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You Can't Distance From Quality

By David Shenberger , June 15, 2020

As an essential business, which must continue functioning in the current global environment, Pharmaceutical Manufacturing companies face unique challenges. Pharmaceutical Manufacturing relies on operating in a controlled state, which stems from Quality Systems in six significant areas. With the current COVID-19 outbreak, this may require adjustments to the way the plant operates typically. Decisions require a scientifically sound process.

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The scientifically sound process includes a strong reliance on product and process data, engineering expertise, and using all of this to inform risk-based decision making. The coronavirus pandemic has put into stark relief the need for business continuity planning to support quality operations and maintain control of manufacturing.

We are focused on product quality, compliant operations, reducing lifecycle cost, having high overall equipment effectiveness, all while protecting our employees’ health. When we’re focused on manufacturing continuity with limited access from our suppliers and contractors, only essential personnel onsite, and a fraying supply chain still meeting these objectives are critical to our success but very difficult to do in practice.

Our risk control strategy has to take into account Manufacturing Science and Technology, Facilities, IT, and Equipment, Quality Control, QA and Regulatory Compliance, Operations and Environmental, Health, and Safety, Organization and Talent, and Supply Chain. We then look at the three types of controls, technical, behavioral, and procedural, and determine the proper way to manage the identified risks.

Technical controls construct barriers to the introduction of risks.  These include system access controls, equipment interlocks, etc. Procedural controls are written standards that set the rules and guidance for behaviors, but they are NOT behavioral controls. Behavioral controls work to set the conditions for humans to perform predictably. This means performing with fewer errors and less temptation to violate procedures.

When behavior is a problem, technical and procedural controls may help make someone pause before proceeding in the wrong direction, but if someone’s mind is made up, these other controls may not be sufficient. Other behavioral controls include strong supervisory skills, role clarity, transparency in communication, a CADENCE of communication as well as a structured, engaging, inclusive continuous improvement program. These all act as risk controls to inspire predictable behaviors. It’s critical to understand how the workplace inspires or detracts from high-performance behaviors.

So, after we look at each area and identify risks and mitigation strategies, what risks can we take, and what modifications can we make?

For example, we don’t have the QC techs (or we need to distance from operators) to execute all of Environmental monitoring, water sampling, and other activities required for compliance. Can we review the data and extend sampling times, reduce the frequency or eliminate points, rely on conductivity, online TOC, or other automation, or increase the frequency of certain sanitization activities?

From a maintenance and calibration perspective: Can we shift some maintenance tasks to the operators? Can we defer PM or calibration activities based on process history, predictive maintenance data (oil analysis, vibration, etc.), other process indications, etc.? Is every calibration or maintenance item necessary based on our risk control strategy?

Effectively communicating with our teams will be a crucial way we can control manufacturing quality. Virtual pre-shift briefs need to involve each person, set daily goals, confirm understanding, review the quality objectives, and emphasize what’s important for the day. Can we drive engagement with our remote teams to work on improvement tasks such as risk assessments, skills training, and updating SOPs and batch records to reduce deviations and improve compliance?

Business continuity planning requires strong coordination and involvement of subject matter experts and stakeholders allow with operational data and history to drive data-based planning and decision making. Some key discussion points should include inventory and supply change management, Staffing support and protection, pre-planned emergency procedures for evacuation and remote work, and energy redundancy and back up discussions.

Goals should be clear in terms of what we want to accomplish. Do we want to be able to protect our in-process batches, or do we want to continue to manufacture uninterrupted? This then should drive the answers to the questions above and the planning which needs to be in place.

Remember, you can’t distance from Quality!

 


About the Author

Shenberger, DavidDavid Shenberger is an experienced Project Manager, computer systems validation auditor, and technical expert. He has over 23 years’ experience in the pharmaceutical and biotechnology industries specifically in the areas of process control systems and computer system validation and has worked extensively on corporate quality systems. He has managed significant projects in commissioning and qualification, as well as control systems startup. He has wide-ranging test execution and project management experience with a wide variety of systems and equipment.

Topics: GENERAL, Qualification and Validation, Risk-Based Approach, CQV, Quality