Isn’t customer satisfaction the ultimate goal of every company? It certainly is, and this is equally true for companies in the Life Sciences sector, as for those in any other business sector. However, what must Biopharmaceutical companies do to continually enhance customers’ experience and satisfaction? They need to consistently provide:
- A product that is safe and effective.
- A product that is delivered on time to meet their needs.
- An efficient and agile support system for resolution of unexpected situations.
These elements strongly resonate with having a robust Quality Management System (QMS) in place, i.e. a system to manage the quality of your products.
A Quality Management System (QMS) is defined as a formalized structure that documents the processes, procedures, and responsibilities for achieving quality policies and objectives.
A robust QMS – not just any QMS – is the vehicle that allows organizations to coordinate and direct the activities that will meet customer and regulatory requirements. Those regulatory requirements are translated into policies and procedures to ensure that every time a process is performed, the same information, methods, skills, and controls are used and applied in a consistent manner.
A QMS is not simply a set of documents, but rather a methodology which allows for the identification of any deviation or unexpected event during the execution of the process steps. These events can then be fed into the system to ensure continuous improvement. Such a system also provides for having appropriate process inputs rather than dealing with procedures to address process outputs (i.e. deal with procedures to produce a compliant product, as opposed to only focusing on the processes to inspect non-conforming products).
What’s more, having a formally established QMS provides businesses with a unique opportunity to involve the entire organization (each department and each person at each level) in achieving quality requirements. Your employees are the front line of your quality system, so engaging them is key; if your staff is involved, they are more likely to take ownership of the QMS and hold each other accountable. In essence, you are adding a quality mindset to your QMS methodology.
Finally, the right QMS design is a combination of flexibility and standardization – organizations need enough standardization to produce consistent results and enough flexibility for continuous improvement, thus creating a quality-driven culture.
Besides assisting your organization in boosting your customer satisfaction levels, this framework will:
- Ensure your products are manufactured right-the-first-time, thus delivering within the time expected and required by patients (remember Customer Satisfaction?).
- Ensure you are compliant from a regulatory standpoint, thus meeting your customer (patient) requirements.
- Increase the engagement and knowledge of your staff, thus helping to implement improvements and respond timely to complaints.
As important as a Quality Management System (QMS) is for every company at any stage within their product lifecycle, many businesses still find it challenging to implement and maintain. Fortunately, PharmaLex has extensive experience and a proven track record in providing experts to act as QA support resources that will help develop, implement, and maintain a robust and phase appropriate QMS program.
We look forward to further discuss how PharmaLex can assist you!