Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Unforeseen, unanticipated, unpredicted, unexpected. These are frightening words to pharmaceutical quality and compliance professionals because an unexpected event often indicates a costly, risky problem; it means that something is not completely under control.
This, of course, has regulatory implications. One familiar regulatory example is 21 CFR 211.192: “Any unexplained discrepancy…shall be thoroughly investigated…The investigation shall extend to other batches…that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”
Regulatory agencies around the globe are shifting their focus from compliance to quality, and to be even more specific, to the sustainability of quality within your organization. Is your organization’s quality system ready for the unexpected? Will it allow you to properly document, investigate, correct, or control planned and unplanned events that vary from the expected?
Manage the Unexpected
“To expect the unexpected shows a thoroughly modern intellect.”
– Oscar Wilde, Dramatist
Pharmaceutical quality professionals are trained to expect the unexpected, and it is important to have tools and processes in place to manage the unexpected when it occurs. For example, when a batch doesn’t come out as expected or when a lab result is out of specification, your team needs to know what steps to take to record a problem, understand its risk, and investigate accordingly. That’s why you have tools like Failure Mode and Effects Analysis (FMEA), procedures that detail the steps to take when a problem occurs, corrective and preventive action management processes, and change control.
Common unplanned deviations include, but are not limited to:
- Malfunctioning equipment
- Instrument breakdown
- Utility or service failure
- Human error
- Yield deviation
Managing these quality processes – which ideally integrate with and trigger one another – in manual or siloed systems becomes tricky. It’s difficult to ensure that the right steps are consistently taken to resolve a problem, and this consistency is critical to maintaining quality and compliance. Whether you’re recording a deviation, out of specification result, customer complaint, or a planned change, each must be carried out in a harmonized way to ensure ongoing improvement.
Measure the Unexpected
An Enterprise Quality Management System (EQMS) provides integrated, automated processes to manage and then correct when appropriate, the unexpected, smoothly and consistently. The goal of EQMS is to improve quality and efficacy thereby improving patient safety and satisfaction. One of the ways EQMS does this is by turning data into information. Codified EQMS data allows for the delivery of reports and analytics that measure the unexpected, and turn that data into actionable information. EQMS ensures:
- Consistent data capture for key elements such as failure mode, product, risk, and root cause.
- Data analysis and threshold alerts to understand ongoing results and trends, identifying systemic problems that need correction and prevention.
“Any enterprise CEO really ought to be able to ask a question that involves connecting data across the organization, be able to run a company effectively, and especially to be able to respond to unexpected events. Most organizations are missing this ability to connect all the data together.”
– Tim Berners-Lee, Inventor
In addition, the Center for Drug Evaluation and Research (CDER) has begun focusing on product quality and the effectiveness of manufacturing at the site level. The metrics that CDER intends to focus on are:
- Lot Acceptance Rate
- Product Quality Complaint Rate
- Invalidated Out of Specification (OOS) Rate
- Annual Product Review
- Additional metrics being assessed include CAPA Effectiveness and Process Capability
Prevent the Unexpected
Documenting and analyzing the unexpected can serve as the platform for organizational improvement and prevention. Once you’re able to consistently manage and measure the unexpected within your organization, it’s time to move to the next step – prevention and ultimately prediction. While you can’t prevent every defect, you can minimize scrap and wasted batches, improve Yield, increase product compliance, improve Overall Equipment Effectiveness, and reduce errors by using data from unexpected events to predict and prevent future problems, while identifying opportunities for improvement across the extended enterprise.
“One should expect that the expected can be prevented, but the unexpected should have been expected.”
– Norman Ralph Augustine, Author
Are you ready to use the unexpected to drive continuous improvement? Join us for an upcoming webinar to learn how managing and measuring the unexpected will benefit your organization.
Are You Ready for the Unexpected?
Learn how to manage, measure, and prevent unexpected quality events.