Guest Column | March 1, 2017

9 Steps To Successfully Embed Quality Personnel On The Shop Floor (And Why It's Important)


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? 

  1. Ensure that the shop floor area has enough space for at least one or two quality professionals to be accessible to manufacturing staff.This includes desk space, computer access, and a place for files — providing basic office supplies makes a difference in ensuring the operation is successful.
  2. Make sure the quality group has sufficient resources (staff, etc.) to be present on the floor with operations.If your organization is small, you need to make sure that you are not spreading the quality group too thin. To maximize resources, the quality management team can assign additional responsibilities to shop floor quality employees when the manufacturing area is slow or shut down.
  3. Choose your shop floor quality professionals wisely.These individuals should have a good rapport with the operations group, knowledge of the process, and expert understanding of relevant regulations.They also should be easily approachable, good teammates, and well-versed in compliance to regulations.
  4. Create metrics that are co-owned by operations and quality. For example, create metrics regarding how many batches were made without error or how many deviations were handled weekly.
  5. Develop tools that the quality group can use to document issues or concerns, and to report on potential risk management projects.Forms can be created to track document issues, near misses with compliance, and risk mitigation efforts.
  6. Schedule recurring meetings between the necessary operations and quality staff to review documented items or upcoming corrective actions that may need review.Face-to-face meetings between the parties involved will further strengthen the partnership between quality and manufacturing.
  7. Create mission and purpose statements for this group of shop-floor quality professionals.The group needs to understand that they are not only there to ensure compliance, but also to teach and mentor the operations employees on continuing the quality culture.
  8. Draft a detailed procedure that outlines the shop floor group’s responsibilities, to ensure proper training can take place.Once the responsibilities are outlined, management should decide how many resources are needed to carry out the duties successfully.If the operations group will be manufacturing product across three shifts, quality should be there across all three shifts as well.
  9. Conduct training based on the procedure documentation. Before shop floor quality professionals are introduced onto the manufacturing floor, they should be fully trained on the processes they are about to witness and review.

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.