By applying metrics consistently within the organization, companies can set up systems for monitoring and control which can help to reduce the likelihood of quality incidents from happening. The application of quality tracking can assist the organization to be more in control of its people, products, and processes.
Many manufacturing establishments currently use quality metrics as a part of the process validation lifecycle and pharmaceutical quality system (PQS). Adopting metrics also makes operational sense: most drug shortages stem from quality issues (e.g., substandard manufacturing facilities or processes, or significant quality defects are identified in the finished product).
Metrics will help to tell the organization:
- Where it has been.
- Where it is heading.
- Whether something is going wrong.
- When the organization reaches its target.
When setting metrics, these should be appropriate. Manufacturers should have extensive knowledge about critical product and process parameters and quality attributes. On this basis, pharmaceutical manufacturers should strive for continuous improvement. Here the SMART mnemonic can be useful:
- Specific – target a specific area for improvement.
- Measurable – quantify or at least suggest an indicator of progress.
- Assignable – specify who will do it.
- Realistic – state what results can realistically be achieved, given available resources.
- Time-related – specify when the result(s) can be achieved.
The selected set of quality metrics should be designed to support the aim of achieving enhanced product quality without the need for extensive regulatory oversight and ultimately help to drive responsibilities for the manufacturers that lead to a reduction in product-related shortages and quality related recalls.
An example of a quality metric is the ‘Product Quality Complaint Rate’, used as an indicator of patient or customer feedback. This could be set as the number of product quality complaints received for the product divided by the total number of dosage units distributed in the current reporting timeframe. The metric could be broken down to include the number of product quality complaints received for the product or with the total number of dosage units distributed for the product.