Good Quantity Control Practices
Good Quantity Control Practices means that the plant managers should take all reasonable precautions to ensure the following quantity control standards or their equivalent are met:
- A formal quantity control function is in place with authority to review production processes and records, investigate possible errors, and approve, control, or reject lots.
- Adequate facilities (e.g., equipment standards and work areas) for conducting quantity control functions are provided and maintained.
- A quantity control program (e.g., a system of statistical process control) is in place and maintained.
- Sampling is conducted at a frequency appropriate to the production process to ensure that the data obtained is representative of the production lot.
- Production records are maintained to provide a history of the filling and net content labeling of the product.
- Each "production lot" contains on the average the labeled quantity, and the number of packages exceeding the specified maximum allowable variation (MAV) value in the inspection sample shall be no more than permitted in Tables 2-1 and 2-2 in NIST Handbook 133.
- Packaging practices are appropriate for specific products, and measurement procedures (e.g., quantity sampling, density and tare determinations) and guidelines for recording and maintaining test results are documented.
- Personnel responsible for quantity control follow written work instructions and are competent to perform their duties (e.g., background, education, experience and training). Training is conducted at sufficient intervals to ensure good practices.
- Recognized procedures are used for the selection, maintenance, adjustment, and testing of filling equipment to ensure proper fill control.
- Weighing and measuring devices are suitable for their intended purpose, and measurement standards are suitable and traceable to national standards. This includes a system of equipment maintenance and calibration to include recordkeeping procedures.
- Controls over automated data systems and software used in quantity control ensures that information is accessible, but changeable only by authorized personnel.
- Tare materials are monitored for variation. Label changes are controlled to ensure net quantity matches labeled declaration.