Internal Quality Audit

• Document No. QCF.QC Audit 01 Bldg. 840, 850, 884, 1144, 1167

• Quality Control Audit

• Follmer Development, Inc.

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

RAW MATERIAL, PROCESS, and PRODUCT CONTROL

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

  Compliant

  Observation

  Minor

  Major

• Are the QC monitoring forms completed correctly?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

• Are all ingredients within the expiration date and FIFO?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

• Is the process preventative controls in place?

  Compliant

  Observation

  Minor

  Major

• Are all equipments working properly?

  Compliant

  Observation

  Minor

  Major

DOCUMENT CONTROL

• Are all policies and procedures reviewed annually?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are Suppliers Performance reviewed and documented?

  Compliant

  Observation

  Minor

  Major

• Are the Preventive Maintenance documented and reviewed?

  Compliant

  Observation

  Minor

  Major

• Are customer complaints documented with trend analysis?

  Compliant

  Observation

  Minor

  Major

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

  Yes

  No

  N/A

• Are product specifications reviewed and agreed prior to implementation?

  Compliant

  Observation

  Minor

  Major

FACTORY FLOOR/AREA

• Is the training matrix under document control?

  Compliant

  Observation

  Minor

  Major

• Is there a quality policy displayed in the area?<br>

  Compliant

  Observation

  Minor

  Major

• Is there a process flow of the area displayed?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

• Are quality objectives displayed in the area?

  Compliant

  Observation

  Minor

  Major

• Are manufacturing specifications visible/ available to the employees?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

CALIBRATION

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

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

• Has the company provided the equipment?

  Compliant

  Observation

  Minor

  Major

• Is the equipment on the calibration register?

  Compliant

  Observation

  Minor

  Major

• Is the equipment within it's calibration period?

  Compliant

  Observation

  Minor

  Major

TRAINING

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

  Compliant

  Observation

  Minor

  Major

• Is it the current revision?

  Compliant

  Observation

  Minor

  Major

• Is there a training matrix available?

  Compliant

  Observation

  Minor

  Major

• Has training been conducted on the Quality?

  Compliant

  Observation

  Minor

  Major

• Name of Employee?

• Is the person on the training matrix?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

• Does the training have a review date stated?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

• Name of Employee?

• Is the person on the training matrix?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

• Does the training have a review date stated?

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

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

  Compliant

  Observation

  Minor

  Major

• Manager of Area

  Sign

• Auditor

  Sign