RAW MATERIAL, PROCESS, and PRODUCT CONTROL

  • Are the parameters of the tolerances displayed on the QC monitoring forms?

  • Are the QC monitoring forms completed correctly?

  • Is there a Certificate of Analysis on all ingredients received?

  • Are all batches and products produced within the standard specifications?

  • Are all ingredients within the expiration date and FIFO?

  • Are all raw materials inspected, approved, and documented?

  • Does the written procedure cover all aspects of the process?

  • Is the process preventative controls in place?

  • Are all equipments working properly?

DOCUMENT CONTROL

  • Are all policies and procedures reviewed annually?

  • Are the procedures on the document followed and correctly implemented?

  • Is there a collection of QC inspection monitoring data and trend analysis?

  • Are the procedures, specifications, and standards the current version?

  • Are rejected raw materials and finished products documented and reviewed?

  • Are Suppliers Performance reviewed and documented?

  • Are the Preventive Maintenance documented and reviewed?

  • Are customer complaints documented with trend analysis?

  • Are audit non-conformances reviewed with root cause analysis and corrective actions?

  • Are product specifications reviewed and agreed prior to implementation?

FACTORY FLOOR/AREA

  • Is the training matrix under document control?

  • Is there a quality policy displayed in the area?

  • Is there a process flow of the area displayed?

  • Is there any data displayed showing how the company/area is performing?

  • Are quality objectives displayed in the area?

  • Are manufacturing specifications visible/ available to the employees?

  • Is there information/minutes displayed on Quality Meetings held?

CALIBRATION

  • Does the area have any equipment used for checking products?

  • Is the equipment in suitable state to conduct these checks?

  • Has the company provided the equipment?

  • Is the equipment on the calibration register?

  • Is the equipment within it's calibration period?

TRAINING

  • Is there a record of the Quality Policy being briefed to all employees?

  • Is it the current revision?

  • Is there a training matrix available?

  • Has training been conducted on the Quality?

  • Name of Employee?

  • Is the person on the training matrix?

  • Has the person been trained on the task they are performing?

  • Does the training have a review date stated?

  • Has the training document been signed by both Employee and Trainer

  • Does the employee know how to check the product and what to look for?

  • Name of Employee?

  • Is the person on the training matrix?

  • Has the person been trained on the task they are performing?

  • Does the training have a review date stated?

  • Has the training document been signed by both Employee, and Trainer

  • Does the employee know how to check the product and what to look for?

  • Manager of Area

  • Auditor

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