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The quality of pharmaceuticals is a major concern in the pharmaceutical industry. The quality of the product indicates the importance of the manufacturer for patient safety. This means that defects in the quality of the product can harm the user of the product.
Low quality products are not accepted on the regulated market and should not be accepted anywhere as they may harm the user. The best way to achieve optimum product quality is to develop a culture of quality in the manufacturing facility. All employees must be quality conscious and quality must be in the blood of all workers in the organization, from a worker to top management.
First, a gap analysis is needed to determine the current state of the company in terms of quality. Some questions can be asked, such as: What is the current state of the quality culture in other departments, including the QC lab, shop, warehouse, and office? What does the company want to achieve? A set of objectives can help the company build a solid foundation for a culture of quality.
After answering these basic questions, plant personnel must discuss quality improvement needs. There should also be a discussion between top management and decision makers about improving the culture of quality in the workplace.
Top management must demonstrate its commitment to quality to its subordinates to develop a culture of quality among employees. This will send a message to all employees to be strict about product quality. Involving managers on the shop floor can help achieve better results. A schedule must be developed for inspecting the production floor and talking with employees about quality improvement. After a short time, employees begin to see that management is serious about quality.
Employee engagement helps build a culture of quality. Employees are not only appreciated with their promotion or bonus but also feel appreciated when their opinion is taken for any improvement. They feel belonging and attachment to the company and that will make them commit to building a quality culture.
In general, employees in all departments try to find work shortcuts that compromise quality. People must be trained to achieve the quality objectives of the company. From my personal experience in the pharmaceutical field, the main reason for shortcuts is workload. Most pharmaceutical companies have labor shortages and this creates additional workload for employees. Top management must provide adequate staff to all departments for smooth operation.
Process and method changes are regular in pharmaceuticals. Employees must be trained for regular cGMP updates. Changes to guidelines, documentation, and SOPs must be properly communicated to the end user. A knowledgeable employee will never deviate from any process and will always act as a loyal soldier.
A successful quality culture cannot be built in a day, but rather takes time and a commitment to quality from top management down to plant employees. After a short time, everyone benefits from the commitment to quality when a quality culture is developed in the company.
