Q07 Manufacturing Operations in Quality Management System

Q07-0000 Manufacturing Operations in Quality Management System

The Manufacturing Operations is the core of most businesses’ quality system:

• Q07-10  Product Realization –
  • this is the planning of product objectives, resource requirements.
  • Develop a Quality Plan.
• Q07-20  Customer Requirements –
  • determine Statutory and regulatory requirements applicable to the product
• Q07-30  Product Design, Validation –
  • Plan and control the product design and development.
  • Appropriate review, verification, and validation activities for each stage
• Q07-40  Purchasing of Goods –
  • Evaluate and select suppliers based on their ability to supply product in accordance with the requirements.
  • Establish the criteria for selection, evaluation, and re-evaluation.
  • Maintain the results of the evaluations and subsequent follow-up actions.
• Q07-50  Perform & Monitor (QC) Manufacturing – Plan and carry out production and service provision under controlled conditions to include, as applicable:
  • develop product characteristics information
  • Availability of work instructions
  • Ensure suitable equipment and resource
  • Validation – Equipment Qualification, Process Validation, Cleaning Validation
  • Implementation of product release, delivery, and post-delivery activities
• Q07-70  Measuring Devices –
  • control of monitoring & measuring devices
  • Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity.
  • Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
  • Calibration program & schedules for devices
• Q07-80  Address Non-conformance