4.0 - QUALITY MANAGEMENT SYSTEMS
4.1 Quality System Processes
Rev: A --- 01/1/04 --- New
Bids, Quotations, Orders and Contracts CUSTOMER REQUIREMENTS
Human Resources Plant, Facility and Equipment Information Resources (Document Control) Communication
Planning of Product Realization Purchasing and Receiving Production
Management Policies, Planning and Commitments Management Review
MEASUREMENT ANALYSIS AND IMPROVEMENT
Monitoring/Measurement of Products Monitoring/Measurement of Quality System (QMS) Monitoring Customer ...view middle of the document...
1.4 Quality system documentation also defines criteria and methods needed to ensure that the operation and control of quality system processes are effective. This includes assignment of responsibilities and allocation of resources for the process, instructions on how to carry out (or operate) the process, and definition of methods for monitoring and/or measuring the effectiveness of the process.
1.5 Quality Manual Section 4.2 and the corresponding Operational Procedure QOP-04-01, Quality System Documentation, explain in more detail how quality system processes are defined and documented.
2.0 Resources and Information Quality Assurance manager is responsible for determining resource and information requirements necessary to support the operation and monitoring of quality system processes, and for communicating these requirements to the top management. The top management is responsible for ensuring the availability of necessary resources and information. Quality Manual Section 6.1, Provision of Resources, explains in more detail how resource requirements are identified and satisfied.
3.0 Monitoring and Measurement 3.1 Performance of quality system processes is systematically monitored and measured. This is to ensure their effectiveness and identify opportunities for improvement. 3.2 Performance of quality system processes is monitored through internal quality audits (refer to Quality Manual Section 8.2 and Operational Procedure QOP-82-02, Internal Quality Audits). The overall performance of the quality system is monitored by measuring customer satisfaction (refer to Quality Manual Section 8.2 and Operational Procedure QOP-82-01, Customer Satisfaction).
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4.0 - QUALITY MANAGEMENT SYSTEMS
3.3 Quality system processes are reviewed and analyzed by the management review of the quality system (refer to Quality Manual Section 5.6 and Operational Procedure QOP-56-01, Management Review).
4.0 Continual Improvement 4.1 Quality management system processes are regularly reviewed by the top management to identify any possible failures or breakdowns, as well as opportunities for improvement. Actions necessary to address actual or potential problems and to improve the quality system are implemented through corrective and preventive actions and through quality objectives. 4.2 Quality Manual Section 8.5 and Operational Procedures QOP-56-01, Management Review, QOP-54-01, Quality Objectives, and QOP-85-03, Corrective and Preventive Actions, define how the quality management system itself ensures its own compliance and continual improvement. 5.0 Sub-Contracted Processes 5.1 When processes that affect product conformity are outsourced, special controls are implemented to ensure that these processes meet specified requirements. Such controls may include, as appropriate:
Evaluation and pre-qualification of suppliers; Assessment of supplier realization processes and quality system; Flow-down of customer (contract)...