Review of Quality Management system

1. Whether formal documented instructions / procedures are available on:

I. Quality tests to be performed at each stage of the production process

II. Steps to be taken in the case of negative results

III. Documentation required to evidence completion and results of quality checks

2. Whether sufficient quantities of each production run are tested to enable compliance with quality control standards

3. Whether Quality assurance procedures are integrated into the production process.

4. Whether defect rates, customer returns and complaints due to poor quality are monitored.

5. Whether measuring equipment and devices are calibrated on a periodic basis i.e. quarterly, half yearly.