Communication
1.3.1 Internal Communication
1.3.2 Customer Communication
1.4 Internal Auditing
1.4.1 Internal Audit of the Quality Management System
1.4.2 Internal Audit Plans
1.4.3 Internal Auditor Qualification
1.4.4 Manufacturing Process Audit
1.4.5 Product Audit
1.5 Corrective & Preventive Action
1.5.1 Corrective Action
1.5.1.1 Problem Solving
1.5.1.2 Error-Proofing
1.5.1.3 Corrective Action Impact
1.5.1.4 Rejected Product Test / Analysis
1.5.2 Preventive Action
2 Realization Processes:
2.1 Requirements Determination & Review
2.1.1 Determination of requirements related to product
2.1.2 Review of Requirements Related to Product, Manufacturing Feasibility
2.2 Design & Development
2.2.1 Design and Development
2.2.2 Design and Development Planning
2.2.3 Multidisciplinary Approach
2.2.4 Design and Development Input
2.2.5 Special Characteristics
2.2.6 Design and Development Output
2.2.7 Design and Development Review, Monitoring
2.2.8 Design and Development Verification
2.2.9 Design and Development Validation
2.2.10 Prototype Program
2.2.11 Product Approval Process
2.2.12 Control of Design and Development Changes
2.3 Purchasing
2.3.1 Purchasing Process
2.3.2 Regulatory Conformity
2.3.3 Supplier Quality Management System Development
2.3.4 Customer-Approved Sources
2.3.5 Purchasing Information
2.3.6 Verification of Purchased Product and Incoming Product Quality
2.3.7 Supplier Monitoring
2.4 Facilities & Equipment Management
2.4.1 Infrastructure
2.4.1.1 Plant, facility and equipment planning
2.4.1.2 Contingency plans
2.4.2 Work Environment
2.4.2.1 Work Environment
2.4.2.2 Personnel Safety to Achieve Product Quality
2.4.2.3 Cleanliness of Premises
2.4.3 Customer Property
2.4.3.1 Customer Property
2.4.3.2 Customer Owned Production Tooling
2.4.4 Control of Monitoring & Measurement Devices
2.4.4.1 Control of Monitoring and Measuring Devices
2.4.4.2 Measurement System Analysis
2.4.4.3 Calibration / Verification Records
2.4.4.4 Laboratory Requirements
2.4.4.4.1 Internal Laboratory
2.4.4.4.2 External Laboratory
2.5 Company Control Specifics
2.5.1 Document Control
2.5.1.1 Control of Documents and Engineering Specifications
2.5.2 Records Control
2.5.2.1 Control and Retention of Records
2.5.3 Control of Production Provision
2.5.3.1 Control of Production
2.5.3.2 Control Plan
2.5.3.3 Work Instructions
2.5.3.4 Verification of job set-ups
2.5.3.5 Preventive and Predictive Maintenance
2.5.3.6 Management of Production Tooling
2.5.3.7 Production Scheduling
2.5.3.8 Feedback of Information
2.5.5 Identification of Traceability Identification and traceability
2.5.6 Preservation
2.5.6.1 Preservation of Product
2.5.6.2 Storage and Inventory
2.5.7 Monitoring & Measuring of Processes
2.5.8 Monitoring & Measuring of Product
2.5.9 Control of Nonconforming Product
2.5.9.2 Customer Waiver
Approvals & Revision History
Appendix A: ISO/TS Cross Reference to this Manual
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Published by: Tania_STV on Aug 20, 2011
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