QMS Component: Systems Review
Systems Review is process embedded in the QMS to ensure the systems outlined in the document are regularly reviewed to maintain their effectiveness.
The systems review should cover the process for reviewing the systems contained in the document. For example, reviewing the process for ordering components or materials and ensuring this is still relevant and current to the design and manufacturing process. The QMS should be regularly reviewed following this process, as considered necessary by the responsible person.
Things to consider:
- Is there a ‘detailed’ review process outlined in this section of the QMS?
- What source of information (eg. customer feedback, assembly improvements, component reject rate) to consider in identifying specific area in the process/system to review?
- Who is responsible in identifying these review processes?
- Who is responsible in implementing corrections/corrective or preventive actions?
- How to ensure that the actions are measured and effective?
- Is there a schedule (eg. time table, schedule matrix) as to when to conduct the review of the systems?
- Is there a personnel (or more) identified to conduct these reviews?
- If there is process or system for external facilities (eg. overseas, other manufacturing sites, etc.), is the review outlined within this section?
