SECTION 9 PROCESS CONTROL
GENERAL POLICY
Production and individual operations are planned and documented. Personnel performing complex or critical operations are provided with work instructions and, when applicable, workmanship criteria. Special processes are controlled and are carried out in accordance with written procedures. Production and process equipment is checked and maintained to ensure continuing process capability. Production areas are regularly cleaned to provide a suitable production and working environment.
PROCEDURAL POLICIES
1. Production Plan (Work Order, Routing, Quality Assurance Plans)
1.1 The production plan is specified on a traveling work order prepared by the Production Control department.
1.2 The work order lists all production and inspection operations necessary to manufacture and verify products. General Process Specification G9011, Process Control, instructs in establishment and use of the work order.
2. Work Instructions (Manufacturing Process Specifications)
2.1 For complex and/or important production operations, production personnel is provided with work instructions called Manufacturing Process Specifications (MPSs). MPSs are defined by Design and Manufacturing Engineers and reviewed by the Production Manager. The criteria for evaluating when MPSs are needed, and the rules for issuing and controlling them, are stipulated in General Process Specification G9011, Process Control.
3. Process Control and Monitoring
3.1 Production processes are controlled by written process procedures, process operator training and/or certification, process equipment qualification, or continuous process monitoring and statistical analysis.
3.2 The Design and Manufacturing Engineers and the Production Manager are responsible for selecting appropriate process control methods for particular processes. Simple and verifiable processes are not formally controlled.
3.3 Special processes (the results of which cannot be verified) are always controlled, using one or several methods listed in 3.1. The QA Manager identifies and qualifies special processes. Quality Assurance Plans (QAPs) are written procedures specifying the method of process control for a particular manufacturing process. The relevant activities are regulated by General Process Specification G9011, Process Control.
4. Production Equipment and Environment
4.1 Production equipment and machines are regularly maintained following the schedules and recommendations provided by their manufacturers. Performance and accuracy of the equipment is continuously monitored. Calibration of critical measuring equipment is performed by Quality Assurance and calibration records maintained by Document Control.
4.2 Suitable production environment is ensured by proper maintenance of buildings and HVAC equipment, and by regular cleaning and clearing of the production areas.
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