How to Maximize Pharmaceutical Manufacturing Quality From Your Employees

Posted by David Watt

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In pharmaceutical manufacturing, a number of measurable factors affect quality. An organization can invest in state-of-the-art facilities, robust operating procedures and a sophisticated IT infrastructure, but it should also keep in mind that employees’ roles, responsibilities and the organizational structure play a large part in manufacturing success.

Hire the Right People

The right people in the right roles can help drive simple changes that yield significant process improvements. For example, when the OEE (overall equipment effectiveness) on our tablet coater was only 25 percent, we hired a manufacturing engineer who observed that after room setup, solution preparation and two-, four-, or six-hour mixing times, the tablet coater was used only at the very end of the 10-hour shift. We adjusted the shift workflow so solution preparation could take place while the prior batch was being coated, resulting in a more efficient use of the tablet coater.

Create a Quality Culture

Assessment Qualification with a CMO PartnerAt its core, an organization’s QA/QC (quality control/quality assurance) teams play a vital role in manufacturing success. The quality control team ensures that good manufacturing processes occur on the floor — for example, that lot codes are legible on bottles and that the reject rate isn’t above the compliance level. The quality assurance group completes paperwork and documentation to ensure that all regulatory affairs are in order. 

True quality is about more than departmental responsibilities, however. It involves establishing a smooth workflow among all departments and a collaborative environment where employees feel ownership over processes and outcomes. Through open communication, employees can develop shared understandings of risks, errors and their potential impact, reflecting a culture of quality beyond compliance.

Creating a culture of quality can have a bottom-line impact on productivity and efficiency. According to a 2014 Harvard Business Review article, employees who ranked their company in the top quintile in terms of quality reported addressing 46 percent fewer mistakes in their daily work than employees in bottom-quintile companies. Consequently, companies with highly developed quality cultures spend significantly less time and resources on fixing mistakes and problems.

Retain Key Employees

When the right people are in the right roles and they’re embracing a culture of quality, it’s important that they stay. Manufacturing drug products to exact standards requires employees with a high level of technical knowledge. Through attrition, an organization loses specialized skill sets and must bring in new people while still keeping pace with all manufacturing, compliance and client commitments. To increase retention, they must find measurable ways to assess well-being and ask employees to share their priorities.

Also, manufacturers should consider adding a career planning component to the performance evaluation process. Whatever the approach, it’s important to provide continuous opportunities for training, coaching and advancement. Certain aspects of quality culture — transparency, feedback, shared ownership of outcomes — will also figure prominently in human resource strategies.

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Topics: quality, Corporate Culture, pharmaceutical manufacturing, employee retention

David is the Technical Director in the Business Development Department at WellSpring, and has over twenty years of pharmaceutical GMP experience in technical definition and evaluation of Contract Development and Manufacturing projects, both from provider and client perspectives. David has previously worked at Valeant, Medicis, Patheon and Syntex Pharmaceuticals. David is responsible for overseeing all technology transfer activities in the organization.

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