Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Unforeseen, unanticipated, unpredicted, unplanned, unexpected. These words are typically undesirable descriptors of actions or events. Among Pharmaceutical quality and compliance professionals, they elicit downright fear because the occurrence of an unexpected event signals that something in their organization’s processes or procedures is not completely under control, and detrimental impact to patient safety is likely. For this highly regulated industry, such occurrences carry regulatory implications.
One associated regulatory standard, the FDA’s 21 CFR 211.192, states: “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.”
EudraLex, The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the World Health Organization (WHO), and other agencies around the globe have standards and guidances that reflect the same.
Regulatory bodies around the globe are increasingly shifting their focus from compliance to quality, and more specifically, to the sustainability of quality within Pharmaceutical organizations. This means that your organization’s quality system needs to be ready to manage the unexpected.
But how does one manage what it doesn’t anticipate? By properly documenting, investigating, and correcting unplanned events that vary from the expected. Additionally, it should allow for preventive actions to minimize or eliminate the risk of re-occurrence.
Manage the Unexpected
“To expect the unexpected shows a thoroughly modern intellect.” ~ Oscar Wilde, Dramatist
Pharmaceutical quality professionals are trained to anticipate 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, when documented procedures aren’t followed, or a process fails to complete as expected, your team needs to know what steps to take to record the 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
- Unapproved changes to processes or product ingredients
- Operating outside of defined limits
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 other quality event, each must be carried out in a harmonized way to ensure ongoing improvement.
Measure the Unexpected
An enterprise Quality Management System (QMS) provides integrated, automated processes to manage, correct, and when possible, prevent the unexpected, smoothly and consistently. The ultimate goal of a QMS is to improve quality and efficacy through continuous improvement, thereby improving patient safety and satisfaction. One of the ways EQMS does this is by turning data into information. Harmonized, codified QMS data allows for the delivery of reports and analytics that adequately measure the unexpected turning that data into actionable information.
A QMS 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
Play a Role in Setting the Industry’s Yardstick
The Center for Drug Evaluation and Research (CDER) has recently begun focusing on Pharmaceutical product quality and the effectiveness of manufacturing at the site level. The metrics under review are:
- Lot Acceptance Rate
- Product Quality Complaint Rate
- Invalidated Out-of-Specification (OOS) Rate
- Annual Product Review
- CAPA Effectiveness
- Process Capability
This program is still in pilot mode, which means there is still time for your organization to impact this program. If you join the pilot program now, your organization will be ready when the new measurements are required.
Beyond the compliance implication, documenting and analyzing the unexpected can serve as the platform for organizational and product improvement, and risk prevention as well.
Prevent the Unexpected
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, and product compliance, improve Overall Equipment Effectiveness, ensure supply chain safety, and reduce errors by using data from unexpected events to predict and prevent future problems while identifying opportunities for improvement across the extended enterprise.
“If history repeats itself, and the unexpected always happens, how incapable must Man be of learning from experience.” ~ George Bernard Shaw, Playwright
Is your organization ready to learn from history and use the unexpected to drive continuous improvement?
Are You Ready for the Unexpected?
Learn how to manage, measure, and prevent unexpected quality events.