Production and Process Control

We design quality into our products. Areas of the manufacturing process that require control are identified during the development of a product and the effects of variables and appropriate limits are established.

Process Control is accomplished through planning, written procedures, inspection, calibration, training, supervisory oversight and employee awareness. Changes to the manufacturing process, if required, are controlled, qualified and validated.

• Written procedures provide bills of materials, instructions for production, equipment required, working environment, filling and labeling instructions, record sheets, expiration dating, in-process testing, and acceptance criteria. 
• Monitoring of product manufacture is accomplished through the use of (Device History Records) containing the current revisions of the documents required for the manufacture of a product. Document Control assembles batch records for kit component manufacturing. Other manufacturing and Quality Control departments print official copies of their documents from Master Control. Operations, in production, assembles the batch records. Quality Control verifies compliance through review and approval of completed  records prior to final product release. 
• The Specification Deviation Procedure handles deviations from the written procedures. 
• All new inspection, measuring and test equipment is inspected and validated, when appropriate, against manufacturer’s specifications and identified with a permanent preventive maintenance number. Equipment is calibrated on a regular schedule. Improperly maintained or calibrated equipment will not be used. Records of calibration and maintenance are maintained by the Facilities & Equipment Department. Quality Assurance audits equipment periodically, to ensure that calibration is proceeding according to schedule. 
• The supervisor or lead personnel contributes to quality through training employees, assisting employees with new or specialized processes, interpreting instructions for and communicating process changes to employees.

Related Procedures:

• Specification Deviation Procedure.
• Procedure for Documentation of Equipment Maintenance and/or Calibration. 
• Software Validation. 
• Internal Notification Procedure: Receipt of New Equipment. 
• Planning Guidelines, Immunoassay Manufacturing.
• Recipe Authorization. 
• Copy and Maintain a Process Specification 
• Adding and Copying a Recipe 
• Product Finishing Label Control 
• Filling Operations Procedure 
• Preparation, Completion and Approval of  Records 
• Incoming Equipment Validation Procedure 
• Process Deviation Form, (on related Depertement) 
• Product Finishing Label Control 
• Packing Procedure 
• Finished Device Inspection Procedure 
• Guideline for Determining Assay Ranges 
• Testing Protocol Request 
• Product Type, Product Type Revision, Product Change Notification