By Danielle DeLucy, ASA Training & Quality Consulting, LLC
It’s Saturday night in a pharmaceutical manufacturing facility, around 11:30 pm, when the alarm goes off in the aseptic processing area. There has been a positive pressure breach, and the area is compromised. The manufacturing staff quickly closes the product tank and moves it to the proper storage area. But what should happen next? There are no quality personnel on the shop floor over the weekend, so no one is present to review the containment actions taken or to discuss what the next steps should be from a compliance perspective.
Believe it or not, this is a common scenario at many pharmaceutical/biological facilities. With the ever-increasing demands for more product, firms are implementing three-shift operations to keep up. However, they are not scaling their quality staff or quality presence to keep up with the increased manufacturing activity.
It is a regulatory requirement to have a quality unit in place to oversee all aspects of a manufacturing organization. But how that quality unit should be rolled out is open to interpretation, and each approach has its own strengths and weaknesses. Having a group of qualified individuals to review standard operating procedures and corrective action plans, and to conduct deviation investigations and periodic audits, sometimes isn’t enough. The integration of a shop floor quality unit into manufacturing operations is extremely beneficial for continuously improving quality culture.
However, embedding a quality unit or group on the shop floor can face adversity from manufacturing groups. Sometimes they feel threatened or untrusted by their quality colleagues, and/or view them as “spies” sent to be management’s eyes and ears at the plant. However, when a shop floor quality unit is properly rolled out, these preconceived notions can be easily dispelled and the group successfully integrated. With regulators imposing higher expectations on the quality unit, it is imperative for firms to determine if they are, in fact, overseeing the processes that they are required to supervise.
Tips For Successful Integration
The success or failure of the shop floor quality group rollout hinges on how management presents the change to the shop floor operators. The change should be presented as a way to continuously improve the level of quality and compliance within an area, as well as a means for operations and quality to better understand one another. In many firms, there is a distinct line drawn between these two groups, which can make it difficult for the two teams to work effectively together.
So, what are the first steps to a successful integration?
Collaboration Yields Real Benefits
Shop floor quality provides the operations group with unparalleled access to a live quality staff to help address emergencies, potentials issues, questions, and even document reviews.By having a shop floor quality group embedded with operations, efficiency improvements become easy.Deviations can be discussed on the floor, containment actions agreed to in real time, outlines for corrective actions worked on more quickly, and documents reviewed and approved in a more timely fashion.
In addition, having quality on the shop floor ensures that the quality group will have a robust understanding of the processes they are reviewing.Many firms have quality groups that are so focused on reviewing deviations, corrective and preventative actions (CAPAs), and documents that they miss the opportunity to see actual processes in action.By seeing the process in real time, as opposed to after a deviation occurs, the quality unit can develop a firm grasp of the process, immediately answer compliance-related questions, and otherwise provide much needed quality support to the manufacturing staff.
Finally, one benefit that is rarely mentioned is the partnership and respect that it engenders between the operations and quality departments.Mentorship and knowledge transfer between these two groups grows exponentially as quality is embedded in the manufacturing environment.While the quality group maintains its independence and objectivity, it also gains a better understanding of the trials and tribulations that its operations colleagues face on a daily basis.Likewise, operations witnesses the fine line quality has to walk between ensuring compliance to regulations and keeping business goals in mind.Breaking down the manufacturing and quality siloes benefits the firm by streamlining the risk management, deviation, and CAPA process.By having these groups work more closely together, risks are assessed more quickly, deviation reports are more robust, and product quality is improved.
About The Author:
Danielle DeLucy is owner of ASA Training and Consulting, LLC, which provides pharmaceutical- and biologics-based companies with training and quality systems assistance in order to meet regulatory compliance. Prior to this role, she spent 15 years in the industry serving in numerous quality management roles. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters or consent decrees, and those wishing to improve compliance, establish more robust quality systems.